Octanate lv
Poland
Table of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. ACTIVE SUBSTANCE (YCH) CONTENT
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS OF THE CONTAINER
- 5. METHOD AND ADMINISTRATION ROUTE(S)
- 6. WARNING REGARDING STORAGE OF THE MEDICINAL PRODUCT
- 7. OTHER SPECIAL WARNINGS, IF NECESSARY
- 8. EXPIRY DATE
- 9. STORAGE INSTRUCTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL AVAILABILITY CATEGORY
- 17. UNIQUE IDENTIFIER – 2D CODE
- 18. UNIQUE IDENTIFIER – HUMAN-READABLE
- 1. NAME OF THE MEDICINAL PRODUCT
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. NUMBER(S) OF MARKETING AUTHORISATION(S)
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF ACTIVE SUBSTANCE(S)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
- 9. STORAGE INSTRUCTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. NUMBER(S) OF MARKETING AUTHORISATION(S)
- 13. BATCH NUMBER
- 14. GENERAL AVAILABILITY CATEGORY
- 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
- 2. METHOD OF ADMINISTRATION
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. CONTENTS OF THE PACKAGE IN TERMS OF MASS, VOLUME OR
- 6. OTHER
Labelling of the Octanate LV 200 IU/ml carton pack
(outer packaging)
1. NAME OF THE MEDICINAL PRODUCT
Octanate LV, 200 IU/ml,
Powder for solution for injection
Human coagulation factor VIII
2. ACTIVE SUBSTANCE (YCH) CONTENT
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 provided solvent.
3. LIST OF EXCIPIENTS
Excipients: sodium citrate, calcium chloride, sodium chloride, glycine.
4. PHARMACEUTICAL FORM AND CONTENTS OF THE CONTAINER
Powder for solution for injection
One vial contains 1000 IU of human coagulation factor VIII.
5. METHOD AND ADMINISTRATION ROUTE(S)
For intravenous administration after reconstitution in the provided solvent (water for injections 5 ml).
Read the instruction leaflet before use.
6. WARNING REGARDING STORAGE OF THE MEDICINAL PRODUCT
KEEP MEDICINE OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
For single-dose use only.
Do not use the solution if it is cloudy or not completely dissolved.
8. EXPIRY DATE
Expiry date:
Use immediately after reconstitution.
9. STORAGE INSTRUCTIONS
Store in the refrigerator.
Store in the outer packaging to protect from light.
Do not freeze.
10. SPECIAL PRECAUTIONS FOR DISPOSAL
OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL DERIVING 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. MARKETING AUTHORISATION NUMBER(S)
Authorisation number: 22265
13. BATCH NUMBER
Batch number:
14. GENERAL AVAILABILITY CATEGORY
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 serving as the carrier of the unique identifier.
18. UNIQUE IDENTIFIER – HUMAN-READABLE
DATA
PC:
SN:
NN:
Labelling of the pack containing the set for preparing solution and administration
Octanate LV, 200 IU/ml
(outer packaging)
1. NAME OF THE MEDICINAL PRODUCT
Packaging of the set for
Octanate LV, 200 IU/ml
Powder and solvent for solution for injection
Human coagulation factor VIII
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCE(S)
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS OF THE PACKAGE
Powder and solvent for solution for injection
EAN code: 5909991204143
Packaging set for reconstitution and administration
The pack contains:
1 vial with 5 ml of water for injections
1 single-use syringe
1 transfer set
1 administration set
2 alcohol-impregnated swabs
5. METHOD AND ROUTE(S) OF ADMINISTRATION
6. WARNING ON KEEPING THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
9. STORAGE CONDITIONS
Store in a refrigerator.
10. SPECIAL PRECAUTIONS FOR DISPOSAL
ANY UNUSED MEDICINAL PRODUCT OR WASTE DERIVING FROM SUCH
PRODUCTS, 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 MARKETING AUTHORISATION(S)
13. BATCH NUMBER
14. GENERAL AVAILABILITY CATEGORY
Prescription-only medicine - Rp.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
Octanate LV 1000
17. UNIQUE IDENTIFIER – 2D CODE
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
Labelling of the Octanate LV vial, 200 IU/ml
(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. COMPOSITION 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 PACKAGE CONTENTS
Powder for solution for injection
1000 IU of human coagulation factor VIII.
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the instruction leaflet before use.
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
OUT OF SIGHT AND REACH OF CHILDREN
Keep out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date:
9. STORAGE INSTRUCTIONS
Store in the refrigerator. Keep in the outer packaging to protect from light. Do not freeze.
10. SPECIAL PRECAUTIONS FOR DISPOSAL
UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL DERIVING FROM SUCH MEDICINAL PRODUCT, 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 MARKETING AUTHORISATION(S)
Authorisation number: 22265
13. BATCH NUMBER
Batch number:
14. GENERAL AVAILABILITY CATEGORY
Prescription-only medicine - Rp.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE
17. UNIQUE IDENTIFIER – 2D CODE
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
Labeling of the vial with solvent
(immediate packaging)
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Solvent for Octanate and Octanate LV
2. METHOD OF ADMINISTRATION
Read the instructions in the leaflet before using the medicine.
3. EXPIRY DATE
Expiry date:
4. BATCH NUMBER
Batch number:
5. CONTENTS OF THE PACKAGE IN TERMS OF MASS, VOLUME OR
NUMBER OF UNITS
5 ml of water for injections
6. OTHER
Marketing Authorisation Holder: