natgillin/translations-raw huggingface dataset:
It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Pomembno je, da poveste svojemu zdravniku, če dobite znake okuţbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
Clinical remission 12% 24% 36%*
24. teden 15 % 57 %***
Talk to your child's doctor or pharmacist before using Kromeya
Pred začetkom uporabe zdravila Kromeya se posvetujte z otrokovim zdravnikom ali farmacevtom.
Warning: Do not twist the cap.
Opozorilo: Pokrovčka ne vrtite.
• Hold the syringe like a pencil.
• Injekcijsko brizgo drţite tako kot pisalo.
Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Mannitol
6.1 Seznam pomoţnih snovi natrijev dihidrogenfosfat dihidrat dinatrijev fosfat dihidrat manitol natrijev klorid monohidrat citronske kisline natrijev citrat polisorbat 80 natrijev hidroksid (za uravnavanje pH) voda za injekcije
Note: P = Placebo (number at risk (flared)); A = Adalimumab (number at risk (flared)).
Opomba: P = Placebo (število rizičnih preiskovancev (zagon bolezni)); A = Adalimumab (število rizičnih preiskovancev (zagon bolezni)).
Do not try to reinsert it and use a new kit.
Uporabite nov komplet.
one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
Alcohol pads
Zloţenec prepojen z alkoholom
Needle Guard Spring
Zapora tankega črevesa
Talk to your doctor or pharmacist before using Kromeya
Pred začetkom uporabe zdravila Kromeya se posvetujte z zdravnikom ali farmacevtom.
1.7 Leave the pre-filled pen at room temperature for at least 30 minutes to allow the medicine to warm up (Figure F).
1.7 Injekcijski peresnik pustite na sobni temperaturi 30 minut, da se zdravilo ogreje.
In the OL LI phase all patients received 24 mg/m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m
• You might get infections more easily while you are receiving Kromeya treatment.
• Med zdravljenjem z zdravilom Kromeya se lahko poveča dovzetnost za okuţbe.
• psoriasis,
• luskavica (psoriaza),
Common
Konica
• If needed, for example when traveling, a single pre-filled pen can be stored at room temperature for up to 14 days.
• Po potrebi lahko posamezen napolnjen injekcijski peresnik shranjujete pri sobni temperaturi do
Intestinal perforation
Zaviranje vnetja
d score methotrexate
NALEPKA NA BRIZGI
• eye inflammation;
• okuţba očesa;
Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
pogosti karcinom koţe, ki ne vključuje malignega melanoma (vključno z bazalnoceličnim karcinomom in ploščatoceličnim karcinomom), benigni tumor občasni limfom**, tumorji parenhimskih organov (vključno s tumorjem dojk, tumorjem pljuč in tumorjem ščitnice) maligni melanom**,
Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
En 0,8 ml enoodmerni napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba.
• paediatric uveitis
• uveitis pri pediatrični populaciji
• stroke;
• vnetja.
Vascular disorders
Simptomi okuţbe
Step 6 Give your Injection
7. korak Zavrzite injekcijski peresnik
Mean steady-state trough levels of approximately 7 µg/mL were observed in Crohn's disease patients who received a maintenance dose of 40 mg adalimumab every other week.
Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrţevalni odmerek 40 mg adalimumaba vsak drugi teden, so ugotovili najniţjo koncentracijo pred naslednjim odmerkom v stanju dinamičnega ravnovesja pribliţno 7 µg/ml.
PASI 75 and PGA of clear or minimal response rates in these patients were 74.7% and 59.0%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov) sta bila pri teh bolnikih deleţ odziva PASI 75 74,7 % in deleţ odziva PGA "čisto" ali "minimalno" 59,0 %.
• Lift the pre-filled pen from your skin (Figure Q).
• Injekcijski peresnik odmaknite od koţe (Slika Q).
• hearing loss, buzzing;
• izguba sluha, šumenje v ušesih;
confidence interval)
Deleţ (95 % interval zaupanja)
Therefore, the combination of adalimumab and anakinra is not recommended.
Zato kombinacija adalimumaba in anakinre ni priporočljiva (glejte poglavje 4.5).
every week or 80 mg every other week.
20 mg vsak drugi teden 40 mg vsak drugi teden
Kromeya 40 mg solution for injection in pre-filled pen
Kromeya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
6.3 Insert the needle
6.3 Injiciranje
Liver failure
Nastavek za vialo
What you need to know before your child uses Kromeya
Kaj je zdravilo Kromeya in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok uporabil zdravilo Kromeya Kako uporabljati zdravilo Kromeya Moţni neţeleni učinki
Induction dose
občasni diplopija
Invented name Strength Pharmaceutical form Route of administration Packaging
Farmacevtska oblika Pot uporabe
EU Number
Številka EU dovoljenja za promet
Content
Stična ovojnina
The primary outcomes should be common to all studied EU Member States.
Primarni izidi morajo biti skupni za vse preučevane države članice EU.
The effectiveness of this measure should be considered in combination with other measures.
Učinkovitost tega ukrepa je treba obravnavati skupaj z drugimi ukrepi;
Hence:
Torej:
These include drug utilisation data from 11 EU Member States.
Vključevali so podatke o uporabi zdravil iz 11 držav članic EU.
Protocols should include a representative sample of EU Member States.
Protokoli morajo vključevati reprezentativen vzorec držav članic EU.
These views often reflected the current national medical practice and the debate in the medical community.
Ta stališča so pogosto odražala trenutne nacionalne medicinske prakse in razpravo v medicinski skupnosti.
This includes recordings of trainings and accreditation.
To vključuje tudi evidence usposabljanj in akreditacije.
However, this measure should be seen as part of the complete program of risk minimisation measures.
Vendar je treba ta ukrep obravnavati kot del celovitega programa ukrepov za zmanjšanje tveganja.
• Proposals for additional risk minimisation measures and pharmacovigilance activities
• Predlogi za dodatne ukrepe za zmanjšanje tveganja in farmakovigilančne aktivnosti
The frequency of the training / reminders should be discussed at national level taking consideration particularities of each national healthcare system.
O pogostnosti usposabljanja/opomnikov se je treba dogovoriti na nacionalni ravni, in sicer z upoštevanjem posebnosti zdravstvenega sistema posamezne države;
The PRAC discussed the above two points at its May meeting, taking into consideration information provided by the Member States.
Odbor PRAC je razpravljal o zgornjih dveh točkah na svojem majskem sestanku in upošteval informacije, ki so jih predložile države članice.
• This measure will act as a reminder at time of administration, which is important in an emergency setting.
• ta ukrep bo deloval kot opomnik ob času dajanja, kar je pomembno pri nujnih primerih.
Revised CMDh position
Revidirano stališče skupine CMDh
Overall, the evidence for this indication is based on studies for which the sample size and the duration of follow-up are limited.
Dokazi pri tej indikaciji na splošno temeljijo na študijah, v katerih sta bila velikost vzorca in trajanje spremljanja omejena.
The CMDh emphasised the importance of having meaningful results from these studies as soon as possible.
Skupina CMDh je poudarila, da je zelo pomembno čim prej pridobiti tehtne rezultate teh študij.
These views, along with all substantial data and information crucial for the full understanding of these views have been either shared with all the parties involved or otherwise made available in the course of the procedure.
Ta stališča so bila skupaj z vsemi bistvenimi podatki in informacijami, ki so ključnega pomena za celovito razumevanje teh stališč, posredovana vsem vključenim osebam ali so bila kako drugače na voljo v teku postopka.
The PRAC also consulted an ad-hoc expert group and considered carefully views expressed during the meeting that took place on 18 December 2017.
Odbor PRAC se je posvetoval tudi z ad-hoc skupino strokovnjakov in skrbno upošteval stališča, izražena med sestankom, ki je potekal 18. decembra 2017.
Communication measures
Ukrepi za obveščanje
• The continued presence of this warning on the packaging will also contribute to long-term awareness of HPCs.
• stalna prisotnost tega opozorila na ovojnini bo prispevala tudi k dolgoročni ozaveščenosti zdravstvenih delavcev;
This controlled access program should be described in a Risk Management Plan which shall be submitted to the National Competent Authorities for assessment within 3 months from the Commission Decision.
Ta program nadzorovanega dostopa je treba opisati v načrtu za obvladovanje tveganja, ki ga je treba predložiti nacionalnim pristojnim organom v oceno v treh mesecih od sklepa Komisije.
This reflects a long-standing controversy among health-care professionals and echoes the range of stakeholder responses received in the current review.
To odraža dolgoletno polemiko med zdravstvenimi delavci in razpon odzivov deležnikov, prejetih med trenutnim pregledom.
In terms of readability, the warning should be strongly emphasised (e.g. capitalized, bold letters or use of colours).
V smislu berljivosti mora biti opozorilo močno poudarjeno (npr. s krepkimi, velikimi tiskanimi črkami ali z uporabo barv).
In light of the well-established risk for serious harm when HES solutions for infusion are used in patients with critical illness, including sepsis, together with the above-mentioned newly available data, Sweden triggered, on 17th October 2017, an urgent Union procedure under Article 107i of Directive 2001/83/EC.
V luči dobro znanega tveganja za resne škodljive posledice uporabe raztopin HES za infundiranje pri bolnikih s kritično boleznijo, vključno s sepso, skupaj z zgoraj omenjenimi novimi podatki, je Švedska 17. oktobra 2017 sprožila nujni postopek Unije v skladu s členom 107i Direktive 2001/83/ES.
These views are based on PRAC members' routine review processes and preparation.
Ta stališča temeljijo na rutinskih pregledih in pripravi članov odbora PRAC.
Progress on the ongoing DUS shall be reported within the upcoming PSUR.
O napredku trenutne študije o uporabi zdravil je treba poročati v naslednjem poročilu PSUR.
The PRAC adopted a recommendation on 11 January 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Odbor PRAC je 11. januarja 2018 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
This complicates effective risk minimisation in these patients.
Tako se učinkovito zmanjšanje tveganja pri teh bolnikih zaplete.
It will complement other measures such as training to HCPs.
Dopolnjeval bo druge ukrepe, kot je usposabljanje zdravstvenih delavcev;
The PRAC duly considered the view of the majority of the experts in the meeting that HES is used in clinical practice.
Odbor PRAC je ustrezno upošteval stališče večine strokovnjakov na sestanku, da se HES uporablja v klinični praksi.
The position was afterwards forwarded to the European Commission, the Member States, to Iceland and Norway and to the marketing authorisation holders for the above mentioned medicinal products, together with its annexes and appendices.
Svoje stališče je nato posredovala Evropski komisiji, državam članicam, Islandiji in Norveški ter imetnikom dovoljenj za promet z zdravilom za zgoraj navedena zdravila, skupaj s prilogami in dodatki.
During the decision-making process, at a meeting of the Standing Committee on Medicinal Products for Human Use, some EU Member States raised new questions of technical nature which they considered had not been sufficiently addressed in the PRAC recommendation and CMDh position.
Med odločanjem na sestanku Stalnega odbora za zdravila za uporabo v humani medicini so nekatere države članice EU sprožile nova vprašanja tehnične narave, za katera so menile, da v priporočilu odbora PRAC in stališču skupine CMDh niso bila obravnavana v zadostni meri.
They should also allow adequate description of national contexts to guarantee the adequate analysis and extrapolation of the outcome and justify potential adjustments (i.e. successful/unsuccessful distribution of safety communications, adherence to the controlled access program, qualitative feedback from prescribers, etc).
Omogočati morajo tudi ustrezen opis nacionalnih okvirov, kar zagotavlja ustrezno analizo in ekstrapolacijo izida ter utemeljitev morebitnih prilagoditev (tj. uspešno/neuspešno razdeljevanje obvestil o varnosti, upoštevanje programa nadzorovanega dostopa, kvalitativne povratne informacije od predpisovalcev itd.).
The training materials should be based on interactive learning tools in order to ensure the active involvement of the HCPs.
Gradivo za usposabljanje mora temeljiti na interaktivnih učnih orodjih, ki zagotavljajo aktivno vključenost zdravstvenih delavcev.
Hydroxyethyl starch (HES) solutions for infusion contain starch with different molecular weights (mainly 130kD; 200kD) and substitution ratio (the number of hydroxyethyl groups per glucose molecule).
Raztopine hidroksietil škroba (HES) za infundiranje vsebujejo škrob različnih molekulskih mas (večinoma 130 kD; 200 kD) in substitucijskih vzorcev (število hidroksietilnih skupin na molekulo glukoze).
HES solutions for infusion are authorised worldwide for the treatment of hypovolaemia associated with various conditions.
Raztopine HES za infundiranje so odobrene po vsem svetu za zdravljenje hipovolemije, povezane z različnimi stanji.
• A reference to section 4.3 of the SmPC will avoid undermining the importance of other contraindications, and ensure these continue to be adhered to.
• sklic na poglavje 4.3 povzetka glavnih značilnosti zdravila bo preprečil slabitev pomena drugih kontraindikacij in zagotovil njihovo nadaljnje upoštevanje.
The benefits in the approved indication therefore remain modest.
Koristi pri odobreni indikaciji torej ostajajo skromne.
• The PRAC also noted the overall exposure to HES solutions for infusion in the EU, estimated to about 1.5 to 2 million patients per year since 2014.
• odbor PRAC je opozoril tudi, da je skupna izpostavljenost raztopinam HES za infundiranje v EU od leta 2014 ocenjena na približno 1,5 do 2 milijona bolnikov na leto.
The safety concerns of primary importance in this referral are increased mortality and a higher incidence of renal failure - the opposite of the benefit expected.
Najpomembnejši varnostni pomisleki v tej napotitvi so povečana umrljivost in večja pojavnost ledvične odpovedi, kar je ravno nasprotno od pričakovane koristi.
In view of the above and whilst noting the PRAC's reservations on the expected effectiveness of this measure, notably in view of the non-adherence by prescribers not only due to a lack of awareness, the CMDh considered that:
Glede na zgoraj navedeno in z upoštevanjem zadržkov odbora PRAC glede pričakovane učinkovitosti tega ukrepa, predvsem v smislu neupoštevanja s strani predpisovalcev, ki ni le posledica nepoznavanja, je skupina CMDh menila naslednje:
The CMDh finally encouraged the integration of the training activities abovementioned in the continuing medical education at national level.
Skupina CMDh je tudi spodbudila vključevanje zgoraj navedenih aktivnosti usposabljanja v stalno medicinsko izobraževanje na nacionalni ravni.
The CMDh through its representatives of NCAs have further discussed the national specificities of the healthcare systems and was of the view that the proposed controlled access program is likely to be feasible for the following reasons:
Skupina CMDh je prek svojih predstavnikov iz nacionalnih pristojnih organov nadalje razpravljala o nacionalnih posebnostih zdravstvenih sistemov in menila, da bi bil predlagani program nadzorovanega dostopa izvedljiv, in sicer zaradi naslednjih razlogov:
Therefore, the PRAC recommends the suspension of the marketing authorisations for all medicinal products referred to in Annex I.
Zato priporoča začasni umik dovoljenj za promet z vsemi zdravili, navedenimi v Prilogi I.
It should also be noted that the ultimate benefit expected from HES solutions for infusion (and treatment of hypovolemia in general) is a reduction of mortality and lower incidence of renal failure.
Opozoriti je treba tudi, da je končna korist, pričakovana od raztopin HES za infundiranje (in od zdravljenja hipovolemije na splošno), zmanjšanje umrljivosti in manjša pojavnost ledvične odpovedi.
The protocol should also include a measure of the primary outcomes at baseline.
Protokol mora vključevati tudi merilo primarnih izidov ob izhodišču.
Results from two drug utilisation studies, submitted by the concerned Marketing Authorisation Holders (‘MAHs') in 2017, have shown that the recommended restrictions in use are not being sufficiently adhered to.
Rezultati dveh študij o uporabi zdravil, ki so ju predložili zadevni imetniki dovoljenj za promet z zdravilom leta 2017, kažejo, da se priporočene omejitve uporabe ne upoštevajo v zadostni meri.
• The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 107i of Directive 2001/83/EC, for hydroxyethyl starch (HES) solution for infusion (see Annex I).
• Odbor za oceno tveganja na področju farmakovigilance (PRAC) je obravnaval postopek v skladu s členom 107i Direktive 2001/83/ES za raztopino hidroksietil škroba (HES) za infundiranje (glejte Prilogo I);
The PRAC considered that despite arguments raised by some Member States, the potential for unmet medical need is not established.
Odbor PRAC je kljub argumentom, ki so jih navedle nekatere države članice, ocenil, da potencial za neizpolnjene medicinske potrebe ni opredeljen.
A follow-up questionnaire to be filled after administration would not be effective in minimising the risk.
Kontrolni vprašalnik, ki bi ga bilo treba izpolniti po dajanju, pri zmanjševanju tveganja ne bi bil učinkovit.
This suggests that the previous communication measures although not sufficient to ensure full compliance, have had some effectiveness.
To kaže, da so predhodni ukrepi za obveščanje dosegli določeno učinkovitost, čeprav niso zadoščali za zagotavljanje popolnega upoštevanja.
Having considered the specificities of the national systems and the need for agreement with the national competent authorities on the details on the implementation of the controlled access and the time required to complete the adequate training to all HCPs intended to use HES products and the accreditation of the hospitals/ centres, the CMDh requested that the controlled access program should be effectively implemented at the latest 9 months after Commission Decision.
Z upoštevanjem posebnosti nacionalnih sistemov in potrebe po dogovoru z nacionalnimi pristojnimi organi glede podrobnosti izvajanja programa nadzorovanega dostopa in potrebnega časa za izvedbo ustreznega usposabljanja za vse zdravstvene delavce, ki naj bi uporabljali zdravila s HES, ter glede akreditacije bolnišnic/centrov, je skupina CMDh zahtevala, da mora biti program nadzorovanega dostopa učinkovito uveden najpozneje v devetih mesecih po sklepu Komisije.
See all contraindications in the SmPC.” The CMDh acknowledged that the prescribers would not often administer the solution and therefore could not see this warning label.
Za vse kontraindikacije glejte povzetek glavnih značilnosti zdravila.“ Skupina CMDh je priznala, da predpisovalci pogosto ne dajejo raztopine in zato te opozorilne oznake ne bi videli.
Treatment of hypovolemia should replace lost blood volume in order to restore tissue perfusion and oxygenation to ultimately prevent renal injury and death.
Pri zdravljenju hipovolemije je treba nadomestiti izgubljeni volumen krvi, da se obnovita perfuzija in oksigenacija tkiva in se tako v končni fazi preprečita ledvična poškodba in smrt.
Proposals to amend the indications and contraindications were not considered sufficient to have a significant impact on prescriber behaviour.
Predlogi za spreminjanje indikacij in kontraindikacij niso bili ocenjeni kot zadostni, da bi imeli pomemben vpliv na obnašanje predpisovalcev.
The CMDh also noted that treatment characteristics in some of the previously assessed clinical studies such as strength, dose or length of treatment may differ from current practice.
Skupina CMDh je upoštevala tudi, da se značilnosti zdravljenja v nekaterih predhodno ocenjenih kliničnih študijah, kot so jakost, odmerek ali dolžina zdravljenja, razlikujejo od trenutne prakse.
• This measure will ensure long term effectiveness through reminders sent to the trained HCPs and training of new ones.
• ta ukrep bo z opomniki, poslanimi usposobljenim zdravstvenim delavcem, in usposabljanji za nove zdravstvene delavce zagotovil dolgoročno učinkovitost.
The CMDh took also into consideration the responses to the questions raised by the European Commission and the elements collected by the PRAC, as well as the information provided by the MAH during the oral explanations held on 28 May 2018 and 25 June 2018.
Skupina CMDh je upoštevala tudi odgovore na vprašanja Evropske komisije in elemente, ki jih je zbral odbor PRAC ter informacije, ki so jih predložili imetniki dovoljenj za promet z zdravilom med ustno obrazložitvijo, ki je potekala 28. maja 2018 in 25. junija 2018.
It is proposed to mention explicitly in the new warnings ‘renal impairment' in addition to ‘sepsis' and ‘critically ill patients'; this would add further emphasis on this specific critically ill patients.
Predloga se, da se v novem opozorilu poleg „sepse“ in „kritično bolnih“ izrecno navede „ledvična okvara“, s čimer bi dodatno poudarili zlasti te kritično bolne bolnike.
The PRAC also reviewed responses from Member States in relation to the potential unmet medical need and proposals for additional risk minimisation measures.
Odbor PRAC je pregledal tudi odgovore držav članic v zvezi z morebitnimi neizpolnjenimi medicinskimi potrebami in predloge za dodatne ukrepe za zmanjšanje tveganja;
The CMDh acknowledged the complexity of managing patient suffering from hypovolemia due to an acute blood loss, and the fact that these patients require an individual evaluation.
Skupina CMDh je priznala, da je obravnava bolnikov s hipovolemijo kompleksna, in sicer zaradi akutne izgube krvi in dejstva, da ti bolniki potrebujejo posamično ovrednotenje.
The CMDh considered also the divergence of positions of the learned societies in the EU.
Skupina CMDh je preučila tudi razhajanja v stališčih strokovnih združenj v EU.
In addition, a significant decrease of the usage of HES solutions for infusion was noted in most EU Member States.
Poleg tega so v večini držav članic opazili pomembno zmanjšanje uporabe raztopin HES za infundiranje.
There is a direct relation between the degree of hypovolemia and the risk for renal injury and death.
Obstaja neposredna povezava med stopnjo hipovolemije in tveganjem za ledvično poškodbo in smrt.
The CMDh took into consideration all the new elements available since the previous CMDh position.
Skupina CMDh je upoštevala vse nove elemente, na voljo od njenega zadnjega stališča.
• The assumption that the non-adherence is not only due to lack of awareness is not supported by sufficient evidence and might not be representative of a significant portion of the prescribers population.
• domneva, da neupoštevanje ni le posledica nepoznavanja, ni podprta z zadostnimi dokazi in morda ni reprezentativna za velik delež populacije predpisovalcev;
The PRAC have also further considered for the feasibility and likely effectiveness of risk minimisation measures.
Odbor PRAC je nadalje preučil tudi izvedljivost in verjetno učinkovitost ukrepov za zmanjšanje tveganja.
• In view of the seriousness of the risks related to the use of HES solutions for infusion outside the terms of the MA, the CMDh considered this measure as proportionate.
• glede na resnost tveganj, povezanih z uporabo raztopin HES za infundiranje zunaj pogojev dovoljenja za promet z zdravilom, je skupina CMDh ta ukrep ocenila za sorazmernega.