FrancophonIA/ELRC3.0 huggingface dataset:
English: What Glubrava looks like and contents of the pack 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 (tabletter) er hvide til offwhite, aflange, konvekse, mærket med '15 / 850' på den ene side og ‘4833M' på den anden side.
English: Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Danish: Dette sker fortrinsvis via CYP2C8, selvom andre isoformer kan være involveret i mindre grad. Tre af de seks identificerede metabolitter er aktive (M-II, M-III og M-IV).
English: Each tablet contains 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
Danish: Hver tablet indeholder 15 mg pioglitazon (som hydrochlorid) og 850 mg metforminhydrochlorid.
English: Thiazolidinediones act primarily by reducing insulin resistance and biguanides act primarily by decreasing endogenous hepatic glucose production.
Danish: Biguaniderne virker primært ved at mindske den endogene hepatiske glukoseproduktion.
English: Glubrava should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Danish: Glubrava bør ikke anvendes hos patienter med nedsat leverfunktion (se pkt.
English: How to take Glubrava
Danish: Sådan skal De tage Glubrava
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 Glubrava for a certain period of time before and after the examination.
Danish: skal De tale med Deres læge, da De skal holde op med at tage Glubrava i en vis periode inden og efter undersøgelsen.
English: There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Danish: Efter markedsføring er der rapporteret tilfælde af hjerteinsufficiens, hvor pioglitazon har været anvendt i kombination med insulin eller hvor pioglitazon har været anvendt hos patienter med hjerteinsufficiens i anamnesen.
English: If you experience any of these, talk to your doctor as soon as possible.
Danish: Hvis De oplever nogen af disse symptomer, skal De hurtigst muligt kontakte Deres læge.
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: This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
Danish: Den forsinkede fostervækst skyldtes, at pioglitazon mindskede den maternale hyperinsulinæmi og en øget insulinresistens, som optræder under graviditet.
English: 28 tablets
Danish: 28 tabletter
English: by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation by delaying intestinal glucose absorption.
Danish: Metformin kan virke via tre mekanismer: - ved at reducere den hepatiske glucoseproduktion ved hæmning af gluconeogenese og glycogenolyse - i muskler, ved forøgelse af insulinfølsomheden, forbedring af perifer glucoseoptagelse og
English: Glubrava 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 Glubrava 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: What Glubrava contains The active substances are pioglitazone and metformin hydrochloride.
Danish: Glubrava indeholder: - Aktive stoffer: pioglitazon (som hydrochlorid) og metforminhydrochlorid.
English: 98 tablets
Danish: 98 tabletter
English: 8 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Danish: I kontrollerede kliniske forsøg med aktive komparator var den gennemsnitlige vægtøgning 2-3 kg i løbet af et år med pioglitazon givet som monoterapi.
English: Glubrava 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 Glubrava 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: 90 tablets
Danish: 90 tabletter
English: If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis De ved en fejltagelse har taget for mange tabletter, eller hvis en anden eller et barn tager Deres medicin.
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 blodsukkeret, som forårsager forbigående ændringer i linsens turgiditet og refraktionsindeks.
English: 30 tablets
Danish: 30 tabletter
English: common common macular oedema not known not known
Danish: Øjne synsforstyrrelser almindelig almindelig makulaødem ikke kendt ikke kendt
English: In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Danish: I in vitro forsøg er der ikke vist hæmning af nogen CYP-undertyper.
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 (se pkt.
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Glubrava.
Danish: Blærekræft forekommer med hyppigheden "ikke almindelig" hos patienter, der tager Glubrava (kan ramme op til 1 ud af 100 behandlede).
English: 6 A pooled analysis was conducted of adverse event reports 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 rapporterede uønskede hændelser 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: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Danish: Der er rapporter om, at samtidig administration af pioglitazon og gemfibrozil (en CYP2C8-hæmmer) har resulteret i en tredobbelt stigning i AUC for pioglitazon.
English: 60 tablets
Danish: 60 tabletter
English: Infections and infestations upper respiratory tract infection common common sinusitis uncommon uncommon
Danish: Infektioner og parasitære sygdomme øvre luftvejsinfektion almindelig almindelig sinuitis ikke almindelig ikke almindelig benigne, maligne og uspecificerede tumorer (inkl.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon
Danish: cyster og polypper) blærecancer ikke almindelig ikke almindelig
English: 50 tablets
Danish: 50 tabletter
English: NAME OF THE MEDICINAL PRODUCT Glubrava 15 mg/850 mg tablets pioglitazone/metformin hydrochloride
Danish: LÆGEMIDLETS NAVN Glubrava 15 mg/850 mg tabletter pioglitazon/metforminhydrochlorid
English: Glubrava 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride
Danish: Glubrava 15 mg/850 mg filmovertrukne tabletter pioglitazon/metforminhydrochlorid
English: In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Danish: I de fleste kliniske forsøg blev der observeret en reduktion af niveauer af total plasma-triglycerider, frie fedtsyrer og en øgning af HDL-kolesterolniveauer sammenlignet med placebo.
English: Taking Glubrava with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
Danish: De gastrointestinale symptomer forbundet med metformin kan reduceres, hvis Glubrava tages i forbindelse med eller umiddelbart efter et måltid.
English: In case of suspected symptoms, the patient should stop taking Glubrava and seek immediate medical attention.
Danish: Patienterne skal informeres om at stoppe med at tage Glubrava og øjeblikkeligt søge lægehjælp ved symptomer, der kan give mistanke om laktatacidose.
English: B e lgië/Belgique/Belgien Takeda Belgium Tél/Tel: +32 2 464 06 11
Danish: België/Belgique/Belgien Takeda Belgium Tél/Tel: +32 2 464 06 11 takeda-belgium@takeda.com
English: Adverse reactions reported in double-blind studies and post-marketing experience are listed below as MedDRA preferred term by system organ class and absolute frequency.
Danish: Bivirkninger, der er rapporteret i dobbeltblindede forsøg og efter markedsføring, er angivet iht.
English: Other:
Danish: Andre:
English: Hepatic impairment
Danish: - svær infektion
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).
Danish: Der er set henholdsvis en øgning og en nedsættelse af plasmakoncentrationen af pioglitazon ved samtidig administration af pioglitazon og gemfibrozil (en hæmmer af CYP2C8) eller rifampicin (en inducer af CYP2C8) (se pkt.
English: Renal and urinary disorders haematuria common
Danish: Nyrer og urinveje hæmaturi almindelig
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 kan forekomme almindeligt (≥ 1/100 til < 1/10) (se pkt.
English: Glubrava 15 mg/850 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Glubrava 15 mg/850 mg filmovertrukne tabletter
English: Intravascular administration of iodinated contrast agents (see section 4.4) Breast-feeding (see section 4.6)
Danish: - shock - intravaskulær administration af iodholdige kontrastmidler (se pkt.
English: Uncommon inflammation of the sinuses (sinusitis) gas difficulty sleeping (insomnia)
Danish: Ikke almindelige - bihulebetændelse - luft i maven - søvnløshed
English: Takeda Italia S.p.A. Tel: +39 06 502601
Danish: Tel: +39 06 502601
English: In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Danish: Her viste glykæmiske kontrolmålinger (målt som middelændringer i HbA1c fra baseline), at de var omtrent de samme de to grupper imellem efter et år.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Cardiac failure or history of cardiac failure (NYHA stages I to IV) Current bladder cancer or a history of bladder cancer Uninvestigated macroscopic haematuria
Danish: 6.1 - 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
English: What Glubrava is and what it is used for What you need to know before you take Glubrava How to take Glubrava
Danish: Det skal De vide, før De begynder at tage Glubrava Sådan skal De tage Glubrava Bivirkninger
English: Sun. 1
Danish: 1 Søn.
English: Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) Diabetic pre-coma
Danish: - 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: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Glubrava.
Danish: Fortæl altid lægen eller på apoteket, hvis De bruger anden medicin, har gjort det for nylig, eller evt. Du skal eventuelt have kontrollere dit blodsukker eller din nyrefunktion hyppigere, eller lægen kan ændre din dosis af Glubrava.Vil tage det Det skyldes, at visse lægemidler kan svække eller forstærke Glubravas effekt på blodsukkerniveauet.
English: Surgery
Danish: Bivirkinger
English: TAKEDA ΕΛΛΑΣ Α.Ε Τηλ: +30 210 6387800
Danish: TAKEDA ΕΛΛΑΣ Α.Ε Τηλ: +30 210 6387800 gr.info@takeda.com
English: Glubrava should be used every day to work properly.
Danish: For at opnå den ønskede virkning skal De tage Glubrava hver dag.
English: Eye disorders
Danish: Øjensygdomme
English: At the initiation of the treatment abdominal pain, diarrhoea, loss of appetite, nausea and vomiting may occur, these reactions are very common but usually disappear spontaneously in most cases.
Danish: I starten af behandlingen kan der forekomme abdominalsmerter, diarre, appetitløshed, kvalme og opkastning.
English: It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Danish: Det er ikke klart, hvorvidt der er en direkte forbindelse mellem pioglitazon og makulært ødem.
English: CARTON
Danish: Amning
English: Hypoglycaemia
Danish: - dehydrering
English: Danmark
Danish: Sverige
English: Posology
Danish: Vægtøgning
English: Musculoskeletal and connective tissue disorders bone fracture6
Danish: Knogler, led, muskler og bindevæv knoglefraktur almindelig almindelig artralgi almindelig
English: Also, if you already have blurred vision and the symptom gets 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: Concomitant use not recommended Alcohol
Danish: Samtidig brug frarådes
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Danish: Efter en oral dosis er den konstaterede terminale eliminationshalveringstid cirka 6,5 timer.
English: Tablet core
Danish: Nedsat nyrefunktion
English: Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: Withdrawal period
Danish: Tilbageholde lsestid
English: This summary was last updated in 08-2014.
Danish: Dette sammendrag blev sidst ajourført i 08-2014.
English: It is available as tablets (25, 50 and 100 mg).
Danish: Det fås som tabletter (25, 50 og 100 mg).
English: The maximum recommended dosing frequency is one tablet per day.
Danish: Den maksimalt anbefalede dosishyppighed er en tablet dagligt.
English: The full EPAR for Sildenafil Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Sildenafil Actavis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Sexual stimulation is still needed to produce an erection.
Danish: Seksuel stimulering er stadig nødvendig for at frembringe en erektion.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil Actavis on 10 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sildenafil Actavis den 10. december 2009.
English: Sildenafil Actavis is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Danish: Sildenafil Actavis anvendes til behandling af voksne mænd med erektil dysfunktion (undertiden kaldet impotens), når de ikke kan få eller fastholde en stiv penis (erektion), som er tilstrækkelig til tilfredsstillende seksuel aktivitet.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, når de danner de samme mængder af det aktive stof i kroppen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sildenafil Actavis.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Sildenafil Actavis.
English: This is a summary of the European public assessment report (EPAR) for Sildenafil Actavis.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sildenafil Actavis.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom severe kidney problems should start treatment with the 25 mg dose.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom mg afhængig af virkning og bivirkninger.
English: The recommended dose of Sildenafil Actavis is 50 mg taken as needed about one hour before sexual activity.
Danish: Den anbefalede dosis Sildenafil Actavis er 50 mg, som tages efter behov ca. 1 time før seksuel aktivitet.
English: This allows blood to flow into the corpora, producing the erection.
Danish: Det får blodet til at strømme ind i corpora, som bevirker erektionen.
English: For more information about treatment with Sildenafil Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sildenafil Actavis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: By blocking the breakdown of cGMP, Sildenafil Actavis restores erectile function.
Danish: Ved at blokere nedbrydningen af cGMP genopretter Sildenafil Actavis den erektile funktion.
English: For Sildenafil Actavis to be effective, sexual stimulation is required.
Danish: For at få Sildenafil Actavis til at virke, kræves der seksuel stimulering.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Danish: Under normal seksuel stimulering produceres der cGMP i penis, hvor det får musklen i svulmelegemet i penis (corpora cavernosa) til at slappe af.
English: The CHMP concluded that, in accordance with EU requirements, Sildenafil Actavis has been shown to have comparable quality and to be bioequivalent to Viagra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Sildenafil Actavis er af sammenlignelig kvalitet og er bioækvivalent med Viagra.
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Danish: Det virker ved at blokere phosphodiesteraseenzymet, som normalt nedbryder et stof kaldet cyklisk guanosinmonophosphat (cGMP).
English: The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Danish: Dosis kan øges til maksimalt 100 mg eller nedsættes til 25
English: Therefore, the CHMP's view was that, as for Viagra, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Viagra.
English: The active ingredient in Sildenafil Actavis, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Det aktive indholdsstof i Sildenafil Actavis, sildenafil, tilhører en gruppe af lægemidler kaldet phosphodiesterase type 5- (PDE5)-hæmmere.
English: The Committee recommended that Sildenafil Actavis be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Sildenafil Actavis.
English: This means that Sildenafil Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Danish: Det betyder, at Sildenafil Actavis er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, nemlig Viagra.
English: Sildenafil Actavis is a ‘generic medicine'.
Danish: Sildenafil Actavis er et ‘generisk lægemiddel'.
English: What are the benefits and risks of Sildenafil Actavis?
Danish: Hvilke fordele og risici er der forbundet med Sildenafil Actavis?
English: Because Sildenafil Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Sildenafil Actavis er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Sildenafil Actavis is a medicine that contains the active substance sildenafil.
Danish: Sildenafil Actavis er et lægemiddel, der indeholder det aktive stof sildenafil.
English: If Sildenafil Actavis is taken with food, the onset of activity may be delayed compared with taking Sildenafil Actavis without food.
Danish: Hvis Sildenafil Actavis tages sammen med et måltid, kan virkningens indtræden forsinkes i forhold til, hvis det tages uden et måltid.
English: Because Sildenafil Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Danish: Da Sildenafil Actavis er et generisk lægemiddel, har undersøgelserne af mennesker været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Viagra.
English: Other information about Sildenafil Actavis
Danish: Andre oplysninger om Sildenafil Actavis
English: Why has Sildenafil Actavis been approved?
Danish: Hvorfor blev Sildenafil Actavis godkendt?
English: What is Sildenafil Actavis?
Danish: Hvad er Sildenafil Actavis?
English: How has Sildenafil Actavis been studied?
Danish: Hvordan blev Sildenafil Actavis undersøgt?
English: What is Sildenafil Actavis used for?
Danish: Hvad anvendes Sildenafil Actavis til?
English: How is Sildenafil Actavis used?
Danish: Hvordan anvendes Sildenafil Actavis?
English: How does Sildenafil Actavis work?
Danish: Hvordan virker Sildenafil Actavis?
English: Netherlands
Danish: Nederlandene
English: Haes-Steril Hes Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 200/0.5
Danish: Haes-Steril Hes Natriumchlorid 9 g/1.000 ml, hydroxyethylstivelse 200/0,5