ZOELY Film-coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Zoely 2.5 mg/1.5 mg film-coated tablets.
2. Qualitative and quantitative composition
Each white active tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate). Each yellow placebo tablet does not contain active substances. <u>Excipients with known effect:</u> ...
3. Pharmaceutical form
Film-coated tablet (tablet). The active tablet is white, round and coded ne on both sides. The placebo tablet is yellow, round and coded p on both sides.
4.1. Therapeutic indications
Oral contraception. The decision to prescribe Zoely should take into consideration the individual womans current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE ...
4.2. Posology and method of administration
Posology One tablet is to be taken daily for 28 consecutive days. Each pack starts with 24 white active tablets, followed by 4 yellow placebo tablets. A subsequent pack is started immediately after finishing ...
4.3. Contraindications
CHCs must not be used in the following conditions. Should any of the conditions appear for the first time during Zoely use, the medicinal product should be stopped immediately. Presence or risk of venous ...
4.4. Special warnings and precautions for use
Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Zoely should be discussed with the woman. In the event of aggravation, or first appearance of any of these ...
4.5. Interaction with other medicinal products and other forms of interaction
Interactions Note: The prescribing information of concomitant medicinal products should be consulted to identify potential interactions. Influence of other medicinal products on Zoely Interactions between ...
4.6. Fertility, pregnancy and lactation
Pregnancy Zoely is not indicated during pregnancy. If pregnancy occurs while taking Zoely, further intake should be stopped. Most epidemiological studies have revealed neither an increased risk of birth ...
4.7. Effects on ability to drive and use machines
Zoely has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile Six multi-centre clinical trials of up to one-year duration were used to evaluate safety of Zoely. In total 3,434 women, aged 18-50, were enrolled and completed 33,828 cycles. ...
4.9. Overdose
Multiple doses up to five times the daily dose of Zoely and single doses up to 40 times the daily dose of nomegestrol acetate alone have been used in women without safety concern. On the basis of general ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Sex hormones and modulators of the genital system, progestogens and estrogens, fixed combinations <b>ATC code:</b> G03AA14 Mechanism of action Nomegestrol acetate is a ...
5.2. Pharmacokinetic properties
Nomegestrol acetate Absorption Orally administered nomegestrol acetate is rapidly absorbed. Maximum plasma concentrations of nomegestrol acetate of about 7 ng/mL are reached at 2 h after single administration. ...
5.3. Preclinical safety data
Repeated dose toxicity studies with estradiol, nomegestrol acetate or combination have indicated expected oestrogenic and gestagen effects. Reproductive toxicity studies performed with the combination ...
6.1. List of excipients
<u>Tablet core (white active and yellow placebo film-coated tablets):</u> Lactose monohydrate Microcrystalline cellulose (E460) Crospovidone (E1201) Talc (E553b) Magnesium stearate (E572) Colloidal anhydrous ...
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
PVC/aluminium blister containing 28 film-coated tablets (24 white active tablets and 4 yellow placebo tablets). <u>Pack sizes:</u> 28, 84, 168 and 364 film-coated tablets. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
COC tablets (including Zoely tablets) no longer required should not be disposed via wastewater or the municipal sewage system. The hormonal active compounds in the tablets may have harmful effects if reaching ...
7. Marketing authorization holder
Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
8. Marketing authorization number(s)
EU/1/11/690/001 EU/1/11/690/002 EU/1/11/690/003 EU/1/11/690/004
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 27 July 2011 Date of latest renewal: 10 May 2021
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