FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreased appetite, anxiety or worsened anxiety, hallucinations, inability to fall or stay asleep, agitation, disorientation, depression or worsened depression, nervousness, mood swings, mental status changes (thinking abnormal, confusion), paranoia, irritability, worsened confusion, difficulty with learning, memory or thinking, reflexes absent or impaired, problems expressing or understanding words, slurred speech, difficulty with speech or loss of ability to speak, sluggishness, balance or coordination impaired, burning sensation, increased abnormal sensation, reduced level of consciousness (unresponsive or almost unconscious), sedation, difficulty in concentrating, problems with the sense of smell, odd or no sense of taste, shaking, pins and needles, double vision, visual disturbance, intolerance to light, tinnitus (ringing in the ears), dizziness or spinning sensation, lightheadedness or dizziness when standing, low blood pressure, shortness of breath, dry mouth, abdominal pain, worsened nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms, muscle cramp, muscle or joint pain, difficult or painful urination, difficulty starting or controlling urination, feeling jittery, falling, pain or pain exacerbated, fatigue, feeling cold, swelling of the face, legs or feet, chest pain, blood chemistry changes, mental impairment and weight decreased.
Danish: Almindelige (kan forekomme hos 1 til 10 ud af 100 personer) Nedsat appetit, ængstelse eller forværret ængstelse, hallucinationer, ude af stand til at falde i søvn eller blive ved med at sove, ophidselse, desorientering, depression eller forværret depression, nervøsitet, humørsvingninger, ændringer i den mentale tilstand (unormal tænkemåde, forvirring), paranoia, irritabilitet, øget forvirring, vanskelighed ved at lære, huske eller tænke, nedsatte eller manglende reflekser, problemer med at udtrykke eller forstå ord, sløret tale, vanskelighed ved at tale eller tab af evnen til at tale, sløvhed, nedsat balance eller koordination, brændende fornemmelse, øget unormal følelse, nedsat bevidsthedsniveau (ingen respons eller næsten bevistløs), sedation, vanskelighed ved at koncentrere sig, problemer med lugtesansen, mærkelig eller ingen smagssans, rystelse, prikkende og stikkende fornemmelse, dobbeltsyn, synsforstyrrelse, overfølsomhed over for lys, tinnitus (ringetone i ørerne), svimmelhed eller en fornemmelse af at alting kører rundt, omtågethed eller svimmelhed når man står op, lavt blodtryk, kortåndethed, tør mund, smerte i mellemgulvet, forværret kvalme, diaré, forstoppelse, svedafsondring, kløe, muskelsvaghed, muskelspasmer, muskelkrampe, smerte i muskler eller led, vanskelighed ved eller smertefuld vandladning, vanskelighed ved at starte eller kontrollere urinering, følelse af nervøsitet, tendens til at falde, smerte eller forværret smerte, træthed, følelse af kulde, hævelse i ansigt, ben eller fødder, smerte i bryst, ændringer i blodkemien, nedsat mental funktion og vægttab.
English: Pumps previously used to deliver other medicinal products must be washed out three times with sodium chloride 9 mg/ml (0.9%) solution for injection (preservative-free) before being filled with Prialt.
Danish: Pumper, der tidligere er anvendt til at indgive andre lægemidler med, skal gennemskylles tre gange med natriumchlorid injektionsvæske, opløsning, 9 mg/ml (0,9 %) (uden konserveringsmiddel), inden de påfyldes Prialt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 25 micrograms ziconotide (as acetate) Each vial contains 500 micrograms ziconotide (as acetate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml indeholder 25 mikrogram ziconotid (som acetat) Hvert hætteglas indeholder 500 mikrogram ziconotid (som acetat).
English: - Each 1 ml vial contains 100 micrograms; each 2 ml vial contains 200 micrograms; each 5 ml vial contains 500 micrograms.
Danish: - Hvert 1 ml hætteglas indeholder 100 mikrogram; hvert 2 ml hætteglas indeholder
English: LIST OF EXCIPIENTS methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.
Danish: LISTE OVER HJÆLPESTOFFER methionin, natriumchlorid, vand til injektionsvæsker, saltsyre og natriumhydroxid.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 100 μg ziconotide (as acetate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én ml opløsning indeholder 100 μg ziconotid (som acetat).
English: 100 micrograms /1ml
Danish: 100 mikrogram/1 ml
English: 1 vial of 5 ml 5ml
Danish: 1 hætteglas med 5 ml 5 ml
English: - The other ingredients are methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.
Danish: - Øvrige indholdsstoffer: methionin, natriumchlorid, vand til injektionsvæsker, saltsyre og natriumhydroxid
English: 1 vial of 2 ml 2ml
Danish: 1 hætteglas med 2 ml 2 ml
English: Nervous system disorders dizziness, nystagmus, memory impairment, headache, somnolence dysarthria, amnesia, dysgeusia, tremor, balance impaired, ataxia, aphasia, burning sensation, sedation, paraesthesia, hypoaesthesia, disturbance in attenti on, speech disorder, areflexia, coordination abnorm al, dizziness postural, cognitive disorder, hyperaesthesia, hyporeflexia, ageusia, depressed level of consciousness, dysaesthesia, parosmia, mental impairment incoherence, loss of consciousness, coma, stupor, convulsions, cerebrovascular accident, encephalopathy
Danish: Nervesystemet svimmelhed, nystagmus, svigtende hukommelse, hovedpine, døsighed dysartri, amnesi, dysgeusi, tremor, nedsat balanceevne, ataksi, afasi, brændende fornemmelse, sedation, paræstesi, hypæstesi, opmærksomhedsfor styrrelse, taleforstyrrelse, arefleksi, abnorm koordination, postural svimmelhed, nedsat kognitiv funktion, hyperæstesi, hyporefleksi, ageusi, nedsat bevidsthedsniveau, dysæstesi, parosmi, nedsat mental funktion inkohærens, bevidsthedstab, koma, stupor, krampeanfald, cerebrovaskulær sygdom, encefalopati
English: 1 vial of 20 ml
Danish: 1 hætteglas med 20 ml
English: 200 micrograms/2ml
Danish: 200 mikrogram/2 ml
English: 500 micrograms/5ml
Danish: 500 mikrogram/5 ml
English: Musculoskeletal and connective tissue disorders pain in limb, myalgia, muscle spasms, muscle cramp, muscle weakness, arthralgia, peripheral swelling rhabdomyolysis, myositis, back pain, muscle twitching, neck pain
Danish: Knogler, led, muskler og bindevæv smerte i lemmer, myalgi, muskelspasmer, muskelkrampe, muskelsvaghed, arthralgi, perifer hævelse rabdomyolyse, myositis, rygsmerte, muskelkrampe, nakkesmerte
English: EU/1/04/302/003 - 5 ml solution for infusion.
Danish: EU/1/04/302/003 - 5 ml infusionsvæske, opløsning.
English: Each ml contains 100 micrograms ziconotide (as acetate) Each vial contains 500 micrograms ziconotide (as acetate).
Danish: Hver ml indeholder 100 mikrogram ziconotid (som acetat) Hvert hætteglas indeholder 100 mikrogram ziconotid (som acetat).
English: - One ml solution contains 25 micrograms ziconotide (as acetate).
Danish: - Én ml opløsning indeholder 25 mikrogram ziconotid (som acetat).
English: No formal studies assessing the impact of renal or hepatic dysfunction have been conducted; however, given that peptidases are present in various body organs, it is not anticipated that renal or hepatic dysfunction will significantly impact systemic exposure of ziconotide.
Danish: Dog forventes det ikke, at nedsat nyre- eller leverfunktion vil påvirke den systemiske eksponering af ziconotid signifikant, da peptidaser er til stede i forskellige organer i kroppen.
English: Each ml contains 100 micrograms ziconotide (as acetate).
Danish: Hver ml indeholder 100 mikrogram ziconotid (som acetat).
English: EU/1/04/302/002 - 2 ml solution for infusion.
Danish: EU/1/04/302/002 - 2 ml infusionsvæske, opløsning.
English: 1 vial of 1 ml 1ml
Danish: 1 hætteglas med 1 ml 1 ml
English: General disorders and administration site conditions gait abnormal, asthenia fatigue, pyrexia, lethargy, oedema peripheral, rigors, fall, chest pain, feeling cold, pain, feeling jittery, pain exacerbated difficulty in walking
Danish: Abnorm gangart, asteni træthed, pyrexia, sløvhed, perifert ødem, kulderystelser, fald, brystsmerte, kuldefornemmelse, smerte, følelse af nervøsitet, smerte forværret gangbesvær
English: If dilution is required, Prialt must be diluted aseptically with preservative-free sodium chloride 9 mg/ml (0.9%) solution for injection before use.
Danish: Hvis der kræves fortynding, skal Prialt inden brug fortyndes aseptisk med ukonserveret natriumchlorid injektionsvæske 9 mg/ml (0,9 %).
English: - If you get any side effects, talk to your doctor.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: - Each 20 ml vial contains 500 micrograms ziconotide (as acetate).
Danish: - Hvert 20 ml hætteglas indeholder 500 mikrogram ziconotid (som acetat).
English: Infection of the blood stream, delirium (feeling of mental confusion), psychotic disorder (abnormal thinking and perceptions), thought disorders, abnormal dreams, incoherence (inability to make sense), loss of consciousness, stupor (unresponsive/difficult to arouse), stroke, encephalopathy (brain disorder), aggressiveness, abnormal heart rhythm, difficulty breathing, indigestion, rash, muscle inflammation, back pain, muscle twitching, neck pain, acute kidney failure, abnormal heart trace measurements (ECG), raised body temperature, difficulty walking.
Danish: Ikke almindelige (kan forekomme hos 1 til 10 ud af 1.000 personer) Infektion i blodet, delirium (følelse af mental konfusion), psykotisk sygdom (unormale tanker og forestillinger), tankeforstyrrelser, unormale drømme, usammenhængende tale og adfærd, bevidsthedstab, koma, stupor (reagerer ikke/svær at vække), slagtilfælde, encefalopati (hjernesygdom), aggressivitet, unormal hjerterytme, åndedrætsbesvær, fordøjelsesbesvær, udslæt, betændelse i muskler, rygsmerter, muskeltrækninger, smerter i nakken, akut nyresvigt, unormal måling af hjertets aktivitet (ekg), forhøjet legemstemperatur, vanskelighed ved at gå.
English: CNS adverse reactions
Danish: CNS-bivirkninger
English: Each 2 ml vial contains 200 μg ziconotide (as acetate).
Danish: Hvert 2 ml hætteglas indeholder 200 μg ziconotid (som acetat).
English: - One ml solution contains 100 micrograms ziconotide (as acetate).
Danish: - Én ml opløsning indeholder 100 mikrogram ziconotid (som acetat).
English: Each 5 ml vial contains 500 μg ziconotide (as acetate).
Danish: Hvert 5 ml hætteglas indeholder 500 μg ziconotid (som acetat).
English: NAME OF THE MEDICINAL PRODUCT Prialt 100 micrograms/ml solution for infusion ziconotide
Danish: LÆGEMIDLETS NAVN Prialt 100 mikrogram/ml infusionsvæske, opløsning ziconotid
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 μg/ml solution for infusion ziconotide
Danish: LÆGEMIDLETS NAVN Prialt 25 μg/ml infusionsvæske, opløsning ziconotid
English: Each 20 ml vial contains 500 μg ziconotide (as acetate).
Danish: Hvert 20 ml hætteglas indeholder 500 μg ziconotid (som acetat).
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 micrograms/ml solution for infusion ziconotide
Danish: LÆGEMIDLETS NAVN Prialt 25 mikrogram/ml infusionsvæske, opløsning ziconotid
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 micrograms/ml solution for infusion
Danish: LÆGEMIDLETS NAVN Prialt 25 mikrogram/ml infusionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT Prialt 100 micrograms/ml solution for infusion
Danish: LÆGEMIDLETS NAVN Prialt 100 mikrogram/ml infusionsvæske, opløsning
English: Each vial contains 200 micrograms ziconotide (as acetate).
Danish: Hvert hætteglas indeholder 200 mikrogram ziconotid (som acetat).
English: Each 1 ml vial contains 100 μg ziconotide (as acetate).
Danish: Hvert 1 ml hætteglas indeholder 100 μg ziconotid (som acetat).
English: What Prialt looks like and contents of the pack Prialt is a solution for infusion (infusion).
Danish: Prialt er en infusionsvæske, opløsning (infusion).
English: Posology
Danish: Intratekal
English: Reporting of side effects If you get any side effects, talk to your doctor.
Danish: - Kontakt lægen, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/302/001 - 1 ml solution for infusion.
Danish: EU/1/04/302/001 - 1 ml infusionsvæske, opløsning.
English: _ _1 Neisseria meningitidis serogroup A polysaccharide* 5 micrograms Neisseria meningitidis serogroup C polysaccharide* 5 micrograms Neisseria meningitidis serogroup W-135 polysaccharide* 5 micrograms Neisseria meningitidis serogroup Y polysaccharide* 5 micrograms *conjugated to tetanus toxoid carrier protein 44 micrograms
Danish: _ _1 Neisseria meningitidis serogruppe A-polysaccharid* 5 mikrogram Neisseria meningitidis serogruppe C-polysaccharid* 5 mikrogram Neisseria meningitidis serogruppe W-135-polysaccharid* 5 mikrogram Neisseria meningitidis serogruppe Y-polysaccharid* 5 mikrogram
English: 10 vials + 10 pre-filled syringes
Danish: 10 hætteglas + 10 fyldte injektionssprøjter
English: 1 vial + 1 prefilled syringe
Danish: 1 hætteglas + 1 fyldt injektionssprøjte
English: 1 vial + 1 prefilled syringe + 2 needles
Danish: 1 hætteglas + 1 fyldt injektionssprøjte + 2 kanyler
English: MA (EU) number (Invented) name
Danish: EMA Nummer
English: Strength Pharmaceutical form
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: Topotecan Teva is given as an infusion lasting 30 minutes every day for five days with a three-week interval between the start of each course.
Danish: Topotecan Teva gives som infusion, der varer 30 minutter, hver dag i fem dage med et interval på tre uger mellem starten på hvert forløb.
English: Other information about Topotecan Teva:
Danish: Andre oplysninger om Topotecan Teva:
English: • metastatic cancer of the ovary (when the cancer has spread to other parts of the body).
Danish: • metastatisk brystcancer (når canceren har bredt sig til andre dele af kroppen).
English: Treatment with Topotecan Teva should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Danish: Behandling med Topotecan Teva bør kun gives under overvågning af en læge med erfaring i anvendelse af kemoterapi.
English: The dose of Topotecan Teva to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Danish: Hvilken dosis Topotecan Teva, der skal anvendes, afhænger af den pågældende kræfttype og patientens vægt og højde.
English: Topotecan Teva topotecan EPAR summary for the public
Danish: Topotecan Teva topotecan EPAR - sammendrag for offentligheden
English: It is also used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Danish: Det anvendes også sammen med cisplatin (et andet lægemiddel mod kræft) til behandling af kvinder med livmoderhalskræft ved tilbagefald af sygdommen efter strålebehandling, og når sygdommen er fremskreden (stadium IVB: kræften har bredt sig fra livmoderhalsen).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Topotecan Teva has been shown to be comparable to Hycamtin.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Topotecan Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig med Hycamtin.
English: The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Teva to Teva Pharma B.V. on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Topotecan Teva til Teva Pharma B.V.
English: The full EPAR for Topotecan Teva can be found here.
Danish: Den fuldstændige EPAR for Topotecan Teva findes her.
English: Topotecan Teva also affects non-cancer cells, which causes side effects.
Danish: Topotecan Teva påvirker også andre celler end kræftcellerne, hvilket medfører bivirkninger.
English: This means that Topotecan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
Danish: Det betyder, at Topotecan Teva er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Hycamtin.
English: No additional studies were needed as Topotecan Teva is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Topotecan Teva er et generisk lægemiddel, der indgives ved infusion og indeholder det samme aktive stof som referencelægemidlet Hycamtin.
English: Topotecan Teva is a concentrate that is made up into a solution for infusion (drip into a vein).
Danish: Topotecan Teva er et koncentrat, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: What are the benefit and risk of Topotecan Teva?
Danish: Hvilken fordel og risiko er der forbundet med Topotecan Teva?
English: When used with cisplatin in cervical cancer, Topotecan Teva is given on days 1, 2 and 3 (with cisplatin given on day 1).
Danish: Når Topotecan Teva anvendes sammen med cisplatin til behandling af livmoderhalskræft, indgives det som en infusion på dag 1, 2 og 3 (cisplatin gives på dag 1).
English: Topotecan Teva is a ‘generic medicine'.
Danish: Topotecan Teva er et ‘generisk lægemiddel'.
English: Because Topotecan Teva is a generic medicine, the company has provided data from the published literature on topotecan.
Danish: Da Topotecan Teva er et generisk lægemiddel, fremlagde virksomheden data fra den offentliggjorte faglitteratur om topotecan.
English: The active substance in Topotecan Teva, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Danish: Det aktive stof i Topotecan Teva, topotecan, er et lægemiddel mod kræft, der tilhører gruppen af ‘topoisomerasehæmmere'.
English: Because Topotecan Teva is a generic medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Topotecan Tevaer et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The Committee recommended that Topotecan Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Topotecan Actavis.
English: Why has Topotecan Teva been approved?
Danish: Hvorfor blev Topotecan Teva godkendt?
English: Topotecan Teva is an anticancer medicine.
Danish: Topotecan Teva er et lægemiddel mod kræft.
English: What is Topotecan Teva?
Danish: Hvad er Topotecan Teva?
English: How has Topotecan Teva been studied?
Danish: Hvordan blev Topotecan Teva undersøgt?
English: It is used when giving the original treatment again is not recommended.
Danish: • småcellet lungecancer, når kræften er kommet tilbage Det anvendes, når det ikke anbefales at fortsætte den oprindelige behandling.
English: How is Topotecan Teva used?
Danish: Hvordan anvendes Topotecan Teva?
English: What is Topotecan Teva used for?
Danish: Hvad anvendes Topotecan Teva til?
English: 1138, Budapest Hungary
Danish: 1138, Budapest Ungarn
English: Baxter Hungary Kft. Népfürdő u. 22.
Danish: Baxter Ungarn Kft. Népfürdö u. 22.
English: Halandri, 152 33 Greece
Danish: Halandri 15233
English: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park,
Danish: Edificio 10 Sintra Business Park,
English: 164 94 Kista
Danish: 16494 Kista Sverige
English: Baxter SPA piazzale dell' industria 2000144-Roma Italy
Danish: Piazzale dell'Industria 20 00144 Roma Italien
English: 00-380 Warsawa, Poland
Danish: Kruczkowskiego 8 st., 00-380 Warszawa, Polen
English: Baxter Healthcare GmbH, Stella-KleinLöw-Weg 15, A1020 Wien, Austria
Danish: Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Østerrike
English: Belgium Baxter SA Bld R Branquart 80 7860 Lessines Belgium
Danish: Luxembourg Baxter S.A. Bd René Branquart 80 B-7860 Lessines Belgia
English: Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia
Danish: Slovenien Baxter d.o.o., Zelezna cesta 18 ,Ljubljana, SI-1000, Slovenien
English: Annex I
Danish: N/A
English: Denmark Baxter A/S, Gydevang 43, DK3450 Allerød,
Danish: Danmark Baxter A/S Gydevang 43
English: Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands
Danish: 3542 CE Utrecht Nederlandene
English: Norfolk IP24 3SE United Kingdom
Danish: Thetford, Norfolk, IP24 3SE Storbritannien
English: B-7860 Lessines Belgium
Danish: Boulevard R. Branquart 80 7680 Lessines Belgia
English: Baxter Healthcare S.A. Moneen Road Castlebar County Mayo IRELAND
Danish: Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Irland
English: 0.0051 % w/v
Danish: 0,0184% w/v 0,0051% w/v
English: 22,7g+5,38g+4,48g+0,184g+0,051g/l
Danish: Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051 g/l
English: 38.6 g/l glucose anhydrate
Danish: 38.6 g/l glukose anhydrat
English: 38,6g+5,38g+4,48g+0,184g+0,051g/l
Danish: Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
English: 13,6g+5,38g+4,48g+0,184g+0,051g/l
Danish: Dianeal PD4 Glucose 13,6g+5,38g+4,48g+0,184g+0,051 g/l
English: EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse
Danish: Extraneal (lcodextrin 7.5%) Solution for peritoneal dialysis
English: 38,6 g/l glucose anhydrate
Danish: 38.6 g/l Glukose anhydrat
English: 13,6 g/l glucose anhydrate
Danish: 13.6 g/l Glukose anhydrat
English: Lithuania Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland
Danish: Rumænien Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Irland
English: HEALTHCARE Ltd., Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford, United Kingdom
Danish: Thetford, Norfolk, IP24 3SE, Storbritannien
English: The standard dose of Clopidogrel Acino Pharma is one 75 mg tablet once a day, taken with or without food.
Danish: Standarddosis af Clopidogrel Acino Pharma er én 75 mg -tablet én gang dagligt med eller uden et måltid.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino Pharma to Acino Pharma GmbH on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Acino Pharma til Acino Pharma GmbH den 21. september 2009.
English: This means that Clopidogrel Acino Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Acino Pharma er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Plavix.
English: Clopidogrel Acino Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel Acino Pharma anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Acino Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Acino Pharma i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: Clopidogrel Acino Pharma can be given to the following groups of patients:
Danish: Clopidogrel Acino Pharma kan gives til følgende patientgrupper:
English: Clopidogrel Acino Pharma clopidogrel EPAR summary for the public
Danish: Clopidogrel Acino Pharma clopidogrel EPAR - sammendrag for offentligheden
English: Other information about Clopidogrel Acino Pharma:
Danish: Andre oplysninger om Clopidogrel Acino Pharma:
English: Because Clopidogrel Acino Pharma 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 Acino Pharma er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.