Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
BETAMETHASONE (BETAMETHASONE DIPROPIONATE)
ORGANON CANADA INC.
D07AC01
BETAMETHASONE
0.05%
OINTMENT
BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.05%
TOPICAL
15G/50G
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0106299002; AHFS:
APPROVED
2011-03-02
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION DIPROLENE ® betamethasone dipropionate ointment, Organon Standard 0.05% W/W Topical Corticosteroid ORGANON CANADA INC. Date of Initial Approval 16766 route Transcanadienne January 07, 1985 Kirkland, Quebec H9H 4M7 Date of Revision: April 13, 2021 www.organon.ca Control # : 249779 2 PRODUCT MONOGRAPH NAME OF DRUG DIPROLENE ® betamethasone dipropionate ointment 0.05% W/W PHARMACOLOGICAL CLASSIFICATION Topical corticosteroid ACTIONS DIPROLENE ® provides anti-inflammatory, antipruritic and vasoconstrictive effects. The propylene glycol components of the vehicle increase penetration and enhance the local effectiveness of betamethasone dipropionate. INDICATIONS AND CLINICAL USES DIPROLENE ® is indicated for the relief of the inflammatory manifestations of resistant or severe psoriasis and corticosteroid-responsive dermatoses. CONTRAINDICATIONS DIPROLENE ® is contraindicated in viral diseases including vaccinia, varicella, herpes simplex, and fungal infections; also, tuberculosis of the skin. DIPROLENE ® products are contraindicated in those patients with a history of sensitivity reactions to betamethasone dipropionate, other corticosteroids or to any of the components of DIPROLENE ® products. WARNINGS Do not use in or near the eyes since DIPROLENE ® is not formulated for ophthalmic use. This product should not be used under occlusive dressing. 3 Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children. Pregnancy and lactation: Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients. Since it is not known whether topical administration of cortic Διαβάστε το πλήρες έγγραφο