SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CANIGEN DHPPilyophilisate and solvent for suspension for injection for dogs

CANIGEN CHPPilyophilisate and solvent for suspension for injection for dogs (FR, NO)

VIRBAGEN CANIS SHAPPi lyophilisate and solvent for suspension for injection for dogs (AT, DE)

CANIXIN DHPPi lyophilisate and solvent for suspension for injection for dogs (DK, IE, UK)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 1 ml contains:

Active substances:

Lyophilisate :

Canine distemper virus (CDV) - Lederle strain	103.0 - 104.9 CCID50*
Canine adenovirus type 2 (CAV-2) - Manhattan strain	104.0 - 106.0 CCID50*
Canine parvovirus (CPV) - CPV780916 strain	105.0 - 106.8 CCID50*
Canine parainfluenza virus (CPIV) - Manhattan strain	105.0- 106.9 CCID50*
* Cell culture infectious dose 50%

Solvent:

Water for injections 1 ml

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection.

Lyophilisate: White pellet.

Solvent: Colourless liquid.

4. CLINICAL PARTICULARS

4.1 Target species

Dog

For active immunisation of dogs from 8 weeks of age to:

• prevent mortality and clinical signs caused by canine distemper virus;

• prevent mortality and clinical signs caused by canine adenovirus type 1;

• prevent clinical signs and mortality and reduce excretion caused by canine parvovirus in challenge studies performed with a CPV-2b strain;

• prevent clinical signs and reduce excretion caused by canine parvovirus in a challenge study performed with a CPV-2c strain

• reduce respiratory clinical signs and viral excretion caused by canine parainfluenza virus and canine adenovirus type 2;

Onset of immunity:

The onset of immunity has been demonstrated:

• From 3 weeks after the primary vaccination for CDV, CAV2 and CPV

• From 4 weeks after the primary vaccination for CPiV and CAV-1

Duration of immunity:

The duration of immunity lasts for one year after the primary vaccination for all components. For CPV and CAV-1, the duration of immunity was demonstrated by serological data. For CPV, it was shown that one year after the vaccination CPV-2 and CPV-2c antibodies are still present. In the duration of immunity studies there was no significant difference between vaccinated and control dogs in viral excretion for CPiV or CAV-2.

4.3 Contraindications

None.

4.4 Special warnings for each target species

The presence of maternally derived antibodies (puppies from vaccinated females) may in some cases interfere with the vaccination. Therefore the vaccination scheme should be adapted accordingly (see section 4.9).

4.5 Special precautions for use

Special precautions for use in animals

Apply usual aseptic procedures.

Vaccinate only healthy animals.

After vaccination, the live viral vaccinal strains (CAV-2, CPV) can be spread to unvaccinated animals without any pathological effect for these in-contact animals.

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)

After the administration of one dose of the product, a moderate local reaction which resolves spontaneously within 1 to 2 weeks may commonly be observed. This transient local reaction can be a swelling (≤ 4 cm) or slight diffuse local oedema, in rare cases associated with pain or pruritus.

Some transient post-vaccinal lethargic states are common. In rare cases hyperthermia or digestive disturbances such as anorexia, diarrhoea or vomiting may occur.

Very rare hypersensitivity reactions have been reported, in case of such an allergic or anaphylactic reaction, appropriate symptomatic treatment should be administered.

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).

4.7 Use during pregnancy, lactation or lay

Do not use during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Virbac’s Leptospira vaccine if available.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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

After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the following vaccination schedule:

Primary vaccination course:

- first injection from 8 weeks of age

- second injection 3 or 4 weeks later

When active immunisation against leptospira is also required, Virbac’s Leptospira vaccine can be used in place of the solvent. After reconstitution of one dose of the product with one dose of Virbac’s Leptospira vaccine, shake gently (the reconstituted product is slightly pinkish beige) and administer immediately one dose of 1 ml subcutaneously according to the same vaccination schedule: 2 injections 3 to 4 weeks apart from 8 weeks of age.

Annual re-vaccination:

One booster injection of a single dose should be given 1 year after the second injection and annually thereafter.

Maternally derived antibodies may in some cases influence the immune response to vaccination. In such cases, a third injection is recommended from 15 weeks of age.

The appearance of the reconstituted product is slightly pink.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The administration of a 10 fold overdose at a single injection site did not cause any reactions other than those mentioned in Section 4.6 ‘Adverse reactions’ except that the duration of local reactions was increased (up to 26 days).

4.11 Withdrawal period(s)

Not applicable.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for Dog - Live viral vaccines.

ATCvet code: QI07AD04

To stimulate active immunity against canine distemper virus, canine adenovirus, canine parvoviruses, canine parainfluenza virus.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lyophilisate:

Gelatin

Potassium hydroxide

Lactose monohydrate

Glutamic acid

Potassium dihydrogen phosphate

Dipotassium phosphate

Water for injections

Sodium chloride

Disodium phosphate anhydrous

Solvent:

Water for injections

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product, except those mentioned in 4.8.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf life after reconstitution according to directions: use immediately after reconstitution.

6.4 Special precautions for storage

Store and transport refrigerated (2 C – 8 C).

Protect from light.

Do not freeze.

6.5 Nature and composition of immediate packaging

Type I glass vial containing 1 dose of lyophilisate and type I glass vial containing 1 ml of solvent, both closed by a butyl-elastomer stopper and sealed with an aluminium cap, in a plastic or cardboard box.

Pack sizes:

1 vial lyophilisate and 1 vial solvent

5 vials lyophilisate and 5 vials solvent

10 vials lyophilisate and 10 vials solvent

25 vials lyophilisate and 25 vials solvent

50 vials lyophilisate and 50 vials solvent

100 vials lyophilisate and 100 vials solvent

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

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

7. MARKETING AUTHORISATION HOLDER

Virbac

1ère avenue - 2065m - LID

06516 Carros

France

8. MARKETING AUTHORISATION NUMBER

Vm 05653/4201

9. DATE OF FIRST AUTHORISATION

08 September 2016

10. DATE OF REVISION OF THE TEXT

September 2016

Approved: 08/09/2016