ZAFRILLA Tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Zafrilla 2mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 2 mg dienogest. <u>Excipient with known effect:</u> each tablet contains 62.80 mg lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White or almost white, round, flat, bevelled-edge tablets, engraved with G 93 on one side and with RG on the other side. The diameter of the tablets is 7 mm.
4.1. Therapeutic indications
Treatment of endometriosis.
4.2. Posology and method of administration
Posology The dosage of Zafrilla is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. The tablet can be taken with or without food. Tablets must ...
4.3. Contraindications
Zafrilla should not be used in the presence of any of the conditions listed below, which are partially derived from information on other progestogen-only preparations. Should any of the conditions appear ...
4.4. Special warnings and precautions for use
Warnings As Zafrilla is a progestogen-only preparation it can be assumed that the special warnings and precautions for use of progestogen-only preparations are also valid for the use of Zafrilla although ...
4.5. Interaction with other medicinal products and other forms of interaction
Note: The prescribing information of concomitant medication should be consulted to identify potential interactions. Effects of other medicinal products on {(Invented) name} Progestogens including dienogest ...
4.6. Fertility, pregnancy and lactation
Pregnancy There is limited data from the use of dienogest in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ...
4.7. Effects on ability to drive and use machines
No effects on the ability to drive and use machines have been observed in users of products containing dienogest.
4.8. Undesirable effects
Presentation of undesireable effects is based on MedDRA. The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions. Undesirable effects are more common ...
4.9. Overdose
Acute toxicity studies performed with dienogest did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose. There is no specific antidote. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Sex hormones and modulators of the genital system, progestogens <b>ATC code:</b> G03DB08 Dienogest is a nortestosterone derivative with no androgenic but rather an antiandrogenic ...
5.2. Pharmacokinetic properties
Absorption Orally administered dienogest is rapidly and almost completely absorbed. Peak serum concentrations of 47 ng/mL are reached at about 1.5 hours after single ingestion. Bioavailability is about ...
5.3. Preclinical safety data
Preclinical data reveal no special risks for humans based on conventional studies of repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction. However, it should be borne ...
6.1. List of excipients
Lactose monohydrate Maize starch, pregelatinised Cellulose, microcrystalline Povidone K-25 Crospovidone (type A) Talc Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store in the original package in order to protect from light. This medicinal product does not require any special temperature storage conditions.
6.5. Nature and contents of container
28, 84, 168 Zafrilla 2 mg tablets are packaged in green, hard PVC//Al calendar blisters in folded carton box. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary
8. Marketing authorization number(s)
PA1330/023/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 12<sup>th</sup> April 2019
10. Date of revision of the text
April 2021
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