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

arrotex pharmaceuticals pty ltd - terbinafine hydrochloride, quantity: 281.3 mg (equivalent: terbinafine, qty 250 mg) - tablet, uncoated - excipient ingredients: methylcellulose; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica - apo-terbinafine is indicated for: treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infections 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.

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

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

arrotex pharmaceuticals pty ltd - terbinafine hydrochloride, quantity: 281.25 mg (equivalent: terbinafine, qty 250 mg) - tablet - excipient ingredients: hypromellose; colloidal anhydrous silica; croscarmellose sodium; 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.

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

actavis new zealand limited - terbinafine hydrochloride 281.25mg equivalent to 250 mg terbinafine - tablet - 250 mg - active: terbinafine hydrochloride 281.25mg equivalent to 250 mg terbinafine excipient: colloidal silicon dioxide hypromellose magnesium stearate microcrystalline cellulose sodium starch glycolate

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - terbinafine hydrochloride 281.25mg equivalent to terbinafine 250 mg;   - tablet - 250 mg - active: terbinafine hydrochloride 281.25mg equivalent to terbinafine 250 mg   excipient: colloidal silicon dioxide croscarmellose sodium hypromellose magnesium stearate microcrystalline cellulose purified water

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

laboratorios liconsa, s.a. - terbinafine - tablets - 250 milligram - antifungals for systemic use - antifungals for systemic use - it is indicated in the treatment of the following skin and nail fungal infections: treatment of tinea corporis, tinea cruris and tinea pedis, when oral therapy is considered appropriate depending on the site, severity or extent of the infection and for the treatment of onychomycosis caused by dermatophytes

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: colloidal anhydrous silica; hypromellose; potato starch; magnesium stearate; sodium starch glycollate - 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)

camber pharmaceuticals, inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 250 - terbinafine tablets, usp 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 (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis. 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 not be initiated during pregnancy. oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day (12x to 23x the mrhd, in rabbits and rats, respectively, based on bsa) and have revealed no evidence of impaired

ABD - İngilizce - NLM (National Library of Medicine)

proficient rx lp - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 250 - terbinafine tablets, usp 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 (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis. 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 not be initiated during pregnancy. oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day (12x to 23x the mrhd, in rabbits and rats, respectively, based on bsa) and have revealed no evidence of impaired