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

TOPOGYNE Tablet (2014)

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

Topogyne 400 microgram tablets

Qualitative and quantitative composition

One tablet contains 400 microgram misoprostol. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. White, round, flat tablets, with a diameter of 11 mm and thickness of 4.4 mm, with M400 engraved on one side.

Therapeutic indications

Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea (see section 4.2). Misoprostol is indicated in adults.

Posology and method of administration

Posology Misoprostol is taken as a single 400 microgram oral dose 36 to 48 hours after taking a single 600 mg oral dose of mifepristone. Information on the posology of mifepristone can be found in the ...

Contraindications

Hypersensitivity to misoprostol or other prostaglandins, or to any of the excipients listed in section 6.1 Pregnancy not confirmed by ultrasound scan or biological tests Suspected ectopic pregnancy Contraindication ...

Special warnings and precautions for use

In the absence of specific studies, the combination of the sequential use of mifepristone and misoprostol is not recommended for use in patients with: Malnutrition Hepatic failure Renal failure Warnings ...

Interaction with other medicinal products and other forms of interaction

Misoprostol is predominantly metabolised via fatty acid oxidising systems and has shown no adverse effect on the hepatic microsomal mixed function oxidase (P450) enzyme system. A decrease of the efficacy ...

Fertility, pregnancy and lactation

Pregnancy Use in pregnancy has been associated with birth defects/malformations for ongoing pregnancies exposed to mifepristone and misoprostol or misoprostol alone. Prenatal exposure to misoprostol has ...

Effects on ability to drive and use machines

No data showing an effect on the ability to drive are known. Dizziness could occur as a side effect. When driving or using machines one should take this possible side effect into account.

Undesirable effects

The side effects of misoprostol are usually an extension of the pharmacological action and of the drug bioavailability. The most common adverse reactions are gastrointestinal disorders e.g. nausea, vomiting, ...

Overdose

In the event of overdosage, symptomatic treatment and appropriate medical care should be done. Gastrointestinal haemorrhage, renal failure, acute rhabdomyolysis, uterine haemorrhage and death have been ...

Pharmacodynamic properties

Pharmacotherapeutic class: Other gynaecological drugs, oxytocics prostaglandins ATC code: G02AD06 Misoprostol (a synthetic analogue of prostaglandin E1) is used in combination with mifepristone for the ...

Pharmacokinetic properties

Absorption Misoprostol is rapidly absorbed following oral administration, with peak plasma levels of the active metabolite (misoprostol acid) occurring after about 30 minutes. The plasma elimination half-life ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. At high repeated doses in rats ...

List of excipients

Microcrystalline cellulose Hypromellose Sodium starch glycolate (type A) Hydrogenated castor oil

Incompatibilities

Not applicable.

Shelf life

PVC-PCTFE/Alu blister: 1 year. OPA-Alu-PVC/Alu blister: 24 months.

Special precautions for storage

Store below 25°C. Any tablet stored outside the blister or not used immediately has to be discarded.

Nature and contents of container

1, 4, 16 or 40 tablet per carton box. Tablets are packed in perforated unit-dose PVC-PCTFE/Alu or OPA-Alu-PVC/Alu blister. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

EXELGYN, 216, Boulevard Saint-Germain, 75007 Paris, France

Marketing authorization number(s)

PL 16152/0003

Date of first authorization / renewal of the authorization

18/01/2013

Date of revision of the text

19/03/2014

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.