Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use

Anaphylaxis and severe allergic reactions
Anaphylaxis and severe allergic reactions have been reported in clinical studies. Therefore, appropriate medical support must be readily available when elosulfase alfa is administered. If these reactions occur, immediately stop the infusion and initiate appropriate medical treatment. The current medical standards for emergency treatment are to be followed. For patients who have experienced allergic reactions during infusion, caution should be exercised upon re-administration.


Infusion reactions
Infusion reactions (IRs) were the most commonly observed adverse reactions in clinical studies. IRs may include allergic reactions. Patients should receive antihistamines with or without antipyretics prior to infusion (see section 4.2). Management of IRs should be based on the severity of the reaction and include slowing or temporary interruption of the infusion and/or administration of additional antihistamines, antipyretics, and/or corticosteroids. If severe IRs occur, immediately stop the infusion and initiate appropriate treatment. Re-administration after a severe reaction should be carried out with caution and close monitoring by the treating physician.

Spinal/Cervical cord compression

In clinical studies, spinal/cervical cord compression (SCC) was observed both in patients receiving Vimizim and patients receiving placebo. Patients should be monitored for signs and symptoms of SCC (including back pain, paralysis of limbs below the level of compression, urinary and faecal incontinence) and given appropriate clinical care.

Sodium restricted diet

This medicinal product contains 8 mg sodium per vial, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult, and is administered in sodium chloride 9 mg/ml (0.9%) solution for infusion (see section 6.6).
Sorbitol
This medicinal product contains 100 mg sorbitol in each vial which is equivalent to 40 mg/kg.
Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.

Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI). Medicinal products (containing sorbitol/fructose) given intravenously may be life- threatening. The treatment benefit to the child compared to the associated risks must be fully evaluated prior to treatment.
A detailed history with regard to HFI symptoms has to be taken for each patient prior to being given this medicinal product.

Effects on Driving

4.7    Effects on ability to drive and use machines

Vimizim has minor influence on the ability to drive and use machines. Dizziness was reported during Vimizim infusions; if dizziness occurs after the infusion, the ability to drive and use machines may be affected.