Израел - Енглески - Ministry of Health

glaxo smith kline (israel) ltd - ropinirole as hydrochloride - film coated tablets - prolonged release - ropinirole as hydrochloride 8 mg - ropinirole - ropinirole - treatment of parkinson’s disease under the following conditions:• initial treatment as monotherapy, in order to delay the introduction of levodopa• in combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur (“end of dose” or “on-off” type fluctuations)."

Нови Зеланд - Енглески - Medsafe (Medicines Safety Authority)

apotex nz ltd - ropinirole hydrochloride 2.28mg equivalent to to 2 mg ropinirole - film coated tablet - 2 mg - active: ropinirole hydrochloride 2.28mg equivalent to to 2 mg ropinirole excipient: citric acid hyprolose hypromellose iron oxide red lactose macrogol 8000 magnesium stearate titanium dioxide - ropinirole is indicated for the treatment of parkinson's disease. ropinirole is effective as early therapy in patients requiring dopaminergic therapy. in a comparative study, ropinirole was superior to bromocriptine. when these two drugs were administered concomitantly with selegiline there was no difference between them. ropinirole delays the need for initiation of l-dopa therapy. as adjunctive treatment of l-dopa, ropinirole enhances the efficacy of l-dopa, including control of "on-off" fluctuations and "end of dose" effects associated with chronic l-dopa therapy and permits reduction in daily l-dopa dose.

Израел - Енглески - Ministry of Health

teva pharmaceutical industries ltd, israel - ropinirole as hydrochloride - film coated tablets - ropinirole as hydrochloride 0.25 mg - ropinirole - ropinirole - treatment of idiopathic parkinson's disease : ropinirole may be used alone in the treatment of idiopathic parkinson's disease.addition of ropinirole to levodopa may be used to control " on - off " fluctuations and permit a reduction in the total daily dose of levodopa.

Израел - Енглески - Ministry of Health

teva pharmaceutical industries ltd, israel - ropinirole as hydrochloride - film coated tablets - ropinirole as hydrochloride 2 mg - ropinirole - ropinirole - treatment of idiopathic parkinson's disease : ropinirole may be used alone in the treatment of idiopathic parkinson's disease.addition of ropinirole to levodopa may be used to control " on - off " fluctuations and permit a reduction in the total daily dose of levodopa.

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

aphena pharma solutions - tennessee, llc - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - ropinirole tablets are indicated for the treatment of parkinson’s disease. ropinirole tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. there are no adequate and well-controlled studies in pregnant women. in animal reproduction studies, ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects. ropinirole should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. oral treatment of pregnant rats with ropinirole during organogenesis resulted in decreased fetal body weight, increased fetal death, and digital malformations at 24, 36, and 60 times, respectively, the maximum recommended human dose (mrhd) for parkinson’s disease (24 mg/day) on a mg/m2 basis. the combined oral adm

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

golden state medical supply, inc. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - ropinirole tablets are indicated for the treatment of parkinson’s disease. ropinirole tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. there are no adequate data on the developmental risk associated with the use of ropinirole tablets in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at > 36 times) the mrhd for parkinson’s disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of l-dopa when these drugs were administered in combination [see

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

dr. reddys laboratories limited - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 2 mg - ropinirole extended-release tablets are indicated for the treatment of parkinson’s disease. ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of ropinirole extended-release tablets in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the mrhd for parkinson’s disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of l-dopa when these drugs were administered in combination [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 in the indicated populations is unknown.   data animal data: oral administration of ropinirole (0, 20, 60, 90, 120, or 150 mg/kg/day) to pregnant rats during organogenesis resulted in embryolethality, increased incidence of fetal malformations (digit, cardiovascular, and neural tube defects) and variations, and decreased fetal weight at the 2 highest doses. these doses were also associated with maternal toxicity. the highest no-effect dose for adverse effects on embryofetal development (90 mg/kg/day) is approximately 36 times the mrhd for parkinson’s disease (24 mg/day) on a body surface area (mg/m2 ) basis.   no effect on embryofetal development was observed in rabbits when ropinirole was administered alone during organogenesis at oral doses of 0, 1, 5, or 20 mg/kg/day (up to 16 times the mrhd on a mg/m2  basis). in pregnant rabbits, there was a greater incidence and severity of fetal malformations (primarily digit defects) when ropinirole (10 mg/kg/day) was administered orally during gestation in combination with l-dopa (250 mg/kg/day) than when l-dopa was administered alone. this drug combination was also associated with maternal toxicity.   oral administration of ropinirole (0, 0.1, 1, or 10 mg/kg/day) to rats during late gestation and continuing throughout lactation resulted in neurobehavioral impairment (decreased startle response) and decreased body weight in offspring at the highest dose. the no-effect dose of 1 mg/kg/day is less than the mrhd on a mg/m2 basis. risk summary there are no data on the presence of ropinirole in human milk, the effects of ropinirole on the breastfed infant, or the effects of ropinirole on milk production. however, inhibition of lactation is expected because ropinirole inhibits secretion of prolactin in humans. ropinirole or metabolites, or both, are present in rat milk.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ropinirole extended-release tablets and any potential adverse effects on the breastfed infant from ropinirole or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. dose adjustment is not necessary in elderly (65 years and older) patients, as the dose of ropinirole extended-release tablets is individually titrated to clinical therapeutic response and tolerability. pharmacokinetic trials conducted in patients demonstrated that oral clearance of ropinirole is reduced by 15% in patients older than 65 years compared with younger patients [see clinical pharmacology (12.3) ]. in flexible-dose clinical trials of ropinirole extended-release, 387 patients were 65 years and older and 107 patients were 75 years and older. among patients receiving ropinirole extended-release, hallucination was more common in elderly patients (10%) compared with non-elderly patients (2%). in these trials, the incidence of overall adverse reactions increased with increasing age for both patients receiving ropinirole extended-release and placebo. in the fixed-dose clinical trials of ropinirole extended-release, 176 patients were 65 years and older and 73 were 75 and older. among patients with advanced parkinson’s disease receiving ropinirole extended-release, vomiting and nausea were more common in patients greater than 65 years (5% and 9%, respectively) compared with patients less than 65 (1% and 7%, respectively). no dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 ml/min). for patients with end-stage renal disease on hemodialysis, a reduced maximum dose is recommended [see dosage and administration (2.2), clinical pharmacology (12.3) ]. the use of ropinirole extended-release tablets in patients with severe renal impairment (creatinine clearance <30 ml/min) without regular dialysis has not been studied. the pharmacokinetics of ropinirole have not been studied in patients with hepatic impairment. 

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

zydus pharmaceuticals (usa) inc. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - ropinirole hydrochloride tablets are indicated for the treatment of parkinson's disease. ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). ropinirole hydrochloride tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of ropinirole in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the maximum recommended human dose (mrhd) for parkinson's disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of

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

solco healthcare us, llc - ropinirole (unii: 030pyr8953) (ropinirole - unii:030pyr8953) - ropinirole extended-release tablets are indicated for the treatment of parkinson’s disease. ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of ropinirole extended-release tablets in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the mrhd for parkinson’s disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of l-dopa when these drugs were administered in combination [see data] . in the u.s. general population, the estimated background ris

Израел - Енглески - Ministry of Health

glaxo smith kline (israel) ltd - ropinirole as hydrochloride - film coated tablets - prolonged release - ropinirole as hydrochloride 2 mg - ropinirole - ropinirole - treatment of parkinson’s disease under the following conditions:• initial treatment as monotherapy, in order to delay the introduction of levodopa• in combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur (“end of dose” or “on-off” type fluctuations)."