Fematos 1 gm/20 ml (IV Injection or Infusion)

20 ml vial: ৳ 1,300.00

Medicine Details

Category Details
Generic Ferric carboxymaltose
Company General pharmaceuticals ltd
Also available as
Fematos 100 mg injection Fematos 500 mg injection

Indications

  • Treatment of iron deficiency anaemia in adult patients with intolerance to oral iron or non-dialysis dependent chronic kidney disease

Description

  • Colloidal iron (III) hydroxide in complex with Carboxymaltose, a Carbohydrate polymer that releases iron

Dosage & Administration

  • Stepwise approach for determination of individual iron need and administration of Ferric Carboxymaltose
  • Posology based on patient's body weight and haemoglobin level
  • Calculation and administration of the maximum individual iron dose(s)
  • Post-iron repletion assessments by the clinician

Interaction

  • Formal drug interaction studies have not been performed

Contraindications

  • Hypersensitivity to the active substance or any of its excipients
  • Serious hypersensitivity to other parenteral iron products
  • Anaemia not attributed to iron deficiency
  • Evidence of iron overload or disturbances in the utilisation of iron

Side Effects

  • Infrequent and mild side effects such as nausea, headache, dizziness, hypertension, injection site reactions, alanine aminotransferase increased, hypophosphataemia
  • Uncommon side effects including hypersensitivity, dysgeusia, tachycardia, hypotension, flushing, dyspnoea, abdominal pain, constipation, diarrhea, Pruritus, urticaria, erythema, rash, myalgia, back pain, arthralgia, muscle spasms, Pyrexia, fatigue, chest pain, edema peripheral, chills, aspartate aminotransferase increased, gamma glutamyl transferase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
  • Rare side effects like anaphylactoid reactions, loss of consciousness, anxiety, phlebitis, syncope, presyncope, bronchospasm, flatulence, angioedema, pallor, face edema, rigors, malaise, influenza like illness

Pregnancy & Lactation

  • No adequate and well-controlled trials in pregnant women
  • Animal data suggests potential influence on skeletal development in the fetus
  • Limited data on breast-feeding women suggest unlikely risk to the breast-fed child

Precautions & Warnings

  • Risk of serious hypersensitivity reactions
  • Monitor for signs and symptoms of hypersensitivity during and after administration
  • Transient elevations in systolic blood pressure may occur
  • Laboratory test alterations in the 24 hours following administration

Use in Special Populations

  • Restrictions in haemodialysis-dependent chronic kidney disease patients and children under 14 years

Overdose Effects

  • Excessive dosages may lead to accumulation of iron in storage sites potentially leading to hemosiderosis
  • Monitoring of iron parameters may assist in recognising iron accumulation and treatment according to standard medical practice may be necessary

Therapeutic Class

  • Parenteral Iron Preparations

Storage Conditions

  • Store in a cool and dry place below 30°C, away from light, and out of the reach of children

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