FrancophonIA/ELRC3.0 huggingface dataset:
English: 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: Pilloli blu, rettangolari, kemxejn mbewqa b'dimensjonijiet ta' 7.7 × 4.35 × 2.5 mm, b'“OTSUKA” u
English: The primary objective of the study was to compare the effects of tolvaptan + SC with placebo + SC on the time to all-cause mortality and on the time to first occurrence of cardiovascular (CV) mortality or hospitalisation for HF. Tolvaptan treatment had no statistically significant favourable or unfavourable effects on overall survival or the combined endpoint of CV mortality or HF hospitalisation, and did not provide convincing evidence for clinically relevant benefit.
Maltese: It-trattament b'tolvaptan ma kellu ebda effett statistikament sinifikanti kemm favorevoli jew mhux favorevoli, fuq is-sopravivenza globali jew l endpoint ikkombinat għal mortalità kardjovaskulari jew it-teħid l-isptar għal insuffiċjenza kardijaka, u ma pprovdiex evidenza konvinċenti għal siwi klinikament rilevanti.
English: Hyponatremia
Maltese: MEDIĊINALI
English: Even though this increase has no clinical relevance, it indicates tolvaptan can potentially increase exposure to CYP3A4 substrates.
Maltese: Anke jekk din iż-żieda m'għandhiex rilevanza klinika, tindika li tolvaptan jista' jżid l-espożizzjoni għal substrati ta' CYP3A4.
English: Tolvaptan was superior to placebo (p < 0.0001) for both periods in both studies.
Maltese: Tolvaptan kien superjuri għal plaċebo (p < 0.0001)
English: Samsca 15 mg tablets and Samsca 30 mg tablets 4 years
Maltese: Samsca 15 mg pilloli u Samsca 30 mg pilloli 4 snin
English: During titration, patients must be monitored for serum sodium and volume status (see section 4.4).
Maltese: Waqt it-titrazzjoni l-pazjenti jridu jiġu monitorati għall-istat tal-volum u sodium fis-serum (ara sezzjoni 4.4).
English: Teratogenicity was noted in rabbits given 1,000 mg/kg/day (up to 15 times the exposure in humans at the 60 mg dose, based on AUC).
Maltese: It-teratoġeniċità kienet innotata fi fniek li ġew mogħtija 1,000 mg/kg/jum (sa 15-il darba lespożizzjoni għal bniedem fid-doża ta' 60 mg, abbażi tal-AUC).
English: Mean change from baseline in cumulative urine volume and urine excretion rates was 2-fold higher for the 15 mg dose compared to the 7.5 and 3.75 mg doses, which showed similar responses.
Maltese: Bidla medja mill-volum ta' awrina kumulattiva fil-linja bażi u r-rati ta' eliminazzjoni fl-awrina kienu darbtejn ogħla għad-doża ta' 15 mg meta mqabbla mad-dożi ta' 7.5 u 3.75 mg, li wrew rispons simili.
English: In a post-authorisation safety study of tolvaptan in hyponatremia secondary to SIADH, including a high proportion of patients with tumours (especially Small Cell Lung Cancer), patients with low baseline serum sodium as well as patients with concomitant use of diuretics and/or sodium chloride solution the incidence of rapid correction of hyponatremia was found to be higher than in clinical trials.
Maltese: Fi studju tas-sigurtà ta' wara t-tqegħid fis-suq ta' tolvaptan f'iponatrimija sekondarja għal SIADH, li kien jinkludi proporzjon għoli ta' pazjenti b'tumuri (speċjalment Kanċer ta' Ċelloli Żgħar tal-Pulmun), pazjenti b'livell baxx mil-linja bażi ta' sodium fis-serum kif ukoll pazjenti li kienu qed jużaw dijuretiċi u/jew soluzzjoni ta' sodium chloride fl-istess waqt l-inċidenza ta' korrezzjoni mgħaġġla ta'
English: • find a swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).
Maltese: • ikollok nefħa fuq il-wiċċ, ix-xofftejn jew l-ilsien, ħakk, raxx ġeneralizzat, jew tħarħir sever jew nuqqas ta' nifs (sintomi ta' reazzjoni allerġika).
English: In a population pharmacokinetic analysis in patients with hepatic oedema, AUC of tolvaptan in severely (Child-Pugh class C) and mildly or moderately (Child-Pugh classes A and B) hepatic impaired patients were 3.1 and 2.3 times higher than that in healthy subjects.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni f'pazjenti f'edema epatika, l-AUC ta' tolvaptan f'pazjenti bil-fwied indebolit b'mod sever (Child-Pugh klassi Ċ), u b'mod ħafif jew moderat (Child-Pugh
English: • Anuria
Maltese: • Anurja
English: In the long-term outcome trial, a total of 2,072 patients received 30 mg tolvaptan with standard of care (SC) and 2,061 received placebo with SC.
Maltese: 30 mg ta' tolvaptan b'kura standard u 2,061 irċevew plaċebo b'kura standard.
English: Anaphylactic shock,
Maltese: Xokk anafilattiku,
English: Each tablet contains 7.5 mg tolvaptan.
Maltese: Kull pillola fiha 7.5 mg tolvaptan.
English: Individual maximal increases in serum sodium were negatively correlated with fluid balance; mean change in fluid balance showed a dose dependent decrease.
Maltese: Żidiet massimi individwali tas-sodium fis-serum kienu korrelatati negattivament bil-bilanċ ta' fluwidu; bidla medja fil-bilanċ ta' fluwidu wera tnaqqis dipendenti fuq id doża.
English: EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan) was a long-term outcome, double-blind, controlled clinical trial in patients hospitalised with worsening HF and signs and symptoms of volume overload.
Maltese: EVEREST (Effikaċja ta' Antagoniżmu Vasopressin fi Studju tar-Riżultat ta' Insuffiċjenza tal-Qalb b'Tolvaptan) kienet prova klinika li kellha riżultati għal tul ta' żmien, ikkontrollata, double-blind, għal pazjenti li kienu l-isptar b'insuffiċjenza kardijaka li kienet sejra għall-agħar u sinjali u sintomi ta' volum eċċessiv.
English: Samsca 7.5 mg tablets 5 years
Maltese: Samsca 7.5 mg pilloli 5 snin
English: Tolvaptan may cause hyperglycemia (see section 4.8).
Maltese: jkollha riskju ta' demajlinazzjoni osmotika (ara sezzjoni 4.4).
English: Following single oral doses of ≥ 300 mg, peak plasma concentrations appear to plateau, possibly due to saturation of absorption.
Maltese: Wara dożi waħidhom ta' ≥ 300 mg, il-konċentrazzjonijiet massimi fil-plażma jidhru li jilħqu massimu, possibilment minħabba saturazzjoni mill-assorbiment.
English: The mean serum sodium concentration at trial entry was 129 mEq/L (range 114-136).
Maltese: Ilkonċentrazzjoni medja ta' sodium fis-serum fil-bidu tal-prova kienet ta' 129 mEq/L(medda ta'
English: • fever
Maltese: • sturdamen
English: Pruritic rash1
Maltese: Raxx bil ħakk1
English: Asthenia, Pyrexia, Malaise1
Maltese: Polidipsija, Deidratazzjoni, Iperkalimja,
English: Samsca is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Maltese: tnixxija mhux xierqa ta' ormon antidjuretiku (SIADH).
English: In addition to its renal aquaretic effect, tolvaptan is capable of blocking vascular vasopressin V2receptors involved in the release of coagulation factors (e.g., von Willebrand factor) from endothelial cells.
Maltese: vasopressin vaskulari V2 involuti fir-rilaxx ta' fatturi ta' koagulazzjoni (eż. il-fattur von Willebrand)
English: Concomitant use of Samsca with other treatments for hyponatremia or other medicinal products that increase serum sodium concentration may result in a higher risk for developing rapid correction of serum sodium (see section 4.4) and is therefore not recommended during initial treatment or for other patients with very low baseline serum sodium concentrations where rapid correction may represent a risk for osmotic demyelination (see section 4.4).
Maltese: kura oħra għal iponatrimija jew prodotti mediċinali oħra li jżidu l-konċentrazzjoni tas-sodium fisserum jistgħu jirriżultaw f'riskju ogħla li tiżviluppa korrezzjoni rapida ta' sodium fis-serum (ara sezzjoni 4.4), u għalhekk mhux rakkomandat waqt kura inizjali jew għal pazjenti oħrajn b'konċentrazzjonijiet ta' sodium fis-serum fil-linja bażi baxxi ħafna fejn korrezzjoni rapida jista'
English: • The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake (E 132).
Maltese: • Is-sustanzi l-oħra huma lactose monohydrate, maize starch, microcrystalline cellulose,
English: (ADPKD)
Maltese: • ħakk
English: Steady state digoxin concentrations have been increased (1.3-fold increase in maximum observed plasma concentration [Cmax] and 1.2-fold increase in area under the plasma concentration-time curve over the dosing interval [AUCτ]) when co administered with multiple once daily 60 mg doses of tolvaptan.
Maltese: Konċentrazzjonijiet ta' digoxin fl-istat fiss żdiedu (żieda ta' 1.3 darbiet fil-konċentrazzjoni massima osservata fil-plażma [Cmax] u żieda ta' 1.2 darbiet fl-erja taħt il-kurva tal-konċentrazzjoni fil-plażma mal-ħin fuq l-intervall tad-dożaġġ)
English: Hepatic disorders2 Acute hepatic failure3
Maltese: Insuffiċjenza tal-fwied akuta3
English: Rapid correction of hyponatremia, sometimes leading to neurological symptoms observed in clinical trials investigating other indications from post-authorisation safety study in hyponatremia secondary to SIADH observed in post-marketing with tolvaptan in ADPKD.
Maltese: L-istat ta' fluwidu u elettroliti irid jiġi monitorat fil-pazjenti kollha partikolarment f'dawk li għandhom indeboliment renali u epatiku.
English: • tiredness, general weakness
Maltese: • għeja, debbulizza ġenerali
English: • diltiazem (treatment for high blood pressure and chest pain),
Maltese: • diltiazam (trattament għal pressjoni tad-demm għolja u uġigħ fis-sider),
English: The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst and dehydration/hypovolemia (profuse and prolonged aquaresis).
Maltese: Is-sinjali u s-sintomi ta' doża eċċessiva akuta huma mistennija li jkunu dawk ta' effett farmakoloġiku eċċessiv: żieda fil-konċentrazzjoni tas-sodium fis-serum, poliurja, għatx u deidratazzjoni/ipovolemija
English: Samsca 15 mg and Samsca 30 mg tablets
Maltese: Samsca 15 mg pilloli u Samsca 30 mg pilloli
English: • liver problems
Maltese: • Iponatrimija ipovolemika
English: Generalised rash
Maltese: Ħalq xott
English: {MM/YYYY}
Maltese: TA' EĊĊIPJENTI
English: Polydipsia, Dehydration, Hyperkalemia, Hyperglycemia, Hypoglycemia1, Hypernatremia1, Hyperuricemia1, Decreased appetite
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: In case serum sodium increases ≥ 12 mmol/L within 24 hours or ≥ 18 mmol/L within 48 hours, tolvaptan treatment is to be interrupted or discontinued followed by administration of hypotonic fluid.
Maltese: F'każ li s-sodium fis-serum jiżdied ≥ 12 mmol/L fi żmien 24 siegħa jew ≥ 18 mmol/L fi żmien 48 siegħa, it-trattament b'tolvaptan għandu jiġi interrot jew mwaqqaf wara l-għoti ta' fluwidu ipotoniku.
English: Samsca contains lactose as an excipient.
Maltese: Samsca fih lactose bħala sustanza mhux attiva.
English: Patients with known hypersensitivity reactions to benzazepine or benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine) may be at risk for hypersensitivity reaction to tolvaptan (see section 4.3 Contraindications).
Maltese: Peress li sensittività eċċessiva hija kontraindikazzjoni (ara sezzjoni 4.3) il-kura qatt m'għandha terġa' tinbeda wara reazzjoni anafilattika jew wara reazzjonijiet allerġiċi serji oħra.
English: Caution has to be exercised in co-administering CYP3A4 inducers (e.g. rifampicin, barbiturates) with tolvaptan.
Maltese: Mhux disponibbli tagħrif dwar pazjenti b'indeboliment epatiku sever (Child-Pugh klassi Ċ).
English: How to store Samsca
Maltese: X'fih Samsca
English: Pharmacokinetics in special patient groups
Maltese: Il-farmakokinetiċi fi gruppi ta' pazjenti speċjali
English: The safety and efficacy of tolvaptan in children and adolescents under the age of 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' tolvaptan fit-tfal u adolexxenti li għadhom m'għalqux it-18-il sena ma ġewx determinati s'issa.
English: Two fertility studies in rats showed effects on the parental generation (decreased food consumption and body weight gain, salivation), but tolvaptan did not affect reproductive performance in males and there were no effects on the foetuses.
Maltese: Żewġ studji dwar il-fertilità fil-firien urew effetti fuq il-ġenerazzjoni tal-ġenituri (tnaqqis fil-konsum tal-ikel u fiż-żieda fil-piż tal-ġisem, salivazzjoni), iżda tolvaptan ma kellux effett fuq l-prestazzjoni riproduttiva fl-irġiel u ma kienx hemm effetti fuq il-feti.
English: • rapid rise in level of sodium.
Maltese: • Is-sustanza attiva hi tolvaptan.
English: Samsca is used to treat low serum sodium levels in adults.
Maltese: Samsca jintuża biex jikkura livelli baxxi ta' sodium fis-serum fl-adulti.
English: Too rapid correction of serum sodium
Maltese: Korrezzjoni mgħaġġla ħafna ta' sodium fis-serum
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula Korrezjoni mgħaġġla ta' iponatrimija
English: Radio labelled tolvaptan experiments showed that 40 % of the radioactivity was recovered in the urine and 59 % was recovered in the faeces where unchanged tolvaptan accounted for 32 % of radioactivity.
Maltese: Sperimenti b'tolvaptan radjutikkettat wrew li 40 % tar-radjuattività kienet irkuprata fl-awrina u 59 %
English: The primary endpoint for these trials was the average daily AUC for change in serum sodium from baseline to Day 4 and baseline to Day 30.
Maltese: L-endpoint primarju f'dawn il-provi kien l-AUC medju ta' kuljum għal bidla tas-sodium fis-serum mil-linja bażi sa Jum 4 u mil-linja bażi sa Jum 30.
English: In patients at higher risk of demyelination syndromes, for example those with hypoxia, alcoholism or malnutrition, the appropriate rate of sodium correction may be lower than that in patients without risk factors; these patients should be very carefully managed.
Maltese: F'pazjenti b'riskju ogħla ta' sindromi ta' dimilinazzjoni, pereżempju dawk b'ipoksja, alkoħoliżmu jew malnutrizzjoni, ir-rata adattata ta' korrezzjoni ta' sodium tista' tkun aktar baxxa minn dik f'pazjenti mingħajr fatturi ta' riskju; dawn il-pazjenti għandhom jiġu ġestiti b'attenzjoni.
English: These findings may suggest that tolvaptan has the potential to cause irreversible and potentially fatal liver injury.
Maltese: Dawn ir-riżultati jistgħu jissuġġerixxu li telvaptan jista' jikkaġuna ġrieħi potenzjali irriversibbli u fatali fil-fwied.
English: Samsca is contraindicated during breast-feeding (see section 4.3).
Maltese: Samsca hu kontraindikat waqt it-treddigħ (ara sezzjoni 4.3).
English: In patients with suspected tolvaptan overdose, assessment of vital signs, electrolyte concentrations, ECG and fluid status is recommended.
Maltese: F'pazjenti b'suspett ta' doża eċċessiva ta' tolvaptan, hija rakkomandata valutazzjoni tas-sinjali vitali,
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTERS
Maltese: FOLJI PERFORATI TA' DOŻA UNIKA
English: What you need to know before you take Samsca Do not take Samsca
Maltese: X'għandek tkun taf qabel ma tieħu Samsca Tiħux Samsca
English: Samsca 15 mg tablets Each tablet contains 15 mg tolvaptan.
Maltese: Samsca 15 mg pilloli Kull pillola fiha 15 mg tolvaptan.
English: For patients at risk of overly rapid correction of sodium e.g. patients with oncological conditions, very low baseline serum sodium, taking diuretics, or taking sodium supplementation a dose of 7.5 mg should be considered (see section 4.4).
Maltese: Għal pazjenti f'riskju ta' korrezzjoni rapida sovrastanti ta' sodju eż. pazjenti b'kundizzjonijiet onkoloġiċi, b'sodju fis-serum fuq linja bażi baxxa ħafna, fuq dijuretiċi jew li qed jieħdu supplimentazzjoni ta' sodju doża ta' 7.5 mg kuljum għandha tiġi kkunsidrata (ara sezzjoni 4.4)
English: The no observed adverse effects level (NOAEL) for effects on reproduction in females (100 mg/kg/day) was about 8-times the total daily dose of 60 mg/day on a mg/m2 basis.
Maltese: Il-livell fejn ma kien osservat l-ebda effett avvers (NOAEL, no adverse effects level) għall-effetti fuq ir-riproduzzjoni fin-nisa (100 mg/kg/jum) kien madwar 8 darbiet id-doża totali ta' kuljum ta'
English: Co-administration of grapefruit juice and tolvaptan resulted in a 1.8-fold increase in exposure to tolvaptan.
Maltese: L-għoti fl-istess ħin ta' meraq tal-grejpfrut u tolvaptan irriżulta f'żieda ta' 1.8 darbiet fl-espożizzjoni għal tolvaptan.
English: The full EPAR for Onduarp can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: EPAR summary for the public telmisartan / amlodipine
Maltese: Sommarju tal-EPAR għall-pubbliku telmisartan / amlodipina
English: The European Commission granted a marketing authorisation valid throughout the European Union for Onduarp on 24 November 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Onduarp fit-24 ta' Novembru 2011.
English: Other information about Onduarp
Maltese: Informazzjoni oħra dwar Onduarp
English: This is a summary of the European public assessment report (EPAR) for Onduarp.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Onduarp.
English: What is Onduarp?
Maltese: X'inhu Onduarp?
English: The maximum dose is one tablet of the highest strength (80/10 mg) once a day.
Maltese: Id-doża massima hija ta' pillola waħda tal-ogħla qawwa (80/10 mg) darba kuljum.
English: The most common side effects with Onduarp (seen in between 1 and 10 patients in 100) are dizziness and peripheral oedema (swelling, especially of the ankles and feet).
Maltese: L-effetti sekondarji l-aktar komuni b'Onduarp (li dehru f'bejn pazjent 1 u 10 pazjenti minn kull 100) huma sturdament u edema periferali (nefħa, speċjalment tal-għekiesi u tas-saqajn).
English: Onduarp is a medicine that contains two active substances, telmisartan and amlodipine.
Maltese: Onduarp huwa mediċina li fiha żewġ sustanzi attivi, telmisartan u amlodipina.
English: In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment).
Maltese: Fi studju ewlieni wieħed, 1,461 adult bl-ipertensjoni rċevew kura b'kombinazzjonijiet tat-telmisartan u l-amlodipine, bit-telmisartan jew bl-amlodipine weħidhom, jew bi plaċebo (kura finta).
English: Onduarp contains two active substances, telmisartan and amlodipine.
Maltese: Onduarp fih żewġ sustanzi attivi, t-telmisartan u l-amlodipina.
English: Why has Onduarp been approved?
Maltese: Għaliex ġie approvat Onduarp?
English: How has Onduarp been studied?
Maltese: Kif ġie studjat Onduarp?
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Maltese: Timblokka kanali speċjali fuq is-superfiċje taċ-ċelloli magħrufa bħala kanali tal-kalċju, li minnhom il-joni tal-kalċju normalment jidħlu fiċ-ċelloli.
English: The company that makes Twynsta has agreed that its scientific data can be used for Onduarp (‘informed consent')
Maltese: Il-kumpanija li tipproduċi Twynsta aċċettat li d-dejta xjentifika tagħha tista' tintuża għal Onduarp (‘kunsens infurmat')
English: What is the risk associated with Onduarp?
Maltese: X'inhu r-riskju assoċjat ma' Onduarp?
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Maltese: Billi jnaqqsu lpressjoni tad-demm, ir-riskji assoċjati mal-pressjoni tad-demm għolja, bħal puplesija, huma mnaqqsa.
English: In the two other studies, Onduarp was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Onduarp and amlodipine, the fall in diastolic blood pressure was greater in patients taking Onduarp by between 1.4 mmHg and 4.9 mmHg.
Maltese: Fiż-żewġ studji l-oħra, Onduarp kien aktar effettiv fit-tnaqqis tal-pressjoni dijastolika tad-demm milli bit-tkomplija ta' kura bl-amlodipina weħidha: skont il-qawwiet ta' Onduarp u l-amlodipina, it-tnaqqis fil-pressjoni dijastolika tad-demm kien akbar f'pazjenti li kienu qegħdin jieħdu Onduarp b'madwar 1.4 mmHg u 4.9 mmHg.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: II hija vażokostrittur qawwi (sustanza li ddejjaq il-vini).
English: Studies were also carried to show that Onduarp tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan.
Maltese: Saru wkoll studji biex juru li l-pilloli ta' Onduarp jiġu assorbiti fil-ġisem bl-istess mod bħal pilloli separati tal-amlodipina u tat-telmisartan.
English: Onduarp must not be used in people who are hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives' class or to any of the other ingredients.
Maltese: Onduarp ma għandux jintuża fuq persuni li huma ipersensittivi (allerġiċi) għat-telmisartan, lamlodipina, għal mediċini oħra fil-klassi tad-‘derivati ta' dihydropyridine' jew għal xi wieħed missustanzi l-oħra.
English: Onduarp must also not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), severe hypotension (low blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack).
Maltese: Onduarp ma għandux jintuża wkoll fuq pazjenti li għandhom problemi severi fil-fwied jew biljarji, xokk (tnaqqis qawwi fil-pressjoni tad-demm), b'ipotensjoni severa (pressjoni tad-demm baxxa), b'ostruzzjoni għallfluss tad-demm min-naħa tax-xellug tal-qalb tagħhom jew f'pazjenti b'insuffiċjenza tal-qalb wara infart mijokardijaku (attakk tal-qalb).
English: This medicine is the same as Twynsta, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Twynsta, li hija diġà awtorizzata fl-Unjoni Ewropea (UE).
English: This summary was last updated in 10-2011.
Maltese: Is-sommarju ġie aġġornat l-aħħar f'10-2011.
English: The company presented information from scientific literature as well as results from studies with the medicine.
Maltese: Il-kumpanija ppreżentat informazzjoni minn letteratura xjentifika kif ukoll riżultati minn studji bilmediċina.
English: For the full list of all side effects reported with Onduarp, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Onduarp, ara l-fuljett ta' tagħrif.
English: By blocking the receptors to which angiotensin II normally attaches, Telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Maltese: Billi timblokka r-riċetturi li magħhom anġjotensina II normalment teħel, it-telmisartan iwaqqaf lill-ormon milli jkollu effett, u jippermetti lill-vini sabiex jitwessgħu.
English: Date of latest renewal: 19/11/2015
Maltese: Data tal-aħħar tiġdid: 19/11/2015
English: Sham sham/sham+ discontinued
Maltese: Shamsham/sham+ imwaqqaf
English: Investigations Uncommon increased gamma-glutamyltransferase activity
Maltese: Investigazzjonijiet Mhux komuni żieda fl-attività gamma-glutamyltransferase
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/325/002
Maltese: EU/1/05/325/002
English: Valeant sp. z o.o.
Maltese: Valeant sp. z o.o. sp. j.
English: (vitreous detachment)
Maltese: (stakkar tal-vitriju)
English: Fra utlandet Tlf.
Maltese: Tlf (fra udlandet):
English: Pegaptanib is metabolised by endo- and exonucleases.
Maltese: Pegaptanib jiġi metabolizzat b'endo- u exonucleases.
English: • nightmare, depression, deafness, vertigo
Maltese: • ħmar il-lejl, depressjoni, truxija, vertigo