FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy in adult patients with PAH (when used in combination with epoprostenol) A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol.
Slovenian: Učinkovitost pri odraslih bolnikih s PAH (uporabljen v kombinaciji z epoprostenolom) Randomizirana, dvojno slepa, s placebom nadzorovana študija je bila narejena pri 267 bolnikih s PAH, stabiliziranih na intravenskem epoprostenolu.
English: In the two-placebo controlled studies adverse events were generally mild to moderate in severity.
Slovenian: V teh dveh s placebom nadzorovanih študijah so bili neželeni učinki na splošno blagi do zmerni.
English: The overall frequency of discontinuation in sildenafil treated patients at doses of 20 mg, 40 mg and 80 mg TID was 2.9 %, 3.0 % and 8.5 % respectively, compared to 2.9 % with placebo.
Slovenian: Skupna pogostnost prekinitev je bila pri bolnikih, ki so prejemali sildenafil v odmerku 20 mg trikrat na dan 2,9 %, 40 mg trikrat na dan 3,0 % in 80 mg trikrat na dan 8,5 %, v primerjavi s placebom, kjer je znašala 2,9 %.
English: *These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti pireksija * O teh neželenih učinkih/reakcijah so poročali pri bolnikih, ki so sildenafil jemali za zdravljenje moške erektilne disfunkcije (MED).
English: Most patients were WHO Functional Class II (107/277, 39 %) or III (160/277, 58 %) with a mean baseline 6 minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4 %) or IV (9/277, 3 %) at baseline.
Slovenian: Večina bolnikov je bila izhodiščno v funkcijskem razredu II (107/277, 39 %) ali III (160/277, 58 %) po razvrstitvi SZO, s povprečno doseženo razdaljo 378 metrov oz. 326 metrov na 6-minutnem testu hoje ob začetku študije; manj bolnikov je bilo ob začetku študije v razredu I (1/277, 0,4 %) ali IV (9/277, 3 %).
English: Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the oral bioavailability of sildenafil.
Slovenian: Posamični odmerki antacida (magnezijev hidroksid/aluminijev hidroksid) niso vplivali na peroralno biološko uporabnost sildenafila.
English: Revatio 10 mg/ml powder for oral suspension Sildenafil
Slovenian: Revatio 10 mg/ml prašek za peroralno suspenzijo sildenafil
English: figure 5
Slovenian: slika 5
English: Do not use this medicine after the expiry date which is stated on the bottle after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici poleg oznake »Uporabno do:«.
English: What Revatio is and what it is used for What you need to know before you take Revatio How to take Revatio
Slovenian: Kaj je zdravilo Revatio in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Revatio Kako jemati zdravilo Revatio Možni neželeni učinki
English: Study A1481262 was a single centre, single dose, open label study to assess the safety, tolerability and pharmacokinetics of a single intravenous dose of sildenafil (10 mg) administered as a bolus injection to patients with PAH who were already receiving and stable on oral Revatio 20 mg TID.
Slovenian: Študija A1481262 je bila monocentrična odprta študija z enim odmerkom za oceno varnosti, prenašanja in farmakokinetike enkratnega intravenskega odmerka sildenafila (10 mg) v bolusni injekciji pri bolnikih s PAH, ki so že dobivali peroralno zdravilo Revatio 20 mg trikrat na dan in so bili pri tem stabilni.
English: If you stop taking Revatio
Slovenian: Če ste prenehali jemati zdravilo Revatio
English: figure 2
Slovenian: slika 2
English: SLOWLY push down the plunger of the oral dosing syringe.
Slovenian: POČASI potisnite bat peroralne odmerne brizge.
English: Subjects were allocated to one of three sildenafil treatment groups, low (10 mg), medium (10-40 mg) or high dose (20-80 mg) regimens of Revatio given three times a day, or placebo.
Slovenian: Preiskovanci, zdravljeni s sildenafilom, so bili razporejeni v eno izmed treh skupin, režim zdravljenja z majhnimi odmerki (10 mg), srednjimi (10-40 mg) ali velikimi odmerki (20-80 mg) zdravila Revatio, ki so ga prejemali trikrat na dan, ali s placebom.
English: Revatio is used to treat adults with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Slovenian: Zdravilo Revatio uporabljamo za zdravljenje visokega krvnega tlaka v pljučnih žilah (pljučne arterijske hipertenzije) pri odraslih.
English: What Revatio looks like and contents of the pack Each pack of Revatio solution for injection contains one 20 ml clear glass vial, which is closed with a chlorobutyl rubber stopper and an aluminium seal.
Slovenian: Eno pakiranje zdravila Revatio raztopina za injiciranje vsebuje 20 ml prozorno stekleno vialo, zaprto s klorobutilnim gumijastim zamaškom in aluminijasto zaporko.
English: Revatio brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Slovenian: Zdravilo Revatio širi žile v pljučih in s tem zniža krvni tlak v pljučih.
English: Revatio 0.8 mg/ml solution for injection Sildenafil
Slovenian: Revatio 0,8 mg/ml raztopina za injiciranje sildenafil
English: Oral sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Slovenian: Peroralni sildenafil (50 mg) ni stopnjeval hipotenzivnih učinkov alkohola pri zdravih prostovoljcih, ki so imeli povprečno največjo koncentracijo alkohola v krvi 80 mg/dl.
English: Efficacy of intravenous sildenafil in adult patients with pulmonary arterial hypertension (PAH) A 10 mg dose of Revatio solution for injection is predicted to provide total exposure of free sildenafil and its N-desmethyl metabolite and their combined pharmacological effects comparable to those of a 20 mg oral dose.
Slovenian: Učinkovitost intravenskega sildenafila pri odraslih bolnikih s pljučno arterijsko hipertenzijo (PAH) Revatio raztopina za injiciranje v odmerku 10 mg predvidoma doseže takšno celotno izpostavljenost prostemu sildenafilu in njegovemu N-dezmetilnemu presnovku ter skupne farmakološke učinke, ki so primerljivi s peroralnim odmerkom 20 mg.
English: The Cmax and AUC (0-8) of the N-desmethyl metabolite were 30.8 ng/ml and 147 ng h/ml, respectively.
Slovenian: Vrednost Cmax N-dezmetilnega presnovka je bila 30,8 ng/ml, njegova AUC (0-8) pa 147 ng h/ml.
English: Wash the oral dosing syringe as instructed below.
Slovenian: Peroralno odmerno brizgo očistite po spodnjih navodilih.
English: Sildenafil (100 mg single dose) did not affect the steady state pharmacokinetics of the HIV protease inhibitor saquinavir, which is a CYP3A4 substrate/inhibitor.
Slovenian: Sildenafil (v posamičnem peroralnem odmerku 100 mg) ni vplival na farmakokinetiko zaviralca proteaze HIV sakvinavirja (ki je substrat/zaviralec CYP3A4) v stanju dinamičnega ravnovesja.
English: What Revatio is and what it is used for What you need to know before you are given Revatio How Revatio is given
Slovenian: Kaj je zdravilo Revatio in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Revatio Kako uporabljati zdravilo Revatio Možni neželeni učinki
English: At steady state plasma concentrations of N-desmethyl metabolite are approximately 16 % versus 61 % those of sildenafil after IV and oral dosing, respectively.
Slovenian: V stanju dinamičnega ravnovesja je koncentracija N-dezmetilnega presnovka po intravenski uporabi sildenafila približno 16 %, po peroralni pa 61 %.
English: When constituted the powder provides a white grape flavoured oral suspension.
Slovenian: Po rekonstituciji iz praška nastane bela peroralna suspenzija z okusom grozdja.
English: In a study of healthy volunteers oral sildenafil at steady state (80 mg three times a day) resulted in a 50 % increase in bosentan AUC (125 mg twice daily).
Slovenian: V študiji pri zdravih prostovoljcih je sildenafil v stanju dinamičnega ravnovesja (80 mg trikrat na dan) povzročil 50 % povečanje AUC bosentana (125 mg dvakrat na dan).
English: Revatio contains sorbitol
Slovenian: Zdravilo Revatio vsebuje sorbitol
English: The exposure to sildenafil in patients on CYP3A4 substrates and CYP3A4 substrates plus beta-blockers was 43 % and 66 % higher, respectively, compared to patients not receiving these classes of medicines.
Slovenian: V primerjavi z bolniki, ki niso dobivali substratov CYP3A4 oz. substratov CYP3A4 in antagonistov beta, je bila izpostavljenost sildenafilu pri prejemnikih substratov CYP3A4 večja za 43 %, pri prejemnikih substratov CYP3A4 in antagonistov beta pa za 66 %.
English: Sildenafil exposure was 5-fold higher at a dose of 80 mg three times a day compared to the exposure at a dose of 20 mg three times a day.
Slovenian: Izpostavljenost sildenafilu je bila ob odmerku 80 mg trikrat na dan 5krat večja kot ob odmerku 20 mg trikrat na dan.
English: (p=0.0017) and -320 dyne.sec/cm
Slovenian: 5 (p = 0,0017) in za 80 mg trikrat na dan -320 din.s/cm
English: figure 9
Slovenian: slika 9
English: In clinical trials side effects reported commonly (may affect up to 1 in 10 people) by patients with pulmonary arterial hypertension were facial flushing and nausea.
Slovenian: V kliničnih preskušanjih opisani pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) pri bolnikih s pljučno arterijsko hipertenzijo so zardevanje in občutek siljenja na bruhanje.
English: Side effects reported uncommonly (may affect up to 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.
Slovenian: Občasno opisani neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) so zmanjšana ostrina vida, dvojni vid, nenormalni občutki v očesu, krvavitev iz penisa, prisotnost krvi v spermi in/ali urinu ter povečanje prsi pri moških.
English: The study population consisted of 68 (25 %) men and 209 (75 %) women with a mean age of 49 years (range: 1881 years) and baseline 6-minute walk test distance between 100 and 450 metres inclusive (mean: 344 metres).
Slovenian: Povprečna starost je bila 49 let (razpon: od 18 do 81 let), dosežena razdalja na 6-minutnem testu hoje ob začetku študije pa od 100 do vključno 450 metrov (povprečje: 344 metrov).
English: A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy (62.5 mg - 125 mg twice a day) indicated an increase (20% (95% CI: 9.8 - 30.8)) of bosentan AUC with co-administration of steady-state sildenafil (20 mg three times a day) of a smaller magnitude than seen in healthy volunteers when co-administered with 80 mg sildenafil three times a day (see sections 4.4 and 5.1).
Slovenian: Populacijska farmakokinetična analiza podatkov iz študije pri odraslih bolnikih s PAH na osnovnem zdravljenju z bosentanom (62,5-125 mg dvakrat na dan) je pokazala povečanje (20 %; 95 % IZ: 9,8-30,8) AUC bosentana ob sočasni uporabi s sildenafilom v stanju dinamičnega ravnovesja (20 mg trikrat na dan).
English: Any remaining oral suspension should be discarded 30 days after constitution.
Slovenian: Preostalo peroralno suspenzijo zavrzite v 30 dneh po rekonstituciji.
English: What Revatio looks like and contents of the pack Revatio is supplied as a white to off-white powder for oral suspension providing a white, grape flavoured oral suspension when constituted with water.
Slovenian: Zdravilo Revatio je bel do skoraj bel prašek za peroralno suspenzijo, iz katerega po rekonstituciji z vodo dobimo belo peroralno suspenzijo z okusom grozdja.
English: Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125 mg twice daily with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63 % decrease of sildenafil AUC.
Slovenian: Sočasna uporaba bosentana (zmeren induktor CYP3A4, CYP2C9 in morda CYP2C19) v odmerku 125 mg dvakrat na dan in sildenafila v odmerku 80 mg trikrat na dan (v stanju dinamičnega ravnovesja), 6 dni pri zdravih prostovoljcih je povzročila 63 % zmanjšanje AUC sildenafila.
English: In the two-placebo controlled oral Revatio studies adverse events were generally mild to moderate in severity.
Slovenian: V teh dveh s placebom nadzorovanih študijah peroralnega zdravila Revatio so bili neželeni učinki na splošno blagi do zmerni.
English: In a specific interaction study, where oral sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Slovenian: V specifični interakcijski študiji, v kateri so hipertenzivni bolniki dobivali peroralni sildenafil (100 mg) sočasno z amlodipinom, se je sistolični krvni tlak v ležečem položaju dodatno znižal za 8 mmHg.
English: Revatio 20 mg film-coated tablets Sildenafil
Slovenian: Revatio 20 mg filmsko obložene tablete sildenafil
English: However, for subjects with PAH associated with connective tissue disease (36 subjects) mean changes from baseline were -18.32 m (95% CI:65.66 to 29.02) and 17.50 m (95% CI: -9.41 to 44.41) for the sildenafil and placebo groups, respectively.
Slovenian: Pri preiskovancih z boleznimi vezivnega tkiva povezano PAH (36 preiskovancev) pa je bila povprečna sprememba od izhodišča -18,32 m (95 % IZ: -65,66 do 29,02) v skupini s sildenafilom in 17,50 m (95 % IZ: -9,41 do 44,41) v skupini s placebom.
English: The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.
Slovenian: O naslednjih resnih neželenih učinkih, za katere menijo, da so povezani z zdravljenjem, so poročali občasno (pojavijo se lahko pri največ 1 od 100 bolnikov): alergijska reakcija (npr. kožni izpuščaj, otekanje obraza, ustnic in jezika, piskajoče dihanje, težave z dihanjem in požiranjem), epileptični krči, neredno bitje srca, okvara sluha, kratka sapa, vnetje prebavnega trakta, piskajoče dihanje zaradi motenega pretoka zraka.
English: - have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
Slovenian: - imate nepravilnost rdečih krvnih celic (srpastocelično anemijo), raka krvnih celic (levkemijo),
English: How to store Revatio
Slovenian: Kako uporabljati zdravilo Revatio
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Slovenian: Cimetidin (800 mg), zaviralec citokroma P450 in nespecifičen zaviralec CYP3A4, je ob sočasni uporabi s sildenafilom (50 mg) pri zdravih prostovoljcih povzročil 56 % povečanje koncentracije sildenafila v plazmi.
English: Oral sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
Slovenian: Peroralni sildenafil (50 mg) ni dodatno podaljšal časa krvavitve, podaljšanega zaradi acetilsalicilne kisline (150 mg).
English: Low dose (n=24)
Slovenian: Majhen odmerek (n = 24)
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale in na zunanji ovojnini poleg oznake »Uporabno do:«.
English: For patients with a baseline 6MWD < 325 m improved efficacy was observed with higher doses (placebo-corrected improvements of 58 metres, 65 metres and 87 metres for 20 mg, 40 mg and 80 mg doses TID, respectively).
Slovenian: Pri bolnikih z izhodiščnim 6MWD < 325 m je bila pri večjih odmerkih opažena povečana učinkovitost (za placebo korigirano izboljšanje je bilo za 20 mg sildenafila trikrat na dan 58 metrov, za 40 mg trikrat na dan 65 metrov in za 80 mg trikrat na dan 87 metrov).
English: In patients with pulmonary arterial hypertension, the average steady state concentrations were 20-50 % higher over the investigated dose range of 20-80 mg three times a day compared to healthy volunteers.
Slovenian: Pri bolnikih s pljučno arterijsko hipertenzijo je bila povprečna koncentracija v stanju dinamičnega ravnovesja v proučevanem območju od 20 do 80 mg trikrat na dan od 20 do 50 % večja kot pri zdravih prostovoljcih.
English: Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance < 30 ml/min).
Slovenian: Pri bolnikih z okvaro ledvic - tudi pri tistih s hudo okvaro (očistek kreatinina < 30 ml/min) - na začetku zdravljenja odmerka ni treba prilagoditi.
English: At single oral doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased.
Slovenian: Uporabo posamičnih odmerkov 200 mg je spremljala večja incidenca neželenih reakcij (glavobola, zardevanja, omotice, dispepsije, zamašenega nosu in sprememb vida).
English: In patients with pulmonary arterial hypertension, the average steady state concentrations were 20-50 % higher over the investigated oral dose range of 20-80 mg three times a day compared to healthy volunteers.
Slovenian: Pri bolnikih s pljučno arterijsko hipertenzijo je bila povprečna koncentracija v stanju dinamičnega ravnovesja v proučevanem območju peroralnega odmerka od 20 do 80 mg trikrat na dan od 20 do 50 % večja kot pri zdravih prostovoljcih.
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with oral sildenafil (50 mg) to healthy volunteers.
Slovenian: Cimetidin (800 mg), zaviralec citokroma P450 in nespecifičen zaviralec CYP3A4, je ob sočasni uporabi s peroralnim sildenafilom (50 mg) pri zdravih prostovoljcih povzročil 56 % povečanje koncentracije sildenafila v plazmi.
English: At the recommended oral dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen.
Slovenian: Ob priporočenem peroralnem odmerku 20 mg trikrat na dan niso opazili znižanja sistoličnega ali diastoličnega tlaka.
English: Note: A total volume of 90 ml (3 x 30 ml) of water irrespective of the dose to be taken should be used to reconstitute the contents of the bottle
Slovenian: Opomba: za rekonstitucijo vsebine steklenice je treba skupno uporabiti 90 ml (3 x 30 ml) vode, ne glede na odmerek, ki bo uporabljen.
English: The sildenafil medium and high dose groups both showed PVRI reductions compared to placebo, of 18 % (95 % CI: 2 % to 32 %) and 27 % (95 % CI: 14 % to 39 %), respectively; whilst the low dose group showed no significant difference from placebo (difference of 2 %).
Slovenian: Tako v skupini, ki je prejemala srednji odmerek, kot tudi v skupini, ki je prejemala velik odmerek sildenafila, so ugotovili zmanjšanje žilnega upora v pljučih v primerjavi s placebom, in sicer za 18 % (95 % IZ: 2 % do 32 %) oziroma 27 % (95 % IZ: 14 % do 39 %); medtem ko v skupini, ki je prejemala majhen odmerek, niso opazili nobene pomembne razlike v primerjavi s placebom (razlika v obsegu 2 %).
English: Microcrystalline cellulose Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate
Slovenian: Jedro tablete: mikrokristalna celuloza kalcijev hidrogenfosfat (brezvodni) premreženi natrijev karmelozat magnezijev stearat
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154 % and 87 %, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Slovenian: Poleg tega so pri preiskovancih s cirozo ugotovili pomembno večji AUC (za 154 %) in Cmax (za 87 %) N-dezmetilnega presnovka kot pri preiskovancih z normalnim delovanjem jeter.
English: Revatio 0.8 mg/ml solution for injection
Slovenian: Revatio 0,8 mg/ml raztopina za injiciranje
English: The PAH patients included those with Primary PAH, and PAH associated with connective tissue disease.
Slovenian: Med bolniki s PAH so bili takšni s primarno PAH in z boleznimi vezivnega tkiva povezano PAH.
English: A 10 mg dose of Revatio solution for injection is predicted to provide total exposure of free sildenafil and its N-desmethyl metabolite and their combined pharmacological effects comparable to those of a 20 mg oral dose.
Slovenian: Revatio raztopina za injiciranje v odmerku 10 mg predvidoma doseže takšno celotno izpostavljenost prostemu sildenafilu in njegovemu N-dezmetilnemu presnovku ter skupne farmakološke učinke, ki so primerljivi s peroralnim odmerkom 20 mg.
English: Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of oral sildenafil.
Slovenian: Sok grenivke šibko zavira presnovo s CYP3A4 v črevesni steni in lahko nekoliko poveča koncentracijo peroralnega sildenafila v plazmi.
English: figure 3
Slovenian: slika 3
English: If you miss a dose of Revatio
Slovenian: Če ste izpustili odmerek zdravila Revatio
English: figure 4
Slovenian: slika 4
English: Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Slovenian: S tem se sklada ugotovitev, da sildenafil okrepi hipotenzivno delovanje nitratov, zato je njegova sočasna uporaba z donorji dušikovega oksida ali nitrati v kakršnikoli obliki kontraindicirana (glejte poglavje 4.3).
English: Co-administration of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g) did not affect the pharmacokinetics of sildenafil.
Slovenian: Sočasna uporaba peroralnih kontraceptivov (30 g etinilestradiola in 150 g levonorgestrela) ni vplivala na farmakokinetiko sildenafila.
English: The total body clearance of sildenafil is 41 l/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80 % of administered oral dose) and to a lesser extent in the urine (approximately 13 % of administered oral dose).
Slovenian: Sildenafil se po peroralni in intravenski uporabi izloči v obliki presnovkov, pretežno v blatu (približno 80 % peroralnega odmerka) in v manjši meri v urinu (približno 13 % peroralnega odmerka).
English: - The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
Slovenian: Jedro tablete: mikrokristalna celuloza, brezvodni kalcijev hidrogenfosfat, premreženi natrijev karmelozat, magnezijev stearat.
English: figure 7
Slovenian: slika 7
English: Discard any remaining suspension 30 days after constitution.
Slovenian: Preostalo suspenzijo zavrzite v 30 dneh po rekonstituciji.
English: Side effects reported very commonly (may affect more than 1 in 10 people) were headache, vomiting, infection of the throat, fever, diarrhoea, flu and nosebleed.
Slovenian: Zelo pogosto opisani neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) so glavobol, bruhanje, okužba žrela, vročina, driska, gripa in krvavitev iz nosu.