Pirlimycin hydrochloride is a lincosaminide antibiotic.
Chemical Name of Pirlimycin Hydrochloride
Methyl(2S-Cis)-7-chloro-6,7,8-trideoxy-6[[(4-ethyl-2-piperidinyl)carbonyl]amino]-1-thio-L-threo-α-D-galacto-octo-pyranoside hydrochloride hydrate.
PIRSUE Sterile Solution is a clear solution.
Each 10 mL PLASTET® Disposable Syringe contains:
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Pirlimycin free base equivalents
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50 mg
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Aqueous vehicle
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q.s.
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INDICATIONS FOR USE
PIRSUE Sterile Solution (pirlimycin hydrochloride) is indicated for the treatment of clinical and subclinical mastitis in lactating dairy cattle associated with Staphylococcus species such as Staphylococcus aureus and Streptococcus species such as Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis.
WARNING
Repeated infusion during extended duration therapy regimens, even with adequate teat end preparation and sanitation, can result in elevated somatic cell counts and/or clinical mastitis, which can result in animal death. If acute clinical mastitis or other clinical signs of illness develop during extended duration therapy with PIRSUE, discontinue therapy immediately and contact your veterinarian.
Discard Empty Container; DO NOT REUSE
KEEP OUT OF REACH OF CHILDREN
PRECAUTION
When using extended duration therapy with PIRSUE Sterile Solution, failure to thoroughly clean quarters and to use aseptic infusion technique can result in the infusion of environmental mastitis pathogens not sensitive to pirlimycin.
MILK AND TISSUE RESIDUE DEPLETION
The established tolerance of pirlimycin in milk is 0.40 ppm. Milk residue depletion studies were conducted in cows with clinical mastitis. In one study, cows were infused with 50 mg of pirlimycin twice at a 24-hour interval into all quarters regardless of the number of affected quarters. In a second study, cows with a single mastitic quarter were infused with 50 mg of pirlimycin twice at a 24-hour interval into only the affected quarter. In a third study, normal cows were infused with 50 mg of pirlimycin twice at a 24-hour interval into all four quarters. As a result of these three studies, milk taken from cows during treatment and for 36 hours following treatment must not be used for food and must be discarded. For extended duration of therapy (once daily for up to 8 consecutive days), a milk residue study was conducted where cows received 50 mg of pirlimycin per quarter into all four quarters for 8 consecutive days. This study confirmed that milk taken from cows during treatment and for 36 hours following the last treatment must not be used for food and must be discarded.
EFFECT ON MILK MANUFACTURING STARTER CULTURES
A study was conducted to examine the effect of varying concentrations of pirlimycin in milk on the growth of bacterial starter cultures used to produce fermented milk products. Pirlimycin did not adversely affect bacterial starter cultures used for the production of fermented milk products at concentrations found following normal label use including proper milk discard periods. Violative levels of pirlimycin (>0.40 ppm) can adversely affect the growth of bacterial starter cultures.
STORAGE CONDITIONS
Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).
Store Plastets in Carton or Pail Until Used.
HOW SUPPLIED
PIRSUE Sterile Solution is available in unbroken packages of 12-10 mL Plastet Disposable Syringes with 12 individually wrapped 70% isopropyl alcohol pads. The Plastet Disposable Syringes are packaged in Cartons (12-10 mL Plastet Disposable Syringes per carton) and in Pails (12 packages of 12-10 mL Plastet Disposable Syringes or 144 Plastets per pail).
