Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand 1685, South Africa
EVOREL CONTI.
Patch.
| Pharmaceutical Form |
|---|
|
EVOREL CONTI is a matrix type transdermal patch. EVOREL CONTI is a flexible, square, colourless adhesive patch of 16 cm 2 with convex edges and rounded corners. The adhesive surface of the patch is covered with a protective foil with an S shaped incision. Each patch is marked in the centre of the lower margin on the outside of the backing film: CEN1. |
Each EVOREL CONTI patch contains 3,1 mg estradiol, formulated as 3,2 mg of estradiol hemihydrate and 9,82 mg norethisterone, formulated as 11,2 mg of norethisterone acetate. The patch delivers 50 μg of estradiol and 170 μg of norethisterone acetate per 24 hours. EVOREL CONTI contains no sugar.
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Estradiol |
Estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy. |
|
| Norethisterone |
Norethisterone has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak oestrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle. |
| List of Excipients |
|---|
|
Adhesive: acrylate vinylacetate copolymer |
Cartons containing eight EVOREL CONTI patches in foil lined pouches.
The pouch comprises a 4 layer laminate including an aluminium barrier and paper exterior surface.
Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand 1685, South Africa
31/21.8.2/0537
Namibian Reg No.: 04/21.8.2/0244
NS 2
Date of registration: 16 February 1998
| Drug | Countries | |
|---|---|---|
| EVOREL CONTI | Finland, Ireland, Israel, Mexico, United Kingdom, South Africa |
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