Zineryt

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

erythromycin 40 mg/ml

Available from:

Astellas Pharma Europe B.V.

ATC code:

D10AF52

INN (International Name):

erythromycin

Pharmaceutical form:

powder and solvent for cutaneous solution

Authorization status:

Authorised

Authorization date:

2005-10-07

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT 

Zineryt® 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Zineryt contains erythromycin-zinc complex containing the equivalent
of 40 mg/ml erythromycin 
and 12mg/ml zinc acetate (as the complex) on reconstitution. 

3. PHARMACEUTICAL FORM 

Cutaneous solution (powder for the preparation of). 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Topical treatment of all forms of acne vulgaris. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

Dosage 

Zineryt should be applied twice daily to the affected skin, usually
for a period of 10 - 12 weeks. A 
considerable therapeutic effect is usually obtained within the first
12 weeks. 
If there has been no or insufficient improvement or even
deterioration after this period, the patient 
should consult his doctor and the possibility of bacterial resistance
should be considered. If 
bacterial resistance has occurred, use of the product should be
interrupted for a period of two 
months. 

Method of administration 

Zineryt should be applied liberally onto the skin of the entire
face or onto other affected areas 
(not only onto the lesion itself), until the entire area to be
treated is covered (approximately 0.5 
ml is required each time the product is applied). 

Zineryt is applied by tilting the bottle upside down with the
applicator against the skin and 
rubbing the applicator over the skin while
gently applying pressure. The amount of Zineryt 
released can be controlled by increasing or decreasing the
pressure of the applicator against the 
skin. 

4.3 CONTRAINDICATIONS 

Zineryt is contraindicated in patients who are hypersensitive to
erythromycin or other macrolide 
antibiotics, or to zinc, diisopropyl sebacate or ethanol. 

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Zineryt is indicated solely for topical treatment of the skin and
must not come into contact with 
t