Nepofer

27.2 mg/5 ml IV Infusion Parenteral Iron Preparations
Ferric Pyrophosphate Citrate · Incepta Pharmaceuticals Ltd.
EN বাং
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এই ওষুধটি শরীরে আয়রনের ঘাটতি পূরণ করে। এটি রক্তস্বল্পতা প্রতিরোধ ও চিকিৎসার জন্য ব্যবহার করা হয় এবং নতুন রক্তকণিকা তৈরিতে সাহায্য করে। ডাক্তারের পরামর্শে এটি গর্ভাবস্থায় ও স্তন্যদানকালে ব্যবহার করা যেতে পারে।

Indications

Ferric Pyrophosphate Citrate is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Description

Ferric Pyrophosphate Citrate solution is a mixed-ligand iron complex in which iron (III) is bound to pyrophosphate and citrate. Ferric Pyrophosphate Citrate solution is a clear, slightly yellow-green color sterile solution containing 27.2 mg iron (III) per 5 mL. Each ampoule contains
  • Iron (7.5-9.0% w/w)
  • Citrate (15-22% w/w)
  • Pyrophosphate (15-22% w/w)
  • Phosphate (< 2% w/w)
  • Sodium (18-25% w/w)
  • Sulfate (20-35%)
One ampoule is added to 2.5 gallons (9.46 L) of bicarbonate concentrate.

Dosage & Administration

Important:
Do not take any medication without a doctor's prescription. Self-medication can be dangerous.
Inspect Ferric Pyrophosphate Citrate ampoule for signs of precipitation prior to mixing with the bicarbonate concentrate. Ferric Pyrophosphate Citrate should only be added to the bicarbonate concentrate and should not be added to acid concentrate mixtures. Add Ferric Pyrophosphate Citrate to bicarbonate concentrate used for generation of hemodialysate. The final concentration of iron (III) in the final hemodialysate is 2 micromolar (110 mcg/L). Multiple ampoules can be added to the master bicarbonate mix at each center at a ratio of one ampoule to each 2.5 gallons of bicarbonate concentrate.

Administer Ferric Pyrophosphate Citrate to patients at each dialysis procedure for as long as patients are receiving maintenance hemodialysis therapy for CKD.

Hemodialysis solutions should be used within 24 hours of the preparation of the Ferric Pyrophosphate Citrate /bicarbonate concentrate mixture.

Interaction

Formal drug interaction studies have not been performed for Ferric Pyrophosphate Citrate.

Side Effects

The most common side effects are headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

Pregnancy & Lactation

Pregnant women Category C. Lactating mothers It is not known whether Ferric Pyrophosphate Citrate is present in human milk or not.

Precautions & Warnings

Hypersensitivity Reactions: Anaphylactic-type reactions, shock, hypotension, loss of consciousness and collapse can occur. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until he/she is clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions.

Iron laboratory testing: Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.

Overdose Effects

No data are available regarding overdose of Ferric Pyrophosphate Citrate.

Storage Conditions

Keep in a cool and dry place, away from light. Keep out of reach of children.

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