Gemcitabine for Injection USP 200mg (Gemilife) Technical Specification:

Product Name:Gemcitabine for Injection USP 200mg
Brand Name:Gemilife
Strength:200mg, 1000mg, 1.4gm, 2gm
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE DOSE VIAL
Route of Administration:For I.V. infusion 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: Gemcitabine is used in combination with other medicines to treat a type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body and cannot be treated with surgery and also use to treat advanced ovarian cancer.
Storage:Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Do not refrigerate after reconstitution.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Gemcitabine for Injection USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Gemcitabine for Injection USP 200mg
    Each sterile lyophilized vial contains
    Gemcitabine Hydrochloride USP
    Equivalent to Gemcitabine……..200mg
    Excipients……………………………….q.s.

THERAPEUTIC INDICATION:

Gemcitabine is used in combination with other medicines to treat a type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body and cannot be treated with surgery and also use to treat advanced ovarian cancer.

DIRECTION OF USE:

For Intravenous infusion only.
Reconstitution for 200mg: Reconstitute with 5ml Sodium Chloride injection IP (0.9% w/v) and shake gently to make a clear solution
Please refer accompanying package 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 reconstitution.
Patients receiving therapy with Gemcitabine for Injection should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents. Solutions of reconstituted Gemcitabine for Injection should not be refrigerated, as crystallization may occur.
Gemcitabine Hydrochloride is potentially cytotoxic. Great care should be taken to prevent inhaling particles and exposing the skin to it.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Infusion time and dose frequency: Increased toxicity with infusion time >60 minutes or dosing more frequently than once weekly.
WARNINGS AND PRECAUTIONS
Gemcitabine is used with cisplatin is indicated at first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
CONTRAINDICATIONS
Gemcitabine for Injection is contraindicated in those patients with a known hypersensitivity to the drug.
Administer solution within 24 hours.
Do not refrigerate after reconstitution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Do not refrigerate after reconstitution.
Dosage: As directed by an Oncologist.

Why Taj pharmaceuticals?

Taj Pharmaceuticals has established itself as a reputable and dependable provider of Gemcitabine for Injection, offering compelling reasons why it stands out as a preferred choice for healthcare professionals and patients alike.

One of the cornerstones of Taj Pharmaceuticals’ reputation is its unwavering commitment to quality assurance. Gemcitabine for Injection from Taj undergoes rigorous quality control procedures, ensuring that each vial contains a pharmaceutical product of exceptional quality. This dedication to quality provides peace of mind to healthcare providers and patients alike, knowing they can rely on the consistency and reliability of the medication.

Taj Pharmaceuticals places significant emphasis on research and development, continually seeking ways to improve and innovate in the field of pharmaceuticals. This commitment translates into a range of advanced formulations and delivery methods for Gemcitabine, allowing healthcare providers the flexibility to choose the most suitable options for their patients’ needs.

With a global reach, Taj Pharmaceuticals ensures that Gemcitabine for Injection is accessible to patients and healthcare providers worldwide. This expansive distribution network means that individuals facing cancer can benefit from this vital medication, regardless of their geographic location.

Taj Pharmaceuticals boasts a wealth of experience and expertise in pharmaceutical manufacturing. Over the years, the company has built a track record of delivering high-quality medications. This track record instills confidence in healthcare professionals who trust the reliability and consistency of Gemcitabine for Injection from Taj.

At its core, Taj Pharmaceuticals embraces a patient-centric approach, making the well-being and satisfaction of patients a top priority. This commitment extends beyond the product itself and encompasses the provision of accurate information, support, and resources to both patients and healthcare providers.

Crucially, Taj Pharmaceuticals ensures compliance with rigorous regulatory standards, meeting all necessary requirements for safety, efficacy, and quality. This commitment to regulatory compliance reinforces the confidence of healthcare professionals and patients in the product’s safety and effectiveness.

Lastly, Taj Pharmaceuticals maintains a dedication to continuous improvement. Feedback from healthcare providers and patients is valued and actively used to refine products and services continually, ensuring that Gemcitabine for Injection remains at the forefront of cancer treatment.

In summary, Gemcitabine for Injection from Taj Pharmaceuticals is underpinned by a steadfast commitment to quality, ongoing research and development, global accessibility, extensive experience, a patient-centered philosophy, regulatory adherence, and an unwavering dedication to continuous improvement. This makes Taj Pharmaceuticals a trusted partner in the fight against cancer, offering healthcare providers and patients the assurance that they are supported by a pharmaceutical company committed to their well-being.

What is Gemcitabine for Injection and its uses?

Gemcitabine for Injection: A Trusted Pharmaceutical Choice from Taj Pharmaceuticals

Taj Pharmaceuticals has established itself as a reputable and dependable provider of Gemcitabine for Injection, offering compelling reasons why it stands out as a preferred choice for healthcare professionals and patients alike.

One of the cornerstones of Taj Pharmaceuticals’ reputation is its unwavering commitment to quality assurance. Gemcitabine for Injection from Taj undergoes rigorous quality control procedures, ensuring that each vial contains a pharmaceutical product of exceptional quality. This dedication to quality provides peace of mind to healthcare providers and patients alike, knowing they can rely on the consistency and reliability of the medication.

Taj Pharmaceuticals places significant emphasis on research and development, continually seeking ways to improve and innovate in the field of pharmaceuticals. This commitment translates into a range of advanced formulations and delivery methods for Gemcitabine, allowing healthcare providers the flexibility to choose the most suitable options for their patients’ needs.

With a global reach, Taj Pharmaceuticals ensures that Gemcitabine for Injection is accessible to patients and healthcare providers worldwide. This expansive distribution network means that individuals facing cancer can benefit from this vital medication, regardless of their geographic location.

Taj Pharmaceuticals boasts a wealth of experience and expertise in pharmaceutical manufacturing. Over the years, the company has built a track record of delivering high-quality medications. This track record instills confidence in healthcare professionals who trust the reliability and consistency of Gemcitabine for Injection from Taj.

At its core, Taj Pharmaceuticals embraces a patient-centric approach, making the well-being and satisfaction of patients a top priority. This commitment extends beyond the product itself and encompasses the provision of accurate information, support, and resources to both patients and healthcare providers.

Crucially, Taj Pharmaceuticals ensures compliance with rigorous regulatory standards, meeting all necessary requirements for safety, efficacy, and quality. This commitment to regulatory compliance reinforces the confidence of healthcare professionals and patients in the product’s safety and effectiveness.

Lastly, Taj Pharmaceuticals maintains a dedication to continuous improvement. Feedback from healthcare providers and patients is valued and actively used to refine products and services continually, ensuring that Gemcitabine for Injection remains at the forefront of cancer treatment.

In summary, Gemcitabine for Injection from Taj Pharmaceuticals is underpinned by a steadfast commitment to quality, ongoing research and development, global accessibility, extensive experience, a patient-centered philosophy, regulatory adherence, and an unwavering dedication to continuous improvement. This makes Taj Pharmaceuticals a trusted partner in the fight against cancer, offering healthcare providers and patients the assurance that they are supported by a pharmaceutical company committed to their well-being.

How does Gemcitabine for Injection Work?

How Gemcitabine for Injection Works in Cancer Treatment

Gemcitabine for Injection is a crucial chemotherapy medication renowned for its role in impeding the growth and progression of cancer. Its mechanism of action is multifaceted and targeted at disrupting the fundamental processes that enable cancer cells to thrive.

At the heart of Gemcitabine’s efficacy lies its ability to inhibit DNA synthesis within cancer cells. By masquerading as a structural component of DNA, it is incorporated into the growing DNA strands during replication. However, once integrated, Gemcitabine acts as a deceptive building block, effectively halting further DNA synthesis. This interference is a significant blow to cancer cells, as DNA replication is essential for their proliferation.

Gemcitabine doesn’t stop at DNA; it also intervenes in RNA synthesis, a critical step in protein production. By disrupting this process, the medication hampers the cancer cells’ ability to generate essential proteins required for their survival and growth.

Moreover, Gemcitabine has the ability to induce programmed cell death, known as apoptosis, in cancer cells. This is a natural cellular process used to eliminate damaged or superfluous cells. Gemcitabine effectively triggers this self-destructive mechanism within cancer cells, leading to their demise.

In specific cancer treatment regimens, Gemcitabine is strategically combined with radiation therapy, further enhancing its impact. It sensitizes cancer cells to the damaging effects of radiation, augmenting the overall effectiveness of the treatment.

Furthermore, Gemcitabine may disrupt the formation of new blood vessels, a process called angiogenesis, that tumors rely on to receive nutrients and oxygen. This dual action not only inhibits cancer cell growth but also starves tumors of their vital supplies.

While Gemcitabine’s mechanism of action is a formidable weapon against cancer, it’s essential to acknowledge that it can affect normal, healthy cells, potentially leading to side effects. The art of chemotherapy lies in selectively targeting cancer cells while minimizing harm to healthy tissue. The precise use, dosage, and timing of Gemcitabine, along with any combination therapies, are judiciously determined by oncologists based on factors such as the patient’s cancer type, stage, and overall health.

Patients under Gemcitabine for Injection treatment undergo close monitoring by healthcare professionals to manage and mitigate potential side effects, ensuring the best possible outcome from the therapy.

Benefits of Gemcitabine for Injection:

Gemcitabine for Injection offers several significant benefits in the realm of cancer treatment. Firstly, it stands as an effective and well-established chemotherapy medication known for its ability to combat various types of cancer. This efficacy extends to cancers like pancreatic, lung, bladder, breast, ovarian, and more, making it a versatile tool in the oncologist’s arsenal.

Secondly, Gemcitabine’s flexibility shines through in its compatibility with combination therapy. It often partners with other chemotherapy agents or radiation therapy to amplify its impact on cancer cells. This synergistic approach can yield more robust treatment outcomes, affording patients a more aggressive strategy for managing their cancer.

Additionally, Gemcitabine is appreciated for its role in alleviating cancer-related symptoms. For individuals grappling with advanced or metastatic cancer, it can provide relief by reducing pain, addressing obstructive symptoms, and overall, enhancing their quality of life.

Side Effects of Gemcitabine for Injection:

Conversely, the use of Gemcitabine for Injection is associated with various side effects that patients and healthcare providers must navigate. One of the most common is nausea and vomiting, which can be managed with prescribed anti-nausea medications.

Another set of side effects pertains to blood cell counts. Gemcitabine can lead to decreased counts of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia). These conditions can result in fatigue, heightened vulnerability to infections, and an increased risk of bleeding or bruising.

Patients may also experience flu-like symptoms, including fever, chills, and muscle aches following Gemcitabine administration. These symptoms can typically be addressed with medications and tend to improve with continued treatment.

Fatigue is a frequent side effect in individuals undergoing chemotherapy, and Gemcitabine is no exception. Patients may contend with persistent tiredness and reduced energy levels.

Skin-related side effects, such as a rash or irritation, are possible but generally manageable. Informing healthcare providers can help address these symptoms effectively.

Kidney and liver function may be affected by Gemcitabine, leading to elevated blood markers. Regular monitoring is essential to detect and manage any issues in a timely manner.

Hair loss or thinning, although less common than with some other chemotherapy drugs, is a potential side effect of Gemcitabine. Fortunately, this effect is usually temporary, and hair typically regrows after treatment.

Peripheral neuropathy, characterized by tingling or numbness in the hands and feet, can occur in some individuals. This condition may impact dexterity and balance.

Finally, although rare, allergic reactions can transpire, resulting in symptoms such as itching, hives, swelling, or breathing difficulties. Immediate medical attention is imperative in such cases.

The choice to use Gemcitabine is always based on a careful evaluation of its potential benefits in cancer control and the manageable risks of side effects. Healthcare providers closely monitor patients, make necessary dosage adjustments, and offer supportive care to effectively manage side effects. Patients are encouraged to engage in open discussions with their healthcare team to address any concerns or questions, ensuring the best possible outcome from their treatment.

Frequently Asked Questions About Gemcitabine for Injection:

  1. What is Gemcitabine for Injection used to treat?

Gemcitabine for Injection is used to treat various types of cancer, including pancreatic cancer, lung cancer, bladder cancer, breast cancer, ovarian cancer, and others. It is a versatile chemotherapy medication employed to slow down cancer growth and improve treatment outcomes.

  1. How is Gemcitabine for Injection administered?

Gemcitabine is administered intravenously (IV) by a healthcare professional in a clinical setting. The exact dosage and treatment schedule are determined by the oncologist based on the patient’s specific cancer type and overall health.

  1. Can Gemcitabine for Injection be used as a single treatment, or is it usually combined with other medications?

Gemcitabine is often used in combination with other chemotherapy agents or radiation therapy to enhance its effectiveness. Combination therapy is tailored to the individual’s cancer diagnosis and stage.

  1. What are the common side effects of Gemcitabine for Injection?

Common side effects may include nausea, vomiting, low blood cell counts (anemia, leukopenia, thrombocytopenia), flu-like symptoms, fatigue, skin rash, kidney and liver effects, hair loss, peripheral neuropathy, and, rarely, allergic reactions. Side effects can vary from person to person.

  1. How are the side effects of Gemcitabine managed?

Healthcare providers can manage side effects with medications and supportive care. Anti-nausea drugs can help with nausea and vomiting, and regular blood tests monitor blood cell counts. Patients are encouraged to communicate openly with their healthcare team about any side effects.

  1. Is hair loss permanent with Gemcitabine treatment?

Hair loss or thinning may occur during Gemcitabine treatment but is generally temporary. Hair often regrows after the completion of treatment.

  1. Can Gemcitabine for Injection cure cancer?

Gemcitabine is primarily used to control and manage cancer by slowing its growth and relieving symptoms. It may lead to remission in some cases, but its potential for a cure depends on factors such as cancer type and stage.

  1. Are there any special precautions for patients receiving Gemcitabine?

Patients should inform their healthcare team about any pre-existing medical conditions, medications, or allergies. It’s essential to attend all scheduled appointments for blood tests and follow-up visits during treatment.

  1. What should I do if I experience an allergic reaction to Gemcitabine?

While allergic reactions to Gemcitabine are rare, they require immediate medical attention. If you experience symptoms like itching, hives, swelling, or difficulty breathing after Gemcitabine administration, alert your healthcare provider or seek emergency care.

  1. Can I continue working and maintaining daily activities while on Gemcitabine treatment?

The ability to work and carry out daily activities during Gemcitabine treatment varies from person to person and depends on factors like the type of cancer, treatment schedule, and side effects experienced. It’s advisable to discuss these aspects with your healthcare team to plan accordingly.

Patients should consult with their oncologist and healthcare team to address specific questions and concerns related to Gemcitabine for Injection treatment, as individual experiences and circumstances may vary. Open communication with healthcare providers is key to optimizing cancer treatment and managing side effects effectively.

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

Gemcitabine for 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  Gemcitabine for 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) Gemcitabine for Injection USP 200mg
b) Gemcitabine for Injection USP 1000mg
c) Gemcitabine for Injection USP 1.4gm
d) Gemcitabine for Injection USP 2gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Gemcitabine for Injection USP 200mg
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..200mg
Excipients……………………………….q.s.


b) Gemcitabine for Injection USP 1000mg
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..1000mg
Excipients……………………………….q.s.

c) Gemcitabine for Injection USP 1.4gm
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..1.4gm
Excipients……………………………….q.s.

d) Gemcitabine for Injection USP 2gm
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..2gm
Excipients……………………………….q.s.

THERAPEUTIC INDICATION:

Gemcitabine is used in combination with other medicines to treat a type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body and cannot be treated with surgery and also use to treat advanced ovarian cancer.

DIRECTION OF USE:

For Intravenous infusion only.
Reconstitution for 200mg: Reconstitute with 5ml Sodium Chloride injection IP (0.9% w/v) and shake gently to make a clear solution
Please refer accompanying package 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 reconstitution.
Patients receiving therapy with Gemcitabine for Injection should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents. Solutions of reconstituted Gemcitabine for Injection should not be refrigerated, as crystallization may occur.
Gemcitabine Hydrochloride is potentially cytotoxic. Great care should be taken to prevent inhaling particles and exposing the skin to it.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Infusion time and dose frequency: Increased toxicity with infusion time >60 minutes or dosing more frequently than once weekly.
WARNINGS AND PRECAUTIONS
Gemcitabine is used with cisplatin is indicated at first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
CONTRAINDICATIONS
Gemcitabine for Injection is contraindicated in those patients with a known hypersensitivity to the drug.
Administer solution within 24 hours.
Do not refrigerate after reconstitution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Do not refrigerate after reconstitution.
Dosage: As directed by an Oncologist.