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- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent (Apidryl)
- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent (Apidryl) Technical Specification:
| Product Name: | Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent |
| Brand Name: | Apidryl |
| Strength: | 40mg/ml (20mg/0.5ml, 80mg/2 ml, 120mg/3ml) |
| Dosage Form: | Liquid Injection – Combi pack |
| Packing: | SINGLE DOSE VIAL |
| Route of Administration: | For I.V. use only |
| 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: | Docetaxel is a chemotherapy medication used to treat a number of types of cancer. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer. It may be used by itself or along with other chemotherapy medication. |
| Storage: | Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
Each combi pack contains
One vial of Docetaxel Injection USP 120mg/3ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………120mg
Anhydrous Citric Acid USP………………………….16.5mg
Polysorbate 80 USNF………………………………….3096mg
Accompanying with one vial of solvent for Docetaxel Injection 80mg
Each sterile vial contains
Alcohol USP…………………………1170mg
Water for Injection USP……….q.s. to 9.0ml
THERAPEUTIC INDICATION:
Docetaxel is a chemotherapy medication used to treat a number of types of cancer. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer. It may be used by itself or along with other chemotherapy medication.
PACKING:
40mg/ml
- 20mg/0.5ml
- 80mg/2 ml
- 120mg/3ml
DIRECTION OF USE:
For I.V. use only
Reconstitution for 120mg/3ml: Reconstitute using Solvent for Docetaxel Injection Concentrate 120mg. Rotate the vial gently and allow the premix to stand for 5 minutes. Use this Docetaxel Premix for further dilution. Use immediately after reconstitution.
See package insert for complete prescribing information.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
CAUTION: Cytotoxic Agent – Special Handling.
Instructions: Solvent for Docetaxel Concentrate USP to be used as diluent and not to be injected as such.
Retain in original package to protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Docetaxel Injection USP 40mg/ml (20mg/0.5ml) With Solvent
b) Docetaxel Injection USP 40mg/ml (80mg/2 ml) With Solvent
c) Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
b) Docetaxel Injection USP 40mg/ml (80mg/2 ml) With Solvent
c) Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Docetaxel Injection USP 40mg/ml (20mg/0.5ml) With Solvent
Each combi pack contains
One vial of Docetaxel Injection USP 20mg/0.5ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………20mg
Anhydrous Citric Acid USP………………………….2.75mg
Polysorbate 80 USNF………………………………….516mg
Accompanying with one vial of solvent for Docetaxel Injection 20mg
Each sterile vial contains
Alcohol USP……………………...…195mg
Water for Injection USP……....q.s. to 1.5ml
b) Docetaxel Injection USP 40mg/ml (80mg/2ml) With Solvent
Each combi pack contains
One vial of Docetaxel Injection USP 80mg/2ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………80mg
Anhydrous Citric Acid USP………………………….11mg
Polysorbate 80 USNF………………………………….2064mg
Accompanying with one vial of solvent for Docetaxel Injection 80mg
Each sterile vial contains
Alcohol USP……………………...…780mg
Water for Injection USP……....q.s. to 6.0ml
d) Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
Each combi pack contains
One vial of Docetaxel Injection USP 120mg/3ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………120mg
Anhydrous Citric Acid USP………………………….16.5mg
Polysorbate 80 USNF………………………………….3096mg
Accompanying with one vial of solvent for Docetaxel Injection 80mg
Each sterile vial contains
Alcohol USP……………………...…1170mg
Water for Injection USP……....q.s. to 9.0ml
Each combi pack contains
One vial of Docetaxel Injection USP 20mg/0.5ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………20mg
Anhydrous Citric Acid USP………………………….2.75mg
Polysorbate 80 USNF………………………………….516mg
Accompanying with one vial of solvent for Docetaxel Injection 20mg
Each sterile vial contains
Alcohol USP……………………...…195mg
Water for Injection USP……....q.s. to 1.5ml
b) Docetaxel Injection USP 40mg/ml (80mg/2ml) With Solvent
Each combi pack contains
One vial of Docetaxel Injection USP 80mg/2ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………80mg
Anhydrous Citric Acid USP………………………….11mg
Polysorbate 80 USNF………………………………….2064mg
Accompanying with one vial of solvent for Docetaxel Injection 80mg
Each sterile vial contains
Alcohol USP……………………...…780mg
Water for Injection USP……....q.s. to 6.0ml
d) Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
Each combi pack contains
One vial of Docetaxel Injection USP 120mg/3ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………120mg
Anhydrous Citric Acid USP………………………….16.5mg
Polysorbate 80 USNF………………………………….3096mg
Accompanying with one vial of solvent for Docetaxel Injection 80mg
Each sterile vial contains
Alcohol USP……………………...…1170mg
Water for Injection USP……....q.s. to 9.0ml
THERAPEUTIC INDICATION:
Docetaxel is a chemotherapy medication used to treat a number of types of cancer. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer. It may be used by itself or along with other chemotherapy medication.
PACKING:
40mg/ml
1) 20mg/0.5ml
2) 80mg/2 ml
3) 120mg/3ml
1) 20mg/0.5ml
2) 80mg/2 ml
3) 120mg/3ml
DIRECTION OF USE:
For I.V. use only
Reconstitution for 120mg/3ml: Reconstitute using Solvent for Docetaxel Injection Concentrate 120mg. Rotate the vial gently and allow the premix to stand for 5 minutes. Use this Docetaxel Premix for further dilution. Use immediately after reconstitution.
See package insert for complete prescribing information.
Reconstitution for 120mg/3ml: Reconstitute using Solvent for Docetaxel Injection Concentrate 120mg. Rotate the vial gently and allow the premix to stand for 5 minutes. Use this Docetaxel Premix for further dilution. Use immediately after reconstitution.
See package insert for complete prescribing information.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
CAUTION: Cytotoxic Agent – Special Handling.
Instructions: Solvent for Docetaxel Concentrate USP to be used as diluent and not to be injected as such.
Retain in original package to protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
CAUTION: Cytotoxic Agent – Special Handling.
Instructions: Solvent for Docetaxel Concentrate USP to be used as diluent and not to be injected as such.
Retain in original package to protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.
Dosage: As directed by the Oncologist.
