FrancophonIA/ELRC3.0 huggingface dataset:
English: BE-3001 Leuven Belgique/Belgien Tél/Tel: +32 (0)16 387 260
Maltese: BE-3001 Leuven Belgique/Belgien
English: Treated dogs should therefore still be kept away from bitches on heat within the first 6 weeks after initial treatment One out of 75 dogs treated with the veterinary medicinal product during clinical trials mated and tied with a bitch on heat within six months of implantation, but this did not result in pregnancy.
Maltese: Wieħed minn 75 kelb ittrattati b'dan il-prodott waqt il-provi kliniċi tgħammar u ntrabat ma' kelba sħuna fi żmien sitt xhur tal-impjantazzjoni, iżda dan ma rriżultax fi tqala.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: In ferrets: Transient moderate swelling, pruritus and erythema at the implant site were commonly observed during clinical studies.
Maltese: F'nimsa: nefħa moderata temporanja, ħakk u eritema fis-sit tal-impjant kienu osservati komunament waqt l-istudju kimiċi.
English: Each pre-loaded implanter is packaged in a sealed foil pouch, which is subsequently sterilised.
Maltese: Kull impjant li jitwaħħal minn qabel huwa ppakkajt ġewwa borża tal-fojl issiġillat, li sussegwentement huwa sterilizzat.
English: Special warnings:
Maltese: Detentur tal-awtorizzazzjoni:
English: No clinical adverse reactions other than those described in section 4.6 have been observed following simultaneous subcutaneous administration of up to 10 times the recommended dose.
Maltese: L-ebda reazzjonijiet kimiċi avversi għajr dawk deskritti f'sezzjoni 4.6 ma ġew osservati wara l-għoti taħt il-ġilda fl-istess ħin sa 10 darbiet id-doża rakkomandata.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Suprelorin 9.4 mg implant for dogs and ferrets
Maltese: Suprelorin 9.4 mg impjant għal klieb u nimsa
English: However, should it be necessary to end treatment, implants may be surgically removed by a veterinarian.
Maltese: Madankollu, jekk ikun meħtieġ li jitwaqqaf it-trattament, l-impjanti jistgħu jitneħħew kiruġikament minn veterinarju.
English: Administer one implant only, irrespective of the size of the dog (see also “Special warnings”).
Maltese: Amministra impjant wieħed biss, ikun xi jkun id-daqs tal-kelb (ara wkoll “Twissijiet Speċjali”).
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Administer one implant only, irrespective of the size of the dog (see also “Special warnings”).
Maltese: U METODU TA' AMMINISTRAZZJONI Amministra impjant wieħed biss, ikun xi jkun id-daqs tal-kelb (ara wkoll “Twissijiet Speċjali”).
English: The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after the administration of the veterinary medicinal product, has not been investigated.
Maltese: Il-ħila ta' klieb li jsiru missirijiet ta' ġriewi wara li l-livelli ta' testosterone fil-plażma jiġu lura għannormal, wara l-għoti tal-prodott mediċinali veterinarju, ma ġietx investigata.
English: 6.3 Shelf life
Maltese: 6.1 Lista ta' sustanzi
English: No clinical adverse reactions other than those described in the section “Adverse reactions” have been observed following subcutaneous administration of up to 10 times the recommended dose.
Maltese: L-ebda reazzjonijiet kliniċi avversi għajr dawk deskritti fit-taqsima “Reazzjonijiet avversi” ma ġew osservati wara l-għoti taħt il-ġilda sa 10 darbiet id-doża rakkomandata.
English: However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after 6 months, or repeated implantation, are limited.
Maltese: Madankollu, tagħrif li juri r-riversibilità kompluta tal-effetti kliniċi (tnaqqis fid-daqs testikolari, tnaqqis fil-volum tas-semen, tnaqqis fil-għadd tal-isperma) li jinkludi l-fertilità wara 6 xhur, jew impjantazzjoni rippetuta, huwa ristretta.
English: During clinical trials with Suprelorin 4.7 mg, the mean duration of testosterone suppression was 1.5 times longer among smaller size dogs (<10 kg) compared with all larger dogs.
Maltese: Waqt il-provi kliniċi b'Suprelorin 4.7 mg, iż-żmien medju tas-suppressjoni tat-testosterone kien ta' 1.5 darbiet itwal fi klieb żgħar (<10 kg) imqabblin ma' klieb akbar kollha.
English: PACKAGE LEAFLET FOR: Suprelorin 9.4 mg implant for dogs and ferrets
Maltese: Suprelorin 9.4 mg impjant għall-klieb u nimsa
English: Attach the actuator to the implanter using the Luer Lock connection.
Maltese: Waħħal l-attwatur mal-impjantatur permezz tal-konnessjoni Luer Lock.
English: 4.6 Adverse reactions (frequency and seriousness) Moderate swelling at the implant site was commonly observed for 14 days during safety/efficacy studies.
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravità)
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician, with a view to having the implant removed.
Maltese: F'każijiet rari ħafna, kien hemm interess sesswali tranżitorju miżjud, żieda fid-daqs tat-testikoli u wġigħ testikolari minnufih wara l-implantazzjoni.
English: Should a treated dog mate with a bitch between 6 weeks and 6 months after treatment, appropriate measures should be taken to rule out the risk of pregnancy.
Maltese: Jekk kelb jitgħammar ma' kelba bejn 6 ġimgħat u 6 xhur wara t-trattament, għandhom jittieħdu miżuri adattati biex jiġi eliminat ir-riskju ta' tqala.
English: Dogs and ferrets:
Maltese: Twissijiet speċjali:
English: However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after 12 months, or repeated implantation, are limited.
Maltese: Madankollu, dejta li turi r-riversibilità kompluta tal-effetti kliniċi (tnaqqis fid-daqs testikolari, tnaqqis fil-volum ta' eġakulazzjoni, tnaqqis fl-għadd tal-isperma u tnaqqis fillibido) li jinkludi l-fertilità wara sitt xhur, jew impjantazzjoni rrepetuta, huma limitati.
English: When administering the veterinary medicinal product, take care to avoid accidental self-injection by ensuring that animals are suitably restrained and the application needle is shielded until the moment of implantation.
Maltese: Għaldaqstant, dan il-prodott mediċinali veterinarju għandu jintuża bi prudenza f'nimsa rġiel intiżi għal reproduzzjoni fil-futur.
English: If loss of the implant is suspected following reimplantation, then a progressive increase will be seen in testis size and/or plasma testosterone levels.
Maltese: Jekk hemm is-suspett ta' telf tal-impjant wara rriimpjantazzjoni, ikun hemm żdieda progressiva fid-daqs tat-testikoli u/jew il-livelli ta' testosterone fil-plażma.
English: The use of the veterinary medicinal product in pre-pubertal ferrets has not been investigated.
Maltese: Ma ġiex investigat l-użu tal-prodott mediċinali veterinarju f'nimsa ta' qabel il-pubertà.
English: One implant should be administered subcutaneously between the shoulder blades of the dog.
Maltese: Amministra impjant wieħed biss, irrispettivament mid-daqs tan-nemes.
English: Cardboard carton containing either two or five individually foil wrapped implanters that have been sterilised, together with an implanting device (actuator) that is not sterilised.
Maltese: Kaxxa tal-kartuna li fiha żewġ jew ħames impjantaturi, imgewżra individwalment fil-fojl u li ġew sterilizzati, flimkien ma' strument tal-impjantazzjoni mhux sterilizzat (attwatur).
English: It has been shown in dogs that plasma deslorelin levels peak 7 to 35 days following administration of an implant containing 5 mg radiolabelled deslorelin.
Maltese: Intwera li fil-klieb il-livelli ta' deslorelin fil-plażma li jilħqu l-quċċata minn 7 sa 35 jum, wara t tqegħid ta' impjant li jkun fih 5 mg deslorelin radjutikkettat.
English: Any mating that occurs more than 6 months after the administration of the veterinary medicinal product may result in pregnancy.
Maltese: Kull tgħammir li jseħħ aktar minn 6 xhur wara t-tqegħid tal-prodott mediċinali veterinarju jista' jirriżulta fi tqala.
English: Adopted at the 6-9 March 2017 PRAC
Maltese: Adottati fil-PRAC ta' bejn is-6-9 ta' Marzu 2017
English: Fatal cases have also been reported.
Maltese: Ġew irrapportati wkoll każijiet fatali.
English: In individuals who have ingested overdoses of loperamide HCl, cardiac events such as QT interval prolongation, torsades de pointes, other serious ventricular arrhythmias, cardiac arrest and syncope have been observed (see section 4.4).
Maltese: F'individwi li jkunu ħadu dożi eċċessivi ta' loperamide HCl, ġew osservati avvenimenti kardijaċi bħal titwil tal-intervall tal-QT, torsades de pointes, arritmiji ventrikulari serji oħra, arrest kardijaku u sinkope (ara s-sezzjoni 4.4).
English: Loperamide - Serious cardiac events with high doses of loperamide from abuse and misuse (EPITT no 18339)
Maltese: 1. Loperamide - Avvenimenti kardijaċi serji b'dożi għoljin ta' loperamide minħabba abbuż u użu ħażin (EPITT nru 18339)
English: Non-clinical in vitro and in vivo evaluation of loperamide indicates no significant cardiac electrophysiological effects within its therapeutically relevant concentration range and at significant multiples of this range (up to 47-fold).
Maltese: Valutazzjoni mhux klinika in vitro u in vivo ta' loperamide ma tindika l-ebda effett elettrofiżjoloġiku kardijaku sinifikanti fi ħdan il-medda terapewtikament relevanti tal-konċentrazzjoni tiegħu u f'multipli sinifikanti ta' din il-medda (sa 47 darba).
English: Cardiac events including QT prolongation and torsades de pointes have been reported in association with overdose.
Maltese: Avvenimenti kardijaċi inkluż titwil tal-QT u torsades de pointes kienu rrapportati b'rabta ma' doża eċċessiva.
English: Nivolumab monotherapy
Maltese: Monoterapija b'nivolumab
English: Overdose
Maltese: Doża eċċessiva
English: Talk to your doctor before using OPDIVO as it may cause: Solid organ transplant rejection
Maltese: Rifjut ta' trapjant ta' organu solidu
English: Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.
Maltese: Is-sintomi jistgħu jinkludu: rata aktar mgħaġġla tal-qalb, taħbita irregolari tal-qalb, tibdil fit-taħbita tal-qalb tiegħek (dawn is-sintomi jista' jkollhom konsegwenzi potenzjalment serji u ta' periklu għallħajja), ebusija fil-muskoli, movimenti mhux koordinati, ħedla, diffikultà biex tgħaddi l-awrina, jew teħid tan-nifs bil-mod.
English: However, at extremely high concentrations associated with overdoses (see section 4.4), loperamide has cardiac electrophysiological actions consisting of inhibition of potassium (hERG) and sodium currents, and arrhythmias.
Maltese: Madankollu, f'konċentrazzjonijiet estremament għoljin assoċjati ma' dożi eċċessivi (ara s-sezzjoni 4.4), loperamide għandu azzjonijiet elettrofiżjoloġiċi kardijaċi li jikkonsistu fl-inibizzjoni tal-kurrenti tal-potassju (hERG) u tas-sodju, u arritmiji.
English: The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients.
Maltese: F'dawn il-pazjenti għandu jitqies il-benefiċċju tal-kura b'pembrolizumab kontra r-riskju tal-possibilità ta' rifjut ta' organu.
English: Some cases had a fatal outcome (see section 4.9).
Maltese: Xi każijiet kellhom eżitu fatali (ara s-sezzjoni 4.9).
English: Serious heart problems (symptoms of which include fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in <brand name>.
Maltese: Problemi kardijaċi serji (li ssintomi tagħhom jinkludu taħbita mgħaġġla jew irregolari tal-qalb) kienu rrapportati f'pazjenti li kienu ħadu ammont żejjed ta' loperamide, is-sustanza attiva f'<isem tal-prodott>.
English: The benefit of treatment with nivolumab versus the risk of possible organ rejection should be considered in these patients.
Maltese: F'dawn il-pazjenti għandu jitqies il-benefiċċju tal-kura b'nivolumab kontra r-riskju tal-possibilità ta' rifjut ta' organu.
English: High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.231.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Maltese: Użu kbir ta' HCTZ (≥50,000 mg kumulattiva) ġie assoċjat ma' ORaġġustata ta' 1.29 (95 % CI: 1.23-1.35) għal BCC u 3.98 (95 % CI: 3.68-4.31) għal SCC.
English: Following oral administration of Irbesartan Hydrochlorothiazide Zentiva, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Maltese: Wara li jingħata mill-ħalq Irbesartan Hydrochlorothiazide Zentiva il-biodisponibilità assoluta orali hija 60-80% u 50-80% għal irbesartan u hydrochlorothiazide, rispettivament.
English: Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Maltese: Cholestyramine u Colestipol resins: l-assorbiment ta' hydrochlorothiazide jiġi imfixkel fil-preżenza ta' anionic exchange resins.
English: When necessary, Irbesartan Hydrochlorothiazide Zentiva may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Meta neċessarju, Irbesartan Hydrochlorothiazide Zentiva jista jingħata ma' prodott mediċinali ieħor kontra l-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: vertigo, paraesthesia, light-headedness, restlessness
Maltese: Mhux magħrufa: vertigo, parasteżija, sturdament, irrekwitezza
English: Irbesartan Hydrochlorothiazide Zentiva is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: Irbesartan Hydrochlorothiazide Zentiva huwa kombinazzjoni ta' antagonist ta' riċettur angiotensin-II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
English: Film-coating:
Maltese: Popolazzjoni pedjatrika:
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Maltese: Żewġ provi kbar, ikkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) eżaminaw l-użu tal-kombinazzjoni ta' inibitur ta' ACE flimkien ma' imblokkatur tar-riċetturi ta' angiotensin II.
English: One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
Maltese: Studju wieħed kien jinkludi popolazzjoni li kienet tikkonsisti minn 71,533 każ ta' BCC u 8,629 każ ta' SCC imqabbla ma' 14,430,833 u għal 172,462 kontroll tal popolazzjoni rispettivament.
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan Hydrochlorothiazide Zentiva.
Maltese: It-Tabelli 2 u 3 taħt jiddeskrivu fid-dettall ir-reazzjonijiet avversi rrapportati mal-komponenti individwali ta' Irbesartan Hydrochlorothiazide Zentiva.
English: Efficacy and safety of Irbesartan Hydrochlorothiazide Zentiva as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, doubleblind, active-controlled, 8-week, parallel-arm study.
Maltese: L-effikaċja u s-sigurtà ta' Irbesartan Hydrochlorothiazide Zentiva bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b'aktar minn ċentru wieħed, b'mod każwali, double-blind, ikkontrollat b'mod attiv ta' 8 ġimgħat, parallel-arm.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, red, yellow and black ferric oxides, pregelatinized starch, carnauba wax.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, ferric oxides ħomor, sofor u suwed, lamtu preġelatinizzat, carnauba wax. .
English: Irbesartan Hydrochlorothiazide Zentiva contains lactose.
Maltese: Irbesartan Hydrochlorothiazide Zentiva fih il-lactose.
English: Irbesartan Hydrochlorothiazide Zentiva is a combination of two active substances, irbesartan and hydrochlorothiazide.
Maltese: Irbesartan Hydrochlorothiazide Zentiva hu kombinazzjoni ta' żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
English: Irbesartan Hydrochlorothiazide Zentiva is for oral use.
Maltese: Irbesartan Hydrochlorothiazide Zentiva huwa għal użu orali.
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg and Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg, respectively.
Maltese: L-effetti mill-inqas għal aktar mkejla mid-dirgħajn waqt il-viżti għand it-tabib kienu 68% u 76% għal Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg u Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg, rispettivament.
English: Please see section 2 “Irbesartan Hydrochlorothiazide Zentiva contains lactose”.
Maltese: Jekk jogħġbok ara sezzjoni 2 “Irbesartan Hydrochlorothiazide Zentiva fih lactose”.
English: How to store Irbesartan Hydrochlorothiazide Zentiva
Maltese: Kif taħżen Irbesartan Hydrochlorothiazide Zentiva
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of Irbesartan Hydrochlorothiazide Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections4.5 and 5.1).
Maltese: Indeboliment epatiku sever, ċirrożi biljari u kolestażi L-użu fl-istess ħin ta' Irbesartan Hydrochlorothiazide Zentiva ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (rata ta filtrazzjoni mill-glomeruli (GFR) < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: Lithium: the combination of lithium and Irbesartan Hydrochlorothiazide Zentiva is not recommended (see section 4.5).
Maltese: Lithium: mhux irrikmandat l-użu flimkien ta' lithium u Irbesartan Hydrochlorothiazide Zentiva (ara sezzjoni 4.5).
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide Zentiva, minimal or no effects were reported.
Maltese: Żidiet fil-livelli tal-kolesterol u tat-trigliċeridi ġew assoċjati mat-terapija dijuretika thiazide; madankollu b'doża ta' 12.5 mg ta' Irbesartan Hydrochlorothiazide Zentiva, l-effetti li ġew irrapportati kienu minimi jew xejn.
English: cough
Maltese: ACTH.
English: Irbesartan AUC and Cmax values were also somewhat greater in oldersubjects (≥ 65 years) than those of young subjects (18-40 years).
Maltese: Il-valuri ta' irbesartan AUC u Cmax kienu wkoll xi ftit iktar f'individwi akbar fl-età (≥ 65 sengħa) milli fil-pazjenti żgħar (18-40 sena).
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Il-pilloli Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg huma pprovduti f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotemia, oliguria, or rarely acute renal failure (see Section 4.5).
Maltese: Ġenerali: f'pazjenti, li għandhom it-ton vaskulari u l-funzjoni renali jiddependu l-aktar mill-attivita' tas-sistema renin-angiotensin-aldosterone (p.e. pazjenti li jbatu minn insuffiċjenza tal-qalb konġestiva jew mard renali, inkluż stenożi ta' l-arterja renali), il-kura b'impedituri ta' enzimi li jikkonvertu angiotensin jew b'riċetturi antagonisti angiotensin-II li jaffetwaw din is-sistema ġew assoċjati ma' pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza renali akuta (ara sezzjoni 4.5).
English: Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide Zentiva were:
Maltese: L-effetti sekondarji rrapportati fi studji kliniċi għal pazjenti kkurati b'Irbesartan Hydrochlorothiazide Zentiva kienu:
English: While this is not documented with Irbesartan Hydrochlorothiazide Zentiva, a similar effect should be anticipated.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'Irbesartan Hydrochlorothiazide Zentiva, effetti simili għandhom ikunu mistennija.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Il-pilloli Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg huma pprovduti f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Zentiva k.s.
Maltese: k.s.
English: The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Maltese: L-antagoniżmu selettiv tar-riċetturi tal-angiotensin-II (AT1), jirriżulta f'żidiet fil-livelli fil-plażma ta' renin u fil-livelli ta' angiotensin-II, u fi tnaqqis fil-konċentrazzjoni tal-plażma aldosterone.
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg fiha 300 mg irbesartan u 25 mg hydrochlorothiazide.
English: See also information under the heading “Do not take Irbesartan Hydrochlorothiazide Zentiva”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Irbesartan Hydrochlorothiazide Zentiva”.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Hydrochlorothiazide Zentiva” and “Warnings and precautions”).
Maltese: - Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux Irbesartan Hydrochlorothiazide Zentiva” u “Twissijiet u prekawzjonijiet”)
English: Chinoin Private Co. Ltd. Lévai u.5.
Maltese: Lévai u.5.
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg were 100%.
Maltese: Meta mkejla permezz ta' osservazzjoni tal-pressjoni ambulatorja l-effetti mill-inqas għal aktar ta' Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg kienu 100%.
English: Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Irbesartan Hydrochlorothiazide Zentiva is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Maltese: Prodotti mediċinali affettwati b'tibdil tal-potassium fis-serum: osservazzjoni perjodika tal- potassium fis-serum hija rrikmandata meta Irbesartan Hydrochlorothiazide Zentiva jiġi mogħti flimkien ma' prodotti mediċinali oħra affettwati b'disturbi tal-potassium fis-serum (p.e. digitalis glycosides, antiarritmiċi).
English: Children should not take Irbesartan Hydrochlorothiazide Zentiva Irbesartan Hydrochlorothiazide Zentiva should not be given to children under 18 years of age.
Maltese: Irbesartan Hydrochlorothiazide Zentiva ma għandux jingħata lil tfal iżgħar minn 18-il sena.