natgillin/translations-raw huggingface dataset:
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med TESAVEL hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with TESAVEL in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Til patienter med svær nyreinsufficiens (GFR ≥15 til <30 ml/min) eller med nyresygdom i slutstadiet (ESRD) (GFR <15 ml/min), inklusive patienter som har behov for hæmodialyse eller peritonealdialyse, er dosis 25 mg TESAVEL en gang dagligt. 
For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of TESAVEL is 25 mg once daily.
TESAVEL er ikke undersøgt hos patienter med svær leverinsufficiens, og der bør udvises forsigtighed (se pkt. 
TESAVEL has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Hvis der er mistanke om en overfølsomhedsreaktion, skal Tesavel seponeres. 
If a hypersensitivity reaction is suspected, TESAVEL should be discontinued.
Sådan skal De tage TESAVEL 
How to take TESAVEL
Yderligere oplysninger om TESAVEL findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Til patienter med moderat nyreinsufficiens (GFR ≥30 til <45 ml/min) er dosis 50 mg TESAVEL en gang dagligt. 
For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of TESAVEL is 50 mg once daily.
som tripel oral behandling terapi sammen med 
as triple oral therapy in combination with
STOP med at tage TESAVEL og kontakt straks lægen, hvis De får nogen af følgende alvorlige bivirkninger: Svære og vedvarende smerter i maven, som kan stråle ud i ryggen, med eller uden kvalme og opkastning, da det kan være tegn på betændelse i bugspytkirtlen (pankreatitis). 
• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas
TESAVEL indeholder det aktive stof sitagliptin, som tilhører en klasse af lægemidler, som kaldes DPP-4-hæmmere (dipeptylpeptidase-4-hæmmere). 
TESAVEL contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Behandling med sitagliptin 100 mg en gang dagligt som monoterapi gav signifikante forbedringer i HbA1c, i faste-plasma-glucose, (FPG) og 2-timers postprandial glucose (2-timers PPG), når det blev sammenlignet med placebo i to undersøgelser, hvoraf den ene var af 18 ugers varighed og den anden af 24 ugers varighed. 
Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.
Efter 54 uger var den gennemsnitlige reduktion i forhold til baseline i HbA1c -0,76% med sitagliptin og -0,64% med glipizid (Per Protocol Analysis). 
After 54 weeks, the mean reduction from baseline in HbA1c was -0.76 % with sitagliptin and -0.64 % with glipizide (PerProtocol Analysis).
Hvis der er mistanke om bulløs pemfigoid, skal TESAVEL seponeres. 
If bullous pemphigoid is suspected, TESAVEL should be discontinued.
Hypoglykæmi i kombination med andre anti-hyperglykæmiske lægemidler Der er foretaget kliniske undersøgelser af TESAVEL som monoterapi og som del af kombinationsbehandling med lægemidler, der ikke er kendt for at medføre hypoglykæmi (dvs. metformin og/eller en PPAR-agonist). 
Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Nogle patienter har oplevet følgende bivirkninger, efter at sitagliptin er blevet føjet til metformin: Almindelige (kan berøre op til 1 ud af 10): lavt blodsukker, kvalme, øget luftafgang fra tarmen, opkastning. 
Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
MSD Α.Φ.Β.Ε.Ε Τηλ: + 30-210 98 97 300 dpoc_greece@merck.com 
Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com
TESAVEL er indiceret til at forbedre den glykæmiske kontrol: 
For adult patients with type 2 diabetes mellitus, TESAVEL is indicated to improve glycaemic control:
For at opnå den samme plasmakoncentration for sitagliptin som hos patienter med normal nyrefunktion bør patienter med GFR <45 ml/min samt ESRD-patienter med behov for hæmodialyse eller peritonealdialyse have lavere doser (se pkt. 
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
Det skal De vide, før De begynder at tage TESAVEL Sådan skal De tage TESAVEL Bivirkninger 
What TESAVEL is and what it is used for What you need to know before you take TESAVEL How to take TESAVEL
De kliniske data der er beskrevet nedenfor tyder på, at risikoen er lav for interaktioner af klinisk betydning mellem lægemidler, der administrres samtidigt. 
Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low.
Brug af anden medicin sammen med TESAVEL Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Peakplasmakoncentrationer (median Tmax) forkeom 1-4 timer efter dosering, gennemsnitlig plasma-AUC for sitagliptin var 8,52 µM•hr, Cmax var 950 nM. Sitagliptins absolutte biotilgængelighed er ca. 87%. 
Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 M•hr, Cmax was 950 nM.
TESAVEL 25 mg tabletter sitagliptin 
TESAVEL 25 mg tablets Sitagliptin
TESAVEL 100 mg tabletter sitagliptin 
TESAVEL 100 mg tablets Sitagliptin
TESAVEL 50 mg tabletter sitagliptin 
TESAVEL 50 mg tablets Sitagliptin
Reduktionen i HbA1c i forhold til de gennemsnitlige baseline værdier på 7,2% var -0,43% for sitagliptin og -0,57% for metformin (Per Protocol Analysis).Overordnet var incidensen for gastrointestinale bivirkninger, som blev anset for at være lægemiddelrelaterede, 2,7% hos patienter, der fik sitagliptin, sammenlignet med 12,6% hos de patienter, der fik metformin. 
The overall incidence of gastrointestinal adverse reactions considered as drug-related in patients treated with sitagliptin was 2.7 % compared with 12.6 % in patients treated with metformin.
EU/1/07/435/013 14 filmovertrukne tabletter EU/1/07/435/014 28 filmovertrukne tabletter EU/1/07/435/023 30 filmovertrukne tabletter EU/1/07/435/015 56 filmovertrukne tabletter EU/1/07/435/016 84 filmovertrukne tabletter EU/1/07/435/024 90 filmovertrukne tabletter EU/1/07/435/017 98 filmovertrukne tabletter EU/1/07/435/018 50 x 1 filmovertrukne tabletter 
EU/1/07/435/013 14 film-coated tablets EU/1/07/435/014 28 film-coated tablets EU/1/07/435/023 30 film-coated tablets EU/1/07/435/015 56 film-coated tablets EU/1/07/435/016 84 film-coated tablets EU/1/07/435/024 90 film-coated tablets EU/1/07/435/017 98 film-coated tablets EU/1/07/435/018 50 x 1 film-coated tablets
EU/1/07/435/001 14 filmovertrukne tabletter EU/1/07/435/002 28 filmovertrukne tabletter EU/1/07/435/019 30 filmovertrukne tabletter EU/1/07/435/003 56 filmovertrukne tabletter EU/1/07/435/004 84 filmovertrukne tabletter EU/1/07/435/020 90 filmovertrukne tabletter EU/1/07/435/005 98 filmovertrukne tabletter EU/1/07/435/006 50 x 1 filmovertrukne tabletter 
EU/1/07/435/001 14 film-coated tablets EU/1/07/435/002 28 film-coated tablets EU/1/07/435/019 30 film-coated tablets EU/1/07/435/003 56 film-coated tablets EU/1/07/435/004 84 film-coated tablets EU/1/07/435/020 90 film-coated tablets EU/1/07/435/005 98 film-coated tablets EU/1/07/435/006 50 x 1 film-coated tablets
EU/1/07/435/007 14 filmovertrukne tabletter EU/1/07/435/008 28 filmovertrukne tabletter EU/1/07/435/021 30 filmovertrukne tabletter EU/1/07/435/009 56 filmovertrukne tabletter EU/1/07/435/010 84 filmovertrukne tabletter EU/1/07/435/022 90 filmovertrukne tabletter EU/1/07/435/011 98 filmovertrukne tabletter EU/1/07/435/012 50 x 1 filmovertrukne tabletter 
EU/1/07/435/007 14 film-coated tablets EU/1/07/435/008 28 film-coated tablets EU/1/07/435/021 30 film-coated tablets EU/1/07/435/009 56 film-coated tablets EU/1/07/435/010 84 film-coated tablets EU/1/07/435/022 90 film-coated tablets EU/1/07/435/011 98 film-coated tablets EU/1/07/435/012 50 x 1 film-coated tablets
Patienterne fik sitagliptin (7.332) 100 mg dagligt (eller 50 mg dagligt, hvis eGFR ved baseline var ≥ 30 og < 50 ml/min/1,73 m2) eller placebo (7.339) som supplement til standardbehandling målrettet regionale standarder for HbA1c og kardiovaskulære risikofaktorer. 
The TECOS was a randomised in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0 % with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
- Lægen har ordineret TESAVEL til Dem personligt. 
- This medicine has been prescribed for you only.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ€ 
Driving and using machines
TESAVEL 100 mg filmovertrukne tabletter sitagliptin 
TESAVEL 100 mg film-coated tablets Sitagliptin
TESAVEL 25 mg filmovertrukne tabletter 
TESAVEL 25 mg film-coated tablets
TESAVEL 100 mg filmovertrukne tabletter 
TESAVEL 100 mg film-coated tablets
TESAVEL 25 mg filmovertrukne tabletter sitagliptin 
TESAVEL 25 mg film-coated tablets Sitagliptin
TESAVEL 50 mg filmovertrukne tabletter sitagliptin 
TESAVEL 50 mg film-coated tablets Sitagliptin
TESAVEL 50 mg filmovertrukne tabletter 
TESAVEL 50 mg film-coated tablets
Børn Der er ikke udført undersøgelser med anvendelse af TESAVEL til børn. 
Paediatric No studies with TESAVEL have been performed in paediatric patients.
Udseende og pakningsstørrelser 
What TESAVEL looks like and contents of the pack
Sitagliptin 100 mg en gang dagligt som supplement til igangværende behandling med pioglitazon + metforminbehandling 
Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
Lægemiddelform Administrati on 
Pharmaceutical form
1 hætteglas + 1 injektionssprøjte + 1 kanyle + 1 renseserviet 
1 vial + 1 injection syringe + 1 injection needle + 1 cleansing swab
12 hætteglas + 72 injektionssprøjter med påsat kanyle + 144 renseservietter 
12 vials + 72 injection syringes with attached needle + 144 cleansing swabs
2 hætteglas + 12 injektionssprøjter med påsat kanyle + 24 renseservietter 
2 vials + 12 injection syringes with attached needle + 24 cleansing swabs
1 hætteglas + 6 injektionssprøjter med påsat kanyle + 12 renseservietter 
1 vial + 6 injection syringes with attached needle + 12 cleansing swabs
Særnavn Styrke Lægemidde l¬form 
Strength Pharmaceutical Form
Tilbageho ldelsestid 
Withdrawal period
Indhold Pakningsstør relse 
Content Package size
Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase), inaktiverede, fra følgende stammer*: A/Brisbane/02/2018 (H1N1)pdm09- lignende stamme (A/Idaho/07/2018) 15 mikrogram HA** A/Kansas/14/2017 (H3N2)- lignende stamme (A/Indiana/08/2018) 15 mikrogram HA** B/Colorado/06/2017 - lignende stamme (B/Iowa/06/2017) 15 mikrogram HA** B/Phuket/3073/2013 - lignende stamme (B/Singapore/INFTT-16-0610/2016) 15 mikrogram HA** 
Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**
1 Hver 0,5 ml-dosis indeholder: 
--¹ 1 Each 0.5 ml dose contains:
* opformeret i Madin Darby Canine Kidney (MDCK)-celler. 
* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
pr. 0,5 ml-dosis 
per 0.5 ml dose
Fyldt injektionssprøjte (glas) uden kanyle 
Intramuscular use Pre-filled syringe (glass) without needle
De kan også have episoder med depression. 
They may also have episodes of depression.
Aripiprazole Zentiva aripiprazol 
Aripiprazole Zentiva aripiprazole
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aripiprazole Zentiva den 25. juni 2015. 
The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Zentiva on 25 June 2015.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Aripiprazole Zentiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR and risk management plan summary for Aripiprazole Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Der er udarbejdet en risikostyringsplan for at sikre, at Aripiprazole Zentiva anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible.
Udvalget anbefalede, at Aripiprazole Zentiva godkendes til anvendelse i EU. 
The Committee recommended that Aripiprazole Zentiva be approved for use in the EU.
Aripiprazole Zentiva fås som tabletter (5, 10, 15 og 30 mg) og som tabletter, der opløses i munden (smeltetabletter) (10, 15 and 30 mg). 
Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg).
Andre oplysninger om Aripiprazole Zentiva 
Other information about Aripiprazole Zentiva
Den virksomhed, der markedsfører Aripiprazole Zentiva, skal desuden udlevere oplysningsmateriale til patienterne eller deres omsorgsgivere og til lægerne, hvor det forklares, hvordan lægemidlet anvendes sikkert hos patienter mellem 13 og 17 år. 
In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
• bipolar lidelse type I, en psykisk sygdom, hvor patienterne skiftevis har episoder med abnormt højt humør (maniske episoder) og perioder med normalt humør. 
• bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Dosis bør tilpasses, hvis patienten får visse andre lægemidler, som påvirker nedbrydningen af Aripiprazole Zentiva i kroppen. 
The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Zentiva is broken down in the body.
Hvis du ønsker yderligere oplysninger om behandling med Aripiprazole Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Aripiprazole Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Aripiprazole Zentiva, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.
Aripiprazole Zentiva anvendes hos voksne til behandling af moderate til svære maniske episoder og forebyggelse af nye maniske episoder hos voksne, der tidligere har haft virkning af lægemidlet. 
Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Aripiprazole Zentiva i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Abilify. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be bioequivalent to Abilify.
Aripiprazole Zentiva anvendes hos patienter med følgende psykiske sygdomme: 
Aripiprazole Zentiva is used in patients with the following mental illnesses:
Da Aripiprazole Zentiva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet. 
Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
• skizofreni, der er en psykisk sygdom, som giver symptomer bl.a. i form tankeforstyrrelser og taleforstyrrelser, sansebedrag (hallucinationer), mistænksomhed og vrangforestillinger. 
• schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Det betyder, at Aripiprazole Zentiva svarer til et "referencelægemiddel", som allerede er godkendt i EU. 
This means that Aripiprazole Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Det aktive stof i Aripiprazole Zentiva, aripiprazol, er et antipsykotisk lægemiddel. 
The active substance in Aripiprazole Zentiva, aripiprazole, is an antipsychotic medicine.
Aripiprazole Zentiva anvendes til patienter over 15 år, 
Aripiprazole Zentiva is used in patients aged 15 years or over;
Patienter, der har vanskeligt ved at synke tabletter, kan få smeltetabletter. 
The orodispersible tablets can be used in patients who have difficulty swallowing tablets.
Til skizofreni er den anbefalede startdosis til voksne 10 eller 15 mg dagligt gennem munden, efterfulgt af en vedligeholdelsesdosis på 15 mg én gang dagligt. 
For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Aripiprazole Zentiva anvendes desuden hos patienter over 13 år til behandling af moderate til svære maniske episoder i op til 12 uger. 
Aripiprazole Zentiva is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Til behandling af maniske episoder ved bipolar sygdom er den anbefalede startdosis til voksne 15 mg gennem munden én gang dagligt. 
For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Aripiprazol bevirker derfor, at hjerneaktiviteten bliver normal, så de psykotiske eller maniske symptomer mindskes og ikke kommer igen. 
Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Til behandling af maniske episoder hos patienter mellem 13 og 17 år er startdosis 2 mg dagligt (hertil bruges aripiprazol-produkt i flydende form). 
For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Aripiprazole Zentiva er et "generisk lægemiddel". 
Aripiprazole Zentiva contains the active substance aripiprazole and is a ‘generic medicine'.
Patientundersøgelserne har derfor kun skullet vise, at det er bioækvivalent med referencelægemidlet, Abilify. 
Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Virksomheden ønskede, at markedsføringstilladelsen skulle anerkendes i Cypern, Den Tjekkiske Republik, Frankrig, Italien, Polen, Portugal, Spanien og Det Forenede Kongerige ("de berørte medlemsstater"). 
The company wanted the authorisation to be recognised in Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom (the ‘concerned Member States').
CHMP anbefalede ligeledes, at produktinformationen for lægemidlet blev ændret i alle de medlemsstater, hvor det har markedsføringstilladelse. 
The CHMP also recommended that the product information for the medicine should be amended in all the Member States where it is authorised.
Spørgsmål og svar vedrørende indbringelsesproceduren for Avalox infusionsvæske, opløsning, indeholdende moxifloxacin 400 mg/250 ml 
Questions and answers on the referral for Avalox solution for infusion containing moxifloxacin 400 mg/250 ml
Bayer Vital GmbH ansøgte om gensidig anerkendelse for Avalox infusionsvæske, opløsning, på baggrund af den første markedsføringstilladelse, der blev udstedt af Tyskland den 30. april 2002. 
Bayer Vital GmbH submitted Avalox solution for infusion for mutual recognition on the basis of the initial authorisation granted by Germany on 30 April 2002.
Begrundelserne for indbringelsen var Det Forenede Kongeriges betænkeligheder med hensyn til, at brugen af intravenøst moxifloxacin ved samfundserhvervet pneumoni og komplicerede hud- og bløddelsinfektioner skulle begrænses til de tilfælde, hvor standardbehandlingerne af disse infektioner ikke er velegnede, og Frankrigs betænkeligheder med hensyn til lægemidlets risiko for at medføre problemer med hjerterytmen (QT-intervalforlængelse). 
The grounds for the referral were concerns expressed by the United Kingdom that the use of intravenous moxifloxacin in community acquired pneumonia and complicated skin and soft tissues infections should be limited to when the standard treatments for these infections are not appropriate, and concerns from France regarding the medicine's risk of causing problems with the heart rhythm (QT-interval prolongation).
EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Avalox infusionsvæske, opløsning, opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Tyskland, kan anerkendes i andre EU-medlemsstater, nemlig Cypern, Den Tjekkiske Republik, Frankrig, Italien, Polen, Portugal, Spanien og Det Forenede Kongerige. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Avalox solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom.
Det aktive stof i Avalox infusionsvæske, opløsning, moxifloxacin, hører til gruppen af "fluorquinoloner". 
The active substance in Avalox solution for infusion, moxifloxacin, belongs to the group ‘fluoroquinolones'.