FrancophonIA/ELRC3.0 huggingface dataset:
English: Having considered available guidelines and relevant literature and considering the magnesium content of Numeta, the PRAC concluded that the administration of Numeta G13%E could lead to a higher risk of hypermagnesaemia.
Danish: Efter gennemgang af de foreliggende retningslinjer og relevant litteratur og under hensyntagen til magnesiumindholdet i Numeta konkluderede PRAC, at indgivelse af Numeta G13%E kunne medføre øget risiko for hypermagnesiæmi.
English: In addition, the PRAC recommended a study be carried out to further evaluate blood magnesium levels observed in term newborn infants and children up to two years of age following use of Numeta G16%E.
Danish: Desuden anbefalede PRAC, at der udføres yderligere undersøgelse til vurdering af de iagttagne magnesiumværdier i blodet hos nyfødte og børn op til to år efter behandling med Numeta G16%E.
English: The maximum total licensed amount of magnesium that can be delivered to preterm infants using Numeta G13%E is 0.55 mmol/kg/day which is above this recommended intake.
Danish: Den maksimale samlede godkendte mængde magnesium, der kan gives til præmature spædbørn med Numeta G13%E, er 0,55 mmol/kg/dag, hvilket er over det anbefalede indtag.
English: The review of Numeta G13%E and Numeta G16%E was carried out by the the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) following several reports of hypermagnesaemia (without clinical symptoms) in preterm infants.
Danish: Gennemgangen af Numeta G13%E og Numeta G16%E blev foretaget af Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC) efter en række indberetninger om hypermagnesiæmi (uden kliniske symptomer) hos for tidligt fødte børn.
English: • The company identified one case of hypermagnesaemia associated with Numeta G16%E.
Danish: • Virksomheden identificerede ét tilfælde af hypermagnesiæmi i forbindelse med Numeta G16%E.
English: For Numeta G16%E, the PRAC concluded that although the magnesium content may result in a magnesium intake that is slightly higher than suggested in some guidelines, the proposed measures, including updating the product information and a further study, are sufficient to ensure the safe use of this product.
Danish: For Numeta G16%E konkluderede PRAC, at skønt magnesiumindholdet i produktet kan medføre en smule højere magnesiumindtag end det anbefales i visse retningslinjer, er de foreslåede foranstaltninger - bestående i opdatering af produktinformationen og en yderligere undersøgelsetilstrækkelige til at sikre risikofri anvendelse af produktet.
English: The product information should be revised accordingly and healthcare professionals should be informed in writing of the potential risk of hypermagnesaemia, which is increased in patients with impaired kidney function and those whose mothers were receiving supplemental magnesium before delivery, and of the measures to be taken to minimise this risk.
Danish: Produktinformationen bør revideres i henhold hertil, og sundhedspersoner bør informeres skriftligt, dels om den øgede risiko for hypermagnesiæmi hos børn med nedsat nyrefunktion og børn af mødre, der fik magnesiumtilskud før fødslen, dels om de nødvendige foranstaltninger til minimering af denne risiko.
English: Parenteral nutrition is the providing of nutrients and fluids through a vein in patients who cannot be fed by mouth or by enteral nutrition (the use of a feeding tube passed directly into the gut).
Danish: Parenteral ernæring er tilførsel af næringsstoffer og væsker gennem en blodåre hos patienter, der ikke kan indtage næring gennem munden eller ved sondeernæring (med en sonde, der er ført direkte ind i tarmen).
English: Numeta G13%E, which is given into a vein to premature babies to provide nutritional support (intravenous nutrition or parenteral nutrition), will remain suspended until a re-formulated preparation is made available.
Danish: Numeta G13%E, der indgives i en vene på for tidligt fødte børn som ernæringsstøtte (intravenøs eller parenteral ernæring), skal forblive suspenderet, indtil et omformuleret præparat foreligger.
English: The PRAC assessed the available data on the risk of hypermagnesaemia with Numeta G13%E and Numeta G16%E preparations from clinical studies, post-marketing reports and the published literature and considered available treatment guidelines.
Danish: PRAC vurderede de foreliggende data om risikoen for hypermagnesiæmi med præparaterne Numeta G13%E og Numeta G16%E fra kliniske undersøgelser, indberetninger efter markedsføring og den videnskabelige litteratur, og tog de eksisterende retningslinjer på området i betragtning.
English: • The company marketing Numeta identified 14 case reports of hypermagnesaemia with Numeta G13%E.
Danish: • Den virksomhed, der markedsfører Numeta, identificerede 14 indberettede tilfælde om hypermagnesiæmi med Numeta G13%E.
English: • Doctors should also monitor patients for signs and symptoms of hypermagnesaemia such as nausea, vomiting and flushing, generalized weakness, respiratory failure, hypotension and arrhythmias.
Danish: • Lægen skal desuden overvåge patienterne for tegn og symptomer på hypomagnesiæmi såsom kvalme, opkastning og rødme, almen svaghed, respirationssvigt, hypotension og arytmier.
English: In patients whose blood magnesium levels are elevated or signs of hypermagnesaemia are identified Numeta G16%E should be stopped or the infusion rate reduced.
Danish: Hos patienter med forhøjet magnesiumindhold i blodet eller tegn på hypermagnesiæmi skal behandlingen med Numeta G16%E ophøre eller infusionshastigheden nedsættes.
English: For another nutrition preparation given into a vein, Numeta G16%E, used in full-term newborns and children up to 2 years, the CMDh agreed that the benefit-risk balance remains positive, provided that healthcare professionals monitor their patients' blood magnesium levels before giving the preparation and at appropriate intervals thereafter in accordance with routine clinical practice and the clinical needs of the individual patient.
Danish: For et andet ernæringspræparat, Numeta G16%E, der indgives i en vene på fuldbårne nyfødte og børn op til to år, vedtog CMDh, at forholdet mellem fordele og risici stadig er positivt, dog under forudsætning af, at sundhedspersoner overvåger magnesiumindholdet i patientens blod både før præparatets indgivelse og efterfølgende i henhold til sædvanlig klinisk praksis og den enkelte patients kliniske behov.
English: • In case of hypermagnesaemia, the infusion of Numeta G16%E should be stopped or infusion rate reduced and alternative fluids, nutrition and electrolytes prescribed as deemed clinically appropriate.
Danish: • Ved hypermagnesiæmi bør infusionen af Numeta G16%E standses eller infusionshyppigheden nedsættes, og der bør ordineres andre væsker, næringsstoffer og elektrolytter, alt efter hvad der anses for klinisk hensigtsmæssigt,
English: Numeta G13%E and Numeta G16%E (glucose, lipids, aminoacids and electrolytes) are parenteral nutrition solutions.
Danish: Numeta G13%E og Numeta G16%E er l parenterale ernæringsopløsninger (sukker, fedtstoffer, aminosyrer og elektrolytter).
English: • The nutrition preparation Numeta G16%E can continue to be used in full-term newborns and children up to 2 years, however the doctor will monitor the levels of magnesium in the child's blood before giving the preparation and at appropriate intervals thereafter.
Danish: • Ernæringspræparatet Numeta G16%E kan fortsat anvendes hos fuldbårne nyfødte og børn op til to år, men lægen skal overvåge magnesiumindholdet i barnets blod, før præparatet gives og efterfølgende med passende mellemrum.
English: • When giving Numeta G16%E, doctors should monitor serum magnesium levels, along with other electrolyte levels at baseline and at appropriate intervals thereafter.
Danish: • Ved administration af Numeta G16%E bør lægen overvåge blodets indhold af serum-magnesium forruden andre elektrolytter ved baseline og efterfølgende med passende intervaller.
English: Hypermagnesaemia is a serious condition and symptoms may include weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Danish: Hypermagnesiæmi er en alvorlig tilstand, der kan give symptomer i form af svaghed, kvalme og opkastning, åndedrætsbesvær, for lavt blodtryk (hypotension) og uregelmæssig hjerterytme (arytmier).
English: Numeta preparations are given to provide nutritional support in children who cannot be fed by mouth or with a feeding tube.
Danish: Numeta-præparater gives som er ernæringsstøtte til børn, der ikke kan indtage næring gennem munden eller med sonde.
English: • Following several reports of hypermagnesaemia in preterm infants, the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
Danish: • Efter flere indberetninger om hypermagnesiæmi hos præmature spædbørn er ernæringspræparatet Numeta G13%E blevet suspenderet, indtil et omformuleret præparat er til rådighed.
English: • The maximum total amount of magnesium that can be delivered to term infants using Numeta G16%E according to its product information is 0.3 mmol/kg/day.
Danish: • I henhold til produktinformation er den maksimale mængde magnesium med Numeta G16%E, der kan gives til fuldbårne børn 0,3 mmol/kg/dag.
English: • The benefit-risk balance of the nutrition preparation Numeta G16%E, used in full-term newborns and children up to 2 years, remains positive.
Danish: • Benefit/risk-forholdet er fortsat positivt for ernæringspræparatet G16%E ved anvendelse hos fuldbårne nyfødte og børn op til to år.
English: Numeta G13%E is given into a vein to provide nutritional support in premature babies who cannot be fed by mouth or with a feeding tube.
Danish: Numeta G13%E indgives i en vene for at tilføre næringsstoffer til for tidligt fødte spædbørn, der ikke kan indtage føde gennem munden eller gennem sonde.
English: Doctors will monitor newborns and children who are receiving Numeta G16%E for symptoms of hypermagnesaemia such as weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Danish: Lægen bør overvåge nyfødte og børn, der får Numeta G16%E, for symptomer på svaghed, kvalme og opkastning, åndedrætsbesvær, for lavt blodtryk (hypotension) og uregelmæssig hjerterytme (arytmier).
English: • Because of the risk of hypermagnesaemia (high blood levels of magnesium), the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
Danish: • På grund af risikoen for forhøjet magnesiumindhold i blodet (hypermagnesiæmi) er ernæringspræparatet Numeta G13%E blevet trukket tilbage fra markedet, indtil et præparat med en anden sammensætning er til rådighed.
English: The doctor will stop giving Numeta G16%E if magnesium levels are high, or will give Numeta at a slower rate.
Danish: Hvis magnesiumindholdet er højt, skal lægen ophøre med at give Numeta G16%E eller give Numeta mindre hyppigt.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a medicines regulatory body representing the European Union (EU) Member States, has endorsed by consensus the recommendation to suspend the marketing authorisation of Numeta G13%E because of a risk of hypermagnesaemia (high blood levels of magnesium).
Danish: På grund af risikoen for forhøjet magnesiumindhold i blodet (hypermagnesiæmi) skal markedsføringstilladelsen for Numeta G13%E suspenderes ifølge en anbefaling, der enstemmigt er vedtaget i Koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMDh) (en lægemiddelmyndighed, der repræsenterer EU's medlemsstater).
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicant in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrke, indgivelsesvej, ansøgere i medlemsstaterne
English: Slovak Republic
Danish: Slovak Republik
English: Via E. Folli 50 20134 Milano Italy
Danish: Via E. Folli 50 20134 Milano Italien
English: 2700 AN, Zoetermeer The Netherlands
Danish: 2700 AN, Zoetermeer Holland
English: Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italy
Danish: Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italien
English: Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italy
Danish: Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italien
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Netherlands AstraZeneca BV Postbus 599
Danish: Holland AstraZeneca BV Postbus 599
English: Norway AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO
Danish: AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO
English: AstraZeneca UK Ltd., Silk Road Business Park ,SK10 2NA Macclesfield, Cheshire, United Kingdom
Danish: AstraZeneca UK Ltd., Silk Road Business Park, SK10 2NA Macclesfield, Cheshire, Storbritannien
English: Hungary AstraZeneca Kft. H-2045 Törökbálint, Park u. 3.
Danish: AstraZeneca Kft. H-2045 Törökbálint, Park u.
English: Germany AstraZeneca GmbH 22876 Wedel
Danish: Tyskland AstraZeneca GmbH 22876 Wedel
English: AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom
Danish: AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU Storbritannien
English: 2620 Albertslund Denmark
Danish: 2620 Albertslund Danmark
English: DK-2620 Albertslund Denmark
Danish: DK-2620 Albertslund Danmark
English: 1, Place Renault 92844 RUEIL-MALMAISON Cedex
Danish: Frankrig AstraZeneca 1, Place Renault 92844 RUEILMALMAISON Cedex Frankrig
English: AstraZeneca AB, 151 85 Södertälje Sweden
Danish: AstraZeneca AB, 151 85 Södertälje, Sverige
English: Sweden AstraZeneca AB S-151 85 Södertälje Sweden
Danish: Rumænien AstraZeneca AB, S-151 85 Södertälje Sverige
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien
Danish: Schwarzenbergplatz 7, A-1037 Wien Østrig
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels
Danish: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Bruxelles
English: Laboratorio Tau, S.A. C/ Serrano Galvache, 56 Edificio Roble 28033 Madrid Spain
Danish: Spanien Laboratorio Tau, S.A. C/ Serrano Galvache, 56
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussel
Danish: NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Bruxelles Belgien
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece
Danish: 151 25 Maroussi Athen Grækenland
English: MUPS
Danish: Lösungsmittel
English: Losec 10 mg kapszula 10 mg Capsule, hard
Danish: Losec 10 mg kapszula
English: Losec 40 mgTrockenstechampulle mit Lösungsmittel
Danish: Losec 40 mgTrockenstechamp ulle mit
English: 40 mg/ml Powder and Solvens for solution for injection
Danish: 40 mg/ml Pulver og solvens til injektionsvæske, opløsing
English: Denmark
Danish: Sverige
English: Losec Capsules 10mg 10mg Hard gelatin capsules
Danish: Losec Capsules 10mg
English: 20mg
Danish: Antra MUPS 20 mg
English: LOSEC cápsulas 20 mg 20 mg Capsules, hard
Danish: LOSEC 20 mg 20 mg Enterokapsler, hårde
English: LOSEC 20 mg
Danish: LOSEC cápsulas 20 mg
English: 40 mg Powder for infusion
Danish: 40 mg Pulver til infusionssvæske, opløsing
English: LOSEC 40 mg
Danish: Losec Infusion 40mg
English: Losec Capsules 20mg 20mg Hard gelatin capsules
Danish: Losec Capsules 20mg
English: Losec 20 mg kapszulaz 20 mg Capsule, hard
Danish: Losec 20 mg kapszulaz
English: Antra MUPS 10 mg 10 mg Gastro-resistant tablets
Danish: Antra MUPS 10 mg
English: Losec MUPS 10
Danish: Losec 10mgKapseln
English: 10 mg Gastro-resistant capsules, hard Oral use
Danish: 10 mg Kapsler med modificeret udløsning, hårde
English: Losec 40 MG
Danish: Losec Capsules 40mg
English: Antra MUPS 40 mg 40 mg Gastro-resistant tablets
Danish: Antra MUPS 40 mg
English: Logastric-Mups 40mg, 40 mg, maagsapresistente tabletten
Danish: Logastric-Mups 40mg, 40 mg, maagsapresistente capsules
English: Losec MUPS Γαστροανθεκτικό δισκίο 10 mg/TAB
Danish: Losec MUPS Γαστροανθεκτικό δισκίο
English: 20 mg Gastro-resistant capsules, hard Oral use
Danish: 20 mg Kapsler med modificeret udløsning, hårde
English: Losec MUPS 20
Danish: Losec 20mgKapseln
English: 40 mg Gastro-resistant capsules, hard Oral use
Danish: 40 mg Kapsler med modificeret udløsning, hårde
English: 40 mg Powder and solvent for solution for injection
Danish: 40 mg Pulver og solvens til injektionsvæske, opløsing
English: 40 mg Powder and solvent for injectable solution
Danish: 40 mg Pulver og solvens til injektionsvæske, opløsning
English: It usually appears between 40 and 50 years of age.
Danish: Den viser sig normalt mellem 40 og 50 års alderen.
English: The absolute risk reduction was 4.2%.
Danish: Den absolutte risikoreduktion var 4,2%.
English: Hazard ratio [95% CI]
Danish: Hazard ratio [95% KI]
English: United Kingdom EX31 3UD
Danish: Storbritannien EX31 3UD
English: Elevated creatinine in blood
Danish: Forhøjet kreatinin i blodet
English: Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes.
Danish: Færre end 1% af patienterne måtte ændre deres daglige rutine eller stoppe behandlingen på grund af fosfener.
English: All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment.
Danish: Alle fosfener forsvandt under eller efter behandlingen, de fleste (77,5%) under behandlingen.
English: The absolute bioavailability of the film-coated tablets is around 40%, due to first-pass effect in the gut and liver.
Danish: Den absolutte biotilgængelighed af de filmovertrukne tabletter er ca. 40% på grund af en førstepassage-effekt i tarm og lever.
English: Applicable only for the outer packaging component: PC:
Danish: Gælder kun den ydre emballage: PC:
English: 2900 Komárom Hungary
Danish: 2900 Komárom Ungarn
English: Bradycardia was reported by 3.3% of patients particularly within the first 2 to 3 months of treatment initiation.
Danish: Bradykardi rapporteredes af 3,3% af patienterne, specielt inden for de første to til tre måneders behandling.
English: Food delayed absorption by approximately 1 hour, and increased plasma exposure by 20 to 30%.
Danish: Føde forsinkede absorptionen med ca. 1 time og øgede plasmaeksponering med 20-30%.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Jenson R+ Limited
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Jenson R+ Limited
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: Trykte indlægsseddel for lægemidlet skal der anføres navn og adresse på fremstilleren ansvarlig for frigivelsen af den pågældende batch.
English: Children and adolescents Ivabradine JensonR is not intended for use in children and adolescents younger than 18 years.
Danish: Børn og unge Ivabradine JensonR er ikke beregnet til børn og unge under 18 år.
English: N-desmethylated derivative of ivabradine has been identified as the main active metabolite in humans.
Danish: Det N-demethylerede derivat af ivabradin er identificeret som den aktive hovedmetabolit hos mennesker.
English: Special populations - Elderly: no pharmacokinetic differences (AUC and Cmax) have been observed between elderly (≥65 years) or very elderly patients (≥75 years) and the overall population (see section 4.2).
Danish: Særlige populationer - Ældre: Der er ikke observeret farmakokinetiske forskelle (AUC og Cmax) mellem ældre (≥ 65 år) eller gamle patienter (≥ 75 år) og den samlede population (se pkt.
English: Under physiological conditions, ivabradine is rapidly released from tablets and is highly water-soluble (>10 mg/ml).
Danish: Under fysiologiske betingelser frigøres ivabradin hurtigt fra tabletterne og er letopløseligt i vand (> 10 mg/ml).
English: Linearity/non-linearity The kinetics of ivabradine is linear over an oral dose range of 0.5-24 mg.
Danish: Linearitet/non-linearitet Ivabradins kinetik er lineær over en oral dosisspændvidde på 0,5 - 24 mg.
English: If you forget to take a dose of Ivabradine JensonR, take the next dose at the usual time.
Danish: Hvis De glemmer at tage en dosis Ivabradine JensonR, skal De tage den næste dosis til normal tid.
English: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: I de kliniske studier er der rapporteret om følgende bivirkninger, som er opstillet efter hyppighed i henhold til denne konvention: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Yellow iron oxide (E172) Red iron oxide (E172) Polysorbate 80
Danish: Gul jernoxid (E172) Rød jernoxid (E172) Polysorbat 80
English: In the ivabradine group, 67% of patients were treated with 7.5 mg twice a day.
Danish: I ivabradingruppen blev 67% af patienterne behandlet med 7,5 mg to gange dagligt.
English: GSP Proizvodi d.o.o.
Danish: GSP Proizbosi d.o.o.
English: Luminous phenomena (phosphenes)
Danish: Lysfænomen (fosfener, fotopsier)
English: The long-term effects of ivabradine on growth, puberty and general development as well as the long-term efficacy of therapy with ivabradine in childhood to reduce cardiovascular morbidity and mortality have not been studied.
Danish: Ivabradins langtidsvirkninger på vækst, pubertet og den generelle udvikling såvel som landtidsvirkningen af behandling med ivabradin til reduktion af kardiovaskulær morbiditet og mortalitet i barndommen er ikke blevet undersøgt.
English: EU/1/16/1145/016 EU/1/16/1145/017
Danish: EU/1/16/1145/017
English: If any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine JensonR.
Danish: Hvis noget af ovenstående gælder for Dem, skal De straks tale med Deres læge om det, før eller mens De tager Ivabradine JensonR.
English: Ivabradine is approximately 70% plasma protein bound and the volume of distribution at steady-state is close to 100 l in patients.
Danish: Ivabradin er ca. 70% bundet til plasmaproteiner, og fordelingsvolumenet i steady-state er næsten 100 l hos patienter.
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine JensonR.
Danish: Kalenderen på blisteren, som indeholder tabletterne, skal hjælpe Dem med at huske, hvornår De sidst tog en Ivabradine JensonR-tablet.
English: See package leaflet for further information.
Danish: Læs indlægssedlen for yderligere oplysninger.
English: Jenson R+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, United Kingdom EX31 3UD
Danish: Jenson R+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, Storbritannien EX31 3UD
English: Ivabradine is eliminated with a main half-life of 2 hours (70-75% of the AUC) in plasma and an effective half-life of 11 hours.
Danish: Ivabradin udskilles med en hovedhalveringstid på 2 timer (70-75% af AUC) i plasma og en effektiv eliminationshalveringstid på 11 timer.
English: Very rare (may affect up to 1 in 10,000 people): Irregular heart beats.
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): Uregelmæssig puls.
English: CARTON/BOTTLE LABEL
Danish: KARTON/FLASKEETIKET
English: Film-coating Hypromellose Titanium dioxide Macrogol 400
Danish: Titandioxid Macrogol 400
English: The European Medicines Agency has waived the obligation to submit the results of studies with ivabradine in children aged 0 to less than 6 months in the treatment of chronic heart failure.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Ivabradine JensonR til børn i alderen 0 til under 6 måneder til behandling af kronisk hjerteinsufficiens.