FrancophonIA/ELRC3.0 huggingface dataset:
English: (Mechanism unknown)
Maltese: (Mekkaniżmu mhux magħruf)
English: No clinically relevant changes were observed in the total Cmax and AUC of isavuconazole in subjects with mild, moderate or severe renal impairment compared to subjects with normal renal function.
Maltese: Ma ġewx osservati bidliet klinikament rilevanti fis-Cmax totali u l-AUC ta' isavuconazole f'individwi b'indeboliment ħafif, moderat jew sever tal-kliewi meta mqabbla ma' individwi b'funzjoni tal-kliewi.
English: For detailed instructions on the reconstitution and dilution of CRESEMBA before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq ir-rikostituzzjoni u d-dilwazzjoni tal-prodott mediċinali qabel lamministrazzjoni, ara sezzjoni 6.6.
English: The inactive cleavage product is primarily eliminated by metabolism and subsequent renal excretion of the metabolites.
Maltese: Il-prodott inattiv li joħroġ mill-ksur jiġi eliminat prinċipalment b'metaboliżmu u eliminazzjoni sussegwenti mill-kliewi tal-metaboliti.
English: Concomitant use of CRESEMBA with CYP3A4 substrates such as the immunosuppressants tacrolimus, sirolimus or ciclosporin may increase the systemic exposure to these medicinal products.
Maltese: L-użu fl-istess waqt ta' CRESEMBA ma' sottostrati ta' CYP3A4 bħallimmunosopressanti tacrolimus, sirolimus jew ciclosporin jista' jżid l-esponiment sistemiku ta' dawn il-prodotti mediċinali.
English: In utero exposure to the active moiety isavuconazole had no effect on the fertility of the surviving pups.
Maltese: Esponiment in utero tal-porzjon attiv isavuconazole ma kellux effett fuq il-fertilità tal-frieħ sopravissuti.
English: (CYP3A4/5 induction)
Maltese: (induzzjoni ta' CYP3A4/5)
English: Do not swallow the desiccant.
Maltese: Ġestjoni ta' doża eċċessiva
English: Your doctor should monitor you for possible side effects
Maltese: It-tabib tiegħek ser jissorveljak għal effetti sekondarji possibbli
English: Smoking cessation aids Bupropion (CYP2B6 substrate)
Maltese: Għajnuniet għal waqfien mit-tipjip Bupropion (sottostrat ta' CYP2B6)
English: Common Vomiting; Diarrhoea; Nausea; Abdominal pain^ Uncommon Dyspepsia; Constipation; Abdominal distension Hepatobiliary disorders
Maltese: QT imqassar fl-elekrokardjogramma; Takikardja supraventrikulari; ekstrasistoles ventrikulari; ekstrasistoles supraventrikulari
English: What Cresemba looks like and contents of the pack Cresemba 100 mg hard capsules are capsules with a reddish-brown body marked with “100” in black ink and a white cap marked with “C” in black ink.
Maltese: Cresemba 100 mg kapsuli ibsin huma kapsuli ta' lewn kannella fl-aħmar immarkati b'”100” f'linka sewda u għatu abjad immarkat b'”C” b'linka sewda.
English: Ketoconazole (strong CYP3A4/5 inhibitor)
Maltese: Antifungali Ketoconazole (Impeditur qawwi ta' CYP3A4/5)
English: Environmental risk assessment has shown that Cresemba may pose a risk for the aquatic environment.
Maltese: Valutazzjoni tar-riskju ambjentali wriet li Cresemba jista' jkun ta' riskju għall-ambjent akwatiku.
English: Carton for vial for 200 mg powder for concentrate for solution for infusion
Maltese: Kartuna għall-kunjett għal 200 mg trab konċentrat għal soluzzjoni għall-infużjoni
English: Co-administration with high-dose ritonavir (>200 mg twice daily) is contraindicated, as at high doses ritonavir may induce CYP3A4/5 and decrease isavuconazole plasma concentrations (see section 4.3).
Maltese: L-għoti ma' doża għolja ta' ritonavir (200 mg jew aktar darbtejn kuljum) hu kontraindikat, peress li f'dożi għoljin ritonavir jista' jinduċi CYP3A4/5 u jnaqqas il-konċentrazzjonijiet ta' isavuconazole filplażma (ara sezzjoni 4.3).
English: Cresemba is used in adults to treat the following fungal infections: - invasive aspergillosis, caused by a fungus in the ‘Aspergillus' group; - mucormycosis, caused by a fungus beloning to the ‘Mucorales' group in patients for whom a treatment with amphotericin B is not appropriate.
Maltese: - Asperġillosi invażiva, ikkaġunata minn fungu li jappartjeni għal grupp ‘Aspergillus'; - mukormikosi ikkaġunat minn fungu li jappartjeni għall-grupp ta' ‘Mucorales' f'pazjenti li għalihom trattament b'amphotericin B mhux adattat.
English: Metformin: dose reduction may be required.
Maltese: Metformin: tnaqqis fid-doża jista' jkun meħtieġ.
English: For individual Mucorales species, the clinical efficacy data are very limited, often to one or two patients (see section 5.1).
Maltese: Għal speċijiet Mucorales, id-dejta dwar l-effikaċja klinika hija limitata ħafna, ħafna drabi għal pazjent wieħed jew tnejn (ara sezzjoni 5.1).
English: n=1, Actinomucor elegans n=1).
Maltese: L-esperjenza klinika bi speċi oħrajn hija ristretta ħafna (Lichtheimia spp. n=2. Cunninghamella spp. n-1, Actinomucor elegans n=1).
English: Cresemba is available in cartons that contain 14 capsules.
Maltese: Cresemba jiġi f'kartun li fih 14-il kapsula.
English: Indinavir (CYP3A4/5 strong inhibitor and substrate)
Maltese: Indinavir (Impeditur qawwi u sottostrat ta' CYP3A4/5)
English: Rifampicin (strong CYP3A4/5 inducer)
Maltese: Antibatteriċi Rifampicin (induttur qawwi ta' CYP3A4/5)
English: How to store Cresemba
Maltese: Ma ġewx studjati.
English: Unimedic Pharma AB Sími: +46 (0) 10-130 99 50
Maltese: Sími: +46 (0) 10-130 99 50
English: Reconstitution
Maltese: Antaċidi
English: Storage conditions after reconstitution and dilution are provided in section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni u d-dilwizzjoni, ara sezzjoni 6.3.
English: Co-administration of CRESEMBA with the strong CYP3A4/5 inhibitor ketoconazole is contraindicated, since this medicinal product can significantly increase plasma concentrations of isavuconazole (see sections 4.3 and 4.5).
Maltese: L-għoti fl-istess waqt ta' CRESEMBA mal-impeditur qawwi ta' CYP3A4/5 ketoconazole hu kontraindikat peress li dan il-prodott mediċinali jista' jgħolli b'mod sinifikanti l-konċentrazzjonijiet ta' isavuconazole fil-plażma (ara sezzjonijiet 4.3 u 4.5).
English: In rats and rabbits, isavuconazole at systemic exposures below the therapeutic level were associated with dose-related increases in the incidence of skeletal anomalies (rudimentary supernumerary ribs) in offspring.
Maltese: Fil-firien u l-fniek, isavuconazole f'esponimenti sistemiċi taħt il-livell terapewtiku kienu assoċjati ma' żidiet relatati mad-doża fl-inċidenza ta' anomaliji skeletriċi (kustilji supernumerari rudimentari) filfrieħ.
English: METHOD OF ADMINISTRATION
Maltese: Mekkaniżmu ta' reżistenza
English: Co-administration of medicinal products which are inhibitors of CYP3A4 and/or CYP3A5 may increase the plasma concentrations of isavuconazole.
Maltese: L-għoti flimkien ma' prodotti mediċinali li huma indutturi ta' CYP3A4 u/jew CYP3A5 jista' jnaqqas il-konċentrazzjonijiet ta' isavuconazole fil-plażma.
English: Fungal strains with reduced in vitro susceptibility to isavuconazole have been reported, and cross-resistance with voriconazole and other triazole antifungal agents cannot be excluded.
Maltese: Ġew irrapportati razez fungali b'suxxetibilità mnaqqsa għal isavuconazole in vitro, u reżistenza inkroċjata b'voriconazole u sustanzi antifungali oħrajn bi triazole ma tistax tiġi eskluża.
English: CRESEMBA 200 mg powder for concentrate for solution for infusion
Maltese: CRESEMBA 200 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: (CYP3A4/5 substrates)
Maltese: (impediment ta' CYP3A4/5)
English: In particular, do not take this medicine and tell your doctor or pharmacist if you are taking any of the following medicines: - ketoconazole, used for fungal infections, - high doses of ritonavir (400 mg every 12 hours), used for HIV, - rifampicin, rifabutin, used for tuberculosis, - carbamazepine, used for epilepsy, - barbiturate medicines like phenobarbital, used for epilepsy and sleep disorders, - phenytoin, used for epilepsy, - St John's wort, a herbal medicine used for depression, - efavirenz, etravirine, used for HIV, - nafcillin, used for bacterial infections.
Maltese: B'mod partikolari, m'għandekx tieħu din il-mediċina u għarraf lit-tabib jew l-ispiżjar tiegħek jekk qed tieħu xi wieħed mill-mediċini li ġejjin: - ketoconazole, użat għal infezzjonijiet fungali, - dożi għoljin ta' ritonavir (400 mg kull 12-il siegħa), użat għal HIV, - rifampicin, rifabutin, użat għal tuberkulosi, - carbamazepine, użat għal epilessija, - medicini barbiturati bħal phenobarbital, użat għal epilessija u disturbi fl-irqad, - phenytoin, użat għal epilessija, - St John's wort, mediċina minn ħxejjex użata għal depressjoni. - efavirenz, etravirine, użati f'HIV, - nafcillin, użat għal infezzjoni batterika.
English: See the end of section 4 for how to report side effects.
Maltese: Ara t-tmiem ta' sezzjoni 4 biex tara kif għandek tirraporta effetti sekondarji.
English: Other sources of information
Maltese: Parametru Statistiku
English: (CYP3A4 inhibition)
Maltese: (impediment ta' CYP3A4)
English: Isavuconazole may increase the exposure of medicinal products that are P-gp substrates.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: The concomitant administration of CRESEMBA and high doses of ritonavir (>200 mg every 12 hours) is contraindicated.
Maltese: L-għoti fl-istess waqt ta' CRESEMBA u dożi għoljin ta' ritonavir (>200 mg kull 12-il siegħa) hu kontraindikat.
English: Isavuconazole can be considered a moderate inhibitor of CYP3A4/5, and systemic exposure to medicinal products metabolised by CYP3A4 may be increased when co-administered with CRESEMBA.
Maltese: Isavuconazole għandu jiġi kkunsidrat bħala impeditur moderat ta' CYP3A4/5 u l-esponiment sistemiku għal prodotti mediċinali metabolizzati minn CYP3A4 jista' jiżdied meta jingħata ma' CRESEMBA..
English: The safety and efficacy of isavuconazole for the treatment of patients with invasive aspergillosis was evaluated in a double-blind, active-controlled clinical study in 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi.
Maltese: Is-sigurtà u l-effikaċja ta' isavuconazole għat-trattament ta' pazjenti b'asperġillosi invażiva ġew evalwati fi studju kliniku, double-blind u b'kontrolli-attivi fuq 516-il pazjent b'mard fungali invażiv ikkaġunat minn speċi ta' Asperġillus jew moffa filamentiża oħra.
English: Do not take Cresemba: - if you are allergic to isavuconazole or any of the other ingredients of this medicine (listed in section 6), - if you have a heart beat problem called ‘familial short QT syndrome', - if you are using any of the following medicines: - ketoconazole, used for fungal infections, - high doses of ritonavir (400 mg every 12 hours), used for HIV, - rifampicin, rifabutin, used for tuberculosis, - carbamazepine, used for epilepsy, - barbiturate medicines like phenobarbital, used for epilepsy and sleep disorders,
Maltese: Tiħux Cresemba: - jekk inti allerġiku għal isavuconazole jew għal xi sustanza oħra ta' din il-mediċina (elenkati fissezzjoni 6), - jekk għandek problema bit-taħbit tal-qalb tiegħek li tissejjaħ ‘sindromu familjali ta' QT qasir', - jekk qed tuża xi wieħed mill-mediċini li ġejjin: - ketoconazole, użat għal infezzjonijiet fungali, - dożi għoljin ta' ritonavir (400 mg kull 12-il siegħa), użat għal HIV, - rifampicin, rifabutin, użat għal tuberkulosi, - carbamazepine, użat għal epilessija, - medicini barbiturati bħal phenobarbital, użat għal epilessija u disturbi fl-irqad, - phenytoin, użat għal epilessija,
English: Each vial contains 372.6 mg isavuconazonium sulfate,
Maltese: Kull kunjett fih 372.6 mg isavuconazole sulfate, li jikkorispondi għal 200 mg isavucanazole.
English: Medicinal products that inhibit CYP3A4/5
Maltese: Prodotti mediċinali li jinduċu CYP3A4/5
English: Isavuconazole is a mild inhibitor of UGT.
Maltese: Isavuconazole huwa impeditur ħafif ta' UGT.
English: As shown in table 4 below, the absolute bioavailability of isavuconazole following oral administration of a single dose of CRESEMBA is 98%.
Maltese: Kif muri f'tabella 4 isfel, il-bijodisponibilità assoluta ta' isovuconazole wara l-għoti orali ta' doża waħda ta' CRESEMBA hi 98%.
English: Following oral administration of CRESEMBA in healthy subjects, the active moiety isavuconazole is absorbed and reaches maximum plasma concentrations (Cmax) approximately 2-3 hours after single and multiple dosing (see Table 3).
Maltese: Wara l-għoti orali ta' CRESEMBA f'individwi b'saħħithom, il-porzjon attiv ta' isavuconazole jiġi assorbit u jilħaq konċentrazzjoni massima fil-plażma (Cmax) madwar 2-3 sigħat wara doża waħda u multipla (ara tabella 3).
English: Co-administration of CRESEMBA with medicinal products which are substrates of UGT may result in mildly increased plasma concentrations of these medicinal products.
Maltese: L-għoti ta' CRESEMBA flimkien ma' prodotti mediċinali li huma sottostrati ta' UGT jista' jirriżulta f'konċentrazzjonijiet ftit ogħla ta' dawn ilprodotti mediċinali fil-plażma.
English: Co-administered medicinal product by therapeutic area
Maltese: TAL-PRODOTT MEDIĊINALI
English: The concomitant administration of CRESEMBA and rifampicin is contraindicated.
Maltese: Statins oħrajn ma ġewx studjati.
English: 7-hydroxymetabolite: AUCinf: ↑ 29% Cmax: ↑ 15%
Maltese: AUCinf: ↑ 29% Cmax: ↑ 15%
English: Common: may affect up to 1 in 10 people - low potassium in your blood, - decreased appetite, - hallucinations (delirium), - headache, - sleepiness, - inflamed veins that could lead to blood clots, - shortness of breath or sudden and severe difficulty breathing, - feeling sick (nausea), being sick (vomiting), diarrhoea, stomach pain, - changes in blood tests of liver function, - rash, itching, - kidney failure, - chest pain, feeling tired or sleepy, - problems where the injection was given.
Maltese: Komuni: jistgħu jaffettwaw sa persuna 1 f'10 - livell ta' potassju baxx fid-demm tiegħek, - tnaqqis fl-aptit, - alluċinazzjonijiet (delirju), - uġigħ ta' ras, - ngħas, - vini infjammati li jistgħu jwasslu għal emboli tad-demm, - nuqqas ta' nifs jew diffikultà biex tieħu n-nifs f'daqqa u b'mod sever, - tħossok ma tiflaħx (dardir), tħossok marid (remettar), dijarea, uġigħ fl-istonku, - bidliet fit-testijiet tad-demm tal-funzjoni tal-fwied, - raxx, ħakk, - falliment tal-kliewi, - uġigħ fis-sider, tħossok għajjien jew mħeddel, - problemi fejn ingħatat l-injezzjoni.
English: The vial will be given as a drip into a vein by your doctor or nurse.
Maltese: Cresemba ser jingħata lilek minn tabib jew infermier/a.
English: Therefore, caution is advised when CYP2B6 substrates, especially medicinal products with a narrow therapeutic index such as cyclophosphamide, are co-administered with CRESEMBA.
Maltese: Għalhekk, hija rrakkomandata l-kawtela meta sottostrati ta' CYP2B6, speċjalment prodotti mediċinali b'indiċi terapewtiku dejjaq, bħal cyclophosphamide, jingħataw flimkien ma' CRESEMBA.
English: Severe heart failure (NYHA Class IV)
Maltese: Insuffiċjenza tal-qalb severa (Klassi
English: Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred.
Maltese: Xi studji farmakodinamiċi juru li meta dożi waħdiena ta' ibuprofen 400 mg ttieħdu fi żmien 8 sigħat qabel jew fi żmien 30 minuta wara d-dożaġġ ta' acetylsalicylic acid li jerħi b'mod immedjat (81 mg), kien hemm tnaqqis fl-effett ta' acetylsalicylic acid fuq il-formazzjoni ta' thromboxane jew l-aggregazzjoni talplejtlits.
English: For all ibuprofen-containing products
Maltese: Għall-prodotti kollha li fihom ibuprofen
English: No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
Maltese: L-ebda effett klinikament rilevanti mhuwa kkunsidrat probabbli għall-użu okkażjonali ta' ibuprofen (ara sezzjoni 5.1).
English: Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.
Maltese: Filwaqt li m'hemm ebda dejta disponibbli għal dexibuprofen, huwa raġonevoli li wieħed jassumi li tista' teżisti interazzjoni simili bejn dexibuprofen (= S(+)-ibuprofen) (li huwa l-enantiomer farmakoloġikament attiv ta' ibuprofen) u acetylsalicylic acid f'doża baxxa.
English: No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).
Maltese: L-ebda effett klinikament rilevanti mhuwa kkunsidrat probabbli għall-użu okkażjonali ta' ibuprofen (ara sezzjoni 4.5).
English: Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly.
Maltese: Id-dejta sperimentali tissuġġerixxi li ibuprofen jista' kompettivament jinibixxi l-effett ta' acetylsalicylic acid f'doża baxxa fuq l-aggregazzjoni tal-plejtlits meta jkunu ddożati flimkien.
English: - medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Maltese: - mediċini li huma antikoagulanti (jiġifieri iraqqu d-demm /jipprevjenu t-tagħqid eż. aspirina/acetylsalicylic acid, warfarin, ticlopidine) - mediċini li jbaxxu pressjoni għolja tad-demm (inibituri ACE bħal captopril, imblokkaturi beta bħal mediċini li fihom atenolol, antagonisti tar-riċetturi ta' angiotensin-II bħal losartan)
English: Although there are limited data on the arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high dose dexibuprofen (1200 mg/day) would be similar to that associated with high dose ibuprofen (2400 mg/day).
Maltese: Għalkemm teżisti dejta limitata dwar r-riskju trombotiku arterjali ta' dexibuprofen, huwa raġonevoli li wieħed jassumi li r-riskju b'dexibuprofen f'doża għolja (1200 mg/kuljum) ikun simili għal dak assoċjat ma' ibuprofen f'doża għolja (2400 mg/kuljum).
English: Section 4.8 - Undesirable effects [The section should be amended to reflect the following wording]
Maltese: Sezzjoni 4.8 - Effetti mhux mixtieqa [Is-sezzjoni għandha tiġi emendata biex tirrifletti l-formulazzjoni li ġejja]
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction [The section should be amended to reflect the following wording]
Maltese: Sezzjoni 4.5 - Interazzjonijiet ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni [Is-sezzjoni għandha tiġi emendata biex tirrifletti l-formulazzjoni li ġejja]
English: For example:
Maltese: A.
English: Section 5.1 - Pharmacodynamic properties [The section should be amended to reflect the following wording]
Maltese: Sezzjoni 5.1 - Proprjetajiet farmakodinamiċi [Is-sezzjoni għandha tiġi emendata biex tirrifletti l-formulazzjoni li ġejja]
English: - have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Maltese: - ikollok pressjoni tad-demm għolja, dijabete, kolesterol għoli, storja fil-familja ta' mard tal-qalb jew puplesija, jew jekk tpejjep.
English: Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Maltese: L-istudji kliniċi jissuġġerixxu li l-użu ta' ibuprofen, b'mod partikolari f'doża għolja (2400 mg/kuljum) jista' jkun assoċjat ma' żieda żgħira fir-riskju ta' episodji trombotiċi arterjali (pereżempju infart mijokardijaku jew puplesija) (ara sezzjoni 4.4).
English: Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with dexibuprofen after careful consideration and high doses (1200 mg/day) should be avoided.
Maltese: Il-pazjenti bi pressjoni għolja mhux ikkontrollata, insuffiċjenza tal-qalb konġestiva (NYHA II-III), mard tal-qalb iskemiku stabbilit, mard arterjali periferali, u/jew mard ċerebrovaskulari għandhom jiġu kkurati biss b'dexibuprofen wara kunsiderazzjoni xierqa u dożi għoljin (1200 mg/kuljum) għandhom jiġu evitati.
English: - have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke' or transient ischaemic attack “TIA”).
Maltese: - ikollok problemi tal-qalb inkluż insuffiċjenza tal-qalb, anġina (uġigħ fis-sider), jew jekk kellek attakk tal-qalb, kirurġija tal-bypass, mard tal-arterji periferali (ċirkolazzjoni batuta fir-riġlejn tas-saqajn minħabba arterji dojoq jew imblokkati), jew kwalunkwe tip ta' puplesija (inkluż puplesija "żgħira" jew attakk iskemiku temporanju "TIA").
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction [The section should be amended to reflect the following wording (if sub-sections exist this wording should be included in the relevant sub-section, e.g. concomitant use not recommended)]
Maltese: Sezzjoni 4.5 - Interazzjonijiet ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni [Is-sezzjoni għandha tiġi emendata biex tirrifletti l-formulazzjoni li ġejja (jekk ikunu jeżistu sottosezzjonijiet, din il-formulazzjoni għandha tiġi inkluża fis-sottosezzjoni rilevanti, eż. l-użu konkomitanti mhuwiex rakkomandat)]
English: Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
Maltese: Kunsiderazzjoni xierqa għandha wkoll tiġi eżerċitata qabel tinbeda l-kura fit-tul ta' pazjenti b'fatturi ta' riskju għal avvenimenti kardjovaskulari (eż. pressjoni għolja, iperlipidemija, dijabete mellitus, tipjip), b'mod partikolari jekk dożi għoljin ta' ibuprofen (2400 mg/kuljum) ikunu meħtieġa.
English: Section 4.3 - Contraindications [The section should be amended to reflect the following wording]
Maltese: Sezzjoni 4.3 - Kontraindikazzjonijiet [Is-sezzjoni għandha tiġi emendata biex tirrifletti l-formulazzjoni li ġejja]
English: Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of dexibuprofen (1200 mg/day) are required.
Maltese: Kunsiderazzjoni xierqa għandha wkoll tiġi eżerċitata qabel tinbeda l-kura fit-tul ta' pazjenti b'fatturi ta' riskju għal avvenimenti kardjovaskulari (eż. pressjoni għolja, iperlipidemija, dijabete mellitus, tipjip), b'mod partikolari jekk dożi għoljin ta' dexibuprofen (1200 mg/kuljum) ikunu meħtieġa.
English: Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Maltese: Il-pazjenti bi pressjoni għolja mhux ikkontrollata, insuffiċjenza tal-qalb konġestiva (NYHA II-III), mard tal-qalb iskemiku stabbilit, mard arterjali periferali, u/jew mard ċerebrovaskulari għandhom jiġu kkurati biss b'ibuprofen wara kunsiderazzjoni xierqa u dożi għoljin (2400 mg/kuljum) għandhom jiġu evitati.
English: Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Maltese: L-istudji kliniċi jissuġġerixxu li l-użu ta' ibuprofen, b'mod partikolari f'doża għolja (2400 mg/kuljum) jista' jkun assoċjat ma' żieda żgħira fir-riskju ta' episodji trombotiċi arterjali (pereżempju infart mijokardijaku jew puplesija).