HIBERIX haemophilus influenzae type B conjugate 10microgram/0.5mL injection vial and diluent syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Tetanus toxoid, Quantity: 40 microgram/mL; Haemophilus influenza type B polyribose ribitol phosphate, Quantity: 20 microgram/mL

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Haemophilus influenza type B polyribose ribitol phosphate,Tetanus toxoid

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: water for injections; sodium chloride; lactose

Administration route:

Intramuscular

Units in package:

(Model 10520PS) plus associated needle AUSTL 19009, 1 vial + 1 diluent syringe, (Model 20510B), b) Becton - Dickinson without attached needle, 10 vials + 10 diluent syringes, a) Becton - Dickinson fitted with needle

Prescription type:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Therapeutic indications:

Hiberix is indicated for active immunisation against Haemophilus influenzae type b infection in children aged from 2 months to 5 years.

Product summary:

Visual Identification: White pellet; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1997-10-28

Patient Information leaflet

HIBERIX
®
1
HIBERIX
®
_Haemophilus influenzae type b (Hib) vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some of the
common questions about HIBERIX
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 your
child having HIBERIX against the
expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD RECEIVING HIBERIX TALK
TO YOUR DOCTOR, NURSE OR
PHARMACIST.
Keep this leaflet with this vaccine.
You may need to read it again.
WHAT IS HIBERIX USED
FOR?
HIBERIX is a non-infectious vaccine
used to prevent Haemophilus
influenzae type b (Hib) infection in
children aged 2 months to 5 years.
The vaccine works by causing the
body to produce its own protection
(antibodies) against the disease.
Haemophilus influenzae type b is a
bacteria that can cause serious life-
threatening illness. Hib infection
most frequently causes brain
inflammation (swelling), which is
generally seen in infants under 18
months of age. The death rate is 5-
10% of infants in this age group. In
15-30% of surviving infants there
will be some type of serious
complication such as: mental
retardation, cerebral palsy, deafness,
epilepsy or partial blindness. Hib
infection also causes inflammation of
the throat, which is mostly seen in
children over 18 months of age. It
occasionally causes death by
suffocation. Less commonly, the
bacteria can also infect the blood,
heart, lungs, bones, joints, and tissues
of the eyes and mouth.
Vaccination is the best way to protect
against Hib infection. HIBERIX
vaccine is not infectious, and cannot
give your child Hib infection. The
vaccine will not protect against
diseases caused by other types of
bacteria or organisms.
BEFORE VACCINATION
_HIBERIX SHOULD NOT BE _
_GIVEN IF: _

your child has had an allergic
reaction to HIBERIX, or any
ingredient contained in this
vaccine. The ingredients are
listed a

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
HIBERIX (HAEMOPHILUS INFLUENZAE TYPE B (HIB) VACCINE) POWDER AND
DILUENT FOR SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
_Haemophilus influenzae_ type b (Hib) vaccine.
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
HIBERIX is a non-infectious vaccine containing purified
polyribosyl-ribitol-phosphate
capsular polysaccharide (PRP) of Haemophilus influenzae type b
covalently bound to
tetanus toxoid.
HIBERIX is supplied as a white lyophilised powder for reconstitution
with a diluent (sterile
0.9% saline solution). The diluent is supplied as a clear and
colourless liquid.
The manufacture of this product includes exposure to bovine derived
materials. No
evidence exists that any case of vCJD (considered to be the human form
of bovine
spongiform encephalopathy) has resulted from the administration of any
vaccine product.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and diluent for solution for injection.
HIBERIX is presented as a white lyophilised powder in a glass vial.
The sterile 0.9% saline
diluent is clear and colourless and presented in a pre-filled
syringe._ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HIBERIX is indicated for active immunisation against _Haemophilus
influenzae_ type b infection
in children aged from 2 months to 5 years.
4.2
DOSE AND METHOD OF ADMINISTRATION
HIBERIX is supplied as a white lyophilised powder for reconstitution
with sterile 0.9% saline
diluent. HIBERIX is prepared as detailed below (see Section 4.2 DOSE
AND METHOD OF
ADMINISTRATION, Directions for Reconstitution).
2
The recommended dose is 0.5 mL.
HIBERIX vaccine must be administered by intramuscular injection. In
infants and children
under 12 months of age it is preferable to inject the vaccine in the
anterolateral thigh
beca