DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)27. CARBIMAZOLEThe following statement shall be included in the package inserts of productscontaining Carbimazole:WARNINGCarbimazole may cause white cell disorders such as neutropenia andagranulocytosis, which may be fatal if treatment with carbimazole is notstopped promptly. These reactions usually occur during the first 3 months oftherapy, and in most cases, are reversible on stopping treatment. Sinceagranulocytosis can develop very rapidly, periodic leucocyte counts alone maynot be effective in the early detection of these reactions.28. CABERGOLINEPlease refer to DOPAMINERGIC INGREDIENT29. CEFTRIAXONEThe following statement shall be included in the package inserts of productscontaining Ceftriaxone:CONTRAINDICATIONCeftriaxone is contraindicated in neonates (≤28 days of age) if they require (orare expected to require) treatment with calcium-containing intravenoussolutions, including calcium-containing infusions such as parenteral nutrition,because of the risk of precipitation of ceftriaxone-calcium.WARNINGIn patients other than neonates, Ceftriaxone and calcium-containingsolutions may be administered sequentially to one another if the infusionlines are thoroughly flushed between infusions with a compatible fluid.Diluents containing calcium, such as Ringer‟s solution or Hartmann‟ssolution, are not to be used to reconstitute Ceftriaxone vials or to furtherdilute a reconstituted vial for intravenous administration because aprecipitate can form. Ceftriaxone must not be administeredsimultaneously with calcium-containing intravenous solutions, includingcontinuous calcium-containing infusions such as parenteral nutrition via aY-site, because precipitation of ceftriaxone-calcium can occur.Reference: Circular Bil (48) dlm. BPFK/PPP/01/03: Pindaan Pada Kenyataan AmaranBerkaitan Dengan "Potential Risk Associated With Concomitant Use Of Ceftriaxone WithCalcium - Containing Intravenous Solutions" Yang Perlu Dimuatkan Pada Sisip BungkusanProduk CeftriaxoneNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 370