Country: Канада
Језик: Енглески
Извор: Health Canada
PODOPHYLLOTOXIN
STIEFEL LABORATORIES (IRELAND) LIMITED
D06BB04
PODOPHYLLOTOXIN
5MG
LIQUID
PODOPHYLLOTOXIN 5MG
TOPICAL
3ML
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0123181001; AHFS:
CANCELLED POST MARKET
2015-04-30
_2013-12-24/131-pristine-english-wartec.doc _ _ _ _ _ _Page 1 of 19_ PRODUCT MONOGRAPH PR WARTEC ® PODOFILOX TOPICAL SOLUTION 0.5% W/V ANTIMITOTIC AGENT Stiefel Laboratories (Ireland) Limited Date of Revision: Finisklin Industrial Estate December 24, 2013 Sligo, IRELAND Control # 170147 _®_ _WARTEC is a registered trademark of Stiefel Laboratories, Inc., used under license by GlaxoSmithKline Inc._ _ _ _2013-12-24/131-pristine-english-wartec.doc _ _ _ _ _ _Page 2 of 19_ PRODUCT MONOGRAPH PR WARTEC ® Podofilox topical solution 0.5% w/v THERAPEUTIC CLASSIFICATION Antimitotic Agent ACTIONS Necrosis of visible tissue is observed following treatment of genital warts with Podofilox. The exact mechanism of action is_ _unknown. Podofilox is_ _a metaphase inhibitor of dividing cells. Podofilox binds to at least one binding site on tubulin. This binding prevents the tubulin polymerisation required for microtubule assembly. At higher concentrations Podofilox also inhibits nucleoside transport through the cell membrane. The chemotherapeutic action of Podofilox is assumed to be due to inhibition of growth and the ability to invade the tissue of the virus-infected cells. Podofilox prevents cell division in the virus infected cells of the condylomata acuminata. _2013-12-24/131-pristine-english-wartec.doc _ _ _ _ _ _Page 3 of 19_ INDICATIONS WARTEC ® (Podofilox 0.5% topical solution) is indicated for the topical treatment of external genital warts (Condylomata acuminata) confined to the penile and vulvar regions. CONTRAINDICATIONS WARTEC ® (Podofilox 0.5% topical solution) is contraindicated for patients who develop or have known hypersensitivity to Podofilox or to any component in the formulation (ethanol, phosphoric acid) _(SEE _ _PHARMACEUTICAL INFORMATION DESCRIPTION SECTION)._ Open or bleeding wounds should not be treated with WARTEC ® (Podofilox). WARNINGS WARTEC ® (PODOFILOX TOPICAL SOLUTION 0.5%) IS INTENDED FOR TOPICAL USE ONLY. PODOFILOX IS A POTENT VESICANT AND IS TO BE USED ONLY AS DIRECTED BY A PHYSICIAN. EXTR Прочитајте комплетан документ