nd lactation
Women of child-bearing potential
In women of child-bearing potential, each case the benefits for the mother must be weighed against the risks for the child.
Pregnancy
There is a limited amount of data on the use of desferrioxamine in pregnant patients. Studies in animals (rabbits) have shown reproductive toxicity/teratogenicity (see section 5.3 Preclinical safety data). The risk to the foetus/mother is unknown.
Desferal should be used during pregnancy only if the expected benefits to the mother outweigh the potential risk to the foetus.
Breastfeeding
It is not known whether Desferal is excreted into the breast milk Because many drugs are excreted in human milk, and because of the potential for serious adverse drug reactions in breast-fed newborns/infants, a decision should be made whether to abstain from breast-feeding or to abstain from using the medicinal product, taking into account the importance of the medicinal product to the mother.
4.7 Effects on ability to drive and use machines
Patients experiencing CNS effects such as dizziness or impaired vision or hearing should be warned against driving or operating machinery.
4.8 Undesirable effects
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to ≤ 1/100); rare (≥ 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).
Table 1
Infections and infestations
Rare: Mucormycosis infections have been reported (see 4.4 Special warnings and precautions for use).
Very rare: Gastroenteritis yersinia infections have been reported (see 4.4 Special warnings and precautions for use).
Blood and lymphatic system disorders
Very rare: blood disorders including thrombocytopenia
Unknown: leukopenia
Immune system disorders
Very rare: anaphylactic shock, anaphylactic reactions, angioneurotic oedema.
Nervous system disorders
Very rare: neurological disturbances, including dizziness, precipitation or exacerbation of aluminium-related dialysis encephalopathy, neuropathy peripheral, paraesthesia (see 4.4 Special warnings and precautions for use).
Unknown: convulsion.
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 precautions for use). Eye disorders are rare, except if high doses are given.
Ear and labyrinth disorders
Uncommon: deafness neurosensory, tinnitus (see 4.4. Special warnings and precautions for use). Keeping within dose guidelines helps minimise risk of hearing side effects.
Vascular disorders
Rare: hypotension, tachycardia and shock if precautions for administration are not adhered to (see 4.2 Posology and method of administration and 4.4 Special warnings and precautions for use).
Respiratory, thoracic and mediastinal disorders
Very rare: acute respiratory distress lung infiltration (see 4.4 Special warnings and precautions for use).
Gastrointestinal disorders
Very |
