FrancophonIA/ELRC3.0 huggingface dataset:
English: Ilaris 150 mg powder for solution for injection
Slovenian: Ilaris 150 mg prašek za raztopino za injiciranje
English: Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).
Slovenian: Zdravilo Ilaris je indicirano za zdravljenje sindroma hiperglobulinemije D (HIDS)/pomanjkanja mevalonat kinaze (MKD).
English: What Ilaris contains
Slovenian: Kaj vsebuje zdravilo Ilaris
English: Do not try to heat the vial.
Slovenian: Viale ne poskušajte segrevati.
English: If a satisfactory clinical response has not been achieved 7 days after treatment start, a second dose of canakinumab at 150 mg or 2 mg/kg can be considered.
Slovenian: Če pri bolnikih 7 dni po začetku zdravljenja ne pride do zadovoljivega kliničnega odziva, razmislite o uporabi drugega odmerka 150 mg oziroma 2 mg/kg kanakinumaba.
English: There were 80 paediatric CAPS patients (2-17 years of age) who received canakinumab in the interventional studies.
Slovenian: V intervencijskih študijah je kanakinumab prejemalo 80 pediatričnih bolnikov s CAPS (starih 2-17 let).
English: If a full treatment response is subsequently achieved, the intensified dosing regimen of 300 mg or 4 mg/kg every 8 weeks should be maintained.
Slovenian: Če po drugem odmerku zdravila pride do popolnega odziva na zdravljenje, je potrebno vzdrževati intenzivnejši režim odmerjanja s 300 mg oziroma 4 mg/kg vsakih 8 tednov.
English: One vial contains 150 mg canakinumab in 1 ml of solution.
Slovenian: Ena viala vsebuje 150 mg kanakinumaba v 1 ml raztopine.
English: Read all the way through these instructions before injecting.
Slovenian: Preden začnete z injiciranjem, preberite ta navodila v celoti.
English: Safely dispose of needles and syringe in the sharps container or as directed by your healthcare provider or pharmacist.
Slovenian: Igle in brizge previdno zavrzite v zbiralnik za ostre predmete oziroma tako, kot vam je naročil usposobljen zdravstveni delavec ali farmacevt.
English: The expression of hepatic CYP450 enzymes may be suppressed by the cytokines that stimulate chronic inflammation, such as interleukin-1 beta (IL-1 beta).
Slovenian: Citokini, ki spodbujajo kronično vnetje, na primer interlevkin-1 beta (IL-1 beta), lahko zavirajo izražanje jetrnih encimov s CYP450.
English: - Any unused medicine must be discarded after withdrawal of the dose.
Slovenian: - Morebiten ostanek zdravila je treba zavreči takoj po tem, ko iz viale vzamete ustrezen odmerek.
English: The other ingredients are mannitol, histidine, histidine hydrochloride monohydrate, polysorbate 80, water for injections.
Slovenian: Druge sestavine zdravila so: manitol, histidin, histidinijev klorid monohidrat, polisorbat 80, voda za injekcije.
English: Ilaris 150 mg powder for solution for injection is supplied in a single-use vial for individual use.
Slovenian: Ilaris 150 mg prašek za raztopino za injiciranje je na voljo v viali za enkratno uporabo za posameznega bolnika.
English: Your doctor will discuss with you the potential risks of taking Ilaris before breast-feeding.
Slovenian: Zdravnik vam bo razložil možna tveganja uporabe zdravila, preden začnete dojiti.
English: Pharmacokinetic properties are similar in CAPS, TRAPS, HIDS/MKD, FMF and SJIA paediatric populations.
Slovenian: Farmakokinetične lastnosti zdravila so v populacijah pediatričnih bolnikov s CAPS, s sindromi TRAPS, HIDS/MKD ali FMF oziroma s SJIA podobne.
English: What Ilaris is
Slovenian: Kaj je zdravilo Ilaris
English: Continued treatment with canakinumab in patients without clinical improvement should be reconsidered by the treating physician.
Slovenian: Pri bolnikih, pri katerih ne pride do kliničnega izboljšanja, mora lečeči zdravnik pretehtati smiselnost nadaljnjega zdravljenja s kanakinumabom.
English: The safety profile in AOSD patients is expected to be similar to SJIA patients based on literature reports.
Slovenian: Po podatkih poročil iz literature je pri bolnikih s Stillovo boleznijo z začetkom v odrasli dobi (AOSD) mogoče pričakovati podoben varnostni profil kot pri bolnikih s SJIA.
English: Additional dose of 4 mg/kg can be considered
Slovenian: Razmislite o uporabi dodatnega odmerka 4 mg/kg
English: Mixing Ilaris
Slovenian: Mešanje zdravila Ilaris
English: Properly dispose of vials containing remaining Ilaris solution (if any) as directed by your healthcare provider or pharmacist.
Slovenian: Viale, ki lahko vsebujejo nekaj raztopine zdravila Ilaris, ustrezno zavrzite, kot vam je naročil usposobljen zdravstveni delavec ali farmacevt.
English: Additional dose of 2 mg/kg can be considered
Slovenian: Razmislite o uporabi dodatnega odmerka 2 mg/kg
English: Histidine hydrochloride monohydrate Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi saharoza histidin histidinijev klorid monohidrat polisorbat 80
English: Ilaris 150 mg/ml solution for injection
Slovenian: Ilaris 150 mg/ml raztopina za injiciranje
English: TRAPS, HIDS/MKD and FMF patients with body weight > 40 kg
Slovenian: Bolniki s sindromom TRAPS, HIDS/MKD ali FMFin z > 40 kg
English: Efficacy and safety of canakinumab in young adult SJIA patients aged 16 to 20 years were consistent with the efficacy and safety observed for patients less than 16 years of age.
Slovenian: Pri mladih odraslih bolnikih s SJIA, ki so bili stari od 16 do 20 let, sta bili učinkovitost in varnost kanakinumaba podobni kot pri tistih bolnikih, ki so bili stari manj kot 16 let.
English: A 56-week, open-label study was conducted to assess the efficacy, safety and tolerability of canakinumab in paediatric CAPS patients ≤ 4 years of age.
Slovenian: Za oceno učinkovitosti, varnosti in prenašanja kanakinumaba pri pediatričnih bolnikih s CAPS, ki so stari 4 leta ali manj, so izvedli 56-tedensko odprto študijo.
English: One vial contains 150 mg of canakinumab*.
Slovenian: Ena viala vsebuje 150 mg kanakinumaba*.
English: Ilaris 150 mg powder for solution for injection canakinumab
Slovenian: Ilaris 150 mg prašek za raztopino za injiciranje kanakinumab
English: No change in pharmacokinetic parameters based on clearance or volume of distribution were observed between elderly patients and adult patients < 65 years of age.
Slovenian: Med starejšimi bolniki in odraslimi bolniki, starimi manj kot 65 let, niso opažali razlik v farmakokinetičnih parametrih na osnovi opazovanja očistka in volumna porazdelitve.
English: After reconstitution, each ml of solution contains 150 mg canakinumab.
Slovenian: Po rekonstituciji en mililiter raztopine vsebuje 150 mg kanakinumaba.
English: Ilaris treatment may give you a spinning sensation (dizziness or vertigo) or intense tiredness (asthenia).
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pri zdravljenju z zdravilom Ilaris lahko pride do občutka, da se vam vrti (omotičnost ali vrtoglavica) ali do hude utrujenosti (do pomanjkanja moči in energije).
English: Carefully remove the cap from the transfer needle and set the cap aside.
Slovenian: Previdno odstranite pokrovček z igle za prenos in ga odložite.
English: Remove the caps from the Ilaris and water vials.
Slovenian: Z vial z zdravilom Ilaris in z vodo odstranite zaščitni zaporki.
English: Clean the rubber stopper of the vial with an alcohol swab.
Slovenian: Gumijast zamašek na viali očistite z alkoholno blazinico.
English: Apparent clearance per kg body weight (CL/F per kg) was comparable between the SJIA and CAPS population (0.004 l/d per kg).
Slovenian: Vrednost navideznega očistka na kg telesne mase (CL/F na kg) je v populaciji bolnikov s SJIA podobna kot v populaciji bolnikov s CAPS (0,004 l/dan na kg).
English: The solution should be free of visible particles and clear to opalescent.
Slovenian: Raztopina mora biti bistra do opalescentna in ne sme vsebovati vidnih delcev.
English: Also contains: sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80.
Slovenian: Vsebuje tudi: saharozo, histidin, histidinijev klorid monohidrat, polisorbat 80.
English: - After mixing (reconstitution) the medicine should be used immediately.
Slovenian: Zdravilo je treba uporabiti takoj po tem, ko ga zmešate (po rekonstituciji).
English: Two non-randomised HIDS/MKD patients aged > 28 days but < 2 years were included in the study and received canakinumab.
Slovenian: V študijo sta bila vključena dva nerandomizirana bolnika, ki sta imela sindrom HIDS/MKD in sta bila stara več kot 28 dni, a manj kot 2 leti.
English: Open the wrappers containing the syringe and the withdrawal needle.
Slovenian: Odprite zavoja z brizgo in z iglo za izvlek.
English: Instructions for administration
Slovenian: Navodila za apliciranje
English: - Tumour necrosis factor receptor associated periodic syndrome (TRAPS) - Hyperimmunoglobulin D syndrome (HIDS) also known as mevalonate kinase deficiency (MKD) - Familial Mediterranean fever (FMF): Ilaris is used to treat FMF.
Slovenian: • huda oblika familiarnega avtoinflamatornega sindroma zaradi mraza (angleško familial cold autoinflammatory syndrome - FCAS) / familiarne urtikarije na mraz (angleško familial cold urticaria - FCU), pri kateri znaki in simptomi presegajo tiste pri urtikariji, ki jo povzroča izpostavljenost mrazu, - periodični sindrom povezan z receptorjem za tumorje nektrotizirajoči faktor (TNF) s kratico TRAPS), - sindrom hiperglobulinemije D s kratico HIDS, ki ga imenujemo tudi pomanjkanje mevalonat kinaze s kratico MKD, - družinska mediteranska vročica s kratico FMF: zdravilo Ilaris uporabljamo za zdravljenje FMF.
English: - If not used immediately after mixing, the solution should be stored in the refrigerator
Slovenian: - Če raztopine ne uporabite takoj po mešanju,
English: There were 102 TRAPS, HIDS/MKD and FMF patients (2-17 years of age) who received canakinumab in a 16-week study.
Slovenian: V 16-tedenski študiji sta kanakinumab prejemala 102 bolnika s sindromom TRAPS, HIDS/MKD ali FMF (stara 2-17 let).
English: Remove the transfer needle from the syringe.
Slovenian: Odstranite pokrovček z injekcijske igle.
English: Ilaris 150 mg/ml solution for injection canakinumab
Slovenian: Ilaris 150 mg/ml raztopina za injiciranje kanakinumab
English: TRAPS, HIDS/MKD and FMF
Slovenian: Sindromi TRAPS, HIDS/MKD in FMF
English: If a full treatment response is subsequently achieved, maintaining the intensified dosing regimen of 8 mg/kg every 8 weeks should be considered, based on individual clinical judgement.
Slovenian: Če po drugem odmerku zdravila pride do popolnega odziva na zdravljenje, je potrebno na podlagi individualne klinične presoje razmisliti o vzdrževanju intenzivnejšega režima odmerjanja z 8 mg/kg vsakih 8 tednov.
English: - If you respond well enough to this, your treatment will be continued with 300 mg or 4 mg/kg every 4 weeks.
Slovenian: - Če bo odziv na drugi odmerek dovolj dober, boste v nadaljevanju prejemali višji odmerek, in sicer 300 mg oziroma 4 mg/kg vsake 4 tedne.
English: Gently push the plunger all the way down until air is in the vial.
Slovenian: Nežno potisnite bat navzdol, tako da v vialo potisnete zrak.
English: Mean and median increases in alanine transaminase (ALT) of 3.0 U/l and 2.0 U/l, respectively, and in aspartate transaminase (AST) of 2.7 U/l and 2.0 U/l, respectively, from baseline to end of study were seen in the canakinumab-treated groups versus the triamcinolone acetonide-treated group(s), however the incidence of clinically significant changes (≥ 3 x the upper limit of normal) was greater for patients treated with triamcinolone acetonide (2.5% for both AST and ALT) compared with canakinumabtreated patients (1.6% for ALT and 0.8% for AST).
Slovenian: Pri tem pa je bila pogostnost klinično pomembnih sprememb (na vrednost, ki je bila enaka ali višja od 3-kratnika zgornje meje normalnih vrednosti) večja pri bolnikih, ki so prejemali triamcinolon acetonid (2,5 % tako za AST kot za ALT), v primerjavi z bolniki, ki so prejemali kanakinumab (1,6% za ALT in 0,8 % za AST).
English: Broken skin and areas which are bruised or covered by a rash should be avoided.
Slovenian: Izogibajte se predelom, kjer je koža poškodovana oziroma kjer je na koži modrica ali izpuščaj.
English: Hypersensitivity reactions with canakinumab therapy have been reported.
Slovenian: Pri zdravljenju s kanakinumabom so poročali o preobčutljivostnih reakcijah.
English: Powder for solution for injection.
Slovenian: prašek za raztopino za injiciranje 1 viala.
English: Common features of AOSD and SJIA include fever, rash, hepatosplenomegaly, lymphadenopathy, polyserositis and arthritis.
Slovenian: Med pogostimi znaki sistemskega juvenilnega idiopatskega artritisa in Stillove bolezni z začetkom v odrasli dobi so zvišana telesna temperatura, izpuščaj, hepatosplenomegalija, limfadenopatija, poliserozitis in artritis.
English: Do not use if particles are present in the solution.
Slovenian: Če so v raztopini prisotni delci, je ne uporabljajte.
English: Pull the plunger all the way down to the 1.0 ml mark, filling the syringe with air. Insert the needle into the water vial through the centre of the rubber stopper.
Slovenian: Potegnite bat brizge do oznake 1,0 ml, da se bo brizga napolnila z zrakom.
English: Pull the plunger of the syringe all the way down to the 1.0 ml mark, filling the syringe with air. Insert the syringe needle into the vial of Ilaris solution through the centre of the rubber stopper.
Slovenian: - Potisnite iglo za izvlek v vialo z raztopino zdravila Ilaris skozi osrednji del gumijastega zamaška.
English: Seventeen patients (including 6 patients under the age of 2 years) were evaluated, using weight-based starting doses of 2-8 mg/kg.
Slovenian: Uporabo zdravila z začetnim odmerjanjem od 2 do 8 mg/kg glede na telesno maso so ocenjevali pri sedemnajstih bolnikih (med katerimi je bilo 6 bolnikov starih manj kot 2 leti).
English: CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA): You should continue using Ilaris for as long as the doctor tells you.
Slovenian: Kako dolgo je treba uporabljati zdravilo Ilaris Če imate katerega od sindromov CAPS, TRAPS, HIDS/MKD ali FMF ali Stillovo bolezen (AOSD ali SJIA): Zdravilo Ilaris uporabljajte tako dolgo, kot vam naroči zdravnik.
English: Ilaris 150 mg/ml injection canakinumab SC
Slovenian: Ilaris 150 mg/ml injekcija kanakinumab s.c. uporaba
English: Not included in the pack one 1.0 ml syringe one needle (such as 18 G or 21 G x 2 inch or similar, as available on the market) to draw up the solution from the vial (“withdrawal needle”).
Slovenian: Kar ni priloženo pakiranju eno brizgo 1,0 ml eno iglo (na primer velikosti 18 G ali 21 G x 2 palca ali podobno iglo, ki je na voljo na trgu) za izvlek raztopine iz viale ("iglo za izvlek") eno iglo 27 G x 0,5 palca (ali podobno iglo, ki je na voljo na trgu) za injiciranje ("injekcijsko iglo") alkoholne blazinice čiste suhe bombažne zložence adhezivni obliž ustrezen zabojnik za uporabljene igle, brizge in viale (zbiralnik za ostre predmete)
English: Bioavailability in TRAPS, HIDS/MKD and FMF patients has not been determined independently.
Slovenian: Pri bolnikih s sindromi TRAPS, HIDS/MKD ali FMF niso posebej določali biološke uporabnosti kanakinumaba.
English: Do not rub the injection area.
Slovenian: Ne brišite mesta, kamor ste injicirali zdravilo.
English: Recap the transfer needle as instructed by your healthcare provider or pharmacist.
Slovenian: Iglo za prenos spet pokrijte s pokrovčkom, kot vas je naučil usposobljen zdravstveni delavec ali farmacevt.
English: How to store Ilaris
Slovenian: Shranjevanje zdravila Ilaris
English: One vial contains 150 mg canakinumab.
Slovenian: Ena viala vsebuje 150 mg kanakinumaba.
English: UNIT PACK CARTON
Slovenian: ŠKATLA ZA POSAMIČNO PAKIRANJE
English: The expected accumulation ratio was 1.3-fold following 6 months of subcutaneous administration of 150 mg canakinumab every 8 weeks.
Slovenian: Po 6-mesečni subkutani uporabi 150 mg kanakinumaba vsakih 8 tednov je bilo pričakovano razmerje kopičenja 1,3.
English: No gender or age-related pharmacokinetic differences were observed after correction for body weight.
Slovenian: Po prilagajanju na telesno maso niso opažali nobenih razlik v farmakokinetičnih lastnostih, ki bi temeljile na spolu ali starosti bolnika.
English: One vial of powder contains 150 mg canakinumab.
Slovenian: Ena viala s praškom vsebuje 150 mg kanakinumaba.
English: If you respond well enough to the second dose, your treatment will be continued with 300 mg or 4 mg/kg every 8 weeks.
Slovenian: - Če bo odziv na drugi odmerek dovolj dober, boste v nadaljevanju prejemali višji odmerek, in sicer 300 mg oziroma 4 mg/kg vsakih 8 tednov.
English: If a full treatment response is subsequently achieved, maintaining the intensified dosing regimen of 600 mg or 8 mg/kg every 8 weeks should be considered, based on individual clinical judgement.
Slovenian: Če po tem odmerku zdravila pride do popolnega odziva na zdravljenje, je potrebno na podlagi individualne klinične presoje razmisliti o vzdrževanju intenzivnejšega režima odmerjanja s 600 mg oziroma 8 mg/kg vsakih 8 tednov.
English: Malignancies
Slovenian: Trombociti
English: If you have any questions, talk to your doctor, pharmacist or nurse.
Slovenian: Z morebitnimi vprašanji se obrnite na zdravnika, farmacevta ali medicinsko sestro.
English: Avoid touching the needles and the tops of the vials.
Slovenian: Pri rokovanju pazite, da se ne dotikate igle in vrha vial.
English: Immunogenicity
Slovenian: Injiciranje
English: • Respiratory infections such as chest infection, flu, sore throat, runny nose, blocked nose, sneezing, feeling of pressure or pain in the cheeks or forehead with or without fever (pneumonia, bronchitis, influenza, sinusitis, rhinitis, pharyngitis, tonsilitis, nasopharyngitis, upper respiratory tract infection).
Slovenian: Drugi neželeni učinki zdravila Ilaris so lahko: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): kakršnekoli okužbe, kar lahko vključuje: okužbe dihal, kot so okužba v prsnem košu, gripa, vnetje žrela, izcedek iz nosu, zamašen nos, kihanje, občutek pritiska ali bolečine v predelu lic in/ali čela z zvišano telesno temperaturo ali brez nje (pljučnica, bronhitis, gripa, sinusitis, nahod, vnetje žrela, vnetje tonzil (mandljev), nazofaringitis, okužba zgornjih dihal), druge okužbe, kot so okužba ušesa, okužba kože (flegmona), bolečine v želodcu in občutek slabosti (gastroenteritis) ter boleče in pogosto uriniranje z zvišano telesno temperaturo ali brez nje (okužba sečil), bolečine v zgornjem delu trebuha, bolečine v sklepih (artralgija), znižanje števila levkocitov (levkopenija), nenormalni izvidi testov ledvične funkcije (znižana vrednost ledvičnega očistka kreatinina, prisotnost beljakovin v urinu), reakcija na mestu injiciranja (kot so rdečina, oteklina, tolpota ali srbenje).
English: Insert the needle all the way into the vial until it reaches the bottom edge.
Slovenian: Iglo potisnite prav do dna viale.
English: It was estimated to be 0.17 l/d in a CAPS patient of body weight 70 kg and 0.11 l/d in a SJIA patient of body weight 33 kg. After accounting for body weight differences, no clinically significant differences in the pharmacokinetic properties of canakinumab were observed between CAPS and SJIA patients.
Slovenian: Njegova vrednost je ocenjena na 0,17 l/dan pri bolniku s CAPS, ki ima telesno maso 70 kg, in na 0,11 l/dan pri bolniku s SJIA, ki ima telesno maso 33 kg.
English: Uncap the transfer needle again.
Slovenian: Z igle za prenos spet odstranite pokrovček.
English: Recap the withdrawal needle as instructed by your healthcare provider or pharmacist.
Slovenian: Iglo za izvlek spet pokrijte s pokrovčkom, kot vas je naučil usposobljen zdravstveni delavec ali farmacevt.
English: Canakinumab should not be administered during an active infection.
Slovenian: V času aktivne okužbe bolnik ne sme prejemati kanakinumaba.
English: How much Ilaris to use Cryopyrin-associated periodic syndromes (CAPS) The recommended starting dose of Ilaris is: - Adults and children aged 4 years or more
Slovenian: Priporočeni začetni odmerek zdravila Ilaris je: - Odrasli in otroci, ki so stari najmanj 2 leti
English: Haematology
Slovenian: Hematološki izvidi
English: Gouty arthritis population
Slovenian: Populacija bolnikov z uričnim artritisom
English: CI p-value, 1-sided p < 0.0001*
Slovenian: razmerje ogroženosti za primerjavo z uporabo triamcinolon acetonida IZ vrednost p za enosmerni test p<0,0001*
English: - Take off the cap from the withdrawal needle.
Slovenian: - Odstranite pokrovček z igle za izvlek.
English: The expected accumulation ratio was 1.1-fold following subcutaneous administration of 150 mg canakinumab every 12 weeks.
Slovenian: Po subkutani uporabi 150 mg kanakinumaba vsakih 12 tednov je bilo pričakovano razmerje kopičenja
English: Increases in uric acid level (0.7 mg/dl at 12 weeks and 0.5 mg/dl at 24 weeks) were observed after canakinumab treatment in comparative trials in gouty arthritis.
Slovenian: V primerjalnih preskušanjih pri bolnikih z uričnim artritisom so po zdravljenju s kanakinumabom opažali zvišanje koncentracije sečne kisline (za 0,7 mg/dl po 12 tednih in za 0,5 mg/dl po 24 tednih).
English: The other ingredients are: sucrose, histidine, histidine hydrochloride monohydrate, polysorbate
Slovenian: Druge sestavine zdravila so: saharoza, histidin, histidinijev klorid monohidrat, polisorbat 80.
English: Place the transfer needle in the sharps container.
Slovenian: Iglo za prenos odstranite z brizge in jo zavrzite v zbiralnik za ostre predmete.
English: Each ml of solution contains 150 mg canakinumab.
Slovenian: En mililiter raztopine vsebuje 150 mg kanakinumaba.
English: A pro-inflammatory protein called IL-1 beta plays an important role in Still's disease inflammation.
Slovenian: Pri vnetju v okviru Stillove bolezni ima pomembno vlogo beljakovina, ki pospešuje vnetje (je provnetna) in se imenuje IL-1-beta.
English: Tumour necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial Mediterranean fever (FMF) The recommended starting dose of Ilaris is: - Adults and children aged 2 years or more
Slovenian: Periodični sindrom povezan z receptorjem za tumorje nekrotizirajoči faktor (TRAPS), sindrom hiperglobulinemije D (HIDS)/pomanjkanje mevalonat kinaze (MKD) in družinska mediteranska vročica (FMF)
English: In the overall SJIA programme, transient decreases in absolute neutrophil count (ANC) to less than 1 x 109/l were reported in 12 patients (6.0%).
Slovenian: V celotnem programu študij SJIA so o prehodnem znižanju absolutnega števila nevtrofilcev na manj kot 1 x 10
English: TRAPS, HIDS/MKD and FMF The efficacy and safety of canakinumab for the treatment of TRAPS, HIDS/MKD and FMF were demonstrated in a single, pivotal, phase III, 4-part study (N2301) consisting of three separate disease cohorts.
Slovenian: Sindromi TRAPS, HIDS/MKD in FMF Učinkovitost in varnost kanakinumaba pri zdravljenju sindromov TRAPS, HIDS/MKD in FMF so dokazovali v eni sami ključni študiji faze III (študiji N2301), ki je bila razdeljena na 4 obdobja in je vključevala tri ločene kohorte glede na vrsto bolezni: - 1. obdobje: bolniki, ki so bili stari 2 leti ali več, so v vsaki kohorti vstopili v 12-tedensko obdobje presejanja, v katerem so pri bolnikih ovrednotili nastop zagona bolezni; - 2. obdobje: ob nastopu zagona so bolnike randomizirali v 16-tedensko obdobje dvojno slepega, s placebom kontroliranega zdravljenja, v katerem so subkutano prejemali bodisi kanakinumab v odmerku 150 mg (oziroma 2 mg/kg pri bolnikih s telesno maso ≤ 40 kg) ali placebo vsake 4 tedne.
English: However, all other concerns remain.
Slovenian: Vendar pa Odbor ohranja vse ostale zadržke.
English: The applicant requested a reexamination of the opinion.
Slovenian: Vlagatelj je prosil za ponoven pregled podanega mnenja.
English: International non-proprietary name (INN): efungumab
Slovenian: Mednarodno nelastniško ime (INN): efungumab
English: Ref. EMEA/129723/2007
Slovenian: EMEA/129723/2007
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično preskušanje ali program sočutne uporabe in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.