natgillin/translations-raw huggingface dataset:
To this end the MAHs were strongly advised to seek scientific advice with the European Medicines Agency, in time for the submission of the study protocols to the national competent authorities (NCAs) within 6 months of the European Commission Decision.
V ta namen so imetnikom dovoljenj za promet z zdravili izrecno svetovali, naj pridobijo znanstveno mnenje Evropske agencije za zdravila, preden se izteče rok za predložitev protokolov študij pristojnim nacionalnim organom, ki je 6 mesecev od sklepa Evropske komisije.
The PRAC also considered that studies should be conducted to provide more evidence on the efficacy and safety of hydroxyethyl starch in the perioperative setting and trauma.
Prav tako je menil, da so potrebne študije za zagotovitev dodatnih dokazov o učinkovitosti in varnosti hidroksietil škroba v perioperativnem okolju in pri poškodbah.
Therefore, the PRAC agreed that the therapeutic indication of hydroxyethyl starch containing products should be restricted to treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Odbor PRAC je zato sklenil, da bi bilo treba terapevtsko indikacijo zdravil, ki vsebujejo hidroksietil škrob, omejiti na zdravljenje hipovolemije zaradi akutne izgube krvi, kadar sami kristaloidi ne zadoščajo.
Whilst recognising the limitations of these studies which included limited size and short duration of follow-up, the PRAC noted that some volume sparing effect was reported in Madi-Jebara et al. 2008, that suggested that HES 130/0.4 6% seems to have benefits over twice the volume of Ringer's lactate in preventing spinal anaesthesia induced hypotension.
Čeprav je odbor PRAC ugotovil, da so imele omenjene študije določene omejitve, na primer omejen obseg in kratko trajanje spremljanja, je upošteval, da so v študiji, ki so jo objavili Madi-Jebara et al. (2008), opazili določen učinek na ohranitev volumna, ki kaže, da ima 6-odstotni HES 130/0,4 večje koristi od dvakrat večje količine Ringerjevega laktata pri preprečevanju hipotenzije po spinalni anesteziji.
Following requests for re-examination by marketing authorisation holders (MAHs), the PRAC confirmed its previous position under the Article 31 in October 2013.
Potem ko so imetniki dovoljenj za promet z zdravili zahtevali ponoven pregled mnenja, je odbor PRAC oktobra 2013 potrdil svoje prvotno mnenje na podlagi člena 31.
On the basis of the available data, in particular results from VISEP, 6S and CHEST studies, the PRAC concluded that HES is associated with an increased risk of mortality and renal failure in patients with sepsis, in critically ill and burn patients and that the benefits of HES do not outweigh the risks in these patient populations.
Na podlagi razpoložljivih podatkov, zlasti rezultatov iz študij VISEP, 6S in CHEST, je odbor PRAC zaključil, da je HES povezan s povečanim tveganjem za smrtnost in odpoved ledvic pri bolnikih s sepso, kritično bolnih ter bolnikih z opeklinami in da koristi HES ne odtehtajo več tveganj pri teh skupinah bolnikov.
The PRAC therefore acknowledged the results of this studies which shows no risk of mortality associated with the use of HES but considered that given the limitations of this study its findings could not negate the findings from 6S and VISEP studies that had shown an increased risk of mortality in critically ill patients.
Odbor PRAC je upošteval rezultate te študije, ki so pokazali, da uporaba HES ni povezana s povečanim tveganjem za smrtnost, vendar je menil, da zaradi omejitev omenjene študije njeni rezultati ne morejo ovreči ugotovitev iz študij 6S in VISEP, ki so pokazale povečano tveganje za smrtnost pri kritično bolnih.
Although the mechanisms by which increased renal injury and mortality occur is not well established, it is possible that the degree of inflammatory processes seen in sepsis and critically ill patients is greater and associated with significant capillary leakage compared with other patient populations such as the perioperative setting after elective surgery or un-complicated trauma where the systematic inflammatory process and the extent of capillary leak may be lower.
Čeprav mehanizmi, zaradi katerih se povečajo okvare jeter in smrtnost, niso povsem raziskani, obstaja možnost, da je stopnja vnetnih procesov pri septičnih in kritično bolnih bolnikih višja in povezana z večjim prepuščanjem kapilar kot pri drugih skupinah bolnikov, na primer bolnikih v perioperativnem okolju po načrtovanem kirurškem posegu ali nezapleteni poškodbi, ko sta stopnja sistemskega vnetnega procesa in obseg prepuščanja kapilar lahko manjša.
• The PRAC considered, in view of the new evidence which includes data from clinical trials, further expert advice, new proposals for additional risk minimisation measures, including restrictions on use and a commitment from the MAHs to perform additional studies in patients with trauma and in elective surgery, that the benefit of hydroxyethyl starch containing products outweighs the risk in the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
• odbor PRAC je na podlagi novih dokazov, vključno s podatki iz kliničnih študij, dodatnega izvedenskega mnenja, novih predlogov za dodatne ukrepe za zmanjšanje tveganja, ki vključujejo omejitve glede uporabe in obvezo imetnikov dovoljenj za promet z zdravili, da bodo izvedli dodatne študije na bolnikih s poškodbami in bolnikih, pri katerih je predviden kirurški poseg, menil, da so koristi zdravil, ki vsebujejo hidroksietil škrob, večje od tveganj pri zdravljenju hipovolemije zaradi akutne izgube krvi, kadar sami kristaloidi ne zadoščajo.
In addition, two phase IV randomised clinical trials with an appropriate control and clinically meaningful endpoints will need to be conducted to provide more evidence on the efficacy and safety, including the risk of 90-day mortality and renal failure, in perioperative and trauma populations.
Poleg tega je treba izvesti dve randomizirani klinični preskušanji IV. faze z ustrezno kontrolo in klinično relevantnimi opazovanimi dogodki za pridobitev dodatnih dokazov o učinkovitosti in varnosti, vključno s podatki o tveganju za smrtnost in odpoved ledvic v 90 dneh, pri bolnikih v perioperativnem obdobju in bolnikih s poškodbami.
Detailed explanation for the differences from the PRAC recommendation
Podrobna obrazložitev odstopanj od priporočila odbora PRAC
Scientific conclusions and grounds for the variation to the terms of the marketing authorisations subject to conditions and detailed explanation for the differences from the PRAC recommendation
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili pod določenimi pogoji ter podrobna obrazložitev odstopanj od priporočila odbora PRAC
However, with regards to the two phase IV randomised clinical trials (RCTs) requested to provide more evidence on the efficacy and safety in perioperative and trauma populations, including the risk of 90-day mortality and renal failure, , the CMDh encouraged the MAHs to jointly submit common study protocols.
Kar zadeva dva randomizirana klinična preskusa IV. faze (RCT), ki sta bila zahtevana za pridobitev dodatnih dokazov o učinkovitosti in varnosti pri bolnikih v perioperativnem obdobju in bolnikih s poškodbami, vključno s podatki o tveganju za smrtnost in odpoved ledvic v 90 dneh, je skupina CMDh pozvala imetnike dovoljenj za promet z zdravili, da skupaj predložijo enotna protokola študij.
• The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 107i of Directive 2001/83/EC, for hydroxyethyl starch containing products for solutions for infusion.
• Odbor za oceno tveganja na področju farmakovigilance (PRAC) je obravnaval napotitveni postopek v skladu s členom 107i Direktive 2001/83/ES za raztopine za infundiranje, ki vsebujejo hidroksietil škrob;
HES products are contraindicated in patients with renal impairment or renal replacement therapy but the contraindications should also be extended to include other patient populations including patients with sepsis, critically ill patients and burns patients.
Zdravila, ki vsebujejo HES, so kontraindicirana pri bolnikih z okvaro ledvic in bolnikih, ki potrebujejo nadomestno zdravljenje ledvične odpovedi, vendar bi bilo treba kontraindikacije razširiti tudi na druge skupine bolnikov, vključno na bolnike s sepso, kritično bolne in bolnike z opeklinami.
The MAHs should submit within 6 months of the European Commission Decision, the core elements (including protocol of DUS, protocols of the RCTs) of a risk management plan in EU format and this was included in Annex IV.
Imetniki dovoljenja za promet z zdravili morajo v 6 mesecih od sklepa Evropske komisije predložiti ključne dele (vključno s protokolom študije uporabe zdravila in protokoloma randomiziranih kliničnih preskušanj) načrta obvladovanja tveganj v formatu EU.
• The PRAC concluded that hydroxyethyl starch containing products should be contraindicated in patients with sepsis, in critically ill and burn patients.
• odbor PRAC je zaključil, da bi morala biti zdravila, ki vsebujejo hidroksietil škrob, kontraindicirana pri bolnikih s sepso, kritično bolnih in bolnikih z opeklinami.
HES solutions have been the object of two reviews.
Raztopine, ki vsebujejo HES, so bile predmet dveh pregledov.
Therefore the conclusions on the Article 107i reflect the most complete and up-to-date evaluation of the available data relating to HES containing medicinal products.
To pomeni, da so zaključki na podlagi člena 107i odraz najpopolnejše in najsodobnejše ocene razpoložljivih podatkov o zdravilih, ki vsebujejo hidroksietil škrob.
The CMDh having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC and the oral explanations by the Marketing Authorisation Holders on 21 October 2013, reached a position on the variation to the terms of the marketing authorisations of Hydroxyethyl starch solutions for infusion containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Skupina CMDh je na podlagi proučitve priporočila, ki ga je 10. oktobra 2013 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES izdal odbor PRAC, ter ustnih obrazložitev, ki so jih 21. oktobra 2013 podali imetniki dovoljenj za promet z zdravili, sprejela stališče o spremembi pogojev dovoljenj za promet z raztopinami za infundiranje, ki vsebujejo hidroksietil škrob, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III, in pod pogoji, določenimi v Prilogi IV.
Therefore, the PRAC noted the available data from studies in surgical and trauma patients and considered that although these studies were limited in size and duration of follow-up they did provide some reassurance that the risks of mortality and renal injury in surgical and trauma patients may be lower than those in the critically ill and sepsis patients.
Odbor PRAC je torej upošteval razpoložljive podatke iz študij na kirurških bolnikih in bolnikih s poškodbami ter menil, da so študije kljub omejenemu obsegu in trajanju spremljanja zagotovile nekaj dokazov o tem, da bi lahko bilo tveganje za smrtnost in okvaro ledvic pri kirurških bolnikih in bolnikih s poškodbami manjše kot pri kritično bolnih in bolnikih s sepso.
Consequently, a second review of HES solutions under Article 107i of Directive 2001/83/EC was initiated, and it ran separately but in parallel with the re-examination of the Article 31, also finalising in October 2013.
Posledično se je začel še drugi pregled raztopin, ki vsebujejo hidroksietil škrob, v skladu s členom 107i Direktive 2001/83/ES, ki je potekal ločeno, vendar vzporedno s ponovnim pregledom mnenja po členu 31, tako da sta se oba zaključila oktobra 2013.
The CMDh amended the due date for the submission of the protocol of the drug utilisation study which is now also due within 6 months of the European Commission Decision in order to harmonise submission dates of all conditions.
Da bi uskladila datume za predložitev vsega zahtevanega, je skupina CMDh spremenila rok za predložitev protokola študije uporabe zdravila, ki je sedaj prav tako 6 mesecev od sklepa Evropske komisije.
Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations and detailed explanation for the differences from the PRAC recommendation
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili ter podrobna obrazložitev odstopanj od priporočila odbora PRAC
• The PRAC considered that the use of hydroxyethyl starch is associated with an increased risk of mortality and renal replacement therapy or renal impairment in patients with sepsis, critically ill and burn patients.
• odbor PRAC je menil, da je uporaba hidroksietil škroba povezana s povečanim tveganjem za smrtnost in potrebo po nadomestnem zdravljenju odpovedi ledvic ali okvaro ledvic pri bolnikih s sepso, kritično bolnih in bolnikih z opeklinami;
In view of the totality of the evidence available in the procedure under Article 107i of Directive 2001/83/EC, the PRAC considered that Hydroxyethyl starch should be restricted to the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient subject to agreed restrictions, contraindications, warnings, other changes to the product information and additional risk minimisation measures.
Na podlagi vseh podatkov, ki so bili na voljo v postopku po členu 107i Direktive 2001/83/ES, je PRAC zaključil, da bi bilo treba uporabo hidroksietil škroba omejiti na zdravljenje hipovolemije zaradi akutne izgube krvi, kadar sami kristaloidi ne zadoščajo, ob upoštevanju dogovorjenih omejitev, kontraindikacij, opozoril, drugih sprememb informacij o zdravilu in dodatnih ukrepov za zmanjšanje tveganja.
The CMDh considered the below PRAC recommendations following the procedure under Article 107i of Directive 2001/83/EC dated 10 October 2013 with regards to Hydroxyethyl starch containing medicinal products solutions for infusion:
Skupina CMDh je proučila spodnja priporočila, ki jih je izdal odbor PRAC po postopku iz člena 107i Direktive 2001/83/ES dne 10. oktobra 2013 v zvezi z zdravili v obliki raztopin za infundiranje, ki vsebujejo hidroksietil škrob:
The PRAC concluded that the benefit-risk balance for hydroxyethyl starch containing medicinal products remains favourable in treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient subject to the agreed restrictions, contraindications, warnings, other changes to the product information and additional risk minimisation measures.
Odobr PRAC je zaključil, da je razmerje med tveganji in koristmi za zdravila, ki vsebujejo hidroksietil škrob, pri zdravljenju hipovolemije zaradi akutne izgube krvi, kadar sami kristaloidi ne zadoščajo, še vedno ugodno, če se upoštevajo dogovorjene omejitve, kontraindikacije, opozorila, druge spremembe informacij o zdravilu in dodatni ukrepi za zmanjšanje tveganja.
Therefore the conclusions on the Article 107i of Directive 2001/83/EC reflect the most complete and up-to-date evaluation of the available data relating to the HES containing medicinal products.
Zato so zaključki na podlagi člena 107i Direktive 2001/83/ES odraz najpopolnejše in najsodobnejše ocene razpoložljivih podatkov o zdravilih, ki vsebujejo hidroksietil škrob.
Under the framework of Article 107i of Directive 2001/83/EC, the PRAC considered recommendations on HES rendered in the referral under Article 31 of Directive 2001/83/EC and also reviewed available data including clinical studies, meta-analyses of clinical studies, post-marketing experience, responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, spontaneous reports on the safety and efficacy of hydroxyethyl starch containing products for solutions for infusion, as well as stakeholders' submissions in particular with regards to the risk of mortality and renal failure.
Odbor PRAC je v okviru člena 107i Direktive 2001/83/ES proučil priporočila v zvezi s HES, izdana v napotitvenem postopku v skladu s členom 31 Direktive 2001/83/ES, ter pregledal razpoložljive podatke, vključno s kliničnimi študijami, meta analizami kliničnih študij, postmarketinškimi izkušnjami, odgovori, ki so jih imetniki dovoljenj za promet z zdravili podali v obliki pisnih in ustnih obrazložitev in spontanimi poročili glede varnosti in učinkovitosti raztopin za infundiranje, ki vsebujejo hidroksietil škrob, ter tudi podatke, ki so jih predložile zainteresirane strani, zlasti v zvezi s tveganjem za smrtnost in odpoved ledvic.
This new evidence was not available when the PRAC recommendation on the procedure under Article 31 of Directive 2001/83/EC was issued in June 2013 and could therefore not be considered in the re-examination of the latter in October 2013.
Slednji junija 2013, ko je odbor PRAC izdal priporočilo v zvezi s postopkom po členu 31 Direktive 2001/83/ES, niso bili na voljo, zato jih pri ponovnem pregledu priporočila oktobra 2013 ni mogel upoštevati.
The PRAC conclusion in the context of the referral procedure under Article 107i of Directive 2001/83/EC included additional data that was not available when the PRAC issued its recommendation on the referral in accordance with Article 31 of Directive 2001/83/EC in June 2013 and therefore could not be considered in the re-examination of the latter in October 2013.
Sklep odbora PRAC v okviru napotitvenega postopka po členu 107i Direktive 2001/83/ES je temeljil tudi na dodatnih podatkih, ki niso bili na voljo, ko je junija 2013 izdal priporočilo v zvezi z napotitvenim postopkom v skladu s členom 31 Direktive 2001/83/ES, zaradi česar jih pri ponovnem pregledu priporočila oktobra 2013 ni mogel upoštevati.
However, for the current procedure under Article 107i of Directive 2001/83/EC the PRAC reviewed new available data, with a focus on risk of mortality and renal failure, including clinical studies, meta-analyses of clinical studies, post-marketing experience, responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations and stakeholders' submissions.
V tem postopku po členu 107i Direktive 2001/83/ES pa je pregledal nove razpoložljive podatke, zlasti podatke o tveganju za smrtnost in odpoved ledvic, vključno s kliničnimi študijami, meta analizami kliničnih študij, izkušnjami v obdobju trženja, odgovori, ki so jih imetniki dovoljenj za promet z zdravili podali v obliki pisnih in ustnih obrazložitev, ter podatki, ki so jih predložile zainteresirane strani;
Meybohm P et al. 2013 suggest that use of HES should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 h. Martin et al 2002 showed that HES treatment resulted in a significantly lower estimated blood loss and that there was no difference in red blood cells, or blood product utilisation among the groups.
Martin et al. (2002) so ugotovili, da je zdravljenje s HES povzročilo znatno manjšo ocenjeno izgubo krvi in da med skupinami ni bilo razlik v številu rdečih krvnih celic ali uporabi krvnih pripravkov.
HES solutions should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 h. The posology section should identify the maximum daily dose and should recommend that the lowest possible effective dose should be employed.
Poglavje o odmerjanju mora vsebovati podatek o največjem dnevnem odmerku in priporočilo o uporabi najmanjšega učinkovitega odmerka.
However, it was noted that short-term haemodynamic improvements have been observed in other patient populations, including surgical and trauma patients.
Po drugi strani je upošteval, da so pri drugih skupinah bolnikov, vključno s kirurškimi bolniki in bolniki s poškodbami, opazili kratkotrajno izboljšanje hemodinamskih kazalcev.
If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Halimatoz.
Če imate kakršna koli vprašanja, se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro, ki so seznanjeni z zdravilom Halimatoz.
• If you are over 65 years you may be more susceptible to infections while taking Halimatoz.
• Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Halimatoz.
You and your doctor should pay special attention to signs of infection while you are being treated with Halimatoz.
Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom Halimatoz.
Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Halimatoz.
To opozorilno kartico za bolnika imejte pri sebi med zdravljenjem in še štiri mesece po svoji zadnji injekciji (ali zadnji injekciji vašega otroka) zdravila Halimatoz.
If you accidentally inject Halimatoz more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required.
Če pomotoma injicirate zdravilo Halimatoz pogosteje, kot bi smeli, se morate posvetovati z zdravnikom ali s farmacevtom in mu pojasniti, da ste uporabili večji odmerek, kot ga potrebujete.
Side effects may occur up to 4 months or more after the last Halimatoz injection.
Neželeni učinki se lahko pojavijo do 4 mesece ali več po zadnji injekciji zdravila Halimatoz.
• On rare occasions, treatment with Halimatoz could result in lupus-like syndrome.
• V redkih primerih zdravljenje z zdravilom Halimatoz povzroči lupusu podoben sindrom.
• If you receive Halimatoz during your pregnancy, your baby may have a higher risk for getting an infection.
• Če prejmete zdravilo Halimatoz med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček dobil okužbo.
• Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Halimatoz in case they cause infections.
• Določena cepiva lahko vsebujejo žive, vendar oslabljene oblike bakterij ali virusov, ki povzročajo bolezen, in teh cepiv se med zdravljenjem z zdravilom Halimatoz ne sme uporabljati, da ne bi povzročila okužb.
Halimatoz in combination with methotrexate, is indicated for:
Zdravilo Halimatoz je v kombinaciji z metotreksatom indicirano za:
Treatment with Halimatoz can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Zdravljenje z zdravilom Halimatoz se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
• If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Halimatoz and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.
• Če imate alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Halimatoz ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
• As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Halimatoz.
• Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom Halimatoz preiskal glede znakov in simptomov tuberkuloze.
Halimatoz can also be given alone.
Zdravilo Halimatoz se lahko daje tudi samo.
By attaching to TNFα, Halimatoz blocks its action and reduces the inflammation in these diseases.
Z vezavo na TNFα zdravilo Halimatoz zavre njegovo delovanje in zmanjša vnetni proces pri teh boleznih.
In all situations described below, the benefit / risk balance of therapy should be very carefully considered.
V vseh spodaj opisanih okoliščinah je treba korist in tveganje zdravljenja z zdravilom Halimatoz zelo natančno pretehtati.
You should not take Halimatoz with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Zdravila Halimatoz ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept zaradi povečanega tveganja za resne okužbe.