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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
Thu Feb 16 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Phytosterol Profile in Iraqi Lactuca serriola after Purification and Isolation by Combiflash and HPLC (Conference Paper )#
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One of these plants utilized in traditional medicine is Lactuca seriolla Linn., which belongs to the Asteraceae family. It goes by a variety of common names in the world, including prickly lettuce, wild lettuce, jagged lettuce, and Kahu and khas. The work aimed to isolate and characterize some bioactive constituent(s) from the aerial part of Lactuca serriola utilizing  Combiflash NEXTGEN and high-performance liquid chromatography (HPLC). Lactuca serriola (aerial part) was extracted with 80% ethanol, then fractionated with hexane. Then 250 mg of hexane extract was mixed with 4 g of silica gel and loaded in cartilage, then bounded to the gold column of combi flash using a solvent system comprised of ethyl acetat

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Publication Date
Sat Nov 30 2024
Journal Name
The Journal Of Infection In Developing Countries
Hematological profile among cutaneous leishmaniasis patients before and after treatment with sodium stibogluconate in Diyala, Iraq
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Introduction: Cutaneous leishmaniasis (CL) is a common protozoan disease in Iraq characterized by localized ulcers, primarily on exposed skin. This study aimed to investigate the hematological parameters of infected patients using a complete blood count (CBC) in the endemic area of Diyala Governorate, northeast of Baghdad. This has been studied in newly diagnosed, untreated individuals and patients receiving sodium antimony gluconate. Methodology: Hematological screening was performed on blood samples from 161 patients with microscopically diagnosed cutaneous leishmaniasis before and after treatment. Anti-Leishmania IgG was also assessed by ELISA in seropositive and seronegative subjects. Results: The newly diagnosed, untreated pati

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Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
Efficiency and Safety of Desferioxamine Chelation Therapy in Paediatric Patients with Transfusion-Dependent Anaemia: Experience of two Centres from Sudan
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Background: Repeated blood transfusion   is   the main   therapeutic option for transfusion-dependent anaemias with consequent iron overload and organ damage .Therefore iron chelating agents are important protective measures for these patients. The aim of this study was  to investigate  the efficiency and safety of Desferroxamine  in paediatrics population subjected  to iron overload as a consequence  of repeated transfusion in a group of  Sudanese children  

Subjects & Methods: This was a descriptive cross-sectional hospital based study.  Conducted in two main paediatric reference hospitals   in, Su

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Publication Date
Sun Mar 06 2016
Journal Name
Baghdad Science Journal
Assessment of Pro Hepcidin and Related with Iron Profile on Hemodialysis Men Patients
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Patients with renal failure in the final stages undergo the treatment by hemodialysis. Hemodialysis is used to reinstate the intracellular and extracellular fluid environment, by propagation of molecules in solution through a semipermeable membrane along an electrochemical concentration gradient. Blood catching in the dialysis machine and the recurrent phlebotomy may lead to losing about 1-3 g of iron per year. Prohepcidin hormone is an acute phase protein (type II) that plays a major role in the systemic iron irregularities as it is a mediator of anemia in inflammation and regulator of iron metabolism. This study aims to evaluate the effect of hemodialysis on iron hemostasis and its relationship with prohepcidin as an inflammatory mark

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Publication Date
Sun Jul 28 2019
Journal Name
Journal Of Global Pharma Technology
Synthesis, Characterization, Thermal Study, Biological Activity and Corrosion Inhibition of New Ligand Derived from Butanedioyl Dichloride and Some Selective Transition Metal Complexes
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The new ligand [N1,N4-bis((1H-benzo[d]Glyoxalin-2-yl)carbamothioyl)Butanedi amide] (NCB) derived from Butanedioyl diisothiocyanate with 2-aminobenz imidazole was used to prepare a chain of new metal complexes of Cr(III), Mn(II), Co(II), Ni(II), Cu(II), Pd(II), Ag(I), Cd(II) by general formula [M(NCB)]Xn ,Where M= Cr(III), n=3, X=Cl; Mn(II), Co(II), Ni(II), Cu(II), Pd(II), Cd(II) ,n=2 , X=Cl; Ag(I), n=1, X=NO3. Characterized compounds on the basis of 1H, 13CNMR (for (NCB), FT-IR and U.V spectrum, melting point, molar conduct, %C, %H, %N and %S, the percentage of the metal in complexes %M, Magnetic susceptibility, thermal studies (TGA),while its corrosion inhibition for mild steel in Ca(OH)2 solution is studied by weight loss. These measureme

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Publication Date
Sat Sep 03 2022
Journal Name
International Journal Of Health Sciences
Biological treatment of hydrocarbons contaminated soil by Serratia ficaria
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Petroleum is one of the most important substances consumed by man at present times, a major energy source in this century, petroleum oils can cause environmental pollution during various stages of production, transportation, refining and use, petroleum hydrocarbons pollutions ranging from soil, ground water to marine environment, become an inevitable problem in the modern life, current study focused on bioremediation process of hydrocarbons contaminants that remaining in the bottom of gas cylinders and discharged to the soil. Twenty-four bacterial isolates were isolated from contaminated soils all of them gram negative bacteria, bacterial isolates screening to investigate the ability of biodegradation of hydrocarbons, these isolates

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Publication Date
Mon Jan 01 2018
Journal Name
Al-mustansiriyah Journal Of Science
Relationship of Obesity to Serum Ferritin, Lipid Profile, uric acid and urea at Obesity Medical Center in Iraq
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Publication Date
Tue Dec 01 2020
Journal Name
Egyptian Journal Of Medical Human Genetics
Association between ABO blood groups and susceptibility to COVID-19: profile of age and gender in Iraqi patients
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Abstract<sec> <title>Background

A case-control study was performed to examine age, gender, and ABO blood groups in 1014 Iraqi hospitalized cases with Coronavirus disease 2019 (COVID-19) and 901 blood donors (control group). The infection was molecularly diagnosed by detecting coronavirus RNA in nasal swabs of patients.

Results

Mean age was significantly elevated in cases compared to controls (48.2 ± 13.8 vs. 29.9 ± 9.0 year; probability [p] < 0.001). Receiver operating characteristic anal

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Publication Date
Tue Jun 30 2015
Journal Name
Al-kindy College Medical Journal
Estimation of vitamin E level and its relation to lipid profile in patients with type II Diabetes Mellitus
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Background: Type 2 diabetes mellitus (T2DM) is considered a global disease as it affects over 150 million people worldwide, a number that is supposed to be doubled by 2025. High glucose levels, in vitro, appear to raise the extent of LDL oxidation, and glycated LDL is more prone to oxidative modification.Objective: To investigate the relationship between serum level of vitamin E and lipid profile in patients with type II DM.Methods: This study involved 28 patients suffering from type II DM diagnosed 1-4 years ago and with age ranged from 17 -60 years old, with different residence around Basra ; In addition to 56 apparently healthy persons matched in age and sex to the patients as a control group. The medical histories were taken and Gene

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Publication Date
Mon Jun 30 2014
Journal Name
Al-kindy College Medical Journal
The prevalence and antimicrobial sensitivity of Esbl Escherichia Coli. in clinical isolates
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Background: The antimicrobial resistance is one of the most serious and expanding health problems world -wide in the last decades. The esbl escherichia coli. (extended – spectrum beta-lactamase e.coli) represents an important aspect of it .Objectives: To get an overview on the esbl e.coli prevalence profile in general. Also to assess the antibiotic sensitivity of esbl e. coli trying to specify the most effective antibiotics in combating this micro-organism.Methods: this study tries to focus on this problem in Iraq which through a prospective study approach by taking 35 clinical samples from various sources (urine, blood, abscess, eye ,vagina ,stool and others),and after confirming the presence of e.coli, the presence of esbl e.coli and

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