natgillin/translations-raw huggingface dataset:
The median tmax values of ustekinumab following a single subcutaneous administration of either 45 mg or 90 mg in patients with psoriasis were comparable to those observed in healthy subjects.
Mediane vrednosti tmax za ustekinumab, po enkratni subkutani injekciji bodisi 45 mg ali 90 mg zdravila, pri bolnikih s psoriazo so bile podobne kot pri zdravih preizkušancih.
The absolute bioavailability of ustekinumab following a single subcutaneous administration was estimated to be 57.2% in patients with psoriasis.
Po enkratni subkutani injekciji je bila absolutna biološka uporabnost ustekinumaba pri bolnikih s psoriazo ocenjena na 57, 2%.
Distribution Median volume of distribution during the terminal phase (Vz) following a single intravenous administration to patients with psoriasis ranged from 57 to 83 ml/ kg.
Porazdelitev Mediana vrednost porazdelitvenega volumna v končni fazi (Vz) po enkratni intravenski injekciji zdravila bolnikom s psoriazo je bila od 57 do 83 ml/ kg.
Metabolism The exact metabolic pathway for ustekinumab is unknown.
Presnova Natančna pot presnove ustekinumaba ni znana.
Elimination Median systemic clearance (CL) following a single intravenous administration to patients with psoriasis ranged from 1.99 to 2.34 ml/ day/ kg.
Izločanje Mediana vrednost sistemskega očistka (CL) ustekinumaba, pri bolnikih s psoriazo, po enkratnem intravenskem injiciranju je bila od 1, 99 do 2, 34 ml/ dan/ kg.
Median half-life (t1/ 2) of ustekinumab was approximately 3 weeks in patients with psoriasis, ranging from 15 to 32 days across all psoriasis studies.
Mediana vrednost razpolovnega časa (t1/ 2) ustekinumaba pri bolnikih s psoriazo pa je znašala približno 3 tedne in se je gibala v razponu od 15 do 32 dni v vseh študijah psoriaze.
In a population pharmacokinetic analysis, the apparent clearance (CL/ F) and apparent volume of distribution (V/ F) were 0.465 l/ day and 15.7 l, respectively, in patients with psoriasis.
V analizi populacijske farmakokinetike pri bolnikih s psoriazo je znašal navidezni očistek zdravila (CL/ F) 0, 465 l/ dan, navidezni porazdelitveni volumen (V/ F) pa 15, 7 l.
The CL/ F of ustekinumab was not impacted by gender.
Spol ni vplival na CL/ F ustekinumaba.
Dose linearity The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately dose- proportional manner after a single intravenous administration at doses ranging from 0.09 mg/ kg to 4.5 mg/ kg or following a single subcutaneous administration at doses ranging from approximately 24 mg to 240 mg in patients with psoriasis.
Linearnost odmerkov Pri bolnikih s psoriazo je sistemska izpostavljenost ustekinumabu (Cmax in AUC) po enkratni intravenski injekciji odmerkov od 0, 09 mg/ kg do 4, 5 mg/ kg ali po enkratni subkutani injekciji odmerkov od približno 24 mg do 240 mg naraščala približno sorazmerno z odmerkom.
Single dose vs. multiple doses Serum concentration-time profiles of ustekinumab were generally predictable after single or multiple subcutaneous dose administrations.
Primerjava enkratnega in večkratnega odmerjanja Krivulje spreminjanja serumske koncentracije ustekinumaba s časom po enkratnem ali večkratnem dajanju subkutane injekcije zdravila so bile na splošno predvidljive.
Steady-state serum concentrations of ustekinumab were achieved by Week 28 after initial subcutaneous doses at Weeks 0 and 4 followed by doses every 12 weeks.
Po dajanju začetnih subkutanih odmerkov v 0. in 4. tednu in kasnejšem prejemanju odmerkov na 12 tednov so bile serumske koncentracije ustekinumaba v stanju dinamičnega ravnovesja dosežene do 28. tedna.
The median steady-state trough concentration ranged from 0.21 µg/ ml to 0.26 µg/ ml (45 mg) and from 0.47 µg/ ml to 0.49 µg/ ml (90 mg).
Mediana vrednost najnižje koncentracije v stanju dinamičnega ravnovesja se je gibala od 0, 21 µg/ ml do 0, 26 µg/ ml (45 mg) in od 0, 47 µg/ ml do 0, 49 µg/ ml (90 mg).
Impact of weight on pharmacokinetics In a population pharmacokinetic analysis, body weight was found to be the most significant covariate affecting the clearance of ustekinumab.
Vpliv telesne mase na farmakokinetiko V analizi populacijske farmakokinetike so ugotovili, da je med drugimi spremenljivkami, ki vplivajo na očistek ustekinumaba, najpomembnejša telesna masa.
The median V/ F in patients with weight > 100 kg was approximately 37% higher as compared to patients with weight ≤ 100 kg.
Mediana vrednost CL/ F pri bolnikih s telesno maso > 100 kg je bila za približno 55% večja kot pri tistih s telesno maso ≤ 100 kg, medtem ko je bila mediana vrednost V/ F za približno 37% večja pri bolnikih s telesno maso > 100 kg kot pri tistih s telesno maso ≤ 100 kg.
The median trough serum concentrations of ustekinumab in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with lower weight (≤ 100 kg) in the 45 mg group.
Mediana vrednost najnižje serumske koncentracije ustekinumaba pri bolnikih z večjo telesno maso (> 100 kg) v skupini za odmerek 90 mg je bila podobna kot pri bolnikih z manjšo telesno maso (≤ 100 kg) v skupini za prejemanje 45 mg odmerka.
Special populations No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Posebne populacije Farmakokinetični podatki o bolnikih z zmanjšanim delovanjem ledvic ali jeter niso na voljo.
In the population pharmacokinetic analysis, there were no indications of an effect of tobacco or alcohol on the pharmacokinetics of ustekinumab.
Pri starostnikih niso bile opravljene specifične študije.
9 5.3 Preclinical safety data
9 V analizi populacijske farmakokinetike ni bilo znakov vpliva tobaka ali alkohola na farmakokinetiko ustekinumaba.
Non-clinical data reveal no special hazard (e. g. organ toxicity) for humans based on studies of repeated-dose toxicity and developmental and reproductive toxicity, including safety pharmacology evaluations.
Neklinični podatki na osnovi študij toksičnosti pri ponavljajočih se odmerkih ter vpliva zdravila na razvoj in sposobnost razmnoževanja, vključno s študijami za ovrednotenje farmakološke varnosti zdravila, niso pokazali nobenega posebnega tveganja za človeka (npr. glede toksičnosti za organe).
No adverse effects on female fertility indices were observed using an analogous antibody to IL-12/ 23 in mice.
Pri miših niso opazili nobenih neželenih učinkov na pokazatelje plodnosti pri samicah pri uporabi analognega protitelesa IL- 12/ 23.
Dose levels in animal studies were up to approximately 45-fold higher than the highest equivalent dose intended to be administered to psoriasis patients and resulted in peak serum concentrations in monkeys that were more than 100-fold higher than observed in humans.
Z omenjenimi odmerki so pri opicah dosegli največje serumske koncentracije, ki so bile več kot 100- krat večje kot pri ljudeh.
Carcinogenicity studies were not performed with ustekinumab due to the lack of appropriate models for an antibody with no cross-reactivity to rodent IL-12/ 23 p40.
Študije kancerogenosti ustekinumaba niso bile opravljene, ker ni ustreznih modelov protiteles brez navzkrižne reaktivnosti na glodalske IL- 12/ 23 p40.
Sucrose L-histidine L-histidine monohydrochloride monohydrate Polysorbate 80 Water for injections
Saharoza, L- histidin, L- histidinijev klorid monohidrat, polisorbat 80, voda za injekcije.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti, zdravila ne smemo mešati z drugimi zdravili.
Store in a refrigerator (2ºC - 8ºC).
Shranjujte v hladilniku (2ºC- 8ºC).
STELARA is supplied as a sterile solution in a single-use type I glass 2 ml vial closed with a coated butyl rubber stopper.
Zdravilo STELARA je na voljo v obliki sterilne raztopine v 2 ml vialah (steklo tipa I) za enkratno uporabo, zaprtih z obloženo zaporko iz butilirane gume.
STELARA is available in a 1 vial pack.
Zdravilo je na voljo v pakiranjih z 1 vialo.
The product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
Zdravila ne smete uporabljati, če je raztopina obarvana ali motna ali če so v njej vidni tuji delci.
Before administration, STELARA should be allowed to reach a comfortable temparature for injection (approximately half an hour).
Pred dajanjem mora zdravilo STELARA doseči temperaturo, ki je primerna za
10 remaining in the vial and the syringe should not be used.
10 injiciranje (približno pol ure na sobni temperaturi).
Detailed instructions for use are provided in the package leaflet.
Zdravilo STELARA ne vsebuje konzervansov, zato neporabljenega zdravila, ki ostane v viali ali brizgi, ne smete uporabiti.
Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg 30 2340 Beerse Belgija
Each vial contains 90 mg ustekinumab in 1 ml.
Ena viala vsebuje 90 mg ustekinumaba v 1 ml raztopine.
4.2 Posology and method of administration
4. 3 Odmerjanje in način uporabe
No dose recommendations can be made.
12 Zdravila STELARA v tej skupini bolnikov niso proučevali, zato ni mogoče dati priporočil za njegovo odmerjanje.
13 Vaccinations It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STELARA.
13 Priporočljivo je, da živih virusnih ali živih bakterijskih cepiv (na primer cepiva z Bacillusom Calmette - Guérin - BCG) ne dajete v času zdravljenja z zdravilom STELARA.
The safety and efficacy of STELARA in combination with other immunosuppressants, including biologics, or phototherapy have not been evaluated (see section 4.4).
Varnosti in učinkovitosti zdravila STELARA v kombinaciji z drugimi imunosupresivi, vključno z biološkimi zdravili ali fototerapijo, še niso ovrednotili (glejte poglavje 4. 4).
14 Lactation It is unknown whether ustekinumab is excreted in human breast milk.
Dojenje Ni znano, ali se ustekinumab izloča v materino mleko pri človeku.
Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with STELARA must be made taking into account the benefit of breast-feeding to the child and the benefit of STELARA therapy to the woman.
14 med zdravljenjem in do 15 tednov po njem preneha dojiti ali naj se raje preneha zdraviti z zdravilom STELARA, ob upoštevanju koristi dojenja za otroka in koristi zdravljenja z zdravilom STELARA za mater.
4.8 Undesirable effects
4. 9 Neželeni učinki
15 Infections In controlled studies of psoriasis patients, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.
Okužbe V nadzorovanih študijah pri bolnikih s psoriazo so bile pogostnosti okužb in resnih okužb pri bolnikih, zdravljenih z ustekinumabom, podobne kot pri tistih, ki so prejemali placebo.
In the placebo-controlled period of clinical studies of psoriasis patients, the rate of infection was 1.39 per patient-year of follow-up in ustekinumab-treated patients, and 1.21 in placebo-treated patients.
15 pri bolnikih, zdravljenih z ustekinumabom, oziroma 1, 21 pri bolnikih, zdravljenih s placebom.
The primary endpoint in both studies was the proportion of patients who achieved PASI 75 response from baseline at Week 12 (see Table 2).
17 Preglednica 2:
17 Table 2 Summary of clinical response in Psoriasis Study 1 (PHOENIX 1) and Psoriasis Study 2 (PHOENIX 2)
Povzetek rezultatov za klinični odziv v 1. študiji psoriaze (PHOENIX 1) in v 2. študiji psoriaze (PHOENIX 2)
18 5.2 Pharmacokinetic properties
18 5. 2 Farmakokinetične lastnosti
19 5.3 Preclinical safety data
19 V analizi populacijske farmakokinetike ni bilo znakov vpliva tobaka ali alkohola na farmakokinetiko ustekinumaba.
6.5 Nature and contents of container
6. 7 Vrsta ovojnine in vsebina
6.6 Special precautions for disposal and other handling
6. 8 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
20 remaining in the vial and the syringe should not be used.
20 injiciranje (približno pol ure na sobni temperaturi).
Manufacturer of the active substance
Ime in naslov izdelovalca biološke zdravilne učinkovine
Louis, MO 63134 USA
Louis, MO 63134 ZDA
Centocor BV Einsteinweg 101 NL-2333 CB Leiden The Netherlands
Centocor BV Einsteinweg 101 NL- 2333 CB Leiden Nizozemska
Summary of Product Characteristics, Section 4.2).
Povzetek glavnih značilnosti zdravila, poglavje 4. 2).
The Marketing authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are experienced to prescribe/ use Stelara are provided with educational materials containing the following:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu zdravila na trg vsi zdravniki in ostalo zdravstveno osebje, ki imajo izkušnje za predpisovanje/ uporabo, prejeli gradiva za izobraževanje o zdravilu Stelara, ki bodo vsebovala:
The objectives of this Health Care Professional educational program will be focused on: • Local Guidance for TB screening (see draft materials in RMP Appendix 1). • The potential risks will be the focus of this EM
Cilji programa za izobraževanje zdravnikov in ostalega zdravstvenega osebja bodo osredotočeni na: • lokalne smernice o presejalnih testih za TB (glejte osnutke gradiv v Prilogi 1 RMP); • potencialna tveganja; • resne okužbe, vključno s salmonelo, TB, in okužbami z mikobakterijami, ki ne povzročajo tuberkuloze; • malignome.
Patient information pack will be focused on: • Potential risks/ side effects as described in the Patient Information Sheet. • Serious infections, including salmonella infections, TB, and non-tuberculous mycobacterial infections. • Malignancies
Gradiva z informacijami za bolnike bodo osredotočena na: • potencialna tveganja/ neželene učinke, kot so opisani v Navodilu za uporabo; • resne okužbe, vključno s salmonelo, TB, in okužbami z mikobakterijami, ki ne povzročajo tuberkuloze; • malignome.
• Appropriate techniques for administration of ustekinumab.
• Ustrezne tehnike za apikacijo ustekinumaba.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 002 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 002 predstavljeni v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
23 Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.6 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
23 Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v 1. 6. različici načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
STELARA 45 mg solution for injection ustekinumab
STELARA 45 mg raztopina za injiciranje ustekinumab
Each vial contains 45 mg of ustekinumab in 0.5 ml.
Ena viala vsebuje 45 mg ustekinumaba v 0, 5 ml raztopine.
Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water for injections.
Pomožne snovi: saharoza, L- histidin, L- histidinijev klorid monohidrat, polisorbat 80, voda za injekcije.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection 45 mg/ 0.5 ml 1 vial
Raztopina za injiciranje 45 mg/ 0, 5 ml 1 viala
METHOD AND ROUTE(S) OF ADMINISTRATION Do not shake.
POSTOPEK IN POT( I) UPORABE ZDRAVILA
Subcutaneous use Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo.
STELARA 45 mg solution for injection ustekinumab SC
STELARA 45 mg raztopina za injiciranje ustekinumab Za subkutano uporabo
VIAL CARTON TEXT (90 mg)
BESEDILO NA ŠKATLI VIALE (90 mg)
STELARA 90 mg solution for injection ustekinumab
STELARA 90 mg raztopina za injiciranje ustekinumab
Each vial contains 90 mg of ustekinumab in 1 ml.
Ena viala vsebuje 90 mg ustekinumaba v 1 ml raztopine.
Solution for injection 90 mg/ 1 ml 1 vial
Raztopina za injiciranje 90 mg/ 1 ml 1 viala
STELARA 90 mg solution for injection ustekinumab SC
STELARA 90 mg raztopina za injiciranje ustekinumab Za subkutano uporabo
33 PACKAGE LEAFLET:
33 NAVODILO ZA UPORABO
What STELARA is and what it is used for 2.
Kaj je zdravilo STELARA in za kaj ga uporabljamo 2.
Before you use STELARA 3.
Kaj morate vedeti, preden boste uporabili zdravilo STELARA 3.
How to use STELARA 4.
Kako uporabljati zdravilo STELARA 4.
How to store STELARA 6.
Shranjevanje zdravila STELARA 6.
WHAT STELARA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO STELARA IN ZA KAJ GA UPORABLJAMO
STELARA belongs to a group of medicines called immunosuppressants (medicines that inhibit your immune system).
Zdravilo STELARA sodi v skupino zdravil, ki jih imenujemo imunosupresivi (zdravila, ki zavirajo imunski sistem).
STELARA contains the active substance ustekinumab, a monoclonal antibody.
Zdravilo STELARA vsebuje učinkovino ustekinumab, ki je monoklonsko protitelo.
STELARA is used to treat moderate to severe plaque psoriasis in patients who cannot use or did not respond to other medicines and phototherapy.
Zdravilo STELARA uporabljamo za zdravljenje zmerne do hude psoriaze s plaki pri bolnikih, ki ne morejo uporabljati ali se niso odzvali na zdravljenje z drugimi zdravili in na fototerapijo.
This disease causes inflammation of skin and nails.
Ta bolezen povzroči vnetje kože in nohtov.
STELARA will reduce the inflammation and other signs of the disease.
Zdravilo STELARA zmanjša vnetje in druge bolezenske znake.
BEFORE YOU USE STELARA
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO STELARA
Do not use STELARA • If you are allergic (hypersensitive) to ustekinumab or to any of the other ingredients of STELARA (listed in section 6 ‘ What STELARA contains’). • If you have an active infection which your doctor considers important (see also below ‘ Take special care with STELARA’).
Ne uporabljajte zdravila STELARA • če ste alergični (preobčutljivi) na ustekinumab ali katerokoli sestavino zdravila STELARA (navedene v poglavju 6, ‘ Kaj vsebuje zdravilo STELARA ’), • če imate aktivno okužbo, ki jo je vaš zdravnik ocenil za pomembno (glejte tudi poglavje ‘ Bodite posebno pozorni pri uporabi zdravila STELARA ’ spodaj).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using STELARA.
Če ste negotovi, ali karkoli od naštetega velja za vas, se posvetujte z zdravnikom ali s farmacevtom, pred uporabo zdravila STELARA.
34 Take special care with STELARA Your doctor will assess your health before treatment.
Bodite posebno pozorni pri uporabi zdravila STELARA Pred začetkom zdravljenja, bo zdravnik ocenil vaše zdravstveno stanje.
Make sure you tell your doctor about any illness you have.
Zdravniku povejte o vseh vaših boleznih.
Check with your doctor before using STELARA if you have: • Infections o You must tell your doctor if you have any kind of infection STELARA may make you less able to fight infections.
Pred uporabo zdravila STELARA, se posvetujte s svojim zdravnikom, če imate: • okužbo o Zdravniku morate povedati, če imate kakršnokoli okužbo.
Some infections could also become serious. o Tell your doctor if you have any signs of infection, even if it is very minor.
Zdravilo STELARA lahko zmanjša vašo sposobnost za boj proti okužbam in bi nekatere okužbe lahko postale tudi resne. o Zdravnika morate obvestiti če imate kakršnekoli znake, tudi če gre za zelo majhno okužbo.
Signs may include fever, feeling tired, cough, flu-like symptoms, diarrhoea, dental problems and burning when urinating.
Če niste prepričani, se nemudoma pogovorite s svojim zdravnikom.
If you are not sure, talk to your doctor straight away o It is particularly important to tell your doctor if you have an infection that will not go away or keeps coming back o Tell your doctor if you have any open cuts or sores – they might get infected.
Še posebej je pomembno, da zdravnika obvestite, če imate okužbo, ki ne mine ali ki se ponavlja. o Zdravniku morate tudi povedati, če imate kakršnokoli vreznino ali rano, ker bi se le- ta lahko o okužila.
o Tuberculosis (TB) Tell your doctor if you have had tuberculosis.
Tuberkuloza (TB) Zdravnika morate obvestiti, če ste imeli kdaj tuberkulozo.
Also tell him or her if you have recently been near anyone who might have tuberculosis Your doctor will examine you for tuberculosis and perform a test to see if you have tuberculosis, before you are given STELARA If your doctor thinks that you are at risk of tuberculosis, you may be given medicines for tuberculosis.
Če zdravnik meni, da obstaja pri vas tveganje za tuberkulozo, vam bo morda predpisal zdravila zanjo.
This will be before you begin treatment with STELARA, and during treatment with STELARA.
Ta boste jemali pred začetkom zdravljenja z zdravilom STELARA in med njim.
• Cancer.
• Rakave bolezni.
Immunosuppressants like STELARA decrease the activity of the immune system.
Imunosupresivi, kot je tudi STELARA, zmanjšujejo delovanje imunskega sistema, kar lahko poveča tveganje za nastanek raka.
Tell your doctor if you have ever had any type of cancer.
Zato morate svojemu zdravniku povedati, če ste imeli kdaj v življenju kakršnokoli vrsto raka.
• Vaccinations.
• Cepljenja.
Tell your doctor if you have recently had or are going to have a vaccine.
Zdravniku povejte, če ste bili pred kratkim cepljeni oziroma če boste cepljeni.
• Other therapies for psoriasis.
• Druga zdravljenja psoriaze.
Tell your doctor if you are receiving any other immunosuppressant or phototherapy (when your body is treated with specific ultraviolet (UV) light) while using STELARA, which may also decrease the activity of your immune system.
Zdravniku povejte, če prejemate katerikoli drug imunosupresiv ali fototerapijo (obsevanje telesa s posebno ultravijolično (UV) svetlobo) med uporabo zdravila STELARA, ki tudi lahko zmanjša aktivnost imunskega sistema.
The combination of these therapies has not been investigated and it may increase the risk of diseases related to a weakened immune system.
Kombinacija teh terapij ni bila preučevana in bi lahko povečala tveganje za bolezni, ki so povezane z oslabljenim imunskim sistemom.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using STELARA.
Če niste gotovi, ali se katera od zgornjih trditev nanaša na vaš primer, se pogovorite s svojim zdravnikom ali farmacevtom, preden začnete uporabljati zdravilo STELARA.
You should not be given certain types of vaccines while on treatment with STELARA.
Med zdravljenjem z zdravilom STELARA vam ne smejo dati določenih cepiv.
The effects of this medicine in pregnant women are not known.
Nosečnost in dojenje Preden boste začeli uporabljati zdravilo STELARA, se pogovorite s svojim zdravnikom: • če ste noseči ali načrtujete nosečnost med jemanjem zdravila STELARA, ker vpliv tega zdravila na nosečnice ni znan.
Your doctor will decide whether you should use this medicine.
Ženske v rodni dobi naj med in še najmanj 15 tednov po uporabi zdravila STELARA za preprečevanje nosečnosti uporabljajo ustrezno kontracepcijo. • če dojite ali načrtujete, da boste med jemanjem zdravila STELARA dojili - v tem primeru bo zdravnik presodil, ali smete jemati to zdravilo.
Driving and using machines It is not known if STELARA can affect the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali lahko zdravilo STELARA vpliva na vašo sposobnost vožnje in upravljanja s stroji.
HOW TO USE STELARA
KAKO UPORABLJATI ZDRAVILO STELARA
Always use STELARA exactly as your doctor has told you.
Pri uporabi zdravila STELARA natančno upoštevajte zdravnikova navodila.