FrancophonIA/ELRC3.0 huggingface dataset:
English: Each Cozaar 100 mg tablet contains 100 mg of losartan potassium.
Estonian: Iga Cozaar 100 mg tablett sisaldab 100 mg kaaliumlosartaani.
English: The CHMP was concerned that the benefit/risk ratio of this indication could not be adequately established.
Estonian: Inimravimite komitee otsustas, et fikseeritud annuste kombinatsiooni näidustusel hüpertensiooni esmaseks raviks puudub positiivne riski ja kasulikkuse suhe ning et see ei ole seetõttu vastuvõetav.
English: Each Cozaar 50 mg tablet contains 25.5 mg lactose monohydrate.
Estonian: Iga Cozaar 50 mg tablett sisaldab 25,5 mg laktoosmonohüdraati.
English: Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Estonian: Hüpotensioon ja elektrolüütide/vee tasakaalu häired Vähenenud intravaskulaarse vedelikumahuga ja/või naatriumi vähesusega patsientidel (nt suurtes annustes diureetilise ravi, piiratud soolatarbimise, kõhulahtisuse või oksendamise tõttu) tekib suurema tõenäosusega sümptomaatiline hüpotensioon, eriti esimese annuse manustamise ja annuse suurendamise järgselt.
English: Cozaar Startpakke
Estonian: COZAAR CARDIO START
English: Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135
Estonian: Luksemburg Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B1180 Brüssel, Belgia
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 25 mg
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Cozaar 25 mg karp
English: Each Cozaar 25 mg tablet contains 25 mg of losartan potassium.
Estonian: Iga Cozaar 25 mg tablett sisaldab 25 mg kaaliumlosartaani.
English: Marketing Authorisation Holder and Manufacturer
Estonian: Müügiloa hoidja ja tootja <Täidetakse riiklikul tasemel>
English: • dizziness,
Estonian: • sügelus,
English: The Cozaar 12.5 mg tablets also may contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
Estonian: Cozaar 12,5 mg tabletid võivad samuti sisaldada karnaubavaha (E903), titaandioksiidi (E171), indigokarmiini alumiiniumlakki (E132).
English: Each Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.
Estonian: Iga Cozaar 12,5 mg tablett sisaldab 12,5 mg kaaliumlosartaani.
English: Skanstes street 13, LV-1013, Riga
Estonian: SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV1013, Riia, Läti
English: Cardiac disorders: rare: syncope, artrial fibrillation, cerebrovascular accident Vascular disorders: uncommon: hypotension, including orthostatic hypotension Respiratory, thoracic and mediastinal disorders: uncommon: dyspnoea
Estonian: Aeg-ajalt: hüpotensioon, sealhulgas ortostaatiline hüpotensioon Respiratoorsed, rindkere ja mediastiinumi häired
English: Cozaar film-coated tablets losartan potassium
Estonian: Cozaar õhukese polümeerikattega tabletid losartaankaalium
English: • cough,
Estonian: • pearinglus,
English: • severe chest pain (angina pectoris),
Estonian: • tugev valu rinnus (stenokardia),
English: Each Cozaar 12,5 mg tablet contains 25.5 mg lactose monohydrate.
Estonian: Iga Cozaar 12,5 mg tablett sisaldab 25,5 mg laktoosmonohüdraati.
English: Each Cozaar 25 mg Tablet contains 25 mg of losartan (as potassium salt).
Estonian: Iga Cozaar 25 mg tablett sisaldab 25 mg losartaani (kaaliumisoolana).
English: Renal Function Impairment
Estonian: Neerufunktsiooni häired
English: Cozaar is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.
Estonian: Cozaar tarnitakse poolitusjooneta õhukese polümeerikattega tablettidena, mis sisaldavad 100 mg losartaankaaliumi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg losartan potassium.
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 12,5 mg losartaankaaliumi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 12.5 mg HDPE bottle
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Cozaar 12,5 mg HDPE pudeli karp
English: Cozaar is supplied as unscored film-coated tablets containing 25 mg of losartan potassium.
Estonian: Cozaar tarnitakse poolitusjooneta õhukese polümeerikattega tablettidena, mis sisaldavad 25 mg losartaankaaliumi.
English: Hypotension and Electrolyte/Fluid Imbalance
Estonian: Vere ja lümfisüsteemi häired
English: Cosaar 100 mg - Filmtabletten 100 mg
Estonian: Cosaar 100 mg - Filmtabletten
English: Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate.
Estonian: Iga Cozaar 25 mg tablett sisaldab 12,75 mg laktoosmonohüdraati.
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets.
Estonian: RAVIMVORM JA PAKENDI SUURUS 100 õhukese polümeerikattega tabletti.
English: PHARMACEUTICAL FORM AND CONTENTS 7 film-coated tablets
Estonian: RAVIMVORM JA PAKENDI SUURUS 7 õhukese polümeerikattega tabletti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 100 mg blister
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Cozaar 100 mg blistri karp
English: Other antihypertensive agents (diuretics, calcium antagonists, alpha- and beta-receptor blockers and also centrally acting antihypertensives) were permitted as supplementary treatment depending on the requirement in both groups.
Estonian: Mõlemas grupis võis vastavalt vajadusele lisada teisi antihüpertensiivseid ravimeid (diureetikumid, kaltsiumkanali blokaatorid, alfaja beetablokaatorid ning ka tsentraalselt toimivad ravimid).
English: Cozaar is supplied as scored film-coated tablets containing 50 mg of losartan potassium.
Estonian: Cozaar tarnitakse poolitusjoonega õhukese polümeerikattega tablettidena, mis sisaldavad 50 mg losartaankaaliumi.
English: Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential.
Estonian: Üldfarmakoloogilistes, genotoksilisuse ja kartsinogeense potentsiaali konventsionaalsetes uuringutes ei näidanud prekliinilised ohutusandmed mingit erilist ohtu inimestele.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium.
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 100 mg losartaankaaliumi.
English: NAME OF THE MEDICINAL PRODUCT Cozaar 12.5 mg film-coated tablets Cozaar 50 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Cozaar 12,5 mg õhukese polümeerikattega tabletid Cozaar 50 mg õhukese polümeerikattega tabletid
English: Each Cozaar 50 mg tablet contains 50 mg of losartan potassium.
Estonian: Iga Cozaar 50 mg tablett sisaldab 50 mg kaaliumlosartaani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 100 mg HDPE Bottle
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Cozaar 100 mg HDPE pudeli karp
English: Each Cozaar 50 mg Tablet contains 50 mg of losartan (as potassium salt).
Estonian: Iga Cozaar 50 mg tablett sisaldab 50 mg losartaani (kaaliumisoolana).
English: • muscle and joint pain,
Estonian: • lihas- ja liigesevalud,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg blister
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Cozaar 12,5 mg blistri karp
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg losartan potassium.
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 25 mg losartaankaaliumi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 50 mg blister
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Cozaar 50 mg blistri karp
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 50 mg HDPE bottle
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Cozaar 50 mg HDPE pudeli karp
English: • diarrhoea,
Estonian: • kõhulahtisus,
English: Uncommon: asthenia, fatigue, oedema
Estonian: Aeg-ajalt: urtikaaria, sügelus, lööve
English: Each Cozaar 100 mg Tablet contains 91 100 mg of losartan (as potassium salt).
Estonian: Iga Cozaar 100 mg tablett sisaldab 100 mg losartaani (kaaliumisoolana).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg losartan potassium.
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 50 mg losartaankaaliumi.
English: What Cozaar looks like and contents of the pack Cozaar is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.
Estonian: Cozaar tarnitakse poolitusjooneta õhukese polümeerikattega tablettidena, mis sisaldavad 12,5 mg losartaankaaliumi.
English: Immune system disorders: rare: hypersensitivity: anaphylactic reactions, angiooedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue; in some of these patients angiooedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors; vasculitis, including Henoch-Schonlein purpura.
Estonian: Harv: ülitundlikkus: anafülaktilised reaktsioonid, angioödeem, sh kõri ja häälepaelte piirkonna turse koos hingamisteede obstruktsiooniga ja/või näo-, huulte-, neelu- ja/või keeleturse.
English: White, oval unscored film-coated tablets marked 951 on one side and plain on the other.. Cozaar 50 mg tablet
Estonian: Valged ovaalsed õhukese polümeerikattega tabletid, mille ühel küljel on märge 951 ja mille teine külg on tühi.
English: Belgium Merck Sharp & Dohme BVChaussée de Waterloo 1135
Estonian: Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B1180 Brüssel, Belgia
English: 751 Patients were treated with Losartan The objective of the study was to demonstrate a nephroprotective effect of Losartan potassium over and above the benefit of a blood lowering pressure.
Estonian: Uuringu eesmärk oli lisaks losartaankaaliumi vererõhku langetavale toimele demonstreerida ka selle nefroprotektiivset toimet.
English: Paediatric hypertension
Estonian: Sage: hüpotensioon
English: Each Cozaar 50 mg film-coated mg tablet contains 50 mg losartan potassium.
Estonian: Cozaar 50 mg õhukese polümeerikattega tablett sisaldab 50 mg losartaankaaliumi.
English: Finland Merck Sharp & Dohme B.V. Waarderweg 39
Estonian: Merck Sharp & Dohme B.V.
English: The Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Estonian: Cozaar 100 mg tabletid võivad samuti sisaldada karnaubavaha (E903), titaandioksiidi (E171).
English: COZAAR CARDIO START 21 x 12.5 mg + 14 x 50 mg Film-coated tablet Oral use
Estonian: Cozaar Startpakke 12,5 mg + 50 mg Õhukese polümeerikattega tabletidsuukaudne
English: NAME OF THE MEDICINAL PRODUCT Cozaar 25 mg film-coated tablets Losartan
Estonian: RAVIMPREPARAADI NIMETUS Cozaar 25 mg õhukese polümeerikattega tabletid Losartaan
English: • somnolence,
Estonian: • kõhukinnisus,
English: • nausea,
Estonian: • köha,
English: Renal and urinary disorders: not known: urinary tract infections
Estonian: Neerude ja kuseteede häired Teadmata: kuseteede infektsioonid
English: NAME OF THE MEDICINAL PRODUCT Cozaar 12.5 mg film-coated tablets Losartan
Estonian: RAVIMPREPARAADI NIMETUS Cozaar 12,5 mg õhukese polümeerikattega tabletid Losartaan
English: The Cozaar 25 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Estonian: Cozaar 25 mg tabletid võivad samuti sisaldada karnaubavaha (E903), titaandioksiidi (E171).
English: The Cozaar 50 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Estonian: Cozaar 50 mg tabletid võivad samuti sisaldada karnaubavaha (E903), titaandioksiidi (E171).
English: PHARMACEUTICAL FORM
Estonian: Ravimvorm
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Estonian: MANUSTAMISVIIS JA -TEE Suukaudne.
English: There is no therapeutic experience in patients with severe hepatic impairment.
Estonian: Raske maksakahjustuse korral ravikogemused puuduvad.
English: Nervous system disorders: common: dizziness
Estonian: Närvisüsteemi häired Sage: pearinglus
English: Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Estonian: Aeg-ajalt: kõhulahtisus, iiveldus, oksendamine
English: • fatigue,
Estonian: • unehäired,
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED <[Täidetakse riiklikul tasemel]>
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each Cozaar 12.5 mg film-coated mg tablet contains 12.5 mg losartan potassium.
Estonian: Cozaar 12,5 mg õhukese polümeerikattega tablett sisaldab 12,5 mg losartaankaaliumi.
English: Severe hepatic impairment
Estonian: Naha ja nahaaluskoe kahjustused
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
Estonian: Merck Sharp & Dohme Limited Hertford
English: (See section 4.5).
Estonian: (Vt lõik 4.5).
English: Open here
Estonian: Ava siit
English: How much and how often to take?
Estonian: Kui palju ravimit ja millal manustada?
English: Slowly release your thumb up.
Estonian: Tõstke pöial aeglaselt üles.
English: 6.6 The needle is now covered and is safe.
Estonian: 6.6 Nõel on nüüd kaetud ja ohutu.
English: Important Information
Estonian: Oluline teave
English: Tell your doctor as soon as possible, if you notice any of the following:
Estonian: Rääkige oma arstile niipea kui võimalik, kui märkate midagi järgnevast:
English: 1.4 You will also need following supplies that are not included in the kit:
Estonian: 1.4 Te vajate ka järgmisi tarvikuid, mis ei kuulu komplekti:
English: Note: With experience, you will find the angle (between 45° an 90°) that is most comfortable for you and the child.
Estonian: Kogemuste kasvades leiate nurga (vahemikus 45° kuni 90°), mis on teile ja teie lapsele kõige mugavam.
English: • You did not inject the full dose or
Estonian: • te ei süstinud kogu annust või
English: You will hear a loud click, which means the injection has started.
Estonian: Kuulete valju klõpsu, mis tähendab, et süstimine on alanud.
English: • Properly labeled to warn of hazardous waste inside the container.
Estonian: • õigesti märgistatud - teavitab konteineris olevatest ohtlikest jäätmetest.
English: If you do not have a sharps disposal container, you may use a household container that is:
Estonian: Kui teil ei ole teravate esemete konteinerit, siis võite kasutada mõnda majapidamises leiduvat konteinerit, mis on:
English: Tuberculosis (TB)
Estonian: Tuberkuloos (Tb)
English: Injecting cold medicine may be painful.
Estonian: Külma ravimi süstimine võib olla valus.
English: Other medicines and Kromeya
Estonian: Muud ravimid ja Kromeya
English: 1.2 You will also need (Figure A):
Estonian: 1.2 Teil läheb tarvis ka (joonis A):
English: Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
Estonian: Otsige kiiresti arstiabi, kui te märkate mis tahes järgnevat allergilise reaktsiooni või südamepuudulikkuse tunnust:
English: 61352 Bad Homburg v.d.Höhe Germany
Estonian: 61352 Bad Homburg v.d.Höhe Saksamaa
English: Significant response was first observed at week 2 and maintained through 24 weeks (Table
Estonian: Esmalt täheldati olulist vastust 2. nädalal ning see püsis läbi 24 nädala (tabel 13).
English: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Estonian: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Šveits
English: • Hold the syringe like a pencil.
Estonian: • Hoidke süstlit käes nagu pliiatsit.
English: The liquid should be clear and colorless.
Estonian: Vedelik peab olema selge ja värvitu.
English: Injecting cold medicine can be painful (Figure E).
Estonian: Külma ravimi süstimine võib olla valus (joonis E).
English: Clinical response (CR- 100)
Estonian: Kliiniline ravivastus (CR-100)
English: Travel/recurrent infection
Estonian: Reisimine/korduv infektsioon
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Estonian: Uuring peab hõlmama kolonoskoopiat ja biopsiaid vastavalt kohalikele juhenditele.
English: 7.1 Now that you have completed your injection, update your record with:
Estonian: 7.1 Nüüd kus olete süstimise lõpetanud, täiendage oma märkmeid, kirjutades üles:
English: It can now be thrown away in the sharps container.
Estonian: Selle saab nüüd visata ära teravate esemete konteinerisse.
English: Surgery or dental procedures
Estonian: Kirurgia või hambaraviprotseduurid
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomized design.
Estonian: Andmete tõlgendamist võib mõjutad uuringu metodoloogiline piiratus, sh väike valimi suurus ja mitterandomiseeritud ülesehitus.
English: Your child may first be given other medicines.
Estonian: Alguses võidakse teie lapsele anda teisi ravimeid.
English: c,d,e
Estonian: ASDASc,d,e
English: - This medicine has been prescribed for your child only.
Estonian: - Ravim on välja kirjutatud üksnes teie lapsele.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
Estonian: * lisainformatsioon on toodud lõikudes 4.3, 4.4 ja 4.8 ** sealhulgas avatud jätku-uuringud 1) sealhulgas spontaansed teated
English: • A sharps container (see section 7.2).
Estonian: • teravate esemete konteinerit (vt lõik 7.2).
English: • When the syringe plunger has moved to the bottom and has stopped moving, continue holding it for 5 seconds.
Estonian: • Kui süstli kolb on lõpuni alla liikunud ja enam ei liigu, hoidke pen-süstlit paigal veel 5 sekundit.
English: Table 17 Maintenance regimen
Estonian: Tabel 17 Säilitusskeem
English: Median time to failure (months)
Estonian: Mediaanaeg ebaõnnestumiseni (kuudes)
English: Therefore, the combination of adalimumab and anakinra is not recommended.
Estonian: Seetõttu ei soovitata adalimumabi ja anakinrat omavahel kombineerida.
English: Results from the overall UC-II study population are shown in Table 26.
Estonian: Uuringus UC-II osalenute üldtulemused on toodud tabelis 26.
English: Kromeya can also be given alone.
Estonian: Kromeya't võib kasutada ka üksinda.
English: Check components to make sure that the packaging and the content are not damaged.
Estonian: Kontrollige kõiki komplekti osasid, et veenduda, kas pakendid ja nende sisu on rikkumata.
English: • severe allergic reaction with shock;
Estonian: • raske allergiline reaktsioon koos šokiga;
English: Week 8 and 52
Estonian: 8. ja 52 nädal
English: PGA-F clear/minimal and ≥2-grade improvement (%)
Estonian: PGA-F puhas/minimaalne ja paranemine ≥ 2 raskusastme võrra (%)
English: Your doctor may prescribe another strength of Kromeya if your child needs a different dose.
Estonian: Teie arst võib teile määrata teistsuguse tugevusega Kromeya, kui teie laps vajab teistsugust annust.
English: 1.1 Remove the Kromeya Vial Kit from the refrigerator.
Estonian: 1.1 Võtke Kromeya viaali komplekt külmkapist välja.
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
Estonian: TNF-antagonistid, nagu adalimumab, mõjutavad immuunsüsteemi ja nende kasutamine võib mõjutada keha kaitsevõimet infektsioonide ja vähi suhtes.
English: confidence interval)
Estonian: usaldusvahemik)
English: Clinical studies in patients suffering hidradenitis suppurativa in this section are merely included for public health reasons.
Estonian: Mädase hidradeniidiga patsientide kliiniliste uuringute andmed on selles lõigus lisatid peamiselt rahvatervise põhjustel.
English: Warning: Do not use the vial if:
Estonian: Ärge kasutage viaali, kui:
English: Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
Estonian: Ravi jätkamine kauem kui 12 nädalat ei andnud tulemuseks märkimisväärselt rohkem ravivastuseid (vt lõik 4.2).
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Estonian: Kombineerimine haigust modifitseerivate antireumaatiliste ravimitega peale metotreksaadi, vt lõigud 4.4 ja 5.1.
English: Without MTX
Estonian: Ilma MTX'ta
English: N/A
Estonian: N/A N/A
English: • Talk to your healthcare professional if you have any questions or concerns.
Estonian: • Rääkige oma tervishoiutöötajale, kui teil on mis tahes küsimusi või probleeme.
English: NA 9.5% 41.5%
Estonian: NA NA 9,5% 41,5%
English: In study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Estonian: Uuringus UV II täheldati statistiliselt olulisi erinevusi ainult nägemisteravuse puhul, kuid teised komponendid olid arvuliselt adalimumabi kasuks.
English: Failure N (%)
Estonian: N Ebaõnnestumine N (%)
English: Monoclonal antibodies are proteins that attach to a specific target in the body.
Estonian: Monoklonaalsed antikehad on proteiinid ehk valgud, mis seonduvad spetsiifilise sihtmärgiga kehas.
English: Then release the pinched skin.
Estonian: Seejärel vabastage volti tõmmatud nahk.
English: - if you have moderate or severe heart failure.
Estonian: - kui teil on mõõdukas või raske südamepuudulikkus.
English: Most ALT elevations occurred with concomitant methotrexate use.
Estonian: ALAT aktiivsuse tõus esines enamasti siis, kui samaaegselt kasutati metotreksaati.
English: In CD study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Estonian: CD uuringus III esines 4. nädalal 58% (499/854) patsientidest kliiniline vastus ja neid hinnati esmase analüüsiga.
English: The potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab should be carefully considered.
Estonian: Asatiopriini või 6-merkaptopuriini ja adalimumabi samaaegsel kasutamisel esinevat võimalikku riski tuleb hoolikalt kaaluda.
English: Detailed instructions on how to inject Kromeya are provided in section 7 ‘Instructions for use'.
Estonian: Täpne juhend Kromeya süstimiseks on lõigus 7 „Kasutusjuhend“.
English: Radiographic response
Estonian: Radiograafiline vastus
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Estonian: Tärn (*) on organsüsteemi klassi tulbas, kui lisainformatsioon on toodud lõikudes 4.3, 4.4 ja
English: Not all presentations may be marketed.
Estonian: Kõik ravimvormid ei pruugi olla müügil.
English: What Kromeya looks like and contents of the pack
Estonian: Kuidas Kromeya välja näeb ja pakendi sisu
English: Again slowly pull the plunger out to the prescribed dose and stop.
Estonian: Püüdke uuesti aeglaselt tõmmata kolb välja kuni määratud annuseni ja peatuge.
English: In rare cases, these infections may be lifethreatening.
Estonian: Need infektsioonid võivad harvadel juhtudel olla eluohtlikud.
English: Open your sharps disposal container so it is ready to use.
Estonian: Avage teravate esemete konteiner, nii et see on kasutamiseks valmis.
English: Impaired lung function may increase the risk for developing infections.
Estonian: Kopsufunktsiooni kahjustus võib suurendada infektsioonide arenemise riski.
English: One hundred patients (n=100) from the Paediatric CD study continued in an open-label long-term extension study.
Estonian: Sada patsienti (n=100) laste CD uuringust jätkas osalemist avatud pikaajalises jätku-uuringus.
English: According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Estonian: Rasedusuuringu alusel ei esinenud suuremat sünnidefektide riski, kui ema sai raseduse ajal ravi adalimumabiga, võrreldes rasedustega, kui sama haigusega emad ei saanud ravi adalimumabiga.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Estonian: Samaaegne aminosalitsülaatide, kortikosteroidide, ja/või immunomoduleerivate ainete stabiilsete annuste kasutamine oli lubatud ja 80% patsientidest jätkas vähemalt ühe sellise ravimi võtmist.
English: ASASa,b 20 ASAS
Estonian: ASASa,b 20
English: The recommended doses for Kromeya in each of the approved uses are shown in the following table.
Estonian: Kromeya soovitatavad annused iga kinnitatud näidustuse puhul on esitatud alljärgnevas tabelis.