natgillin/translations-raw huggingface dataset:
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Izgled zdravila Osigraft in vsebina pakiranja
You will be monitored by your doctor if there is any medical suspicion that new antibodies have formed.
V kolikor obstaja sum, da je prišlo do nastanka novih protiteles, boste pod nadzorom svojega zdravnika.
Where practical, surgical manipulations to the site should be completed prior to implantation of the product.
Če je možno, končajte kirurške posege na tem mestu pred vsaditvijo zdravila.
The Tibial Nonunion pivotal trial compared Osigraft with autograft, with a primary efficacy endpoint at 9 months post-treatment.
V ključni raziskavi nezraslega zloma golenice so primerjali Osigraft z avtolognim presadkom.
common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data
• občasni (pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov)
3.3 mg of eptotermin alfa
IME ZDRAVILA IN POT(I) UPORABE Osigraft eptotermin alfa
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve: 18.05.2001
White to off-white granular powder.
prašek za suspenzijo za implantacijo bel ali belkast zrnast prašek
These are both normal and do not need to be removed
Oba sta normalna in vam ju ni treba odstraniti.
No reduced efficacy was observed.
Zmanjšane učinkovitosti niso opazili.
The expiry date refers to the last day of that month.
datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca;
• If you have an active infection which your doctor thinks is important.
• če imate aktivno okužbo, ki jo je vaš zdravnik ocenil za pomembno.
Date of first authorisation: 16 January 2009 Date of latest renewal: 19 September 2013
Datum prve odobritve: 16. januar 2009 Datum zadnjega podaljšanja: 19. september 2013
Also tell your doctor if you have recently been near anyone who might have tuberculosis.
Zdravniku povejte tudi, če ste bili pred kratkim v bližini osebe, ki bi lahko imela tuberkulozo.
The safety profiles of the recommended dose and half of the recommended dose were comparable.
Varnostna profila priporočenega odmerka in polovice priporočenega odmerka sta bila primerljiva.
Always have the outer carton of the medicine with you, even if it is empty.
Vedno imejte pri sebi škatlico zdravila, tudi če je prazna.
• Reduce the signs and symptoms of your disease.
• zmanjšanje simptomov in znakov vaše bolezni,
PGA = Physician Global Assessment
PGA = zdravnikova splošna ocena (Physician Global Assessment)
The following doses are usually the same as the starting dose.
Nadaljni odmerki so običajno enaki začetnemu odmerku.
Regulation of CYP450 enzymes
Regulacija encimov CYP450
Children (6-11 years)
Otroci (6-11 let)
Serious outcomes have included respiratory failure and prolonged hospitalisation.
Resni izidi so vključevali odpoved dihanja in podaljšanje hospitalizacije.
CDLQI of 0 or 1 indicates no effect on child's quality of life.
CDLQI 0 ali 1 kažeta, da ni vpliva na otrokovo kakovost življenja.
The key efficacy results are shown in Table 6 below.
Ključni izsledki o učinkovitosti so prikazani v Preglednici 6 spodaj.
It should be administered over at least one hour.
Infundirati ga je treba najmanj eno uro.
Health-related quality of life
Z zdravjem povezana kakovost življenja
If these symptoms occur, appropriate therapy should be instituted.
Če se ti simptomi pojavijo je treba uvesti ustrezno zdravljenje.
If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.
Če zdravnik meni, da obstaja pri vas tveganje za tuberkulozo, vam bo morda predpisal zdravila zanjo.
This leaflet has been written for the person taking the medicine.
To navodilo je napisano za osebe, ki zdravilo uporabljajo.
Chemical and physical in-use stability has been demonstrated for 8 hours at 15-25°C.
Kemična in fizikalna stabilnost pripravljene raztopine je bila dokazana za 8 ur pri temperaturi 1525 °C.
Endoscopic Normalization
Endoskopska normalizacija
Specific studies have not been conducted in patients who had recently received live viral or live bacterial vaccines.
Specifične študije še niso bile opravljene pri bolnikih, ki so pred kratkim prejeli živa virusna ali živa bakterijska cepiva.
The basis for this analysis was that at least 100 patients (> 5% of the studied population) were treated concomitantly with these medicinal products for at least 90% of the study period.
Osnova za to analizo je bila, da so najmanj 100 bolnikov (> 5% preučevane populacije) sočasno zdravili z omenjenimi zdravili najmanj 90% trajanja študije.
Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Ker je na splošno pojavnost okužb v tej populaciji večja, je pri zdravljenju starostnikov potrebna previdnost.
Radiographic Response
Radiografski odziv
Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
Monoklonska protitelesa so beljakovine, ki v telesu prepoznajo točno določene beljakovine in se nanje vežejo.
The syringe is fitted with a passive safety guard.
Brizga je opremljena s pasivnim varnostnim pripomočkom.
• Itching (‘pruritus')
• srbenje (‘pruritus')
If you have a serious allergic reaction, your doctor may decide that you should not use Stelara again.
Če imate hudo alergijsko reakcijo, se vaš zdravnik lahko odloči, da zdravila Stelara ne smete več uporabljati.
UNIFI-I included 961 patients.
V študijo UNIFI-I je bilo vključenih 961 bolnikov.
There are no adequate data from the use of ustekinumab in pregnant women.
Ni zadostnih podatkov o uporabi ustekinumaba pri nosečnicah.
After this, dosing every 12 weeks is recommended.
Nato se priporoča odmerjanje na vsakih 12 tednov.
If not used immediately, in-use storage times and conditions are the responsibility of user.
Če zdravilo ne bo porabljeno takoj, je za čas in pogoje shranjevanja odgovoren uporabnik.
No specific studies have been conducted in elderly patients.
Pri starejših niso bile opravljene specifične študije.
Patients in these studies had a diagnosis of PsA for at least 6 months.
Bolniki v teh preskušanjih so imeli PsA diagnosticiran že najmanj 6 mesecev.
Signs include:
Znaki so:
• After the expiry date which is stated on the label and the carton after ‘EXP'.
• po datumu izteka roka uporabnosti, ki je naveden na viali in na škatli poleg oznake ‘EXP'
Most were considered to be mild and did not necessitate discontinuation of study treatment.
Večina neželenih učinkov je bila zmernih in zaradi njih ni bila potrebna prekinitev zdravljenja v študiji.
Efficacy data were collected and analyzed through week 8 for both studies.
V obeh študijah so podatke o učinkovitosti zbirali in analizirali v 8. tednu.
If necessary, the diluted infusion solution may be stored at room temperature.
Če je potrebno, se lahko razredčena raztopina za infundiranje shranjuje pri sobni temperaturi.
Approximately 50% of patients continued on stable doses of MTX (≤ 25 mg/week).
Približno 50% bolnikov je zdravljenje nadaljevalo s stalnimi odmerki MTX(≤ 25 mg/teden).
* See section 4.4, Systemic and respiratory hypersensitivity reactions.
* glejte poglavje 4.4 Sistemske in dihalne preobčutljivostne reakcije
Before you use Stelara tell your doctor:
Pred začetkom uporabe zdravila Stelara, svojemu zdravniku povejte:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti, zdravila ne smete mešati z drugimi zdravili.
• If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated).
• če veste ali mislite, da je bilo zdravilo morda izpostavljeno skrajnim temperaturam (na primer če je po nesreči zmrznilo ali se segrelo);
In Crohn's disease, if therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.
Če pri Crohnovi bolezni pride do prekinitve zdravljenja, je ponovna uvedba zdravljenja s subkutanim odmerjanjem na vsakih 8 tednov varna in učinkovita.
• Store in a refrigerator (2°C-8°C).
• Shranjujte v hladilniku (2°C-8°C).
Do not use the medicine if it has been shaken strongly.
Zdravila torej ne smete uporabiti, če je bilo močno stresano.
The first study was in 110 patients from 12 to 17 years of age treated for up to 60 weeks and the second study was in 44 patients from 6 to 11 years of age treated for up to 56 weeks.
V prvo študijo so vključili 110 bolnikov, starih od 12 do 17 let, zdravljenih do največ 60 tednov, v drugo pa 44 bolnikov, starih od 6 do 11 let in zdravljenih do največ 56 tednov.
Biotransformation The exact metabolic pathway for ustekinumab is unknown.
Biotransformacija Natančna pot presnove ustekinumaba ni znana.
Concomitant use of immunomodulators did not have a significant impact on ustekinumab disposition.
Sočasna uporaba imunomodulatorjev ni pomembno vplivala na razpoložljivost ustekinumaba.
Improvement in health-related quality of life was generally maintained during the extension through week 92.
Izboljšanje v z zdravjem povezano kakovostjo življenja se je med nadaljevanjem v glavnem ohranilo do 92. tedna.
Your doctor will decide when you should receive your next dose.
Zdravnik se bo odločil kdaj boste prejeli naslednji odmerek.
Other medicines, vaccines and Stelara
Druga zdravila, cepiva in zdravilo Stelara
Immunomodulators and/or corticosteroids may be continued during treatment with STELARA.
Zdravljenje z imunomodulatorji in/ali kortikosteroidi se med zdravljenjem z zdravilom STELARA lahko nadaljuje.
• warm, red and painful skin, or a painful skin rash with blisters
• toplo, rdečo in bolečo kožo ali boleč kožni izpuščaj v obliki mehurčkov
• feeling tired or short of breath; cough which will not go away
• občutek utrujenosti ali težkega dihanja, kašelj, ki ne mine
The improvement was sustained through week 28.
Izboljšanje je bilo dokazano tudi v 28. tednu.
Clinically important, active infection (e.g. active tuberculosis; see section 4.4).
Klinično pomembna, aktivna okužba (npr. aktivna tuberkuloza; glejte poglavje 4.4).
• Improve your physical function.
• za izboljšanje telesne zmogljivosti,
Clinical Remission, week 8
Klinična remisija, 8. teden
Traceability:
Sledljivost:
Anaphylaxis and angioedema have occurred.
Prišlo je do pojava anafilaksije in angioedema.
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, predloženemv modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
The ratio of patients with basal versus squamous cell skin cancers (3:1) is comparable with the ratio expected in the general population (see section 4.4).
Delež bolnikov z bazalnoceličnim karcinomom proti ploščatoceličnim karcinomom kože (3:1) je primerljiv pričakovanemu deležu v splošni populaciji (glejte poglavje 4.4).
Adolescent patients (12-17 years)
Mladostniki (stari 12-17 let)
See ‘Look out for serious side effects' in section 4 for the signs of an allergic reaction.
Glejte 'Bodite pozorni na resne neželene učinke' v poglavju 4 za znake in simptome alergijske reakcije.
In Study 1 previous treatment with anti-tumour necrosis factor (TNF)α agent was not allowed.
V 1. študiji predhodno zdravljenje z zaviralcem tumorske nekroze (TNF-anti-tumour necrosis factor) α ni bilo dovoljeno.
Adults aged 18 years or older
Odrasli, stari 18 let in več
This appearance is not unusual for proteinaceous solutions.
Ta videz ni nenavaden za vodne raztopine beljakovin.
The proportion of patients with a PGA score of cleared (0) or minimal (1) at week 12 was 77.3%.
Delež bolnikov z oceno PGA čisto (0) ali minimalno (1) v 12. tednu je bil 77,3%.
Tell your doctor if you have any kind of infection that will not go away or keeps coming back.
Zdravnika obvestite, če imate okužbo, ki ne mine ali ki se ponavlja.
• Do not rub the skin at the injection site.
• Ne drgnite kože na mestu injiciranja.
The most frequently observed malignancies, other than non-melanoma skin cancer, were prostate, colorectal, melanoma and breast cancers.
Najpogosteje opaženi malignomi, razen nemelanomskega kožnega raka, so bili rak prostate, kolorektalni rak, melanom in rak dojk.
• If you have ever had an allergic reaction to latex or Stelara injection - the container of this medicinal product contains latex rubber, which may cause severe allergic reactions in people who are sensitive to latex.
• če ste kdaj imeli alergijsko reakcijo na latex ali injekcijo zdravila Stelara - vsebnik tega zdravila vsebuje pokrovček iz lateksa, ki lahko povzroči hude alergijske reakcije pri ljudeh, ki so nanj občutljivi.
• If you have or have had a recent infection.
• če imate ali ste nedavno imeli okužbo.
In the population pharmacokinetic analysis, there were no indications of an effect of tobacco or alcohol on the pharmacokinetics of ustekinumab.
V analizi populacijske farmakokinetike ni bilo znakov vpliva tobaka ali alkohola na farmakokinetiko ustekinumaba.
• A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis)
• spremembe v psoriazi z rdečino in novimi, rumenimi ali belimi mehurji na koži, ki jih včasih spremlja vročina (pustularna psoriaza)
CDLQI of 0 or 1
CDLQI 0 ali 1
Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections.
Ustekinumab lahko poveča tveganje za nastanek okužb in vodi do reaktivacije latentnih okužb.
Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis)
Podobni simptomi se včasih razvijejo kot spontana sprememba oblike psoriatičnih simptomov (eritrodermična psoriaza).
Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy.
Imunosupresivna zdravila, kot je ustekinumab, lahko povečajo tveganje za nastanek malignomov.
• the solution is not frozen.
• da ni zamrznjena.
The solution may contain a few small translucent or white particles of protein.
Raztopina lahko vsebuje nekaj majhnih, prosojnih ali belih beljakovinskih delcev.
The adverse reactions are classified by 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 in po pogostnosti z upoštevanjem naslednjega dogovora: 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), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Improvement has been reported after discontinuation of ustekinumab and also, in some cases, administration of corticosteroids.
O izboljšanju so poročali po prekinitvi zdravljenja in v nekaterih primerih po odmerjanju kortikosteroidov.
Stelara may make you less able to fight infections, and some infections could become serious.
Zdravilo Stelara lahko zmanjša vašo sposobnost za boj proti okužbam in nekatere okužbe lahko postanejo resne.
This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
To je treba upoštevati pri bolnikih na dieti z nadzorovanim vnosom natrija (glejte poglavje 6.6).
The right dose for you will depend on your body weight at the time each dose is given.
Pravi odmerek za vas je odvisen od vaše telesne mase v času odmerka.
Fertility The effect of ustekinumab on human fertility has not been evaluated (see section 5.3).
Plodnost Vpliva ustekinumaba na plodnost pri ljudeh niso ovrednotili (glejte poglavje 5.3).
• If you are taking, have recently taken or might take any other medicines.
• če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo,
Similar results were obtained from a confirmatory population pharmacokinetic analysis using data from patients with psoriatic arthritis.
Podobne rezultate je pokazala potrditvena populacijska farmakokinetična analiza, kjer so uporabili podatke bolnikov s psoriatičnim artritisom.
Elderly (≥ 65 years) No dose adjustment is needed for elderly patients (see section 4.4).
Starejši (≥ 65 let) Pri starejših ni potrebno prilagajati odmerkov (glejte poglavje 4.4).
Prepare the injection site
Pripravite mesto injiciranja
Uncommon: Depression
Občasni: depresija
ACR 20, 50 and 70 responses continued to improve or were maintained through week 52 (PsA Study 1 and 2) and week 100 (PsA Study 1).
Odzivi ACR 20, 50 in 70 so se izboljševali ali se ohranili do 52. tedna (1. in 2. študija PsA) in do 100. tedna (1. študija PsA).
Before live viral or live bacterial vaccination, treatment with STELARA should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination.
Pred cepljenjem z živimi virusnimi ali živimi bakterijskimi cepivi je treba zdravljenje z zdravilom STELARA odložiti za najmanj 15 tednov po zadnjem odmerku in ga lahko ponovno uvedete šele najmanj 2 tedna po cepljenju.
• If you ever had an allergic reaction to Stelara.
• če ste imeli kdaj alergijsko reakcijo na zdravilo Stelara.
Volume of injection (mL)
Volumen raztopine (ml)
STELARA does not contain preservatives; therefore any unused medicinal product remaining in the vial and the syringe should not be used.
Zdravilo STELARA ne vsebuje konzervansov, zato neporabljenega zdravila, ki ostane v viali ali brizgi, ne smete uporabiti.
Patients with PASI ≥ 12, PGA ≥ 3 and BSA involvement of at least 10%, who were candidates for systemic therapy or phototherapy, were eligible for the study.
Bolniki, ki so imeli PASI ≥ 12, PGA ≥ 3 in BSA najmanj 10% ter so bili kandidati za sistemsko terapijo ali fototerapijo, so bili primerni za vključitev v študijo.
Common: Pruritus
Pogosti: pruritus
If you do not respond well enough to these medicines, you may be given Stelara to:
Če se nanje ne boste zadostno odzvali, boste prejeli zdravilo Stelara za:
• Do not touch the needle guard activation clips (as indicated by asterisks * in Figure 1) to prevent prematurely covering the needle with the needle guard.
• Ne dotikajte se aktivacijskih nastavkov ščitnika igle (ki sta označena z zvezdico na Sliki 1), da ne bi prišlo do prezgodnjega prekritja igle s ščitnikom igle.
It is not known if ustekinumab is absorbed systemically after ingestion.
Ni znano, ali se ustekinumab sistemsko absorbira po zaužitju.
Prescribers should consult the Summary of Product Characteristics for the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Zdravniki morajo prebrati povzetek glavnih značilnosti posameznega cepiva, v katerih bodo našli tudi dodatne informacije in smernice o sočasni uporabi imunosupresivnih zdravil po cepljenju.
After the injection:
Po injiciranju:
This will let the liquid come to a comfortable temperature for injection (room temperature).
Tako se bo tekočina segrela na temperaturo, ki je primerna za injiciranje (sobna temperatura).
• Stelara 130 mg concentrate for solution for infusion is given in a hospital or clinic and patients should not need to store or handle it.
• Zdravilo Stelara 130 mg koncentrat za raztopino za infundiranje boste prejeli v bolnišnici ali kliniki in vam ga ne bo treba shranjevati ali z njim rokovati.
A pre-specified integrated analysis combining data from 927 subjects in both PsA Study 1 and 2 was performed.
Izvedena je bila vnaprej določena analiza, sestavljena iz podatkov 927 bolnikov iz 1. in 2. študije PsA.
Choose and prepare the injection site:
Izberite in pripravite mesto injiciranja:
• Do not remove the stopper
• Zamaška ne odstranite.
The results of an in vitro study do not suggest the need for dose adjustments in patients who are receiving concomitant CYP450 substrates (see section 5.2).
Rezultati študij in vitro ne kažejo potrebe po prilagajanju odmerka pri bolnikih, ki sočasno prejemajo substrate encima CYP450 (glejte poglavje 5.2).
The incidence of malignancies reported in ustekinumab-treated patients was comparable to the incidence expected in the general population (standardised incidence ratio = 0.93 [95% confidence interval: 0.71, 1.20], adjusted for age, gender and race).
Pogostnost malignomov, poročanih pri bolnikih, zdravljenih z ustekinumabom, je bila podobna pričakovani pogostnosti v splošni populaciji (standardiziran količnik incidence = 0,93 [95% interval zaupanja: 0,71; 1,20], prilagojen za starost, spol in raso).
• For instructions on how to inject Stelara, see ‘Instructions for administration' at the end of this leaflet.
• Za dodatne informacije o injiciranju zdravila Stelara glejte poglavje ‘Navodilo za injiciranje zdravila' na koncu tega navodila.
Children weighing less than 60 kg need a dose lower than 45 mg. Make sure you know the proper amount (volume) to remove from the vial and type of syringe needed for dosing.
Odmerek pri otrocih, ki tehtajo manj kot 60 kg, je manjši od 45 mg. Preverite, da imate brizgo ustrezne velikosti, s katero boste iz viale izvlekli potrebno količino (volumen) zdravila za odmerjanje.
Before administration, STELARA should be allowed to reach room temperature (approximately half an hour).
Pred dajanjem mora zdravilo STELARA doseči sobno temperaturo (približno pol ure na sobni temperaturi).
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately.
Z mikrobiološkega stališča je treba raztopino uporabiti takoj, razen če postopek redčenja izključuje tveganje za kontaminacijo z mikrobi.
Use a new needle and syringe for each injection.
Za vsako injekcijo morate uporabiti novo iglo in brizgo.
Patients or their caregivers should be instructed to inject the prescribed amount of STELARA according to the directions provided in the package leaflet.
Bolnikom ali njihovim skrbnikom naročite, naj si injicirajo predpisano količino zdravila STELARA v skladu z navodilom za uporabo.
A beneficial effect was also observed in induction in patients who failed at least one prior TNFα antagonist therapy and vedolizumab, however the number of patients in this subgroup was too small to draw definitive conclusions about the beneficial effect in this group during maintenance.
Ugoden učinek so opazili tudi pri indukcijskem zdravljenju bolnikov z neuspešnim predhodnim zdravljenjem z najmanj enim od zaviralcev TNFα in vedolizumabom, vendar je bilo število bolnikov v tej podskupini premajhno, da bi lahko sprejeli dokončne zaključke o ugodnih učinkih v času vzdrževalnega zdravljenja pri tej skupini bolnikov.
Dosing frequency adjustment
Prilagajanje pogostnosti odmerjanja
Stelara belongs to a group of medicines called ‘immunosuppressants'.
Zdravilo Stelara sodi v skupino zdravil, ki jih imenujemo ‘imunosupresivi'.
Stelara can cause serious side effects, including allergic reactions and infections.
Zdravilo Stelara lahko povzroči resne neželene učinke, vključno z alergijskimi reakcijami in okužbami.
To calculate the volume of injection (mL) for patients < 60 kg, use the following formula: body weight (kg) x 0.0083 (mL/kg) or see Table 2.
Za izračun volumna raztopine (ml) pri bolnikih s telesno maso < 60 kg uporabite naslednjo formulo: telesna masa (kg) x 0,0083 (ml/kg) ali glejte Preglednico 2.
Stelara will reduce the inflammation and other signs of the disease.
Zdravilo Stelara zmanjša vnetje in druge bolezenske znake.
• If you have or have had a recent infection or if you have any abnormal skin openings (fistulae).
• če imate ali ste nedavno imeli okužbo ali nenormalne odprtine na koži (fistule).