Vaqta Vaccine

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Hepatitis A vaccine 50 U/mL

Mevcut itibaren:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Adı):

Hepatitis A vaccine 50 U/mL

Doz:

50 U/mL

Farmasötik formu:

Suspension for injection

Kompozisyon:

Active: Hepatitis A vaccine 50 U/mL Excipient: Aluminium as amorphous aluminium hydroxyphosphate sulphate Borax Sodium chloride Water for injection

Paketteki üniteler:

Syringe, (not marketed), 0.5 mL

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Merck Sharp & Dohme Corp

Terapötik endikasyonlar:

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.

Ürün özeti:

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)

Yetkilendirme tarihi:

1995-03-30

Bilgilendirme broşürü

 
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

Ürün özellikleri

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