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.

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.

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.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - levetiracetam - epilepsy - other antiepileptics - levetiracetam sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.levetiracetam sun is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.levetiracetam sun concentrate is an alternative for patients when oral administration is temporarily not feasible.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries (europe) b.v. - ertapenem sodium - bacterial infections - ertapenem - treatmentertapenem sun is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1):- intra-abdominal infections- community acquired pneumonia- acute gynaecological infections- diabetic foot infections of the skin and soft tissue (see section 4.4)preventionertapenem sun is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatide - osteoporosis; osteoporosis, postmenopausal - calcium homeostasis - teriparatide sun is indicated in adults.treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated.treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.sitagliptin/metformin hydrochloride sun is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.sitagliptin/metformin hydrochloride sun is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist.sitagliptin/metformin hydrochloride sun is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone 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.

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

sun pharmaceutical industries, inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 10 mg - major depressive disorder paroxetine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets, usp in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology–clinical trials). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets, usp in hospitalized depressed patients have not been adequ

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

sun pharmaceutical industries, inc. - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 7.5 mg - temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatal- postnatal study in rats, oral doses of 60 mg/kg/day resul