SUMMARY OF PRODUCT CHARACTERISTICS

1. name of the veterinary medicinal product

CANIGEN CHPPi/L lyophilisate and suspension for suspension for injection for dogs (FR)

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

CANIGEN DHPPi/L lyophilisate and suspension for suspension for injection for dogs (the other Member States)

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%

Suspension

Inactivated Leptospira interrogans serogroup canicola serovar canicola - strain 601903
conferring > 80% protection*
Inactivated Leptospira interrogans serogroup icterohaemorrhagiae serovar icterohaemorrhagiae - strain 601895
conferring > 80% protection*

*According to Eur. pharmacopeia monograph 447, Hamster potency test

Excipients

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Lyophilisate and suspension for suspension for injection.

Lyophilisate: White pellet

Suspension: Translucent liquid

4. Clinical particulars

4.1 Target species

Dog.

4.2 Indications for use, specifying the target species

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;

• prevent mortality and reduce infection, clinical signs, kidney colonisation, renal lesions and urine shedding of L. canicola;

• reduce infection, clinical signs, kidney colonisation and urine shedding of L. icterohaemorrhagiae;

Onset of immunity:

The onset of immunity has been demonstrated from 3 weeks after the primary vaccination for CDV, CAV-2 and CPV, 4 weeks for CAV-1 and CPiV, 5 weeks for L. canicola and 2 weeks for L. icterohaemorrhagiae.

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, in reduction of kidney colonisation for L. Canicola and L. icterohaemorrhagiae, nor in renal lesions and urine shedding for L. Canicola.

4.3 Contraindications

None.

4.4 Special warnings

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

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

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 and lactation

Do not use during pregnancy and lactation.

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 decided 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.

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 pinkish beige.

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 the 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

• ATCvet code QI07AI02

• Pharmacotherapeutic group: Immunologicals for Dog – Live viral and inactivated bacterial vaccines.

• To stimulate active immunity against canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus and L. interrogans serogroup canicola and L. interrogans serogroup icterohaemorrhagiae

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

Suspension :

Sodium hydroxide

Sucrose

Dipotassium phosphate

Potassium dihydrogen phosphate

Tryptone

Water for injections

6.2 Incompatibilities

Do not mix the vaccine with any other veterinary medicinal product.

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 suspension, both closed by a butyl-elastomer stopper and sealed with an aluminium cap, in a plastic or cardboard box.

Pack sizes:

1 vial of lyophilisate and 1 vial of suspension

10 vials of lyophilisate and 10 vials of suspension

25 vials of lyophilisate and 25 vials of suspension

50 vials of lyophilisate and 50 vials of suspension

100 vials of lyophilisate and 100 vials of suspension

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused 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

1^èreavenue - 2065m – LID

06516 Carros

France

8. Marketing authorisation number

Vm05653/4167

9. DATE OF FIRST AUTHORISATION

14 May 2012

10. DATE OF REVISION OF THE TEXT

July 2016

22 July 2016