EZINELLE Tablet (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
Ezinelle 1.5 mg tablet.
2. Qualitative and quantitative composition
Each tablet contains 1.5 mg of levonorgestrel. <u>Excipient with known effect:</u> Each tablet contains 154 mg lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. The tablet is a round, white to off-white, uncoated flat tablet debossed 145 on one side and plain on the other side.
4.1. Therapeutic indications
Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. Ezinelle is indicated in adults and adolescents >16 years of age.
4.2. Posology and method of administration
Posology One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse (see section 5.1). If vomiting occurs within three hours of ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method. Emergency contraception does not prevent a pregnancy in every instance. If there is uncertainty ...
4.5. Interaction with other medicinal products and other forms of interaction
The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers, mainly CYP3A4 enzyme inducers. Concomitant administration of efavirenz has been found to reduce plasma levels of ...
4.6. Fertility, pregnancy and lactation
Pregnancy Ezinelle should not be given to pregnant women. It will not interrupt a pregnancy. In the case of continued pregnancy, limited epidemiological data indicate no adverse effects on the foetus but ...
4.7. Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been reported.
4.8. Undesirable effects
The most commonly reported undesirable effect was nausea. The following undesirable effects were observed in two different studies. Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), ...
4.9. Overdose
Serious undesirable effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea, and withdrawal bleeding may occur. There are no specific antidotes ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Sex hormones and modulators of the genital system, emergency contraceptives <b>ATC code:</b> G03AD01 Mechanism of action At the recommended regimen, levonorgestrel is ...
5.2. Pharmacokinetic properties
Absorption Orally administered levonorgestrel is rapidly and almost completely absorbed. Distribution The results of a pharmacokinetic study carried out with 16 healthy women showed that following ingestion ...
5.3. Preclinical safety data
Animal experiments with levonorgestrel have shown virilisation of female foetuses at high doses. Preclinical data from conventional studies on chronic toxicity, mutagenicity and carcinogenicity reveal ...
6.1. List of excipients
Povidone K-25 Lactose monohydrate Maize starch Silica, colloidal anhydrous Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Blister composed of PVC film coated with PVDC and aluminium foil. <u>Pack size:</u> 1 tablet.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Generics (UK) Ltd t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
8. Marketing authorization number(s)
PL 04569/1486
9. Date of first authorization / renewal of the authorization
13/05/2015
10. Date of revision of the text
04/2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
