natgillin/translations-raw huggingface dataset:
• In addition, the PRAC recommended, as provisional measures to further minimise the risk of liver injury, to strengthen the current warnings to take due account that all patients should be monitored for signs and symptoms of hepatic injury and that liver functions testing should be performed at least monthly, to promptly refer patients to an hepatologist in case of signs or symptoms suggestive of such injury and that treatment initiation is not recommended in patients with other autoimmune conditions.
• Poleg tega odbor PRAC kot začasni ukrep za nadaljnje zmanjšanje tveganja za poškodbe jeter priporoča okrepitev obstoječih opozoril tako, da bodo zahtevala, da je treba spremljati vse bolnike glede znakov in simptomov poškodbe jeter, da morajo biti preizkusi funkcije jeter izvedeni vsaj enkrat mesečno, da morajo biti vsi bolniki, ki kažejo znake ali simptome takšnih poškodb nemudoma napoteni k hepatologu, ter, da uvedba zdravljenja z daklizumabom ni priporočljiva za bolnike z avtoimunskimi obolenji.
• The PRAC recommended as provisional measure amendment to the indication of daclizumab to restrict its use to adult patients with highly active relapsing disease despite a previous treatment with at least one disease modifying therapy (DMT) or, with rapidly evolving severe relapsing multiple sclerosis who are unsuitable for treatment with other DMTs.
• Odbor PRAC kot prehodni ukrep priporoča spremembo indikacije daklizumaba tako, da se njegova uporaba omeji na odrasle bolnike z visoko aktivno recidivno multiplo sklerozo, ki je prisotna kljub predhodnemu zdravljenju z vsaj enim zdravilom, ki spreminja potek bolezni (DMT), ali na odrasle bolnike s hitro napredujočo hudo recidivno multiplo sklerozo, ki niso primerni za zdravljenje z drugimi zdravili DMT.
Notable for this fatal case was the occurrence of rapid fulminant liver failure in the setting of recommended liver function monitoring and concomitant use of another medicinal product known to be associated with hepatotoxicity.
Pomembno dejstvo pri tem smrtnem primeru je bil nastop hitre fulminantne odpovedi jeter kljub izvajanju priporočenega rednega spremljanja delovanja jeter ter ob sočasnemu jemanju drugega zdravila, ki je povezano s hepatotoksičnostjo.
The PRAC considered the preliminary new safety data from a recent fatal case of fulminant liver failure and from cases of serious liver injury that occurred since the marketing authorisation, in the context of the data generated during the clinical development of daclizumab.
Odbor PRAC je obravnaval nove predhodne podatke o varnosti na podlagi nedavnega primera fulminantne odpovedi jeter s smrtnim izidom, ter na podlagi primerov resnih poškodb jeter, ki so se zgodili po izdaji dovoljenja za promet, v kontekstu podatkov, ki so bili pridobljeni med kliničnim razvojem daklizumaba.
The majority of findings were asymptomatic transaminases elevations, however a low incidence of serious liver events and a rare incidence of fatal liver failure (autoimmune hepatitis) were acknowledged as important risks with daclizumab.
Večinoma so bili najdeni primeri asimptomatičnega dviga ravni transaminaz, vendar pa so bili nizka pojavnost resnih poškodb jeter in redki smrtni primeri odpovedi jeter (avtoimunski hepatitis) priznani kot pomembna tveganja v zvezi z daklizumabom.
In addition, prompt recognition of signs and symptoms of liver injury is a key component of risk minimisation for liver injury with daclizumab and these should be monitored in all patients.
Hitro prepoznavanje znakov in simptomov poškodbe jeter je ključna sestavina ukrepov za zmanjševanje tveganja poškodbe jeter zaradi daklizumaba, zato mora zdravnik pri vsakem bolniku le-te redno spremljati.
However, a number of serious hepatic events in patients in daclizumab groups occurred in the setting of concomitant drugs with known hepatotoxic potential, including one fatal autoimmune hepatitis and one non-fatal hepatic failure assessed by an adjudication committee as probable Hy's Law (indicative of a risk of drug-induced severe liver injury).
Vendar so se številni resni dogodki v zvezi z jetri v skupinah bolnikov, ki so prejemale daklizumab, pripetili v okoliščinah sočasnega jemanja zdravil z znanim hepatotoksičnim potencialom, in so vključevali en primer kroničnega avtoimunskega hepatitisa s smrtnim izidom in en primer odpovedi jeter brez smrtnega izida, katerega je razsodbena komisija ocenila kot možni Hyjev zakon (ki je indikativen za tveganje resnih poškodb jeter zaradi zdravil).
During the clinical development, transaminases elevations and serious hepatic injury were identified as important identified risks.
Med kliničnim razvojem je bilo ugotovljeno, da sta dvig ravni transaminaz in resna poškodba jeter pomembni tveganji.
However, in view of the seriousness of the reactions reported, leading in one case to a fatal outcome despite adherence to the recommended RMMs, the EC considered that the impact of the risk of liver injury on the benefit-risk balance of the medicinal product and the adequacy of the related RMMs should be reviewed.
Vendar glede na resnost zabeleženih neželenih učinkov, ki so se v enem primeru kljub izvajanju priporočenih ukrepov za zmanjšanje tveganja končali s smrtnim izidom, Evropska komisija meni, da je potrebno ponovno pregledati vpliv tveganja poškodbe jeter na razmerje med tveganji in koristmi zdravila, kot tudi primernost obstoječih ukrepov za zmanjšanje tveganja.
In view of the restricted indication and contraindication in patients with pre-existing hepatic disease or hepatic impairment, the PRAC recommended that physicians should re-evaluate promptly whether daclizumab continues to be an appropriate treatment option for each of their patients currently treated with this medicinal product, taking into account the provisional measures recommended by the PRAC.
Glede na omejitev indikacije in kontraindikacijo pri bolnikih s predhodno obstoječim obolenjem jeter ali okvaro jeter odbor PRAC priporoča, naj zdravniki pri vseh svojih bolnikih, ki se zdravijo z daklizumabom, čim hitreje ponovno ocenijo, ali je zdravljenje z daklizumabom zanje še vedno primerno, pri čemer morajo upoštevati začasne ukrepe, ki jih priporoča odbor PRAC.
In addition 4 cases of serious liver injury were reported from clinical trials, in the first periodic safety update report (PSUR).
Poleg tega so bili v redno posodobljenem poročilu o varnosti zdravila (PSUR) zabeleženi še štirje primeri resne poškodbe jeter v okviru kliničnega preskušanja.
It was also noted that autoimmune thyroiditis was reported in the recent fatal case as well as in one of the Hy's law adjudicated cases; therefore treatment initiation is not recommended in patients with history of concurrent autoimmune conditions.
Opaženo je bilo tudi, da je bila tako pri smrtnem primeru, kot pri enem izmed obravnavanih primerov Hyjevega zakona zabeležena tudi avtoimunska bolezen ščitnice, zato uvedba zdravljenja ni priporočljiva pri bolnikih, ki so v preteklosti imeli sočasna avtoimunska obolenja.
Therefore, while the magnitude and nature of the risk are being reviewed in depth, having considered the seriousness of the risk and that further RMMs that would be effective in preventing with certainty any new severe cases cannot be identified at this stage, the PRAC considered that it is necessary to provisionally limit the use of daclizumab through restriction of the indication and through preventing its use in patients potentially predisposed to liver injury and provide further recommendations to healthcare professionals (HCPs) and patients in the management of this risk.
Zato odbor PRAC meni, da je poleg temeljite raziskave glede stopnje in narave tveganja, ob upoštevanju resnosti tveganja, kakor tudi dejstva, da nadaljnjih ukrepov za učinkovito in zanesljivo zmanjšanje tveganja ob tem času ni mogoče določiti, treba začasno omejiti uporabo daklizumaba v smislu omejitve indikacije in preprečevanja uporabe zdravila pri bolnikih, ki so morebitno nagnjeni k poškodbam jeter, ter zdravstvenim delavcem in bolnikom zagotoviti nadaljnja priporočila o obvladovanju tveganj.
Thus, considering the serious risk of hepatic injury along with the benefit that daclizumab may bring to RMS patients, the PRAC recommended that the use of daclizumab should be provisionally restricted to adult patients with highly active RMS despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or, with rapidly evolving severe relapsing multiple sclerosis who are unsuitable for treatment with other DMTs.
Zato odbor PRAC glede na resno tveganje poškodbe jeter in po drugi strani koristi daklizumaba za bolnike z recidivno multiplo sklerozo priporoča začasno omejitev uporabe daklizumaba samo na odrasle osebe z visoko aktivno recidivno multiplo sklerozo, prisotno kljub izvedbi celovitega in ustreznega zdravljenja z vsaj enim zdravilom, ki spreminja potek bolezni (DMT), ali na odrasle osebe s hitro napredujočo recidivno multiplo sklerozo, ki niso primerne za zdravljenje z drugimi zdravili DMT.
HCPs and patients should be informed of the post-marketing fatal case of fulminant liver failure, the common risk of hepatitis and the updated frequency of serious cases of hepatic injury in the light of the new cases.
Glede na omenjene nove primere je treba zdravstvene delavce in bolnike obvestiti o smrtnem primeru fulmnantne jetrne odpovedi, ki se je zgodil v obdobju po izdaji dovoljenja za promet, splošnem tveganju za pojav hepatitisa ter posodobljeni pogostnosti resnih primerov poškodbe jeter.
¾ The need to inform patients about the risks of Libertek and the precautions for safe use.
¾ Obveznost informiranja bolnikov o tveganjih zdravila Libertek in previdnostnih ukrepih za varno uporabo.
Libertek is contraindicated in patients with moderate or severe liver impairment (Child Pugh B or C).
Libertek je kontraindiciran pri bolnikih z zmerno ali hudo okvaro jeter (Child Pugh B ali C).
Libertek is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Libertek ni priporočljiv za bolnike z anamnezo depresije, ki je bila povezana s samomorilnimi mislimi ali vedenjem.
• Copies of the patient card to be given to patients before they receive Libertek
• Kopije kartic za bolnike, ki naj bi jih bolniki prejeli pred začetkom jemanja zdravila Libertek
¾ The potential cardiac risk: Libertek has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
¾ Potencialno tveganje za srce: zdravilo Libertek ni bilo raziskano pri bolnikih s kongestivnim srčnim popuščanjem (NYHA stopnje 3 in 4); za to populacijo ni priporočljiv.
¾ The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Libertek should not be initiated or should be stopped in these patients.
¾ Pomanjkanje izkušenj pri bolnikih z okužbo HIV ali aktivnim hepatitisom, z resnimi imunološkimi boleznimi (npr. multiplo sklerozo, eritematoznim lupusom, multifokalno leukoencefalopatijo) ali na zdravljenju z imunosupresivnimi zdravili (razen kratkotrajnega zdravljenja s sistemskimi kortikosteroidi) in zdravila Libertek se pri teh bolnikih ne sme uvajati oz. ga je treba ukiniti.
The fact that Libertek is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
Dejstvo, da zdravilo Libertek ni indicirano za zdravljenje bolnikov s KOPB, razen tistih, ki ustrezajo odobreni indikaciji, ni primeren za uporabo pri bolnikih z astmo ali pomanjkanjem alfa-1-antitripsina.
Libertek should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Zdravila Libertek se ne sme uvajati oz. ga je treba ukiniti pri bolnikih z rakom (z izjemo bazalnoceličnega karcinoma).
• The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Libertek are provided with an Educational pack.
• Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo imeli ob uvajanju vsi zdravniki, ki bodo predpisovali zdravilo Libertek, na razpolago izobraževalno gradivo.
¾ The potential risk of infections: Libertek should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
¾ Potencialno tveganje za okužbe: zdravila Libertek se ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
¾ The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Libertek and the potential risk of suicide.
¾ Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Libertek in potencialno tveganje za samomor.
• Summary of Product Characteristics and Patient Information Leaflet for Libertek
• Povzetek glavnih značilnosti zdravila in Navodilo za uporabo zdravila Libertek
That Libertek may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Da zdravilo Libertek lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na kartico za bolnike.
14 January 2016 EMA/168579/2015
14. januar 2016 EMA/168579/2015
Ambroxol and bromhexine medicines have been authorised in: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
Zdravila z ambroksolom in bromheksinom so bila odobrena: v Avstriji, Belgiji, Bolgariji, na Hrvaškem, Cipru, v Češki republiki, na Danskem, v Estoniji, na Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, v Islandiji, na Irskem, v Italiji, Latviji, Litvi, Luksemburgu, na Malti, Nizozemskem, Norveškem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji in na Švedskem.
As these medicines have been authorised via national procedures, approved uses are not the same in all EU countries.
Ker so bila ta zdravila odobrena po nacionalnih postopkih, odobrena uporaba ni enaka v vseh državah EU.
The review of ambroxol and bromhexine was initiated on 4 April 2014 at the request of Belgium, under Article 31 of Directive 2001/83/EC.
Pregled ambroksola in bromheksina se je začel 4. aprila 2014 na zahtevo Belgije v skladu s členom 31 Direktive 2001/83/ES.
Frequencies of these side effects are unknown.
Pogostnost teh neželenih učinkov ni znana.
1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
1 Skupina CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU).
The majority of these medicines are available over the counter, whereas some are prescription-only medicines, depending on the condition to be treated and how the treatment is given.
Večina teh zdravil je na voljo brez recepta, nekatera pa so samo na recept, odvisno od zdravljenega stanja in načina dajanja.
This position was then sent to the European Commission which issued an EU-wide legally binding decision on 14/01/2016.
Stališče so nato posredovali Evropski komisiji, ki je 14. 1. 2016 izdala končno pravno zavezujočo odločbo za vso EU.
Risk of allergy and skin reactions included in the product information
Tveganje za alergijo in reakcije na koži vključeno v informacije o zdravilu
As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and issued an EU-wide legally binding decision.
Ker je skupina CMDh svoje stališče sprejela z večino glasov, so ga poslali Evropski komisiji, ki ga je podprla in izdala končno pravno zavezujočo odločbo za vso EU.
Reports of severe allergic reactions and SCARs in patients taking the medicines are rare, and the frequencies of these side effects are unknown.
Poročila o resnih alergijskih reakcijah in SCAR pri bolnikih, ki jemljejo ta zdravila, so redka, pogostnosti teh neželenih učinkov pa so neznane.
The CMDh first adopted a position by majority vote in February 2015, following which the European Commission requested clarifications on the PRAC recommendation and CMDh position.
Skupina CMDh je najprej februarja 2015 sprejela stališče z večino glasov, nato pa je Evropska komisija zahtevala pojasnila o priporočilu odbora PRAC in stališču CMDh.
Ambroxol and bromhexine expectorants: safety information updated
Ekspektoransi z ambroksolom in bromheksidinom: posodobljene informacije o varnosti
A revised CMDh position was subsequently adopted, by majority vote in November 2015.
Novembra 2015 je bilo z večino glasov sprejeto revidirano stališče skupine CMDh.
Some of these injectable formulations are also used to increase lung development before birth.
Nekateri izmed teh pripravkov za injiciranje se uporabljajo tudi za pospešitev razvoja pljuč pred rojstvom.
As ambroxol- and bromhexine-containing medicines are all authorised nationally, the PRAC recommendation was forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), for a position.
Ker so vsa zdravila, ki vsebujejo ambroksol in bromheksin, odobrena na nacionalni ravni, so bila priporočila odbora PRAC posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je morala sprejeti stališče.
• If you are taking ambroxol or bromhexine and have any questions or concerns speak to your doctor of pharmacist.
• Če jemljete ambroksol ali bromheksin in imate vprašanja ali vas kaj skrbi, se pogovorite z zdravnikom ali farmacevtom.
• If you experience skin reactions such as skin swellings or rash, stop treatment immediately and contact your doctor.
• Če se pri vas pojavijo kožne reakcije, kot je otekanje kože ali izpuščaj, nemudoma prekinite zdravljenje in se obrnite na svojega zdravnika.
The recommendations were originally made by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed the previously known risk of allergic reactions and also identified a small risk of SCARs, a group of skin conditions which include erythema multiforme and Stevens-Johnson syndrome.
Priporočila je prvotno pripravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) agencije EMA, ki je potrdil predhodno znano tveganje za alergijske reakcije in ugotovil manjše tveganje za SCAR, skupino kožnih stanj, ki vključujejo multiformni eritem in Stevens-Johnsonov sindrom.
The medicines are widely available in the EU for use as expectorants (to help clear mucus from the airways).
Ta zdravila so v EU široko dostopna in se uporabljajo kot ekspektoransi (za pomoč pri čiščenju sluzi iz dihal).
As a result, SCARs are now listed as side effects in the product information for these medicines, and patients are to stop treatment immediately if symptoms of SCARs occur.
Zato so SCAR zdaj navedeni kot neželeni učinki v informacijah o zdravilu za ta zdravila, bolniki pa morajo v primeru pojava simptomov SCAR zdravljenje nemudoma prekiniti.
Injectable formulations are also used to prevent and treat lung complications following surgery.
Pripravki za injiciranje se uporabljajo tudi za preprečevanje in zdravljenje zapletov s pljuči po kirurškem posegu.
• Advise your patients that they should stop treatment immediately if symptoms of progressive skin rash occur.
• Bolnikom svetujte, naj v primeru pojava simptomov napredujočega izpuščaja na koži nemudoma prekinejo zdravljenje.
Ambroxol formulations for injection are also used in premature and newborn babies to treat respiratory distress syndrome, a condition in which the baby's lungs are too immature for the baby to breathe properly.
Pripravki ambroksola za injiciranje se uporabljajo tudi pri nedonošenčkih in novorojenčkih za zdravljenje sindroma respiratorne stiske, tj. stanja, pri katerem dojenček zaradi nezrelih pljuč ne more pravilno dihati.
On 18 November 2015, the CMDh1 endorsed by majority vote recommendations to update the product information for ambroxol- and bromhexine-containing medicines with information about the small risk of severe allergic reactions and severe cutaneous adverse reactions (SCARs).
Dne 18. novembra 2015 je skupina CMDh1 z večino glasov podprla priporočila, da se informacije o zdravilu za zdravila, ki vsebujejo ambroksol in bromheksin, posodobijo z informacijami o manjšem tveganju za resne alergijske reakcije in hude kožne neželene učinke (SCAR).
In making the recommendations, the PRAC evaluated available data on ambroxol and bromhexine, including reports of severe allergic reactions or SCARs.
Pri oblikovanju priporočil je odbor PRAC ovrednotil razpoložljive podatke o ambroksolu in bromheksinu, vključno s poročili o resnih alergijskih reakcijah in SCAR.
Ambroxol- and bromhexine-containing medicines are marketed as single products or as fixed combination products with various other active ingredients.
Zdravila, ki vsebujejo ambroksol in bromheksin, se tržijo kot samostojna zdravila ali kot zdravila v fiksni kombinaciji z različnimi drugimi zdravilnimi učinkovinami.
EU Member States, and is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Skupina CMDh je regulativni organ, ki zastopa države članice EU in je odgovorna za zagotavljanje usklajenih varnostnih standardov za zdravila, odobrena po nacionalnih postopkih, po vsej EU.
• As ambroxol is a metabolite of bromhexine, the risk of anaphylactic and severe cutaneous reactions is considered to apply also to bromhexine.
• Ker je ambroksol presnovek bromheksina, tveganje za anafilaktične in hude kožne reakcije velja tudi za bromheksin.
• The risk of anaphylactic reactions and SCARs with ambroxol or bromhexine is low.
• Tveganje za anafilaktične reakcije in SCAR pri ambroksolu ali bromheksinu je majhno.
Ambroxol and bromhexine are mainly used by mouth as expectorants to help make the mucus thinner and therefore easier to be cleared away in patients with short- or long-term diseases of the lungs or airways.
Ambroksol in bromheksin se v glavnem uporabljata peroralno kot ekspektoransa, ki pri bolnikih s kratkotrajnimi ali dolgotrajnimi boleznimi pljuč ali dihal pripomoreta k redčenju in čiščenju sluzi.
• Anaphylactic reactions and severe cutaneous adverse reactions (SCARs), including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis, have been reported in patients receiving ambroxol.
• Pri bolnikih, ki prejemajo ambroksol, so poročali o anafilaktičnih reakcijah in hudih kožnih neželenih učinkih (SCAR), vključno z multiformnim eritemom, Stevens-Johnsonovim sindromom/toksično epidermalno nekrolizo in akutno generalizirano eksantematozno pustulozo.
For ambroxol, lozenge formulations are also available to relieve sore throat.
Ambroksol je na voljo tudi v obliki pastil za lajšanje bolečega grla.
• There is a small risk of allergy and skin reactions with ambroxol and bromhexine used as expectorants to clear mucus in the airways.
• Pri ambroksolu in bromheksinu, ki se uporabljata kot ekspektoransa za čiščenje sluzi v dihalih, obstaja majhno tveganje za alergijo in kožne reakcije.
1495-131 Algés, Lisbon Portugal ventilan
1495-131 Algés, Lisbon
Glaxo Wellcome Farmacêutica, Lda.
Portugalska Glaxo Wellcome Farmacêutica, Lda.
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Torre 3 - 12, 1099-036 Portugal isoxsuprine Dilum Retard 30mg tableta s podaljšanim sproščanjem
VENTOLIN®, soluţie injectabilă, 0,5 mg/ml
VENTOLIN®, soluţie injectabilă, 0,5 mg/ml parenteralna uporaba
Partusisten, concentraat voor oplossing voor intraveneuze infusie 50 microgram/ml
Partusisten, concentraat voor oplossing voor intraveneuze infusie 50 microgram/ml koncentrat za raztopino za infundiranje
Pharmaceutical forms
Farmacevtsk a oblika
Ventolin 1mg/ml Concentrate for Solution for Intravenous Infusion
Ventolin 1mg/ml Concentrate for Solution for Intravenous Infusion koncentrat za raztopino za intravensko infundiranje