Pirsue: Product Information

PIRSUE- pirlimycin hydrochloride injection, solution
Zoetis Inc.

For Intramammary Infusion in Lactating Cows Only

FOR USE IN ANIMALS ONLY — NOT FOR HUMAN USE

CAUTION

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

Pirlimycin hydrochloride is a lincosaminide antibiotic.

Chemical Structure of Pirlimycin Hydrochloride
Chemical Structure
(click image for full-size original)
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 monohydrochloride hydrate.

PIRSUE Sterile Solution is a clear solution.

Each 10 mL PLASTET® Disposable Syringe contains:
Pirlimycin free base equivalents (as the hydrochloride salt) 50 mg
Anhydrous citric acid42.3 mg
Sodium citrate88.2 mg

Water for injection

q.s.

INDICATIONS FOR USE

PIRSUE Sterile Solution (pirlimycin hydrochloride intramammary infusion) 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.

DOSAGE

Infuse one (1) syringe into each affected quarter. Use proper teat end preparation and sanitation and proper intramammary infusion technique (see ADMINISTRATION). Repeat treatment after 24 hours. Daily treatment may be repeated at 24-hour intervals for up to 8 consecutive days.

ADMINISTRATION

Teat End Preparation

Wash teats thoroughly with water containing a suitable dairy antiseptic. Dry the teats thoroughly. Milk out the udder completely. Using the alcohol pad provided, wipe the teat end of the affected quarters, using a separate pad for each teat. Allow sufficient time (at least 5 to 10 seconds) for the alcohol to dry. Use of protective gloves by persons applying treatment is recommended as part of aseptic infusion technique.

Important Considerations for Extended Therapy

For extended duration of therapy, infuse only quarters known to be infected with label pathogens. Do not concurrently infuse uninfected low SCC quarters of the same cow. Prepare the teats using the above instructions, and then infuse PIRSUE Sterile Solution using aseptic infusion technique and partial insertion (see diagram below).

Infusion

The Plastet disposable syringe is designed to provide the choice of either insertion of the full cannula as has traditionally been practiced, or insertion of no more than 1/8 inch of the cannula, as reported by Eberhart, R.J., et. al., 1987. Current Concepts of Bovine Mastitis, 3rd Edition, National Mastitis Council, Arlington, VA.

a. Full insertion: Remove the white end cap by pulling straight up as shown. Gently insert the full cannula into the teat canal.

b. Partial insertion: Remove the white end cap by pulling straight up as shown. Gently insert the exposed white tip into the teat canal.

Diagram

Choose the desired insertion length (full or partial) and gently insert the tip into the teat canal. Carefully push the plunger to infuse the entire contents, and then massage the quarter to distribute the solution into the milk cistern. Following infusion, dip all quarters with an antiseptic teat dip. Cows with systemic clinical signs caused by mastitis should receive other appropriate therapy under the direction of a licensed veterinarian.

.

Reinfection

After treatment, reinfection may occur unless good herd management, sanitation, and mechanical safety measures are practiced. Affected cows should be watched carefully to detect recurrence and possible spread of infection to other animals

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

RESIDUE WARNINGS

  1. Milk taken from animals during treatment and for 36 hours after the last treatment must not be used for food regardless of treatment duration.
  2. Following infusion twice at a 24-hour interval, treated animals must not be slaughtered for 9 days.
  3. Following any extended duration of therapy (infusion longer than twice at a 24-hour interval, up to 8 consecutive days), animals must not be slaughtered for 21 days.
  4. Use of this product in a manner other than indicated under DOSAGE might result in violative residues.

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.

ADVERSE REACTIONS

As demonstrated in the pivotal target animal safety study, even with adequate pre-treatment preparation, repeated infusion of PIRSUE Sterile Solution resulted in elevated SCC and clinical mastitis due to infection with Gram-negative environmental pathogens. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae. For technical assistance, to report suspected adverse reactions, or to request a Safety Data Sheet (SDS), call 1-888-963-8471.

MICROBIOLOGY

Pirlimycin is a lincosaminide antibiotic that has activity against Gram-positive mastitis pathogens. Pirlimycin functions by binding to the 50S ribosomal subunit of bacterial ribonucleic acid, which interferes with protein synthesis within the bacteria. In vitro activity of pirlimycin has been demonstrated against Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis , four pathogens associated with clinical and subclinical mastitis in lactating dairy cattle.

Utilizing data that included isolates from cows with mastitis, zone diameter interpretive criteria and minimum inhibitory concentration (MIC) breakpoints were determined using standardized procedures from the Clinical and Laboratory Standards Institute (CLSI, formerly National Committee of Clinical Laboratory Standards) M31-A2. The CLSI-accepted interpretive criteria for pirlimycin against Gram-positive mastitis pathogens are shown in Table 1

Table 1. CLSI-Accepted Interpretive Criteria for Pirlimycin Against Bovine Mastitis Pathogens*

Pathogen

Disk Potency

Zone Diameter Interpretive Standards (mm)

MIC Breakpoint (µg/mL)

S

R

S

R

Staphylococcus aureus

Streptococcus agalactiae

Streptococcus dysgalactiae

2 µg

13

12

2.0

4.0

Streptococcus uberis

S — Susceptible
R — Resistant

* These interpretive criteria are only intended for use when CLSI M31-A2 performance standards are used to determine antimicrobial susceptibility.

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