In Section 4.8 the following deletions and insertions have been made:
4.8 Undesirable Effects
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention:Frequency estimate: very common (³ 1/10);, common (³ 1/100 to < 1/10); uncommon (³ 1/1,000 to ≤ 1/100); rare (³ 1/10,000 to ≤ 1/1,000); very rare (≤ 1/10,000) including isolated reports; not known (cannot be estimated from the available data).
Some signs and symptoms reported as adverse effects may also be manifestations of the underlying disease (iron and/or aluminium overload).
Special remarks
At the injection site pain, swelling, infiltration, erythema, pruritus and eschar/crust are very common; vesicles, local oedema and burning are uncommon reactions. The local manifestations may be accompanied by systemic reactions like arthralgia/myalgia (very common), headache (common), urticaria (common), nausea (common), pyrexia (common), vomiting (uncommon), or abdominal pain (uncommon) or asthma (uncommon).
Table 1
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Immune system disorders
Very rare: anaphylactic shock, anaphylactic reactions, angioneurotic oedema.
Eye disorders
Rare: loss of vision, scotoma, retinal degeneration, optic neuritis, cataracts (visual acuity decreased), blurred vision, night blindness, visual field defects, chromatopsia (impairment of colour vision), corneal opacities, (see 4.4. Special warnings and special
Ear and labyrinth disorders
UncommonRare special
Skin and subcutaneous tissue disorders
Very rare: rash generalised.
Musculoskeletal and connective tissue disorders
Common: growth retardation and bone disorder (e.g. metaphyseal dysplasia) are common in chelated patients given doses of 60 mg/kg, especially those who begin iron chelation in the first three years of life. If doses are kept to 40 mg/kg or below, the risk is considerably reduced (see 4.4 Special warnings and special
Unknown: muscle spasms.
Respiratory, thoracic and mediastinal disorders
Very rare: acute respiratory distress lung infiltration (see 4.4 Special warnings and special
Nervous system disorders
Very rare: neurological disturbances, dizziness, precipitation or exacerbation of aluminium-related dialysis encephalopathy, neuropathy peripheral, paraesthesia (see 4.4 Special warnings and precautions for use).
Unknown: convulsion.
Gastrointestinal disorders
Very rare: diarrhoea.
Renal and urinary disorders
UnknownVery rarerenal impairment
Vascular disorders
Rare: hypotension if precautions for administration are not followed (see 4.2 Posology and method of administration and 4.4 Special warnings and precautions for use).
Blood and lymphatic system disorders
Very rare: blood disorders including (e.g. , leukopenia).
Unknown: leukopenia
Infections and infestations
Rare:
Very rare: Gastroenteritis yersinia infections have been (see 4.4 Special warnings and precautions for use).
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Special remarks
At the injection site pain, swelling, infiltration, erythema, pruritus and eschar/crust are very common; vesicles, local oedema and burning are uncommon reactions. The local manifestations may be accompanied by systemic reactions like arthralgia/myalgia (very common), headache (common), urticaria (common), nausea (common), pyrexia (common), vomiting (uncommon), or abdominal pain (uncommon) or asthma (uncommon).
Convulsion has been mainly reported in dialysed patients with aluminium overload.
Rare cases of increased transaminases have been reported in patients who have been treated with Desferal, however a causality with the drug is not established.
In Section 4.9 the text underlined has been added to the second paragrah:
Signs and symptoms: tachycardia, hypotension and gastro-intestinal symptoms have occasionally occurred in patients who received an overdose of Desferal. Accidental administration of Desferal by the i.v. route may be associated with acute but transient loss of vision, aphasia, agitation, headache, nausea, bradycardia, hypotension and acute renal failure (see section 4.8 Undesirable effects).
In Section 4.4 the text underlined has been added to the first paragraph:
Desferal should be used with caution in patients with renal impairment since the metal complexes are excreted via the kidneys. In these patients, dialysis will increase the elimination of chelated iron and aluminium. Isolated cases of acute renal failure have been reported (see also section 4.8 Undesirable effects).
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