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MESNA injection, solution


  1. Patient Information
  2. Mesna Injection May Cause Serious Side Effects, Including:
  3. Active Ingredient:
  4. Mesna Injection:
  5. Revised: 1/2019document Id:

Patient Information 

Mesna injection can cause serious allergic reactions and skin reactions.These serious reactions can happen the first time you are treated with mesna injection or after several months of treatment with mesna injection. Stop treatment with mesna injection and go to the nearest hospital emergency room right away if you develop any of the symptoms listed below:

  • fever
  • swelling of your face, lips, mouth, or tongue
  • trouble breathing or wheezing
  • itching
  • burning
  • skin rash or hives
  • skin redness or swelling
  • skin blisters or peeling
  • feel lightheaded or faint
  • feel like your heart is racing
  • nausea
  • vomiting
  • joint or muscle aches
  • mouth sores

Mesna injection is a prescription medicine used to reduce the risk of inflammation and bleeding of the bladder (hemorrhagic cystitis) in people who receive ifosfamide (a medicine used to treat cancer).

Mesna injection is not for use to reduce the risk of blood in the urine (hematuria) due to other medical conditions.

Do not take mesna tablets or receive mesna injection by intravenous (IV) infusion ifyou are allergic to mesna or any of the ingredients in mesna injection.

  • Mesna is given on the same day that you receive ifosfamide.
  • Mesna can be given by an intravenous (IV) infusion into a vein or tablets taken by mouth.
  • You will receive mesna in one of two ways:
    • Mesna intravenous (IV) infusion into a vein at the time you receive ifosfamide and 4 and 8 hours after you receive ifosfamide,OR
    • Mesna intravenous (IV) infusion into a vein at the time you receive ifosfamide and mesna tablets taken by mouth 2 and 6 hours after you receive ifosfamide.
  • Take mesna tablets at the exact times and the exact dose your healthcare provider tells you to take it.
  • During treatment with mesna intravenous (IV) infusion or mesna tablets, you should drink 4 to 8 cups of liquid (1 to 2 liters) each day.
  • Tell your healthcare provider if you:
    • vomit within 2 hours of taking mesna tablets by mouth
    • miss a dose of mesna tablets
    • have pink or red colored urine

Mesna Injection May Cause Serious Side Effects, Including: 

  • Store at 20 to 25 C (68 to 77 F).

Keep mesna injection and all medicines out of the reach of children.

General information about the safe and effective use of mesna injection.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mesna injection for a condition for which it was not prescribed. Do not give mesna injection to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mesna injection that is written for health professionals.

Active Ingredient: 

mesna

Inactive ingredients:

Mesna Injection: 

edetate disodium, sodium hydroxide, and benzyl alcohol as a preservative.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Athenex
Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in India
2019 Athenex.

Revised: January 2019

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 70860-209-10

Mesna Injection

1 gram per 10 mL (100 mg per mL)

Rx only

For Intravenous Use

10 mL Multi-Dose Vial

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label
MESNA
mesna injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70860-209
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
mesna(UNII: NR7O1405Q9) (2-MERCAPTOETHANESULFONIC ACID - UNII:VHD28S0H7F)mesna100 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
edetate disodium(UNII: 7FLD91C86K)
benzyl alcohol(UNII: LKG8494WBH)
sodium hydroxide(UNII: 55X04QC32I)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70860-209-101 in 1 CARTON02/28/2018
110 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:70860-209-1110 in 1 CARTON02/28/2018
210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20699202/28/2018
Labeler -Athenex Pharmaceutical Division, LLC. (080318964)

Revised: 1/2019document Id: 

078ad786-0d72-481c-9263-915e70878680Set id: 614d0da0-ebcc-4055-a385-645bfe8c26e3Version: 2Effective Time: 20190131Athenex Pharmaceutical Division, LLC.



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