Source: Health Products and Food Branch (CA) Revision Year: 2017
OESCLIM – Estradiol-17β transdermal system.
| Route of Administration | Dosage Form/Strength | Clinically Relevant Nonmedicinal Ingredients |
|---|---|---|
| Transdermal | Transdermal patch 25, 37.5, 50, 75, 100mcg/24 hrs | For a complete listing see Dosage Forms, Composition and Packaging section. |
Description: Rectangular transdermal system (11, 16.5, 22, 33 or 44 cm²), with rounded corners, consisting of a transparent adhesive layer laminated onto a beige foam backing. The adhesive is protected by a transparent peelable release liner. Each system is contained in a heat-sealed paper/aluminium sachet.
Composition: Ethylene/vinyl acetate copolymer, dipropylene glycol, octyl dodecanol, ethylcellulose.
OESCLIM 25: Each rectangular (11 cm²) transdermal system contains estradiol hemihydrate corresponding to 5 mg estradiol for delivery of estradiol 25 mcg/24 hrs. Patient pack of 8 systems.
OESCLIM 37.5: Each rectangular (16.5 cm²) transdermal system contains estradiol hemihydrate corresponding to 7.5 mg estradiol for delivery of estradiol 37.5 mcg/24 hrs. Patient pack of 8 systems.
OESCLIM 50: Each rectangular (22 cm²) transdermal system contains estradiol hemihydrate corresponding to 10 mg estradiol for delivery of estradiol 50 mcg/24 hrs. Patient pack of 8 systems.
OESCLIM 75: Each rectangular (33 cm²) transdermal system contains estradiol hemihydrate corresponding to 15 mg estradiol for delivery of estradiol 75 mcg/24 hrs. Patient pack of 8 systems.
OESCLIM 100: Each rectangular (44 cm²) transdermal system contains estradiol hemihydrate corresponding to 20 mg estradiol for delivery of estradiol 100 mcg/24 hrs. Patient pack of 8 systems.
Oesclim transdermal system has the following composition:
OESCLIM patches are made up of a self-adhesive polymer matrix, which contains the estradiol, backed onto a rectangular foam mounting with rounded corners. The adhesive surface is covered by a transparent silicone-treated protective film which must be removed before use. This system provides excellent local tolerability and adhesion.
The active component of the system is estradiol-17β. The drug matrix provides a source for continuous delivery of drug for at least 4 days. The composition of each of the systems per unit area is identical.
The mean dose of estradiol-17β absorbed per 24 hours is about 25 mcg for OESCLIM 25, 50 mcg for OESCLIM 50 and 100 mcg for OESCLIM 100. Physiological serum concentrations of estradiol, proportional to the quantity administered, are reached four hours after application of the patch.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Searchlight Pharma Inc., 1600 Notre Dame St. West, Suite 312, Montréal, Québec, H3J 1M1 199389 |
Date of approval:
April 28, 2015 February 23, 2017 |
| Drug | Countries | |
|---|---|---|
| OESCLIM | Canada, France, Poland |
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