Inforce 3

ZOETIS INC.
333 PORTAGE STREET, KALAMAZOO, MI, 49007
Telephone: 269-359-4414
Customer Service: 888-963-8471
Website: www.zoetis.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.
INFORCE 3®

Zoetis

Bovine Rhinotracheitis-Parainfluenza3-Respiratory Syncytial Virus Vaccine

Modified Live Virus

For intranasal use only

INDICATIONS: For vaccination of healthy cattle 3 days of age or older, including pregnant cows, to prevent respiratory disease caused by bovine respiratory syncytial virus (BRSV), and as an aid in preventing respiratory disease caused by infectious bovine rhinotracheitis (IBR) virus and parainfluenza3 (PI3) virus. A duration of immunity of at least 193 days has been demonstrated against IBR; duration of immunity against BRSV and PI3 has not been established.

DESCRIPTION: INFORCE 3 is a freeze-dried preparation of temperature-sensitive strains of IBR and PI3 viruses and modified live BRSV, packaged with a sterile diluent for rehydration.

SAFETY AND EFFICACY:

In a safety study conducted with INFORCE 3, no significant adverse reactions related to vaccination were observed. Safety has been demonstrated in calves as young as 0 days of age, weaned calves, high-stressed stockers, and pregnant cows in all 3 trimesters.

Efficacy of the BRSV fraction of INFORCE 3 was demonstrated in two vaccination-challenge studies. Calves were administered either a single 2-mL dose in one nostril or 1-mL doses in each nostril. One hundred percent of calves as young as 3 days of age, vaccinated with a 2-mL dose administered in a single nostril and challenged 49 and 57 days later survived virulent challenge. In both studies, INFORCE 3 vaccinates experienced significantly lower mortality, significantly less lung damage and significantly less viral shedding for a significantly shorter duration than control cattle.

Efficacy of the PI3 fraction was also demonstrated in two vaccination-challenge studies, conducted as described above. In both studies, calves vaccinated with INFORCE 3 were protected against a virulent PI3 challenge, as evidenced by shortened durations of virus shedding, when compared with non-vaccinated control calves.

Short- and long-term efficacy of the IBR fraction were demonstrated in two studies. In the first study, weaned, 7- to 9-month-old vaccinated calves demonstrated 95% less incidence and a 95.6% reduction in disease duration compared to controls when challenged 28 days after vaccination.

Researchers also saw favorable impacts on rectal temperatures and nasal shedding of virus. In the second study, calves as young as 3 days of age were vaccinated with a single 2-mL dose and challenged more than 6 months (193 days) later. Vaccinates were observed to have 75.6% less incidence of IBR and a 63.8% reduction in duration of disease compared to controls. Favorable impacts on temperature, nasal shedding, and antibody titers were also seen.

DIRECTIONS:

General Directions: Aseptically rehydrate the freeze-dried vaccine with the sterile diluent provided, shake well, and administer 2 mL intranasally (IN) using a cannula or a syringe with the needle removed.

Primary Vaccination: Place the 2-mL dose in one nostril, or half the dose (1 mL) in each nostril. The presence of maternal antibody is known to interfere with the development of active immunity in cattle, and additional boosters will be required in most young animals.

For advice on revaccination frequency, consult your veterinarian or the manufacturer.

PRECAUTIONS:

Store at 2°-8°C. Prolonged exposure to higher temperatures and/or direct sunlight may adversely affect potency. Do not freeze.

Use entire contents when first opened.

Sterilized syringes should be used to administer this vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine.

Inactivate unused contents before disposal.

Do not vaccinate within 21 days before slaughter.

Contains gentamicin as preservative.

Fetal health risks associated with the vaccination of pregnant animals with modified live vaccines cannot be unequivocally determined during clinical trials conducted for licensure. Appropriate strategies to address the risks associated with modified live vaccine use in pregnant animals should be discussed with a veterinarian.

As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.

Do not mix with other products, except as specified above.

In case of human exposure, contact a physician.

This product has been shown to be efficacious in healthy animals. A protective immune response may not be elicited if animals are incubating an infectious disease, are malnourished or parasitized, are stressed due to shipment or environmental conditions, are otherwise immunocompromised, or the vaccine is not administered in accordance with label directions.

Technical inquiries should be directed to Zoetis Inc. Veterinary Services, (888) 963-8471.

For veterinary use only

VLN 190/PCN 1071.23

Zoetis Inc., Kalamazoo, MI 49007, USA

50353800

1-dose vial of vaccine, rehydrate to 2 mL

2-mL vial of sterile diluent



10-dose vial of vaccine, rehydrate to 20 mL

20-mL vial of sterile diluent



25-dose vial of vaccine, rehydrate to 50 mL

50-mL vial of sterile diluent



50-dose vial of vaccine, rehydrate to 100 mL

100-mL vial of sterile diluent

5266000

11248800

CPN: 3690261.3



COLORADO SERUM COMPANY4950 YORK STREET, P.O. BOX 16428, DENVER, CO, 80216-0428Telephone: 303-295-7527Order Desk: 800-525-2065Fax: 303-295-1923Website: www.colorado-serum.comEmail: colorado-serum@colorado-serum.comTHIS 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.

TETANUS TOXOID-CONCENTRATED

Colorado Serum

Adjuvanted

GENERAL INFORMATION: This product has been shown to be effective for the vaccination of healthy horses, cattle, sheep, goats, and swine against tetanus. This product was licensed prior to the requirement to establish a minimum age for use. The duration of immunity is unknown. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Safety in pregnant animals is unknown.

Tetanus Toxoid is prepared by detoxifying tetanus toxin in such a manner as to allow the antigenic properties to remain intact. Product is purified, concentrated and adjuvanted to provide a low dose effective immunizing agent.

Each serial is tested for purity, safety, and potency in accordance with USDA requirements.

Tetanus is caused by a neurotoxin produced by growth of Clostridium tetani, an anaerobic (lives without air) micro-organism, in necrotic tissue. Affected animals become stiff, have difficulty swallowing, and have an increased pulse rate. Breathing is labored. Spasmodic contractions of the muscular system occur, such as contracting muscles of the jaw.

Spasmodic contractions of the muscular system occur, such as contracting muscles of the jaw. Thus, the term “lockjaw” is often used. Legs and tail are often stiff with abdominal muscles contracted. Tetanus stricken animals may be unusually sensitive to light and heat. Temperature of the animal generally remains normal, elevating only shortly before death.

Protective antibody levels usually occur about two weeks after the second injection of the primary immunization series. In contrast, administration of Tetanus Antitoxin is recommended for immediate, emergency, passive treatment of exposed animals with unknown vaccination history or with signs of tetanus infection.

DIRECTIONS: Do not vaccinate within 21 days before slaughter. Store at 2-8° C. Do not freeze. Do not mix with other products. Shake well before use. Use entire contents when first opened.

PRECAUTIONS: A transitory local reaction may occur at injection site. Anaphylactoid reaction may occur following administration of products of this nature. If noted, administer adrenalin or equivalent. In case of human exposure, consult a physician.

DOSAGE & ADMINISTRATION: For primary immunization, two doses should be administered subcutaneously or intramuscularly approximately 30 days apart. Use intramuscularly for horses as local reactions are more likely to occur if injected subcutaneously.

Horses: 1 ml IM

Cattle: 1 ml SC or IM

Sheep, Goats, Swine: 0.5 ml SC or IM

Historically, annual single dose revaccination has been recommended. Contact veterinarian for advice.

OTHER INFORMATION: Contains thimerosal and formalin as preservatives. Tetanus Toxoid Concentrate is available in single dose size packaged 10 vials to the carton, and in 10 dose vials.

THE PEAK OF QUALITY SINCE 1923

VLN: 188 / PCN: 8601.00

COLORADO SERUM COMPANY, 4950 York Street, Denver, Colorado 80216

303-295-752

www.colorado-serum.com

Contact us for information on other Colorado Serum Company products. Fine Veterinary Products since 1923.

FOR VETERINARY USE ONLY

Order #

10 - 1 ml vials

10 - 1 dose vials

11411

10 ml

10 doses

11415

CPN: 1101033.3