ZORAC Gel (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
ZORAC 0.05%, gel.
Qualitative and quantitative composition
Active substance: Tazarotene 0.05g. Excipients with known effect: Butylhydroxyanisole: 0.05g Butylhydroxytoluene: 0.05g For 100g of gel. For the full list of excipients, see section 6.1.
Pharmaceutical form
Gel. Colourless to light yellow, translucent to homogeneous cloudy gel.
Therapeutic indications
ZORAC gel is indicated for the topical treatment of mild to moderate plaque psoriasis involving up to 10% body surface area.
Posology and method of administration
Posology ZORAC gel is available in two concentrations. To initiate a treatment with ZORAC, it is advisable to start with ZORAC 0.05% in order to evaluate the skin response and tolerance before progressing ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Pregnancy (see section 4.6) Women planning a pregnancy Breast-feeding mothers Since there is, as yet, no clinical ...
Special warnings and precautions for use
Care should be taken to ensure that ZORAC is applied only to psoriatic lesions, as application to normal, eczematous or inflamed skin or skin affected by other pathologies may cause irritation. Patients ...
Interaction with other medicinal products and other forms of interaction
Concomitant use of pharmaceutical and cosmetic preparations which cause irritation or have a strong drying effect should be avoided.
Fertility, pregnancy and lactation
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The frequency of adverse reactions arising from clinical experience is given. The frequency is defined as follows: Very Common (≥ 1/10); Common (≥ 1/100 to <1/10); Uncommon (≥ 1/1,000 to <1/100); Rare ...
Overdose
Excessive dermal use of ZORAC may result in marked redness, peeling, or local discomfort. Inadvertent ingestion of ZORAC is a theoretical possibility. In such a case, the signs and symptoms associated ...
Pharmacodynamic properties
Pharmacotherapeutic group: TOPICAL ANTIPSORIATIC AGENT ATC-code: D05AX05 Both gels have demonstrated therapeutic effects as early as 1 week after commencement of a course of treatment. A good clinical ...
Pharmacokinetic properties
General characteristics Absorption Results of a pharmacokinetic study of single topical application of 0.1% <sup>14</sup>C-tazarotene gel show that approximately 5% is absorbed when applied to normal skin ...
Preclinical safety data
Subacute / Chronic toxicity The safety of daily dermal application of tazarotene gel was tested in mouse, rat and mini-pig over periods of up to one year. The main observation was reversible skin irritation. ...
List of excipients
Benzyl alcohol Macrogol 400 Hexylene glycol Carbomer 974P Trometamol Poloxamer 407 Polysorbate 40 Ascorbic acid Butylhydroxyanisole (E320) Butylhydroxytoluene (E321) Disodium edetate Purified water
Incompatibilities
Tazarotene is susceptible to oxidising agents and may undergo ester hydrolysis when in contact with bases.
Shelf life
3 years. After first opening of the container: 6 months.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
10g, 15g, 30g, 50g, 60g and 100g in tube (aluminium, internally lacquered epoxyphenolic) with white polypropylene cap. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, County Mayo, Ireland
Marketing authorization number(s)
PL 41443/0003
Date of first authorization / renewal of the authorization
30th July 1997 / 3rd December 2006
Date of revision of the text
July 2018
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