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Leucogen


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Summary for the public


What is Leucogen?

Leucogen is a vaccine for cats that contains a protein of feline leukaemia virus (FeLV).

Leucogen is available as a suspension for injection.


What is Leucogen used for?

Leucogen is used to vaccinate cats from eight weeks of age against feline leukaemia (an illness affecting the immune system caused by a retrovirus). It is used to prevent the symptoms of the disease and to prevent FeLV from remaining in the blood.

Leucogen is given to kittens as two injections under the skin. The first injection is given when the kitten is about eight weeks old, and the second three/four weeks later. Afterwards, cats need a booster injection every year.


How does Leucogen work?

Leucogen is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Leucogen contains small amounts of a protein from the FeLV called ‘envelope p45 protein’. The FeLV protein used in the vaccine is not extracted from viruses but is made in a bacterium using ‘recombinant DNA technology’.

When a cat is given the vaccine, the immune system recognises the FeLV protein as ‘foreign’ and makes antibodies against it. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to FeLV. The antibodies will help to protect against the disease caused by the virus. When exposed to the virus later in life, the cat will either not become infected or have a much less serious infection.


How has Leucogen been studied?

Because Leucogen has been available in the European Union (EU) since 1988, and is also used as part of a multivalent vaccine called Leucofeligen FeLV/RCP, the company used data from studies carried out with these vaccines to support the use of Leucogen.

Two main ‘field’ studies involved kittens aged eight to nine weeks, the first using Leucogen and the second using Leucofeligen FeLV/RCP. The main measure of effectiveness was the presence of antibodies against FeLV in the vaccinated kittens’ blood. Further studies were carried out under laboratory conditions to show that vaccination prevented FeLV from remaining in the blood.


What benefit has Leucogen shown during the studies?

The studies showed that Leucogen provided protection against FeLV infection. Vaccination on two occasions with three to four weeks between injections prevented FeLV from remaining in the blood and prevented the signs of FeLV infection.


What is the risk associated with Leucogen?

A temporary small nodule (hard swelling) may appear at the site of injection. This usually resolves on its own within three to four weeks. This reaction is reduced after subsequent injections. In rare cases, there may be pain on being touched, sneezing or conjunctivitis (eye inflammation). These resolve without any treatment. The temporary usual signs following vaccination, such as increased temperature, apathy (listlessness) and digestive problems such as abdominal discomfort may also be seen following vaccination. For a full list of all side effects reported with Leucogen, see the Package Leaflet. Leucogen should not be used in pregnant cats. Its use is not recommended in cats nursing kittens.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection, seek medical advice immediately and show the Package Leaflet or the label to the doctor.


Why has Leucogen been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Leucogen exceed the risks for the active immunisation of cats from eight weeks of age against feline leukaemia, and recommended that Leucogen be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Leucogen

The European Commission granted a marketing authorisation valid throughout the EU for Leucogen to Virbac S.A. on 17 June 2009. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Leucogen
EMEA Product number: EMEA/V/C/000144
Active substance: purified p45 FeLV-envelope antigen
INN or common name: Adjuvanted vaccine against feline leukaemia
Species: Cats
ATCvet Code: QI06AA01
Marketing Authorisation Holder: Virbac S.A.
Revision: 0
Date of issue of Market Authorisation valid throughout the European Union: 17/06/2009
Contact address:
Virbac S.A.
1ère Avenue 2065 M
06516 Carros
France




Product Characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS


1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
LEUCOGEN suspension for injection for cats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml:
Minimum quantity of purified p45 FeLV-envelope antigen
102 µg
3 % aluminium hydroxide gel expressed as mg Al
1 mg
Purified extract of Quillaja saponaria
10 µg
Excipients:
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
Cats
4.2 Indications for use, specifying the target species
Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of
persistent viraemia and clinical signs of the related disease.
Onset of immunity: 3 weeks after the primary vaccination.
The duration of immunity is one year after the primary vaccination .
4.3 Contraindications
None.
4.4 Special warnings
None.
2
Active substance:
Adjuvants:
4.5 Special precautions for use
Special precautions for use in animals
- Vaccinate only healthy animals.
- De-worming at least 10 days prior to vaccination is recommended.
- Only Feline Leukaemia Virus (FeLV) negative cats should be vaccinated. Therefore, a test for
presence of FeLV before vaccination is recommended.
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.
4.6 Adverse reactions (frequency and seriousness)
After the first injection, a moderate and transient local reaction ( < 2 cm) can occur (oedema, swelling,
nodule). This reaction resolves spontaneously within 3 to 4 weeks at the most. After the second
injection, and subsequent administrations, this reaction is markedly reduced. In rare cases, pain at
palpation, sneezing or conjunctivitis may be noted, that resolves without any treatment. The transient
usual signs following vaccination may also be observed, such as: hyperthermia (lasting 1 to 4 days),
apathy, digestive disturbances.
In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
4.7 Use during pregnancy, lactation or lay
Do not use in pregnant cats.
Use is not recommended during lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with
FELIGEN CRP or FELIGEN RCP.
4.9 Amounts to be administered and administration route
Subcutaneous use.
Shake gently the vial and administer subcutaneously one dose of the veterinary medicinal product
according to the following regimen of vaccination.
Primary vaccination:
- first injection in kittens from eight weeks of age
- second injection 3 or 4 weeks later.
Maternally derived antibodies can negatively influence the immune response to vaccination. In such
cases where maternally derived antibodies are expected, a third injection may be appropriate from 15
weeks of age.
Revaccination:
Annual
3
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions were observed after an overdose administration (2 doses) of the veterinary
medicinal product other than those mentioned in section 4.6 except local reactions that can last longer
(5 to 6 weeks at the most).
4.11 Withdrawalperiod
Not applicable.
5.
IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated viral vaccine
ATCvetcode: QI06AA01
Vaccine against feline leukaemia.
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.
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 any other vaccine or immunological product except FELIGEN RCP or FELIGEN
CRP.
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. Specialprecautionsforstorage
Store and transport refrigerated (2
°
C – 8
°
C)
Do not freeze
Protect from light
4
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.
Box of 10 vials
Box of 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 veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Virbac
1ère avenue – 2065 m – L.I.D.
06516 Carros Cedex
France
8.
MARKETING AUTHORISATION NUMBER(S)
EU/2/09/096/001
EU/2/09/096/002
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/06/2009
10 DATE OF REVISION OF THE TEXT
17/06/2009
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMEA) http://www.emea.europa.eu /.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
5
ANNEX II
A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
6
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) of the biological active substance(s)
PP MANUFACTURING CORPORATION
175 crossing Boulevard, Suite 200, Framingham, Massachusetts 01702, USA
Name and address of the manufacturer(s) responsible for batch release
Virbac
1ère avenue – 2065 m – L.I.D., 06516 Carros Cedex France
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
7
ANNEX III
LABELLING AND PACKAGE LEAFLET
8
A. LABELLING
9
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Box of 10 vials
Box of 50 vials
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
LEUCOGEN suspension for injection for cats.
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per dose of 1 ml:
Active substance:
Minimum quantity of purified p45 FeLV-envelope antigen: 102 µg
Adjuvants:
3 % aluminium hydroxide gel, Purified extract of Quillaja saponaria
Excipients:
Buffered isotonic solution
3.
PHARMACEUTICAL FORM
Suspension for injection .
4.
PACKAGE SIZE
Box of 10 vials
Box of 50 vials.
5.
TARGET SPECIES
Cats
6.
INDICATION(S)
Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of
persistent viraemia and clinical signs of the related disease.
Onset of immunity: 3 weeks after the primary vaccination.
The duration of immunity is one year after the primary vaccination .
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use
10
 
8.
WITHDRAWAL PERIOD
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use
10. EXPIRY DATE
EXP {month/year}
Once broached the product should be used immediately.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2
°
C – 8
°
C)
Do not freeze
Protect from light
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: read the package leaflet
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Virbac, 1ère avenue – 2065 m – L.I.D., 06516 Carros Cedex France
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/09/096/001
EU/2/09/096/002
11
 
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
12
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Vial label
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
LEUCOGEN suspension for injection for cats
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Minimum quantity of purified p45 FeLV-envelope antigen, 102 µg
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 dose of 1 ml
4.
ROUTE(S) OF ADMINISTRATION
Subcutaneous use
5.
WITHDRAWAL PERIOD
Not applicable
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}>
Once broached the product should be used immediately.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
13
 
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET FOR:
LEUCOGEN Suspension for injection for cats
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer for the batch release:
Virbac, 1 ère avenue – 2065 m – L.I.D., 06516 Carros Cedex France
2.
NAME OF VETERINARY THE MEDICINAL PRODUCT
LEUCOGEN suspension for injection for cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
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 mg
Purified extract of Quillaja saponaria : 10 µg
Excipients:
Buffered isotonic solution to 1 ml
Opalescent liquid.
4.
INDICATION(S)
Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of
persistent viraemia and clinical signs of the related disease.
Onset of immunity: 3 weeks after the primary vaccination.
The duration of immunity is one year after the primary vaccination .
5.
CONTRAINDICATIONS
None
6.
ADVERSE REACTIONS
After the first injection, a moderate and transient local reaction ( < 2 cm) can occur (oedema, swelling,
nodule). This reaction resolves spontaneously within 3 to 4 weeks at the most. After the second
injection, and subsequent administrations, this reaction is markedly reduced. In rare cases, pain at
palpation, sneezing or conjunctivitis (eye inflammation) may be noted, that resolves without any
treatment. The transient usual signs following vaccination may also be observed: hyperthermia
(lasting1 to 4 days), apathy (listlessness), digestive disturbances (abdominal discomfort).
In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
15
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Cats
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use (under the skin).
Administer subcutaneously (under the skin) one dose of the veterinary medicinal product according to
the following regimen of vaccination.
Primary vaccination:
- first injection in kittens from eight weeks of age
- second injection 3 or 4 weeks later.
Maternally derived antibodies can negatively influence the immune response to vaccination. In such
cases where maternally derived antibodies are expected, a third injection may be appropriate from 15
weeks of age.
Revaccination: Annual
9.
ADVICE ON CORRECT ADMINISTRATION
Shake gently the vial before use.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store and transport refrigerated (2
°
C – 8
°
C).
Do not freeze.
Protect from light.
Do not use after the expiry date stated on the label after EXP{ month/year }
Once broached, the product should be use immediately.
12. SPECIAL WARNING(S)
Interactions with other medicinal products
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with FELIGEN
CRP and FELIGEN RCP.
16
Overdose
No adverse reactions were observed after an overdose administration of the veterinary medicinal
product other than those mentioned in section 6, except local reactions that can last longer (5 to 6
weeks at the most
Special precautions for use in animals
Vaccinate only healthy animals.
De-worming at least 10 days prior to vaccination is recommended.
Only FeLV negative cats should be vaccinated. Therefore, a test for presence of FeLV before
vaccination is recommended.
In case of anaphylactic shock, appropriate symptomatic treatment should be administered
Special precautions for the person administering the product
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
Use during pregnancy, lactation or lay
Do not use in pregnant cats. Use is not recommended during lactation
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon
how to dispose of medicines no longer required. These measures should help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
17/06/2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu
15. OTHER INFORMATION
Immediate packaging:
A 3 ml-glass vial with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Box of 10 vials
Box of 50 vials
Not all pack sizes may be marketed
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 WAVRE
Tel: 32 (0) 10 47 06 35
Luxembourg/Luxemburg
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 WAVRE
Tel: 32 (0) 10 47 06 35
17
Република България
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Magyarország
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Česká republika
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Malta
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Danmark
VIRBAC Danmark A/S
Profilvej 1
6000 Kolding
Tel: 45 2219 1733
Nederland
VIRBAC NEDERLAND BV
Hermesweg 15
NL-3771 ND-Barneveld
Tel: 31 (0) 342 427 100
Eesti
OÜ ZOOVETVARU
Pärnasalu 31
ET -76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
Österreich
VIRBAC Österreich GmbH
Hildebrandgasse 27
A-1180 Wien
Tel: 43 (0) 1 21 834 260
Ελλάδα
VIRBAC HELLAS A.E.
23 rd Klm National Road Athens-Lamia
145 65 Agios Stefanos
Athens - GREECE
Tel: +30 210 6219520
E-mail: info@virbac.gr
Polska
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
España
VIRBAC ESPAÑA S.A.
ES-8950 Esplugues de Llobregat (Barcelona).
Tél. : + 34 93 470 79 40
Portugal
VIRBAC DE Portugal
LABORATÓRIOS LDA
P-2080 Almeirim
Tel: (351) 243 570 500
France
VIRBAC
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
E-mail: dar@virbac.fr
România
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ireland
C&M Veterinary Distributors Limited
IE-Limerick
Tel: 353 61 314 933
Slovenija
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
18
Deutschland
VIRBAC Tierarzneimittel GmbH
West Rögen 20
D-23843 Bad Oldesloe
Tel: 49 (4531) 805 555
Norge
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ísland
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Slovenská republika
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Italia
VIRBAC SRL
Via dei Gracchi 30
I-20146 Milano
Tel: 39 02 48 53 541
Suomi/Finland
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Κύπρος
GEO. PAVLIDES & ARAOUZOS LTD
25-27 Dimostheni Severi, 1080
CY-1080 Nicosia - CYPRUS
Τηλ: + 357 22456117
E-mail: theodosiou.vet@gpa.com.cy
Sverige
VIRBAC S.A.
1 ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Latvija
OÜ ZOOVETVARU
Pärnasalu 31
ET - 76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
United Kingdom
VIRBAC Ltd
UK-Suffolk IP30 9 UP
Tel: 44 (0) 1359 243243
Lietuva
OÜ ZOOVETVARU
Pärnasalu 31
ET - 76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
19


Source: European Medicines Agency



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