FrancophonIA/ELRC3.0 huggingface dataset:
English: Using paracetamol or ibuprofen (anti-inflammatory medicines) shortly after Zoledronic acid Teva Pharma can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion.
Estonian: Paratsetamooli või ibuprofeeni (põletikuvastased ravimid) kasutamine lühiajaliselt pärast ravimi Zoledronic acid Teva Pharma manustamist võib vähendada sümptomeid, nagu palavik, lihasevalu, gripilaadsed sümptomid, liigesevalu ja peavalu, infusioonile järgneva kolme ööpäeva jooksul.
English: A risk management plan has been developed to ensure that Zoledronic acid Teva Pharma is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada ravimi Zoledronic acid Teva Pharma võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Pharma on 16 August 2012.
Estonian: Euroopa Komisjon andis ravimi Zoledronic acid Teva Pharma müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16. augustil 2012.
English: No additional studies were needed as Zoledronic acid Teva Pharma is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
Estonian: Lisauuringuid ei olnud vaja, sest Zoledronic acid Teva Pharma on infusioonina manustatav geneeriline ravim, mis sisaldab sama toimeainet kui võrdlusravim Aclasta.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva Pharma?
Estonian: Mis meetmed võetakse, et tagada ravimi Zoledronic acid Teva Pharma ohutu ja efektiivne kasutamine?
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva Pharma has been shown to be comparable to Aclasta.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Zoledronic acid Teva Pharma võrreldavus ravimiga Aclasta.
English: For more information about treatment with Zoledronic acid Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Zoledronic acid Teva Pharma toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Teva Pharma.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This means that Zoledronic acid Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aclasta.
Estonian: See tähendab, et Zoledronic acid Teva Pharma on sarnane võrdlusravimiga Aclasta, millel juba on Euroopa Liidus müügiluba.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Pharma, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi Zoledronic acid Teva Pharma omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Zoledronic acid Teva Pharma is given as an infusion lasting at least 15 minutes.
Estonian: Ravimit Zoledronic acid Teva Pharma manustatakse vähemalt 15 minutit kestva infusioonina.
English: Because Zoledronic acid Teva Pharma is a generic, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Zoledronic acid Teva Pharma on geneeriline ravim, peetakse ravimi kasulikkust ja riske samadeks mis võrdlusravimil.
English: Zoledronic acid Teva Pharma is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid (5 mg).
Estonian: Zoledronic acid Teva Pharma on infusioonilahus (veeni tilgutatav lahus), mis sisaldab toimeainena soledroonhapet (5 mg).
English: For Paget's disease, only one infusion of Zoledronic acid Teva Pharma is usually given, but additional infusions can be considered if the patient's disease comes back.
Estonian: Pageti luuhaigusega patsientidele tehakse ainult üks Zoledronic acid Teva Pharma infusioon, kuid haiguse taastudes võib infusioone korrata.
English: In the treatment of Paget's disease of the bone, Zoledronic acid Teva Pharma must only be used by a doctor who has experience in the treatment of the disease.
Estonian: Pageti luuhaiguse raviks tohib ravimit Zoledronic acid Teva Pharma manustada vaid selle haiguse ravis kogenud arst.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Pharma.
Estonian: See on ravimi Zoledronic acid Teva Pharma Euroopa avaliku hindamisaruande kokkuvõte.
English: Patients who have broken their hip should not receive Zoledronic acid Teva Pharma any earlier than two weeks after the operation to repair the fracture.
Estonian: Puusamurruga patsiendid tohivad ravimit Zoledronic acid Teva Pharma kasutada alles kaks nädalat pärast puusamurru parandamise operatsiooni.
English: The Committee recommended that Zoledronic acid Teva Pharma be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi Zoledronic acid Teva Pharma müügiloa.
English: Other information about Zoledronic acid Teva Pharma
Estonian: Muu teave ravimi Zoledronic acid Teva Pharma kohta
English: Zoledronic acid Teva Pharma is also used to treat Paget's disease of the bone in adults.
Estonian: Ravimit Zoledronic acid Teva Pharma kasutatakse ka Pageti luutõve raviks täiskasvanutel.
English: Zoledronic acid Teva Pharma is a ‘generic medicine'.
Estonian: Zoledronic acid Teva Pharma on geneeriline ravim.
English: Zoledronic acid Teva Pharma zoledronic acid
Estonian: Zoledronic acid Teva Pharma soledroonhape
English: Zoledronic acid Teva Pharma is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Estonian: Ravimit Zoledronic acid Teva Pharma kasutatakse osteoporoosi (luu-urbnemuse) raviks meestel ja menopausijärgses eas naistel.
English: What is Zoledronic acid Teva Pharma?
Estonian: Mis on Zoledronic acid Teva Pharma?
English: How does Zoledronic acid Teva Pharma work?
Estonian: Kuidas Zoledronic acid Teva Pharma toimib?
English: Why has Zoledronic acid Teva Pharma been approved?
Estonian: Miks Zoledronic acid Teva Pharma heaks kiideti?
English: The active substance in Zoledronic acid Teva Pharma, zoledronic acid, is a bisphosphonate.
Estonian: Ravimi Zoledronic acid Teva Pharma toimeaine soledroonhape on bisfosfonaat.
English: Therefore, the CHMP's view was that, as for Aclasta, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Aclasta korral, ületab ravimi Zoledronic acid Teva Pharma kasulikkus sellega kaasnevad riskid.
English: How has Zoledronic acid Teva Pharma been studied?
Estonian: Kuidas ravimit Zoledronic acid Teva Pharma uuriti?
English: Zoledronic acid Teva Pharma should not be used in patients with severe kidney problems.
Estonian: Raske neeruhaigusega patsientidel ei tohi ravimit Zoledronic acid Teva Pharma kasutada.
English: How is Zoledronic acid Teva Pharma used?
Estonian: Kuidas ravimit Zoledronic acid Teva Pharma kasutatakse?
English: What is Zoledronic acid Teva Pharma used for?
Estonian: Milleks ravimit Zoledronic acid Teva Pharma kasutatakse?
English: This is to be expected and you should not be concerned
Estonian: See on ootuspärane ja te ei pea selle pärast muretsema
English: Some may be serious and need medical attention.
Estonian: Mõned võivad olla tõsised ja vajada arstiabi.
English: However, this difference is not considered to be clinically relevant.
Estonian: Seda erinevust ei peetud aga kliiniliselt oluliseks.
English: Active control (ADA)
Estonian: Aktiivne kontroll (ADA)
English: Your doctor will tell you if this applies to you.
Estonian: Teie arst annab teile teada, kui see kohaldub teile.
English: Date of first authorisation: 22 March 2017
Estonian: Müügiloa esmase väljastamise kuupäev: 22. märts 2017
English: Efficacy may be decreased
Estonian: Võib vähendada efektiivsust
English: Treatment should be symptomatic and supportive.
Estonian: Ravi peab olema sümptomaatiline ja toetav.
English: Antimalarials were allowed.
Estonian: Malaariaravimid olid lubatud.
English: Women were estimated to have 7% lower AUC compared to men.
Estonian: Naistel oli hinnanguliselt 7% madalam AUC kui meestel.
English: Keep this Patient Alert Card with you.
Estonian: Kandke seda patsiendi teabekaarti endaga kaasas.
English: • If your treatment is interrupted, your doctor may decide to restart your treatment.
Estonian: • Kui teie ravi katkestatakse, võib teie arst otsustada teie ravi uuesti alustada.
English: Talk to your doctor if you smoke.
Estonian: Rääkige oma arstiga kui te suitsetate.
English: • Japanese or Korean patients.
Estonian: • Jaapani või Korea päritolu patsiendid;
English: Try to take your tablet at the same time every day (one tablet in the morning and one tablet in the evening).
Estonian: Püüdke võtta oma tablett iga päev samal ajal (üks tablett hommikul ja üks tablett õhtul).
English: These responses were similar to those observed in healthy volunteers aged 50 years and older.
Estonian: Need vastused sarnanesid vastustega, mida saadi tervetelt vabatahtlikelt vanuses 50 aastat ja üle selle.
English: A risk to the breast-fed child cannot be excluded.
Estonian: Riski imikutele ei saa välistada.
English: Some patients have presented with disseminated rather than localised disease.
Estonian: Mõnel patsiendil avaldus haigus dissemineerunud, mitte lokaliseerunud kujul.
English: There was no clear relationship between neutropenia and the occurrence of serious infections.
Estonian: Puudus selge suhe neutropeenia ja raskete infektsioonide esinemise vahel.
English: Maximum effects were generally observed within 6 weeks.
Estonian: Maksimaalne toime avaldus reeglina 6 nädala jooksul.
English: Take your next tablet at the usual time and continue as before.
Estonian: Võtke järgmine tablett tavalisel ajal ja jätkake samal viisil.
English: The median PsA disease duration was 3.8 years.
Estonian: PsA haiguse mediaankestus oli 3,8 aastat.
English: The efficacy results for important endpoints assessed are shown in Table 12.
Estonian: Hinnatud oluliste tulemusnäitajate efektiivsuse näitajad on esitatud tabelis 12.
English: Formal studies of the potential effect on human fertility have not been conducted.
Estonian: Formaalseid uuringuid võimaliku toime kohta inimese viljakusele ei ole läbi viidud.
English: The median PsA disease duration was 7.5 years.
Estonian: PsA haiguse mediaankestus oli 7,5 aastat.
English: Signs of allergic reactions (unknown) include
Estonian: Allergiliste reaktsioonide (teadmata) tunnused on
English: Once daily Do not swallow the desiccant.
Estonian: Üks kord ööpäevas Desikanti mitte alla neelata.
English: Tell your doctor immediately if you feel unwell.
Estonian: Teavitage oma arsti viivitamatult, kui te tunnete end halvasti.
English: He / she will also evaluate whether your body weight, age, or problems being mobile will affect your risk to develop blood clots.
Estonian: Ta hindab ka seda, kas teie kehakaal, vanus või liikumisprobleemid mõjutavad teie verehüüvete tekkimise riski.
English: OPAL BEYOND had a duration of 6 months.
Estonian: OPAL BEYOND kestis 6 kuud.
English: BID=twice daily.
Estonian: BID = kaks korda ööpäevas.
English: Pharmacotherapeutic groups: Immunosuppressants, Selective Immunosuppressants; ATC code: L04AA29
Estonian: Farmakoterapeutilised rühmad: immunosupressandid, selektiivsed immunosupressandid, ATC-kood: L04AA29
English: You should tell your doctor if you are using medicines (taken by mouth) that contain any of the following active substances:
Estonian: Öelge kindlasti oma arstile, kui kasutate (suukaudseid) ravimeid, mis sisaldavad järgmisi toimeaineid:
English: Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL
Estonian: Madalam kui või kuni 2 g/dl ning kõrgem kui või võrdne 9,0 g/dl
English: Greater than 2 g/dL decrease or less than 8.0 g/dL (confirmed by repeat testing)
Estonian: Kõrgem kui 2 g/dl või madalam kui 8,0 g/dl (kinnitatud kordusanalüüsidega)
English: The treatment interruption period in clinical studies extended up to 1 year.
Estonian: Kliinilistes uuringutes kestis ravi katkestamise periood kuni üks aasta.
English: Combination with other therapies
Estonian: Kombinatsioon teiste raviviisidega
English: Maintenance (OCTAVE Sustain)
Estonian: Säilitusravi (OCTAVE Sustain)
English: macrogol, and triacetin (E1518).
Estonian: makrogool ja triatsetiin (E1518).
English: If lab value confirmed by repeat testing within 7 days, dosing should be discontinued.
Estonian: Kui laboratoorne väärtus on kinnitatud 7 päeva jooksul toimunud kordusanalüüsiga, tuleb manustamine katkestada.
English: Your doctor may also perform other tests, for example to check your blood cholesterol levels or monitor the health of your liver.
Estonian: Teie arst võib teha ka muid analüüse, näiteks kontrollida teie vere kolesteroolitaset või jälgida teie maksa seisundit.
English: Elderly patients 80 years of age were estimated to have less than 5% higher AUC relative to the mean age of 55 years.
Estonian: Eakatel 80-aastastel patsientidel oli hinnanguliselt alla 5% kõrgem AUC kui keskmisel 55-aasta vanusel.
English: ALC greater than or equal to 750
Estonian: ALC on suurem kui või võrdne 750-ga
English: • Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4).
Estonian: • Aktiivne tuberkuloos (TB), rasked infektsioonid, nt sepsis, või oportunistlikud infektsioonid (vt lõik 4.4).
English: This treatment difference was consistent between the 2 subgroups (Table 16).
Estonian: Ravi erinevus langes kokku mõlemas alamrühmas (tabel 16).
English: There are no adequate and well-controlled studies on the use of tofacitinib in pregnant women.
Estonian: Puuduvad piisavad ja head kontrolliga uuringud tofatsitiniibi kasutamise kohta rasedatel.
English: This patient subsequently made a robust, though delayed, humoral and cellular response to the vaccine (see section 4.4).
Estonian: Sellel patsiendil esines hiljem jõuline, ehkki hiline humoraalne ja rakuline vastus vaktsiinile (vt lõik 4.4).
English: Health-related quality of life was assessed by the Short Form Health Survey (SF-36).
Estonian: Tervisega seotud elukvaliteeti hinnati lühikese terviseküsimustiku vormi alusel (Short Form Health Survey, SF-36).
English: In addition to this leaflet, your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given XELJANZ and during treatment with XELJANZ.
Estonian: Lisaks sellele infolehele annab arst teile ka patsiendi teabekaardi, mis sisaldab tähtsat ohutusalat informatsiooni, millest peate teadlik olema enne XELJANZi võtmist ja XELJANZ-ravi ajal.
English: 3 Parallel arms:
Estonian: 3 paralleelrühma:
English: SD = Standard Deviation b
Estonian: SD = standardhälve b
English: • Pregnancy and lactation (see section 4.6).
Estonian: • Rasedus ja imetamine (vt lõik 4.6).
English: Treatment groups (randomisation ratio)
Estonian: Ravirühmad (randomiseerimise suhe)
English: Nominal p≤0.05;
Estonian: Nominaalne p ≤ 0,05;
English: The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, or disease status.
Estonian: Ravi toime oli patsientidel sarnane, olenemata reumatoidfaktori staatusest, vanusest, soost, rassist või haigusseisundist.
English: Tofacitinib should not be initiated in patients with active infections, including localised infections.
Estonian: Ravi tofatsitiniibiga ei tohi alustada patsientidel, kellel on aktiivsed infektsioonid, sh lokaliseerunud infektsioonid.
English: XELJANZ must not be used during pregnancy.
Estonian: XELJANZi ei tohi kasutada raseduse ajal.
English: Physical function response and health-related outcomes
Estonian: Füüsilise funktsiooni vastus ja tervisega seotud tulemusnäitajad
English: These changes generally resolved within 2-6 weeks after discontinuation of treatment.
Estonian: Need muutused kadusid reeglina 2...6 nädalat pärast ravi algust.
English: Tofacitinib distributes equally between red blood cells and plasma.
Estonian: Tofatsitiniib jaotub ühtlaselt punaste vereliblede ja plasma vahel.
English: • unexplained changes in bowel habits
Estonian: • seletamatud muutused sooletühjendamisharjumustes
English: Vaccination with live vaccines should occur at least 2 weeks but preferably 4 weeks prior to initiation of tofacitinib or in accordance with current vaccination guidelines regarding immunomodulatory medicinal products.
Estonian: Elusvaktsiinidega vaktsineerimine peab toimuma vähemalt 2 nädalat, aga eelistatavalt 4 nädalat enne tofatsitiniibravi alustamist või kooskõlas kehtivate, immunomoduleerivate ravimitega seotud immuniseerimisjuhendiga.
English: The most commonly reported infections were upper respiratory tract infections and nasopharyngitis (3.7% and 3.2%, respectively).
Estonian: Kõige sagedamini teatatud infektsioonideks olid ülemiste hingamisteede infektsioonid ja nasofarüngiit (vastavalt 3,7% ja 3,2%).
English: Other medicines and XELJANZ
Estonian: Muud ravimid ja XELJANZ
English: For patients with Baseline BSA ≥ 3% and PASI > 0.
Estonian: Patsientidel, kelle ravieelne BSA oli ≥ 3% ja PASI > 0.
English: You may also be at higher risk of certain lung problems.
Estonian: Teil võib olla ka suurem teatud kopsuprobleemide oht.
English: Table 14 provides additional information regarding pertinent study design and population characteristics.
Estonian: Tabelis 14 on täiendav teave uuringu asjakohase ülesehituse ja populatsiooni omaduste kohta.
English: Serious infections in the elderly
Estonian: Rasked infektsioonid eakatel
English: Possible serious side effects In rare cases, infection may be life-threatening.
Estonian: Võimalikud tõsised kõrvaltoimed Harvadel juhtudel võivad infektsioonid olla eluohtlikud.
English: The available data have also shown that there are no major differences in tofacitinib AUC between White, Black and Asian patients.
Estonian: Lisaks näitavad olemasolevad andmed, et tofatsitiniibi AUC ei erinenud eriti valgete, mustanahaliste ja asiaatidest patsientide puhul.
English: Additional monitoring tests
Estonian: Täiendavad jälgimisanalüüsid
English: Your doctor may reduce the dose if you have liver or kidney problems or if you are prescribed certain other medicines.
Estonian: Teie arst võib vähendada annust, kui teil on maksa- või neeruprobleemid või kui teile on välja kirjutatud teatud muud ravimid.
English: Changes in circulating T-lymphocyte counts and T-lymphocyte subsets (CD3+, CD4+ and CD8+) were small and inconsistent.
Estonian: Muudatused tsirkuleerivate T-lümfotsüütide arvus ning T-lümfotsüütide alaklassides (CD3+, CD4+ ja CD8+) olid väikesed ja ebaolulised.
English: Asian patients
Estonian: Asiaatidest patsiendid
English: Table 7 provides information regarding the pertinent study design and population characteristics.
Estonian: Tabelis 7 on teave uuringu asjakohase ülesehituse ja populatsiooni omaduste kohta.
English: Each pack contains 56, 112, or 182 tablets and each bottle contains 60 or 180 tablets.
Estonian: Iga pakend sisaldab 56, 112 või 182 tabletti ja iga pudel sisaldab 60 või 180 tabletti.
English: • Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within 16 weeks.
Estonian: • Teie arst võib otsustada lõpetada XELJANZ-ravi, kui XELJANZ ei avalda teile toimet 16 nädala jooksul.
English: N=number of patients in the analysis set.
Estonian: N = analüüsitud patsientide arv.
English: • antibiotics such as rifampicin, used to treat bacterial infections
Estonian: • antibiootikumid, nt rifampitsiin, millega ravitakse bakteriaalseid infektsioone
English: Laboratory parameters
Estonian: Laboratoorsed parameetrid
English: Time to treatment failure in maintenance study OCTAVE sustain (Kaplan-Meier Curves)
Estonian: Aeg ravi ebaõnnestumiseni säilitusravi uuringus OCTAVE Sustain (Kaplani-Meieri kõverad)
English: Increases were observed at this time point and remained stable thereafter.
Estonian: Sel ajahetkel tuvastati tõus ning tase jäi seejärel stabiilseks.
English: Tell your doctor right away if you become pregnant while taking XELJANZ.
Estonian: Öelge oma arstile kohe, kui te XELJANZi võtmise ajal rasestute.
English: After intravenous administration, the volume of distribution is 87 L. Approximately 40% of circulating tofacitinib is bound to plasma proteins.
Estonian: Pärast intravenoosset manustamist on jaotusruumala 87 l. Ligikaudu 40% tsirkuleerivast tofatsitiniibist on seotud plasmavalkudega.
English: Time to onset was rapid (as early as week 2 in studies ORAL Solo, ORAL Sync, and ORAL Step) and the magnitude of response continued to improve with duration of treatment.
Estonian: Aeg avaldumiseni oli kiire (uuringutes ORAL Solo, ORAL Sync ja ORAL Step juba 2. nädalal) ning vastuse ulatus ravi vältel tugevnes.
English: Changes in mean HAQ-DI and DAS28-4(ESR) were maintained in both tofacitinib treatment groups through to the end of the studies.
Estonian: Keskmise HAQ-DI muudatused ja DAS28-4(ESR) muudatused säilisid mõlemas tofatsitiniibi ravirühmas kuni uuringute lõpuni.
English: If you have active psoriatic arthritis you will be first given another medicine to treat your psoriatic arthritis.
Estonian: Kui teil on aktiivne psoriaatiline artriit, antakse teile kõigepealt mõnda teist ravimit psoriaatilise artriidi raviks.
English: This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition.
Estonian: Selle ravimi kirjutab teile välja ja jälgib selle kasutamist erialaarst, kes teab, kuidas teie haigusseisundit ravida.
English: (see section 4.2).
Estonian: 3 kohta (vt lõik 4.2);
English: Nominal p<0.001;
Estonian: nominaalne p < 0,001;
English: Before you start XELJANZ, you should be up to date with all recommended vaccinations.
Estonian: Enne XELJANZi võtmise alustamist peate uuendama kõiki soovituslikke vaktsineerimisi.
English: In addition, safety and efficacy of tofacitinib were assessed in an open-label long-term extension study (OCTAVE Open).
Estonian: Lisaks hinnati tofatsitiniibi ohutust ja efektiivsust avatud pikaajalises jätku-uuringus (OCTAVE Open).
English: This condition is an inflammatory disease of the joints, often accompanied by psoriasis.
Estonian: Nimetatud seisund kujutab endast põletikulist liigesehaigust, millega kaasneb sageli psoriaas.
English: Pfizer Biofarmacêutica, Sociedade Unipessoal,
Estonian: Pfizer Biofarmacêutica, Sociedade Unipessoal, Lda.
English: Other side effects which have been observed with XELJANZ are listed below.
Estonian: Muud kõrvaltoimed, mida on täheldatud XELJANZi manustamisel, on loetletud allpool.
English: • who have been exposed to TB,
Estonian: • kes on kokku puutunud TB-ga,
English: • swelling of the lips, tongue or throat
Estonian: • huulte-, keele- või kõriturse
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2),
Estonian: - Teised koostisosad on mikrokristalliline tselluloos, laktoosmonohüdraat (vt lõik 2),
English: The carcinogenic potential of tofacitinib was assessed in 6-month rasH2 transgenic mouse carcinogenicity and 2-year rat carcinogenicity studies.
Estonian: Tofatsitiniibi kantserogeenset potentsiaali hinnati 6-kuulises rasH2 transgeenses hiire kantserogeensuse uuringus ja 2-aastases roti kantserogeensuse uuringus.
English: You can take XELJANZ with or without food.
Estonian: Te võite võtta XELJANZi nii koos toiduga või ilma.
English: The risk of opportunistic infections is higher in Asian geographic regions (see section 4.8).
Estonian: Aasia geograafilistes piirkondades on oportunistlike infektsioonide risk suurem (vt lõik 4.8).