Product Name: POLIOVIN

Type: Clostridial Vaccine (Inactivated)

COMPOSITION

Each dose (2 ml for sheep/goats; 5 ml for cattle/camels) contains inactivated bacterial cultures with the following minimum antibody-inducing activity [citation:2][citation:3]:

• Clostridium perfringens type A and alpha toxoid ...... ≥ 2.5 IU anti-alpha*
• Clostridium perfringens type C and beta toxoid ...... ≥ 10 IU anti-beta*
• Clostridium perfringens type D and epsilon toxoid ...... ≥ 5 IU anti-epsilon*
• Clostridium novyi type B and toxoid ...... ≥ 3.5 IU anti-novyi*
• Clostridium septicum and toxoid ...... ≥ 2.5 IU anti-septicum*
• Fusobacterium necrophorum ...... ≥ 40 AU**
• Staphylococcus aureus ...... ≥ 0.5 AHU***
• Arcanobacterium pyogenes ...... ≥ 80 AU**

* IU = International Units (antibody titer in ml of serum)
** AU = Agglutinating Units
*** AHU = Antihemolytic Units

DESCRIPTION

POLIOVIN is a multivalent inactivated clostridial vaccine that provides broad-spectrum protection against major clostridial diseases and associated bacterial infections in livestock [citation:1]. The vaccine contains inactivated bacterial cultures and toxoids of nine different pathogens, stimulating active immunity against enterotoxemias, malignant edema, necrotic hepatitis, foot rot, and gangrenous mastitis [citation:2].

Clostridial Disease Overview: Clostridial bacteria are ubiquitous in the environment, found in soil, feces, and the intestinal tract of animals. These organisms form highly resistant spores that can survive for years in soil. Disease occurs when predisposing factors such as sudden dietary changes, intestinal stasis, or tissue injury allow rapid clostridial proliferation and production of potent exotoxins [citation:6].

Diseases Covered by POLIOVIN:

• Clostridium perfringens type A – Causes necrotic enteritis in chickens, necrotizing enterocolitis in pigs, and enterotoxemia in lambs and calves [citation:6]. Alpha toxin (lecithinase) causes hemolytic anemia and icterus [citation:7].
• Clostridium perfringens type C – Causes "struck" in adult sheep, characterized by sudden death or terminal convulsions. Beta toxin increases intestinal and capillary permeability, leading to jejunal ulceration and fluid accumulation in the peritoneal cavity [citation:6]. Also causes hemorrhagic enteritis in piglets, calves, and lambs [citation:7].
• Clostridium perfringens type D – Causes "pulpy kidney disease" or "overeating disease" in well-fed lambs (3-10 weeks old). Epsilon toxin increases intestinal and capillary permeability, leading to toxemia, convulsions, coma, and kidney autolysis with pulpy cortical softening [citation:6][citation:7].
• Clostridium novyi type B – Causes "black disease" (necrotic hepatitis) in sheep, typically following liver damage from liver fluke infestation.
• Clostridium septicum – Causes malignant edema (gas gangrene) in cattle, sheep, and goats, typically following wounds, injections, or parturition.
• Fusobacterium necrophorum – Primary cause of foot rot and hepatic abscesses in cattle and sheep.
• Staphylococcus aureus & Arcanobacterium pyogenes – Associated with gangrenous mastitis and other pyogenic infections [citation:2].

INDICATIONS
POLIOVIN is indicated for the active immunization of target animal species against infections caused by [citation:1][citation:2]:

• Enterotoxemias – Lamb dysentery (C. perfringens type B), struck (C. perfringens type C), and pulpy kidney disease (C. perfringens type D) [citation:6][citation:7]
• Malignant Edema – Gas gangrene caused by C. septicum [citation:2]
• Black Disease – Necrotic hepatitis caused by C. novyi type B [citation:2]
• Foot Rot – Infectious pododermatitis caused by Fusobacterium necrophorum [citation:2]
• Gangrenous Mastitis – Mastitis caused by S. aureus and A. pyogenes [citation:2]

DOSAGE & ADMINISTRATION

For subcutaneous (SC) administration only. Use aseptic technique. Shake well before use [citation:2].

Recommended Dosage by Species:

Vaccination Schedule:

• Primary Vaccination: Two doses administered 3 weeks (21 days) apart [citation:2].
• Booster Vaccination: A single dose every 12 months to maintain immunity [citation:2].
• Peak Immunity: Antibody titers reach their highest level at least 14 days after the second dose (revaccination) [citation:2].
• Duration of Immunity: At least one year following complete primary vaccination [citation:2].

Administration Route:

• Sheep & Goats: Subcutaneous injection into the knee fold, the neck area, or the chest behind the shoulder blade [citation:2].
• Cattle & Camels: Subcutaneous injection into the neck area [citation:2].
• Inject only where the skin is clean and dry to avoid the possibility of infection [citation:2].

WITHDRAWAL PERIODS

• Meat: 0 days [citation:2][citation:4]
• Milk: 0 hours [citation:4]

PRECAUTIONS & CONTRAINDICATIONS

• Do not use in animals infected with parasites, sick animals, or cachectic (emaciated) animals [citation:5].
• Do not administer immediately before transport or within 4 weeks after administration of glucocorticoids or antiserums [citation:5].
• Common Side Effects: Small local reactions at the injection site (swelling, pain) which resolve spontaneously [citation:5].
• Operator Safety: For veterinary use only. Avoid self-injection. In case of accidental self-injection, seek medical advice immediately.
• Storage: Store in a cool, dry place between 2°C and 8°C (refrigerated). Do not freeze. Protect from light.
• Shelf Life: 2 years [citation:4].
• Keep out of reach of children.

Target Species: Sheep, Lambs (over 3 months), Goats, Kids (over 3 months), Cattle, Calves, Camels [citation:2][citation:5]

Pack Sizes: 100 ml Vial [citation:2]

PRODUCT SUMMARY
POLIOVIN Clostridial Vaccine Vaccine Inactivated bacterial cultures: Cl. perfringens type A and alpha toxoid anti alpha 2.5 IU*, Cl. perfringens type C and beta toxoid anti-beta 10 IU*, Cl. perfringens type D anti-epsilon 5 IU*, Cl. novyi type B anti-novyi 3.5 IU, Cl. Septicum anti-septicum 2.5 IU*, Fusobacterium necrophorus 40 IU*, Staphylococcus aureus 0.5 AHU*, Arcanobacterium Pyogenes 80 AU* N Livestock 100ml Vial

FOR VETERINARY USE ONLY