Leucogen (purified p45 FeLV-envelope antigen) – Package leaflet - QI06AA01

Updated on site: 21-Sep-2017

Medication name: Leucogen
ATC: QI06AA01
Substance: purified p45 FeLV-envelope antigen
Manufacturer: Virbac S.A.

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 responsible for the batch release:

Virbac,

1ère avenue – 2065 m – L.I.D.,

06516 Carros Cedex France

2.NAME OF THE VETERINARY 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:

µg

Adjuvants:

 

 

3% aluminium hydroxide gel expressed as mg Al3+:

1 mg

Purified extract of Quillaja saponaria:

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) is commonly observed. This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 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 common signs following vaccination may

also be observed: hyperthermia (lasting1 to 4 days), apathy (listlessness), digestive disturbances (abdominal discomfort).

In very rare cases, anaphylactic reactions have been reported. In case of anaphylactic shock, appropriate symptomatic treatment should be administered.

The frequency of adverse reactions is defined using the following convention:

-very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

-common (more than 1 but less than 10 animals in 100 animals)

-uncommon (more than 1 but less than 10 animals in 1,000 animals)

-rare (more than 1 but less than 10 animals in 10,000 animals)

-very rare (less than 1 animal in 10,000 animals, including isolated reports).

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 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: annually.

9.ADVICE ON CORRECT ADMINISTRATION

Shake gently the vial before use.

10.WITHDRAWAL PERIOD

Not applicable.

11.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 stated on the label after EXP.

Shelf life after first opening the container: use immediately.

12.SPECIAL WARNING(S)

Special precautions for use in animals: Vaccinate healthy animals only.

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.

In case of anaphylactic shock, appropriate symptomatic treatment should be administered.

Special precautions for 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:

Do not use in pregnant cats. The use is not recommended during lactation.

Interactions 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 and FELIGEN RCP. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after another veterinary medicinal product therefore needs to be made on a case by case basis.

Overdose (symptoms, emergency procedures, antidotes):

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 (from 5 to 6 weeks at the most).

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

Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).

15.OTHER INFORMATION

Immediate packaging:

A glass vial of 3 ml 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 N.V.

Esperantolaan 4

B-3001 Leuven

Tel: +31 (0) 342 427 127

Česká republika VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Danmark

VIRBAC Danmark A/S

Profilvej 1

6000 Kolding

Tel: 45 2219 1733

Deutschland

VIRBAC Tierarzneimittel GmbH

West Rögen 20

23843 Bad Oldesloe

Tel: 49 (4531) 805 555

Eesti

OÜ ZOOVETVARU Uusaru 5

76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006

E-mail: zoovet@zoovet.ee

Ελλάδα

VIRBAC HELLAS A.E.

rd Klm National Road Athens-Lamia 65 Agios Stefanos

Athens

Tel: +30 210 6219520 E-mail: info@virbac.gr

España

VIRBAC ESPAÑA S.A. 8950 Esplugues de Llobregat Barcelona

Tél: + 34 93 470 79 40

France

VIRBAC

1ère avenue 2065 m – L.I.D 06516 Carros

Tel.: 33 (0) 4 92 08 73 00 E-mail: dar@virbac.fr

Magyarország

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Malta

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Nederland

VIRBAC NEDERLAND BV

Hermesweg 15

3771 ND-Barneveld

Tel: 31 (0) 342 427 100

Norge

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Österreich

VIRBAC Österreich GmbH Hildebrandgasse 27

1180 Wien

Tel: 43 (0) 1 21 834 260

Република България VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Polska

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Portugal

VIRBAC DE Portugal

LABORATÓRIOS LDA

2080 Almeirim

Tel: (351) 243 570 500

Hrvatska

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Ireland

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: + 44 (0) 1359 243243

Island

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Italia

VIRBAC SRL

Via Ettore Bugatti 15

20142 Milano

Tel: 39 02 48 53 541

Κύπρος

GEO. PAVLIDES & ARAOUZOS LTD 25-27 Dimostheni Severi, 1080

1080 Nicosia

Τηλ: + 357 22456117

E-mail: theodosiou.vet@gpa.com.cy

Luxembourg/Luxemburg

VIRBAC BELGIUM S.A.

Esperantolaan 4

B-3001 Leuven

Tel: +31 (0) 342 427 127

România

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Slovenija

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Slovenská republika VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Suomi/Finland

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

Sverige

VIRBAC S.A.

1ère avenue 2065 m – L.I.D 06516 Carros

FRANCE

Tel: 33 (0) 4 92 08 73 00

United Kingdom

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: + 44 (0) 1359 243243

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