FrancophonIA/ELRC3.0 huggingface dataset:
English: On 08 April 2015, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Duloxetine Sandoz, for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.
Slovenian: Družba Sandoz GmbH je 4. aprila 2015 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Duloxetine Sandoz, namenjenim zdravljenju depresije, diabetične periferne nevropatije in generalizirane anksiozne motnje.
English: The active substance in Duloxetine Sandoz, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Duloxetine Sandoz, duloksetin, je zaviralec ponovnega prevzema serotonina in noradrenalina.
English: Duloxetine Sandoz is a medicine that contains the active substance duloxetine.
Slovenian: Duloxetine Sandoz je zdravilo, ki vsebuje zdravilno učinkovino duloksetin.
English: What is Duloxetine Sandoz?
Slovenian: Kaj je zdravilo Duloxetine Sandoz?
English: What was Duloxetine Sandoz expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Duloxetine Sandoz uporabljalo?
English: How is Duloxetine Sandoz expected to work?
Slovenian: Kako naj bi zdravilo Duloxetine Sandoz delovalo?
English: 56 x 1 tablets:
Slovenian: 56 x 1 tablet:
English: (It is also better to avoid Irbesartan BMS in early pregnancy - see pregnancy section)
Slovenian: (Jemanju zdravila Irbesartan BMS se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti)
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 January 2007
Slovenian: DATUM PRIDOBITVE /PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 19. januar 2007
English: Uxbridge UB8 1DH - United Kingdom
Slovenian: Uxbridge UB8 1DH - Velika Britanija
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/
English: The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3.0, predstavljeni v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: The active substance is irbesartan.
Slovenian: Zdravilna učinkovina je irbesartan.
English: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000).
Slovenian: Pogostnost spodaj naštetih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100, <1/10); občasni (≥1/1.000, <1/100); redki (≥1/10.000, <1/1.000); zelo redki (<1/10.000).
English: The following additional adverse reactions have been reported during post-marketing experience; they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known:
Slovenian: Po pridobitvi dovoljenja za promet so poročali o naslednjih dodatnih neželenih učinkih, ki izhajajo iz spontanih poročil, zato je pogostnost teh neželenih učinkov neznana:
English: Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Slovenian: Artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatin-kinaze v plazmi), mišični krči
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).
Slovenian: Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥65 let) nekoliko večje kot pri mlajših (18-40 let).
English: Do not take Irbesartan BMS if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS if you are more than 3 months pregnant.
Slovenian: Ne jemljite zdravila Irbesartan BMS če ste alergični na (preobčutljivi za) irbesartan ali katerokoli sestavino zdravila Irbesartan BMS če ste noseči dlje kot tri mesece.
English: Paediatric patients: in a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following related adverse events occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Slovenian: Pediatrični bolniki: Med randomiziranim preskušanjem pri 318 hipertenzivnih otrocih in mladostnikih, starih od 6 do 16 let, so se med 3-tedensko dvojno slepo fazo pojavili naslednji neželeni dogodki: glavobol (7,9%), hipotenzija (2,2%), omotica (1,9%), kašelj (0,9%).
English: Irbesartan BMS should not be given to children and adolescents (under 18 years).
Slovenian: Zdravila Irbesartan BMS ne smejo jemati otroci in mladostniki (mlajši od 18 let).
English: It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.
Slovenian: Pomembno je, da zdravilo Irbesartan BMS jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
English: Irbesartan BMS belongs to a group of medicines known as angiotensin-II receptor antagonists.
Slovenian: Zdravilo Irbesartan BMS spada v skupino zdravil, ki so znana kot antagonisti angiotenzina-II.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO IRBESARTAN BMS IN ZA KAJ GA UPORABLJAMO
English: Take special care with Irbesartan BMS Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Irbesartan BMS for diabetic kidney disease.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Irbesartan BMS Obvestite svojega zdravnika, če se karkoli od naslednjega nanaša na vas: če začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami če imate težave s srcem če zdravilo Irbesartan BMS jemljete zaradi diabetične bolezni ledvic.
English: The study examined the long-term effects (2 years) of Irbesartan BMS on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Slovenian: V raziskavi so proučevali dolgotrajne učinke (2 leti) zdravila Irbesartan BMS na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom -“urinary albumin excretion rate”-UAER >300 mg/dan in povečanje UAER-a najmanj za 30% začetne vrednosti).
English: Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom
Slovenian: Newcastle Upon Tyne, Tyne & Wear NE3 3TT - Velika Britanija
English: Renal impairment and kidney transplantation: when Irbesartan BMS is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Slovenian: Ledvična okvara in presaditev ledvic: pri dajanju zdravila Irbesartan BMS bolnikom s prizadeto ledvično funkcijo se priporoča redno nadzorovanje ravni kalija in kreatinina v serumu.
English: If you have any further questions, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja, se posvetujete z zdravnikom ali s farmacevtom.
English: Newcastle Upon Tyne, Tyne & Wear NE3 3TT United Kingdom
Slovenian: Newcastle Upon Tyne, Tyne & Wear NE3 3TT Velika Britanija
English: Like all medicines, Irbesartan BMS can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Irbesartan BMS neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Irbesartan BMS at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Slovenian: Na splošno zagotavlja odmerek 150 mg zdravila Irbesartan BMS enkrat na dan boljši 24 urni nadzor krvnega tlaka kot 75 mg.
English: Taking Irbesartan BMS with food and drink Irbesartan BMS can be taken with or without food.
Slovenian: Jemanje zdravila Irbesartan BMS skupaj s hrano in pijačo Zdravilo Irbesartan BMS lahko jemljete s hrano ali brez nje.
English: What Irbesartan BMS is and what it is used for Before you take Irbesartan BMS How to take Irbesartan BMS Possible side effects
Slovenian: Kaj je zdravilo Irbesartan BMS in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Irbesartan BMS Kako jemati zdravilo Irbesartan BMS Možni neželeni učinki
English: While this is not documented with Irbesartan BMS, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Slovenian: Čeprav to za zdravilo Irbesartan BMS ni dokazano, je treba podobne učinke pričakovati pri antagonistih receptorjev za angiotenzin II.
English: C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Slovenian: prispeva 80-85% radioaktivnosti v plazemskem obtoku nespremenjeni irbesartan.
English: If you get any of these symptoms or get short of breath, stop taking Irbesartan BMS and contact your doctor immediately.
Slovenian: Če opazite kateregakoli od teh simptomov ali se pojavi občutek težkega dihanja, zdravilo Irbesartan BMS takoj prenehajte uporabljati in nemudoma poiščite zdravniško pomoč.
English: You can take Irbesartan BMS with or without food.
Slovenian: Zdravilo Irbesartan BMS lahko jemljete s hrano ali brez nje.
English: No specific information is available on the treatment of overdose with Irbesartan BMS.
Slovenian: Specifični podatki o zdravljenju prevelikega odmerjanja z zdravilom Irbesartan BMS niso na voljo.
English: 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).
Slovenian: Ti neželeni učinki so: glavobol, motnje okušanja, zvonjenje v ušesih, mišični krči, bolečine v sklepih in mišicah, nenormalno delovanje jeter, zvišane vrednosti kalija v krvi, okvara delovanja ledvic in vnetje malih krvnih žil, predvsem kože (bolezen, znana kot levkocitoklastični vaskulitis).
English: Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).
Slovenian: Zdravljenje ledvične bolezni pri bolnikih s hipertenzijo in diabetesom tipa 2, kot del antihipertenzivnega režima zdravljenja z zdravili (glejte poglavje 5.1).
English: If you take more Irbesartan BMS than you should If you accidentally take too many tablets, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Irbesartan BMS, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
Slovenian: IDNT je bilo dvojno slepo, kontrolirano preskušanje vpliva zdravila Irbesartan BMS na obolevnost in smrtnost v primerjavi z amlodipinom in placebom.
English: The blood pressure lowering effect of Irbesartan BMS is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Slovenian: Učinek zdravila Irbesartan BMS na znižanje krvnega tlaka je viden po 1-2 tednih, največji učinek pa nastopi 4-6 tednov po začetku zdravljenja.
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan BMS, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Slovenian: Bolnikom so postopoma povečevali odmerek zdravila Irbesartan BMS od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina od 2,5 do 10 mg, oziroma placeba, kot so ga prenesli.
English: Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Slovenian: Zdravilo Irbesartan BMS preprečuje vezavo angiotenzina-II na te receptorje in tako sprošča krvne žile ter znižuje krvni tlak.
English: Important information about some of the ingredients of Irbesartan BMS Irbesartan BMS contains lactose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Irbesartan BMS Zdravilo Irbesartan BMS vsebuje laktozo.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Irbesartan BMS 300 mg group (34%) than in the placebo group (21%).
Slovenian: V skupini s 300 mg zdravila Irbesartan BMS je bila pogostejša (34%) regresija na normoalbuminurijo (<30 mg/dan), kot v placebo skupini (21%).
English: Paediatric patients: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Slovenian: Pediatrični bolniki: irbesartan so raziskovali pri pediatričnih bolnikih, starih od 6 do 16 let, vendar trenutni podatki ne zadoščajo za podporo podaljšane uporabe pri otrocih, dokler ne bo na voljo dodatnih podatkov (glejte poglavja 4.8, 5.1 in 5.2).
English: Therefore, the use of Irbesartan BMS is not recommended.
Slovenian: Zato uporaba zdravila Irbesartan BMS ni priporočljiva.
English: Do not use Irbesartan BMS after the expiry date which is stated on the carton and on the blister after EXP.
Slovenian: Zdravila Irbesartan BMS ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake "Upor.
English: Paediatric patients: irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.8, 5.1 and 5.2).
Slovenian: Pediatrični bolniki: Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba irbesartana pri otrocih in mladostnikih ni priporočljiva (glejte poglavja 4.8, 5.1 in 5.2).
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan BMS (see section 4.4).
Slovenian: Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Irbesartan BMS (glejte poglavje
English: LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: vsebuje tudi laktozo monohidrat.
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan BMS, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Slovenian: Hiperkaliemija: kot pri drugih zdravilih, ki vplivajo na sistem renin-angiotenzin-aldosteron, se lahko tudi med zdravljenjem z zdravilom Irbesartan BMS pojavi hiperkaliemija, zlasti ob prisotnosti ledvične okvare, izrazite proteinurije zaradi diabetične ledvične bolezni in/ali odpovedi srca.
English: In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been
Slovenian: Pri 1,7% bolnikov z visokim krvnim tlakom z napredovalo diabetično ledvično boleznijo, ki so jih zdravili z irbesartanom, so opazili znižanje hemoglobina*, ki ni
English: Your doctor will normally advise you to stop taking Irbesartan BMS before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan BMS.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Irbesartan BMS prekinete še preden zanosite ali takoj, ko se izkaže, da ste zanosili in vam predpisal zdravljenje z drugim zdravilom.
English: C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Slovenian: dajanju 14C irbesartana, se približno 20% radioaktivnosti izloči z urinom in preostanek z blatom.
English: Lithium: the combination of lithium and Irbesartan BMS is not recommended (see section 4.5).
Slovenian: Litij: sočasna uporaba zdravila Irbesartan BMS in litija ni priporočljiva (glejte poglavje 4.5).
English: Side effects reported in clinical studies for patients treated with Irbesartan BMS were: Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Slovenian: V kliničnih preskušanjih so pri bolnikih, ki so se zdravili z zdravilom Irbesartan BMS, poročali o naslednjih neželenih učinkih: Zelo pogosti: če imate visok krvni tlak in sladkorno bolezen tipa 2 z boleznijo ledvic lahko krvne preiskave pokažejo zvišanje vrednosti kalija v krvi.
English: Metabolism and nutrition disorders: Hyperkalaemia
Slovenian: Presnovne in prehranske motnje: Hiperkaliemija
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan BMS has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Slovenian: Diuretiki in drugi antihipertenzivi: drugi antihipertenzivi lahko povečajo hipotenzivni učinek irbesartana; vendar pa so zdravilo Irbesartan BMS varno uporabljali z drugimi antihipertenzivi, kot so zaviralci adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov z dolgotrajnim delovanjem in tiazidnimi diuretiki.
English: Such conditions should be corrected before the administration of Irbesartan BMS.
Slovenian: Ta stanja se mora korigirati, preden se uporabi zdravilo Irbesartan BMS.
English: The demonstration of renal benefit of Irbesartan BMS in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see section 5.1).
Slovenian: Koristi zdravljenja z zdravilom Irbesartan BMS za ledvice pri bolnikih z visokim krvnim tlakom z diabetesom tipa 2 so pokazale študije, kjer so irbesartan uporabljali dodatno z drugimi antihipertenzivi, potrebnimi za doseganje ciljnega krvnega tlaka (glejte poglavje 5.1).
English: In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan BMS (see section 4.5).
Slovenian: In sicer, se je pri dodatni uvedbi diuretika, kot je hidroklorotiazid, pokazal sinergistični učinek z zdravilom Irbesartan BMS (glejte poglavje 4.5).
English: Nervous system disorders: Headache
Slovenian: Bolezni živčevja: Glavobol
English: Irbesartan BMS does not usually interact with other medicines.
Slovenian: Zdravilo Irbesartan BMS običajno ne vpliva na delovanje drugih zdravil in obratno.
English: Irbesartan BMS is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Slovenian: Zdravila Irbesartan BMS ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo v tem obdobju resno škoduje vašemu otroku (glejte poglavje o nosečnosti).
English: Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known.
Slovenian: Po prihodu zdravila Irbesartan BMS na tržišče so poročali še o nekaterih drugih neželenih učinkih, vendar pa njihova pogostnost ni znana.
English: Immune system disorders: Hypersensitivity reactions such as angioedema, rash, urticaria
Slovenian: Bolezni imunskega sistema: Preobčutljivostne reakcije, kot so angioedem, izpuščaj, koprivnica
English: There is no experience regarding the administration of Irbesartan BMS in patients with a recent kidney transplantation.
Slovenian: Glede uporabe zdravila Irbesartan BMS pri bolnikih po nedavni presaditvi ledvic ni nobenih izkušenj.
English: Irbesartan BMS is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Zdravila Irbesartan BMS ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
English: 14 tablets 28 tablets 56 tablets 56 x 1 tablets 84 tablets 98 tablets
Slovenian: 14 tablet 28 tablet 56 tablet 56 x 1 tablet 84 tablet 98 tablet
English: In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan BMS can be increased to 300 mg, or other antihypertensive agents can be added.
Slovenian: Pri bolnikih, kjer enkratni dnevni odmerek 150 mg zdravila Irbesartan BMS ne zadošča za nadzor krvnega tlaka, se lahko odmerek poveča na 300 mg ali uvede dodatni antihipertenziv.
English: Skin and subcutaneous tissue disorders: Leukocytoclastic vasculitis
Slovenian: Bolezni kože in podkožja: Levkocitoklastični vaskulitis
English: Irbesartan BMS is unlikely to affect your ability to drive or use machines.
Slovenian: Verjetnost, da bi zdravilo Irbesartan BMS vplivalo na sposobnost upravljanja vozil ali strojev, je majhna.
English: 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets
Slovenian: 14 tablet 28 tablet 56 tablet 56 x 1 tablet 98 tablet
English: If you forget to take Irbesartan BMS
Slovenian: Če ste pozabili vzeti zdravilo Irbesartan BMS
English: How to store Irbesartan BMS Further information
Slovenian: Shranjevanje zdravila Irbesartan BMS Dodatne informacije
English: The PSUR cycle of Irbesartan BMS is aligned with the cross-referred product, KARVEA, until otherwise specified.
Slovenian: Cikel predajanja periodičnih poročil o varnosti zdravila Irbesartan BMS, je vezan na referenčno zdravilo KARVEA, dokler ni določeno drugače.
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
Slovenian: Pomožne snovi so laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, hipromeloza, silicijev dioksid, magnezijev stearat, titanov dioksid, makrogol 3000 in karnauba vosek.
English: In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Irbesartan BMS on the progression of renal disease and all-cause mortality were examined.
Slovenian: Pri 1.715 bolnikih z visokim krvnim tlakom z diabetesom tipa 2, proteinurijo ≥900 mg/dan in serumskim kreatininom 1,0-3,0 mg/dl, so raziskovali dolgotrajne učinke zdravila Irbesartan BMS (povprečje 2,6 let) na napredovanje ledvične bolezni in na celokupno smrtnost.
English: Marketing Authorisation Holder:
Slovenian: Imetnik dovoljenja za promet:
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Slovenian: Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte poglavje 5.3).