Țară: Noua Zeelandă
Limbă: engleză
Sursă: Medsafe (Medicines Safety Authority)
Hepatitis A vaccine 1440 EU/mL equivalent to 720 EU/0.5 mL; ; Hepatitis A vaccine 1440 EU/mL equivalent to 720 EU/0.5mL
GlaxoSmithKline NZ Limited
Hepatitis A vaccine 1440 EU/mL (= 720 EU/0.5 mL)
720 ELISA U/0.5mL
Suspension for injection
Active: Hepatitis A vaccine 1440 EU/mL equivalent to 720 EU/0.5 mL Excipient: Aluminium hydroxide Amino acids Dibasic sodium phosphate dihydrate Monobasic potassium phosphate Polysorbate 20 Potassium chloride Sodium chloride Active: Hepatitis A vaccine 1440 EU/mL equivalent to 720 EU/0.5mL Excipient: Aluminium hydroxide Amino acids Dibasic sodium phosphate dihydrate Monobasic potassium phosphate Phenoxyethanol Polysorbate 20 Potassium chloride Sodium chloride
Syringe, glass, prefilled syringe, 0.5 mL
Prescription
Prescription
GlaxoSmithKline Biologicals SA
HAVRIX is indicated for active immunisation against HAV infection in subjects at risk of exposure to HAV. HAVRIX will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low and intermediate prevalence of hepatitis A, immunisation with HAVRIX is particularly recommended in subjects who are, or will be, at increased risk of infection.
Package - Contents - Shelf Life: Syringe, glass, prefilled syringe - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 days not refrigerated stored at or below 25°C - Vial, glass, Monodose, Type 1 glass. - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 days not refrigerated stored at or below 25°C
1995-11-27
1 HAVRIX ® 1440 AND HAVRIX ® JUNIOR Inactivated Hepatitis A Virus Vaccine CONSUMER MEDICINE INFORMATION LEAFLET_ _ In this leaflet, HAVRIX refers to the use of both HAVRIX 1440 for adults and HAVRIX Junior for children. WHAT IS IN THIS LEAFLET? This leaflet answers some of the common questions about HAVRIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of you or your child having HAVRIX against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT HAVRIX TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE . You may need to read it again. WHAT IS HAVRIX USED FOR HAVRIX is a vaccine used to prevent hepatitis A infection. The vaccine works by causing the body to produce its own protection (antibodies) against this disease. Hepatitis A is an infectious disease, which can affect the liver. This disease is caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever and aches and pains. After a few days the whites of eyes and skin may become yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe enough to keep people off work for about a month. Hepatitis A is very common in many parts of the world, and the risk of infection is greatest in those areas where hygiene and sanitation are poor. Such areas include Asia, India, Africa, Central and South America, the Pacific Islands, the Middle East, and the Mediterranean basin. HAVRIX is recommended for all travellers to these areas, including people in the armed forces. Hepatitis A occurs in New Zealand, but is not common. Some gr Citiți documentul complet
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME HAVRIX 1440: 1440 EU/mL inactivated hepatitis A virus (HM 175 hepatitis A virus strain) vaccine, suspension for injection. HAVRIX JUNIOR: 720 EU/0.5 mL inactivated hepatitis A virus (HM 175 hepatitis A virus strain) vaccine, suspension for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1.0 mL) of HAVRIX 1440 contains: Hepatitis A virus (inactivated) 1,2 1440 ELISA Units 1 Produced on human diploid (MRC-5) cells 2 Adsorbed on aluminium hydroxide, hydrated Total: 0.50 milligrams Al 3+ One dose (0.5 mL) of HAVRIX JUNIOR contains: Hepatitis A virus (inactivated) 1,2 720 ELISA Units 1 Produced on human diploid (MRC-5) cells 2 Adsorbed on aluminium hydroxide, hydrated Total: 0.25 milligrams Al 3+ For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Suspension for injection. Turbid liquid suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be observed. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HAVRIX is indicated for active immunisation against HAV infection in subjects at risk of exposure to HAV. HAVRIX will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low and intermediate prevalence of hepatitis A, immunisation with HAVRIX is particularly recommended in subjects who are, or will be, at increased risk of infection, such as: 2 TRAVELLERS: Persons travelling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America. ARMED FORCES: Armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of HAV infection. Active immunisation is indicated for these individuals. PERSONS FOR WHOM HEPATITIS A IS AN OCCUPATIONAL HAZARD OR FOR WHOM THERE IS AN INCREASED RISK OF TRANSMISSION: These include employees in Citiți documentul complet