Pirsue
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-06-2021
Charakterystyka produktu
(SPC)
18-06-2021
Sprawozdanie z oceny publicznego
(PAR)
03-06-2013
Składnik aktywny:
pirlimycin
Dostępny od:
Zoetis Belgium SA
Kod ATC:
QJ51FF90
INN (International Nazwa):
pirlimycin
Grupa terapeutyczna:
Cattle
Dziedzina terapeutyczna:
Antibacterials for intramammary use
Wskazania:
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.
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Authorised
Data autoryzacji:
2001-01-29
Ulotka dla pacjenta
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
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Charakterystyka produktu
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
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