Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

dr reddy's new zealand limited - terbinafine hydrochloride 281.25mg equivalent to 250 mg terbinafine base);   - tablet - 250 mg - active: terbinafine hydrochloride 281.25mg equivalent to 250 mg terbinafine base)   excipient: colloidal silicon dioxide croscarmellose sodium hypromellose magnesium stearate microcrystalline cellulose - - onychomycosis (fungal infection of the nail) caused by dermatophyte fungi. - tinea capitis. - fungal infections of the skin for the treatment of tinea corporis, tinea cruris, tinea pedis, and yeast infections of the skin caused by the genus candida (e.g. candida albicans) where oral therapy is generally considered appropriate owing to the site, severity or extent of the infection.

Malta - İngilizce - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - terbinafine - tablet - terbinafine 125 mg - antifungals for dermatological use

Malta - İngilizce - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - terbinafine - tablet - terbinafine 250 mg - antifungals for dermatological use

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

rowa pharmaceuticals limited - terbinafine hydrochloride - tablet - 250 milligram(s) - antifungals for systemic use; terbinafine

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

laboratorios velvian s.l - terbinafine - tablet - 250 milligram(s) - antifungals for systemic use; terbinafine

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - terbinafine hydrochloride, quantity: 281.28 mg - tablet, uncoated - excipient ingredients: hypromellose; colloidal anhydrous silica; sodium starch glycollate type a; microcrystalline cellulose; magnesium stearate - ? treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as trichophyton (e.g. t. rubrum, t. mentagrophytes, t. verrucosum, t. violaceum), microsporum canis and epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to topical therapy. ? onychomycosis in adults (fungal infection of the nail) caused by dermatophyte fungi.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - terbinafine hydrochloride, quantity: 281.25 mg (equivalent: terbinafine, qty 250 mg) - tablet, uncoated - excipient ingredients: magnesium stearate; potato starch; sodium starch glycollate; hypromellose; colloidal anhydrous silica - treatment of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as trichophyton (e.g. t. rubrum, t.mentagrophytes, t.verrucosum, t.violaceum), microsporum canis and epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to other available treatments. onychomycosis (fungal infection of the nail) caused by dermatophyte fungi.

ABD - İngilizce - NLM (National Library of Medicine)

wockhardt usa llc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 250 mg - terbinafine hydrochloride tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine hydrochloride tablets are contraindicated in patients with: - history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2) ] - chronic or active liver disease [see warnings and precautions (5.1) ] pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine hydrochloride tablets not be initiated during pregnancy. oral reproduction studies

ABD - İngilizce - NLM (National Library of Medicine)

harris pharmaceutical, inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine hydrochloride 250 mg - terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: - chronic or active liver disease [see warnings and precautions (5.1)] - history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2)] . risk summary available data from postmarketing cases on the use of terbinafine tablets in pregnant women. are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at oral doses

ABD - İngilizce - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine hydrochloride 250 mg - terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: - chronic or active liver disease [see warnings and precautions (5.1)] - history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2)] . risk summary available data from postmarketing cases on the use of terbinafine tablets in pregnant women. are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when admi