Cytarabine Injection BP 20mg/ml (500mg/25ml) Technical Specification:
| Product Name: | Cytarabine Injection BP 20mg/ml (500mg/25ml) |
| Brand Name: | Wirmelolife |
| Strength: | 20mg/ml (100mg/5ml, 500mg/25ml, 1000mg/50ml), 100mg/ml (100mg/1ml, 500mg/5ml, 1000mg/10ml, 2gm/20ml) |
| Dosage Form: | Liquid Injection |
| Packing: | SINGLE USE 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: | Cytarabine is used to treat acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and non-Hodgkin’s lymphoma |
| 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]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cytarabine Injection BP 20mg/ml (500mg/25ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cytarabine Injection BP 20mg/ml (500mg/25ml)
Each ml contains
Cytarabine USP……………………………..20mg
Sodium Hydroxide USNF……………….q.s.
Hydrochloric Acid USNF………………..q.s.
Water for Injection USP………………..q.s.
THERAPEUTIC INDICATION:
Cytarabine is used to treat acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and non-Hodgkin’s lymphoma
PACKING:
20mg/ml
- 100mg/5ml
- 500mg/25ml
- 1000mg/50ml
100mg/ml
- 100mg/1ml
- 500mg/5ml
- 1000mg/10ml
- 2gm/20ml
DIRECTION OF USE:
For I.V. use only
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: Cytotoxic agent – Special Handling
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.
WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions & against prescription of a Cancer Specialist only.
Cytotoxic Agent: Wear gloves at all times when handling containers.
OVERDOSAGE: There is no antidote for overdosage of Cytarabine Injection. Doses of 4.5 g/m2 by intravenous infusion over 1 hour every 12 hours for 12 doses have caused an unacceptable increase in irreversible CNS toxicity and death. Single doses as high as 3 g/m2 have been administered by rapid intravenous infusion without apparent toxicity.
NOTE: Only physicians experienced in cancer chemotherapy should use Cytarabine Injection.
IMPORTANT WARNING:
For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine injection is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Contains no antibacterial preservatives.
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].
Dosage: As directed by the Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Cytarabine Injection BP 20mg/ml (100mg/5ml, 500mg/25ml, 1000mg/50ml)
b) Cytarabine Injection BP 100mg/ml (100mg/1ml, 500mg/5ml, 1000mg/10ml, 2gm/20ml)
b) Cytarabine Injection BP 100mg/ml (100mg/1ml, 500mg/5ml, 1000mg/10ml, 2gm/20ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Cytarabine Injection BP 20mg/ml (100mg/5ml, 500mg/25ml, 1000mg/50ml)
Each ml contains
Cytarabine USP……………………………..20mg
Sodium Hydroxide USNF……………….q.s.
Hydrochloric Acid USNF………………..q.s.
Water for Injection USP………………..q.s.
b) Cytarabine Injection BP 100mg/ml (100mg/1ml, 500mg/5ml, 1000mg/10ml, 2gm/20ml)
Each ml contains
Cytarabine USP……………………………….100mg
Sodium Hydroxide USNF………………….q.s.
Hydrochloric Acid USNF…………………..q.s.
Water for Injection USP…………………..q.s.
Each ml contains
Cytarabine USP……………………………..20mg
Sodium Hydroxide USNF……………….q.s.
Hydrochloric Acid USNF………………..q.s.
Water for Injection USP………………..q.s.
b) Cytarabine Injection BP 100mg/ml (100mg/1ml, 500mg/5ml, 1000mg/10ml, 2gm/20ml)
Each ml contains
Cytarabine USP……………………………….100mg
Sodium Hydroxide USNF………………….q.s.
Hydrochloric Acid USNF…………………..q.s.
Water for Injection USP…………………..q.s.
THERAPEUTIC INDICATION:
Cytarabine is used to treat acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and non-Hodgkin's lymphoma
PACKING:
20mg/ml
1) 100mg/5ml
2) 500mg/25ml
3) 1000mg/50ml
100mg/ml
1) 100mg/1ml
2) 500mg/5ml
3) 1000mg/10ml
4) 2gm/20ml
1) 100mg/5ml
2) 500mg/25ml
3) 1000mg/50ml
100mg/ml
1) 100mg/1ml
2) 500mg/5ml
3) 1000mg/10ml
4) 2gm/20ml
DIRECTION OF USE:
For I.V. use only
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 after reconstitution. Fatal if given Intrathecally for Intravenous use only.
CAUTION: Cytotoxic agent – Special Handling.
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.
WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions & against prescription of a Cancer Specialist only.
Cytotoxic Agent: Wear gloves at all times when handling containers.
OVERDOSAGE: There is no antidote for overdosage of Cytarabine Injection. Doses of 4.5 g/m2 by intravenous infusion over 1 hour every 12 hours for 12 doses have caused an unacceptable increase in irreversible CNS toxicity and death. Single doses as high as 3 g/m2 have been administered by rapid intravenous infusion without apparent toxicity.
NOTE: Only physicians experienced in cancer chemotherapy should use Cytarabine Injection.
IMPORTANT WARNING:
For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine injection is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Contains no antibacterial preservatives.
Keep out of reach of children.
CAUTION: Cytotoxic agent – Special Handling.
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.
WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions & against prescription of a Cancer Specialist only.
Cytotoxic Agent: Wear gloves at all times when handling containers.
OVERDOSAGE: There is no antidote for overdosage of Cytarabine Injection. Doses of 4.5 g/m2 by intravenous infusion over 1 hour every 12 hours for 12 doses have caused an unacceptable increase in irreversible CNS toxicity and death. Single doses as high as 3 g/m2 have been administered by rapid intravenous infusion without apparent toxicity.
NOTE: Only physicians experienced in cancer chemotherapy should use Cytarabine Injection.
IMPORTANT WARNING:
For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine injection is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Contains no antibacterial preservatives.
Keep out of reach of children.
