FrancophonIA/ELRC3.0 huggingface dataset:
English: Diovan and associated names 3 mg/ml oral solution Valsartan
Maltese: Diovan u ismijiet asso jati 3 mg/ml ta' soluzzjoni orali
English: • muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
Maltese: • spa mi fil-muskoli, ritmu tal-qalb mhux normali (sinjali ta' iperkalimja)
English: • Do not store above 30°C.
Maltese: • Ta inx f'temperatura ‘l fuq minn 30°C.
English: AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia); see also section 5.3 “Preclinical safety data”.
Maltese: Espo izzjoni g al terapija b'AIIRAs waqt it-tieni u t-tielet trimestru hija mag rufa li tindu i tossi ità lill-fetu uman (funzjoni renali mnaqqsa, fluwidu amnjotiku mhux suffi jenti, ittardjar ta' lossifikazzjoni tal-qorrieg a tar-ras) u tossi ità neonatali (insuffi jenza renali, pressjoni baxxa, iperkalimja); ara wkoll sezzjoni 5.3 “Tag rif ta' qabel l-u u kliniku dwar is-sigurtà tal-medi ina”.
English: The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed below according to system organ class.
Maltese: L-ADRs irrapportati mill-istudji klini i, mill-esperjenza ta' wara t-tqeg id fis-suq u minn sejbiet tallaboratorju huma mni la hawn ta t skond is-sistema tal-klassifika tal-organi.
English: Renal function and serum potassium should be closely monitored during treatment with valsartan.
Maltese: G andu jsir monitora mill-qrib tal-funzjoni renali u tal-potassju fis-serum.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Maltese: ID-DETENTUR TA' L-AWTORIZZAZZJONI G AT-TQEG ID FIS-SUQ [Ara Anness I - Biex timtela mill-pajji partikolari]
English: Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance).
Maltese: Wara g oti ol-vini, tne ija mill-pla ma ta' valsartan hija madwar 2 l/h u t-tne ija renali tieg u hija 0.62 l/h (madwar 30% tat-tne ija totali).
English: This may soften your stools.
Maltese: Valsartan mhux probabbli li jitne a permezz ta' emodijalisi.
English: common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Maltese: Dawn l-effetti sekondarja jistg u jse u b' ertu frekwenzi, li huma definiti kif ej: komuni afna: jaffettwaw aktar minn persuna wa da minn kull 10 li qed ju awh komuni: jaffettwaw minn persuna wa da sa 10 minn kull 100 li qed ju awh mhux komuni: jaffettwaw minn persuna wa da sa 10 minn kull 1,000 li qed ju awh rari: jaffettwaw minn persuna wa da sa 10 minn kull 10,000 li qed ju awh rari afna: jaffettwaw inqas minn persuna wa da minn kull 10,000 li qed ju awh mhux mag ruf: il-frekwenza ma tistax ti i stmata mit-tag rif disponibbli.
English: Drink the entire solution right away.
Maltese: Oqg od f'po izzjoni dritta.
English: In rats, maternally toxic doses (600 mg/kg/day) during the last days of gestation and lactation led to lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6).
Maltese: Fil-firien, do i tossi i g all-omm (600 mg/kg/kuljum) waqt l-a ar ranet tat-tqala u treddieg wasslu g al sopravivenza aktar baxxa, jieda aktar baxxa fil-pi u ttardjar fl-i vilupp (stakkar tal-parti ta' barra tal-widna u ftu tal-kanal tal-widna) fil-frie (ara sezzjoni 4.6).
English: Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000 fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Maltese: Valsartan ma jurix attività agonista parzjali fir-ri ettur AT1 u g andu affinità ferm aktar og la (madwar 20,000 darba) g ar-ri ettur AT1 milli g ar-ri ettur AT2.
English: Do not store above 30°C.
Maltese: Ta inx f'temperatura ‘l fuq minn 30°C.
English: Depending on the prescribed dose, it may be necessary to repeat steps 10 to 16 several times.
Maltese: Skont id-do a preskritta, jista' jkun ne essarju li tirrepeti l-passi 10 sa 16 bosta drabi.
English: Myalgia
Maltese: Iperkalimja
English: Ear and labyrinth system disorders Uncommon
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Mhux komuni
English: • purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)
Maltese: • ponot omor fil-vjola, deni, akk (sinjali ta' infjammazzjoni tal-vini u l-arterji msej a vaskulite)
English: Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Maltese: Barra dan, l-u u ta' antagonisti ta' angiotensin II flimkien ma' NSAIDs jista' jwassal g al jieda fir-riskju ta' rkadar tal-funzjoni renali u jieda fil-potassium fis-serum.
English: • if you are below 18 years of age and you take Diovan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and the amount of potassium in your blood at regular intervals.
Maltese: • jekk g andek inqas minn 18-il sena u qed tie u Diovan flimkien ma' medi ini o ra li jinibixxu s-sistema renin-angiotensin-aldosterone (medi ini li jbaxxu l-pressjoni tad-demm), it-tabib tieg ek jista' ji ekkja l-funzjoni tal-kliewi tieg ek u l-ammont ta' potassju fid-demm tieg ek fintervalli regolari.
English: o In the pharmacovigilance plan: Targeted checklists for follow up of adverse events listed above as potential risks in the paediatric population A study primarily aimed at establishing the long-term safety in CKD and non-CKD paediatric patients.
Maltese: Listi ta' kontroll immirati g as-segwitu tal-avvenimenti avversi elenkati hawn fuq b ala riskji potenzjali fil-popolazzjoni pedjatrika Studju primarjament immirat lejn l-istabbiliment ta' sigurtà fit-tul f'pazjenti pedjatri i CKD u mhux CKD.
English: Take special care with Diovan:
Maltese: Jekk tie u Diovan aktar milli suppost:
English: What Diovan looks like and contents of the pack Diovan 3 mg/ml oral solution is a clear, colourless to pale yellow solution.
Maltese: Id-Dehra ta' Diovan u l-kontenuti tal-pakkett Diovan ta' 3 mg/ml soluzzjoni orali hija soluzzjoni ara, bejn trasparenti u kulur isfar ar.
English: • headache
Maltese: • tqallig
English: Do not take Diovan:
Maltese: Jekk tieqaf tie u Diovan:
English: The Risk Management Plan should include the following: o In the safety specification: results of juvenile safety studies regarding the risk of nephrotoxicity and its relevance for the use in the different paediatric groups paediatric exposure in clinical trials and in post marketing use by age group, indication (including off label use), dose, duration of use, gender and ethnicity o As safety concerns: Identified risks: hyperkalemia and hypotension.
Maltese: Il-Pjan g all- estjoni tar-Riskji g andu jinkludi s-segwenti: o Fl-ispe ifikazzjoni tas-sigurtà: ri ultati ta' studji ta' sigurtà fuq i - g a ag rigward ir-riskju ta' nefrotossi ità u rrelevanza tag ha g all-u u fi gruppi pedjatri i differenti espo izzjoni pedjatrika fi provi klini i u fl-u u wara t-tqeg id fis-suq skont ilgrupp tal-età, l-indikazzjoni (inklu l-u u off label), id-do a, kemm idum jintu a, is-sess u l-etni ità o B ala t assib dwar is-sigurtà:
English: Other conditions with stimulation of the renin-angiotensin system In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
Maltese: Kundizzjonijiet o ra bi stimulazzjoni tas-sistema renin-angiotensin F'pazjenti li l-funzjoni renali tag hom tista' tiddependi fuq l-attività tas-sistema renin-angiotensin (e . pazjenti b'insuffi jenza kon estiva tal-qalb severa), kura b'inibituri ta' angiotensin converting enzyme kienet asso jata ma' oligurja u/jew a otemja progressiva u f'ka ijiet rari ma' insuffi jenza renali akuta u/jew mewt.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Maltese: Jekk it-ta lita tkun ne essarja, hija rrakkomandata sorveljanza b'attenzjoni tal-livelli ta' lithium fis-serum.
English: Acute renal failure, Elevation of serum creatinine
Maltese: Insuffi jenza u indeboliment renali, jieda filkrejatinina fis-serum
English: CLINICAL PARTICULARS
Maltese: KLASSIFIKAZZJONI ENERALI
English: The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Maltese: Trabi ta' ommijiet li adu AIIRAs g andhom ji u osservati mill-qrib g all-pressjoni baxxa (ara wkoll sezzjoni 4.3 u 4.4).
English: • unusual bleeding or bruising (signs of thrombocytopenia)
Maltese: • fsada jew tben il mhux tas-soltu (sinjali ta' trombo itopenija)
English: The applicant will initiate a scientific dialogue via the CHMP's Scientific Advice with the involvement of the PDCO for protocol assistance with the aim of gaining further insight on a hypertensive clinical trial in younger children with valsartan and to define objectives and design parameters in investigating the efficacy in this population.
Maltese: L-applikant jag ti bidu g al djalogu xjentifiku mal-Konsulenza Xjentifika tas-CHMP bl-involviment tal-PDCO g al assistenza fil-protokoll bl-g an li jinkiseb aktar intuwitu fuq prova klinika g all-pressjoni g olja fi tfal i g ar b'valsartan u biex jiddefinixxi l-objettivi u jfassal parametri fl-investigazzjoni tal-effika ja f'din il-popolazzjoni.
English: Hypotension, Orthostatic hypotension
Maltese: Pressjoni baxxa , Pressjoni ortostatika baxxa
English: Valsartan does not inhibit ACE (also known as kininase II) which converts Ang I to Ang II and degrades bradykinin.
Maltese: Valsartan ma jinibixxix ACE (mag ruf ukoll b ala kininase II) li jaqleb Ang I g al Ang II u jiddegrada bradykinin.
English: Overall, the dose-dependent antihypertensive effect of valsartan was consistent across all the demographic subgroups.
Maltese: B'mod enerali, l-effett g al kontra l-pressjoni g olja ta' valsartan dipendenti mid-do a kien konsistenti matul is-sotto-gruppi demografi i kollha.
English: Excretion:
Maltese: Bijotrasformazzjoni:
English: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Maltese: Antagonisti tar-Ri etturi ta' Angiotensin II (AIIRAs) m'g andhomx jinbdew waqt it-tqala.
English: - Second and third trimester of pregnancy (see sections 4.4 and 4.6).
Maltese: − It-tieni jew it-tielet trimestru tat-tqala (ara sezzjonijiet 4.4 u 4.6).
English: Pack size: 1 bottle containing 160 ml oral solution
Maltese: Daqs tal-pakkett: flixkun wie ed li fih 160 ml ta' soluzzjoni orali.
English: • Restart the cycle of PSUR submission for Diovan as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Maltese: • Er a' ibda - iklu tas-sottomissjoni ta' PSUR g al Diovan kif ej: o Sitt PSURs fix-xahar sakemm ikunu nkisbu sentejn s a ta' esperjenza bl-indikazzjoni pedjatrika fl-UE o PSURs fis-sena g as-sentejn ta' wara o Wara dawn, sottomissjoni f'intervalli ta' tliet snin Il-PSURs gandhom jiffokaw fuq l-uu fil-popolazzjoni pedjtarika.
English: Excipients:
Maltese: Eskrezzjoni:
English: • that consists of a clear plastic tube with a plunger inside.
Maltese: • li tikkonsisti minn tubu ar tal-plastik bi plan er o fiha.
English: • Diovan solution contains 0.3 g sucrose per millilitre.
Maltese: • Is-soluzzjoni Diovan fiha 0.3 g ta' sucrose g al kull millilitru. omm dan f'mo ok jekk g andek dijabete mellitus.
English: • abdominal pain
Maltese: • u ig addominali
English: Hypersensitivity including serum sickness
Maltese: Sensittività e essiva iklu marda tas-serum
English: Angioedema
Maltese: An joedima
English: Hypertension (paediatric population)
Maltese: Pressjoni g olja (popolazzjoni pedjatrika)
English: Valsartan is not known to bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Maltese: Valsartan mhux mag ruf li je el jew jimblokka ri etturi ta' ormoni o ra jew kanali tal-joni mag rufa li huma importanti fir-regolazzjoni kardjovaskulari.
English: Fatigue
Maltese: Treddig
English: In some cases your doctor may ask you to take up to 80 mg of valsartan (corresponding to 27 ml of the solution).
Maltese: F'xi ka ijiet it-tabib tieg ek jista' jistaqsik sabiex tie u sa 80 mg ta' valsartan (li tikkorrispondi ma' 27 ml ta' soluzzjoni).
English: Impaired hepatic function
Maltese: Indebiloment fil-funzjoni epatika
English: These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of
Maltese: Fil-firien dawn id-do i (200 sa 600 mg/kg/kuljum) huma madwar 6 u 18-il darba og la mid-do a massima rrakkomandata fil-bniedem fuq ba i ta' mg/m2
English: • dizziness
Maltese: Dijabete
English: • increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)
Maltese: • jieda fil-livell ta' nitrogen mill-urea fid-demm u jieda fil-livell ta' krejatinina fis-serum (li jistg u jindikaw funzjoni tal-kliewi mhux normali)
English: CARTON/BOTTLE LABEL
Maltese: KARTUNA/TIKETTA FUQ IL-FLIXKUN
English: Renal and urinary disorders Common
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Komuni
English: In another clinical study involving 300 hypertensive paediatric patients 6 to 18 years of age, eligible patients were randomized to receive valsartan or enalapril tablets for 12 weeks.
Maltese: Fi studji klinii orajn li kienu jinkludu 300 pazjent pedjatriku ta' bejn 6 u 18 -il sena bil-pressjoni golja, pazjenti eliibbli ew randomised sabiex jirievu valsartan jew pilloli enalapril gal 12 -il imga.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Maltese: Meta ssir dijanjosi ta' tqala kura b'AIIRAs g andha titwaqqaf minnufih, u jekk xieraq g andha tinbeda terapija alternattiva.
English: • breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)
Maltese: • qtug ta' nifs, diffikultà biex tie u n-nifs meta mimdud, nef a fis-saqajn jew ri lejn (sinjali ta'
English: Because of these inconsistencies, valsartan is not recommended in this age group (see section 4.8).
Maltese: Min abba f'dawn l-inkonsistenzi, valsartan mhuwiex rakkomandat f'dan il-grupp ta' età (ara sezzjoni 4.8).
English: An oral dosing syringe:
Maltese: Oqg od attent afna b'Diovan:
English: This is a disease in which your adrenal glands make too much of the hormone aldosterone.
Maltese: Din hija marda fejn il-glandoli adrenali tieg ek jipprodu u ammont ejjed ta' l-ormon aldosterone.
English: In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan.
Maltese: F'pazjenti bi tnaqqis sever fis-sodium u/jew fil-volum, b al dawk li qed jir ievu do i g olja ta' dijureti i, f'ka ijiet rari tista' sse pressjoni baxxa sintomatika wara l-bidu tat-terapija b'Diovan.
English: Elevation of liver function values
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI
English: Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Sakemm terapija kontinwata b'AIIRAs mhux ikkunsidrata essenzjali, pazjenti li qed jippjanaw tqala g andhom jinqalbu g all-kura o ra li tbaxxi l-pressjoni li g andha profil ta' sigurtà stabbilit g al u u waqt ittqala.
English: Valsartan is not biotransformed to a high extent as only about 20% of dose is recovered as metabolites.
Maltese: Valsartan ma ji ix bijotrasformat b'mod estensiv peress li madwar 20% biss tad-do a hija rkuprata b ala metaboliti.
English: Respiratory, thoracic and mediastinal disorders Uncommon
Maltese: Disturbi respiratorji, tora i i u medjastinali Mhux komuni
English: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss ta' valsartan wara g oti ol-vini huwa ta' madwar 17 -il litru, u dan jindika li ma sse x distribuzzjoni estensiva ta' valsartan fit-tessuti.
English: Hyperkalaemia was more frequently observed in children and adolescents aged 6 to 18 years with underlying chronic kidney disease.
Maltese: L-iperkalemija kienet osservata b'mod iktar frekwenti fit-tfal u l-adolexxenti minn 6 sa 18 -il sena li kellhom mard kroniku tal-fwied.
English: Children less than 6 years of age
Maltese: Tfal ta' inqas minn 6 snin
English: With the exception of isolated gastrointestinal disorders (like abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to 18 years and that previously reported for adult patients.
Maltese: L-effett ta' kontra l-pressjoni g olja ta' valsartan ie evalwat f' ew studji klini i randomised doubleblind fuq 561 pazjent pedjatriku minn 6 sa 18 -il sena. lief meta hemm disturbi gastro-intestinali i olati (b al u ig addominali, tqallig , rimettar) u sturdament, ma ew identifikati l-ebda differenzi relevanti f'dak li g andu x'jaqsam mat-tip, frekwenza u severità ta' reazzjonijiet avversi bejn il-profil ta' sigurtà g al pazjenti pedjatri i li g andhom minn 6 sa 18 -il sena u dak g all-pazjenti adulti.
English: Musculoskeletal and connective tissue disorders Not known
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Mhux mag rufa
English: • certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
Maltese: • ertu tip ta' pilloli li jmewtu l-u ig imsej a medi ini anti-infjammatorji mhux sterojdi
English: Rash, Pruritis
Maltese: Raxx, akk
English: Section 4.3 Contraindications
Maltese: Sezzjoni 4.3 - Kontraindikazzjonijiet
English: Surgery and trauma:
Maltese: Kirurġija u trawma:
English: (see sections 4.2, 4.3 and 4.4)
Maltese: (ara s-sezzjonijiet 4.2, 4.3 u 4.4)
English: Do not use <Product name> if you:
Maltese: Tużax <Product name> jekk:
English: - hypersensitivity to the active substances or to any of the other excipients listed in section 6.1 - sepsis - burns - renal impairment or renal replacement therapy - intracranial or cerebral haemorrhage - critically ill patients (typically admitted to the intensive care unit) - hyperhydration - pulmonary oedema - dehydration
Maltese: - sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1. - infezzjoni fid-demm (sepsis) - ħruq - indeboliment renali jew terapija ta' sostituzzjoni tal-kliewi - emorraġija intrakranjali jew ċerebrali - pazjenti morda b'mod kritiku (ġeneralment ammessi fl-unità tal-kura intensiva) - iperidrazzjoni - edema pulmonari - deidrazzjoni
English: • suffer from serious generalised infection (sepsis)
Maltese: • issofri minn infezzjoni ġeneralizzata serja (sepsis)
English: The maximum daily dose is <30ml/kg for 6% HES (130/0.40) and 6% HES (130/0.42); for other HES products the maximum daily dose should be recalculated accordingly>.
Maltese: Id-doża massima ta' kuljum hija <30 ml/kg għal 6 % HES (130/0.
English: Serum electrolytes, fluid balance and renal function should be monitored closely.
Maltese: Elettroliti fis-serum, il-bilanċ tal-fluwidu u l-funzjoni renali għandhom jiġu ssorveljati mill-qrib.
English: (see section 4.2)
Maltese: (ara s-sezzjoni 4.2)
English: HES products are contraindicated in patients with renal impairment or renal replacement therapy (see section 4.3).
Maltese: Prodotti HES huma kontraindikati f'pazjenti b'indeboliment renali jew fuq terapija ta' sostituzzjoni renali (ara s-sezzjoni 4.3).
English: Dosage
Maltese: Dożaġġ
English: Section 4.8 Undesirable effects [This following wording should be reflected in this section]
Maltese: Sezzjoni 4.8 Effetti mhux mixtieqa [Il-formulazzjoni li ġejja għandha tiġi riflessa f'din is-sezzjoni]
English: • have fluid in the lungs (pulmonary oedema)
Maltese: • għandek fluwidu fil-pulmun (edema pulmonari)
English: The product information shall be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott għandha tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti tal-Istati Membri, b'kollaborazzjoni mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stabbiliti fil-Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: (See also section 4.2.)
Maltese: (Ara wkoll sezzjoni 4.2.)
English: If impaired kidney function occurs during therapy:
Maltese: Jekk ikun hemm funzjoni indebolita tal-kliewi matul it-terapija:
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Maltese: Ġie irrapportat żieda fil-ħtieġa ta' terapija ta' sostituzzjoni renali sa 90 jum wara l-għoti ta' HES.
English: Monitoring of renal function in patients is recommended for at least 90 days.
Maltese: Issorveljanza tal-funzjoni tal-kliewi fil-pazjenti hija rrakkomandata għal tal-anqas 90 jum.
English: • impairment of your liver function
Maltese: • irċevejt trapjant ta' organu
English: - severe hypernatraemia or severe hyperchloraemia - severely impaired hepatic function
Maltese: - iperkalemija [applikabbli biss għall-prodotti li fihom il-potassju] - ipernatremija severa jew iperkloremija severa
English: Section 4.2 Posology and method of administration
Maltese: Sezzjoni 4.2 -Pożoloġija u metodu ta' kif għandu jingħata
English: Package Leaflet <This medicine is subject to additional monitoring.
Maltese: <Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: • have severely impaired liver function
Maltese: • indeboliment fill-funzjoni tal-fwied tiegħek
English: Possible side effects [This section should be amended to include the below wording]
Maltese: Effetti sekondarji possibbli [Din is-sezzjoni għandha tiġi emendata biex tinkludi l-formulazzjoni li ġejja]
English: Use in children
Maltese: Twissijiet u prekawzjonijiet
English: If the doctor detects first signs of kidney impairment he/she will stop giving you this medicine.
Maltese: Jekk it-tabib jidentifika l-ewwel sinjali ta' indeboliment tal-kliewi, huwa/hija ser jieqaf/tieqaf jagħtik/tagħtik din il-mediċina.
English: Use of HES should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 h.
Maltese: L-użu ta' HES għandu jiġi ristrett għall-fażi inizjali ta' risuxxitazzjoni tal-volum b'intervall ta' ħin massimu ta' 24 siegħa.
English: How to use <Product name>
Maltese: Kif għandek tuża <Product name>
English: • blood clotting (coagulation) disorders
Maltese: • disturbi fil-koagulazzjoni tad-demm (koagulazzjoni)
English: In patients undergoing open heart surgery in association with cardiopulmonary bypass the use of HES products is not recommended due to the risk of excess bleeding.
Maltese: F'pazjenti li jkunu qegħdin jagħmlu kirurġija tal-qalb miftuħa flimkien ma' bypass kardjopulmonari, lużu ta' prodotti HES mhux irrakkomandat minħabba r-riskju ta' fsada eċċessiva.
English: Hepatic injury < frequency not known (cannot be estimated from the available data)> Renal injury < frequency not known (cannot be estimated from the available data)>
Maltese: Frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli)>