natgillin/translations-raw huggingface dataset:
This means that Fyzoclad was intended to be highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
To pomeni, da naj bi bilo zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je v EU že odobreno.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was due to a change in the company's strategy.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je vlogo umaknila zaradi spremembe v svoji strategiji.
On 5 December 2018, Pfizer Europe MA EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fyzoclad, for the treatment of a number of inflammatory diseases.
Družba Pfizer Europe MA EEIG je 5. decembra 2018 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Fyzoclad, namenjenim zdravljenju več vnetnih bolezni.
As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Ker je odbor CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.
The company informed the CHMP that there are no ongoing clinical trials with Fyzoclad.
Družba je odbor CHMP obvestila, da trenutno ne potekajo nobena klinična preskušanja z zdravilom Fyzoclad.
Withdrawal of the marketing authorisation application for Fyzoclad (adalimumab)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fyzoclad (adalimumab)
The application was withdrawn while the CHMP was still evaluating the initial documentation provided by the company.
Vlogo so umaknili, ko je odbor CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba.
By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Adalimumab z vezavo na TNF zavre njegovo delovanje ter tako zmanjša vnetje in druge simptome bolezni.
It was to be available as a solution for injection.
Na voljo naj bi bilo v obliki raztopine za injiciranje.
Withdrawal of the marketing authorisation application for Fyzoclad (adalimumab) EMA/866697/2018
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fyzoclad (adalimumab) EMA/10639/2019
This substance is involved in causing inflammation associated with the diseases that adalimumab is intended to treat and is found at high levels in patients with these diseases.
Ta snov sodeluje pri povzročanju vnetja, povezanega z boleznimi, ki naj bi jih adalimumab zdravil, in je pri bolnikih s temi boleznimi prisotna v večjih količinah.
Fyzoclad acts on the immune system and was to be used to treat the following inflammatory conditions:
Zdravilo Fyzoclad deluje na imunski sistem in naj bi se uporabljalo za zdravljenje naslednjih vnetnih bolezni:
Fyzoclad is a medicine that contains the active substance adalimumab.
Fyzoclad je zdravilo, ki vsebuje učinkovino adalimumab.
13 December 2018
13. december 2018 EMA/10639/2019
Fyzoclad was expected to work in the same way as the reference medicine, Humira.
Zdravilo Fyzoclad naj bi delovalo na enak način kot referenčno zdravilo Humira.
Fyzoclad was developed as a ‘biosimilar' medicine.
Zdravilo Fyzoclad je bilo razvito kot „podobno biološko zdravilo“.
• uveitis (inflammation of the layer beneath the white of the eyeball) and paediatric uveitis.
• uveitisa (vnetja sloja pod beločnico očesa) in pediatričnega uveitisa.
What was Fyzoclad expected to be used for?
Za kaj naj bi se zdravilo Fyzoclad uporabljalo?
The reference medicine for Fyzoclad is Humira.
Referenčno zdravilo za zdravilo Fyzoclad je zdravilo Humira.
The company presented laboratory studies comparing Fyzoclad to its reference medicine Humira in terms of structure, purity and biological activity.
Družba je predložila laboratorijske študije, v katerih so zgradbo, čistost in biološko delovanje zdravila Fyzoclad primerjali z referenčnim zdravilom Humira.
• psoriasis and paediatric plaque psoriasis (both are diseases causing red, scaly patches on the skin).
• psoriaze in pediatrične psoriaze v plakih (bolezni, ki povzročata nastajanje rdečih, luskastih zaplat na koži);
How does Fyzoclad work?
Kako zdravilo Fyzoclad deluje?
In addition, a study in patients with rheumatoid arthritis compared Fyzoclad with Humira.
Poleg tega so zdravili Fyzoclad in Humira primerjali tudi v študiji pri bolnikih z revmatoidnim artritisom.
• axial spondyloarthritis (inflammation of the spine causing back pain);
• aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu);
What is Fyzoclad?
Kaj je zdravilo Fyzoclad?
• juvenile idiopathic arthritis (disease causing inflammation in the joints);
• juvenilnega idiopatskega artritisa (bolezni, ki povzroča vnetje sklepov);
been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Učinkovina zdravila Fyzoclad, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna snov, imenovano tumorje nekrotizirajoči faktor (TNF), in se veže nanjo.
• psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
• psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih in luskastih lis na koži in vnetje sklepov);
Children Procoralan is not intended for use in children and adolescents younger than 18 years.
Otroci Procoralan ni namenjen za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
In this way Procoralan helps to control and reduce the number of angina attacks.
Na ta način Procoralan pripomore k nadzoru in zmanjševanju anginoznih napadov.
If you forget to take a dose of Procoralan, take the next dose at the usual time.
Če ste pozabili vzeti odmerek zdravila Procoralan, vzemite naslednji odmerek ob običajnem času.
92284 Suresnes cedex - France
92284 Suresnes cedex- Francija
If you are pregnant and have taken Procoralan, talk to your doctor.
Če ste noseči in ste jemali zdravilo Procoralan, se posvetujte z zdravnikom.
The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Procoralan.
Koledar, ki je natisnjen na pretisnem omotu s tabletami, vam pomaga, da si zapomnite, kdaj ste nazadnje vzeli tableto zdravila Procoralan.
Procoralan mainly works by reducing the heart rate by a few beats per minute.
Procoralan deluje predvsem tako, da znižuje srčno frekvenco za nekaj utripov na minuto.
The safety and efficacy of ivabradine in children aged below 18 years have not yet been established.
Pediatrična populacija Varnost in učinkovitost ivabradina pri otrocih, mlajših od 18 let, še nista bili dokazani.
What Procoralan is and what it is used for What you need to know before you take Procoralan How to take Procoralan
Kaj je zdravilo Procoralan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Procoralan Kako jemati zdravilo Procoralan
If you think that the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila Procoralan premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Procoralan should be taken during meals.
Zdravilo Procoralan morate jemati med obrokom.
If any of the above applies to you, talk straight away to your doctor before or while taking Procoralan.
Če karkoli od naštetega velja za vas, se takoj pogovorite z zdravnikom pred jemanjem zdravila Procoralan ali med njim.
The European Medicines Agency has deferred the obligation to submit the results of studies with Procoralan in one or more subsets of the paediatric population in the treatment of chronic heart failure (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Procoralan za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega srčnega popuščanja (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Other medicines and Procoralan
Druga zdravila in zdravilo Procoralan
Procoralan may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Procoralan lahko povzroča začasne vidne pojave svetlikanja (prehodno povečanje svetlosti v vidnem polju, glejte “Možni neželeni učinki”).
Elevated creatinine in blood ECG prolonged QT interval
Preiskave občasni povečanje kreatinina v krvi podaljšanje intervala QT na EKG
How does Procoralan work?
Kako deluje zdravilo Procoralan?
Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation:
Ivabradin ne vpliva na znotrajsrčno prevajanje, kontraktilnost (ni negativnega inotropnega učinka) ali repolarizacijo prekatov:
Do not take Procoralan - if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section
Kaj morate vedeti, preden boste vzeli zdravilo Procoralan Ne jemljite zdravila Procoralan če ste alergični na ivabradin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Procoralan 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Nekaterim bolnikom (na primer, če ste starejši) lahko zdravnik predpiše polovični odmerek, se pravi eno polovico 5 mg tablete (kar ustreza 2,5 mg ivabradina) zjutraj in eno polovico 5 mg tablete zvečer.
Procoralan contains lactose
Zdravilo Procoralan vsebuje laktozo.
The starting dose should not exceed one tablet of Procoralan 5 mg twice daily.
Začetni odmerek ne sme presegati ene tablete zdravila Procoralan 5 mg dvakrat na dan.
Do not take Procoralan if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Procoralan”).
Če ste ženska v rodni dobi ne smete jemati zdravila Procoralan, razen če uporabljate zanesljive kontracepcijske metode (glejte “Ne jemljite zdravila Procoralan”).
Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.
Palpitacije in dodatni srčni utripi, občutek slabosti (navzea), zaprtje, driska, bolečina v trebuhu, občutek vrtoglavosti (vertigo), oteženo dihanje (dispneja), mišični krči, spremembe laboratorijskih parametrov: visoke vrednosti sečne kisline v krvi, preveliko število eozinofilcev (vrsta belih krvnih celic) in povečanje kreatinina v krvi (razgradni produkt mišic), kožni izpuščaj, angioedem (kot je otečen obraz, jezik ali grlo, težave pri dihanju ali požiranju), nizek krvni tlak, omedlevica, občutek utrujenosti, občutek šibkosti, nepravilnosti v zapisu EKG srca, dvojni vid, okvara vida.
The usual recommended starting dose is one tablet of Procoralan 5 mg twice daily increasing if necessary to one tablet of Procoralan 7.5 mg twice daily.
Običajen priporočljiv začetni odmerek je ena tableta zdravila Procoralan 5 mg dvakrat na dan, kar lahko povečate na eno tableto zdravila Procoralan 7,5 mg dvakrat na dan, če je potrebno.
If you forget to take Procoralan:
Če ste pozabili vzeti zdravilo Procoralan
INFORMATION IN BRAILLE PROCORALAN 5 mg
PODATKI V BRAILLOVI PISAVI PROCORALAN 5 mg
Do not take Procoralan if you are breast-feeding (see “Do not take Procoralan”).
Ne jemljite zdravila Procoralan, če dojite (glejte “Ne jemljite zdravila Procoralan”).
MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/001-007
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/316/001-007
* Frequency calculated from clinical trials for adverse events detected from spontaneous report
*Pogostnost neželenih učinkov iz spontanega poročanja je izračunana na podlagi podatkov iz kliničnih študij Opis izbranih neželenih učinkov
MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/008-014
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/316/008-014
INFORMATION IN BRAILLE PROCORALAN 7.5 mg
PODATKI V BRAILLOVI PISAVI PROCORALAN 7,5 mg
Procoralan with food and drink Avoid grapefruit juice during treatment with Procoralan.
Med zdravljenjem z zdravilom Procoralan se izogibajte uživanju grenivkinega soka.
How to take Procoralan
Kako jemati zdravilo Procoralan
5 How to store Procoralan Contents of the pack and other information
Shranjevanje zdravila Procoralan Vsebina pakiranja in dodatne informacije
As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Če ste prenehali jemati zdravilo Procoralan Ker je zdravljenje angine pektoris ali kroničnega srčnega popuščanja običajno doživljenjsko, se pred prenehanjem jemanja tega zdravila posvetujte z zdravnikom.
A large dose of Procoralan could make you feel breathless or tired because your heart slows down too much.
Če ste vzeli večji odmerek zdravila Procoralan, kot bi smeli Velik odmerek zdravila Procoralan bi lahko povzročil zasoplost ali utrujenost, ker preveč upočasni srce.
Very Rare
Zelo redki:
The European Medicines Agency has waived the obligation to submit the results of studies with Procoralan in all subsets of the paediatric population in the treatment of angina pectoris.
Procoralan za vse podskupine pediatrične populacije za zdravljenje angine pektoris.
D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Tablete zdravila Procoralan 7,5 mg so lososove barve, trikotne in filmsko obložene, z zarezo na obeh straneh in vrezano oznako “7.5” na eni ter na drugi strani.
What Procoralan contains - The active substance is ivabradine (as hydrochloride).
- Zdravilna učinkovina je ivabradin (v obliki klorida).
NAME OF THE MEDICINAL PRODUCT Procoralan 5 mg film-coated tablets
IME ZDRAVILA Procoralan 5 mg filmsko obložene tablete
NAME OF THE MEDICINAL PRODUCT Procoralan 7.5 mg film-coated tablets
IME ZDRAVILA Procoralan 7,5 mg filmsko obložene tablete
- if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heart beat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
če imate kardiogeni šok (bolezen srca, ki zahteva zdravljenje v bolnišnici); če imate motnje srčnega ritma; če imate miokardni infarkt; če imate zelo nizek krvni tlak; če imate nestabilno angino pektoris (hudo obliko, pri kateri se bolečine v prsih pojavljajo zelo pogosto, med naporom ali brez njega);
Do not take Procoralan if you are pregnant or are planning to have a baby (see “Do not take Procoralan”).
Nosečnost in dojenje Ne jemljite zdravila Procoralan, če ste noseči ali če načrtujete nosečnost (glejte “Ne jemljite zdravila
The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to, <1/10); uncommon (≥1/1,000 to, <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do
Procoralan 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Procoralan 7,5 mg: ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (kar ustreza 8,085 mg ivabradinijevega klorida).
Procoralan 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Procoralan 5 mg: ena filmsko obložena tableta vsebuje 5 mg ivabradina (kar ustreza 5,390 mg ivabradinijevega klorida).
What Procoralan looks like and contents of the pack Procoralan 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other.
Tablete zdravila Procoralan 5 mg so lososove barve, podolgovate in filmsko obložene, z zarezo na obeh straneh in vrezano oznako “5” na eni ter na drugi strani.
Talk to your doctor or pharmacist before taking Procoralan - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
če opažate simptome, kot so utrujenost, vrtoglavost ali zasoplost (to bi lahko pomenilo, da se vaše srce preveč upočasnjuje); če imate simptome atrijske fibrilacije (nenavadno visok srčni utrip v mirovanju (nad 110 utripov na minuto) ali brez posebnega vzroka nereden srčni utrip, ki ga je težko izmeriti); če ste nedavno imeli možgansko kap (možganski napad); če imate blago do zmerno znižan krvni tlak;
Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Procoralan.
Če dojite ali nameravate dojiti se posvetujte z zdravnikom, ker morate z dojenjem prekiniti, če jemljete zdravilo
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Resting heart rate below 70 beats per minute prior to treatment - Cardiogenic shock - Acute myocardial infarction - Severe hypotension (< 90/50 mmHg) - Severe hepatic insufficiency - Sick sinus syndrome - Sino-atrial block - Unstable or acute heart failure - Pacemaker dependent (heart rate imposed exclusively by the pacemaker) - Unstable angina - AV-block of 3rd degree - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals
hudo jetrno popuščanje sindrom bolnega sinusnega vozla sinoatrijski blok nestabilno ali akutno srčno popuščanje odvisnost od srčnega spodbujevalnika (srčna frekvenca, ki jo narekuje izključno srčni spodbujevalnik) nestabilna angina pektoris atrioventrikularni blok 3. stopnje kombinacija z močnimi zaviralci citokroma P450 3A4, kot so azolski antimikotiki (ketokonazol, itrakonazol), makrolidni antibiotiki (klaritromicin, eritromicin peroralno, josamicin, telitromicin), zaviralci proteaze virusa HIV (nelfinavir, ritonavir) in nefazodon (glejte poglavji 4.5 in 5.2) kombinacija z verapamilom ali diltiazemom, zmernima zaviralcema citokroma P450 3A4, ki imata lastnosti zniževanja srčne frekvence (glejte poglavje 4.5)
Ivabradine is indicated : - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Ivabradin je indiciran: pri odraslih, pri katerih so antagonisti adrenergičnih receptorjev beta kontraindicirani ali jih ne prenašajo,
Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tablets ivabradine
Procoralan 7,5 mg filmsko obložene tablete ivabradin
NAME OF THE MEDICINAL PRODUCT Procoralan 5 mg film-coated tablets ivabradine
Procoralan 5 mg filmsko obložene tablete ivabradin
How to store Procoralan
Shranjevanje zdravila Procoralan
Procoralan (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Kaj je zdravilo Procoralan in za kaj ga uporabljamo Procoralan (ivabradin) je zdravilo za srce, namenjeno za zdravljenje: simptomatske stabilne angine pektoris (bolezen, ki povzroča bolečine v prsih) pri odraslih bolnikih,
The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
<1/1.000); zelo redki (<1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The study demonstrated a clinically and statistically significant relative risk reduction of 18% in the rate of the primary composite endpoint of cardiovascular mortality and hospitalisation for worsening heart failure (hazard ratio: 0.82, 95%CI [0.75;0.90] - p<0.0001) apparent within 3 months of initiation of treatment.
(razmerje tveganja: 0,82, 95 % interval zaupanja [0,75;0,90] - p<0,0001), vidnega po 3 mesecih po začetku zdravljenja.
itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris); - if you are a woman able to have children and not using reliable contraception; - if you are pregnant or trying to become pregnant; - if you are breast-feeding.
če imate srčno popuščanje, ki se je pred kratkim poslabšalo; če vam srčni utrip narekuje izključno vaš srčni spodbujevalnik; če imate hude težave z jetri; če že jemljete zdravila proti glivičnim okužbam (na primer ketokonazol, itrakonazol), makrolidne antibiotike (na primer josamicin, klaritromicin, telitromicin ali eritromicin peroralno), zdravila proti okužbam z virusom HIV (na primer nelfinavir, ritonavir) ali nefazodon (zdravilo proti depresiji) ali diltiazem, verapamil (uporabljata se za zniževanje krvnega tlaka oz. zdravljenje angine pektoris);
- in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals;
- v kliničnih elektrofizioloških študijah ivabradin ni vplival na čase atrioventrikularnega ali intraventrikularnega prevajanja ali na interval QT s popravkom; - pri bolnikih z disfunkcijo levega prekata (iztisnim deležem levega prekata med 30 in 45 %) ivabradin ni imel nobenih škodljivih učinkov na iztisni delež levega prekata.
United Kingdom Servier Laboratories Ltd Tel: +44 (0)1 753 666409
Tel: +44 (0)1 753 666409
conducted in 6505 adult patients with stable chronic CHF (for ≥ 4 weeks), NYHA class II to IV, with a reduced left ventricular ejection fraction (LVEF ≤ 35%) and a resting heart rate ≥ 70 bpm.
z zmanjšanim iztisnim deležem levega prekata (LVEF ≤ 35 %) in srčno frekvenco v mirovanju ≥ 70
The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial.
V združeni analizi vseh dvojno slepih nadzorovanih kliničnih preskušanj II.