FrancophonIA/ELRC3.0 huggingface dataset:
English: In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin and liver enzymes, hepatocellular vacuolation and hypertrophy, and, in female mice only, hepatic single-cell necrosis.
Danish: I toksicitetsstudier med gentagne doser på mus, rotter og hunde var atazanavirrelaterede fund generelt begrænset til leveren og omfattede generelt minimale til milde forhøjelser af serum bilirubin og leverenzymer, hepatocellulær vacuolation og hypertrofi, og kun i hunmus hepatisk enkeltcellenekrose.
English: If you notice any of these symptoms please inform your doctor.
Danish: Hvis du bemærker et eller flere af disse symptomer, skal du informere lægen.
English: Four subjects in the unboosted atazanavir group and 2 in the atazanavir + ritonavir group had HIV RNA > 500 copies/ml during the maintenance phase.
Danish: 4 forsøgspersoner i gruppen med ikke-boostet atazanavir og 2 forsøgspersoner i gruppen med atazanavir + ritonavir havde HIVRNA > 500 kopier/ml i vedligeholdelsesfasen.
English: Difference estimate [95% CI]
Danish: Afvigelsesestimate [95% KI]
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Danish: Hyppigheden af behandlingsrelateret hepatitis eller transaminaseforhøjelser hos samtidigt inficerede patienter var sammenlignelig mellem atazanavir og sammenlignelige regimer (se pkt.
English: Alternative antiretroviral therapy to Atazanavir Mylan may be considered if jaundice or scleral icterus is unacceptable to a patient.
Danish: Anden antiretroviral behandling end Atazanavir Mylan kan overvejes såfremt gulsot eller scleral icterus ikke er acceptabelt for patienten.
English: Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
Danish: b Ti patienter havde baseline fænotyperesistens over for atazanavir + ritonavir (foldændring [FC]>5,2).
English: Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when co-administered with protease inhibitors.
Danish: Selvom det ikke er undersøgt, er der risiko for en øget pravastatin- eller fluvastatineksponering ved administration sammen med proteasehæmmere.
English: If you accidentally take more Atazanavir Mylan capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Danish: Hvis du ved en fejltagelse har taget for mange Atazanavir Mylan -kapsler, skal du kontakte din HIVlæge eller nærmeste hospital og bede om råd.
English: 3rd Trimester (n=20)
Danish: 3. trimester (n=20)
English: No dosage adjustment is needed in patients with renal impairment.
Danish: Dosisjustering er ikke påkrævet hos patienter med nedsat nyrefunktion.
English: Your doctor will discuss with you which combination of these medicines with Atazanavir Mylan is best for you.
Danish: Lægen vil tale med dig om, hvilken kombination af anden medicin og Atazanavir Mylan , der er bedst for dig.
English: Fifteen of 120 (13%) patients in the atazanavir + ritonavir treatment arm and 17 of 123 (14%) patients in the lopinavir + ritonavir arm had four or more of the PI substitutions L10, M46, I54, V82, I84, and L90.
Danish: Femten ud af 120 (13%) patienter i atazanavir + ritonavir-behandlingsarmen og 17 ud af 123 (14%) patienter i lopinavir + ritonavir-armen havde fire eller flere af PI-substitutionerne L10, M46, I54, V82, I84 og L90.
English: ACID REDUCING AGENTS H2-Receptor antagonists
Danish: H2-receptorantagonister
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are yet unknown.
Danish: Det vides endnu ikke, hvordan høj systemisk fluticasoneksponering påvirker ritonavir-plasmaniveauet.
English: McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Danish: McDermott Laboratories under forretningsnavnet Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irland
English: Co-administration with simvastatin or lovastatin (see section 4.5).
Danish: Samtidig administration af simvastatin eller lovastatin (se pkt.
English: Increased plasma concentrations of quetiapine may lead to coma (see section 4.3).
Danish: Forhøjet plasmakoncentration af quetiapin kan medføre koma (se pkt.
English: Asymptomatic first- and second-degree AV block was reported in paediatric patients (see section 4.8).
Danish: Asymptomatisk 1. og 2. grads AV-blok blev rapporteret hos pædiatriske patienter (se pkt.
English: Itraconazole
Danish: Itraconazol
English: Your doctor will evaluate how severe your liver disease is before deciding whether you can take Atazanavir Mylan
Danish: Lægen vurderer, hvor omfattende leversygdommen er, inden det afgøres, om du kan bruge Atazanavir Mylan .
English: The atazanavir/ritonavir arm showed similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48 (Table 5).
Danish: Atazanavir/ritonavir-armen viste antiviral effekt svarende til lopinavir/ritonavir-armen (non-inferiør) vurderet ved andelen af patienter med HIV-RNA <50 kopier/ml ved uge 48 (tabel 5).
English: For patients who are taking tenofovir disoproxil fumarate,
Danish: Patienter, der tager tenofovirdisoproxilfumarat.
English: In a multiple-dose study in HIV-infected patients dosed with 400 mg of atazanavir once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen.
Danish: I et flerdosis-studie med HIV-inficerede patienter, der fik 400 mg atazanavir én gang dagligt med et let måltid i 12 uger, kunne atazanavir påvises i cerebrospinalvæsken og sæd.
English: The pharmacokinetic data from HIV-infected pregnant women receiving atazanavir capsules with ritonavir are presented in Table 8.
Danish: De farmakokinetiske data fra HIV-smittede gravide kvinder, der fik atazanavir kapsler med ritonavir, er beskrevet i Tabel 8.
English: ≥100,000 copies/ml
Danish: ≥100.000 kopier/ml
English: Patients with coexisting conditions
Danish: Patienter med samtidigt forekommende tilstande
English: 300 mg tenofovir disoproxil fumarate is equivalent to 245 mg tenofovir disoproxil.
Danish: 300 mg tenofovirdisoproxilfumarat er ækvivalent med 245 mg tenofovirdisoproxil.
English: HDPE bottle with polypropylene screw cap containing 60 capsules.
Danish: HDPE-flaske med polypropylenskruelåg indeholder 60 kapsler.
English: - The other ingredients are lactose monohydrate (see section 2, ‘Atazanavir Mylan contains lactose'), crospovidone, magnesium stearate.
Danish: Øvrige indholdsstoffer: lactosemonohydrat (se afsnit 2, Atazanavir Mylan indeholder lactose) crospovidon, magnesiumstearat.
English: Co-administration with a high-fat meal did not affect the AUC of atazanavir relative to fasting conditions and the Cmax was within 11% of fasting values.
Danish: Samtidig indtag af fedtrigt måltid påvirkede ikke AUC for atazanavir i forhold til i fastende tilstand, og Cmax lå inden for 11% i forhold til faste-værdierne.
English: In long-term carcinogenicity studies of atazanavir in mice and rats, an increased incidence of benign hepatic adenomas was seen in female mice only.
Danish: Der er i længerevarende studier af karcinogenecitet af atazanavir hos mus og rotter set en øget incidens af benigne hepatiske adenomer hos hunmus.
English: Lactose monohydrate Crospovidone Magnesium stearate
Danish: Lactosemonohydrat Crospovidon Magnesiumstearat
English: When given with atazanavir, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
Danish: Når rifabutin gives sammen med atazanavir, er den anbefalede rifabutindosis 150 mg 3 gange ugentligt på fastsatte dage (for eksempel mandag-onsdag-fredag).
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Ved tegn på forværret leverlidelse hos sådanne patienter skal man overveje at afbryde eller seponere behandlingen.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der får flere slags antiretroviral medicin på samme tid, kan udvikle en knoglesygdom, der kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir disoproxil fumarate, atazanavir concentrations are expected to be additionally decreased by about 20%.
Danish: Sammenlignet med atazanavir 300 mg med ritonavir 100 mg uden tenofovirdisoproxilfumarat forventes koncentrationen af atazanavir at falde yderligere med ca. 20%.
English: During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μM) of atazanavir corresponding to 30 fold the free drug concentration at Cmax in humans.
Danish: Den klonede, humane kardielle kaliumkanal, hERG, blev hæmmet med 15% i in vitro-studier ved en koncentration (30 μM) af atazanavir svarende til 30 gange den frie lægemiddelkoncentration ved Cmax hos mennesker.
English: Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing atazanavir and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Danish: Andre markante, kliniske laboratoriemæssige abnormaliteter (grad 3 eller 4) rapporteret hos ≥2% af patienterne, der fik regimer indeholdende atazanavir og én eller flere NRTIer omfattede: forhøjet kreatinkinase (7%), forhøjet alaninaminotransferase/serum-glutamin-pyrudrue transaminase (ALAT/SGPT) (5%), lav neutrofiltælling (5%), forhøjet aspartataminotransferase/serum-glutaminoxalsyretransaminase (ASAT/SGOT) (3%) og forhøjet lipase (3%).
English: Didanosine should be taken at the fasted state 2 hours after atazanavir taken with food.
Danish: Didanosin skal tages fastende, 2 timer efter indtagelse af atazanavir, taget til et måltid.
English: INHALED BETA AGONISTS Salmeterol
Danish: BETA-AGONISTER TIL INHALATION Salmeterol
English: If signs or symptoms of cholelithiasis occur, temporary interruption or discontinuation of treatment may be considered.
Danish: Hvis der opstår tegn eller symptomer på cholelithiasis, kan midlertidig afbrydelse eller seponering af behandlingen overvejes.
English: If you notice any symptoms of infection, please inform your doctor immediately.
Danish: Hvis du bemærker symptomer på infektion, skal du straks kontakte lægen.
English: Adults
Danish: Voksne:
English: When atazanavir/ritonavir is co-administered with either phenytoin or phenobarbital, a dose adjustment of phenytoin or phenobarbital may be required.
Danish: Når atazanavir/ritonavir administreres sammen med phenytoin eller phenobarbital, kan det være nødvendigt at justere dosis af phenytoin eller phenobarbital.
English: Stop taking Atazanavir Mylan and talk to your doctor immediately if you develop a severe rash or a rash with flu-like illness symptoms, blisters, fever, mouth sores, muscle or joint pain, swelling in the face, inflammation of the eye which causes redness (conjunctivitis), painful, warm, or red lumps (nodules).
Danish: Stop straks med at tage Atazanavir Mylan og tal med lægen, hvis du får alvorligt udslæt eller udslæt med influenzalignende symptomer, blærer, feber, forkølelsessår, muskel- eller ledsmerter, hævelse i ansigtet, øjenbetændelse, som forårsager røde øjne (konjunktivitis), smertefulde, varme eller røde knuder.
English: a and at Week 96 (Study 045)
Danish: Tabel 6: Effektresultater ved uge 48a og uge 96 (Studie 045)
English: Once opened: Use within 90 days Date opened:
Danish: Efter åbning: Skal bruges inden for 90 dage Dato åbning:
English: Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Danish: Blandt 1.151 patienter, der fik 400 mg atazanavir én gang dagligt, var 177 patienter samtidig inficeret med kronisk hepatitis B eller C, og blandt 655 patienter, der fik 300 mg atazanavir én gang dagligt med 100 mg ritonavir én gang dagligt, var 97 patienter samtidig inficeret med kronisk hepatitis B eller C. Samtidigt inficerede patienter havde større sandsynlighed for forhøjede levertransaminaser ved baseline end de, der ikke havde kronisk viral hepatitis.
English: The efficacy of atazanavir/ritonavir in combination with tenofovir disoproxil fumarate in treatment-experienced patients has been demonstrated in clinical study 045 and in treatment naive patients in clinical study 138 (see sections 4.8 and 5.1).
Danish: Der er vist effekt af atazanavir/ritonavir i kombination med tenofovirdisoproxilfumarat hos behandlingserfarne patienter i det kliniske studie 045 og hos behandlingsnaive patienter i det kliniske studie 138 (se pkt.
English: b See description of selected adverse reactions for more details.
Danish: b Se beskrivelse af udvalgte bivirkninger.
English: A safe and effective dose in combination with atazanavir has not been established for sildenafil when used to treat pulmonary arterial hypertension.
Danish: Der er ikke fastlagt en sikker og effektiv dosis for sildenafil i kombination med atazanavir til behandling af pulmonal arteriel hypertension.
English: uncommon: hypersensitivity
Danish: ikke almindelig: overfølsomhed
English: Symptoms of gallbladder problems may include pain in the right or middle upper stomach area, nausea, vomiting, fever or yellowing your skin or the white part of your eyes.
Danish: Symptomerne på problemer med galdeblæren kan omfatte smerter i den højre side af maven eller midt i den øverste del af maven, kvalme, opkastning, feber eller gulfarvning af huden eller det hvide i øjnene.
English: If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately.
Danish: Hvis du får tegn eller symptomer på nyresten (smerter i siden, blod i urinen, smerter ved vandladning), skal du straks kontakte lægen.
English: 50 to <100 cells/mm
Danish: 50 to <100 celler/mm3
English: PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving Atazanavir Mylan.
Danish: PDE5-hæmmere ved behandling af erektil dysfunktion: Der bør udvises særlig forsigtighed ved ordinering af PDE5-hæmmere (sildenafil, tadalafil eller vardenafil) til behandling af erektil dysfunktion hos patienter, der får Atazanavir Mylan.
English: Administration of atazanavir with ritonavir with either a light or a high-fat meal decreased the coefficient of variation of AUC and Cmax by approximately 25% compared to the fasting state.
Danish: Administration af atazanavir og ritonavir sammen med et let eller et fedtrigt måltid nedsatte variationskoefficienten for AUC og Cmax med ca. 25% sammenlignet med i fastende tilstand.
English: There are no pharmacokinetic data available for atazanavir with ritonavir in patients with renal insufficiency.
Danish: Der foreligger ingen farmakokinetiske data for atazanavir med ritonavir hos patienter med nyreinsufficiens.
English: Atazanavir is metabolised and eliminated primarily by the liver.
Danish: Atazanavir metaboliseres og udskilles primært via leveren.
English: Geometric mean (CV%)
Danish: Geometrisk gennemsnit (CV%)
English: The dose of Atazanavir Mylan capsules for children is calculated by body weight and is taken once daily with food and 100 mg ritonavir as shown below:
Danish: Dosis af Atazanavir Mylan -kapsler til børn beregnes ud fra barnets vægt og skal tages en gang dagligt sammen med mad og 100 mg ritonavir som vist i tabellen nedenfor:
English: The decrease in AUC, Cmax, and Cmin was not mitigated when an increased dose of atazanavir /ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours.
Danish: Faldet i AUC, Cmax, and Cmin var ikke mindre, når en øget dosis af atazanavir /ritonavir (400/100 mg én gang dagligt) blev forskudt fra omeprazol med 12 timer.
English: Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Danish: To procent af patienterne behandlet med atazanavir oplevede samtidig grad 3-4 ALAT/ASAT og grad 3-4 forhøjelser af total bilirubin.
English: Resistance levels to atazanavir ranged from 3.5- to 29-fold without evidence of phenotypic cross resistance to other PIs.
Danish: Resistensniveauerne over for atazanavir strakte sig fra 3,5 til 29 gange uden tegn på fænotypekrydsresistens over for andre PI'er (proteasehæmmere).
English: Eleven subjects (13%) in the unboosted atazanavir group and 6 (7%) in the atazanavir + ritonavir group, had virologic rebound.
Danish: 11 forsøgspersoner (13%) i gruppen med ikke-boostet atazanavir og 6 forsøgspersoner (7%) i gruppen med atazanavir + ritonavir oplevede virologisk rebound.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occurs many months after initiation of treatment.
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også set; tiden til udbrud er imidlertid mere variabel, og udbrud kan optræde mange måneder efter behandlingsstart (se pkt.
English: The choice of Atazanavir Mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient's treatment history (see sections 4.4 and 5.1).
Danish: Valg af Atazanavir Mylan til behandlingserfarne voksne og pædiatriske patienter bør baseres på en individuel, viral resistenstest og patientens behandlingsanamnese (se pkt.
English: For patients not taking tenofovir, if atazanavir 300 mg/ritonavir 100 mg and H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
Danish: Patienter, der ikke tager tenofovir, hvis atazanavir 300 mg/ritonavir 100 mg og H2receptorantagonister administreres samtidigt, bør en dosis svarende til famotidin 20 mg 2 gange dagligt ikke overskrides.
English: The most frequently reported laboratory abnormality in patients receiving regimens containing atazanavir and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect [unconjugated] bilirubin (87% Grade 1, 2, 3, or 4).
Danish: Den oftest rapporterede laboratoriemæssige anormalitet hos patienter, der fik regimer indeholdende atazanavir og én eller flere NRTIer, var forhøjet total bilirubin, primært indberettet som indirekte forhøjet [ukonjugeret] bilirubin (87% grad 1, 2, 3 eller 4).
English: If indicated, elimination of unabsorbed atazanavir should be achieved by emesis or gastric lavage.
Danish: Hvis indiceret, kan udskillelse af uoptaget atazanavir opnås ved opkastning eller maveskylning.
English: The increase in progestin exposure may lead to related side-effects (e.g. insulin resistance, dyslipidemia, acne and spotting), thus possibly affecting the compliance.
Danish: Den øgede progesteron-eksponering kan medføre relaterede bivirkninger (f.eks. insulinresistens, dyslipidæmi, akne og pletblødning), hvorved compliance muligvis påvirkes.
English: There are no dosing recommendations for Atazanavir Mylan in patients less than 3 months of age.
Danish: Der er ingen doseringsanbefalinger for Atazanavir Mylan til børn under 3 måneder.
English: No subject in either group showed emergence of protease inhibitor resistance.
Danish: Ingen forsøgspersoner i de 2 grupper udviklede proteasehæmmer-resistens.
English: Ritonavir capsules, tablets or oral solution.
Danish: 100 mg a Ritonavirkapsler, tabletter eller oral opløsning.
English: Subjects with at least one functional CYP2C19 allele.
Danish: Personer med mindst én funktionel CYP2C19-allel.
English: Atazanavir Mylan is not a cure for HIV infection.
Danish: Atazanavir Mylan er ikke en kur mod HIV-infektion.
English: uncommon: weight decreased, weight gain, anorexia, appetite increased
Danish: ikke almindelig: vægttab, vægtstigning, anoreksi, øget appetit
English: Do not take sildenafil with Atazanavir Mylan when sildenafil is used for the treatment of pulmonary arterial hypertension.
Danish: Du må ikke tage sildenafil sammen med Atazanavir Mylan, hvis sildenafil anvendes til behandling af pulmonal arteriel hypertension.
English: The risk of myopathy including rhabdomyolysis may also be increased with atorvastatin, which is also metabolised by CYP3A4.
Danish: Risikoen for myopati, inklusive rabdomyolyse, kan også øges med atorvastatin, som også metaboliseres via CYP3A4.
English: For dosing recommendations see section 4.2 and for pharmacokinetic data see section 5.2.
Danish: 4.2 og for farmakokinetiske data, se pkt.
English: Immune reactivation syndrome
Danish: Immunreaktiveringssyndrom
English: Paediatric patients (at least 3 months of age and weight at least 5 kg): Other formulations of this medicine may be available for paediatric patients at least 3 months of age and weighing at least 5 kg (see relevant Summary of Product Characteristics for alternative forms).
Danish: Pædiatriske patienter (mindst 3 måneder og med en legemsvægt på mindst 5 kg): Andre formuleringer kan være tilgængelige til pædiatriske patienter, som er mindst 3 måneder og vejer mindst 5 kg (se relevant produktresume).
English: Ritonavir may decrease plasma levels of phenytoin and/or phenobarbital due to CYP2C9 and
Danish: Ritonavir kan reducere plasmakoncentrationen af phenytoin og/eller phenobarbital på grund af CYP2C9- og CYP2C19-induktion.
English: Co-administration of quetiapine with atazanavir is contraindicated as atazanavir may increase quetiapine-related toxicity.
Danish: Samtidig administration af quetiapin og atazanavir er kontraindiceret, da atazanavir kan øge quetiapin-relateret toksicitet.
English: Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by atazanavir.
Danish: Quinidin har et snævert terapeutisk indeks og er kontraindiceret pga. risiko for CYP3A-hæmning med atazanavir.
English: HDPE bottle with polypropylene screw cap containing 30, 90 capsules.
Danish: HDPE-flaske med polypropylenskruelåg indeholder 30, 90 kapsler.
English: Patients should be informed that dizziness has been reported during treatment with regimens containing atazanavir (see section 4.8).
Danish: Patienterne bør informeres om, at der er indberettet svimmelhed ved behandling med regimer indeholdende atazanavir (se pkt.
English: Indinavir is also associated with indirect (unconjugated) hyperbilirubinaemia due to inhibition of UGT.
Danish: Indinavir er ligeledes forbundet med indirekte (ukonjugeret) hyperbilirubinæmi relateret til hæmning af UGT.
English: This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
Danish: Hvis det vurderes nødvendigt, bør samtidig administration kun ske efter individuel vurdering hos patienter med supprimeret HIVvirusbelastning og med HIVvirusstamme uden mistænkt resistens over for HIVbehandlingen.
English: Combination of the PDE5 inhibitor sildenafil when used for the treatment of pulmonary arterial hypertension (PAH) only (see section 4.5).
Danish: Kombination med PDE5-hæmmeren sildenafil udelukkende ved behandling af pulmonal arteriel hypertension (PAH) (se pkt.