natgillin/translations-raw huggingface dataset:
The most frequent serious infections reported with upadacitinib included pneumonia and cellulitis (see section 4.8).
Med najpogostejšimi resnimi okužbami, o katerih so poročali med uporabo upadacitiniba, sta bili pljučnica in celulitis (glejte poglavje 4.8).
Tell your doctor if you get a painful skin rash with blisters as these can be signs of shingles
Zdravnika morate obvestiti, če se vam pojavi boleč kožni izpuščaj z mehurji, kajti to so lahko znaki pasovca.
CDAI ≤10 (% of patients)
CDAI ≤ 10 (% bolnikov)
Table 3: Clinical trials summary Study name Population (n) Treatment arms
Ime študije Populacija (n) Terapevtske skupine
Upadacitinib is metabolised mainly by CYP3A4.
Upadacitinib se v glavnem presnavlja s CYP3A4.
• medicines to treat bacterial infections (such as clarithromycin)
• zdravila za zdravljenje bakterijskih okužb (npr. klaritromicin).
The risks and benefits of upadacitinib treatment should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing upadacitinib therapy in patients who develop a malignancy.
Upoštevati je potrebno tveganja in koristi zdravljenja z upadacitinibom, preden takšno zdravljenje začnete pri bolnikih z znano maligno boleznijo (razen uspešno zdravljenega nemelanomskega raka kože), ali ko presojate o nadaljevanju zdravljenja z upadacitinibom pri bolnikih, ki se jim pojavi maligna bolezen.
Following oral administration of upadacitinib prolonged-release formulation, upadacitinib is absorbed with a median Tmax of 2 to 4 hours.
Po peroralni uporabi oblike upadacitiniba s podaljšanim sproščanjem se upadacitinib absorbira z medianim Tmax od 2 do 4 ure.
Do not chew, crush or break the tablet.
Tablet ne grizite, ne drobite in ne lomite.
Mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment has no clinically relevant effect on upadacitinib exposure.
Blaga (Child-Pugh A) in zmerna (Child-Pugh B) okvara jeter ni klinično pomembno vplivala na izpostavljenost upadacitinibu.
Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smart phone.
Podrobne in posodobljene informacije o zdravilu so vam na voljo, če s pametnim telefonom skenirate
Upadacitinib Cmax was similar in subjects with normal and impaired renal function.
Cmax upadacitiniba je bila pri preiskovancih z normalnim in okvarjenim delovanjem ledvic podobna.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle Carton (30 and 90 pack)
PODATKI NA ZUNANJI OVOJNINI Škatla za plastenko (30 in 90 v pakiranju)
Potential for upadacitinib to affect the pharmacokinetics of other medicinal products
Možni vpliv drugih zdravil na farmakokinetiko upadacitiniba
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene - aluminium calendar blisters in packs containing 28 or 98 prolonged-release tablets, or multipacks containing 84 (3 packs of 28) prolongedrelease tablets.
Polivinilklorid/polietilen/poliklorotrifluoroetilen-aluminijski koledarski pretisni omoti v pakiranjih, ki vsebujejo 28 ali 98 tablet s podaljšanim sproščanjem, ali multipakiranjih, ki vsebujejo 84 (3 pakiranja po 28) tablet s podaljšanim sproščanjem.
Table 6: Mean change from baseline in HAQ-DIa,b Study
Preglednica 6: Povprečna sprememba HAQ-DI od izhodiščaa,b
Modified Total Sharps Score, mean change from baseline
Modificirana celotna Sharpova ocena, povprečna sprememba od izhodišča
This is because some medicines may reduce how well RINVOQ works or may increase the risk of getting side effects.
Nekatera zdravila namreč lahko poslabšajo delovanje zdravila RINVOQ ali povečajo tveganje za neželene učinke.
Methotrexate and pH modifying medicinal products (e.g., antacids or proton pump inhibitors) have no effect on upadacitinib plasma exposures.
Metotreksat in zdravila, ki vplivajo na pH (npr. antacidi in zaviralci protonske črpalke), ne vplivajo na plazemsko izpostavljenost upadacitinibu.
Upadacitinib should not be used during breast-feeding.
Upadacitiniba se med obdobjem dojenja ne sme uporabljati.
Turn the cap over and place the cutting tool near the edge of the foil seal.
Obrnite pokrovček in namestite pripomoček za rezanje ob rob zapečatene folije.
If a patient develops herpes zoster, interruption of upadacitinib therapy should be considered until the episode resolves.
Če se bolniku pojavi herpes zoster, je treba razmisliti o prekinitvi zdravljenja z upadacitinibom, dokler ta epizoda ne mine.
HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Plastenke iz HDPE s sušilnim sredstvom in polipropilensko zaporko v škatli, ki vsebuje 30 tablet s podaljšanim sproščanjem.
• General introductory language that the HCP measure contains important information to assist the discussion with patients when prescribing upadacitinib.
• Splošen uvodni del, ki vsebuje pomembne informacije za zdravstvene delavce, ki so v pomoč pri pogovoru z bolniki, katerim zdravnik predpiše upadacitinib.
The patient information pack should contain:
Paket izobraževalnih gradiv za bolnika mora vsebovati:
• Risk of foetal malformation o Language on teratogenicity of upadacitinib in animals o Details on how to reduce the risk of exposure during pregnancy for women of childbearing potential based on the following: upadacitinib is contraindicated during pregnancy, women of childbearing potential should be advised to use effective contraception both during treatment and for 4 weeks after the final dose of upadacitinib treatment, and to advise patients to inform their HCP immediately if they think they could be pregnant or if pregnancy is confirmed.
• Tveganje za malformacije ploda o informacije o teratogenosti upadacitiniba pri živalih, o podrobnejše informacije o tem, kako zmanjšati tveganje izpostavljenosti med nosečnostjo za ženske v rodni dobi na podlagi sledečega: upadacitinib je med nosečnostjo kontraindiciran, ženskam v rodni dobi je treba svetovati uporabo učinkovite kontracepcije med zdravljenjem in še 4 tedne po zadnjem prejetem odmerku upadacitiniba, bolnicam je treba svetovati tudi, da svojega zdravnika nemudoma obvestijo, če mislijo, da so noseče, ali v primeru potrjene nosečnosti.
• increased levels of liver enzymes, shown by blood tests (sign of liver problems)
• zvišanje jetrnih encimov; pokaže se na preiskavah krvi (znak težav z jetri)
• feeling sick in the stomach (nausea)
• slabost v želodcu (siljenje na bruhanje)
The pharmacokinetics of upadacitinib have not yet been evaluated in a paediatric population (see section 4.2).
Farmakokinetike upadacitiniba v pediatrični populaciji še niso ovrednotili (glejte poglavje 4.2).
Moreover, upadacitinib treated patients reported significant improvements in fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) compared to placebo.
Poleg tega so bolniki, zdravljeni z upadacitinibom, poročali o značilnih izboljšanjih glede utrujenosti, merjeni z oceno FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue), v primerjavi z bolniki, ki so prejemali placebo.
• thrush in the mouth (white patches in the mouth)
• glivična okužba v ustih (bele lise v ustih)
If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.
Če se med rutinsko obravnavo bolnika zvišata ALT ali AST in obstaja sum na okvaro jeter zaradi zdravila, je treba zdravljenje z upadacitinibom prekiniti, dokler ta diagnoza ni izključena.
• increase in an enzyme called creatine kinase, shown by blood tests
• zvišanje encima, imenovanega kreatin-kinaza; pokaže se na preiskavah krvi
The above side effects are uncommon (may affect up to 1 in 100 people).
Zgoraj navedeni neželeni učinki so občasni (pojavijo se lahko pri največ 1 od 100 oseb).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology.
Predklinični podatki o varnosti na osnovi običajnih študij farmakološke varnosti ne kažejo posebnega tveganja za človeka.
Inhibition of progression of structural joint damage was assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score, at weeks 24/26 and week 48 in SELECT-EARLY and SELECT-COMPARE.
Zavrtje napredovanja strukturne prizadetosti sklepov so v SELECT-EARLY in SELECT-COMPARE ocenjevali z modificirano celotno Sharpovo oceno (mTSS) in njenimi elementi, oceno erozij in oceno zožitve sklepne špranje po 24/26 tednih in 48 tednih.
If you are breast-feeding or are planning to breast-feed, talk to your doctor before taking this medicine.
Če dojite ali nameravate dojiti, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Treatment with upadacitinib 15 mg resulted in significantly greater inhibition of the progression of structural joint damage compared to placebo in combination with MTX in SELECT-COMPARE and as monotherapy compared to MTX in SELECT-EARLY (Table 5).
Zdravljenje s 15 mg upadacitiniba je doseglo značilno večje zavrtje napredovanja strukturne prizadetosti sklepov kot placebo v kombinaciji z MTX v SELECT-COMPARE in kot monoterapija v primerjavi z MTX v SELECT-EARLY (preglednica 5).
The JAK family of enzymes contains four members, JAK1, JAK2, JAK3 and TYK2 which work in pairs to phosphorylate and activate signal transducers and activators of transcription (STATs).
Družina encimov JAK obsega štiri člane, JAK1, JAK2, JAK3 in TYK2, ki delujejo v parih,
Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management (see section 4.2).
Zdravljenja se ne sme začeti, ali ga je treba začasno prekiniti, če se bolniku med rutinsko obravnavo pojavi AŠN < 1 x 109 celic/l, AŠL < 0,5 x 109 celic/l ali hemoglobin < 8 g/dl (glejte poglavje 4.2).
What RINVOQ looks like and contents of the pack
Izgled zdravila RINVOQ in vsebina pakiranja
Upadacitinib 15 mg treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.
Zvišanje lipidov Zdravljenje s 15 mg upadacitinibom je bilo povezano z zvišanjem vrednosti lipidov, ki je bilo odvisno od odmerka, vključno z zvišanjem celokupnega holesterola, trigliceridov, holesterola LDL in holesterola HDL.
Renal impairment has no clinically relevant effect on upadacitinib exposure.
Okvara ledvic ni klinično pomembno vplivala na izpostavljenost upadacitinibu.
• Risk of serious and opportunistic infections including TB o Language on the risk of infections during treatment with upadacitinib o Details on how to reduce the risk of infection with specific clinical measures (what laboratory parameters should be used to initiate upadacitinib, screening for TB, and getting patients immunised as per local guidelines, and interruption of upadacitinib if an infection develops) o Language on avoidance of live vaccines (i.e., Zostavax) prior to and during upadacitinib treatment o Details to advise patients on signs/symptoms of infection to be aware of, so that patients can seek medical attention quickly.
• Tveganje za resne in oportunistične okužbe, vključno s tuberkulozo o informacije o tveganju za pojav okužb med zdravljenjem z upadacitinibom, o podrobnejše informacije o tem, kako zmanjšati tveganje za pojav okužb s specifičnimi kliničnimi ukrepi (katere laboratorijske parametre je treba upoštevati pri uvedbi zdravljenja z upadacitinibom, presejanje za tuberkulozo in imunizacija bolnikov skladno z lokalnimi smernicami ter prenehanje uporabe upadacitiniba v primeru razvoja okužbe), o informacije o izogibanju uporabe živih cepiv (npr. Zostavax) pred in med zdravljenjem z upadacitinibom, o podrobnejše informacije o svetovanju bolnikom glede znakov/simptomov okužbe, na katere morajo biti pozorni, da lahko hitro poiščejo medicinsko pomoč.
Upadacitinib AUC was 18%, 33%, and 44% higher in subjects with mild (estimated glomerular filtration rate 60 to 89 mL/min/1.73 m2), moderate (estimated glomerular filtration rate 30 to 59 mL/min/1.73 m2), and severe (estimated glomerular filtration rate 15 to 29 mL/min/1.73 m2) renal impairment, respectively, compared to subjects with normal renal function.
V primerjavi s preiskovanci z normalnim delovanjem ledvic je bila AUC upadacitiniba pri preiskovancih z blago okvaro ledvic (ocenjena hitrost glomerularne filtracije od 60 do 89 ml/min/1,73 m2) 18 % večja, z zmerno okvaro ledvic (ocenjena hitrost glomerularne filtracije od 30 do 59 ml/min/1,73 m2) 33 % večja in s hudo okvaro ledvic (ocenjena hitrost glomerularne filtracije od 15 do 29 ml/min/1,73 m2) 44 % večja.
How to store RINVOQ 6.
Shranjevanje zdravila RINVOQ 6.
Treatment with upadacitinib was associated with a small, transient increase in mean ALC from baseline up to Week 36 which gradually returned to at or near baseline levels with continued treatment.
Zdravljenje z upadacitinibom je bilo povezano z majhnim, prehodnim povečanjem povprečnega AŠL od izhodišča do 36. tedna; to povečanje se je med nadaljevanjem zdravljenja vrnilo na izhodiščno raven ali blizu nje.
Your doctor will test you for tuberculosis before starting RINVOQ and may retest during treatment
Zdravnik vam bo pred uvedbo zdravljenja z zdravilom RINVOQ opravil testiranje za tuberkulozo; takšno testiranje vam lahko med zdravljenjem ponovi.
• medicines that affect your immune system (such as azathioprine, ciclosporin and tacrolimus)
• zdravila, ki vplivajo na imunski sistem (npr. azatioprin, ciklosporin in takrolimus).
There are limited data on the use of upadacitinib in subjects with severe renal impairment (see section 5.2).
Podatki o uporabi upadacitiniba pri osebah s hudo okvaro ledvic so omejeni (glejte poglavje 5.2).
Inhibition of IL-6 induced STAT3 and IL-7 induced STAT5 phosphorylation
Zavrtje IL-6 je izzvalo fosforilacijo STAT3, zavrtje IL-7 pa fosforilacijo STAT5.
If you take more RINVOQ than you should
Če ste vzeli večji odmerek zdravila RINVOQ, kot bi smeli
Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).
Velikost pakiranja: 1 plastenka (30 tablet s podaljšanim sproščanjem) ali 3 plastenke (90 tablet s podaljšanim sproščanjem).
There are limited data in patients aged 75 years and older.
Podatki za bolnike, stare 75 let in več, so omejeni.
• Core tablet: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, magnesium stearate.
• Jedro tablete: mikrokristalna celuloza, manitol, vinska kislina, hipromeloza, silicijev dioksid (koloidni, brezvodni), magnezijev stearat.
Cases of bacterial meningitis have been reported in patients receiving upadacitinib.
Pri bolnikih, ki so prejemali upadacitinib, so poročali o primerih bakterijskega meningitisa.
No active metabolites have been identified for upadacitinib.
Aktivnih presnovkov upadacitiniba niso identificirali.
Coadministration with CYP3A4 inducers
Sočasna uporaba z induktorji CYP3A4
Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy, although evidence is limited.
S statinskim zdravljenjem se je zvišani holesterol LDL znižal na vrednosti pred zdravljenjem, toda dokazov je malo.
Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation.
Dejavniki tveganja, ki jih je potrebno upoštevati pri oceni tveganja za GVT/PE pri posameznem bolniku, so višja starost, debelost, GVT/PE v anamnezi, načrtovani večji operativni posegi pri bolniku in dolgotrajna imobilizacija.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with upadacitinib.
Bolnike je treba med zdravljenjem z upadacitinibom in po njem skrbno spremljati glede znakov in simptomov okužbe.
Upadacitinib is contraindicated during pregnancy (see section 4.3).
Upadacitinib je med nosečnostjo kontraindiciran (glejte poglavje 4.3).
Animal studies do not indicate effects with respect to fertility (see section 5.3).
Študije na živalih ne kažejo vplivov na plodnost (glejte poglavje 5.3).
If you forget to take RINVOQ
Če ste pozabili vzeti zdravilo RINVOQ
• Risk of herpes zoster o Language on the risk of herpes zoster during treatment with upadacitinib o Details to advise patients on signs/symptoms of infection to be aware of, so that patients can seek medical attention quickly.
• Tveganje za herpes zoster o informacije o tveganju za herpes zoster med zdravljenjem z upadacitinibom, o podrobnejše informacije o svetovanju bolnikom glede znakov/simptomov okužbe, na katere morajo biti pozorni, da lahko hitro poiščejo medicinsko pomoč.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical studies (see section 4.8).
V kliničnih študijah so poročali o reaktivaciji virusov, vključno s primeri reaktivacije virusa herpesa (npr. herpes zoster) (glejte poglavje 4.8).
Patients who were positive for hepatitis B surface antigen or hepatitis B virus DNA were excluded from clinical studies.
ki so bili pozitivni na plaščne antigene hepatitisa B ali na DNA virusa hepatitisa B, niso bili vključeni v klinične študije.
The primary analysis for each of these studies included all randomised subjects who received at least 1 dose of study drug, and non-responder imputation was used for categorical endpoints.
Primarna analiza vsake od teh študij je obsegala vse randomizirane preiskovance, ki so prejeli vsaj
Upadacitinib plasma exposures are proportional to dose over the therapeutic dose range.
Plazemska izpostavljenost upadacitinibu je v območju terapevtskih odmerkov sorazmerna odmerku.
• cold sores (herpes simplex)
• herpes na ustnicah (herpes simpleks)
No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2).
Prilagoditev odmerka pri bolnikih z blago (Child-Pugh A) ali zmerno (Child-Pugh B) okvaro jeter ni potrebna (glejte poglavje 5.2).
Key outcome measures
Ključne mere izida
Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin and phenytoin), which may lead to reduced therapeutic effect of upadacitinib.
Med izpostavljenostjo močnim induktorjem CYP3A4 (kot sta npr. rifampin in fenitoin) se izpostavljenost upadacitinibu zmanjša in to lahko zmanjša terapevtski učinek upadacitiniba.
RINVOQ is available in packs containing 28 or 98 prolonged-release tablets and in multipacks of 84 comprising 3 cartons, each containing 28 prolonged-release tablets.
Zdravilo RINVOQ je na voljo v pakiranjih, ki vsebujejo 28 ali 98 tablet s podaljšanim sproščanjem, in multipakiranjih s 84 tabletami s podaljšanim sproščanjem; multipakiranja so sestavljena iz 3 kartonskih škatel, od teh vsaka vsebuje 28 tablet s podaljšanim sproščanjem.
Upadacitinib should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.
Upadacitinib je treba previdno uporabljati pri bolnikih, ki kronično prejemajo močne zaviralce CYP3A4.
On background csDMARDs
Ob osnovnih csDMARD
Talk to your doctor or pharmacist before and during treatment with RINVOQ if:
Pred zdravljenjem z zdravilom RINVOQ in med zdravljenjem z njim se posvetujte z zdravnikom ali farmacevtom:
Microcrystalline cellulose Hypromellose Mannitol
Mikrokristalna celuloza Hipromeloza
Upadacitinib had no relevant effect on atorvastatin Cmax or on plasma exposures of ortho-hydroxyatorvastatin (major active metabolite for atorvastatin).
Upadacitinib ni pomembno vplival na Cmax atorvastatina ali plazemsko izpostavljenost ortohidroksiatorvastatinu (glavnemu aktivnemu presnovku atorvastatina).
Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo.
Med zdravljenjem z upadacitinibom je bila pojavnost zvišanja jetrnih encimov večja kot med uporabo placeba.
The recommended dose of upadacitinib is 15 mg once daily.
Odmerjanje Priporočeni odmerek upadacitiniba je 15 mg enkrat na dan.
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code: not yet assigned
Farmakoterapevtska skupina: imunosupresivi, selektivni imunosupresivi.
RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, each pack contains 1 bottle (30 tablet pack) or 3 bottles (90 tablet pack).
Zdravilo RINVOQ je na voljo v plastenkah s sušilnim sredstvom; plastenke vsebujejo 30 tablet s podaljšanim sproščanjem in vsako pakiranje vsebuje 1 plastenko (pakiranje s 30 tabletami) ali 3 plastenke (pakiranje z 90 tabletami).
• Clinical remission (DAS28-CRP)
• Klinična remisija (DAS28-CRP)
Upadacitinib should be used with caution in patients with severe renal impairment.
Upadacitinib je treba pri bolnikih s hudo okvaro ledvic uporabljati previdno.
• Adalimumab 40 mg
• 40 mg adalimumaba
Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis were reported with upadacitinib.
Od oportunističnih okužb so med uporabo upadacitiniba poročali o tuberkulozi, multidermatomskem herpesu zostru, oralni kandidozi/kandidozi požiralnika in o kriptokokozi.
If you have moderate to severe active rheumatoid arthritis, you may first be given other medicines, one of which will usually be methotrexate.
boste morda najprej dobili druga zdravila, od katerih je eno po navadi metotreksat.
In a clinical study, coadministration of upadacitinib with ketoconazole resulted in 70% and 75% increases in upadacitinib Cmax and AUC, respectively.
V klinični študiji je sočasna uporaba upadacitiniba in ketokonazola povečala Cmax upadacitiniba za 70 % in njegovo AUC za 75 %.
Administration of multiple 30 mg once daily doses of upadacitinib (a dose that is twice the recommended upadacitinib dose) to healthy subjects had a limited effect on midazolam (sensitive drug substrate for CYP3A) plasma exposures (26% decrease in midazolam AUC and Cmax), indicating that upadacitinib 30 mg once daily may have a weak induction effect on CYP3A.
Možni vpliv upadacitiniba na farmakokinetiko drugih zdravil Uporaba večkratnih dnevnih odmerkov 30 mg upadacitiniba enkrat na dan (to je odmerek, ki je dvakrat tolikšen kot je priporočeni odmerek upadacitiniba) je pri zdravih osebah malo vplivala na plazemsko izpostavljenost midazolamu (ki je občutljiv substrat CYP3A) (26-odstotno zmanjšanje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of 49 tablets (for the 98 pack)
PODATKI NA ZUNANJI OVOJNINI Notranja škatla z 49 tabletami (za pakiranje z 98 tabletami)
In a human radiolabeled study, unchanged upadacitinib accounted for 79% of the total radioactivity in plasma while the main metabolite (product of monooxidation followed by glucuronidation) accounted for 13% of the total plasma radioactivity.
celotne radioaktivnosti v plazmi, glavni presnovek (nastal z monooksidacijo in nadaljnjo glukuronidacijo) pa 13 % celotne radioaktivnosti v plazmi.
RINVOQ 15 mg prolonged-release tablets are purple, oblong, biconvex tablets imprinted on one side with ‘a15'.
15-mg tablete zdravila RINVOQ s podaljšanim sproščanjem so vijoličaste, podolgovate, na obeh straneh izbočene tablete, ki imajo na eni strani vtisnjeno oznako "a15".
The overall long-term rate of infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies (2,630 patients) was 93.7 events per 100 patient-years.
Celotni dolgoročni delež okužb je bil v skupini s 15 mg upadacitiniba v vseh petih kliničnih študijah 3. faze (2.630 bolnikov) 93,7 dogodka na 100 bolnik-let.
Upadacitinib Cmax was unchanged in subjects with mild hepatic impairment and 43% higher in subjects with moderate hepatic impairment compared to subjects with normal liver function.
Cmax upadacitiniba je bila pri preiskovancih z blago okvaro jeter nespremenjena, pri preiskovancih z zmerno okvaro jeter pa 43 % večja kot pri tistih z normalnim delovanjem jeter.
Foil Cutting Tool - on the cap of the bottle
Pripomoček za rezanje folije - na pokrovčku plastenke