-wording in the Patient Card Drug-drug interaction with -routine pharmacovigilance immunosuppressants with a -special form to follow-up cases narrow therapeutic index metabolised by CYP3A4 -IMS Disease Analyzer data will be collected for the analysis (ciclosporin, tacrolimus, of medical disease sate and concomitant sirolimus, everolimus) medications. -wording in the Patient Card Drug-drug PK interaction -routine pharmacovigilance between ranolazine and metformin Male infertility -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information Use in pregnant or lactating -routine pharmacovigilance women and the paediatric -IMS Disease Analyzer data will be collected for identifying population this missing information Ethnicity other than Caucasian -routine pharmacovigilance: If ethnicity data is volunteered, these data will be collected and included in the individual case reports and PSURs Safety information for patients -routine pharmacovigilance with moderate or severe hepatic impairment Safety information for patients -routine pharmacovigilance with severe and end-stage renal disease requiring dialysis Drug-drug interactions with -routine pharmacovigilance Ia and Class III -IMS Disease Analyzer data will be collected for identifying antiarrhythmics except this missing information amiodarone -wording in the Patient Alert Card Antihistamines (for example -routine pharmacovigilance terfenadine, astemizole, -IMS Disease Analyzer data will be collected for identifying mizolastine), certain this missing information antiarrhythmics (for example quinidine, disopyramide, -wording in the Patient Alert Card procainamide), erythromycin, and tricyclic antidepressants (for example imipramine, doxepin, amitriptyline) Real-world safety information -routine pharmacovigilance for drug-drug interactions with -IMS Disease Analyzer data will be collected for identifying potent CYP3A4 inhibitors which this missing information may cause ranolazine plasma concentration increases -wording in the Patient Card
-wording in the Patient Card Drug-drug interaction with immunosuppressants with a narrow therapeutic index metabolised by CYP3A4 (ciclosporin, tacrolimus, sirolimus, everolimus) -routine pharmacovigilance -special form to follow-up cases -IMS Disease Analyzer data will be collected for the analysis of medical disease sate and concomitant medications. -wording in the Patient Card Drug-drug PK interaction between ranolazine and metformin -routine pharmacovigilance Male infertility -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information Use in pregnant or lactating women and the paediatric population -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information Ethnicity other than Caucasian -routine pharmacovigilance: If ethnicity data is volunteered, these data will be collected and included in the individual case reports and PSURs Safety information for patients with moderate or severe hepatic impairment -routine pharmacovigilance Safety information for patients with severe and end-stage renal disease requiring dialysis -routine pharmacovigilance Drug-drug interactions with Ia and Class III antiarrhythmics except amiodarone -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information -wording in the Patient Alert Card Antihistamines (for example terfenadine, astemizole, mizolastine), certain antiarrhythmics (for example quinidine, disopyramide, procainamide), erythromycin, and tricyclic antidepressants (for example imipramine, doxepin, amitriptyline) -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information -wording in the Patient Alert Card Real-world safety information for drug-drug interactions with potent CYP3A4 inhibitors which may cause ranolazine plasma concentration increases -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information -wording in the Patient Card
auspar-ranolazine-180220.docx