FrancophonIA/ELRC3.0 huggingface dataset:
English: • Not known (frequency cannot be estimated from the available data): Merkel cell carcinoma (a type of skin cancer); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash).
Norwegian Bokmål: • Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli): karċinoma taċ-ċelluli Merkel (tip ta' kanċer tal-ġilda); attivazzjoni eċċessiva ta' ċelluli bojod tad-demm assoċjati ma' infjammazzjoni (sindrome ta' l-attivazzjoni tal-makrofagu) ; rikorrenza tal-epatite B (infezzjoni tal-fwied); aggravar ta' kundizzjoni msejħa dermatomijosite (infjammazzjoni u dgħjufija talmuskoli b'raxx tal-ġilda li jiġi magħha).
English: Concurrent treatment with sulfasalazine
Norwegian Bokmål: Il-kura fl-istess ħin ma' sulfasalazine
English: Instead, the safety and efficacy of LIFMIOR were assessed in four randomised, double-blind, placebo-controlled studies.
Norwegian Bokmål: Minflok, is-sigurtà u l-effikaċja ta' LIFMIOR kienu evalwati f'erba' studji randomised, double-blind u kkontrollati bil-plaċebo.
English: A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Norwegian Bokmål: Ma jistax jiġi eskluż riskju li jiżviluppaw tumuri malinni fi tfal u adolexxenti li jkunu kkurati b'antagonisti ta' TNF.
English: Step 3: Injecting the LIFMIOR solution
Norwegian Bokmål: Pass 3: Kif tinjetta s-soluzzjoni ta' LIFMIOR
English: 48 alcohol swabs
Norwegian Bokmål: 48 swab ta' l-alkoħol
English: b. One cotton ball or gauze
Norwegian Bokmål: B. FULJETT TA' TAGĦRIF
English: Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients.
Norwegian Bokmål: Il-profili talkonċentrazzjoni fis-serum kienu simili għal dawk il-pazjenti adulti li kellhom l-artrite rewmatojde.
English: TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs.
Norwegian Bokmål: TNF u lymphotoxin jeżistu l-aktar bħala homotrimers, bl-attività bijoloġika tagħhom li hi dipendenti fuq cross-linking ma' TNFRs fuq is-superfiċje taċ-ċelluli.
English: 50 mg BIW
Norwegian Bokmål: 50 mg darbtejn filġimgħa
English: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Norwegian Bokmål: Id-doża rakkomandata hi ta' 0.4 mg/kg (sa massimu ta' 25 mg għal kull doża), mogħti darbtejn f'ġimgħa bħala injezzjoni taħt il-ġilda b'intervall ta' 3-4 ijiem bejn id-dożi jew 0.8 mg/kg (sa massimu ta' 50 mg kull doża) mogħtija darba fil-ġimgħa.
English: This leaflet was last revised in
Norwegian Bokmål: DATA TA' META ĠIET RIVEDUTA L-KITBA
English: The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and plastic plunger.
Norwegian Bokmål: Is-siringa ġol-pinna hi magħmula minn ħġieġ ċar ta' tip 1 b'labra ta' azzar li ma jsaddadx ta' 27 gauge, għatu tal-labra magħmul mil-lastku, u planġer tal-plastik.
English: (frequency rare).
Norwegian Bokmål: Frekwenza Mhux
English: The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Norwegian Bokmål: Il-mekkaniżmu ta' l-azzjoni ta' etanercept hu maħsub li hu ta' impedizzjoni kompetittiva tat-TNF li jeħel mas-superfiċje taċ-ċelluli TNFR, u ma jippermettix ir-risponsi ċellulari medjati ta' TNF billi jġib it-TNF bijoloġikalment inattiv.
English: The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex).
Norwegian Bokmål: L-għatu tal-labra tal-pinna mimlija għal-lest fih lastku naturali xott (derivattiv tal-latex).
English: LIFMIOR 25 mg powder and solvent for solution for injection.
Norwegian Bokmål: LIFMIOR 25 mg trab u solvent għal soluzzjoni għall-injezzjoni.
English: 12b
Norwegian Bokmål: Introduzzjoni b.
English: Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Norwegian Bokmål: Kura ta' poliartrite (fattur rewmatojde pożittiv jew negattiv) u oligoartrite estiża fit-tfal u adolexxenti mill-età ta' sentejn li kellhom rispons mhux adegwat għal, jew li ntwera li ma jittollerawx, methotrexate.
English: Instructions for preparing and giving an injection of LIFMIOR
Norwegian Bokmål: Istruzzjonijiet għall-preparazzjoni u kif tagħti injezzjoni ta' LIFMIOR
English: CARTON TEXT - (25 mg Pre-filled Syringe) - EU/1/16/1165/005-007
Norwegian Bokmål: KITBA FUQ IL-KARTUNA - EU/1/16/1165/005-007 (Siringa mimlija għal-lest 25 mg)
English: In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving LIFMIOR during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of openlabel extension therapy.
Norwegian Bokmål: Fi studju fi tfal b'artrite idjopatika taż-żgħażagħ li għandhom minn 4 sa 17-il sena, 43 mid-69 (62%) tat-tfal li kienu fuq il-kura b'LIFMIOR kellhom infezzjoni matul it-3 xhur ta' l-istudju (l-ewwel parti open-label), u l-frekwenza u s-severità ta' l-infezzjoni kienet simili fi 58 pazjent li spiċċaw it-12il xahar ta' terapija open-label ta' estensjoni.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Norwegian Bokmål: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: DAS Baseline scoreb Week 52 scoreb
Norwegian Bokmål: 24 kunjett ta' trab
English: Significant improvement was also observed for the ASAS partial remission and BASDAI 50.
Norwegian Bokmål: Titjib sinifikanti kien osservat ukoll għar-remissjoni parzjali tal-ASAS u BASDAI 50.
English: Interstitial lung disease
Norwegian Bokmål: Mard interstizjali tal-pulmun
English: INSTRUCTIONS ON USE
Norwegian Bokmål: KORRETT INKORETT
English: In adults (aged 18 and over), LIFMIOR can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis - in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
Norwegian Bokmål: Fl-adulti (ta' 18-il sena jew aktar), LIFMIOR jista' jintuża għal artrite rewmatojde, artrite psorjatika minn moderata sa severa, spondiloartrite assjali severa li tinkludi ankylosing spondylitis, u psorjasi moderata jew severa - f'kull każ fejn ġeneralment kuri użati komunament ma jkunux ħadmu tajjeb biżżejjed jew m'humiex adattati għalik.
English: Method of administration LIFMIOR is administered by subcutaneous injection (see section 6.6).
Norwegian Bokmål: Kif jingħata LIFMIOR jingħata permezz ta' injezzjoni taħt il-ġilda (ara sezzjoni 6.6).
English: LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use.
Norwegian Bokmål: LIFMIOR 10 mg trab u solvent għal soluzzjoni għall-injezzjoni għall-użu pedjatriku.
English: Serious side effects
Norwegian Bokmål: Effetti sekondarji serji
English: Histiocytosis haematophagic (macrophage activation
Norwegian Bokmål: TWISSIJA(IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
English: • Uncommon (may affect up to 1 in 100 people):
Norwegian Bokmål: • Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10):
English: Each pre-filled syringe contains 1.0 ml of solution, providing 50 mg of etanercept.
Norwegian Bokmål: Kull siringa mimlija għal-lest fiha 1.0 ml ta' soluzzjoni, li tipprovdi 50 mg ta' etanercept.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 ml water for injections
Norwegian Bokmål: 1 ml ilma għall-injezzjonijiet
English: At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving LIFMIOR.
Norwegian Bokmål: Fil-ġimgħa 12, kien hemm titjib statistikament sinifikanti fil-punteġġ tal-SPARCC (Konsorzju talKanada għar-Riċerka dwar l-Ispondiloartrite) għall-ġog sakroiljaku (SIJ) kif imkejjel mill-MRI għal pazjenti li kienu qed jirċievu LIFMIOR.
English: Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Norwegian Bokmål: Etanercept jista' wkoll jimmodula r-risponsi bijoloġiċi kkontrollati b'molekuli addizzjonali downstream (eż.
English: In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with LIFMIOR or placebo for moderate to severe alcoholic hepatitis, LIFMIOR was not efficacious, and the mortality rate in patients treated with LIFMIOR was significantly higher after 6 months.
Norwegian Bokmål: Fi studju ta' fażi II, randomised, ikkontrollat bil-plaċebo, ta' 48 pazjent li kienu l-isptar, ikkurati b'LIFMIOR jew bil-plaċebo, għal epatite alkoħolika minn moderata sa severa, LIFMIOR ma kienx effikaċi, u r-rata ta' mortalità f'pazjenti kkurati b'LIFMIOR kienet ogħla b'mod sinifikanti wara 6 xhur.
English: Non-radiographic axial spondyloarthritis
Norwegian Bokmål: Spondiloartrite assjali mhux radjografika
English: Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis
Norwegian Bokmål: Dawn l-antikorpi kienu kollha non-newtralizzanti u huma ġeneralment temporanji.
English: Adult patients treated with LIFMIOR and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either LIFMIOR or anakinra alone (historical data).
Norwegian Bokmål: Kien osservat li pazjenti adulti kkurati b'LIFMIOR u b'anakinra kellhom rata ogħla ta' infezzjonijiet serji meta mqabbla ma' pazjenti kkurati jew b'LIFMIOR jew b'anakinra waħidhom (informazzjoni storika).
English: Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)*
Norwegian Bokmål: Reazzjoni fis-sit fejn tingħata linjezzjoni (inkluż ħruġ ta' demm, tbenġil, eritema, ħakk, uġigħ, nefħa)*
English: LIFMIOR 25 mg solution for injection in pre-filled syringe.
Norwegian Bokmål: LIFMIOR 25 mg trab għal soluzzjoni għall-injezzjoni.
English: Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
Norwegian Bokmål: Infezzjonijiet (li jinkludu rjiħat, sinusite, bronkite, infezzjonijiet ta' l-apparat urinarju u infezzjonijiet tal-ġilda); reazzjonijiet fis-sit ta' l-injezzjoni (li jinkludu ħruġ ta' demm, tbenġil,
English: LIFMIOR 25 mg solution for injection in pre-filled syringe LIFMIOR 50 mg solution for injection in pre-filled syringe
Norwegian Bokmål: LIFMIOR 25 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest LIFMIOR 50 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: • Remove the plastic cap from the LIFMIOR vial (see Diagram 1).
Norwegian Bokmål: Neħħi l-għatu tal-plastik mill-kunjett ta' LIFMIOR (ara Dijagramma 1).
English: However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously (see section 5.1).
Norwegian Bokmål: Madankollu, tagħrif limitat dwar issigurtà minn reġistru ta' pazjent jissuġġerixxi li l-profil tas-sigurtà fi tfal minn sentejn sa 3 snin huwa simili għal dak li jidher fl-adulti u tfal minn 4 snin 'il fuq, meta ddożati kull ġimgħa b'0.8 mg/kg taħt il-ġilda (ara sezzjoni 5.1).
English: This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with plaque psoriasis.
Norwegian Bokmål: Din is-sezzjoni fiha tagħrif meħud minn erba' studji randomised u kkontrollati f'adulti b'artrite rewmatojde, studju wieħed f'adulti b'artrite psorjatika, studju wieħed f'adulti b‘ankylosing spondylitis, studju wieħed f'adulti bi spondiloartrite assjali mhux radjografika, erba' studji f'adulti bi psorjasi tal-plakka, tliet studji ta' pazjenti b'artrite idjopatika taż-żgħażagħ, studju wieħed fuq pazjenti pedjatriċi bi psorjasi tal-plakka.
English: Patients were between 18 and 70 years of age and had active psoriatic arthritis (≥ 3 swollen joints and ≥ 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
Norwegian Bokmål: It-tliet siti rakkomandati għall-injezzjoni ta' LIFMIOR jinkludu: (1) in-naħa ta' quddiem tannaħa tan-nofs tal-koxox; (2) iż-żaqq, ħlief għaż-żona ta' 5 ċm madwar iż-żokra; u (3) in-naħa ta' barra tan-naħa ta' fuq tad-dirgħajn (ara Dijagramma 17).
English: Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution.
Norwegian Bokmål: L-istabbilità kimika jew fiżika waqt l-użu ntweriet għal 6 sigħat f'temperaturi ta' massimu ta' 25C wara r-rikostituzzjoni.
English: Compared to placebo, treatment with LIFMIOR resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
Norwegian Bokmål: Meta mqabbla mal-plaċebo, il-kura b'LIFMIOR irriżultat f'titjib sinifikanti f'ASAS 20, ASAS 50 u ASAS 70 sa minn ġimagħtejn wara li nbdiet it-terapija.
English: Month 12
Norwegian Bokmål: Xahar 12
English: LIFMIOR 50 mg solution for injection in pre-filled syringe.
Norwegian Bokmål: LIFMIOR 50 mg trab għal soluzzjoni għall-injezzjoni.
English: The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Norwegian Bokmål: L-effikaċja ta' LIFMIOR kienet evalwata f'205 pazjenti li kellhom artrite psorjatika fi studju randomised, double-blind u kkontrollat bil-plaċebo.
English: demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Norwegian Bokmål: Din it-taħlita ma wrietx żieda fil-benefiċċju kliniku; użu bħal dan mhuwiex rakkomandat (ara sezzjoni 4.4).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Norwegian Bokmål: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: 1.0 ml (50 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Norwegian Bokmål: 12 (3 x 4) ferdigfylte penner (multipakning)
English: Immediate Packaging
Norwegian Bokmål: 1 ferdigfylt penn
English: Pack size bottle (HDPE)
Norwegian Bokmål: Indre emballasje Pakningsstørrelse flaske (HDPE)
English: Strength Pharmaceutical Form
Norwegian Bokmål: Styrke
English: What X is and what it is used for
Norwegian Bokmål: Hva X er og hva det brukes mot
English: Other medicines and X
Norwegian Bokmål: Andre legemidler og X
English: The study was terminated early because of an increased risk of adverse outcomes.
Norwegian Bokmål: Studien ble avsluttet tidlig pga. økt risiko for uønskede hendelser.
English: This combination apparently increases the risk for adverse events and is therefore not recommended.
Norwegian Bokmål: Denne kombinasjonen gir tilsynelatende økt risiko for bivirkninger og anbefales derfor ikke.
English: “Your doctor may need to change your dose and/or to take other precautions:
Norwegian Bokmål: «Legen kan endre dosen din og/eller ta andre forholdsregler:
English: “Heart failure
Norwegian Bokmål: «Hjertesvikt
English: Section 5.1 - Pharmacodynamic properties
Norwegian Bokmål: 5.1 Farmakodynamiske egenskaper
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Norwegian Bokmål: 4.5 Interaksjon med andre legemidler og andre former for interaksjon
English: “Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Norwegian Bokmål: «Dobbel blokade av renin-angiotensin-aldosteronsystemet (RAAS)
English: Caution should be observed when initiating therapy in patients with heart failure.
Norwegian Bokmål: Forsiktighet bør utvises ved start av behandling hos pasienter med hjertesvikt.
English: These medicines are for the treatment of heart failure (see “Other medicines and X”).”
Norwegian Bokmål: Disse legemidlene brukes ved behandling av hjertesvikt (se «Andre legemidler og X»).»
English: Annex II Amendments to relevant sections of the summary of product characteristics and package leaflet
Norwegian Bokmål: Vedlegg II Endringer til relevante avsnitt i preparatomtale og pakningsvedlegg
English: (ACE-inhibitors and MRAs are medicines used to treat heart failure).”
Norwegian Bokmål: (ACE-hemmere og MRA er legemidler som brukes ved behandling av hjertesvikt).»
English: • “if you are taking any of the following medicines used to treat high blood pressure:
Norwegian Bokmål: • dersom du bruker noen av følgende legemidler mot høyt blodtrykk:
English: Do not <take> <use> X <:>
Norwegian Bokmål: Bruk ikke X<:>
English: Section 4.3 - Contraindication
Norwegian Bokmål: 4.3 Kontraindikasjoner
English: Valsartan may be administered with other heart failure therapies.
Norwegian Bokmål: “Valsartan kan administreres sammen med annen hjertesviktbehandling.
English: In addition, the existing heart failure indication should be revised as follows:
Norwegian Bokmål: I tillegg skal den eksisterende indikasjonen for hjertesvikt revideres på følgende måte:
English: Evaluation of patients with heart failure should always include assessment of renal function.”
Norwegian Bokmål: Utredning av pasienter med hjertesvikt bør alltid inkludere kontroll av nyrefunksjon.»
English: As valsartan is an angiotensin II receptor blocker, it cannot be excluded that the use of [Product name] may be associated with impairment of the renal function.
Norwegian Bokmål: Da valsartan er en angiotensin II-antagonist, kan det ikke utelukkes at bruk av [Legemidlets navn] kan være forbundet med nedsatt nyrefunksjon.
English: Talk to your doctor <or> <pharmacist> <or nurse> before <taking> <using> X
Norwegian Bokmål: Rådfør deg med lege <eller> <,> <apotek> <eller sykepleier> før du bruker X
English: “[Product name] can be administered with other heart failure treatment, including ACE-inhibitors, beta-blockers, diuretics and digitalis or a combination of these medicinal products.
Norwegian Bokmål: “[Legemidlets navn] kan administreres sammen med annen hjertesviktbehandling, inkludert ACEhemmere, betablokkere, diuretika og digitalis eller en kombinasjon av disse legemidlene.
English: - an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan,
Norwegian Bokmål: o en angiotensin II-reseptorhemmer (ARB) (også kalt -sartaner, f.eks. valsartan,
English: What you need to know before you <take> <use> X
Norwegian Bokmål: Hva du må vite før du bruker X
English: Section 4.2 - Posology and method of administration
Norwegian Bokmål: 4.2 Dosering og administrasjonsmåte
English: These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed.
Norwegian Bokmål: Disse studiene viste ingen signifikant gunstig effekt på renale og/eller kardiovaskulære hendelser og dødelighet, men det ble sett økt risiko for hyperkalemi, akutt nyreskade og/eller hypotensjon sammenlignet med monoterapi.
English: Use of [Product name] in patients with heart failure commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Norwegian Bokmål: Bruk av [Legemidlets navn] hos pasienter med hjertesvikt fører ofte til en viss reduksjon av blodtrykket, men seponering av behandlingen som følge av en vedvarende symptomatisk hypotensjon er vanligvis ikke nødvendig dersom angitte doseringsanbefalinger følges (se pkt.
English: • “if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren”
Norwegian Bokmål: • «dersom du har diabetes eller nedsatt nyrefunksjon, og du får behandling med et legemiddel mot høyt blodtrykk som inneholder aliskiren.»
English: For products containing the angiotensin-converting enzyme inhibitors (ACE-inhibitors) benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below
Norwegian Bokmål: For preparater som inneholder angiotensinkonverterende enyzymhemmerne (ACEhemmere) benazepril, kaptopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril og zofenopril skal eksisterende produktinformasjon oppdateres (tillegg, erstatning eller sletting av tekst der det er hensiktsmessig) slik at den gjenspeiler den godkjente ordlyden som er angitt under.
English: VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.
Norwegian Bokmål: Pasientene i VA NEPHRON-D-studien hadde type 2 diabetes mellitus og diabetisk nefropati.
English: ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage.
Norwegian Bokmål: ONTARGET-studien ble gjennomført hos pasienter med kardiovaskulær eller cerebrovaskulær sykdom i sykehistorien, eller type 2 diabetes mellitus med påvist organskade.
English: In patients whose renal function may depend on the activity of the renin-angiotensin-aldosteronesystem (e.g. patients with severe congestive heart failure), treatment with ACE-inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
Norwegian Bokmål: Hos pasienter der nyrefunksjonen er avhengig av aktiviteten til renin-angiotensinaldosteronsystemet (f.eks. hos pasienter med alvorlig hjertesvikt med stuvning), har behandling med ACE-hemmere vært forbundet med oliguri og/eller progressiv azotemi og, i sjeldne tilfeller, akutt nyresvikt og/eller dødsfall.
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.”
Norwegian Bokmål: Antall kardiovaskulære dødsfall og slag var høyere i aliskirengruppen enn i placebogruppen, og bivirkninger og alvorlige bivirkninger under spesiell oppfølging (hyperkalemi, hypotensjon og nyreskade) ble hyppigere rapportert i aliskirengruppen enn i placebogruppen.»