Nobivac Piro - summary of medicine characteristics

Per 1 ml dose:

nis and

Active substance:

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

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

For a full list of excipients, see section 6.1.

Lyophilisate and solvent for suspension for injection

4.

4.1

Dogs

4.2

Target species

Indications for use, specifying the targe

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 Babesiosis (B. canis ) and anaemia as measured by Packed Cell Volume (PCV).

Onset of immunity : Three weeks

asic vaccination course.

Duration of immunity : 6 months after the last (re-)vaccination.

4.3 Contra-indications

See section 4.7.

Only healthy identified respons

As acti

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 with Nobivac Piro does not prevent infection. As a consequence a milder form of di caused by B. canis can occur. If mild babesia-like symptoms arise, which last for more than 2 da veterinary advice should be sought.

4.5 Special precautions for use

Special precautions for use in animals

Ensure that the lyophilisate is completely reconstituted before use.

Special precautions to be taken by the person administering the veterin animals

In case of accidental self-injection, seek medical advice immediately the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Commonly reported post-vaccination reactions are a diffuse accompanied by pain, at the site of vaccination. In general the reactions after the second dose of vaccine may remain

icinal product to

the package insert or

lling and/or hardened nodule,

isappears within 4 days. In rare cases, r 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.

4.7 Use during pregnancy and lactation

Do not use in pregnant or lactating bitches.

4.8 Interactions with other medicinal products and other forms of interaction

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 medicinal product therefore needs to be made on a case by case basis.

4.9 Amounts to be administered and administration route

Vaccination scheme:

Basic vaccination course: First injection from 6 months of age, second injection 3 to 6 weeks later.

Revaccination: Single dose, every 6 months after the last (re-)vaccination.

Allow the solvent to reach room temperature (15 – 25°C). Aseptically add the solvent to the

lyophilisate. Allow the lyophilisate to dissolve completely. DO NOT SHAKE, but swirl gently. Withdraw the entire contents of the reconstituted vaccine into a sterile syringe and administer the

whole contents subcutaneously.

4.10 O

symptoms, emergency procedures, antidotes), if necessary

No adverse reactions other than those mentioned in section 4.6. were observed after the administration of an overdose of vaccine.

Withdrawal period

t applicable.

Not all pack sizes may

ted.