NYSTALOCAL Cream (2020)
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Περιεχόμενα
1. Name of the medicinal product
Nystalocal (100.000 I.U./1 mg/11.5 mg)/g cream.
2. 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.
3. Pharmaceutical form
Cream.
4.1. Therapeutic indications
Nystalocal cream is indicated for the treatment of exudative inflammatory skin diseases which are microbiologically super infected particularly by Candida sp., such as diaper dermatitis, balanitis, vulvitis, ...
4.2. Posology and method of administration
Posology Nystalocal cream is applied in a thin layer 2 to 3 times a day to skin and mucus membranes. Paediatric population Special caution should be exercised when applying to infants and children (see ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. As all local corticosteroid preparations, Nystalocal is not indicated in skin infections of bacterial origin ...
4.4. Special warnings and precautions for use
Nystalocal cream should not be applied to open wounds. Generally special caution is required when Nystalocal cream is applied to large areas or for prolonged time (especially in infants). If possible, ...
4.5. Interaction with other medicinal products and other forms of interaction
Interactions with other medicinal products are not known.
4.6. Fertility, pregnancy and lactation
Pregnancy There are no controlled clinical studies with pregnant women. As the majority of glucocorticoids, dexamethasone has teratogenic effect. Nystalocal should not be used during pregnancy unless explicitly ...
4.7. Effects on ability to drive and use machines
No studies have been performed.
4.8. Undesirable effects
Skin disorders Local undesirable effects such as skin irritation, burning, purities and dryness as well as hypersensitivity reactions towards one of the ingredients of the preparation can occur particularly ...
4.9. Overdose
The clinical manifestations of Nystalocal overdosage correspond to the known overdosage of corticosteroids. The manifestations mentioned under the paragraph Undesirable effects may occur more frequently. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Corticosteroids, moderately potent, other combinations <b>ATC code:</b> D07XB05 Nystatin has fungistatic and fungicidal properties. The growth of susceptible fungi species ...
5.2. Pharmacokinetic properties
Locally applied, nystatin and chlorhexidine are absorbed only to a lower extent by the intact skin and mucus membrane. Detailed data on absorption and pharmacokinetic do not exist. The grade of penetration ...
5.3. Preclinical safety data
Dexamethasone is teratogenic in animal tests and mutagenic in various test systems. Nystatin has mutagenic properties. There is no conclusive data available on the carcinogenicity of the three components. ...
6.1. List of excipients
Macrogol 400 Macrogol 4000 Disodium edetate
6.2. Incompatibilities
Chlorhexidine can be inactivated by tensides. Nystatin is inactivated by magnesium and calcium ions, fatty acids, cystein, glutathione, sodium thioglyconate, glucose, lactose, phosphoric buffer and serum ...
6.3. Shelf life
21 months.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Pack with one tube of Nystalocal cream 20 g.
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
ADL Pharmaceutical Products Ltd, 12 Agiou Spyridonos str., 7102 Aradippou, P.O. Box 40981, 6308 Larnaca, Cyprus, Tel.: 0035724667878
8. Marketing authorization number(s)
014149
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 29 April 1993 Date of latest renewal: 18 November 2009
10. Date of revision of the text
11/2020
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