natgillin/translations-raw huggingface dataset:
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Učinki, označeni z zvezdico (*), se nanašajo na neželene učinke, o katerih so dodatno poročali pri več kot 2% diabetičnih bolnikov z visokim krvnim tlakom s kroničnim ledvičnim odpovedovanjem in izraženo proteinurijo ter večjim deležem kot pri placebu.
The frequency of adverse reactions listed below is defined using the following convention: 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).
Pogostost v nadaljevanju naštetih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000).
Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Hiperkaliemija * se je pogosteje pojavljala pri diabetičnih bolnikih, zdravljenih z irbesartanom, kot pri bolnikih, ki so dobivali placebo.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Pri diabetičnih bolnikih z visokim krvnim tlakom z mikroalbuminurijo in normalno ledvično funkcijo se je hiperkaliemija (≥ 5, 5 mEq/ l) pojavila pri 29, 4% bolnikov, ki so prejemali 300 mg irbesartana, in pri 22% bolnikov v skupini, ki je dobivala placebo.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Pri diabetičnih bolnikih z visokim krvnim tlakom s kroničnim ledvičnim odpovedovanjem in izraženo proteinurijo se je hiperkaliemija (≥ 5, 5 mEq/ l) pojavila pri 46, 3% bolnikov, ki so dobivali irbesartan, in pri 26, 3% bolnikov, ki je dobivala placebo.
significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
Pri bolnikih, zdravljenih z irbesartanom, so pogosto (1, 7%) opazili pomembno povečanje plazemske kreatininske kinaze.
None of these increases were associated with identifiable clinical musculoskeletal events.
Nobeno od teh povečanj ni bilo povezano s prepoznavnimi kliničnimi mišično- skeletnimi pojavi.
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 observed.
Pri 1, 7% bolnikov z visokim krvnim tlakom z napredovalo diabetično ledvično boleznijo, ki so jih zdravili z irbesartanom, so opazili zmanjšanje vrednosti hemoglobina *, ki pa ni bilo klinično pomembno.
Uncommon: tachycardia
Občasni: tahikardija.
dizziness, orthostatic dizziness*
Pogosti: omotica, ortostatska omotica *.
Uncommon: cough
Občasni: kašelj.
Common:
Pogosti: slabost in/ ali bruhanje.
Uncommon: diarrhoea, dyspepsia/ heartburn
Občasni: driska, dispepsija in/ ali zgaga.
Common:
Pogosti: mišično- skeletna bolečina *.
orthostatic hypotension*
Pogosti: ortostatska hipotenzija *.
Uncommon: flushing
Občasni: rdečica.
Common:
Pogosti: utrujenost.
Uncommon: chest pain
Občasni: bolečina v prsih.
6 Reproductive system and breast disorders:
6 Motnje reprodukcije in dojk:
Uncommon: sexual dysfunction
Občasni: spolne motnje.
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:
Po pridobitvi dovoljenja za promet so poročali o naslednjih dodatnih neželenih učinkih, ki izhajajo iz spontanih poročil, zato je pogostost teh neželenih učinkov neznana.
Impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Oslabljeno ledvično delovanje, vključno s primeri ledvične odpovedi pri ogroženih bolnikih (gl. poglavje 4. 4).
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle Cramps
Artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatinske kinaze v plazmi), mišični krči.
Hypersensitivity reactions such as angioedema, rash, urticaria
Preobčutljivostne reakcije, kot so angioedem, izpuščaj, koprivnica.
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%).
Med randomiziranim preizkušanjem, v katerem je sodelovalo 318 hipertenzivnih otrok in mladostnikov, starih od 6 do 16 let, so se med tritedensko dvojno slepo fazo pojavili naslednji neželeni dogodki: glavobol (7, 9%), hipotenzija (2, 2%), omotica (1, 9%), kašelj (0, 9%).
In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Med 26 - tedenskim odprtim obdobjem tega preizkušanja so bila najpogostejša laboratorijska odstopanja povečane koncentracije kreatinina (6, 5%) in povečane vrednosti kreatinske kinaze (2%).
Experience in adults exposed to doses of up to 900 mg/ day for 8 weeks revealed no toxicity.
Pri odraslih, ki so bili 8 tednov izpostavljeni odmerkom do 900 mg/ dan, niso odkrili toksičnosti.
No specific information is available on the treatment of overdosage with Irbesartan Krka.
Specifični podatki o zdravljenju preodmerjanja z Irbesartanom Krka niso na voljo.
Suggested measures include induction of emesis and/ or gastric lavage.
Priporočeni ukrepi so tudi sprožitev bruhanja in/ ali izpiranje želodca.
C09CA04.
5. 1 Farmakodinamične lastnosti
7 Mechanism of action:
C09CA04.
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Mehanizem delovanja Irbesartan je močan peroralno delujoč selektivni antagonist receptorjev za angiotenzin II (tip AT1).
Hypertension Irbesartan lowers blood pressure with minimal change in heart rate.
Hipertenzija Irbesartan znižuje krvni tlak ob minimalni spremembi srčnega utripa.
Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i. e.
Dnevni odmerki od 150 do 300 mg pri bolnikih, ki so jim krvni tlak merili v ležečem ali sedečem položaju, so 24 ur po odmerku znižali sistolični oz. diastolični krvni tlak za 8 do 13 oz.
24 hours after dosing) by an average of 8-13/ 5-8 mm Hg (systolic/ diastolic) greater than those associated with placebo.
5 do 8 mm Hg več, kot se je znižal pri bolnikih v placebo skupini.
At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
Po 24 urah je znižanje krvnega tlaka še vedno znašalo 60 do 70% največjega diastoličnega in sistoličnega odziva na priporočeni odmerek.
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Dnevni odmerek po 150 mg povzroči podobne 24- urne vrednosti in srednje vrednosti 24- urnega krvnega tlaka, kot če isti dnevni odmerek damo v dveh odmerkih.
In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/ 3-6 mm Hg (systolic/ diastolic).
3 do 6 mm Hg (sistoličnega oz. diastoličnega).
As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Podobno kot velja za druga zdravila, ki delujejo na renin- angiotenzinski sistem, se temnopolti bolniki z visokim krvnim tlakom izrazito slabše odzivajo na monoterapijo z irbesartanom.
When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e. g.
Če ti bolniki sočasno z irbesartanom jemljejo še majhen odmerek hidroklorotiazida (npr.
12.5 mg daily), the antihypertensive response in black patients approaches that of white patients.
12, 5 mg/ dan), se njihov antihipertenzivni odziv približa odzivu belcev.
Reduction of blood pressure with 0.5 mg/ kg (low), 1.5 mg/ kg (medium) and 4.5 mg/ kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Znižanje krvnega tlaka s ciljnimi titracijskimi odmerki po 0, 5 mg/ kg (majhen odmerek), 1, 5 mg/ kg (srednji odmerek) in 4, 5 mg/ kg (velik odmerek) irbesartana so po tritedenskem obdobju ocenili pri 318 ogroženih otrocih in mladostnikih, starih od 6 do 16 let (diabetes, družinska anamneza hipertenzije).
At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose).
Po koncu tritedenskega obdobja se je primarna spremenljivka učinkovitosti – najnižji sistolični krvni tlak, izmerjen sede – v primerjavi z izhodiščem znižala za povprečno 11, 7 mm Hg (pri majhnem odmerku), 9, 3 mm Hg (pri srednjem odmerku) oz.
Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows:
5, 6 mm Hg (pri velikem odmerku).
3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
Tistim, ki so dobivali placebo, se je sistolični krvni tlak v sedečem položaju zvišal za 2, 4 mm Hg, diastolični pa za 2 mm Hg.
Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Bolnikom, ki so dobivali majhen, srednji ali velik odmerek irbesartana, se je sistolični krvni tlak v sedečem položaju spremenil za +0, 1 mm Hg, diastolični pa za – 0, 3 mm Hg (gl. poglavje 4. 2).
Hypertension and type 2 diabetes with renal disease The “ Irbesartan Diabetic Nephropathy Trial (IDNT )” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Hipertenzija in sladkorna bolezen tipa 2 z ledvično boleznijo
8 disease and all-cause mortality were examined.
8 Klinično preizkušanje irbesartana pri diabetični nefropatiji (Irbesartan Diabetic Nephropathy Trial, IDNT) je pokazalo, da irbesartan pri bolnikih s kronično ledvično boleznijo in izraženo proteinurijo zmanjša napredovanje ledvične bolezni.
Patients were titrated from 75 mg to a maintenance dose of 300 mg irbesartan, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Odmerek irbesartana so jim postopoma povečevali od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina pa od 2, 5 do 10 mg oz. odmerek placeba glede na to, koliko so ga prenesli.
Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e. g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/ 85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Bolniki v vseh zdravljenih skupinah so običajno jemali 2 do 4 antihipertenzive (diuretike, zaviralce adrenergičnih receptorjev beta, zaviralce adrenergičnih receptorjev alfa), da so dosegli ciljni krvni tlak: ≤ 135/ 85 mm Hg ali znižanje krvnega tlaka za najmanj 10 mm Hg, če je bil začetni krvni tlak > 160 mm Hg.
Sixty per cent (60%) of patients in the placebo group reached this target blood pressure whereas this figure was 76% and 78% in the irbesartan and amlodipine groups respectively.
V placebo skupini je ciljni krvni tlak doseglo 60% bolnikov, v skupini, ki se je zdravila z irbesartanom, 76%, v skupini, ki je jemala amlodipin, pa 78%.
Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
V skupini, ki je jemala irbesartan, je glavni opazovani dogodek doseglo približno 33% bolnikov, v placebo skupini 39%, v skupini, ki se je zdravila z amlodipinom, pa 41% (20- odstotno relativno zmanjšanje tveganja v primerjavi s placebom, p = 0, 024; 23- odstotno relativno zmanjšanje tveganja v primerjavi z amlodipinom, p = 0, 006).
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it.
26% celotne preiskovane populacije, ni bila dokazana koristnost irbesartana za ledvice, čeprav je meje zaupanja ne izključujejo.
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
V sekundarnem izidu fatalnih in nefatalnih srčno- žilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo v primerjavi s placebo skupino opaziti povečano pogostost nefatalnih miokardnih infarktov (MI) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini, ki se je zdravila z irbesartanom.
The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preizkušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom in diabetesom tipa 2 (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus, IRMA 2) je pokazalo, da 300 mg irbesartana pri bolnikih z mikroalbuminurijo upočasni napredovanje v proteinurijo.
IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/ day) and normal renal function (serum creatinine ≤ 1.5 mg/ dl in males and < 1.1 mg/ dl in females).
IRMA 2 je bila dvojno slepa s placebom kontrolirana raziskava, v kateri so spremljali smrtnost pri 590 bolnikih z diabetesom tipa 2, mikroalbuminurijo (30 do 300 mg/ dan) in normalno ledvično funkcijo (serumski kreatinin pri moških ≤ 1, 5 mg/ dl, pri ženskah < 1, 1 mg/ dl).
The study examined the long-term effects (2 years) of irbesartan 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).
V raziskavi so proučevali dolgotrajne učinke (2 leti) irbesartana na napredovanje mikroalbuminurije v klinično proteinurijo (hitrost izločanja albuminov s sečem - “ urinary albumin excretion rate ” - UAER > 300 mg/ dan in povečanje UAER za najmanj 30% začetne vrednosti).
The predefined blood pressure goal was ≤ 135/ 85 mmHg.
Ciljni krvni tlak je bil ≤ 135/ 85 mmHg.
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Medtem, ko so v vseh skupinah dosegli podoben krvni tlak, je imelo v skupini, ki je jemala 300 mg irbesartana (5, 2%), izraženo proteinurijo manj oseb kot v placebo skupini (14, 9%) ali v skupini, ki je jemala irbesartan 150 mg (9, 7%).
An accompanying improvement in the glomerular filtration rate (GFR) was not observed during the first three months of treatment.
To pomeni 70- odstotno relativno zmanjšanje tveganja v primerjavi s placebom (p = 0, 0004) pri večjem odmerku.
Regression to normoalbuminuria (< 30 mg/ day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
V skupini, ki je jemala 300 mg irbesartana, je bila regresija na normoalbuminurijo (< 30 mg/ dan) pogostejša (34%) kot v placebo skupini (21%).
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Irbesartan se po peroralni uporabi dobro absorbira; študije so pokazale 60 - do 80- odstotno absolutno biološko uporabnost.
Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Vezava na plazemske beljakovine je približno 96- odstotna, vezava na krvne celice pa zanemarljiva.
Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Po peroralni ali intravenski uporabi 14C irbesartana prispeva 80 do 85% radioaktivnosti v plazemskem obtoku nespremenjeni irbesartan.
The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Glavni presnovek v obtoku je irbesartan glukuronid (približno 6%).
9 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 (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Pri odmerkih, ki so večji od 600 mg (dvakrat več od priporočenega odmerka), so opazili nesorazmerno majhno povečanje peroralne absorpcije; mehanizem tega pojava ni pojasnjen.
Peak plasma concentrations are attained at 1.5-2 hours after oral administration.
Največje plazemske koncentracije doseže 1, 5 do 2 uri po peroralni uporabi.
The total body and renal clearance are 157-176 and 3-3.5 ml/ min, respectively.
3 do 3, 5 ml/ min.
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Kopičenje irbesartana v plazmi (< 20%) so opazili pri ponavljajočem odmerjanju zdravila enkrat na dan.
However, there was no difference in the half-life and accumulation of irbesartan.
V raziskavi so opazili nekoliko večjo koncentracijo irbesartana pri bolnicah z visokim krvnim tlakom, razlike v razpolovnem času in kopičenju irbesartana pa ni bilo.
However the terminal halflife was not significantly altered.
Vrednosti AUC in maksimalna koncentracija irbesartana so bile pri starejših osebah (≥ 65 let) nekoliko večje kot pri mlajših (18 do 40 let), pomembnih sprememb končnega razpolovnega časa pa ni bilo.
After either oral or IV administration of 14C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Po peroralnem ali intravenskem dajanju 14C irbesartana se približno 20% radioaktivnosti izloči s sečem, preostanek pa z blatom.
Less than 2% of the dose is excreted in the urine as unchanged irbesartan.
Manj kot 2% odmerka irbesartana se v nespremenjeni obliki izloči s sečem.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Farmakokinetiko irbesartana so štiri tedne ugotavljali pri 23 hipertenzivnih otrocih tako po enkratnem kot po večkratnih manjših dnevnih odmerkih irbesartana (2 mg/ kg) do največjega dnevnega odmerka 150 mg.
A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing.
Po ponavljajočem odmerjanju enkrat na dan so ugotovili kopičenje irbesartana v plazmi (18%).
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
V nekliničnih raziskavah o varnosti so veliki odmerki irbesartana (≥ 250 mg/ kg/ dan pri podganah in ≥ 100 mg/ kg/ dan pri opicah makako) povzročili zmanjšanje števila eritrocitov, koncentracij hemoglobina in hematokrita.
At very high doses (≥ 500 mg/ kg/ day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Zelo veliki odmerki irbesartana (≥ 500 mg/ kg/ dan) so pri podganah in opicah makako sprožili degenerativne spremembe v ledvicah (kot so intersticijski nefritis, razširitev tubulov, bazofilni tubuli, povečana plazemska koncentracija sečnine in kreatinina), za katere domnevajo, da so posledica hipotenzivnega učinka zdravila, ki povzroči zmanjšani pretok v ledvicah.
Furthermore, irbesartan induced hyperplasia/ hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/ kg/ day, in macaques at ≥ 10 mg/ kg/ day).
Poleg tega je irbesartan sprožil hiperplazijo/ hipertrofijo jukstaglomerulnih celic (pri podganah pri ≥ 90 mg/ kg/ dan, pri opicah makako pri ≥ 10 mg/ kg/ dan).
For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Kaže, da je hiperplazija/ hipertrofija ledvičnih jukstaglomerulnih celic pri človeku, ki jemlje terapevtske odmerke, nepomembna.
There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
10 O mutagenosti, klastogenosti ali karcinogenosti ni nobenih dokazov.
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Poskusi na živalih z irbesartanom so pri podganjih zarodkih pokazali prehodne toksične učinke (povečanje ledvično- medenične votline, razširjen sečevod ali podkožne edeme), ki so izginili po rojstvu.
10 6.1 List of excipients
6. 1 Seznam pomožnih snovi
Mannitol Hydroxypropylcellulose Low-substituted Hydroxypropyl Cellulose (LH-21) Low-substituted Hydroxypropyl Cellulose (LH-11) Talc Macrogol 6000 Castor oil, hydrogenated
Jedro tablete manitol hidroksipropilceluloza nizkosubstituirana hidroksipropilceluloza (LH- 21) nizkosubstituirana hidroksipropilceluloza (LH- 11) smukec makrogol 6000 hidrogenirano ricinusovo olje
Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3000 Talc
Filmska obloga polivinilalkohol titanov dioksid (E 171) makrogol 3000 smukec
Blister pack (PVC/ PE/ PVDC, Al-foil):
Pretisni omot (PVC/ PE/ PVDC folija, Al- folija):
14, 28, 56, 84 or 98 film-coated tablets in box are available.
14, 28, 56, 84 ali 98 filmsko obloženih tablet, v škatli.
56 x 1 film-coated tablets in perforated unit dose blisters in box.
56 x 1 filmsko obloženih tablet v perforiranih pretisnih omotih, v škatli.
KRKA, d. d., Novo mesto, Š marješ ka cesta 6, 8501 Novo mesto, Slovenia
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
< Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Irbesartan Krka 150 mg film-coated tablets
Irbesartan Krka 150 mg filmsko obložene tablete
White, oval tablets.
150 mg: bele barve, ovalne oblike.
Elderly patients:
13 Starejši bolniki:
12 Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Čeprav je treba pri bolnikih, ki so starejši od 75 let, pretehtati možnost uporabe začetnega odmerka po 75 mg, prilagajanje odmerka običajno ni potrebno.
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).
Pediatrični bolniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba irbesartana pri otrocih in mladostnikih ni priporočljiva (gl. poglavja 4. 8, 5. 1 in 5. 2).