GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 150mg
B. Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 440mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 150mg
Composition:
Each lyophilized vial contains:
Trastuzumab……………………...150mg
Excipients:
L-Histidine Hydrochloride
Monohydrate EP……………….3.36mg
L- Histidine U.S.P ……………...2.16mg
α, α-Trehalose
dihydrate NF…………………….136.2mg
Polysorbate 20 NF……………1.8mg
pH………………………………….6.0
Bacteriostatic Water for Injection
Each 7.2 mL solution contains:
Benzyl Alcohol………………….1.1%
Water for Injection USP……...q.s.


B. Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 440mg
Composition:
Each lyophilized vial contains:
Trastuzumab……………………...440mg
Excipients:
L-Histidine Hydrochloride
Monohydrate EP……………….9.9mg
L- Histidine U.S.P ……………...6.4mg
α, α-Trehalose
dihydrate NF…………………….400mg
Polysorbate 20 NF……………1.8mg
pH………………………………….6.0
Bacteriostatic Water for Injection
Each 20 mL solution contains:
Benzyl Alcohol………………….1.1%
Water for Injection USP……...q.s.

THERAPEUTIC INDICATIONS:

Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion is used in the treatment of breast and stomach cancer. It works by killing the cancer cells by inhibiting HER2 (human epidermal growth factor receptor protein).

PACKING:

150mg: Each pack contains 1vial of lyophilized powder of Trastuzumab, 1 vial with 7.2mL Sterile Bacteriostatic Water for Injection and pack insert.
440mg: Each pack contains 1vial of lyophilized powder of Trastuzumab, 1 vial with 20mL Sterile Bacteriostatic Water for Injection and pack insert.

DIRECTION OF USE:

150mg: Reconstitute the lyophilized powder with 7.2mL of sterile Bacteriostatic Water for Injection for intravenous infusion.
440mg: Reconstitute the lyophilized powder with 20mL of sterile Bacteriostatic Water for Injection for intravenous infusion.
Use within 28 days after reconstitution.
Read insert for precaution and directions before use.

CAUTION:

CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner/Medical Oncologist.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

STORAGE & DOSAGE:

STORAGE: Store the lyophilized powder between 2°C to 8°C.
Store the reconstituted solution between 2°C to 8°C.
Do not freeze the reconstituted solution.
Protect from light.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by the Physician.

Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 150mg Technical Specification:

Product Name:Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 150mg
Brand Name:Epirexza
Strength:150mg, 440mg
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free, nonpyrogenic
Packing:Multi-dose Vial
Route of Administration:For I.V. infusion only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-cancer (breast and stomach cancer)
Indication: Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion is used in the treatment of breast and stomach cancer. It works by killing the cancer cells by inhibiting HER2 (human epidermal growth factor receptor protein).
Storage:Store the lyophilized powder between 2°C to 8°C. Store the reconstituted solution between 2°C to 8°C. Do not freeze the reconstituted solution. Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 150mg
    Composition:
    Each lyophilized vial contains:
    Trastuzumab………………………150mg
    Excipients:
    L-Histidine Hydrochloride
    Monohydrate EP……………….3.36mg
    L- Histidine U.S.P ………………2.16mg
    α, α-Trehalose
    dihydrate NF…………………….136.2mg
    Polysorbate 20 NF……………1.8mg
    pH………………………………….6.0
    Bacteriostatic Water for Injection
    Each 7.2 mL solution contains:
    Benzyl Alcohol………………….1.1%
    Water for Injection USP………q.s.

THERAPEUTIC INDICATION:

Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion is used in the treatment of breast and stomach cancer. It works by killing the cancer cells by inhibiting HER2 (human epidermal growth factor receptor protein).

PACKING:

150mg: Each pack contains 1vial of lyophilized powder of Trastuzumab, 1 vial with 7.2mL Sterile Bacteriostatic Water for Injection and pack insert.

DIRECTION OF USE:

150mg: Reconstitute the lyophilized powder with 7.2mL of sterile Bacteriostatic Water for Injection for intravenous infusion.

Use within 28 days after reconstitution.

Read insert for precaution and directions before use.

CAUTION:

CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner/Medical Oncologist.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

STORAGE AND DOSAGE:

STORAGE: Store the lyophilized powder between 2°C to 8°C.
Store the reconstituted solution between 2°C to 8°C.
Do not freeze the reconstituted solution.
Protect from light.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

DOSAGE: As directed by the Physician.

Note: All Product Pictures shown are for illustration purpose only. Actual product may vary due to product enhancement. *Pictures shown are for illustration purpose only. This by no means shall lead to any liability to the company and mere illustration purpose only.

Why Taj Pharmaceuticals?

At Taj Pharmaceuticals, we take immense pride in our longstanding legacy of pharmaceutical excellence. This heritage has solidified our reputation as a trusted and preferred source for essential medications like Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion. Our unwavering commitment to quality and patient well-being is at the core of everything we do. When it comes to critical medications like Trastuzumab, safety and efficacy are non-negotiable. Taj Pharmaceuticals is dedicated to upholding the highest standards of pharmaceutical manufacturing and quality control. Our state-of-the-art facilities are equipped with cutting-edge technology and adhere to stringent regulatory guidelines to ensure that every product we offer meets the most demanding quality benchmarks. Furthermore, we understand the critical nature of medications like Trastuzumab in the treatment of conditions like breast cancer. Timely and reliable access to such medications can significantly impact a patient’s prognosis and quality of life. Taj Pharmaceuticals is committed to providing a consistent and dependable supply of Trastuzumab, supporting healthcare professionals in their efforts to improve patient outcomes. Our commitment extends beyond the realm of pharmaceuticals. We actively engage in research and development endeavors to explore innovative solutions for unmet medical needs. Taj Pharmaceuticals is dedicated to advancing healthcare, enhancing treatment options, and ultimately contributing to a healthier future for individuals around the world. By choosing Taj Pharmaceuticals, you are aligning with a pharmaceutical partner that not only prioritizes quality and reliability but also shares your commitment to improving healthcare outcomes. We stand as a beacon of trust, offering dependable pharmaceutical solutions that healthcare professionals and patients can rely on with confidence.

What is Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion and its uses:

Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion is a potent medication at the forefront of cancer treatment, particularly in cases of HER2-positive breast cancer and advanced gastric cancer. As a targeted therapy, Trastuzumab operates by specifically homing in on the HER2 protein, a key factor in the uncontrolled growth of cancer cells. By binding to HER2 receptors, it curtails their signaling pathways, effectively impeding the growth and proliferation of cancerous cells. This makes Trastuzumab a crucial tool in the battle against these aggressive forms of cancer.

In breast cancer cases marked by an overexpression of the HER2 protein, Trastuzumab plays a pivotal role across various stages of the disease. Whether in early stages, locally advanced scenarios, or metastatic breast cancer, this medication has demonstrated its effectiveness in slowing down or even halting the progression of the disease. The treatment regimen is meticulously administered under the supervision of healthcare professionals through intravenous infusion after reconstituting the lyophilized powder.

Beyond breast cancer, Trastuzumab also extends its therapeutic reach to advanced gastric or gastroesophageal junction (GEJ) cancer characterized by HER2 overexpression. In this context, Trastuzumab has shown promise in slowing the advancement of this formidable form of cancer. The treatment duration and specifics may vary depending on factors such as cancer stage, individual patient responses, and the inclusion of other treatment modalities like chemotherapy.

Close monitoring during Trastuzumab treatment is imperative. Given its potential impact on cardiac function, healthcare providers incorporate regular heart assessments into the treatment plan. Trastuzumab has revolutionized the prognosis and outcomes for individuals grappling with HER2-positive breast cancer and select forms of gastric cancer. It stands as a beacon of hope, providing patients with effective and targeted treatment options that have the potential to significantly improve their quality of life and overall prognosis.

How does Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion Work:

Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion is a formidable weapon in the fight against cancer, specifically tailored to combat HER2-positive breast cancer and select forms of gastric cancer. This medication’s effectiveness hinges on its ability to target the human epidermal growth factor receptor 2 (HER2) protein, a pivotal player in the uncontrolled growth of cancer cells.

Trastuzumab’s method of action is both precise and selective. It circulates within the bloodstream and, like a guided missile, homes in on cancer cells that overexpress HER2 receptors while leaving normal cells unharmed. Once it binds to these HER2 receptors, Trastuzumab embarks on a critical mission—it interferes with the signaling pathways that fuel the relentless proliferation of cancer cells. By disrupting these pathways, it acts as a potent inhibitor, thwarting the growth and division of cancer cells.

Moreover, Trastuzumab exhibits another layer of therapeutic prowess—it can stimulate the body’s immune system. By doing so, it marshals the immune response to recognize and target cancer cells more effectively, amplifying the medication’s anticancer effects.

Crucially, Trastuzumab is often part of a comprehensive treatment approach. It complements chemotherapy and other cancer therapies, augmenting their effectiveness. This combination approach synergistically enhances treatment outcomes, offering patients a more robust and targeted strategy to combat HER2-positive breast cancer and specific types of gastric cancer.

Trastuzumab represents a milestone in cancer treatment, epitomizing the potential of targeted therapies. It provides renewed hope for patients facing these aggressive forms of cancer by slowing or halting their progression. This targeted and precision-focused approach not only improves treatment outcomes but also reduces the impact on healthy cells, contributing to a better quality of life for individuals on their journey towards recovery.

Benefits of Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion:

Trastuzumab offers a multitude of benefits in the realm of cancer treatment, particularly in the context of HER2-positive breast cancer and select types of gastric cancer. Its most notable advantage lies in its precision—this medication is designed to target cancer cells that overexpress the HER2 protein with exceptional accuracy. This targeted approach means that healthy cells are spared, while cancer cells face the full force of its inhibitory action.

The clinical impact of Trastuzumab is profound. It has significantly improved survival rates and treatment outcomes for individuals with HER2-positive breast cancer, making it a cornerstone in the management of this aggressive form of cancer. Its efficacy is further amplified when used in combination with chemotherapy and other cancer treatments, resulting in higher response rates and increased chances of tumor reduction.

Trastuzumab also plays a crucial role in reducing the risk of cancer recurrence, especially for patients who have undergone surgery for early-stage HER2-positive breast cancer. By specifically targeting cancer cells, it minimizes collateral damage to healthy tissues, contributing to a better quality of life for patients during their treatment journey.

Side Effects of Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion:

While Trastuzumab offers compelling benefits, it is not without its potential side effects. One of the primary concerns is its impact on cardiac health. This medication can lead to heart-related issues, including a decrease in heart function or heart failure. Hence, rigorous cardiac monitoring is essential to detect and manage any cardiac concerns promptly.

Infusion-related reactions are another consideration, with some patients experiencing symptoms like fever, chills, or flu-like sensations during or shortly after Trastuzumab administration. Fortunately, these reactions are typically mild and manageable with appropriate medications.

In rare cases, severe allergic reactions may occur, characterized by symptoms such as rash, itching, swelling, dizziness, or breathing difficulties. Immediate medical attention is crucial in such instances.

Additionally, patients may encounter common side effects such as nausea, vomiting, diarrhea, fatigue, and headaches. These side effects are generally tolerable and tend to improve as treatment progresses.

It’s important to emphasize that while Trastuzumab’s benefits are significant, particularly in improving the prognosis of HER2-positive breast cancer, close monitoring and open communication with healthcare providers are paramount. By actively managing and mitigating potential side effects, patients can derive the maximum benefit from this precision-focused and life-enhancing cancer therapy.

Frequently Asked Questions About Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion:

Certainly! Here are some frequently asked questions about Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion:

  1. What is Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion used for?

Trastuzumab is primarily used in the treatment of HER2positive breast cancer and certain types of gastric cancer. It is a targeted therapy that specifically addresses cancer cells with overexpression of the HER2 protein.

  1. How does Trastuzumab work in treating cancer?

Trastuzumab targets the HER2 protein, which is overexpressed in certain cancer cells. By binding to HER2 receptors, it inhibits signalling pathways that promote cancer cell growth. This targeted action helps slow down or halt the progression of cancer.

  1. What are the benefits of using Trastuzumab in cancer treatment?

Trastuzumab has significantly improved survival rates and treatment outcomes in patients with HER2positive breast cancer. It is also effective in reducing the risk of cancer recurrence after surgery for early stage HER2positive breast cancer.

  1. How is Trastuzumab administered?

Trastuzumab is administered through intravenous (IV) infusion after reconstituting the lyophilized powder. The infusion is typically given in a clinical setting under the supervision of a healthcare provider.

  1. Are there any common side effects of Trastuzumab treatment?

Common side effects of Trastuzumab may include nausea, vomiting, diarrhea, fatigue, and headaches. These side effects are usually manageable and tend to improve over time.

  1. What is the role of Trastuzumab in combination therapies?

Trastuzumab is often used in combination with chemotherapy and other cancer treatments. Its targeted action enhances the effectiveness of these therapies, leading to better response rates and improved chances of tumor reduction.

  1. Is Trastuzumab safe for patients with heart conditions?

Trastuzumab can have an impact on cardiac health and may lead to heart related issues. Close cardiac monitoring is essential during treatment to detect and manage any potential concerns promptly.

  1. How long is Trastuzumab treatment typically administered for?

The duration of Trastuzumab treatment can vary depending on factors like cancer stage, individual patient responses, and the overall treatment plan. It is determined by the treating healthcare provider.

  1. Can allergic reactions occur with Trastuzumab treatment?

In rare cases, severe allergic reactions to Trastuzumab may occur. These reactions may include symptoms like rash, itching, swelling, dizziness, or difficulty breathing. Immediate medical attention is required in such instances.

  1. What should I do if I experience side effects during Trastuzumab treatment?

It’s important to communicate any side effects or concerns with your healthcare provider promptly. They can provide guidance, adjust your treatment plan if necessary, and address any questions you may have.

Please note that specific questions and concerns about Trastuzumab treatment should be discussed with a healthcare professional who can provide personalized guidance based on an individual’s medical history and treatment needs.

As Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion Exporters; We can cater to export business queries from the following geographies. We are exporting our Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion 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

Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion 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 Trastuzumab Lyophilized Powder for Concentrate for Solution for Infusion, 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