Versican Plus Pi/L4R - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Versican Plus Pi/L4R 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

NAME OF THE VETERINARY MEDICINAL PRODUCT

Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each dose of 1 ml contains:

Active substances:

Lyophilisate (live attenuated):

Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15

Suspension (inactivated): Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089 Leptospira interrogans serogroup Canicola	ALR titre > 1:51
serovar Canicola, strain MSLB 1090 Leptospira kirschneri serogroup Grippotyphosa	ALR titre > 1:51
serovar Grippotyphosa, strain MSLB 1091 Leptospira interrogans serogroup Australis	ALR titre > 1:40
serovar Bratislava, strain MSLB 1088	ALR titre > 1:51
Rabies virus, strain SAD Vnukovo-32	> 2.0 IU
Adjuvant:
Aluminium hydroxide	1.8 – 2.2 mg.

Lyophilisate: spongy matter of white colour. Suspension: pink colour with fine sediment.

• 4. INDICATION(S)

Active immunisation of dogs from 8–9 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,

• – to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa and

• – to prevent mortality, clinical signs and infection caused by rabies virus.

Onset of immunity :

• – 2 weeks after a single vaccination from 12 weeks of age for rabies,

• – 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 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.

• 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/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 IU/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 and Leptospira components. Therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.

• 9. ADVICE ON CORRECT 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.

• 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 :

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.

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