Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

pharmaceutical associates, inc. - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate oral suspension, usp is not indicated as a first line antiepileptic treatment (see warnings ). felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbamate oral suspension, usp is contraindicated in patients with known hypersensitivity to felbamate oral suspension, its ingredients, or known sensitivity to other carbamates. it should not be use

Canada - engleză - Health Canada

novartis pharmaceuticals canada inc - oxcarbazepine - suspension - 60mg - oxcarbazepine 60mg - miscellaneous anticonvulsants

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

aurobindo pharma limited - nevirapine hemihydrate (unii: b7xf2td73c) (nevirapine - unii:99dk7fvk1h) - nevirapine 50 mg in 5 ml - nevirapine oral suspension is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine oral suspension is not recommended to be initiated, unless the benefit outweighs the risk, in: - adult females with cd4+ cell counts greater than 250 cells/mm3 or - adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. nevirapine oral suspension is contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1)  and use in specific populations (8.7) ]. - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)]. pregnancy exp

Regatul Unit - engleză - MHRA (Medicines & Healthcare Products Regulatory Agency)

reckitt benckiser healthcare (uk) ltd - calcium carbonate; sodium bicarbonate; sodium alginate - oral suspension - 32.5mg/1ml ; 21.3mg/1ml ; 50mg/1ml

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bionpharma inc. - rufinamide (unii: wfw942pr79) (rufinamide - unii:wfw942pr79) - rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with lennox-gastaut syndrome in pediatric patients 1 year of age and older and in adults. rufinamide is contraindicated in patients with familial short qt syndrome [ see  warnings and precautions  ( 5.3 ) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as rufinamide, during pregnancy. encourage women who are taking rufinamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no adequate data on the developmental risks associated with use of rufinamide in pregnant women. in animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see data] . in the u.s. general population, the estimated b

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6)] . pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8)  and clinical considerations ] . availab

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

lannett company, inc. - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6 )] . pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. physicians are advised to recommend that pregnant patients taking clobazam 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 there are no adequate and well-controlled studies of clobazam in pregnant women. available data suggest that the class o

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6)]. pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam oral suspension enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8) and clinical consideration

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine is indicated in adults for the treatment of: - major depressive disorder (mdd) - obsessive compulsive disorder (ocd) - panic disorder (pd) - social anxiety disorder (sad) - generalized anxiety disorder (gad) - posttraumatic stress disorder (ptsd) paroxetine is contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions ( 7)]. - taking thioridazine because of risk of qt prolongation [see warnings and precautions (5. 3) and drug interactions (7)] - taking pimozide because of risk of qt prolongation [see warnings and precautions (5.3), drug interactions (7)]. - with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine oral suspension [see adverse reactions (6.1), (6.2)] . risk summary based on data from published observational stu

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

glasshouse pharmaceuticals limited canada - oxcarbazepine (unii: vzi5b1w380) (oxcarbazepine - unii:vzi5b1w380) - oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. oxcarbazepine is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [ see warnings and precautions (5.2, 5.3) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as oxcarbazepine, during pregnancy. encourage women who are taking oxcarbazepine during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the dev