Valsts: Armēnija
Valoda: angļu
Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
erythromycin
Arpimed LLC
D10AF02
erythromycin
20mg/ml
solution for topical use
30ml glass bottle
Prescription
Registered
2018-08-07
SUMMARY OF PRODUCT CHARACTERISTICS ERYTHROMYCIN 2% SOLUTION FOR TOPICAL USE 1.1 BRAND NAME – Erythromycin 1.2 INTERNATIONAL NON-PROPERTY NAME – Erythromycin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains: Active ingredient: erythromycin – 20 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for topical use. A transparent, odorless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Erythromycin is indicated for use in the treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION • ADULTS AND ADOLESCENTS To be applied in a thin film to the affected area twice daily after washing and drying the skin. Hands should be washed after application. Patients should be advised that a therapeutic effect may not be seen until after 6-8 weeks of treatment. Treatment may be continued for up to a maximum of 6 months. If there has been no improvement after 6 to 8 weeks, or if the condition becomes worse, treatment should be discontinued. Owing to the flammable nature of the product, Erythromycin solution should be kept away from open fire and flames and all sources of ignition, including smoking, during and immediately after use. • PAEDIATRIC POPULATION Safety and effectiveness of topical erythromycin in children under the age of 12 have not been established. • ELDERLY There are no specific recommendations for use in the elderly. • RENAL IMPAIRMENT No dosage adjustment is necessary. • HEPATIC IMPAIRMENT No dosage adjustment is necessary. 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 Erythromycin should be used with caution in patients with a known sensitivity or allergy to any ingredients. Erythromycin contains propylene glycol which may cause skin irritation. Concomitant topical acne therapy should be used with caution because a cumulative irritancy effect may occur, especially with the use of peeling, desquamating or abrasive agents. I Izlasiet visu dokumentu