natgillin/translations-raw huggingface dataset:
98 x 1 filmovertrukne tabletter 100 filmovertrukne tabletter 100 x 1 filmovertrukne tabletter 112 filmovertrukne tabletter
98 x 1 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets 112 film-coated tablets
Du bør tage tabletterne regelmæssigt hver dag på samme tidspunkt af dagen for at opnå størst mulig virkning af tabletterne.
To benefit from your medicine you should take it regularly every day at the same time of the day.
Hos patienter med svært nedsat nyrefunktion (kreatininclearance 5 - 29 ml/min) er daglig dosis 10 mg pr. dag.
In patients with severe renal impairment (creatinine clearance 5 - 29 ml/min) daily dose should be 10 mg per day.
INFORMATION I BRAILLESKRIFT Memantine Mylan 10 mg
INFORMATION IN BRAILLE Memantine Mylan 10 mg
Den normale startdosis er en halv 10 mg tablet en gang dagligt (5 mg) i den første uge.
The usual starting dose is half a 10 mg tablet once a day (5 mg) for the first week.
Fra og med den fjerde uge er den normale dosis en 20 mg tabletter en gang dagligt (20 mg).
From the fourth week on, the usual dose is one 20 mg tablet once a day (20 mg).
INFORMATION I BRAILLESKRIFT Memantine Mylan 20 mg
INFORMATION IN BRAILLE Memantine Mylan 20 mg
I en væsentlig monoterapiundersøgelse med memantin til behandling af mild til moderat Alzheimers sygdom (med en samlet MMSE score ved baseline på 10-22) indgik 403 patienter.
A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Pakningsstørrelserne 28 x 1, 56 x 1, 98 x 1 og 100 x 1 filmovertrukne tabletter fås i enkeltdosisblister.
The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blisters.
Der sås ingen relevante interaktioner mellem de aktive stoffer memantin og glyburid/metformin eller donepezil i enkeltdosis farmakokinetiske (PK)-studier hos yngre, raske forsøgspersoner.
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance active substance interaction of memantine with glyburide/metformin or donepezil was observed.
en halv tablet á 10 mg uge 2
half a 10 mg tablet week 2
Polydextrose (E1200), titandioxid (E171), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), gul jernoxid (E172), macrogol 400 (E1521), macrogol 8000, indigo carmin aluminium lake (E132) og rød jernoxid (E172), som alle finde i tablettens filmovertræk.
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc and colloidal anyhdrous silica, all in the tablet core; polydextrose (E1200), titanium dioxide (E171), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide yellow (E172), macrogol 400 (E1521), macrogol 8000, indigo carmine aluminium lake (E132) and iron oxide red (E172), all in the tablet coating.
Memantine Mylan bør indtages gennem munden én gang pr. dag.
Memantine Mylan should be administered orally once a day.
56 x 1 filmovertrukne tabletter 60 filmovertrukne tabletter
56 x 1 film-coated tablets 60 film-coated tablets
28 x 1 filmovertrukne tabletter 30 filmovertrukne tabletter
28 x 1 film-coated tablets 30 film-coated tablets
Administration af Memantine Mylan til patienter med svært nedsat leverfunktion frarådes.
Administration of Memantine Mylan is not recommended in patients with severe hepatic impairment.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2013
halvanden tablet á 10 mg 4. uge og derefter en tablet á 20 mg en gang dagligt
one and a half 10 mg tablets week 4 and beyond one 20 mg tablet once a day
Fra og med den fjerde uge er den normale dosis 2 10 mg tabletter en gang dagligt (1 x 20 mg).
From the fourth week on, the usual dose is two 10 mg tablets once a day (20 mg).
Uge 2 (dag 8-14): Patienten bør tage én 10 mg filmovertrukket tablet (10 mg) dagligt i 7 dage.
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Uge 1 (dag 1-7): Patienten bør tage en halv 10 mg filmovertrukket tablet (5 mg) dagligt i 7 dage.
Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), rød jernoxid (E172), macrogol 400 (E1521), macrogol 8000, som alle finde i tablettens filmovertræk.
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc and colloidal anyhdrous silica, all in the tablet core; polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide red (E172), macrogol 400 (E1521), macrogol 8000, all in the tablet coating.
halvanden tablet á 10 mg 4. uge og derefter to tabletter á 10 mg én gang dagligt
one and a half 10 mg tablets week 4 and beyond two 10 mg tablets once a day
Uge 3 (dag 15-21): Patienten bør tage halvanden 10 mg filmovertrukket tablet (15 mg) dagligt i 7 dage.
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablets (15 mg) per day for 7 days.
Bliv ved med at tage Memantine Mylan, så længe du har gavn af det. Din læge bør regelmæssigt vurdere din behandling.
Continue to take Memantine Mylan as long as it is of benefit to you.
Det skal du vide, før du begynder at tage Memantine Mylan Sådan skal du tage Memantine Mylan Bivirkninger
What Memantine Mylan is and what it is used for What you need to know before you take Memantine Mylan How to take Memantine Mylan Possible side effects
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 10 mg memantinhydrochlorid svarende til 8,31 mg memantin.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
En rød, filmovertrukket, oval, bikonveks tablet med skrå kanter, præget med “ME” på den ene side af tabletten og “20” på den anden side af tabletten.
A red film-coated, oval, biconvex, bevelled edge tablet debossed with “ME” on one side of the tablet and “20” on the other side.
Hver filmovertrukket tablet indeholder 20 mg memantinhydrochlorid svarende til 16,62 mg memantin.
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Du bør også informere din læge, hvis du lider af tilstande med renal tubulær acidose (RTA, overskud af syredannende stoffer i blodet på grund af nedsat nyrefunktion) eller alvorlige infektioner i urinvejene (som urinen udskilles igennem).
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
ANGIVELSE AF AKTIVT STOF Hver filmovertrukket tablet indeholder 20 mg memantinhydrochlorid svarende til 16,62 mg memantin.
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
monoterapiundersøgelser og undersøgelser med patienter behandlet med fastdosis acetylkolinesterasehæmmere) viste, at memantin havde statistisk signifikant effekt på de kognitive, globale og funktionelle domæner.
A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Memantine Mylan 10 mg filmovertrukne tabletter
Memantine Mylan 10 mg film-coated tablets
• Betændelse i bugspytkirtlen, leverbetændelse (hepatitis) og psykotiske reaktioner
• Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
By reporting side effects you can help provide more information on the safety of this medicine.
Hver filmovertrukket tablet indeholder 10 mg memantinhydrochlorid svarende til 8,31 mg memantin.
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Memantine Mylan 20 mg filmovertrukne tabletter
Memantine Mylan 20 mg film-coated tablets
En mørkegul, filmovertrukket, bikonveks tablet, som er indsnævret mod midten og mærket med “ME” på venstre side af delekærven og “10” på højre side af delekærven på den ene side af tabletten og med en delekærv på den anden side af tabletten.
A dark yellow film-coated, tapered oblong shaped, biconvex tablet debossed with “ME” on the left of the score and “10” on the right of the score on one side of the tablet and a score on the other side.
EU/1/13/827/033 98 x 1 filmovertrukne tabletter EU/1/13/827/034 100 filmovertrukne tabletter EU/1/13/827/035 100 x 1 filmovertrukne tabletter EU/1/13/827/036 112 filmovertrukne tabletter
EU/1/13/827/033 98 x 1 film-coated tablets EU/1/13/827/034 100 film-coated tablets EU/1/13/827/035 100 x 1 film-coated tablets EU/1/13/827/036 112 film-coated tablets
ANGIVELSE AF AKTIVT STOF Hver filmovertrukket tablet indeholder 10 mg memantinhydrochlorid svarende til 8,31 mg memantin.
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
EU/1/13/827/015 98 x 1 filmovertrukne tabletter EU/1/13/827/016 100 filmovertrukne tabletter EU/1/13/827/017 100 x 1 filmovertrukne tabletter EU/1/13/827/018 112 filmovertrukne tabletter
EU/1/13/827/015 98 x 1 film-coated tablets EU/1/13/827/016 100 film-coated tablets EU/1/13/827/017 100 x 1 film-coated tablets EU/1/13/827/018 112 film-coated tablets
Yderligere for 10 mg filmovertrukne tabletter: Titandioxid (E171)
Titanium dioxide (E171)
Tabletkerne for 10/20 mg filmovertrukne tabletter: Cellulose.
Tablet cores for 10/20 mg film-coated tablets: Cellulose, microcrystalline Croscarmellose sodium Magnesium stearate
Memantine Mylan 10 mg filmovertrukne tabletter Memantine Mylan 20 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT Memantine Mylan 10 mg film-coated tablets Memantine Mylan 20 mg film-coated tablets
Hypromellose 50cP (E464) Macrogol 400 (E1521)
Macrogol 400 (E1521)
EU/1/13/827/007 42 filmovertrukne tabletter
EU/1/13/827/007 42 film-coated tablets
LÆGEMIDLETS NAVN Memantine Mylan 20 mg filmovertrukne tabletter memantinhydrochlorid
NAME OF THE MEDICINAL PRODUCT Memantine Mylan 20 mg film-coated tablets memantine hydrochloride
LÆGEMIDLETS NAVN Memantine Mylan 10 mg filmovertrukne tabletter memantinhydrochlorid
NAME OF THE MEDICINAL PRODUCT Memantine Mylan 10 mg film-coated tablets memantine hydrochloride
Der sås ingen relevant effekt af memantin på galantamins farmakokinetik i en klinisk undersøgelse med yngre, raske forsøgspersoner.
In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
EU/1/13/827/025 42 filmovertrukne tabletter
EU/1/13/827/025 42 film-coated tablets
EU/1/13/827/005 28 x 1 filmovertrukne tabletter EU/1/13/827/006 30 filmovertrukne tabletter
EU/1/13/827/005 28 x 1 film-coated tablets EU/1/13/827/006 30 film-coated tablets
EU/1/13/827/022 28 filmovertrukne tabletter
EU/1/13/827/022 28 film-coated tablets
Memantine Mylan 10 mg filmovertrukne tabletter memantinhydrochlorid
Memantine Mylan 10 mg film-coated tablets memantine hydrochloride
EU/1/13/827/032 98 filmovertrukne tabletter
EU/1/13/827/032 98 film-coated tablets
EU/1/13/827/023 28 x 1 filmovertrukne tabletter EU/1/13/827/024 30 filmovertrukne tabletter
EU/1/13/827/023 28 x 1 film-coated tablets EU/1/13/827/024 30 film-coated tablets
Memantine Mylan 20 mg filmovertrukne tabletter memantinhydrochlorid
Memantine Mylan 20 mg film-coated tablets memantine hydrochloride
EU/1/13/827/030 70 filmovertrukne tabletter
EU/1/13/827/030 70 film-coated tablets
EU/1/13/827/009 56 filmovertrukne tabletter
EU/1/13/827/009 56 film-coated tablets
EU/1/13/827/019 7 filmovertrukne tabletter
EU/1/13/827/019 7 film-coated tablets
EU/1/13/827/010 56 x 1 filmovertrukne tabletter EU/1/13/827/011 60 filmovertrukne tabletter
EU/1/13/827/010 56 x 1 film-coated tablets EU/1/13/827/011 60 film-coated tablets
EU/1/13/827/020 10 filmovertrukne tabletter
EU/1/13/827/020 10 film-coated tablets
EU/1/13/827/002 10 filmovertrukne tabletter
EU/1/13/827/002 10 film-coated tablets
EU/1/13/827/008 50 filmovertrukne tabletter
EU/1/13/827/008 50 film-coated tablets
EU/1/13/827/021 14 filmovertrukne tabletter
EU/1/13/827/021 14 film-coated tablets
Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
You can also report side effects directly via the national reporting system listed in Appendix V*.
EU/1/13/827/027 56 filmovertrukne tabletter
EU/1/13/827/027 56 film-coated tablets
En rød, filmovertrukket, oval, bikonveks tablet med skrå kanter, mærket med “ME” på den ene side af tabletten og “20” på den anden side af tabletten.
What Memantine Mylan looks like and contents of the pack A red film-coated, oval, biconvex, beveled edge tablet marked with “ME” on one side of the tablet and “20” on the other side.
EU/1/13/827/004 28 filmovertrukne tabletter
EU/1/13/827/004 28 film-coated tablets
EU/1/13/827/028 56 x 1 filmovertrukne tabletter EU/1/13/827/029 60 filmovertrukne tabletter
EU/1/13/827/028 56 x 1 film-coated tablets EU/1/13/827/029 60 film-coated tablets
EU/1/13/827/026 50 filmovertrukne tabletter
EU/1/13/827/026 50 film-coated tablets
EU/1/13/827/014 98 filmovertrukne tabletter
EU/1/13/827/014 98 film-coated tablets
EU/1/13/827/031 84 filmovertrukne tabletter
EU/1/13/827/031 84 film-coated tablets
EU/1/13/827/001 7 filmovertrukne tabletter
EU/1/13/827/001 7 film-coated tablets
EU/1/13/827/012 70 filmovertrukne tabletter
EU/1/13/827/012 70 film-coated tablets
EU/1/13/827/003 14 filmovertrukne tabletter
EU/1/13/827/003 14 film-coated tablets
EU/1/13/827/013 84 filmovertrukne tabletter
EU/1/13/827/013 84 film-coated tablets
PecFent fik en markedsføringstilladelse med gyldighed i hele EU den 31. august 2010.
PecFent received a marketing authorisation valid throughout the EU on 31 August 2010.
Hvad er PecFent, og hvad anvendes det til?
What is PecFent and what is it used for?
Det er et velkendt stof, der har været anvendt i mange år til at kontrollere smerter.
It is a well-known substance, which has been used to control pain for many years.
Det betyder, at det svarer til en række "referencelægemidler", der indeholder samme aktive stof, men gives på en anden måde.
This means that it is similar to ‘reference medicines' containing the same active substance, but given in a different way.
Yderligere information om PecFent findes på agenturets websted under: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Further information on PecFent can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Doserne bør gives enten som én eller to spray af samme styrke.
The doses should be given as either one spray or two sprays of the same strength.
Patienten bør overvåges omhyggeligt, mens dosis øges.
The patient should be monitored carefully while the dose is increased.
Den gennemsnitlige reduktion af smerter i løbet af de første 30 minutter efter brug var 6,6 point hos patienter, der fik PecFent, sammenholdt med 4,5 point blandt dem, der fik placebo.
The average reduction in pain during the first 30 minutes after use was 6.6 points in patients receiving PecFent compared with 4.5 in those receiving placebo.
PecFent er et "hybridt lægemiddel".
PecFent is a ‘hybrid medicine'.
Patienterne bør overvåges nøje for disse bivirkninger.
Patients should be closely monitored for these side effects.
Typiske opioid-bivirkninger må forventes med PecFent; de vil ofte ophøre eller blive mindre intense ved fortsat brug af lægemidlet.
Typical opioid side effects are to be expected with PecFent; often these will stop or become less intense with continued use of the medicine.
Som for alle lægemidler bliver data vedrørende brug af PecFent løbende overvåget.
As for all medicines, data on the use of PecFent are continuously monitored.
Da PecFent er et hybridt lægemiddel, fremlagde ansøgeren oplysninger om referencelægemidlerne i tillæg til resultaterne af sine egne studier.
Because PecFent is a hybrid medicine, the applicant presented data on the reference medicines in addition to results from its own studies.
Patienterne bør ikke tage mere end fire doser om dagen, og der bør gå mindst fire timer mellem hver dosis.
Patients should not take more than four doses a day and should leave a gap of at least four hours between treating each episode of pain.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af PecFent?
What measures are being taken to ensure the safe and effective use of PecFent?
En oversigt over PecFent, og hvorfor det er godkendt i EU
An overview of PecFent and why it is authorised in the EU
Hvorfor er PecFent godkendt i EU?
Why is PecFent authorised in the EU?
Andre oplysninger om PecFent
Other information about PecFent:
Bivirkninger indberettet for PecFent vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with PecFent are carefully evaluated and any necessary action taken to protect patients.
Startdosen bør altid være 100 mikrogram (én spray i ét næsebor).
The first trial dose should always be 100 micrograms (one spray into one nostril).
Det primære mål for virkning var ændringen i sværhedsgraden af smerter som bedømt af patienterne på en skala fra 0 til 10.
The main measure of effectiveness was the change in the severity of pain measured by the patients ranking their pain on a scale from 0 to 10.
Lægen bør være opmærksom på, at PecFent kan misbruges.
The doctor should keep in mind the potential for PecFent to be abused.
Den virksomhed, der markedsfører PecFent, skal udarbejde informationsmateriale i hver EUmedlemsstat for at sikre, at patienter, læger og apotekspersonale er klar over, hvordan PecFent bør anvendes, hvad risikoen for utilsigtet eksponering for fentanyl er, og hvordan lægemidlet bør bortskaffes.
The company that markets PecFent will provide educational materials in each EU Member State to make sure that patients, doctors and pharmacists are aware of how PecFent should be used, the risk of accidental exposure to fentanyl and how to dispose of the medicine.
For mere information om brug af PecFent, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using PecFent, see the package leaflet or contact your doctor or pharmacist.
Hvilke risici er der forbundet med PecFent?
What are the risks associated with PecFent?
Når en patient starter med at tage PecFent, er lægen nødt til at beregne, hvilken dosis der giver tilstrækkelig smertelindring med så få bivirkninger som muligt.
When a patient starts to take PecFent the doctor will need to work out the appropriate dose that will provide adequate pain relief with as few side effects as possible.
PecFent fås som en næsespray (100 og 400 mikrogram pr. spray) og kan kun fås på en særlig recept.
PecFent is available as a nasal spray (100 and 400 micrograms per spray) and can only be obtained by ‘special' prescription.
De alvorligste bivirkninger er respirationsdepression (hæmning af vejrtrækningen), kredsløbsdepression (langsom hjerterytme), for lavt blodtryk og shock (markant fald i blodtrykket).
The most serious of these side effects are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure).
I dette studie rapporterede patienterne, at de var tilfredse eller meget tilfredse med PecFent-behandlingen i ca. 90 % af tilfældene af gennembrudssmerter.
In this study, patients reported that they were ‘satisfied' or ‘very satisfied' with PecFent treatment for around 90% of breakthrough pain episodes.
Mens referencelægemidlerne Effentora (bukkaltabletter) og Actiq (sugetabletter) tages gennem munden, gives PecFent som en spray i næsen.
While the reference medicines Effentora (buccal tablets) and Actiq (lozenges) are taken by mouth, PecFent is given as a spray into the nose.
Det aktive stof i PecFent, fentanyl, er et opioid.
The active substance in PecFent, fentanyl, is an opioid.
PecFent indeholder det aktive stof fentanyl.
PecFent contains the active substance fentanyl.
I et hovedstudie blev det påvist, at PecFent er mere effektivt end placebo (ikke-aktivt stof) til at behandle gennembrudssmerter hos 83 voksne kræftpatienter, som blev behandlet med opioider.
In one main study, PecFent was shown to be more effective than placebo (a dummy treatment) at treating breakthrough cancer pain in 83 adults who were being treated with opioids.
PecFent bør ikke anvendes hos patienter, der ikke allerede tager opioider for at holde smerterne under kontrol, der har svær respirationsdepression (hæmning af vejrtrækningen) eller som har en svær obstruktiv lungesygdom (sygdom, der i alvorlig grad hæmmer vejrtrækningen).
PecFent must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing).
Behandling med PecFent bør iværksættes og gennemføres under overvågning af en læge, der har erfaring i opioidbehandling af kræftpatienter.
Treatment with PecFent should be started by and remain under the supervision of a doctor who has experience in managing opioid treatment in cancer patients.
Det må ikke anvendes til behandling af kortvarige smerter, som ikke er gennembrudssmerter.
It must not be used to treat short-term pain other than breakthrough pain.
Hvordan anvendes PecFent?
How is PecFent used?
Når patienten sprayer PecFent ind i næsen, optages fentanyl-dosen hurtigt i blodbanen gennem blodkarrene i næsen.
When the patient sprays PecFent into the nose, a dose of fentanyl is rapidly absorbed into the blood stream through the blood vessels in the nose.
Et andet studie målte patienternes tilfredshed med PecFent og i, hvor høj grad de fandt det let og smart at bruge.
An additional study measured the ‘acceptability' of PecFent by the patients, rating how satisfied they were with PecFent, and how easy and convenient they found it to use.
Det Europæiske Lægemiddelagentur bemærkede, at der var behov for et hurtigvirkende smertestillende middel mod gennembrudssmerter hos kræftpatienter.
The European Medicines Agency noted that there was a need for fast-acting pain medicines for breakthrough pain in patients with cancer.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved PecFent opvejer risiciene, og det kan godkendes til anvendelse i EU.
Based on available data, the Agency concluded that PecFent's benefits are greater than its risks and it can be authorised for use in the EU.
PecFent er et lægemiddel, der anvendes til behandling af gennembrudssmerter hos voksne patienter med kræft.
PecFent is a medicine used to treat breakthrough pain in adult patients with cancer.