OK OK OK 1 L. Nelson L. GA
CHANGES CHANGES CHANGES
G. Woods G.
GS
Rev GS / ART REV (FA) REV ART / GS (LCA) REV ART / GS PR GA
to Z35-802061; Z35-802063 Z35-802061; to
Black Dieline DATE: GS:
*Sub-Assembly Artwork attached attached Artwork *Sub-Assembly
EDITOR’S COPY EDITOR’S
Colors: Info: Additional
Z63/Insert 10009927 10009907, Z14-801566 folded) 1.5” x (1.5” 9” x 9”
Dimensions DIR Type/Description DIR No. Material FG No. Drawing
Z35-802063/Comp. Mat# 40017413 Mat# Z35-802063/Comp. 50415000 14600 US 8 Ultra Shot One
Z35-802061/Comp. Mat# 40017414; 40017414; Mat# Z35-802061/Comp.
Artwork DIR No. DIR Artwork No. Project Country Description No. Material Component
3/15/17 1:07 PM 1:07 3/15/17 50415000.indd 1 50415000.indd Time/Date:
50415000
(SC) under the skin. the under (SC) Code
lines, this product should be administered subcutaneously subcutaneously administered be should product this lines, guide Assurance I2 of 5 5 of I2
administer 2 mL subcutaneously. In accordance with Beef Quality Quality Beef with accordance In subcutaneously. mL 2 administer
8), shake well, and and well, shake 8), with the accompanying vial of diluent (UltraChoice diluent of vial accompanying the with
®
Aseptically rehydrate the freeze-dried bacterin-toxoid (One Shot Ultra 8) 8) Ultra Shot (One bacterin-toxoid freeze-dried the rehydrate Aseptically
GLUE PANEL GLUE
General Directions: General 1. Vaccination of healthy cattle is recommended. is cattle healthy of Vaccination
DIRECTIONS:
serologic studies. serologic
a placebo. Immuno placebo. a genicity of the clostridial fractions was confirmed by by confirmed was fractions clostridial the of genicity
significant reduction (82.6%) in lung damage compared to animals receiving receiving animals to compared damage lung in (82.6%) reduction significant
M. haemolytica type A1 infection. Vaccinates demonstrated a statistically statistically a demonstrated Vaccinates infection. A1 type
were evaluated for lung damage and lesions characteristic of of characteristic lesions and damage lung for evaluated were 50415000
A1. Four days postchallenge, animals were necropsied and individual lungs lungs individual and necropsied were animals postchallenge, days Four A1.
M. haemolytica M. type type of strain heterologous a with postvaccination 2 weeks
One Shot Ultra 8 were subjected to severe experimental challenge at at challenge experimental severe to subjected were 8 Ultra Shot One
challenge-of-immunity study. Cattle (300–550 lb) vaccinated with 1 dose of of dose 1 with vaccinated lb) (300–550 Cattle study. challenge-of-immunity
8 Ultra Shot One ®
M. haemolytica M. was demonstrated in a a in demonstrated was against 8 Ultra Shot One of Efficacy
in small, temporary injection site swellings. site injection temporary small, in
untoward reactions were noted following vaccination. Vaccination did result result did Vaccination vaccination. following noted were reactions untoward
In safety studies involving 595 animals, no no animals, 595 involving studies safety In EFFICACY: AND SAFETY
Visual Code Bars Code Visual
haemolytica type A1. (shipping fever). (shipping A1. type
NO COPY NO
Mannheimia Mannheimia areas of necrosis characteristic of pneumonia caused by by caused pneumonia of characteristic necrosis of areas Area for Vendor Supplied Vendor for Area Kalamazoo, MI 49007, USA 49007, MI Kalamazoo,
releases enzymes that add to the fibrinopurulent consolidation and local local and consolidation fibrinopurulent the to add that enzymes releases Zoetis Inc. Inc. Zoetis
produce leukotoxin, which kills the leukocyte. As the leukocyte dies, it it dies, leukocyte the As leukocyte. the kills which leukotoxin, produce
leukocyte is unable to destroy the bacterium, allowing the bacterium to to bacterium the allowing bacterium, the destroy to unable is leukocyte
When the bacterium is engulfed by a weakened leukocyte, the the leukocyte, weakened a by engulfed is bacterium the When neutrophils). 2
incapacitates leukocytes (alveolar macrophages and polymorphonuclear polymorphonuclear and macrophages (alveolar leukocytes incapacitates U.S. Veterinary License No. 190 No. License Veterinary U.S.
M. haemolytica type A1 may grow rapidly and produce a leukotoxin which which leukotoxin a produce and rapidly grow may A1 type
For veterinary use only use veterinary For ® population adds to the deposition of organisms in the lungs. In the lung, lung, the In lungs. the in organisms of deposition the to adds population One Shot Ultra 8
change in climate, viral infections). This rapid increase in bacterial bacterial in increase rapid This infections). viral climate, in change (888) 963-8471 (USA), (800) 461-0917 (Canada). 461-0917 (800) (USA), 963-8471 (888)
increases greatly in number when an animal undergoes stress (transport, (transport, stress undergoes animal an when number in greatly increases Technical inquiries should be directed to Zoetis Inc. Veterinary Services, Services, Veterinary Inc. Zoetis to directed be should inquiries Technical
M. haemolytica M.
type A1, a normal constituent of the bovine nasopharynx, nasopharynx, bovine the of constituent normal a A1, type
Am J Vet Res Vet J Am haemolytica 42(8):1383–1388, 1981. 42(8):1383–1388,
on bovine neutrophils. neutrophils. bovine on 50415000
rate. Pasteurella Pasteurella al: et Cytotoxic effects of of effects Cytotoxic R, Simonson C, Baluyut 2. Berggren K, K, Berggren
breathing, nasal discharge, reduced feed intake, fever, and increased pulse pulse increased and fever, intake, feed reduced discharge, nasal breathing, Comp Med Comp 46:341–349, 1982. 46:341–349,
infected cattle and may result in death. Clinical signs may include difficult difficult include may signs Clinical death. in result may and cattle infected Can J J Can treatment costs in feedlot calves: The Bruce County Beef Project. Project. Beef County Bruce The calves: feedlot in costs treatment
condition, known as shipping fever, often prevents optimal weight gain in in gain weight optimal prevents often fever, shipping as known condition, et al: et 1. Factors associated with mortality and and mortality with associated Factors D, Davis A, Meek , Martin S Martin
The disease disease The resulted in substantial economic losses in the cattle industry. cattle the in losses economic substantial in resulted REFERENCES: 1
M. haemolytica M. type A1 has has A1 type by caused Pneumonia DESCRIPTION: DISEASE
or the vaccine is not administered in accordance with label directions. label with accordance in administered not is vaccine the or GLUE PANEL
(Stimugen™) to enhance the immune response. immune the enhance to (Stimugen™) shipment or environmental conditions, are otherwise immunocompromised, immunocompromised, otherwise are conditions, environmental or shipment
Cl. perfringens types C and D, with a special, water-soluble adjuvant adjuvant water-soluble special, a with D, and C types
infectious disease, are malnourished or parasitized, are stressed due to due stressed are parasitized, or malnourished are disease, infectious
Cl. chauvoei, Cl. septicum, Cl. haemolyticum, Cl. novyi, Cl. sordellii, Cl. novyi, Cl. haemolyticum, Cl. septicum, Cl. chauvoei, Cl. and and protective immune response may not be elicited if animals are incubating an an incubating are animals if elicited be not may response immune protective
antigens. The liquid component consists of killed, standardized cultures of of cultures standardized killed, of consists component liquid The antigens. This product has been shown to be efficacious in healthy animals. A A animals. healthy in efficacious be to shown been has product This 10.
increase the production of leukotoxin and capsular and cell-associated cell-associated and capsular and leukotoxin of production the increase supportive therapy. supportive
M. haemolytica M. propagated to to propagated of cultures whole inactivated of preparation of epinephrine is recommended and should be followed with appropriate appropriate with followed be should and recommended is epinephrine of
and the epsilon toxoid of type D. The freeze-dried component is a a is component freeze-dried The D. type of toxoid epsilon the and As with many vaccines, anaphylaxis may occur after use. Initial antidote antidote Initial use. after occur may anaphylaxis vaccines, many with As 9.
problem in North America, immunity is provided by the beta toxoid of type C C type of toxoid beta the by provided is immunity America, North in problem milk production may occur following vaccination of lactating dairy cattle. dairy lactating of vaccination following occur may production milk
Cl. perfringens Cl. haemolytica type B is not a significant significant a not is B type Although A1. ype t . Field reports and a clinical study indicate that a transient reduction in in reduction transient a that indicate study clinical a and reports Field 8
Mannheimia Mannheimia types B, C, and D; and bovine pneumonia caused by by caused pneumonia bovine and D; and C, B, types Temporary local swelling at injection site may occur after administration. after occur may site injection at swelling local Temporary 7.
Cl. perfringens Cl. sordellii; Cl. by caused enteritis and enterotoxemia by caused Contains formalin as a preservative. a as formalin Contains 6.
Cl. novyi; Cl. haemolyticum; Cl. by caused disease black by gas-gangrene Not for use in sheep. in use for Not 5.
Cl. septicum; Cl. bacillary hemoglobinuria caused caused hemoglobinuria bacillary by caused edema malignant Do not vaccinate within 21 days before slaughter. before days 21 within vaccinate not Do 4.
Clostridium chauvoei; Clostridium cattle as an aid in preventing blackleg caused by by caused blackleg preventing in aid an as cattle
Sterilized syringes and needles should be used to administer this vaccine. this administer to used be should needles and syringes Sterilized 3.
One Shot Ultra 8 is for vaccination of healthy healthy of vaccination for is 8 Ultra Shot One DESCRIPTION: PRODUCT Use entire contents when first opened. first when contents entire Use 2.
adversely affect potency. Do not freeze. not Do potency. affect adversely
1 . Store at 2°–7°C. Prolonged exposure to higher temperatures may may temperatures higher to exposure Prolonged 2°–7°C. at Store
8 Ultra Shot One
®
PRECAUTIONS:
be employed. be Haemolytica Bacterin-Toxoid Haemolytica
Good animal husbandry and herd health management practices should should practices management health herd and husbandry animal Good 4.
One Shot One whenever subsequent stress or exposure is likely. is exposure or stress subsequent whenever Types C & D-Mannheimia D-Mannheimia & C Types ®
is recommended. Good management practices support revaccination with revaccination support practices management Good recommended. is
Novyi-Sordellii-Perfrin gens gens
Revaccination: Annual revaccination with a single dose of UltraChoice 8 8 UltraChoice of dose single a with revaccination Annual 3.
reexposure.
Septicum-Haemolyticum- Septicum-Haemolyticum-
Cl. haemolyticum Cl. haemolyticum repeat the dose every 6 months in animals subject to to subject animals in months 6 every dose the repeat
Code
followed by a second 2-mL dose of UltraChoice 8, 4–6 weeks later. For For later. weeks 4–6 8, UltraChoice of dose 2-mL second a by followed
Clostridium Chauvoei- Chauvoei- Clostridium
I2 of 5 5 of I2
Primary Vaccination: Primary Administer a single 2-mL dose to healthy cattle, healthy to dose 2-mL single a Administer 2.