FrancophonIA/ELRC3.0 huggingface dataset:
English: Using your Bevespi Aerosphere inhaler: Step 1: Remove the cap from the mouthpiece (See Figure 6).
Danish: Sådan bruger du Bevespi Aerosphere inhalator: Trin 1: Fjern hætten fra mundstykket (se figur 6).
English: • Your Bevespi Aerosphere inhaler comes in a foil pouch that contains a drying packet (desiccant).
Danish: • Din Bevespi Aerosphere inhalator leveres i en foliepose, der indeholder en tørrepakke (tørremiddel).
English: This means that there are 110 puffs of medicine left in the pressurised container (See Figure 2b).
Danish: Det betyder, at der er 110 doser tilbage i trykbeholderen (se figur 2b).
English: Co-administration of Bevespi Aerosphere with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions (see section 4.4 and section 4.9).
Danish: Samtidig administration af Bevespi Aerosphere med andre lægemidler, der indeholder antikolinerge og/eller langtidsvirkende β2-adrenerge agonister, har ikke været undersøgt, og det anbefales ikke, da det kan forstærke bivirkningerne fra kendte muskarine antagonister til inhalation eller beta2-adrenerge agonister (se pkt.
English: Carton containing 1 inhaler with 120 actuations.
Danish: Karton indeholdende 1 inhalator med 120 pust.
English: Dose indicator
Danish: Dosisindikator
English: 1,2-distearoyl-sn-glycero-3-phosphocholine Calcium chloride
Danish: 1,2-distearoyl-sn-glycero-3-phosphocholin Calciumchlorid
English: Bevespi Aerosphere can be used at the recommended dose in patients with mild to moderate renal impairment.
Danish: Bevespi Aerosphere kan anvendes i den anbefalede dosis til patienter med mild til moderat nyreinsufficiens.
English: Pressurised inhalation, suspension (pressurised inhalation).
Danish: Inhalationsspray, suspension (inhalationsspray).
English: The terminal elimination half-life of formoterol following oral inhalation derived via population pharmacokinetics analysis was 13 hours.
Danish: Den terminale eliminationshalveringstid af formoterol efter oral inhalation var 13 timer, afledt via populationsfarmakokinetisk analyse.
English: The terminal elimination half-life of glycopyrronium following oral inhalation derived via population pharmacokinetics analysis was 15 hours.
Danish: Den terminale eliminationshalveringstid af glycopyrronium efter oral inhalation var 15 timer, afledt via populationsfarmakokinetisk analyse.
English: The inhaler is a pressurised metered dose inhaler, comprising an aluminium pressurised container with an attached dose indicator, supplied with a white plastic actuator body and mouthpiece with an orange dust cap. Each inhaler is individually packaged in a foil laminate pouch containing a desiccant sachet and packed into a carton.
Danish: Inhalatoren er en dosisinhalator under tryk, bestående af en aluminiumstrykbeholder med en vedhæftet dosisindikator, forsynet med et hvidt plasthylster og et mundstykke med en orange støvhætte.
English: SAC-TDI was a primary endpoint in PINNACLE 1 and PINNACLE 2 only From the Rescue Ventolin User Population in PINNACLE 4 A hierarchical statistical testing procedure was used in this study and this comparison was below a comparison that did not achieve statistical significance.
Danish: Fra populationen, der anvendte Ventoline anfaldsmedicin i PINNACLE 4 En hierarkisk statistisk testprocedure blev anvendt i dette studie, og sammenligningen var under en sammenligning, der ikke opnåede statistisk signifikans.
English: The parts of your Bevespi Aerosphere inhaler (See Figure 1):
Danish: Delene i Bevespi Aerosphere inhalator (se figur 1):
English: This means that there are 100 puffs of medicine left in the pressurised container (See Figure 2c).
Danish: Det betyder, at der er 100 doser tilbage i trykbeholderen (se figur 2c).
English: Figure 14 Step 1: Take the pressurised container out of the actuator (See Figure 15).
Danish: Trin 1: Tag trykbeholderen ud af plasthylsteret (se figur 15).
English: However, if it is nearly time for your next dose, skip the missed dose.
Danish: Tag din dosis så snart du husker det, men hvis det næsten er tid til din næste dosis, skal du springe den glemte dosis over.
English: This corresponds to a metered dose of glycopyrronium bromide 10.4 micrograms equivalent to 8.3 micrograms of glycopyrronium, and formoterol fumarate dihydrate 5.8 micrograms.
Danish: Dette svarer til en afmålt dosis glycopyrroniumbromid 10,4 mikrogram svarende til 8,3 mikrogram glycopyrronium og formoterolfumaratdihydrat 5,8 mikrogram.
English: Figure 12 Step 8: Replace the cap over the mouthpiece right away after use (See Figure 13).
Danish: Trin 8: Sæt hætten på mundstykket straks efter brug (se figur 13).
English: Bevespi Aerosphere is a pressurised inhalation, suspension.
Danish: Bevespi Aerosphere er en inhalationsspray, suspension.
English: Bevespi Aerosphere also showed improvements in peak FEV1 within 2 hours post-dose over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
Danish: Bevespi Aerosphere viste også forbedringer i peak FEV1 inden for 2 timer efter dosis over 24 uger i forhold til placebo, glycopyrronium og formoterol (p<0,0001) [se tabel 2].
English: Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Danish: Bevespi Aerosphere er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL) (se pkt.
English: o Do not use the Bevespi Aerosphere pressurised container with an actuator from any other inhaler.
Danish: o Brug ikke Bevespi Aerosphere trykbeholderen med et plasthylster fra nogen anden inhalator.
English: In patients with severe hepatic impairment, Bevespi Aerosphere should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Danish: Til patienter med svær leverinsufficiens bør Bevespi Aerosphere kun anvendes, hvis den forventede fordel opvejer den potentielle risiko (se pkt.
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk (see sections 4.4 and 5.2).
Danish: Hos patienter med svær nyreinsufficiens eller med dialysekrævende terminal nyresygdom, bør det kun anvendes, hvis den forventede fordel opvejer den potentielle risiko (se pkt.
English: 120 actuations
Danish: 120 pust
English: • you have kidney or liver problems
Danish: • du har nyre- eller leverlidelser
English: Bevespi Aerosphere is for inhalation use.
Danish: Bevespi Aerosphere er beregnet til inhalation.
English: If you forget to use Bevespi Aerosphere
Danish: Hvis du har glemt at bruge Bevespi Aerosphere
English: If you stop using Bevespi Aerosphere
Danish: Hvis du holder op med at bruge Bevespi Aerosphere
English: What you need to know before you use Bevespi Aerosphere
Danish: Det skal du vide, før du begynder at bruge Bevespi Aerosphere
English: Figure 16
Danish: Figur 16
English: Gastrointestinal disorders Dry mouth 2, Nausea
Danish: Mundtørhed 2, kvalme
English: o Do not use the Bevespi Aerosphere actuator with any other medicine.
Danish: o Brug ikke Bevespi Aerosphere plasthylsteret med nogen anden medicin.
English: If you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere.
Danish: Hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, før du bruger Bevespi Aerosphere.
English: INHALER LABEL (PRESSURISED CONTAINER)
Danish: INHALATORETIKET (TRYKBEHOLDER)
English: o Take the Bevespi Aerosphere inhaler out of the foil pouch.
Danish: o Tag Bevespi Aerosphere inhalatoren ud af folieposen.
English: Norflurane 1,2-distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Danish: Norfluran, 1,2-distearoyl-sn-glycero-3-phosphocholin og calciumchlorid.
English: In studies PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere showed improvements in trough FEV1 over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
Danish: I studierne PINNACLE 1, PINNACLE 2 og PINNACLE 4 viste Bevespi Aerosphere forbedringer i trough-FEV1 over 24 uger i forhold til placebo, glycopyrronium og formoterol (p<0,0001) [se tabel 2].
English: Figure 18
Danish: Figur 18
English: The pharmacokinetics of formoterol was best described by a two compartment disposition model with a first-order rate constant of absorption and linear elimination.The typical clearance (CL/F) of formoterol was 99 L/h.
Danish: Farmakokinetikken for formoterol blev bedst beskrevet ved en to-kammerdispositionsmodel med en 1. ordens konstant absorptionsrate og lineær elimination.
English: NAMES OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: However dizziness and nausea are common side effects which should be taken into account when driving or using machines.
Danish: Imidlertid bør det ved kørsel eller ved brug af maskiner tages i betragtning, at svimmelhed og kvalme er almindelige bivirkninger.
English: Administration of Bevespi Aerosphere to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the infant (see section 5.3).
Danish: Bevespi Aerosphere bør kun anvendes i ammeperioden, hvis fordelene for moderen opvejer de eventuelle risici for barnet (se pkt.
English: If you find it difficult breathing in and pressing the inhaler at the same time talk to your doctor or pharmacist.
Danish: Brug af Bevespi Aerosphere med en spacerenhed Hvis du har svært ved at trække vejret ind og trykke på inhalatoren samtidig, kan du tale med din læge eller apotekspersonalet, da du muligvis kan bruge en spacerenhed med din inhalator.
English: The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Danish: - Øvrige indholdsstoffer: norfluran, 1,2-distearoyl-sn-glycero-3-phosphocholin og calciumchlorid.
English: Figure 13
Danish: Figur 13
English: In PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere provided an improvement in disease-specific health-related quality of life, as indicated by a reduction in the St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks compared to placebo and glycopyrronium [see Table 2].
Danish: I PINNACLE 1, PINNACLE 2 og PINNACLE 4 viste Bevespi Aerosphere en forbedring af sygdomsspecifik sundhedsrelateret livskvalitet, som vist ved en reduktion i St George's Respiratory Questionnaire (SGRQ) total score over 24 uger sammenlignet med placebo og glycopyrronium [se tabel 2].
English: The mouthpiece is covered with an orange protective cap. Bevespi Aerosphere is supplied in a foil pouch that contains a drying packet (desiccant) and packed into a carton.
Danish: Bevespi Aerosphere leveres i en foliepose, der indeholder en tørrepakning (tørremiddel), og er pakket i en karton.
English: Figure 15
Danish: Figur 15
English: Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using Bevespi Aerosphere: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Danish: Stop med at bruge denne medicin og søg straks lægehjælp, da det kan være en alvorlig tilstand, som kaldes paradoks bronkospasme.
English: Preparing your Bevespi Aerosphere inhaler for use:
Danish: Forberedelse af Bevespi Aerosphere inhalator til brug :
English: Figure 11
Danish: Figur 11
English: Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension
Danish: Bevespi Aerosphere 7,2 mikrogram/5 mikrogram inhalationsspray, suspension.
English: In PINNACLE 4, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by TDI focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Danish: I PINNACLE 4 gav Bevespi Aerosphere forbedringer i åndenød som vist ved TDI fokal score over 24 uger sammenliget med placebo og glycopyrronium (se tabel 2).
English: Multipack: 360 actuations (3 packs of 120 actuations)
Danish: Inhalationsspray, suspension Multipakning: 360 pust (3 inhalatorer a 120 pust)
English: • agitation
Danish: • rastløshed
English: In PINNACLE 1 and PINNACLE 2, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by Self-administered Computerised Transitional Dyspnoea Index (SAC TDI) focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Danish: I PINNACLE 1 og PINNACLE 2 gav Bevespi Aerosphere forbedringer i åndenød som vist ved SAC TDI (Self-administered Computerised Transitional Dyspnoea Index) fokal score over 24 uger sammenlignet med placebo og glycopyrronium (se tabel 2).
English: Bevespi Aerosphere (N=551) vs glycopyrronium (N=474)
Danish: Bevespi Aerosphere (N=551) versus glycopyrronium (N=474)
English: Each single puff delivers a dose of 9 micrograms glycopyrronium bromide (equivalent to 7.2 micrograms of glycopyrronium), and 5 micrograms of formoterol fumarate dihydrate.
Danish: Hvert enkelt pust giver en dosis på 9 mikrogram glycopyrroniumbromid (svarende til 7,2 mikrogram glycopyrronium) og 5 mikrogram formoterolfumaratdihydrat.
English: Each single actuation (delivered dose, ex-actuator) contains glycopyrronium bromide 9 micrograms equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Danish: Hvert enkelt aktivering (leveret dosis, der forlader mundstykket) indeholder 9 mikrogram glycopyrroniumbromid svarende til 7,2 mikrogram glycopyrronium og 5 mikrogram formoterolfumaratdihydrat.
English: The estimated glycopyrronium Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 741 L, and 2990 L, respectively, via population pharmacokinetic analysis.
Danish: Via populationsfarmakokinetiske analyser er det estimerede glycopyrronium Vc/F (centralkammervolumen) og Vp1/F (periferkammervolumen) henholdsvis 741 l og 2990 l. Over koncentrationsområdet 2-500 nmol/l varierede plasmaproteinbindingen af glycopyrronium fra 43 % til 54 %.
English: Priming your Bevespi Aerosphere inhaler:
Danish: Klargør din Bevespi Aerosphere inhalator:
English: Other medicines and Bevespi Aerosphere
Danish: Brug af anden medicin sammen med Bevespi Aerosphere
English: Each single actuation contains glycopyrronium bromide equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Danish: Hvert enkelt pust indeholder glycopyrroniumbromid svarende til 7,2 mikrogram glycopyrronium og 5 mikrogram formoterolfumaratdihydrat.
English: How to clean your Bevespi Aerosphere inhaler:
Danish: Sådan rengøres din Bevespi Aerosphere inhalator:
English: This means that there are 120 puffs of medicine left in the pressurised container (See Figure 2a).
Danish: 120 doser tilbage i trykbeholderen (se figur 2a).
English: What Bevespi Aerosphere is and what it is used for What you need to know before you use Bevespi Aerosphere How to use Bevespi Aerosphere Possible side effects
Danish: Det skal du vide, før du begynder at bruge Bevespi Aerosphere Sådan skal du bruge Bevespi Aerosphere Bivirkninger
English: Over the concentration range of 10-500 nmol/L, plasma protein binding of formoterol ranged from 46% to 58%.
Danish: Via populationsfarmakokinetiske analyser er det estimerede formoterol Vc/F (centralkammervolumen) og Vp1/F (periferkammervolumen) henholdsvis 1030 l og 647 l. Over koncentrationsområdet 10-500 nmol/l varierede plasmaproteinbindingen af formoterol fra 46 % til 58 %.
English: However, because formoterol is primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver impairment.
Danish: Der er ikke udført farmakokinetiske studier af Bevespi Aerosphere hos patienter med leverinsufficiens, men fordi formoterol primært udskilles via hepatisk metabolisme, kan en øget eksponering forventes hos patienter med svær leverinsufficiens.
English: Do not store above 30 oC.
Danish: Må ikke opbevares ved temperaturer over 30 C.
English: INHALER LABEL (ACTUATOR)
Danish: INHALATORETIKET (PLASTHYLSTER)
English: Bevespi Aerosphere (N=526) vs formoterol fumarate (N=449)
Danish: Bevespi Aerosphere (N=526) versus formoterolfumarat (N=449)
English: Other pharmacodynamic interactions
Danish: Andre farmakodymaniske interaktioner
English: Aerosphere (N=551) vs placebo (N=235)
Danish: PINNACLE 4 Bevespi Aerosphere (N=551) versus placebo (N=235)
English: Bevespi Aerosphere (N=510) vs formoterol fumarate (N=437)
Danish: Bevespi Aerosphere (N=510) versus formoterolfumarat (N=437)
English: Bevespi
Danish: Pil
English: COPD exacerbations:
Danish: KOL-eksacerbationer:
English: Aerosphere (N=510) vs placebo (N=223)
Danish: PINNACLE 2 Bevespi Aerosphere (N=510) versus placebo (N=223)
English: How to use Bevespi Aerosphere
Danish: Sådan skal du bruge Bevespi Aerosphere
English: Aerosphere (N=526) vs placebo (N=219)
Danish: PINNACLE 1 Bevespi Aerosphere (N=526) versus placebo (N=219)
English: However,
Danish: NN:
English: Bevespi Aerosphere, 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate
Danish: Bevespi Aerosphere, 7,2 mikrogram/5 mikrogram inhalationsspray, suspension glycopyrronium/formoterolfumaratdihydrat
English: Bevespi Aerosphere (N=551) vs formoterol fumarate (N=480)
Danish: Bevespi Aerosphere (N=511) versus formoterolfumarat (N=480)
English: Bevespi Aerosphere 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate
Danish: Bevespi Aerosphere 7,2 mikrogram/5 mikrogram inhalationsspray, suspension glycopyrronium/formoterolfumaratdihydrat
English: 120 actuations (1 inhaler).
Danish: Inhalationsspray, suspension 120 pust (1 inhalator).
English: Take it as soon as you remember.
Danish: Den vil kun virke, så længe du bruger den.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret
English: 120 actuations (1 inhaler)
Danish: Inhalationsspray, suspension 120 pust (1 inhalator)
English: Mouthpiece
Danish: FOLIEPOSE
English: Cap
Danish: Hjerte
English: Pressurised container
Danish: Trykbeholder
English: The active substances are glycopyrronium and formoterol fumarate dihydrate.
Danish: Bevespi Aerosphere indeholder: - Aktive stoffer: glycopyrronium og formoterolfumaratdihydrat
English: System Organ Class
Danish: Immunsystemet
English: Dose indicator display window
Danish: Dosisindikatorvindue
English: However, these animal experimental results have little relevance to man. A slight increase in the incidence of uterine leiomyomas has been observed in rats and mice treated with formoterol; an effect which is considered to be a class-effect in rodents after long-term exposure to high doses of β2-adrenoreceptor agonists.
Danish: En lille stigning i forekomsten af uterine leiomyomer er set hos rotter og mus behandlet med formoterol.
English: Bevespi Aerosphere 7.2 mcg/5 mcg pressurised inhalation glycopyrronium/formoterol fumarate dihydrate Inhalation use
Danish: Bevespi Aerosphere 7,2 mikrog/5 mikrog inhalationsspray glycopyrronium/formoterolfumaratdihydrat Til inhalation
English: oC.
Danish: Hætte
English: FOIL POUCH
Danish: Mave-tarm-kanalen
English: The diluted solution should be taken immediately.
Danish: Den fortyndede opløsning bør straks tages.
English: In some cases, paradoxical CNS stimulation has been reported.
Danish: I nogle tilfælde er der rapporteret om paradoksal stimulation af CNS.
English: The terminal half-life is approximately 10 hours.
Danish: Den terminale halveringstid er ca. 10 timer.
English: The following indications were agreed upon:
Danish: Man blev enige om følgende indikationer:
English: Nevertheless, the administration of the medicine should be discontinued.
Danish: Ikke desto mindre skal behandlingen med medicinen ophøre.
English: The CHMP agreed with the harmonised text but maintained its lower age limit of 2 years.
Danish: CHMP var enig i den harmoniserede tekst, men fastholdt den lavere aldersgrænse på 2 år.
English: Should overdose occur, symptomatic or supportive treatment is recommended.
Danish: I tilfælde af overdosering anbefales symptomatisk eller støttende behandling.
English: The apparent volume of distribution is 0.50 l/kg.
Danish: Det tilsyneladende distributionsvolumen er 0,50 l/kg.
English: A list of Questions was adopted by the CHMP, highlighting the main areas of divergences.
Danish: CHMP vedtog en liste med spørgsmål, som fremhævede de væsentligste områder med afvigelser.
English: Dosage and frequency
Danish: Dosis og frekvens
English: About two third of the dose are excreted unchanged in urine.
Danish: Omkring to tredjedele af dosis udskilles uomdannet i urinen.
English: The corresponding section of the PL was revised accordingly.
Danish: Det tilsvarende afsnit af indlægssedlen blev revideret i overensstemmelse hermed.
English: As with other drugs, use of Zyrtec should be avoided in pregnant women.
Danish: Som med andre lægemidler, skal brug af Zyrtec til gravide kvinder undgås.
English: women for dl mg creatinine serum kg weight years age
Danish: kvinder for dl mg kreatinin serum kg vægt år alder
English: The drops should be poured in a spoon or diluted in water, and taken orally.
Danish: Dråberne bør hældes op på en ske eller fortyndes i vand og tages oralt.
English: SLO - 1001 Ljubljiana Slovenia
Danish: SLO - 1001 Ljubljiana Slovenien
English: Your doctor will then assess the severity and decide on any further measures that may be necessary.
Danish: Deres læge vil da bedømme alvorlighedensgraden og beslutte hvilke yderligere tiltag, der er nødvendige.
English: B - 2600 Berchem Belgium
Danish: B - 2600 Berchem Belgien
English: You should closely observe your response to the drug.
Danish: De skal nøje bemærke, hvordan De reagerer på lægemidlet.
English: Your doctor will then decide what measures, if any, should be taken.
Danish: Deres læge vil beslutte hvilke tiltag, hvis nogen, der skal tages.
English: The new dose will be determined by your Doctor.
Danish: Den nye dosis vil blive fastlagt af Deres læge.
English: A harmonized wording for age groups and relevant posology was agreed upon:
Danish: Man blev enige om en harmoniseret formulering for aldersgrupper og relevant dosering:
English: 04010 Borgo San Michele (LT) Italy
Danish: 04010 Borgo San Michele (LT) Italien
English: Plasma protein binding of cetirizine is 93 ± 0.3 %.
Danish: Proteinbindingen af cetirizin i plasma er 93 ± 0,3 %.
English: Kruczkowskiego, 8 00 - 380 Warszawa Poland
Danish: Kruczkowskiego, 8 00 - 380 Warszawa Polen
English: Nevertheless, precaution is recommended if alcohol is taken concomitantly.
Danish: Dog tilrådes forsigtighed ved samtidig indtagelse af alkohol.
English: Zyrtec is an antiallergic medication.
Danish: Zyrtec er et antiallergisk lægemiddel.
English: Like all medicines, Zyrtec can cause side effects, although not everybody gets them.
Danish: Zyrtec kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Read all of this leaflet carefully because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, Den indeholder vigtige informationer.
English: If dilution is used, it should be considered, especially for administration to children, that the volume of water to which the drops are added, needs to be adapted according to the quantity of water the patient is able to swallow.
Danish: Hvis der anvendes fortynding bør det, især ved administration hos børn, overvejes, at mængden af vand, som dråberne tilføres, skal tilpasses den mængde vand, patienten er i stand til at synke.
English: The MAH however informed the CHMP that due to the need for translating the old terms into the new ones, the process must start by a recoding of the source documents.
Danish: Indehaveren af markedsføringstilladelsen informerede imidlertid CHMP om, at fordi de gamle termer skal oversættes til de nye, skal processen indledes med en omkodning af kildedokumenterne.