FrancophonIA/ELRC3.0 huggingface dataset:
English: In the TAP study in all lesion types, the average number of treatments per year were 3.5 in the first year after diagnosis and 2.4 in the second for the randomised placebo-controlled phase and 1.3 in the third year, 0.4 in the fourth and 0.1 in the fifth year for the open-label extension phase.
Maltese: Fl-istudju TAP fit-tipi kollha ta' leżjonijiet, in-numru ta' kuri fis-sena kienu 3.5 fl-ewwel sena wara ddijanjosi u 2.4 fit-tieni għall-fażi randomizzata kkontrollata bi plaċebo u 1.3 fit-tielet sena, 0.4 fir-raba' u 0.1 fil-ħames sena għall-fażi ta' l-estensjoni open-label.
English: For a dose of 6 mg/m body surface (the dose recommended for the treatment) dilute the required amount of Visudyne solution in dextrose 50 mg/ml (5 %) solution for infusion to a final volume of 30 ml.
Maltese: Għal doża ta' 6 mg/m superfiċje talġisem (id-doża rakkomandata għall-kura) idilwixxi l-ammont tas-soluzzjoni Visudyne meħtieġ fildestrożju 50 mg/ml (5%) soluzzjoni għall-infużjoni għal volum finali ta' 30 ml.
English: The VIP-AMD included patients with occult with no classic subfoveal CNV with a visual acuity score of >50 letters (20/100).
Maltese: Il-VIP-AMD kien jinkludi pazjenti b'okkult mingħajr CNV subfoveali klassiku b'punteġġ ta' akutezza viżwali ta' > 50 ittra (20/100).
English: Two randomised, placebo-controlled, double-masked, multicentre, 24-month studies (BPD OCR 003 AMD, or Verteporfin in Photodynamic Therapy-AMD [VIP-AMD], and BPD OCR 013, or Visudyne in Occult Choroidal Neovascularisation [VIO]) were conducted in patients with AMD characterised by occult with no classic subfoveal CNV.
Maltese: Fil-fatt, saru żewġ studji randomizzata, ikkontrollati bi plaċebo, double-masked, multiċentriċi li damu 24 xahar (BPD OCR 003 AMD jew Verteporfin f'Terapija Fotodinamika- AMD [VIP-AMD] u BPD OCR 013 jew Visudyne Neovaskularizzazzjoni Korojdali Okkulta
English: In the VIP-PM study in pathological myopia, the average number of treatments per year were 3.5 in the first year after diagnosis and 1.8 in the second for the randomised placebo-controlled phase and 0.4 in the third year, 0.2 in the fourth and 0.1 in the fifth year for the open-label extension phase.
Maltese: Fl-istudju VIP-PM f'mijopja farmakoloġika, in-numru medju ta' kuri fis-sena kien 3.5 fl-ewwel sena wara d-dijanjosi u 1.8 fit-tieni għall-fażi randomizzata kkontrollata bi plaċebo u 0.4 fit-tielet sena, 0.2 fir-raba' u 0.1 fil-ħames għall-fażi ta' l-estensjoni open-label.
English: Visudyne contains small amounts of butylated hydroxytoluene (E321) This ingredient is irritant to eyes, skin and mucous membranes.
Maltese: Visudyne fih ammonti żgħar ta' butylated hydroxytoluene (E321) Din is-sustanza hija irritanti għall-għajnejn, għal ġilda u għal membrani mukużi.
English: At the recommended light intensity of 600 mW/cm2, it takes 83 seconds to deliver the required light dose of
Maltese: Bl-intensità ta' dawl rrikmandata ta' 600 mW/ċm2, din tieħu 83 sekonda biex tagħti id-doża meħtieġa ta' 50
English: The nasal edge of the treatment spot must be at least 200 m from the temporal edge of the optic disc.
Maltese: Ix-xifer nażali tal-parti li se tiġi kkurata għandha tkun mill-anqas 200 m mix-xifer temporali tad-diska ottika.
English: • The second step is the activation of Visudyne in the eye 15 minutes after the start of the infusion.
Maltese: • It-tieni stadju huwa l-attivazzjoni ta' Visudyne fil-għajn 15 -il minuta wara l-bidu tal-infużjoni.
English: Elderly (65 years of age or above)
Maltese: Anzjani (minn 65 sena ‘l fuq)
English: Verteporfin and its diacid metabolic are excreted in human milk in low amounts.
Maltese: Verteporfin u l-metabolu diaċidu tiegħu jiġu eskretati fil-ħalib tal-mara f'ammonti żgħar.
English: A group of patients who had occult with no classic lesions (n=258) showed a statistically significant difference of 13.7% in favour of Visudyne compared to placebo (45.2% versus 31.5%, p=0.032).
Maltese: Fl-24 xahar, ġiet osservata differenza statistikament sinifikanti ta' 12.9% favur Visudyne imqabbel ma' plaċebo (46.2% kontra 33.3%, p=0.023). Grupp ta' pazjenti li kellhom leżjonijiet okkulti iżda mhux klassiċi (n=258), urew differenza statistikament sinifikanti ta' 13.7% favur Visudyne imqabbel ma' plaċebo (45.2% kontra 31.5%, p=0.032). Perċentwali ogħla ta' pazjenti li rċevew Visudyne meta mqabbel ma' plaċebo (45.2% kontra 31.5%, p=0.032).
English: Prolonged exposure to light from light-emitting medical devices such as pulse oximeters should also be avoided for 48 hours following Visudyne administration.
Maltese: Id-doża ta' lejżer meħtieġa biex tattiva Visudyne tintlaħaq fi 83 sekonda.
English: The pharmacokinetics of verteporfin have been reported to be similar in healthy Caucasian and Japanese men after a dose of 6 mg/m2 by a 10-minute infusion.
Maltese: Il-farmakokinetiċi ta' verteporfin kienu rrappurtati li jixxiebhu fi rġiel Kawkażjatiċi u Ġappuniżi b'saħħithom wara doża ta' 6 mg/m wara infużjoni ta' 10 minuti.
English: However the pharmacological characteristics do not indicate any need to adjust the dose (see “Biotransformation” and “Elimination” under section 5.2).
Maltese: Madanakollu il-karatteristiċi farmaċewtiċi ma jindikaw l-ebda bżonn li tiġi aġġustata d-doża (ara “Bijotrasformazzjoni” u “Eliminazzjoni” taħt sezzjoni 5.2).
English: In the event of recurrent CNV leakage, Visudyne therapy may be given up to 4 times per year.
Maltese: Jekk ikun hemm bżonn, it-terapija b'Visudyne tista' tiġi ripetuta kull 3 xhur, sa 4 darbiet fis-sena.
English: General symptoms can include headache, malaise, syncope, hyperhydrosis, dizziness, rash, urticaria, pruritus, dyspnoea, flushing, and changes in blood pressure and heart rate.
Maltese: Sintomi ġenerali jistgħu jinkludu uġigħ ta' ras, malaise, sinkope, iperidrożi, sturdament, raxx, urtikarja, prurite, dispneja, fwawar u tibdil fil-pressjoni tad-demm u fir-rata tat-taħbit tal-qalb.
English: Chest pain, vasovagal reactions and hypersensitivity reactions related to Visudyne infusion have been reported.
Maltese: Ġew irrappurtati episodji ta' wġigħ fis-sider, reazzjonijiet vażovagali nnifishom, u reazzjonijiet ta' sensittività eċċessiva relatati mal-infużjoni ta' Visudyne.
English: What Visudyne is used for Visudyne is used to treat the wet form of age-related macular degeneration and pathological myopia.
Maltese: Visudyne jintuża sabiex jikkura l-wet form ta' diġenerazzjoni makulari marbuta ma' l-età u mijopija patoloġika.
English: It is not known how the potential for DNA damage with PDT agents translates into human risk.
Maltese: Mhux magħruf kif il-potenzjal ta' ħsara tad-DNA b'aġenti PDT jittraduċi ruħu bħala riskju għall-bniedem.
English: No effect on male or female fertility has been observed in rats following intravenous verteporfin doses of up to 10 mg/kg/day (approximately 60 and 40-fold human exposure at 6 mg/m based on AUCinf in male and female rats, respectively).
Maltese: Ma kienx hemm effett fuq il-fertilità tal-irġiel jew in-nisa f'firien wara dożi ta' 10 mg/kg/kuljum verteporfin minn ġol-vina (madwar 60 u 40 darba aktar l-espożizzjoni tal-bniedem jiġifieri ta' 6 mg/m skont l-AUCinf f'firien irġiel u nisa, rispettivament.)
English: The reaction occurred mainly in patients with occult only (4.9 %) or minimally classic CNV lesions in patients with AMD and was not reported for placebo-treated patients.
Maltese: Ir-reazzjonijiet seħħew l-aktar f'pazjenti b'leżjonijiet okkulti biss (4.9%) jew b'leżjonijiet CNV minimament klassiċi f'pazjenti b'AMD u ma kinitx irrapurtata għal pazjenti kkurati bil-plaċebo.
English: Visudyne is used for the treatment of predominantly classic choroidal neovascularisation in adults with age-related macular degeneration, and also for the treatment of all types of choroidal neovascularisation in adults with pathological myopia.
Maltese: Użu fit-tfal Visudyne huwa kura għall-adulti biss u mhux indikat għall-użu fit-tfal.
English: Fundus cameras with a magnification within the range of 2.4 - 2.6X are recommended.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Fotosensittività u espożizzjoni għad-dawl
English: Another efficacy parameter was also defined: the proportion of patients who lost less than 30 letters (equivalent to 6 lines) of visual acuity at months 12 and 24 relative to baseline.
Maltese: Parametru ta' l-effikaċja ieħor kien iddefinit ukoll: ilproporzjon ta' pazjenti li tilfu anqas minn 30 ittra (ekwivalenti għal 6 linji) fl-akutezza viżwali fit-12-il xahar u fl-24 meta mqabbel mal-linja bażi.
English: There were no teratogenic effects observed in rabbits at doses up to 10 mg/kg/day (approximately 20-fold human exposure at 6 mg/m based on body surface area).
Maltese: Ma kienx hemm effetti teratoeġeniċi fi fniek b'dożi ta' 10 mg/kg/kuljum (madwar 20 darba aktar l-espożizzjoni tal-bniedem jiġifieri ta' 6 mg/m skont is-superfiċje tal-bniedem).
English: 2, visual impairment such as reduced visual acuity, blurred, fuzzy vision, or photopsia, visual field defect such as scotoma, grey or dark haloes and black spots.
Maltese: 2, indeboliment fil-vista bħal tnaqqis fl-akutezza tal-vista, vista imċajpra, mżellġa, jew fotopsja, difett fil-kamp tal-vista bħal skotoma, dwawar griżi jew suwed u tikek suwed.
English: Caution should therefore be exercised when using Visudyne concomitantly with other photosensitising medicinal products (see “Photosensitivity and exposure to light” under section 4.4).
Maltese: Għalhekk għanda tintuża lkawtela meta Visudyne jintuża b'mod konkomitanti ma' prodotti mediċinali oħra fotosensitizzanti (ara “Il-fotosensittività u l-espożizzjoni għad-dawl” taħt is-sezzjoni 4.4).
English: In whole human blood, 90% of verteporfin is associated with plasma and 10 % associated with blood cells, of which very little was membrane associated.
Maltese: Fid-demm komplet uman, 90% ta' verteporfin jassoċja mal-plażma u 10% jassoċja maċ-ċelluli taddemm, li minnu ammont żgħir ħafna assoċja mal-membrana.
English: Age-related macular degeneration with predominantly classic subfoveal lesions
Maltese: Deġenerazzjoni makulari marbuta ma' l-età b'leżjonijiet subfoveali prinċipalment klassiċi
English: • Eye disorders: bleeding of the retina or into the vitreous humour (the clear gel-like substance that fills the eyeball behind the lens), swelling or fluid retention in the retina and displacement of the retina in the treated eye.
Maltese: • Disturbi fl-għajnejn: fsada tar-retina jew tal-vitreous humour (is-sustanza ċara qisha ġel li timla l-boċċa tal-għajn minn wara l-lenti), nefħa jew żamma ta' fluwidu u ċ-ċaqliq tar-retina filgħajn li tkun qed tiġi kkurata.
English: • Eye disorders: severe decrease of vision (loss of 4 lines or more within 7 days of treatment), visual disturbances such as blurred, hazy or fuzzy vision, flashes of light, decreased vision, and a change in the field of vision in the treated eye such as grey or dark shadows, blind spots or black spots.
Maltese: • Disturbi fl-għajnejn: tnaqqis sever fil-vista (telf ta' 4 linji jew aktar fi żmien 7 ijiem mill-kura), disturbi fil-vista bħal vista mċajpra, mhux ċara jew mżellġa, beraq ta' dawl, tnaqqis fil-vista, u tibdil fil-kamp tal-vista fil-għajn li tkun qed iġi kkurata bħal dellijiet griżi jew skuri, tikek għomja jew tikek suwed.
English: OTHER
Maltese: Loppju
English: A higher percentage of patients who received Visudyne, compared with those who received placebo, experienced adverse events (88.1% versus 81.7%), associated adverse events (23.0% versus 7.5%), events leading to discontinuation (11.9% versus 3.3%) and events leading to death (n=10 [4.1%] versus n=1 [0.8%]).
Maltese: każijiet li wasslu għat-twaqqif (11.9% kontra 3.3%) u każijiet li wasslu għall-mewt (n=10 [4.1%] kontra n=1 [0.8%]).
English: Agents which increase verteporfin uptake in the vascular endothelium
Maltese: Aġenti li jżidu l-assorbiment ta' verteporfin mill-endoteljum vaskulari
English: Reconstituted Visudyne is an opaque dark green solution.
Maltese: Visudyne rikostitwit huwa soluzzjoni ħadra skura opaka.
English: The primary efficacy variable was responder rate, defined as the proportion of patients who lost less than 15 letters (equivalent to 3 lines) of visual acuity (measured with the ETDRS charts) at month 12 relative to baseline.
Maltese: Il-varjant primarju ta' l-effikaċja kien ir-rata ta' rispons, iddefinit bħala l-proporzjon ta' pazjenti li tilfu anqas minn 15-il ittra (ekwivalenti għal 3 linji) ta' l-akutezza viżwali (imkejla bit-tabelli ETDRS) fixxahar numru 12 b'relazzjoni mal-linja bażi.
English: Verteporfin exposure is not significantly increased in patients with mild hepatic impairment (see “Biotransformation” and “Elimination” under section 5.2) and does not require any dose adjustment.
Maltese: L-espożizzjoni ta' verteporfin ma tiżdiedx b'mod sinnifikanti f'pazjenti b'indeboliment epatiku ħafif (ara “Bijotrasformazzjoni” u “Eliminazzjoni” taħt sezzjoni 5.2) u ma teħtieġ l-ebda aġġustament fid-doża.
English: Other photosensitising agents
Maltese: Aġenti fotosensitizzanti oħrajn
English: Name and address of manufacturer responsible for batch release
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott
English: What Visudyne is
Maltese: X'inhu Visudyne
English: Each vial contains 15 mg of verteporfin
Maltese: Kull kunjett fih 15 mg ta' verteporfin
English: In a study of patients with mild hepatic impairment (defined as having two abnormal hepatic function tests at enrolment), AUC and Cmax were not significantly different from the control group.
Maltese: Fi studju fost pazjenti b'indeboliment epatiku ħafif (iddefinit bħala li għandu żewġ testijiet mhux normali tal-funzjoni tal-fwied mas-sħubija), l-AUC u s-Cmax ma kenux differenti b'mod sinjifikanti minn dawk fost il-grupp tal-kontroll.
English: Presence of occult CNV lesions (fluorescence not well demarcated on the angiogram) was allowed.
Maltese: Ġiet aċċettata preżenza ta' leżjonijiet okkulti tas-CNV (fluworexxenza mhux iddemarkata sew fuq l-anġjogramma).
English: There are no human fertility data for verteporfin.
Maltese: M'hemm l-ebda tagħrif dwar il-fertilità umana għal verteporfin.
English: Injection site hypersensitivity, injection site haemorrhage, injection site discoloration, pyrexia, pain.
Maltese: Sensittività eċċessiva fis-sit tal-injezzjoni, emorraġija fis-sit talinjezzjoni, telf ta' kulur fis-sit tal-injezzjoni, deni, uġigħ.
English: Patients of reproductive age should be made aware of the lack of fertility data, and Visudyne should only be given after consideration of individual risks and benefits.
Maltese: Pazjenti ta' età riproduttiva għandhom ikunu infurmati dwar in-nuqqas ta' dejta dwar il-fertilità, u Visudyne għandu jingħata biss wara li jiġu kkunsidrati r-riskji u l-benefiċċji individwali.
English: At month 12, there was a benefit of Visudyne for the primary efficacy endpoint (percentage of patients who lost less than 3 lines of visual acuity) - 86% for Visudyne versus 67% for placebo, p=0.011.
Maltese: Fit-12-il xahar, kien hemm benefiċċju ta' Visudyne għall-fini ta' l-effikaċja primarja (perċentwali ta' pazjenti li tilfu anqas minn 3 linji ta' l-akutezza viżwali) - 86% għal Visudyne kontra 67% għallplaċebo, p=0.011. Il-perċentwali ta' pazjenti li tilfu anqas minn 1.5 linji kienet 72% għal Visudyne u 44% għall-plaċebo (p=0.003).
English: Retinal ischaemia (retinal or choroidal vessel non-perfusion).
Maltese: Iskemija tar-retina, non-perfużjoni tal-vina jew l-arterja tar-retina jew korojdali.
English: Visudyne contains the active substance verteporfin, which is activated by light from a laser in a treatment called photodynamic therapy.
Maltese: Visudyne fih is-sustanza attiva verteporfin, li hija attivata minn dawl li joħroġ minn lejżer f'kura msejjħa terapija fotodinamika.
English: Delpharm Huningue S.A.S.
Maltese: TA' KIF JINGĦATA
English: Photosensitivity reactions (in 2.2 % of patients and <1 % of Visudyne courses) occurred in the form of sunburn following exposure to sunlight, usually within 24 hours from Visudyne treatment.
Maltese: Reazzjonijiet ta' fotosensittività (fi 2.2% tal-pazjenti u <1% tal-korsijiet ta' Visudyne) seħħew bħala ħruq mix-xemx wara espożizzjoni għad-dawl tax-xemx, normalment fi żmien 24 siegħa mill-kura b'Visudyne.
English: (See section 4.5)
Maltese: (Ara sezzjoni 4.5)
English: (See sections 4.4, 4.6 and 4.8)
Maltese: (Ara sezzjonijiet 4.4, 4.6 u 4.8)
English: [Product name]
Maltese: [Isem il-prodott]
English: Pharmacotherapeutic class: selective calcium inhibitors with vascular effects, ATC code: C08CA04
Maltese: Kategorija farmakoterapewtika: inibituri selettivi tal-kalċju b'effetti vaskulari, Kodiċi ATC: C08CA04
English: The active substance is nicardipine.
Maltese: Is-sustanza attiva hi nicardipine.
English: Nicardipine is metabolized by cytochrome P450 3A4.
Maltese: Nicardipine hu metabolizzat minn ċitokrom P450 3A4.
English: Your doctor will take special care:
Maltese: Doża ta' manteniment:
English: • Malignant arterial hypertension/Hypertensive encephalopathy
Maltese: • Pressjoni għolja arterjali malinna/Enċefalopatija ipertensiva
English: Maintenance dose: The maintenance dosage of 1 to 4 mcg/kg/min is recommended.
Maltese: Hu rakkomandat dożaġġ ta' manteniment ta' 1 sa 4 mcg/kg/min.
English: Combination with beta-blockers
Maltese: Kombinazzjoni ma' imblokkaturi beta
English: Competitive neuromuscular blockers
Maltese: Imblokkaturi newromuskolari kompetittivi
English: Frequency categories are defined according to the following convention: 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) and not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Initial dose: In case of emergency, a starting dose of 0.5 to 5 mcg/kg/min is recommended
Maltese: F'każ ta' emerġenza, hi rakkomandata doża inizjali ta' 0.5 sa 5 mcg/kg/min.
English: If you are under 18 years of age
Maltese: Jekk għandek inqas minn 18-il sena
English: None of the dose was recovered as unchanged nicardipine in the urine.The elimination profile of the drug following an intravenous dose consists of three phases, with corresponding half-life: alpha 6.4 min, beta 1.5 hours, gamma 7.9 hours.
Maltese: Il-profil ta' eliminazzjoni tal-mediċina wara l-għoti tad-doża minn ġol-vini jikkonsisti fi tliet fażijiet, b'half-life korrispondenti: alpha 6.4 min, beta 1.5 sigħat, gamma 7.9 sigħat.
English: The pharmacokinetics of intravenously administration of nicardipine was studied in subjects with severe renal dysfunction requiring hemodialysis (creatinine clearance < 10 ml/min), mild/moderate renal dysfunction (creatinine clearance 10 - 50 mi/min) and normal renal function (creatinine clearance >50 ml/min).
Maltese: Il-farmakokinetika tal-għoti ta' nicardipine minn ġol-vini ġiet studjata f'individwi b'disfunzjoni severa tal-kliewi li kellhom bżonn ta' emodijalisi (tneħħija tal-krejatinina < 10 ml/min), disfunzjoni tal-kliewi ħafifa/moderata (tneħħija tal-krejatinina 10-50 ml/min) u funzjoni normali tal-kliewi (tneħħija talkrejatinina > 50 ml/min).
English: (Frequency unknown)
Maltese: (Frekwenzi mhux magħrufa)
English: Not applicable.
Maltese: Mhux rilevanti.
English: There were no significant differences in the principal pharmacokinetic parameters between severe renal dysfunction and normal renal function (see section 4.4)
Maltese: Ma kien hemm ebda differenzi sinifikanti fil-parametri farmakokinetiċi prinċipali bejn id-disfunzjoni severa tal-kliewi u l-funzjoni normali tal-kliewi (ara sezzjoni 4.4).
English: Co-administration of CYP 3A4 enzyme-inducing agents (e.g.carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone and rifampicin) may cause a decrease in the plasma concentrations of nicardipine.
Maltese: L-għoti flimkien ta' sustanzi li jinduċu l-enzimi ta' CYP 3A4 (eż. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone u rifampicin) jista' jikkawża tnaqqis fil-konċentrazzjonijiet ta' nicardipine fil-plażma.
English: Common - orthostatic hypotension
Maltese: Komuni - pressjoni baxxa ortostatika
English: In case of an overdose it is recommended to use routine measures including monitoring of cardiac and respiratory function.
Maltese: F'każ ta' doża eċċessiva, hu rakkomandat li tuża miżuri ta' rutina inkluż monitoraġġ tal-funzjoni talqalb u dik respiratorja.
English: prazosin and terazosin - Any other medicine for high blood pressure - Cimetidine (to treat indigestion or stomach ulcers) - Digoxin (used for heart conditions) - Amifostine (used to protect against the harmful effects of certain cancer treatments) - Medicines to treat depression, anxiety or other mental health problems - Strong painkilling medicines like morphine or codeine - Medicines used to treat inflammation such as steroids and tetracosactide - Magnesium injection (used to treat severe high blood pressure in pregnancy)
Maltese: Digoxin (użat għall-kura tal-kundizzjonijiet tal-qalb) Amifostine (użat għall-protezzjoni kontra l-effetti dannużi ta' ċerti kuri tal-kanċer) Mediċini għall-kura tad-dipressjoni, ansjetà jew problemi oħra tas-saħħa mentali Mediċini qawwija għal kontra l-uġigħ bħal morfina jew kodeina Mediċini użati għall-kura tal-infjammazzjoni bħal sterojdi u tetracosactide Injezzjoni ta' magnesium (użata għall-kura ta' pressjoni tad-demm għolja severa waqt it-tqala)
English: Nicardipine may enhance the negative inotropic effect of beta-blockers and may cause heart failure in patient with latent or uncontrolled heart failure (see section 4.4)
Maltese: Nicardipine jista' jsaħħaħ l-effett inotropiku negattiv tal-imblokkaturi beta u jista' jikkawża insuffiċjenza tal-qalb f'pazjenti b'insuffiċjenza tal-qalb moħbija jew mhux ikkontrollata (ara sezzjoni 4.4).
English: Overdose with nicardipine hydrochloride can potentially result in marked hypotension, bradycardia, palpitations, flushing, drowsiness, collapse, peripheral oedema, confusion, slurred speech and hyperglycaemia.
Maltese: Doża eċċessiva b'nicardipine hydrochloride tista' potenzjalment tirriżulta fi pressjoni baxxa notevoli, bradikardija, palpitazzjonijiet, fwawar, ngħas, kollass, edema periferali, konfużjoni, taħdit ma jinftiehemx u ipergliċemija.
English: Nicardipine is contra-indicated in unstable angina and immediately following myocardial infarction (see section
Maltese: Nicardipine hu kontraindikat f'anġina instabbli u immedjatament wara infart mijokardijaku (ara sezzjoni 4.3)
English: Unstable angina
Maltese: Jekk għandek anġina
English: Within 8 days after myocardial infarction
Maltese: Fi żmien 8 ijiem wara infart mijokardijaku
English: Acute pulmonary oedema has been observed when nicardipine has been used as tocolytic during pregnancy (see section 4.8), especially in cases of multiple pregnancy (twins or more), with the intravenous route and/or concomitant use of beta-2 agonists.
Maltese: Edema pulmonari akuta ġiet osservata meta nicardipine intuża bħala tokolitiku waqt it-tqala (ara sezzjoni 4.8), speċjalment f'każijiet ta' tqala multipla (tewmin jew aktar), bir-rotta ta' ġol-vina u/jew flimkien mal-użu ta' antagonisti tal-beta-2.
English: Severe aortic stenosis
Maltese: Stenożi aortika severa
English: After coadministration of a radioactive intravenous dose of nicardipine with an oral 30 mg dose given every 8 hours, 49% of the radioactivity was recovered in the urine and 43% in the feces within 96 hours.
Maltese: Wara l-għoti flimkien ta' doża radjoattiva ta' nicardipine ġol-vini flimkien ma' doża ta' 30 mg mogħtija mill-ħalq kull 8 sigħat, 49% tar-radjoattività kienet irkuprata fl-awrina u 43% fl-ippurgar fi żmien 96 siegħa.
English: Concomitant administration of nicardipine and cyclosporine, tacrolimus or sirolimus results in elevated plasma cyclosporine/tacrolimus levels.
Maltese: L-għoti flimkien ta' nicardipine u cyclosporine, tacrolimus jew sirolimus jirriżulta f'livelli għolja ta' cyclosporine/tacrolimus fil-plażma.
English: Rare cases of abnormal hepatic function possibly associated with the use of nicardipine have been reported.
Maltese: Ġew irrappurtati każijiet rari ta' funzjoni anormali tal-fwied possibbilment assoċjati mal-użu ta' nicardipine.