Octanate Lv

Labeling of the Octanate LV, 200 IU/ml box set

(outer packaging)

1. NAME OF THE MEDICINAL PRODUCT

Octanate LV, 200 IU/ml,
Powder for solution for injection
Human coagulation factor VIII

2. CONTENT OF ACTIVE SUBSTANCE(S)

1000 IU of human coagulation factor VIII.
The product contains approximately 200 IU/ml of human coagulation factor VIII after reconstitution
in 5 ml of the supplied solvent.

3. LIST OF EXCIPIENTS

Excipients: sodium citrate, calcium chloride, sodium chloride, glycine.

4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGING

Powder for solution for injection
One vial contains 1000 IU of human coagulation factor VIII.

5. METHOD AND ROUTE OF ADMINISTRATION

For intravenous administration after reconstitution in the supplied solvent (water for injection 5 ml).
Read the package leaflet before using the medicinal product.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO

CHILDREN

Store the medicinal product in a place invisible and inaccessible to children .

7. OTHER SPECIAL WARNINGS, IF NECESSARY

For single-dose administration only.
Do not use a cloudy or not completely dissolved solution.

8. EXPIRY DATE

Expiry date:
Use immediately after reconstitution.

9. STORAGE CONDITIONS

Store in a refrigerator.
Store in the outer packaging to protect from light.
Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL

OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM

IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder:
Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium

12. NUMBER(S) OF THE MARKETING AUTHORISATION(S)

Marketing authorisation number: 22265

13. BATCH NUMBER

Batch number:

14. GENERAL CATEGORY OF AVAILABILITY

Medicinal product subject to medical prescription - Rp.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

Octanate LV 1000

17. UNIQUE IDENTIFIER – 2D CODE

Includes a 2D code that is a carrier of a unique identifier.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

FOR HUMAN

PC:
SN:
NN:

Labeling of the packaging with the set for reconstitution and administration

Octanate LV, 200 IU/ml (outer packaging)

1. NAME OF THE MEDICINAL PRODUCT

Packaging set for
Octanate LV, 200 IU/ml
Powder and solvent for solution for injection
Human coagulation factor VIII

2. CONTENT OF ACTIVE SUBSTANCE(S)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGING

Powder and solvent for solution for injection
EAN code: 5909991204143
Packaging set for reconstitution and administration
Packaging contains:
1 vial with 5 ml of water for injection
1 single-use syringe
1 transfer set
1 injection set
2 alcohol swabs

5. METHOD AND ROUTE OF ADMINISTRATION

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO

CHILDREN

Store the medicinal product in a place invisible and inaccessible to children .

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

9. STORAGE CONDITIONS

Store in a refrigerator.

10. SPECIAL PRECAUTIONS FOR DISPOSAL

OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM

IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder:
Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium

12. NUMBER(S) OF THE MARKETING AUTHORISATION(S)

22265

13. BATCH NUMBER

14. GENERAL CATEGORY OF AVAILABILITY

Medicinal product subject to medical prescription - Rp.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

Octanate LV 1000

17. UNIQUE IDENTIFIER – 2D CODE

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

FOR HUMAN

Labeling of the Octanate LV, 200 IU/ml vial (immediate packaging)

1. NAME OF THE MEDICINAL PRODUCT

Octanate LV, 200 IU/ml
Powder for solution for injection
Human coagulation factor VIII
For intravenous injection after reconstitution

2. CONTENT OF ACTIVE SUBSTANCE(S)

1000 IU of human coagulation factor VIII.

3. LIST OF EXCIPIENTS

Excipients: sodium citrate, calcium chloride, sodium chloride, glycine.

4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGING

Powder for solution for injection
1000 IU of human coagulation factor VIII.

5. METHOD AND ROUTE OF ADMINISTRATION

Read the package leaflet before using the medicinal product.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO

CHILDREN

Store in a place invisible and inaccessible to children .

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

Expiry date:

9. STORAGE CONDITIONS

Store in a refrigerator. Store in the outer packaging to protect from light. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL

OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM

IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder:
Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium

12. NUMBER(S) OF THE MARKETING AUTHORISATION(S)

Marketing authorisation number: 22265

13. BATCH NUMBER

Batch number:

14. GENERAL CATEGORY OF AVAILABILITY

Medicinal product subject to medical prescription - Rp.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

17. UNIQUE IDENTIFIER – 2D CODE

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

FOR HUMAN

Labeling of the solvent vial (immediate packaging)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Solvent for Octanate and Octanate LV

2. METHOD OF ADMINISTRATION

Read the package leaflet before using the medicinal product.

3. EXPIRY DATE

Expiry date:

4. BATCH NUMBER

Batch number:

5. CONTENT OF THE PACKAGING WITH MASS, VOLUME OR NUMBER OF UNITS

OF UNITS

5 ml of water for injection

6. OTHER

Marketing authorisation holder: