País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Hepatitis B vaccine, rDNA 40 µg/mL
Merck Sharp & Dohme (New Zealand) Limited
Hepatitis B vaccine, rDNA 40 µg/mL
40 mcg/mL
Suspension for injection
Active: Hepatitis B vaccine, rDNA 40 µg/mL Excipient: Aluminium as amorphous aluminum hydroxyphosphate sulphate Borax Formaldehyde Potassium thiocyanate Sodium chloride Water for injection
Vial, glass, single dose, 1 mL
Prescription
Prescription
Merck Sharp & Dohme Corp
Immunisation against infection caused by all known subtypes of hepatitis B virus. HBvaxPRO should also prevent hepatitis D (caused by the delta virus) since hepatitis D does not occur in the absence of hepatitis B infection.
Package - Contents - Shelf Life: Vial, glass, single dose, 1.0ml - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1970-01-01
HBVAXPRO ® _hepatitis B Vaccine (Recombinant) _ 5 mcg hepatitis B surface antigen per 0.5 mL (without preservative) 10 mcg hepatitis B surface antigen per 1.0 mL (without preservative) 40 mcg hepatitis B surface antigen per 1.0 mL (This formulation is intended for predialysis/dialysis patients only (without preservative)) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about HBvaxPRO. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of you being given HBvaxPRO against the benefits they expect it will have for you. If you have any concerns about being given this vaccine, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again. WHAT HBVAXPRO IS USED FOR HBvaxPRO is a vaccine used to help prevent hepatitis B. The vaccine can be given to newborns, infants, children, teenagers and adults. Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). It can be caught by coming into contact with an infected person’s blood, semen, vaginal secretions, saliva or other body fluids. For example, if these infected fluids enter your blood stream through a cut in your skin, you could become infected. Other situations that could lead to infection include: • being born to a mother who carries the HBV • sexual contact with someone who is infected • living in the same house as someone who is infected • close family contact, for example, sharing razors or toothbrushes • having a job that involves exposure to human blood or body fluids, for example, some health care workers • sharing needles for injecting drugs • travelling to areas where hepatitis B is common People who have hepatitis B may not look or feel sick when infected. In fact, a person could be infected by the virus six weeks to six months before symptoms occur. Some people develop mild, flu-like symptoms. Others may become very ill and extremely tired, deve Leia o documento completo
Page 1 of 13 NEW ZEALAND DATA SHEET 1 PRODUCT NAME HBvaxPRO® 5 mcg/0.5 mL Suspension for injection HBvaxPRO® 10 mcg/mL Suspension for injection HBvaxPRO® 40 mcg/mL Suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _Hepatitis B vaccine (recombinant) injections _ 5 mcg hepatitis B surface antigen per 0.5 mL (without preservative) 10 mcg hepatitis B surface antigen per 1.0 mL (without preservative) 40 mcg hepatitis B surface antigen per 1.0 mL (This formulation is intended for predialysis/dialysis patients only (without preservative)) The vaccine is available in 0.5 mL vials containing 5 mcg of hepatitis B surface antigen and in 1.0 mL vials containing 10 mcg of hepatitis B surface antigen*. The vaccine is also produced as a 1.0 mL vial containing 40 mcg of hepatitis B surface antigen* for use in dialysis and predialysis patients. * produced in _Saccharomyces cerevisiae_ (strain 2150-2-3) yeast by recombinant DNA technology. Each 0.5 mL dose contains approximately 0.25 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate adjuvant, and 35 mcg of sodium borate, 4.5 mg sodium chloride, and water for injection. Each 1 mL dose contains approximately 0.5 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate adjuvant, and 70 mcg of sodium borate, 9.0 mg sodium chloride, and water for injection. The 5 mcg/0.5 mL, the 10 mcg/1.0 mL and the 40 mcg/1.0 mL formulations are only available without preservative. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminium (provided as amorphous aluminium hydroxyphosphate sulphate adjuvant) per mL of vaccine. The vaccine is of the _adw_ subtype. This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Suspension for injection Slightly opaque white suspension 4 CLINICAL PARTICULARS IPC-V232-I-052018 Page 2 of 13 4.1 THERAPEUTIC IND Leia o documento completo