Balancing information should be part of the body copy.
With respect to comparative drug interactions presentations, detailed and complete drug interaction information for all compared products is required for a fair and complete presentation.
Specific claim relating to sertraline:
ARBACE does not interact with sertraline.
Concentrations of other selective serotonin reuptake inhibitors (SSRIs) may be increased when coadministered with ARBACE. Dose titration may be required for most drugs of the SSRI class and dose reduction should be considered when trazodone is coadministered with ARBACE.
Please see the Product Monograph for contraindications with ergot derivatives (dihydroergotamine, ergonovine, ergotamine), serious interactions with carbamazepine, phenobarbital and phenytoin, and interactions with colchicine, lovastatin, simvastatin, perphenazine and pimozide.
General claim:
Good drug-drug interaction profile.
Please see the Product Monograph for contraindications with ergot derivatives (dihydroergotamine, ergonovine, ergotamine), serious interactions with carbamazepine, phenobarbital and phenytoin, and interactions with SSRIs, trazodone, colchicine, lovastatin, simvastatin, perphenazine and pimozide.
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In an effort to constantly serve our clients better, PAAB has unveiled a new electronic submission process(eFiles). Effective January 2, 2008 all submissions will have to be submitted via the eFiles system. Please have a Senior Official (Director level) send an email to the administration team at review@paab.ca with the contact information of the person(s) who will be designated as administrator(s) for your company. Click on eFiles, on the menu, then eFiles Tutorial for a tutorial on how eFiles works.
Please contact the admin team at PAAB if you need assistance with eFiles
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