FrancophonIA/ELRC3.0 huggingface dataset:
English: Haemophagocytic histiocytosis/macrophage activation syndrome (MAS) has been uncommonly reported in the setting of CRS.
Slovenian: Občasno so v okviru sindroma sproščanja citokinov poročali o sindromu hemofagocitne histiocitoze/aktivacije makrofagov.
English: Efficacy results in patients ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-cell precursor ALL
Slovenian: Rezultati učinkovitosti pri bolnikih, starih ≥ 18 let, ki so imeli recidivno ali refraktarno ALL predhodniških celic B z negativnim Philadelphia kromosomom
English: Citric acid monohydrate (E330) Trehalose dihydrate Lysine hydrochloride Polysorbate 80
Slovenian: Prašek citronska kislina monohidrat (E330) trehaloza dihidrat lizinijev klorid polisorbat 80 natrijev hidroksid (za prilagoditev pH)
English: Cognitive disorder Memory impairment Dizziness
Slovenian: Psihiatrične motnje a nespečnost stanje zmedenosti dezorientiranost
English: Management of infections may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Slovenian: Obvladovanje okužb lahko zahteva začasno prekinitev ali trajno prenehanje uporabe zdravila BLINCYTO (glejte poglavje 4.2).
English: Cardiac disorders
Slovenian: Srčne bolezni tahikardija
English: Leukopenia includes leukopenia and white blood cell count decreased.
Slovenian: 4 Levkopenija obsega levkopenijo in zmanjšanje števila belih krvnih celic.
English: Grade 3 Interrupt BLINCYTO until resolved, then restart BLINCYTO at 9 mcg/day.
Slovenian: 3. stopnja Prekinite uporabo zdravila BLINCYTO, dokler učinek ne mine, nato začnite zdravilo znova uporabljati v odmerku 9 µg/dan.
English: Interrupt BLINCYTO until resolved, then restart BLINCYTO at 5 mcg/m2/day.
Slovenian: Prekinite uporabo zdravila BLINCYTO, dokler učinek ne mine, nato začnite zdravilo znova uporabljati v odmerku 5 µg/m2/dan.
English: Interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 5 mcg/m2/day.
Slovenian: Prekinite uporabo zdravila BLINCYTO, dokler učinek ni največ 1. stopnje (blag), nato začnite zdravilo znova uporabljati v odmerku 5 µg/m2/dan.
English: (%) [95% CI] CRh*, n1/n2d (%) [95% CI] Median relapse e-free survival (RFS)
Slovenian: (%) [95 % IZ] CRh*, n1/n2
English: Management of these events may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Slovenian: Obvladovanje teh dogodkov lahko zahteva začasno prekinitev ali trajno prenehanje uporabe zdravila BLINCYTO (glejte poglavje 4.2).
English: Store at 2°C - 8°C if not used immediately.
Slovenian: Če zdravilo ni uporabljeno takoj, shranjujte pri temperaturi od 2 °C - 8 °C.
English: Based on pharmacokinetic analyses, no effect of baseline liver function on blinatumomab exposure is expected and adjustment of the initial dose is not necessary (see section 5.2).
Slovenian: Na podlagi farmakokinetičnih analiz ni pričakovati, da bi izhodiščno delovanje jeter vplivalo na izpostavljenost blinatumomabu.
English: Somnolence Hypoaesthesia Cranial nerve disorder b
Slovenian: Bolezni živčevja a glavobol tremor encefalopatija afazija parestezije konvulzije kognitivna motnja okvara spomina omotica somnolenca hipestezija motnja v kranialnem živčevju b ataksija motnja govora
English: One case of fatal encephalopathy has been reported in an earlier phase II clinical single-arm study.
Slovenian: Sindrom povečane prepustnosti kapilar so opazili pri 1 bolniku v klinični študiji II.
English: c. CRi (complete remission with incomplete haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and incomplete recovery of peripheral blood counts (platelets > 100,000/microlitre or ANC > 1,000/microlitre).
Slovenian: c CRi (popolna remisija z nepopolnim hematološkim okrevanjem) je bila opredeljena kot ≤ 5 % blastov v kostnem mozgu, brez znakov bolezni in nepopolno okrevanje periferne krvne slike (trombociti > 100.000/mikroliter in absolutno število nevtrofilcev > 1.000/mikroliter).
English: a. CR was defined as M1 marrow (≤ 5% of blasts in the bone marrow), no evidence of circulating blasts or extramedullary disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre) and no relapse within 28 days.
Slovenian: a CR je bila opredeljena kot kostni mozeg M1 (≤ 5 % blastov v kostnem mozgu), brez znakov blastov v obtoku ali ekstramedularne bolezni, ter popolno okrevanje periferne krvne slike (trombociti > 100.000/mikroliter in absolutno število nevtrofilcev [ANC] > 1.000/mikroliter) ter brez relapsa v roku 28 dni.
English: Management of pancreatitis may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Slovenian: Obravnava pankreatitisa lahko zahteva začasno prekinitev ali trajno prenehanje uporabe zdravila BLINCYTO (glejte poglavje 4.2).
English: CRh* (complete remission with partial haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre).
Slovenian: b CRh* (popolna remisija z delnim hematološkim okrevanjem) je bila opredeljena kot ≤ 5 % blastov v kostnem mozgu, brez znakov bolezni in delno okrevanje periferne krvne slike (trombociti > 50.000/mikroliter in absolutno število nevtrofilcev > 500/mikroliter).
English: For patients weighing greater than or equal to 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag
Slovenian: Za bolnike s telesno maso 45 kg ali več: volumni natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, raztopine (stabilizatorja) in rekonstituiranega zdravila BLINCYTO, ki jih je treba dodati v infuzijsko vrečko
English: Overdoses resulted in adverse reactions which were consistent with the reactions observed at the recommended therapeutic dose and included fever, tremors, and headache.
Slovenian: Prevelika odmerjanja so povzročila neželene učinke, ki so se skladali z učinki, opaženimi med uporabo priporočenega terapevtskega odmerka.
English: Discontinue BLINCYTO permanently if more than one convulsion occurs.
Slovenian: Če se pojavi več kot en napad konvulzij, trajno prenehajte uporabljati zdravilo BLINCYTO.
English: Solution (stabiliser): citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
Slovenian: Raztopina (stabilizator): citronska kislina monohidrat (E330), lizinijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
English: How to store BLINCYTO
Slovenian: Shranjevanje zdravila BLINCYTO
English: Neutropenia and febrile neutropenia, including life-threatening cases, have been observed in patients receiving BLINCYTO.
Slovenian: Pri bolnikih, ki so dobivali zdravilo BLINCYTO, so opažali nevtropenijo in febrilno nevtropenijo, tudi smrtno nevarne primere.
English: BLINCYTO has been evaluated in paediatric patients with relapsed or refractory B-precursor ALL in a phase I/II dose escalation/evaluation study, in which 70 paediatric patients, aged 7 months to 17 years, were treated with the recommended dosage regimen.
Slovenian: faze, pri kateri so zdravili 70 pediatričnih bolnikov starih od 7 mesecev do 17 let po priporočeni shemi odmerjanja.
English: Prednisone 100 mg intravenously or equivalent (e.g. dexamethasone 16 mg) should be administered 1 hour prior to initiation of each cycle of BLINCYTO therapy.
Slovenian: Priporočila za premedikacijo in dodatna zdravila Eno uro pred začetkom vsakega ciklusa zdravljenja z zdravilom BLINCYTO mora bolnik dobiti 100 mg prednizona intravensko ali drugo enakovredno zdravilo (npr. 16 mg deksametazona).
English: 3 Thrombocytopenia includes platelet count decreased and thrombocytopenia.
Slovenian: Trombocitopenija obsega zmanjšanje števila trombocitov in trombocitopenijo.
English: - The solution (stabiliser) contains citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
Slovenian: - Raztopina (stabilizator) vsebuje citronsko kislino monohidrat (E330), lizinijev klorid, polisorbat 80, natrijev hidroksid in vodo za injekcije.
English: Blast free hypoplastic or aplastic bone marrow Partial remission
Slovenian: Hipoplastičen ali aplastičen kostni mozeg brez blastov
English: Neutropenia Thrombocytopenia Leukopenia
Slovenian: Rekonstituirana raztopina
English: 2.5 mL/hour
Slovenian: 2,5 ml/uro
English: For patients weighing less than 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag for 5 mcg/m2/day dose
Slovenian: Za bolnike, ki tehtajo manj kot 45 kg: volumni natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, raztopina (stabilizator) in rekonstituirano zdravilo BLINCYTO, ki jih je treba dodati infuzijski vrečki za odmerek 5 µg/m2/dan
English: • complications occurring after cancer treatment leading to increased blood levels of potassium,
Slovenian: • zapleti, ki se pojavijo po zdravljenju raka in povzročijo zvišano koncentracija kalija, sečne kisline in fosfata v krvi ter znižano koncentracijo kalcija v krvi (sindrom lize tumorja)
English: nd
Slovenian: SN
English: Yes No
Slovenian: Nihče od
English: CR was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre).
Slovenian: CR je bila opredeljena kot ≤ 5 % blastov v kostnem mozgu, brez znakov bolezni in popolno okrevanje periferne krvne slike (trombociti > 100.000/mikroliter in absolutno število nevtrofilcev > 1.000/mikroliter).
English: For patients weighing less than 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag for 15 mcg/m2/day dose
Slovenian: Za bolnike, ki tehtajo manj kot 45 kg: volumni natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, raztopine (stabilizatorja) in rekonstituiranega zdravila BLINCYTO, ki jih je treba dodati v infuzijsko vrečko za odmerek 15 µg/m2/dan
English: HR (BLINCYTO/SOC Chemo) (95% CI) p-value (2-sided)
Slovenian: Mediano celokupno preživetje, meseci Razmerje ogroženosti (zdravilo BLINCYTO/standardna kemoterapija) (95 % IZ) p-vrednost (2-stranska)
English: Tumour lysis syndrome (TLS), which may be life-threatening or fatal (grade ≥ 4) has been observed in patients receiving BLINCYTO.
Slovenian: Med uporabo zdravila BLINCYTO so opažali sindrom lize tumorja, ki je lahko smrtno nevaren ali smrten (≥ 4. stopnje).
English: Your first cycle
Slovenian: Prvi ciklus zdravljenja
English: Escalate to 28 mcg/day after 7 days if the toxicity does not recur.
Slovenian: Če se toksični učinek ne ponovi, odmerek po 7 dneh povečajte na 28 µg/dan.
English: 11 Rash includes erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular and rash pruritic.
Slovenian: Izpuščaj obsega eritem, izpuščaj, eritematozen izpuščaj, generaliziran izpuščaj, makularen izpuščaj, makulo-papulozen izpuščaj in pruritičen izpuščaj.
English: Therefore once the CSF is cleared, treatment with BLINCYTO may be initiated.
Slovenian: Zdravilo BLINCYTO se torej lahko uvede, ko je cerebrospinalna tekočina čista.
English: Powder: citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80 and sodium hydroxide.
Slovenian: Prašek: citronska kislina monohidrat (E330), trehaloza dihidrat, lizinijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
English: Relapse
Slovenian: • izpuščaj
English: BLINCYTO was also evaluated in an open-label, multicentre, single-arm phase II study of 189 patients.
Slovenian: Zdravilo BLINCYTO so ocenili tudi v odprti, multicentrični študiji II.
English: Grade 3 Interrupt BLINCYTO until no more than grade 1 (mild) and for at least 3 days, then restart BLINCYTO at 9 mcg/day.
Slovenian: 3. stopnja Prekinite uporabo zdravila BLINCYTO, dokler učinek ni največ 1. stopnje (blag), nato začnite zdravilo znova uporabljati v odmerku 9 µg/dan.
English: Toxicity
Slovenian: Toksični učinek
English: Philadelphia chromosome negative relapsed or refractory B-precursor ALL
Slovenian: Recidivna ali refraktarna ALL predhodniških celic B z negativnim Philadelphia kromosomom
English: Nausea
Slovenian: Dojenje
English: Each pack of BLINCYTO contains:
Slovenian: Eno pakiranje vsebuje:
English: Immune system disorders
Slovenian: Priprava raztopine za infundiranje
English: - if you are breast-feeding.
Slovenian: - če dojite.
English: In addition, reactivations of virus infection (e.g. Polyoma (BK)) have been observed in the phase II clinical study in adults with Philadelphia chromosome negative relapsed or refractory B-precursor ALL.
Slovenian: faze pri odraslih bolnikih z recidivno ali refraktarno ALL predhodniških celic B z negativnim Philadelphia kromosomom opazili reaktivacije virusnih okužb (npr. poliom (BK)).
English: Insomnia
Slovenian: • nespečnost
English: Ataxia
Slovenian: Odmerek
English: Citric acid monohydrate (E330) Lysine hydrochloride Polysorbate 80
Slovenian: citronska kislina monohidrat (E330) lizinijev klorid polisorbat 80 natrijev hidroksid (za prilagoditev pH) voda za injekcije
English: Leukocytosis Lymphopenia
Slovenian: Zdravilo BLINCYTO
English: Cytokine release syndrome (CRS)
Slovenian: Sindrom sproščanja citokinov
English: Lymphadenopathy Histiocytosis haematophagic
Slovenian: Bolezni krvi in limfatičnega sistema febrilna nevtropenija anemija nevtropenija trombocitopenija levkopenija levkocitoza limfopenija limfadenopatija hematofagna histiocitoza
English: n/N Rate (95% CI)
Slovenian: Delež (95 % IZ)
English: Immunisations
Slovenian: Cepljenja
English: Blast free hypoplastic or aplastic bone marrow was defined as bone marrow blasts ≤ 5%, no evidence of disease, insufficient recovery of peripheral blood counts: platelets ≤ 50,000/microlitre and/or ANC ≤ 500/microlitre.
Slovenian: brez znakov bolezni in z nezadostnim okrevanjem periferne krvne slike: trombociti ≤ 50.000/mikroliter in/ali absolutno število nevtrofilcev ≤ 500/mikroliter.
English: Sepsis Pneumonia
Slovenian: Standardna kemoterapija
English: • increase in your weight
Slovenian: • povečanje telesne mase
English: Reconstituted solution
Slovenian: Delna remisija
English: Musculoskeletal and connective tissue disorders
Slovenian: Presnovne in prehranske motnje sindrom lize tumorja
English: SOC Chemo (N=134)
Slovenian: Standardna kemoterapija (N = 134)
English: st
Slovenian: Ob
English: Preparation of the solution for infusion
Slovenian: Povezavo na navodilo za uporabo
English: Date of first authorisation: 17 July 2017
Slovenian: Datum prve odobritve: 17. julij 2017
English: I. When you have finished, release your thumb.
Slovenian: I. Ko končate, sprostite palec.
English: Q2W = every 2 weeks
Slovenian: Q2W = vsaka 2 tedna
English: Grade 3 and 4 has been observed occasionally.
Slovenian: Občasno so opazovali stopnjo 3 in 4.
English: After that, you will need to have an injection every two weeks.
Slovenian: Po tem boste injekcije prejemali vsaka dva tedna.
English: • any part appears cracked or broken.
Slovenian: • je kateri koli del videti počen ali zlomljen.
English: • Your doctor will decide how much Kyntheum you need and for how long.
Slovenian: • Zdravnik se bo odločil, koliko zdravila Kyntheum potrebujete in kako dolgo.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Slovenian: Vaš zdravnik bo redno spremljal vaše stanje, da se prepriča, ali ima vaše zdravljenje želeni učinek.
English: • if you have an infection which your doctor thinks is important (for example, active tuberculosis).
Slovenian: • če imate okužbo, za katero vaš zdravnik meni, da je pomembna (na primer aktivno tuberkulozo).
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za dojenega novorojenca/otroka ni mogoče izključiti.
English: AMAGINE-1 was conducted in 661 patients.
Slovenian: Študija AMAGINE-1 je bila opravljena pri 661 bolnikih.
English: Suicidal ideation and behaviour
Slovenian: Samomorilske misli in vedenje
English: • Do not use the syringe if:
Slovenian: • Ne uporabite brizge, če:
English: • Kyntheum is for long-term treatment.
Slovenian: • Zdravilo Kyntheum je namenjeno za dolgoročno zdravljenje.
English: Not to be sold separately.
Slovenian: Ni namenjeno izdajanju posamično.
English: Cover with plaster if needed.
Slovenian: Po potrebi ga prekrijte z obližem.
English: • if you have tuberculosis (TB), have had a positive TB test, or have been in close contact with someone with TB.
Slovenian: • če imate tuberkulozo (TB), ste bili testirani pozitivno za TB ali ste bili v stiku z nekom, ki ima
English: Only your caregiver can use:
Slovenian: Samo vaš negovalec lahko uporabi:
English: Laboratoires LEO 39 route de Chartres 28500 Vernouillet France
Slovenian: Laboratoires LEO 39 route de Chartres 28500 Vernouillet Francija
English: Quality of life/patient reported outcomes
Slovenian: Kakovost življenja/izidi po navedbah bolnikov
English: • Do not put the syringe back in the refrigerator once it has reached room temperature.
Slovenian: • Ne postavite brizge nazaj v hladilnik, ko enkrat doseže sobno temperaturo.
English: On a clean, well-lit work surface, place the:
Slovenian: Na čisto, dobro osvetljeno delovno površino položite:
English: Immediately tell your doctor or seek medical help if you get any signs of a serious infection.
Slovenian: Takoj obvestite svojega zdravnika ali poiščite zdravniško pomoč, če se vam pojavijo kakršni koli znaki resne okužbe.
English: If you stop treatment, symptoms of psoriasis may come back.
Slovenian: Če prenehate z zdravljenjem, se lahko simptomi psoriaze znova pojavijo.
English: • Do not leave the syringe in direct sunlight.
Slovenian: • Ne pustite brizge na neposredni sončni svetlobi.
English: Put the box with any unused syringes back in the refrigerator.
Slovenian: Škatlo z vsemi neuporabljenimi brizgami dajte nazaj v hladilnik.
English: Approximately 21% of patients had a history of psoriatic arthritis.
Slovenian: Približno 21 % bolnikov je imelo anamnezo psoriaznega artritisa.
English: You or your caregiver can use:
Slovenian: Vi ali vaš negovalec lahko uporabita:
English: *p-value vs. corresponding placebo, adjusted for stratification factors <0.001
Slovenian: *p-vrednost v primerjavi z ustreznim placebom, prilagojeno za faktorje stratifikacije < 0,001
English: Possible serious infections (may affect up to 1 in 100 people), the signs may include:
Slovenian: Možne resne okužbe (se lahko pojavijo pri več kot 1 od 100 ljudi), znaki lahko vključujejo:
English: Your doctor, pharmacist or nurse will tell you how often to inject the medicine.
Slovenian: Zdravnik, farmacevt ali medicinska sestra vam bodo povedali, kako pogosto injicirati zdravilo.
English: • If you want to use the same injection area each time, make sure it is not exactly the same spot that you used for a previous injection.
Slovenian: • Če želite za injiciranje vedno uporabiti isti telesni predel, se prepričajte, da ne gre za povsem isto mesto kot pri prejšnjem injiciranju.
English: • sharps disposal container (colour and appearance of container may differ depending on national requirements).
Slovenian: • zbiralnik za ostre predmete (barva in videz zbiralnika se lahko razlikujeta glede na nacionalne predpise).
English: sPGA 0 or 1 Week 12 sPGA 0 or 1 Week 52
Slovenian: sPGA 0 ali 1, 12. teden 1 sPGA 0 ali 1, 52. teden 0
English: Table 2: Overview of the main efficacy results AMAGINE-1
Slovenian: Preglednica 2: Pregled glavnih rezultatov učinkovitosti AMAGINE-1
English: Carcinogenicity studies with brodalumab have not been conducted.
Slovenian: Študij karcinogenosti z brodalumabom niso izvedli.
English: Most of these side effects are mild to moderate.
Slovenian: Večina teh neželenih učinkov je blagih do zmernih.
English: • flu (influenza)
Slovenian: • gripa (influenca),
English: The maintenance phase in AMAGINE-2 and -3 did not include placebo.
Slovenian: Faza vzdrževanja v študijah AMAGINE-2 in -3 ni vključevala placeba.
English: AMAGINE-2 and AMAGINE-3
Slovenian: AMAGINE-2 in AMAGINE-3
English: Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose.
Slovenian: Pomembno: če je po odstranitvi brizge videti, kot da je zdravilo še vedno v njej, niste prejeli celotnega odmerka.
English: Exposure-response analysis indicates that higher brodalumab concentrations are related to better PASI and sPGA response.
Slovenian: Analiza odziva na izpostavljenost je pokazala, da so višje koncentracije brodalumaba povezane z boljšim odzivom PASI in sPGA.
English: The pharmacokinetics of brodalumab was similar between Japanese and non-Japanese patients with psoriasis.
Slovenian: Druge skupine bolnikov Farmakokinetika brodalumaba je bila podobna pri japonskih in ne-japonskih bolnikih s psoriazo.
English: Component of a multipack.
Slovenian: Del skupnega pakiranja.
English: • Do not try to warm the syringe by using a heat source such as hot water or a microwave.
Slovenian: • Ne uporabljajte virov toplote za segrevanje zdravila, kot sta vroča voda ali mikrovalovna pečica.
English: • if you have recently had or you or your baby are going to have a vaccination, see "Warnings and precautions" in section "2.
Slovenian: • če ste bili pred kratkim cepljeni ali če boste vi ali vaš dojenček cepljeni, glejte »Opozorila in previdnostni ukrepi« v poglavju »2.
English: LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
Slovenian: LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Danska
English: PASI 75 Week 52 (%)
Slovenian: PASI 75, 12. teden (%) PASI 75, 52. teden (%)
English: Brodalumab clearance decreases with increasing dose and exposure increases in a greater than doseproportional manner.
Slovenian: Očistek brodalumaba se zmanjšuje s povečanjem odmerka in izpostavljenost narašča bolj kot proporcionalno glede na odmerek.
English: PSI = Psoriasis Symptom Inventory.
Slovenian: PSI = inventar simptomov psoriaze (Psoriasis Symptom Inventory).
English: Infections Kyntheum may increase the risk of infections.
Slovenian: Zdravilo Kyntheum lahko poveča tveganje za razvoj okužb.
English: Let your skin dry.
Slovenian: Počakajte, da se koža osuši.
English: C. Collect all the materials you need
Slovenian: C. Pripravite vse potrebne pripomočke.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno dokumentirati ime in številko serije prejetega zdravila.
English: Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Slovenian: Pri nekaterih bolnikih z začetnim delnim odzivom se stanje ob nadaljevanju zdravljenja preko 16 tednov lahko izboljša.
English: • if you are taking, have recently taken or might take any other medicines
Slovenian: • če uporabljate, ste pred kratkim uporabljali ali boste morda začeli uporabljati katero koli drugo zdravilo,
English: Kyntheum is not recommended for children and adolescents (below 18 years of age) because it has not been studied in this age group.
Slovenian: Zdravilo Kyntheum ni priporočljivo za otroke in mladostnike, mlajše od 18 let, ker ga pri tej starostni skupini niso preučili.
English: However, brodalumab concentrations below LLOQ (Lower Limit of Quantification) were associated with IL-17 receptor occupancy up to 81%.
Slovenian: Vendar pa so bile koncentracije brodalumaba pod LLOQ (spodnja meja kvantifikacije) povezane z zasedenostjo receptorjev IL-17 do 81 %.
English: • Keep in the original carton to protect from light or physical damage.
Slovenian: • Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo ali fizičnimi poškodbami.
English: Step 3: Injecting
Slovenian: 3. korak: Injiciranje