Rotavec Corona THE ONLY VACCINE THAT PROTECTS AGAINST ROTAVIRUS, CORONAVIRUS AND E.COLI IN ONE SHOT

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1 Rotavec leaf:layout 1 13/12/ :47 Page 1 Rotavec Corona THE ONLY VACCINE THAT PROTECTS AGAINST ROTAVIRUS, CORONAVIRUS AND E.COLI IN ONE SHOT

2 Rotavec leaf:layout 1 13/12/ :47 Page 2 The Five Step Program Keeping herd performance on track means preventing and controlling neonatal diarrhoea. Evaluating herd and farm management practices, properly diagnosing pathogens and analyzing colostrum quality and intake are essential steps in resolving this costly problem. Selecting the right prevention / treatment protocol is also critical to success. > STEP 1 ASSESS PROBABLE CAUSES OF SCOURS In the process of investigating a case of neonatal diarrhoea on a farm, a thorough discussion with the cattle producer about farm calf management and type of animals affected can already identify a list of possible causes of the scour problem. Key areas for discussion Age of the animals affected Colostrum Management Calf feeding protocol Housing conditions Previous farm disease history Veterinary Health Plan Agent Escherichia coli (ECET) Age 1-5 days > STEP 2 UNDERTAKE FAECAL SAMPLING Enteric conditions caused by infectious microorganisms can be diagnosed from fresh faecal samples. When sampling a herd the following should be considered: Sample a group of at least five affected animals Collect faecal samples from the animal and not from the floor On site Diagnosis, an easy and quick option On site kits give a diagnosis within minutes of collecting the samples. Pathogens that can be tested for are: Rotavirus, Coronavirus, E. coli and C. parvum. Clostridium perfringens A/B/C Cryptosporidium parvum Rotavirus Coronavirus Giardia duodenalis 0-14 days 7-12 days 4-21 days 5-30 days 5-30 days Causes of diarrhoea and age at which calves are mostly affected. 2

3 Rotavec leaf:layout 1 13/12/ :47 Page 3 > STEP 3 EVALUATE COLOSTRUM INTAKE Colostral antibodies provide local protection in the gut of the calf but a portion is also absorbed into the blood stream. The capacity for absorption of antibodies is high during the first hours after birth and disappears once the calf is 24 hours old. The quality of the colostrum feeding regime can be evaluated by measuring the level of IgG in blood. Values of less than 10 g/l are indicative of inadequate colostrum intake. % Absorption > STEP 4 MEASURE COLOSTRUM QUALITY Inadequate colostrum intake can be the result of feeding poor quality colostrum. Colostrum quality can be measured using a colostrometer. The antibody level is measured in a sample of 250ml of colostrum. If colostrum does not contain sufficient antibody levels, action can be taken. Colostral antibodies can be boosted with vaccination. > STEP 5 DEFINE AND IMPLEMENT A PREVENTION/ TREATMENT PROTOCOL Actions following the diagnosis of neonatal diarrhoea on a farm are at three levels: Treatment of affected animals: rehydration (IV/oral), antibiotic and/or C. parvum treatment, NSAID S Colostrum management: corrective measures must be taken if problems are identified with the administration of colostrum to neonatal calves Prevention: implementation of vaccination protocols with Rotavec Corona and preventive use of halofuginone for the control of C. parvum 0 6 h 12 h 18 h 24 h Hours post calving Antibody absorption in calves during the first 24 hours of life. 3

4 Rotavec leaf:layout 1 13/12/ :47 Page 4 Rotavec Corona: High efficacy, outstanding convenience Rotavec Corona features outstanding efficacy against the main viral and bacterial enteric pathogens while delivering true convenience. Its single shot formula and broad window of vaccination (from 12 to 3 weeks prior to calving) makes it exceptionally well-suited to group vaccination. High efficacy demonstrated under laboratory and field conditions Single shot primary course Convenient group vaccination possible with the broad window of vaccination (12 to 3 weeks prior to calving) Low dose volume. Only 2 ml per dose Easy intramuscular administration of the product A practical range of presentations: 5 and 20 doses 12 weeks 3 weeks before calving before calving Calving Single Rotavec Corona Vaccination Rotavec Corona vaccination protocol for heifers and cows. 4

5 Rotavec leaf:layout 1 13/12/ :47 Page 5 Rotavec Corona Maternal Antibody Titres* MATERNAL ANTIBODY TITRES IN COLOSTRUM FROM DAIRY COWS VN tit res (log 2 ) Comparative evaluation of vaccination with Rotavec Corona and a second vaccine in the level of colostrum maternal antibodies of dairy cows. MATERNAL ANTIBODY TITRES IN COLOSTRUM FROM BEEF COWS VN titres (log 2 ) Rotavirus Coronavirus E. coli E.coli antibody titre (% inhibition) E.coli antibody titre (% inhibition) 3.5 Rotavirus Coronavirus E. coli Comparative evaluation of vaccination with Rotavec Corona and a second vaccine in the level of colostrum maternal antibodies of beef cows. Control Vaccine B Rotavec Corona *A.Recca et al Vet Record (2003) 152, Comparative lactogenic antibody responses of cattle from European field trials with a new enteric disease vaccine. 5

6 Rotavec leaf:layout 1 13/12/ :47 Page 6 The importance of optimum colostrum management A calf is born with no natural antibodies to fight enteric disease. The first milk produced by the cow is known as colostrum. It differs from normal milk in that it is richer in certain nutrients and contains high levels of antibodies. The administration of the right quantities of colostrum at the right time will reduce the vulnerability of the calf to different infectious pathogens. Key facts on Colostrum Management Volume and quality of colostrum The quality and volume of the colostrum can be influenced by different factors: breed, duration of dry cow period, lactation, age of the dam, heat stress The concentration of immunoglobulins in the colostrum decreases gradually during the first 24 hours after calving. The first colostrum has a higher concentration of immunoglobulins while colostrum collected 24 hours post calving contains very low levels. Vaccination of the dams with Rotavec Corona during the pre-calving period increases the level of antibodies against some of the most important enteric pathogens. Administration of colostrum The optimum time for colostrum administration is the first 4 hours post calving. After the first 6 hours the absorption capacity of the gut decreases and disappears by the time the calf is 24 hours old. From that moment on the immunoglobulins in the colostrum administered are only effective in the intestinal lumen. 4 litres of colostrum should be administered in the first 6 hours of life. if possible continue with 2L /12h x 3days or as long as possible The colostrum should be defrosted and warmed up to C immediately before feeding it to the calves. Temperatures above 60 C should be avoided as high temperatures destroy antibodies. 6

7 Rotavec leaf:layout 1 13/12/ :47 Page 7 Storage of colostrum To facilitate management of colostrum in the herd, most farms need to store colostrum after collection. This can be done by refrigeration or freezing. Pasteurized and refrigerated colostrum can be stored for up to 10 days. Frozen colostrum can be stored for a longer period (up to1 year) It is not recommended to mix colostrum from different dams as this can contribute to the spread of certain diseases within the herd. 7

8 Rotavec leaf:layout 1 13/12/ :47 Page 8 THE SINGLE SHOT VACCINE AGAINST NEONATAL DIARRHOEA Single shot primary course Broad window of vaccination (12 to 3 weeks prior to calving) Low dose volume (2 ml) Intramuscular administration Range of presentations (5 and 20 doses) EARLY CARE, LIFE LONG GAINS ROTAVEC CORONA - PRODUCT INFORMATION Presentation: AAwhite liquid emulsion vaccine for injection. Each 2dose ml dose contains: contains: Bovine Bovine rotavirus, rotavirus, strain strain UK-Compton, UK-Compton, serotype serotype G6 P5 G6 (inactivated), P5 (inactivated), a 1 /4 adose 1 4 vaccine of vaccine dose stimulatesa virus neutralising antibody titre: 7.7 log 2 pigs). 1 /20 dose of vaccine stimulates an ELISA antibody titre: 3.41 log 10 /ml (guinea pigs). E. coli F5 (K99) adhesion, 1 2 /ml (guinea pigs); Bovine coronavirus, strain Mebus (inactivated), a 1 20 vaccine dose stimulates an ELISA antibody titre: 3.41 log 10 /ml (guinea pigs); E. coli F5 (K99) adhesion, 1 20 vaccine /20 dose stimulates of vaccine stimulates an ELISA antibody ELISAOD492:> antibody 0.64 (OD492):> (guinea pigs) (guinea Also contains pigs). Thiomersal, light mineral oil ml, mg. aluminium Uses: For hydroxide the active immunisation mg, thiomersal, of pregnant cows and heifers mg andto formaldehyde raise antibodies 0.34 against mg. E. Uses: coli adhesin For the active F5 (K99) immunisation antigen, rotavirus of pregnant and coronavirus. cows and heifers While calves to raiseare antibodies fed colostrum against from E. coli vaccinated adhesincows F5 (K99) during antigen, the first rotavirus two to and fourcoronavirus. weeks of life, While these calves antibodies are fedhave colostrum been demonstrated from vaccinated to: reduce cows during the severity the first of two diarrhoea to four caused weeksby ofe. life. colithese F5 (K99), antibodies reduce have the incidence been demonstrated of scours caused to: reduce by rotavirus, the severity reduce ofthe diarrhoea shedding caused of virus by E. bycoli calves F5 (K99), infected reduce with rotavirus the incidence or coronavirus. of scours caused Dosage byand rotavirus, administration: reduce the shedding Dose: Cows of virus and heifers by calves 2 ml. infected Administration: with rotavirus By intramuscular or coronavirus. injection. DosageThe andrecommended administration: site Dose: is thecows side and of the heifers neck.the 2 ml. bottle Administration: should be well By intramuscular shaken before injection. any vaccine Theis recommended withdrawn. A site single is the injection side of should the neck. be given The bottle duringshould each pregnancy be well shaken between before 12 and any 3vaccine weeksisbefore withdrawn. calving Aissingle expected. injection Colostrum should be feeding: given during Protection each pregnancy of calves depends between on 12 the and physical 3 weeks presence beforeof calving colostrum is expected. antibodies Colostrum (from vaccinated feeding: Protection cows) within of calves the gut depends for the duration the physical of thepresence first 2 3ofweeks colostrum of life antibodies until calves (from develop vaccinated their own cows) immunity. within the Thus gut itfor is essential the duration to ensure of theadequate first 2-3 weeks colostrum of life feeding until calves for the develop wholetheir of this own period immunity. to maximise Thus itthe is essential efficacy to of ensure vaccination: adequate 1) All colostrum calves must feeding receive for adequate the whole colostrum of this period from to their maximise dams within the efficacy 6 hours of of vaccination: birth. Suckled 1) All calves will must continue receiveto adequate receive adequate colostrum colostrum from their naturally dams within by feeding 6 hours from of birth. vaccinated Suckled cows. calves 2) will In the continue dairy herd to receive colostrum/milk adequatefrom colostrum the first naturally 6-8 milkings by feeding of vaccinated from vaccinated cows should cows. be2) pooled. In the dairy 3) Theherd colostrum colostrum/milk may be stored from the befow first20 C 6-8 milkings but should of vaccinated be used as soon cows as should possible be pooled. as immunoglobulin 3) The colostrum levels may be fall stored by up to below 50% 20 C after but storage should for be 28 used days. aswhere soon as possible, storage as immunoglobulin at 4 C is recommended. levels may fall Theby calves up toshould 50% after then storage be fed on forthis 28 pool days. at Where the rate possible, of 21/2 storage 31/2atlitres 4 C is per recommended. day (according The to body calvessize) should for then first be fed twoon weeks this pool of life. at 4) theoptimal rate of results to 3will 1 2 litres be obtained per day (according if a wholeto herd body cowsize) vaccination for the first policy twoisweeks adopted. of life. This 4) will Optimal ensureresults that in will calves be obtained the level of if ainfection whole herd andcow consequent vaccination virus policy excretion is adopted. is kept This to a will minimum ensureand thatconsequently in calves the the level overall of infection level of and disease consequent challenge virus on excretion the farm is kept to a minimum. and Contra-indications, consequently the overall warnings: level of Warnings: disease challenge Do not vaccinate on the farm unhealthy is keptanimals. to a minimum. No information Contra-indications, is available warnings: on the concurrent Warnings: use of Dothis notvaccine vaccinate withunhealthy any other. animals. It is therefore No information recommended is available that noon other vaccine concurrent should use be of administered this vaccinewithin any 14 days other. before It is therefore after vaccination recommended with this thatproduct. no other Part vaccine used containers should be administered of the vaccine within should14 bedays discarded beforewithin after 8 hours vaccination of opening. with Side this product. effects: The Partoil used adjuvant containers provides of the vaccine convenience shouldofbe a single discarded shotwithin vaccine 8and hours hasof been opening. carefully Sidechosen effects: tothe minimise oil adjuvant any consequent provides side the convenience effects. It may ofproduce a single shot a detectable vaccine and swelling has been at the carefully site ofchosen injection to minimise a proportion any consequent of animals. side Theeffects. injection It may site produce reaction agradually detectable reduces swelling size at the until siteitof isinjection no longer indetectable, a proportion usually of animals. 14 to The 21 days injection after site treatment. reactionas gradually with allreduces vaccines inoccasional size until ithypersensitivity is no longer detectable, reactionsusually may occur. 14 to In 21such dayscases after treatment. appropriate As treatment with all vaccines such asoccasional adrenalinehypersensitivity should be administered reactions may without occur. delay. In such Withdrawal cases appropriate period: treatment Zero days. such Operator as adrenaline warning: should To the be user: administered If you inject without yourself delay. accidentally Withdrawal withperiod: this product, Zero days. go at Operator once the warning: nearest ToAccident the user: and If you Emergency inject yourself (Casualty) accidentally Department with this of a product, hospital go and atshow once the to the information nearest Accident printed and below Emergency to the doctor (Casualty) (or nurse) Department on duty. of To a the hospital doctor: andaccidental show the information self-injectionprinted with this below oil-based to theproduct doctor (or cannurse) cause on intense duty. vascular To the doctor: spasmaccidental which may, self-injection for example with result this inoil-based the loss of product a digit. can Expert causeprompt intense vascular surgical attention spasm which is required may, for and example may necessitate result in the early lossincision of a digit. andexpert irrigation PROMPT of thesurgical injected attention area, especially is required where and there mayis necessitate involvement early of finger incision pulp andor irrigation tendon sheaths. of the injected Pharmaceutical area, especially precautions: where there Store is involvement between +2 Cofand finger +8 Cpulp including or tendon during sheaths. transport. Pharmaceutical Protect from precautions: light. Do notstore freeze. between Rotavec+2 C Corona and should +8 C including not be mixed during with transport. other medicaments Protect fromor light. vaccines. Do not Packaging freeze. Rotavec Quantities: Corona10 should ml bottle not (5 bedoses), mixed with 40 mlother bottle medicaments (20 doses). Further or vaccines. information: Packaging1) Quantities: Calf diarrhoea 10 ml isbottle a complex (5 doses), disease 40of ml which bottle rotavirus, (20 doses). coronavirus and E. coli, are three of the most important causal agents in calves in the first few weeks of life. The vaccine will aid in reducing the incidence of scours caused by rotavirus, coronavirus and E. coli where these are the sole aetiological agents. The vaccine provides no protection against cryptosporidia (for which there is currently no vaccine), but often mixed infections occur and it may help to some degree by providing protection against any concurrent rotavirus, coronavirus and E. coli F5 (K99) infections. The presence of each agent can be confirmed by laboratory sampling of fresh faeces samples (not swabs) taken directly from calves before any treatment. As the level of passive protection induced by the vaccine is not absolute, coronavirus and rotavirus infections may occur in calves from vaccinated dams but will be contained whilst the calf is mounting its own active immune response against the viruses. 2) F5 (K99) antigen enables E. coli to adhere to the calfs small intestine where the bacteria multiply rapidly and produce toxins leading to scours, typically in the first few days of life. Specific antibodies can inhibit E. coli sticking to the gut wall and thereby their ability to cause disease. The E. coli F5 (K99) antigen in Rotavec Corona promotes the production of antibodies in colostrum and milk. 3) In any animal population there may be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine together with the animals ability to respond. This can be influenced by such factors as genetic constitution, intercurrent infection, age, the presence of maternally-derived antibodies, nutritional status, concurrent drug therapy and stress. Product Licence Number: EU/2/99/013/001 Legal Category in ROI: POM Legal Category in Nth. Irl.: POM-VPS Use Medicines Responsibly PM09_0095 R , Intervet International bv Further information is available from your veterinary surgeon or: MSD Animal Health, Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland. Tel: +353(0)

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