EN - Anglická CZ - Česká SK - Slovenská PL - Polská RO - Rumunská RU - Ruská TR - Turecká UA - Ukrajinská
EN - Anglická
  • CZ - Česká
  • SK - Slovenská
  • PL - Polská
  • RO - Rumunská
  • RU - Ruská
  • TR - Turecká
  • UA - Ukrajinská

Biocan Novel R, suspension for injection for dogs

Homepage Products Veterinary products Biocan Novel R, suspension for injection for dogs

Active immunization of dogs from 12 weeks of age to prevent mortality, clinical signs and infection caused by rabies virus.

type of preparative: Vaccines
target species animals: Dog

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Statement of active substances and other ingredients

Composition per 1 ml dose:

Active substances:

Inactivated rabies virus, strain SAD Vnukovo-32                        > 2.0 IU*

Adjuvant:

Aluminium hydroxide (quantified as Al2O3)                                1.8-2.2 mg

Excipients:

Thiomersal                                                                                   0.1 mg

* International Units

The suspension for injection is pink fluid with easily shakeable sediment.

Indications

Active immunization of dogs from 12 weeks of age to prevent mortality, clinical signs and infection caused by rabies virus.

Onset of immunity:

2 weeks after a single vaccination from 12 weeks of age.

Duration of immunity:

At least three years following the basic vaccination scheme. Duration of immunity was demonstrated after one vaccination at 12 weeks of age.

Contraindications

Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.

Adverse reactions

Following subcutaneous administration in dogs, a small transient swelling (£5 cm), which can be painful, warm or reddened, may be very commonly observed at the injection site in some animals. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination.

In rare cases gastrointestinal signs such as diarrhoea and vomiting or anorexia and decreased activity are possible.

As with any vaccine rare, hypersensitivity reactions may occur. If such reaction occurs, appropriate treatment should be administered without delay.

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.

Alternatively, you can report via your national reporting system {national system details}

Target species

Dogs.

Dosage for each species, routes and methods of administration

Subcutaneous use.

Dose and route of administration:

Administer the vaccine dose (1 ml) subcutaneously.

Basic vaccination scheme:

One dose of Biocan Novel R from 12 weeks of age.

The efficacy is proven after a single dose from 12 weeks of age in laboratory studies.

However, in field studies 10% of seronegative dogs did not show seroconversion (> 0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies. Another 17% did not show the 0.5 IU/ml rabies antibody titre required by some non-EU countries to travel in. In case of travelling to risk areas or for travel outside the EU veterinary surgeons may wish to use a two dose primary course including rabies or give an additional rabies vaccination after 12 weeks.

Revaccination scheme:

A single dose of Biocan Novel R should be given every 3 years.

Although the efficacy of the rabies fraction has been demonstrated following administration at 12 weeks, in case of need, dogs younger than 12 weeks can be vaccinated. In this case the vaccine Biocan Novel R can be used to reconstitute a single dose vial of Biocan Novel DHPPi (please refer to SPC for Biocan Novel DHPPi) as the safety of this association has been demonstrated in 6-week-old dogs. The second dose of Biocan Novel R should not be administered before 12 weeks of age and not earlier than 3 weeks after the first dose.

Advice on correct administration

Shake well before use.

Withdrawal period

Not applicable.

Special storage precautions

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C–8 °C).

Do not freeze. Protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

Shelf-life after first opening the container: 10 hours

Special warning

Special warnings for each target species:

Vaccinate healthy animals only.

A good immune response is reliant on a fully competent immune system. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

Special precautions for use in animals:

Do not use in animals that are showing signs of rabies or that are suspected of being infected with rabies virus.

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 and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore, the use is not recommended during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction:

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccine Biocan Novel DHPPi.

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.

Incompatibilities:

Do not mix with any other veterinary medicinal product, except vaccine Biocan Novel DHPPi.

Special precautions for the disposal of unused product or waste materials, if any

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

Other information

The vaccine is supplied in cardboard or transparent plastic boxes containing 10, 25 or 50 vials with 1 ml (1 dose) of suspension and 1 or 10 vials with 10 ml (10 dose) of suspension

Not all pack sizes may be marketed.


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