a) Bortezomib for Injection 1mg
b) Bortezomib for Injection 2mg
c) Bortezomib for Injection 2.5mg
d) Bortezomib for Injection 3.5mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Bortezomib for Injection 1mg
Each vial contains:
Bortezomib……………………1mg
Excipients……………………...q.s.
b) Bortezomib for Injection 2mg
Each vial contains:
Bortezomib……………………2mg
Excipients………………………q.s.
c) Bortezomib for Injection 2.5mg
Each vial contains:
Bortezomib……………………2.5mg
Excipients………………………q.s.
d) Bortezomib for Injection 3.5mg
Each vial contains:
Bortezomib……………………3.5mg
Excipients……………………...q.s.
Each vial contains:
Bortezomib……………………1mg
Excipients……………………...q.s.
b) Bortezomib for Injection 2mg
Each vial contains:
Bortezomib……………………2mg
Excipients………………………q.s.
c) Bortezomib for Injection 2.5mg
Each vial contains:
Bortezomib……………………2.5mg
Excipients………………………q.s.
d) Bortezomib for Injection 3.5mg
Each vial contains:
Bortezomib……………………3.5mg
Excipients……………………...q.s.
THERAPEUTIC INDICATION:
Bortezomib used to treat multiple myeloma and mantle cell lymphoma.
DIRECTION OF USE:
1mg, 2mg, 2.5mg – for Intravenous use.
3.5mg - For Intravenous or Subcutaneous use.
Reconstitution for 3.5mg:
INTRAVENOUS INJECTION ONLY: Reconstitute with 3.5ml of sterile (0.9% w/v) Sodium Chloride solution for injection to make 1mg/ml final concentration.
SUBCUTANEOUS INJECTION ONLY: Reconstitute with 1.4ml of sterile (0.9% w/v) Sodium Chloride solution for Injection to make 2.5mg/ml final concentration.
3.5mg - For Intravenous or Subcutaneous use.
Reconstitution for 3.5mg:
INTRAVENOUS INJECTION ONLY: Reconstitute with 3.5ml of sterile (0.9% w/v) Sodium Chloride solution for injection to make 1mg/ml final concentration.
SUBCUTANEOUS INJECTION ONLY: Reconstitute with 1.4ml of sterile (0.9% w/v) Sodium Chloride solution for Injection to make 2.5mg/ml final concentration.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
The vial stopper is not made with natural rubber latex.
Discard Unused portion.
Keep out of the reach of the children.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
The vial stopper is not made with natural rubber latex.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Dosage: As directed by an Oncologist.
Dosage: As directed by an Oncologist.
Bortezomib for Injection 3.5mg Technical Specification:
| Product Name: | Bortezomib for Injection 3.5mg |
| Brand Name: | Norvelzo |
| Strength: | 1mg, 2mg, 2.5mg, 3.5mg |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | 1mg, 2mg, 2.5mg – for Intravenous use. 3.5mg – For Intravenous or Subcutaneous use. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Cancer |
| Indication: | Bortezomib used to treat multiple myeloma and mantle cell lymphoma. |
| Storage: | Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Bortezomib for Injection 3.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Bortezomib for Injection 3.5mg
Each vial contains:
Bortezomib……………………3.5mg
Excipients………………………q.s.
THERAPEUTIC INDICATION:
Bortezomib used to treat multiple myeloma and mantle cell lymphoma.
DIRECTION OF USE:
1mg, 2mg, 2.5mg – for Intravenous use.
3.5mg – For Intravenous or Subcutaneous use.
Reconstitution for 3.5mg:
INTRAVENOUS INJECTION ONLY: Reconstitute with 3.5ml of sterile (0.9% w/v) Sodium Chloride solution for injection to make 1mg/ml final concentration.
SUBCUTANEOUS INJECTION ONLY: Reconstitute with 1.4ml of sterile (0.9% w/v) Sodium Chloride solution for Injection to make 2.5mg/ml final concentration.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
The vial stopper is not made with natural rubber latex.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Dosage: As directed by an Oncologist.
