FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that all patients, including children, avoid exposure to direct sunlight during VORICONAZOLE HIKMA treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Danish: Det anbefales, at alle patienter, herunder også børn, undgår udsættelse for sollys under VORICONAZOLE HIKMA-behandling.
English: • Allergic skin reactions (sometimes severe), including life-threatening skin condition that causes painful blisters and sores of the skin and mucous membranes, especially in the mouth inflammation of the skin hives, sunburn or severe skin reaction following exposure to light or sun,
Danish: • Allergiske hudreaktioner (undertiden alvorlige), herunder livstruende hudsygdom, der giver smertende blærer og sår på hud og slimhinder, især i munden, betændelse i huden, nældefeber, solskoldning eller kraftige hudreaktioner pga. lys eller solens stråler, hudrødme og hudirritation, rød eller violet misfarvning af huden, som kan være forårsaget af et lavt antal blodplader, eksem
English: Voriconazole (N=98)
Danish: Voriconazol (n=98)
English: 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 or sodium chloride 9 mg/ml (0.9%) solution for injection is dispensed.
Danish: Det anbefales at anvende en standard 20 ml (ikkeautomatiseret) sprøjte for at sikre, at det præcise volumen (19,0 ml) vand til injektionsvæsker eller natriumchlorid-infusionsvæske 9 mg/ml (0,9 %) tilsættes.
English: Treatment should be as short as possible, however, if based on the benefit-risk assessment the treatment is continued (see section 4.2), monitoring frequency can be reduced to monthly if there are no changes in the liver function tests.
Danish: 4.2), kan monitoreringsfrekvensen reduceres til én gang om måneden, hvis der ikke er ændringer i leverfunktionsværdierne.
English: • Inflammation of the sinuses, inflammation of the gums, chills, weakness
Danish: • Bihulebetændelse, betændelse i gummerne, kulderystelser, svaghed
English: Although not studied, voriconazole is likely to significantly increase the plasma concentrations of everolimus.
Danish: Selvom det ikke er undersøgt, vil voriconazol sandsynligvis forhøje plasmakoncentrationerne af everolimus signifikant.
English: Oral bioavailability may be limited in paediatric patients aged 2 to <12 years with malabsorption and very low body weight for age.
Danish: Hos pædiatriske patienter i alderen 2 til <12 år, med malabsorption og meget lav legemsvægt for deres alder kan den orale biotilgængelighed være begrænset.
English: In the case of treatment-related adverse events, discontinuation of voriconazole and use of alternative antifungal agents must be considered (see section 4.4 and 4.8)
Danish: I tilfælde af behandlingsrelaterede bivirkninger skal seponering af voriconazol og anvendelse af alternative antimykotika overvejes (se pkt.
English: Ergot alkaloids (e.g., ergotamine and dihydroergotamine) [CYP3A4 substrates]
Danish: Sekalealkaloider (f.eks. ergotamin og dihydroergotamin) [CYP3A4-substrater]
English: Eye disorders visual impairment6
Danish: Øjne synsnedsættelse6
English: Three hundred and seventy non-neutropenic patients (above 12 years of age) with documented candidaemia were included in the study, of whom 248 were treated with voriconazole.
Danish: 370 non-neutropene patienter (over 12 år) med påvist candidæmi blev inkluderet i studiet.
English: 6 mg/kg every 12 hours for the first 24 hours
Danish: 6 mg/kg hver 12. time i de første 24 timer
English: Excipient: Sulpfobutylether beta cyclodextrin sodium (SBECD).
Danish: Hjælpestof: Sulfobutylether-beta-cyclodextrinnatrium (SBECD).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Voriconazole Hikma 200 mg powder for infusion Voriconazole
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Voriconazole Hikma 200 mg pulver til infusionsvæske Voriconazol
English: • Exfoliative cutaneous reactions
Danish: Eksfoliative kutanreaktioner
English: IFI while on study drug * Primary endpoint of the study ** Difference in proportions, 95% CI and p-values obtained after adjustment for randomization
Danish: Udviklet påvist eller sandsynlig invasiv svampeinfektion under behandling med studielægemiddel * Studiets primære effektmål ** Forskel i andele, 95% konfidensinterval og opnåede p-værdier efter justering for randomisering
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 200 mg of voriconazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 200 mg voriconazol.
English: - The other ingredient is sulfobutylether beta cyclodextrin sodium.
Danish: - Øvrigt indholdsstof: sulfobutylether-beta-cyclodextrinnatrium.
English: Endocrine disorders adrenal insufficiency, hypothyroidism hyperthyroidism
Danish: Det endokrine system binyrebarkinsufficiens, hypotyreose hypertyreose
English: Statins (e.g., lovastatin) [CYP3A4 substrates]
Danish: Statiner (f.eks. lovastatin) [CYP3A4-substrater]
English: Dose reduction of alfentanil, fentanyl and other short acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered.
Danish: Det bør overvejes at reducere dosis af alfentanil, fentanyl samt andre korttidsvirkende opiater, hvis struktur ligner alfentanil og metabliseres af CYP3A4 (f.eks. sufentanil).
English: • Visual impairment (change in vision including blurred vision, visual color alterations, abnormal intolerance to visual perception of light, colour blindness, eye disorder, halo vision, night blindness,
Danish: • Nedsat syn (ændring i synet såsom sløret syn, ændringer i farvesyn, unormal manglende tolerance ved synsopfattelse af lys, farveblindhed, øjensygdom, lyscirkler, natteblindhed, gyngende syn, gnister, synsaura, nedsat sysnskarphed, synsklarhed, tab af dele af det sædvanlige synsfelt, pletter for øjnene)
English: Common: may affect up to 1 in 10 people
Danish: Almindelige: Det forekommer hos op til 1 ud af 10 patienter
English: • Enlarged liver, liver failure, gallbladder disease, gallstones
Danish: • Forstørret lever, leversvigt, problemer med galdeblæren, galdesten
English: 9 mg/kg every 12 hours for the first 24 hours
Danish: 9 mg/kg hver 12. time i de første 24 timer
English: A higher frequency of liver enzyme elevations was observed in the paediatric population (see section 4.8).
Danish: Hos den pædiatriske population ses en højere hyppighed af leverenzymstigninger (se pkt.
English: During infusion of the intravenous formulation of voriconazole in healthy subjects, anaphylactoid-type reactions, including flushing, fever, sweating, tachycardia, chest tightness, dyspnoea, faintness, nausea, pruritus and rash have occurred.
Danish: Under intravenøs infusion af voriconozol hos raske frivillige forsøgspersoner er der set tilfælde af anafylaktoid-lignende reaktioner, omfattende rødmen (”flushing”), feber, svedtendens, takykardi, trykken for brystet, dyspnø, mathedsfølelse, kvalme, kløe og udslæt.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: Det forekommer hos op til 1 ud af 100 patienter
English: Long term exposure to voriconazole greater than 180 days (6 months) requires careful assessment of the benefit-risk balance (see sections 4.4 and 5.1).
Danish: Langtidseksponering for voriconazol i mere end 180 dage (6 måneder) kræver nøje vurdering af benefit/risk-forholdet (se pkt.
English: If a patient develops skeletal pain and radiologic findings compatible with periostitis VORICONAZOLE HIKMA discontinuation should be considered after multidisciplinary advice.
Danish: Hvis en patient oplever knoglesmerter, og radiologiske undersøgelser peger på periostitis, bør der søges multidisciplinær rådgivning og seponering af VORICONAZOLE HIKMA bør overvejes.
English: unspecified (including cysts and polyps) Blood and lymphatic system disorders agranulocytosis1, pancytopenia, thrombocytopenia2, leukopenia, anaemia bone marrow failure, lymphadenopathy, eosinophilia disseminated intravascular coagulation
Danish: Blod og lymfesystem agranulocytose1, pancytopeni, trombocytopeni2, leukopeni, anæmi knoglemarvssvigt, lymfadenopati, eosinofili dissemineret intravaskulær koagulation
English: retinal haemorrhage optic nerve disorder7, papilloedema8, oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
Danish: retinablødning sygdom i synsnerven7, papilødem8, okulogyrisk krise, diplopi, skleritis, blefaritis optisk atrofi, corneauklarhed
English: 8 mg/kg twice a day
Danish: 8 mg/kg 2 gange dagligt
English: 4 mg/kg twice a day
Danish: 4 mg/kg 2 gange dagligt
English: Although not studied clinically, voriconazole is likely to increase the plasma concentrations of benzodiazepines that are metabolised by CYP3A4 and lead to a prolonged sedative effect.
Danish: Selvom det ikke er undersøgt klinisk, er det sandsynligt, at voriconazol kan øge plasmakoncentrationerne af benzodiazepiner, der metaboliseres af CYP3A4, og føre til forlængelse af den sedative virkning.
English: Some medicines, when taken at the same time as Voriconazole Hikma, may affect the way that Voriconazole Hikma works or Voriconazole Hikma may affect the way they work.
Danish: Visse typer medicin kan påvirke virkningen af Voriconazole Hikma, eller Voriconazole Hikma kan påvirke virkningen af anden medicin, når den tages samtidig med Voriconazole Hikma.
English: Reduction in the dose of oxycodone and other long-acting opiates metabolized by CYP3A4 (e.g., hydrocodone) should be considered when coadministered with voriconazole.
Danish: Dosisreduktion af oxycodon og andre langtidsvirkende opiater, som metaboliseres af CYP3A4 (f.eks. hydrocodon), bør overvejes ved samtidig administration af voriconazol.
English: In an independent published study, Fentanyl AUC∞ ↑ 1.34-fold
Danish: I et uafhængigt, publiceret studie Fentanyl AUC0-∞ ↑ 1,34 gange
English: METHOD OF ADMINISTRATION
Danish: samtidig administration
English: 300 mg QD (co-administered with voriconazole 400 mg BID)*
Danish: 300 mg QD (administreret sammen med voriconazol 400 mg BID)*
English: Oral voriconazole should be administered to these patients, unless an assessment of the risk benefit to the patient justifies the use of intravenous voriconazole.
Danish: Disse patienter bør have voriconazol oralt, medmindre fordelen ved administration af intravenøst voriconazol opvejer den potentielle risiko.
English: After reconstitution with 19 ml of water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, a clear solution is obtained.
Danish: Efter rekonstituering med 19 ml vand til injektionsvæsker eller natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, opnås der en klar opløsning.
English: 4 mg/kg twice daily 200 mg twice daily
Danish: 4 mg/kg 2 gange dagligt 200 mg 2 gange dagligt 100 mg 2 gange dagligt
English: The maintenance dose of voriconazole may be increased to 5 mg/kg intravenously BID or from 200 mg to 350 mg orally BID (100 mg to 200 mg orally BID in patients less than 40 kg) (see section 4.2).
Danish: BID eller fra 200 mg til 350 mg oralt BID (100 mg til 200 mg oralt BID hos patienter, der vejer mindre end 40 kg) (se pkt.
English: Voriconazole Cmax ↑ 34% Voriconazole AUCτ ↑ 39%
Danish: Voriconazol Cmax ↑ 34 % Voriconazol AUCτ ↑ 39 %
English: Voriconazole was administered intravenously with a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours for a minimum of seven days.
Danish: hver 12. time de første 24 timer efterfulgt af en vedligeholdelsesdosis på 4 mg/kg hver 12. time i minimum 7 dage.
English: 2 In clinical studies, response to voriconazole in patients with C glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis.
Danish: 2 I kliniske studier var responset på voriconazol 21 % lavere hos patienter med infektion med C.
English: Rare (may affect up to 1 in 1000 people)
Danish: Sjældne : Det forekommer hos op til 1 ud af 1.000 patienter
English: Skin and subcutaneous tissue disorders rash dermatitis exfoliative, alopecia, rash maculo-papular, pruritus, erythema
Danish: Hud og subkutane væv udslæt eksfoliativ dermatitis, alopeci, makulopapuløst hududslæt, pruritus, erytem
English: Rifabutin or phenytoin may be co-administered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg intravenously twice daily, see sections 4.4 and 4.5.
Danish: Dosisjusteringer i tilfælde af samtidig administration Rifabutin eller phenytoin kan administreres sammen med voriconazol, hvis vedligeholdelsesdosis af voriconazol øges til 5 mg/kg intravenøst to gange dagligt, se pkt.
English: There have been reports of prolonged visual adverse reactions, including blurred vision, optic neuritis and papilloedema (see section 4.8).
Danish: Der er rapporteret om langvarige synsrelaterede bivirkninger, herunder sløret syn, betændelse i synsnerven og papilødem (se pkt.
English: *Oral dosage forms of voriconazole are available from other manufacturers Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.
Danish: Bemærk: Baseret på en farmakokinetisk populationsanalyse hos 112 immunkompromitterede pædiatriske patienter i alderen 2 til <12 år og 26 immunkompromitterede patienter i alderen 2 til <17 år.
English: The safety profile of voriconazole in young and elderly patients was similar and, therefore, no dosage adjustment is necessary for the elderly (see section 4.2).
Danish: I de kliniske studier blev der ikke foretaget dosisjusteringer på baggrund af alder. Der blev observeret sammenhæng mellem plasmakoncentrationer og alder. Voriconazols sikkerhedsprofil var ens hos både unge og ældre patienter, hvorfor en dosisjustering hos de ældre ikke er nødvendig (se pkt.
English: There is a small chance that skin cancer could develop with long term use of Voriconazole Hikma.
Danish: Der er en lille risiko for, at langvarig brug af Voriconazole Hikma kan forårsage hudkræft.
English: Voriconazole Hikma 200 mg powder for solution for infusion Voriconazole
Danish: Voriconazole Hikma 200 mg pulver til infusionsvæske, opløsning Voriconazol
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for infusion
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Pulver til infusionsvæske, opløsning 1 hætteglas
English: Voriconazole also significantly increases efavirenz plasma concentrations (see section 4.5, for lower doses see section 4.4).
Danish: Voriconazol øger også plasmakoncentrationen af efavirenz signifikant (se pkt.
English: When Voriconazole Hikma treatment is stopped by your doctor you should not experience any effects.
Danish: Når Deres læge stopper behandlingen med Voriconazole Hikma, bør De ikke kunne mærke det.
English: AT / BE / DE / NL Hikma Pharma GmbH Tel: +49 89-45450-302
Danish: Tel: +49 89-45450-302
English: Voriconazole administration induced no impairment of male or female fertility in rats at exposures similar to those obtained in humans at therapeutic doses.
Danish: Dyrestudier viste ikke nedsat fertilitet hos han- og hunrotter efter eksponeringer svarende til dem, der opnås hos mennesker efter indgift af voriconazol i terapeutiske doser.
English: On the basis of the high oral bioavailability (96 %; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Danish: 5.2) kan man skifte mellem intravenøs og oral administration, når det er klinisk indiceret.
English: Reduction in the dose of alfentanil, fentanyl and other short acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered when co-administered with voriconazole (see section 4.5).
Danish: Dosisreduktion af alfentanil, fentanyl og andre korttidsvirkende opiater, der har samme struktur som alfentanil, og som metaboliseres af CYP3A4 (f.eks. sufentanil), bør overvejes ved samtidig administration af voriconazol (se pkt.
English: When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5).
Danish: Når behandlingen med voriconazol stoppes, skal den initiale efavirenz-dosis genoptages (se pkt.
English: Sodium Chloride 9 mg/ml (0.9%) Solution for Injection Compound Sodium Lactate Intravenous Infusion 5% Glucose and Lactated Ringer's Intravenous Infusion
Danish: Natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning Ringer-Lactat infusionsvæske
English: Voriconazole Cmax ↑ 18% Voriconazole AUCτ ↑ 23%
Danish: Voriconazol Cmax ↑ 18 % Voriconazol AUCτ ↑ 23 %
English: Study Endpoints
Danish: Studiets effektmål
English: The oral maintenance dose of 200 mg (or 100 mg for patients less than 40 kg) achieves a voriconazole exposure similar to 3 mg/kg IV. A 300 mg (or 150 mg for patients less than 40 kg) oral maintenance dose achieves an exposure similar to 4 mg/kg IV.
Danish: En oral vedligeholdelsesdosis på 300 mg (eller 150 mg for patienter <40 kg) resulterer i eksponering svarende til 4 mg/kg i.v.
English: Visual impairments
Danish: • Smagsforstyrrelser
English: S-Ibuprofen Cmax ↑ 20% S-Ibuprofen AUC0-∞ ↑ 100%
Danish: S-Ibuprofen Cmax ↑ 20 % S-Ibuprofen AUC0-∞ ↑ 100 % Diclofenac Cmax ↑ 114 % Diclofenac AUC0-∞ ↑ 78 %
English: The following information is intended for healthcare professionals only:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale: Information om rekonstituering og fortynding
English: Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to initiation of voriconazole therapy (see sections 4.2 and 4.4).
Danish: Elektrolytforstyrrelser såsom hypokaliæmi, hypomagnesæmi og hypokalcæmi bør korrigeres, før voriconazolbehandling initieres (se pkt.
English: In an independent published study, Alfentanil AUC∞ ↑ 6-fold
Danish: I et uafhængigt, publiceret studie Alfentanil AUC0-∞ ↑ 6 gange
English: The compatibility of voriconazole with diluents other than described above or in section 6.2 is unknown.
Danish: Voriconazols forligelighed med andre fortyndingsmidler end dem, der er nævnt ovenfor eller i pkt.
English: subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life-threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below
Danish: • Allergiske hudreaktioner (sommetider svære), herunder hurtig hævelse (ødem) i huden, underhuden, slimhinder og vævet under slimhinden, kløende eller ømme pletter af tyk, rød hud med sølvfarvede hudskæl, irritation i hud og slimhinder, livstruende hudtilstand, der får store dele af overhuden, det yderste hudlag, til at løsnes fra hudlagene nedenunder
English: Although not studied clinically, voriconazole is likely to increase the plasma concentrations of statins that are metabolised by CYP3A4 and could lead to rhabdomyolysis.
Danish: Selvom det ikke er undersøgt klinisk er det sandsynligt, at voriconazol kan forøge plasmakoncentrationer af statiner, der metaboliseres af CYP3A4, og føre til rabdomyolyse.
English: Concomitant use of voriconazole and phenytoin should be avoided unless the benefit outweighs the risk.
Danish: Samtidig anvendelse af voriconazol og phenytoin bør undgås, medmindre fordelene opvejer ulemperne.
English: • Breathing difficulties.
Danish: • Vejrtrækningsbesvær
English: Musculoskelet al and connective tissue disorders back pain arthritis periostitis*
Danish: Knogler, led, muskler og bindevæv rygsmerter artritis periostitis*
English: Voriconazole Hikma is a single dose unpreserved sterile lyophile.
Danish: Voriconazole Hikma er et ukonserveret, sterilt, frysetørret lægemiddel til éngangsbrug.
English: Although not studied, voriconazole may increase the plasma concentrations of coumarins that may cause an increase in prothrombin time.
Danish: Selvom det ikke er undersøgt, er der mulighed for, at voriconazol kan øge plasmakoncentrationerne af coumariner, der kan medføre forlænget protrombintid.
English: Voriconazole Cmax ↓ 93% Voriconazole AUCτ ↓ 96%
Danish: Voriconazol Cmax ↓ 93 % Voriconazol AUCτ ↓ 96 %
English: Hepatotoxicity occurred at plasma exposures similar to those obtained at therapeutic doses in humans, in common with other antifungal agents.
Danish: Der ses, ligesom ved andre antimykotiske midler, hepatotoksicitet ved plasmaoptagelse svarende til den, der ses ved terapeutiske doser hos mennesker.
English: Although not studied, voriconazole is likely to increase the plasma concentrations of sulfonylureas and cause hypoglycaemia.
Danish: Selvom det ikke er undersøgt, er det sandsynligt, at voriconazol kan forøge plasmakoncentrationerne af sulfonylurinstof og forårsage hypoglykæmi.
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Hikma 200 mg powder for solution for infusion
Danish: LÆGEMIDLETS NAVN Voriconazole Hikma 200 mg pulver til infusionsvæske, opløsning
English: Prevention of fungal infections in high risk bone marrow transplant recipients This medicinal product should only be used under the supervision of a doctor.
Danish: Dette lægemiddel bør kun bruges under tilsyn af en læge.
English: • Hearing difficulties, ringing in the ears, vertigo
Danish: • Problemer med hørelsen, ringen for ørerne, fornemmelse af, at alting drejer rundt
English: Voriconazole Cmax ↑ 23% Voriconazole AUCτ ↓ 7%
Danish: Voriconazol Cmax ↑ 23 % Voriconazol AUCτ ↓ 7 %
English: Your doctor should monitor the function of your liver and kidneys by doing blood tests.
Danish: Deres læge vil tage blodprøver til vurdering af Deres lever- og nyrefunktion.
English: Voriconazole Cmax ↓ 4% Voriconazole AUCτ ↓ 32%
Danish: Voriconazol Cmax ↓ 4 % Voriconazol AUCτ ↓ 32 %
English: This will be given to you by intravenous infusion (into a vein) at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.
Danish: Voriconazole Hikma vil blive indgivet over 1-3 timer som intravenøs infusion (ind i en vene) med en maksimal infusionshastighed på 3 mg/kg/time.
English: Hepatobiliary disorders liver function test abnormal jaundice, jaundice cholestatic, hepatitis10
Danish: Lever og galdeveje abnorme leverfunktionsværdier icterus, kolestatisk icterus, hepatitis10
English: Voriconazole has been associated with cases of serious hepatic toxicity in patients with other serious underlying conditions.
Danish: Hos patienter med andre alvorlige tilgrundliggende sygdomme er voriconazol blevet forbundet med alvorlig levertoksicitet.
English: Concomitant use of voriconazole and phenytoin should be avoided unless the benefit outweighs the risk (see section 4.5).
Danish: Samtidig behandling med voriconazol og phenytoin bør undgås, medmindre fordelen opvejer risikoen (se pkt.
English: Undesirable effects reported in subjects receiving voriconazole:
Danish: Bivirkninger rapporteret hos personer, der fik voriconazol Systemorganklasse
English: Inflammation of the kidney, proteins in the urine, damage to the kidney
Danish: • Betændelsestilstand i nyrerne, proteiner i urinen, nyreskader
English: • Bullous photosensitivity
Danish: • Blæreformet eksem pga. lysfølsomhed
English: How to take Voriconazole Hikma
Danish: Sådan skal De tage Voriconazole Hikma
English: Renal and urinary disorders renal failure acute, haematuria renal tubular necrosis, proteinuria, nephritis
Danish: Nyrer og urinveje akut nyresvigt, hæmaturi nekrose i nyretubuli, proteinuri, nefritis
English: Voriconazole Cmax ↓ 69% Voriconazole AUCτ ↓ 78%
Danish: Voriconazol Cmax ↓ 69 % Voriconazol AUCτ ↓ 78 %
English: Dose for the first 24 hours (Loading Dose)
Danish: Dosis i de første 24 timer (initialdosis)
English: Concomitant use of voriconazole and rifabutin should be avoided unless the benefit outweighs the risk.
Danish: Samtidig administration af voriconazol og rifabutin skal undgås, medmindre fordelen ved behandling opvejer risikoen.