1-NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:Bioveta, a.s., Komenského 212, Ivanovice na Hané,Czech Republic
2.NAME OF THE VETERINARY MEDICINAL PRODUCT
Biocan DHPPi+L lyophilisate for the preparation of injection suspension with diluent
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Composition-1 ml:
a)freeze-dried component
Active substances:
Virus febris contagiosae canis min. 103.0TCID50, max. 104.5TCID50
Virus laryngotracheitidis contagiosae canis min.103.5TCID50, max. 104.5TCID50
Parvovirus enteritidis canis min. 104.5TCID50, max. 105.5TCID50
Virus parainfluensis canis min. 103.0TCID50, max. 104.2TCID50
Excipient:
Nutrimentum pro lyophilisationead 1 ml
b) liquid component
Active substances:
Leptospira icterohaemorrhagiae inac. min. titre 32 defined MAT*)
Leptospira canicola inac. min. titre 32 defined MAT*)
Leptospira grippotyphosa inac. min. titre 32 defined MAT*)
*) geometrical mean of titres of specific antibodies defined by microagglutinationtest
Excipient:
Algeldrati suspensio
Nutrimentum ad cultivationem leptospirae
4.INDICATIONS
For the active immunization of dogs against distemper, infectious hepatitis, infectious
laryngotracheitis, parvovirosis, parainfluenza and the most frequently occurred leptospira
serovars (Leptospira icterohaemorrhagiae, Leptospira canicola, Leptospira grippotyphosa) in
dogs at the age of 8 weeks and above.
5.CONTRAINDICATIONS
Total pyrexial disease.
6.ADVERSE REACTIONS
Local reaction (like a pea in size) can be formed in the vaccine application spot that will disappear on its own accord within 3 weeks.
Hypersensitivity can occur only rarely.
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 OF ADMINISTRATION
1 ml irrespective of animal’s age, weight and breed.
Method of administration–subcutaneous, preferably in zone behind the shoulder-blade at theage of 8 weeks and above, the re-vaccination shall be done within 14-21 day.
Notes:
The vaccines in brackets (P, R, DP, DHPPi)–possibility of the alternative application of other vaccine of Biocan series.
The vaccines marked: +C, +L, +LR–possibility of the simultaneous or combined application with other vaccines.
Further possible vaccinations:
Biocan M plus–vaccine against Microsporum canis for dogs of age 8 weeks and above,
Biocan B–vaccine against Lyme disease for dogs of age 12 weeks and above,
Biocan T–vaccine against tetanus for dogs of age 12 weeks and above.
The vaccination scheme should be specified by the veterinarian in dependence on the infection situation and the level of the passive immunity obtained due to the colostric antibodies in the vaccinated individuals. The revaccination should be repeated every year in order to keep permanent immunity of the animals vaccinated.
9.ADVICE ON CORRECT ADMINISTRATION
Shake well the vial before use.
Only clinically healthy animals in a good nutrition condition can be vaccinated. Possible anti-parasitic treatment should be carried out atleast 10 days before the vaccination. The vaccinated animals should not be trained or exercised for one week after the vaccination.
10.WITHDRAWAL PERIOD
Not intended for food animals.
11.SPECIAL STORAGE PRECAUTIONS
Store in a dry and dark place at the temperature of 2-8oC.Do not freeze!
Keep out of the reach and sight of children.
12.SPECIAL WARNINGS
Do not use after the expiry date stated on the label.When diluted, the vaccine shall be used immediately.
13-SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
The packages and any remainders of the preparation are to be disposed of pursuant to the regulations in force.
14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
March2009
15.OTHER INFORMATION
Immunological properties:
After application of the vaccine to the animals body, antigens contained in the vaccine are identified as foreign particles and this is followed by activation of a large number of protection mechanisms in organism (macrophages, opsonins, interleukins, B-lymphocytes etc.), in result of which specific antibodies against antigen determinants contained in the vaccine are formed. These specific antibodies should prevent development of the disease in the event of infection.
Immunity is starting after 14 days after first vaccination and firm immunity is developed after further 14 days after re-vaccination.Primovaccinated animals are revaccinated at an interval of 14-21 days. Annual revaccination is recommended tomaintain immunity.
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