Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions.
Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes including iron sucrose. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8). In several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, iron sucrose was shown to be well tolerated. For known serious hypersensitivity to other parenteral iron product see section 4.3.
The risk of hypersensitivity reactions is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
FERROVIN should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. Each patient should be observed for adverse effects for at least 30 minutes following each FERROVIN injection. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.
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 should be used with caution in the case of acute or chronic infection.
It is recommended that the administration of FERROVIN is stopped in patients with bacteraemia. In patients with chronic infection, a risk/benefit evaluation should be performed.
Paravenous leakage must be avoided because leakage of FERROVIN at the injection site can lead to pain, inflammation and brown discoloration of the skin.

Effects on Driving

4.7 Effects on ability to drive and use machines
In the case of symptoms of dizziness, confusion or light headedness following the administration of FERROVIN, patients should not drive or use machinery until the symptoms have ceased.