European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - pramipexole dihydrochloride monohydrate - restless legs syndrome; parkinson disease - anti-parkinson drugs - mirapexin is indicated for treatment of the signs and symptoms of idiopathic parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - zinc sulphate monohydrate. -

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

medis pharma pty ltd - capecitabine -

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

medis pharma pty ltd - capecitabine -

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

physicians total care, inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.500 mg - mirapex® (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic parkinson's disease. the effectiveness of mirapex tablets was demonstrated in randomized, controlled trials in patients with early parkinson's disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa (see clinical studies ). mirapex tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). key diagnostic criteria for rls are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. difficulty falling asleep may frequently be associated with symptoms of rls. mir

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

boehringer ingelheim pharmaceuticals, inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - mirapex tablets are indicated for the treatment of parkinson's disease. mirapex tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of mirapex in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data ]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogen

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

boehringer ingelheim pharmaceuticals, inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.375 mg - mirapex er® tablets are indicated for the treatment of parkinson's disease. none. risk summary there are no adequate data on the developmental risk associated with the use of mirapex er in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data ]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. this incre

Philippines - English - FDA (Food And Drug Administration)

international apex pharmaceuticals, inc.; distributor: international apex pharmaceuticals, inc. - pemetrexed (as disodium hemipentahydrate) - lyophilized powder for intravenous infusion - 500 mg

Philippines - English - FDA (Food And Drug Administration)

international apex pharmaceuticals, inc.; distributor: international apex pharmaceuticals, inc. - pemetrexed (as disodium hemipentahydrate) - lyophilized powder for intravenous infusion - 100 mg

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

fresenius kabi australia pty ltd - moxifloxacin hydrochloride, quantity: 1.75 mg/ml - injection, intravenous infusion - excipient ingredients: sodium sulfate; sulfuric acid; sodium acetate trihydrate; water for injections - moxifloxacin kabi intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions:,- community acquired pneumonia (caused by susceptible organisms),- acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics,- moxifloxacin kabi intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents, (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin.,appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin kabi may be initiated, in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.