FrancophonIA/ELRC3.0 huggingface dataset:
English: Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell, swelling and/or pain at the infusion site.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter) Hovedpine, svimmelhed, kvalme, opkastninger, diarré, muskelsmerter, knogle- og/eller ledsmerter, smerter i ryg, arme eller ben, influenzalignende symptomer (fx træthed, kuldegysninger, led- og muskelsmerter), kuldegysninger, følelse af træthed og manglende interesse, svækkelse, smerter, sygdomsfølelse, hævelse og/eller smerte ved infusionsstedet.
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Danish: Ikke almindelig Nakkesmerter, stivhed i bevægeapparatet, hævelse af led, muskelkramper, muskuloskeletale smerter i brystregionen, muskuloskeletale smerter, ledstivhed, artrit, muskelsvækkelse
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 Class effects)
Danish: Sjældne tilfælde af dialysekrævende nyresvigt og sjældne tilfælde med letal udgang er rapporteret hos patienter med forudeksisterende nedsat nyrefunktion eller andre risikofaktorer som fremskreden alder, samtidig anvendelse af nefrotoksiske lægemidler, samtidig anvendelse af diuretika eller dehydrering efter behandlingen med Aclasta (se pkt.
English: Aclasta 5 mg solution for infusion
Danish: Aclasta 5 mg infusionsvæske, opløsning
English: ONJ has been reported in the post-marketing setting in patients receiving Aclasta (zoledronic acid) for osteoporosis (see section 4.8).
Danish: Osteonekrose af kæberne er blevet rapporteret efter markedsføring hos patienter behandlet med Aclasta (zoledronsyre) for osteoporose (se pkt.
English: A randomised, double-blind, placebo-controlled study was conducted in paediatric patients aged 5 to 17 years treated with glucocorticoids who had decreased bone mineral density (lumbar spine BMD Zscore of -0.5 or less) and a low impact/fragility fracture.
Danish: Der er gennemført et randomiseret, dobbeltblindet, placebo-kontrolleret studie med pædiatriske patienter i alderen 5-17 år i behandling med glukokortikoider.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Aclasta (zoledronic acid) for osteoporosis.
Danish: Efter markedsføring af produktet er en bivirkning kaldet osteonekrose i kæben (knogleskade i kæben) blevet set hos patienter behandlet med Aclasta (zoledronsyre) mod osteoporose.
English: Aclasta is contraindicated during breast-feeding (see section 4.3).
Danish: Aclasta er kontraindiceret til ammende kvinder (se pkt.
English: Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastro-oesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Danish: Kvalme, opkastning, diarré Ikke almindelig Dyspepsi, øvre mavesmerter, mavesmerter, gastroøsofageal reflukssygdom, forstoppelse, mundtørhed, øsofagit, tandpine, gastrit
English: Uncommon Influenza, nasopharyngitis Blood and lymphatic system disorders Uncommon Anaemia Immune system disorders
Danish: Infektioner og parasitære sygdomme Ikke almindelig Influenza, nasofaryngit Blod og lymfesystem
English: 1 bottle contains 5 mg zoledronic acid (as monohydrate).
Danish: 1 flaske indeholder 5 mg zoledronsyre (som monohydrat).
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Aclasta for the treatment of postmenopausal osteoporosis.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter) Uregelmæssig hjerterytme (puls), kaldet atrieflimren, er set hos patienter behandlet med Aclasta for post-menopausal osteoporose.
English: What Aclasta looks like and contents of the pack Aclasta is a clear and colourless solution.
Danish: Aclasta er en klar, farveløs væske.
English: While being treated with Aclasta, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du er i behandling med Aclasta, skal du holde en god mundhygiejne (inkl.
English: Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as pyrexia, vomiting and diarrhoea
Danish: Ikke almindelig Perifert ødem, tørst, akut-fase reaktion, ikke-kardielle brystsmerter
English: Each ml of the solution contains 0.05 mg zoledronic acid (as monohydrate).
Danish: Hver ml af infusionsvæsken indeholder 0,05 mg zoledronsyre (som monohydrat).
English: Each bottle of 100 ml contains 5 mg zoledronic acid (as monohydrate).
Danish: Hver flaske på 100 ml indeholder 5 mg zoledronsyre (som monohydrat).
English: In the HORIZON-RFT study Aclasta treatment significantly increased BMD at the total hip and femoral neck relative to treatment with placebo at all timepoints.
Danish: I HORIZON-RFT-studiet forøgede Aclastabehandling signifikant BMD i forhold til placebo ved hofteledet og lårbenshalsen ved alle tidspunkter (12, 24 og 36 måneder).
English: Renal impairment has been observed following the administration of Aclasta (see section 4.8), especially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see section 4.5), or dehydration occurring after Aclasta administration.
Danish: 4.8), specielt hos patienter med eksisterende nedsat nyrefunktion eller andre risici såsom fremskreden alder, samtidig anvendelse af nefrotoksiske lægemidler, samtidig dialysebehandling (se pkt.
English: Tel: +40 21 40751 60
Danish: Sandoz SRL Tel: +40 21 40751 60
English: Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Danish: Hver flaske med 100 ml opløsning indeholder 5 mg zoledronsyre (som monohydrat).
English: Respiratory, thoracic and mediastinal disorders
Danish: Infusionsvæske, opløsning
English: What Aclasta is and what it is used for What you need to know before you are given Aclasta How Aclasta is given
Danish: Det skal du vide, før du begynder at blive behandlet med Aclasta Sådan får du Aclasta
English: Relative reduction in fracture incidence %
Danish: Relativ reduktion af frakturincidens % (CI)
English: Hypophosphataemia
Danish: Atrieflimren
English: Oral use blister (UPVC/ Monochlorotrifluor ethylene)
Danish: Oral anvendelse Blister (UPVC) monoclorotrifluorethylen
English: 0.45 mg / 20 mg
Danish: DUAVIVE 0,45 mg/20 mg Tablet med modificeret udløsning
English: DUAVIVE
Danish: Pakningsstørrelse
English: EU Number
Danish: EU-procedurenummer Særnavn Styrke
English: This risk persists until significant remission occurs.
Danish: Denne risiko varer ved, indtil der opstår signifikant remission.
English: Long-term carcinogenicity studies have not been performed.
Danish: Der er ikke gennemført langtidsvarende karcinogenicitetsstudier.
English: Preferred Term
Danish: Foretrukket term
English: Your liver may be affected.
Danish: Din lever kan være påvirket.
English: Do this even if there are no signs of discomfort or poisoning.
Danish: Gør det, selvom der ikke er nogen tegn på ubehag eller forgiftning.
English: In such cases, it is important to contact your doctor who probably will change your medication.
Danish: I sådanne tilfælde er det vigtigt, at du kontakter din læge, som sandsynligvis vil ændre din medicin.
English: Further treatment with oral formulation:
Danish: Videre behandling med orale formuleringer:
English: Treatment 1.
Danish: Behandling 1.
English: The mechanism leading to this risk is unknown.
Danish: Mekanismen bag denne risiko er ukendt.
English: Other isozymes involved are
Danish: Andre involverede isozymer er
English: Close monitoring even in apparently uncomplicated cases.
Danish: Tæt overvågning selv i tilsynelandende ukomplicerede tilfælde.
English: If you stop your treatment too soon, your symptoms may return.
Danish: Hvis du stopper behandlingen for tidligt, kan dine symptomer vende tilbage.
English: This appears to be associated with the antidepressant activity.
Danish: Dette lader til at være forbundet med den antidepressive aktivitet.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Danish: Disse produktoplysninger er resultatet af den referral-procedure, som Kommissionens beslutning relaterer til.
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: Produktoplysningerne kan efterfølgende opdateres efter behov af den relevante myndighed i medlemsstaten i samarbejde med referencemedlemsstaten, hvor det er passende, i overensstemmelse med procedurerne, som er beskrevet i kapitel 4 titel III i direktiv 2001/83/EF.
English: Sudden occurrence of CNS depression.
Danish: Pludselig forekomst af CNS-depression.
English: In many patients, therapy may be needed for several years.
Danish: Hos mange patienter kan behandling være påkrævet i flere år.
English: Symptoms of overdose include:
Danish: Symptomer på overdosis inkluderer:
English: • If you are a young adult.
Danish: • Hvis du er ung.
English: It may be necessary to adjust the dosage of these drugs.
Danish: Det kan være nødvendigt at justere dosis af disse lægemidler.
English: There is considerably individual variability in response to overdose.
Danish: Der er betydelig individuel variation i respons på overdosering.
English: Patients with special risks
Danish: Patienter med særlige risici
English: • if you have taken MAOIs within the last 14 days
Danish: • hvis du har taget en MAO-hæmmer inden for de seneste 14 dage
English: ATC code: N 06 AA 09
Danish: ATC-kode: N 06 AA 09
English: For further information please see section 2.
Danish: Se punkt 2 for yderligere oplysninger.
English: Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths.
Danish: Ikke alle doseringsskemaer kan opnås med alle lægemiddelformer/styrker.
English: Carton/Label
Danish: Karton/etikette
English: Oral administration of tablets results in maximum serum levels in about 4 hours.
Danish: Oral administration af tabletter resulterer i maksimale serumkoncentrationer i løbet af ca. 4 timer.
English: Deaths by deliberate or accidental overdosage have occurred with this class of medicament.
Danish: Dødsfald efter forsætlig eller utilsigtet overdosering har fundet sted med denne type medikamenter.
English: • feeling of inner restlessness and a compelling need to be in constant motion
Danish: • fornemmelse af indre rastløshed og et tvingende behov for at være i konstant bevægelse
English: The maximum period of treatment course should not exceed 3 months.
Danish: Den maksimale behandlingsperiode må ikke overstige 3 måneder.
English: Consider a 50% reduction of the recommended starting dose.
Danish: Overvej at reducere den anbefalede startdosis med 50 %.
English: Respiratory depression.
Danish: Respirationsdepression.
English: Alopecia, photosensitivity reaction.
Danish: Alopeci, fotosensibilitet
English: Saroten and associated names is for oral use.
Danish: Saroten og relaterede navne er til oral anvendelse.
English: The reason for the effect on fertility is unknown.
Danish: Årsagen til indvirkningen på fertilitet kendes ikke.
English: • uncontrolled movements
Danish: • ukontrollerede bevægelser
English: Your doctor will re-evaluate your treatment after 3 months and if needed perform a new ECG.
Danish: Din læge vil vurdere behandlingen efter 3 måneder og om nødvendigt tage et nyt EKG.
English: • if you have taken moclobemide the day before
Danish: • hvis du tog moclobemid dagen i går
English: Talk with your physician in case you have the impression that the effect of X is too strong or weak.
Danish: Tal med din læge, hvis du føler, at virkningen af {X} er for kraftig eller for svag.
English: This medicine should not be used for children below 6 years of age.
Danish: Dette lægemiddel må ikke anvendes til børn under 6 år.
English: You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Danish: Du kan eventuelt bede dem om at fortælle dig, hvis de synes, at din depression eller angst bliver værre, eller hvis de er bekymrede over ændringer i din opførsel.
English: Treatment is symptomatic and supportive.
Danish: Behandlingen er symptomatisk og understøttende.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: Det er en generel klinisk erfaring, at risikoen for selvmord kan øges i de tidlige stadier af bedringen.
English: As with other medicines for the treatment of depression it may take a few weeks before you feel any improvement.
Danish: Som for andre lægemidler til behandling af depression kan der gå et par uger, før du kan mærke en bedring.
English: This medicine is taken every evening as a single daily dose.
Danish: Du skal tage denne medicin tages hver aften som en enkelt daglig dosis.
English: An increased risk of bone fractures has been observed in patients taking this type of medicines.
Danish: En øget risiko for knoglefrakturer er set hos patienter, som tager denne type lægemiddel.
English: • have or had a problem where your heart cannot pump the blood round your body as well as it should (a condition called heart failure),
Danish: • har eller har haft et problem, hvor dit hjerte ikke kan pumpe blodet rundt i kroppen så godt, som det burde (en tilstand kaldet hjertesvigt)
English: A more suitable dosage form should be used for this age group.
Danish: En anden, mere hensigtsmæssig lægemiddelform skal benyttes til denne aldersgruppe.
English: • slurred or slow speech
Danish: • sløret eller langsom tale
English: The systemic bioavailability is about 50% of the intravenous injection.>
Danish: Den systemiske biotilgængelighed er omkring 50 % af biotilgængeligheden efter intravenøs injektion.>
English: The metabolism is subject to genetic polymorphism.
Danish: Metaboliseringen er genstand for genetisk polymorfisme.
English: Examine for clinical features.
Danish: Undersøg for kliniske karakteristika.
English: In case of sufficient effect, the dose should be as low as possible.
Danish: Hvis virkningen er tilstrækkelig, skal dosis være så lav som muligt.
English: Treatment in respirator is advised to prevent a possible respiratory arrest.
Danish: Respiratorbehandling tilrådes for at forhindre muligt respirationsstop.
English: You may be more likely to think like this:
Danish: Du kan have øget risiko for sådanne tanker:
English: These symptoms can be the first signs that your blood or bone marrow may be affected.
Danish: Disse symptomer kan være de første tegn på, at medicinen har påvirket dit blod eller din knoglemarv.
English: Although these investigations revealed partially contradictory results, particularly a potential to induce chromosome aberrations cannot be excluded.
Danish: Selv om disse studier gav delvist modstridende resultater, kan specielt et potentiale for at inducere kromosomafvigelser ikke udelukkes.
English: Tell your doctor if you have, or have had in the past, any medical problems, especially if you have
Danish: Fortæl lægen, hvis du har eller tidligere har haft helbredsproblemer, især hvis du har
English: Contact your doctor or nearest hospital casualty department immediately.
Danish: Kontakt straks lægen eller den nærmeste skadestue.
English: The maintenance dose is the lowest effective dose.
Danish: Vedligeholdelsesdosis er den laveste effektive dosis.
English: • have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood
Danish: • har en tilstand, som medfører, at du har et lavt niveau af kalium eller magnesium eller et højt niveau af kalium i blodet
English: This is characterized by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity.
Danish: Dette er karakteriseret ved overstrømmende og hurtigt skiftende ideer, overdreven opstemthed og usædvanlig stor fysisk aktivitet.
English: The plasma protein binding is about 95%.
Danish: Plasmaproteinbindingen er omkring 95 %.
English: Swallow the tablets with a drink of water.
Danish: Slug tabletterne med et glas vand.
English: Continuous ECG-monitoring of cardiac function for 3-5 days.
Danish: Kontinuerlig EKG-monitorering af hjertefunktionen i 3-5 dage.
English: The maximum plasma concentration is reached only after 1 to 5 (-8) hours.
Danish: Den maksimale plasmakoncentration nås først efter 1-5 (-8) timer.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har vist reproduktionstoksicitet (se punkt 5.3).
English: • low sodium concentration in the blood
Danish: • lav natriumkoncentration i blodet
English: The underlying illness may persist for a long time.
Danish: Din sygdom kan vare i lang tid.
English: The renal elimination of unchanged amitriptyline is insignificant (about 2%).
Danish: Den renale elimination af uomdannet amitriptylin er ubetydelig (ca. 2 %).
English: If you stop taking X
Danish: Hvis du holder op med at tage {X}
English: In children under 6 years of age.
Danish: Børn under 6 år.
English: The dose should be increased gradually.
Danish: Dosis skal øges gradvist.
English: • are taking any other medication that may cause heart problems, or
Danish: • tager anden medicin, som kan forårsage hjerteproblemer, eller
English: Lowered consciousness progressing into coma.
Danish: Nedsat bevidsthed, som kan udvikle sig til koma.
English: Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase.
Danish: Da overdosering ofte er bevidst, kan patienter forsøge selvmord med andre midler i bedringsfasen.
English: Do not use this medicine after the expiry date which is stated on the card box and ampoule.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og ampullen.
English: • increased production of breast milk or breast milk outflow without breast feeding
Danish: • øget produktion af brystmælk eller udflåd af brystmælk uden amning
English: The dose can be taken once daily, or be divided into two doses.
Danish: Dosis kan tages en gang dagligt eller fordeles på to doser.
English: Patients who display signs of toxicity should be monitored for a minimum of 12 hours.
Danish: Patienter, der viser tegn på toksicitet, skal overvåges i mindst 12 timer.
English: This medicine is used to treat:
Danish: Denne medicin bruges:
English: Cases of QT interval prolongation and arrhythmia have been reported during the post-marketing period.
Danish: Tilfælde af QT-intervalforlængelse og arytmi er blevet rapporteret efter markedsføring.
English: • shakiness of hands or other body parts
Danish: • rysten på hænder eller andre dele af kroppen
English: Widening of the QRS-complex usually correlates well with the severity of the toxicity following acute overdoses.
Danish: Breddeforøgelsen af QRS-komplekset korrelerer sædvanligvis godt med toksicitetsgraden efter akut overdosering.
English: Elderly patients are particularly susceptible to orthostatic hypotension.
Danish: Ældre patienter er særligt følsomme for ortostatisk hypotension.
English: This medicine should not be given to children or adolescents for treatment of depression.
Danish: Medicinen må ikke gives til børn eller unge til behandling af depression.
English: Your doctor will most likely choose to initiate your treatment with Saroten film-coated tablets before starting treatment with X.
Danish: Din læge vil højst sandsynlig vælge at starte din behandling med Saroten filmovertrukne tabletter, inden du starter behandling med {X}.
English: • movement disorders (involuntary movements or decreased movements)
Danish: • bevægelsesforstyrrelser (ufrivillige bevægelser eller færre bevægelser)
English: It is generally recommended to initiate treatment in the lower dose range as recommended for adult.
Danish: Det anbefales generelt at starte behandling i det lavere dosisområde, som anbefales til voksne.
English: The score line facilitates breaking of the tablet into 4 parts (12.5 mg/part).
Danish: Kærvlinjerne gør det lettere at dele tabletten i 4 dele (12,5 mg/del).
English: • If you have previously had thoughts about killing or harming yourself.
Danish: • Hvis du tidligere har haft selvmordstanker eller tanker om at gøre skade på dig selv.
English: Do not drive or work with tools or machinery if you are affected.
Danish: Undlad at føre motorkøretøj eller betjene værktøj eller maskiner, hvis du har disse bivirkninger.
English: Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient.
Danish: Regelmæssig vurdering anbefales for at bekræfte, at behandlingen fortsat er hensigtsmæssig for patienten.
English: Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Danish: Nøje overvågning af patienterne, navnligt patienter med høj risiko, skal ledsage den medicinske behandling, særligt ved behandlingsstart og efter dosisændringer.
English: Contraindicated combinations
Danish: Kontraindicerede kombinationer
English: Elderly patients over 65 years of age:
Danish: Ældre patienter over 65 år
English: In the listing below the following convention is used:
Danish: Følgende konvention er brugt i tabellen nedenfor:
English: Do not stop the treatment without consulting your doctor first.
Danish: Du må ikke stoppe behandlingen uden først at tale med lægen.
English: X with alcohol
Danish: Brug af {X} sammen med alkohol
English: Side effects listed below have been reported in the following frequencies:
Danish: Nedenstående bivirkninger er rapporteret med følgende hyppigheder:
English: Generally, the lowest effective dose should be used for the shortest duration required to treat the symptoms.
Danish: Generelt bør den laveste effektive dosis, der er nødvendig for at behandle symptomerne, anvendes i den kortest mulige periode.
English: Treatment is symptomatic and should therefore be continued for an appropriate length of time.
Danish: Behandlingen er symptomatisk og skal derfor fortsættes i en passende periode.
English: You should immediately have an eye examination before the treatment with this medicine can be continued.
Danish: Du skal straks få foretaget en øjenundersøgelse, før behandling med lægemidlet kan fortsætte.
English: Not known (cannot be estimated from the available data).
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: The pellets must not be chewed.>
Danish: Pellets må ikke tygges.>
English: Talk to your doctor about the duration of your treatment and continue to take this medicine for as long as your doctor recommends.
Danish: Tal med din læge om varigheden af din behandling og fortsæt med at tage medicinen, så længe som lægen anbefaler det.
English: • dry mouth and tongue
Danish: • tør mund og tunge
English: This condition may be signs of acute glaucoma.
Danish: Denne tilstand kan være tegn på akut glaukom.
English: If a dose increase is required this should be done stepwise within 3 to 7 days.
Danish: Hvis det er nødvendigt at øge dosis, bør dette gøres trinvis i løbet af 3 til 7 dage.
English: Continue to take this medicine for as long as your doctor recommends.
Danish: Fortsæt med at tage din medicin, så længe som din læge anbefaler det.