natgillin/translations-raw huggingface dataset:
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%).
glavobol (4,3 %), utrujenost (2,6 %), diareja (2,2 %) in orofaringealna bolečina (2,1 %).
As a precautionary measure, it is preferable to avoid the use of Kyntheum in pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Kyntheum bolje izogibati.
• Do not remove the finger grips.
• Ne odstranite oprijemov za prste.
Each pre-filled syringe is for single use only.
Vsaka napolnjena injekcijska brizga je za enkratno uporabo.
Before you use a Kyntheum pre-filled syringe, read this important information: Storing your Kyntheum pre-filled syringes
Pred uporabo z zdravilom Kyntheum napolnjene injekcijske brizge preberite te pomembne informacije:
The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.
Priporočeni odmerek je 210 mg s subkutano injekcijo v tednih 0, 1 in 2, ki mu sledi odmerek 210 mg vsaka 2 tedna.
Kyntheum is a sterile solution for injection in pre-filled syringe.
Kyntheum je sterilna raztopina za injiciranje v napolnjeni injekcijski brizgi.
The pre-filled syringe should not be warmed in any other way.
Napolnjene brizge ne segrevajte nikakor drugače.
• Do not touch this area again before injecting.
• Do injiciranja se ne dotaknite več tega predela.
For subcutaneous use
Za subkutano uporabo
Self-administration instructions
Navodila za samostojno uporabo
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.
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.
Based on population pharmacokinetic modelling, the estimated mean steady-state volume of distribution of brodalumab was approximately 7.24 L.
Glede na modeliranje populacijske farmakokinetike je bil ocenjeni povprečni porazdelitveni volumen brodalumaba v stanju dinamičnega ravnovesja 7,24 l.
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.
Za preprečitev neprijetnega občutka na mestu injiciranja naj bo napolnjena injekcijska brizga pred injiciranjem vsaj 30 minut na sobni temperaturi.
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.
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.
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.
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
• the medicine is cloudy or discoloured or contains flakes or particles
• je zdravilo motno ali razbarvano ali vsebuje grudice, kosmiče ali delce,
Leave the syringe at room temperature for at least 30 minutes before injecting.
Napolnjena injekcijska brizga naj bo pred injiciranjem vsaj 30 minut na sobni temperaturi.
• Kyntheum is injected in your upper legs (thighs) or stomach area (abdomen) by you or a caregiver.
• Zdravilo Kyntheum si morate sami ali vaš negovalec injicirati v zgornji del nog (stegna) ali predel trebuha (abdomen).
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).
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).
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.
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.
Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution (140 mg/1 ml).
Ena napolnjena injekcijska brizga vsebuje 210 mg brodalumaba v 1,5 ml raztopine (140 mg/ml).
Kyntheum is used to treat a skin condition called “plaque psoriasis”, which causes inflammation and scaly plaque formation on the skin.
Zdravilo Kyntheum se uporablja za zdravljenje kožne bolezni, imenovane »psoriaza v plakih«, ki povzroča vnetne in luskaste spremembe na koži.
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.
Čeprav niso poročali o vlogi interlevkinov (IL)-17A in IL-17RA pri uravnavanju encimov CYP450, je bil učinek brodalumaba na aktivnost
IL-17C has been shown to induce similar responses as IL-17A and IL-17F in keratinocytes.
Dokazali so, da IL-17C v keratocitih sproži podobne odzive kot IL-17A in IL-17F.
Always hold the syringe by the syringe barrel.
Brizgo vedno držite za ohišje.
Keep in the outer carton in order to protect from light.
Shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
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.
Priporočljivo je, da se bolniki pred začetkom zdravljenja z zdravilom Kyntheum seznanijo z vsemi cepljenji, skladnimi z lokalnimi smernicami za cepljenje.
Package leaflet: Information for the patient Kyntheum 210 mg solution for injection in pre-filled syringe brodalumab This medicine is subject to additional monitoring.
Navodilo za uporabo Kyntheum 210 mg raztopina za injiciranje v napolnjeni injekcijski brizgi brodalumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with anti-brodalumab antibody development.
Ni bilo dokazov o spremenjenem farmakokinetičnem profilu, kliničnem odzivu ali varnostnem profilu,
• Do not use a Kyntheum pre-filled syringe if it has been dropped on a hard surface.
• Ne uporabljajte z zdravilom Kyntheum napolnjene injekcijske brizge, če je padla na trdo površino, ker je morda poškodovana.
Throw away Kyntheum that has been stored at room temperature for longer than 14
Zdravilo Kyntheum zavrzite, če je bilo shranjeno pri sobni temperaturi več kot 14 dni.
• new syringe
• novo brizgo,
Kyntheum is a medicine that contains the active substance brodalumab.
Zdravilo Kyntheum vsebuje zdravilno učinkovino brodalumab.
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%)
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.
Tell your doctor if you think your signs and symptoms of psoriasis are not improving after using Kyntheum.
Če menite, da se znaki in simptomi psoriaze niso izboljšali po začetku uporabe zdravila Kyntheum, o tem obvestite svojega zdravnika.
Across treatment groups, the baseline Psoriasis Area Severity Index (PASI) score ranged from 9.4 to 72 (median: 17.4)
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).
Patients originally randomised to placebo received Kyntheum 210 mg every 2 weeks beginning at Week 12.
Bolniki, ki so bili sprva randomizirani za placebo, so prejeli odmerek 210 mg zdravila Kyntheum vsaka 2 tedna z začetkom v 12. tednu.
• if you have a history of Crohn's disease
• če ste kdaj imeli Crohnovo bolezen,
• Put your used pre-filled syringe in a puncture resistant sharps disposal container straight after use.
• Napolnjeno injekcijsko brizgo takoj po uporabi zavrzite v zbiralnik za ostre predmete.
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).
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
Following a single subcutaneous administration of brodalumab 210 mg in plaque psoriasis patients, the apparent clearance (CL/F) is 2.95 L/day.
Pri bolnikih s psoriazo v plakih, ki so prejeli en subkutani odmerek 210 mg brodalumaba, je navidezni očistek (CL/F) 2,95 l/dan.
If there is blood, press a cotton ball or gauze pad on your injection site.
Če opazite kri, na mesto injiciranja pritisnite kosem vate ali zloženec iz gaze.
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).
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).
Uncommon side effects (may affect up to 1 in 100 people)
Pogosti neželeni učinki (pojavijo se pri 1 od 10 ljudi):
Uncommon Candida infections (including oral, genital, and oesophageal infections)
Okužbe s kandido (vključno z oralnimi,
• Do not hold the plunger.
• Ne držite bata.
Make sure the medicine in the syringe is clear to slightly pearly and colourless to slightly yellow.
Prepričajte se, da je zdravilo v brizgi bistro do rahlo biserno in brezbarvno do rahlo rumenkasto.
The trial included a 12-week double-blind, placebocontrolled induction phase followed by a double-blind withdrawal and retreatment phase up to 52 weeks.
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.
After starting Kyntheum, tell your doctor, pharmacist or nurse immediately:
Po začetku uporabe zdravila Kyntheum se takoj posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
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.
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.
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.
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.
Kyntheum can be kept at room temperature up to 25°C in the outer carton for 14 days.
Zdravilo Kyntheum lahko shranjujete pri sobni temperaturi do 25 °C v zunanji ovojnini največ 14 dni.
Kyntheum is given as an injection under the skin (known as a subcutaneous injection).
Zdravilo Kyntheum dajemo s podkožno injekcijo (imenovano subkutana injekcija).
It is therefore preferable to avoid the use of Kyntheum during pregnancy.
Med nosečnostjo se torej uporaba zdravila Kyntheum ne priporoča.
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.
Če se pri bolniku pojavijo simptomi depresije oziroma se ti poslabšajo in/ali če se pri njih prepozna pojav samomorilskih misli ali vedenja,
You may be treated with another medicine for TB before you begin treatment with Kyntheum
Pred začetkom zdravljenja z zdravilom Kyntheum boste morda zdravljeni z drugim zdravilom za TB,
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.
Zvišana koncentracija nekaterih citokinov (npr. IL-1, IL-6, IL-10, TNFα, IFN) pri kroničnem vnetju lahko vpliva na tvorbo encimov CYP450.
Water for injections
raztopina za injiciranje
Description of selected adverse reactions
Opis izbranih neželenih učinkov Okužbe
• Do not inject into areas where the skin is tender, bruised red, or hard.
• Ne injicirajte zdravila na mestih, kjer je koža občutljiva, poškodovana, pordela ali trda.
Renal elimination of intact brodalumab, an IgG monoclonal antibody, is expected to be low and of minor consequence.
Pričakovano je, da je izločanje nespremenjenega brodalumaba, humanega monoklonskega protitelesa IgG, skozi ledvice majhno in brez večjega pomena.
Contents of the pack and other information
Shranjevanje zdravila Kyntheum Vsebina pakiranja in dodatne informacije
Kyntheum is available as a single-use pre-filled syringe.
Zdravilo Kyntheum je na voljo kot napolnjena injekcijska brizga za enkratno uporabo.
Oropharyngeal pain
Ohišje brizge
Label and expiration date
Nalepka in rok uporabnosti
Kyntheum is administered by subcutaneous injection.
Zdravilo Kyntheum je namenjeno za subkutano injiciranje.
Important: Always keep the sharps disposal container out of the sight and the reach of children.
Pomembno: zbiralnik za ostre predmete vedno shranjujte nedosegljiv otrokom.
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.
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.
• 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.
• Zdravila ne injicirajte na mestu, kjer je koža občutljiva, poškodovana, pordela ali trda, ali na mestu, ki je prizadeto zaradi psoriaze.
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.
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.
• your outer area of upper arm.
• zunanji del nadlakti.
Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
Ena napolnjena injekcijska brizga vsebuje 210 mg brodalumaba v 1,5 ml raztopine.
Live vaccines should not be given concurrently with Kyntheum (see section 4.4).
Zdravilo Kyntheum se ne sme uporabljati skupaj z živimi cepivi (glejte poglavje 4.4).
Live vaccines should not be given concurrently with Kyntheum (see section 4.5).
Zdravilo Kyntheum se ne sme uporabljati skupaj z živimi cepivi (glejte poglavje 4.5).
How much Kyntheum is given
Koliko zdravila Kyntheum je treba uporabiti
pharmacist or nurse if you or your caregiver have any questions about the right way to inject Kyntheum.
Če imate vi ali vaš negovalec kakršna koli vprašanja o pravilnem načinu injiciranja zdravila
Throw the needle cap into the sharps disposal container provided.
Pokrovček igle zavrzite v zbiralnik za ostre predmete.
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).
(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).
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.
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.
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.
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.
Exercise caution when prescribing Kyntheum to patients with a history of Crohn's disease.
Pri predpisovanju zdravila Kyntheum bolnikom s Crohnovo boleznijo v anamnezi je potrebna previdnost.
Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Pri uporabi tega zdravila vedno natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
Headache
Glavobol
Solution for injection 2 pre-filled syringes.
2 napolnjeni injekcijski brizgi.
• candida (fungal) infection in the mouth, throat or genitals • discharge from the eye with itching, redness and swelling (conjunctivitis).
• izloček iz očesa, ki ga spremlja srbenje, pordelost in otekanje (konjunktivitis).
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.
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.
Kyntheum 210 mg solution for injection in pre-filled syringe
Kyntheum 210 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Finger grips
Oprijem za prste
Elderly (aged 65 years and over) No dose adjustment is recommended in elderly patients (see section 5.2).
Prilagajanje odmerkov za starejše bolnike ni potrebno (glejte poglavje 5.2).
The ‘Instructions for Use' should be consulted for detailed instructions on administration of Kyntheum.
Podrobna navodila za uporabo zdravila Kyntheum najdete v priloženem »Navodilu za uporabo«.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ PODATKOV V t.i. MODREM OKENCU)
Patients randomised to Kyntheum received 210 mg or 140 mg at Week 0 (day 1), Week 1, and Week 2 followed by same dose every 2 weeks.
Bolniki, ki so bili randomizirani za uporabo zdravila Kyntheum, 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.
You should not be given certain types of vaccines (called ‘live vaccines') while being treated with Kyntheum
»živa cepiva«) ne smete prejemati med zdravljenjem z zdravilom Kyntheum,
Other populations
DRUGI PODATKI
• warm, red and painful skin, or a painful skin rash with blisters.
• občutek utrujenosti ali oteženega dihanja, kašelj, ki ne mine, • toplo, rdečo in bolečo kožo ali boleč kožni izpuščaj z mehurčki.
Solution for injection (injection) The solution is clear to slightly opalescent, colourless to slightly yellow and free from particles.
raztopina za injiciranje (injekcija) Raztopina je bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta in brez delcev.
Solution for injection 2 pre-filled syringes
raztopina za injiciranje 2 napolnjeni injekcijski brizgi
During the 12-week placebo-controlled trial period in plaque psoriasis, infections were reported in 25.4% of patients treated with Kyntheum compared with 23.4% of patients treated with placebo.
V 12-tedenski klinični študiji, nadzorovani s placebom, pri bolnikih s psoriazo v plakih, so o okužbah poročali pri 25,4 % bolnikov, zdravljenih z zdravilom Kyntheum, v primerjavi s 23,4 % bolnikov,
• Do not grasp the grey needle cap.
• Ne zgrabite sivega pokrovčka igle.
During the 12-week placebo-controlled clinical trial period in patients with psoriasis, a decrease in absolute neutrophil count (ANC) was observed in 5.6% of patients receiving Kyntheum, which was generally transient and reversible.
V 12-tedenski klinični študiji, nadzorovani s placebom, pri bolnikih s psoriazo, so opazili zmanjšanje absolutnega števila nevtrofilcev (ANC - absolute neutrophil count) pri 5,6 % bolnikih, ki so prejemali
The pre-filled syringe must not be shaken.
Napolnjene injekcijske brizge ne smete stresati.
• Avoid injecting into areas with scars or stretch marks.
• Ne injicirajte na predelih z brazgotinami ali strijami.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INLCUDING BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA SKUPNO PAKIRANJE (S PODATKI V t.i. MODREM OKENCU)
B.
TB.
Kyntheum 210 mg solution for injection in pre-filled syringe brodalumab
Kyntheum 210 mg raztopina za injiciranje v napolnjeni injekcijski brizgi brodalumab
How is Kyntheum given
Kako se daje zdravilo Kyntheum
In cynomolgus monkeys, no effects on embryo-foetal or postnatal (up to 6 months of age) development were observed when brodalumab was dosed subcutaneously throughout pregnancy at exposure levels up to 27-fold higher than those achieved in human patients receiving Kyntheum 210 mg every 2 weeks based on the area under the concentration curve (AUC).
(do 6 mesecev starosti) pri subkutanem odmerjanju brodalumaba med brejostjo pri do 27-krat višjih stopnjah izpostavljenosti kot pri bolnikih, ki so prejemali odmerek 210 mg zdravila Kyntheum vsaka 2 tedna na podlagi površine pod krivuljo koncentracije (AUC).
• Do not twist or bend the grey needle cap. • Do not put the grey needle cap back onto the syringe.
• Ne obračajte ali ukrivljajte sivega pokrovčka igle.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Kyntheum therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Kyntheum, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
PSIBaseline score (mean±SD) PSIresponder Week 12 (%)
PSIbolniki z odzivom, 12. teden
• Avoid injecting directly into raised, thick, red or scaly skin patches or lesions.
• Ne injicirajte neposredno na dvignjena, debela, pordela ali luskasta mesta na koži ali lezije.
• Do not shake the syringe.
• Ne stresajte brizge.
Elevated levels of IL-17A, IL-17C and IL-17F gene expression are found in psoriatic plaques.
V psoriaznih plakih najdemo povišane ravni ekspresije genov citokinov IL-17A, IL-17C in IL-17F.
Suicidal ideation and behaviour, including completed suicide, have been reported in patients treated with Kyntheum.
Pri bolnikih, ki so bili zdravljeni z zdravilom Kyntheum, so poročali o samomorilskih mislih in vedenju, vključno z izvedenim samomorom.