Singapur - Englisch - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - (active layer) ropinirole hydrochloride eqv ropinirole - tablet, film coated, extended release - 2.28mg (equiv to 2mg ropinirole) - (active layer) ropinirole hydrochloride eqv ropinirole 2 mg

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

apotex corp. - 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 hydrochloride is 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 hydrochloride 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 l-dopa when these dr

Vereinigte Staaten - Englisch - 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

zydus lifesciences limited - 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

physicians total care, inc. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic parkinson's disease. the effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early parkinson's disease who were not receiving concomitant l-dopa therapy as well as in patients with advanced disease on concomitant l-dopa (see clinical pharmacology, clinical trials ). ropinirole hydrochloride 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

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ropinirole hydrochloride, quantity: 0.57 mg (equivalent: ropinirole, qty 0.5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - treatment of primary restless legs syndrome, including the reduction of associated periodic limb movement and episodes of nocturnal arousal.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ropinirole hydrochloride, quantity: 0.285 mg (equivalent: ropinirole, qty 0.25 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - treatment of primary restless legs syndrome, including the reduction of associated periodic limb movement and episodes of nocturnal arousal.

Vereinigte Staaten - Englisch - 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

Israel - Englisch - 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)."

Israel - Englisch - Ministry of Health

glaxo smith kline (israel) ltd - ropinirole as hydrochloride - film coated tablets - prolonged release - ropinirole as hydrochloride 4 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)."