FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of bioequivalence studies in healthy subjects demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
Danish: Bioækvivalensstudier af raske forsøgspersoner viser, at Incresync, filmovertrukne--tabletter er bioækvivalente med tilsvarende doser af alogliptin og pioglitazon givet samtidigt som separate tabletter.
English: Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis (see section 4.2).
Danish: Incresync anbefales ikke til patienter med svært nedsat nyrefunktion eller med dialysekrævende terminal nyresygdom (se pkt.
English: INFORMATION IN BRAILLE Incresync 12.5 mg/30 mg
Danish: INFORMATION I BRAILLE-SKRIFT Incresync 12,5 mg/30 mg
English: INFORMATION IN BRAILLE Incresync 12.5 mg/45 mg
Danish: INFORMATION I BRAILLE-SKRIFT Incresync 12,5 mg/45 mg
English: Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
Danish: Efter markedsføring er der set sjældne tilfælde af forhøjede leverenzymtal og hepatocellulær dysfunktion.
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 serum concentration of pioglitazone (see section 4.5).
Danish: Der er set henholdsvis en forøgelse og en nedsættelse af plasmakoncentrationen af pioglitazon ved samtidig administration af pioglitazon og gemfibrozil (en hæmmer af cytochrom P450 2C8) eller rifampicin (en induktor af cytokrom P450 2C8) (se pkt.
English: INFORMATION IN BRAILLE Incresync 25 mg/30 mg
Danish: INFORMATION I BRAILLE-SKRIFT Incresync 25 mg/30 mg
English: Additional symptoms may include general itching and feeling of heat especially affecting the scalp, mouth, throat, palms of hands and soles of feet (Stevens-Johnson syndrome).
Danish: De tegn, du skal være opmærksom på, er kløe, en følelse af varme især i hovedbund, mund, hals, håndflader og fodsåler (Stevens-Johnsons syndrom).hvis du lider af hjertesvigt eller tidligere har haft hjertesvigt.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon
Danish: cyster og polypper) blærecancer ikke almindelig
English: tel. +48 22 608 13 00
Danish: Takeda Polska Sp. z o.o tel. +48 22 608 13 00
English: Alogliptin 25 mg
Danish: Antal patienter (%) Alogliptin 25 mg
English: Iron oxide yellow (E172)
Danish: Rød jernoxid (E172)
English: This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
Danish: Dette sker fortrinsvis via cytokrom P450 2C8, selvom andre isoformer kan være involveret i mindre grad. Tre af de seks identificerede pioglitazon-metabolitter er aktive (M-II, M-III og M-IV).
English: Red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/45” printed in grey ink on one side.
Danish: Røde, runde (ca. 8,7 mm i diameter), bikonvekse, filmovertrukne tabletter med både "A/P" og "25/45" trykt i gråt på den ene side.
English: No dose adjustment of Incresync for patients with mild renal impairment is necessary (see section 4.2).
Danish: Nedsat leverfunktion Incresync må ikke gives til patienter med nedsat leverfunktion (se pkt.
English: and lower than the incidence in patients treated with active-control or placebo (0.1%, 0.1%, 0.4% and 0.4%, respectively).
Danish: Den samlede forekomst af episoder med svær hypoglykæmi var på samme niveau hos patienter behandlet med 25 mg alogliptin eller 12,5 mg alogliptin, og dette niveau var lavere end forekomsten hos patienter behandlet med aktiv kontrol eller placebo (henholdsvis 0,1 %, 0,1 %, 0,4 % og 0,4 %).
English: - Incresync 25 mg/45 mg film-coated tablets (tablets) are red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/45” printed in grey ink on one side.
Danish: - Incresync 25 mg/45 mg filmovertrukne tabletter (tabletter) er røde, runde (ca. 8,7 mm i diameter), bikonvekse, filmovertrukne tabletter med både "A/P" og"25/45" trykt i gråt på den ene side.
English: What Incresync looks like and contents of the pack - Incresync 25 mg/30 mg film-coated tablets (tablets) are peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/30” printed in grey ink on one side.
Danish: Udseende og pakningstørrelser - Incresync 25 mg/30 mg filmovertrukne tabletter (tabletter) er ferskenfarvede, runde (ca. 8,7 mm i diameter), bikonvekse, filmovertrukne tabletter med både "A/P" og"25/30" trykt i gråt på den ene side.
English: Incresync 25 mg/30 mg film-coated tablets
Danish: Incresync 25 mg/30 mg filmovertrukne tabletter
English: Post-marketing spontaneous reports of hypersensitivity reactions in patients treated with pioglitazone include anaphylaxis, angioedema, and urticaria.
Danish: Efter markedsføring har der været spontane indberetninger om overfølsomhedsreaktioner hos patienter behandlet med pioglitazon.
English: Incresync 25 mg/45 mg film-coated tablets
Danish: Incresync 25 mg/45 mg filmovertrukne tabletter
English: Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Danish: Hver 25 mg/45 mg filmovertrukken tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 25 mg alogliptin og 45 mg pioglitazon.
English: 25 mg/30 mg film-coated tablets
Danish: 25 mg/30 mg filmovertrukne tabletter
English: 12.5 mg/45 mg film-coated tablets
Danish: 12,5 mg/45 mg filmovertrukne tabletter
English: Mean change from baseline in HbA1c (%)† (SE)
Danish: Gennemsnitlig ændring i HbA1c fra baseline (%)†
English: Each 12.5 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
Danish: Hver 12,5 mg/45 mg filmovertrukken tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 12,5 mg alogliptin og 45 mg pioglitazon.
English: 25 mg/45 mg film-coated tablets
Danish: 25 mg/45 mg filmovertrukne tabletter
English: Hepatobiliary disorders hepatic dysfunction including hepatic failure not known
Danish: Lever og galdeveje leverfdysunktion, herunder leversvigt ikke kendt
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Incresync.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerarter.
English: Incresync 12.5 mg/30 mg film-coated tablets
Danish: Incresync 12,5 mg/30 mg filmovertrukne tabletter
English: Pharmacotherapeutic group: Drugs used in diabetes; combinations of oral blood glucose lowering drugs.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika; komb.
English: Incresync 12.5 mg/45 mg film-coated tablets
Danish: Incresync 12,5 mg/45 mg filmovertrukne tabletter
English: - Incresync 12.5 mg/30 mg film-coated tablets (tablets) are pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/30” printed in red ink on one side.
Danish: - Incresync 12,5 mg/30 mg filmovertrukne tabletter (tabletter) er svagt ferskenfarvede, runde (ca. 8,7 mm i diameter), bikonvekse, filmovertrukne tabletter med både "A/P" og"12.5/30" trykt i rødt på den ene side.
English: What Incresync is and what it is used for What you need to know before you take Incresync How to take Incresync
Danish: Det skal du vide, før du begynder at tage Incresync Sådan skal du tage Incresync Bivirkninger
English: Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Danish: Hver 25 mg/30 mg filmovertrukken tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 25 mg alogliptin og 30 mg pioglitazon.
English: Printing ink 12.5 mg/30 mg film-coated tablets
Danish: Blæk til prægning 12,5 mg/30 mg filmovertrukne tabletter
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Danish: Hver tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 12,5 mg alogliptin og 30 mg pioglitazon.
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Danish: Hver tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 25 mg alogliptin og 45 mg pioglitazon.
English: - Incresync 12.5 mg/45 mg film-coated tablets (tablets) are pale red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/45” printed in red ink on one side.
Danish: - Incresync 12,5 mg/45 mg filmovertrukne tabletter (tabletter) er svagt røde, runde (ca. 8,7 mm i diameter), bikonvekse, filmovertrukne tabletter med både "A/P" og"12.5/45" trykt i rødt på den ene side.
English: Pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “12.5/30” printed in red ink on one side.
Danish: Svagt ferskenfarvede, runde (ca. 8,7 mm i diameter), bikonvekse, filmovertrukne tabletter med både "A/P" og "12.5/30" trykt i rødt på den ene side.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 25 mg alogliptin (som benzoat) og 45 mg pioglitazon (som hydrochlorid).
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
Danish: Hver tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 12,5 mg alogliptin og 45 mg pioglitazon.
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg tablets alogliptin/pioglitazone
Danish: LÆGEMIDLETS NAVN Incresync 25 mg/45 mg tabletter alogliptin/pioglitazon
English: Possible side effects
Danish: Tabel 1: Bivirkninger
English: Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Danish: Hver 12,5 mg/30 mg filmovertrukken tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 12,5 mg alogliptin og 30 mg pioglitazon.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 12,5 mg alogliptin (som benzoat) og 30 mg pioglitazon (som hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg tablets alogliptin/pioglitazone
Danish: LÆGEMIDLETS NAVN Incresync 12,5 mg/45 mg tabletter alogliptin/pioglitazon
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Danish: Hver tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 25 mg alogliptin og 30 mg pioglitazon.
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone
Danish: LÆGEMIDLETS NAVN Incresync 25 mg/30 mg tabletter alogliptin/pioglitazon
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 12,5 mg alogliptin (som benzoat) og 45 mg pioglitazon (som hydrochlorid).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 25 mg alogliptin (som benzoat) og 30 mg pioglitazon (som hydrochlorid).
English: Peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/30” printed in grey ink on one side.
Danish: Ferskenfarvede, runde (ca. 8,7 mm i diameter), bikonvekse, filmovertrukne tabletter med både "A/P" og"25/30" trykt i gråt på den ene side.
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg tablets alogliptin/pioglitazone
Danish: LÆGEMIDLETS NAVN Incresync 12,5 mg/30 mg tabletter alogliptin/pioglitazon
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8)
Danish: 6.1 eller en tidligere alvorlig overfølsomhedsreaktion, herunder anafylaktisk reaktion,
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
Danish: LÆGEMIDLETS NAVN Incresync 25 mg/45 mg filmovertrukne tabletter alogliptin/pioglitazon
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg film-coated tablets alogliptin/pioglitazone
Danish: LÆGEMIDLETS NAVN Incresync 25 mg/30 mg filmovertrukne tabletter alogliptin/pioglitazon
English: Treatment-corrected change from baseline in HbA1c (%)†
Danish: Behandlingskorrigeret ændring i HbA1c fra baseline
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg film-coated tablets alogliptin/pioglitazone
Danish: LÆGEMIDLETS NAVN Incresync 12,5 mg/45 mg filmovertrukne tabletter alogliptin/pioglitazon
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg film-coated tablets alogliptin/pioglitazone
Danish: LÆGEMIDLETS NAVN Incresync 12,5 mg/30 mg filmovertrukne tabletter alogliptin/pioglitazon
English: EU/1/13/842/001 10 film-coated tablets EU/1/13/842/002 14 film-coated tablets EU/1/13/842/003 28 film-coated tablets EU/1/13/842/004 30 film-coated tablets EU/1/13/842/005 56 film-coated tablets EU/1/13/842/006 60 film-coated tablets EU/1/13/842/007 90 film-coated tablets EU/1/13/842/008 98 film-coated tablets EU/1/13/842/009 100 film-coated tablets
Danish: EU/1/13/842/001 10 filmovertrukne tabletter EU/1/13/842/002 14 filmovertrukne tabletter EU/1/13/842/003 28 filmovertrukne tabletter EU/1/13/842/004 30 filmovertrukne tabletter EU/1/13/842/005 56 filmovertrukne tabletter EU/1/13/842/006 60 filmovertrukne tabletter EU/1/13/842/007 90 filmovertrukne tabletter EU/1/13/842/008 98 filmovertrukne tabletter EU/1/13/842/009 100 filmovertrukne tabletter
English: EU/1/13/842/019 10 film-coated tablets EU/1/13/842/020 14 film-coated tablets EU/1/13/842/021 28 film-coated tablets EU/1/13/842/022 30 film-coated tablets EU/1/13/842/023 56 film-coated tablets EU/1/13/842/024 60 film-coated tablets EU/1/13/842/025 90 film-coated tablets EU/1/13/842/026 98 film-coated tablets EU/1/13/842/027 100 film-coated tablets
Danish: EU/1/13/842/019 10 filmovertrukne tabletter EU/1/13/842/020 14 filmovertrukne tabletter EU/1/13/842/021 28 filmovertrukne tabletter EU/1/13/842/022 30 filmovertrukne tabletter EU/1/13/842/023 56 filmovertrukne tabletter EU/1/13/842/024 60 filmovertrukne tabletter EU/1/13/842/025 90 filmovertrukne tabletter EU/1/13/842/026 98 filmovertrukne tabletter EU/1/13/842/027 100 filmovertrukne tabletter
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac, carnauba wax and glycerol mono-oleate.
Danish: - Øvrige indholdsstoffer: mannitol, mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmelosenatrium, magnesiumstearat, lactosemonohydrat, hypromellose, talkum, titandioxid (E171), rød jernoxid (E172), macrogol 8000, shellac, carnaubavoks og glycerol mono-oleat.
English: EU/1/13/842/028 10 film-coated tablets EU/1/13/842/029 14 film-coated tablets EU/1/13/842/030 28 film-coated tablets EU/1/13/842/031 30 film-coated tablets EU/1/13/842/032 56 film-coated tablets EU/1/13/842/033 60 film-coated tablets EU/1/13/842/034 90 film-coated tablets EU/1/13/842/035 98 film-coated tablets EU/1/13/842/036 100 film-coated tablets
Danish: EU/1/13/842/028 10 filmovertrukne tabletter EU/1/13/842/029 14 filmovertrukne tabletter EU/1/13/842/030 28 filmovertrukne tabletter EU/1/13/842/031 30 filmovertrukne tabletter EU/1/13/842/032 56 filmovertrukne tabletter EU/1/13/842/033 60 filmovertrukne tabletter EU/1/13/842/034 90 filmovertrukne tabletter EU/1/13/842/035 98 filmovertrukne tabletter EU/1/13/842/036 100 filmovertrukne tabletter
English: EU/1/13/842/010 10 film-coated tablets EU/1/13/842/011 14 film-coated tablets EU/1/13/842/012 28 film-coated tablets EU/1/13/842/013 30 film-coated tablets EU/1/13/842/014 56 film-coated tablets EU/1/13/842/015 60 film-coated tablets EU/1/13/842/016 90 film-coated tablets EU/1/13/842/017 98 film-coated tablets EU/1/13/842/018 100 film-coated tablets
Danish: EU/1/13/842/010 10 filmovertrukne tabletter EU/1/13/842/011 14 filmovertrukne tabletter EU/1/13/842/012 28 filmovertrukne tabletter EU/1/13/842/013 30 filmovertrukne tabletter EU/1/13/842/014 56 filmovertrukne tabletter EU/1/13/842/015 60 filmovertrukne tabletter EU/1/13/842/016 90 filmovertrukne tabletter EU/1/13/842/017 98 filmovertrukne tabletter EU/1/13/842/018 100 filmovertrukne tabletter
English: 12.5 mg/30 mg film-coated tablets
Danish: Filmovertræk 12,5 mg/30 mg filmovertrukne tabletter
English: Current bladder cancer or a history of bladder cancer (see section 4.4) Uninvestigated macroscopic haematuria (see section 4.4)
Danish: 4.4) - Ikke-udredt makroskopisk hæmaturi (se pkt.
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac, carnauba wax and glycerol mono-oleate.
Danish: - Øvrige indholdsstoffer: mannitol, mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmelosenatrium, magnesiumstearat, lactosemonohydrat, hypromellose, talkum, titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172), macrogol 8000, shellac, carnaubavoks og glycerol mono-oleat.
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Danish: - Øvrige indholdsstoffer: mannitol, mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmelosenatrium, magnesiumstearat, lactosemonohydrat, hypromellose, talkum, titandioxid (E171), rød jernoxid (E172), macrogol 8000, shellac, og sort jernoxid (E172).
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Danish: - Øvrige indholdsstoffer: mannitol, mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmelosenatrium, magnesiumstearat, lactosemonohydrat, hypromellose, talkum, titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172), macrogol 8000, shellac, og sort jernoxid (E172).
English: Incresync should not be used during pregnancy or breast-feeding.
Danish: Du må ikke tage Incresync, hvis du er gravid eller ammer.
English: • The package leaflet
Danish: • Indlægsseddel
English: This summary was last updated in 06-2016.
Danish: Dette sammendrag blev senest ajourført i 06-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vizamyl on 22 August 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vizamyl den 22. august 2014.
English: This is a summary of the European public assessment report (EPAR) for Vizamyl.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vizamyl.
English: The full EPAR and risk management plan summary for Vizamyl can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Vizamyl findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Vizamyl is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vizamyl anvendes så sikkert som muligt.
English: Other information about Vizamyl
Danish: Andre oplysninger om Vizamyl
English: What is Vizamyl and what is it used for?
Danish: Hvad er Vizamyl, og hvad anvendes det til?
English: A later re-analysis looked again at data from the original 68 patients together with results from others who had died after the end of the original study, making a total of 106 patients.
Danish: Der blev efterfølgende foretaget en fornyet analyse af data fra de oprindelige 68 patienter sammenlagt med resultaterne fra dem, der var døde efter afslutningen af den oprindelige undersøgelse, i alt 106 patienter.
English: In this re-analysis most readers could interpret the scans with a sensitivity of around 91% (91% of patients who had plaques were identified) and a specificity of 90% (90% of patients without plaques were correctly rated as not having plaques).
Danish: I denne fornyede analyse kunne de fleste af undersøgerne tolke skanningerne med en følsomhed på ca. 91 % (91 % af de patienter, der havde plak, blev identificeret), og en specificitet på 90 % (90 % af de patienter, der ikke havde plak, blev korrekt vurderet til at være uden plak).
English: What measures are being taken to ensure the safe and effective use of Vizamyl?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vizamyl?
English: Doctors will therefore need to use the scan together with a clinical evaluation.
Danish: Lægerne skal derfor bruge skanningen sammen med en klinisk vurdering.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vizamyl's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Vizamyl overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It is not intended to provide practical advice on how to use Vizamyl.
Danish: Det er ikke en praktisk vejledning i, hvordan Vizamyl bør anvendes.
English: The most common side effects with Vizamyl (seen in between 1 and 10 patients in 100) are flushing (reddening of the skin) and increased blood pressure.
Danish: De almindeligste bivirkninger med Vizamyl (der ses hos mellem 1 og 10 ud af hver 100 behandlede) er rødme af huden og forhøjet blodtryk.
English: What are the risks associated with Vizamyl?
Danish: Hvilke risici er der forbundet med Vizamyl?
English: Why is Vizamyl approved?
Danish: Hvorfor er Vizamyl blevet godkendt?
English: The type of scan used with Vizamyl is called positron-emission tomography (PET).
Danish: Den type skanning, hvor Vizamyl anvendes, er positronemissionstomografi (PET).
English: In addition, the company that markets Vizamyl will provide access to a training course for all nuclearmedicine physicians expected to use this product in the European Union, in order to ensure accurate and reliable reading of the PET scan images.
Danish: Den virksomhed, der markedsfører Vizamyl, skal desuden tilbyde et kursus til alle speciallæger i nuklearmedicin, der forventes at anvende dette produkt i EU, for at sikre en nøjagtig og pålidelig vurdering af PET-skanningerne.
English: In terms of safety, Vizamyl involves exposure of the patient to small amounts of radiation, which is in the range of other approved radiopharmaceuticals, and the safety profile is therefore acceptable.
Danish: Hvad sikkerheden angår, indebærer brug af Vizamyl, at patienten udsættes for stråling i samme små mængder som fra andre godkendte radioaktive lægemidler, og sikkerhedsprofilen er derfor acceptabel.