Amerika Serikat - Inggris - NLM (National Library of Medicine)

hospira, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 50 mg in 1 ml

Inggris - Inggris - MHRA (Medicines & Healthcare Products Regulatory Agency)

flynn pharma ltd - phenytoin sodium - oral capsule - 100mg

Armenia - Inggris - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

accord healthcare limited - etoposide - concentrate for solution for infusion - 20mg/ml

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

aft pharmaceuticals pty ltd - pregabalin, quantity: 20 mg/ml - oral liquid, solution - excipient ingredients: sucralose; monobasic sodium phosphate monohydrate; purified water; methyl hydroxybenzoate; dibasic sodium phosphate; flavour - pregabalin-aft is indicated for the treatment of neuropathic pain in adults.,pregabalin-aft is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Irlandia - Inggris - HPRA (Health Products Regulatory Authority)

lobsor pharmaceuticals ab - levodopa; carbidopa monohydrate; entacapone - intestinal gel - 20 mg/ml + 5 mg/ml + 20 milligram(s)/millilitre - levodopa, decarboxylase inhibitor and comt inhibitor

Amerika Serikat - Inggris - NLM (National Library of Medicine)

henry schein, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - parenteral phenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. parenteral phenytoin should be used only when oral phenytoin administration is not possible [see dosage and administration (2.1, 2.3) and warnings and precautions (5.1)] . phenytoin sodium injection is contraindicated in patients with: • a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . • sinus bradycardia, sino-atrial block, second and third degree a-v block, and adams-stokes syndrome because of the effect of parenteral phenytoin on ventricular automaticity. • a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.6)] . • coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. 8.1 pregnancy pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin sodium injection, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary in humans, prenatal exposure to phenytoin may increase the risk for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increased incidence of major malformations (including orofacial clefts and cardiac defects). in addition, the fetal hydantoin syndrome a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see data] . there have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment, and behavior abnormalities) in multiple species at clinically relevant doses [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 for the indicated population is unknown. clinical considerations disease-associated maternal risk an increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see dosage and administration (2.1, 2.7)] . however, postpartum restoration of the original dosage will probably be indicated. fetal/neonatal adverse reactions a potentially life-threatening bleeding disorder related to decreased levels of vitamin k-dependent clotting factors may occur in newborns exposed to phenytoin in utero . this drug-induced condition can be prevented with vitamin k administration to the mother before delivery and to the neonate after birth. data human data meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. an increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. the fetal hydantion syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digit hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. animal data administration of phenytoin to pregnant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth retardation. malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100, 75, and 12.5 mg/kg, respectively. 8.2 lactation risk summary phenytoin is secreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for phenytoin sodium injection and any potential adverse effects on the breastfed infant from phenytoin sodium injection or from the underlying maternal condition. 8.4 pediatric use a loading dose of 15 to 20 mg/kg of phenytoin sodium injection intravenously will usually produce serum concentrations of phenytoin within the generally accepted serum total concentrations between 10 to 20 mcg/ml (unbound phenytoin concentrations of 1 to 2 mcg/ml). because of the increased risk of adverse cardiovascular reactions associated with rapid administration phenytoin sodium injection should be injected slowly intravenously at a rate not exceeding 1 to 3 mg/kg/min or 50 mg per minute, whichever is slower [see dosage and administration (2.8) and warnings and precautions(5.1)] . 8.5 geriatric use phenytoin clearance tends to decrease with increasing age [see clinical pharmacology (12.3)] . lower or less frequent dosing may be required [see dosage and administration (2.6)] . 8.6 renal and/or hepatic impairment or hypoalbuminemia the liver is the site of biotransformation. patients with impaired liver function, elderly patients, or those who are gravely ill may show early toxicity. because of the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients.

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - pregabalin 20 mg/ml - oral solution - 20 mg/ml - active: pregabalin 20 mg/ml excipient: dibasic sodium phosphate methyl hydroxybenzoate monobasic sodium phosphate monohydrate purified water strawberry flavour #68998 (207420) sucralose - indicated for the treatment of neuropathic pain in adults.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

atlantic biologicals corps - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 125 mg in 5 ml - phenytoin oral suspension is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see and sections). dosage and administration clinical pharmacology phenytoin oral suspension is contraindicated in those patients with a history of hypersensitivity to phenytoin or other hydantoins. serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form. the free acid form of phenytoin is used in phenytoin oral suspension. because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa. dosage should be individualized to provide maximum benefit. in some cases serum b

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. extended phenytoin sodium capsules are contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . -  a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.6)] . - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as extended phenytoin sodium capsules, during pregnancy. physicians are advised to recommend that pregnant patients taking extended phenyto

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

novartis pharmaceuticals australia pty ltd - carbamazepine, quantity: 20 mg/ml - oral liquid, suspension - excipient ingredients: hyetellose; methyl hydroxybenzoate; purified water; dispersible cellulose; propyl hydroxybenzoate; sorbitol solution (70 per cent) (non-crystallising); peg-8 stearate; sorbic acid; propylene glycol; saccharin sodium; flavour - 1. epilepsy: complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalisation; generalised tonic-clonic seizures; mixed seizure patterns incorporating the above. tegretol is suitable for monotherapy and combination therapy. tegretol is usually not effective in absence seizures, atonic seizures and myoclonic seizures and should not be used for status epilepticus (see "precautions"). 2. trigeminal neuralgia: for relief of pain in idiopathic trigeminal neuralgia and trigeminal neuralgia due to multiple sclerosis; and in idiopathic glossopharyngeal neuralgia. (tegretol is not a simple analgesic and is not intended for trivial facial pain or headache). 3. mania and bipolar affective disorders: treatment of mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence.