IMVAGGIS Pessary (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

IMVAGGIS 0.03 mg pessary.

2. Qualitative and quantitative composition

1 pessary contains 0.03 mg estriol. Excipient with known effect: Each pessary contains a maximum of 0.008 mg butylhydroxytoluene. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Pessary. White, homogenous pessaries.

4.1. Therapeutic indications

Local treatment of vaginal symptoms of estrogen deficiency in postmenopausal women.

4.2. Posology and method of administration

Posology During the first 3 weeks of treatment one pessary is administered daily. Thereafter a maintenance dose of 1 pessary twice a week is recommended. For initiation and continuation of treatment of ...

4.3. Contraindications

Known, past or suspected breast cancer. Known or suspected estrogen-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

Due to the vaginal administration and minimal systemic absorption, it is unlikely that any clinically relevant drug interactions will occur with IMVAGGIS 0.03 mg pessary. However interactions with other ...

4.6. Pregnancy and lactation

Pregnancy The use of IMVAGGIS 0.03 mg pessary is not indicated during pregnancy. If pregnancy occurs during medication with IMVAGGIS 0.03 mg pessary, treatment should be withdrawn immediately. The results ...

4.7. Effects on ability to drive and use machines

Treatment with IMVAGGIS 0.03 mg pessary has no influence on the ability to drive and use machines.

4.8. Undesirable effects

At the beginning of treatment, when the vaginal epithelial layers are still atrophic, local At the beginning of treatment, when the vaginal epithelial layers are still atrophic, local irritation may occur ...

4.9. Overdose

Toxicity for estriol is very low. Overdose of IMVAGGIS 0.03 mg pessary by vaginal application is very unlikely. Symptoms that may occur in the case of a high dose is accidentally ingested are nausea, vomiting ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: natural and semisynthetic estrogens, plain, ATC code: G03CA04 The active ingredient, semisynthetic estriol, is chemically identical to human estriol which is produced ...

5.2. Pharmacokinetic properties

Absorption and distribution A pharmacokinetic study was performed in postmenopausal women with diagnosed vaginal atrophy in order to investigate the extent of systemic exposure to estriol from IMVAGGIS ...

5.3. Preclinical safety data

The toxicological properties with estrogens are well known. Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity and carcinogenic ...

6.1. List of excipients

Butylhydroxytoluene Glycerolmono/bis [(Z-R)-12-hydroxyoctadec-9-enoate] Hard fat Macrogol cetostearyl ether

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

Aluminium/laminated PE strips with pessaries packed in a cardboard carton. Pack sizes with 10, 15, 20, 24 and 30 pessaries. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Besins Healthcare (UK) Ltd, Lion Court, 25 Procter Street, Holborn, London, WC1V 6NY, United Kingdom

8. Marketing authorization number(s)

PL 42714/0001

9. Date of first authorization / renewal of the authorization

15/03/2018

10. Date of revision of the text

January 2022

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