Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
Tetanus toxoid, Quantity: 40 IU; Pertussis fimbriae 2 + 3, Quantity: 5 microgram; Diphtheria toxoid, Quantity: 30 IU; Poliovirus, Quantity: 29 DAgU; Poliovirus, Quantity: 26 DAgU; Poliovirus, Quantity: 7 DAgU; Pertussis toxoid, Quantity: 20 microgram; Pertactin, Quantity: 3 microgram; Pertussis filamentous haemagglutinin, Quantity: 20 microgram
Sanofi-Aventis Australia Pty Ltd
Injection, suspension
Excipient Ingredients: polymyxin B sulfate; bovine serum albumin; formaldehyde; phenoxyethanol; glutaral; neomycin; water for injections; polysorbate 80; aluminium phosphate
Intramuscular
10 monodose vials, 1 monodose vials, 5 monodose vials
(S4) Prescription Only Medicine
Quadracel is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis, and poliomyelitis.,Quadracel is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.
Visual Identification: Sterile, uniform, cloudy, white to off-white suspension; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2002-10-22
QUADRACEL ® Q U A D R A C E L ® 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 DOES MY CHILD NEED QUADRACEL? Quadracel is a vaccine. It is used to help prevent whooping cough (pertussis), tetanus, diphtheria and polio, in infants and children. For more information, see Section 1. Why does my child need Quadracel? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE MY CHILD IS GIVEN QUADRACEL? Do not use if your child ever had an allergic reaction to Quadracel or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOUR CHILD HAS OR 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 Quadracel? in the full CMI. 3. WHAT IF MY CHILD IS TAKING OTHER MEDICINES? Some medicines may interfere with Quadracel 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 QUADRACEL IS GIVEN? Quadracel is given by a doctor or nurse as an injection into muscle. More instructions can be found in Section 4. How is Quadracel given? in the full CMI. 5. WHAT SHOULD I KNOW AFTER MY CHILD IS GIVEN QUADRACEL? THINGS YOU SHOULD DO • Keep an updated record of vaccinations. • Keep follow-up appointments with your doctor or clinic. LOOKING AFTER YOUR MEDICINE Quadracel is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However, if you need to store Quadracel: • keep in the fridge between 2-8°C. Do not freeze. For more information, see Section 5. What should I know after my child is given Quadracel? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? Common side effects include local reaction around the injection site (redness, swelling, and tenderness), vomiting, fever, crying, decreased eating, diarrhoea, fussiness, decreased activity, sleepiness, listlessness. Serious side effects include abscess Citiți documentul complet
quad-ccdsv8-piv5-24may22 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – QUADRACEL (PERTUSSIS VACCINE - ACELLULAR AND DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED) COMBINED WITH INACTIVATED POLIOVIRUS TYPES 1, 2 AND 3 (VERO CELL)) 1 NAME OF THE MEDICINE Pertussis Vaccine-Acellular and Diphtheria and Tetanus Toxoids (Adsorbed) Combined with Inactivated Poliovirus Types 1, 2 and 3 (Vero Cell). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5mL dose of Quadracel contains: Diphtheria toxoid ≥ 30 IU (15 Lf) Tetanus toxoid ≥ 40 IU (5 Lf) Pertussis toxoid (PT) 20 microgram Pertussis filamentous haemagglutinin (FHA) 20 microgram Pertactin (PRN) 3 microgram Pertussis fimbriae 2 + 3 (FIM) 5 microgram Poliovirus inactivated type 1, Vero (Mahoney) 40 D-antigen Units Poliovirus inactivated type 2, Vero (MEF-1) 8 D-antigen Units Poliovirus inactivated type 3, Vero (Saukett) 32 D-antigen Units Absorbed on 1.5 mg Aluminium phosphate (0.33 mg aluminium) This product does not contain thiomersal. The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of variant Creutzfeldt–Jakob disease (vCJD) (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. Diphtheria toxoid is a cell-free preparation of diphtheria toxin detoxified with formaldehyde. Tetanus toxoid is prepared by detoxification of tetanus toxin with formaldehyde. Each of the three strains of poliovirus is individually grown in Vero cells cultivated on microcarriers. The single virus harvest is concentrated and purified, then inactivated with formaldehyde to produce the type 1, 2 or 3 monovalent. Monovalents of each type are then combined in appropriate quantities to produce a trivalent concentrate. The 5 component pertussis antigens, pertussis toxoid (PT), pertussis filamentous haemagglutinin (FHA), pertactin (PRN) and pertussis fimbriae types 2 + 3 (FIM), contained in Quadracel are the same as those in TRIPACEL or PEDIACEL. TRIPACEL consists of a Citiți documentul complet