natgillin/translations-raw huggingface dataset:
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.
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.
Incresync 25 mg/30 mg filmovertrukne tabletter
Incresync 25 mg/30 mg film-coated tablets
Efter markedsføring har der været spontane indberetninger om overfølsomhedsreaktioner hos patienter behandlet med pioglitazon.
Post-marketing spontaneous reports of hypersensitivity reactions in patients treated with pioglitazone include anaphylaxis, angioedema, and urticaria.
Incresync 25 mg/45 mg filmovertrukne tabletter
Incresync 25 mg/45 mg film-coated tablets
Hver 25 mg/45 mg filmovertrukken tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 25 mg alogliptin og 45 mg pioglitazon.
Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
25 mg/30 mg filmovertrukne tabletter
25 mg/30 mg film-coated tablets
12,5 mg/45 mg filmovertrukne tabletter
12.5 mg/45 mg film-coated tablets
Gennemsnitlig ændring i HbA1c fra baseline (%)†
Mean change from baseline in HbA1c (%)† (SE)
Hver 12,5 mg/45 mg filmovertrukken tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 12,5 mg alogliptin og 45 mg pioglitazon.
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.
25 mg/45 mg filmovertrukne tabletter
25 mg/45 mg film-coated tablets
Lever og galdeveje leverfdysunktion, herunder leversvigt ikke kendt
Hepatobiliary disorders hepatic dysfunction including hepatic failure not known
Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerarter.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Incresync.
Incresync 12,5 mg/30 mg filmovertrukne tabletter
Incresync 12.5 mg/30 mg film-coated tablets
Farmakoterapeutisk klassifikation: Antidiabetika; komb.
Pharmacotherapeutic group: Drugs used in diabetes; combinations of oral blood glucose lowering drugs.
Incresync 12,5 mg/45 mg filmovertrukne tabletter
Incresync 12.5 mg/45 mg film-coated tablets
- 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.
- 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.
Det skal du vide, før du begynder at tage Incresync Sådan skal du tage Incresync Bivirkninger
What Incresync is and what it is used for What you need to know before you take Incresync How to take Incresync
Hver 25 mg/30 mg filmovertrukken tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 25 mg alogliptin og 30 mg pioglitazon.
Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Blæk til prægning 12,5 mg/30 mg filmovertrukne tabletter
Printing ink 12.5 mg/30 mg film-coated tablets
Hver tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 12,5 mg alogliptin og 30 mg pioglitazon.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Hver tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 25 mg alogliptin og 45 mg pioglitazon.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
- 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.
- 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.
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.
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.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 25 mg alogliptin (som benzoat) og 45 mg pioglitazon (som hydrochlorid).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Hver tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 12,5 mg alogliptin og 45 mg pioglitazon.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
LÆGEMIDLETS NAVN Incresync 25 mg/45 mg tabletter alogliptin/pioglitazon
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg tablets alogliptin/pioglitazone
Tabel 1: Bivirkninger
Possible side effects
Hver 12,5 mg/30 mg filmovertrukken tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 12,5 mg alogliptin og 30 mg pioglitazon.
Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 12,5 mg alogliptin (som benzoat) og 30 mg pioglitazon (som hydrochlorid).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
LÆGEMIDLETS NAVN Incresync 12,5 mg/45 mg tabletter alogliptin/pioglitazon
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg tablets alogliptin/pioglitazone
Hver tablet indeholder alogliptinbenzoat og pioglitazonhydrochlorid svarende til 25 mg alogliptin og 30 mg pioglitazon.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
LÆGEMIDLETS NAVN Incresync 25 mg/30 mg tabletter alogliptin/pioglitazon
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 12,5 mg alogliptin (som benzoat) og 45 mg pioglitazon (som hydrochlorid).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 25 mg alogliptin (som benzoat) og 30 mg pioglitazon (som hydrochlorid).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
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.
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.
LÆGEMIDLETS NAVN Incresync 12,5 mg/30 mg tabletter alogliptin/pioglitazon
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg tablets alogliptin/pioglitazone
6.1 eller en tidligere alvorlig overfølsomhedsreaktion, herunder anafylaktisk reaktion,
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)
LÆGEMIDLETS NAVN Incresync 25 mg/45 mg filmovertrukne tabletter alogliptin/pioglitazon
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
LÆGEMIDLETS NAVN Incresync 25 mg/30 mg filmovertrukne tabletter alogliptin/pioglitazon
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg film-coated tablets alogliptin/pioglitazone
Behandlingskorrigeret ændring i HbA1c fra baseline
Treatment-corrected change from baseline in HbA1c (%)†
LÆGEMIDLETS NAVN Incresync 12,5 mg/45 mg filmovertrukne tabletter alogliptin/pioglitazon
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg film-coated tablets alogliptin/pioglitazone
LÆGEMIDLETS NAVN Incresync 12,5 mg/30 mg filmovertrukne tabletter alogliptin/pioglitazon
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg film-coated tablets alogliptin/pioglitazone
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
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
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
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
- Øvrige indholdsstoffer: mannitol, mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmelosenatrium, magnesiumstearat, lactosemonohydrat, hypromellose, talkum, titandioxid (E171), rød jernoxid (E172), macrogol 8000, shellac, carnaubavoks og glycerol mono-oleat.
- 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.
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
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
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
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
Filmovertræk 12,5 mg/30 mg filmovertrukne tabletter
12.5 mg/30 mg film-coated tablets
4.4) - Ikke-udredt makroskopisk hæmaturi (se pkt.
Current bladder cancer or a history of bladder cancer (see section 4.4) Uninvestigated macroscopic haematuria (see section 4.4)
- 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.
- 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.
- Øvrige indholdsstoffer: mannitol, mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmelosenatrium, magnesiumstearat, lactosemonohydrat, hypromellose, talkum, titandioxid (E171), rød jernoxid (E172), macrogol 8000, shellac, og sort jernoxid (E172).
- 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).
- 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).
- 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).
Du må ikke tage Incresync, hvis du er gravid eller ammer.
Incresync should not be used during pregnancy or breast-feeding.
• Indlægsseddel
• The package leaflet
Dette sammendrag blev senest ajourført i 06-2016.
This summary was last updated in 06-2016.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vizamyl den 22. august 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Vizamyl on 22 August 2014.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vizamyl.
This is a summary of the European public assessment report (EPAR) for Vizamyl.
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.
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.
Der er udarbejdet en risikostyringsplan for at sikre, at Vizamyl anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Vizamyl is used as safely as possible.
Andre oplysninger om Vizamyl
Other information about Vizamyl
Hvad er Vizamyl, og hvad anvendes det til?
What is Vizamyl and what is it used for?
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.
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.
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).
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).
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vizamyl?
What measures are being taken to ensure the safe and effective use of Vizamyl?
Lægerne skal derfor bruge skanningen sammen med en klinisk vurdering.
Doctors will therefore need to use the scan together with a clinical evaluation.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Vizamyl overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
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.
Det er ikke en praktisk vejledning i, hvordan Vizamyl bør anvendes.
It is not intended to provide practical advice on how to use Vizamyl.
De almindeligste bivirkninger med Vizamyl (der ses hos mellem 1 og 10 ud af hver 100 behandlede) er rødme af huden og forhøjet blodtryk.
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.
Hvilke risici er der forbundet med Vizamyl?
What are the risks associated with Vizamyl?
Hvorfor er Vizamyl blevet godkendt?
Why is Vizamyl approved?
Den type skanning, hvor Vizamyl anvendes, er positronemissionstomografi (PET).
The type of scan used with Vizamyl is called positron-emission tomography (PET).
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.
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.
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.
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.
Dette anses for at være et betydeligt fremskridt i diagnosticering af patienter med hukommelsesproblemer, der vurderes for Alzheimers sygdom og andre typer demens.
This is considered a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia.
Hvis skanningen kun viser lidt eller ingen β-amyloidplak (et negativ skan), er det usandsynligt, at patienten har Alzheimers sygdom.
If few or no β-amyloid plaques are seen in the PET scan (a negative scan), the patient is unlikely to have Alzheimer's disease.
Det betyder, PETskanningerne korrekt identificerede mellem 81 og 93 % af de patienter, der havde nævneværdige mængder plak i hjernen.
This means that the PET scans correctly identified as positive between 81-93% of the patients who had significant amounts of plaques in their brain.
Vizamyl afgiver en meget lille mængde stråling, som medfører en minimal risiko for kræft eller arvelige defekter.
Vizamyl delivers a very low amount of radiation which poses a very low risk of cancer or any hereditary abnormalities.
Hvis du ønsker yderligere oplysninger om behandling med Vizamyl, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Vizamyl, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Patienten bør drøfte resultaterne af PETskanningen med lægen.
Patients should discuss the results of their PET scan with their doctor.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vizamyl, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vizamyl, including the appropriate precautions to be followed by healthcare professionals and patients.
En positiv skanning er dog i sig selv ikke nok til at stille diagnosen hos patienter med hukommelsesproblemer, da plak forekommer både hos patienter med forskellige typer demens og hos ældre uden symptomer.
However, a positive scan on its own is not sufficient to make a diagnosis in patients with memory problems, as plaques may be seen in patients with different types of dementias as well as in older people with no symptoms.
Vizamyl fås kun på recept, og PET-skanninger med Vizamyl bør kun rekvireres af læger med erfaring i klinisk behandling af patienter med sygdomme som Alzheimers sygdom og andre former for demens.
Vizamyl can only be obtained with a prescription, and PET scans with Vizamyl should only be requested by doctors experienced in the clinical management of patients with diseases such as Alzheimer's disease and other dementias.
Desuden er det ikke fastslået, i hvilket omfang Vizamyl er egnet til at forudsige forløbet af Alzheimers sygdom hos patienter med hukommelsesproblemer eller til at overvåge behandlingens gavnlige virkning for patienterne.
In addition, the usefulness of Vizamyl in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Det aktive stof i Vizamyl, flutemetamol (18F), er et radioaktivt lægemiddel, der afgiver små mængder stråling og virker ved at bindes til β-amyloidplak i hjernen.
The active substance in Vizamyl, flutemetamol (18F), is a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Den afgivne stråling registreres på PETskanningen, så lægerne kan se, om der er nævneværdige mængder plak til stede.
The radiation it emits can be detected on the PET scan, enabling doctors to see whether or not significant amount of plaques are present.
Når skanningen er udført, vurderes billedet af speciallæger i nuklearmedicin, der er særlig oplært i at tolke PET-skanninger med Vizamyl.
After the image is obtained, it is read by nuclear medicine physicians specifically trained in interpreting PET scans with Vizamyl.
Udvalget bemærkede, at PET-skanning med Vizamyl har høj følsomhed og specificitet til påvisning af nævneværdige mængder β-amyloidplak i hjernen, og at skanningen nøje afspejler obduktionsresultaterne.
The Committee noted that PET scans with Vizamyl have a high sensitivity and specificity for detecting a significant amount of beta-amyloid plaques in the brain, and that scans closely reflect what was seen at autopsy.
Den fuldstændige liste over indberettede bivirkninger og begrænsninger med Vizamyl fremgår af indlægssedlen.
For the full list of all side effects and restrictions reported with Vizamyl, see the package leaflet.
Hvis du ønsker praktisk vejledning om anvendelsen af Vizamyl, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Vizamyl, patients should read the package leaflet or contact their doctor or pharmacist.
Vizamyl er et lægemiddel, der indeholder små mængder af det radioaktive stof flutemetamol (18F); det bruges kun til undersøgelse af patienter (diagnostisk brug).
Vizamyl is a radiopharmaceutical (a medicine containing small amounts of a radioactive substance) that contains the active substance flutemetamol (18F); it is for diagnostic use only.