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besponsa spc

besponsa spc

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besponsa spc
BESPONSA 1 mg powder for concentrate for solution for , ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, BESPONSA - inotuzumab ozogamicin, inotuzumab ozogamicin 1mg powder for concentrate for , Inotuzumab ozogamicin – SPS - Specialist Pharmacy Service , Besponsa | Pfizer UK, Medicines.ie | Reliable & Accurate Online Medicines , Besponsa - FDA prescribing information, side effects and uses, Inotuzumab ozogamicin - Wikipedia.
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 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.. dose reductions, or permanent discontinuation of BESPONSA (see sections 4.4 and 4.8). If the dose is reduced due to BESPONSA-related toxicity, the dose should not be re-escalated. Table 2 and Table 3 show the dose modification guidelines for haematological and non-haematological toxicities, respectively. BESPONSA doses within a treatment cycle (i.e. Days 8.
It is proposed that Besponsa be prescribed by physicians experienced in treating cancer. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and. (BESPONSA ®) SMC No 1328/18 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 . Inotuzumab ozogamicin will be given IV weekly (0.8-0.5 mg/m^2) 3 times per cycle. The comparator arms are: fludarabine, cytarabine and G-CSF or high dose cytarabine or cytarabine and mitoxantrone. The study will start in Jun 12 and is due to complete May 16 (primary outcome data available from Aug 14) [1].. Besponsa (inotuzumab ozogamicin) For more information on this product please visit the electronic Medicines Compendium (eMC) This medicine is subject to additional monitoring.. Ireland's most popular source of accurate and reliable medicines information. Search our online medicines database for Summaries of Product Characteristics (known as SPCs or SmPCs) and Patient Information Leaflets (known as PILs, Package Leaflets or Pls).. Discontinue Besponsa if low platelet count persists for greater than 28 days and is suspected to be related to Besponsa. If prior to Besponsa treatment ANC was less than 1 × 10 9 /L and/or platelet count was less than 50 × 10 9 /L *.
 
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