FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors.
Danish: Efter markedsføringen er der også rapporteret om perifere ødemer og hjertesvigt hos patienter, der fik samtidig behandling med pioglitazon og non-steroide antiinflammatoriske lægemidler, inklusive selektive COX-2-hæmmere.
English: Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Danish: Inden for hver enkelt systemorganklasse er bivirkningerne opstillet efter, hvor alvorlige de er med de alvorligste bivirkninger anført først.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (98 TABLETS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MELLEMÆSKE (UDEN BLÅ BOKS) KUN TIL MULTIPAKNINGER (98 TABLETTER)
English: The film-coated tablets (tablets) are white to off white, oblong, convex, embossed ‘15 / 850' on one face and ‘4833M' on the other.
Danish: De filmovertrukne tabletter (tabletterne) er hvide til offwhite, aflange og konvekse mærket med ‘15 / 850' på den ene side og ‘4833M' på den anden side.
English: comprising 2 packs, each containing 98 film-coated tablets.
Danish: Indgår i en multipakning med 2 pakninger á 98 filmovertrukne tabletter.
English: Vitamin B12 absorption decreased2
Danish: Metabolisme og ernæring nedsat absorption af B12-vitamin2
English: Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
Danish: Kontakt lægen hurtigst muligt, hvis De får symptomer, som kan tyde på leverproblemer (såsom uforklarlig kvalme, opkastning, mavesmerter, træthed, appetitløshed og/eller mørk urin), da Deres leverfunktion bør tjekkes.
English: Common (may affect up to 1 in 10 people) - localised swelling (oedema) - weight gain - headache - respiratory infection - abnormal vision - joint pain - impotence - blood in urine - reduction in blood count (anaemia) - numbness - taste disturbance
Danish: Almindelige (kan forekomme hos 1 ud af 10 behandlede) - lokale hævelser (ødemer) - vægtstigning - hovedpine - infektion i luftvejene - synsforstyrrelser - ledsmerter - impotens - blod i urinen - blodmangel (anæmi) - følelsesløshed - smagsforstyrrelser
English: Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat
Danish: Symptomerne på laktatacidose omfatter: - opkastning - mavesmerter - muskelkramper - almen utilpashed med udpræget træthed - vejrtrækningsbesvær - nedsat kropstemperatur og langsommere puls
English: - you must tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: - Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De fortælle det til Deres læge.
English: bladder cancer uncommon uncommon
Danish: Blærecancer ikke almindelig
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2 x 98 TABLETS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET (MED BLÅ BOKS) KUN TIL MULTIPAKNINGER (2 x 98 TABLETTER)
English: If a pregnancy occurs, treatment with Competact should be discontinued.
Danish: Hvis en patient bliver gravid, skal behandlingen med Competact seponeres.
English: Competact should be used every day to work properly.
Danish: For at opnå den ønskede virkning skal De tage Competact hver dag.
English: Clinical trials have been conducted with Competact tablets and co-administered pioglitazone and metformin (see section 5.1).
Danish: Der er udført kliniske forsøg med både Competacttabletter og samtidig administration af pioglitazon og metformin (se pkt.
English: When clinically appropriate, direct change from metformin monotherapy to Competact may be considered.
Danish: Et direkte skift fra metformin monoterapi til Competact kan overvejes, hvis det vurderes klinisk hensigtsmæssigt.
English: Very common (may affect more than 1 in 10 people) - stomach ache - feeling sick (nausea) - vomiting - diarrhoea - loss of appetite
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 behandlede) - mavesmerter - kvalme - opkastning - diarre - appetitløshed
English: very rare very rare lactic acidosis very rare very rare
Danish: Laktacidose meget sjælden meget sjælden
English: common common macular oedema not known not known
Danish: Makulaødem ikke kendt ikke kendt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE (MED BLÅ BOKS) (EKSKL.
English: How to take Competact
Danish: Sådan skal de tage competact
English: Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Competact and have also been reported in male patients (frequency cannot be estimated from the available data) taking Competact.
Danish: Knoglebrud har været almindeligt forekommende (kan påvirke op til 1 ud af 10 behandlede) hos kvindelige patienter, der tager Competact, og er ligeledes indberettet hos mandlige patienter
English: Musculoskeletal and connective tissue disorders bone fracture6
Danish: Knogler, led, muskler og bindevæv knoglefraktur6
English: 14 Tablet blister
Danish: Blister med 14 tabletter
English: Mon. 2
Danish: Man. 1 Man. 2
English: What is in this leaflet:
Danish: Det er især vigtigt, at du nævner følgende:
English: It is especially important to mention the following: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) - cimetidine (used to reduce stomach acid) - glucocorticoids (used to treat inflammation) - beta-2-agonists (used to treat asthma) - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) - certain medicines for the treatment of high blood pressure (angiotensin-converting enzyme
Danish: - gemfibrozil (bruges til at sænke kolesteroltallet) - rifampicin (bruges til behandling af tuberkulose og andre infektioner) - cimetidin (bruges til behandling af for meget mavesyre) - glukokortikoider (bruges til behandling af vævsirritation) - beta-2-agonister (bruges til behandling af astma) - vanddrivende lægemidler (diuretika) - lægemidler mod smerter og betændelseslignende tilstande (NSAID'er og COX-2-hæmmere,
English: Your doctor will check whether Competact is working 3 to 6 months after you start taking it.
Danish: Når De har taget Competact i 3-6 måneder, vil Deres læge undersøge, om medicinen virker.
English: - if you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties.
Danish: - hvis De for nyligt har haft et hjertetilfælde, eller har haft alvorlige kredsløbsproblemer,
English: 8 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Danish: 8I kontrollerede kliniske forsøg med aktive komparator var den gennemsnitlige vægtøgning 2-3 kg i løbet af et år med pioglitazon givet som monoterapi.
English: Competact 15 mg/850 mg film-coated tablets
Danish: Competact 15 mg/850 mg filmovertrukne tabletter
English: - if you have a problem with your liver.
Danish: - hvis De har leverproblemer.
English: Ask your doctor or pharmacist for more information if you are not sure how to recognise this.
Danish: Tal med lægen eller apotekspersonalet, hvis De er i tvivl om, hvordan De genkender disse symptomer.
English: Infections and infestations upper respiratory tract infection common common sinusitis uncommon uncommon
Danish: Infektioner og parasitære sygdomme øvre luftvejsinfektion almindelig almindelig
English: 3 Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens.
Danish: Disse er relateret til ændringer i blodglucose, som forårsager forbigående ændringer i linsens turgiditet og refraktionsindeks.
English: Very rare (may affect up to 1 in 10,000) - decrease in amount of vitamin B12 in the blood - redness of the skin - itchy skin - raised and itchy rash (hives)
Danish: Meget sjældne(kan forekomme hos op til 1 ud af 10.000 brugere) - nedsat indhold af cyanocobalamin (vitamin B12) i blodet - hudrødme - hudkløe - hævet og kløende udslæt (nældefeber)
English: - if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision.
Danish: - hvis De lider af en særlig øjenlidelse hos diabetikere, som hedder makulaødem (væskeansamling i det bagerste af øjet).
English: Competact should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.5.
Danish: Behandling med Competact skal afbrydes forud for eller på tidspunktet for billeddiagnostiske procedurer og først genoptages mindst 48 timer herefter, forudsat at nyrefunktionen er blevet vurderet og fundet stabil, se pkt.
English: Competact must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.
Danish: Behandling med Competact skal afbrydes forud for eller på tidspunktet for en billeddiagnostisk procedure og først genoptages efter mindst 48 timer, forudsat at nyrefunktionen er blevet vurderet og fundet stabil, se pkt.
English: Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure (see section 4.4).
Danish: Der er rapporteret om hjerteinsufficiens under anvendelse af pioglitazon post-marketing oghyppigere, når pioglitazon bruges i kombination med insulin og hos patienter med tidligere hjerteinsufficiens (se pkt.
English: - do not use Competact if you are breastfeeding or are planning to breast-feed (see section “Do not take Competact”).
Danish: Deres læge vil råde Dem til at stoppe med at tage denne medicin., hvis De ønsker at blive gravid.Tag ikke Competact, hvis De ammer eller ønsker at amme (se afsnittet ”Tag ikke Competact”).
English: Competact should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Danish: Competact bør ikke anvendes hos patienter med nedsat leverfunktion (se pkt.
English: - Acute conditions with the potential to alter renal function such as: Dehydration Severe infection Shock - Intravascular administration of iodinated contrast agents (see section 4.4) - Breast-feeding (see section 4.6)
Danish: dehydrering svær infektion shock - intravaskulær administration af iodholdige kontrastmidler (se pkt.
English: Mon.
Danish: Man.
English: recent myocardial infarction, shock - Hepatic impairment - Acute alcohol intoxication, alcoholism - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) - Diabetic pre-coma - Severe renal failure (GFR < 30 mL/min)
Danish: 6.1e - svigtende hjertefunktion eller en anamnese med hjertesvigt (NYHA-klasse I til IV) - blærecancer i anamnesen - ikke udredt makroskopisk hæmaturi - akut eller kronisk sygdom, som kan medføre vævshypoxi såsom hjerte- eller respirationsinsufficiens, nyligt myokardieinfarkt, shock - nedsat leverfunktion - akut alkoholforgiftning, alkoholisme - enhver type af akut metabolisk acidose (såsom laktatacidose, diabetisk ketoacidose) - diabetisk prækoma - svær nyreinsufficiens (GFR < 30 ml/min) - akutte tilstande, der muligvis kan forværre nyrefunktionen, såsom:
English: In case of suspected symptoms, the patient should stop taking Competact and seek immediate medical attention.
Danish: Patienterne skal informeres om at stoppe med at tage Competact og øjeblikkeligt søge lægehjælp ved symptomer, der kan give mistanke om laktatacidose.
English: Blood and lymphatic system disorders anaemia common
Danish: Blod og lymfesystem
English: 6 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Danish: 6I en poolet analyse af bivirkninger i form af knoglefrakturer fra randomiserede, komparatorkontrollerede, dobbeltblindede kliniske forsøg af op til 3,5 års varighed med over 8.100 patienter i den pioglitazonbehandlede gruppe og 7.400 patienter i den komparatorbehandlede gruppe blev der observeret en øget hyppighed af frakturer hos kvinder, der fik pioglitazon (2,6 %) sammenlignet med komparator (1,7 %).
English: Package leaflet: Information for the patient Competact 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride
Danish: Indlægsseddel: Information til patienten Competact 15 mg/850 mg filmovertrukne tabletter pioglitazon/metforminhydrochlorid
English: Investigations weight increased8
Danish: Undersøgelser vægtøgning7
English: Taking Competact with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
Danish: De gastrointestinale symptomer forbundet med metformin kan reduceres, hvis Competact tages i forbindelse med eller umiddelbart efter et måltid.
English: Dose reduction may be considered in relation to declining renal function.
Danish: Der bør udvises særlig forsigtighed i situationer, hvor nyrefunktionen kan blive forringet.
English: Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Danish: Kontakt lægen, hvis Deres vægt stiger.
English: - if you have uncontrolled diabetes, with for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section“Risk of lactic acidosis”) or ketoacidosis.
Danish: (højt blodsukker), kvalme, opkastning, diarré, hurtigt vægttab, laktatacidose (se afsnittet ”Risiko for laktatacidose”) eller ketoacidose.
English: Competact 15 mg/850 mg tablets pioglitazone/metformin hydrochloride
Danish: Competact 15 mg/850 mg tabletter pioglitazon/metforminhydrochlorid
English: - if you are going to have a certain type of X-ray with an injectable dye, talk to your doctor as you must stop taking Competact for a certain period of time before and after the examination.
Danish: Tal med lægen, da De skal holde op med at tage Competact i en periode før og efter undersøglsen.
English: Uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - gas - difficulty sleeping (insomnia)
Danish: Ikke almindelige(kan ramme op til 1 ud af 100 behandlede) - bihulebetændelse - luft i maven - søvnløshed
English: An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials (see section 4.8)
Danish: I en poolet analyse af bivirkninger i form af knoglefrakturer fra randomiserede, kontrollerede, dobbeltblindede kliniske forsøg blev der set en øget hyppighed af frakturer hos kvinder.
English: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
Danish: dehydrering (væskemangel se yderligere oplysninger nedenfor), leverproblemer og enhver tilstand med nedsat iltforsyning til en legemsdel (såsom akut alvorlig hjertesygdom).
English: Skin and subcutaneous tissue disorders erythema very rare very rare pruritis very rare very rare urticaria very rare very rare
Danish: Urticaria meget sjælden meget sjælden
English: Competact 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride
Danish: Competact 15 mg/850 mg filmovertrukne tabletter pioglitazon/metforminhydrochlorid
English: (ACE) inhibitors and angiotensin II receptor antagonists)
Danish: såsom ibuprofen og celecoxib) - visse lægemidler, der nedsætter blodtrykket (angiotensinkonverterende enzym (ACE)-hæmmere og angiotensin II-receptorantagonister)
English: Gastrointestinal disorders4
Danish: Mave-tarm-kanalen4
English: Also, if you already have blurred vision and the symptoms get worse, talk to your doctor as soon as possible.
Danish: De skal også kontakte Deres læge hurtigst muligt, hvis De allerede har sløret syn, og symptomerne forværres.
English: Lactic acidosis is a serious reaction which may occur very rarely (< 1/10,000) (see section 4.4) and other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Danish: Andre bivirkninger såsom knoglefraktur, vægtøgning og ødem er almindeligt forekommende (≥ 1/100 til < 1/10) (se pkt.
English: What Competact is and what it is used for What you need to know before you take Competact How to take Competact
Danish: Det skal De vide, før De begynder at tage Competact Sådan skal De tage Competact Bivirkninger
English: If you take more Competact than you should
Danish: Hvis De har taget for mange Competact
English: abdominal pain very common very common diarrhoea very common very common flatulence uncommon loss of appetite very common very common nausea very common very common vomiting very common very common
Danish: Appetitløshed meget almindelig meget almindelig
English: Nervous system disorders hypo-aesthesia common common insomnia uncommon uncommon headache common taste disturbance common common
Danish: Hovedpine almindelig smagsforstyrelser almindelig almindelig
English: Eli Lilly Nederland B.V. Tel: +31 (0) 30 60 25 800
Danish: Tel: +31 (0) 30 60 25 800
English: Takeda Pharma A/S Τηλ: +45 46 77 11 11
Danish: Τηλ: +45 46 77 11 11
English: 5 How to store Competact Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: How to store Competact
Danish: Risiko for laktatacidose
English: Wed. 2
Danish: 4.2 og 4.4.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BELANETTE AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF BELANETTE OG TILKNYTTEDE NAVNE (se bilag I)
English: The Belanette blister is glued in a carton which is subsequently folded to a wallet configuration.
Danish: Belanette-blisteren er limet i en pakning, som efterfølgende foldes, så den får form som et omslag.
English: 143, Avenue Louise 1050 Brussel
Danish: 143, Avenue Louise 1050 Brussel Belgien
English: Jenapharm GmbH & Co. KG Otto - Schott - Str. 15 D-07745 Jena
Danish: KG Otto - Schott - Str. 15 D-07745 Jena
English: Germany aida
Danish: Aida
English: • If this happens, you may be able to feel these pieces on your tongue.
Danish: • Hvis det sker, kan du muligvis mærke disse stykker på tungen.
English: Date of first authorisation: 20 July 2011 Date of latest renewal: 18 February 2016
Danish: Dato for første markedsføringstilladelse: 20. juli 2011 Dato for seneste fornyelse: 18. februar 2016
English: See sections 4.4 and 5.1 regarding data in different age groups.
Danish: 4.4 og 5.1 vedrørende data for forskellige aldersgrupper.
English: Not known (frequency cannot be estimated from the available data)
Danish: Ukendt (hyppigheden kan ikke vurderes ud fra de tilgængelige data)
English: Data in different age groups
Danish: Data fra forskellige aldersgrupper
English: Take the other 3 capsules in the same way.
Danish: Tag de resterende 3 kapsler på samme måde.
English: This analysis did not show gender or age-related pharmacokinetic differences
Danish: Denne analyse viste ikke køns- eller aldersrelaterede farmakokinetiske forskelle.
English: Some people do not get this infection until later on in their lives, while others get it very young.
Danish: Nogle får først denne infektion senere i livet, mens andre får den meget tidligt.
English: Otherwise, wait for your next dose.
Danish: Ellers vent til næste dosis.
English: There are insufficient data in this population to support a recommendation for or against dose adjustment.
Danish: Der foreligger ikke tilstrækkelige data om denne population til at støtte en anbefaling for eller imod dosisjustering.
English: • Do not press the piercing button more than once at a time.
Danish: • Tryk ikke på perforeringsknappen mere end en gang ad gangen.
English: • You are now ready to inhale the capsule in 2 separate breaths (Steps 8 and 9).
Danish: • Du er nu klar til at inhalere kapslen i to separate åndedrag (trin 8 og 9).
English: • 7 capsule cards (one card for each day of the week).
Danish: • 7 kapselkort (et kort til hver dag i ugen).
English: A difference in FEV1 response by age was noted.
Danish: Der blev noteret en aldersmæssig forskel i FEV1-respons.
English: What is Pseudomonas aeruginosa
Danish: Hvad er Pseudomonas aeruginosa
English: Should cough remain unchanged, other antibiotics should be considered.
Danish: Skulle hosten forblive uændret, skal andre antibiotika overvejes.
English: The frequencies in Table 1 are based on the reporting rates from the active-controlled study.
Danish: Frekvenserne i Tabel 1 er baseret på rapporteringshyppigheder fra det aktiv-kontrollerede studie.
English: Talk to your doctor if the cough is persistent and is a burden for you.
Danish: Tal med din læge, hvis hosten bliver ved og er en belastning for dig.
English: Use this if your weekly inhaler is not functioning correctly, is wet, or has dropped on the ground.
Danish: Brug den, hvis din ugentlige inhalator ikke fungerer korrekt, er våd eller har været tabt på jorden.
English: Occasionally, very small pieces of the capsule can get past the screen and get into your mouth.
Danish: Undertiden kan meget små stykker af kapslen passere gennem nettet og ind i munden.
English: The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters.
Danish: De hårde kapsler leveres i PVC/PA/Alu/PVC- PET/Alu-blisterpakninger.
English: The dose is the same for everyone aged 6 years and older.
Danish: Dosis er den samme for alle fra 6 år og opefter.
English: The dose of TOBI Podhaler is the same for all patients within the approved age range, regardless of age or weight.
Danish: Dosis af TOBI Podhaler er den samme for alle patienter indenfor de godkendte aldersgrupper, uanset alder og vægt.
English: Do not take the capsules out of the card in advance.
Danish: Lad være med at tage kapslerne ud af kortet på forhånd.
English: You then start another course.
Danish: Derefter starter du forfra.
English: Repeat, starting at step 5, for the remaining three capsules of the dose.
Danish: Gentag fra trin 5 med de resterende tre kapsler af dosis.
English: MIC increases observed were in large part reversible during offtreatment periods.
Danish: De observerede MIC-stigninger var for en stor dels vedkommende reversible i de behandlingsfrie perioder.
English: • It is best to leave close to 12 hours between doses, but this must be at least 6 hours
Danish: • Der skal helst være tæt på 12 timer mellem to doser, men der skal være mindst 6 timer imellem.
English: Tell your doctor if you have ever had any of the following conditions:
Danish: Sig det til din læge, hvis du nogensinde har haft følgende:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for indsendelse af periodiske, opdaterede sikkerhedsindberetninger dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.