natgillin/translations-raw huggingface dataset:
92,9 g/m for ERT-gruppen, og den gennemsnitlige ændring fra baseline i LVMi ved måned 18 var - 6,6 (95 % CI: -11,0; -2,1; n=31) for Galafold og -2,0 (95 % CI: -11,0; 7,0; n=13) for ERT. Ændringen i LVMi (g/m2) fra baseline til måned 18 hos patienter med hypertrofi af venstre ventrikel (baseline-LVMi &gt; 95 g/m for kvinder og baseline-LVMi &gt; 115 g/m for mænd) var -8,4 (95 % CI: -15,7; 2.6; n=13) for migalastat og 4,5 (95 % CI: -10,7; 18,4; n=5) for ERT.
The change from baseline to Month 18 in LVMi (g/m 2) in patients with left ventricular hypertrophy (females with baseline LVMi &gt; 95 g/m and males with baseline LVMi &gt; 115 g/m2) was -8.4 (95% CI: -15.7, 2.6; n=13) for migalastat and 4.5 (95% CI: -10.7, 18.4; n=5) for ERT. After 30 months treatment with Galafold, the mean change from baseline in LVMi was -3.8 (95% CI: -8.9, 1.3; n=28) and the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline was -10.0 (95% CI: -16.6, -3.3; n=10).
c.837G &gt; C eller c.837G &gt; T
c.837G &gt; C or c.837G &gt; T
c.72G &gt; C eller c.72G &gt; T
c.72G &gt; C or c.72G &gt; T
c.667T &gt; A eller c.668G &gt; C
c.667T &gt; A or c.668G &gt; C
W340R c.1019G &gt; A eller c.1020G &gt; A c.G1019A eller c.G1020A W340X c.1019G &gt; C
c.1019G &gt; A or c.1020G &gt; A c.G1019A or c.G1020A
c.978G &gt; C eller c.978G &gt; T
c.978G &gt; C or c.978G &gt; T
c.288G &gt; A eller c.288G &gt; T eller c.288G &gt; C
c.288G &gt; A or c.288G &gt; T or c.288G &gt; C
c.486G &gt; C eller c.486G &gt; T
c.486G &gt; C or c.486G &gt; T
Ændring i proteinsekvens c.148T &gt; C eller c.150C &gt; G eller c.150C &gt; A
c.148T &gt; C or c.150C &gt; G or c.150C &gt; A
c.720G &gt; C eller c.720G &gt; T
c.720G &gt; C or c.720G &gt; T
c.678G &gt; T eller c.678G &gt; C
c.678G &gt; T or c.678G &gt; C
c.525C &gt; G eller c.525C &gt; A c.C525G eller c.C525A
c.C525G or c.C525A
c.729G &gt; C eller c.729G &gt; T
c.729G &gt; C or c.729G &gt; T
c.868A &gt; C eller c.868A &gt; T
c.868A &gt; C or c.868A &gt; T
c.159C &gt; G eller c.159C &gt; A c.C159G eller c.C159A
c.C159G or c.C159A
c.279C &gt; G eller c.279C &gt; A c.C279G eller c.C279A
c.C279G or c.C279A
c.886A &gt; T eller c.886A &gt; C
c.886A &gt; T or c.886A &gt; C
c.786G &gt; C eller c.786G &gt; T
c.786G &gt; C or c.786G &gt; T
c.126G &gt; A eller c.126G &gt; C eller c.126G &gt; T
Protein sequence change c.126G &gt; A or c.126G &gt; C or c.126G &gt; T
c.207C &gt; A eller c.207C &gt; G c.C207A eller c.C207G
c.207C &gt; A or c.207C &gt; G
c.139T &gt; C eller c.139T &gt; A c.T139C eller c.T139A
c.T139C or c.T139A
c.552T &gt; A eller c.552T &gt; G c.T552A eller c.T552G
c.552T &gt; A or c.552T &gt; G
c.1023A &gt; C eller c.1023A &gt; T c.A1023C eller c.A1023T
c.1023A &gt; C or c.1023A &gt; T
L344P c.1034C &gt; G eller c.1034C &gt; A c.C1034G eller c.C1034A S345X c.1042G &gt; C
c.1034C &gt; G or c.1034C &gt; A c.C1034G or c.C1034A
Ændring i proteinsekvens c.1196G &gt; A eller c.1197G &gt; A c.G1196A eller c.G1197A W399X c.1196G &gt; C
c.1196G &gt; A or c.1197G &gt; A c.G1196A or c.G1197A
c.305C &gt; G eller c.305C &gt; A c.C305G eller c.C305A
c.C305G or c.C305A
c.747C &gt; G eller c.747C &gt; A c.C747G eller c.C747A
c.C747G or c.C747A
c.258T &gt; G eller c.258T &gt; A c.T258G eller c.T258A
c.T258G or c.T258A
c.284G &gt; A eller c.285G &gt; A c.G284A eller c.G285A
c.G284A or c.G285A
W349R c.1046G &gt; A eller c.1047G &gt; A c.G1046A eller c.G1047A W349X c.1048G &gt; C
c.1046G &gt; A or c.1047G &gt; A c.G1046A or c.G1047A
c.816C &gt; A eller c.816C &gt; G c.C816A eller c.C816G
c.816C &gt; A or c.816C &gt; G
c.519C &gt; A eller c.519C &gt; G c.C519A eller c.C519G
c.519C &gt; A or c.519C &gt; G
c.1081G &gt; A eller c.1081G &gt; C c.G1081A eller c.G1081C
c.1081G &gt; A or c.1081G &gt; C
c.897C &gt; G eller c.897C &gt; A c.C897G eller c.C897A
c.C897G or c.C897A
c.241T &gt; C eller c.241T &gt; A c.T241C eller c.T241A
c.T241C or c.T241A
c.830G &gt; A eller c.831G &gt; A c.G830A eller c.G831A
c.830G &gt; A or c.831G &gt; A
c.785G &gt; A eller c.786G &gt; A c.G785A eller c.G786A
c.785G &gt; A or c.786G &gt; A
c.706T &gt; C eller c.706T &gt; A c.T706C eller c.T706A
c.T706C or c.T706A
c.485G &gt; A eller c.486G &gt; A c.G485A eller c.G486A
c.G485A or c.G486A
c.859T &gt; C eller c.859T &gt; A c.T859C eller c.T859A
c.T859C or c.T859A
c.610T &gt; C eller c.610T &gt; A c.T610C eller c.T610A
c.T610C or c.T610A
c.453C &gt; G eller c.453C &gt; A c.C453G eller c.C453A
c.C453G or c.C453A
c.456C &gt; A eller c.456C &gt; G c.C456A eller c.C456G
c.1065C &gt; A or c.1065C &gt; G c.C1065A or c.C1065G
c.894T &gt; G eller c.894T &gt; A c.T894G eller c.T894A
c.T894G or c.T894A
c.102T &gt; G eller c.102T &gt; A c.T102G eller c.T102A
c.T102G or c.T102A
c.676T &gt; C eller c.676T &gt; A c.T676C eller c.T676A
c.T676C or c.T676A
c.402T &gt; G eller c.402T &gt; A c.T402G eller c.T402A
c.T402G or c.T402A
c.960T &gt; G eller c.960T &gt; A c.T960G eller c.T960A
c.T960G or c.T960A
c.233C &gt; G eller c.233C &gt; A c.C233G eller c.C233A
c.C233G or c.C233A
Ændring i proteinsekvens c.153G &gt; A eller c.153G &gt; T eller c.153G &gt; C
c.153G &gt; A or c.153G &gt; T or c.153G &gt; C
c.131G &gt; A eller c.132G &gt; A c.G131A eller c.G132A
c.G131A or c.G132A
c.966C &gt; A eller c.966C &gt; G c.C966A eller c.C966G
c.966C &gt; A or c.966C &gt; G
c.484T &gt; C eller c.484T &gt; A c.T484C eller c.T484A
c.T484C or c.T484A
c.465T &gt; A eller c.465T &gt; G c.T465A eller c.T465G
c.465T &gt; A or c.465T &gt; G
c.1074G &gt; T eller c.1074G &gt; C c.G1074T eller c.G1074C
c.1074G &gt; T or c.1074G &gt; C
c.860G &gt; A eller c.861G &gt; A c.G860A eller c.G861A
c.860G &gt; A or c.861G &gt; A
c.408T &gt; A eller c.408T &gt; G c.T408A eller c.T408G
c.408T &gt; A or c.408T &gt; G
c.648T &gt; A eller c.648T &gt; G c.T648A eller c.T648G
c.648T &gt; A or c.648T &gt; G
c.3G &gt; A eller c.3G &gt; T eller c.3G &gt; C
c.3G &gt; A or c.3G &gt; T or c.3G &gt; C c.G3A or c.G3T or c.G3C
c.702T &gt; G eller c.702T &gt; A c.T702G eller c.T702A
c.T702G or c.T702A
c.547G &gt; A (fellermodet splejsningssted)
L177X c.547G &gt; A (putative splicing site) c.G547A (putative splicing site) UNKNOWN (G183S) c.548G &gt; T
c.242G &gt; A eller c.243G &gt; A c.G242A eller c.G243A
c.242G &gt; A or c.243G &gt; A
c.778G &gt; C eller c.778G &gt; A c.G778C eller c.G778A
c.778G &gt; C or c.778G &gt; A
Ændring i proteinsekvens c.[811G &gt; A; 937G &gt; T]
c.[811G &gt; A; 937G &gt; T]
c.834T &gt; G eller c.834T &gt; A c.T834G eller c.T834A
c.T834G or c.T834A
c.707G &gt; A eller c.708G &gt; A c.G707A eller c.G708A
c.707G &gt; A or c.708G &gt; A
c.881T &gt; G eller c.881T &gt; A c.T881G eller c.T881A
c.T881G or c.T881A
c.687T &gt; A eller c.687T &gt; G c.T687A eller c.T687G
c.687T &gt; A or c.687T &gt; G
c.789T &gt; A eller c.789T &gt; G c.T789A eller c.T789G
c.789T &gt; A or c.789T &gt; G
c.369T &gt; G eller c.369T &gt; A c.T369G eller c.T369A
c.T369G or c.T369A
c.798T &gt; A eller c.798T &gt; G c.T798A eller c.T798G
c.798T &gt; A or c.798T &gt; G
c.677G &gt; A eller c.678G &gt; A c.G677A eller c.G678A
c.677G &gt; A or c.678G &gt; A
c.666C &gt; A eller c.666C &gt; G c.C666A eller c.C666G
c.C666A or c.C666G
c.734G &gt; A eller c.735G &gt; A c.G734A eller c.G735A
c.G734A or c.G735A
c.103G &gt; C eller c.103G &gt; A c.G103C eller c.G103A
c.103G &gt; C or c.103G &gt; A
c.772G &gt; C eller c.772G &gt; A c.G772C eller c.G772A
c.772G &gt; C or c.772G &gt; A
c.801G &gt; A (fellermodet splejsningssted)
M267R c.801G &gt; A (putative splicing site) c.G801A (putative splicing site) UNKNOWN (M267I) c.803T &gt; C
Ændring i proteinsekvens c.936G &gt; T eller c.936G &gt; C
c.936G &gt; T or c.936G &gt; C
I kliniske studier responderede &gt; 90 % af patienterne på disse doser og opnåede en revertering af neutropeni på 2 dage (median).
In clinical studies, &gt; 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
Filgrastims sikkerhed og virkning hos de novo AML-patienter, som er &lt; 55 år, og som har god cytogenetik [t (8; 21), t (15; 17), og inv (16)] er ikke klarlagt.
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t(8; 21), t(15; 17), and inv(16)] have not been established.
Der er ikke observeret nogen overordnede forskelle i sikkerhed eller effekt mellem personer over 65 år i forhold til yngre voksne ( &gt; 18 år) patienter i cytotoksisk kemoterapi, og klinisk erfaring har ikke identificeret forskelle i respons mellem ældre og yngre voksne patienter.
No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult ( &gt; 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Blandt disse blev der indberettet to tilfælde af trombocyttal &lt; 50 x 10
Among these, two cases of platelets &lt; 50 x 10
Når det administreres til PBPC-mobilisering, skal behandlingen med filgrastim dog først afbrydes eller dosis reduceres, hvis leukocyttallet stiger til 70 x 10
When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to &gt; 70 x 10
I et lille antal patienter ( &lt; 10 %), var doser på op til 1,0 MU/kg/dag (10 mikrogram/kg/dag) nødvendige for at opnå revertering af neutropeni.
In a small number of patients ( &lt; 10%), doses up to 1.0 MU/kg/day (10 micrograms/kg/day) were required to achieve reversal of neutropenia.
9/l) hos 41 % af normale donorer og forbigående trombocytopeni (trombocyttal &lt; 100 x 10
9/L) was observed in 41% of normal donors and transient thrombocytopenia (platelets &lt; 100 x 10
Hvis det er nødvendigt med mere end én leukaferese, skal man være særlig opmærksom på donorer, som har et trombocyttal &lt; 100 x 10
If more than one leukapheresis is required, particular attention should be paid to donors with platelets &lt; 100 x 10
Almindelig (≥ 1/100 til
Common (≥ 1/100 to &lt;
Den anbefalede Grastofil startdosis er 0,1 ME/kg/dag (1 mikrogram/kg/dag) med titrering op til højst 0,4 ME/kg/dag (4 mikrogram/kg/dag) indtil en normalt neutrofiltal er opnået og kan opretholdes (ANC &gt; 2,0 x 10
The recommended starting dose of Grastofil is 0.1 MU/kg/day (1 micrograms/kg/day) with titration up to a maximum of 0.4 MU/kg/day (4 micrograms/kg/day) until a normal neutrophil count is reached and can be maintained (ANC &gt; 2.0 x 10
Infektioner og maligne sygdomme, som forÃ¥rsager myelosuppression Neutropeni kan skyldes opportunistiske knoglemarvsinfiltrerende infektioner som f.eks. Mycobacterium avium eller maligne sygdomme som f.eks. lymfomer.
Infections and malignancies causing myelosuppression Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Sjælden (≥ 1/10.000 til
Rare (≥ 1/10,000 to &lt;
Infusion af PBPC'er fremmer den hÃ¦matopoietiske restitution, idet perioden med risiko for hÃ¦moragiske komplikationer og behovet for trombocyttransfusioner forkortes.
Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
I kliniske studier var det nødvendigt at give 30 ME/dag (300 mikrogram/dag) i 1 til 7dage pr. uge for at opretholde et ANC &gt; 2,0 x 10
In clinical studies, dosing with 30 MU/day (300 micrograms/day) on 1 - 7 days per week was required to maintain the ANC &gt; 2.0 x 10
Intermitterende pauser i behandlingen eller nedsættelse af filgrastimdosis bør overvejes hos patienter med svær kronisk neutropeni, der udvikler trombocytopeni (tromobocyttal på &lt; 100 x 10
Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count &lt; 100 x 10
Ikke almindelig (≥ 1/1.000 til
Uncommon (≥ 1/1,000 to &lt;
Leukocytose Der er blevet observeret leukocytose (leukocyttal &gt; 50 x 10
Leukocytosis Leukocytosis (WBC &gt; 50 x 10
9/l til &gt; 5,0 x 10
&gt; 5.0 x 10
For at opretholde et ANC &gt; 2,0 x 9/l kan langtidsbehandling være nødvendig.
Long-term administration may be required to maintain the ANC &gt; 2.0 x 10
Hvis det er nødvendigt med mere end én leukaferese, skal man være særlig opmærksom på donorer, som har et trombocyttal &lt; 100 x10
If more than one leukapheresis is required, particular attention should be paid to donors with platelets &lt; 100 x 10 9/L prior to leukapheresis; in general apheresis should not be performed if platelets are
ANC &gt; 1,0x10 9/l i 3 på hinanden følgende dage
ANC &gt; 1.0 x 10
Information om, at monitoreringen kan blive forlÃ¦nget til natten over, hvis patienten oplever symptomer i lÃ¸bet af de fÃ¸rste 6 timer.
Information that the monitoring may need to extend overnight, if the patient experiences symptoms during the first 6 hours.
Desuden er de tilsvarende kategorier for hyppigheden af bivirkninger baseret på følgende konvention: 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) og meget sjælden ( &lt; 1/10.000).
In addition, the corresponding frequency category for each adverse drug reaction is based on 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).
På grund af siponimods høje plasmaproteinbinding ( &gt; 99,9 %) forventes hæmodialyse ikke at ændre koncentrationen af total og ubundet siponimod, og der forventes ikke behov for dosisjustering på baggrund af disse betragtninger.
Due to the high plasma protein binding ( &gt; 99.9%) of siponimod, haemodialysis is not expected to alter the total and unbound siponimod concentration and no dose adjustments are anticipated based on these considerations.
Der blev påvist en let tendens til reduceret FEV1 ved ikke-terapeutiske enkelte doser ( &gt; 10 mg).
A slight trend of reduced FEV1 was detected at non-therapeutic single doses ( &gt; 10 mg).
Forlænget observation ( &gt; 6 timer efter første dosis): o Hvis hjertefrekvensen efter 6 timer er på den laveste værdi efter den første dosis, forlænges monitoreringen af hjertefrekvensen i mindst 2 timer yderligere, og indtil hjertefrekvensen stiger igen.
Extended observation ( &gt; 6 hours after first dose): o If, at the 6-hour time point, the heart rate is at the lowest value following the first dose, extend heart rate monitoring for at least 2 more hours and until the heart rate increases again.
Siponimods proteinbinding er &gt; 99,9 % hos raske forsøgsdeltagere og hos patienter med nedsat lever- eller nyrefunktion.
Protein binding of siponimod is &gt; 99.9% in healthy subjects and in patients with hepatic or renal impairment.
9/l bør efter bekræftelse føre til dosisreduktion til 1 mg, fordi siponimod-dosis i kliniske studier blev reduceret hos patienter med absolut lymfocyttal &lt; 0,2 x 10
9/l, if confirmed, should lead to dose reduction to 1 mg, because in clinical studies siponimod dose was reduced in patients with absolute lymphocyte counts &lt; 0.2 x 10 9/l.
Testen identificerer to variant alleller for CYP2C9: CYP2C9*2 (rs1799853, c.430C &gt; T) og CYP2C9*3 (rs1057910, c.1075A &gt; C).
The test identifies two variant alleles for CYP2C9: CYP2C9*2 (rs1799853, c.430C &gt; T) and CYP2C9*3 (rs1057910, c.1075A &gt; C).
Et bekræftet absolut lymfocyttal &lt; 0,2 x 10
Confirmed absolute lymphocyte counts &lt; 0.2 x 10
Absolut lymfocyttal &lt; 0,2 x 10
Absolute lymphocyte counts &lt; 0.2 x 10
Siponimod er ikke blevet undersøgt hos patienter med signifikant QT-forlængelse (QTc &gt; 500 msek.)
Siponimod was not studied in patients with significant QT prolongation (QTc &gt; 500 msec) or who were treated with QT-prolonging medicinal products.
Hvis hjertefrekvensen i hvile er ≤50 slag/minut, skal behandlingen med betablokkeren afbrydes, indtil baseline-hjertefrekvensen er &gt; 50 slag/minut.
If resting heart rate is ≤50 bpm, then beta-blocker treatment should be interrupted until the baseline heart rate is &gt; 50 bpm.
Hvis hjertefrekvensen i hvile er &gt; 50 slag/minut under kronisk behandling med en betablokker, kan behandling med siponimod indledes.
If the resting heart rate is &gt; 50 bpm under chronic beta-blocker treatment, siponimod can be introduced.
Indtil 6 timer efter første dosis: o Observér patienter med sinusbradyarytmi (hjertefrekvens &lt; 55 slag/minut), anamnese med AV-blok af 1. eller 2. grad [Mobitz type I] eller tidligere myokardieinfarkt eller hjertesvigt i anamnesen (patienter med NYHA-klasse I og II) i 6 timer efter den første dosis af siponimod for tegn og symptomer på bradyarytmi og optag EKG ved afslutningen af 6-timers-monitoreringsperioden.
Until 6 hours after first dose: o Observe patients with sinus bradycardia (heart rate &lt; 55 bpm), history of first- or second-degree [Mobitz type I] AV block or a history of myocardial infarction or heart failure (patients with NYHA class I and II) for a period of 6 hours after the first dose of siponimod for signs and symptoms of bradycardia and obtain an ECG at the end of the 6-hour monitoring period.
• Krav til monitorering ved initiering af behandlingen: Inden initiering af behandling: o Vitale tegn og baseline-EKG måles inden den første dosis af siponimod hos patienter med sinusbradyarytmi (hjertefrekvens [HR] &lt; 55 slag/minut), anamnese med AV-blok af 1. eller 2. grad [Mobitz type I] eller myokardieinfarkt eller hjertesvigt i anamnesen (patienter med NYHA-klasse I og II).
• Monitoring requirements at treatment initiation: Prior to initiating treatment: o Perform vitals and baseline ECG prior to the first dose of siponimod in patients with sinus bradycardia (heart rate [HR] &lt; 55 bpm), history of first- or second-degree [Mobitz type I] AV block, or a history of myocardial infarction or heart failure (patients with NYHA class I and II).
o QTc-forlængelse &gt; 500 msek o Alvorlig ubehandlet søvnapnø o Symptomatisk bradyarytmi i anamnesen o Tilbagevendende synkope i anamnesen o Ukontrolleret hypertension o Samtidig behandling med antiarytmika klasse Ia (f.eks. kinidin,
o QTc prolongation &gt; 500 msec o Severe untreated sleep apnoea o History of symptomatic bradycardia o History of recurrent syncope o Uncontrolled hypertension o Concomitant treatment with class Ia (e.g. quinidine, procainamide) or class III anti-arrhythmic medications, calcium channel blockers (such as verapamil, diltiazem) and other medications (e.g. ivabradine or digoxin)
Tabel 2: Børn ( &lt; 40 kg) Indikation
Children ( &lt; 40 kg) Indication
De hyppigheder, der er blevet fastsat for alle andre bivirkninger (dvs. bivirkninger observeret hos &lt; 1/10.000), er overvejende fastlagt ved anvendelse af data efter markedsføring og refererer til en indberetningshyppighed snarere end til en reel hyppighed.
The frequencies assigned to all other undesirable effects (i.e. those occurring at &lt; 1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency.
Behandlingsrelaterede bivirkninger af alle grader er listet nedenfor efter systemorganklasse (i henhold til MedDRA-konventionen), hyppighed og hvor alvorlig, den er. Der er benyttet følgende konvention til klassificering af hyppigheden: 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 following convention has been utilised for the classification of frequency: 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).
Hos ældre spædbørn ( &gt; 3 uger gamle) og børn svarer cefuroxims farmakokinetik til farmakokinetikken hos voksne.
In older infants (aged &gt; 3 months) and in children, the pharmacokinetics of cefuroxime are similar to that observed in adults.
Som for alle denne type antibiotika anbefales det derfor, at dosis reduceres hos patienter med markant nedsat nyrefunktion (dvs. C1cr &lt; 30 ml/minut) for at kompensere for den langsommere udskillelse (se pkt.
Therefore, as with all such antibiotics, in patients with markedly impaired renal function (i.e. C1cr &lt; 30 mL/minute) it is recommended that the dosage of cefuroxime should be reduced to compensate for its slower excretion (see section 4.2).
Vecchi &amp; C Piam S A, Via Padre G Semeria, 5, Genoa 16131, Italien
Vecchi &amp; C Piam S A, Via Padre G Semeria, 5, Genoa 16131, Italy
THE STAR MEDICINES IMPORTERS &amp; CO LTD, POBOX 50151, 3601 LEMESOS, CYPERN
THE STAR MEDICINES IMPORTERS &amp; CO LTD, POBOX 50151, 3601
Frekvenskategorierne er defineret som følger: 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), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
Frequency categories are defined according to 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), Not known (cannot be estimated from the available data).
InfusionsoplÃ¸sningen bÃ¸r gives som en intravenÃ¸s infusion i lÃ¸bet af 20-30 minutter.
The solution for infusion is to be administrered in an intravenous infusion for 20-30 minutes.
30-40 kg Kombination med to antibiotika: Losec 20 mg, amoxicillin 750 mg og clarithromycin 7,5 mg/kg legemsvægt gives alle to gange dagligt i en uge &gt; 40 kg Kombination med to antibiotika: Losec 20 mg, amoxicillin 1 g og clarithromycin 500 mg gives alle to gange dagligt i en uge
31-40 kg Combination with two antibiotics: Losec 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight are all administrated two times daily for one week &gt; 40 kg Combination with two antibiotics: Losec 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administrated two times daily for one week.
Ældre (over 65 år) Dosisjustering er ikke nødvendig hos ældre (se pkt.
Elderly ( &gt; 65 years old) Dose adjustment is not needed in the elderly (see section 5.2).
Til forebyggelse af NSAID-associerede gastriske eller duodenale ulcera hos risikopatienter (alder &gt; 60 år, gastrisk eller duodenalt ulcus eller øvre gastrointestinal blødning i anamnesen) er den anbefalede dosis 20 mg omeprazol dagligt.
Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk For the prevention of NSAID-associated gastric ulcers or duodenal ulcers in patients at risk (age &gt; 60, previous history of gastric and duodenal ulcers, previous history of upper GI bleeding) the recommended dose is Losec 20 mg once daily.
Til forebyggelse af NSAID-associerede gastriske eller duodenale ulcera hos risikopatienter (alder &gt; 60 år, gastrisk eller duodenalt ulcus eller øvre gastrointestinal blødning i anamnesen) er den anbefalede dosis 20 mg omeprazol dagligt.
Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk For the prevention of NSAID associated gastric ulcers or duodenal ulcers in patients at risk (age &gt; 60, previous history of gastric and duodenal ulcers, previous history of upper GI bleeding) the recommended dose is Losec 20 mg once daily.
≥ 2 år &gt; 20 kg 20 mg en gang dagligt.
The dose can be increased to 20 mg once daily if needed ≥ 2 years of age &gt; 20 kg 20 mg once daily.
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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data), herunder enkeltstående indberetninger.
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), not known (cannot be estimated from the available data), including isolated reports