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

calvin scott & co., inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - 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 m 2 ) [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 melli

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

remedyrepack inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine 8 mg - buprenorphine sublingual tablets is indicated for the treatment of opioid dependence and is preferred for induction. buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. buprenorphine sublingual tablets is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported. [see warnings and precautions ( 5.9)] . risk summary the data on use of buprenorphine, the active ingredient in buprenorphine sublingual tablets , in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see data] . observational studies have reported on congenital malformations among buprenorphine-exposed preg

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - botulinum toxin type a 100 units equivalent to incobotulinumtoxina (usan), purified botulinum toxin type a - powder for injection - 100 units - active: botulinum toxin type a 100 units equivalent to incobotulinumtoxina (usan), purified botulinum toxin type a excipient: albumin sucrose - xeomin is indicated in adults for the treatment of: · cervical dystonia · blepharospasm · spasticity of the upper limb · upper facial lines -glabellar frown lines -lateral periorbital lines (crow's feet) - horizontal forehead lines

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - botulinum toxin type a 50 units equivalent to incobotulinumtoxina (usan), purified botulinum toxin type a - powder for injection - 50 units - active: botulinum toxin type a 50 units equivalent to incobotulinumtoxina (usan), purified botulinum toxin type a excipient: albumin sucrose - xeomin is indicated in adults for the treatment of: · cervical dystonia · blepharospasm · spasticity of the upper limb · upper facial lines -glabellar frown lines -lateral periorbital lines (crow's feet) - horizontal forehead lines

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

preferred pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 10 mg in 1 g - diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. diclofenac sodium topical gel is contraindicated in the following patients: pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation risk summary use of nsaids, including diclofenac sodium topical gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including diclofenac sodium topical gel, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of diclofenac sodium topical gel in pregnant women. human and animal studies indicate that diclofenac crosses the placenta. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all cli

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

nucare pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 10 mg in 1 g - diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. - diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder. diclofenac sodium topical gel is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see  warnings and precautions ( 5.7, 5.9 )] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions ( 5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1 )] pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation risk summary use of nsaids, including diclofenac sodium t

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

teva pharmaceuticals usa, inc. - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole 200 mg - ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or candida infections. ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. coadministration of a number of cyp3a4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that

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

nucare pharmaceuticals,inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 10 mg in 1 g - diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. - diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder. diclofenac sodium topical gel is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see  warnings and precautions ( 5.7, 5.9 )] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions ( 5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1 )] pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation risk summary use of nsaids, including diclofenac sodium t

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

remedyrepack inc. - sitagliptin phosphate (unii: ts63ew8x6f) (sitagliptin - unii:qfp0p1dv7z), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - janumet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use janumet should not be used in patients with type 1 diabetes mellitus. janumet has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using janumet. [see warnings and precautions (5.2).] janumet is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m 2 ) [see warnings and precautions (5.1)] . - acute or chronic metabolic acidosis, including diabetic ketoacidosis. - history of a serious hypersensitivity reaction to janumet, sitagliptin, or metformin, such as anaphylaxis or angioedema. [see warnings and precautions (5.7); adverse reactions (6.2).] pregnanc

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

actavis pharma, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 16.05 mg in 1 ml - diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). diclofenac sodium is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. [see warnings and precautions ( 5.7 , 5.9 )] . - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7 , 5.8 )] . - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] . pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation risk summary use of nsaids, including diclofenac sodium, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including diclofenac