Tanzania - English - Tanzania Medicinces & Medical Devices Authority

sun pharmaceutical industries limited, india - emtricitabine , tenofovir disoproxil fumarate - tablet, film-coated - 200/300

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - atosiban (as acetate) - premature birth - other gynecologicals - atosiban is indicated to delay imminent pre-term birth in pregnant adult women with:regular uterine contractions of at least 30 seconds’ duration at a rate of ≥ 4 per 30 minutes;a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%;a gestational age from 24 until 33 completed weeks;a normal foetal heart rate.

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

sun pharmaceutical industries limited - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 600 mg - postherpetic neuralgia gabapentin tablets, usp are indicated for the management of postherpetic neuralgia in adults. epilepsy gabapentin tablets, usp are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. gabapentin tablets are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. gabapentin tablets, usp are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. gabapentin is not a scheduled drug. gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. a small number of postmarketing cases report gabapentin misuse and abuse. these individuals were taking higher than recommended doses of gabapentin for unapproved uses. most of the individuals described in these reports had a history of poly-substance abuse or used gabapentin to relieve sym

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

sun pharmaceutical industries limited, india - divalproex sodium - tablets - 250 mg

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

sun pharmaceutical industries limited, india - divalproex sodium - tablets - 500 mg

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

sun pharmaceutical industries limited, india - divalproex sodium - tablets - 250 mg

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - capecitabine - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - capecitabine - capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine is indicated for the treatment of metastatic colorectal cancer.capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline. capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

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

sun pharmaceutical industries, inc. - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - amphetamine sulfate tablets, usp are indicated for: - narcolepsy - attention deficit-disorder with hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. the diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. - exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. the limited usefulness of amphetamines (see clinical pharmacology) should be weighed against possible risks inherent in use of the drug, such as those described below. - known hypersensitivity to amphetamine products. - during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). controlled substance amphetamine sulfate tablets contains amphetamine, a schedule ii controlled substance. abuse amphetamine sulfate tablets has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warnings). amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including amphetamine sulfate, can result in overdose and death (see overdosage), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. dependence physical dependence amphetamine sulfate tablets may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including amphetamine sulfate tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance amphetamine sulfate tablets may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i.e. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control.as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

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

sun pharmaceutical industries, inc. - sonidegib phosphate (unii: w421ai34uw) (sonidegib - unii:0rlu3vtk5m) - sonidegib 200 mg - odomzo (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (bcc) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. none. risk summary based on its mechanism of action and data from animal reproduction studies, odomzo can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ]. there are no available data on the use of odomzo in pregnant women. in animal reproduction studies, oral administration of sonidegib during organogenesis at doses below the recommended human dose of 200 mg resulted in embryotoxicity, fetotoxicity, and teratogenicity in rabbits (see data). teratogenic effects observed included severe midline defects, missing digits, and other irreversible malformations. advise pregnant women of the potential risk to a fetus. report pregnancies to sun pharmaceutical industries, inc. at 1-800-406-7984. in the u.s. general population, the estimated background risk of major birth defects is 2-4% and of miscarriage in clinically recognized pregnancies is 15-20%. data animal data daily oral administration of sonidegib to pregnant rabbits resulted in abortion, complete resorption of fetuses, or severe malformations at ≥ 5 mg/kg/day (approximately 0.05 times the recommended human dose based on auc). teratogenic effects included vertebral, distal limb and digit malformations, severe craniofacial malformations, and other severe midline defects. skeletal variations were observed when maternal exposure to sonidegib was below the limit of detection. no data are available regarding the presence of sonidegib in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with odomzo and for 20 months after the last dose. based on its mechanism of action and animal data, odomzo can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1) ] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating odomzo treatment. contraception females advise females of reproductive potential to use effective contraception during treatment with odomzo and for at least 20 months after the last dose. males it is not known if sonidegib is present in semen. advise male patients to use condoms, even after a vasectomy, to avoid potential drug exposure to pregnant partners and female partners of reproductive potential during treatment with odomzo and for at least 8 months after the last dose. advise males not to donate semen during treatment with odomzo and for at least 8 months after the last dose. infertility based on findings from animal studies, female fertility may be compromised with odomzo [see nonclinical toxicology (13.1) ] . the safety and effectiveness of odomzo have not been established in pediatric patients. epiphyseal disorders, including premature fusion of the epiphyses, have been reported in pediatric patients exposed to odomzo in a clinical trial. in some cases, pediatric patients treated with other hh pathway inhibitors have experienced progression of epiphyseal fusion despite discontinuation of the hh pathway inhibitor. juvenile animal data in a 5-week juvenile rat toxicology study, effects of sonidegib were observed in bone, teeth, reproductive tissues, and nerves at doses ≥10 mg/kg/day (approximately 1.2 times the recommended human dose based on auc). bone findings included thinning/closure of bone growth plate, decreased bone length and width, and hyperostosis. findings in teeth included missing or fractured teeth, and atrophy. reproductive tissue toxicity was evidenced by atrophy of testes, ovaries, and uterus, partial development of the prostate gland and seminal vesicles, and inflammation and aspermia of the epididymis. nerve degeneration was also noted. of the 229 patients who received odomzo (79 patients receiving 200 mg daily and 150 patients receiving 800 mg daily) in bolt, 54% were 65 years and older, while 28% were 75 years and older. no overall differences in effectiveness were observed between these patients and younger patients. there was a higher incidence of serious adverse reactions, grade 3 and 4 adverse reactions, and adverse reactions requiring dose interruption or discontinuation in patients ≥65 years compared with younger patients; this was not attributable to an increase in any specific adverse event.