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EVRA Plaster (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch.

2. Qualitative and quantitative composition

Each 20 cm² transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE). Each transdermal patch releases an average of 203 micrograms of NGMN and 33.9 micrograms of ...

3. Pharmaceutical form

Transdermal patch. Thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and heat-stamped EVRA.

4.1. Therapeutic indications

Female contraception. EVRA is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years. The decision to prescribe EVRA should take into consideration ...

4.2. Posology and method of administration

Posology To achieve maximum contraceptive effectiveness, patients must be advised to use EVRA exactly as directed. For initiation instructions see How to start EVRA below. Only one transdermal patch is ...

4.3. Contraindications

Combined hormonal contraceptives (CHCs) should not be used in the following conditions. If one of these disorders occurs during the use of EVRA, EVRA must be discontinued immediately. Presence or risk ...

4.4. Special warnings and precautions for use

Warnings If any of the conditions/risk factors mentioned below is present, the suitability of EVRA should be discussed with the woman. In the event of aggravation, or first appearance of any of the conditions ...

4.5. Interaction with other medicinal products and other forms of interaction

Note: The prescribing information of concomitant medicinal products should be consulted to identify potential interactions. Pharmacodynamic interactions Concomitant use with the medicinal products containing ...

4.6. Fertility, pregnancy and lactation

Pregnancy EVRA is not indicated during pregnancy. Epidemiological studies indicate no increased risk of birth defects in children born to women who used combined oral contraceptives prior to pregnancy. ...

4.7. Effects on ability to drive and use machines

EVRA has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions in clinical trials were headache, nausea, and breast tenderness, occurring in approximately 21.0%, 16.6%, and 15.9% of patients, ...

4.9. Overdose

Serious ill effects have not been reported following accidental ingestion of large doses of oral contraceptives. Overdose may cause nausea or vomiting. Vaginal bleeding may occur in some females. In cases ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and estrogens, fixed combination ATC-code: G03AA13 Mechanism of action EVRA acts through the mechanism of gonadotropin ...

5.2. Pharmacokinetic properties

Absorption Following application of EVRA, norelgestromin and ethinyl estradiol levels in serum reach a plateau by approximately 48 hours. Steady state concentrations of norelgestromin and EE during one ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. With respect to the reproductive ...

6.1. List of excipients

<u>Backing layer:</u> Low-density pigmented polyethylene outer layer Polyester inner layer. <u>Middle layer:</u> Polyisobutylene/polybutene adhesive Crospovidone Non-woven polyester fabric Lauryl lactate. ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store in the original package in order to protect from light and moisture. Do not refrigerate or freeze.

6.5. Nature and contents of container

Primary packaging material A sachet is composed of four layers: a low-density polyethylene film (innermost layer), an aluminium foil, a low-density polyethylene film, and an outer layer of bleached paper. ...

6.6. Special precautions for disposal and other handling

The patch should be applied immediately upon removal from the protective sachet. To prevent interference with the adhesive properties of EVRA, no creams, lotions or powders should be applied to the skin ...

7. Marketing authorization holder

JANSSEN-CILAG INTERNATIONAL NV, Turnhoutseweg, 30, B-2340 Beerse, Belgium

8. Marketing authorization number(s)

EU/1/02/223/001 EU/1/02/223/002 EU/1/02/223/003

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 22 August 2002 Date of latest renewal: 22 August 2012

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