Quantum Dog 7 Data Sheet

NAME OF THE VETERINARY MEDICINAL PRODUCT
Quantum™ Dog 7

QUALITATIVE AND QUANTITATIVE COMPOSITION

PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection.

CLINICAL PARTICULARS
Target species
Dogs

Indications for use, specifying the target species
Active immunisation of dogs to prevent mortality and clinical signs due to canine distemper virus infections, to prevent clinical signs including leucopenia and reduce viral shedding caused by canine parvovirus  (type 2a) to prevent mortality and clinical signs including leucopenia and reduce viral shedding caused by canine parvovirus (types 2b and 2c), to reduce mortality and clinical signs due to canine adenovirus type 1 infections, to reduce clinical signs and infection or excretion due to canine adenovirus type 2 infections, to reduce clinical signs and infection due to Leptospira canicola and icterohaemorrhagiae and, to reduce pathological signs of disease caused by canine parainfluenza virus infections.
Onset of immunity occurs by approximately two weeks after the last dose of the Basic Vaccination Scheme. 
Onset of immunity for the canine parvovirus component (type 2b) occurs 7 days after a single dose when animals are vaccinated from 9 weeks of age.

The duration of immunity for canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2 and the leptospiral components is at least 12 months. However, the duration of immunity for canine parainfluenzavirus has not been determined.

Contra-indications
Do not use in unhealthy animals.

Special warnings for each target species
The canine adenovirus Type 2 and canine parvovirus vaccinal strains may be shed from vaccinated animals for a number of days following vaccination.  However, due to the low pathogenicity of these strains, it is not necessary to keep vaccinated animals separated from non-vaccinated animals.

High levels of maternally derived antibodies (MDA) may interfere with the response to vaccination. Although the vaccine has been shown to be efficacious in the presence of levels of MDA that are likely to be encountered under field conditions, where for any reason it is likely that particularly high levels of MDA are present (for example against the CPV component), this should be taken into account when planning the timing of vaccinations.

Special precautions for use, including special precautions to be taken by the person administering the medicinal product to animals
i) Special precautions for use in animals
None.

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical attention showing a copy of the product literature.

Adverse Reactions (frequency and seriousness)
Vaccinated dogs may have a transient swelling 4-6 hours after vaccination which resolves after approximately 7 days. 
If a systemic anaphylactic reaction occurs (eg vomiting), administer adrenaline or an equivalent.

Use during pregnancy, lactation and lay
Do not use during pregnancy.

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 made on a case by case basis.

Amounts to be administered and administration route
Dosage and route of administration:
Reconstitute one vial of the freeze-dried fraction (Quantum Dog DA2Pi) aseptically using the contents of one vial of the liquid fraction (Quantum Dog CPV-L) as diluent.  Shake well and immediately inject the entire contents of the reconstituted vial (1 ml) subcutaneously. Do not use chemically sterilised syringes or needles, as these will interfere with the effectiveness of the vaccine.

Basic Vaccination Scheme:
Puppies younger than 10 weeks of age

Two doses of Quantum Dog 7 at least 14 days apart.  The first dose can be given as young as 7 weeks of age.  The second dose should not be given until at least 10 weeks of age.

Puppies 10 weeks of age and older
A single dose of Quantum Dog 7, followed by a single dose of Quantum Dog CPV-L (or alternatively a second dose of Quantum Dog 7) at least 14 days later.

Re-vaccination Scheme:
A single dose of Quantum Dog 7 to be given annually thereafter.

Overdose (symptoms, emergency procedures, antidotes), if necessary
Occasional transient swellings may occur at the injection site after vaccination with an overdose.
No treatment is necessary in most cases of overdose. However, if a systemic anaphylactic reaction occurs (eg vomiting), administer adrenaline or an equivalent.

Withdrawal period
Not applicable.

IMMUNOLOGICAL PROPERTIES
ATCvet code: QI07AI02
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine adenoviruses Types 1 and 2, canine parainfluenzavirus, canine parvovirus, Leptospira canicola and Leptospira icterohaemorrhagiae.

PHARMACEUTICAL PARTICULARS
List of Excipients
Traces of neomycin and gentamycin.

Incompatibilities
Do not mix with any other veterinary medicinal product.

Shelf life
Shelf-life as packaged for sale:
For the freeze-dried fraction (Quantum Dog DA2Pi) – 2 years.
For the liquid fraction (Quantum Dog CPV-L) – 4 years.
The vaccine should be administered immediately after reconstitution.

Special precautions for storage
Store and transport at 2C – 8C. Do not freeze.

Nature and Composition of immediate packaging
The vaccine is filled in 1 dose vials glass Type I (Ph Eur).  Vials of the freeze-dried fraction are closed with a bromobutyl rubber stopper and a varnished aluminium cap.  Vials of the liquid fraction are closed with a chlorobutyl rubber stopper and a varnished aluminium cap.
Pack contains 1, 10, 25 or 100 vials of Quantum Dog DA2Pi freeze-dried fraction and 1, 10, 25 or 100 vials of 1 ml Quantum Dog CPV-L liquid fraction.
Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

MARKETING AUTHORISATION NUMBER
Vm 01708/4560

DATE OF RENEWAL OF AUTHORISATION
1 January 2011.

DATE OF REVISION OF THE TEXT
16 May 2011.

Further information
Nil.

Legal category
POM-V   To be supplied only on veterinary prescription.

For animal treatment only. Keep out of reach and sight of children.