1. name of the immunological veterinary medicinal product




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02692GB – C13 October 2005

SUMMARY OF THE PRODUCT CHARACTERISTICS

1. name of the immunological veterinary medicinal product

Leucogen®




2. Qualitative and quantitative composition

The vaccine contains the purified p45 FeLV-envelope antigen, obtained by genetic recombination of the E. Coli strain. The antigenic suspension is adjuvanted with an aluminium hydroxide gel and with a purified extract of Quillaja Saponaria.


Active ingredient Formula and titre per ml

. Minimum quantity of recombinant molecule 102 µg


Adjuvants

. 3 % aluminium hydroxide gel 0.1 ml

. Purified extract of Quillaja saponaria 10 µg
Excipient q.s.f 1 ml


3. Pharmaceutical form

Suspension for injection.




4. IMMUNological properties

To stimulate active immunity to feline leucosis.




5. Clinical particulars

5.1. Target species

Cat.


5.2. Indication for use





  • For active immunisation of healthy cats to prevent persistent Feline Leukaemia virus viraemia and any associated clinical signs of the feline leucosis.

  • The onset of protection begins 2 weeks after immunisation and the duration of protection lasts one year after the primo-vaccination.

5.3. Contra-indications

Since no data have been generated, it is recommended not to vaccinate females during pregnancy and lactation.


5.4. Undesirable effects, frequency and seriousness

Transient and small thickening or nodule may be observed at the injection site and disappear within 2 to 6 weeks without treatment.

Occasionally, systemic reactions (hyperthermia, anorexia, lethargy) may occur within one or two days after vaccine administration.

5.5. Special precautions for use

The vaccine should be administered in accordance with the usual aseptic conditions for vaccination.

Vaccinate only healthy animals.

It is recommended that animals be treated for intestinal parasites at least 10 days prior to vaccination.



5.6. Use during pregnancy and lactation

Do not use in pregnant cats.



5.7. Interaction with other vaccine and medicaments when administered in combination with the product

Simultaneous administration with Feligen® RCP is possible as studies have demonstrated that the efficacy and safety remain unaffected when both products are mixed together for a single administration.


No information is available on the safety and efficacy from the concurrent use of this vaccine with other immunological products. It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with Leucogen®.

5.8. Posology and method of administration

Shake the vial before use. Administer via the subcutaneous route 1 dose of LEUCOGEN according to the following regimen of vaccination.


. Basic vaccination scheme

A first injection in cats from minimum 8 weeks of age.

A second injection of cats 3 to 4 weeks later.
. Re-vaccination scheme

Annual.


5.9. Overdose

No undesirable effects have been seen after the administration of an overdose of LEUCOGEN except those indicated in section 5.4. UNDESIRABLE EFFECTS.



5.10. Special warnings

None.


5.11. Withdrawal period

Not applicable.



5.12. Special precautions to be taken by the person administering the product to animals

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




6. Pharmaceutical particulars




6.1. Major incompatibilities

Do not mix with other vaccine/immunological product except Feligen® RCP.



6.2. Shelf life

2 years.


6.3. Special precautions for storage

Store and transport in the original package at a temperature of 4°C  2°C and away from light.

Do not freeze.

6.4. Nature and contents of container




A 3 ml-glass vial containing the adjuvanted liquid, stopped with a 13 mm-diameter stopper and set with an aluminium capsule.


Each 3 ml-glass vial is filled with 1.1 + 0.05 ml of vaccine.

6.5. Special precautions for the disposal of unused medicinal product or waste materials

Any unused product or waste material should be disposed of in accordance with national requirements.

7. NAME OR CORPORATE NAME AND ADDRESS OR REGISTERED PLACE OF BUSINESS OF THE MARKETING-AUTHORISATION HOLDER
Virbac S.A.

1ère avenue – 2065 m – L.I.D.



06516 Carros Cedex

8. FURTHER INFORMATION

Vm 05653/4049



POM

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