FrancophonIA/ELRC3.0 huggingface dataset:
English: A variant form is angioedema of the intestine, which tends to occur within the first 24-48 hours of treatment.
Slovenian: Druga oblika je črevesni angioedem, ki se ponavadi pojavi v prvih 24 do 48 urah po zdravljenju.
English: Greece, Ireland, United Kingdom: Vascace Italy, Portugal: Inibace
Slovenian: Grčija, Irska, Velika Britanija: Vascace Italija, Portugalska: Inhibace
English: Roche Austria GmbH, Engelhorngasse 3, A - 1211 Vienna Austria
Slovenian: Roche Austria GmbH, Engelhorngasse 3, A - 1211 Vienna Avstrija
English: Therefore the CHMP was of the view that digitalis should not necessarily be mentioned because concomitant therapy with digitalis in general use (as a basic therapy) is not recommended today.
Slovenian: CHMP je zato menil, da digitalisa ni nujno treba omeniti, saj sočasno zdravljenje z digitalisom pri splošni uporabi (kot osnovno zdravljenje) danes ni priporočljivo.
English: Roche S.p.A Via G.B Stucchi 110 20052/Monza Italy
Slovenian: Roche S.p.A Via G.B Stucchi 110 20052/Monza Italija
English: indometacin and ibuprofen.
Slovenian: (aspirin), indometacin in ibuprofen.
English: In a careful literature search, covering the time period up to November 2009, only a single publication was identified, describing a case report of a patient with diabetic nephropathy and cirrhotic ascites.
Slovenian: Ob skrbnem pregledu literature do novembra 2009 je bilo mogoče odkriti le eno publikacijo, ki opisuje primer bolnika z diabetično nefropatijo in cirotičnim ascitesom.
English: Roche Bulgaria EOOD 16, Bvalo pole Str. 1618 / Sofia Bulgaria
Slovenian: Roche Bulgaria EOOD 16, Bvalo pole Str. 1618 / Sofia Bolgarija
English: - the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, so bili ocenjeni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora.
English: Vascace and associated names (see Annex I) 0.5 mg film-coated tablets Vascace and associated names (see Annex I) 1 mg film-coated tablets Vascace and associated names (see Annex I) 2.5 mg film-coated tablets Vascace and associated names (see Annex I) 5 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: Vascace in z njim povezana imena (Glejte Dodatek I) 0,5 mg filmsko obložene tablete Vascace in z njim povezana imena (Glejte Dodatek I) 1 mg filmsko obložene tablete Vascace in z njim povezana imena (Glejte Dodatek I) 2,5 mg filmsko obložene tablete Vascace in z njim povezana imena (Glejte Dodatek I) 5 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica]
English: Routine monitoring of potassium and creatinine is part of normal medical practice for these patients.
Slovenian: Redne kontrole kalija in kreatinina so del normalne zdravstvene oskrbe teh bolnikov.
English: Your doctor will then increase your dose until your blood pressure is under control.
Slovenian: Zdravnik vam bo potem odmerek povečeval, dokler krvni tlak ne bo urejen.
English: This helps to lower your blood pressure.
Slovenian: Tako pomaga znižati krvni tlak.
English: Although the study by Carlsen et al (Carlsen JE, Buchmann M, Hoeglund C, Pellinen T, Honkanen T, Soerensen OH, et al. 24-hour antihypertensive effect of oral cilazapril?
Slovenian: Čeprav se je na podlagi študije Carlsen et al (Carlsen JE, Buchmann M, Hoeglund C, Pellinen T, Honkanen T, Soerensen OH, et al. 24-hour antihypertensive effect of oral cilazapril?
English: If possible, diuretic therapy should be discontinued temporarily.
Slovenian: Če je mogoče, je treba zdravljenje z diuretikom začasno prekiniti.
English: The CHMP was of the view that specification (essential or according to updated definition - primary) and the grade (mild or moderate) of the hypertension should be omitted.
Slovenian: CHMP je menil, da je treba opustiti specifikacijo (esencialna ali - skladno s posodobljeno definicijoprimarna) in stopnjo (blaga ali zmerna) hipertenzije.
English: The dosing recommendation follows the “dosing by symptomatic relief” principle, which is not the current clinical practice.
Slovenian: Priporočeno odmerjanje se ravna po načelu „odmerjanje glede na lajšanje simptomov“, ki ni trenutna klinična praksa.
English: - Anaesthetics, narcotics.
Slovenian: - anestetike, narkotike.
English: Aortic stenosis/hypertrophic cardiomyopathy
Slovenian: Aortna stenoza/hipertrofična kardiomiopatija
English: Roche Pharma AG Emil-Barell-Strasse 1 79639/Grenzach Germany
Slovenian: Roche Pharma AG Emil-Barell-Strasse 1 79639/Grenzach Nemčija
English: Roche Farma S.A. Eucalipto n° 33 28016 / Madrid Spain
Slovenian: Roche Farma S.A. Eucalipto n° 33 28016 / Madrid Španija
English: Since the submission of the original documentation no additional studies were conducted by Roche in patients with impaired liver function.
Slovenian: Od predložitve izvirne dokumentacije dalje družba Roche ni izvedla dodatnih študij pri bolnikih z okvarjenim delovanjem jeter.
English: These include captopril, enalapril, lisinopril and ramipril.
Slovenian: Mednje spadajo kaptopril, enalapril, lizinopril in ramipril.
English: The combination should be administered with caution, especially in the elderly.
Slovenian: To kombinacijo zdravil je treba uporabljati previdno, še posebej pri starejših bolnikih.
English: Do not take Vascace - if you are allergic (hypersensitive) to cilazapril or any of the other ingredients of Vascace (listed in section 6: Further information).
Slovenian: Ne jemljite zdravila Vascace - če ste alergični (preobčutljivi) na cilazapril ali katerokoli sestavino zdravila Vascace (glejte poglavje 6: Dodatne informacije).
English: If you forget to take Vascace - If you forget to take a dose, skip the missed dose.
Slovenian: Če ste pozabili vzeti zdravilo Vascace - Če pozabite vzeti odmerek, pozabljeni odmerek preskočite.
English: In some patients blood pressure reduction may diminish towards the end of the dosage interval.
Slovenian: Pri nekaterih bolnikih se znižanje krvnega tlaka proti koncu odmernega intervala lahko zmanjša.
English: Do not use Vascace after the expiry date which is stated on the pack.
Slovenian: Zdravila Vascace ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju.
English: However, racial differences in response are no longer evident when Vascace is administered in combination with hydrochlorothiazide.
Slovenian: Rasne razlike v odzivu pa niso več opazne, če je zdravilo Vascace uporabljeno v kombinaciji s hidroklorotiazidom.
English: If hypotension occurs, the patient should be placed in the shock position.
Slovenian: Če se pojavi hipotenzija, je bolnika treba položiti v položaj za šok.
English: This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment.
Slovenian: To je verjetneje v prvih tednih kombiniranega zdravljenja in pri bolnikih z okvaro ledvic.
English: (a) Summary of the safety profile
Slovenian: (a) Povzetek varnostnih značilnosti
English: 6.6 Special precautions for disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: - Insulin or other medicines used to treat diabetes.
Slovenian: - insulin ali druga zdravila za zdravljenje sladkorne bolezni.
English: You must tell your doctor if you think you are (or might become) pregnant.
Slovenian: Zdravniku morate povedati, če mislite, da ste noseči.
English: It may be resumed later if required.
Slovenian: Po potrebi je njihovo jemanje mogoče nadaljevati pozneje.
English: - if you have diabetes.
Slovenian: - če imate sladkorno bolezen.
English: Common ≥ 1/100 and < 1/10
Slovenian: ≥ 1/100 in < 1/10
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - Diuretics (‘water tablets') - see ‘High blood pressure (hypertension)' in section 3 on ‘How to take Vascace'.
Slovenian: Še zlasti morate zdravniku ali farmacevtu povedati, če jemljete katero od naslednjih zdravil: - diuretike ("tablete za odvajanje vode") - glejte "Visok krvni tlak (hipertenzija)" v poglavju 3,
English: - Lithium (used to treat depression).
Slovenian: - litij (uporablja se za zdravljenje depresije).
English: The antihypertensive effect of Vascace is usually apparent within the first hour after administration, with maximum effect observed between 3 and 7 hours after dosing.
Slovenian: Antihipertenzivni učinek zdravila Vascace je ponavadi opazen v prvi uri po uporabi, največji učinek pa od 3 do 7 ur po uporabi.
English: Vascace should be administered once daily.
Slovenian: Zdravilo Vascace je treba uporabljati enkrat na dan.
English: - if you have recently been vomiting or have had diarrhoea.
Slovenian: - če ste pred kratkim bruhali ali ste imeli drisko.
English: Furthermore, the exercise tolerance of these patients increases significantly.
Slovenian: Poleg tega se tem bolnikom bistveno poveča prenašanje telesne obremenitve.
English: If you take more Vascace than you should, or if someone else takes your Vascace tablets, talk to a doctor or go to a hospital straight away.
Slovenian: Če vzamete več zdravila Vascace, kot bi smeli, ali če vaše tablete Vascace vzame kdo drug, se takoj posvetujte z zdravnikom ali pojdite v bolnišnico.
English: Your doctor will normally advise you to stop taking Vascace before you become pregnant, or as soon as you know you are pregnant, and will advise you to take another medicine instead of Vascace.
Slovenian: Zdravnik vam bo praviloma svetoval, da nehajte jemati zdravilo Vascace, preden zanosite, ali čim ugotovite, da ste noseči, in vam bo namesto zdravila Vascace svetoval neko drugo zdravilo.
English: Reflex tachycardia is not induced, although small, clinically insignificant alterations of heart rate may occur.
Slovenian: Refleksna tahikardija se ne pojavi, pojavijo pa se lahko majhne, klinično nepomembne spremembe srčne frekvence.
English: - if you have a collagen vascular disease.
Slovenian: - če imate kolagensko žilno bolezen.
English: Estimates of frequency are based on the proportion of patients reporting each adverse reaction during cilazapril clinical trials that included a total combined population of 7171 patients.
Slovenian: Ocene pogostnosti temeljijo na deležu bolnikov, pri katerih se je pojavil posamezen neželen učinek med kliničnimi preskušanji s cilazaprilom, ki so v celoti zajela kombinirano populacijo 7.171 bolnikov.
English: Vascace was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Slovenian: Zdravilo Vascase je bilo vključeno na seznam zdravil za uskladitev Povzetka glavnih značilnosti zdravila, ki ga je pripravila Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini CMD(h) v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena.
English: Blood pressure should be assessed, and dosage adjusted individually in accordance with the blood pressure response.
Slovenian: Krvni tlak je treba kontrolirati in odmerjanje individualno prilagoditi odzivu krvnega tlaka.
English: Therefore, caution should be exercised in these patients.
Slovenian: Te bolnike je torej treba zdraviti previdno.
English: The demographic data justifies the efficacy in patients of various age, gender, and weight with mild to moderate primary hypertension.
Slovenian: Demografski podatki utemeljujejo njegovo učinkovitost pri bolnikih različnih starosti, spola in telesne mase z blago do zmerno primarno hipertenzijo.
English: - if you are allergic (hypersensitive) to other ACE inhibitor medicines.
Slovenian: - če ste alergični (preobčutljivi) na druge zaviralce ACE.
English: Important information about some of the ingredients of Vascace Vascace contains lactose, which is a type of sugar.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Vascace Zdravilo Vascace vsebujejo laktozo, ki je vrsta sladkorja.
English: Member State EU Marketing Authorisation Holder
Slovenian: Država članica EU Imetnik dovoljenja za promet z zdravilom
English: Nevertheless, as there are no outcome studies to provide a definite beneficial dose for the majority of patients, and since the MAH has not been able to provide a better dosing guide based e.g. on pharmacokinetic/pharmacodynamic data, the following wording proposed by the MAH, was considered to be acceptable by the CHMP.
Slovenian: Glede na to, da ni rezultatov študij, ki bi dokazali dokončen koristen odmerek za večino bolnikov, in ker imetnik dovoljenja za promet z zdravilom ni uspel predložiti boljšega načina odmerjanja, na primer na podlagi podatkov o farmakokinetiki/farmakodinamiki, je CHMP štel za sprejemljivo naslednje besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom.
English: Vascace is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Uporaba zdravila Vascace v zgodnji nosečnosti ni priporočljiva, ne smete pa ga jemati, če ste noseči dlje kot 3 mesece, ker lahko resno škoduje otroku, če se ga uporablja po tretjem mesecu nosečnosti.
English: Uncommon ≥ 1/1,000 and < 1/100
Slovenian: ≥ 1/1.000 in < 1/100
English: Also some medicines can affect the way Vascace works.
Slovenian: Tudi nekatera zdravila lahko vplivajo na delovanje zdravila Vascace.
English: If this dose has been well tolerated it may be increased in weekly intervals and according to the clinical status of the patient to 1.0 mg or 2.5 mg.
Slovenian: Če bolnik ta odmerek dobro prenaša, ga je mogoče povečevati v tedenskih intervalih in v skladu s kliničnim stanjem bolnika na 1,0 mg ali 2,5 mg.
English: If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.
Slovenian: Če je sočasna uporaba indicirana zaradi potrjene hipokaliemije, jih je treba uporabljati previdno in pogosto spremljati serumske koncentracije kalija.
English: This is because some anaesthetics can lower your blood pressure, and it may become too low.
Slovenian: Nekateri anestetiki namreč lahko znižajo krvni tlak, ki zaradi tega lahko preveč pade.
English: Antidiabetics
Slovenian: Antidiabetiki
English: The concept of adjunctive therapy with digitalis and diuretics is not supported by the current evidence on ACE inhibitors and clinical guidance documents on the management of CHF.
Slovenian: Koncept dodatnega zdravljenja z digitalisom in diuretiki ni podprt s trenutnimi dokazi o zaviralcih ACE in dokumenti s kliničnimi smernicami glede obvladovanja kroničnega srčnega popuščanja.
English: (b) Tabulated list of adverse reactions
Slovenian: (b) Tabelirani seznam neželenih učinkov
English: - Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions 2006.
Slovenian: V večini primerov sta vir referenc: - Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions (Neželeni učinki zdravil: Mednarodna enciklopedija neželenih učinkov in medsebojnih učinkov) 2006.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction The most important possible interactions (PK, PD or toxic) have been included in the harmonized label, since these drugs are frequently co-prescribed with cilazapril or other ACE inhibitors and scientific rationale is available.
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Najpomembnejše možne interakcije (farmakokinetične, farmakodinamične ali toksične) so vključene v usklajenem označevanju, saj se ta zdravila pogosto predpisujejo skupaj s cilazaprilom ali drugimi zaviralci ACE, na voljo pa je tudi znanstvena razlaga.
English: The CHMP was of the view that renovascular hypertension should not be included as an independent indication, as the MAH was unable to substantiate it with their own clinical data.
Slovenian: CHMP je menil, da renovaskularna hipertenzija ne sme biti vključena kot neodvisna indikacija, saj je imetnik dovoljenja za promet z zdravilom ni uspel podkrepiti z lastnimi kliničnimi podatki.
English: Vascace is used to treat the following: - High blood pressure (hypertension) - Chronic (long-term) heart failure.
Slovenian: Zdravilo Vascace se uporablja za zdravljenje: - visokega krvnega tlaka (hipertenzije), - kroničnega (dolgotrajnega) srčnega popuščanja.
English: The antihypertensive effect of Vascace is maintained during long-term therapy.
Slovenian: Antihipertenzivni učinek zdravila Vascace se med dolgotrajnim zdravljenjem ohrani.
English: Section 4.4 - Special warnings and precautions for use With a few exceptions, the scientific basis for the proposed text in Section 4.4 is provided by reviews of adverse effects of ACE inhibitors found in the following texts: Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions 2006 and the Martindale: The Complete Drug Reference 36.
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Znanstveno podlago predlaganega besedila v poglavju 4.4 so z nekaterimi izjemami zagotovili pregledi neželenih učinkov zaviralcev ACE v naslednjih besedilih: Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions (Neželeni učinki zdravil: Mednarodna enciklopedija neželenih učinkov in medsebojnih učinkov) 2006 in Martindale: The Complete Drug Reference 36 (Celotne reference o zdravilih, 36. izdaja).
English: The recommended treatment of overdosage is intravenous infusion of sodium chloride 9 mg/ml (0.9%) solution.
Slovenian: V primeru prevelikega odmerjanja je priporočljiva intravenska infuzija raztopine natrijevega klorida 9 mg/ml (0,9 %).
English: Sympathomimetics Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Slovenian: Simpatikomimetiki Simpatikomimetiki lahko zmanjšajo antihipertenzivne učinke zaviralcev ACE.
English: The CHMP was of the view that the prescriber needs to be made aware that only symptomatic benefit has been demonstrated in clinical trials with cilazapril in heart failure and that no morbidity/mortality results are available, since outcome studies with cilazapril in chronic heart failure have not been performed.
Slovenian: CHMP je menil, da je treba zdravnika, ki je predpisal zdravilo, seznaniti s tem, da so bile v kliničnih preskušanjih dokazane le simptomatske koristi cilazaprila pri srčnem popuščanju in da rezultati obolevnosti/umrljivosti niso na voljo, saj študije, iz katerih bi bili razvidni rezultati s cilazaprilom pri kroničnem srčnem popuščanju, niso bile izvedene.
English: Vascace is not recommended for use in children.
Slovenian: Zdravila Vascace ni priporočljivo uporabljati pri otrocih.
English: - Swallow each tablet with a drink of water.
Slovenian: - Tableto pogoltnite z nekaj vode.
English: This is because Vascace can affect the way some medicines work.
Slovenian: Zdravilo Vascace namreč lahko vpliva na delovanje nekaterih zdravil.
English: Relatively limited evidence-based information is available on treatment of renovascular hypertension with ACE inhibitors (especially with cilazapril), but it cannot be ignored that ACE inhibitors are considered by many experts as effective medication for treatment of this condition.
Slovenian: Dokaj omejeni dokazi so na voljo o zdravljenju renovaskularne hipertenzije z zaviralci ACE (zlasti s cilazaprilom), vendar ni mogoče prezreti dejstva, da so zaviralci ACE po mnenju mnogih strokovnjakov učinkovito zdravilo za zdravljenje tega zdravstvenega stanja.
English: Elderly patients: In elderly patients whose renal function is normal for age, plasma concentrations of cilazaprilat may be up to 40% higher and clearance 20% lower, than in younger patients.
Slovenian: Starejši bolniki: Pri starejših bolnikih, ki imajo za starost normalno delovanje ledvic, je lahko koncentracija cilazaprilata v plazmi do 40 % večja, očistek pa 20 % manjši kot pri mlajših bolnikih.
English: If renovascular hypertension is also present there is an increased risk of severe hypotension and renal insufficiency.
Slovenian: Če je prisotna tudi renovaskularna hipertenzija, obstaja večje tveganje hude hipotenzije in insuficience ledvic.
English: When driving and operating machines, it should be taken into account that occasionally dizziness and fatigue may occur, especially when starting therapy (see sections 4.4 and 4.8).
Slovenian: V primeru vožnje in upravljanja s stroji je treba upoštevati, da se lahko občasno pojavita omotica in utrujenost, zlasti na začetku zdravljenja (glejte poglavji 4.4 in 4.8).
English: If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered.
Slovenian: Če je na voljo, je mogoče tudi zdravljenje z infuzijo angiotenzina II in/ali intravensko dajanimi kateholamini.
English: The efficacy of cilazapril in the treatment of hypertension has been documented in several clinical trials sponsored by Roche.
Slovenian: Učinkovitost cilazaprila pri zdravljenju hipertenzije je bila dokazana v več kliničnih preskušanjih, ki jih je sponzorirala družba Roche.
English: Treatment-related adverse events severe enough to stop treatment occur in less than 5% of patients receiving ACE inhibitors.
Slovenian: Z zdravljenjem povezani neželeni učinki, ki so dovolj hudi, da zahtevajo prenehanje zdravljenja, se pojavijo pri manj kot 5 % bolnikov, zdravljenih z zaviralci ACE.
English: Due to the large variety of possible clinical situations for cirrhotic patients, conditions exist where patients require a carefully supervised treatment with cilazapril.
Slovenian: Zaradi najrazličnejših možnih kliničnih stanj pri bolnikih s cirozo je v nekaterih primerih pri bolnikih potrebno skrbno nadzorovano zdravljenje s cilazaprilom.
English: Then take the next dose when it is due.
Slovenian: Potem vzemite naslednji odmerek,
English: Considering the data from cilazapril trials conducted as part of the clinical development program for Vascace, the published data on the therapeutic effect of ACE inhibitors on CHF, and the Guidelines of the European Society of Cardiology, the CHMP agreed with the following wording proposed by the MAH for this indication:
Slovenian: Ob upoštevanju podatkov iz preskušanj s cilazaprilom, ki so bila izvedena kot del programa kliničnega razvoja za zdravilo Vascase, objavljenih podatkov o terapevtskem učinku zaviralcev ACE pri kroničnem srčnem popuščanju ter smernic Evropskega kardiološkega združenja se je CHMP strinjal z naslednjim besedilom, ki ga je za to indikacijo predlagal imetnik dovoljenja za promet z zdravilom:
English: - Gold compounds (used to treat rheumatoid arthritis).
Slovenian: - pripravke z zlatom (uporabljajo se za zdravljenje revmatoidnega artritisa).
English: Like all medicines, Vascace can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Vascace neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: Tricyclic antidepressants/antipsychotics/anesthetics/narcotics Concomitant use of certain anesthetic medicinal products, tricyclic antidepressants and antipsychotics with ACE inhibitors may result in further reduction of blood pressure (see section 4.4).
Slovenian: Triciklični antidepresivi/antipsihotiki/anestetiki/narkotiki Sočasna uporaba določenih anestetikov, tricikličnih antidepresivov in antipsihotikov z zaviralci ACE lahko dodatno zniža krvni tlak (glejte poglavje 4.4).
English: - Low numbers of platelets in your blood.
Slovenian: - majhno število krvnih ploščic (trombocitov) v krvi.