FrancophonIA/ELRC3.0 huggingface dataset:
English: Teva Norway AS Tlf: +47 66775590
Croatian: Tlf: +47 66775590
English: Pregelatinized starch (maize) Poloxamer 188
Croatian: Jezgra tablete: povidon kukuruzni škrob, prethodno geliran poloksamer 188
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Nazivi i adrese proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Nervous system disorders:
Croatian: Poremećaji živčanog sustava:
English: Antidiabetic medicinal products (oral agents and insulins) Dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Croatian: Antidijabetici (oralni pripravci i inzulini) Može biti potrebna prilagodba doze antidijabetika (vidjeti dio 4.4.);
English: Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.
Croatian: Jezgra tablete: povidon, prethodno geliran kukuruzni škrob, poloksamer 188, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat.
English: Investigations:
Croatian: Pretrage:
English: Pharmachemie B.V. Swensweg 5
Croatian: Velika Britanija Pharmachemie B.V.
English: The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan.
Croatian: Učinak hidroklorotiazida na sniženje razine kalija umanjen je učinkom irbesartana koji štedi izlučivanje kalija.
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.
Croatian: U skupini podvrgnutoj kombiniranoj terapiji bilo je 0,6% bolesnika s hipotenzijom i 2,8% bolesnika s omaglicom kao nuspojavama, dok je taj postotak u skupini na monoterapiji iznosio 0% za hipotenziju i 3,1% za omaglicu.
English: The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Croatian: Hidroklorotiazid iz ovoga lijeka može dati pozitivne rezultate anti-doping testa.
English: Suggested measures include induction of emesis and/or gastric lavage.
Croatian: Preporučene mjere uključuju poticanje povraćanja i/ili ispiranje želuca.
English: Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
Croatian: Irbesartan se metabolizira u jetri glukuronidacijom i oksidacijom.
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.
Croatian: BUN; 2,3%), kreatin kinaze (1,7%) i kreatinina (1,1%).
English: The administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients;
Croatian: U nekih bolesnika primjena nesteroidnih protuupalnih lijekova može smanjiti diuretski, natriuretski i antihipertenzivni učinak tiazida;
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Croatian: Podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) kombiniranom primjenom ACE inhibitora, blokatora angiotenzin II receptora ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija, hiperkalemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) u usporedbi s primjenom samo jednog lijeka koji djeluje na RAAS (vidjeti dijelove 4.3, 4.4 i 5.1).
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and
Croatian: Dojenčad čije su majke uzimale antagoniste receptora angiotenzina II treba pažljivo pratiti zbog moguće hipotenzije (također vidjeti dijelove 4.3. i 4.4.).
English: In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Croatian: U bolesnika s oštećenom bubrežnom funkcijom ili u bolesnika na hemodijalizi farmakokinetički parametri irbesartana nisu bitno promijenjeni.
English: No dosage adjustment is necessary in older people.
Croatian: U starijih bolesnika nije potrebno prilagođavati dozu.
English: Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Irbesartan/Hydrochlorothiazide Teva.
Croatian: Dodatne informacije o pojedinačnim komponentama lijeka: uz navedene nuspojave kombiniranog lijeka, moguće nuspojave lijeka Irbesartan/Hidroklorotiazid Teva mogu biti i one prethodno prijavljene za pojedinačne komponente lijeka.
English: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)
Croatian: Nemelanomski rak kože (karcinom bazalnih stanica i karcinom skvamoznih stanica)
English: There is no difference in response to irbesartan/hydrochlorothiazide, regardless of age or gender.
Croatian: Ne postoji razlika u terapijskom odgovoru bolesnika na irbesartan/hidroklorotiazid s obzirom na spol i dob.
English: Thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Croatian: Tiazidima izazvana hipokalijemija ili hipomagnezijemija potiču pojavu srčanih aritmija uzrokovanih digitalisom (vidjeti dio 4.4.);
English: Irbesartan/Hydrochlorothiazide Teva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Croatian: Teva ne preporučuje se majkama koje doje, a Vaš liječnik može izabrati drugu terapiju ako želite dojiti, osobito ako se radi o dojenju novorođenčeta ili nedonoščeta.
English: Since Irbesartan/Hydrochlorothiazide Teva contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Croatian: Teva sadrži hidroklorotiazid, ne preporučuje se tijekom prvog tromjesečja trudnoće.
English: Peak plasma concentration occurs at 1.5-2 hours after oral administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.
Croatian: Vršnu koncentraciju u plazmi nakon peroralne primjene irbesartan postiže za 1,5-2 sata, a hidroklorotiazid za 1-2,5 sata.
English: For Irbesartan/Hydrochlorothiazide Teva packaged in aluminium - aluminium blisters: This medicinal product does not require any special storage conditions.
Croatian: Irbesartan/Hidroklorotiazid Teva u aluminij - aluminij blisterima: Lijek ne zahtjeva posebne uvjete čuvanja.
English: After either oral or intravenous administration of 14C irbesartan, about 20 % of the radioactivity is recovered in the urine, and the remainder in the faeces.
Croatian: 14C irbesartana oko 20% radioaktivnosti pojavilo se u mokraći, a ostatak u stolici.
English: However, occasionally dizziness or weariness may occur during treatment of high blood pressure.
Croatian: Međutim, za vrijeme liječenja povišenog krvnog tlaka povremeno se mogu pojaviti omaglica ili umor.
English: Hyperkalaemia
Croatian: Hiperkalijemija
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Irbesartan/Hidroklorotiazid Teva Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: 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 Teva.
Croatian: ako iskusite povećanu osjetljivost kože na sunce s pojavom simptoma sunčanih opeklina (kao što su crvenilo kože, svrbež, oticanje, nastanak mjehurića), a pojavljuju se brže nego što je normalno ako trebate ići na operaciju (kirurški zahvat) ili trebate primiti anestetike ako tijekom uzimanja lijeka Irbesartan/Hidroklorotiazid Teva primijetite promjene vida ili bol u jednom ili oba oka.
English: ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Croatian: ACE inhibitori i blokatori angiotentin II receptora ne smiju se primjenjivati istodobno u bolesnika s dijabetičkom nefropatijom.
English: Irbesartan/Hydrochlorothiazide Teva should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3).
Croatian: Irbesartan/Hidroklorotiazid Teva ne smiju uzimati bolesnici s teško oštećenom funkcijom bubrega (klirens kreatinina <30 ml/min) (vidjeti dio 4.3).
English: Irbesartan/Hydrochlorothiazide Teva will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction.
Croatian: Liječnik će Vam obično propisati Irbesartan/Hidroklorotiazid Teva ako Vam dosadašnje liječenje povišenog krvnog tlaka nije osiguralo odgovarajući učinak.
English: (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Croatian: Velika primjena hidroklorotiazida (≥50 000 mg kumulativno) bila je povezana s prilagođenim OR od 1,29 (95% CI: 1,23-1,35) za BCC i 3,98 (95% CI: 3,68-4,31) za SCC.
English: No dosage adjustment of Irbesartan/Hydrochlorothiazide Teva is necessary in older people.
Croatian: Nije potrebno prilagođavati dozu lijeka Irbesartan/Hidroklorotiazid Teva za starije osobe.
English: Pack size of 50x1 film coated tablet in unit dose blisters.
Croatian: Pakiranje od 50 x 1 filmom obloženom tabletom u perforiranim blisterima djeljivi na jedinične doze.
English: Non-steroidal anti-inflammatory drugs
Croatian: Nesteroidni protuupalni lijekovi
English: Electrolytes should be monitored during concomitant use.
Croatian: Tijekom istovremene primjene treba pratiti razine elektrolita.
English: Non-melanoma skin cancer
Croatian: Nemelanomski rak kože
English: Irbesartan/Hydrochlorothiazide Teva with alcohol
Croatian: Irbesartan/Hidroklorotiazid Teva s alkoholom
English: Side effects associated with irbesartan alone:
Croatian: Nuspojave prijavljene kod uzimanja samo irbesartana:
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Croatian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
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).
Croatian: Poznato je da u ljudi terapija antagonistima receptora angiotenzina II tijekom drugog i trećeg tromjesečja izaziva fetotoksičnost (smanjena bubrežna funkcija, oligohidramnion, poremećaj okoštavanja lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenzija, hiperkalijemija) (vidjeti dio 5.3.).
English: • During this period, NDMA and NDEA impurities in the API should be controlled for a transition period at limits calculated based on the principles of ICH M7(R1) using validated assays
Croatian: • Tijekom tog razdoblja potrebno je primjenom validiranih testova kontrolirati jesu li NDMA i NDEA nečistoće u aktivnim farmaceutskim sastojcima u prijelaznom razdoblju u granicama izračunatima na temelju načela iz Smjernica ICH M7(R1).
English: Pharmacotherapeutic group: angiotensin-II antagonists, combinations ATC code: C09D A04
Croatian: ATK oznaka: C09D A04
English: Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as 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.
Croatian: Gubitak apetita; nadraženost želuca; grčevi u želucu; zatvor; žutica (žućkasta boja kože i/ili bjeloočnica); upala gušterače koju karakterizira jaka bol u gornjem dijelu trbuha, često s mučninom i povraćanjem; poremećaji spavanja; depresija; zamagljen vid; smanjenje broja bijelih krvnih stanica, što može rezultirati čestim infekcijama i vrućicom; smanjenje broja trombocita (krvne stanice neophodne za zgrušavanje krvi); smanjenje broja crvenih krvnih stanica (anemija), praćeno umorom, glavoboljom, nedostatkom zraka prilikom vježbanja, omaglicom i blijedim izgledom; bolest bubrega; problemi s plućima, uključujući upalu pluća i nakupljanje tekućine u plućima; povećana osjetljivost kože na sunce; upala krvnih žila; kožna bolest koju karakterizira ljuštenje kože po cijelom tijelu; kožni eritemski lupus, koji se očituje kao osip koji se javlja na licu, vratu i vlasištu; alergijske reakcije; slabost i spazam mišića; promjene brzine otkucaja srca; pad krvnog tlaka nakon promjene položaja tijela; oticanje žlijezda slinovnica; visoka vrijednost šećera u krvi; šećer u mokraći, povećanje nekih vrsta masnoća u krvi; visoke koncentracije mokraćne kiseline u krvi, što može dovesti do gihta.
English: In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolic/diastolic mean reduction of 11.1/7.2 mmHg.
Croatian: Bolesnicima čiji se tlak ne može učinkovito kontrolirati samo sa 25 mg hidroklorotiazida, dodatak irbesartana omogućuje dodatno smanjenje sistoličkog/dijastoličkog tlaka (korigirano za placebo) za prosječno 11,1/7,2 mmHg.
English: Electrolyte imbalance
Croatian: Poremećaj elektrolita
English: Irbesartan/Hydrochlorothiazide Teva is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Croatian: Teva je kombinacija irbesartana, antagonista receptora angiotenzina II i hidroklorotiazida, tiazidskog diuretika.
English: Immune system disorders:
Croatian: Poremećaji imunološkog sustava:
English: Eye disorders:
Croatian: Poremećaji oka:
English: Lithium The combination of lithium and Irbesartan/Hydrochlorothiazide Teva is not recommended (see section 4.5).
Croatian: Litij Ne preporučuje se kombinacija litija i lijeka Irbesartan/Hidroklorotiazid Teva (vidjeti dio 4.5).
English: In patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Croatian: U bolesnika s blagom do umjerenom cirozom farmakokinetički parametri irbesartana nisu bitno promijenjeni.
English: White opaque PVC-PVdC - Aluminium blisters: Do not store above 30°C.
Croatian: Bijeli neprozirni PVC-PVdC - aluminijski blisteri: Ne čuvati na temperaturi iznad 30°C.
English: Fever
Croatian: Vrućica
English: Pressor amines (e.g. noradrenaline) The effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Croatian: Učinak presornih amina može biti smanjen, ali ne dovoljno da se isključi njihova primjena;
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of Irbesartan/Hydrochlorothiazide Teva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Croatian: • Istodobna primjena lijeka Irbesartan/Hidroklorotiazid Teva s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1)
English: The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mmHg.
Croatian: Dodatak 12,5 mg hidroklorotiazida dozi od 300 mg irbesartana jedanput na dan bolesnicima koji nisu odgovarajuće kontrolirani sa 300 mg irbesartana u monoterapiji doveo je do daljnjeg smanjenja dijastoličkog krvnog tlaka (u usporedbi s placebom) za 6,1 mm Hg u vrijeme najniže koncentracije u krvi (24 sata nakon uzimanja doze).
English: The active ingredients are irbesartan and hydrochlorothiazide.
Croatian: Djelatne tvari su irbesartan i hidroklorotiazid.
English: Hydrochlorothiazide
Croatian: Hidroklorotiazid
English: Magyarország
Croatian: Mađarska
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of irbesartan/hydrochlorothiazide 150 mg/12.5 mg were 100 %.
Croatian: Na osnovi ambulantnih mjerenja krvnog tlaka, učinci najniže i najviše koncentracije pri primjeni irbesartana/hidroklorotiazida 150 mg/12,5 mg iznosili su 100%.
English: No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥ 30 ml/min.
Croatian: Nije potrebno prilagođavati dozu u bolesnika koji imaju oslabljenu funkciju bubrega, s klirensom kreatinina ≥ 30 ml/min.
English: There is no experience regarding the administration of Irbesartan/Hydrochlorothiazide Teva in patients with a recent kidney transplantation.
Croatian: Nema iskustava s primjenom lijeka Irbesartan/Hidroklorotiazid Teva u bolesnika kojima je nedavno transplantiran bubreg.
English: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Croatian: Nemelanomski rak kože: Na temelju dostupnih podataka iz epidemioloških ispitivanja, između HCTZa i NMSC-a primijećena je povezanost ovisna o kumulativnoj dozi.
English: Teva Italia S.r.l.
Croatian: TEVA UK Ltd
English: Swelling extremity Arthralgia, myalgia
Croatian: Artralgija, mijalgija
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KALENDARSKO PAKIRANJE (BLISTER)
English: For Irbesartan/Hydrochlorothiazide Teva packaged in white opaque PVC-PVdC - aluminium blisters: Do not store above 30°C.
Croatian: Irbesartan/Hidroklorotiazid Teva u bijelim, neprozirnim PVC-PVdC - aluminij blisterima: Ne čuvati na temperaturi iznad 30°C.
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).
Croatian: Pri najnižoj koncentraciji lijeka u krvi, 47,2% bolesnika koji su primali kombinaciju irbesartan/hidroklorotiazid postiglo je dijastolički tlak < 90 mmHg, u usporedbi sa 33,2% bolesnika koji su primali irbesartan (p<0,0005).
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Irbesartan/Hydrochlorothiazide Teva (see section 4.5).
Croatian: Diuretici koje štede kalij, nadomjesci kalija ili nadomjesci soli koji sadrže kalij moraju se s oprezom istodobno primjenjivati s lijekom Irbesartan/Hidroklorotiazid Teva (vidjeti dio 4.5.).
English: One side of the tablet debossed with the number "93".
Croatian: Na jednoj strani tablete je utisnut broj “93”.
English: België/Belgique/Belgien
Croatian: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG
English: No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega čiji je klirens kreatinina ≥ 30 ml/min (vidjeti dijelove 4.3. i
English: When assessed by ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12.5 mg hydrochlorothiazide once daily produced consistent reduction in blood pressure over the 24 hours period with mean 24-hour placebosubtracted systolic/diastolic reductions of 15.8/10.0 mmHg.
Croatian: Na osnovi ambulantnih mjerenja krvnog tlaka, utvrđeno je da kombinacija od 150 mg irbesartana i 12,5 mg hidroklorotiazida jednom na dan uzrokuje konzistentno smanjenje krvnog tlaka u periodu od 24 sata, s prosječnim24-satnim smanjenjem sistoličkog/dijastoličkog krvnog tlaka (korigiranim za rezultate placebo skupine) od 15,8/10,0 mm Hg.
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Croatian: Ako se antagonisti receptora angiotenzina II uzimaju od drugog tromjesečja trudnoće na dalje, preporučuje se ultrazvučni pregled funkcije bubrega i lubanje.
English: Adverse reactions reported with the use of hydrochorothiazide alone Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Croatian: Tablica 3. Nuspojave (bez obzira na povezanost s lijekom) prijavljene pri primjeni samo hidroklorotiazida Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe):
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with irbesartan and hydrochlorothiazide combinations.
Croatian: Nadalje, tiazidi smanjuju renalni klirens litija pa uzimanje kombinacija irbesartana i hidroklorotiazida može povećati rizik od toksičnosti litija.
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).
Croatian: ako imate simptome kao što su neuobičajena žeđ, suha usta, opća slabost, omamljenost, grčevi ili bol u mišićima, mučnina, povraćanje ili neuobičajeno brzi otkucaji srca jer oni mogu upućivati na pretjerani učinak hidroklorotiazida (sastojak lijeka Irbesartan/Hidroklorotiazid Teva).
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.
Croatian: Manje nego proporcionalan porast oralne apsorpcije uočen je pri dozama većima od 600 mg; mehanizam tog porasta nije poznat.
English: Weakness, muscle spasm
Croatian: Slabost, mišićni spazam
English: The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Croatian: Nije utvrđeno u kojoj se mjeri hidroklorotiazid uklanja hemodijalizom.
English: Teva Denmark A/S Tlf: +45 44985511
Croatian: Tlf: +45 44985511
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.
Croatian: Osim ako se nastavak terapije antagonistima receptora angiotenzina II ne smatra neophodnim, bolesnice koje planiraju trudnoću trebaju prijeći na alternativnu antihipertenzivnu terapiju s potvrđenom sigurnošću primjene u trudnoći.
English: Talk to your doctor before taking Irbesartan/Hydrochlorothiazide Teva and if any of the following apply to you:
Croatian: Obratite se svom liječniku prije nego uzmete Irbesartan/Hidroklorotiazid Teva i ako se bilo što od sljedećeg odnosi na Vas: ako značajno povraćate ili imate jaki proljev.