Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Parenterally administered iron preparations may cause hypersensitivity reactions, including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previous, uncomplicated, tolerated injections of parenteral iron preparations. There are reports of hypersensitivity reactions that have developed into Kounis syndrome (acute allergic coronary artery spasms that can lead to myocardial infarction, see section 4.8).


The risk is increased in patients with known allergies, including drug allergies, as well as in those with a history of severe asthma, eczema or other atopic allergy.
In patients with immunological or inflammatory diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, Crohn’s disease), there is also an increased risk of hypersensitivity reactions in the parenteral administration of iron complex preparations.

Ferrlecit should only be used if trained specialists in the detection and treatment of anaphylactic reactions are immediately available and if cardiopulmonary resuscitation is ensured by appropriate equipment. Each patient should be observed for the occurrence of undesirable effects for at least 30 minutes after each Ferrlecit injection. If hypersensitivity reactions or signs of intolerance occur during treatment, treatment must be discontinued immediately. Equipment for cardiopulmonary resuscitation and for the treatment of an acute anaphylactic/anaphylactoid reaction should be available, including an injectable 1:1,000 adrenaline solution. If necessary, additional treatment with antihistamines and/or corticosteroids should be administered.

The degree of iron deficiency must imperatively be assessed prior to IV administration in order to prevent haemosiderosis.

As this medicine contains benzyl alcohol, accidental injection outside of the vein and intramuscular injection are painful and should therefore be avoided. In addition, accidental paravasal use can cause reddish-brown discolouration of the skin.

Benzyl alcohol can cause toxic and anaphylactoid reactions in infants and children under 3 years of age.
The use of medicinal products containing benzyl alcohol has been associated with fatal gasping syndrome in premature infants, newborns and young children (symptoms: sudden onset of gasping, drop in blood pressure, bradycardia and cardiovascular collapse).
Since benzyl alcohol can cross the placental barrier, the solution for injection or the concentrate for solution for infusion should only be used with caution during pregnancy (see section 4.6).

Large amounts of benzyl alcohol should only be used with caution and when absolutely necessary due to the risk of accumulation and toxicity (metabolic acidosis), especially in persons with impaired liver or kidney function and during pregnancy and lactation.

Ferrlecit contains less than 1 mmol sodium (23 mg) per ampoule, that is to say it is essentially “sodium-free”.

Ferrlecit should not be used in patients with the rare hereditary fructose intolerance.

Effects on Driving

4.7   Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.