ESTRADERM Transdermal patch (2020)
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Περιεχόμενα
1. Name of the medicinal product
Estraderm MX 25.
2. Qualitative and quantitative composition
The active ingredient is estra-1, 3,5(10)-triene-3,17β-diol (oestradiol hemihydrate). Patches contain 0.75 mg active substance corresponding to a surface area of 11cm². For a full list of excipients, see ...
3. Pharmaceutical form
Estraderm MX is a square-shaped, self-adhesive, transparent, transdermal patch for application to the skin surface. Each patch comprises an impermeable polyester backing film, an adhesive matrix containing ...
4.1. Therapeutic indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women[at least 6 months since last menses]. Prevention of osteoporosis in postmenopausal women at high risk of future ...
4.2. Posology and method of administration
Estraderm MX 25 is an oestrogen only patch. In women with an intact uterus oestrogen should be supplemented by sequential administration of a progestagen (e.g. medroxyprogesterone acetate 10mg, norethisterone ...
4.3. Contraindications
Estraderm MX should not be used by women with any of the following conditions: Known, past or suspected breast cancer; Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer); ...
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 Estraderm MX is not indicated during pregnancy. If pregnancy occurs during medication with Estraderm MX treatment should be withdrawn immediately. The results of most epidemiological studies ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Adverse drug reactions from multiple sources including clinical trials and post-marketing experience (Table 1) are listed according to the system organ class in MedDRA. Within each system organ class, ...
4.9. Overdose
This is not likely due to the mode of administration. Signs and Symptoms Signs of acute oestrogen overdosage may be either one of, or a combination of, breast discomfort, fluid retention and bloating or ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> oestrogens <b>ATC code:</b> G03CA03 The active ingredient, synthetic 17β-estradiol is chemically and biologically identical to endogenous human estradiol. It substitutes ...
5.2. Pharmacokinetic properties
Absorption Steady-state serum oestradiol concentrations are reached within 8 hours after application of Estraderm MX 50 to the skin, and remain stable during 4 days. The mean E2 concentration during steady-state ...
5.3. Preclinical safety data
Animal studies with oestradiol have only shown effects which can be expected from an estrogenic substance. Acute toxicity of oestrogens is low. Because of marked differences between animal species and ...
6.1. List of excipients
Acrylate, methacrylate, isopropyl palmitate, polyethylene terephthalate, ethylenevinylacetate copolymer, silicone coating (on the inner side of the protective release liner which is removed before patch ...
6.2. Incompatibilities
None known.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store below 25°C. Keep out of the reach of children both before and after use.
6.5. Nature and contents of container
Each system is individually heat sealed in a paper/aluminium/polyethylene foil pouch. Eight or twenty four Estraderm MX pouches are placed in an appropriately sized carton which comprises the finished ...
6.6. Special precautions for disposal and other handling
See Section 4.2. Exposure of Estraderm MX patches to ultra-violet light results in degradation of oestradiol. Patches should not be exposed to sunlight. They should be applied immediately after removal ...
7. Marketing authorization holder
Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK
8. Marketing authorization number(s)
Estraderm MX 25: PL 20011/0064
9. Date of first authorization / renewal of the authorization
12 September 1997 / 10 February 2009
10. Date of revision of the text
08/2020
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