SANDRENA Gel (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Sandrena 0.5 mg gel.
2. Qualitative and quantitative composition
Estradiol hemihydrate corresponding to 0.5 mg estradiol per single-dose container. <u>Excipient with known effect:</u> propylene glycol. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gel, single-dose container. Smooth, opalescent gel.
4.1. Therapeutic indications
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women. The experience of treating women more than 65 years old is limited.
4.2. Posology and method of administration
Posology Sandrena is a gel for transdermal use. Sandrena can be used for continuous or cyclical treatment. The usual starting dose is 1.0 mg estradiol (1.0 g gel) daily but the selection of the initial ...
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 ...
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 may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, ...
4.6. Pregnancy and lactation
Pregnancy Sandrena is not indicated during pregnancy. If pregnancy occurs during medication with Sandrena, treatment should be withdrawn immediately.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.
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. ...
4.9. Overdose
Generally, oestrogens are well tolerated even in massive doses. Acute toxicity studies did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic ...
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 The active ingredient in Sandrena, synthetic 17β-estradiol, ...
5.2. Pharmacokinetic properties
Sandrena is an alcohol-based estradiol gel. When applied to the skin the alcohol evaporates rapidly and estradiol is absorbed through the skin into the circulation. Application of Sandrena on area of 200-400 ...
5.3. Preclinical safety data
Estradiol is a natural female hormone with an established clinical use, therefore no toxicological studies have been performed with Sandrena. The necessary studies on the irritant effects of the gel were ...
6.1. List of excipients
Carbomer 974P Trolamine Propylene glycol Ethanol 96% Water, purified
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Single-dose aluminium foil container (PET/Aluminium/PE) supplied in packages containing 28 or 91 single-dose containers. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
8. Marketing authorization number(s)
PL 27925/0015
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 November 1996 Date of latest renewal: 31 March 2010
10. Date of revision of the text
29/06/2018
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