Paclitaxel Injection USP 6mg/ml (100mg/16.7ml) Technical Specification:      

Product Name:Paclitaxel Injection USP 6mg/ml (100mg/16.7ml)
Brand Name:Generics
Strength:6mg/ml (30mg/5ml, 100mg/16.7ml, 150mg/25ml, 260mg/43.3ml, 300mg/50ml)
Dosage Form:Liquid Injection
Packing:MULTI DOSE VIAL
Route of Administration:For I.V. Infusion after dilution
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 (with polyoxyethylated castor oil) is used along or along with other chemotherapy medications to treat breast cancer, ovarian cancer, and non-small cell lung cancer (NSCLC).
Storage:Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Paclitaxel Injection USP 6mg/ml (100mg/16.7ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Paclitaxel Injection USP 6mg/ml (100mg/16.7ml)
    Each ml contains:
    Paclitaxel USP……………………………6mg
    Polyoxyl 35 Castor oil USNF………527mg
    Anhydrous Citric Acid USP……….2mg
    Dehydrated alcohol USP…………..49.7%v/v

THERAPEUTIC INDICATION:

Paclitaxel (with polyoxyethylated castor oil) is used along or along with other chemotherapy medications to treat breast cancer, ovarian cancer, and non-small cell lung cancer (NSCLC).

PACKING:

6mg/ml

  • 30mg/5ml
  • 100mg/16.7ml
  • 150mg/25ml
  • 260mg/43.3ml
  • 300mg/50ml

DIRECTION OF USE:

For Intravenous Infusion after dilution.

See 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 dilution. 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.

CAUTION: Cytotoxic agent special Handling

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

NOTE: Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

IMPORTANT WARNING

Paclitaxel injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer. Paclitaxel injection may cause a large decrease in the number of white blood cells (a type of blood cell that is needed to fight infection) in your blood. This increases the risk that you will develop a serious infection. You should not receive paclitaxel if you already have a low number of white blood cells. Your doctor will order laboratory tests before and during your treatment to check the number of white blood cells in your blood.

Paclitaxel is given as an injection or infusion into the vein (intravenous, IV).

Paclitaxel is an irritant. An irritant is a chemical that can cause inflammation of the vein through which it is given. If the medication escapes from the vein it can cause tissue damage. If you experience pain or notice redness or swelling at the IV site while you are receiving Paclitaxel, alert your health care professional immediately.

Dilution Required Prior to Intravenous Infusion.

Wear gloves at all times when handling containers.

Retain in carton until time of use.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

When considering Taj Pharmaceuticals for Paclitaxel Injection USP or any medication, it’s crucial to conduct thorough research and consult with healthcare professionals. Taj Pharmaceuticals, based in India, is known for manufacturing and marketing a range of pharmaceutical products, including generic medications. First and foremost, you should ensure that the company adheres to good manufacturing practices (GMP) and complies with regulatory standards in your region. This guarantees the quality and safety of the medications they produce. Additionally, it’s important to verify the consistent availability of the medication you need, as disruptions in the supply chain can be concerning for patients and healthcare providers.

Cost is another significant factor to consider. Compare the pricing of Taj Pharmaceuticals’ medications with those from other reputable pharmaceutical companies. Generic medications are often more cost-effective than their brand-name counterparts, making affordability an important consideration. Reputation and reviews play a critical role in your decision-making process. Look for feedback from healthcare professionals and patients who have experience with the company’s products. A positive reputation is a reassuring indicator of reliability. Consider the accessibility of the company’s products in your area or through your healthcare provider. Distribution and availability should align with your needs. Furthermore, evaluate the level of customer support and assistance offered by the company in case you have questions or encounter issues with the medication. The choice of a pharmaceutical company should be based on a combination of factors, including product quality, price, and regulatory compliance. Always consult with your healthcare provider before starting or switching medications to ensure the most suitable treatment options for your specific medical condition. Keep in mind that pharmaceutical companies and their reputations may evolve over time, so stay informed with the latest information and recommendations from healthcare authorities and professionals.

What is Paclitaxel Injection USP and its uses:

Paclitaxel Injection USP is a medication that contains the active ingredient paclitaxel, which is a type of chemotherapy drug. Paclitaxel is derived from the bark of the Pacific yew tree and is used to treat various types of cancer. Here are some key points about Paclitaxel Injection USP and its uses:

  • Cancer Treatment: Paclitaxel is primarily used in the treatment of various types of cancer, including breast cancer, ovarian cancer, non-small cell lung cancer, and Kaposi’s sarcoma. It is often administered as part of a combination chemotherapy regimen or as a single-agent therapy, depending on the specific cancer and its stage.
  • Mechanism of Action: Paclitaxel works by disrupting the microtubule structures within cancer cells, preventing them from dividing and growing. This interference with cell division leads to cell death and slows down the progression of cancer.
  • Administration: Paclitaxel is typically administered through intravenous (IV) infusion in a healthcare setting, such as a hospital or clinic. The dosage and frequency of administration are determined by the patient’s specific cancer diagnosis and treatment plan.
  • Common Side Effects: The use of Paclitaxel Injection USP may cause various side effects, including nausea, vomiting, hair loss, fatigue, low blood cell counts (which can lead to an increased risk of infection), and peripheral neuropathy (numbness and tingling in the extremities). These side effects can vary in severity among patients.
  • Precautions and Monitoring: Patients receiving Paclitaxel require close monitoring by their healthcare providers to manage and minimize side effects. It’s essential to follow the prescribed treatment schedule and discuss any concerns or symptoms with the medical team.
  • Contraindications: Some individuals may not be suitable candidates for Paclitaxel treatment due to preexisting medical conditions or allergies. Your healthcare provider will assess your medical history to determine if this medication is appropriate for you.
  • Availability: Paclitaxel Injection USP is available by prescription only and should be administered by trained healthcare professionals experienced in chemotherapy administration.

It’s important to note that the use of Paclitaxel Injection USP is specific to cancer treatment and should be discussed thoroughly with an oncologist or healthcare provider. The decision to use this medication is based on an individual’s cancer diagnosis, stage, and overall health, as well as the potential benefits and risks associated with the treatment.

How Does Paclitaxel Injection USP Work?

Paclitaxel Injection USP, like other medications containing paclitaxel, works by disrupting the normal function of microtubules in cells. Microtubules are a critical component of the cell’s structural framework, called the cytoskeleton, and they play a crucial role in cell division (mitosis) and other cellular processes. Here’s how Paclitaxel Injection USP works:

  • Microtubule Stabilization: Paclitaxel binds to microtubules in the cell and stabilizes them. Normally, microtubules are dynamic structures that rapidly assemble and disassemble during cell division. However, paclitaxel prevents them from disassembling by binding to them and locking them in place.
  • Disruption of Cell Division: During cell division, microtubules form a spindle apparatus that helps separate the duplicated chromosomes into two daughter cells. Paclitaxel’s stabilization of microtubules interferes with this process. It prevents the microtubules from properly forming the spindle apparatus and segregating the chromosomes.
  • Cell Cycle Arrest: As a result of disrupted cell division, cells treated with paclitaxel become arrested or stuck in a phase of the cell cycle called the metaphase. In metaphase, the chromosomes are aligned in the center of the cell but cannot complete the division process. This arrest prevents the cancer cells from proliferating and dividing.
  • Apoptosis (Cell Death): Some cells may eventually undergo apoptosis, a process of programmed cell death. Paclitaxel-induced cell cycle arrest and damage to the microtubules can trigger signals within the cell that lead to apoptosis. This is a desirable outcome in cancer treatment because it results in the death of cancer cells.
  • Anti-Angiogenic Effects: Paclitaxel can also have anti-angiogenic effects, which means it interferes with the development of new blood vessels (angiogenesis) that tumors need to grow and spread. By inhibiting angiogenesis, paclitaxel can help deprive the tumor of nutrients and oxygen, further limiting its growth.

Overall, Paclitaxel Injection USP’s mechanism of action primarily involves disrupting microtubules in cancer cells, which hinders cell division and can lead to cell death. This targeted interference with the cell cycle and structural integrity of cancer cells makes paclitaxel an effective chemotherapy agent for treating various types of cancer. However, it’s important to note that this treatment can also affect healthy cells, leading to side effects, which is why its use is closely monitored and carefully managed by healthcare professionals during cancer treatment.

Benefits of Paclitaxel Injection USP:

  • Effective Cancer Treatment: Paclitaxel is used to treat several types of cancer, including breast cancer, ovarian cancer, non-small cell lung cancer, and Kaposi’s sarcoma. It can be a vital component of cancer treatment plans, especially when combined with other chemotherapy agents.
  • Tumor Shrinkage: One of the primary benefits of paclitaxel is its ability to shrink tumors. This can help alleviate symptoms associated with cancer, such as pain, pressure on organs or nerves, and difficulty breathing.
  • Reduced Cancer Spread: Paclitaxel can help prevent cancer from spreading to other parts of the body. This is particularly important in controlling the progression of cancer and improving overall survival rates.
  • Potential for Curative Intent: In some cases, paclitaxel can be part of a curative treatment plan, leading to the complete eradication of cancer.

Side Effects of Paclitaxel Injection USP:

  • Nausea and Vomiting: Nausea and vomiting are common side effects of paclitaxel treatment. Medications can be prescribed to help manage these symptoms.
  • Hair Loss: Many patients experience hair loss (alopecia) while undergoing paclitaxel treatment. This is usually temporary, and hair typically starts to regrow after treatment ends.
  • Low Blood Cell Counts: Paclitaxel can affect blood cell production in the bone marrow, leading to low white blood cell counts (neutropenia), low red blood cell counts (anemia), and low platelet counts (thrombocytopenia). This can increase the risk of infections, fatigue, and bleeding.
  • Peripheral Neuropathy: Some individuals may develop peripheral neuropathy, which causes numbness, tingling, or pain in the hands and feet. This can be temporary or persistent.
  • Allergic Reactions: While rare, allergic reactions to paclitaxel can occur and may include symptoms such as difficulty breathing, rash, itching, and swelling. These require immediate medical attention.
  • Joint and Muscle Pain: Paclitaxel treatment can sometimes cause joint and muscle pain, which may be managed with pain relievers.
  • Gastrointestinal Issues: Diarrhea and mouth sores can also occur as side effects of paclitaxel treatment.
  • Fatigue: Cancer-related fatigue is common and can be exacerbated by paclitaxel treatment.

It’s important to emphasize that healthcare providers closely monitor patients receiving paclitaxel to manage and mitigate side effects. They may adjust the treatment regimen or provide supportive care to minimize discomfort. The benefits of paclitaxel in treating cancer often outweigh the potential side effects, but the decision to use this medication should be made in consultation with a healthcare professional who can assess the individual’s specific situation and treatment goals.

Frequently Asked Questions About Paclitaxel Injection USP:

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

  • What is Paclitaxel Injection USP used for?

Paclitaxel Injection USP is used for the treatment of various types of cancer, including breast cancer, ovarian cancer, nonsmall cell lung cancer, and Kaposi’s sarcoma.

  • How does Paclitaxel Injection USP work?

Paclitaxel works by stabilizing microtubules in cells, disrupting cell division, and preventing cancer cells from growing and dividing. This ultimately leads to cell death and the reduction of tumor size.

  • How is Paclitaxel Injection USP administered?

Paclitaxel Injection USP is typically administered through intravenous (IV) infusion in a healthcare setting, such as a hospital or clinic. The dosage and schedule are determined by the specific cancer being treated and the patient’s condition.

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

Common side effects include nausea, vomiting, hair loss (alopecia), fatigue, low blood cell counts (neutropenia, anemia, thrombocytopenia), peripheral neuropathy (tingling or numbness in the hands and feet), joint and muscle pain, diarrhea, and mouth sores.

  • Is Paclitaxel Injection USP a curative treatment for cancer?

Paclitaxel can be part of a treatment plan aimed at curing cancer, but its effectiveness depends on the type and stage of cancer. It is often used in combination with other chemotherapy drugs or therapies.

  • How long does Paclitaxel treatment typically last?

The duration of Paclitaxel treatment varies depending on the specific cancer and treatment plan. Some patients may receive it for a few months, while others may have longer treatment regimens.

  • Can Paclitaxel cause allergic reactions?

While rare, some individuals may experience allergic reactions to Paclitaxel, which can include difficulty breathing, rash, itching, and swelling. Patients are closely monitored during infusion to detect and manage such reactions.

  • Does Paclitaxel affect blood cell counts?

Yes, Paclitaxel can lead to low blood cell counts, including low white blood cell counts (neutropenia), low red blood cell counts (anemia), and low platelet counts (thrombocytopenia). This can increase the risk of infection, fatigue, and bleeding.

  • Is hair loss from Paclitaxel permanent?

Hair loss (alopecia) caused by Paclitaxel treatment is usually temporary. Hair typically begins to regrow after treatment ends.

  • Can I continue with my daily activities while receiving Paclitaxel treatment?

The ability to continue daily activities can vary depending on how a patient responds to treatment and the side effects experienced. Some people may be able to maintain normal activities, while others may need to adjust their routines based on their condition.

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

Paclitaxel 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 Paclitaxel 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:

Paclitaxel Injection USP 6mg/ml (30mg/5ml, 100mg/16.7ml, 150mg/25ml, 260mg/43.3ml, 300mg/50ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Paclitaxel Injection USP 6mg/ml (30mg/5ml, 100mg/16.7ml, 150mg/25ml, 260mg/43.3ml, 300mg/50ml)
Each ml contains:
Paclitaxel USP……………………………6mg
Polyoxyl 35 Castor oil USNF………527mg
Anhydrous Citric Acid USP……….2mg
Dehydrated alcohol USP…………..49.7%v/v

THERAPEUTIC INDICATIONS:

Paclitaxel (with polyoxyethylated castor oil) is used along or along with other chemotherapy medications to treat breast cancer, ovarian cancer, and non-small cell lung cancer (NSCLC).

PACKING:

6mg/ml
1) 30mg/5ml
2) 100mg/16.7ml
3) 150mg/25ml
4) 260mg/43.3ml
5) 300mg/50ml

DIRECTION OF USE:

For Intravenous Infusion after dilution.
See insert for detailed dosage, directions for use and precautions.

CAUTION AND WARNING:

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

CAUTION: Cytotoxic agent special Handling

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

NOTE: Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

IMPORTANT WARNING Paclitaxel injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer. Paclitaxel injection may cause a large decrease in the number of white blood cells (a type of blood cell that is needed to fight infection) in your blood. This increases the risk that you will develop a serious infection. You should not receive paclitaxel if you already have a low number of white blood cells. Your doctor will order laboratory tests before and during your treatment to check the number of white blood cells in your blood.

Paclitaxel is given as an injection or infusion into the vein (intravenous, IV).
Paclitaxel is an irritant. An irritant is a chemical that can cause inflammation of the vein through which it is given. If the medication escapes from the vein it can cause tissue damage. If you experience pain or notice redness or swelling at the IV site while you are receiving Paclitaxel, alert your health care professional immediately.

Dilution Required Prior to Intravenous Infusion.
Wear gloves at all times when handling containers.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep medicine out of reach of children.

STORAGE AND DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature].
Protect from light.
Dosage: As directed by the Physician.