FrancophonIA/ELRC3.0 huggingface dataset:
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis,
Slovenian: Zdravilo Kromeya je namenjeno za zdravljenje naslednjih vnetnih bolezni: - revmatoidni artritis, - poliartikularni juvenilni idiopatski artritis, - artritis, povezan z entezitisom, - ankilozirajoči spondilitis, - aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis, - psoriatični artritis, - luskavica (psoriaza), - Crohnova bolezen, - ulcerozni kolitis in - neinfekcijski uveitis.
English: Your doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Slovenian: Zdravnik lahko predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
English: Table 20: Paediatric plaque psoriasis efficacy results at 16 weeks MTX
Slovenian: Preglednica 20: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
English: If these medicines do not work well enough, your child will be given Kromeya to reduce the signs and symptoms of his/her disease.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok dobil zdravilo Kromeya za zmanjšanje znakov in simptomov Crohnove bolezni.
English: Kromeya 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Kromeya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
English: Children and adolescents from 2 years of age weighing 30 kg or more
Slovenian: Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več
English: RA Study III a**
Slovenian: Študija revmatoidnega artritisa a**
English: • pull the pre-filled pen straight up and out of the packaging (Figure D).
Slovenian: • injekcijski peresnik potegnite navzgor iz škatle (Slika D).
English: Step 3 Check the Syringe
Slovenian: 3. korak Preglejte injekcijsko brizgo
English: • Store the pre-filled pen in its original box to protect it from light.
Slovenian: • Napolnjeno brizgo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: PsA study II with 12 -week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Slovenian: V njej so zdravili 100 bolnikov, ki se niso ustrezno odzvali na imunomodulirajočo terapijo.
English: 5.1 Wipe the skin of your injection site with an alcohol pad to clean it (Figure K).
Slovenian: 5.1 Koţo na mestu injiciranja obrišite z zloţencem, prepojenim z alkoholom, da jo očistite.
English: Kromeya is available as a vial, a pre-filled syringe and a pre-filled pen.
Slovenian: Zdravilo Kromeya je na voljo v viali, napolnjeni injekcijski brizgi in napolnjenem injekcijskem peresniku.
English: Your child's doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Slovenian: Otrokov zdravnik lahko predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
English: Note: P = Placebo (Number at Risk); A = Adalimumab (Number at Risk).
Slovenian: Opomba: P = placebo (število rizičnih preiskovancev); A = Adalimumab (število rizičnih preiskovancev).
English: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Slovenian: Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija z adalimumabom in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0,001) in monoterapije z adalimumabom (p < 0,001).
English: Read carefully these entire instructions before using your Kromeya pre-filled syringe.
Slovenian: Pred uporabo zdravila Kromeya napolnjena injekcijska brizga natančno preberite celotno navodilo.
English: Week 12 Week 24 ASAS 50 Week 2
Slovenian: 2. teden 12. teden 24. teden ASAS 50 2. teden 12. teden 24. teden ASAS 70 2. teden 12. teden 24. teden
English: • facial oedema (swelling);
Slovenian: • edem obraza (oteklina);
English: Table 25 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission
Slovenian: Preglednica 25 Študija Crohnove bolezni pri pediatričnih bolnikih Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule Standardni odmerek 40/20 mg vsak drugi teden
English: If this dose does not work well enough, your doctor may increase the dose frequency to 40 mg every week or 80 mg every other week.
Slovenian: Če ta odmerek ne bo deloval dovolj dobro, lahko zdravnik poveča odmerek na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Discontinuation of Kromeya therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom Kromeya.
English: RA study III a**
Slovenian: Študija revmatoidnega artritisa III a**
English: Table 21 Induction of clinical remission and response (percent of patients)
Slovenian: Preglednica 21: Indukcija klinične remisije in odziva (odstotek bolnikov)
English: ACR 20 Week 12 Week 24
Slovenian: > 32 tednov 20 tednov > 32 tednov
English: • Only use Kromeya Vial Kit if your healthcare professional has trained you how to use it correctly.
Slovenian: • Zdravilo Kromeya komplet z vialo lahko uporabljate le, če vas je zdravstveni delavec naučil,
English: RA Study II a**
Slovenian: Študija revmatoidnega artritisa II a**
English: 3.2 Check the label to make sure that:
Slovenian: 3.2 Preverite nalepko, ali:
English: Kromeya is administered via subcutaneous injection.
Slovenian: Zdravilo Kromeya se odmerja v obliki subkutane injekcije.
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Slovenian: Pri bolnikih, ki so dobivali adalimumab, so opaţali oportunistične okuţbe, vključno z invazivnimi glivičnimi okuţbami.
English: Transparent syringe housing
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Low dose 20/10 mg eow p value
Slovenian: Nizek odmerek 20/10 mg vsak drugi teden p vrednost
English: Check with your doctor before your child receives any vaccines.
Slovenian: Preden vaš otrok opravi kakršno koli cepljenje, se posvetujte z zdravnikom.
English: 2.5 Wipe the entire vial top with an alcohol pad and throw the pad away.
Slovenian: 2.5 Očistite površino pod pokrovčkom z zloţencem, prepojenim z alkoholom, ki ga nato zavrţete.
English: Phase
Slovenian: Masa
English: Adalimumab 40 mg eow N=109
Slovenian: Adalimumab 40 mg vsak drugi teden N = 109
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Slovenian: Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekcija v enem dnevu).
English: Your child's doctor may prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Slovenian: Otrokov zdravnik lahko predpiše začetni odmerek 80 mg, ki se ga uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
English: a p Value b
Slovenian: vrednost p
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neţelenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: • Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
Slovenian: • Zdravniku povejte, če je vaš otrok imel v preteklosti ponavljajoče se okuţbe ali druge bolezni,
English: NA
Slovenian: Po
English: • Do not shake.
Slovenian: • ne pušča,
English: Refer to Storage information for -how to store your unused syringe(s).
Slovenian: Za navodila za shranjevanje neuporabljene injekcijske brizge (neuporabljenih injekcijskih brizg) glejte poglavje Navodila za shranjevanje.
English: Warning: Do not remove the clear needle cap.
Slovenian: Opozorilo: Ne odstranite prozornega pokrovčka na igli.
English: It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems.
Slovenian: Pomembno je, da zdravniku poveste, če vaš otrok doţivi simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali teţave z zobmi.
English: CD study I: infliximab naive patients
Slovenian: Študija pri Crohnovi bolezni I: Bolniki, ki še niso dobivali infliksimaba
English: Table 22 Maintenance of clinical remission and response (percent of patients)
Slovenian: Preglednica 22: Vzdrţevanje klinične remisije in odziva (odstotek bolnikov)
English: Table 13: Paediatric plaque psoriasis efficacy results at 16 weeks MTX
Slovenian: Preglednica 14: Študija pri psoriazi I (REVEAL) Rezultati učinkovitosti po 16 tednih Adalimumab placebo
English: Warning: Do not touch the vial adapter.
Slovenian: Opozorilo: Nastavka za vialo se ne dotikajte.
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I − V. In these trials, 11.9% of patients treated with adalimumab and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Slovenian: V teh preskušanjih so pozitivne titre protijedrnih protiteles po 24 tednih ugotovili pri 11,9 % prejemnikov adalimumaba in 8,1 % prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
English: Ankylosing Spondylitis Disease Activity Score
Slovenian: ASDAS = ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease Activity Score)
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more
Slovenian: Otroci in mladostniki, starejši od 6 let, ki tehtajo 30 kg ali več
English: 6.1 With the other hand, gently pinch a fold of cleaned skin and maintain it.
Slovenian: 6.1 Z drugo roko neţno naredite koţno gubo in jo drţite.
English: • Keep the Kromeya pre-filled pen out of the reach of children.
Slovenian: • Zdravilo Kromeya napolnjen injekcijski peresnik shranjujte nedosegljivo otrokom.
English: • 80 mg at week 0 and 40 mg at week 2
Slovenian: • 80 mg v 0. tednu in 40 mg v 2. tednu ≥ 40 kg • 80 mg v 0. tednu in 40 mg v 2. tednu
English: How to store Kromeya
Slovenian: Shranjevanje zdravila Kromeya
English: Treatment with Kromeya must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Slovenian: Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje z zdravilom Kromeya prekiniti.
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline PGA score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Slovenian: V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 18,9, izhodiščna zdravnikova globalna ocena PGA pa je segala od "zmerne" (53 % vključenih preiskovancev) do "hude" (41 %) in "zelo hude" (6 %).
English: Paediatric plaque psoriasis Age or body weight
Slovenian: Pediatrična luskavica v plakih Starost ali telesna masa
English: p-value
Slovenian: P vrednost
English: • skin cancer;
Slovenian: • koţni rak;
English: Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Slovenian: Ena 0,8 ml enoodmerna napolnjena injekcijska brizga vsebuje 40 mg adalimumaba.
English: It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.
Slovenian: Pomembno je, da zdravniku poveste, če doţivite simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali teţave z zobmi.
English: Warning: Do not use the syringe if there is a large amount of air in the syringe.
Slovenian: Opozorilo: Če je v injekcijski brizgi večja količina zraka, je ne smete uporabiti.
English: Kromeya 40 mg solution for injection in pre-filled syringe
Slovenian: Kromeya 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Idiopathic thrombocytopenic purpura
Slovenian: Adalimumab placebo metotreksat
English: • If needed, for example when traveling, a single pre-filled syringe can be stored at room temperature for up to 14 days.
Slovenian: • Po potrebi lahko posamezno napolnjeno injekcijsko brizgo shranjujete pri sobni temperaturi do
English: 4.1 Peel open the needle packaging to uncover the yellow syringe connector.
Slovenian: 4.1 Odprite ovojnino in jo odstranite z rumenega konektorja za injekcijsko brizgo.
English: • trouble breathing, swallowing;
Slovenian: • teţave pri dihanju, poţiranju;
English: Table 19 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission
Slovenian: Preglednica 19 Študija Crohnove bolezni pri pediatričnih bolnikih Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule Standardni odmerek 40/20 mg vsak drugi teden
English: Table 21 Maintenance of clinical remission and response (percent of patients)
Slovenian: Preglednica 21 Vzdrţevanje klinične remisije in odziv (Odstotek bolnikov)
English: • liver failure;
Slovenian: • teţave z ledvicami;
English: Not known
Slovenian: • ne pušča
English: Adalimumab 0.8 mg/kg eow N=38
Slovenian: Adalimumab 0,8 mg/kg vsak drugi teden N = 38
English: Hypertension, flushing, haematoma
Slovenian: Ţilne bolezni pogosti hipertenzija, zardevanje, hematom,
English: Initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days),
Slovenian: Začetni odmerek je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) nato sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
English: Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
Slovenian: Če se bolnik med tem obdobjem ne odzove, je pred podaljšanjem zdravljenja na več kot 16 tednov potreben natančen ponoven razmislek.
English: Warning: Do not use the vial if the liquid is cloudy, colored or has particles or flakes in it. 2.4 Gently remove the yellow cap from the vial.
Slovenian: Opozorilo: Vialo ne uporabljajte, če je tekočina motna ali obarvana ali če vsebuje delce ali kosmiče.
English: Warning: Do not recap the pre-filled pen.
Slovenian: Opozorilo: Pokrovčka ne natikajte ponovno na napolnjen injekcijski peresnik.
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Slovenian: Pediatrični bolniki z zmerno do hudo Crohnovo boleznijo so odvisno od njihove telesne mase (več ali manj od 40 kg) dobivali odprt začetni odmerek adalimumaba 160/80 mg v 0. tednu in 80/40 mg v 2. tednu.
English: Injector body
Slovenian: Tulec Injekcijska brizga
English: • the injection site
Slovenian: • mestu injiciranja,
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Slovenian: Pomembno je, da poveste svojemu zdravniku, če dobite znake okuţbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
English: Clinical remission 12% 24% 36%*
Slovenian: 24. teden 15 % 57 %***
English: Talk to your child's doctor or pharmacist before using Kromeya
Slovenian: Pred začetkom uporabe zdravila Kromeya se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: Warning: Do not twist the cap.
Slovenian: Opozorilo: Pokrovčka ne vrtite.
English: • Hold the syringe like a pencil.
Slovenian: • Injekcijsko brizgo drţite tako kot pisalo.
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Mannitol
Slovenian: 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
English: Note: P = Placebo (number at risk (flared)); A = Adalimumab (number at risk (flared)).
Slovenian: Opomba: P = Placebo (število rizičnih preiskovancev (zagon bolezni)); A = Adalimumab (število rizičnih preiskovancev (zagon bolezni)).
English: Do not try to reinsert it and use a new kit.
Slovenian: Uporabite nov komplet.
English: 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.
Slovenian: 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.
English: Alcohol pads
Slovenian: Zloţenec prepojen z alkoholom
English: Needle Guard Spring
Slovenian: Zapora tankega črevesa
English: Talk to your doctor or pharmacist before using Kromeya
Slovenian: Pred začetkom uporabe zdravila Kromeya se posvetujte z zdravnikom ali farmacevtom.
English: 1.7 Leave the pre-filled pen at room temperature for at least 30 minutes to allow the medicine to warm up (Figure F).
Slovenian: 1.7 Injekcijski peresnik pustite na sobni temperaturi 30 minut, da se zdravilo ogreje.
English: 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.
Slovenian: V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m
English: • You might get infections more easily while you are receiving Kromeya treatment.
Slovenian: • Med zdravljenjem z zdravilom Kromeya se lahko poveča dovzetnost za okuţbe.
English: • psoriasis,
Slovenian: • luskavica (psoriaza),
English: Common
Slovenian: Konica
English: • If needed, for example when traveling, a single pre-filled pen can be stored at room temperature for up to 14 days.
Slovenian: • Po potrebi lahko posamezen napolnjen injekcijski peresnik shranjujete pri sobni temperaturi do
English: Intestinal perforation
Slovenian: Zaviranje vnetja
English: d score methotrexate
Slovenian: NALEPKA NA BRIZGI
English: • eye inflammation;
Slovenian: • okuţba očesa;
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
Slovenian: 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**,
English: Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Slovenian: En 0,8 ml enoodmerni napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba.
English: • paediatric uveitis
Slovenian: • uveitis pri pediatrični populaciji
English: • stroke;
Slovenian: • vnetja.
English: Vascular disorders
Slovenian: Simptomi okuţbe
English: Step 6 Give your Injection
Slovenian: 7. korak Zavrzite injekcijski peresnik
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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 %.
English: • Lift the pre-filled pen from your skin (Figure Q).
Slovenian: • Injekcijski peresnik odmaknite od koţe (Slika Q).
English: • hearing loss, buzzing;
Slovenian: • izguba sluha, šumenje v ušesih;
English: confidence interval)
Slovenian: Deleţ (95 % interval zaupanja)
English: Therefore, the combination of adalimumab and anakinra is not recommended.
Slovenian: Zato kombinacija adalimumaba in anakinre ni priporočljiva (glejte poglavje 4.5).
English: every week or 80 mg every other week.
Slovenian: 20 mg vsak drugi teden 40 mg vsak drugi teden
English: Kromeya 40 mg solution for injection in pre-filled pen
Slovenian: Kromeya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: 6.3 Insert the needle
Slovenian: 6.3 Injiciranje
English: Liver failure
Slovenian: Nastavek za vialo
English: What you need to know before your child uses Kromeya
Slovenian: 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
English: Induction dose
Slovenian: občasni diplopija
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Slovenian: Farmacevtska oblika Pot uporabe
English: EU Number
Slovenian: Številka EU dovoljenja za promet
English: Content
Slovenian: Stična ovojnina
English: The primary outcomes should be common to all studied EU Member States.
Slovenian: Primarni izidi morajo biti skupni za vse preučevane države članice EU.
English: The effectiveness of this measure should be considered in combination with other measures.
Slovenian: Učinkovitost tega ukrepa je treba obravnavati skupaj z drugimi ukrepi;
English: Hence:
Slovenian: Torej:
English: These include drug utilisation data from 11 EU Member States.
Slovenian: Vključevali so podatke o uporabi zdravil iz 11 držav članic EU.
English: Protocols should include a representative sample of EU Member States.
Slovenian: Protokoli morajo vključevati reprezentativen vzorec držav članic EU.
English: These views often reflected the current national medical practice and the debate in the medical community.
Slovenian: Ta stališča so pogosto odražala trenutne nacionalne medicinske prakse in razpravo v medicinski skupnosti.
English: This includes recordings of trainings and accreditation.
Slovenian: To vključuje tudi evidence usposabljanj in akreditacije.
English: However, this measure should be seen as part of the complete program of risk minimisation measures.
Slovenian: Vendar je treba ta ukrep obravnavati kot del celovitega programa ukrepov za zmanjšanje tveganja.
English: • Proposals for additional risk minimisation measures and pharmacovigilance activities
Slovenian: • Predlogi za dodatne ukrepe za zmanjšanje tveganja in farmakovigilančne aktivnosti
English: The frequency of the training / reminders should be discussed at national level taking consideration particularities of each national healthcare system.
Slovenian: O pogostnosti usposabljanja/opomnikov se je treba dogovoriti na nacionalni ravni, in sicer z upoštevanjem posebnosti zdravstvenega sistema posamezne države;
English: The PRAC discussed the above two points at its May meeting, taking into consideration information provided by the Member States.
Slovenian: Odbor PRAC je razpravljal o zgornjih dveh točkah na svojem majskem sestanku in upošteval informacije, ki so jih predložile države članice.