Malta - angļu - Medicines Authority

holsten pharma gmbh hahnstraße 31-35 60528 frankfurt am main , germany - prucalopride succinate - film-coated tablet - prucalopride succinate 2 mg - drugs for constipation

Eiropas Savienība - angļu - EMA (European Medicines Agency)

accord healthcare s.l.u. - fampridine - multiple sclerosis - other nervous system drugs - fampridine accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7). 

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

acorda therapeutics, inc. - dalfampridine (unii: bh3b64okl9) (dalfampridine - unii:bh3b64okl9) - dalfampridine 10 mg - ampyra is indicated as a treatment to improve walking in adult patients with multiple sclerosis (ms). this was demonstrated by an increase in walking speed [see clinical studies (14)]. the use of ampyra is contraindicated in the following conditions: - history of seizure [ see warnings and precautions (5.1)] - moderate or severe renal impairment (crcl≤50 ml/min) [see warnings and precautions (5.2) ] - history of hypersensitivity to ampyra or 4-aminopyridine; reactions have included anaphylaxis [see warnings and precautions (5.4) ] risk summary there are no adequate data on the developmental risk associated with use of ampyra in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see data ]. in the u.s. general population, the estimated background risk of major birth defects and 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 dalfampridine to pregnant rats and rabbits throughout organogenesis resulted in no evidence of developmental toxicity in either species. the highest doses tested (10 mg/kg/day in rats, 5 mg/kg/day in rabbits), which were associated with maternal toxicity, are approximately 5 times the mrhd on a body surface area (mg/m 2 ) basis. oral administration of dalfampridine (0, 1, 3, and 9 to 6 mg/kg/day; high dose reduced during the second week of dosing) to female rats throughout pregnancy and lactation resulted in decreased offspring viability at the highest dose tested and decreased body weight in offspring at the mid and high doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (1 mg/kg/day) is less than the mrhd on a mg/m 2 basis. risk summary there are no data on the presence of dalfampridine in human milk, the effects of dalfampridine on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ampyra and any potential adverse effects on the breastfed infant from ampyra or from the underlying maternal condition. safety and effectiveness in patients younger than 18 years of age have not been established. clinical studies of ampyra did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. a population pk analysis showed that dalfampridine clearance modestly decreased with increasing age, but not sufficiently to necessitate a modification of dose with age. other reported clinical experience has identified no differences in responses between the elderly and younger patients. ampyra is known to be substantially excreted by the kidneys and the risk of adverse reactions, including seizures, is greater with increasing exposure of dalfampridine. because elderly patients are more likely to have decreased renal function, it is particularly important to know the estimated creatinine clearance (crcl) in these patients [see warnings and precautions (5.2)]. clearance of dalfampridine is decreased in patients with renal impairment and is significantly correlated with creatinine clearance (crcl) [see clinical pharmacology (12.3)] . ampyra is contraindicated in patients with moderate or severe renal impairment (crcl ≤50 ml/min) [see contraindications (4)]. the risk of seizures in patients with mild renal impairment (crcl 51–80 ml/min) is unknown, but dalfampridine plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures. if unknown, estimated creatinine clearance should be calculated prior to initiating treatment with ampyra [see dosage and administration (2.3) and warnings and precautions (5.2)] .

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - prucalopride succinate, quantity: 1.321 mg (equivalent: prucalopride, qty 1 mg) - tablet - excipient ingredients: titanium dioxide; lactose monohydrate; macrogol 400; colloidal anhydrous silica; magnesium stearate; hypromellose; polysorbate 80; microcrystalline cellulose - prucalopride is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.,? before prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation.,? if treatment with prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - prucalopride succinate, quantity: 2.642 mg (equivalent: prucalopride, qty 2 mg) - tablet - excipient ingredients: microcrystalline cellulose; titanium dioxide; macrogol 400; colloidal anhydrous silica; lactose monohydrate; iron oxide red; hypromellose; magnesium stearate; polysorbate 80 - prucalopride is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.,? before prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation.,? if treatment with prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - prucalopride succinate, quantity: 1.321 mg (equivalent: prucalopride, qty 1 mg) - tablet - excipient ingredients: hypromellose; lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica; polysorbate 80; macrogol 400; titanium dioxide; magnesium stearate - prucalopride is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.,? before prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation.,? if treatment with prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - prucalopride succinate, quantity: 2.642 mg (equivalent: prucalopride, qty 2 mg) - tablet - excipient ingredients: microcrystalline cellulose; iron oxide red; hypromellose; polysorbate 80; lactose monohydrate; macrogol 400; titanium dioxide; magnesium stearate; colloidal anhydrous silica - prucalopride is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.,? before prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation.,? if treatment with prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

medtas pty ltd - prucalopride succinate, quantity: 2.64 mg (equivalent: prucalopride, qty 2 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; triacetin; iron oxide yellow; iron oxide red; macrogol 3000; indigo carmine aluminium lake - prucalopride is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief. ? before prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation. ? if treatment with prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

medtas pty ltd - prucalopride succinate, quantity: 1.32 mg (equivalent: prucalopride, qty 1 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; triacetin; macrogol 3000 - prucalopride is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief. ? before prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation. ? if treatment with prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

Austrālija - angļu - APVMA (Australian Pesticides and Veterinary Medicines Authority)

amgrow pty ltd - imidacloprid - suspension concentrate - imidacloprid guanidine active 200.0 g/l - insecticide - azalea - in pot | duboisia or corkwood | elm tree | eucalyptus seedling | ornamental plant | ornamentals in pots | pandanus tree - african black beetle - 1st instar larvae | aphid | argentinian scarab - first instar larvae | azalea lace bug | bill bug - larvae | bronze orange bug | chrysomelid beetle | citrus mealy bug | elm leaf beetle | flatid | fuller's rose weevil | green peach aphid | greenhouse thrip | harlequin bug | hibiscus flower beetle | longtailed mealy bug | pruinose scarab - first instar larvae | psyllid or lerp insect | scarab beetle - larva | soft scale | billbug | elm tree leaf beetle | la plata weevil | pandanus planthopper