tion if any signs or symptoms of a hypersensitivity reaction, including systemic anaphylactic reactions occur [See Warnings and Precautions (5.1)].
Advise the patient to take mesna at the exact time and in the exact amount as prescribed. [See Dosage and Administration (2.2)].
Mesna does not prevent hemorrhagic cystitis in all patients nor does it prevent or alleviate any of the other adverse reactions or toxicities associated with ifosfamide. Advise the patient to report to their healthcare provider if his/her urine has turned a pink or red color [See Dosage and Administration (2.3)].
Advise the patient to drink 1 to 2 liters of fluid each day during mesna therapy [See Dosage and Administration (2.3)].
Advise the patient that Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms and bullous and ulcerative skin and mucosal reactions have occurred with mesna. Advise the patient to report to their healthcare provider if signs and symptoms of these syndromes occur [See Warnings and Precautions (5.2)].
Manufactured by:
Agila specialties Private Limited
Bangalore -560076
India.
Issued: 04/2014
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MESNA
mesna injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76126-075
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESNA (UNII: NR7O1405Q9) (2-MERCAPTOETHANESULFONIC ACID - UNII:VHD28S0H7F) MESNA 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.25 mg in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH) 10.4 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76126-075-01 1 in 1 CARTON
1 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203364 07/19/2014
Labeler - AGILA SPECIALTIES PRIVATE LIMITED (650548014)
Registrant - AGILA SPECIALTIES PRIVATE LIMITED (650548014)
Establishment
Name Address ID/FEI Business Operations
AGILA SPECIALTIES PRIVATE LIMITED 676199117 Analysis(76126-075) , Manufacture(76126-075) , Sterilize(76126-075) , Pack(76126-075)
