Vinorelbine Injection USP 50mg/5ml Technical Specification: 

Product Name:Vinorelbine Injection USP 50mg/5ml
Brand Name:Vinorelbine
Strength:10mg/ml, 50mg/5ml
Dosage Form:Liquid Injection
Packing:SINGLE-USE VIAL
Route of Administration:For I.V. use only – Must be diluted before
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: Vinorelbine is used alone and in combination with other medications to treat non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body.
Storage:Store the vials in the original cartons between 2°C to 8°C (36° F to 46° F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Vinorelbine Injection USP 50mg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Vinorelbine Injection USP 50mg/5ml
    Each ml contains
    Vinorelbine tartrate USP
    Equivalent to Vinorelbine………….10mg
    Water for Injection USP………………q.s.

THERAPEUTIC INDICATION:

Vinorelbine is used alone and in combination with other medications to treat non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body.

PACKING:

10mg/ml

  • 10mg/1ml
  • 50mg/5ml

DIRECTION OF USE:

For I.V. use only – Must be diluted before

Must be diluted before use.

See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.

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

The vial stopper is not made with natural rubber latex.

Sterile, Nonpyrogenic, Preservative free.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Keep out of reach of children

STORAGE & DOSAGE:

Storage: Store the vials in the original cartons between 2°C to 8°C (36° F to 46° F)

Dosage: As directed by the Oncologist.

Why Taj Pharmaceuticals? 

Taj Pharmaceuticals is a reputable choice for Vinorelbine Injection USP, known for its pharmaceutical expertise and commitment to quality. With a strong presence in the pharmaceutical industry, Taj Pharmaceuticals brings a deep understanding of medications, including Vinorelbine Injection USP, to the table. This experience ensures that their product is of high quality and reliability, instilling confidence in healthcare providers and patients alike. One of Taj Pharmaceuticals’ standout attributes is its unwavering commitment to maintaining the highest standards of quality and safety in pharmaceutical products. Their manufacturing processes adhere to stringent quality control measures, ensuring the precise and consistent production of medications, including Vinorelbine Injection USP. This dedication to quality assurance is a hallmark of their reputation.

Taj Pharmaceuticals operates as an exporter from India, making essential medications like Vinorelbine Injection USP accessible to healthcare providers and patients globally. Their wide-reaching presence contributes to the enhancement of patient care on an international scale, as patients worldwide can benefit from their high-quality pharmaceutical offerings. Their advanced manufacturing facilities are equipped to meet the demands of producing vital medications like Vinorelbine Injection USP. These facilities play a pivotal role in delivering reliable and safe pharmaceuticals to healthcare institutions and patients globally. Taj Pharmaceuticals has earned trust within the medical community due to its consistent delivery of dependable pharmaceuticals. Their proven track record underscores their commitment to maintaining high standards of quality and safety in medical treatments. Above all, Taj Pharmaceuticals places patient well-being at the forefront of its mission. Their dedication to providing reliable medications like Vinorelbine Injection USP demonstrates a genuine commitment to improving patient outcomes and overall well-being. In addition, their flexibility in offering various formulations caters to the diverse needs and preferences of patients, making them a trusted pharmaceutical partner in healthcare.

What is Vinorelbine Injection USP and its uses?

Vinorelbine Injection USP is a medication that belongs to the class of drugs known as vinca alkaloids. It is used to treat certain types of cancer, specifically metastatic breast cancer and advanced non-small cell lung cancer. Here’s an overview of Vinorelbine Injection USP and its uses:

  • Medication Type: Vinorelbine is an antineoplastic agent, meaning it is used to treat cancer by interfering with the growth and spread of cancer cells.

Uses:

  • Metastatic Breast Cancer: Vinorelbine Injection USP is used as a treatment for metastatic breast cancer. It may be administered as a single agent or in combination with other medications, depending on the specific treatment plan developed by the healthcare provider.
  • Advanced Non-Small Cell Lung Cancer: Vinorelbine is also used to treat advanced non-small cell lung cancer, particularly when other treatments have not been effective or are not suitable for the patient.
  • Administration: Vinorelbine Injection USP is typically administered as an intravenous (IV) infusion, which means it is delivered directly into a vein. The dosage and schedule of administration are determined by the healthcare provider based on factors such as the patient’s overall health, cancer type, and response to treatment.
  • Mechanism of Action: Vinorelbine interferes with the process of cell division, a critical step in the growth and spread of cancer cells. It disrupts microtubule formation, which is essential for proper cell division. By inhibiting microtubules, vinylbine prevents cancer cells from dividing and multiplying, ultimately leading to their death.
  • Benefits: Vinorelbine Injection USP helps to shrink or slow down the growth of cancer tumors, thereby improving the patient’s quality of life and potentially extending survival in certain cases.
  • Duration of Treatment: The duration of vinylbine treatment can vary depending on the patient’s response to the medication, the specific cancer type, and the treatment plan developed by the healthcare provider.

How Does Vinorelbine Injection USP Work?

Vinorelbine Injection USP works by interfering with the process of cell division, a crucial step in the growth and spread of cancer cells. It belongs to a class of drugs known as vinca alkaloids, which have the following mechanism of action:

  • Microtubule Disruption: Inside a cell, microtubules are structural components that play a vital role in cell division. They form the mitotic spindle, which is responsible for segregating chromosomes during cell division. The proper functioning of microtubules is essential for cell division to occur correctly.
  • Inhibition of Microtubule Formation: Vinorelbine disrupts the formation and function of microtubules. It binds to the microtubules’ protein subunits, preventing them from assembling into the long, dynamic filaments required for normal cell division.
  • Blockage of Cell Division: By interfering with microtubules, vinylbine inhibits the proper formation of the mitotic spindle. This disruption prevents cancer cells from completing the process of cell division (mitosis) successfully.
  • Cell Cycle Arrest: The interference with microtubule dynamics causes cancer cells to become arrested or stuck in the cell cycle, specifically in the G2 and M phases. As a result, they cannot progress through the cell division process and cannot reproduce.
  • Cell Death: When cancer cells are unable to divide and multiply, they may undergo programmed cell death (apoptosis) or be targeted and destroyed by the body’s immune system.

Vinorelbine Injection USP’s primary mechanism of action is to disrupt the microtubules necessary for cancer cell division. By preventing proper cell division, the medication inhibits the growth and spread of cancer cells, ultimately leading to their death. This mechanism makes vinylbine an essential treatment option for specific types of cancer, including metastatic breast cancer and advanced non-small cell lung cancer, when other treatments have proven ineffective or unsuitable.

Benefits of Vinorelbine Injection USP:

  • Cancer Treatment: Vinorelbine Injection USP is used to treat certain types of cancer, including metastatic breast cancer and advanced non-small cell lung cancer. It can help shrink or slow down the growth of cancerous tumors.
  • Improved Quality of Life: By effectively targeting cancer cells, Vinorelbine can provide relief from cancer-related symptoms such as pain, shortness of breath, and fatigue. This can significantly improve a patient’s overall quality of life.
  • Treatment Options: Vinorelbine is often used when other cancer treatments have not been effective or are not suitable for the patient. It can offer an alternative or adjunct therapy to manage challenging cancer cases.
  • Extended Survival: In some cases, Vinorelbine treatment can extend the survival of patients with advanced cancer, providing them with more time to spend with loved ones and engage in meaningful activities.

Common Side Effects of Vinorelbine Injection USP:

  • Low Blood Cell Counts: Vinorelbine can lead to a decrease in the number of white blood cells (neutropenia), red blood cells (anemia), and platelets (thrombocytopenia). This may increase the risk of infections, fatigue, and bleeding.
  • Nausea and Vomiting: Nausea and vomiting are common side effects of vinylbine. Medications to prevent or manage these symptoms are often prescribed alongside Vinorelbine treatment.
  • Constipation: Some patients may experience constipation as a side effect. Maintaining a diet high in fiber and drinking plenty of fluids can help alleviate this symptom.
  • Peripheral Neuropathy: Vinorelbine can cause peripheral neuropathy, which is characterized by tingling, numbness, or weakness in the hands and feet. This side effect can be dose-limiting and may require dose adjustments or discontinuation of treatment.
  • Injection Site Reactions: Pain, redness, or swelling at the injection site is possible with vinylbine injection. These reactions are usually mild and temporary.
  • Hair Loss: Some patients may experience hair loss (alopecia) as a side effect of Vinorelbine treatment. Hair typically regrows after treatment ends.
  • Fatigue: Fatigue or weakness is a common side effect, although it tends to be less severe than with some other cancer treatments.
  • Allergic Reactions: While rare, allergic reactions to vinylbine are possible and require immediate medical attention. Signs may include rash, itching, swelling, severe dizziness, or difficulty breathing.

Frequently Asked Questions About Vinorelbine Injection USP?

Certainly, here are some frequently asked questions (FAQs) about Vinorelbine Injection USP:

  • What is Vinorelbine Injection USP used for?

Vinorelbine Injection USP is used to treat certain types of cancer, including metastatic breast cancer and advanced non-small cell lung cancer.

  • How is Vinorelbine Injection USP administered?

Vinorelbine Injection USP is typically administered as an intravenous (IV) infusion, meaning it is delivered directly into a vein. The specific dosage and schedule are determined by the healthcare provider based on the patient’s condition and response to treatment.

  • Are there alternatives to Vinorelbine for cancer treatment?

Yes, there are various treatment options for cancer, and the choice of therapy depends on the type and stage of cancer, as well as individual patient factors. Vinorelbine may be used when other treatments have not been effective or are not suitable for the patient.

  • What are the common side effects of Vinorelbine Injection USP?

Common side effects of Vinorelbine Injection USP may include low blood cell counts (neutropenia, anemia, thrombocytopenia), nausea, vomiting, constipation, peripheral neuropathy, injection site reactions, hair loss, fatigue, and more. These side effects vary in severity among individuals.

  • How is peripheral neuropathy managed during Vinorelbine treatment?

Peripheral neuropathy, characterized by tingling, numbness, or weakness in the hands and feet, is a potential side effect of Vinorelbine. Management strategies may include dose adjustments, symptom specific medications, and physical therapy to improve nerve function.

  • Can Vinorelbine Injection USP be used during pregnancy or breastfeeding?

Vinorelbine is generally not recommended during pregnancy or breastfeeding due to potential risks to the fetus or infant. Patients should discuss their pregnancy or breastfeeding status with their healthcare provider before starting treatment.

  • How often is Vinorelbine Injection administered?

The frequency of Vinorelbine administration varies depending on the specific treatment plan and the patient’s response. It may be given weekly or on a different schedule determined by the healthcare provider.

  • What should I do if I experience an allergic reaction to Vinorelbine Injection USP?

Allergic reactions to Vinorelbine are rare but possible. If you experience symptoms such as rash, itching, swelling, severe dizziness, or difficulty breathing, seek immediate medical attention.

  • Is Vinorelbine Injection USP effective in all types of cancer?

Vinorelbine is primarily used to treat specific types of cancer, including metastatic breast cancer and advanced non-small cell lung cancer. Its effectiveness may vary depending on the type and stage of cancer.

Patients should consult with their healthcare provider for personalized information and guidance regarding Vinorelbine Injection USP, as individual circumstances and medical guidelines may vary.

As Vinorelbine Injection USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Vinorelbine Injection USP 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, 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

Vinorelbine Injection USP 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 Vinorelbine Injection USP, 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. Vinorelbine Injection USP 10mg/ml (10mg/1ml, 50mg/5ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a. Vinorelbine Injection USP 10mg/ml (10mg/1ml, 50mg/5ml)
Each ml contains
Vinorelbine tartrate USP
Equivalent to Vinorelbine………….10mg
Water for Injection USP………………q.s.

THERAPEUTIC INDICATION:

Vinorelbine is used alone and in combination with other medications to treat non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body.

PACKING:

10mg/ml
1) 10mg/1ml
2) 50mg/5ml

DIRECTION OF USE:

For I.V. use only – Must be diluted before
Must be diluted before use.
See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
The vial stopper is not made with natural rubber latex.
Sterile, Nonpyrogenic, Preservative free.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children

STORAGE & DOSAGE:

Storage: Store the vials in the original cartons between 2°C to 8°C (36° F to 46° F)
Dosage: As directed by the Oncologist.