Active ingredient
Inactivated bovine rotavirus strain TM-91
Serotype G6P1 Inactivated bovine coronavirus strain C-197
Escherichia coli strain EC/17 expressing adhesin F5 (K99)
 
Indications
Active immunisation of healthy pregnant cows and heifers to provide calves with passive immunity targeted at reducing mortality, and the incidence and severity of diarrhoea from gastrointestinal infections caused by enterotoxigenic Escherichia coli, Bovine rotavirus and Bovine coronavirus.
Passive immunity in calves starts with colostrum feeding and is dependent on calves receiving sufficient colostrum after birth.
 
Onset of immunity: Passive immunity in calves starts with colostrum feeding.
 
Dosage and administration
Route: Subcutaneously or Intramuscularly in the anterior third of the neck. Avoid inadvertent intravascular administration.
 
A single injection of 3 mL is to be given during each pregnancy 3-12 weeks before calving is expected.
 
- Common aseptic procedures should be used during vaccination
- Use only sterile syringes and needles.
- Allow the vaccine to come to 18 to 22°C before use.
- Shake well before and occasionally during administration.
 
Protection of calves depends on the presence of colostral antibodies (obtained from vaccinated cows) in the gut during the first weeks of life until the individual immune status of the calves is formed. An adequate intake of colostrum throughout first 2-3 weeks of life is required to optimise efficacy from vaccination. All calves must be supplied with a sufficient volume of colostrum within six hours after calving. The peak concentration of antibodies in the colostrum occurs between 0 and 24h after parturition. In herds with unfavourable epizooological situations, collecting colostrum from vaccinated mothers from the first 6 - 8 milkings is recommended. To maintain lactogenic immunity calves must be fed with stored colostrum (2.5 - 3 litres per day) for at least the first two weeks of life.
 
To optimise the decrease in calf morbidity and reduction of intensity of diarrhoea whole herd vaccination is required. All newborn calves must be fed with the antibody enhanced colostrum.
 
Pharmacodynamic Properties
This inactivated oil vaccine is prepared from chemically inactivated virus antigens derived from bovine rotavirus strain TM- 91 and bovine coronavirus strain C-197 propagated in the established cell cultures, and from Escherichia coli expressing adhesin F5 (K99) propagated in the liquid growth medium.The vaccine is designed to stimulate antibody production of pregnant cows against these antigens, which are then transferred to calves when fed colostrum/milk.
 
Best practice calf rearing, paying attention to facilities and hygiene, is recommended to maximise vaccine efficacy and minimise disease challenge.
 
Contraindications
Do not vaccinate ill or unhealthy animals.
 
Incompatibilities
Do not mix with any other vaccine or immunological product.
 
Adverse reactions (frequency and seriousness)
Occasionally a slight swelling up to 2 cm in diameter may be observed at the site of injection. It will reabsorb within 14 days of injection. If intravascular injection occurs, cerebral or cardiac embolism may occur resulting in staggering or even death.
 
Use during pregnancy
The medicinal product is designated for the use in cows in the last trimester of pregnancy.
 
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other
 
Overdose (symptoms, emergency procedures, antidotes), if necessary
Administration of a double dose can occasionally cause a slightly extended swelling.
 
Withholding periods
Milk: Nil 
Meat: Nil
 
Handling Precautions
Avoid breathing vapours. Wash hands thoroughly after handling. Use only outdoors or in a well-ventilated area. Wear protective gloves/eye protection. In case of inadequate ventilation wear respiratory protection
 
First Aid
If swallowed do NOT induce vomiting. For advice contact the National Poisons Centre 0800 POISON (0800 764 766) or a doctor immediately.
 
ACCIDENTAL SELF-INJECTION IS DANGEROUS:
Obtain immediate medical attention.
 
Disposal
Preferably dispose of product by use. Otherwise dispose of product, packaging and waste at an approved landfill or equivalent facility.
 
Other 
Store between 2-8 °C, protected from light. Do not freeze. 
Unbroached three years life to expiry
Once vial is broached, use contents within 10 days or discard.
 
Registered pursuant to the ACVM Act 1997, No. A10777
See www.foodsafety.govt.nz for registration conditions
 
Safety Data Sheet available upon request