Manufacturer
S.C. Sindan-Pharma S.R.L.(ROMANIA)

Registraction Number
MAL10012446AZ

Content:

• Active Ingredient: Paclitaxel (6 mg/mL)
• Excipients: Polyoxyl 35 castor oil (Macrogolglycerol ricinoleate 35) and anhydrous ethanol

Indications:
ACLIPAK is used for the treatment of:

• Ovarian carcinoma: First-line and second-line therapy for advanced metastatic carcinoma of the ovary.
• Breast carcinoma: Initial treatment of advanced or metastatic breast cancer, either in combination with trastuzumab or as a second-line therapy.
• Non-small cell lung carcinoma: First-line therapy in combination with a platinum compound or as a single agent.
• AIDS-related Kaposi's sarcoma: Treatment for patients with advanced AIDS-related Kaposi's sarcoma who have failed prior liposomal anthracycline therapy.

Instructions:

• Premedication: Before initiating ACLIPAK therapy, patients should receive premedication with glucocorticoids, antihistamines (anti-H1 and anti-H2), and cimetidine or ranitidine.
• Administration: The solution should be administered through an in-line filter with a microporous membrane with a mesh diameter of less than 0.22 μm.
• Storage: Store below 30°C, away from moisture and heat. Keep out of reach of children.