VISANNE Tablet

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Visanne 2 mg tablets.

Qualitative and quantitative composition

Each tablet contains 2 mg dienogest. Excipient with known effect: each tablet contains 62.8 mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablets. White to off-white, round, flat-faced, bevelled-edge tablets with a debossed B on one side and a diameter of 7 mm.

Therapeutic indications

Treatment of endometriosis.

Posology and method of administration

Method of administration For oral use. Posology The dosage of Visanne 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 ...

Contraindications

Visanne should not be used in the presence of any of the conditions listed below, which are partially derived from information on other progesteron-only preparations. Should any of the conditions appear ...

Special warnings and precautions for use

Warnings As Visanne 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 Visanne although ...

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 Visanne Progestogens including dienogest are metabolized ...

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). ...

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.

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 ...

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. ...

Pharmacodynamic properties

Pharmacotherapeutic group: progestogens; ATC code: G03DB08 Dienogest is a nortestosterone derivative with no androgenic but rather an antiandrogenic activity of approximately one third of that of cyproterone ...

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 ...

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 ...

List of excipients

Crospovidone Lactose monohydrate Magnesium stearate Microcrystalline cellulose Potato starch Povidone K25 Talc

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Store in the original packaging to protect from light.

Nature and contents of container

The tablets are contained in blister packs consisting of green transparent films made of polyvinylidene chloride (PVDC) coated polyvinyl chloride (PVC) and metallic foils made of aluminum (mat side hot ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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