natgillin/translations-raw huggingface dataset:
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 10 (for 2 dose-dispenser cartridges and 2 alcohol wipes) (without bluebox)
Vmesna škatla z večkratnim pakiranjem po 10 (2 odmerna vložka in 2 alkoholna zloženca) (brez blue box)
• Look at the expiry date on the pack and dose tray.
• Preverite rok uporabnosti na pakiranju in podstavku z zdravilom.
Rare fistula (any site)
Splošne težave in spremembe na mestu aplikacije redki fistula (kjerkoli)
Cimziaa 200 mg every 2 weeks N=159
Cimzia 200 mg vsak drugi teden n = 95
The overall percentage of patients with antibodies to Cimzia detectable on at least one occasion up to Week 24 was 4.4% in the AS001 phase III placebo controlled trial in patients with axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis subpopulations).
Pri bolnikih z aksialnim spondiloartritisom (podskupine z ankilozirajočim spondilitisom in neradiografskim aksialnim spondiloartritisom) je bil v fazi III AS001 s placebom nadzorovanega preskušanja celotni delež bolnikov s protitelesi proti zdravilu Cimzia, ki so bila detektirana vsaj enkrat do 24. tedna, 4,4 %.
Medication: dose-dispenser cartridge
Zdravilo: odmerni vložek
MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/001
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 pre-filled syringes and 2 alcohol wipes)
Zunanja škatla (za pakiranje z 2 napolnjenima injekcijskima peresnikoma in 2 alkoholnima zložencema)
Cimzia 200 mg solution for injection in dose-dispenser cartridge certolizumab pegol
Cimzia 200 mg raztopina za injiciranje v odmernem vložku certolizumab pegol
Rare seizure, cranial nerve inflammation, impaired coordination or balance
Bolezni živčevja občasni periferne nevropatije, omotičnost, tremor
MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/005
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/005
• The starting dose for adults with axial spondyloarthritis is 400 mg given at weeks 0, 2 and 4.
• Začetni odmerek za odrasle z aksialnim spondiloartritisom je 400 mg, ki ga bolniki prejmejo na začetku zdravljenja, po dveh in po štirih tednih.
Axial spondyloarthritis Overall Population
Parametri ankilozirajoči spondilitis neradiografski aksialni spondiloartritis aksialni spondiloartritis celotna populacija
Not known multiple sclerosis*, Guillain-Barré syndrome*
Pogostnost Neželeni učinki redki krči, vnetje kranialnega živca, motnje koordinacije ali ravnotežja neznana multipla skleroza*, Guillain-Barréjev sindrom*
Do not use Cimzia after the expiry date which is stated on the pack and dose tray after EXP.
Po preteku datuma, navedenega na pakiranju in na odmernem vložku poleg oznake EXP, zdravila Cimzia ne uporabljajte.
- One or two medication cartridge(s), depending on your prescribed dose - One or two alcohol wipe(s)
• Iz škatlice z zdravilom Cimzia vzemite naslednje pripomočke in jih razporedite po čisti, ravni površini: - eno ali dve napolnjeni injekcijski brizgi, odvisno od predpisanega odmerka - en ali dva alkoholna zloženca
Solution for injection in a pre-filled pen (AutoClicks) 2 AutoClicks pre-filled pens 2 alcohol wipes
raztopina za injiciranje v napolnjenem injekcijskem peresniku (AutoClicks) 2 napolnjena injekcijska peresnika
MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/004
Packs of 2 pre-filled syringes and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes, and a multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes are available.
Na voljo je pakiranje z 2 injekcijskima brizgama in 2 alkoholnima zložencema, večkratno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi brizgami in 6 (3 pakiranja po 2) alkoholnimi zloženci ter večkratno pakiranje z 10 (5 pakiranj po 2) napolnjenimi injekcijskimi brizgami in 10 (5 pakiranj po 2) alkoholnimi zloženci.
Partial remission(c,d)
12. teden 24. teden Delno izboljšanje(c,d)
Solution for injection in dose-dispenser cartridge 2 single-use dose-dispenser cartridges 2 alcohol wipes
raztopina za injiciranje v odmernem vložku 2 odmerna vložka za enkratno uporabo 2 alkoholna zloženca
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 10 (for 2 pre-filled syringes and 2 alcohol wipes) (without bluebox)
Vmesna škatla z večkratnim pakiranjem po 10 (2 napolnjeni injekcijski brizgi in 2 alkoholna zloženca) (brez blue box)
Pack size of 2 pre-filled pens and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) pre-filled pens and 6 (3 packs of 2) alcohol wipes, a multipack of 10 (5 packs of 2) pre-filled pens and 10 (5 packs of 2) alcohol wipes
Na voljo je pakiranje z 2 odmernima vložkoma in 2 alkoholnima zložencema, večkratno pakiranje s 6 (3 pakiranja po 2) odmernimi vložki in 6 (3 pakiranja po 2) alkoholnimi zloženci ter večkratno pakiranje z 10 (5 pakiranj po 2) odmernimi vložki in 10 (5 pakiranj po 2) alkoholnimi zloženci.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/009
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/009
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled pen contains 200 mg certolizumab pegol in one ml.
NAVEDBA ENE ALI VEČ UČINKOVIN En napolnjen injekcijski peresnik vsebuje 200 mg certolizumab pegola v enem ml.
Treatment with Cimzia must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Če se pri bolnikih kongestivno srčno popuščanje pojavi na novo ali se njegovi simptomi poslabšajo, moramo zdravljenje z zdravilom Cimzia prekiniti.
Packs of 2 dose-dispenser cartridges and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) dose-dispenser cartridges and 6 (3 packs of 2) alcohol wipes, and a multipack containing 10 (5 packs of 2) dose-dispenser cartridges and 10 (5 packs of 2) alcohol wipes are available.
Na voljo je pakiranje z 2 napolnjenima injekcijskima peresnikoma in 2 alkoholnima zložencema, večkratno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi peresniki in 6 (3 pakiranja po 2) alkoholnimi zloženci ter večkratno pakiranje z 10 (5 pakiranj po 2) napolnjenimi injekcijskimi peresniki in 10 (5 pakiranj po 2) alkoholnimi zloženci.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/003
• increased blood levels of uric acid
• zvišana koncentracija sečne kisline v krvi
You should not do both.
Ne smete narediti obojega.
These effects can ease your normal daily activities and so improve your quality of life.
Ti učinki lahko olajšajo opravljanje običajnih vsakdanjih dejavnosti in tako izboljšajo kakovost vašega življenja.
All studies included long-term extensions for up to 5 years.
Vse študije so obsegale dolgoročno podaljšanje do 5 let.
Important to open
Pomembno odpreti
• Do not take a double dose to make up for a forgotten tablet.
• Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeno tableto.
• The tablets can be taken with or without food.
• Tablete lahko vzamete s hrano ali brez nje.
Opportunistic infections (excluding tuberculosis)
Oportunistične okužbe (izključujoč tuberkulozo)
• your liver does not work as well as it should
• če vam jetra ne delujejo, kot bi bilo treba.
Campoverde di Aprilia (LT) ITALY
Campoverde di Aprilia (LT) Italija in
The clinical data are currently limited and long-term studies are ongoing.
Kliničnih podatkov je trenutno malo, dolgoročne študije pa še potekajo.
Approximately 97% of drug-related material in milk was parent drug.
Približno 97 % z zdravilom povezanih snovi v mleku je predstavljalo matično zdravilo.
• If you miss a dose, take it as soon as you remember.
• Če izpustite odmerek, ga vzemite, čim se spomnite.
Table 5: Radiographic changes
Preglednica 5: Radiografske spremembe
The most common serious infection was pneumonia.
Najpogostejša resna okužba je bila pljučnica.
• you have had tuberculosis or have been in close contact with someone with tuberculosis.
• če ste imeli tuberkulozo, ali če ste bili v tesnem stiku s kom, ki ima tuberkulozo.
Clinical Response:
Klinični odziv:
Table 4: Response and remission
Preglednica 4: Odziv in remisija
• if you have severe liver problems
• če imate resne težave z jetri.
Component of a multipack, can't be sold separately.
Del multipakiranja, ni za ločeno prodajo.
Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1.
Prekinitev uporabe je lahko potrebna za obvladanje laboratorijskih nepravilnosti, opisanih v preglednici 1.
148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) Italy
148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) Italija
Most of the herpes zoster events involved a single dermatome and were non-serious.
Večina primerov herpesa zostra je zajela en sam dermatom in niso bili resni.
• who have been exposed to tuberculosis
• ki so bili izpostavljeni tuberkulozi,
There was no change in the LDL/HDL ratio.
Razmerje LDL/HDL se ni spremenilo.
• if you have active tuberculosis (TB)
• če imate aktivno tuberkulozo (TB).
ACR Response
Odziv ACR
Laboratory measures and monitoring guidance Laboratory measure
Laboratorijske meritve in smernice za nadzor Laboratorijske meritve
• To help you remember to take RINVOQ, take it at the same time every day.
• Da se boste lažje spomnili vzeti zdravilo RINVOQ, ga vzemite vsak dan ob istem času.
• who have resided or travelled in areas of endemic tuberculosis or endemic mycoses; or
• ki so živeli v predelih ali so potovali v predele endemične tuberkuloze ali endemičnih mikoz, ali
• if you are pregnant (see section Pregnancy, breast-feeding and contraception)
• če ste noseči (glejte poglavje Nosečnost, dojenje in kontracepcija).
Pregnancy RINVOQ must not be used during pregnancy.
Nosečnost Zdravila RINVOQ se ne sme uporabljati med nosečnostjo.
The same information is also available on the following URL: www.rinvoq.eu
Iste informacije so na voljo tudi na naslednjem URL: www.rinvoq.eu
It is very important to talk to your doctor or pharmacist if you are taking any of the following:
Zelo pomembno je, da se posvetujete z zdravnikom ali farmacevtom, če jemljete kaj od naslednjega:
• Morning stiffness
• Jutranja okorelost
• Physical function (HAQ-DI)
• Telesno delovanje (HAQ-DI)
• throat and nose infections
• okužbe žrela in nosu
Most elevations > 5 x ULN were transient and did not require treatment discontinuation.
Večina zvišanj na > 5-krat nad ZNM je bila prehodnih in niso zahtevala prenehanja zdravljenja.
• Swallow the tablet whole with water.
• Tableto zaužijte celo z vodo.
• If you forget your dose for an entire day, just skip the missed dose and take only a single dose as usual the following day.
• Če odmerka niste vzeli že ves dan, preprosto preskočite izpuščeni odmerek in naslednji dan vzemite en sam odmerek, kot po navadi.
Upadacitinib is 52% bound to plasma proteins.
Upadacitinib je 52 % vezan na beljakovine v plazmi.
Durable response rates were observed (with or without MTX), with ACR20/50/70 responses maintained for at least 1 year.
Opažali so trajne deleže odziva (z MTX ali brez njega) in odzivi ACR20/50/70 so se ohranili vsaj 1 leto.
• Radiographic progression (mTSS)
• Radiografsko napredovanje (mTSS)
• if you are allergic to upadacitinib or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na upadacitinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Proportion of patients with no radiographic progressiond
Delež bolnikov brez radiografskega napredovanjad
12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia
12 tednov po začetku zdravljenja, potem pa v skladu z mednarodnimi kliničnimi smernicami za hiperlipidemije.
RINVOQ is to be taken orally once daily with or without food and may be taken at any time of the day.
Zdravilo RINVOQ je treba jemati peroralno enkrat na dan, s hrano ali brez nje; bolnik ga lahko vzame kadar koli tekom dneva.
To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Za poslušanje ali za izvod teh navodil v <Braillovi pisavi>, <velikem tisku> ali <avdio-obliki> se obrnite na lokalnega predstavnika imetnika dovoljenja za promet z zdravilom.
• if you have a severe infection (such as pneumonia or bacterial skin infection)
• če imate kakšno hudo okužbo (na primer pljučnico ali bakterijsko okužbo kože).
Elevations were observed at 2 to 4 weeks of treatment and remained stable with longer-term treatment.
Zvišanja so opažali po 2 do 4 tednih zdravljenja in so med dolgotrajnim zdravljenjem ostala stabilna.
The safety and efficacy of RINVOQ in children and adolescents aged 0 to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila RINVOQ pri otrocih in mladostnikih, mlajših od 18 let, še nista ugotovljeni.
UPA 15mg N 314 317 216 217 221 221 651 651 327 169 164 Week
UPA 15 mg N 314 317 216 217 221 221 651 651 327 169 164 Teden
Mean neutrophil counts decreased over 4 to 8 weeks.
Povprečno število nevtrofilcev se je zmanjšalo v 4 do 8 tednih.
The tests are to check that treatment with RINVOQ is not causing problems.
Namen teh preiskav je preveriti, da vam zdravljenje z zdravilom RINVOQ ne povzroča težav.
The pattern and incidence of elevation in ALT/AST remained stable over time including in long term extension studies.
Vzorec in pojavnost zvišanj ALT/AST sta ostala stabilna skozi čas, vključno z dolgotrajnimi podaljšanimi študijami.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100).
Pogostnost spodaj naštetih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do 1/100).
8017 JV Zwolle NETHERLANDS
8017 JV Zwolle Nizozemska
The following list of adverse reactions is based on experience from registrational clinical studies.
Spodnja preglednica neželenih učinkov temelji na izkušnjah iz registracijskih kliničnih študij.
The effect of upadacitinib on human fertility has not been evaluated.
Vpliva upadacitiniba na plodnost pri človeku niso ovrednotili.
Do not use this medicine after the expiry date which is stated on the blister label and carton after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu nalepki in na škatli poleg oznake "EXP".
Tablets should be swallowed whole and should not be split, crushed, or chewed.
Tablete mora zaužiti cele in jih ne sme lomiti, drobiti ali žvečiti.
The rate of serious infections remained stable with long-term exposure.
Delež resnih okužb je ostal med dolgotrajno izpostavljenostjo stabilen.
• with chronic or recurrent infection
• s kronično ali ponavljajočo se okužbo,
You and your doctor should decide if you will breast-feed or use RINVOQ.
Vi in vaš zdravnik morata odločiti, ali boste dojili ali jemali zdravilo RINVOQ.
Upadacitinib mean terminal elimination half-life ranged from 9 to 14 hours.
Povprečni terminalni eliminacijski razpolovni čas upadacitiniba je segal od 9 do 14 ur.
Each calendar blister contains 7 tablets.
En koledarski pretisni omot vsebuje 7 tablet.
It belongs to a group of medicines called Janus kinase inhibitors, which help reduce inflammation.
Ta spada v skupino zdravil, imenovanih zaviralci Janusove kinaze, ki pomagajo zmanjšati vnetje.
Upadacitinib was not carcinogenic in a 26-week carcinogenicity study in CByB6F1-Tg(HRAS)2Jic transgenic mice.
Upadacitinib ni bil kancerogen v 26-tedenski študiji kancerogenosti pri CByB6F1-Tg (HRAS)2Jic transgenih miših.
Intrinsic factors
Intrinzični dejavniki
• you have heart problems, high blood pressure, or high cholesterol
• če imate težave s srcem, visok krvni tlak ali povišano raven holesterola v krvi.
The MAH shall ensure that in each Member State where RINVOQ is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense or use RINVOQ have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer je zdravilo RINVOQ na trgu, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo RINVOQ, imeli dostop do/prejeli naslednji paket izobraževalnih gradiv:
Upadacitinib partitions similarly between plasma and blood cellular components, as indicated by the blood to plasma ratio of 1.0.
Upadacitinib se med plazmo in krvnimi celičnimi komponentami porazdeli podobno; to se kaže z razmerjem med krvjo in plazmo 1,0.
Upadacitinib should not be initiated in patients with an active, serious infection, including localised infections.
Upadacitiniba se ne sme uvesti bolnikom, ki imajo kakšno aktivno, resno okužbo, vključno z lokaliziranimi okužbami.
• Active tuberculosis (TB) or active serious infections (see section 4.4).
• Aktivna tuberkuloza (TB) ali aktivne resne okužbe (glejte poglavje 4.4).
The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined (see section 4.2 for monitoring guidance).
Vpliv teh zvišanj lipidov na srčno-žilno obolevnost in umrljivost ni ugotovljen (glejte poglavje 4.2 za smernice za nadzor).
As there is a higher incidence of infections in the elderly ≥ 75 years of age, caution should be used when treating this population.
Ker je pri osebah, starih ≥ 75 let, incidenca okužb višja, je pri zdravljenju te populacije potrebna previdnost.
• Instructions for how to access digital HCP information
• Navodila o tem, kako dostopati do digitalnih informacij za zdravstvene delavce.
Patients should be managed according to international clinical guidelines for hyperlipidaemia
Bolnike je treba voditi v skladu z mednarodnimi kliničnimi smernicami za hiperlipidemijo.
Talk to your doctor if you develop a new lesion or any change in the appearance of an area on the skin.
Posvetujte se z zdravnikom, če se vam pojavi kakšna nova sprememba na koži ali če se spremeni videz določenega predela na koži.
In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
V primeru prevelikega odmerjanja je bolnika priporočljivo nadzorovati glede znakov in simptomov neželenih učinkov.
The efficacy and safety of upadacitinib 15 mg once daily was assessed in five Phase 3 randomised, double-blind, multicentre studies in patients with moderately to severely active rheumatoid arthritis and fulfilling the ACR/EULAR 2010 classification criteria (see Table 3).
Učinkovitost in varnost 15 mg upadacitiniba enkrat na dan so ocenili v petih randomiziranih, dvojno slepih, multicentričnih študijah 3. faze pri bolnikih z zmernim do hudim aktivnim revmatoidnim artritisom, ki so izpolnjevali klasifikacijska merila ACR/EULAR 2010 (glejte preglednico 3).
Note: Week 48-data derived from analysis on Full Analysis set (FAS) by randomised group using NonResponder Imputation
Opomba: Podatki v 48. tednu so pridobljeni iz analize niza celotne analize (FAS = Full Analysis set) z randomizirano skupino z uporabo imputacije podatkov bolnikov, ki se niso odzvali
Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient.
Priporočljiv je posvet z zdravnikom, izkušenim na področju zdravljenja TB, kot pomoč pri odločitvi o tem, ali je za posameznega bolnika primerna uvedba protituberkuloznega zdravljenja.
Age, sex, body weight, race, and ethnicity did not have a clinically meaningful effect on upadacitinib exposure.
Starost, spol, telesna masa, rasa in etnična pripadnost niso klinično pomembno vplivali na izpostavljenost upadacitinibu.
Monitoring guidance
Smernice za nadzor
You may get some of the side effects listed in section 4.
Pojavijo se vam lahko nekateri neželeni učinki, navedeni v poglavju 4.
How to open the bottle
Kako odprete plastenko
How to puncture the foil
Kako predrete folijo
Prior to initiating upadacitinib, it is recommended that patients be brought up to date with all immunisations, including prophylactic zoster vaccinations, in agreement with current immunisation guidelines.
Pred uvedbo upadacitiniba je priporočljivo poskrbeti, da imajo bolniki opravljena vsa cepljenja, vključno s profilaktičnim cepljenjem proti zostru, v skladu z veljavnimi smernicami za cepljenja.
• you have had a herpes zoster infection (shingles), because RINVOQ may allow it to come back.
• če ste imeli okužbo s herpesom zostrom (pasovcem), kajti zdravilo RINVOQ lahko omogoči njegovo ponovitev.
RINVOQ works by reducing the activity of an enzyme in the body called ‘Janus kinase'.
Zdravilo RINVOQ deluje tako, da v telesu zmanjša aktivnost encima, imenovanega "Janusova kinaza".
There was a higher rate of serious infections in patients ≥ 75 years of age, although data are limited.
Delež resnih okužb je bil večji pri bolnikih, starih ≥ 75 let, toda podatkov je malo.
Upadacitinib therapy may be resumed once the infection is controlled.
Zdravljenje z upadacitinibom je mogoče znova začeti, ko je okužba obvladana.
In a pre-/postnatal development study in rats, there were no maternal effects, no effects on parturition, lactation or maternal behaviour and no effects on their offspring.
V študiji pred in ponatalnega razvoja pri podganah ni bilo učinkov na samice-matere, ni bilo učinkov na skotitev, dojenje ali vedenje mater in tudi ni bilo učinkov na njihovo potomstvo.
Analyses of erosion and joint space narrowing scores were consistent with the overall scores.
Analize rezultatov erozij in zožitve sklepnih špranj so bile konsistentne s splošnimi rezultati.
The recommended dose is one 15 mg tablet once a day.
Priporočeni odmerek je ena 15-mg tableta enkrat na dan.
This phosphorylation, in turn, modulates gene expression and cellular function.
Fosforilacija nato modulira izražanje genov in celično delovanje.
You should not use RINVOQ while breast-feeding as it is not known if this medicine passes into breast milk.
V obdobju dojenja ne smete uporabljati zdravila RINVOQ, ker ni znano, ali to zdravilo prehaja v materino mleko.
A decision must be made whether to discontinue breast-feeding or to discontinue upadacitinib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z upadacitinibom, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
Upadacitinib has no relevant effects on plasma exposures of ethinylestradiol, levonorgestrel, methotrexate, or medicinal products that are substrates for metabolism by CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6.
Upadacitinib ne vpliva pomembno na plazemsko izpostavljenost etinilestradiolu, levonorgestrelu, metotreksatu ali zdravilom, ki so substrati za presnovo s CYP1A2, CYP2B6, CYP2C9, CYP2C19 ali CYP2D6.
Prior to launch of RINVOQ in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila RINVOQ na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in morebitnimi drugimi vidiki programa.
By reducing the activity of this enzyme, RINVOQ can help to reduce pain, stiffness and swelling in your joints, reduce tiredness and it can slow down damage to the bone and cartilage in your joints.
Z zmanjšanjem aktivnosti tega encima lahko zdravilo RINVOQ pomaga zmanjšati bolečine, okorelost in oteklost sklepov in zmanjšati utrujenost, lahko pa tudi pomaga upočasniti okvaro kosti in hrustanca v sklepih.
Creatine phosphokinase
Kreatin-fosfokinaza