Država: Singapur
Jezik: angleščina
Source: HSA (Health Sciences Authority)
Tacrolimus monohydrate eqv Tacrolimus
DKSH SINGAPORE PTE. LTD.
D11AH01
0.10g/100g
OINTMENT
Tacrolimus monohydrate eqv Tacrolimus 0.10g/100g
TOPICAL
Prescription Only
LEO Laboratories Limited
ACTIVE
2004-03-08
NAME OF THE MEDICINAL PRODUCT Protopic Ointment 0.03% QUALITATIVE AND QUANTITATIVE COMPOSITION 1g of Protopic 0.03% ointment contains 0.3mg of tacrolimus as tacrolimus monohydrate (0.03%). For excipients, see List of excipients PHARMACEUTICAL FORM Ointment for external application on skin. A white to slightly yellowish ointment. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years. _Adults and adolescents (16 years of age and above)_ Treatment of moderate to severe atopic dermatitis in adults and adolescents who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. _Children (2 years of age and above)_ Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. POSOLOGY AND METHOD OF ADMINISTRATION Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment. _Method of administration _ Protopic ointment should be applied as a thin layer to affected or commonly affected areas of the skin. Protopic ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. Protopic ointment should not be applied under occlusion because this method of administration has not been studied in patients (see Special warnings and special precautions for use). _Posology_ Protopic can be used for short-term and i Preberite celoten dokument
PROTOPIC ® NAME OF THE MEDICINAL PRODUCT Protopic® Ointment 0.03% Protopic® Ointment 0.1% QUALITATIVE AND QUANTITATIVE COMPOSITION 1g of Protopic® 0.03% ointment contains 0.3mg of tacrolimus as tacrolimus monohydrate (0.03%). 1g of Protopic® 0.1% ointment contains 1.0mg of tacrolimus as tacrolimus monohydrate (0.1%). For the full list of excipients, see List of Excipients. PHARMACEUTICAL FORM Ointment for external application on skin. A white to slightly yellowish ointment CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Protopic® 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years. Protopic® 0.1 % ointment is indicated in adults and adolescents (16 years of age and above) Flare treatment _Adults and adolescents (16 years of age and above)_ Treatment of moderate to severe atopic dermatitis in adults and adolescents who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. _ _ _Children (2 years of age and above)_ Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). POSOLOGY AND METHOD OF ADMINISTRATION Protopic® treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Protopic® is available in two strengths, Protopic® 0.03 % and Protopic® 0.1 % ointment. _Method of administration_ Protopic® ointment should be applied as a thin layer to affected or commonly affected areas of the skin. Protopic® ointment may be used on any part of t Preberite celoten dokument