natgillin/translations-raw huggingface dataset:
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at Corlentor er tilstrækkeligt effektivt til behandling af angina og har en acceptabel sikkerhedsprofil, således at Corlentor kan bruges som alternativ til behandling af patienter med kronisk stabil angina pectoris, som har en normal sinusrytme, og som ikke tager betablokkere.
The Committee for Medicinal products for Human Use (CHMP) concluded that Corlentor has sufficient effectiveness against angina, and an acceptable safety profile, for Corlentor to provide an alternative treatment for patients with chronic stable angina pectoris with normal sinus rhythm who cannot take beta-blockers.
Udvalget vurderede, at fordelene ved Corlentor er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Corlentor.
They decided that Corlentor’ s benefits are greater than its risks and recommended that Corlentor be given marketing authorisation.
Andre oplysninger om Corlentor:
Other information about Corlentor:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Corlentor til Les Laboratoires Servier den 25. oktober 2005.
The European Commission granted a marketing authorisation valid throughout the European Union, for Corlentor to Les Laboratoires Servier on 25 October 2005.
Den Europæiske Offentlige Vurderingsrapport (EPAR) for Corlentor kan ses i sin helhed her.
The full EPAR for Corlentor is available here.
Dette sammendrag blev sidst ajourført i 03- 2006
This summary was last updated in 03-2006
EU- nummer EU/ 1/ 05/ 317/ 001 EU/ 1/ 05/ 317/ 002 EU/ 1/ 05/ 317/ 003 EU/ 1/ 05/ 317/ 004 EU/ 1/ 05/ 317/ 005 EU/ 1/ 05/ 317/ 006 EU/ 1/ 05/ 317/ 007 EU/ 1/ 05/ 317/ 008 EU/ 1/ 05/ 317/ 009 EU/ 1/ 05/ 317/ 010 EU/ 1/ 05/ 317/ 011 EU/ 1/ 05/ 317/ 012 EU/ 1/ 05/ 317/ 013 EU/ 1/ 05/ 317/ 014
EU number EU/ 1/ 05/ 317/ 001 EU/ 1/ 05/ 317/ 002 EU/ 1/ 05/ 317/ 003 EU/ 1/ 05/ 317/ 004 EU/ 1/ 05/ 317/ 005 EU/ 1/ 05/ 317/ 006 EU/ 1/ 05/ 317/ 007 EU/ 1/ 05/ 317/ 008 EU/ 1/ 05/ 317/ 009 EU/ 1/ 05/ 317/ 010 EU/ 1/ 05/ 317/ 011 EU/ 1/ 05/ 317/ 012 EU/ 1/ 05/ 317/ 013 EU/ 1/ 05/ 317/ 014
Særnavn Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor
Invented name Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor
Styrke 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 7. 5 mg 7. 5 mg 7. 5 mg 7. 5 mg 7. 5 mg 7. 5 mg 7. 5 mg
Strength 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg
Lægemiddelform Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett Filmovertrukket tablett
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Emballage Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC) Blisterpakning (alu/ PVC)
Packaging Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC)
Pakningsstørrelse 14 tabletter 28 tabletter 56 tabletter 84 tabletter 98 tabletter 100 tabletter 112 tabletter 14 tabletter 28 tabletter 56 tabletter 84 tabletter 98 tabletter 100 tabletter 112 tabletter
Package size 14 tablets 28 tablets 56 tablets 84 tablets 98 tablets 100 tablets 112 tablets 14 tablets 28 tablets 56 tablets 84 tablets 98 tablets 100 tablets 112 tablets
En filmovertrukken tablet indeholder 5 mg ivabradin (ækvivalent med 5, 390 mg ivabradinhydrochlorid).
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
6. 1.
63.91 mg lactose monohydrate For a full list of excipients, see section 6.1.
Laksefarvet, aflang, filmovertrukken tablet med delekærv på begge sider, mærket med ” 5 ” på den ene side og
Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “ 5 ” on one face and on the other face.
Symptomatisk behandling af kronisk stabilangina pectoris hos patienter med normal sinusrytme, for hvem β- blokkere er kontraindiceret, eller som lider af intolerans over for β- blokkere.
Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.
Til at danne de forskellige doser foreligger de filmovertrukne tabletter i styrker på 5 mg og 7, 5 mg.
For the different doses film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.
Den normalt anbefalede startdosis er 5 mg ivabradin to gange daglig.
The usual recommended starting dose of ivabradine is 5 mg twice daily.
Afhængigt af det terapeutiske respons kan dosis øges til 7, 5 mg to gange daglig efter tre til fire ugers behandling.
After three to four weeks of treatment, the dose may be increased to 7.5 mg twice daily depending on the therapeutic response.
Hvis hjertefrekvensen i hvile permanent falder til under 50 slag/ min, eller hvis patienten får symptomer på bradykardi som fx svimmelhed, træthed, eller hypotension, skal dosis nedsættes, evt. til 2, 5 mg to gange daglig (en halv 5 mg tablet to gange daglig).
If, during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the possible dose of 2.5 mg twice daily (one half 5 mg tablet twice daily).
4. 4).
Treatment must be discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.4).
5. 2).
Tablets must be taken orally twice daily, i. e. once in the morning and once in the evening during meals (see section 5.2).
Ældre patienter Da ivabradin kun er undersøgt hos et begrænset antal patienter på 75 år og derover, bør det overvejes at starte med en lavere dosis hos disse patienter (2, 5 mg to gange daglig, dvs. en halv 5 mg tablet to gange daglig), før dosis om nødvendigt øges.
Elderly Since ivabradine has been studied in a limited number of patients aged 75 years or more, a lower starting dose should be considered for these patients (2.5 mg twice daily i. e. one half 5 mg tablet twice daily) before up-titration if necessary.
5. 2).
Renal insufficiency No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/ min (see section 5.2).
Der foreligger ikke data fra patienter med kreatininclearance under 15 ml/ min.
No data are available in patients with creatinine clearance below 15 ml/ min.
2 Leverinsufficiens Dosisjustering er ikke nødvendig til patienter med mild leverinsufficiens.
2 Hepatic impairment No dose adjustment is required in patients with mild hepatic impairment.
4. 3 og 5. 2).
Ivabradine is contra-indicated for use in patients with severe hepatic insufficiency, since it has not been studied in this population and a large increase in systemic exposure is anticipated (see sections 4.3 and 5.2).
Børn og unge Corlentor bør ikke anvendes til børn og unge p. g. a. manglende dokumentation for sikkerhed og virkning.
Children and adolescents Corlentor is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
6. 1)
- Hypersensitivity to the active substance or to any of the excipients (see section 6.1)
- Hjertefrekvens i hvile under 60 slag/ min før behandlingen
- Resting heart rate below 60 beats per minute prior to treatment
- Kardiogent shock
- Cardiogenic shock
- Akut myokardieinfarkt
- Acute myocardial infarction
- Svær hypotension (< 90/ 50 mmHg)
- Severe hypotension (< 90/ 50 mmHg)
- Svær leverinsufficiens
- Severe hepatic insufficiency
- Syg sinus- syndrom
- Sick sinus syndrome
- Sinuatrialt blok
- Sino-atrial block
NYHA klassifikation af funktionskapacitet ved
- Heart failure patients with NYHA functional classification III-IV due to a lack of data
- Afhængighed af pacemaker
- Pacemaker dependent
- Ustabil angina pectoris
- Unstable angina
- 3. grads AV- blok
- AV-block of 3rd degree
- Kombination med stærke cytochrom P450 3A4- hæmmere som fx azol- antimykotika
- Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals
4. 5 og 5. 2)
(ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2)
4. 6)
- Pregnancy, lactation (see section 4.6)
Hjertearytmier Ivabradin er ikke egnet til behandling eller profylakse af hjertearytmi og vil sandsynligvis være uden effekt i tilfælde af takyarytmi (fx ventrikulær eller supraventrikulær takykardi).
Cardiac arrhythmias Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when a tachyarrhythmia occurs (eg. ventricular or supraventricular tachycardia).
Det anbefales, at patienter, som behandles med ivabradin, kontrolleres regelmæssigt for atrieflimren (kronisk eller paroksystisk), inklusive EKG- registrering, hvis klinisk nødvendigt (fx i tilfælde af accelereret angina, hjertebanken eller uregelmæssig puls).
It is recommended to regularly clinically monitor ivabradine treated patients for the occurrence of atrial fibrillation (sustained or paroxysmal), which should also include ECG monitoring if clinically indicated (e. g. in case of exacerbated angina, palpitations, irregular pulse).
Anvendelse til patienter med 2. grads AV- blok Ivabradin kan ikke anbefales til patienter med 2. grads AV- blok.
Use in patients with AV-block of 2nd degree Ivabradine is not recommended in patients with AV-block of 2nd degree.
Anvendelse til patienter med lav hjertefrekvens Ivabradin må ikke anvendes til patienter, hvis hjertefrekvens i hvile var under 60 slag/ min før behandlingen (se pkt.
Use in patients with a low heart rate Ivabradine must not be initiated in patients with a pre-treatment resting heart rate below 60 beats per minute (see section 4.3).
4. 2).
If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.2).
Kombination med andre midler mod angina pectoris Samtidig anvendelse af ivabradin med hjertefrekvenssænkende calciumantagonister som fx verapamil eller diltiazem kan ikke anbefales (se pkt.
3 Combination with other antianginal therapies Concomitant use of ivabradine with heart rate reducing calcium channel blockers such as verapamil or diltiazem is not recommended (see section 4.5).
Der er ikke sat spørgsmålstegn ved sikkerheden af
No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers such as amlodipine.
5. 1).
Additional efficacy of ivabradine in combination with dihydropyridine calcium channel blockers has not been established (see section 5.1).
Kronisk hjerteinsufficiens Hjerteinsufficiens skal være adækvat kontrolleret, før behandling med ivabradin kommer på tale.
Chronic heart failure Heart failure must be appropriately controlled before considering ivabradine treatment.
4. 3).
The use of ivabradine is contra-indicated in heart failure patients with NYHA functional classification III-IV, due to a lack of data on clinical efficacy and safety (see section 4.3).
Der skal iagttages forsigtighed hos patienter med asymptomatisk venstre ventrikulær dysfunktion og hos patienter med hjerteinsufficiens NYHA- klasse II på grund af det begrænsede antal undersøgte patienter.
Caution is needed in patients with asymptomatic left ventricular dysfunction, as well as in heart failure patients with NYHA functional classification II due to a limited number of patients studied.
Slagtilfælde Anvendelse af ivabradin anbefales ikke umiddelbart efter et slagtilfælde, da der ikke foreligger data for disse tilstande.
Stroke The use of ivabradine is not recommended immediately after a stroke since no data is available in these situations.
5. 1).
Visual function Ivabradine influences on retinal function (see section 5.1).
Patienter med hypotension Der foreligger kun begrænsede data fra patienter med let til moderat hypotension, og ivabradin bør anvendes med forsigtighed til disse patienter.
Patients with hypotension Limited data are available in patients with mild to moderate hypotension, and ivabradine should therefore be used with caution in these patients.
4. 3)
Ivabradine is contra-indicated in patients with severe hypotension (blood pressure < 90/ 50 mmHg) (see section 4.3).
Atrieflimren – hjertearytmier Det er ikke dokumenteret, at der foreligger en risiko for (voldsom) bradykardi ved genoprettelse af sinusrytme efter indledning af farmakologisk kardiovertering hos patienter, der får ivabradin.
Atrial fibrillation - Cardiac arrhythmias There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine.
Da datamængden imidlertid ikke er omfattende, bør ikke- akut DC- kardiovertering overvejes inden for et døgn efter sidste dosis af ivabradin.
However, in the absence of extensive data, non urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.
4. 5).
Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5).
Hvis kombinationen bliver nødvendig, skal hjertefunktionen monitoreres omhyggeligt.
If the combination appears necessary, close cardiac monitoring is needed.
4. 2)
Use in patients with moderate hepatic insufficiency Caution should be exercised when using ivabradine in patients with moderate hepatic insufficiency (see section 4.2).
4. 2).
Use in patients with severe renal insufficiency Caution should be exercised when using ivabradine in patients with severe renal insufficiency (creatinine clearance < 15 ml/ min) (see section 4.2).
Hjælpestoffer Da tabletterne indeholder lactose, må patienter med sjældne arvelige problemer med galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp lactase deficiency), eller glucose- galactosemalabsorption ikke tage dette lægemiddel.
Excipients Since tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Samtidig anvendelse anbefales ikke QT- forlængende lægemidler
Concomitant use not recommended QT prolonging medicinal products
- Kardiovaskulære QT- forlængende lægemidler (fx chinidin, disopyramid, bepridil, sotalol, ibutilid
- Cardiovascular QT prolonging medicinal products (e. g. quinidine, disopyramide, bepridil, sotalol,
eller amiodaron)
ibutilide, amiodarone).
- Non- kardiovaskulære QT- forlængende lægemidler (fx pimozid, ziprasidon, sertindol, mefloquin,
- Non cardiovascular QT prolonging medicinal products (e. g. pimozide, ziprasidone, sertindole,
halofantrin, pentamidin, cisaprid og erythromycin i. v.) Samtidig anvendelse af kardiovaskulære og non- kardiovaskulære QT- forlængende lægemidler med ivabradin bør dog undgås, da QT- forlængelsen kan forstærkes ved reduktion af hjertefrekvensen.
The concomitant use of cardiovascular and non cardiovascular QT prolonging medicinal products with ivabradine should be avoided since QT prolongation may be exacerbated by heart rate reduction.
4. 4).
If the combination appears necessary, close cardiac monitoring is needed (see section 4.4).
Cytokrom P450 3A4 (CYP3A4) Ivabradin metaboliseres kun af CYP3A4 og er en meget svag hæmmer af dette cytokrom.
Cytochrome P450 3A4 (CYP3A4) Ivabradine is metabolised by CYP3A4 only and it is a very weak inhibitor of this cytochrome.
Det er påvist, at ivabradin ikke påvirker metabolismen og plasmakoncentrationerne af andre CYP3A4 - substrater (svage, moderate og stærke hæmmere).
Ivabradine was shown not to influence the metabolism and plasma concentrations of other CYP3A4 substrates (mild, moderate and strong inhibitors).
Lægemiddelinteraktionsstudier har vist, at CYP3A4- hæmmere øger plasmakoncentrationen af ivabradin, mens induktorer nedsætter den.
Drug-drug interaction studies have established that CYP3A4 inhibitors increase ivabradine plasma concentrations, while inducers decrease them.
4. 4).
Increased plasma concentrations of ivabradine may be associated with the risk of excessive bradycardia (see section 4.4).
4. 3).
Contra-indication of concomitant use The concomitant use of potent CYP3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contra-indicated (see section 4.3).
De stærke CYP3A4- hæmmere ketoconazol (200 mg en gang daglig) og josamycin (1 g to gange daglig) øgede den gennemsnitlige plasmaeksponering for ivabradin 7- 8 gange.
The potent CYP3A4 inhibitors ketoconazole (200 mg once daily) and josamycin (1 g twice daily) increased ivabradine mean plasma exposure by 7 to 8 fold.
Samtidig anvendelse anbefales ikke Moderate CYP3A4- hæmmere: specifikke interaktionsstudier hos raske frivillige og patienter har vist, at kombinationen af ivabradin med de hjertefrekvenssænkende stoffer diltiazem eller verapamil medførte en øgning af eksponeringen overfor ivabradin (to til tre gange øgning af AUC) samt en yderligere reduktion af hjertefrekvensen på 5 slag/ min.
Concomitant use not recommended Moderate CYP3A4 inhibitors: specific interaction studies in healthy volunteers and patients have shown that the combination of ivabradine with the heart rate reducing agents diltiazem or verapamil resulted in an increase in ivabradine exposure (2 to 3 fold increase in AUC) and an additional heart rate reduction of 5 bpm.
4. 4).
The concomitant use of ivabradine with these medicinal products is not recommended (see section 4.4).
Samtidig anvendelse af ivabradin og andre moderate CYP3A4 -
- Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4
hæmmere (fx fluconazol) kan overvejes med en startdosis på 2, 5 mg to gange daglig og kontrol af hjertefrekvensen, hvis hjertefrekvensen i hvile er over 60 slag/ min.).
inhibitors (e. g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 60 bpm, with monitoring of heart rate.
Eksponeringen over for ivabradin blev øget med en faktor 2 efter samtidig
- Grapefruit juice: ivabradine exposure was increased by 2-fold following the co-administration with
administration med grapefrugtjuice.
grapefruit juice.
Indtagelsen af grapefrugtjuice skal derfor begrænses under behandling med ivabradin.
Therefore the intake of grapefruit juice should be restricted during the treatment with ivabradine.
- CYP3A4- induktorer:
- CYP3A4 inducers:
CYP3A4- induktorer (fx rifampicin, barbiturater, phenytoin, Hypericum
CYP3A4 inducers (e. g. rifampicin, barbiturates, phenytoin, Hypericum
perforatum [prikbladet perikon]) kan nedsætte eksponeringen over for ivabradin og aktiviteten af ivabradin.
perforatum [St John’ s Wort]) may decrease ivabradine exposure and activity.
Samtidig anvendelse af CYP3A4- induktorer kan nødvendiggøre dosisjustering af ivabradin.
The concomitant use of CYP3A4 inducing medicinal products may require an adjustment of the dose of ivabradine.
Det er vist, at kombinationen af 10 mg ivabradin to gange daglig med prikbladet perikon nedsætter ivabradin- AUC til det halve.
The combination of ivabradine 10 mg twice daily with St John’ s Wort was shown to reduce ivabradine AUC by half.
Indtagelse af prikbladet perikon skal begrænses under behandling med ivabradin.
The intake of St John’ s Wort should be restricted during the treatment with ivabradine.
Syrepumpehæmmere (omeprazol, lansoprazol), sildefanil, HMG- CoA- reduktasehæmmere (simvastatin), dihydropyridin -
5 Other concomitant use Specific drug-drug interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG CoA reductase inhibitors (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin.
Angiotensin I - konverteringshæmmere, angiotensin II- konverteringsantagonister, diuretika, kort - og langtidsvirkende nitratpræparater, HMG- CoA- reduktasehæmmere, fibrater, syrepumpehæmmere, perorale antidiabetika, acetylsalicylsyre og andre trombocytfunktionshæmmende stoffer.
In pivotal phase III clinical trials the following medicinal products were not restricted and therefore were routinely combined with ivabradine with no evidence of safety concerns: angiotensin converting enzyme inhibitors, angiotensin II antagonists, diuretics, short and long acting nitrates, HMG CoA reductase inhibitors, fibrates, proton pump inhibitors, oral antidiabetics, aspirin and other anti-platelet agents.
Der findes ingen adækvate data om anvendelsen af ivabradin til gravide kvinder.
There are no adequate data concerning the use of ivabradine in pregnant women.
5. 3).
Animal reproduction studies have shown embryotoxic and teratogenic effects (see section 5.3).
Ivabradin er derfor kontraindiceret under graviditet.
Therefore, ivabradine is contra-indicated during pregnancy.
Dyreforsøg tyder på, at ivabradin udskilles i modermælk.
Animal studies indicate that ivabradine is excreted in milk.
Ivabradin er derfor kontraindiceret i ammeperioden.
Therefore, ivabradine is contra-indicated in breast-feeding women.
Der var ingen tegn på ændringer i evnen til at køre bil.
A specific study to assess the possible influence of ivabradine on driving performance has been performed in healthy volunteers where no alteration of the driving performance was evidenced.
Ivabradin påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
Ivabradine has no influence on the ability to drive and use machines.
4. 8).
However, ivabradine may cause transient luminous phenomena consisting mainly of phosphenes (see section 4.8).
Corlentor er blevet undersøgt i kliniske studier omfattende næsten 5000 deltagere.
Corlentor has been studied in clinical trials involving nearly 5,000 participants.
Omkring 2900 patienter er blevet behandlet med ivabradin i fase II- III studier.
Approximately 2,900 patients have been treated with ivabradine in phase II-III studies.
De almindeligste bivirkninger efter ivabradin er dosisafhængige og relateret til lægemidlets farmakologiske effekt.
The most common undesirable effects with ivabradine are dose dependent and related to the pharmacological effect of the medicinal product.