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Nobivac Piro - Patient leaflet, side effects, dosage

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Patient leaflet - Nobivac Piro

Name and address of the manufacturers of the biological active substance(s)

Intervet de Bilt

Ambachtstraat 2, De Bilt The Netherlands

Intervet International B.V.

Wim de Korverstraat 35, Boxmeer The Netherlands

Name and address of the manufacturer responsible for batch release

Intervet International B.V.

Wim de Korverstraat 35, Boxmeer The Netherlands

  • B. CONDITIONS OF THE MARKETING AUTHORI RESTRICTIONS REGARDING SUPPLY AND U

Veterinary medicinal product subject to medical prescripti

The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.

Not applicable

Not applicable

D. STATEMENT OF THE

C. PROHIBITION OF SALE, SUPPLY AND/OR USE


Babesia canis and


PARTICULARS TO APPEAR ON THE OUTER PACKAGE OR, WHERE THERE IS NO OUTER PACKAGE, ON THE IMMEDIATE PACKAGE

Outer box

  • 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobivac Piro

  • 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCE(S)



Per dose:

606 (301–911) total antigenic mass units of soluble parasite antigen (SPA)

Disposal: see package insert



  • 13. THE WORDS „FOR ANIMAL TREATMENT ONLY“ AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only.

Veterinary medicinal product subject to prescription.


  • 14. THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN

Keep out of reach and sight of children.


  • 15. NAME AND ADDRESS OF THE MA R KETING AUTHORISATION HOLDER

    EU/2/04/046/001–003

    Lot: {number

    17. MANUFA

    BATCH NUMBER


    Intervet International B.V. NL – 5831 AN Boxmeer

    16. MARKETING AUTH

    ION NUMBER(S)



PARTICULARS TO APPEAR ON SMALL SINGLE DOSE CONTAINERS OTHER THAN AMPOULES

MINIMUM PARTICULARS TO APPEAR ON AMPOULES

Label of the vaccine

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobivac Piro

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

Lot: {number}

5. EXPIRY DATE


Exp: {date}


6. THE WORDS "FOR ANIMAL TREATMENT ONLY

For animal treatment only.

SES


PARTICULARS TO APPEAR ON SMALL SINGLE DOSE CONTAINERS OTHER THAN AMPOULES


MINIMUM PARTICULARS TO APPEAR ON AMPOULES


Label of the adjuvant


1. NAME OF THE VETERINARY MEDICINAL PRODUCT


Adjuvated solvent for Nobivac Piro.


2. QUANTITY OF THE ACTIVE SUBSTANCE(S)


Not applicable.


3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBE


1 dose


4. ROUTE(S) OF ADMINISTRATION


Not applicable.


5. BATCH NUMBER


Lot: {number}


6. EXPIRY DATE


Exp: {date}


7. THE WORDS “FOR ANIMAL TREATMENT ONLY


For animal treatment o


PACKAGE LEAFLET



1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AN

THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BA RELEASE, IF DIFFERENT


Intervet International B.V.

Wim de Körverstraat 35 NL – 5831 AN Boxmeer


2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobivac Piro lyophilisate and solvent for suspension for injections for dogs


3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND O


NGREDIENTS


Per 1 ml dose of the reconstituted product:

606 (301–911) total antigenic mass units of soluble parasite antigen (SPA) from Babesia canis and Babesia rossi cultures

Adjuvant: 250 (225–275) ^g saponin (from the solvent)


4. INDICATION(S)



For active immunisation of dogs of 6 months of age or older against Babesia canis to reduce the


severity of clinical signs associated with acute B Packed Cell Volume (PCV).

Onset of immunity: Three weeks after the basic

Duration of immunity: 6 months after the


osis (B. canis ) and anaemia as measured by


ation course.


Do not use in pregnant or lactati

5. CONTRAINDI­CATIONS

6. ADVERSE REACT

s.


Commonly reported post-vaccination reactions are a diffuse swelling and/or hardened nodule, accompanied by pain, at the site of vaccination. In general this disappears within 4 days. In rare cases, the reactions after the second dose of vaccine may remain for 14 days. In addition, systemic signs, such as lethargy and a reduction in appetite may also commonly occur, sometimes accompanied by pyrexia and a stiff gait. These reactions should disappear within 2–3 days.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.


7. TARGET SPECIES


Do


lvent to the


  • 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 1 ml reconstituted vaccine, via subcutaneous injection.

Vaccination scheme:

Basic vaccination course: First injection from 6 months of age, second injection 3–6 weeks l Revaccination: Single dose, every six months after the last (re-) vaccination.

  • 9. ADVICE ON CORRECT ADMINISTRATION

Allow the solvent to reach room temperature (15 – 25°C). Aseptically add lyophilisate. DO NOT SHAKE , but swirl gently.

Make sure that the lyophilisate is completely dissolved before use

Withdraw the entire contents of the reconstituted vaccine into a sterile syringe and whole contents subcutaneously.

dminister the


10. WITHDRAWAL PERIOD


Not applicable.


11. SPECIAL STORAGE CONDITIONS, IF ANY

Store and transport refrigerated (2°C – 8°C). Protect from Keep out of reach and sight of children.

Do not use after the expiry date which is stated on

12. SPECIAL WARNINGS


Only healthy dogs should be vaccinated. In particular, chronic asymptomatic carriers should be identified and treated before vaccination, with substances that do not compromise immunological responsiveness.

It is recommended that vaccinati


iven at least one month before the tick season.

As active Babesia infection might interfere with the development of protective immunity it is recommended to reduce exposure to ticks during the period of vaccination.

Currently there is only evidence of the efficacy of the vaccine against challenge with B. canis. There is a possibility that vaccinated dogs facing a challenge with other babesia's may develop disease and require treatment.

Vaccination wit caused by B. ca veterinary advic



ac Piro does not prevent infection. As a consequence a milder form of disease occur. If mild babesia-like symptoms arise which last for more than 2 days ould be sought.

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.

In the absence of compatibility studies, do not mix with any other veterinary medicinal product except the solvent supplied for use with the vaccine.


In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.

  • 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterin products should be disposed of in accordance with the local requirements.

  • 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPRO 16 July 2009

    15. OTHER INFORMATION


Frequently Asked Questions

What is Nobivac Piro used for?

Nobivac Piro is a vaccine designed to protect dogs from canine parvovirus, a highly contagious virus that can cause severe illness.

How does Nobivac Piro work?

Nobivac Piro works by stimulating the dog's immune system to produce antibodies against the canine parvovirus, providing protection from future infections.

At what age should my dog receive Nobivac Piro?

Puppies should receive their first dose of Nobivac Piro at around 6 to 8 weeks of age, followed by booster vaccinations as recommended by your veterinarian.

Is Nobivac Piro safe for all breeds of dogs?

Yes, Nobivac Piro is considered safe for all breeds of dogs. However, always consult with your veterinarian prior to vaccination.

Can puppies receive Nobivac Piro if they are not fully weaned?

It is generally recommended that puppies be fully weaned and healthy before receiving their first vaccination, including Nobivac Piro.

What are the possible side effects of Nobivac Piro?

Some dogs may experience mild side effects such as soreness at the injection site, low-grade fever, or lethargy after receiving Nobivac Piro.

How often does my dog need to be vaccinated with Nobivac Piro?

Initially, puppies require a series of vaccinations, typically at 6-8 weeks, 10-12 weeks, and a booster at around 16 weeks. After that, adult dogs will need periodic boosters as advised by your veterinarian.

Is there a specific time frame for administering Nobivac Piro before dog shows or competitions?

It's recommended to administer Nobivac Piro at least two weeks before any dog shows or competitions to ensure optimal immunity.

Can I give my dog other vaccines on the same day as Nobivac Piro?

In most cases, it is safe to administer other vaccines on the same day as Nobivac Piro. However, always consult your veterinarian for personalized advice.

What should I do if my dog has an allergic reaction after the vaccination?

If you notice symptoms such as swelling, difficulty breathing, or excessive vomiting after vaccination with Nobivac Piro, contact your veterinarian immediately.

Do indoor dogs need to be vaccinated with Nobivac Piro?

Yes, even indoor dogs can be at risk of contracting canine parvovirus. Vaccination with Nobivac Piro is essential regardless of a dog's living situation.

Can older dogs still receive Nobivac Piro vaccinations?

Yes, older dogs can receive Nobivac Piro vaccinations if they have not been previously vaccinated or if they require a booster. Consult your veterinarian for specific recommendations.

How much does a Nobivac Piro vaccination typically cost?

The cost of a Nobivac Piro vaccination can vary based on location and veterinary fees but generally ranges from $15 to $50 per dose.

Is there an alternative to vaccination with Nobivac Piro?

Vaccination is the most effective method to protect against canine parvovirus. There are no approved alternatives that provide similar immunity.

Can my dog still get canine parvovirus after being vaccinated with Nobivac Piro?

While no vaccine offers 100% protection, vaccination with Nobivac Piro significantly reduces the risk and severity of illness caused by canine parvovirus.

What should I do before taking my puppy for their first Nobivac Piro vaccination?

Ensure your puppy is healthy and has received appropriate deworming treatments prior to vaccination. Consult your veterinarian for any specific preparations needed.

How is Nobivac Piro administered by my veterinarian?

Nobivac Piro is typically administered via injection under the skin in either the shoulder area or thigh of your dog.

Are there any special precautions I should take after my dog receives Nobivac Piro?

After vaccination, monitor your dog for any adverse reactions and avoid strenuous activity for at least 24 hours. Ensure they have access to water and comfort.

Where can I find more information about updates on Noblevac vaccines like Nobivac Piro?

For updates on vaccines like Nobivac Piro, check reputable veterinary resources or speak directly with your veterinarian for the latest information and guidance.