Cabazitaxel Injection 60mg/1.5ml Technical Specification:
| Product Name: | Cabazitaxel Injection |
| Brand Name: | Qtervaxia |
| Strength: | 60mg/1.5ml |
| Dosage Form: | Liquid Injection |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | For Intravenous Infusion only after Second Dilution |
| 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: | Cabazitaxel injection is given together with a steroid medicine to treat men with metastatic (cancer that has already spread) castration-resistant prostate cancer (prostate cancer that cannot be treated by surgery or medicines that lower testosterone). Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of cancer cells. |
| Storage: | Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Do not refrigerate. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cabazitaxel Injection 60mg/1.5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cabazitaxel Injection 60mg/1.5ml
Each vial OF 1.5ml of concentrate contains:
Cabazitaxel…………………………60mg
Excipients……………………………q.s. - Diluent for Cabazitaxel Injection
Each vial contains:
5.7ml of 13% (w/w) ethanol in water for Injection.
THERAPEUTIC INDICATION:
Cabazitaxel injection is given together with a steroid medicine to treat men with metastatic (cancer that has already spread) castration-resistant prostate cancer (prostate cancer that cannot be treated by surgery or medicines that lower testosterone). Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of cancer cells.
PACKING:
- 60mg/1.5ml
DIRECTION OF USE:
For Intravenous Infusion only after Second Dilution
When diluted with the Diluent, the first diluted solution contains 10mg/vial of cabazitaxel.
Two-step dilution required:
First Dilution: Add entire contents of the diluent (approximately 5.7 ml) to cabazitaxel to obtain a concentration of 10mg/ml.
Second Dilution: Withdraw the exact volume required from the 10mg/ml solution and dilute into 0.9% Sodium chloride or 5% dextrose solution to prepare the final infusion solution.
See package insert for full dilution information.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
DO NOT USE PVC INFUSION CONTAINERS OR POLYURETHANE INFUSIONS SETS FOR PREPRATION AND ADMINISTRATION OF CABAZITAXEL SOLUTION.
For Intravenous Infusion only after Second Dilution
WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
Cytotoxic Agent: Wear gloves at all times when handling containers.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Do not refrigerate.
Dosage: As directed by the Oncologist
GENERIC NAME OF THE MEDICINAL PRODUCT:
Cabazitaxel Injection 60mg/1.5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Cabazitaxel Injection 60mg/1.5ml
Each vial OF 1.5ml of concentrate contains:
Cabazitaxel………………………...60mg
Excipients…………………………...q.s.
Diluent for Cabazitaxel Injection
Each vial contains:
5.7ml of 13% (w/w) ethanol in water for Injection.
Each vial OF 1.5ml of concentrate contains:
Cabazitaxel………………………...60mg
Excipients…………………………...q.s.
Diluent for Cabazitaxel Injection
Each vial contains:
5.7ml of 13% (w/w) ethanol in water for Injection.
THERAPEUTIC INDICATION:
Cabazitaxel injection is given together with a steroid medicine to treat men with metastatic (cancer that has already spread) castration-resistant prostate cancer (prostate cancer that cannot be treated by surgery or medicines that lower testosterone). Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of cancer cells.
PACKING:
60mg/1.5ml
DIRECTION OF USE:
For Intravenous Infusion only after Second Dilution
When diluted with the Diluent, the first diluted solution contains 10mg/vial of cabazitaxel.
Two-step dilution required:
First Dilution: Add entire contents of the diluent (approximately 5.7 ml) to cabazitaxel to obtain a concentration of 10mg/ml.
Second Dilution: Withdraw the exact volume required from the 10mg/ml solution and dilute into 0.9% Sodium chloride or 5% dextrose solution to prepare the final infusion solution.
See package insert for full dilution information.
When diluted with the Diluent, the first diluted solution contains 10mg/vial of cabazitaxel.
Two-step dilution required:
First Dilution: Add entire contents of the diluent (approximately 5.7 ml) to cabazitaxel to obtain a concentration of 10mg/ml.
Second Dilution: Withdraw the exact volume required from the 10mg/ml solution and dilute into 0.9% Sodium chloride or 5% dextrose solution to prepare the final infusion solution.
See package insert for full dilution information.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
DO NOT USE PVC INFUSION CONTAINERS OR POLYURETHANE INFUSIONS SETS FOR PREPRATION AND ADMINISTRATION OF CABAZITAXEL SOLUTION.
For Intravenous Infusion only after Second Dilution
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
Cytotoxic Agent: Wear gloves at all times when handling containers.
Keep out of reach of children
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
DO NOT USE PVC INFUSION CONTAINERS OR POLYURETHANE INFUSIONS SETS FOR PREPRATION AND ADMINISTRATION OF CABAZITAXEL SOLUTION.
For Intravenous Infusion only after Second Dilution
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
Cytotoxic Agent: Wear gloves at all times when handling containers.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Do not refrigerate.
Dosage: As directed by the Oncologist.
Dosage: As directed by the Oncologist.
