ORGAMETRIL Tablet (2007)

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

1. Name of the medicinal product

ORGAMETRIL.

2. Qualitative and quantitative composition

Each tablet contains: 5 mg lynestrenol (ph.Eur.Spec.).

3. Pharmaceutical form

Tablets.

4.1. Therapeutic indications

Polymenorrhea Menorrhagia and metrorrhagia Selected cases of primary and secondary amenorrhea and oligomenorrhea Endometriosis Selected cases of endometrial carcinoma Benign breast disease Suppression ...

4.2. Posology and method of administration

Polymenorrhea 1 tablet daily on days 14-25 of the cycle. Menorrhagia and metrorrhagia 2 tablets daily for 10 days. Usually the bleeding will cease within a few days after the start of the treatment. Treatment ...

4.3. Contraindications

Pregnancy or suspected pregnancy. Severe liver disease such as cholestatic jaundice or hepatitis (or a history of severe liver disease if the results of liver function tests have failed to return to normal), ...

4.4. Special warnings and precautions for use

Chloasma is occasionally seen during the use of estrogen and/or progestagencontaining preparations, especially in women with a history of chloasma gravidarum. In women with a tendency to develop chloasma, ...

4.5. Interaction with other medicinal products and other forms of interaction

There are some interactions, mainly obtained with other progestagen containing preparations, activated charcoal, barbiturates (primidone included). Hydantoins and Rafampicin may possibly decrease the effectiveness ...

4.6. Pregnancy and lactation

This medicine is contraindicated during pregnancy. There are insufficient data on the use of this medicine during breast-feeding to assess potential harm.

4.8. Undesirable effects

During continuous treatment regimens with Orgametril, breakthrough bleeding or spotting will occur frequently (over 10%) during the first two months. Later on the frequency gradually decreases. During ...

4.9. Overdose

The toxicity of lynestrenol is very low. In case of overdose, e.g. young children taking several tablets simultaneously, no toxic symptoms are expected to occur. Symptoms that may occur are nausea and ...

5.1. Pharmacodynamic properties

Orgametril is an oral preparation of the synthetic progestagen, which shares various activities with the natural hormone progesterone. Lynestrenol has a strong progestational influence on the endometrium. ...

5.2. Pharmacokinetic properties

After oral administration lynestrenol is readily absorbed and subsequently converted in the liver into the pharmacologically active norethisterone. Within 2-4 hours after ingestion of lynestrenol peak ...

6.4. Special precautions for storage

Store at 2-30°C. Protect from sunlight and moisture. Keep out of the reach of children.

6.5. Nature and contents of container

Pack of 1x30s physician.

7. Marketing authorization holder

Manufactured by: N.V. Organon, Oss, The Netherlands. For: OBS Paksitan (Pvt.) Limited., C-14, S.I.T.E., Karachi – 75700 Pakistan

8. Marketing authorization number(s)

PK-ORG-2007-05

Πηγαίο έγγραφο

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

application/pdf