| Section 4.1: the medicinal product is recommended for use in adults, hence this section has been updated to refer to ‘adult patients’
Section 4.2: posology section has been reformatted with sub-headings for clarity to the reader, also new information has been inserted in relation to if a dose is missed,
Section 4.3: the word brinzolamide has been replaced with ‘active substance’ and cross-reference with regards ‘hyperchloraemic acidosis’ has been removed
Section 4.4: this section has been re-formatted, by splitting the information into the following sub-headings ‘Systemic effects’ and ‘’Concomitant therapy’.
Section 4.6: this section has been reworded under the sub-headings ‘Pregnancy’ and ‘Lactation’, the information still dictates that the product should not be used during pregnancy and lactation.
Section 4.7: new information has been added related to the elderly patient population.
Section 4.8: this section has been updated in line with the new MedDRA version and has been tabulated for clarity.
Section 5.3: information regards topical ocular administration of brinzolamide in rabbits and information regards urinary bladder tumours has been removed. New statement added related to ‘no special hazards’ based on conventional studies in line with new non-clinical data. In the developmental toxicity studies paragraph new statement has been added at the end stating ‘ During lactation, the no adverse effect level in the offspring was 5 mg/kg/day’.
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