FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Dosisjusteringer i tilfælde af samtidig administration Phenytoin kan administreres sammen med voriconazol, hvis vedligeholdelsesdosis af voriconazol øges fra 200 mg til 400 mg oralt to gange dagligt (fra 100 mg til 200 mg oralt to gange dagligt hos patienter, der vejer mindre end 40 kg), se pkt.
English: 300 mg QD (coadministered with voriconazole 350 mg BID)
Danish: 300 mg QD (administeret sammen med voriconazol 350 mg BID)
English: Safety and effectiveness in paediatric subjects below the age of two years has not been established (see sections 4.8 and 5.1).
Danish: Sikkerhed og effekt hos børn under 2 år er ikke undersøgt (se pkt.
English: Cleaning and storing the syringe:
Danish: Rensning og opbevaring af doseringssprøjten
English: Voriconazole Cmax  93% Voriconazole AUC  96%
Danish: Voriconazol Cmax  93% Voriconazol AUC  96%
English: 200 mg (5 ml) twice a day
Danish: 200 mg (5 ml) 2 gange dagligt
English: Hearing difficulties, ringing in the ears, vertigo
Danish: • Problemer med hørelsen, ringen for ørerne, fornemmelse af, at alting drejer rundt
English: Remove child-resistant cap. Press bottle adaptor into the neck of the bottle.
Danish: Tryk flaskeadaptoren ned i flaskehalsen.
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: VFEND 200 mg film-coated tablets are supplied as white to off-white capsule shaped film-coated tablets with Pfizer marked on one side and VOR200 on the reverse.
Danish: VFEND 200 mg filmovertrukne tabletter er hvide til råhvide, kapselformede filmovertrukne tabletter, som er præget med ”Pfizer” på den ene side og ”VOR200” på den anden side.
English: (Maintenance Dose)
Danish: ≥ R (resistent)
English: Each tablet contains 200 mg voriconazole.
Danish: Hver tablet indeholder 200 mg voriconazol.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Er De i tvivl så spørg lægen eller apoteket.
English: VFEND 50 mg film-coated tablets are supplied as white to off-white round film-coated tablets with Pfizer marked on one side and VOR50 on the reverse.
Danish: VFEND 50 mg filmovertrukne tabletter er hvide til råhvide, runde filmovertrukne tabletter, som er præget med ”Pfizer” på den ene side og ”VOR50” på den anden side.
English: Voriconazole Cmax  69% Voriconazole AUC  78%
Danish: Voriconazol Cmax  69% Voriconazol AUC  78%
English: 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).
Danish: I et oralt flerdosisstudie med raske, ældre mænd (65 år) var Cmax og AUC henholdsvis 61% og 86% højere, end hos raske, unge mænd (18-45 år).
English: radiographic/bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31% of patients treated with comparator.
Danish: Der sås tilfredstillende globalt respons (fuldstændig 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.
English: Nervous system disorders headache convulsion, syncope, tremor, hypertonia paraesthesia, somnolence, dizziness brain oedema, encephalopathy extrapyramidal disorder neuropathy peripheral, ataxia, hypoaesthesia, dysgeusia hepatic encephalopathy, Guillain-Barre syndrome, nystagmus
Danish: Nervesystemet hovedpine kramper, synkope, tremor, hypertoni paræstesi, søvnighed, svimmelhed hjerneødem, encefalopati ekstrapyramidal lidelse
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 sulfonylurinstoffer og forårsage hypoglykæmi.
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, swinging vision, seeing sparks, visual aura, visual acuity reduced, visual brightness, loss of part of the usual field of vision, spots before the eyes)
Danish: • Nedsat syn (ændring i synet såsom sløret syn, ændringer i farvesyn, unormal manglende tolerance ved synsopfattelse af lys, farveblindhed, øjensygdom, lyscirkler, natteblindhed,
English: If you take more tablets than prescribed (or if someone else takes your tablets) you must seek medical advice or go to the nearest hospital casualty department immediately.
Danish: Kontakt lægen eller skadestuen, hvis De har taget flere tabletter, end De har fået foreskrevet (eller hvis andre tager Deres tabletter).
English: Keeping the vial upright, empty contents of the syringe into the vial.
Danish: Hold hætteglasset lodret, mens indholdet tømmes i hætteglasset.
English: If you take more suspension than prescribed (or if someone else takes your suspension) you must seek medical advice or go to the nearest hospital casualty department immediately.
Danish: Kontakt lægen eller skadestuen, hvis De har taget mere suspension, end De har fået foreskrevet (eller hvis andre tager Deres suspension).
English: 4 Gently invert the vial.
Danish: 4 Hætteglasset vendes forsigtigt på hovedet.
English: Blister pack for 50 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
Danish: Blisterpakning for 50 mg filmovertrukne tabletter - pakning med 2, 10, 14, 20, 28, 30, 50, 56,100 stk.
English: Voriconazole Cmax  34% Voriconazole AUC  39%
Danish: Voriconazol Cmax  34% Voriconazol AUC  39%
English: There have been rare cases of torsades de pointes in patients taking voriconazole who had risk factors, such as history of cardiotoxic chemotherapy, cardiomyopathy, hypokalaemia and concomitant medicinal products that may have been contributory.
Danish: Hos patienter med risikofaktorer, som f.eks. kardiotoksisk kemoterapi i anamnesen, kardiomyopati, hypokaliæmi og samtidig administration af medicin, der kan have været medvirkende årsag, er der set sjældne tilfælde af torsades de pointes, hvis de er i behandling med voriconazol.
English: Dose for the first 24 hours (Loading Dose)
Danish: Dosis i de første 24 timer (Initialdosis)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Danish: KRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ INDRE EMBALLAGER
English: Voriconazole Cmax  49% Voriconazole AUC  69%
Danish: Voriconazol Cmax  49% Voriconazol AUC  69%
English: Voriconazole Cmax  4% Voriconazole AUC  32%
Danish: Voriconazol Cmax  4% Voriconazol AUC  32%
English: 8, drug reaction with eosinophilia and systemic symptoms (DRESS) angioedema, actinic keratosis*, pseudoporphyria , erythema multiforme, psoriasis, drug eruption cutaneous lupus erythemato sus*, ephelides*, lentigo*
Danish: Stevens-Johnsons syndrom fototoksicitet, purpura, urticaria, allergisk dermatitis, papuløst hududslæt, makuløst hududslæt, eksem toksisk epidermal nekrolyse lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS) angioødem, aktinisk keratose*, pseudoporfyri, erythema multiforme, psoriasis, medicinudslæt kutan lupus erythematosus*, efelider*, lentigo*
English: -The other ingredient is sulfobutylether beta cyclodextrin sodium.
Danish: • Øvrigt indholdsstof: sulfobutylether-beta-cyclodextrinnatrium.
English: Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)
Danish: • Lavt blodtryk, betændelsestilstand i en vene (som kan forbindes med dannelse af blodpropper)
English: Compared to efavirenz 600 mg QD, Efavirenz Cmax ↔ Efavirenz AUC  17%
Danish: Efavirenz Cmax ↔ Efavirenz AUC  17%
English: Reactions during the infusion have occurred uncommonly with VFEND (including flushing, fever, sweating, increased heart rate and shortness of breath).
Danish: Reaktioner (omfattende rødmen, feber, svedtendens, hurtig puls (øget hjerterytme) og kortåndethed) er set af og til under infusion med VFEND.
English: 1 sterile, single use vial adapter.
Danish: 1 steril hætteglasadapter til engangsbrug.
English: Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID
Danish: Efavirenz 400 mg QD, administreret sammen med voriconazol 200 mg BID
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: Solvent for VFEND powder for solution for infusion Sodium Chloride 0.9% in Water for Injections Intravenous use
Danish: Solvens til VFEND pulver til infusionsvæske, opløsning Natriumchlorid 9 mg/ml (0,9%) i vand til injektionsvæsker Kun til i.v.-infusion
English: Voriconazole Cmax  18% Voriconazole AUC  23%
Danish: Voriconazol Cmax  18% Voriconazol AUC  23%
English: Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole.
Danish: Hvis voriconazol anvendes sekventielt efter fluconazol anbefales det, at der monitoreres for voriconazolrelaterede bivirkninger.
English: Voriconazole Cmax  23% Voriconazole AUC  7%
Danish: Voriconazol Cmax  23% Voriconazol AUC  7%
English: Instructions to constitute the suspension:
Danish: Vejledning for sammenblanding af suspensionen
English: Single use vial Infuse at a maximum rate of 3 mg/kg per hour.
Danish: Hætteglas til engangsbrug Maksimal infusionshastighed er 3 mg/kg/time.
English: Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID
Danish: Efavirenz 300 mg QD, administreret sammen med voriconazol 400 mg BID
English: 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 voriconazole (see section 5.2).
Danish: Hos patienter med mild til moderat levercirrose (Child-Pugh klasse A og B), der får voriconazol, anbefales standard initialdosis, mens vedligeholdelsesdosis halveres (se pkt.
English: VFEND 200 mg powder for solution for infusion:
Danish: VFEND 200 mg pulver til infusionsvæske, opløsning:
English: Long-Acting Opiates [CYP3A4 substrates]
Danish: Langtidsvirkende opiater [CYP3A4-substrater]
English: • The other ingredients are lactose monohydrate, pregelatinised starch, croscarmellose sodium, povidone and magnesium stearate which make up the tablet core and hypromellose, titanium dioxide (E171), lactose monohydrate and glycerol triacetate which make up the film-coat.
Danish: • Øvrige indholdsstoffer: Tabletkerne: Lactosemonohydrat, pregelatineret stivelse, croscarmellosenatrium, povidon og magnesiumstearat.
English: Tablets Patients 40 kg and above Patients less than 40 kg
Danish: Tabletter Patienter 40 kg og derover
English: 1 sterile, single use syringe.
Danish: 1 steril engangssprøjte.
English: VFEND contains the active substance voriconazole.
Danish: VFEND indeholder det aktive stof voriconazol og er et middel mod svampeinfektioner.
English: Long-acting opiates (CYP3A4 substrate)
Danish: Langtidsvirkende opiater (CYP3A4-substrat)
English: Step 1 1a Peel back the seal from the vial adaptor.
Danish: 1a Fjern forseglingen fra hætteglasadapteren.
English: 300 mg QD (coadministered with voriconazole 400 mg BID)
Danish: 300 mg QD (administreret sammen med voriconazol 400 mg BID)
English: Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg])
Danish: Dosisjustering (børn (2- <12 år) og unge med lav legemsvægt (12-14 år og <50 kg)) Ved utilstrækkeligt behandlingsrespons kan dosis øges i trin på 1 mg/kg.
English: Although not studied, voriconazole is likely to increase the plasma concentrations of ergot alkaloids and lead to ergotism.
Danish: Selvom det ikke er undersøgt er det sandsynligt, at voriconazol øger plasmakoncentrationen af sekalergot alkaloider og medfører ergotisme.
English: Uncommon: may affect up to 1 in 100 people
Danish: Almindelige: Det forekommer hos mellem 1 og 10 ud af 100 patienter
English: Fill the measuring cup to the top of the marked line then pour the water into the bottle.
Danish: Fyld målebægeret op til markeringen.
English: Decreased sensitivity to touch
Danish: • Nedsat berøringsfølelse
English: Although not studied, voriconazole is likely to increase the plasma concentrations of vinca alkaloids and lead to neurotoxicity.
Danish: Selvom det ikke er undersøgt er det sandsynligt, at voriconazol kan forøge plasmakoncentrationerne af vinkaalkaloider og forårsage neurotoksicitet.
English: Icepharm hf., Sími: + 354 540 8000
Danish: Simí: + 354 540 8000
English: VFEND 200 mg powder and solvent for solution for infusion:
Danish: VFEND 200 mg pulver og solvens til infusionsvæske, opløsning:
English: PC: SN:
Danish: SN: {nummer} [serienummer]
English: Powder for oral suspension White to off-white powder
Danish: Hvidt til råhvidt pulver
English: 6 mg/kg every 12 hours
Danish: 6 mg/kg hver 12. time 400 mg hver 12. time
English: Cardiovascular
Danish: Infusionspose
English: VFEND 50 mg film-coated tablets White to off-white, round tablet, debossed “Pfizer” on one side and “VOR50”on the reverse.
Danish: Hvide til råhvide, runde tabletter, med ”Pfizer” præget på den ene side og ”VOR50” på den anden side.
English: VFEND is a single dose unpreserved sterile lyophile.
Danish: VFEND er et ukonserveret, sterilt, frysetørret lægemiddel til éngangsbrug.
English: VFEND 200 mg powder for solution for infusion
Danish: VFEND 200 mg pulver til infusionsvæske, opløsning
English: Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, inflammation of the gastrointestinal tract causing antibiotic associated diarrhoea, inflammation of the lymphatic vessels Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organ
Danish: • Influenzalignende symptomer, irritation og betændelse i mave-tarm-kanalen, bBetændelse i mave-tarm-kanalen, der forårsager diarré i forbindelse med antibiotika, betændelse i lymfekar
English: 50 ml infusion bag containing 0.9% of sodium chloride.
Danish: 1 infusionspose indeholder 50 ml 9 mg/ml (0,9%) natriumchloridopløsning.
English: VFEND 200 mg film-coated tablets White to off-white, capsule-shaped tablet, debossed “Pfizer” on one side and “VOR200”on the reverse.
Danish: Hvide til råhvide, kapselformede tabletter, med ”Pfizer” præget på den ene side og ”VOR200” på den anden side.
English: Excipient with known effect Each vial contains 217.6 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder 217,6 mg natrium.
English: Concomitant use of voriconazole and rifabutin should be avoided unless the benefit outweighs the risk.
Danish: 4.3) Samtidig administration af voriconazol og rifabutin skal undgås, medmindre fordelen ved behandling udvejer risikoen.
English: Double vision, serious conditions of the eye including: pain and inflammation of the eyes and eyelids, abnormal eye movement, damage to the optic nerve resulting in vision impairment, optic disc swelling
Danish: • Dobbeltsyn, alvorlige øjentilstande, herunder smerter og betændelsestilstand i øjne og øjenlåg,
English: Constipation, indigestion, inflammation of the lips Jaundice, inflammation of the liver and liver injury Skin rashes which may lead to severe blistering and peeling of the skin characterized by a flat, red area on the skin that is covered with small confluent bumps, redness of the skin
Danish: • Hududslæt, der kan medføre udbredt blæredannelse og afskalning af huden, og som er kendetegnet ved et fladt, rødt område på huden, der er dækket af små sammenflydende ujævnheder, hudrødme
English: Voriconazole was compared to itraconazole as primary prophylaxis in an open-label, comparative, multicenter study of adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI.
Danish: Primær profylakse af invasive svampeinfektioner - virkning hos HSC-transplanterede patienter uden forudgående påvist eller sandsynlig invasiv svampeinfektion Voriconazol blev sammenlignet med itraconazol som primær profylakse i et åbent, komparativt multicenterstudie hos voksne og unge, der havde fået allogen HSCT, uden forudgående påvist eller sandsynlig invasiv svampeinfektion.
English: Short-acting Opiates [CYP3A4 substrates]
Danish: Korttidsvirkende opiater [CYP3A4-substrater]
English: Deterioration of brain function that is a serious complication of liver disease Loss of most fibers in the optic nerve, clouding of the cornea, involuntary movement of the eye Bullous photosensitivity
Danish: • Tab af de fleste fibre i synsnerven, uklar hornhinde, ufrivillige øjenbevægelser
English: NN:
Danish: VFEND indeholder:
English: Short-acting opiates (CYP3A4 substrate)
Danish: Korttidsvirkende opiater (CYP3A4-substrat)
English: Constipation, indigestion, inflammation of the lips Jaundice, inflammation of the liver and liver injury Skin rashes which may lead to severe blistering and peeling of the skin characterized by a flat, red area on the skin that is covered with small confluent bumps, redness of the skin Itchiness
Danish: 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: Pfizer România S.R.L Tel: +40 (0)21 207 28 00
Danish: Tel: +40 (0)21 207 28 00
English: If not used immediately, in-use storage times and conditions of the reconstituted vial 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.
Danish: Hvis produktet ikke anvendes umiddelbart efter rekonstitution, er opbevaringstid og -betingelser brugerens eget ansvar og må normalt ikke overstige 24 timer ved 2°C-8°C, medmindre rekonstitution er foretaget under kontrollerede og validerede aseptiske forhold.
English: What VFEND looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Rare: may affect up to 1 in 1000 people
Danish: Sjældne:Det forekommer hos mellem 1 og 10 ud af 10.000 patienter
English: Stomach pains
Danish: • Mavesmerter
English: 400 mg (10 ml) every 12 200 mg (5 ml) every 12
Danish: 6 mg/kg hver 12. time 400 mg (10 ml) hver 12. time
English: If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking VFEND.
Danish: Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: • Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, De vil vide.
English: Your doctor should monitor the function of your liver and kidney by doing blood tests.
Danish: Deres læge vil tage blodprøver til vurdering af Deres lever- og nyrefunktion.
English: Vial contains 200 mg of voriconazole.
Danish: 1 hætteglas indeholder 200 mg voriconazol.
English: VFEND 200 mg powder and solvent for solution for infusion
Danish: VFEND 200 mg pulver og solvens til infusionsvæske, opløsning
English: Blood products and short-term infusion of concentrated solutions of electrolytes: Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia 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: SLOWLY push down the plunger of the oral syringe.
Danish: Tryk stemplet i doseringssprøjten langsomt ned.
English: What VFEND looks like and contents of the pack VFEND is presented in single use glass vials as a powder for solution for infusion.
Danish: VFEND findes i hætteglas af glas som pulver til infusionsvæske, opløsning beregnet til engangsbrug.
English: Replace the cap on the bottle.
Danish: Hæld vandet i flasken.
English: VFEND 200 mg powder and solvent for solution for infusion voriconazole
Danish: VFEND 200 mg pulver og solvens til infusionsvæske, opløsning Voriconazol
English: VFEND 200 mg powder and solvent for solution for infusion Voriconazole
Danish: VFEND 200 mg pulver og solvens til infusionsvæske, opløsning voriconazol
English: VFEND 200 mg powder for solution for infusion voriconazole
Danish: VFEND 200 mg pulver til infusionsvæske, opløsning voriconazol
English: VFEND 200 mg powder for solution for infusion Voriconazole
Danish: VFEND 200 mg pulver til infusionsvæske, opløsning Voriconazol
English: What VFEND is and what it is used for What you need to know before you take VFEND How to use VFEND
Danish: Det skal De vide, før De begynder at bruge VFEND Sådan bliver De behandlet med VFEND Bivirkninger
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking VFEND.
Danish: Kontakt lægen før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Coadministration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations.
Danish: Everolimus (CYP3A4-substrat, P-glykoprotein-(P-gp) substrat) Samtidig administration af voriconazol og everolimus anbefales ikke, fordi voriconazol antages at øge koncentrationen af everolimus signifikant.
English: 4 mg/kg twice daily 200 mg twice daily 100 mg twice daily
Danish: 6 mg/kg hver 12. time 400 mg hver 12. time 200 mg hver 12. time
English: Powder: store at in a refrigerator before constitution.
Danish: Pulver: Opbevares ved 2°C-8°C (i køleskab) før sammenblanding.
English: (Child-Pugh C) (see sections 4.2 and 4.4).
Danish: 4.2 og 4.4).
English: Breakthrough IFI - Day 180 1 (1.0%)
Danish: Gennembrud invasiv svampeinfektion - dag 180
English: What VFEND is and what it is used for What you need to know before you take VFEND How to take VFEND
Danish: Det skal De vide, før De begynder at tage VFEND Sådan skal De tage VFEND Bivirkninger
English: Do not remove casing.
Danish: Tag ikke adapteren ud af omslaget.
English: What VFEND looks like and contents of the pack VFEND powder and solvent for solution for infusion is presented as an administration kit containing:
Danish: VFEND pulver og solvens til infusionsvæske, opløsning leveres i et infusionssæt, der indeholder:
English: Label on the overwrap
Danish: Etiket til folieomslag
English: 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 (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Anvendelse af andre opbevaringsbetingelser er på brugerens eget ansvar og må ikke overstige 24 timer ved 2°C-8°C (køleskab), medmindre rekonstituering er foretaget under kontrollerede og validerede aseptiske forhold.
English: How to use VFEND
Danish: Hvis De holder op med at bruge VFEND
English: 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.
Danish: Anvendelse af andre opbevaringstider og -betingelser er på brugerens eget ansvar og må ikke overstige 24 timer ved 2°C til 8°C, medmindre rekonstituering er foretaget under kontrollerede og validerede aseptiske forhold.