Nobivac Piro - patient leaflet, side effects, dosage

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

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

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

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