FrancophonIA/ELRC3.0 huggingface dataset:
English: With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was -3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was observed (baseline 30.0 points).
Danish: Med rotigotin var den gennemsnitlige forbedring i UPDRS scoren (del II og III)-3,98 point (baseline 29,9 point), mens der i den behandlingsarm, der fik placebo, sås en forværring på 1,31 point (baseline 30,0 point).
English: At the beginning of the fourth week, you should take Neupro 8 mg (package marked with “Week 4”).
Danish: I den fjerde uge anvendes Neupro 8 mg (æske mærket ”Uge 4”).
English: How to use the Neupro patches:
Danish: Sådan skal Neupro-plasteret bruges:
English: Atrial fibrillation Supraventricular tachycardia
Danish: Atriefibrillation Supraventrikul ær takykardi
English: Palpitationse, atrial fibrillatione, supraventricular tachycardiae
Danish: Palpitationere, atriefibrillatione supraventrikul ær takykardie
English: At the beginning of the third week, you should take Neupro 6 mg (package marked with “Week 3”).
Danish: I den tredje uge anvendes Neupro 6 mg (æske mærket ”Uge 3”).
English: For example the daily dose of 10 mg may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.
Danish: For eksempel kan den daglig dosis på 10 mg nås ved at bruge ét plaster på 6 mg/24 timer og ét plaster på 4 mg/24
English: What Neupro contains
Danish: Neupro indeholder:
English: hallucination, hallucination visual, hallucination auditory, illusion), nightmaree, paranoia e, confusional state e, psychotic disorder e, delusion e, delirium e
Danish: hallucinationer, visuelle hallucinationer, auditive hallucinationer, illusioner), mareridte, paranoiae, forvirringe, psykotisk lidelsee, vrangforestilling ere, deliriume
English: Application and instillation site reactionsa (incl.
Danish: Reaktioner på administratio nssteda (inkl.
English: Oedema peripheral, asthenic conditionsa (incl.
Danish: Perifert ødem, asteniske tilstandea (inkl.
English: Erythemae, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede
Danish: Erytheme, hyperhidrosise, generaliseret prurituse, hudirritatione, kontaktdermatiti se, generaliseret udslæte
English: • For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available strengths),
Danish: • Til doser højere end 8 mg/24 timer (doser ordineret af Deres læge som er højere end de tilgængelige styrker ) bruges flere plastre for at opnå den endelige dosis.
English: Each patch of 30 cm2 contains 13.5 mg of rotigotine.
Danish: Hvert plaster på 30 cm2 indeholder 13,5 mg rotigotin.
English: Each patch of 15 cm2 contains 6.75 mg of rotigotine.
Danish: Hvert plaster på 15 cm2 indeholder 6,75 mg rotigotin.
English: This is because the effects of rotigotine on pregnancy and the unborn baby are not known.
Danish: Graviditet og amning Brug ikke Neupro, hvis De er gravid, da rotigotins effekt på graviditet og det ufødte barn ikke kendes.
English: • Restless Legs Syndrome (RLS) - this can be associated with discomfort in your legs or arms,
Danish: • Restless legs-syndrom (uro i benene (RLS)) - en tilstand som karakteriseres ved ubehag i arme eller ben, trang til at bevæge sig rundt, søvnforstyrrelser og følelse af at være træt eller døsig i løbet af dagen.
English: What Neupro contains The active substance is rotigotine.
Danish: Neupro indeholder det aktive stof rotigotin.
English: AST, ALT, GGT), weight increased e, heart rate increased e, CPK increased d,e
Danish: ASAT, ALAT, GGT), vægtøgninge, øget pulse, forhøjet CKd,e
English: At the beginning of the second week, you should take Neupro 4 mg (package marked with “Week 2”).
Danish: I den anden uge anvendes Neupro 4 mg (æske mærket ”Uge 2”).
English: Each patch of 40 cm2 contains 18.0 mg of rotigotine.
Danish: Hvert plaster på 40 cm2 indeholder 18,0 mg rotigotin.
English: Immune system disorders
Danish: Immunsysteme
English: Constipatione, dry mouthe, abdominal paine, diarrhoeac
Danish: Forstoppelsee, mundtørhede, abdominalsmer tere, diarréc
English: syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy
Danish: synkope, vasogal synkope, tab af bevidsthed), dyskinesie, postural
English: hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disorders a,d
Danish: hyperseksualitet , øget libido), søvnløshed, søvnforstyrrelse r, unormale drømme, impulskontrolfo rstyrrelsera,d
English: Nervous system disorders
Danish: Nervesystemet Hovedpine Døsighed
English: Palpitationse, atrial fibrillatione, supraventricular tachycardia e
Danish: Palpitationere, atriefibrillatione, supraventrikulæ r takykardie
English: Disturbances in consciousness NECa (incl.
Danish: Bevidsthedsfor styrrelser NEC a (inkl.
English: Each patch of 20 cm2 contains 9.0 mg of rotigotine.
Danish: Hvert plaster på 20 cm2 indeholder 9,0 mg rotigotin.
English: Fall a High Level Term b Observed in open-label studies c Observed during post-marketing d
Danish: Fald a) Overordnet begreb (high level term) b) Observeret i åbne studier c) Observeret efter markedsføring d) Observeret i data pool af dobbeltblinde, placebokontrollerede studier i 2011
English: Each patch of 5 cm2 contains 2.25 mg of rotigotine.
Danish: Hvert plaster på 5 cm2 indeholder 2,25 mg rotigotin.
English: The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h'.
Danish: Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h eller 8 mg/24 h”.
English: Neupro 1 mg/24 h transdermal patch Each patch releases 1 mg of rotigotine per 24 hours.
Danish: Neupro 1 mg/24 timer depotplaster Hvert plaster afgiver 1 mg rotigotin pr. 24 timer.
English: AST, ALT, GGT), weight increased, heart rate increased, CPK increasedd
Danish: ASAT, ALAT, GGT), vægtøgning, øget puls, forhøjet CKd
English: The outside is tan-coloured and is imprinted with Neupro 1 mg/24 h or 3 mg/24 h.
Danish: Ydersiden er beige og påtrykt Neupro 1 mg/24 h eller Neupro 3 mg/24 h.
English: • 8 mg/24 h:
Danish: • 8 mg/24 timer:
English: Warnings and precautions Talk to your doctor or pharmacist before using Neupro.
Danish: Kontakt lægen eller apotekspersonalet, før De bruger Neupro.
English: Neupro 8 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 8 mg/24 h'.
Danish: Neupro 8 mg/24 timer depotplaster Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 8 mg/24 h”.
English: The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h'.
Danish: Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 2 mg/24 h”.
English: Each patch of 10 cm2 contains 4.5 mg of rotigotine.
Danish: Hvert plaster på 10 cm2 indeholder 4,5 mg rotigotin.
English: What Neupro is and what it is used for What you need to know before you use Neupro How to use Neupro
Danish: Det skal De vide, før De begynder at bruge Neupro Sådan skal De bruge Neupro Bivirkninger
English: Neupro 1 mg/24 h transdermal patch Neupro 3 mg/24 h transdermal patch
Danish: Neupro 1 mg/24 timer depotplaster Neupro 3 mg/24 timer depotplaster
English: Dopamine dysregulation syndromec, perception disturbancese
Danish: Dopamindysregulationssyndromc, sanseforstyrrels ere (inkl.
English: The outside is tan-coloured and is imprinted with Neupro 4 mg/24 h, Neupro 6 mg/24 h or Neupro 8 mg/ 24 h.
Danish: Ydersiden er beige og påtrykt Neupro 4 mg/24 h eller Neupro 6 mg/24 h eller Neupro 8 mg/24 h
English: • 6 mg/24 h:
Danish: • 6 mg/24 timer:
English: Neupro 6 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 6 mg/24 h'.
Danish: Neupro 6 mg/24 timer depotplaster Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 6 mg/24 h”.
English: neupro 8 mg/24 h
Danish: Neupro 8 mg/24 timer
English: 7 transdermal patches of Neupro 6 mg/24 h
Danish: 7 depotplastre med Neupro 6 mg/24 timer
English: Neupro 4 mg/24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Danish: Neupro 4 mg/24 timer depotplaster Hvert plaster afgiver 4 mg rotigotin pr. 24 timer.
English: Neupro 1 mg/24 h transdermal patch EU/1/05/331/038
Danish: Neupro 1 mg/24 timer depotplaster EU/1/05/331/038
English: 7 transdermal patches of Neupro 8 mg/24 h
Danish: 7 depotplastre med Neupro 8 mg/24 timer
English: neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
Danish: Neupro 2 mg/24 timer 4 mg/24 timer 6 mg/24 timer 8 mg/24 timer
English: Neupro 6 mg/24 h
Danish: Neupro 6 mg/24 timer
English: Diarrhoeac
Danish: Diarréc
English: syncope, syncope vasovagal, loss of consciousness), dyskinesiae, dizziness posturale, lethargye, convulsion e
Danish: synkope, vasovagal synkope, tab af bevidsthed), dyskinesi, postural svimmelhed, letargi
English: The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
Danish: Ydersiden er beige og påtrykt Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h eller 8 mg/24 h.
English: The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h.
Danish: Ydersiden er beige og påtrykt Neupro 2 mg/24 h.
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity), asthenic conditions a
Danish: erythem, pruritus, irritation, udslæt, dermatitis, vesikler, smerte, eksem, inflammation, hævelse, misfarvning, papler, eksfoliation, urticaria, overfølsomhed) , asteniske symptomera(ink
English: Neupro 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 4 mg/24 h'.
Danish: Neupro 4 mg/24 timer depotplaster Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 4 mg/24 h”.
English: Neupro 6 mg/24 h transdermal patch EU/1/05/331/007
Danish: Neupro 6 mg/24 timer depotplaster EU/1/05/331/007
English: 7 transdermal patches of Neupro 4 mg/24 h
Danish: 7 depotplastre med Neupro 4 mg/24 timer
English: Disturbances in consciousness NEC
Danish: Svimmelhede, bevidsthedsforst yrrelser NECe
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apotekspersonalet.
English: Neupro 8 mg/24 h transdermal patch EU/1/05/331/010
Danish: Neupro 8 mg/24 timer depotplaster EU/1/05/331/010
English: Neupro 4 mg/24 h transdermal patch EU/1/05/331/004
Danish: Neupro 4 mg/24 timer depotplaster EU/1/05/331/004
English: Neupro 2 mg/24 h
Danish: Neupro 2 mg/24 timer
English: Neupro 2 mg/24 h Neupro 4 mg/24 h Neupro 6 mg/24 h Neupro 8 mg/24 h Transdermal patch
Danish: Neupro 2 mg/24 timer Neupro 4 mg/24 timer Neupro 6 mg/24 timer Neupro 8 mg/24 timer
English: Neupro 3 mg/24 h transdermal patch EU/1/05/331/047
Danish: Neupro 3 mg/24 timer depotplaster EU/1/05/331/047
English: How to use the Neupro patches
Danish: Hvis De har brugt for mange Neupro-plastre
English: Neupro 8 mg/24 h transdermal patch rotigotine
Danish: Neupro 8 mg/24 timer depotplaster rotigotin
English: EU/1/05/331/047 [7 transdermal patches] EU/1/05/331/049 [28 transdermal patches] EU/1/05/331/050 [30 transdermal patches] EU/1/05/331/058 [14 transdermal patches]
Danish: EU/1/05/331/047[7 depotplastre] EU/1/05/331/049 [28 depotplastre] EU/1/05/331/050 [30 depotplastre] EU/1/05/331/058 [14 depotplastre]
English: Perception disturbancesa
Danish: Sanseforstyrrel sera
English: a
Danish: Det
English: Neupro 4 mg/24 h
Danish: Neupro 4 mg/24 timer
English: EU/1/05/331/038 [7 transdermal patches] EU/1/05/331/040 [28 transdermal patches] EU/1/05/331/041 [30 transdermal patches] EU/1/05/331/056 [14 transdermal patches]
Danish: EU/1/05/331/038[7 depotplastre] EU/1/05/331/040 [28 depotplastre] EU/1/05/331/041 [30 depotplastre] EU/1/05/331/056 [14 depotplastre]
English: Dizzinesse, disturbances in consciousness NECe (incl.
Danish: Svimmelhede, bevidsthedsfors tyrrelser NECe
English: EU/1/05/331/010 [7 transdermal patches] EU/1/05/331/011 [28 transdermal patches] EU/1/05/331/033 [30 transdermal patches] EU/1/05/331/061 [14 transdermal patches]
Danish: EU/1/05/331/010 [7 depotplastre] EU/1/05/331/011 [28 depotplastre] EU/1/05/331/033 [30 depotplastre] EU/1/05/331/061 [14 depotplastre]
English: • 4 mg/24 h: Each patch releases 4 mg of rotigotine per 24 hours.
Danish: • 4 mg/24 timer Hvert plaster afgiver 4 mg rotigotin pr. 24 timer.
English: Neupro 2 mg/24 h 4 mg/24 h 6 mg/24 h 8 mg/24 h
Danish: Neupro 2 mg/24 timer 4 mg/24 timer 6 mg/24 timer 8 mg/24 timer Depotplaster
English: sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
Danish: Ascorbylpalmitat (E 304) og
English: Neupro 6 mg/24 h transdermal patch rotigotine
Danish: Neupro 6 mg/24 timer depotplaster rotigotin
English: EU/1/05/331/004 [7 transdermal patches] EU/1/05/331/005 [28 transdermal patches] EU/1/05/331/021 [30 transdermal patches] EU/1/05/331/059 [14 transdermal patches]
Danish: EU/1/05/331/004 [7 depotplastre] EU/1/05/331/005 [28 depotplastre] EU/1/05/331/021 [30 depotplastre] EU/1/05/331/059 [14 depotplastre]
English: EU/1/05/331/007 [7 transdermal patches] EU/1/05/331/008 [28 transdermal patches] EU/1/05/331/027 [30 transdermal patches] EU/1/05/331/060 [14 transdermal patches]
Danish: EU/1/05/331/007 [7 depotplastre] EU/1/05/331/008 [28 depotplastre] EU/1/05/331/027 [30 depotplastre] EU/1/05/331/060 [14 depotplastre]
English: Neupro 4 mg/24 h transdermal patch Neupro 6 mg/24 h transdermal patch Neupro 8 mg/24 h transdermal patch
Danish: Neupro 4 mg/24 timer depotplaster Neupro 6 mg/24 timer depotplaster Neupro 8 mg/24 timer depotplaster
English: EU/1/05/331/001 [7 transdermal patches] EU/1/05/331/002 [28 transdermal patches] EU/1/05/331/015 [30 transdermal patches] EU/1/05/331/057 [14 transdermal patches]
Danish: EU/1/05/331/001 [7 depotplastre] EU/1/05/331/002 [28 depotplastre] EU/1/05/331/015 [30 depotplastre] EU/1/05/331/057 [14 depotplastre]
English: h may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.
Danish: For eksempel kan en daglig dosis på 10 mg nås ved at bruge ét plaster på 6 mg/24 timer og ét plaster på 4 mg/24 timer.
English: Vision blurrede, visual impairmente, photopsiae
Danish: Sløret syn, nedsat syn, fotopsi
English: Neupro 2 mg/24 h transdermal patch rotigotine
Danish: Neupro 2 mg/24 timer depotplaster rotigotin
English: Neupro 4 mg/24 h transdermal patch Rotigotine
Danish: Neupro 4 mg/24 timer depotplaster rotigotin
English: EU/1/05/331/036 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/036 [84 depotplastre (3 pakninger a 28)]
English: pathological gambling, stereotypy/ punding, binge eating/eating disorderb, compulsive shoppingc)
Danish: ludomani, stereotypi/tvang shandlinger, uhæmmet madindtagelse/s piseforstyrrelseb
English: EU/1/05/331/018 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/018 [84 depotplastre (3 pakninger a 28)]
English: EU/1/05/331/053 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/053 [84 depotplastre (3 pakninger a 28)]
English: EU/1/05/331/024 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/024 [84 depotplastre (3 pakninger a 28)]
English: On the first day of treatment the patient starts with Neupro 2 mg/24 h. During the second week, the patient takes Neupro 4 mg/24 h. During the third week, he or she takes Neupro 6 mg/24 h and during the fourth week Neupro 8 mg/24 h. The packages are marked with “Week 1 (2, 3 or 4)”.
Danish: I den tredje uge anvender han eller hun Neupro 6 mg/24 timer og i den fjerde uge Neupro 8 mg/24 timer.
English: EU/1/05/331/030 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/030 [84 depotplastre (3 pakninger a 28)]
English: EU/1/05/331/044 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/044 [84 depotplastre(3 pakninger a 28)]
English: It is available as pink tablets (75 mg).
Danish: Det fås som lyserøde tabletter (75 mg).
English: Clopidogrel Teva can be given to the following groups of patients:
Danish: Clopidogrel Teva kan gives til følgende patientgrupper:
English: Other information about Clopidogrel Teva:
Danish: Andre oplysninger om Clopidogrel Teva:
English: The standard dose of Clopidogrel Teva is one 75 mg tablet once a day, taken with or without food.
Danish: Standarddosis af Clopidogrel Teva er én 75 mg -tablet én gang dagligt med eller uden et måltid.
English: Clopidogrel Teva clopidogrel EPAR summary for the public
Danish: Clopidogrel Teva clopidogrel EPAR - sammendrag for offentligheden
English: In acute coronary syndrome, Clopidogrel Teva is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Danish: Ved akut koronarsyndrom anvendes Clopidogrel Teva sammen med aspirin, og behandlingen indledes almindeligvis med en initialdosis på fire 75 mg -tabletter.
English: This means that Clopidogrel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Teva er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder Plavix.
English: The full EPAR for Clopidogrel Teva can be found here.
Danish: Den fuldstændige EPAR for Clopidogrel Teva findes her.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Teva to Teva Pharma B.V. on 28 July 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Teva til Teva Pharma B.V.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Danish: • patienter med perifer ateriesygdom (problemer med blodgennemstrømningen i arterierne)
English: It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or ‘non-Q-wave' myocardial infarction.
Danish: Det kan også anvendes til patienter, der ikke har denne unormale visning på EKG'et, hvis de har ustabil angina (en alvorlig form for brystsmerter) eller myokardieinfarkt uden forekomst af Q-takker.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Teva has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: Clopidogrel Teva is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel Teva anvendes til forebyggelse af aterotrombotiske hændelser hos voksne patienter (problemer forårsaget af blodpropper og åreforkalkning).
English: What are the benefit and risk of Clopidogrel Teva?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Teva?
English: Clopidogrel Teva is a ‘generic medicine'.
Danish: Clopidogrel Teva er et ‘generisk lægemiddel'.
English: The Committee recommended that Clopidogrel Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Teva.
English: Clopidogrel Teva can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Danish: Clopidogrel Teva kan anvendes til patienter, som har myokardieinfarkt med ”forhøjelse af ST-segmentet” (STelevation), dvs. en unormal visning på elektrokardiogrammet (EKG), når lægen vurderer, at patienterne kan have gavn af denne behandling.
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Danish: Clopidrogel forhindrer blodpladerne i at aggregere ved at forhindre et stof, ADP, i at binde sig til en særlig receptor på overfladen af disse.
English: Clopidogrel Teva can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel Teva kan påbegyndes få dage efter anfaldet og indtil 35 dage efter
English: Clopidogrel Teva is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Teva er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: Clopidogrel Teva can be started between seven days and six months after the stroke;
Danish: Behandling med Clopidogrel Teva kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter
English: Because Clopidogrel Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Clopidogrel Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Clopidogrel Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: The active substance in Clopidogrel Teva, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Teva, clopidogrel, er en blodpladeaggregationshæmmer.
English: Why has Clopidogrel Teva been approved?
Danish: Hvorfor blev Clopidogrel Teva godkendt?
English: How has Clopidogrel Teva been studied?
Danish: Hvordan blev Clopidogrel Teva undersøgt?
English: What is Clopidogrel Teva used for?
Danish: Hvad anvendes Clopidogrel Teva til?
English: How is Clopidogrel Teva used?
Danish: Hvordan anvendes Clopidogrel Teva?
English: How does Clopidogrel Teva work?
Danish: Hvordan virker Clopidogrel Teva?
English: Neutropenia lasted on average 1.6 days with both medicines.
Danish: Neutropenien varede i gennemsnit 1,6 dage ved begge lægemidler.
English: Further information on Pelgraz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Pelgraz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Pelgraz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Pelgraz i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: What measures are being taken to ensure the safe and effective use of Pelgraz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pelgraz?
English: Side effects reported with Pelgraz are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Pelgraz vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: As for all medicines, data on the use of Pelgraz are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Pelgraz løbende overvåget.
English: The most common side effect with Pelgraz (which may affect more than 1 in 10 people) is pain in the bones.
Danish: Den hyppigste bivirkning ved Pelgraz (der kan forekomme hos op til 1 ud af 10 patienter) er knoglesmerter.
English: Other information about Pelgraz
Danish: Andre oplysninger om Pelgraz
English: For more information about using Pelgraz, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Pelgraz, se indlægssedlen eller kontakt lægen eller apotekspersonalet.