natgillin/translations-raw huggingface dataset:
Bevespi Aerosphere kan anvendes i den anbefalede dosis til patienter med mild til moderat nyreinsufficiens. 
Bevespi Aerosphere can be used at the recommended dose in patients with mild to moderate renal impairment.
Inhalationsspray, suspension (inhalationsspray). 
Pressurised inhalation, suspension (pressurised inhalation).
Den terminale eliminationshalveringstid af formoterol efter oral inhalation var 13 timer, afledt via populationsfarmakokinetisk analyse. 
The terminal elimination half-life of formoterol following oral inhalation derived via population pharmacokinetics analysis was 13 hours.
Den terminale eliminationshalveringstid af glycopyrronium efter oral inhalation var 15 timer, afledt via populationsfarmakokinetisk analyse. 
The terminal elimination half-life of glycopyrronium following oral inhalation derived via population pharmacokinetics analysis was 15 hours.
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. 
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.
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. 
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.
Delene i Bevespi Aerosphere inhalator (se figur 1): 
The parts of your Bevespi Aerosphere inhaler (See Figure 1):
Det betyder, at der er 100 doser tilbage i trykbeholderen (se figur 2c). 
This means that there are 100 puffs of medicine left in the pressurised container (See Figure 2c).
Trin 1: Tag trykbeholderen ud af plasthylsteret (se figur 15). 
Figure 14 Step 1: Take the pressurised container out of the actuator (See Figure 15).
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. 
However, if it is nearly time for your next dose, skip the missed dose.
Dette svarer til en afmålt dosis glycopyrroniumbromid 10,4 mikrogram svarende til 8,3 mikrogram glycopyrronium og formoterolfumaratdihydrat 5,8 mikrogram. 
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.
Trin 8: Sæt hætten på mundstykket straks efter brug (se figur 13). 
Figure 12 Step 8: Replace the cap over the mouthpiece right away after use (See Figure 13).
Bevespi Aerosphere er en inhalationsspray, suspension. 
Bevespi Aerosphere is a pressurised inhalation, suspension.
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]. 
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].
Bevespi Aerosphere er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL) (se pkt. 
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).
o Brug ikke Bevespi Aerosphere trykbeholderen med et plasthylster fra nogen anden inhalator. 
o Do not use the Bevespi Aerosphere pressurised container with an actuator from any other inhaler.
Til patienter med svær leverinsufficiens bør Bevespi Aerosphere kun anvendes, hvis den forventede fordel opvejer den potentielle risiko (se pkt. 
In patients with severe hepatic impairment, Bevespi Aerosphere should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Hos patienter med svær nyreinsufficiens eller med dialysekrævende terminal nyresygdom, bør det kun anvendes, hvis den forventede fordel opvejer den potentielle risiko (se pkt. 
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).
120 pust 
120 actuations
• du har nyre- eller leverlidelser 
• you have kidney or liver problems
Bevespi Aerosphere er beregnet til inhalation. 
Bevespi Aerosphere is for inhalation use.
Hvis du har glemt at bruge Bevespi Aerosphere 
If you forget to use Bevespi Aerosphere
Hvis du holder op med at bruge Bevespi Aerosphere 
If you stop using Bevespi Aerosphere
Det skal du vide, før du begynder at bruge Bevespi Aerosphere 
What you need to know before you use Bevespi Aerosphere
Figur 16 
Figure 16
Mundtørhed 2, kvalme 
Gastrointestinal disorders Dry mouth 2, Nausea
o Brug ikke Bevespi Aerosphere plasthylsteret med nogen anden medicin. 
o Do not use the Bevespi Aerosphere actuator with any other medicine.
Hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, før du bruger Bevespi Aerosphere. 
If you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere.
INHALATORETIKET (TRYKBEHOLDER) 
INHALER LABEL (PRESSURISED CONTAINER)
o Tag Bevespi Aerosphere inhalatoren ud af folieposen. 
o Take the Bevespi Aerosphere inhaler out of the foil pouch.
Norfluran, 1,2-distearoyl-sn-glycero-3-phosphocholin og calciumchlorid. 
Norflurane 1,2-distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
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]. 
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].
Figur 18 
Figure 18
Farmakokinetikken for formoterol blev bedst beskrevet ved en to-kammerdispositionsmodel med en 1. ordens konstant absorptionsrate og lineær elimination. 
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.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN 
NAMES OF THE MARKETING AUTHORISATION HOLDER
Imidlertid bør det ved kørsel eller ved brug af maskiner tages i betragtning, at svimmelhed og kvalme er almindelige bivirkninger. 
However dizziness and nausea are common side effects which should be taken into account when driving or using machines.
Bevespi Aerosphere bør kun anvendes i ammeperioden, hvis fordelene for moderen opvejer de eventuelle risici for barnet (se pkt. 
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).
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. 
If you find it difficult breathing in and pressing the inhaler at the same time talk to your doctor or pharmacist.
- Øvrige indholdsstoffer: norfluran, 1,2-distearoyl-sn-glycero-3-phosphocholin og calciumchlorid. 
The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Figur 13 
Figure 13
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]. 
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].
Bevespi Aerosphere leveres i en foliepose, der indeholder en tørrepakning (tørremiddel), og er pakket i en karton. 
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.
Stop med at bruge denne medicin og søg straks lægehjælp, da det kan være en alvorlig tilstand, som kaldes paradoks bronkospasme. 
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.
Forberedelse af Bevespi Aerosphere inhalator til brug : 
Preparing your Bevespi Aerosphere inhaler for use:
Bevespi Aerosphere 7,2 mikrogram/5 mikrogram inhalationsspray, suspension. 
Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension
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). 
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).
Inhalationsspray, suspension Multipakning: 360 pust (3 inhalatorer a 120 pust) 
Multipack: 360 actuations (3 packs of 120 actuations)
• rastløshed 
• agitation
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). 
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).
Bevespi Aerosphere (N=551) versus glycopyrronium (N=474) 
Bevespi Aerosphere (N=551) vs glycopyrronium (N=474)
Hvert enkelt pust giver en dosis på 9 mikrogram glycopyrroniumbromid (svarende til 7,2 mikrogram glycopyrronium) og 5 mikrogram formoterolfumaratdihydrat. 
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.
Hvert enkelt aktivering (leveret dosis, der forlader mundstykket) indeholder 9 mikrogram glycopyrroniumbromid svarende til 7,2 mikrogram glycopyrronium og 5 mikrogram formoterolfumaratdihydrat. 
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.
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 %. 
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.
Klargør din Bevespi Aerosphere inhalator: 
Priming your Bevespi Aerosphere inhaler:
Brug af anden medicin sammen med Bevespi Aerosphere 
Other medicines and Bevespi Aerosphere
Hvert enkelt pust indeholder glycopyrroniumbromid svarende til 7,2 mikrogram glycopyrronium og 5 mikrogram formoterolfumaratdihydrat. 
Each single actuation contains glycopyrronium bromide equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Sådan rengøres din Bevespi Aerosphere inhalator: 
How to clean your Bevespi Aerosphere inhaler:
120 doser tilbage i trykbeholderen (se figur 2a). 
This means that there are 120 puffs of medicine left in the pressurised container (See Figure 2a).
Det skal du vide, før du begynder at bruge Bevespi Aerosphere Sådan skal du bruge Bevespi Aerosphere Bivirkninger 
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
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 %. 
Over the concentration range of 10-500 nmol/L, plasma protein binding of formoterol ranged from 46% to 58%.
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. 
However, because formoterol is primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver impairment.
Må ikke opbevares ved temperaturer over 30 C. 
Do not store above 30 oC.
INHALATORETIKET (PLASTHYLSTER) 
INHALER LABEL (ACTUATOR)
Bevespi Aerosphere (N=526) versus formoterolfumarat (N=449) 
Bevespi Aerosphere (N=526) vs formoterol fumarate (N=449)
Andre farmakodymaniske interaktioner 
Other pharmacodynamic interactions
PINNACLE 4 Bevespi Aerosphere (N=551) versus placebo (N=235) 
Aerosphere (N=551) vs placebo (N=235)
Bevespi Aerosphere (N=510) versus formoterolfumarat (N=437) 
Bevespi Aerosphere (N=510) vs formoterol fumarate (N=437)
Pil 
Bevespi
KOL-eksacerbationer: 
COPD exacerbations:
PINNACLE 2 Bevespi Aerosphere (N=510) versus placebo (N=223) 
Aerosphere (N=510) vs placebo (N=223)
Sådan skal du bruge Bevespi Aerosphere 
How to use Bevespi Aerosphere
PINNACLE 1 Bevespi Aerosphere (N=526) versus placebo (N=219) 
Aerosphere (N=526) vs placebo (N=219)
Bevespi Aerosphere, 7,2 mikrogram/5 mikrogram inhalationsspray, suspension glycopyrronium/formoterolfumaratdihydrat 
Bevespi Aerosphere, 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate
Bevespi Aerosphere (N=511) versus formoterolfumarat (N=480) 
Bevespi Aerosphere (N=551) vs formoterol fumarate (N=480)
Bevespi Aerosphere 7,2 mikrogram/5 mikrogram inhalationsspray, suspension glycopyrronium/formoterolfumaratdihydrat 
Bevespi Aerosphere 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate
Inhalationsspray, suspension 120 pust (1 inhalator). 
120 actuations (1 inhaler).
Den vil kun virke, så længe du bruger den. 
Take it as soon as you remember.
Denne indlægsseddel blev senest ændret 
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Inhalationsspray, suspension 120 pust (1 inhalator) 
120 actuations (1 inhaler)
FOLIEPOSE 
Mouthpiece
Hjerte 
Cap
Trykbeholder 
Pressurised container
Bevespi Aerosphere indeholder: - Aktive stoffer: glycopyrronium og formoterolfumaratdihydrat 
The active substances are glycopyrronium and formoterol fumarate dihydrate.
Immunsystemet 
System Organ Class
Dosisindikatorvindue 
Dose indicator display window
En lille stigning i forekomsten af uterine leiomyomer er set hos rotter og mus behandlet med formoterol. 
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.
Bevespi Aerosphere 7,2 mikrog/5 mikrog inhalationsspray glycopyrronium/formoterolfumaratdihydrat Til inhalation 
Bevespi Aerosphere 7.2 mcg/5 mcg pressurised inhalation glycopyrronium/formoterol fumarate dihydrate Inhalation use
Hætte 
oC.
Mave-tarm-kanalen 
FOIL POUCH
Den fortyndede opløsning bør straks tages. 
The diluted solution should be taken immediately.
I nogle tilfælde er der rapporteret om paradoksal stimulation af CNS. 
In some cases, paradoxical CNS stimulation has been reported.
Den terminale halveringstid er ca. 10 timer. 
The terminal half-life is approximately 10 hours.
Man blev enige om følgende indikationer: 
The following indications were agreed upon:
Ikke desto mindre skal behandlingen med medicinen ophøre. 
Nevertheless, the administration of the medicine should be discontinued.
CHMP var enig i den harmoniserede tekst, men fastholdt den lavere aldersgrænse på 2 år. 
The CHMP agreed with the harmonised text but maintained its lower age limit of 2 years.
I tilfælde af overdosering anbefales symptomatisk eller støttende behandling. 
Should overdose occur, symptomatic or supportive treatment is recommended.
Det tilsyneladende distributionsvolumen er 0,50 l/kg. 
The apparent volume of distribution is 0.50 l/kg.
CHMP vedtog en liste med spørgsmål, som fremhævede de væsentligste områder med afvigelser. 
A list of Questions was adopted by the CHMP, highlighting the main areas of divergences.
Dosis og frekvens 
Dosage and frequency
Omkring to tredjedele af dosis udskilles uomdannet i urinen. 
About two third of the dose are excreted unchanged in urine.
Det tilsvarende afsnit af indlægssedlen blev revideret i overensstemmelse hermed. 
The corresponding section of the PL was revised accordingly.
Som med andre lægemidler, skal brug af Zyrtec til gravide kvinder undgås. 
As with other drugs, use of Zyrtec should be avoided in pregnant women.
kvinder for dl mg kreatinin serum kg vægt år alder 
women for dl mg creatinine serum kg weight years age
Dråberne bør hældes op på en ske eller fortyndes i vand og tages oralt. 
The drops should be poured in a spoon or diluted in water, and taken orally.
SLO - 1001 Ljubljiana Slovenien 
SLO - 1001 Ljubljiana Slovenia
Deres læge vil da bedømme alvorlighedensgraden og beslutte hvilke yderligere tiltag, der er nødvendige. 
Your doctor will then assess the severity and decide on any further measures that may be necessary.
B - 2600 Berchem Belgien 
B - 2600 Berchem Belgium
De skal nøje bemærke, hvordan De reagerer på lægemidlet. 
You should closely observe your response to the drug.
Deres læge vil beslutte hvilke tiltag, hvis nogen, der skal tages. 
Your doctor will then decide what measures, if any, should be taken.
Den nye dosis vil blive fastlagt af Deres læge. 
The new dose will be determined by your Doctor.
Man blev enige om en harmoniseret formulering for aldersgrupper og relevant dosering: 
A harmonized wording for age groups and relevant posology was agreed upon:
04010 Borgo San Michele (LT) Italien 
04010 Borgo San Michele (LT) Italy
Proteinbindingen af cetirizin i plasma er 93 ± 0,3 %. 
Plasma protein binding of cetirizine is 93 ± 0.3 %.
Kruczkowskiego, 8 00 - 380 Warszawa Polen 
Kruczkowskiego, 8 00 - 380 Warszawa Poland
Dog tilrådes forsigtighed ved samtidig indtagelse af alkohol. 
Nevertheless, precaution is recommended if alcohol is taken concomitantly.
Zyrtec er et antiallergisk lægemiddel. 
Zyrtec is an antiallergic medication.
Zyrtec kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, Zyrtec can cause side effects, although not everybody gets them.
Læs denne indlægsseddel grundigt, Den indeholder vigtige informationer. 
Read all of this leaflet carefully because it contains important information for you.
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. 
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.
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. 
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.
Selvom forekomsten af døsighed var statistisk mere almindelig end ved placebo, var den mild til moderat i størstedelen af tilfældene. 
Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases.
Derfor foreslår den harmoniserede formulering ikke en vægtbaseret dosering, da vægt tydeligvis ikke er den eneste faktor, som definerer dosis. 
This is why the harmonized wording does not propose a weight - based posology, as weight is clearly not the only factor to define the dose.
31-546 Krakow Polen 
31-546 Krakow Poland
Den systemiske eksponering ved halveret dosis er ikke dokumenteret, og utilstrækkelig effekt ved halve doser kan føre til, at patienter akkumulerer andre behandlinger. 
The systemic exposure with half doses is not documented and insufficient efficacy related to half doses may lead the patients to cumulate other treatments.
Sardenya 346 - 350 E - 08025 Barcelona Spanien 
Sardenya 346 - 350 E - 08025 Barcelona Spain
Afhængig af medlemsstaten er doseringen baseret på vægten eller alderen eller en kombination af begge dele, og der blev identificeret et antal aldersgrupper og doseringsgrupper. 
Depending on the member state, the posology is based on the weight or the age, or even a combination of both and a number of age groups and posology groups were identified.
NL-2909 LD Capelle a/d IJsel Holland 
NL-2909 LD Capelle a/d IJsel Nederland
08918 Badalona (Barcelona) Spanien 
08918 Badalona (Barcelona) Spain
D-76139 Karlsruhe TYSKLAND 
D-76139 Karlsruhe GERMANY
De virkninger, som er observeret i undersøgelser med dyr og ved doser, som er højere end de anbefalede og ikke i overensstemmelse med indikationen, skal slettes. 
The experimental effects observed in animals or at higher than recommended doses and not in line with the indication should be deleted.
Dyrestudier viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/fostrets udvikling, fødsel eller den postnatale udvikling. 
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Cetirizin modificerer ikke proteinbindingen af warfarin. 
Cetirizine does not modify the protein binding of warfarin.
Cetirizin 10 mg (n= 3260) 
Cetirizine 10 mg (n= 3260)
I 16 medlemsstater anbefales behandling med cetirizin også til spædbørn og små børn i alderen 1-2 år. 
In 16 member states, treatment with cetirizine is also recommended in infants and toddlers aged 1 to 2 years.
Opløsningen kan synkes, som den er. 
The solution can be swallowed as such.
De aktuelle pædiatriske indikationer mangler ikke harmonisering baseret på selve indikationen, men med hensyn til definitionen af de pædiatriske aldersgrupper og doseringen til disse grupper. 
The current paediatric indications are not disharmonised based on the indication itself but with regards to the definition of the paediatric age groups and with regards to the dosing for these groups.
UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Ungarn 
UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Hungary
Dette studie understøtter sikkerheden ved administrering af cetirizin til allergiske patienter med mild til moderat astma. 
This study supports the safety of administering cetirizine to allergic patients with mild to moderate asthma.
Decongestif & Antihistaminicu m 
Decongestif & Antihistaminicum
Luxembourg McNeil Roderveld 1 
Belgium McNeil Roderveld 1