natgillin/translations-raw huggingface dataset:
In order to prompt the attention of the recipients of the product information on the clinical situations above described, a warning to not use HES solutions for infusion in septic, renal impaired and critically ill patients should be mentioned at the top of the SmPC and PL.
Da bi pritegnili pozornost prejemnikov informacij o zdravilu v zvezi z zgoraj opisanimi kliničnimi situacijami, mora biti na vrhu povzetka glavnih značilnosti zdravila in navodila za uporabo navedeno opozorilo, da se raztopine HES za infundiranje ne smejo uporabljati pri bolnikih s sepso, ledvično okvaro in kritično bolnih bolnikih.
The PRAC also noted that the current clinical experience suggests that it is difficult to clearly separate patient populations where randomised clinical trials have shown serious harm from populations targeted by the approved indication.
Odbor PRAC je opozoril tudi, da dosedanje klinične izkušnje kažejo, da je populacije bolnikov, pri katerih so randomizirana klinična preskušanja pokazala resne škodljive posledice, težko ločevati od populacij, ki jim je namenjena odobrena indikacija.
• The PRAC reviewed all newly available data, including results from Drug Utilisation Studies (DUS), clinical studies, meta-analyses of clinical studies, post-marketing experience, Eudravigilance data, literature review, responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, stakeholders' submissions and views expressed by experts during an ad-hoc experts meeting.
• odbor PRAC je pregledal vse nove razpoložljive podatke, vključno z rezultati študij o uporabi zdravil, kliničnih študij, metaanaliz kliničnih študij, izkušnjami iz obdobja trženja, podatki Eudravigilance, pregledom literature, odgovori, ki so jih imetniki dovoljenj za promet z zdravilom predložili pisno in med ustno obrazložitvijo, predložitvami deležnikov ter stališči strokovnjakov, ki so jih ti izrazili na ad-hoc sestanku.
The PRAC also required that drug utilisation should be studied to evaluate the effectiveness of the risk minimisation measures.
Odbor PRAC je zahteval tudi, da se preuči uporaba zdravila, in sicer za ovrednotenje učinkovitosti ukrepov za zmanjševanje tveganja.
Is it also noted that although the benefit has been demonstrated in terms of a volume-sparing effect, and there is some support for short-term hemodynamic effects, it remains uncertain to what extent this translates into more patient-relevant outcomes.
Opozoriti je treba tudi, da čeprav so dokazali koristi v smislu učinka ohranjanja volumna in čeprav obstaja nekaj dokazov za kratkotrajne hemodinamične učinke, je še vedno negotovo, kaj to pomeni za izide, povezane z bolnikom.
The benefit of HES solutions for infusion has been demonstrated in terms of volume-sparing effect, and there is some support for effects on short-term hemodynamic effects, although there is some uncertainty to what extent this translates into more patient-relevant outcomes.
Korist raztopin HES za infundiranje so dokazali v smislu učinka ohranjanja volumna, in čeprav obstaja nekaj dokazov za kratkotrajne hemodinamične učinke, še vedno obstaja nekaj negotovosti, kaj to pomeni za izide, povezane z bolnikom.
• Furthermore, the PRAC considered options for measures to further mitigate these risks, including changes to the product information, direct health care professional communication, educational materials, warning on the primary container of the products, sign-in for medication form, prescription sheet/checklists, restricted access and distribution system to accredited hospitals/physicians.
• odbor PRAC je preučil še možnosti ukrepov za nadaljnje zmanjšanje teh tveganj, vključno s spremembami informacij o zdravilu, neposrednimi obvestili za zdravstvene delavce, izobraževalnim gradivom, opozorilom na primarnem vsebniku zdravila, podpisovanjem obrazca za zdravilo, listi/kontrolnimi seznami za recepte, sistemom omejenega dostopa in distribucije akreditiranim bolnišnicam/zdravnikom.
(2) Addition of a prominent warning at the top of the SmPC and PL.
(2) Dodatek dobro vidnega opozorila na vrhu povzetka glavnih značilnosti zdravila in navodila za uporabo
Revised grounds for PRAC recommendation
Revidirana podlaga za priporočilo odbora PRAC
However, the available evidence shows that the non-adherence is not only due to a lack of awareness of the restrictions by prescribers, rendering further communication and education unlikely to be sufficiently effective.
Vendar razpoložljivi dokazi kažejo, da neupoštevanje navodil ni le posledica dejstva, da predpisovalci ne poznajo omejitev, zato ni verjetno, da bi bilo nadaljnje obveščanje in izobraževanje dovolj učinkovito.
On 5th July 2017 and 9th October 2017, results from two DUSs on the effectiveness of the implemented risk minimisation measures have become available.
Rezultati dveh študij o uporabi zdravil glede učinkovitosti uvedenih ukrepov za zmanjševanje tveganja so postali na voljo 5. julija 2017 in 9. oktobra 2017.
FLASH study) would further characterise the efficacy and safety profile in elective surgery and trauma patients.
S temi študijami in potekajočimi prostovoljnimi kliničnimi študijami (npr. študijo FLASH) bi nadalje opredelili profil učinkovitosti in varnosti pri bolnikih z elektivnim kirurškim posegom in poškodovancih.
However, the available evidence shows that the non-adherence is not only due to a lack of awareness of the restrictions by prescribers but also due in some cases to deliberate choice, rendering further communication and education unlikely to be sufficiently effective to address the risks identified.
Vendar razpoložljivi dokazi kažejo, da neupoštevanje navodil ni le posledica dejstva, da predpisovalci ne poznajo omejitev, pač pa gre v nekaterih primerih za namerno odločitev, zato nadaljnje obveščanje in izobraževanje verjetno ne bo dovolj vplivalo na učinkovito za obravnavo prepoznanih tveganj.
The PRAC considered further risk minimisation measures which could potentially sufficiently minimise this exposure, including restricted access / distribution to hospitals and physicians, changes to the product information, direct health care professional communication, educational materials to be distributed in cooperation with some learned societies, warning on the primary container of the products, medication form and follow-up questionnaire.
Odbor PRAC je preučil še druge ukrepe za zmanjšanje tveganja, ki bi lahko v zadostni meri zmanjšali to izpostavljenost, vključno z omejenim dostopom/distribucijo bolnišnicam in zdravnikom, spremembami informacij o zdravilu, neposrednimi obvestili za zdravstvene delavce, izobraževalnim gradivom, ki bi se delilo v sodelovanju s strokovnimi združenji, opozorilom na primarnem vsebniku zdravil, obrazcem za zdravilo in kontrolnim vprašalnikom.
• Impact on the clinical practice of potential suspension of MA for HES solutions for infusion
• Vpliv morebitnega začasnega umika dovoljenj za promet z zdravilom za raztopine HES za infundiranje na klinično prakso
It is therefore considered that a DHPC with more targeted messages and with the involvement of the learned societies in the distribution of this DHPC is likely to reinforce the effectiveness of this measure.
Zato se šteje, da bi se učinkovitost tega ukrepa verjetno okrepila z bolj ciljno usmerjenimi neposrednimi sporočili za zdravstvene delavce in vključitvijo strokovnih združenj v razdeljevanje teh neposrednih sporočil.
As an outcome of the 2013 referral, post-authorisation studies were imposed to the MAHs in these clinical settings and are a condition to the terms of the MAs for HES solutions for infusion.
Kot izid napotitve iz leta 2013 so od imetnikov dovoljenj za promet z zdravilom zahtevali študije po izdaji dovoljenja za promet z zdravilom v okviru tovrstnega kliničnega zdravljenja, ki so bile pogoj za dovoljenja za promet z zdravilom za raztopine HES za infundiranje.
The PRAC considered other further risk minimisation measures to sufficiently minimise this exposure, including changes to the product information, direct health care professional communication, educational materials, warning on the primary container of the products, sign-in for medication form, prescription sheet/checklists.
Odbor PRAC je preučil še druge ukrepe za zmanjšanje tveganja, s katerimi bi v zadostni meri zmanjšali to izpostavljenost, vključno s spremembami informacij o zdravilu, neposrednimi obvestili za zdravstvene delavce, izobraževalnim gradivom, opozorilom na primarnem vsebniku zdravila, podpisovanjem obrazca za zdravilo, listi/kontrolnimi seznami za recepte.
These data raise serious concerns as they showed use of HES solutions for infusion in patient populations which are contraindicated such as those who are critically ill, or with sepsis3,4,5.
infundiranje uporabljajo pri populacijah bolnikov, pri katerih so kontraindicirane, na primer pri kritično bolnih ali bolnikih s sepso3, 4, 5.
- The MAH should deliver the training on the appropriate use of HES solutions for infusion to relevant HCPs on a regular basis, as agreed with the national competent authorities.
- Imetnik dovoljenja za promet z zdravilom mora redno, po dogovoru z nacionalnimi pristojnimi organi, izvajati usposabljanja o primerni uporabi raztopin HES za infundiranje za zadevne zdravstvene delavce.
Overall non-adherence to the revised product information was reported to be high, and PRAC was particularly concerned that approximately 9% of patients exposed to HES solutions for infusion were critically ill, approximately 5-8% of patients had renal impairment and approximately 3-4% of patients had sepsis.
Odbor PRAC je bil zlasti zaskrbljen, da je bilo približno 9 % bolnikov, izpostavljenih raztopinam HES za infundiranje, kritično bolnih, da je imelo približno 5-8 % bolnikov ledvično okvaro in približno 3-4 % bolnikov sepso.
Grounds for differences with the PRAC recommendation
Podlaga za odstopanja od priporočila odbora PRAC
However, the available evidence shows that the non-adherence is not only due to a lack of awareness of the restrictions by prescribers but also due to deliberate choice, rendering further communication and education unlikely to be sufficiently effective to address the risks identified.
neupoštevanje navodil ni le posledica dejstva, da predpisovalci ne poznajo omejitev, pač pa gre tudi za namerno odločitev, zato ni verjetno, da bi bilo nadaljnje obveščanje in izobraževanje dovolj učinkovito za obravnavo prepoznanih tveganj.
Therefore, the CMDh is of the position that each MAH shall be responsible for the implementation and the supervision of the access controlled program as follows: - The MAH should develop the training materials for relevant HCPs expected to prescribe / administer HES solutions for infusion and agree the exact content and format of these materials with the relevant national competent authorities.
- Imetnik dovoljenja za promet z zdravilom mora pripraviti gradivo za usposabljanje zadevnih zdravstvenih delavcev, ki naj bi predpisovali/dajali raztopine HES za infundiranje, in se glede natančne vsebine in oblike tega gradiva dogovoriti z ustreznimi nacionalnimi pristojnimi organi.
Therefore the CMDh recommends the variation to the terms of the marketing authorisations for HES solutions for infusion.
Zato priporoča spremembo pogojev dovoljenj za promet z zdravilom za raztopine HES za infundiranje.
marketing authorisation for HES solutions for infusion would have an impact on the clinical practice where HES is reported as an adequate therapeutic option.
Upoštevala je zlasti rezultate posvetovanja držav članic, v katerih bi začasni umik dovoljenj za promet z zdravilom za raztopine HES za infundiranje vplival na klinično prakso, v okviru katere je HES primerna terapevtska možnost.
- are more than 3 months pregnant.
- ste noseči dlje kot 3 mesece.
Date of first authorisation: 7 December 2011 Date of latest renewal:
Datum pridobitve prvega dovoljenja: 7. december 2011 Datum zadnjega podaljšanja:
Take the tablet with plenty of water.
Tableto zaužijte z veliko vode.
Just take the next dose at the usual time.
Vzemite samo naslednji odmerek ob običajni uri.
Elderly (65 years and over)
Starejši (65 let in starejši)
Tablet.
tableta.
Therefore, this medicine should not be given to children or adolescents.
Tega zdravila se ne sme dajati otrokom ali mladostnikom.
However it should be taken into account that occasionally dizziness or tiredness may occur.
Vendar pa je treba upoštevati, da se lahko občasno pojavi omotica ali utrujenost.
You can take this medicine with or without food.
To zdravilo lahko jemljete skupaj s hrano ali brez nje.
It is important to keep taking Edarbi every day at the same time.
Pomembno je, da zdravilo Edarbi vzamete vsak dan ob istem času.
(It is also better to avoid this medicine in early pregnancy - see pregnancy section).
(Temu zdravilu se je bolje izogibati tudi v zgodnji nosečnostiglejte poglavje Nosečnost).
Other possible side effects include:
Drugi možni neželeni učinki vključujejo:
The volume of distribution of azilsartan is approximately 16 litres.
Volumen porazdelitve azilsartana je približno 16 litrov.
Therefore do not stop taking Edarbi without first talking to your doctor about alternative treatment options.
Zdravila Edarbi ne nehajte jemati, ne da bi se prej s svojim zdravnikom pogovorili o alternativnih možnostih zdravljenja.
Overall, 51% of patients were male and 26% were 65 years or older (5% ≥ 75 years); 67% were white and 19% were black.
51 % bolnikov je bilo moškega spola, 26 % jih je bilo starih 65 let ali več (5 % ≥ 75 let), 67 % je bilo belcev, 19 % temnopoltih.
Characteristics in specific groups of patients
Karakteristike pri posebnih skupinah bolnikov
Dual blockade of the RAAS
Dvojna blokada RAAS
This medicine is used for treating high blood pressure (essential hypertension) in adult patients (over 18 years of age).
To zdravilo se uporablja za zdravljenje visokega krvnega tlaka (esencialne hipertenzije) pri odraslih (starejših od 18 let).
However some people may feel tired or dizzy when taking this medicine and if this happens to you, do not drive or use any tools or machines.
Vendar lahko nekateri bolniki med jemanjem tega zdravila čutijo utrujenost ali omotico in če se to dogaja vam, ne vozite in ne uporabljajte orodij ali strojev.
These are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), including isolated reports.
Razvrščeni so po pogostnosti ob uporabi naslednjega dogovora: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), vključno s posameznimi primeri.
- The usual starting dose is 40 mg once a day.
- Običajni začetni odmerek je 40 mg enkrat na dan.
Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Edarbi.
Zdravnik vam bo praviloma svetoval, da to zdravilo prenehate jemati, preden boste zanosili ali takoj ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila Edarbi jemljete drugo zdravilo.
Pharmacokinetics of azilsartan do not differ significantly between young (age range 18-45 years) and elderly (age range 65-85 years) patients.
Farmakokinetika azilsartana se ni pomembno razlikovala med mlajšimi (18-45 let) in starejšimi (65-85 let) bolniki.
Edarbi can affect the way some other medicines work and some medicines can have an effect on Edarbi.
Zdravilo Edarbi lahko vpliva na delovanje nekaterih drugih zdravil in nekatera druga zdravila lahko vplivajo na delovanje zdravila Edarbi.
The frequency of this effect is highest when amlodipine is taken alone.
Pogostnost tega neželenega učinka je največja, če se jemlje samo amlodipin.
Azilsartan is highly bound to plasma proteins (> 99%), mainly serum albumin.
Azilsartan se močno veže na beljakovine v plazmi (> 99 %), v glavnem na serumski albumin.
The elimination half-life of azilsartan is approximately 11 hours and renal clearance is approximately 2.3 ml/min.
Razpolovni čas izločanja azilsartana je približno 11 ur, ledvični očistek pa je približno 2,3 ml/min.
Hemodialysis does not remove azilsartan from the systemic circulation.
Hemodializa ne odstrani azilsartana iz sistemskega obtoka.
If symptomatic hypotension should occur, supportive treatment should be instituted and vital signs monitored.
Zdravljenje Če pride do simptomatične hipotenzije, je treba uvesti podporno zdravljenje in nadzirati vitalne znake.
Many of these elevations were transient or nonprogressive while subjects continued to receive treatment.
Mnogi od teh dvigov koncentracije so bili prehodni ali neprogresivni v času, ko so udeleženci nadaljevali s terapijo.
The major enzyme responsible for azilsartan metabolism is CYP2C9.
Glavni encim, odgovoren za presnovo azilsartana, je CYP2C9.
Therefore, the use of Edarbi is not recommended in these patients.
Uporabe zdravila Edarbi pri teh bolnikih zato ne priporočamo.
Beneficial effects of Edarbi on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Ugodni vplivi zdravila Edarbi na umrljivost in srčno-žilno obolevnost ter na poškodbe ciljnega organa trenutno niso poznani.
This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano {MM/LLLL}.
The safety and efficacy of Edarbi in children and adolescents aged 0 to < 18 years have not yet been established.
Varnost in učinkovitost zdravila Edarbi pri otrocih in mladostnikih, starih 0 do < 18 let še nista bili dokazani.
This effect is also seen with other inhibitors of the RAAS.
Ta učinek je bil opažen tudi pri drugih zaviralcih RAAS.
- Second and third trimester of pregnancy (see sections 4.4 and 4.6).
- Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6).
Paediatric population The pharmacokinetics of azilsartan have not been studied in children under 18 years of age.
Pediatrična populacija Farmakokinetika azilsartana ni bila preučevana pri otrocih, mlajših od 18 let.
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Če se kombinacija izkaže za potrebno, priporočamo skrbno spremljanje koncentracije litija v serumu.
There is currently no experience on the use of Edarbi in patients who have recently undergone kidney transplantation.
Trenutno ni nobenih izkušenj z uporabo zdravila Edarbi pri bolnikih, ki so imeli pred kratkim presaditev ledvic.
Your doctor may need to change your dose and/or to take other precautions if you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Edarbi” and “Warnings and precautions”).
Zdravnik vam bo morda moral spremeniti odmerek in/ali upoštevati druge previdnostne ukrepe: Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila Edarbi" in "Opozorila in previdnostni ukrepi").
Hemoglobin and hematocrit
Hemoglobin in hematokrit
Edarbi is provided in blisters with either 14 tablets or 15 tablets in cartons containing 14, 28, 56 or 98 tablets and blisters integrated with desiccant with either 14 tablets or 15 tablets in cartons containing 14, 28, 30, 56, 90 or 98 tablets.
Zdravilo Edarbi je na voljo v pretisnih omotih po 14 ali 15 tablet v škatli, ki vsebuje 14, 28, 56 ali 98 tablet in pretisnih omotov z integriranim sušilnim sredstvom z ali 14 ali 15 tabletami v škatli, ki vsebuje 14, 28, 30, 56, 90 ali 98 tablet.
If you stop taking Edarbi, your blood pressure may increase again.
Če prenehate z jemanjem zdravila Edarbi, lahko krvni tlak znova naraste.
Edarbi is indicated for the treatment of essential hypertension in adults.
Zdravilo Edarbi je indicirano za zdravljenje esencialne hipertenzije pri odraslih.
A reduction in your blood pressure will be measureable within 2 weeks of initiation of treatment and the full effect of your dose will be observed by 4 weeks.
Znižanje krvnega tlaka se bo dalo izmeriti v 2 tednih po začetku zdravljenja in polni učinek vašega odmerka bo opaziti čez 4 tedne.
Effect on cardiac repolarisation
Vpliv na srčno repolarizacijo
In patients with mild, moderate, and severe renal impairment azilsartan total exposure (AUC) was +30%, +25% and +95% increased.
Pri bolnikih z blago, zmerno in hudo ledvično okvaro se je skupna izpostavljenost (AUC) azilsartana povečala za +30 %, oz. za +25 %, oz. za +95 %.
In vitro studies indicated that interactions based on esterase inhibition are unlikely.
In vitro študije so pokazale, da so interakcije na osnovi zaviranja esteraze, malo verjetne.
Key Secondary End Point:
Ključni sekundarni opazovani dogodek:
No overall differences in safety and effectiveness were observed between elderly patients and younger patients, but greater sensitivity to blood pressure lowering effects in some elderly individuals cannot be ruled out (see section 4.2).
Med mlajšimi in starejšimi bolniki ni bila opažena splošna razlika v varnosti in učinkovitosti, vendar pa ni mogoče izključiti večje občutljivosti za učinke znižanja krvnega tlaka pri nekaterih starejših posameznikih (glejte poglavje 4.2).
Edarbi had a lower incidence of cough (1.2%) compared with ramipril (8.2%).
Zdravilo Edarbi je imelo nižjo pogostnost kašlja (1,2 %) kot ramipril (8,2 %).
Azilsartan and M-II crossed the placenta and were found in the fetuses of pregnant rats and were excreted into the milk of lactating rats.
Azilsartan in M-II prehajata preko placente in sta bila najdena v fetusih nosečih podgan in izločena v mleko doječih podgan.
Whilst there are no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Čeprav ni na voljo kontroliranih epidemioloških podatkov glede tveganja pri uporabi antagonistov angiotenzina II, lahko podobno tveganje obstaja tudi za to skupino zdravil.
Patients with primary hyperaldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the RAAS.
Bolniki s primarnim hiperaldosteronizmom običajno ne reagirajo na zdravila proti hipertenziji, ki delujejo z zaviranjem RAAS.
The most common adverse reaction was dizziness.
Najpogostejši neželeni učinek je bila omotica.
Pharmacokinetics of azilsartan do not differ significantly between black and white populations.
Farmakokinetika azilsartana se med temnopolto in belo populacijo pomembno ne razlikuje.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
Manufacturer: Takeda Ireland Limited, Bray Business Park, Kilruddery, Co. Wicklow, Ireland
Izdelovalec: Takeda Ireland Limited, Bray Business Park, Kilruddery, Co. Wicklow, Irska
Do NOT take Edarbi if you - are allergic to azilsartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
NE jemljite zdravila Edarbi, če - ste alergični na medoksomilazilsartanat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The European Medicines Agency has deferred the obligation to submit the results of studies with Edarbi in one or more subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Edarbi za eno ali več podskupin pediatrične populacije s hipertenzijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Food does not affect the bioavailability of azilsartan (see section 4.2).
Hrana ne vpliva na biološko uporabnost azilsartana (glejte poglavje 4.2).
What Edarbi is and what it is used for
Kaj je zdravilo Edarbi in za kaj ga uporabljamo
Takeda Ireland Ltd. Bray Business Park Kilruddery Co Wicklow Ireland
Takeda Ireland Ltd. Bray Business Park Kilruddery Co Wicklow Irska
For Edarbi, olmesartan medoxomil and valsartan, respectively dizziness was observed at an incidence of 3.0%, 3.3% and 1.8%; headache at 4.8%, 5.5% and 7.6% and dyslipidemia at 3.5%, 2.4% and 1.1%.
Za zdravilo Edarbi, medoksomilolmesartanat in valsartan je bila omotica opažena s pogostnostjo 3,0 %, 3,3 % in 1,8 %, glavobol s pogostnostjo 4,8 %, 5,5 % in 7,6 % ter dislipidemija s pogostnostjo 3,5 %, 2,4 % in 1,1 %.