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

cerner corporation pty ltd - 58842 - pharmaceutical information system application software - an application , routine, and/or algorithm intended for use as or in an information system to receive, collect, store, manage,assist in analysis of, display, output and distribute data within or between healthcare facilities, to assist with therapeutic pharmaceutical prescription and management

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - oxcarbazepine (unii: vzi5b1w380) (oxcarbazepine - unii:vzi5b1w380) - oxcarbazepine 150 mg - trileptal 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. trileptal 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 trileptal, during pregnancy. encourage women who are taking trileptal 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 the use of trileptal in pregnant women; however, trileptal is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. data on a limited number of pregnancies from pregnancy registries suggest that trileptal monotherapy use is associated with congenital malformations (e.g., craniofacial defects, such as oral clefts, and cardiac malformations, such as ventricular septal defects). increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (mhd) during pregnancy at doses similar to the maximum recommended human dose (mrhd). 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. clinical considerations an increase in seizure frequency may occur during pregnancy because of altered levels of the active metabolite of oxcarbazepine. monitor patients carefully during pregnancy and through the postpartum period [see warnings and precautions (5.10)] . data human data data from published registries have reported craniofacial defects, such as oral clefts and cardiac malformations, such as ventricular septal defects in children with prenatal oxcarbazepine exposure. animal data when pregnant rats were given oxcarbazepine (0, 30, 300, or 1000 mg/kg/day) orally throughout the period of organogenesis, increased incidences of fetal malformations (craniofacial, cardiovascular, and skeletal) and variations were observed at the intermediate and high doses (approximately 1.2 and 4 times, respectively, the mrhd on a mg/m2 basis). increased embryofetal death and decreased fetal body weights were seen at the high dose. doses ≥300 mg/kg/day were also maternally toxic (decreased body weight gain, clinical signs), but there is no evidence to suggest that teratogenicity was secondary to the maternal effects. in a study in which pregnant rabbits were orally administered mhd (0, 20, 100, or 200 mg/kg/day) during organogenesis, embryofetal mortality was increased at the highest dose (1.5 times the mrhd on a mg/m2 basis). this dose produced only minimal maternal toxicity. in a study in which female rats were dosed orally with oxcarbazepine (0, 25, 50, or 150 mg/kg/day) during the latter part of gestation and throughout the lactation period, a persistent reduction in body weights and altered behavior (decreased activity) were observed in offspring exposed to the highest dose (less than the mrhd on a mg/m2 basis). oral administration of mhd (0, 25, 75, or 250 mg/kg/day) to rats during gestation and lactation resulted in a persistent reduction in offspring weights at the highest dose (equivalent to the mrhd on a mg/m2 basis). risk summary oxcarbazepine and its active metabolite (mhd) are present in human milk after trileptal administration. the effects of oxcarbazepine and its active metabolite (mhd) on the breastfed infant or on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for trileptal and any potential adverse effects on the breastfed infant from trileptal or from the underlying maternal condition. contraception use of trileptal with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with decreased plasma concentrations of these hormones and may result in a failure of the therapeutic effect of the oral contraceptive drug. advise women of reproductive potential taking trileptal who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see drug interactions (7.3) and clinical pharmacology (12.3)] . trileptal is indicated for use as adjunctive therapy for partial-onset seizures in patients aged 2 to 16 years. the safety and effectiveness for use as adjunctive therapy for partial-onset seizures in pediatric patients below the age of 2 have not been established. trileptal is also indicated as monotherapy for partial-onset seizures in patients aged 4 to 16 years. the safety and effectiveness for use as monotherapy for partial-onset seizures in pediatric patients below the age of 4 have not been established. trileptal has been given to 898 patients between the ages of 1 month to 17 years in controlled clinical trials (332 treated as monotherapy) and about 677 patients between the ages of 1 month to 17 years in other trials [s ee warnings and precautions (5.11), adverse reactions (6.1) , clinical pharmacology (12.3), and clinical studies (14 ) ]. there were 52 patients over age 65 in controlled clinical trials and 565 patients over the age of 65 in other trials. following administration of single (300 mg) and multiple (600 mg/day) doses of trileptal in elderly volunteers (60 to 82 years of age), the maximum plasma concentrations and area under the curve (auc) values of mhd were 30% to 60% higher than in younger volunteers (18 to 32 years of age). comparisons of creatinine clearance in young and elderly volunteers indicate that the difference was due to age-related reductions in creatinine clearance. close monitoring of sodium levels is required in elderly patients at risk for hyponatremia [see warnings and precautions (5.1) ]. dose adjustment is recommended for renally impaired patients (creatinine clearance < 30 ml/min) [see dosage and administration (2. 7 ) and clinical pharmacology (12.3) ]. the abuse potential of trileptal has not been evaluated in human studies. intragastric injections of oxcarbazepine to 4 cynomolgus monkeys demonstrated no signs of physical dependence as measured by the desire to self-administer oxcarbazepine by lever pressing activity. trileptal® (oxcarbazepine) oral suspension           300 mg/5 ml each 5 ml contains 300 mg oxcarbazepine instructions for use read these instructions carefully to learn how to use the medicine dispensing system correctly. distributed by: novartis pharmaceuticals corporation east hanover, new jersey 07936 march 2018 t2018-33 © novartis

Philippines - English - FDA (Food And Drug Administration)

akums drugs & pharmaceuticals ltd. (plant iii-injectables) - drug - metronidazole - promeddazole

Philippines - English - FDA (Food And Drug Administration)

patriot pharmaceuticals corporation; distributor: patriot pharmaceuticals corporation - memantine hc1 - film-coated tablet - 10mg

United States - English - NLM (National Library of Medicine)

first horizon pharmaceutical corporation - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - spray - 400 ug - nitrolingual® pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. allergic reactions to organic nitrates are rare.  nitroglycerin is contraindicated in patients who are allergic to it.  nitrolingual® pumpspray is contraindicated in patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), as their concomitant use can cause severe hypotension.  the time course and dose-dependency of this interaction are not known. safety and effectiveness of nitroglycerin in pediatric patients have not been established.

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - indacaterol maleate (unii: 2jec1itx7r) (indacaterol - unii:8or09251mq), glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - indacaterol 27.5 ug - utibrontm neohaler® is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. important limitations of use: utibron neohaler is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see warnings and precautions (5.1, 5.2)] . all labas are contraindicated in patients with asthma without use of a long-term asthma control medication [see warnings and precautions (5.1)] . utibron neohaler is not indicated for the treatment of asthma. utibron neohaler is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients [see warnings and precautions (5.5)] . teratogenic effects: pregnancy category c there are no adequate and well-controlled studies with utibron neohaler or its individual components, indacaterol and glycopyrrolate, in pregnant women

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. additional pediatric use information is approved for novartis pharmaceuticals corporation’s exjade® (deferasirox) tablets for oral suspension. however, due to novartis pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. the safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established. deferasirox tablets for oral suspension are contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; - poor performance status; [see warnings and precautions (5.1, 5.3)] - high-risk myelodysplastic syndromes; (this patient population was not studied and is not expected to benefit from chelatio

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. additional pediatric use information is approved for novartis pharmaceuticals corporation’s jadenu® (deferasirox) tablets. however, due to novartis pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox tablets are contraindicated in patients with: • estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; • poor performance status [see warnings and precautions (5.1, 5.3)]; • high-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); • advanced malignancies [see warnings and precautions (5

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - canakinumab (unii: 37cq2c7x93) (canakinumab - unii:37cq2c7x93) - canakinumab 150 mg in 1 ml - ilaris® (canakinumab) is an interleukin-1β (il-1β) blocker indicated for the treatment of the following autoinflammatory periodic fever syndromes: cryopyrin-associated periodic syndromes (caps) ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps), in adults and pediatric patients 4 years of age and older, including: - familial cold autoinflammatory syndrome (fcas) - muckle-wells syndrome (mws) tumor necrosis factor receptor (tnf) associated periodic syndrome (traps) ilaris is indicated for the treatment of tumor necrosis factor (tnf) receptor associated periodic syndrome (traps) in adult and pediatric patients. hyperimmunoglobulin d syndrome (hids)/mevalonate kinase deficiency (mkd) ilaris is indicated for the treatment of hyperimmunoglobulin d (hyper-igd) syndrome (hids)/mevalonate kinase deficiency (mkd) in adult and pediatric patients. familial mediterranean fever (fmf) ilaris is indicated for the treatment of familial mediterranean fever (fmf) in adult and pediatric pat

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - interferon beta-1b (unii: ttd90r31wz) (interferon beta-1b - unii:ttd90r31wz) - interferon beta-1b 0.25 mg in 1.0 ml - extavia is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. extavia is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. risk summary although there have been no well-controlled studies in pregnant women, available data, which include prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. administration of interferon beta-1b to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose (see animal 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%, respective