Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Hepatitis B surface antigen recombinant, Quantity: 20 microgram/mL; Pertactin, Quantity: 16 microgram/mL; Poliovirus, Quantity: 16 DAgU; Pertussis filamentous haemagglutinin, Quantity: 50 microgram/mL; Diphtheria toxoid, Quantity: 30 IU; Tetanus toxoid, Quantity: 40 IU; Pertussis toxoid, Quantity: 50 microgram/mL; Poliovirus, Quantity: 80 DAgU; Poliovirus, Quantity: 64 DAgU
GlaxoSmithKline Australia Pty Ltd
Diphtheria toxoid,Hepatitis B surface antigen recombinant,Pertactin,Pertussis filamentous haemagglutinin,Pertussis toxoid,Poliov
Injection, suspension
Excipient Ingredients: aluminium phosphate; aluminium hydroxide hydrate; polymyxin B sulfate; water for injections; sodium chloride; neomycin sulfate; 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
1 x pre-filled syringe, 10 x pre-filled syringe
(S4) Prescription Only Medicine
INDICATIONS: Infanrix Penta is indicated for immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis. Infanrix Penta may also be used as a booster dose at 18 months of age if boosting with hepatitis B and poliomyelitits, as well as diphtheria, tetanus and pertussis is required.
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
Licence status A
2007-01-08
INFANRIX ® PENTA 1 INFANRIX ® PENTA _Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B and Inactivated Poliovirus Vaccine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before your child is given INFANRIX PENTA. This leaflet answers some common questions about INFANRIX PENTA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of your child having INFANRIX PENTA against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD RECEIVING INFANRIX PENTA, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE VACCINE. You may need to read it again. WHAT INFANRIX PENTA IS USED FOR INFANRIX PENTA is a vaccine used in infants from the age of 6 weeks to prevent five diseases; diphtheria, tetanus, pertussis (whooping cough), hepatitis B 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. 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, fits and death. The spasms can be strong enou Læs hele dokumentet