Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Hepatitis B surface antigen, recombinant 20 µg/mL; Hepatitis B surface antigen, recombinant 20 µg/mL
GlaxoSmithKline NZ Limited
Hepatitis B surface antigen, recombinant 20 µg/mL
20 mcg/mL
Suspension for injection
Active: Hepatitis B surface antigen, recombinant 20 µg/mL Excipient: Aluminium hydroxide Dibasic sodium phosphate dihydrate Monobasic sodium phosphate dihydrate Phenoxyethanol Sodium chloride Thiomersal Water for injection Active: Hepatitis B surface antigen, recombinant 20 µg/mL Excipient: Aluminium hydroxide Dibasic sodium phosphate dihydrate Monobasic sodium phosphate dihydrate Sodium chloride Water for injection
Syringe, Prefilled. 1.0 mL, 1 dose unit
Prescription
Prescription
GlaxoSmithKline Biologicals SA
ENGERIX-B is indicated for active immunization against hepatitis B virus infection.
Package - Contents - Shelf Life: Syringe, Prefilled. 1.0 mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, Prefilled. 1.0 mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 1.0mL (Adult dose) - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 1.0mL (Adult dose) - 3 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1988-03-24
1 ENGERIX-B Recombinant DNA hepatitis B vaccine CONSUMER MEDICINE INFORMATION LEAFLET_ _ WHAT IS IN THIS LEAFLET? This leaflet answers some of the common questions about ENGERIX-B 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 ENGERIX-B against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT ENGERIX-B TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE . You may need to read it again. WHAT IS ENGERIX-B USED FOR ENGERIX-B is a vaccine used to prevent hepatitis B infection. The vaccine works by aiding the body to produce its own protection (antibodies) against this disease. Hepatitis B is an infectious disease, which can affect the liver. This disease is caused by the hepatitis B virus. The hepatitis B virus is found in body fluids such as blood, semen, vaginal secretions or saliva of infected people. You can catch the virus if it enters your bloodstream. Ways this can happen are through: • injection (eg needlestick injury, or sharing needles for IV drug use) • sexual intercourse • sores, cuts or tiny wounds coming into contact with infected fluids (eg from a human bite, sharing razors or toothbrushes, or working with human blood or body fluids) • an infected mother passing the virus onto her baby during or shortly after birth. Some people infected with hepatitis B may not look or feel sick yet others will get symptoms. Symptoms may not appear for 6 weeks to 6 months after infection. Sometimes people will only have mild flu-like symptoms, but other people can become very ill. They may be extremely tired, and have dark urine, pale faeces, yellowish skin and/or eyes (jaundice), and may need to be admitted to hospital. There is a risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer for all chronic hepatitis B carriers. Some groups of people a Đọc toàn bộ tài liệu
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ENGERIX-B 20 micrograms/mL, suspension for injection. ENGERIX-B paediatric 10 micrograms/0.5 mL, suspension for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ENGERIX-B paediatric dose: 10 microgram (µg) dose vaccine 1 dose (0.5 mL) contains: Hepatitis B surface antigen 1, 2 10 micrograms 1 Adsorbed on aluminium hydroxide, hydrated Total: 0.25 milligrams Al 3+ 2 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology ENGERIX-B: 20 microgram (µg) dose vaccine 1 dose (1 mL) contains: Hepatitis B surface antigen 1, 2 20 micrograms 1 Adsorbed on aluminium hydroxide, hydrated Total: 0.50 milligrams Al 3+ 2 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology The vaccine is highly purified, and meets the WHO requirements for recombinant hepatitis B vaccines. No substances of human origin are used in its manufacture. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Suspension for injection. ENGERIX-B is a turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant may be observed. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications ENGERIX-B is indicated for active immunisation against hepatitis B virus infection. As part of the national immunisation schedule, the New Zealand Ministry of Health* recommend all infants, unvaccinated children up to the age of 16 years, and household and sexual contacts of known hepatitis B carriers receive a primary course of vaccination against hepatitis B. 2 Immunisation is also recommended for seronegative persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis B virus (HBV). Groups identified at increased risk of acquiring HBV infection include: Infants born to carrier (HBsAg-positive) mothers Infants (born to HBsAg-negative mothers) and young children (under 10 years) in communities with a hepatitis B carrier rate over 2% including indigenous peo Đọc toàn bộ tài liệu