KLIOVANCE Film-coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Kliovance 1 mg/0.5 mg film-coated tablets.
2. Qualitative and quantitative composition
<u>Each film-coated tablet contains:</u> Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg. Excipient with known effect: lactose monohydrate. For the full list of excipients, ...
3. Pharmaceutical form
Film-coated tablets. White film-coated, round, biconvex tablets with a diameter of 6 mm. The tablets are engraved with NOVO 288 on one side and the Apis bull on the other.
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
Kliovance 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. Fertility, pregnancy and lactation
Pregnancy Kliovance is not indicated during pregnancy. If pregnancy occurs during medication with Kliovance, treatment should be withdrawn immediately. Clinically, data on a limited number of exposed pregnancies ...
4.7. Effects on ability to drive and use machines
Kliovance 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 Kliovance were vaginal bleeding and breast pain/tenderness, reported in approximately 10% to 20% of patients. ...
4.9. Overdose
Overdose may be manifested by nausea and vomiting. Treatment should be symptomatic.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Progestagens and oestrogens, fixed combinations <b>ATC code:</b> G03FA01 Mechanism of action Estradiol The active ingredient, synthetic 17β-estradiol, is chemically and ...
5.2. Pharmacokinetic properties
Absorption and distribution of 17β-estradiol Following oral administration of 17β-estradiol in micronised form, rapid absorption from the gastrointestinal tract occurs. It undergoes extensive first-pass ...
5.3. Preclinical safety data
The acute toxicity of oestrogens is low. Because of marked differences between animal species and between animals and humans, preclinical results possess a limited predictive value for the application ...
6.1. List of excipients
<u>Tablet core:</u> Lactose monohydrate Maize starch Copovidone Talc Magnesium stearate <u>Film-coating:</u> Hypromellose Triacetin Talc
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. 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 or 3 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 ...
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 Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA
8. Marketing authorization number(s)
PL 03132/0125
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 06 March 1998 Date of latest renewal: 06 March 2013
10. Date of revision of the text
09/2020
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