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Celdaz (200mg / 500mg) - Dacarbazine For Injection

Celdaz contains dacarbazine, a chemotherapy medication used for treating various types of cancer including melanoma, Hodgkin’s lymphoma, and sarcoma. It works by interfering with the growth of cancer cells and slowing their spread.

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General Information:
Generic Name: Dacarbazine
Brand Name: Celdaz
Packing: Single-use vial
Strengths Available: 200mg / 500mg
Manufacturer: Celon Laboratories Ltd
Form: Lyophilized powder for injection (requires reconstitution)
Category: Antineoplastic / Alkylating Agent
Prescription Status: Prescription only (Rx)
Product Introduction:
Celdaz is a sterile, lyophilized powder for intravenous injection containing dacarbazine, an alkylating agent used in chemotherapy protocols. It is administered under strict medical supervision and is part of combination regimens for several malignancies.

Uses:
Celdaz is indicated for the treatment of the following cancers:
  1. Metastatic malignant melanoma
  2. Hodgkin’s lymphoma (usually in combination with other drugs like ABVD regimen)
  3. Soft tissue sarcomas
  4. Neuroblastoma
  5. Rhabdomyosarcoma
  6. Pancreatic islet cell carcinoma

Storage Instructions:
  1. Store below 25°C in a dry place
  2. Protect from light
  3. After reconstitution, the solution should be used immediately or as directed by handling guidelines
  4. Do not freeze the reconstituted solution

How It Works (Mechanism of Action):
Dacarbazine is a cytotoxic alkylating agent. It works by:
  1. Undergoing metabolic activation in the liver to form active methylating agents
  2. These agents alkylate DNA, causing cross-links and breaks
  3. This disrupts DNA replication and transcription, leading to cell cycle arrest and apoptosis of rapidly dividing tumor cells

Side Effects:
Common side effects:
  1. Nausea and vomiting
  2. Loss of appetite
  3. Fatigue
  4. Injection site pain
  5. Low white blood cell and platelet counts
  6. Flu-like symptoms (fever, chills, muscle aches)
Severe side effects:
  1. Bone marrow suppression (leading to infections, anemia, bleeding)
  2. Liver toxicity (elevated liver enzymes, jaundice)
  3. Severe allergic reactions (rash, hypotension, bronchospasm)
  4. Neutropenic sepsis
  5. Local tissue damage if extravasation occurs

Dosage (Typical Recommended Dose):
  1. For Hodgkin's disease: 150 mg/m² IV daily for 5 days every 28 days or 375 mg/m² every 15 days (in combination therapy)
  2. For melanoma or sarcoma: 2–4.5 mg/kg/day IV for 10 days every 28 days or per protocol
Dosage may vary based on patient weight, disease type, and combination protocols.

Method of Administration:
  1. Intravenous (IV) infusion only
  2. Reconstitute with sterile water or sodium chloride injection and further dilute in infusion fluid
  3. Administer via central line if possible to avoid extravasation
  4. Should be given under the supervision of a trained healthcare professional

Precautions:
  1. Monitor CBC (complete blood count) regularly during treatment
  2. Liver and renal function tests must be performed before and during therapy
  3. Use with extreme caution in patients with hepatic or renal impairment
  4. Contraindicated during pregnancy and breastfeeding
  5. Avoid live vaccines during therapy due to immunosuppression risk

Drug Interactions:
  1. Increased risk of toxicity with other myelosuppressive drugs
  2. Enhanced hepatic metabolism interactions with CYP1A2 inducers or inhibitors
  3. Avoid concomitant use with live vaccines and immunosuppressants without physician guidance

Allergies:
  1. Contraindicated in individuals with a known hypersensitivity to dacarbazine
  2. Allergic reactions may manifest as rash, fever, wheezing, hypotension
  3. Discontinue immediately if signs of hypersensitivity occur

Overdose Information:
  1. Symptoms may include severe bone marrow suppression, liver damage, and GI toxicity
  2. There is no specific antidote
  3. Treatment is supportive: hospitalization, blood transfusions, antibiotics for infections
  4. Seek emergency medical attention immediately

Missed Dose Instructions:
  1. If a scheduled dose is missed, consult the healthcare provider immediately
  2. The dose should be rescheduled based on the clinical situation
  3. Do not self-administer or double the next dose

Additional Notes:
  1. Dacarbazine is a vesicant – care must be taken to avoid leakage outside the vein during infusion
  2. Requires protective handling due to its cytotoxic nature
  3. Patients should be counseled on infection signs, bleeding, and side effect reporting
  4. Periodic tumor response assessments should be conducted during treatment

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