Imrestor (10-Dose)

Imrestor is FDA approved for the reduction in the incidence of clinical mastitis in the first 30 days of lactation in dairy cows and replacement dairy heifers. Imrestor is a protein that helps support the natural function of a dairy cow's immune system during the critical time around calving, when she is most vulnerable to mastitis.

Key Benefits

• Imrestor helps restore the integrity of a cow's innate immune system during the time when she experiences immune suppression
• Imrestor is approved by Health Canada for the reduction in the incidence of clinical mastitis in the first 30 days of lactation in periparturient dairy cows, and replacement dairy heifers
• Imrestor requires a veterinarian's prescription
• Imrestor is a non-antibiotic preventative health solution
• Imrestor is not an antibiotic, vaccine, or hormone
• Imrestor, the first, and only immune-modulator for periparturient dairy cows and heifers
• Restore the function of a cow's innate immune system when immune suppression leaves her vulnerable to infection
• Reduce the incidence of clinical mastitis around calving
• Protect her potential, and the well-being of the entire dairy, as well as minimize the frustration of treating mastitis, with a product that is proven safe, and effective for your herd.

Indications

For the reduction in the incidence of clinical mastitis in the first 30 days of lactation in dairy cows and replacement dairy heifers.

Active Ingredient:

15 mg pegbovigrastim per 2.7 mL single-dose syringe

View Imrestor Drug Facts Sheet.

This is a two-dose regimen. The same dose is used regardless of cow/heifer body weight. Remove surface dirt from the injection site area before injecting. Inject the entire contents of the syringe subcutaneously. Do not reuse the syringe.

Administer the first dose (syringe) 7 days prior to the cow's or heifer's anticipated calving date. If necessary, the first dose may be administered within a range of 4 to 10 days prior to the anticipated calving date to accommodate management schedules. Administer the second dose (syringe) within 24 hours after calving.

Animals that calve less than 7 days after the first dose should still receive the second dose within 24 hours after calving. Animals that calve more than 7 days after the first dose should also receive the second dose within 24 hours after calving.

Prior to administration, Imrestor should be visually inspected for particulate matter and discolouration. Imrestor is a clear, colourless solution and may contain a few small, translucent or white particles. Imrestor should not be used if it is discoloured or cloudy, or if other particulate matter is present. Do not shake or tap the syringe prior to use.

Caution:

Imrestor is not for use in the treatment of cases of clinical mastitis. Treatment of clinical mastitis should be done in consultation with a veterinarian.

Do not use Imrestor contrary to the indications for use.

Results from the first Margin of Safety study indicated that exceeding the recommended dosage may have been associated with:

• Increased risk of splenomegaly (enlargement of the spleen)
• Increased somatic cell counts in milk
• Increased incidence of abomasal or duodenal ulcers

Warnings:

Withdrawal Periods:

No withdrawal period or milk withholding time is required when used according to the label directions.

Not for use in humans. Keep out of reach of children.

User Safety Warnings:

In case of accidental self-injection, wash the site of injection thoroughly with clean running water. Foreign proteins such as pegbovigrastim have the potential to cause anaphylactic-type reactions. If you experience swelling or redness at the site of exposure, or more severe reactions such as shortness of breath, seek medical attention immediately and take the package insert with you. Report the event to Elanco at 1-800-265-5475.

Adverse Reactions:

Hypersensitivity-type reactions have been reported rarely (more than 1 but less than 10 animals in 10,000) within five minutes to two hours, occurring most often after the first administration of Imrestor. Clinical signs may include elevated respiratory rate, dyspnea, urticaria, sweating, dependent edema, swollen mucous membranes, and/or hypersalivation. These reactions resolve within hours of onset with or without therapeutic intervention and have not been shown to reoccur with subsequent injections of Imrestor. Very rarely, clinical signs may also include death (less than 1 animal in 10,000 animals). To report suspected adverse drug events, contact Elanco at 1-800-265-5475.

Storage:

Store under refrigeration (2° to 8°C). DO NOT FREEZE. Avoid prolonged exposure to sunlight. Excursions of up to 24 hours at room temperature (15° to 30°C) are allowed after receipt.

Environmental Safety:

Dispose of used syringes in a leak-resistant, puncture-resistant container in accordance with applicable federal, provincial and local regulations.