Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
pirlimycin
Zoetis Belgium SA
QJ51FF90
pirlimycin
Cattle
Antibacterials for intramammary use
For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.
Revision: 15
Authorised
2001-01-29
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: PIRSUE 5 MG/ML INTRAMAMMARY SOLUTION FOR CATTLE 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Norbrook Laboratories Limited Station Works, Camlough Road, Newry, County Down, BT35 6JP UNITED KINGDOM or Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml intramammary solution for cattle 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Pirlimycin (as Pirlimycin hydrochloride) 50 mg/10 ml 4. INDICATION(S) For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as _Staphylococcus aureus_ , both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including _Streptococcus agalactiae_ , _Streptococcus dysgalactiae_ , and _Streptococcus uberis. _ 5. CONTRAINDICATIONS Resistance against pirlimycin. Treatment of infections due to Gram-negative bacteria such as _E. coli_ . Do not treat cows with palpable udder changes due to chronic subclinical mastitis. 16 6. ADVERSE REACTIONS None known. If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Cattle (lactating dairy cows). 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramammary use. Infuse one syringe (50 mg pirlimycin) into each infected quarter. The treatment consists of eight infusions of one syringe every 24 hours. 9. ADVICE ON CORRECT ADMINISTRATION Care must be taken not to introduce pathogens into the teat in order to reduce the risk of _E. coli_ infections. Ensure adequate cleansing of t Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml intramammary solution for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Pirlimycin (as Pirlimycin hydrochloride) 50 mg/10 ml For the full list of excipients see Section 6.1 3. PHARMACEUTICAL FORM Intramammary solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (lactating dairy cows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as _Staphylococcus aureus_ , both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including _Streptococcus agalactiae_ , _Streptococcus dysgalactiae_ and _Streptococcus uberis._ 4.3 CONTRAINDICATIONS Resistance against pirlimycin. Treatment of infections due to Gram-negative bacteria such as _E. coli_ . Do not treat cows with palpable udder changes due to chronic subclinical mastitis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Susceptibility testing of the target bacteria should be carried out prior to treatment. _ _ Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid contact with the solution. Wash hands and any exposed skin with soap and water and remove contaminated clothing immediately after use. Flush eyes with water for 15 minutes immediately after exposure. Hold eyelids open to ensure complete contact with water. 3 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None known. 4.7 USE DURING PREGNANCY, LACTATION OR LAY The product is indicated for use in lactating dairy cows and can be used during pregnancy. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Cross-resistance may occur between pirlimycin and other lincosamides or macrolides. 4.9 AMOUNTS TO BE ADMINIS Aqra d-dokument sħiħ