ACT-HIB Haemophilus type b conjugate vaccine powder for injection with needle free diluent syringe

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

Haemophilus type B polysaccharide, Quantity: 10 microgram; Tetanus protein, Quantity: 18 microgram

Предлага се от:

Sanofi-Aventis Australia Pty Ltd

INN (Международно Name):

Haemophilus type B polysaccharide,Tetanus protein

Лекарствена форма:

Injection, powder for

Композиция:

Excipient Ingredients: trometamol; sucrose

Начин на приложение:

Intramuscular, Subcutaneous

Броя в опаковка:

1 x single dose vaccine powder in vial and 1 x 0.5 mL diluent in pre-filled syringe with 2 separate needles, 10 x single dose vaccine powder in vial and 10 x 0.5mL diluent in pre-filled syringe with 20 separate needles

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

For use in infants from 2 months to 5 years of age for active immunization against invasive disease caused by the Haemophilus influenzae type b.

Каталог на резюме:

Visual Identification: Lyophilised vaccine: type 1 glass vial sealed with elastomer stopper and aluminium/plastic seal.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

2006-12-06

Листовка

ACT-HIB
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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

Данни за продукта

act-ccdsv10-piv4-11feb22
Page 1 of 8
AUSTRALIAN PRODUCT INFORMATION
ACT-HIB _HAEMOPHILUS_ TYPE B CONJUGATE VACCINE
(CONJUGATED TO TETANUS PROTEIN)
1
NAME OF THE MEDICINE
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
immunization 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 origins.
NOTE: Under no circumstances should the tetanus protein component of
this vaccine be
substituted for the routine Tetanus vaccination.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
After reconstitution, the vaccine should be administered via the
intramuscular or
subcutaneous route.
act-ccdsv10-piv4-11feb22
Page 2 of 8
The preferred injection site for children under 2 years of age is
anterolateral thigh. In older
children the vaccine may be given at the anterolateral thigh or
deltoid region.
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:
2-6 months age – 3 injections at 1 or 2 month intervals.
7-11 months age