ZINERYT Powder and solvent for solution (2022)
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Περιεχόμενα
1. Name of the medicinal product
Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution.
2. Qualitative and quantitative composition
Erythromycin-zinc complex containing the equivalent of 40 mg/ml erythromycin and 12 mg/ml zinc acetate dihydrate (as the complex) on constitution. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for cutaneous solution. The packaging contains a bottle of powder, a bottle of solvent and an applicator in a plastic holder.
4.1. Therapeutic indications
Zineryt is indicated in children, adults and the elderly. It is used as topical treatment of acne vulgaris.
4.2. Posology and method of administration
For cutaneous use. Apply twice daily over the whole of the affected area for a period of 10 to 12 weeks.
4.3. Contraindications
Hypersensitivity to the active substance(s), to other macrolide antibiotics, or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Zineryt can be used during pregnancy and during breast-feeding (but it should not be used on the chest).
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
Tabulated list of adverse reactions System Organ Class Rare (≥1/10,000 to <1/1000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) <b>Immune system disorders</b> ...
4.9. Overdose
It is not expected that overdosage would occur in normal use. Patients showing idiosyncratic hypersensitivity should wash the treated area with copious water and simple soap.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anti-acne <b>ATC code:</b> D10AF52 Erythromycin is known to be efficacious, at 4%, in the topical treatment of acne vulgaris. Zinc, topically, is established as an aid ...
5.2. Pharmacokinetic properties
Absorption The complex does not survive in the skin, and erythromycin and zinc penetrate independently. The erythromycin penetrates, and is partially systemically absorbed (0-10% in vitro, 40-50% in animal ...
5.3. Preclinical safety data
Non-clinical data from repeated dose toxicity and reproduction and developmental toxicity studies reveal no additional hazard other than those described elsewhere in the SPC.
6.1. List of excipients
Diisopropyl sebacate Ethanol
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years. 8 weeks after constitution.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Screw-capped HDPE bottles; an applicator assembly is fitted when dispensed. When constituted packs are of 30 ml and 90 ml.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
8. Marketing authorization number(s)
PL 45043/0097
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 07 March 1990 Date of latest renewal: 19 December 2008
10. Date of revision of the text
04/03/2022
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