BORTEZOMIB MEDAC
ItalyThe drug must be used exclusively via intravenous or subcutaneous administration. It must not be administered through other routes.
Frequently asked questions
What are the preparation methods for Bortezomib medac?
For intravenous use, the powder must be mixed with 0.9% sodium chloride solution to obtain a concentration of 1 mg/ml. For subcutaneous use, it must be mixed with the same solution to obtain a concentration of 2.5 mg/ml. The exact amounts of solution to be added depend on the dosage of the vial used.
How long does the medicinal product remain stable after preparation?
Once reconstituted with 0.9% sodium chloride solution, the product is stable for 8 hours if stored in the dark at a temperature of 25 °C.
What are the storage precautions for Bortezomib medac?
The vial must be kept in the outer packaging to protect it from light.
Can the drug affect daily activities?
Yes, administration may alter the ability to drive vehicles or use machinery.
What type of product is this?
This is a cytotoxic, single-use product.
How should medicinal residues be disposed of?
Any unused medicinal product and waste derived from it should be disposed of in accordance with local regulations.
Instructions for use
Table of contents
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE SUBSTANCE
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING TO KEEP THE MEDICINE OUT OF THE
- 7. OTHER(S) SPECIAL PRECAUTION(S), IF NECESSARY
- 8. EXPIRY DATE
- 9. SPECIAL STORAGE PRECAUTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVED FROM SUCH MEDICINE, IF NECESSARY
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 17. UNIQUE IDENTIFIER - TWO-DIMENSIONAL BARCODE .
- 18. UNIQUE IDENTIFIER - READABLE DATA
- 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
- 4. LOT NUMBER
- 5. CONTENT IN WEIGHT, VOLUME OR UNITS
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL PRECAUTION TO KEEP THE MEDICINE
- 7. OTHER(S) SPECIAL PRECAUTION(S), IF NECESSARY
- 8. EXPIRY DATE
- 9. SPECIAL STORAGE PRECAUTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVED FROM SUCH MEDICINE, IF NECESSARY
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 17. UNIQUE IDENTIFIER - TWO-DIMENSIONAL BARCODE .
- 18. UNIQUE IDENTIFIER - HUMAN-READABLE DATA
- 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
- 4. LOT NUMBER
- 5. CONTENT IN WEIGHT, VOLUME OR UNITS
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING TO KEEP THE MEDICINE
- 7. OTHER PARTICULAR WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 9. SPECIAL STORAGE PRECAUTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVED FROM SUCH MEDICINE, IF NECESSARY
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 17. UNIQUE IDENTIFIER - TWO-DIMENSIONAL BARCODE .
- 18. UNIQUE IDENTIFIER - HUMAN-READABLE DATA
- 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
- 4. BATCH NUMBER
- 5. CONTENT IN WEIGHT, VOLUME OR UNITS
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
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The original data is available in the language of the country of manufacture.
Data source: Italian Medicines Agency (AIFA)
Data last verified: September 21, 2026