natgillin/translations-raw huggingface dataset:
19 Nedsat nyrefunktion I et oralt enkeltdosisstudie (200 mg) hos patienter med normal nyrefunktion og mild (kreatinin clearance 41- 60 ml/ min) til svært nedsat nyrefunktion (kreatinin clearance < 20 ml/ min) var voriconazols farmakokinetik ikke signifikant påvirket af nedsat nyrefunktion.
19 Renal impairment In an oral single dose (200 mg) study in subjects with normal renal function and mild (creatinine clearance 41-60 ml/ min) to severe (creatinine clearance < 20 ml/ min) renal impairment, the pharmacokinetics of voriconazole were not significantly affected by renal impairment.
Voriconazols plasmaproteinbinding var den samme hos patienter med forskellige grader af nedsat nyrefunktion.
The plasma protein binding of voriconazole was similar in subjects with different degrees of renal impairment.
4. 2 og 4. 4.
See dosing and monitoring recommendations under sections 4.2 and 4.4.
Nedsat leverfunktion Efter en oral enkeltdosis (200 mg) var AUC 233% højere hos personer med mild til moderat levercirrose (Child- Pugh klasse A og B) sammenlignet med personer med normal leverfunktion.
Hepatic impairment After an oral single dose (200 mg), AUC was 233% higher in subjects with mild to moderate hepatic cirrhosis (Child-Pugh A and B) compared with subjects with normal hepatic function.
I et oralt flerdosisstudie var AUCτ ens for personer med moderat levercirrose (Child- Pugh klasse B), der fik en vedligeholdelsesdosis på 100 mg 2 gange dagligt, og personer med normal leverfunktion, der fik 200 mg 2 gange dagligt.
In an oral multiple dose study, AUCτ was similar in subjects with moderate hepatic cirrhosis (Child- Pugh B) given a maintenance dose of 100 mg twice daily and subjects with normal hepatic function given 200 mg twice daily.
Der er ingen tilgængelige farmakokinetiske data på patienter med alvorlig levercirrose (Child- Pugh klasse C).
No pharmacokinetic data are available for patients with severe hepatic cirrhosis (Child-Pugh C).
5. 3 Præklinisk sikkerhedsdata
5.3 Preclinical safety data
I undersøgelser af den præ - og postnatale udvikling hos rotter, forlængede voriconazol, ved en mindre optagelse end den, der ses ved terapeutiske doser hos mennesker, gestations - og fødselsvarigheden, medførte dystoci med heraf følgende maternal mortalitet, og reducerede den perinatale overlevelse af afkommet.
In the pre and postnatal development study in rats at exposures lower than those obtained in humans with therapeutic doses, voriconazole prolonged the duration of gestation and labour and produced dystocia with consequent maternal mortality and reduced perinatal survival of pups.
Effekten på fødslen er sandsynligvis medieret af artsspecifikke mekanismer, der omfatter fald i østradiolniveuaer, og er konsistent med det, der er observeret ved andre azol- antimykotika.
The effects on parturition are probably mediated by species-specific mechanisms, involving reduction of oestradiol levels, and are consistent with those observed with other azole antifungal agents.
Lactosemonohydrat Pregelatineret stivelse Croscarmellosenatrium Povidon Magnesiumstearat.
Lactose Monohydrate Pregelatinised Starch Croscarmellose Sodium Povidone Magnesium Stearate
Hypromellose Titandioxid (E171) Lactosemonohydrat Glyceroltriacetat.
Hypromellose Titanium Dioxide (E171) Lactose Monohydrate Glycerol Triacetate
20 6. 3 Opbevaringstid
20 6.3 Shelf life
6. 5 Emballage og pakningsstørrelser
6.5 Nature and contents of container
HDPE tabletbeholdere med 2, 30 og 100 tabletter.
HDPE tablet containers of 2, 30 and 100.
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Not all bottle sizes may be marketed.
PVC/ Aluminiumblister i kartoner med 2, 10, 14, 20, 28, 30, 50, 56 og 100 tabletter.
PVC / Aluminium blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 and 100.
21. marts 2002
21 March 2002 Date of last renewal:
6. 1.
Excipient: lactose monohydrate 253.675 mg For a full list of excipients, see section 6.1.
Hvide, kapselformede tabletter, med ” Pfizer ” præget på den ene side og ” VOR200 ” på den anden side.
White, capsule-shaped tablet, debossed “ Pfizer” on one side and “ VOR200” 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:
Vfend findes også som 50 mg filmovertrukne tabletter, 200 mg pulver til infusionsvæske, opløsning og 40 mg/ ml pulver til oral suspension.
VFEND is also available as 50 mg film-coated tablets, 200 mg powder for solution for infusion and 40 mg/ ml powder for oral suspension.
22 Detaljeret information om dosisanbefalinger ses i følgende tabel:
22 Detailed information on dosage recommendations is provided in the following table:
Vedligeholdelsesdosis
Maintenance Dose (after first 24 hours)
mg/ kg 2 gange
4 mg/ kg twice daily
100 mg 2 gange
100 mg twice daily
(efter de første 24 timer) dagligt
Dosage adjustment
Dosisjustering Hvis patientens respons er utilstrækkeligt, bør vedligeholdelsesdosis for oral administration øges til 300 mg 2 gange dagligt.
If patient response is inadequate, the maintenance dose may be increased to 300 mg twice daily for oral administration.
En hæmodialysesession på 4 timer fjerner ikke en tilstrækkelig mængde voriconazol til at berettige en dosisjustering.
A four hour haemodialysis session does not remove sufficient amount of voriconazole to warrant dose adjustement.
5. 2).
23 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).
4. 4).
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 (see section 4.5, for lower doses see section 4.4).
4. 5).
24 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).
Monitorering af nyrefunktionen:
25 Monitoring of renal function:
25 Monitorering af pancreasfunktionen:
Monitoring of pancreatic function:
Kontrol af serumamylase eller – lipase bør overvejes under disse forhold.
Monitoring of serum amylase or lipase may be considered in this clinical situation.
Dosisreduktion af alfentanil og andre korttidsvirkende opiater, der har samme struktur som alfentanil, og som metaboliseres af CYP3A4 (f. eks. fentanyl og sufentanil) bør overvejes ved samtidig administration af voriconazol (se pkt.
Reduction in the dose of alfentanil and other short acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e. g fentanyl and sufentanil) should be considered when co-administered with voriconazole (see section 4.5).
Det kan derfor være nødvendigt med en længere overvågning af respirationen.
As the half-life of alfentanil is prolonged in a four-fold manner in combination with voriconazole, a longer respiratory monitoring period may be necessary).
4. 3).
Coadministration of voriconazole and low dose ritonavir (100mg twice daily) should be avoided unless an assessment of the benefit/ risk justifies the use of voriconazole (see section 4.5, for higher doses see section 4.3).
4. 2 og 4. 5).
When voriconazole is coadministered with efavirenz the dose of voriconazole should be increased to 400 mg every 12 hours and that of efavirenz should be decreased to 300 mg every 24 hours (see sections 4.2 and 4.5).
Dette afsnit omfatter andre lægemidlers virkning på voriconazol, virkninger af voriconazol på andre lægemidler og to- vejs interaktioner.
26 This section addresses the effects of other medicinal products on voriconazole, the effects of voriconazole on other medicinal products and two-way interactions.
Kontraindikationer, interaktioner der kræver dosisjustering og omhyggelig klinisk og/ eller 26 biologisk monitorering, og til sidst dem der ingen signifikant farmakokinetisk interaktion har, men som har klinisk interesse for det terapeutiske område.
The interactions for the first two sections are presented in the following order: contraindications, those requiring dosage adjustment and careful clinical and/ or biological monitoring and finally those that have no significant pharmacokinetic interaction but may be of clinical interest in this therapeutic field.
Andre lægemidlers virkning på voriconazol
Effects of other medicinal products on voriconazole
Voriconazol metaboliseres via cytochrom P450- isoenzymerne CYP2C19, CYP2C9 og CYP3A4.
Voriconazole is metabolised by cytochrome P450 isoenzymes, CYP2C19, CYP2C9 and CYP3A4.
Effekten af samtidig administration af oral voriconazol (200 mg 2 gange dagligt) og højdosis (400 mg) og lavdosis (200 mg) oral ritonavir er undersøgt i 2 separate studier af raske frivillige forsøgspersoner.
The effect of the coadministration of voriconazole (200 mg twice daily) and high dose (400 mg) and low dose (100 mg) oral ritonavir was investigated in two separate studies in healthy volunteers.
Administration af voriconazol har ingen signifikant effekt på middel Cmax og AUCτ af ritonavir i højdosis- studiet, men der ses en lille nedsættelse af steady state Cmax og AUCτ af ritonavir med gennemsnitlig henholdsvis 25% og 13% i lavdosis ritonavir interaktionsstudiet.
Administration of voriconazole did not have a significant effect on mean Cmax and AUCτ of ritonavir in the high dose study although a minor decrease in steady state Cmax and AUCτ of ritonavir with an average of 25% and 13% respectively was observed in the low dose ritonavir interaction study.
I hvert af ritonavir interaktionsstudierne blev en patient (outlier) identificeret, med forhøjet voriconazol- niveau.
One outlier subject with raised voriconazole levels was identified in each of the ritonavir interaction studies.
P- gp- induktor):
St John’ s Wort (CYP450 inducer; P-gp inducer):
27 Voriconazol bør anvendes med forsigtighed hos patienter, der samtidig tager medicin, som er kendt for at forlænge QT- intervallet.
27 Voriconazole should be administered with caution in patients with concomitant medication that is known to prolong QT interval.
4. 3).
When there is also a potential for voriconazole to increase the plasma levels of substances metabolised by CYP3A4 isoenzymes (certain antihistamines, quinidine, cisapride, pimozide) co-administration is contraindicated (see section 4.3).
Steady state administration af oral voriconazol øger AUCτ af en enkeltdosis alfentanil 6 gange.
Short Acting Opiates (CYP3A4 substrate): steady-state administration of oral voriconazole increased the AUCτ of a single dose of alfentanil by 6-fold.
4. 4).
Reduction in the dose of alfentanil and other short acting opiates similar in structure to alfentanil and metabolised by CYP3A4, (e. g. fentanyl and sufentanil) should be considered when coadministered with voriconazole (see section 4.4).
28 Andre orale antikoagulantia, f. eks. phenprocoumon, acenocoumarol (CYP2C9, CYP3A4- substrater):
28 Other oral anticoagulants e. g. phenprocoumon, acenocoumarol (CYP2C9, CYP3A4 substrates):
Vinkaalkaloider (CYP3A4- substrater):
Vinca Alkaloids (CYP3A4 substrates):
4. 2.
Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg / kg intravenously twice daily or from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see section 4.2.
29 Rifabutin (300 mg én gang dagligt) nedsatte Cmax og AUCτ af voriconazol 200 mg 2 gange dagligt med henholdsvis 69% og 78%.
Rifabutin (300 mg once daily) decreased the Cmax and AUCτ of voriconazole at 200 mg twice daily by 69% and 78%, respectively.
Ved samtidig administration af rifabutin var Cmax og AUCτ af voriconazol 350 mg 2 gange dagligt 96% og 68% af de niveauer, der blev set, hvis der blev givet voriconazol 200 mg 2 gange dagligt alene.
29 rifabutin, the Cmax and AUCτ of voriconazole at 350 mg twice daily were 96% and 68% of the levels when administered alone at 200 mg twice daily.
Samtidig administration af voriconazol og et oralt kontraceptivt præparat (1 mg norethisteron og 0, 035 mg ethinylestradiol; 1 gang dagligt) hos raske kvindelige forsøgspersoner fører til en stigning i Cmax og AUCτ af ethinylestradiol (henholdsvis 36% og 61%), og norethisteron (henholdsvis 15% og 53%).
Coadministration of voriconazole and an oral contraceptive (1 mg norethisterone and 0.035 mg ethinylestradiol; once daily) in healthy female subjects resulted in increases in the Cmax and AUC of ethinylestradiol (36% and 61% respectively) and norethisterone (15% and 53% respectively).
Orale kontraceptiva, som indeholder doser større end 1 mg norethisteron og 0, 035 mg ehtinylestradiol, er ikke undersøgte.
Oral contraceptives containing doses other than 1 mg norethisterone and 0.035 mg ethinylestradiol have not been studied.
Standarddoser af voriconazol og standarddoser af efavirenz må ikke administreres samtidigt.
Standard doses of voriconazole and standard doses of efavirenz must not be coadministered.
Steady state efavirenz (400 mg oralt 1 gang dagligt) nedsatte steady state Cmax og AUCτ af voriconazol med et gennemsnit på henholdsvis 61% og 77% hos raske forsøgspersoner.
Steady-state efavirenz (400 mg orally once daily) decreased the steady state Cmax and AUCτ of voriconazole by an average of 61% and 77%, respectively, in healthy subjects.
30 I et separat forsøg med raske forsøgspersoner gav samtidig administration af 300 mg voriconazol 2 gange dagligt og lavdosis efavirenz (300 mg 1 gang dagligt) ikke tilstrækkelig eksponering af voriconazol.
In a separate study in healthy subjects, voriconazole dose of 300 mg BID in combination with low dose efavirenz (300 mg once daily) did not lead to sufficient voriconazole exposure.
Graviditet Der foreligger ikke tilstrækkelig data om brugen af VFEND hos gravide kvinder.
Pregnancy No adequate information on the use of VFEND in pregnant women is available.
31 Da størstedelen af studierne var åbne, er alle kausale bivirkninger, hvor der er en mulig årsagssammenhæng, anført efter systemorganklasse og frekvens (meget almindelig > 1/ 10, almindelig > 1/ 100 og < 1/ 10, ikke almindelig > 1/ 1000 og < 1/ 100, < 1/ 1000 og meget sjælden < 1/ 10. 000) i tabellen nedenfor.
In the table below, since the majority of the studies were of an open nature all causality adverse events, by system organ class and frequency (very common ≥ 1/ 10, common ≥ 1/ 100 and < 1/ 10, uncommon ≥ 1/ 1000 and < 1/ 100, rare, ≥ 1/ 10 000 and < 1/ 1000 and very rare, < 1/ 10 000) if possibly causally related are listed.
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
Within each frequency grouping, undesirable effects are presented in order
De alvorligste er anført først.
31 of decreasing seriousness.
De hyppigst rapporterede bivirkninger var synsforstyrrelse, pyreksi, udslæt, opkastning, kvalme, diarré, hovedpine, perifer ødem og abdominalsmerter.
The most commonly reported adverse events were visual disturbances, pyrexia, rash, vomiting, nausea, diarrhoea, headache, peripheral oedema and abdominal pain.
4. 4), kromatopsi og fotofobi)
Visual disturbances (including blurred vision (see Section 4.4), chromotopsia and photophobia)
32 Mave- tarmkanalen Meget almindelig Almindelig
32 Gastrointestinal disorders Very common Uncommon
33
33 Hepato-biliary disorders Common Uncommon
Brug hos børn Sikkerheden af voriconazol er undersøgt hos 245 pædiatriske patienter i alderen 2 til < 12 år, som blev behandlet med voriconazol i farmakokinetiske studier (87 pædiatriske patienter) og i ” compassionate use ” programmer (158 pædiatriske patienter).
Paediatric Use The safety of voriconazole was investigated in 245 paediatric patients aged 2 to < 12 years who were treated with voriconazole in pharmacokinetic studies (87 paediatric patients) and in compassionate use programs (158 paediatric patients).
Hos de 22 patienter under 2 år, som blev behandlet med voriconazol i et ” compassionate use ” program, er følgende bivirkninger (for hvilke en sammenhæng med voriconazol ikke kan udelukkes) rapporteret:
In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse events (for which a relationship to voriconazole
Lysfølsomme reaktioner (1), arytmi (1), pancreatitis (1), forhøjet serum- bilirubin (1), forhøjet antal leverenzymer (1), udslæt (1) og papilødem (1).
34 could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis (1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
34 4. 9 Overdosering
4.9 Overdose
Klinisk effekt (med delvist eller fuldstændigt respons, se neden for under Klinisk erfaring) er vist over for Aspergillus spp. herunder A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., herunder C. albicans C. glabrata, C. krusei, C. parapsilosis, C. tropicalis samt et begrænset antal af C. dubliniensis, C. inconspicua og C. guilliermondii, Scedosporium spp., herunder S. apiospermum, S. prolificans og Fusarium spp.
Clinical efficacy (with partial or complete response, see below under Clinical Experience) has been demonstrated for Aspergillus spp. including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans and Fusarium spp.
In vitro aktivitet over for følgende patogener er vist, men den kliniske betydning er ukendt:
35 In vitro activity against the following pathogens has been shown, but the clinical significance is unknown:
35 Artsbestemmelse af svampekultur og andre relevante laboratorieundersøgelser (serologi, histopatologi) bør foretages før behandling for at isolere og identificere de sygdomsfremkaldende mikroorganismer.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms.
Der sås tilfredstillende globalt respons (fuldstændigt eller delvis resolution af alle tilhørende symptomer, radiografiske/ bronkoskopiske abnormaliteter ved baseline) hos 53% af de voriconazolbehandlede patienter sammenlignet med 31% af patienterne behandlet med komparatoren.
A satisfactory global response (complete or partial resolution of all attributable symptoms signs, radiographic/ bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31% of patients treated with comparator.
Behandling af candidæmi hos non- neutropene patienter
Candidaemia in non-neutropenic patients.
Den forsøgsansvarliges vurdering af succesfuld resultat på et hvilket som helst af disse tidspunkter er vist i nedennævnte tabel:
The Investigator’ s assessment of successful outcome at each of these time points is shown in the following table.
De placebo- justerede gennemsnitlige maksimale stigninger i QTc i forhold til baseline
37 Clinical Studies Examining QT Interval A placebo-controlled, randomized, single-dose, crossover study to evaluate the effect on the QT interval of healthy volunteers was conducted with three oral doses of voriconazole and ketoconazole.
37 efter 800 mg, 1200 mg og 1600 mg voriconazol var henholdsvis 5, 1 msek., 4, 8 msek. og 8, 2 msek. og 7, 0 msek. for ketoconazol 800 mg.
The placebo-adjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg.
Ingen forsøgspersoner i nogen af grupperne havde en stigning i QTc på ≥60 msek. i forhold til baseline.
No subject in any group had an increase in QTc of ≥ 60 msec from baseline.
Prøver af cerebrospinalvæsken fra 8 patienter i et særligt klinisk program (” compassionate use ”) viste målbare voriconazolkoncentrationer hos alle patienter.
Cerebrospinal fluid samples from eight patients in a compassionate programme showed detectable oriconazole concentrations in all patients.
38 Udskillelse Voriconazol udskilles ved levermetabolisme, hvor mindre end 2% af dosis udskilles uforandret i urinen.
38 Excretion Voriconazole is eliminated via hepatic metabolism with less than 2% of the dose excreted unchanged in the urine.
Farmakokinetiske – farmakodynamiske relationer I 10 kliniske studier var medianen for gennemsnitlige og maksimale plasmakoncentrationer hos individuelle forsøgspersoner på tværs af studierne henholdsvis 2425 ng/ ml (inter- kvartil fra 1193 til 4380 ng/ ml) og 3742 ng/ ml (inter- kvartil fra 2027 til 6302 ng/ ml).
Pharmacokinetic-Pharmacodynamic relationships In 10 therapeutic studies, the median for the average and maximum plasma concentrations in individual subjects across the studies was 2425 ng/ ml (inter-quartile range 1193 to 4380 ng/ ml) and 3742 ng/ ml (inter-quartile range 2027 to 6302 ng/ ml), respectively.
Køn I et oralt flerdosisstudie med raske, unge kvinder var Cmax og AUCτ henholdsvis 83% og 113% højere, end hos raske, unge mænd (18- 45 år).
Gender In an oral multiple dose study, Cmax and AUCτ for healthy young females were 83% and 113% higher, respectively, than in healthy young males (18-45 years).
I samme studie blev der ikke observeret signifikante ændringer i Cmax og AUCτ mellem raske, ældre mænd og raske, ældre, kvinder (≥65 år).
In the same study, no significant differences in Cmax and AUCτ were observed between healthy elderly males and healthy elderly females (≥ 65 years).
Ældre I et oralt flerdosisstudie med raske, ældre mænd (≥65 år) var Cmax og AUCτ henholdsvis 61% og 86% højere end hos raske, unge mænd (18- 45 år).
Elderly In an oral multiple dose study Cmax and AUCτ in healthy elderly males (≥ 65 years) were 61% and 86% higher, respectively, than in healthy young males (18-45 years).
Der blev ikke observeret nogen signifikante forskelle i Cmax og AUCτ mellem raske, ældre kvinder (≥65 år) og raske, unge kvinder (18- 45 år).
No significant differences in Cmax and AUCτ were observed between healthy elderly females (≥ 65 years) and healthy young females (18- 45 years).
Hos pædiatriske patienter er der en generel trend mod lavere oral biotilgængelighed ved lavere legemsvægt og højere oral biotilgængelighed ved højere legemsvægt (nærmende sig den udstrækning der er vist hos voksne).
In paediatric patients there is a general trend towards low bioavailability at lower body weights and high bioavailability at higher body weights (approaching the extent
En initialdosis er ikke indiceret til 39 pædiatriske patienter.
39 demonstrated in adults).
Nedsat nyrefunktion I et oralt enkeltdosisstudie (200 mg) hos patienter med normal nyrefunktion og mild (kreatinin clearance 41- 60 ml/ min) til svært nedsat nyrefunktion (kreatinin clearance < 20 ml/ min) var voriconazols farmakokinetik ikke signifikant påvirket af nedsat nyrefunktion.
Renal impairment In an oral single dose (200 mg) study in subjects with normal renal function and mild (creatinine clearance 41-60 ml/ min) to severe (creatinine clearance < 20 ml/ min) renal impairment, the pharmacokinetics of voriconazole were not significantly affected by renal impairment.
40 6. 2 Uforligeligheder
40 Film-coat:
6. 6) – efter rekonstitution skal den fortyndes yderligere før administration.
Each ml contains 10 mg of voriconazole after reconstitution (see section 6.6) - once reconstituted further dilution is required before administration.
6. 1.
Excipient: each vial contains 217.6 mg sodium For a full list of excipients, see section 6.1.
Hvidt frysetørret pulver.
White lyophilised powder
Behandling af candidæmi hos ikke- neutrogene 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)
6. 6) før administration som intravenøs infusion.
VFEND requires reconstitution and dilution (see section 6.6) prior to administration as an intravenous infusion.