LEVONELLE Tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Levonelle 1500 microgram tablet.
2. Qualitative and quantitative composition
Each tablet contains 1500 micrograms of levonorgestrel. <u>Excipient with known effect:</u> 142.5 mg lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Almost white, flat, rimmed tablet of about 8 mm diameter with an impressed mark of G00 on one side.
4.1. Therapeutic indications
Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.
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 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 Levonorgestrel 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 fetus ...
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 performed.
4.8. Undesirable effects
The most commonly reported undesirable effect was nausea. System Organ Class Frequency of adverse reactions Very common (≥1/10) Common (≥1/100 to <1/10) <b>Nervous system disorders</b> Headache Dizziness ...
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. The absolute bioavailability of levonorgestrel was determined to be almost 100% of the dose administered. The results ...
5.3. Preclinical safety data
Animal experiments with levonorgestrel have shown virilisation of female fetuses at high doses. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...
6.1. List of excipients
Potato starch Maize starch Colloidal silica anhydrous Magnesium stearate Talc Lactose monohydrate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store in original packaging in order to protect from light.
6.5. Nature and contents of container
PVC/Aluminium-blister containing one tablet. The blister is packaged in a folded carton.
6.6. Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
8. Marketing authorization number(s)
PL 04854/0150
9. Date of first authorization / renewal of the authorization
14<sup>th</sup> June 2004
10. Date of revision of the text
02/07/2021
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