Versican Plus Pi/L4 - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE VETERINARY MEDICINAL PRODUCT

Versican Plus Pi/L4 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

ALR ** titre > 1:51 ALR ** titre > 1:51 ALR ** titre > 1:40 ALR ** titre > 1:51

• * Tissue culture infectious dose 50%.

• * * Antibody micro agglutination-lytic reaction.

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: whitish colour with fine sediment.

4. CLINICAL PARTICULARS4.1 Target species

Dogs

• 4.2 Indications for use, specifying the target species

Active immunisation 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 Icterohaemorrhagiae serovar Icterohaemorrha­giae and

• – 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 Versican Plus Pi/L4.

4.3 Contraindications

None.

• 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.

• 4.5 Special precautions for use

Special precautions for use in animals

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.

• 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:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 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.

• 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 contents (1 ml) of the reconstituted product.

Reconstituted vaccine: pinkish or yellowish colour with a slight opalescence.

Primary vaccination scheme :

Two doses of Versican Plus Pi/L4 3–4 weeks apart from 6 weeks of age.

Re-vaccination scheme :

A single dose of Versican Plus Pi/L4 to be given annually.

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.

• 4.11 Withdrawal period(s)

Not applicable.

Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines. ATC vet code: QI07AI08.

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 and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrha­giae.

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 injections

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.

• 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 I 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.

• 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/2/14/172/001

EU/2/14/172/002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 31/07/2014.

Date of last renewal: 11/04/2019.