FrancophonIA/ELRC3.0 huggingface dataset:
English: Mechanisms of bacterial resistance that could decrease the antibacterial activity of meropenem/vaborbactam include porin mutations affecting outer membrane permeability and overexpression of efflux pumps.
Danish: De bakterielle resistensmekanismer, som kan reducere meropenems/vaborbactams antibakterielle aktivitet, omfatter porinmutationer, der påvirker den ydre membrans permeabilitet og effluxpumpernes overekspression.
English: • The following reactions may develop, alone or in combination, where Vaborem is given into a vein: reddened skin (erythema); hot, tender and swollen vein around the needle (phlebitis); a blood clot in the vein where the needle was put through your skin (infusion site thrombosis)
Danish: • Følgende reaktioner kan opstå alene eller samlet på det sted, hvor Vaborem gives i en blodåre: rødme på huden (erythem); varm, øm og hævet blodåre omkring kanylen (flebitis); en blodprop i blodåren, hvor kanylen er trængt igennem huden (trombose på infusionsstedet)
English: Common: (may affect up to 1 in 10 people)
Danish: Almindelige (kan ramme op til 1 ud af 10 personer):
English: • a medicine used to treat depression or anxiety called venlafaxine
Danish: • medicin til behandling af depression eller angst, som hedder venlafaxin
English: Table 2 shows the recommended dose adjustments for patients with a CrCl ≤39 ml/min.
Danish: Tabel 2 viser de anbefalede dosisjusteringer for patienter med en CrCl på ≤ 39 ml/min.
English: The elimination of meropenem by the kidneys resulted in high therapeutic concentrations in urine.
Danish: Nyrernes elimination af meropenem medførte høje terapeutiske koncentrationer i urin.
English: Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to meropenem/vaborbactam in vitro.
Danish: Der er i kliniske forsøg påvist en virkning mod nedenstående patogener, som var følsomme over for meropenem/vaborbactam in vitro.
English: Carcinogenicity studies have not been conducted with meropenem.
Danish: Der er ikke udført undersøgelser af meropenems karcinogenicitet.
English: • Reaction that occurs during or shortly after Vaborem is given that presents as a malaise (generally feeling unwell) possibly with any of the following: reduced blood pressure, nausea, vomiting, abdominal cramps, fever, flushing, rapid heart beats or difficulty to breathe, headache
Danish: • En reaktion, som opstår under eller kort tid efter behandling med Vaborem, der viser sig som ildebefindende (generel utilpashed), eventuelt samtidig med et eller flere af følgende: fald i blodtrykket, kvalme, opkastning, mavekramper, feber, rødme, hurtig hjerterytme eller vejrtrækningsbesvær, hovedpine
English: The mean renal clearance for vaborbactam was 10.5 L/h.
Danish: Den gennemsnitlige renale clearance af vaborbactam var 10,5 l/t.
English: Carcinogenicity studies have not been conducted with vaborbactam.
Danish: Der er ikke udført undersøgelser af vaborbactams karcinogenicitet.
English: The elimination of vaborbactam by the kidneys resulted in high concentrations in the urine.
Danish: Nyrernes elimination af vaborbactam medførte høje koncentrationer i urin.
English: What you need to know before you are given Vaborem
Danish: Det skal du vide, før du får Vaborem
English: • a medicine to treat issues with getting an erection in men or to treat high blood pressure in the lungs called sildenafil
Danish: • medicin, der bruges til behandling af rejsningsproblemer hos mænd eller til behandling af forhøjet blodtryk i lungerne, og som hedder sildenafil
English: The use of Vaborem to treat patients with complicated intra-abdominal infections is based on experience with meropenem alone and pharmacokinetic-pharmacodynamic analyses of meropenem/vaborbactam.
Danish: Anvendelse af Vaborem til behandling af patienter med komplicerede intraabdominale infektioner er baseret på erfaring med meropenem alene samt farmakokinetisk-farmakodynamiske analyser af meropenem/vaborbactam.
English: • a cholesterol-lowering medicine called lovastatin
Danish: • kolesterolsænkende medicin, der hedder lovastatin
English: • a medicine commonly used in medicines to treat a cough called dextromethorphan
Danish: • medicin, der ofte anvendes til behandling af hoste, og som hedder dextromethorphan
English: Gram-positive micro-organisms:
Danish: Grampositive mikroorganismer:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen.
English: • Haemolytic anaemia (a condition where red blood cells are damaged and reduced in number), which may make you feel tired and turn your skin and eyes yellow
Danish: • En tilstand, hvor de røde blodlegemer beskadiges og reduceres i antal (hæmolytisk anæmi), der medfører træthed og gulfarvning af hud og øjne
English: It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving Vaborem.
Danish: Det er vigtigt, at du fortæller det til din læge, inden du får Vaborem, hvis du ammer, eller du planlægger at amme.
English: Vaborbactam does not inhibit class D carbapenemases such as OXA-48 or class B metallo-β-lactamases such as NDM and VIM (see section 5.1).
Danish: Vaborbactam hæmmer ikke klasse D-carbapenemaser såsom OXA-48 eller klasse Bmetallo-β-lactamaser såsom NDM og VIM (se pkt.
English: Vaborem should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases (see sections 4.4 and 5.1).
Danish: Vaborem bør kun bruges til behandling af infektioner, der skyldes aerobe gramnegative organismer hos voksne patienter med begrænsede behandlingsmuligheder, efter konsultation ved en læge med relevant erfaring inden for behandling af infektionssygdomme (se pkt.
English: If this happens, do not take medicines that stop or slow bowel movement.
Danish: Lad være med at tage medicin, som standser eller forsinker afføringen, hvis det sker.
English: • Diarrhoea that keeps getting worse or does not go away, or stools that contains blood or mucusthis may happen during or after treatment with Vaborem is stopped.
Danish: • Diarré, der bliver værre eller ikke forsvinder, eller afføring, som indeholder blod eller slim.
English: Hepatic function monitoring
Danish: Monitorering af leverfunktion
English: LIST OF EXCIPIENTS Sodium carbonate.
Danish: LISTE OVER HJÆLPESTOFFER Natriumkarbonat.
English: Uncommon: (may affect up to 1 in 100 people)
Danish: Ikke almindelige (kan ramme op til 1 ud af 100 personer):
English: • of the bladder or kidneys (urinary tract infections)
Danish: • i blæren eller nyrerne (urinvejsinfektioner)
English: If necessary, the dose of meropenem/vaborbactam should be adjusted based on renal function (see section 4.2).
Danish: Dosis af meropenem/vaborbactam bør om nødvendigt justeres i henhold til nyrefunktion (se pkt.
English: • a medicine used to treat depression called desipramine
Danish: • medicin til behandling af depression, som hedder desipramin
English: There is no dose adjustment necessary (see section 4.2).
Danish: Der er ikke behov for justering af dosis (se pkt.
English: Pharmacokinetic studies with meropenem and vaborbactam in patients with renal impairment have shown that the plasma clearance of both meropenem and vaborbactam correlates with creatinine clearance.
Danish: Farmakokinetiske undersøgelser med meropenem og vaborbactam hos patienter med nedsat nyrefunktion har vist, at plasmaclearancen af både meropenem og vaborbactam hænger sammen med kreatininclearancen.
English: Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins, cephalosporins or monobactams).
Danish: Svær overfølsomhed (fx anafylaktisk reaktion, kraftig hudreaktion) over for en hvilken som helst anden type beta-lactam-antibiotika (fx penicilliner, cefalosporiner eller monobactamer).
English: Duration in accordance with the site of infection
Danish: Afhængigt af infektionssted
English: • Increase in the level of a substance in the blood called creatine phosphokinase that is a sign of possible damage to certain tissues such as your muscles and/or other organs - shown in blood tests
Danish: • Stigning i niveauet i blodet af et stof, der kaldes for kreatinfosfokinase, som er tegn på mulig beskadigelse af visse væv, for eksempel muskler og/eller andre organer (påvises i blodprøver)
English: • Less severe allergic reaction that may include redness, red bumps, flaking of the skin, itching,
Danish: • Mindre kraftig allergisk reaktion, der kan omfatte rødme, røde pletter, skæl i huden, kløe og generel utilpashed
English: • Enterobacter cloacae species complex
Danish: • Artskomplekset Enterobacter cloacae
English: The steady-state volumes of distribution of meropenem and vaborbactam in patients were 20.2 L and 18.6 L, respectively, following doses of 2 g meropenem/2 g vaborbactam infused over 3 hours every 8 hours, indicating that both compounds distribute into a volume of distribution consistent with the extracellular fluid compartment.
Danish: Meropenems og vaborbactams distributionsvolumener ved steady state i patienter var henholdsvis 20,2 l og 18,6 l efter doser på 2 g meropenem/2 g vaborbactam, der blev infunderet over 3 timer hver 8. time.
English: Alternatively, meropenem/vaborbactam should be discontinued (see section 4.5).
Danish: Alternativt bør meropenem/vaborbactam seponeres (se pkt.
English: • a medicine used to treat high blood pressure or chest pain called metoprolol
Danish: • medicin til behandling af forhøjet blodtryk eller brystsmerter, som hedder metoprolol
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 6 vials
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning 6 hætteglas
English: Recommended intravenous dose for patients with a creatinine clearance (CrCl) ≥40 ml/min1
Danish: Anbefalet intravenøs dosis for patienter med en kreatininclearance (CrCl) på ≥ 40 ml/min1
English: Vaborem is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1):
Danish: Vaborem er indiceret til behandling af følgende infektioner hos voksne (se pkt.
English: • Increase in the level of some types of substances in the blood called urea and creatinine that are signs that your kidneys are working less well - shown in blood tests
Danish: • Stigning i niveauet i blodet af visse typer stoffer, der kaldes for urea og kreatinin, som er tegn på, at nyrerne ikke fungerer så godt (påvises i blodprøver)
English: 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline) should be withdrawn from a 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection for each vial and reconstituted with the appropriate number of vials of meropenem/vaborbactam for the corresponding Vaborem dosage:
Danish: 20 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske (normalt saltvand) skal trækkes op af en 250 ml infusionspose med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske for hvert hætteglas og rekonstitueres med det relevante antal hætteglas med meropenem/vaborbactam til den tilsvarende dosering af Vaborem:
English: Recommended intravenous doses for patients with a CrCl ≤39 ml/min1
Danish: Anbefalede intravenøse doser for patienter med en CrCl på ≤ 39 ml/min1
English: For vaborbactam, the PK-PD index associated with antimicrobial activity is the ratio of free vaborbactam plasma AUC: meropenem/vaborbactam MIC.
Danish: For vaborbactam er det farmakokinetiske/farmakodynamiske indeks, der er forbundet med antimikrobiel aktivitet, forholdet mellem AUC for frit vaborbactam i plasma og MIC for meropenem/vaborbactam.
English: Frequency of adverse reactions by system organ class
Danish: Bivirkningshyppighed, inddelt efter systemorganklasse
English: • Staphylococcus epidermidis (methicillin susceptible isolates only)
Danish: • Staphylococcus epidermidis (kun methicillin-følsomme isolater)
English: • Bloating or a feeling of fullness in your abdomen
Danish: • Oppustethed eller en følelse af mæthed i maven
English: • Increase in the level of an enzyme called lactate dehydrogenase that may be a sign of damage to some of your body organs - shown in blood tests
Danish: • Stigning i niveauet af et enzym, der kaldes for laktatdehydrogenase, hvilket kan være tegn på beskadigelse af nogle af kroppens organer (påvises i blodprøver)
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift.
English: • A severe and very low white blood cell count - shown in blood tests
Danish: • Et kritisk, meget lavt antal hvide blodlegemer (påvises i blodprøver)
English: Marketing Authorisation Holder Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare
Danish: Indehaver af markedsføringstilladelsen Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare
English: • Increase in the number of platelets (a type of blood cell) - shown in blood tests
Danish: • Stigning i antallet af blodplader (en type blodceller) (påvises i blodprøver)
English: Each vial contains 1 g meropenem (as meropenem trihydrate) and 1 g vaborbactam.
Danish: Hvert hætteglas indeholder 1 g meropenem (som meropenemtrihydrat) og 1 vaborbactam.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains meropenem trihydrate equivalent to 1 g meropenem, and 1 g vaborbactam.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder meropenemtrihydrat svarende til 1 g meropenem og 1 g vaborbactam.
English: The inhibitory spectrum of vaborbactam includes class A carbapenemases (such as KPC) and Class C carbapenemases.
Danish: Vaborbactams hæmningsspektrum omfatter klasse A-carbapenemaser (såsom KPC) og klasse Ccarbapenemaser.
English: Alanine aminotransferase increased
Danish: Lever og galdeveje Forhøjet alaninaminotransferase
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for de)aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: Meropenem and vaborbactam can be removed by haemodialysis.
Danish: Meropenem og vaborbactam kan fjernes ved hæmodialyse.
English: Serious and occasionally fatal hypersensitivity reactions have been reported with meropenem and/or meropenem/vaborbactam (see sections 4.3 and 4.8).
Danish: Der er rapporteret om alvorlige og lejlighedsvis letale overfølsomhedsreaktioner ved behandling med meropenem og/eller meropenem/vaborbactam (se pkt.
English: The plasma protein binding of vaborbactam is approximately 33%.
Danish: Plasmaproteinbindingen af vaborbactam er cirka
English: • Increase in a type of white blood cell called eosinophils - shown in blood tests
Danish: • Stigning i en type hvide blodlegemer, der kaldes for eosinofiler (påvises i blodprøver)
English: • Staphylococcus aureus (methicillin susceptible isolates only)
Danish: • Staphylococcus aureus (kun methicillin-følsomme isolater)
English: Spectrum of activity of meropenem/vaborbactam
Danish: Meropenems/vaborbactams aktivitetsspektrum
English: Agranulocytosis Haemolytic anaemia
Danish: Agranulocytose Hæmolytisk anæmi
English: Vaborem is available in packs containing 6 vials.
Danish: Vaborem fås i pakninger med 6 hætteglas.
English: (≥1/10,000 to
Danish: Sjælden (≥1/10.000 til
English: • Increase in the level of a substance in the blood called bilirubin that is a sign of possible damage to your red blood cells or that your liver is working less well - shown in blood tests
Danish: • Stigning i niveauet i blodet af et stof, der kaldes for bilirubin, som er tegn på mulig beskadigelse af de røde blodlegemer eller tegn på, at leveren ikke fungerer så godt (påvises i blodprøver)
English: The colour of the diluted solution is clear to light yellow.
Danish: Den fortyndede opløsnings farve er klar til lysegul.
English: Vaborem may make you feel dizzy, sleepy and sluggish, give you a headache or tingling sensation (like “pins and needles”) or, in rare cases, cause a fit or seizure.
Danish: Vaborem kan gøre dig svimmel, søvnig og dvask, give dig hovedpine eller en stikkende og prikkende fornemmelse eller i sjældne tilfælde medføre kramper eller krampeanfald.
English: No dose adjustment based on age is required (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis på baggrund af alder (se pkt.
English: Bacteraemia, in association with, or suspected to be associated with, any of the infections listed above
Danish: Bakteriæmi i forbindelse med eller formodentlig forbundet med en eller flere af ovenstående infektioner
English: Infusion site erythema
Danish: Erythem på infusionsstedet
English: • Tremor or shaking
Danish: • Skælven eller rysten
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia The use of Vaborem to treat patients with hospital-acquired pneumonia, including ventilator-associated pneumonia, is based on experience with meropenem alone and pharmacokinetic-pharmacodynamic analyses for meropenem/vaborbactam.
Danish: Anvendelse af Vaborem til behandling af patienter med hospitalserhvervet pneumoni, herunder ventilatorassocieret pneumoni, er baseret på erfaring med meropenem alene samt farmakokinetiskfarmakodynamiske analyser af meropenem/vaborbactam.
English: Limited post-marketing experience with meropenem alone indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction.
Danish: Den begrænsede erfaring efter markedsføring med meropenem alene indikerer, at hvis der opstår bivirkninger efter overdosering, så svarer de til den bivirkningsprofil, der er beskrevet i pkt.
English: Before initiating therapy with Vaborem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
Danish: Der bør spørges grundigt ind til tidligere overfølsomhedsreaktioner over for beta-lactam-antibiotika inden initiering af behandling med Vaborem.
English: USE OF THE MEDICINAL PRODUCT
Danish: LÆGEMIDLETS NAVN
English: NAME OF THE MEDICINAL PRODUCT Vaborem 1 g/1 g powder for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Vaborem 1 g/1 g pulver til koncentrat til infusionsvæske, opløsning
English: Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Danish: Fortæl det straks til lægen eller sundhedspersonalet, hvis du bemærker en eller flere af følgende bivirkninger:
English: The final infusion concentration of meropenem and vaborbactam will be 2 mg/ml each.
Danish: Den endelige infusionskoncentration af meropenem og vaborbactam vil være 2 mg/ml hver.
English: Because a risk to the newborns/infants cannot be excluded, breastfeeding must be discontinued prior to initiating therapy.
Danish: Amning skal ophøre inden initiering af behandlingen, da en risiko for nyfødte/spædbørn ikke kan udelukkes.
English: • Increase in the amount of potassium or sugar - shown in blood tests
Danish: • Stigning i mængden af kalium eller sukker (påvises i blodprøver)
English: Blood creatine phosphokinase increased
Danish: Forhøjet kreatinphosphokinase i blodet
English: If you miss a dose of Vaborem If you think you have missed a dose, tell your doctor or nurse straight away.
Danish: Hvis en dosis Vaborem er sprunget over Fortæl det straks til lægen eller sundhedspersonalet, hvis du mener, at en dosis er sprunget over.
English: If you have kidney problems, your doctor may lower your dose.
Danish: Lægen vil muligvis sænke din dosis, hvis du har nyreproblemer.
English: (≥1/100 to <1/10)
Danish: Systemorganklasse Almindelig (≥1/100 til <1/10)
English: No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Danish: Der er ikke behov for justering af dosis til patienter med svækket leverfunktion (se pkt.
English: Hypersensitivity reactions
Danish: Anafylaktisk reaktion Overfølsomhed
English: Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4 and 5.1).
Danish: Vaborem er desuden indiceret til behandling af infektioner, der skyldes aerobe gramnegative organismer hos voksne med begrænsede behandlingsmuligheder (se pkt.
English: Infusion site reaction
Danish: Reaktion på infusionsstedet
English: 1 As calculated using the Cockcroft-Gault formula
Danish: 1 Beregnet med anvendelse af Cockcroft-Gault-formlen Se tabel 1 vedrørende anbefalet behandlingsvarighed
English: The final infusion concentration of meropenem and vaborbactam will be about 4 mg/ml each.
Danish: Den endelige infusionskoncentration af meropenem og vaborbactam vil være cirka 4 mg/ml hver.
English: The final infusion concentration of meropenem and vaborbactam will be about 8 mg/ml each.
Danish: Den endelige infusionskoncentration af meropenem og vaborbactam vil være cirka 8 mg/ml hver.
English: • Decrease in the number of white blood cells or some types of white blood cells called neutrophils and a decrease of platelets - shown in blood tests
Danish: • Fald i antallet af hvide blodlegemer eller nogle typer hvide blodlegemer, der kaldes for neutrofiler,
English: Table 1 shows the recommended intravenous dose for patients with a creatinine clearance (CrCl) ≥40 ml/min (see sections 4.4 and 5.1).
Danish: Tabel 1 viser den anbefalede intravenøse dosis for patienter med en kreatininclearance (CrCl) på ≥ 40 ml/min (se pkt.
English: Seizures have been reported during treatment with meropenem (see section 4.8).
Danish: Der er rapporteret om krampeanfald under behandling med meropenem (se pkt.
English: What Vaborem looks like and contents of the pack Vaborem is a white to light yellow powder for concentrate for solution for infusion supplied in a vial.
Danish: Vaborem er et hvidt til lysegult pulver til koncentrat til infusionsvæske, opløsning, der leveres i et hætteglas.
English: Infusion site phlebitis
Danish: Flebitis på infusionsstedet Pyreksi
English: • Itchy skin
Danish: • Kløende hud
English: 1, Avenue de la Gare, L-1611 Luxembourg
Danish: Menarini International O. L. S.A. 1, Avenue de la Gare L-1611, Luxembourg Luxembourg
English: The active substances are meropenem and vaborbactam.
Danish: Aktivt stof/aktive stoffer: meropenem og vaborbactam.
English: Vaborem 1 g/1 g powder for concentrate for solution for infusion meropenem/vaborbactam
Danish: Vaborem 1 g/1 g pulver til koncentrat til infusionsvæske, opløsning meropenem/vaborbactam
English: • Decrease in the amount of potassium or sugar- seen in blood tests
Danish: • Fald i mængden af kalium eller sukker (påvises i blodprøver)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains meropenem trihydrate equivalent to 1 g meropenem and 1 g vaborbactam.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder meropenemtrihydrat svarende til 1 g meropenem og 1 g vaborbactam.
English: What Vaborem contains
Danish: Vaborem indeholder:
English: Meropenem/vaborbactam may cause headache, paraesthesia, lethargy and dizziness (see section 4.8).
Danish: Meropenem/vaborbactam kan forårsage hovedpine, paræstesi, letargi og svimmelhed (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 g meropenem/1 g vaborbactam LIST OF EXCIPIENTS Sodium carbonate
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 g meropenem/1 g vaborbactam
English: NAME OF THE MEDICINAL PRODUCT Vaborem 1 g/1 g powder for concentrate meropenem/vaborbactam
Danish: Vaborem 1 g/1 g pulver til koncentrat meropenem/vaborbactam
English: If administration of Vaborem is necessary, supplemental anticonvulsant therapy should be considered (see section 4.5).
Danish: Supplerende behandling med antikonvulsiva bør overvejes, hvis administration af Vaborem er nødvendig (se pkt.
English: Blood lactate dehydrogenase increased
Danish: Forhøjet laktatdehydrogenase i blodet
English: Treatment may continue up to 14 days
Danish: 1 Beregnet med anvendelse af Cockcroft-Gault-formlen Behandlingen kan fortsætte i op til 14 dage