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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 Dec 30 2021
Journal Name
Al-kindy College Medical Journal
Knowledge, Attitude, and Practice of Nurseries' Workers toward Infection Prevention among the Children
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Background: Infections are common in the children attending daycare centers how act as predisposes to it. Hygienic interventions have a fundamental role in infection control and disease prevention in child care settings.

Objective: - To evaluate the knowledge, attitude, and practice of nurseries workers in infection prevention and control among the children.

Subjects and Methods: A cross-sectional study using the researcher-developed questionnaire validated by two experts and piloted and 100 nurseries-workers had participated in it.

Result: the mean age of participants was 37.5 years±12.1, (37%) aged 18-30 yrs, 58% married, and 57% with higher education, 54% of n

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Publication Date
Sun Sep 22 2019
Journal Name
Baghdad Science Journal
Detection of CTX-M-type ESBLs from Escherichia coli Clinical Isolates from a Tertiary Hospital, Malaysia
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The present study aims to detect CTX-M-type ESBL from Escherichia coli clinical isolates and to analyze their antibotic susceptibility patterns. One hundred of E. coli isolates were collected from different clinical samples from a tertiary hospital. ESBL positivity was determined by the disk diffusion method. PCR used for amplification of CTX-M-type ESBL produced by E. coli. Out of 100 E. coli isolates, twenty-four isolates (24%) were ESBL-producers. E. coli isolated from pus was the most frequent clinical specimen that produced ESBL (41.66%) followed by urine (34.21%), respiratory (22.23%), and blood (19.05%).  After PCR amplification of these 24 isolates, 10 (41.66%) isolates were found to possess CTX-M genes. The CTX-M type ESBL

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Serum Level Profile and Pharmacokinetic Parameters of Single Oral Dose of Metronidazole in Type II Diabetic Patients
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Many pathophysiological processes can affect the pharmacokinetic properties of drugs in people with diabetes. The present study was deigned to evaluate the influence of diabetes mellitus (DM) on the pharmacokinetic parameters of metronidazole administered as single oral dose. Twelve healthy volunteers and twelve diabetic patients were enrolled in the present study. On day 1, a single oral dose of metronidazole 500 mg was administered orally to all participants at 9:00 am after a 10-hour fasting. Over the following 48 hours, blood samples were taken at frequent intervals and serum metronidazole concentrations were measured by a high-performance liquid chromatography method for assessment of pharmacokinetics of metronid

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Publication Date
Sat Jan 01 2011
Journal Name
Iraqi J Pharm Sci,
Serum Level Profile and Pharmacokinetic Parameters of Single Oral Dose of Metronidazole in Type II Diabetic Patients
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Many pathophysiological processes can affect the pharmacokinetic properties of drugs in people with diabetes. The present study was deigned to evaluate the influence of diabetes mellitus (DM) on the pharmacokinetic parameters of metronidazole administered as single oral dose. Twelve healthy volunteers and twelve diabetic patients were enrolled in the present study. On day 1, a single oral dose of metronidazole 500 mg was administered orally to all participants at 9:00 am after a 10-hour fasting. Over the following 48 hours, blood samples were taken at frequent intervals and serum metronidazole concentrations were measured by a high-performance liquid chromatography method for assessment of pharmacokinetics of metronidazole. The data

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Publication Date
Sat Jul 01 2023
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The impact of the practice of professional doubt on the quality of the auditor's performance in Iraq: بحث استطلاعي
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              Due to the increasing interest in the quality of auditing by writers, researchers and regulators of the auditing profession. The matter necessitated a statement of the extent to which the auditor practices professional skepticism, because of its significant impact in discovering errors and material misrepresentations contained in the financial statements in order to give the financial community confidence in them and the success of the audit process. The research aims to clarify the concept and importance of the practice of professional skepticism and its effect on the quality of the auditor's performance in Iraq. To achieve the research objectives, the two re

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Publication Date
Wed Feb 28 2018
Journal Name
International Journal Of Science And Research (ijsr)
Synthesis, Structure Determination and Biological Study of Some Complexes of New Ligand Derived from L-ascorbic Acid
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2,2'-(1-(3,4-bis(carboxydichloromethoxy)-5-oxo-2,5-dihydrofuran-2-yl)ethane-1,2-diyl)bis(oxy)bis(2,2-dichloroacetic acid) a derivative of L-ascorbic acid was prepared by reaction of L-ascorbic acid with trichloroacetic acid (1:4) ratio, in the presence of potassium hydroxide. A series of new metal complexes of this ligand were prepared by a reaction with the chlorides of Cd(II), Co(II), Ni(II), Cu(II) and Zn(II). The new ligand and its complexes were identified by C.H.N., IR, UV-visible spectra, Thermogravimetric analysis (TGA), as well as 1H, 13C-NMR and Mass spectra for ligand L. The complexes were also identified by molar conductance, atomic absorption, magnetic susceptibility and X-ray diffraction for Cu (II) complex. FT-IR spectra

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Publication Date
Thu Jul 01 2021
Journal Name
International Journal Of Drug Delivery Technology
Synthesis and Diagnosis of Some Derivatives of 1,2,4-Triazole-3-Dicarboxylic Acid and Study their Biological Activity
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Newly prepared derivatives of Heterocyclic of dicarboxylic acid include 1, 2, 4-Triazoledicarboxylic acid. Thiocarbohydrazine (TCH) reacts with aliphatic and aromatic dicarboxylic acids, and when these resulting compounds interact with compounds containing a group of carbonyl they result in Schiff base, which are very important in the industrial and medical fields and the acids used (oxalic acid, succinic, terephthalic) to prepare the triazole, then the reaction with Para-chlorobenzendihaide. and some physical properties were measured for these products. The biological activity of the prepared compounds has been studied, and it has been shown that they have different effects on the bacteria, compounds prepared with Fourier Transform Infrare

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Publication Date
Sat Jan 01 2022
Journal Name
Journal Of Pharmaceutical Negative Results
The Effect of Ferric Citrate in Controlling Iron Deficiency Anemia and its Tolerability in a Sample of Iraqi Hemodialysis Patients: Randomized Controlled Clinical Trial
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Background: The iron deficiency anemia along with hyperphosphatemia are the main complications of dialysis patients. Traditional iron supplement has been failed to correct iron deficiency anemia, therefore, the current study aimed to investigate the efficacy and tolerability of new phosphate binder, ferric citrate, in a sample of Iraqi patients with end stage renal disease on maintenance hemodialysis. Method: Prospective, randomized, open label, active controlled trial was conducted in one center for dialysis in Babylon governance. Patients were randomized to receive ferric citrate with dose of 6 g/d and calcium carbonate with dose of 3 g/d for eight weeks. Hemoglobin concentration, mean corpuscular hemoglobin concentration and count o

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Publication Date
Thu Jun 25 2020
Journal Name
International Journal Of Drug Delivery Technology
The Effects of Salvia officinalis Gel as an Adjunct to Scaling and Root Planning in Patients with Periodontitis (Clinical and Immunological Study)
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Background: Phytotherapy is the usage of herbal species with medicinal properties for the management of various diseases. Gingivitis and periodontitis are diseases that involve the role of both the bacteria and the host immune response. Over the years, various researches have shown the importance of herbal products in the management of periodontal diseases. Aims of the study: To evaluate the efficacy of locally applied Salvia officinalis gel as adjunctive in the treatment of chronic periodontitis. Subjects and methods: Fourteen patients (10 males and 4 females) with chronic periodontitis were enrolled in the present study with total number of twenty-eight periodontal pockets utilizing a split mouth design, the pockets were divided i

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Publication Date
Sun Jun 12 2022
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Understanding the Experience of Hospital Pharmacists with the Effectiveness, Safety, Adverse Drug Reaction Reporting and Interchangeability of Biopharmaceutical Medicines
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The study objectives were to 1) explore the real-world experience of hospital pharmacists with the differences in effectiveness safety, and interchangeability between biosimilar medicines and their reference biological counterparts, 2) reveal pharmacist recommendations to enhance the safety of biopharmaceutical medicines in public hospitals.

The study has a mixed-method design where the core component was qualitative (interviews) and the supplemental component was quantitative (adverse drug reaction, ADR, reports). This qualitative component included semi-structured (mostly face-to-face) interviews involving hospital pharmacists from different hospitals with experience with biological or biosimilar medicines. The interviews were c

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