ProteqFlu (iInfluenza A/eq/Ohio/03 [H3N8] recombinant...) – Labelling - QI05AD02

Updated on site: 09-Feb-2018

Medication name: ProteqFlu
ATC: QI05AD02
Substance: iInfluenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) and influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011)
Manufacturer: Merial

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Outer package for 10 doses: 10 vials of 1 dose

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

ProteqFlu

Suspension for injection for horses

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

 

One dose of 1 ml contains:

 

 

 

Active substances:

 

 

 

Influenza A/eq/Ohio/03 [H3N8

] (vCP2242) ...............................................................

≥ 5.3 log10 FAID50

 

Influenza A/eq/Richmond/1/07 [H3N8] (vCP3011) ...................................................

≥ 5.3 log10 FAID50

 

Adjuvant:

 

 

 

Carbomer...........................................................................................................................................

 

4 mg.

 

 

 

 

 

3.

PHARMACEUTICAL FORM

 

 

 

 

 

 

 

Suspension for injection

 

 

 

 

 

 

4.

PACKAGE SIZE

 

 

 

10x1 ml (10 doses).

 

 

5.TARGET SPECIES

Horses

6.INDICATION(S)

Read the package leaflet before use.

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Withdrawal period: Zero days.

9.SPECIAL WARNING(S), IF NECESSARY

10.EXPIRY DATE

EXP

Use immediately after opening.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated (2 °C – 8 °C). 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 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/2/03/037/005

17.MANUFACTURER’S BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ProteqFlu

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Read the package leaflet before use.

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

1 dose

4. ROUTE(S) OF ADMINISTRATION

Intramuscular use

5.WITHDRAWAL PERIOD

Withdrawal period: Zero days.

6.BATCH NUMBER

Lot

7.EXPIRY DATE

EXP

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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