natgillin/translations-raw huggingface dataset:
Hvis De er på natrium- eller saltfattig diæt, skal De tage hensyn hertil og spørge Deres læge til råds. 
You should take this into consideration if you are on a controlled sodium diet and seek advice from your doctor.
diarré, angst, kulderystelser, tremor og svedtendens), rystelser, faldtendens, kulderystelser 
vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shaking, falls, chills
Hvis De oplever en eller flere af disse bivirkninger, bør De kontakte Deres læge. 
If you notice any of these, contact your doctor.
Mavesmerter Gastroøsofageal reflukssygdom Maveubehag Dyspepsi Tandpine 
Constipation Stomatitis Dry mouth Diarrhoea Abdominal pain Gastrooesophageal reflux disease Stomach discomfort Dyspepsia Toothache
1/10.000 til < 1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
<1/1,000), not known (cannot be estimated from the available data); within each frequency group, undesirable effects are presented in order of decreasing seriousness:
• Vejledning i ordination af EFFENTORA 
• EFFENTORA prescribing guide
Natrium- eller saltfattig diæt 
Controlled sodium diet
• Træk blister-enhedens bagside af for at blotlægge tabletten. 
• Peel the blister backing to expose the tablet.
Fentanyl bør ikke anvendes af ammende kvinder, og amning bør ikke genoptages før mindst 5 dage efter den sidste dosis fentanyl. 
Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breastfeeding should not be restarted until at least 5 days after the last administration of fentanyl.
Effentora må ikke ordineres til patienter, der ikke er i behandling med opioider for smerter hele døgnet 
Effentora must not be prescribed in patients without around-the-clock opioid pain medication
Peak plasma-koncentrationer, målt med venøse blodprøver, opnås sædvanligvis inden for en time efter oromukosal administration. 
The absorption profile of Effentora is largely the result of an initial rapid absorption from the buccal mucosa, with peak plasma concentrations following venous sampling generally attained within an hour after oromucosal administration.
Nedsat blodpladetal Øget hjertefrekvens Nedsat hæmatokrit Nedsat hæmoglobin 
Platelet count decreased Heart rate increased Haematocrit decreased Haemoglobin decreased
Reaktioner ved applikationsstedet herunder blødning, smerte, sår, irritation, paræstesi, anæstesi, erytem, ødem, hævelse og blærer 
Application site reactions including bleeding, pain, ulcer, irritation, paraesthesia, anaesthesia, erythema, oedema, swelling and vesicles
• følelse af at være opstemt, nervøs, unormal, anspændt eller langsom; se eller høre ting, der faktisk slet ikke er der (hallucinationer), nedsat bevidsthed, ændring i den mentale tilstand, 
• feeling elated, nervous, abnormal, jittery or slow; seeing or hearing things that are not really there (hallucinations), reduced consciousness, change in mental state, dependence (reliance on the medicine, addiction), disorientation, lack of concentration, loss of balance, vertigo, problem with speaking, ringing in the ear, ear discomfort
Stoffer, der kan potensere de suppressive virkninger på CNS Samtidig administration af fentanyl og andre CNS-depressiva, herunder andre opioider, sedativa eller hypnotika (herunder benzodiazepiner), medikamenter til generel anæstesi, fenotiaziner, beroligende midler, skeletmuskel-relaxantia, sederende antihistaminer og alkohol kan potensere yderligere suppressive virkninger, hvilket kan resultere i død (se pkt. 
Co-administration of fentanyl with other central nervous system depressants, including other opioids, sedatives or hypnotics, (including benzodiazepines), general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol can produce additive depressant effects which may result in a fatal outcome (see section 4.4).
Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 20 mg natrium. 
Excipient with known effect: Each tablet contains 20 mg of sodium.
Ved intravenøs administration er det dog påvist, at clearance af fentanyl ændres på grund af ændringer i den metaboliske clearance og i plasma proteiner hos patienter med nedsat levereller nyrefunktion. 
The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated, however, when administered intravenously the clearance of fentanyl has been shown to be altered in hepatic and renal impairment due to alterations in metabolic clearance and plasma proteins.
Deres behov for smertestillende medicin kan ændre sig i løbet af behandlingen. 
In the further course of treatment your requirement for analgesic therapy may change.
Fentanyl metaboliseres hovedsagelig via det humane CYP3A4-isoenzymsystem (CYP3A4). 
Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Effentora is given concurrently with agents that affect CYP3A4 activity.
• De bruger antidepressiv eller antipsykotisk medicin (selektive serotoningenoptagelseshæmmere [SSRI'er], serotonin-noradrenalingenoptagelseshæmmere [SNRI'er], monoaminoxidasehæmmere (MAO-hæmmere); se pkt. 
• You use antidepressants or antipsychotics (selective serotonin reuptake inhibitors [SSRIs],
Hver Effentora-tablet af 200 mikrogram, 400 mikrogram, 600 mikrogram og 800 mikrogram indeholder 20 mg natrium. 
Each tablet of Effentora 200 micrograms, Effentora 400 micrograms, Effentora 600 micrograms and Effentora 800 micrograms contains 20 mg of sodium.
Bradykardi 
Tachycardia Bradycardia
Samtlige patienter tog endvidere opioider såsom morfin som depottabletter eller transdermal fentanyl for deres vedvarende smerte. 
The clinical studies of Effentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Nogle forandringer, der kan observeres, omfatter en stigning i serumprolactin og et fald plasmakortisol og plasmatestosteron.Kliniske tegn og symptomer kan være manifestationer fra disse hormonale forandringer (se også pkt. 
Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.
• træthed 
• malaise
Depression Angst Konfusion Søvnløshed 
Depression Anxiety Confusional state
Hvis der optræder irritation i gummen/kinden, anbefales det at finde en ny placering til tabletten. 
In case of buccal mucosa irritation, a change in tablet placement within the buccal cavity should be recommended.
Undervisningsmaterialet til læger skal bestå af fire dele: 
The educational material for healthcare professionals shall consist of four items: • Opioid prescribing guide
Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 10 mg natrium. 
Excipient with known effect: Each tablet contains 10 mg of sodium.
Under titreringen bør patienterne vente mindst fire timer, inden de behandler et nyt anfald af gennembrudssmerter med Effentora. 
Patients should wait at least 4 hours before treating another BTP episode with Effentora during titration.
2 under ”Brug af anden medicin sammen med Effentora”). 
• You use benzodiazepines (see section 2 under “Other medicines and Effentora”).
Fotopsi 
Photopsia
Sådan skal de tage Effentora 
How to use Effentora
Overfølsomhed* 
Hypersensitivit y*
• kvalme, opkastning 
• feeling nauseous, vomiting
Bradyarytmi 
Bradyarrhythmias
Synsforstyrrelse Okular hyperæmi Sløret syn Nedsat syn 
Visual disturbance Ocular hyperaemia Blurred vision Visual acuity reduced
Under vedligeholdelsesbehandlingen bør patienten vente mindst fire timer, inden et nyt anfald af gennembrudssmerter behandles med Effentora. 
Patients should wait at least 4 hours before treating another BTP episode with Effentora during maintenance therapy.
Glossodyni Blister på tungen Smerte i gummen Sår på tungen Lidelse i tungen Øsofagitis Sprukne læber Tandlidelse 
Mouth ulceration Oral hypoaesthesia Oral discomfort Oral mucosal discolouration Oral soft tissue disorder Glossodynia Tongue blistering Gingival pain Tongue ulceration Tongue disorder Oesophagitis Chapped lips Tooth disorder
• hvis De lider af andre kortvarige smerter end gennembrudssmerter, såsom smerter fra skader eller efter en operation, hovedpine eller migræne. 
• If you suffer from short-term pain other than breakthrough pain
Samtidig brug af Effentora og stærke CYP3A4-hæmmere (f.eks. ritonavir, ketoconazol, itraconazol, troleandomycin, clarithromycin og nelfinavir) eller moderate CYP3A4-hæmmere (f.eks. amprenavir, aprepitant, diltiazem, erythromycin, fluconazol, fosamprenavir, grapefrugtjuice og verapamil) kan resultere i forhøjede plasmakoncentrationer af fentanyl, hvilket potentielt kan forårsage alvorlige bivirkninger herunder dødelig respirationsdepression. 
amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression.
Brug ikke andre fentanylpræparater tidligere ordineret for Deres gennembrudssmerter, mens De bliver behandlet med Effentora. 
Whilst you are being treated with Effentora, do not use other fentanyl treatments previously prescribed for your breakthrough pain.
Serotonerge stoffer: 
Serotoninergic agents
Effentora 400 mikrogram bukkaltabletter EU/1/08/441/005-006 
Effentora 400 micrograms buccal tablets EU/1/08/441/005-006
Stofafhængighed Stofmisbrug Delirium 
Drug dependence (addiction)*, Drug abuse, Delirium
Muskeltrækninger 
Oral pustule
• ét eller flere af følgende problemer i munden: sår, følelsesløshed, ubehag, unormal farve, 
• one or more of the following problems in the mouth: ulcer, loss of sensation, discomfort, unusual colour, soft tissue disorder, tongue disorder, painful or blistered or ulcerated tongue, gum pain, chapped lips, tooth disorder
Effentora 200 mikrogram bukkaltabletter EU/1/08/441/003-004 
Effentora 200 micrograms buccal tablets EU/1/08/441/003-004
Effentora 100 mikrogram bukkaltabletter EU/1/08/441/001-002 
Effentora 100 micrograms buccal tablets EU/1/08/441/001-002
Effentora 800 mikrogram bukkaltabletter EU/1/08/441/009-010 
Effentora 800 micrograms buccal tablets EU/1/08/441/009-010
Effentora 600 mikrogram bukkaltabletter EU/1/08/441/007-008 
Effentora 600 micrograms buccal tablets EU/1/08/441/007-008
Effentora 800 mikrogram bukkaltabletter Fentanyl 
Effentora 800 micrograms buccal tablets Fentanyl
Effentora 800 mikrogram bukkaltabletter 
Effentora 800 micrograms buccal tablets
Effentora 200 mikrogram bukkaltabletter 
Effentora 200 micrograms buccal tablets
Effentora 600 mikrogram bukkaltabletter 
Effentora 600 micrograms buccal tablets
Generel pruritus Alopeci 
Cold sweat Facial swelling Generalised pruritus Alopecia
Effentora 100 mikrogram bukkaltabletter Fentanyl 
Effentora 100 micrograms buccal tablets Fentanyl
Effentora 200 mikrogram bukkaltabletter Fentanyl 
Effentora 200 micrograms buccal tablets Fentanyl
Effentora 400 mikrogram bukkaltabletter Fentanyl 
Effentora 400 micrograms buccal tablets Fentanyl
Det skal De vide, før De begynder at tage Effentora Sådan skal De tage Effentora Bivirkninger 
What Effentora is and what it is used for What you need to knowbefore you use Effentora How to use Effentora
Effentora 600 mikrogram bukkaltabletter Fentanyl 
Effentora 600 micrograms buccal tablets Fentanyl
Dosistitrering 
Convulsion
maveubehag, fordøjelsesbesvær, tandpine, trøske 
stomach pain, uncomfortable stomach, indigestion, toothache, oral thrush
• 200 mikrogram fentanyl (som citrat) 
• 200 micrograms fentanyl (as citrate)
• 800 mikrogram fentanyl (som citrat) 
• 800 micrograms fentanyl (as citrate)
• 400 mikrogram fentanyl (som citrat) 
• 400 micrograms fentanyl (as citrate)
• kløe, voldsom svedtendens, udslæt 
• itching, excessive sweating, rash
Effentora 400 mikrogram bukkaltabletter 
Effentora 400 micrograms buccal tablets
Træk folien på bagsiden af blister-enheden af for at blotlægge tabletten. 
The backing foil should be peeled back to expose the tablet.
Så længe De ikke oplever gennembrudssmerter, skal De ikke tage Effentora. 
If the breakthrough pain has stopped, do not take Effentora until the next breakthrough pain episode.
Se pkt. 
Buccal tablet.
• 600 mikrogram fentanyl (som citrat) 
• 600 micrograms fentanyl (as citrate)
Effentora 100 mikrogram bukkaltabletter 
Effentora 100 micrograms buccal tablets
Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “8” 
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “8”.
• 100 mikrogram fentanyl (som citrat) 
• 100 micrograms fentanyl (as citrate)
Efterjustering af dosis 
Dose readjustment
Neonatalt abstinenssyndrom (se pkt. 
Pyrexia Neonatal withdrawal syndrome (see section 4.6)
Hver bukkaltablet indeholder 800 mikrogram fentanyl (som citrat) 
Each buccal tablet contains 800 micrograms fentanyl (as citrate)
Aktivt stof: fentanyl. 
The active substance is fentanyl.
Hver bukkaltablet indeholder 200 mikrogram fentanyl (som citrat). 
Each buccal tablet contains 200 micrograms fentanyl (as citrate)
Kvalme, opkastning, anoreksi, træthed, svaghed, svimmelhed og lavt blodtryk. 
Nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency.
Hver bukkaltablet indeholder 600 mikrogram fentanyl (som citrat). 
Each buccal tablet contains 600 micrograms fentanyl (as citrate)
Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “6” 
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “6”.
Hver bukkaltablet indeholder 100 mikrogram fentanyl (som citrat). 
Each buccal tablet contains 100 micrograms fentanyl (as citrate)
Hver bukkaltablet indeholder 400 mikrogram fentanyl (som citrat). 
Each buccal tablet contains 400 micrograms fentanyl (as citrate)
Forstoppelse Stomatitis Mundtørhed Diare 
Oral mucosal blistering Dry lip
• muskelsmerter, rygsmerter 
Muscle twitching Muscular weakness
Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “2” 
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “2”.
Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “1” 
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “1”.
• koldsved, hævet ansigt, generel kløe, hårtab, muskeltrækninger, muskelsvaghed, en følelse af ikke at have det godt, ubehag i brystet, tørst, man fryser eller har det varmt, besvær med at lade vandet 
feeling unwell, chest discomfort, thirst, feeling cold, feeling hot, difficulty passing urine
Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “4” 
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “4”.
Nyrer og urinveje 
redness, swelling or spots
Det er meget vigtigt, at De tager Effentora nøjagtigt efter lægens anvisning. 
It is very important that you use Effentora exactly as the doctor tells you The initial dose is 100 micrograms.
Opbevares utilgængeligt for børn. 
This medicine must be kept out of the sight and reach of children.
• stofafhængighed 
• drug dependence (addiction)
Pakningsstør relse 
Route of Administration
London, den 24. maj 2007 Ref.dok. 
London, 24 May 2007 Doc.
Hvad er Vitragan? 
What is Vitragan?
Virkningerne af Vitragan blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of Vitragan were first tested in experimental models before being studied in humans.
SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for VITRAGAN 
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for VITRAGAN
I udvalget var der desuden betænkelighed vedrørende lægemidlets sikkerhed og ensartetheden af de forskellige batches af lægemidlet. 
The Committee was also concerned over the safety of the medicine and the consistency of the medicine between batches.
Internationalt fællesnavn (INN): hyaluronidase (ovin) 
International non-proprietary name (INN): hyaluronidase (ovine)
Firmaet forelagde desuden resultaterne af to hovedundersøgelser med 1 306 patienter med glaslegemeblødning, hvor virkningen af en enkelt indsprøjtning af Vitragan blev sammenlignet med virkningen af placebo (virkningsløs behandling). 
The company also presented the results of two main studies involving 1,306 patients with vitreous haemorrhage, where the effects of a single injection of Vitragan were compared with those of placebo (a dummy treatment).
Hvor langt var man nået med vurderingen af ansøgningen, da den blev trukket tilbage? 
How far into the evaluation was the application when it was withdrawn?
Den 25. april 2007 meddelte ISTA Pharma Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at trække sin ansøgning om markedsføringstilladelse for Vitragan til behandling af glaslegemeblødning tilbage. 
On 25 April 2007, ISTA Pharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vitragan, for the treatment of vitreous haemorrhage.
Hvad forventedes Vitragan anvendt til? 
What was Vitragan expected to be used for?
EMEA/253854/2007 
Ref. EMEA/195786/2007
Det skulle benyttes til at fremstille en opløsning til indsprøjtning i øjet. 
It was to be made up into a solution for injection into the eye.
Hensigten var at forbedre synet og gøre det lettere for lægerne at diagnosticere den tilgrundliggende sygdom i nethinden (den lysfølsomme overflade bagest i øjet). 
This was intended to improve vision and to help doctors in their diagnosis of underlying problems in the retina (the light-sensitive surface at the back of the eye).
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Vitragan eller i programmer for anvendelse med særlig udleveringstilladelse? 
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Vitragan?
Hvordan forventes Vitragan at virke? 
How is Vitragan expected to work?
Det aktive stof i Vitragan, ovin hyaluronidase, er et enzym, der udvindes af får. 
The active substance in Vitragan, hyaluronidase (ovine), is an enzyme extracted from sheep.
Efter gennemgang af den indledende dokumentation opstiller CHMP på dag 120 en række spørgsmål, der sendes til firmaet. 
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Vitragan er er et pulver, der indeholder det aktive stof hyaluronidase (fra får). 
Vitragan is a powder containing the active substance hyaluronidase (ovine).
Virkningen blev hovedsagelig bedømt på bedringen i synet tre måneder efter injektionen, målt med en almindelig synstavle. 
The main measure of effectiveness was the improvement in vision three months after the injection, assessed using a standard letter chart.
Firmaet har til CHMP oplyst, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Vitragan. 
The company informed the CHMP that there are currently no clinical trials or compassionate use programmes with Vitragan.
På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Vitragan ikke var tilfredsstillende godtgjort, og at eventuelle fordele ikke opvejede de fundne risici. 
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Vitragan had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af spørgsmålene fra CHMP var der i CHMP betænkelighed på tilbagetrækningstidspunktet, og udvalgets foreløbige standpunkt var, at Vitragan ikke kunne godkendes til behandling af glaslegemeblødning. 
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vitragan could not have been approved for the treatment of vitreous haemorrhage.
På denne måde forventedes det, at fagocytterne (immunsystemets specialiserede "ædeceller") ville kunne fjerne blodklumper i glaslegemet. 
This was expected to allow phagocytes (specialised ‘scavenger' cells of the immune system) to clear away any blood clots from the vitreous humour.
Vitragan forventedes anvendt til behandling af blødning i glaslegemet (den geléagtige væske i øjets centrale del) hos voksne. 
Vitragan was expected to be used to treat vitreous haemorrhage (bleeding into the vitreous humour, the jelly-like fluid in the central chamber of the eye) in adults.
I CHMP var der betænkelighed over, at hovedundersøgelserne ikke på overbevisende måde havde vist, at Vitragan var mere effektivt end andre alternativer til behandling af glaslegemeblødning. 
The CHMP had concerns over the benefits of Vitragan, since the main studies had not shown convincingly that it was more effective than available options for managing vitreous haemorrhage.
Når hyaluronsyren nedbrydes, omdannes glaslegemets konsistens fra gelé til væske. 
When the acid is broken down, the vitreous humour turns from a jelly into a liquid, allowing cells to move more freely through the vitreous humour.
Det forventes at virke ved at nedbryde hyaluronsyre, som er et stof, der fines i glaslegemet. 
It is expected to work by breaking down a molecule in the vitreous humour called hyaluronic acid.
MF EU-nummer 
MA (EU) number (Invented) name Strength Pharmaceutical
Dag 5, dag 14 og dag 28 
Day 5, Day 14 and Day 28
Dato for seneste fornyelse: 18. februar 2016 
Date of latest renewal: 18 February 2016
Der er ikke fundet noget mønster i årsagerne til dødsfaldene. 
No pattern was identified in the causes of death.
Studie 2: extended criteria donorer 
Study 2: extended criteria donors
Langtidsopfølgning af Studie 1 og Studie 2 
Long-term extension in Study 1 and Study 2
Transplantationsdag, før implantation (Dag 1) 
Day of transplantation, prior to implantation (Day 1)
Det er vigtigt, at du læser hele PIL'en for yderligere oplysninger. 
It is important that you read the entire PL for more information.
Patienter med høj PRA har ofte brug for øget immunsuppression. 
Patients with high PRA often require increased immunosuppression.
Fra 4. uge efter transplantationen vil du få behandling med NULOJIX hver 4. uge. 
From week 4 after transplant, you will receive treatment with NULOJIX every 4 weeks.
PML medfører ofte svær invaliditet og død. 
PML often leads to severe disability or death.
NULOJIX er ikke undersøgt hos børn og unge under 18 år, og derfor anbefales det ikke til denne aldersgruppe. 
NULOJIX has not been studied in children and adolescents under 18 years of age, therefore it is not recommended in this age group.
Du får måske symptomer, som du ikke selv er klar over. 
You might get symptoms that you might not be aware of yourself.
Generelt forekom disse hændelser tidligt og størstedelen medførte transplantattab. 
In general, these events occurred early and the majority resulted in graft loss.
Belatacept bør ikke anvendes til gravide kvinder, medmindre dette anses for klart nødvendigt. 
Belatacept should not be used in pregnant women unless clearly necessary.
Fortæl din familie eller plejere om din behandling. 
Tell your family or caregiver about your treatment.
Dublin 15 - Irland 
Dublin 15 - Ireland
Ca. 80% af AR opstod ved måned 3 og var sjældne efter måned 6. 
Approximately 80% of AR episodes occurred by Month 3 and were infrequent after Month 6.
Almindelig depression 
Common depression
* Se afsnittet ”Beskrivelse af udvalgte bivirkninger”. 
* See section “Description of selected adverse reactions”.