natgillin/translations-raw huggingface dataset:
De kliniske data for isavuconazol til behandlingen af mucormycose er begrænsede til et enkelt prospektivt ukontrolleret klinisk studie med 37 patienter med påvist eller sandsynlig mucormycose, der fik isavuconazol i den primære behandling, eller fordi andre antimykotiske behandlinger (fortrinsvis amphotericin B) ikke var egnede.
The clinical data for isavuconazole in the treatment of mucormycosis are limitedto one prospective non-controlled clinical study in 37 patients with proven or probable mucormycosis who received isavuconazole for primary treatment, or because other antifungal treatments (predominantly amphotericin B) were inappropriate.
Kun i sjældne tilfælde krævede forhøjelserne i levertransaminaser seponering af CRESEMBA.
The elevations in liver transaminases rarely required discontinuation of CRESEMBA.
Den justerede behandlingsdifference (voriconazol−isavuconazol) var 4,0% (95% konfidensinterval: -7,9; 15,9).
The adjusted treatment difference (voriconazole−isavuconazole) was 4.0% (95% confidence interval: −7.9; 15.9).
Disse data indikerer, at de koncentrationer af isavuconazol, der er nødvendige for hæmning in vitro, varierer meget mellem slægter/arter inden for ordenen Mucorales, og er generelt højere end de koncentrationer, der er nødvendige for at hæmme Aspergillus-arter.
These data indicate that concentrations of isavuconazole required for inhibition in vitro are very variable between genera/species within the order of Mucorales, and generally higher than concentrations required to inhibit Aspergillus species.
Mycophenolatmofetil (MMF) (UGT-substrat)
Mycophenolate mofetil (MMF) (UGT substrate)
Nedsat følsomhed over for triazol-antimykotika har været forbundet med mutationer i de fungale cyp51A- og cyp51B-gener, der koder for målproteinet lanosterol 14-alpha-demethylase, som er involveret i ergosterols biosyntese.
Reduced susceptibility to triazole antifungal agents has been associated with mutations in the fungal cyp51A and cyp51B genes coding for the target protein lanosterol 14-alpha-demethylase involved in ergosterol biosynthesis.
Den justerede behandlingsdifference (isavuconazol−voriconazol) var -2,7 % (95% konfidensinterval: -12,9; 7,5).
The adjusted treatment difference (isavuconazole−voriconazole) was −2.7% (95 % confidence interval: −12.9; 7.5).
Samtidig anvendelse af CRESEMBA og CYP3A4-substrater, for eksempel de immunsupprimerende midler tacrolimus, sirolimus eller ciclosporin, kan forhøje den systemiske eksponering for disse lægemidler.
Concomitant use of CRESEMBA with CYP3A4 substrates such as the immunosuppressants tacrolimus, sirolimus or ciclosporin may increase the systemic exposure to these medicinal products.
Pulver til koncentrat til infusionsvæske, opløsning Hvidt til gult pulver
Powder for concentrate for solution for infusion White to yellow powder
Behandlingen med Cresemba vil fortsætte så længe, som lægen har sagt, at den skal.
Cresemba treatment will continue for as long as your doctor tells you.
• mucormycose hos patienter, som amphotericin B ikke er egnet til (se pkt.
• mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1)
Administration af isavuconazoniumsulfat til rotter i en dosis på 90 mg/kg/dag (2,3 gange vedligeholdelsesdosis til mennesker [200 mg] baseret på mg/m2/dag) under drægtighed i afvænningsperioden viste øget perinatal mortalitet hos ungerne.
Administration of isavuconazonium sulfate to rats at a dose of 90 mg/kg/day (2.3-fold the human maintenance dose [200 mg] based on mg/m2/day) during pregnancy through the weaning period showed an increased perinatal mortality of the pups.
Når det rekonstituerede koncentrat er yderligere fortyndet, kan den fortyndede opløsning fremstå med fine hvide til gennemsigtige partikler af isavuconazol, der ikke sedimenterer (men fjernes med et rækkefilter).
After the reconstituted concentrate is further diluted, the diluted solution may show fine white-to-translucent particulates of isavuconazole that do not sediment (but will be removed by in-line filtration).
Isavuconazol udviser fungicid-effekter ved at blokere ergosterol-syntesen, som er en vigtig bestanddel af svampecellemembranen, ved at hæmme det cytochrom P 450-afhængige enzym lanosterol 14alpha-demethylase, der er ansvarlig for omdannelsen af lanosterol til ergosterol.
Isavuconazole demonstrates a fungicidal effect by blocking the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450-dependent enzyme lanosterol 14-alpha-demethylase, responsible for the conversion of lanosterol to ergosterol.
De mest almindelige behandlingsrelaterede bivirkninger var forhøjede leverfunktionstest (7,9%), nausea (7,4%), opkastning (5,5%), dyspnø (3,2%), abdominalsmerter (2,7%), diarré (2,7%), reaktioner på injektionsstedet (2,2%), hovedpine (2,0%), hypokaliæmi (1,7%) og udslæt (1,7%).
The most common treatment-related adverse reactions were elevated liver chemistry tests (7.9%), nausea (7.4%), vomiting (5.5%), dyspnoea (3.2%), abdominal pain (2.7%), diarrhoea (2.7%), injection site reaction (2.2%), headache (2.0%), hypokalaemia (1.7%) and rash (1.7%).
Isavuconazol er en mild hæmmer af UGT.
Isavuconazole is a mild inhibitor of UGT.
For doseringsregimenet på 200 mg var forskellen i mindste kvadraters metode (LSM) i forhold til placebo 13,1 ms 2 timer efter dosering [90% CI: 17,1; 9,1 ms].
For the 200 mg dosing regimen, the least squares mean (LSM) difference from placebo was 13.1 ms at 2 hours post dose [90% CI: 17.1, 9.1 ms].
Der er ikke behov for justering af dosis til patienter med mild eller moderat nedsat leverfunktion (Child-Pugh-klasse A og B) (se pkt.
No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B) (see sections 4.4 and 5.2).
Patienter med familiært kort QT-syndrom (se pkt.
Patients with familial short QT syndrome (see section 4.4).
Der skal udvises forsigtighed i forbindelse med ordination af isavuconazol til patienter med overfølsomhed over for andre azoler.
Caution should be used in prescribing isavuconazole to patients with hypersensitivity to other azole antifungal agents.
De koncentrationer af isavuconazol, der er nødvendige for at hæmme Aspergillus-arter og slægter/arter af ordenen Mucorales in vitro, variere meget.
Concentrations of isavuconazole required to inhibit Aspergillus species and genera/species of the order Mucorales in vitro have been very variable.
Der tilrådes derfor til forsigtighed, når CYP2B6-substrater, herunder især lægemidler med et smalt terapeutisk indeks (fx cyclophosphamid), administreres samtidig med CRESEMBA.
Therefore, caution is advised when CYP2B6 substrates, especially medicinal products with a narrow therapeutic index such as cyclophosphamide, are co-administered with CRESEMBA.
Koncentrationerne af isavuconazol kan falde (induktion af CYP3A fra carbamazepin, phenytoin og langtidsvirkende barbiturater såsom phenobarbital).
Isavuconazole concentrations may decrease (CYP3A induction by carbamazepine, phenytoin and long-acting barbiturates such as phenobarbital).
Efter oral administration af CRESEMBA til raske personer absorberes den aktive del, isavuconazol, og når de maksimale plasmakoncentrationer (Cmax) cirka 2-3 timer efter enkelte og flere doser (se Tabel
Following oral administration of CRESEMBA in healthy subjects, the active moiety isavuconazole is absorbed and reaches maximum plasma concentrations (Cmax) approximately 2-3 hours after single and multiple dosing (see Table 3).
De bivirkninger, der oftest første til permanent seponering af behandling med CRESEMBA, var konfusion (0,7%), akut nyreinsufficiens (0,7%), forhøjet blodbilirubin (0,5%), kramper (0,5%), dyspnø (0,5%), epilepsi (0,5%), respirationsinsufficiens (0,5%) og opkastning (0,5%).
The adverse reactions which most often led to permanent discontinuation of CRESEMBA treatment were confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnoea (0.5%), epilepsy (0.5%), respiratory failure (0.5%) and vomiting (0.5%).
En eksisterende intravenøs slange skal skylles med natriumchlorid 9 mg/ml (0,9%) injektionsvæske eller 50 mg/ml (5%) dextroseopløsning.
An existing intravenous line should be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) dextrose solution.
# Se nedenstående afsnit Beskrivelse af udvalgte bivirkninger
# See section Description of selected adverse reactions below
Ritonavir (i doser på >200 mg hver 12. time) (potent CYP3A4/5-induktor)
Ritonavir (at doses >200 mg every 12 hours) (strong CYP3A4/5 inducer)
Kapslerne kan tages med eller uden mad.
Capsules can be taken with or without food.
CRESEMBA er ikke blevet undersøgt hos patienter med stærkt nedsat leverfunktion (Child-Pughklasse C).
CRESEMBA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Metformin (OCT1-, OCT2- og MATE1substrat)
Metformin (OCT1, OCT2 and MATE1 substrate)
CRESEMBA blev administreret intravenøst (svarende til 200 mg isavuconazol) hver 8. time i de første 48 timer efterfulgt af intravenøs eller oral behandling én gang dagligt (svarende til 200 mg isavuconazol).
CRESEMBA was administered intravenously (equivalent to 200 mg isavuconazole) every 8 hours for the first 48 hours, followed by once-daily intravenous or oral treatment (equivalent to 200 mg isavuconazole).
Behandling af invasiv aspergillose
Treatment of invasive aspergillosis
Den rekonstituerede opløsning skal inspiceres visuelt for tegn på partikler og misfarvning.
The reconstituted solution should be inspected visually for particulate matter and discoloration.
Der er ikke behov for justering af dosis til patienter med nedsat nyrefunktion, herunder patienter med nyresygdom i slutstadiet (se pkt.
No dose adjustment is necessary in patients with renal impairment, including patients with end-stage renal disease (see section 5.2).
De kliniske effektdata er meget begrænsede, ofte til en eller to patienter, for individuelle Mucoralesarter (se pkt.
For individual Mucorales species, the clinical efficacy data are very limited, often to one or two patients (see section 5.1).
Lægemidler, der metaboliseres af CYP2B6
Medicinal products metabolised by CYP2B6
Isavuconazol 600 mg (n = 32)
Isavuconazole 600 mg (n = 32)
CRESEMBA er kontraindiceret til patienter med familiært kort QT-syndrom (se pkt.
CRESEMBA is contraindicated in patients with familial short QT syndrome (see section 4.3).
Justering af CRESEMBA-dosis ikke nødvendig; der tilrådes til forsigtighed, da forekomsten af lægemiddelbivirkninger kan stige.
No CRESEMBA dose adjustment necessary; caution is advised as adverse drug reactions may increase.
Systemorgankl asse
System Organ Class
NNRTI-koncentrationerne kan falde (isavuconazols CYP2B6induktion) eller stige.
NNRTI concentrations may decrease (CYP2B6 induction by isavuconazole) or increase.
Der kan være behov for dosejustering af lægemidler, som er P-gp-substrater, især lægemidler med et smalt terapeutisk indeks, for eksempel digoxin, colchicin og dabigatranetexilat, hvis de administreres samtidig med CRESEMBA (se pkt.
Dose adjustment of medicinal products that are P-gp substrates, especially medicinal products with a narrow therapeutic index such as digoxin, colchicine and dabigatran etexilate, may be needed when concomitantly administered with CRESEMBA (see section 4.5).
Koncentrationerne af colchicin kan stige.
Colchicine concentrations may increase.
Isavuconazol er en induktor af CYP2B6.
Isavuconazole is an inducer of CYP2B6.
C] -isavuconazoniumsulfat til mennesker blev der identificeret et antal mindre metabolitter udover den aktive del (isavuconazol) og det inaktive spaltningsprodukt.
C] isavuconazonium sulfate in humans, in addition to the active moiety (isavuconazole) and the inactive cleavage product, a number of minor metabolites were identified.
Koncentrationerne af statinet kan stige.
Statins concentrations may increase.
Isavuconazol påvirkede ikke fertiliteten hos hun- eller hanrotter, der blev behandlet med orale doser på op til 90 mg/kg/dag (2,3 gange den kliniske vedligeholdelsesdosis baseret på sammenligninger med mg/m2/dag).
Isavuconazole did not affect the fertility of male or female rats treated with oral doses up to 90 mg/kg/day (2.3-fold the clinical maintenance dose based on mg/m2/day comparisons).
Koncentrationerne af saquinavir kan falde (som det er set med lopinavir/ritonavir) eller stige (CYP3A4-hæmning).
Saquinavir concentrations may decrease (as observed with lopinavir/ritonavir) or increase (CYP3A4 inhibition).
I et åbent, ukontrolleret studie fik 37 patienter med påvist eller sandsynlig mucormycose isavuconazol i samme doseringsregimen som det, der blev brugt til behandling af invasiv aspergillose.
In an open-label non-controlled study, 37 patients with proven or probable mucormycosis received isavuconazole at the same dose regimen as that used to treat invasive aspergillosis.
Midazolam: Nøje monitorering af kliniske tegn og symptomer anbefales og justering af dosis om nødvendigt.
Midazolam: careful monitoring of clinical signs and symptoms recommended, and dose reduction if required.
Naturlige produkter Koffein (CYP1A2-substrat)
Natural products Caffeine (CYP1A2 substrate)
Anvendelse af CYP2B6-substratet efavirenz sammen med CRESEMBA er kontraindiceret, da efavirenz er en moderat induktor af CYP3A4/5 (se pkt.
The use of the CYP2B6 substrate efavirenz with CRESEMBA is contraindicated because efavirenz is a moderate inducer of CYP3A4/5 (see section 4.3).
Overfølsomhed over for isavuconazol kan medføre bivirkninger, som omfatter: hypotension, respirationsinsufficiens, dyspnø, udbrud i huden, pruritus og udslæt.
Hypersensitivity to isavuconazole may result in adverse reactions that include: hypotension, respiratory failure, dyspnoea, drug eruption, pruritus, and rash.
For den potente CYP3A4-hæmmer lopinavir/ritonavir blev der observeret en fordobling i eksponeringen af isavuconazol.
For the strong CYP3A4 inhibitor lopinavir/ritonavir, a two-fold increase in isavuconazole exposure was observed.
Du vil få denne dosis, indtil din læge siger andet.
You will be given this dose until your doctor tells you otherwise.
Infusionen skal indgives via et infusionssæt med et integreret filter med en mikroporøs membran af polyethersulfon (PES) og en porestørrelse på 0,2 μm til 1,2 μm.
The infusion must be administered via an infusion set with an in-line filter with a microporous membrane made of polyethersulfone (PES) and with a pore size of 0.2 μm to 1.2 μm.
Samtidigt administrerede lægemidler inddelt efter terapeutisk område
Co-administered medicinal product by therapeutic area
Koncentrationerne af de korttidsvirkende opiater kan stige.
Short-acting opiate concentrations may increase.
Der er indberettet forhøjede levertransaminaser fra kliniske studier (se pkt.
Elevated liver transaminases have been reported in clinical studies (see section 4.8).
Ciclosporin, sirolimus, tacrolimus: monitorering af plasmaniveauer og om nødvendigt relevant dosisjustering.
Ciclosporin, sirolimus, tacrolimus: monitoring of plasma levels and appropriate dose adjustment if required.
Isavuconazol:
Isavuconazole:
Justering af dosis er ikke nødvendig til patienter med mild til moderat nedsat leverfunktion.
No dose adjustment is required in patients with mild to moderate hepatic impairment.
Isavuconazol er ikke umiddelbart dialyserbart (se pkt.
Isavuconazole is not readily dialysable (see section 4.2).
Samtidig administration af CRESEMBA og carbamazepin, phenytoin og langtidsvirkende barbiturater, fx phenobarbital, er kontraindiceret.
The concomitant administration of CRESEMBA and carbamazepine, phenytoin and long-acting barbiturates such as phenobarbital is contraindicated.
Cresemba er et svampedræbende lægemiddel, der indeholder det aktive stof isavuconazol.
What Cresemba is Cresemba is an anti-fungal medicine that contains the active substance isavuconazole.
Infusionsvæsken skal administreres via et infusionssæt med et rækkefilter (porestørrelse 0,2 μm til 1,2 μm), der er fremstillet af polyethersulfon (PES).
The solution for infusion must be administered via an infusion set with an in-line filter (pore size 0.2 μm to 1.2 μm) made of polyether sulfone (PES).
Dextrorphan (aktiv metabolit): AUCinf: ↑ 4%
Dextrorphan (active metabolite): AUCinf: ↑ 4%
4.2 og 4.4.
See sections 4.2 and 4.4.
Cresemba indeholder - Aktivt stof: isavuconazol.
What Cresemba contains - The active substance is isavuconazole.
(OCT2-hæmning)
(OCT2 inhibition)
Startdosis i de første to dage (48 timer) Den anbefalede dosis er to kapsler tre gang om dagen (hver 8. time).
Starting dose for the first two days (48 hours) The recommended dose is two capsules three times a day (every 8 hours).
Din læge vil holde øje med, om du får nogen bivirkninger
Your doctor should monitor you for possible side effects
Ændringer i leverfunktion
Changes in your liver function
CYP2B6-substrater
CYP2B6 substrates
Isavuconazol er en hæmmer in vitro af BCRP, og plasmakoncentrationerne af substrater af BCRP kan derfor stige.
Isavuconazole is an inhibitor in vitro of BCRP, and plasma concentrations of substrates of BCRP may therefore be increased.
Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bemærker en eller flere af følgende bivirkninger:
Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Det Europæiske Lægemiddelagentur har udsat kravet om at indsende resultaterne af forsøg med CRESEMBA i et eller flere delsæt af den pædiatriske population med invasiv aspergillose og mucormycose (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with CRESEMBA in one or more subsets of the paediatric population in the treatment of invasive aspergillosis and the treatment of mucormycosis (see section 4.2 for information on paediatric use).
• på anmodning fra Det Europæiske Lægemiddelagentur • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger,
• At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Isavuconazol fjernes ikke ved hæmodialyse.
Isavuconazole is not removed by haemodialysis.
Ethinyløstradiol og norethindron: intet behov for justering af dosis.
Ethinyl oestradiol and norethindrone: no dose adjustment required.
Vinkaalkaloider (vincristin, vinblastin) (P-gp-substrater)
Vinca alkaloids (vincristine, vinblastine) (P-gp substrates)
anvendelse efter rekonstitution og fortynding
IV use after reconsitution and dilution
Dextromethorphan: Justering af dosis ikke nødvendig.
Dextromethorphan: no dose adjustment required.
Substrater af uridin-diphosphat-glucuronosyltransferaser (UGT)
Uridine diphosphate-glucuronosyltransferases (UGT) substrates
- Øvrige indholdsstoffer: mannitol (E 421) og svovlsyre.
- The other ingredients (excipients) are mannitol (E421) and sulfuric acid.
Andre cancermidler (daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantron, topotecan) (BCRP-substrater)
Other anticancer agents (daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan) (BCRP substrates)
Koncentrationerne af cyclophosphamid kan falde.
Cyclophosphamide concentrations may decrease.
Daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantron eller topotecan: nøje monitorering for forekomst af eventuel lægemiddeltoksicitet og om nødvendigt reduktion af dosis.
Daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone or topotecan: careful monitoring for any occurrence of drug toxicity, and dose reduction if required.
Rødbrun kapselyderside mærket ”100” i sort farve og en hvid hætte mærket "C" i sort farve.
Swedish Orange (reddish-brown) capsule body marked with ”100” in black ink and a white cap marked with "C" in black ink.
Methadon (CYP3A4/5-, 2B6- og 2C9substrat)
Methadone (CYP3A4/5, 2B6 and 2C9 substrate)
Samtidig administration af CRESEMBA og lægemidler, som er substrater af OCT2, kan medføre forhøjede plasmakoncentrationer af disse lægemidler.
Co-administration of CRESEMBA with medicinal products which are substrates of OCT2 may result in increased plasma concentrations of these medicinal products.
Cresemba 100 mg hårde kapsler er kapsler med en rødbrun yderside mærket ”100” i sort farve og en hvid hætte mærket "C" i sort farve.
What Cresemba looks like and contents of the pack Cresemba 100 mg hard capsules are capsules with a reddish-brown body marked with “100” in black ink and a white cap marked with “C” in black ink.
CRESEMBA kapsler kan tages med eller uden mad.
CRESEMBA capsules can be taken with or without food.
R-methadon (aktiv opiat-isomer).
S-methadone (inactive opiate isomer)
Isavuconazol
Isavuconazole
Repaglinid (CYP2C8- og OATP1B1substrat)
Repaglinide (CYP2C8 and OATP1B1 substrate)
Du skal tage denne dosis, indtil din læge siger andet.
You will take this dose until your doctor tells you otherwise.
Hos 5 patienter med mucormycose på grund af Rhizomucor spp.
In 5 patients with mucormycosis due to Rhizomucor spp., no favourable responses were observed.
Forhøjede leverfunktionstest omfatter hændelser med forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet alkalisk phosphatase i blodet, forhøjet bilirubin i blodet, forhøjet laktatdehydrogenase i blodet, forhøjet gammaglutamyltransferase, forhøjet leverenzymtal, unormal leverfunktion, hyperbilirubinæmi, unormale leverfunktionstest og forhøjede transaminaser.
Elevated liver chemistry tests includes events of alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, hepatic function abnormal, hyperbilirubinemia, liver function test abnormal, and transaminases increased.
Antitussiva Dextromethorphan (CYP2D6-substrat)
Antitussives Dextromethorphan (CYP2D6 substrate)
Prednisolon (aktiv metabolit): AUCinf: ↑ 8%
Prednisolone (active metabolite): AUCinf: ↑ 8%
Dabigatranetexilat har et smalt terapeutisk indeks og bør monitoreres.
Dabigatran etexilate has a narrow therapeutic index and should be monitored, and dose reduction if required.
Der er indberettet infusionsrelaterede reaktioner under intravenøs administration af isavuconazol, herunder hypotension, dyspnø, svimmelhed, paræstesi, nausea og hovedpine (se pkt.
During intravenous administration of isavuconazole, infusion-related reactions including hypotension, dyspnoea, dizziness, paraesthesia, nausea, and headache were reported (see section 4.8).
Isavuconazol er et substrat af CYP3A4 og CYP3A5 (se pkt.
Isavuconazole is a substrate of CYP3A4 and CYP3A5 (see section 5.2).
Ketoconazol er kontraindiceret (se pkt.
Ketoconazole is contraindicated (see section 4.3).
Colchicin har et smalt terapeutisk indeks og bør monitoreres.
Colchicine has a narrow therapeutic index and should be monitored, dose reduction if required.
• invasiv aspergillose
• invasive aspergillosis
Symptomer, der blev indberettet oftere ved supraterapeutiske doser af CRESEMBA (svarende til isavuconazol 600 mg/dag) end i gruppen, der fik den terapeutiske dosis (svarende til isavuconazol 200 mg/dag), omfattede: hovedpine, svimmelhed, paræstesi, somnolens, opmærksomhedsforstyrrelser, dysgeusi, mundtørhed, diarré, oral hypoæstesi, opkastning, hedestigninger, angst, uro, palpitationer, takykardi, fotofobi og arthralgi i et QT-studie
Symptoms reported more frequently at supratherapeutic doses of CRESEMBA (equivalent to isavuconazole 600 mg/day) evaluated in a QT study than in the therapeutic dose group (equivalent to isavuconazole 200 mg/day dose) included: headache, dizziness, paraesthesia, somnolence, disturbance in attention, dysgeusia, dry mouth, diarrhoea, oral hypoaesthesia, vomiting, hot flush, anxiety, restlessness, palpitations, tachycardia, photophobia and arthralgia
Den anbefalede dosis er et hætteglas én gang om dagen.
The recommended dose is one vial once a day.