natgillin/translations-raw huggingface dataset:
• feber, tegn på infektion eller ekstrem træthed. 
• fever, signs of infection or extreme tiredness.
Antiretrovirale behandlinger (ART) 
Anti-retroviral therapies (ART)
Enkeltdosisundersøgelser har vist, at den orale toksicitet af ASA er lav. 
Single-dose studies have shown that the oral toxicity of ASA is low.
Du bør ikke amme, mens du tager dette lægemiddel. 
You should not breast-feed while using this medicine.
Ingen af disse analyser var tilstrækkeligt store til at kunne detektere forskelle i resultat hos personer med ringe metabolisme. 
None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Dette randomiserede, open-label studie inkluderede 2.610 biomarker-positive ACS-patienter efter vellykket PCI. 
This randomized, open-label trial included 2,610 biomarker-positive ACS patients after successful PCI.
• Tredje trimester af graviditeten (se pkt. 
• Third trimester of pregnancy (see section 4.6).
Denne fordel var konsistent på tværs af alder, køn og med eller uden fibrinolytika og blev observeret allerede efter omkring 24 timer. 
This benefit was consistent across age, gender and with or without fibrinolytics, and was observed as early as 24 hours.
Initial hyperventilation fører til respiratorisk alkalose. 
Initial hyperventilation leads to respiratory alkalosis.
Derudover kan din læge eventuelt finde ændringer i resultaterne af dine blod- eller urinprøver. 
In addition, your doctor may identify changes in your blood or urine tests.
Biotransformation og elimination 
Biotransformation and Elimination
TTP er en potentielt dødelig tilstand, der kræver øjeblikkelig behandling inklusive plasmaferese. 
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Selv om den iskæmiske fordel var konsistent i løbet af det første år, blev der observeret større reduktion i iskæmisk tilbagefald efter ACS i de første dage efter indledning af behandlingen. 
Although the ischaemic benefit was consistent throughout the first year, greater reduction in ischaemic recurrence after ACS was observed during the initial days following the treatment initiation.
Ved lave koncentrationer (< 100 mikrogram/ml) er ca. 90 % af salicylsyren bundet til albumin. 
At low concentrations (<100 micrograms/ml), approximately 90% of salicylic acid is bound to albumin.
Andre tegn på forgiftning behandles symptomatisk. 
Treat other signs of intoxication symptomatically.
Derfor bør denne kombination anvendes med forsigtighed hos patienter, der får lavdosis ASA for kardioprotektion. 
Therefore, this combination should be used with caution in patients taking low dose ASA for cardioprotection.
Det er kendt, at ASA udskilles i begrænsede mængder i human mælk. 
ASA is known to be excreted in limited amounts in human milk.
Ved mindre sår og skader, som hvis du f.eks. skærer dig under barbering, er dette som regel ikke noget problem. 
For minor cuts and injuries e.g., cutting yourself shaving, this is usually of no concern.
Varicellavaccine 
Varicella vaccine
Hyppigheden er defineret ud fra de følgende kategorier: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden < 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Mindre GI- symptomer såsom dyspepsi er almindelige og kan forekomme på alle tidspunkter under behandlingen. 
Minor GI symptoms, such as dyspepsia, are common and can occur anytime during therapy.
• hvis du har haft tidligere tilfælde af astma eller allergiske reaktioner inklusive allergi mod et lægemiddel, der anvendes til at behandle din sygdom. 
• if you have a history of asthma or allergic reactions including allergy to any medicine used to treat your disease.
Cytokrom P450 2C19 (CYP2C19 
Cytochrome P450 2C19 (CYP2C19)
Der er ikke etableret et passende dosisregime for denne patientpopulation i kliniske resultat-studier. 
An appropriate dose regimen for this patient population has not been established in clinical outcome trials.
Der findes ikke tilstrækkelig klinisk erfaring vedrørende anvendelsen af doser over 100 mg/dag og op til 500 mg/dag. 
There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day.
Blodplader er meget små bestanddele i blodet, som klumper sig sammen, når blodet størkner. 
Platelets are very small structures in the blood which clump together during blood clotting.
En patient med status nedsat metabolisme vil besidde to ikke-funktionelle alleler, som beskrevet ovenfor. 
A patient with poor metaboliser status will possess two loss-of function alleles as defined above.
• hvis du er gravid i tredje trimester. 
• if you are in your last trimester of pregnancy.
Patientpopulationen bestod af 19,7 % kvinder, og 29,2 % af patienterne var over 65 år. 
The patient population included 19.7% women and 29.2% patients ≥65 years.
- et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage. 
a planned surgery (including dental) in the next seven days.
117 Allée Des Parcs, St. Priest, 
117 Allee Des Parcs, St Priest,
Andre interaktioner med clopidogrel og ASA 
Other interactions with clopidogrel and ASA
Sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V. 
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
I CURE blev 823 (6,6 %) patienter samtidigt behandlet med GPIIb/IIIa-receptorantagonist. 
In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
• Hos patienter med akut myokardieinfarkt med elevation af ST-segmentet: Behandling bør startes så tidligt som muligt, efter symptomerne viser sig, og fortsættes i mindst 4 uger. 
• In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks.
TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) Dette randomiserede, open-label studie inkluderede ACS patienter, som kræver PCI. 
TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI.
For at behandle denne tilstand kan lægen have indopereret en stent (rør) i den blokerede eller forsnævrede blodåre (arterie) for at genoprette en effektiv blodgennemstrømning. 
For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
Ved alvorlig forgiftning forekommer der alvorlige forstyrrelser i syre-base-balancen. 
With severe intoxication, serious disturbances of the acid-base equilibrium occur.
TOPIC og TROPICALACS blev designet til at undersøge, hvordan man kan mindske blødninger, samtidig med at effekten opretholdes. 
TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
• Hvis du skærer dig eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper. 
• If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Efterfølgende forekommer respiratorisk acidose som resultat af den supprimerende effekt på respirationscentret. 
Subsequently a respiratory acidosis occurs as a result of a suppressive effect on the respiratory centre.
Ved steady state var den gennemsnitlige hæmningsgrad, der blev iagttaget ved en dosis på 75 mg/dag, mellem 40 % og 60 %. 
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
I modsætning hertil viste post-hoc analyser statistisk signifikante stigninger i blødningsrisikoen med de mere potente P2Y12- hæmmere, overvejende under vedligeholdelsesfasen efter den første måned efter ACS. 
In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month post-ACS.
Samlet set var clopidogrel 75 mg/dag sammenligneligt med ASA 325 mg/dag i CAPRIE uden hensyn til alder, køn eller race. 
Overall clopidogrel 75 mg/day was similar to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
I COMMIT var den generelle forekomst af non-cerebrale større blødninger eller cerebrale blødninger lav og ens i begge grupper. 
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups.
Depression af nervesystemet kan føre til koma, kardiovaskulært kollaps og respirationsstop. 
Depression of the nervous system can lead to coma, cardiovascular collapse and respiratory arrest.
Patienterne skal kontrolleres omhyggeligt for tegn på blødning, herunder okkult blødning, især i behandlingens første uger og/eller efter invasive hjerteindgreb eller -kirurgi. 
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
Patienter, der tidligere har udviklet en allergisk og/eller hæmatologisk reaktion over for et thienopyridin, kan have en øget risiko for at udvikle den samme eller en anden reaktion over for en anden thienopyridin. 
Patients who had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
Undersøgelser af toksicitet ved gentagne doser har vist, at niveauer op til 200 mg/kg/dag er veltolererede hos rotter; hunde er tilsyneladende mere sensitive, sandsynligvis grundet hundes høje følsomhed for ulcerogene effekter af NSAID'er. 
Repeat-dose toxicity studies have shown that levels up to 200 mg/kg/day are well tolerated in rats; dogs appear to be more sensitive, probably due to the high sensitivity of canines to the ulcerogenic effects of NSAIDs.
Blødning er den hyppigst indrapporterede bivirkning fra både kliniske studier såvel som fra postmarketing erfaring, hvor den mestendels blev indrapporteret i løbet af behandlingens første måned. 
Bleeding is the most common reaction reported both in clinical studies as well as in the post-marketing experience where it was mostly reported during the first month of treatment.
For de patienter, der ikke fik foretaget angiografi, var det primære endepunkt død, tilbagevendende myokardieinfarkt ved dag 8 eller ved udskrivelse fra hospitalet. 
For patients who did not undergo angiography, the primary endpoint was death or recurrent myocardial infarction by Day 8 or by hospital discharge.
Denne effekt varer hele trombocyttens levetid. 
This effect lasts for the life of the platelet.
Andre alleler, der associeres med fraværende eller nedsat metabolisme er mindre hyppige og inkluderer CYP2C19*4, *5, *6, *7 og *8. 
Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
• Aktiv patologisk blødning, såsom ulcus pepticum eller intrakraniel blødning. 
• Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Undersøgelser om reproduktionstoksitet viser, at ASA er teratogent hos adskillige forsøgsdyr. 
Reproduction toxicity data show that ASA is teratogenic in several laboratory animals.
McDermott Laboratories Limited trading, som Gerard Laboratories trading, som Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland 
McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Relateret til clopidogrel med frekvens ”ikke kendt”. 
** Information related to clopidogrel with frequency “not known”.
Alkalinisering af urinen (250 mmol natriumhydrogencarbonat over tre timer) under monitorering af urinens pH er indiceret. 
Alkalising of the urine (250 mmol sodium bicarbonate for 3 hours) while monitoring the urine pH is indicated.
Voksne og ældre 
Posology Adults and elderly
Dyreforsøg har ikke påvist direkte eller indirekte skadelige virkninger på graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt. 
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Acetylsalicylsyre (ASA): 
Acetylsalicylic acid (ASA):
Derfor havde den guidede deeskaleringsarm patienter behandlet med enten prasugrel (40 %) eller clopidogrel (60 %). 
Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Dets metabolit, salicylsyre, bindes i høj grad til plasmaproteiner, men dets binding er koncentrationsafhængig (non-lineær). 
Its metabolite, salicylic acid, is highly bound to plasma proteins, but its binding is concentration dependent (nonlinear).
Der er ikke fundet problemer med genotoksitet eller klastogenicitet med ASA. 
No genotoxicity or clastogenicity issues of concern have been found with ASA.
I CURE, CLARITY, ACTIVE-A og en af kohorteundersøgelserne (Trenk) blev der ikke observeret nogen øget forekomst af hændelser, baseret på metabolisk status. 
In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Nedsat hørelse eller tinnitus 
Hearing loss* or tinnitus*
• hvis du har haft en blodprop i en åre (arterie) i hjernen (iskæmisk slagtilfælde) inden for de seneste 7 dage. 
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred in the last seven days.
• antiretroviral medicin (lægemidler der anvendes til behandling af HIV-infektioner), 
• anti-retroviral medicines (medicines used to treat HIV infections)
• opioider: Når du behandles med clopidogrel, skal du fortælle det til lægen, før du får ordineret behandling med opioider. 
• opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids treatment.
Clopidogrel er blevet evalueret sikkerhedsmæssigt hos mere end 42.000 patienter, der har deltaget i kliniske studier, inklusive over 30.000 patienter behandlet med clopidogrel plus ASA og over 9.000 patienter, der blev behandlet i mindst 1 år. 
Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 30,000 patients treated with clopidogrel plus ASA, and over 9,000 patients treated for 1 year or more.
• hvis du har en lidelse, der kaldes glucose-6-phosphatdehydrogenase (G6PD)-mangel, da G6PDmangel øger risikoen for en særlig form for anæmi (lavt antal røde blodceller). 
• if you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency because of the risk of a particular form of anaemia (low number of red blood cells).
Aktivt kul (adsorbant) og natriumsulfat (laksativ) skal derefter administreres. 
Activated charcoal (adsorbent) and sodium sulphate (laxative) are then administered.
Anden samtidig behandling med ASA Der er rapporteret interaktioner med følgende lægemidler og ASA: 
Other concomitant therapy with ASA Interactions with the following medicinal products have been reported with ASA:
• hvis du er allergisk over for clopidogrel, acetylsalicylsyre eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6). 
• if you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6).
Hæmodialyse er den foretrukne behandling ved alvorlig forgiftning. 
Haemodialysis is the preferred treatment for severe intoxication.
Absorptionen er mindst 50 %, baseret på udskillelse af clopidogrels metabolitter i urinen. 
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Populationen inkluderede 27,8 % kvinder, 58,4 % af patienterne var ≥ 60 år (26 % ≥ 70 år), og 54,5 % af patienterne fik fibrinolytika. 
The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Cmax opnås ca. 3060 minutter efter administration. 
Cmax occurs approximately 30 to 60 minutes after dosing.
Lave doser (op til 100 mg/dag): 
Low doses (up to 100 mg/day):
Når personer med ringe metabolisme modtog 600 mg/150 mg regimet, var eksponeringen for den aktive metabolit større end for 300 mg/75 mg-regimet. 
When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Da den aktive metabolit dannes af CYP450-enzymer, hvoraf nogle er polymorfe eller genstand for hæmning af andre lægemidler, vil ikke alle patienter opnå tilstrækkelig trombocythæmning. 
Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by other medicinal products, not all patients will have adequate platelet inhibition.
Der er en mulig sammenhæng mellem acetylsalicylsyre (ASA) og Reyes syndrom, når lægemidler, der indeholder ASA, gives til børn og unge med en virusinfektion. 
There is a possible association between acetylsalicylic acid (ASA) and Reye's Syndrome when products containing ASA are given to children or adolescents with a viral infection.
Heparin blev givet til over 90 % af patienterne, og den relative blødningsforekomst i grupperne clopidogrel plus ASA og ASA alene blev ikke signifikant påvirket af den ledsagende heparinbehandling. 
Heparins were administered in more than 90% of the patients and the relative rate of bleeding between clopidogrel plus ASA and ASA alone was not significantly affected by the concomitant heparin therapy.
C-mærket clopidogrel hos mennesker blev ca. 50 % udskilt i urinen og ca. 46 % i fæces i løbet af 120 timer efter dosering. 
C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Urikosurika (benzbromaron, probenecid, sulfinpyrazon) Der skal udvises forsigtighed, da ASA kan hæmme effekten af urikosurika via kompetitiv elimination af urinsyre. 
Uricosurics (benzbromarone, probenecid, sulfinpyrazone) Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Lejlighedsvis anvendelse af acetylsalicylsyre (ikke over 1.000 mg over en periode på 24-timer) burde generelt ikke give problemer, men hvis du tager acetylsalicylsyre gennem længere tid under andre omstændigheder, skal du diskutere det med lægen eller apotekspersonalet. 
An occasional use of ASA (no more than 1,000 mg in any 24-hour period) should generally not cause a problem, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.
Patienter bør også informeres om, at det kan tage længere tid end normalt at standse blødninger, når de tager Clopidogrel/Acetylsalicylic acid Mylan, samt at de bør kontakte deres læge ved enhver usædvanlig blødning (sted eller varighed). 
Patients should also be told that it might take longer than usual to stop bleeding when they take Clopidogrel/Acetylsalicylic acid Mylan, and that they should report any unusual bleeding (site or duration) to their physician.
De de-eskalerede patienter gennemgik testning høj trombocytreaktivitet (HPR) test. 
The de-escalated patients underwent high platelet reactivity (HPR) testing.
Den publicerede forekomst af CYP2C19-genotyper med ringe metabolisme er ca. 2 % for kaukasiske personer, 4 % for negroide og 14 % for kinesiske. 
Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Filmovertrukket tablet (tablet) 
Film coated tablet (tablet)
Der er dog foretaget et antal retrospektive analyser for at evaluere denne effekt hos patienter i behandling med clopidogrel, for hvem der foreligger resultater af genotypebestemmelse: CURE (n = 2721), CHARISMA (n = 2428), CLARITY- TIMI 28 (n = 227), TRITON-TIMI 38 (n = 1477) og ACTIVE-A (n = 601) såvel som et antal publicerede kohorteundersøgelser. 
There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Baseret på de farmakokinetiske og metabolske karakteristika af begge stoffer er klinisk signifikante farmakokinetiske interaktioner ikke sandsynlige. 
Based on the pharmacokinetic and metabolic characteristics of both compounds, clinically significant PK interactions are unlikely.
Ved moderat forgiftning kan det forsøges at fremprovokere opkastning; ventrikeltømning er indiceret, hvis dette mislykkes. 
With moderate intoxication an attempt can be made to induce vomiting; if this fails, gastric lavage is indicated.
Skift fra en mere potent P2Y12 receptorhæmmer til clopidogrel i association med aspirin efter akut fase i ACS er blevet evalueret i to randomiserede investigator-sponsorerede studier (ISS) - TOPIC og TROPICAL-ACS - med kliniske outcome data. 
Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS)TOPIC and TROPICAL-ACS - with clinical outcome data.
Hæmning af prostaglandinsyntesen kan have negativ indvirkning på graviditeten og/eller udviklingen af embryo/foster. 
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development.
Der var ikke tegn på carcinogen virkning, når clopidogrel blev administreret i 78 uger til mus og 104 uger til rotter og givet i doser op til 77 mg/kg/dag (hvilket repræsenterer mindst 25 gange eksponeringen hos mennesker, der får den kliniske dosis på 75 mg/dag). 
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Dette var konsistent blandt undergrupperne af patienter, defineret ved baseline-karakteristika og typen af fibrinolytika- eller heparinbehandling. 
This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
- et nyligt kirurgisk indgreb (gælder også tandoperationer). 
a recent surgery (including dental).
Den anbefalede dosis er 1 tablet Clopidogrel/Acetylsalicylic acid Mylan dagligt, som indtages gennem munden med et glas vand, med eller uden mad. 
The recommended dose is one tablet of Clopidogrel/Acetylsalicylic acid Mylan per day to be taken orally with a glass of water, with or without food.
Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. tablet, dvs. den er i det væsentlige 'natriumfrit'. 
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Desuden er der beskrevet øgede forekomster af forskellige misdannelser, inklusive kardiovaskulære misdannelser, ved indgift af prostaglandinsyntesehæmmere til dyr under den organogenetiske periode. 
In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
Kliniske studier tyder på, at anvendelse af doser op til 100 mg om dagen til begrænset obstetrisk anvendelse i forbindelse med specialiseret monitorering er sikker. 
Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
Sikkerhed og virkning af clopidogrel/acetylsalicylsyre hos børn og unge under 18 år er endnu ikke fastslået. 
The safety and efficacy of clopidogrel/acetylsalicylic acid in children and adolescents under 18 years old have not been established.