Bortezomib for Injection 2mg Technical Specification:

Product Name:Bortezomib for Injection 2mg
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 2mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bortezomib for Injection 2mg
    Each vial contains:
    Bortezomib……………………2mg
    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 2mg: Reconstitute with 2 ml of 0.9% Sodium Chloride Injection

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.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Bortezomib for Injection 1mg
b) Bortezomib for Injection 2mg
c) Bortezomib for Injection 2.5mg
d) Bortezomib for Injection 3.5mg

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.

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 2mg: Reconstitute with 2 ml of 0.9% Sodium Chloride Injection

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.