Browsing by Subject "safety"

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  • Gonzalez, Silvia A.; Sarmiento, Olga L.; Lemoine, Pablo D.; Larouche, Richard; Meisel, Jose D.; Tremblay, Mark S.; Naranjo, Melisa; Broyles, Stephanie T.; Fogelholm, Mikael; Holguin, Gustavo A.; Lambert, Estelle V.; Katzmarzyk, Peter T. (2020)
    Walking and biking to school represent a source of regular daily physical activity (PA). The objectives of this paper are to determine the associations of distance to school, crime safety, and socioeconomic variables with active school transport (AST) among children from five culturally and socioeconomically different country sites and to describe the main policies related to AST in those country sites. The analytical sample included 2845 children aged 9-11 years from the International Study of Childhood Obesity, Lifestyle and the Environment. Multilevel generalized linear mixed models were used to estimate the associations between distance, safety and socioeconomic variables, and the odds of engaging in AST. Greater distance to school and vehicle ownership were associated with a lower likelihood of engaging in AST in sites in upper-middle- and high-income countries. Crime perception was negatively associated to AST only in sites in high-income countries. Our results suggest that distance to school is a consistent correlate of AST in different contexts. Our findings regarding crime perception support a need vs. choice framework, indicating that AST may be the only commuting choice for many children from the study sites in upper-middle-income countries, despite the high perception of crime.
  • Nurmatov, U.; Dhami, S.; Arasi, S.; Pajno, G. B.; Fernandez-Rivas, M.; Muraro, A.; Roberts, G.; Akdis, C.; Alvaro-Lozano, M.; Beyer, K.; Bindslev-Jensen, C.; Burks, W.; du Toit, G.; Ebisawa, M.; Eigenmann, P.; Knol, E.; Mäkelä, Mika; Nadeau, K. C.; O'Mahony, L.; Papadopoulos, N.; Poulsen, L. K.; Sackesen, C.; Sampson, H.; Santos, A. F.; van Ree, R.; Timmermans, F.; Sheikh, A. (2017)
    Background: The European Academy of Allergy and Clinical Immunology (EAACI) is developing Guidelines for Allergen Immunotherapy (AIT) for IgE-mediated Food Allergy. To inform the development of clinical recommendations, we sought to critically assess evidence on the effectiveness, safety and cost-effectiveness of AIT in the management of food allergy. Methods: We undertook a systematic review and meta-analysis that involved searching nine international electronic databases for randomized controlled trials (RCTs) and nonrandomized studies (NRS). Eligible studies were independently assessed by two reviewers against predefined eligibility criteria. The quality of studies was assessed using the Cochrane Risk of Bias tool for RCTs and the Cochrane ACROBAT-NRS tool for quasi-RCTs. Random-effects meta-analyses were undertaken, with planned subgroup and sensitivity analyses. Results: We identified 1814 potentially relevant papers from which we selected 31 eligible studies, comprising of 25 RCTs and six NRS, studying a total of 1259 patients. Twenty-five trials evaluated oral immunotherapy (OIT), five studies investigated sublingual immunotherapy, and one study evaluated epicutaneous immunotherapy. The majority of these studies were in children. Twenty-seven studies assessed desensitization, and eight studies investigated sustained unresponsiveness postdiscontinuation of AIT. Meta-analyses demonstrated a substantial benefit in terms of desensitization (risk ratio (RR) = 0.16, 95% CI 0.10, 0.26) and suggested, but did not confirm sustained unresponsiveness (RR = 0.29, 95% CI 0.08, 1.13). Only one study reported on disease-specific quality of life (QoL), which reported no comparative results between OIT and control group. Meta-analyses revealed that the risk of experiencing a systemic adverse reaction was higher in those receiving AIT, with a more marked increase in the risk of local adverse reactions. Sensitivity analysis excluding those studies judged to be at high risk of bias demonstrated the robustness of summary estimates of effectiveness and safety of AIT for food allergy. None of the studies reported data on health economic analyses. Conclusions: AIT may be effective in raising the threshold of reactivity to a range of foods in children with IgE-mediated food allergy whilst receiving (i.e. desensitization) and post-discontinuation of AIT. It is, however, associated with a modest increased risk in serious systemic adverse reactions and a substantial increase in minor local adverse reactions. More data are needed in relation to adults, long term effects, the impact on QoL and the cost-effectiveness of AIT.
  • Mäkinen, Arttu (Helsingfors universitet, 2018)
    This is a systematic review aiming to investigate the efficacy, effectiveness, and safety of biosimilars in the treatment of inflammatory bowel diseases. Biosimilar drugs used to treat inflammatory bowel diseases include biosimilar infliximab and biosimilar adalimumab. Biosimilar infliximab has been authorized by the European Medicines Agency (EMA) in 2013 and by the US Food and Drug Administration (FDA) in 2016. Biosimilar adalimumab has been authorized by EMA and FDA in 2017 and, at the time the literary search for this systematic review was conducted no studies were found regarding the treatment of adalimumab biosimilar for inflammatory bowel diseases. To acquire marketing authorization for biosimilars, it must be proven that the biosimilar is biologically similar to the original medicinal product. Bioequivalence is demonstrated through physicochemical trials and clinical trials. However, clinical trials do not have to be performed with all of the indications for which the original medical product is registered. After proving bioequivalence with one or more indication it is possible to extrapolate the biosimilar to be used in all of the original medical products indications. This has raised the question of whether biosimilars are really comparable to the originator in indications for which no clinical trials have been conducted. This systematic review was implemented using the Cochrane Handbook for Systematic Reviews and Interventions. Systematic literature searches were made in Cochrane, Medline (Ovid®), PubMed and Scopus databases on 12.05.2017. 14 observational studies, one systematic review and a randomized clinical trial that met the inclusion criteria were included in the systematic review. The quality of the publications was evaluated using the STROBE-, NOS- and CONSORT-checklists and information regarding the efficacy, effectiveness and safety of biosimilars was extracted. CD-patients receiving tumor necrosis factor alpha inhibitors for the first time, the clinical response was achieved in 50.0 % to 97.2 % of patients depending on patient population and the duration of treatment. Similarly, for UC-patients, the clinical response was achieved in 62.2 % to 100.0 %. The clinical remission was achieved among 28.9 % to 84.4 % of CD-patients and among 28.9 % to 84.4 % of UC-patients, depending on patient population and treatment follow-up. After the switch from original infliximab to biosimilar, the proportion of patients in clinical remission during follow-up ranged from 62.3 % to 100.0 % in CD-patients and from 45.5 % to 100.0 % in UC-patients. Clinical remission was sustained throughout the whole follow-up in 70 % to 100 % of CD-patients and 66.7 % to 92.0 % of UC-patients. The incidence of adverse events leading to the discontinuation of drug treatment was between 0.0 % and 25.0 %, and the incidence of all adverse events ranged from 0.0 % to 93.6 % in CD- and UC-patients. Biosimilar infliximab seems to be comparable to the original product regarding the efficacy, effectiveness and safety. This result is supported by the systematic literature review published earlier. Conducting a meta-analysis of the information contained in this systematic literature review could have led to a more final decision considering efficacy, effectiveness and safety of biosimilar-infliximab in the treatment of inflammatory bowel diseases.
  • Fu, Y; Qiao, W; Zhu, D; Wang, X; Liu, F; Xu, H; Saris, Per Erik Joakim; Kuipers, Osacar; Qiao, Mingqiang (2018)
    Nisin, an important bacteriocin from Lactococcus lactis subsp., is primarily active against various Gram-positive bacteria. Leucocin C, produced by Leuconostoc carnosum 4010, is a class IIa bacteriocin used to inhibit the growth of Listeria monocytogenes. Because two bacteriocins have different modes of action, the combined use of them could be a potential strategy for effective inhibition of foodborne pathogens. In this study, L. lactis N8-r-lecCI (N8 harboring lecCI gene) coexpressing nisin–leucocin C was constructed based on the food-grade carrier L. lactis N8. Production of both bacteriocins was stably maintained. Antimicrobial measurements showed that the recombinant strain is effectively against Listeria monocytogenes and Staphylococcus aureus and moderately against Salmonella enterica serovar Enteritidis and Escherichia coli because of its stronger antibacterial activity than the parental strain, this result first demonstrated that the co-expression of nisin and leucocin C results in highly efficient antimicrobial activity. The checkerboard assay showed that the antibacterial activity of L. lactis N8-r-lecCI supernatant was enhanced in the presence of low concentration of EDTA. Analysis of the scanning electron microscope image showed the biggest cellular morphology change in L. monocytogenes treated with a mixture of EDTA and L. lactis N8-r-lecCI supernatant. The practical effect was verified in pasteurized milk through time-kill assay. The L. lactis N8-r-lecCI strain expressing both nisin and leucocin C has a promising application prospect in pasteurized milk processing and preservation because of its strong antibacterial activity.
  • Chambers, Philip (Helsingin yliopisto, 2019)
    Forestry is a hazardous industry globally. Physical conditions, legal frameworks and cultural norms can vary from country to country leading to different approaches to site safety management. There are international, national and regional legislation and guidelines which outline normative approaches land managers can utilise to protect forestry machine operators and the public from accident or injury. In this study, the approaches the health and safety management in forestry operations are assessed in two countries within the European Union –Scotland (as part of the UK member state) and Finland. While both countries practice sustainable forest management, it is shown that this is carried out under different legal frameworks leading to differences in approach to site safety planning. Other factors are shown to have an effect including cultural factors and land ownership patterns.
  • Pett, Helmi; Bradley, John; Okebe, Joseph; Dicko, Alassane; Tiono, Alfred B.; Goncalves, Bronner P.; Stone, Will; Chen, Ingrid; Lanke, Kjerstin; Neuvonen, Mikko; Mustaniemi, Anna-Liina; Eziefula, Alice C.; Gosling, Roly; D'Alessandro, Umberto; Drakeley, Chris; Niemi, Mikko; Bousema, Teun (2019)
    Single-dose primaquine (PQ) clears mature gametocytes and reduces the transmission of Plasmodium fakiparurn after artemisinin combination therapy. Genetic variation in CYP2D6, the gene producing the drug-metabolizing enzyme cytochrome P450 2D6 (CYP2D6), influences plasma concentrations of PQ and its metabolites and is associated with PQ treatment failure in Plasmodium vivax malaria. Using blood and saliva samples of varying quantity and quality from 8 clinical trials across Africa (n = 1,076), we were able to genotype CYP2D6 for 774 samples (72%). We determined whether genetic variation in CYP2D6 has implications for PQ efficacy in individuals with gametocytes at the time of PQ administration (n = 554) and for safety in glucose-6-phosphate dehydrogenase (G6PD)-deficient individuals treated with PQ (n = 110). Individuals with a genetically inferred CYP2D6 poor/intermediate metabolizer status had a higher gametocyte prevalence on day 7 or 10 after PQ than those with an extensive/ultrarapid CYP2D6 metabolizer status (odds ratio [OR] = 1.79 [95% confidence interval {CI}, 1.10, 2.90]; P = 0.018). The mean minimum hemoglobin concentrations during follow-up for G6PD-deficient individuals were 11.8 g/dl for CYP2D6 extensive/ultrarapid metabolizers and 12.1 g/dl for CYP2D6 poor/intermediate metabolizers (P = 0. 803). CYP2D6 genetically inferred metabolizer status was also not associated with anemia following PQ treatment (P = 0.331). We conclude that CYP2D6 poor/intermediate metabolizer status may be associated with prolonged gametocyte carriage after treatment with single-low-dose PQ but not with treatment safety.
  • Havunen, Riikka; Kalliokoski, Riikka; Siurala, Mikko; Sorsa, Suvi; Santos, Joao M.; Cervera-Carrascon, Victor; Anttila, Marjukka; Hemminki, Akseli (2021)
    Oncolytic viruses provide a biologically multi-faceted treatment option for patients who cannot be cured with currently available treatment options. We constructed an oncolytic adenovirus, TILT-123, to support T-cell therapies and immune checkpoint inhibitors in solid tumors. Adenoviruses are immunogenic by nature, are easy to produce in large quantities, and can carry relatively large transgenes. They are the most commonly used gene therapy vectors and are well tolerated in patients. TILT-123 expresses two potent cytokines, tumor necrosis factor alpha and interleukin-2, to stimulate especially the T-cell compartment in the tumor microenvironment. Before entering clinical studies, the safety and biodistribution of TILT-123 was studied in Syrian hamsters and in mice. The results show that TILT-123 is safe in animals as monotherapy and in combination with an immune checkpoint inhibitor anti-PD-1. The virus treatment induces acute changes in circulating immune cell compartments, but the levels return to normal by the middle of the treatment period. The virus is rapidly cleared from healthy tissues, and it does not cause damage to vital organs. The results support the initiation of a phase 1 dose-escalation trial, where melanoma patients receiving a tumor-infiltrating lymphocyte therapy are treated with TILT-123 (NCT04217473).
  • Working group for the Dam Safety Code of Practice (National Board of Waters and the Environment, 1994)
    Publications of the Water and Environment Administration - Series B 9E
  • Jämsä, J.O.; Palojoki, S.H.; Lehtonen, L.; Tapper, A.-M. (2018)
    OBJECTIVES: To determine if and in what ways serious patient safety incidents differ from nonserious patient safety incidents. METHODS: Statistical analysis was performed on patient safety incident reports that were reported in 2015 in Finland's largest hospital district (Helsinki and Uusimaa, HUS). Reports were divided into two groups: nonserious incidents and serious incidents. Differences between groups were studied from several types of categorically divided information. RESULTS: Of the total number of reports (15,863), 1% were serious incidents (175). Serious and nonserious incidents differed significantly from each other. Serious incidents concerning laboratory, imaging, or medical equipment were more common. On the other hand, incidents concerning medication, infusion, and blood transfusion were less frequent. In serious incidents, the proportion of doctors reporting was greater, and contributing factors were better recognized, the most common being working of procedures. CONCLUSIONS: In the future, special attention should be given to the particular aspects of serious patient safety incidents, such as safe use of medical equipment, training, and handling of procedures. Root cause analysis is an effective way to handle serious incidents and enables the prevention of their reoccurrence. However, a systematic follow-up of the root cause analysis should be developed. © 2018 American Society for Health Care Risk Management of the American Hospital Association.
  • Vuorio, Alpo; Budowle, Bruce; Sajantila, Antti; Laukkala, Tanja; Junttila, Ilkka; Kravik, Stein E.; Griffiths, Robin (2018)
    After the Germanwings accident, the French Safety Investigation Authority (BEA) recommended that the World Health Organization (WHO) and European Community (EC) develop clear rules for the duty of notification process. Aeromedical practitioners (AMEs) face a dilemma when considering the duty of notification and conflicts between pilot privacy and public and third-party safety. When balancing accountability, knowledge of the duty of notification process, legislation and the clarification of a doctor's own set of values should be assessed a priori. Relatively little is known of the magnitude of this problem in aviation safety. To address this, the National Transportation Safety Board (NTSB) database was searched to identify fatal accidents during 2015 in the United States in which a deceased pilot used a prescribed medication or had a disease that potentially reduced pilot performance and was not reported to the AME. Altogether, 202 finalized accident reports with toxicology were available from (the year) 2015. In 5% (10/202) of these reports, the pilot had either a medication or a disease not reported to an AME which according to the accident investigation was causal to the fatal accident. In addition, the various approaches to duty of notification in aviation in New Zealand, Finland and Norway are discussed. The process of notification of authorities without a pilot's express permission needs to be carried out by using a guidance protocol that works within legislation and professional responsibilities to address the pilot and the public, as well as the healthcare provider. Professional guidance defining this duty of notification is urgently needed.
  • Garcia, Leandro; Johnson, Rob; Johnson, Alex; Abbas, Ali; Goel, Rahul; Tatah, Lambed; Damsere-Derry, James; Kyere-Gyeabour, Elvis; Tainio, Marko; de Sá, Thiago H.; Woodcock, James (Pergamon, 2021)
    Environment International 155, 106680
    Background: Health impact assessments of alternative travel patterns are urgently needed to inform transport and urban planning in African cities, but none exists so far. Objective: To quantify the health impacts of changes in travel patterns in the Greater Accra Metropolitan Area, Ghana. Methods: We estimated changes to population exposures to physical activity, air pollution, and road traffic fatality risk and consequent health burden (deaths and years of life lost prematurely – YLL) in response to changes in transportation patterns. Five scenarios were defined in collaboration with international and local partners and stakeholders to reflect potential local policy actions. Results: Swapping bus and walking trips for car trips can lead to more than 400 extra deaths and 20,500 YLL per year than travel patterns observed in 2009. If part of the rise in motorisation is from motorcycles, we estimated an additional nearly 370 deaths and over 18,500 YLL per year. Mitigating the rise in motorisation by swapping long trips by car or taxi to bus trips is the most beneficial for health, averting more than 600 premature deaths and over 31,500 YLL per year. Without significant improvements in road safety, reduction of short motorised trips in favour of cycling and walking had no significant net health benefits as non-communicable diseases deaths and YLL benefits were offset by increases in road traffic deaths. In all scenarios, road traffic fatalities were the largest contributor to changes in deaths and YLL. Conclusions: Rising motorisation, particularly from motorcycles, can cause significant increase in health burden in the Greater Accra Metropolitan Area. Mitigating rising motorisation by improving public transport would benefit population health. Tackling road injury risk to ensure safe walking and cycling is a top priority. In the short term, this will save lives from injury. Longer term it will help halt the likely fall in physical activity.
  • Vesikari, Timo; Virta, Miia; Heinonen, Seppo; Eymin, Cécile; Lavis, Nathalie; Chabanon, Anne Laure; Gresset-Bourgeois, Viviane (2019)
    ABSTRACTVaccination against influenza during pregnancy provides direct protection to pregnant women and indirect protection to their infants. Trivalent inactivated influenza vaccines (IIV3s) are safe and effective during pregnancy, but quadrivalent inactivated influenza vaccines (IIV4s) have not been evaluated in pregnant women and their infants. Here, we report the results of a randomized phase IV study to evaluate the immunogenicity and safety of IIV4 vs. IIV3 in pregnant women. Participants aged ≥18 years at weeks 20 to 32 of gestation were randomly assigned in a 2:1 ratio to receive a single dose of IIV4 (n = 230) or IIV3 (n = 116). Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3. For the additional B strain in IIV4, HAI titers were higher in IIV4 recipients than IIV3 recipients (post-/pre-vaccination geometric mean titer ratio, 6.3 [95% CI: 5.1 ? 7.7] vs. 3.4 [95% CI: 2.7 ? 4.3]). At delivery, in both groups, HAI antibody titers for all strains were 1.5 ? 1.9-fold higher in umbilical cord blood than in maternal blood, confirming active transplacental antibody transfer. Rates of solicited and unsolicited vaccine-related adverse events in mothers were similar between the two groups. Live births were reported for all participants and there were no vaccine-related adverse events in newborns. These results suggest IIV4 is as safe and immunogenic as IIV3 in pregnant women, and that maternal immunization with IIV4 should protect newborns against influenza via passively acquired antibodies.
  • Björkroth, Johanna (Elsevier, 2004)
    Marinated meat products are consumed increasingly because they are convenient in meal preparing. In addition to sensory effects, marinating has been considered to increase product safety and shelf life quality. There are variations in meat marinating technologies around the world. In Finland, marinades are complex sauces which have a great effect on product appearance and taste. They are water-oil emulsions typically containing salt, sugar and acids (acetic, citric), rheology-improving additives (like xanthan gum and guar gum), antimicrobial agents (like sorbate and benzoate) spices and aroma strengtheners. The pH of these marinades is usually acidic, less than 5, so sugar is used to cut the edge of the acidic taste. Marinated meat products are usually packaged under modified atmospheres to prevent the growth of aerobic spoilage organisms. This results in the growth of psychrotrophic, anaerobic bacteria and lactic acid bacteria (LAB) are the dominating spoilage organisms in these products. Marinating did not increase the shelf life of Finnish poultry products and it strongly selects certain spoilage-associated novel LAB species. Surprisingly, it did not have a strong inhibitory effect on Campylobacter. This may be due to the buffering capability of meat quickly neutralizing the pH of the acidic marinade. The change in the acidic pH towards neutrality also results in dissociation of the lipophilic acids making their antimicrobial effect nonexistent.
  • Venesoja, Anu; Castrén, Maaret; Tella, Susanna; Lindström, Veronica (2020)
    Background Research on patient safety in emergency medical services (EMS) has mainly focused on the organisation's and/or the EMS personnel's perspective. Little is known about how patients perceive safety in EMS. This study aims to describe the patients' experiences of their sense of safety in EMS. Methods A qualitative design with individual interviews of EMS patients (n=21) and an inductive qualitative content analysis were used. Results Patients' experiences of EMS personnel's ability or inability to show or use their medical, technical and driving skills affected the patients' sense of safety. When they perceived a lack of professionalism and knowledge among EMS personnel, they felt unsafe. Patients highlighted equality in the encounter, the quality of the information given by EMS personnel and the opportunity to participate in their care as important factors creating a sense of safety during the EMS encounter. Altogether, patients' perceptions of safety in EMS were connected to their confidence in the EMS personnel. Conclusions Overall, patients felt safe during their EMS encounter, but the EMS personnel's professional competence alone is not enough for them to feel safe. Lack of communication or professionalism may compromise their sense of safety. Further work is needed to explore how patients' perceptions of safety can be used in improving safety in EMS.
  • Vallinkoski, Katja (Helsingin yliopisto, 2014)
    Objectives. School safety has long been a subject of wide-ranging debate, but scientific research on the subject has, however, been rather limited. Although the English language research is comprehensive, in educational sciences school safety has not been a common subject of research. Matti Waitinen's (2011) dissertation is the first school safety culture investigative research in Finland. Waitinen images safety culture of Helsinki comprehensive school, and points out that the differences in security levels can be explained by a different safety cultures. The purpose of this thesis is to find out what are the most common needs to develop safety work that are encountered in comprehensive schools. Research methods. The target group here are four comprehensive schools and their safety groups. The study was carried out as so-called mixed - methods study, where the research data came from both quantitative and qualitative orientation. The data - collection in the first phase of the research was a questionnaire sent to schools, the purpose of which was to orient the school safety team members to the subject. The next step was, Tutor audit, which the Rescue Department of Keski-Uusimaa had developed. The audit, data were generated as quantitative and qualitative, structured group interview section yielded precise values of the school, the level of security, but on the other hand recorded and eventually transcribed conversation around the subject produced a material for the later content analysis. Results and conclusions. Based on the results it can be concluded that the safety work of comprehensive schools found plenty of areas for development. The audits on the basis of the values obtained, it can be said that none of the schools reached in the overall interpretation of the law formed through the minimum requirement, that is, the basic level three. There were found seven development themes: documentation, everyday and communally safety work, risk management, preparedness and independent development of safety, safety skills and safety training, as well as safety communication and paying attention to substitutes and stakeholders. Although the number of results can not be generalized to the comprehensive schools in general, the results can get an understanding of what kind of developments must be done in schools. The general conclusion is that the security work must continue to pay great attention to.
  • Carcao, Manuel; Altisent, Carmen; Castaman, Giancarlo; Fukutake, Katsuyuki; Kerlin, Bryce A.; Kessler, Craig; Lassila, Riitta; Nugent, Diane; Oldenburg, Johannes; Garly, May-Lill; Rosholm, Anders; Inbal, Aida (2018)
    Recombinant factor XIII-A(2) (rFXIII-A(2)) was developed for prophylaxis and treatment of bleeds in patients with congenital FXIII A-subunit deficiency.mentor (TM) 2 (NCT00978380), a multinational, open-label, single-arm, multiple-dosing extension to the pivotal mentor (TM) 1 trial, assessed long-term safety and efficacy of rFXIII-A(2) prophylaxis in eligible patients (patients with severe [<0.05 IU/mL] congenital FXIII subunit A deficiency) aged >= 6 years. Patients received 35IU/kgrFXIII-A(2) (exactdosing) every 28 +/- 2 days for >= 52 weeks. Primary endpoint was safety (adverse events including immunogenicity); secondary endpoints were rate of bleeds requiring FXIII treatment, haemostatic response after one 35 IU/kg rFXIII-A(2) dose for breakthrough bleeds and withdrawals due to lack of rFXIII-A(2) efficacy. Steady-state pharmacokinetic variables were also summarized. Elective surgery was permitted during the treatment period. Sixty patients were exposed to rFXIII-A(2); their median age was 26.0 years (range: 7.0-77.0). rFXIII-A(2) was well tolerated without any safety concerns. No non-neutralizing or neutralizing antibodies (inhibitors) against FXIII were detected. Mean annualized bleeding rate (ABR) was 0.043/patient-year. Mean spontaneous ABR was 0.011/patient-year. No patients withdrew due to lack of efficacy. Geometric mean FXIII trough levelwas 0.17 IU/mL. Geometric terminal half-life was 13.7 days. rFXIII-A(2) prophylaxis provided sufficient haemostatic coverage for 12 minor surgeries without the need for additional FXIII therapy; eight procedures were performed within 7 days of the patient's last scheduled rFXIII-A(2) dose, and four were performed 10 to 21 days after the last dose.
  • Viitanen, Elina (2018)
    It is the responsibility of the marketing authorization holder to assure that the safety and integrity of the medicinal products is not jeopardized during any phase of the manufacturing process, including transportation. In the last resort it is the marketing authorization holder´s decision how the transportation of medicinal products is controlled and safe and good quality products provided to the patiens. Transportation of medicinal products in European Union area is regulated by EU Good distribution Practise (GDP) guidelines. There are different characteristics for different modes of transportation. While the air freight is most often the fastest mode of transportation, it is also most vulnerable for temperature excursions during loading and unloading the aircraft. The road transportation can in best case provide swift door to door delivery, in worst case the road transportation can be time consuming with many different intermediate storaging locations and many loading phases. Road transportation is also the riskiest mode of transportation in matter of crime. In general, the cargo is in danger whenever the vehicle is not moving. While sea freight is the slowest mode of transportation, in some cases it can be suitable for use. With sea freight big amounts of cargo can be transported simultaneously and rather safely even very long distances. Both air and sea freight require additional mode of transportation from and to airport and port. This is called multimodal transportation. Ultimately the decision of the mode of transportation is a compromise with pros and cons from the different modes of transportation. Some of the risks related to transportation process can be mitigated with the proper risk management. One risk management tool is risk assessment. In case of transportation, risk assessment provides a wide look of the whole transportation chain. ----- Myyntiluvan haltijan vastuu on varmistaa, ettei lääkevalmisteiden turvallisuus tai koskemattomuus vaarannu missään valmistusketjun vaiheessa, mukaanlukien lääkevalmisteiden kuljetuksen aikana. Viimekädessä myyntiluvan haltija on vastuussa siitä miten lääkevalmisteidenkuljetusta kontrolloidaan, jotta potilaille voidaan tarjota turvallisia ja laadukkaita lääkevalmisteita. Euroopan Unionin alueella lääkkeiden kuljetuksen viranomaisvaatimukset on säädetty lääkkeiden hyvät jakelutavat (GDP) -ohjeistossa. Eri kuljetusmuodoilla on kaikilla omanlaisensa ominaispiirteet. Siinä missä lentorahti on usein nopein kuljetusmuoto, se on erittäin altis lämpötilan vaihteluille lentokoneen lastaus- ja purkuvaiheissa. Maantiekuljetus voi parhaassa tapauksessa olla nopea ovelta- ovelle kuljetus, mutta pahimmassa tapauksessa kuljetukseen kuluu aikaa ja se voi sisältää useita kuorman lastauksia ja purkuja eri välivarastoihin. Maantikuljetus on myös kuljetusmuodoista kaikkein riskialttein rikoksille. Yleisesti voidaan sanoa, että maantiekuljetuksen lasti on vaarassa silloin kun ajoneuvo ei liiku. Vaikka merirahti on hitain kuljetusmuoto, joissain tapauksissa se voi olla tarkoitukseen parhaiten sopiva. Hitaudesta huolimatta, meriteitse saadaan kuljetettua samanaikaisesti suuria tavaramääriä suhteellisen turvallisesti pitkiäkin välimatkoja. Sekä meri- että lentorahdit vaativat toisenlaisen kuljeutusmuodon käyttöä satamasta tai lentokentältä kohteeseen. Täytä kutsutaan monimuoto-kuljetukseksi. Lopulta päätös kuljetusmuodosta on kompromissi eri kuljetusmuotojen hyvien ja huonojen puolien välillä. Joitakin kuljetukseen liittyviä riskejä voidaan pienentää kunnollisella riskien hallinnalla. Yksi riskien hallinnan työkalu on riskiarvio. Kuljetusten riskiarvio antaa kattavan kuvan koko kuljetusketjusta.
  • EFSA Panel Nutr Novel Foods Food A (2019)
    Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on 2'-fucosyllactose/difucosyllactose (2'-FL/DFL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed of two oligosaccharides, 2'-FL and DFL, which are produced together by fermentation with a genetically modified strain of Escherichia coli K12. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow-on formula, foods for infants and young children, foods for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above 1 year of age. Since the intake of 2'-FL and DFL from the NF at the proposed use levels is unlikely to exceed the intake level of naturally occurring 2'-FL and DFL in breastfed infants per kilogram body weight, the Panel concludes that the NF, a mixture of 2'-FL and DFL, is safe under the proposed conditions of use for the proposed target population. (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Nutr Novel Foods Food; Turck, Dominique; Heinonen, Marina (2020)
    Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on 3'-Sialyllactose (3'-SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human identical milk oligosaccharide (HiMO) 3'-SL but also containing D-lactose, sialic acid and a small fraction of other related oligosaccharides resulting in a fully characterised mixture of carbohydrates. The NF is produced by fermentation with a genetically modified strain of Escherichia coif K-12 DH1. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3'-SL from the NF at the maximum proposed use levels is unlikely to exceed the intake level of naturally occurring 3'-SL in breastfed infants on a body weight basis. The intake of 3'-SL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate-type compounds structurally related to 3'-SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added NF (as well as breast milk, milk, fermented milk-based products and selected cheeses retaining milk sugar (e.g. curd cheese) for infants and young children) are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use for the proposed target populations. (C) 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Nutr Novel Foods Food; Turck, Dominique; Heinonen, Marina (2020)
    Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on 6'-Sialyllactose (6'-SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 6'-SL but also contains D-lactose, sialic acid and a small fraction of other related oligosaccharides. The NF is produced by fermentation with a genetically modified strain of Escherichia coil K-12 DH1. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 6'-SL from the NF at the maximum proposed use levels is unlikely to exceed the intake level of naturally occurring 6'-SL in breastfed infants on a body weight basis. The intake of 6'-SL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate-type compounds structurally related to 6'-SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with the added NF or breast milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. (C) 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.