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:

A) 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.
B) 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.
C) 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.
D) 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 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.

Cytarabine Injection BP 2gm/20ml Technical Specification: 

Product Name:Cytarabine Injection BP
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 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.
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 BP 2gm Manufacturers, Suppliers in India:

Taj Pharma is a Cytarabine Injection Bp 2gm Manufacturer in India and Cytarabine Injection BP 2gm Exporter in India, an 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 well-known Cytarabine Injection BP 2gm supplier and 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:

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 and institutions & against the 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.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands as a trusted and reputable choice for individuals seeking Cytarabine Injection BP 2gm/1ml, particularly in the realm of cancer treatment. With a rich history and decades of experience in the pharmaceutical industry, Taj Pharmaceuticals boasts a deep understanding of oncology medications and their pivotal role in cancer care. Their commitment to maintaining the highest quality standards in the production of pharmaceuticals ensures that Cytarabine Injection is consistently efficacious and dependable. What sets Taj Pharmaceuticals apart is its global presence, functioning as not only a respected manufacturer in India but also as an exporter from India. This global reach extends the accessibility of critical cancer medications to patients and healthcare providers around the world, contributing significantly to the enhancement of cancer care on a global scale.

The advanced manufacturing facilities under Taj Pharmaceuticals’ purview, including the Taj Pharma plant in Vapi, Gujarat, operate in strict adherence to stringent quality control measures. This meticulous approach guarantees the precision and consistency of production, especially critical for oncology medications like Cytarabine Injection. Taj Pharmaceuticals has earned a well-deserved reputation for reliability among healthcare professionals, institutions, and patients. Their unwavering commitment to quality and safety in pharmaceuticals underscores their dedication to delivering essential, dependable medications for cancer treatment. Taj Pharmaceuticals embraces a patient-centric philosophy, prioritizing the well-being of those facing cancer. Their provision of reliable and high-quality cancer medications, exemplified by Cytarabine Injection BP 2gm/1ml, underscores their genuine commitment to improving the lives of individuals battling cancer and solidifies their status as a preferred choice for such critical medical needs.

What is Cytarabine Injection BP 2gm and its uses:

Cytarabine Injection BP 2gm is a medication used in the treatment of various forms of cancer, primarily hematological malignancies (cancers that affect blood cells) and some solid tumors. Here’s an overview of Cytarabine Injection and its primary uses:

Medication Type: Cytarabine, also known as cytosine arabinoside, is an antimetabolite medication. It interferes with the DNA synthesis of cancer cells, disrupting their ability to grow and divide.

Uses:

  • Acute Myeloid Leukemia (AML): Cytarabine is a cornerstone of treatment for AML, a type of cancer that affects myeloid blood cells. It is often used in combination with other chemotherapy agents to induce remission in AML patients.
  • Acute Lymphoblastic Leukemia (ALL): Cytarabine is sometimes used in the treatment of ALL, a cancer that affects lymphoid blood cells. It may be part of multiagent chemotherapy regimens for ALL.
  • Non-Hodgkin Lymphoma (NHL): Cytarabine is used in the treatment of certain types of NHL, particularly aggressive subtypes. It is usually combined with other chemotherapy drugs.
  • Hodgkin Lymphoma: In some cases, Cytarabine may be used as part of chemotherapy regimens for Hodgkin lymphoma.
  • Meningeal Leukemia: Cytarabine can be administered intrathecally (directly into the cerebrospinal fluid) to treat leukemia that has spread to the central nervous system.

How Does Cytarabine Injection BP 2gm Work?

Cytarabine Injection BP 2gm works by interfering with the DNA synthesis of rapidly dividing cancer cells, ultimately inhibiting their growth and causing cell death. Here’s a more detailed explanation of how Cytarabine works:

  • Incorporation into DNA: Cytarabine is structurally similar to one of the building blocks of DNA (deoxycytidine). When Cytarabine is administered, cancer cells take it up, mistaking it for a normal component of DNA.
  • Inhibition of DNA Synthesis: Once incorporated into the DNA molecule during the replication process, Cytarabine’s structure prevents the addition of more DNA building blocks (nucleotides) to the growing DNA chain. This acts as a roadblock in the DNA synthesis process.
  • Chain Termination: As Cytarabine is integrated into the DNA strand, it causes premature termination of the DNA chain. This means that the DNA cannot continue to replicate properly.
  • Interference with DNA Repair: Cytarabine also disrupts the cancer cell’s ability to repair damaged DNA, making it even more vulnerable to genetic errors.
  • Cell Cycle Arrest: Because DNA replication is a fundamental process in cell division, the interference caused by Cytarabine disrupts the cell cycle of cancer cells. This results in arrested cell division and ultimately cell death.
  • Selective Toxicity: Cytarabine primarily affects rapidly dividing cells, which includes cancer cells. Normal, healthy cells that divide more slowly are less affected, although they can still be impacted by the medication’s side effects.
  • Combination Therapy: Cytarabine is often used in combination with other chemotherapy agents that have different mechanisms of action. This combination therapy enhances the effectiveness of treatment by targeting cancer cells through multiple pathways.

Cytarabine’s ability to disrupt DNA synthesis and interfere with cancer cell division makes it a valuable component of chemotherapy regimens for various types of cancer, including leukemia and lymphoma. Its mechanism of action aims to halt the uncontrolled growth of cancer cells and induce cell death, ultimately contributing to the treatment and remission of cancer.

Benefits of Cytarabine Injection BP 2gm:

  • Effective Treatment for Hematologic Cancers: Cytarabine is highly effective in the treatment of hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and certain types of lymphoma. It is often a critical component of chemotherapy regimens used to induce remission in these cancers.
  • Selective Toxicity: Cytarabine primarily targets rapidly dividing cancer cells, which is a hallmark of many cancers. This selective toxicity makes it a valuable tool in cancer treatment while sparing normal, healthy cells that divide more slowly.
  • Enhanced Outcomes: When used in combination with other chemotherapy agents, Cytarabine can significantly improve the chances of achieving remission and long-term survival in patients with hematologic malignancies.
  • Intrathecal Use: Cytarabine can be administered intrathecally (directly into the cerebrospinal fluid) to treat leukemia that has spread to the central nervous system, providing a targeted approach to managing this complication.

Common Side Effects of Cytarabine Injection BP 2gm:

  • Bone Marrow Suppression: Cytarabine can lead to bone marrow suppression, resulting in decreased production of blood cells. This can lead to anemia (low red blood cells), thrombocytopenia (low platelet count), and neutropenia (low white blood cell count), increasing the risk of infections, bleeding, and fatigue.
  • Nausea and Vomiting: Gastrointestinal side effects, including nausea and vomiting, are common with Cytarabine treatment. These symptoms can be managed with antiemetic medications.
  • Mouth Sores: Some patients may develop mouth sores or ulcers during Cytarabine therapy, which can be painful and require symptomatic treatment.
  • Hair Loss: Temporary hair loss (alopecia) is possible with Cytarabine, but hair typically regrows after treatment is completed.
  • Skin Reactions: Skin reactions, such as rash or itching, can occur in some individuals.
  • Hepatic Dysfunction: Changes in liver function may occur, as indicated by elevated liver enzymes in blood tests.
  • Renal Dysfunction: Cytarabine can affect kidney function, although this is less common. Regular monitoring is important.
  • Fatigue: Many patients experience fatigue during treatment, which can impact their daily activities.
  • Neurological Effects: High-dose Cytarabine can sometimes lead to neurotoxicity, causing confusion, dizziness, or other neurological symptoms.

Frequently Asked Questions About Cytarabine Injection BP 2gm:

Certainly, here are some frequently asked questions (FAQs) about Cytarabine Injection BP 2gm:

What is Cytarabine Injection BP 2gm used for?

Cytarabine Injection is primarily used in the treatment of hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and certain types of lymphoma. It is often part of chemotherapy regimens to induce remission in these cancers.

How is Cytarabine Injection administered?

Cytarabine is typically administered intravenously (IV) or via intrathecal injection, depending on the specific treatment protocol and the type and stage of cancer being treated.

What is the mechanism of action of Cytarabine?

Cytarabine interferes with the DNA synthesis of rapidly dividing cancer cells, disrupting their ability to grow and divide. It is incorporated into the DNA molecule during replication, leading to chain termination and the prevention of further DNA synthesis.

Are there any special precautions or considerations before receiving Cytarabine?

Patients should inform their healthcare providers about any preexisting medical conditions, allergies, or medications they are taking. Regular blood tests are often necessary to monitor blood cell counts during treatment.

What are the common side effects of Cytarabine Injection?

Common side effects may include bone marrow suppression (low blood cell counts), nausea, vomiting, mouth sores, hair loss, fatigue, and skin reactions. However, side effects can vary in severity and may be managed with supportive care.

How long is the treatment duration with Cytarabine?

The duration of treatment with Cytarabine varies depending on the specific cancer diagnosis, the stage of the disease, and the treatment plan prescribed by the oncologist. Some treatment courses may last several weeks, while others may be shorter.

Can Cytarabine be used during pregnancy or breastfeeding?

The use of Cytarabine during pregnancy or breastfeeding should be carefully considered by healthcare providers, weighing the potential benefits against the risks. It is generally reserved for situations where the benefits clearly outweigh the potential risks.

Can Cytarabine cause long-term side effects?

Cytarabine can have long-term effects on fertility, and it may increase the risk of secondary cancers in some individuals. However, the risk of these effects must be weighed against the benefits of cancer treatment.

Is Cytarabine treatment painful?

Intravenous administration of Cytarabine may cause discomfort at the injection site, but pain can often be managed with appropriate techniques and medications.

Can patients continue their normal activities during Cytarabine treatment?

The ability to carry out normal activities may be limited during Cytarabine treatment, especially when experiencing side effects. Patients are encouraged to discuss their activity level with their healthcare team to ensure their safety and wellbeing.

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 the 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)
Contact the most reliable manufacturer of Cytarabine Injection BP 2gm, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274