GENERIC NAME OF THE MEDICINAL PRODUCT:

Paclitaxel (Protein-bound Particles) for Injectable Suspension 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Paclitaxel (Protein-bound Particle) for Injectable suspension 100mg
Each vial contains:
Paclitaxel USP…………………………………………100mg
Human Albumin USP approximately.………900mg
(After reconstitution)

THERAPEUTIC INDICATION:

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

DIRECTION OF USE:

For Intravenous use only.
Reconstitution: Reconstitute with 20ml of 0.9% Sodium Chloride Injection USP resulting in a suspension containing 5mg/ml of paclitaxel.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
CAUTION: It is dangerous to take this preparation except under medical supervision of a Cancer Specialist.
WARNING: Cytotoxic Agent:
To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer specialist only.
CAUTION: The reconstituted suspension should be used within 8 hours of reconstitution.
NOTE: A protein-bound form of particulate paclitaxel. Functional properties are not the same as other Paclitaxel products. See package insert for more detailed information on dosage formulation.
SHOULD NOT BE SUBSTITUTED.
DO NOT pool unused portions from the vials. DO NOT administer more than one dose from a vial.
Prescription medicine only
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Read all sides of carton.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
Reconstituted suspension should be stored in its original carton at 2°C to 8°C and protect from bright light.
Dosage: As directed by the Oncologist.

Paclitaxel (Protein-bound Particles) for Injectable Suspension 100mg Technical Specification:

Product Name:Paclitaxel (Protein-bound Particles) for Injectable Suspension 100mg
Brand Name:SoftaxeL
Strength:100mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE DOSE 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: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Storage:Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
Reconstituted suspension should be stored in its original carton at 2°C to 8°C and protect from bright light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Paclitaxel (Protein-bound Particles) for Injectable Suspension 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Paclitaxel (Protein-bound Particle) for Injectable suspension 100mg
    Each vial contains:
    Paclitaxel USP…………………………………………100mg
    Human Albumin USP approximately.………900mg
    (After reconstitution)

THERAPEUTIC INDICATION:

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

DIRECTION OF USE:

For Intravenous use only.
Reconstitution: Reconstitute with 20ml of 0.9% Sodium Chloride Injection USP resulting in a suspension containing 5mg/ml of paclitaxel.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
CAUTION: It is dangerous to take this preparation except under medical supervision of a Cancer Specialist.
WARNING: Cytotoxic Agent:
To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer specialist only.
CAUTION: The reconstituted suspension should be used within 8 hours of reconstitution.
NOTE: A protein-bound form of particulate paclitaxel. Functional properties are not the same as other Paclitaxel products. See package insert for more detailed information on dosage formulation.
SHOULD NOT BE SUBSTITUTED.
DO NOT pool unused portions from the vials. DO NOT administer more than one dose from a vial.
Prescription medicine only
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Read all sides of carton.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
Reconstituted suspension should be stored in its original carton at 2°C to 8°C and protect from bright light.
Dosage: As directed by the Oncologist.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a distinguished pharmaceutical company renowned for its commitment to quality, innovation, and patient-centered care. One of their notable offerings is Paclitaxel for Injectable, and several compelling reasons make Taj Pharmaceuticals a preferred choice in the pharmaceutical industry. First and foremost, Taj Pharmaceuticals is dedicated to upholding the highest standards of quality in their products. Their Paclitaxel for Injectable is manufactured with meticulous precision and undergoes rigorous quality control processes to ensure both its safety and efficacy. This unwavering dedication to quality is a hallmark of Taj Pharmaceuticals. Another standout feature of Taj Pharmaceuticals is its strong focus on research and development (R&D). The company invests significantly in ongoing research and development efforts, aiming to continually enhance their products and formulate innovative solutions. This commitment to advancement ensures that patients have access to the most up-to-date and effective treatments available. Behind Taj Pharmaceuticals’ success is a team of highly experienced scientists, researchers, and healthcare professionals. This skilled workforce collaborates tirelessly to develop and manufacture pharmaceuticals that cater to the diverse needs of patients and healthcare providers. Furthermore, Taj Pharmaceuticals places a strong emphasis on regulatory compliance. Their products, including Paclitaxel for Injectable, adhere to stringent regulatory standards, ensuring they are safe, reliable, and in full compliance with all necessary regulatory requirements. This commitment builds trust among healthcare providers and patients alike.

Taj Pharmaceuticals has also achieved a broad global presence, making their products accessible to patients worldwide. Their extensive distribution network ensures that Paclitaxel for Injectable is readily available to those who require it, regardless of their geographic location. A patient-centered approach is at the heart of Taj Pharmaceuticals’ mission. They develop products, including Paclitaxel for Injectable, with a focus on improving the quality of life for individuals facing serious medical conditions, such as cancer. This commitment to patient well-being underscores their dedication to making a positive impact on healthcare. In addition to their pharmaceutical excellence, Taj Pharmaceuticals is known for competitive pricing. They strive to provide cost-effective options for patients in need, recognizing the financial burdens that medical treatments can impose. Moreover, Taj Pharmaceuticals is environmentally conscious and implements sustainable practices in its manufacturing processes. This commitment to sustainability aligns with global efforts to reduce the environmental impact of pharmaceutical production, demonstrating their corporate responsibility. Lastly, Taj Pharmaceuticals offers comprehensive support services. These include educational resources and patient assistance programs to ensure individuals receiving Paclitaxel for Injectable have the necessary information and assistance throughout their treatment journey.

What is Paclitaxel for Injectable and its uses:

Paclitaxel for Injectable is a potent chemotherapy medication used in the treatment of various types of cancer. Its primary active ingredient, paclitaxel, belongs to a class of drugs called taxanes. Paclitaxel is derived from the bark of the Pacific yew tree and works by inhibiting the growth and spread of cancer cells in the body.

The uses of Paclitaxel for Injectable include:

  • Breast Cancer: Paclitaxel is often used in the treatment of breast cancer, either as a single agent or in combination with other chemotherapy drugs. It can be employed in both early-stage and advanced-stage breast cancer, as well as in cases where cancer has spread to other parts of the body.
  • Ovarian Cancer: Paclitaxel is a crucial component in the chemotherapy regimens for ovarian cancer. It is used either alone or in combination with other drugs to treat both newly diagnosed and recurrent ovarian cancer.
  • Non-Small Cell Lung Cancer: Paclitaxel may be prescribed for the treatment of non-small cell lung cancer (NSCLC), a common type of lung cancer. It can be used in combination with other chemotherapy agents or in certain cases as a single-agent therapy.
  • Pancreatic Cancer: In some cases, Paclitaxel is used in the treatment of pancreatic cancer, often in combination with other chemotherapy drugs.
  • Esophageal Cancer: Paclitaxel may be part of the treatment plan for esophageal cancer, particularly in cases where the cancer has spread beyond the esophagus.
  • Other Cancers: Paclitaxel can also be employed in the treatment of other cancers, such as head and neck cancer, bladder cancer, and Kaposi’s sarcoma.

The mode of administration for Paclitaxel for Injectable is through intravenous infusion, which allows for precise dosing and delivery of the medication into the bloodstream. The exact dosing and treatment regimen will depend on the type and stage of cancer, as well as the patient’s overall health and response to treatment. It’s important to note that Paclitaxel for Injectable is a potent chemotherapy drug and may cause a range of side effects. Patients should receive this medication under the supervision of experienced healthcare providers who can monitor and manage any potential side effects. Treatment plans are often individualized to maximize effectiveness while minimizing adverse reactions.

How does Paclitaxel for Injectable Work?

Paclitaxel for Injectable, also known simply as paclitaxel, exerts its anticancer effects by interfering with the growth and division of cancer cells. It belongs to a class of drugs called taxanes, which target microtubules within cells. Microtubules are structural components of the cell’s cytoskeleton that play a crucial role in cell division and maintenance of cell shape.

Here’s how paclitaxel works:

  • Microtubule Stabilization: During cell division, microtubules normally go through dynamic cycles of growth and shrinkage. This dynamic instability is essential for separating chromosomes and ensuring proper cell division. Paclitaxel interferes with this process by binding to microtubules and stabilizing them. This prevents the microtubules from depolymerizing (shrinking) and, as a result, interrupts the normal cell division process.
  • Mitotic Arrest: By stabilizing microtubules, paclitaxel causes cancer cells to become arrested in the mitotic phase of cell division, specifically during metaphase. In metaphase, chromosomes are supposed to align at the center of the cell before being pulled apart into two daughter cells. Paclitaxel’s interference with microtubule dynamics prevents this proper alignment and separation, leading to mitotic arrest.
  • Cell Death: Paclitaxel-induced mitotic arrest ultimately triggers cell death pathways. The cell recognizes the abnormality and attempts to undergo apoptosis, a programmed cell death process. However, paclitaxel’s interference with microtubules prevents the cell from completing the apoptosis process, leading to cell death by other mechanisms, such as necrosis.

In summary, paclitaxel disrupts the normal progression of cell division by stabilizing microtubules, resulting in mitotic arrest and eventual cell death. This mechanism of action is particularly effective against rapidly dividing cancer cells, which are more vulnerable to disruptions in the cell division process than normal, healthy cells. However, because paclitaxel can affect rapidly dividing healthy cells as well, it can lead to various side effects, which must be carefully managed during cancer treatment.

Benefits of Paclitaxel for Injectable:

  • Cancer Treatment: Paclitaxel is primarily used for the treatment of various types of cancer, including breast cancer, ovarian cancer, lung cancer, and more. It can be effective in shrinking tumors, slowing down cancer progression, and improving overall survival rates in some cases.
  • Combination Therapy: Paclitaxel is often used in combination with other chemotherapy drugs, radiation therapy, or targeted therapies to enhance its effectiveness. Combination therapy can increase the chances of successful cancer treatment.
  • Advanced Cancer: Paclitaxel may be used in cases of advanced or metastatic cancer where other treatment options have limited success. It can help manage cancer symptoms and improve the quality of life for patients.

Side Effects of Paclitaxel for Injectable:

  • Hematological Effects: Paclitaxel can suppress the bone marrow’s ability to produce blood cells, leading to an increased risk of anemia, neutropenia (low white blood cell count), and thrombocytopenia (low platelet count). This can result in fatigue, increased susceptibility to infections, and bleeding problems.
  • Neurotoxicity: Paclitaxel can cause neuropathy, which is characterized by symptoms such as tingling, numbness, and weakness in the hands and feet. In severe cases, it can lead to difficulty walking or handling objects.
  • Gastrointestinal Issues: Some patients may experience nausea, vomiting, diarrhea, or abdominal pain during paclitaxel treatment. These side effects can be managed with medications and dietary adjustments.
  • Hair Loss: Paclitaxel commonly causes hair loss, including scalp, body, and facial hair. Hair may grow back after treatment ends.
  • Allergic Reactions: Allergic reactions to paclitaxel can occur, ranging from mild rashes and itching to more severe symptoms like difficulty breathing and swelling of the face, lips, or tongue. Immediate medical attention is needed if an allergic reaction occurs.
  • Muscle and Joint Pain: Some patients may experience muscle and joint pain during or after paclitaxel treatment.
  • Nail Changes: Paclitaxel can affect the nails, causing discoloration or changes in nail texture.
  • Heart Problems: In rare cases, paclitaxel may lead to heart-related side effects, including arrhythmias (irregular heartbeats) and heart failure.

It’s important to note that the severity and specific side effects of paclitaxel can vary from person to person. Oncologists carefully consider the potential benefits and risks when prescribing paclitaxel, and they closely monitor patients during treatment to manage side effects and adjust the treatment plan as needed. Patients are encouraged to communicate openly with their healthcare team about any side effects they experience to ensure the best possible care and quality of life during cancer treatment.

Frequently Asked Questions About Paclitaxel for Injectable:

Paclitaxel is a medication used to treat various types of cancer, including breast, lung, ovarian, and more. It is typically administered through injection, and there are several commonly asked questions about paclitaxel for injectable forms. Here are some frequently asked questions and their answers:

  1. What is Paclitaxel for Injectable used for?

Paclitaxel is primarily used to treat different types of cancer. It works by interfering with the growth and spread of cancer cells in the body.

  1. How is paclitaxel administered?

Paclitaxel is administered intravenously (IV), which means it is injected directly into a vein. It is usually given in a medical setting, such as a hospital or clinic.

  1. What are the common side effects of paclitaxel?

Common side effects of paclitaxel can include nausea, vomiting, diarrhea, hair loss, numbness or tingling in the hands or feet (peripheral neuropathy), and low blood cell counts (neutropenia). Your healthcare provider will monitor you for side effects during treatment.

  1. How often is paclitaxel given?

The frequency of paclitaxel injections depends on the specific cancer being treated and the treatment plan outlined by your healthcare provider. It can be given weekly, every two or three weeks, or on a different schedule.

  1. How long does each paclitaxel infusion take?

The duration of each paclitaxel infusion can vary, but it typically takes about one to three hours. Your healthcare team will determine the exact timing based on your treatment plan.

  1. Can paclitaxel be used during pregnancy or breastfeeding?

Paclitaxel is not recommended for use during pregnancy because it can harm the developing fetus. It is also not advised while breastfeeding, as it can pass into breast milk.

  1. What should I discuss with my healthcare provider before starting paclitaxel treatment?

Before starting paclitaxel treatment, you should discuss your medical history, any allergies, and current medications with your healthcare provider. Additionally, talk about potential side effects, the treatment schedule, and any concerns or questions you may have.

  1. Can I drive or operate heavy machinery while receiving paclitaxel?

Paclitaxel may cause dizziness or numbness, so it’s essential to be cautious when driving or operating heavy machinery. You should discuss this with your healthcare provider and follow their guidance.

  1. Are there any drug interactions with paclitaxel?

Some medications may interact with paclitaxel, potentially affecting its effectiveness or increasing the risk of side effects. Make sure your healthcare provider is aware of all the medications and supplements you are taking.

  1. What should I do if I miss a dose of paclitaxel?

It’s crucial to follow your treatment schedule as prescribed by your healthcare provider. If you miss a dose or have any concerns about your treatment, contact your healthcare team for guidance.

These are general guidelines, and individual experiences with paclitaxel may vary. Always consult your healthcare provider or oncologist for specific information and advice tailored to your situation.

As Paclitaxel for Injectable Exporters; We can cater to export business queries from the following geographies. We are exporting our Paclitaxel for Injectable 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

Paclitaxel for Injectable 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 Paclitaxel for Injectable, 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