Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - ropinirole hydrochloride - oral tablet - 5mg

Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - ropinirole hydrochloride - oral tablet - 5mg

Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

phoenix healthcare distribution ltd - ropinirole hydrochloride - oral tablet - 5mg

Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - ropinirole hydrochloride - oral tablet - 5mg

Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

waymade healthcare plc - ropinirole hydrochloride - oral tablet - 5mg

Spojené štáty - angličtina - NLM (National Library of Medicine)

deseret biologicals, inc. - taraxacum officinale (unii: 39981fm375) (taraxacum officinale - unii:39981fm375), goldenseal (unii: zw3z11d0jv) (goldenseal - unii:zw3z11d0jv), melatonin (unii: jl5dk93rcl) (melatonin - unii:jl5dk93rcl), dopamine hydrochloride (unii: 7l3e358n9l) (dopamine - unii:vtd58h1z2x), levodopa (unii: 46627o600j) (levodopa - unii:46627o600j), serotonin hydrochloride (unii: gkn429m9vs) (serotonin - unii:333do1rdjy) - dopamine hydrochloride – brain fatigue, travel sickness, hydrastis canadensis – brain fog, l-dopa – poor concentration, melatonin – jet lag, serotonin (hydrochloride) – anxiety, stress, taraxacum officinale – mood swings • for the temporary relief of symptoms including: • brain fatigue • brain fog • anxiety • poor concentration • jet lag • mood swings • stress • travel sickness these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration.

Spojené štáty - angličtina - NLM (National Library of Medicine)

deseret biologicals, inc. - chaste tree fruit (unii: 433osf3u8a) (chaste tree - unii:433osf3u8a), ambergris (unii: xtc0d02p6c) (ambergris - unii:xtc0d02p6c), petroselinum crispum whole (unii: 1wza4y92ex) (petroselinum crispum - unii:1wza4y92ex), estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), levodopa (unii: 46627o600j) (levodopa - unii:46627o600j), melatonin (unii: jl5dk93rcl) (melatonin - unii:jl5dk93rcl), testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o), adenosine triphosphate disodium (unii: 5l51b4dr1g) (adenosine triphosphate - unii:8l70q75fxe), alpha lipoic acid (unii: 73y7p0k73y) (.alpha.-lipoic acid - unii:73y7p0k73y), nadide (unii: 0u46u6e8uk) (nadide - unii:0u46u6e8uk), pantothenic acid (unii: 19f5hk2737) (pantothenic acid - unii:19f5hk2737), lactic acid, l- (unii: f9s9ffu82n) (lactic acid, l- - unii:f9s9ffu82n), ubidecarenone (unii: ej27x76m46) (ubidecarenone - unii:ej27x76m46), barium carbonate (unii: 6p669d8hq8) (barium cation - unii:v645272hln), conium maculatum flowering top (unii: q28r5gf371) (conium maculatum flowering top - unii:q28r5gf371), selenium (unii: h6241uj22b) (selenium - unii:h6241uj22b), estrone (unii: 2di9ha706a) (estrone - unii:2di9ha706a), sus scrofa umbilical cord (unii: 118oyg6w3h) (sus scrofa umbilical cord - unii:118oyg6w3h), .gamma.-aminobutyric acid (unii: 2acz6ipc6i) (.gamma.-aminobutyric acid - unii:2acz6ipc6i), sus scrofa adrenal gland (unii: 398iyq16yv) (sus scrofa adrenal gland - unii:398iyq16yv), pork liver (unii: 6ec706hi7f) (pork liver - unii:6ec706hi7f), sus scrofa hypothalamus (unii: n6r0856z79) (sus scrofa hypothalamus - unii:n6r0856z79), sus scrofa lymph (unii: 33a7vyu29l) (sus scrofa lymph - unii:33a7vyu29l), sus scrofa bone marrow (unii: vp2cn2g7y8) (sus scrofa bone marrow - unii:vp2cn2g7y8), sus scrofa ovary (unii: s7ytv04r8o) (sus scrofa ovary - unii:s7ytv04r8o), sus scrofa testicle (unii: km02613o28) (sus scrofa testicle - unii:km02613o28), sus scrofa pancreas (unii: 9y3j3362ry) (sus scrofa pancreas - unii:9y3j3362ry), sus scrofa spleen (unii: 92amn5j79y) (sus scrofa spleen - unii:92amn5j79y), sus scrofa pituitary gland (unii: l0pfemq1dt) (sus scrofa pituitary gland - unii:l0pfemq1dt), apiole (parsley) (unii: qq67504pxo) (apiole (parsley) - unii:qq67504pxo), proteus morganii (unii: 56x6lid5zy) (proteus morganii - unii:56x6lid5zy) - adenosinum triphosphoricum dinatrum - fatigue, agnus castus - fatigue, alpha-lipoicum acidum – joint pain, ambra grisea – muscle soreness, apiolum – joint pain, baryta carbonica – joint pain, conium maculatum – muscle soreness, estradiol - fatigue, folliculinum – muscle soreness, funiculus umbilicalis suis – muscle soreness, gaba (gamma-aminobutyric acid) - fatigue, glandula suprarenalis suis - fatigue, hepar suis – joint pain, hypothalamus suis - fatigue, l-dopa – joint pain, lymph node (suis) - fatigue, medulla ossis suis – joint pain, melatonin – joint pain, nadidum - fatigue, oophorinum (suis) - fatigue, orchitinum (suis)- fatigue, pancreas suis – muscle soreness, pantothenic acid - fatigue, petroselinum sativum – joint pain, pituitary gland anterior (suis) – muscle soreness, proteus (morgani) – joint pain, sarcolacticum acidum – muscle soreness, selenium metallicum - fatigue, spleen (suis) - fatigue, testosterone – muscle soreness, ubidecarenonum – joint pain • for the temporary relief of symptoms including: • fatigue • joint pain • muscle soreness these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration.

Spojené štáty - angličtina - 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. 

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

apotex nz ltd - ropinirole hydrochloride 0.285mg equivalent to to 0.25 mg ropinirole - film coated tablet - 0.25 mg - active: ropinirole hydrochloride 0.285mg equivalent to to 0.25 mg ropinirole excipient: citric acid hyprolose hypromellose 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.

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

apotex nz ltd - ropinirole hydrochloride 0.57mg equivalent to to 0.5 mg ropinirole - film coated tablet - 0.5 mg - active: ropinirole hydrochloride 0.57mg equivalent to to 0.5 mg ropinirole excipient: citric acid hyprolose hypromellose iron oxide yellow 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.