Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Hepatitis A vaccine 720 EU/mL; ; Hepatitis B surface antigen, recombinant 20 µg/mL; Hepatitis A vaccine 720 EU/mL; Hepatitis B surface antigen, recombinant 20 µg/mL
GlaxoSmithKline NZ Limited
Hepatitis A vaccine 720 EU/mL
Suspension for injection
Active: Hepatitis A vaccine 720 EU/mL Hepatitis B surface antigen, recombinant 20 µg/mL Excipient: Aluminium Amino acids Formaldehyde Neomycin sulfate Phenoxyethanol Polysorbate 20 Sodium chloride Water for injection Active: Hepatitis A vaccine 720 EU/mL Hepatitis B surface antigen, recombinant 20 µg/mL Excipient: Aluminium Amino acids Dibasic sodium phosphate monohydrate Formaldehyde Monobasic sodium phosphate dihydrate Neomycin sulfate Polysorbate 20 Sodium chloride Trometamol Water for injection
Syringe, 1 mL
Prescription
Prescription
GlaxoSmithKline Biologicals SA
TWINRIX is indicated for active immunisation against hepatitis A and hepatitis B virus infection in adults. TWINRIX is also indicated for active immunisation against hepatitis A and hepatitis B virus infection in infants, children and adolescents from 1 year up to and including 15 years of age at risk of, or who wish to be protected against, both infections.
Package - Contents - Shelf Life: Syringe, - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1996-10-14
1 TWINRIX ® ADULT AND TWINRIX ® JUNIOR Inactivated hepatitis A and recombinant DNA hepatitis B vaccine CONSUMER MEDICINE INFORMATION In this leaflet, TWINRIX refers to both TWINRIX ADULT and TWINRIX JUNIOR. WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about TWINRIX 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 TWINRIX against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING TWINRIX TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. WHAT TWINRIX IS USED FOR TWINRIX is a combination vaccine used to prevent hepatitis A and hepatitis B infection. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. Hepatitis A and hepatitis B are infectious diseases, which cause the liver to be become inflamed (swollen). These diseases are caused by viruses - hepatitis A and hepatitis B viruses. 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 become 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. The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. 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. Areas include Asia, India, Africa, Central and South America, the Pacific Islands, the Middle East, and the Mediterranean Basin. Vaccination is recommended for travellers to these areas, including people in the armed forces. Some gro Prečítajte si celý dokument
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME TWINRIX: inactivated hepatitis A vaccine 720 EU/mL and recombinant DNA hepatitis B surface antigen, 20 µg/mL, suspension for injection TWINRIX JUNIOR: inactivated hepatitis A vaccine 720 EU/mL and recombinant DNA hepatitis B surface antigen, 20 µg/mL, suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TWINRIX and TWINRIX JUNIOR are combined vaccines formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate. The HA virus is propagated in MRC5 human diploid cells. HBsAg is produced by culture, in a selective medium, of genetically engineered yeast cells. A 1.0 mL dose of TWINRIX contains not less than 720 ELISA units of inactivated HA virus, and 20 g of recombinant HBsAg protein. A 0.5 mL dose of TWINRIX JUNIOR contains not less than 360 ELISA units of inactivated HA virus, and 10 g of recombinant HBsAg protein. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Suspension for injection. When re-suspended, the vaccine will have a uniform hazy white appearance. Upon storage, a fine white deposit with a clear colourless layer above may be observed. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TWINRIX is indicated for active immunisation against hepatitis A and hepatitis B virus infection in adults. TWINRIX is indicated in, but not limited to, the following groups of susceptible subjects at risk of acquiring hepatitis A and hepatitis B virus infection: • Healthcare personnel • Patients frequently receiving blood products • Personnel and residents of institutions • Persons at increased risk due to their sexual behaviour 2 • Illicit users of addictive injectable drugs • Travellers to areas of high HAV and HBV endemicity • Persons originating from areas of high HAV and HBV endemicity • Organ transplant candidates • Armed forces personnel Prečítajte si celý dokument