FrancophonIA/ELRC3.0 huggingface dataset:
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis.
Maltese: Doża eċċessiva ta' hydrochlorothiazide hija assoċjata ma' tnaqqis fl-elettroliti (ipokalemija, ipokloremija, iponatremija) u deidrazzjoni minħabba dijureżi eċċessiva.
English: Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years).
Maltese: Irbesartan/Hydrochlorothiazide Teva m'ghandux jingħata lil tfal u adolexxenti (taħt it-18 il-sena).
English: Concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatraemia.
Maltese: L-użu fl-istess ħin ta' carbamazepine u hydrochlorothiazide ġie assoċjat mar-riskju ta' iponatremija sintomatika.
English: For Irbesartan/Hydrochlorothiazide Teva packaged in white opaque PVC-PVdC - aluminium blisters: Do not store above 30°C.
Maltese: Għal Irbesartan/Hydrochlorothiazide Teva ippakkjat f'folji opaki bojod tal-PVC-PVdC - aluminju:
English: While hydrochlorothiazide is a sulfonamide, only isolated cases of acute angle-closure glaucoma have been reported so far with hydrochlorothiazide.
Maltese: Filwaqt li hydrochlorothiazide huwa sulfonamide, każijiet iżolati biss ta' glawkoma akuta ta' għeluq tal-angolu ġew irrapportati s'issa b'hydrochlorothiazide.
English: 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
Maltese: • 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: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull pillola miksija b'rita, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: 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. ONTARGET kien studju li twettaq f'pazjenti bi storja medika ta' mard kardjovaskulari jew ċerebrovaskulari, jew dijabete mellitus tip 2 akkumpanjat minn evidenza ta' ħsara fl-organu aħħari. VA NEPHRON-D kien studju li twettaq f'pazjenti b'dijabete mellitus tip 2 u nefropatija dijabetika.
English: Specifically, CHMP considered that NDMA and NDEA limits should be as low as technically possible.
Maltese: Speċifikament, is-CHMP ikkunsidra li l-limiti ta' NDMA u NDEA għandhom ikunu baxxi kemm jista' jkun teknikament possibbli.
English: Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Maltese: Wara l-għoti mill-ħalq jew minn ġol-vina ta' 14C irbesartan, 80-85 % tar-radjuattività li tiċċirkola fil-plażma hi attribwita għal irbesartan mhux mibdul.
English: Each film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide
Maltese: Kull pillola miksija b'rita fiha 150 mg irbesartan u 12.5 mg hydrochlorothiazide
English: Non-steroidal anti-inflammatory drugs
Maltese: Mediċini anti-infjammatorji mhux sterojdi
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).
Maltese: Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux Irbesartan/Hydrochlorothiazide Teva” u “Twissijiet u prekawzjonijiet”)
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets Pink to dark pink, film-coated capsule shaped tablet.
Maltese: Il-pilloli miksija b'rita ta' Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg huma roża ċari għal roża, miksija b'rita, pilloli f'għamla ta' kapsula.
English: Considerations on monitoring of exposed patients
Maltese: Konsiderazzjonijiet dwar il-monitoraġġ ta' pazjenti esposti
English: Each film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide
Maltese: Kull pillola miksija b'rita fiha 300 mg irbesartan u 12.5 mg hydrochlorothiazide
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Danmark
Maltese: Finnland
English: Do not use this medicine after the expiry date that is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-kartuna u fuq il-folja wara EXP.
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist.
Maltese: Irbesartan huwa antagonista qawwi, attiv mill-ħalq, antagonista selettiv tarriċettur angiotensin-II (tip
English: Side effects associated with hydrochlorothiazide alone are:
Maltese: Effetti sekondarji addizzjonali assoċjati ma' hydrochlorothiazide waħdu huma:
English: Irbesartan/hydrochlorothiazide combination
Maltese: Il-kombinazzjoni ta' irbesartan/hydrochlorothiazide
English: The other side of the tablet debossed with the number "7469".
Maltese: In-naħa l-oħra tal-pillola hija intaljata bil-kodiċi "7469".
English: Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg was observed; the mechanism for this is unknown.
Maltese: Ġiet osservata żieda mhux proporzjonali, fl-assorbiment mill-ħalq meta tingħata doża iktar minn 600 mg; dan il-mekkaniżmu għadu mhux magħruf.
English: These findings were also observed with lower doses of this other angiotensin-II antagonist when given in combination with hydrochlorothiazide.
Maltese: Xi effetti mhux mixtieqa ġew rapportati minn meta tqegħdet fis-suq il-kombinazzjoni ta' irbesartan u hydrochlorothiazide.
English: Whereas
Maltese: Teva
English: Blood and lymphatic system disorders:
Maltese: Disturbi tad-demm u tas-sistema limfatika:
English: Each film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide
Maltese: Mhux rakkomandati dożi ogħla minn 300 mg irbesartan/25 mg hydrochlorothiazide darba kuljum.
English: Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy (see section 4.8).
Maltese: Fatturi ta' riskju għall-iżvilupp ta' glawkoma akuta tal-għeluq tal-angolu jistgħu jinkludu storja ta' allerġija għal sulfonamide jew għall-peniċillina (ara sezzjoni 4.8).
English: Pack size of 28 film-coated tablets in non-perforated calendar blisters.
Maltese: Daqs ta' pakkett ta' 28 pillola miksija b'rita f'folji ta' xahar mhux ipperforati.
English: • After the transition period, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented, which reflects the lowest quantifiable level based on capability of the available analytical methods.
Maltese: • Wara l-perjodu ta' transizzjoni, għandu jiġi implimentat limitu għall-NDMA u l-NDEA ta' massimu ta' 0.03 ppm, li jirrifletti l-inqas livell kwantifikabbli bbażat fuq il-kapaċità talmetodi analitiċi disponibbli.
English: Antigout medicinal products
Maltese: GĦAMLA FARMAĊEWTIKA
English: There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Maltese: Ma kienx hemm evidenza ta' anormalità sistemika jew tossiċità li tattakka l-organu immirat b'dożi klinikament rilevanti.
English: See also information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Irbesartan/Hydrochlorothiazide Teva”.
English: Cases of hypersensitivity reactions such as angioedema, rash, urticaria
Maltese: Każijiet ta' reazzjonijiet ta' sensittività eċċessiva bħal anġjoedema, raxx, urtikarja
English: Efficacy and safety of irbesartan/hydrochlorothiazide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomised, double-blind, active-controlled, 8-week, parallel-arm study.
Maltese: L-effikaċja u s-sigurtà ta' irbesartan/hydrochlorothiazide bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b'aktar minn ċentru wieħed,
English: When Irbesartan/Hydrochlorothiazide Teva 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 Teva tingħata lil pazjenti li għandhom indeboliment fil-funzjoni renali, monitoraġġ perijodiku tal-potassju, kreatinina u aċidu uriku hu rakkomandat.
English: Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended.
Maltese: It-titrazzjoni tad-doża bis-sustanzi individwali (i.e. irbesartan u hydochlorothiazide) jista jiġi rakkomandat.
English: The potential toxicity of the irbesartan/hydrochlorothiazide combination after oral administration was evaluated in rats and macaques in studies lasting up to 6 months.
Maltese: It-tossiċità potenzjali tal-kombinazzjoni ta' irbesartan/ hydrochlorothiazide wara li tingħata mill-ħalq ġiet evalwata f'firien u f'makakki (macaques) waqt studji li damu sa 6 xhur.
English: Additional information on hydrochlorothiazide interactions When administered concurrently, the following medicinal products may interact with thiazide diuretics:
Maltese: Tagħrif addizzjonali dwar l-effetti ta' hydrochlorothiazide ma' mediċini oħra Meta jingħataw flimkien, il-prodotti mediċinali segwenti jistgħu jirreaġixxu ma' dijuretiċi thiazide:
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg fiha 150 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg fiha 300 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Maltese: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 300 mg ta' irbesartan u 25 mg ta' hydrochlorothiazide.
English: The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8).
Maltese: L-użu ta' HCTZ għandu mnejn ikun irid jerġa' jiġi kkunsidrat f'pazjenti li esperjenzaw NMSC qabel (ara wkoll sezzjoni 4.8).
English: Adverse reactions reported with the use of irbesartan alone General disorders and administration site conditions:
Maltese: Reazzjonijiet avversi rapportati bl-użu ta' irbesartan waħdu Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
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, ċenċil fil-widnejn, sogħla, disturbi fit-togħma, indiġestjoni, uġigħ fil-ġogi u l-muskoli, it-testijiet tal funzjoni tal-fwied mhux normali u indeboliment tal-funzjoni tal-kliewi, żieda fil-livell ta' potassju fid demm tiegħek u reazzjonijiet allerġiċi bħal raxx, ħorrieqija, nefħa fil-wiċċ, ix-xofftejn, il-ħalq, l-ilsien jew il-griżmejn.
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Maltese: Mewt kardjovaskulari u puplesija t-tnejn kienu numerikament iktar frekwenti filgrupp ta' aliskiren milli fil-grupp tal-plaċebo, u avvenimenti avversi u avvenimenti avversi serji ta' interess (iperkalimja, pressjoni baxxa u disfunzjoni tal-kliewi) ġew irrappurtati b'mod iktar frekwenti fil-grupp ta' aliskiren milli fil-grupp tal-plaċebo.
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Maltese: Il-pazjenti għandhom jiġu idratati sewwa, u għandha tingħata konsiderazzjoni għall-monitoraġġ tal-funzjoni renali wara l-bidu ta' terapija konkomitanti, u perjodikament wara.
English: Adverse reactions reported with the use of hydrochorothiazide alone Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Maltese: Tabella 3. Reazzjonijiet avversi rrapportati bl-użu ta' hydrochorothiazide waħdu Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi):
English: Acute Myopia and Secondary Acute Angle-Closure Glaucoma Sulfonamide drugs or sulfonamide derivative drugs can cause an idiosyncratic reaction, resulting in transient myopia and acute angle-closure glaucoma.
Maltese: Mijopija Akuta u Glawkoma Akuta Sekondarja ta' Għeluq tal-Angolu mediċini li fihom sulfonamide jew derivat ta' sulfonamide, jistgħu jikkawżaw reazzjoni idjosinkratika, u dan jista' jirriżulta f'mijopija temporanja u glawkoma akuta ta' għeluq talangolu.
English: Other medicines and Irbesartan/Hydrochlorothiazide Teva
Maltese: Mediċini oħra u Irbesartan/Hydrochlorothiazide Teva
English: Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Maltese: Irbesartan jappartjeni għall-grupp ta' mediċini magħrufin bħala antagonisti tarriċetturi angiotensin-II.
English: PC: SN: NN:
Maltese: Puh/Tel:
English: Contents of the pack and other information What Irbesartan/Hydrochlorothiazide Teva contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Irbesartan/Hydrochlorothiazide Teva
English: How to store Irbesartan/Hydrochlorothiazide Teva Contents of the pack and other information
Maltese: Kif taħżen Irbesartan/Hydrochlorothiazide Teva Kontenut tal-pakkett u informazzjoni oħra
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets EU/1/09/583/025-048
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/583/025-048
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Light pink to pink, film-coated capsule shaped tablet.
Maltese: Il-pilloli miksija b'rita ta' Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg huma roża ċari għal roża, miksija b'rita, pilloli f'għamla ta' kapsula.
English: Uncommon: Not known:
Maltese: Mhux magħruf:
English: Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg in patients with mild-to-moderate hypertension.
Maltese: Doża darba kuljum ta' 150 mg irbesartan u 12.5 mg ta' hydrochlorothiazide tat-tnaqqis tal-pressjoni sistolika/dijastolika fil-punt medjan ta' 12.9/6.9 mmHg aġġustat għal plaċebo (24 siegħa wara li ngħatat id-doża) f'pazjenti bi pressjoni għolja bejn ħafifa għal moderata.
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Light pink to pink, film-coated capsule shaped tablet.
Maltese: Il-pilloli miksija b'rita ta' Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg huma roża ċari għal roża, miksija b'rita, pilloli f'għamla ta' kapsula.
English: Package leaflet: information for the patient Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets irbesartan / hydrochlorothiazide
Maltese: Informazzjoni għall-pazjent Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg pilloli miksija b'rita irbesartan / hydrochlorothiazide
English: Treatment of essential hypertension.
Maltese: • Supplimenti tal-vitamina D għal trattament.
English: Each Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg fiha 300 mg irbesartan u 25 mg hydrochlorothiazide.
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 trimester of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance < 30 ml/min) Refractory hypokalaemia, hypercalcaemia
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1, jew għal xi sustanzi oħra derivati minn sulfonamide (hydrochlorothiazide huwa sustanza derivata minn sulfonamide).
English: The determination of an acceptable intake (AI) is based on extrapolation of carcinogenic risk from rodent carcinogenicity data, as the dose resulting in one cancer case among 100,000 individuals exposed for a life-time to the impurity.
Maltese: Id-determinazzjoni ta' konsum aċċettabbli (AI, acceptable intake) hija bbażata fuq estrapolazzjoni ta' riskju karċinoġeniku minn data ta' karċinoġeniċità ta' rodituri, bħala d-doża li tirriżulta f'każ ta' kanċer wieħed fost 100,000 individwu esposti tul il-ħajja kollha għall-impurità.
English: Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Maltese: L-espożizzjoni għal terapija AIIRAs matul it-tieni u t-tielet trimestri hija magħrufa li twassal għal tossiċità tal-fetu uman (tnaqqis fil-funzjoni tal-kliewi, oligohydraminjos, tnaqqis fl-ossifikazzjoni tal-kranju) u tossiċità neonatali (nuqqas fil-funzjoni tal-kliewi, pressjoni baxxa, iperkalemija)
English: Peak plasma concentration occurs at 1.5-2 hours after oral administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.
Maltese: Il-konċentrazzjoni fil-plażma tilħaq l-ogħla livell 1.5-2 sigħat wara li tingħata mill-ħalq għal irbesartan u 1-2.5 sigħat għal hydrochlorothiazide.
English: No teratogenic effects were seen in rats given irbesartan and hydrochlorothiazide in combination at doses that produced maternal toxicity.
Maltese: Ma deherx li kien hemm effetti teratoġeniċi f'firien li ngħataw irbesartan/hydrochlorothiazide flimkien b'dożi li kienu jipproduċu tossiċità materna.
English: Irbesartan/Hydrochlorothiazide Teva is for oral use.
Maltese: Irbesartan/Hydrochlorothiazide Teva.
English: Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol;
Maltese: L-użu flimkien ta' dijuretiċi ta' thiazide jistgħu jżidu linċidenza ta' reazzjonijiet ta' sensittività eċċessiva għal-allopurinol;
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):
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):
English: Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.
Maltese: Minħabba li hemm hydrochlorothiazide f'Irbesartan/Hydrochlorothiazide Teva, jekk tieħu alkoħol waqt li tkun qed fuq trattament b'din il-mediċina, jista' jkollok aktar sturdamenti meta tqum bilwieqfa, speċjalment meta tqum minn pożizzjoni bilqegħda.
English: Aplastic anaemia, bone marrow depression, neutopenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Maltese: Anemija aplastika, depressjoni tal-mudullun,
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Sakemm terapija b'AIIRAs ma tkunx meqjusa essenzjali, il-pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti ta' kontra pressjoni għolja alternattivi li għandhom profil ta' sigurtà stabbilit sabiex jintużaw waqt it-tqala.
English: The other side of the tablet debossed with the number "7238".
Maltese: In-naħa l-oħra tal-pillola hija intaljata bil-kodiċi "7238".
English: Package leaflet: information for the patient Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan / hydrochlorothiazide
Maltese: Informazzjoni għall-pazjent Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg pilloli miksija b'rita irbesartan / hydrochlorothiazide
English: Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
Maltese: Thiazides jaffettwaw il-mekkaniżmu tubulari renali tar-riassorbiment tal-elettroliti u jżidu direttament l-eliminazzjoni tas-sodium u tal-chloride f'ammonti kważi ekwivalenti.
English: The combination of irbesartan and hydrochlorothiazide has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Maltese: Il-kombinazzjoni ta' irbesartan u hydrochlorothiazide rarement ġiet assoċjata ma' pressjoni baxxa sintomatika f'pazjenti bi pressjoni għolja mingħajr fatturi ta' riskju oħra għal pressjoni baxxa.
English: 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 Teva).
Maltese: • jekk ikollok sinjali ta' għatx mhux normali, ħalq xott, dgħufija ġenerali, ħedla, uġigħ fil muskoli jew bugħawwieġ, tqalligħ, remettar, jew il-qalb tħabbat tgħaġġel aktar malajr b'mod abnormali li jistgħu jindikaw effett eċċessiv ta' hydrochlorothiazide (li jinsab f'Irbesartan/Hydrochlorothiazide Teva).
English: Cardiac arrhythmias
Maltese: nekrolisi epidermali tossika,
English: Reproductive system and breast disorders:
Maltese: Disturbi fis-sistema riproduttiva u fis-sider:
English: What Irbesartan/Hydrochlorothiazide Teva is and what it is used for What you need to know before you take Irbesartan/Hydrochlorothiazide Teva How to take Irbesartan/Hydrochlorothiazide Teva Possible side effects
Maltese: Kif għandek tieħu Irbesartan/Hydrochlorothiazide Teva Effetti sekondarji possibbli
English: However, there was no difference in the half-life and accumulation of irbesartan.
Maltese: Madankollu ma kienx hemm differenza filhalf-life u fl-akkumulazzjoni ta' irbesartan.
English: Electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Maltese: glikosurja, ipergliċemija, żieda fiil-kolesterol u trigliċeridi