Octanate Lv
How to use 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:
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterOctapharma AB Octapharma Pharmazeutika Produktions.ges.m.b.H. Octapharma S.A.S.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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