FrancophonIA/ELRC3.0 huggingface dataset:
English: Also, 79% of patients given Kyntheum had clear or nearly clear skin after 12 weeks, compared with 3% of patients given placebo and 70% of patients given ustekinumab.
Maltese: Barra minn hekk, 79 % tal-pazjenti li ngħataw Kyntheum kellhom ukoll ġilda ċara jew kważi ċara wara 12-il ġimgħa, meta mqabbla mat-3 % tal-pazjenti li ngħataw il-plaċebo u mas-70 % tal-pazjenti li ngħataw ustekinumab.
English: The most common side effects with Kyntheum (which may affect more than 1 in 100 people) are joint pain, headache, tiredness, diarrhoea and oropharyngeal pain (pain in the mouth and throat).
Maltese: L-effetti sekondarji l-aktar komuni b'Kyntheum (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 100) huma uġigħ fil-ġogi, uġigħ ta' ras, għeja, dijarea u uġigħ orofarinġeali (uġigħ fil-ħalq u lgriżmejn).
English: Kyntheum has been shown to be effective at treating plaque psoriasis in 3 main studies involving over 4,300 patients who required systemic treatment.
Maltese: Kyntheum intwera li huwa effettiv fil-kura tal-psorijażi tal-plakka fi 3 studji ewlenin li jinvolvu aktar minn 4,300 pazjent li kienu jirrikjedu kura sistemika.
English: Although there is no evidence of a link to the medicine, the decision to start Kyntheum in patients who have had suicidal behaviour in the past or suffered from depression or anxiety should be made after carefully looking at all the risks and benefits for that patient.
Maltese: Minkejja li m'hemmx evidenza ta' rabta mal-mediċina, id-deċiżjoni li jinbeda Kyntheum f'pazjenti li kellhom mġiba suwiċidali fil-passat jew li sofrew minn dipressjoni jew anzjentà għandha ssir wara li tkun ingħatat ħarsa bir-reqqa lejn irriskji u l-benefiċċji kollha għal dak il-pazjent.
English: Kyntheum must not be given to patients who have potentially serious infections such as tuberculosis and to patients with active Crohn's disease (an inflammatory disease affecting the gut).
Maltese: Kyntheum m'għandux jingħata lil pazjenti li għandhom infezzjonijiet potenzjalment serji bħal tuberkulożu u lil pazjenti bil-marda ta' Crohn attiva (marda infjammatorja li taffettwa l-musrana).
English: There have been some reports of suicidal behaviour in patients taking the medicine.
Maltese: Kien hemm xi rapporti ta' mġiba suwiċidali f'pazjenti li jieħdu l-mediċina.
English: How is Kyntheum used?
Maltese: Kif jaħdem Kyntheum?
English: For the full list of all side effects and restrictions with Kyntheum, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Kyntheum, ara l-fuljett ta' tagħrif.
English: It is used in adults whose disease is moderate to severe and who require systemic treatment (treatment with medicines given by mouth or by injection).
Maltese: Dan jintuża f'adulti li l-marda tagħhom hija minn moderata sa severa u li jkunu jeħtieġu kura sistemika (kura b'mediċini mogħtija oralment jew b'injezzjoni).
English: The full EPAR for Kisplyx 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: Kisplyx is available as capsules (4 mg and 10 mg).
Maltese: Kisplyx jiġi bħala kapsuli (4 mg u 10 mg).
English: The active substance in Kisplyx, lenvatinib, is a ‘tyrosine-kinase inhibitor'.
Maltese: Is-sustanza attiva f'Kisplyx, il-lenvatinib, hija "inibitur tat-tirosina kinażi".
English: The most common side effects with Kisplyx, when used in combination with everolimus or alone and which may affect more than 3 in 10 people, are diarrhoea, high blood pressure, tiredness, loss of appetite and weight, vomiting, nausea (feeling sick), proteinuria (protein in the urine), stomatitis (inflammation of the lining of the mouth), headache, dysphonia (speech disturbances), palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), peripheral oedema (swelling, especially of the ankles and feet) and hypercholesterolemia (high levels of cholesterol [type of fat] in the blood).
Maltese: L-effetti sekondarji l-aktar komuni b'Kisplyx, meta jintuża f'kombinazzjoni ma' everolimus jew waħdu u li jistgħu jaffettwaw aktar minn 3 persuni minn kull 10, huma dijarea, pressjoni għolja tad-demm, għeja, tnaqqis fl-aptit u fil-piż, rimettar, nawżja (dardir), proteinurja (proteina fl-awrina), stomatite (infjammazzjoni tal-kisja tal-ħalq), uġigħ ta' ras, disfonja (disturbi fid-diskors), sindromu taleritrodisasteżija palmar-plantar (sindromu tal-idejn u s-saqajn, li jinvolvi raxx u tnemnim fil-pali talidejn u l-qigħan tas-saqajn), edema periferali (nefħa, speċjalment tal-għekiesi u s-saqajn) u iperkolesterolemija (livelli għoljin ta' kolesterol [tip ta' xaħam] fid-demm).
English: This is a summary of the European public assessment report (EPAR) for Kisplyx.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kisplyx.
English: The recommended dose is 18 mg (made up of one 10 mg capsule and two 4 mg capsules) once a day at the same time each day in combination with 5 mg of everolimus once a day.
Maltese: Id-doża rakkomandata hija 18 mg (magħmula minn kapsula waħda ta' 10 mg u żewġ kapsuli ta' 4 mg) darba kuljum fl-istess ħin tal-jum flimkien ma' 5 mg ta' everolimus darba kuljum.
English: Why is Kisplyx approved?
Maltese: Għaliex ġie approvat Kisplyx?
English: Kisplyx contains the active substance lenvatinib.
Maltese: Kisplyx fih is-sustanza attiva lenvatinib.
English: Patients who took the combination of Kisplyx and everolimus lived for an average of 14.6 months without their disease getting worse, compared with 7.4 months for the patients who took Kisplyx alone and 5.5 months for the patients who took everolimus alone.
Maltese: Il-pazjenti li ħadu l-kombinazzjoni ta' Kisplyx u everolimus għexu għal medja ta' 14.6 xhur mingħajr ma l-marda tagħhom marret għall-agħar, imqabbla ma' 7.4 xhur għall-pazjenti li ħadu Kisplyx waħdu u l-5.5 xhur għall-pazjenti li ħadu everolimus waħdu.
English: Kisplyx is a cancer medicine used to treat adults with advanced renal cell carcinoma (a type of kidney cancer) who have been previously treated with a type of cancer medicine called a ‘vascular endothelial growth factor (VEGF) inhibitor'.
Maltese: Kisplyx huwa mediċina kontra l-kanċer użat biex jikkura adulti b'karċinoma avvanzata fiċ-ċelloli renali (tip ta' kanċer fil-kliewi) li kienu ġew ikkurati preċedentament b'tip ta' mediċina kontra l-kanċer imsejħa "inibitur tal-fattur tat-tkabbir vaskulari endoteljali (VEGF, vascular endothelial growth factor)".
English: The most important serious side effects are kidney failure and reduced kidney function; problems with the heart and circulation such as heart failure and blood clots in the arteries leading to stroke or heart attack; bleeding in the brain or bleeding of a tumour within the skull; a syndrome known as ‘posterior reversible encephalopathy syndrome' characterised by headache, confusion, fits and loss of vision; and liver failure.
Maltese: L-effetti sekondarji serji l-aktar importanti huma insuffiċjenza tal-kliewi u funzjoni indebolita tal-kliewi; problemi bil-qalb u biċ-ċirkolazzjoni bħal insuffiċjenza tal-qalb u emboli tad-demm fl-arterji li jwasslu għal puplesija jew attakk tal-qalb; fsada fil-moħħ jew fsada ta' tumur fil-kranju; sindrome magħrufa bħala "sindrome tal-enċefalopatija riversibbli posterjuri" kkaratterizzata minn uġigħ ta' ras, konfużjoni, aċċessjonijiet u t-telf tal-vista; u insuffiċjenza tal-fwied.
English: Other information about Kisplyx
Maltese: Informazzjoni oħra dwar Kisplyx:
English: Kisplyx has been investigated in one main study involving 153 adults with advanced renal cell carcinoma that had got worse despite treatment with a VEGF inhibitor.
Maltese: Kisplyx ġie investigat fi studju wieħed ewlieni li involva 153 adult b'karċinoma avvanzata fiċ-ċelloli renali li marret għall-agħar minkejja l-kura b'inibitur VEGF.
English: Kisplyx is used together with another cancer medicine called everolimus.
Maltese: Kisplyx jintuża flimkien ma' mediċina oħra kontra l-kanċer imsejħa everolimus.
English: For the list of all side effects reported with everolimus, see the package leaflet of the medicine containing everolimus.
Maltese: Għal-lista tal-effetti sekondarji kollha rrappurtati b'everolimus, ara l-fuljett ta' tagħrif tal-mediċina li fiha everolimus.
English: These enzymes can be found in certain receptors (such as VEGF, FGFR, PDGF, KIT and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels.
Maltese: Dawn l-enzimi jistgħu jinstabu f'ċerti riċetturi (bħal riċetturi VEGF, FGFR, PDGF, KIT u RET) f'ċelloli tal-kanċer, fejn dawn jattivaw bosta proċessi inkluż diviżjoni ta' ċelloli u t-tkabbir ta' vini u arterji ġodda.
English: What are the risks associated with Kisplyx?
Maltese: X'inhuma r-riskji assoċjati ma' Kisplyx?
English: This means that it blocks the activity of enzymes known as tyrosine kinases.
Maltese: Dan ifisser li timblokka lattività ta' enzimi magħrufin bħala tirożina kinażi.
English: The study compared the combination of Kisplyx and everolimus with Kisplyx or everolimus alone.
Maltese: L-istudju qabbel il-kombinazzjoni ta' Kisplyx u everolimus ma' Kisplyx jew everolimus waħedhom.
English: The safety of Kisplyx used in combination with everolimus is similar to that of these medicines when used individually, and side effects are considered manageable.
Maltese: Is-sigurtà ta' Kisplyx użat f'kombinazzjoni ma' everolimus hija simili għal dik ta' dawn il-mediċini meta jintuża b'mod individwali, u l-effetti sekondarji huma kkunsidrati maniġġevoli.
English: For the full list of all side effects reported with Kisplyx, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Kisplyx, ara l-fuljett ta' tagħrif.
English: How is Kisplyx used?
Maltese: Kif jaħdem Kisplyx?
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 January 2007
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 19 ta' Jannar 2007
English: respiratory distress (including pneumonitis and pulmonary oedema)
Maltese: diffikultà respiratorja (inkluż pulmonite u edema pulmonari)
English: Pharmacotherapeutic group: angiotensin-II antagonists, combinations ATC code: C09DA04.
Maltese: antagonisti ta' angiotensin-II, kombinati Kodiċi ATC C09DA04.
English: arthralgia, myalgia
Maltese: artralġija, mijalġija
English: Newcastle Upon Tyne Tyne & Wear NE3 3TT United Kingdom
Maltese: Newcastle Upon Tyne Tyne & Wear NE3 3TT Ir-Renju Unit
English: interstitial nephritis, renal dysfunction
Maltese: nefrite interstizjali, disfunzjoni renali
English: Hydrochlorothiazide is 68% protein-bound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Maltese: Hydrochlrothiazide jeħel mal-proteini tal-plażma bi 68%, u l-volum ta' distibuzzjoni apparenti huwa 0.83 - 1.14 l/kg.
English: Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports* Common:
Maltese: Tabella 1: Reazzjonijiet Avversi fi Provi Kkontrollati bi Plaċebo u Rapporti Spontaneji* Komuni:
English: 14 tablets 28 tablets 56 tablets 56 x 1 tablets 84 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 56 pillola 56 x 1 pillola 84 pillola 98 pillola
English: vertigo, paraesthesia, light-headedness, restlessness
Maltese: Vertigo, parasteżija, sturdament, irrekwitezza
English: jaundice (intrahepatic cholestatic jaundice)
Maltese: Mhux suffejra (suffejra intraepatika kolestatika)
English: Musculoskeletal and connective tissue disorders:
Maltese: Disturbi muskoluskeltrali u tal-connective tissue:
English: orthostatic dizziness
Maltese: sturdament ortostatiku
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: They may cause a decrease in placental perfusion, foetal electrolyte disturbances and possibly other reactions that have occurred in the adults.
Maltese: Jistgħu iġibu nuqqas filperfużjoni tal-plaċenta, disturbi fl-elettroliti tal-fetu u possibilment reazzjonijiet oħra li ġraw fl-adulti.
English: FOR
Maltese: JIS
English: Following oral administration of Irbesartan Hydrochlorothiazide BMS, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Maltese: Wara li jingħata mill-ħalq Irbesartan Hydrochlorothiazide BMS il-biodisponibilità assoluta orali hija 60 - 80% u 50 - 80% għal irbesartan u hydrochlorothiazide, rispettivament.
English: The following changes, observed in rats and macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, were also seen with one of the two medicinal products alone and/or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed): kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system; slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit); stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
Maltese: It-tibdiliet li ġejjin, osservati f'firien u f'makakki li rċevew il-kombinazzjoni ta' irbesartan/ hydrochlorothiazide f'dożi ta' 10/10 u 90/90 mg/kg/jum, dehru wkoll b'wieħed minn dawn iż-żewġ mediċini waħidhom u/jew kienu sekondarji għal tnaqqis tal-pressjoni (ma ġewx osservati interazzjonijiet tossikoloġiċi sinifikanti): tibdil fil-kliewi, ikkaratterizzat minn żidiet ħfief fl-urea fis-serum u tal-krejatinina, u iperplażja/ ipertrofija ta' l-apparat jukstaglomerulari, li huma konsegwenza diretta ta' l-interazzjoni ta' irbesartan mas-sistema renin-angiotensin; tnaqqis żgħir fil-parametri ta' l-eritroċiti (eritroċiti, emoglobina, ematokrit); telf ta' kulur fl-istonku, ulċeri, nekrożi fokali tal-mukoża gastrika ġew osservati fi ftit firien fi studju ta' 6 xhur fuq it-tossiċita` b'irbesartan 90 mg/kg/jum, hydrochlorothiazide 90 mg/kg/jum u irbesratan/hydrochlorothiazide 10/10 mg/kg/jum.
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan Hydrochlorothiazide BMS.
Maltese: It-Tabelli 2 u 3 taħt jiddeskrivu fid-dettall ir-reazzjonijiet avversi rrapportati mal-komponenti individwali ta' Irbesartan Hydrochlorothiazide BMS.
English: The terminal elimination half-life of irbesartan is 11-15 hours.
Maltese: Il-half-life ta' l-eliminazzjoni terminali ta' irbesartan hija 11 - 15-il siegħa.
English: Irbesartan/hydrochlorothiazide combination:
Maltese: L-għoti ta' irbesartan/hydrochlorothiazide flimkien:
English: Side effects associated with hydrochlorothiazide alone Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Maltese: Effetti sekondarji assoċjati ma' hydrochlorothiazide waħdu Nuqqas ta' aptit; irritazzjoni ta' l-istonku; bugħawwiġ fl-istonku; stitikezza, suffejra (sfurija tal-ġilda u/jew ta' l-abjad ta' l-għajnejn); infjammazzjoni tal-frixa kkaratterizzata b'uġigħ sever fil-parti ta' fuq ta' l-istonku, spiss b'dardir u rimettar; disturbi fl-irqad; dipressjoni; vista mċajpra; nuqqas ta' ċelloli bojod tad-demm, li jistgħu jirriżultaw f'infezzjonijiet frekwenti, deni; tnaqqis fin-numru ta' plejtlits (ċellola tad-demm essenzjali għall-għaqid tad-demm), numru mnaqqas taċ-ċelloli tad-demm ħomor (anemija) ikkaratterizzat minn għejja, uġigħ ta' ras, qtugħ ta' nifs waqt eżerċizzju, sturdament u dehra pallida; mard fil-kliewi; problemi fil-pulmun inkluż pulmonite jew akkumulazzjoni ta' fluwidu filpulmun; sensittività miżjuda tal-ġilda fix-xemx; infjammazzjoni tal-vażi tad-demm; marda tal-ġilda kkaratterizzata mit-tqaxxir tal-ġilda fuq il-ġisem kollu; lupus erythematosus tal-ġilda, li hija identifikata minn raxx li jista' jidher fuq il-wiċċ, għonq u qorrija; reazzjonijiet allerġiċi; dgħjufija u spażmu tal-muskoli; rata tat-taħbit tal-qalb mibdula; tnaqqis fil-pressjoni tad-demm wara bidla filqagħda tal-ġisem; nefħa tal-glandoli tal-bżieq; livelli ta' zokkor għoljin fid-demm; zokkor fl-awrina; żidiet f'xi tipi ta' xaħam fid-demm; livelli ta' aċidu uriku fid-demm għoljin, li jista' jikkawża gotta.
English: * Frequency for adverse reactions detected by spontaneous reports is described as “not known”
Maltese: * Il-frekwenza għal reazzjonijiet avversi mikxufin minn rapporti spontaneji hija deskritta bħala “mhux magħrufa”
English: transient blurred vision, xanthopsia
Maltese: vista mċajpra li tgħaddi, xanthopsia
English: Irbesartan Hydrochlorothiazide BMS is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: Irbesartan Hydrochlorothiazide BMS huwa kombinazzjoni ta' antagonist ta' riċettur angiotensin-II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
English: Thiazides may reduce the renal excretion of cytotoxic medicinal products (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Maltese: Thiazides jistgħu jnaqqsu l-eskrezzjoni renali tal-mediċini ċitotossiċi (p.e cyclophosphamide, methotrexate) u jżidu l-effetti majolosoppressivi tagħhom.
English: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
Maltese: reazzjonijiet anafilattiċi, nekroliżi epidermali tossika, anġite nekrotizzanti (vaskulite, vaskulite kutanja), reazzjonijiet tal-ġilda bħal lupus eritematożi, riattivazzjoni tal-lupus eritematożi kutanja, reazzjonijiet fotosensittivi, raxx, urtikarja
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials in which 898 hypertensive patients received various doses (range: 37.5 mg/6.25 mg to 300 mg/25 mg irbesartan/hydrochlorothiazide).
Maltese: It-Tabella 1 tagħti r-reazzjonijiet avversi osservati minn rapportaġġ spontanju u fi provi kkontrollati bi plaċebo li fihom 898 pazjent bi pressjoni għolja rċievew għadd ta' dożi (medda: 37.5 mg/6.25 mg sa 300 mg/25 mg irbesartan/hydrochlorothiazide) u reazzjonijiet avversi minn rapportaġġ spontanju.
English: Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
Maltese: Erbgħa u sebgħin fil-mija (47.2%) talpazjenti fuq il-kombinazzjoni laħqu livell minimu ta' SeDBP < 90 mmHg meta mqabbel ma' 33.2% tal-pazjenti fuq irbesartan (p = 0.0005).
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini (EMEA): http://www.emea.europa.eu/
English: Irbesartan: there was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Maltese: Irbesartan: ma kienx hemm evidenza ta' anormalità sistemika jew tossiċità li tattakka l-organu immirat b'dożi klinikament rilevanti.
English: dizziness
Maltese: Dożaġġ
English: aplastic anaemia, bone marrow depression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Maltese: anemija aplastika, dipressjoni talmudullun ta' l-għadam, newtropenja/agranuloċitożi, anemija emolitika, lewkopenja, tromboċitopenja
English: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Maltese: pankrejatite, anoressja, dijarea, stitikezza, irritazzjoni fl-istonku, sijaladenite, nuqqas ta' aptit
English: INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg
English: Irbesartan Hydrochlorothiazide BMS is for oral use.
Maltese: Irbesartan Hydrochlorothiazide BMS huwa għal użu orali.
English: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Maltese: ipokalemija u l-iponatremja, ara sezzjoni 4.4), iperuriċemija glikożurja, ipergliċemija, żieda fil-kolesterol u trigliċeridi
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: The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
Maltese: L-effetti ta' indutturi ta' CYP2C9 bħal rifampicin fuq ilfarmakokinetika ta' irbesartan ma ġewx evalwati.
English: Cartons of 56 x 1 tablets; 7 blister cards of 8 x 1 tablets each in PVC/PVDC/Aluminium perforated unit dose blisters.
Maltese: Pakketti ta' 56 x 1 pillola ; 7 strixxi ta' 8 x 1 pillola kull waħda f'folji tal-PVC/PVDC/Aluminju perforati ta' doża waħda.
English: Furthermore, irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Maltese: Iktar minn hekk irbesartan ikkaġuna iperplasja/ipertrofija taċ-ċelluli jukstaglomerulari (f'firien b'≥ 90 mg/kg/jum, f'makakki b' ≥ 10 mg/kg/jum).
English: Efficacy and safety of Irbesartan Hydrochlorothiazide BMS as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double-blind, activecontrolled, 8-week, parallel-arm study.
Maltese: L-effikaċja u s-sigurtà ta' Irbesartan Hydrochlorothiazide BMS 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.