Cytarabine Injection USP 1gm/10ml
Cytarabine Injection USP 2gm/20ml
Cytarabine Injection USP 500mg/5ml
Cytarabine Injection USP 100mg/1ml
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Cytarabine Injection USP 1gm/10ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
B) Cytarabine Injection USP 2gm/20ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
C) Cytarabine Injection USP 500mg/5ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
D) Cytarabine Injection USP 100mg/1ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
B) Cytarabine Injection USP 2gm/20ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
C) Cytarabine Injection USP 500mg/5ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
D) Cytarabine Injection USP 100mg/1ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
THERAPEUTIC INDICATIONS:
Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute non-lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.
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.
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.
Dosage: As directed by the Oncologist.
Cytarabine Injection USP 100mg/1ml Technical Specification:
| Product Name: | Cytarabine Injection USP |
| Brand Name: | Cyotaj |
| Strength: | 1gm/10ml, 2gm/20ml, 500mg/5ml, 100mg/1ml |
| 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 Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute non-lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia. |
| 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]. |
Cytarabine Injection USP 100mg Manufacturers, Suppliers in India:
Taj Pharmaceuticals is of the prominent Cytarabine Injection USP 100mg Manufacturers in India that brings the best quality products. Our company Taj Pharma carries a rich experience in the niche manufacturing of Cytarabine Injection.
Taj Pharmaceuticals is a reputed manufacturer and Cytarabine Injection USP 100mg Suppliers in India prefer Taj Pharma is best known for the topmost standards and consistent quality of its products.
Taj Pharma is a well-known Cytarabine Injection USP 100mg Manufacturer in India that gives the assurance of high- quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.
Cytarabine Injection USP 100mg manufactured at Taj Pharma follows USP (United States Pharmacopeia); i.e. the product is manufactured to comply with USP quality standards which are considered the Best in the world. Further, Taj Pharma uses Cytarabine Injection USP grade best active ingredient to manufacture its Injections to comply with international standards of European products.
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cytarabine Injection USP 1gm/10ml
- Cytarabine Injection USP 2gm/20ml
- Cytarabine Injection USP 500mg/5ml
- Cytarabine Injection USP 100mg/1ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cytarabine Injection USP 1gm/10ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s. - Cytarabine Injection USP 2gm/20ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s. - Cytarabine Injection USP 500mg/5ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s. - Cytarabine Injection USP 100mg/1ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
THERAPEUTIC INDICATIONS:
Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute non-lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.
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.
As Cytarabine Injection USP 100mg Exporters; We can cater to export business queries from the following geographies. We are exporting our Cytarabine Injection USP 100mg product in Following Countries:
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Cytarabine Injection USP 100mg Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
