BETAISODONA Cream (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Trademark: BETAISODONA 5,0%w/w Cream. Generic (INN) Name: Povidone-Iodine.

2. Qualitative and quantitative composition

Povidone-Iodine Ph. Eur. 5.0% w/w. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Cream. For topical administration.

4.1. Therapeutic indications

BETAISODONA Cream is indicated in: Bacterial and Mycotic infections. Bed sore and varicose ulcers. Pyodermiae. Major and minor burns, cuts and abrasions.

4.2. Posology and method of administration

For topical use only. Posology The cream can be applied once or several times daily. Paediatric population BETAISODONA Cream is contraindicated in children below the age of 1 year (see section 4.3). Method ...

4.3. Contraindications

Contraindicated in: Hypersensitivity to iodine or povidone or any other of the excipients listed in section 6.1. Hyperfunction of the thyroid (hyperthyroidism), other manifest thyroid diseases, esp. nodular ...

4.4. Special warnings and precautions for use

Patients with goitre, thyroid nodules, or other non-acute thyroid diseases are at risk of developing thyroid hyperfunction (hyperthyroidism) from the administration of large amounts of iodine. In this ...

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

The PVP-Iodine complex is effective at pH values of between 2.0 and 7.0. It has to be expected that the complex will react with protein and other unsaturated organic compounds, leading to impairment of ...

4.6. Pregnancy and lactation

Povidone Iodine passes into the placenta and is secreted in breast milk. Thyroid function disorders including congenital hypothyroidism have been reported in the offspring of mothers who have received ...

4.7. Effects on ability to drive and use machines

BETAISODONA Cream has no influence on the ability to drive and use machines.

4.8. Undesirable effects

The following frequencies are the basis for assessing undesirable effects: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), ...

4.9. Overdose

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns or deliberate or accidental ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antiseptics ATC code: D08AG02 Povidone-Iodine is a complex of the polymer polyvinylpyrrolidone with iodine (Povidone-Iodine) which, after application, continues ...

5.2. Pharmacokinetic properties

Absorption In normal individuals, topical application results in very little systemic iodine absorption; with vaginal administration, however, iodine absorption is rapid and serum concentrations of total ...

5.3. Preclinical safety data

Acute toxicity In experimental animal investigations (mouse, rat rabbit, dog), acutely toxic effects were found after systemic administration (oral, i.p., i.v.) only with excessively high doses that are ...

6.1. List of excipients

Cetostearyl alcohol White soft paraffin Sodium hydroxide Liquid paraffin Glycerol Sorbitan stearate Macrogol stearate Polysorbate 60 Potassium iodate Purified water

6.2. Incompatibilities

Povidone-Iodine should not be used together with alkali, hydrogen peroxide, taurolidine, tannic acid, and silver and mercury salts.

6.3. Shelf life

36 months. Do not use after the expiry date (see date printed on the packing).

6.4. Special precautions for storage

Store at or below 25°C.

6.5. Nature and contents of container

Supplied in lacquered aluminium tubes, containing 5g, 15g or 40g of the product. The tubes are enclosed in printed cartons.

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

MUNDIPHARMA PHARMACEUTICALS LTD., 13, Othellos str., Dhali Industrial Zone, P.O. Box 23661, 1685 Nicosia, Cyprus Tel: +357 22815656 Fax: +357 22487833 e-mail: info@mundipharma.com.cy

8. Marketing authorization number(s)

14789

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 29 June 1994 Date of latest renewal: 22nd December 2014

10. Date of revision of the text

08/2021

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