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Date: Thursday, May 30, 2024 6:09

Description: Virbac 2013
Release 5.51
Canixin DHPPi/L (GB Only)
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Canixin DHPPi/L
Product index: Canixin DHPPi/L
Incorporating:
Qualitative and quantitative composition
Each dose of 1ml contains:
Active substances
Lyophilisate
Live attenuated canine distemper virus (CDV) - Lederle strain 103.0 - 104.9 CCID50*
Live attenuated canine adenovirus type 2 (CAV-2) - Manhattan strain 104.0 - 106.0 CCID50*
Live attenuated canine parvovirus (CPV) - CPV780916 strain 105.0 - 106.8 CCID50*
Live attenuated canine parainfluenza virus (CPIV) - Manhattan strain105.0- 106.9 CCID50*
*Cell culture infectious dose 50%
Suspension
Inactivated Leptospira interrogans:
serogroup Canicola serovar Canicola, strain 601903 4350 - 7330 U**
serogroup Icterohaemorrhagiae serovar Icterohaemorhagiae, strain 601895 4250 - 690 U**
**Antigenic mass ELISA units
Pharmaceutical form
Lyophilisate and suspension for suspension for injection.
Lyophilisate: White lyophilisate
Suspension: Translucent liquid
Clinical particulars
Target species
Dog
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;
- prevent mortality and reduce infection, clinical signs, kidney colonisation, renal lesions and urine shedding of L. canicola;
- reduce infection, clinical signs, kidney colonisation and urine shedding of L. icterohaemorrhagiae;
Onset of immunity
The onset of immunity has been demonstrated from 3 weeks after the primary vaccination for CDV, CAV-2 and CPV, 4 weeks for CAV-1 and CPiV, 5 weeks for L. Canicola and 2 weeks for L. Icterohaemorrhagiae.
Duration of immunity
After the primary vaccination course, the duration of immunity lasts for one year for all components.
In the duration of immunity studies one year after the basic vaccination scheme there was no significant difference between vaccinated and control dogs in viral excretion for CPiV and CAV-2, in reduction of kidney colonisation for L. Canicola and L. Icterohaemorrhagiae, nor in renal lesions and urine shedding for L. Canicola.
After the annual booster, the duration of immunity lasts for 3 years for CDV, CAV-1, CAV-2 and CPV.
For CAV-2, the duration of immunity after the annual booster was not established by challenge, and is based on the presence of CAV-2 antibodies 3 years after the booster vaccination.
Contra-indications
None
Special warnings for each target species
Vaccinate healthy animals only.
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 below).
Special precautions for use
Special precautions for use in 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.
Adverse reactions (frequency and seriousness)
A transient swelling (≤ 4 cm) or slight diffuse local oedema in rare cases associated with pain or pruritus was commonly observed in safety studies. Any such local reaction resolves spontaneously within 1 to 2 weeks.
Some transient post-vaccinal lethargic states were commonly observed in clinical studies.
Transient hyperthermia or digestive disturbances such as anorexia, diarrhoea or vomiting were rarely observed from spontaneous reports.
Hypersensitivity reactions (e.g. anaphylaxis, skin manifestations such as oedema/swelling, erythema, pruritus) have been reported in very rare cases from spontaneous reports. In case of such an allergic or anaphylactic reaction, appropriate symptomatic treatment should be administered.
Use during pregnancy, lactation or lay
Do not use during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
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.
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.
Re-vaccinations
One booster injection of a single dose should be given one year after the primary vaccination course.
Subsequent vaccinations are carried out at intervals of up to three years.
Annual revaccination is required for CPiV and Leptospira components, therefore a single dose of the Virbac vaccine against Canine Parainfluenza virus and Leptospira can be used annually.
The appearance of the reconstituted product is slightly pinkish beige.
Overdose
The administration of a 10 fold overdose at a single injection site did not cause any reactions other than those mentioned above except for the duration of the local reactions (up to 26 days).
Withdrawal period(s)
Not applicable
Pharmacological particulars
Immunological properties
To stimulate active immunity against canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus and L. interrogans serogroup Canicola and L. interrogans serogroup Icterohaemorrhagiae
Pharmaceutical particulars
Excipients
Lyophilisate : Gelatin, Potassium hydroxide, Lactose monohydrate, Glutamic acid, Potassium dihydrogen phosphate, Dipotassium phosphate, Water for injections, Sodium chloride, Disodium phosphate
Suspension : Sodium hydroxide (for pH adjustment), Sucrose, Dipotassium phosphate, Potassium dihydrogen phosphate, Tryptone, Water for injections
Major incompatibilities
Do no mix the vaccine with any other veterinary medicinal product.
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.
Special precautions for storage
Store and transport refrigerated (2°C – 8°C). Protect from light. Do not freeze
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.
Marketing Authorisation Holder (if different from distributor)
Virbac
Premiere Avenue
2065M - L I D
F-06516 Carros Cedex
France
Marketing Authorisation Number
Vm 05653/5054
Significant changes
Date of the first authorisation or date of renewal
14 May 2012
Date of revision of the text
17 February 2021
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Canixin DHPPi/L (50 Dose)
GTIN:3597133062304