Pirsue (pirlimycin) – Summary of product characteristics - QJ51FF90
Updated on site: 09-Feb-2018
|Proizvođač:||Zoetis Belgium SA|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period(s)
- 5. PHARMACOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
Pirsue 5 mg/ml intramammary solution for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe
For the full list of excipients see Section 6.1
Cattle (lactating dairy cows)
4.2Indications for use, specifying the target species
For the treatment of subclinical mastitis in lactating cows due to
Resistance against pirlimycin.
Treatment of infections due to
Do not treat cows with palpable udder changes due to chronic subclinical mastitis.
4.4Special warnings for each target species
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)
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
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.
Pharmacotherapeutic group: Antibacterial for intramammary use.
ATCvet code: QJ51FF90
Pirlimycin hydrochloride is a
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.
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,
6.1List of excipients
Anhydrous citric acid
Water for injection
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
8.MARKETING AUTHORISATION NUMBER(S)
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