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Vectra 3D (dinotefuran, permethrin, and pyriproxyfen) – Labelling - QP53AC54

Updated on site: 09-Feb-2018

Medication name: Vectra 3D
ATC: QP53AC54
Substance: dinotefuran, permethrin, and pyriproxyfen
Manufacturer: Ceva Sante Animale

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard boxes of 1, 3, 4, 6, 12, 24 and 48 spot-on applicators

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Vectra 3D spot-on solution for dogs 1.5–4 kg

Vectra 3D spot-on solution for dogs 4–10 kg

Vectra 3D spot-on solution for dogs 10–25 kg

Vectra 3D spot-on solution for dogs 25–40 kg

Vectra 3D spot-on solution for dogs > 40 kg

Dinotefuran / pyriproxyfen / permethrin

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each spot-on applicator contains dinotefuran 44 mg / pyriproxyfen 3.9 mg / permethrin 317 mg Each spot-on applicator contains dinotefuran 87 mg / pyriproxyfen 7.7 mg / permethrin 635 mg Each spot-on applicator contains dinotefuran 196 mg / pyriproxyfen 17.4 mg / permethrin 1429 mg Each spot-on applicator contains dinotefuran 256 mg / pyriproxyfen 22.7 mg / permethrin 1865 mg Each spot-on applicator contains dinotefuran 436 mg / pyriproxyfen 38.7 mg / permethrin 3175 mg

3.PHARMACEUTICAL FORM

Spot-on solution

4.PACKAGE SIZE

1 spot-on applicator

3spot-on applicators

4spot-on applicators

6spot-on applicators

12spot-on applicators

24spot-on applicators

48spot-on applicators

5.TARGET SPECIES

Dogs.

6.INDICATION(S)

Read the package leaflet before use.

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Spot-on use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

9.SPECIAL WARNING(S), IF NECESSARY

Do not use on cats.

Read the package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

11.SPECIAL STORAGE CONDITIONS

12. SPECIFIC 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

Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne FRANCE

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/13/156/001 (1 spot-on applicator for dogs 1.5–4 kg) EU/2/13/156/002 (3 spot-on applicators for dogs 1.5–4 kg) EU/2/13/156/026 (4 spot-on applicators for dogs 1.5–4 kg) EU/2/13/156/003 (6 spot-on applicators for dogs 1.5–4 kg) EU/2/13/156/004 (12 spot-on applicators for dogs 1.5–4 kg) EU/2/13/156/027 (24 spot-on applicators for dogs 1.5–4 kg) EU/2/13/156/005 (48 spot-on applicators for dogs 1.5–4 kg) EU/2/13/156/006 (1 spot-on applicator for dogs 4–10 kg)

EU/2/13/156/007 (3 spot-on applicators for dogs 4–10 kg) EU/2/13/156/028 (4 spot-on applicators for dogs 4–10 kg) EU/2/13/156/008 (6 spot-on applicators for dogs 4–10 kg) EU/2/13/156/009 (12 spot-on applicators for dogs 4–10 kg) EU/2/13/156/029 (24 spot-on applicators for dogs 4–10 kg) EU/2/13/156/010 (48 spot-on applicators for dogs 4–10 kg) EU/2/13/156/011 (1 spot-on applicator for dogs 10–25 kg) EU/2/13/156/012 (3 spot-on applicators for dogs 10–25 kg) EU/2/13/156/030 (4 spot-on applicators for dogs 10–25 kg) EU/2/13/156/013 (6 spot-on applicators for dogs 10–25 kg) EU/2/13/156/014 (12 spot-on applicators for dogs 10–25 kg) EU/2/13/156/031 (24 spot-on applicators for dogs 10–25 kg) EU/2/13/156/015 (48 spot-on applicators for dogs 10–25 kg) EU/2/13/156/016 (1 spot-on applicator for dogs 25–40 kg)

EU/2/13/156/017 (3 spot-on applicators for dogs 25–40 kg) EU/2/13/156/032 (4 spot-on applicators for dogs 25–40 kg) EU/2/13/156/018 (6 spot-on applicators for dogs 25–40 kg) EU/2/13/156/019 (12 spot-on applicators for dogs 25–40 kg) EU/2/13/156/033 (24 spot-on applicators for dogs 25–40 kg) EU/2/13/156/020 (48 spot-on applicators for dogs 25–40 kg) EU/2/13/156/021 (1 spot-on applicator for dogs > 40 kg)

EU/2/13/156/022 (3 spot-on applicators for dogs > 40 kg) EU/2/13/156/034 (4 spot-on applicators for dogs > 40 kg) EU/2/13/156/023 (6 spot-on applicators for dogs > 40 kg) EU/2/13/156/024 (12 spot-on applicators for dogs > 40 kg) EU/2/13/156/035 (24 spot-on applicators for dogs > 40 kg) EU/2/13/156/025 (48 spot-on applicators for dogs > 40 kg)

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Spot-on applicator label

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Vectra 3D spot-on (1.5–4 kg)

Vectra 3D spot-on (4–10 kg)

Vectra 3D spot-on (10–25 kg)

Vectra 3D spot-on (25–40 kg)

Vectra 3D spot-on (> 40 kg)

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

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

4.ROUTE(S) OF ADMINISTRATION

Spot-on use

5.WITHDRAWAL PERIOD

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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