Estados Unidos - inglés - NLM (National Library of Medicine)

zydus lifesciences limited - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.375 mg - pramipexole dihydrochloride extended-release 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 pramipexole 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 2-4% and 15-20%, 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

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

apotex pty ltd - pramipexole dihydrochloride monohydrate -

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

apotex pty ltd - pramipexole dihydrochloride monohydrate -

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

apotex pty ltd - pramipexole dihydrochloride monohydrate -

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 1 mg (equivalent: pramipexole, qty 0.7 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.

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 1 mg (equivalent: pramipexole, qty 0.7 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.

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

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate -

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

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate -

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

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate, quantity: 1.5 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.

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

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate, quantity: 1 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.