FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and should use adequate contraception while using Kyntheum and for at least 12 weeks after the last dose of Kyntheum.
Slovenian: Če ste ženska v rodni dobi, morate poskrbeti za preprečevanje zanositve z uporabo ustrezne kontracepcije v času, ko uporabljate zdravilo Kyntheum, in še najmanj 12 tednov po zadnjem odmerku zdravila Kyntheum.
English: D. Prepare and clean the area where you will inject
Slovenian: D. Pripravite in očistite mesto injiciranja.
English: Kyntheum should be prescribed to you by a doctor with experience in diagnosing and treating psoriasis.
Slovenian: Zdravilo Kyntheum vam mora predpisati zdravnik z izkušnjami pri diagnosticiranju in zdravljenju psoriaze.
English: The median time to maximum concentration (Tmax) was 3.0 days (range: 2.0 to 4.0 days) and the mean area under the concentration time curve to the last measurable concentration (AUClast) was 111 mcg*day/ml (SD = 64.4 mcg*day/ml).
Slovenian: Mediani čas do najvišje koncentracije (Tmaks) je bil 3,0 dneva (razpon: od 2,0 do 4,0 dneva) in povprečna površina pod krivuljo časovnega poteka koncentracije do zadnje merljive koncentracije (AUCzadnje) je bila 111 mcg*dan/ml (SD = 64,4 mcg*dan/ml).
English: Non-responder imputation is used to impute missing data.
Slovenian: Za opredelitev manjkajočih podatkov se uporablja imputacija manjkajočih podatkov za bolnike, ki se niso odzvali.
English: Call your doctor, pharmacist or nurse immediately.
Slovenian: Takoj pokličite zdravnika, farmacevta ali medicinsko sestro.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment.
Slovenian: Pri bolnikih, ki se po 12 do 16 tednih niso odzvali na zdravljenje, je treba razmisliti o prekinitvi zdravljenja.
English: Kyntheum has no influence on your ability to drive and use machines.
Slovenian: Zdravilo Kyntheum nima vpliva na vašo sposobnost vožnje in upravljanja strojev.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Step 1: Preparing A. Remove the Kyntheum pre-filled syringe from the box
Slovenian: 1. korak: Priprava A. Z zdravilom Kyntheum napolnjeno injekcijsko brizgo vzemite iz škatle.
English: AMAGINE-2 and AMAGINE-3 were also active comparator (ustekinumab)-controlled.
Slovenian: AMAGINE-2 in AMAGINE-3 sta bili tudi nadzorovani z aktivno primerjavo z ustekinumabom.
English: Then, gently remove the syringe from your skin
Slovenian: Nato nežno odstranite brizgo iz kože.
English: Along with primary efficacy endpoints, clinically important improvements were observed in Psoriasis Scalp Severity Index (PSSI) at Week 12 (AMAGINE-1) and in Nail Psoriasis Severity Index (NAPSI) at Week 12 and 52 (AMAGINE-1,-2, and -3).
Slovenian: Poleg primarne učinkovitosti opazovanega dogodka so klinično pomembno izboljšanje opazili pri indeksu jakosti psoriaze lasišča (PSSI - Psoriasis Scalp Severity Index) v 12. tednu (AMAGINE-1) in indeksu jakosti psoriaze nohtov (NAPSI - Nail Psoriasis Severity Index) v 12. in 52. tednu (AMAGINE-1,-2 in-3).
English: K. Check the injection site
Slovenian: K. Preglejte mesto injiciranja.
English: Together you will consider the benefit of breast-feeding to the baby and the benefit of Kyntheum to you.
Slovenian: Z zdravnikom bosta razmislila o koristih dojenja za dojenčka in koristih zdravila Kyntheum za vas.
English: Most adverse reactions of Kyntheum-associated neutropenia observed were mild, transient and reversible.
Slovenian: Večina neželenih učinkov nevtropenije, povezanih z zdravilom Kyntheum, je bila blaga, prehodna in reverzibilna.
English: • if you have been told by your doctor that you have developed Crohn's disease
Slovenian: • če vam je zdravnik povedal, da ste zboleli za Crohnovo boleznijo,
English: • Do not shake the pre-filled syringe before use.
Slovenian: • Ne stresajte napolnjene injekcijske brizge pred uporabo.
English: IL-17A, IL-17F and IL-17A/F heterodimer have pleiotropic activities including the induction of proinflammatory mediators such as IL-6, GROα, and G-CSF from epithelial cells, endothelial cells and fibroblasts that promote tissue inflammation.
Slovenian: IL-17F in IL-17A/F heterodimer imajo pleiotropične aktivnosti, vključno z indukcijo provnetnih mediatorjev, kot so IL-6, GROα in G-CSF iz epitelijskih celic, endotelijskih celic in fibroblastov, ki spodbujajo vnetje tkiva.
English: The percentage of patients that at Week 12 achieved a DLQI (Dermatology Life Quality Index) score of 0 or 1 was 56%, 61%, 59% in the Kyntheum 210 mg group and 5%, 5%, 7% in the placebo group in AMAGINE-1, -2 and -3, respectively (adjusted p-value <0.001) and 44% in the ustekinumab groups (AMAGINE-2 and -3).
Slovenian: Odstotek bolnikov, ki so v 12. tednu dosegli oceno dermatološkega indeksa kakovosti življenja (Dermatology Life Quality Index - DLQI) 0 ali 1 je bil 56 %, 61 %, 59 % v skupini, ki je prejemala zdravilo Kyntheum v odmerku 210 mg in 5 %, 5 %, 7 % v skupini, ki je prejemala placebo v posamezni študiji AMAGINE-1, -2 in -3 (prilagojena p-vrednost< 0,001) in 44 % v skupini, ki je prejemala ustekinumab (AMAGINE -2 in -3).
English: Treatment with Kyntheum in psoriasis patients has been shown to decrease levels of IL-17A and markers of cell proliferation and epidermal thickness in lesional skin biopsies to non-lesional skin biopsy levels up to 12 weeks post-treatment.
Slovenian: Zdravljenje z zdravilom Kyntheum pri bolnikih s psoriazo je povzročilo znižanje ravni IL-17A in označevalcev celične proliferacije ter debeline epidermija pri biopsijah kože z lezijami na ravni biopsije kože brez lezij do 12 tednov po zdravljenju.
English: As the metabolism of brodalumab is unknown in infants, benefit risk for exposure of the infant to live vaccines following third trimester exposure to Kyntheum should be discussed with a physician.
Slovenian: Ker presnova brodalumaba pri dojenčkih ni znana, se je treba o koristih in tveganjih izpostavljenosti dojenčka živim cepivom, ki sledi izpostavljenosti zdravilu Kyntheum v tretjem trimesečju, posvetovati z zdravnikom.
English: • Clean the area where you plan to inject with an alcohol wipe.
Slovenian: • Mesto injiciranja očistite z alkoholnim zložencem.
English: Brodalumab is a monoclonal antibody, a specialised type of protein that recognises and attaches to certain proteins in the body.
Slovenian: Monoklonska protitelesa so posebna vrsta beljakovin, ki prepoznajo in se specifično vežejo na določene beljakovine v telesu.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity (including safety pharmacology endpoints and assessment of fertility-related endpoints), and toxicity to reproduction and development.
Slovenian: 5.3 Predklinični podatki o varnosti Neklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih se odmerkih (vključno z varnostnimi farmakološkimi opazovanimi dogodki in oceno opazovanih dogodkov, povezanih s plodnostjo) in študij reproduktivne toksičnosti ter toksičnosti za razvoj ne kažejo posebnega tveganja za človeka.
English: • if you are allergic to brodalumab or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na brodalumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6), • če imate aktivno Crohnovo bolezen,
English: Each syringe contains one 210 mg dose of Kyntheum.
Slovenian: Vsaka brizga vsebuje en odmerek 210 mg zdravila Kyntheum.
English: Figure 1: PASI 100 during induction and maintenance phase for Kyntheum and ustekinumab (AMAGINE-2 and AMAGINE-3, pooled)
Slovenian: Slika 1: PASI 100 med fazo indukcije in fazo vzdrževanja za zdravilo Kyntheum in ustekinumab (AMAGINE-2 in AMAGINE-3, skupno)
English: • if you have an infection now or often get infections
Slovenian: • če ravno prebolevate okužbo ali imate pogoste okužbe,
English: However, Kyntheum should not be given to patients with active tuberculosis.
Slovenian: Vendar bolniki z aktivno tuberkulozo ne smejo prejemati zdravila Kyntheum.
English: For a 3-fold increase in SC brodalumab dose from 70 to 210 mg, the steady-state serum brodalumab Cmax and AUC0-t increased approximately 18- and 25-fold, respectively.
Slovenian: Pri 3-kratnem povečanju odmerka s.c. brodalumaba s 70 na 210 mg se je dinamično ravnovesje serumskih vrednosti brodalumaba Cmaks in AUC0-t povečalo za približno 18-krat oziroma 25-krat.
English: - The other ingredients are proline, glutamate, polysorbate 20 and water for injections.
Slovenian: - Druge sestavine so prolin, glutamat, polisorbat 20 in voda za injekcije.
English: One serious case of cryptococcal meningitis and one serious case of coccidioidies infection were observed in clinical trials (see section 4.4).
Slovenian: V klinični študiji so opazili en resen primer kriptokoknega meningitisa in en resen primer okužbe s sporo coccidioides (glejte poglavje 4.4).
English: Kyntheum is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Slovenian: Zdravilo Kyntheum je namenjeno za uporabo pod vodstvom in nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze.
English: Animal studies did not show any effects on male and female reproductive organs and on sperm count, motility and morphology (see section 5.3).
Slovenian: Študije na živalih ne kažejo škodljivih učinkov na moške ali ženske reproduktivne organe ter število, gibljivost in morfologijo semenčic (glejte poglavje 5.3).
English: Caution should be exercised when considering the use of Kyntheum in patients with a chronic infection or a history of recurrent infection.
Slovenian: Pri odločanju o uporabi zdravila Kyntheum pri bolnikih s kronično okužbo ali anamnezo ponavljajoče se okužbe je potrebna previdnost.
English: No dose adjustment is recommended.
Slovenian: Prilagajanje odmerkov ni priporočljivo.
English: Then, talk to your doctor about when you should inject the next dose.
Slovenian: Nato se o injiciranju naslednjega odmerka pogovorite z zdravnikom.
English: • If needed, you may store the Kyntheum pre-filled syringe at room temperature up to 25°C for up to 14 days.
Slovenian: • Če je potrebno, lahko z zdravilom Kyntheum napolnjeno injekcijsko brizgo hranite pri sobni temperaturi do 25 °C do 14 dni.
English: In all three clinical trials, examination of age, gender, race, use of prior systemic or photo therapy, use of prior biologics, and biologic failures did not identify differences in response in all key endpoints [PASI 75, PASI 100, sPGA success (0 or 1), and sPGA clear (0)] to Kyntheum among these subgroups.
Slovenian: NRI = imputacija manjkajočih podatkov za bolnike, ki se niso odzvali (Non-responder imputation) V vseh treh kliničnih študijah pregled starosti, spola, rase, uporabe predhodnih sistemskih terapij ali fototerapij, uporabe predhodnih bioloških zdravil ali neuspešnih bioloških terapij med temi podskupinami ni razkril razlik v odzivu na zdravilo Kyntheum pri vseh ključnih končnih opazovanih dogodkih [PASI 75, PASI 100, ocena sPGA uspešno (0 ali 1) in sPGA brez znakov (0)].
English: Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with high affinity to human IL-17RA and blocks the biological activities of the pro-inflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C and IL-17E (also known as IL-25), resulting in inhibition of the inflammation and clinical symptoms associated with psoriasis.
Slovenian: Brodalumab je rekombinantno popolnoma humano monoklonsko imunoglobulinsko protitelo IgG2, ki se z visoko afiniteto veže na humani interlevkin IL-17RA in zavira biološke aktivnosti provnetnih citokinov IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C in IL-17E (znanega tudi kot IL-25), kar zavira vnetje in klinične simptome, povezane s psoriazo.
English: In patients with moderate to severe plaque psoriasis, a single subcutaneous dose of 210 mg brodalumab increased the exposure of midazolam, a CYP3A4/3A5 substrate by 24%.
Slovenian: Pri bolnikih z zmerno do hudo psoriazo v plakih je en subkutani odmerek 210 mg brodalumaba povečal izpostavljenost midazolamu, substratu CYP3A4/3A5, za 24 %.
English: For single use only
Slovenian: Samo za enkratno uporabo.
English: Your doctor will then help you decide whether to stop breast-feeding or stop using Kyntheum.
Slovenian: Skupaj se bosta odločila, ali boste prenehali z dojenjem ali z uporabo zdravila Kyntheum.
English: Renal and hepatic impairment Kyntheum has not been studied in these patient populations.
Slovenian: Zdravila Kyntheum pri teh skupinah bolnikov niso proučevali.
English: If you use more of this medicine than prescribed or take the dose sooner than required, tell your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila Kyntheum, kot bi smeli Če ste uporabili večji odmerek zdravila, kot bi smeli, ali če ste prejeli odmerek prej, kot je bilo predpisano, obvestite zdravnika.
English: • If your doctor decides that you or a caregiver can give the injections at home, you or your caregiver should receive training on the right way to prepare and inject Kyntheum.
Slovenian: • Če se vaš zdravnik odloči, da vi ali vaš negovalec lahko dajeta injekcije doma, se morate vi ali negovalec udeležiti usposabljanja za pravilen način priprave in injiciranja zdravila Kyntheum.
English: • if you have an infection or have any signs of infection listed in Section 4 “Possible Side Effects”
Slovenian: • če prebolevate okužbo ali kažete kakršne koli znake okužb, navedenih v poglavju 4 »Možni neželeni učinki«, • če ste izvedeli, da imate tuberkulozo.
English: - The active substance is brodalumab.
Slovenian: - Učinkovina je brodalumab.
English: EU/1/16/1155/001 Pack containing 2 pre-filled syringes
Slovenian: EU/1/16/1155/001 Pakiranje vsebuje 2 napolnjeni injekcijski brizgi.
English: There is limited data in patients with a history of Crohn's disease.
Slovenian: Na voljo je malo podatkov o bolnikih s Crohnovo boleznijo.
English: Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity.
Slovenian: V kliničnih študijah so bolnikom intravensko dajali odmerke do 700 mg, brez dokazil glede toksičnih učinkov, ki bi omejevali odmerjanje zdravila.
English: As an IgG2 human monoclonal antibody brodalumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Slovenian: Brodalumab je humano monoklonsko protitelo IgG2, zato se predvideva, da se razgradi v manjše peptide in aminokisline prek katabolnih poti, podobno kot endogeni IgG.
English: Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Slovenian: Bolnikom je treba naročiti, naj se posvetujejo z zdravnikom, če opazijo znake ali simptome, ki kažejo na okužbo.
English: Anti-tuberculosis therapy should be considered prior to initiation of Kyntheum in patients with latent tuberculosis.
Slovenian: Pri bolnikih z latentno tuberkulozo je treba pred začetkom zdravljenja z zdravilom Kyntheum razmisliti o anti-tuberkulozni terapiji.
English: IL-17 family cytokine levels have been reported to be increased in psoriasis.
Slovenian: Poročali so, da so ravni citokinov iz družine IL-17 pri psoriazi povišane.
English: Through Week 52, the exposure-adjusted event rates (per 100 patient-years) for infections were 114.6 for patients treated with Kyntheum and 118.1 for patients treated with ustekinumab.
Slovenian: Do 52. tedna zdravljenja je stopnja prilagojene izpostavljenosti (na 100 enot bolnik-leto) za okužbe znašala 114,6 pri bolnikih, ki so bili zdravljeni z zdravilom Kyntheum, in 118,1 pri tistih, ki so bili zdravljeni z ustekinumabom.
English: Within each frequency grouping adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki kategoriji pogostnosti so neželeni učinki zdravila navedeni po padajoči resnosti.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Store in a refrigerator (2°C to 8°C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: • Do not re-use the syringe.
Slovenian: • Ne uporabite brizge znova.
English: After proper training in subcutaneous injection technique, patients may self-inject Kyntheum when deemed appropriate by a physician.
Slovenian: Po ustreznem usposabljanju za subkutano injiciranje si lahko bolniki sami injicirajo zdravilo
English: • redness, pain, itching, bruising, or bleeding at injection site
Slovenian: • rdečina, bolečine, srbenje, modrice ali krvavenje na mestu injiciranja,
English: Patients should be instructed to inject the full amount of Kyntheum according to the instructions provided in the package leaflet.
Slovenian: Bolnikom je treba naročiti, naj si injicirajo celoten odmerek zdravila Kyntheum skladno z navodilom za uporabo.
English: In cynomolgus monkeys, after weekly subcutaneous dosing of brodalumab at dose levels up to 90 mg/kg for 6 months, brodalumab-related effects were limited to injection site reactions and mucocutaneous inflammation that was consistent with pharmacologic modulation of host surveillance to commensal microflora.
Slovenian: Pri opicah Cinomolgus, ki so 6 mesecev prejemale tedenski subkutani odmerek do 90 mg/kg brodalumaba, so bili učinki, povezani z brodalumabom, omejeni na mesto injiciranja in mukokutano vnetje, kar je bilo skladno s farmakološko modulacijo gostiteljskega nadzora komenzalne mikroflore.
English: Population pharmacokinetic modelling predicted that serum brodalumab concentrations dropped below the quantification limit (0.05 mcg/ml) 63 days after discontinuation of steady-state dosing of brodalumab 210 mg administered every 2 weeks in 95% of the patients.
Slovenian: Modeliranje populacijske farmakokinetike je predvidelo, da bodo serumske koncentracije brodalumaba padle pod mejo določljivosti (0,05 mcg/ml) 63 dni po prenehanju odmerjanja 210 mg brodalumaba v stanju dinamičnega ravnovesja vsaka 2 tedna pri 95 % bolnikov.
English: See the detailed “Instructions for Use” that comes with this medicine for information on the right way to store, prepare, and give your injections at home.
Slovenian: Za informacije o pravilnem načinu shranjevanja, priprave in dajanja injekcij doma si oglejte podrobna »Navodila za uporabo«, ki ste jih prejeli s tem zdravilom.
English: Based on population pharmacokinetic modelling, the estimated accumulation ratio after 20 weeks of dosing is 2.5-fold.
Slovenian: Na podlagi modeliranja populacijske farmakokinetike je ocenjena 2,5-kratna stopnja akumulacije po 20 tednih prejemanja odmerka.
English: It is normal to see a drop of liquid at the end of the needle.
Slovenian: Kapljica tekočine na koncu igle ni nič nenavadnega.
English: The exposureadjusted event rates (per 100 patient-years) for serious infections were 1.3 for patients treated with Kyntheum and 1.0 for patients treated with ustekinumab.
Slovenian: Stopnja prilagojene izpostavljenosti (na 100 enot bolnik-leto) za resne okužbe je bila 1,3 pri bolnikih, zdravljenih z zdravilom Kyntheum, in 1,0 pri tistih, ki so bili zdravljeni z ustekinumabom.
English: Fatigue
Slovenian: Utrujenost
English: 1 ml solution contains 140 mg brodalumab.
Slovenian: 1 ml raztopine vsebuje 140 mg brodalumaba.
English: Excipients: proline, glutamate, polysorbate 20 and water for injection.
Slovenian: Pomožne snovi: prolin, glutamat, polisorbat 20 in voda za injekcije.
English: Blocking IL-17RA inhibits IL-17 cytokine-induced responses resulting in normalization of inflammation in the skin.
Slovenian: Zaviranje IL-17RA zavira odzive, ki jih povzroča citokin IL-17, kar normalizira vnetje kože.
English: • muscle pain.
Slovenian: • bolečine v mišicah.
English: Population pharmacokinetic modelling indicated that exposure decreased as body weight increased.
Slovenian: Vpliv telesne mase na farmakokinetiko Modeliranje populacijske farmakokinetike je nakazalo, da se izpostavljenost zmanjša s povečanjem telesne mase.
English: United States
Slovenian: Združene države Amerike
English: Following subcutaneous administrations of 210 mg, brodalumab exhibits non-linear pharmacokinetics typical for a monoclonal antibody that undergoes target-mediated drug disposition.
Slovenian: Izločanje Po subkutanem odmerku 210 mg kaže brodalumab nelinearno farmakokinetiko, značilno za monoklonska protitelesa, ki so podvržena tarčno posredovani uporabnosti zdravila.
English: Instructions for Use: Kyntheum (brodalumab) Solution for injection in pre-filled syringe
Slovenian: Navodila za uporabo: Kyntheum (brodalumab) Raztopina za injiciranje v napolnjeni injekcijski brizgi
English: At Week 12, patients originally randomised to Kyntheum who achieved sPGA success (0 or 1) were re-randomised to receive either placebo or continued Kyntheum at their induction dose.
Slovenian: Bolniki, ki so bili sprva randomizirani za uporabo zdravila Kyntheum in ki so dosegli uspešno oceno sPGA (0 ali 1), so bili v 12. tednu znova randomizirani za prejemanje placeba ali zdravila Kyntheum v indukcijskem odmerku.
English: All three trials included a 12-week placebo-controlled induction phase, a double-blind duration of 52 weeks, and an open-label long-term extension.
Slovenian: Vse tri študije so vključevale 12-tedensko, s placebom nadzorovano indukcijsko fazo, 52-tedensko dvojno slepo obdobje in odprto dolgoročno podaljšanje.
English: How to use Kyntheum
Slovenian: Kako uporabljati zdravilo Kyntheum
English: Do not try to inject yourself until your healthcare provider has shown you the right way to give the injections.
Slovenian: Zdravila Kyntheum si ne poskusite injicirati sami, dokler vam zdravnik ne pokaže pravilnega načina injiciranja.
English: Do not try to inject Kyntheum until you or your caregiver have been shown how to inject Kyntheum by your doctor or nurse.
Slovenian: Zdravila Kyntheum ne injicirajte, dokler vam ali vašemu negovalcu zdravnik ali medicinska sestra ne pokaže, kako injicirate zdravilo Kyntheum.
English: Antibodies to brodalumab developed in 2.7% (122/4461) of patients treated with Kyntheum for up to 52 weeks in psoriasis clinical trials (0.3% of these patients had anti-brodalumab antibodies at baseline).
Slovenian: V kliničnih študijah psoriaze so se pri 2,7 % (122/4.461) bolnikov, ki so prejemali zdravilo Kyntheum, razvila protitelesa proti brodalumabu v obdobju do 52 tednov zdravljenja (0,3 % teh bolnikov je imelo ta protitelesa že na začetku).
English: Solution for injection Multipack: 6 (3 packs of 2) pre-filled syringes
Slovenian: raztopina za injiciranje Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg
English: What Kyntheum looks like and contents of the pack
Slovenian: Izgled zdravila Kyntheum in vsebina pakiranja
English: Serious infections occurred in 0.5% of patients treated with Kyntheum and in 0.2% of patients treated with placebo.
Slovenian: Do resnih okužb je prišlo pri 0,5 % bolnikov, zdravljenih z zdravilom Kyntheum, in pri 0,2 % bolnikov, zdravljenih s placebom.
English: No data are available on the effect of brodalumab on human fertility.
Slovenian: Plodnost Podatkov o vplivu brodalumaba na plodnost pri ljudeh ni na voljo.
English: Kyntheum is available in unit packs containing 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Slovenian: Zdravilo Kyntheum je na voljo v posamičnih pakiranjih, ki vsebujejo 2 napolnjeni injekcijski brizgi, in v skupnem pakiranju, ki vsebuje 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.