Canixin Dhppi Lyophilisate And Solvent For Suspension For Injection For Dogs
Issued: September 2016
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
CANIGEN DHPPilyophilisate and solvent for suspension for injection for dogs
CANIGEN CHPPilyophilisate and solvent for suspension for injection for dogs (FR, NO)
VIRBAGEN CANIS SHAPPi lyophilisate and solvent for suspension for injection for dogs (AT, DE)
CANIXIN DHPPi lyophilisate and solvent for suspension for injection for dogs (DK, IE, UK)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
Canine distemper virus (CDV) - Lederle strain
103.0 - 104.9 CCID50*
Canine adenovirus type 2 (CAV-2) - Manhattan strain
104.0 - 106.0 CCID50*
Canine parvovirus (CPV) - CPV780916 strain
105.0 - 106.8 CCID50*
Canine parainfluenza virus (CPIV) - Manhattan strain
105.0- 106.9 CCID50*
* Cell culture infectious dose 50%
Water for injections 1 ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: White pellet.
Solvent: Colourless liquid.
4. CLINICAL PARTICULARS
4.1 Target species
Indications for use, specifying the target species
For active immunisation of dogs from 8 weeks of age to:
prevent mortality and clinical signs caused by canine distemper virus;
prevent mortality and clinical signs caused by canine adenovirus type 1;
prevent clinical signs and mortality and reduce excretion caused by canine parvovirus in challenge studies performed with a CPV-2b strain;
prevent clinical signs and reduce excretion caused by canine parvovirus in a challenge study performed with a CPV-2c strain
reduce respiratory clinical signs and viral excretion caused by canine parainfluenza virus and canine adenovirus type 2;
Onset of immunity:
The onset of immunity has been demonstrated:
From 3 weeks after the primary vaccination for CDV, CAV2 and CPV
From 4 weeks after the primary vaccination for CPiV and CAV-1
Duration of immunity:
The duration of immunity lasts for one year after the primary vaccination for all components. For CPV and CAV-1, the duration of immunity was demonstrated by serological data. For CPV, it was shown that one year after the vaccination CPV-2 and CPV-2c antibodies are still present. In the duration of immunity studies there was no significant difference between vaccinated and control dogs in viral excretion for CPiV or CAV-2.
4.4 Special warnings for each target species
The presence of maternally derived antibodies (puppies from vaccinated females) may in some cases interfere with the vaccination. Therefore the vaccination scheme should be adapted accordingly (see section 4.9).
4.5 Special precautions for use
Special precautions for use in animals
Apply usual aseptic procedures.
Vaccinate only healthy animals.
After vaccination, the live viral vaccinal strains (CAV-2, CPV) can be spread to unvaccinated animals without any pathological effect for these in-contact animals.
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.
4.6 Adverse reactions (frequency and seriousness)
After the administration of one dose of the product, a moderate local reaction which resolves spontaneously within 1 to 2 weeks may commonly be observed. This transient local reaction can be a swelling (≤ 4 cm) or slight diffuse local oedema, in rare cases associated with pain or pruritus.
Some transient post-vaccinal lethargic states are common. In rare cases hyperthermia or digestive disturbances such as anorexia, diarrhoea or vomiting may occur.
Very rare hypersensitivity reactions have been reported, in case of such an allergic or anaphylactic reaction, appropriate symptomatic treatment should be administered.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions 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
Do not use during pregnancy and lactation.
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 Virbac’s Leptospira vaccine if available.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product 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
After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the following vaccination schedule:
Primary vaccination course:
- first injection from 8 weeks of age
- second injection 3 or 4 weeks later
When active immunisation against leptospira is also required, Virbac’s Leptospira vaccine can be used in place of the solvent. After reconstitution of one dose of the product with one dose of Virbac’s Leptospira vaccine, shake gently (the reconstituted product is slightly pinkish beige) and administer immediately one dose of 1 ml subcutaneously according to the same vaccination schedule: 2 injections 3 to 4 weeks apart from 8 weeks of age.
One booster injection of a single dose should be given 1 year after the second injection and annually thereafter.
Maternally derived antibodies may in some cases influence the immune response to vaccination. In such cases, a third injection is recommended from 15 weeks of age.
The appearance of the reconstituted product is slightly pink.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The administration of a 10 fold overdose at a single injection site did not cause any reactions other than those mentioned in Section 4.6 ‘Adverse reactions’ except that the duration of local reactions was increased (up to 26 days).
4.11 Withdrawal period(s)
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Dog - Live viral vaccines.
ATCvet code: QI07AD04
To stimulate active immunity against canine distemper virus, canine adenovirus, canine parvoviruses, canine parainfluenza virus.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Potassium dihydrogen phosphate
Water for injections
Disodium phosphate anhydrous
Water for injections
Do not mix with any other veterinary medicinal product, except those mentioned in 4.8.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf life after reconstitution according to directions: use immediately after reconstitution.
6.4 Special precautions for storage
Store and transport refrigerated (2 C – 8 C).
Protect from light.
Do not freeze.
6.5 Nature and composition of immediate packaging
Type I glass vial containing 1 dose of lyophilisate and type I glass vial containing 1 ml of solvent, both closed by a butyl-elastomer stopper and sealed with an aluminium cap, in a plastic or cardboard box.
1 vial lyophilisate and 1 vial solvent
5 vials lyophilisate and 5 vials solvent
10 vials lyophilisate and 10 vials solvent
25 vials lyophilisate and 25 vials solvent
50 vials lyophilisate and 50 vials solvent
100 vials lyophilisate and 100 vials solvent
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 product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
1ère avenue - 2065m - LID
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
08 September 2016
10. DATE OF REVISION OF THE TEXT
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