natgillin/translations-raw huggingface dataset:
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.
55 Microbiology 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.
Andre behandlede svampeinfektioner (med hyppigt delvist eller fuldstændigt respons) omfatter isolerede tilfælde af Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserholium rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. herunder P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis og Trichosporon spp. herunder T. beigelii infektioner.
Other treated fungal infections (with often partial or complete response, see below under Clinical Experience) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp. including T. beigelii infections.
55 In vitro aktivitet over for kliniske isolater er set over for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum, hvor de fleste stammer bliver hæmmet af voriconazolkoncentrationer i området fra 0, 05 til 2 μg/ ml.
In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2µg/ ml.
In vitro aktivitet over for følgende patogener er vist, men den kliniske betydning er ukendt:
In vitro activity against the following pathogens has been shown, but the clinical significance is unknown:
Positivt resultat defineres i dette afsnit som fuldstændigt eller delvis respons.
Clinical Experience Succesful outcome in this section is defined as complete or partial response.
370 non- neutropene patienter (over 12 år) med påvist candidæmi blev inkluderet i studiet.
Three hundred and seventy non-neutropenic patients (above 12 years of
Heraf blev 248 behandlet med voriconazol.
56 age) with documented candidaemia were included in the study, of whom 248 were treated with voriconazole.
Patienter, som ikke blev vurderet 12 uger efter endt
Patients who did not have an assessment 12 weeks after EOT were counted as failures.
Alvorlige refraktære Candida- infektioner Studiet omfatter 55 patienter med alvorlige refraktære systemiske Candida- infektioner (herunder candidæmi, dissemineret og andre invasive candidiasis), hvor tidligere antimykotisk behandling, især med fluconazol ikke har været effektivt.
Serious refractory Candida infections The study comprised 55 patients with serious refractory systemic Candida infections (including candidaemia, disseminated and other invasive candidiasis) where prior antifungal treatment, particularly with fluconazole, had been ineffective.
I fluconazol resistente ikke albicans arter er et succesfuldt resultat set hos 3/ 3 C. krusei (fuldstændigt respons) og 6/ 8 C. glabrata (5 med fuldstændigt, 1 med delvist respons) infektioner.
In fluconazole-resistant non albicans species, a successful outcome was seen in 3/ 3 C. krusei (complete responses) and 6/ 8 C. glabrata (5 complete, 1 partial response) infections.
Succesrigt respons på voriconazol behandling blev set hos 16 (6 med fuldstændigt, 10 med delvist respons) ud af 28 patienter med S. apiospermum og hos 2 (begge med delvist respons) ud af 7 patienter med S. prolificans infektion.
Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial response) of 7 patients with S. prolificans infection.
Erfaring med pædiatriske patienter 61 pædiatriske patienter i alderen 9 måneder til 15 år, som havde fået diagnosticeret eller havde sandsynligvis invasiv svampeinfektion, blev behandlet med voriconazol.
57 Experience in paediatric patients Sixty one paediatric patients aged 9 months up to 15 years who had definite or probable invasive fungal infections, were treated with voriconazole.
57 ondartede hæmatologiske sygdomme og aplastisk anæmi (27 patienter) og kronisk granulomatose (14 patienter).
Underlying diseases in these patients included haematological malignancies and aplastic anaemia (27 patients) and chronic granulomatous disease (14 patients).
Et placebokontrolleret, randomiseret, enkeltdosis, crossover studie, der undersøgte effekten på QT - intervallet hos raske frivillige forsøgspersoner, blev udført med 3 orale doser af voriconazol og ketoconazol.
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.
De placebo- justerede gennemsnitlige maksimale stigninger i QTc i forhold til baseline 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.
Den inter- individuelle variabilitet af voriconazols farmakokinetik er høj.
58 The inter-individual variability of voriconazole pharmacokinetics is high.
Personer, som er heterozygotisk 58 kraftigt metaboliserende har gennemsnitligt fordoblet voriconazol eksponering i forhold til deres homozygotisk kraftigt metaboliserende modparter.
Subjects who are heterozygous extensive metabolisers have on average 2- fold higher voriconazole exposure than their homozygous extensive metaboliser counterparts.
Denne metabolit har minimal antimykotisk effekt, og den bidrager ikke til voriconazols samlede effekt.
This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole
Efter administration af en radioaktivt mærket dosis af voriconazol bliver næsten 80% af radioaktiviteten genfundet i urinen efter gentagne intravenøse doser og 83% i urinen efter gentagne orale doser.
After administration of a radiolabelled dose of voriconazole, approximately 80% of the radioactivity is recovered in the urine after multiple intravenous dosing and 83% in the urine after multiple oral dosing.
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).
I de kliniske studier blev der ikke foretaget dosisjusteringer på baggrund af alder.
59 In the therapeutic studies no dosage adjustment was made on the basis of age.
Børn Den anbefalede intravenøse dosis for børn er baseret på en farmakokinetisk populationsanalyse af data indsamlet fra 82 immunkompromitterede pædiatriske patienter i alderen 2 til < 12 år, som blev evalueret i 3 farmakokinetiske studier (af enkelte intravenøse doser på 3 og 4 mg/ kg 2 gange dagligt, gentagne intravenøse doser på 3, 4, 6 og 8 mg/ kg 2 gange dagligt og multiple orale suspensionsdoser 59 på 4 og 6 mg/ kg 2 gange dagligt).
Paediatrics The recommended intravenous dose in paediatric patients is based on a population pharmacokinetic analysis of data pooled from 82 immunocompromised paediatric patients aged 2 to < 12 years old who were evaluated in three pharmacokinetic studies (examining single intravenous doses of 3 and 4 mg/ kg twice daily, multiple intravenous doses of 3, 4, 6 and 8 mg/ kg twice daily and multiple oral suspension doses of 4 and 6 mg/ kg twice daily).
Hovedparten af patienterne fik mere end et dosisniveau med en maksimal behandlingstid på 30 dage.
The majority of patients received more than one dose level with a maximum duration of dosing of 30 days.
En sammenligning af de farmakokinetiske populationsdata fra børn og voksne indikerer, at en intravenøs vedligeholdelsesdosis på 7 mg/ kg 2 gange dagligt er påkrævet hos pædiatriske patienter for at kunne opnå sammenlignelige eksponeringer til de hos voksne opnåede vedligeholdelsesdoser efter en intravenøs administration på 4 mg/ kg 2 gange dagligt.
A comparison of the paediatric and adult population pharmacokinetic data indicated that in order to obtain comparable exposures to those obtained in adults following intravenous maintenance doses of 4 mg/ kg twice daily, intravenous maintenance doses of 7 mg/ kg twice daily are required in paediatric patients.
Den højere intravenøse vedligeholdelsesdosis hos pædiatriske patienter i forhold til voksne afspejler den højere elimineringskapacitet hos pædiatriske patienter, pga. en større lever/ legemsvægt- ratio.
The higher intravenous maintenance dose in paediatric patients relative to adults reflects the higher elimination capacity in paediatric patients due to a greater liver mass to body mass ratio.
For at opnå sammenlignelige eksponeringer til de hos voksne opnåede vedligeholdelsesdoser efter intravenøs administration på 3 mg/ kg 2 gange dagligt, er det hos børn påkrævet med intravenøse vedligeholdelsesdoser på 4 mg/ kg 2 gange dagligt,
In order to obtain comparable exposures to those obtained in adults following intravenous maintenance doses of 3 mg/ kg twice daily, intravenous maintenance doses of 4 mg/ kg twice daily are required in paediatric patients.
Baseret på den farmakokinetisk populationsanalyse er det ikke berettiget med en initialdosis eller dosisjustering pga. alder, for børn i alderen 2 til < 12 år.
Based on the population pharmacokinetic analysis, no loading dose or dosage adjustment according to age is warranted in patients aged 2 to < 12 years old.
Nedsat nyrefunktion Hos patienter med moderat til alvorlig nyrefunktionssvigt (serum- kreatininniveauer > 2, 5 mg/ dl), ses akkumulering af hjælpestoffet SBECD i intravenøst VFEND.
Renal impairment In patients with moderate to severe renal dysfunction (serum creatinine levels > 2.5 mg / dl), accumulation of the intravenous vehicle, SBECD, occurs.
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 to 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.
I reproduktionsforsøg har voriconazol vist sig at være teratogent hos rotter og embryotoksisk hos kaniner ved systemisk optagelse svarende til den der ses ved terapeutiske doser hos mennesker.
In reproduction studies, voriconazole was shown to be teratogenic in rats and embryotoxic in rabbits at systemic exposures equal to those obtained in humans with therapeutic doses.
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.
Prækliniske data vedrørende hjælpestoffet SBECD i intravenøst VFEND tyder på at de primære virkninger er vakuolisering af urinvejsepithelium og aktivering af makrofager i lever og lunger i toksicitetsforsøg efter gentagne doser.
60 Preclinical data on the intravenous vehicle, SBECD indicated that the main effects were vacuolation of urinary tract epithelium and activation of macrophages in the liver and lungs in the repeated-dose toxicity studies.
Karcinogenicitetsforsøg er ikke udført med SBECD.
Carcinogenicity studies were not performed with SBECD.
Denne urenhed bør anses for at være en substans med karcinogene 60 egenskaber hos mennesker.
This impurity should be considered a substance with carcinogenic potential in humans.
Sulfobutylether beta cyclodextrinnatrium (SBECD).
Sulphobutylether beta cyclodextrin sodium (SBECD)
Når VFEND- infusionen er tilendebragt, kan dropslangen anvendes til administration af andre intravenøse produkter.
When the VFEND infusion is complete, the line may be used for administration of other intravenous products.
4. 2 og 4. 4).
Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to initiation of voriconazole therapy (see section 4.2 and section 4.4).
Total parenteral ernæring (TPN) behøver ikke at blive afbrudt, når der udskrives VFEND, men de skal infunderes i hver sin dropslange.
Total parenteral nutrition (TPN) need not be discontinued when prescribed with VFEND, but does need to be infused through a separate line.
Hvis det infunderes gennem et multi- lumen kateter, skal TPN administreres i en anden port end den, der benyttes til VFEND.
If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for VFEND.
VFEND må ikke fortyndes med 4, 2% Natriumcarbonat infusionsvæske.
VFEND must not be diluted with 4.2% Sodium Bicarbonate Infusion.
VFEND pulver til infusionsvæske, opløsning:
VFEND powder for solution for infusion:
Ud fra et mikrobiologisk synspunkt skal præparatet derfor bruges med det samme efter rekonstitution.
Therefore, from a microbiological point of view, once reconstituted, the product must be used immediately.
Anvendelse af andre opbevaringsbetingelser er på brugerens eget ansvar og må ikke overstige 24 timer ved 2°C- 8°C, medmindre rekonstitution er foretaget under kontrollerede og validerede aseptiske forhold.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Der er vist kemisk og fysisk stabilitet i 24 timer ved 2°C- 8°C.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Rekonstitueret koncentrat:
Reconstituted concentrate:
Opbevares ved 2°C - 8°C op til 24 timer (i køleskab).
Store at 2°C-8°C for up to 24 hours (in a refrigerator).
6. 5 Emballage og pakningsstørrelser
61 6.5 Nature and contents of container
Hætteglasset er lukket med gummiprop og aluminiumhætte med plastikforsegling.
Packs of 1 single use 30 ml clear Type I glass vials with rubber stoppers and aluminium caps with plastic seals.
61 6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal and other handling
Pulveret skal fortyndes med 19 ml vand til injektionsvæsker for at opnå et klart koncentrat, hvorfra der kan trækkes et volumen på 20 ml, der indeholder 10 mg/ ml voriconazol.
The powder is reconstituted with 19 ml of Water for Injections to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ ml of voriconazole.
VFEND- hætteglasset kasseres, hvis vakuum ikke kan trække fortyndingsmidlet op i hætteglasset.
Discard the VFEND vial if vacuum does not pull the diluent into the vial.
Det anbefales at anvende en standard 20 ml (ikke- automatiseret) sprøjte for at sikre, at det præcise volumen (19, 0 ml) vand til injektionsvæsker tilsættes.
It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact amount (19.0 ml) of Water for Injections is dispensed.
Kun klare opløsninger uden partikler må anvendes.
This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.
Ved administration tilsættes det krævede volumen af det rekonstituerede koncentrat til en anbefalet forligelig infusionsopløsning (detaljer nedenfor) for at opnå en endelig voriconazol opløsning på 0, 5- 5 mg/ ml.
For administration, the required volume of the reconstituted concentrate is added to a recommended compatible infusion solution (detailed below) to obtain a final voriconazole solution containing 0.5-5 mg/ ml.
Nødvendig mængde af 10 mg/ ml VFEND koncentrat
Required Volumes of 10 mg/ ml VFEND Concentrate
Nødvendig mængde af Vfend koncentrat (10 mg/ ml):
Volume of VFEND Concentrate (10 mg/ ml) required for:
(antal hætteglas) (antal
Body Weight (kg) 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
hætteglas) (antal hætteglas) (antal hætteglas)
3 mg/ kg dose (number of vials) - - - - 9.0 ml (1) 10.5 ml (1) 12.0 ml (1) 13.5 ml (1) 15.0 ml (1) 16.5 ml (1) 18.0 ml (1) 19.5 ml (1) 21.0 ml (2) 22.5 ml (2) 24.0 ml (2) 25.5 ml (2) 27.0 ml (2) 28.5 ml (2) 30.0 ml (2)
- - - - 9, 0 ml (1) 10, 5 ml (1) 12, 0 ml (1) 13, 5 ml (1) 15, 0 ml (1) 16, 5 ml (1) 18, 0 ml (1) 19, 5 ml (1) 21, 0 ml (2) 22, 5 ml (2) 24, 0 ml (2) 25, 5 ml (2) 27, 0 ml (2) 28, 5 ml (2) 30, 0 ml (2)
4 mg/ kg dose (number of vials) 4.0 ml (1) 6.0 ml (1) 8.0 ml (1) 10.0 ml (1) 12.0 ml (1) 14.0 ml (1) 16.0 ml (1) 18.0 ml (1) 20.0 ml (1) 22.0 ml (2) 24.0 ml (2) 26.0 ml (2) 28.0 ml (2) 30.0 ml (2) 32.0 ml (2) 34.0 ml (2) 36.0 ml (2) 38.0 ml (2) 40.0 ml (2)
4, 0 ml (1) - 7, 0 6, 0 ml (1) - 10, 5 8, 0 ml (1) - 14, 0 10, 0 ml (1) - 17, 5 12, 0 ml (1) 18, 0 ml (1) 21, 0 14, 0 ml (1) 21, 0 ml (2) 24, 5 16, 0 ml (1) 24, 0 ml (2) 28, 0 18, 0 ml (1) 27, 0 ml (2) 31, 5 20, 0 ml (1) 30, 0 ml (2) 35, 0 22, 0 ml (2) 33, 0 ml (2) 24, 0 ml (2) 36, 0 ml (2) 26, 0 ml (2) 39, 0 ml (2) 28, 0 ml (2) 42, 0 ml (3) 30, 0 ml (2) 45, 0 ml (3) 32, 0 ml (2) 48, 0 ml (3) 34, 0 ml (2) 51, 0 ml (3) 36, 0 ml (2) 54, 0 ml (3) 38, 0 ml (2) 57, 0 ml (3) 40, 0 ml (2) 60, 0 ml (3)
6 mg/ kg dose (number of vials) - - - - 18.0 ml (1) 21.0 ml (2) 24.0 ml (2) 27.0 ml (2) 30.0 ml (2) 33.0 ml (2) 36.0 ml (2) 39.0 ml (2) 42.0 ml (3) 45.0 ml (3) 48.0 ml (3) 51.0 ml (3) 54.0 ml (3) 57.0 ml (3) 60.0 ml (3)
ml (1) ml (1) ml (1) ml (1) ml (2) ml (2) ml (2) ml (2) ml (2) - - - - - - - - - -
7 mg/ kg dose (number of vials) 7.0 ml (1) 10.5 ml (1) 14.0 ml (1) 17.5 ml (1) 21.0 ml (2) 24.5 ml (2) 28.0 ml (2) 31.5 ml (2) 35.0 ml (2) - - - - - - - - - -
Voriconazol er et ukonserveret, sterilt, frysetørret lægemiddel til éngangsbrug.
Voriconazole is a single dose unpreserved sterile lyophile.
Ud fra et mikrobiologisk synspunkt skal præparatet derfor bruges med det samme efter rekonstitution.
Therefore, from a microbiological point of view, the reconstituted solution must be used immediately.
Anvendelse af andre opbevaringsbetingelser er på brugerens eget ansvar og må ikke overstige 24 timer ved 2°C- 8°C, medmindre rekonstitution er foretaget under kontrollerede og validerede aseptiske forhold.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Den rekonstituerede opløsning kan fortyndes med:
62 The reconstituted solution can be diluted with:
9 mg/ ml (0, 9%) natriumchlorid intravenøs infusion Ringer- Lactat intravenøs infusion 5% glucose og Ringer- Lactat intravenøs infusion 5% glucose og 0, 45% natriumchlorid intravenøs infusion 5% glucose intravenøs infusion 5% glucose i 20 milliækvivalenter kaliumchlorid intravenøs infusion 62 0, 45% natriumchlorid intravenøs infusion 5% glucose og 0, 9% natriumchlorid intravenøs infusion
9 mg/ ml (0.9%) Sodium Chloride for Infusion Lactated Ringer’ s Intravenous Infusion 5% Glucose and Lactated Ringer’ s Intravenous Infusion 5% Glucose and 0.45% Sodium Chloride Intravenous Infusion 5% Glucose Intravenous Infusion 5% Glucose in 20 mEq Potassium Chloride Intravenous Infusion 0.45% Sodium Chloride Intravenous Infusion 5% Glucose and 0.9% Sodium Chloride Intravenous Infusion
6. 2, er ikke kendt.
The compatibility of voriconazole with diluents other than described above or in section 6.2 is unknown.
21. marts 2002 Date for seneste fornyelse:
21 March 2002 Date of last renewal:
VFEND 40 mg/ ml pulver til oral suspension
VFEND 40 mg/ ml powder for oral suspension
6. 6).
Each ml of oral suspension contains 40 mg of voriconazole when reconstituted with water (see section 6.6).
Hver flaske indeholder 3 g voriconazol Hjælpestoffer:
Excipient:
Hvidt til råhvidt pulver
White to off-white powder
VFEND findes også som 50 mg og 200 mg filmovertrukne tabletter og 200 mg pulver til infusionsvæske, opløsning.
VFEND is also available as 50 mg and 200 mg film-coated tablets and 200 mg powder for solution for injection.
64 Detaljeret information om dosisanbefalinger ses i følgende tabel:
64 Detailed information on dosage recommendations is provided in the following table:
Patienter 40 kg derover
Patients 40 kg and above
Oral suspension og Patienter under 40 kg
Patients less than 40 kg
Initialdosis
Loading Dose
6 mg/ kg hver 12. time
6 mg/ kg every 12 hours
400 mg (10 ml) hver 12.
400 mg (10 ml) every
200 mg (5 ml) hver
200 mg (5 ml) every 12
(i de første 24
(for the first 24 hours)
timer)
12 hours (for the first
(i de første 24 timer)
hours (for the first 24
time (i de første 24 timer)
(first 24 hours)
12. time (i de første 24 timer)
24 hours)
Vedligeholdelsesdosis (efter de første 24 timer)
Maintenance Dose
200 mg (5 ml) 2 gange dagligt
200 mg (5 ml) twice
100 mg (2, 5 ml) 2 gange dagligt
100 mg (2.5 ml) twice
5. 2).
65 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).
Oral suspension **
Oral Suspension**
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 2- < 12.
4. 5).
66 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:
Monitoring of renal function:
67 Monitorering af pancreasfunktionen:
67 Monitoring of pancreatic function:
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.
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 reactions to rifabutin (e. g. uveitis) is recommended when rifabutin is coadministered with voriconazole.