FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced coughing, compared to 68.5% of those treated with an ACE inhibitor (p <0.05).
Maltese: Fi prova klinika b'pazjenti li kienu sofrew minn sogħla xotta waqt terapija b'impeditur ACE, 19.5% tal-pazjenti tal-prova li kienu qed jirċievu valsartan u 19.0% ta' dawk li kienu qed jirċievu dijuretiċi thiazide kellhom sogħla, imqabbla ma' 68.5% ta' dawk ikkurati b'impedituri ACE (p<0.
English: Adults with mild to moderate uncomplicated essential hypertension (mean sitting diastolic blood pressure 95 and <110 mmHg) were enrolled.
Maltese: Adulti bi pressjoni għolja naturali mingħajr komplikazzjonijiet, ħafifa għal moderata (medja tal-pressjoni taddemm dijastolika waqt li jkunu bilqiegħda 95 u <110 mmHg) kienu reklutati.
English: PVC/PVDC perforated unit dose blisters.
Maltese: Folji mtaqbin tal-PVC/PVDC b'doża waħda.
English: Liver function test abnormal, including blood bilirubin increase
Maltese: Test tal-funzjoni tal-fwied mhux normali, inkluż żieda fil-bilirubin fid-demm
English: Heart failure/post-myocardial infarction
Maltese: Insuffiċjenza tal-qalb/infart postmijokardijaku
English: Dafiro 5 mg/80 mg film-coated tablets Dafiro 5 mg/160 mg film-coated tablets Dafiro 10 mg/160 mg film-coated tablets
Maltese: Dafiro 5 mg/80 mg pilloli miksija b'rita Dafiro 5 mg/160 mg pilloli miksija b'rita Dafiro 10 mg/160 mg pilloli miksija b'rita
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Maltese: Filwaqt li m'hemmx dejta epidemjoloġika kkontrollata dwar ir-riskju b'Antagonisti tarRiċetturi ta' Angiotensin II (AIIRAs), riskji jixtiebhu jistgħu jeżistu għal din il-klassi ta' prodott mediċinali.
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs attenuation of the antihypertensive effect may occur.
Maltese: Mediċini anti-infjammatorji mhux sterojdi (NSAID's), inklużi inibituri silettivi COX-2, acetylsalicylic acid (>3 g/jum), u NSAID's mhux silettivi
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanzi attivi, għad-derivati dihydropyridine, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: - Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions.
Maltese: - Reazzjonijiet severi tal-ġilda fosthom raxx qawwi fil-ġilda, ħorriqija, ħmura fil-ġilda fuq ġismek kollu, ħakk qawwi, infafet, tqaxxir u nefħa fil-ġilda, infjammazzjoni tal-membrani mukużi (Sindrome ta' Stevens Johnson, nekroliżi epidermali tossika) jew reazzjonijiet allerġiċi oħra.
English: Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Maltese: Amlodipine kien studjat f'pazjenti li jsofru minn anġina kronika stabbli, anġina vażospastika u mard ta' l-arterja koronarja dokumentat b'anġjografija.
English: The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/valsartan combination.
Maltese: Il-medja ta' l-edima periferali li seħħet, meqjusa b'mod ugwali fil-medda tad-dożi kollha kienet 5.1% bil-kombinazzjoni amlodipine/valsartan.
English: Not known Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.
Maltese: Tnaqqis fl-emoglobina, tnaqqis fl-ematocrit, newtropenja, tromboċitopenja, żieda fil-potsassju tas-serum, żieda fil-valuri tal-funzjoni tal-fwied inkluż żieda filbilirubin tas-serum, insuffiċjenza u indeboliment tal-kliewi, livell ogħla ta' kreatinina fis-serum, anġjoedima, majalġja, vaskulite, sensittività eċċessiva inkluż mard tas-serum.
English: Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2.
Maltese: Ir-riżultati ta' studju in vitro bit-tessut tal-fwied tal-bniedem jindikaw li valsartan huwa substrat tattrasportatur tat-teħid epatiku OATP1B1 u tat-trasportatur tal-effluss epatiku MRP2.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets 280 film-coated tablets 56x1 film-coated tablet (unit dose) 98x1 film-coated tablet (unit dose) 280x1 film-coated tablet (unit dose)
Maltese: 7 pilloli miksija b'rita 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 56 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita 280 pillola miksija b'rita 56xpillola 1 miksija b'rita (doża waħda) 98xpillola 1 miksija b'rita (doża waħda) 280xpillola 1 miksija b'rita(doża waħda)
English: Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Maltese: - Valsartan huwa membru ta' grupp ta' sustanzi li jissejħu “antagonisti tar-riċetturi ta'
English: Dual blockade of RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Maltese: Imblokk doppju ta' RAAS permezz tal-użu kombinat ta' inibituri ta' ACE, ARBs jew aliskiren għalhekk mhuwiex rakkomandat (ara sezzjonijiet 4.5 u 5.1).
English: Adverse reactions observed in animal studies with possible clinical relevance were as follows: Histopathological signs of inflammation of the glandular stomach was seen in male rats at an exposure of about 1.9 (valsartan) and 2.6 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Maltese: Reazzjonijiet avversi li dehru fi studji b'annimali li jistgħu jkollhom rilevanza klinika kienu kif ġej: Sinjali istopatoloġici ta' infjammazzjoni ta' l-istonku glandulari dehru f'firien maskili b'esponimenti ta' madwar 1.9 (valsartan) u 2.6 (amlodipine) -il darba d-dożi kliniċi ta' 160 mg valsartan u 10 mg amlodipine.
English: In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.
Maltese: Fi studji kliniċi ta' interazzjoni, amlodipine ma affettwax il-farmakokinetiċi ta' atorvastatin, digoxin, warfarin jew ta' ciclosporin.
English: When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered.
Maltese: Meta jkun klinikament xieraq, bidla diretta minn monoterapija għal kombinazzjoni b'doża fissa tista' tiġi konsidrata.
English: Film-coated tablet
Maltese: Żieda fil-piż
English: Dafiro 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Maltese: Dafiro 10 mg/160 mg pilloli huma ovali u sofor ċari b' “NVR” fuq naħa u “UIC” fuq in-naħa l-oħra.
English: Exanthema
Maltese: Eksantema
English: Uncommon Insomnia, mood changes (including anxiety), depression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance (including diplopia), tinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease.
Maltese: Mhux komuni Nuqqas ta' rqad, bidliet fil-burdata (fosthom ansjetà), dipressjoni, tregħid, disgewżja, sinkope, ipoestesija, disturb viżwali (fosthom diplopja), żanżin talwidnejn, pressjoni baxxa, dispneja, rinite, rimettar, dispepsja, alopeċja, purpura, tidnis tal-ġilda, iperidrosi, ħakk, exanthema, uġigħ fil-muskoli, bugħawwieġ filmuskoli, uġigħ, disturb fl-għamil tal-awrina, żieda fil-frekwenza tal-awrina, impotenza, ginekomastja, uġigħ fis-sider, astenja, żieda fil-piż, tnaqqis fil-piż.
English: A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/valsartan 10 mg/160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Maltese: Prova f'ħafna ċentri, randomizzata, double-blind, ikkontrollata bl-attiv, bi grupp parallel wasslet għal pressjoni tad-demm normali (il-pressjoni ta' bilqiegħeda l-aktar baxxa kienet <90 mmHg fl-aħħar talprova) f'pazjenti li ma kienux kontrollati sew b'amlodipine 10 mg f'78% tal-pazjenti kurati b'amlodipine/valsartan 10 mg/160 mg, imqabbla ma' 67% tal-pazjenti li baqgħu fuq amlodipine 10 mg.
English: Polyuria
Maltese: Poliurja
English: Dilated ureters were also found in the valsartan alone group (exposure 12 times the clinical dose of 160 mg valsartan).
Maltese: Uretri imwassa' instabu wkoll fil-grupp ta' valsartan waħdu (esponiment 12-il darba d-doża klinika ta 160 mg valsartan).
English: Dafiro 5 mg/80 mg film-coated tablets Dafiro 5 mg/160 mg film-coated tablets Dafiro 10 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Dafiro 5 mg/80 mg pilloli miksija b'rita Dafiro 5 mg/160 mg pilloli miksija b'rita Dafiro 10 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: Dafiro 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Maltese: Dafiro 5 mg/160 mg pilloli huma ovali u sofor skuri b' “NVR” fuq naħa u “ECE” fuq in-naħa l-oħra.
English: Pharyngolaryngeal pain Uncommon Rhinitis
Maltese: Aktar tagħrif dwar il-kombinazzjoni
English: Each tablet contains 10 mg amlodipine and 160 mg valsartan.
Maltese: Kull pillola fiha 10 mg amlodipine u 160 mg valsartan.
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 għallMediċini http://www.ema.europa.eu.
English: - Heart attack, abnormal heart beat.
Maltese: - Attakk tal-qalb, taħbita abnormali tal-qalb.
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
Maltese: F'pazjenti bil-pressjoni għolja b'funzjoni renali normali, dożi terapewtiċi ta' amlodipine wasslu għalltnaqqis fir-resistenza fil-vini renali u żieda fir-rata ta' filtrazzjoni fil-glomeruli u ċirkolazzjoni effettiva tal-plażma renali, mingħajr ma tinbidel il-frazzjoni ta' filtrazzjoni jew proteina fl-awrina.
English: Muscle spasm
Maltese: Spażmi fil-muskoli
English: Dafiro 10 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Dafiro 10 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: Coordination abnormal
Maltese: Koordinazzjoni mhux normali
English: Patients with hepatic impairment have decreased clearance of amlodipine with resulting increase of approximately 40-60% in AUC.
Maltese: Pazjenti b'indeboliment tal-fwied għandhom tneħħija ta' amlodipine imnaqqsa li tirriżulta f'żieda ta' madwar 40-60% fl-AUC.
English: Rare (may affect up to 1 in 1,000 people): Confusion.
Maltese: Rari (jista' jaffettwa mhux aktar minn persuna 1 f' 1,000):
English: All packs are available with standard blisters; the 56, 98 and 280 tablet packs are additionally available with perforated unit dose blisters.
Maltese: Il-pakketti kollha huma disponibbli b'folji standard; barra minn hekk il-pakketti b'56, 98 u 280 pillola huma disponibbli f'folji ipperforati li jinqasmu f'dożi uniċi.
English: Dafiro 5 mg/80 mg film-coated tablets amlodipine/valsartan
Maltese: Dafiro 5 mg/80 mg pilloli miksija b'rita amlodipine/valsartan
English: In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p <0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9%, respectively).
Maltese: Fi provi kliniċi fejn valsartan kien imqabbel ma' impedituri ACE, il-pazjenti kurati b'valsartan kellhom frekwenza anqas b'mod sinifikanti (p <0.05) ta' sogħla xotta minn dawk kurati b'impedituri ACE (2.6% kontra 7.9% rispettivament).
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 li jingħata ġol-vina, it-tneħħija ta' valsartan minn ġolplażma hija madwar 2 l/h u t-tneħħija renali hija 0.62 l/h (madwar 30% tat-tneħħija totali).
English: Following oral administration of Dafiro, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Maltese: Wara li Dafiro jittieħed mill-ħalq l-ogħla konċentrazzjonijiet fil-plażma ta' valsartan u amlodipine jintlaħqu fi 3 u 6-8 sigħat, rispettivament.
English: Ankle swelling
Maltese: Mhux magħrufa
English: Peripheral neuropathy, neuropathy
Maltese: Newropatija periferali, newropatija
English: Each tablet contains 5 mg amlodipine and 160 mg valsartan.
Maltese: Kull pillola fiha 5 mg amlodipine u 160 mg valsartan.
English: 70 film-coated tablets.
Maltese: 70 pillola miksija b'rita.
English: * Mostly consistent with cholestasis
Maltese: * Konsistenti l-aktar ma' kolestasi
English: Your doctor may also check your kidney function; anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone); St. John's wort; nitroglycerin and other nitrates, or other substances called “vasodilators”; medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g. ketoconazole, itraconazole); medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, talithromycin); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Maltese: John's wort; - nitroglycerin u nitrati oħra, jew sustanzi oħra magħrufin bħala “vażodilaturi”; - mediċini li jintużaw għall-HIV/AIDS (eż. ritonavir, indinavir, nelfinavir); - mediċini li jintużaw għall-kura ta' infezzjonijiet tal-moffa (eż ketoconazole, itraconazole); - mediċini li jintużaw għall-kura ta' infezzjonijiet batterjali (bħal rifampicin, erythromycin,
English: One blister contains 7, 10 or 14 film-coated tablets.
Maltese: Folja waħda fiha 7, 10 jew 14-il pillola miksija b'rita.
English: Apontis Pharma GmbH & Co. KG Tel: +49 2173 48 4949
Maltese: KG Tel: +49 2173 48 4949
English: Active-controlled trials in patients who were non-responders to monotherapy A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on valsartan 160 mg in 75% of patients treated with amlodipine/valsartan 10 mg/160 mg and 62% of patients treated with amlodipine/valsartan 5 mg/160 mg, compared to 53% of patients remaining on valsartan 160 mg.
Maltese: Provi kkontrollati b'mod attiv f'pazjenti li ma wieġbux għal monoterapija Prova f'ħafna ċentri, randomizzata, double-blind, ikkontrollata bl-attiv, bi grupp parallel wasslet għal pressjoni tad-demm normali (il-pressjoni ta' bilqiegħeda l-aktar baxxa kienet <90 mmHg fl-aħħar talprova) f'pazjenti li ma kienux kontrollati sew b'valsartan 160 mg f'75% tal-pazjenti kurati b'amlodipine/valsartan 10 mg/160 mg u 62% tal-pazjenti kurati b'amlodipine/valsartan 5 mg/160 mg, imqabbla ma' 53% tal-pazjenti li baqgħu fuq valsartan 160 mg.
English: How to store Dafiro
Maltese: X'fih Dafiro
English: Dafiro 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Dafiro 5 mg/160 mg.
Maltese: Dafiro 10 mg/160 mg jista' jingħata lill-pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b'amlodipine 10 mg jew valsartan 160 mg waħidhom jew b'Dafiro 5 mg/160 mg.
English: Posology
Maltese: Nokturja
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Maltese: Calcium gluconate mogħti minn ġol vina jista' jgħin biex ireġġa' lura l-effetti ta' l-imblukkar tal-kanali tal-calcium.
English: Each tablet contains 5 mg amlodipine and 80 mg valsartan.
Maltese: Kull pillola fiha 5 mg amlodipine u 80 mg valsartan.
English: Dafiro was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Maltese: Dafiro kien studjat ukoll fi studju kkontrollat bl-attiv ta' 130 pazjent bi pressjoni għolja bil-pressjoni dijastolika bilqiegħda medja ≥110 mmHg u <120 mmHg.
English: Dafiro 5 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Dafiro 5 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: Dizziness
Maltese: Disgewżja
English: Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Maltese: Inibituri tat-trasportatur tat-teħid (rifampicin, ciclosporin) jew trasportatur tal-effluss (ritonavir)
English: Intrahepatic cholestasis, jaundice
Maltese: Kolestażi ġol-fwied, suffejra
English: Mutagenicity studies revealed no drug related effects at either the gene or chromosome levels.
Maltese: Studji dwar il-mutaġeniċità ma żvelawx effetti relatati mal-mediċina fil-livelli tal-ġeni jew talkromosomi.
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 jidhirx li għandu effett parzjali ta' agonist tar-riċettur AT1 u għandu affinità ħafna akbar (b'madwar 20,000 darba) għar-riċettur AT1 milli għar-riċettur AT2.
English: Common Somnolence, dizziness, palpitations, abdominal pain, nausea, ankle swelling.
Maltese: Ngħas, sturdament, palpitazzjonijiet, uġigħ addominali, dardir, nefħa fl-għekiesi.
English: EU/1/06/371/034 280 film-coated tablets (4x70) EU/1/06/371/037 280 film-coated tablets (20x14)
Maltese: EU/1/06/371/034 280 pillola miksija b'rita (4x70)
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Sakemm kura b'AIIRA kontinwata hija ikkunsidrata essenzjali, pazjenti li qed jippjanaw għal tqala għandhom jinqalbu għal kura alternattiva kontra l-pressjoni għolja li għandha profil ta' sigurtà stabbilit qћall-uzu fit-tqala.
English: Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure.
Maltese: L-użu fl-istess ħin ta' amlodipine ma' inibituri ta' CYP3A4 b'saħħithom jew moderati (inibituri talprotease, antifungali tal-azole, makrolidi bħal erythromycin jew clarithromycin, verapamil jew diltiazem) jista' jagħti lok għal żieda sinifikanti fl-espożizzjoni għal amlodipine.
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/m basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Maltese: Fil-firien dawn id-dożi (200 sa 600 mg/kg/kuljum) huma madwar 6 u 18-il darba ogħla mid-doża massima rrakkomandata fil-bniedem fuq bażi ta' mg/m (kalkulazzjonijet jassumu doża orali ta' 320 mg/kuljum u pazjent ta' 60-kg).
English: Dafiro 5 mg/80 mg film-coated tablets
Maltese: Dafiro 5 mg/80 mg pilloli miksija b'rita
English: Valsartan has been studied in patients with post myocardial infarction and heart failure.
Maltese: Valsartan kien studjat f'pazjenti li kienu sofrew minn infart mijokardijaku u insuffiċjenza tal-qalb.
English: EU/1/06/371/017 7 film-coated tablets EU/1/06/371/018 14 film-coated tablets EU/1/06/371/019 28 film-coated tablets EU/1/06/371/020 30 film-coated tablets EU/1/06/371/021 56 film-coated tablets EU/1/06/371/022 90 film-coated tablets EU/1/06/371/023 98 film-coated tablets EU/1/06/371/024 280 film-coated tablets EU/1/06/371/031 56x1 film-coated tablet (unit dose) EU/1/06/371/032 98x1 film-coated tablet (unit dose) EU/1/06/371/033 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/371/017 7 pilloli miksija b'rita EU/1/06/371/018 14-il pillola miksija b'rita EU/1/06/371/019 28 pillola miksija b'rita EU/1/06/371/020 30 pillola miksija b'rita EU/1/06/371/021 56 pillola miksija b'rita EU/1/06/371/022 90 pillola miksija b'rita EU/1/06/371/023 98 pillola miksija b'rita EU/1/06/371/024 280 pillola miksija b'rita EU/1/06/371/031 56xpillola 1 miksija b'rita (doża b'waħda) EU/1/06/371/032 98xpillola 1 miksija b'rita (doża b'waħda) EU/1/06/371/033 280xpillola 1 miksija b'rita (doża b'waħda)
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Maltese: Espożizzjoni għall-kura ta' AIIRA fit-tieni u it-tielet trimestri huwa magħruf li jinduċi tossiċità talfetu uman (funzjoni renali mnaqqsa, oligoidramnios, ittardjar ta' l-ossifikazzjoni tal-kranju) u tossiċità fit-trabi wara it-twelid (indeboliment renali, pressjoni baxxa, iperkalemia)
English: EU/1/06/371/036 280 film-coated tablets (4x70) EU/1/06/371/039 280 film-coated tablets (20x14)
Maltese: EU/1/06/371/039 280 pillola miksija b'rita (20x14)
English: Paediatric population (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Maltese: Popolazzjoni pedjatrika (età taħt it-18-il sena) M'hemmx tagħrif farmakokinetiku fil-popolazzjoni pedjatrika.
English: Hyponatraemia
Maltese: Iperkalċimija
English: EU/1/06/371/035 280 film-coated tablets (4x70) EU/1/06/371/038 280 film-coated tablets (20x14)
Maltese: EU/1/06/371/038 280 pillola miksija b'rita (20x14)
English: In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised blood urea nitrogen, and renal tubular hyperplasia and basophilia in males).
Maltese: Fi studji mhux kliniċi dwar is-sigurtà, dożi għolja ta' valsartan (200 sa 600 mg/kg piż tal-ġisem) ikkawżaw tnaqqis fil-parametri ta' ċelluli ħomor tad-demm fil-firien (eritroċiti, emoglobina, ematokrita) u evidenza ta' bidliet fl-emodinamika renali (urea nitrogen fid-demm kemmxejn miżjuda, u iperplasija tubulari renali u bażofilja fl-irġiel).