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Prescribing Information

Ferinject  (ferric carboxymaltose)

Prescribing Information - UK

 

For full prescribing information refer to the Summary of Product Characteristics (SmPC)

 

Active ingredient: Ferric carboxymaltose (50mg/mL)

Presentation: Solution for injection/infusion. Available as a 2mL vial (as 100mg of iron), 10mL vial (as 500mg of iron) and 20mL vial (as 1000mg of iron).

Indication: Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests.

Dosage and Administration: The posology of Ferinject follows a stepwise approach: Step 1: Determination of the iron need; The individual iron need for repletion using Ferinject is determined based on the patient's body weight and haemoglobin (Hb) level. The table in the SmPC should be used to determine the iron need. Step 2: Calculation and administration of the maximum individual iron dose(s); Based on the iron need determined, the appropriate dose(s) of Ferinject should be administered: A single Ferinject administration should not exceed: • 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion) The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL Ferinject) per week. Administration rates for intravenous injection: For iron doses of 100mg to 200mg, there is no prescribed administration time. For doses >200mg to 500mg, Ferinject should be administered at a rate of 100mg iron/min. For doses >500mg to 1,000mg, the minimum administration time is 15 min. Administration of intravenous drip infusion: For iron doses of 100mg to 200mg, there is no prescribed administration time. For doses >200mg to 500mg, Ferinject should be administered in a minimum of 6 mins. For doses >500mg to 1,000mg, the minimum administration time is 15 mins. Ferinject must be diluted in 0.9% m/V NaCl but not diluted to concentrations less than 2 mg iron/mL. Step 3: Post-iron repletion assessments

Contraindications: Hypersensitivity to Ferinject or any of its excipients. Known serious hypersensitivity to other parenteral iron products. Anaemia not attributed to iron deficiency. Iron overload or disturbances in utilisation of iron.

Special warnings and precautions: Parenterally administered iron preparations can cause potentially fatal anaphylactic/anaphylactoid reactions. The risk is enhanced for patients with known allergies, a history of severe asthma, eczema or other atopic allergy, and in patients with immune or inflammatory conditions. Ferinject should only be

administered in the presence of staff trained to manage anaphylactic reactions where full resuscitation facilities are available (including 1:1000 adrenaline solution). Each patient should be observed for 30 minutes following administration. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Parenterally administered iron preparations can cause hypophosphataemia which in most cases is transient and without clinical symptoms. Cases of hypophosphataemia requiring medical attention were reported, mainly in patients with existing risk factors and after prolonged exposure to high-dose intravenous iron. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Careful monitoring of iron status is recommended to avoid iron overload. There is no safety data on the use of single doses of more than 200mg iron in haemodialysis-dependent chronic kidney disease patients. Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies. It is recommended that treatment with Ferinject is stopped in patients with ongoing bacteraemia. In patients with chronic infection a benefit/risk evaluation has to be performed. Caution should be exercised to avoid paravenous leakage when administering Ferinject.

Special populations A single maximum daily dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients. The use of Ferinject has not been studied in children. A careful risk/benefit evaluation is required before use during pregnancy. Ferinject should not be used during pregnancy unless clearly necessary and should be confined to the second and third trimester. Foetal bradycardia may occur during administration of parenteral irons, as a consequence of hypersensitivity. The unborn baby should be carefully monitored during administration to pregnant women.

Undesirable effects Common (≥1/100 to <1/10): Hypophosphataemia, headache, dizziness, flushing, hypertension, nausea, injection/infusion site reactions. Rare (≥1/10,000 to <1/1,000): Anaphylactoid/anaphylactic reactions. Please consult the SmPC in relation to other undesirable effects.

Legal category: POM

Price: pack of 5 x 2ml = £95.50; pack of 5 x 10ml = £477.50; pack of 1 x 20ml = £154.23

MA Number: 15240/0002

Date of Authorisation: 19.07.2007

MA Holder: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

 

Ferinject® is a registered trademark

 

Document number: UK-FCM-1900344
Date of preparation: 11/19


Adverse events should be reported

 

Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard

Adverse events should also be reported to Vifor Pharma UK Ltd.
Tel: +44 1276 853633

 

Ferinject  (ferric carboxymaltose)

Prescribing Information - Ireland

 

For full prescribing information refer to the Summary of Product Characteristics (SmPC)

 

Active ingredient: Ferric carboxymaltose (50mg/mL)

Presentation: Solution for injection/infusion. Available as a 10mL vial (as 500mg of iron) and 20mL vial (as 1000mg of iron).

Indication: Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests.

Dosage and Administration: The posology of Ferinject follows a stepwise approach: Step 1: Determination of the iron need; The individual iron need for repletion using Ferinject is determined based on the patient's body weight and haemoglobin (Hb) level. The table in the SmPC should be used to determine the iron need. Step 2: Calculation and administration of the maximum individual iron dose(s); Based on the iron need determined, the appropriate dose(s) of Ferinject should be administered: A single Ferinject administration should not exceed: • 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion) The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL Ferinject) per week. Administration rates for intravenous injection: For iron doses of 100mg to 200mg, there is no prescribed administration time. For doses >200mg to 500mg, Ferinject should be administered at a rate of 100mg iron/min. For doses >500mg to 1,000mg, the minimum administration time is 15 min. Administration of intravenous drip infusion: For iron doses of 100mg to 200mg, there is no prescribed administration time. For doses >200mg to 500mg, Ferinject should be administered in a minimum of 6 mins. For doses >500mg to 1,000mg, the minimum administration time is 15 mins. Ferinject must be diluted in 0.9% m/V NaCl but not diluted to concentrations less than 2 mg iron/mL. Step 3: Post-iron repletion assessments

Contraindications: Hypersensitivity to Ferinject or any of its excipients. Known serious hypersensitivity to other parenteral iron products. Anaemia not attributed to iron deficiency. Iron overload or disturbances in utilisation of iron.

Special warnings and precautions: Parenterally administered iron preparations can cause potentially fatal anaphylactic/anaphylactoid reactions. The risk is enhanced for patients with known allergies, a history of severe asthma, eczema or other atopic allergy, and in patients with immune

or inflammatory conditions. Ferinject should only be administered in the presence of staff trained to manage anaphylactic reactions where full resuscitation facilities are available (including 1:1000 adrenaline solution). Each patient should be observed for 30 minutes following administration. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Parenterally administered iron preparations can cause hypophosphataemia which in most cases is transient and without clinical symptoms. Cases of hypophosphataemia requiring medical attention were reported, mainly in patients with existing risk factors and after prolonged exposure to high-dose intravenous iron. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Careful monitoring of iron status is recommended to avoid iron overload. There is no safety data on the use of single doses of more than 200mg iron in haemodialysis-dependent chronic kidney disease patients. Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies. It is recommended that treatment with Ferinject is stopped in patients with ongoing bacteraemia. In patients with chronic infection a benefit/risk evaluation has to be performed. Caution should be exercised to avoid paravenous leakage when administering Ferinject.

Special populations: A single maximum daily dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients. The use of Ferinject has not been studied in children. A careful risk/benefit evaluation is required before use during pregnancy. Ferinject should not be used during pregnancy unless clearly necessary and should be confined to the second and third trimester. Foetal bradycardia may occur during administration of parenteral irons, as a consequence of hypersensitivity. The unborn baby should be carefully monitored during administration to pregnant women.

Undesirable effects: Common (≥1/100 to <1/10): Hypophosphataemia, headache, dizziness, flushing, hypertension, nausea, injection/infusion site reactions. Rare (≥1/10,000 to <1/1,000): Anaphylactoid/anaphylactic reactions. Please consult the SmPC in relation to other undesirable effects.

Legal category: POM

MA Number: 15240/0002

Date of Authorisation: 19.07.2007

MA Holder: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

 

Ferinject® is a registered trademark

Date of revision: 11/2019

 

Job bag number: IE-FCM-1900100


Adverse events should be reported.

 

Reporting forms and information can be found at:

https://www.hpra.ie/ 

Adverse events should also be reported to Vifor Pharma UK Ltd.
Tel: +44 1276 853633

 

Venofer®  (iron sucrose)

Prescribing Information - UK

 

For full prescribing information refer to the Summary of Product Characteristics (SmPC)

 

Active ingredient: Iron sucrose (20mg/mL)

Presentation: Solution for injection/infusion. Available as a 5mL vial (as 100mg of iron).

Indication: Treatment of iron deficiency where there is a clinical need for a rapid iron supply, in patients who cannot tolerate oral iron therapy or who are non-compliant, in active inflammatory bowel disease where oral iron preparations are ineffective, and in chronic kidney disease when oral iron preparations are less effective. The diagnosis of iron deficiency must be based on appropriate laboratory tests.

Dosage and Administration: The total cumulative dose of Venofer, equivalent to the total iron deficit (mg), must be individually determined for each patient, based on haemoglobin level and body weight and calculated with the Ganzoni formula. The total single dose must not exceed 200 mg of iron given not more than three times per week. Administration for intravenous drip infusion: Venofer must be diluted only in sterile 0.9% m/V sodium chloride solution up to a maximum dilution of 1 mg/ml. For iron doses of 50mg, minimum infusion time is 8 minutes. For doses of 100mg, minimum infusion time is 15 minutes. For doses of 200mg, the minimum administration time is 30 min. Intravenous injection: Venofer may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml Venofer (200 mg iron) per injection.

Administration into dialysis machine: Venofer may be administered during a haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.

Contraindications: Hypersensitivity to Venofer or any of its excipients. Known serious hypersensitivity to other parenteral iron products. Anaemia not attributed to iron deficiency. Iron overload or disturbances in utilisation of iron.

Special warnings and precautions: Parenterally administered iron preparations can cause potentially fatal anaphylactic/anaphylactoid reactions. The risk is enhanced for patients with known allergies, a history of severe asthma, eczema or other atopic allergy, and in patients with immune or inflammatory conditions. There have been reports of hypersensitivity reactions which progressed to Kounis

syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). Venofer should only be administered in the presence of staff trained to manage anaphylactic reactions where full resuscitation facilities are available (including 1:1000 adrenaline solution). Each patient should be observed for 30 minutes following administration. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Careful monitoring of iron status is recommended to avoid iron overload. Parenteral iron must be used with caution in patients with acute or chronic infection, asthma, eczema or atopic allergies. It is recommended that treatment with Venofer is stopped in patients with ongoing bacteraemia. In patients with chronic infection a benefit/risk evaluation has to be performed. Caution should be exercised to avoid paravenous leakage when administering Venofer.

Special populations: The use of Venofer has not been studied in children. A careful risk/benefit evaluation is required before use during pregnancy. Venofer should not be used during pregnancy unless clearly necessary and should be confined to the second and third trimester. Foetal bradycardia may occur during administration of parenteral irons, as a consequence of hypersensitivity. The unborn baby should be carefully monitored during administration to pregnant women.

Undesirable effects: Common (≥1/100 to <1/10): Dysgeusia, hypotension, hypertension, nausea and injection/infusion site reactions. Frequency not known: Anaphylactoid/anaphylactic reactions and Kounis syndrome. Please consult the SmPC in relation to other undesirable effects.

Legal category: POM

Price: pack of 5 x 5ml = £43.52

MA Number: PL 15240/0001

Date of Authorisation: 08.06.1998

MA Holder: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

 

Venofer® is a registered trademark

 

Document number: UK-VEN-2000001
Date of preparation: 01/2020


Adverse events should be reported.

 

Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard

Adverse events should also be reported to Vifor Pharma UK Ltd.
Tel: +44 1276 853633
Email: medicalinfo_UK@viforpharma.com

 

Venofer® (iron sucrose)

Prescribing Information - Ireland

 

For full prescribing information refer to the Summary of Product Characteristics (SmPC)

 

Active ingredient: Iron sucrose (20mg/mL)

Presentation: Solution for injection/infusion. Available as a 5mL vial (as 100mg of iron

Indication: Treatment of iron deficiency where there is a clinical need for a rapid iron supply, in patients who cannot tolerate oral iron therapy or who are non-compliant, in active inflammatory bowel disease where oral iron preparations are ineffective, and in chronic kidney disease when oral iron preparations are less effective. The diagnosis of iron deficiency must be based on appropriate laboratory tests.

Dosage and Administration: The total cumulative dose of Venofer, equivalent to the total iron deficit (mg), must be individually determined for each patient, based on haemoglobin level and body weight and calculated with the Ganzoni formula. The total single dose must not exceed 200 mg of iron given not more than three times per week. Administration for intravenous drip infusion: Venofer must be diluted only in sterile 0.9% m/V sodium chloride solution up to a maximum dilution of 1 mg/ml. For iron doses of 50mg, minimum infusion time is 8 minutes. For doses of 100mg, minimum infusion time is 15 minutes. For doses of 200mg, the minimum administration time is 30 min. Intravenous injection: Venofer may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml Venofer (200 mg iron) per injection.

Administration into dialysis machine: Venofer may be administered during a haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.

Contraindications: Hypersensitivity to Venofer or any of its excipients. Known serious hypersensitivity to other parenteral iron products. Anaemia not attributed to iron deficiency. Iron overload or disturbances in utilisation of iron.

Special warnings and precautions: Parenterally administered iron preparations can cause potentially fatal anaphylactic/anaphylactoid reactions. The risk is enhanced for patients with known allergies, a history of severe asthma, eczema or other atopic allergy, and in patients with immune or inflammatory conditions. There have been reports of

hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). Venofer should only be administered in the presence of staff trained to manage anaphylactic reactions where full resuscitation facilities are available (including 1:1000 adrenaline solution). Each patient should be observed for 30 minutes following administration. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Careful monitoring of iron status is recommended to avoid iron overload. Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies. It is recommended that treatment with Venofer is stopped in patients with ongoing bacteraemia. In patients with chronic infection a benefit/risk evaluation has to be performed. Caution should be exercised to avoid paravenous leakage when administering Venofer.

Special populations: The use of Venofer has not been studied in children. A careful risk/benefit evaluation is required before use during pregnancy. Venofer should not be used during pregnancy unless clearly necessary and should be confined to the second and third trimester. Foetal bradycardia may occur during administration of parenteral irons, as a consequence of hypersensitivity. The unborn baby should be carefully monitored during administration to pregnant women.

Undesirable effects: Common (≥1/100 to <1/10): Dysgeusia, hypotension, hypertension, nausea and injection/infusion site reactions. Frequency not known: Anaphylactoid/anaphylactic reactions and Kounis syndrome. Please consult the SmPC in relation to other undesirable effects.

Legal category: POM

MA Number: PA 949/001/002

Date of Authorisation: 11.09.2009

MA Holder: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

 

Venofer® is a registered trademark

 

Document number: IE-VEN-2000001
Date of preparation: 01/2020


Adverse events should be reported.

 

Reporting forms and information can be found at
http://www.hpra.ie/homepage/about-us/report-an-issue

Adverse events should also be reported to Vifor Pharma UK Ltd.
Tel: +44 1276 853633
Email: medicalinfo_UK@viforpharma.com

 

 
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This website is intended for healthcare professionals who treat iron deficiency and iron deficiency anaemia in adults or patients who have been prescribed this medication.

UK-FCM-1900320, September 2019