Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
Tetanus toxoid, Quantity: 20 LfU/mL; Poliovirus, Quantity: 80 AgU/mL; Pertussis filamentous haemagglutinin, Quantity: 50 microgram/mL; Poliovirus, Quantity: 16 AgU/mL; Pertactin, Quantity: 16 microgram/mL; Poliovirus, Quantity: 64 AgU/mL; Pertussis toxoid, Quantity: 50 microgram/mL; Diphtheria toxoid, Quantity: 50 LfU/mL
GlaxoSmithKline Australia Pty Ltd
Diphtheria toxoid,Pertactin,Pertussis filamentous haemagglutinin,Pertussis toxoid,Poliovirus,Tetanus toxoid
Injection, solution
Excipient Ingredients: aluminium hydroxide hydrate; water for injections; neomycin sulfate; polymyxin B sulfate; sodium chloride; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium
Intramuscular
10 x single dose pre-filled syringes with and without needle, 1 x single dose pre-filled syringe with and without needle
(S4) Prescription Only Medicine
1. INFANRIX-IPV is indicated for use in a three dose primary schedule for immunisation of infants from 6 weeks of age and over, against diphtheria, tetanus, pertussis and poliomyelitis. INFANRIX-IPV is also indicated as a single booster dose for children, up to and including 6 years of age, who have previously been immunised against diphthereia, tetanus, pertussis and polio.
Visual Identification: Turbid liquid, white deposit, colourless supernatant.; 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
2009-04-30
INFANRIX-IPV 1 INFANRIX-IPV _Combined Diphtheria -Tetanus-acellular Pertussis (DTPa) and Inactivated Poliovirus Vaccine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before your child is given INFANRIX-IPV. This leaflet answers some common questions about INFANRIX-IPV. 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 risks of your child having INFANRIX-IPV against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD RECEIVING THIS VACCINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE VACCINE. You may need to read it again. WHAT INFANRIX-IPV IS USED FOR INFANRIX-IPV is a vaccine used in infants from 6 weeks of age and over to prevent four diseases, diphtheria, tetanus, pertussis (whooping cough) and poliomyelitis (polio). 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 disease 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 সম্পূর্ণ নথি পড়ুন
1 AUSTRALIAN PRODUCT INFORMATION INFANRIX IPV (COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS (DTPA) AND INACTIVATED POLIOVIRUS VACCINE) SUSPENSION FOR INJECTION 1 NAME OF THE MEDICINE Combined diphtheria, tetanus, acellular pertussis (DTPa) and inactivated poliovirus vaccine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 mL) contains: Diphtheria toxoid 1 not less than 30 International units (25 Lf) Tetanus toxoid 1 not less than 40 International units (10 Lf) _Bordetella pertussis_ antigens Pertussis toxoid (PT) 1 25 micrograms Filamentous Haemagglutinin (FHA) 1 25 micrograms Pertactin (PRN) 1 8 micrograms Poliovirus (inactivated) (IPV) 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 hydrate (Al(OH) 3 ) 0.5 milligrams Al 3+ 2 propagated in VERO cells The diphtheria and tetanus toxoids are obtained by formaldehyde treatment of purified Corynebacterium diphtheriae and Clostridium tetani toxins. The acellular pertussis vaccine components are obtained by extraction and purification from phase I Bordetella pertussis cultures, followed by irreversible detoxification of the pertussis toxin by glutaraldehyde and formaldehyde treatment, and formaldehyde treatment of FHA and pertactin. The three polioviruses are cultivated on a continuous VERO cell line, purified and inactivated with formaldehyde. 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. 2 INFANRIX IPV vaccine meets the World Health Organisation requirements for manufacture of biological substances, of diphtheria, tetanus, pertussis and combined vaccines, and of inactivated poliomyelitis vaccines . LIST OF EXCIPIENTS WITH KNOWN EFFECT INFANRIX IPV also contains residual amounts of neomycin sulfate and polymyxin B sulfate, which are carried o সম্পূর্ণ নথি পড়ুন