Lyophilisate suspension for injection live attenuated Sheep Pox Virus strain RM-65 vaccine

STATMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
• Active substance:
Each dose contains a minimum of 102.5 TCID50 freeze-dried live attenuated Sheep Pox Virus strain RM-65.
• Other ingredients:
Bacteriological peptone, trehalose and nonfat dried milk powder.
INDICATIONS: PARKERS Sheep POX vaccine is used for prevention of sheep pox disease in sheep.
CONTRAINDICATIONS:
Do not vaccinate sick or stressed animals.
ADVERSE REACTIONS:
Very rare: a small nodular reaction may appear at the site of inoculation and disappears later.
If you notice any side effects please inform your veterinarian.
TARGET SPECIES: Sheep.
DOSAGE:
• Dosage is 1 ml per animal subcutaneously,
(preferably in the elbow region), at 2-3 months of age.
• Re-vaccinate the animals annually.
ADVICE ON CORRECT ADMINISTRATION:
• Apply usual aseptic procedures.
• Use only clean, antiseptic or disinfectant free materials for the preparation of the vaccine solution.
• Dissolve the freeze-dried pellet vaccine with cold and sterile solvent provided.
• Use 50 ml solvent for each 50 doses vaccine vial, 100 ml solvent for 100 doses vaccine vial and 200 ml solvent for 200 doses vaccine vial.
• Reconstitute the vaccine immediately before use.
• Use the vaccine immediately after
reconstitution (within two hours in cool conditions).
WITHDRAWAL PERIOD: Zero days.

SPECIAL STORAGE PRECAUTIONS:
• Store in a refrigerator (2°C-8°C).
• Protect from direct sunlight.
• Keep out of the reach and sight of children.
• The vaccine remains stable for 2 years from production date stated on the label under the recommended storage conditions.
• Shelf life after reconstitution: Use the vaccine within
2 hours after reconstitution.
SPECIAL WARNING(S):
Special warnings for each target species:
Vaccinate healthy animals only.
Special precautions for use in animals:Not applicable.
Special precautions to be taken by the person administering the medicinal product to animals:
Although PARKERS Sheep POX vaccine is not pathogenic for humans; care should be taken to avoid accidental injection.
Should accidental injection occur immediate
medical care should be sought.
Use during pregnancy, lactation, fertility:
If necessary sheep pox may be administered to pregnant ewes, which will transfer immunity for young lamb during the first 3 months of age.
Can be administered during lactation and breeding.
Interaction with other medicinal products and other forms of interaction:
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
A decision to use this vaccine before and after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Overdose: 10X dose of a vaccine:
Rare: a small nodular reaction may appear at the site of inoculation and disappears later.
If you notice any side effects please inform your veterinarian.
SPECIAL PRECAUTIONS FOR DISPOSAL:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
OTHER INFORMATION:
Sheep pox is a viral disease of sheep which causes serious economic losses in countries where it occurs. Clinically, it is characterized by generalized pox lesions throughout the skin and mucous membranes, a persistent fever, lymphadenitis, and often a focal viral pneumonia with lesions distributed uniformly throughout the lungs. Subclinical cases may occur.
Control measures are based on strict hygiene and vaccination of healthy susceptible animals.
PARKERS Sheep POX has the following characteristics:-
• Stable.
• Provides a satisfactory protection for at least one year against sheep pox infection.
• Vaccination is followed by a good immune response.
Package sizes:
Vials of: 50 doses 100 doses and 200 doses.