Broadline (eprinomectin, fipronil, praziquantel,...) – Labelling - QP54AASY

Updated on site: 08-Feb-2018

Medication name: Broadline
ATC: QP54AASY
Substance: eprinomectin, fipronil, praziquantel, (S)-methoprene
Manufacturer: Merial

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Box, pack sizes of 1, 3, 4, 6 or 15 applicators

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

BROADLINE spot-on solution for cats < 2.5 kg

BROADLINE spot-on solution for cats 2.5–7.5 kg

2.STATEMENT OF ACTIVE SUBSTANCES

Fipronil

24.9 mg

(S)-Methoprene

30.0 mg

Eprinomectin

1.20 mg

Praziquantel

24.9 mg

 

 

 

Fipronil

74.7 mg

(S)-Methoprene

90.0 mg

 

Eprinomectin

3.60 mg

 

Praziquantel

74.7 mg

 

3.PHARMACEUTICAL FORM

Spot-on solution

4.PACKAGE SIZE

0.3 ml

3 x 0.3 ml

4 x 0.3 ml

15 x 0.3 ml

0.9 ml

3 x 0.9 ml

4 x 0.9 ml

6 x 0.9 ml

15 x 0.9 ml

5.TARGET SPECIES

Cats

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Spot-on use.

External use only.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD(S)

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP

11.SPECIAL STORAGE CONDITIONS

Keep the applicator in the blister.

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

Disposal: read 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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MERIAL,

29 avenue Tony Garnier,

69007 Lyon

FRANCE

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/13/157/001 0.3 ml

EU/2/13/157/002 3 x 0.3 ml

EU/2/13/157/003 4 x 0.3 ml

EU/2/13/157/008 15 x 0.3 ml

EU/2/13/157/004 0.9 ml

EU/2/13/157/005 3 x 0.9 ml

EU/2/13/157/006 4 x 0.9 ml

EU/2/13/157/007 6 x 0.9 ml

EU/2/13/157/009 15 x 0.9 ml

17.MANUFACTURER’S BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNIT

Applicator

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

BROADLINE

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

0.3 ml

0.9 ml

3.ROUTE OF ADMINISTRATION

4.WITHDRAWAL PERIOD(S)

Not applicable.

5.BATCH NUMBER

Lot

6.EXPIRY DATE

EXP

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

Blister

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

BROADLINE spot-on solution for cats <2.5 kg

BROADLINE spot-on solution for cats 2.5–7.5 kg

2.NAME OF THE MARKETING AUTHORISATION HOLDER

MERIAL

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only

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