FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with TOBI Podhaler in one or more subsets of the paediatric population in treatment of pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med TOBI Podhaler i alle undergrupper af den pædiatriske population i behandling mod lungeinfektioner/kolonisering, forårsaget af Pseudomonas aeruginosa, hos patienter med cystisk fibrose (se pkt.
English: Do not push the capsules through the foil.
Danish: Kapslerne må ikke presses igennem folien.
English: Contents of the pack and other information What TOBI Podhaler contains
Danish: Pakningsstørrelser og yderligere oplysninger TOBI Podhaler indeholder:
English: Adult patients tended to discontinue more frequently for tolerability reasons with TOBI Podhaler than with the nebuliser solution.
Danish: Voksne patienter havde af tolerabilitetsgrunde en tendens til oftere at afbryde med TOBI Podhaler end med inhalationsvæske til nebulisator, opløsning.
English: Do not push capsule through foil.
Danish: Kapslen må ikke presses igennem folien.
English: To puncture capsule, hold the inhaler with the mouthpiece down, press the button firmly with your thumb as far as it will go, then release the button.
Danish: Kapslen punkteres ved at holde inhalatoren med mundstykket nedad og trykke knappen hårdt ned med tommelfingeren, så langt den kan komme.
English: The apparent terminal half-life of tobramycin in serum after inhalation of a 112 mg single dose of TOBI Podhaler was approximately 3 hours in cystic fibrosis patients and consistent with the half-life of tobramycin after inhalation of tobramycin 300 mg/5 ml nebuliser solution (TOBI).
Danish: Den tilsyneladende terminale halveringtid for tobramycin i serum efter inhalation af en enkelt dosis TOBI Podhaler på 112 mg var ca. 3 timer hos patienter med cystisk fibrose og stemte overens med halveringstiden for tobramycin efter inhalation af tobramycin 300 mg/5 ml inhalationsvæske til nebulisator, opløsning (TOBI).
English: Inhale the capsule - 1st breath:
Danish: Inhaler kapslen - 1. åndedrag
English: Sputum from cystic fibrosis exhibits an inhibitory action on the local biological activity of inhaled aminoglycosides.
Danish: Ekspektorat fra patienter med cystisk fibrose udviser en hæmmende effekt på inhalerede aminoglykosiders lokale biologiske aktivitet.
English: In clinical studies, some patients on TOBI Podhaler therapy showed an increase in aminoglycoside minimum inhibitory concentrations (MIC) for P. aeruginosa isolates tested.
Danish: I kliniske studier er der hos nogle patienter i behandling med TOBI Podhaler fundet en stigning i aminoglykosids mindste hæmmende koncentrationer (MIC) for testede P. aeruginosa-isolater.
English: One capsule contains 28 mg tobramycin.
Danish: En kapsel indeholder 28 mg tobramycin.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter hvor alvorlige de er.
English: Each TOBI Podhaler capsule should be inhaled with two breath-hold manoeuvres and checked to ensure it is empty.
Danish: Hver TOBI Podhaler kapsel skal inhaleres ad to gange, hvor patienten holder vejret, og det skal kontrolleres, at kapslen er tom.
English: Clinical studies with inhaled tobramycin solution (TOBI) have shown a small increase in tobramycin, amikacin and gentamicin Minimum Inhibitory Concentrations for P. aeruginosa isolates tested.
Danish: Kliniske studier med tobramycin inhalationsvæske til nebulisator, opløsning (TOBI), har vist en lille stigning i tobramycin, amikacin og gentamicin mindste hæmmende koncentrationsværdier for testede P. aeruginosa isolater.
English: Do not use each inhaler and its case for longer than 1 week.
Danish: Hver inhalator + hylster må ikke bruges længere end 1 uge.
English: • Always hold the device with the mouthpiece pointing down when piercing the capsule.
Danish: • Hold altid inhalatoren, så mundstykket vender nedad, når kapslen perforeres.
English: If you experience any of these, stop taking TOBI Podhaler and tell your doctor straight away.
Danish: Hvis du oplever nogen af disse bivirkninger, skal du straks stoppe med TOBI Podhaler og sige det til din læge.
English: • Store the Podhaler device in its tightly closed case when not in use.
Danish: • Opbevar Podhaleren i det tæt tillukkede hylster, når den ikke er i brug.
English: TOBI Podhaler is administered by inhalation using the Podhaler device (see section 6.6 for detailed instructions for use).
Danish: TOBI Podhaler administreres via inhalation ved hjælp af Podhaleren (detaljeret brugsanvisning findes i pkt.
English: If this applies to you, tell your doctor without taking TOBI Podhaler.
Danish: Hvis dette gælder for dig, skal du sige det til lægen og ikke tage TOBI Podhaler.
English: • For inhalation use only.
Danish: • Kun til inhalation.
English: INSTRUCTIONS FOR USE OF THE PODHALER DEVICE
Danish: BRUGSANVISNING TIL PODHALER-INHALATOR
English: After inhalation of a 112 mg single dose (4 x 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, sputum Cmax of tobramycin was 1047 ± 1080 µg/g (mean ± SD).
Danish: Efter inhalation af en enkelt dosis TOBI Podhaler på 112 mg (4 x 28 mg kapsler) hos patienter med cystisk fibrose var ekspektorat-Cmax af tobramycin 1047 ± 1080 µg/g (middel ± SD).
English: Each weekly carton of TOBI Podhaler contains:
Danish: Hver TOBI Podhaler ugepakning indeholder:
English: Each hard capsule contains 28 mg tobramycin.
Danish: Hver hård kapsel indeholder 28 mg tobramycin.
English: Hearing loss and tinnitus were reported by patients in the TOBI Podhaler clinical studies (see section 4.8).
Danish: Nedsat hørelse og tinnitus er rapporteret hos patienter i kliniske studier med TOBI Podhaler (se pkt.
English: In a second open-label, multicentre study, patients received treatment with either TOBI Podhaler (112 mg) or tobramycin 300 mg/5 ml nebuliser solution (TOBI), administered twice daily for three cycles.
Danish: I det andet åbne, multicenterstudie fik patienterne behandling med enten TOBI Podhaler (112 mg) eller tobramycin 300 mg/5 ml inhalationsvæske til nebulisator, opløsning (TOBI), givet to gange dagligt i tre cyklusser.
English: Based on clinical trial data the inhalation powder TOBI Podhaler was associated with a higher reported rate of cough compared with tobramycin nebuliser solution (TOBI).
Danish: Baseret på data fra kliniske studier var TOBI Podhaler inhalationspulver forbundet med en højere rapporteringshyppighed af hoste sammenlignet med tobramycin inhalationsvæske til nebulisator, opløsning (TOBI).
English: Capsule card
Danish: Kapselkort
English: Please also refer to nephrotoxicity information in section 4.4.
Danish: Der henvises desuden til oplysningerne vedrørende nefrotoksicitet i pkt.
English: 10 and 11.
Danish: 7, 8, 9, 10 og 11.
English: Use capsule immediately after removal from blister.
Danish: Kapslen skal bruges straks, når den er taget ud af kapselkortet.
English: Inhalation powder, hard capsules Multipack: 448 capsules (2 packs of 224 + 5 inhalers)
Danish: Inhalationspulver, hårde kapsler Multipakning: 448 kapsler (2 pakninger med 224 kapsler + 5 inhalatorer)
English: Ask your pharmacist how to dispose of medicines and inhalers no longer required.
Danish: Spørg på apoteket, hvordan du skal aflevere medicinrester og brugte inhalatorer.
English: As tobramycin is not metabolised, an effect of hepatic impairment on the exposure to tobramycin is not expected.
Danish: Da tobramycin ikke metaboliseres, forventes nedsat leverfunktion ikke at påvirke eksponeringen af tobramycin.
English: • Never blow into the mouthpiece of the device.
Danish: • Pust aldrig ind i inhalatorens mundstykke.
English: • Just before use, remove the inhaler from its case by holding the base and twisting off the top of the case in an anti-clockwise direction.
Danish: • Lige før den skal bruges, tages inhalatoren ud af hylstret: Hold på underdelen, og drej overdelen mod uret.
English: • Take a few normal breaths away from the inhaler.
Danish: • Træk vejret normalt et par gange, væk fra inhalatoren.
English: • Replace the mouthpiece and repeat steps 8,9 and 10.
Danish: • Sæt mundstykket på igen, og gentag trin 8, 9 og 10.
English: After inhalation of a 112 mg single dose (4 x 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, the maximum serum concentration (Cmax) of tobramycin was 1.02 ± 0.53 μg/ml (mean ± SD) and the median time to reach the peak concentration (Tmax) was one hour.
Danish: Efter inhalation af en enkelt dosis på 112 mg (4 x 28 mg kapsler) af TOBI Podhaler hos patienter med cystisk fibrose var den maksimale serumkoncentration (Cmax) af tobramycin 1,02 ± 0,53 μg/ml (middel ± SD), og mediantiden for opnåelse af den maksimale koncentration (Tmax) var én time.
English: Contains 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride and sulphuric acid (for pH adjustment).
Danish: Indeholder 1,2-distearoyl-sn-glycero-3-phosphocholin (DSPC), calciumchlorid og svovlsyre (til pHjustering).
English: Tél: +33 1 56 64 10 70
Danish: Mylan Medical SAS Tél: +33 1 56 64 10 70
English: A numerically lower response in patients aged ≥20 years was observed: the change from baseline FEV1 observed in the patients aged ≥20 years was smaller (0.3% with TOBI Podhaler and 0.9% with TOBI nebuliser solution).
Danish: Ændringen fra baseline FEV1 hos patienter på ≥ 20 år var mindre (0,3 % med TOBI Podhaler og 0,9 % med TOBI inhalationsvæske til nebulisator, opløsning).
English: • When you are ready, take your 2nd breath by repeating
Danish: • Når du er klar, inhalerer du for anden gang fra den samme kapsel ved at gentage trin 8.
English: 56 inhalation powder, hard capsules and 1 inhaler (weekly pack) 224 (4 x 56) inhalation powder, hard capsules and 5 inhalers (monthly multipack) 448 (8 x 56) inhalation powder, hard capsules and 10 inhalers (2 x monthly multipack wrapped in foil)
Danish: 56 inhalationspulver i kapsler og 1 inhalator (ugepakning) 224 (4 x 56) inhalationspulver i kapsler og 5 inhalatorer (multipakning til en måned) 448 (8 x 56) inhalationspulver i kapsler og 10 inhalatorer (2 x multipakning til en måned emballeret i folie)
English: Please discard inhaler and its case after 1 week of use.
Danish: Kasser inhalator + hylster efter 1 uges brug.
English: Inhalation powder, hard capsules Multipack: 224 capsules (4 packs of 56 + 1 inhaler) + reserve inhaler
Danish: Inhalationspulver, hårde kapsler Multipakning: 224 kapsler (4 pakninger med 56 kapsler + 1 inhalator) + reserveinhalator
English: If the capsule appears to be unpunctured, place it back into the inhaler, press the button firmly as far as it goes and take another two inhalations from the capsule.
Danish: Undersøg kapslen igen Hvis kapslen ikke er punkteret, sættes den tilbage i inhalatoren, knappen trykkes hårdt så langt ind, den kan komme, og der tages endnu to inhalationer fra kapslen.
English: Sputum concentrations
Danish: Ekspektoratkoncentrationer
English: See also section 5.1 for the profile of response of TOBI Podhaler compared to tobramycin nebuliser solution.
Danish: 5.1 for responsprofilen af TOBI Podhaler sammenlignet med tobramycin inhalationsvæske til nebulisator, opløsning.
English: • The other ingredients are DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), calcium chloride, sulfuric acid (for pH adjustment).
Danish: • Øvrige indholdsstoffer: 1,2-distearoyl-sn-glycero-3-phosphocholin (DSPC), calciumchlorid og svovlsyre (til pH-justering).
English: FOUR capsules are required for ONE complete dose.
Danish: EN fuld dosis består af FIRE kapsler.
English: Basic instructions for use are given below, more detailed instructions are available from the patient leaflet.
Danish: Indlægssedlen indeholder en mere detaljeret vejledning.
English: What you need to know before you take TOBI Podhaler Do not take TOBI Podhaler
Danish: Det skal du vide, før du begynder at tage TOBI Podhaler Tag ikke TOBI Podhaler
English: • unusual difficulty in breathing with wheezing or coughing, chest tightness
Danish: • usædvanlig vanskeligt ved at trække vejret med pibende vejrtrækning, hoste eller trykken for brystet
English: 224 (4 x 56) capsules and 5 inhalers (monthly multipack) 448 (8 x 56) capsules and 10 inhalers (2 x monthly multipack wrapped in foil) Not all pack sizes may be marketed.
Danish: 224 (4 x 56) kapsler og 5 inhalatorer (multipakning til en måned) 448 (8 x 56) kapsler og 10 inhalatorer (2x multipakning til en måned i folieomslag)
English: Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular dysfunction.
Danish: Der bør udvises forsigtighed ved ordination af TOBI Podhaler til patienter med kendt eller mistænkt auditiv eller vestibulær dysfunktion.
English: • Set the top of the case aside.
Danish: • Læg hylstrets overdel til side.
English: If any of these apply to you, tell your doctor before taking TOBI Podhaler.
Danish: Hvis noget at dette gælder for dig, skal du sige det til lægen, før du tager TOBI Podhaler.
English: For safety results see section 4.8
Danish: For resultater angående sikkerheden se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONTHLY INTERMEDIATE CARTON OF MULTIPACK COMPRISING 2 MONTHLY PACKS, EACH CONTAINING 4 WEEKLY PACKS) (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MÅNEDLIG MELLEMEMBALLAGE TIL MULTIPAKNING BESTÅENDE AF 2 MÅNEDSPAKNINGER, DER HVER INDEHOLDER 4 UGEPAKNINGER (UDEN BLÅ BOKS)
English: (To be displayed only on the inner lid of the intermediate carton of multipack) Read the package leaflet before use.
Danish: (Kun indvendigt på låget af multipakningens mellemkarton) Læs indlægssedlen inden brug.
English: When they are given by an injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such as deafness.
Danish: Tobramycin og andre aminoglykosid-antibiotika kan, hvis de gives som injektioner, medføre skade på et ufødt barn, fx døvhed.
English: Store the Podhaler device in its tightly closed case when not in use.
Danish: Opbevar Podhaleren i det tæt tillukkede hylster, når den ikke bruges.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL COMPRISING 2 MONTHLY PACKS, EACH CONTAINING 4 WEEKLY PACKS) (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OMSLAGSETIKET TIL MULTIPAKNINGER MED OMSLAG AF FOLIE BESTÅENDE AF 2 MÅNEDSPAKNINGERM DER HVER INDEHOLDER 4 UGEPAKNINGER (INKLUSIVE BLÅ BOKS)
English: • Peel back the foil from the capsule card to reveal one capsule only.
Danish: • Træk folien af kapselkortet, så kun en enkelt kapsel kommer til syne.
English: In the placebo-controlled study with TOBI Podhaler, the adverse reactions for which reported frequency was higher with TOBI Podhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.
Danish: I det placebo-kontrollerede studie med TOBI Podhaler var faryngolaryngeale smerter, dysgeusi og dysfoni de bivirkninger, der rapporteredes hyppigere med TOBI Podhaler end med placebo.
English: TOBI Podhaler 28 mg inhalation powder, hard capsules tobramycin
Danish: TOBI Podhaler 28 mg inhalationspulver, hårde kapsler tobramycin
English: Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction.
Danish: Der bør udvises forsigtighed ved ordination af TOBI Podhaler til patienter med kendt eller mistænkt renal dysfunktion.
English: This includes monitoring of serum concentrations of tobramycin.
Danish: Monitoreringen skal også omfatte serumkoncentrationer af tobramycin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WEEKLY INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE UGENTLIG MELLEMEMBALLAGE TIL MULTIPAKNING (UDEN BLÅ BOKS)
English: See also section 4.2 and “Monitoring of serum tobramycin concentrations” below.
Danish: 4.2 og “Monitorering af serumkoncentrationer af tobramycin” nedenfor.
English: Continue taking TOBI Podhaler as your doctor tells you.
Danish: Fortsæt med at tage TOBI Podhaler efter lægens anvisning.
English: For use only with the inhaler provided in the pack.
Danish: Må kun bruges sammen med inhalatoren i pakningen.
English: (To be displayed only on the inner lid of the outer carton of multipack) Read the package leaflet before use.
Danish: (Kun indvendigt på låget af multipakningens yderkarton) Læs indlægssedlen før brug.
English: Other medicines and TOBI Podhaler
Danish: Brug af anden medicin sammen med TOBI Podhaler
English: In the active-controlled open-label study, patients aged 20 years and older tended to discontinue more frequently with TOBI Podhaler than with the nebuliser solution; discontinuations due to adverse events accounted for about half of the discontinuations with each formulation.
Danish: I det aktivt-kontrolleret ublindede studie havde patienter i alderen 20 år og ældre en tendens til at afbryde behandlingen oftere med TOBI Podhaler end med inhalationsvæske til nebulisator, opløsning.
English: See also “Monitoring of serum tobramycin concentrations” above.
Danish: Se også “Monitorering af serumkoncentrationer af tobramycin” ovenfor.
English: Always store inhaler in its case.
Danish: Inhalatoren skal altid opbevares i hylsteret.
English: • Hold the inhaler with the mouthpiece pointing down
Danish: • Hold inhalatoren, så mundstykket vender nedad.
English: • Only use the inhaler contained in this pack.
Danish: • Brug kun den Podhaler, der ligger i pakningen.
English: Keep it dry and store it in its case.
Danish: Den må ikke blive våd og skal opbevares i hylstret.
English: Taking your capsules at the same time each day will help you remember when to take them.
Danish: Hvis du tager kapslerne på samme tidspunkt hver dag, vil du lettere kunne huske, hvornår du skal tage dem. Inhaler indholdet af 4 kapsler to gange daglig som følger:
English: In a 6-month (3 treatment cycles) study of TOBI Podhaler versus tobramycin nebuliser solution, which included a majority of tobramycin-experienced adult patients with chronic pulmonary P. aeruginosa infection, the suppression of sputum P. aeruginosa density was similar across age groups in both arms; however the increase from baseline FEV1 was larger in younger age groups (6 - <20) than in the adult subgroup (20 years and older) in both arms.
Danish: I et studie med TOBI Podhaler sammenlignet med tobramycin inhalationsvæske til nebulisator, opløsning, af 6 måneders varighed (3 behandlingscyklusser), hvori et flertal var tobramycin-erfarne voksne patienter med kronisk pulmonal P. aeruginosa-infektion, var suppressionen af densiteten af P. aeruginosa i ekspektorat omtrent ens i alle aldersgrupper i begge arme.
English: See also “Monitoring of serum tobramycin concentrations” below.
Danish: Se også “Monitorering af serumkoncentrationer af tobramycin” nedenfor.
English: ON TOBI Podhaler OFF TOBI Podhaler
Danish: MED TOBI Podhaler UDEN TOBI Podhaler
English: Unscrew mouthpiece (1) and remove the capsule from the chamber (2).
Danish: 10. Skru mundstykket af (1), og tag kapslen ud af kammeret
English: TOBI Podhaler 28 mg inhalation powder, hard capsules
Danish: TOBI Podhaler 28 mg inhalationspulver i kapsler
English: • Stand the inhaler upright in the base of the case.
Danish: • Anbring inhalatoren oprejst i hylstrets underdel.
English: Nephrotoxicity was not observed during TOBI Podhaler clinical studies.
Danish: Nefrotoksicitet er ikke observeret i kliniske studier med TOBI Podhaler.
English: Inside your TOBI Podhaler weekly pack
Danish: I din TOBI Podhaler ugepakning
English: (To be displayed only on the inner lid of the outer carton of unit pack) Read the package leaflet before use.
Danish: (Kun indvendigt på låget af enkeltpakningens yderkarton) Læs indlægssedlen inden brug.
English: Separate the morning and evening doses from the capsule card. Peel back the foil from the capsule card to reveal one TOBI Podhaler capsule and remove it from the card.
Danish: Træk folien tilbage fra kapselkortet, så der kommer én TOBI Podhaler kapsel til syne, og tag kapslen ud.
English: Not applicable
Danish: Utilpashed
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON TIL MULTIPAKNING (INKLUSIVE BLÅ BOKS)
English: • Do not swallow TOBI Podhaler capsules.
Danish: • TOBI Podhaler kapslerne må ikke synkes.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF UNIT PACK (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON TIL ENKELTSPAKNING (INKLUSIV BLUE BOKS)
English: • Hold the body of the inhaler and unscrew the mouthpiece in an anti-clockwise direction.
Danish: • Hold om selve inhalatoren, og skru mundstykket af ved at dreje mod uret.
English: Storage case
Danish: Opbevaring
English: monthly multipack
Danish: multipakning til en måned
English: How much TOBI Podhaler to take
Danish: Så meget TOBI Podhaler skal du tage
English: At the end of a 4-week dosing cycle of TOBI Podhaler (112 mg twice daily), maximum serum concentration of tobramycin 1 hour after dosing was 1.99 ± 0.59 µg/ml.
Danish: Omfanget af den systemiske eksponering (AUC) var også ens for en dosis TOBI Podhaler på 112 mg og en dosis tobramycin inhalationsvæske til nebulisator, opløsning, på 300 mg. Ved udgangen af en fire ugers doseringscyklus med TOBI Podhaler (112 mg to gange dagligt) var den maksimale serumkoncentration af tobramycin 1 time efter dosering 1,99 ± 0,59 µg/ml.
English: What TOBI Podhaler is and what it is used for What you need to know before you take TOBI Podhaler How to take TOBI Podhaler Possible side effects
Danish: Det skal du vide, før du begynder at tage TOBI Podhaler Sådan skal du tage TOBI Podhaler Bivirkninger
English: Do not swallow capsules.
Danish: Kapslerne må ikke synkes.
English: Holding the body of the inhaler, unscrew and remove the mouthpiece from the inhaler body.
Danish: Hold om selve inhalatoren og skru mundstykket af.
English: Table 1 Adverse reactions Adverse reactions
Danish: Tabel 1 Bivirkninger Bivirkninger
English: If it is empty, discard the capsule.
Danish: Hvis den er tom, smides den ud.
English: Tabulated summary of adverse reactions
Danish: Resumé for bivirkninger i tabelform
English: How to store TOBI Podhaler Contents of the pack and other information Instructions for use with the Podhaler device (overleaf)
Danish: Pakningsstørrelser og yderligere oplysninger Brugsanvisning til Podhaler-inhalator (næste side)
English: • Nosebleed
Danish: • Næseblod
English: See also information on clinical benefit and tolerability in sections 4.4, 4.8 and 5.1.
Danish: Se også oplysninger om den kliniske effekt og tolerabilitet i pkt.
English: • Screw the mouthpiece on firmly until it stops.
Danish: • Drej hylstrets overdel med uret, indtil det er lukket tæt.
English: Rales
Danish: Rallelyde
English: • Disturbed sense of taste.
Danish: • Smagsforstyrrelser
English: In comparison, after inhalation of a single 300 mg dose of tobramycin nebuliser solution (TOBI), sputum Cmax was 737.3 ± 1028.4 µg/g.
Danish: Til sammenligning var ekspektorat Cmax 737,3 ± 1028,4 µg/g efter inhalation af en enkelt dosis tobramycin inhalationsvæske til nebulisator, opløsning (TOBI), på 300 mg. Variationen i de farmakokinetiske parametre var større i ekspektorat end i serum.
English: Once removed from the capsule card (blister), a capsule should be used immediately.
Danish: Kapslerne skal bruges, så snart de er taget ud af kapselkortet (blister).
English: When to take TOBI Podhaler
Danish: Hvornår TOBI Podhaler skal tages
English: How to take TOBI Podhaler
Danish: Sådan skal du tage TOBI Podhaler
English: In comparison, after inhalation of a single dose of tobramycin 300 mg/5 ml nebuliser solution (TOBI), Cmax was 1.04 ± 0.58 µg/ml and median Tmax was one hour.
Danish: Til sammenligning var Cmax 1,04 ± 0,58 µg/ml og median-Tmax én time efter inhalation af en enkelt dosis tobramycin 300 mg/5 ml inhalationsvæske til nebulisator, opløsning (TOBI).
English: How TOBI Podhaler works
Danish: Sådan virker TOBI Podhaler