natgillin/translations-raw huggingface dataset:
In each cycle, the dose of Xiapex is injected into the plaque causing the deformity followed by a second injection given 1 to 3 days after the first.
V vsakem ciklu se odmerek zdravila Xiapex injicira v plak, ki povzroča deformacijo, čemur sledi drugi odmerek, ki se injicira od enega do treh dni po prvem.
Xiapex contains a mixture of two ‘collagenases', enzymes that break up collagen.
Zdravilo Xiapex vsebuje mešanico dveh kolagenaz, tj. encimov, ki razgrajujejo kolagen.
Patients received up to 4 treatment cycles, each involving two injections and subsequent modeling procedures, and the effects were measured on follow-up after 1 year.
Bolniki so prejeli do štiri cikle zdravljenja, od katerih je vsak vključeval dve injiciranji in kasnejše postopke oblikovanja penisa, učinke pa so izmerili na kontrolnem pregledu po enem letu.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xiapex.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For patients with Peyronie's disease, Xiapex is given for up to 4 treatment cycles each lasting about 6 weeks.
Bolnikom s Peyroniejevo boleznijo se zdravilo Xiapex daje največ štiri cikle zdravljenja, od katerih vsak traja približno šest tednov.
Peyronie's disease is a condition in which men develop plaques of fibrous, scar-like tissue in their penis, causing it to become abnormally curved, and sometimes leading to pain or difficulty in sexual intercourse.
Peyroniejeva bolezen je bolezen, pri kateri se pri moškem pojavijo plaki v obliki fibroznega brazgotinastega tkiva na penisu, ki se zaradi tega nenormalno ukrivi, kar včasih povzroči bolečine ali težave pri spolnem odnosu.
For more information about treatment with Xiapex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xiapex preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The main measures of effectiveness were the reduction in the abnormal curvature of the penis and the extent to which the condition was bothersome to the patient.
Glavni merili učinkovitosti sta bili zmanjšanje nenormalne ukrivljenosti penisa in ocena, kako moteča je bila bolezen za bolnika.
For Peyronie's disease, Xiapex was compared with placebo in two further studies involving 832 men.
Pri Peyroniejevi bolezni so zdravilo Xiapex primerjali s placebom v dveh dodatnih študijah, v katerih je sodelovalo 832 moških.
Xiapex was also more effective than placebo in treating Peyronie's disease, producing a 38% and 31% improvement in abnormal curvature in the two studies, compared with 21% and 15% respectively for placebo.
Zdravilo Xiapex je bilo učinkovitejše od placeba tudi pri zdravljenju Peyroniejeve bolezni, saj je v obeh študijah izboljšalo nenormalno ukrivljenost za 38 % oziroma 31 % v primerjavi z 21 % oziroma 15 % pri uporabi placeba.
What is the risk associated with Xiapex?
Kakšna tveganja so povezana z zdravilom Xiapex?
For the full list of all side effects and restrictions with Xiapex, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Xiapex glejte navodilo za uporabo.
The cords in the palm of patients with Dupuytren's contracture and the plaques in Peyronie's disease are made of fibres of a protein called collagen.
Vozliči v dlani bolnikov z Dupuytrenovo kontrakturo in plaki pri Peyroniejevi bolezni so iz vlaken beljakovine, imenovane kolagen.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xiapex, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Xiapex was compared with placebo (a dummy treatment) in two main studies involving a total of 374 adult patients with Dupuytren's contracture.
Zdravilo Xiapex so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v katerih je sodelovalo skupno 374 odraslih bolnikov z Dupuytrenovo kontrakturo.
The collagenases in Xiapex are extracted from the bacterium Clostridium histolyticum.
Kolagenazi v zdravilu Xiapex sta pridobljeni iz bakterije Clostridium histolyticum.
Xiapex is used to treat Dupuytren's contracture and Peyronie's disease in adults.
Zdravilo Xiapex se uporablja za zdravljenje Dupuytrenove kontrakture in Peyroniejeve bolezni pri odraslih.
Xiapex is used in patients with plaques that can be felt through the skin and in whom the abnormal curvature of the penis is at least 30 degrees at the start of therapy.
Zdravilo Xiapex se uporablja pri bolnikih, pri katerih je plake mogoče otipati skozi kožo in pri katerih je penis ob začetku zdravljenja nenormalno ukrivljen za vsaj 30 stopinj.
Xiapex is a powder and solvent that are made up into a solution for injection.
Zdravilo Xiapex je prašek in vehikel za pripravo raztopine za injiciranje.
For Dupuytren's contracture, the doctor injects the appropriate dose of Xiapex directly into a cord in the patient's palm.
Za zdravljenje Dupuytrenove kontrakture zdravnik injicira ustrezen odmerek zdravila Xiapex neposredno v vozlič v bolnikovi dlani.
Xiapex must not be used to treat Peyronie's disease if the plaque affects the urethra (the tube that carries urine and semen to the outside).
Zdravilo Xiapex se ne sme uporabljati za zdravljenje Peyroniejeve bolezni, če so plaki prizadeli sečnico (cevko, po kateri se izločajo seč in semenčice).
In the second study the figures were 44% (20 out of 45) for the Xiapex group and 5% (1 out of 21) for the placebo group.
V drugi študiji je bilo v skupini, ki je prejemala zdravilo Xiapex, 44 % (20 od 45) takih bolnikov v primerjavi s 5 % (1 od 21) bolnikov v skupini, ki je prejemala placebo.
The company that markets Xiapex must also ensure that all doctors expected to use the medicine are properly trained on the use of the medicine and experienced in diagnosing and managing Dupuytren's contracture or Peyronie's disease.
Poleg tega mora družba, ki izdeluje zdravilo Xiapex, zagotoviti, da so vsi zdravniki, ki naj bi uporabljali zdravilo, ustrezno usposobljeni za pravilno dajanje zdravila ter da imajo izkušnje z diagnosticiranjem in vodenjem zdravljenja Dupuytrenove kontrakture ali Peyroniejeve bolezni.
Xiapex was shown to be more effective at treating Dupuytren's contracture than placebo.
Zdravilo Xiapex se je pri zdravljenju Dupuytrenove kontrakture izkazalo za učinkovitejše od placeba.
A ‘penile modeling procedure' is then performed by the doctor after a further 1 to 3 days to gently stretch and bend the plaque in the opposite direction to the abnormal curvature.
Zdravnik nato po enem do treh dneh izvede postopek oblikovanja penisa, s katerim nežno raztegne in ukrivi plak v smeri, ki je nasprotna smeri nenormalne ukrivljenosti.
Why has Xiapex been approved?
Zakaj je bilo zdravilo Xiapex odobreno?
It is caused by a thickening of the tissues under the skin of the palm that form ‘cords' pulling down on the fingers.
Povzroča jo zadebelitev podkožnega tkiva na dlani, zaradi katere nastajajo vozliči, ki zategujejo prste.
It contains the active substance collagenase clostridium histolyticum.
Vsebuje zdravilno učinkovino kolagenazo clostridium histolyticum.
Xiapex must be given by a doctor trained in the use of the medicine and experienced in diagnosing and managing Dupuytren's contracture or male genital problems.
Zdravilo Xiapex mora dajati zdravnik, ki je ustrezno usposobljen za pravilno dajanje zdravila in ima izkušnje z diagnosticiranjem in vodenjem zdravljenja Dupuytrenove kontrakture ali težav z moškimi spolovili.
Xiapex is to be used in patients with cords in their palms that are thick enough to be felt through the skin.
Zdravilo Xiapex je namenjeno za uporabo pri bolnikih, pri katerih so vozliči v dlaneh tako veliki, da so otipljivi skozi kožo.
There was also a greater improvement with Xiapex than placebo in patient-reported scores of how bothersome the condition was after treatment.
Pri uporabi zdravila Xiapex so se bolj kot pri uporabi placeba izboljšale tudi ocene bolnikov o tem, kako moteča je bila bolezen po zdravljenju.
Up to 2 cords or 2 affected joints in the same hand can be treated at a time.
Sočasno se lahko zdravita dva vozliča ali prizadeta sklepa.
What is Xiapex used for?
Za kaj se zdravilo Xiapex uporablja?
How has Xiapex been studied?
Kako je bilo zdravilo Xiapex raziskano?
How does Xiapex work?
Kako zdravilo Xiapex deluje?
What is Xiapex?
Kaj je zdravilo Xiapex?
How is Xiapex used?
Kako se zdravilo Xiapex uporablja?
When injected into a cord or a plaque, the collagenases break up the collagen fibres.
Kolagenazi pri injiciranju v vozlič ali plak razgradita kolagenska vlakna.
Date of first authorisation: 10 November 2017
Datum prve odobritve: 10. november 2017
You may also see one or more air bubbles.
Opazite lahko tudi enega ali več zračnih mehurčkov.
No specific studies have been conducted in elderly patients.
Pri starejših bolnikih niso opravili posebnih študij.
Do not warm any other way.
Ne ogrevajte na noben drug način.
Wash your hands well with soap and warm water.
Roke si temeljito umijte z milom in toplo vodo.
Patients were examined at four week intervals for a total of four visits.
Bolnike so pregledovali s 4-tedenskimi intervali na skupno štirih obiskih.
• if you have an active infection, including active tuberculosis
• Če imate aktivno okužbo, vključno z aktivno tuberkulozo.
Human IgGs are known to be excreted in breast milk during the first few days after birth, and decrease to low concentrations soon afterwards; consequently, a risk to the breast-fed infant during this period cannot be excluded.
Znano je, da se IgG pri človeku izločajo v materino mleko v prvih dneh po rojstvu in se kmalu zatem znižajo na majhne koncentracije, zato tveganja za dojenega otroka v tem obdobju ni mogoče izključiti.
The following side effects are all mild to moderate.
Naslednji neželeni učinki so blagi do zmerni.
• if you think you have an infection or have symptoms of an infection (see below under ‘Look out for infections and allergic reactions')
• če menite, da imate okužbo ali simptome okužbe (glejte "Bodite pozorni na okužbe in alergijske reakcije"),
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Zaradi boljše sledljivost bioloških zdravil je treba jasno zabeležiti ime in serijsko številko danega zdravila.
There may be a small amount of blood or liquid at the injection site.
Na mestu injiciranja se lahko pojavi manjša količina krvi ali tekočine.
The key efficacy results for the primary and major secondary study endpoints are shown in Table 2 below.
Najbolj pomembni rezultati za oceno učinkovitosti na osnovi primarnih in glavnih sekundarnih ciljev opazovanja so prikazani spodaj v Preglednici 2.
Percent of Subjects (%)
število bolnikov (%)
Do not remove until you are ready to inject Tremfya (See Step 2).
Odstranite ga šele, ko ste pripravljeni na injiciranje zdravila Tremfya (glejte korak 2).
Clinically important active infections (e.g., active tuberculosis, see section 4.4).
Klinično pomembna aktivna okužba (npr. aktivna tuberkuloza, glejte poglavje 4.4).
No data are available on the response to live or inactive vaccines.
O odzivu na živa oziroma inaktivirana cepiva ni podatkov.
• if you have tuberculosis or have been in close contact with someone with tuberculosis
• če imate tuberkulozo ali ste bili v tesnem stiku z osebo, ki ima tuberkulozo,
It is normal to see a drop of liquid.
Normalno je, da se pri tem pojavi kapljica tekočine.
Injection is complete when the handle is pushed all the way down, you hear a click, and the green body is no longer visible.
Injiciranje je zaključeno, ko je držalo potisnjeno do konca, ko zaslišite klik in ko zeleno telo ni več vidno.
• if you are allergic to guselkumab or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na guselkumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Comparative PASI response rates are presented in Table 6.
Primerjalne stopnje odziva PASI so predstavljene v Preglednici 6.
Place your thumb, index and middle fingers directly under the finger flange, as shown.
Palec, kazalec in sredinec položite tik pod držalo za prste, kot kaže slika.
• After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks.
• Po prvem odmerku boste naslednji odmerek prejeli čez 4 tedne, nadaljne odmerke pa boste prejemali na vsakih 8 tednov.
Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Resna preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Push handle straight down
Držalo potisnite naravnost navzdol
Antidrug antibodies were not associated with lower efficacy or development of injection-site reactions.
Protitelesa proti zdravilu niso bila povezana z zmanjšano učinkovitostjo ali z razvojem reakcij na mestu injiciranja.
• Tremfya should not be used in pregnancy as the effects of this medicine in pregnant women are not known.
• Zdravila Tremfya ne smete uporabljati med nosečnostjo, ker vpliv tega zdravila pri nosečnicah ni znan.
Store in refrigerator at 2° to 8°C.
Shranjujte v hladilniku pri temperaturi od 2°C do 8°C.
Overall skin disease
Celokupno stanje kožne bolezni
This medicine is for single use only.
To zdravilo je namenjeno enkratni uporabi.
For further information on elimination of guselkumab, see section 5.2.
Za več podatkov o izločanju guselkumaba glejte poglavje 5.2.
Tremfya may increase the risk of infection.
Zdravilo Tremfya lahko poveča tveganje za razvoj okužb.
The adverse reactions are classified by MedDRA System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so razvrščeni po organskih sistemih klasifikacije MedDRA in pogostnosti po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The European Medicines Agency has deferred the obligation to submit the results of studies with Tremfya in plaque psoriasis in one or more subsets of the paediatric population (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Tremfya pri psoriazi s plaki za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
• Front of thighs (recommended)
• sprednji del stegen (priporočljivo)
It is important to pinch enough skin to inject under the skin and not into the muscle.
Pomembno je, da naredite dovolj veliko kožno gubo, da boste zdravilo injicirali pod kožo in ne v mišico.
Name and address of the manufacturers of the biological active substance Biogen Inc. (BIIB)
Ime in naslov proizvajalcev biološke učinkovine Biogen Inc. (BIIB)
How much Tremfya is given and for how long Your doctor will decide for how long you need to use Tremfya.
Koliko zdravila Tremfya je treba dajati in kako dolgo Vaš zdravnik bo presodil, kako dolgo boste potrebovali zdravilo Tremfya.
For further instructions on preparation and special precautions for handling, see section 6.6 and the ‘Instructions for use' leaflet.
Za dodatna navodila za pripravo zdravila in posebna opozorila pri ravnanju z zdravilom glejte poglavje 6.6 in priložena "Navodila za injiciranje".
• 1 Sharps container (See Step 3)
• 1 posodo za odstranjevanje ostrih predmetov (glejte korak 3)
Wash hands
Umijte si roke
Concomitant immunosuppressive therapy or phototherapy The safety and efficacy of Tremfya in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Sočasno imunosupresivno zdravljenje ali fototerapija Varnosti in učinkovitosti zdravila Tremfya v kombinaciji z imunosupresivi, vključno z biološkimi zdravili ali fototerapijo, niso ocenili.
This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment.
To navodilo ne nadomešča pogovora o vaši bolezni in zdravljenju z zdravnikom.
The safety and efficacy of Tremfya in children and adolescents below the age of 18 years have not yet been established.
Varnosti in učinkovitosti zdravila Tremfya pri otrocih in mladostnikih, mlajših od 18 let, niso ugotovili.
Week 156
156. teden
The last dose was at week 44 for both treatment groups.
Zadnji odmerek so bolniki obeh skupin prejeli v 44. tednu.
There may be new information.
V navodilih so lahko navedene nove informacije.
It is important not to try to inject yourself until you have been trained by your doctor or nurse.
Pomembno je, da si zdravila ne poskušate injicirati sami, dokler vas tega ne nauči zdravnik ali medicinska sestra.
Before live viral or live bacterial vaccination, treatment with Tremfya should be withheld for at least 12 weeks after the last dose and can be resumed at least 2 weeks after vaccination.
Pred cepljenjem z živimi virusnimi ali bakterijskimi cepivi je treba zdravljenje z zdravilom Tremfya odložiti za najmanj 12 tednov po zadnjem odmerku in ga nato ponovno uvesti najmanj 2 tedna po cepljenju.
Position the pre-filled pen straight onto the skin (about 90 degrees relative to injection site).
Napolnjen injekcijski peresnik postavite navpično na kožo (približno pod kotom 90 stopinj na mesto injiciranja).
If you forget to use Tremfya If you have forgotten to inject a dose of Tremfya, inform your doctor.
Če ste pozabili uporabiti zdravilo Tremfya Če ste si pozabili injicirati odmerek zdravila Tremfya, obvestite zdravnika.
Select from the following areas for your injection:
Izberite med naslednjimi mesti za injiciranje:
Baseline characteristics for randomised patients were similar to those observed in VOYAGE 1 and 2.
Izhodiščne karakteristike so bile pri randomiziranih bolnikih podobne kot tiste opažene v študijah VOYAGE 1 in 2.
Women of childbearing potential should use effective methods of contraception during treatment and for at least 12 weeks after treatment.
Ženske v rodni dobi morajo med zdravljenjem in še najmanj 12 tednov po njem uporabljati učinkovite kontracepcijske metode.
• if you are being treated for an infection
• če se zdravite zaradi okužbe,
In humans, selective blockade of IL-23 was shown to normalize production of these cytokines.
Pri človeku selektivno zaviranje IL-23 dokazano normalizira nastajanje teh citokinov.
Of the patients who developed antidrug antibodies, approximately 7% had antibodies that were classified as neutralizing, which equates to 0.4% of all patients treated with Tremfya.
Med bolniki, pri katerih so se razvila protitelesa proti zdravilu, jih je približno 7% imelo protitelesa, ki so bila opredeljena kot nevtralizacijska, kar ustreza 0,4% vseh bolnikov, ki so prejemali zdravilo Tremfya.
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC16.
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov, oznaka ATC: L04AC16.
Table 1: List of adverse reactions System Organ Class
Preglednica 1:Seznam neželenih učinkov Organski sistem
No mutagenicity or carcinogenicity studies were conducted with guselkumab.
Študij mutagenosti ali kancerogenosti z guselkumabom niso izvajali.
Summary of the safety profile The most common adverse drug reaction (ADR) was upper respiratory infection.
Povzetek varnostnega profila Najpogostejši neželeni učinek so bile okužbe zgornjih dihal.
Of the 1384 plaque psoriasis patients exposed to guselkumab and included in the population pharmacokinetic analysis, 70 patients were 65 years of age or older, including 4 patients who were 75 years of age or older.
Med 1.384 bolniki s psoriazo s plaki, ki so bili izpostavljeni guselkumabu in vključeni v analizo populacijske farmakokinetike, je bilo 70 bolnikov starih 65 let ali več, vključno s 4 bolniki, ki so bili stari 75 let ali več.
EU/1/17/1234/001 1 pre-filled syringe EU/1/17/1234/002 1 pre-filled pen EU/1/17/1234/003 2 pre-filled pens EU/1/17/1234/004 2 pre-filled syringes
EU/1/17/1234/001 1 napolnjena injekcijska brizga EU/1/17/1234/002 1 napolnjen injekcijski peresnik EU/1/17/1234/003 2 napolnjena injekcijska peresnika EU/1/17/1234/004 2 napolnjeni injekcijski brizgi
There are no data from the use of guselkumab in pregnant women.
O uporabi guselkumaba pri nosečnicah ni podatkov.
Population pharmacokinetic analyses indicated there were no apparent changes in CL/F estimate in patients ≥ 65 years of age compared to patients < 65 years of age, suggesting no dose adjustment is needed for elderly patients.
Rezultati analize populacijske farmakokinetike so pokazali, da pri bolnikih, starih 65 let ali več, ni bilo očitnih sprememb ocene navideznega očistka (CL/F) v primerjavi z bolniki, ki so bili stari manj kot 65 let, kar nakazuje, da prilagajanje odmerkov pri starejših bolnikih ni potrebno.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
Efficacy and safety of guselkumab were also investigated in a double-blind study compared to secukinumab.
Učinkovitost in varnost guselkumaba so raziskovali tudi v dvojno slepi študiji in ga primerjali z sekukinumabom.
c -9.7 (6.8)
16. teden c -9,7 (6,8)
Tremfya has not been studied in these patient populations.
Zdravila Tremfya pri teh dveh skupinah bolnikov niso preučevali.
• if you are using, have recently used or might use any other medicines.
• če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo,
A decision should be made whether to discontinue, or abstain from initiating treatment with Tremfya, taking into account the benefit of breast-feeding to the child and the benefit of Tremfya therapy to the woman.
Odločiti se je treba, ali je potrebno prenehati zdravljenje z zdravilom Tremfya oz. ga ne uvesti, ob upoštevanju koristi dojenja za otroka in koristi zdravljenja z zdravilom Tremfya za mater.
Hold syringe body below finger flange.
Telo brizge primite pod oprijemalom za prste.
Do not touch needle or let it touch any surface.
Ne dotikajte se igle in se z njo ne dotikajte drugih površin.
Name and address of the manufacturer responsible for batch release Janssen Biologics B.V.
Ime in naslov proizvajalca, odgovornega za sproščanje serije Janssen Biologics B.V.
The absolute bioavailability of guselkumab following a single 100 mg subcutaneous injection was estimated to be approximately 49% in healthy subjects.
Absolutna biološka razpoložljivost guselkumaba po enkratni 100 mg subkutani injekciji je bila pri zdravih preiskovancih ocenjena na približno 49%.