Fematos 500 mg/10 ml (IV Injection or Infusion)

10 ml vial: ৳ 700.00

Medicine Details

Category Details
Generic Ferric carboxymaltose
Company General pharmaceuticals ltd
Also available as
Fematos 100 mg injection Fematos 1 gm injection

Indications

  • Treatment of iron deficiency anaemia in adult patients
  • Intolerance to oral iron
  • Non-dialysis dependent chronic kidney disease

Description

  • Colloidal iron (III) hydroxide
  • Complex with Carboxymaltose
  • Carbohydrate polymer

Dosage & Administration

  • Stepwise approach
  • Determination of individual iron need
  • Calculation and administration of iron dose(s)
  • Post-iron repletion assessments
  • Posology based on body weight and haemoglobin level
  • Maximum individual iron dose(s) calculation and administration
  • Re-assessment by clinician
  • Re-assessment of Hb level

Interaction

  • Lack of formal drug interaction studies

Contraindications

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

Side Effects

  • Infrequent and mild side effects
  • Nausea
  • Headache
  • Dizziness
  • Hypertension
  • Injection site reactions
  • Nausea
  • Alanine aminotransferase increased
  • Hypophosphataemia
  • Hypersensitivity
  • Dysgeusia
  • Tachycardia
  • Hypotension
  • Flushing
  • Dyspnoea
  • Dyspepsia
  • Abdominal pain
  • Constipation
  • Diarrhea
  • Pruritus
  • Urticaria
  • Erythema
  • Rash
  • Myalgia
  • Back pain
  • Arthralgia
  • Muscle spasms
  • Pyrexia
  • Fatigue
  • Chest pain
  • Oedema peripheral
  • Chills
  • Aspartate aminotransferase increased
  • Gamma glutamyl transferase increased
  • Blood lactate dehydrogenase increased
  • Blood alkaline phosphatase increased
  • Anaphylactoid reactions
  • Loss of consciousness
  • Anxiety
  • Phlebitis
  • Syncope
  • Presyncope
  • Bronchospasm
  • Flatulence
  • Angioedema
  • Pallor
  • Face oedema
  • Rigors
  • Malaise
  • Influenza like illness

Pregnancy & Lactation

  • Limited data on pregnant women
  • Animal data suggesting placental barrier crossing
  • Influence on fetal skeletal development
  • Unlikely risk during breastfeeding

Precautions & Warnings

  • Serious hypersensitivity reactions
  • Anaphylactic-type reactions
  • Hypersensitivity monitoring
  • Hypertension monitoring
  • Laboratory test alterations

Use in Special Populations

  • Maximum daily injection dose in haemodialysis-dependent chronic kidney disease patients
  • Not recommended in children under 14 years

Overdose Effects

  • Risk of iron accumulation
  • Monitor iron parameters
  • Consider use of iron chelator

Therapeutic Class

  • Parenteral Iron Preparations

Storage Conditions

  • Cool and dry storage below 30°C
  • Away from light
  • Do not freeze
  • Keep out of the reach of children

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