natgillin/translations-raw huggingface dataset:
Du må ikke tage VIAGRA, hvis du tager medicin, som kaldes nitrogenoxiddonorer som f.eks. amylnitrit (“poppers”), da kombinationen også kan medføre potentielt farligt blodtryksfald.
You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.
• En allergisk reaktion - dette ses ikke almindeligt (kan ses hos op til 1 ud af 100 personer) Symptomerne omfatter pludselig hvæsende vejrtrækning, vejrtrækningsbesvær eller svimmelhed, hævelser af øjenlåg, ansigt, læber eller hals.
• An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
Pludselig hjertedød*, myokardieinfarkt, ventrikulær arytmi*, atrieflimren, ustabil angina
Myocardial infarction, Ventricular arrhythmia*, Atrial fibrillation, Unstable angina
VIAGRA 100 mg filmovertrukne tabletter EU/1/98/077/010-012
VIAGRA 100 mg film-coated tablets EU/1/98/077/010-012
Sådan skal du tage VIAGRA
How to take VIAGRA
Da sildenafil-clearance er nedsat hos patienter med alvorligt nedsat nyrefunktion (kreatininclearance <30 ml/min.)
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance
PFIZER ΕΛΛΑΣ A.E. (CYPRUS BRANCH) Τηλ: +357 22 81 7690
(CYPRUS BRANCH), Τηλ: +357 22 817690
VIAGRA 50 mg filmovertrukne tabletter EU/1/98/077/006-008
VIAGRA 50 mg film-coated tablets EU/1/98/077/006-008
Forstyrrelser i tåredannelsen*** ,øjensmerter, fotofobi, fotopsi, okulær hyperæmi, lysglimt, konjunktivitis
Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis
VIAGRA 25 mg filmovertrukne tabletter EU/1/98/077/002-004
VIAGRA 25 mg film-coated tablets EU/1/98/077/002-004
Hver tablet indeholder sildenafilcitrat svarende til 25, 50 eller 100 mg sildenafil.
Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil.
Cellulose, mikrokrystallinsk calciumhydrogenphosphat (vandfrit) croscarmellosenatrium magnesiumstearat
Tablet core: microcrystalline cellulose calcium hydrogen phosphate (anhydrous) croscarmellose sodium magnesium stearate
Tabletterne findes i blisterpakninger med 2, 4, 8, 12 eller 24 tabletter i en karton eller i en kortpakning.
The tablets are provided in blister packs containing 2, 4, 8, 12 or 24 tablets in a carton or card packaging.
Citronsmag indeholder: Maltodextrin Alfa tokoferol (E307)
Alpha-tocopherol (E307)
Myalgi,ekstremitetss merter
Myalgia, Pain in extremity
Hos frivillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) reduceres sildenafilclearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på henholdsvis 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
In volunteers with severe renal impairment (creatinine clearance <30 mL/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
Cellulose, mikrokrystallinsk Silica, hydrofob kolloid Croscarmellosenatrium Magnesiumstearat Indigotin I (E132) Sukralose
Microcrystalline cellulose Silica, hydrophobic colloidal Croscarmellose sodium Magnesium stearate Indigo carmine aluminium lake (E132) Sucralose
Gastroøsofagal refluksyndrom,opkast ning,smerter i øvre abdomen,mundtørhed
Gastro oesophagael reflux disease, Vomiting, Abdominal pain upper, Dry
Må ikke opbevares ved temperaturer over 30 °C.
Do not store above 30oC.
Cerebrovaskulær hændelse, transitorisk iskæmisk attak, krampeanfald*, tilbagevendende krampeanfald*, synkope
Cerebrovascular accident, Transient ischaemic attack, Seizure*, Seizure recurrence,* Syncope
VIAGRA er kontraindiceret til patienter, som på grund af non-arteritis anterior iskæmisk opticusneuropati (NAION) har nedsættelse af synet på det ene øje.
VIAGRA is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Aluminium-blisterplader i kartoner med 2, 4, 8 eller 12 tabletter.
Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.
- Hvis du bruger præparater, som kaldes nitrogenoxiddonorer som amylnitrit (“poppers”), da samtidig brug også kan medføre potentielt farligt blodtryksfald.
If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.
Cerebrovaskulær hændelse, transitorisk iskæmisk attak, krampeanfald*,tilbagevendende krampeanfald*, synkope
Cerebrovascular accident, Transient ischaemic attack, Seizure,* Seizure recurrence,* Syncope
Hypromellose titandioxid (E171) lactosemonohydrat triacetin indigotin I (E132)
Film coat: hypromellose titanium dioxide (E171) lactose monohydrate triacetin indigo carmine aluminium lake (E132)
Efter markedsføringen er der i forbindelse med brugen af VIAGRA rapporteret alvorlige kardiovaskulære hændelser, inklusiv myokardieinfarkt, ustabil angina pectoris, pludselig hjertedød, ventrikulær arytmi, cerebrovaskulær blødning, transitorisk cerebral iskæmi, hypertension og hypotension.
Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of VIAGRA.
De er mærket “PFIZER” på den ene side og “VGR 100” på den anden side.
They are marked “PFIZER” on one side and “VGR 100” on the other side.
Samtidig indgift af HIV-proteasehæmmeren ritonavir, som er en meget potent CYP-hæmmer, ved steady state (500 mg 2 gange dagligt) og enkeltdosis af sildenafil (100 mg) gav en stigning i sildenafils Cmax på 300% (4 gange) og en stigning i sildenafils plasma AUC på 1.000% (11 gange).
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
- Hvis du tager medicin, som kaldes nitrater, da samtidig brug kan medføre potentielt farligt blodtryksfald.
If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure.
- Filmovertræk: Hypromellose, titandioxid (E171), lactose, triacetin, indigotin I (E132).
hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin,
De er mærket “PFIZER” på den ene side og “VGR 25” på den anden side.
They are marked “PFIZER” on one side and “VGR 25” on the other side.
Samtidig indgift af HIV-proteasehæmmeren saquinavir, en CYP3A4-hæmmer, ved steady state (1.200 mg 3 gange dagligt) og enkeltdosis sildenafil (100 mg) gav en stigning i sildenafils Cmax på 140% og en stigning i sildenafils plasma AUC på 210%.
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Epistaxis,tilstopning af bihuler
Epistaxis, Sinus congestion
I overensstemmelse med dets kendte virkninger på nitrogenoxid/cyklisk guanosinmonofosfat (cGMP)vejen (se pkt.
Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates,
Median tmax er således forsinket med omkring 3,4 timer og gennemsnitlig Cmax er reduceret med omkring 59% sammenlignet med orodispergible tabletter taget under faste (se pkt.
When orodispersible tablets is taken with a high fat meal, the rate of absorption of sildenafil is reduced, median Tmax is delayed by about 3.4 hours and mean Cmax and AUC are reduced respectively by about 59% and 12%, compared to administration of orodispersible tablets under fasting conditions (See Section 4.2).
VIAGRA 25 mg filmovertrukne tabletter PVC/aluminium-blisterplader i kartoner med 2, 4, 8 eller 12 tabletter.
VIAGRA 25 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.
De er mærket “PFIZER” på den ene side og ”VGR 50” på den anden side.
They are marked “PFIZER” on one side and “VGR 50” on the other side.
Patienter der har behov for en dosisøgning til 100 mg, bør tage to 50 mg orodispergible tabletter lige efter hinanden.
The maximum recommended dose is 100 mg. For patients requiring a dose increase to 100 mg, two 50 mg orodispersible tablets should be administered sequentially.
Tag altid VIAGRA nøjagtigt efter lægens eller apotekspersonalets anvisning.
Always take this medicine exactly as your doctor or pharmacist has told you.
skal en 25 mg dosis overvejes.
<30 mL/min) a 25 mg dose should be considered.
Kontakt lægen, før du tager VIAGRA, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter, såsom lactose.
If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking VIAGRA.
VIAGRA 100 mg filmovertrukne tabletter PVC/aluminium-blisterplader i kartoner med 2, 4, 8, 12 eller 24 tabletter.
VIAGRA 100 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets
Samtidig anvendelse af nitrogenoxiddonorer eller nitrater i en hvilken som helst form er derfor kontraindiceret (se pkt.
and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Almindelig ( 1/100 og <1/10)
Rare ( 1/10,000 and <1/1,000)
Non-arteritis anterior iskæmisk opticusneuropati (NAION)*,vaskulær okklusion i retina*,blødning i retina,arteriosklerotisk retinopati,retinal sygdom,glaukom,synsfeltdefekt, diplopi,nedsat synsskarphed,myopi,astenopi, ”flyvende fluer”, sygdom i iris, mydriasis,farvet ring omkring lyskilder, øjenødem,hævede øjne, øjenlidelse,konjunktival hyperæmi,øjenirritation,unormal følelse i øjet,øjenlågsødem,skleral misfarvning
Non-arteritic anterior ischaemic optic neuropathy (NAION) Retinal vascular occlusion*, Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect, Diplopia, Visual acuity reduced, Myopia, Asthenopia, Vitreous floaters, Iris disorder, Mydriasis, Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in eye, Eyelid oedema, Scleral discoloration
2 filmovertrukne tabletter 4 filmovertrukne tabletter 8 filmovertrukne tabletter 12 filmovertrukne tabletter
2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets
Det skal du vide, før du begynder at tage VIAGRA Sådan skal du tage VIAGRA Bivirkninger
What VIAGRA is and what it is used for What you need to know before you take VIAGRA How to take VIAGRA
VIAGRA filmovertrukne tabletter er blå med en afrundet rhombisk form.
What VIAGRA looks like and contents of the pack VIAGRA film-coated tablets are blue, with a rounded-diamond shape.
Ikke almindelig ( 1/1.000 og
Uncommon ( 1/1,000 and
EU/1/98/077/020 (2 orodispergible tabletter) EU/1/98/077/021 (4 orodispergible tabletter) EU/1/98/077/022 (8 orodispergible tabletter) EU/1/98/077/023 (12 orodispergible tabletter)
EU/1/98/077/020 (2 orodispersible tablets) EU/1/98/077/021 (4 orodispersible tablets) EU/1/98/077/022 (8 orodispersible tablets) EU/1/98/077/023 (12 orodispersible tablets)
VIAGRA 50 mg orodispergible tabletter
VIAGRA 50 mg orodispersible tablets
Du bør være på en regelmæssig daglig dosis af alfa-blokkeren, før du tager VIAGRA, for at nedsætte risikoen for at disse symptomer opstår.
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start VIAGRA.
Du må ikke tage VIAGRA, hvisdu tager medicin, som kaldesnitrater, da kombinationen af disse kan medføre potentielt farligt blodtryksfald.
You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure.
Farmakoterapeutisk gruppe: Urogenitalsystem og kønshormoner: Systemiske midler til erektil dysfunktion.
Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC Code: G04B E03.
Blå, afrundede rhombeformede tabletter, mærket ”V50”på den ene side og uden prægning på den anden side.
Blue, rounded, diamond-shaped tablets, marked “V50” on one side and plain on the other.
Almindelig (kan ses hos op til 1 ud af 10 personer): kvalme, ansigtsrødme, hedeture (symptomerne omfatter en pludselig følelse af hede i overkroppen), dårlig fordøjelse, farvesyn, sløret syn, synsforstyrrelser, tilstoppet næse og svimmelhed.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Hvis du har taget for mange VIAGRA
If you take more VIAGRA than you should:
VIAGRA orodispergible tabletter er blå med rhombisk form, mærket “V50” på den ene side.
What VIAGRA looks like and contents of the pack VIAGRA orodispersible tablets are blue, diamond shape, marked “V50” on one side.
Sjælden (kan ses hos op til 1 ud af 1.000 personer): besvimelse, slagtilfælde, hjerteanfald, uregelmæssig hjerterytme, midlertidigt nedsat blodtilførsel til dele af hjernen, følelse af, at halsen snører sig sammen, følelsesløshed i munden, blødninger i den bagerste del af øjet, dobbeltsyn, nedsat synsskarphed, unormal følelse i øjet, hævede øjne eller øjenlåg, små partikler eller pletter i synsfeltet, se en farvet ring omkring lyskilder, forstørrede pupiller, misfarvning af det hvide i øjet, blødning fra penis, blod i sæden, næsetørhed, hævelse inde i næsen, følelse af irritation og pludselig hørenedsættelse eller høretab.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen,dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
Blødning fra penis, priapisme*,hæmatospermi, forlænget erektion
Penile haemorrhage, Priapism*,
VIAGRA bør ikke anvendes af kvinder.
You should not take VIAGRA if you are a woman.
Blå, afrundede rhombeformede tabletter, mærket “PFIZER” på den ene side og "VGR 100” på den anden side.
VIAGRA 100 mg tablets Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 100” on the other.
Tabletterne findes i blisterpakninger med 2, 4, 8, 12 eller 24 tabletter.
The tablets are provided in blister packs containing 2, 4, 8, 12 or 24 tablets.
De orodispergible tablettern findes i blisterpakninger med 2, 4, 8 eller 12 tabletter.
The orodispersible tablets are provided in blister packs containing 2, 4, 8 or 12 tablets.
VIAGRA 50 mg orodispergible tabletter Sildenafil
VIAGRA 50 mg orodispersible tablets Sildenafil
Blå, afrundede rhombeformede tabletter, mærket “PFIZER” på den ene side og "VGR 25” på den anden side.
VIAGRA 25 mg tablets Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 25” on the other.
Hver orodispergibel tablet indeholder 50 mg sildenafil (som citratsalt).
Each orodispersible tablet contains 50 mg of sildenafil (as the citrate salt).
VIAGRA 25 mg tabletter Sildenafil
VIAGRA 25 mg tablets Sildenafil
VIAGRA 100 mg filmovertrukne tabletter
VIAGRA 100 mg film-coated tablets
VIAGRA 25 mg filmovertrukne tabletter
VIAGRA 25 mg film-coated tablets
VIAGRA 100 mg tabletter Sildenafil
VIAGRA 100 mg tablets Sildenafil
Hver tablet indeholder sildenafilcitrat svarende til 25 mg sildenafil
Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil
VIAGRA 50 mg filmovertrukne tabletter
VIAGRA 50 mg film-coated tablets
Blå, afrundede rhombeformede tabletter, mærket “PFIZER” på den ene side og "VGR 50” på den anden side.
VIAGRA 50 mg tablets Blue, rounded, diamond-shaped tablets, marked “PFIZER” on one side and “VGR 50” on the other.
Hver tablet indeholder sildenafilcitrat svarende til 100 mg sildenafil
Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil
Er du i tvivl så spørg lægen eller på apoteket.
If you have any further questions, ask your doctor, pharmacist or nurse.
EU/1/98/077/015 (2 filmovertrukne tabletter) EU/1/98/077/010 (4 filmovertrukne tabletter) EU/1/98/077/011 (8 filmovertrukne tabletter) EU/1/98/077/012 (12 filmovertrukne tabletter) EU/1/98/077/025 (24 filmovertrukne tabletter)
EU/1/98/077/015 (2 film-coated tablets) EU/1/98/077/010 (4 film-coated tablets) EU/1/98/077/011 (8 film-coated tablets) EU/1/98/077/012 (12 film-coated tablets) EU/1/98/077/025 (24 film-coated tablets)
EU/1/98/077/016 (2 filmovertrukne tabletter EU/1/98/077/017 (4 filmovertrukne tabletter) EU/1/98/077/018 (8 filmovertrukne tabletter) EU/1/98/077/019 (12 filmovertrukne tabletter)
EU/1/98/077/016 (2 film-coated tablets) EU/1/98/077/017 (4 film-coated tablets) EU/1/98/077/018 (8 film-coated tablets) EU/1/98/077/019 (12 film-coated tablets)
VIAGRA 50 mg tabletter Sildenafil
VIAGRA 50 mg tablets Sildenafil
Tabletterne findes i blisterpakninger med 2, 4, 8 eller 12 tabletter.
The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets.
VIAGRA er til behandling af voksne mænd med erektil dysfunktion, ogsål kendt som impotens, hvilket er manglende evne til at opnå og/eller opretholde erektion tilstrækkelig til at gennemføre tilfredsstillende seksuel aktivitet.
VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Hæmaturi
Povidone
Hver tablet indeholder sildenafilcitrat svarende til 50 mg sildenafil.
Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
VIAGRA 25 mg filmovertrukne tabletter Sildenafil
VIAGRA 25 mg film-coated tablets Sildenafil
Hjerte
mouth
VIAGRA 100 mg filmovertrukne tabletter Sildenafil
VIAGRA 100 mg film-coated tablets Sildenafil
EU/1/98/077/013 (2 filmovertrukne tabletter) EU/1/98/077/002 (4 filmovertrukne tabletter) EU/1/98/077/003 (8 filmovertrukne tabletter) EU/1/98/077/004 (12 filmovertrukne tabletter)
EU/1/98/077/013 (2 film-coated tablets) EU/1/98/077/002 (4 film-coated tablets) EU/1/98/077/003 (8 film-coated tablets) EU/1/98/077/004 (12 film-coated tablets)
EU/1/98/077/014 (2 filmovertrukne tabletter) EU/1/98/077/006 (4 filmovertrukne tabletter) EU/1/98/077/007 (8 filmovertrukne tabletter) EU/1/98/077/008 (12 filmovertrukne tabletter) EU/1/98/077/024 (24 filmovertrukne tabletter)
EU/1/98/077/014 (2 film-coated tablets) EU/1/98/077/006 (4 film-coated tablets) EU/1/98/077/007 (8 film-coated tablets) EU/1/98/077/008 (12 film-coated tablets) EU/1/98/077/024 (24 film-coated tablets)
4.4 ), bør en startdosis på 25 mg overvejes til patienter i samtidig behandling med andre CYP3A4-hæmmere (se pkt.
Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
4.4), bør en startdosis på 25 mg overvejes til patienter i samtidig behandling med andre CYP3A4-hæmmere (se pkt.
Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4), a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Hver tablet indeholder sildenafilcitrat svarende til 50 mg sildenafil
Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil
VIAGRA 50 mg filmovertrukne tabletter Sildenafil
VIAGRA 50 mg film-coated tablets Sildenafil
C.
oC.
EU-nummer Særnavn Styrke Lægemiddelform
EU Number Invented Name Strength Pharmaceutical Form
Indgivelsesvej Emballage IndholdPakningsstørrelseTilbageholdelsestid
Content Package size Withdrawal period
Dette blev vurderet ved at måle antallet af bogstaver, som de kunne se på en standard synstavle: Et fald på 15 bogstaver eller mere over seks måneder ansås for at være et synstab.
This was assessed by measuring the number of letters they could see on a standard vision chart: a fall of 15 letters or more over six months was considered to be a loss of vision.
London, den 22. marts 2007 Ref.-dok.
London, 22 March 2007 Doc.
Hvad er ARXXANT?
What is ARXXANT?
Internationalt fællesnavn (INN): ruboxistaurin
International non-proprietary name (INN): ruboxistaurin
SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNING OM MARKEDSFØRINGSTILLADELSE for ARXXANT
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for ARXXANT
EMEA/44517/2008
Ref. EMEA/117441/2007
Retinopati kan i sidste ende medføre tab af syn og endda blindhed.
Retinopathy can eventually lead to a loss of vision and even blindness.
'Non-proliferativ' betyder, at sygdommen er på et tidligt stadium, hvor patienten måske endnu ikke har bemærket nogen forandringer i synet.
‘Non-proliferative' means that the disease is an early stage, during which the patient may not notice any change in vision.
Udvalget var også betænkelig ved lægemidlets bivirkninger, især med hensyn til forstyrrelser af hjerterytmen.
The committee also had concerns over the medicine's side effects, particularly disturbances of the heart rhythm.
Det primære mål for virkning var andelen af patienter i hver gruppe med et synstab ved afslutningen af undersøgelsen.
The main measure of effectiveness was the proportion of patients in each group who experienced a loss of vision at the end of the study.
Virkningerne af ARXXANT blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of ARXXANT were first tested in experimental models before being studied in humans.
Hvilken dokumentation fremlagde virksomheden som støtte for sin ansøgning til CHMP?
What documentation did the company present to support its application to the CHMP?
ARXXANT er et lægemiddel, der indeholder det aktive stof ruboxistaurin (som 32 mg tabletter).
ARXXANT is a medicine that contains the active substance ruboxistaurin (as 32 mg tablets).
Hvad forventes ARXXANT anvendt til?
What was ARXXANT expected to be used for?
I undersøgelsen sammenlignedes virkningen af ARXXANT med placebo (uvirksomhed behandling) over tre år.
The study compared the effects of ARXXANT and placebo (a dummy treatment) over three years.
Ansøgningen var nået til dag 120 i ansøgningsprocessen, da virksomheden trak den tilbage.
The application was at day 120 when the company withdrew.
Hvilke konsekvenser får tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med ARXXANT?
What are the consequences of the withdrawal for patients undergoing clinical trials with ARXXANT?
Hvordan forventes ARXXANT at virke?
How is ARXXANT expected to work?
Når virksomheden har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål (omkring dag 180) til
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Hvad anbefalede CHMP på det tidspunkt?
What was the recommendation of the CHMP at that time?
Virksomheden fremlagde resultaterne af en hovedundersøgelse med 685 patienter med moderat svær til meget svær non-proliferativ diabetisk retinopati.
The company presented the results of one main study involving 685 patients with moderately severe to very severe non-proliferative diabetic retinopathy.