PERMAWAY 600 mg intramammary suspension for cattle

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Cloxacillin Benzathine

Tilgjengelig fra:

Vetoquinol Ireland Limited

ATC-kode:

QJ51CF02

INN (International Name):

Cloxacillin Benzathine

Dosering :

600 milligram(s)

Legemiddelform:

Intramammary suspension

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

cloxacillin

Autorisasjon status:

Authorised

Autorisasjon dato:

2021-04-23

Preparatomtale

Health Products Regulatory Authority
23 April 2021
CRN009FKH
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PERMAWAY 600 mg intramammary suspension for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each intramammary syringe (3.6 g) contains:
ACTIVE SUBSTANCE:
Cloxacillin (as benzathine) 600 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary suspension.
Shiny white to off-white viscous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dairy cattle (dry cows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of subclinical mastitis at dry-off and prevention of
new intramammary infections occurring during the dry
period, caused by _Trueperella pyogenes, Staphylococcus spp.,
Streptococcus agalatiae, Streptococcus dysgalactiae _and_ _
_Streptococcus uberis_, susceptible to cloxacillin.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to penicillins,
cephalosporins, or to any of the excipients. Do not use in cows with
clinical mastitis outside the dry period.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
This product does not contain any antimicrobial preservatives.
Special precautions for use in animals
Use of the product should be based on susceptibility testing of
bacteria isolated from milk samples obtained from the udder
quarter(s) of each cow to be dried off. If this is not possible,
therapy should be based on local (regional, farm level) risk based
epidemiological information about the expected pathogen challenge, and
susceptibility of target bacteria.
Use of the product deviating from the instructions given in the SPC
may contribute to the development of bacterial resistance
to cloxacillin which may also decrease the effectiveness of treatment
with other beta-lactamase resistant penicillins. Dry cow
therapy protocols should take local and national policies on
antimicrobial use into consideration, and undergo regular
veterinary review.