Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Ενδείξεις και αγωγές Βρείτε θεραπευτικές ενδείξεις και αγωγές για νόσους, συμπτώματα και ιατρικές πράξεις
Γνωρίζατε ότι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

CERAZETTE Film-coated tablet (2019)

Αναφορές

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

Περιεχόμενα

Name of the medicinal product

Cerazette 75 microgram film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 75 microgram desogestrel. Excipient(s) with known effect: Each tablet contains approximately 55 mg of lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. The tablet is white, round, biconvex and 5 mm in diameter. On one side it is coded KV above 2 and on the reverse side ORGANON*.

Therapeutic indications

Contraception.

Posology and method of administration

Posology To achieve contraceptive effectiveness, Cerazette must be used as directed (see How to take Cerazette and How to start Cerazette). Special populations Renal impairment No clinical studies have ...

Contraindications

Active venous thromboembolic disorder. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Known or suspected sex-steroid sensitive malignancies. ...

Special warnings and precautions for use

If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before ...

Interaction with other medicinal products and other forms of interaction

Interactions Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. Effect of other medicinal products on Cerazette Interactions can occur ...

Fertility, pregnancy and lactation

Pregnancy Cerazette is not indicated during pregnancy. If pregnancy occurs during treatment with Cerazette, further intake should be stopped. Animal studies have shown that very high doses of progestogenic ...

Effects on ability to drive and use machines

Cerazette has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Cerazette. Since Cerazette ...

Overdose

There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and ...

Pharmacodynamic properties

Pharmacotherapeutic group: hormonal contraceptives for systemic use ATC code: G03AC09 Mechanism of action Cerazette is a progestogen-only pill, which contains the progestogen desogestrel. Like other progestogen-only ...

Pharmacokinetic properties

Absorption After oral dosing of Cerazette desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake ...

Preclinical safety data

Toxicological studies did not reveal any effects other than those, which can be explained from the hormonal properties of desogestrel. h3 .Environmental Risk Assessment (ERA) The active substance etonogestrel ...

List of excipients

Tablet core: Silica, colloidal anhydrous All-rac-α-tocopherol Lactose monohydrate Maize starch Povidone Stearic acid Film coating: Hypromellose Macrogol 400 Talc Titanium dioxide (E171)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years. Shelf-life after first opening of the sachet: 1 month.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store the blister pack in the original sachet in order to protect from light and moisture. For storage conditions after ...

Nature and contents of container

PVC/Aluminium blister: Each blister contains 28 tablets. Each carton contains 1, 3, 6 or 13 blisters packed separately in an aluminium laminated sachet. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

The active substance etonogestrel shows an environmental risk to fish. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom

Marketing authorization number(s)

PL 00025/0562

Date of first authorization / renewal of the authorization

Date of first authorisation: 09 November 1998 Date of latest renewal: 12 December 2007

Date of revision of the text

12 February 2019

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.