Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: monobasic sodium phosphate; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - diphtheria toxoid, quantity: 2 iu; pertussis toxoid, quantity: 8 microgram; tetanus toxoid, quantity: 20 iu; pertactin, quantity: 2.5 microgram; pertussis filamentous haemagglutinin, quantity: 8 microgram; poliovirus, quantity: 32 agu - injection, suspension - excipient ingredients: polysorbate 80; aluminium hydroxide hydrate; sodium chloride; neomycin sulfate; water for injections; aluminium phosphate; polymyxin b sulfate; glucose monohydrate; ascorbic acid; 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 - boostrix-ipv is indicated for booster vaccination against diphtheria, tetanus, pertussis and polio of individuals from the age of four years onwards.,boostrix-ipv is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see section 4.2 dose and method of administration, section 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties).,the nhmrc currently recommends only 4 doses of polio vaccines in childhood, and that polio boosters for adults are not necessary unless they are at special risk, such as:,? travellers to areas or countries where poliomyelitis is epidemic or endemic;,? health care workers in possible contact with poliomyelitis cases.,for those exposed to continuing risk of infection a single booster dose is desirable every 10 years.,the nhmrc currently recommends boosting against diphtheria, tetanus and pertussis using an adolescent/adult formulation dtpa at 15 to 17 years of age. before the eighth birthday, dtp-containing vaccines should be given, as they contain a larger dose of diphtheria toxoid. after the eighth birthday, smaller doses of toxoid (adult/adolescent formulation dtpa or dt-containing vaccines) should be given.,a booster dose of dtpa is also recommended:,? before planning pregnancy, or for both parents as soon as possible after delivery of an infant,? for adults working with young children,? for any adult expressing an interest in receiving a booster dose of dtpa, provided that a primary course of dtp vaccine has been given in the past.,clinical data has demonstrated that in adults with an unknown history of pertussis vaccination, the majority had an immunogenic response to pertussis when given boostrix-ipv (see section 5.1 pharmacodynamic properties).,finally, all adults who reach the age of 50 years without having received a boosting dose of dt in the previous 5 years should receive a further boosting dose of dt, where the adult/adolescent formulation dtpa can be used instead.,boostrix-ipv is not intended for primary immunisation.

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - tetanus toxoid, quantity: 40 iu; pertussis fimbriae 2 + 3, quantity: 5 microgram; diphtheria toxoid, quantity: 30 iu; poliovirus, quantity: 29 dagu; poliovirus, quantity: 26 dagu; poliovirus, quantity: 7 dagu; pertussis toxoid, quantity: 20 microgram; pertactin, quantity: 3 microgram; pertussis filamentous haemagglutinin, quantity: 20 microgram - injection, suspension - excipient ingredients: polymyxin b sulfate; bovine serum albumin; formaldehyde; phenoxyethanol; glutaral; neomycin; water for injections; polysorbate 80; aluminium phosphate - quadracel is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis, and poliomyelitis.,quadracel is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - pertussis filamentous haemagglutinin, quantity: 10 microgram/ml; pertussis fimbriae 2 + 3, quantity: 10 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis toxoid, quantity: 20 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml; pertactin, quantity: 6 microgram/ml - injection, suspension - excipient ingredients: aluminium phosphate; water for injections; phenoxyethanol - tripacel is indciated for primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. tripacel is also indicated for the fourth and fifth dose for children from 15 months of age up to their eighth birthday who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines.

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis vaccines and diagnostics gmbh - diphtheria toxoid pertussis vaccine tetanus toxoid aluminium hydroxide sodium timerfonate aluminium phosphate - suspension for injection - 0.5 millilitre

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis vaccines and diagnostics gmbh - diphtheria toxoid pertussis vaccine tetanus toxoid aluminium hydroxide sodium timerfonate aluminium phosphate - suspension for injection - 5 millilitre

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis vaccines and diagnostics gmbh - diphtheria toxoid pertussis vaccine tetanus toxoid aluminium hydroxide sodium timerfonate aluminium phosphate - suspension for injection - 10 millilitre

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a clinect nz pty ltd - haemophilus influenzae type b vaccine 10ug (conjugated to tetanus protein (18-30µg)) - injection with diluent - 10 mcg/0.5ml - active: haemophilus influenzae type b vaccine 10ug (conjugated to tetanus protein (18-30µg)) excipient: hydrochloric acid sucrose trometamol sodium chloride water for injection - act-hib is indicated for use in infants from 2 months to 5 years of age for active immunisation against invasive disease caused by the haemophilus influenzae type b.

Singapore - English - HSA (Health Sciences Authority)

qt instruments (s) pte ltd - pentetic acid - injection, powder, for solution - 25 mg/vial - pentetic acid 20.8 mg/vial

Ireland - English - HPRA (Health Products Regulatory Authority)

gsk vaccines s.r.l. - meningococcal group c oligosaccharide; corynebacterium diphtheriae crm197 protein - suspension for injection in pre-filled syringe - 10 - meningococcal vaccines; other meningococcal polyvalent purified polysaccharides antigen - meningococcal vaccines - active immunisation of children from 2 months of age, adolescents and adults, for the prevention of invasive disease caused by neisseria meningitidis group c.