1- NAMEANDADDRESS OF THE MARKETINGAUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Imported by: Biovet Egypt co.
Manufacturer: Bioveta, a. s., Komenského 212,683 23 Ivanovice na Hané, Czech Republic

 NAME OF THE VETERINARYMEDICINAL PRODUCT
Biocan DPlyophilisate for suspensionfor injection with diluent
Vaccine against canine distemper (CDV)and canine parvovirus (CPV-2), live
3. STATEMENT OF THEACTIVESUBSTANCE(S)AND OTHERINGREDIENT(S)
Composition – 1 ml:
A) Lyophilisate
Active substances:
Virus febris contagiosae canis:
103.0– 104.8TCID50
Parvovirus enteritidis canis:
104.5– 106.0TCID50
Excipients:
 lyophilisation mediumad 1 ml
B) Diluent:
 water for injection1 ml
TCID50– 50% infectious dose for tissue cultures.
4. INDICATIONS
For active immunization of dogs against canine distemper and canine parvovirus from the sixth week of age.
The onset of immunity is 14 to 28 days after the second vaccination.
The duration of immunity to both the antigens is at least one year.

5. CONTRAINDICATIONS
General febrile illness.
6.ADVERSE REACTIONS
In rare cases, the administration of the vaccine can induce subfebrile temperature rise and transient inappetence. Occasionally, it may cause hypersensitivity.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
7. TARGET SPECIES
Dogs.
8 . DOSAGE FOR EACH SPECIES, ROUTE(S)AND METHOD OFADMINISTRATION
Dose–1mlregardlessofage,weightand breedoftheindividual,butnotearlierthanatthesixthweekofage.
Methodofadministration–subcutaneous,preferablyintheregionbehindtheshoulder blade.
Eachdoseispreparedbydilutingthevialof lyophilisatewiththevialofdiluent.Thecontent ofthedilutedvaccineshouldbegentlyshaken andisintendedforimmediatesubcutaneous administration.
Recommended vaccination scheduleof Biocan
Vaccinationscheduleisdeterminedbya veterinarysurgeonaccordingtothedisease situationandthelevelofpassiveimmunityof individualsvaccinatedwithcolostralantibodies.Primovaccinatedindividualsyoungerthan
12weeksshouldberevaccinatedattheinterval of14–21days,withthelastrevaccinationafter
the13thweekofage.Annualrevaccinationis recommendedtomaintainpermanentimmunity.

Note:
Thevaccinesintheparentheses(P,R,DP,DHPPi)indicatethepossibilityofapplyingalternative vaccinesofBiocanseries.
Thevaccinesmarked+C, +L, +LRcanbeadministeredsimultaneouslyorconcurrentlycomother Biocanvaccines(e.g.DHPPi,DP,P,Puppy).
Otherpossiblevaccination:BiocanMplus–vaccineagainstMicrosporumcanisusablefromthe8thweekofage,BiocanB–vaccineagainstLymeborreliosisindogsusablefromthe12thweekofage,BiocanT–vaccineagainsttetanusfordogsusablefromthe12thweekofage.

9.ADVICE ON CORRECTADMINISTRATION
Vaccinateonlyclinicallyhealthyindividualsingoodnutritionalcondition.Anyantiparasitic treatmentshouldprecedevaccinationbyatleast10days.Trainingorotherstrenuous performanceisnotrecommendedinimmunized animalsforoneweekaftervaccination.
10. WITHDRAWALPERIOD
Notintendedforfood-producinganimals.
11. SPECIALSTORAGE PRECAUTIONS
Storeinadryanddarkplaceat2–8°C.Theproductmustnotbeusedaftertheexpiry
datestatedonthelabel.
Thevaccineshouldbeusedimmediatelyafter dilution.
12. SPECIALWARNING(S)
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Incaseofaccidentalself-injectionseekmedical adviceimmediatelyandshowthepackage leafletorlabeltoapractitioner.
Interaction with other veterinary medicinal products and other forms of interaction
BiocanDPcanbeusedseparately,orsimultaneouslywithliquidBiocanvaccines(LR,C,R,L)andconcurrentlywithBiocan vaccinesaccordingtotherecommended vaccinationschedule.
Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenadministered concurrentlywithotherveterinarymedicinal products,excepttheaforementionedproducts.Decisionaboutusingthisvaccinebeforeorafter anyotherveterinarymedicinalproductmustbe basedonconsiderationofindividualcases.
Theproductcanbeusedinpregnantorlactatingbitches.
13. SPECIALPRECAUTIONS FOR THE
DISPOSALOF UNUSED PRODUCT
OR WASTE MATERIALS, IFANY
Disposalofpackagingandanyremnantsoftheproductmustbecarriedoutinaccordancewithapplicableregulations.

 14-DATE ON WHICH THE PACKAGE LEAFLET WAS LASTAPPROVED
July 2018
 15-OTHER INFORMATIONImmunological properties:
Afterapplicationtothebodyofavaccinated individual,theantigensinthevaccineare recognizedasforeignandanumberofdefence mechanismsofthebodyareactivated(macrophages, opsonins, interleukins,B lymphocytes, etc.), which results in formation of specific antibodies against the antigenic determinants contained in the vaccine.
These mechanisms should prevent the subsequent development of infection.Maximum antibody levels are recorded between
the 14thand 28thday after vaccination and persist for a minimum period of 12 months.
Nature and contents of container
A/ Plastic box with a lid, with 10 wells:
5 × 1 ml of lyophilised vaccine Biocan DP+5 × 1 ml of diluent
B/ Plastic box with a lid, with 20 wells:
10 × 1 ml of lyophilised vaccine Biocan DP+10 × 1 ml of diluent
C/ Plastic box with a lid, with 100 wells:
50 × 1 ml of lyophilised vaccine Biocan DP+50 × 1 ml of diluent
Not all pack sizes may be marketed.