FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL WARNINGS
Slovenian: POSEBNA OPOZORILA
English: Wearing disposable gloves, apply the cream gently to the lesion.
Slovenian: Nadenite si rokavice za enkratno uporabo in kremo nežno nanesite na prizadeto mesto.
English: Clean the affected areas and clip the hair covering the lesions before application.
Slovenian: Pred uporabo prizadete predele očistite in odstrizite dlako.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Resocortol butyrate 1mg/g
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Resokortol butirat, 1 mg/g
English: Once broached, use within 8 weeks
Slovenian: Načeto/odprto zdravilo uporabite v 8 tednih.
English: STATEMENT OF THE ACTIVE SUBSTANCE Resocortol butyrate: 1mg/g
Slovenian: NAVEDBA UČINKOVINE Resokortol butirat: 1 mg/g
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: QUANTITY OF THE ACTIVE SUBSTANCE Resocortol butyrate 1 mg/g
Slovenian: KOLIČINA ZDRAVILNE UČINKOVINE Resokortol butirat, 1 mg/g
English: During initial treatment apply the cream twice daily.
Slovenian: Na začetku zdravljenja nanašajte kremo dvakrat na dan. Zdravite 7 do 14 dni.
English: Wear disposable gloves when applying the product.
Slovenian: Ko izdelek nanašate, nosite rokavice za enkratno uporabo.
English: Do not use in dogs used for breeding and in lactating or pregnant bitches.
Slovenian: Ne uporabite pri psih, ki so namenjeni vzreji, in pri doječih ali brejih psicah.
English: Pruban contains the active principle resocortol butyrate.
Slovenian: Pruban vsebuje zdravilno učinkovino resokortol butirat.
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Slovenian: A. IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 15 g
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
English: Treatment of acute localised moist dermatitis.
Slovenian: Zdravljenje akutnega, lokaliziranega vlažnega dermatitisa
English: INDICATION Treatment of acute localised moist dermatitis.
Slovenian: INDIKACIJA Zdravljenje akutnega, lokaliziranega vlažnega dermatitisa.
English: Veterinary medicinal product subject to prescription.
Slovenian: Izdaja zdravila za uporabo v veterinarski medicini je le na recept.
English: Not applicable
Slovenian: NEŽELENI UČINKI
English: B. PACKAGE INSERT
Slovenian: B. NAVODILO ZA UPORABO
English: 6.3 Special precautions for storage
Slovenian: 4.5 Posebni previdnostni ukrepi
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance(s)
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna(e) učinkovina(e) Resokortol butirat
English: INDICATION(S) Treatment of acute localised moist dermatitis.
Slovenian: INDIKACIJE Zdravljenje akutnega, lokaliziranega vlažnega dermatitisa.
English: Apply to the affected skin by gently applying it to the lesion.
Slovenian: Nežno nanesite na prizadeti predel kože.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN" Keep out of reach and sight of children
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
English: STATEMENT OF THE MRLs
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
English: ROUTE(S) OF ADMINISTRATION Cutaneous use.
Slovenian: NAČIN(I) UPORABE ZDRAVILA Dajanje na kožo in kožne tvorbe.
English: 30 June 2024
Slovenian: 30. junij 2024
English: Submission of study results:
Slovenian: Predložitev rezultatov študije:
English: A risk to the suckling child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ne moremo izključiti.
English: pH: 5.0 to 6.0
Slovenian: pH: od 5,0 do 6,0.
English: You will only be given this medicine if the possible benefit is greater than the possible risks.
Slovenian: To zdravilo boste prejeli le, če je morebitna korist večja od morebitnih tveganj.
English: It has not been tested in other types of shock.
Slovenian: Niso ga preskušali pri nobeni drugi vrsti šoka.
English: If this occurs, hospital staff will monitor your vital signs and you will be provided with supportive care.
Slovenian: Če pride do tega, bo bolnišnično osebje spremljalo vaše vitalne znake in vam nudilo podporno oskrbo.
English: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath Ireland
Slovenian: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath Irska
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba zdravilo uporabiti takoj.
English: Final concentration (ng/mL)
Slovenian: Končna koncentracija (ng/ml)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve:
English: One patient in each arm discontinued treatment as a result.
Slovenian: Po en bolnik iz vsake skupine je zaradi tega prekinil zdravljenje.
English: 38/58 patients mITT=modified intent-to-treat population
Slovenian: 38/58 bolnikov mITT = modificirana populacija z namenom zdravljenja
English: Median age was 64 years (range: 22-89 years).
Slovenian: Mediana starost je bila 64 let (razpon: 22-89 let).
English: 4.7 Effects on ability to drive and use machines Not relevant.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Podatek ni potreben.
English: Use of this medicine during pregnancy should be avoided if possible.
Slovenian: Če je le mogoče, se je treba uporabi tega zdravila med nosečnostjo izogibati.
English: These types of symptoms occur in greater than 1 out of every 10 patients.
Slovenian: Tovrstni simptomi se pojavijo pri več kot 1 od
English: The dose depends on your body weight.
Slovenian: Odmerek je odvisen od vaše telesne mase.
English: Mechanism of action and pharmacodynamic effects
Slovenian: Mehanizem delovanja in farmakodinamični učinki
English: The effect on MAP was sustained for at least the first three hours of treatment.
Slovenian: Učinek na MAP se je ohranil vsaj prve tri ure zdravljenja.
English: 91% of subjects had septic shock; the remaining subjects had other forms of distributive shock such as neurogenic shock.
Slovenian: 91 % preiskovancev je imelo septični šok; preostali preiskovanci so imeli druge oblike distribucijskega šoka, kot je nevrogeni šok.
English: Fluid Restricted?
Slovenian: Omejen vnos tekočin?
English: Your doctor may already be giving you other medicines used to increase your blood pressure.
Slovenian: Zdravnik vam morda že daje druga zdravila, ki se uporabljajo za zviševanje krvnega tlaka.
English: Osmolarity: 130 to 170 mOsm/kg
Slovenian: Osmolarnost: od 130 do 170 mOsm/kg.
English: Storage conditions
Slovenian: Pogoji shranjevanja
English: The effect on blood pressure is sustained for at least the first three hours of continuous intravenous infusion.
Slovenian: Učinek na krvni tlak se ohrani vsaj prve tri ure neprekinjene intravenske infuzije.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake „EXP“.
English: The effect of GIAPREZA on morbidity and mortality has not been determined in appropriate studies.
Slovenian: Učinka zdravila GIAPREZA na obolevnost in smrtnost niso ugotavljali v ustreznih študijah.
English: Your doctor will continue to assess your response and will adjust the dose accordingly up to a maximum of 80 ng per kilogram each minute during the first 3 hours of treatment.
Slovenian: Zdravnik bo še naprej ocenjeval vaš odziv in bo skladno z njim prilagodil odmerek do največ 80 ng na kilogram na minuto v prvih treh urah zdravljenja.
English: Primary efficacy endpoints: MAP response at hour 3 (mITT population and subgroups)
Slovenian: Preglednica 3: Primarni opazovani dogodki učinkovitosti: Odziv MAP po 3 urah (populacija mITT in podskupine)
English: For critically ill patients, the usual target mean arterial pressure is 65 - 75 mmHg.
Slovenian: Pri kritično bolnih bolnikih je običajni ciljni povprečni arterijski tlak 65-75 mmHg.
English: In the ATHOS-3 trial, the median time to increase blood pressure was approximately 5 minutes.
Slovenian: V preskušanju ATHOS-3 je bil mediani čas do zvišanja krvnega tlaka približno 5 minut.
English: Your doctor should be told if you are using, have recently used, or might use any other medicines.
Slovenian: Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Store in a refrigerator (2-8 °C).
Slovenian: Shranjujte v hladilniku (2-8 °C).
English: The median duration of treatment in clinical trials was 48 hours (range: 3.5 to 168 hours).
Slovenian: Mediano trajanje zdravljenja v kliničnih preskušanjih je bilo 48 ur (razpon: od 3,5 do 168 ur).
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: This leaflet was last revised in MM/YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL.
English: You will be monitored closely to make sure that your blood pressure is at the right level.
Slovenian: Skrbno vas bodo spremljali in se prepričali, da je vaš krvni tlak na pravi ravni.
English: The diluted solution should be used immediately.
Slovenian: Razredčeno raztopino je treba uporabiti takoj.
English: What you need to know before you are given GIAPREZA 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo GIAPREZA 3.
English: However, if you have side effects or think you have been given too much GIAPREZA, tell your doctor or nurse straight away.
Slovenian: Če pa imate neželene učinke ali menite, da ste prejeli prevelik odmerek zdravila GIAPREZA, takoj obvestite zdravnika ali medicinsko sestro.
English: There are no data available on the potential effects on fertility in humans.
Slovenian: Podatkov o možnih učinkih na plodnost pri ljudeh ni.
English: GIAPREZA should not be used in children or adolescents under 18 years of age as it has not been studied in these age groups.
Slovenian: Otroci in mladostniki Zdravila GIAPREZA se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker ga v teh starostnih skupinah niso preučevali.
English: Patients with cardiogenic shock were excluded (see section 4.4).
Slovenian: Bolniki s kardiogenim šokom so bili izključeni (glejte poglavje 4.4).
English: 114/163 patients
Slovenian: 114/163 bolnikov
English: Overdose may result in severe hypertension.
Slovenian: Zaradi prevelikega odmerjanja lahko pride do hude hipertenzije.
English: No treatment related adverse effects were observed.
Slovenian: Neželenih učinkov, povezanih z zdravljenjem, niso opazili.
English: What you need to know before you are given GIAPREZA You must not be given GIAPREZA: - if you are allergic to angiotensin II or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo GIAPREZA Zdravila GIAPREZA ne smete prejeti: - če ste alergični na angiotenzin II ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: BATCH NUMBER Lot:
Slovenian: ŠTEVILKA SERIJE Lot:
English: Of these, 7 cases corresponded to deep vein thrombosis.
Slovenian: Med njimi je bilo 7 primerov globoke venske tromboze.
English: GIAPREZA was tested in a small amount of patients more than 75 years of age.
Slovenian: Zdravilo GIAPREZA so preskušali pri manjšem številu bolnikov, starejših od 75 let.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1384/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/19/1384/001
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 - 8 °C or 25 °C.
Slovenian: Če zdravila ne uporabite takoj, je za čas shranjevanja med uporabo in pogoje pred uporabo odgovoren uporabnik; ta čas ne sme biti daljši od 24 ur pri temperaturi 2-8 ºC ali 25 °C.
English: Peripheral ischaemia
Slovenian: Periferna ishemija
English: GIAPREZA is used in an emergency setting to increase blood pressure to normal levels in adult patients with seriously low blood pressure who do not respond to fluids or other medicines that raise blood pressure.
Slovenian: Zdravilo GIAPREZA se uporablja v nujnih primerih za zviševanje krvnega tlaka na normalno raven pri odraslih bolnikih z resno znižanim krvnim tlakom, ki se ne odzivajo na tekočine ali druga zdravila za zviševanje krvnega tlaka.
English: While not all of these symptoms lead to life-threatening complications, your doctor should be told about them immediately.
Slovenian: Vsi ti simptomi sicer ne privedejo do smrtno nevarnih zapletov, kljub temu pa morate o njih takoj obvestiti zdravnika.
English: Of the 114 responders at Hour 3, only 2 (1.8%) received more than 80 ng/kg/min.
Slovenian: Od 114 odzivnih bolnikov po treh urah sta le dva (1,8 %) prejela več kot 80 ng/kg/min.
English: It is first diluted and then given as a drip (infusion) into a vein, supplying a specified dose each minute.
Slovenian: Najprej ga bodo razredčili in ga nato dali v obliki kapalne infuzije (infundiranja) v veno, s čimer boste vsako minuto prejeli določen odmerek.
English: The maximum dose after the first 3 hours will be 40 ng per kilogram each minute.
Slovenian: Največji odmerek po prvih treh urah je 40 ng na kilogram na minuto.
English: Yes
Slovenian: Da
English: It is metabolised by end terminal cleavage (at both the amino and carboxy termini) in a variety of tissues including erythrocytes, plasma and many of the major organs (ie, intestine, kidney, liver and lung).
Slovenian: Presnavlja se s terminalno cepitvijo (na amino in karboksi koncu) v različnih tkivih, vključno z eritrociti, plazmo in številnimi glavnimi organi (tj. črevesjem, ledvicami, jetri in pljuči).
English: The adverse reactions described in this section were identified in the pivotal clinical study (N = 163 treated with GIAPREZA).
Slovenian: Neželene učinke, opisane v tem poglavju, so zabeležili v ključni klinični študiji (N = 163 bolnikov, zdravljenih z zdravilom GIAPREZA).
English: As a part of your treatment, you may be given medicine to prevent the formation of blood clots.
Slovenian: sklopu zdravljenja boste morda prejeli zdravilo za preprečevanje nastajanja krvnih strdkov.
English: Peripheral ischaemia may be a consequence of the mechanism of action of GIAPREZA.
Slovenian: Periferna ishemija je lahko posledica mehanizma delovanja zdravila GIAPREZA.
English: Of the 321 patients treated in the Phase 3 study, 195 patients were male (60.7%), 257 (80%) patients were White, 33 (10%) were Black, and 31 (10%) were Other.
Slovenian: Od 321 bolnikov, zdravljenih v študiji 3. faze, je bilo 195 (60,7 %) moških, 257 (80 %) belcev, 33 (10 %) temnopoltih in 31 (10 %) druge rase.
English: Your doctor or nurse should be told if any of the above applies to you before this medicine is used.
Slovenian: Zdravniku ali medicinski sestri morate pred uporabo zdravila povedati, če kar koli od zgoraj navedenega velja za vas.
English: Mortality through day 28 was 46% on GIAPREZA and 54% on placebo (hazard ratio 0.78; 95% confidence interval 0.57-1.07).
Slovenian: Smrtnost do 28. dneva je bila 46 % pri zdravilu GIAPREZA in 54 % pri placebu (razmerje ogroženosti 0,78; 95-odstotni interval zaupanja 0,57-1.07).
English: Common side effects (may affect up to 1 in 10 people) are: - Rapid heartbeat - Poor circulation to your hands, feet, or other bodily areas which can be severe and cause tissue damage.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) so: - hiter srčni utrip, - slaba prekrvavitev v dlaneh, stopalih ali drugih delih telesa, ki je lahko huda in povzroči poškodbe tkiv.
English: No
Slovenian: Ne
English: Diluted solution should be clear and colourless.
Slovenian: Razredčena raztopina mora biti bistra in brezbarvna.
English: The clinical experience with GIAPREZA is limited to septic or other distributive shock.
Slovenian: Klinične izkušnje z zdravilom GIAPREZA so omejene na septični ali drugačen distribucijski šok.
English: The use of GIAPREZA is not recommended in other types of shock (e.g.: cardiogenic shock, etc) as patients with non-distributive shocks were excluded from clinical trials (see section 5.1).
Slovenian: Uporaba zdravila GIAPREZA ni priporočljiva pri drugih vrstah šoka (npr. kardiogenem šoku ipd.), saj so bili bolniki z nedistribucijskimi šoki izključeni iz kliničnih preskušanj (glejte poglavje 5.1).
English: 1017CB Amsterdam, Netherlands
Slovenian: 1017CB Amsterdam, Nizozemska
English: Due to the short half-life of GIAPREZA (less than one minute), an abrupt withdrawal of angiotensin may lead to rebound hypotension (see section 4.4).
Slovenian: Zaradi kratke razpolovne dobe zdravila GIAPREZA (manj kot ena minuta) lahko nenadna odtegnitev angiotenzina povzroči povratno hipotenzijo (glejte poglavje 4.4).
English: The effect of GIAPREZA when added to maximum doses of other vasopressors is unknown.
Slovenian: Učinek zdravila GIAPREZA ob dodajanju največjim odmerkom drugih vazopresorjev ni znan.
English: GIAPREZA should be prescribed by a physician experienced in the treatment of shock and is intended for use in an acute and hospital setting.
Slovenian: Zdravilo GIAPREZA sme predpisovati samo zdravnik z izkušnjami z zdravljenjem šoka in je namenjeno uporabi v akutnih primerih in v bolnišnici.
English: Your doctor will monitor your blood pressure and adjust your dose as needed.
Slovenian: Zdravnik bo spremljal vaš krvni tlak in po potrebi prilagodil odmerek.
English: At the time of study drug administration, 97% of subjects were receiving norepinephrine, 67% vasopressin, 15% phenylephrine, 13% epinephrine, and 2% dopamine.
Slovenian: V času dajanja študijskega zdravila je 97 % preiskovancev prejemalo norepinefrin, 67 % vazopresin, 15 % fenilefrin, 13 % epinefrin in 2 % dopamin.
English: Diluted solution may be stored at room temperature or under refrigeration.
Slovenian: Razredčeno raztopino lahko shranjujete pri sobni temperaturi ali v hladilniku.
English: After the initial dose, your doctor will adjust the rate as often as every 5 minutes until you achieve your target blood pressure.
Slovenian: Po začetnem odmerku bo zdravnik morda prilagajal odmerek tudi na vsakih 5 minut, dokler ne boste dosegli ciljnega krvnega tlaka.
English: Maintenance doses should not exceed 40 ng/kg per minute.
Slovenian: Vzdrževalni odmerki ne smejo presegati 40 ng/kg na minuto.
English: Inspect each vial for particulate matter prior to dilution.
Slovenian: Pred redčenjem vsako vialo preglejte glede prisotnosti delcev.
English: OTHER La Jolla Pharmaceutical
Slovenian: DRUGI PODATKI La Jolla Pharmaceutical
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and 2-8 °C.
Slovenian: Kemična in fizikalna stabilnost med uporabo je bila dokazana za 24 ur pri sobni temperaturi in temperaturi 2-8 ºC.
English: 1017 CB, Amsterdam The Netherlands
Slovenian: 1017 CB, Amsterdam Nizozemska
English: The treatment effect was consistent in high risk subsets of patients with low baseline MAP or high APACHE II score, which were stratification variables (Table 3).
Slovenian: Učinek zdravljenja je bil skladen v podskupini bolnikov z visokim tveganjem, ki so imeli nizko izhodiščno vrednost MAP ali visok rezultat APACHE II, kar sta bili stratifikacijski spremenljivki (preglednica 3).
English: From Hour 3 to Hour 48, GIAPREZA or placebo were titrated to maintain MAP between 65 and 70 mmHg while reducing doses of other vasopressors.
Slovenian: Od 3. do 48. ure so zdravilo GIAPREZA ali placebo titrirali do vzdrževanja MAP med 65 in 70 mmHg, hkrati pa so zmanjšali odmerke drugih vazopresorjev.
English: Placebo response rate
Slovenian: Stopnja odziva pri placebu
English: 83% of subjects had received two or more vasopressors and 47% three or more vasopressors prior to study drug administration.
Slovenian: 83 % preiskovancev je pred jemanjem študijskega zdravila prejemalo dva ali več vazopresorjev, 47 % pa tri ali več vazopresorjev.
English: If you notice any of these symptoms, seek medical advice immediately.
Slovenian: Če se pojavi kateri izmed navedenih simptomov, takoj poiščite zdravniško pomoč.
English: What GIAPREZA is and what it is used for 2.
Slovenian: Kaj je zdravilo GIAPREZA in za kaj ga uporabljamo 2.
English: Concentrate for solution for infusion 1 vial
Slovenian: koncentrat za raztopino za infundiranje 1 viala
English: GIAPREZA contains the active substance angiotensin II, a compound normally produced by the body.
Slovenian: Zdravilo GIAPREZA vsebuje učinkovino angiotenzin II, spojino, ki jo telo normalno proizvaja.
English: Your doctor or nurse should be told before GIAPREZA is used if you or someone else in your family have a history of blood clots, as this medicine has been associated with the formation of blood clots.
Slovenian: Pred uporabo zdravila GIAPREZA morate povedati zdravniku ali medicinski sestri, če ste imeli vi ali kdo drug v vaši družini kdaj krvne strdke, saj je to zdravilo povezano z nastankom krvnih strdkov.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with GIAPREZA in one or more subsets of the paediatric population for the treatment of hypotension in children who remain hypotensive despite fluid and vasopressor therapy.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom GIAPREZA za eno ali več podskupin pediatrične populacije pri zdravljenju hipotenzije pri otrocih, ki kljub tekočinskemu in vazopresorskemu zdravljenju ostajajo hipotenzivni.
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/10,000 to < 1/100), rare (≥ 1/10,000
Slovenian: Razredi pogostnosti so opredeljeni kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10),
English: Angiotensin II raises blood pressure by vasoconstriction; increased aldosterone release via direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells which stimulates Ca2+/calmodulin dependent phosphorylation of myosin and causes smooth muscle contraction.
Slovenian: Angiotenzin II zviša krvni tlak z vazokonstrikcijo; vezava na z G-proteinom sklopljeni receptor za angiotenzin II tipa 1 na gladkih mišičnih celicah žil posreduje povečano sproščanje aldosterona prek neposrednega delovanja angiotenzina II na žilno steno, kar stimulira od kalcijevih ionov (Ca2+) in kalmodulina odvisno fosforilacijo miozina in povzroči krčenje gladkih mišic.
English: Instructions for preparation of the medicinal product before administration 1.
Slovenian: Navodila za pripravo zdravila pred dajanjem
English: Tell your doctor or nurse immediately if you experience a change of colour (redness or paleness), pain, numbness in any of your limbs, or if any of your limbs are cold to the touch, as these could be signs that a blood clot has blocked blood flow to a part of the body.
Slovenian: Takoj obvestite zdravnika ali medicinsko sestro, če se vam spremeni barva kože (pordelost ali bledica), občutite bolečino, odrevenelost okončin ali če katera od okončin postane hladna na dotik, saj so to lahko znaki, da krvni strdek ovira pretok krvi v določen del telesa.
English: The major imbalance compared to placebo was in venous thromboembolism (6.1% vs 0%) (see section 4.8).
Slovenian: Največje neravnovesje v primerjavi s placebom je bilo zabeleženo pri venskih trombembolijah (6,1 % v primerjavi z 0 %) (glejte poglavje 4.8).