Etoposide Injection USP 20mg/ml (1g/50ml) (Lifepoyz) Technical Specification:
| Product Name: | Etoposide Injection USP 20mg/ml (1g/50ml) |
| Brand Name: | Lifepoyz |
| Strength: | 20mg/ml (100mg/5ml, 250mg/12.5ml, 500mg/25ml,1g/50ml) |
| Dosage Form: | Liquid Injection |
| Packing: | MULTI DOSE VIAL |
| Route of Administration: | For I.V. use only – Must be diluted before |
| 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: | Etoposide is a chemotherapy medication used for the treatments of a number of types of cancer including testicular cancer, lung cancer, lymphoma, leukemia, neuroblastoma, and ovarian cancer. |
| Storage: | Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Etoposide Injection USP 20mg/ml (1g/50ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Etoposide Injection USP 20mg/ml (1g/50ml)
Each ml contains
Etoposide USP………………………………………20mg
Anhydrous citric acid…………………………….2mg
Benzyl alcohol………………………………………30 mg
Polysorbate tween 80……….…………………80mg
Polyethylene glycol 300……………………….650mg
Dehydrated alcohol…………………………….30.5%(v/v)
THERAPEUTIC INDICATION:
Etoposide is a chemotherapy medication used for the treatments of a number of types of cancer including testicular cancer, lung cancer, lymphoma, leukemia, neuroblastoma, and ovarian cancer.
PACKING:
20mg/ml
- 100mg/5ml
- 250mg/12.5ml
- 500mg/25ml
- 1g/50ml
DIRECTION OF USE:
For I.V. use only – Must be diluted before
See package insert for complete prescribing information.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNING: Severe lowering of blood counts (myelosuppression) may occur, which may cause or bleeding (sometimes fatal). Seek immediate medical attention if you develop symptoms of infection (fever, chills, persistent sore throat) or usually easy bruising or bleeding.
ETOPOSIDE IS AN ANTI-NEOPLASTIC DRUG FOR INTRAVENOUS OR ORAL USE, WHICH CAN BE USED ALONE OR IN COMBINATION WITH OTHER ONCOLYTIC DRUGS.
Not to be used in newly born or premature infants.
ANTINEOPLASTIC AGENT, ENZYME TOPOISOMERASE INHIBITOR
The container closure in not made with natural rubber latex.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Protect from light. Do not freeze.
Dosage: As directed by the Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Etoposide Injection USP 20mg/ml (100mg/5ml, 250mg/12.5ml, 500mg/25ml,1g/50ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Etoposide Injection USP 20mg/ml (100mg/5ml, 250mg/12.5ml, 500mg/25ml,1g/50ml)
Each ml contains
Etoposide USP………………………………………20mg
Anhydrous citric acid…………………………….2mg
Benzyl alcohol………………………………………30 mg
Polysorbate tween 80..........…………………80mg
Polyethylene glycol 300……………………….650mg
Dehydrated alcohol…………………………….30.5%(v/v)
Each ml contains
Etoposide USP………………………………………20mg
Anhydrous citric acid…………………………….2mg
Benzyl alcohol………………………………………30 mg
Polysorbate tween 80..........…………………80mg
Polyethylene glycol 300……………………….650mg
Dehydrated alcohol…………………………….30.5%(v/v)
THERAPEUTIC INDICATION:
Etoposide is a chemotherapy medication used for the treatments of a number of types of cancer including testicular cancer, lung cancer, lymphoma, leukemia, neuroblastoma, and ovarian cancer.
PACKING:
20mg/ml
1) 100mg/5ml
2) 250mg/12.5ml
3) 500mg/25ml
4) 1g/50ml
1) 100mg/5ml
2) 250mg/12.5ml
3) 500mg/25ml
4) 1g/50ml
DIRECTION OF USE:
For I.V. use only – Must be diluted before
See package insert for complete prescribing information.
See package insert for complete prescribing information.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNING: Severe lowering of blood counts (myelosuppression) may occur, which may cause or bleeding (sometimes fatal). Seek immediate medical attention if you develop symptoms of infection (fever, chills, persistent sore throat) or usually easy bruising or bleeding.
ETOPOSIDE IS AN ANTI-NEOPLASTIC DRUG FOR INTRAVENOUS OR ORAL USE, WHICH CAN BE USED ALONE OR IN COMBINATION WITH OTHER ONCOLYTIC DRUGS.
Not to be used in newly born or premature infants.
ANTINEOPLASTIC AGENT, ENZYME TOPOISOMERASE INHIBITOR
The container closure in not made with natural rubber latex.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNING: Severe lowering of blood counts (myelosuppression) may occur, which may cause or bleeding (sometimes fatal). Seek immediate medical attention if you develop symptoms of infection (fever, chills, persistent sore throat) or usually easy bruising or bleeding.
ETOPOSIDE IS AN ANTI-NEOPLASTIC DRUG FOR INTRAVENOUS OR ORAL USE, WHICH CAN BE USED ALONE OR IN COMBINATION WITH OTHER ONCOLYTIC DRUGS.
Not to be used in newly born or premature infants.
ANTINEOPLASTIC AGENT, ENZYME TOPOISOMERASE INHIBITOR
The container closure in not made with natural rubber latex.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Protect from light. Do not freeze.
Dosage: As directed by the Oncologist.
Protect from light. Do not freeze.
Dosage: As directed by the Oncologist.
