natgillin/translations-raw huggingface dataset:
Patients weighing 25 kg or more should receive a total volume of 250 ml.
Bolniki, ki tehtajo 25 kg ali več, morajo prejeti skupno prostornino 250 ml.
Infusion reactions (IRs) were the most commonly observed adverse reactions in clinical studies.
Med kliničnimi študijami so bile z infuzijo povezane reakcije najpogosteje poročani neželeni učinki.
A total of 235 patients with MPS IVA were enrolled and exposed to Vimizim in six clinical studies.
Z zdravilom Vimizim je bilo izvedenih šest kliničnih študij, v katerih je sodelovalo skupno 235 bolnikov z MPS IVA.
People with MPS IVA disease either lack completely or do not have enough N-acetylgalactosamine-6sulfatase, an enzyme which breaks down specific substances in the body such as keratan sulphate, which are found in many tissues of the body, including cartilage and bone.
Ta encim razgrajuje določene snovi v telesu kot je keratansulfat, ki je prisoten v mnogih tkivih v telesu, vključno s hrustancem in kostmi.
• Patients weighing 25 kg or more should receive a total volume of 250 ml.
• Bolniki, ki tehtajo 25 kg ali več, morajo prejeti skupno prostornino 250 ml.
The volume of Vimizim is to be slowly added to the sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Prostornino zdravila Vimizim je treba počasi dodajati raztopini natrijevega klorida za infundiranje 9 mg/ml (0,9 %).
When diluted in 100 ml, the initial infusion rate should be 3 ml/hr.
Če je zdravilo razredčeno s 100 ml vehikla, mora biti začetna hitrost infundiranja 3 ml/uro.
3-Minute stair climb test (stairs/minute)
Triminutni test hoje po stopnicah (stopnic/minuto) Povprečje ± SD
Before dilution, each vial is to be inspected for particulate matter and discolouration.
Pred redčenjem se je treba za vsako vialo prepričati, da ne vsebuje vidnih delcev in da raztopina ni spremeni barvo.
A volume of the sodium chloride 9 mg/ml (0.9 %) solution for infusion is to be withdrawn and discarded from the infusion bag, equal to the volume of Vimizim concentrate to be added.
Iz infuzijske vrečke je treba odvzeti in zavreči prostornino raztopine natrijevega klorida 9 mg/ml (0,9%) za infuzijo, ki ustreza celotni, na telesno maso bolnika preračunani prostornini koncentrata zdravila Vimizim.
Musculoskeletal and connective Myalgia
Bolezni mišično-skeletnega sistema in vezivnega tkiva
Week
Občasni
If not used immediately, in-use storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2C - 8C followed by up to 24 hours at 23C - 27C during administration.
Običajno čas ne sme presegati 24 ur pri temperaturi 2 °C-8 °C in nadalje največ 24 ur pri temperaturi 23 °C-27 °C med dajanjem.
A volume of the sodium chloride 9 mg/ml (0.9 %) solution for infusion is to be withdrawn and discarded from a 100 ml or 250 ml infusion bag equal to the total volume of Vimizim to be added.
Iz 100-ml ali 250-ml infuzijske vrečke se povleče in zavrže prostornino raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje, ki ustreza celotni, na telesno maso bolnika preračunani prostornini zdravila Vimizim.
Preparation of the Vimizim infusion
Delovanje zdravila Vimizim
The infusion rate will be increased every 15 minutes as follows: first increase the rate to 12 ml/hr, then increase the rate every 15 minutes by 12 ml/hr increments until a maximum rate of 72 ml/hr is reached.
Hitrost infundiranja povečajte vsakih 15 minut, in sicer jo najprej povečajte na 12 ml/uro in nato vsakih 15 minut v korakih po 12 ml/uro, dokler ne dosežete največje hitrosti 72 ml/uro.
The infusion rate will be increased every 15 minutes as follows: first increase the rate to 6 ml/hr, then increase the rate every 15 minutes by 6 ml/hr increments until a maximum rate of 36 ml/hr is reached.
Hitrost infundiranja povečajte vsakih 15 minut, in sicer jo najprej povečajte na 6 ml/uro in nato vsakih 15 minut v korakih po 6 ml/uro, dokler ne dosežete največje hitrosti 36 ml/uro.
Step 5 minutes (ml/hr)
5. korak minut (ml/uro)
Step 7 minutes (ml/hr)
7. korak minut (ml/uro)
The infusion rate may be increased as tolerated, every 15 minutes as follows: first increase the rate to 12 ml/hr, then increase the rate every 15 minutes by 12 ml/hr increments until a maximum rate of 72 ml/hr is reached.
Hitrost infundiranja lahko prilagodite vsakih 15 minut glede na toleranco bolnika, in sicer: najprej povečajte hitrost na 12 ml/uro in jo nato vsakih 15 minut povečajte v korakih po 12 ml/uro, dokler ne dosežete največje hitrosti 72 ml/uro.
Step 2 minutes (ml/hr)
2. korak minut (ml/uro)
o all patients should receive antihistamines with or without antipyretics 30-60 minutes prior to the start of infusion o appropriate medical support should be readily available when VIMIZIM® is administered o the need to immediately stop the infusion and initiate appropriate medical treatment if these reactions occurred
o vsi bolniki morajo prejemati antihistaminike z ali brez antipiretikov 30-60 minut pred začetkom infuzije;
Once the product has been diluted it should be used immediately.
Po razredčitvi morate zdravilo nemudoma uporabiti.
Vimizim has to be diluted with sodium chloride 9 mg/ml (0.9 %) solution for infusion using aseptic technique.
Zdravilo Vimizim mora biti po aseptičnem postopku razredčeno z raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
Step 4 minutes (ml/hr)
4. korak minut (ml/uro)
The infusion rate may be increased as tolerated, every 15 minutes as follows: first increase the rate to 6 ml/hr, then increase the rate every 15 minutes by 6 ml/hr increments until a maximum rate of 36 ml/hr is reached.
Hitrost infundiranja lahko prilagodite vsakih 15 minut glede na toleranco bolnika, in sicer: najprej povečajte hitrost na 6 ml/uro in jo nato vsakih 15 minut povečajte v korakih po 6 ml/uro, dokler ne dosežete največje hitrosti 36 ml/uro.
Step 3 minutes (ml/hr)
3. korak minut (ml/uro)
Sodium dihydrogen phosphate monohydrate; Arginine hydrochloride;
Natrijev acetat trihidrat, natrijev dihidrogenfosfat monohidrat, argininijev klorid, sorbitol (E 420), polisorbat 20, voda za injekcije.
Step 6 minutes (ml/hr)
6. korak minut (ml/uro)
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Vsaka viala z zdravilom Vimizim je samo za enkratno uporabo.
Dizziness was reported in some patients during the Vimizim infusion.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri bolniki so poročali o omotici med uporabo infuzije Vimizim.
Aseptic technique is to be used.
Priprava raztopine zdravila Vimizim za infundiranje Uporabiti je treba aseptični postopek.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 5 ml VIAL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
A clear to slightly opalescent and colourless to pale yellow solution.
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra do rahlo opalescentna in brezbarvna do bledo rumena raztopina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Izgled zdravila Vimizim in vsebina pakiranja
Dish cells/cm²
posodica celic/cm²
1 to 2 implantation matrices
1 do 2 matriksa za vsaditev
EU (MA) number (Invented)
Številka (EU) dovoljenja za promet
MA (EU) number
Številka EU ime
In general, it can be concluded that the safety profile seems well characterized.
Na splošno je mogoče zaključiti, da je varnostni profil dobro opredeljen.
Therefore, it is considered that these studies are only supportive.
Zato se šteje, da so te študije le podporne.
Furthermore, residual bias will always be present.
Poleg tega bo vedno prisotna rezidualna pristranskost.
The statistical analysis and interpretation were not robust according to current standards.
Statistična analiza in interpretacija nista bili zanesljivi v skladu z veljavnimi standardi.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the variation of the marketing authorisations.
V skladu s členom 116 Direktive 2001/83/ES odbor zato priporoča spremembo dovoljenj za promet z zdravili.
Both submissions discussed the available data sources and their interpretation.
V obeh vlogah so obravnavali razpoložljive vire podatkov in njihovo razlago.
Although statin use increased during the study, it was only 28 - 29% at 6 months and 44 - 46% at 42 months.
Čeprav je uporaba statinov med študijo naraščala, je po šestih mesecih znašala le 28-29 % in po 42 mesecih 44-46 %.
These products contain 18 to 22 carbon atoms and a varying number of double bonds, the first of which is in the n-3 position.
Ti proizvodi vsebujejo od 18 do 22 ogljikovih atomov in spremenljivo število dvojnih vezi, od katerih je prva na mestu n-3.
With respect to safety, the PRAC concluded in the last PSUSA (January 2017) that no new safety issues had emerged.
Glede varnosti je odbor PRAC v okviru zadnjega postopka PSUSA (januarja 2017) zaključil, da se niso pojavila nobena nova vprašanja v zvezi z varnostjo.
The narrow confidence interval excludes any clinically relevant beneficial effects.
Ozek interval zaupanja izključuje vse klinično pomembne koristne učinke.
Since this was not the case, these can be considered supportive for a lack of efficacy.
Ker ga niso, se to lahko šteje kot dokaz o pomanjkanju učinkovitosti.
Only a limited amount of parameters in these retrospective analyses were available.
V teh retrospektivnih analizah je bilo na voljo le omejeno število parametrov.
It did not reproduce these findings and did not demonstrate efficacy in this indication.
V njem niso mogli ponoviti teh ugotovitev in niso dokazali učinkovitosti pri tej indikaciji.
The recommendations in these guidelines are therefore developed after careful consideration of the scientific and medical knowledge and evidence available at the time of coming into effect.
Priporočila v teh smernicah so torej pripravljena po skrbnem razmisleku o znanstvenem in medicinskem vedenju ter dokazih, ki so bili na voljo ob začetku njihove veljavnosti.
Additionally, the level of evidence in these post-hoc subgroup analyses is not strong.
Poleg tega raven dokazov pri teh post hoc analizah podskupin ni močna.
With any other interpretation about the primary endpoints, multiplicity should have been controlled, which was not the case.
Pri kateri koli drugi interpretaciji primarnih opazovanih dogodkov bi bilo treba kontrolirati številčnost, kar ni bilo narejeno.
These results should, however, be interpreted with caution.
Vendar pa je pri razlagi teh rezultatov potrebna previdnost.
It has also been argued that the OMEGA trial had a too short duration (12 months) to observe beneficial effects.
Podane so bile tudi utemeljitve, da je bilo trajanje preskušanja OMEGA prekratko (12 mesecev), da bi lahko opazili koristne učinke.
Therefore, the proposed modification of the indication is not acceptable by the CHMP.
Odbor CHMP zato predlagane spremembe indikacije ne more sprejeti.
They are essential fatty acids and must be obtained from the diet.
Gre za esencialne maščobne kisline, ki jih moramo pridobiti iz hrane.
This included the responses submitted by the marketing authorisation holders in writing and during an Oral Explanation, as well as the outcome of the consultation with the Cardiovascular Scientific Advisory Group on the 10 of October 2018.
Med njimi so bili odgovori, ki so jih imetniki dovoljenja za promet z zdravili podali v pisni obliki in med ustno obrazložitvijo, ter tudi izidi posvetovanja z znanstveno-svetovalno skupino za srčno-žilna vprašanja 10. oktobra 2018.
Thus, retrospective data in these studies did not allow for appropriate statistical adjustment for confounding.
Zato retrospektivni podatki v teh študijah niso omogočali ustrezne statistične prilagoditve glede na moteče spremenljivke.
Especially selection bias is of concern, as it can be envisaged that omega-3 fatty acids will be prescribed to certain patients (not needing strict treatment immediately).
Zlasti skrb vzbujajoča je selektivna pristranskost, saj je mogoče predvideti, da se bodo omega-3-maščobne kisline predpisovale nekaterim bolnikom (ki strogega zdravljenja ne potrebujejo takoj).
No attempts have been made to adjust for likely differences between centers regarding strategies and ambition for secondary prevention, likely creating correlations within centers.
Poskusov prilagoditve glede na verjetne razlike med centri v strategijah in željah za sekundarno preventivo ni bilo, kar je znotraj centrov verjetno ustvarilo vzporednice.
It should also be noted that the current European guidelines no longer recommend omega-3 supplementation in this indication.
Prav tako je treba upoštevati, da trenutno veljavne evropske smernice dodajanja omega-3-maščobnih kislin pri tej indikaciji ne priporočajo več.
Furthermore, although this post-hoc analysis did not show differences in benefit with or without concomitant statin therapy, potential differences could not be excluded since the study was underpowered for demonstrating such differences.
Nadalje, čeprav ta post hoc analiza ni pokazala razlik v koristih ob sočasnem zdravljenju s statini ali brez njega, potencialnih razlik ni bilo mogoče izključiti, ker je bila študija prešibka za dokazovanje takšnih razlik.
However, in the GISSI-P trial, the effect was most pronounced at earlier time points (<12 months) with no increase thereafter.
Vendar pa je bil v preskušanju GISSI-P učinek najizrazitejši ob zgodnejših časovnih točkah (< 12 mesecev) in se pozneje ni povečeval.
However, later studies, including meta-analyses1,2,3 have failed to show a beneficial effect in this condition.
Vendar pa poznejše študije, vključno z metaanalizami1, 2, 3, niso pokazale koristnega učinka pri tem stanju.
ESC/EAS guidelines are recommendations made by various societies in consultation with task forces, expert groups or consensus panels, with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition taking into account the impact on outcome as well as the risk/benefit ratio of particular diagnostic or therapeutic means.
Smernice ESC/EAS so priporočila različnih združenj, ki so bila pripravljena v posvetovanju z delovnimi skupinami, strokovnimi skupinami ali konsenznimi odbori, da bi pomagala zdravnikom pri izbiri najboljših strategij za obravnavo posameznega bolnika z določenim stanjem ob upoštevanju vpliva na izid ter razmerja med tveganji in koristmi posameznega diagnostičnega ali terapevtskega sredstva.
The study formally failed because the primary analysis of one of the coprimary endpoints did not show a statistically significant difference.
Študija formalno ni uspela, ker primarna analiza enega od so-primarnih opazovanih dogodkov ni pokazala statistično značilne razlike.
The study is associated with some methodological limitations - this was an open label study where the control group did not receive study medication which may have influenced the results.
Študija je povezana z nekaterimi metodološkimi omejitvami: šlo je za odprto študijo, v kateri kontrolna skupina ni prejemala preskušanega zdravila, kar je lahko vplivalo na rezultate.
Based on the results, there is only a 2.5% chance that the relative risk reduction for MACE exceeds 4%.
Glede na rezultate je možnost, da zmanjšanje relativnega tveganja za MACE presega 4 %, le 2,5-odstotna.
Another concern for this study was its open-label design and that the control group did not receive placebo treatment.
Drugi pomislek glede študije se je nanašal na njeno odprto zasnovo in na to, da kontrolna skupina ni prejemala zdravljenja s placebom.
In addition, less than 5% of the patients included in this study received optimal baseline therapy over the whole study period which questions the results in the context of current secondary therapy recommendations.
Poleg tega je v celotnem obdobju trajanja študije optimalno osnovno zdravljenje prejemalo manj kot 5 % bolnikov, vključenih v to študijo, zaradi česar so rezultati vprašljivi z vidika trenutnih priporočil za sekundarno zdravljenje.
In GISSI-P at the most, 5% of the patients received lipid lowering therapy over the whole period of the first year.
V študiji GISSI-P je celotno prvo leto zdravila za zniževanje ravni lipidov prejemalo največ 5 % bolnikov.
Based on these limitations, the results of the cohort studies are not considered to override the results of the randomized trials referred to above.
Glede na te omejitve so presodili, da rezultati kohortnih študij ne morejo prevladati nad rezultati randomiziranih preskušanj, navedenih zgoraj.
Furthermore, ischaemic stroke is also most often caused by atherosclerosis.
Poleg tega tudi ishemično možgansko kap najpogosteje povzroči ateroskleroza.
Grounds for re-examination have been submitted by BASF AF and ALFASIGMA S.p.A, representing eleven MAHs.
Razloge za ponovni pregled sta predložili podjetji BASF AF in ALFASIGMA S.p.A., ki zastopata enajst imetnikov dovoljenj za promet z zdravili.
The experts agreed that there is no sign of harm in the totality of data, but that the beneficial effect of omega-3s may be questioned.
Strokovnjaki so se strinjali, da v celotnih podatkih ni nobenih dokazov o škodljivosti, vendar pa je koristni učinek omega-3-maščobnih kislin lahko vprašljiv.
The efficacy in this indication was not demonstrated in subsequent and more robust clinical trials.
Učinkovitosti pri tej indikaciji v poznejših, zanesljivejših kliničnih preskušanjih niso dokazali.
Propensity score matching was incomplete or even not attempted.
Uskladitev na podlagi rezultatov nagnjenja je bila nepopolna ali je celo niso poskusili opraviti.
The MAHs citation of relevant guideline "included clinical trials need to be longterm controlled (usually 12 months or longer), parallel and preferably double-blind" is correct.
Navedba zadevnih smernic, ki so jih predložili imetniki dovoljenj za promet z zdravili, „vključena klinična preskušanja morajo biti kontrolirana dolgoročno (običajno 12 mesecev ali dlje), vzporedno in po možnosti dvojno slepo,“ je pravilna.
Beta-blockers that are indicated in most patients post MI were only used in 37 - 44% in GISSI-P.
Zaviralce beta, ki so indicirani pri večini bolnikov, ki so doživeli miokardni infarkt, je v študiji GISSI-P uporabljalo le 37-44 % bolnikov.
actually reflect biologically plausible effects or more likely reflect a selection bias problem.
Nekateri rezultati vzbujajo dvom o tem, ali opažene povezave dejansko odražajo biološko verjetne učinke ali verjetneje odražajo težavo pristranskosti pri izbiri.
The original approval of Omacor (EU reference medicinal product) was based on an open-label study (GISSI-P) from 1999.
Prvotna odobritev zdravila Omacor (referenčno zdravilo v EU) je temeljila na odprti študiji (GISSI-P) iz leta 1999.
Regarding the OMEGA study, the CHMP considered that although the trial could be considered to be underpowered this does not invalidate the study results entirely, in line with SAG on 19 March 2019.
Glede študije OMEGA je odbor CHMP menil, da je sicer preskušanje mogoče šteti za prešibko, vendar to rezultatov študije ne razveljavi v celoti, kar je v skladu s stališči znanstveno-svetovalne skupine z dne 19. marca 2019.
• The OMEGA trial (performed in 2010 after the original approval of the secondary prevention indication) was a well performed, double blind trial evaluating a population well representative of the currently approved secondary prevention indication, including the use of standard of care treatment.
• Preskušanje OMEGA (ki so ga izvedli leta 2010 po prvotni odobritvi indikacije sekundarne preventive) je bilo dobro izvedeno, dvojno slepo preskušanje, v katerem so ocenjevali populacijo, ki je bila zelo reprezentativna za trenutno odobreno indikacijo sekundarne preventive, vključno z uporabo standardnega zdravljenja.
In addition, in other prospective randomised trials performed after the original approval (GISSI-HF, ORIGIN study and SU.FOL.OM3 performed between 2003 and 2012), as well as in meta-analyses (e.g. by Aung et al. 20184), the results from the GISSI-P study could also not be reproduced.
Poleg tega tudi v drugih prospektivnih randomiziranih preskušanjih, ki so jih izvedli po prvotni odobritvi (GISSI-HF, študija ORIGIN in SU.FOL.OM3, ki so jih izvedli med letoma 2003 in 2012), in metaanalizah (npr. tisti, ki so jo izvedli Aung idr., 20184) rezultatov iz študije GISSI-P niso mogli ponoviti.
This study suffers from some methodological limitations and results should be interpreted with caution.
Študija je imela nekatere metodološke omejitve, zato je pri razlagi rezultatov potrebna previdnost.
Vitamin E is not considered beneficial in the prophylaxis of cardiovascular events.
Vitamin E ne velja za koristnega pri profilaksi srčno-žilnih dogodkov.
However, although the retrospective cohort studies seem to confirm the results of the GISSI-P study, they should be interpreted with caution given the known limitations of retrospective cohort studies.
Toda čeprav se zdi, da retrospektivne kohortne študije potrjujejo rezultate študije GISSI-P, jih je treba zaradi znanih omejitev retrospektivnih kohortnih študij razlagati previdno.
It is considered that the study had co-primary endpoints and hierarchical primary and secondary endpoint analyses.
Šteje se, da je imela študija so-primarne opazovane dogodke ter hierarhične analize primarnega in sekundarnega opazovanega dogodka.
However, ignoring double blind by using no treatment as comparator (as in GISSI-P) ignores another important concept in clinical trials, i.e. the use of a (blinded) comparator in order to control the other effects than the investigational drug, and deviation of this principle should only be needed or suitable "when it is difficult or impossible to avoid" (ICH E10 guideline on Choice of control group in clinical trials).
Vendar pa neupoštevanje načela dvojno slepe zasnove z uporabo nezdravljenja kot primerjalnega načina zdravljenja (kot v preskušanju GISSI-P) ne upošteva drugega pomembnega koncepta pri kliničnih preskušanjih, tj. uporabe (slepega) primerjalnega zdravila za kontrolo drugih učinkov, kot jih ima preskušano zdravilo, odstopanje od tega načina pa bi moralo biti potrebno ali primerno le, „kadar se mu je težko ali nemogoče izogniti“ (smernice ICH E10 o izbiri kontrolne skupine pri kliničnih preskušanjih).
Similar to OMEGA trial, a lack of effect of in this indication was observed.
Podobno kot v preskušanju OMEGA so tudi pri tej indikaciji opazili pomanjkljiv učinek.
Studies in patients with an implantable cardioverter defibrillator (ICD) showed inconsistent results regarding antiarrhythmic efficacy (Leaf et al.8, 2005; Brouwer et al.9 2006, Raitt et al.10, 2005; Weisman et al.11, 2017).
Študije pri bolnikih z vsadnim kardioverterdefibrilatorjem so pokazale neskladne rezultate v zvezi z antiaritmično učinkovitostjo (Leaf idr.8, 2005; Brouwer idr.9, 2006, Raitt idr.10, 2005; Weisman idr.11, 2017).
In GISSI-P, a reduction of sudden death events was seen in secondary two-way analyses of fatal events.
V študiji GISSI-P so pri sekundarnih dvosmernih analizah dogodkov s smrtnim izidom opazili zmanjšanje dogodkov nenadne smrti.
These limitations include the open-label study design with no study medication in the control arm, the small magnitude of effect, the unusual and unexpected observation of an effect on fatal cardiovascular events only in the absence of any effect on non-fatal events and poor precision of the results.
Med temi omejitvami so odprta zasnova študije brez preskušanega zdravila v kontrolni skupini, majhen učinek, nenavadno in nepričakovano opažanje učinka le na srčno-žilne dogodke s smrtnim izidom v odsotnosti kakršnega koli učinka na dogodke brez smrtnega izida in nenatančnost rezultatov.
All these studies carry the risk of a selection bias, which is supported by baseline data provided, e.g. in the retrospective cohort study by Polle (2013)7 only 1 % of post MI patients who were screened were included in the analysis.
Pri vseh teh študijah obstaja tveganje za pristranskost pri izbiri, kar podpirajo predloženi izhodiščni podatki; na primer v retrospektivni kohortni študiji, ki jo je izvedel Polle (2013)7, so v analizo vključili le 1 %
OMEGA trial was based on a more robust and adequate design than GISSI-P.
Preskušanje OMEGA je temeljilo na trdnejši in ustreznejši zasnovi kot preskušanje GISSIP.