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Ferinject 50mg/ml 10ml Single Vial
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Ferinject 50mg/ml is a prescription-only intravenous iron medicine containing ferric carboxymaltose, with 500mg iron per 10ml single-use vial (50mg/ml). Indicated for the treatment of confirmed iron deficiency where oral iron is ineffective, cannot be used, or where rapid iron replacement is clinically required. For professional healthcare use only — must be administered intravenously by a trained healthcare professional in a suitable clinical environment. Supplied through AestheticsRx Pharma — a GPhC-registered distance selling pharmacy.
Instructions:
# Ferinject Injection 50mg/ml – 10ml Single Vial – Full Product Instructions
## Professional Use Instructions
Ferinject 50mg/ml must only be administered by an appropriately trained healthcare professional.
Each 10ml vial contains 500mg iron as ferric carboxymaltose.
It is a Prescription Only Medicine and must be used exactly as prescribed and in accordance with the current SmPC and local intravenous iron protocol.
**Do not self-administer.**
## Mandatory Purchase & Administration Requirement
**By purchasing Ferinject, you confirm that full resuscitation facilities are available on site.**
The purchaser accepts responsibility for ensuring that:
* Staff trained to evaluate and manage anaphylactic reactions are immediately available
* Full cardiopulmonary resuscitation facilities are available
* Appropriate emergency medicines and equipment are available
* The patient can be appropriately monitored
* The patient will be observed for at least 30 minutes after administration
* The treatment area is suitable for intravenous medicine administration
* The person administering Ferinject is appropriately trained and competent
**Do not administer Ferinject if these requirements cannot be met.**
## Before Administration
Before administering Ferinject:
* Confirm the patient’s identity
* Confirm a valid prescription
* Confirm the clinical indication
* Confirm iron deficiency using appropriate laboratory investigations
* Determine the patient's individual iron requirement
* Check haemoglobin and relevant iron-status results
* Review allergy history
* Review previous reactions to intravenous or parenteral iron
* Review current medicines
* Assess liver function where appropriate
* Assess infection status
* Consider phosphate status and hypophosphataemia risk
* Review pregnancy or breastfeeding status
* Confirm emergency and resuscitation facilities are immediately available
* Check the vial, batch number and expiry date
Inspect the vial before use.
Only use a sediment-free, homogeneous dispersion.
Do not use if the vial is damaged, contaminated, expired or appears abnormal.
## Dose Determination
The total iron requirement must be determined individually according to factors including:
* Body weight
* Haemoglobin level
* Degree of iron deficiency
* Clinical condition
* Previous iron replacement therapy
For adults and adolescents aged 14 years and over, the current SmPC states that a single intravenous injection must not exceed **15mg iron/kg body weight or 1,000mg iron**, whichever is lower.
For intravenous infusion, a single dose must not exceed **20mg iron/kg or 1,000mg iron**, whichever is lower.
The maximum recommended cumulative dose is generally **1,000mg iron per week**.
This single 10ml vial contains **500mg iron**.
The exact dose must always follow the prescription and current SmPC.
Route of Administration
Ferinject is for intravenous use only.
It may be given by:
* Intravenous injection
* Intravenous infusion
* Direct administration into the venous limb of a haemodialysis circuit, where appropriate
Do not administer:
* Intramuscularly
* Subcutaneously
Intravenous Injection
Ferinject may be administered undiluted by intravenous injection.
For doses above 200mg and up to 500mg, the current SmPC specifies an administration rate of **100mg iron per minute**.
Administration must follow the prescription, current SmPC and local IV iron protocol.
Intravenous Infusion
For intravenous infusion, Ferinject must only be diluted in sterile **0.9% sodium chloride solution**.
For a 500mg / 10ml dose, the current SmPC allows dilution with up to **100ml sterile sodium chloride 0.9%**, with a minimum administration time of **6 minutes**.
Ferinject should not be diluted below a concentration of 2mg iron/ml.
Do not mix with other intravenous medicines or alternative dilution solutions.
Monitoring During Administration
Monitor the patient carefully for signs and symptoms including:
* Rash
* Itching
* Flushing
* Dizziness
* Hypotension
* Hypertension
* Breathing difficulty
* Wheezing
* Chest symptoms
* Facial or throat swelling
* Sudden pain
* Collapse
* Other signs of intolerance or hypersensitivity
If hypersensitivity or intolerance occurs:
**Stop administration immediately and initiate appropriate emergency management.**
30-Minute Observation Requirement
Every patient must be observed for adverse reactions for at least **30 minutes following each Ferinject administration**.
Full emergency and resuscitation facilities must remain available during this period.
Do Not Use Ferinject If
Ferinject is contraindicated in patients with:
* Hypersensitivity to ferric carboxymaltose
* Hypersensitivity to any Ferinject ingredient
* Known serious hypersensitivity to another parenteral iron product
* Anaemia not caused by iron deficiency
* Evidence of iron overload
* Disorders affecting the utilisation of iron
Hypersensitivity Warning
Serious and potentially fatal anaphylactic reactions can occur with parenteral iron.
Risk may be increased in patients with:
* Known medicine allergies
* Severe asthma
* Eczema
* Atopic allergy
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Other immune or inflammatory conditions
A previous uneventful iron infusion does not eliminate the possibility of a future reaction.
Hypophosphataemia
Ferric carboxymaltose can cause hypophosphataemia.
Monitor serum phosphate where clinically appropriate, particularly in patients:
* Receiving repeated high doses
* Receiving prolonged treatment
* With recognised risk factors for hypophosphataemia
* Reporting worsening fatigue
* Reporting muscle pain
* Reporting bone pain
Persistent hypophosphataemia may require reassessment of treatment.
Extravasation Warning
Avoid paravenous leakage.
Extravasation can cause:
* Pain
* Irritation
* Inflammation
* Potentially long-lasting brown discolouration of the skin
If extravasation occurs, stop administration immediately and manage according to local clinical protocol.
Infection Warning
Parenteral iron should be used cautiously in patients with acute or chronic infection.
Treatment should generally be stopped in patients with ongoing bacteraemia.
An individual benefit-risk assessment should be completed where infection is present.
Pregnancy and Breastfeeding
Ferinject should only be used during pregnancy where clearly necessary following an individual benefit-risk assessment.
Where intravenous iron is required during pregnancy, treatment is generally more appropriate in the second or third trimester rather than the first trimester.
Pregnant patients require appropriate clinical assessment and monitoring.
Breastfeeding patients should also be assessed before treatment.
Possible Side Effects
Possible side effects include:
* Nausea
* Headache
* Dizziness
* Flushing
* High blood pressure
* Injection or infusion-site reactions
* Hypophosphataemia
* Vomiting
* Abdominal pain
* Constipation
* Diarrhoea
* Indigestion
* Rash
* Itching
* Hives
* Muscle pain
* Joint pain
* Back pain
* Fatigue
* Chills
* Fever
* Chest discomfort
* Low blood pressure
* Fast heart rate
Serious reactions may include:
* Anaphylaxis
* Severe hypersensitivity
* Angioedema
* Bronchospasm
* Collapse
* Loss of consciousness
* Kounis syndrome
* Severe hypophosphataemia
* Hypophosphataemic osteomalacia
Urgent medical treatment is required for serious reactions.
Post-Treatment Assessment
Iron status should be reassessed as clinically appropriate following treatment.
Further Ferinject should only be administered following reassessment and calculation of the patient's ongoing iron requirement.
Storage Instructions
* Do not store above 30°C
* Do not freeze
* Keep in the original packaging
* Keep out of sight and reach of children
* Do not use after the expiry date
Each vial is intended for single use only.
Disposal
Dispose of:
* Used vials
* Needles
* Syringes
* Cannulas
* Infusion equipment
* Remaining medicine
according to local sharps and clinical waste procedures.
Do not retain remaining product from an opened vial for later use.
Disclaimer
This information is provided for general professional product guidance and does not replace the prescription, current Ferinject SmPC, Patient Information Leaflet, IV iron training, local clinical protocols, pharmacist advice or professional judgement.
Always administer Ferinject exactly as prescribed and in accordance with current manufacturer guidance.
Description
Ferinject 50mg/ml is a prescription-only intravenous iron medicine containing ferric carboxymaltose, used for the treatment of confirmed iron deficiency. Each 10ml single-use vial contains 500mg of iron as ferric carboxymaltose, equivalent to a concentration of 50mg iron per ml.
Ferinject may be prescribed where oral iron preparations are ineffective, cannot be used, or where there is a clinical need to deliver iron rapidly. Manufactured by Vifor Pharma and supplied by AestheticsRx Pharma — a GPhC-registered distance selling pharmacy — to verified UK healthcare professionals and prescribers only.
Licensed Indications
Ferinject is indicated for the treatment of iron deficiency where:
- Oral iron preparations are ineffective
- Oral iron preparations cannot be used
- There is a clinical need to deliver iron rapidly
The diagnosis of iron deficiency must be based on appropriate laboratory testing. Relevant assessment may include haemoglobin, serum ferritin, transferrin saturation, and other clinically appropriate iron-status investigations.
Ferinject should not be administered solely for non-specific symptoms such as tiredness or fatigue without appropriate clinical investigation confirming iron deficiency.
How Ferinject Works
Ferinject contains ferric carboxymaltose, an intravenous iron complex. Following administration, the iron becomes available for use by the body in processes including haemoglobin production and the replenishment of iron stores. Iron is essential for normal red blood cell and haemoglobin production and oxygen transport.
Key Benefits
- Prescription-only intravenous iron preparation containing ferric carboxymaltose
- 500mg iron per 10ml single-use vial — 50mg iron per ml concentration
- Used for the treatment of confirmed iron deficiency
- Suitable where oral iron is ineffective or cannot be used
- May be used where rapid iron replacement is clinically required
- Can be administered by intravenous injection or intravenous infusion
- Supplied as a single 10ml vial
- Professional healthcare use only — not suitable for self-administration
Product Details
- • Product name: Ferinject 50mg iron/ml
- • Active ingredient: Ferric carboxymaltose
- • Concentration: 50mg iron per ml
- • Vial size: 10ml
- • Iron content per vial: 500mg
- • Pack size: 1 × 10ml single vial
- • Pharmaceutical form: Dispersion for injection / infusion
- • Appearance: Dark brown, non-transparent aqueous dispersion
- • Route: Intravenous use only
- • Legal category: Prescription-only medicine (POM)
- • Manufacturer / UK company: Vifor Pharma
- • Single-use vial: Yes
Always check the physical packaging, prescription, patient information leaflet, batch number, expiry date, and current SmPC before supply or administration.
Route of Administration
Ferinject must only be administered intravenously. It may be administered by:
- Intravenous injection
- Intravenous infusion
- Direct administration into the venous limb of a haemodialysis circuit where clinically appropriate
Ferinject must not be administered intramuscularly or subcutaneously.
Hypersensitivity & Anaphylaxis Warning
Parenteral iron preparations can cause hypersensitivity reactions, including serious and potentially fatal anaphylactic reactions. Reactions can occur even after previously uneventful doses.
Ferinject should therefore only be administered where:
- Staff trained to evaluate and manage anaphylaxis are immediately available
- Full resuscitation facilities can be assured
- Emergency treatment is immediately accessible
- The patient can be monitored appropriately
The patient must be observed for at least 30 minutes after every Ferinject administration.
Hypophosphataemia Warning
Ferinject can cause hypophosphataemia. Repeated administration or prolonged treatment may, in some patients, result in persistent low phosphate levels and may contribute to osteomalacia and fractures.
Serum phosphate monitoring should be considered in patients:
- Receiving repeated high doses
- Receiving long-term treatment
- With existing risk factors for hypophosphataemia
- Experiencing worsening fatigue, muscle pain, or bone pain
Purchase & Resuscitation Facilities Declaration
By purchasing this product, you confirm and accept that full resuscitation facilities are available on site where Ferinject will be administered. By purchasing Ferinject, you also confirm that:
- The product 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
- The treatment environment is suitable for administration of intravenous medicines
- Appropriate clinical assessment and laboratory confirmation of iron deficiency will take place before treatment
Do not purchase or administer Ferinject if full resuscitation facilities and appropriately trained personnel are not available on site.
Professional Use Only
Ferinject must only be prescribed and administered by appropriately qualified healthcare professionals. Appropriate assessment, iron-status testing, dose calculation, IV administration competency, monitoring, and emergency procedures must be in place before treatment.
Ferinject is not suitable for self-administration under any circumstances.
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