EVRA Plaster (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
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
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: