natgillin/translations-raw huggingface dataset:
Alkalisering af urin kan skyldes drastiske ændringer i kosten, f.eks. fra en kødholdig til en vegetarisk kost eller en kraftig indtagelse af alkaliserende gastriske buffere. 
Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers.
Hos patienter behandlet med memantin sås statistisk signifikant bedre effekt på de primære effektmål end hos patienter behandlet med placebo: Alzheimer´s disease assessment scale (ADAS-cog) (p=0,003) og CIBIC-plus (p=0,004) i uge 24 (Last observation carried forward (LOCF)). 
Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
Fertilitet Der ses ingen bivirkninger af memantin i forbindelse med mænds og kvinders fertilitet. 
Fertility No adverse reactions of memantine were noted on male and female fertility.
Memantine Mylan indeholder det aktive stof memantin. 
Memantine Mylan contains the active substance memantine.
• Træthed, svampeinfektioner, forvirring, hallucinationer, opkastning, unormal gang, hjertesvigt og blodprop i en blodåre (vene) (trombose/tromboembolisme) Meget sjælden (kan påvirke op til 1 ud af 10.000 patienter): 
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism) Very rare (may affect up to 1 in 10,000 people):
Følgende bivirkninger (i nedenstående tabel) er indrapporteret i forbindelse med kliniske studier med memantin og efter markedsføring. 
The following adverse reactions listed in the Table below have been accumulated in clinical studies with memantine and since its introduction in the market.
I en anden monoterapiundersøgelse af mild til moderat Alzheimers sygdom blev i alt 470 patienter randomiseret (samlet MMSE score ved baseline 11-23). 
In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
Amning Kvinder, der tager Memantine Mylan, bør ikke amme. 
Breast-feeding Women taking Memantine Mylan should not breast-feed.
Der foreligger ingen tilgængelige data om brug af memantin hos patienter med svært nedsat leverfunktion. 
No data on the use of memantine in patients with severe hepatic impairment are available.
Brug af anden medicin sammen med Memantine Mylan Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig. 
Other medicines and Memantine Mylan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
en tablet á 10 mg uge 3 
one 10 mg tablet week 3
Den anbefalede dosis af Memantine Mylan til voksne og ældre er 20 mg én gang dagligt. 
The recommended dose of Memantine Mylan for adults and older people is 20 mg once a day.
• Hovedpine, søvnighed, forstoppelse, forhøjede værdier ved leverfunktionsprøver, svimmelhed, balanceforstyrrelser, stakåndethed, forhøjet blodtryk og overfølsomhed over for lægemidlet. 
• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Fra 4. uge: Patienten bør tage to 10 mg filmovertrukne tabletter (20 mg) eller én 20 mg filmovertrukket tablet dagligt. 
From Week 4 on: The patient should take two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet per day.
Denne øges til en 10 mg tablet en gang dagligt (10 mg) i den anden uge og til 1½ 10 mg tablet en gang dagligt i den tredje uge. 
This is increased to one 10 mg tablet once a day (10 mg) in the second week and to 1 and a half 10 mg tablets once a day in the third week.
Andre tabletstyrker er tilgængelige til optitrering. 
For up-titration other tablet strengths are available.
Hos patienter med let nedsat nyrefunktion (kreatininclearance 50 - 80 ml/min) er dosisjustering ikke nødvendig. 
In patients with mildly impaired renal function (creatinine clearance 50 - 80 ml/min) no dose adjustment is required.
Blisterstrip af klar PVC-PVdC-film med perforerbar aluminiumsfolie i pakningsstørrelser på 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 eller 112 filmovertrukne tabletter. 
Clear PVC-PVdC film with push through aluminium foil lidding blisters in pack sizes of 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets.
Graviditet Memantin frarådes til gravide kvinder. 
Pregnancy The use of memantine in pregnant women is not recommended.
Memantine Mylan filmovertrukne tabletter fås i blisterstrip i pakningsstørrelser på 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 eller 112 filmovertrukne tabletter. 
Memantine Mylan film-coated tablets are available in blister packs of 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets.
Hos patienter med moderat nedsat nyrefunktion (kreatininclearance 30 - 49 ml/min) er daglig dosis 10 mg pr. dag. 
In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg per day.
Det skal du vide, før du begynder at tage Memantine Mylan 
What you need to know before you take Memantine Mylan
BATCHNUMMER Batchnr 
BATCH NUMBER Lot
Pakningsstørrelserne 28 x 1, 56 x 1, 98 x 1 og 100 x 1 filmovertrukne tabletter fås i perforeret enkeltdosisblister af klar PVC-PVdC-film med perforerbar aluminiumsfolie. 
The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in clear PVC-PVdC film with push through aluminium foil lidding perforated unit dose blisters.
I en væsentlig monoterapiundersøgelse med en patientpopulation, der led af moderat til svær Alzheimers sygdom (med en samlet mini mental state examination (MMSE) score ved baseline på 3-14), indgik i alt 252 ambulante patienter. 
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Dosering Den anbefalede dosis af Memantine Mylan til voksne og ældrer er 20 mg én gang dagligt. 
Dosage The recommended dose of Memantine Mylan for adults and older people is 20 mg once a day.
Sådan skal du tage Memantine Mylan 
How to take Memantine Mylan
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.