KLIOGEST Film-coated tablet (2022)

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

Kliogest 2 mg/1 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains: estradiol 2 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg. Excipient with known effect: lactose monohydrate. Each white film-coated tablet ...

3. Pharmaceutical form

Film-coated tablets. White, film-coated, biconvex tablets, engraved with NOVO 281. Diameter 6 mm.

4.1. Therapeutic indications

Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with more than 1 year since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future ...

4.2. Posology and method of administration

Kliogest is a continuous combined HRT product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day. ...

4.3. Contraindications

Known, past or suspected breast cancer. Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer). Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous ...

4.4. Special warnings and precautions for use

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken ...

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

The metabolism of oestrogens and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants ...

4.6. Pregnancy and lactation

Pregnancy Kliogest is not indicated during pregnancy. If pregnancy occurs during medication with Kliogest, treatment should be withdrawn immediately. Clinically, data on a limited number of exposed pregnancies ...

4.7. Effects on ability to drive and use machines

Kliogest has no known effect on the ability to drive or use machines.

4.8. Undesirable effects

Clinical experience The most frequently reported adverse events in the clinical trials with Kliogest were vaginal bleedings and breast pain/tenderness, reported in approximately 10% to 30% of patients. ...

4.9. Overdose

Symptoms of over dosage with oral oestrogens are breast tenderness, nausea, vomiting and/or metrorrhagia. Over dosage of progestagens may lead to a depressive mood, fatigue, acne and hirsutism. Treatment ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Progestagens and oestrogens, fixed combinations ATC code: G03FA01 Estradiol: The active ingredient, synthetic 17β-estradiol, is chemically and biologically ...

5.2. Pharmacokinetic properties

Following oral administration of 17β-estradiol in micronised form, rapid absorption from the gastrointestinal tract occurs. It undergoes extensive first-pass metabolism in the liver and other enteric organs, ...

5.3. Preclinical safety data

The toxicity profiles of estradiol and norethisterone acetate are well-known. There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections ...

6.1. List of excipients

Tablet core: Lactose monohydrate Maize starch Hydroxypropylcellulose Talc Magnesium stearate Film-coating: White tablets: Hypromellose Triacetin Talc

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

4 years.

6.4. Special precautions for storage

Store below 25ºC. Do not refrigerate. Keep the container in the outer carton in order to protect it from light.

6.5. Nature and contents of container

1 28 tablets in calendar dial packs. The calendar dial pack with 28 tablets consists of the following 3 parts: The base made of coloured non-transparent polypropylene. The ring-shaped lid made of transparent ...

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark

8. Marketing authorization number(s)

PA0218/022/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 18 November 1987 Date of last renewal: 18 November 2007

10. Date of revision of the text

July 2022

Πηγαίο έγγραφο

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

application/pdf