Medine.co.uk

Virbagen L

Revised: May 2012

AN: 01382/2011

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT


VIRBAGEN L

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION


Active ingredients: formula and titre per dose


Leptospira canicola

• titre before inactivation …………………………………

Leptospira icterohaemorrhagiae

• titre before inactivation …………………………………



833.106 bacteria/ml


833.106 bacteria/ml


0.038 ml of each, in buffered isotonic solution with residual culture medium.




For a full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM


Suspension for injection

4.

CLINICAL PARTICULARS

4.1

Target species


Dogs

4.2

Indications for use, specifying the target species


For the active immunisation of dogs from 8 weeks of age to reduce clinical signs of disease.

A serological response occurs by 3 weeks after the second dose.

The duration of protection lasts 12 months after immunisation.

4.3

Contraindications


Do not vaccinate females during pregnancy.

4.4

Special warnings


None


4.5

Special precautions for use

i.

Special precautions for use in animals


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

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

Vaccinate only healthy dogs.

Avoid exposure of the animal to infection for 21 days following vaccination

ii.

Special precautions for the person administering the veterinary medicinal product to animals


The active ingredients of the vaccine are inactivated but normal precautions should be taken to avoid contact with the skin and self-injection. In the event of accidental self-injection, seek medical advice immediately.

4.6

Adverse reactions (frequency and seriousness)


Transient itching, pain and/or swelling may occur at the injection site.

Occasional hypersensitivity reactions may occur but the incidence of these is rare. If anaphylactic reactions should occur, immediately administer corticotherapy (if possible, high doses by I.V. route) or antihistamines associated with usual treatment against anaphylactic shock.

4.7

Use during pregnancy, lactation or lay


Do not use in pregnant animals.

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 live canine distemper, canine adenovirus, canine parovirus and canine parainfluenza-virus vaccines.

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 any other veterinary medicinal product therefore needs to be decided on a case by case basis.

4.9

Amounts to be administered and administration route


Shake well before use.

Primary vaccination

- Puppies of 8-9 weeks of age can be subcutaneously administered one dose of 1 ml of VIRBAGEN L followed by another one 3-4 weeks later but never before the age of 12 weeks.

- Puppies older than 9 weeks can be subcutaneously administered one dose of 1 ml of VIRBAGEN L followed by another one 3-4 weeks later.

Booster vaccination

Annual revaccination with a single subcutaneous 1 ml dose of VIRBAGEN® L.

4.10

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


TTransient itching, pain and/or swelling similar to that described in section 4.6. may occur at the site of injection.

4.11

Withdrawal period


Not applicable

5.

IMMUNOLOGICAL PROPERTIES


ATC Vet Code: QI07AB01

To stimulate active immunity against Leptospira canicola and Leptospira ictero-haemorrhagiae.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients


Sucrose

Potassium hydrogen phosphate

Potassium dihydrogen phosphate

Tryptone

Water for injection

6.2

Incompatibilities


Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with live canine distemper, canine adenovirus, canine parovirus and canine parainfluenza-virus vaccines. Do not mix with any other veterinary medicinal product.

6.3

Shelf life


Shelf-life of the veterinary medicinal product as packaged for sale: 24 months

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

6.4

Special precautions for storage


Store and transport in the original package at a temperature of 4°C + 2°C. Protect from light. Do not freeze.


6.5

Nature and composition of immediate packaging


Containers

Insulin-type vial - 3 ml - Diameter 16, 25/38.5.

Neutral borosilicate type I glass complying with the European Pharmacopoeia, current edition.

Closures

Elastomer stoppers - Internal diameter 7 mm. External diameter 13 mm, complying with the European Pharmacopoeia, current edition.

Sealing

Perforated aluminium capsule.

Size

10 x 1 and 50 x 1 doses

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, if appropriate


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

7.

MARKETING AUTHORISATION HOLDER


Virbac S.A.

1ère avenue - 2065 m – L.I.D.

06516 Carros Cedex

France

8.

MARKETING AUTHORISATION NUMBER


Vm 05653/4047

9.

DATE OF FIRST AUTHORISATION


Date : 17 October 2005

10.

DATE OF REVISION OF THE TEXT


Date : May 2012


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