Unifer 100 mg/5 ml (IV Injection or Infusion)

5 ml ampoule: ৳ 326.00

Medicine Details

Category Details
Generic Iron sucrose
Company Ziska pharmaceuticals ltd

Indications

  • Treatment of Unifer deficiency
  • Rapid Unifer supply
  • Patients unable to tolerate oral Unifer therapy
  • Active inflammatory bowel disease
  • Non-dialysis dependent-chronic kidney disease patients
  • Hemodialysis dependent-chronic kidney disease patients
  • Peritoneal dialysis dependent-chronic kidney disease patients
  • Patients undergoing surgical procedures
  • Patients donating blood
  • Postpartum patients

Pharmacology

  • Therapeutic class: haematinic
  • Color: brown
  • Aqueous, sterile, complex of Polynuclear Iron (III) Hydroxide in Sucrose
  • Approximately 30% Sucrose w/v
  • pH: 10.5-11.1
  • Dissociation into Iron and Sucrose by the reticuloendothelial system
  • Iron transfer to liver and bone marrow
  • Ferritin binding and sequestering of Iron
  • Iron binding to plasma transferrin
  • Transferrin synthesis and ferritin production influenced by iron levels
  • Elimination half-life: 6 hours
  • Total clearance: 1.2 L/h
  • Non-steady state apparent volume of distribution: 10.0 L
  • Steady state apparent volume of distribution: 7.9 L

Dosage

  • Adult dosage: 5-10 ml Iron Sucrose Injection once to three times a week
  • Adult dosage (iron content): 100-200 mg
  • Children dosage: Limited data, cautious usage
  • Children dosage (iron content): Not to exceed 0.15 ml Iron Sucrose Injection per kg body weight once to three times per week
  • Test dose before therapeutic dose administration

Administration

  • Intravenous injection
  • Undiluted slow intravenous injection at recommended rate
  • Maximum dose per injection: 10 ml (200 mg Iron)
  • Test dose before therapeutic dose: 1 ml (20 mg Iron) in adults
  • Infusion by drip infusion in diluted form
  • Infusion time based on Iron content
  • Test dose before therapeutic dose in new patients

Interaction

  • No studied drug-drug interactions with Unifer
  • Contraindicated concomitant use with oral iron preparations
  • 5-day interval advised between oral Unifer therapy and last injection

Contraindications

  • Iron overload
  • Known hypersensitivity to Iron Sucrose or its components
  • Anaemia not caused by Iron deficiency
  • History of allergic disorders, asthma, eczema, anaphylaxis, liver disease, infections

Side Effects

  • Adverse reactions: hypotension, cramps, nausea, headache, vomiting, diarrhea
  • Various symptoms related to different body systems
  • Hypersensitivity reactions: wheezing, dyspnea, rashes, pruritus
  • Anaphylactoid reactions

Pregnancy & Lactation

  • Pregnancy Category-B
  • Limited data on excretion in human milk
  • Caution in lactating women

Precautions & Warnings

  • Periodic monitoring of hematologic and haematinic parameters
  • Caution with hypersensitivity reactions
  • Caution with administration to nursing women
  • Monitoring of Unifer parameters for overload
  • Caution with hypotension in hemodialysis patients

Use in Special Populations

  • Safety and effectiveness not established in pediatric patients
  • No overall differences in safety observed between elderly and younger subjects
  • Injection into dialyser
  • Specific dosages for chronic kidney disease patients

Overdose Effects

  • Accumulation of Iron in storage sites leading to hemosiderosis
  • Monitoring of Iron parameters for recognition of accumulation
  • Symptoms associated with overdosage

Therapeutic Class

  • Parenteral Iron Preparations

Storage Conditions

  • Store in cool and dry place (15°C-30°C)
  • Protected from light
  • Do not freeze

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