FrancophonIA/ELRC3.0 huggingface dataset:
English: The starting dose was 0.02 mg/kg bid in age-subset [6-12[months, 0.05 mg/kg bid in [1-3[ years and
Maltese: Id-doża tal-bidu kienet 0.02 mg/kg darbtejn kuljum fis-sottogrupp bejn [6-12[-il xahar, 0.05 mg/kg darbtejn kuljum f'età bejn [1-3[ snin u f'età bejn [3-18[-il sena <40 kg, u 2.5 mg darbtejn kuljum f'età bejn [3-18[-il sena u ≥40 kg.
English: Talk to your doctor or pharmacist before taking Ivabradine Anpharm - 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: - jekk tbati minn sintomi ta' fibrillazzjoni atrijali (rata tal-polz fi stat mistrieħ eċċezzjonalment għolja (aktar minn 110 taħbita fil-minuta) jew irregolari, mingħajr l-ebda raġuni evidenti, li jagħmilha diffiċli biex titkejjel, - jekk riċentament kellek puplesija (attakk ċerebrali), - jekk tbati ħafif għal moderat minn pressjoni baxxa, - jekk tbati minn pressjoni tad-demm mhux ikkontrollata, speċjalment wara bidla fil-kura tiegħek kontra l-pressjoni għolja, - jekk tbati minn insuffiċjenza severa tal-qalb jew kollass tal-qalb b'anormalità tal-ECG imsejħa 'imblokk tal-fergħa bundle',
English: Treatment with ivabradine was associated with an average reduction in heart rate of 15 bpm from a baseline value of 80 bpm.
Maltese: Il-kura b'ivabradine kienet assoċjata ma' tnaqqis medju fir-rata tal qalb ta' 15 bpm mill-valur tal-linja bażi ta' 80 bpm.
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 Anpharm 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Maltese: jordnalek nofs id-doża, jiġifieri nofs pillola ta' 5 mg ta' Ivabradine Anpharm 5 mg (li tikkorrispondi għal 2.5 mg ta' ivabradine) filgħodu u nofs pillola ta' 5 mg filgħaxija.
English: Concomitant use of ivabradine with heart rate reducing calcium channel blockers such as verapamil or diltiazem is contraindicated (see sections 4.3 and 4.5).
Maltese: L-użu ta' ivabradine huwa kontraindikat flimkien ma' calcium channel blockers li jbaxxu r-ritmu tat taħbit tal-qalb bħal verapamil jew diltiazem (ara sezzjoni 4.3 u 4.5).
English: The total clearance is about 400 ml/min and the renal clearance is about 70 ml/min.
Maltese: madwar 70 mL/min.
English: Ivabradine Anpharm 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Maltese: Pillola miksija b'rita, kulur is-salamun, triangolari, imnaqqxa b'“7.5” fuq naħa waħda u b' fuq in naħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT Ivabradine Anpharm 7.5 mg film-coated tablets ivabradine
Maltese: Ivabradine Anpharm 7.5 mg pilloli miksija b'rita ivabradine
English: Magyarország Servier Hungaria Kft. Tel.: + 36 1 238 77 99
Maltese: Laboratorios Servier S.L. Tel: +34 91 748 96 30
English: OTHER
Maltese: IT-TNEJN
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.
Maltese: Mhemmx evidenza ta' riskju ta' bradikardija (eċċessiva) mar-ritorn għal sinus rhythm meta l kardjoverżjoni farmakoloġika tinbeda f'pazjenti li qed jieħdu ivabradine.
English: NAME OF THE MEDICINAL PRODUCT Ivabradine Anpharm 5 mg film-coated tablets ivabradine
Maltese: Ivabradine Anpharm 5 mg pilloli miksija b'rita ivabradine
English: Excipient with known effect: 61.215 mg lactose monohydrate
Maltese: Eċċipjent b'effett magħruf: 61.215 mg lactose monohydrate Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Therefore, ivabradine is contraindicated during breast-feeding (see section 4.3).
Maltese: Għalhekk ivabradine huwa kontraindikat waqt it-treddigħ (ara sezzjoni 4.3).
English: These data are consistent with the pharmacological effect of ivabradine related to its interaction with hyperpolarisation-activated Ih currents in the retina, which share extensive homology with the cardiac pacemaker If current.
Maltese: Din linformazzjoni hija konsistenti mal-effett farmakoloġiku ta' ivabradine relatat ma' l-interazzjoni tiegħu ma' iperpolarizzazzjoni-attivata tal-kurrenti Ih fir-retina, li jaqsmu omoloġija estensiva ma' kurrent If tal-pacemaker tal-qalb.
English: What Ivabradine Anpharm looks like and contents of the pack Ivabradine Anpharm 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other.
Maltese: Kif jidher Ivabradine Anpharm u l-kontenut tal-pakkett Ivabradine Anpharm 5 mg pilloli huma pilloli miksija b'rita, kulur is-salamun, oblungi, b'sinjal imnaqqax fuq iż-żewġ naħat, imnaqqxin b'“5” fuq naħa waħda u b' fuq in-naħa l-oħra.
English: Ivabradine Anpharm 7.5 mg film-coated tablets
Maltese: Ivabradine Anpharm 7.5 mg pilloli miksija b'rita.
English: The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial 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.
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),
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride)
Maltese: Pillola waħda miksija b'rita fiha 7.5 mg ivabradine (ekwivalenti ghal 8.085 mg bħala ivabradine hydrochloride)
English: Ivabradine is indicated : - in adults unable to tolerate or with a contraindication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Maltese: - f'adulti li ma jistgħux jittolleraw jew li għandhom kontraindikazzjoni għall-użu ta' beta-blockers - jew f'kombinazzjoni ma' beta-blockers f'pazjenti li mhumiex ikkontrollati adegwatament b'doża ottimali ta' beta-blocker.
English: Do not take Ivabradine Anpharm if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Ivabradine Anpharm”).
Maltese: Tiħux Ivabradine Anpharm jekk tista' tinqabad tqila ħlief jekk qed tuża miżuri ta' kontraċezzjoni affidabbli (ara “Tiħux Ivabradine Anpharm”).
English: Ivabradine Anpharm 5 mg film-coated tablets
Maltese: Ivabradine Anpharm 5 mg pilloli miksija b'rita.
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: 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: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine as hydrochloride)
Maltese: Pillola waħda miksija b'rita fiha 5 mg ivabradine (ekwivalenti ghal 5.39 mg bħala ivabradine hydrochloride)
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 fl
English: Ivabradine Anpharm mainly works by reducing the heart rate by a few beats per minute.
Maltese: Ivabradine Anpharm jaħdem billi jnaqqas ir-rata tat-taħbit tal-qalb bi ftit taħbit fil-minuta.
English: Ivabradine Anpharm contains lactose
Maltese: Ivabradine Anpharm fih il-lactose
English: PC:
Maltese: Tel.:
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'
English: Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist (see section 4.4).
Maltese: Il-kura trid titwaqqaf jekk ir-rata tal-qalb tibqa' taħt 50 bpm jew jekk jippersistu s-sintomi ta' bradikardija (ara sezzjoni 4.4).
English: How does Ivabradine Anpharm work?
Maltese: Ivabradine Anpharm.
English: D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
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: If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained.
Maltese: Jekk ir-rata tal-qalb tkun bejn 50 u 60 bpm, għandha tinżamm id-doża ta' 5 mg darbtejn kuljum.
English: Ivabradine Anpharm with food and drink Avoid grapefruit juice during treatment with Ivabradine Anpharm.
Maltese: Ivabradine Anpharm ma' ikel u xorb Evita li tieħu il-meraq tal-grejpfrut meta tkun qed tieħu Ivabradine Anpharm.
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.
English: 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.
Maltese: - jekk qed tieħu mediċini għall-kura ta' infezzjoni fungali (bħal ketoconazole, itraconazole), antibijotiċi ta' tip macrolide (bħal josamycin, clarithromycin, telithromycin jew erythtromycin meħuda mill-ħalq), mediċini għall-kura ta' infezzjonijiet b'HIV (bħal nelfinavir, ritonavir) jew nefazodone (mediċina għall-kura tad-dipressjoni) jew diltiazem, verapamil (użat għall-pressjoni tad-demm għolja jew anġina pectoris);
English: Ivabradine is therefore not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.
Maltese: N-desmethylated ta' ivabradine ġie identifikat bħala s-sustanza attiva maġġura ffurmata filmetaboliżmu fil-bniedem.
English: Concomitant use with precautions - Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4 inhibitors (e.g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate.
Maltese: L-użu ta' ivabradine flimkien ma' impedituri ta' CYP3A4 moderati (eż.fluconazole) jista' jiġi kkunsidrat b'doża tal-bidu ta' 2.5 mg darbtejn kuljum u jekk ir-rata tat-taħbit tal-qalb mistrieħa hija ogħla minn 70 bpm, hemm bżonn li l-pazjent ikun taħt monitoraġġ minħabba ir-rata tat-taħbit tal-qalb.
English: Package leaflet: information for the patient Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets ivabradine
Maltese: - Is-sustanza attiva hi ivabradine (bħala hydrochloride) Ivabradine Anpharm 5 mg: pillola waħda miksija b'rita fiha 5 mg ivabradine (ekwivalenti għal
English: <Overdose (symptoms, emergency procedures, antidotes):>
Maltese: <Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti):>
English: <Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/ >
Maltese: dwar il-Mediċini HYPERLINK "http://www.ema.europa.eu" http://www.ema.europa.eu/.
English: {active substance(s)}
Maltese: {sustanza(i) attiva(i)}
English: <Incompatibilities:>
Maltese: <Inkompatibilitajiet:>
English: <Alternatively you can report via your national reporting system {national system details}.>[For MRP/DCP only]
Maltese: <Tista' wkoll tirrapporta permezz tas-sistema ta' rapportaġġ nazzjonali {dettalji tas-sistema nazzjonali}.> [For MRP/DCP only]
English: <Store in the original <container><package>>
Maltese: <Aħżen <fil-kontenitur> <pakkett> oriġinali>.>
English: Contraindications
Maltese: 7. kontraindikazzjonijiet
English: - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).>
Maltese: - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).>
English: <Batch> <Lot> <BN> {number}
Maltese: <Lott> <lott> {numru}
English: {NATURE/TYPE}
Maltese: {NATURA/TIP}
English: Teл: + 359 {Телефонен номер}
Maltese: + 359 {Телефонен номер}
English: <Store below <25°C> <30°C>.>
Maltese: <Aħżen f'temperatura anqas minn <25(C> <30(C>.>
English: Tel: +370{telefono numeris}
Maltese: +370{telefono numeris}
English: Pharmaceutical form
Maltese: 4. għamla farmaċewtika
English: Statement of the active substance (s) and other ingredients
Maltese: 3. dikjarazzjoni tas-sustanza(i) attiva(i) u ingredjent(i) oħra
English: Name of the veterinary medicinal product
Maltese: 2. isem tal-prodott mediċinali veterinarju
English: {(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>}
Maltese: {L-isem (ivvintat) tal-prodott mediċinali veterinarju <qawwa> għamla farmaċewtika <speċi għal xiex huwa indikat >}
English: Dosage for each species, route(s) and method of administration
Maltese: 10. doża għal kull speċi, mod(i) u metodu ta' amministrazzjoni
English: - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Maltese: - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal)
English: <Fertility:>
Maltese: <Tqala:>
English: <Interaction with other medicinal products and other forms of interaction:>
Maltese: <Interazzjoni ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni:>
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated)
Maltese: - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal)
English: <The frequency of adverse reactions is defined using the following convention:
Maltese: <Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni:
English: <Manufacturer responsible for batch release:>
Maltese: <Manifattur responsabbli għall-ħrug tal-lott:>
English: <Store in a dry place>
Maltese: <Aħżen u ttrasporta ffriżat.>
English: <Special warnings for each target species:>
Maltese: <Prekawzjonijiet speċjali għall-użu:>
English: <Shelf life after <dilution> <reconstitution> according to directions: …..>
Maltese: <Iż-żmien kemm idum tajjeb wara li jiġi <dilwit><imħallat> skont kif rakkomandat: ....>
English: Package size
Maltese: 5. daqs tal-pakkett
English: NL-0000 XX {stad}>
Maltese: NL-0000
English: <Protect from direct sunlight.>
Maltese: <Ipproteġi minn xemx diretta.>
English: - common (more than 1 but less than 10 animals in 100 animals treated)
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal)
English: <in order to protect from <light> <and> <moisture>.>
Maltese: <sabiex tipproteġi mid-<dawl> <u> <l-umdità>.>
English: <Ask your <veterinary surgeon> <or> <pharmacist> how to dispose of medicines no longer required.
Maltese: <Dan il-prodott mediċinali veterinarju m'għandux bżonn ta' kundizzjonijiet ta' ħażna speċjali.>
English: <Store and transport frozen {temperature range}.>
Maltese: <Aħżen u ttrasporta ġo friġġ.>
English: <Store and transport refrigerated (2°C - 8°C).>
Maltese: <Taħżinx f'temperatura 'l fuq minn <25(C> <30(C>.>
English: Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release , if different
Maltese: Il-kliem “għall-kura tal-annimali biss” u kundizzjonijiet jew restrizzjonijiet dwar il-provvista u l-użu, jekk applikabbli
English: Do not use this veterinary medicinal product after the expiry date which is stated on the <label> <bottle> <...> <after {abbreviation used for expiry date}>.
Maltese: Tużax dan il-prodott mediċinali veterinarju wara d-data ta' skadenza murija fuq <it-tikketta> <il-pakkett> <il-flixkun> <...> <wara {taqsira użata għad-data ta' skadenza}>.
English: <Once <broached> <opened> <diluted> <reconstituted> <use by…> <use within…><use immediately.>>
Maltese: <Ladarba <jinfetaħ><jiġi dilwit><jitħallat> <uża fi żmien…> <uża fil-pront>.>
English: Thursday 22 January 2015
Maltese: 22 ta' Jannar 2015
English: Musculoskeletal disorders:
Maltese: Disturbi muskoloskeletali:
English: Paroxetine - Aggression (EPITT no 18089)
Maltese: Paroxetine - Aggressjoni (EPITT no 18089)
English: Frequency ‘not known': aggression
Maltese: Frekwenza ‘mhux magħrufa': aggressjoni
English: Adopted at the 6-9 January 2015 PRAC
Maltese: Adottati fil-PRAC tas-6-9 ta' Jannar 2015
English: Possible side effects:
Maltese: Effetti sekondarji possibbli:
English: Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - Immune-mediated necrotizing myopathy (IMNM) (EPITT no 18140)
Maltese: Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - Mijopatija li tinnekrotizza medjata mis-sistema immunitarja (IMNM) (EPITT nru 18140)
English: Valproate and related substances - Mitochondrial toxicity (EPITT no 17956)
Maltese: Valproate u sustanzi relatati- Tossiċità mitokondrijali (EPITT no 17956)
English: Lithium - Solid renal tumours (EPITT no 18090)
Maltese: 3. Litju - Tumuri renali solidi (EPITT nru 18090)
English: Optimark is contraindicated
Maltese: Optimark huwa kontraindikat
English: Section 2:
Maltese: Sezzjoni 2:
English: Patients with iImpaired renal function
Maltese: Pazjenti b'iIndeboliment tal-funzjoni renali
English: Section 4 Possible side effects:
Maltese: Sezzjoni 4 Effetti sekondarji possibbli:
English: Summary of Product Characteristics (SmPC):
Maltese: Sommarju tal-Karatteristiċi tal-Prodott (SmPC):
English: SmPC changes for Omniscan (gadodiamide) and Magnevist (gadopentetic acid)
Maltese: Bidliet fl-SmPC għal Omniscan (gadodiamide) u Magnevist (aċtu gadopentetiku)
English: Gadodiamide; gadopentetic acid; gadoversetamideNephrogenic systemic fibrosis in patients with acute kidney injury (EPITT no 408)
Maltese: Gadodiamide; aċidu gadopentetiku; gadoversetamideFibrożi nefroġenika sistemika f'pazjenti bi ħsara akuta filkliewi (EPITT nru 408)
English: Renal and urinary disorders:
Maltese: Tumuri renali:
English: POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy, cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.
Maltese: Disturbi relatati ma' POLG għandhom jiġu ssuspettati f'pazjenti bi storja familjali jew b'sintomi li jissuġġerixxu disturb relatat ma' POLG, inklużi iżda mhux biss enċefalopatija mhux spjegata, epilessija refrattorja (fokali, mijoklonika), status epilepticus fil-preżentazzjoni, dewmien fl-iżvilupp, rigressjoni psikomotorili, newropatija axonali sensomotorili, mijopatija, atassja ċerebrali, oftalmopleġja, jew emigranja kkumplikata b'awra oċċipitali.
English: Section 4.8 - Undesirable effects:
Maltese: Sezzjoni 4.8 - Effetti mhux mixtieqa:
English: SmPC changes for Optimark (gadoversetamide) 4.2 Posology and method of administration
Maltese: Bidliet fl-SmPC għal Optimark (gadoversetamide) 4.2 Pożoloġija u metodu ta' kif jingħata
English: • in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury.
Maltese: • f'pazjenti b'indeboliment renali gravi (GFR < 30 ml/min/1.73m2) u/jew bi ħsara akuta fil-kliewi.
English: Frequency unknown: Benign/malignant kidney tumours (microcysts, oncocytoma, or collecting duct renal carcinoma) (in long-term therapy).
Maltese: Tumuri tal-kliewi beninni/malinni (mikroċesti, onkoċitoma, jew karċinoma renali tal-kanal tal-ġbir) (f'terapija fit-tul).
English: Valproate is contraindicated in patients known to have mitochondrial disorders caused by mutations in the nuclear gene encoding the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome, and in children under two years of age who are suspected of having a POLG-related disorder (see section 4.4).
Maltese: Valproate huwa kontraindikat f'pazjenti magħrufin li għandhom disturbi mitokondrijali kkawżati minn mutazzjonijiet fil-ġene nukleari li jikkodifika l-enzima polimerażi mitokondrijali y (POLG), eż. isSindrome ta' Alpers-Huttenlocher, u fit-tfal taħt l-età ta' sentejn li jkunu suspettati li għandhom disturbi relatati ma' POLG (ara sezzjoni 4.4).
English: Frequency unknown: Microcysts, oncocytoma and collecting duct renal carcinoma (in long-term therapy) (see Section 4.4).
Maltese: Mikroċesti, onkoċitoma, jew karċinoma renali tal-kanal tal-ġbir (f'terapija fit-tul) (ara Sezzjoni 4.4).
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m²) and/or acute kidney injury.
Maltese: Kien hemm rapporti ta' fibrożi nefroġenika sistemika (NSF) assoċjata mal-użu ta' Optimark u ma' xi aġenti ta' kuntrast li fihom gadolinium f'pazjenti b'indeboliment renali akut jew kroniku (GFR <30ml/min/1.73m²) u/jew ħsara akuta fil-kliewi.
English: Package leaflet:
Maltese: Frekwenza mhux magħrufa:
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of <invented name> and some other gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury.
Maltese: Kien hemm rapporti ta' fibrożi nefroġenika sistemika (NSF) assoċjata mal-użu ta' <isem ivvintat> u ta' xi aġenti ta' kuntrast li fihom gadolinium f'pazjenti b'indeboliment renali akut jew kroniku (GFR <30ml/min/1.73m²) u/jew ħsara akuta fil-kliewi.
English: Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Maltese: Qabel jingħata Optimark, il-pazjenti kollha għandhom jiġu skrinjati għal disfunzjoni renali billi jsiru testjiet fil-laboratorji.