Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Erythromycin
Ceva Santé Animale
QJ01FA01
Erythromycin
16.5 percent weight/weight
Powder for oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
erythromycin
Authorised
1988-10-01
Health Products Regulatory Authority 25 March 2019 CRN008YLP Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Erythrocin 16.5 % w/w Soluble Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g of powder contains: Active substance Erythromycin 16.5 % w/w as erythromycin thiocyanate Excipients Amaranth (E123) 0.35 % w/w For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of chronic respiratory disease caused by Mycoplasma infection where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates Erythromycin as the drug of choice. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active ingredient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. The water system to which the product is added must be in good working order and the header tanks and troughs must be free of dust, algae or other particulate matter. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS None. Health Products Regulatory Authority 25 March 2019 CRN008YLP Page 2 of 4 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None known. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Not applicable. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known. 4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE For oral administration via th Preberite celoten dokument