Biocan Novel Pi/L4, lyophilisate and solvent for suspension for injection for dogs
Canine live vaccine against parainfluenza and inactivated vaccine against four serovars of leptospirosis. Active immunization of dogs from 6 weeks of age.
|type of preparative:||Vaccines|
|target species animals:||Dog|
Composition per 1 ml dose:
Lyophilisate (live attenuated):
Canine Parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* - 105.1 TCID50*
Leptospira interrogans serogroup icterohaemorrhagiae serovar icterohaemorrhagiae, strain MSLB 1089 GMT**≥1:51 ALR***
Leptospira interrogans serogroup canicola serovar canicola, strain MSLB 1090 GMT**≥1:51 ALR***
Leptospira kirschneri serogroup grippotyphosa serovar grippotyphosa, strain MSLB 1091 GMT**≥1:40 ALR***
Leptospira interrogans serogroup australis serovar bratislava, strain MSLB 1088 GMT**≥1:51 ALR***
Adjuvant: aluminium hydroxide (quantifies as Al2O3) 1.8-2.2 mg
* Tissue culture infectious dose – 50%
** Geometric mean titre
*** Antibody micro agglutination-lytic reaction (serology in rabbits)
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Spongy matter, white colour.
Solvent: Whitish liquid with easily shakeable sediments.
Indications for use, specifying the target species:
Active immunization of dogs from 6 weeks of age.
- to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus
- to prevent clinical signs, infection and urinary excretion caused by L.interrogans serogroup australis serovar bratislava
- to prevent clinical signs and urinary excretion and reduce infection caused by L.interrogans serogroup canicola serovar canicola and L. interrogans serogroup icterhaemorhagiae serovar icterohaemorrhagiae
- to prevent clinical signs and reduce infection and urinary excretion caused by L.kirschneri serogroup grippotyphosa serovar grippotyphosa
Onset of immunity:
- 3 weeks after completion of the primary course for CPiV and
- 4 weeks after completion of the primary course for Leptospira components.
Duration of immunity:
At least one year following the primary vaccination course for all components of Biocan Novel Pi/L4.
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Special warning for each target species:
A good immune response is reliant on a fully competent immune system. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
Special precautions for use:
Special precautions for use in animals:
Only healthy animals should be vaccinated.
The live virus vaccine strain CPiV may be shed by vaccinated dog for a number of days following vaccination. Due to the low pathogenicity of this strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness):
Following subcutaneous administration in dogs, a small transient swelling (up to 5 cm) may commonly be observed at the injection site, these can occasionally be painful, warm or reddened. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination.
In rare cases gastrointestinal signs such as diarrhoea and vomiting or anorexia and decreased activity are possible.
As with any vaccine rare, occasional hypersensitivity reactions may occur. If such reaction occurs, appropriate treatment should be administered without delay.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports)
Use during pregnancy, lactation or lay:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore the use is not recommended during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction:
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route:
Dose and route of administration:
Aseptically reconstitute the lyophilisate with the solvent. Shake well and administer immediately the entire content (1 ml) of the reconstituted product .
Reconstituted vaccine: whitish or yellowish colour with slight opalescence.
Basic vaccination scheme:
Two doses of Biocan Novel Pi/L4 3-4 weeks apart from 6 weeks of age.
A single dose of Biocan Novel Pi/L4 to be given annually.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after reconstitution according to directions: administer the vaccine immediately.
Special precautions for storage:
Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Protect from light.
10 x 1 dose
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