Product Description:

• 5 Ampoules of Monofer 100 MG/ML SOL. FOR INJ./INF,Dark brown, non-transparent solution,indicated for the treatment of iron deficiency in the following conditions:


• When oral iron preparations are ineffective or cannot be used.


• Where there is a clinical need to deliver iron rapidly.

How to use:

• Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Monofer.


• Monofer 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.


• The patient should be observed for adverse effects for at least 30 minutes following each Monofer injection (see section 4.4).


• Each IV iron administration is associated with a risk of a hypersensitivity reaction. Thus, to minimize risk the number of single IV iron administrations should be kept to a minimum.

Caution & Warnings:

• 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.


• The risk 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).


• Monofer 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 Monofer injection. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardiorespiratory 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.

Ingredients:

• Ferric Derisomaltose 100 MG/ML