Versican Plus Pi/L4 - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

Manufacturer responsible for batch release :

Bioveta, a.s.,

Komenského 212,

683 23 Ivanovice na Hané,

CZECH REPUBLIC

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

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

Adjuvant:

Aluminium hydroxide

Tissue culture infectious dose 50%.

Antibody micro agglutination-lytic reaction.

Lyophilisate: spongy matter of white colour.

Suspension: whitish colour with fine sediment.

• 4. INDICATION(S)

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 the completion of 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.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

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).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Subcutaneous use.

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.

• 9. ADVICE ON CORRECT 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.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2°C-8°C).

Do not freeze.

Protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

Use immediately after reconstitution.

• 12. SPECIAL WARNING(S)

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.

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.

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.

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.

Overdose (symptoms, emergency procedures, antidotes) :

No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been 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.

Incompatibilities :

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION