PROGYNOVA Transdermal patch (2021)
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Περιεχόμενα
1. Name of the medicinal product
Progynova TS 50 micrograms/24 hours Transdermal Patch.
2. Qualitative and quantitative composition
Each 12.5 cm² patch contains 3.8 mg estradiol (formed from 3.9 mg estradiol hemihydrate), releasing a nominal 50 micrograms of estradiol per 24 hours. For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Transdermal patch. Oval transdermal patch with a translucent homogenous matrix on a transparent carrier film.
4.1. Therapeutic indications
Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause. Prevention of osteoporosis in postmenopausal women at high risk of future fractures ...
4.2. Posology and method of administration
Posology Progynova TS 50 is an oestrogen-only patch applied to the skin once weekly. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest ...
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 or current ...
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
Note: The prescribing information of concomitant medication should be consulted to identify potential interactions. Effects of other medicinal products on Progynova TS <u>Substances increasing the clearance ...
4.6. Pregnancy and lactation
Pregnancy Progynova TS is not indicated during pregnancy. If pregnancy occurs during medication with Progynova TS treatment should be withdrawn immediately. The results of most epidemiological studies ...
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 TS.
4.8. Undesirable effects
During the first few months of treatment, breakthrough bleeding, spotting and breast tenderness or enlargement can occur. These are usually temporary and normally disappear after continued treatment. The ...
4.9. Overdose
Overdosage is unlikely with this type of application. Nausea, vomiting and withdrawal bleeding may occur in some women. There is no specific antidote and treatment should be symptomatic. The patch(es) ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Natural and semisynthetic oestrogens, plain <b>ATC code:</b> G03CA03 Mechanism of action and pharmacodynamic effects Progynova TS contains synthetic 17ß-estradiol, which ...
5.2. Pharmacokinetic properties
Absorption After dermal application of Progynova TS, estradiol is continuously released and transported across intact skin leading to sustained circulating levels of estradiol during a 7-day treatment ...
5.3. Preclinical safety data
The toxicity profile of estradiol is well known. There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. In primary dermal ...
6.1. List of excipients
Isooctyl acrylate/acrylamide/vinyl acetate copolymer Ethyl oleate Isopropyl myristate Glycerol monolaurate Polyester release liner Polyethylene backing film
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 30°C. Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
Each patch is sealed in a multilaminate pouch containing a desiccant. The desiccant consists of sodium alumino silicate; Pack of 4 or 12 patches. (Not all pack sizes may be marketed).
6.6. Special precautions for disposal and other handling
After use the patch still contains substantial quantities of estradiol, which may have harmful effects if reaching the aquatic environment. Therefore, the used patch should be discarded carefully. Any ...
7. Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
8. Marketing authorization number(s)
PL 00010/0560
9. Date of first authorization / renewal of the authorization
11 July 2010
10. Date of revision of the text
06 April 2021
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