HBvaxPRO vaccine

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Hepatitis B vaccine, rDNA 10 µg/mL

Disponível em:

Merck Sharp & Dohme (New Zealand) Limited

DCI (Denominação Comum Internacional):

Hepatitis B vaccine, rDNA 10 µg/mL

Dosagem:

10 mcg/mL

Forma farmacêutica:

Suspension for injection

Composição:

Active: Hepatitis B vaccine, rDNA 10 µg/mL Excipient: Aluminium as amorphous aluminum hydroxyphosphate sulphate Borax Formaldehyde Potassium thiocyanate Sodium chloride Water for injection

Unidades em pacote:

Vial, glass, single dose, adolescent dose, 0.5 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Merck Sharp & Dohme Corp

Indicações terapêuticas:

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.

Resumo do produto:

Package - Contents - Shelf Life: Vial, glass, single dose, adolescent dose 0.5mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, adult 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 - Vial, glass, single dose, adolescent dose 0.5mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Data de autorização:

1987-10-15

Folheto informativo - Bula

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

Características técnicas

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