United States - English - NLM (National Library of Medicine)

la jolla pharmaceutical company - angiotensin ii (unii: m089efu921) (angiotensin ii - unii:m089efu921) - angiotensin ii 2.5 mg in 1 ml - giapreza increases blood pressure in adults with septic or other distributive shock [see clinical studies (14)] . none. risk summary the published data on angiotensin ii use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. animal reproduction studies have not been conducted with giapreza. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk septic or other distributive shock is a medical emergency that can be fatal if left untreated. delaying treatment in pregnant women with hypotension associated with septic or other distributive shock is likely to incr

Israel - English - Ministry of Health

csl behring ltd., israel - coagulation factor ii (human); coagulation factor ix (human- rfixfc); coagulation factor vii (human); coagulation factor x (human); protein c; protein s antigen - powder and solvent for solution for injection - coagulation factor ii (human) 200 - 480 iu; coagulation factor vii (human) 100 - 250 iu; coagulation factor ix (human- rfixfc) 200 - 310 iu; coagulation factor x (human) 220 - 600 iu; protein c 150 - 450 iu; protein s antigen 120 - 380 iu - coagulation factor ix, ii, vii and x in combination - coagulation factor ix, ii, vii and x in combination - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c - powder and solvent for solution for injection - 600 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination - antihemorrhagics, coagulation factors ix, ii, vii and x in combination - treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin k antagonists or in case of overdose with vitamin k antagonists, when rapid correction of the deficiency is required. treatment and perioperative prophylaxis of hemorrhages in congenital deficiency of vitamin k-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.

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

merck sharp & dohme (australia) pty ltd - rubella virus, quantity: 1000 tcid50; measles virus, quantity: 1000 tcid50; mumps virus, quantity: 12500 tcid50 - injection, powder for - excipient ingredients: hydrolysed gelatin; sorbitol; neomycin; phenolsulfonphthalein; monobasic potassium phosphate; sodium bicarbonate; monosodium glutamate monohydrate; dibasic potassium phosphate; sucrose; monobasic sodium phosphate; dibasic sodium phosphate; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; 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; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - m-m-r ii is indicated for simultaneous immunisation against measles, mumps and rubella.,refer to the nhmrc australian immunisation handbook (aih) for vaccination recommendations and schedule.,there is some evidence to suggest that infants immunised against measles at less than 12 months of age, or who are born to mothers who had wild-type measles and who are vaccinated at less than one year of age may not develop sustained antibody levels when later revaccinated. the advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunisation.,infants who are less than 12 months of age may fail to respond to one or more components of the vaccine due to presence in the circulation of residual antibodies of maternal origin, the younger the infant, the lower the likelihood of seroconversion. in geographically isolated or other relatively inaccessible populations for whom immunisation programmes are logistically difficult, and in population groups in which wild-type measles infections may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. infants vaccinated under these conditions at less than 12 months of age should be revaccinated after reaching 12 to 15 months of age.,previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine to reduce the risk of exposure of the pregnant woman.,non-pregnant adolescent and adult females: immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see 4.4 special warnings and precautions for use and 4.6 fertility, pregnancy and lactation). vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury. congenital malformations do occur in up to seven percent of all live births, and their chance appearance after vaccination should be borne in mind.,women of childbearing age should be advised not to become pregnant for one month after vaccination against rubella (which is included in m-m-r ii) and should be informed of the reasons for this precaution (see 4.6 fertility, pregnancy and lactation, use in pregnancy).,the australian immunisation handbook recommends that effort should be made to identify and immunise non-pregnant seronegative women of child-bearing age.,women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. however, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing. please refer to aih for recommendations for further information regarding serological testing for immunity to rubella.,postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination against rubella (see 4.8 adverse effects (undesirable effects)).,post-partum women it has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period using an appropriate rubella-containing vaccine. (see 4.6 fertility, pregnancy and lactation, use in lactation).,revaccination children vaccinated when younger than 12 months of age should be revaccinated at 12 to 15 months of age. persons who were vaccinated originally when 12 months of age or older should be revaccinated with a mmr-containing vaccine, as per the recommended vaccination schedule. revaccination is intended to seroconvert those who did not respond to the first dose. however, data on long term persistence of antibodies are limited and continued surveillance will be required to allow firm recommendations to be made on revaccination. however, persons should be revaccinated if there is evidence to suggest that initial immunisation was ineffective.

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

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram/ml - injection, suspension - excipient ingredients: aluminium; borax; sodium chloride; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

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

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 5 microgram - injection, suspension - excipient ingredients: borax; water for injections; sodium chloride; aluminium - for use in the immunisation against infection caused by all known subtypes of hepatitis b virus. indications as at 17 november 2000: h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who are at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

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

csl behring australia pty ltd - factor ix, quantity: 500 iu; factor x, quantity: 500 iu; factor ii, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - prothrombinex-vf is indicated in - treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required. - treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiency of factor ix, ii or x when purified specific coagulation factor product is not available (see precautions).

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

merck sharp & dohme (australia) pty ltd - mumps virus, quantity: 12500 tcid50; measles virus, quantity: 1000 tcid50; rubella virus, quantity: 1000 tcid50 - injection, powder for - excipient ingredients: gelatin; neomycin; sorbitol; sucrose; dibasic potassium phosphate; monobasic potassium phosphate; phenolsulfonphthalein; dibasic sodium phosphate; monosodium glutamate monohydrate; sodium bicarbonate; monobasic sodium phosphate; albumin; bovine serum albumin; glucose monohydrate; ascorbic acid; polysorbate 80; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; 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; dibasic sodium phosphate dihydrate; sodium pyruvate; cystine; tyrosine; arginine; histidine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; water for injections - m-m-r ii is indicated for simultaneous immunisation against measles, mumps and rubella.,refer to the nhmrc australian immunisation handbook (aih) for vaccination recommendations and schedule.,there is some evidence to suggest that infants immunised against measles at less than 12 months of age, or who are born to mothers who had wild-type measles and who are vaccinated at less than one year of age may not develop sustained antibody levels when later revaccinated. the advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunisation.,infants who are less than 12 months of age may fail to respond to one or more components of the vaccine due to presence in the circulation of residual antibodies of maternal origin, the younger the infant, the lower the likelihood of seroconversion. in geographically isolated or other relatively inaccessible populations for whom immunisation programmes are logistically difficult, and in population groups in which wild-type measles infections may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. infants vaccinated under these conditions at less than 12 months of age should be revaccinated after reaching 12 to 15 months of age.,previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine to reduce the risk of exposure of the pregnant woman.,non-pregnant adolescent and adult females: immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see 4.4 special warnings and precautions for use and 4.6 fertility, pregnancy and lactation). vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury. congenital malformations do occur in up to seven percent of all live births, and their chance appearance after vaccination should be borne in mind.,women of childbearing age should be advised not to become pregnant for one month after vaccination against rubella (which is included in m-m-r ii) and should be informed of the reasons for this precaution (see 4.6 fertility, pregnancy and lactation, use in pregnancy).,the australian immunisation handbook recommends that effort should be made to identify and immunise non-pregnant seronegative women of child-bearing age.,women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. however, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing. please refer to aih for recommendations for further information regarding serological testing for immunity to rubella.,postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination against rubella (see 4.8 adverse effects (undesirable effects)).,post-partum women it has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period using an appropriate rubella-containing vaccine. (see 4.6 fertility, pregnancy and lactation, use in lactation).,revaccination children vaccinated when younger than 12 months of age should be revaccinated at 12 to 15 months of age. persons who were vaccinated originally when 12 months of age or older should be revaccinated with a mmr-containing vaccine, as per the recommended vaccination schedule. revaccination is intended to seroconvert those who did not respond to the first dose. however, data on long term persistence of antibodies are limited and continued surveillance will be required to allow firm recommendations to be made on revaccination. however, persons should be revaccinated if there is evidence to suggest that initial immunisation was ineffective.

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

merck sharp & dohme (australia) pty ltd - rubella virus, quantity: 1000 tcid50; mumps virus, quantity: 12500 tcid50; measles virus, quantity: 1000 tcid50 - injection, powder for - excipient ingredients: monobasic potassium phosphate; hydrolysed gelatin; monosodium glutamate monohydrate; monobasic sodium phosphate; sodium bicarbonate; neomycin; phenolsulfonphthalein; dibasic potassium phosphate; sorbitol; sucrose; dibasic sodium phosphate; glucose monohydrate; ascorbic acid; polysorbate 80; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; 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; dibasic sodium phosphate dihydrate; sodium pyruvate; cystine; tyrosine; arginine; histidine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; water for injections - m-m-r ii is indicated for simultaneous immunisation against measles, mumps and rubella.,refer to the nhmrc australian immunisation handbook (aih) for vaccination recommendations and schedule.,there is some evidence to suggest that infants immunised against measles at less than 12 months of age, or who are born to mothers who had wild-type measles and who are vaccinated at less than one year of age may not develop sustained antibody levels when later revaccinated. the advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunisation.,infants who are less than 12 months of age may fail to respond to one or more components of the vaccine due to presence in the circulation of residual antibodies of maternal origin, the younger the infant, the lower the likelihood of seroconversion. in geographically isolated or other relatively inaccessible populations for whom immunisation programmes are logistically difficult, and in population groups in which wild-type measles infections may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. infants vaccinated under these conditions at less than 12 months of age should be revaccinated after reaching 12 to 15 months of age.,previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine to reduce the risk of exposure of the pregnant woman.,non-pregnant adolescent and adult females: immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see 4.4 special warnings and precautions for use and 4.6 fertility, pregnancy and lactation). vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury. congenital malformations do occur in up to seven percent of all live births, and their chance appearance after vaccination should be borne in mind.,women of childbearing age should be advised not to become pregnant for one month after vaccination against rubella (which is included in m-m-r ii) and should be informed of the reasons for this precaution (see 4.6 fertility, pregnancy and lactation, use in pregnancy).,the australian immunisation handbook recommends that effort should be made to identify and immunise non-pregnant seronegative women of child-bearing age.,women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. however, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing. please refer to aih for recommendations for further information regarding serological testing for immunity to rubella.,postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination against rubella (see 4.8 adverse effects (undesirable effects)).,post-partum women it has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period using an appropriate rubella-containing vaccine. (see 4.6 fertility, pregnancy and lactation, use in lactation).,revaccination children vaccinated when younger than 12 months of age should be revaccinated at 12 to 15 months of age. persons who were vaccinated originally when 12 months of age or older should be revaccinated with a mmr-containing vaccine, as per the recommended vaccination schedule. revaccination is intended to seroconvert those who did not respond to the first dose. however, data on long term persistence of antibodies are limited and continued surveillance will be required to allow firm recommendations to be made on revaccination. however, persons should be revaccinated if there is evidence to suggest that initial immunisation was ineffective. m-m-r ii is indicated for simultaneous immunisation against measles, mump and rubella. the australian nh&mrc immunisation handbook recommendations for mmr vaccination are as follows. mmr vaccine is recommended for all children at 12 months of age and again at 4 years of age unless there is a genuine contraindication. in populations with a high incidence of early measles, vaccination at 9 months of age is recommended. because of the risk to aboriginal children, the northern territory health authority has adopted a practice of administering the first dose of mmr vaccine to aboriginal children at the age of 9 months. this conforms with who recommendations for such populations. the second dose should be given at 12-15 months of age (see paragraph infants who are less than a 15 months for explanation). unimmunised children in the following groups are at particular risk from severe measles infection: children with chronic conditions such as cystic fibrosis, congenital heart or kidney disease, failure to thrive, down syndrome; children from the age of 1 year upwards in child care centres, family day care and playgroups; children living in institutions; aboriginal and torres strait islander children. hiv positive individuals may be given measles, mumps, rubella combined vaccines in the absence of other contraindications

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

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram/ml - injection, suspension - excipient ingredients: borax; sodium chloride; aluminium; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.