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Venofer 100mg / 5ml × 5 Vials — Iron Sucrose
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Venofer 100mg / 5ml is a prescription-only intravenous iron medicine containing iron sucrose, with 100mg iron per 5ml vial (20mg/ml). Indicated for the treatment of iron deficiency where rapid iron replacement is required, where oral iron is not tolerated or unsuitable, or in inflammatory bowel disease and chronic kidney disease where oral iron is ineffective. Supplied as 5 × 5ml vials for professional healthcare use only.
Instructions:
Venofer 100mg / 5ml x 5 Vials – Full Product Instructions
Professional Use Instructions
Venofer 100mg / 5ml must only be administered by an appropriately trained healthcare professional.
It is a prescription-only intravenous iron medicine and must be used exactly as prescribed. The cumulative dose must be calculated individually for each patient and must not be exceeded.
Do not self-administer.
Before Use
Before administering Venofer, the healthcare professional should:
* Confirm the patient’s identity
* Confirm the prescription and clinical indication
* Confirm laboratory evidence of iron deficiency
* Check haemoglobin, ferritin, transferrin saturation or other relevant blood results
* Review allergy history
* Review previous reactions to parenteral iron products
* Review pregnancy or breastfeeding status where relevant
* Review infection status
* Review liver function and iron overload risk where relevant
* Check current medication, including oral iron
* Confirm resuscitation facilities are available
* Ensure staff trained to manage anaphylaxis are immediately available
* Check the vial, batch number and expiry date
* Inspect the vial for damage, sediment or abnormal appearance
Do not use if the vial is damaged, expired, contaminated or if the solution contains sediment or does not appear homogeneous.
Usual Adult Dose
The usual adult dose is 5–10ml Venofer, equivalent to 100–200mg iron, given 1 to 3 times per week.
The exact dose, frequency and total cumulative dose must be calculated and prescribed according to the patient’s iron deficit, haemoglobin level, body weight and clinical need.
If the total required dose exceeds the maximum permitted single dose, administration must be divided.
Route of Administration
Venofer must only be administered intravenously.
It may be given by:
* Slow intravenous injection
* Intravenous drip infusion
* Directly into the venous line of a dialysis machine during haemodialysis, where appropriate
Do not administer intramuscularly.
Do not administer subcutaneously.
Intravenous Infusion
For intravenous drip infusion, Venofer must only be diluted in sterile 0.9% sodium chloride solution.
Dilution must take place immediately before infusion.
Typical dilution and minimum infusion times include:
* 50mg iron / 2.5ml Venofer diluted up to 50ml sodium chloride 0.9%: minimum 8 minutes
* 100mg iron / 5ml Venofer diluted up to 100ml sodium chloride 0.9%: minimum 15 minutes
* 200mg iron / 10ml Venofer diluted up to 200ml sodium chloride 0.9%: minimum 30 minutes
For stability reasons, dilutions to lower Venofer concentrations are not permitted.
Slow Intravenous Injection
Venofer may be administered by slow intravenous injection at a rate of 1ml undiluted solution per minute.
Do not exceed 10ml Venofer, equivalent to 200mg iron, per injection.
Monitoring During and After Administration
Patients must be carefully monitored for signs and symptoms of hypersensitivity during and after every administration.
Observe the patient for adverse effects for at least 30 minutes after each Venofer administration.
Stop treatment immediately if signs of hypersensitivity, intolerance or allergic reaction occur.
Facilities and equipment for cardiopulmonary resuscitation and management of acute anaphylactic or anaphylactoid reactions must be available.
Do Not Use Venofer If
Do not use Venofer if the patient:
* Is allergic to iron sucrose
* Is allergic to Venofer or any ingredient in the product
* Has known serious hypersensitivity to other parenteral iron products
* Has anaemia not caused by iron deficiency
* Has evidence of iron overload
* Has hereditary disturbances in iron utilisation
* Has been advised not to receive intravenous iron by a healthcare professional
Important Warnings and Precautions
Extra caution is required if the patient:
* Has a history of medicine allergies
* Has severe asthma
* Has eczema or other atopic allergy
* Has immune or inflammatory conditions such as systemic lupus erythematosus or rheumatoid arthritis
* Has liver dysfunction
* Has risk factors for iron overload
* Has acute or chronic infection
* Has bacteraemia
* Is pregnant or breastfeeding
* Has previously reacted to injectable or intravenous iron
* Is medically unstable or requires close monitoring
Parenteral iron should be used with caution in acute or chronic infection. Administration should be stopped in patients with bacteraemia.
Extravasation Warning
Paravenous leakage must be avoided.
Leakage of Venofer at the injection site can cause pain, inflammation and brown discolouration of the skin.
If extravasation occurs, stop administration and manage according to local clinical protocol.
Oral Iron Interaction
Venofer should not be administered at the same time as oral iron preparations because oral iron absorption may be reduced.
Oral iron therapy should be started at least 5 days after the last Venofer administration, unless otherwise directed by a healthcare professional.
Pregnancy and Breastfeeding
Venofer should only be used during pregnancy where clearly necessary and after careful risk-benefit assessment.
Iron deficiency anaemia in the first trimester can often be treated with oral iron. Venofer use in pregnancy should generally be confined to the second and third trimester where the benefit is judged to outweigh the potential risk.
The unborn baby should be carefully monitored during intravenous administration of parenteral iron to pregnant women.
For breastfeeding patients, a healthcare professional should assess the benefit and risk before treatment.
Possible Side Effects
Like all medicines, Venofer can cause side effects, although not everyone will experience them.
Possible side effects may include:
* Taste disturbance
* Nausea
* Injection or infusion-site reaction
* Injection-site pain
* Injection-site irritation
* Injection-site discolouration
* Injection-site haematoma
* Low blood pressure
* High blood pressure
* Headache
* Dizziness
* Flushing
* Vomiting
* Abdominal pain
* Diarrhoea
* Constipation
* Rash
* Itching
* Muscle pain
* Joint pain
* Back pain
* Chills
* Tiredness
* Swelling
* Chest pain
* Fever
* Feeling faint or light-headed
Serious reactions may include:
* Hypersensitivity reaction
* Anaphylactic or anaphylactoid reaction
* Angioedema
* Breathing difficulty
* Bronchospasm
* Collapse
* Severe low blood pressure
* Fast or slow heartbeat
* Kounis syndrome
* Loss of consciousness
* Severe skin reaction
Seek urgent medical attention if the patient develops breathing difficulty, swelling of the face or throat, collapse, severe dizziness, chest pain, severe rash or any signs of a serious allergic reaction.
Driving and Machinery
If the patient experiences dizziness, confusion or light-headedness after Venofer administration, they should not drive, cycle, use tools or operate machinery until symptoms have fully resolved.
Storage Instructions
Do not store above 25°C.
Do not freeze.
Store in the original package.
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the packaging.
Once opened, the product should be used immediately.
After dilution with sterile 0.9% sodium chloride, the diluted solution should be used immediately from a microbiological point of view.
Handling Instructions
Inspect each vial before use.
Use only vials containing a sediment-free, homogeneous solution.
Venofer must not be mixed with other medicinal products except sterile 0.9% sodium chloride solution for dilution.
The diluted solution must appear brown and clear.
Each vial is for single use only.
Disposal
Dispose of used vials, needles, syringes, infusion equipment and clinical waste according to local clinical waste and sharps disposal procedures.
Do not reuse opened vials.
Do not keep unused solution from an opened vial for later use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Disclaimer
This information is provided for general product guidance and does not replace the prescription, dispensing label, patient information leaflet, SmPC, pharmacist counselling, clinical assessment or advice from a healthcare professional. Always use Venofer exactly as prescribed and in accordance with current manufacturer guidance.
Description
Venofer 100mg / 5ml x 5 Vials – Full Product Description
Venofer 100mg / 5ml is a prescription-only intravenous iron medicine containing iron sucrose. Each 5ml vial contains 100mg iron as iron sucrose, equivalent to 20mg iron per ml.
Venofer is used for the treatment of iron deficiency where clinically appropriate and prescribed by a healthcare professional. It may be used where there is a clinical need for rapid iron supply, where oral iron is not tolerated or unsuitable, in active inflammatory bowel disease where oral iron preparations are ineffective, or in chronic kidney disease where oral iron preparations are less effective.
This pack contains 5 × 5ml vials and is intended for professional healthcare use only.
Key Benefits
- Prescription-only intravenous iron medicine
- Contains iron sucrose
- 100mg iron per 5ml vial
- 20mg iron per ml
- Supplied as 5 × 5ml vials
- Used for treatment of clinically confirmed iron deficiency
- Suitable where rapid iron replacement is clinically required
- May be used where oral iron is not tolerated or unsuitable
- May be used in selected inflammatory bowel disease or chronic kidney disease patients where oral iron is ineffective or less effective
- Can be administered by slow intravenous injection or intravenous infusion
- Professional healthcare use only
- Not suitable for self-administration
Product Details
- Product name: Venofer 20mg iron/ml
- Common listing name: Venofer 100mg / 5ml
- Active ingredient: Iron sucrose
- Strength: 100mg iron per 5ml vial
- Concentration: 20mg iron per ml
- Pack size: 5 × 5ml vials
- Pharmaceutical form: Solution for injection or concentrate for solution for infusion
- Appearance: Dark brown, non-transparent aqueous solution
- Route: Intravenous use only
- Legal category: Prescription Only Medicine
- Manufacturer / MA holder: Vifor
- Use: Treatment of iron deficiency where prescribed
Always check the physical packaging, prescription, dispensing label, patient information leaflet, batch number, expiry date and current SmPC before supply or use.
What Venofer Is Used For
Venofer is indicated for the treatment of iron deficiency in situations such as:
- Where there is a clinical need for rapid iron supply
- Where patients cannot tolerate oral iron therapy
- Where patients are non-compliant with oral iron therapy
- Active inflammatory bowel disease where oral iron preparations are ineffective
- Chronic kidney disease where oral iron preparations are less effective
The diagnosis of iron deficiency must be based on appropriate laboratory tests such as haemoglobin, serum ferritin, transferrin saturation and serum iron.
How Venofer Works
Venofer contains iron sucrose, an intravenous iron complex. After administration, the iron is made available for the body’s iron transport and storage systems, including transferrin and ferritin.
Iron is required for the production of haemoglobin, the protein in red blood cells that carries oxygen around the body. Venofer helps replace iron in patients with confirmed iron deficiency where intravenous treatment is appropriate.
Important Use Note
Venofer must only be administered by the intravenous route.
It must not be given by intramuscular or subcutaneous injection.
Venofer should only be administered where staff trained to recognise and manage anaphylactic reactions are immediately available and where resuscitation facilities can be assured.
Patients must be monitored during and after each administration.
Prescription Use Only
Venofer must only be supplied against a valid prescription or under an appropriate clinical service.
It should only be administered by trained healthcare professionals following clinical assessment, laboratory confirmation of iron deficiency, prescription requirements, manufacturer guidance and local clinical protocols.
Purchase & Safety Declaration
By purchasing Venofer, the purchaser confirms and accepts that this product will only be administered by an appropriately trained healthcare professional in a suitable clinical setting.
The purchaser also confirms that appropriate resuscitation facilities are available on site and that staff trained to recognise and manage serious hypersensitivity, anaphylactic and anaphylactoid reactions are immediately available during administration.
Venofer must not be administered in any setting where appropriate monitoring, emergency medicines, resuscitation equipment and trained personnel are not available.
Patients must be monitored during administration and observed for at least 30 minutes after each dose.
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