Nobivac® Puppy DP PLUS

Nobivac® Puppy DP PLUS—The first vaccine capable of
breaking through any level of parvovirus maternally
derived antibodies (MDA) from four weeks of age.

FOR ANIMAL USE ONLY

Nobivac® Puppy DP PLUS

Reg. No. G4528 (Act 36/1947)

Lyophilisate and solvent for suspension for injection for puppies.

Only for use by or under the supervision of persons registered in terms of, or authorised in terms of, section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).

INDICATIONS

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 canine parvovirus infection.

IMMUNITY

Onset of immunity:                                 7 days for canine distemper virus.

3 days for canine parvovirus.

Duration of immunity:                            8 weeks.

This vaccine stimulates active immunity in puppies against canine parvovirus infection 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 puppies of 4 weeks of age, with low to moderate levels of maternal antibodies.

COMPOSITION

Nobivac® Puppy DP PLUS is a combination of live, attenuated strains of canine distemper virus and canine parvovirus.Each vial contains a single dose for reconstitution.

Each dose (1 mℓ) of reconstituted vaccine contains:

Live canine distemper virus strain Onderstepoort                  105,1 – 106,5 TCID50

Live canine parvovirus strain 630a                                               105,1 – 106,7 TCID50

STORAGE INSTRUCTIONS

  • Store in a refrigerator between 2 °C and 8 °C.
  • Do not freeze.
  • Protect from light.
  • Avoid prolonged or repetitive exposure to high ambient temperatures.
  • Allow the vaccine to gradually reach room temperature (between 20 °C and 25 °C) prior to use.
  • The diluent may be stored at room temperature (between 20 ºC and 25 ºC).
  • Do not freeze the diluent.

WARNINGS

  • Vaccinate healthy puppies only.
  • An adequate clinical examination should be done prior to vaccination.
  • Do NOT mix Nobivac® Puppy DP PLUS with any other vaccine or immunological product, except those specifically mentioned under INTERACTION WITH OTHER MEDICINAL PRODUCTS. No information is available on the compatibility of this vaccine with any other vaccine or medication.
  • Do not over- or under-dose the vaccine.
  • Do not inject intravenously.
  • Moderate to high levels of maternally derived antibodies against canine distemper virus, can reduce the efficacy of Nobivac® Puppy DP PLUS against canine distemper.
  • Do not open and reconstitute the vaccine until ready to start the vaccination.
  • The vaccine should be reconstituted using the supplied diluent (Nobivac® Diluent) immediately prior to use.
  • As with all vaccines, anaphylactic or hypersensitivity reactions may occur.
  • Accidental self-injection may lead to severe allergic reactions.
  • In case of accidental self-injection, seek medical advice immediately and show the package leaflet to the physician.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

  • Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.
  • Do not eat, drink or smoke whilst handling the product.
  • Use entire contents when vial is first opened and do not store partially used vials for future use.
  • Hypersensitivity reactions following administration are rare, but as with all vaccines, it may occasionally be encountered. In this event, administration of adrenaline injection by the subcutaneous route may be indicated.
  • Destroy any unused vaccine and dispose of all the vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • Do not contaminate rivers, dams or any water sources with containers or waste.

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, but without causing clinical signs of disease. Canine distemper virus is not spread by vaccinated puppies.

ADVERSE REACTIONS

  • A small, non-painful swelling (maximum 1 cm in diameter) at the injection site, is very commonly observed within the first week after vaccination. The swelling will resolve completely within a few days.
  • During, or immediately after vaccination, whining and/or scratching at the injection site, by the pet, is very commonly observed.
  • In very rare cases, Nobivac® Puppy DP PLUS may cause a hypersensitivity reaction, including anaphylaxis (sometimes fatal). In case of anaphylaxis, appropriate treatment should be administered without delay.

The occurrence 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).

INTERACTION WITH OTHER MEDICINAL PRODUCTS

Safety and efficacy data are available which demonstrate that Nobivac® Puppy DP PLUS can be administered on the same day, but not mixed with vaccines of the Nobivac® series containing Bordetella bronchiseptica and canine parainfluenza virus components for intranasal administration. Efficacy after concurrent use has not been tested.

DOSAGE AND DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Reconstitute a single dose vial (1 mℓ) and administer by subcutaneous injection in the neck or chest region.

Administer 1 dose (1 mℓ) of Nobivac® Puppy DP PLUS to puppies from 4 weeks of age onwards.

Administer the total contents of the vial. Ensure that the freeze-dried plug is completely reconstituted before use. The reconstituted product is an off-pink or pink coloured suspension.

PRESENTATION

Lyophilisate: off-white or cream-coloured freeze-dried pellet in a Type I clear glass vial, closed with a chlorobutyl rubber stopper and aluminium cap. Each vial contains 1 dose.

Solvent (1 mℓ): clear, colourless solution in a Type I clear glass vial of 1 mℓ, closed with a bromobutyl rubber stopper and aluminium cap.

Plastic tray with 5 x 1 dose vials of vaccine and 5 vials containing 1 mℓ of solvent.

Plastic tray with 25 x 1 dose vials of vaccine and 25 vials containing 1 mℓ of solvent.

Not all pack sizes may necessarily be marketed.

REGISTRATION HOLDER                                                              

Intervet South Africa (Pty) Ltd.                                                   

20 Spartan Road, Spartan                                                              

1619, RSA                                                                                

Tel: +27 (0) 11 923 9300                                                    

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF PACKAGE INSERT 2 February 2023