FrancophonIA/ELRC3.0 huggingface dataset:
English: Nobilis IB 4-91 can be given to 1-day-old chicks and older chickens by coarse spray or by intranasal (breathed in through the nose) or ocular (absorbed by the eyes) administration.
Maltese: Nobilis IB 4-91 jista' jingħata lil flieles ta' jum wieħed u tiġieġ akbar bi sprej rozz jew intranasali (jittieħed man-nifs mill-imnieħer) jew okulari (assorbit mill-għajnejn).
English: Other information about Nobilis IB 4-91:
Maltese: Tagħrif ieħor dwar Nobilis IB 4-91:
English: Why has Nobilis IB 4-91 been approved?
Maltese: Għaliex ġie approvat Nobilis IB 4-91?
English: Nobilis IB 4-91 vaccine has also been compared with controls, i.e. chickens that were not vaccinated.
Maltese: Il-vaċċin Nobilis IB 4-91 tqabbel ukoll mal-kontrolli, jiġifieri tiġieġ li ma ġewx imlaqqma.
English: When Nobilis IB 4-91 is given to chickens the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Maltese: Meta Nobilis IB 4-91 jingħata lit-tiġieġ, is-sistema immunitarja tal-annimali tagħraf lill-virus bħala “barrani” u tipproduċi antikorpi kontrih.
English: 1 bottle + 30 syringes + 1 syringe adapter + 1 carrying case
Maltese: 1 flixkun + 30 siringa + 1 adapter tas-siringa + 1 carrying case
English: What are the benefit and risk of Clopidogrel Qualimed?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Clopidogrel Qualimed?
English: Clopidogrel Qualimed clopidogrel
Maltese: Kif jintuża Clopidogrel Qualimed?
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Qualimed to Qualimed on 23 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Clopidogrel Qualimed lil QUalimed fit-23 ta' Settembru 2009.
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also
Maltese: Jekk tixtieq aktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CHMP, aqra dDiskussjoni Xjentifika (parti wkoll mill-EPAR).
English: This means that Clopidogrel Qualimed is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Clopidogrel Qualimed huwa ‘mediċina ġenerika' li jfisser li Clopidogrel Qualimed huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: The active substance in Clopidogrel Qualimed, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva ta' Clopidogrel Qualimed, clopidogrel, hu inibitur tal-aggregazzjoni tal-pjastrini.
English: Clopidogrel Qualimed is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Qualimed huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: Clopidogrel Qualimed is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel Qualimed jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).
English: The standard dose of Clopidogrel Qualimed is one 75 mg tablet once a day, taken with or without
Maltese: Huwa disponibbli bħala pilloli tondi roża (75 mg).
English: Because Clopidogrel Qualimed is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel Qualimed huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Qualimed has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel Qualimed wera li għandu kwalità komparabbli ma' u huwa bijoekwivalenti għal Plavix.
English: Because Clopidogrel Qualimed is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Clopidogrel Qualimed huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċju u r-riskju tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: Clopidogrel Qualimed can be given to the following groups of
Maltese: Clopidogrel Qualimed jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: How has Clopidogrel Qualimed been studied?
Maltese: X'inhu Clopidogrel Qualimed?
English: Why has Clopidogrel Qualimed been approved?
Maltese: Għaliex ġie approvat Clopidogrel Qualimed?
English: Clopidogrel Qualimed can be started between a few days and 35 days after the attack;
Maltese: Clopidogrel Qualimed jista' jinbeda fl-ewwel ftit jiem wara l-attakk u sa 35 ġurnata wara;
English: • rifampicin (against tuberculosis).
Maltese: • rifampicin (kontra t-tuberkolosi).
English: • macrolide antibiotics,
Maltese: • antibijotiċi makrolide,
English: Pollakiuria, Polyuria
Maltese: Pollakurja, Poliurja
English: conivaptan, fenoldopam mesylate or mirtazapine)
Maltese: conivaptan, fenoldopam mesylate jew mirtazapine)
English: Lactose and galactose intolerance
Maltese: Intolleranza għal lactose u galactose
English: 10 × 1 tablet 30 × 1 tablet
Maltese: 10 × 1 pillola 30 × 1 pillola
English: • if you suffer from a kidney disease called autosomal dominant polycystic kidney disease
Maltese: (ADPKD - autosomal dominant polycystic kidney disease)
English: Pharmacotherapeutic group: Diuretics, vasopressin antagonists, ATC code: C03XA01
Maltese: Dijuretiċi, antagonisti ta' vasopressini, Kodiċi ATC: C03XA01
English: Tolvaptan increased plasma levels of lovastatin by 1.3- to 1.5-fold.
Maltese: Tolvaptan żied il-livelli filplażma ta' lovastatin b'1.3 sa 1.5 darbiet.
English: • ketoconazole (against fungal infections),
Maltese: • ketoconazole (kontra infezzjonijiet tal-moffa),
English: • acute liver failure (ALF)
Maltese: • insuffiċjenza tal-fwied akuta (ALF - acute liver failure).
English: Consequently, the frequency of these adverse reactions is qualified as "not known".
Maltese: Għaldaqstant, il-frekwenza ta' dawn il-każijiet avversi hi kkwalifikata bħala “mhux magħruf”.
English: The absolute bioavailability of tolvaptan is about 56 %.
Maltese: Il-bijodisponibilità assoluta ta' tolvaptan hi ta' madwar 56 %.
English: 10 tablets 30 tablets 10 × 1 tablet 30 × 1 tablet
Maltese: 10 pilloli 30 pilloli 10 × 1 pillola 30 × 1 pillola
English: Elevation (>3 × ULN) of serum aspartate aminotransferase (AST) was observed in 3.1 % (30/958) of patients on tolvaptan and 0.8 % (4/484) patients on placebo.
Maltese: Żieda (> 3 × ULN) ta' aspartate aminotransferase (AST) fis-serum kienet osservata fi 3.1 % (30/958) talpazjenti fuq tolvaptan u f'0.8 % (4/484) tal-pazjenti fuq plaċebo.
English: Samsca is not suitable for children and adolescents (under age 18).
Maltese: Samsca mhux adattat għat-tfal u adolexxenti (taħt l-età ta' 18-il sena).
English: Blood urine present1, Alanine aminotransferase increased (see section 4.4)1, Aspartate aminotransferase increased (see section 4.4)1, Blood creatinine
Maltese: Demm fl-urina preżenti Żieda ta' alanine aminotransferase (ara sezzjoni 4.4)1, Żieda ta' aspartate aminotransferase (ara sezzjoni 4.4)1, Żieda tal-kreatinina fiddemm
English: AndersonBrecon (UK) Ltd. Units 2-7,
Maltese: AndersonBrecon (UK) Ltd.
English: Not known (cannot be estimated from the available data)
Maltese: Mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli)
English: The frequencies of the adverse reactions from clinical trials correspond with 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 (≥ 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: Elevated transaminases2
Maltese: Transaminases ogħla2
English: In 2 pivotal, double-blind, placebo-controlled, clinical trials, a total of 424 patients with euvolemic or hypervolemic hyponatremia (serum sodium < 135 mEq/L) due to a variety of underlying causes (heart failure [HF], liver cirrhosis, SIADH and others) were treated for 30 days with tolvaptan (n = 216) or placebo (n = 208) at an initial dose of 15 mg/day.
Maltese: Iponatrimija F'2 provi kliniċi importanti ħafna, li kienu double-blind, ikkontrollati bi plaċebo, total ta' 424 pazjent b'iponatrimija ewvolemika jew ipervolemika (sodium fis-serum < 135 mEq/L) dovuti għal kawżi differenti fl-isfond (insuffiċjenza kardijaka [HF], ċirrożi tal-fwied, SIADH u oħrajn) kienu ttrattati għal 30 jum b'tolvaptan (n = 216) jew plaċebo (n = 208) b'doża inizjali ta' 15 mg/jum.
English: For single doses 60 mg to 480 mg, a mean of about 7 litres was excreted during 0 to 12 hours, independent of dose.
Maltese: Għal dożi uniċi ta' 60 mg sa 480 mg, medja ta' madwar 7 litri ġew eliminati waqt 0 sa 12-il siegħa, indipendentement mid-doża.
English: Bilirubin increased (see section 4.4)1
Maltese: Żieda filbilirubina (ara sezzjoni 4.4)1
English: Less than 1 % of intact active substance is excreted unchanged in the urine.
Maltese: Anqas minn 1 % tas-sustanza attiva intatta tiġi eliminata mingħajr ma tinbidel fl-awrina.
English: • high levels of sodium, potassium, creatinine, uric acid and blood sugar
Maltese: • livelli għoljin ta' sodium, potassium, kreatinina, aċidu uriku u zokkor fid-demm
English: Samsca contains lactose
Maltese: Samsca fih lactose.
English: Single doses up to 480 mg and multiple doses up to 300 mg per day for 5 days have been well tolerated in clinical trials in healthy volunteers.
Maltese: Dożi waħidhom sa 480 mg u dożi multipli sa 300 mg kuljum għal 5 ijiem kienu tollerati tajjeb fi provi kliniċi f'voluntieri b'saħħithom.
English: Avoid drinking grapefruit juice when taking Samsca.
Maltese: Evita li tixrob meraq tal-grejpfrut meta tieħu Samsca.
English: Tolvaptan plasma concentrations have been decreased by up to 87 % (AUC) after the administration of CYP3A4 inducers.
Maltese: Il-konċentrazzjonijiet ta' tolvaptan fil-plażma naqsu b'87 % (AUC) wara l-għoti ta' induċaturi ta' CYP3A4.
English: Fluid and electrolyte balance
Maltese: Bilanċ tal-fluwidu u elettroliti
English: The results of self-assessed health status using the SF-12 Health Survey for the mental scores showed statistically significant and clinically relevant improvements for tolvaptan treatment compared to placebo.
Maltese: SF-12 għal punteġġi mentali wrew titjib statistikament sinifikanti u klinikament rilevanti għat-trattament b'tolvaptan meta mqabbel mal-plaċebo.
English: Tolvaptan has linear pharmacokinetics for doses of 7.5 to 60 mg.
Maltese: Tolvaptan għandu farmakokinetiċi lineari għal dożi ta' 7.5 sa 60 mg.
English: Date of first authorisation: 03 August 2009 Date of latest renewal: 19 June 2014
Maltese: Data tal-aħħar tiġdid:19 ta' Ġunju 2014
English: Block-7, City North Business Campus, Stamullen, Co.Meath, K32 YD60 Ireland
Maltese: Meath, K32 YD60
English: The adverse reaction profile of tolvaptan in SIADH is based on a clinical trials database of 3,294 tolvaptan-treated patients and is consistent with the pharmacology of the active substance.
Maltese: Il-profil ta' reazzjonijiet avversi ta' tolvaptan f'SIADH hu bbażat fuq dejtabejż ta' provi kliniċi li ttieħdu minn 3,294 pazjent ittrattat b'tolvaptan u hu konsistenti mal-farmakoloġija tas-sustanza attiva.
English: CYP3A4 substrates
Maltese: Impedituri CYP3A4
English: 50 mL/min) impaired renal function were not significantly different to tolvaptan concentrations in patients with normal renal function (Ccr 80 to 150 mL/min).
Maltese: (tneħħija ta' kreatinina [Ccr] ta' 50 sa 80 mL/min) jew moderat (Ccr 20 sa 50 mL/min) ma kinitx differenti b'mod sinifikanti minn konċentrazzjonijiet ta' tolvaptan f'pazjenti b'funzjoni renali normali (Ccr 80 sa 150 mL/min).
English: The pharmaco-dynamically predictable and most commonly reported adverse reactions are thirst, dry mouth and pollakiuria occurring in approximately 18 %, 9 % and 6 % of patients.
Maltese: Ir-reazzjonijiet avversi mbassra farmakodinamikament u rrappurtati bl-aktar mod komuni huma l għatx, ħalq xott u pollakurja li jseħħu f'madwar 18 %, 9 % u 6 % tal-pazjenti.
English: In order to minimise the risk of too rapid correction of hyponatremia the increase of serum sodium should be less than 10-12 mmol/L/24 hours and less than 18 mmol/L/48 hours.
Maltese: Sabiex wieħed inaqqas kemm jista' r-riskju ta' korrezzjoni mgħaġġla ħafna ta' iponatrimija, iż-żieda ta' sodium fis-serum għandu jkun inqas minn 10-12 mmol/L/24 siegħa u inqas minn 18 mmol/L/48 siegħa.
English: Too rapid correction of hyponatremia (increase ≥ 12 mmol/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma or death.
Maltese: Korrezzjoni mgħaġġla ħafna ta' iponatrimija (żieda ≥ 12 mmol/L/24 siegħa) tista' twassal għal demilinazzjoni osmotika li twassal għal disartrija, mutiżmu, disfaġja, għeja kbira, bidliet affettivi, kwadriparesi spastika, aċċessjonijiet, koma jew mewt.
English: Tolvaptan plasma concentrations have been increased by up to 5.4-fold area under time-concentration curve (AUC) after the administration of strong CYP3A4 inhibitors.
Maltese: Il-konċentrazzjonijiet ta' tolvaptan fil-plażma żdiedu sa 5.4 darbiet fl-erja ta' taħt il-kurva ħinkonċentrazzjoni (AUC) wara l-għoti ta' impedituri qawwija CYP3A4.
English: Samsca 7.5 mg tablets EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
Maltese: Samsca 7.5 mg pilloli EU/1/09/539/005 (10 pilloli) EU/1/09/539/006 (30 pilloli) EU/1/09/539/007 (10 × 1 pillola) EU/1/09/539/008 (30 × 1 pillola)
English: Very limited information is available in patients with severe hepatic impairment (Child-Pugh class C).
Maltese: Hemm informazzjoni ristretta ħafna f'pazjenti b'indeboliment epatiku sever (Child-Pugh klassi Ċ).
English: Ecchymosis, Pruritus
Maltese: Eċċimosi, Ħakk
English: Samsca 15 mg and Samsca 30 mg tablets are available as 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Maltese: Samsca 15 mg u Samsca 30 mg pilloli huma disponibbli bħala 10 × 1 pillola f'folji tal-PVC/Alu perforati ta' doża unika
English: Samsca is contraindicated during pregnancy (see section 4.3).
Maltese: Samsca huwa kontraindikat waqt it-tqala (ara sezzjoni 4.3).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tolvaptan in breast milk (for details see 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fl-annimali wriet li kien hemm eliminazzjoni ta' tolvaptan fil ħalib tas-sider (gћad-dettalji ara 5.3)
English: This effect was seen in all patients, the severe (serum sodium: < 130 mEq/L) and mild (serum sodium: 130 -< 135 mEq/L) subsets and for all disease aetiology subsets (e.g. HF, cirrhosis, SIADH/other).
Maltese: Dan l-effett deher fil-pazjenti kollha, is-sottosetts severi (sodium fis-serum: < 130 mEq/L) u ħfief (sodium fis-serum: 130 - < 135 mEq/L) u għal kull sottosetts ta'
English: Tolvaptan is extensively metabolised by the liver.
Maltese: Tolvaptan jiġi metabolizzat b'mod estensiv mill-fwied.
English: Syncope1, Headache1, Dizziness1
Maltese: Tqalligħ Stitikezza, Dijarea1,
English: Samsca 15 mg: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side.
Maltese: Samsca 15 mg: Pilloli blu, triangolari, kemxejn mbewqa b'dimensjonijiet ta' 6.58 × 6.2 × 2.7 mm b'“OTSUKA” u “15” fuq naħa waħda.
English: Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets
Maltese: Samsca 7.5 mg pilloli Samsca 15 mg pilloli Samsca 30 mg pilloli
English: Other medicines and Samsca
Maltese: Mediċini oħra u Samsca
English: Samsca 7.5 mg tablets tolvaptan
Maltese: Samsca 7.5 mg pilloli tolvaptan
English: • if you had an allergic reaction in the past to benzazepine, tolvaptan or other benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine), or to any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk kellek reazzjoni allerġika fil-passat għal benzazepine, tolvaptan jew derivati oħra ta' benzazepine (eż. benazepril, conivaptan, fenoldopam mesylate jew mirtazapine) jew għal xi sustanza oħra ta' din il-mediċina fil-passat (imniżżla f'sezzjoni 6)
English: Use of tolvaptan in combination with other options may increase the risk of overly rapid correction of serum sodium (see sections 4.4 and 4.5).
Maltese: għażliet oħra jista' jżid ir-riskju ta' korrezzjoni rapida żżejjed ta' sodium fis-serum (ara sezzjonijiet 4.4 u 4.5).
English: Liver injury induced by tolvaptan was observed in clinical trials investigating a different indication (autosomal dominant polycystic kidney disease [ADPKD]) with long-term use of tolvaptan at higher doses than for the approved indication (see section 4.8).
Maltese: Ġie osservat li kien hemm ħsara fil-fwied indotta b'tolvaptan fil-provi kliniċi li stħarrġu indikazzjoni differenti (marda awtosomali dominanti poliċistika tal-kliewi [ADPKD]) bl-użu fuq tul ta' żmien ta' tolvaptan f'dożi aktar qawwija għall-indikazzjoni approvata (ara sezzjoni 4.8).
English: Samsca 7.5 mg tablets
Maltese: Samsca 7.5 mg pilloli
English: CYP3A4 inducers
Maltese: Induċaturi ta' CYP3A4
English: • Hypernatremia
Maltese: • Ipernatremja
English: 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Maltese: 10 × 1 pillola f'folji tal-PVC/Alu perforati ta' doża unika 30 × 1 pillola f'folji tal-PVC/Alu perforati ta' doża unika
English: Excipient with known effect 35 mg lactose (as monohydrate) per tablet
Maltese: 35 mg lactose (bħala monohydrate) f'kull pillola.
English: In addition, an increased incidence of significant elevations of ALT was observed in patients treated with tolvaptan [4.4 % (42/958)] compared to those receiving placebo [1.0 % (5/484)].
Maltese: Barra minn hekk, inċidenza ogħla ta' żieda sinifikanti ta' ALT kienet osservata f'pazjenti trattati b'tolvaptan [4.4 % (42/958)] meta mqabbla ma' dawk li rċevew plaċebo [1.0 % (5/484)].
English: Samsca 7.5 mg: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side.
Maltese: Samsca 7.5 mg: Pilloli blu, rettangolari, kemxejn mbewqa b'dimensjonijiet ta' 7.7 × 4.35 × 2.5 mm,
English: Samsca 30 mg tablets
Maltese: Samsca 30 mg pilloli
English: In these clinical trials, clinically significant increases (greater than 3 × Upper Limit of Normal) in serum alanine aminotransferase (ALT), along with clinically significant increases (greater than 2 × Upper Limit of Normal) in serum total bilirubin were observed in 3 patients treated with tolvaptan.
Maltese: Limitu ta' Fuq tan-Normal) tal-bilirubina totali fis-serum kienu osservati fi 3 pazjenti trattati b'tolvaptan.
English: Samsca 15 mg tablets
Maltese: Samsca 15 mg pilloli
English: Nausea
Maltese: Disgewsja
English: Samsca 30 mg tablets tolvaptan
Maltese: Samsca 30 mg pilloli tolvaptan
English: Tolvaptan is a selective vasopressin V2-receptor antagonist that specifically blocks the binding of arginine vasopressin (AVP) at the V2-receptor of the distal portions of the nephron.
Maltese: arginine vasopressin (AVP) fir-riċetturi V2 tal-porzjonijiet tat-tarf (distal portions) tan-nefron.
English: Idiosyncratic hepatic toxicity
Maltese: GĦAMLA FARMAĊEWTIKA
English: In a pilot, randomized (1:1:1), double-blind trial in 30 patients with hyponatremia secondary to SIADH, the pharmacodynamics of tolvaptan following single doses of 3.75, 7.5 and 15 mg were assessed.
Maltese: SIADH, il-farmakodinamiċi ta' tolvaptan wara dożi uniċi ta' 3.75, 7.5 u 15 mg ġew valutati.
English: Caution should be exercised in coadministering CYP3A4 inhibitors (e.g. ketoconazole, macrolide antibiotics, diltiazem) with tolvaptan (see section 4.4).
Maltese: (eż. ketoconazole, antibijotiċi macrolide, diltiazem) jingħataw flimkien ma' tolvaptan (ara sezzjoni 4.4).
English: Renal and urinary disorders
Maltese: Żbokk urinarju mxekkel
English: Samsca 15 mg tablets tolvaptan
Maltese: Samsca 15 mg pilloli tolvaptan
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-prodott mediċinali.
English: Excipient with known effect 51 mg lactose (as monohydrate) per tablet
Maltese: Eċċipjent b'effett magħruf 51 mg lactose (bħala monohydrate) f'kull pillola.
English: Mean maximal changes in serum sodium were highest following the 15 mg dose (7.9 mmol/L) but median maximal changes were highest for the 7.5 mg dose (6.0 mmol/L).
Maltese: Bidliet massimi medji tas-sodium fis serum kienu l-ogħla wara doża ta' 15 mg (7.9 mmol/L) imma l-bidliet massimi medjani kienu l-ogħla għad-doża ta' 7.5 mg (6.0 mmol/L).
English: There is no experience from controlled clinical trials with concomitant use of Samsca and other treatments for hyponatremia such as hypertonic sodium chloride solution, oral sodium formulations, and medicinal products that increase serum sodium concentration.
Maltese: M'hemmx esperjenza minn provi kliniċi b'kontrolli bl-użu ta' Samsca flimkien ma' kura oħra għal iponatrimija bħal soluzzjoni ta' sodium chloride ipertonika, formulazzjonijiet orali ta' sodium u prodotti mediċinali li jżidu l-konċentrazzjoni tas-sodium fis-serum.
English: EU/1/09/539/001 (10 × 1 tablet) EU/1/09/539/002 (30 × 1 tablet)
Maltese: EU/1/09/539/001 (10 × 1 pillola) EU/1/09/539/002 (30 × 1 pillola)
English: Tolvaptan affinity for the human V2-receptor is 1.8 times that of native AVP.
Maltese: affinità ta' tolvaptan għar-riċettur V2 tal-bniedem hija 1.8 darbiet aktar minn dik ta' AVP indiġenu.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu.
English: • raised levels of creatinine in the blood.
Maltese: • livelli ogħla ta' kreatinina fid-demm.
English: EU/1/09/539/003 (10 × 1 tablet) EU/1/09/539/004 (30 × 1 tablet)
Maltese: EU/1/09/539/003 (10 × 1 pillola) EU/1/09/539/004 (30 × 1 pillola)
English: The effect of mildly or moderately impaired hepatic function (Child-Pugh classes A and B) on the pharmacokinetics of tolvaptan was investigated in 87 patients with liver disease of various origins.
Maltese: L-effett ta' funzjoni epatika indebolita b'mod ħafif jew moderat (klassijiet A u B ta' Child-Pugh) fuq il-farmakokinetiċi ta' tolvaptan kien mistħarreġ f'87 pazjent b'mard tal-fwied li ġej minn oriġini diversa.
English: Samsca 30 mg: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side.
Maltese: Samsca 30 mg: Pilloli blu, tondi, kemxejn mbewqa, b'dimensjonijiet ta' Ø8 × 3.0 mm b' “OTSUKA”
English: Administration of tolvaptan may cause too rapid increases in serum sodium (≥ 12 mmol/L per 24 hours, please see below); therefore, monitoring of serum sodium in all patients must start no later than 4-6 hours after treatment initiation.
Maltese: L-għoti ta' tolvaptan jista' jikkaġuna żieda qawwija wisq fil-livell ta' sodium fis-serum (≥ 12 mmol/L kull 24 siegħa ara taħt); għalhekk, il-monitoraġġ ta' sodium fis-serum fil-pazjenti kollha irid jinbeda mhux aktar tard minn 4-6 sigħat minn wara l-bidu tat-trattament.
English: EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
Maltese: EU/1/09/539/005 (10 pilloli) EU/1/09/539/006 (30 pilloli) EU/1/09/539/007 (10 × 1 pillola) EU/1/09/539/008 (30 × 1 pillola)