Coffein medipharma

Coffein medipharma may be available in the countries listed below.

Ingredient matches for Coffein medipharma

Caffeine

Caffeine is reported as an ingredient of Coffein medipharma in the following countries:

• Finland

International Drug Name Search

Bornaprine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N04AA11

CAS registry number (Chemical Abstracts Service)

0020448-86-6

Chemical Formula

C21-H31-N-O2

Molecular Weight

329

Therapeutic Category

Treatment of Parkinson's disease

Chemical Name

Bicyclo[2.2.1]heptane-2-carboxylic acid, 2-phenyl-, 3-(diethylamino)propyl ester

Foreign Names

• Bornaprinum (Latin)
• Bornaprin (German)
• Bornaprine (French)
• Bornaprina (Spanish)

Generic Name

• Kr 399 (IS)

Brand Names

• Sormodren
  Abbott, Austria; Abbott, Germany; Abbott, Turkey; Teofarma, Italy

International Drug Name Search

Glossary

IS	Inofficial Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Povidone iodée Merck

Povidone iodée Merck may be available in the countries listed below.

Ingredient matches for Povidone iodée Merck

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Povidone iodée Merck in the following countries:

• France


• Tunisia

International Drug Name Search

Perindal

Perindal may be available in the countries listed below.

Ingredient matches for Perindal

Indapamide

Indapamide is reported as an ingredient of Perindal in the following countries:

• Bangladesh

Perindopril

Perindopril is reported as an ingredient of Perindal in the following countries:

• Bangladesh

International Drug Name Search

Monofree Cyclopentolaat HCl

Monofree Cyclopentolaat HCl may be available in the countries listed below.

Ingredient matches for Monofree Cyclopentolaat HCl

Cyclopentolate

Cyclopentolate hydrochloride (a derivative of Cyclopentolate) is reported as an ingredient of Monofree Cyclopentolaat HCl in the following countries:

• Netherlands

International Drug Name Search

Bioprexanil

Bioprexanil may be available in the countries listed below.

Ingredient matches for Bioprexanil

Perindopril

Perindopril is reported as an ingredient of Bioprexanil in the following countries:

• Slovenia

International Drug Name Search

Prexum

Prexum may be available in the countries listed below.

Ingredient matches for Prexum

Perindopril

Perindopril is reported as an ingredient of Prexum in the following countries:

• Indonesia

Perindopril erbumine (a derivative of Perindopril) is reported as an ingredient of Prexum in the following countries:

• South Africa

International Drug Name Search

Amoxicilline / Acide Clavulanique Zydus

Amoxicilline/Acide Clavulanique Zydus may be available in the countries listed below.

Ingredient matches for Amoxicilline/Acide Clavulanique Zydus

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilline/Acide Clavulanique Zydus in the following countries:

• France

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicilline/Acide Clavulanique Zydus in the following countries:

• France

International Drug Name Search

Terbane

Terbane may be available in the countries listed below.

Ingredient matches for Terbane

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbane in the following countries:

• South Africa

International Drug Name Search

Louten T

Louten T may be available in the countries listed below.

Ingredient matches for Louten T

Latanoprost

Latanoprost is reported as an ingredient of Louten T in the following countries:

• Peru

Timolol

Timolol maleate (a derivative of Timolol) is reported as an ingredient of Louten T in the following countries:

• Peru

International Drug Name Search

Clopidogrel hydrochlorid Hexal

Clopidogrel hydrochlorid Hexal may be available in the countries listed below.

Ingredient matches for Clopidogrel hydrochlorid Hexal

Clopidogrel

Clopidogrel hydrochloride (a derivative of Clopidogrel) is reported as an ingredient of Clopidogrel hydrochlorid Hexal in the following countries:

• Germany

International Drug Name Search

Aminophyllinum

Aminophyllinum may be available in the countries listed below.

Ingredient matches for Aminophyllinum

Aminophylline

Aminophylline is reported as an ingredient of Aminophyllinum in the following countries:

• Bosnia & Herzegowina


• Czech Republic


• Ethiopia


• Poland


• Serbia


• Slovenia

International Drug Name Search

Clinimycin

Clinimycin may be available in the countries listed below.

Ingredient matches for Clinimycin

Clindamycin

Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Clinimycin in the following countries:

• Bahrain

Oxytetracycline

Oxytetracycline dihydrate (a derivative of Oxytetracycline) is reported as an ingredient of Clinimycin in the following countries:

• Ireland

International Drug Name Search

Miracol

Miracol may be available in the countries listed below.

Ingredient matches for Miracol

Miconazole

Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Miracol in the following countries:

• Colombia

International Drug Name Search

Episindan

Episindan may be available in the countries listed below.

Ingredient matches for Episindan

Epirubicin

Epirubicin is reported as an ingredient of Episindan in the following countries:

• Georgia

Epirubicin hydrochloride (a derivative of Epirubicin) is reported as an ingredient of Episindan in the following countries:

• Bulgaria


• Romania

International Drug Name Search

Temol

Temol may be available in the countries listed below.

Ingredient matches for Temol

Paracetamol

Paracetamol is reported as an ingredient of Temol in the following countries:

• Vietnam

International Drug Name Search

AprilGen

AprilGen may be available in the countries listed below.

Ingredient matches for AprilGen

Quinapril

Quinapril is reported as an ingredient of AprilGen in the following countries:

• Poland

International Drug Name Search

Pirepine

Pirepine may be available in the countries listed below.

Ingredient matches for Pirepine

Pirenzepine

Pirenzepine dihydrochloride (a derivative of Pirenzepine) is reported as an ingredient of Pirepine in the following countries:

• Taiwan

International Drug Name Search

Primatene

In the US, Primatene (ephedrine/guaifenesin systemic) is a member of the drug class upper respiratory combinations and is used to treat Cold Symptoms.

US matches:

• Primatene Asthma


• Primatene Mist Aerosol


• Primatene

Ingredient matches for Primatene

Epinephrine

Epinephrine is reported as an ingredient of Primatene in the following countries:

• United States

International Drug Name Search

Clindamycin Billix

Clindamycin Billix may be available in the countries listed below.

Ingredient matches for Clindamycin Billix

Clindamycin

Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Clindamycin Billix in the following countries:

• Germany

International Drug Name Search

Levalbuterol Hydrochloride

Ingredient matches for Levalbuterol Hydrochloride

Levosalbutamol

Levalbuterol Hydrochloride (USAN) is also known as Levosalbutamol (Rec.INN)

International Drug Name Search

Glossary

Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Erymicin

Erymicin may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Erymicin

Erythromycin

Erythromycin is reported as an ingredient of Erymicin in the following countries:

• Australia

International Drug Name Search

Betasept

In the US, Betasept (chlorhexidine topical) is a member of the following drug classes: antiseptic and germicides, mouth and throat products and is used to treat Gingivitis, Mucositis and Periodontitis.

US matches:

• Betasept Liquid


• Betasept

Ingredient matches for Betasept

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Betasept in the following countries:

• United States

International Drug Name Search

Glufan

Glufan may be available in the countries listed below.

Ingredient matches for Glufan

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Glufan in the following countries:

• Malta

Glucosamine

Glucosamine hydrochloride (a derivative of Glucosamine) is reported as an ingredient of Glufan in the following countries:

• Spain

International Drug Name Search

Lucidex

In the US, Lucidex is a member of the drug class CNS stimulants and is used to treat Hypersomnia.

Ingredient matches for Lucidex

Memantine

Memantine hydrochloride (a derivative of Memantine) is reported as an ingredient of Lucidex in the following countries:

• Argentina

International Drug Name Search

Eposino

Eposino may be available in the countries listed below.

Ingredient matches for Eposino

Epoetin Alfa

Epoetin Alfa is reported as an ingredient of Eposino in the following countries:

• Philippines

International Drug Name Search

Lowette

Lowette may be available in the countries listed below.

Ingredient matches for Lowette

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Lowette in the following countries:

• Belgium

Levonorgestrel

Levonorgestrel is reported as an ingredient of Lowette in the following countries:

• Belgium

International Drug Name Search

Cristadoce

Cristadoce may be available in the countries listed below.

Ingredient matches for Cristadoce

Cyanocobalamin

Cyanocobalamin is reported as an ingredient of Cristadoce in the following countries:

• Venezuela

International Drug Name Search

Jiexin

Jiexin may be available in the countries listed below.

Ingredient matches for Jiexin

Pegfilgrastim

Pegfilgrastim is reported as an ingredient of Jiexin in the following countries:

• China

International Drug Name Search

Ciclétanine

Ciclétanine may be available in the countries listed below.

Ingredient matches for Ciclétanine

Cicletanine

Ciclétanine (DCF) is also known as Cicletanine (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Kwells

Kwells

300 microgram tablets

Hyoscine Hydrobromide

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Kwells 300 microgram tablets carefully to get the best results from them.

• Keep this leaflet. You may need to read it again.


• Ask your pharmacist if you need more information or advice.


• You must contact a doctor if your symptoms worsen or do not improve.


• If you have any unusual effects after taking this medicine, tell your doctor or pharmacist.

In This Leaflet:

• 1. What are Kwells tablets and what are they used for?


• 2. Before you take Kwells tablets


• 3. How to take Kwells tablets


• 4. Possible side effects


• 5. How to store Kwells tablets


• 6. Further information

What Are Kwells Tablets And What Are They Used For?

Kwells 300 microgram tablets are used for the fast and effective prevention and control of travel sickness. Travel sickness happens when the brain receives mixed messages. Visual messages from the eyes inform the brain that the immediate surroundings are stationary, but a delicate balancing organ in the ear tells the brain that you are moving. This conflicting information triggers the nausea we associate with travel sickness.

The active substance in Kwells tablets is hyoscine hydrobromide. Hyoscine hydrobromide temporarily reduces the effect of movement on the balance organs of the inner ear and the nerves responsible for nausea.

Because Kwells tablets melt in the mouth, absorption into the bloodstream is very rapid and they can be taken up to 20-30 minutes before travelling or at the onset of sickness.

Before You Take Kwells Tablets

DO NOT take Kwells tablets if you:

• Are allergic (hypersensitive) to hyoscine hydrobromide or any of the other ingredients in the tablets (see Section 6. Further Information).



• Have any of the following conditions:
  
  • Glaucoma.
  
  
  • Blockage of intestines (Paralytic ileus).
  
  
  • Narrowing of the stomach outlet (Pyloric stenosis).
  
  
  • Myasthenia gravis.
  
  
  • Enlarged prostate gland.
  
  

Before taking Kwells tablets, you should see your doctor if you:

• Are over 60 years of age.


• Are under medical care, especially for heart, metabolic, gastrointestinal, liver or kidney conditions.


• Have previously had a sudden painful inability to pass urine.


• Have ulcerative colitis.


• Have diarrhoea or fever.


• Have Down’s Syndrome.


• Suffer from seizures or fits.

Additional precautions for children:

This product should only be given to children over 10 years old.

Since it may cause drowsiness, children taking this medicine should not be left unattended.

Taking other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take Kwells tablets if you are taking any of the following medicines, unless advised by your doctor:

• Amantadine (an antiviral).


• Antihistamines.


• Antipsychotics.


• Antidepressants.


• Linezolid (and antibiotic).


• Domperidone and metoclopramide (for nausea and vomiting).


• Sublingual nitrates (for angina).

Taking Kwells tablets with food and drink:

Do not drink alcohol while taking Kwells tablets as this may make you feel more drowsy.

Driving and using machines:

May cause drowsiness. If affected do not drive or operate machinery.

Pregnancy and breast-feeding:

Do not take Kwells tablets if you are pregnant or breast-feeding unless recommended by your doctor or midwife.

How To Take Kwells Tablets

If Kwells tablets have been prescribed for you by your doctor, follow any instructions he/she may have given you. If you purchased this product without a prescription, follow these directions closely:

The tablets can be sucked, chewed or swallowed. They have a scoreline so they can be halved if necessary. The tablets can be taken up to 30 minutes before travelling to prevent travel sickness or at the onset of nausea.

Adults: Take one tablet every 6 hours, as required. Do not take this medicine more than 3 times in 24 hours.

Elderly: Consult your doctor or pharmacist before taking Kwells tablets.

Children over 10 years: Give your child half or one tablet every 6 hours, as required. Do not give your child this medicine more than 3 times in 24 hours.

Kwells tablets should not be given to children under 10 years of age.

If you take more Kwells tablets than recommended:

Symptoms of an overdose may include: fast or irregular heart-beat, difficulty passing water, blurred vision or dislike of bright light. Hallucinations may occur.

If you have any of these symptoms or have taken more than the recommended dose, tell your doctor or contact your nearest Accident and Emergency Department immediately.

How to help avoid travel sickness:

• Sit with the head tilted back to stabilise the balancing mechanism in the ear.


• Ensure the vehicle you are in is well ventilated.


• Try to have a clear view of the window.


• Have a bite to eat before the journey to help keep the stomach settled, but avoid greasy food.


• If you travel by car take regular breaks for exercise, fresh air and refreshments.


• In an aeroplane you can ease the pressure on your ears by sucking a boiled sweet during take off and landing.


• NEVER Read.


• Avoid strong smelling food, smoke, perfume, or petrol fumes.

Kwells Side Effects

Like all medicines, Kwells tablets can cause side effects, although not everybody gets them.

Some people have experienced blurred vision, dilated pupils, dry mouth, drowsiness and dizziness. You may also experience an increased body temperature due to decreased sweating.

Less frequently, there have been reports of restlessness, hallucinations and confusion.

If you are epileptic, you might suffer from increased seizure frequency.

As with all medicines, some people may be allergic to the tablets. If you are allergic, you may experience difficulty in breathing, coughing, wheezing or symptoms such as rash, itching and swelling.

If you experience any of these effects or react badly to the tablets in any other way, tell your doctor immediately.

How To Store Kwells Tablets

Keep out of the reach and sight of children.

Do not store above 25ºC. This product should be stored in the original carton.

Do not use the tablets after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Kwells tablets contain:

• The active substance is hyoscine hydrobromide at a strength of 300 micrograms.


• The other ingredients are mannitol (E421), potato starch, gelatine powder, aluminium stearate, saccharin sodium (E954) and ferric oxide (E172).

What Kwells tablets look like and contents of the pack:

Kwells tablets are small, circular, pink and flat with a single scoreline on the surface. The carton contains 12 tablets packaged inside a blister pack.

Marketing Authorisation Holder:

Bayer plc

Consumer Care Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

Manufacturer:

Pharmapac UK

Unit 20

Valley Road Business Park

Bidston

Wirral

CH41 7EL

United Kingdom

This leaflet was last approved in October 2007.

Remember: If you have any doubts about using Kwells tablets correctly, seek the advice of your doctor or pharmacist.

= Registered Trade Mark of Bayer AG, Germany.

Cordamil

Cordamil may be available in the countries listed below.

Ingredient matches for Cordamil

Verapamil

Verapamil hydrochloride (a derivative of Verapamil) is reported as an ingredient of Cordamil in the following countries:

• Romania

International Drug Name Search

Jodid Draselný Unimed Pharma

Jodid Draselný Unimed Pharma may be available in the countries listed below.

Ingredient matches for Jodid Draselný Unimed Pharma

Potassium Iodide

Potassium Iodide is reported as an ingredient of Jodid Draselný Unimed Pharma in the following countries:

• Czech Republic


• Slovakia

International Drug Name Search

Cetamol

Cetamol may be available in the countries listed below.

Ingredient matches for Cetamol

Paracetamol

Paracetamol is reported as an ingredient of Cetamol in the following countries:

• Oman


• Tunisia

International Drug Name Search

Etorac

Etorac may be available in the countries listed below.

Ingredient matches for Etorac

Ketorolac

Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Etorac in the following countries:

• Bangladesh

International Drug Name Search

Mofen

Mofen may be available in the countries listed below.

Ingredient matches for Mofen

Ibuprofen

Ibuprofen is reported as an ingredient of Mofen in the following countries:

• Indonesia


• Vietnam

International Drug Name Search

Hivent

Hivent may be available in the countries listed below.

Ingredient matches for Hivent

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Hivent in the following countries:

• Indonesia

International Drug Name Search

Agoxin

Agoxin may be available in the countries listed below.

Ingredient matches for Agoxin

Digoxin

Digoxin is reported as an ingredient of Agoxin in the following countries:

• Bangladesh

International Drug Name Search

Ledion

Ledion may be available in the countries listed below.

Ingredient matches for Ledion

Buspirone

Buspirone hydrochloride (a derivative of Buspirone) is reported as an ingredient of Ledion in the following countries:

• Greece

International Drug Name Search

Merom

Merom may be available in the countries listed below.

Ingredient matches for Merom

Meropenem

Meropenem is reported as an ingredient of Merom in the following countries:

• Bangladesh

International Drug Name Search

Irrodan

Irrodan may be available in the countries listed below.

Ingredient matches for Irrodan

Buflomedil

Buflomedil hydrochloride (a derivative of Buflomedil) is reported as an ingredient of Irrodan in the following countries:

• China


• Georgia


• Greece


• Hong Kong


• Italy

International Drug Name Search

Anabrest

Anabrest may be available in the countries listed below.

Ingredient matches for Anabrest

Anastrozole

Anastrozole is reported as an ingredient of Anabrest in the following countries:

• Hungary

International Drug Name Search

Flurbic

Flurbic may be available in the countries listed below.

Ingredient matches for Flurbic

Flurbiprofen

Flurbiprofen is reported as an ingredient of Flurbic in the following countries:

• Argentina

International Drug Name Search

Furovet

Furovet may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Furovet

Furosemide

Furosemide is reported as an ingredient of Furovet in the following countries:

• Finland

International Drug Name Search

Eujum

Eujum may be available in the countries listed below.

Ingredient matches for Eujum

Dinoprost

Dinoprost tromethamine (a derivative of Dinoprost) is reported as an ingredient of Eujum in the following countries:

• Taiwan

International Drug Name Search

Amiodarona MK

Amiodarona MK may be available in the countries listed below.

Ingredient matches for Amiodarona MK

Amiodarone

Amiodarone is reported as an ingredient of Amiodarona MK in the following countries:

• Colombia


• Ecuador

International Drug Name Search

Tobrin

Tobrin may be available in the countries listed below.

Ingredient matches for Tobrin

Tobramycin

Tobramycin is reported as an ingredient of Tobrin in the following countries:

• Bahrain


• Bulgaria


• Chile


• Egypt


• Georgia


• Iraq


• Jordan


• Kuwait


• Lebanon


• Libya


• Lithuania


• Oman


• Qatar


• Romania


• Saudi Arabia


• Sudan


• United Arab Emirates


• Yemen

International Drug Name Search

Enalapril comp. Heumann

Enalapril comp. Heumann may be available in the countries listed below.

Ingredient matches for Enalapril comp. Heumann

Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril comp. Heumann in the following countries:

• Germany

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Enalapril comp. Heumann in the following countries:

• Germany

International Drug Name Search

TX Oint

TX Oint may be available in the countries listed below.

Ingredient matches for TX Oint

Tetracycline

Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of TX Oint in the following countries:

• India

International Drug Name Search

Bersen MD

Bersen MD may be available in the countries listed below.

Ingredient matches for Bersen MD

Prednisone

Prednisone is reported as an ingredient of Bersen MD in the following countries:

• Chile

International Drug Name Search

Falicard

Falicard may be available in the countries listed below.

Ingredient matches for Falicard

Verapamil

Verapamil hydrochloride (a derivative of Verapamil) is reported as an ingredient of Falicard in the following countries:

• Germany


• Romania

International Drug Name Search

Eritromicina Larjan

Eritromicina Larjan may be available in the countries listed below.

Ingredient matches for Eritromicina Larjan

Erythromycin

Erythromycin ethylsuccinate (a derivative of Erythromycin) is reported as an ingredient of Eritromicina Larjan in the following countries:

• Argentina

International Drug Name Search

Glucotika

Glucotika may be available in the countries listed below.

Ingredient matches for Glucotika

Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Glucotika in the following countries:

• Indonesia

International Drug Name Search

Metagard

Metagard may be available in the countries listed below.

Ingredient matches for Metagard

Trimetazidine

Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Metagard in the following countries:

• Myanmar


• Singapore


• Vietnam

International Drug Name Search

Fluconazol MF

Fluconazol MF may be available in the countries listed below.

Ingredient matches for Fluconazol MF

Fluconazole

Fluconazole is reported as an ingredient of Fluconazol MF in the following countries:

• Peru

International Drug Name Search

Clindamicina Northia

Clindamicina Northia may be available in the countries listed below.

Ingredient matches for Clindamicina Northia

Clindamycin

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Clindamicina Northia in the following countries:

• Argentina

International Drug Name Search

Citrate de Piperazine

Citrate de Piperazine may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Citrate de Piperazine

Piperazine

Piperazine citrate (a derivative of Piperazine) is reported as an ingredient of Citrate de Piperazine in the following countries:

• France

International Drug Name Search

Memac Paranova

Memac Paranova may be available in the countries listed below.

Ingredient matches for Memac Paranova

Donepezil

Donepezil hydrochloride (a derivative of Donepezil) is reported as an ingredient of Memac Paranova in the following countries:

• Denmark

International Drug Name Search

Caluniatin S

Caluniatin S may be available in the countries listed below.

Ingredient matches for Caluniatin S

Kallidinogenase

Kallidinogenase is reported as an ingredient of Caluniatin S in the following countries:

• Japan


• Taiwan

International Drug Name Search

Penecort

In the US, Penecort is a member of the drug class topical steroids and is used to treat Anal Itching, Aphthous Stomatitis - Recurrent, Atopic Dermatitis, Dermatitis, Eczema, Gingivitis, Proctitis, Pruritus, Psoriasis, Seborrheic Dermatitis, Skin Rash and Ulcerative Colitis - Active.

Ingredient matches for Penecort

Hydrocortisone

Hydrocortisone is reported as an ingredient of Penecort in the following countries:

• United States

International Drug Name Search

Fluconazol Actavis

Fluconazol Actavis may be available in the countries listed below.

Ingredient matches for Fluconazol Actavis

Fluconazole

Fluconazole is reported as an ingredient of Fluconazol Actavis in the following countries:

• Estonia


• Switzerland

International Drug Name Search

Lactulose-Solvay

Lactulose-Solvay may be available in the countries listed below.

Ingredient matches for Lactulose-Solvay

Lactulose

Lactulose is reported as an ingredient of Lactulose-Solvay in the following countries:

• Austria


• Luxembourg

International Drug Name Search

First Mectin

First Mectin may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for First Mectin

Abamectin

Abamectin is reported as an ingredient of First Mectin in the following countries:

• Australia

Praziquantel

Praziquantel is reported as an ingredient of First Mectin in the following countries:

• Australia

International Drug Name Search

Rigotax

Rigotax may be available in the countries listed below.

Ingredient matches for Rigotax

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Rigotax in the following countries:

• Chile

International Drug Name Search

Tussal Expectorans

Tussal Expectorans may be available in the countries listed below.

Ingredient matches for Tussal Expectorans

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Tussal Expectorans in the following countries:

• Poland

International Drug Name Search

Latanoprost Gen

Latanoprost Gen may be available in the countries listed below.

Ingredient matches for Latanoprost Gen

Latanoprost

Latanoprost is reported as an ingredient of Latanoprost Gen in the following countries:

• Argentina

International Drug Name Search

Tilidin AbZ

Tilidin AbZ may be available in the countries listed below.

Ingredient matches for Tilidin AbZ

Naloxone

Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Tilidin AbZ in the following countries:

• Germany

Tilidine

Tilidine hydrochloride hemihydrate (a derivative of Tilidine) is reported as an ingredient of Tilidin AbZ in the following countries:

• Germany

International Drug Name Search

Clomifene Citrate

Clomifene Citrate may be available in the countries listed below.

Ingredient matches for Clomifene Citrate

Clomifene

Clomifene Citrate (BANM) is also known as Clomifene (Rec.INN)

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Eurimolan

Eurimolan may be available in the countries listed below.

Ingredient matches for Eurimolan

Brotizolam

Brotizolam is reported as an ingredient of Eurimolan in the following countries:

• Japan

International Drug Name Search

Astoprotin

Astoprotin may be available in the countries listed below.

Ingredient matches for Astoprotin

Procaterol

Procaterol hydrochloride hemihydrate (a derivative of Procaterol) is reported as an ingredient of Astoprotin in the following countries:

• Japan

International Drug Name Search

Inuvic

Inuvic may be available in the countries listed below.

Ingredient matches for Inuvic

Montelukast

Montelukast is reported as an ingredient of Inuvic in the following countries:

• Venezuela

International Drug Name Search

Paraqueimol

Paraqueimol may be available in the countries listed below.

Ingredient matches for Paraqueimol

Sulfacetamide Sodium

Sulfacetamide sodium salt (a derivative of Sulfacetamide) is reported as an ingredient of Paraqueimol in the following countries:

• Brazil

International Drug Name Search

Multiferrum

Multiferrum may be available in the countries listed below.

Ingredient matches for Multiferrum

Iron Dextran

Iron Dextran is reported as an ingredient of Multiferrum in the following countries:

• Greece

International Drug Name Search

Bitoxil

Bitoxil may be available in the countries listed below.

Ingredient matches for Bitoxil

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Bitoxil in the following countries:

• Bangladesh

International Drug Name Search

Aspirin Bayer

Ingredient matches for Aspirin Bayer

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Aspirin Bayer in the following countries:

• Indonesia


• Japan


• Singapore


• United States

International Drug Name Search

Feksofenadin

Feksofenadin may be available in the countries listed below.

Ingredient matches for Feksofenadin

Fexofenadine

Fexofenadine is reported as an ingredient of Feksofenadin in the following countries:

• Slovenia

International Drug Name Search

Insulin Actraphane HM

Insulin Actraphane HM may be available in the countries listed below.

Ingredient matches for Insulin Actraphane HM

Insulin Injection, Biphasic Isophane

Insulin Injection, Biphasic Isophane human (a derivative of Insulin Injection, Biphasic Isophane) is reported as an ingredient of Insulin Actraphane HM in the following countries:

• Greece

International Drug Name Search

Epi-Pevaryl

Epi-Pevaryl may be available in the countries listed below.

Ingredient matches for Epi-Pevaryl

Econazole

Econazole is reported as an ingredient of Epi-Pevaryl in the following countries:

• Germany

International Drug Name Search

Mifégyne

Mifégyne may be available in the countries listed below.

Ingredient matches for Mifégyne

Mifepristone

Mifepristone is reported as an ingredient of Mifégyne in the following countries:

• France


• Tunisia

International Drug Name Search

Fenytaren

Fenytaren may be available in the countries listed below.

Ingredient matches for Fenytaren

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Fenytaren in the following countries:

• Japan

International Drug Name Search

Piperacillin Ibisqus

Piperacillin Ibisqus may be available in the countries listed below.

Ingredient matches for Piperacillin Ibisqus

Piperacillin

Piperacillin sodium salt (a derivative of Piperacillin) is reported as an ingredient of Piperacillin Ibisqus in the following countries:

• Germany

International Drug Name Search

Mometasona Korhispana

Mometasona Korhispana may be available in the countries listed below.

Ingredient matches for Mometasona Korhispana

Mometasone

Mometasone 17-(2-furoate) (a derivative of Mometasone) is reported as an ingredient of Mometasona Korhispana in the following countries:

• Spain

International Drug Name Search

Codeinefosfaat A

Codeinefosfaat A may be available in the countries listed below.

Ingredient matches for Codeinefosfaat A

Codeine

Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Codeinefosfaat A in the following countries:

• Netherlands

International Drug Name Search

Losartan / Hydrochlorothiazide Arrow

Losartan/Hydrochlorothiazide Arrow may be available in the countries listed below.

Ingredient matches for Losartan/Hydrochlorothiazide Arrow

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Losartan/Hydrochlorothiazide Arrow in the following countries:

• France

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan/Hydrochlorothiazide Arrow in the following countries:

• France

International Drug Name Search

Tolperis

Tolperis may be available in the countries listed below.

Ingredient matches for Tolperis

Tolperisone

Tolperisone hydrochloride (a derivative of Tolperisone) is reported as an ingredient of Tolperis in the following countries:

• Poland

International Drug Name Search

Kétamine Virbac

Kétamine Virbac may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Kétamine Virbac

Ketamine

Ketamine hydrochloride (a derivative of Ketamine) is reported as an ingredient of Kétamine Virbac in the following countries:

• France

International Drug Name Search

May Cimetidine

May Cimetidine may be available in the countries listed below.

Ingredient matches for May Cimetidine

Cimetidine

Cimetidine is reported as an ingredient of May Cimetidine in the following countries:

• Philippines

International Drug Name Search

Chemists' Own Period Pain Tablets

Chemists' Own Period Pain Tablets may be available in the countries listed below.

Ingredient matches for Chemists' Own Period Pain Tablets

Naproxen

Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Chemists' Own Period Pain Tablets in the following countries:

• Australia

International Drug Name Search

Xamiol gel

Xamiol gel

calcipotriol/betamethasone

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

There is information on the following

• 1. What Xamiol is and what it is used for


• 2. Before you use Xamiol


• 3. How to use Xamiol


• 4. Possible side effects


• 5. How to store Xamiol


• 6. Further information

What Xamiol Is And What It Is Used For

Xamiol is used as topical treatment of scalp psoriasis. Psoriasis is caused by your skin cells being produced too quickly. This causes redness, scaling and thickness of your skin.

Xamiol contains calcipotriol and betamethasone.

Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation.

Before You Use Xamiol

Do not use Xamiol:

• If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of Xamiol


• If you have problems with calcium levels in your body (ask your doctor)


• If you have other types of psoriasis: these are guttate, erythrodermic, exfoliative and pustular (ask your doctor)


• If you have serious liver or kidney disease.

As Xamiol contains a strong steroid, do NOT use it on skin affected by:

• infections caused by viruses (e.g. cold sores or chicken pox)


• infections caused by a fungus (e.g. athlete’s foot or ringworm)


• infections caused by bacteria


• infections caused by parasites (e.g. scabies)


• tuberculosis (TB) or syphilis


• perioral dermatitis (red rash around the mouth)


• thin skin, easily damaged veins, stretch marks


• ichthyosis (dry skin with fish-like scales)


• acne (pimples)


• rosacea (severe flushing or redness of the skin on the face)


• ulcers or broken skin.

Take special care with Xamiol:

Before using this product, tell your doctor/nurse/pharmacist if:

• you are using other medicines that contain corticosteroids as you may get side effects


• you have used this medicine for a long time and plan to stop (as there is a risk your psoriasis will get worse or ‘flare up’ when steroids are stopped suddenly)


• you have diabetes mellitus (diabetes) as your blood sugar/glucose level may be affected by the steroid


• your skin becomes infected as you may need to stop your treatment.

Special precautions

• Avoid using more than 100 grams per week


• Avoid using under a bathing cap, bandages or dressings as it increases the absorption of the steroid


• Avoid use on large areas of damaged skin as it increases the absorption of the steroid


• Avoid use on your face as the face is very sensitive to steroids


• Avoid excessive sunbathing, excessive use of solarium and other forms of light treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use Xamiol if you are pregnant (or might be pregnant) or if you are breast-feeding, unless you have agreed it with your doctor first.

Driving and using machines

This medicine should not have any effect on your ability to drive or use machinery.

Important information about some of the ingredients of Xamiol

Xamiol contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

How To Use Xamiol

Always use Xamiol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to put on Xamiol: Cutaneous use. Medicine only to be used on scalp.

Xamiol is not recommended for the use in children and adolescents below the age of 18 years.

Instructions for proper use

• Use only on your psoriasis on the scalp and do not use on skin which does not have psoriasis


• Shake the bottle before use and remove the cap


• Apply Xamiol to the areas of your scalp affected by psoriasis. Comb the hair first to remove any loose scales. Tilt your head to make sure Xamiol does not run onto your face. It may help to part your hair before you use Xamiol.
  Apply Xamiol to the affected area with your fingertips, and rub it in gently


• Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon)


• Do not bandage, tightly cover or wrap the treated skin area


• Wash your hands well after using Xamiol. This will avoid accidentally spreading the gel to other parts of your body (especially the face, mouth and eyes)


• Do not worry if some gel accidentally gets on normal skin near your psoriasis, but wipe it off if it spreads too far


• After applying the gel, avoid contact with textiles which are easily stained by grease (e.g. silk).

Washing your hair before application of Xamiol is not necessary.

1. It may help to part your hair before you use Xamiol.

2. Apply Xamiol to the areas of your scalp affected by psoriasis.

3. Gently rub in Xamiol using your fingertips.

In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application of Xamiol. Let Xamiol remain on the scalp during the night or during the day. When washing hair after application the following instructions might be useful:

4. Apply a mild shampoo to the dry hair, especially to those areas where the gel was applied.

5. Leave the shampoo on the scalp for a couple of minutes before washing.

6. Wash your hair as usual.

If necessary, repeat steps 4-6 once or twice.

Duration of treatment

• Use the gel once a day. It may be more convenient to use the gel in the evening



• The normal initial treatment period is 4 weeks



• Your doctor may decide on a different treatment period



• Your doctor may decide on repeated treatment.

• Do not use
  
  
  • more than 15 grams in one day or
  
  
  
  • 100 grams in one week.
  
  

All the affected scalp areas may be treated with Xamiol. However, if you also use calcipotriol containing products on your body psoriasis, then the total amount of calcipotriol products must not exceed 15 grams per day or 100 grams per week and the area treated should not exceed 30% of the total body surface.

What should I expect when I use Xamiol?

Most patients see obvious results after 2 weeks, even if the psoriasis is not yet cleared at that point.

If you have used more Xamiol than you should

Contact your doctor if you have used more than 15 grams in one day or 100 grams in one week. Excessive prolonged use of Xamiol may cause a problem with calcium in your blood, which usually normalises when discontinuing treatment.

Your doctor may need to carry out blood tests to check that using too much gel has not caused a problem with calcium in your blood.

Excessive prolonged use can also cause your adrenal glands to stop working properly (the adrenal glands are found near the kidneys and produce hormones).

If you forget to use Xamiol

Do not use a double dose to make up for forgotten individual doses.

If you stop using Xamiol

The use of Xamiol should be stopped as indicated by your doctor. It may be necessary for you to stop this medicine gradually, especially if you have used it for a long time.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

Xamiol gel Side Effects

Like all medicines, Xamiol can cause side effects, although not everybody gets them.

Approximately 1 in 12 people may experience side effects, but most of these are reactions at the site where the gel has been applied.

Serious side effects:

Tell your doctor/nurse immediately or as soon as possible if any of the following happens. You may have to stop your treatment:

Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients in Xamiol. You should tell your doctor as soon as possible if any of the serious side effects occur. These side effects occur rarely but are more likely to happen after long-term use, or use under occlusion. The side effects include the following:

• Your adrenal glands may stop working properly. Signs are tiredness, depression and anxiety



• Cataracts (signs are cloudy and foggy vision, difficulty seeing at night and sensitivity to light) or an increase in pressure inside your eye (signs are eye pain, red eye, decreased or cloudy vision)



• Infections (because your immune system, which fights infections, may be suppressed or weakened)



• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If you notice this, stop taking Xamiol and tell your doctor as soon as possible.

Uncommon (affect less than 1 in 100 people):

• Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible.

Very rare (affect less than 1 in 10,000 people):

• Allergic reactions with deep swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and trouble breathing may occur. If you have an allergic reaction, stop taking Xamiol, tell your doctor immediately or go to the casualty department at your nearest hospital



• Treatment with this gel may cause the level of calcium in your blood or urine to increase (usually when too much gel has been used). Signs of increased calcium in blood are bone pain, constipation, poor appetite, nausea and vomiting. This can be serious, and you should contact your doctor immediately. However, when the treatment is stopped, the levels return to normal.

Less serious side effects caused by using betamethasone for a long time include the following, and you should tell your doctor or nurse as soon as possible if you notice any of them:

• Thinning of the skin



• Appearance of surface veins or stretch marks



• Changes in hair growth



• Red rash around the mouth (perioral dermatitis)



• Skin rash with inflammation or swelling (allergic contact dermatitis)



• Small white spots (colloid milia)



• Depigmentation (lightening of skin colour).

The following less serious side effects have also been reported for Xamiol:

Common side effects (affect less than 1 in 10 people):

• Itching.

Uncommon (affect less than 1 in 100 people):

• Eye irritation



• Burning sensation of the skin



• Skin pain or irritation



• Inflammation or swelling of the hair root (folliculitis)



• Rash with inflammation of the skin (dermatitis)



• Redness of the skin due to widening of the small blood vessels (erythema)



• Acne (pimples)



• Dry skin



• Rash



• Pustular rash.

Do not stop Xamiol unless your doctor tells you to, as it may be necessary for you to stop this medicine gradually.

If you notice the above or any other changes in your health while taking this medicine, tell your doctor.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Xamiol

• Keep out of the reach and sight of children



• Do not use Xamiol after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month



• Do not refrigerate. Keep the bottle in the outer carton in order to protect from light



• Discard the bottle with any remaining gel 3 months after first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Xamiol contains

The active substances are:

Calcipotriol and betamethasone.

One gram of gel contains 50 microgram of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

The other ingredients are:

• paraffin, liquid



• polyoxypropylene-15 stearyl ether



• castor oil, hydrogenated



• butylhydroxytoluene (E321)



• all-rac-α-tocopherol

What Xamiol looks like and the contents of the pack

Xamiol is an almost clear, colourless to slightly off-white gel in high-density polyethylene bottles with a low-density polyethylene nozzle and a high-density polyethylene screw cap.

The bottles are placed in cartons.

Pack sizes: 15, 30, 60 and 2 x 60 g.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is:

LEO Pharmaceutical Products Ltd. A/S

DK-2750 Ballerup

Denmark

The manufacturer is:

LEO Pharmaceutical Products Ltd. A/S

DK-2750 Ballerup

Denmark

For further information about this product, contact the local representative of the Marketing Authorisation Holder:

LEO Laboratories Limited

Princes Risborough

Bucks

HP27 9RR

U.K.

Tel:(01844) 347333

e-mail:medical-info.uk@leo-pharma.com

This medicinal product is authorised in the Member States of the EEA under the following names:

Xamiol gel: UK

This leaflet was last approved in: 09/2008

Registered Trade Mark

LEO

023946-00

Flutinax

Flutinax may be available in the countries listed below.

Ingredient matches for Flutinax

Fluoxetine

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Flutinax in the following countries:

• Mexico

International Drug Name Search

Lansoprazol Farmoz

Lansoprazol Farmoz may be available in the countries listed below.

Ingredient matches for Lansoprazol Farmoz

Lansoprazole

Lansoprazole is reported as an ingredient of Lansoprazol Farmoz in the following countries:

• Portugal

International Drug Name Search

Acelisino comp

Acelisino comp. may be available in the countries listed below.

Ingredient matches for Acelisino comp.

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Acelisino comp. in the following countries:

• Austria

Lisinopril

Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Acelisino comp. in the following countries:

• Austria

International Drug Name Search

Potassium Bromide

In some countries, this medicine may only be approved for veterinary use.

Scheme

USAN

CAS registry number (Chemical Abstracts Service)

0007758-02-3

Chemical Formula

K-Br

Molecular Weight

119

Therapeutic Category

Antiepileptic agent

Foreign Names

• Kalii bromidum (Latin)
• Kaliumbromid (German)
• Potassium (Bromure de) (French)

Generic Names

• Potassium Bromide (OS: JAN)
• Kalii bromidum (PH: Ph. Eur. 5)
• Kaliumbromid (PH: Ph. Eur. 5)
• Potassium (bromure de) (PH: Ph. Eur. 5)
• Potassium Bromide (PH: BP 2010, USP 32, Ph. Eur. 5)

Brand Names

• Bromapex (veterinary use)
  Apex Laboratories, Australia



• DIBRO-BE mono
  Dibropharm, Germany



• Epibrom (veterinary use)
  Hi-Perform Veterinary Products, Australia



• Epilease (veterinary use)
  Vet Plus, United Kingdom



• KBr Tablets (veterinary use)
  Genitirix, United Kingdom

International Drug Name Search

Glossary

JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Rabies Vaccine BP (Sanofi Pasteur MSD Limited)

1. Name Of The Medicinal Product

Rabies Vaccine BP

2. Qualitative And Quantitative Composition

After reconstitution, 1 dose (1ml) contains:

Rabies virus* (inactivated, strain PM/WI 38 1503-3M)……..

*produced in human diploid MRC-5 cells

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Powder and solvent for suspension for injection

The powder is pinkish beige to orangey yellow.

The solvent is a clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

For prophylactic immunisation against rabies. Treatment of patients following suspected rabies contact.

4.2 Posology And Method Of Administration

Administer by intramuscular injection. The vaccine should be administered into the deltoid region. For instructions on the reconstitution of the vaccine before administration, see section 6.6.

Adults, Elderly and Children

Prophylaxis:

Three injections each of 1 millilitre given on days 0, 7 and 28. A single reinforcing dose should be given at two or three year intervals to those at continued risk.

If, for whatever reason, it has not been possible to give a full course of three injections, it is probable that, in the majority of subjects, two doses may be adequate to confer protection, provided these were given four weeks apart. Subjects receiving only two injections who remain at continued risk should receive a reinforcing dose 6-12 months later, with further reinforcing doses given at two to three year intervals.

Treatment

(i) In persons known to have adequate prophylaxis:

In the event of contact with a suspected rabid animal, two further boosters should be given on day 0 and on day 3 to 7.

(II) In persons with no, or possibly inadequate, prophylaxis:

The first injection of rabies vaccine should be given as soon as possible after the suspected contact (day 0) and followed by five further doses on days 3, 7, 14, 30 and 90. The use of Human Rabies Immunoglobulin on day 0 should be considered, but only in persons with no adequate prophylaxis. The treatment schedule may be stopped if the animal concerned is found conclusively to be free of rabies.

4.3 Contraindications

Pre Exposure

Known systemic hypersensitivity reaction to any component of Rabies Vaccine BP or after previous administration of the vaccine or a vaccine containing the same components as Rabies Vaccine BP.

Vaccination must be postponed in case of febrile and/or acute disease.

Post Exposure

Since declared rabies infection generally results in death, there are no contraindications to post exposure vaccination.

4.4 Special Warnings And Precautions For Use

In subjects with a history of allergy there may be an increased risk of side-effects and this possibility should be taken into account.

As with all vaccines, appropriate facilities and medication such as epinephrine (adrenaline) should be readily available for immediate use in case of anaphylaxis or hypersensitivity following injection.

The vaccine may contain traces of neomycin and betapropiolactone which are used during the manufacturing process. Caution must be exercised when the vaccine is administered to subjects with hypersensitivity to betapropiolactone, neomycin, and other antibiotics of the same class

Rabies Vaccine BP should not be administered to patients with bleeding disorders such as haemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefit clearly outweighs the risk of administration. If the decision is taken to administer Rabies Vaccine BP in such persons, it should be given with caution with steps taken to avoid the risk of haematoma formation following injection.

The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Corticosteroids and immunosuppressive treatments may interfere with antibody production and cause the failure of the vaccination. It is therefore advisable to perform a neutralising antibody assay 2 – 4 weeks after the last injection.

Administration of an additional dose should be considered if the antibody titre is less than 0.5 IU/ml (using an RFFIT analysis – Rapid Fluorescent Focus Inhibition Test).

4.6 Pregnancy And Lactation

Data on limited number of exposed pregnancies do not allow a conclusion on the potential risk of Rabies HDCV for pregnancy or for the health of the foetus/newborn child. Due to the severity of disease, pregnancy is not considered a contraindication to post exposure prophylaxis. If there is substantial risk of exposure to rabies, pre-exposure prophylaxis may also be indicated during pregnancy.

Due to the severity of the disease, breast feeding is not considered a contraindication and treatment must not be discontinued. It is not known whether this vaccine is excreted in human breast milk, thus no recommendation on continuation/discontinuation of breastfeeding can be made.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects reported.

4.8 Undesirable Effects

Adverse reaction information is derived from clinical trials and worldwide post- marketing experience.

Two randomised controlled trials where Rabies Vaccine BP has been studied in both children (n=199) using pre-exposure schedule (3 doses, IM) and adults (n=124) using the post exposure schedule (5 doses, IM) have been selected to represent safety clinical data.

Within each system organ class the adverse reactions are ranked under headings of frequency, using the following convention:

Very common (>1/10)

Common (>1/100, <1/10)

Uncommon (>1/1000, <1/100)

Not known (cannot be estimated from the available data because only reported post marketing and not in clinical trials)

The most frequent adverse reactions are injection site pain and headache.

•Blood and lymphatic system disorders
	o Very common: lymphadenopathy
•Immune system disorders
	o Common: allergic reactions with skin disorders such as urticaria, rash and pruritus, or respiratory manifestations such as dyspnoea and wheezing. Angioedema.
	o Not known: anaphylactic and serum sickness type reactions, oedema

These reactions have been associated with the presence of betapropiolactone-altered human albumin (including the production of IgE antibodies in the vaccine).

Allergic reactions occurred more frequently among persons receiving booster than primary vaccination. Further information on allergic reactions see section 4.4.

• Nervous system disorders
	o Very common: headache o Common: dizziness o Not known: encephalitis, convulsion, Guillain-Barré Syndrome, paresis, neuropathy, paraesthesia
• Gastrointestinal disorders
	o Very common: nausea, diarrhoea o Common: abdominal pain, vomiting
• Musculoskeletal and connective tissue disorders
	o Very common: myalgia, arthralgia
• General disorders and administration site conditions
	o Very common: injection site reactions including pain, erythema, induration and injection site pruritus. Malaise, chills o Common: injection site bruising, pyrexia o Not known: asthenia

Additional information on special populations:

Apnoea in very premature infants (

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The vaccine is a lyophilised, stabilised suspension of inactivated Wistar rabies virus strain PM/WI 38-1503-3M, cultured in human diploid cells (MRC₅) and inactivated by beta-propiolactone.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Human albumin solution.

Solvent: Water for Injections (1 millilitre).

6.2 Incompatibilities

In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.

6.3 Shelf Life

3 years

Once reconstituted, the vaccine must be used immediately.

6.4 Special Precautions For Storage

Store between +2°C and +8°C in a refrigerator. Do not freeze.

6.5 Nature And Contents Of Container

Powder:

Single dose (Ph Eur type 1 glass) vial with elastomeric stopper (chlorobutyl) and aluminium overcap.

Solvent:

1.0 ml disposable syringe (type I glass) with a plunger-stopper (elastomer) with attached needle and needle-guard (elastomer).

1.0 ml disposable syringe (type 1 glass) with a plunger-stopper (chlorobromobutyl) without needle and with a tip- cap (chlorobromobutyl). Up to two separate needles (for each syringe) may be included in the pack.

1.0 ml disposable syringe (type I glass) with a plunger-stopper (elastomer) with attached needle and needle shield (grey elastomer).

Pack of 1 vial and 1 prefilled syringe.

Not all pack presentations may be marketed.

6.6 Special Precautions For Disposal And Other Handling

For needle free syringes, the needle should be pushed firmly on to the end of the prefilled syringe and rotated through 90 degrees.

Reconstitute the freeze-dried vaccine by introducing the solvent provided in the pre-filled syringe into the vial of powder. Shake carefully until complete suspension of the powder is obtained. Following reconstitution, the suspension will be a pinkish colour and free from particles. Withdraw the suspension from the vial into the syringe prior to intramuscular injection.

Shake well immediately before use.

Use immediately after reconstitution.

Any unused product or waste material should be disposed of, in accordance with local requirements.

7. Marketing Authorisation Holder

Sanofi Pasteur MSD Limited

Mallards Reach

Bridge Avenue

Maidenhead

Berkshire

SL6 1QP

8. Marketing Authorisation Number(S)

PL 6745/0053

9. Date Of First Authorisation/Renewal Of The Authorisation

7 November 1994

10. Date Of Revision Of The Text

07/2010