Patient leaflet - Nobivac DP Plus
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Nobivac DP PLUS lyophilisate and solvent for suspension for injection for dogs (puppies)
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac DP PLUS lyophilisate and solvent for suspension for injection for dogs (puppies)
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (1 ml) of reconstituted vaccine contains:
Live attenuated canine distemper virus strain Onderstepoort: 105.1 – 106.5 TCID50*
Live recombinant canine parvovirus strain 630a: 105.1 – 106.7 TCID50
Tissue culture infective dose 50%
Lyophilisate: off-white or cream-colour.
Solvent: clear colourless solution.
4.
INDICATION(S)
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.
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5. CONTRAINDICATIONS
None.
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6. 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:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dogs (puppies)
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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.
Administer the total contents of the vial.
Reconstituted product: off-pink or pink coloured suspension.
9.
ADVICE ON CORRECT ADMINISTRATION
Ensure that the lyophilisate is completely reconstituted before use.
10.
WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
| Lyophilisate: | Store in a refrigerator (2 °C – 8 °C). Do not transport above 30 °C. Do not freeze. Protect from light. |
| Solvent: | This veterinary medicinal product does not require any special temperature storage conditions. |
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Shelf life after reconstitution according to directions: 30 minutes.
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12. SPECIAL WARNING(S)
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 animals
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.
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.
Pregnancy :
The safety of the veterinary medicinal product has not been established during pregnancy.
Interaction with other medicinal products and other forms of interaction:
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 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. 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.
Overdose (symptoms, emergency procedures, antidotes) :
No adverse reactions other than those mentioned in section “Adverse Reactions” were observed after administration of a 10-fold overdose of the vaccine.
Incompatibilities :
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION
Pack sizes :
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– Plastic box with 5 × 1 dose vial of vaccine and 5 vials containing 1 ml of solvent.
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– Plastic box with 25 × 1 dose vial of vaccine and 25 vials containing 1 ml of solvent.