Hiberix

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (20-40mcg of tetanus toxoid per dose)

Disponible depuis:

GlaxoSmithKline NZ Limited

DCI (Dénomination commune internationale):

Sodium chloride

Dosage:

0.5 mL

forme pharmaceutique:

Powder for injection with diluent

Composition:

Excipient: Sodium chloride Water for injection Active: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (20-40mcg of tetanus toxoid per dose) Excipient: Lactose Water for injection

Unités en paquet:

Combination pack, pdr. for susp.vials, prefilled diluent syringes, 20 needles, 10 dose units

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Catalent Belgium SA

indications thérapeutiques:

Hiberix is indicated for active immunisation of all infants from the age of 6 weeks against disease caused by Hib. Hiberix does not protect against diseases due to other types of H. influenzae, nor against meningitis caused by other organisms.

Descriptif du produit:

Package - Contents - Shelf Life: Combination pack, 1 x vial, 1 x syringe (supplied without needles) - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 1 x vial, 1 x syringe, 2 needles - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 10 x vials, 10 x syringes (supplied without needles) - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 10 x vials, 10 x syringes, 20 needles - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 1 x 0.5 mL diluent - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, vaccine powder for suspension - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Date de l'autorisation:

1999-11-02

Notice patient

HIBERIX
1
HIBERIX
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I RECEIVING HIBERIX?
HIBERIX is used to prevent Haemophilus influenzae type b (Hib)
infection in the first 6 months of life and can start from the age of
six weeks. HIBERIX contains a non-infectious extract from Haemophilus
influenzae type b bacteria bound to tetanus toxoid as the
active ingredient.
For more information, see Section 1. Why am I receiving HIBERIX? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I RECEIVE HIBERIX?
Do not use if your child has ever had an allergic reaction to HIBERIX,
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOUR CHILD HAS ANY OTHER MEDICAL CONDITIONS OR
TAKE ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I
receive HIBERIX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with HIBERIX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS HIBERIX GIVEN?
Your doctor or nurse will give you HIBERIX as an injection (dose of
0.5 mL). The primary vaccination schedule consists of three
doses in the first 6 months of life and can start from the age of six
weeks. A booster dose is recommended at 12 months of age to
ensure long term protection.
HIBERIX is injected into the upper leg muscle (infants under 12 months
of age) or injected into the upper arm muscle (children
over 12 months of age).For some children with bleeding problems, the
dose may need to be given under the skin
(subcutaneously).
More instructions can be found in Section 4. How is HIBERIX given? in
the full CMI.
5.
WHAT SHOULD I KNOW AFTER RECEIVING HIBERIX?
THINGS YOU
SHOULD DO

Keep a record of your immunisation history.
LOOKING AFTER
YOUR MEDICINE

HIBERIX will normally be stored at the doctor’s surgery or in the
pharmacy.

If you n

Résumé des caractéristiques du produit

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
HIBERIX Haemophilus influenzae type b (Hib) powder and diluent for
solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION_ _
After reconstitution, 1 dose (0.5 mL) contains:
_Haemophilus influenzae_ type b polysaccharide
10 micrograms
conjugated to tetanus toxoid as carrier protein
approximately 25 micrograms
For the full list of excipients, see section 6.1 List of excipients._
_
3.
PHARMACEUTICAL FORM
HIBERIX is a lyophilised vaccine, presented as a powder and diluent
for solution for injection.
The lyophilised vaccine is presented as a white powder in a glass
vial, and the sterile diluent
(saline) is presented as a clear and colourless liquid in a pre-filled
syringe.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
HIBERIX is indicated for active immunisation of all infants from the
age of 6 weeks against
disease caused by Hib.
HIBERIX does not protect against diseases due to other types of _H.
influenzae,_ nor against
meningitis caused by other organisms.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The primary vaccination schedule consists of three doses in the first
6 months of life and can
start from the age of six weeks. To ensure a long-term protection, a
booster dose is
recommended in the second year of life.
Infants between the ages of 6 and 12 months previously unvaccinated
should receive 2
injections, given with an interval of one month, followed by a booster
in the second year of life.
Previously unvaccinated children aged 1-5 years should be given one
dose of vaccine.
Method of administration
2
The reconstituted vaccine is for intramuscular injection. However, it
is good clinical practice that
in patients with thrombocytopenia or bleeding disorders the vaccine
should be administered
subcutaneously.
For instructions on reconstitution of the medicine before
administration, see section 6.6 Special
precautions for disposal and other handling.
4.3
CONTRAINDICATIONS
_ _
HIBERIX should not be administered to subjects with known
hypersensitivity t