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Date: Tuesday, October 27, 2020 3:56

Description: Virbac 2013
Release 4.34
Bovigen Scour Emulsion for injection for Cattle
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:Bovigen Scour Emulsion for injection for Cattle
Product index: Bovigen Scour Emulsion for injection for Cattle
Cattle - milk: Zero days
Cattle - meat: Zero days
Qualitative and quantitative composition
One dose of the vaccine (3 ml) contains:
Active substance:
Bovine rotavirus strain TM-91, serotype G6P1 (inactivated)≥ 6.0 log2 (VNT)*
Bovine coronavirus strain C-197 (inactivated)≥ 5.0 log2 (HIT)**
Escherichia coli strain EC/17 (inactivated)
expressing F5 (K99) Adhesin≥ 44.8 % of inhibition (ELISA)***
*VNT – virus neutralisation test (rabbit serology induced by 2/3 dose of vaccine)
**HIT – haemagglutination inhibition test (rabbit serology induced by 2/3 dose of vaccine)
***ELISA – Enzyme-linked immunosorbent assay (rabbit serology induced by 2/3 dose of vaccine)
Adjuvant: Montanide ISA 206 VG 1.6 ml
Excipients:
Formaldehydemax. 1.5 mg
Thiomersalmax. 0.36 mg
Pharmaceutical form
White liquid emulsion which may form a sediment during storage
Clinical particulars
Target species
Cattle (pregnant cows and heifers)
Indications for use
For the active immunisation of pregnant cows and heifers to raise antibodies against E. coli adhesion F5 (K 99) antigen, rotavirus and coronavirus. When calves are fed colostrum from vaccinated cows during the first week of life, these antibodies have been demonstrated to reduce the severity of diarrhoea caused by bovine rotavirus, bovine coronavirus and enteropathogenic E. coli F5 (K99) and to reduce the shedding of virus by calves infected with bovine rotavirus or bovine coronavirus.
Onset of immunity: Passive immunity commences with colostrum feeding and is dependent on calves receiving sufficient colostrum after birth.
Contra-indications
none
Special warnings for each target species
none
Special precautions for use
Vaccinate healthy animals only.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse reactions
A slight swelling of 5-7 cm in diameter at the site of injection is common, and may in some cases be accompanied initially by increased local temperature. Typically, such swelling resolves within 15 days.
Slight, transient increases in temperature (up to 0.8°C) may be observed within 24 hours of vaccination, resolving within 4 days after vaccination.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
This veterinary medicinal product is intended for use in the last trimester of pregnancy.
Interactions
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 or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
For intramuscular use.
Common aseptic procedures should be used during vaccination.
Only sterile syringes and needles should be used.
Allow the vaccine to reach room temperature before use. Shake well before and occasionally during use to ensure that the sediment is dissolved prior to administration.
One dose: 3 ml
One dose in the course of each pregnancy, given in the 12 – 3 week period before calving is expected.
Feeding of colostrum
The protection of calves depends on adequate ingestion of colostrum from vaccinated cows. Measures should be taken to ensure that calves receive sufficient amounts of colostrum within the first few days of life. If calves do not get enough antibodies through the colostrum soon after they are born, they will have failure of passive transfer of antibodies. It is important that all calves receive as much colostrum as possible from the first milking within the first six hours after calving. It is recommended that at least 3 litres of colostrum are fed within the first 24 hours and this amount is equivalent to approximately 10% of the weight of a calf.
To achieve optimum results and to reduce infection pressure on the farm, a whole herd cow vaccination policy should be adopted.
Overdose
Following the administration of an overdose, no adverse reactions other than those mentioned above
Withdrawal periods
Zero days
Pharmacological particulars
Immunological properties
Pharmacotherapeutic group: immunologicals for cattle, inactivated viral and inactivated bacterial vaccines, bovine rotavirus + bovine coronavirus + Escherichia coli
The vaccine is designed for stimulation of the active immunity of pregnant cows against the antigenic components included in the vaccine. The antibodies are transferred to the calf via colostrum.
Pharmaceutical particulars
Excipients
Montanide ISA 206 VG
Formaldehyde
Thiomersal
Eagle’s Minimum Essential Medium (MEM)
Disodium phosphate dodecahydrate
Sodium chloride
Potassium chloride
Potassium dihydrogen phosphate
Water for injection
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 10 hours
Special precautions for storage
Store in a refrigerator (2 - 8°C). Protect from light. Do not freeze.
Immediate packaging
Paper carton containing one glass vial, type I (15 ml, 90 ml) closed with chlorobutyl rubber stopper or one glass bottle, type I (450 ml) closed with bromobutyl rubber stopper sealed with aluminium cap.
Plastic bottles (450 ml) closed with chlorobutyl rubber stopper and sealed with aluminium cap without outer package.
Commercial sizes: 15 ml (5doses), 90 ml (30 doses), 450 ml (150 doses).
For packing of 90 ml and 450 ml respectively it is recommended to use automated dosing equipment to protect stopper against destruction by multi-piercing.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
FORTE Healthcare Ltd
Cougar Lane
Naul
Co Dublin
Ireland
Marketing Authorisation Number
Vm 27819/4005
Significant changes
Date of the first authorisation or date of renewal
30 April 2015
Date of revision of the text
February 2018
Any other information
Nil
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Bovigen Scour emulsion for injection for cattle
GTIN:--