[PDF] Top 20 SUMMARY OF PRODUCT CHARACTERISTICS
Has 10000 "SUMMARY OF PRODUCT CHARACTERISTICS" found on our website. Below are the top 20 most common "SUMMARY OF PRODUCT CHARACTERISTICS".
SUMMARY OF PRODUCT CHARACTERISTICS
... Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals ... See full document
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EBE Position paper on labelling of biosimilars Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)- draft April 2013
... biosimilar product should fit within the existing framework of headings for SmPCs as diverging from this format would incorrectly imply that such products are more different to other types of products than they ... See full document
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SUMMARY OF PRODUCT CHARACTERISTICS. One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
... Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals ... See full document
8
Summary of Product Characteristics (SmPC) 1. Name of the medicinal product Tramadol STADA 100 mg solution for injection
... Epileptif orm convulsions occurred mainly af ter administration of high doses of tramadol or af ter concomitant treatment w ith medicinal products w hich can low er[r] ... See full document
9
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
... In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum crea[r] ... See full document
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
... Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals ... See full document
11
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
... • In children aged 2 to 5 years that received 1 dose, the ELISA antibody GMCs were similar for 6 vaccine serotypes as well as serotype 19A than those achieved following a 3-dose vacci[r] ... See full document
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
... The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation. Thus, it may be expected that for an IL-1 receptor antagonist, such as anakinra, the formation of ... See full document
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
... To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus[r] ... See full document
164
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
... In 6-month controlled clinical studies, the rate of serious infections with tocilizumab 8 mg/kg plus DMARDs was 5.3 events per 100 patient years exposure compared to 3.9 events per 100 [r] ... See full document
102
Development and evaluation of a computerised clinical decision support system for switching drugs at the interface between primary and tertiary care
... Drugs within a drug-class can differ widely in potency and efficacy [10,11], which has to be considered during exchange to avoid over- and underdosing. Therefore, 21 drug classes were defined eligible for automatic ... See full document
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Patient-reported outcomes item selection for bladder cancer patients in chemo- or immunotherapy
... 3) summary of product characteristics from European Medicines Agency and Food and Drug Administration for the applied chemotherapies, and 4) toxicity reporting from Phase 2 and 3 trials for ... See full document
9
The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized controlled trial
... SPC: summary of product characteristics; SUSAR: suspected unexpected serious adverse reaction; T3: triiodothyronine; T4: thyroxine; TDMS: trial data management system; ThyPRO: Thyroid Pa[r] ... See full document
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FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT
... the product is used in accordance with the Summary of Product Characteristics, the risk benefit profile for the target species is favourable and the quality and safety of the product ... See full document
6
Construct and concurrent validity of a patient-reported adverse drug event questionnaire: a cross-sectional study
... the Summary of Product Characteristics (SPC) of those drugs, and whether patients who report an ADE with the use of metformin on the TSQM, mention metformin as a drug associated with an ADE on the ... See full document
9
Software Quality Models: A Comparative Study
... achieving quality in use [14]. The six fundamental steps of Quality Improvement Paradigms are characterize the project and its environment, set of goals, choose the appropriate processes, execute the processes, analyze ... See full document
10
The Systematic Procedure to Sort Out Contractor in Construction Field
... The initial phase involves the evaluation of the project configuration. The goal of design is to choose the best supplier. There must be a total of four suppliers (called suppliers A, B, C and D) along with eleven ... See full document
5
Consumer market research for optimization of an extruded snack product and process for the Indonesian market : a thesis presented in partial fulfilment of the requirements for the degree of Master of Technology in Food Technology at Massey University
... the product formulation and their effect on the physical, functional and sensory characteristics of the extruded snack product; use linear programming to optimize the cost of a range of [r] ... See full document
306
Product Technology Imitation Over the Product Diffusion Cycle: Which Companies and Product Innovations do Competitors Imitate More Quickly?
... fact, product diffusion is linked to market and technological uncertainty and to competition dynamics, which are two distinctive triggers of information-based and rivalry-based motives for imitation, ...new ... See full document
45
Product Family Shape Based on Similar Characteristics
... form characteristics layer by ...the product structures are different, their forms are different ...the product satisfying their needs from the shape ... See full document
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