FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic/pharmacodynamic (PK/PD) relationship PK/PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15-20 mg twice daily.
Maltese: Ir-relazzjoni farmakokinetika/farmakodinamika (PK/PD) Analiżi ta' relazzjoni PK/PD wriet li r-rata tat-taħbit tal-qalb tonqos b'mod kważi lineari meta tiżdied il-konċentrazzjoni fil-plażma, ta' ivabradine u ta' S18982 għal dożi sa 15-20 mg darbtejn kuljum.
English: Possible side effects
Maltese: Rapportar tal-effetti sekondarji
English: 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.
Maltese: Palpitazzjoni u taħbit addizzjonali tal-qalb, tħossok ma tiflaħx (nawsja), stitikezza, dijarrea, uġigħ ta' żaqq, sensazzjoni ta' tidwir (vertigo), diffikultà fit-teħid tan-nifs (dispneja), bugħawwiġ, tibdil filparametri tal-laboratorju: livelli għoljin ta' aċidu uriku fid-demm, eċċess ta' eosinofili (tip ta' ċelloli bojod tad-demm) u livell għoli ta' kreatinina fid-demm (prodott ta' tkissir tal-muskoli), raxx tal-ġilda, anġjoedema (bħal nefħa fil-wiċċ, ilsien jew griżmejn, diffikultà fit-teħid tan-nifs jew biex tibla'), pressjoni tad-demm baxxa, ħass ħażin, sensazzjoni ta' għeja, sensazzjoni ta' dgħufija, intraċċar mhux normali tal-qalb b'ECG, vista doppja, indeboliment fil-vista.
English: Children and adolescents Ivabradine JensonR is not intended for use in children and adolescents younger than 18 years.
Maltese: Tfal u Adolexxenti Ivabradine JensonR mhuwiex intenzjonat sabiex jintuża fi tfal u adoloxxenti ta' inqas minn 18-il sena.
English: The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial conducted in 6,505 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.
Maltese: L-istudju SHIFT kien studju double-blind, multiċentri, internazzjonali, randomizzat, ikkontrollat bi plaċebo, kbir tar-riżultati li sar fuq 6505 pazjent adult bi CHF kronika stabbli (għal ≥ 4 ġimgħat), NYHA tal-klassi II sa IV, fi frazzjoni mnaqqsa tat-tfigħ mill-ventrikolu tax-xellug (LVEF ≤ 35%) u rata tal-qalb waqt il-mistrieħ ta' ≥ 70 bpm.
English: The efficacy of 5 and 7.5 mg twice daily was consistent across studies on exercise test parameters (total exercise duration, time to limiting angina, time to angina onset and time to 1 mm ST segment depression) and was associated with a decrease of about 70% in the rate of angina attacks.
Maltese: L-effikaċja ta' dożi ta' 5 mg u 7.5 mg darbtejn kuljum kienet konsistenti fi studji fuq il-parametri tat-test ta' eżerċizzju fiżiku (tul totali ta' ħin ta' eżerċizzju fiżiku, ħin għal-limitazzjoni tal-anġina, ħin ta' bidu ta' anġina, ħin ta' dipressjoni ta' 1 mm fil-parti ST) u kien assoċjat ma' tnaqqis ta' madwar 70% fir-rata tal-attakki tal-anġina.
English: Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥70 bpm.
Maltese: Ivabradine huwa indikat għall-kura tas-sintomi ta' angina pectoris kronika stabbli f'adulti b'mard talarterja koronarja b'ritmu sinusali normali u rata tat-taħbit tal-qalb ≥ 70 bpm.
English: - 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 (ketoconazole,
Maltese: - Rata tat-taħbit tal-qalb mistrieħa ta' inqas minn 70 taħbita fil-minuta qabel il-kura - Xokk kardjoġeniku - Infart mijokardijaku akut - Ipotensjoni severa (< 90/50 mmHg) - Indeboliment sever tal-fwied - Sindromu sick sinus - Imblokk sino-atrijali - Insuffiċjenza tal-qalb instabbli jew akuta - Pazjenti dipendenti fuq pace maker (ir-rata tal-qalb imposta esklussivament mill-pacemaker) - Anġina instabbli - Imblokk AV tat-3 grad - Użu flimkien ma' impedituri taċ-ċitokromu qawwi P450 3A4 bħal mediċini kontra l-fungi tat-tip azole (ketoconazole, itraconazole), antibijotiċi tat-tip macrolide (clarithromycin, erythromycin per os, josamycin, telithromycin), impedituri HIV protease (nelfinavir, ritonavir) u nefazodone
English: - CYP3A4 inducers: CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St John's wort]) may decrease ivabradine exposure and activity.
Maltese: - Mediċini li jġiegħlu CYP3A4 jaħdem iżjed: Mediċini li jġiegħlu CYP3A4 jaħdem iżjed (eż. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St. John's wort] jistgħu jnaqqsu lesponiment u l-attività ta' ivabradine.
English: In the ivabradine group, 67% of patients were treated with 7.5 mg twice a day.
Maltese: Filgrupp li ngħata ivabradine, 67% tal-pazjenti ngħataw 7.5 mg darbtejn kuljum.
English: It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker.
Maltese: - jew f'kombinazzjoni ma' beta-blockers f'pazjenti li mhumiex ikkontrollati adegwatament b'doża ottimali ta' beta-blocker.
English: What Ivabradine JensonR looks like and contents of the pack Ivabradine JensonR 7.5 mg tablets are pink-coloured, round film-coated tablets marked with “I 7” on one side and “M” on the other side of the tablet.
Maltese: Kif jidher Ivabradine JensonR u l-kontenut tal-pakkett Ivabradine JensonR 7.5 mg pilloli huma pilloli miksija b'rita kulur roża, tondi, imnaqqxa b'“I 7” fuq naħa waħda u “M” fuq in-naħa l-oħra.
English: Erythema Pruritus Urticaria
Maltese: Popolazzjoni pedjatrika
English: Potassium-depleting diuretics (thiazide diuretics and loop diuretics): hypokalaemia can increase the risk of arrhythmia.
Maltese: Dijuretiċi li jnaqqsu l-potassju (dijuretiċi thiazidic u dijuretiċi loop): ipokalemija tista' żżid ir-riskju ta' arrittmija.
English: Bradycardia was reported by 17.9% of patients in the ivabradine group (2.1% in the placebo group).
Maltese: Ġiet irrapportata bradikardija minn 17.9% tal-pazjenti fil-grupp ta' ivabradine (2.1% fil-grupp tal-plaċebo). 7.1% tal-pazjenti ngħataw verapamil, diltiazem jew inibituri qawwija ta' CYP 3A4 waqt l-istudju.
English: PVC/Aclar-Alu perforated unit dose pack in pack sizes of 14 x 1 and 56 x 1 film-coated tablets.
Maltese: Folji ta' doża waħda (PVC/Aclar-Alu) f'daqsijiet tal-pakkett ta' 14 x 1 u 56 x 1 pillola miksija b'rita.
English: Syncope, possibly related to bradycardia
Maltese: Sinkope, possibbilment relatata ma' bradikardija
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallmediċini http://www.ema.europa.eu/
English: How to store Ivabradine JensonR
Maltese: Mediċini oħra u Ivabradine JensonR
English: INFORMATION IN BRAILLE Ivabradine JensonR 5 mg film-coated tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Ivabradine JensonR 5 mg pilloli miksija b'rita
English: The pack sizes 14 x 1 and 56 x 1 film-coated tablets are presented in unit dose blisters.
Maltese: Id-daqsijiet tal-pakkett 14 x 1 u 56 x 1 pillola miksija b'rita huma ppreżentati f'folji ta' doża waħda.
English: INFORMATION IN BRAILLE Ivabradine JensonR 7.5 mg film-coated tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Ivabradine JensonR 7.5 mg pilloli miksija b'rita
English: Pink colour, round, beveled edge, biconvex film-coated tablets, approximately 6.65 mm in diameter debossed with “Ι 7” on one side and “M” on other side of the tablet.
Maltese: Pilloli miksija b'rita kulur roża, tondi, b'tarf imżerżaq, imbuzzati, b'dijametru ta' madwar 6.65 mm, imnaqqxa b'“I 7” fuq naħa waħda u “M” fuq in-naħa l-oħra.
English: Very common
Maltese: Rari*
English: - Paediatric population: The pharmacokinetic profile of ivabradine in paediatric chronic heart failure patients aged 6 months to less than 18 years is similar to the pharmacokinetics described in adults when a titration scheme based on age and weight is applied.
Maltese: Il-profil farmakokinetiku ta' ivabradine f'pazjenti b'insuffiċjenza kardijaka kronika fit-tfal li għandhom bejn 6 xhur u inqas minn 18-il sena huwa simili għallfarmakokinetika deskritta fl-adulti meta tiġi applikata skema ta' titrazzjoni bbażata fuq l-età u lpiż.
English: The study showed no difference in the rate of the primary composite outcome in the ivabradine group by comparison to the placebo group (relative risk ivabradine: placebo 1.00, p = 0.945).
Maltese: L-istudju ma wera ebda differenza fir-rata tar-riżultat kompost primarju filgrupp tal-ivabradine meta mqabbel mal-grupp tal-plaċebo (riskju relattiv ivabradine:plaċebo 1.00, p=0.945).
English: (5 mg b.i.d, if age ≥75 years) and titration up to 10 mg b.i.d).
Maltese: Intużat skema terapewtika ogħla mill-pożoloġija approvata (doża tal-bidu ta' 7.5 mg b.i.d (5 mg b.i.d, jekk l-età kienet ≥ 75 sena) u titrazzjoni sa 10 mg b.i.d).
English: 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.
Maltese: Impedituri ta' CYP3A4 moderati: studji speċifiċi ta' interazzjoni fuq voluntiera b'saħħithom u f'pazjenti wrew li l-użu flimkien ta' ivabradine mal-mediċini li jnaqqsu r-rata tat-taħbit tal-qalb diltiazem jew verapamil irriżulta f'żieda fl-esponiment għal ivabradine (żieda minn 2 sa 3 darbiet flAUC) u nuqqas addizzjonali fir-ritmu tat-taħbit tal-qalb ta' 5 bpm.
English: - Hepatic impairment: in patients with mild hepatic impairment (Child Pugh score up to 7) unbound AUC of ivabradine and the main active metabolite were about 20% higher than in subjects with normal hepatic function.
Maltese: - Indeboliment tal-fwied: f'pazjenti b'indeboliment ħafif tal-fwied (Child Pugh sa 7 punti) l-AUC ta' ivabradine maħlul u l-prodott attiv tal-metaboliżmu prinċipali kienu madwar 20% ogħla milli f'pazjenti fejn il-fwied kien jaħdem normali.
English: The metabolism of this active metabolite also involves CYP3A4.
Maltese: Ilmetaboliżmu ta' din is-sustanza attiva ffurmata fil-metaboliżmu wkoll tinvolvi CYP3A4.
English: Uncontrolled blood pressure Hypotension, possibly related to bradycardia
Maltese: Pressjoni tad-demm mhux ikkontrollata Pressjoni baxxa, possibbilment relatata ma' bradikardija
English: In a post-hoc subgroup of patients with symptomatic angina at randomisation (n = 1,507), no safety signal was identified regarding cardiovascular death, hospitalisation for acute MI or heart failure (ivabradine 12.0% versus placebo 15.5%, p = 0.05).
Maltese: F'subgrupp post-hoc ta' pazjenti b'anġina sintomatika f'randomizzazzjoni (n=1507), ma ġie identifikat ebda sinjal ta' sigurtà fir-rigward ta' mewta kardjovaskulari, rikoveru l-isptar għal MI akuta jew insuffiċjenza tal-qalb (ivabradine 12.0% kontra plaċebo 15.
English: The antianginal and anti-ischaemic efficacy of ivabradine was preserved in diabetic patients (n = 457) with a similar safety profile as compared to the overall population.
Maltese: L-effikaċja ta' ivabradine kontra l-anġina u kontra l-iskemija nżammet f'pazjenti dijabetiċi (n = 457) bl-istess profil ta' sigurtà meta mqabbla mal-popolazzjoni inġenerali.
English: If you are being treated for stable angina pectoris
Maltese: Kura sintomatika ta' anġina pectoris kronika stabbli
English: Ivabradine JensonR 5 mg film-coated tablets Each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Maltese: Ivabradine JensonR 5 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 5 mg ivabradine (bħala hydrochloride) Eċċipjent b'effett magħruf.
English: Applicable only for the outer packaging component: PC:
Maltese: Applikabbli biss għall-komponent tal-ippakkjar ta' barra: PC:
English: Ivabradine JensonR with food and drink Avoid grapefruit juice during treatment with Ivabradine JensonR.
Maltese: Ivabradine JensonR ma' ikel u xorb Evita li tieħu il-meraq tal-grejpfrut meta tkun qed tieħu Ivabradine JensonR.
English: What Ivabradine JensonR looks like and contents of the pack Ivabradine JensonR 5 mg tablets are pink-coloured, oval shaped film-coated tablets scored on both sides, marked with “ I 5” on one side and “M” on the other side of the tablet.
Maltese: Kif jidher Ivabradine JensonR u l-kontenut tal-pakkett Ivabradine JensonR 5 mg pilloli huma kulur roża, ovali, b'sinjal imnaqqax fuq żewġ naħat, imnaqqxa b'“I 5” fuq naħa waħda u “M” fuq in-naħa l-oħra.
English: Ivabradine JensonR is also available in bottles with a screw cap and a desiccant of 56, 98 and 100 film-coated tablets.
Maltese: Ivabradine JensonR huwa disponibbli wkoll fi fliexken b'tapp bil-kamin u dessikant ta' 56, 98 u 100 pillola miksija b'rita.
English: Ivabradine JensonR 5 mg film-coated tablets ivabradine
Maltese: Ivabradine JensonR 5 mg pilloli miksija b'rita ivabradine
English: Ivabradine JensonR 7.5 mg film-coated tablets ivabradine
Maltese: Ivabradine JensonR 7.5 mg pilloli miksija b'rita ivabradine
English: The PK/PD relationship of ivabradine in paediatric chronic heart failure patients aged 6 months to less than 18 years is similar to the PK/PD relationship described in adults.
Maltese: Ir-relazzjoni PK/PD ta' ivabradine f'pazjenti b'insuffiċjenza kardijaka kronika pedjatrika li għandhom bejn 6 xhur u inqas minn 18-il sena hija simili għar-relazzjoni PK/PD deskritta fl-adulti.
English: Malaise, possibly related to bradycardia
Maltese: Astenja, possibbilment relatata ma' bradikardija
English: In addition there was no clinically significant effect of ivabradine on the pharmacokinetics of simvastatin, amlodipine, lacidipine, on the pharmacokinetics and pharmacodynamics of digoxin, warfarin and on the pharmacodynamics of aspirin.
Maltese: Barra minn hekk, ma kienx kemm effett klinikament sinifikanti ta' ivabradine fuq il-farmakokinetika ta' simvastatin, amlodipine, lacidipine fuq il- farmakokinetika u lfarmakodinamika ta' digoxin, warfarin u fuq il-farmakodinamika ta' aspirin.
English: ibutilide, amiodarone).
Maltese: - quinidine, disopyramide, ibutilide, sotalol, amiodarone (għall-kura ta' problemi fir-ritmu
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Ivabradine JensonR 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Maltese: F'xi każijiet (eż. jekk inti anzjan), it-tabib tiegħek jista' jordnalek nofs id- doża, jiġifieri nofs pillola ta' 5 mg ta' Ivabradine JensonR 5 mg (li tikkorrispondi għal 2.5 mg ta' ivabradine) filgħodu u nofs pillola ta' 5 mg filgħaxija.
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).
Maltese: Ivabradine m'huwiex effikaċi fil-kura jew prevenzjoni ta' arritmiji kardijaċi u bl-istess mod jitlef leffikaċja tiegħu meta sseħħ taki-arritmija (eż. takikardija ventrikulari jew supraventrikulari).
English: N-desmethylated derivative of ivabradine has been identified as the main active metabolite in humans.
Maltese: Id-derivattiv N-desmethylated ta' ivabradine ġie identifikat bħala s-sustanza attiva maġġura ffurmata filmetaboliżmu fil-bniedem.
English: In particular, the additional benefit over 5 mg twice daily was established in a reference-controlled study versus atenolol: total exercise duration at trough was increased by about 1 minute after one month of treatment with 5 mg twice daily and further improved by almost 25 seconds after an additional 3-month period with forced titration to 7.5 mg twice daily.
Maltese: Benefiċċju ieħor ta' aktar minn 5 mg darbtejn kuljum ġie stabbilit fi studju reference-controlled versus atenolol: it-tul ta' ħin ta' eżerċizzju żdied bi kważi minuta wara xahar ta' kura b'doża ta' 5 mg darbtejn kuljum u reġa' żdied bi kważi 25 sekonda wara 3 xhur oħra ta' kura b'doża mgħaġġla ta' 7.5 mg darbtejn kuljum.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farma farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Very rare (may affect up to 1 in 10,000 people): Irregular heart beats.
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000):
English: Cold form blisters (OPA/Alu/PVC) in pack sizes of 14, 28, 56, 98 and 112 film-coated tablets.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folji maħduma bierda (OPA/Alu/PVC) f'daqsijiet tal-pakkett ta' 14, 28, 56, 98 u 112-il pillola miksija b'rita.
English: Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate.
Maltese: Ivabradine hu prodott mediċinali li jnaqqas ir-rata tat-taħbit tal-qalb b'mod pur billi jimpedixxi b'mod selettiv u speċifiku l-pace maker b'kurrent If kardijaku li jikkontrolla d-depolorazzjoni dijastolika spontanja fis-sinus node u jirregola r-rata tat-taħbit tal-qalb.
English: Talk to your doctor or pharmacist before taking Ivabradine JensonR - 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
Maltese: palpitazzjonijiet, żieda fl-uġigħ fis-sider) jew fibrillazzjoni atrijali sostnuta (tip ta' taħbita tal qalb irregolari), jew anormalità ta' elettrokardjogramma (ECG) imsejħa 'sindromu QT imtawwal', - jekk għandek sintomi ta' għejja, sturdament jew qtugħ ta' nifs (dan jista' jfisser li għandek il
English: Ivabradine JensonR 7.5 mg film-coated tablets
Maltese: Ivabradine JensonR 7.5 mg pilloli miksija b'rita.
English: Each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 5 mg ivabradine (bħala hydrochloride).
English: EU/1/16/1145/001 EU/1/16/1145/002 EU/1/16/1145/003 EU/1/16/1145/004 EU/1/16/1145/005 EU/1/16/1145/006 EU/1/16/1145/007 EU/1/16/1145/008 EU/1/16/1145/009 EU/1/16/1145/010 EU/1/16/1145/011 EU/1/16/1145/012 EU/1/16/1145/013 EU/1/16/1145/014 EU/1/16/1145/015
Maltese: EU/1/16/1145/006 EU/1/16/1145/007 EU/1/16/1145/008 EU/1/16/1145/009 EU/1/16/1145/010
English: Ivabradine JensonR 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 7.5 mg ivabradine (bħala hydrochloride).
English: Ivabradine JensonR contains lactose
Maltese: Ivabradine JensonR fih il-lactose
English: Paediatric population
Maltese: - Popolazzjoni pedjatrika:
English: Ivabradine JensonR 5 mg film-coated tablets
Maltese: Ivabradine JensonR 5 mg pilloli miksija b'rita.
English: Tel: +385 1 23 50 599
Maltese: Mylan EPD d.o.o. Tel: +385 1 23 50 599
English: Ivabradine JensonR mainly works by reducing the heart rate by a few beats per minute.
Maltese: Ivabradine JensonR jaħdem billi jnaqqas ir-rata tat-taħbit tal-qalb bi ftit taħbit fil-minuta.
English: 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.
Maltese: Minħabba li l-pilloli fihom il-lactose, pazjenti bi problemi ereditarji rari ta' intolleranza ta' galactose, defiċenzja ta' lactose tat-tip Lapp jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Do not take Ivabradine JensonR if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Ivabradine JensonR”).
Maltese: Tiħux Ivabradine JensonR jekk tista' tinqabad tqila ħlief jekk qed tuża miżuri ta' kontraċezzjoni affidabbli (ara “Tiħux Ivabradine JensonR”).
English: Luminous phenomena (phosphenes) are described as a transient enhanced brightness in a limited area of the visual field (see section 4.8).
Maltese: Fenomeni mudwali (ċrieki tad-dawl) huma meqjusin bħala luminożità qawwija ta' dawl temporanju f'parti limitata talqasam viżiv (ara sezzjoni 4.8).
English: Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Ivabradine JensonR or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions: - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Maltese: Kun ċert li tgħarraf lit-tabib tiegħek jekk qed tieħu xi mediċini hawn taħt imsemmija, għax ikun hemm bżonn ta' aġġustar tad-doża ta' Ivabradine JensonR jew li titqiegħed taħt osservazzjoni: - fluconazole (mediċina antifungali) - rifampicin (antibijotiku) - barbiturates (għal min ibati biex jorqod jew għall-epilepsija) - phenytoin (għall-epilepsija) - Hypericum perforatum jew St.
English: Cessation of treatment should be considered if any unexpected deterioration in visual function occurs.
Maltese: Wieħed għandu jikkunsidra jekk titwaqqafx il-kura kemm-il darba jkun hemm deterjorament mhux mistenni fil-funzjoni visuali.
English: The intake of St John's wort should be restricted during the treatment with ivabradine.
Maltese: John's wort waqt il-kura b'ivabradine.