País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
Haemophilus type B polysaccharide, Quantity: 10 microgram; Tetanus protein, Quantity: 18 microgram
Sanofi-Aventis Australia Pty Ltd
Haemophilus type B polysaccharide,Tetanus protein
Injection, powder for
Excipient Ingredients: trometamol; sucrose
Intramuscular, Subcutaneous
single dose powder, 1 x 0.5mL diluent
(S4) Prescription Only Medicine, Not scheduled. Not considered by committee
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.
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
Registered
1993-04-21
ACT-HIB ® A c t - H I B ® 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 Llegiu el document complet
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 Llegiu el document complet