Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Sterile, intramammary solution presented in plastic syringes with Flexi-Tube™ for intramammary infusion. Each 10 ml syringe contains Pirlimycin Hydrochloride equivalent to 50 mg pirlimycin.

Uses

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.

Dosage and administration

By intramammary infusion only.

Infuse one syringe (50 mg pirlimycin) with applicator (Flexi-Tube™) into each infected quarter. The treatment consists of eight infusions of one syringe every 24 hours.

Preparation: 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 udder if it is dirty. Where necessary, wash 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 infusion substance.

Infusion: Care should be taken to avoid contamination of the syringe injector nozzle. 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 disperse 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.

Contra-indications, warnings, etc

Do not use in animals with known hypersensitivity to pirlimycin, or to treat organisms known to be resistant to pirlimycin. Cross-resistance may occur between pirlimycin and other lincosamides or macrolides. Do not use for the treatment of infections due to Gram-negative bacteria such as E. coli. Susceptibility testing of the target bacteria should be carried out prior to treatment.

Do not treat cows with palpable udder changes due to chronic subclinical mastitis.

Withdrawal Period

Animals must not be slaughtered, or milk be taken, for human consumption during treatment.

Meat and offal: 23 days.

Milk: 5 days. (i.e. safe at the 11th milking for cows milked twice daily)

Operator Warnings

Avoid contact with the solution. Wash hands and any exposed skin with soap and water and remove contaminated clothing immediately after use. If solution enters the eye flush eyes with water for 15 minutes immediately after exposure. Hold eyelids open to ensure complete contact with water. For animal treatment only. Keep out of reach of children.

Pharmaceutical precautions

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.