Bortezomib Medac
Italy
INFORMATION TO BE PRINTED ON THE SECONDARY PACKAGING
OUTER BOX
1. NAME OF THE MEDICINAL PRODUCT
Bortezomib medac 2.5 mg powder for solution for injection
bortezomib
2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE SUBSTANCE
Each vial contains 2.5 mg of bortezomib (as mannitol boronic ester).
3. LIST OF EXCIPIENTS
Mannitol (E 421)
4. PHARMACEUTICAL FORM AND CONTENTS
Powder for injectable solution
1 vial
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
For subcutaneous or intravenous use only.
Single-use product.
Do not administer by other routes.
Intravenous use: add 2.5 ml of Sodium Chloride 0.9% to achieve a final concentration of 1 mg/ml.
Subcutaneous use: add 1 ml of Sodium Chloride 0.9% to achieve a final concentration of 2.5 mg/ml.
6. SPECIAL WARNING TO KEEP THE MEDICINE OUT OF THE
SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER(S) SPECIAL PRECAUTION(S), IF NECESSARY
CYTOTOXIC PRODUCT. Special instructions for handling.
8. EXPIRY DATE
Expiry.
If not used immediately, reconstituted Bortezomib medac with 0.9% sodium chloride solution is stable for 8 hours at 25 °C/60% RH in the dark, both in the vial and in a polypropylene syringe.
9. SPECIAL STORAGE PRECAUTIONS
Keep the vial in the outer packaging to protect the medicine from light.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVED FROM SUCH MEDICINE, IF NECESSARY
Unused medicine and waste derived from such medicine must be disposed of in accordance with applicable local regulations.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
COMMERCIO
medac GmbH
Theaterstr. 6
22880 Wedel
Germany
12. MARKETING AUTHORISATION NUMBER(S)
AIC n° 046001032
13. BATCH NUMBER
Batch
14. SUPPLY CONDITION
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
17. UNIQUE IDENTIFIER - TWO-DIMENSIONAL BARCODE .
18. UNIQUE IDENTIFIER - READABLE DATA
PC:
SN:
NN:
BLUE BOX
Generic medicine
Price €
Stamp
For hospital, clinic and nursing home use only. Sale to the public prohibited.
May impair the ability to drive vehicles and operate machinery.
MINIMUM INFORMATION TO BE INDICATED ON PRIMARY PACKAGING OF
SMALL SIZES
VIAL
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Bortezomib medac 2.5 mg powder for solution for injection
bortezomib
For subcutaneous or intravenous use only.
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
Exp.
4. LOT NUMBER
Lot
5. CONTENT IN WEIGHT, VOLUME OR UNITS
2.5 mg
OTHER
Single-use product.
Do not administer by other routes.
Intravenous use: add 2.5 ml of Sodium Chloride 0.9% to obtain a final concentration of
1 mg/ml.
Subcutaneous use: add 1 ml of Sodium Chloride 0.9% to obtain a final concentration of
2.5 mg/ml.
CYTOTOXIC.
Keep the vial in the outer packaging to protect the medicinal product from light.
INFORMATION TO BE INDICATED ON THE SECONDARY PACKAGING
OUTER BOX
1. NAME OF THE MEDICINAL PRODUCT
Bortezomib medac 1 mg powder for solution for injection
bortezomib
2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE
SUBSTANCE
Each vial contains 1 mg of bortezomib (as mannitol boronic ester).
3. LIST OF EXCIPIENTS
Mannitol (E 421)
4. PHARMACEUTICAL FORM AND CONTENTS
Powder for injectable solution
1 vial
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the instruction leaflet before use.
For intravenous use only.
Single-use product.
Do not administer by other routes.
Intravenous use: add 1 ml of sodium chloride 0.9% to achieve the final concentration of
1 mg/ml.
6. SPECIAL PRECAUTION TO KEEP THE MEDICINE
KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep out of sight and reach of children.
7. OTHER(S) SPECIAL PRECAUTION(S), IF NECESSARY
CYTOTOXIC PRODUCT. Special instructions for handling.
8. EXPIRY DATE
Expiry.
If not used immediately, reconstituted Bortezomib medac with 0.9% sodium chloride solution is stable for 8 hours at 25 °C/60 % RH in the dark, both in the vial and in a polypropylene syringe.
9. SPECIAL STORAGE PRECAUTIONS
Keep the vial in the outer packaging to protect the medicine from light.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVED FROM SUCH MEDICINE, IF NECESSARY
Unused medicine and waste derived from such medicine must be disposed of in accordance with local applicable regulations.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
FOR PLACING ON THE MARKET
medac GmbH
Theaterstr. 6
22880 Wedel
Germany
12. MARKETING AUTHORISATION NUMBER(S)
AIC n. 046001018
13. BATCH NUMBER
Batch
14. GENERAL SUPPLY CONDITION
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
17. UNIQUE IDENTIFIER - TWO-DIMENSIONAL BARCODE .
18. UNIQUE IDENTIFIER - HUMAN-READABLE DATA
PC:
SN:
NN:
BLUE BOX REQUIREMENTS
Equivalency medicine
Price €
Optical barcode
For use in hospitals, clinics and nursing homes only. Sale to the public prohibited.
May impair the ability to drive vehicles and operate machinery.
MINIMUM INFORMATION TO BE INDICATED ON PRIMARY PACKAGING OF
SMALL SIZE
VIAL
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Bortezomib medac 1 mg powder for solution for injection
bortezomib
For intravenous use only.
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
Exp.
4. LOT NUMBER
Lot
5. CONTENT IN WEIGHT, VOLUME OR UNITS
1 mg
OTHER
INFORMATION TO BE INCLUDED ON THE SECONDARY PACKAGING
OUTER CARTON
1. NAME OF THE MEDICINAL PRODUCT
Bortezomib medac 3.5 mg powder for solution for injection
bortezomib
2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE
SUBSTANCE
Each vial contains 3.5 mg of bortezomib (as mannitol boronic ester).
3. LIST OF EXCIPIENTS
Mannitol (E 421)
4. PHARMACEUTICAL FORM AND CONTENTS
Powder for injectable solution
1 vial
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
For subcutaneous or intravenous use only.
Single-use product.
Do not administer by other routes.
Intravenous use: add 3.5 ml of sodium chloride 0.9 % to obtain a final concentration of 1 mg/ml.
Subcutaneous use: add 1.4 ml of sodium chloride 0.9 % to obtain a final concentration of 2.5 mg/ml.
6. SPECIAL WARNING TO KEEP THE MEDICINE
OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER PARTICULAR WARNING(S), IF NECESSARY
CYTOTOXIC PRODUCT. Special handling instructions.
8. EXPIRY DATE
Exp.
If not used immediately, reconstituted Bortezomib medac with sodium chloride 0.9% solution is stable for 8 hours at 25 °C/60% RH in the dark, both in the vial and in a polypropylene syringe.
9. SPECIAL STORAGE PRECAUTIONS
Keep the vial in the outer packaging to protect the medicine from light.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVED FROM SUCH MEDICINE, IF NECESSARY
Unused medicine and waste derived from such medicine must be disposed of in accordance with local applicable regulations.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
TO THE MARKET
medac GmbH
Theaterstr. 6
22880 Wedel
Germany
12. MARKETING AUTHORISATION NUMBER(S)
AIC n. 046001020
13. BATCH NUMBER
Batch
14. SUPPLY CONDITION
15. DIRECTIONS FOR USE
16. BRAILLE INFORMATION
17. UNIQUE IDENTIFIER - TWO-DIMENSIONAL BARCODE .
18. UNIQUE IDENTIFIER - HUMAN-READABLE DATA
PC:
SN:
NN:
BLUE BOX REQUIREMENTS
Equivalency medicine
Price €
Optical stamp
For use in hospitals, clinics and nursing homes only. Sale to the public prohibited.
May impair the ability to drive vehicles and operate machinery.
MINIMUM INFORMATION TO BE INDICATED ON PRIMARY PACKAGING OF
SMALL SIZES
VIAL
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Bortezomib medac 3.5 mg powder for solution for injection
bortezomib
For subcutaneous or intravenous use only.
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
Exp.
4. BATCH NUMBER
Batch
5. CONTENT IN WEIGHT, VOLUME OR UNITS
3.5 mg
OTHER