FrancophonIA/ELRC3.0 huggingface dataset:
English: HOW TO TAKE {PRODUCT NAME}
Danish: SÅDAN SKAL DE TAGE ZARATOR
English: − Renal impairment
Danish: • uskarpt syn
English: − Keep this leaflet.
Danish: Se pkt.
English: Excipients
Danish: Aterosklerose
English: BEFORE YOU TAKE {PRODUCT NAME}
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ZARATOR
English: • hearing loss
Danish: • høretab
English: What {PRODUCT NAME} looks like and contents of the pack [To be completed nationally]
Danish: Udseende og pakningstørrelser Udseende [Udfyldes nationalt]
English: Content
Danish: Navn
English: (Invented) name Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: EMEA Number
Danish: EMEA's procedurenr.
English: 1 pre-filled syringe with automatic needle guard (blistered)
Danish: 1 fyldt injektionssprøjte med automatisk kanylehætte (blister)
English: 1 pre-filled syringe (blistered)
Danish: 1 fyldt injektionssprøjte (blister)
English: 1 pre-filled syringe (non-blistered)
Danish: 1 fyldt injektionssprøjte (uden blister)
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Danish: Liste over navne, lægemiddelform, lægemidlets styrke, administrationsvej, ansøger i medlemsstaterne
English: United Kingdom Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel
Danish: Grækenland Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel
English: Duration of treatment:
Danish: Varighed af behandlingen:
English: Usually, the maximum treatment duration should not exceed one week.
Danish: Normalt bør den maksimale behandligsvarighed ikke overstige en uge.
English: If you forget to take X
Danish: Hvis du har glemt at tage X
English: If convenient, a glass of water can be taken afterwards.
Danish: Hvis det er hensigtsmæssigt, kan et glas vand tages bagefter.
English: The above list of substances is representative and not exhaustive.
Danish: Ovenstående liste over lægemidler er repræsentativ, men ikke udtømmende.
English: [For oral formulations]: It is recommended to take oral <X> before meals.
Danish: [For orale formuleringer]: Det anbefales at tage oral <X> før måltider.
English: Do not take {Tradename} for longer than 7 days without consulting your doctor.
Danish: Du må ikke tage {Handelsnavn} i mere end 7 dage uden at rådføre dig med din læge.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Denne produktinformation kan om nødvendig efterfølgende opdateres af de relevante myndigheder i medlemslandene i samarbejde med reference-medlemslandet i henhold til procedurerne i kapitel 4 af Title III af Direktiv 2001/83/EC.
English: Take your medicine as soon as you remember.
Danish: Tag din medicin, så snart du kommer i tanker om det.
English: Do not give more than 3 times in a 24 hour time period.
Danish: Giv ikke mere end 3 gange indenfor en 24 timers periode.
English: Patients should try to take each dose at the scheduled time.
Danish: Patienten skal forsøge at tage hver dosis på det planlagte tidspunkt.
English: The dose may also need to be reduced.
Danish: Det kan desuden være nødvendigt at reducere dosis.
English: In accordance with ICH-E14 guidelines, a thorough QT study was performed.
Danish: I overensstemmelse med ICH-E14-guidelines blev et uddybende QT-studie udført.
English: Treatment with domperidone should be stopped.
Danish: Behandling med domperidon bør stoppes.
English: If {Product name} is for a child, ask your doctor for the children's formulation.
Danish: Hvis {Produktnavn} er til et barn, så spørg din læge efter en formulering til børn.
English: Symptoms usually resolve with 3-4 days of taking this medicine.
Danish: Symptomerne forsvinder som regel efter 3-4 dage, når du tager dette lægemiddel.
English: Ask your doctor for advice before taking this medicine.
Danish: Spørg din læge, før du tager dette lægemiddel.
English: No teratogenicity was observed in mice and rabbits
Danish: Der sås ingen teratogenicitet hos mus og kaniner.
English: The risk also increases when domperidone is given together with some drugs.
Danish: Risikoen øges også, når domperidon gives samtidig med visse lægemidler.
English: The relevance of the latter study for humans following exposure to orally administered domperidone is uncertain.
Danish: Relevansen af sidstnævnte studie for mennesker efter eksponering for oralt indgivet domperidon er usikker.
English: Do not take {Product Name} if you are taking medicine to treat:
Danish: Tag ikke {Produktnavn}, hvis du tager medicin til behandling af:
English: Section 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: When taken without water, the tablet should be placed on the tongue and dissolve in the mouth before swallowing.
Danish: Når den tages uden vand, skal tabletten placeres på tungen og opløses i munden, før den synkes.
English: Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk.
Danish: Forekomst af bivirkninger, især hjertepåvirkninger, kan ikke udelukkes efter eksponering via modermælk.
English: If it is almost time for your next dose, wait until that is due and then continue as normal.
Danish: Hvis det næsten er tidspunktet for din næste dosis, skal du vente til den næste dosis og derefter fortsætte som normalt.
English: Section 4.6 Fertility, pregnancy and lactation
Danish: 4.6 Fertilitet, graviditet og amning
English: The unbound fraction is increased by 25 %, and the terminal elimination half-life is prolonged from 15 to 23 hours.
Danish: Den ubundne fraktion er øget med 25 %, og den terminale elimineringshalveringstid er forlænget fra 15 til 23 timer.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Ændringer til relevante afsnit i produktresume og indlægsseddel
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af benfit/risk-forholdet for lægemidlet.
English: Tablets, Effervescent granules, Suppositories
Danish: Tabletter, brusegranulater, suppositorier
English: Domperidone should be used at the lowest effective dose in adults and children.
Danish: Domperidon bør anvendes i den laveste effektive dosis til voksne og børn.
English: Oral domperidone should be taken before meals/feeding.
Danish: Oral domperidon bør tages før måltider/madning.
English: Small amounts of domperidone have been detected in breast milk.
Danish: Der er fundet små mængder domperidon i mælk.
English: During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone.
Danish: Under overvågning efter markedsføring har der været meget sjældne tilfælde af QT-forlængelse og torsades de pointes hos patienter, der fik domperidon.
English: pentamidine (these are antibiotics)
Danish: pentamidin (antibiotika)
English: • malaria (in particular halofantrine)
Danish: • malaria (især halofantrin)
English: The orodispersible tablet dissolves rapidly in the mouth with the help of the saliva, and the can be taken with or without water.
Danish: Smeltetabletten opløses hurtigt i munden ved hjælp af spyt, og den kan tages med eller uden vand.
English: dofetilide, sotalol, diltiazem, verapamil)
Danish: dofetilid, sotalol, diltiazem, verapamil)
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Danish: Hvis du oplever bivirkninger, bør du tale med din <læge> <eller> <,> <apokeket> <eller sygeplejersken>.
English: If you have used or taken too much {Tradename}, contact your doctor, pharmacist or the poison centre immediately, in particular if a child has taken too much.
Danish: Hvis du har taget for meget {Handelsnavn}, så kontakt straks lægen, apoteket eller skadestuen, navnlig hvis et barn har taget for meget.
English: Domperidone is excreted in human milk and breast-fed infants receive less than 0.1 % of the maternal weight-adjusted dose.
Danish: Domperidon udskilles i human mælk, og spædbørn, der ammes, får mindre end 0,1% af moderens vægtjusterede dosis.
English: ▼This medicine is subject to additional monitoring.
Danish: ▼ Dette lægemiddel er underlagt supplerende overvågning.
English: • AIDS/HIV (protease inhibitors)
Danish: • AIDS/HIV (proteasehæmmere)
English: If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed.
Danish: Hvis en planlagt dosis glemmes, bør den glemte dosis udelades, og den sædvanlige dosering genoptages.
English: At a high maternally toxic dose (more than 40 times the recommended human dose), teratogenic effects were seen in the rat.
Danish: Ved en høj toksisk dosis hos moderdyr (over 40 gange den anbefalede humane dosis) blev der set teratogene påvirkninger hos rotter.
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Danish: Dette produktresume og denne indlægsseddel er resultatet af en referral-procedure.
English: Other medicines and X
Danish: Brug af anden medicin og {X}
English: If taken after meals, absorption of the drug is somewhat delayed.
Danish: Hvis det indtages efter måltider, er absorptionen af lægemidlet noget forsinket.
English: It is important to ask your doctor or pharmacist if {Tradename} is safe for you when you are taking any other medicines, including medicines obtained without prescription.
Danish: Det er vigtigt, at du spørger lægen eller på apoteket, om det er sikkert for dig at tage {Handelsnavn}, hvis du tager andre lægemidler, herunder lægemidler købt uden recept.
English: Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should consult their physician.
Danish: Behandling med domperidon bør stoppes, hvis der opstår tegn eller symptomer, der kan være forbundet med hjertearytmi, og patienterne skal informeres om at kontakte deres læge.
English: [The paragraph below is to be implemented where the marketing authorisation currently includes relief of the symptoms of nausea and vomiting in children under 12 years of age and adolescents weighing less than 35 kg:]
Danish: [Nedenstående afsnit skal indføjes, hvis den nuværende markedsføringstilladelse omfatter lindring af symptomer på kvalme og opkastnig hos børn under 12 år og unge, der vejer mindre end 35 kg:]
English: Domperidone has been associated with prolongation of the QT interval on the electrocardiogram.
Danish: Domperidon er blevet forbundet med forlængelse af QT-intervallet i elektrokardiogrammet.
English: Since very little unchanged drug (approximately 1%) is excreted via the kidneys, it is unlikely that the dose of a single administration needs to be adjusted in patients with renal insufficiency.
Danish: Da der udskilles meget lidt uomdannet lægemiddel via nyrerne (ca. 1 %), er det usandsynligt, at dosisjustering er nødvendig ved en enkelt administration til patienter med nedsat nyrefunktion.
English: Domperidone should be used during breast feeding only if your physician considers this clearly necessary.
Danish: Domperidon må kun anvendes under amning, hvis din læge mener, at det er helt nødvendigt.
English: It is advisable to ask your doctor for advice in case of prolonged treatment as you may need to take a lower dose or take this medicine less often, and your doctor may want to examine you regularly.
Danish: Det er tilrådeligt, at du spørger din læge til råds ved langvarig behandling, da du måske er nødt til at tage en lavere dosis eller tage dette lægemiddel sjældnere.
English: Although domperidone's bioavailability is enhanced in normal subjects when taken after a meal, patients with gastro-intestinal complaints should take domperidone 15 - 30 minutes before a meal.
Danish: Skønt domperidons biotilgængelighed øges hos normale forsøgspersoner, når det tages efter et måltid, bør patienter med gastrointestinale lidelser tage domperidon 15-30 minutter før et måltid.
English: Section 4.3 Contraindications [This section should be amended to include the following contraindications] Domperidone is contraindicated in the following situations:
Danish: 4.3 Kontraindikationer [Dette punkt bør ændres til at omfatte følgende kontraindikationer] Domperidon er kontraindiceret i følgende situationer:
English: Section 5.1 Pharmacodynamic properties
Danish: 5.1 Farmakodynamiske egenskaber
English: Section 4.5 Interaction with other medicinal products and other forms of interaction [This section should be amended to include the following wording] Increased risk of occurrence of QT-interval prolongation, due to pharmacodynamic and/or pharmacokinetic interactions.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion [Dette punkt skal ændres, så det indeholder følgende ordlyd] På grund af farmakodynamiske og/eller farmakokinetiske interaktioner er der øget risiko for forlænget QT-interval.
English: Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of domperidone to prolong the QTc interval in humans.
Danish: Elektrofysiologiske in vitro- og in vivo-studier indikerer, at der overordnet er en moderat risiko for, at domperidon forlænger QTc-intervallet hos mennesker.
English: In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of domperidone can rise up to 3-fold.
Danish: I forbindelse med hæmning af metaboliseringen via CYP3A4 kan plasmakoncentrationen af frit domperidon stige op til 3 gange.
English: Section 5.3 Preclinical safety data
Danish: 5.3 Prækliniske sikkerhedsdata
English: Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35 kg
Danish: Nyfødte, spædbørn, børn (under 12 år) og unge, der vejer mindre end 35 kg
English: Do not take a double dose to make up for a forgotten dose.
Danish: Tag ikke en dobbelt dosis som erstatning for den glemte dosis.
English: Section 3 ‘How to take X' [This section should be amended to include the below wording] Follow these instructions closely unless your doctor has advised you otherwise.
Danish: ‘Sådan skal du tage {X}' [Dette punkt skal rettes, så det indeholder følgende ordlyd] Følg disse anvisninger nøje, medmindre din læge har rådgivet dig om noget andet.
English: <Tablets>, <orodispersible tablets> and <suppositories>are not suitable for children weighing less than 35 kg.
Danish: <Tabletter>, <smeltetabletter> og <suppositorier> er ikke egnede til børn, der vejer under 35 kg.
English: Patients should be advised to promptly report any cardiac symptoms.
Danish: Patienterne skal informeres om straks at rapportere eventuelle hjertesymptomer.
English: A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre, eller behandling med domperidon afbrydes/undlades, idet der tages hensyn til fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Reduced gastric acidity impairs the absorption of domperidone.
Danish: Nedsat gastrisk surhedsgrad forringer absorptionen af domperidon.
English: • bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin,
Danish: • bakterielle infektioner, specielt erythromycin, clarithromycin, telithromycin, moxifloxacin,
English: o certain antipsychotics (e.g., haloperidol, pimozide, sertindole) o certain antidepressants (e.g., citalopram, escitalopram) o certain antibiotics (e.g. , erythromycin, levofloxacin, moxifloxacin, spiramycin) o certain antifungal agents (e.g., pentamidine) o certain antimalarial agents (in particular halofantrine, lumefantrine) o certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride) o certain antihistaminics (e.g., mequitazine, mizolastine) o certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine) o certain other medicines (e.g., bepridil, diphemanil, methadone) (see section 4.3).
Danish: o visse antipsykotika (f.eks. haloperidol, pimozid, sertindol) o visse antidepressiva (f.eks. citalopram, escitalopram) o visse antibiotika (f.eks. erythromycin, levofloxacin, moxifloxacin, spiramycin) o visse svampemidler (f.eks. pentamidin) o visse malariamidler (især halofantrin, lumefantrin) o visse lægemidler mod gastrointestinale lidelser (f.eks. cisaprid, dolasetron, prucaloprid) o visse antihistaminer (f.eks. mequitazin, mizolastin) o visse lægemidler, der bruges mod cancer (f.eks. toremifen, vandetanib, vincamin) o visse andre lægemidler (f.eks. bepridil, diphemanil, methadon) (se pkt.
English: A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.
Danish: En højere risiko blev observeret hos patienter over 60 år, patienter, der dagligt tog højere doser end 30 mg, og patienter, der samtidig tog lægemidler, der forlængede QT, eller CYP3A4-hæmmere.
English: Tell your doctor or pharmacist if you are taking drugs to treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/HIV (see section other medicines and X).
Danish: Fortæl din læge eller apotekspersonalet, hvis du tager medicin til behandling af infektioner (svampeinfektioner eller bakterie-infektioner), og/eller hvis du har hjerteproblemer eller AIDS/HIV (se afsnittet ”Brug af anden medicin og {X}”).
English: Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.
Danish: Elektrolytforstyrrelser (hypokaliæmi, hyperkaliæmi, hypomagnesiæmi) eller bradykardi er kendt for at være faktorer, der øger risikoen for proarytmi.
English: Subjects with severe hepatic impairment were not studied.
Danish: Forsøgspersoner med alvorligt nedsat leverfunktion er ikke blevet undersøgt.
English: Adults, and adolescents (12 years of age and older and weighing 35 kg or more) [Tablets (Film-coated, Coated, Scored coated, Effervescent, Chewable), Orodispersible tablets, capsules]
Danish: Voksne og unge (i alderen 12 år og derover, og som vejer 35 kg eller mere) [Tabletter (Filmovertrukne, overtrukne, overtrukne med delekærv, brusetabletter, tyggetabletter), smeltetabletter, kapsler]
English: If you take more X than you should
Danish: Hvis du har taget for mange X
English: Oral suspension [Appropriate measure device such as dosing cup must be provided with the product, and instructions for use must be included]
Danish: Oral suspension [Passsende måledevice såsom en doseringskop skal følge med produktet, og vejledning i brugen skal inkluderes]
English: ▼This medicinal product is subject to additional monitoring.
Danish: PRODUKTRESUME ▼ Dette lægemiddel er underlagt supplerende overvågning.
English: In the event of overdose, symptomatic treatment could be implemented.
Danish: I tilfælde af overdosering kan det være nødvendigt at behandle symptomerne.
English: In subjects with severe renal insufficiency (creatinine clearance<30 ml/min/1.73m2) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers.
Danish: Hos forsøgspersoner med alvorlig nyreinsufficiens (kreatininclearance <30 ml/min/1,73m2) blev domperidons halveringstid øget fra 7,4 til 20,8 timer, men plasmaniveauerne af lægemidlet var lavere end hos raske frivillige forsøgspersoner.
English: Caution should be exercised in case of QTc prolongation risk factors in breast-fed infants.
Danish: Der skal udvises forsigtighed i tilfælde af risikofaktorer for QTcforlængelse hos det ammede spædbarn.
English: [Suppositories] One 30 mg suppository inserted into the rectum two times per day.
Danish: [Suppositorier] En 30 mg suppositorie i endetarmen to gange dagligt.
English: • co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5)
Danish: • samtidig administration af potente CYP3A4-hæmmere (uanset deres QT-forlængende virkning) (se pkt.
English: This study included a placebo, an active comparator and a positive control and was conducted in healthy subjects with up to 80 mg per day 10 or 20 mg administered 4 times a day of domperidone.
Danish: Dette studie omfattede placebo, en aktiv komparator og en positiv kontrol og blev gennemført hos raske forsøgspersoner med op til 80 mg domperidon per dag, 10 eller 20 mg indgivet fire gange dagligt.
English: The Cmax and AUC values of domperidone increased proportionally with dose in the 10 mg to 20 mg dose range.
Danish: Domperidon-Cmax og -AUC øgedes proportionalt med dosis i dosisintervallet 10 mg til 20 mg.
English: [This following wording should be reflected in this section]
Danish: [Følgende ordlyd skal afspejles i dette punkt]
English: • fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole
Danish: • svampeinfektioner såsom azol-svampemidler, specielt oral ketoconazol, fluconazol eller voriconazol
English: Do not take more than 30 mg per day.
Danish: Tag ikke mere end 30 ml per dag.
English: Section 4.2 Posology and method of administration [This section should be amended to reflect the following wording, as applicable:] <X> should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
Danish: 4.2 Dosering og administration [Dette punkt skal ændres til at reflektere følgende ordlyd:] <X> skal anvendes i den laveste effektive dosis til at kontrollere kvalme og opkastning og i så kort tid som muligt.
English: While taking domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, loss of consciousness.
Danish: Mens du tager domperidon, skal du kontakte din læge, hvis du oplever forstyrrelser i hjerterytmen, såsom hjertebanken, får åndedrætsbesvær eller bliver bevidstløs.
English: Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8).
Danish: Epidemiologiske studier har vist, at domperidon var forbundet med en øget risiko for alvorlige ventrikulære arytmier eller pludselig hjertedød (se pkt.
English: Subjects with mild hepatic impairment have a somewhat lower systemic exposure than healthy subjects based on Cmax and AUC, with no change in protein binding or terminal half-life.
Danish: Baseret på Cmax og AUC har forsøgspersoner med let nedsat leverfunktion en noget lavere systemisk eksponering end raske forsøgspersoner uden ændring i proteinbinding eller terminal halveringstid.
English: Not known: ventricular arrhythmias, QTc prolongation, Torsade de Pointes, sudden cardiac death (see section 4.4)
Danish: Ikke kendt: ventrikulære arytmier, QTc-forlængelse, torsades de pointes, pludselig hjertedød (se pkt.
English: Due to the need for accurate dosing, tablets, effervescent granules and suppositories are unsuitable for use in children and adolescents weighing less than 35 kg.
Danish: Da præcis dosering er nødvendig, er tabletter, brusegranulater og suppositorier uegnede til børn og unge, der vejer mindre end 35 kg.
English: • depression (e.g., citalopram, escitalopram)
Danish: • depression (f.eks. citalopram, escitalopram)
English: Concomitant use of the following substances requires caution in use Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor).
Danish: Samtidig anvendelse af følgende lægemidler kræver forsigtighed Forsigtighed med bradykardi- og hypokaliæmi-inducerende lægemidler, såvel som med følgende makrolider, der er involveret i forlænget QT-interval: azithromycin og roxithromycin (clarithromycin er kontraindiceret, da det er en potent CYP3A4-hæmmer).