Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
Diphtheria toxoid, Quantity: 2 IU; Pertussis filamentous haemagglutinin, Quantity: 5 microgram; Pertussis toxoid, Quantity: 2.5 microgram; Pertussis fimbriae 2 + 3, Quantity: 5 microgram; Pertactin, Quantity: 3 microgram; Tetanus toxoid, Quantity: 20 IU
Sanofi-Aventis Australia Pty Ltd
Injection, suspension
Excipient Ingredients: glutaral; formaldehyde; phenoxyethanol; water for injections; aluminium phosphate
Intramuscular
10 x pre-filled needle-free syringes with 20 needles, 10 x pre-filled needle-free syringes with 10 needles, 1 x pre-filled needle-free syringe, 10 x pre-filled needle-free syringes, 1 x pre-filled needle-free syringe with one needle, 1 x pre-filled needle-free syringe with two needles
(S4) Prescription Only Medicine
Adacel is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation. Adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.
Visual Identification: Sterile, uniform, cloudy, white suspension.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-03-29
ADACEL ® A D 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 AM I USING ADACEL? Adacel is a vaccine. It is used to help prevent whooping cough (pertussis), tetanus and diphtheria in persons aged 10 years and over as a booster following primary immunisation. Use of Adacel during pregnancy allows antibodies to be passed to the baby in the womb from the pregnant woman to protect the baby from whooping cough during the first few months of life. For more information, see Section 1. Why am I using Adacel? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ADACEL? Do not use if you have ever had an allergic reaction to Adacel or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Adacel? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Adacel and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ADACEL? Adacel is given as an injection, usually into your upper arm muscle by a doctor or nurse. More instructions can be found in Section 4. How do I use Adacel? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ADACEL? THINGS YOU SHOULD DO • Tell your doctor or nurse before you receive this vaccine if you: • are allergic to the active substances or any of the other ingredients in this vaccine • are currently suffering from an illness • had serious encephalopathy (disease of brain) without an apparent cause within 7 days of a previous pertussis, tetanus or diphtheria vaccination THINGS YOU SHOULD NOT DO • Do not have Adacel if you have a history of severe allergic reactions to any of the ingredients listed, previous dose of this v Lees het volledige document
Page 1 of 15 ada-ccdsv20-piv4-10dec21 AUSTRALIAN PI – ADACEL ® PERTUSSIS VACCINE-ACELLULAR COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED) 1 NAME OF THE MEDICINE ADACEL Pertussis Vaccine-Acellular Combined with Diphtheria and Tetanus Toxoids (Adsorbed) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mL dose of Adacel contains: Diphtheria toxoid ≥ 2 IU (2 Lf) Tetanus toxoid ≥ 20 IU (5 Lf)* Pertussis toxoid 2.5 micrograms Pertussis filamentous haemagglutinin 5 micrograms Pertactin 3 micrograms Pertussis fimbriae 2+3 5 micrograms Adsorbed on aluminium phosphate 1.5 mg (0.33 mg aluminium) *The formulated content of 5 Lf of tetanus toxoid per 0.5mL dose is the same as the related product Tripacel ® . This vaccine may contain traces of formaldehyde and glutaral which are used during the manufacturing process. For the full list of excipients, see Section 6.1 List of excipients. The vaccine is prepared from: purified, formaldehyde-detoxified and adsorbed diphtheria and tetanus toxins; purified, glutaral-detoxified and adsorbed pertussis toxin (pertussis toxoid or PT); purified, formaldehyde-treated and adsorbed filamentous haemagglutinin (FHA); purified and adsorbed pertactin (PRN) and co-purified and adsorbed fimbriae types 2 and 3 (FIM). Adacel is an adult/adolescent formulation diphtheria-tetanus-acellular pertussis (dTpa) combination vaccine with reduced content of pertussis toxoid, filamentous haemagglutinin and diphtheria toxoid compared to paediatric diphtheria-tetanus-acellular pertussis (DTPa) formulations. The manufacture of this product includes exposure to bovine 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. Page 2 of 15 ada-ccdsv20-piv4-10dec21 3 PHARMACEUTICAL FORM Sterile suspension for injection. Adacel appears as a sterile, uniform, cloudy, white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adacel is indicated for active immunis Lees het volledige document