Nobivac Dp Plus + Solvent 5 x 1 dose

Target species
Dogs (puppies).
Indications for use
For the active immunisation of puppies from 4 weeks of age onwards to prevent clinical signs and mortality of canine distemper virus infection and canine parvovirus infection and to prevent viral excretion following canine distemper virus infection and following canine parvovirus infection.
Onset of immunity: for canine distemper virus: 7 days;
for canine parvovirus: 3 days.
Duration of immunity: 8 weeks.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Moderate to high levels of maternally derived antibodies against canine distemper virus can reduce the efficacy of the product against canine distemper.
It is typically advised that each pup is vaccinated with this product at 6 weeks of age. In cases where there is a high risk of canine parvovirus infection and/or canine distemper virus infection, it is advised that pups are vaccinated earlier, but not before 4 weeks of age. The routine vaccinations with core vaccines against canine distemper, canine parvovirosis, canine contagious hepatitis and respiratory disease caused by adenovirus type 2 infection should be given as indicated in the package leaflets of these products.
Special precautions for use
In some puppies, the canine parvovirus vaccine strain may be found in faeces for up to 8 days after vaccination. Occasionally this virus can spread to other dogs or cats, but without causing clinical signs of disease. In cats, the virus may be shed up to 5 days and spread to other cats without causing any signs of disease. Canine distemper virus is not spread by vaccinated puppies.
Operator warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
A small, non-painful swelling (maximum 1 cm diameter) at the injection site is very commonly observed within the first week after vaccination. The swelling will resolve completely within a few days. Reduced activity can occur in rare cases within 4 hours after vaccination.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy or lactation
The safety of the veterinary medicinal product has not been established during pregnancy.
Interactions
Safety data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccine of the Nobivac series containing Bordetella bronchiseptica and canine parainfluenza virus components for intranasal administration. Efficacy after concurrent use has not been tested. Therefore, while safety of concurrent use has been demonstrated, the veterinarian should take this into account when deciding to administer the products at the same time.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the one 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.
Administer one dose (1 ml) to puppies from 4 weeks of age onwards.
Reconstitute the vial containing the lyophilisate with the supplied solvent.
Ensure that the lyophilisate is completely reconstituted before use.
Administer the total contents of the vial.
Reconstituted product: off-pink or pink coloured suspension.
Overdose
No adverse reactions other than those mentioned in section 4.6 were observed after administration of a 10-fold overdose of the vaccine.
Withdrawal periods
Not applicable.
Pharmacological particulars
ATCvet code: QI07AD03.
Pharmacotherapeutic group
Live viral vaccine for dogs, canine distemper virus and canine parvovirus
The vaccine stimulates active immunity in puppies against canine parvovirus and canine distemper virus infection. Maternally derived antibodies against canine parvovirus do not interfere with the efficacy of this product. Immunity against canine distemper virus is achieved in animals of 4 weeks of age with low to moderate levels of maternal antibodies.
Pharmaceutical particulars
Excipients
Lyophilisate:
Hydrolysed gelatine
Pancreatic digest of casein
Sorbitol
Disodium phosphate dihydrate
Solvent:
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years.
Shelf life of the solvent as packaged for sale: 4 years.
Shelf life after reconstitution according to directions: 30 minutes.
Special precautions for storage
Lyophilisate:
Store in a refrigerator (2 °C – 8 °C).
Do not transport above 30 ºC.
Do not freeze.
Protect from light.
Solvent:
No special precautions for storage.
Immediate packaging
Lyophilisate: Type I clear glass vial of 1 dose closed with a chlorobutyl rubber stopper and aluminium cap.
Solvent: Type I clear glass vial of 1 ml closed with a bromobutyl rubber stopper and aluminium cap.
Pack sizes:
Plastic box with 5 x 1 dose vial of vaccine and 5 vials containing 1 ml of solvent.
Plastic box with 25 x 1 dose vial of vaccine and 25 vials containing 1 ml of solvent.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.