SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Eurican Lmulti Suspension for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (1ml) of suspension contains:

Active substances:

InactivatedLeptospira interrogans serogroupand serovar Canicola

strain 16070 Activity acc. to Ph. Eur.447*

InactivatedLeptospira interrogans serogroup and serovar Icterohaemorrhagiae

strain16069 Activity acc. to Ph. Eur.447*

Inactivated Leptospira interrogans serogroup and serovarGrippotyphosa

strain GrippoMal 1540 Activity acc. to Ph. Eur.447*

*80% protection in hamsters

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

Opalescent and homogenous suspension

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Active immunisation of dogs to:

• prevent mortality, clinical signs, infection, bacterial excretion, renal carriage and renal lesions caused by Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae

• prevent mortality* and clinical signs, reduce infection, bacterial excretion, renal carriage and renal lesions caused by Leptospira interrogans serogroup Canicola serovar Canicola.

• prevent mortality*, and reduce clinical signs, infection, bacterial excretion renal carriage and renal lesions caused by Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa.

Onset of immunity: 2 weeks for all strains.

Duration of immunity: at least one year after the second injection of the primary vaccination course for all strains.

* For LeptospiraCanicola and Grippotyphosa, no mortality occurred during challenge experiment for duration of immunity.

4.3 Contraindications

None

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals.

Apply usual aseptic procedures.

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.

Immediately after injection, a slight swelling (≤ 2 cm) at the injection site may commonly be observed, usually regressing within 1-6 days. This can, on some occasions, be accompanied by slight pruritus, heat and pain at the injection site. Transient lethargy and emesis may also be observed.

Uncommon reactions such as anorexia, polydipsia, hyperthermia, diarrhoea, muscle tremor, muscle weakness and injection site cutaneous lesions may be observed.

As with any vaccine, rare hypersensitivity reactions may occur. In such cases, appropriate symptomatic treatment should be provided.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reaction(s) 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

Can be used during pregnancy

4.8 Interaction with other medicinal products and other forms of interaction

The product can be mixed with Merial live attenuated vaccines against distemper, adenovirosis, parvovirosis and parainfluenza type 2 respiratory infections.

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Merial's rabies vaccine in dogs from 12 weeks of age. In that case, the efficacy against LeptospiraIcterohaemorrhagiae was demonstrated only for the reduction of renal lesions and bacterial excretion, and the efficacy against Leptospira Grippotyphosa was demonstrated only for the reduction of renal carriage, renal lesions and bacterial excretion.

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

When Lmulti is used alone, inject a 1-ml dose subcutaneously

When Lmulti is used as a diluent of a Merial freeze-dried vaccine, aseptically reconstitute the contents of the lyophilisate with the suspension for injection. Shake well before use. The entire contents of the reconstituted vial should be administered as a single dose.

The following schedule should be followed:

Primary vaccination: Two injections separated by an interval of 4 weeks from 7weeks of age.

Revaccination: Administer one dose 12 months after completion of the primary vaccination course. Dogs should be revaccinated with a single booster dose on an annual basis.

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 2-fold overdose of the suspension.

4.11 Withdrawal period(s)

Not applicable.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivated bacterial vaccines

ATCvet code: QI07AB01

Vaccine against Leptospira (inactivated) in dogs.

After administration, the vaccine induces an immune response against Leptospira interrogans serogroup Canicola, Leptospira interrogans serogroup Icterohaemorrhagiae and Leptospirakirschneriserogroup Grippotyphosa leptospirosis in the dog demonstrated by challenge.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Potassium chloride

Sodium chloride

Potassium dihydrogen phosphate

Disodium phosphate dihydrate

Water for injections

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product except those listed in section 4.8.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening the immediate packaging: 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 vials with chlorobutyl stoppers, sealed with aluminium caps.

Plastic box of 10 vials (glass) of suspension (1 ml).

Plastic box of25 vials (glass) of suspension (1 ml).

Plastic box of 50 vials (glass) of suspension (1 ml).

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 products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Merial Animal Health Limited

PO Box 327, Sandringham House

Harlow Business Park

Harlow

Essex

CM19 5TG

8. MARKETING AUTHORISATION NUMBER

Vm 08327/4264

9. DATE OF FIRST AUTHORISATION

10 December 2015

10. DATE OF REVISION OF THE TEXT

July 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable

Approved: 27 July 2016