Bovilis Rotavec Corona vet.
Active substance
ATC code
Species
Cattle (pregnant cows and heifers).
Indications
For the active immunisation of pregnant cows and heifers to raise antibodies against E. coli adhesins F5 (K99) and F41, rotavirus and coronavirus. While calves are fed colostrum from vaccinated cows during the first two to four weeks of life, these antibodies have been demonstrated to:
- reduce the severity of diarrhoea caused by E. coli F5 (K99) and F41
- reduce the incidence of scours caused by rotavirus
- reduce the shedding of virus by calves infected with rotavirus or coronavirus.
Onset of Immunity: Passive protection against all active substances will commence from the start of colostrum feeding.
Duration of Immunity: In calves artificially fed with pooled colostrum, protection will continue until colostrum feeding ceases. In naturally suckled calves, protection against rotavirus will persist for at least 7 days and against coronavirus for at least 14 days.
Dose to be administered and administration route
Intramuscular or subcutaneous use.
Preferably administer the vaccine in the side of the neck.
Shake well before use. Syringes and needles should be sterilised before use and the injection should be made through an area of clean, dry skin taking precautions against contamination.
Strict precautions should be taken against contamination of the vaccine. The use of a multi-dose syringe is recommended to avoid excessive broaching of the stopper. Once a vial is broached for the first time it may be used once more during the next 28 days and then discarded immediately after that use.
Administration:
Administer a single dose of 2 ml per animal. The recommended site of injection is the side of the neck.
A single injection should be given during each pregnancy between 12 and 3 weeks before calving is expected.
Colostrum feeding:
Protection of calves depends on the physical presence of colostrum antibodies (from vaccinated cows) within the gut for the duration of the first 2 - 3 weeks of life until calves develop their own immunity. Thus, it is essential to ensure adequate colostrum feeding for the whole of this period to maximise the efficacy of vaccination. All calves must receive adequate colostrum from their dams within 6 hours of birth.
Suckled calves will continue to receive adequate colostrum naturally by feeding from vaccinated cows.
In the dairy herd colostrum/milk from the first 6 - 8 milkings of vaccinated cows should be pooled. The colostrum may be stored below 20 °C, but should be used as soon as possible as immunoglobulin levels may fall by up to 50% after storage for 28 days. Where possible, storage at 4 °C is recommended. The calves should be fed on this pool at the rate of 2½ to 3½ litres per day (according to body size) for the first two weeks of life.
Optimal results will be obtained if a whole herd cow vaccination policy is adopted. This will ensure that in calves the level of infection and consequent virus excretion is kept to a minimum and consequently the overall level of disease challenge on the farm is minimised.
Adverse reactions
Cattle (pregnant cows and heifers):
|
Very common (>1 animal / 10 animals treated): |
Injection site swelling1, injection site pain2, injection site warmth2, injection site granuloma3 Muscle inflammation4 Injection site abscess5 |
|
Common 1 to 10 animals / 100 animals treated: |
Elevated temperature6 |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Hypersensitivity reaction7 |
1 Intramuscular administration: Soft swelling raised up to 1 cm and a diameter of on average 6.5 cm (maximum of 25 cm). Swellings usually resorb within 14 to 21 days but may persist for 125 days.
Subcutaneous administration in the neck: Swelling raised up to 1 cm and ranged from 2x2 to 15x15 cm (LxW). Swellings usually resorb over time but may persist for 125 days.
2 Injection site pain and injection site warmth occur reportedly commonly, when administered intramuscularly.
3 After subcutaneous administration in the ischiorectal fossa.
4 Subcutaneous administration in the ischiorectal fossa resulted in granulomatous haemorrhagic inflammatory reaction in dermal and subdermal tissues with inflammation extending into the underlying muscular tissue.
5 Less than 1 cm in diameter after subcutaneous administration in the ischiorectal fossa.
6 Intramuscular administration: Average increase of 0.4 °C, with a maximum of more than 2.0 °C, returning to normal the day after vaccination.
Subcutaneous administration in the ischiorectal fossa: Average increase of 0.4 °C, with a maximum of more than 2.0 °C, returning to normal in one to two days after vaccination.
7 In such cases, appropriate treatment such as adrenaline should be administered without delay.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Dispensing
POM-VPS - Prescription Only Medicine – Veterinarian, Pharmacist, SQP
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Rotavec Corona emulsion for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
Active substances
|
Bovine rotavirus inactivated, strain UK-Compton, serotype G6 P5 |
≥ 874 U1 |
|
Bovine coronavirus inactivated, strain Mebus |
≥ 340 U2 |
|
E. coli strain CN7985, serotype O101:K99:F41 |
≥ 560 U3 |
1 Units as determined in the BRV potency ELISA
2 Units as determined in the BCV potency ELISA
3 Units as determined in the E. coli F5 (K99) potency ELISA
Adjuvants
|
Light mineral oil / emulsifier |
1.40 ml |
|
Aluminium hydroxide Excipients |
2.45 - 3.32 mg |
|
Thiomersal |
0.032 - 0.069 mg |
|
Formaldehyde |
≤ 0.34 mg |
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for injection. Off-white emulsion.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle (pregnant cows and heifers).
4.2 Indications for use, specifying the target species
For the active immunisation of pregnant cows and heifers to raise antibodies against
E. coli adhesins F5 (K99) and F41, rotavirus and coronavirus. While calves are fed colostrum from vaccinated cows during the first two to four weeks of life, these antibodies have been demonstrated to:
- reduce the severity of diarrhoea caused by E. coli F5(K99) and F41
- reduce the incidence of scours caused by rotavirus
- reduce the shedding of virus by calves infected with rotavirus or coronavirus.
Onset of Immunity: Passive protection against all active substances will commence from the start of colostrum feeding.
Duration of Immunity : In calves artificially fed with pooled colostrum, protection will continue until colostrum feeding ceases. In naturally suckled calves, protection against rotavirus will persist for at least 7 days and against coronavirus for at least 14 days. 4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
4.5 Special precautions for use
Particularly strict precautions should be taken against contamination of the vaccine.
Special precautions for use in animals Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/selfinjection 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 veterinary medicinal 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 ischaemic 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.
4.6 Adverse reactions (frequency and seriousness)
A soft swelling raised up to 1 cm was observed very commonly at the site of injection during safety and clinical studies. These swellings usually resorb within 14 to 21 days.
Hypersensitivity reactions were observed in spontaneous pharmacovigilance reports in very rare cases. In such cases, appropriate treatment such as adrenaline should be administered without delay.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy.
4.8 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 or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.9 Amounts to be administered and administration route
Intramuscular use.
Shake well before use. Syringes and needles should be sterilised before use and the injection should be made through an area of clean, dry skin taking precautions against contamination.
Strict precautions should be taken against contamination of the vaccine. The use of a multi-dose syringe is recommended to avoid excessive broaching of the stopper. Once a vial is broached for the first time it may be used once more during the next 28 days and then discarded immediately after that use.
Administration:
Administer a single dose of 2 ml per animal. The recommended site of injection is the side of the neck.
A single injection should be given during each pregnancy between 12 and 3 weeks before calving is expected.
Colostrum feeding:
Protection of calves depends on the physical presence of colostrum antibodies (from vaccinated cows) within the gut for the duration of the first 2 - 3 weeks of life until calves develop their own immunity. Thus, it is essential to ensure adequate colostrum feeding for the whole of this period to maximise the efficacy of vaccination.
All calves must receive adequate colostrum from their dams within 6 hours of birth.
Suckled calves will continue to receive adequate colostrum naturally by feeding from vaccinated cows.
In the dairy herd colostrum/milk from the first 6 - 8 milkings of vaccinated cows should be pooled. The colostrum may be stored below 20 °C, but should be used as soon as possible as immunoglobulin levels may fall by up to 50% after storage for 28 days. Where possible, storage at 4 °C is recommended. The calves should be fed on this pool at the rate of 2½ to 3½ litres per day (according to body size) for the first two weeks of life.
Optimal results will be obtained if a whole herd cow vaccination policy is adopted. This will ensure that in calves the level of infection and consequent virus excretion is kept to a minimum and consequently the overall level of disease challenge on the farm is minimised.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
On administration of an intramuscular injection of not more than double the recommended dose, a reaction no more severe than after administration of a single dose may occur.
4.11 Withdrawal period(s) Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated viral and inactivated bacterial vaccines for cattle.
ATCvet code: QI02AL01
The vaccine contains a rotavirus from group A (serotype G6 P5), a coronavirus and Escherichia coli F5(K99)-F41 pilus antigens. These components are inactivated and adjuvanted with mineral oil and aluminium hydroxide.
The vaccine is intended to stimulate active immunity in order to provide passive immunity to the progeny against active substances.
Passive protection against all active substances will commence from the start of colostrum feeding. In calves artificially fed with pooled colostrum, protection will continue until colostrum feeding ceases. In naturally suckled calves, protection against rotavirus will persist for at least 7 days and against coronavirus for at least 14 days.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Light mineral oil (Emulsifier)
Aluminium hydroxide
Thiomersal
Formaldehyde
Sodium thiosulphate
Sodium chloride
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
The content of the vial should not be used beyond 28 days after first broaching.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
After broaching and first use, store upright and refrigerated (2 – 8 °C) until the next vaccination event.
6.5 Nature and composition of immediate packaging
Type I glass vial with 2 ml, 10 ml, 40 ml or 100 ml, closed with a halobutyl rubber stopper and an aluminium cap.
PET (polyethylene terephthalate) vial with 10 ml, 40 ml, or 100 ml, closed with a halobutyl or nitrile chlorobutyl rubber stopper and an aluminium cap.
Pack sizes:
Cardboard box with 10 x 2 ml (10 x 1 dose).
Cardboard box with 1 x 10 ml (5 doses).
Cardboard box with 1 x 40 ml (20 doses).
Cardboard box with 1 x 100 ml (50 doses).
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
MSD Animal Health UK Limited
Walton Manor, Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm 01708/5113
9. DATE OF FIRST AUTHORISATION
16 March 2000
10. DATE OF REVISION OF THE TEXT
November 2022
Approved: 24 November 2022
| Art. Nr. | 01708/5113 |
|---|---|
| EAN | 8713184100474 |
