VAGIRUX Vaginal tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Vagirux 10 micrograms vaginal tablets.
2. Qualitative and quantitative composition
Each vaginal tablet contains 10 micrograms estradiol (as estradiol hemihydrate). The diameter of the tablet is approximately 6 mm. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Vaginal tablet. White, round, film coated tablets embossed with E on one side.
4.1. Therapeutic indications
Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1). Vagirux may be used in women with or without an intact uterus. The experience treating women older than ...
4.2. Posology and method of administration
Posology Vaginal infections should be treated before start of the Vagirux therapy. Treatment may be started on any convenient day. Initial dose One vaginal tablet daily for two weeks. Maintenance dose ...
4.3. Contraindications
Known, past or suspected breast cancer; Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer); Undiagnosed genital bleeding; Untreated endometrial hyperplasia; Previous ...
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
Due to the vaginal administration and minimal systemic absorption, it is unlikely that any clinically relevant drug interactions will occur with Vagirux. However, interactions with other locally applied ...
4.6. Fertility, pregnancy and lactation
Pregnancy Vagirux is not indicated during pregnancy. If pregnancy occurs during medication with Vagirux, treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant ...
4.7. Effects on ability to drive and use machines
No effects known.
4.8. Undesirable effects
Adverse events from clinical trials More than 1100 patients have been treated with estradiol 10 micrograms vaginal tablets in clinical trials, including over 497 patients treated up to 52 weeks. Oestrogen-related ...
4.9. Overdose
Vagirux is intended for intravaginal use and the dose of estradiol is very low. Overdose is therefore unlikely, but if it occurs, treatment is symptomatic.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Natural and semisynthetic oestrogens, plain <b>ATC code:</b> G03CA03 The active ingredient, synthetic 17-beta-estradiol, is chemically and biologically identical to endogenous ...
5.2. Pharmacokinetic properties
Absorption Oestrogens are well absorbed through the skin, mucous membranes and the gastrointestinal tract. After vaginal administration, estradiol is absorbed circumventing first-pass metabolism. A 12-weeks, ...
5.3. Preclinical safety data
17-beta-estradiol is a well-known substance. Non-clinical studies provided no additional data of relevance to clinical safety beyond those already included in other sections of the SmPC.
6.1. List of excipients
<u>Tablet core:</u> Hypromellose Lactose monohydrate Maize starch Magnesium stearate <u>Film-coating:</u> Hypromellose Macrogol
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Vagirux tablets are packed in PVC/PVDC/aluminium blister packs. The blisters are packed into cardboard boxes accompanied by a multiple-use applicator sealed separately in foil. <u>Pack sizes:</u> 18 × ...
6.6. Special precautions for disposal and other handling
17-beta-estradiol is expected to pose a risk to the aquatic environment, especially to fish populations. See section 4.2 for instructions on cleaning and disposal of applicator device. Any unused medicinal ...
7. Marketing authorization holder
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
8. Marketing authorization number(s)
PL 04854/0184
9. Date of first authorization / renewal of the authorization
20/08/2020
10. Date of revision of the text
19/10/2020
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