Country: Նոր Զելանդիա
language: անգլերեն
source: Medsafe (Medicines Safety Authority)
Diphtheria toxoid, adsorbed 2 [iU] (2.5LfU); Pertactin 2.5ug; ; Pertussis filamentous haemagglutinin 8ug; ; Pertussis toxoid, adsorbed 8ug; ; Polio virus type 1 40 DAgU; ; Polio virus type 2 8 DAgU; ; Polio virus type 3 32 DAgU; ; Tetanus toxoid 20 [iU] (5LfU)
GlaxoSmithKline NZ Limited
Diphtheria toxoid, adsorbed 2.5 Lf U (2IU)
0.5 mL
Suspension for injection
Active: Diphtheria toxoid, adsorbed 2 [iU] (2.5LfU) Pertactin 2.5ug Pertussis filamentous haemagglutinin 8ug Pertussis toxoid, adsorbed 8ug Polio virus type 1 40 DAgU Polio virus type 2 8 DAgU Polio virus type 3 32 DAgU Tetanus toxoid 20 [iU] (5LfU) Excipient: Aluminium Medium 199 Sodium chloride Water for injection
Syringe, glass, 0.5mL, 1 dose unit
Prescription
Prescription
GSK Vaccines GmbH
BOOSTRIX®-IPV is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of four years onwards. BOOSTRIX®-IPV is not intended for primary immunisation.
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) protect from light 8 hours not refrigerated stored below 21°C - Syringe, glass, 10 x 0.5mL doses - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours not refrigerated stored below 21°C
2003-07-18
1 BOOSTRIX ® -IPV Combined diphtheria-Tetanus-acellular pertussis (dTpa) and Inactivated Poliovirus Vaccine CONSUMER MEDICINE INFORMATION LEAFLET WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about BOOSTRIX-IPV 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-IPV against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING BOOSTRIX-IPV TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again WHAT BOOSTRIX-IPV IS USED FOR BOOSTRIX-IPV is a vaccine used as a booster to prevent four diseases, diphtheria, tetanus, pertussis (whooping cough) and poliomyelitis (polio) 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. Poliomyelitis is an infectious diseases caused by viral 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% read_full_document
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME BOOSTRIX-IPV Combined diphtheria-tetanus-acellular pertussis (dTpa) and enhanced inactivated polio suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BOOSTRIX-IPV contains diphtheria toxoid, tetanus toxoid, and three purified pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN/69 kiloDalton outer membrane protein) adsorbed on aluminium salts. It also contains three types of inactivated polio viruses (type 1: Mahoney strain; type 2: MEF-1 strain; type 3: Saukett strain). 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 Inactivated poliovirus type 1 (Mahoney strain) 2 40 D-antigen unit type 2 (MEF-1 strain) 2 8 D-antigen unit type 3 (Saukett strain) 2 32 D-antigen unit 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.3 milligrams Al 3+ and aluminium phosphate (AlPO 4 ) 0.2 milligrams Al 3+ 2 propagated in VERO cells The final vaccine also contains aluminium hydroxide and aluminium phosphate as adjuvants, sodium chloride, Medium 199, water for injections, and traces of neomycin sulfate and polymyxin sulfate. 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. For the full list of excipients, see section 6.1 List of excipients. 2 3. PHARMACEUTICAL FORM Suspension for injection. BOOSTRIX-IPV is a turbid white suspension presented in a prefilled syringe. Upon storage, a white deposit and clear supernatant can be observed. This is a normal finding. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BOOSTRIX-IPV is indicated for booster vaccination against diphtheria, read_full_document