ROZEX Cream (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Rozex 0.75% w/w Cream.
2. Qualitative and quantitative composition
Metronidazole 0.75% w/w. <u>Excipients with known effect:</u> Cetostearyl alcohol (100mg/g). One gram of cream contains 22 mg of benzyl alcohol (E1519). For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Cream.
4.1. Therapeutic indications
Rozex cream is indicated in the treatment of inflammatory papules, pustules and erythema of rosacea.
4.2. Posology and method of administration
Posology This medicinal product is for topical administration only. The average period of treatment is three to four months. The recommended duration of treatment should not be exceeded. However, if a ...
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
Contact with mucous membranes should be avoided. Rozex Cream has been reported to cause lacrimation of the eyes, therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation ...
4.5. Interaction with other medicinal products and other forms of interaction
Interaction with systemic medication is unlikely because absorption of metronidazole following cutaneous application of Rozex Cream is low. Nevertheless, it should be mentioned that disulfiram-like reactions ...
4.6. Pregnancy and lactation
Pregnancy There is no experience to date with the use of Rozex Cream in pregnancy. In case of oral administration, metronidazole crosses the placental barrier and rapidly enters the foetal circulation. ...
4.7. Effects on ability to drive and use machines
Rozex Cream has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Because of the minimal absorption of metronidazole and consequently its insignificant plasma concentration after topical administration, the adverse experiences reported with the oral form of the drug ...
4.9. Overdose
No data exists about overdosage in humans. Acute oral toxicity studies with a topical gel formulation containing 0.75% w/w metronidazole in rats have shown no toxic action with doses of up to 5 g of finished ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Chemotherapeutics for external use <b>ATC code:</b> D06BX01 Metronidazole is an antiprotozoal and antibacterial agent which is active against a wide range of pathogenic ...
5.2. Pharmacokinetic properties
Absorption Metronidazole is rapidly and nearly totally absorbed after oral administration. The drug is not significantly bound to serum proteins and distributes well to all body compartments with the lowest ...
5.3. Preclinical safety data
No evidence for a primary dermal irritation was observed in rabbits following a single 24-hour cutaneous application of Rozex Cream to abraded and non-abraded skin, under occlusion. Metronidazole has shown ...
6.1. List of excipients
Emulsifying wax (cetostearyl alcohol and polysorbate-60) Benzyl alcohol (E1519) Isopropyl palmitate Glycerol Sorbitol 70% (non-crystallising) lactic acid and/or sodium hydroxide (for pH adjustment) Purified ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Do not refrigerate.
6.5. Nature and contents of container
Aluminium tubes with epoxy phenolic lining, fitted with white polypropylene screw caps; pack sizes: 30g, 40g & 50g Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Replace cap tightly after use. No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Galderma (UK.) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK
8. Marketing authorization number(s)
PL 10590/0028
9. Date of first authorization / renewal of the authorization
18<sup>th</sup> June 1997
10. Date of revision of the text
8 September 2021
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