natgillin/translations-raw huggingface dataset:
Nærmere oplysninger findes på indlægssedlen.
VFEND should not be used in patients who are taking any of the following medicines: • Terfenadine, astemizole (used for allergy) • Cisapride (used for stomach problems) • Pimozide (used to treat mental illnesses) • Quinidine (used for irregular heart beat) • Rifampicin (used to treat tuberculosis) • Carbamazepine (used to treat seizures) • Phenobarbital (used for severe insomnia and seizures) • Ergot alkaloids (e. g. ergotamine, dihydroergotamine; used for migraine) • Sirolimus (used in transplant patients) • Efavirenz (used to treat HIV infection) • Ritonavir (used to treat HIV infection) in doses of 400 mg or more twice daily Caution is also needed when VFEND is taken at the same time as other medicines, see the Package Leaflet for full details.
Hvorfor blev VFEND godkendt?
Why has VFEND been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved VFEND er større end risiciene i forbindelse med behandling af alvorlige svampeinfektioner, særligt hos patienter med livstruende infektioner.
The Committee for Medicinal products for Human Use (CHMP) decided that VFEND’ s benefits are greater than its risks for treatment of serious fungal infections, especially in patients with life- threatening infection.
Udvalget anbefalede, at VFEND godkendes til markedsføring.
They recommended that VFEND be given marketing authorisation.
Andre oplysninger om VFEND:
Other information about VFEND:
Europa- Kommissionen udstedte en markedsføringstilladelse for VFEND, der var gyldig i hele EU, til Pfizer Limited den 19. marts 2002.
The European Commission granted a marketing authorisation valid throughout the European Union, for VFEND to Pfizer Limited on 19 March 2002.
Den europæiske offentlige vurderingsrapport (EPAR) kan ses i sin helhed her.
The full EPAR for VFEND is available here.
Dette sammendrag blev senest ajourført i 09- 2006.
This summary was last updated in 09-2006.
EU/ 1/ 02/ 212/ 001 EU/ 1/ 02/ 212/ 002 EU/ 1/ 02/ 212/ 003 EU/ 1/ 02/ 212/ 004 EU/ 1/ 02/ 212/ 005 EU/ 1/ 02/ 212/ 006 EU/ 1/ 02/ 212/ 007 EU/ 1/ 02/ 212/ 008 EU/ 1/ 02/ 212/ 009 EU/ 1/ 02/ 212/ 010 EU/ 1/ 02/ 212/ 011 EU/ 1/ 02/ 212/ 012 EU/ 1/ 02/ 212/ 013 EU/ 1/ 02/ 212/ 014 EU/ 1/ 02/ 212/ 015 EU/ 1/ 02/ 212/ 016 EU/ 1/ 02/ 212/ 017 EU/ 1/ 02/ 212/ 018 EU/ 1/ 02/ 212/ 019 EU/ 1/ 02/ 212/ 020 EU/ 1/ 02/ 212/ 021 EU/ 1/ 02/ 212/ 022 EU/ 1/ 02/ 212/ 023 EU/ 1/ 02/ 212/ 024 EU/ 1/ 02/ 212/ 025
EU Number EU/ 1/ 02/ 212/ 001 EU/ 1/ 02/ 212/ 002 EU/ 1/ 02/ 212/ 003 EU/ 1/ 02/ 212/ 004 EU/ 1/ 02/ 212/ 005 EU/ 1/ 02/ 212/ 006 EU/ 1/ 02/ 212/ 007 EU/ 1/ 02/ 212/ 008 EU/ 1/ 02/ 212/ 009 EU/ 1/ 02/ 212/ 010 EU/ 1/ 02/ 212/ 011 EU/ 1/ 02/ 212/ 012 EU/ 1/ 02/ 212/ 013 EU/ 1/ 02/ 212/ 014 EU/ 1/ 02/ 212/ 015 EU/ 1/ 02/ 212/ 016 EU/ 1/ 02/ 212/ 017 EU/ 1/ 02/ 212/ 018 EU/ 1/ 02/ 212/ 019 EU/ 1/ 02/ 212/ 020 EU/ 1/ 02/ 212/ 021 EU/ 1/ 02/ 212/ 022 EU/ 1/ 02/ 212/ 023 EU/ 1/ 02/ 212/ 024
Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend
Invented name Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend Vfend
50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg
Strength 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg
Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Pulver til infusionsvæske, opløsning
Pharmaceutical form Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Intravenøs anvendelse
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Flaske (HDPE) Flaske (HDPE) Flaske (HDPE) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Blisterpakning (PVC/ aluminium) Flaske (HDPE) Flaske (HDPE) Flaske (HDPE) Hætteglas
Packaging blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu)) bottle (HDPE) bottle (HDPE) bottle (HDPE) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) bottle (HDPE) bottle (HDPE) bottle (HDPE)
-- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 10 mg/ ml
10 mg/ ml
2 10 14 20 28 30 50 56 100 2 30 100 2 10 14 20 28 30 50 56 100 2 30 100 1 hætteglas
1 vial
Pulver til mikstur, suspension
Powder for oral suspension
PRODUKTRESUME
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Hjælpestof: lactosemonohydrat 63, 42 mg Alle hjælpestoffer er anført under pkt.
Excipient: lactose monohydrate 63.42 mg.
Hvide, runde tabletter, med ” Pfizer ” præget på den ene side og ” VOR50 ” på den anden side.
White, round tablet, debossed “ Pfizer” on one side and “ VOR50” on the reverse.
Voriconazol er et bredspektret triazol- antimykotikum, som er indiceret til følgende:
Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated as follows:
Behandling af candidæmi hos non- neutropene patienter.
Treatment of candidemia in non-neutropenic patients.
Behandling af fluconazol- resistente alvorlige invasive Candida- infektioner (herunder C. krusei).
Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
4. 4).
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4).
Vfend findes også som 200 mg filmovertrukne tabletter, 200 mg pulver til infusionsvæske, opløsning og 40 mg/ ml pulver til oral suspension.
VFEND is also available as 200 mg film-coated tablets, 200 mg powder for solution for infusion and 40 mg/ ml powder for oral suspension.
Brug hos voksne Behandling skal initieres med den specifikke startdosis enten som intravenøs eller oral VFEND for at opnå plasmakoncentrationer tæt på steady state på Dag 1.
Use in adults Therapy must be initiated with the specified loading dose regimen of either intravenous or oral VFEND to achieve plasma concentrations on Day 1 that are close to steady state.
5. 2) kan man skifte mellem intravenøs og oral administration, når det er klinisk indiceret.
On the basis of the high oral bioavailability (96%; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
2 Detaljeret information om dosisanbefalinger ses i følgende tabel:
2 Detailed information on dosage recommendations is provided in the following table:
Oralt Patienter under 40 kg
Oral Patients less than 40 kg
Initialdosis (i de første 24 timer)
Regimen (first 24 hours)
6 mg/ kg hver 12. time (i de første 24 timer)
(for the first 24 hours)
400 mg hver 12. time (i de første 24 timer)
(for the first 24 hours)
200 mg hver 12. time (i de første 24 timer)
(for the first 24 hours)
4 mg/ kg 2 gange dagligt
4 mg/ kg twice daily
Dosisjustering Hvis patientens respons er utilstrækkeligt, bør vedligeholdelsesdosis for oral administration øges til 300 mg 2 gange dagligt.
Dosage adjustment If patient response is inadequate, the maintenance dose may be increased to 300 mg twice daily for oral administration.
Hvis patienterne ikke kan tåle behandling med disse højere doser, reduceres den orale dosis med 50 mg ad gangen til en vedligeholdelsesdosis på 200 mg 2 gange dagligt (eller 100 mg 2 gange dagligt hos patienter med en legemsvægt under 40 kg).
If patients are unable to tolerate treatment at these higher doses reduce the oral dose by 50 mg steps to the 200 mg twice daily (or 100 mg twice daily for patients less than 40 kg) maintenance dose.
4. 4 og 4. 5.
Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
4. 4 og 4. 5.
Rifabutin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 350 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Efavirenz kan gives sammen med voriconazol, hvis vedligeholdelsesdosis for voriconazol øges til 400 mg hver 12. time, og efavirenz- dosis reduceres med 50%, dvs. til 300 mg 1 gang dagligt.
Efavirenz may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 400 mg every 12 hours and the efavirenz dose is reduced by 50%, i. e. to 300 mg once daily.
4. 4 og 4. 5).
When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5).
Behandlingsvarighed afhænger af patienternes kliniske og mykologiske respons.
Treatment duration depends upon patients’ clinical and mycological response.
5. 2).
Use in the elderly No dose adjustment is necessary for elderly patients (see section 5.2).
Brug hos patienter med nedsat nyrefunktion Farmakokinetikken af oralt indgivet voriconazol er ikke påvirket af nedsat nyrefunktion.
Use in patients with renal impairment The pharmacokinetics of orally administered voriconazole are not affected by renal impairment.
5. 2).
Therefore, no adjustment is necessary for oral dosing for patients with mild to severe renal impairment (see section 5.2).
Voriconazol hæmodialyseres med en clearance på 121 ml/ min.
Voriconazole is haemodialysed with a clearance of 121 ml/ min.
En hæmodialysesession på 4 timer fjerner ikke en tilstrækkelig mængde voriconazol til at berettige en dosisjustering.
A four hour haemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment.
Brug hos patienter med nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med akut leverskade manifesteret ved forhøjede leverfunktionsværdier (ALAT, ASAT), (men fortsat monitorering af leverfunktionsværdierne for yderligere forhøjelser anbefales).
Use in patients with hepatic impairment No dose adjustment is necessary in patients with acute hepatic injury, manifested by elevated liver function tests (ALAT, ASAT) (but continued monitoring of liver function tests for further elevations is recommended).
5. 2).
3 It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving VFEND (see section 5.2).
VFEND er ikke undersøgt hos patienter med svær kronisk levercirrose (Child- Pugh klasse C).
VFEND has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).
VFEND har været forbundet med forhøjede levertal og kliniske tegn på leverskade, såsom gulsot og må kun anvendes til patienter med svær leverinsufficiens, hvis fordelen opvejer den potentielle risiko.
VFEND has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and must only be used in patients with severe hepatic impairment if the benefit outweighs the potential risk.
4. 8).
Patients with hepatic impairment must be carefully monitored for drug toxicity (see also section 4.8).
4. 8 og 5. 1).
Use in children VFEND is not recommended for use in children below 2 years due to insufficient data on safety and efficacy (see also sections 4.8 and 5.1).
Den anbefalede vedligeholdelsesdosis hos pædiatriske patienter i alderen 2 til < 12 år er følgende:
The recommended maintenance dosing regimen in paediatric patients 2 to < 12 years is as follows:
Intravenøst *
Intravenous*
Oralt **
Oral**
Initialdosis
Loading Dose Regimen
Oral eller intravenøs initialdosis kan ikke anbefales
No oral or intravenous loading dose is recommended
Vedligeholdelsesdosis
Maintenance Dose
7 mg/ kg 2 gange dagligt
7 mg/ kg twice daily
* Baseret på en farmakokinetisk populationsanalyse hos 82 immunkompromitterede patienter i aldersgruppen 2 til < 12 år ** Baseret på en farmakokinetisk populationsanalyse hos 47 immunkompromitterede patienter i aldersgruppen 2 til < 12 år
*Based on a population pharmacokinetic analysis in 82 immunocompromised patients aged 2 to < 12 years **Based on a population pharmacokinetic analysis in 47 immunocompromised patients aged 2 to < 12 years
5. 2).
Use in paediatric patients aged 2 to < 12 years with hepatic or renal insufficiency has not been studied (see section 4.8 and section 5.2).
Disse anbefalede børnedoseringer er baseret på studier, hvor VFEND blev givet som pulver til oral suspension.
These paediatric dose recommendations are based on studies in which VFEND was administered as the powder for oral suspension.
Tages den formodede, begrænsede gastroenteriske- transittid hos børn i betragtning, kan tablettens absorption være forskellig hos børn sammenlignet med voksne.
Considering the assumed limited gastro-enteric transit time in paediatrics, the absorption of tablets may be different in paediatric compared to adult patients.
Derfor anbefales det at bruge den orale suspension til børn i alderen 2 til < 12.
It is therefore recommended to use the oral suspension formulation in children aged 2- < 12.
Samme dosis som for voksne.
Adolescents (12 to 16 years of age): should be dosed as adults.
4. 5).
Coadministration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine with VFEND is contraindicated since increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes (see section 4.5).
4. 5).
Coadministration of VFEND with rifampicin, carbamazepine and phenobarbital is contraindicated since these medicinal products are likely to decrease plasma voriconazole concentrations significantly (see section 4.5).
VFEND er kontraindiceret ved samtidig administration af højdosis ritonavir (400 mg og derover 2 gange dagligt), da ritonavir ved denne dosis reducerer plasmakoncentrationer af voriconazol signifikant hos raske forsøgspersoner (se pkt.
Coadministration of VFEND with high dose ritonavir (400 mg and above twice daily) is contraindicated because ritonavir significantly decreases plasma voriconazole concentrations in healthy subjects at this dose.
4. 4).
(see section 4.5, for lower doses see section 4.4).
4. 5).
4 Coadministration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, is contraindicated since increased plasma concentrations of these medicinal products can lead to ergotism (see section 4.5).
4. 5).
Coadministration of voriconazole and sirolimus is contraindicated, since voriconazole is likely to increase plasma concentrations of sirolimus significantly (see section 4.5).
4. 5).
The concomitant use of voriconazole with St John’ s Wort is contraindicated (see section 4.5).
4. 8).
Caution should be used in prescribing VFEND to patients with hypersensitivity to other azoles (see also section 4.8).
Nogle azoler, herunder voriconazol, er forbundet med forlængelse af QT- intervallet.
Some azoles, including voriconazole have been associated with QT interval prolongation.
Hos patienter med risikofaktorer, som f. eks. kardiotoksisk kemoterapi i anamnesen, kardiomyopati, hypokaliæmi og samtidig medicin, der kan have været medvirkende årsag, er der set sjældne tilfælde af torsades de pointes, hvis de er i behandling med voriconazol.
Voriconazole should be administered with caution to patients with potentially proarrhythmic conditions, such as
4. 2).
 Congenital or acquired QT-prolongation  Cardiomyopathy, in particular when heart failure is present  Sinus bradycardia  Existing symptomatic arrhythmias  Concomitant medication that is known to prolong QT interval Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.2).
Der er udført et klinisk studie hos raske frivillige forsøgspersoner, hvor effekten af voriconazolbehandling med enkeltdoser op til 4 gange den sædvanlige daglige dosis blev undersøgt på QT- intervallet.
A study has been conducted in healthy volunteers which examined the effect on QT interval of single doses of voriconazole up to 4 times the usual daily dose.
5. 1).
No subject experienced an interval exceeding the potentially clinically relevant threshold of 500 msec (see section 5.1).
Der har i kliniske studier været sjældne tilfælde af alvorlige hepatiske reaktioner under behandling med VFEND (herunder klinisk hepatitis, cholestasis og fulminant leversvigt, som førte til dødsfald).
In clinical trials, there have been uncommon cases of serious hepatic reactions during treatment with VFEND (including clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities).
Forbigående hepatiske reaktioner, herunder hepatitis og gulsot, er set blandt patienter uden andre erkendte risikofaktorer.
Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly haematological malignancy). Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
4. 8).
Liver dysfunction has usually been reversible on discontinuation of therapy (see section 4.8).
Monitorering af leverfunktionen:
Monitoring of hepatic function:
Patienter, der i begyndelsen eller i løbet af behandlingen med voriconazol udvikler abnorme leverfunktionsværdier, skal rutinemæssigt monitoreres for udvikling af mere alvorlig leverskade.
Patients at the beginning of therapy with voriconazole and patients who develop abnormal liver function tests during VFEND therapy must be routinely monitored for the development of more severe hepatic injury.
Patientbehandlingen bør omfatte vurdering af leverfunktionen (især leverfunktionstest og bilirubin).
Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin).
Hvis der udvikles kliniske tegn og symptomer på leversygdom, bør afbrydelse af VFEND- behandling overvejes.
Discontinuation of VFEND should be considered if clinical signs and symptoms are consistent with liver disease development.
Synsrelaterede bivirkninger:
Visual adverse events:
4. 8).
There have been reports of prolonged visual adverse events, including blurred vision, optic neuritis and papilloedema (see Section 4.8).
Nyrerelaterede bivirkninger:
Renal adverse events:
4. 8).
Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medications and have concurrent conditions that may result in decreased renal function (see section 4.8).
Monitorering af nyrefunktionen:
5 Monitoring of renal function:
5 Monitorering af pancreasfunktionen:
Monitoring of pancreatic function:
Patienter, især børn med risikofaktorer for akut pancreatitis (f. eks. nylig kemoterapi, hæmatopoietisk stamcelletransplantation (HSCT)) bør monitoreres tæt under Vfend- behandling.
Patients, especially children, with risk factors for acute pancreatitis (e. g. recent chemotherapy, hematopoietic stem cell translplantation (HSCT)), should be monitored closely during Vfend treatment.
Kontrol af serumamylase eller - lipase bør overvejes under disse forhold.
Monitoring of serum amylase or lipase may be considered in this clinical situation.
Dermatologiske reaktioner:
Dermatological reactions:
Patienter i behandling med VFEND har i sjældne tilfælde udviklet eksfoliative kutanreaktioner, såsom Stevens- Johnsons syndrom.
Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson syndrome, during treatment with VFEND.
Hvis patienter udvikler udslæt, bør de monitoreres nøje, og VFEND afbrydes, hvis læsionen progredierer.
If patients develop a rash they should be monitored closely and VFEND discontinued if lesions progress.
Derudover har VFEND været forbundet med lysfølsom hudreaktion især efter langtidsbehandling.
In addition VFEND has been associated with photosensitivity skin reaction especially during long term therapy.
Det anbefales at informere patienten om, at sollys bør undgås under behandlingen.
It is recommended that patients should be informed to avoid sunlight during the treatment.
Brug hos børn:
Paediatric use:
4. 8 og 5. 1).
Safety and effectiveness in paediatric subjects below the age of two years has not been established (see also sections 4.8 and 5.1).
Hos pædiatriske patienter i alderen 2 til < 12 år, med malabsorption og meget lav legemsvægt, for deres alder, kan oral biotilgængelighed være begrænset.
Oral bioavailability may be limited in paediatric patients aged 2- < 12 years with malabsorption and very low body weight for age.
Phenytoin (CYP2C9- substrat og potent CYP450- induktor):
Phenytoin (CYP2C9 substrate and potent CYP450 inducer):
4. 5).
Concomitant use of voriconazole and phenytoin should be avoided unless the benefit outweighs the risk (see section 4.5).
Rifabutin (CYP450- induktor):
Rifabutin (CYP450 inducer):
Omhyggelig monitorering af fuldt blodbillede og bivirkninger til rifabutin (f. eks. uveitis) anbefales, når rifabutin administreres samtidigt med voriconazol.
Careful monitoring of full blood counts and adverse events to rifabutin (e. g. uveitis) is recommended when rifabutin is coadministered with voriconazole.
4. 5).
Concomitant use of voriconazole and rifabutin should be avoided unless the benefit outweighs the risk (see section 4.5).
Methadon (CYP3A4- substrat):
Methadone (CYP3A4 substrate):
Hyppig monitorering af bivirkninger og toksicitet i forbindelse med methadon, herunder QTc- forlængelse, anbefales ved samtidig administration af voriconazol, da methadonniveauer stiger efter samtidig administration af voriconazol.
Frequent monitoring for adverse events and toxicity related to methadone, including QTc prolongation, is recommended when coadministered with voriconazole since methadone levels increased following co-administration of voriconazole.
4. 5).
Dose reduction of methadone may be needed (see section 4.5).
Korttidsvirkende opiater (CYP3A4- substrat):
Short Acting Opiates (CYP3A4 substrate):