GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Infliximab Dry Powder for Injection (Lyophilized) 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Infliximab Dry Powder for Injection (Lyophilized) 100mg
Each vial contains
Infliximab ………………………...100mg
produced by recombinant DNA (r-dna) technology in Chinese hamster ovary(CHO)
Excipients………………………….. q.s..

THERAPEUTIC INDICATIONS:

Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor necrosis factor-alpha (TNF-a).TNF-a is a signaling protein involved in acute phase reaction and systemic inflammation.

CAUTION & SCHEDULE:

CAUTION: Keep all medicines reach out of children.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Store at 2 to 8°C (36° to 45°F) If solution freezes, bring to room temperature, allow sufficient time to solubilize
Dosage: Single Dose Vial.
As directed by the Physician.

Infliximab Dry Powder for Injection (Lyophilized) 100mg Technical Specification:

Product Name:
Infliximab Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:100mg
Dosage Form:Dry Powder for Injection (Lyophilized)
Route of Administration:For intravenous infusion after dilution.
Packing:vials
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antiflatulents
Indication: Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor necrosis factor-alpha (TNF-a).TNF-a is a signaling protein involved in acute phase reaction and systemic inflammation.
Storage:Store at 2 to 8°C (36° to 45°F) If solution freezes, bring to room temperature, allow sufficient time to solubilize

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Infliximab Dry Powder for Injection (Lyophilized) 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Infliximab Dry Powder for Injection (Lyophilized) 100mg
    Each vial contains
    Infliximab …………………………100mg
    produced by recombinant DNA (r-dna) technology in Chinese hamster ovary(CHO)
    Excipients………………………….. q.s.

THERAPEUTIC INDICATIONS:

Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor necrosis factor-alpha (TNF-a).TNF-a is a signaling protein involved in acute phase reaction and systemic inflammation.

CAUTION & SCHEDULE:

CAUTION:
Keep all medicines reach out of children.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage:Store at 2 to 8°C (36° to 45°F) If solution freezes, bring to room temperature, allow sufficient time to solubilize Dosage:Single Dose Vial.
As directed by the Physician.