Ireland - English - HPRA (Health Products Regulatory Authority)

mcneil healthcare (ireland) ltd - dimeticone, activated - capsules, soft - 240 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

mcneil healthcare (ireland) ltd - dimeticone, activated - capsules, soft - 240 milligram

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

sanofi-aventis australia pty ltd - rabies immunoglobulin, quantity: 150 iu/ml - injection - excipient ingredients: glycine; sodium chloride; water for injections - imogam rabies pasteurized is indicated in subjects who are thought to have been exposed to rabies virus, especially cases of major exposure, in accordance with w.h.o. recommendations as specified in the international product information.

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

sanofi pasteur inc. - rabies virus strain pm-1503-3m antigen (propiolactone inactivated) (unii: c4hqf74xmw) (rabies virus strain pm-1503-3m antigen (propiolactone inactivated) - unii:c4hqf74xmw) - rabies virus strain pm-1503-3m antigen (propiolactone inactivated) 2.5 [iu] in 1 ml - imovax rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies. imovax rabies vaccine is approved for use in all age groups. physicians must evaluate each possible rabies exposure. local or state public health officials should be consulted if questions arise about the need for prophylaxis. (11) the following factors should be considered before antirabies prophylaxis is initiated. rabid bats have been documented in the 49 continental states, and bats are increasingly implicated as important wildlife reservoirs for variants of rabies virus transmitted to humans. transmission of rabies virus can occur from minor, seemingly underappreciated or unrecognized bites from bats (see table 2). (11) raccoons, skunks, and foxes are the terrestrial carnivores most often infected with rabies in the united states. suggestive clinical signs of rabies among wildlife cannot be interpreted reliably. all bites by such wildlife should be considered possible exposures to rabies virus. post-exposu

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

sanofi pasteur inc. - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 150 [iu] in 1 ml - rabies immune globulin (human) heat treated, imogam rabies – ht, in conjunction with the standard series of rabies vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with rabies vaccine. previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated). (1) inject imogam rabies – ht, as promptly as possible after exposure, along with the first dose of vaccine. if initiation of treatment is delayed for any reason, still administer imogam rabies – ht and the first dose of vaccine, regardless of the interval between exposure and treatment. if rabies immune globulin (human) was not administered when vaccination was begun

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

inova pharmaceuticals (australia) pty ltd - nitrazepam, quantity: 5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch - insomnia, organic and inorganic in origin.

Israel - English - Ministry of Health

medison pharma ltd - mogamulizumab - concentrate for solution for infusion - mogamulizumab 4 mg / 1 ml - mogamulizumab - poteligeo is indicated for the treatment of adult patients with mycosis fungoides (mf) or sézary syndrome (ss) who have received at least one prior systemic therapy.

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

kyowa kirin, inc. - mogamulizumab (unii: yi437801be) (mogamulizumab - unii:yi437801be) - poteligeo is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (mf) or sézary syndrome (ss) after at least one prior systemic therapy. none. risk summary there are no available data on poteligeo use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on auc (see data ). in general, igg molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma. therefore, poteligeo has the potential to be transmitted from the mother to the developing fetus. poteligeo is not recommended during pregnancy or in women of childbearing potential not using contraception. the es

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

sanofi-aventis australia pty ltd - immunoglobulin - rabies -

European Union - English - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - mogamulizumab - sezary syndrome; mycosis fungoides - antineoplastic agents - poteligeo is indicated for the treatment of adult patients with mycosis fungoides (mf) or sézary syndrome (ss) who have received at least one prior systemic therapy.