Zinerit powder for preparation of solution for external use bottle with applicator with solvent in a bottle 30 ml No. 1

Instructions Zinerit powder for preparation of solution for external use bottle with applicator with solvent in a bottle 30 ml No. 1

Composition

active ingredients: erythromycin, zinc acetate;

1 ml of the prepared solution contains erythromycin 40 mg and zinc acetate dihydrate, micronized 12 mg;

excipients (solvent): diisopropyl sebacate, anhydrous ethanol.

Dosage form

Powder for preparation of solution for external use, complete with solvent and applicator.

Main physicochemical properties: white powder; solvent – clear, colorless liquid.

Pharmacotherapeutic group

Antimicrobial agent for the treatment of acne. ATX code D10A F52.

Pharmacological properties

Pharmacodynamics

Zinerit® is an erythromycin-zinc complex. It has anti-inflammatory, antimicrobial and comedonolytic effects. Erythromycin has a bacteriostatic effect on microorganisms that cause acne: Propionibacterium acne and Streptococcus epidermidis. Zinc reduces the production of sebaceous gland secretions and has an astringent effect.

Pharmacokinetics

The complex relationship of the drug components ensures good penetration of active substances into the skin. Zinc mainly binds to the follicular epithelium and is not absorbed into the systemic circulation. A small part of erythromycin undergoes systemic distribution and is subsequently excreted from the body.

Indication

Treatment of acne.

Contraindication

Zinerit® is contraindicated in patients with hypersensitivity to erythromycin or other macrolide antibiotics or to zinc, diisopropyl sebacate, ethanol.

Interaction with other medicinal products and other types of interactions

No interactions with other drugs have been established to date.

Application features

Zinerit® is intended exclusively for the treatment of the skin; contact with the eyes and mucous membranes of the nose and mouth should be avoided.

Cross-resistance may occur with other macrolide antibiotics and with lincomycin and clindamycin. Cross-resistance may occur between macrolides.

Use during pregnancy or breastfeeding

Pregnancy.

Data from use during pregnancy do not indicate any harmful effects of erythromycin on pregnancy or the baby. Erythromycin can be used during pregnancy.

Lactation.

Only a small amount of erythromycin passes into breast milk, so it can be used during lactation.

Fertility.

The fertility data doesn't show anything special.

Ability to influence reaction speed when driving vehicles or other mechanisms

There is no data on the effect of Zinerit® on the ability to drive or operate machinery. However, any effect is unlikely.

Method of administration and doses

Method of application.

When starting treatment, the liquid from the solvent vial should be poured into the powder vial. After that, the vial should be shaken until the powder dissolves, and then closed with the cap with the applicator provided.

Instructions for preparing Zinerit® solution.

1. The package contains two vials (vial A and B) and one applicator.

Open the caps from both vials. Save the cap from vial A, which contains the powder.

2. Transfer the solvent from vial B into vial A, which contains the powder. Empty vial B can be discarded.

3. Close vial A, which contains the powder and solvent, using the cap that was left.

4. Shake vial A immediately for 1 minute.

5. Remove the cap from bottle A and attach the applicator.

6. Push the cap containing the applicator into the full bottle and close tightly.

7. Now you can open the cap from the bottle and check that the applicator is securely held. If necessary, press firmly on the applicator.

8. The solution is stable for 5 weeks after preparation. Mark the expiration date on the bottle.

Zinerit® should be applied in a thin layer to the skin of the face or affected areas (not just the affected area itself) until the entire area to be treated is covered (approximately 0.5 ml of the medicine should be used each time).

Zinerit® is applied by tilting the bottle with the applicator down so that the applicator is against the skin, and rubbing the skin with the applicator with light pressure. The amount of Zinerit® is regulated by the force of pressure.

Dosage. Zinerit® should be used 2 times a day, usually for 10-12 weeks. A noticeable therapeutic effect is usually achieved within the first 12 weeks. If during this period no noticeable improvement is achieved or even a deterioration in the condition is observed, the patient should consult a doctor for examination regarding the possibility of bacterial microflora resistance. If bacterial microflora resistance occurs, the use of the drug should be discontinued for 2 months.

Children

The drug can be used in children aged 12 years and older due to clinical studies conducted in children who have reached puberty.

Overdose

Taking into account the pharmaceutical form, accidental overdose is unlikely.

Acute poisoning with a single oral administration of the entire contents of a package of Zinerit® will generally result in symptoms of a short-term toxic effect due to the pure alcohol content of the drug.

Side effects

*Erythema, skin irritation, and burning sensation are temporary and minor clinical signs.

Expiration date

2 years.

Storage conditions

Store at a temperature not exceeding 25 °C, out of the reach of children.

The ready-to-use solution can be stored for 5 weeks at a temperature not exceeding 25 ° C. If further treatment with Zinerit® is necessary, a new package should be purchased.

Packaging

Plastic bottle "A" with powder for preparing a solution for external use, plastic bottle "B" with solvent and applicator (cap for preparing the dosage form and dosing the resulting solution) in a cardboard box with instructions for medical use.

Vacation category

Without a prescription.

Producer

LEO Pharma A/S, Denmark.

Address

Industriparken 55, Ballerup, 2750, Denmark.