Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Pertussis toxoid, Quantity: 16 microgram/mL; Tetanus toxoid, Quantity: 40 IU/mL; Diphtheria toxoid, Quantity: 4 IU/mL; Pertactin, Quantity: 5 microgram/mL; Pertussis filamentous haemagglutinin, Quantity: 16 microgram/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; aluminium phosphate; sodium chloride
Intramuscular
10 x 0.5mL monodose vials, 1 x 0.5mL monodose vial
(S4) Prescription Only Medicine
BOOSTRIX is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,BOOSTRIX is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION, Section 4.6 FERTILITY, PREGNANCY AND LACTATION and 5.1 PHARMACODYNAMIC PROPERTIES).,The use of BOOSTRIX should be in accordance with official recommendations.
Visual Identification: Turbid liquid with slow settling white deposit, and a colourless supernatant. The precipitate is easily resuspended when shaken.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2009-04-20
BOOSTRIX 1 BOOSTRIX _Combined Diptheria-Tetanus acellular Pertussis (dTpa) Vaccine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about BOOSTRIX 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 having BOOSTRIX against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING BOOSTRIX TALK TO YOUR DOCTOR, NURSE OR PHARMACIST KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT BOOSTRIX IS USED FOR BOOSTRIX is a vaccine used as a booster to prevent three diseases: diphtheria, tetanus and pertussis (whooping cough) in adults and children aged 4 years and older who have been previously vaccinated against these diseases. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. Diphtheria, tetanus, and pertussis are all serious life-threatening diseases caused by bacterial infection. 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 10% of cases. PERTUSSIS (WHOOPING COUGH) Pertussis is a highly infectious illness. The disease affects the breathing tract causing severe spells Læs hele dokumentet
1 AUSTRALIAN PRODUCT INFORMATION BOOSTRIX (COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS (DTPA)) SUSPENSION FOR INJECTION 1 NAME OF THE MEDICINE Combined diphtheria-tetanus-acellular pertussis (dTpa) vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BOOSTRIX dTpa vaccine is a sterile suspension which contains diphtheria toxoid, tetanus toxoid and three purified antigens of _ Bordetella pertussis_ [pertussis toxoid (PT), pertussis filamentous haemagglutinin (FHA) and pertactin (PRN)] adsorbed onto aluminium salts. 1 dose (0.5 mL) contains: Diphtheria toxoid 1 not less than 2 International Units (IU) (2.5 Lf) Tetanus toxoid 1 not less than 20 International Units (IU) (5 Lf) _Bordetella pertussis_ antigens Pertussis toxoid 1 8 micrograms Filamentous Haemagglutinin 1 8 micrograms Pertactin 1 2.5 micrograms 1 adsorbed on aluminium hydroxide hydrate (Al(OH)3) 0.3 milligrams Al3+ and aluminium phosphate (AlPO4) 0.2 milligrams Al3+ 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. No substances of human origin are used in its manufacture. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. This medicine contains less than 1 mmol (39 mg) per dose of potassium and less than 1 mmol (23 mg) per dose of sodium, i.e., essentially ‘potassium-free’ and ‘sodium-free’. 2 3 PHARMACEUTICAL FORM BOOSTRIX is a turbid white suspension for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BOOSTRIX is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION). BOOSTRIX is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION, Section 4.6 FERTILITY, PREGNANCY AND LACTATION an Læs hele dokumentet