METFORMIN HYDROCHLORIDE tablet, film coated الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

metformin hydrochloride tablet, film coated

ingenus pharmaceuticals, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)]. - hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data ]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations ]. no adverse developmental effects were observe

CARBOPLATIN injection, solution الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

carboplatin injection, solution

ingenus pharmaceuticals, llc - carboplatin (unii: bg3f62ond5) (carboplatin - unii:bg3f62ond5) - carboplatin 50 mg in 5 ml - initial  treatment  of  advanced  ovarian  carcinoma carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. one established combination regimen consists of carboplatin and cyclophosphamide. two randomized controlled studies conducted by the ncic and swog with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see clinical studies). there is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup. secondary  treatment  of  advanced  ovarian  carcinoma carboplatin injection is indicated for the palliative treatment of patient