FrancophonIA/ELRC3.0 huggingface dataset:
English: The pre-set dose provided by the I-Neb AAD nebuliser is controlled by the medication chamber in combination with a control disc.
Danish: Den forudindstillede dosis, som I-Neb AAD-nebulisatoren giver, kontrolleres af medicineringskammeret i kombination med en kontroldisk.
English: Ventavis 10 microgram/ml nebuliser solution 4 years.
Danish: Ventavis 10 mikrogram/ml inhalationsvæske til nebulisator, opløsning 4 år
English: 1 ml solution contains 20 microgram iloprost (as iloprost trometamol).
Danish: 1 ml opløsning indeholder 20 mikrogram iloprost (som iloprost trometamol).
English: 1 ml ampoule yellow - red ring 5 mcg golden golden
Danish: 1 ml-ampul gul-rød ring 5 mikrogram gylden gylden
English: • 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (yellow - red).
Danish: • 1 ml ampuller, farveløs, glastype I, indeholdende 1 ml opløsning til nebulisator, kodet med to farvede ringe (gul - rød).
English: Just before you start to inhale, break the glass ampoule containing 2 ml solution, which has two coloured rings (white-pink), and pour the complete contents into the nebuliser medication chamber.
Danish: Lige inden du begynder at inhalere, knækker du spidsen af glasampullen med 2 ml opløsning, som har to farvede ringe (hvid - lyserød) og overfører hele indholdet til nebulisatorkammeret.
English: 30 ampoules with 1 ml.
Danish: 30 ampuller med 1 ml.
English: 1 ml ampoule white - yellow ring
Danish: 1 ml ampul hvid - gul ring
English: Ventavis 20 microgram/ml is provided in colourless ampoules, containing 1 ml nebuliser solution.
Danish: Ventavis 20 mikrogram/ml er i farveløse ampuller, der indeholder 1 ml inhalationsvæske til nebulisator, opløsning.
English: In a study with intravenous infusion of iloprost, patients with end-stage renal failure undergoing intermittent dialysis treatment are shown to have a significantly lower clearance (mean CL = 5 ± 2 ml/minute/kg) than that observed in patients with renal failure not undergoing intermittent dialysis treatment (mean CL = 18 ± 2 ml/minute/kg).
Danish: = 5 ± 2 ml/minut/kg) end observeret hos patienter med nyresvigt, som ikke gennemgik regelmæssig dialysebehandling (middel-CL = 18 ± 2 ml/minut/kg).
English: To obtain the optimal droplet size for the administration of Ventavis 10 microgram/ml nebuliser solution the green baffle plate should be used.
Danish: Den grønne prelplade anvendes til at opnå den optimale dråbestørrelse til administrering af Ventavis 10 mikrogram/ml inhalationsvæske til nebulisator.
English: Pharmacokinetics under the specific study conditions of extended inhalation time, were investigated in a randomised, crossover study with 19 healthy adult men following inhalation of single doses of Ventavis 10 microgram/ml and Ventavis 20 microgram/ml (dose of 5 microgram iloprost at the mouthpiece) using the I-Neb.
Danish: Farmakokinetikken under de særlige studiebetingelser med forlænget inhalationstid blev undersøgt i et randomiseret overkrydsningsstudie med 19 raske, voksne mænd efter inhalation af enkeltdoser af Ventavis 10 mikrogram/ml og Ventavis 20 mikrogram/ml (dosis på 5 mikrogram iloprost ved mundstykket) med I-Neb. Der blev fundet sammenlignelige systemiske eksponeringer (AUC (0-tlast)) og ca. 30 % højere maksimale serumkoncentrationer (Cmax) efter inhalation af Ventavis 20 mikrogram/ml sammenlignet med Ventavis 10 mikrogram/ml, hvilket stemte overens med den observerede kortere inhalationstid med Ventavis 20 mikrogram/ml.
English: • P1 Programme 1: 5 microgram active substance on the mouth piece 25 inhalation cycles.
Danish: • P1 Program 1: 5 mikrogram aktivt stof ved mundstykket 25 inhalationscyklusser.
English: 30 AMPOULES WITH 1 ML
Danish: 30 AMPULLER MED 1 ML
English: In case of poor tolerability of the 5 microgram dose, the dose should be reduced to 2.5 microgram iloprost.
Danish: Hvis dosis på 5 mikrogram tolereres dårligt, reduceres dosis til 2,5 mikrogram iloprost.
English: The pre-set dose provided by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc.
Danish: Den forudindstillede dosis, som I-Neb AAD-systemet giver, kontrolleres af medicineringskammeret i kombination med en kontroldisk.
English: 42 ampoules with 1 ml.
Danish: 42 ampuller med 1 ml.
English: Vasodilatation Flushing
Danish: Flushing
English: 168 (4 x 42) AMPOULES WITH 1 ML CO-PACKED WITH BREELIB CONSUMABLES SET
Danish: 168 (4 x 42) AMPULLER MED 1 ML SAMMEN MED BREELIB TILBEHØRSSÆT
English: 90 ampoules with 2 ml.
Danish: 90 ampuller med 2 ml.
English: Hydrochloric acid (for pH adjustment) Water for injections
Danish: Ethanol 96% Natriumchlorid Saltsyre (til pH-justering) Vand til injektionsvæsker
English: Ventavis 20 microgram/ml nebuliser solution Clear, colourless to slightly yellowish solution.
Danish: Ventavis 20 mikrogram/ml inhalationsvæske til nebulisator, opløsning Klar, farveløs til let gullig opløsning
English: • 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (white - yellow).
Danish: • 1 ml ampuller, farveløs, glastype I, indeholdende 1 ml opløsning til nebulisator, kodet med to farvede ringe (hvid - gul).
English: EU/1/03/255/013 [168 (4 x 42) x 1 ml] co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Danish: EU/1/03/255/013 [168 (4 x 42) x 1 ml] sammen med Breelib-tilbehørssæt (indeholdende 1 mundstykke og 1 medicineringskammer).
English: 300 ampoules with 2 ml.
Danish: 300 ampuller med 2 ml.
English: EU/1/03/255/014 [168 (4 x 42) x 1 ml] co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Danish: EU/1/03/255/014 [168 (4 x 42) x 1 ml] sammen med Breelib-tilbehørssæt (indeholdende 1 mundstykket og 1 medicineringskammer).
English: Ventavis 20 microgram/ml
Danish: Ventavis 20 mikrogram/ml
English: P2 Programme 2: 2.5 microgram active substance on the mouth piece 10 inhalation cycles.
Danish: P2 Program 2: 2,5 mikrogram aktivt stof ved mundstykket, 10 inhalationscyklusser.
English: 30 ampoules with 2 ml.
Danish: 30 ampuller med 2 ml.
English: Multipack: 168 (4 x 42) ampoules with 1 ml.
Danish: Multipakning: 168 (4 x 42) ampuller med 1 ml
English: Just before you start to inhale, break the glass ampoule containing 1 ml solution, which has two coloured rings (white - yellow), and pour the complete contents into the nebuliser medication chamber.
Danish: Lige inden du begynder at inhalere, knækker du spidsen af glasampullen med 1 ml opløsning, som har to farvede ringe (hvid - gul) og overfører hele indholdet til nebulisatorkammeret.
English: P1 Programme 1: 5 microgram active substance on the mouth piece 25 inhalation cycles.
Danish: P1 Program 1: 5 mikrogram aktivt stof ved mundstykket, 25 inhalationscyklusser.
English: Using more Ventavis than you should may lead to dizziness, headache, flushing (reddening of the face), nausea (feeling sick), jaw pain or back pain.
Danish: Hvis du har taget for meget Ventavis, kan det medføre svimmelhed, hovedpine, ansigtsrødmen, kvalme, kæbe- eller rygsmerter.
English: Package leaflet: Information for the user Ventavis 10 microgram/ml nebuliser solution
Danish: Indlægsseddel: Information til brugeren Ventavis 10 mikrogram/ml inhalationsvæske til nebulisator, opløsning iloprost
English: 100 ampoules with 2 ml.
Danish: 100 ampuller med 2 ml.
English: 42 AMPOULES WITH 1 ML
Danish: 42 ampuller med 1 ml
English: Ampoule coloured ring
Danish: Ampul farvet ring
English: For the 5 microgram dose of Ventavis 20 microgram/ml the medication chamber with the gold coloured latch is used together with the gold control disc.
Danish: Til en dosis på 5 mikrogram af Ventavis 20 mikrogram/ml anvendes medicineringskammeret med den gyldne pal sammen med den gyldne kontroldisk.
English: • if you have had a stroke within the last 3 months, or any other occurrence that reduced the blood supply to the brain (e.g. transient ischaemic attack),
Danish: • hvis du har haft et slagtilfælde inden for de sidste 3 måneder eller en anden hændelse,
English: Ventavis 20 microgram/ml; 1 ml
Danish: Ventavis 20 mikrogram/ml; 1 ml
English: How to use Ventavis
Danish: Sådan skal du bruge Ventavis
English: Ventavis 10 microgram/ml
Danish: Ventavis 10 mikrogram/ ml
English: For each inhalation session, the content of one ampoule containing 2 ml of Ventavis 10 microgram/ml nebuliser solution and marked with two coloured rings (white - pink) is transferred into the nebuliser medication chamber immediately before use.
Danish: Til hver inhalationsbehandling skal indholdet af en ampul med 2 ml Ventavis 10 mikrogram/ml -nebulisatoropløsning og som er markeret med to farvede ringe (hvid - lyserød) overføres til nebulisatorkammeret umiddelbart inden brug.
English: In general, when starting Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece.
Danish: Normalt skal den første inhalerede dosis ved starten af Ventavis-behandlingen være 2,5 mikrogram iloprost indgivet via mundstykket.
English: Patients stabilised on one nebuliser should not switch to another nebuliser without supervision by the treating physician as different nebulisers have been shown to produce aerosols with slightly different physical characteristics and delivery of the solution that may be faster (see section 5.2).
Danish: Da forskellige nebulisatorer har vist sig at producere aerosoler med svagt afvigende fysiske karakteristika og en tilførsel af opløsningen, der kan være hurtigere (se pkt.
English: Ventavis 10 microgram/ml nebuliser solution 1 ml solution contains 10 microgram iloprost (as iloprost trometamol).
Danish: Ventavis 10 mikrogram/ml inhalationsvæske til nebulisator, opløsning 1 ml vandig opløsning indeholder 10 mikrogram iloprost (som iloprosttrometamol).
English: • I-Neb nebuliser
Danish: • I-Neb-nebulisator
English: PACK WITH 42 AMPOULES IN A CARTON WITH 168 (4 x 42) AMPOULES WITH 1 ML PACK WITH 42 AMPOULES IN A CARTON WITH 168 (4 x 42) AMPOULES WITH 1 ML CO-PACKED WITH BREELIB CONSUMABLES SET
Danish: EMBALLAGE MED 42 AMPULLER I EN PAKKE MED 168 (4 X 42) AMPULLER MED 1 ML SAMMEN MED BREELIB-TILBEHØRSSÆT
English: Ventavis 10 microgram/ml; 1 ml
Danish: Ventavis 10 mikrogram/ml; 1 ml
English: Ventavis 20 microgram/ml nebuliser solution 1 ml solution contains 20 microgram iloprost (as iloprost trometamol).
Danish: Ventavis 20 mikrogram/ml inhalationsvæske til nebulisator, opløsning 1 ml vandig opløsning indeholder 20 mikrogram iloprost (som iloprosttrometamol).
English: Ventavis 10 microgram/ml nebuliser solution (1 ml ampoule)
Danish: Ventavis 10 mikrogram/ml inhalationsvæske til nebulisator, opløsning (1 ml-ampul)
English: For each inhalation session with the I-Neb AAD, the content of one 1-ml ampoule of Ventavis 20 microgram/ml, showing two coloured rings (-yellow-red), will be transferred into the appropriate nebuliser medication chamber with golden coloured latch together with the golden colour disc immediately before use.
Danish: Til hver inhalationsbehandling med I-Neb AAD overføres indholdet af en ampul med 1 ml Ventavis 20 mikrogram/ml, som har to farvede ringe (gul-rød), til det relevante nebulisatormedicineringskammer med den gyldne pal sammen med den gyldne disk umiddelbart før brug.
English: - Multipack containing 168 (4x42) ampoules with Breelib consumables set (containing 1
Danish: - Multipakning med 168 (4x42) ampuller med Breelib-tilbehør (indeholdende 1 mundstykke og
English: If you tolerate this dose well, your dose should be increased to 5 microgram and you should continue on this dose.
Danish: Hvis du kan tåle denne dosis, skal dosis øges til 5 mikrogram,, som du skal fortsætte med.
English: Each ampoule with 1 ml contains 10 microgram iloprost.
Danish: Hver ampul med 1 ml indeholder 10 mikrogram iloprost.
English: For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis, with two coloured rings (white - yellow) is transferred into the medication chamber immediately before use.
Danish: Til hver inhalationsbehandling med I-Neb AAD overføres indholdet af en ampul med 1 ml Ventavis, som har to farvede ringe (hvid - gul), til medicineringskammer umiddelbart før brug.
English: Each ampoule with 2 ml contains 20 microgram iloprost.
Danish: Hver ampul med 2 ml indeholder 20 mikrogram iloprost.
English: To obtain the optimal droplet size for the administration of Ventavis the green baffle plate should be used.
Danish: Den grønne prelplade anvendes til at opnå den optimale dråbestørrelse til administrering af Ventavis.
English: • For the 5 microgram dose the medication chamber with the purple coloured latch is used together with the purple control disc.
Danish: • Til dosis på 5 mikrogram anvendes medicineringskammeret med den lilla pal sammen med den lilla kontroldisk.
English: Ventavis 20 microgram/ml nebuliser solution
Danish: Ventavis 20 mikrogram/ml inhalationsvæske til nebulisator
English: Ventavis 10 microgram/ml; 2 ml
Danish: Ventavis 10 mikrogram/ml, 2 ml
English: 6.5 Nature and contents of container Ventavis 10 microgram/ml nebuliser solution
Danish: 6.5 Emballagetype og pakningsstørrelser Ventavis 10 mikrogram/ml inhalationsvæske til nebulisator, opløsning
English: Ventavis 10 microgram/ml nebuliser solution Ventavis 20 microgram/ml nebuliser solution
Danish: Ventavis 10 mikrogram/ml inhalationsvæske til nebulisator, opløsning Ventavis 20 mikrogram/ml inhalationsvæske til nebulisator, opløsning
English: ACE inhibitors.
Danish: o eptifibatid,
English: Part of a multipack containing 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Danish: Del af multipakning indeholdende 168 (4 x 42) ampuller med 1 ml sammen med Breelib tilbehørssæt (indeholdende 1 mundstykke og 1 medicineringskammer).
English: If you tolerate this dose well, your dose should be increased to 5 microgram iloprost and you should continue on this dose.
Danish: Hvis du kan tåle denne dosis, skal dosis øges til 5 mikrogram iloprost, som du skal fortsætte med.
English: Each ampoule with 1 ml contains 20 microgram iloprost.
Danish: Hver ampul med 1 ml indeholder 20 mikrogram iloprost.
English: Multipack: 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Danish: Multipakning: 168 (4 x 42) ampuller med 1 ml sammen med Breelib tilbehørssæt (indeholdende 1 mundstykke og 1 medicineringskammer).
English: For each inhalation session with the Venta-Neb, the content of one 2 ml ampoule of Ventavis 10 microgram/ml with two coloured rings (white - pink) is transferred into the nebuliser medication chamber immediately before use.
Danish: Til hver inhalationsbehandling med Venta-Neb overføres indholdet af en ampul med 2 ml Ventavis 10 mikrogram/ml, som har to farvede ringe (hvid - lyserød) til nebulisatorkammeret umiddelbart før brug.
English: Pack containing 30 or 42 ampoules for use with the Breelib and I-Neb nebuliser.
Danish: • 1 ml ampuller til Breelib- eller I-Neb-nebulisatorer: - Pakke med 30 eller 42 ampuller til brug med Breelib- eller I-Neb-nebulisatorer.
English: Ampoule coloured rings
Danish: Ampul / farvede ringe
English: The ready-to-use Ventavis nebuliser solution is administered with a suitable inhalation device (nebuliser) (see below and section 6.6).
Danish: Ventavis 10 mikrogram/ml nebulisatoropløsning, der er klar til brug, administreres med en egnet inhalationsanordning (nebulisator) (se pkt.
English: Ventavis 10 microgram/ml, nebuliser solution Iloprost
Danish: Ventavis 10 mikrogram/ml, inhalationsvæske til nebulisator, opløsning Iloprost
English: Patients stabilised on one nebuliser should not switch to another nebuliser without close supervision by the treating doctor as different nebulisers have been shown to produce aerosols with slightly different physical characteristics and may have faster delivery of the solution (see section 5.2 of the Summary of Product Characteristics).
Danish: 5.2 i produktresuméet), bør patienter, der er stabiliseret på en nebulisator, ikke skifte til en anden nebulisator uden nøje tilsyn fra den behandlende læge.
English: Hepatic impairment
Danish: Hvæsende vejrtrækning
English: What Ventavis is and what it is used for What you need to know before you use Ventavis How to use Ventavis
Danish: Det skal du vide, før du begynder at bruge Ventavis Sådan skal du bruge Ventavis Bivirkninger
English: For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 20 microgram/ml with two coloured rings (yellow - red), is transferred into the medication chamber immediately before use.
Danish: Til hver inhalationsbehandling med I-Neb AAD overføres indholdet af en ampul med 1 ml Ventavis 20 mikrogram/ml, som har to farvede ringe (gul - rød), til det relevante nebulisatormedicineringskammer umiddelbart før brug.
English: Ventavis 10 microgram/ml, Nebuliser solution Iloprost
Danish: Ventavis 10 mikrogram/ml inhalationsvæske til nebulisator, opløsning Iloprost
English: Drug product
Danish: Lægemiddel
English: Posology
Danish: Diaré
English: For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 10 microgram/ml, with two coloured rings (white - yellow), is transferred into the medication chamber immediately before use.
Danish: Til hver inhalationsbehandling med I-Neb AAD overføres indholdet af en ampul med 1 ml Ventavis 10 mikrogram/ml, som har to farvede ringe (hvid - gul), til det relevante nebulisatormedicineringskammer umiddelbart før brug.
English: 5 mcg
Danish: 5 mikrogram Lilla
English: Each ampoule with 1 ml solution contains 10 microgram iloprost.
Danish: Hver ampul med 1 ml opløsning indeholder 10 mikrogram iloprost.
English: Syncope is a common symptom of the disease itself, but can also occur under therapy.
Danish: Synkope er et hyppigt symptom på selve sygdommen, men kan også optræde under behandlingen med Ventavis.
English: Each ampoule with 2 ml solution contains 20 microgram iloprost.
Danish: Hver ampul med 2 ml opløsning indeholder 20 mikrogram iloprost.
English: Bayer S.p.A. Tel: +39 02 397 81
Danish: Tel: +39 02 397 81
English: Each ampoule with 1 ml solution contains 20 microgram iloprost.
Danish: Hver ampul med 1 ml opløsning indeholder 20 mikrogram iloprost.
English: For the 5 microgram dose of Ventavis 10 microgram/ml the medication chamber with the purple coloured latch is used together with the purple control disc.
Danish: Til en dosis på 5 mikrogram Ventavis 10 mikrogram/ml anvendes medicineringskammeret med den lilla pal sammen med den lilla kontroldisk.
English: • 168 (4x42) ampoules co-packed with Breelib consumables set (containing 1 mouthpiece and 1
Danish: • 168 (4x42) ampuller i en pakke sammen med Breelib-tilbehør (indeholdende 1 mundstykke og 1 medicineringskammer).
English: 30 ampoules with 1 ml 42 ampoules with 1 ml Multipack: 168 (4 x 42) ampoules with 1 ml
Danish: EMBALLAGE MED 42 AMPULLER I EN PAKKE MED 168 (4 X 42) AMPULLER MED 1 ML
English: Ventavis 20 microgram/ml nebuliser solution Iloprost
Danish: Ventavis 20 mikrogram/ml inhalationsvæske til nebulisator, opløsning Iloprost
English: Just before you start to inhale, take the yellow-red colour coded ampoule of Ventavis 20 microgram/ml, break the glass ampoule and pour the complete contents of 1 ml into the nebuliser medication golden chamber.
Danish: Lige inden du begynder at inhalere, tager du ampullen med Ventavis 20 mikrogram/ml, som er farvekodet gul-rød.
English: I-Neb AAD nebuliser:
Danish: I-Neb AAD-nebulisator:
English: Chest discomfort / chest pain Cough
Danish: Ubehag i brystet/brystsmerter Hoste
English: Ventavis 10 mcg/ml
Danish: Ventavis 10 mikrogram/ml
English: • rash
Danish: • Hoste
English: ILD may be fatal.
Danish: ILD kan være dødelig.
English: Use of alternative contraceptive methods is recommended.
Danish: Anvendelse af alternative antikonceptionsmetoder anbefales.
English: The study results are shown in Table 1.
Danish: Undersøgelsens resultater vises i tabel 1.
English: The mean age of the study population was 37.9 years.
Danish: Gennemsnitsalderen for studiepopulationen var 37,9 år.
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 28 May 2018
Danish: Dato for første markedsføringstilladelse: 26. august 2013 Dato for seneste fornyelse: 28. maj 2018
English: Potential to prolong the QT interval
Danish: Potentiale til at forlænge QT-intervallet
English: Accelerated elimination procedure
Danish: Accelereret eliminationsprocedure
English: If they become pregnant:
Danish: Hvis patienten bliver gravid:
English: Efficacy in patients with high disease activity:
Danish: Effekt hos patienter med høj sygdomsaktivitet:
English: • balance problems.
Danish: • balanceproblemer.
English: Nevertheless, their impact remains limited (31%).
Danish: Ikke desto mindre er disses indvirkning begrænset (≤31 %).
English: These symptoms vary from patient to patient but usually involve:
Danish: Disse symptomer varierer fra patient til patient, men omfatter normalt:
English: - you are lactose intolerant.
Danish: - Hvis du er lactoseintolerant.
English: Characteristics in specific groups of patients
Danish: Egenskaber i specifikke patientgrupper
English: The choice between the 3 elimination procedures should depend on the patient's tolerability.
Danish: Valget mellem de 3 eliminationsprocedurer skal ske på baggrund af patientens tolerabilitet.
English: Do not take AUBAGIO if you are, or think you may be pregnant.
Danish: Tag ikke AUBAGIO, hvis du er, eller tror du kan være, gravid.
English: Serious opportunistic infections occurred in 0.2% of each group.
Danish: Alvorlige, opportunistiske infektioner forekom hos 0,2 % i hver gruppe.
English: What multiple sclerosis is
Danish: Hvad er multipel sclerose
English: Table 1 - Main Results ( for the approved dose, ITT population) TEMSO-study
Danish: Table 1 - Væsentligste resultater (for den godkendte dosis, ITT-population) TEMSO-studiet
English: Each wallet is placed in a protective sleeve.
Danish: Hvert hylster er placeret i et beskyttende omslag.
English: TOWER-study
Danish: TOWER-studiet
English: However, this is most likely an underestimation since extensive organ distribution was observed in rats.
Danish: Dette er imidlertid sandsynligvis lavt sat, eftersom der observeredes en omfattende organdistribution hos rotter.
English: AUBAGIO may be taken with or without food.
Danish: AUBAGIO kan tages med eller uden mad.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports (PSURs)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: - you have an infection.
Danish: - Hvis du har en infektion.
English: This may lead to an additive effect on the immune system and caution is, therefore, indicated.
Danish: Dette kan medføre en additiv effekt på immunsystemet, og forsigtighed er derfor påkrævet.
English: No evidence of carcinogenicity was observed in rats and mice.
Danish: Der observeredes ingen tegn på karcinogenicitet hos rotter og mus.
English: The volume of distribution is 11 l after a single intravenous (IV) administration.
Danish: Distributionsvolumen er 11 l efter en enkelt intravenøs (i.v.)
English: Take your next dose at the scheduled time.
Danish: Tag den næste dosis som planlagt.
English: - you have weakness, numbness and pain in the hands and feet.
Danish: - Hvis du har svaghed, følelsesløshed og smerte i hænder og fødder.
English: Although human data are lacking, no effect on male and female fertility is anticipated.
Danish: Selv om der mangler humane data, forventes der ingen effekt på fertiliteten hos mænd og kvinder.
English: - you are due to have a specific blood test (calcium level).
Danish: - Hvis du skal have taget en særlig blodprøve (calciumniveau).
English: These elevations occurred mostly within the first 6 months of treatment.
Danish: Denne forhøjelse opstod for det meste inden for de første 6 måneder af behandlingen.
English: Effect on renal tubular functions
Danish: Virkning på renal tubulær funktion
English: Interference with determination of ionised calcium levels
Danish: Interferens med fastsættelse af ioniserede calciumniveauer