Eurican Lmulti Suspension For Injection
Revised: July 2016
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:
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
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
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.
4.4 Special warnings for each target species
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.
Adverse reactions (frequency and seriousness)
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)
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 dihydrogen phosphate
Disodium phosphate dihydrate
Water for injections
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
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
10 December 2015
10. DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, SUPPLY AND/OR USE
Approved: 27 July 2016
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