In this paper we have reviewed the position of desmopressin in the treatment of diabetes insipidus. Desmopressin is a synthetic analog of vasopressin, with more pronounced antidiuretic effect. It is treatment of choice in substitution therapy of diabetes insipidus. Its application before sleeping time can reduce nocturnal enuresis, so it has a place in the treatment of enuresis nocturna. Antidiuretic effect of desmopressin is the result of agonistic effect on V2 receptors in the renal tubules. The efficacy and safety of desmopressin in mentioned indications was confirmed in clinical studies.
Body weight variations during toxicological testing can be one of the indicators of the test substance toxic effects. Data on food and water consumption are true indicators of the rate of growth of experimental animals (Stevens & Gallo, 1989). Daily recording of the food and water consumption was done during the acute toxicity testing of HEPALIP FORTE. The study was performed on Wistar rats. The active component of HEPALIP FORTE is EPL substance--essential phospholipids, a natural substance present in every living cell. Essential phospholipids in combination with vitamins have been used in the treatment of liver diseases, dyslipoproteinaemias and intoxications accompanied with liver failure. Statistical analysis of the body weight variations was performed separately, for males and females. The analysis failed to show any significant difference between the groups. There was a significant difference in water consumption between the male group 2M and female groups 3F and 2F in comparison with control groups. Statistical analysis of the variations of food consumption showed a significant difference in all male groups in comparison with control groups, and only in the 3F female group in comparison with a control group. Considering the absence of lethality and the lack of significant influence of the test substance on animal body weights, we concluded that the test substance was not acutely toxic in rats, if applied orally, in single doses of 300 mg/kg, 500 mg/kg and 1000 mg/kg. Significant differences found in food and water consumption suggest a need of their during the future chronic toxicity testing.
Extensive and complete documentation must be presented for marketing authorization of a medicinal product in the EU. Presented documentation should prove quality, safety and efficacy of the medicinal product. It is ensured that the applicant supplies the authorities with complete information. The legislation in Federation of Bosnia and Herzegovina has also taken more steps towards those European directions. The presentation and content of the dossier in the European Union has been redefined. The "old" EU format will be replaced with the Common Technical Document (EU CTD format) agreed in 2000, within the International Conference on Harmonization framework. These two formats are intended to coexist during the transition period until July 2003. The CTD is an internationally agreed upon format for the preparation of a well structured presentation for applications to be submitted to regulatory authorities in the three ICH regions of Europe, US and Japan.
Introduction: The main aim of the study was to examine the interdependence of values of the nutrition index, the use of medicaments, and alcohol consumption in the group of subjects with post-traumatic stress disorder (PTSD) and in control group without PTSD. Methods: To determine the interdependence of different indices of nutrition and the alcohol and drug consumption in both groups, the crosstab model was used. Results: In both of the tested groups, medicament users had higher average values for nutritional indexes compared to the subjects that are not the consumers of medicaments, but the confirmed differences were not statistically significant. The subjects with PTSD who consume alcohol had lower average values for nutritional indexes compared to the subjects who do not consume alcohol. In the control group, subjects who consumed alcohol had higher mean values for nutritional indexes than those who did not consume alcohol. Differences in the values of the nutrition index between alcohol and non-alcohol subjects were not statistically significant either in the PTSD group or in the control group. The subjects with PTSD had less average values of all the used nutrition indexes compared to the control group subjects, but the confirmed differences were not statistically significant. Conclusion: Our results indicate that medicaments use and alcohol consumption do not exert a statistically significant effect on the values of the nutrition index in any of the study groups. Possible concomitant use of drugs with the opposite effect on the monitored parameter (nitrazepam and amitriptyline vs. SSRI and bupropion) can lead to findings like this. We recommend further research to eliminate influence of pharmacodynamic effects of alcohol, drugs, and stress on the development of weight gain or loss.
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