PROGYNOVA 2mg Coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Progynova 2 mg Tablets.
2. Qualitative and quantitative composition
Each memo pack contains 28 tablets each containing estradiol valerate 2.0 mg. <u>Excipients with known effect:</u> Lactose monohydrate and sucrose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White sugar coated tablet for oral administration.
4.1. Therapeutic indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in peri- and postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant ...
4.2. Posology and method of administration
Posology Progynova is an oestrogen-only product. One tablet of Progynova 2 mg to be taken daily. It does not matter at what time of day the woman takes her tablet, but once she has selected a particular ...
4.3. Contraindications
Known, past or suspected breast cancer. Known or suspected oestrogen-dependent malignant tumours e.g. endometrial cancer. Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous idiopathic ...
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 risk and benefits should be undertaken ...
4.5. Interaction with other medicinal products and other forms of interaction
Note: The prescribing information of concomitant medication should be consulted to identify potential interactions. Effects of other medicinal products on Progynova <u>Substances increasing the clearance ...
4.6. Pregnancy and lactation
Pregnancy Progynova is not indicated during pregnancy. If pregnancy occurs during medication with Progynova treatment should be withdrawn immediately. The results of most epidemiological studies to date ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. No effects on ability to drive and use machines have been observed in users of Progynova.
4.8. Undesirable effects
The following undesirable effects have been reported in users of Progynova and other oral HRT preparations. <u>Neoplasms benign, malignant and unspecified:</u> Breast cancer*, Endometrial cancer* <u>Immune ...
4.9. Overdose
Overdose may cause nausea and vomiting and withdrawal bleeding may occur in some women. There are no specific antidotes and treatment should be symptomatic.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Sex hormones and modulators of the genital system, natural and semisynthetic oestrogens, plain <b>ATC code:</b> G03CA03 Estradiol/estradiol valerate Progynova contains ...
5.2. Pharmacokinetic properties
Absorption After oral administration estradiol valerate is quickly and completely absorbed. Distribution Already after 0.5-3 hours peak plasma levels of estradiol, the active drug substance, are measured. ...
5.3. Preclinical safety data
There are no preclinical safety data which could be of relevance to the prescriber and which are not already included in other relevant sections of the SPC.
6.1. List of excipients
Lactose monohydrate Maize starch Povidone 25 Talc Magnesium stearate [E572] Sucrose Povidone 90 Macrogol 6000 Calcium carbonate [E170] Glycol montanate Purified water
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
None.
6.5. Nature and contents of container
Container consists of aluminium foil and PVC blister strips packed in a cardboard carton <u>Presentation:</u> Carton containing memo-packs of either 1 28 tablets or 3 28 tablets.
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
8. Marketing authorization number(s)
PL 00010/0557
9. Date of first authorization / renewal of the authorization
1 May 2008
10. Date of revision of the text
26 August 2020
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