Canigen l4 Epar Product Information - en PDF
Canigen l4 Epar Product Information - en PDF
Canigen l4 Epar Product Information - en PDF
1
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Active substances:
Inactivated Leptospira strains:
- L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12- 3550-7100 U1
000)
- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni 290-1000 U1
(strain Ic-02-001)
- L. interrogans serogroup Australis serovar Bratislava (strain As-05-073) 500-1700 U1
- L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005) 650-1300 U1
1
Antigenic mass ELISA units.
Excipient:
Thiomersal 0.1 mg
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
Dogs.
4.3 Contraindications
2
None.
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.
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.
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 Canigen series from the same marketing authorisation holder (or
national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type
2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain
Cornell components for subcutaneous administration where authorised. The product information of
the relevant Canigen vaccines should be consulted before administration of the mixed product.
When mixed with these Canigen vaccines, the demonstrated safety and efficacy claims for Canigen
L4 are no different from those described for Canigen L4 alone. When mixed with Canigen vaccines
containing canine parainfluenza virus strain Cornell at annual revaccination, it has been established
3
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 Canigen series from the same marketing
authorisation holder (or national subsidiary) containing Bordetella bronchiseptica strain B-C2 and/or
canine parainfluenza virus strain Cornell components for intranasal administration where authorised.
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.
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 with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from
the same marketing authorisation holder (or national subsidiary) containing canine distemper virus
strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154
and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1 dose (1
ml) of Canigen L4. The mixed vaccines should be at room temperature (15°C - 25°C) before they
are administered by subcutaneous injection.
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.
Not applicable.
5. IMMUNOLOGICAL PROPERTIES
4
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 suggest that the vaccine may provide a degree of
cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae
and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
6. PHARMACEUTICAL PARTICULARS
Thiomersal
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Do not mix with any other veterinary medicinal products except those mentioned in section 4.8.
Shelf life of the veterinary medicinal product as packaged for sale: 21 months.
Shelf life after first opening the immediate container: 10 hours.
Shelf life after reconstitution of Canigen vaccines according to directions: 45 mins.
Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper
and sealed with a coded aluminium cap.
Pack sizes:
Plastic box with 10 or 50 vials of 1 ml (1 dose).
Cardboard box with 1 vial of 10 ml (10 doses).
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.
5
7. MARKETING AUTHORISATION HOLDER
EU/2/15/183/001-003
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (http://www.ema.europa.eu/).
Not applicable
6
ANNEX II
7
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Not applicable.
8
ANNEX III
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
BOX
Plastic box with 10, or 50 vials of 1 ml
Cardboard box with 1 vial of 10 ml
3. PHARMACEUTICAL FORM
4. PACKAGE SIZE
10x 1 ml (1 dose)
50x 1 ml (1 dose)
1x 10 ml (10 doses)
5. TARGET SPECIES
Dogs
6. INDICATION(S)
Subcutaneous use.
Read the package leaflet before use.
8. WITHDRAWAL PERIOD(S)
Not applicable.
11
9. SPECIAL WARNING(S), IF NECESSARY
EXP {month/year}
Once broached, use within 10 hours
Store in a refrigerator.
Do not freeze.
Protect from light.
14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LABEL
1 ml and 10 ml vial
Canigen L4
1 ml (1 dose)
10 ml (10 doses)
4. ROUTE(S) OF ADMINISTRATION
SC
5. WITHDRAWAL PERIOD(S)
Not applicable.
6. BATCH NUMBER
Lot {number}
7. EXPIRY DATE
EXP {month/year}
Once broached, use within 10 hours. (just for 10 ml vials)
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
Active substances:
Inactivated Leptospira strains:
- L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12- 3550-7100 U1
000)
- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni 290-1000 U1
(strain Ic-02-001)
- L. interrogans serogroup Australis serovar Bratislava (strain As-05-073) 500-1700 U1
- L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005) 650-1300 U1
1
Antigenic mass ELISA units.
Excipient:
Thiomersal 0.1 mg
Colourless suspension.
4. INDICATION(S)
16
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
5. CONTRAINDICATIONS
None.
6. ADVERSE REACTIONS
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.
If you notice any side effects,, even those not already listed in this package leaflet or you think that
the medicine has not worked, please inform your veterinary surgeon.
7. TARGET SPECIES
Dogs.
Subcutaneous use.
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.
17
For simultaneous use with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from
the same marketing authorisation holder (or national subsidiary) containing canine distemper virus
strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain
154, and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1
dose (1 ml) of Canigen L4. The mixed vaccines should be at room temperature (15°C - 25°C)
before they are administered by subcutaneous injection.
Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Not applicable.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
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.
Pregnancy:
Can be used during pregnancy.
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 Canigen series from the same marketing
authorisation holder (or national subsidiary) containing Bordetella bronchiseptica strain B-C2 and/or
canine parainfluenza virus strain Cornell components for intranasal administration where authorised.
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.
Incompatibilities:
Do not mix with any other veterinary medicinal products except the above mentioned vaccines.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures
should help to protect the environment.
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (http://www.ema.europa.eu/).
Pack sizes:
Plastic box with 10 or 50 vials of 1 ml (1 dose).
Cardboard box with 1 vial of 10 ml (10 doses).
Not all pack sizes may be marketed.
In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of
cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae
and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
For any information about this veterinary medicinal product, please contact the local representative
of the marketing authorisation holder.
België/Belgique/Belgien: Lietuva:
VIRBAC, VIRBAC,
1ère avenue 2065 m – L.I.D., 1ère avenue 2065 m – L.I.D.,
19
FR-06516 Carros, FR-06516 Carros,
France/ Frankrijk/Frankreich France,
Tel: + 33 (0) 4 92 08 73 00 Tel: + 33 (0) 4 92 08 73 00
Danmark: Malta:
VIRBAC, VIRBAC,
1ère avenue 2065 m – L.I.D., 1ère avenue 2065 m – L.I.D.,
FR-06516 Carros, FR-06516 Carros,
Frankrig, Franza,
Tel: + 33 (0) 4 92 08 73 00 Tel: + 33 (0) 4 92 08 73 00
Deutschland: Nederland:
VIRBAC, VIRBAC,
1ère avenue 2065 m – L.I.D., 1ère avenue 2065 m – L.I.D.,
FR-06516 Carros, FR-06516 Carros,
Frankreich, Frankrijk,
Tel: + 33 (0) 4 92 08 73 00 Tel: + 33 (0) 4 92 08 73 00
Eesti: Norge:
VIRBAC, VIRBAC,
1ère avenue 2065 m – L.I.D., 1ère avenue 2065 m – L.I.D.,
FR-06516 Carros, FR-06516 Carros,
Prantsusmaa, Frankrike,
Tel: + 33 (0) 4 92 08 73 00 Tlf: + 33 (0) 4 92 08 73 00
Ελλάδα: Österreich:
VIRBAC, VIRBAC,
1ère avenue 2065 m – L.I.D., 1ère avenue 2065 m – L.I.D.,
FR-06516 Carros, FR-06516 Carros,
Γαλλία, Frankreich,
Tel: + 33 (0) 4 92 08 73 00 Tel: + 33 (0) 4 92 08 73 00
España: Polska:
VIRBAC ESPAÑA S.A., VIRBAC,
Angel Guimerá 179-181, 1ère avenue 2065 m – L.I.D.,
ES-8950 Esplugues de Llobregat, FR-06516 Carros,
[email protected] Francja,
20
Tel: + 33 (0) 4 92 08 73 00
France: Portugal:
VIRBAC France, VIRBAC,
13ème rue – L.I.D., 1ère avenue 2065 m – L.I.D.,
FR-06517 Carros, FR-06516 Carros,
[email protected] França,
Tel: + 33 (0) 4 92 08 73 00
Hrvatska: România:
VIRBAC, VIRBAC,
1ère avenue 2065 m – L.I.D., 1ère avenue 2065 m – L.I.D.,
FR-06516 Carros, FR-06516 Carros,
Francuska, Franţa,
Tel: + 33 (0) 4 92 08 73 00 Tel: + 33 (0) 4 92 08 73 00
Ireland: Slovenija:
VIRBAC, VIRBAC,
1ère avenue 2065 m – L.I.D., 1ère avenue 2065 m – L.I.D.,
FR-06516 Carros, FR-06516 Carros,
France, Francija,
Tel: + 33 (0) 4 92 08 73 00 Tel: + 33 (0) 4 92 08 73 00
Italia: Suomi/Finland:
VIRBAC, VIRBAC,
1ère avenue 2065 m – L.I.D., 1ère avenue 2065 m – L.I.D.,
FR-06516 Carros, FR-06516 Carros,
Francia, Ranska/Frankrike,
Tel: + 33 (0) 4 92 08 73 00 Puh/Tel: + 33 (0) 4 92 08 73 00
Κύπρος: Sverige:
VIRBAC, VIRBAC,
1ère avenue 2065 m – L.I.D., 1ère avenue 2065 m – L.I.D.,
FR-06516 Carros, FR-06516 Carros,
Γαλλία, Frankrike,
Tel: + 33 (0) 4 92 08 73 00 Tel: + 33 (0) 4 92 08 73 00
21