USA - engelsk - NLM (National Library of Medicine)

preferred pharmaceuticals, inc - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine hydrochloride 250 mg - terbinafine hydrochloride (hcl) 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 (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. terbinafine hcl 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 hcl 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 n

USA - engelsk - NLM (National Library of Medicine)

dr.reddys laboratories limited - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 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 (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 hydrochloride 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

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 250 mg - terbinafine hydrochloride 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 hydrochloride 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 reve

USA - engelsk - NLM (National Library of Medicine)

wockhardt usa, llc - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine hydrochloride 250 mg - terbinafine hydrochloride tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) (see dosage and administration and clinical studies). 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 hydrochloride tablets are contraindicated in individuals with hypersensitivity to terbinafine or to any other ingredients of the formulation.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - terbinafine hydrochloride -

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - NLM (National Library of Medicine)

wockhardt limited - 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) (see dosage and administration and clinical studies). 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 hydrochloride tablets are contraindicated in individuals with hypersensitivity to terbinafine or to any other ingredients of the formulation.

USA - engelsk - NLM (National Library of Medicine)

rebel distributors corp - 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) (see dosage and administration and clinical studies ).   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 hydrochloride tablets are contraindicated in individuals with hypersensitivity to terbinafine or to any other ingredients of the formulation.