Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Hepatitis A vaccine 1440 EU/mL (virus antigen (HM175 strain)); Vi capsular polysaccharide of S. typhi ty2 25 µg/mL;
GlaxoSmithKline NZ Limited
Hepatitis A vaccine 1440 EU/mL (virus antigen (HM175 strain))
Suspension for injection
Active: Hepatitis A vaccine 1440 EU/mL (virus antigen (HM175 strain)) Vi capsular polysaccharide of S. typhi ty2 25 µg/mL Excipient: Aluminium hydroxide Amino acids Formaldehyde Neomycin sulfate Polysorbate 20 Sodium chloride Trometamol Water for injection
Syringe, glass, pre-filled, 1 mL
Prescription
Prescription
GlaxoSmithKline Biologicals SA
HEPATYRIX is indicated for active immunisation of adults and adolescents older than 15 years of age at risk of both hepatitis A virus infection and typhoid fever. Immunisation with HEPATYRIX is particularly recommended in subjects who are, or will be, at increased risk of infection such as travellers from countries of low endemicity to areas where the prevalence of hepatitis A and typhoid fever is high.
Package - Contents - Shelf Life: Syringe, glass, pre-filled - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, pre-filled, 1mL - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, - 3 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 3mL pack - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2002-02-21
1 HEPATYRIX ® (COMBINED INACTIVATED HEPATITIS A AND VI POLYSACCHARIDE TYPHOID VACCINE) CONSUMER MEDICINE INFORMATION LEAFLET WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about HEPATYRIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of you or your child having HEPATYRIX against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING HEPATYRIX TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT HEPATYRIX IS USED FOR HEPATYRIX is a combination vaccine used to prevent hepatitis A and typhoid fever. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. Hepatitis A is an infectious disease caused by a virus, which causes the liver to be become inflamed (swollen). Typhoid fever is an infectious disease caused by a bacteria called _Salmonella typhi._ _Hepatitis A _ Symptoms of hepatitis A usually begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever, aches and pains. After a few days the skin and/or the whites of the eyes may beome yellowish (jaundice). The severity and type of symptoms can vary. Hepatitis A is often milder in young children. Most people recover completely but the illness is usually severe enough to keep adults off work for about a month. _Typhoid Fever _ Symptoms of typhoid fever can begin at varying times after coming into contact with the bacteria. These consist of headache, pains in the stomach, constipation or diarrhoea and a fever that may last for one or two weeks. Patients normally get better after about four weeks, but relapses can occur. The hepatitis A virus and _Salmonella typhi _bacteria can both be passed from person to person in food and drink, or by swimming in water contaminated by sewage. These diseases are very Lesen Sie das vollständige Dokument
1 DATA SHEET NAME OF MEDICINAL PRODUCT HEPATYRIX _Inactivated hepatitis A and purified Vi polysaccharide typhoid vaccine _ PRESENTATION HEPATYRIX is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A virus (HM175 hepatitis A virus strain) adsorbed onto aluminium hydroxide and the Vi capsular polysaccharide extracted from _ Salmonella _ _typhi_ Ty2 strain. HEPATYRIX meets the WHO requirements for manufacture of biological substances and complies with the European Pharmacopoeia monograph for Vi polysaccharide typhoid vaccines and the European Pharmacopoeia monograph for Hepatitis A vaccine (inactivated, adsorbed). Each 1 ml dose of vaccine contains 25 µg of the Vi polysaccharide of _Salmonella typhi_ and not less than 1440 ELISA Units (EL.U.) of inactivated hepatitis A viral antigen. _THERAPEUTIC INDICATIONS _ HEPATYRIX is indicated for active immunisation of adults and adolescents older than 15 years of age at risk of both hepatitis A virus infection and typhoid fever. Immunisation with HEPATYRIX is particularly recommended in subjects who are, or will be, at increased risk of infection such as travellers from countries of low endemicity to areas where the prevalence of hepatitis A and typhoid fever is high. _POSOLOGY AND METHOD OF ADMINISTRATION _ The vaccine is a ready-to-use suspension. It must be shaken well before use, since upon storage, the vaccine settles down as a fine white deposit with a clear colourless supernatant. After shaking the vaccine is a slightly opaque, white suspension. Discard if the contents appear otherwise. All parenteral compounds and vaccine products should be inspected visually prior to administration for discolouration or particulate matter. DOSAGE A dose of 1.0 ml is recommended for adults and adolescents older than 15 years of age. A single dose of HEPATYRIX is used for primary immunisation. For travellers, this dose should be given at least 2 weeks prior to departure. 2 _BOOSTER DOSE _ The anti-HAV and anti-Vi a Lesen Sie das vollständige Dokument