Medine.co.uk

Nobivac Felv, Suspension For Injection For Cats

Revised: April 2015

AN: 01412/2014

SUMMARY OF THE PRODUCT CHARACTERISTICS


1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT


Nobivac FeLV, suspension for injection for cats


2. Qualitative and quantitative composition


Per dose of 1 ml:


Active substance

Minimum quantity of purified p45 FeLV-envelope antigen 102 µg


Adjuvants

3 % aluminium hydroxide gel expressed as mg Al 1 ml

Purified extract of Quillaja saponaria 10 µg


Excipient

Buffered isotonic solution to 1 ml


For a full list of excipients, see section 6.1


3. Pharmaceutical form


Suspension for injection.

Opalescent liquid.


4. Clinical particulars


4.1 Target species


Cat.


4.2 Indications for use, specifying the target species



4.3 Contra-indications


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


4.4 Special Warnings


None.



4.5 Special precautions for use


Special precautions for use in animals


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.


Special precautions to be taken by the person administering the veterinary medicinal 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.


4.6 Adverse reactions (frequency and seriousness)


Transient and small thickening or nodule, approximately 5 - 10 mm in size, 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.

Where Nobivac FeLV has been used to reconstitute cat vaccines in the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain) prior to inoculation, a small nodule at the site of vaccination is frequently observed. It can persist for up to 18 days post-inoculation. Occasionally, the nodule may be painful for up to 6 days after injection. A transient rise in body temperature or lameness may occur and last up to 3 days post vaccination. In some cases, a slight dullness or reduced appetite may be observed for up to 1 day post vaccination.

In the rare event of hypersensitivity reaction following vaccination, administer an antihistamine, corticosteroid or adrenaline without delay and by the most-immediate route.


4.7 Use during pregnancy, lactation or lay


Do not use in pregnant or lactating cats.


4.8 Interaction with other medicinal products and other forms of interaction


Safety and/or efficacy data are available which demonstrate that this vaccine can be mixed with cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).

Do not mix with other medicinal products except cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).


4.9 Amounts to be administered and administration route


Shake the vial before use. Administer viathe subcutaneous route 1 dose of Nobivac FeLV 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.


Nobivac FeLV can be used to reconstitute 1 dose (1 vial) of cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain) immediately prior to use by the addition of the contents of one vial (1 ml) of Nobivac FeLV.


4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary


No undesirable effects have been seen after the administration of an overdose of Nobivac FeLV except those indicated in section 4.6. Adverse reactions (frequency and seriousness)


4.11 Withdrawal period


Not applicable.


5. IMMUNOLOGICAL PROPERTIES


Pharmacotherapeutic group: inactivated viral vaccine.

ATCVet code: QI06AA01. Vaccine against feline leukaemia


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


6. PHARMACEUTICAL PARTICULARS


6.1 List of excipients


Sodium chloride

Disodium phosphate anhydrous

Potassium dihydrogen phosphate

Aluminium hydroxide

Quillaja saponaria


6.2 Incompatibilities


Do not mix with other medicinal products except cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).


6.3 Shelf life


Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: use immediately.


6.4 Special precautions for storage


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

Do not freeze.

Protect from sunlight.


6.5 Nature and composition of immediate packaging


A 3 ml-glass vial with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.

Cardboard or plastic box with 10 vials.

Cardboard or plastic box with 50 vials.

Not all pack sizes may be marketed.


6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products


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


7. MARKETING AUTHORISATION HOLDER


Virbac S.A.

1ère avenue - 2065m – L.I.D.

06516 Carros Cedex

France


8. MARKETING AUTHORISATION NUMBER

Vm05653/4059


9. DATE OF FIRST AUTHORISATION


Date:28 October 2005


10. DATE OF REVISION OF THE TEXT


Date:April 2015





Approved: 29 April 2015

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