Engerix-B

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Hepatitis B surface antigen, recombinant 20 µg/mL; Hepatitis B surface antigen, recombinant 20 µg/mL

Beszerezhető a:

GlaxoSmithKline NZ Limited

INN (nemzetközi neve):

Hepatitis B surface antigen, recombinant 20 mg/mL

Adagolás:

10 mcg/0.5mL

Gyógyszerészeti forma:

Suspension for injection

Összetétel:

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

db csomag:

Syringe, Paediatric dose, 0.5 mL

Osztály:

Prescription

Recept típusa:

Prescription

Gyártó:

GlaxoSmithKline Biologicals SA

Terápiás javallatok:

ENGERIX-B is indicated for active immunization against hepatitis B virus infection.

Termék összefoglaló:

Package - Contents - Shelf Life: Syringe, Paediatric dose - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Paediatric dose - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Engedély dátuma:

1988-03-24

Betegtájékoztató

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

Termékjellemzők

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