Cytarabine Injection BP 2gm/20ml

Cytarabine Injection BP 2gm/20ml Technical Specification: 

Cytarabine Injection BP 2gm Manufacturers, Suppliers in India:

Taj Pharma is Cytarabine Injection Bp 2gm Manufacturer in India and Cytarabine Injection BP 2gm Exporter in India, Anti-Cancer medicine Supplier in Gujarat.

Taj Pharma is one of the prominent Cytarabine Injection BP 2gm Suppliers, Exporters & Manufacturers in PAN India. FDA & GMP Approved Contract Manufacturers.

Taj Pharma is well known Cytarabine Injection BP 2gm supplier & Manufacturer in PAN India. FDA & GMP Approved Contract Manufacturers, Exporter.

Taj Pharmaceuticals -Exporter and Supplier, FDA and GMP approved Manufacturers of Cytarabine Injection BP 2gm from Mumbai Maharashtra, India.

Taj Pharmaceuticals is a leading Manufacturer, Exporter & Supplier company of Cytarabine Injection BP 2gm at the Best price from Viramgam, Gujarat, India.

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Cytarabine Injection BP 1gm/10ml
• Cytarabine Injection BP 2gm/20ml
• Cytarabine Injection BP 500mg/5ml
•  Cytarabine Injection BP 100mg/1ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Cytarabine Injection BP 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 BP 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 BP 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 BP 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 BP 2gm in combination with other approved anticancer 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 BP 2gm Exporters; We can cater to export business queries from the following geographies. We are exporting our Cytarabine Injection BP 2gm 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 BP 2gm 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)