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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 16 dagu; poliovirus, quantity: 64 dagu; poliovirus, quantity: 80 dagu - injection, suspension - excipient ingredients: aluminium phosphate; sodium chloride; aluminium hydroxide hydrate; neomycin sulfate; polymyxin b sulfate; water for injections; 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 - infanrix hexa is indicated for primary immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, and haemophilus influenzae type b. infanrix hexa is also indicated for use as booster dose if boosting with hepatitis b, poliomyelitis, and haemophilus influenzae type b, as well as diphtheria, tetanus and pertussis is required. refer to dosage and administration for further information.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis b surface antigen, recombinant 20 µg/ml; hepatitis b surface antigen, recombinant 20 µg/ml - suspension for injection - 10 mcg/0.5ml - active: hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium hydroxide dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate phenoxyethanol sodium chloride thiomersal water for injection active: hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium hydroxide dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection - engerix-b is indicated for active immunization against hepatitis b virus infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis b surface antigen, recombinant 20 µg/ml; hepatitis b surface antigen, recombinant 20 µg/ml - suspension for injection - 20 mcg/ml - active: hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium hydroxide dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate phenoxyethanol sodium chloride thiomersal water for injection active: hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium hydroxide dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection - engerix-b is indicated for active immunization against hepatitis b virus infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - octocog alfa 2000 [iu] (recombinant factor viii) - injection with diluent - 2000 iu - active: octocog alfa 2000 [iu] (recombinant factor viii) excipient: calcium chloride glycine histidine polysorbate 80 sodium chloride sucrose water for injection water for injection - kogenate fs is indicated in congenital factor viii deficiency (haemophilia a) for the treatment and prophylaxis of bleeding in untreated and previously treated patients without inhibitors.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - octocog alfa 3000 [iu] (recombinant factor viii) - injection with diluent - 3000 iu - active: octocog alfa 3000 [iu] (recombinant factor viii) excipient: calcium chloride glycine histidine polysorbate 80 sodium chloride sucrose water for injection water for injection - kogenate fs is indicated in congenital factor viii deficiency (haemophilia a) for the treatment and prophylaxis of bleeding in untreated and previously treated patients without inhibitors.

Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

recombinant human erythropoetin 4000iu/0.8ml, citric acid 0.6ml., sodium citrate 5.8mg, sodium chloride, human serum albumin

Malta - English - Medicines Authority

eli lilly & co. limited - insulin recombinant, human - suspension for injection - insulin recombinant, human 100 iu/ml - drugs used in diabetes

Malta - English - Medicines Authority

eli lilly & co. limited - insulin recombinant, human - solution for injection - insulin recombinant, human 100 iu/ml - drugs used in diabetes

Malta - English - Medicines Authority

eli lilly & co. limited - insulin recombinant, human - suspension for injection - insulin recombinant, human 100 iu/ml - drugs used in diabetes

European Union - English - EMA (European Medicines Agency)

valneva sweden ab - recombinant cholera toxin b subunit, vibrio cholerae 01 - cholera; immunization - vaccines - dukoral is indicated for active immunisation against disease caused by vibrio cholerae serogroup o1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.the use of dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions.dukoral should not replace standard protective measures. in the event of diarrhoea measures of rehydration should be instituted.