natgillin/translations-raw huggingface dataset:
Important information about some of the ingredients of Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS contains lactose monohydrate (see “ Further information”).
114 Pomembne informacije o nekaterih sestavinah zdravila Irbesartan Hydrochlorothiazide BMS Zdravilo Irbesartan Hydrochlorothiazide BMS vsebuje laktozo monohidrat (glejte “ Dodatne informacije ”).
Occasional side effects reported since the marketing of Irbesartan Hydrochlorothiazide BMS are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired renal function.
115 Občasni neželeni učinki o katerih so poročali po pridobitvi dovoljenja za promet z zdravilom Irbesartan Hydrochlorothiazide BMS so: glavobol, zvonjenje v ušesih, kašelj, motnje okušanja, prebavne motnje, bolečine v sklepih in mišicah, nenormalno delovanje jeter in okvarjeno delovanje ledvic.
115 As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
V vsakem kombiniranem zdravilu lahko neželene učinke povzroči vsaka od učinkovin, ki jih zdravilo vsebuje.
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Irbesartan Hydrochlorothiazide BMS 300 mg/ 12, 5 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 12, 5 mg hidroklorotiazida.
What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack
116 Izgled zdravila Irbesartan Hydrochlorothiazide BMS in vsebina pakiranja
Irbesartan Hydrochlorothiazide BMS film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Irbesartan Hydrochlorothiazide BMS filmsko obložene tablete so breskove barve, bikonveksne in ovalne oblike, na eni strani imajo vtisnjeno obliko srca, na drugi pa vrezano številko 2876.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12, 5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
116 Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
Imetnik dovoljenja za promet z zdravilom BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Velika Britanija
117 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
117 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
119 NAVODILO ZA UPORABO Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg filmsko obložene tablete irbesartan/ hidroklorotiazid
120 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) You must tell your doctor if you think that you are (or might become) pregnant.
120 če imate težave z ledvicami, vključno s presaditvijo ledvice če imate težave s srcem če imate težave z jetri če imate sladkorno bolezen če imate eritematozni lupus (znan tudi kot lupus ali sistemski eritematozni lupus) Zdravniku morate povedati, če mislite, da ste noseči, ali če načrtujete nosečnost.
Important information about some of the ingredients of Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS contains lactose monohydrate (see “ Further information”).
121 Pomembne informacije o nekaterih sestavinah zdravila Irbesartan Hydrochlorothiazide BMS Zdravilo Irbesartan Hydrochlorothiazide BMS vsebuje laktozo monohidrat (glejte “ Dodatne informacije ”).
Occasional side effects reported since the marketing of Irbesartan Hydrochlorothiazide BMS are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired renal function.
122 Občasni neželeni učinki o katerih so poročali po pridobitvi dovoljenja za promet z zdravilom Irbesartan Hydrochlorothiazide BMS so: glavobol, zvonjenje v ušesih, kašelj, motnje okušanja, prebavne motnje, bolečine v sklepih in mišicah, nenormalno delovanje jeter in okvarjeno delovanje ledvic.
122 As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
V vsakem kombiniranem zdravilu lahko neželene učinke povzroči vsaka od učinkovin, ki jih zdravilo vsebuje.
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Ena Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack
123 Izgled zdravila Irbesartan Hydrochlorothiazide BMS in vsebina pakiranja
Irbesartan Hydrochlorothiazide BMS film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Irbesartan Hydrochlorothiazide BMS filmsko obložene tablete so rožnate barve, bikonveksne in ovalne oblike, na eni strani imajo vtisnjeno obliko srca, na drugi pa vrezano številko 2788.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
123 Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
Imetnik dovoljenja za promet z zdravilom BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Velika Britanija
124 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
124 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
What is Irbesartan Hydrochlorothiazide Winthrop?
Kaj je zdravilo Irbesartan Hydrochlorothiazide Winthrop?
Irbesartan Hydrochlorothiazide Winthrop is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Winthrop je zdravilo, ki vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
This medicine is the same as Coaprovel, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Coaprovel, ki je že odobreno v Evropski uniji (EU).
The company that makes Coaprovel has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide Winthrop.
Družba, ki proizvaja zdravilo Coaprovel, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Irbesartan Hydrochlorothiazide Winthrop.
What is Irbesartan Hydrochlorothiazide Winthrop used for?
Za kaj se zdravilo Irbesartan Hydrochlorothiazide Winthrop uporablja?
Irbesartan Hydrochlorothiazide Winthrop is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
„ Esencialna “ pomeni, da visok krvni tlak ni posledica nobenega drugega bolezenskega stanja.
Irbesartan Hydrochlorothiazide Winthrop has not been tested in patients below 18 years of age.
Uporaba zdravila Irbesartan Hydrochlorothiazide Winthrop pri bolnikih, mlajših od 18 let, še ni bila preizkušena.
How is Irbesartan Hydrochlorothiazide Winthrop used?
Kako se zdravilo Irbesartan Hydrochlorothiazide Winthrop uporablja?
Irbesartan Hydrochlorothiazide Winthrop is taken by mouth, with or without food.
Zdravilo Irbesartan Hydrochlorothiazide Winthrop se zaužije peroralno, s hrano ali brez nje.
The dose of Irbesartan Hydrochlorothiazide Winthrop to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Odmerek zdravila Irbesartan Hydrochlorothiazide Winthrop, ki naj ga bolnik uporabi, je odvisen od odmerka irbesartana ali hidroklorotiazida, ki ga je bolnik jemal prej.
Irbesartan Hydrochlorothiazide Winthrop may be added to other treatments for hypertension.
Zdravilo Irbesartan Hydrochlorothiazide Winthrop se lahko uvede sočasno z drugimi načini zdravljenja hipertenzije.
How does Irbesartan Hydrochlorothiazide Winthrop work?
Kako zdravilo Irbesartan Hydrochlorothiazide Winthrop deluje?
Irbesartan Hydrochlorothiazide Winthrop contains two active substances, irbesartan and hydrochlorothiazide.
Zdravilo Irbesartan Hydrochlorothiazide Winthrop vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
How has Irbesartan Hydrochlorothiazide Winthrop been studied?
Kako je bilo zdravilo Irbesartan Hydrochlorothiazide Winthrop raziskano?
The studies of Karvea/ Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Winthrop.
V podporo uporabi zdravila Irbesartan Hydrochlorothiazide Winthrop so bile uporabljene študije z zdraviloma Karvea/ Aprovel, uporabljenima skupaj z hidroklorotiazidom v ločenih tabletah.
What benefit has Irbesartan Hydrochlorothiazide Winthrop shown during the studies?
Kakšne koristi je zdravilo Irbesartan Hydrochlorothiazide Winthrop izkazalo med raziskavami?
Irbesartan Hydrochlorothiazide Winthrop was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Zdravilo Irbesartan Hydrochlorothiazide Winthrop je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in od hidroklorotiazida kot samostojnega zdravila.
What is the risk associated with Irbesartan Hydrochlorothiazide Winthrop?
Kakšna tveganja so povezana z zdravilom Irbesartan Hydrochlorothiazide Winthrop?
The most common side effects with Irbesartan Hydrochlorothiazide Winthrop (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen( BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles).
Najpogostejši neželeni učinki zdravila Irbesartan Hydrochlorothiazide Winthrop (opaženi pri 1 do 10 bolnikih izmed 100) so omotica, navzeja (občutek slabosti) ali bruhanje, nenormalno uriniranje, utrujenost in povečane vrednosti dušika sečnine v krvi (BUN, produkta razgradnje beljakovin), kreatinina (produkta metabolizma mišic) in kreatin kinaze (encima, ki ga najdemo v mišicah).
For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Winthrop, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Irbesartan Hydrochlorothiazide Winthrop, glejte navodilo za uporabo.
Irbesartan Hydrochlorothiazide Winthrop should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Zdravila Irbesartan Hydrochlorothiazide Winthrop ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) irbesartan, hidroklorotiazid, sulfonamide ali katero koli drugo sestavino zdravila.
Irbesartan Hydrochlorothiazide Winthrop should also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Zdravila Irbesartan Hydrochlorothiazide Winthrop prav tako ne smejo uporabljati bolniki s hudim obolenjem jeter, ledvic ali žolčnika ali bolniki s prenizko koncentracijo kalija v krvi ali s previsoko koncentracijo kalcija v krvi.
Care must be taken when using Irbesartan Hydrochlorothiazide Winthrop with other medicines that have an effect on blood potassium levels.
Posebna pozornost je potrebna, če se zdravilo Irbesartan Hydrochlorothiazide Winthrop jemlje sočasno z drugimi zdravili, ki vplivajo na koncentracijo kalija v krvi.
Why has Irbesartan Hydrochlorothiazide Winthrop been approved?
Zakaj je bilo zdravilo Irbesartan Hydrochlorothiazide Winthrop odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide Winthrop’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Irbesartan Hydrochlorothiazide Winthrop pri zdravljenju esencialne hipertenzije pri bolnikih, pri katerih samo z irbesartanom ali samo s hidroklorotiazidom ni mogoče ustrezno nadzorovati krvnega tlaka, večje od z njim povezanih tveganj.
The Committee recommended that Irbesartan Hydrochlorothiazide Winthrop be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Irbesartan Hydrochlorothiazide Winthrop odobri dovoljenje za promet.
Other information about Irbesartan Hydrochlorothiazide Winthrop:
Druge informacije o zdravilu Irbesartan Hydrochlorothiazide Winthrop:
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Hydrochlorothiazide Winthrop to Sanofi Pharma Bristol-Myers Squibb SNC on 19 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Hydrochlorothiazide Winthrop, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pharma Bristol- Myers Squibb SNC dne 19. januarja 2007.
The full EPAR for Irbesartan Hydrochlorothiazide Winthrop is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Irbesartan Hydrochlorothiazide Winthrop je na voljo tukaj.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg tablets.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12, 5 mg tablete
Irbesartan Hydrochlorothiazide Winthrop can be taken once daily, with or without food.
Bolniki lahko zdravilo Irbesartan Hydrochlorothiazide Winthrop jemljejo enkrat na dan skupaj s hrano ali brez nje.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg.
Zdravilo Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12, 5 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem s 300 mg irbesartana ali z zdravilom Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12, 5 mg ni dovolj znižal.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg.
Zdravilo Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem z zdravilom Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12, 5 mg ni dovolj znižal.
When necessary, Irbesartan Hydrochlorothiazide Winthrop may be administered with another antihypertensive medicinal product (see section 4.5).
Kadar je nujno, smejo bolniki poleg zdravila Irbesartan Hydrochlorothiazide Winthrop jemati tudi drug antihipertenziv (glejte poglavje 4. 5).
Renal impairment: due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide Winthrop is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/ min).
Ledvična okvara: zdravilo Irbesartan Hydrochlorothiazide Winthrop vsebuje hidroklorotiazid, zato za bolnike s hudo motenim ledvičnim delovanjem (očistek kreatinina < 30 ml/ min) ni primeren.
2 Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide Winthrop.
2 Zmanjšan intravaskularni volumen: zmanjšan intravaskularni volumen ali pomanjkanje natrija je treba popraviti pred začetkom uporabe zdravila Irbesartan Hydrochlorothiazide Winthrop.
Irbesartan Hydrochlorothiazide Winthrop is not indicated in patients with severe hepatic impairment.
Jetrna okvara: zdravilo Irbesartan Hydrochlorothiazide Winthrop ni primerno za bolnike s hudo jetrno okvaro.
No dosage adjustment of Irbesartan Hydrochlorothiazide Winthrop is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Pri bolnikih z blago do zmerno jetrno okvaro prilagoditev odmerka ni potrebna (glejte poglavje 4. 3).
Elderly patients: no dosage adjustment of Irbesartan Hydrochlorothiazide Winthrop is necessary in elderly patients.
Starejši bolniki: starejšim bolnikom odmerka zdravila Irbesartan Hydrochlorothiazide Winthrop ni treba prilagajati.
Irbesartan Hydrochlorothiazide Winthrop has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Hipotenzija - zmanjšan intravaskularni volumen: simptomatska hipotenzija se pri bolnikih z zvišanim krvnim tlakom, ki jemljejo zdravilo Irbesartan Hydrochlorothiazide Winthrop, nimajo pa drugih dejavnikov tveganja za hipotenzijo, pojavi le redko.
Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide Winthrop.
Ta stanja je treba popraviti pred začetkom zdravljenja z zdravilom Irbesartan Hydrochlorothiazide Winthrop.
While this is not documented with Irbesartan Hydrochlorothiazide Winthrop, a similar effect should be anticipated.
Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom Irbesartan Hydrochlorothiazide Winthrop, čeprav to pri zdravljenju z njim ni bilo dokazano.
Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide Winthrop is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Ledvična okvara in presaditev ledvic: če se zdravilo Irbesartan Hydrochlorothiazide Winthrop uporablja pri bolnikih z okvarjeno ledvično funkcijo, je priporočena redna kontrola serumske koncentracije kalija, kreatinina in sečne kisline.
There is no experience regarding the administration of Irbesartan Hydrochlorothiazide Winthrop in patients with a recent kidney transplantation.
Izkušenj z uporabo zdravila Irbesartan Hydrochlorothiazide Winthrop pri bolnikih po nedavni presaditvi ledvice ni.
Irbesartan Hydrochlorothiazide Winthrop should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Zdravilo Irbesartan Hydrochlorothiazide Winthrop se pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/ min) ne sme uporabljati (glejte poglavje 4. 3).
There is no clinical experience with Irbesartan Hydrochlorothiazide Winthrop in patients with hepatic impairment.
Kliničnih izkušenj z uporabo zdravila Irbesartan Hydrochlorothiazide Winthrop pri bolnikih z jetrno okvaro ni.
Therefore, the use of Irbesartan Hydrochlorothiazide Winthrop is not recommended.
Uporaba zdravila Irbesartan Hydrochlorothiazide Winthrop pri njih zato ni priporočena.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide Winthrop, minimal or no effects were reported.
Pri bolnikih, ki so jemali po 12, 5 mg hidroklorotiazida, kolikor ga vsebuje zdravilo Irbesartan Hydrochlorothiazide Winthrop, je bil ta učinek zelo majhen ali pa ga sploh ni bilo.
Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide Winthrop hyperkalaemia might occur, especially in the presence of renal impairment and/ or heart failure, and diabetes mellitus.
Nasprotno pa se lahko zaradi irbesartana, ki ga vsebuje zdravilo Irbesartan Hydrochlorothiazide Winthrop, pojavi hiperkaliemija, zlasti pri bolnikih z ledvično okvaro in/ ali srčnim popuščanjem ter sladkorno boleznijo.
Potassium-sparing diuretics, potassium supplements or potassium- containing salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide Winthrop (see section 4.5).
Pri hkratnem zdravljenju z diuretiki, ki varčujejo kalij, pripravki s kalijem, nadomestki soli, ki vsebujejo kalij, in zdravilom Irbesartan Hydrochlorothiazide Winthrop je potrebna posebna previdnost (glejte poglavje 4. 5).
Lithium: the combination of lithium and Irbesartan Hydrochlorothiazide Winthrop is not recommended (see section 4.5).
Litij: kombinacija litija in zdravila Irbesartan Hydrochlorothiazide Winthrop ni priporočena (glejte poglavje 4. 5).
4 Pregnancy:
4 Nosečnost:
Other antihypertensive agents: the antihypertensive effect of Irbesartan Hydrochlorothiazide Winthrop may be increased with the concomitant use of other antihypertensive agents.
Drugi antihipertenzivi: antihipertenzijski učinek zdravila Irbesartan Hydrochlorothiazide Winthrop se lahko med sočasno uporabo drugih antihipertenzivov zveča.
Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide Winthrop.
Tiazidi zmanjšujejo ledvični očistek litija, zato se med zdravljenjem z zdravilom Irbesartan Hydrochlorothiazide Winthrop poveča nevarnost zastrupitve z litijem.
Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide Winthrop is not recommended (see section 4.4).
Sočasna uporaba litija in zdravila Irbesartan Hydrochlorothiazide Winthrop zato ni priporočljiva (glejte poglavje 4. 4).
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Irbesartan Hydrochlorothiazide Winthrop is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
Zdravila, na katera vpliva serumska koncentracija kalija: med hkratnim zdravljenjem z zdravilom Irbesartan Hydrochlorothiazide Winthrop in drugimi zdravili, na katerih delovanje vpliva serumska koncentracija kalija (npr. z digitalisovimi glikozidi, antiaritmiki), je priporočeno redno preverjanje kalija v serumu.
Irbesartan is mainly metabolised by CYP2C9 and to a lesser
Opazili niso nobenih pomembnih farmakokinetičnih in farmakodinamičnih interakcij pri sočasni uporabi irbesartana in varfarina, zdravila, ki se presnavlja
5 extent by glucuronidation.
5 preko CYP2C9.
Unless continued
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim
6 AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
6 varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
Since Irbesartan Hydrochlorothiazide Winthrop contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Zdravilo Irbesartan Hydrochlorothiazide Winthrop vsebuje hidroklorotiazid, zato njegova uporaba v prvem trimesečju nosečnosti ni priporočena.
Irbesartan Hydrochlorothiazide Winthrop is contraindicated during breast-feeding.
Med dojenjem je uporaba zdravila Irbesartan Hydrochlorothiazide Winthrop kontraindicirana.
Based on its pharmacodynamic properties, Irbesartan Hydrochlorothiazide Winthrop is unlikely to affect this ability.
Na osnovi farmakodinamičnih lastnosti je malo verjetno, da bi zdravilo Irbesartan Hydrochlorothiazide Winthrop vplivalo na te sposobnosti.
Uncommon:
zardevanje
7
7 Bolezni prebavil: pogosti: občasni:
Uncommon:
Bolezni mišično- skeletnega sistema in vezivnega tkiva: občasni: