País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Diphtheria toxoid, adsorbed 30 [iU]; Pertactin 8ug; Pertussis filamentous haemagglutinin 25ug; Pertussis toxoid, adsorbed 25ug; Tetanus toxoid, adsorbed 40 [iU]; Diphtheria toxoid, adsorbed 30 [iU]; Pertactin 8ug; Pertussis filamentous haemagglutinin 25ug; Pertussis toxoid, adsorbed 25ug; Tetanus toxoid, adsorbed 40 [iU]
GlaxoSmithKline NZ Limited
Detoxified pertussis toxin 25 µg
0.5 mL
Suspension for injection
Active: Diphtheria toxoid, adsorbed 30 [iU] Pertactin 8ug Pertussis filamentous haemagglutinin 25ug Pertussis toxoid, adsorbed 25ug Tetanus toxoid, adsorbed 40 [iU] Excipient: Aluminium as Aluminium hydroxide & phosphate Sodium chloride Water for injection Active: Diphtheria toxoid, adsorbed 30 [iU] Pertactin 8ug Pertussis filamentous haemagglutinin 25ug Pertussis toxoid, adsorbed 25ug Tetanus toxoid, adsorbed 40 [iU] Excipient: Aluminium as Aluminium hydroxide & phosphate Phenoxyethanol Polysorbate 80 Sodium chloride Water for injection
Syringe, glass, 0.5mL, 1 dose unit
Prescription
Prescription
GlaxoSmithKline Biologicals SA
INFANRIX (DTPa) is indicated for active primary immunisation against diptheria, tetanus and pertussis. INFANRIX is indicated as fourth and/or fifth dose for children from 15 months of age up to and including 6 years of age who have previously been immunised with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.
Package - Contents - Shelf Life: Syringe, glass, 0.5mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 0.5mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1994-06-10
1 INFANRIX ® Combined diphtheria, tetanus, acellular pertussis (DTPa) vaccine CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? 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 INFANRIX TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT IS INFANRIX USED FOR INFANRIX is a vaccine used to immunise against diphtheria, tetanus and pertussis (whooping cough). The vaccine is sometimes called DTPa vaccine. INFANRIX is not intended for use in adults. Diphtheria, pertussis and tetanus are three life-threatening diseases caused by bacterial infection. The vaccine works by causing the body to produce its own protection (antibodies) against the disease. DIPHTHERIA Diphtheria is a bacterium that lives in the airways of humans and can also affect the skin. Generally, the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria 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 burn wounds, fractures, deep wounds or wounds contaminated with soil, dust, horse manure or wood splinters. The bacteria release toxins, which can cause muscle stiffness, painful spasms, fits and death. The spasm can be strong enough to cause bone fractures of the spine. PERTUSSIS (Whooping cough) Pertussis is highly infectious. It affects the breathing tract causing severe spells of coughing that may interfere with normal breathing. The coughing is often accompanied Leer el documento completo
NEW ZEALAND DATA SHEET 1. PRODUCT NAME INFANRIX diphtheria-tetanus-acellular pertussis (DTPa) vaccine suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION INFANRIX contains diphtheria toxoid, tetanus toxoid and three purified pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)] adsorbed onto aluminium salts. A 0.5 mL dose of the vaccine contains: Diptheria toxoid not less than 30 International Units (IU) Tetanus toxoid not less than 40 International Units (IU) Bordetella pertussis antigens Pertussis toxoid (PT) 25 micrograms ( g) Pertussis Filamentous Haemagglutinin (FHA) 25 micrograms ( g) Pertactin (PRN) (69 kiloDalton (kDa) outer membrane protein) 8 micrograms ( g) 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 prepared by growing phase I Bordetella pertussis from which the PT and FHA and PRN are extracted, purified and treated with formaldehyde; PT is irreversibly detoxified. The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine components are adsorbed on aluminium salts. The final vaccine is formulated in saline. INFANRIX meets the World Health Organisation requirements for manufacture of biological substances and for diphtheria and tetanus vaccines. No substances of human origin are used in its manufacture. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Suspension for injection. INFANRIX is presented as a turbid white suspension in a glass prefilled syringe. Upon storage, a white deposit and clear supernatant is observed. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INFANRIX (DTPa) is indicated for active primary immunisation against diptheria, tetanus and pertussis. INFANRIX is indicated as fourth and/or fifth dose for children from 15 months of age up to and including 6 years of age who have previous Leer el documento completo