natgillin/translations-raw huggingface dataset:
Do not use during pregnancy and lactation.Embryotoxic effects (foetal urinary tract malformation) were seen in trials of benazepril (as hydrochloride) with laboratory animals (rats) at maternally nontoxic doses.
Z laboratorijskimi študijami z benazeprilom (kot hidroklorid) na laboratorijskih živalih (podganah) so bili dokazani embriotoksični učinki (deformacija sečil plodu) pri odmerkih, ki niso toksični za mater.
Lot {number}
ŠTEVILKA SERIJE Lot {številka}
Chewable tablet.
FARMACEVTSKA OBLIKA Žvečljive tablete.
Do not use during pregnancy and lactation.Embryotoxic effects (foetal urinary tract malformation) were seen in trials of benazepril with laboratory animals (rats) at maternally non-toxic doses.
Z laboratorijskimi študijami z benazeprilom na laboratorijskih živalih (podganah) so bili dokazani embriotoksični učinki (deformacija sečil plodu) pri odmerkih, ki niso toksični za mater.
Repeated administration of benazepril leads to slight bioaccumulation of benazeprilat, steady state being achieved within few days.
Večkratno dajanje benazeprila vodi do rahle bioakumulacije benazeprilata.
The tablets can be divided into equal halves.
Rjave okusne ovalne žvečljive tablete z zarezo.. Tablete lahko razpolovimo na dva enaka dela.
Lactose monohydrate Cellulose microcrystalline Povidone K30
Celuloza, mikrokristalna
Keep out of the sight and reach of children.
Shranjujte nedosegljivo otrokom.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem.
Reversible prostatic atrophy in entire male dogs treated with spironolactone was noted in a Target Animal Safety study at the recommended dose.
Pri nekastriranih samcih psov zdravljenih s spironolaktonom je pogosto opažena reverzibilna atrofija prostate.
4.2 Indications for use, specifying the target species
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Jih ni.
SPECIAL WARNING(S)
POSEBNA OPOZORILA
Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable tablets for dogs benazepril HCl/spironolactone
Cardalis 2,5 mg/20 mg žvečljive tablete za pse Cardalis 5 mg/40 mg žvečljive tablete za pse Cardalis 10 mg/80 mg žvečljive tablete za pse benazeprilijev HCl/spironolakton
Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable tablets for dogs
NAVODILO ZA UPORABO Cardalis 2,5 mg/20 mg žvečljive tablete za pse Cardalis 5 mg/40 mg žvečljive tablete za pse Cardalis 10 mg/80 mg žvečljive tablete za pse
The bottles are fitted with childproof caps.
Plastenka ima zapiralo varno pred otroki.
Cardalis 10 mg/80 mg chewable tablets
Cardalis 10 mg/80 mg žvečljive tablete
Cardalis 5 mg/40 mg chewable tablets
Cardalis 5 mg/40 mg žvečljive tablete
Chewable tablet
FARMACEVTSKA OBLIKA Žvečljive tablete
Cardalis 2.5 mg/20 mg chewable tablets for dogs Benazepril hydrochloride 2.5 mg, spironolactone 20 mg Cardalis 5 mg/40 mg chewable tablets for dogs Benazepril hydrochloride 5 mg, spironolactone 40 mg Cardalis 10 mg/80 mg chewable tablets for dogs Benazepril hydrochloride 10 mg, spironolactone 80 mg
Cardalis 2,5 mg/20 mg žvečljive tablete za pse Cardalis 5 mg/40 mg žvečljive tablete za pse Cardalis 10 mg/80 mg žvečljive tablete za pse benazeprili HCl/spironolactonum
After coadministration of spironolactone (2 mg/kg bw) and benazepril hydrochloride (0.25 mg/kg bw) the terminal plasma half-lives (t½) were 7 hours and 6 hours for canrenone and 7-α-thiomethylspironolactone respectively.
je bil terminalni razpolovni plazemski čas (t½) 7 ur in 6 ur za kanrenon in 7-α-tiometil-spironolakton.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 1 bottle of 30 tablets
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Plastenka po 30 tablet
BATCH NUMBER
Povidon K30
Pregnancy and lactation
OSKRBE IN UPORABE
Biotransformation
Metabolizem
What measures are being taken to ensure the safe and effective use of Stelara?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Stelara?
The first injection is followed by a further injection four weeks later, and then an injection every 12 weeks.
Prvi injekciji sledi nadaljnja injekcija štiri tedne pozneje, nato pa ena injekcija vsakih 12 tednov.
The European Commission granted a marketing authorisation valid throughout the European Union for Stelara on 16 January 2009.
Evropska komisija je dovoljenje za promet z zdravilom Stelara, veljavno po vsej Evropski uniji, izdala 16. januarja 2009.
The full EPAR for Stelara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Stelara je na voljo na spletni strani agencije:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Most of these effects were considered mild and did not require treatment to be stopped.
Večina teh učinkov je bila blagih in zaradi njih ni bilo treba prekiniti zdravljenja.
Stelara is a medicine used to treat the following diseases:
Stelara je zdravilo za zdravljenje naslednjih obolenj:
EPAR summary for the public
Povzetek EPAR za javnost ustekinumab
This is a summary of the European public assessment report (EPAR) for Stelara.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Stelara.
A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Monoklonsko protitelo je vrsta beljakovine, ki je bila zasnovana tako, da v telesu prepozna posebno strukturo (imenovano antigen) in se veže nanjo.
What benefits of Stelara have been shown in studies?
Kakšne koristi je zdravilo Stelara izkazalo v študijah?
The infusion lasts at least one hour and the dose depends on the patient's bodyweight.
Infundiranje traja najmanj eno uro, odmerek pa je odvisen od bolnikove telesne mase.
Ustekinumab attaches to two cytokines (messenger molecules) in the immune system called interleukin 12 and interleukin 23.
Ustekinumab se veže na dva citokina (sporočilni molekuli) v imunskem sistemu, imenovana interlevkin 12 in interlevkin 23.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Stelara's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Stelara večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The side effects of the medicine were considered tolerable and manageable.
Neželeni učinki zdravila so se šteli za znosne in obvladljive.
What is Stelara and what is it used for?
Kaj je zdravilo Stelara in za kaj se uporablja?
The company subsequently provided the longer-term results of the studies (after 5 years of treatment), and the results of a study comparing Stelara with etanercept (another medicine for psoriasis).
Družba je naknadno predložila dolgoročne rezultate študij (po petih letih zdravljenja) in rezultate študije, v kateri so zdravilo Stelara primerjali z etanerceptom (drugim zdravilom za zdravljenje psoriaze).
Stelara must not be used in patients who have an active infection that the doctor considers important.
Zdravila Stelara ne smejo uporabljati bolniki z aktivno okužbo, ki jo je zdravnik ocenil za resno.
However, patients in some studies had unexpected increases in problems affecting the heart and blood vessels and psychiatric problems such as depression which might be related to Stelara.
Kljub temu se je v nekaterih študijah pri bolnikih pojavil nepričakovan porast težav s srcem in ožiljem ter psihiatričnih težav, kot je depresija, kar bi lahko bilo povezano z uporabo zdravila Stelara.
Other information about Stelara
Druge informacije o zdravilu Stelara
By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.
Ustekinumab z zaviranjem njunega delovanja zmanjšuje dejavnost imunskega sistema in blaži simptome bolezni.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stelara have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Stelara upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Why is Stelara approved?
Zakaj je bilo zdravilo Stelara odobreno?
Stelara is available as a solution for injection (45 and 90 mg) in vials or prefilled syringes and as a concentrate (130 mg) to make a solution for infusion (drip) into a vein.
Zdravilo Stelara je na voljo kot raztopina za injiciranje (45 in 90 mg) v vialah ali napolnjenih injekcijskih brizgah in kot koncentrat (130 mg) za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
What are the risks associated with Stelara?
Kakšna tveganja so povezana z zdravilom Stelara?
It is not intended to provide practical advice on how to use Stelara.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In over half of these patients other treatments for psoriasis had failed or the patients could not receive them.
Pri več kot polovici teh bolnikov druga zdravila za zdravljenje psoriaze niso bila uspešna oziroma jih niso mogli prejemati.
These cytokines are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis and Crohn's disease.
Ta citokina sta udeležena v vnetnih in drugih procesih, ki so pomembni pri psoriazi, psoriatičnem artritisu in Crohnovi bolezni.
• moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin).
• zmerne do hude psoriaze s plaki (bolezni, ki povzroča rdeče, luskaste zaplate na koži).
The most common side effects with Stelara (seen in more than 5% of patients during clinical trials) are headache and nasopharyngitis (inflammation of the nose and throat).
Najpogostejši neželeni učinki zdravila Stelara (opaženi med kliničnimi preskušanji pri več kot 5 % bolnikov) so glavobol in nazofaringitis (vnetje nosu in žrela).
For the full list of restrictions please see the package leaflet.
Za celoten seznam omejitev glejte navodilo za uporabo.
It is used in adults and children above the age of 12 years whose condition has not responded to or who cannot use other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A).
Uporablja se pri odraslih in otrocih, starejših od 12 let, katerih bolezen se ni odzvala na drugo sistemsko zdravljenje psoriaze (zdravljenje, ki deluje na celotno telo), kot je zdravljenje s ciklosporinom, metotreksatom ali PUVA (psoralen in obsevanje z ultravijolično svetlobo A), ali ki tovrstnega zdravljenja ne morejo prejemati.
The most serious side effect reported with Stelara is serious hypersensitivity (allergic reaction).
Najresnejši neželeni učinek, opažen pri uporabi zdravila Stelara, je huda preobčutljivost (alergijska reakcija).
For adults the usual dose is 45 mg, whereas the dose in children depends on bodyweight.
Običajni odmerek za odrasle je 45 mg, odmerek za otroke pa je odvisen od njihove telesne mase.
An additional study involved 110 children with moderate to severe plaque psoriasis aged between 12 and 18 years.
V dodatno študijo je bilo vključenih 110 otrok, starih od 12 do 18 let, z zmerno do hudo psoriazo s plaki.
Some of the patients from the two main studies went on to receive Stelara (injection under the skin) every 8 or 12 weeks, or placebo.
Nekateri bolniki iz teh dveh študij so nadaljevali s prejemanjem bodisi zdravila Stelara (v obliki injekcij v podkožje) vsakih 8 ali 12 tednov bodisi placeba.
For more information about treatment with Stelara, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Stelara preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In the second study the figures were 56% for Stelara and 29% for placebo.
V drugi študiji so rezultati znašali 56 % za zdravilo Stelara in 29 % za placebo.
In Crohn's disease, treatment is started with Stelara concentrate.
Pri Crohnovi bolezni se zdravljenje začne z zdravilom Stelara v obliki koncentrata.
PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet light.
PUVA je vrsta terapije, pri kateri bolniku dajo zdravilo, ki vsebuje učinkovino psoralen, nato pa ga izpostavijo ultravijolični svetlobi.
Stelara may be used alone or combined with methotrexate (a DMARD);
Zdravilo Stelara se lahko uporablja kot samostojno zdravilo ali v kombinaciji z metotreksatom (ki spada med zdravila DMARD);
Stelara can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Stelara is used for.
Predpisovanje in izdaja zdravila Stelara je le na recept, zdravljenje z njim pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se zdravilo Stelara uporablja.
Patients weighing over 100 kg should be given Stelara in 90-mg doses for psoriasis, and this should also be considered for psoriatic arthritis.
Bolnikom, ki tehtajo več kot 100 kg, se zdravilo Stelara pri psoriazi daje v 90-miligramskih odmerkih, o takšnem odmerku pa je treba razmisliti tudi pri bolnikih s psoriatičnim artritisom.
Eight weeks after the first infusion patients should receive 90 mg Stelara by injection under the skin.
Osem tednov po prvem infundiranju morajo bolniki prejeti 90 mg zdravila Stelara v obliki injekcije v podkožje.
Stelara was more effective than placebo at improving the symptoms of plaque psoriasis.
Zdravilo Stelara je bilo pri izboljšanju simptomov psoriaze s plaki učinkovitejše od placeba.
• moderately to severely active Crohn's disease (a disease causing inflammation of the gut) in adults whose condition has not responded well enough to other treatments for Crohn's disease or who cannot receive such treatments.
• zmerne do hude aktivne Crohnove bolezni (bolezni, ki povzroča vnetje črevesa) pri odraslih, katerih bolezen se ni zadosti odzvala na druga zdravila za zdravljenje Crohnove bolezni ali ki tovrstnih zdravil ne morejo prejemati.
For practical information about using Stelara, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Stelara naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Therefore, the CHMP decided to restrict the use of the medicine in moderate to severe plaque psoriasis to patients aged 12 years and above in whom other treatments had failed or who could not receive them.
Odbor CHMP je zato odločil, da se pri zmerni do hudi psoriazi s plaki uporaba zdravila omeji na bolnike, starejše od 12 let, pri katerih drugi načini zdravljenja niso bili uspešni ali niso mogoči.
In Crohn's disease, the effects of Stelara in reducing symptoms in patients in whom other treatments had failed or who could not receive them were considered important, also given the unmet medical need of these patients.
Pri Crohnovi bolezni so bili učinki zdravila Stelara pri zmanjševanju simptomov bolezni pri bolnikih, pri katerih druga zdravljenja niso bila uspešna ali teh niso mogli prejemati, pomembni glede na to, da ni drugih zdravil, primernih za te bolnike.
• active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not responded well enough to other treatments called disease-modifying antirheumatic drugs' (DMARDs).
• aktivnega psoriatičnega artritisa (vnetja sklepov zaradi psoriaze) pri odraslih, katerih bolezen se ni zadostno odzvala na zdravljenje z drugimi vrstami zdravil, imenovanimi protirevmatična zdravila za spreminjanje poteka bolezni (DMARD).
The patient material will also include details of how Stelara should be injected under the skin.
Gradivo za bolnike bo vključevalo tudi podrobne napotke o injiciranju zdravila Stelara v podkožje.
Patients then continue with Stelara given under the skin every 8 or 12 weeks depending on response to treatment.
Dajanje injekcij zdravila Stelara v podkožje se nato ponovi vsakih 8 ali 12 tednov, odvisno od odziva na zdravljenje.
The active substance in Stelara, ustekinumab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Stelara, ustekinumab, je monoklonsko protitelo.
In plaque psoriasis and psoriatic arthritis, Stelara is given as an injection under the skin.
Pri psoriazi s plaki in psoriatičnem artritisu se zdravilo Stelara daje z injiciranjem v podkožje.
The CHMP considered that studies had shown that Stelara was effective in the treatment of adults and children over 12 years of age with moderate to severe plaque psoriasis.
Menil je, da se je zdravilo Stelara v študijah izkazalo za učinkovito pri zdravljenju odraslih in otrok, starejših od 12 let, z zmerno do hudo psoriazo s plaki.
The comparative study showed that Stelara is more effective than etanercept after 12 weeks of treatment.
V primerjalni študiji so ugotovili, da je zdravilo po 12 tednih zdravljenja učinkovitejše od etanercepta.
For adults with psoriatic arthritis who have not responded well to DMARDs the CHMP noted the limited treatments available and considered that Stelara would be of benefit in these patients.
Glede odraslih bolnikov s psoriatičnim artritisom, ki se niso dobro odzvali na zdravljenje z zdravili DMARD, je odbor menil, da so zanje na voljo le omejene možnosti zdravljenja in da bi jim zdravilo Stelara lahko koristilo.
In the treatment of Crohn's disease, Stelara (concentrate for infusion) was compared with placebo in two main studies involving 1,369 patients with moderately to severely active disease.
Pri zdravljenju Crohnove bolezni so zdravilo Stelara (koncentrat za infundiranje) primerjali s placebom v dveh glavnih študijah, v kateri je bilo vključenih 1 369 bolnikov z zmerno do hudo aktivno boleznijo.
After 44 weeks of starting treatment by injection under the skin, 53% of patients on Stelara every 8 weeks and 49% of patients on Stelara every 12 weeks had a significant reduction in symptoms of Crohn's disease, compared with 36% of patients on placebo.
Po 44 tednih prejemanja injekcij v podkožje so se simptomi Crohnove bolezni bistveno zmanjšali pri 53 % bolnikov, ki so prejemali zdravilo Stelara vsakih 8 tednov, in pri 49 % bolnikov, ki so zdravilo Stelara prejemali vsakih 12 tednov, v primerjavi s 36 % bolnikov, ki so prejemali placebo.
In the treatment of active psoriatic arthritis, Stelara was compared with placebo in two main studies involving a total of 927 adults with the condition who did not have an adequate response with previous treatments.
Zdravilo Stelara so pri zdravljenju aktivnega psoriatičnega artritisa primerjali s placebom v dveh glavnih študijah, ki sta vključevali skupno 927 odraslih, ki se niso ustrezno odzvali na predhodna zdravljenja.
For the full list of all side effects reported with Stelara, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Stelara, glejte navodilo za uporabo.
Plaque psoriasis
Psoriaza s plaki
These will focus on the safety of Stelara, particularly the risks of developing tuberculosis, other infections and cancers.
Družba, ki izdeluje zdravilo Stelara, bo zdravstvenemu osebju in bolnikom priskrbela izobraževalno gradivo, ki bo obravnavalo predvsem varnost zdravila, zlasti tveganje za razvoj tuberkuloze, drugih okužb in raka.
How is Stelara used?
Kako se zdravilo Stelara uporablja?
The main measure of effectiveness was the number of patients who ‘responded' to treatment after 12 weeks, meaning that symptom scores improved by 75% or more.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so se po 12 tednih odzvali na zdravljenje, kar pomeni, da so se ocene njihovih simptomov izboljšale za najmanj 75 %.
Looking at the results of the two main studies in adults taken together, around 69% of the patients receiving Stelara responded to treatment after 12 weeks, compared with around 3% of the patients receiving placebo.
Skupni rezultati obeh glavnih študij pri odraslih kažejo, da se je po 12 tednih na zdravljenje odzvalo približno 69 % bolnikov, ki so prejemali zdravilo Stelara, v primerjavi s 3 % bolnikov, ki so prejemali placebo.
The children received placebo or Stelara and the main measure of effectiveness was the number of patients who responded to treatment after 12 weeks as shown by an improvement in symptom scores.
Otroci so prejemali bodisi placebo bodisi zdravilo Stelara, v obeh študijah pa je bilo glavno merilo učinkovitosti število bolnikov, ki so se po 12 tednih odzvali na zdravljenje, kar so ugotavljali na podlagi izboljšanja ocene simptomov.
In the first study, around 34% patients who received Stelara (at a dose calculated based on bodyweight) responded to treatment compared with 21% of patients who were given placebo.
V prvi študiji se je na zdravljenje odzvalo okoli 34 % bolnikov, ki so prejemali zdravilo Stelara (v odmerku, izračunanem na podlagi njihove telesne mase), v primerjavi z 21 % bolnikov, ki so prejemali placebo.
In around 69% of children (25 out of 36) who received Stelara responded, compared with 5% of patients receiving placebo (2 out of 37).
Študija pri otrocih je pokazala, da se je približno 69 %(25 od 36) otrok, ki so prejeli zdravilo Stelara, odzvalo nanj, v primerjavi s 5 % bolnikov (2 od 37), ki so prejemali placebo.
In the first study, around 42% of those given Stelara 45 mg and 50% of those given 90 mg responded, compared with around 23% of those given placebo.
V prvi študiji se je na zdravljenje odzvalo okoli 42 % bolnikov, ki so prejemali 45-miligramski odmerek zdravila, in 50 % tistih, ki so prejemali 90-miligramski odmerek, v primerjavi s 23 % bolnikov, ki so prejemali placebo.
The longer-term results showed that with continuous treatment, the response to Stelara is maintained over 5 years.
Dolgoročni rezultati so pokazali, da se je ob neprekinjenem zdravljenju odziv na zdravilo
How does Stelara work?
Kako zdravilo Stelara deluje?
In both studies the main measure of effectiveness was the number of patients who responded to treatment after 24 weeks as shown by an improvement in symptom scores.
V obeh študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so se po 24 tednih odzvali na zdravljenje, kar so ugotavljali na podlagi izboljšanja ocene simptomov.
In the treatment of moderate to severe plaque psoriasis, Stelara has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,996 adults with the condition.
Zdravilo Stelara so pri zdravljenju zmerne do hude psoriaze s plaki primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v kateri je bilo vključenih skupno 1 996 odraslih bolnikov s to boleznijo.
In both studies the main measure of effectiveness was the number of patients who responded to treatment 6 weeks after the injection as shown by an improvement in symptom scores.
V obeh študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so se po šestih tednih po infundiranju odzvali na zdravljenje, kar so ugotavljali na podlagi izboljšanja ocene simptomov.
In the second study, around 44% of those given either dose of Stelara responded, compared with around 20% of those given placebo.
V drugi študiji se je odzvalo okoli 44 % bolnikov, ki so prejemali enega od obeh odmerkov zdravila Stelara, v primerjavi z okoli 20 % bolnikov, ki so prejemali placebo.
Patients or their caregivers may inject Stelara under the skin once they have been trained, if their doctor thinks that this is appropriate.
Če zdravnik presodi, da je primerno, si lahko bolniki po opravljenem ustreznem usposabljanju zdravilo Stelara v podkožje injicirajo sami ali to naredijo njihovi negovalci.
Stelara contains the active substance ustekinumab.
Zdravilo Stelara vsebuje zdravilno učinkovino ustekinumab.