MYCOSTATIN Oral suspension (2021)
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Περιεχόμενα
1. Name of the medicinal product
Mycostatin 100,000 units/ml Oral Suspension (Ready Mixed).
2. Qualitative and quantitative composition
Ready mixed oral suspension containing 100,000 units nystatin per ml. <u>Excipient(s) with known effect:</u> Ethanol (8.06 mg/ml) Sucrose (500 mg/ml) Sodium (1 mg/ml) Methyl parahydroxybenzoate (E218, ...
3. Pharmaceutical form
Oral suspension. Light creamy, yellow suspension.
4.1. Therapeutic indications
The prevention and treatment of mycotic infections due to <em>Candida albicans</em>, affecting the oral cavity. Consideration should be given to official guidance on the appropriate use of antifungal agents. ...
4.2. Posology and method of administration
Posology Neonates (from birth to 1 month) Clinical studies of limited size in neonates, including preterm and babies of low weight at birth, indicate that 1 ml (100,000 U) three times daily is an effective ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Mycostatin Oral Suspension should not be used for treatment of systemic mycoses. In the therapy of Candidal infections, all potential sites of infections should be treated simultaneously. This medicine ...
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
Pregnancy Animal reproductive studies have not been conducted with nystatin. It is not known whether nystatin can cause foetal harm when administered to a pregnant woman or can affect reproductive capacity, ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Nystatin is generally well tolerated by all age groups, even during prolonged use. If irritation or sensitisation develops, treatment should be discontinued. The table below lists all adverse events. The ...
4.9. Overdose
Since the absorption of nystatin from the gastro-intestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity. Oral doses of nystatin in excess of 5 million units daily ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antifungals for topical use <b>ATC code:</b> D01AA01 Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including <em>Candida ...
5.2. Pharmacokinetic properties
Absorption Nystatin is formulated in oral and topical dosage forms and is not systemically absorbed from any of these preparations. Gastrointestinal absorption of nystatin is insignificant. Elimination ...
5.3. Preclinical safety data
No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effect on male or female ...
6.1. List of excipients
Cherry flavour Cinnamic aldehyde Ethanol Glycerol Methyl parahydroxybenzoate (E218) Peppermint oil pH adjusters (hydrochloric acid, sodium hydroxide) Propyl parahydroxybenzoate (E216) Sodium carboxymethycellulose ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C. Do not freeze. Store in the original container.
6.5. Nature and contents of container
30 ml Type III amber glass bottle with polypropylene cap, packed in a cardboard carton with a graduated, polyethylene dropper with natural rubber bulb.
6.6. Special precautions for disposal and other handling
Shake well before use. Dilution is not recommended as this may reduce therapeutic efficacy. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. ...
7. Marketing authorization holder
Substipharm, 24 rue Erlanger, 75016 Paris, France
8. Marketing authorization number(s)
PA1677/007/007
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1977 Date of last renewal: 01 April 2007
10. Date of revision of the text
January 2021
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