EVOREL CONTI Patch (2021)
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Περιεχόμενα
1. Name of the medicinal product
EVOREL CONTI. Patch.
2. Qualitative and quantitative composition
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 ...
3. 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 ...
4.1. Therapeutic indications
Hormone replacement therapy (HRT) for the relief of menopausal symptoms (vasomotor symptoms such as hot flushes and atrophic vaginitis/vulvitis) for women with an intact uterus.
4.2. Posology and method of administration
Posology ADULTS EVOREL CONTI should be applied twice weekly, without interruption to the trunk below the waist. EVOREL CONTI should not be continued for longer than 5 years. Should a patch fall off, it ...
4.3. Contraindications
Known hypersensitivity to estradiol, norethisterone acetate or any other component of this product listed in section 6.1. Known current or past or suspected breast cancer. Family history of breast cancer. ...
4.4. Special warnings and precautions for use
Prior to commencing, and periodically during therapy, it is recommended that the patient be given a thorough physical and gynaecological examination. A complete medical and family history of thrombophlebitis ...
4.5. Interaction with other medicinal products and other forms of interaction
Medicines which induce microsomal liver enzyme activity may alter estrogen and progestogen metabolism and reduce the therapeutic effect of EVOREL CONTI. Examples of such medicines are barbiturates, hydantoins, ...
4.6. Pregnancy and lactation
Pregnancy The use of EVOREL CONTI is contraindicated in pregnancy (see section 4.3). If pregnancy occurs during medication with EVOREL CONTI, treatment should be withdrawn immediately. Breastfeeding The ...
4.7. Effects on ability to drive and use machines
No information available.
4.8. Undesirable effects
Tabulated summary of adverse reactions Clinical Trial Data The safety of EVOREL CONTI was evaluated in 196 subjects in 3 clinical trials (including 2 activecontrolled trials and 1 single arm trial). Adverse ...
4.9. Overdose
Symptoms of overdose of EVOREL CONTI therapy may include nausea, break-through bleeding, breast tenderness, abdominal cramps and/or bloating. These symptoms can be reversed by removing the EVOREL CONTI. ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 21.8.2 Progesterones with estrogens EVOREL CONTI contains estradiol hemihydrates (17β-estradiol), which is a synthetically prepared estrogen and norethisterone ...
5.2. Pharmacokinetic properties
Estradiol Estradiol distributes widely in the body tissues and is bound to albumin (about 60-65%) and sexhormone-binding globulin (about 35-45%) in serum. Serum protein binding fractions remain unaltered ...
6.1. List of excipients
Adhesive: acrylate vinylacetate copolymer Guar gum Backing film: polyethylene terephthalate foil Release liner: siliconised polyethylene terephthalate foil which is removed before application.
6.2. Incompatibilities
No data available.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Store at or below 25°C. Do not freeze.
6.5. Nature and contents of container
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.
6.6. Special precautions for disposal and other handling
Once removed, the patches should be disposed of in household waste (do not flush down the toilet).
7. Marketing authorization holder
Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand 1685, South Africa
8. Marketing authorization number(s)
31/21.8.2/0537 Namibian Reg No.: 04/21.8.2/0244 NS 2
9. Date of first authorization / renewal of the authorization
Date of registration: 16 February 1998
10. Date of revision of the text
17 December 2021
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