natgillin/translations-raw huggingface dataset:
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
77 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 06/ 375/ 016 14 tablets EU/ 1/ 06/ 375/ 017 28 tablets EU/ 1/ 06/ 375/ 018 56 tablets EU/ 1/ 06/ 375/ 019 56 x 1 tablets EU/ 1/ 06/ 375/ 020 84 tablets EU/ 1/ 06/ 375/ 021 98 tablets
EU/ 1/ 06/ 375/ 016 14 tablet EU/ 1/ 06/ 375/ 017 28 tablet EU/ 1/ 06/ 375/ 018 56 tablet EU/ 1/ 06/ 375/ 019 56 x 1 tablet EU/ 1/ 06/ 375/ 020 84 tablet EU/ 1/ 06/ 375/ 021 98 tablet
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
79 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
80 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 06/ 375/ 022 14 tablets EU/ 1/ 06/ 375/ 023 28 tablets EU/ 1/ 06/ 375/ 024 56 tablets EU/ 1/ 06/ 375/ 025 56 x 1 tablets EU/ 1/ 06/ 375/ 026 84 tablets EU/ 1/ 06/ 375/ 027 98 tablets
EU/ 1/ 06/ 375/ 022 14 tablet EU/ 1/ 06/ 375/ 023 28 tablet EU/ 1/ 06/ 375/ 024 56 tablet EU/ 1/ 06/ 375/ 025 56 x 1 tablet EU/ 1/ 06/ 375/ 026 84 tablet EU/ 1/ 06/ 375/ 027 98 tablet
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
82 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
83 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 06/ 375/ 028 14 tablets EU/ 1/ 06/ 375/ 029 28 tablets EU/ 1/ 06/ 375/ 030 56 tablets EU/ 1/ 06/ 375/ 031 56 x 1 tablets EU/ 1/ 06/ 375/ 032 84 tablets EU/ 1/ 06/ 375/ 033 98 tablets
EU/ 1/ 06/ 375/ 028 14 tablet EU/ 1/ 06/ 375/ 029 28 tablet EU/ 1/ 06/ 375/ 030 56 tablet EU/ 1/ 06/ 375/ 031 56 x 1 tablet EU/ 1/ 06/ 375/ 032 84 tablet EU/ 1/ 06/ 375/ 033 98 tablet
85 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
85 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
INFORMATION FOR THE USER Irbesartan BMS 75 mg tablets irbesartan
87 NAVODILO ZA UPORABO Irbesartan BMS 75 mg tablete irbesartan
What Irbesartan BMS is and what it is used for 2.
Kaj je zdravilo Irbesartan BMS in za kaj ga uporabljamo 2.
Before you take Irbesartan BMS 3.
Kaj morate vedeti, preden boste vzeli zdravilo Irbesartan BMS 3.
How to take Irbesartan BMS 4.
Kako jemati zdravilo Irbesartan BMS 4.
How to store Irbesartan BMS 6.
Shranjevanje zdravila Irbesartan BMS 6.
Irbesartan BMS belongs to a group of medicines known as angiotensin-II receptor antagonists.
Zdravilo Irbesartan BMS spada v skupino zdravil, ki so znana kot antagonisti angiotenzina- II.
Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Zdravilo Irbesartan BMS preprečuje vezavo angiotenzina- II na te receptorje in tako sprošča krvne žile ter znižuje krvni tlak.
Irbesartan BMS is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Zdravilo Irbesartan BMS uporabljamo: za zdravljenje povečanega krvnega tlaka (primarne hipertenzije). za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in laboratorijsko potrjeno okvaro delovanja ledvic.
BEFORE YOU TAKE IRBESARTAN BMS
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO IRBESARTAN BMS
Do not take Irbesartan BMS if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding
Ne jemljite zdravila Irbesartan BMS če ste alergični na (preobčutljivi za) irbesartan ali katerokoli sestavino zdravila Irbesartan BMS če ste noseči že več kot tri mesece (glejte poglavje Nosečnost in dojenje) če dojite
Irbesartan BMS is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Uporaba zdravila Irbesartan BMS ni priporočljiva v zgodnjem obdobju nosečnosti, po tretjem mesecu nosečnosti pa lahko povzroči resno škodo vašemu otroku (glejte poglavje Nosečnost in dojenje).
88 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
88 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Usually, your doctor will advise you to take another medicine instead of Irbesartan BMS, as Irbesartan BMS is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Zdravnik vam bo praviloma svetoval jemanje drugega zdravila namesto zdravila Irbesartan BMS, saj jemanje zdravila Irbesartan BMS v zgodnjem obdobju nosečnosti ni priporočljivo in lahko po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
Appropriate antihypertensive drug must usually replace Irbesartan BMS before starting a pregnancy.
V primeru načrtovanja nosečnosti je treba praviloma preiti na drugo vrsto zdravljenja proti zvišanemu krvnemu tlaku.
The product should not be used during the 2nd and 3rd trimester of pregnancy, or while breast-feeding.
Zdravila Irbesartan BMS ne smete jemati v drugem in tretjem trimesečju nosečnosti ali če dojite.
Your doctor will normally advise you to stop taking Irbesartan BMS as soon as you know you are pregnant.
Zdravnik vam bo praviloma svetoval, da prekinete z jemanjem zdravila Irbesartan BMS takoj, ko izveste, da ste noseči.
If you become pregnant during therapy with Irbesartan BMS, please inform and see your doctor without delay.
Če zanosite med zdravljenjem z zdravilom Irbesartan BMS, takoj obvestite svojega zdravnika.
Method of administration Irbesartan BMS is for oral use.
Način uporabe Zdravilo Irbesartan BMS je potrebno zaužiti.
89 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
89 Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (štiri tablete) enkrat na dan.
Children should not take Irbesartan BMS Irbesartan BMS should not be given to children under 18 years of age.
Otroci ne smejo jemati zdravila Irbesartan BMS Otroci in mladostniki, mlajši od 18 let, zdravila Irbesartan BMS ne smejo jemati.
If you forget to take Irbesartan BMS If you accidentally miss a daily dose, just take the next dose as normal.
Če ste pozabili vzeti zdravilo Irbesartan BMS Če ste pozabili vzeti dnevni odmerek, vzemite le naslednji predvideni odmerek ob običajnem času.
These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Ti neželeni učinki so: glavobol, motnje okušanja, zvonjenje v ušesih, mišični krči, bolečine v sklepih in mišicah, nenormalno delovanje jeter, zvišane vrednosti
90 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Irbesartan BMS contains The active substance is irbesartan.
Kaj vsebuje zdravilo Irbesartan BMS Zdravilna učinkovina je irbesartan.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Na eni strani imajo vtisnjeno srce, na drugi pa vrezano številko 2771.
91 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
92 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
92 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
93 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
INFORMATION FOR THE USER Irbesartan BMS 150 mg tablets irbesartan
94 NAVODILO ZA UPORABO Irbesartan BMS 150 mg tablete irbesartan
94 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
95 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
95 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
96 Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (dve tableti) enkrat na dan.
96 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Na eni strani imajo vtisnjeno srce, na drugi pa vrezano številko 2772.
98 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
99 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
INFORMATION FOR THE USER Irbesartan BMS 300 mg tablets irbesartan
101 NAVODILO ZA UPORABO Irbesartan BMS 300 mg tablete irbesartan
101 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
102 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
102 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
103 Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg enkrat na dan.
103 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Na eni strani imajo vtisnjeno srce, na drugi pa vrezano številko 2773.
105 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
106 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
106 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
107 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
INFORMATION FOR THE USER Irbesartan BMS 75 mg film-coated tablets irbesartan
108 NAVODILO ZA UPORABO Irbesartan BMS 75 mg filmsko obložene tablete irbesartan
108 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
109 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
109 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
110 Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (štiri tablete) enkrat na dan.
If you accidentally take too many tablets, contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Irbesartan BMS, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
If you accidentally miss a daily dose, just take the next dose as normal.
Če ste pozabili vzeti zdravilo Irbesartan BMS Če ste pozabili vzeti dnevni odmerek, vzemite le naslednji predvideni odmerek ob običajnem času.
110 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Na eni strani imajo vtisnjeno srce, na drugi pa vrezano številko 2871.
111 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
113 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
112 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
114 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
INFORMATION FOR THE USER Irbesartan BMS 150 mg film-coated tablets irbesartan
115 NAVODILO ZA UPORABO Irbesartan BMS 150 mg filmsko obložene tablete irbesartan
114 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
116 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
115 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
117 Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (dve tableti) enkrat na dan.
116 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Na eni strani imajo vtisnjeno srce, na drugi pa vrezano številko 2872.
118 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
120 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
119 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
121 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
INFORMATION FOR THE USER Irbesartan BMS 300 mg film-coated tablets irbesartan
122 NAVODILO ZA UPORABO Irbesartan BMS 300 mg filmsko obložene tablete irbesartan
121 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
123 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
122 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
124 Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg enkrat na dan.
123 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Na eni strani imajo vtisnjeno srce, na drugi pa vrezano številko 2873.
125 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
127 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
126 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
128 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
127
129
It is available as oval tablets (peach:
Zdravilo je na voljo v obliki ovalnih tablet (breskove barve:
Irbesartan Hydrochlorothiazide BMS is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on 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 BMS has not been tested in patients below 18 years of age.
Uporaba zdravila Irbesartan Hydrochlorothiazide BMS pri bolnikih, mlajših od 18 let, še ni bila preizkušena.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Irbesartan z blokiranjem receptorjev, na katere se angiotenzin II običajno veže, zavira delovanje tega hormona, kar privede do razširitve krvnih žil.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Deluje tako, da poveča izločanje seča, zaradi česar se zmanjša količina tekočine v telesu in zniža krvni tlak.
By lowering the blood pressure, the risk of damage caused by high blood pressure, such as having a stroke, is reduced.
Z znižanjem krvnega tlaka se zmanjša tveganje za poškodbe, ki jih povzroča visok krvni tlak, kot je denimo kap.
The studies of Karvea/ Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide BMS.
V podporo uporabi zdravila Irbesartan Hydrochlorothiazide BMS so bile uporabljene študije z zdraviloma Karvea/ Aprovel, uporabljenima skupaj z hidroklorotiazidom v ločenih tabletah.
The most common side effects with Irbesartan Hydrochlorothiazide BMS (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 muscle).
Najpogostejši neželeni učinki zdravila Irbesartan Hydrochlorothiazide BMS (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).
Irbesartan Hydrochlorothiazide BMS 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 BMS 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.
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide BMS’ 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 BMS pri zdravljenju esencialne hipertenzije pri bolnikih, pri katerih samo z irbesartanom ali samo s hidroklorotiazidom ni mogoče ustrezno uravnati krvnega tlaka, večje od z njim povezanih tveganj.
The Committee recommended that Irbesartan Hydrochlorothiazide BMS be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Irbesartan Hydrochlorothiazide BMS odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Hydrochlorothiazide BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Hydrochlorothiazide BMS, veljavno po vsej Evropski uniji, odobrila družbi Bristol- Myers Squibb Pharma EEIG dne 19. januarja 2007.
Blister (PVC/ PVDC/ Alu)
Pretisni omot (PVC/ PVDC/ aluminijski)
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg tablets.
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12, 5 mg tablete
26.65 mg of lactose monohydrate per tablet.
26, 65 mg laktoze monohidrata na tableto.
Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Tablete so breskove barve, bikonveksne in ovalne oblike, na eni strani imajo vtisnjeno obliko srca, na drugi pa vrezano številko 2775.
This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Ta fiksna kombinacija je namenjena bolnikom pri katerih krvni tlak ni primerno urejen ob uporabi irbesartana ali hidroklorotiazida samega (glejte poglavje 5. 1).
Irbesartan Hydrochlorothiazide BMS 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 BMS 300 mg/ 12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg.
Zdravilo Irbesartan Hydrochlorothiazide BMS 300 mg/ 12, 5 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem s 300 mg irbesartana ali z zdravilom Irbesartan Hydrochlorothiazide BMS 150 mg/ 12, 5 mg ni dovolj znižal.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg.
Zdravilo Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem z zdravilom Irbesartan Hydrochlorothiazide BMS 300 mg/ 12, 5 mg ni dovolj znižal.
When necessary, Irbesartan Hydrochlorothiazide BMS may be administered with another antihypertensive medicinal product (see section 4.5).
Kadar je nujno, smejo bolniki poleg zdravila Irbesartan Hydrochlorothiazide BMS jemati tudi drug antihipertenziv (glejte poglavje 4. 5).