Ferinject 50 mg iron/mL solution for injection/infusion as Ferric carboxymaltose
Ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. During pregnancy, inflammatory bowel disease, chronic heart failure.
The use of Ferinject is contraindicated in cases of:
|Hypersensitivity to the active substance, to Ferinject or any of its excipients.|
|Known serious hypersensitivity to other parenteral iron products.|
|Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia.|
|Evidence of iron overload or disturbances in the utilisation of iron.|
In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment.
Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT).
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 the administration of Ferinject® is stopped in patients with ongoing bacteraemia.
In patients with chronic infection a risk/benefit evaluation has to be performed.
Para-venous leakage of ferric carboxymaltose solution at the injection site may lead to irritation of the skin and brown discolouration, which could be potentially long lasting.
In case of para-venous leakage, the administration of ferric carboxymaltose solution must be stopped immediately.
Posology and method of administration:
Maximum tolerated single dose:
|A single dose of Ferinject® should not exceed 1,000 mg of iron (20 mL) per day.|
|Do not administer 1,000 mg of iron (20 mL) more than once a week.|
|Ferinject® may be administered by intravenous injection using undiluted solution up to 1,000 mg iron (up to a maximum of 15 mg/kg body weight). For doses greater than 200 and up to 500 mg iron, Ferinject® should be administered at a rate of 100 mg/min. For doses greater than 500 and up to 1,000 mg iron, Ferinject® should be administered over 15 minutes.|
Intravenous drip infusion:
|Ferinject® may be administered by intravenous infusion up to a maximum single dose of 1,000 mg of iron (up to a maximum of 20 mg/kg body weight).|
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. The compatibility with containers other than polyethylene and glass is not known.