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Date: Sunday, May 26, 2024 11:35

Release 8.111
Canigen Lepto 4 suspension for injection for dogs (GB Only)
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Canigen Lepto 4 suspension for injection for dogs (GB only)
Product index: Canigen Lepto 4 suspension for dogs (GB)
Incorporating:
Qualitative and quantitative composition
Active substances
Each dose of 1ml contains inactivated Leptospira strains:
- L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000) 3550-7100 U1
- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001) 290-1000 U1
- 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.
List of excipients
Sodium chloride
Potassium chloride
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Water for injections
Pharmaceutical form
Colourless suspension for injection
Clinical particulars
Target species
Dogs
Indications for use
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
Contra-indications
None
Special warnings for each target species
Special precautions for use in animals:
Vaccinate only healthy animals.
Special precautions for use
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.
Adverse reactions
Dogs:
Very common (>1 animal / 10 animals treated):
Injection site swelling1,
Injection site nodule1,
Injection site pain2,
Elevated temperature3,
Decreased activity4,
Decreased appetite4.
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Hypersensitivity reactions5,
Immune mediated haemolytic anaemia,
Immune mediated thrombocytopenia,
Immune mediated polyarthritis.
1 ≤ 4 cm; subsides within 14 days.
2 Subsides within 14 days.
3 ≤ 1 °C, up to 3 days.
4 In pups.
5 Reactions are transient. This includes anaphylaxis (sometimes fatal). If such reaction occurs, appropriate treatment should be administered without delay.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Use during pregnancy, lactation or lay
Can be used during pregnancy
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines in the Canigen range 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 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 Lepto 4 are no different from those described for Canigen Lepto 4 alone. When mixed with Canigen 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 in the Canigen range 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 in the Canigen range against Bordetella bronchiseptica. When this vaccine is administered in association with the inactivated vaccine in the Canigen range 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.
Amounts to be administered and administration route
Subcutaneous use.
Before use, ensure that the vaccine is at room temperature (15 oC – 25oC).
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 schedule
Primary 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 Canigen 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 this vaccine. The mixed vaccines should be at room temperature (15 oC– 25oC) before they are administered by subcutaneous injection.
Overdose
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.
Withdrawal periods
Not applicable
Pharmacological particulars
Immunological properties
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.
Pharmaceutical particulars
Excipients
Sodium chloride,
potassium chloride,
disodium phosphate dihydrate,
potassium dihydrogen phosphate,
water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal products except those mentioned above.
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 Canigen vaccines according to directions: 45 minutes.
Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Protect from light.
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 10 or 50 vials of 1 ml (1 dose).
Not all pack sizes may be marketed.
Disposal
Medicines should not be disposed of via wastewater Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
MSD Animal Health UK Limited
Walton Manor
Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
Marketing Authorisation Number
Vm 01708/5030
Significant changes
Date of the first authorisation or date of renewal
03/07/2015
Date of revision of the text
September 2023
Any other information
Canigen Lepto 4 is not marketed in Northern Ireland as this authorisation only applies to GB.
Legal category
Legal category: POM-V
GTIN
GTIN description:Canigen L4 vaccine for dogs 50 dose
GTIN:8713184139658
GTIN description:Canigen L4 vaccine for dogs 10 dose
GTIN:8713184139641