देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Diphtheria toxoid, adsorbed 30 [iU] (Not less than); Hepatitis B surface antigen, recombinant 10ug; Pertactin 8ug; Pertussis filamentous haemagglutinin 25ug; Pertussis toxoid, adsorbed 25ug; Polio virus type 1 40 DAgU (/dose); Polio virus type 2 8 DAgU (/dose); Polio virus type 3 32 DAgU (/dose); Tetanus toxoid, adsorbed 40 [iU] (Not less than); Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (Covalently bonded to tetanus toxoid 20 - 40micrograms)
GlaxoSmithKline NZ Limited
Diphtheria toxoid, adsorbed 30 IU (Not less than)
0.5 mL
Suspension for injection
Active: Diphtheria toxoid, adsorbed 30 [iU] (Not less than) Hepatitis B surface antigen, recombinant 10ug Pertactin 8ug Pertussis filamentous haemagglutinin 25ug Pertussis toxoid, adsorbed 25ug Polio virus type 1 40 DAgU (/dose) Polio virus type 2 8 DAgU (/dose) Polio virus type 3 32 DAgU (/dose) Tetanus toxoid, adsorbed 40 [iU] (Not less than) Excipient: Aluminium Medium 199 Sodium chloride Water for injection Active: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (Covalently bonded to tetanus toxoid 20 - 40micrograms) Excipient: Aluminium as aluminium phosphate Lactose
Syringe, glass, single dose, 0.5 mL
Prescription
Prescription
GSK Vaccines GmbH
Infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b.
Package - Contents - Shelf Life: Combination pack, 1 x syringe + 1 x vial - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, 10 x syringes + 10 x vials - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 1 x 0.5 mL - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1999-08-24
INFANRIX HEXA 1 INFANRIX HEXA _Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Inactivated Poliovirus and _ _Haemophilus influenzae type b Vaccine _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given INFANRIX HEXA. This leaflet answers some of the common questions about INFANRIX HEXA 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 HEXA against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD RECEIVING INFANRIX HEXA TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT INFANRIX HEXA IS USED FOR INFANRIX HEXA is a vaccine used to prevent six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and _Haemophilus influenzae_ type b (Hib). The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. Diphtheria, tetanus, pertussis and Hib are all serious life-threatening diseases caused by bacterial infection. Hepatitis B and poliomyelitis are 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, f पूरा दस्तावेज़ पढ़ें
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME INFANRIX HEXA Combined diphtheria-tetanus-acellular pertussis, hepatitis B, enhanced inactivated polio vaccine and _Haemophilus influenzae_ type b powder and suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 mL) contains: Diphtheria toxoid 1 not less than 30 International Units (IU) Tetanus toxoid 1 not less than 40 International Units (IU) _Bordetella pertussis_ antigens Pertussis toxoid (PT) 1 25 micrograms Filamentous Haemagglutinin (FHA) 1 25 micrograms Pertactin (PRN) 1 8 micrograms Hepatitis B surface antigen (HBs) 2,3 10 micrograms Poliovirus (inactivated) (IPV) type 1 (Mahoney strain) 4 40 D-antigen unit type 2 (MEF-1 strain) 4 8 D-antigen unit type 3 (Saukett strain) 4 32 D-antigen unit _Haemophilus influenzae_ type b polysaccharide 10 micrograms (polyribosylribitol phosphate) (PRP) 3 conjugated to tetanus toxoid as carrier protein 20 - 40 micrograms 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.5 milligrams Al 3+ 2 produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant DNA technology 3 adsorbed on aluminium phosphate (AlPO 4 ) 0.32 milligrams Al 3+ 4 propagated in VERO cells For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM 2 Powder and suspension for injection. The DTPa-HBV-IPV component is presented as a turbid white suspension in a syringe. Upon storage, a white deposit and clear supernatant can be observed. This is a normal observation. The Hib component is presented as a white powder in a glass vial. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INFANRIX HEXA is indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and _Haemophilus influenzae_ type b. The use of INFANRIX HEXA should be in accordance with official recommendations. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose The primary vaccination schedule consists of two or three doses of 0.5 mL which sh पूरा दस्तावेज़ पढ़ें