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.