FrancophonIA/ELRC3.0 huggingface dataset:
English: In placebo controlled clinical trials of adult patients quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for major depressive episodes in bipolar disorder(see sections 4.8 and 5.1).
Danish: I placebo-kontrollerede kliniske studier med voksne patienter var quetiapin forbundet med en øget forekomst af ekstrapyramidale symptomer (EPS) sammenlignet med placebo hos patienter, som blev behandlet for depressive episoder inden for bipolar lidelse og unipolar depression (se pkt.
English: (7) An increase in the rate of dysphagia with quetiapine vs. placebo was only observed in the clinical trials in bipolar depression.
Danish: (7) Det var kun i de kliniske studier i bipolar depression, at der sås en øgning i forekomsten af dysfagi med quetiapin versus placebo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg quetiapine (as fumarate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 50 mg quetiapin (som fumarat)
English: Malta
Danish: BØRN
English: • Difficulty in passing urine.
Danish: • Vandladningsbesvær.
English: 6 blisters of 10 tablets
Danish: 6 blisterkort a 10 tabletter
English: (11) Cholesterol ≥240 mg/dL (≥6.2064 mmol/L) (patients ≥18 years of age) or ≥200 mg/dL (≥5.172 mmol/L) (patients <18 years of age) on at least one occasion.
Danish: (11) Mindst ét tilfælde af kolesterol ≥240 mg/dl (≥6,2064 mmol/l) (patienter ≥18 år) eller ≥200 mg/dl
English: • Rapid heartbeat.
Danish: • Hurtig hjerterytme (puls).
English: Leucopenia decreased neutrophil count, eosinophils increased27
Danish: Blod og lymfesystem22 Leukopeni 1, Nedsat , nedsat hæmoglobin neutrofiltal, forhøjede eosinofiler27
English: 2 blisters of 10 tablets
Danish: 2 blisterkort a 10 tabletter
English: Patients with preexisting severe cardiovascular disease may be at an increased risk of the effects of overdose.
Danish: Der kan være en øget risiko for overdosering hos patienter med kendt alvorlig kardiovaskulær sygdom (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg, 100 mg and 200 mg film-coated tablets quetiapine
Danish: Seroquel 25 mg, 100 mg og 200 mg filmovertrukne tabletter quetiapin
English: 100 prolonged-release tablets
Danish: 100 depottabletter
English: 9 blisters of 10 tablets
Danish: 9 blisterkort a 10 tabletter
English: • Sexual dysfunction.
Danish: • Synkebesvær.
English: Seroquel 150 mg film-coated tablets are pale yellow, round biconvex and engraved with SEROQUEL 150 on one side
Danish: Seroquel 150 mg filmovertrukne tabletter er lysegule, runde, bikonvekse og præget med SEROQUEL 150 på den ene side.
English: If you take more Seroquel XR than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heart beats.
Danish: Hvis du har taget for mange Seroquel Prolong depottabletter Hvis du tager flere Seroquel Prolong end lægen har anbefalet, kan du føle dig søvnig, svimmel og få en unormal hjerterytme (puls).
English: What Seroquel contains
Danish: Seroquel indeholder:
English: • If you get any side effects talk to your doctor or pharmacist.This includes any side effects not listed in this leaflet.
Danish: • Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,
English: INFORMATION IN BRAILLE Seroquel XR 150 mg
Danish: INFORMATION I BRAILLE-SKRIFT Seroquel Prolong 150 mg
English: How to store Seroquel XR
Danish: Stigning i serumtriglycer ider
English: 10 blisters of 10 tablets
Danish: 10 blisterkort a 10 tabletter
English: Seroquel XR 150 mg prolonged-release tablets quetiapine
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 150 mg depottabletter quetiapin
English: 3 blisters of 10 tablets
Danish: 3 blisterkort a 10 tabletter
English: INFORMATION IN BRAILLE Seroquel XR 200 mg
Danish: INFORMATION I BRAILLE-SKRIFT Seroquel Prolong 200 mg
English: Each tablet contains 200 mg quetiapine (as fumarate)
Danish: Seroquel 200 mg indeholder 200 mg quetiapin (som quetiapinfumarat).
English: Seroquel 100 mg contains 100 mg quetiapine (as quetiapine fumarate) Excipient : 20 mg lactose (anhydrous) per tablet
Danish: Seroquel 100 mg indeholder 100 mg quetiapin (som quetiapinfumarat).
English: Abnormal dreams and nightmares, Suicidal ideation and suicidal behaviour
Danish: Selvmordstan ker og selvmordsadf ærd
English: The dose may be adjusted depending on clinical response and tolerability of the individual patient, within the range of 200 to 800 mg/day.
Danish: Afhængigt af den enkelte patients kliniske respons og tolerabilitet kan dosis justeres i intervallet 200800 mg/dag.
English: INFORMATION IN BRAILLE Seroquel XR 400 mg
Danish: INFORMATION I BRAILLE-SKRIFT Seroquel Prolong 400 mg
English: • Increase in the amount of a hormone called prolactin, in the blood.
Danish: • Stigning i indholdet af hormonet prolaktin i blodet.
English: 30 prolonged-release tablets
Danish: 30 depottabletter
English: Seroquel XR 300 mg prolonged-release tablets quetiapine
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 300 mg depottabletter quetiapin
English: Dysphagia (See section 4.8) has been reported with quetiapine.
Danish: Der er rapporteret dysfagi med quetiapin (se pkt.
English: If you forget to take a dose of Seroquel XR
Danish: Hvis du har glemt at tage Seroquel Prolong
English: INFORMATION IN BRAILLE Seroquel XR 300 mg
Danish: INFORMATION I BRAILLE-SKRIFT Seroquel Prolong 300 mg
English: Seroquel SR
Danish: Seroquel SR: Portugal og Slovenien.
English: Seroquel 150 mg contains 150 mg quetiapine (as quetiapine fumarate) Excipient : 29 mg lactose (anhydrous) per tablet
Danish: Seroquel 150 mg indeholder 150 mg quetiapin (som quetiapinfumarat).
English: Each tablet contains 300 mg quetiapine (as fumarate)
Danish: Seroquel 300 mg indeholder 300 mg quetiapin (som quetiapinfumarat).
English: Seroquel XR 400 mg prolonged-release tablets quetiapine
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 400 mg depottabletter quetiapin
English: NAME OF THE MEDICINAL PRODUCT Seroquel XR 200 mg prolonged-release tablets quetiapine NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 200 mg depottabletter quetiapin NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AstraZeneca UDLØBSDATO
English: • Fits or seizures
Danish: Nyrer og urinveje
English: NAME OF THE MEDICINAL PRODUCT Seroquel XR 150 mg prolonged-release tablets quetiapine NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 150 mg depottabletter quetiapin NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AstraZeneca UDLØBSDATO
English: NAME OF THE MEDICINAL PRODUCT Seroquel XR 300 mg prolonged-release tablets quetiapine NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 300 mg depottabletter quetiapin NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AstraZeneca UDLØBSDATO
English: NAME OF THE MEDICINAL PRODUCT Seroquel XR 400 mg prolonged-release tablets quetiapine NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 400 mg depottabletter quetiapin NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AstraZeneca UDLØBSDATO
English: Seroquel XR 200 mg prolonged-release tablets quetiapine
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 200 mg depottabletter quetiapin
English: Seroquel XR should not be taken if you are breast-feeding.
Danish: Du må ikke tage Seroquel, mens du ammer.
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Danish: I nogle tilfælde blev der rapporteret om en forudgående vægtøgning, hvilket kan være en prædisponerende faktor.
English: o Men and women to have swelling of breasts and unexpectedly produce breast milk.
Danish: o Brysthævelse og uventet dannelse af brystmælk hos mænd og kvinder.
English: NAME OF THE MEDICINAL PRODUCT Seroquel XR 50 mg prolonged-release tablets quetiapine NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 50 mg depottabletter quetiapin NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AstraZeneca UDLØBSDATO
English: 50 prolonged-release tablets
Danish: 50 depottabletter
English: Quetiapine treatment has been associated with orthostatic hypotension and related dizziness (see Section 4.8) which, like somnolence has onset usually during the initial dose-titration period.
Danish: Behandlingen med quetiapin har været forbundet med ortostatisk hypotension ledsaget af svimmelhed (se pkt.
English: Coating
Danish: Seponering
English: Each tablet contains 400 mg quetiapine (as fumarate)
Danish: Seroquel Prolong 400 mg indeholder 400 mg quetiapin (som quetiapinfumarat).
English: Seroquel XR 50 mg prolonged-release tablets quetiapine
Danish: LÆGEMIDLETS NAVN Seroquel Prolong 50 mg depottabletter quetiapin
English: INFORMATION IN BRAILLE Seroquel XR 50 mg
Danish: INFORMATION I BRAILLE-SKRIFT Seroquel Prolong 50 mg
English: Each tablet contains 150 mg quetiapine (as fumarate)
Danish: Seroquel Prolong 150 mg indeholder 150 mg quetiapin (som quetiapinfumarat).
English: Use in children and adolescents Seroquel should not be used by children and adolescents aged under 18 years.
Danish: Brug til børn og unge Børn og unge under 18 år må ikke anvende Seroquel.
English: Very Common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer):
English: For add-on treatment of major depressive episodes in MDD:
Danish: o Til behandling af major depressive episoder inden for bipolar lidelse.
English: The available evidence from placebo-controlled clinical trials is presented in sections 4.4, 4.8, 5.1 and 5.2.
Danish: 4.4, 4.8, 5.1 og 5.2.
English: Your doctor will decide on your starting dose.
Danish: Din læge vil fortælle dig hvornår).
English: 60 prolonged-relaease tablets
Danish: 60 depottabletter
English: It can affect the way the medicine works.
Danish: medicinen virker.
English: This summary was last updated in 11-2014.
Danish: Dette sammendrag blev senest ajourført i 11-2014.
English: In addition, Trulicity has the advantage of being given once a week.
Danish: Desuden har Trulicity den fordel, at det kun skal gives én gang om ugen.
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere information fremgår af resuméet af risikostyringsplanen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trulicity on 21 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Trulicity den 21. november 2014.
English: Information from a sixth study that was submitted during the procedure was also considered.
Danish: Der blev desuden taget hensyn til oplysninger fra en sjette undersøgelse, som blev forelagt mens ansøgningen var under behandling.
English: Trulicity dulaglutide
Danish: Trulicity dulaglutid
English: This is a summary of the European public assessment report (EPAR) for Trulicity.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Trulicity.
English: The full EPAR and risk management plan summary for Trulicity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Trulicity findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Trulicity
Danish: Andre oplysninger om Trulicity
English: The benefits of Trulicity have been studied in 5 main studies involving over 4,500 patients with type 2 diabetes.
Danish: Fordelene ved Trulicity er undersøgt i 5 hovedundersøgelser med over 4 500 patienter med type 2sukkersyge.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Trulicity's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Trulicity overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: With respect to safety, effects of longer term use and safety in vulnerable groups such as the very elderly would need to be monitored, but there were no specific areas of major concern and the risks were considered similar to those of other medicines in its class.
Danish: Hvad sikkerheden angår, bør man overvåge de langsigtede virkninger og sikkerheden hos sårbare grupper såsom patienter med høj alder. Der var imidlertid ingen områder, der gav anledning til større betænkelighed, og risiciene blev anset for at være de samme som med andre lægemidler i denne klasse.
English: This was considered to be clinically meaningful and there was evidence that the benefits were maintained during long-term treatment.
Danish: Dette blev anset for at have klinisk betydning, og fordelene viste sig at vedvare ved langtidsbehandling.
English: A risk management plan has been developed to ensure that Trulicity is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Trulicity anvendes så sikkert som muligt.
English: The medicine was more effective at weekly doses of 1.5 mg than 0.75 mg.
Danish: Lægemidlet var mere effektivt i ugentlige doser på 1,5 mg end 0,75 mg.
English: The most common side effects with Trulicity (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting and diarrhoea.
Danish: De hyppigste bivirkninger ved Trulicity (som kan forekomme hos op til 1 ud af 10 personer) er kvalme, opkastning og diarré.
English: What measures are being taken to ensure the safe and effective use of Trulicity?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trulicity?
English: Trulicity contains the active substance dulaglutide.
Danish: Trulicity indeholder det aktive stof dulaglutid.
English: The active substance in Trulicity, dulaglutide, is a ‘GLP-1 receptor agonist'.
Danish: Det aktive stof i Trulicity, dulaglutid, er en “GLP-1-receptoragonist”.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Danish: HbA1c er et mål for, hvor velreguleret blodsukkeret er.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trulicity, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Trulicity, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: However, when used alone in patients who cannot take metformin, or when used in very elderly patients (aged over 75), the ratio of benefit to risk was greatest at the lower dose.
Danish: Når det blev anvendt alene hos patienter, der ikke tåler metformin, og når det blev anvendt hos patienter med høj alder (over 75 år), var forholdet mellem fordele og risici bedst ved den lavere dosis.
English: Why is Trulicity approved?
Danish: Hvorfor blev Trulicity godkendt?
English: Trulicity is available as prefilled pens (0.75 mg and 1.5 mg) containing a solution to be injected under the skin.
Danish: Trulicity leveres som fyldte penne (0,75 mg og 1,5 mg), der indeholder en opløsning, som indsprøjtes under huden.
English: What is Trulicity and what is it used for?
Danish: Hvad er Trulicity, og hvad anvendes det til?
English: Patients inject the medicine themselves (after suitable training) under the skin in the abdomen or thigh.
Danish: Patienterne giver sig selv lægemidlet (efter passende instruktion) under huden på maven eller i låret.
English: When Trulicity is injected, dulaglutide reaches the receptors in the pancreas and activates them.
Danish: Når Trulicity indsprøjtes, føres dulaglutid frem til receptorerne i bugspytkirtlen og aktiverer dem.
English: After 26 weeks of treatment, Trulicity reduced HbA1c by between 0.71 and 1.59 percentage points at the lower dose, and by between 0.78 and 1.64 percentage points at the higher dose.
Danish: Efter 26 ugers behandling mindskede Trulicity HbA1c med mellem 0,71 og 1,59 procentpoint i den lavere dosis, og med mellem 0,78 og 1,64 procentpoint i den højere dosis.
English: The patients' average HbA1c at baseline ranged from 7.6 to 8.5% and patients were treated for at least 52 weeks.
Danish: Patienternes gennemsnitlige HbA1c før behandlingen var mellem 7,6 og 8,5 %, og behandlingen varede i mindst 52 uger.
English: For the full list of all side effects and restrictions with Trulicity, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Trulicity fremgår af indlægssedlen.
English: The Committee noted that the medicine produces a significant and clinically relevant effect in controlling blood glucose when used with other medicines.
Danish: Udvalget bemærkede, at lægemidlet har en væsentlig blodsukkerregulerende virkning af klinisk betydning, når det bruges sammen med andre lægemidler.
English: What are the risks associated with Trulicity?
Danish: Hvilke risici er der forbundet med Trulicity?
English: It is not intended to provide practical advice on how to use Trulicity.
Danish: Det er ikke en praktisk vejledning i, hvordan Trulicity bør anvendes.
English: Trulicity was more effective than metformin at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines exenatide (given twice daily) or sitagliptin, and at least as good as insulin glargine, when used as add-on to other treatments.
Danish: Trulicity var mere effektivt end metformin til at nedsætte indholdet af HbA1c, når det blev anvendt alene, og var mere effektivt end sukkersygelægemidlerne exenatid (indgivet to gange dagligt) og sitagliptin, og mindst lige så godt som insulin glargin, når det blev anvendt som tillægsbehandling til andre behandlinger.
English: For more information about treatment with Trulicity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Trulicity, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Danish: Virkningen blev hovedsagelig bedømt på ændringen i indholdet af glykosyleret hæmoglobin (HbA1c), dvs. den procentdel af blodets hæmoglobin, der er bundet til sukker.
English: Trulicity can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine).
Danish: Trulicity kan anvendes som selvstændig behandling til patienter, hos hvem blodsukkeret ikke kan reguleres tilfredsstillende med diæt og motion alene, og som ikke må få metformin (et andet lægemiddel mod sukkersyge).
English: This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
Danish: Dette bevirker udskillelse af insulin og er medvirkende til at nedsætte blodsukkeret og regulere type 2-sukkersygen.
English: In these studies Trulicity was compared with placebo (a dummy treatment) or with other diabetes medicines when used alone or as an add-on to various combination treatments.
Danish: I undersøgelserne blev Trulicity sammenlignet med virkningsløs behandling (placebo) eller andre sukkersygelægemidler, enten alene eller som tillægsbehandling i forskellige kombinerede behandlinger.
English: It can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Danish: Trulicity kan desuden anvendes som tillægsbehandling til andre lægemidler mod sukkersyge, også insulin, når disse lægemidler sammen med motion og diæt ikke giver tilfredsstillende regulering af blodsukkeret.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Ved type 2-sukkersyge producerer bugspytkirtlen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet tilstrækkeligt.
English: For practical information about using Trulicity, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Trulicity, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: About 51% of those given the lower dose and 60% of patients given the higher dose of Trulicity achieved a target HbA1c below 7.0% and this was generally more than the proportion achieving this target with alternative treatments.
Danish: Ca. 51 % af dem, der fik den lavere dosis, og 60% af dem, der fik den højere dosis af Trulicity, nåede målværdien af HbA1c på under 7,0 %.
English: Trulicity is a diabetes medicine used in adults with type 2 diabetes to control their blood glucose (sugar) level.
Danish: Trulicity er lægemiddel mod sukkersyge, der bruges til regulering af blodsukkeret hos voksne med type 2-sukkersyge.
English: What benefits of Trulicity have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Trulicity?
English: How does Trulicity work?
Danish: Hvordan virker Trulicity?
English: The recommended dose is 0.75 mg injected once a week when used on its own, and 1.5 mg once a week in combination with other diabetes medicines (although doctors may begin with the lower dose in patients at potentially greater risk such as those aged over 75).
Danish: Den anbefalede dosis er 0,75 mg, der indsprøjtes én gang om ugen, når lægemidlet bruges alene, og 1,5 mg én gang om ugen, når det bruges i kombination med andre lægemidler mod sukkersyge.
English: How is Trulicity used?
Danish: Hvordan anvendes Trulicity?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom with a type of diabetes medicine called a sulphonylurea or with insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Danish: Når Trulicity anvendes i kombination med sukkersygelægemidler af typen sulfonylurinstof eller insulin, kan det være nødvendigt at sænke dosis af det pågældende sulfonylurinstof eller insulin for at undgå for lavt blodsukker (hypoglykæmi).
English: It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Danish: Det virker ved at bindes til receptorerne for glucagonlignende peptid 1 (GLP-1).
English: Oral suspension Oral use bottle (PET)
Danish: Oral anvendelse flaske (PET)
English: 0.5 mg/ml
Danish: 340 ml (0,5 mg/ml)
English: 340 ml (0.5 mg/ml) 1 bottle + 2 syringes + 1 bottle adapter
Danish: 1 flaske + 2 sprøjter + 1 adapter til flasken
English: Risk minimisation measures were proposed for the known risks.
Danish: Der blev foreslået risikominimeringsforanstaltninger for de kendte risici.
English: Outcome of re-examination of procedure under Article 29(4) of Directive 2001/83/EC
Danish: Resultatet af en revurdering i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF
English: The company requested a re-examination of the initial opinion.
Danish: Virksomheden har anmodet om en revurdering af den oprindelige udtalelse.
English: Why were Alcover granules reviewed?
Danish: Hvorfor blev Alcover vurderet igen?
English: Alcover syrup is available in Austria and Italy.
Danish: Alcover-syrup fås i Østrig og Italien.