FrancophonIA/ELRC3.0 huggingface dataset:
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Ibandronic acid Sandoz administration.
Maltese: Waqt it-trattament, proċeduri dentali invażivi għandhom isiru biss wara konsiderazzjoni b'attenzjoni u għandhom jiġu evitati qrib ta' għoti ta' Ibandronic acid Sandoz.
English: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Ibandronic acid Sandoz tablets.
Maltese: Prodotti li fihom l-kalċju u ketajins mutivalenti (bħal aluminju, manjesju, ħadid) oħra, inkluż il-ħalib u l-ikel, x'aktarx jinterferixxu fl-assorbiment tal-pilloli Ibandronic acid Sandoz.
English: Uncommon (may affect less than 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw inqas minn persuna 1 minn kull 100):
English: Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronic acid System Organ
Maltese: Tabella 1 Reazzjonijiet Avversi għall-Mediċina Rrappurtati għall-Għoti Orali ta' Ibandronic acid
English: Hepatic impairment (see section 4.2)
Maltese: Indeboliment tal-fwied (ara sezzjoni 4.2)
English: They include a decreased number of implantation sites, interference with natural delivery (dystocia), an increase in visceral variations (renal pelvis ureter syndrome) and teeth abnormalities in F1 offspring in rats.
Maltese: Dawn jinkludu numru iżgħar ta' siti ta' implantazzjoni, interferenza fil-ħlas naturali (distoċja), żjieda fil-varjazzjonijiet fil-vixxri (sindrome tal-uretru pelviku renali) u anomaliji fis-snien fil-frieħ F1 fil-firien.
English: In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0.3 and 1 mg/kg/day and decreased fertility in males at 1 mg/kg/day and in females at 1.2 mg/kg/day.
Maltese: Fi studji dwar l-effett fuq issistema riproduttiva fuq il-firien b'għoti fil-vina, ibandronic acid naqqas l-għadd tal-isperma b'dożi ta' 0.3 u 1 mg/kg/kuljum u naqqas il-fertilità fl-irġiel b'1 mg/kg/kuljum u fin-nisa b'1.2 mg/kg/kuljum.
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Maltese: Ladarba Acetylsalicylic acid, prodotti mediċinali Anti-Infjammatorji Nonsterojdali (NSAIDs) u bisphosphonates huma assoċjati ma' irritazzjoni gastro-intestinali, wieħed irid joqgħod attent meta jieħu dawn il-mediċini fl-istess ħin.
English: The safety and efficacy of ibandronic acid in children and adolescents below the age of 18 years have not been established.
Maltese: .2) Is-sigurtà u l-effikaċja ta' ibandronic acid fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg ibandronic acid (287 patients).
Maltese: Pazjenti femminili b'kanċer tas-sider u metastasi flgħadam ikkonfermat radjoloġikament kienu magħżula b'mod każwali biex jirċievu plaċebo (277 pazjent) jew Ibandronic acid Sandoz 50 mg (287 pazjent).
English: Pooled data from these studies demonstrated a significant advantage for ibandronic acid 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Maltese: Dejta miġbura minn dawn l-istudji wriet vantaġġ sinifikanti għal Ibandronic acid Sandoz 50 mg p.o. fuq il-plaċebo biex inaqqas SREs imkejla b'SMPR (p=0.041).
English: Not known (frequency cannot be estimated from the available data) • asthma attack
Maltese: Mhux magħruf (frekwenza ma tistax tiġi stmata mid-data disponibbli)
English: This belongs to a group of medicines called bisphosphonates.
Maltese: Din tagħmel parti minn grupp ta' mediċini msejħin bisfosfonati.
English: - radiotherapy to bone for treatment of fractures/impending fractures - surgery to bone for treatment of fractures - vertebral fractures - non-vertebral fractures
Maltese: - radjuterapija fl-għadam għat-trattament ta' fratturi/fratturi imminenti - kirurġija fl-għadam għat-trattament ta' fratturi - fratturi fil-vertebra - fratturi mhux fil-vertebra
English: Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy.
Maltese: Studji kliniċi ma wrew l-ebda evidenza ta' deterjorament fil-funzjoni tal-kliewi b'terapija fit-tul b'ibandronic acid.
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic acid Sandoz is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).
Maltese: Minħabba l-possibbiltà ta' dawn l-effetti irritanti u l-potenzjal għal deterjorament tal-marda prinċipali, għandu jkun hemm attenzjoni meta Ibandronic acid Sandoz jingħata lill-pazjenti bi problemi attivi tal-apparat gastro-intestinali ta' fuq (eż. esofagu ta' Barrett, disfaġja, mard ieħor talesofagu, gastrite, duwodenite jew ulċeri magħrufa).
English: Take Ibandronic acid Sandoz at least 6 hours after you last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water.
Maltese: Ħu Ibandronic acid Sandoz għallinqas 6 sigħat wara li tkun ħadt xi ħaġa x'tiekol, x'tixrob jew xi mediċina jew supplement ieħor (eż. prodotti li fihom il-kalċju (ħalib), aluminju, magneżju u ħadid) għajr ilma.
English: What Ibandronic acid Sandoz looks like and contents of the pack The film-coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC - Aluminum foil blister.
Maltese: Il-pilloli miksija b'rita huma pilloli bojod, tondi, ibbuzzati fuq iż-żewġ naħat disponibbli f'folja ta' Polyamide/Al/PVC - fojl tal-Aluminju.
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronic acid Sandoz.
Maltese: Jekk qed tirċievi trattament dentali jew ser tagħmel kirurġija dentali (eż. qlugħ ta' snien), għarraf littabib tiegħek dwar it-trattament dentali tiegħek u għid lid-dentist tiegħek li qed tiġi ttrattat b'Ibandronic acid Sandoz.
English: Renal impairment No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Maltese: Mhux meħtieġ aġġustament fid-doża għall-pazjenti b'indeboliment ħafif tal-kliewi (CLcr ≥50 u <80 mL/min).
English: The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Maltese: Il-mira primarja tal-prova kienet ir-rata tal-perijodu tal-morbidità skeletrika (SMPR).
English: Paraesthesia, dysgeusia (taste perversion)
Maltese: Parestesija, indeboliment fis-sens tattogħma (tibdil fittogħma)
English: Chest pain, influenza-like illness, malaise, pain
Maltese: Uġigħ fissider, mard qisu influwenza, telqa, uġigħ
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Ibandronic acid Sandoz in patients with concomitant risk factors.
Maltese: Eżami dentali b'dentistrija preventiva u stima tal-benefiċċju u r-riskju individwali huma rakkomandati qabel trattament b'Ibandronic acid Sandoz f'pazjenti li għandhom fatturi ta' riskju fl-istess waqt.
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, Bisphosphonates, ATC Code: M05BA06.
Maltese: Prodotti mediċinali għal trattament ta' mard tal-għadam, Bisfosfonat, Kodiċi ATC:
English: Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Maltese: Il-bijodisponibilità hija mnaqqsa b'madwar 90% meta ibandronic acid jingħata ma' kolazzjon normali meta mqabbla malbijodisponibilità f'pazjenti sajmin.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50 mg film-coated tablet every second day is recommended (see section 5.2).
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥30 u <50 mL/min) huwa rrakkomandat aġġustament fid-dożaġġ għall-pillola waħda miksija b'rita ta' 50 mg kull jumejn (ara sezzjoni 5.2).
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Ibandronic acid Sandoz tablets.
Maltese: Prodotti mediċinali u supplimenti (li jinkludu l-calcium) għandhom ukoll jiġu evitati qabel ma jittieħdu l-pilloli Ibandronic acid Sandoz.
English: In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity.
Maltese: Antagonisti tal-H2 jew prodotti mediċinali oħrajn li jżidu l-pH gastriku F'voluntiera rġiel b'saħħithom u nisa li għaddew mill-menopawża, ranitidine fil-vini kkawża żjieda fil-bijodisponibilità ta' ibandronic acid ta' bejn wieħed u ieħor 20% (li hi fil-varjabbilità normali talbijodisponibilità ta' ibandronic acid), probabilment bħala riżultat ta' tnaqqis tal-aċidità gastrika.
English: How to take Ibandronic acid Sandoz
Maltese: Tiħux Ibandronic acid Sandoz
English: The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Maltese: Il-firxa osservata ta' half-lifes apparenti hija wiesgħa u tiddependi fuq id-doża u s-sensittività talanalażi, iżda l-half-life terminali apparenti ġeneralment hija fil-firxa ta' 10-60 siegħa.
English: As renal function decreases with age, this is the only factor to take into consideration (see renal impairment section).
Maltese: Hekk kif il-funzjoni renali tonqos bl-eta', dan huwa l-uniku fattur li għandu jiġi kkunsidrat (ara s-sezzjoni dwar indeboliment tal-kliewi).
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for oncology indications (see section 4.8).
Maltese: Osteonekrosi tax-xedaq (ONJ - osteonecrosis of the jaw) kienet irrappurtata b'mod rari ħafna flambjent ta' wara t-tqegħid fis-suq f'pazjenti li jirċievu ibandronic acid għal indikazzjonijiet onkoloġiċi (ara sezzjoni 4.8).
English: Anaphylactic reaction/shock
Maltese: Reazzjoni anafilattika/xokk anafilattika
English: Urinary concentrations of the bone resorption marker CTx (Cterminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo.
Maltese: Konċentrazzjonijiet urinarji tal-markatur tal-assorbiment mill-ġdid tal-għadam CTx (C-terminaltelopeptide rilaxxata minn kollaġen Tip I) kienu mnaqqsa b'mod sinifikattiv fil-grupp ta' ibandronic acid meta mqabbla mal-plaċebo.
English: Do not take Ibandronic acid Sandoz:
Maltese: X'fih Ibandronic acid Sandoz:
English: Other medicines and Ibandronic acid Sandoz
Maltese: Mediċini oħra u Ibandronic acid Sandoz
English: After taking your tablet, wait at least 30 minutes.
Maltese: Wara li tieħu l-pillola tiegħek, stenna għallinqas 30 minuta.
English: Studies in rats have shown reproductive toxicity (see section 5.3).
Maltese: Anzjani Mhux meħtieġ aġġustament fid-doża (ara sezzjoni 5.2).
English: • you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
Maltese: • irċevejt trattament qabel b'bisphosphonate (użat għat-trattament jew prevenzjoni ta' disturbi fl għadam)
English: Patients should pay particular attention and be able to comply with the dosing instructions (see section 4.2).
Maltese: Il-pazjenti għandhom jagħtu attenzjoni partikolari u jkunu kapaċi jikkonformaw malistruzzjonijiet tad-dożaġġ (ara sezzjoni 4.2).
English: Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Maltese: Ibandronic acid huwa eliminat permezz ta' eskrezzjoni renali biss u ma jgħaddi minn ebda biotrasformazzjoni.
English: Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women.
Maltese: Sess Il-bijodisponibiltà u l-farmakokinetika ta' ibandronic acid huma simili fl-irġiel u fin-nisa.
English: SK-821 04 Bratislava Tel: +421 2 48 200 600
Maltese: SK-821 04 Bratislava
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration.
Maltese: L-assorbiment ta' ibandronic acid fl-apparat gastro-intestinali ta' fuq huwa mgħaġġel wara għoti orali.
English: Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic acid Sandoz.
Maltese: Li tieħu mediċini li jnaqqsu l-aċidu fl-istonku bħal cimetidine u ranitidine, jista' jżid xi ftit l-effetti ta' Ibandronic acid Sandoz.
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic acid Sandoz therapy.
Maltese: Pazjenti b'disturbi ta' metaboliżmu fl-għadam u minerali Ipokalċemija u disturbi oħra fil-metaboliżmu tal-għadam u l-minerali għandhom jiġu kkurati b'mod effettiv qabel ma tinbeda terapija b'Ibandronic acid Sandoz.
English: Children and adolescents Ibandronic acid Sandoz should not be used in children and adolescents below the age of 18 years.
Maltese: Tfal u adolexxenti Ibandronic acid Sandoz m'għandux jintuża fi tfal u adolexxenti b'età inqas minn 18-il sena.
English: Further, as protein binding of ibandronic acid is approximately 87% at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration.
Maltese: Barra dan, peress li l-għaqda ta' ibandronic acid mal-proteini hija madwar 87% f'konċentrazzjonijiet terapewtiċi, ipoprotenemija f'mard sever talfwied x'aktarx ma twassalx għal żidiet ta' sinifikanza klinika fil-konċentrazzjoni ħielsa fil-plażma.
English: Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Ibandronic acid Sandoz in patients less than 18 years old.
Maltese: Popolazzjoni pedjatrika (ara sezzjoni 4.2 u sezzjoni 5.1) M'hemm l-ebda tagħrif dwar l-użu ta' Bondronat f'pazjenti b'eta' inqas minn 18-il sena.
English: Table 3 Secondary Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Maltese: Tabella 3 Riżultati sekondarji tal-effikaċja (pazjenti b'kanċer tas-sider b'mard metastatiku tal-Għadam)
English: Exposure to ibandronic acid in patients with various degree of renal impairment is related to creatinine clearance (CLcr).
Maltese: Espożizzjoni għal ibandronic acid f'pazjenti bi gradi varji ta' indeboliment tal-kliewi hija relatata b'mod lineari mat-tneħħija tal-kreatinina (CLcr).
English: • if you cannot stand or sit upright for at least one hour (60 minutes) at a time
Maltese: • jekk ma tkunx tista' toqgħoq bilwiefqa jew bilqiegħda wieqaf għal tal-inqas siegħa (60 minuta)
English: This is because NSAIDs and Ibandronic acid Sandoz can both irritate your stomach and gut a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Maltese: • tip ta' injezzjoni antibijotika msejħa “aminoglycoside” bħal gentamicin.
English: A statistically significant improvement in bone pain score was shown for ibandronic acid 50 mg compared to placebo.
Maltese: Titjib għall-aħjar fil-punteġġ ta' uġigħ fl-għadam statistikament sinifikanti intwera għal ibandronic acid 50 mg meta mqabbel mal-plaċebo.
English: The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Maltese: L-inibizzjoni ta' assorbiment endoġenu tal-għadam kien dokumentat ukoll permezz ta' studji kinetiċi b'45Ca u l-liberazzjoni ta'
English: The secretory pathway of renal elimination does not appear to include known acidic or basic transport systems involved in the excretion of other active substances In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Maltese: Barra minn hekk, ibandronic acid ma jinibixxix l-isoenzimi P450 epatiċi umani maġġuri u ma jinduċux is-sistema P450 ta' cytochrome talfwied fil-firien.
English: While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Maltese: Waqt it-trattament, għandek iżżomm iġjene orali tajba (inkluż ħasil regolari tas-snien) u tirċievi eżaminazzjonijiet dentali b'mod regolari.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Polyamide/Al/PVC - Aluminium foil blister
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI Polyamide/Al/PVC - Folja tal-fojl tal-aluminju
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Maltese: Ksur atipiku subtrokanteriku u diaphyseal fil-qasba tas-sieq ġie rrappurtat b'terapija bi bisphosphonate, primarjament f'pazjenti li kienu qed jirċievu trattament fit-tul għal osteoporożi.
English: Manufacturer
Maltese: Sistema
English: While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications.
Maltese: Filwaqt li ma kienet osservata l-ebda żjieda fir-riskju fi provi kliniċi kkontrollati kien hemm rapporti ta' wara t-tqegħid fis-suq ta' ulċeri gastriċi u duwodenali bl-użu ta' bisphosphonates orali, uħud severi u b'kumplikazzjonijiet.
English: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Maltese: It-tneħħija mill-kliewi (madwar 60 mL/min f'nisa f'saħħithom li għaddew mill-menopawża) hija responsabbli għal 50-60% tat-tneħħija totali u hija relatata mat-tneħħija tal-krejatinina.
English: Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Maltese: Fi studji li mhumiex kliniċi, l-effetti dehru biss wara esponimenti ferm aktar għolja mill-massimu ta' esponiment fil-bniedem, li juru ftit li xejn rilevanza għall-użu kliniku.
English: You may have early signs of a possible unusual fracture of the thigh bone.
Maltese: Jista' jkollok sinjali bikrin ta' ksur mhux normali possibbli tal-għadam tal-koxxa.
English: • Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).
Maltese: • Għandek tibqa' f'pożizzjoni dritta (bilqiegħda jew bilwieqfa) waqt li qed tieħu l-pillola tiegħek (60 minuta).
English: The difference between the apparent total and renal clearances is considered to reflect the uptake by bone.
Maltese: Id-differenza bejn it-tneħħija apparenti totali u dik mill-kliewi hija kkunsidrata li tirrifletti l-assorbiment mill-għadam.
English: White round biconvex tablets
Maltese: Taħrix talażżma
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for cancer-related conditions.
Maltese: Effett sekondarju msejjaħ osteonekrosi tax-xedaq (ONJ - osteonecrosis of the jaw) (ħsara fl-għadam fix-xedaq) kien irrappurtat b'mod rari ħafna fl-ambjent ta' wara t-tqegħid fis-suq f'pazjenti li kienu qed jirċievu ibandronic acid għall-kondizzjonijiet relatati mal-kanċer.
English: The active substance is aripiprazole.
Maltese: Is-sustanza attiva hi aripiprazole.
English: • loss of appetite (anorexia),
Maltese: • nuqqas t'aptit (anoressija),
English: 14 tablets 28 tablets 49 tablets 56 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 49 pillola 56 pillola 98 pillola
English: Increased Alanine Aminotransferase (ALT)
Maltese: Żieda fl-alanine aminotransferase (ALT)
English: The absolute oral bioavailability of the tablet formulation is 87%.
Maltese: Ilbijodisponibbilità orali assoluta tal-formolazzjoni tal-pillola hija ta' 87 %.
English: The following adverse reactions had a possible dose response relationship; extrapyramidal disorder (incidences were 10 mg, 9.1%, 30 mg, 28.8%, placebo, 1.7%,); and akathisia (incidences were 10 mg, 12.1%, 30 mg, 20.3%, placebo, 1.7%).
Maltese: Dawn ir-reazzjonijiet avversi kellhom relazzjoni possibbli mar-rispons tad-doża; disturb ekstrapiramidali (l-inċidenzi kienu 10 mg, 9.1 %, 30 mg, 28.8 %, plaċebo, 1.7 %); u akatisija (linċidenzi kienu 10 mg, 12.1 %, 30 mg, 20.3 %, plaċebo, 1.7 %).
English: Consequently, the frequency of these adverse events is qualified as “not known”.
Maltese: Għaldaqstant, il-frekwenza ta' dawn il-każijiet avversi hi kkwalifikata bħala “mhux magħruf”.
English: OPA/Alu/PVC/Alu foil blisters (Alu-Alu blister), carton box.
Maltese: Folji tal-fojl OPA/Alu/PVC/Alu (folja tal-Alu-Alu), kaxxa tal-kartun.
English: • Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
Maltese: • antikonvulsanti użati biex jittrattaw l-epilessija (bħal carbamazepine, phenytoin, phenobarbital)
English: See leaflet for further information.
Maltese: Ara l-fuljett għal iktar informazzjoni.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 ta' Ġunju 2015
English: The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32% and 47%, respectively.
Maltese: L-AUC u Cmax ta' dehydro-aripiprazole, is-sustanza metabolika attiva, tnaqqsu bejn 32 % u 47 % rispettivament.
English: Pack size: 14, 28, 49, 56, or 98 tablets
Maltese: Daqs tal-pakkett: 14, 28, 49, 56, jew 98 pillola
English: • Antifungal medicines (such as ketoconazole, itraconazole)
Maltese: • mediċini ta' kontra l-moffa (bħal ketoconazole, itraconazole)
English: Schizophrenia
Maltese: Skizofrenja
English: The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 0.242 - 0.879) in the full population.
Maltese: Il-punt ta' stima tal-proporzjon ta' periklu (HR - hazard ratio) kien globalment (individwi kollha) 0.461 (95 % tal-intervall ta' kunfidenza, 0.242-0.879) fil-popolazzjoni sħiħa.
English: In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56 - 99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo.
Maltese: Fi tliet provi kkontrollati minn plaċebo (n = 938; età medja: 82.4 snin; medda: 56-99 sena) ta' aripiprazole f'pazjenti anzjani bi psikosi assoċjata mal-marda Alzheimer, pazjenti kkurati b'aripirazole kellhom riskju ogħla ta' mewt imqabbla mal-plaċebo.
English: • Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
Maltese: • ċerti antibijotiċi użati biex jittrattaw it-tuberkolosi (rifabutin, rifampicin)
English: Aripiprazole Zentiva contains sodium
Maltese: Aripiprazole Zentiva fiha sodium
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Maltese: Każijiet ta' tromboemboliżmu fil-vini (VTE - venous thromboembolism) kienu rrappurtati bi prodotti mediċinali antipsikotiċi.
English: The AUC and Cmax of dehydro-aripiprazole increased by 77% and 43%, respectively.
Maltese: L-AUC u Cmax ta' dehydro-aripiprazole żdiedu b' 77 % u 43 % rispettivament.
English: In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78 - 88 years).
Maltese: Fl-istess provi, kienu rrappurtati reazzjonijiet avversi ċerebrovaskulari (eż. puplesija, attakk għaddieni iskemiku), inklużi uħud fatali, f'pazjenti (età medja: 84 sena; medda: 78-88 sena).