FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of hyponatraemia is greater in women, patients with hypokalaemia or low sodium/solute intake, and in the elderly.
Danish: Risikoen for hyponatriæmi er større hos kvinder, hos patienter med hypokaliæmi eller lavt natrium/væskeindtag samt hos ældre.
English: Dysgeusia, cerebral ischaemia, transient ischaemic attack, ischaemic stroke, peripheral neuropathy Cardiac disorders
Danish: Dysgeusi, cerebral iskæmi, transitorisk cerebral iskæmi, iskæmisk apopleksi, perifer neuropati Hjerte
English: Patients with liver cirrhosis
Danish: Patienter med levercirrose
English: The risk of hyponatraemia is greater in women, patients with hypokalaemia or low sodium/solute intake, and the elderly.
Danish: Risikoen for hyponatriæmi er større hos kvinder, patienter med hypokaliæmi eller lavt natrium/væskeindtag samt hos ældre.
English: Cilazapril belongs to a group of medicines called ‘ACE inhibitors' (Angiotensin Converting Enzyme Inhibitors).
Danish: Cilazapril tilhører en gruppe lægemidler kaldet ACE-hæmmere (angiotensinkonverterende enzymhæmmere).
English: The signs include bruising easily and nose bleeds.
Danish: Symptomerne omfatter tendens til blå mærker og næseblod.
English: Hypokalaemia may also occur in patients receiving Vascace Plus, although to a lesser extent than that seen in patients receiving thiazide monotherapy.
Danish: Hypokaliæmi kan også forekomme hos patienter som får Vascace Plus, om end i mindre grad end set hos patienter, som får thiazidmonoterapi.
English: Check with your doctor or pharmacist before taking Vascace Plus - if you have a heart problem.
Danish: Vær ekstra forsigtig med at tage Vascace Plus Tal med din læge eller apoteket, inden du tager Vascace Plus - hvis du har et hjerteproblem.
English: Treatment-related adverse events resulting in treatment withdrawal occur in less than 5% of patients receiving ACE inhibitor monotherapy.
Danish: Behandlingsrelaterede bivirkninger, der resulterer i seponering af behandlingen, forekommer hos færre end 5 % af de patienter, som får ACEhæmmer som monoterapi.
English: When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Danish: Når graviditet konstateres, skal behandling med ACE-hæmmer straks stoppes, og hvis det er relevant, skal anden behandling igangsættes (se pkt.
English: In patients with ascites, cilazapril is not recommended.
Danish: Cilazapril anbefales ikke til patienter med ascites.
English: Dry mouth, aphthous stomatitis, decreased appetite, diarrhoea, vomiting, glossitis, pancreatitis Hepatobiliary disorders
Danish: Mundtørhed, aftøs stomatit, nedsat appetit, diarré, opkastning, glossitis, pancreatitis
English: Dyspnoea, bronchospasm, rhinitis, interstitial lung disease, bronchitis, sinusitis Gastrointestinal disorders
Danish: Dyspnø, bronkospasmer, rinitis , interstitiel lungesygdom, bronkitis, sinusitis Mave-tarmkanalen
English: Anaphylactic reactions can occur in patients undergoing desensitization therapy with wasp or bee venom while receiving an ACE inhibitor.
Danish: Anafylaktiske reaktioner kan opstå hos patienter, som gennemgår desensibiliseringsbehandling med hvepse- eller bigift, mens de er i behandling med en ACE-hæmmer.
English: Owing to the presence of lactose monohydrate, patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: På grund af indhold af lactosemonohydrat bør Vascace Plus ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp Lactase deficiency) eller glucosegalactosemalabsorption.
English: The following effects may happen: feeling dizzy or light-headed, shallow breathing, cold clammy skin, being unable to move or speak and a slow or irregular heart beat.
Danish: Tag pakningen med. Følgende bivirkninger kan forekomme: Svimmelhed, overfladisk vejrtrækning, kold og klam hud, at være ude af stand til at bevæge sig eller tale eller langsopuls.
English: The signs include feeling tired, pale skin, fast or uneven heart beat (palpitations), and feeling short of breath.
Danish: Symptomerne omfatter træthed, bleghed, hurtige eller uregelmæssige hjerteslag (hjertebanken) og stakåndethed.
English: This is because Vascace Plus can affect the way some medicines work.
Danish: Grunden er, at Vascace Plus kan påvirke behandlingen med anden medicin, og anden medicin kan påvirke behandlingen med Vascace Plus.
English: Abnormal liver function test (including transaminases, bilirubin, alkaline phosphatase, gamma GT), cholestatic hepatitis with or without necrosis
Danish: Unormale leverfunktionstest (herunder aminotransferaser, bilirubin, basisk fosfatase, gammaglutamyltransferase (gamma-GT)), kolestatisk hepatitis med eller uden nekrose Hud og subkutane væv
English: Renal impairment and acute renal failure are more likely in patients with severe heart failure, renal artery stenosis, pre-existing renal disorders or volume depletion (see section 4.4).
Danish: Der er større risiko for nedsat nyrefunktion og akut nyreinsufficiens hos patienter med alvorlig hjerteinsufficiens, nyrearteriestenose, præeksisterende nyresygdomme eller volumendepletion (se pkt.
English: Thrombocytopaenia, haemolytic anaemia, bone marrow failure, neutropenia Immune system disorders
Danish: Trombocytopeni, hæmolytisk anæmi, knoglemarvsdepression, neutropeni Immunsystemet
English: Hypokalaemia may occur in patients receiving Vascace Plus, although less commonly than in patients receiving thiazide monotherapy.
Danish: Hypokaliæmi kan forekomme hos patienter, som får Vascace Plus, men sjældnere end hos patienter, som får thiazid-monoterapi.
English: Sexual dysfunction, gynaecomastia
Danish: Seksuel dysfunktion, gynækomasti
English: Uncommon (affects less than 1 in 100 people)
Danish: Ikke almindelige (forekommer hos færre end 1 ud af 100 behandlede) - Lavt blodtryk.
English: Nervous system disorders
Danish: Søvnforstyrrelser, depression Nervesystemet
English: - Gold compounds (used to treat rheumatoid arthritis).
Danish: - Guldforbindelser (bruges til behandling af leddegigt).
English: The most frequent drug-attributable adverse events observed in patients receiving ACE inhibitor monotherapy are cough, skin rash and renal dysfunction.
Danish: De hyppigste lægemiddelrelaterede bivirkninger, som er observeret hos patienter, som får ACEhæmmer som monoterapi, er hoste, udslæt og påvirkning af nyrefunktionen.
English: Cilazapril is converted to its active metabolite, cilazaprilat, a specific long-acting angiotensinconverting enzyme (ACE) inhibitor which suppresses the renin-angiotensin-aldosterone system and thereby the conversion of the inactive angiotensin I to angiotensin II, which is a potent vasoconstrictor.
Danish: ACE-hæmmere undertrykker renin-angiotensin-aldosteronsystemet og således konverteringen af det inaktive angiotensin I til angiotensin II, som er en potent vasokonstriktor.
English: Confusional state
Danish: Forvirringstilstand
English: Hence, Vascace Plus should be used with caution in patients with a history of gout.
Danish: Vascace Plus bør derfor anvendes med forsigtighed hos patienter med arthritis urica i anamnesen.
English: Rash, photosensitivity, pseudoporphyria, cutaneous vasculitis Musculoskeletal and connective tissue disorders Uncommon
Danish: Udslæt, lysfølsomhed, pseudoporfyri, kutan vasculitis Knogler, led, muskler og bindevæv Ikke almindelig
English: Hydrochlorothiazide binds to 65% to plasma proteins; the relative volume of distribution has been determined to be 0.5 to 1.1 l/kg.
Danish: Den relative distributionsvolumen er blevet bestemt til 0,5-1,1 l/kg.
English: Cholestatic jaundice
Danish: Kolestatisk gulsot
English: - Medicines to treat heart failure or heart rhythm abnormalities.
Danish: - Medicin som bruges til at behandle hjertesvigt eller forstyrrelser i hjerterytmen.
English: indometacin and ibuprofen.
Danish: Disse inkluderer acetylsalicylsyre, indometacin og ibuprofen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt] LISTE OVER HJÆLPESTOFFER [Udfyldes nationalt]
English: Interstitial pneumonitis, acute pulmonary oedema Gastrointestinal disorders
Danish: Interstitiel pneumoni, akut lungeødem Mave-tarmkanalen
English: Renal impairment, acute renal failure (see section 4.4), blood creatinine increased, blood urea increased, hyperkalaemia, hyponatraemia, proteinuria, nephrotic syndrome, nephritis Reproductive system and breast disorders
Danish: 4.4), forhøjet serum-kreatinin, forhøjet serumcarbamid, hyperkaliæmi, hyponatriæmi, proteinuri, nefrotisk syndrom, nefritis Det reproduktive system og mammae
English: Anaphylaxis has occurred in patients dialysed with high flux membranes (e.g. AN 69) receiving ACE inhibitors.
Danish: Anafylaksi er forekommet hos patienter i dialyse med high flux-membraner (f.eks.
English: Thiazides may increase serum uric acid levels and may precipitate acute gout.
Danish: Thiazider kan øge serum-urinsyre og fremprovokere akut arthritis urica.
English: Detailed information on this medicinal product is available on the website of {name of MS/Agency}
Danish: Yderligere information om dette lægemiddel er tilgængelig på Lægemiddelstyrelsen hjemmeside www.laegemiddelstyrelsen.dk.
English: - Cerebral ischaemia, transient ischaemic attack, ischaemic stroke (may occur if blood pressure becomes too low) - Myocardial infarction (may occur if blood pressure becomes too low) - Irregular heartbeat - Interstitial lung disease - A disorder resembling systemic lupus erythematosus - Pins and needles or numbness in the hands or feet - Wheezing - A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis).
Danish: (kan opstå, hvis dit blodtryk bliver for lavt) - Blodprop i hjertet (kan opstå, hvis dit blodtryk bliver for lavt) - Uregelmæssig puls - Interstitiel lungesygdom - En lidelse, der ligner systemisk lupus erythematosus - Stikken og prikken eller følelsesløshed i hænder eller fødder - Hvæsende vejrtækning - Følelse af tilstoppethed eller en pulserende smerte bag næsen, kinderne og øjnene
English: Single cases of liver function disorders, such as increased values of liver function tests (transaminases, bilirubin, alkaline phosphatase, gamma GT) and cholestatic hepatitis with or without necrosis have been reported in patients treated with cilazapril.
Danish: Der er rapporteret enkelte tilfælde af leverfunktionsforstyrrelser hos patienter i behandling med cilazapril, som f.eks. forhøjede leverværdier ved leverfunktionstest (aminotransferaser, bilirubin, basisk fosfatase, gamma-glutamyltransferase (gamma-GT)) og kolestatisk hepatitis med eller uden nekrose.
English: What Vascace Plus is and what it is used for Before you take Vascace Plus How to take Vascace Plus Possible side effects
Danish: Det skal du vide, før du begynder at tage Vascace Plus Sådan skal du tage Vascace Plus Bivirkninger
English: BEFORE YOU TAKE VASCACE PLUS
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE VASCACE PLUS
English: Plasma protein binding is approximately 25 to 30%.
Danish: Plasmaproteinbinding er ca.
English: Because significant hypotension may occur in patients with liver cirrhosis treated with standard doses of ACE inhibitors, cautious dose titration of each individual component is needed if patients with liver cirrhosis should require treatment with cilazapril and hydrochlorothiazide (see section 4.4).
Danish: Forsigtig dosistitrering af hver enkelt komponent er derfor nødvendig, hvis patienter med levercirrose har brug for behandling med cilazapril og hydrochlorthiazid (se pkt.
English: If hypotension occurs, the patient should be placed in the shock position.
Danish: Ved hypotension skal patienten placeres i shockposition (Trendelenburgs Leje).
English: (It is also better to avoid Vascace Plus in early pregnancy - see the sections on “Pregnancy” and “Breastfeeding”.)
Danish: - hvis du er gravid og mere end 3 måneder henne (det er også bedst af undgå Vascace Plus tidligt i graviditeten - se afsnittet ”Graviditet og amning”).
English: Angioedema (may involve the face, lips, tongue, larynx or gastrointestinal tract) (see section 4.4), anaphylaxis (see section 4.4), lupus-like syndrome (symptoms may include vasculitis, myalgia, arthralgia/arthritis, positive antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis)
Danish: 4.4), lupus-lignende syndrom (symptomerne kan omfatte vasculitis, myalgi, artralgi/artritis, positive antinukleære antistoffer, forhøjet blodsænkning, eosinofili og leukocytose) Nervesystemet
English: Dry mouth, sialoadenitis, loss of appetite, pancreatitis Hepatobiliary disorders
Danish: Mundtørhed, sialoadenitis, appetitløshed, pancreatitis Lever og galdeveje
English: Desensitization
Danish: Desensibilisering
English: (anemia, neutropenia, agranulocytosis and thrombocytopenia) - Blood tests showing abnormal electrolyte levels (sodium, potassium, chloride, magnesium,
Danish: - Blodprøver som viser unormale elektrolytniveauer (natrium, kalium, chlorid, magnesium,
English: calcium, bicarbonate), or elevated glucose, urate, cholesterol and triglyceride levels - A type of severe allergic reaction (anaphylaxis)
Danish: calcium, hydrogencarbonat) eller øget indhold af glucose, urat, kolesterol og triglycerid.
English: - Feeling dizzy - Coughing - Nausea - Feeling tired - Headache
Danish: Almindelige (forekommer hos færre end 1 ud af 10 behandlede) - Svimmelhed - Hoste - Kvalme - Træthed - Hovedpine
English: Because no information is available regarding the use of Vascace Plus during breastfeeding, this product is not recommended, and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Andre regimer med en bedre fastslået sikkerhedsprofil under amning er at foretrække, især ved amning af nyfødte og for tidligt fødte spædbørn.
English: Amantidine
Danish: Amning
English: - History of angioedema associated with previous ACE inhibitor therapy - Hereditary or idiopathic angioedema - Renal impairment (creatinine clearance <30 ml/min/1.73 m2) or anuria - Second and third trimesters of pregnancy (see sections 4.4 and 4.6)
Danish: - Nedsat nyrefunktion (kreatininclearance < 30 ml/min/1,73 m2) eller anuri.
English: 6.1 List of excipients [To be completed nationally]
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer [Udfyldes nationalt]
English: Lacrimation decreased, visual impairment, xanthopsia Cardiac disorders
Danish: Øget tåredannelse, synssvækkelse, gulsyn Hjerte
English: What Vascace Plus looks like and contents of the pack [To be completed nationally]
Danish: Udseende og pakningsstørrelser [Udfyldes nationalt]
English: Cilazapril had no effect on male or female fertility in rats.
Danish: Cilazapril har ingen effekt på fertiliteten hos han- og hunrotter.
English: Arrhythmia
Danish: Anafylaksi
English: Clinical/Efficacy Studies
Danish: Kliniske virkning
English: - It does not matter what time of day you take Vascace Plus.
Danish: - Du kan tage Vascace Plus på et hvilket som helst tidspunkt på dagen.
English: Haemodialysis
Danish: Muskelkramper
English: Take special care with Vascace Plus
Danish: - Lægen har ordineret Vascace Plus til dig personligt.
English: - Anaesthetics, narcotics.
Danish: - Hereditært eller idiopatisk angioødem.
English: If you have an intolerance to lactose, talk to your doctor before taking this medicine.
Danish: Tal med lægen, inden du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Dizziness
Danish: Amantadin
English: 3 (3 x 1) pre-filled pens (multipack)
Danish: 3 (3 x 1) fyldte penne (multipakning)
English: 1 ml (140 mg/ml) 3 (3 x 1) pre-filled pens (multipack)
Danish: 1 ml (70 mg/ml) 3 (3 x 1) fyldte penne (multipakning)
English: 1 ml (140 mg/ml) 1 pre-filled pen
Danish: 1 ml (70 mg/ml) 1 fyldt pen
English: 1 ml (140 mg/ml) 1 pre-filled syringe
Danish: 1 ml (70 mg/ml) 1 fyldt injektionssprøjte
English: MA (EU) number (Invented) name Strength
Danish: MF (EU)-nummer Særnavn
English: MA (EU) Number
Danish: MF (EU) -nummer
English: 1 ml (120 mg/ml) 1 pre-filled pen
Danish: 1 fyldt pen
English: 48 months
Danish: 48 måneder.
English: Date of first authorisation: 18 September 2017
Danish: Dato for første markedsføringstilladelse: 18 september 2017
English: No new significant safety signals were identified.
Danish: Der blev ikke identificeret nogen væsentlige nye sikkerhedssignaler.
English: Talk to a doctor.
Danish: Tal med lægen.
English: Some cases had more than one event of intestinal obstruction.
Danish: Nogle tilfælde havde mere end én hændelse med intestinal obstruktion.
English: It will reduce your diarrhoea.
Danish: Det vil reducere din diarré.
English: No specific study has been performed in the elderly population.
Danish: Der er ikke foretaget specifikke studier i en ældre population.
English: • Always take this medicine with a meal or some food.
Danish: • Tag altid lægemidlet sammen med et måltid eller noget mad.
English: They were generally of mild or moderate intensity.
Danish: De var generelt af mild eller moderat intensitet.
English: a. Baseline data based on all patients with data at baseline.
Danish: a. Baseline data baseret på alle patienter med data ved baseline.
English: Monitoring for suboptimal efficacy is recommended.
Danish: Monitorering for suboptimal virkning anbefales.
English: This medicine is not recommended in patients below 18 years old.
Danish: Denne medicin anbefales ikke til patienter under 18 år.
English: Number of patients Responder, n (%)
Danish: Antal patienter Responder, n (%)
English: Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Danish: Tilgængelige data tyder på at klinisk respons oftest opnås inden for 12 ugers behandling.
English: You should not take this medicine if you are pregnant or might become pregnant.
Danish: Du må ikke tage denne medicin, hvis du er gravid eller kan blive gravid.
English: There were 12 patients who were “very satisfied”, and all of them were on telotristat.
Danish: Der var 12 patienter, som var "meget tilfredse", og de var alle på telotristat.
English: Percentage of patients with durable responseb
Danish: Procentdel af patienter med varig responsb
English: A total of 135 patients were evaluated for efficacy.
Danish: I alt 135 patienter blev evalueret for virkning.
English: Relevance of these gastrointestinal findings to humans is unknown.
Danish: Relevansen af disse gastrointestinale fund hos mennesker er ukendt.
English: • octreotide.
Danish: • octreotid.
English: Questions were asked to blinded participants to further characterise the degree of change experienced during the trial.
Danish: Der blev stillet spørgsmål til blindede deltagere for yderligere at karakterisere den grad af forandring, som de oplevede under studiet.
English: These may be signs that your liver is not working properly.
Danish: Dette kan være tegn på, at din lever ikke fungerer godt.
English: This is to check that your liver is working normally.
Danish: Det er for at undersøge, om at din lever fungerer normalt.
English: It is recommended to reassess the benefit of continued therapy in a patient not responding within this time period.
Danish: Det anbefales at revurdere fordelen af at forsætte behandlingen hos en patient, som ikke responderer inden for dette tidsrum.
English: • Your doctor may carry out blood tests before you start taking this medicine and while you are taking it.
Danish: • Lægen kan tage blodprøver før du begynder at tage dette lægemiddel og mens du tager det.
English: The majority of intestinal obstruction events were serious (56 cases) and 33 cases were medically confirmed.
Danish: Størstedelen af tilfældene med intestinale obstruktive hændelser var alvorlige (56 tilfælde), og 33 tilfælde blev medicinsk bekræftet.
English: The majority was eliminated in the faeces.
Danish: Størstedelen blev elimineret i fæces.
English: The blisters are packaged in a carton.
Danish: Blisterpakningerne er pakket i en karton.
English: In a phase 3 study of similar design (TELECAST), a total of 76 patients were evaluated for efficacy.
Danish: I et fase 3 studie af lignende design (TELECAST) blev i alt 76 patienter evalueret for virkning.
English: Management of overdose Treatment of an overdose should include general symptomatic management.
Danish: Håndtering af overdosering Behandling af overdosering bør omfatte generel symptomatisk behandling.
English: This is because the medicine has not been tested in this age group.
Danish: Dette skyldes, at medicinen ikke er blevet testet i denne aldersgruppe.
English: These have not been associated with concomitant elevations in total serum bilirubin.
Danish: Disse har ikke været forbundet med samtidig stigninger i totalt serumbilirubin.
English: Therapy with telotristat should not be resumed unless the liver injury can be explained by another cause.
Danish: Behandling med telotristat bør ikke genoptages medmindre leverskaden kan forklares ved en anden årsag.
English: • if you feel down, depressed, or if you feel you have no interest or take any pleasure in doing your normal activities, whilst taking this medicine
Danish: • hvis du føler dig nedtrykt, deprimeret, eller hvis du føler dig uinteresseret i eller uden glæde i at udføre dine normale aktiviteter, når du tager denne medicin.
English: Your doctor will do blood tests to check your liver and will decide whether you should keep taking this medicine.
Danish: Din læge vil tage blodprøver for at tjekke leveren og beslutte, om du fortsat skal tage denne medicin.
English: It is not known how telotristat may affect the baby.
Danish: Det vides ikke, hvordan telotristat kan påvirke barnet.
English: - if you are allergic to telotristat or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for telotristat eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Although patients with carcinoid syndrome may have a predisposition for depression, there were 38 post-marketing cases indicative of depression and depression-related events including two cases with positive dechallenge.
Danish: Selvom patienter med karcinoid syndrom kan være prædisponeret for depression, var der 38 tilfælde efter markedsføring, som tydede på depression og depressionsrelaterede hændelser, herunder to tilfælde med positiv dechallenge.
English: A cumulative search identified 62 relevant cases some of which with a close temporal relationship with the initiation of treatment with telotristat.
Danish: En kumulativ søgning identificerede 62 relevante tilfælde, hvoraf nogle havde tæt tidsmæssig sammenhæng med initiering af behandlingen med telotristat.
English: The clinical significance of the decrease in brain 5-HIAA with or without a concomitant decrease in brain 5-HT is unknown.
Danish: Den kliniske betydning af faldet i 5-HIAA i hjernen med eller uden samtidig reduktion i 5-HT i hjernen er ukendt.
English: The carcinogenic potential of telotristat etiprate was studied in transgenic mice (26 weeks) and rats (104 weeks).
Danish: Telotristatetiprats karcinogene potentiale blev undersøgt hos transgene mus (26 uger) og rotter (104 uger).
English: LP-951757 was pharmacologically inactive at TPH1 in vitro.
Danish: LP-951757 var farmakologisk inaktiv overfor TPH1 in vitro.
English: Most patients (92.1%) had fewer than 4 BM per day and all except 9 were treated by SSA therapy.
Danish: De fleste patienter (92,1 %) havde færre end 4 afføringer pr. dag, og alle undtagen 9 blev behandlet med SSA-medicin.
English: Women should use effective methods of contraception while taking this medicine.
Danish: Kvinder skal anvende et effektivt præventionsmiddel, mens de tager dette lægemiddel.
English: The increases were largely reversible on dose interruption or reduction, or recovered whilst maintaining treatment at the same dose.
Danish: Stigningerne var stort set reversible ved dosisafbrydelse eller dosisreduktion, eller blev restitueret ved at behandlingen blev holdt ved samme dosis.