FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was the proportion of the patients who were still responding to treatment after 26 weeks.
Danish: Den vigtigste målestok for virkningen var andelen af patienter, som stadig reagerede på behandlingen efter 26 uger.
English: What was CIMZIA expected to be used for?
Danish: Hvad forventedes CIMZIA anvendt til?
English: The Committee was also concerned over CIMZIA's safety: although generally comparable with the safety of other medicines in the same class, there was also some concern over a possible increased risk of bleeding in patients receiving CIMZIA.
Danish: Udvalget havde også betænkeligheder med hensyn til CIMZIA's sikkerhed: selvom den generelt er sammenlignelig med sikkerheden ved andre lægemidler i samme klasse, var der også en vis betænkelighed ved en mulig forøget risiko for blødning hos patienter, som fik CIMZIA.
English: International non-proprietary name (INN): certolizumab pegol
Danish: Internationalt fællesnavn (INN): certolizumab pegol
English: The first study looked at the reduction of symptoms during ‘induction treatment' in 660 patients who had not received CIMZIA before.
Danish: I den første undersøgelse så man nærmere på nedsættelsen af symptomerne under ‘induktionsbehandling' af 660 patienter, som ikke tidligere havde fået CIMZIA.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of CIMZIA in the treatment of severe, active Crohn's disease did not outweigh its risks.
Danish: Derfor var CHMP på daværende tidspunkt af den opfattelse, at fordelene ved CIMZIA til behandling af svær aktiv Crohns sygdom ikke opvejede risiciene herved.
English: The effectiveness of adding CIMZIA to existing treatment was compared with that of placebo (a dummy treatment) in two main studies involving adults with moderate to severe Crohn's disease.
Danish: Effekten af at tilføje CIMZIA til den eksisterende behandling blev sammenlignet med effekten af placebo (en uvirksom behandling) i to hovedundersøgelser, som omfattede voksne med moderat til svær Crohns sygdom.
English: This messenger is involved in causing inflammation and is found at high levels in patients with active Crohn's disease.
Danish: Dette signalstof medvirker til at forårsage inflammation, og det findes i store mængder hos patienter med aktiv Crohns sygdom.
English: The second study looked at the maintenance of the medicine's effects in 428 patients who had responded to an initial six-week course of CIMZIA.
Danish: I den anden undersøgelse så man nærmere på fastholdelsen af lægemidlets virkning hos 428 patienter, som havde reageret på et initialt 6-ugers behandlingsforløb med CIMZIA.
English: CIMZIA is a powder and solvent that is made up into a solution for injection under the skin.
Danish: CIMZIA er pulver og solvens, som blandes til en opløsning til injektion under huden.
English: The active substance in CIMZIA, certolizumab pegol, is an immunosuppressant medicine.
Danish: Det aktive stof i CIMZIA, certolizumab pegol, er et immunosuppressivt lægemiddel.
English: How is CIMZIA expected to work?
Danish: Hvordan forventedes CIMZIA at virke?
English: In the study of induction treatment, CIMZIA showed only marginal effectiveness, which was too low to be relevant for patients.
Danish: I undersøgelsen af induktionsbehandling var effekten af CIMZIA kun marginal, og effekten var for beskeden til at være af relevans for patienterne.
English: CIMZIA was expected to be used to treat severe, active Crohn's disease (a disease causing inflammation of the digestive tract).
Danish: CIMZIA forventedes anvendt til behandling af svær aktiv Crohns sygdom (en sygdom, som forårsager inflammation i fordøjelseskanalen).
English: It contains the active substance certolizumab pegol.
Danish: Det indeholder det aktive stof certolizumab pegol.
English: In CIMZIA, certolizumab has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: Certolizumab er i CIMZIA blevet ‘pegyleret' (forbundet med det kemiske stof polyethylenglycol).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with CIMZIA.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser med CIMZIA eller i programmer for anvendelse med særlig udleveringstilladelse.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using CIMZIA?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med CIMZIA eller i programmer for anvendelse af CIMZIA med særlig udleveringstilladelse?
English: Certolizumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Danish: Certolizumab er opbygget, så det bindes til et af kroppens kemiske signalstoffer, der kaldes tumornekrosefaktor-alpha (TNF-alpha).
English: Hence, the CHMP recommended that CIMZIA be refused marketing authorisation.
Danish: CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for CIMZIA.
English: It includes certolizumab, which is part of a monoclonal antibody.
Danish: Det indeholder certolizumab, som er en del af et monoklonalt antistof.
English: The most commonly reported adverse reactions are diarrhoea and headache, both occurring in approximately 1% of patients.
Danish: De hyppigst rapporterede bivirkninger er diaré og hovedpine, som begge forekommer hos ca. 1% af patienterne.
English: If you take CONTROLOC Control for longer periods, this may cause additional risks, such as:
Danish: Hvis du tager Controloc Control i længere perioder, kan det medføre yderligere risici i form af:
English: Date of first authorisation: 12 June 2009 Date of latest renewal: 21 February 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 12. juni 2009 Dato for sidste fornyelse: 21. februar 2014
English: You may need further blood tests.
Danish: Du skal muligvis have taget flere blodprøver.
English: CONTROLOC Control may stop certain other medicines from working properly.
Danish: CONTROLOC Control kan medføre, at andre lægemidler ikke virker ordentligt.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Other side effects include: - Common (may affect up to 1 in 10 people): Benign polyps in the stomach.
Danish: Andre bivirkninger omfatter: - Almindelig (kan påvirke op til 1 ud af 10 personer): Godartede polypper i maven.
English: CONTROLOC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
Danish: CONTROLOC Control 20 mg enterotabletter bør ikke tygges eller knuses, men skal sluges hele med væske før et måltid.
English: Stop taking CONTROLOC Control when you are completely symptom-free.
Danish: Stop med at tage CONTROLOC Control, når du er symptomfri.
English: Remember to also mention any other ill-effects like pain in your joints.
Danish: Husk også at nævne andre negative virkninger så som ledsmerter.
English: To avoid this interference, CONTROLOC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Danish: For at undgå denne interferens bør CONTROLOC Control seponeres mindst 5 dage inden måling af CgA (se pkt.
English: CONTROLOC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
Danish: CONTROLOC Control må ikke bruges af børn og unge under 18 år pga. manglende dokumentation for sikkerhed i denne aldersgruppe.
English: - fracture of your hip, wrist or spine, especially if you already suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Danish: - Fraktur af hofte, håndled eller rygsøjle, især hvis du allerede lider af osteoporose, eller hvis du tager kortikosteroider (som kan øge risikoen for osteoporose).
English: CONTROLOC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Danish: CONTROLOC Control bør ikke anvendes til børn og unge under 18 år på grund af utilstrækkelige data vedrørende sikkerhed og virkning.
English: CONTROLOC Control has no or negligible influence on the ability to drive and use machines.
Danish: CONTROLOC Control påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your CONTROLOC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Danish: - methotrexat (bruges til behandling af reumatoid artrit, psoriasis og cancer)-hvis du tager methotrexat, kan din læge midlertidigt stoppe din behandling med CONTROLOC Control, da CONTROLOC Control kan forøge niveauet af methotrexat i blodet.
English: - reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low body stores of Vitamin B12.
Danish: - Reduceret optagelse af vitamin B12 og vitamin B12-mangel, hvis dine vitamin B12-depoter i kroppen allerede er lave.
English: This leaflet was last revised in {mm/yyyy}
Danish: Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ}
English: If possible take your medicine and this leaflet with you
Danish: Tag om muligt din medicin og denne indlægsseddel med.
English: Within the following table, adverse reactions are ranked under the MedDRA frequency classification:
Danish: I nedenstående tabel er bivirkningerne ordnet efter MedDRA frekvensklassifikation:
English: CONTROLOC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Danish: CONTROLOC Control findes i aluminim/aluminium-blister med eller uden kartonforstærkning.
English: If you take more CONTROLOC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Danish: Hvis du har taget for meget CONTROLOC Control Fortæl det til lægen eller apoteket hvis du har taget mere end den anbefalede dosis.
English: CONTROLOC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Danish: CONTROLOC Control indeholder det aktive stof pantoprazol, som blokerer den ”pumpe”, der producerer mavesyre.
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping CONTROLOC Control.
Danish: Hvis sådanne hudreaktioner optræder, navnlig på hudområder udsat for sollys, og er ledsaget af arthralgi, bør patienten straks søge læge, og lægen bør overveje at seponere CONTROLOC Control.
English: You must not use CONTROLOC Control if you are taking HIV protease inhibitors.
Danish: Du må ikke tage CONTROLOC Control, hvis du tager HIV-proteasehæmmere.
English: Pharmacotherapeutic group: Drugs for acid related disorders Proton pump inhibitors, ATC code: A02BC02
Danish: Farmakoterapeutisk klassifikation: Protonpumpehæmmere, ATC-kode: A02BC02
English: What CONTROLOC Control contains - The active substance is pantoprazole.
Danish: CONTROLOC Control indeholder: - Aktivt stof: Pantoprazol.
English: Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets
Danish: Aluminium/aluminiumblister, med eller uden kartonforstærkning, der indeholder 7 eller 14 enterotabletter.
English: Do not take CONTROLOC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Danish: Tag ikke CONTROLOC Control samtidigt med anden medicin, som begrænser mængden af syre i din mave, så som andre syrepumpehæmmere (omeprazol, lansoprazol eller rabeprazol) eller en H2-antagonist (f.eks. ranitidin, famotidin).
English: You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with CONTROLOC Control, but this medicine is not meant to bring immediate relief.
Danish: Du kan opleve lindring af dine symptomer på sure opstød og halsbrand efter kun en dags behandling med CONTROLOC Control, men denne medicin har ikke til hensigt at give øjeblikkelig lindring.
English: What you need to know before you take CONTROLOC Control
Danish: Det skal du vide, før du begynder at tage CONTROLOC Control
English: Stevens-Johnson syndrome; Lyell syndrome;
Danish: Stevens-Johnson syndrom, Lyell syndrome, erythema multiforme, lysfølsomhed
English: CONTROLOC Control'.
Danish: Se 'tag ikke CONTROLOC Control '.
English: CONTROLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Danish: CONTROLOC Control kan reducere absorptionen af aktive stoffer, hvis biotilgængelighed er pH-afhængig (fx. ketoconazol).
English: However, you may take CONTROLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Danish: Du må gerne tage CONTROLOC Control samtidig med syreneutraliserende medicin (f.eks. magaldrat, alginsyre, natriumbicarbonat, aluminiumhydroxid, magnesiumcarbonat eller kombinationer heraf), hvis det er nødvendigt.
English: Liver enzymes increased (transaminas es, γ-GT)
Danish: Forhøjede leverenzym er (transamina ser, γ-GT)
English: If you have been suffering from repetitive heartburn or indigestion symptoms for some time, remember to see your doctor regularly.
Danish: Hvis du gennem den seneste tid har lidt af halsbrand-eller fordøjelsesbesværsymptomer, skal du huske at gå til læge regelmæssigt.
English: - if you are due to have a specific blood test (Chromogranin A) - if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of
Danish: - du skal have taget en særlig blodprøve (chromogranin A) - hvis du tager HIV-proteasehæmmere såsom atazanavir; nelfinavir (til behandling af
English: Do not take a double dose to make up for the forgotten dose.
Danish: Hvis du har glemt at tage CONTROLOC Control Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: - Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, concentrated.
Danish: - Blæk til prægning: Shellac; rød, sort og gul jernoxid (E 172); koncentreret ammoniakopløsning.
English: CONTROLOC Control should not be used during breast-feeding.
Danish: CONTROLOC Control bør ikke anvendes under graviditet.
English: Control that reduces stomach acid.
Danish: CONTROLOC Control, der nedsætter syreindholdet i maven.
English: Abdominal distension and bloating; Constipation ; Dry mouth; Abdominal pain and discomfort
Danish: Diaré kvalme/ opkastning, udspilet abdomen og oppustethed, forstoppelse, tørhed i munden, abdominale smerter og ubehag
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Danish: Fortæl det straks til lægen før eller efter du har taget medicinen, hvis du oplever nogle af følgende symptomer, som kan være et tegn på en anden, mere alvorlig, sygdom: - uventet vægttab (som ikke er relateret til diæt eller et motionsprogram) - opkastning, især ved gentagelse - blodigt opkast, dette kan ses som mørkt kaffegrums i dit opkast - du opdager blodig afføring, som kan være sort eller tjærefarvet - synkebesvær eller smerte i forbindelse med synkning - du ser bleg ud eller føler dig sløj (blodmangel) - brystsmerter - mavesmerter - kraftig og/eller vedvarende diaré, da dette lægemiddel er forbundet med en let øget risiko for infektiøs diaré - hvis du får udslæt, især på de dele af huden, der er udsat for sol, skal du snarest sige det til lægen, da du kan være nødt til at holde op med at tage CONTROLOC Control.
English: Depression (and all aggravations)
Danish: Depression (og forværring af allerede eksisterende symptomer)
English: What CONTROLOC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Danish: Enterotabletterne er gule, ovale, bikonvekse filmovertrukne tabletter præget med ”P20” på den ene side.
English: Fundic gland polyps (benign)
Danish: Polypper på fundus (godartede)
English: Do not take CONTROLOC Control tablets for more than 4 weeks without consulting your doctor.
Danish: Tag ikke CONTROLOC Control -tabletter i mere end 4 uger uden at kontakte lægen.
English: How to take CONTROLOC Control
Danish: Sådan skal du tage CONTROLOC Control
English: CONTROLOC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Danish: CONTROLOC Control bruges til korttidsbehandling af reflukssymptomer (f.eks. halsbrand og sure opstød) hos voksne.
English: Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg Germany
Danish: Production site Oranienburg Lehnitzstraße 70-98
English: - Uncommon side effects (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test; fracture in the hip, wrist or spine.
Danish: - Ikke almindelige bivirkninger ( kan påvirke mellem 1 og 100 personer): Hovedpine; svimmelhed; diaré; kvalme, opkastning; oppustethed og luftafgang fra tarmen; forstoppelse; mundtørhed; smerter og ubehag i maven; hududslæt og eksem; kløe; svaghedsfornemmelse, udmattet eller generelt utilpas; søvnforstyrrelser; forøgede leverenzymtal ved blodprøve; fraktur i hofte, håndled eller rygsøjle.
English: CONTROLOC Control 20 mg gastro-resistant tablets Pantoprazole
Danish: CONTROLOC Control 20 mg enterotabletter Pantoprazol
English: - Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood, rash, possibly with pain in the joints; feeling of tingling, prickling, pins and needles, burning sensation or numbness, inflammation in the large bowel, that causes persistent watery diarrhoea.
Danish: Hallucinationer, forvirring (specielt hos patienter som i forvejen har haft disse symptomer); nedsat natrium; magnesium i blodet, udslæt, eventuelt med ledsmerter, en stikkende, prikkende, snurrende eller brændende fornemmelse eller følelsesløshed, tyktarmsbetændelse, der giver vedvarende, vandig diarré.
English: Hepatocellular injury; Jaundice; Hepatocellular failure
Danish: Hepatocellulær skade, gulsot, leversvigt
English: Rash / exanthema / eruption;
Danish: Udslæt/eksa ntem/ eruptioner, Kløe
English: - Rare side effects: distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities; depression; increased bilirubin and fat levels in blood (seen in blood tests), breast enlargement in males; high fever and a sharp drop in circulating granular white blood cells (seen in blood tests).
Danish: - Sjældne bivirkninger (kan påvirke mellem 1 ud af 10.000 personer): Smagsforstyrrelser eller fuldstændig mangel på smagsans; synsforstyrrelser så som sløret syn; ledsmerter; muskelsmerter; ændringer i kropsvægt; forhøjet kropstemperatur; hævede hænder og fødder; allergiske reaktioner; depression; forhøjede værdier af bilirubin og fedt i blodet (kan ses i blodprøver); forstørrelse af brystkirtlerne hos mænd; høj feber og kraftigt fald i antallet af hvide blodceller (i blodprøver).
English: What CONTROLOC Control is and what it is used for What you need to know before you take CONTROLOC Control How to take CONTROLOC Control Possible side effects
Danish: Det skal du vide, før du begynder at tage CONTROLOC Control Sådan skal du tage CONTROLOC Control Bivirkninger
English: CONTROLOC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Danish: CONTROLOC Control er indiceret til korttidsbehandling af reflukssymptomer (fx halsbrand, syreregurgitation) hos voksne.
English: HIV-infection) See ‘Other medicines and CONTROLOC Control'.
Danish: Se brug af andet medicin sammen med CONTROLOC Control.
English: Tabulated list of adverse reactions The following adverse reactions have been reported with pantoprazole.
Danish: Følgende bivirkninger er blevet rapporteret ved brug af pantoprazol.
English: Do not take CONTROLOC Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of
Danish: Tag ikke CONTROLOC Control: - hvis du er allergisk over for pantoprazol eller et af de øvrige indholdsstoffer (angivet i afsnit 6
English: Agranulocytosis Thrombocytopenia ; Leukopenia,
Danish: Trombocytopeni, leukopeni, pancytopeni
English: - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test. - if you have ever had a skin reaction after treatment with a medicine similar to CONTROLOC
Danish: - hvis du tidligere har haft et mavesår eller har fået foretaget en maveoperation - hvis du har leverproblemer eller gulsot (gulfarvning af huden og øjnene) - hvis du regelmæssigt tager til læge på grund af alvorlige sygdomme eller lidelser - hvis du skal have fortaget en endoskopi eller en udåndingstest kaldet C-urea.
English: However adverse reactions such as dizziness and visual disturbances may occur (see section 4.8).
Danish: Ved brug af Pantoprazol kan bivirkninger som svimmelhed og synsforstyrrelser forekomme (se pkt.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med CONTROLOC Control Fortæl det til lægen eller apoteket, hvis du tager, har taget eller overvejer at tage andet medicin.
English: Body temperature increased;
Danish: Forhøjet kropstemperat ur, perifert ødem
English: CONTROLOC Control 20 mg gastro-resistant tablets
Danish: CONTROLOC Control 20 mg, enterotabletter
English: Red iron oxide (E172) Black iron oxide (E172) Yellow iron oxide (E172) Ammonia solution, concentrated
Danish: Rød jernoxid (E 172) Sort jernoxid (E 172) Gul jernoxid (E 172)
English: Pancytopenia
Danish: Agranulocytose
English: Takeda GmbH, Podružnica Slovenija Tel: + 386 (0) 59082480
Danish: Tel: + 386 (0) 59082480
English: Pregnancy and, breast-feeding
Danish: Graviditet og amning