Summary of medicine characteristics - Versican Plus Pi/L4R
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
Active substances:
| Lyophilisate (live attenuated): | Minimum Maximum |
| Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 | 103.1 TCID50* 105.1 TCID50 |
Suspension (inactivated):
| Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089 Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB 1090 Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088 Rabies virus, strain SAD Vnukovo-32 | ALR** titre > 1:51 ALR** titre > 1:51 ALR** titre > 1:40 ALR** titre > 1:51 > 2.0 IU*** |
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* Tissue culture infectious dose 50 %.
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* * Antibody micro agglutination-lytic reaction.
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* ** International units.
Adjuvant:
| Aluminium hydroxide | 1.8 – 2.2 mg. |
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
The visual appearance is as follows:
Lyophilisate: spongy matter of white colour.
Suspension: pink colour with fine sediment.
4. CLINICAL PARTICULARS4.1 Target species
Dogs
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4.2 Indications for use, specifying the target species
Active immunisation of dogs from 8–9 weeks of age:
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– to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
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– to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,
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– to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae,
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– to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa and
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– to prevent mortality, clinical signs and infection caused by rabies virus.
Onset of immunity :
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– 2 weeks after a single vaccination from 12 weeks of age for rabies,
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– 3 weeks after completion of the primary course for CPiV and
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– 4 weeks after completion of the primary course for Leptospira components.
Duration of immunity :
At least three years following the primary vaccination course for rabies. At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components. Duration of immunity for rabies was demonstrated after one vaccination at 12 weeks of age.
4.3 Contraindications
None.
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4.4 Special warnings 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.
Vaccinate healthy animals only.
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4.5 Special precautions for use
Special precautions for use in animals
Do not use in animals that are showing signs of rabies or that are suspected of being infected with rabies virus.
The live attenuated virus vaccine strain CPiV may be shed by vaccinated animals following vaccination. However, due to the low pathogenicity of the 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.
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4.6 Adverse reactions (frequency and seriousness)
A transient swelling (up to 5 cm) may commonly be observed at the injection site following subcutaneous administration in dogs. This can be painful, warm or reddened. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination.
Anorexia and decreased activity are rarely observed.
Hypersensitivity reactions (e.g. gastrointestinal signs such as diarrhoea and vomiting, anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur rarely. If such a reaction occurs, appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition which may be life-threatening.
Systemic reactions such as lethargy, hyperthermia and general malaise may occur very rarely.
Clinical signs of immune-mediated diseases, such as haemolytic anaemia, thrombocytopenia or polyarthritis have been reported in very rare cases.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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4.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during the second and third stages of pregnancy. Safety of the product during the early stage of pregnancy and during lactation have not been investigated.
4.8 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.
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4.9 Amounts to be administered and administration route
Subcutaneous use.
Dose and route of administration :
Aseptically reconstitute the lyophilisate with the suspension. Shake well and administer immediately the entire content (1 ml) of the reconstituted product.
Reconstituted vaccine: pink/red, or yellowish colour with slight opalescence.
Primary vaccination scheme :
Two doses of Versican Plus Pi/L4R 3–4 weeks apart from 8–9 weeks of age. The second dose should not be given before 12 weeks of age.
Rabies:
The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies. Therefore, the first dose may be given using Versican Plus Pi/L4. In this case the second vaccination with Versican Plus Pi/L4R should not be given before 12 weeks.
However, in field studies 10% of sero-negative dogs did not show seroconversion (> 0.1 lU/ml) 3–4 weeks after single primary vaccination against rabies. Some animals may also not show titres > 0.5 IU/ml after the primary vaccination. Antibody titres drop over the course of the 3-year duration of immunity, although dogs are protected when challenged. In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of > 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres > 0.5 IU/ml).
In case of need, dogs younger than 8 weeks can be vaccinated as safety of this product has been demonstrated in 6-week old dogs.
Re-vaccination scheme :
A single dose of Versican Plus Pi/L4R should be given every 3 years. Annual re-vaccination is required for canine parainfluenza virus and Leptospira components. Therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No other adverse reactions other than those mentioned in section 4.6 were observed after administration of a 10-fold overdose of the vaccine. However, in a minority of animals pain was observed at the injection site immediately after administration of a 10-fold overdose of the vaccine.
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4.11 Withdrawal period(s)
Not applicable.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for canidae, live and inactivated viral and inactivated bacterial vaccines.
ATC vet code: QI07AJ.
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and rabies virus.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Lyophilisate :
Trometamol
Edetic Acid
Sucrose
Dextran 70
Suspension :
Sodium chloride
Potassium chloride
Potassium dihydrogen phosphate
Disodium phosphate dodecahydrate
Water for injection
6.2 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after reconstitution according to directions: use immediately.
6.4 Special precautions for storage
Store and transport refrigerated (2°C-8°C).
Do not freeze.
Protect from light.
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6.5 Nature and composition of immediate packaging
Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Type 1 glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
Pack sizes:
Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of suspension.
Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of suspension.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/14/173/001
EU/2/14/173/002
9.
Date of first authorisation: 31/07/2014.
Date of last renewal: