Ferisen 100 mg/2 ml (IV Injection or Infusion)

Indications

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

Description

• Colloidal iron (III) hydroxide in complex with Carboxymaltose
• Carbohydrate polymer-based iron release

Dosage & Administration

• Stepwise approach to posology determination
• Individual iron need determination based on body weight and haemoglobin level
• Calculation and administration of the iron dose(s)
• Maximum individual iron dose(s)
• Post-iron repletion assessments by the clinician

Interaction

• No formal drug interaction studies performed

Contraindications

• Hypersensitivity to active substance or any excipients
• Serious hypersensitivity to other parenteral iron products
• Other types of anaemia not attributed to iron deficiency
• Evidence of iron overload or disturbances in iron utilisation

Side Effects

• Mild and infrequent side effects
• Common side effects including nausea, headache, dizziness
• Uncommon side effects like dysgeusia, tachycardia, hypotension
• Rare side effects such as anaphylactoid reactions, loss of consciousness

Pregnancy & Lactation

• Lack of adequate and well-controlled trials in pregnant women
• Animal data suggest potential influence on fetal skeletal development
• Unlikely risk to breast-fed child based on limited data

Precautions & Warnings

• Reported serious hypersensitivity reactions
• Hypertension monitoring post administration
• Possible overestimation of serum iron and transferrin bound iron
• Necessity of available personnel and therapies for serious hypersensitivity reactions treatment

Use in Special Populations

• Special dosage considerations for patients with haemodialysis-dependent chronic kidney disease
• Not recommended for children under 14 years

Overdose Effects

• Potential accumulation of iron in storage sites
• Monitoring of iron parameters such as serum ferritin and transferrin saturation
• Consideration of standard medical practice for iron accumulation treatment

Therapeutic Class

• Parenteral Iron Preparations

Storage Conditions

• Store in cool and dry place below 30°C
• Avoid exposure to light and freezing
• Keep out of reach of children

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