Kenya - engelsk - Pharmacy and Poisons Board

msn laboratories private limited msn house, plot no.c-24, industrial estate, - pantoprazole - injection - 40mg/vial - pantoprazole

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private limited - thiotepa (unii: 905z5w3gkh) (thiotepa - unii:905z5w3gkh) - thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder. pediatric use information is approved for adienne sa 's tepadina (thiotepa) for injection. however, due to adienne sa 's marketing exclusivity rights, the drug product is not labeled with that information. thiotepa for injection is contraindicated in: - patients with severe hypersensitivity to thiotepa [see warnings and precautions (5.2)] - concomitant use with live or attenuated vaccines [see warnings and precautions (5.4)] risk summary thiotepa can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [see clinical pharmacology (12.1)] . limited available data with thiotepa use in pr

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private limited - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, taenia solium . albendazole tablets are indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, echinococcus granulosus . albendazole is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole. risk summary based on findings from animal reproduction studies, albendazole may cause fetal harm when administered to a pregnant woman. however, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reprod

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private limited - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.   febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). no adve

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private limited - fosaprepitant dimeglumine (unii: d35fm8t64x) (aprepitant - unii:1nf15yr6uy) - fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin. • delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). limitations of use • fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting. pediatric use information is approved for merck sharp & dohme corp., a subsidiary of merck & co., inc.’s emend (fosaprepitant) for injection. however, due to merck sharp & dohme corp., a subsidiary of merck & co., inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. fosaprepitant is contraindicated in patients: -  who are hypersensitive to any component of the product. hypersensitivity reactions  including  anaphylactic reactio

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private limited - droxidopa (unii: j7a92w69l7) (droxidopa - unii:j7a92w69l7) - droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (noh) caused by primary autonomic failure (parkinson's disease [pd], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. effectiveness beyond 2 weeks of treatment has not been established. the continued effectiveness of droxidopa capsules should be assessed periodically. droxidopa is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [ see warnings and precautions (5.4)]. risk summary there are no available data on use of droxidopa in pregnant women and risk of major birth defects or miscarriage. droxidopa did not produce significant reproductive toxicity in pregnant female rats or rabbits or in their fetuses. however, when pregnant female rats were dosed during days 7-17

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private limited - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with • metastatic castration-resistant prostate cancer (crpc) • metastatic high-risk castration-sensitive prostate cancer (cspc) none. risk summary the safety and efficacy of abiraterone acetate have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate can cause fetal harm and potential loss of pregnancy. there are no human data on the use of abiraterone acetate in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data). data animal data in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private limited - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablet is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate is contraindicated in patients: - with urinary retention [see warnings and precautions (5.2)] , - with gastric retention [see warnings and precautions (5.3)] , - with uncontrolled narrow-angle glaucoma [see warnings and precautions (5.5)] , and - who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions (6.2)] . risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during th

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private 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. deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox is 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 maligna

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private limited - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate delayed-release capsules are 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. dimethyl fumarate is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)]. risk summary there are no adequate data on the developmental risk associated with the use of dimethyl fumarate in pregnant women. in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (dmf) was administered during pregnancy and lactation at clinically relevant doses. [see data]  in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respecti