RAUTEVENE Solution for injection Ref.[51237] Active ingredients: Iron sucrose

RAUTEVENE contains sucrose.

Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorption or sucrase-isomaltase insufficiency should not take RAUTEVENE.

The sucrose contained in RAUTEVENE may have an effect on the glycaemic control of patients with diabetes mellitus.

RAUTEVENE has a pH of 11 and must therefore be given strictly by the intravenous route.

The maximum daily dose of 200 mg should not be exceeded.

RAUTEVENE should only be used for the approved indications.

RAUTEVENE should only be administered if iron deficiency has been diagnostically established and confirmed by suitable laboratory tests (e.g. blood ferritin levels, haemoglobin, haemocrit or red blood cell count) and, calculated from the latter mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and mean corpuscular haemoglobin concentration (MCHC).

RAUTEVENE may cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful exposure to parenteral iron complexes.

The risk is enhanced for patients with known allergies including medicine allergies and patients with a history of severe asthma, eczema or other atopic allergy.

There is an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).

RAUTEVENE should only be administered in an environment where full resuscitation can be assured and when staff trained to evaluate and manage anaphylactic reactions is immediately available. Each patient should be observed for adverse effects for at least 30 minutes following each RAUTEVENE 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 1:1 000 epinephrine (adrenaline) solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.

Hypotensive episodes may occur if the injection is administered too rapidly.

Patients with low binding capacity and/or folic acid deficiency are at increased risk of allergic or anaphylactic reactions.

Paravenous leakage must be avoided. In cases of inadvertent paravenous leakage, and while the needle is still inserted, rinse with a small amount of 0,9% m/v sodium chloride solution.

Porphyria: Safety has not been established.

RAUTEVENE should not be administered concomitantly with oral iron preparations, since the absorption of oral preparations is reduced.

RAUTEVENE should not be used in the first trimester of pregnancy (see Contraindications).

In the second and third trimester RAUTEVENE should only be used after careful benefit-risk assessment and only in cases of severe iron deficiency anaemia where there is an inability to absorb or tolerate adequate amounts of oral iron.

Safety during lactation has not been established.

Mothers on RAUTEVENE should not breastfeed their infants.

After being given RAUTEVENE, the patient may feel dizzy, confused or lightheaded.

If this happens, the patient should be advised not to drive or use any machinery.

Side effects:

Cardiac disorders

Less frequent: Tachycardia and palpitations.

Vascular disorders

Less frequent: Hypotension and collapse.

Gastro-intestinal disorders

Less frequent: Nausea, vomiting, abdominal pain, diarrhoea.

General disorders and administrative site conditions

Less frequent: Fever, shivering, flushing, chest pain and tightness. Injection site disorders such as superficial phlebitis, burning, swelling. Fatigue, asthenia, malaise. Hyperhidrosis.

Immune system disorders

Less frequent: Anaphylactic and anaphylactoid reactions (involving arthralgia), peripheral oedema, angioedema.

Nervous system disorders

Frequent: Transient taste perversions (in particular metallic taste).

Less frequent: Reduced level of consciousness, lightheaded feeling, confusion, headache, dizziness, paraesthesia.

Musculoskeletal, connective tissue and bone disorders

Less frequent: Muscle cramps, myalgia, swelling of joints, back pain.

Respiratory, thoracic and mediastinal disorders

Less frequent: Bronchospasm, dyspnoea.

Skin and subcutaneous tissue disorders

Less frequent: Pruritus, urticaria, rash, exanthema, erythema.