viernes, 11 de diciembre de 2015

FDA MedWatch - November 2015 Drug Safety Labeling Changes includes 19 products with revisions to Prescribing Information

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The MedWatch November 2015 Safety Labeling Changes posting includes 19 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections:
0.9% Sodium Chloride Injection, USP in Mini-Bag & Viaflex Container
Aggrenox (aspirin/extended release dipyridamole) Capsules 
Avagard Surgical and Healthcare Personnel Hand Antiseptic (chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w) 
Cefepime for Injection, USP and Dextrose Injection 
Harvoni (ledipasvir/sofosbuvir) Tablet 
Kaletra (lopinavir/ritonavir) Oral Solution and Capsules 
Ketek (telithromycin) Tablet 
Methotrexate Injection (Preservative) and (Preservative-Free) 
Norvir (ritonavir) Oral Solution, Tablets and Soft Gelatin Capsules 
Opdivo (nivolumab) Injection 
Rapamune (sirolimus) Oral Solution and Tablets 
Sarafem (fluoxetine hydrochloride) Capsules 
Treanda (bendamustine hydrochloride) for Injection 
Tybost (cobicistat) Tablet 
Zortress (everolimus) Tablets

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