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Nobivac DP Plus - Patient leaflet, side effects, dosage

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Patient leaflet - Nobivac DP Plus

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Nobivac DP PLUS lyophilisate and solvent for suspension for injection for dogs (puppies)

  • 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

  • 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobivac DP PLUS lyophilisate and solvent for suspension for injection for dogs (puppies)

  • 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.

  • 5. CONTRAINDI­CATIONS

None.

  • 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:

  • – 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).

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.

  • 7. TARGET SPECIES

Dogs (puppies)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 15. OTHER INFORMATION

Pack sizes :

  • – Plastic box with 5 × 1 dose vial of vaccine and 5 vials containing 1 ml of solvent.

  • – Plastic box with 25 × 1 dose vial of vaccine and 25 vials containing 1 ml of solvent.

Frequently Asked Questions

What is Nobivac DP Plus used for?

Nobivac DP Plus is a vaccine used to protect dogs against canine parvovirus and canine distemper virus. It helps in preventing these serious diseases.

How is Nobivac DP Plus administered?

The vaccine is usually given as an injection by a veterinarian. It may require more than one dose for full immunity.

Can puppies receive Nobivac DP Plus?

Yes, puppies can receive this vaccine. It's typically given starting at 6 to 8 weeks of age.

What are the side effects of Nobivac DP Plus?

Most dogs experience no side effects, but some may have mild reactions such as soreness at the injection site or slight fever.

How often do dogs need to be vaccinated with Nobivac DP Plus?

After the initial vaccination series, your veterinarian will recommend booster shots based on your dog's lifestyle and risk factors.

Is Nobivac DP Plus safe for pregnant dogs?

Consult your veterinarian before vaccinating pregnant dogs, as they will provide the best advice based on individual health.

Can I give my dog Nobivac DP Plus if it's sick?

It's generally recommended to wait until your dog has fully recovered from illness before vaccination. Always check with your vet.

What should I do if my dog has an allergic reaction after receiving Nobivac DP Plus?

If you notice any signs of an allergic reaction, such as swelling or difficulty breathing, seek veterinary attention immediately.

How do I know if my dog needs to be vaccinated with Nobivac DP Plus?

Your veterinarian will assess your dog's health and lifestyle to determine if Nobivac DP Plus is necessary.

Can Nobivac DP Plus be given alongside other vaccines?

Yes, many vaccines can be administered together during the same visit. However, always discuss this with your vet.

How long does immunity last after receiving Nobivac DP Plus?

Immunity duration can vary, but generally it provides protection for at least one year; consult your vet for specific advice.

What is the cost of Nobivac DP Plus vaccination?

The cost can vary based on your location and veterinary clinic. It's best to contact your vet for specific pricing.

Is there an alternative to Nobivac DP Plus for dog vaccination?

There are other vaccines available; however, Nobivac DP Plus is specifically formulated for distemper and parvovirus prevention.

Where can I get my dog vaccinated with Nobivac DP Plus?

You can obtain this vaccine from licensed veterinarians or veterinary clinics that offer vaccinations.

What are the benefits of vaccinating my dog with Nobivac DP Plus?

Vaccination helps prevent serious diseases such as parvovirus and distemper, which can be life-threatening for dogs.

Can adult dogs receive their first dose of Nobivac DP Plus?

Yes, adult dogs can be vaccinated if they have never received it before; consult your vet for a tailored vaccination schedule.

What should I do after my dog receives the vaccine?

Monitor your dog for any adverse reactions and contact your veterinarian if you notice anything unusual after vaccination.

How effective is Nobivac DP Plus in preventing disease?

Nobivac DP Plus is highly effective when administered according to veterinary recommendations in preventing canine distemper and parvovirus.

Do I need to bring my dog's medical history when getting vaccinated with Nobivac DP Plus?

Yes, bringing your dog's medical history helps the veterinarian make informed decisions regarding vaccinations.

What age is recommended for a dog's first dose of Nobivac DP Plus?

The first dose is typically recommended at 6-8 weeks of age, but check with your vet for personalized advice.