FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/06/377/001 - 14 tablets EU/1/06/377/002 - 28 tablets EU/1/06/377/003 - 56 tablets EU/1/06/377/004 - 56 x 1 tablets EU/1/06/377/005 - 98 tablets
Maltese: EU/1/06/377/001 - 14-il pillola EU/1/06/377/002 - 28 pillola EU/1/06/377/003 - 56 pillola EU/1/06/377/004 - 56 x 1 pillola EU/1/06/377/005 - 98 pillola
English: EU/1/06/377/006 - 14 tablets EU/1/06/377/007 - 28 tablets EU/1/06/377/008 - 56 tablets EU/1/06/377/009 - 56 x 1 tablets EU/1/06/377/010 - 98 tablets
Maltese: EU/1/06/377/006 - 14-il pillola EU/1/06/377/007 - 28 pillola EU/1/06/377/008 - 56 pillola EU/1/06/377/009 - 56 x 1 pillola EU/1/06/377/010 - 98 pillola
English: EU/1/06/377/017 - 14 tablets EU/1/06/377/018 - 28 tablets EU/1/06/377/031 - 30 tablets EU/1/06/377/019 - 56 tablets EU/1/06/377/020 - 56 x 1 tablets EU/1/06/377/021 - 84 tablets EU/1/06/377/032 - 90 tablets EU/1/06/377/022 - 98 tablets
Maltese: EU/1/06/377/017 - 14-il pillola EU/1/06/377/018 - 28 pillola EU/1/06/377/031 - 30 pillola EU/1/06/377/019 - 56 pillola EU/1/06/377/020 - 56 x 1 pillola EU/1/06/377/021 - 84 pillola EU/1/06/377/032 - 90 pillola EU/1/06/377/022 - 98 pillola
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide Zentiva.
Maltese: U wkoll, tneħħija renali ta' lithium titnaqqas b'thiazides u għalhekk, ir-riskju ta' tossiċita' minn lithium tista' tiżdied b'Irbesartan Hydrochlorothiazide Zentiva.
English: EU/1/06/377/011 - 14 tablets EU/1/06/377/012 - 28 tablets EU/1/06/377/029 - 30 tablets EU/1/06/377/013 - 56 tablets EU/1/06/377/014 - 56 x 1 tablets EU/1/06/377/015 - 84 tablets EU/1/06/377/030 - 90 tablets EU/1/06/377/016 - 98 tablets
Maltese: EU/1/06/377/011 - 14-il pillola EU/1/06/377/012 - 28 pillola EU/1/06/377/029 - 30 pillola EU/1/06/377/013 - 56 pillola EU/1/06/377/014 - 56 x 1 pillola EU/1/06/377/015 - 84 pillola EU/1/06/377/030 - 90 pillola EU/1/06/377/016 - 98 pillola
English: You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan Hydrochlorothiazide Zentiva) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given anaesthetics if you have changes in your vision or pain in one or both of your eyes while taking Irbesartan Hydrochlorothiazide Zentiva.
Maltese: Int għandek tgħid ukoll lit-tabib tiegħek: jekk int qiegħed/qiegħda fuq dieta nieqsa mill-melħ jekk int qed turi sinjali bħal għatx mhux tas-soltu, ħalq xott, għejja ġenerali, ngħas, uġigħ fil-muskoli jew bugħawwieġ, dardir, rimettar jew taħbit tal-qalb mgħaġġel mhux normali li jistgħu jseħħu minħabba effett eċċessiv ta' hydrochlorothiazide (li hemm fi Irbesartan Hydrochlorothiazide Zentiva) jekk tesperjenza żieda fis-sensittività tal-ġilda għax-xemx b'sintomi ta' ħruq (bħal ħmura, ħakk, nefħa, bżieżaq) li jseħħu aktar frekwenti min-normal jekk tkun se tagħmel xi operazzjoni (kirurġija) jew tkun se tirċievi anistetiku jekk ikollok tibdil fil-viżta jew uġigħ f'waħda mill-għajnejn jew fiż-żewġ għajnejn meta tkun qed tieħu Irbesartan Hydrochlorothiazide Zentiva.
English: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 38.5 mg ta' lactose (bħala lactose monohydrate).
English: Irbesartan Hydrochlorothiazide Zentiva should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3).
Maltese: Irbesartan Hydrochlorothiazide Zentiva m'għandux jintuża f'pazjenti b'indeboliment renali sever (tneħħija talkrejatinina < 30 ml/min) (ara sezzjoni 4.3).
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Maltese: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg pilloli irbesartan/hydrochlorothiazide ISEM
English: EU/1/06/377/023 - 14 tablets EU/1/06/377/024 - 28 tablets EU/1/06/377/033 - 30 tablets EU/1/06/377/025 - 56 tablets EU/1/06/377/026 - 56 x 1 tablets EU/1/06/377/027 - 84 tablets EU/1/06/377/034 - 90 tablets EU/1/06/377/028 - 98 tablets
Maltese: EU/1/06/377/023 - 14-il pillola EU/1/06/377/024 - 28 pillola EU/1/06/377/033 - 30 pillola EU/1/06/377/025 - 56 pillola EU/1/06/377/026 - 56 x 1 pillola EU/1/06/377/027 - 84 pillola EU/1/06/377/034 - 90 pillola EU/1/06/377/028 - 98 pillola
English: Common side effects ( may affect up to 1 in 10 people): nausea/vomiting abnormal urination fatigue dizziness (including when getting up from a lying or sitting position) blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) dardir/rimettar tagħmel l-awrina mhux normali għeja sturdament (anki meta tqum minn mimdud jew minn bil-qiegħda) testijiet tad-demm jistgħu juru livelli ogħla ta' enzim li jkejjel il-funzjoni tal-muskoli u tal-qalb (creatine kinase) jew livelli għoljin ta' sustanzi li jkejlu l-funzjoni tal-kliewi (nitroġenu fl-urea tad-demm, creatinine).
English: Side effects reported since the launch of Irbesartan Hydrochlorothiazide Zentiva Some undesirable effects have been reported since marketing of Irbesartan Hydrochlorothiazide Zentiva.
Maltese: M'hemmx biżżejjed informazzjoni speċifika fuq il-kura ta' doża eċċessiva ta' Irbesartan Hydrochlorothiazide Zentiva.
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Maltese: Pilloli Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg irbesartan/hydrochlorothiazide
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets are pink, biconvex, ovalshaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Maltese: Kif jidher Irbesartan Hydrochlorothiazide Zentiva u l-kontenut tal-pakkett Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg huma roża, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2788 fuq in-naħa l-oħra.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Maltese: Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg huma fornuti fi strixxi ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force-titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Maltese: 697 pazjent intagħżlu b'mod każwali fi proporzjon ta' 2:1 jew għal irbesartan/hydrochlorothiazide 150 mg/12.5 mg jew għal irbesartan 150 mg u ġew titrati bil-forza b'mod sistematiku (qabel ma r-rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/hydrochlorothiazide 300 mg/25 mg jew irbesartan 300 mg, rispettivament.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg pilloli irbesartan/hydrochlorothiazide ISEM
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Maltese: Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg huma fornuti fi strixxi ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide Zentiva is not recommended for patients with severe renal dysfunction (creatinine clearance <30 ml/min).
Maltese: Minħabba li fih il-komponent ta' hydrochlorothiazide, Irbesartan Hydrochlorothiazide Zentiva mhux irrikmandat għall-pazjenti b'disfunzjoni renali severa (tneħħija tal-krejatinina < 30 ml/min).
English: dizziness
Maltese: Kummissjoni
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola ta' Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg fiha 150 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: Food does not affect the bioavailability of Irbesartan Hydrochlorothiazide Zentiva.
Maltese: L-ikel ma jaffettwax il-biodisponibilità ta' Irbesartan Hydrochlorothiazide Zentiva.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance <30 ml/min) Refractory hypokalaemia, hypercalcaemia
Maltese: It-tieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.4 u 4.6) Indeboliment renali sever (tneħħija tal-krejatinina < 30 ml/min) Ipokalimja rifrattorja, iperkalċimja
English: EU/1/06/377/011-016 EU/1/06/377/029-030
Maltese: EU/1/06/377/029-030
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola ta' Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg fiha 300 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: What Irbesartan Hydrochlorothiazide Zentiva contains The active substances are irbesartan and hydrochlorothiazide.
Maltese: Is-sustanzi attivi huma irbesartan u hydrochlorothiazide.
English: Potassium-sparing diuretics, potassium supplements or potassiumcontaining salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide Zentiva (see section 4.5).
Maltese: Id-dijuretiċi li ma jnaqqsux il-potassium, supplimenti tal-potassium jew sostituti li fihom il-potassium għandhom jingħataw b'attenzjoni flimkien ma' Irbesartan Hydrochlorothiazide Zentiva (ara sezzjoni 4.5).
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets.
Maltese: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg pilloli.
English: Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide Zentiva is not recommended (see section 4.4).
Maltese: Għalhekk, il-kombinazzjoni ta' lithium u Irbesartan Hydrochlorothiazide Zentiva mhiex irrikkmandata (ara sezzjoni 4.4).
English: Each tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Maltese: Hydrochlorothiazide Zentiva 300 mg/12.5 mg fiha 300 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Maltese: Kif jidher Irbesartan Hydrochlorothiazide Zentiva u l-kontenut tal-pakkett Il-pilloli Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg huma lewn il-ħawħa, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2775 fuq in-naħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets.
Maltese: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg pilloli.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Maltese: Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg huma fornuti fi strixxi ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Non-steroidal anti-inflammatory drugs: the administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients; Pressor amines (e.g. noradrenaline): the effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Maltese: Mediċini anti-infjammatorji mhux sterojdi: l-amministrazzjoni ta' mediċini anti-infjammatorji mhux sterojdi jistgħu jnaqqsu l-effetti dijuretiċi, natrijuretiċi u ta' kontra l-pressjoni għolja tat-thiazide f'xi pazjenti;
English: Warnings and precautions Talk to your doctor before taking Irbesartan Hydrochlorothiazide Zentiva and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems or have a kidney transplant if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure) if you are taking any of the following medicines used to treat high blood pressure: o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Maltese: Kellem lit-tabib tiegħek qabel tieħu Irbesartan Hydrochlorothiazide Zentiva u jekk xi waħda minn dawn tapplika għalik: jekk ikollok rimettar jew dijarea eċċessiva jekk inti tbati minn problemi tal-kliewi, jew għandek trapjant tal-kliewi jekk inti tbati minn problemi tal-qalb jekk inti tbati minn problemi tal-fwied jekk inti tbati mid-dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) jekk issofri minn aldosteroniżmu primarju (kundizzjoni relatata ma' produzzjoni għolja ta' l-ormon aldosterone, li jikkawża retenzjoni ta' sodium u, li min-naħa tiegħu, iżid il-pressjoni fid-demm) jekk inti qed tieħu xi waħda minn dawn il-mediċini li ġejjin li jintużaw għal kura ta' pressjoni tad-demm għolja. - inibitur ta' ACE (pereżempju enalapril, lisinopril, ramipril), b'mod partikulari jekk għandek problemi tal-kliewi relatati mad-dijabete. - aliskiren jekk kellek kanċer tal-ġilda jew jekk tiżviluppa leżjoni fil-ġilda mhux mistennija matul ittrattament.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Maltese: Kif jidher Irbesartan Hydrochlorothiazide Zentiva u l-kontenut tal-pakkett Il-pilloli Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg huma lewn il-ħawħa, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2776 fuq in-naħa l-oħra.
English: No dosage adjustment of Irbesartan Hydrochlorothiazide Zentiva is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Maltese: M'hemmx bżonn aġġustar fid-doża ta' Irbesartan Hydrochlorothiazide Zentiva f'pazjenti b'indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 4.3).
English: It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Maltese: Huwa mistenni li jimblokka l-azzjonijiet kollha tal-angiotensin-II medjati mir-riċettur AT1, mingħajr m'għandu x'jaqsam mal-oriġini jew rotta ta' sinteżi ta' l-angiotensin-II.
English: How to store Irbesartan Hydrochlorothiazide Zentiva Contents of the pack and other information
Maltese: Kif taħżen Irbesartan Hydrochlorothiazide Zentiva Kontenut tal-pakkett u informazzjoni oħra
English: How to take Irbesartan Hydrochlorothiazide Zentiva
Maltese: Mediċini oħra u Irbesartan Hydrochlorothiazide Zentiva
English: • Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Maltese:  Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg jista' jingħata lil pazjenti li ma jkunux qed jiġu kkontrollati b'mod suffiċjenti b'Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg.
English: Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Maltese: Indeboliment renali u trapjant tal-kliewi: meta Irbesartan Hydrochlorothiazide Zentiva jintuża f'pazjenti b'indeboliment tal-funzjoni renali, hija rrikmandata osservazzjoni perjodika tal-livelli talpotassium fis-serum, tal-krejatinina u tal-uric acid.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Maltese: Kif jidher Irbesartan Hydrochlorothiazide Zentiva u l-kontenut tal-pakkett Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg huma lewn il-ħawħa, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2875 fuq in-naħa loħra.
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Fuljett ta' tagħrif: informazzjoni għalll-utent Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg pilloli miksijin b'rita. irbesartan/hydrochlorothiazide
English: Not known: thrombocytopenia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Irbesartan Hydrochlorothiazide Zentiva should not be given to children and adolescents (under 18 years).
Maltese: Tfal u adolexxenti Irbesartan Hydrochlorothiazide Zentiva m'ghandux jingħata lil tfal u adolexxenti (taħt it-18 il-sena).
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Maltese: Kif jidher Irbesartan Hydrochlorothiazide Zentiva u l-kontenut tal-pakkett Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg huma lewn il-ħawħa, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2876 fuq in-naħa loħra.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Pilloli Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg irbesartan/hydrochlorothiazide
English: What you need to know before you take Irbesartan Hydrochlorothiazide Zentiva
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Irbesartan Hydrochlorothiazide Zentiva”
English: non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
Maltese: carbenoxolone, penicillin G sodium).
English: Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
Maltese: Effetti mhux mixtieqa, fejn il-frekwenza mhijiex magħrufa huma: uġigħ ta' ras, żarżir filwidnejn, sogħla, disturbi fit-togħma, indiġestjoni, uġigħ fil-ġogi u fil-muskoli, funzjoni tal-fwied anormali u indeboliment fil-funzjoni tal-kliewi, livell ogħla ta' potassium f'demmek u reazzjonijiet allerġiċi bħal raxx, ħorriqija, nefħa fil-wiċċ, fix-xufftejn, fil-ħalq, fl-ilsien jew fil-gerżuma.
English: Anaphylactic reaction including anaphylactic shock Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone
Maltese: Tabella 3: Reazzjonijiet avversi rapportati ma' l-użu ta' hydrochlorothiazide waħdu
English: Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, id-defiċjenza ta' Lapp lactase jew assorbiment ħażin tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: • 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 tal-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: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Fuljett ta' tagħrif: informazzjoni għalll-utent Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg pilloli miksijin b'rita. irbesartan/hydrochlorothiazide
English: 120 (60 x 2) capsules (multipack)
Maltese: 120 (60 x 2) kapsula (pakkett multiplu)
English: EMA Number
Maltese: Numru ta' l-EU
English: 3 and 5.
Maltese: 3 u 5.
English: 4866 Unterach am Attersee Austria
Maltese: 4866 Unterach am Attersee L-Awstrija
English: 21 days.
Maltese: 21 ġurnata.
English: (159 %) and 89.4 l/m
Maltese: (159 %) u 89.4 l/m
English: Adults (1,500 mg/m N=103
Maltese: Adulti (1,500 mg/m2) N=103
English: • Signs of infection.
Maltese: • Sinjali ta' infezzjoni.
English: (214 %) in adult and paediatric patients, respectively, on day 1 (n = 65 adults, n = 21 paediatric patients).
Maltese: (214 %) f'pazjenti adulti u pedjatriċi, rispettivatment, f'jum 1 (n = 65 pazjenti adulti n = 21 pazjenti pedjatriċi).
English: Carcinogenicity and mutagenicity
Maltese: Karċinoġenità u mutaġeniċità
English: 6 x 50 ml vials 250 mg/50 ml 1 x 50 ml vial 250 mg/50 ml
Maltese: 6 fjali x 50 ml 250 mg/50 ml kunjett 1 x 50 ml 250 mg/50 ml
English: (278 %) in adult and paediatric patients, respectively.
Maltese: (278 %) f'pazjenti adulti u pedjatriċi rispettivament.
English: 2.6 l/h/m
Maltese: 8 l/siegħa/m
English: Nervous system disorders Seizures (including convulsions, grand mal convulsions, status epilepticus)
Maltese: Disturbi fis-sistema nervuża Aċċessjonijiet (li jinkludu konvulżjonijiet, konvulżjonijiet grand mal,status epilepticus)
English: Survival at one year was 29 % [95 % CI: 12 %-45 %].
Maltese: Is-sopravivenza wara sena kienet ta' 29 % [95 % CI: 12 %-45 %].
English: • The active substance of Atriance is nelarabine.
Maltese: • Is-sustanza attiva ta' Atriance huwa nelarabine.
English: Children (650 mg/m N=84
Maltese: Tfal (650 mg/m2) N=84
English: Balance disorder
Maltese: Disturbi tal-bilanċ
English: (paediatrics).
Maltese: (oedema).