NAMEANDADDRESS OF THE MARKETINGAUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:
Bioveta, a. s., Komenského 212, 683 23 Ivanovice na Hané, Česká republika
 NAME OF THE VETERINARYMEDICINAL PRODUCT
KOLIBIN RC Neo inj. ad us. vet.Inactivated vaccine against rota, corona and coli infections in newborn calves
3.STATEMENT OF THEACTIVE SUBSTANCE(S)AND OTHERINGREDIENT(S)
Each vaccination dose (2 ml) contains:
Active substances:
Rotavirus bovinum,

strainTM-91, inact.Coronavirus bovinum,  RP≥1*
strain C-197, inact.  RP≥1*

E- coli - 3 serovars of inactivated enteropathogenic strains – O8:K35, K99;
O9:K35, K99; O101:K30, K99RP≥1**) Relative potency established in guinea pigs by serological method (ELISA) in comparison
with standard vaccine with minimal content of
antigen
Excipient(s):

Thiomersalum                            0.01%

Formaldehyde solution 35%      0.19%
Adjuvant(s):

Oil adjuvans (Montanide ISA70)Ad 2 ml
4.INDICATION(S)
Active immunisation of pregnant heifers and cows for the purpose of passive immunisation of calves against gastro-enteric diseases caused by rotavirus, coronavirus and enteropathogenic E. coli strains.
Immunity onset:
In calves fed from mothers and in calves fed with colostrum collected from the vaccinated cows the passive protection starts when feeding begins.

Duration of immunity:
In calves fed with colostrum collected from the vaccinated cows lasts their passive protection against infection until feeding with colostrum is interrupted.
The calves fed from mothers are protected againsttheinfectionbycolostralandlactogenic immunity for the first 2 – 4 weeks of life.
5.CONTRAINDICATIONS
None.
6.ADVERSE REACTIONS
Hypersensitive reaction may occur rarely.In that case it is necessary to begin with appropriate treatment immediately.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
7.TARGET SPECIES
Cattle (pregnant heifers and cows).
8-DOSAGE FOR EACH SPECIES, ROUTE(S)AND METHOD OFADMINISTRATION
VaccineAdministration:
Vaccination dose – 2 ml
The vaccine is administered intramuscularly –preferably at gluteal region.
Immunityinducing:Thepregnantheifers(orstill unvaccinated cows) are vaccinated twice at the interval of 21 days, namely, 7 – 5 weeks and 4– 2 weeks before the first expected calving.
Feeding with Colostrum:
In order to ensure the effective prevention of calves against infection, the gastrointestinal tract of calves shall be saturated with colostrum obtained from the vaccinated cows for the first
2 – 3 weeks of their life.Acalf shall drink the adequate colostrum volume obtained from the vaccinated cows within 6 hours after its birth.
Taking into account that a calf is not fed with its mother, colostrum (and later milk) should be collected from the vaccinated cows during the first 6 – 8 milking; the colostrum and milk obtained as above should be stored either frozen or (for not later than 14 days) chilled to the temperature between 2 °C and 8 °C.The daily dose of colostrum (and, later, milk) for a calf is 2.5 – 3.5 l daily (depending on the size

of the calf) for at least the first two weeks oflife.
The optimum protection of calves against the infection can be reached using the method as mentioned above if all cows in the herd are vaccinated.
9.ADVICE ON CORRECTADMINISTRATION
Warm the vaccine to the temperature between 15°C – 25°C and shake the content of the vial before use.
10.WITHDRAWALPERIOD
Without withdrawal period.
11.SPECIALSTORAGE PRECAUTIONS
Keep out of the reach and sight of children.Store in a refrigerator (2oC – 8oC).
Protect from light. Protect from frost.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the container:
10 hours.
Do not use after the expiry date stated on the label.
12.SPECIALWARNING(S)
Vaccinate healthy animals only.The vaccine is destined for use in pregnant animals.
Special precautions for use in animals
All breeding animals in the stock should be vaccinated.Adequate colostrum volume shall be administered to calves not later than
6 hours after their calving.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.Adecision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
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 thisproduct, 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 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.
13-SPECIALPRECAUTIONS FOR THE DISPOSALOF UNUSED PRODUCT OR WASTE MATERIALS, IFANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
14-DATE ON WHICH THE PACKAGE LEAFLET WAS LASTAPPROVED
15/3/2018
15.OTHER INFORMATION
The vaccine is dispatched in hydrolytic glass I or II vials, or in plastic bottles conforming to Ph.Eur. sealed with pierceable rubber stoppers fitted with aluminium caps.
Package Size:
2x2ml,10x2ml,20x2ml,1x4ml,5x4ml,
10 x 4 ml, 1 x 10 ml, 5 x 10 ml, 10 x 10 ml,
1 x 20 ml, 5 x 20 ml, 10 x 20 ml, 1 x 50 ml,
12x50ml,24x50ml,1x100ml,12x100ml,
20 x 100 ml, 1 x 250 ml, 12 x 250 ml,
20 x 250 ml
Not all pack sizes may be marketed.
To be supplied only on veterinary prescription.
Imported by:
Biovet-Egypt,Egypt-Mansura City,
Slaughterhouse district ofAl Wahda street,Neighborhood trees - Nasreddine St. No.5