natgillin/translations-raw huggingface dataset:
hævelser i ansigt eller lymfekirtler, øgning i antallet af eosinofile celler (en type hvide blodlegemer), påvirkning af lever, nyrer eller lunger] - hjerteanfald, langsom puls, hjertebanken - synsforstyrrelser - kulderystelser, unormal følelse - følelse af forvirring eller desorientering, humørændring, rastløshed - besvimelse, epileptiske anfald, ændring i eller tab af smagsoplevelse - mundsår, opkastning af blod, betændelse i læberne, tørre læber, belagt tunge - snue - beskadigelse af huden, tør hud - stive muskler eller led, ledsmerter med eller uden betændelse - ændringer i visse blodlegemer eller i blodets kemiske sammensætning.
a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung] heart attack, slow heart beating, palpitations visual disturbance chills, feeling abnormal a feeling of confusion or disorientation, altered mood, restlessness fainting, epileptic fits, changes or loss of taste mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue running nose skin lesions, dry skin stiffness of muscles or joints, joint pain with or without inflammation changes in some values of your blood cells or chemistry.
600 mg filmovertrukne tabletter darunavir
600 mg film-coated tablets darunavir
Darunavir/ ritonavir 800/100 mg en gang dagligt N=343
Darunavir/ritonavir 800/100 mg once daily N=343
sammen med 100 mg ritonavir to gange dagligt to gange dagligt.
together with 100 milligram ritonavir twice daily.
Amitriptylin Desipramin Imipramin Nortriptylin Trazodon paroxetin AUC ↓ 39% paroxetin Cmin ↓ 37% paroxetin Cmax ↓ 36% #darunavir AUC ↔ #darunavir Cmin ↔ #darunavir Cmax ↔ sertralin AUC ↓ 49% sertralin Cmin ↓ 49% sertralin Cmax ↓ 44% #darunavir AUC ↔ #darunavir Cmin ↓ 6% #darunavir Cmax ↔
Amitriptyline Desipramine Imipramine Nortriptyline Trazodone paroxetine AUC ↓ 39% paroxetine Cmin ↓ 37% paroxetine Cmax ↓ 36% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔ sertraline AUC ↓ 49% sertraline Cmin ↓ 49% sertraline Cmax ↓ 44% darunavir AUC ↔ darunavir Cmin ↓ 6% darunavir Cmax ↔
Vedrørende yderligere kliniske studieresultater hos ART-naive voksne henvises til produktresumeet for Darunavir Krka d.d.
For clinical trial results in ART-naïve adult patients, refer to the Summary of Product Characteristics for Darunavir Krka d.d.
400 og 800 mg tabletter anvendes kun til at sammensætte en daglig dosis på 800 mg.
400 and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.
Det reproduktive system og mammae ikke almindelig erektil dysfunktion, gynækomasti Almene symptomer og reaktioner på administrationsstedet almindelig asteni, træthed ikke almindelig pyrexi, brystsmerter, perifert ødem, utilpashed, varmefølelse, irritabilitet, smerte sjælden kulderystelse, unormal følelse, tørhed
General disorders and administration site conditions common asthenia, fatigue uncommon pyrexia, chest pain, peripheral oedema, malaise, feeling hot, irritability, pain rare chills, abnormal feeling, xerosis
Atorvastatin 10 mg en gang daglig atorvastatin AUC ↑ 3-4 gange atorvastatin Cmin ↑ ≈ 5,5-10 gange atorvastatin Cmax↑ ≈2 gange
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
400 mg og 800 mg tabletter anvendes kun til at sammensætte en dosis på 800 mg en gang dagligt.
400 milligram and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.
Hiv-1-RNA <50 kopier/ml Med hiv-1-RNA (kopier/ml) ved baseline
HIV-1 RNA < 50 copies/ml mean HIV-1 RNA log change from baseline (log10 copies/ml)
Den samlede farmakokinetiske, forstærkende effekt af ritonavirmedførte en ca. 14fold stigning i den systemiske eksponering for darunavir ved administration af en oral enkeltdosis darunavir på 600 mg i kombination med 100 mg ritonavir to gange daglig (se pkt.
The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg twice daily (see section 4.4).
375 mg Darunavir Krka d.d.
800 milligram Darunavir Krka d.d.
400 mg filmovertrukne tabletter darunavir
400 mg film-coated tablets darunavir
Den sædvanlige dosis af Darunavir Krka d.d.
The usual dose of Darunavir Krka d.d.
+ 50 mg ritonavir to gange dagligt mellem 30 og 40 kg
375 milligram darunavir + 50 milligram ritonavir twice a day between 30 and 40 kilograms
(CYP3A- og/eller P-gp-hæmning)
(CYP3A and/or P-gp inhibition)
DarunavirKrkad.d.
d.d.
Samtidig brug af boostet darunavir og disse antidepressiva kan øge koncentrationerne af antidepressivummet.
Concomitant use of boosted darunavir and these antidepressants may increase
800 mg darunavir/100 mg ritonavir en gang dagligt
800 mg darunavir/100 mg ritonavir once daily
Darunavir/ ritonavir 600/100 mg to gange dagligt N=298
darunavir/ritonavir 600/100 mg twice daily N=298
Rosuvastatin 10 mg en gang daglig rosuvastatin AUC ↑ 48% rosuvastatin Cmax ↑ 144% ║ baseret på offentliggjorte data data med darunavir/ritonavir rosuvastatin AUC ↑ 93 % rosuvastatin Cmax ↑ 277 % rosuvastatin Cmin ND
based on published data with darunavir/ritonavir rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
Patienter, der får Darunavir Krka d.d.
In patients taking Darunavir Krka d.d.
30 filmovertrukne tabletter: EU/1/17/1248/001 60 filmovertrukne tabletter: EU/1/17/1248/002 90 filmovertrukne tabletter: EU/1/17/1248/003 180 filmovertrukne tabletter: EU/1/17/1248/004
30 film-coated tablets: EU/1/17/1248/001 60 film-coated tablets: EU/1/17/1248/002 90 film-coated tablets: EU/1/17/1248/003 180 film-coated tablets: EU/1/17/1248/004
30 filmovertrukne tabletter: EU/1/17/1248/005 60 filmovertrukne tabletter: EU/1/17/1248/006 90 filmovertrukne tabletter: EU/1/17/1248/007 180 filmovertrukne tabletter: EU/1/17/1248/008
30 film-coated tablets: EU/1/17/1248/005 60 film-coated tablets: EU/1/17/1248/006 90 film-coated tablets: EU/1/17/1248/007 180 film-coated tablets: EU/1/17/1248/008
+ 60 mg ritonavir to gange dagligt mere end 40 kg*
450 milligram darunavir + 60 milligram ritonavir twice a day more than 40 kilograms*
Virkning af darunavir 800 mg en gang dagligt co-administreret med 100 mg ritonavir en gang dagligt hos ART-erfarne patienter
Efficacy of darunavir 800 mg once daily co-administered with 150 mg cobicistat once daily in ARTnaïve and ART-experienced patients
Darunavir/ ritonavir 800/100 mg en gang dagligt N=294
darunavir/ritonavir 800/100 mg once daily N=294
EU/1/17/1248/005 30 filmovertrukne tabletter EU/1/17/1248/006 60 filmovertrukne tabletter EU/1/17/1248/007 90 filmovertrukne tabletter EU/1/17/1248/008 180 filmovertrukne tabletter
EU/1/17/1248/005 30 film-coated tablets EU/1/17/1248/006 60 film-coated tablets EU/1/17/1248/007 90 film-coated tablets EU/1/17/1248/008 180 film-coated tablets
EU/1/17/1248/001 30 filmovertrukne tabletter EU/1/17/1248/002 60 filmovertrukne tabletter EU/1/17/1248/003 90 filmovertrukne tabletter EU/1/17/1248/004 180 filmovertrukne tabletter
EU/1/17/1248/001 30 film-coated tablets EU/1/17/1248/002 60 film-coated tablets EU/1/17/1248/003 90 film-coated tablets EU/1/17/1248/004 180 film-coated tablets
I de fleste tilfælde kan Darunavir Krka d.d.
In most cases, Darunavir Krka d.d.
Darunavir/ ritonavir 600/100 mg to gange dagligt N=296
darunavir/ritonavir 600/100 mg twice daily N=296
Hvis der er behov for administration af rosuvastatin og darunavir administreret sammen 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.
Samtidig anvendelse af salmeterol og darunavir co-administreret med lavdosis ritonavir kan øge plasmakoncentrationen af salmeterol.
and darunavir co-administered with low dose ritonavir may increase plasma concentrations of salmeterol.
Darunavir/ritonavir 600/100 mg x 2 + OBR N=298
Darunavir/ritonavir 600/100 mg twice daily + OBR N=298
Se produktresuméet for Darunavir Krka d.d.
See the Summary of Product Characteristics for Darunavir Krka d.d.
100 mg ritonavir en gang dagligt.
together with 100 milligram ritonavir once daily.
- Fentanyl, oxycodon, tramadol (til behandling af smerter).
Perphenazine, risperidone, thioridazine (to treat psychiatric conditions).
Det reproduktive system og mammae ikke almindelig erektil dysfunktion, gynækomasti Almene symptomer og reaktioner på administrationsstedet almindelig
Reproductive system and breast disorders uncommon erectile dysfunction, gynaecomastia
Tag ikke Darunavir Krka d.d.
Do not combine Darunavir Krka d.d.
ubehag i maven, forstoppelse, ræben - nyresvigt, nyresten, besvær med vandladning, hyppig eller overdreven vandladning til tider om natten - nældefeber, alvorlige hævelser i huden eller andre væv (hyppigst læber eller øjne), eksem, meget kraftig svedafsondring, nattesved, hårtab, akne, skællet hud, misfarvning af negle - muskelsmerter, muskelkramper eller -svaghed, smerter i lemmerne,
Uncommon side effects (may affect up to 1 in 100 people) chest pain, changes in electrocardiogram, rapid heart beating decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance difficulty breathing, cough, nosebleed, throat irritation inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis slowing down of the thyroid gland function.
Rifabutin 150 mg hver anden dag rifabutin AUC **↑ 55% rifabutin Cmin ** ↑ ND rifabutin Cmax** darunavir AUC ↑ 53% darunavir Cmin ↑ 68% darunavir Cmax ↑ 39% ** totalt aktivt rifabutin (moderstof + 25-O-desacetylmetabolit)
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.
Du må ikke tage Darunavir Krka d.d.
Do not take Darunavir Krka d.d.
indeholder - Aktivt stof: darunavir.
What Darunavir Krka d.d.contains -The active substance is darunavir.
Sådan skal du tage Darunavir Krka d.d.
How to take Darunavir Krka d.d.
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).
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).
må ikke kombineres med naturlægemidler, der indeholder perikon (Hypericum perforatum).
with products that contain St John's wort (Hypericum perforatum).
Darunavir kan administreres sammen med lavdosis ritonavir og dolutegravir uden dosisjusteringer.
Darunavir co-administered with low dose ritonavir and dolutegravir can be used without dose adjustment.
(2tabletter a 400mg
Elimination After a 400/100 mg
8/2 mg-16/4 mg en gang daglig buprenorphin AUC ↓ 11%
Buprenorphine/naloxone 8/2 mg-16/4 mg once daily buprenorphine AUC ↓ 11% buprenorphine Cmin ↔ buprenorphine Cmax ↓ 8% norbuprenorphine AUC ↑ 46% norbuprenorphine Cmin ↑ 71%
Anbefalet dosis af darunavir tabletter og ritonavir a til behandlingserfarne pædiatriske patienter (3 til 17 år) Legemsvægt (kg) Dosis (en gang dagligt i forbindelse med et måltid)
Recommended dose for treatment-experienced paediatric patients (3 to 17 years) with darunavir tablets and ritonavir
Brug af Darunavir Krka d.d.
Take Darunavir Krka d.d.
- Glecaprevir/pibrentasvir, simeprevir (til behandling af hepatitis C-infektion).
Boceprevir (hepatitis C infection)
samtidig brug af darunavir/cobicistat og potente CYP3A-induktorer er derfor kontraindiceret (se pkt.
Darunavir boosted with cobicistat is more sensitive for CYP3A induction: concomitant use of darunavir/cobicistat and strong CYP3A inducers is therefore contraindicated (see section 4.3),and concomitant use with weak to moderate CYP3A inducers is not recommended (see section 4.5).
tuberkolose) - Saquinavir (til hiv-infektion).
Maraviroc (to treat HIV infection)
Resultater ved uge 48 Behandlingsnaive darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=295
Treatment-naïve darunavir/cobicistat 800/150 mg once daily + OBR N=295
celletal
Posology
- Dasatinib, everolimus, irinotecan, nilotinib, vinblastin, vincristin (til behandling af kræft).
Artemether/lumefantrine (a combination medicineto treat malaria) Dasatinib, everolimus,irinotecan,nilotinib, vinblastine, vincristine (to treat cancer) Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)
Udslæt
↑ ND
virker ikke korrekt uden ritonavir - Om morgenen skal du tage en 600 mg Darunavir Krka d.d.-tablet sammen med 100 mg ritonavir - Om aftenen skal du tage en 600 mg Darunavir Krka d.d.-tablet sammen med 100 mg ritonavir - Tag Darunavir Krka d.d.
In the morning, take one 600 milligram Darunavir Krkad.d.tablettogether with 100 milligram ritonavir.
methylergometrin) - elbasvir/grazoprevir - cisaprid - dapoxetin - domperidon - naloxegol - lurasidon, pimozid, quetiapin, sertindol (se pkt.
alfuzosin amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine astemizole, terfenadine colchicine when used in patients with renal and/or hepatic impairment (see section 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,
Koncentrationen af voriconazol kan øges eller nedsættes ved co
(induction of CYP450 enzymes) Concentrations of voriconazole may increase or decrease when co-administered with darunavir co-administered with cobicistat.
Selvom du har det bedre, må du ikke stoppe med at tage Darunavir Krka d.d..
Even when you feel better, do not stop taking Darunavir Krka d.d.. Talk to your doctor first.
som tabletter.
tablets the child must take.
120 (3x40) kapsler
120 (3x40) capsules
Disse medlemsstater kunne imidlertid ikke nå til enighed, og Det Forenede Kongeriges lægemiddelkontrolmyndighed henviste sagen til CHMP til voldgift den 30. april 2009.
However, the member states were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 30 April 2009.
Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Det Forenede Kongerige) vurderer et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, som gælder både nationalt og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Den Tjekkiske Republik, Tyskland, Polen og Slovakiet).
This is a procedure when one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance the Czech Republic, Germany, Poland and Slovakia).
Spørgsmål og svar vedrørende indbringelsesproceduren for Pantoprazole Olinka pantoprazol 20- og 40-mg tabletter
Questions and answers on the referral for Pantoprazole Olinka pantoprazole 20 and 40 mg tablets
Bioækvivalensundersøgelser anvendes til at sammenligne, hvordan et generisk lægemiddel optages i kroppen i forhold til referencelægemidlet.
Bioequivalnce studies are used to compare how a generic medicine is absorbed by the body in comparison to the reference medicine.
Det Europæiske Lægemiddelagentur har afsluttet en voldgiftsprocedure som følge af uenighed blandt Den Europæiske Unions medlemsstater om godkendelsen af lægemidlet Pantoprazole Olinka.
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Olinka.
Pantoprazole Olinka er et lægemiddel, der anvendes til behandling af sygdomme, hvor der produceres for meget syre i maven.
Pantoprazole Olinka is a medicine used to treat diseases where the stomach produces too much acid.
På basis af en vurdering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at Pantoprazole Olinka havde vist sig at være bioækvivalent med referencelægemidlet, og at der kunne udstedes markedsføringstilladelse i Det Forenede Kongerige og alle de berørte medlemsstater.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Pantoprazole Olinka had been shown to be bioequivalent to the reference medicine, and therefore the marketing authorisation should be granted in the UK and all concerned member states.
Hvad er Pantoprazole Olinka?
What is Pantoprazole Olinka?
Agenturets Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Pantoprazole Olinka opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i EU-medlemsstaterne Den Tjekkiske Republik, Tyskland, Polen og Slovakiet.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Olinka outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the European Union, the Czech Republic, Germany, Poland and Slovakia.
Olinka UK Ltd. indgav en ansøgning for Pantoprazole Olinka til Det Forenede Kongeriges lægemiddelkontrolmyndighed med henblik på en decentral procedure.
Olinka UK Ltd. submitted Pantoprazole Olinka to the United Kingdom medicines regulatory agency for a decentralised procedure.
Pantoprozole Olinka er et generisk lægemiddel, der er baseret på referencelægemidlet Pantecta.
Pantoprozole Olinka is a generic medicine based on the reference medicine Pantecta.
Hvorfor blev Pantoprazole Olinka vurderet igen?
Why was Pantoprazole Olinka reviewed?
Det aktive stof i Pantoprazole Olinka, pantoprazol, er en protonpumpehæmmer.
The active substance in Pantoprazole Olinka, pantoprazole, is a proton pump inhibitor.
Begrundelsen for indbringelsen var, at den tyske lægemiddelkontrolmyndighed havde givet udtryk for betænkeligheder vedrørende den bioækvivalensundersøgelse, hvor Pantoprazole Olinka og Pantecta var blevet sammenlignet.
The grounds for the referral were concerns expressed by the German medicines regulatory agency regarding the bioequivalence study comparing Pantoprazole Olinka and Pantecta.
27. august 2009, 26. oktober 2009
Company responses provided on: 27 August 2009, 26 October 2009 Opinion date:
Pantoprazole Olinka fås som enterotabletter.
Pantoprazole Olinka is presented as gastro-resistant tablets.
Dato for seneste fornyelse: 18. juli 2014.
Date of latest renewal: 18 July 2014
• hvilke dage, der er dine doseringsdage.
- which days are your dosing days.
• hvis du nogensinde har haft eller ved at du kan have hepatitis B infektion.
- if you have ever had or might now have a hepatitis B infection.
Det skyldes, at De ikke må tage Temomedac under graviditet, medmindre det er klart angivet af din læge.
This is because you must not be treated with Temomedac during pregnancy unless clearly indicated by your doctor.
Læs denne indlægsseddel grundigt inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Dosis under serie 2 - 6 ved fravær af toksicitet
Dose during Cycles 2 - 6 in absence of toxicity
TMZ-dosis (mg/m²/dag)
TMZ dose (mg/m²/day)
Temomedac bør ikke anvendes til gravide kvinder.
Temomedac should not be administered to pregnant women.
†Inklusive tilfælde med dødelig udgang * Hyppigheden er estimeret på basis af relevante kliniske undersøgelser
† Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
I nogle tilfælde kan det være nødvendigt at stoppe behandlingen med Temomedac
In some cases, it may be necessary to stop treatment with Temomedac.
Da det ikke kan udelukkes, at ændringen i Cmax er klinisk signifikant, bør Temomedac indgives uden føde.
As it cannot be excluded that the change in Cmax is clinically significant, Temomedac should be administered without food.
Den 6 måneders hændelses-frie overlevelse for ITT populationen var 44 % med en median event-fri overlevelse på 4,6 måneder, hvilket var i lighed med resultaterne for den progressionsfri overlevelse.
The 6 month event-free survival for the ITT population was 44 % with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Når du tager Temomedac, kan du føle dig træt eller søvnig.
Temomedac may make you feel tired or sleepy.
LÆGEMIDDELFORM Hård kapsel (kapsel).
PHARMACEUTICAL FORM Hard capsule (capsule).
Behandling med Temomedac kan give et fald i antallet af visse typer blodceller.
Temomedac treatment can cause a reduction in certain kinds of blood cells.
kapselskal (inklusive tryksværte):
capsule shell (including printing ink):