FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose adjustments of calcium channel blockers when coadministered with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
Danish: Dosisjustering af calciumantagonister, når disse administreres samtidigt med Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, bør styres af klinisk respons (se produktresuméet for calciumantagonisten).
English: Cmax: ↓ 37% (↓ 20 to ↓ 51) Cmin: ↓ 44% (↓ 27 to ↓ 58) (decrease in itraconazole concentrations: CYP3A4 induction)
Danish: AUC: ↓ 39% (↓ 21 til ↓ 53) Cmax: ↓ 37% (↓ 20 til ↓ 51) Cmin: ↓ 44% (↓ 27 til ↓ 58) (fald i itraconazolkoncentrationerne: CYP3A4-induktion)
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and vigabatrin or gabapentin can be coadministered without dose adjustment.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka og vigabatrin eller gabapentin kan administreres samtidigt uden dosisjustering.
English: Adverse reactions associated with the use of efavirenz/emtricitabine/tenofovir disoproxil
Danish: Brug af anden medicin sammen med Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
English: If you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
Danish: Hvis du holder op med at tage Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
English: Saquinavir/ritonavir/Tenofovir disoproxil
Danish: Saquinavir/ritonavir/tenofovirdisop roxil
English: Pack sizes: 30 film coated tablets (1x30) and 90 film-coated tablets (3x30).
Danish: Pakningsstørrelser: Fås i pakninger, der indeholder 30 filmovertrukne tabletter og 90 (3 flasker med 30) filmovertrukne tabletter.
English: nausea
Danish: Leversvigt
English: Emtricitabine: AUC: ↔ Cmax: ↔
Danish: Emtricitabin: AUC: ↔ Cmax: ↔
English: These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particulary neurologic findings, These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Danish: Mitokondriel dysfunktion bør overvejes hos alle børn med svære kliniske symptomer af ukendt ætiologi, især neurologiske symptomer, der har været eksponeret for nukleosid-/nukleotid-analoger in utero.
English: Insufficient data are available to make a dosing recommendation for indinavir when dosed with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
Danish: Der er kun utilstrækkelige data til doseringsanbefaling for indinavir, når dette doseres sammen med Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Dose adjustment of warfarin or acenocoumarol may be required when co-administered with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
Danish: Justering af buprenorphin-dosis er muligvis ikke nødvendig, når det administreres samtidigt med Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25)
Danish: AUC: ↓ 34% (↓ 41 til ↓ 25) Cmax: ↓ 34% (↓ 41 til ↑ 25) Cmin: ↓ 34% (↓ 43 til ↑ 24)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka bør ikke anvendes til patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 50 ml/min).
English: Emtricitabine: AUC: ↔ Cmax: ↔ C24h: ↔
Danish: Emtricitabin: AUC: ↔ Cmax: ↔ C24t: ↔
English: As Efavirenz/Emtricitabine/Tenofovir disoproxil Krka may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Danish: Da Efavirenz/Emtricitabine/Tenofovir disoproxil Krka kan forårsage nyreskader, anbefales monitorering af nyrefunktionen (se pkt.
English: Co-administration of Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka with sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/ voxilaprevir is not recommended (see section 4.4).
Danish: Samtidig administration af Efavirenz/Emtricitabine/Tenofovir disoproxil Krka og sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/ voxilaprevir frarådes (se pkt.
English: GMR=geometric least-squares mean ratio, CI=confidence interval
Danish: Værdierne for Test og Reference er gennemsnitlige (% variationskoefficient) GMR: Ratio af middelværdi fundet ved geometriske mindste kvadraters metode, CI=konfidensinterval
English: Your doctor may do blood tests to see if your kidneys are working properly softening of the bones (with bone pain and sometimes resulting in fractures) which may occur due to damage to the kidney tubule cells fatty liver
Danish: Kalktab fra knoglerne (med knoglesmerter, som nogle gange resulterer i knoglebrud), som kan forekomme på grund af beskadigelse af de tubulære celler i nyrerne Fedtlever
English: Do not breast-feed during treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Danish: Du må ikke amme under behandling med Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Dose adjustments of diltiazem when coadministered with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka should be guided by clinical response (refer to the Summary of Product Characteristics for diltiazem).
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, bør justering af diltiazem-dosis styres af klinisk respons (se produktresumé for diltiazem).
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and sofosbuvir can be coadministered without dose adjustment
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka og sofosbuvir kan administreres samtidigt uden dosisjustering
English: (N=104)
Danish: Tidligere NNRTIbaseret behandling (N=104)
English: HIV/HBV or HCV co-infected patients
Danish: Patienter som samtidigt er inficerede med hiv+HBV eller hiv+HCV:
English: ANTICONVULSANTS Carbamazepine/Efavirenz (400 mg q.d./600 mg q.d.)
Danish: ANTIEPILEPTIKA Carbamazepin/efavirenz (400 mg q.d./600 mg q.d.)
English: Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives, see section 4.5) while on therapy with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Danish: Barrierekontraception bør altid anvendes sammen med andre kontraceptiva (f.eks. orale eller andre hormonkontraceptiva, se pkt.
English: The safety and efficacy of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka in children under the age of 18 years have not been established (see section 5.2).
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krkas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt (se pkt.
English: Musculoskeletal and connective tissue disorders: Very common elevated creatine kinase
Danish: Knogler, led, muskler og bindevæv: Meget almindelig
English: (including acute interstitial nephritis) nephrogenic diabetes insipidus
Danish: 4, nefrogen diabetes insipidus
English: breakdown of muscle, muscle pain or weakness anaemia (low red blood cell count) a feeling of spinning or tilting (vertigo), whistling, ringing or other persistent noise in the ears blurred vision chills breast enlargement in males decreased sexual drive flushing dry mouth increased appetite
Danish: Snurrende eller gyngende fornemmelse (svimmelhed), piben, ringen eller anden vedblivende støj i ørerne
English: Bone effects
Danish: Knogleeffekter
English: if you are allergic to efavirenz, emtricitabine, tenofovir disoproxil or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Efavirenz/Emtricitabine/Tenofovir disoproxil Krka hvis du er allergisk over for efavirenz, emtricitabin, tenofovir, tenofovirdisoproxil eller et af de øvrige indholdsstoffer i Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (angivet i punkt 6).
English: Antifungals
Danish: Mundtørhed
English: If Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is stopped your doctor may recommend that you resume hepatitis B treatment.
Danish: Hvis du holder op med at tage Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, kan din læge anbefale, at du genoptager behandling for hepatitis B. Du kan have behov for blodprøver efter 4 måneder for at tjekke hvor godt din lever fungerer.
English: Concomitant use not recommended
Danish: Samtidig administration frarådes
English: Efavirenz/emtricitabine/tenofovir disoproxil should be administered with caution to patients with mild hepatic impairment (see sections 4.3 and 4.4).
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil bør administreres med forsigtighed til patienter med let nedsat leverfunktion (se pkt.
English: Recommendation concerning co-administration with Efavirenz/Emtricitabine/Tenof ovir disoproxil Krka (efavirenz 600 mg, emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (efavirenz 600 mg, emtricitabin 200 mg, tenofovirdisoproxil 245 mg)
English: 3, affect lability confusional state aggression
Danish: 3, ataksi unormal koordination agitation
English: Plasma trough concentrations of boceprevir were decreased when administered with efavirenz, a component of
Danish: Dal-plasmakoncentrationen af boceprevir blev reduceret, når det blev administreret sammen med efavirenz, et aktivt stof i Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: allergic reactions disturbances of coordination and balance feeling worried or depressed difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness pain, stomach pain problems with digestion resulting in discomfort after meals, feeling bloated, wind (flatulence) loss of appetite tiredness itching changes in skin colour including darkening of the skin in patches often starting on hands and soles of feet
Danish: Mavesmerter fremkaldt af betændelse i bugspytkirtlen Glemsomhed, forvirring, krampeanfald, usammenhængende tale, rysten (tremor) Gulfarvning af hud eller øjne, kløe eller mavesmerter fremkaldt af betændelse i leveren Beskadigelse af de tubulære celler i nyrerne
English: Paroxetine: AUC: ↔ Cmax: ↔ Cmin: ↔
Danish: Paroxetin: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Methadone: AUC: ↔ Cmax: ↔ Cmin: ↔
Danish: Metadon: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and paroxetine can be co-administered without dose adjustment.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka og paroxetin kan administreres uden dosisjustering.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and fluoxetine can be co-administered without dose adjustment.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka og fluoxetin kan administreres uden dosisjustering.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Danish: MINDSTEKRAV TIL MÆRKNING PÅ DEN INDRE EMBALLAGE
English: Lopinavir/ritonavir/Emtricitabine Interaction not studied.
Danish: Lopinavir/ritonavir/emtricitabin Interaktion er ikke undersøgt.
English: There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP isozymes with efavirenz.
Danish: Når Efavirenz/Emtricitabine/Tenofovir disoproxil Krka administreres sammen med et plasmakoncentrationer, phenobarbital og andre krampestillende lægemidler, som er substrater for CYP-isozymer, er mulig med efavirenz.
English: Rosuvastatin/Tenofovir disoproxil Interaction not studied.
Danish: Carbamazepin/ tenofovirdisoproxil Interaktion er ikke undersøgt.
English: Common fatigue pain, asthenia
Danish: Diarré, opkastning, kvalme
English: Coadministration of lopinavir/ritonavir and Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka is not recommended.
Danish: Samtidig administration af lopinavir/ritonavir og Efavirenz/Emtricitabine/Tenofovir disoproxil Krka frarådes.
English: If a patient misses a dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka within 12 hours of the time it is usually taken, the patient should take Efavirenz/Emtricitabine/Tenofovir disoproxil Krka as soon as possible and resume the normal dosing schedule.
Danish: Hvis en patient glemmer at tage en dosis Efavirenz/Emtricitabine/Tenofovir disoproxil Krka i mindre end 12 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage
English: What Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is and what it is used for What you need to know before you take Efavirenz/Emtricitabine/Tenofovir disoproxil Krka How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Possible side effects
Danish: Det skal du vide, før du begynder at tage Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Sådan skal du tage Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Bivirkninger
English: IJ
Danish: GMR
English: Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction)
Danish: AUC: ↓ 52% (↓ 33 til ↓ 66) Cmax: ↓ 45% (↓ 25 til ↓ 59) (CYP3A4-induktion)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is contraindicated in patients with severe hepatic impairment (see section 4.3) and not recommended in patients with moderate hepatic impairment.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka er kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: Hepatic impairment
Danish: Nedsat sexlyst
English: That patients should have their baseline renal function assessed prior to initiating Efavirenz/Emtricitabine /Tenofovir disoproxil Krka therapy The importance of regular monitoring of renal function during Efavirenz/Emtricitabine /Tenofovir disoproxil Krka therapy
Danish: - At patienterne bør have deres nyrefunktion ved baseline vurderet før behandling med Efavirenz/Emtricitabine/Tenofovir disoproxil Krka initieres - Vigtigheden af regelmæssig monitorering af nyrefunktionen i løbet af behandling med Efavirenz/Emtricitabine/Tenofovir disoproxil Krka - Anbefalet skema for monitorering af nyrefunktion, med hensyntagen til tilstedeværelsen eller fraværet af yderligere risikofaktorer for nedsat nyrefunktion - Hvis serumphosphat er < 1,5 mg/dl eller kreatininclearance reduceres til < 50 ml/min under behandlingen, skal nyrefunktionen revurderes inden for en uge.
English: Co-administration of atazanavir/ritonavir and Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka a is not recommended.
Danish: Samtidig administration af atazanavir/ritonavir og Efavirenz/Emtricitabine/Tenofovir disoproxil Krka frarådes.
English: Fosamprenavir/ritonavir/Tenofovir disoproxil
Danish: Fosamprenavir/ritonavir/tenofovird isoproxil
English: Cmax: ↑ 49% (↑ 32 to ↑ 69)
Danish: AUC: ↑ 34% (↑ 18 til ↑ 53) Cmax: ↑ 49% (↑ 32 til ↑ 69)
English: Insufficient safety data are available for children below 18 years of age.
Danish: Opbevares utilgængeligt for børn.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka, Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka should not be administered concomitantly with lamivudine (see section 4.4).
Danish: Grundet ligheden mellem lamivudin og emtricitabin, en Efavirenz/Emtricitabine/Tenofovir disoproxil Krkakomponent, bør Efavirenz/Emtricitabine/Tenofovir disoproxil Krka ikke gives samtidigt med lamivudin (se pkt.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and raltegravir can be co-administered without dose adjustment.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka og raltegravir kan administreres samtidigt uden dosisjustering.
English: Darunavir/ritonavir/Emtricitabine Interaction not studied.
Danish: Darunavir/ritonavir/emtricitabin Interaktion er ikke undersøgt.
English: Efavirenz levels may increase on stopping St. John's wort.
Danish: Efavirenz-koncentrationen kan stige, når perikon seponeres.
English: Uncommon rhabdomyolysis muscular weakness
Danish: Rabdomyolyse muskelsvækkelse
English: Since
Danish: I
English: Combination of emtricitabine and tenofovir disoproxil
Danish: Kombination af emtricitabin og tenofovirdisoproxil:
English: potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Danish: Højere tenofovirkoncentrationer kan forstærke tenofovir-associerede bivirkninger inklusive nyrelidelser.
English: saquinavir/ritonavir and Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka is not recommended.
Danish: Samtidig administration af saquinavir/ritonavir og Efavirenz/Emtricitabine/Tenofovir disoproxil Krka frarådes.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and rosuvastatin can be coadministered without dose adjustment.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka og rosuvastatin kan administreres samtidigt uden dosisjustering.
English: Vigabatrin/Efavirenz
Danish: Vigabatrin/efavirenz Gabapentin/efavirenz
English: studied in combination with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
Danish: 4.5) under behandling med Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Carbamazepine/Tenofovir disoproxil
Danish: Posaconazol/ tenofovirdisoproxil
English: If you take more Efavirenz/Emtricitabine/Tenofovir disoproxil Krka than you should
Danish: Hvis du har taget for meget Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
English: Rare photoallergic dermatitis angioedema
Danish: Abdominalsmerter, abdominal distension, flatulens
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and fosamprenavir/ritonavir can be co-administered without dose adjustment.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka og fosamprenavir/ritonavir kan administreres samtidigt uden dosisjustering.
English: With regard to safety, the Agency noted an acceptable safety profile and did not identify any substantial safety issue.
Danish: Hvad angår sikkerheden konstaterede agenturet, at sikkerhedsprofilen var acceptabel, og fandt ingen væsentlige sikkerhedsproblemer.
English: Repatha received a marketing authorisation valid throughout the EU on 17 July 2015.
Danish: Repatha fik en markedsføringstilladelse med gyldighed i hele EU den 17. juli 2015.
English: Further information on Repatha can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Repatha findes på agenturets websted under:ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: As for all medicines, data on the use of Repatha are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Repatha løbende overvåget.
English: If the desired response is not achieved after 12 weeks of treatment, the dose can be increased up to 420 mg every two weeks.
Danish: Hvis den ønskede virkning ikke opnås efter 12 ugers behandling, kan dosis forøges op til 420 mg hver anden uge.
English: Patients can self-administer the medicine once they have been properly trained.
Danish: Patienter kan selv tage lægemidlet, når de er blevet grundigt instrueret.
English: Other information about Repatha
Danish: Andre oplysninger om Repatha
English: Repatha can also be used without a statin in patients who cannot take statins.
Danish: Repatha kan også anvendes uden et statin hos patienter, der ikke kan tåle statiner.
English: What measures are being taken to ensure the safe and effective use of Repatha?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Repatha?
English: The European Medicines Agency decided that Repatha's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Repatha opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The Agency also noted that for patients with homozygous familial disease there are limited treatment options, and these patients have a higher risk of cardiovascular disease.
Danish: Agenturet bemærkede også, at der for patienter med homozygot familiær sygdom er begrænsede behandlingsmuligheder, og at disse patienter har højere risiko for kardiovaskulære sygdomme.
English: For more information about using Repatha, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Repatha, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Repatha are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Repatha vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: This helps to reduce the amount of cholesterol in the blood.
Danish: Dette bidrager til at nedsætte kolesterolmængden i blodet.
English: An overview of Repatha and why it is authorised in the EU
Danish: En oversigt over Repatha og hvorfor det er godkendt i EU
English: The active substance in Repatha, evolocumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to an enzyme called ‘PCSK9'.
Danish: Det aktive stof i Repatha, evolocumab, er et monoklonalt antistof (en type protein), som er fremstillet, så det genkender og binder til et enzym kaldet "PCSK9".
English: The cartridges are to be used together with an automated dosing device called a mini-doser.
Danish: Cylinderampullerne skal anvendes sammen med en automatisk doseringsindretning kaldet en minidoserer.
English: Repatha contains the active substance evolocumab.
Danish: Repatha indeholder det aktive stof evolocumab.
English: These studies found a substantial reduction in blood levels of LDL-cholesterol (around 60 to 70% more than placebo, and of around 40% more than ezetimibe) from week 10 to week 12 of the study and at the end of 12 weeks.
Danish: Disse studier viste en væsentlig nedsættelse af LDL-kolesterolindholdet i blodet (ca. 60 til 70 % mere end placebo og ca. 40 % mere end ezetimibe) fra undersøgelsens uge 10 til 12 og ved afslutningen af uge 12.
English: A second study showed that long-term use of Repatha achieved a sustained reduction of fat levels in the blood in these patients during 28 weeks of treatment.
Danish: En anden undersøgelse viste, at langtidsanvendelse af Repatha bevirkede en vedvarende nedsættelse af fedtindholdet i blodet hos disse patienter i løbet af 28 ugers behandling.
English: They received either Repatha or placebo, both with an optimal fat-lowering therapy, for over 2 years on average.
Danish: De har fået enten Repatha eller placebo, begge sammen med optimal fedtstofnedsættende behandling, i gennemsnit i 2 år.
English: By attaching and blocking PCSK9, Repatha prevents the receptors from being broken down and therefore increases their numbers on the cell surface, where they can attach to LDL-cholesterol and remove it from the bloodstream.
Danish: Ved at bindes til PCSK9 og blokere det forhindrer Repatha receptorerne i at blive nedbrudt og øger derfor antallet af dem på celleoverfladen, hvor de kan bindes til LDL-kolesterol og fjerne dette fra blodbanen.
English: What is Repatha and what is it used for?
Danish: Hvad er Repatha, og hvad anvendes det til?
English: Why is Repatha authorised in the EU?
Danish: Hvorfor blev Repatha godkendt i EU?
English: Before starting treatment with Repatha, other causes of excess cholesterol and abnormal fat levels in blood should be ruled out.
Danish: Før påbegyndelsen af behandlingen med Repatha bør andre årsager til forhøjet kolesterol og unormalt højt fedtindhold i blodet udelukkes.
English: In the Repatha group, less than 10% (1,344 of 13,784 patients) had a cardiovascular event (meaning death, heart attack, stroke, hospitalization or surgery due to problems with the blood flow to the heart) during the study compared with just over 11% in the placebo group (1,563 of 13,780 patients).
Danish: I Repatha-gruppen kom under 10 % (1 344 af 13 784 patienter) i løbet af undersøgelsen ud for en hjerte-kar-hændelse (dvs. død, hjerteanfald, slagtilfælde, indlæggelse eller operation i forbindelse med problemer med blodforsyningen til hjertet), sammenholdt med lidt over 11 % i placebogruppen (1 563 af 13 780 patienter).
English: Some studies compared Repatha with placebo (a dummy treatment) and others to another medicine (ezetimibe).
Danish: Nogle studier sammenlignede Repatha med placebo (en virkningsløs behandling) og andre med et andet lægemiddel (ezetimibe).