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MonoFer IV Iron Injection
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MonoFer 100mg/ml is a prescription-only intravenous iron injection containing ferric derisomaltose, indicated for the treatment of confirmed iron deficiency where oral iron is ineffective, cannot be used, or where rapid iron delivery is clinically required. Each 1ml contains 100mg iron for intravenous administration by appropriately trained healthcare professionals only. Manufactured by Pharmacosmos. Supplied through AestheticsRx Pharma — a GPhC-registered distance selling pharmacy.
Instructions:
1. Confirm suitability: Verify the prescription, laboratory-confirmed iron deficiency, calculated iron requirement, allergy history and relevant contraindications before treatment.
2. Ensure emergency facilities: Only administer where staff trained to manage anaphylaxis and full resuscitation facilities are immediately available.
3. Check the product: Inspect the vial/ampoule, batch, expiry date and solution. Only use a homogeneous, sediment-free solution.
4. Administer intravenously only: Give by IV injection, IV infusion or into the venous limb of a haemodialysis circuit as prescribed and according to the current SmPC. Do not exceed the prescribed dose or recommended administration rate.
5. Dilute correctly: If dilution is required, use only sterile 0.9% sodium chloride as specified in the SmPC. Do not mix with other medicines.
6. Monitor carefully: Observe for hypersensitivity, breathing difficulty, rash, swelling, hypotension or other adverse reactions. Stop administration immediately if a serious reaction is suspected.
7. Observe for 30 minutes: Monitor the patient for at least 30 minutes after every MonoFer administration, with emergency treatment available.
8. Single use and disposal: Do not reuse opened containers. Dispose of remaining medicine, needles, cannulas and other clinical waste according to local procedures.
Description
MonoFer 100mg/ml is a prescription-only intravenous iron preparation containing ferric derisomaltose, used for the treatment of confirmed iron deficiency. Each 1ml contains 100mg of iron, delivered intravenously in a controlled-release iron-carbohydrate complex designed to provide bioavailable iron to the body’s iron-binding proteins.
MonoFer is indicated where oral iron preparations are ineffective, cannot be used, or where there is a clinical need to deliver iron rapidly. The diagnosis of iron deficiency must always be based on appropriate laboratory testing before treatment begins.
Marketing authorisation held by Pharmacosmos A/S. UK company: Pharmacosmos UK Limited. Supplied by AestheticsRx Pharma — a GPhC-registered distance selling pharmacy — to verified UK healthcare professionals and prescribers only.
Licensed Indications
MonoFer is indicated for the treatment of iron deficiency:
- When oral iron preparations are ineffective
- When oral iron preparations cannot be used
- Where there is a clinical need to deliver iron rapidly
The diagnosis must be supported by appropriate laboratory tests. Assessment may include haemoglobin, serum ferritin, transferrin saturation, and other clinically appropriate iron-status investigations. For acute blood loss, haemoglobin may be sufficient as the diagnostic laboratory test according to the SmPC.
How It Works
MonoFer contains iron in a complex with derisomaltose. The formulation is designed to provide a controlled release of bioavailable iron to iron-binding proteins within the body. Following administration, the iron can contribute to replenishment of haemoglobin, ferritin, and physiological iron stores.
Key Benefits
- Prescription-only intravenous iron preparation containing ferric derisomaltose
- 100mg iron per ml
- Used for confirmed iron deficiency
- Suitable where oral iron is ineffective or cannot be used
- May be used where rapid iron delivery is clinically required
- Can be given by intravenous injection or infusion
- Can be administered into the venous limb of a haemodialysis circuit where appropriate
- Professional healthcare use only — not suitable for self-administration
Product Details
- • Product name: MonoFer 100mg/ml Solution for Injection/Infusion
- • Active ingredient: Ferric derisomaltose
- • Strength: 100mg iron/ml
- • Pharmaceutical form: Solution for injection/infusion
- • Appearance: Dark brown, non-transparent solution
- • Route: Intravenous use only
- • Legal category: Prescription-only medicine (POM)
- • Marketing authorisation holder: Pharmacosmos A/S
- • UK company: Pharmacosmos UK Limited
- • Use: Single use
MonoFer is available in a range of vial and ampoule sizes. Always check the physical product supplied for the exact container volume, iron content, pack quantity, batch number, and expiry date.
Route of Administration & Dose Information
MonoFer must only be administered intravenously. It may be administered by intravenous bolus injection, intravenous infusion, or into the venous limb of a haemodialysis circuit where clinically appropriate. It must not be administered by any unsupported route.
The patient’s total iron requirement must be calculated individually. According to the current SmPC:
- The total weekly dose should not exceed 20mg iron/kg body weight
- A single infusion should not exceed 20mg iron/kg
- A single intravenous bolus injection should not exceed 500mg iron
If the total required dose exceeds 20mg/kg, treatment should be divided into separate administrations with an interval of at least one week. Dose calculation and administration must always follow the prescription and current SmPC.
Contraindications
MonoFer must not be used in patients with:
- Hypersensitivity to ferric derisomaltose, MonoFer, or its excipients
- Known serious hypersensitivity to another parenteral iron preparation
- Anaemia not caused by iron deficiency
- Iron overload or disorders affecting iron utilisation
- Decompensated liver disease
Important Safety Warnings
Hypersensitivity & Anaphylaxis: Parenteral iron preparations can cause serious hypersensitivity reactions, including potentially fatal anaphylactic or anaphylactoid reactions — even in patients who have previously received parenteral iron without complications. MonoFer must only be administered where staff trained in anaphylaxis management are immediately available, full resuscitation facilities can be assured, appropriate emergency medicines are accessible, and the patient can be monitored appropriately. The patient must be observed for at least 30 minutes after every administration.
Infection Precaution: Parenteral iron should be used cautiously in patients with acute or chronic infection. MonoFer should not be used in patients with ongoing bacteraemia. An individual clinical benefit-risk assessment is required where infection is present.
Extravasation Warning: Care must be taken to avoid paravenous leakage. Extravasation can cause irritation, pain, inflammation, and potentially long-lasting brown skin discolouration. Administration should be stopped immediately if extravasation occurs.
Purchase & Resuscitation Facilities Declaration
By purchasing MonoFer, you confirm and accept that full resuscitation facilities are available on site where this medicine will be administered. By purchasing this product, you confirm that:
- MonoFer will only be administered by an appropriately trained healthcare professional
- Staff trained to recognise and manage anaphylactic reactions are immediately available
- Full cardiopulmonary resuscitation facilities are available on site
- Appropriate emergency medicines and equipment are immediately accessible
- The patient can be appropriately monitored during administration
- The patient will be observed for at least 30 minutes following administration
- Appropriate clinical assessment and laboratory confirmation of iron deficiency will take place before treatment
Do not purchase or administer MonoFer if appropriately trained personnel and full resuscitation facilities cannot be assured.
Professional Use Only
MonoFer is intended for professional healthcare use only. It should only be prescribed and administered by appropriately qualified healthcare professionals with suitable competency in patient assessment, iron-deficiency diagnosis, dose calculation, intravenous medicine administration, hypersensitivity recognition, anaphylaxis management, and emergency resuscitation.
MonoFer must not be self-administered.
Supplied exclusively by AestheticsRx Pharma — a GPhC-registered distance selling pharmacy serving verified healthcare professionals and prescribers across the UK.
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