Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent (Apidryl) Technical Specification: 

Product Name:Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
Brand Name:Apidryl
Strength:40mg/ml (20mg/0.5ml, 80mg/2 ml, 120mg/3ml)
Dosage Form:Liquid Injection – Combi pack
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: Docetaxel is a chemotherapy medication used to treat a number of types of cancer. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer. It may be used by itself or along with other chemotherapy medication.
Storage:Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent 

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent 
    Each combi pack contains
    One vial of Docetaxel Injection USP 120mg/3ml
    Each sterile vial contains
    Docetaxel Trihydrate USP
    Equivalent to Docetaxel Anhydrous……………120mg
    Anhydrous Citric Acid USP………………………….16.5mg
    Polysorbate 80 USNF………………………………….3096mg
    Accompanying with one vial of solvent for Docetaxel Injection 80mg
    Each sterile vial contains
    Alcohol USP…………………………1170mg
    Water for Injection USP……….q.s. to 9.0ml

THERAPEUTIC INDICATION:

Docetaxel is a chemotherapy medication used to treat a number of types of cancer. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer. It may be used by itself or along with other chemotherapy medication.

PACKING:

40mg/ml

  • 20mg/0.5ml
  • 80mg/2 ml
  • 120mg/3ml

DIRECTION OF USE:

For I.V. use only

Reconstitution for 120mg/3ml: Reconstitute using Solvent for Docetaxel Injection Concentrate 120mg. Rotate the vial gently and allow the premix to stand for 5 minutes. Use this Docetaxel Premix for further dilution. Use immediately after reconstitution.

See package insert for complete prescribing information.

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/ Institution.
CAUTION: Cytotoxic Agent – Special Handling.
Instructions: Solvent for Docetaxel Concentrate USP to be used as diluent and not to be injected as such.
Retain in original package to protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.

Why Taj Pharmaceuticals?

Elevate your healthcare journey with Taj Pharmaceuticals and experience the excellence of Docetaxel Injection. At Taj Pharmaceuticals, we prioritize your health above all else, and our unwavering commitment to quality ensures that you receive the safest and most effective treatment possible. Our dedication to extensive research and development sets us apart. We have invested years in refining and perfecting Docetaxel Injection, a crucial therapy in the fight against cancer. Our state-of-the-art facilities and a team of experienced professionals work tirelessly to ensure that every vial of Docetaxel meets the highest standards of quality and efficacy. When you choose Taj Pharmaceuticals for Docetaxel Injection, you’re not just choosing a medication; you’re choosing a partner in your battle against cancer. We understand the physical and emotional challenges that come with this journey, and we stand by your side, providing support and resources every step of the way. Our commitment to patient well-being extends beyond the product itself. We offer comprehensive information, guidance, and assistance to both healthcare providers and patients, empowering them to make informed decisions about their treatment. Taj Pharmaceuticals is not just a pharmaceutical company; we are a source of hope and healing. Make the choice that countless healthcare professionals and patients trust. Choose Taj Pharmaceuticals for Docetaxel Injection and take a significant step toward a healthier, brighter future. Your well-being is our priority, and together, we can make a difference in the fight against cancer.

What is Docetaxel Injection and its uses?

Docetaxel Injection is a vital medication used in the treatment of various types of cancer. This chemotherapy drug, classified as a taxane, plays a crucial role in combating cancer’s growth and spread. One of its primary applications is in breast cancer treatment, where it can be employed alone or in combination with other chemotherapy agents for both early-stage and advanced cases. In addition to breast cancer, Docetaxel is a valuable asset in addressing non-small cell lung cancer (NSCLC), a prevalent form of lung cancer. It is often integrated into combination therapies to effectively combat this disease. Furthermore, Docetaxel finds utility in advanced prostate cancer cases, offering relief when hormone therapy is no longer effective. Gastric cancer treatment may also involve Docetaxel, often as part of a multidrug approach to manage cancer that has metastasized. It extends its utility to head and neck cancer treatment, especially when other treatment modalities have proven inadequate. Additionally, ovarian cancer patients benefit from Docetaxel as part of their comprehensive treatment regimen, usually in combination with other chemotherapy drugs. This versatile medication can also be deployed in the treatment of other cancers like esophageal cancer, bladder cancer, and soft tissue sarcoma, demonstrating its wide-reaching impact in the field of oncology. Docetaxel is typically administered through intravenous infusion by healthcare professionals. However, patients should be aware that it may carry potential side effects, and its specific usage and dosage will depend on the individual’s cancer type, stage, and overall health. Thus, it is crucial for patients to engage in thorough discussions with their healthcare providers to make well-informed decisions about their treatment plans.

How does Docetaxel Injection Work?

Docetaxel Injection operates as a potent cancer-fighting medication by disrupting the fundamental processes of cancer cell growth and division. Classified as a taxane, this drug is specifically engineered to target and interfere with microtubules within cells, thereby thwarting the proliferation of cancer cells. Within a cell, microtubules serve as essential structural elements, particularly during the process of cell division. They aid in segregating chromosomes, ensuring that each new cell inherits a complete set of genetic material. Docetaxel, however, disrupts this critical function. It stabilizes microtubules, preventing their usual disassembly and reassembly during cell division. Consequently, microtubules become immobilized, rendering them unable to carry out their intended role.

The consequence of this interference is a significant disruption in the cancer cell’s ability to divide and replicate. The stable microtubules created by Docetaxel halt the uncontrolled growth and spread of cancer cells, effectively putting a brake on the progression of the disease. Ultimately, the cancer cells undergo programmed cell death, a process known as apoptosis. In essence, Docetaxel’s mechanism of action serves as a powerful tool to impede the relentless growth of cancer, reduce tumor size, and curtail the disease’s advance. However, it’s essential to recognize that while it targets cancer cells, it can also affect some healthy cells, leading to potential side effects. Healthcare providers carefully manage these side effects to ensure the overall well-being of patients undergoing treatment.

Benefits of Docetaxel Injection:

Docetaxel Injection offers a range of significant benefits in the treatment of various cancers. Firstly, it stands out as an effective cancer-fighting tool, effectively shrinking tumors and slowing the progression of the disease. Additionally, it finds utility in adjuvant therapy, where it’s administered post-surgery or after primary treatments to lower the risk of cancer recurrence. This adjuvant use can be pivotal in preventing the return of cancer cells and bolstering long-term outcomes.

Combination therapy is another strength of Docetaxel. When used in conjunction with other chemotherapy drugs or treatments, its efficacy in combating cancer is often enhanced, offering tailored solutions for specific cancer types and stages. For advanced cancer patients, Docetaxel extends its support by providing palliative care. By alleviating symptoms and improving the quality of life, it helps manage pain and discomfort associated with late-stage cancer, providing much-needed relief and comfort.

Side Effects of Docetaxel Injection:

Despite its benefits, Docetaxel can lead to certain side effects that require careful consideration. Common side effects encompass symptoms like nausea, vomiting, diarrhea, and fatigue, typically manageable with medications and lifestyle adjustments. Another notable concern is the potential for reduced blood cell counts, which can elevate the risk of infection, anemia, and bleeding. Regular blood tests are performed to closely monitor these levels during treatment.

Neuropathy, characterized by numbness, tingling, or weakness in the extremities, is another side effect that some individuals may experience. This side effect can be dose-dependent and may ameliorate post-treatment. Additionally, hair loss or thinning is a common but generally temporary side effect, with hair often regrowing after treatment cessation. Severe allergic reactions to Docetaxel are rare but demand immediate medical attention, manifesting as difficulty breathing, facial or throat swelling, and hives. Fluid retention leading to swelling in the extremities is another potential side effect, typically managed through medication and dietary adjustments. Nail changes, such as alterations in color or texture, may also occur but are typically reversible post-treatment.

In conclusion, the benefits of Docetaxel Injection in cancer treatment are substantial, encompassing effective tumor reduction, adjuvant therapy, combination treatment options, and palliative care. Nevertheless, patients and healthcare providers must be aware of potential side effects, which can vary in severity from person to person. Monitoring and management strategies are employed to ensure the best possible treatment experience, with the understanding that the decision to use Docetaxel is made on an individualized basis, weighing the potential benefits against the risks of side effects. Patients are encouraged to openly discuss any concerns with their healthcare team to make informed treatment decisions.

Frequently Asked Questions About Docetaxel Injection:

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

  1. What is Docetaxel Injection, and how does it work?

Docetaxel Injection is a chemotherapy medication used to treat various types of cancer. It works by disrupting the growth and division of cancer cells by stabilizing microtubules within the cells.

  1. What types of cancer is Docetaxel used to treat?

Docetaxel is used to treat breast cancer, lung cancer (no small cell lung cancer), prostate cancer, gastric (stomach) cancer, head and neck cancer, ovarian cancer, and other cancer types.

  1. Is Docetaxel used as a standalone treatment or in combination with other medications?

Docetaxel can be used both as a standalone treatment and in combination with other chemotherapy drugs, depending on the specific type and stage of cancer being treated.

  1. How is Docetaxel administered?

Docetaxel is typically administered through intravenous (IV) infusion by a healthcare professional. The dosage and schedule depend on the patient’s condition and the specific treatment plan.

  1. What are the potential side effects of Docetaxel?

Common side effects include nausea, vomiting, diarrhea, fatigue, hair loss, and low blood cell counts. Less common but more severe side effects can include neuropathy, allergic reactions, and fluid retention. Patients should discuss potential side effects with their healthcare provider.

  1. Is hair loss permanent with Docetaxel treatment?

Hair loss or thinning is a common side effect of Docetaxel, but it is usually temporary. Hair often regrows after the completion of treatment.

  1. How often is Docetaxel treatment administered?

The frequency of Docetaxel treatment depends on the specific cancer and treatment plan. It can be given every 3 weeks or on a different schedule determined by the healthcare provider.

  1. Can Docetaxel be used in palliative care?

Yes, Docetaxel is often used in palliative care for patients with advanced cancer. It can help alleviate symptoms, improve the quality of life, and extend survival.

  1. Are there any special precautions or considerations during Docetaxel treatment?

Patients receiving Docetaxel should be closely monitored for side effects, and blood cell counts should be checked regularly. Patients should inform their healthcare provider about any other medications they are taking to avoid potential interactions.

  1. Is Docetaxel safe during pregnancy or breastfeeding?

Docetaxel is not safe during pregnancy, and women of childbearing age should use effective contraception during treatment. It is not recommended while breastfeeding, as it may pass into breast milk and harm the infant.

These FAQs provide a basic understanding of Docetaxel Injection, but individual patient circumstances and treatment plans may vary. It’s important for patients to discuss their specific situation and any questions with their healthcare provider to make informed decisions about their treatment.

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

Docetaxel Injection 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 Docetaxel 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) Docetaxel Injection USP 40mg/ml (20mg/0.5ml) With Solvent
b) Docetaxel Injection USP 40mg/ml (80mg/2 ml) With Solvent
c) Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Docetaxel Injection USP 40mg/ml (20mg/0.5ml) With Solvent
Each combi pack contains
One vial of Docetaxel Injection USP 20mg/0.5ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………20mg
Anhydrous Citric Acid USP………………………….2.75mg
Polysorbate 80 USNF………………………………….516mg
Accompanying with one vial of solvent for Docetaxel Injection 20mg
Each sterile vial contains
Alcohol USP……………………...…195mg
Water for Injection USP……....q.s. to 1.5ml

b) Docetaxel Injection USP 40mg/ml (80mg/2ml) With Solvent
Each combi pack contains
One vial of Docetaxel Injection USP 80mg/2ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………80mg
Anhydrous Citric Acid USP………………………….11mg
Polysorbate 80 USNF………………………………….2064mg
Accompanying with one vial of solvent for Docetaxel Injection 80mg
Each sterile vial contains
Alcohol USP……………………...…780mg
Water for Injection USP……....q.s. to 6.0ml

d) Docetaxel Injection USP 40mg/ml (120mg/3ml) With Solvent
Each combi pack contains
One vial of Docetaxel Injection USP 120mg/3ml
Each sterile vial contains
Docetaxel Trihydrate USP
Equivalent to Docetaxel Anhydrous……………120mg
Anhydrous Citric Acid USP………………………….16.5mg
Polysorbate 80 USNF………………………………….3096mg
Accompanying with one vial of solvent for Docetaxel Injection 80mg
Each sterile vial contains
Alcohol USP……………………...…1170mg
Water for Injection USP……....q.s. to 9.0ml


THERAPEUTIC INDICATION:

Docetaxel is a chemotherapy medication used to treat a number of types of cancer. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer. It may be used by itself or along with other chemotherapy medication.

PACKING:

40mg/ml
1) 20mg/0.5ml
2) 80mg/2 ml
3) 120mg/3ml

DIRECTION OF USE:

For I.V. use only
Reconstitution for 120mg/3ml: Reconstitute using Solvent for Docetaxel Injection Concentrate 120mg. Rotate the vial gently and allow the premix to stand for 5 minutes. Use this Docetaxel Premix for further dilution. Use immediately after reconstitution.
See package insert for complete prescribing information.

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/ Institution.
CAUTION: Cytotoxic Agent – Special Handling.
Instructions: Solvent for Docetaxel Concentrate USP to be used as diluent and not to be injected as such.
Retain in original package to protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.