FrancophonIA/ELRC3.0 huggingface dataset:
English: Make sure the tip of the needle is always below the surface of the Water for Injections to help keep any air bubbles from entering the syringe.
Danish: Det er vigtigt, at spidsen af nålen hele tiden er under overfladen på væsken, så der ikke kommer luftbobler ind i sprøjten.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Særligt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART) er der rapporteret om tilfælde af osteonekrose.
English: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Danish: Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
English: bGrade 3= severe pain requiring analgesics (or narcotic analgesics for ≤ 72 hours) and/or limiting usual activities; Grade 4=
Danish: bGrad 3 = svær smerte med behov for analgetika (eller opioid i ≤ 72 timer) og/eller begrænsning i sædvanlige aktiviteter; Grad 4 = svær smerte med behov for hospitalisering eller forlængelse af hospitalisering, medførende død eller vedvarende eller betydelig funktionsnedsættelse; livstruende eller klinisk signifikant.
English: Powder and solvent for solution for injection
Danish: Pulver og solvens til injektionsvæske, opløsning
English: Push the syringe needle into the rubber top of the vial of Water for Injections and press the plunger.
Danish: Stik nålen gennem gummihætten på toppen af hætteglasset med vand til injektionsvæsker og tryk på stemplet, så luften trykkes ind i hætteglasset.
English: BL HIV-1 RNA < 5.0 log10
Danish: BL hiv-1-RNA < 5,0 1 kopier/ml log10
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Roche Pharma AG, Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen, Germany
Danish: Roche Pharma AG, Emil-Barrell-Str 1, D-79639 Grenzach-Wyhlen, Tyskland
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING IMMEDIATE OUTER CARTON FOR WATER FOR INJECTIONS VIALS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE YDRE KARTON TIL HÆTTEGLAS MED VAND TIL INJEKTIONSVÆSKER
English: Renal and Urinary Disorders Common
Danish: Nyrer og urinveje Almindelig
English: In addition there have been a small number of hypersensitivity reactions attributed to enfuvirtide and in some cases recurrence has occurred upon re-challenge (see section 4.4).
Danish: I nogle tilfælde er der forekommet recidiv efter provokation (se pkt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fuzeon 90 mg/ml powder for solution for injection Enfuvirtide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Fuzeon 90 mg/ml pulver til injektionsvæske, opløsning Enfuvirtid
English: 60 vials powder for solution for injection 60 vials solvent
Danish: 60 hætteglas pulver til injektionsvæske, opløsning 60 hætteglas solvens
English: Each ml of reconstituted solution contains 90 mg enfuvirtide.
Danish: Hver ml rekonstitueret opløsning indeholder 90 mg enfuvirtid.
English: The proportion of patients achieving viral load of <400 copies/ml at week 48 was 30.4% among patients on the Fuzeon + OB regimen compared to 12% among patients receiving OB regimen only.
Danish: Ved uge 48 havde 30,4 % patienter i Fuzeon + OB-gruppen en viral belastning < 400 kopier/ml sammenlignet med 12 % af patienterne i OB-gruppen.
English: 1 Active ARV in background1,2
Danish: 1 aktivt ARL i baggrundsbehandlin gen1,2
English: Do not use your free hand to press the device over the needle.
Danish: Brug ikke den anden hånd til at presse beskyttelseshætten på plads.
English: When the powder begins to dissolve you can put the vial aside to allow it to completely dissolve.
Danish: Når pulveret begynder at opløses, kan du sætte hætteglasset til side, indtil pulveret er helt opløst.
English: The remaining Water for Injections in the solvent vial after withdrawal of the 1.1 ml required for reconstitution has to be discarded
Danish: Efter at de 1,1 ml, som skal anvendes til rekonstituering, er udtaget fra solvenshætteglasset, skal den resterende volumen vand til injektionsvæsker i solvenshætteglasset kasseres
English: 247 (37.4%) 57 (17.1%) Odds Ratio HIV RNA <400 copies/ml** 201 (30.4%) 40 (12.0%) Odds Ratio HIV RNA <50 copies/ml**
Danish: Hiv-RNA < 400 kopier/ml** 201 (30,4 %) 40 (12,0
English: Mean (± SD) Cmax was 4.59 ± 1.5 µg/ml, AUC was 55.8 ± 12.1 µg*hr/ml The subcutaneous absorption of enfuvirtide is proportional to the administered dose over the 45 to 180 mg dose range.
Danish: Middel-Cmax (± SD) var 4,59 ± 1,5µg/ml, og AUC var 55,8 ± 12,1µg*time/ml.
English: Few patients included in the phase III trials were co-infected with hepatitis B/C.
Danish: I de kliniske fase III-forsøg var få patienter co-inficeret med hepatitis B/C. For disse patienter bevirkede tillæg af Fuzeon ikke en øgning af tilfælde af leverrelaterede bivirkninger.
English: In Vitro resistance to enfuvirtide: HIV-1 isolates with reduced susceptibility to enfuvirtide have been selected in vitro which harbour substitutions in amino acids (aa) 36-38 of the gp41 ectodomain.
Danish: Disse isolater har aminosyresubstitutionerne 36-38 i gp41 ektodomænet.
English: Push the syringe needle into the rubber top of the Fuzeon vial and press the plunger.
Danish: Stik nålen gennem gummihætten på toppen af hætteglasset med Fuzeon og tryk på stemplet, så luften trykkes ind i hætteglasset.
English: HIV-1 RNA < 400 copies/ml
Danish: Subgruppe hiv-1-RNA < 400 kopier/ml hiv-1-RNA < 50 kopier/ml
English: 1 ml of reconstituted solution contains 90 mg of enfuvirtide.
Danish: 1 ml rekonstitueret opløsning indeholder 90 mg enfuvirtid.
English: HIV-1 RNA < 50 copies/ml
Danish: Hiv-RNA < 50 kopier/ml**
English: Follow the instructions given to you by your doctor, pharmacist or nurse.
Danish: Følg lægen, apotekspersonalet eller sundhedspersonalets anvisning.
English: What Fuzeon is and what it is used for What you need to know before you use Fuzeon How to use Fuzeon
Danish: Det skal du vide, før du begynder at Fuzeon Sådan skal du bruge Fuzeon Bivirkninger
English: • nightmares
Danish: • mareridt
English: How to store Fuzeon
Danish: Sådan skal du tage Fuzeon
English: • Do not inject into moles, scar tissue, bruises or your belly button (navel).
Danish: • Giv aldrig indsprøjtningen i et modermærke, et ar, et blåt mærke eller i navlen.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ } Andre informationskilder
English: 60 vials with powder for solution for injection 60 vials with solvent
Danish: 60 hætteglas med pulver til injektionsvæske, opløsning 60 hætteglas med solvens
English: Fuzeon 90 mg/ml powder and solvent for solution for injection Enfuvirtide
Danish: Fuzeon 90 mg/ml pulver og solvens til injektionsvæske, opløsning Enfuvirtid
English: ● redness
Danish: • hævelse
English: Elimination: Clearance of enfuvirtide after intravenous administration 90 mg was 1.4 ± 0.28 l/h and the elimination half-life was 3.2 ± 0.42 h. Following a 90 mg subcutaneous dose of enfuvirtide the half-life of enfuvirtide is 3.8 ± 0.6 h. Mass balance studies to determine elimination pathway(s) of enfuvirtide have not been performed in humans.
Danish: Elimination: Enfuvirtid-clearance efter intravenøs administration af 90 mg var 1,4 ± 0,28 l/time, og eliminationshalveringstiden var 3,2 ± 0,42 timer.
English: Although these syringes have this safety feature, it is still important that you dispose of used syringes properly.
Danish: Hætten dækker nålen og beskytter mod, at andre ved et uheld stikker sig på den. Selvom sprøjten har denne sikkerhedsanordning, er det vigtigt, at sprøjterne efter brug bliver kasseret på den rigtige måde.
English: - Let the liquid get back to room temperature before using.
Danish: • Sørg for, at injektionsvæsken har stuetemperatur, inden du bruger den.
English: When the needle is in: - release the skin - use this free hand to hold on to the main part of the syringe - this will help steady it and stop it from moving.
Danish: • og bruger din frie hånd til at holde om selve sprøjten - som støtte, så den ikke flytter sig.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING IMMEDIATE OUTER CARTON FOR FUZEON VIALS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE YDRE KARTON TIL FUZEON HÆTTEGLAS
English: In four separate studies (N = 9 to 12) the mean steady state trough plasma concentration ranged from 2.6 to 3.4 µg/ml.
Danish: Den subkutane absorption efter en dosis på 90 mg er sammenlignelig og uafhængig af om den injiceres i abdomen, lår eller arm. I fire separate studier (N= 9 til 12) spændte middel steady state trough-plasmakoncentrationerne fra 2,6 til 3,4 µg/ml.
English: ● swelling
Danish: • halsbrand
English: Nasal congestion
Danish: Næsetilstopning
English: Other adverse reactions
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: • muscle pain
Danish: • muskelsmerter
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen, apoteketspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: • decreased sensation
Danish: • svaghedsfølelse
English: BL HIV-1 RNA ≥ 5.0
Danish: BL hiv-1-RNA ≥ 5,0 1 kopier/ml log10
English: • eczema
Danish: • eksem
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig
English: Hold the main part of the water-filled syringe and push the needle through the rubber top of the vial at a slight angle.
Danish: Hold på sprøjten med vandet og stik nålen skråt igennem gummiproppen på hætteglasset med Fuzeon.
English: Excipient with known effect: sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Natrium.
English: What you need to know before you use Fuzeon
Danish: Det skal du vide, før du begynder at tage Fuzeon Tag ikke Fuzeon, hvis
English: Roche Nederland B.V. Tel: +31 (0) 348 438050
Danish: Tel: +31 (0) 348 438050
English: - Then pull out the liquid again.
Danish: • Herefter kan du trække opløsningen op igen.
English: Clean the tops of the vials.
Danish: Lad toppen af hætteglassene lufttørre.
English: Dispose of the vial and the Water for Injections into your special waste container with a lid - this vial is for single use only.
Danish: 10. Smid hætteglasset med vandet til injektionsvæsker i den særlige affaldsbeholder med låghætteglasset må kun bruges én gang.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Danish: Patienter, der oplever ømme og smertende led, ledstivhed eller bevægelsesbesvær bør rådes til at søge læge.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse:
English: Putting in the needle and injecting
Danish: Sådan stikker du nålen ind og giver indsprøjtningen:
English: • you are allergic to enfuvirtide or any of the other ingredients of this medicine (listed in section If you are not sure, talk to your doctor, pharmacist or nurse before using Fuzeon.
Danish: • du er allergisk over for enfuvirtid eller et af de øvrige indholdsstoffer i denne medicin (angivet i afsnit 6).
English: Where to Inject
Danish: Vælg et sted at give indsprøjtningen
English: Hold the main part of the syringe with one hand - then gently press the coloured needle protector down on a flat surface until it covers the needle.
Danish: • pres herefter den farvede beskyttelseshætte ned mod en flad overflade, indtil den dækker nålen.
English: CD4 >100 cells/mm3, baseline HIV-1 RNA <5.0 log10 copies/ml, ≤ 10 prior ARVs, and/or other active
Danish: Uanset behandling havde patienter med CD4 > 100 celler/mm3 ved baseline, hiv-1-RNA < 5,0 log10 kopier/ml ved baseline,
English: lyophilisate stopper, rubber (latex free)
Danish: latexfri gummilukke Forsegling: aluminiumsforsegling med aftagelig beskyttelseshætte
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret at forekomme i forbindelse med immunreaktivering.
English: Mothers should be instructed not to breast-feed if they are receiving enfuvirtide because of the potential for HIV transmission and any possible undesirable effects in breast-fed infants.
Danish: På grund af risikoen for overførsel af hiv og for eventuelle bivirkninger hos de ammede børn, skal mødre frarådes at amme, hvis de får enfuviritid.
English: Posology
Danish: Endepunkter
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl så spørg lægen, apotekspersonalet eller sundhedspersonalet.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: Der henvises til produktresuméerne for de relevante produkter, hvis patienten samtidig er i antiviral behandling for hepatitis B eller C.
English: ● bruises
Danish: • svimmelhed
English: - If you see any bits in the liquid, do not use it. - Dispose of the vial into the special waste container with a lid or return it to the pharmacy.
Danish: Smid hætteglasset i den særlige affaldsbeholder med låg eller returner det til apoteket, og begynd forfra
English: NAME OF THE MEDICINAL PRODUCT Fuzeon 90 mg/ml powder and solvent for solution for injection
Danish: LÆGEMIDLETS NAVN Fuzeon 90 mg/ml, pulver og solvens til injektionsvæske, opløsning.
English: • inflamed sinuses
Danish: • tilstoppet næse
English: If there is any blood where you have given the injection, cover the skin with a sticking plaster.
Danish: Sæt et plaster på, hvis der siver blod fra indsprøjtningsstedet.
English: If you use more Fuzeon than you should
Danish: Hvis du har taget for meget Fuzeon
English: • diabetes,
Danish: • sukkersyge
English: Musculoskeletal, connective tissue and bone disorders
Danish: Knogler, led, muskler og bindevæv Almindelig
English: Induration d d
Danish: Induration
English: Method of Administration
Danish: Administration
English: NAME OF THE MEDICINAL PRODUCT Fuzeon 90 mg/ml powder for solution for injection Enfuvirtide
Danish: Fuzeon 90 mg/ml pulver til injektionsvæske, opløsning Enfuvirtid
English: If you get anyside effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: DATE OF REVISION OF THE TEXT
Danish: Opbevaring efter rekonstituering
English: Pain / discomfort b b
Danish: Smerte/ubehag
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: • Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre,
English: - The powder may take up to 45 minutes to dissolve into solution.
Danish: Når pulveret er begyndt at opløses, kan patienten sætte hætteglasset til side, indtil pulveret er helt opløst, hvilket kan tage op til 45 minutter.
English: NAME OF THE MEDICINAL PRODUCT Solvent for solution
Danish: LÆGEMIDLETS NAVN
English: - Dispose of packaging and vial caps into your special waste container with a lid. - Place syringes and vials onto a clean surface.
Danish: • Smid indpakningen og lågene til hætteglassene i den særlige affaldsbeholder
English: This can be serious.
Danish: Kan være alvorlig.
English: Further dilution is required.
Danish: Yderligere fortynding er påkrævet.
English: Toxicity was predictable and reversible.
Danish: Toksiciteten var forudsigelig og reversibel.
English: Ask your doctor for advice.
Danish: Spørg lægen om råd.
English: Reactions have been mild and have not generally required specific therapy.
Danish: Reaktionerne har været milde og har generelt ikke krævet specifik behandling.
English: • if your blood cell counts are too low.
Danish: • hvis dine blodcelletal er for lave.
English: This can even be life threatening.
Danish: Dette kan blive livstruende.
English: • if you are pregnant or plan to become pregnant.
Danish: • hvis du er gravid eller planlægger at blive gravid.
English: Age/weight
Danish: Alder/vægt
English: In some cases you may need a blood transfusion.
Danish: I nogle tilfælde kan det være nødvendigt, at du får en blodtransfusion.
English: Table 2 Study results Study GOG-0179
Danish: Tabel 2 Resultater studie GOG-0179
English: Study 396
Danish: Studie 396
English: This increase is considered unlikely to be of clinical relevance.
Danish: Det er vurderet usandsynligt, at denne stigning har klinisk relevans.
English: This medicine is for single use only.
Danish: Dette lægemiddel er kun til engangsbrug.
English: Each blister contains 10 capsules.
Danish: Hver blister indeholder 10 kapsler.
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Danish: Dette kan medføre alvorlige blødninger fra relativt små skader så som en lille rift.
English: The clinical significance of this finding is unclear.
Danish: Den kliniske betydning af dette er uklar.
English: Male patients who wish to father a child should ask their doctor for family planning advice or treatment.
Danish: Mandlige patienter, som ønsker at blive far, skal spørge lægen til råds om familieplanlægning eller behandling.
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Danish: Den gennemsnitlige halveringstid steg fra 1,9 time til 4,9 time.
English: This pattern of treatment will normally be repeated every 3 weeks.
Danish: Dette behandlingsmønster vil normalt blive gentaget hver 3. uge.
English: • the results of blood tests carried out before treatment
Danish: • resultaterne af blodprøverne, der er udført inden behandlingens start
English: Date of first authorisation: 12 November 1996 Date of latest renewal: 20 November 2006
Danish: Dato for første markedsføringstilladelse: 12. november 1996 Dato for seneste fornyelse: 20. november 2006
English: Study 065
Danish: Studie 065
English: If your partner becomes pregnant during your treatment, tell your doctor immediately.
Danish: Hvis din partner bliver gravid under din behandling, skal du straks fortælle det til lægen.
English: The frequency of some side effects is not known (events from spontaneous reports and the frequency cannot be estimated from the available data):
Danish: Hyppigheden af nogle bivirkninger er ikke kendt (hændelser fra spontane rapporteringer, og hyppigheden kan ikke bestemmes ud fra de tilgængelige data):
English: It may harm a baby conceived before, during or soon after treatment.
Danish: Et ufødt barn kan blive skadet før, under og lige efter behandlingen.
English: Your doctor will determine the correct dose of cisplatin.
Danish: Din læge vil fastlægge den korrekte dosering af cisplatin.
English: Patients with Grade 2 diarrhoea may need to follow the same dose modification guidelines.
Danish: Patienter med grad 2 diarré kan have behov for at følge den samme dosismodificeringsvejledning.
English: Your doctor will tell you whether this is the case, based on the results of your last blood test.
Danish: Din læge vil give dig besked, hvis dette er tilfældet på baggrund af resultaterne fra din seneste blodprøve.
English: Before you are given this medicine your doctor needs to know:
Danish: Inden du får denne medicin, skal lægen vide:
English: Volume of distribution was slightly decreased and thus half-life only increased by 14%.
Danish: Distributionsvolumen faldt en anelse, hvorved halveringstiden kun steg 14 %.
English: • Signs of infections: Hycamtin may reduce the number of white blood cells and lower your resistance to infection.
Danish: • Tegn på infektion: Hycamtin kan nedsætte antallet af hvide blodceller og nedsætte din modstandsdygtighed over for infektioner.
English: Talk to your doctor for advice on how to minimise the risk of bleeding.
Danish: Tal med lægen om, hvordan risikoen for blødninger kan minimeres.
English: You should use an effective method of contraception.
Danish: Du skal bruge en effektiv præventionsmetode.
English: The treatment may vary, depending on the results of your regular blood tests.
Danish: Behandlingen kan variere afhængigt af resultaterne af dine blodprøver.
English: Frequencies are defined as: 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), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som: 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), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • High body temperature (fever).
Danish: • Høj kropstemperatur (feber).
English: In this analysis, creatinine clearance was calculated using the Cockcroft-Gault method.
Danish: I denne analyse blev kreatinin-clearance beregnet ved brug af Cockcroft-Gault-metoden.
English: Overall, 87 complete and partial responses were observed, with 13 of these occurring during cycles 5 and 6 and 3 occurring thereafter.
Danish: Samlet set blev 87 fuldstændige og partielle responser observeret, heraf 13, som optrådte mellem 5. og 6. serie, og 3, som optrådte derefter.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis lægemidlet ikke anvendes straks, er opbevaringstid og -forhold inden anvendelse brugerens ansvar.
English: Hycamtin is not recommended for pregnant women.
Danish: Hycamtin bør ikke gives til gravide kvinder.
English: Just take the next dose at the scheduled time.
Danish: Du skal blot tage den næste dosis på det sædvanlige tidspunkt.
English: The product should be used immediately after reconstitution as it contains no antibacterial preservative.
Danish: Produktet skal bruges umiddelbart efter rekonstituering, da det ikke indeholder et antibakterielt konserveringsmiddel.
English: Pancytopenia has been reported.
Danish: Pancytopeni er rapporteret.
English: 90429 Nuremberg Germany
Danish: 90429 Nürnberg Tyskland
English: After opening, the product should be used immediately.
Danish: Efter åbning skal lægemidlet anvendes straks.
English: The product should be used immediately after it is prepared for infusion.
Danish: Produktet skal anvendes umiddelbart efter, at det er tilberedt til infusion.
English: No in vivo human pharmacokinetic interaction studies have been performed.
Danish: Der er ikke udført in vivo humane farmakokinetiske interaktionsstudier.
English: It may harm them, even if their symptoms seem to be the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
English: Contact a doctor or pharmacist immediately for advice if you have taken too many capsules or if a child has accidentally taken the medicine.
Danish: Kontakt straks lægen eller apoteket, hvis du har taget for mange kapsler eller hvis et barn ved et uheld har taget medicinen.
English: No studies of the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: Reconstitute before use.
Danish: Skal rekonstitueres før brug.
English: Store in a refrigerator (2ºC - 8ºC).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: Tell your doctor if any of these applies to you.
Danish: Tal med lægen, hvis noget af ovenstående gælder for dig.
English: The median time to response in clinical studies was 7.6-11.6 weeks.
Danish: I kliniske studier var mediantiden til respons 7,6-11,6 uger.