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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
Fri Oct 01 2010
Journal Name
Saudi Pharmaceutical Journal
Comparative clinical evaluation of ketotifen and montelukast sodium in asthmatic Iraqi patients
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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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Publication Date
Thu Apr 15 2021
Journal Name
Biochem. Cell. Arch.
CYTOKINES SERUM PROFILE IMMUNOSUPPRESSANT BALB/C MICE INFECTED WITH CRYPTOSPORIDIUM PARVUM
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Publication Date
Sun Jul 01 2018
Journal Name
Journal Of Pharmaceutical Sciences And Research
Study of Environmental and Biological characteristics of AL-Chibaish marshes and their effect to the biodiversity of southern Iraq
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The Mesopotamian marshlands faced a massive destruction from many years and this lead to effect to ecosystem. In this study a survey was made on the physical chemical and heavy metals characteristics and microbiological analysis of AL Chibaish marsh during the two months. Water analyses revealed unacceptable values for almost all physiochemical and biological properties, according to WHO standard limits for drinking water. Almost all major ions and heavy metal concentrations in water showed a distinct decreasing trend at the marsh outlet station compared to other stations. In general, major and minor ions, as well as heavy metals exhibit higher concentrations in location 1 than in location 3. The concentrations of heavy metals in water show

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Publication Date
Sat Jun 18 2022
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluation of the Detrimental Effects of some Antiepileptic Drugs on the Height and Weight of Children with Epilepsy
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Growth is a multifactorial process influenced by genetic, nutritional, hormonal, psychosocial and other factors including the general health of a child. Epilepsy defined as a chronic condition characterized by recurrent clinical events or epileptic seizures, which occur in the absence of a metabolic or toxic disease the drugs that use in the treatment of this condition can affect patients growth due to their mechanisms of action. This study aimed to evaluate the effect of some antiepileptic drugs on growth (height and weight) in children with epilepsy. This work involved 51 newly diagnosed children with a different form of epilepsy (Generalized, absent and partial). Patients divided into three groups according to the treatment (group one

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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
Wed Feb 01 2023
Journal Name
Baghdad Science Journal
The Link between Serum Omentin Level and Insulin Resistance Biomarkers, Lipid Profile, and Atherogenic Indices in Iraqi Obese Patients.
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Omentin (or intelectin) is a main visceral fat secretory adipokine.  There is a growing interest to link omentin, obesity and co-morbidity factors. The aim of the present study is to evaluate serum omentin and its association to insulin resistance biomarkers, lipid profile and atherogenic indies. This cross – sectional study was conducted in Obesity Research and Therapy Unit-Alkindy College of Medicine by recruiting (115) individuals; 49 males /66 females. Subjects between (20 to 60) years of age were selected and classified into two groups according to their Body mass index (BMI). Group1 involved healthy lean volunteers (25 male/ 36 female; BMI 18.5 - 24.9). Group2 involved obese subjects; (24 male / 36 female with BMI ≥ 30). The s

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Publication Date
Sun Nov 15 2020
Journal Name
​​​​arabian Journal Of Scientific Research
Isolation and characterization of Candida glabrata from clinical specimens in some hospitals in Baghdad
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This study aimed for isolation and identification of Candida glabrata and identifying some virulence factors. The distribution of patients with candidemia thrush showed that the age group 50-65 years old recorded the highest incidence of candidiasis in female and male with leukemia by 50% and 37.9 % respectively compared to the lowest incidence of candidiasis in the age group under 17 years old in female and male 8.8% and 13.5%, respectively. While the age group between 5-8 years was high, reaching 18 cases of oral candidiasis and 42% of children with leukemia compared with the age group, which was the least, that reached 9 cases, 21%. The highest incidence of C. glabrata was 59 isolates of females and males with leukemia, while C. kefyer w

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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
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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