POLYGYNAX Vaginal capsule (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

POLYGYNAX, vaginal capsule.

2. Qualitative and quantitative composition

Neomycin sulfate 35 000 I.U. Polymyxin B sulfate 35 000 I.U. Nystatin 100 000 I.U. For one vaginal capsule. Excipient with known effect: Hydrogenated soybean oil. For the full list of excipients, ...

3. Pharmaceutical form

Vaginal capsule.

4.1. Therapeutic indications

Local treatment of vaginitis due to sensitive germs (bacterial vaginitis, vulvo-vaginitis due to Candida albicans and Candida non-albicans, mixed vaginitis) and treatment of ...

4.2. Posology and method of administration

Posology FOR ADULTS ONLY One vaginal capsule in the evening for 12 days. Method of administration Introduce one capsule deep in the vagina, preferably in lying down position. Practical advices: ...

4.3. Contraindications

This medicinal product is contraindicated in the following situations: Hypersensitivity to the active substances or to any excipients listed in section 6.1 (or group sensitivity), In case of use of diaphragms ...

4.4. Special warnings and precautions for use

Warnings In the event of local intolerance or allergic reaction, the treatment must be interrupted. The sensitisation to antibiotics by local route may compromise its later use of the same antibiotic or ...

4.5. Interaction with other medicinal products and other forms of interaction

Contraindicated combinations + Condoms and Diaphragms (latex) Risk of rupture. Combinations not recommended: + Spermicide Any local vaginal treatment is likely to inactivate a spermicidal ...

4.6. Pregnancy and lactation

Ph3. regnancy Due to the presence of an aminoside, neomycin, causing an ototoxic risk, and the possibility of systemic absorption, the use of this medicinal product is not recommended during pregnancy. ...

4.7. Effects on ability to drive and use machines

Not relevant.

4.8. Undesirable effects

Adverse reactions are classified by system organ class. For adverse reactions reported from spontaneous notifications, their frequency is not known (cannot be estimated from the available data). System ...

4.9. Overdose

An excessive and prolonged administration could induce systemic effects (hearing and renal), in particular in patients with renal insufficiency. A prolonged use also exposes to an increased risk of allergic ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: ANTIINFECTIVES and ANTISEPTICS IN GYNECOLOGICAL USE (G. genitourinary system and sex hormones) ATC code: G01AA51 Combination of neomycin, polymyxin B and nystatin. ...

5.2. Pharmacokinetic properties

There is no systemic absorption when the product is administered by vaginal route.

5.3. Preclinical safety data

Local tolerance in animals with Polygynax does not show any harmful effect on the vaginal mucosa. Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with ...

6.1. List of excipients

PEG-6 stearate and glycol stearate and PEG-32 stearate (Tefose 63), hydrogenated soybean oil, dimeticone 1000. Composition of the shell soft capsule: gelatine, glycerol, dimeticone 1000.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Capsules under blister (PVC/PVDC/aluminium): 2 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Box of 1 or 2 blisters (PVC/PVDC/Aluminium) of 6 capsules. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

LABORATOIRE INNOTECH INTERNATIONAL, 22 AVENUE ARISTIDE BRIAND, 94110 ARCUEIL

8. Marketing authorization number(s)

MA093/00401

9. Date of first authorization / renewal of the authorization

02nd January 2007 / 22nd November 2018

10. Date of revision of the text

21st July 2020

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