FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or pharmacist before taking Nityr.
Slovenian: Pred začetkom jemanja zdravila Nityr se posvetujte z zdravnikom ali farmacevtom, - če ste opazili, da imate rdeče oči ali katere koli druge znake učinka na oči.
English: NAME OF THE MEDICINAL PRODUCT Nityr 10 mg tablets
Slovenian: Nityr 10 mg tablete
English: What Nityr contains - The active substance is nitisinone.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Nityr Učinkovina je nitizinon.
English: 1 year 2 years
Slovenian: 2 letih
English: What you need to know before you take Nityr 3.
Slovenian: Kaj je zdravilo Nityr in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Nityr Kako jemati zdravilo Nityr Možni neželeni učinki
English: Lactose monohydrate
Slovenian: Glicerol dibehenat Laktoza (v obliki monohidrata)
English: The new measures are:
Slovenian: Novi ukrepi so naslednji:
English: 17 July 2018 EMA/498908/2018
Slovenian: 17. julij 2018 EMA/498908/2018
English: In the European Union, HES solutions for infusion have been approved via national procedures and are available in the Member States under various trade names.
Slovenian: V Evropski uniji so bile raztopine HES za infundiranje odobrene prek nacionalnih postopkov in so v državah članicah na voljo pod različnimi trgovskimi imeni.
English: • Alternative therapeutic options are available for routine clinical practice and should be considered according to relevant clinical guidelines.
Slovenian: • Alternativne možnosti zdravljenja so na voljo za rutinsko klinično prakso in jih je treba obravnavati v skladu z ustreznimi kliničnimi smernicami.
English: The review of HES solutions for infusion was initiated on 17 October 2017 at the request of the Swedish Medical Products Agency, under Article 107i of Directive 2001/83/EC.
Slovenian: Pregled raztopin HES za infundiranje se je začel 17. oktobra 2017 na zahtevo švedske agencije za zdravila, v skladu s členom 107i Direktive 2001/83/ES
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Slovenian: Skupina CMDh, organ, ki zastopa države članice EU, je odgovorna za zagotavljanje usklajenih varnostnih standardov za zdravila, odobrena po nacionalnih postopkih po vsej EU.
English: This programme will be implemented by the companies holding the marketing authorisations.
Slovenian: Omenjeni program bodo izvajale družbe, ki imajo dovoljenja za promet.
English: • Patients who have questions or concerns should speak to their treating doctor.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z lečečim zdravnikom.
English: • If you are given a HES infusion, your doctor will monitor your kidneys to check that they are working well enough.
Slovenian: • Če boste prejeli infuzijo HES, bo zdravnik spremljal vaše ledvice, da preveri, ali dovolj dobro delujejo.
English: • The expected benefit of treatment should be carefully weighed against the uncertainties with regard to long-term safety.
Slovenian: • Skrbno je treba pretehtati pričakovane koristi zdravljenja glede na negotovosti v zvezi z dolgoročno varnostjo.
English: Besides blood products, there are two types of medicines used for plasma volume replacement: crystalloids and colloids.
Slovenian: Poleg krvnih proizvodov obstajata dve vrsti zdravil, ki se uporabljata za nadomeščanje volumna plazme: kristaloidi in koloidi.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission.
Slovenian: Ker je skupina CMDh svoje stališče sprejela z večino glasov, je bilo to poslano Evropski komisiji.
English: They belong to the class of medicines known as colloids.
Slovenian: Sodijo v razred zdravil, znanih kot koloidi.
English: • Additional studies are ongoing with HES solutions in patients with trauma and those undergoing elective surgery to further investigate the long-term safety of HES prescribed according to the recommendations for use (dose less than 30 ml/kg and duration less than 24 hours).
Slovenian: • Izvajajo se dodatne študije o raztopinah HES pri bolnikih s travmo in tistih v postopku načrtovanih kirurških posegov, da se nadalje prouči dolgoročna varnost HES, predpisanih v skladu s priporočili za uporabo (odmerek je manj kot 30 ml/kg in čas je krajši od 24 ur).
English: Medicines to remain on the market provided that training, controlled access and warnings on the packaging are implemented
Slovenian: Zdravila ostajajo na trgu pod pogojem, da se izvajajo usposabljanja, nadzorovan dostop in opozorila na ovojnini
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), EMA's Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations on 12 January 2018.
Slovenian: Pregled je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) agencije EMA, odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, in 12. januarja 2018 podal sklop priporočil.
English: Healthcare professionals will be informed in writing of the outcome of the review and the introduction of the new risk minimisation measures, which include the introduction of a controlled access programme requiring training of relevant healthcare professionals on the safe use of these medicines.
Slovenian: Zdravstveni delavci bodo pisno obveščeni o rezultatih pregleda in uvedbi novih ukrepov za zmanjšanje tveganja, vključno z uvedbo programa nadzorovanega dostopa, ki od ustreznih zdravstvenih delavcev zahteva usposabljanje o varni uporabi teh zdravil.
English: The CMDh agreed with the PRAC's assessment of the serious risks in critically ill patients and patients with sepsis.
Slovenian: Skupina CMDh se je strinjala z oceno odbora PRAC o resnih tveganjih pri kritično bolnih bolnikih in bolnikih s sepso.
English: Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as haemodynamic goals have been achieved.
Slovenian: Zdravljenje je treba usmerjati z neprekinjenim hemodinamičnim spremljanjem, tako da se infuzija ustavi takoj, ko so doseženi hemodinamični cilji.
English: However, the CMDh gave further consideration to the place of HES in the clinical practice of some countries, noted that previous risk minimisation measures had some effect, and considered that a combination of new risk minimisation measures would effectively ensure that HES solutions are not used in patients at risk.
Slovenian: Vendar je skupina CMDh nadalje proučila položaj HES v klinični praksi nekaterih držav in ob upoštevanju dejstva, da so bili prejšnji ukrepi za zmanjšanje tveganja učinkoviti, menila, da bi kombinacija novih ukrepov za zmanjšanje tveganja učinkovito zagotovila, da se raztopine HES ne bodo uporabljale pri bolnikih s tveganjem.
English: After looking at these specific aspects, in May 2018 the PRAC confirmed its previous recommendation for suspension and sent a revised recommendation to the CMDh.
Slovenian: Potem ko je odbor PRAC proučil te posebne vidike, je maja 2018 potrdil svoje prejšnje priporočilo za začasni umik dovoljenja za promet z zdravilom in poslal revidirano priporočilo skupini CMDh.
English: • Use of HES solutions for infusion should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 hours.
Slovenian: • Uporabo raztopin HES za infundiranje je treba omejiti na začetno fazo nadomeščanja tekočin z najdaljšim časovnim intervalom 24 ur.
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Slovenian: Kot so poročali, se povečana potreba po nadomestnem zdravljenju ledvične odpovedi kaže do 90 dni po prejemu odmerka HES.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position on 24 January 2018.
Slovenian: Priporočila odbora PRAC so bila poslana usklajevalni skupini za postopek z medsebojnim priznavanjem in za decentralizirani postopek - v humani medicini (CMDh), ki je sprejela stališče 24. januarja 2018.
English: • writing directly to healthcare professionals to ensure that they are fully aware of the conditions of use of the medicines and the groups of patients that must not receive them due to an increased risk of kidney injury and death.
Slovenian: • neposredno pisno obveščanje zdravstvenih delavcev, s čimer se zagotovi, da so ti v celoti seznanjeni s pogoji uporabe zdravil in skupinami bolnikov, ki teh zdravil ne smejo prejeti zaradi povečanega tveganja okvare ledvic in smrti.
English: • the implementation of a controlled access programme by the companies holding the marketing authorisations to ensure that only accredited hospitals will be supplied with these medicines.
Slovenian: • izvajanje programa nadzorovanega dostopa s strani podjetij, ki imajo dovoljenja za promet, s čimer se zagotovi, da bodo zdravila prejele le odobrene bolnišnice.
English: The CMDh also requested marketing authorisation holders to conduct studies to check that only patients who should be treated with these medicines are receiving them.
Slovenian: Skupina CMDh je od imetnikov dovoljenja za promet zahtevala tudi izvedbo študij, s katerimi se prepričajo, da zdravila prejemajo samo bolniki, ki se morajo zdraviti z njimi.
English: This followed further reflection, in consultation with EU Member States, on whether it would be feasible to introduce new measures that would effectively reduce the risks with these medicines.
Slovenian: Do te odločitve so prišli po podrobni proučitvi in po posvetovanju z državami članicami EU, ali bi bilo mogoče uvesti nove ukrepe, s katerimi bi učinkovito zmanjšali tveganja, povezana s temi zdravili.
English: • HES solutions for infusion are also contraindicated in dehydrated patients, hyperhydrated patients, patients with intracranial or cerebral haemorrhage, burn injuries, severe hyperkalaemia, hypernatraemia, hyperchloraemia, congestive heart failure, organ transplant patients and patients with impaired hepatic function.
Slovenian: • Raztopine HES za infundiranje so prav tako kontraindicirane pri dehidriranih bolnikih, hiperhidriranih bolnikih, bolnikih z znotrajlobanjsko ali možgansko krvavitvijo, opeklinami, hudo hiperkaliemijo, hipernatriemijo, hiperkloremijo ali srčnim popuščanjem, bolnikih s presajenim organom in bolnikih z oslabljenim delovanjem jeter.
English: This is in addition to ongoing studies on the benefits and risks of HES solutions in patients with trauma and those undergoing elective surgery.
Slovenian: Te se izvajajo poleg tekočih študij o koristih in tveganjih raztopin HES pri bolnikih s travmo in tistih v postopku nenujnih operacij.
English: Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients
Slovenian: Raztopine hidroksietilnega škroba: skupina CMDh uvaja nove ukrepe za zaščito bolnikov
English: Blood coagulation parameters should be monitored carefully in case of prolonged use.
Slovenian: V primeru podaljšane uporabe je treba skrbno spremljati parametre koagulacije krvi.
English: The accreditation would require that relevant healthcare professionals receive training on the safe use of HES solutions for infusion.
Slovenian: Za pridobitev odobritve bi morali ustrezni zdravstveni delavci opraviti usposabljanje o varni uporabi raztopin HES za infundiranje.
English: In April 2018, the European Commission requested that the PRAC and the CMDh further consider any possible unmet medical need that could result from a suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures.
Slovenian: Evropska komisija je aprila 2018 zahtevala, da odbor PRAC in skupina CMDh nadalje proučita morebitne neizpolnjene zdravstvene potrebe, ki bi lahko izhajale iz začasnega umika dovoljenja za promet z zdravilom, ter izvedljivost in verjetno učinkovitost dodatnih ukrepov za zmanjšanje tveganj.
English: In January 2018, EMA's safety committee PRAC recommended suspending the marketing authorisations of these medicines because they continued to be used in critically ill patients and patients with sepsis despite restrictions introduced in 2013 due to the risk of kidney injury and death in these patients.
Slovenian: Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila je januarja 2018 sprejel priporočilo o začasnem preklicu dovoljenj za promet s temi zdravili, saj so se ta še naprej uporabljala pri kritično bolnih bolnikih in bolnikih s sepso kljub omejitvam, uvedenim leta 2013, zaradi tveganja okvare ledvic in smrti pri teh bolnikih.
English: • HES solutions for infusion are used to replace fluids in the body after acute (sudden) blood loss.
Slovenian: • Raztopine HES za infundiranje se uporabljajo za nadomeščanje tekočin v telesu po akutni (nenadni) izgubi krvi.
English: They are given by infusion (drip) into a vein and are used as blood volume expanders to prevent a dangerous drop in blood pressure following acute bleeding.
Slovenian: Dajejo se z infuzijo (kapalno) v veno in se uporabljajo kot sredstva za povečanje krvnega volumna, da se prepreči nevarno znižanje krvnega tlaka po akutni krvavitvi.
English: Colloids contain large molecules such as starch, whereas crystalloids, such as saline or Ringer's solutions, are electrolyte solutions.
Slovenian: Koloidi vsebujejo velike molekule, kot je škrob, kristaloidi, kot je fiziološka ali Ringerjeva raztopina, pa so raztopine elektrolitov.
English: Further details about the training and the controlled access programme will be provided to hospitals and healthcare professionals in due time;
Slovenian: Nadaljnje podrobnosti o usposabljanju in programu nadzorovanega dostopa bodo bolnišnicam in zdravstvenim delavcem pravočasno na voljo;
English: Further details about the training and the controlled access programme will be provided to hospitals and healthcare professionals in due time.
Slovenian: Nadaljnje podrobnosti o usposabljanju in programu nadzorovanega dostopa bodo bolnišnicam in zdravstvenim delavcem pravočasno na voljo.
English: • HES solutions for infusion are contraindicated in severe coagulopathy.
Slovenian: • Raztopine HES za infundiranje so kontraindicirane pri hudi koagulopatiji.
English: The CMDh position was adopted by majority vote and the matter was sent to the European Commission, which took an EU-wide legally binding decision on 17 July 2018.
Slovenian: Skupina CMDh je svoje stališče sprejela z večino glasov, zadeva pa je bila nato poslana Evropski komisiji, ki je 17. julija 2018 sprejela pravno zavezujoči sklep, veljaven po vsej EU.
English: The use of HES must be discontinued at the first sign of renal injury.
Slovenian: Z uporabo HES je treba prenehati ob prvem znaku okvare ledvic.
English: • warnings in the medicines' packaging and at the top of the summaries of product characteristics (SmPCs) reminding healthcare professionals that these medicines must not be used in patients with sepsis or kidney impairment or in critically ill patients;
Slovenian: • opozorila na ovojnini zdravil in na vrhu povzetkov glavnih značilnosti zdravila, ki opozarjajo zdravstvene delavce, da se ta zdravila ne smejo uporabljati pri bolnikih s sepso ali okvaro ledvic ali pri kritično bolnih bolnikih;
English: On 27 June 2018, the CMDh1 decided that hydroxyethyl starch (HES) solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented.
Slovenian: Skupina CMDh1 se je 27. junija 2018 odločila, da raztopine hidroksietil škroba (HES) za infundiranje ostanejo na trgu pod pogojem, da se izvede kombinacija dodatnih ukrepov za zaščito bolnikov.
English: In June 2018, the CMDh concluded that HES solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented.
Slovenian: Junija 2018 je skupina CMDh sklenila, da bi morale raztopine HES za infundiranje ostati na trgu pod pogojem, da se izvede kombinacija dodatnih ukrepov za zaščito bolnikov.
English: As the CMDh position was adopted by majority vote, the CMDh position was sent back to the European Commission, which took an EU-wide legally binding decision on 17 July 2018.
Slovenian: Ker je skupina CMDh svoje stališče sprejela z večino glasov, so ga poslali nazaj Evropski komisiji, ki je 17. julija 2018 izdala pravno zavezujoči sklep, veljaven po vsej EU.
English: HES solutions should be discontinued at the first sign of coagulopathy.
Slovenian: Uporabo raztopin HES je treba opustiti ob prvem znaku koagulopatije.
English: HES solutions for infusion are used to replace plasma volume following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids' alone is not considered sufficient.
Slovenian: Raztopine HES za infundiranje se uporabljajo za nadomeščanje volumna plazme po akutni (nenadni) izgubi krvi, kjer zdravljenje z alternativnimi izdelki, znanimi kot „kristaloidi“, ni zadostno.
English: • HES solutions for infusion should be used for managing hypovolaemia due to acute blood loss only when crystalloids alone are not considered sufficient.
Slovenian: • Raztopine HES za infundiranje se uporabljajo pri nadzorovanju hipovolemije zaradi akutne izgube krvi, le če kristaloidi sami ne zadostujejo.
English: • HES solutions for infusion are contraindicated in patients with renal impairment or undergoing renal replacement therapy.
Slovenian: • Raztopine HES za infundiranje so kontraindicirane pri bolnikih z okvaro ledvic ali med nadomestnim zdravljenjem ledvične odpovedi.
English: HES solutions should not be used for fluid maintenance.
Slovenian: Raztopine HES se ne smejo uporabljati za nadzorovanje tekočine.
English: • Because of the risk of kidney injury and death, HES solutions for infusion must not be used in patients with blood infection or kidneys problems or in critically ill patients.
Slovenian: • Zaradi nevarnosti okvare ledvic in smrti se raztopine HES za infundiranje ne smejo uporabljati pri bolnikih s krvnimi okužbami ali težavami z ledvicami ali pri kritično bolnih bolnikih.
English: • Because of the risk of kidney injury and mortality, HES solutions for infusion are contraindicated in patients with sepsis or in critically ill patients.
Slovenian: • Zaradi tveganja okvare ledvic in smrtnosti so raztopine HES za infundiranje kontraindicirane pri bolnikih s sepso ali kritično bolnih bolnikih.
English: HES solutions for infusion are used for the management of hypovolaemia (low blood volume) caused by acute blood loss, where treatment with alternative infusion solutions known as ‘crystalloids' alone is not considered sufficient.
Slovenian: Raztopine HES za infundiranje se uporabljajo za nadzorovanje hipovolemije (majhne količine krvi) zaradi akutne izgube krvi, kadar zdravljenje z alternativnimi raztopinami za infundiranje, znanimi kot „kristaloidi“, ne zadošča.
English: Patients' kidney function should be monitored after HES administration.
Slovenian: Po uporabi HES je treba spremljati delovanje bolnikovih ledvic.
English: 1 kit containing: 1 vial of ibritumomab tiuxetan, 1 vial of sodium acetate solution, 1 vial of formulation buffer and 1 empty reaction vial
Slovenian: 1 komplet vsebuje: 1 vialo z ibritumomab tiuksetanom, 1 vialo z raztopino natrijevega acetata, 1 vialo s pufrom za pripravo formulacije in eno prazno vialo za pripravo zmesi
English: 1.6 mg/ml Kit for radiopharmaceutica l preparation for infusion
Slovenian: 1,6 mg/ml Komplet za pripravo radiofarmaka za infuzijo
English: 2 ml
Slovenian: Viala (steklena) 2 ml
English: Intravenous use Vial (glass)
Slovenian: Intravenska uporaba
English: EU number
Slovenian: Številka EU Zaščiteno ime Jakost
English: Date of first authorisation: 12 November 2012 Date of latest renewal: 28 August 2017
Slovenian: Datum prve odobritve: 12. november 2012 Datum zadnjega podaljšanja: 28. avgust 2017
English: More information is given below under ‘Other medicines and Forxiga'.
Slovenian: Več informacij je na voljo v nadaljevanju v poglavju "Druga zdravila in zdravilo Forxiga".
English: Forxiga is used in adult patients (aged 18 years and older).
Slovenian: Zdravilo Forxiga se uporablja pri odraslih bolnikih (starih 18 let ali več).
English: Other medicines and Forxiga Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Forxiga Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: If you are taking Forxiga for type 1 diabetes, it is important that you keep using insulin.
Slovenian: Če zdravilo Forxiga jemljete za zdravljenje sladkorne bolezni tipa 1, je pomembno, da še naprej uporabljate insulin.
English: If you are taking Forxiga for type 1 diabetes: • The recommended dose is one 5 mg tablet each day.
Slovenian: Če jemljete zdravilo Forxiga za sladkorno bolezen tipa 1: Priporočeni odmerek je ena 5-mg tableta vsak dan.
English: If Fournier's gangrene is suspected, Forxiga should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Slovenian: Če obstaja sum na Fournierjevo gangreno, je treba zdravilo Forxiga ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
English: • When you are treated with Forxiga, diabetic ketoacidosis can occur even if your blood sugar is normal.
Slovenian: • če jemljete zdravilo Forxiga, se lahko diabetična ketoacidoza pojavi, tudi če imate normalen krvni sladkor.
English: • Forxiga is used together with insulin.
Slovenian: • Zdravilo Forxiga se uporablja skupaj z insulinom.
English: glimepiride 4 mg/day;
Slovenian: Glimepirid 4 mg/dan;
English: Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
Slovenian: Previdnost je potrebna pri bolnikih, pri katerih bi z dapagliflozinom povzročen padec krvnega tlaka lahko pomenil tveganje, npr. pri bolnikih, ki se zdravijo z antihipertenzivi in imajo hipotenzijo v anamnezi ali pri starejših bolnikih.
English: Type 1 diabetes mellitus Treatment with Forxiga is to be initiated and supervised by specialists in type 1 diabetes.
Slovenian: Sladkorna bolezen tipa 1 Zdravljenje z zdravilom Forxiga morajo uvesti in nadzorovati specialisti za sladkorno bolezen tipa 1.
English: Forxiga has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease (ESRD).
Slovenian: Zdravilo Forxiga ni bilo raziskano pri hudi okvari ledvic (GFR < 30 ml/min) ali pri končni odpovedi ledvic (ESRD - end-stage renal disease).
English: Forxiga should only be used in type 1 diabetes patients who are overweight or obese.
Slovenian: Zdravilo Forxiga se sme uporabljati le pri bolnikih s sladkorno boleznijo tipa 1, ki so pretežki ali debeli.
English: Forxiga has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Forxiga nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: In active- and placebo-controlled clinical studies (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
Slovenian: V kliničnih študijah, kontroliranih z učinkovino in s placebom (dapagliflozin; n = 5936, vse kontrolne osebe; n = 3403) je bila pogostnost izpuščaja z dapagliflozinom (1,4 %) podobna kot pri vseh kontrolnih osebah (1,4 %).
English: Driving and using machines Forxiga has no or negligible influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Forxiga nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: • Forxiga is used if your type 1 diabetes cannot be controlled with insulin alone.
Slovenian: • Zdravilo Forxiga se uporablja, če sladkorne bolezni tipa 1 ni mogoče urediti samo z insulinom.