الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

sandoz inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. none pregnancy category c. there are no well-controlled trials in pregnant women treated with adapalene and benzoyl peroxide gel 0.1% / 2.5%. animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. furthermore, such studies are not always predictive of human response; therefore, adapalene and benzoyl peroxide gel 0.1% / 2.5% should be used during pregnancy only if the potential benefit justifies the risk to the fetus. no teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2 /day) the maximum recommended human dose (mrhd) of 2 grams of adapalene and benzoyl peroxide gel 0.1% / 2.5%. however, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times mrhd, respectively. findings in

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole vaginal gel usp, 0.75% is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis). - note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% koh solution, and (c) contains clue cells on microscopic examination. gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology ( 12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data) . the background ris

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

proficient rx lp - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate cream usp, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. none. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. mometasone furoate also caused dystocia and related complications when administered to

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - naftifine hydrochloride (unii: 25ur9n9041) (naftifine - unii:4fb1ton47a) - naftifine hydrochloride gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms trichophyton rubrum, trichophyton mentagrophytes, trichophyton tonsurans1 , epidermophyton floccosum1 . 1 efficacy for this organism in this organ system was studied in fewer than 10 infections. naftifine hydrochloride gel, 1% is contraindicated in individuals who have shown hypersensitivity to any of their components.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

thirty madison inc - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by pityrosporum orbiculare (also known as malassezia furfur or m. orbiculare ). note: tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. treatment of the infection may not immediately result in normalization of pigment to the affected sites. normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora. ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole vaginal gel usp, 0.75% is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis). - note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% koh solution, and (c) contains clue cells on microscopic examination. gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a)

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

bryant ranch prepack - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole vaginal gel usp, 0.75% is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis). - note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% koh solution, and (c) contains clue cells on microscopic examination. gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

bryant ranch prepack - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5%. [see adverse reactions (6.2).] clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see warnings and precautions (5.1)]. pregnancy category c. there are no adequate and well-controlled studies in pregnant women treated with clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5%. clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg per kg per day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg per m2 , respectively) or subcutaneous doses of clindamycin up to 250 mg per kg per day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg per m2 , respectively) revealed no evidence of teratogenicity. it is not known whether clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% is excreted into human milk after topical application. 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. because many drugs are excreted in human milk, caution should be exercised when clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% is administered to a nursing woman. safety and effectiveness of clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% in pediatric patients below the age of 12 have not been established. clinical studies of clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% did not include sufficient numbers of subjects ages 65 and over to determine whether they respond differently from younger subjects.

الأردن - الإنجليزية - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع أدوية ابن رشد - ibn rushd drug store - leuprorelin acetate 22.5 mg - 22.5 mg