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.

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.

1. TARGET SPECIES

   
   

   Cattle (lactating dairy cows).

   
   

2. 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.

   
   

3. 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 the teat (and udder - if needed) before infusion. The following instructions should therefore be followed carefully.

   Clean hands before handling the cow's udder. Wash the udder if it is dirty. Where necessary, wash the teats thoroughly with warm water containing a suitable dairy cleansing agent and dry them thoroughly. Disinfect teat end using a suitable cleansing agent. The teat end should be cleaned until no more dirt appears on the swab. Use a separate disinfectant towelette for each teat. Do not touch cleaned teat ends before administering the infusion substance.

   
   

   Insertion: Remove the white end cap by pulling straight up. Gently insert the cannula into the teat canal; carefully infuse the product.

   Push plunger with continuous pressure gently and slowly to dispense entire contents into the gland and massage the quarter to distribute the product into the milk cistern. Following infusion, dip all teats with a disinfectant teat dip.

   
   

   Susceptibility testing of the target bacteria should be carried out prior to treatment.

   
   

4. WITHDRAWAL PERIOD(S)

   
   

   Meat and offal: 23 days. Milk: 5 days.

   
   

5. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 25 °C. Keep the syringes in the original container.

Do not use this veterinary medicinal product after the expiry date which is stated on the label and the container.

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.

Cross-resistance may occur between pirlimycin and other lincosamides or macrolides.

1. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

   
   

   Medicines should not be disposed of via wastewater or household waste.

   Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

   
   

2. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

   
   

   ).

   
   

3. OTHER INFORMATION

Not all pack sizes may be marketed.