FrancophonIA/ELRC3.0 huggingface dataset:
English: Karil 100 I.E. Injektionslösung solution for injection intravenous use, intramuscular use, subcutaneous use
Danish: Karil 100 I.E. Injektionslösung
English: 25, ROONSTRASSE D 90429 NUERNBERG
Danish: NOVARTIS PHARMA GMBH 25, ROONSTRASSE D 90429 NUERNBERG
English: ALAPIS ABEE AYTOKRATOROS NIKOLAOU 2
Danish: AYTOKRATOROS NIKOLAOU 2 ATHENS 17671
English: Calcitonin-ratiopharm 100 I.E. Ampullen solution for injection intravenous use, intramuscular use, subcutaneous use
Danish: Calcitonin-ratiopharm 100 I.E. Ampullen 100 IE/1 ml
English: EU Number
Danish: MF (EU)-nummer
English: (Invented) name
Danish: (Særnavn) Navn Styrke
English: Pack size bottle (HDPE)
Danish: Beholder (HDPE)
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Administration Emballage Pakningsstørrelse
English: Medicinal Product no longer authorised
Danish: Lægemidlet er ikke længere autoriseret til salg hætteglas (glas) 0.8 ml
English: 1 pre-filled pen + 1 alcohol pad in a blister
Danish: 1 fyldt pen + 1 alkoholserviet i blister
English: 1 vial + 1 syringe + 2 alcohol pads
Danish: 1 hætteglas + 1 injekstionssprøjte + 2 alkoholservietter
English: 1 pre-filled syringe with needleguard + 1 alcohol pad
Danish: 1 fyldt injektionssprøjte med beskyttelseshætte + 1 alkoholserviet
English: 1 pre-filled syringe + 1 alcohol pad
Danish: 4 fyldte injektionsspørjter + 4 alkoholservietter
English: Preferred Term
Danish: Foretrukken term
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid dette lægemiddel nøjagtigt efter lægens anvisning.
English: In doubtful cases, patients should be referred to a neurologist for appropriate investigations.
Danish: I tvivlstilfælde skal patienten henvises til en neurolog for relevante undersøgelser.
English: The majority of the patients recovered within 4 months after trimetazidine withdrawal.
Danish: Størstedelen af patienterne restituerede inden for 4 måneder efter seponering af trimetazidin.
English: Children and adolescents <invented name> is not recommended in children aged below 18 years.
Danish: Børn og teenagere <(Sær)navn> anbefales ikke til børn og teenagere under 18 år.
English: If you have kidney problems or if you are older than 75 years old, your doctor may adjust the recommended dose.
Danish: Hvis De har dårlige nyrer, eller hvis De er over 75 år, kan Deres læge justere den anbefalede dosis.
English: These cases have a low incidence and are usually reversible after treatment discontinuation.
Danish: Disse tilfælde har en lav incidens og er almindeligvis reversible efter seponering af behandlingen.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apoteket til råds, før De tager dette lægemiddel.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Rettelser til relevante afsnit i produktresumé og indlægsseddel
English: Rare:
Danish: Sjældne:
English: A significant difference was also evidenced for the time to onset of angina pectoris (p=0.049).
Danish: Der sås også en signifikant forskel i tiden til angina pectoris-symptomer (p = 0,049).
English: Severe reduction in number of white blood cells which makes infections more likely, reduction in blood platelets, which increases risk of bleeding or bruising.
Danish: Et alvorligt fald i antallet af hvide blodlegemer, hvilket gør infektioner mere sandsynlige, fald i antallet af blodplader, hvilket øger risikoen for blødning eller blå mærker.
English: If parkinsonian symptoms persist more than 4 months after drug discontinuation, a neurologist opinion should be sought.
Danish: Hvis parkinson-symptomerne vedvarer i mere end 4 måneder efter seponering af lægemidlet, skal der henvises til en neurolog.
English: Sleep disorders (insomnia, drowsiness)
Danish: Søvnforstyrrelser (insomni, træthed)
English: Anti-ischemic effects are achieved without concomitant haemodynamic effects.
Danish: Der opnås en anti-iskæmisk virkning uden en samtidig hæmodynamisk virkning.
English: The safety and efficacy of trimetazidine in children aged below 18 years have not been established.
Danish: Pædiatrisk population Trimetazidins sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: No significant difference between groups could be found for the other secondary endpoints (total exercise duration, total workload and clinical endpoints).
Danish: Der var ikke nogen signifikant forskel grupperne imellem for de sekundære endepunkter (samlet varighed af funktionstest, samlet belastning og kliniske endepunkter).
English: 4.7 Effects on ability to drive and use machines [the currently approved wording of this section should be deleted and replaced by the following]
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner [den aktuelt godkendte tekst i dette afsnit slettes og erstattes af følgende]
English: This medicine may make you feel dizzy and drowsy that may affect your ability to drive or use machinery.
Danish: Dette lægemiddel kan gøre Dem svimmel og træt, hvilket kan påvirke Deres evne til at føre motorkøretøj eller betjene maskiner.
English: Agranulocytosis Thrombocytopenia Thrombocytopenic purpura
Danish: Agranulocytose Trombocytopeni Trombocytopenisk purpura
English: In an ischaemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the β-oxidation process.
Danish: I en iskæmisk celle kræver den energi, der er opnået under glucoseoxidation, mindre iltforbrug end i -oxidationsprocessen.
English: 4.3 Contraindications [the currently approved contraindications should be deleted and replaced by the following]
Danish: 4.3 Kontraindikationer [de aktuelt godkendte kontraindikationer slettes og erstattes af følgende]
English: Acute generalized exanthematus pustulosis (AGEP), angioedema
Danish: Akut generaliseret eksantematøs pustulose (AGEP), angioødem
English: 5.1 Pharmacodynamic properties [the wording below should be inserted]
Danish: 5.1 Farmakodynamiske egenskaber [følgende tekst indsættes]
English: Trimetazidine inhibits β-oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation.
Danish: Trimetazidin hæmmer -oxidation af fedtsyrer ved at blokere langkædet 3-ketoacyl-CoA thiolase, hvilket øger glucoseoxidationen.
English: Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients.
Danish: Trimetazidin kan forårsage eller forværre parkinson-symptomer (tremor, akinesi, hypertoni), som der regelmæssigt skal undersøges for, især hos ældre patienter.
English: Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischaemia.
Danish: Potensering af glucoseoxidation optimerer cellernes energiprocesser, hvorved der opretholdes korrekt energimetabolisme ved iskæmi.
English: Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function (see section 5.2).
Danish: Ældre patienter kan have øget eksponering for trimetazidin på grund af aldersrelateret nedsat nyrefunktion (se pkt.
English: In the overall population, including both asymptomatic and symptomatic patients, trimetazidine failed to demonstrate a benefit on both ergometric (total exercise duration, time to onset of 1mm ST and time to onset angina) and clinical endpoints.
Danish: I den samlede population, som inkluderede både asymptomatiske og symptomatiske patienter, kunne der ikke påvises fordel ved trimetazidin for hverken ergometriske (samlet varighed af funktionstest, tid til optræden af 1 mm ST og tid til angina pectoris-symptomer) eller kliniske endepunkter.
English: Rash, pruritus, urticaria.
Danish: Udslæt, pruritus, urticaria
English: Palpitations, extrasystoles, tachycardia
Danish: Palpitationer, ekstrasystoler, takykardi
English: Arterial Hypotension , Orthostatic hypotension that may be associated with malaise, dizziness or fall, in particular in patients taking antihypertensive treatment, flushing
Danish: Arteriel hypotension, ortostatisk hypotension, der kan være forbundet med utilpashed, svimmelhed eller fald, især hos patienter, som tager antihypertensiva, ansigtsrødme
English: Dose titration in elderly patients should be exercised with caution (see section 4.4).
Danish: Dosistitrering hos ældre patienter skal gennemføres med forsigtighed (se pkt.
English: How to take <invented name>
Danish: Sådan skal De tage <(Sær)navn>
English: Rare
Danish: Sjældne
English: In patients with ischaemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels.
Danish: Hos patienter med iskæmisk hjertesygdom virker trimetazidin som et metabolisk middel, som bevarer højenergi fosfatniveauer intracellulært i myokardiet.
English: Dizziness, headache
Danish: Svimmelhed, hovedpine
English: Abdominal pain, diarrhoea, dyspepsia, nausea and vomiting
Danish: Abdominalsmerter, diarré, dyspepsi, kvalme og opkastning
English: Clinical studies have demonstrated the efficacy and safety of trimetazidine in the treatment of patients with chronic angina, either alone or when the benefit from other antianginal medicinal products was insufficient.
Danish: Kliniske studier har påvist trimetazidins virkning og sikkerhed til behandling af patienter med kronisk angina pectoris, enten alene, eller hvis virkningen af et andet lægemiddel til behandling af angina pectoris var utilstrækkelig.
English: General disorders and administration conditions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: [the wording below should be inserted in the relevant sections]
Danish: B. Indlægsseddel [følgende tekst indsættes i de relevante afsnit]
English: The dose is one tablet of 35mg of trimetazidine twice daily during meals.
Danish: Dosis er én 35 mg tablet trimetazidin to gange dagligt i forbindelse med et måltid.
English: The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine.
Danish: Forekomsten af motoriske forstyrrelser som f.eks. parkinson-symptomer, restless legs, tremor og ustabil gang skal føre til permanent seponering af trimetazidin.
English: A. Summary of Products Characteristics
Danish: A. Produktresumé
English: Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment (see section 4.8).
Danish: Der kan forekomme fald som følge af ustabil gang eller hypotension, især hos patienter, som tager antihypertensiva (se pkt.
English: However, in the subgroup of symptomatic patients (n= 1574) defined in a post-hoc analysis, trimetazidine (140 mg) significantly improved total exercise duration (+23.8 s versus +13.1 s placebo; p=0.001) and time to onset of angina (+46.3 s versus +32.5 s placebo; p=0.005).
Danish: Hos undergruppen af symptomatiske patienter (n = 1.574) defineret i en post-hoc analyse forbedrede trimetazidin (140 mg) imidlertid den samlede varighed af funktionstest (+ 23,8 s versus + 13,1 s for placebo; p = 0,001) og tiden indtil angina-symptomer (+ 46,3 s versus + 32,5 s for placebo; p = 0,005) signifikant.
English: In a 426-patients randomized, double blind, placebo-controlled study (TRIMPOL-II), trimetazidine (60mg/day) added to metoprolol 100mg daily (50 mg b.i.d) for 12 weeks significantly improved statistically exercise tests parameters and clinical symptoms as compared to placebo: total exercise duration +20.1s, p= 0.023, total workload +0.54 METs, p=0.001, time to 1-mm ST-segment depression +33.4s, p=0.003, time to onset of angina +33.9s, p<0.001, angina attacks/week -0.73, p=0.014 and short acting nitrates consumption/week, -0.63, p=0.032, without hemodynamic changes.
Danish: I et randomiseret, dobbeltblindt, placebokontrolleret studie med 426 patienter (TRIMPOL-II) forbedrede trimetazidin (60 mg/dag) som tillæg til metoprolol 100 mg/dag (50 mg to gange dagligt) i 12 uger statistisk signifikant resultaterne af funktionstest og kliniske symptomer sammenlignet med placebo: Samlet varighed af funktionstest + 20,1 s; p = 0,023; belastning i alt + 0,54 METs; p = 0,001; tid til 1-mm ST-segmentdepression + 33,4 s; p = 0,003; tid til angina pectoris-symptomer + 33,9 s; p < 0,001; angina-anfald/uge - 0,73; p = 0,014 og forbrug af hurtigt virkende nitrater/uge, - 0,63; p = 0,032.
English: Trimetazidine does not have haemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience (see section 4.8), which may affect ability to drive and use machines.
Danish: Trimetazidin har ikke vist hæmodynamiske virkninger i kliniske studier, men efter markedsføringen er der observeret svimmelhed og sløvhed (se pkt.
English: [the wording below should be inserted]
Danish: [følgende tekst indsættes]
English: 4.8 Undesirable effects [the wording below should be inserted]
Danish: 4.8 Bivirkninger [følgende tekst indsættes]
English: Sleep disorders (difficulty in sleeping, drowsiness), constipation, serious generalised red skin rash with blistering, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
Danish: Søvnforstyrrelser (søvnbesvær, døsighed), forstoppelse, alvorligt, rødt hududslæt over hele kroppen med blisterdannelse og hævelse i ansigt, læber, mund, tunge eller svælg/hals, hvilket kan give vejrtræknings- eller synkebesvær.
English: The dose is one tablet of 20mg or 1 ml (20 drops) of oral drop solution of trimetazidine three times a day during meals.
Danish: Dosis er én tablet med 20 mg eller 1 ml (20 dråber) orale dråber trimetazidin tre gange dagligt i forbindelse med et måltid.
English: Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
Danish: 4.1 Terapeutiske indikationer [de aktuelt godkendte indikationer slettes og erstattes af følgende] Trimetazidin er indiceret som tillæg til symptomatisk behandling af stabil angina pectoris hos voksne, som ikke kan kontrolleres tilfredsstillende med eller er intolerante over for førstevalgsbehandling af angina pectoris.
English: A liver disease (nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine).
Danish: Leversygdom (kvalme, opkastning, nedsat appetit, generel utilpashed, feber, kløe, gulfarvning af hud og øjne, lys afføring, mørk urin).
English: Parkinsonian symptoms (tremor, akinesia, hypertonia), gait instability, restlessleg syndrome, other related movement disorders, usually reversible after treatment discontinuation
Danish: Parkinson-symptomer (tremor, akinesi, hypertoni), ustabil gang, restless legs og andre beslægtede motoriske forstyrrelser, almindeligvis reversible efter seponering af behandlingen
English: Talk to your doctor or pharmacist before taking <invented name>
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteket, før De tager <(Sær)navn>.
English: This medicine can cause or worsen symptoms such as trembling, rigid posture, slow movements and a shuffling, unbalanced walk, especially in elderly patients, which should be investigated and reported to your doctor who could reassess the treatment.
Danish: Dette lægemiddel kan forårsage eller forværre symptomer som f.eks. rysten, stive muskler, langsomme bevægelser samt slæbende og ustabil gang, især hos ældre patienter.
English: What you need to know before you take <invented name> Do not take <invented name> - if you are allergic to trimetazidine or any of the other ingredients of this medicine (listed in section - if you have a Parkinson disease: disease of the brain affecting movement (trembling, rigid posture,
Danish: Tag ikke <(Sær)navn>: - hvis De er allergisk over for trimetazidin eller et af de øvrige indholdsstoffer i <(Sær)navn>
English: The recommended dose of <invented name> 35mg is one tablet to be taken two times a day during meals in the morning and evening.
Danish: Den anbefalede dosis af <(Sær)navn> 35 mg er én tablet, der tages to gange dagligt om morgenen og aftenen i forbindelse med et måltid.
English: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 20mg or 1 ml (20 drops) of oral drop solution twice daily, i.e., one in the morning and one in the evening during meals.
Danish: Den anbefalede dosis til patienter med moderat nedsat nyrefunktion (kreatininclearance [30-60] ml/min) er 1 tablet med 20 mg eller 1 ml (20 dråber) orale dråber to gange dagligt, dvs. én om morgenen og én om aftenen i forbindelse med måltider.
English: In a 1962 patients three-month randomised, double-blinded study (Vasco study) on top of atenolol 50 mg/d, two dosages of trimetazidine (70 mg/d and 140 mg/d) were tested versus placebo.
Danish: I et tremåneders randomiseret, dobbeltblindet studie med 1.962 patienter (Vasco-studiet) blev to doser trimetazidin (70 mg/dag og 140 mg/dag) som tillæg til den eksisterende dosis på 50 mg atenolol dagligt sammenlignet med placebo.
English: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg in the morning during breakfast.
Danish: Den anbefalede dosis til patienter med moderat nedsat nyrefunktion (kreatininclearance [30-60] ml/min) er én 35 mg tablet om morgenen i forbindelse med morgenmaden.
English: Dizziness, headache, abdominal pain, diarrhoea, indigestion, feeling sick, vomiting, rash, itching, hives and feeling of weakness.
Danish: Svimmelhed, hovedpine, mavesmerter, diarré, fordøjelsesbesvær, kvalme, opkastning, udslæt, kløe, nældefeber og svækkelse.
English: Constipation
Danish: Obstipation
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller på apoteket.
English: Fast or irregular heartbeats (also called palpitations), extra heartbeats, faster heartbeat, fall in blood pressure on standing-up which causes dizziness, light headiness or fainting, malaise (generally feeling unwell), dizziness, fall, flushing.
Danish: Hjertebanken (kaldes også palpitationer), ekstra hjerteslag, hurtig puls, svimmelhed eller besvimelse ved skift fra liggende til siddende eller fra siddende til stående stilling pga. lavt blodtryk, utilpashed, svimmelhed, faldtendens, ansigtsrødme.
English: Extrapyramidal symptoms (unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs), usually reversible after treatment discontinuation.
Danish: Ekstrapyramidale symptomer (unormale bevægelser, der inkluderer rysten af hænder og fingre, ufrivillige ryk eller trækninger af kroppen, slæbende gang og stivhed i arme og ben).
English: The recommended dose of <invented name> 20mg/ml solution is 20 drops to be taken three times a day during meals.
Danish: Den anbefalede dosis af <(Sær)navn> 20 mg/ml er 20 dråber, der tages tre gange dagligt i forbindelse med et måltid.
English: The recommended dose of <invented name> 20mg is one tablet to be taken three times a day during meals.
Danish: Den anbefalede dosis af <(Sær)navn> 20 mg er én tablet, der tages tre gange dagligt i forbindelse med et måltid.
English: Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected: - moderate renal impairment (see sections 4.2 and 5.2), - elderly patients older than 75 years old (see section 4.2)
Danish: 4.2 og 5.2), ældre patienter over 75 år (se pkt.
English: - Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders, - Severe renal impairment (creatinine clearance < 30ml/min).
Danish: - Parkinsons sygdom, parkinson-symptomer, tremor, restless legs og andre beslægtede motoriske forstyrrelser.
English: What <invented name>is and what it is used for This medicine is intended for use in adult patient, in combination with other medicines to treat angina pectoris (chest pain caused by coronary disease).
Danish: Dette lægemiddel er beregnet til behandling af angina pectoris (smerter i brystet, der skyldes for lidt ilt til hjertemusklen) hos voksne i kombination med andre lægemidler.
English: This includes any side effects not listed in this leaflet.
Danish: Tal med lægen eller apotekspersonalet, hvis De får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: slow movements and a shuffling, unbalanced walk), - if you have severe kidney problems.
Danish: stive muskler, langsomme bevægelser og slæbende gang, ustabil gang).
English: added to 50 mg atenolol (o.d.) for 8 weeks produced a significant increase (+34.4s, p=0.03) in the time to 1-mm ST-segment depression in exercise tests, in a subgroup of patients (n=173), when compared to placebo, 12 hours after taking the drug.
Danish: I et randomiseret, dobbeltblindt, placebokontrolleret studie af 8 ugers varighed med 223 patienter (Sellier) gav én tablet med modificeret udløsning med 35 mg trimetazidin (to gange dagligt) som tillæg til 50 mg atenolol (én gang dagligt) 12 timer efter indtagelse af lægemidlet en signifikant stigning (+ 34,4 s; p = 0,03) i tiden til 1-mm ST-segmentdepression i funktionstest hos en undergruppe af patienter (n = 173) sammenlignet med placebo.
English: Asthenia
Danish: Hjerte
English: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) (see sections 4.4 and 5.2), the recommended dose is 1 tablet of 20mg or 1 ml (20 drops) of oral drop solution twice daily, i.e., one in the morning and one in the evening during meals.
Danish: 4.4 og 5.2) er 1 tablet med 20 mg eller 1 ml (20 dråber) orale dråber to gange dagligt, dvs. om morgenen og om aftenen i forbindelse med et måltid.
English: Cardiac disorders
Danish: Mave-tarm-kanalen
English: These warnings are appropriate.
Danish: Disse advarsler er hensigtsmæssige.
English: Member State EU/EEA
Danish: Medlemsstat EU/EEA
English: The concerned Member States involved are Germany and the Netherlands.
Danish: De berørte medlemsstater er Tyskland og Nederlandene.
English: Direct therapeutic benefit
Danish: Direkte terapeutisk fordel
English: The reference Member State is the United Kingdom.
Danish: Referencemedlemsstaten er Det Forenede Kongerige.
English: Northern Ireland
Danish: Nord Irland
English: 4.5 Special precautions for use iii.
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen iii.
English: Assessment of the data submitted
Danish: Vurdering af de forelagte data
English: Add the following text in the relevant sections of the product information:
Danish: Tilføj følgende tekst i de relevante dele af produktinformationen:
English: No additional studies were carried out in order to further refine the risk as guidance in this area is not currently available.
Danish: Der blev ikke udført supplerende undersøgelser til nærmere bestemmelse af risikoen, da der på nuværende tidspunkt ikke foreligger en vejledning på dette område.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany.
Danish: Efter gennemgang af de forelagte oplysninger konkluderede udvalget følgende vedrørende de spørgsmål, der var rejst i anmeldelsen fra Tyskland:
English: It provided all the information required to be able to make a conclusion on the environmental risk presented by the use of this product.
Danish: Den indeholdt alle de oplysninger, der var nødvendige for, at der kunne drages en konklusion om miljørisikoen ved brug af produktet.
English: Name
Danish: Navn
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU for use in cattle.
Danish: Det aktive stof er velkendt og findes i veterinærlægemidler, der aktuelt er godkendt i EU til kvæg.