FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 20 mg COATED TABLETS: BLISTER FOIL LABEL
Slovenian: ZYPREXA 20 mg OBLOŽENE TABLETE: OZNAKA FOLIJE PRETISNEGA OMOTA
English: (Perforation to allow health care provider information to be detached) INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS Reconstitution and administration of ZYPREXA Reconstitute ZYPREXA Powder for Solution for Injection only with water for injections.
Slovenian: (Perforacija, ki omogoča, da zdravstveno osebje odtrga informacije.)
English: Thrombocytopenia11
Slovenian: Trombocitope nija11
English: Date of first authorisation: 1 December 2008 Date of latest renewal: 26 August 2013
Slovenian: Datum prve odobritve: 1. december 2008 Datum zadnjega podaljšanja: 26. avgust 2013
English: This medicine should not be used in children and adolescents (< 18 years) because the safety and efficacy have not yet been fully established.
Slovenian: Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih (< 18 let), ker varnost in učinkovitost še nista bili popolnoma ugotovljeni.
English: The volume of distribution is 53-93 litres.
Slovenian: Volumen porazdelitve je 53 do 93 litrov.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Slovenian: Bolnika je treba skrbno nadzorovati, zdravljenje pa mora biti simptomatsko in podporno.
English: - Patients with high blood pressure
Slovenian: - Bolniki z visokim krvnim tlakom
English: Some of these effects may be serious and may require medical attention.
Slovenian: Nekateri neželeni učinki so lahko hudi in lahko zahtevajo zdravniško pomoč.
English: None of these increases were associated with identifiable clinical musculoskeletal events.
Slovenian: Nobeno od teh povečanj ni bilo povezano s prepoznavnimi kliničnimi mišično-skeletnimi pojavi.
English: This results in an increase in blood pressure.
Slovenian: Posledica je zvišanje krvnega tlaka.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2 vendar priporočil o odmerjanju ni mogoče dati.
English: PVC/PE/PVDC/Alu
Slovenian: BLISTER PVC/PE/PVDC/Al
English: You can take Ifirmasta with or without food.
Slovenian: Zdravilo Ifirmasta lahko jemljete s hrano ali brez nje.
English: The safety and efficacy of Ifirmasta in children aged 0 to 18 has not been established.
Slovenian: Varnost in učinkovitost zdravila Ifirmasta pri otrocih, starih od 0 do 18 let, nista bili dokazani.
English: These adverse reactions are derived from spontaneous reports.
Slovenian: Ti neželeni učinki izhajajo iz spontanih poročil,.
English: Activated charcoal may be useful in the treatment of overdosage.
Slovenian: Aktivno oglje je lahko koristno pri zdravljenju preodmerjanja.
English: If you forget to take Ifirmasta
Slovenian: Če ste pozabili vzeti zdravilo Ifirmasta
English: It is important that you continue to take Ifirmasta until your doctor tells you otherwise.
Slovenian: Pomembno je, da zdravilo Ifirmasta jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
English: Primary aldosteronism
Slovenian: Primarni aldosteronizem:
English: Do not take Ifirmasta - if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6), - if you are more than 3 months pregnant.
Slovenian: Ne jemljite zdravila Ifirmasta: - če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste noseči dlje kot tri mesece.
English: Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity.
Slovenian: Pri odraslih, ki so bili 8 tednov izpostavljeni odmerkom do 900 mg/dan, niso odkrili toksičnosti.
English: The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Slovenian: Upočasnitev napredovanja v klinično proteinurijo je bila vidna že v prvih treh mesecih in se je nadaljevala skozi dveletno obdobje.
English: What you need to know before you take Ifirmasta
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ifirmasta
English: Additional information on irbesartan interactions:
Slovenian: Dodatni podatki o medsebojnem delovanju z irbesartanom:
English: See also information under the heading “Do not take Ifirmasta”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Ifirmasta”.
English: Ifirmasta is indicated in adults for the treatment of essential hypertension.
Slovenian: Zdravilo Ifirmasta je indicirano pri odraslih za zdravljenje esencialne hipertenzije.
English: The predefined blood pressure goal was ≤ 135/85 mmHg.
Slovenian: Ciljni krvni tlak je bil ≤ 135/85 mmHg.
English: Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Slovenian: Vezava na plazemske beljakovine je približno 96-odstotna, vezava na krvne celice pa zanemarljiva.
English: Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Slovenian: Pri 21 otrocih jo je bilo možno primerjati s farmakokinetiko pri odraslih (12 otrok je bilo starejših od 12 let, 9 otrok je bilo starih od 6 do 12 let).
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Slovenian: Pogostost v nadaljevanju naštetih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000).
English: If you experience these, talk to your doctor before attempting to drive or use machines.
Slovenian: Če se vam to dogaja, se morate posvetovati s svojim zdravnikom, preden nameravate voziti ali upravljati stroje.
English: Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Slovenian: Drugo in tretje trimesečje nosečnosti (gl. poglavji 4.4 in 4.6).
English: What Ifirmasta is and what it is used for
Slovenian: Kaj je zdravilo Ifirmasta in za kaj ga uporabljamo
English: All of these changes were considered to be caused by the pharmacological action of irbesartan.
Slovenian: Vse te spremembe naj bi bile posledica farmakološkega delovanja irbesartana.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3000
Slovenian: Filmska obloga polivinilalkohol titanov dioksid (E171) makrogol 3000 smukec
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini so neželeni učinki navedeni po padajoči resnosti.
English: The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Slovenian: Glavni presnovek v obtoku je irbesartan glukuronid (približno 6 %).
English: Other medicines and Ifirmasta
Slovenian: Druga zdravila in zdravilo Ifirmasta
English: The total body and renal clearance are 157-176 and 3-3.5 ml/min, respectively.
Slovenian: Skupni telesni in ledvični očistek je 157 do 176 oz. 3 do 3,5 ml/min.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Slovenian: Epidemiološke raziskave niso pokazale teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju nosečnosti izpostavljene zaviralcem ACE, vendar pa nekoliko povečanega tveganja ni možno izključiti.
English: However, occasionally dizziness or weariness may occur during treatment of high blood pressure.
Slovenian: Občasno se lahko med zdravljenjem visokega krvnega tlaka pojavita omotica ali utrujenost.
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Slovenian: Bolniki s primarnim aldosteronizmom se na splošno ne odzivajo na antihipertenzive, ki delujejo tako, da zavirajo sistem renin-angiotenzin.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Pharmacotherapeutic group: angiotensin II antagonist, plain, ATC code: C09CA04.
Slovenian: Farmakoterapevtska skupina: antagonisti angiotenzina II, enokomponentna zdravila, oznaka ATC: C09CA04.
English: Irbesartan does not require metabolic activation for its activity.
Slovenian: Irbesartan za svojo učinkovitost ne potrebuje metabolične aktivacije.
English: Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Slovenian: Rezultati so pokazali, da so bili maksimalna koncentracija, AUC in očistek primerljivi rezultatom pri tistih odraslih, ki so dobivali 150 mg irbesartana na dan.
English: If you take more Ifirmasta than you should If you accidentally take too many tablets, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Ifirmasta, kot bi smeli Če ste pomotoma vzeli preveč tablet, takoj pokličite svojega zdravnika.
English: (It is also better to avoid Ifirmasta in early pregnancy - see pregnancy section), - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Slovenian: (Jemanju zdravila Ifirmasta se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti), - če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
English: You may need to have blood checks if you take: - potassium supplements, - salt substitutes containing potassium, - potassium-sparing medicines (such as certain diuretics), - medicines containing lithium.
Slovenian: Morda bodo potrebne krvne preiskave, če jemljete: - dodatke kalija - nadomestke soli, ki vsebujejo kalij - zdravila, ki varčujejo s kalijem (kot so nekateri diuretiki) - zdravila, ki vsebujejo litij
English: Ifirmasta at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Slovenian: Na splošno zagotavlja 150 mg zdravila Ifirmasta enkrat na dan boljši 24-urni nadzor krvnega tlaka kot 75 mg.
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Slovenian: Irbesartan je močan peroralno delujoč selektivni antagonist receptorjev za angiotenzin II (tip AT1).
English: Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dose adjustment is not usually necessary for older people.
Slovenian: Čeprav je treba pri bolnikih, ki so starejši od 75 let, pretehtati možnost uporabe začetnega odmerka po 75 mg, prilagajanje odmerka običajno ni potrebno.
English: Irbesartan lowers blood pressure with minimal change in heart rate.
Slovenian: Irbesartan znižuje krvni tlak ob minimalni spremembi srčnega utripa.
English: Your doctor may need to change your dose and/or to take other precautions: - If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Ifirmasta” and “Warnings and precautions”).
Slovenian: Zdravnik vam bo morda moral spremeniti odmerek in/ali upoštevati druge previdnostne ukrepe: - Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila Ifirmasta" in "Opozorila in previdnostni ukrepi").
English: C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Slovenian: C irbesartana prispeva 80 do 85 % radioaktivnosti v plazemskem obtoku nespremenjeni irbesartan.
English: What Ifirmasta is and what it is used for What you need to know before you take Ifirmasta How to take Ifirmasta
Slovenian: Kaj je zdravilo Ifirmasta in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ifirmasta Kako jemati zdravilo Ifirmasta Možni neželeni učinki
English: In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Slovenian: Raziskave in vitro kažejo, da se irbesartan primarno oksidira s citokromom P450, encimom CYP2C9; izoencim CYP3A4 ima zanemarljiv učinek.
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 observed.
Slovenian: 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.
English: Diuretics and other antihypertensive agents:
Slovenian: Diuretiki in drugi antihipertenzivi:
English: In particular, they appeared less favourable in women and non-white subjects (see section 5.1).
Slovenian: Zdi se, da so manj ugodni pri ženskah in pri temnopoltih bolnikih (gl. poglavje 5.1).
English: At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
Slovenian: Po 24 urah je znižanje krvnega tlaka še vedno znašalo 60 do 70 % največjega diastoličnega in sistoličnega odziva na priporočeni odmerek.
English: The usual dose is 150 mg once a day (two tablets a day).
Slovenian: Običajni odmerek je 150 mg enkrat na dan (dve tableti).
English: Read the package leaflet before use.
Slovenian: za peroralno uporabo Pred uporabo preberite priloženo navodilo!
English: After withdrawal of therapy, blood pressure gradually returns toward baseline.
Slovenian: Po ukinitvi zdravila se krvni tlak postopoma vrne na začetno vrednost.
English: However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
Slovenian: Vendar pa je treba pretehtati možnost uvajanja zdravljenja s 75 mg, zlasti pri bolnikih na hemodializi in pri starejših od 75 let.
English: The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Slovenian: Kot posledico prevelikega odmerjanja je najverjetneje pričakovati hipotenzijo in tahikardijo, lahko pa se pojavi tudi bradikardija.
English: Blister (PVC/PE/PVDC/Alu): 56 x 1 film-coated tablets in perforated unit dose blisters in box.
Slovenian: Pretisni omot (PVC/PE/PVDC/Al): 56 x 1 filmsko obloženih tablet perforiranih blistrih, v škatli.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Slovenian: Če se pokaže, da so potrebne, priporočamo skrbno spremljanje serumske koncentracije litija.
English: 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.
Slovenian: Med 26-tedenskim odprtim obdobjem tega preizkušanja so bila najpogostejša laboratorijska odstopanja povečane koncentracije kreatinina (6,5 %) in povečane vrednosti kreatinske kinaze (2 %).
English: Concomitant food intake does not significantly influence the bioavailability of irbesartan.
Slovenian: Sočasen vnos hrane ne vpliva pomembno na biološko uporabnost irbesartana.
English: What Ifirmasta contains - The active substance is irbesartan.
Slovenian: Kaj vsebuje zdravilo Ifirmasta - Zdravilna učinkovina je irbesartan.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
Slovenian: V skupini, ki je jemala 300 mg irbesartana, je bila regresija na normoalbuminurijo (< 30 mg/dan) pogostejša (34 %) kot v placebo skupini (21 %).
English: Clinical efficacy:
Slovenian: Klinična učinkovitost
English: Ifirmasta belongs to a group of medicines known as angiotensin-II receptor antagonists.
Slovenian: Zdravilo Ifirmasta spada v skupino zdravil, ki so znana kot antagonisti angiotenzina II.
English: Ifirmasta is unlikely to affect your ability to drive or use machines.
Slovenian: Ni verjetno, da bi zdravilo Ifirmasta vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
English: Talk to your doctor or pharmacist before taking Ifirmasta and 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 Ifirmasta for diabetic kidney disease.
Slovenian: Pred začetkom jemanja uporabe zdravila Ifirmasta se posvetujte z zdravnikom ali farmacevtom, če za vas velja karkoli od spodaj navedenega: - če začnete prekomerno bruhati ali dobite hudo drisko, - če imate težave z ledvicami, - če imate težave s srcem, - če zdravilo Ifirmasta jemljete zaradi diabetične bolezni ledvic.
English: If you accidentally miss a daily dose, just take the next dose as normal.
Slovenian: Če ste odmerek pomotoma izpustili, vzemite naslednjega ob običajnem času.
English: - The other ingredients are mannitol, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000, castor oil, hydrogenated in the core of tablet and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in film-coating.
Slovenian: - Druge sestavine zdravila so manitol, hidroksipropilceluloza, nizkosubstituirana hidroksipropilceluloza, nizkosubstituirana hidroksipropilceluloza (LH-21), nizkosubstituirana hidroksipropilceluloza (LH-11), smukec, makrogol 6000, hidrogenirano ricinusovo olje v jedru tablete ter polivinilalkohol, titanov dioksid (E171), makrogol 3000 in smukec v filmski oblogi.
English: Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3%) than for placebo-treated patients (4.5%).
Slovenian: Prekinitev zaradi kateregakoli kliničnega ali laboratorijskega neželenega dogodka je bila pri bolnikih, ki so jemali irbesartan, manj pogosta (3,3 %) kot pri bolnikih, ki so dobivali placebo (4,5 %).
English: Your doctor will normally advise you to stop taking Ifirmasta before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Ifirmasta.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Ifirmasta prekinete še preden zanosite ali takoj, ko se izkaže, da ste zanosili in vam predpisal zdravljenje z drugim zdravilom.
English: Common:
Slovenian: Splošno:
English: C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Slovenian: C irbesartana se približno 20 % radioaktivnosti izloči s sečem, preostanek pa z blatom.
English: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Slovenian: Irbesartan se po peroralni uporabi dobro absorbira; raziskave so pokazale 60- do 80-odstotno absolutno biološko uporabnost.
English: Blister (PVC/PE/PVDC/Alu): 14, 28, 30, 56, 84, 90 or 98 film-coated tablets in box are available.
Slovenian: Pretisni omot (PVC/PE/PVDC/Al): 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženih tablet, v škatli.
English: Less than 2% of the dose is excreted in the urine as unchanged irbesartan.
Slovenian: Manj kot 2 % odmerka irbesartana se v nespremenjeni obliki izloči s sečem.
English: Peak plasma concentrations are attained at 1.5-2 hours after oral administration.
Slovenian: Največje plazemske koncentracije doseže 1,5 do 2 uri po peroralni uporabi.
English: It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Slovenian: Pričakovani učinek je blokada vseh učinkov angiotenzina II, ki se prenašajo prek receptorja AT1, ne glede na izvor ali sintezno pot angiotenzina II.
English: In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Ifirmasta (see section 4.5).
Slovenian: Pri dodatni uvedbi diuretika, kot je hidroklorotiazid, se je pokazal sinergistični učinek z zdravilom Ifirmasta (gl. poglavje 4.5).
English: Furthermore, irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Slovenian: Poleg tega je irbesartan sprožil hiperplazijo/hipertrofijo jukstaglomerulnih celic (pri podganah pri ≥ 90 mg/kg/dan, pri opicah makako pri ≥ 10 mg/kg/dan).
English: 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).
Slovenian: 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 izločanja za najmanj 30 % začetne vrednosti).
English: The usual dose is 150 mg once a day.
Slovenian: Običajni odmerek je 150 mg enkrat na dan.
English: The blood pressure lowering effect of irbesartan is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Slovenian: Učinek irbesartana na znižanje krvnega tlaka se pokaže po 1 do 2 tednih, največji učinek pa nastopi 4 do 6 tednov po začetku zdravljenja.
English: When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Slovenian: Pri podrobnem proučevanju posameznih podrobnosti glavnega opazovanega dogodka niso opazili učinka na celotno smrtnost, opazili pa so zmanjšanje pogostosti končne ledvične odpovedi in pomembno zmanjšanje podvojitve koncentracij serumskega kreatinina.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 56x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 56 filmsko obloženih tablet 56x1 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet
English: 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).
Slovenian: 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).
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo.
Slovenian: Pri IDNT je šlo za dvojno slepo kontrolirano preizkušanje vpliva irbesartana na obolevnost in smrtnost v primerjavi z amlodipinom in placebom.
English: In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Slovenian: Pediatrična populacija: 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 učinki: glavobol (7,9 %), hipotenzija (2,2 %), omotica (1,9 %), kašelj (0,9 %).
English: The following table presents the adverse medicinal product reactions that were reported in placebocontrolled trials in which 1,965 hypertensive patients received irbesartan.
Slovenian: V nadaljevanju so zbrani neželeni učinki zdravila, o katerih so poročali v s placebom kontroliranih preizkušanjih, v katerih je sodelovalo 1965 bolnikov z visokim krvnim tlakom, ki so jemali irbesartan.