Recombitek 4 Lepto (Canada)

Company: Merial

Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterin

LCGIP

Description

Recombitek^® 4 Lepto is a liquid suspension of Leptospira bacterins containing serovars canicola, grippotyphosa, icterohaemorrhagiae and pomona (LCGIP). Safety and immunogenicity of this product have been demonstrated by vaccination and challenge studies

in susceptible dogs.

Recombitek 4 Lepto Indications

This product is recommended for vaccination of healthy dogs 9 weeks of age and older for the prevention of leptospirosis and leptospiruria caused by Leptospira canicola, L. grippotyphosa and L. icterohaemorrhagiae, and as an aid in the prevention of leptospirosis and leptospiruria caused by L. pomona.

Leptospira grippotyphosa Duration of Immunity Results Summary¹

Twenty-two 9-week-old specific-pathogen-free puppies were vaccinated subcutaneously, twice, 21-days apart, with a 1 mL dose of the efficacy vaccine. Four hundred seventy days after the second vaccination (15.5 months) twenty vaccinated dogs and twenty two control dogs (vaccinated with a placebo) were administered by intraperitoneal and conjunctival routes, a dog virulent Leptospira grippotyphosa challenge (RM52 isolate). Blood and urine samples were collected prior to and after challenge for Leptospira isolation. Blood was also collected prior to and after vaccination and prior to and after challenge for complete blood counts, serum chemistry, and to measure serovar specific antibody titers for all four Leptospira serovars. Thirty-four days following challenge renal tissue was collected and scored 0 (Normal) to 3 (Severe) based on severity of histopathology. Observations for clinical signs were also made prior to and following challenge. All puppies were serologically negative (at 1:100 by Mean Agglutination Titer) to Leptospira grippotyphosa, L. canicola, L. icterohaemorrhagiae and L. pomona serovars at the initiation of the study.

A dog was classified as having leptospirosis if it had one or more urine samples positive for spirochetes and renal pathology or had multiple urine samples positive for spirochetes in the absence of renal pathology. Leptospiruria was defined as shedding Leptospira organisms in the urine on any day sampled after challenge.

Following a virulent challenge 470 days (15.5 months) after the second vaccination 100% (20/20) of vaccinates were protected from leptospirosis despite most vaccinates being commingled with control dogs actively shedding spirochetes in their urine. Sixteen of 21 (76.2%) dogs vaccinated with the placebo vaccine developed leptospirosis. The prevented fraction for leptospirosis 15.5 months after vaccination was 100% with a corresponding 95% confidence interval of 80.3% to 100%. The incidence of Leptospirosis is summarized in Table 1.

Table 1: Incidence of Leptospirosis

*One dog did not complete the study

**Two dogs did not complete the study

The prevented fraction for leptospiruria among vaccinates commingled with controls was 93% with a 95% exact confidence interval of 68.6%-99.8%. The incidence of leptospiruria is summarized in Table 2.

Table 2: Incidence of Leptospiruria

The results of this study demonstrate the vaccine is able to prevent leptospirosis and leptospiruria due to Leptospira grippotyphosa for at least 470 days (15.5 months) following vaccination of 9-week-old puppies with a 1 mL dose, subcutaneously, twice, twenty one days apart.

DOSAGE: Aseptically inject 1 mL (1 dose) subcutaneously into healthy dogs. For primary vaccination, revaccinate with a second 1 mL dose 3 to 4 weeks later. Revaccination annually with a single 1 mL dose is recommended, although, the revaccination frequency should be determined by the attending veterinarian based on the animal’s age, breed, health status, environment, lifestyle and travel habits.² Duration of immunity for L. grippotyphosa was demonstrated by challenge in dogs to be at least 15 months following vaccination.

Precautions

Store at 2-7°C (35-45°F). Do not freeze. Do not use chemicals to sterilize syringes and needles. This product has not been evaluated in pregnant dogs. In rare instances, administration of vaccines may cause lethargy, fever, and inflammatory or hypersensitivity types of reactions. Treatment may include antihistamines, anti-inflammatories, and/or epinephrine, as directed by a veterinarian.

SOLD TO VETERINARIANS ONLY. For use in dogs only.

¹Data on file with USDA and CFIA

²2006 American Animal Hospital Association (AAHA) Canine Vaccine Guidelines, Revised

For Veterinary Use Only.

Manufactured By MERIAL, INC., Athens, GA 30601 USA, U.S. Vet. Lic. No. 298

1-888-Merial-1 (1-888-637-4251)

Distributed in Canada by: MERIAL CANADA INC., Baie d’Urfé, QC H9X 4B6

^®RECOMBITEK is a registered trademark of Merial.

©2011 Merial. All rights reserved.

RM2063R2

CPN: 11821421