natgillin/translations-raw huggingface dataset:
Patienter med kreatininclearance under 50 ml/min har øget risiko for blødning og VTE, hvorfor der skal udvises forsigtighed ved behandling (se pkt.
Patients with creatinine clearance &lt; 50 ml/min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
Ca. 40 % af patienterne havde let nedsat nyrefunktion (kreatininclearance ≥50 og &lt; 80 ml/min), og ca. 17 % havde moderat nedsat nyrefunktion (kreatinclearance ≥30 og &lt; 50 ml/min).
Approximately 40% and 17% of patients had mild (creatinine clearance ≥50 to &lt; 80 ml/min) or moderate (creatinine clearance ≥30 to &lt; 50 ml/min) renal impairment, respectively.
Ca. 40 % af patienterne havde let nedsat nyrefunktion (kreatininclearance ≥50 til &lt; 80 ml/min), og ca. 14 % havde moderat nedsat nyrefunktion (kreatininclearence ≥30 til &lt; 50 ml/min).
Approximately 40% and 14% of patients had mild (creatinine clearance ≥50 to &lt; 80 ml/min) or moderate (creatinine clearance ≥30 to &lt; 50 ml/min) renal impairment, respectively.
• Behandling af UA/NSTEMI og STEMI - Fondaparinux må ikke anvendes til patienter med kreatininclearance &lt; 20 ml/min (se pkt.
• Treatment of UA/NSTEMI and STEMI - Fondaparinux should not be used in patients with creatinine clearance &lt; 20 ml/min (see section 4.3).
- aktiv klinisk betydende blødning - akut bakteriel endokardit - alvorlig nedsat nyrefunktion defineret som kreatininclearance &lt; 20 ml/min.
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance &lt; 20 ml/min.
For at undgå VTE er de bivirkninger, der blev rapporteret af investigator, og som i hvert fald muligvis kan tilskrives fondaparinux, anført efter hyppigheden af hændelsen (meget almindelig ≥1/10; almindelig ≥1/100 - &lt; 1/10; ikke almindelig ≥1/1.000 - &lt; 1/100; sjælden ≥1/10.000 - &lt; 1/1.000; meget sjælden &lt; 1/10.000) og inden for hver organklasse efter aftagende sværhedsgrad.
For the prevention of VTE, the adverse reactions reported by the investigator as at least possibly related to fondaparinux are presented within each frequency grouping (very common ≥ 1/10; common: ≥1/100 to &lt; 1/10; uncommon: ≥ 1/1,000 to &lt; 1/100; rare: ≥ 1/10,000 to &lt; 1/1,000; very rare &lt; 1/10,000) and system organ class by decreasing order of seriousness; these adverse reactions should be interpreted within the surgical and medical context.
• Forebyggelse af VTE - Fondaparinux må ikke anvendes til patienter med kreatininclearance &lt; 20 ml/min (se pkt.
• Prevention of VTE - Fondaparinux should not be used in patients with creatinine clearance &lt; 20 ml/min (see section 4.3).
• Behandling af superficiel venetrombose - Fondaparinux bør ikke anvendes til patienter med kreatininclearance &lt; 20 ml/min (se pkt.
• Treatment of superficial-vein thrombosis - Fondaparinux should not be used in patients with creatinine clearance &lt; 20 ml/min (see section 4.3).
- aktiv klinisk betydende blødning - akut bakteriel endokardit - alvorlig nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min).
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance &lt; 30 ml/min.
Det primære effektmål blev signifikant reduceret fra 5,9 % hos placebopatienterne til 0,9 % i den gruppe, der fik fondaparinux 2,5 mg [relativ risiko-reduktion: 85,2 %; 95 % CI, 73,7 % til 91,7 % (p &lt; 0,001)].
The primary efficacy outcome, a composite of symptomatic PE, symptomatic DVT, symptomatic superficial-vein thrombosis extension, symptomatic superficial-vein thrombosis reoccurrence, or Death up to Day 47, was significantly reduced from 5.9% in placebo patients to 0.9% in those receiving fondaparinux 2.5 mg (relative risk reduction: 85.2%; 95% CIs, 73.7% to 91.7% [p &lt; 0.001]).
Produktet forårsager en langvarig hæmning af aktiviteten af ACE i plasma hos hunde med mere end 95% hæmning ved maksimalt niveau og vedvarende signifikant aktivitet ( &gt; 80%) 24 timer efter tildelingen.
The product causes a long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity ( &gt; 80%) persisting 24 hours after dosing.
Infusionen varer mindst Ã©n time, og dosen afhÃ¦nger af patientens kropsvÃ¦gt.
The infusion lasts at least one hour and the dose depends on the patient's bodyweight.
Informationsmaterialet til patienter vil ogsÃ¥ indeholde oplysninger om, hvordan Stelara injiceres under huden.
The patient material will also include details of how Stelara should be injected under the skin.
Hyppigheden af uønskede hændelser anført nedenfor defineres i henhold til følgende konventioner: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til &lt; 1/10); ikke almindelig (≥ 1/1.000 til &lt; 1/100); sjælden (≥ 1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000).
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000).
Det primære formål med forsøget var at sammenligne andelen af patienter hvis SeDBT var kontrolleret (SeDBT &lt; 90 mmHg) ved Uge 5.
The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP &lt; 90 mmHg) at Week 5 of treatment.
Der er set begrænset akkumulering af irbesartan ( &lt; 20%) i plasma efter gentagne doseringer, 1 gang dagligt.
Limited accumulation of irbesartan ( &lt; 20%) is observed in plasma upon repeated once-daily dosing.
Ambarès &amp; Lagrave F-33565 Carbon Blanc Cedex - Frankrig
Ambarès &amp; Lagrave F-33565 Carbon Blanc Cedex - France
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès &amp; Lagrave F-33565 Carbon Blanc Cedex Frankrig
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès &amp; Lagrave F-33565 Carbon Blanc Cedex France
Nonsteroide antiinflammatoriske lægemidler: Når angiotensin II-antagonister administreres samtidig med nonsteroide antiinflammatoriske lægemidler (fx selektive COX-2-hæmmere, acetylsalicylsyre ( &gt; 3 g/dag) og non-selektive NSAID) kan den antihypertensive virkning svækkes.
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid ( &gt; 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
47,2% af patienterne i kombinationsbehandling nåede et dal-SeDBT &lt; 90 mmHg sammenlignet med 33,2% af patienterne behandlet med irbesartan (p = 0,0005).
Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP &lt; 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
På grund af hydrochlorthiazid-komponenten anbefales CoAprovel ikke til patienter med alvorlig nyreinsufficiens (kreatininclearance &lt; 30 ml/min).
Due to the hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal dysfunction (creatinine clearance &lt; 30 ml/min).
Alvorlig leverfunktionsnedsættelse, biliær cirrhose og cholestase Samtidig behandling med CoAprovel og aliskiren-holdige lægemidler er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) &lt; 60 ml/min/1,73 m2 ) (se pkt.
Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of CoAprovel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) &lt; 60 ml/min/1.73 m²) (see sections 4.5 and 5.1).
Faldet i SeSBT/SeDBT ved 5 uger var henholdsvis 30,8/24,0 mmHg og 21,1/19,3 mmHg for irbesartan/hydrochlorothiazid og irbesartan (p &lt; 0,0001).
The mean baseline blood pressure was approximately 172/113 mmHg in each treatment group and decreases of SeSBP/SeDBP at five weeks were 30.8/24.0 mmHg and 21.1/19.3 mmHg for irbesartan/hydrochlorothiazide and irbesartan, respectively (p &lt; 0.0001).
CoAprovel må ikke anvendes til patienter med alvorlig nyrefunktionsnedsættelse (kreatininclearance &lt; 30 ml/min) (se pkt.
CoAprovel should not be used in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) (see section 4.3).
6.1 eller over for andre sulfonamidderivater (hydrochlorthiazid er et sulfonamidderivat) Graviditet i 2. eller 3. trimester (se pkt.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance &lt; 30 ml/min) Refractory hypokalaemia, hypercalcaemia
Dog skal denne faste dosis-kombination gives med forsigtighed til patienter med mild til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min, men &lt; 60 ml/min).
However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but &lt; 60 ml/min) this fixed dose combination should be administered with caution.
AUC er 50% højere hos ældre ( &gt; 65 år) end hos yngre individer.
The AUC is 50% higher in elderly ( &gt; 65 years) than in young subjects.
Bivirkningerne (tabel 1) er ordnet i frekvensgrupper med den mest almindelige først og ved anvendelse af følgende definition: Meget almindelig (≥1/10); almindelig (≥1/100 til &lt; 1/10); ikke almindelig (≥1/1.000 til &lt; 1/100); sjælden (≥1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, &lt; 1/10); uncommon (≥1/1,000, &lt; 1/100); rare (≥1/10,000, &lt; 1/1,000); very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
Hypotension var også usædvanlig ( &lt; 1 %) under kombinationsbehandling med andre antihypertensiva.
Hypotension was also uncommon ( &lt; 1%) during combination therapy with other antihypertensive agents.
I et studie udført hos hæmodialyse-patienter med nyresygdom i slutstadie (end stage renal disease, ESRD), var clearencedialyse af aliskiren lav ( &lt; 2 % oral clearence).
In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low ( &lt; 2% of oral clearance).
Sprimeo er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/l eller 1,70 mg/dl hos kvinder og ≥ 177 μmol/l eller 2,00 mg/dl hos mænd og/eller estimeret GFR &lt; 30 ml/min./1,73 m2), tidligere dialyse, nefrotisk syndrom eller renovaskulær hypertension.
In clinical studies Sprimeo has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR &lt; 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Aliskirens eventuelle gavnlige virkning på hjerte-kar og/eller nyrer blev undersøgt i et dobbeltblindt, placebokontrolleret, randomiseret studie hos 8.606 patienter med type 2-diabetes og kronisk nyresygdom (vist ved proteinuri og/eller GFR &lt; 60 ml/min./1,73m2) med eller uden hjerte-karsygdom.
Aliskiren was evaluated for cardiovascular and/or renal benefit in a double-blind placebo controlled randomised trial in 8,606 patients with type 2 diabetes and chronic kidney disease (evidenced by proteinuria and/or GFR &lt; 60 ml/min/1.73 m2) with or without cardiovascular disease.
Sprimeo kan anvendes alene eller kombineres med andre antihypertensiva dog ikke i kombination med angiotensin-konverteringsenzym (ACE)-hæmmere eller angiotensin-II receptorblokkere (ARB) hos patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationsrate (GFR) &lt; 60 ml/min./1,73 m
Sprimeo may be used alone or in combination with other antihypertensive agents with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) &lt; 60 ml/min/1.73 m
Sprimeo anbefales ikke til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationsrate (GFR) &lt; 30 ml/min./1,73 m2).
Sprimeo is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) &lt; 30 ml/min/1.73 m2).
Sprimeo anbefales ikke til patienter med stærkt nedsat nyrefunktion (GFR &lt; 30 ml/min./1,73 m2).
Sprimeo is not recommended in patients with severe renal impairment (GFR &lt; 30 ml/min/1.73 m2).
Samtidig brug af aliskiren og ACE-hæmmere eller ARB'er er kontraindiceret hos patienter med nedsat nyrefunktion (GFR &lt; 60 ml/min./1,73 m2).
The concomitant use of aliskiren and ACEIs or ARBs is contraindicated in patients with renal impairment (GFR &lt; 60 ml/min/1.73 m2).
Anvendelse af aliskiren i kombination med ARB'er eller ACE-hæmmere er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR &lt; 60 ml/min./1,73 m2) (se pkt.
The use of aliskiren in combination with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see section 4.3).
Sprimeo frarådes til patienter med stærkt nedsat nyrefunktion (GFR &lt; 30 ml/min./1,73 m
Sprimeo is not recommended in patients with severe renal impairment (GFR &lt; 30 ml/min/1.73 m
Kombination af aliskiren med ARB'er eller ACE-hæmmere er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (GFR &lt; 60 ml/min./1,73 m2) og frarådes til andre patienter
The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) and is not recommended in other patients
Samtidig brug af Sprimeo og ARB'er eller ACE-hæmmere er kontraindiceret hos patienter med nedsat nyrefunktion (GFR &lt; 60 ml/min./1,73 m2) (se pkt.
Concomitant use of Sprimeo with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see section 4.3).
Kombination af aliskiren med ARB'er eller ACE-hæmmere er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (GFR &lt; 60 ml/min./1,73 m2) og frarådes til andre patienter (se pkt.
The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 4.3,
Frekvenserne defineres som: Meget almindelig (1/10); almindelig (1/100 til &lt; 1/10); ikke almindelig (1/1.000 til &lt; 1/100); sjælden (1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
p &lt; 0,001 sammenlignet med placebo eller placebo + kombinationsbehandling.
p &lt; 0.001 compared to placebo or placebo + combination treatment.
Patienter med eGFR &lt; 30 ml/min/1,73 m2 blev ikke inkluderet i studiet.
Patients with an eGFR &lt; 30 mL/min/1.73 m2 were not to be enrolled in the study.
Behandling baseret på stratum- (anvendelse af metformin og insulin), interaktioner var ikke signifikant (p &gt; 0,10).
Treatment by stratum (metformin and insulin use) interactions were not significant (p &gt; 0.10).
Denne undersøgelse omfattede 423 patienter med kronisk nyreinsufficiens (estimeret glomerulær filtrationshastighed &lt; 50 ml/min).
This study involved 423 patients with chronic renal impairment (estimated glomerular filtration rate &lt; 50 ml/min).
I en anden undersøgelse med 91 patienter med type 2-diabetes og kronisk nyreinsufficiens (kreatininclearance &lt; 50 ml/min) var sikkerhed og tolerabilitet for sitagliptinbehandling med 25 eller 50 mg en gang dagligt generelt den samme som for placebo.
In another study involving 91 patients with type 2 diabetes and chronic renal impairment (creatinine clearance &lt; 50 ml/min), the safety and tolerability of treatment with sitagliptin at 25 or 50 mg once daily were generally similar to placebo.
Merck Sharp &amp; Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU Storbritannien
Merck Sharp &amp; Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU United Kingdom
Studiepopulationen bestod af 2.004 patienter ≥ 75 år og 3.324 patienter med nedsat nyrefunktion (eGFR &lt; 60 ml/min/1,73 m
The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR &lt; 60 mL/min/1.73 m
I løbet af studiet var den samlede estimerede gennemsnitlige forskel (standardafvigelse (SD)) i HbA1c mellem sitagliptingruppen og placebogruppen 0,29% (0,01), 95% CI (-0,32; -0,27); p &lt; 0,001.
Over the course of the study, the overall estimated mean (SD) difference in HbA1c between the sitagliptin and placebo groups was 0.29 % (0.01), 95 % CI (-0.32, -0.27); p &lt; 0.001.
Sammenlignet med normale raske kontrolpersoner steg sitagliptins plasma-AUC med henholdsvis ca. 1,2 gange og 1,6 gange hos patienter med let nyreinsufficiens (GFR ≥60 til &lt; 90 ml/min) og patienter med moderat nyreinsufficiens (GFR ≥45 til &lt; 60 ml/min).
Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased by approximately 1.2-fold and 1.6-fold in patients with mild renal impairment (GFR ≥ 60 to &lt; 90 mL/min) and patients with moderate renal impairment (GFR ≥ 45 to &lt; 60 mL/min), respectively.
Til patienter med svær nyreinsufficiens (GFR ≥15 til &lt; 30 ml/min) eller med nyresygdom i slutstadiet (ESRD) (GFR &lt; 15 ml/min), inklusive patienter som har behov for hæmodialyse eller peritonealdialyse, er dosis 25 mg Ristaben en gang dagligt.
For patients with severe renal impairment (GFR ≥ 15 to &lt; 30 mL/min) or with end-stage renal disease (ESRD) (GFR &lt; 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Ristaben is 25 mg once daily.
Sitagliptins plasma-AUC steg med ca. det dobbelte hos patienter med moderat nyreinsufficiens (GFR ≥30 til &lt; 45 ml/min) og med ca. det firdobbelte hos patienter med svær nyreinsufficiens (GFR &lt; 30 ml/min), inklusive patienter med ESRD i hæmodialyse.
Plasma AUC of sitagliptin was increased approximately 2-fold in patients with moderate renal impairment (GFR ≥ 30 to &lt; 45 mL/min), and approximately 4-fold in patients with severe renal impairment (GFR &lt; 30 mL/min), including in patients with ESRD on haemodialysis.
TECOS-studiet (The Trial Evaluating Cardiovascular Outcomes with Sitagliptin) inkluderede 7.332 patienter, som blev behandlet med sitagliptin 100 mg dagligt (eller 50 mg dagligt, hvis eGFR ved baseline var ≥ 30 og &lt; 50 ml/min/1,73 m2), og 7.339 patienter, som fik placebo, i intention to treat-populationen.
The Trial Evaluating Cardiovascular Outcomes with sitagliptin (TECOS) included 7,332 patients treated with sitagliptin, 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and &lt; 50 mL/min/1.73 m2), and 7,339 patients treated with placebo in the intention-to-treat population.
Til patienter med moderat nyreinsufficiens (GFR ≥30 til &lt; 45 ml/min) er dosis 50 mg Ristaben en gang dagligt.
For patients with moderate renal impairment (GFR  30 to &lt; 45 mL/min), the dose of Ristaben is 50 mg once daily.
Derudover var osteoartritis og ekstremitetssmerter medtaget under de bivirkninger, som blev rapporteret uden hensyntagen til årsagssammenhæng med lægemidlet og som forekom hyppigere hos patienter i behandling med sitagliptin (som ikke nåede niveauet på 5%, men som forekom med en incidens, der var &gt; 0,5% højere med sitagliptin i forhold til incidensen i kontrolgruppen).
Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5 % level, but occurring with an incidence of &gt; 0.5 % higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
Til patienter med let nyreinsufficiens (glomerulær filtrationsrate [GFR] 60 til &lt; 90 ml/min) er dosisjustering ikke nødvendig.
For patients with mild renal impairment (glomerular filtration rate [GFR]  60 to &lt; 90 ml/min), no dose adjustment is required.
Til patienter med moderat nyreinsufficiens (GFR 45 til &lt; 60 ml/min) er dosisjustering ikke nødvendig.
For patients with moderate renal impairment (GFR  45 to &lt; 60 mL/min), no dosage adjustment is required.
For at opnå den samme plasmakoncentration for sitagliptin som hos patienter med normal nyrefunktion bør patienter med GFR &lt; 45 ml/min have lavere doser (se pkt.
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR &lt; 45 mL/min (see section 4.2).
Indehaver af markedsføringstilladelsen Merck Sharp &amp; Dohme B.V.
Marketing Authorisation Holder Merck Sharp &amp; Dohme B.V. Waarderweg 39
Patienterne fik sitagliptin (7.332) 100 mg dagligt (eller 50 mg dagligt, hvis eGFR ved baseline var ≥ 30 og &lt; 50 ml/min/1,73 m2) eller placebo (7.339) som supplement til standardbehandling målrettet de regionale standarder for HbA1c og kardiovaskulære risikofaktorer.
The TECOS was a randomised in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0 % with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and &lt; 50 mL/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
For at opnå den samme plasmakoncentration for sitagliptin som hos patienter med normal nyrefunktion bør patienter med GFR &lt; 45 ml/min samt ESRD-patienter med behov for hæmodialyse eller peritonealdialyse have lavere doser (se pkt.
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR &lt; 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis (see section 4.2 and 5.2).
Dosisjustering af Ristaben er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (Child-Pugh score ≤9).
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score &gt; 9).
Hyppighed defineres i henhold til følgende konvention: almindelig ( &gt; 1/100 til &lt; 1/10); ikke almindelig ( &gt; 1/1.000 til &lt; 1/100); sjælden ( &gt; 1/10.000 til &lt; 1/1.000); meget sjælden
Their frequency is defined using the following conventions: common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000).
CAPRIE-studiet omfattede 19.185 patienter med aterotrombose manifesteret ved nyligt myokardieinfarkt ( &lt; 35 dage), nyligt iskæmisk apopleski (mellem 7 dage og 6 måneder) eller påviste perifere kredsløbsforstyrrelser (PAD).
The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction ( &lt; 35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
DATO FOR ÆNDRING AF TEKSTEN &lt; MM/ÅÅÅÅ &gt;
This leaflet was last approved in MM/YYYY.
Almindelige (≥ 1/100 til &lt; 1/10), ikke almindelige (≥ 1/1.000 til &lt; 1/100) og sjældne (≥ 1/10.000 til &lt; 1/1.000) bivirkninger, som optrådte hos patienter, der blev behandlet med febuxostat, er opstillet nedenfor.
Common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100) and rare (≥1/10,000 to &lt; 1/1,000) adverse reactions occurring in patients treated with febuxostat are listed below.