Oxaliplatin Injection USP (100mg) Technical Specification:

Product Name:Oxaliplatin Injection USP
Brand Name:Generic
Strength:(50mg), (100mg) 
Dosage Form:Liquid Innjection
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: Oxaliplatin is also used with other medications to prevent colon cancer from spreading in people who have had surgery to remove the tumour. It works by killing cancer cells.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Oxaliplatin Injection USP 100mg Manufacturers, Suppliers in India:

Taj Pharmaceuticals is of the prominent Oxaliplatin 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 Oxaliplatin Injection USP 100mg.

Taj Pharmaceuticals is a reputed manufacturer and Oxaliplatin Injection USP 100mg Suppliers in India prefer Taj Generics is best known for its products’ topmost standards and consistent quality.

Taj Generics is a well-known Oxaliplatin Injection USP 100mg 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.

Oxaliplatin Injection USP 100mg manufactured at Taj Pharma. the product is manufactured to comply with good quality standards which are considered the Best in the world. Further, Taj Generics uses Oxaliplatin Injection USP 100mg grade best active ingredient to manufacture its Injections to comply with international standards of European products.

 GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Oxaliplatin Injection USP 50mg
  • Oxaliplatin Injection USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Oxaliplatin Injection USP 50mg
    Each vial contains:
    Oxaliplatin USP……………………50mg
    Lactose monohydrate NF……450mg
  • Oxaliplatin Injection USP 100mg
    Each vial contains:

    Oxaliplatin USP……………………100mg
    Lactose monohydrate NF…….900mg

THERAPEUTIC INDICATION:

Oxaliplatin is also used with other medications to prevent colon cancer from spreading in people who have had surgery to remove the tumour. It works by killing cancer cells.

DIRECTION OF USE:

For Intravenous Use only.

Please refer accompanying package insert for detailed dosage, directions for use and precautions.

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: This is a potent cytotoxic agent. Use only after reading the directions on the package insert.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.

NOTE: Oxaliplatin Injection should not be administered with needles or intravenous sets containing aluminium components.

Do not reconstitute with Sodium Chloride/ Chloride containing solution.

REFRIGERATED PRODUCT

Preservative Free

Must be reconstituted and diluted before use

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard the unused portion.

Keep out of the reach of the 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°F to 86°F) [see USP Controlled Room Temperature].

Dosage: As directed by an Oncologist.

Why Taj Pharmaceuticals?

Experience unmatched quality and reliability with Taj Pharmaceuticals for Oxaliplatin Injection. As a renowned pharmaceutical leader, Taj Pharmaceuticals stands out for its exceptional commitment to delivering top-notch healthcare solutions. Our Oxaliplatin Injection is meticulously manufactured to the highest industry standards, ensuring safety and effectiveness for patients undergoing cancer treatment. Taj Pharmaceuticals prioritizes quality at every step of the production process, from sourcing premium raw materials to employing advanced manufacturing techniques.

What sets Taj Pharmaceuticals apart is its unwavering dedication to innovation. Our research and development teams work tirelessly to enhance drug formulations, optimize delivery mechanisms, and improve patient experiences. This dedication to innovation enables us to offer cutting-edge pharmaceutical solutions that meet the evolving needs of healthcare professionals and patients alike.

When you choose Taj Pharmaceuticals, you’re not only choosing a product; you’re choosing a partner in healthcare. Our commitment extends beyond product quality to encompass comprehensive support for healthcare providers and patients. We provide clear and accurate information, comprehensive educational resources, and responsive customer service to ensure that medical professionals have the tools they need to make informed treatment decisions. Taj Pharmaceuticals’ legacy of excellence, combined with our focus on innovation and commitment to healthcare, make us the preferred choice for Oxaliplatin Injection. Trust us to deliver safe, effective, and reliable pharmaceutical solutions that contribute to better patient outcomes and improved quality of life.

What are Oxaliplatin Injection and its uses?

Taj Pharmaceuticals’ Oxaliplatin Injection is a medication used in the treatment of certain types of cancer, particularly colorectal cancer. It belongs to a class of drugs known as platinum-based chemotherapy agents. Oxaliplatin works by interfering with the DNA inside cancer cells, preventing their ability to replicate and divide. This ultimately leads to the death of cancer cells and helps to slow down or stop the growth of the tumor.

Uses of Oxaliplatin Injection:

  • Colorectal Cancer: Oxaliplatin is commonly used in combination with other chemotherapy drugs for the treatment of advanced or metastatic colorectal cancer. It is often part of a regimen known as FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin), which has shown significant efficacy in shrinking tumors and extending survival in patients with advanced colorectal cancer.
  • Adjuvant Treatment: Oxaliplatin is also used as adjuvant therapy, which means it is given after surgery to reduce the risk of cancer recurrence. It is used in combination with other chemotherapy agents to target any remaining cancer cells that might not have been removed during surgery.
  • Other Cancers: While its primary use is in colorectal cancer, oxaliplatin may also be used in combination with other drugs to treat certain other types of cancer, such as advanced gastric (stomach) cancer.

It’s important to note that the use of oxaliplatin is determined by a healthcare professional based on the individual patient’s medical condition, stage of cancer, overall health, and potential side effects. Like all chemotherapy drugs, oxaliplatin can cause side effects, which can range from mild to severe and may include nausea, vomiting, diarrhea, nerve damage (neuropathy), and low blood cell counts.

Patients receiving oxaliplatin or any chemotherapy should have a thorough discussion with their healthcare provider to understand the potential benefits and risks of the treatment and to ensure they receive appropriate supportive care throughout their treatment journey.

How Does Oxaliplatin Injection Work?

Oxaliplatin is a platinum-based chemotherapy drug that works by interfering with the DNA replication process in rapidly dividing cancer cells. Its mechanism of action involves forming DNA cross-links, which disrupt the normal structure of DNA and prevent cancer cells from dividing and proliferating. Here’s a more detailed explanation of how Oxaliplatin Injection works:

  • Formation of DNA Cross-Links: Oxaliplatin is administered into the bloodstream, and it travels to the cancer cells within the body. Inside the cancer cells, oxaliplatin undergoes a chemical reaction that leads to the formation of platinum-DNA adducts. These adducts are cross-links between the strands of DNA, which means they create abnormal bonds between DNA molecules.
  • Interference with DNA Replication: The presence of these cross-links in the DNA strands hinders the normal processes of DNA replication and transcription. DNA replication is essential for cancer cell division and growth. By disrupting this process, oxaliplatin effectively prevents cancer cells from making accurate copies of their DNA, a crucial step for their survival and multiplication.
  • Activation of Cellular Response: The formation of DNA cross-links triggers cellular stress responses within the cancer cells. Cells attempt to repair the DNA damage caused by oxaliplatin, but these repair processes can be overwhelmed and ineffective due to extensive cross-linking. As a result, the cells may enter a state of apoptosis, also known as programmed cell death.
  • Apoptosis and Cell Death: When cancer cells recognize that the DNA damage is too severe to repair, they activate a series of signals that initiate the apoptotic pathway. Apoptosis is a controlled process of cell death that occurs in response to irreparable cellular damage. The cancer cells undergo fragmentation and are subsequently cleared by the body’s immune system or eliminated through other mechanisms.

Benefits of Oxaliplatin Injection:

Here are some general benefits associated with oxaliplatin injection, which are applicable to most formulations of this chemotherapy drug:

  • Effective Colorectal Cancer Treatment: Oxaliplatin is a key component of many chemotherapy regimens used to treat advanced or metastatic colorectal cancer. It has demonstrated efficacy in reducing tumor size, slowing disease progression, and improving overall survival rates in patients with this type of cancer.
  • Adjuvant Therapy: Oxaliplatin is also used as adjuvant therapy after surgical removal of the primary tumor. This means it helps reduce the risk of cancer recurrence by targeting any remaining cancer cells that might not have been removed during surgery.
  • Combined Treatment Approaches: Oxaliplatin is often used in combination with other chemotherapy drugs and medications, increasing its effectiveness by attacking cancer cells through multiple mechanisms. These combinations can provide a more comprehensive treatment approach.
  • Response to Platinum Agents: Some cancer cells are particularly sensitive to platinum-based chemotherapy agents like oxaliplatin. This makes it a valuable treatment option for patients with cancers that exhibit this sensitivity.
  • Potential for Tumor Shrinkage: Oxaliplatin can lead to a reduction in tumor size, which may relieve symptoms associated with the tumor and improve the patient’s quality of life.
  • Customized Treatment: Oncologists tailor treatment plans based on the individual patient’s medical history, cancer type, stage, and overall health. Oxaliplatin can be part of a personalized treatment strategy.

Side Effects of Oxaliplatin Injection:

It’s important to recognize that while oxaliplatin can be effective in treating cancer, it can also lead to various side effects due to its impact on rapidly dividing cells, both cancerous and healthy. The severity of these side effects can vary from person to person and may depend on factors such as dosage, treatment duration, and individual sensitivity. Some common side effects include:

  • Neuropathy: One of the hallmark side effects of oxaliplatin is peripheral neuropathy, which is characterized by tingling, numbness, and sensitivity to cold in the hands and feet. This can affect daily activities and may persist even after treatment ends.
  • Nausea and Vomiting: Chemotherapy-induced nausea and vomiting are possible side effects, although antiemetic medications can help manage these symptoms.
  • Diarrhea or Constipation: Gastrointestinal disturbances like diarrhea or constipation can occur, and proper management and hydration are important.
  • Bone Marrow Suppression: Oxaliplatin can suppress bone marrow function, leading to decreased production of blood cells, which may result in anemia, increased susceptibility to infections, and bleeding tendencies.
  • Fatigue: Cancer treatment, including oxaliplatin, can lead to fatigue, which may impact daily activities and quality of life.
  • Allergic Reactions: While rare, allergic reactions to oxaliplatin can occur, which may include symptoms like rash, difficulty breathing, and swelling.
  • Electrolyte Imbalance: Oxaliplatin treatment can lead to changes in electrolyte levels in the body, which may require monitoring and management.

Frequently Asked Questions About Oxaliplatin Injection:

Certainly, here are some frequently asked questions about Oxaliplatin Injection and its use in cancer treatment:

What is Oxaliplatin Injection used for?

Oxaliplatin Injection is a chemotherapy medication primarily used in the treatment of colorectal cancer. It is often used in combination with other drugs to target cancer cells and inhibit their growth.

How does Oxaliplatin Injection work?

Oxaliplatin works by forming DNA cross-links within cancer cells, disrupting their ability to replicate and divide. This ultimately leads to cell death and slows down tumor growth.

Is Oxaliplatin Injection used for other types of cancer?

While its primary use is in colorectal cancer, Oxaliplatin Injection can also be used in combination with other drugs to treat other types of cancers, such as advanced gastric cancer.

How is Oxaliplatin Injection administered?

Oxaliplatin is typically administered as an intravenous infusion, meaning it is delivered directly into a vein. The exact dosage and treatment schedule depend on the patient’s specific condition and the treatment plan.

What are the common side effects of Oxaliplatin Injection?

Common side effects of Oxaliplatin Injection can include peripheral neuropathy (tingling and numbness in hands and feet), nausea, vomiting, diarrhea, fatigue, and decreased blood cell counts. These side effects can vary in severity and are managed by healthcare professionals.

How is peripheral neuropathy managed during Oxaliplatin treatment?

Peripheral neuropathy, a common side effect, can be managed by adjusting the dosage, temporarily discontinuing treatment, or using medications to alleviate symptoms. Patients should inform their healthcare provider if they experience neuropathy symptoms.

Can Oxaliplatin Injection be used during pregnancy?

Oxaliplatin is generally not recommended during pregnancy due to potential risks to the developing fetus. Pregnant individuals should discuss the potential risks and benefits with their healthcare provider.

What is the difference between adjuvant and palliative use of Oxaliplatin Injection?

Adjuvant use refers to giving Oxaliplatin Injection after surgical removal of a tumor to reduce the risk of cancer recurrence. Palliative use involves using the drug to relieve symptoms and slow tumor growth in advanced or metastatic cancer cases.

Are there any interactions with other medications?

Patients should inform their healthcare provider about all medications they are taking, as some drugs can interact with Oxaliplatin Injection. It’s important to receive guidance on potential interactions.

How often will I need to receive Oxaliplatin Injection?

The frequency of Oxaliplatin Injection can vary based on the treatment plan, the specific cancer type, and the stage of the disease. Your oncologist will determine the appropriate treatment schedule.

Oxaliplatin Injection USP 100mg Exporters; We can cater to export business queries from the following geographies. We are exporting our Oxaliplatin 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, and 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

Oxaliplatin 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)
Contact the most reliable manufacturer of Oxaliplatin Injection, 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Oxaliplatin Injection USP 50mg
b) Oxaliplatin Injection USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Oxaliplatin Injection USP 50mg
Each vial contains:
Oxaliplatin USP……………………50mg
Lactose monohydrate NF……450mg

b) Oxaliplatin Injection USP 100mg
Each vial contains:
Oxaliplatin USP……………………100mg
Lactose monohydrate NF…….900mg

THERAPEUTIC INDICATION:

Oxaliplatin is also used with other medications to prevent colon cancer from spreading in people who have had surgery to remove the tumor. It works by killing cancer cells.

DIRECTION OF USE:

For Intravenous Use only.
Please refer accompanying package insert for detailed dosage, directions for use and precautions.

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: 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 only.
NOTE: Oxaliplatin for Injection should not be administered with needles or intravenous sets containing aluminum components.
Do not reconstitute with Sodium Chloride/ Chloride containing solution.
REFRIGERATED PRODUCT
Preservative Free
Must be reconstituted and diluted before use
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the 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°F to 86°F) [see USP Controlled Room Temperature].
Dosage: As directed by an Oncologist.