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

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, calculation, and administration of iron dose(s)
• Maximum recommended cumulative dose of Ferric Carboxymaltose is 1000 mg of iron per week
• Post-iron repletion assessments by the clinician

Interaction

• No formal drug interaction studies performed with Hemorise

Contraindications

• Hypersensitivity to the active substance or any excipients
• Anaemia not attributed to iron deficiency
• Evidence of iron overload or disturbances in the utilisation of iron

Side Effects

• Infrequent and mild side effects
• Common side effects: nausea, headache, dizziness
• Uncommon side effects: hypersensitivity, tachycardia, diarrhea
• Rare side effects: anaphylactoid reactions, loss of consciousness

Pregnancy & Lactation

• No adequate and well-controlled trials in pregnant women
• Benefit/risk evaluation required before use during pregnancy
• Unlikely to represent a risk to the breast-fed child based on limited data

Precautions & Warnings

• Serious hypersensitivity reactions reported
• Monitor patients for signs and symptoms of hypersensitivity
• Transitory elevations in systolic blood pressure may occur
• Laboratory test alterations within 24 hours of administration

Use in Special Populations

• Single maximum daily injection dose of 200 mg iron in haemodialysis-dependent chronic kidney disease patients
• Not recommended in 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 such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation

Therapeutic Class

• Parenteral Iron Preparations

Storage Conditions

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

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