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besponsa summary of product characteristics

besponsa summary of product characteristics

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besponsa summary of product characteristics
BESPONSA 1 mg powder for concentrate for solution for , Besponsa | European Medicines Agency, ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, Blincyto - Summary of Product Characteristics (SmPC) - (eMC), inotuzumab ozogamicin 1mg powder for concentrate for , ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, Besponsa: Uses, Side Effects, Benefits/Risks | Drugs.com, London, 20 November 2008 - European Commission, ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS.
For patient-reported outcomes, most functioning and symptom scores were in favour of BESPONSA compared to Investigator's choice of chemotherapy. Patient-reported outcomes measured using the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), were significantly better for BESPONSA by estimated mean postbaseline scores (BESPONSA and Investigator's choice of chemotherapy, respectively) for role functioning (64.7 versus 53.4, improvement grade small), physical functioning (75.0 versus 68.1, improvement grade small), social functioning (68.1 versus 59.8, improvement grade medium), and appetite loss (17.6 versus 26.3, improvement grade small) compared to Investigator's choice of chemotherapy. There was a trend in favour of BESPONSA, improvement grade small, for estimated mean postbaseline scores (BESPONSA and Investigator's choice, respectively) in global health status/Quality of Life (QoL) (62.1 versus 57.8), cognitive functioning (85.3 versus 82.5), dyspnoea (14.7 versus 19.4), diarrhoea (5.9 versus 8.9), fatigue (35.0 versus 39.4). There was a trend in favour of BESPONSA for estimated mean postbaseline scores from the EuroQoL 5 Dimension (EQ-5D) questionnaire, (BESPONSA and Investigator's choice of chemotherapy, respectively) for the EQ-5D index (0.80 versus 0.76, minimally important difference for cancer = 0.06).. BESPONSA 1 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) by Pfizer Limited BESPONSA 1 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (eMC). Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Besponsa have been included in the summary of product characteristics and the package leaflet..
4 Dose modifications Dose modification of BESPONSA may be required based on individual safety and tolerability (see section 4.4). Management of some adverse drug reactions may require dosing interruptions and/or. Blincyto - Summary of Product Characteristics (SmPC) by Amgen Ltd BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).. inotuzumab ozogamicin (BESPONSA See the summary of product characteristics (SPC) for further details concerning assessment of CD22 expression, pre-medication and administration. 1: Inotuzumab ozogamicin should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available. 1 . corresponding Summary of Product Characteristics. Infusion rates Following dilution the DARZALEX infusion should be intravenously administered at the initial infusion rate presented in Table4below. Incremental escalation of the infusion rate should be considered only in the absence of infusionreactions. 4 Table4: Infusion rates for DARZALEX administration Dilution volume Initial infusion rate . Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Besponsa have been included in the summary of product characteristics and the package leaflet.. module 1.3 summary of product characteristics Article 8(3)(j) of Directive 2001/83/EC and Article 6(1) of Regulation (EC) 726/2004 require that, in order to obtain a marketing authorisation, a Summary of Product Characteristics (SmPC) in.
 
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