Pirsue (pirlimycin) – Summary of product characteristics - QJ51FF90

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Pirsue 5 mg/ml intramammary solution for cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe

For the full list of excipients see Section 6.1

3.PHARMACEUTICAL FORM

Intramammary solution

4.CLINICAL PARTICULARS

4.1Target species

Cattle (lactating dairy cows)

4.2Indications 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.

4.3Contraindications

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.

4.4Special warnings for each target species

None.

4.5Special 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.

4.6Adverse reactions (frequency and seriousness)

None known

4.7Use during pregnancy, lactation or lay

The product is indicated for use in lactating dairy cows and can be used during pregnancy.

4.8Interaction with other medicinal products and other forms of interaction

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

4.9Amounts to be administered and administration route

Administration: by intramammary infusion only.

Infuse one syringe (50 mg pirlimycin) into each infected quarter.

Treatment consists of eight infusions of one syringe every 24 hours.

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 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No data on overdosing are available.

4.11 Withdrawal period(s)

Meat and offal: 23 days.

Milk: 5 days.

5.PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterial for intramammary use.

ATCvet code: QJ51FF90

5.1Pharmacodynamic properties

Pirlimycin hydrochloride is a semi-synthetic lincosamide antibiotic. The lincosamides (clindamycin, lincomycin, and pirlimycin) inhibit protein synthesis in Gram-positive and in anaerobic bacteria as well as in Mycoplasma spp. They work by binding to the 50S ribosomal subunit, therefore hindering the aminoacyl-tRNA binding and inhibiting the peptidyltransferase reaction, which interferes with protein synthesis within the bacteria.

Gram-positive isolates with an MIC > 2 µg/ml are to be considered resistant. Enteric bacteria such as E. coli are intrinsically resistant to pirlimycin.

Pirlimycin has a basic pKa (8.5). This means it will be more active in an acid environment and tends to concentrate, relative to plasma, in areas with lower pH, such as abscesses. Pirlimycin has been shown to accumulate in polymorphonuclear cells, however, intracellular killing of

Staphylococcus aureus was not demonstrated.

5.2Pharmacokinetic particulars

After intramammary infusion, mean parent concentrations in milk were 10.3 µg/ml at 12 hours and 0.77 µg/ml at 24 hours. Similar concentrations were reached at 12 and 24 hours after a second infusion at a 24 hour interval. Of the dose infused, 10-13% is excreted in the urine, and 24-30% via the faeces; the remainder is excreted in the milk.

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Anhydrous citric acid

Sodium citrate

Water for injection

6.2Incompatibilities

None known.

6.3Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

6.4. Special precautions for storage

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

6.5Nature and composition of immediate packaging

Sterile aqueous solution in 10 ml polyethylene intramammary syringes, packaged as 8 x 10 ml, 24 x 10 ml in an outer cardboard box. Also packaged as 120 x 10 ml syringes in a plastic bucket.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7.MARKETING AUTHORISATION HOLDER

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

8.MARKETING AUTHORISATION NUMBER(S)

EU/2/00/027/001-003

9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 29/01/2001

Date of last renewal: 08/02/2006

10 DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

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