Act-HIB vaccine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Haemophilus influenzae type b vaccine 10ug (conjugated to tetanus protein (18-30µg))

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Haemophilus influenzae type b vaccine 10 µg (conjugated to tetanus protein (18-30µg))

Dosage:

10 mcg/0.5mL

Pharmaceutical form:

Injection with diluent

Composition:

Active: Haemophilus influenzae type b vaccine 10ug (conjugated to tetanus protein (18-30µg)) Excipient: Hydrochloric acid Sucrose Trometamol Sodium chloride Water for injection

Units in package:

Combination pack, 1 x ( vial + syringe ), 10 �g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Pasteur SA

Therapeutic indications:

Act-HIB is indicated for use in infants from 2 months to 5 years of age for active immunisation against invasive disease caused by the Haemophilus influenzae type b.

Product summary:

Package - Contents - Shelf Life: Combination pack, 1 x ( vial + syringe ) + 2 needles - 10 ?g - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, - 0.5 mL -   - Vial, glass, - 10 ?g -  

Authorization date:

1992-09-14

Patient Information leaflet

Act-HIB
®
1
ACT-HIB®
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 IS MY CHILD BEING GIVEN ACT-HIB?
Act-HIB is a vaccine that contains the active ingredient Haemophilus
type b polysaccharide conjugated to tetanus protein. It is
used to protect your child against Haemophilus Influenzae type b
infections.
For more information, see Section 1. Why is my child being given
Act-HIB? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE MY CHILD IS GIVEN ACT-HIB?
Do not use if your child has ever had an allergic reaction to Act-HIB,
formaldehyde or any of the ingredients listed at the end of
the CMI.
TALK TO YOUR DOCTOR IF YOUR CHILD HAS OR HAS HAD ANY OTHER MEDICAL
CONDITIONS OR IS TAKING OTHER MEDICINES.
For more information, see Section 2. What should I know before my
child is given Act-HIB? in the full CMI.
3.
WHAT IF MY CHILD AM TAKING OTHER MEDICINES?
Some medicines may interfere with Act-HIB and affect how it works.
A list of these medicines is in Section 3. What if my child is taking
other medicines? in the full CMI.
4.
HOW ACT-HIB IS GIVEN
•
Act-HIB is given by a doctor or nurse as an injection into muscle
More instructions can be found in Section 4. How Act-HIB is given in
the full CMI.
5.
WHAT SHOULD I KNOW AFTER MY CHILD IS GIVEN ACT-HIB?
THINGS YOU
SHOULD DO
•
Keep an updated record of your vaccinations.
•
Keep follow-up appointments with your doctor or clinic.
LOOKING AFTER
YOUR MEDICINE
•
Act-HIB is usually stored in the doctor’s surgery or clinic, or at
the pharmacy.
•
Store in a refrigerator (2°C - 8°C). Do not freeze.
For more information, see Section 5. What should I know after my child
is given Act-HIB? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects include local reaction around the injection site
(pain, redness, swelling, inflammation, hardening of the
skin), fever, irritability, vomiting, crying (uncontrollable or
abnormal), unusual tired

Summary of Product characteristics

acthib-ccdsv10-dsv6-20jun22
Page 1 of 8
NEW ZEALAND DATA SHEET
1
ACT-HIB (10 MCG/ 0.5 ML INJECTION WITH DILUENT)
Act-HIB
_ Haemophilus_
type b Conjugate Vaccine (conjugated to tetanus protein).
_Haemophilus_
type b polysaccharide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Act-HIB contains the capsular polysaccharide of the
_Haemophilus influenzae_
type b bacterial
strain conjugated to tetanus protein. The polysaccharide consists of
polyribosyl ribitol
phosphate (PRP).
ACTIVE INGREDIENTS:
_Haemophilus _
type b polysaccharide (10 micrograms) conjugated to tetanus protein
(18-30
micrograms).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Act-HIB is a freeze-dried powder for reconstitution with diluent for
injection. Following
reconstitution, the solution is limpid and colourless.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Act-HIB is indicated for use in infants from 2 months to 5 years of
age for active
immunisation against invasive disease caused by the
_Haemophilus influenzae_
type b.
The vaccine does not protect against infections due to other types of
_Haemophilus influenzae_
nor against meningitis from other causes.
NOTE: Under no circumstances should the tetanus protein component of
this vaccine be
substituted for the routine tetanus vaccination.
4.2
DOSE AND METHOD OF ADMINISTRATION
After reconstitution, the vaccine should be administered via the
intramuscular or
subcutaneous route.
The anterolateral thigh is the preferred site for vaccination in
infants and children under 12
months of age and the deltoid region is the preferred site for
vaccination in older children.
_ _
acthib-ccdsv10-dsv6-20jun22
Page 2 of 8
Vaccine injections should not be given in the dorsogluteal site or
upper outer quadrant of the
buttock because of the possibility of a suboptimal immune response.
For further information, refer to the current Immunisation Handbook.
Infants:
•
Before 6 months of age, administration of 3 successive 0.5mL doses at
intervals of
one to two months.
•
B