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Canigen L4 (Inactivated Leptospira strains:L. interrogans...) – Labelling - QI07AB01

Updated on site: 08-Feb-2018

Medication name: Canigen L4
ATC: QI07AB01
Substance: Inactivated Leptospira strains:L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000); L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001); L. interrogans serogroup Australis serovar Bratislava (strain A
Manufacturer: Intervet International B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

BOX

Plastic box with 10, or 50 vials of 1 ml

Cardboard box with 1 vial of 10 ml

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Canigen L4 suspension for injection for dogs

2.STATEMENT OF ACTIVE SUBSTANCES

Read the package leaflet before use.

3.PHARMACEUTICAL FORM

Suspension for injection

4.PACKAGE SIZE

10x 1 ml (1 dose)

50x 1 ml (1 dose)

1x 10 ml (10 doses)

5.TARGET SPECIES

Dogs

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD(S)

Not applicable.

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

Once broached, use within 10 hours

11.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Protect from light.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Read the package leaflet before use.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only. To to be supplied only on veterinary prescription.

14.THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer

The Netherlands

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/15/183/001 – 10 vials (1 ml)

EU/2/15/183/002 – 50 vials (1 ml)

EU/2/15/183/003 – 1 vial (10 ml)

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL

1 ml and 10 ml vial

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Canigen L4

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

See package leaflet.

3.CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

1 ml (1 dose)

10 ml (10 doses)

4.ROUTE(S) OF ADMINISTRATION

SC

5.WITHDRAWAL PERIOD(S)

Not applicable.

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

Once broached, use within 10 hours. (just for 10 ml vials)

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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