Monofer 100; 500 and 1 000 mg Solution for injection/infusion.
PDF Leaflet Revision Date: 20 October 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of iron deficiency when oral iron is ineffective or not tolerated.
Dosage (summary)
Individualized based on iron need; up to 20 mg/kg body weight in a single infusion.
Special Populations
- Hepatic impairment
- Pregnancy
- Elderly
Pregnancy & Breastfeeding
Use in pregnancy only if necessary; low transfer to breast milk.
Key Drug Interactions
- Oral iron absorption reduced
- May cause falsely elevated serum bilirubin
Contraindications
- Hypersensitivity to ferric derisomaltose
- Non-iron deficiency anemia
- Iron overload
Common side effects
- Hypersensitivity reactions
- Headache
- Nausea
- Injection site reactions
Counselling Points
- Observe for 30 mins post-injection
- Avoid oral iron for 5 days post-injection
- Report any severe reactions immediately
Serious warnings
- Risk of anaphylactic reactions
- Monitor for hypersensitivity
- Avoid in ongoing bacteraemia
Important Disclaimer
The Monofer 100; 500 and 1 000 mg Solution for injection/infusion. professional information leaflet below is the property of Acino Pharma and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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