FrancophonIA/ELRC3.0 huggingface dataset:
English: Numeta G13%E, which is given into a vein to premature babies to provide nutritional support (intravenous nutrition or parenteral nutrition), will remain suspended until a re-formulated preparation is made available.
Slovenian: Zdravilo Numeta G13%E, ki se daje v veno pri nedonošenčkih kot prehranska podpora (intravenska prehrana oziroma parenteralna prehrana), bo začasno umaknjeno s trga, dokler ne bo na voljo pripravek z novo formulacijo.
English: Doctors will monitor newborns and children who are receiving Numeta G16%E for symptoms of hypermagnesaemia such as weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Slovenian: Zdravniki bodo spremljali novorojenčke in otroke, ki dobivajo pripravek Numeta G16%E, glede simptomov hipermagneziemije, kot so oslabelost, navzeja in bruhanje, težave z dihanjem, hipotenzija (nizek krvni tlak) in aritmije (nepravilno bitje srca).
English: Hypermagnesaemia is a serious condition and symptoms may include weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Slovenian: Hipermagneziemija je resna bolezen, katere simptomi so oslabelost, slabost in bruhanje, težave z dihanjem, hipotenzija (nizek krvni tlak) in aritmije (nepravilno bitje srca).
English: While Numeta G13%E is suspended, healthcare professionals should use alternative nutrition solutions which may include authorised standardised or individually prepared solutions.
Slovenian: V času, ko bo pripravek Numeta G13%E začasno umaknjen, naj zdravstveni delavci uporabljajo druge hranilne raztopine, ki so bodisi odobrene standardizirane ali individualno pripravljene raztopine.
English: Parenteral nutrition is the providing of nutrients and fluids through a vein in patients who cannot be fed by mouth or by enteral nutrition (the use of a feeding tube passed directly into the gut).
Slovenian: Parenteralno hranjenje pomeni, da bolniki, ki jih ni mogoče hraniti skozi usta ali z enteralno prehrano (uporabo sonde za hranjenje, ki se uvede neposredno v črevo), dobivajo hranilne snovi in tekočine skozi veno.
English: • When giving Numeta G16%E, doctors should monitor serum magnesium levels, along with other electrolyte levels at baseline and at appropriate intervals thereafter.
Slovenian: • Pri dajanju zdravila Numeta G16%E morajo zdravniki preveriti koncentracije magnezija in drugih elektrolitov v serumu ob izhodišču in nato še v rednih razmikih po tem.
English: • Because of the risk of hypermagnesaemia (high blood levels of magnesium), the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
Slovenian: • Zaradi tveganja za hipermagneziemijo (visoke koncentracije magnezija v krvi) je bil prehranski pripravek Numeta G13%E začasno umaknjen s trga, dokler ne bo na voljo v obliki z novo formulacijo.
English: • Following several reports of hypermagnesaemia in preterm infants, the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
Slovenian: • Potem ko so poročali o več primerih hipermagneziemije pri nedonošenčkih, je bil prehranski pripravek Numeta G13%E začasno umaknjen s trga, dokler ne bo na voljo v obliki z novo formulacijo.
English: Numeta G13%E is given into a vein to provide nutritional support in premature babies who cannot be fed by mouth or with a feeding tube.
Slovenian: Pripravek Numeta G13%E se daje v veno za prehransko podporo pri nedonošenčkih, ki jih ni mogoče hraniti skozi usta ali po sondi za hranjenje.
English: Canada T, Crill C, Guenter P. A.S.P.E.N.
Slovenian: Canada, T., Crill, C., Guenter, P., A.S.P.E.N., Priročnik za parenteralno hranjenje, Ameriško združenje za parenteralno in enteralno prehrano, Silver Spring, Maryland, 2009, str. 167.
English: The doctor will stop giving Numeta G16%E if magnesium levels are high, or will give Numeta at a slower rate.
Slovenian: V primeru visokih koncentracij magnezija bo zdravnik prekinil ali upočasnil dajanje pripravka Numeta G16%E.
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, predlagataljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Poland
Slovenian: Poljsko
English: Hungary
Slovenian: Madžarski
English: Lithuania
Slovenian: Litvo
English: Finland
Slovenian: Finski
English: Sweden
Slovenian: Danski
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: 2700 AN, Zoetermeer The Netherlands
Slovenian: 2700 AN, Zoetermeer Nizozemska
English: Via E. Folli 50 20134 Milano Italy
Slovenian: Via E. Folli 50 20134 Milano Italija
English: Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italy
Slovenian: Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italija
English: Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italy
Slovenian: Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italija
English: Laboratorio Tau, S.A. C/ Serrano Galvache, 56 Edificio Roble 28033 Madrid Spain
Slovenian: Laboratorio Tau, S.A. C/ Serrano Galvache, 56 Edificio Roble 28033 Madrid Španija
English: Netherlands AstraZeneca BV Postbus 599
Slovenian: Nizozemska AstraZeneca BV Postbus 599
English: Hungary AstraZeneca Kft. H-2045 Törökbálint, Park u. 3.
Slovenian: Madžarska AstraZeneca Kft. H-2045 Törökbálint, Park u.
English: Norway AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO
Slovenian: Norveška AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO
English: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finland
Slovenian: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finska
English: AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom
Slovenian: AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU Velika Britanija
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece
Slovenian: 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Grčija
English: AstraZeneca UK Ltd., Silk Road Business Park ,SK10 2NA Macclesfield, Cheshire, United Kingdom
Slovenian: AstraZeneca UK Ltd., Silk Road Business Park ,SK10 2NA Macclesfield, Cheshire, Velika Britanija
English: DK-2620 Albertslund Denmark
Slovenian: DK-2620 Albertslund Danska
English: 1, Place Renault 92844 RUEIL-MALMAISON Cedex
Slovenian: AstraZeneca 1, Place Renault 92844 RUEILMALMAISON Cedex Francija
English: AstraZeneca A/S Roskildevej 22 2620 Albertslund Denmark
Slovenian: AstraZeneca A/S Roskildevej 22 2620 Albertslund Danska
English: Germany AstraZeneca GmbH 22876 Wedel
Slovenian: AstraZeneca GmbH 22876 Wedel Nemčija
English: AstraZeneca AB, 151 85 Södertälje Sweden
Slovenian: AstraZeneca AB, 151 85 Södertälje, Švedska
English: Sweden AstraZeneca AB S-151 85 Södertälje Sweden
Slovenian: Romunija AstraZeneca AB, S-151 85 Södertälje Švedska
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien
Slovenian: Schwarzenbergplatz 7, A-1037 Wien Avstrija
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels
Slovenian: Luksemburg NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels
English: , Ενέσιμο λυόφιλο για ενδοφλέβια έγχυση 40 mg/VIAL
Slovenian: Losec, Ενέσιμο λυόφιλο για ενδοφλέβια έγχυση 40
English: MUPS
Slovenian: Ciper
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels
Slovenian: NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussel
Slovenian: NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussel
English: 10 mg Film-coated gastroresistant tablets
Slovenian: 10 mg Filmsko obložene gastrorezistentne tablete
English: Γαστροανθεκτικό καψάκιο σκληρό 20 mg/CAP
Slovenian: Γαστροανθεκτικό δισκίο 20
English: Γαστροανθεκτικό καψάκιο σκληρό 40 mg/CAP
Slovenian: Γαστροανθεκτικό δισκίο 40
English: Γαστροανθεκτικό καψάκιο σκληρό 10 mg/CAP
Slovenian: Γαστροανθεκτικό δισκίο 10
English: 10 mg Capsules
Slovenian: 10 mg Kapsule
English: 20 mg Capsules
Slovenian: 20 mg Kapsule
English: , Ενέσιμο λυόφιλο 40 mg/VIAL
Slovenian: mg/VIAL
English: Gastro-resistant, film-coated tablet
Slovenian: Gastrorezistentne filmsko obložene tablete
English: 40 mg Powder for infusion
Slovenian: 40 mg Prašek za infuzijo
English: Losec-Mups 40mg 40 mg Gastroresistant tablets
Slovenian: Losec MUPS 40 40 mg Gastrorazistentne tablete Peroralna uporaba NA
English: Losec 10 mg kapszula 10 mg Capsule, hard
Slovenian: Losec 10 mg kapszula
English: 20 m Gastro-resistant tablets
Slovenian: 20 m Gastrorezistentne tablete Peroralna uporaba NA
English: Losec-Mups 10mg 10 mg Gastroresistant tablets
Slovenian: Losec MUPS 10 10 mg Gastrorazistentne tablete Peroralna uporaba NA
English: Losec 40 mgTrockenstechampulle mit Lösungsmittel
Slovenian: Losec 40 mgTrockenstechamp ulle mit
English: 40 mg Gastroresistant capsules
Slovenian: 40 mg Trde gastrorezistentne kapsule
English: ANNEX I
Slovenian: Intravenska uporaba NA
English: Losec Capsules 10mg 10mg Hard gelatin capsules
Slovenian: Losec Capsules 10mg
English: Losec-Mups 20mg 20 mg Gastroresistant tablets
Slovenian: Losec MUPS 20 20 mg Gastrorazistentne tablete Peroralna uporaba NA
English: 10 mg Gstroresistant capsules
Slovenian: 10 mg Trde kapsule
English: 20 mg Gastroresistant capsules
Slovenian: 20 mg Trde gastrorezistentne kapsule
English: 10 mg Hard Gastroresistant capsules Oral use
Slovenian: 10 mg Gastrorezistentne kapsule Peroralna uporaba NA
English: LOSEC 20 mg
Slovenian: LOSEC cápsulas 20 mg
English: 20 mg Hard Gastroresistant capsules Oral use
Slovenian: 20 mg Gastrorezistentne kapsule Peroralna uporaba NA
English: LOSEC 40 mg
Slovenian: Losec Infusion 40mg
English: 40 mg Hard Gastroresistant capsules Oral use
Slovenian: 40 mg Gastrorezistentne kapsule Peroralna uporaba NA
English: Losec Capsules 20mg 20mg Hard gelatin capsules
Slovenian: LOSEC 20 mg 20 mg Trde gastrorezistentne kapsule
English: Losec 20 mg kapszulaz 20 mg Capsule, hard
Slovenian: Losec 20 mg kapszulaz
English: 20mg
Slovenian: Antra MUPS 20 mg
English: Losec MUPS 10
Slovenian: Losec 10mgKapseln
English: 40 mg Gastroresistant tablets
Slovenian: 40 mg Liofilizat za perfuzijo
English: Losec 40 MG
Slovenian: Losec Capsules 40mg
English: Losec MUPS 20
Slovenian: Losec 20mgKapseln
English: Antra MUPS 10 mg 10 mg Gastro-resistant tablets
Slovenian: Antra MUPS 10 mg
English: 40 mg Powder for solution for intravenous infusion
Slovenian: 40 mg Prašek za raztopino za intravensko infuzijo
English: 40 mg/ml Powder and Solvens for solution for injection
Slovenian: 40 mg/ml Prašek in topilo za raztopino za injiciranje
English: 40 mg Powder and solvent for injectable solution
Slovenian: 40 mg Prašek in topilo za raztopino za injiciranje
English: The absolute risk reduction was 4.2%.
Slovenian: Absolutno zmanjšanje tveganja je bilo 4,2%.
English: Do not take a double dose to make up for the forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
English: Available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče podati.
English: United Kingdom EX31 3UD
Slovenian: Velika Britanija EX31 UD
English: About 4% of an oral dose is excreted unchanged in urine.
Slovenian: Približno 4% peroralnega odmerka se izloča nespremenjenega z urinom.
English: Food delayed absorption by approximately 1 hour, and increased plasma exposure by 20 to 30%.
Slovenian: Hrana je upočasnila absorpcijo za približno 1 uro in povečala izpostavljenost v plazmi za 20 do 30%.
English: 2900 Komárom Hungary
Slovenian: 2900 Komárom Madžarska
English: Therefore the intake of grapefruit juice should be avoided.
Slovenian: Pitju grenivkinega soka se je torej treba izogibati.
English: The absolute bioavailability of the film-coated tablets is around 40%, due to first-pass effect in the gut and liver.
Slovenian: Absolutna biološka uporabnost filmsko obloženih tablet znaša okoli 40% zaradi učinka prvega prehoda skozi črevesje in jetra.
English: All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment.
Slovenian: Vsi fosfeni so ponehali med zdravljenjem ali po njem, in sicer večina med zdravljenjem (77,5%).
English: Applicable only for the outer packaging component: PC:
Slovenian: Samo za zunanjo ovojnino: PC:
English: Bradycardia was reported by 3.3% of patients particularly within the first 2 to 3 months of treatment initiation.
Slovenian: O bradikardiji so poročali pri 3,3% bolnikov, zlasti v prvih 2 do 3 mesecih po uvedbi zdravljenja.
English: Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes.
Slovenian: Manj kot 1% bolnikov je zaradi fosfenov spremenilo svojo vsakdanjo rutino ali prekinilo zdravljenje.
English: The effects on blood pressure and peripheral vascular resistance were minor and not clinically significant.
Slovenian: Učinek na krvni tlak in periferni žilni upor je bil majhen in klinično neznačilen.
English: Hazard ratio [95% CI]
Slovenian: razmerje tveganja [95% interval zaupanja]
English: Do not use this medicine after the expiry date which is stated on the carton, bottle and blister after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, plastenki in pretisnem omotu poleg oznake "EXP:".
English: Children and adolescents Ivabradine JensonR is not intended for use in children and adolescents younger than 18 years.
Slovenian: Otroci in mladostniki Zdravilo Ivabradin JensonR ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: They particularly occur within the first 2 to 3 months of treatment initiation.
Slovenian: Pojavljajo se predvsem v prvih 2 do 3 mesecih zdravljenja.
English: Temporary cardiac electrical pacing may be instituted if required.
Slovenian: Če je potrebno, se lahko uvede začasno električno spodbujanje srca.
English: The long-term effects of ivabradine on growth, puberty and general development as well as the long-term efficacy of therapy with ivabradine in childhood to reduce cardiovascular morbidity and mortality have not been studied.
Slovenian: Dolgoročni učinki ivabradina na rast, puberteto in splošen razvoj, kakor tudi dolgoročna učinkovitost terapije z ivabradinom za zmanjševanje srčno-žilne umrljivosti in umrljivosti v otroški dobi niso bili preučevani.
English: Modification in the heart functioning (the symptoms are a slowing down of the heart rate).
Slovenian: Spremembe načina delovanja srca (simptom je znižana srčna frekvenca).
English: 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).
Slovenian: V kliničnih študijah so poročali o naslednjih neželenih učinkih, ki so razvrščeni po naslednji pogostnosti: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur.
Slovenian: Bolnike je potrebno obvestiti o znakih in simptomih atrijske fibrilacije in jim svetovati, da v primeru njihovega pojava za pomoč prosijo svojega zdravnika.
English: Other medicines and Ivabradine JensonR Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Ivabradin JensonR Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: If you think that the effect of Ivabradine JensonR is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Ivabradin JensonR premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ivabradine in children aged 0 to less than 6 months in the treatment of chronic heart failure.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z ivabradinom za otroke, stare od 0 do manj kot 6 mesecev starosti za zdravljenje kroničnega srčnega popuščanja.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Jenson R+ Limited
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Jenson R+ Limited
English: The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night.
Slovenian: Možen nastanek tovrstnih pojavov svetlikanja je potrebno upoštevati pri vožnji ali upravljanju s stroji v pogojih, kjer se lahko nenadno spreminja jakost svetlobe, zlasti med vožnjo ponoči.
English: Jenson R+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, United Kingdom EX31 3UD
Slovenian: Jenson R+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, Velika Britanija EX31 3UD
English: In this way Ivabradine JensonR helps to control and reduce the number of angina attacks.
Slovenian: Na ta način zdravilo Ivabradin JensonR pripomore k nadzoru in zmanjševanju anginoznih napadov.
English: Luminous phenomena (phosphenes) were reported by 14.5% of patients, described as a transient enhanced brightness in a limited area of the visual field.
Slovenian: O pojavih svetlikanja (fosfenih) so poročali pri 14,5% bolnikov, opisujejo pa jih kot prehodno povečanje svetlosti na omejenem področju vidnega polja.
English: If atrial fibrillation develops during treatment, the balance of benefits and risks of continued ivabradine treatment should be carefully reconsidered.
Slovenian: Če se atrijska fibrilacija razvije med zdravljenjem, je potrebno pazljivo pretehtati ravnovesje med koristmi in tveganji nadaljnjega zdravljenja z ivabradinom.
English: The use of ivabradine is not recommended immediately after a stroke since no data is available in these situations.
Slovenian: Jemanje ivabradina takoj po možganski kapi ni priporočljivo, saj ni na voljo podatkov o tovrstnih stanjih.
English: There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine.
Slovenian: Ni dokazov o morebitnem tveganju za pojav (prevelike) bradikardije ob vrnitvi na sinusni ritem pri sprožanju farmakološke kardioverzije pri bolnikih, ki jemljejo ivabradin.
English: If the combination appears necessary, close cardiac monitoring is needed.
Slovenian: Če je kljub vsemu kombinacija potrebna, je treba skrbno spremljati delovanje srca.
English: Severe bradycardia should be treated symptomatically in a specialised environment.
Slovenian: Bolnike s hudo bradikardijo je potrebno zdraviti simptomatsko v specializiranem okolju.
English: Ivabradine is eliminated with a main half-life of 2 hours (70-75% of the AUC) in plasma and an effective half-life of 11 hours.
Slovenian: Ivabradin se izloča z glavno razpolovno dobo 2 uri (70 do 75% površine pod krivuljo (AUC)) v plazmi in efektivno razpolovno dobo 11 ur.
English: The safety and efficacy of ivabradine in the treatment of chronic heart failure in children aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost ivabradina pri zdravljenju kroničnega srčnega popuščanja pri otrocih, mlajših od 18 let, nista bili dokazani.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing ivabradine in all subsets of the paediatric population in the treatment of angina pectoris (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z ivabradinom za vse podskupine pediatrične populacije za zdravljenje angine pektoris (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine JensonR.
Slovenian: Koledar, ki je natisnjen na pretisnem omotu s tabletami, vam pomaga, da si zapomnite, kdaj ste nazadnje vzeli tableto zdravila Ivabradin JensonR.
English: N-desmethylated derivative of ivabradine has been identified as the main active metabolite in humans.
Slovenian: N-demetilirani derivat ivabradina so določili kot poglavitni aktivni presnovek pri ljudeh.
English: The results on the primary endpoint are mainly driven by the heart failure endpoints, hospitalisation for worsening heart failure (absolute risk reduced by 4.7%) and deaths from heart failure (absolute risk reduced by 1.1%).
Slovenian: Rezultat končnega izida je izmerjen predvsem na podlagi izidov srčnega popuščanja, hospitalizacij zaradi poslabšanj srčnega popuščanja (absolutno zmanjšanje tveganja za 4,7%) in umrljivosti zaradi srčnega popuščanja (absolutno zmanjšanje tveganja za 1,1%).
English: EXP Bottle: After first opening, use within 6 months.
Slovenian: EXP: Plastenka: Po odprtju porabite v roku 6 mesecev.
English: Uncontrolled blood pressure Hypotension, possibly related to bradycardia
Slovenian: Žilne bolezni nenadzorovan krvni tlak hipotenzija, možno zaradi bradikardije
English: If you are pregnant and have taken Ivabradine JensonR, talk to your doctor.
Slovenian: Če ste noseči in ste jemali zdravilo Ivabradin JensonR, se posvetujte z zdravnikom.
English: Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when a tachyarrhythmia occurs (e.g. ventricular or supraventricular tachycardia).
Slovenian: Uporaba ivabradina ni učinkovita pri zdravljenju ali preprečevanju srčnih aritmij in verjetno izgubi učinkovitost ob pojavu tahiartimij (na primer ventrikularne ali supraventrikularne tahikardije).
English: Patients received standard care including beta-blockers (89%), ACE inhibitors and/or angiotensin II antagonists (91%), diuretics (83%), and anti-aldosterone agents (60%).
Slovenian: Bolniki so prejemali standardno zdravljenje, ki je vključevalo antagoniste adrenergičnih receptorjev beta (89%), zaviralce ACE in/ali antagoniste angiotenzina II (91%), diuretike (83%) in antagoniste aldosterona (60%).
English: Use in patients with AV-block of 2nd degree Ivabradine is not recommended in patients with AV-block of 2nd degree.
Slovenian: Uporaba pri bolnikih z atrioventrikularnim blokom 2. stopnje Uporaba ivabradina ni priporočljiva pri bolnikih z atrioventrikularnim blokom 2. stopnje.
English: The major active metabolite is the N-desmethylated derivative (S 18982) with an exposure about 40% of that of the parent compound.
Slovenian: Poglavitni aktivni presnovek je N-demetilirani derivat (S 18982) z izpostavljenostjo, ki znaša približno 40% tiste pri matični učinkovini.
English: 14 film-coated tablets 14 x 1 film-coated tablets 28 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 98 film-coated tablets 112 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 14 x 1 filmsko obložena tableta 28 filmsko obloženih tablet 56 filmsko obloženih tablet 56 x 1 filmsko obložena tableta 98 filmsko obloženih tablet 112 filmsko obloženih tablet
English: The most common adverse reactions with ivabradine, luminous phenomena (phosphenes) and bradycardia, are dose dependent and related to the pharmacological effect of the medicinal product.
Slovenian: Najpogostnejši neželeni učinki ob ivabradinu, pojavi svetlikanja (fosfeni) in bradikardija, so bili odvisni od odmerka in povezani s farmakološkim delovanjem zdravila.