Nobivac L4 - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobivac L4 suspension for injection for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 1 ml contains:

Active substances:

Inactivated Leptospira strains:

• - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12–000)         3550–7100 U1

• - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni                 290–1000 U1

(strain Ic-02–001)

L. interrogans serogroup Australis serovar Bratislava (strain As-05–073)

L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01–005) 1 Antigenic mass ELISA units.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

Colourless suspension.

4. CLINICAL PARTICULARS4.1 Target species

Dogs.

• 4.2 Indications for use, specifying the target species

For active immunisation of dogs against:

• - L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion

• - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion

• - L. interrogans serogroup Australis serovar Bratislava to reduce infection

• - L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion.

Onset of immunity: 3 weeks.

Duration of immunity: 1 year.

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

Vaccinate healthy animals only.

• 4.5 Special precautions for use

Special precautions for use in animals Not applicable.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Avoid accidental self-injection or contact with the eyes. In case of ocular irritation seek medical advice immediately and show the package leaflet or the label to the physician.

• 4.6 Adverse reactions (frequency and seriousness)

A mild and transient increase in body temperature (< 1 °C) has been observed very commonly in clinical studies for a few days after vaccination, with some pups showing less activity and/or a reduced appetite. A small transient swelling at the site of injection (< 4 cm), which can occasionally be firm and painful on palpation, has been observed very commonly in clinical studies. Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination.

In very rare cases, clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia, or immune-mediated polyarthritis have been reported. In very rare cases a transient acute hypersensitivity reaction may occur. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening. If such reactions occur appropriate treatment is recommended.

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).

• 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

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac series containing canine distemper virus, canine adenovirus type 2, canine parvovirus (strain 154) and/or canine parainfluenza virus components for subcutaneous administration. The product information of the relevant Nobivac vaccines should be consulted before administration of the mixed product. When mixed with these Nobivac vaccines, the demonstrated safety and efficacy claims for Nobivac L4 are no different from those described for Nobivac L4 alone. When mixed with Nobivac vaccines containing canine parainfluenza virus at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Nobivac series containing Bordetella bronchiseptica and/or parainfluenza virus components for intranasal administration.

Safety data are available which demonstrate that this vaccine can be administered at the same time but not mixed with the inactivated vaccine of the Nobivac series against Bordetella bronchiseptica.

When this vaccine is administered in association with the inactivated vaccine of the Nobivac series against Bordetella bronchiseptica the demonstrated antibody response data and other immunity data of this vaccine are the same as when this vaccine is administered alone.

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

Subcutaneous use.

Before use, ensure that the vaccine is at room temperature (15 °C – 25 °C).

Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.

Vaccination scheme:

Basic vaccination: The first vaccination can be administered from 6 to 9() weeks of age and the second vaccination from 10 to 13 weeks of age.

Revaccination: Dogs should be re-vaccinated annually with one dose (1 ml) of vaccine.

• () In case of high level of maternally derived antibodies, first vaccination is recommended at

• 9 weeks of age.

For simultaneous use, 1 dose of a Nobivac vaccine containing canine distemper virus, canine adenovirus type 2, canine parvovirus (strain 154), and/or canine parainfluenza virus components should be reconstituted with 1 dose (1 ml) of Nobivac L4. The mixed vaccines should be at room temperature (15 °C – 25 °C) before they are administered by subcutaneous injection.

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

No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine. However, these reactions may be more severe and/or last longer. For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.

• 4.11 Withdrawal period

Not applicable.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccines.

ATCvet code: QI07AB01.

To stimulate active immunity in dogs against L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang.

In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of crossprotection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Sodium chloride

Potassium chloride

Disodium phosphate dihydrate

Potassium dihydrogen phosphate

Water for injections

6.2 Major incompatibilities

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

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 21 months.

Shelf life after first opening the immediate packaging: use immediately.

Shelf life after reconstitution of Nobivac vaccines according to directions: 45 mins.

6.4. Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Protect from light.

• 6.5 Nature and composition of immediate packaging

Type I glass vial of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.

Pack sizes:

Plastic box with 5, 10, 25 or 50 vials of 1 ml (1 dose).

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

7. MARKETING AUTHORISATION HOLDER

Intervet International B.V.

Wim de Korverstraat 35

5831 AN Boxmeer

The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/12/143/001–004

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16/07/2012.

Date of last renewal: 13/03/2017.