In section 2
“Each 20 mL vial contains 1000 mg of iron as ferric carboxymaltose.” Has now been added.
volumes are now listed in mL
In section 4.2
“For doses up to 200 mg iron, there is no prescribed administration time.” Has now been added under “Intravenous injection”
The term “intravenous drip infusion” has now been replaced with “intravenous infusion”
Dilution plan of Ferinject for intravenous infusion has been clarified to confirm which dose ranges require what volume of sterile 0.9% m/V sodium chloride solution.
In section 4.8
The following text has been incorporated:
“The most commonly reported ADR is nausea (occurring in 3.1% of the patients), followed by headache, dizziness, and hypertension. Injection site reactions categorised as common in Table 3 are comprised of several ADRs which individually have been reported with a frequency of either uncommon or rare. Hypophosphataemia (common) may occur. In clinical trials the minimum values were obtained after approximately 2 weeks, and 4 to 12 weeks following Ferinject treatment the values had returned to those within the range of baseline. The most serious ADR is anaphylactoid reactions with a frequency of rare.”
Hypertension and hypophosphataemia are now listed as “common”
Dysgeusia, tachycardia, dyspnoea, abdominal pain, constipation, diahorrea, , erythema, rash, muscle spasms and chills are now “uncommon”
Anaphylactoid reactions, loss of consciousness, anxiety, syncope, presyncope, bronchospasm, flatulence, angioedema, pallor, and face oedema, rigors, malaise are now “rare”.
Detail on how to report Adverse events have also been revised.
In section 5.1
Data has been added on clinical efficacy and safety on Ferinject in in different therapeutic areas necessitating intravenous iron to correct iron deficiency.
In section 10
Dates of revision has been updated