FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection site reactions (including injection site erythema, pain, pruritus, bruising, haemorrhage)
Slovenian: Reakcije na mestu injiciranja (vključno z eritemom, bolečino, srbenjem, modricami,
English: 1.5 ml solution in a type I glass pre-filled syringe with stainless steel 27G x ½” needle, covered with an elastomeric needle cap.
Slovenian: 1,5 ml raztopine v napolnjeni injekcijski brizgi iz stekla tipa I z iglo iz nerjavnega jekla 27G x ½” z elastomernim pokrovčkom igle.
English: Kyntheum may be stored at room temperature (up to 25°C) once, in the outer carton, for a maximum single period of 14 days.
Slovenian: Zdravilo Kyntheum lahko shranite enkrat pri sobni temperaturi (do 25 °C), v zunanji ovojnini, za najdaljše enkratno obdobje 14 dni.
English: Kyntheum pre-filled syringe can only be used once.
Slovenian: Vsako napolnjeno injekcijsko brizgo zdravila Kyntheum lahko uporabite samo enkrat.
English: None of the Grade 3 or 4 ANC decreases in the psoriasis patients were associated with a serious infection (see also section
Slovenian: Nobeno zmanjšanje števila ANC stopnje 3 ali 4 pri bolnikih s psoriazo ni bilo povezano z resnejšo okužbo (glejte tudi poglavje 4.8).
English: EU/1/16/1155/002 Multipack containing 6 (3 x 2) pre-filled syringes
Slovenian: EU/1/16/1155/002 Skupno pakiranje: 6 (3 x 2) napolnjenih injekcijskih brizg
English: The pre-filled syringe should not be used if it has been dropped on a hard surface.
Slovenian: Napolnjene injekcijske brizge ne uporabljajte, če je padla na trdo površino.
English: Kyntheum is used in adults with moderate to severe plaque psoriasis affecting large areas of the body.
Slovenian: Zdravilo Kyntheum se uporablja pri odraslih z zmerno do hudo psoriazo v plakih, ki prizadene večje telesne površine.
English: Neutropenia Grade 3 and 4 were reported in 0.4% of patients receiving Kyntheum compared to 0.2% of patients who received ustekinumab and none in patients receiving placebo.
Slovenian: O nevtropeniji 3. in 4. stopnje so poročali pri 0,4 % bolnikov, ki so prejemali zdravilo Kyntheum, v primerjavi z 0,2 % bolnikov, ki so prejemali ustekinumab, in brez primera pri bolnikih, ki so prejemali placebo.
English: Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Slovenian: Zdravilo Kyntheum je indicirano za zdravljenje zmerne do hude psoriaze v plakih pri odraslih, ki so primerni za sistemsko zdravljenje.
English: Important: Always hold the pre-filled syringe by the syringe barrel.
Slovenian: Pomembno: Napolnjeno injekcijsko brizgo vedno držite za ohišje.
English: Do not use this medicine if you notice the solution is cloudy or discoloured or contains lumps, flakes or particles.
Slovenian: Ne uporabljajte tega zdravila, če je raztopina motna ali razbarvana ali vsebuje grudice, kosmiče ali delce.
English: Do not use this medicine after the expiry date which is stated on the outer carton and label of the prefilled syringe after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki napolnjene injekcijske brizge poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Kyntheum should not be injected into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.
Slovenian: Zdravila Kyntheum se ne sme injicirati na mestih, kjer je koža občutljiva, poškodovana, pordela, trda, debela, luskasta ali prizadeta zaradi psoriaze.
English: The most commonly reported adverse reactions in all Kyntheum-treated patients were arthralgia (4.6%), headache (4.3%), fatigue (2.6%), diarrhoea (2.2%), and oropharyngeal pain (2.1%).
Slovenian: glavobol (4,3 %), utrujenost (2,6 %), diareja (2,2 %) in orofaringealna bolečina (2,1 %).
English: As a precautionary measure, it is preferable to avoid the use of Kyntheum in pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Kyntheum bolje izogibati.
English: • Do not remove the finger grips.
Slovenian: • Ne odstranite oprijemov za prste.
English: Each pre-filled syringe is for single use only.
Slovenian: Vsaka napolnjena injekcijska brizga je za enkratno uporabo.
English: Before you use a Kyntheum pre-filled syringe, read this important information: Storing your Kyntheum pre-filled syringes
Slovenian: Pred uporabo z zdravilom Kyntheum napolnjene injekcijske brizge preberite te pomembne informacije:
English: The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.
Slovenian: Priporočeni odmerek je 210 mg s subkutano injekcijo v tednih 0, 1 in 2, ki mu sledi odmerek 210 mg vsaka 2 tedna.
English: Kyntheum is a sterile solution for injection in pre-filled syringe.
Slovenian: Kyntheum je sterilna raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: The pre-filled syringe should not be warmed in any other way.
Slovenian: Napolnjene brizge ne segrevajte nikakor drugače.
English: • Do not touch this area again before injecting.
Slovenian: • Do injiciranja se ne dotaknite več tega predela.
English: For subcutaneous use
Slovenian: Za subkutano uporabo
English: Self-administration instructions
Slovenian: Navodila za samostojno uporabo
English: Based on population pharmacokinetic modelling the estimated half-life of brodalumab was 10.9 days at steady-state after every other week subcutaneous dose of 210 mg.
Slovenian: Na podlagi modeliranja populacijske farmakokinetike je bila povprečna razpolovna doba brodalumaba 10,9 dneva v stanju dinamičnega ravnovesja po subkutanem odmerjanju 210 mg vsak drugi teden.
English: Based on population pharmacokinetic modelling, the estimated mean steady-state volume of distribution of brodalumab was approximately 7.24 L.
Slovenian: Glede na modeliranje populacijske farmakokinetike je bil ocenjeni povprečni porazdelitveni volumen brodalumaba v stanju dinamičnega ravnovesja 7,24 l.
English: Medicine
Slovenian: Zdravilo
English: To avoid discomfort at the site of injection, at least 30 minutes should be allowed for the pre-filled syringe to reach room temperature before injecting.
Slovenian: Za preprečitev neprijetnega občutka na mestu injiciranja naj bo napolnjena injekcijska brizga pred injiciranjem vsaj 30 minut na sobni temperaturi.
English: At Week 12, patients originally randomised to Kyntheum were re-randomised to receive either 210 mg every 2 weeks, or 140 mg every 2 weeks, or 140 mg every 4 weeks, or 140 mg every 8 weeks during the maintenance phase.
Slovenian: Bolniki, ki so bili sprva randomizirani za uporabo zdravila Kyntheum, so bili v 12. tednu znova randomizirani za prejemanje odmerka 210 mg vsaka 2 tedna ali 140 mg vsaka 2 tedna ali 140 mg vsake 4 tedne ali 140 mg vsakih 8 tednov v času vzdrževalne faze.
English: If your doctor decides that you or a caregiver can give you injections at home, you should receive training on the right way to prepare and inject Kyntheum.
Slovenian: Če se vaš zdravnik odloči, da ste vi ali negovalec zmožni injiciranja doma, se morate vi ali vaš negovalec udeležiti usposabljanja glede pravega načina priprave in injiciranja zdravila
English: • the medicine is cloudy or discoloured or contains flakes or particles
Slovenian: • je zdravilo motno ali razbarvano ali vsebuje grudice, kosmiče ali delce,
English: Leave the syringe at room temperature for at least 30 minutes before injecting.
Slovenian: Napolnjena injekcijska brizga naj bo pred injiciranjem vsaj 30 minut na sobni temperaturi.
English: • Kyntheum is injected in your upper legs (thighs) or stomach area (abdomen) by you or a caregiver.
Slovenian: • Zdravilo Kyntheum si morate sami ali vaš negovalec injicirati v zgornji del nog (stegna) ali predel trebuha (abdomen).
English: In cynomolgus monkeys there were no effects on male and female reproductive organs and on sperm count, motility and morphology following administration of brodalumab at dose levels up to 90 mg/kg once weekly for 6 months, (AUC exposure up to 47-fold higher than in human patients receiving Kyntheum 210 mg every 2 weeks).
Slovenian: Pri opicah Cinomolgus ni bilo nobenih učinkov na moške in ženske reproduktivne organe ter na število, gibljivost in morfologijo semenčic po 6-mesečnem prejemanju brodalumaba v odmerkih do 90 mg/kg enkrat tedensko (izpostavljenost AUC do 47-krat večja kot pri bolnikih, ki so prejemali odmerek 210 mg zdravila Kyntheum vsaka 2 tedna).
English: Patients randomised to ustekinumab received 45 mg for patients ≤100 kg and 90 mg for patients >100 kg at Weeks 0, 4, and 16 followed by same dose every 12 weeks.
Slovenian: Bolniki, randomizirani za prejemanje ustekinumaba, so prejeli odmerek 45 mg pri telesni teži ≤ 100 kg in 90 mg pri telesni teži > 100 kg v tednih 0, 4 in 16, čemur je sledil enak odmerek vsakih 12 tednov.
English: Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution (140 mg/1 ml).
Slovenian: Ena napolnjena injekcijska brizga vsebuje 210 mg brodalumaba v 1,5 ml raztopine (140 mg/ml).
English: Kyntheum is used to treat a skin condition called “plaque psoriasis”, which causes inflammation and scaly plaque formation on the skin.
Slovenian: Zdravilo Kyntheum se uporablja za zdravljenje kožne bolezni, imenovane »psoriaza v plakih«, ki povzroča vnetne in luskaste spremembe na koži.
English: Although a role for interleukin (IL)-17A and IL-17RA in the regulation of CYP450 enzymes has not been reported, the effect of brodalumab on CYP3A4/3A5 activity was evaluated in a disease-drug-drug interaction study.
Slovenian: Čeprav niso poročali o vlogi interlevkinov (IL)-17A in IL-17RA pri uravnavanju encimov CYP450, je bil učinek brodalumaba na aktivnost
English: IL-17C has been shown to induce similar responses as IL-17A and IL-17F in keratinocytes.
Slovenian: Dokazali so, da IL-17C v keratocitih sproži podobne odzive kot IL-17A in IL-17F.
English: Always hold the syringe by the syringe barrel.
Slovenian: Brizgo vedno držite za ohišje.
English: Keep in the outer carton in order to protect from light.
Slovenian: Shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: It is recommended that patients be brought up-to-date with all immunisations in accordance with local immunisation guidelines prior to initiation of treatment with Kyntheum.
Slovenian: Priporočljivo je, da se bolniki pred začetkom zdravljenja z zdravilom Kyntheum seznanijo z vsemi cepljenji, skladnimi z lokalnimi smernicami za cepljenje.
English: Package leaflet: Information for the patient Kyntheum 210 mg solution for injection in pre-filled syringe brodalumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Kyntheum 210 mg raztopina za injiciranje v napolnjeni injekcijski brizgi brodalumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with anti-brodalumab antibody development.
Slovenian: Ni bilo dokazov o spremenjenem farmakokinetičnem profilu, kliničnem odzivu ali varnostnem profilu,
English: • Do not use a Kyntheum pre-filled syringe if it has been dropped on a hard surface.
Slovenian: • Ne uporabljajte z zdravilom Kyntheum napolnjene injekcijske brizge, če je padla na trdo površino, ker je morda poškodovana.
English: Throw away Kyntheum that has been stored at room temperature for longer than 14
Slovenian: Zdravilo Kyntheum zavrzite, če je bilo shranjeno pri sobni temperaturi več kot 14 dni.
English: • new syringe
Slovenian: • novo brizgo,
English: Kyntheum is a medicine that contains the active substance brodalumab.
Slovenian: Zdravilo Kyntheum vsebuje zdravilno učinkovino brodalumab.
English: Population pharmacokinetic modelling indicated that age did not have an effect on brodalumab pharmacokinetics, which was co-based on 259 (6%) patients being 65-74 years old and on 14 (0.3%)
Slovenian: Modeliranje populacijske farmakokinetike je nakazalo, da starost ni vplivala na farmakokinetiko brodalumaba, ki je bila soosnovana na 259 (6 %) bolnikih, starih med 65 in 74 leti, in na 14 (0,3 %) bolnikih, starih 75 let ali več, znotraj skupne populacije PK 4.271 bolnikov s psoriazo v plakih.
English: Tell your doctor if you think your signs and symptoms of psoriasis are not improving after using Kyntheum.
Slovenian: Če menite, da se znaki in simptomi psoriaze niso izboljšali po začetku uporabe zdravila Kyntheum, o tem obvestite svojega zdravnika.
English: Across treatment groups, the baseline Psoriasis Area Severity Index (PASI) score ranged from 9.4 to 72 (median: 17.4)
Slovenian: V zdravljenih skupinah se je izhodiščna ocena indeksa izraženosti psoriaze in velikosti prizadete površine kože (PASI - Psoriasis Area Severity Index) gibala od 9,4 do 72 (povprečno: 17,4) izhodiščna velikost prizadete površine kože (BSA) pa je bila 10-97 (povprečno: 21).
English: Patients originally randomised to placebo received Kyntheum 210 mg every 2 weeks beginning at Week 12.
Slovenian: Bolniki, ki so bili sprva randomizirani za placebo, so prejeli odmerek 210 mg zdravila Kyntheum vsaka 2 tedna z začetkom v 12. tednu.
English: • if you have a history of Crohn's disease
Slovenian: • če ste kdaj imeli Crohnovo bolezen,
English: • Put your used pre-filled syringe in a puncture resistant sharps disposal container straight after use.
Slovenian: • Napolnjeno injekcijsko brizgo takoj po uporabi zavrzite v zbiralnik za ostre predmete.
English: However, there were no proliferative changes in cynomolgus monkeys administered weekly subcutaneous doses of brodalumab at 90 mg/kg for 6 months (AUC exposure 47-fold higher than in human patients receiving Kyntheum 210 mg every 2 weeks).
Slovenian: Vendar pa ni prišlo do proliferacijskih sprememb pri opicah Cinomolgus, ki so 6 mesecev prejemale tedenski subkutani odmerek brodalumaba 90 mg/kg (47-krat višja izpostavljenost AUC kot pri bolnikih, ki so prejemali odmerek 210 mg zdravila
English: Following a single subcutaneous administration of brodalumab 210 mg in plaque psoriasis patients, the apparent clearance (CL/F) is 2.95 L/day.
Slovenian: Pri bolnikih s psoriazo v plakih, ki so prejeli en subkutani odmerek 210 mg brodalumaba, je navidezni očistek (CL/F) 2,95 l/dan.
English: If there is blood, press a cotton ball or gauze pad on your injection site.
Slovenian: Če opazite kri, na mesto injiciranja pritisnite kosem vate ali zloženec iz gaze.
English: During the 12-week placebo-controlled clinical trial period in patients with psoriasis, serious infections were observed in 0.5% of patients receiving Kyntheum (see section 4.8).
Slovenian: V 12-tedenski klinični študiji, nadzorovani s placebom, pri bolnikih s psoriazo, so resne okužbe ugotovili pri 0,5 % bolnikov, ki so prejemali zdravilo Kyntheum (glejte poglavje 4.8).
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Pogosti neželeni učinki (pojavijo se pri 1 od 10 ljudi):
English: Uncommon Candida infections (including oral, genital, and oesophageal infections)
Slovenian: Okužbe s kandido (vključno z oralnimi,
English: • Do not hold the plunger.
Slovenian: • Ne držite bata.
English: Make sure the medicine in the syringe is clear to slightly pearly and colourless to slightly yellow.
Slovenian: Prepričajte se, da je zdravilo v brizgi bistro do rahlo biserno in brezbarvno do rahlo rumenkasto.
English: The trial included a 12-week double-blind, placebocontrolled induction phase followed by a double-blind withdrawal and retreatment phase up to 52 weeks.
Slovenian: Študija je zajela 12-tedensko, dvojno slepo, s placebom nadzorovano indukcijsko fazo, ki ji je sledila dvojno slepa faza odtegnitve in nadaljevanja zdravljenja do 52 tednov.
English: After starting Kyntheum, tell your doctor, pharmacist or nurse immediately:
Slovenian: Po začetku uporabe zdravila Kyntheum se takoj posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: At Week 12, patients in the ustekinumab group continued to receive ustekinumab and then were switched to Kyntheum 210 mg every 2 weeks at Week 52.
Slovenian: 12. teden so bolniki, ki so bili v skupini ustekinumaba, še naprej prejemali ustekinumab, nato pa 52. teden začeli prejemati odmerek 210 mg zdravila Kyntheum vsaka 2 tedna.
English: Elevated levels of expression of IL-12B and IL-23A, the genes for the two subunits of IL-23, an upstream activator of IL-17A and IL-17F expression, are also found in psoriatic plaques.
Slovenian: V psoriaznih plakih najdemo tudi povišane ravni ekspresije IL-12B in IL-23A, genov dveh podenot IL-23, aktivatorja ekspresije IL-17A in IL-17F.
English: Kyntheum can be kept at room temperature up to 25°C in the outer carton for 14 days.
Slovenian: Zdravilo Kyntheum lahko shranjujete pri sobni temperaturi do 25 °C v zunanji ovojnini največ 14 dni.
English: Kyntheum is given as an injection under the skin (known as a subcutaneous injection).
Slovenian: Zdravilo Kyntheum dajemo s podkožno injekcijo (imenovano subkutana injekcija).
English: It is therefore preferable to avoid the use of Kyntheum during pregnancy.
Slovenian: Med nosečnostjo se torej uporaba zdravila Kyntheum ne priporoča.
English: If a patient suffers from new or worsening symptoms of depression and/or suicidal ideation or behaviour is identified, it is recommended to discontinue treatment with Kyntheum.
Slovenian: Če se pri bolniku pojavijo simptomi depresije oziroma se ti poslabšajo in/ali če se pri njih prepozna pojav samomorilskih misli ali vedenja,
English: You may be treated with another medicine for TB before you begin treatment with Kyntheum
Slovenian: Pred začetkom zdravljenja z zdravilom Kyntheum boste morda zdravljeni z drugim zdravilom za TB,
English: The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g. IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation.
Slovenian: Zvišana koncentracija nekaterih citokinov (npr. IL-1, IL-6, IL-10, TNFα, IFN) pri kroničnem vnetju lahko vpliva na tvorbo encimov CYP450.
English: Water for injections
Slovenian: raztopina za injiciranje
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Okužbe
English: • Do not inject into areas where the skin is tender, bruised red, or hard.
Slovenian: • Ne injicirajte zdravila na mestih, kjer je koža občutljiva, poškodovana, pordela ali trda.
English: Kyntheum 210 mg injection brodalumab
Slovenian: Kyntheum 210 mg injekcija brodalumab s.c.
English: Renal elimination of intact brodalumab, an IgG monoclonal antibody, is expected to be low and of minor consequence.
Slovenian: Pričakovano je, da je izločanje nespremenjenega brodalumaba, humanega monoklonskega protitelesa IgG, skozi ledvice majhno in brez večjega pomena.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Kyntheum Vsebina pakiranja in dodatne informacije
English: Kyntheum is available as a single-use pre-filled syringe.
Slovenian: Zdravilo Kyntheum je na voljo kot napolnjena injekcijska brizga za enkratno uporabo.
English: Oropharyngeal pain
Slovenian: Ohišje brizge
English: Label and expiration date
Slovenian: Nalepka in rok uporabnosti
English: Kyntheum is administered by subcutaneous injection.
Slovenian: Zdravilo Kyntheum je namenjeno za subkutano injiciranje.
English: Important: Always keep the sharps disposal container out of the sight and the reach of children.
Slovenian: Pomembno: zbiralnik za ostre predmete vedno shranjujte nedosegljiv otrokom.
English: Both trials included a 12-week double-blind, placebo- and ustekinumab-controlled induction phase followed by a double-blind maintenance phase up to 52 weeks.
Slovenian: Obe študiji sta vključevali 12-tedensko dvojno slepo, s placebom in ustekinumabom nadzorovano indukcijsko fazo, ki ji je sledila dvojno slepa vzdrževalna faza do 52 tednov.
English: • Do not inject into an area of the skin that is tender, bruised, red, hard or in an area of skin that is affected by psoriasis.
Slovenian: • Zdravila ne injicirajte na mestu, kjer je koža občutljiva, poškodovana, pordela ali trda, ali na mestu, ki je prizadeto zaradi psoriaze.
English: Patients originally randomised to placebo and those who did not meet the criteria for re-randomisation received Kyntheum 210 mg every two weeks beginning at Week 12.
Slovenian: Bolniki, ki so bili sprva randomizirani za uporabo placeba in ki niso izpolnili kriterijev za vnovično randomizacijo, so prejemali odmerek 210 mg zdravila Kyntheum vsaka dva tedna; prvi odmerek so prejeli 12. teden.
English: • your outer area of upper arm.
Slovenian: • zunanji del nadlakti.
English: Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 210 mg brodalumaba v 1,5 ml raztopine.
English: Live vaccines should not be given concurrently with Kyntheum (see section 4.4).
Slovenian: Zdravilo Kyntheum se ne sme uporabljati skupaj z živimi cepivi (glejte poglavje 4.4).
English: Live vaccines should not be given concurrently with Kyntheum (see section 4.5).
Slovenian: Zdravilo Kyntheum se ne sme uporabljati skupaj z živimi cepivi (glejte poglavje 4.5).
English: How much Kyntheum is given
Slovenian: Koliko zdravila Kyntheum je treba uporabiti
English: pharmacist or nurse if you or your caregiver have any questions about the right way to inject Kyntheum.
Slovenian: Če imate vi ali vaš negovalec kakršna koli vprašanja o pravilnem načinu injiciranja zdravila
English: Throw the needle cap into the sharps disposal container provided.
Slovenian: Pokrovček igle zavrzite v zbiralnik za ostre predmete.
English: The observed pharmacokinetic parameters during steady-state (weeks 10-12) were: mean steady-state area under the concentration time curve over the dosing interval (AUCtau) was 227.4 mcg*day/ml (SD = 191.7 mcg*day/ml) corresponding to average concentration (Cav,ss) of 16.2 mcg/ml, mean Cmax was 20.9 mcg/ml (SD = 17.0 mcg/ml) and Week 12 mean minimum serum concentration (Ctrough) was 9.8 mcg/ml (SD = 11.2 mcg/ml).
Slovenian: (Cav,ss) 16,2 mcg/ml, povprečni Cmaks je bil 20,9 mcg/ml (SD = 17,0 mcg/ml) in povprečna minimalna serumska koncentracija v 12. tednu (Cnajnižje) je bila 9,8 mcg/ml (SD = 11,2 mcg/ml).
English: During the 12-week placebo-controlled period of clinical trials, neutropenia was reported in 0.8% of patients treated with Kyntheum compared with 0.5% of patients treated with placebo.
Slovenian: V 12-tedenski klinični študiji, nadzorovani s placebom, so ugotovili nevtropenijo pri 0,8 % bolnikih, ki so prejemali zdravilo Kyntheum, v primerjavi z 0,5 % bolnikov, ki so prejemali placebo.
English: In a local tolerance test in rabbits, moderate to severe edema was observed after subcutaneous injection of a formulation containing brodalumab at the clinical concentration of 140 mg/ml.
Slovenian: Ni bilo nobenih učinkov na imunofenotipizacijo periferne krvi in preskus odziva protiteles, odvisnih od limfocitov T. Pri lokalnem testu tolerance pri kuncih so opazili zmerne do hude edeme po subkutani injekciji formulacije, ki je vsebovala klinično koncentracijo 140 mg/ml brodalumaba.
English: Exercise caution when prescribing Kyntheum to patients with a history of Crohn's disease.
Slovenian: Pri predpisovanju zdravila Kyntheum bolnikom s Crohnovo boleznijo v anamnezi je potrebna previdnost.
English: Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Slovenian: Pri uporabi tega zdravila vedno natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
English: Headache
Slovenian: Glavobol
English: Solution for injection 2 pre-filled syringes.
Slovenian: 2 napolnjeni injekcijski brizgi.
English: • candida (fungal) infection in the mouth, throat or genitals • discharge from the eye with itching, redness and swelling (conjunctivitis).
Slovenian: • izloček iz očesa, ki ga spremlja srbenje, pordelost in otekanje (konjunktivitis).
English: Patients randomised to Kyntheum in the induction phase received 210 mg or 140 mg at Week 0 (day 1), Week 1, and Week 2 followed by same dose every 2 weeks.
Slovenian: Bolniki, ki so bili randomizirani za uporabo zdravila Kyntheum v indukcijski fazi, so prejeli odmerke 210 mg ali 140 mg v tednu 0 (dan 1), tednu 1 in tednu 2, čemur je sledil enak odmerek vsaka 2 tedna.