New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - infliximab 100mg;   - powder for injection - 100 mg - active: infliximab 100mg   excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate monohydrate polysorbate 80 sucrose - rheumatoid arthritis remicade is a ?disease-controlling anti-rheumatic therapy" (dcart) indicated for: · the reduction of signs and symptoms · prevention of structural joint damage (erosions and joint space narrowing) · improvement in physical function in patients with active disease. remicade should be given in combination with methotrexate.

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

actavis pharma, inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin 12 mg in 1 g - clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled trials in pregnant women treated with clindamycin phosphate and tretinoin gel. clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clindamycin phosphate and tretinoin gel was tested for maternal and developmental toxicity in new zealand white rabbits with topical doses of 60, 180 and 600 mg/kg/day. clindamycin phosphate and tretinoin gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (noael) for maternal and developmental toxicity following dermal administration of clindamycin phosphate and tretinoin gel for two weeks prior to artificial insemination and continuing until gestation day 18, inclusive. for purposes of comparisons of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of clindamycin phosphate and tretinoin gel applied daily to a 60 kg person. clindamycin teratology (segment ii) studies using clindamycin were performed orally in rats (up to 600 mg/kg/day) and mice (up to 100 mg/kg/day) (583 and 49 times amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) or with subcutaneous doses of clindamycin up to 180 mg/kg/day (175 and 88 times the amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) revealed no evidence of teratogenicity. tretinoin in oral segment iii studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (~ 78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison). with widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin. although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). the significance of these spontaneous reports in terms of risk to the fetus is not known. dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the recommended human clinical dose based on a body surface area comparison. oral tretinoin has been shown to be fetotoxic in rats when administered in doses 78 times the recommended clinical dose based on a body surface area comparison. it is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate and tretinoin gel. however, orally and parenterally administered clindamycin has been reported to appear in breast milk. because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. it is not known whether tretinoin is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when clindamycin phosphate and tretinoin gel is administered to a nursing woman. safety and effectiveness of clindamycin phosphate and tretinoin gel in pediatric patients under the age of 12 have not been established. clinical trials of clindamycin phosphate and tretinoin gel included patients 12 to 17 years of age. [see clinical studies (14)] clinical studies of clindamycin phosphate and tretinoin gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

lupin pharmaceuticals, inc. - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline 45 mg - minocycline hydrochloride extended-release tablets usp are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. minocycline hydrochloride extended-release tablets usp did not demonstrate any effect on non-inflammatory acne lesions. safety of minocycline hydrochloride extended-release tablets usp have not been established beyond 12 weeks of use. this formulation of minocycline has not been evaluated in the treatment of infections [see clinical studies (14)] to reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release tablets usp should be used only as indicated [see warnings and precautions (5.11)] this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. teratogenic effects: pregnancy category d [see warnings and precautions (5.1) ] minocycline hydrochloride extended-release tablets s

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

dr. reddys laboratories inc - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline 105 mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - daptomycin - powder for solution for infusion - 350mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - daptomycin - powder for solution for infusion - 500mg

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

zydus pharmaceuticals (usa) inc. - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline 45 mg - minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. safety of minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. this formulation of minocycline has not been evaluated in the treatment of infections [see clinical studies (14)]. to reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release tablets should be used only as indicated [see warnings and precautions (5.11)]. this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. minocycline hydrochloride extended-release tablets should not be used during pregnancy. if the patient becomes pregnant while taking this drug, the

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

mylan pharmaceuticals inc. - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. safety of minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. this formulation of minocycline has not been evaluated in the treatment of infections [see clinical studies (14) ]. to reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release tablets should be used only as indicated [see warnings and precautions (5.11) ]. this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. [see warnings and precautions (5.1) ]. minocycline hydrochloride extended-release tablets should not be used during pregnancy. if the patient beco

Malta - English - Medicines Authority

vocate pharmaceuticals s.a 150, gounari str, 166 74 glyfada, athens, greece - daptomycin - powder for solution for injection/infusion - daptomycin 350 mg - antibacterials for systemic use

Malta - English - Medicines Authority

vocate pharmaceuticals s.a 150, gounari str, 166 74 glyfada, athens, greece - daptomycin - powder for solution for injection/infusion - daptomycin 500 mg - antibacterials for systemic use