post-title portfolio-title Mitomycin for Injection USP 2mg (Mitocyte) 2023-02-20 12:17:23 no no

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Mitomycin for Injection USP 2mg
b) Mitomycin for Injection USP 5mg
c) Mitomycin for Injection USP 10mg
d) Mitomycin for Injection USP 20mg
e) Mitomycin for Injection USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Mitomycin for Injection USP 2mg
Each vial contains:
Mitomycin USP……………….……2mg
Mannitol……..……………….………4mg

b) Mitomycin for Injection USP 5mg
Each vial contains:
Mitomycin USP…………………….5mg
Mannitol………………………………10mg

c) Mitomycin for Injection USP 10mg
Each vial contains:
Mitomycin USP………………….…10mg
Mannitol……..…………………….…20mg

d) Mitomycin for Injection USP 20mg
Each vial contains:
Mitomycin USP……………………20mg
Mannitol……………………………..40mg

e) Mitomycin for Injection USP 40mg
Each vial contains:
Mitomycin USP……………………40mg
Mannitol……………………………..80mg

THERAPEUTIC INDICATION:

Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body.

DIRECTION OF USE:

For Intravenous infusion only.
Add sterile water for injection USP. Shake to dissolve, if product does not dissolve immediately allow to stand at room temperature until solution is obtained.
See the package insert for details.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
Must be administered intravenously to avoid tissue damage.
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]. Protected from light. Avoid excessive heat, over 40°C [104° F]. Protect reconstituted solution from light. Store solution under refrigeration 2°C to 8°C (36° to 46° F), discard after 14 days. If unrefrigerated, discard after 7 days.
Dosage: As directed by an Oncologist.

Mitomycin for Injection USP 2mg (Mitocyte) Technical Specification:

Product Name:Mitomycin for Injection USP 2mg
Brand Name:Mitocyte
Strength:2mg, 5mg, 10mg, 20mg, 40mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE 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: Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body.
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]. Protected from light. Avoid excessive heat, over 40°C [104° F]. Protect reconstituted solution from light. Store solution under refrigeration 2°C to 8°C (36° to 46° F), discard after 14 days. If unrefrigerated, discard after 7 days.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mitomycin for Injection USP 2mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mitomycin for Injection USP 2mg
    Each vial contains:
    Mitomycin USP……………….……2mg
    Mannitol……..……………….………4mg

THERAPEUTIC INDICATION:

Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body.

DIRECTION OF USE:

For Intravenous infusion only.
Add sterile water for injection USP. Shake to dissolve, if product does not dissolve immediately allow to stand at room temperature until solution is obtained.
See the package insert for details.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.|
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
For cytotoxic special handling procedures see insert
Must be administered intravenously to avoid tissue damage.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard the Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68°F to 77 °F); excursions permitted between 15°C to 30°C (59°F to 86 °F) [See USP Controlled Room Temperature]. Protected from light. Avoid excessive heat, over 40°C [104° F]. Protect reconstituted solution from light. Store solution under refrigeration 2°C to 8°C (36° to 46° F), discard after 14 days. If unrefrigerated, discard after 7 days.
Dosage: As directed by an Oncologist.

Why Taj Pharmaceuticals? 

The choice of Taj Pharmaceuticals for Mitomycin for Injection USP is driven by several crucial factors that hold significance in the healthcare industry. One of the primary considerations is quality assurance. Taj Pharmaceuticals, as a reputable pharmaceutical company, is expected to maintain stringent quality control standards and adhere to good manufacturing practices (GMP). For a medication as critical as Mitomycin for Injection, maintaining the highest quality is essential to ensure that the drug remains potent, safe, and effective for patients. Product availability is another key factor. Medication availability can vary depending on the manufacturer. Opting for a trusted pharmaceutical manufacturer like Taj Pharmaceuticals can provide healthcare facilities and patients with a dependable and consistent supply of Mitomycin for Injection, thus minimizing interruptions in patient care.

The reputation of a pharmaceutical company is of paramount importance. Companies with a well-established history of producing high-quality and reliable medications are often preferred by healthcare professionals and institutions. A strong reputation for quality and safety is particularly crucial when selecting a manufacturer for critical medications such as Mitomycin. Regulatory compliance is a fundamental requirement for pharmaceutical manufacturers. Companies like Taj Pharmaceuticals are expected to meet the regulatory standards set by health authorities in various countries. This involves obtaining the necessary approvals, licenses, and registrations to ensure that the medication is manufactured and distributed legally and safely.

Research and development efforts also play a role in the decision-making process. Some pharmaceutical companies invest in research and development to enhance existing medications or create new formulations. Such endeavors can lead to improvements in medication effectiveness or safety, which can be advantageous for patients. Proper packaging and accurate labeling are essential attributes of medications. Reputable pharmaceutical manufacturers prioritize clear, informative packaging, and labeling to ensure that healthcare providers and patients can use the medication safely and appropriately.

Support services provided by pharmaceutical companies are another valuable asset. This support includes offering information on proper medication administration, dosing guidelines, and potential side effects. Such services are instrumental in ensuring the safe and effective use of medications. Consistency in dosage and formulation is paramount. Patients and healthcare providers rely on consistent dosages and formulations to ensure that patients receive the correct treatment, which reputable pharmaceutical manufacturers strive to maintain. Reliability in the supply chain is a crucial consideration for healthcare facilities. Knowing that a pharmaceutical company like Taj Pharmaceuticals can consistently deliver Mitomycin for Injection on time allows healthcare providers to plan and manage patient care effectively.

While maintaining quality and safety remains paramount, cost efficiency is also a consideration. Reputable manufacturers often strike a balance between quality and cost-effectiveness, acknowledging that cost considerations are essential for healthcare providers and institutions. In conclusion, the selection of Taj Pharmaceuticals or any pharmaceutical manufacturer for Mitomycin for Injection USP hinges on a combination of factors, including quality, reputation, regulatory compliance, reliability, and support services, all of which prioritize patient safety and the highest standards of medication quality and efficacy.

What is Mitomycin for Injection USP and its uses?

Mitomycin for Injection USP is a medication used in the treatment of various types of cancer. It contains the active ingredient mitomycin, which is an antineoplastic (anticancer) antibiotic. Mitomycin is typically administered as an injectable solution and is used in oncology and chemotherapy settings. Here’s an overview of Mitomycin for Injection USP and its uses:

Uses:

  • Cancer Treatment: Mitomycin for Injection USP is primarily used in the treatment of certain types of cancer. It is commonly employed in the management of:
    Stomach (Gastric) Cancer: Mitomycin may be used in combination with other chemotherapy drugs to treat stomach cancer, often as part of an overall treatment plan that may include surgery and radiation therapy.
    Pancreatic Cancer: It may be used as a part of chemotherapy regimens for pancreatic cancer, either alone or in combination with other anticancer medications.
    Breast Cancer: In some cases, Mitomycin may be used as part of a chemotherapy regimen for breast cancer.
    Colorectal (Colon) Cancer: Mitomycin may be used in the treatment of colorectal cancer, especially when the cancer has spread to other parts of the body (metastatic).
    Bladder Cancer: It is used as an intravesical treatment, where it is instilled directly into the bladder, to prevent the recurrence of superficial bladder cancer after surgical resection.
    Lung Cancer: Mitomycin may be considered for certain cases of nonsmall cell lung cancer, particularly when other treatments have not been effective.
  • Gastrointestinal Tumors: Mitomycin can also be used in the management of gastrointestinal tumors, such as carcinoid tumors, which develop in the gastrointestinal tract.
  • Ovarian Cancer: In some cases, Mitomycin may be included in chemotherapy regimens for ovarian cancer, especially in advanced stages.
  • Other Cancers: It may be used in the treatment of other types of cancer, depending on the specific circumstances and medical judgment.

Mitomycin works by interfering with the DNA in cancer cells, inhibiting their ability to divide and grow. It is often administered intravenously under the supervision of a healthcare provider experienced in chemotherapy. The dosing and treatment schedule can vary based on the type of cancer being treated, the patient’s overall health, and other factors.

How does Mitomycin for Injection USP Work?

Mitomycin for Injection USP works as an anticancer medication by interfering with the DNA (genetic material) within cancer cells. It belongs to a class of drugs known as alkylating agents. Here’s how Mitomycin works:

  • DNA Damage: Mitomycin is administered intravenously, and once it enters the bloodstream, it is taken up by both normal and cancer cells. Inside the cells, Mitomycin undergoes a chemical conversion and is activated by cellular enzymes.
  • Alkylating Effect: The activated form of Mitomycin acts as an alkylating agent. Alkylating agents have the ability to chemically modify the DNA within cells. Specifically, Mitomycin creates chemical cross-links between the two strands of DNA, effectively “cross-linking” them together.
  • DNA Cross-Links: The cross-linking of DNA strands by Mitomycin disrupts the normal structure of DNA and prevents the strands from separating properly during DNA replication and cell division.
  • Cell Cycle Arrest: As a result of these DNA cross-links, cancer cells are unable to replicate their DNA and divide. This leads to a halt in the cell cycle at the S phase, where DNA replication normally occurs.
  • Cell Death: Cancer cells that cannot complete the cell cycle and divide are ultimately unable to grow and proliferate. In response to DNA damage, cells may undergo programmed cell death (apoptosis) or become less viable. This effectively reduces the number of cancer cells in the body.

Mitomycin’s action is not selective for cancer cells alone; it can also affect normal, healthy cells to some extent. However, cancer cells are often more vulnerable to DNA damage because they tend to divide rapidly and may have impaired DNA repair mechanisms compared to normal cells. Therefore, Mitomycin preferentially targets cancer cells, although normal cells can still be affected. The effectiveness of Mitomycin for Injection USP in treating cancer depends on factors such as the type and stage of cancer, the overall health of the patient, and the specific treatment regimen used. It is typically administered as part of a chemotherapy regimen, often in combination with other anticancer medications, surgery, or radiation therapy, depending on the individual patient’s condition and the goals of treatment. It’s important to note that Mitomycin for Injection USP is a potent medication with potential side effects, and its use should be carefully monitored by a healthcare provider experienced in cancer treatment. The dosing and treatment plan is tailored to each patient’s specific needs to maximize the benefits of treatment while minimizing potential risks.

Benefits of Mitomycin for Injection USP:

Mitomycin for Injection USP is a potent anticancer medication that offers potential benefits in the treatment of various types of cancer. However, like many chemotherapy drugs, it can also be associated with side effects. Here are the benefits of Mitomycin for Injection USP

  • Cancer Treatment: The primary benefit of Mitomycin for Injection USP is its effectiveness in treating certain types of cancer. It is commonly used in the management of stomach (gastric) cancer, pancreatic cancer, colorectal cancer, bladder cancer, breast cancer, and other malignancies. Mitomycin works by interfering with the DNA of cancer cells, preventing their replication and growth.
  • Reduction in Tumor Size: Mitomycin can often shrink tumors, which can provide relief from cancer-related symptoms such as pain, discomfort, or pressure on surrounding organs and tissues.
  • Adjunct to Other Treatments: It is frequently used in combination with other cancer treatments like surgery, radiation therapy, or additional chemotherapy drugs to improve treatment outcomes. In some cases, Mitomycin may be part of a multidisciplinary approach to cancer care.

Potential Side Effects of Mitomycin for Injection USP:

  • Nausea and Vomiting: Nausea and vomiting are common side effects of chemotherapy, including Mitomycin. Medications known as antiemetics are often prescribed to help manage these symptoms.
  • Bone Marrow Suppression: Mitomycin can affect the bone marrow’s ability to produce blood cells, including red blood cells, white blood cells, and platelets. This can lead to anemia (low red blood cell count), neutropenia (low white blood cell count), and thrombocytopenia (low platelet count), which can increase the risk of infection, fatigue, and bleeding.
  • Weakened Immune System: The suppression of white blood cell production can weaken the immune system, making the patient more susceptible to infections.
  • Hair Loss: Many chemotherapy drugs, including Mitomycin, can cause temporary hair loss (alopecia). Hair typically grows back after treatment ends.
  • Fatigue: Chemotherapy often leads to fatigue and general weakness. Patients may need to adjust their activities and get extra rest during treatment.
  • Gastrointestinal Issues: Diarrhea, constipation, and abdominal pain are possible gastrointestinal side effects of Mitomycin.
  • Kidney and Liver Function: Mitomycin can affect kidney and liver function. Regular monitoring of these organs’ function is essential during treatment.
  • Infertility: Mitomycin may impair fertility in both men and women. Patients of childbearing age should discuss fertility preservation options with their healthcare team before starting treatment.
  • Skin and Nail Changes: Some patients may experience changes in their skin and nails, such as skin dryness, rash, or nail discoloration.
  • Allergic Reactions: In rare cases, Mitomycin can cause allergic reactions, which may include rash, itching, swelling, and difficulty breathing. Immediate medical attention is needed if such reactions occur.

It’s important to note that the specific side effects and their severity can vary from person to person. The healthcare team will closely monitor patients during treatment and provide supportive care to manage side effects effectively. The decision to use Mitomycin for Injection USP is based on the potential benefits of cancer treatment weighed against the risks of side effects, and it should be made in consultation with a healthcare provider experienced in oncology.

Frequently Asked Questions About Mitomycin for Injection USP:

Here are some frequently asked questions about Mitomycin for Injection USP:

  1. What is Mitomycin for Injection USP used for?

Mitomycin for Injection USP is primarily used in the treatment of various types of cancer. It is often prescribed as part of chemotherapy regimens to inhibit the growth and spread of cancer cells.

  1. How does Mitomycin for Injection USP work?

Mitomycin works by interfering with the DNA of cancer cells, preventing their replication and growth. It forms chemical crosslinks within the DNA strands, disrupting normal cell division.

  1. What types of cancer is Mitomycin for Injection USP used to treat?

Mitomycin is commonly used in the treatment of stomach (gastric) cancer, pancreatic cancer, colorectal cancer, bladder cancer, breast cancer, and other malignancies. Its use may vary depending on the specific type and stage of cancer.

  1. Is Mitomycin for Injection USP a curative treatment for cancer?

Mitomycin is typically used as part of a comprehensive cancer treatment plan, but it may not be curative on its own. The effectiveness of treatment depends on the type and stage of cancer and the overall health of the patient.

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

Common side effects may include nausea, vomiting, bone marrow suppression (leading to anemia, neutropenia, and thrombocytopenia), hair loss, fatigue, gastrointestinal issues, and changes in skin and nails.

  1. How is Mitomycin for Injection USP administered?

Mitomycin is administered through an intravenous (IV) infusion in a clinical setting. The dosage and treatment schedule are determined by the healthcare provider based on the patient’s condition.

  1. Can Mitomycin for Injection USP be used in combination with other cancer treatments?

Yes, Mitomycin is often used in combination with surgery, radiation therapy, or other chemotherapy drugs to enhance treatment outcomes. The specific combination depends on the type and stage of cancer.

  1. Is Mitomycin for Injection USP safe during pregnancy or breastfeeding?

Mitomycin can be harmful to a developing fetus, and it is not recommended during pregnancy. It may also be excreted in breast milk, so breastfeeding is generally not advised during treatment. Patients of childbearing age should discuss contraception with their healthcare provider.

  1. Are there any special precautions or monitoring required during Mitomycin treatment?

Regular monitoring of blood cell counts, kidney function, and liver function is essential during Mitomycin treatment. Patients should communicate any unusual symptoms or side effects to their healthcare team.

  1. What should I do if I miss a dose of Mitomycin for Injection USP?

Mitomycin doses are typically administered in a healthcare setting by trained professionals. It’s unlikely for a patient to miss a dose, but if there are concerns, they should consult with their healthcare provider for guidance on their specific situation.

Patients should always discuss their questions and concerns about Mitomycin for Injection USP with their healthcare provider, as treatment plans and recommendations may vary based on individual circumstances.

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

Mitomycin for 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 Mitomycin for 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

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