LENZETTO Transdermal spray, solution (2020)
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Περιεχόμενα
1. Name of the medicinal product
Lenzetto 1.53 mg/spray, transdermal spray, solution.
2. Qualitative and quantitative composition
Each spray delivers 90 microliter of transdermal spray, solution containing 1.53 mg of estradiol (equivalent to 1.58 mg of estradiol hemihydrate). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal spray, solution. The solution is clear, colourless to pale yellow.
4.1. Therapeutic indications
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women (in women at least 6 months since last menses or surgical menopause, with or without a uterus). The experience ...
4.2. Posology and method of administration
Posology Lenzetto is administered once daily, either as a monotherapy or as a continuous sequential treatment (when combined with a progestogen). One metered-dose spray is administered once daily to the ...
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 Lenzetto is not indicated during pregnancy. If pregnancy occurs during medication with Lenzetto treatment should be withdrawn immediately.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 of the effects of Lenzetto on the ability to drive and use machines have been performed.
4.8. Undesirable effects
In a 12-week, randomised, placebo-controlled trial of Lenzetto in 454 women, 80-90% of women who were randomised to active substance received at least 70 days of therapy and 75-85% of the women who were ...
4.9. Overdose
Effects have not been reported following acute ingestion of large doses of oestrogen-containing products. Overdosage of oestrogen may cause nausea and vomiting, breast tenderness, dizziness, abdominal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Sex hormones and modulators of the genital system, Oestrogens, Natural and semisynthetic oestrogens, plain; Estradiol <b>ATC Code:</b> G03CA03 Lenzetto provides systemic ...
5.2. Pharmacokinetic properties
Absorption When Lenzetto was applied to the skin, the average drying time was 90 sec (median = 67 sec). In a multiple-dose study, postmenopausal women were treated for 14 days with one-, two- or three-90 ...
5.3. Preclinical safety data
Conventional studies of general toxicity data revealed no additional risks in addition to what has already been reflected in the SmPC. Long-term continuous administration of natural and synthetic oestrogens ...
6.1. List of excipients
Octisalate Ethanol 96%
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. Use within 56 days of first use.
6.4. Special precautions for storage
Do not refrigerate or freeze. Do not store above 25°C. Contains ethanol which is flammable. Store away from heaters, open flames, and other sources of ignition.
6.5. Nature and contents of container
The solution is packaged in a glass vial fitted with a metered dose pump. The unit is encased in a plastic housing with a conical bell opening that controls the distance, angle, and area of application ...
6.6. Special precautions for disposal and other handling
After delivery of 56 sprays, the container must be discarded even if there is some leftover solution in it. The number of sprays made should be marked using the table on the carton. As drug residue will ...
7. Marketing authorization holder
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
8. Marketing authorization number(s)
PL 04854/0130
9. Date of first authorization / renewal of the authorization
13/08/2015
10. Date of revision of the text
31/10/2020
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