NYSTALOCAL Cream Ref.[28289] Active ingredients: Chlorhexidine Dexamethasone Nystatin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: ADL Pharmaceutical Products Ltd, 12 Agiou Spyridonos str., 7102 Aradippou, P.O. Box 40981, 6308 Larnaca, Cyprus, Tel.: 0035724667878

Product name and form

Nystalocal (100.000 I.U./1 mg/11.5 mg)/g cream.

Pharmaceutical Form

Cream.

Qualitative and quantitative composition

Each gram of cream contains 100.000 I.U. nystatin, 1 mg dexamethasone and 11.5 mg chlorhexidine dihydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Chlorhexidine

Chlorhexidine is an antimicrobial agent, active against a broad spectrum of Gram-positive and Gram-negative organisms, yeasts, fungi, opportunistic anaerobes and aerobes. Chlorhexidine is mainly a “membrane-acting” agent that destroys the outer membrane of the bacteria. It is inactive on bacterial spores unless the temperatures are high.

Dexamethasone

Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.

Nystatin

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.

List of Excipients

Macrogol 400
Macrogol 4000
Disodium edetate

Pack sizes and marketing

Pack with one tube of Nystalocal cream 20 g.

Marketing authorization holder

ADL Pharmaceutical Products Ltd, 12 Agiou Spyridonos str., 7102 Aradippou, P.O. Box 40981, 6308 Larnaca, Cyprus, Tel.: 0035724667878

Marketing authorization dates and numbers

014149

Date of first authorisation: 29 April 1993
Date of latest renewal: 18 November 2009

Drugs

Drug Countries
NYSTALOCAL Cyprus, Hong Kong

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