Država: Malta
Jezik: angleščina
Source: Medicines Authority
VARICELLA VIRUS, OKA, MERCK STRAIN, LIVE, ATTENUATED
Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem Noord-Holland, 2031 BN, Netherlands
J07BK01
VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
POM
VACCINES
Authorised
2005-10-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VARIVAX POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE VARICELLA VACCINE (LIVE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS VACCINATED BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor or your pharmacist. − This vaccine has been prescribed for you or your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET: 1. What VARIVAX is and what it is used for 2. What you need to know before you or your child receives VARIVAX 3. How VARIVAX is given 4. Possible side effects 5. How to store VARIVAX 6. Contents of the pack and other information 1. WHAT VARIVAX IS AND WHAT IT IS USED FOR VARIVAX is a vaccine to help protect adults and children against chickenpox (varicella). Vaccines are used to protect you or your child against infectious diseases. VARIVAX can be administered to persons 12 months of age or older. VARIVAX may also be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations. It may also be given to persons who have no history of chickenpox, but who have been exposed to someone who has chickenpox. Vaccination within 3 days of exposure may help prevent chickenpox or reduce the severity of disease, resulting in fewer skin lesions and shorter duration of illness. In addition, there is limited information that being vaccinated up to 5 days after exposure may reduce disease severity. As with other vaccines, VARIVAX does not completely protect all individuals from naturally acquired chickenpox. 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVES VARIVAX DO NOT USE VARIVAX IF: − you or y Preberite celoten dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 16 1. NAME OF THE MEDICINAL PRODUCT VARIVAX powder and solvent for suspension for injection in a pre-filled syringe Varicella Vaccine (live) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 mL) contains: Varicella virus * Oka/Merck strain (live, attenuated) ≥1350 PFU** * Produced in human diploid cells (MRC-5) ** PFU = Plaque-forming units This vaccine may contain a trace amount of neomycin (see sections 4.3 and 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection. White to off-white powder and clear, colourless liquid solvent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VARIVAX is indicated for vaccination against varicella in individuals from 12 months of age (see sections 4.2 and 5.1). VARIVAX can be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations (see sections 4.2, 4.5, and 5.1). VARIVAX may also be administered to susceptible individuals who have been exposed to varicella. Vaccination within 3 days of exposure may prevent a clinically apparent infection or modify the course of the infection. In addition, there are limited data that indicate that vaccination up to 5 days after exposure may modify the course of the infection (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ The use of VARIVAX should be based on official recommendations. Individuals less than 9 months of age VARIVAX should not be administered to individuals less than 9 months of age. Individuals from 9 months of age Individuals should receive two doses of VARIVAX to ensure optimal protection against varicella (see section 5.1). Page 3 of 16 • Individuals from 9 to 12 months of age In settings in which vaccination is initiated between 9 and 12 months of age, a second dose is needed and should be given after a minimum interval of 3 months (see section 5.1). Preberite celoten dokument