FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/045
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/045
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/025
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/025
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 30.000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: Treatment with NeoRecormon is normally a long-term therapy.
Slovenian: Običajno je zdravljenje z zdravilom NeoRecormon dolgotrajno, vendar ga lahko kadar koli prekinemo, če je potrebno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/046
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/046
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 6000 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 6000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: · Do not reuse the same syringe.
Slovenian: • Pokrovčka igle na iglo ne nameščajte ponovno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/044
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/044
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/035
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/035
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/037
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/037
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 3000 IU injection epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE NeoRecormon 3000 i.e. injekcija epoetin beta i.v./s.c.uporaba
English: If you are donating your own blood before surgery, your doctor will need to: · check that you are capable of giving blood, especially if you weigh less than 50 kg · check that you have a sufficient level of red blood cells (haemoglobin of at least 11 g/dL) · make sure that only 12 % of your blood will be donated at once.
Slovenian: • preveriti, ali ste sposobni dati kri, še posebno, če tehtate manj kot 50 kg,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/042
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/042
English: · Do not leave the syringe unattended.
Slovenian: • Injekcijske brizge ne puščajte brez nadzora.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/026
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/026
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/043
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/043
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 10,000 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 10.000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/019
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/031/019
English: Roche (Hellas) A.E.
Slovenian: Roche s. r. o.
English: Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahyrate, Calcium chloride dihydrate, Glycine,
Slovenian: Sečnina, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat, kalcijev klorid dihidrat,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/033
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/033
English: 1 vial contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium chloride, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
Slovenian: SEZNAM POMOŽNIH SNOVI 1 viala vsebuje: sečnino, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, kalcijev klorid, glicin, L-levcin, L-izolevcin, L-treonin, L-glutaminsko kislino in Lfenilalanin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/029
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/029
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 3000 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 3000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/036
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/036
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/034
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/034
English: Treatment for increasing the amount of autologous blood The solution is administered intravenously over approx. 2 minutes or subcutaneously.
Slovenian: Pripravljeno raztopino dajemo intravensko približno 2 minuti ali subkutano.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/030
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/030
English: INFORMATION IN BRAILLE neorecormon 10.000 IU
Slovenian: neorecormon 10.000 i.e.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/041
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/041
English: INFORMATION IN BRAILLE neorecormon 5000 IU
Slovenian: neorecormon 5000 i.e.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/031
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/031
English: France
Slovenian: Nemčija
English: INFORMATION IN BRAILLE neorecormon 4000 IU
Slovenian: neorecormon 4000 i.e.
English: Treatment of symptomatic chemotherapy-induced anaemia in cancer patients NeoRecormon should be administered by the subcutaneous route to patients with anaemia (e.g.
Slovenian: Zdravljenje simptomatske anemije, nastale zaradi zdravljenja s kemoterapijo pri bolnikih z rakom
English: Breast-feeding
Slovenian: NALEPKE/AMPULA
English: In the lyophilisate: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium chloride, glycine, L-Leucine, L-Isoleucine, LThreonine, L-Glutamic acid, and L-Phenylalanine.
Slovenian: • Pomožne snovi so: v liofilizatu: sečnina, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, kalcijev klorid, glicin, L-levcin, L-izolevcin, L-treonin, L-glutaminska kislina in L-fenilalanin.
English: Do not increase the dose your doctor has given you.
Slovenian: Če ste injicirali prevelik odmerek zdravila NeoRecormon Odmerka, ki vam ga je predpisal zdravnik, ne povečujte.
English: · Keep this leaflet.
Slovenian: • Navodilo shranite.
English: Let it warm up on its own.
Slovenian: Pustite, da se ogreje sama.
English: Date of first authorisation: 23 October 2009 Date of latest renewal: 19 June 2014
Slovenian: Datum prve odobritve: 23. oktober 2009 Datum zadnjega podaljšanja: 19. junij 2014
English: Long term data from observational study
Slovenian: Dolgoročni podatki iz opazovalne študije
English: Please note that the preparation of the injection takes about 30 minutes.
Slovenian: Naj vas najprej opozorimo, da pripravljanje injekcije traja približno 30 minut.
English: You should then continue with injections at the recommended intervals as before.
Slovenian: Kasneje morate nadaljevati z injekcijami v priporočenih presledkih tako kot prej.
English: Allow to stand for 5 minutes.
Slovenian: Nato vialo pustite, da stoji 5 minut.
English: Your doctor may check your blood regularly if considered necessary.
Slovenian: Zdravnik vam bo morda redno pregledoval kri, če se mu bo zdelo potrebno.
English: Satisfactory clinical response after 7 days?
Slovenian: Zadovoljiv klinični odziv po 7 dneh?
English: Not to be sold separately.
Slovenian: Ni namenjena ločeni prodaji.
English: (There will be water remaining in the vial.)
Slovenian: (V viali bo ostalo nekaj vode.)
English: 1 In SJIA
Slovenian: 1 pri SJIA
English: This additional dose could be provided as early as 7 days after the first treatment dose.
Slovenian: Ta dodatni odmerek so lahko prejeli že 7 dni po prvem odmerku zdravila.
English: If you feel a spinning sensation or feel tired, do not drive or use any tools or machines until you are feeling normal again.
Slovenian: Če čutite vrtoglavico ali se počutite utrujeni, ne vozite avtomobila in ne uporabljajte nobenih naprav in strojev, dokler se ne počutite spet normalno.
English: Particularly in adult patients, this evaluation should include a detailed medical history.
Slovenian: Zlasti pri odraslih bolnikih mora tak pregled vključevati podrobno zdravstveno anamnezo.
English: Physician Global Assessment < 2
Slovenian: Zdravnikova splošna ocena < 2
English: More information on each of these diseases is given below.
Slovenian: Več podatkov o posamezni bolezni lahko najdete spodaj.
English: Two open-label, uncontrolled, long-term phase III studies were performed.
Slovenian: Izvedli so dve odprti nekontrolirani dolgoročni študiji faze III.
English: Centre de Biotechnologie 8, rue de l'Industrie 68330 Huningue France
Slovenian: Centre de Biotechnologie 8, rue de l'Industrie 68330 Huningue Francija
English: The total treatment duration ranged from 6 months to 2 years.
Slovenian: V celoti je zdravljenje trajalo od 6 mesecev do 2 let.
English: The clinical significance of this observation is unknown.
Slovenian: Klinični pomen te ugotovitve ni znan.
English: Your doctor may decide to delay or interrupt your treatment, but only if necessary.
Slovenian: Zdravnik bo morda odločil, da je treba zdravljenje odložiti ali prekiniti, vendar samo kadar bo to res potrebno.
English: The mean terminal half-life was 26 days.
Slovenian: Povprečni končni razpolovni čas je znašal 26 dni.
English: Steady state was reached after 110 days.
Slovenian: Do stanja dinamičnega ravnovesja je prišlo po 110 dneh.
English: It is important to tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby.
Slovenian: Pomembno je, da zdravniku poveste, če ste noseči, če mislite, da bi lahko bili noseči, ali če načrtujete zanositev.
English: Neutropenia and leukopenia
Slovenian: Nevtropenija in levkopenija
English: Do not stop taking Ilaris unless your doctor tells you to.
Slovenian: Zdravila Ilaris ne prenehajte jemati, razen če vam to naroči vaš zdravnik.
English: Frequency categories are defined 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); not known (cannot be estimated from the available data).
Slovenian: Skupine pogostnosti so opredeljene po naslednjem dogovoru: 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); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The mean number of gouty arthritis attacks in the previous 12 months was 6.5.
Slovenian: Povprečno število napadov uričnega artritisa v predhodnih 12 mesecih je bilo 6,5.
English: • Muckle-Wells syndrome (MWS),
Slovenian: • Muckle-Wellsov sindrom (MWS),
English: The studies were 12 weeks followed by 12-week double-blind extension.
Slovenian: Študiji sta trajali po 12 tednov, vsaka pa se je nadaljevala z 12-tedenskim dvojno slepim podaljšanjem študije.
English: Of the patients who had achieved a complete response, 89.3% maintained response without relapsing.
Slovenian: Med bolniki, pri katerih je prišlo do popolnega odziva, jih je 89,3 % ohranilo odziv brez ponovitve bolezni.
English: The terminal half-life ranged from 22.9 to 25.7 days, similar to the pharmacokinetic properties observed in adults.
Slovenian: Končni razpolovni čas je znašal od 22,9 do 25,7 dni, kar je podobno farmakokinetičnim lastnostim zdravila pri odraslih.
English: The efficacy observed in the studies G2305 and G2301 was maintained in the ongoing, open-label long-term extension study (data available through median of 49 weeks of follow-up).
Slovenian: Učinkovitost, ki so jo opažali v študijah G2305 in G2301, se ohranja v dolgoročnem odprtem podaljšanju študije, ki še poteka (na voljo so podatki po mediano 49 tednih spremljanja bolnikov).
English: Subcutaneous absorption rate was estimated to decrease with age and appeared to be fastest in the youngest patients.
Slovenian: Ocenjena hitrost absorpcije pri subkutani uporabi se s starostjo zmanjšuje in kaže, da je največja pri najmlajših bolnikih.
English: Canakinumab also reduced the risk of subsequent attacks (see Table 5).
Slovenian: Kanakinumab je zmanjšal tudi tveganje za nadaljnje napade (glejte preglednico 5).
English: Allow the area to dry.
Slovenian: Pustite, da se posuši.
English: The reconstituted solution should ideally be used immediately, but can still be used for up to 24 hours if stored in a refrigerator.
Slovenian: Rekonstituirano raztopino je najbolje porabiti takoj, vendar jo je mogoče uporabiti tudi v roku 24 ur, če je shranjena v hladilniku.
English: The absolute bioavailability of subcutaneously administered canakinumab was estimated to be 66%.
Slovenian: Absolutna biološka uporabnost subkutano vnešenega kanakinumaba je ocenjena na 66 %.
English: Reported experience with overdose is limited.
Slovenian: Podatki o izkušnjah s prevelikim odmerjanjem so omejeni.
English: Mutation in NLRP3 gene in CAPS patients
Slovenian: Mutacija gena NLRP3 pri bolnikih s CAPS
English: Results for the components of the adapted paediatric ACR which included systemic and arthritic components, were consistent with the overall ACR response results.
Slovenian: Rezultati pri posameznih postavkah prirejenih pediatričnih kriterijev ACR, ki vključujejo sistemske in sklepne komponente, so se ujemali z rezultati celotnega odziva po kriterijih ACR.
English: - It is important not to try to inject yourself until you have been trained by your healthcare professional.
Slovenian: Pomembno je, da si zdravila ne poskušate injicirati sami, dokler vas za to ni usposobil zdravstveni strokovnjak.
English: Health-related and quality of life outcomes in studies G2305 and G2301
Slovenian: Z zdravjem in kakovostjo življenja povezani izidi v študijah G2305 in G2301
English: 9/l were also observed (see section 4.4).
Slovenian: 9/l (glejte poglavje 4.4).
English: Bioavailability (AUCss) was not affected.
Slovenian: Starost ni vplivala na biološko uporabnost (AUCss) učinkovine.
English: Within each system organ class, the adverse reactions are ranked by frequency category with the most common first.
Slovenian: V okviru vsakega organskega sistema so neželeni učinki razvrščeni po kategorijah pogostnosti, pri čemer so najbolj pogosti navedeni najprej.
English: If you need to be given a live vaccine after starting treatment with Ilaris, discuss this with your doctor.
Slovenian: Če morate biti cepljeni z živim cepivom po začetku zdravljenja z zdravilom Ilaris, se o tem pogovorite s svojim zdravnikom.
English: Wash your hands with soap and water, then dry them on a clean towel.
Slovenian: Z milom in vodo si umijte roke in si jih nato obrišite s čisto brisačo.
English: Before initiation of therapy, all patients must be evaluated for both active and latent tuberculosis infection.
Slovenian: Pred začetkom zdravljenja je treba vse bolnike pregledati glede prisotnosti tako aktivne kot latentne oblike tuberkuloze.
English: Table 4 Paediatric ACR response and disease status at days 15 and 29
Slovenian: Preglednica 4 Odziv po pediatričnih kriterijih ACR in status bolezni na 15. in 29. dan
English: C-reactive protein ≤ 10 mg/l
Slovenian: C-reaktivni protein ≤ 10 mg/l
English: No
Slovenian: NE
English: The study included 243 CAPS patients (including 85 patients less than 18 years of age).
Slovenian: Študija je zajemala 243 bolnikov s CAPS (vključno s 85 bolniki, ki so bili stari manj kot 18 let).
English: Interactions between canakinumab and other medicinal products have not been investigated in formal studies.
Slovenian: Medsebojnega delovanja kanakinumaba in drugih zdravil niso raziskovali s formalnimi študijami.
English: Gouty arthritis: Ilaris is not recommended for children or adolescents under 18 years of age.
Slovenian: Urični artritis: Uporaba zdravila Ilaris ni priporočena za otroke ali mladostnike, ki so stari manj kot 18 let.
English: Do not try to administer an injection yourself if you have not been properly trained or if you are not sure how to do it.
Slovenian: Zdravila ne poskušajte injicirati sami, če se tega niste naučili ali če ne veste, kako je treba to izvesti.
English: After removing the vial from the refrigerator, check the expiry date on the vial.
Slovenian: Ko boste vzeli vialo iz hladilnika, preverite datum izteka roka uporabnosti zdravila na viali.
English: * Denotes significant p-value ≤ 0.025
Slovenian: * označuje statistično značilno vrednost p ≤0,025
English: Yes
Slovenian: DA
English: Do not inject air into the liquid.
Slovenian: Zraka ne iztiskajte v tekočino.
English: Your baby should not receive live vaccines until at least 16 weeks after you received your last dose of canakinumab before giving birth.
Slovenian: Vaš otrok ne sme prejeti živih cepiv najmanj 16 tednov po tem, ko ste prejeli zadnji odmerek kanakinumaba pred porodom.
English: Fewer patients aged 2 to < 4 years achieved complete response (57.1%) than older paediatric and adult patients.
Slovenian: Med bolniki, ki so bili stari od 2 do < 4 leta, je do popolnega odziva prišlo pri manjšem deležu bolnikov (57,1 %) kot med starejšimi pediatričnimi in odraslimi bolniki.
English: Women who are pregnant or who desire to become pregnant should therefore only be treated after a thorough benefit-risk evaluation.
Slovenian: Ženske, ki so noseče ali želijo zanositi, je zato smiselno zdraviti šele po temeljitem razmisleku o razmerju med tveganji in koristmi.
English: Treatment with canakinumab resulted in clinically relevant improvements in patients' physical function and quality of life.
Slovenian: Zdravljenje s kanakinumabom je omogočilo klinično pomembno izboljšanje telesnih funkcij in kakovosti življenja bolnikov.
English: Use immediately after first opening.
Slovenian: Zdravilo uporabite takoj po odprtju.
English: It is unknown whether the use of interleukin-1 (IL-1) inhibitors such as canakinumab increases the risk of reactivation of tuberculosis.
Slovenian: Ni znano, ali uporaba zaviralcev interlevkina-1 (zaviralcev IL-1), kot je kanakinumab, povečuje tveganje za reaktivacijo tuberkuloze.
English: Canakinumab is associated with an increased incidence of serious infections.
Slovenian: Kanakinumab je povezan s povečano pojavnostjo resnih okužb.
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Ilaris are provided with a physician information pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo pred prihodom zdravila na trg vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Ilaris, prejeli komplet podatkov za zdravnika, ki bo vseboval sledeče:
English: Always use new, unopened needles and syringes.
Slovenian: Vedno uporabite nove igle in brizge, ki še niso bile odprte.
English: Clinical experience in CAPS patients without a confirmed mutation in the NLRP3 gene is limited.
Slovenian: Kliničnih izkušenj pri bolnikih s CAPS brez potrjene mutacije gena NLRP3 je malo.
English: The study consisted of two parts with two independent primary endpoints (successful steroid taper and time to flare).
Slovenian: Študija je obsegala dve obdobji in dva neodvisna primarna cilja opazovanja (uspešno postopno zniževanje odmerkov steroidnih zdravil in čas do zagona).
English: In case of overdose, it is recommended for the patient to be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo bolnika opazovati glede morebitnih znakov in simptomov neželenih učinkov in takoj uvesti ustrezno simptomatsko zdravljenje.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ilaris in all subsets of the paediatric population in gouty arthritis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Ilaris za vse podskupine pediatrične populacije z uričnim artritisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: This means that it is injected through a short needle into the fatty tissue just under the skin.
Slovenian: To pomeni, da je zdravilo treba s kratko iglo injicirati v maščobno tkivo pod kožo.
English: A live vaccine should normally be given 3 months after your last injection of Ilaris and 3 months before the next one.
Slovenian: Živo cepivo je običajno mogoče dati 3 mesece po zadnji injekciji zdravila Ilaris in 3 mesece pred naslednjo injekcijo zdravila.
English: These symptoms could be due to a serious infection, an unusual infection (opportunistic infection) or be related to low levels of white blood cells (called leukopenia or neutropenia).
Slovenian: To so lahko simptomi resne okužbe, neobičajne (oportunistične) okužbe ali pa so povezani z znižanim številom belih krvnih celic (kar imenujemo levkopenija ali nevtropenija).
English: Periodic fever syndromes
Slovenian: Periodični vročinski sindromi
English: Ilaris is available in packs containing one vial or multipacks comprising four intermediate packs, each containing one vial.
Slovenian: Zdravilo Ilaris je na voljo v pakiranjih, ki vsebujejo po eno vialo, ali v skupnih pakiranjih, ki obsegajo štiri vmesna pakiranja, od katerih vsako vsebuje po eno vialo.
English: Wash your hands with soap and water.
Slovenian: Z milom in vodo si umijte roke.
English: Make sure all of the solution is in the bottom of the vial.
Slovenian: Preglejte, če je vsa raztopina na dnu viale.
English: Of the patients treated with 600 mg or 8 mg/kg (or even higher), 43.8% achieved complete response.
Slovenian: Med bolniki, ki so prejemali 600 mg ali 8 mg/kg (ali celo več), je do popolnega odziva prišlo pri 43,8 %.
English: This may affect your ability to drive or use tools or machines.
Slovenian: To lahko zmanjša sposobnost za vožnjo ali za uporabo naprav in upravljanje strojev.
English: The safety profile of canakinumab observed following long-term treatment in this setting was consistent with what has been observed in interventional studies in CAPS patients.
Slovenian: Varnostni profil kanakinumaba, ki so ga opažali pri dolgotrajnem zdravljenju v navedenih pogojih, se je ujemal z opažanji v intervencijskih študijah pri bolnikih s CAPS.
English: Although approximately 22% of patients receiving canakinumab required dose adjustment, only a small percentage of patients (1.2%) discontinued canakinumab due to lack of therapeutic effect.
Slovenian: Čeprav je med bolniki, ki so prejemali kanakinumab, potrebovalo prilagajanje odmerjanja približno 22 % bolnikov, je le majhen odstotek bolnikov (1,2 %) prekinil zdravljenje s kanakinumabom zaradi nezadostnega terapevtskega učinka.
English: In early clinical trials, patients and healthy volunteers received doses as high as 10 mg/kg, administered intravenously or subcutaneously, without evidence of acute toxicity.
Slovenian: V zgodnjih kliničnih preskušanjih so bolniki in zdravi prostovoljci intravensko ali subkutano prejemali odmerke do 10 mg/kg brez znakov akutne toksičnosti.
English: Never re-use syringes or needles.
Slovenian: Brizg in igel nikoli ne uporabite ponovno.
English: Tuberculosis screening
Slovenian: Presejanje za tuberkulozo
English: The study also evaluated the effect of canakinumab on the development of antibodies to standard childhood vaccines.
Slovenian: V študiji so ocenjevali tudi vpliv kanakinumaba na razvoj protiteles po cepljenju v okviru standardnega programa cepljenja v otroški dobi.
English: ALT/AST
Slovenian: Vrednosti ALT/AST
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI S ŠTEVILOM ENOT
English: Swirl the vial slowly at an angle of about 45° for approximately 1 minute and allow to stand for about 5 minutes.
Slovenian: Vialo pod kotom približno 45° približno 1 minuto počasi vrtite, nato pa jo pustite, da stoji približno 5 minut.