| Changes to the following;
Section 2: Added the following ;
After reconstitution, the solution contains 40 units of imiglucerase per ml, and after dilution the concentration varies from 1 unit to 2 units/ml.
Section 4.2: Deleted paragraph 2
Added the following to paragraph 7& 8;
The efficacy of Cerezyme on neurological symptoms of chronic neuronopathic Gaucher patients has not been established and no special dosage regimen can be recommended for these manifestations (see section 5.1).
After reconstitution and dilution (see section 6.6) the preparation is administered by intravenous infusion over 1 to 2 hours. Alternatively, the appropriate dose of Cerezyme may be administered at a rate not exceeding 1 unit per kg body weight per minute.
Section 4.4: Added the following;
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6). To be taken into consideration by patients on a controlled sodium diet.
Section 4.6: Altered the section to read the following;
There are no adequate data from the use of imiglucerase in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonal/foetal development and parturition and postnatal development (see section 5.3). The potential risk for humans is unknown. Cerezyme should not be used during pregnancy unless clearly necessary (when the indication and need are clear and the potential benefit is judged by the physician to substantially justify the risk).
Section 4.8: the following paragraph was added;
Adverse drug reactions reported to be related to Cerezyme administration have been reported in less than 14% of patients. Adverse drug reactions are listed by system organ class and frequency (common (³1/100 to <1/10) and uncommon (³1/1,000 to <1/100)) in the table below. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Section 9 & 10 also ammended to include date of last renwal & date of revision of text.
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