natgillin/translations-raw huggingface dataset:
For dosisanbefalinger til børn se produktresuméet for Darunavir Krka 600 mg tabletter.
For dosage recommendations in children see the Summary of Product Characteristics for Darunavir Krka 600 mg tablets.The dose of cobicistat to be used with darunavir has not been established in this patient population.
De farmakokinetiske egenskaber af darunavir i kombination med ritonavir to gange daglig hos 14 behandlingserfarne pædiatriske patienter i alderen 3 til <6 år med en legemsvægt på >15 kg til <20 kg viste, at vægtbaseret dosering resulterede i en darunavireksponering, der var sammenlignelig med eksponeringen hos voksne, der fik darunavir/ritonavir 600/100 mg to gange daglig (se pkt.
The pharmacokinetics of darunavir in combination with ritonavir taken twice daily in 14 treatmentexperienced paediatric patients, aged 3 to < 6 years and weighing at least 15 kg to < 20 kg, showed that weight-based dosages resulted in darunavir exposure that was comparable to that achieved in adults receiving darunavir /ritonavir 600/100 mg twice daily (see section 4.2).
Synsforstyrrelser
IMMUNOSUPPRESSANTS
Hvis der er behov for administration af rosuvastatin og darunavir administreret sammen med darunavir/ritonavir med lavdosis ritonavir, anbefales det at starte med den lavest mulige dosis af rosuvastatin og optitrere til den ønskede kliniske effekt samtidig med overvågning af sikkerheden.
When administration of rosuvastatin and darunavir co-administered with low dose ritonavir is required, it is recommended to start with the lowest possible dose of rosuvastatin and titrate up to the desired clinical effect while monitoring for safety.
Triazolam eller midazolam (indtaget gennem munden)
Triazolam and oral (taken by mouth) midazolam to help you sleep and/or relieve anxiety
Ved symptomer på alvorlige hudreaktioner skal darunavir straks seponeres.
Darunavir should be discontinued immediately if signs or symptoms of severe skin reactions develop.
Boostet darunavir forventes at øge plasmakoncentrationen af dette antipsykotikum.
Boosted darunavir is expected to increase these antipsychotic plasma concentrations.
Hvis antidepressiva coadministreres med boostet darunavir, anbefales dosistitrering af det antidepressive lægemiddel
If antidepressants are co-administered with boosted darunavir, the recommended approach is a dose titration of the antidepressant based on a clinical assessment of antidepressant response.
Voriconazol må kun tages efter en medicinsk udredning - Rifabutin (mod bakterieinfektioner) - Sildenafil, vardenafil, tadalafil (mod impotens eller for højt blodtryk i lungekredsløbet) - Amitriptylin, desipramin, imipramin, nortriptylin, paroxetin, sertralin, trazodon (til behandling af depression og angst) - Maraviroc (til hiv-infektion) - Methadon (til behandling af opioidafhængighed) - Carbamazepin, clonazepam (til forebyggelse af krampeanfald eller til behandling af visse typer nervesmerter) - Colchicin (til behandling af urinsur gigt eller familiær middelhavsfeber) - Bosentan (til behandling af for højt blodtryk i lungekredsløbet) - Buspiron, clorazepat, diazepam, estazolam, flurazepam, midazolam, når det tages som injektion, zoldipem (beroligende midler) - Perphenazin, risperidon, thioridazin (til behandling af psykiske lidelser).
These active substances include e.g.: alfuzosin amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine astemizole, terfenadine colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) elbasvir/grazoprevir cisapride dapoxetine domperidone naloxegol lurasidone, pimozide, quetiapine, sertindole (see section 4.5) triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5) sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil simvastatin, lovastatin and lomitapide (see section 4.5) dabigatran, ticagrelor (see section 4.5).
- Glecaprevir/pibrentasvir, simeprevir (til behandling af hepatitis C-infektion).
Glecaprevir/pibrentasvir,simeprevir (to treat hepatitis C infection) Fentanyl, oxycodone, tramadol(to treat pain)
Darunavir: sammenligning af darunavir/ritonavir 400/100 mg to gange daglig vs darunavir/ritonavir 400/100 mg i kombination med saquinavir 1.000 mg to gange daglig.
daily vs. saquinavir/darunavir/ritonavir 1,000/400/100 mg twice daily Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with saquinavir 1,000 mg twice daily.
Udslæt
Dapoxetine
Darunavir Krka eller 1 tablet a 800 mg Darunavir Krka) sammen med 100 mg ritonavir en gang dagligt.
In the evening, take one 600 milligram Darunavir Krka tablet together with 100 milligram ritonavir.
Lidocain (systemisk)
Disopyramide Flecainide Lidocaine (systemic) Mexiletine Propafenone
- Salmeterol (medicin til behandling af astma).
concentrations of salmeterol.
Darunavir forventes at øge plasmakoncentrationen af disse betablokkere.
Darunavir is expected to increase these β-blocker plasma concentrations.
rifabutin Cmax darunavir AUC ↑ 53% darunavir Cmin ↑ 68% darunavir Cmax ↑ 39% totalt aktivt rifabutin (moderstof + 25-Odesacetylmetabolit)
rifabutin Cmax darunavir AUC ↑ 53% darunavir Cmin ↑ 68% darunavir Cmax ↑ 39% sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite) The interaction trial showed a comparable daily systemic exposure for rifabutin between treatment at 300 mg once daily alone and 150 mg once every other day in combination with darunavir/ritonavir (600/100 mg twice daily) with an about 10fold increase in the daily exposure to the active metabolite 25-O-desacetylrifabutin.
Boostet darunavir forventes at øge plasmakoncentrationen af disse betablokkere.
Boosted darunavir is expected to increase these β-blocker plasma concentrations.
til 17 år henvises til produktresuméet for Darunavir Krka 400 mg og 800 mg tabletter.
For clinical trial results in ART-naïve paediatric patients aged 12 to 17 years, refer to the Summary of Product Characteristics for Darunavir Krka 400 mg and 800 mg tablets.
(lægemiddel)overfølsomhed ikke almindelig
(drug) hypersensitivity uncommon immune reconstitution inflammatory syndrome
Darunavir Krka 600 mg tabletter kan anvendes til at sammensætte passende behandlingsregimer (se pkt.
Darunavir Krka 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
6 celler/l, kan der administreres darunavir 800 mg en gang dagligt med ritonavir 100 mg en gang dagligt med føde.
6/l (see section 4.1) a regimen of 800 mg once daily with ritonavir 100 mg once daily taken with food may be used.
Darunavir Krka 800 mg filmovertrukne tabletter er tilgængelige i beholdere indeholdende 30 filmovertrukne tabletter (1 beholder med 30 filmovertrukne tabletter) og 90 filmovertrukne tabletter (3 beholdere med 30 filmovertrukne tabletter) i en æske.
bottle of 30 film-coated tablets) and 90 film-coated tablets (3 bottles of 30 film-coated tablets) in a box.
Colchicin sammen med boostet darunavir er kontraindiceret til patienter med nedsat nyre- eller leverfunktion (se pkt.
For patients with renal or hepatic impairment colchicine with boosted darunavir is contraindicated (see sections 4.3 and 4.4).
gange atorvastatin Cmax↑ ≈2 gange darunavir/ritonavir atorvastatin AUC ↑ 290 % atorvastatin Cmax ↑ 319 % atorvastatin Cmin ND med darunavir/cobicistat 800/150 mg
Atorvastatin 10 mg once daily atorvastatin AUC ↑ 3-4 fold atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin Cmax ↑ ≈2 fold darunavir/ritonavir atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
Alle patienter 45%
All patients
Asteni, træthed
Renal impairment
Graviditet og post partum Eksponeringen for total-darunavir og ritonavir efter indtagelse af darunavir/ritonavir
If efavirenz is to be used in combination with darunavir /ritonavir, the darunavir/ritonavir
Darunavir forventes at øge plasmakoncentrationen af disse antineoplastika.
Darunavir is expected to increase these antineoplastic plasma
hiv-1-RNA <50 kopier/ml Alle patienter Med hiv-RNA <100.000 ved baseline Med hiv-RNA
HIV-1 RNA < 50 copies/ml All patients
Co-administration af parenteral midazolam med boostet darunavir kan give en kraftig forøgelse af koncentrationen af
If parenteral midazolam is co-administered with boosted darunavir it may cause a large increase in the concentration of this benzodiazepine.
- Dasatinib, everolimus, irinotecan, nilotinib, vinblastin, vincristin (til behandling af kræft).
Itraconazole, isavuconazole, fluconazole,posaconazole, clotrimazole (to treat fungal infections).
6/l) ved baseline
6/l (see section
Koncentrat til injektionsvæske, opløsning
Concentrate for solution for injection
Tag ikke dobbeltdosis for at kompensere for en glemt dosis.
Do not take a double dose to make up for a forgotten dose.
Blod i sæd og/eller urin.
presence of blood in semen and/or urine.
Børn og unge Dette lægemiddel er ikke beregnet til børn og unge under 18 år.
Children and adolescents This medicine is not indicated for use by children and adolescents under the age of 18.
Svær hypotension (< 90/50 mm Hg).
Severe hypotension (< 90/50 mm Hg).
Povindon (K-25)
Povidone (K-25)
De fleste patienter, som disse hændelser blev rapporteret hos, havde allerede eksisterende kardiovaskulære risikofaktorer.
2 Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Visse typer af medicin kan blive påvirket af Talmanco, eller de kan påvirke, hvor godt Talmanco virker.
Some medicines may be affected by Talmanco or they may affect how well Talmanco will work.
Du må ikke tage dette lægemiddel, når du er gravid, medmindre det er absolut nødvendigt, og du har diskuteret det med lægen.
Do not take this medicine when pregnant, unless it is strictly necessary and you have discussed this with your doctor.
Ved terapeutiske koncentrationer er 94% af tadalafil i plasma bundet til proteiner.
At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins.
Overdreven tendens til at svede.
excessive sweating.
Det kan være, at du får nogle af de bivirkninger, som er nævnt i afsnit 4.
You may experience any of the side effects described in section 4.
Hyppighedsestimat: 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 (< 1/10.000) og Ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).
Frequency estimate: 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 (< 1/10,000) and not known (cannot be estimated from the available data).
Hævelser i ansigtet.
swelling of the face.
Hovedpine var den mest almindelige rapporterede bivirkning.
6 Headache was the most commonly reported adverse reaction.
Ældre Dosisjustering hos ældre patienter er ikke nødvendigt.
Elderly Dose adjustments are not required in elderly patients.
Hverken hastigheden eller omfanget af absorptionen af tadalafil påvirkes af fødeindtagelse, så tadalafil kan tages med eller uden mad.
The rate and extent of absorption of tadalafil are not influenced by food, thus tadalafil may be taken with or without food.
Dato for første markedsføringstilladelse: 09 januar 2017
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 January 2017
I studiet fik mere end halvdelen (53,3%) af patienterne samtidig bosentanbehandling.
More than half (53.3%) of the patients in the study were receiving concomitant bosentan therapy.
De fleste af patienterne var klassificeret til World Health Organization (WHO) funktionsklasse III (65,2%) eller II (32,1%).
The majority of patients had a World Health Organization (WHO) Functional Class III (65.2%) or II (32.1%).
Talmanco er til behandling af pulmonal arteriel hypertension hos voksne.
Talmanco is a treatment for pulmonary arterial hypertension in adults.
Der sås signifikant bedring (p<0,01) i 6MWD i 12. uge hvor patienterne blev bedt om at udsætte indtagelsen af studiemedicinen for at afspejle det aktive indholdsstofs dalkoncentration (trough koncentration).
Significant improvement (p < 0.01) in the 6MWD was demonstrated at week 12 when the patients were asked to delay taking study medicinal product in order to reflect trough active substance concentration.
Forbigående hukommelsestab.
passing memory loss.
Hvis du holder op med at tage Talmanco Du må ikke holde op med at tage medicinen, medmindre din læge har rådet dig til det.
If you stop taking Talmanco Do not stop taking your tablets, unless advised otherwise by your doctor.
Disse bivirkninger er ikke set i kliniske studier for pulmonal arteriel hypertension, og hyppigheden er derfor ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is not known (frequency cannot be estimated from the available data):
Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) Priapisme, en forlænget og muligvis smertefuld rejsning efter indtagelse af dette lægemiddel.
Uncommon (may affect up to 1 in 100 people) priapism, a prolonged and possibly painful erection after taking this medicine.
Lavt blodtryk.
low blood pressure.
Gennemsnitsalderen af alle patienterne var 54 år (interval 14 til 90 år) og hovedparten var af kaukasisk oprindelse (80,5%) og kvinder (78,3%).
The mean age of all patients was 54 years (range 14 to 90 years) with the majority of patients being Caucasian (80.5%) and female (78.3%).
Spørg din læge eller apotekspersonalet til råds, før du tager nogen form for medicin, mens du er gravid eller ammer.
Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.
hævelse af øjenlåg, øjensmerter, røde øjne, hjertetilfælde og slagtilfælde.
swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
Filmovertrækning:
Film-coating:
Hvis du på noget tidspunkt tidligere har haft synstab - en tilstand beskrevet som en 'blodprop i øjet' (non-arteritis anterior iskæmisk opticusneuropati - NAION) Hvis du har haft et hjerteanfald inden for de sidste 3 måneder Hvis du har lavt blodtryk
if you have ever had loss of vision - a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION) if you have had a heart attack in the last 3 months if you have low blood pressure if you are taking riociguat.
Tadalafil udskilles overvejende som inaktive metabolitter, for størsteparten i fæces (ca. 61% af dosis) og i mindre grad i urinen (ca. 36% af dosis).
Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose).
Da dette kan være relevant for alle patienter som anvender tadalafil, skal patienten informeres om, at han skal stoppe med at tage tadalafil og omgående skal konsultere en læge, hvis der pludseligt opstår en synsdefekt (se pkt 4.3).
As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking tadalafil and consult a physician immediately (see section 4.3).
Administration Talmanco er til oral brug.
Method of administration Talmanco is for oral use.
Højt blodtryk.
high blood pressure.
Hvis du har glemt at tage Talmanco
If you forget to take Talmanco
Pludselig hjertedød.
sudden cardiac death.
Den samlede hyppighed for ophør med behandling på grund af bivirkninger var lav (tadalafil 11%, placebo 16%).
The overall frequency of discontinuation due to adverse events was low (tadalafil 11%, placebo 16%).
Patienterne skal informeres om ikke at tage tadalafil sammen med disse præparater.
Patients should be informed not to take tadalafil with these medicinal products.
Urticaria5, hyperhidrose (svedsekretion)
Urticaria5, Hyperhydrosis (sweating)
Selvom hyppigheden af rapporter omhandlende svimmelhed var ens i placebo- og tadalafilarmene i de kliniske studier, bør patienterne være opmærksomme på, hvordan de reagerer på tadalafil, før de fører bil eller betjener maskiner.
Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical studies was similar, patients should be aware of how they react to tadalafil, before driving or operating machinery.
Du må ikke amme, mens du tager disse tabletter, fordi det er uvist, om medicinen udskilles i mælken hos mennesker.
Do not breast-feed while taking these tablets as it is not known if the medicine passes into human breast milk.
Hver filmovertrukken tablet indeholder 237,9 mg lactose (234,5 mg som vandfrit og 3,4 mg som monohydrat..
Each film-coated tablet contains 237.9 mg lactose (234.5 mg as anhydrous and 3.4 mg as monohydrate).
28 filmovertrukne tabletter 28 x 1 filmovertrukken tablet 56 filmovertrukne tabletter 56 x 1 filmovertrukken tablet
28 film-coated tablets 28 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets
Tadalafil påvirker kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Tadalafil has negligible influence on the ability to drive or use machines.
Det reproduktive system og mammae Øget uterin blødning4
Reproductive system and breast disorders Increased uterine bleeding4
Aktuelle MedDRA-termer inkluderer abdominalt ubehag, abdominale smerter, nedre abdominale smerter, øvre abdominale smerter og maveubehag.
3 Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower,
Brug af Talmanco sammen alkohol
Talmanco with alcohol
INFORMATION I BRAILLESKRIFT Talmanco 20 mg
INFORMATION IN BRAILLE Talmanco 20 mg
Ætiologien af pulmonal arteriel hypertension var overvejende idiopatisk PAH (61,0%) og relateret til vaskulær bindevævssygdom (23,5%).
Pulmonary arterial hypertension (PAH) etiologies were predominantly idiopathic PAH (61.0%) and related to collagen vascular disease (23.5%).
Hos hæmodialysepatienter var Cmax 41% højere end hos raske forsøgspersoner.
In haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects.
Ved indtagelse af tadalafil 20 mg og 40 mg en gang daglig opnås steady-state plasmakoncentration i løbet af 5 dage, og eksponeringen er ca. 1,5 gange så stor som efter en enkelt dosis.
During tadalafil 20 mg and 40 mg once daily dosing, steady-state plasma concentrations are attained within 5 days, and exposure is approximately 1.5-fold of that after a single dose.
Rapporter vedrørende ændringer i farvesynet var sjældne (< 0,1%) på tværs af alle studier.
Across all clinical studies, reports of changes in colour vision were rare (< 0.1%).
Talmanco er indiceret til behandling af voksne med pulmonal arteriel hypertension (PAH) klassificeret som WHO's funktionsklasse II og III, til forbedring af det fysiske funktionsniveau (se pkt.
Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).
Det kan ikke udelukkes, at der kan være en risiko for det ammede barn.
A risk to the breast-fed child cannot be excluded.
Hvis du tager nogen form for nitrater såsom amylnitrit, som bruges til behandling af brystsmerter (angina pectoris).
if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain.
Hos patienter med PAH, der ikke samtidig fik bosentan, var den gennemsnitlige tadalafileksponering ved steady-state efter indtagelse af 40 mg 26% højere sammenlignet med raske frivillige.
In patients with pulmonary hypertension not receiving concomitant bosentan, the average tadalafil exposure at steady-state following 40 mg was 26% higher when compared to those of healthy volunteers.
Hvis du har taget eller har planer om at tage Talmanco, skal du undgå overdreven alkoholindtagelse (over 5 genstande alkohol).
If you have taken or are planning to take Talmanco, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.
Yderligere oplysninger om dette lægemiddelA findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Patienter med klinisk signifikant aorta- og mitralklapsygdom Patienter med perikardial konstriktion Patienter med restriktiv eller dilateret kardiomyopati Patienter med betydelig venstre ventrikel dysfunktion Patienter med livstruende arytmier Patienter med symptomatisk koronararteriesygdom Patienter med ukontrolleret hypertension.
Patients with clinically significant aortic and mitral valve disease Patients with pericardial constriction Patients with restrictive or congestive cardiomyopathy Patients with significant left ventricular dysfunction Patients with life-threatening arrhythmias Patients with symptomatic coronary artery disease Patients with uncontrolled hypertension.
PVC/PE/PVdC-Alu blisterkort i en pakning indeholdende 28 og 56 filmovertrukne tabletter.
PVC/PE/PVdC-Alu blisters in carton containing 28 and 56 film-coated tablets.
I det pivotale placebo-kontrollerede studie med tadalafil til behandling af PAH blev i alt 323 patienter behandlet med tadalafil i daglige doser fra 2,5 mg til 40 mg, og 82 patienter blev behandlet med placebo.
In the pivotal placebo-controlled study of tadalafil for the treatment of PAH, a total of 323 patients were treated with tadalafil at doses ranging from 2.5 mg to 40 mg once daily and 82 patients were treated with placebo.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med tadalafil i en eller flere undergrupper af den pædiatriske population ved behandling af pulmonal arteriel hypertension (PAH) (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with tadalafil in one or more subsets of the paediatric population in the treatment of pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Disse bivirkninger er enten angivet med frekvensen 'ikke kendt', da frekvensen hos PAH-patienter ikke kan estimeres ud fra de forhåndenværende data, eller angivet med en frekvens baseret på data fra det pivotale kliniske placebo-kontrollerede studie med tadalafil.
These events have either been assigned a frequency of “Not known,” as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical study data from the pivotal placebo-controlled study of tadalafil.
Lactosemonohydrat Hypromellose (2910/15 mPa·s) (E464) Titandioxid (E171)
Hypromellose (2910/15 mPa·s) (E464) Titanium dioxide (E171)
Dosering Den anbefalede dosis er 40 mg (2 x 20 mg) en gang daglig taget enten med eller uden mad.
Posology The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food.
Tadalafil bør ikke anvendes under amning.
Tadalafil should not be used during breast-feeding.
Hvis du er allergisk overfor tadalafil eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
Do not take Talmanco: if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
Filmovertrækningen indeholder lactosemonohydrat (se afsnit 2 'Talmanco indeholder lactose'), hypromellose (E464), titandioxid (E171) og triacetin.
The filmcoating contains lactose monohydrate (see section 2 ‘Talmanco contains lactose'), hypromellose (E464), titanium dioxide (E171) and triacetin.