FrancophonIA/ELRC3.0 huggingface dataset:
English: A small statistically significant increase in the PCE was observed in a pre-specified subgroup of patients with angina patients in CCS class II or higher at baseline (n = 12,049) (annual rates 3.4% versus 2.9%, relative risk ivabradine/placebo 1.18, p = 0.018), but not in the subgroup of the overall angina population in CCS class ≥ I (n = 14,286) (relative risk ivabradine/placebo 1.11, p = 0.110).
Slovenian: ali višjega razreda v izhodišču glede na oceno kanadskega srčno-žilnega združenja (CCS) (n = 12.049) (letna stopnja 3,4 % v primerjavi z 2,9%, relativno tveganje ivabradin : placebo 1,18, p = 0,018), vendar ne v podskupini skupne populacije bolnikov z angino pektoris iz razreda ≥ I (n = 14.286) (relativno tveganje ivabradin : placebo 1,11, p = 0,110) glede na oceno CCS.
English: Ivabradine influences retinal function.
Slovenian: Ivabradin vpliva na delovanje mrežnice.
English: Posology For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.
Slovenian: Odmerjanje Za različna odmerjanja so na voljo filmsko obložene tablete, ki vsebujejo 5 mg in 7,5 mg ivabradina.
English: A large dose of Ivabradine Zentiva could make you feel breathless or tired because your heart slows down too much.
Slovenian: Če ste vzeli večji odmerek zdravila Ivabradine Zentiva, kot bi smeli Velik odmerek zdravila Ivabradin Zentiva bi lahko povzročil zasoplost ali utrujenost, ker preveč upočasni srce.
English: Do not take Ivabradine Zentiva if you are breast-feeding (see “Do not take Ivabradine Zentiva”).
Slovenian: Ne jemljite zdravila Ivabradin Zentiva, če dojite (glejte “Ne jemljite zdravila Ivabradin Zentiva”).
English: In a 1,277-patients randomised placebo-controlled study, ivabradine demonstrated a statistically significant additional efficacy on response to treatment (defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill ETT) on top of amlodipine 5 mg o.d. or nifedipine GITS 30 mg o.d. at the trough of drug activity (12 hours after oral ivabradine intake) over a 6-week treatment period (OR = 1.3, 95% CI [1.0 - 1.7]; p = 0.012).
Slovenian: V randomizirani, s placebom nadzorovani študiji pri 1.277 bolnikih je ivabradin kot dodatek amlodipinu 5 mg enkrat na dan ali nifedipinu GITS (gastrointestinalni terapevtski sistem) 30 mg enkrat na dan v času najmanjšega učinka (12 ur po peroralnem jemanju) med 6-tedenskim zdravljenjem (razmerje obetov = 1,3; 95% interval zaupanja [1,0-1,7]; p = 0,012) dokazal statistično značilno dodatno učinkovitost pri odzivu na zdravljenje (definiranem kot zmanjšanje za najmanj 3 napade angine pektoris na teden in/ali podaljšanje časa do 1-mm depresije segmenta ST za najmanj 60 s med obremenitvenim testiranjem (ETT) hoje po tekočem traku).
English: In the subgroup of patients with HR ≥ 75 bpm (n = 4,150), a greater reduction was observed in the primary composite endpoint of 24% (hazard ratio: 0.76, 95% CI [0.68; 0.85], p < 0.0001) and for other secondary endpoints, including all cause death (hazard ratio: 0.83, 95% CI [0.72; 0.96], p = 0.0109) and CV death (hazard ratio: 0.83, 95% CI [0.71; 0.97], p = 0.0166).
Slovenian: V podskupini bolnikov s srčno frekvenco ≥ 75 utripov na minuto (n=4150) je bilo opazno večje zmanjšanje primarnega končnega izida za 24 % (razmerje tveganja: 0,76, 95 % interval zaupanja [0,68; 0,85] - p<0,0001) in drugih sekundarnih končnih izidov, vključno z umrljivostjo zaradi različnih vzrokov (razmerje tveganja: 0,83, 95 % interval zaupanja [0,72; 0,96] - p=0,0109) in srčno-žilno umrljivostjo (razmerje tveganja: 0,83, 95 % interval zaupanja [0,71; 0,97] - p=0,0166).
English: The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial conducted in 6,505 adult patients with stable chronic CHF (for ≥ 4 weeks), NYHA class II to IV, with a reduced left ventricular ejection fraction (LVEF ≤ 35%) and a resting heart rate ≥ 70 bpm.
Slovenian: Študija SHIFT je bila obsežno multicentrično, mednarodno, randomizirano, dvojno slepo, s placebo nadzorovano preskušanje izida, ki je zajelo 6505 odraslih bolnikov s stabilnim kroničnim srčnim popuščanjem (≥ 4 tedne) II.
English: - If you suffer from moderate liver problems.
Slovenian: - če imate zmerne težave z jetri.
English: The usual recommended starting dose is one tablet of Ivabradine Zentiva 5 mg twice daily increasing if necessary to one tablet of Ivabradine Zentiva 7.5 mg twice daily.
Slovenian: Če se zdravite zaradi kroničnega srčnega popuščanja Običajen priporočljiv začetni odmerek je ena tableta zdravila Ivabradin Zentiva 5 mg dvakrat na dan, kar lahko povečate na eno tableto zdravila Ivabradin Zentiva 7,5 mg dvakrat na dan, če je potrebno.
English: Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including betablocker therapy or when beta-blocker therapy is contraindicated or not tolerated (see section 5.1).
Slovenian: do IV. razreda po funkcijski razvrstitvi Newyorškega društva za srce (NYHA) s sistolično disfunkcijo pri bolnikih v sinusnem ritmu, pri katerih je srčna frekvenca ≥ 75 utripov na minuto, v kombinaciji s standardno terapijo, vključno z zdravljenjem z antagonistom adrenergičnih receptorjev beta oziroma tudi ko je zdravljenje z antagonistom adrenergičnih receptorjev beta kontraindicirano ali ga bolnik ne prenaša dobro (glejte poglavje 5.1).
English: In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95% CI [0.74; 1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56; 1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31; 1.53]).
Slovenian: V podskupini bolnikov s srčno frekvenco ≥ 75 utripov na minuto zdravljenih s priporočenim ciljnim odmerkom antagonista adrenergičnih receptorjev beta, ni bilo opažene statistično značilne koristi glede primarnega sestavljenega končnega izida (razmerje tveganja: 0,97, 95 % interval zaupanja [0,74; 1,28]) in drugih sekundarnih končnih izidov, vključno s hospitalizacijo zaradi poslabšanja srčnega popuščanja (razmerje tveganja: 0,79, 95 % interval zaupanja [0,56; 1,10]) ali umrljivosti zaradi srčnega popuščanja (razmerje tveganja: 0,69, 95 % [0,31; 1,53]).
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Ivabradine Zentiva.
Slovenian: Če dojite ali nameravate dojiti se posvetujte z zdravnikom, ker morate z dojenjem prekiniti, če jemljete zdravilo Ivabradin Zentiva.
English: Specific drug-drug interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG-CoA reductase inhibitors (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin.
Slovenian: Specifične študije o medsebojnih delovanjih z zdravili niso pokazale klinično signifikantnega učinka naslednjih zdravil na farmakokinetiko in farmakodinamiko ivabradina: zaviralcev protonske črpalke (omeprazola, lansoprazola), sildenafila, zaviralcev hidroksimetilglutaril koencim A (HMG CoA)
English: How to take Ivabradine Zentiva 4.
Slovenian: Kako jemati zdravilo Ivabradin Zentiva 4.
English: The intake of St. John's Wort should be restricted during the treatment with ivabradine.
Slovenian: Uživanje šentjanževke morate med zdravljenjem z ivabradinom omejiti.
English: - If you suffer from severe renal problems.
Slovenian: - če imate hude težave z ledvicami.
English: Ivabradine Zentiva 5 mg film-coated tablets are oblong, one side and both edges scored white tablets with dimensions 4.8×8.8 mm.
Slovenian: Izgled zdravila Ivabradin Zentiva in vsebina pakiranja Ivabradin Zentiva 5 filmsko obložene tablete so podolgovate, z zarezo na eni strani in obeh robovih, bele tablete velikosti 4,8×8,8 mm. Tableta se lahko deli na enake odmerke.
English: Primary composite endpoint Components of the composite: - CV death - Hospitalisation for worsening HF Other secondary endpoints - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Slovenian: - smrt zaradi različnih vzrokov - smrt zaradi odpovedi srca - hospitalizacija zaradi kateregakoli vzroka
English: - QT prolonging medicines to treat either heart rhythm disorders or other conditions:
Slovenian: - zdravila proti motnjam srčnega ritma ali drugim stanjem, ki podaljšujejo interval QT:
English: Common (may affect up to 1 in 10 people) - Modification in the heart functioning (the symptoms are a slowing down of the heart rate).
Slovenian: - Spremembe načina dela srca (simptom je znižana srčna frekvenca).
English: As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Slovenian: Če ste prenehali jemati zdravilo Ivabradin Zentiva Ker je zdravljenje angine pektoris ali kroničnega srčnega popuščanja običajno doživljenjsko, se pred prenehanjem jemanja tega zdravila posvetujte z zdravnikom.
English: Ivabradine Zentiva 7.5 mg film-coated tablets: White to off white, round tablet with diameter 7.1 mm.
Slovenian: Ivabradin Zentiva 7,5 mg filmsko obložene tablete: Bele do umazano bele, okrogle tablete premera 7,1 mm.
English: How to store Ivabradine Zentiva 6.
Slovenian: Shranjevanje zdravila Ivabradin Zentiva 6.
English: Ventricular extrasystoles Atrial fibrillation Uncommon Palpitations Supraventricular extrasystoles
Slovenian: Srčne bolezni pogosti bradikardija atrioventrikularni blok 1. stopnje (podaljšan interval PQ elektrokardiograma) ventrikularne ekstrasistole atrijska fibrilacija občasni palpitacije, supraventrikularne ekstrasistole zelo redki
English: Ivabradine Zentiva 7.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ivabradin Zentiva 7,5 mg
English: Ivabradine is not recommended in patients with AV-block of 2
Slovenian: Uporaba pri bolnikih z atrioventrikularnim blokom 2. stopnje Ivabradin ni priporočljiv pri bolnikih z atrioventrikularnim blokom 2. stopnje.
English: Ivabradine Zentiva 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ivabradin Zentiva 5 mg
English: The concomitant use of ivabradine with these medicinal products is contraindicated (see section
Slovenian: Sočasno jemanje ivabradina s tovrstnimi zdravili je kontraindicirano (glejte poglavje 4.3).
English: They particularly occur within the first 2 to 3 months of treatment initiation.
Slovenian: Pojavljajo se predvsem v prvih 2
English: Each film-coated tablet contains 5 mg ivabradine (as hydrochloride) or 7.5 mg ivabradine (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg ivabradina (v obliki klorida) ali 7,5 mg ivabradina (v obliki klorida).
English: How does Ivabradine Zentiva work?
Slovenian: Kako deluje zdravilo Ivabradine Zentiva?
English: - The other ingredients are in the tablet core: Mannitol, crospovidone, magnesium stearate, and in the film-coating: hypromellose, titanium dioxide, macrogol 400, glycerol.
Slovenian: - Pomožne snovi v jedru tablete so: manitol, krospovidon, magnezijev stearat, in v filmski oblogi:
English: - CYP3A4 inducers: CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St. John's Wort]) may decrease ivabradine exposure and activity.
Slovenian: barbiturati, fenitoin, Hypericum perforatum [šentjanževka]) lahko zmanjšujejo izpostavljenost ivabradinu in njegovo aktivnost.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA peroralna uporaba
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja občasni *
English: One film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg ivabradina (v obliki klorida).
English: - AV-block of 3
Slovenian: - atrioventrikularni blok 3. stopnje.
English: Avoid grapefruit juice during treatment with Ivabradine Zentiva.
Slovenian: Zdravilo Ivabradin Zentiva skupaj s hrano in pijačo Med zdravljenjem z zdravilom Ivabradin Zentiva se izogibajte uživanju grenivkinega soka.
English: How to take Ivabradine Zentiva
Slovenian: Kako jemati zdravilo Ivabradin Zentiva
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation: - In clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals.
Slovenian: Ivabradin ne vpliva na znotrajsrčno prevajanje, kontraktilnost (ni negativnega inotropnega učinka) ali repolarizacijo prekatov:
English: Ivabradine Zentiva 7.5 mg film-coated tablets:
Slovenian: Ivabradin Zentiva 7,5 mg filmsko obložene tablete:
English: Ivabradine is approximately 70% plasma protein bound and the volume of distribution at steady-state is close to 100 L in patients.
Slovenian: Ivabradin se veže na beljakovine v plazmi v približno 70 % in volumen porazdelitve v stanju dinamičnega ravnovesja pri bolnikih znaša blizu 100 l. Največja koncentracija v plazmi po kroničnem jemanju priporočenega odmerka 5 mg dvakrat na dan je 22 ng/ml (koeficient variacije = 29 %).
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI*
English: Ivabradine Zentiva 5 mg film-coated tablets Ivabradine
Slovenian: Ivabradin Zentiva 5 mg filmsko obložene tablete ivabradin
English: Ivabradine Zentiva 5 mg film-coated tablets Ivabradine Zentiva 7.5 mg film-coated tablets
Slovenian: Ivabradin Zentiva 5 mg filmsko obložene tablete Ivabradin Zentiva 7,5 mg filmsko obložene tablete
English: Other side effects have also been reported:
Slovenian: Komponente sestavljenega končnega izida:
English: - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2).
Slovenian: (ketokonazol,itrakonazol), makrolidni antibiotiki (klaritromicin, eritromicin peroralno, josamicin,telitromicin), zaviralci proteaze virusa HIV (nelfinavir, ritonavir) in nefazodon (glejte poglavji 4.5 in 5.2).
English: - Sick sinus syndrome.
Slovenian: - sindrom bolnega sinusnega vozla.
English: Headache, generally during the first month of treatment
Slovenian: Bolezni živčevja pogosti glavobol, večinoma v prvem mesecu zdravljenja omotica, možno zaradi bradikardije občasni *
English: One film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (v obliki klorida).
English: QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone).
Slovenian: - srčno-žilna zdravila, ki podaljšujejo interval QT (na primer kinidin, dizopiramid, bepridil, sotalol,
English: - If you are having a heart attack.
Slovenian: - če imate miokardni infarkt.
English: Treatment effect on the primary composite endpoint, its components and secondary endpoints
Slovenian: Učinek zdravljenja na primarni sestavljeni končni izid, njegove komponente in sekundarne končne izide ivabradin (N = 3241) n (%)
English: Ivabradine Zentiva 7.5 mg film-coated tablets Ivabradine
Slovenian: Ivabradin Zentiva 7,5 mg filmsko obložene tablete ivabradin
English: Ivabradine Zentiva 5 mg film-coated tablets:
Slovenian: Ivabradin Zentiva 5 filmsko obložene tablete:
English: itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir)
Slovenian: - če že jemljete zdravila proti glivičnim okužbam (na primer ketokonazol, itrakonazol), makrolidne antibiotike (na primer josamicin, klaritromicin, telitromicin ali eritromicin peroralno), zdravila proti okužbam z virusom HIV (na primer nelfinavir, ritonavir) ali nefazodon (zdravilo proti depresiji) ali diltiazem, verapamil (uporabljata se za zniževanje krvnega tlaka oz. zdravljenje angine pektoris).
English: Therefore, ivabradine is contra-indicated during pregnancy (see section 4.3).
Slovenian: Morebitno tveganje pri ljudeh ni znano, zato je ivabradin kontraindiciran med nosečnostjo (glejte poglavje 4.3).
English: What Ivabradine Zentiva is and what it is used for
Slovenian: Kaj je zdravilo Ivabradin Zentiva in za kaj ga uporabljamo Zdravilo Ivabradin Zentiva (ivabradin) je zdravilo za srce, namenjeno za zdravljenje:
English: The mean ivabradine doses allowing to achieve a 20% HRR were 0.13±0.04 mg/kg b.i.d., 0.10±0.04 mg/kg b.i.d.
Slovenian: Povprečni odmerki ivabradina, s katerimi so dosegli 20% znižanje srčne frekvence, so bili pri podskupini bolnikov, starih [1-3] leta, 0,13 ± 0,04 mg/kg dvakrat na dan, pri bolnikih, starih [3-18] let, ki so tehtali manj kot 40 kg, 0,10 ± 0,04 mg/kg dvakrat na dan ter pri bolnikih, starih [3-18] let, ki so tehtali 40 kg ali več, 4,1 ± 2,2 mg dvakrat na dan.
English: How to store Ivabradine Zentiva
Slovenian: Shranjevanje zdravila Ivabradin Zentiva
English: About chronic heart failure
Slovenian: O kroničnem srčnem popuščanju:
English: Erythema Pruritus Urticaria
Slovenian: Ledvična okvara
English: - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Slovenian: hidroklorotiazid, indapamid (ki se uporabljajo za zdravljenje edema, visokega krvnega tlaka).
English: - Severe hepatic insufficiency.
Slovenian: - hudo jetrno popuščanje.
English: Package leaflet: Information for the patient Ivabradine Zentiva 5 mg film-coated tablets Ivabradine Zentiva 7.5 mg film-coated tablets
Slovenian: Navodilo za uporabo Ivabradin Zentiva 5 mg filmsko obložene tablete Ivabradin Zentiva 7,5 mg filmsko obložene tablete ivabradin
English: Uncommon Hyperuricaemia
Slovenian: Presnovne in prehranske motnje občasni hiperurikemija
English: Management
Slovenian: Češka
English: Special warnings
Slovenian: DRUGI PODATKI
English: Talk to your doctor or pharmacist before taking Ivabradine Zentiva - If you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called “long QT syndrome”.
Slovenian: vztrajno atrijsko fibrilacijo (vrsto nerednega srčnega utripa) ali nepravilnost v elektrokardiogramu (EKG), ki se imenuje 'podaljšan interval QT.
English: nd and 3
Slovenian: PRILOGA III
English: INFORMATION IN BRAILLE
Slovenian: KLINIČNI PODATKI
English: Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers or - in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
Slovenian: - v kombinaciji z antagonisti adrenergičnih receptorjev beta pri bolnikih, ki ob optimalnem odmerku antagonistov adrenergičnih receptorjev beta nimajo urejene bolezni.
English: Frequency Preferred Term
Slovenian: Primarni sestavljeni končni izid
English: Uncommon Nausea Constipation Diarrhoea
Slovenian: Ušesne bolezni, vključno z motnjami labirinta občasni vrtoglavica
English: Ivabradine Zentiva 7.5 mg film-coated tablets are white to off white, round tablet with diameter 7.1 mm. Ivabradine Zentiva is packed in OPA/Alu/PVC-Alu blisters and in paper carton.
Slovenian: Ivabradin Zentiva 7,5 mg filmsko obložene tablete so bele do umazano bele, okrogle tablete premera 7,1 mm.
English: Ivabradine
Slovenian: Ivabradin je indiciran:
English: • The Committee considered the notification of the referral triggered by the United Kingdom under article 29(4) of Directive 2001/83/EC.
Slovenian: • odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožilo Združeno kraljestvo skladno s členom 29(4) Direktive 2001/83/ES.
English: However, the number of responders increased to 33 (92%) after both stimulants were tried.
Slovenian: Vendar pa se je število otrok, ki so se odzvali, povišalo na 33 (92 %), potem ko so preskusili oba stimulanta.
English: The reason for the different responses could be different pharmacological mechanisms of action.
Slovenian: Vzrok za različne odzive bi lahko bili različni farmakološki mehanizmi delovanja.
English: In addition, this was an independent study published in 1991 which precludes the assessment of the original data.
Slovenian: Poleg tega gre za neodvisno študijo, objavljeno leta 1991, kar onemogoča oceno originalnih podatkov.
English: Risk for abuse and dependence
Slovenian: Tveganje za zlorabo in odvisnost
English: Overall summary of the scientific evaluation of Dexamed (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Dexamed (glejte Prilogo I)
English: At the final CMDh discussion, there were two major issues where agreement could not be reached by Member States.
Slovenian: Na zadnji razpravi skupine CMDh sta ostali odprti dve pomembnejši vprašanji, v zvezi s katerima države članice niso mogle doseči soglasja.
English: However it is noted that overall very few data is available in clinical practice to support this.
Slovenian: Vendar je treba izpostaviti, da je na splošno v klinični praksi na voljo zelo malo podatkov, s katerimi bi to lahko potrdili.
English: Risks associated with long term use
Slovenian: Tveganja, povezana z dolgotrajno uporabo
English: The Netherlands considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Slovenian: Nizozemska je menila, da bi lahko odobritev dovoljenja za promet pomenila resno tveganje za javno zdravje;
English: The number of patients was small and the statistical significance of the findings is uncertain.
Slovenian: Bolnikov je bilo malo, zato je statistična značilnost ugotovitev negotova.
English: In the Elia et al. study, approximately 30% of participants did not respond to one treatment but only 4% were non-responders to both.
Slovenian: V študiji, ki so jo izvedli Elia in sodelavci, se na eno vrsto zdravljenja ni odzvalo približno 30 % udeležencev, samo 4 % pa se niso odzvali na obe.
English: All of these measures, taken together with existing national laws concerning manufacture, distribution and prescription of controlled drugs are considered to balance the risk.
Slovenian: Vsi ti ukrepi skupaj z obstoječimi nacionalnimi zakonodajami glede izdelave, distribucije in predpisovanja nadzorovanih drog odtehtajo tveganje.
English: There are, however, methodological problems with this study.
Slovenian: Vendar pa so bile pri tej študiji ugotovljene metodološke pomanjkljivosti.
English: The CHMP was therefore asked to consider:
Slovenian: Odbor CHMP je bil zato zaprošen, da prouči naslednje:
English: During the assessment of the application at Member State level, advice from the PRAC on the risk management plan was sought and the applicant agreed with the recommendation to:
Slovenian: Med ocenjevanjem vloge na ravni držav članic je bil odbor PRAC zaprošen za nasvet glede načrta za obvladovanje tveganja, nato pa se je predlagatelj strinjal z naslednjim priporočilom:
English: While the review has methodological limitations, the conclusions reached are based on relevant evidence.
Slovenian: Čeprav je imel pregled metodološke omejitve, končni zaključki temeljijo na ustreznih dokazih.
English: It is a Central Nervous System stimulant, more potent than the racemic mixture.
Slovenian: Je stimulant centralnega živčnega sistema, ki je močnejši od racemne zmesi.
English: These data are further supported by the Arnold et al. (1978) study.
Slovenian: Te podatke je dodatno potrdila študija, ki so jo opravili Arnold in sodelavci (1978).
English: There is also evidence that amfetamines increase release and turnover of serotonin.
Slovenian: Prav tako obstajajo dokazi, da amfetamini povečajo sproščanje in pretvorbo serotonina.