FrancophonIA/ELRC3.0 huggingface dataset:
English: In plaque psoriasis and psoriatic arthritis, Stelara is given as an injection under the skin.
Maltese: F'każ ta' psorijażi bil-qoxra u artrite psorjatika, Stelara jingħata bħala injezzjoni taħt il-ġilda.
English: In the second study, around 44% of those given either dose of Stelara responded, compared with around 20% of those given placebo.
Maltese: Fit-tieni studju, madwar 44% ta' dawk li ngħataw waħda miż-żewġ dożi ta' Stelara kellhom rispons, meta mqabbla ma' 20% ta' dawk li ngħataw plaċebo.
English: These cytokines are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis and Crohn's disease.
Maltese: Dawn iċ-ċitokini huma involuti fl-infjammazzjoni u proċessi oħra li huma importanti fil-psorijażi, l-artrite psorjatika u l-marda ta' Crohn. Billi timblokka l-attività tagħhom, l-ustekinumab tnaqqas l-attività tas-sistema immunitarja u s-sintomi tal-marda.
English: The side effects of the medicine were considered tolerable and manageable.
Maltese: L-effetti sekondarji tal-mediċina kienu kkunsidrati tollerabbli u maniġibbli.
English: These will focus on the safety of Stelara, particularly the risks of developing tuberculosis, other infections and cancers.
Maltese: Dawn se jiffokaw fuq is-sigurtà ta' Stelara, b'mod partikolari fuq ir-riskji ta' żvilupp tat-tuberkulożi, infezzjonijiet oħrajn u l-kanċer.
English: Eight weeks after the first infusion patients should receive 90 mg Stelara by injection under the skin.
Maltese: Tmien ġimgħat wara l-ewwel infużjoni, ilpazjenti għandhom jirċievu 90 mg Stelara permezz ta' injezzjoni taħt il-ġilda.
English: For adults with psoriatic arthritis who have not responded well to DMARDs the CHMP noted the limited treatments available and considered that Stelara would be of benefit in these patients.
Maltese: Għal pazjenti li jbatu minn artrite psorjatika li ma kellhomx rispons sew għal DMARDs, is-CHMP innota l-kuri limitati disponibbli u kkunsidra li Stelara jkun ta' benefiċċju għal dawn il-pazjenti.
English: The comparative study showed that Stelara is more effective than etanercept after 12 weeks of treatment.
Maltese: L-istudju komparattiv wera li Stelara huwa aktar effettiv minn etanersept wara 12-il ġimgħa ta' kura.
English: Stelara can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Stelara is used for.
Maltese: Il-kumpanija li tipproduċi Stelara se tipprovdi wkoll materjal edukattiv għall-persuni li jipprovdu l-kura tas-saħħa u għall-pazjenti.
English: For the full list of all side effects reported with Stelara, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati bi Stelara, ara l-fuljett ta' tagħrif.
English: How does Stelara work?
Maltese: Kif jintuża Stelara?
English: Drug substance*
Maltese: Sustanza mediċinali*
English: Tel. aus dem Ausland: +49 69 305 21 131
Maltese: aus dem Ausland: +49 69 305 21 131
English: Ambarès & Lagrave F-33565 Carbon Blanc Cedex - France
Maltese: Ambarès & Lagrave F-33565 Carbon Blanc Cedex - Franza
English: 56 x 1 tablets
Maltese: 56 x 1 pillola
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Maltese: Imblokk doppju tas-sistema tar-renin-angiotensin-aldosterone (RAAS)
English: 30 - 56 x 1 - 90 tablets
Maltese: 30 - 56 x 1 - 90 pillola
English: The mean age of patients was 52.5 years, 13% were ≥ 65 years of age, and just 2% were ≥ 75 years of age.
Maltese: L-età medja tal-pazjenti kienet ta' 52.5 sena, 13% kienu ≥ 65 sena, u 2% biss kienu ≥ 75 sena.
English: Date of first authorisation: 15 October 1998 Date of latest renewal: 15 October 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Ottubru 1998 Data tal-aħħar tiġdid: 15 ta' Ottubru 2008
English: Pharmacotherapeutic group: angiotensin-II antagonists, combinations ATC code: C09DA04.
Maltese: antagonisti ta' angiotensin-II, kombinati Kodiċi ATC: C09DA04.
English: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex France
Maltese: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex Franza
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine): the effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide;
Maltese: Rilassanti Nondepolarizing tal-muskolu skeletali (p.e. tubocurarine): l-effetti ta' rilassanti nondepolarizing tal-muskolu skeletali jistgħu jiżdiedu b'hydrochlorothiazide;
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita permezz tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: Similar effects have been very rarely reported with irbesartan so far.
Maltese: Effetti simili ġew irrapportati rarament ħafna b'irbesartan sa issa.
English: Angiotensin II Receptor Antagonists (AIIRAs)
Maltese: Antagonisti ta' Reċetturi ta' Angiotensin II (AIIRAs)
English: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France
Maltese: sanofi-aventis groupe 54, rue La Boétie, F-75008 Paris - Franza
English: Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Maltese: +32 (0)2 710 54 00 (Belgique/Belgien)
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' OR aġġustata ta' 1.29 (95 % CI: 1.23-1.35) għal BCC u 3.98 (95 % CI: 3.68-4.31) għal SCC.
English: 2112 Veresegyház - Hungary
Maltese: 2112 Veresegyház - L-Ungerija
English: Hydrochlorothiazide is a thiazide diuretic.
Maltese: Hydrochlorothiazide huwa dijuretiku thiazide.
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: NDEA Limit in ppm in API
Maltese: NDEA Limitu f'ppm fl-API
English: Following oral administration of CoAprovel, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Maltese: Wara li jingħata mill-ħalq CoAprovel il-biodisponibilità assoluta orali hija 60-80% u 50-80% għal irbesartan u hydrochlorothiazide, rispettivament.
English: SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel 37100 Tours - France
Maltese: SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel 37100 Tours - Franza
English: Metabolic and endocrine effects: thiazide therapy may impair glucose tolerance.
Maltese: Effetti metaboliċi u endokrinali: it-terapija bit-thiazide tista' tfixkel it-tolleranza tal-glucose.
English: The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Maltese: Il-metabolit maġġuri li jiċċirkola huwa irbesartan glucuronide (bejn wieħed u ieħor 6%).
English: Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports
Maltese: Tabella 1: Reazzjonijiet Avversi fi Provi Kkontrollati bi Plaċebo u Rapporti Spontaneji
English: decreases in serum potassium and sodium
Maltese: tnaqqis fil-potassium u fis-sodium tas-serum
English: NDMA Limit in ppm in API
Maltese: NDMA Limitu f'ppm fl-API
English: The study recruited 58% males.
Maltese: L-istudju kien magħmul minn 58% irġiel.
English: 14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 56 pillola 56 x 1 pillola 84 pillola 90 pillola 98 pillola
English: Gastrointestinal disorders:
Maltese: Disturbi gastro-intestinali:
English: increases in blood urea nitrogen (BUN), creatinine and creatine kinase
Maltese: żidiet fin-nitroġenu ta' l-urea tad-demm (BUN), kreatinina u creatine kinase
English: 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 56 pillola 56 x 1 pillola 98 pillola
English: 2112 Veresegyhaz Hungary
Maltese: 2112 Veresegyhaz L-Ungerija
English: respiratory distress (including pneumonitis and pulmonary oedema)
Maltese: Mhux magħrufa: diffikultà respiratorja (inkluż pulmonite u edema pulmonari)
English: 63.09 17404 Riells i Viabrea (Girona) - Spain
Maltese: Riells i Viabrea (Girona) - Spanja
English: syncope, hypotension, tachycardia, oedema
Maltese: sinkope, pressjoni baxxa, takikardija, edema
English: The total body and renal clearance are 157-176 and 3.0-3.5 ml/min, respectively.
Maltese: It-tneħħija mill-ġisem kollu u renali hija 157-176 u 3.0-3.5 ml/min, rispettivament.
English: In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials.
Maltese: Barra minn hekk, żidiet fin-nitroġenu tal-urea fid-demm (BUN) (2.3%), creatine kinase (1.7%), u kreatinina (1.1%) kienu osservati ta' spiss fil-provi.
English: There were 0.6% and 0% of patients with hypotension and 2.8% and 3.1% of patients with dizziness as adverse reactions reported in the combination and monotherapy groups, respectively.
Maltese: Kien hemm 0.6% u 0% ta' pazjenti bi pressjoni baxxa u 2.8% u 3.1% ta' pazjenti bi sturdament bħala reazzjonijiet avversi rrapportati fil-gruppi ta' kombinazzjoni u ta' monoterapija, rispettivament.
English: Please see section 2 “CoAprovel contains lactose”.
Maltese: Jekk jogħġbok ara sezzjoni 2 “CoAprovel fih lactose”.
English: Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Maltese: Kienet osservata akkumulazzjoni limitata ta' irbesartan (< 20%) fil-plażma meta ngħatat doża darba kuljum repetuta.
English: The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%).
Maltese: L-aktar reazzjonijiet avversi komuni rapportati kienu sturdament (5.6%), għeja (4.9%), tqalligħ/dardir (1.8%), u awrinazzjoni abnormali (1.4%).
English: When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Meta neċessarju, CoAprovel jista jingħata ma' prodott mediċinali ieħor kontra l-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of CoAprovel.
Maltese: It-Tabelli 2 u 3 taħt jiddeskrivu fid-dettall ir-reazzjonijiet avversi rrapportati mal-komponenti individwali ta' CoAprovel.
English: 14 - 28 - 56 - 84 - 98 tablets: Mon
Maltese: 14 - 28 - 56 - 84 - 98-il pillola:
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 ma hemm ebda data epidemijoloġika dwar ir-riskji b'Inibituri ta' Reċetturi ta' Angiotensin II (AIIRAs), jistgħu jeżistu riskji simili għal din il-klassi ta' mediċini.
English: interstitial nephritis, renal dysfunction
Maltese: Mhux magħrufa: nefrite interstizjali, disfunzjoni renali
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of CoAprovel 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 sections 4.5 and 5.1).
Maltese: Indeboliment epatiku sever, ċirrożi biljari u kolestażi L-użu fl-istess ħin ta' CoAprovel 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: Film-coated tablet.
Maltese: Kull pillola ta' CoAprovel
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-tossiċità b'irbesartan 90 mg/kg/jum, hydrochlorothiazide 90 mg/kg/jum u irbesratan/hydrochlorothiazide 10/10 mg/kg/jum.
English: Red and black ferric oxides Carnauba wax
Maltese: Ferric oxides ħomor u sofor Carnauba wax
English: The active substances are irbesartan and hydrochlorothiazide.
Maltese: Is-sustanzi attivi huma irbesartan u hydrochlorothiazide.
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 talpopolazzjoni rispettivament.
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: CoAprovel is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: CoAprovel huwa kombinazzjoni ta' antagonist ta' riċettur angiotensin-II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
English: The mean plasma half-life of hydrochlorothiazide reportedly ranges from 5-15 hours.
Maltese: Il-medja tal-half life tal-plażma ta' hydrochlorothiazide ġiet irrapportata li tvarja minn 5-15-il siegħa.
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: Sebgħa u erbgħin fil-mija (47.2%) tal-pazjenti fuq il-kombinazzjoni laħqu livell minimu ta' SeDBP < 90 mmHg meta mqabbel ma' 33.2% tal-pazjenti fuq irbesartan (p = 0.0005).
English: The mean baseline blood pressure was approximately 172/113 mmHg in each treatment group and decreases of SeSBP/SeDBP at five weeks were 30.8/24.0 mmHg and 21.1/19.3 mmHg for irbesartan/hydrochlorothiazide and irbesartan, respectively (p < 0.0001).
Maltese: Il-pressjoni tad-demm medja fil-linja bażi kienet bejn wieħed u ieħor 172/113 mmHg f'kull grupp ta' trattament u t-tnaqqis ta' SeSBP/SeDBP wara ħames ġimgħat kien 30.8/24.0 mmHg u 21.1/19.3 mmHg għal irbesartan/hydrochlorothiazide u irbesartan, rispettivament (p < 0.0001).
English: Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Maltese: Mediċini anti-infjammatorji mhux sterojdi: meta antagonisti ta' angiotensin II jingħataw simultanjament ma' mediċini anti-infjammatorji mhux sterojdi (jiġifieri inibituri COX-2 selettivi, acetylsalicylic acid (> 3 g/ġurnata) u NSAIDs mhux selettivi), jista' jkun hemm tnaqqis ta' l-effett kontra l-pressjoni għolja.
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: Mhux magħrufa: 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: 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 fil-pulmun; 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 fil-qagħda 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: 14 - 28 - 56 - 98 tablets: Mon
Maltese: 14 - 28 - 56 - 98-il pillola:
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for CoAprovel 150 mg/12.5 mg and CoAprovel 300 mg/12.5 mg, respectively.
Maltese: L-effetti millinqas għal aktar mkejla mid-dirgħajn waqt il-viżti għand it-tabib kienu 68% u 76% għal CoAprovel 150 mg/12.5 mg u CoAprovel 300 mg/12.5 mg, rispettivament.
English: Twelve percent (12%) of patients were diabetic, 34% were hyperlipidemic and the most frequent cardiovascular condition was stable angina pectoris in 3.5% of the participants.
Maltese: Tnax fil-mija (12%) tal-pazjenti kienu dijabetiċi, 34% kienu iperlipidemiċi u l-aktar kundizzjoni kardjovaskulari frekwenti kienet anġina pectoris stabbli fi 3.5% tal-parteċipanti.
English: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Maltese: Skont data disponibbli minn studji epidemjoloġiċi, ġiet osservata assoċjazzjoni kumulattiva dipendenti mid-doża bejn HCTZ u NMSC.
English: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Maltese: Skont data disponibbli minn studji epidemjoloġiċi, ġiet osservata assoċjazzjoni kumulattiva dipendenti mid-doża bejn HCTZ u NMSC (ara ukoll sezzjoni 4.4 u 5.1).
English: NDMA Limit in ng/day
Maltese: NDMA Limitu f'ng/ġurnata
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 talmediċini ċitotossiċi (p.e cyclophosphamide, methotrexate) u jżidu l-effetti majolosoppressivi tagħhom.
English: Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers.
Maltese: Irbesartan u hydrochlorothiazide (b'dożi sa 300 mg irbesartan/25 mg hydrochlorothiazide) ingħataw mingħajr periklu ma' mediċini oħra kontra l-pressjoni għolja inklużi l-imblokkaturi tal-kanali ta' calcium u mblokkaturi beta-adrenergic.
English: NDEA Limit in ng/day
Maltese: NDEA Limitu f'ng/ġurnata
English: In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Maltese: Studji in vitro jindikaw li irbesartan huwa primarjament ossidat bl-enzima cytochrome P450 CYP2C9; l-isoenzima CYP3A4 għandha effett negliġibbli.
English: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Red and yellow ferric oxides (E172)
Maltese: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Ferric oxide aħmar u isfar (E172)
English: tinnitus
Maltese: Treddigħ
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: Other medicines and CoAprovel
Maltese: Mediċini oħra u CoAprovel
English: Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Maltese: Thiazides jistgħu jnaqqsu t-tneħħija urinarja tal-calcium u jikkaġunaw li l-calcium fis-serum jogħla xi ftit f'intervalli maqsuma fl-assenza ta' mard magħruf fil-metaboliżmu tal-calcium.
English: CoAprovel is a combination of two active substances, irbesartan and hydrochlorothiazide.
Maltese: CoAprovel hu kombinazzjoni ta' żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
English: Carbamazepine: concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatraemia.
Maltese: Carbamazepine: l-użu fl-istess ħin ta' carbamazepine u hydrochlorothiazide ġie assoċjat mar-riskju ta' iponatremija sintomatika.