PROGYLUTON Coated tablets (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Progyluton.
2. Qualitative and quantitative composition
Active substances: Calendar-pack containing 11 white tablets of 2 mg estradiol valerate each, plus 10 light brown tablets of 2 mg estradiol valerate and 0.5 mg norgestrel each. <u>Excipients:</u> Each ...
3. Pharmaceutical form
Coated tablets.
4.1. Therapeutic indications
Two phase preparation for climacteric and cycle disturbances.
4.2. Posology and method of administration
Progyluton is a cyclic HRT product. One tablet is to be taken orally once a day for 21 days, followed by a 7-day tablet free interval. Therefore each new pack is started after a 28 day cycle. The white ...
4.3. Contraindications
hypersensitivity to the active substance or to any of the excipients, present or suspected breast cancer, a present or suspected sex-hormone dependent premalignant or malignant disease, untreated endometrial ...
4.4. Special warnings and precautions for use
Every hormone replacement therapy (HRT) must be preceded by a clinical check on general health and a thorough gynecological examination, and the latter should be repeated at least once a year. The patient ...
4.5. Interaction with other medicinal products and other forms of interaction
In order to detect potential interactions, the summary of product characteristics of the concomitantly administered medicinal products should also be consulted. Pharmacokinetic interactions Influence of ...
4.6. Fertility, Pregnancy and lactation
The use of Progyluton is contraindicated during pregnancy. If pregnancy occurs or is suspected during its use, the drug must be discontinued immediately. There are, on the strength of animal experiments, ...
4.7. Effects on ability to drive and use machines
No studies have carried out in this respect. Progyluton is not expected to influence the ability to drive or operate machines, cf. however the section Undesirable effects.
4.8. Undesirable effects
The serious undesirable effects linked to the use of an HRT are also described in the section Special warnings and special precautions for use (q.v.). The following lists the undesirable effects by organ ...
4.9. Overdose
Owing to the low acute toxicity of the active substances estradiol valerate and norgestrel no acute intoxication risk is likely, even if a multiple of the therapeutically required dose is ingested by mistake ...
5.1. Pharmacodynamic properties
<b>ATC code:</b> G03FB01 Mode of action Progyluton is a two-step HRT preparation for after the menopause and for regulating the cycle in younger women. Estradiol After oral administration the active substance ...
5.2. Pharmacokinetic properties
Estradiol valerate Absorption After oral administration, estradiol valerate is rapidly and completely absorbed. The steroid ester is split into estradiol and valeric acid as soon as it reaches the intestinal ...
5.3. Preclinical safety data
Carcinogenicity Preclinical trials with estradiol and combinations of estradiol with progestogens on repeateddose toxicity, genotoxicity and carcinogenic potential failed to provide conclusive evidence ...
6.1. List of excipients
Lactose monohydrate, maize starch, polyvidone 25000, talc, magnesium stearate, sucrose, polyvidone 700000, macrogol 6000, calcium carbonate, glycerol 85%, titanium dioxide (E171), ferric oxide yellow (E172), ...
6.2. Incompatibilities
None known.
6.3. Shelf life
The expiry date of the product is indicated on the packaging materials.
6.4. Special precautions for storage
Keep out of reach of children. Do not store above 25°C.
6.5. Nature and contents of container
Calendar pack containing 1 21 coated tablets (B).
7. Marketing authorization holder
Bayer Israel LTD, 36 Hacharash st., Hod Hasharon 4527702 Manufacturer: Bayer Weimar GMBH UND CO.KG, Dobereinerstrasse 20, Weimar 99427, Germany
8. Marketing authorization number(s)
032-90-22502-00
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