Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.5 mg - tablet - excipient ingredients: pregelatinised maize starch; mannitol; microcrystalline cellulose; povidone; purified talc; magnesium stearate - the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.25 mg - tablet - excipient ingredients: pregelatinised maize starch; mannitol; microcrystalline cellulose; povidone; purified talc; magnesium stearate - the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa. the symptomatic treatment of primary restless legs syndrome.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.125 mg - tablet - excipient ingredients: pregelatinised maize starch; mannitol; microcrystalline cellulose; povidone; purified talc; magnesium stearate - the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa. the symptomatic treatment of primary restless legs syndrome.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

bryant ranch prepack - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.25 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. pramipexole dihydrochloride 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 pramipexole dihydrochloride tablets 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 pramipexo

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

carilion materials management - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 1.5 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. none. pregnancy category c there are no adequate and well-controlled studies in pregnant women. pramipexole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pramipexole was given to female rats throughout pregnancy, implantation was inhibited at a dose of 2.5 mg/kg/day (5 times the maximum recommended human dose (mrhd) for parkinson's disease of 4.5 mg/day on a body surface area (mg/m2 ) basis). administration of 1.5 mg/kg/day of pramipexole to pregnant rats during the period of organogenesis (gestation days 7 through 16) resulted in a high incidence of total resorption of embryos. the plasma auc in rats at this dose was 4 times the auc in humans at the mrhd. these findings are thought to be due to the prolactin-lowering effect of pramipexole, since prolactin is necessary for implantation and maintenance of early pregnancy in rats (but not rabbits or humans).

Европска Унија - Енглески - EMA (European Medicines Agency)

accord healthcare s.l.u. - pramipexole dihydrochloride monohydrate - parkinson disease; restless legs syndrome - anti-parkinson drugs - pramipexole accord is indicated in adults 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).

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.5 mg (equivalent: pramipexole, qty 0.35 mg) - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; microcrystalline cellulose - ? treatment of signs and symptoms of idiopathic parkinson?s disease. it may be used as monotherapy or in combination with levodopa ? the symptomatic treatment of primary restless legs syndrome.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.25 mg (equivalent: pramipexole, qty 0.18 mg) - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; microcrystalline cellulose - ? treatment of signs and symptoms of idiopathic parkinson?s disease. it may be used as monotherapy or in combination with levodopa ? the symptomatic treatment of primary restless legs syndrome.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.125 mg (equivalent: pramipexole, qty 0.088 mg) - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; microcrystalline cellulose - ? treatment of signs and symptoms of idiopathic parkinson?s disease. it may be used as monotherapy or in combination with levodopa ? the symptomatic treatment of primary restless legs syndrome.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.5 mg (equivalent: pramipexole, qty 0.35 mg) - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; microcrystalline cellulose - treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.