Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Pertussis filamentous haemagglutinin, Quantity: 50 microgram/mL; Pertactin, Quantity: 16 microgram/mL; Tetanus toxoid, Quantity: 80 IU/mL; Pertussis toxoid, Quantity: 50 microgram/mL; Diphtheria toxoid, Quantity: 60 IU/mL
GlaxoSmithKline Australia Pty Ltd
Diphtheria toxoid,Pertactin,Pertussis filamentous haemagglutinin,Pertussis toxoid,Tetanus toxoid
Injection, suspension
Excipient Ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride
Intramuscular
0.5mL x syringe x 1, 0.5mL x syringe with needle (Aust L 19009) x 1, 10 x syringe
(S4) Prescription Only Medicine
Infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. INDICATIONS AS OF 8TH JANUARY 1997 - Infanrix (DTPa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. Infanrix (DTPa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.
Visual Identification: White turbid suspension; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2009-12-02
INFANRIX ® 1 INFANRIX ® _Diphtheria-tetanus-acellular pertussis (DTPa) vaccine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before your child is given INFANRIX. This leaflet answers some of the common questions about INFANRIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of your child having INFANRIX against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD RECEIVING INFANRIX TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT INFANRIX IS USED FOR INFANRIX is a vaccine used to prevent three diseases, diphtheria, tetanus, and pertussis (whooping cough). The vaccine is sometimes called DTPa vaccine. Diphtheria, tetanus, and pertussis are all serious life-threatening diseases caused by bacterial infection. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. DIPHTHERIA Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and death. The risk of serious complications and death is greater in the very young and elderly. TETANUS (LOCKJAW) Tetanus bacteria enter the body through wounded skin. Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and death. The spasms can be strong enough to cause bone fractures of the spine. The death rate is 30-40% of cases. PERTUSSIS (WHOOPING COUGH) Pertussis is a highly infectious illness. The disease affects the breathing tra Прочетете целия документ
1 AUSTRALIAN PRODUCT INFORMATION INFANRIX (DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS (DTPA) VACCINE) SUSPENSION FOR INJECTION 1 NAME OF THE MEDICINE Diphtheria-tetanus-acellular pertussis (DTPa) vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION INFANRIX DTPa vaccine is a sterile suspension which contains diphtheria toxoid, tetanus toxoid and three purified antigens of _Bordetella pertussis _[pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)] adsorbed onto aluminium hydroxide hydrate. The diphtheria and tetanus toxins are obtained from cultures of _Corynebacterium diphtheriae_ and _Clostridium tetani_ and are then detoxified and purified. The acellular pertussis vaccine components (PT, FHA and PRN) are extracted from phase I _Bordetella pertussis,_ and are then purified and stabilised. Each 0.5 mL dose of INFANRIX contains not less than 30 IU of diphtheria toxoid, 40 IU of tetanus toxoid, 25 g of PT, 25 g of FHA and 8 g of PRN. The manufacture of this product includes exposure to bovine derived 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. INFANRIX meets the World Health Organisation requirements for biological substances and for diphtheria and tetanus vaccines. No substances of human origin are used in its manufacture. LIST OF EXCIPIENTS WITH KNOWN EFFECT For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Suspension for injection. Turbid white suspension. Upon storage a white deposit and clear supernatant can be observed. 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INFANRIX (DTPa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. INFANRIX (DTPa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or f Прочетете целия документ