FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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;
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • The PRAC concluded that hydroxyethyl starch containing products should be contraindicated in patients with sepsis, in critically ill and burn patients.
Slovenian: • odbor PRAC je zaključil, da bi morala biti zdravila, ki vsebujejo hidroksietil škrob, kontraindicirana pri bolnikih s sepso, kritično bolnih in bolnikih z opeklinami.
English: HES solutions have been the object of two reviews.
Slovenian: Raztopine, ki vsebujejo HES, so bile predmet dveh pregledov.
English: 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.
Slovenian: To pomeni, da so zaključki na podlagi člena 107i odraz najpopolnejše in najsodobnejše ocene razpoložljivih podatkov o zdravilih, ki vsebujejo hidroksietil škrob.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili ter podrobna obrazložitev odstopanj od priporočila odbora PRAC
English: • 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.
Slovenian: • 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;
English: 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.
Slovenian: 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.
English: 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:
Slovenian: 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:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Zato so zaključki na podlagi člena 107i Direktive 2001/83/ES odraz najpopolnejše in najsodobnejše ocene razpoložljivih podatkov o zdravilih, ki vsebujejo hidroksietil škrob.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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;
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Poglavje o odmerjanju mora vsebovati podatek o največjem dnevnem odmerku in priporočilo o uporabi najmanjšega učinkovitega odmerka.
English: However, it was noted that short-term haemodynamic improvements have been observed in other patient populations, including surgical and trauma patients.
Slovenian: Po drugi strani je upošteval, da so pri drugih skupinah bolnikov, vključno s kirurškimi bolniki in bolniki s poškodbami, opazili kratkotrajno izboljšanje hemodinamskih kazalcev.
English: If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Halimatoz.
Slovenian: Če imate kakršna koli vprašanja, se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro, ki so seznanjeni z zdravilom Halimatoz.
English: • If you are over 65 years you may be more susceptible to infections while taking Halimatoz.
Slovenian: • Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Halimatoz.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Halimatoz.
Slovenian: Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom Halimatoz.
English: Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Halimatoz.
Slovenian: 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.
English: If you accidentally inject Halimatoz more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required.
Slovenian: 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.
English: Side effects may occur up to 4 months or more after the last Halimatoz injection.
Slovenian: Neželeni učinki se lahko pojavijo do 4 mesece ali več po zadnji injekciji zdravila Halimatoz.
English: • On rare occasions, treatment with Halimatoz could result in lupus-like syndrome.
Slovenian: • V redkih primerih zdravljenje z zdravilom Halimatoz povzroči lupusu podoben sindrom.
English: • If you receive Halimatoz during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: • Če prejmete zdravilo Halimatoz med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček dobil okužbo.
English: • 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.
Slovenian: • 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.
English: Halimatoz in combination with methotrexate, is indicated for:
Slovenian: Zdravilo Halimatoz je v kombinaciji z metotreksatom indicirano za:
English: Treatment with Halimatoz can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Slovenian: Zdravljenje z zdravilom Halimatoz se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
English: • 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.
Slovenian: • 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.
English: • 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.
Slovenian: • 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.
English: Halimatoz can also be given alone.
Slovenian: Zdravilo Halimatoz se lahko daje tudi samo.
English: By attaching to TNFα, Halimatoz blocks its action and reduces the inflammation in these diseases.
Slovenian: Z vezavo na TNFα zdravilo Halimatoz zavre njegovo delovanje in zmanjša vnetni proces pri teh boleznih.
English: In all situations described below, the benefit / risk balance of therapy should be very carefully considered.
Slovenian: V vseh spodaj opisanih okoliščinah je treba korist in tveganje zdravljenja z zdravilom Halimatoz zelo natančno pretehtati.
English: You should not take Halimatoz with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Slovenian: Zdravila Halimatoz ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept zaradi povečanega tveganja za resne okužbe.
English: Before initiation of therapy with Halimatoz, all patients must be evaluated for both active and inactive (“latent”) tuberculosis infection.
Slovenian: Pred začetkom zdravljenja z zdravilom Halimatoz je vse bolnike treba pregledati glede aktivne in neaktivne (latentne) tuberkulozne okužbe.
English: Contents of the pack and other information What Halimatoz contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Halimatoz
English: If you forget to give yourself an injection, you should inject the next dose of Halimatoz as soon as you remember.
Slovenian: Če si pozabite dati injekcijo, si morate naslednji odmerek zdravila Halimatoz injicirati, čim se spomnite.
English: Patients on Halimatoz may receive concurrent vaccinations, except for live vaccines.
Slovenian: Bolniki, ki prejemajo zdravilo Halimatoz, lahko sočasno dobijo cepiva, razen živih cepiv.
English: The potential risk with the combination of azathioprine or 6mercaptopurine and Halimatoz should be carefully considered.
Slovenian: Potrebno je upoštevati potencialno tveganje pri sočasni uporabi azatioprina ali 6-merkaptopurina in zdravila Halimatoz.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Halimatoz.
Slovenian: Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Halimatoz.
English: Your doctor may recommend temporarily stopping Halimatoz.
Slovenian: Vaš zdravnik bo morda priporočil začasno prekinitev uporabe zdravila Halimatoz.
English: If you receive Halimatoz while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Slovenian: Halimatoz med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
English: If active tuberculosis is diagnosed, Halimatoz therapy must not be initiated (see section 4.3).
Slovenian: Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Halimatoz ne sme začeti (glejte poglavje 4.3).
English: Treatment with Halimatoz should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Slovenian: Zdravljenja z zdravilom Halimatoz se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Halimatoz in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Slovenian: O uporabi protituberkuloznega profilaktičnega zdravljenja morate pred uvedbo zdravila Halimatoz razmisliti tudi pri bolnikih s hudimi ali pomembnimi faktorji tveganja za tuberkulozo kljub negativnemu testu za tuberkulozo in pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
English: • If you are about to have surgery or dental procedures tell your doctor that you are taking Halimatoz.
Slovenian: • Če boste imeli kirurški poseg ali poseg na zobeh, povejte svojemu zdravniku, da jemljete zdravilo Halimatoz.
English: Keep Halimatoz and all medicines out of the reach of children.
Slovenian: Zdravilo Halimatoz in vsa zdravila shranjujte nedosegljivo otrokom.
English: Halimatoz treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Halimatoz is indicated.
Slovenian: Zdravljenje z zdravilom Halimatoz mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Halimatoz indicirano.
English: • Halimatoz should only be used during a pregnancy if needed.
Slovenian: • Zdravilo Halimatoz se med nosečnostjo lahko uporablja samo, če je potrebno.
English: In patients who develop HBV reactivation, Halimatoz should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Slovenian: Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila Halimatoz prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
English: Other medicines and Halimatoz
Slovenian: Druga zdravila in zdravilo Halimatoz
English: It is important that you tell your baby's doctors and other health care professionals about your Halimatoz use during your pregnancy so they can decide when your baby should receive any vaccine.
Slovenian: Zato je pomembno, da obvestite zdravnika vašega otroka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Halimatoz, da se lahko odločijo, kdaj bo vaš otrok lahko prejel katerokoli cepivo.
English: What Halimatoz is and what it is used for
Slovenian: Kaj je zdravilo Halimatoz in za kaj ga uporabljamo
English: Detailed instructions on how to inject Halimatoz are provided in section 7, “Instructions for use”.
Slovenian: Podrobna navodila za injiciranje zdravila Halimatoz so navedena v poglavju 7, ''Navodila za uporabo''.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Halimatoz, and in accordance with local recommendations.
Slovenian: Če ugotovite latentno tuberkulozo, morate pred uvedbo zdravila Halimatoz začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
English: If you take Halimatoz the risk of getting lymphoma, leukaemia, or other cancers may increase.
Slovenian: Če uporabljate zdravilo Halimatoz, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.