Maball 500 (Rituximab) 500 mg/50 mL Cold chain · Storage +2…+8 °C

Indicated for CD20-positive conditions:

• 🩸 Non-Hodgkin’s Lymphoma (NHL): Follicular lymphoma and Diffuse Large B-Cell Lymphoma (DLBCL).
• 🩸 Chronic Lymphocytic Leukemia (CLL): First-line and relapsed/refractory treatment.
• 🦴 Rheumatoid Arthritis (RA): Moderate to severe active RA in patients with inadequate response to TNF inhibitors.
• Granulomatosis with Polyangiitis (GPA).

Packaging: 50 ml Vial (Concentration 10 mg/ml = Total 500 mg).

⚠️ ADMINISTRATION & SAFETY:

• 💉 IV Infusion Only: Must be administered via a dedicated line. NEVER administer as an IV push or bolus.
• 💊 Premedication: Antipyretics (e.g., paracetamol) and antihistamines (e.g., diphenhydramine) must be given before each infusion to reduce reactions.
• ⏱ Rate: Infusion starts slowly and rate is increased gradually if well-tolerated.

• Active, severe infections (e.g., tuberculosis, sepsis).
• Severe heart failure (NYHA Class IV).
• Known hypersensitivity to murine proteins.
• Pregnancy and breastfeeding (unless benefit outweighs risk).

Critical monitoring required for:

• 🚨 Infusion-Related Reactions (IRRs): Fever, chills, rigor, hypotension (very common during the first dose).
• 🦠 Infections: Reactivation of Hepatitis B virus (screening is mandatory before starting therapy).
• 📉 Hematologic: Neutropenia, leukopenia.
• PML (Progressive Multifocal Leukoencephalopathy) - rare but serious.