natgillin/translations-raw huggingface dataset:
Inden for systemorganklassen er bivirkninger opstillet ifølge hyppighed ved hjælp af den 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), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Within the system organ class, the adverse reactions are listed by frequency 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) and not known (cannot be estimated from the available data).
I et klinisk studie, der var beregnet til at vurdere eksponeringen for granisetron fra SANCUSO hos personer med forskellige niveauer af kropsfedt, hvor BMI bruges som en surrogatmarkør for kropsfedt, blev der ikke set nogen forskel i SANCUSOs farmakokinetik i plasma hos mandlige og kvindelige personer med et lavt BMI [ &lt; 19,5 kg/m2 (mænd), &lt; 18,5 kg/m2 (kvinder)] og et højt BMI (30,0 til og med 39,9 kg/m2), sammenlignet med en kontrolgruppe (BMI 20,0 til og med 24,9 kg/m2).
In a clinical study designed to assess granisetron exposure from SANCUSO in subjects with differing levels of body fat, using BMI as a surrogate measure for body fat, no differences were seen in the plasma pharmacokinetics of SANCUSO in male and female subjects with a low BMI [ &lt; 19.5 kg/m2 (males), &lt; 18.5 kg/m2 (females)] and a high BMI (30.0 to 39.9 kg/m2 inclusive) compared to a control group (BMI 20.0 to 24.9 kg/m2inclusive).
b Baseret på patienter med PASI &gt; 2.5 ved baseline for IMPACT, og patienter med &gt; 3% BSA psoriasis hud påvirkning ved baseline af IMPACT 2.
b Based on patients with PASI &gt; 2.5 at baseline for IMPACT, and patients with &gt; 3% BSA psoriasis skin involvement at baseline in IMPACT 2.
Inflectra er et biosimilÃ¦rt lÃ¦gemiddel.
Inflectra is a biosimilar medicinal product.
Inflectra-infusioner skal administreres af kvalificeret sundhedspersonale, som er trÃ¦net i at detektere infusionsrelaterede problemer.
Inflectra infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Inflectra bÃ¸r administreres
Inflectra should be administered
Inflectra bruges ogsÃ¥ til voksne og bÃ¸rn fra 6 Ã¥r og opefter til behandling af:
Inflectra is also used in adults and children 6 years of age or older for:
Inflectra tilhÃ¸rer en medicingruppe kaldet âTNF-blokkereâ.
Inflectra belongs to a group of medicines called âTNF blockers'.
Infliximab passerer placenta og er blevet sporet i i serum hos spÃ¦dbÃ¸rn op til 6 mÃ¥neder efter fÃ¸dslen.
Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Infliximab skal administreres intravenÃ¸st over en 2-timers periode.
Infliximab should be administered intravenously over a 2 hour period.
Inflectra opbevares af sundhedspersonalet pÃ¥ hospitalet eller klinikken.
Inflectra will generally be stored by the health professionals at the hospital or clinic.
Inflectra bÃ¸r kun anvendes til bÃ¸rn, hvis de behandles for Crohns sygdom eller colitis ulcerosa.
Inflectra should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Inflectra fremstilles i pakninger med 1, 2, 3, 4 eller 5 hÃ¦tteglas.
Inflectra is produced in packs of 1, 2, 3, 4, or 5 vials.
Inflectra pÃ¥virker sandsynligvis ikke din evne til at fÃ¸re motorkÃ¸retÃ¸j eller betjene vÃ¦rktÃ¸j eller maskiner.
Inflectra is not likely to affect your ability to drive or use tools or machines.
178 af de 580 inkluderede patienter (30,7%) blev defineret som havende svær sygdom (CDAI score &gt; 300 og samtidig kortikoid og/eller immunsupprimerende behandling) svarende til populationen defineret i indikationen (se pkt.
178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score &gt; 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Der forekom én alvorlig infusionsrelateret reaktion ( &lt; 1%) hos en patient på infliximab monoterapi.
One serious infusion reaction ( &lt; 1%) occurred in a patient on infliximab monotherapy.
InfusionsvÃ¦sken skal administreres over en periode pÃ¥ ikke mindre end den anbefalede infusionstid (se pkt.
The infusion solution has to be administered over a period of not less than the infusion time recommended (see section 3).
Infliximab bÃ¸r anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II).
Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
Inflectra er indiceret til behandling af aktiv og progressiv psoriasis arthritis hos voksne patienter, hvor respons pÃ¥ tidligere DMARD-behandling har vÃ¦ret utilstrÃ¦kkelig.
Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Inflectra pÃ¥virker i mindre grad evnen til at fÃ¸re motorkÃ¸retÃ¸j og betjene maskiner.
Inflectra may have a minor influence on the ability to drive and use machines.
I uge 16 blev 47 placebopatienter med &lt; 10% forbedring fra udgangspunktet i både hævede og ømme led flyttet til infliximab induktion (tidlig overflytning).
At week 16, 47 placebo patients with &lt; 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
Inflectra bÃ¸r undersÃ¸ges visuelt for partikler eller misfarvning fÃ¸r indgivelsen.
Inflectra should be visually inspected for particulate matter or discolouration prior to administration.
I genbehandlingsarmen fik 4% (8/219) af patienterne en alvorlig infusionsrelateret reaktion sammenlignet med &lt; 1% (1/222) på vedligeholdelsesbehandling.
In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus &lt; 1% (1/222) on maintenance therapy.
Infliximab er et kimÃ¦risk humant-murint monoklonalt antistof, der binder sig med hÃ¸j affinitet til bÃ¥de oplÃ¸selige og transmembrane former af TNFÎ±, men ikke til lymphotoxin Î± (TNFÃ).
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFÎ± but not to lymphotoxin Î± (TNFÎ²).
Infliximab forebyggede sygdom hos transgene mus, der udvikler polyarthritis som resultat af konstitutiv ekspression af human TNFÎ±, og fik ved administration efter sygdomsstart eroderede led til at heles.
Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFÎ± and when administered after disease onset, it allowed eroded joints to heal.
Ved 54 uger var 44,9% af patienterne i den kombinerede infliximab-behandlingsgruppe i klinisk respons sammenlignet med 19,8% i placebobehandlingsgruppen (p &lt; 0,001).
At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p &lt; 0.001).
Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate &gt; 5%, indbefatter pneumocystose, candidiasis, listeriose og aspergillose.
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of &gt; 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
d p = 0,030 og &lt; 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX.
d p = 0.030 and &lt; 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs.
Inflectra er indiceret til behandling af svÃ¦r, aktiv ankyloserende spondylitis hos voksne patienter, som har responderet utilstrÃ¦kkeligt pÃ¥ konventionel behandling.
Inflectra is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Inflectra indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det vÃ¦sentlige natriumfrit.
Inflectra contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially âsodium-free'.
Inflectra er dog fortyndet i en natriumchloridoplÃ¸sning 9 mg/ml (0,9%) til infusion.
Inflectra is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Inflectra administreres intravenÃ¸st.
Inflectra should be administered intravenously.
I SPIRIT var andelen af patienter, der opnåede PASI 75 i uge 10 71,7% i 3 mg/kg infliximab-gruppen, 87,9% i 5 mg/kg infliximab-gruppen og 5,9% i placebogruppen (p &lt; 0,001).
In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p &lt; 0.001).
Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate &gt; 5%, indbefatter pneumocystose, candidiasis, listeriose og aspergillose (se pkt.
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of &gt; 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4).
I uge 54 var tallene 55,8% (29/52) og 23,5% (12/51) for henholdsvis 8-ugers gruppen og 12-ugers gruppen (p &lt; 0,001).
At week 54, the figures were 55.8% (29/52) and 23.5% (12/51) in the q8 weeks and q12 weeks maintenance groups, respectively (p &lt; 0.001).
Inflectra kan opbevares ved temperaturer pÃ¥ op til hÃ¸jst 25Â°C i en enkelt periode pÃ¥ op til 6 mÃ¥neder, men den oprindelige udlÃ¸bsdato mÃ¥ ikke overskrides.
Inflectra may be stored at temperatures up to a maximum of 25 Â°C for a single period of up to 6 months, but not exceeding the original expiry date.
I uge 12 var antallet af BASDAI 50 respondere 3/35 (9%) i placebogruppen og 20/35 (57%) i 5 mg/kg gruppen (p &lt; 0,01).
At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p &lt; 0.01).
Infliximabs virkning og sikkerhed blev undersÃ¸gt i to multicenter, dobbelblindede, placebokontrollerede studier hos patienter med aktiv ankyloserende spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scoreâ¥ 4 og spinalsmerte â¥ 4 pÃ¥ en skala pÃ¥ 1-10)
Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Inflectra er indiceret til behandling af moderat til svÃ¦r plaque psoriasis hos voksne patienter, som ikke responderede pÃ¥, eller som har en kontraindikation for eller som ikke tÃ¥ler anden systemisk behandling inklusive ciclosporin, methotrexat eller psoralen ultra-violet A (PUVA) (se pkt.
Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Infliximabs sikkerhed og virkning blev vurderet i et multicenter, randomiseret, open-label, parallelgruppe klinisk studie (C0168T72) hos 60 pÃ¦diatriske patienter i alderen 6 til 17 Ã¥r (medianalder 14,5 Ã¥r) med moderat til svÃ¦r aktiv colitis ulcerosa (Mayo-score pÃ¥ 6-12; endoskopisk subscore â¥ 2) med utilstrÃ¦kkeligt respons pÃ¥ konventionel behandling.
The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
En større andel patienter i den kombinerede infliximab-behandlingsgruppe var i stand til at afbryde kortikosteroider og stadig blive i klinisk remission sammenlignet med placebobehandlingsgruppen i både uge 30 (22,3% mod 7,2%, p &lt; 0,001, samlede ACT 1 &amp; ACT 2 data) og uge 54 (21,0% mod 8,9%, p=0,022, ACT 1 data).
A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p &lt; 0.001, pooled ACT 1 &amp; ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Infliximabvedligeholdelse 5 mg/kg (n=113) (p-vÃ¦rdi)
Infliximab Maintenance 5 mg/kg (n=113) (p value)
Infliximabvedligeholdelse 10 mg/kg (n=112) (p-vÃ¦rdi)
Infliximab Maintenance 10 mg/kg (n=112) (p value)
I uge 24 var antallet af ASAS 20 respondere 15/78 (19%) i placebogruppen og 123/201 (61%) i gruppen, der fik 5 mg/kg infliximab (p &lt; 0,001).
At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p &lt; 0.001).
Andelen af patienter med slimhindeheling i uge 26 var signifikant større i grupperne, der fik infliximab plus AZA (43,9%; p &lt; 0,001) eller infliximab-monoterapi (30,1%; p=0,023) sammenlignet med AZA-monoterapigruppen (16,5%).
The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p &lt; 0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
I uge 4 efter indgivelse af en enkelt dosis opnåede 22/27 (81%) af de infliximab-behandlede patienter, der fik 5 mg/kg dosen en klinisk virkning mod 4/25 (16%) af placebopatienterne (p &lt; 0,001).
At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p &lt; 0.001).
Andelene af patienter i vedvarende respons og vedvarende remission i uge 54 var større i den kombinerede infliximab-behandlingsgruppe end i placebobehandlingsgruppen (henholdsvis 37,9% mod 14,0%, p &lt; 0,001 og 20,2% mod 6,6%, p &lt; 0,001).
The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p &lt; 0.001; and 20.2% vs. 6.6%, p &lt; 0.001, respectively).
b CDAI &lt; 150 ved både uge 30 og 54.
b CDAI &lt; 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54
Klinisk remission og slimhindeheling forekom i en større andel af patienterne i den kombinerede infliximabbehandlingsgruppe sammenlignet med placebobehandlingsgruppen i uge 54 (henholdsvis 34,6% mod 16,5%, p &lt; 0,001 og 46,1% mod 18,2%, p &lt; 0,001).
Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p &lt; 0.001 and 46.1% vs. 18.2%, p &lt; 0.001, respectively).
Infliximab med eller uden AZA blev vurderet i et randomiseret, dobbeltblindet studie med aktiv komparator (SONIC) hos 508 voksne patienter med moderat til svÃ¦r Crohns sygdom (CDAI â¥ 220 â¤ 450).
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI â¥ 220 â¤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Inflectra er indiceret til behandling af moderat til svÃ¦r, aktiv colitis ulcerosa hos voksne patienter, som har haft utilstrÃ¦kkelig respons af konventionel behandling inklusive kortikosteroider og 6-mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kliniske kontraindikationer for sÃ¥danne behandlinger.
Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Gennemsnit ± SD a p &lt; 0,001, for hver infliximab-behandlingsgruppe mod kontrol.
Mean ± SDd a p &lt; 0.001, for each infliximab treatment group vs control.
Inflectra er indiceret til behandling af svÃ¦r, aktiv Crohns sygdom hos bÃ¸rn og unge mellem 6 og 17 Ã¥r, som ikke har responderet pÃ¥ konventionel behandling inklusive kortikosteroid, immunmodulator og primÃ¦r ernÃ¦ringsbehandling, eller som er intolerante over for eller hvor der er kontraindikationer mod sÃ¥danne behandlinger.
Inflectra is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Inflectra er indiceret til behandling af svÃ¦r, aktiv colitis ulcerosa hos bÃ¸rn og unge i alderen 6 til 17 Ã¥r, som har responderet utilstrÃ¦kkeligt pÃ¥ konventionel behandling, inklusive kortikosteroider og 6-MP eller AZA, eller som er intolerante over for eller hvor der er kontraindikationer mod disse behandlinger.
Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
I uge 4 opnåede endvidere 13/27 (48%) af infliximab-behandlede patienter en klinisk remission
Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI &lt; 150) vs. 1/25 (4%) of placebo-treated patients.
Inflectra 100 mg pulver til koncentrat til infusionsvÃ¦ske, oplÃ¸sning infliximab
Inflectra 100 mg powder for concentrate for solution for infusion infliximab
Inflectra leveres som et hÃ¦tteglas (glasflaske) indeholdende et pulver til koncentrat til infusionsvÃ¦ske, oplÃ¸sning.
What Inflectra looks like and contents of the pack Inflectra is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Slimhindeheling i uge 30 a p &lt; 0,001, for hver infliximab-behandlingsgruppe mod placebo.
a a p &lt; 0.001, for each infliximab treatment group vs. placebo.
Uge50 a p &lt; 0,001, for hver infliximab-behandlingsgruppe versus kontrol.
a p &lt; 0.001, for each infliximab treatment group vs. control.
b Alle infliximab doser er givet i kombination med methotrexat og folat samt eventuelt kortikosteroider og/eller NSAIDs c p &lt; 0,001, for hver infliximab-behandlingsgruppe versus kontrol d Større værdier indikerer mere uarbejdsdygtighed.
b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or
Inflectra 100 mg pulver til koncentrat til infusionsvÃ¦ske, oplÃ¸sning.
Inflectra 100 mg powder for concentrate for solution for infusion
Kreatininstigninger på &gt; 50 % fra baseline.)
Creatinine increases of &gt; 50% from baseline.)
90 % af patienterne havde en endelig påvirkning af IPA på &gt; 70 % 2 timer efter dosering.
90% of patients had final extent IPA &gt; 70% by 2 hours post dose.
Frekvenser fra laboratorieobservationer (Urinsyrestigninger til &gt; øvre normalgrænse fra baseline under eller inden for referenceområde.
Frequencies derived from lab observations (Uric acid increases to &gt; upper limit of normal from baseline below or within reference range.
Hyppigheden er opdelt i følgende kategorier: Meget almindelig (≥1/10), almindelig (≥1/100 til 1/10), ikke almindelig (≥1/1.000 til 1/100), sjælden (≥1/10.000 til 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 conventions: Very common (≥1/10), common (≥1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Der var ingen beviser for fordele (ingen reduktion af det primære sammensatte endepunkt for CV-død, MI og apopleksi, men en stigning i major bleeding) når ticagrelor 60 mg to gange dagligt blev givet til klinisk stabile patienter &gt; 2 år fra MI eller mere end et år efter seponering af tidligere behandling med en ADP-receptorhæmmer (se også pkt.
There was no evidence of benefit (no reduction in the primary composite endpoint of CV death, MI and stroke, but an increase in major bleeding) when ticagrelor 60 mg twice daily was introduced in clinically stable patients &gt; 2 years from the MI, or more than one year after stopping previous ADP receptor inhibitor treatment (see also section 4.2).
Eksponeringen for ticagrelor var ca. 20 % lavere og eksponeringen for den aktive metabolit var ca. 17 % højere hos patienter med svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min) sammenlignet med forsøgspersoner med normal nyrefunktion.
Exposure to ticagrelor was approximately 20% lower and exposure to the active metabolite was approximately 17% higher in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) compared to subjects with normal renal function.
Baseret på et forhold observeret i PLATO mellem vedligeholdelsesdosis af ASA og relativ effekt af ticagrelor sammenlignet med clopidogrel bør ticagrelor ikke administreres samtidig med høje vedligeholdelsesdoser af ASA ( &gt; 300 mg) (se pkt.
Based on a relationship observed in PLATO between maintenance ASA dose and relative efficacy of ticagrelor compared to clopidogrel, co-administration of ticagrelor and high maintenance dose ASA ( &gt; 300 mg) is not recommended (see section 5.1).
Ticagrelor 60 mg seponeredes hyppigere på grund af blødning og dyspnø hos patienter på &gt; 75 år end hos yngre patienter (interval: 23-31 %) med en forskel versus placebo, der var større end 10 % (42 % versus 29 %) hos patienter &gt; 75 år.
The rate of discontinuations with ticagrelor 60 mg due to bleeding and dyspnoea was higher in patients &gt; 75 years (42%) than in younger patients (range: 23-31%), with a difference versus placebo higher than 10% (42% vs. 29%) in patients &gt; 75 years.
Major Fatal/Life-threatening Bleed: Klinisk åbenbar med en reduktion på &gt; 50 g/l af hæmoglobin eller ≥4 infunderede erytrocytenheder; eller fatal; eller intrakraniel; eller intraperikardiel med hjertetamponade; eller med hypovolæmisk shock eller svær hypotension, der kræver pressorstoffer eller operation.
Major Fatal/Life-threatening Bleed: Clinically apparent with &gt; 50 g/L decrease in haemoglobin or ≥4 red cell units transfused; or fatal; or intracranial; or intrapericardial with cardiac tamponade; or with hypovolaemic shock or severe hypotension requiring pressors or surgery.
PLATO Major Fatal/life-threatening: Fatal blødning, ELLER en intrakraniel blødning, ELLER intraperikardiel med hjertetamponade, ELLER med hypovolæmisk shock eller svær hypotension, der kræver pressorstoffer/inotroper eller operation ELLER klinisk åbenlys med &gt; 50 g/l fald i hæmoglobin eller ≥4 infunderede erytrocytenheder.
PLATO Major Fatal/life-threatening: Fatal bleeding, OR any intracranial bleeding, OR intrapericardial with cardiac tamponade, OR with hypovolaemic shock or severe hypotension requiring pressors/inotropes or surgery OR clinically apparent with &gt; 50 g/L decrease in haemoglobin or ≥4 red cell units transfused.
TIMI Major Bleed: Klinisk åbenbar med en reduktion på &gt; 50 g/l af hæmoglobin eller intrakraniel blødning.
TIMI Major Bleed: Clinically apparent with &gt; 50 g/L decrease in haemoglobin or intracranial haemorrhage.
Samtidig brug af MicardisPlus og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR &lt; 60 ml/min/1,73 m2) (se pkt.
The concomitant use of MicardisPlus with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).