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Safety Profile of Biological Drugs in Clinical Practice: A Retrospective Pharmacovigilance Study
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Biological drugs have an active substance that is made by a living organism or derived from a living organism. They are one of the important therapy options used in a wide range of diseases especially life-threatening diseases. Biological therapy opens new opportunities for treating different diseases for which drug therapy is minimal, but they have considerable differences in the safety consequences in comparison with non-biological drugs. The aim of the current study was to assess the post-marketing safety profile of biological drugs used in Iraqi hospitals by the analysis of the reported adverse drug reactions regarding their severity, seriousness, preventability, expectedness, and outcome. It is a retrospective study of the individual case safety reports from the Iraqi Pharmacovigilance Center/Ministry of Health. There were 446 individual case safety reports in the research, involving 899 adverse drug reactions. Rituximab was found to be the drug with the highest number of adverse drug reactions with 241 adverse drug reactions (26.81% out of total adverse drug reactions). Most of the adverse drug reactions were related to general disorders and administration site conditions (22.25%). Regarding severity of adverse drug reactions, the majority of adverse drug reactions were observed in moderate levels [Level 4 (26%), and Level 3 (18%)]. The severe adverse drug reactions in patients below 18 years age group were significantly higher compared to adults and elderly. Seriousness assessment showed that the majority of adverse drug reactions were serious (52%). Rituximab was the drug for which the highest number of serious adverse drug reactions was reported (41.28% of total serious adverse drug reactions), Most of the adverse drug reactions (66%) were probably preventable. Fatality outcome was reported for 3% of adverse drug reactions while 43% of adverse drug reactions were recovered/resolved.

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Publication Date
Sun Jul 30 2023
Journal Name
Pakistan Heart Journal
Evaluation of nurses Practice toward Children Safety Post Cardiac Catheterization Procedure
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Publication Date
Sun Oct 01 2006
Journal Name
Journal Of The Faculty Of Medicine Baghdad
Childhood Idiopathic Thrombocytopenic Purpura: A Retrospective Analysis Of Clinical Features And Response To Treatment
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Background : A retrospective study was done in the Pediatric ward /AL-Kadhimiyia Teaching Hospital on cases diagnosed as idiopathic thrombocytopenic Purpura admitted since the first of January1992 – the end of December 2004.
Aim of the study : The objective of this paper is to review the natural history of idiopathic thrombocytopenic Purpura , presenting feature and response to treatment.
Patients and methods : The review included age ,sex , clinical presentation , physical finding , complications , investigation ,treatment and course of the diseases .
Results: total number of the patients were 65, peak age was between (2 -5) years, 40 cases (61.53%). Females were affected more than Males with male: female

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Publication Date
Mon Apr 01 2019
Journal Name
Journal Of Engineering
Investigation of Optimum Heat Flux Profile Based on the Boiling Safety Factor
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An experimental study is conducted to investigate the effect of heat flux distribution on the boiling safety factor of its cooling channel. The water is allowed to flow in a horizontal circular pipe whose outlet surface is subjected to different heat flux profiles. Four types of heat flux distribution profiles are used during experiments: (constant distribution profile, type a, triangle distribution profile with its maximum in channel center, type b, triangle distribution profile with its maximum in the channel inlet, type c, and triangle distribution profile with its maximum in the channel outlet, type d). The study is conducted using heat sources of (1000 and 2665W), water flow rates of (5, 7 and 9 lit/min). The water

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Publication Date
Thu May 10 2018
Journal Name
Global Journal Of Health Science; Issn 1916-9736 E-issn 1916-9744
Effects of Biological and Non Biological Agents (Disease Modifying Antirheumatic Drugs) on Bone Mineral Density in a Sample of Rheumatoid Arthritis Patients
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Background: Osteoporosis is an extra-articular complication of rheumatoid arthritis that results in increased risk of fractures and associated morbidity, mortality, and healthcare costs. Objective: To evaluate changes in bone mineral density in a sample of rheumatoid arthritis (RA) patients on biological (anti tumor necrosis factor (TNF) alpha) and non-biological agent disease modifying antirheumatic drugs (DMARDs). Patients and Methods: A cross sectional study enrolled 60 RA patients diagnosed by rheumatologist according to the 2010 American College of Rheumatology/European League Against Rheumatism (2010 ACR/EULAR) classification criteria for RA. Thirty patient on biological agent (anti TNF alpha) and 30 patient on non-biological agent (D

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Publication Date
Sun Dec 12 2021
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Gender Differences in Adverse Drug Reactions Among Adult Patients Reported to the Iraqi Pharmacovigilance Center
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For many years it was argued that there may be a gender differences in adverse drug reactions (ADRs). This assumption was based on many possible factors such as hormonal or behavior differences, and it was not clearly identified since the female gender was not preferred to be enrolled in many clinical trials. The primary aim of this study was to assess the extent of possibly relevant gender differences in drug–ADRs regarding causality, severity, preventability, seriousness, expectedness and outcome. While the secondary aim was to assess for which group of drugs and for which ADRs gender differences are identified most often. The study was a retrospective one that depends on processing a specially selected group of data obtained from th

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Publication Date
Sun Dec 22 2019
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Assessment of Causality, Severity and Seriousness of Adverse Event Following Immunization in Iraq: A Retrospective Study Based on Iraqi
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Immunization is one of the most cost-effective and successful public health applications. The results of immunization are difficult to see as the incidence of disease occurrence is low while adverse effects following the immunization are noticeable, particularly if the vaccine was given to apparently healthy person. High safety expectations of population regarding the vaccines so they are more prone to hesitancy regarding presence of even small risk of adverse events which may lead to loss of pub

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Publication Date
Wed Aug 24 2022
Journal Name
European Journal Of Research Development And Sustainability
MONKEYPOX A NEW PANDEMIC DISEASE: IMPLICATIONS FOR CLINICAL PRACTICE AND PUBLIC HEALTH EDUCATION. A REVIEW
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Publication Date
Fri Jun 30 2023
Journal Name
Samarra Journal Of Pure And Applied Science
Preclinical Oral Histology Research: A Retrospective Review Study
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A retrospective study is conducted to identify factors that improve prospective animal studies; contribute to the optimization of animal protection from all unnecessary and preventable damage. Preclinical oral histology research from 2010-2020 is evaluated and 64 studies were reviewed relating to two interventions: bone trauma and surgical incision. The harm-benefit analysis is featured in this study through the application of the recent form of Bateson's Cube. Depending on its three axes, we can assess animal suffering, the likelihood of benefit, and the importance of research. The total number of animals used in the research is 2685. Rats, 51.6%, and rabbits, 48.4%, are the most commonly used animals. Research related to bone healing acco

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Publication Date
Sat Dec 31 2022
Journal Name
Al-kindy College Medical Journal
Molecular Microbiology in Clinical Practice: Current and Future Applications: Molecular Microbiology
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Technological advances have yielded new molecular biology-based methods for the diagnosis of infectious diseases.  The newest and most powerful molecular diagnostic tests are available at regional and national reference laboratories, as well as at specialized centers that are certified to conduct metagenomic testing.  Metagenomic assays utilize advances in DNA extraction technology, DNA sequence library construction, high throughput DNA sequencing and automated data analysis to identify millions of individual strands of DNA extracted from clinical samples.  At present, metagenomic assays are only possible at a small number of special research, academic and commercial laboratories.  Continued research in human and path

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Publication Date
Tue Nov 19 2024
Journal Name
Review Of Clinical Pharmacology And Pharmacokinetics - International Edition
Clinical use of tumor necrosis factor-alpha inhibitors in Iraq: a review of their documented efficacy, safety, and associated genetics
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This comprehensive review examines the efficacy and safety of tumor necrosis factor-alpha (TNF-α) inhibitors in treating various autoimmune diseases, and focuses on their application in Iraqi patients. Elevated TNF-α levels are linked to autoimmune disorders, leading to the development of anti-TNF-α therapies such as infliximab, etanercept, adalimumab, certolizumab pegol, and golimumab, which have gained FDA approval for conditions like psoriasis, in¬flammatory bowel disease, ankylosing spondylitis, and rheumatoid arthritis. While these therapies demonstrate sig¬nificant therapeutic benefits, including improved quality of life and disease management, they also carry risks, such as increased susceptibility to infections and pote

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