CYCLOGEST Off-white pessaries (2018)
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
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
CYCLOGEST 200mg.
Qualitative and quantitative composition
Each pessary contains 200mg Progesterone PhEur. For the full list of excipients, see section 6.1.
Pharmaceutical form
Off-white pessaries.
Therapeutic indications
Cyclogest is indicated for the: Treatment of premenstrual syndrome, including premenstrual tension and depression. Treatment of puerperal depression.
Posology and method of administration
200mg daily to 400mg twice a day, by vaginal or rectal insertion. For premenstrual syndrome commence treatment on day 14 of menstrual cycle and continue treatment until onset of menstruation. If symptoms ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Undiagnosed vaginal bleeding. Known or suspected progesterone sensitive malignant tumours. Porphyria. Severe ...
Special warnings and precautions for use
Cyclogest is not indicated in threatened miscarriage. Treatment should be discontinued in the event of a missed miscarriage. Cyclogest should be discontinued if any of the following conditions are suspected: ...
Interaction with other medicinal products and other forms of interaction
Drugs known to induce the hepatic cytochrome-P450-3A4 system (e.g. rifampicin, carbamazepine or phenytoin) may increase the elimination rate and thereby decrease the bioavailability of progesterone. The ...
Pregnancy and lactation
Pregnancy Cyclogest should not be used during pregnancy. There is limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data) Nervous ...
Overdose
There is a wide margin of safety with Cyclogest pessaries, but overdosage may produce euphoria or dysmenorrhoea.
Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital system; Progestogens; Pregnen-(4) derivatives ATC code: G03DA04 Progesterone is a naturally occurring steroid that is secreted by the ...
Pharmacokinetic properties
Not applicable.
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the SmPC.
List of excipients
Also contains: vegetable fat.
Incompatibilities
None known.
Shelf life
Three years from the date of manufacture. <u>Shelf-life after dilution/reconstitution:</u> Not applicable. <u>Shelf-life after first opening:</u> Not applicable.
Special precautions for storage
Store below 25°C in a dry place.
Nature and contents of container
The product may be supplied in strip packs contained in cartons: Carton: White backed folding box board printed on white. Strip pack: Aluminium foil lacquer-laminated to 20µm polypropylene foil and coated ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
L.D. Collins & Co. Ltd., 1st Floor, Gallery Court, 28 Arcadia Avenue, London, N3 2FG, UK
Marketing authorization number(s)
PL 02343/0005
Date of first authorization / renewal of the authorization
23 August 2000
Date of revision of the text
19 September 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
