Страна: Швеция
Език: шведски
Източник: Läkemedelsverket (Medical Products Agency)
hepatit A-virus, inaktiverat antigen
Sanofi Pasteur Europe
J07BC02
hepatitis A virus, inactivated antigen
Injektionsvätska, suspension, förfylld spruta
formaldehyd Hjälpämne; aluminiumoxid, hydratiserad Adjuvans; hepatit A-virus, inaktiverat antigen 80 E Aktiv substans; etanol, vattenfri Hjälpämne
Receptbelagt
Förpacknings: Förfylld spruta, 10 st (utan nålar); Förfylld spruta, 1 st (utan nålar); Förfylld spruta med fastsatt nål, 10 st; Förfylld spruta med fastsatt nål, 1 st; Förfylld spruta, 1 st ( med två nålar); Förfylld spruta, 10 st ( med 20 st nålar)
Godkänd
2021-01-26
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER AVAXIM JUNIOR, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Hepatitis A vaccine (inactivated, adsorbed) 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, pharmacist or nurse. • This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them. • If you or your child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What AVAXIM Junior is and what it is used for 2. What you need to know before you use AVAXIM Junior 3. How to use AVAXIM Junior 4. Possible side effects 5. How to store AVAXIM Junior 6. Contents of the pack and other information 1. WHAT AVAXIM JUNIOR IS AND WHAT IT IS USED FOR WHAT AVAXIM JUNIOR IS Avaxim Junior is a vaccine. Vaccines are used to protect against infectious diseases. WHAT AVAXIM JUNIOR IS USED FOR This vaccine helps to protect against hepatitis A infection. • It is used in children aged from 1 year up and including 15 years of age. Hepatitis A infection is caused by a virus that attacks the liver. • It may be caught from food or drink that contains the virus. • Symptoms include yellowing of the skin and eyes (jaundice) and feeling generally unwell. HOW AVAXIM JUNIOR WORKS • When an injection of Avaxim Junior is given, the body’s natural defenses produce protection (antibodies) against hepatitis A infection. • This vaccine protects against hepatitis A - but it cannot cause a hepatitis A infection. • This vaccine will not protect against other viruses that attack the liver (such as hepatitis B, hepatitis C or hepatitis E viruses). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AVAXIM JUNIOR DO NOT USE AVAXIM JUNIOR IF YOU OR YOUR CHILD HAVE: • an allergy to the activ Прочетете целия документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT AVAXIM Junior, suspension for injection in pre-filled syringe. Hepatitis A vaccine (inactivated, adsorbed). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.5 millilitre dose contains: Hepatitis A virus, GBM strain (inactivated) 1, 2 ……80EU 3 1 produced in human diploid (MRC-5) cells 2 adsorbed on aluminium hydroxide, hydrated (0.15 milligrams Al 3+ ) 3 ELISA Unit. In the absence of an international standardised reference, the antigen content is expressed using an in- house reference Residues of clinical relevance The vaccine may contain traces of neomycin, which is used during the manufacturing process (see section 4.3). Excipient(s) with known effect (see Section 4.4): Phenylalanine………………10 micrograms For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. Hepatitis A vaccine (inactivated, adsorbed) is a cloudy and whitish suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against infection caused by hepatitis A virus in children from 1 year up and including 15 years of age. The use of Avaxim Junior should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The primary vaccination consists of one 0.5 ml dose of vaccine. Initial protection starts within 2 weeks after administration. In order to provide a long-term protection, a second dose (booster) of vaccine is recommended. This booster dose should be given between 6 months to 10 years after the first dose (see section 5.1).In line with WHO recommendation, in a setting transitioning from high to intermediate endemicity, in childhood immunization programmes either a single-dose or two-dose schedule (primary vaccination and booster) can be used. 3 This vaccine can be used as a booster in subjects previously vaccinated with another inactivated hepatitis A vaccine. Method of administration Avaxim Junior should Прочетете целия документ