Pfizer Limited

Section 2 addition of excipients, 4.6 sentence on fertility added, 4.8 addition of circulatory collapse and reformatting 6.3 amendments to shelf life

9 of the SPC

Section 4.4 (highlighted text = new text)

Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens-Johnson syndrome (some of them fatal) have been reported through post marketing surveillance in patients receiving parecoxib.  Additionally, fatal reports of toxic epidermal necrolysis, have been reported through postmarketing surveillance in patients receiving valdecoxib (the active metabolite of parecoxib) and cannot be ruled out for parecoxib (see section 4.8).

9 – Date of Renewal

10 – Date last updated

2 – addition of amount of sodium when reconstituted (moved from section 6.1)

4.2 – rewording of statement on lack of experience in children and adolescents

4.3 – hypersensitivity statement updated

4.4 – addition of paragraph on association of COX-2 inhibitors with increased risk of 4.4 – cardiovascular and thrombotic adverse events in long term use

4.4 – update to section on serious skin reactions

4.5 – interaction studies have only been performed in adults

4.6 – update to include statement on suspected to cause serious birth defects when administered during the last trimester of pregnancy

4.8 – addition of myocardial infarction and Stevens-Johnson syndrome as rare post-marketing reactions

6.4 – section reworded in line with current guidelines

In addition the details of the non-marketed 20mg presentations have been added to the advert SmPC. This affects sections 1, 2, 6.5, 6.6 and 8.

Section 4.2

Addition of warning regarding preciptation if adding other medicinal products toi reconstituted vials of Dynastat and need to flush IV line if used to administer other products in addition to Dynastat