Pamidronate Disodium (Lyophilized) 30 MG, 60 MG, 90 MG

Categories:Oncology, Oncology Supportive Care SKU: 00002-91

Description

PRODUCT DESCRIPTION:

Pamidronate Disodium is a bisphosphonate indicated for the treatment of hypercalcemia of malignancy, osteolytic bone metastases, and Paget’s disease.

It inhibits bone resorption by reducing osteoclast activity, helping restore calcium balance and prevent skeletal-related events in cancer patients.

Formulation & Presentation:

Dosage Form: Sterile Injectable
Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
Available Strengths:
- 30 MG (Lyophilized)
- 60 MG (Lyophilized)
- 90 MG (Lyophilized Vial)
Route of Administration: Intravenous (IV) Slow Injection/ Infusion after appropriate reconstitution or as per clinical indication and severity. Reconstituted as per protocol Intravenous infusion. To be administered under supervision of a qualified oncologist or day-care oncology units. (As per physician’s discretion or decision) Administered as continuous infusion, typically as part of combination chemotherapy regimens

Therapeutic Indications:

Hypercalcemia of malignancy
Bone pain and osteolytic lesions due to metastatic breast cancer or multiple myeloma
Paget’s disease of bone

Side Effects:

COMMON:
- Fever,
- Nausea
- Fatigue
- Vomiting,
- Flu-like symptoms
- Myalgia
SERIOUS (RARE):
- Osteonecrosis of the jaw
- Renal toxicity
- Severe hypocalcemia
- Arrhythmias
PRECAUTIONS:
- Monitor renal function and serum electrolytes regularly
- Adequate hydration before administration is recommended
- Avoid concurrent use with nephrotoxic drugs
- Use cautiously in patients with hepatic or renal impairment

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HSN Code: To be assigned per international classification & import jurisdiction
Weight: Approx. 40g per carton (with packaging)
Dimensions: 15 x 1 x 8 CMS
Shelf Life: 24–36 months under recommended storage conditions from date of manufacture (subject to country-specific guidelines)
Storage:
- Store below 25°C (Do not freeze)
- Lyophilized vial to be stored at room temperature below 25°C
- Does not require cold-chain logistics
- Protect from moisture and direct sunlight
- Use strictly as per label guidelines

Manufacturing Compliance: WHO-GMP Certified
Documentation: COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request)
Export Dossiers: Available in CTD/eCTD formats (COA, COPP included)
Stability: Compliant
MOQ: Negotiable (based on market & registration status)
Export Options: Private label, institutional supply, or branded export