Dacarbazine for Injection USP 200mg FDA Manufacturers India

Dacarbazine for Injection USP 200mg (Onivdryl) Technical Specification:

Product Name:	Dacarbazine for Injection USP 200mg
Brand Name:	Onivdryl
Strength:	100mg, 200mg, 500mg
Dosage Form:	Lyophilized Dry Powder for Injection
Packing:	SINGLE USE 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:	Dacarbazine is used to treat cancer of the lymph system and malignant melanoma (a type of skin cancer). It may also be used to treat other kinds of cancer, as determined by your doctor. Dacarbazine interferes with the growth of cancer cells, which are eventually destroyed.
Storage:	Store the vials in the original carton between 2°C to 8°C (36° to 46° F). Do not freeze. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Dacarbazine for Injection USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Dacarbazine for Injection USP 200mg
Each sterile lyophilized vial contains:
Dacarbazine USP…………………200mg
Excipients:
Anhydrous Citric Acid USP…..q.s.
Mannitol USP………………………q.s.
Water for Injection USP………q.s.

THERAPEUTIC INDICATION:

Dacarbazine is used to treat cancer of the lymph system and malignant melanoma (a type of skin cancer). It may also be used to treat other kinds of cancer, as determined by your doctor. Dacarbazine interferes with the growth of cancer cells, which are eventually destroyed.

DIRECTION OF USE:

For Intravenous use only.

Reconstitution for 200mg: Reconstitute with 19.7 ml of Sterile Water for Injection USP to get a concentration of 10mg/ml of Dacarbazine.

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.

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

NOTE: Use within 8 hours of Reconstitution.

Prepared as the citrate salt.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store the vials in the original carton between 2°C to 8°C (36° to 46° F).

Do not freeze. Protect from light.

Dosage: As directed by an Oncologist.

Why Taj Pharmaceuticals?

At Taj Pharma, we prioritize your health and well-being. Our Dacarbazine for Injection USP is a testament to our dedication to producing safe and effective medications. We adhere to stringent quality control measures, ensuring that every vial of Dacarbazine meets the highest pharmaceutical standards. With our state-of-the-art manufacturing facilities and a team of experienced professionals, we are at the forefront of cancer treatment solutions. Moreover, we understand that a cancer diagnosis can be challenging, and that’s why we are committed to providing not only superior pharmaceuticals but also unwavering support to healthcare providers and patients. Our mission is to make a positive impact on cancer care by consistently delivering top-quality medications like Dacarbazine, which is used to treat various types of cancer, including melanoma and Hodgkin’s lymphoma. Choose Taj Pharma for Dacarbazine for Injection USP, and you’re choosing a partner in your fight against cancer. Our commitment to excellence, patient-centric approach, and cutting-edge research make us the preferred choice for healthcare professionals and patients alike. Trust Taj Pharma for a brighter, healthier future.

What is Dacarbazine for Injection USP and its use?

Dacarbazine for Injection USP is a medication used in the treatment of various types of cancer. It is classified as an alkylating agent and is specifically categorized as an antineoplastic agent. The active ingredient in Dacarbazine is dacarbazine, and it is typically administered intravenously by a healthcare professional.

Uses of Dacarbazine for Injection USP:

Treatment of Metastatic Melanoma: Dacarbazine is commonly used in the treatment of metastatic melanoma, which is a type of skin cancer that has spread to other parts of the body. It may be used alone or in combination with other cancer medications.
Treatment of Hodgkin’s Lymphoma: Dacarbazine is also used in the treatment of Hodgkin’s lymphoma, a type of cancer that affects the lymphatic system. It is often part of combination chemotherapy regimens for this condition.
Other Cancers: In some cases, healthcare providers may prescribe Dacarbazine for other types of cancer, such as soft tissue sarcomas and certain types of brain tumors.

Like many chemotherapy drugs, Dacarbazine may have side effects, which can vary from person to person. Common side effects may include nausea, vomiting, fatigue, lowered blood cell counts (increasing the risk of infection and bleeding), and flu-like symptoms. Patients should discuss potential side effects and any concerns with their healthcare provider.

Dacarbazine is an important tool in the fight against certain types of cancer, and its use is guided by medical professionals who carefully assess its benefits and risks for each individual patient.

How does Dacarbazine for Injection USP Work?

Dacarbazine for Injection USP works as an anticancer medication primarily by interfering with the growth and replication of cancer cells. It belongs to a class of drugs known as alkylating agents, and its active ingredient is dacarbazine. Here’s how Dacarbazine works:

Alkylation of DNA: Dacarbazine undergoes chemical reactions in the body that ultimately result in the formation of alkyl groups. These alkyl groups are highly reactive and can attach themselves to the DNA molecules within the nucleus of cancer cells.
DNA Damage: When the alkyl groups attach to the DNA strands of cancer cells, they disrupt the normal structure and function of the DNA. This interference prevents the DNA from properly replicating and repairing itself, ultimately leading to DNA damage.
Inhibition of Cell Division: The damaged DNA is unable to undergo normal cell division and replication. As a result, the affected cancer cells are unable to proliferate and grow. This can lead to cell death or a halt in the growth of the tumor.
Cell Death: In some cases, the extent of DNA damage caused by Dacarbazine is severe enough to trigger programmed cell death, known as apoptosis. This is a natural process in which damaged or abnormal cells self-destruct to protect the body.

Dacarbazine is typically used in combination with other chemotherapy drugs, and the specific treatment regimen and dosages are determined by the type and stage of cancer being treated, as well as the patient’s overall health. The goal of Dacarbazine therapy is to slow down or halt the growth of cancer cells, shrink tumors, and ultimately improve the patient’s prognosis and quality of life. As with all cancer treatments, Dacarbazine for Injection USP is administered under the guidance of oncologists and healthcare professionals who carefully consider its benefits and potential risks for each individual patient.

Benefits of Dacarbazine for Injection USP:

Effective Cancer Treatment: Dacarbazine is an effective chemotherapy medication used to treat various types of cancer, including metastatic melanoma and Hodgkin’s lymphoma. It can help shrink tumors and slow down or halt the growth of cancer cells.
Part of Combination Therapy: Dacarbazine is often used as part of combination chemotherapy regimens, where it is combined with other anticancer drugs to enhance treatment outcomes. This approach may increase the overall effectiveness of cancer treatment.
Tumor Reduction: Dacarbazine’s ability to damage DNA and interfere with the replication of cancer cells can lead to the shrinkage of tumors, potentially making them more manageable or operable.
Improved Survival Rates: In some cases, Dacarbazine treatment can lead to improved survival rates and a better prognosis for individuals with certain types of cancer, particularly when used in combination with other therapies.

Side Effects of Dacarbazine for Injection USP:

Nausea and Vomiting: Nausea and vomiting are among the most common side effects of Dacarbazine. Healthcare providers often prescribe anti-nausea medications to manage these symptoms.
Fatigue: Many individuals experience fatigue or weakness during and after Dacarbazine treatment. This can affect daily activities and may require rest.
Lowered Blood Cell Counts: Dacarbazine can reduce the production of blood cells in the bone marrow, leading to lower counts of red blood cells (anemia), white blood cells (increased risk of infection), and platelets (increased risk of bleeding). Blood tests are frequently performed to monitor these counts, and treatments may be adjusted accordingly.
Flu-Like Symptoms: Some people may develop flu-like symptoms, such as fever, chills, and muscle aches, after Dacarbazine treatment.
Liver and Kidney Function: Dacarbazine can affect liver and kidney function, leading to elevated liver enzyme levels and changes in kidney function. Regular monitoring of liver and kidney function is essential during treatment.
Skin Reactions: Skin reactions, including rash and itching, can occur in some individuals receiving Dacarbazine.
Infertility: Dacarbazine may cause temporary or permanent infertility, particularly in males. It is important to discuss fertility preservation options with a healthcare provider before starting treatment if fertility preservation is a concern.
Allergic Reactions: Although rare, severe allergic reactions to Dacarbazine can occur. Signs of an allergic reaction may include rash, itching, swelling, dizziness, or difficulty breathing. Seek immediate medical attention if these symptoms occur.

Frequently asked questions (FAQs) about Dacarbazine for Injection USP:

What is Dacarbazine for Injection USP used to treat?

Dacarbazine is used to treat various types of cancer, including metastatic melanoma and Hodgkin’s lymphoma. It is often part of combination chemotherapy regimens.

How does Dacarbazine for Injection USP work in cancer treatment?

Dacarbazine works by damaging the DNA of cancer cells, preventing their growth and replication. This ultimately leads to the shrinkage of tumors and the slowing down of cancer progression.

Is Dacarbazine for Injection USP a cure for cancer?

Dacarbazine is not a cure for cancer, but it is an important tool in cancer treatment. It can help control the disease, reduce symptoms, and improve survival rates when used in appropriate cases.

What are the common side effects of Dacarbazine for Injection USP?

Common side effects include nausea, vomiting, fatigue, lowered blood cell counts (anemia, decreased white blood cell and platelet counts), flulike symptoms, liver and kidney function changes, and skin reactions.

Are there any serious side effects I should be aware of?

Yes, serious side effects can include severe allergic reactions, which are rare but require immediate medical attention. It’s important to report any unusual or severe side effects to your healthcare provider.

Can I continue working and maintaining my daily activities while on Dacarbazine treatment?

Fatigue is a common side effect, so you may need to adjust your daily activities. It’s essential to discuss your specific situation with your healthcare provider, as they can provide guidance on managing side effects.

Is Dacarbazine for Injection USP safe during pregnancy or breastfeeding?

Dacarbazine can harm an unborn baby, so it is not recommended during pregnancy. It may also pass into breast milk, so breastfeeding is usually discouraged during treatment.

How is Dacarbazine for Injection USP administered?

Dacarbazine is typically administered intravenously (through a vein) by a healthcare professional. The dosage and treatment schedule are determined by your oncologist based on your specific cancer diagnosis and overall health.

Can I drink alcohol while on Dacarbazine treatment?

It’s generally advisable to avoid alcohol during cancer treatment, as it may interact with medications and exacerbate certain side effects. Consult your healthcare provider for personalized advice.

Is Dacarbazine for Injection USP covered by insurance?

Insurance coverage for Dacarbazine may vary depending on your policy and the specific indication for which it is prescribed. It’s advisable to check with your insurance provider or healthcare team for details on coverage.

Are there any dietary restrictions while on Dacarbazine treatment?

Your healthcare provider may recommend dietary modifications, such as a lowfiber or bland diet, to manage nausea and digestive symptoms. Discuss dietary guidelines with your provider.

Can I participate in clinical trials while taking Dacarbazine?

Your healthcare provider can discuss the possibility of participating in clinical trials as part of your cancer treatment plan. Clinical trials may offer access to innovative treatments and therapies.

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

Dacarbazine 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 Dacarbazine 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