FrancophonIA/ELRC3.0 huggingface dataset:
English: Draw air into the syringe by pulling the plunger to the volume of water added.
Danish: Træk luft ind i sprøjten ved at trække stemplet til den mængde vand, der er tilsat.
English: Required dose (IU) = body weight (kg) x desired factor X rise (IU/dL) x 0.5
Danish: Nødvendig dosis (IE) = legemsvægt (kg) x den ønskede faktor X-stigning (IE/dl) x 0,5
English: 500 IU human coagulation factor X, approximately 100 IU/mL
Danish: 500 IE human koagulationsfaktor X, ca. 100 IE/ml
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs http://www.ema.europa.eu hjemmeside og på Sundhedsstyrelsens hjemmeside http://www.sst.dk/
English: Contents of the pack and other information What Coagadex contains
Danish: Pakningsstørrelse og yderligere oplysninger Coagadex indeholder:
English: Therefore, Coagadex should be used during breast-feeding only if clearly indicated.
Danish: Coagadex må derfor kun anvendes under amning, hvis det er klart indiceret.
English: 250 IU human coagulation factor X, approximately 100 IU/mL
Danish: 250 IE human koagulationsfaktor X, ca. 100 IE/ml
English: Step 5: Separate the empty solvent vial and blue part from the clear part by unscrewing anti-clockwise.
Danish: Trin 5: Adskil det tomme hætteglas med opløsningen og den blå del fra den klare del ved at skrue mod uret.
English: Powder vial: 250 IU or 500 IU of human coagulation factor X in a type I glass vial stoppered with a halobutyl rubber stopper, oversealed with a snap-off polypropylene cap and aluminium lacquered skirt.
Danish: Pulverhætteglas: 250 IE eller 500 IE human koagulationsfaktor X i et type I glashætteglas med en gummiprop (halobutyl), forseglet med snap-off hætte af polypropylen og aluminiumslakeret skørt.
English: Disconnect the filled syringe from the device.
Danish: Fjern den fyldte sprøjte fra enheden.
English: Powder and solvent for solution for injection.
Danish: Pulver og opløsningsmiddel til injektionsvæske.
English: Solvent vial: 2.5 mL or 5 mL solution in a type I glass vial sealed with a halobutyl rubber stopper and an overseal.
Danish: 1 hætteglas med opløsningsmiddel: 2,5 ml eller 5 mlopløsningsmiddel i et type 1 glashætteglas forseglet med en gummiprop (halobutyl) og et oversegl.
English: Quantity of Coagadex
Danish: Mængde af Coagadex
English: Coagadex contains approximately 100 IU/mL human coagulation factor X after reconstitution with 2.5 mL (250 IU) or 5 mL (500 IU) sterilised water for injections.
Danish: Hvert hætteglas indeholder nominelt 250 IE eller 500 IE human koagulationsfaktor X. Coagadex indeholder ca. 100 IE/ml human koagulationsfaktor X efter restituering med 2,5 ml (250 IE) eller 5 ml (500 IE) steriliseret vand til injektionsvæske Fremstillet af plasma fra humane donorer.
English: The mean dose per infusion and total dose of Coagadex were 25.4 IU/kg and 30.4 IU/kg, respectively.
Danish: Den gennemsnitlige dosis pr. infusion og samlede dosis Coagadex var hhv. 25,4 IE/kg og 30,4 IE/kg.
English: use after reconstitution.
Danish: Til intravenøs brug after restituering.
English: Keep container in the outer carton in order to protect it from light.
Danish: Opbevar beholderen i den ydre karton for at beskytte mod lys.
English: • The solvent will be pulled into the powder vial by the vacuum contained within it.
Danish: • Opløsningsmidlet vil blive trukket ind i pulverhætteglasset vha. vakuummet heri.
English: For major surgery, a median of 13 infusions (range 2 to 15 infusions) and a median cumulative dose of 181 IU/kg (range 45 to 210 IU/kg) were required to maintain haemostasis.
Danish: Til større operationer krævedes gennemsnitligt 13 infusioner (mellem 2 og 15 infusioner) og der krævedes en gennemsnitlig kumulativ dosis på 181 IE/kg (mellem 45 og 210 IE/kg) for at opretholde hæmostase.
English: For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity or dental appointments: 30 IU/kg Coagadex should be injected and repeated as required.
Danish: Til sekundær profylakse mod gentagen blødning eller kortvarig profylakse før den forventede fysiske aktivitet eller tandlægebesøg: 30 IE/kg Coagadex skal injiceres og gentages efter behov.
English: BPL Bioproducts Laboratory GmbH 63263 Neu-Isenburg Germany
Danish: BPL Bioproducts Laboratory GmbH 63263 Neu-Isenburg Tyskland
English: The following adverse reactions have been reported in clinical studies involving 27 patients treated with
Danish: Følgende bivirkninger er blevet indberettet i kliniske forsøg med 27 patienter, som blev behandlet med Coagadex.
English: BPL Bioproducts Laboratory GmbH Dornhofstraße, 63263 Neu-Isenburg Germany
Danish: BPL Bioproducts Laboratory GmbH Dornhofstraße,63263 Neu-Isenburg Tyskland
English: Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.6 OR Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 1.7
Danish: Dosis (IE) = legemsvægt (kg) x den ønskede faktor X-stigning (IE/dl eller % af det normale) x 0,6 ELLER Stigning i faktor X-niveau (IE/dl eller % af det normale) = [total dosis (IE)/legemsvægt (kg)] x 1,7
English: For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity or dental appointments: 25 IU/kg Coagadex should be injected and repeated as required.
Danish: For sekundær profylakse mod fornyet blødning eller kortvarig profylakse før forventet fysisk aktivitet eller tandlægebesøg: Der skal injiceres 25 IE/kg Coagadex og gentag efter behov.
English: Routine prophylaxis of bleeding episodes
Danish: Rutinemæssig profylakse af blødningsepisoder
English: A peak factor X level of 90% of normal is required in a 70 kg patient.
Danish: Der kræves et peak faktor X-niveau på 90 % af det normale for en patient på 70 kg. I denne situation ville den passende dosis være:
English: Transfer Device (Mix2Vial).
Danish: Overførselsenhed Mix2Vial.
English: • Peel back the top of the transfer device package but leave the device in the package.
Danish: • Pil toppen af pakken af med overførselsenheden men lad enheden blive i pakken.
English: • Remove the cap from the powder vial and clean the top of the stopper with an alcohol swab.
Danish: • Fjern hætten fra hætteglasset med pulver og rengør toppen af proppen med en spritserviet.
English: Elderly No dose adjustment is necessary.
Danish: Kræver ingen dosisjustering.
English: Keep the vial in the outer carton to protect from light.
Danish: Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: Step 3: Turn the solvent vial upside down with the transfer device still attached.
Danish: Trin 3: Vend hætteglasset med opløsningsmidlet på hovedet, mens overførselsenheden stadig er fastgjort.
English: • Separate the empty solvent vial and blue part from the clear part by unscrewing anti-clockwise.
Danish: • Adskil det tomme hætteglas med opløsningsmiddel og den blå del fra den klare del ved at skrue af mod uret.
English: Connect the syringe to the clear part of the transfer device and push the air into the vial.
Danish: Sæt sprøjten fast på den klare del af overførselsenheden og skub luften ind i hætteglasset.
English: Solvent vial containing clear colourless liquid.
Danish: Hætteglas med opløsningsmidlet indeholder farveløs væske.
English: If you stop using Coagadex
Danish: Hvis du holder op med at tage Coagadex
English: Step 5
Danish: Trin 5
English: • Disconnect the filled syringe from the device.
Danish: • Fjern den fyldte sprøjte fra enheden.
English: For minor surgery, a median of 2.5 infusions (range 1 to 4 infusions) and a median cumulative dose of 89 IU/kg (range 51 to 127 IU/kg) were used to maintain haemostasis.
Danish: Til mindre operationer krævedes gennemsnitligt 2,5 infusioner (mellem 1 og 4 infusioner) og der krævedes en gennemsnitlig kumulativ dosis på 89 IE/kg (mellem 51 og 127 IE/kg) for at opretholde hæmostase.
English: If you forget to use Coagadex
Danish: Hvis du har glemt at tage Coagadex
English: Peel back the top of the transfer device package but leave the device in the package.
Danish: Fjern toppen af pakken med overførselsenheden, men lad enheden blive i pakken.
English: No pharmacokinetic studies have been conducted but there is no anticipated effect of age on the pharmacokinetic profile of Coagadex.
Danish: Ingen farmakokinetiske undersøgelser er blevet gennemført, men der er ingen forventet effekt på alder på Coagadex' farmakokinetiske profil.
English: Transmissible Agents
Danish: Overførbare stoffer
English: • Connect the syringe to the clear part of the transfer device and push the air in the syringe into the vial.
Danish: • Tilslut sprøjten til den klare del af overførselsenheden og skub luften fra sprøjten ind i hætteglasset.
English: Step 1: Remove the cap from the powder vial and clean the top of the stopper with an alcohol swab.
Danish: Trin 1: Fjern låget fra pulverhætteglasset og rengør toppen af proppen med en spritserviet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 250 IU
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED 250 IE
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on an infection cannot be totally excluded.
Danish: Trods disse foranstaltninger, kan muligheden for overførsel af en infektion ikke helt udelukkes, når lægemidler, som er fremstillet af humant blod eller plasma, administreres.
English: Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.5 OR Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 2
Danish: Dosis (IE) = legemsvægt (kg) x den ønskede faktor X-stigning (IE/dl eller % af det normale) x ELLER Stigning i faktor X-niveau (IE/dl eller % af det normale) = [total dosis (IE)/legemsvægt (kg)] x 2
English: Step 4: The solvent will be pulled into the powder vial by the vacuum contained within it.
Danish: Trin 4: Opløsningsmidlet vil blive trukket ind i pulverhætteglasset vha.
English: Control of Bleeding Episodes
Danish: Kontrol af blødningsepisoder
English: No pharmacokinetic studies have been conducted but there is no anticipated effect of gender or renal function on the pharmacokinetic profile of Coagadex.
Danish: Ingen farmakokinetiske undersøgelser er blevet gennemført, men der er ingen forventet effekt af køn eller leverfunktion på Coagadex' farmakokinetiske profil.
English: - The active substance is human coagulation factor X. One vial contains nominally 250 IU or 500 IU
Danish: - Aktivt stof/aktive stoffer: human koagulationsfaktor X. Et hætteglas indeholder normalt 250 IE
English: Water for injections
Danish: Opløsningsmiddel Vand til injektionsvæske
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 500 IU
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED 500 IE
English: Volume of solvent
Danish: Mængde opløsningsmiddel
English: - Solvent: water for injections.
Danish: - Opløsningsmiddel: vand til injektionsvæske.
English: Step 2: Place the blue end of the transfer device on the solvent vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Danish: Trin 2: Placér den blå ende af overførselsenheden på hætteglasset med opløsningsmidlet og skub lige ned, indtil spidsen trænger igennem gummiproppen og klikker på plads.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Danish: På trods af dette kan muligheden for overførsel af smitstoffer ikke helt udelukkes, når der administreres lægemidler fremstillet af humant blod eller plasma.
English: Human coagulation factor X is largely retained within the vascular compartment: mean apparent volume of distribution (Vss) was 56.3 (24.0) mL/kg.
Danish: Human koagulationsfaktor X er stort set fastholdt i det vaskulære rum: den tilsyneladende gennemsnitlige fordelingsvolumen (Vss)
English: Step 6
Danish: Trin 6
English: 1 solvent vial of 5 mL water for injections
Danish: 1 hætteglas med opløsningsmiddel med 5 ml vand til injektionsvæske
English: Step 6: Immediately invert the vial of solution, which will be drawn into the syringe.
Danish: Trin 6: Vend straks hætteglasset med opløsningen på hovedet, hvorefter opløsningen vil blive trukket ind i sprøjten.
English: Other medicines and Coagadex
Danish: Brug af anden medicin sammen med Coagadex
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 5 mL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASETIKET 5 ml
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det (de) aktive stof(fer) eller over for et eller flere af hjælpestofferne er anført i pkt.
English: Prophylaxis of Bleeding Episodes
Danish: Profylakse af blødningsepisoder
English: Infusion site pain
Danish: Smerter omkring infusionsstedet
English: 1 solvent vial of 2.5 mL water for injections
Danish: 1 hætteglas med opløsningsmiddel med 2,5 ml vand til injektionsvæske
English: human coagulation factor X. - The other ingredients are: citric acid, disodium phosphate dihydrate, sodium chloride,
Danish: eller 500 IE human koagulationsfaktor X. - Øvrige indholdsstoffer: citronsyre, dinatriumfosfatdihydrat, natriumklorid, natriumhydroxid og sakkarose (se afsnit 2 for yderligere information om indholdsstoffer).
English: Presentations
Danish: Udformning
English: 1 vial 250 IU powder 1 vial 2.5 mL water for injections 1 Transfer Device (Mix2Vial)
Danish: 1 hætteglas 250 IE pulver 1 hætteglas 2,5 ml vand til injektionsvæske 1 overførselsenhed (Mix2Vial)
English: 1 vial 500 IU powder 1 vial 5 mL water for injections 1 Transfer Device (Mix2Vial)
Danish: 1 hætteglas 500 IE pulver 1 hætteglas 5 ml vand til injektionsvæske 1 overførselsenhed (Mix2Vial)
English: • Place the clear end of the transfer device on the powder vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Danish: • Placér den klare ende af overførselsenheden på pulverhætteglasset og skub lige ned, indtil spidsen trænger igennem gummiproppen og klikker på plads.
English: Solvent vial: water for injections.
Danish: Hætteglas med opløsningsmiddel: vand til injektionsvæske.
English: Judge each individual bleed on its own severity.
Danish: Vurdér sværhedsgraden af hver enkelt blødning.
English: Place the clear end of the transfer device on the powder vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Danish: Placér den klare ende af overførselsenheden på pulverhætteglasset og skub lige ned, indtil spidsen trænger gummiproppen og klikker på plads.
English: 1 vial 500 IU human coagulation factor X powder for solution for injection 1 vial 5 mL water for injections
Danish: 1 hætteglas 500 IE human koagulationsfaktor X-pulver injektionsvæske 1 hætteglas 5 ml vand til injektionsvæske 1 overførselsenhed (Mix2Vial)
English: 1 powder vial
Danish: 1 pulverhætteglas
English: • Place the blue end of the transfer device on the solvent vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Danish: • Placér den blå ende af overførselsenheden på hætteglasset med opløsningsmiddel og skub lige ned, indtil spidsen trænger igennem gummiproppen og klikker på plads.
English: Coagadex 250 IU powder and solvent for solution for injection.
Danish: Coagadex 250 IE, pulver og opløsningsmiddel til injektionsvæske.
English: Coagadex 500 IU powder and solvent for solution for injection.
Danish: Coagadex 500 IE, pulver og opløsningsmiddel til injektionsvæske.
English: Frequencies of uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Danish: (≥1/100 til <1/10).
English: • Turn the solvent vial upside down with the device still attached.
Danish: • Vend hætteglasset med opløsningsmiddel på hovedet, mens enheden stadig er fastgjort.
English: How to use Coagadex
Danish: Sådan skal du bruge Coagadex
English: What you need to know before you use Coagadex 3.
Danish: Det skal du vide, før du begynder at bruge Coagadex Sådan skal du bruge Coagadex Bivirkninger
English: When to inject Coagadex
Danish: Hvornår skal Coagadex injiceres?
English: coagadex 250 iu
Danish: Coagadex 250 IE
English: Coagadex 250 IU
Danish: Coagadex 250 ie
English: BATCH NUMBER>
Danish: FREMSTILLERENS BATCHNUMMER
English: Sodium Content
Danish: Natriumindhold
English: The study in young children (see section 5.1) measured incremental recovery at 30 min (IR30min) after the first dose and after the last dose in the study (approximately 6 months later) (see section 5.1) Combining IR30min values for FX:C at the baseline visit (n=9) and the Repeat PK assessment (n=9) gave an overall geometric mean IR of 1.74 (range 1.3-2.2) IU/dL per IU/kg administered (n=9).
Danish: En kombination af IR30min-værdierne for FX:C ved baseline-besøget (n=9) og den gentagne farmakokinetiske vurdering (n=9) gav en samlet geometrisk gennemsnitlig IR på 1,74 (interval 1,3-2,2) IE/dl pr. IE/kg administreret (n=9).
English: • tiredness
Danish: • rygsmerter
English: coagadex 500 iu
Danish: Coagadex 500 IE
English: Coagadex 500 IU
Danish: coagadex 500 ie
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 250 IU
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASETIKET 250 IE
English: How to store Coagadex
Danish: Opbevaring af Coagadex
English: Some patients may achieve desired FX trough levels on once weekly prophylactic therapy (see section 5.1).
Danish: Juster doseringsprogrammet til klinisk respons og minimumsniveauer af faktor X på mindst 5 IE/dL Nogle patienter kan opnå det ønskede minimumsniveau for faktor X med profylaktisk behandling en gang ugentligt (se pkt.
English: Coagadex 250 IU powder for solution for injection human coagulation factor X
Danish: Coagadex 250 IE pulver til injektionsvæske human koagulationsfaktor X
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 500 IU
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASETIKET 500 IE
English: Coagadex 500 IU powder for solution for injection human coagulation factor X
Danish: Coagadex 500 IE pulver til opløsning til injektionsvæske human koagulationsfaktor X
English: Coagadex 250 IU Coagadex 500 IU
Danish: Indlægsseddel: Information til patienten Coagadex 250 IE/ml Coagadex 500 IE
English: Coagadex 250 IU powder and solvent for solution for injection human coagulation factor X
Danish: Coagadex 250 IE pulver og opløsningsmiddel til injektionsvæske human koagulationsfaktor X
English: Coagadex 500 IU powder and solvent for solution for injection human coagulation factor X
Danish: Coagadex 500 IE pulver og opløsningsmiddel til injektionsvæske human koagulationsfaktor X
English: General disorders and administration site conditions Infusion site erythema Fatigue
Danish: Rødmen omkring infusionsstedet Træthed
English: 1 vial 250 IU human coagulation factor X powder for solution for injection 1 vial 2.5 mL water for injections
Danish: 1 hætteglas 250 IE human koagulationsfaktor X-pulver injektionsvæske
English: Date of first authorisation: 23 August 2012 Date of the latest renewal: 24 April 2017
Danish: Dato for første markedsføringstilladelse: 23. august 2012 Dato for seneste fornyelse: 24. april 2017
English: It is free of any particles.
Danish: De er fri for partikler.
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør lægemidlet anvendes med det samme.
English: One or more of these mechanisms may co-exist in a single bacterial isolate.
Danish: En eller flere af disse mekanismer kan findes i et enkelt bakterieisolat.
English: Dry powder: 3 years
Danish: Tørt pulver: 3 år
English: Resistant (R>)
Danish: Resistent (R>)
English: Renal changes were not reversible but were reduced in severity following a 4 week recovery period.
Danish: Nyreforandringer var ikke reversible, men var reduceret i sværhedsgrad efter en 4 ugers restitutionsperiode.
English: When stored as recommended, the product potency is not affected.
Danish: Når det opbevares som anbefalet, påvirkes produktets styrke ikke.
English: Do not use this medicine during pregnancy unless your doctor has told you to.
Danish: Brug ikke denne medicin under graviditet, medmindre din læge har fortalt dig, at du skal gøre det.
English: Alternatively they are stable for up to 24 hours under refrigerated storage.
Danish: Alternativt er de stabile i op til 24 timer ved opbevaring i køleskab.
English: Creatinine shows how well your kidneys are working.
Danish: Kreatinin viser, hvor godt dine nyrer fungerer.
English: Tell your doctor straight away if you get these symptoms as you may need urgent medical treatment:
Danish: Fortæl det straks til lægen, hvis du får disse symptomer, da du kan have behov for akut medicinsk behandling:
English: Treatment of overdose should follow standard medical practice;
Danish: Behandling ved overdosering bør følge medicinsk standardpraksis:
English: Calculated using the Cockcroft-Gault formula for adults.
Danish: Beregnet under anvendelse af Cockcroft-Gault-formlen for voksne.
English: Overall, the safety profile in these 227 patients was similar to that observed in the adult population.
Danish: Samlet set var sikkerhedsprofilen blandt disse 227 patienter den samme som blev set i den voksne population.
English: The hospital will dispose of any waste materials safely.
Danish: Hospitalet vil bortskaffe ethvert affaldsmateriale sikkert.
English: Caution is advised when treating such patients.
Danish: Forsigtighed tilrådes ved behandling af sådanne patienter.
English: Zinforo is used to treat children (from birth) and adults with:
Danish: Zinforo anvendes til behandling af børn (fra fødslen) og voksne med:
English: The usual recommended dose for children depends on the age and weight of the child and is given every 8 or 12 hours.
Danish: Den sædvanlige anbefalede dosis til børn afhænger af barnets alder og vægt og gives hver 8. eller 12. time.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der skal tages hensyn til officielle retningslinjer for korrekt brug af antibakterielle midler.
English: This may be because the level of platelets in your blood has dropped.
Danish: Dette kan skyldes, at antallet af blodplader i dit blod er faldet.
English: Infusion time (minutes)/Frequency
Danish: Infusionstid (minutter)/hyppighed
English: Infusion volumes for paediatric patients will vary according to the weight of the child.
Danish: Infusionsvolumen for pædiatriske patienter vil variere efter barnets vægt.
English: Do not use Zinforo if any of the above applies to you.
Danish: Brug ikke Zinforo, hvis noget af ovenstående gælder for dig.
English: Carcinogenicity studies have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier.
English: • If you have kidney problems (your doctor may have to prescribe a lower dose)
Danish: • hvis du har problemer med nyrerne (din læge vil muligvis ordinere en lavere dosis)
English: Adverse reactions are classified according to System Organ Class and frequency.
Danish: Bivirkningerne er klassificeret efter organsystemklasse og hyppighed.
English: No cases of CAP due to MRSA were enrolled into the studies.
Danish: Ingen tilfælde af CAP forårsaget af MRSA var inkluderet i studierne.
English: Frequency categories are derived according to the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), not known (cannot be estimated from the available data).
Danish: Hyppighedskategorierne er angivet i henhold til følgende konventioner: meget almindelig (≥ 1/10), almindelig (≥ 1/100, til < 1/10), ikke almindelig (≥ 1/1.000, til < 1/100), sjælden (≥ 1/10.000, til < 1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).