Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Hepatitis A vaccine 50 U/mL
Merck Sharp & Dohme (New Zealand) Limited
Hepatitis A vaccine 50 U/mL
50 U/mL
Suspension for injection
Active: Hepatitis A vaccine 50 U/mL Excipient: Aluminium as amorphous aluminium hydroxyphosphate sulphate Borax Sodium chloride Water for injection
Syringe, (not marketed), 0.5 mL
Prescription
Prescription
Merck Sharp & Dohme Corp
VAQTA is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus. Primary immunisation should be given at least 2 weeks prior to expected exposure to HAV. Vaccination is recommended in children 12 months of age and older, adolescents, and adults who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected, including but not limited to: · travellers to endemic or outbreak areas · frequently affected communities - members residing in any community with one or more recorded outbreaks within the last five years · daycare - children and staff of daycare centres as well as their parents, siblings, and other contacts · military personnel prior to departure for endemic or outbreak areas · persons for whom hepatitis A is an occupational hazard - health-care workers - staff and residents of orphanages, chronic care hospitals and mental health care facilities - sewage workers · haemophiliacs and other recipients of therapeutic blood products · persons who test positive for hepatitis C virus and have diagnosed liver disease · food handlers · consumers of high-risk foods e.g. raw shellfish · persons at increased risk of the disease due to their sexual practices - homosexually-active males - persons who repeatedly contract sexually transmitted diseases · human immunodeficiency virus (HIV)-infected adults · users of illicit injectable drugs VAQTA will not prevent hepatitis caused by infectious agents other than hepatitis A virus.
Package - Contents - Shelf Life: Syringe, - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1995-03-30
New Zealand Consumer Medicine Information VAQTA ® _Hepatitis A Vaccine, purified, inactivated _ Single dose vial WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VAQTA. 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 VAQTA against the benefits they expect it will have for you. If you have any concerns about being given this vaccine, ask your doctor. Keep this leaflet. You may need to read it again. WHAT VAQTA IS USED FOR VAQTA is a vaccine used to help prevent hepatitis A. It can be given to children 12 months of age and older, teenagers and adults. Hepatitis A is an infection of the liver caused by the hepatitis A virus. It can be caught by coming into contact with an infected person who has poor sanitary habits, eating or drinking foods prepared by an infected food handler, or, while uncommon, by blood transfusion from an infected donor. Other circumstances that can increase the risk of infection include: • travelling to areas where hepatitis A is common • living in a community with one or more recorded outbreaks within the last five years • being around groups of other children, for example, daycare centres • working with the intellectually disabled • sewerage workers • living in the same house as someone who is infected • having chronic liver disease or having had a liver transplant • sexual contact with someone who is infected • being infected with Human Immunodeficiency Virus (HIV) • working in the healthcare field • sharing needles for injecting drugs • having a blood disorder requiring transfusion of blood products • having a positive test for hepatitis C virus and have a diagnosis of liver disease Symptoms of hepatitis A usually begin 2 to 8 weeks after coming into c Preberite celoten dokument
NEW ZEALAND DATA SHEET NAME OF MEDICINE VAQTA ® _Hepatitis A Vaccine, purified, inactivated _ Single dose 0.5 mL and 1.0 mL vials for intramuscular injection PRESENTATION A slightly opaque white sterile suspension after thorough agitation. The vaccine is available in paediatric/adolescent 0.5 mL and adult 1.0 mL vials containing 25U and 50U of hepatitis A virus protein respectively. Each 0.5 mL dose contains approximately 0.225 mg of aluminium provided as amorphous aluminium hydroxyphosphate sulfate and 35 mcg of sodium borate as a pH stabiliser, in 0.9% sodium chloride. Each 1.0 mL dose contains approximately 0.45 mg of aluminium provided as amorphous aluminium hydroxyphosphate sulfate and 70 mcg of sodium borate as a pH stabiliser in 0.9% sodium chloride. THERAPEUTIC CLASS VAQTA is an inactivated whole virus vaccine which has been shown to induce antibody to hepatitis A virus protein. USES ACTIONS Hepatitis A Disease Hepatitis A virus is one of several hepatitis viruses that cause a systemic infection with pathology in the liver. The incubation period ranges from approximately 20 to 50 days. While the course of the disease is generally benign and does not result in chronic hepatitis, infection with hepatitis A virus remains an important cause of morbidity and occasional fulminant hepatitis and death. Hepatitis A is transmitted most often by the faecal-oral route, with infection occurring within private households, daycare centres, neonatal intensive care units, and chronic-care hospitals. Common-source outbreaks due to contaminated food and water supplies have occurred following consumption of certain foods such as raw shellfish, and uncooked foods prepared by an infected food-handler or otherwise contaminated prior to ingestion (salads, sandwiches, frozen raspberries, etc.). Bloodborne transmission, while uncommon, is possible via blood transfusion, contaminated blood products, or from needles shared Preberite celoten dokument