Canine Parvovirus Monoclonal Antibody

This treatment applies to the following species:

Dogs

Company: Elanco US

For Use in Dogs Only

For use by, or under the supervision of, a veterinarian

The product has shown a reasonable expectation of efficacy against mortality for the treatment of canine parvovirus (CPV) in dogs 8 weeks of age or older when administered at 4 days post exposure to CPV-2b to dogs without a prior history of vaccination for CPV. This product license is conditional; efficacy and potency have not been fully demonstrated. Safety has been demonstrated in healthy dogs. For more complete information regarding safety, go to productdata.aphis.usda.gov.

CPV causes enteritis in dogs where the incidence of severe illness and death can be very high in susceptible dogs. The disease is most common in puppies as their maternally derived antibodies wane and in older unvaccinated puppies. The product, Canine Parvovirus Monoclonal Antibody, selectively binds and neutralizes canine parvovirus.

Composition

This product is a sterile liquid containing a chimeric monoclonal antibody (rat variable region, canine constant region) against canine parvovirus (CPV) viral protein 2.

Directions For Use

The product is supplied and stored frozen at ≤-15°C (≤5°F) and is ready to use once thawed. Thaw at room temperature (~17-25°C) and immediately administer intravenously at a dose of 0.2 ml/kg (0.2 ml/2.2 lb) of the dog’s body weight.

Examples of the volume to administer are provided in the table below. If more than one vial is required due to the weight of the dog, draw from each vial into one syringe and administer as a single injection. Vials are single-use, and any remaining product is to be discarded.

Dog’s body weight POUNDS	Dog’s body weight KILOGRAMS	Volume to administer
2.2	1	0.2 ml
11	5	1 ml
22	10	2 ml
33	15	3 ml
44	20	4 ml
55	25	5 ml

Efficacy:

Twenty-eight CPV negative purpose bred dogs were intranasally challenged with virulent canine parvovirus type 2b (CPV-2b) at 8 weeks-of-age. All dogs tested positive for CPV in feces (by SNAP test) four days after challenge, with or without clinical signs of canine parvovirus. The same day as testing positive by SNAP test, the dogs were treated intravenously with a single dose (0.2 ml/kg) of the CPV monoclonal product or placebo. Virulent CPV-2b challenge resulted in no mortality of the CPV monoclonal treated dogs (0/21; 0% mortality) compared to the placebo control group (4/7; 57% mortality) during the 14 day observation period.

Safety:

Field safety data analysis of 147 client owned dogs of various breeds, ranging from 6 weeks of age to 15 years and weighing between 0.6 - 59.2 kg (1.3 - 130 lbs), and located in nine separate sites concluded the product is well tolerated when administered to healthy dogs by the intravenous route. No anaphylactic reactions or clinical presentations consistent with anaphylaxis were reported.

Adverse Reactions

The following tables present adverse reactions that were reasonably associated with the use of this product in the clinical field safety trial. Most were mild and recovered within one day. Three dogs took 2-4 days to recover. One dog had continuing site inflammation until study exit (14 days after injection). For more complete information regarding safety and adverse events, see productdata.aphis.usda.gov. The most common adverse reactions reported were injection site reactions (4%).

Table 1. Injection Site Reactions

Injection Site Reaction VeDDRA Code	No. of Dogs Exhibiting Reaction (n=147)
Erythema	3 (2%)
Inflammation	2 (1%)
Edema	1 (<1%)
Pain	2 (1%)
Total No. of Dogs Affected*	6 (4%)

*Some dogs displayed multiple injection site reactions when affected.

Table 2. Systemic Adverse Reactions

Adverse Reaction VeDDRA Code	No. of Dogs Exhibiting Reaction (n=147)
Diarrhea	2 (1%)
Pruritis	1 (<1%)
Total No. of Dogs Affected*	3 (2%)

Precautions

STORE FROZEN at ≤ -15°C (≤5°F). Single Use. For IV administration only. For use by, or under the supervision of, a veterinarian. Use entire contents after thawed and when first opened, do not refreeze. Do not mix with other products. In case of anaphylactoid reaction, administer epinephrine. This product has not been tested in pregnant animals.

Warnings

In case of human exposure, contact a physician. Along with active immunity initiated by the naturally occurring CPV infection, the use of this monoclonal antibody as therapeutic treatment may interfere with subsequent CPV vaccination. For advice on CPV vaccination scheduling after use, consult your veterinarian.

Elanco US Inc., Elwood, KS 66024

Phone: 888-545-5973

VLN/PCN 196/3415.20

Canine Parvovirus Monoclonal Antibody Caution

In the absence of a veterinarian-client-patient relationship, Federal law prohibits the relabeling, repacking, resale, or redistribution of the individual contents of this package.

Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

PA103743A

W2a

Presentation: 1 mL and 2 mL vials.

CPN: 2133000.0

ELANCO US, INC.
Distributed by ELANCO US, INC.
2500 INNOVATION WAY, GREENFIELD, IN, 46140

Customer Service:		317-276-1262
Technical Service:		800-428-4441
Website:		www.elanco.us
Email:		elanco@elanco.com

THIS SERVICE AND DATA ARE PROVIDED "AS IS". DVMetrics assumes no liability, and each user assumes full risk, responsibility, and liability, related to its use of the DVMetrics service and data. See the Terms of Use for further details.