GENERIC NAME OF MEDICINAL PRODUCT:

(A) Carfilzomib for Injection 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Carfilzomib for Injection 60mg
Each vial contains:
Carfilzomib……………………….……60mg
Excipients………………………………..q. s.
Sterile Water for Injection IP.....30ml

THERAPEUTIC INDICATION:

Carfilzomib injection is used alone and in combination with dexamethasone, daratumumab and dexamethasone, or lenalidomide (Revlimid) and dexamethasone to treat people with multiple myeloma (a type of cancer of the bone marrow) who have already been treated with other medications.
This medication is used to treat a certain type of cancer (multiple myeloma). It works by helping to slow the growth and spread of cancer cells.

DIRECTION OF USE:

Reconstitution with 30ml of Sterile water for Injection IP After reconstitution with 29ml of Sterile Water for Injection IP, the concentration of Carfilzomib is 2mg/ml.

CAUTION AND SCHEDULE:

CAUTION: Do not use the injection if the contents visible particulate matter after reconstitution.
SCHEDULE: SCHEDULE 'G' PRESCRIPTION DRUG; WARNING: To be sold by retail on the prescription of an Oncologist only.

STORAGE AND DOSAGE:

STORAGE: Store between 2°C to 8°C. Store in carton to protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician

Carfilzomib for Injection 60mg Technical Specification

Product Name:Carfilzomib for Injection 60mg
Brand Name:Generic
Strength:60mg
Dosage Form:Lyophilized Powder Injection (Sterile)
Packing:1 Vial + WFI in Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-cancer (Multiple myeloma)
Indication: Carfilzomib injection is used dexamethasone to treat people with multiple myeloma. This medication is used to treat a certain type of cancer (multiple myeloma). It works by helping to slow the growth and spread of cancer cells.
Storage:Store between 2°C to 8°C. Store in carton to protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Carfilzomib for Injection 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Carfilzomib for Injection 60mg
    Each vial contains:

    Carfilzomib……………………….……60mg
    Excipients………………………………..q. s.
    Sterile Water for Injection IP…..30ml

THERAPEUTIC INDICATION:

Carfilzomib injection is used alone and in combination with dexamethasone, daratumumab and dexamethasone, or lenalidomide (Revlimid) and dexamethasone to treat people with multiple myeloma (a type of cancer of the bone marrow) who have already been treated with other medications.

This medication is used to treat a certain type of cancer (multiple myeloma). It works by helping to slow the growth and spread of cancer cells.

DIRECTION OF USE:

Reconstitution with 30ml of Sterile water for Injection IP
After reconstitution with 29ml of Sterile Water for Injection IP, the concentration of   Carfilzomib is 2mg/ml.

CAUTION AND SCHEDULE:

CAUTION: Do not use the injection if the contents visible particulate matter after reconstitution.
SCHEDULE: SCHEDULE ‘G’ PRESCRIPTION DRUG; WARNING: To be sold by retail on the prescription of an Oncologist only.

STORAGE AND DOSAGE:

STORAGE: Store between 2°C to 8°C. Store in carton to protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN

DOSAGE: As directed by Physician