FrancophonIA/ELRC3.0 huggingface dataset:
English: No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat nyrefunktion (GFR >30 ml/min/1,73 m2).
English: Exforge was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Danish: Exforge er også undersøgt i et aktivt kontrolleret studie med 130 hypertensive patienter med middel siddende diastolisk blodtryk ≥110 mmHg og <120 mmHg.
English: Clinically significant hypotension due to Exforge overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Danish: Klinisk signifikant hypotension pga. overdosering med Exforge kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
English: Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Danish: Exforge kombinerer to antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: amlodipin tilhører klassen kaldet calciumantagonister og valsartan tilhører klassen kaldet angiotensin II-antagonister.
English: If hypotension occurs with Exforge, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Danish: Hvis der forekommer hypotension med Exforge, skal patienten placeres i liggende rygstilling, og om nødvendigt skal der gives intravenøs infusion af isotonisk natriumchlorid.
English: Patients taking Exforge and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Danish: Patienter, som fører motorkøretøj eller betjener maskiner under behandling med Exforge, skal være opmærksomme på, at der lejlighedsvis kan optræde svimmelhed eller træthed.
English: Following oral administration of Exforge, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Danish: Efter oral administration af Exforge opnås maksimal plasmakoncentration for valsartan og amlodipin efter henholdsvis 3 timer og 6-8 timer.
English: What you need to know before you take Exforge
Danish: Det skal du vide, før du begynder at tage Exforge
English: Talk to your doctor before taking Exforge: if you have been sick (vomiting or diarrhoea).
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Exforge: - hvis du har været syg (opkastning eller diarré).
English: If any of the above applies to you, do not take Exforge and talk to your doctor.
Danish: Hvis noget af ovenstående gælder for dig, må du ikke tage Exforge, og du skal kontakte din læge.
English: Pharyngolaryngeal pain Uncommon Rhinitis
Danish: Faryngolaryngeale smerter Ikke almindelig Rhinitis
English: The safety and efficacy of Exforge in children aged below 18 years have not been established.
Danish: Pædiatrisk population Exforges sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: If you stop taking Exforge
Danish: Hvis du holder op med at tage Exforge
English: Exforge is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Danish: Exforge er tilgængelig i pakninger indholdende 7, 14, 28, 30, 56, 90, 98 eller 280 tabletter og multipakninger, bestående af 4 kartoner med hver 70 tabletter, eller 20 kartoner med hver 14 tabletter.
English: What Exforge contains
Danish: Exforge indeholder:
English: If you forget to take Exforge
Danish: Hvis du har glemt at tage Exforge
English: Orthostatic hypotension Uncommon Vasculitis
Danish: Sjælden Ikke almindelig Ortostatisk hypotension Ikke almindelig Vaskulitis
English: There are no clinical studies on fertility with Exforge.
Danish: Der er ikke udført fertilitetsstudier med Exforge.
English: Particular caution should be exercised when administering Exforge to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Danish: Der bør udvises særlig forsigtighed, når Exforge gives til patienter med let til moderat nedsat leverfunktion eller biliære obstruktive lidelser.
English: Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young, therefore caution is required when increasing the dosage.
Danish: Middel systemisk AUC af valsartan er 70% højere hos ældre end hos yngre.
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Exforge in placebo-controlled studies.
Danish: Under placebokontrollerede studier blev der set udtalt hypotension hos 0,4% af patienterne med ukompliceret hypertension, som blev behandlet med Exforge.
English: In elderly patients, caution is required when increasing the dosage.
Danish: Der skal udvises forsigtighed, når dosis øges til ældre patienter.
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Exforge containing the same component doses.
Danish: Patienter, som får valsartan og amlodipin fra hver sin tablet/kapsel, kan for nemhedens skyld skifte til Exforge med den samme dosis af hver komponent.
English: The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-delen af Exforge hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: If any of these apply to you, tell your doctor before taking Exforge.
Danish: Hvis dette gælder for dig, så tal med din læge inden du tager Exforge.
English: Side effects reported with amlodipine or valsartan alone and either not observed with Exforge or observed with a higher frequency than with Exforge:
Danish: Bivirkninger, som er rapporteret ved behandling med valsartan og amlodipin alene, og som enten ikke er set ved behandling med Exforge, eller som er set hyppigere end ved behandling med Exforge:
English: • Concomitant use of Exforge with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: • Samtidig brug af Exforge og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: Other medicines and Exforge
Danish: Brug af anden medicin sammen med Exforge
English: Exforge is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Danish: Exforge er indiceret til voksne, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin eller valsartan monoterapi.
English: Other possible side effects of Exforge:
Danish: Andre bivirkninger ved brug af Exforge
English: Hepatic impairment Exforge is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Nedsat leverfunktion Exforge er kontraindiceret hos patienter med alvorligt nedsat leverfunktion (se pkt.
English: Very rare* Not known
Danish: Meget sjælden* Ikke kendt
English: Uncommon Very rare Uncommon
Danish: Ikke almindelig Meget sjælden Ikke almindelig
English: Exforge is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Danish: Exforge bruges til at behandle forhøjet blodtryk hos voksne, som ikke kan få deres blodtryk passende kontrolleret med enten amlodipin eller valsartan alene.
English: Caution should be exercised when administering Exforge to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Danish: Der skal udvises forsigtighed, når Exforge gives til patienter med nedsat leverfunktion eller biliære obstruktive lidelser (se pkt.
English: ACE inhibitors or aliskiren (see also information under the headings “Do not take Exforge” and “Warnings and precautions”); diuretics (a type of medicine also called “water tablets” which increases the amount of urine you produce); lithium (a medicine used to treat some types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Danish: Det gælder især for den medicin, som er beskrevet herunder: - hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Exforge” og ”Advarsler og forsigtighedsregler”); - diuretika (en type medicin, som også kaldes ”vanddrivende tabletter”, og som forhøjer den mængde urin, du producerer); - medicin til behandling af visse typer depression (lithium); - kaliumbesparende diuretika, kaliumtilskud, salterstatninger, som indeholder kalium eller andre stoffer, der kan øge indholdet af kalium i blodet; - en bestemt type smertestillende medicin, som kaldes non-steroide anti-inflammatoriske lægemidler (NSAID'er) eller selektive cyclooxygenase-2-hæmmere (COX-2-hæmmere).
English: Grapefruit and grapefruit juice should not be consumed by people who are taking Exforge.
Danish: Du må ikke indtage grapefrugt og grapefrugtjuice, mens du tager Exforge.
English: This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Exforge.
Danish: Det skyldes, at grapefrugt og grapefrugtjuice kan føre til en øget mængde af det aktive stof, amlodipin, i blodet.
English: (It is also better to avoid Exforge in early pregnancy, see Pregnancy section).
Danish: - hvis du er mere end 3 måneder henne i graviditeten (brug af Exforge tidligt i graviditeten bør også undgås, se afsnittet om Graviditet).
English: In this study (baseline blood pressure 171/113 mmHg), an Exforge regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Danish: I dette studie (baseline blodtryk 171/113 mmHg) nedsatte Exforge 5 mg/160 mg titreret op til 10 mg/160 mg blodtrykket i siddende stilling med 36/29 mmHg.
English: Exforge 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Exforge 5 mg/160 mg.
Danish: Exforge 10 mg/160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 10 mg eller valsartan 160 mg alene eller med Exforge 5 mg/160 mg.
English: Exforge 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Danish: Exforge 5 mg/80 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 80 mg alene.
English: How to take Exforge
Danish: Sådan skal du tage Exforge
English: Exforge can be used with or without food.
Danish: Exforge kan tages uden hensyn til fødeindtagelse.
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Exforge, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Danish: 4.1) med nedsat leverfunktion skiftes til amlodipin eller Exforge, skal den laveste tilgængelige dosis af henholdvis amlodipin-monoterapi eller amlodipinkombination anvendes.
English: Exforge 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Danish: Exforge 10 mg/160 mg tabletter er ovale og lysegule, præget med ”NVR” på den ene side og ”UIC” på den anden side.
English: Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets
Danish: Exforge 5 mg/80 mg filmovertrukne tabletter Exforge 5 mg/160 mg filmovertrukne tabletter Exforge 10 mg/160 mg filmovertrukne tabletter
English: Rare (may affect up to 1 in 1,000 people): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light headedness; excessive sweating; skin rash all over your body; itching; muscle spasm.If any of these affect you severely, tell your doctor.
Danish: Sjældne (kan forekomme hos op til 1 ud af 1.000 personer): Angstfølelse; ringen for ørene (tinnitus); besvimelse; større urinproduktion end normalt eller forøget trang til vandladning; manglende evne til at få eller vedholde erektion; følelsen af tunghed; for lavt blodtryk med symptomer som svimmelhed, uklarhed; øget svedtendens; hududslæt over hele kroppen, kløe, muskelkramper.
English: Exforge 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Danish: Exforge 5 mg/160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 160 mg alene.
English: Exforge 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Danish: Exforge 5 mg/160 mg tabletter er ovale og mørkegule, præget med ”NVR” på den ene side og ”ECE” på den anden side.
English: No information is available regarding the use of Exforge during breast-feeding, therefore Exforge is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Danish: I stedet foretrækkes alternative behandlinger med bedre dokumenterede sikkerhedsprofiler ved amning, især ved amning af et nyfødt spædbarn eller et for tidligt født spædbarn.
English: Exforge 5 mg/80 mg film-coated tablets
Danish: Exforge 5 mg/80 mg filmovertrukne tabletter
English: Exforge 10 mg/160 mg film-coated tablets
Danish: Exforge 10 mg/160 mg filmovertrukne tabletter
English: Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Exforge 5 mg/80 mg filmovertrukne tabletter Exforge 5 mg/160 mg filmovertrukne tabletter Exforge 10 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: Exforge 5 mg/160 mg film-coated tablets
Danish: Exforge 5 mg/160 mg filmovertrukne tabletter
English: Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Exforge 10 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: EU/1/06/370/035 280 film-coated tablets (4x70) EU/1/06/370/038 280 film-coated tablets (20x14)
Danish: EU/1/06/370/035 280 filmovertrukne tabletter (4x70) EU/1/06/370/038 280 filmovertrukne tabletter (20x14)
English: EU/1/06/370/034 280 film-coated tablets (4x70) EU/1/06/370/037 280 film-coated tablets (20x14)
Danish: EU/1/06/370/034 280 filmovertrukne tabletter (4x70) EU/1/06/370/037 280 filmovertrukne tabletter (20x14)
English: EU/1/06/370/036 280 film-coated tablets (4x70) EU/1/06/370/039 280 film-coated tablets (20x14)
Danish: EU/1/06/370/036 280 filmovertrukne tabletter (4x70) EU/1/06/370/039 280 filmovertrukne tabletter (20x14)
English: What Exforge looks like and contents of the pack Exforge 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Danish: Exforge 5 mg/80 mg tabletter er runde og mørkegule, præget med ”NVR” på den ene side og ”NV” på den anden side.
English: Exforge 5 mg/80 mg film-coated tablets amlodipine/valsartan
Danish: Exforge 5 mg/80 mg filmovertrukne tabletter amlodipin/valsartan
English: Uncommon Uncommon Not known
Danish: Ikke almindelig Ikke almindelig Ikke kendt
English: Exforge 5 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Exforge 5 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced coughing, compared to 68.5% of those treated with an ACE inhibitor (p <0.05).
Danish: Til sammenligning oplevede 68,5% af patienterne, som blev behandlet med en ACE-hæmmer, hoste (p <0,05).
English: EU/1/06/370/001 7 film-coated tablets EU/1/06/370/002 14 film-coated tablets EU/1/06/370/003 28 film-coated tablets EU/1/06/370/004 30 film-coated tablets EU/1/06/370/005 56 film-coated tablets EU/1/06/370/006 90 film-coated tablets EU/1/06/370/007 98 film-coated tablets EU/1/06/370/008 280 film-coated tablets EU/1/06/370/025 56x1 film-coated tablet (unit dose) EU/1/06/370/026 98x1 film-coated tablet (unit dose) EU/1/06/370/027 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/370/001 7 filmovertrukne tabletter EU/1/06/370/002 14 filmovertrukne tabletter EU/1/06/370/003 28 filmovertrukne tabletter EU/1/06/370/004 30 filmovertrukne tabletter EU/1/06/370/005 56 filmovertrukne tabletter EU/1/06/370/006 90 filmovertrukne tabletter EU/1/06/370/007 98 filmovertrukne tabletter EU/1/06/370/008 280 filmovertrukne tabletter EU/1/06/370/025 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/026 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/027 280x1 filmovertrukket tablet (enhedsdosis)
English: EU/1/06/370/017 7 film-coated tablets EU/1/06/370/018 14 film-coated tablets EU/1/06/370/019 28 film-coated tablets EU/1/06/370/020 30 film-coated tablets EU/1/06/370/021 56 film-coated tablets EU/1/06/370/022 90 film-coated tablets EU/1/06/370/023 98 film-coated tablets EU/1/06/370/024 280 film-coated tablets EU/1/06/370/031 56x1 film-coated tablet (unit dose) EU/1/06/370/032 98x1 film-coated tablet (unit dose) EU/1/06/370/033 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/370/017 7 filmovertrukne tabletter EU/1/06/370/018 14 filmovertrukne tabletter EU/1/06/370/019 28 filmovertrukne tabletter EU/1/06/370/020 30 filmovertrukne tabletter EU/1/06/370/021 56 filmovertrukne tabletter EU/1/06/370/022 90 filmovertrukne tabletter EU/1/06/370/023 98 filmovertrukne tabletter EU/1/06/370/024 280 filmovertrukne tabletter EU/1/06/370/031 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/032 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/033 280x1 filmovertrukket tablet (enhedsdosis)
English: EU/1/06/370/009 7 film-coated tablets EU/1/06/370/010 14 film-coated tablets EU/1/06/370/011 28 film-coated tablets EU/1/06/370/012 30 film-coated tablets EU/1/06/370/013 56 film-coated tablets EU/1/06/370/014 90 film-coated tablets EU/1/06/370/015 98 film-coated tablets EU/1/06/370/016 280 film-coated tablets EU/1/06/370/028 56x1 film-coated tablet (unit dose) EU/1/06/370/029 98x1 film-coated tablet (unit dose) EU/1/06/370/030 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/370/009 7 filmovertrukne tabletter EU/1/06/370/010 14 filmovertrukne tabletter EU/1/06/370/011 28 filmovertrukne tabletter EU/1/06/370/012 30 filmovertrukne tabletter EU/1/06/370/013 56 filmovertrukne tabletter EU/1/06/370/014 90 filmovertrukne tabletter EU/1/06/370/015 98 filmovertrukne tabletter EU/1/06/370/016 280 filmovertrukne tabletter EU/1/06/370/028 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/029 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/030 280x1 filmovertrukket tablet (enhedsdosis)
English: If you take more Exforge than you should
Danish: Hvis du har taget for meget Exforge
English: Exforge is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Dette er især vigtigt, hvis dit barn er nyfødt eller blev født for tidligt.
English: What Exforge is and what it is used for What you need to know before you take Exforge How to take Exforge
Danish: Det skal du vide, før du begynder at tage Exforge Sådan skal du tage Exforge Bivirkninger
English: This summary was last updated in 02-2012.
Danish: Dette sammendrag blev sidst ajourført i 01-2016.
English: The full EPAR for Clopidogrel Acino can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Clopidogrel Acino findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino on 28 July 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Acino den 28. juli 2009.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Acino.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Clopidogrel Acino.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel Acino.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel Acino.
English: For more information about treatment with Clopidogrel Acino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel Acino, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Danish: Dette efterfølges så af en standarddosis på 75 mg en gang dagligt i mindst fire uger (ved myokardieinfarkt med "STsegmentelevation") eller i op til 12 måneder (ved ustabil angina eller "non-Q-tak" myokardieinfarkt).
English: • patients who have recently had a myocardial infarction (heart attack).
Danish: • for nylig har haft et myokardieinfarkt (hjertetilfælde).
English: The standard dose of Clopidogrel Acino is one 75 mg tablet once a day.
Danish: Standarddosis af Clopidogrel Acino er en tablet på 75 mg en gang dagligt.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Danish: • har perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne)
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Acino has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Clopidogrel Acino er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: This means that Clopidogrel Acino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Acino er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, og som hedder Plavix.
English: Clopidogrel Acino can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel Acino kan påbegyndes mellem få dage og indtil 35 dage efter anfaldet
English: • patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Danish: • for nylig har haft et iskæmisk slagtilfælde (et slagtilfælde forårsaget af manglende blodforsyning til en del af hjernen).
English: Clopidogrel Acino is a ‘generic medicine'.
Danish: Clopidogrel Acino er et "generisk lægemiddel".