FrancophonIA/ELRC3.0 huggingface dataset:
English: The initial dose for the Diovan oral solution is 20 mg (corresponding to 7 ml of the solution) once daily for children below 35 kg of weight and 40 mg (corresponding to 13 ml of the solution) once daily for those weighing 35 kg or more.
Slovenian: Pri uporabi Diovan peroralne raztopine je za otroke s telesno maso pod 35 kg začetni odmerek 20 mg (kar ustreza 7 ml raztopine) enkrat na dan, za otroke s telesno maso 35 kg ali več pa 40 mg (kar ustreza 13 ml raztopine) enkrat na dan. Odmerek je treba prilagoditi glede na odziv krvnega tlaka, vendar največ do 80 mg valsartana (kar ustreza 27 ml raztopine).
English: Your doctor will normally advise you to stop taking Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan.
Slovenian: Zdravnik vam bo praviloma svetoval jemanje drugega zdravila namesto zdravila Diovan, saj jemanje zdravila Diovan v zgodnjem obdobju nosečnosti ni priporočljivo in lahko po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
English: Renal function and serum potassium should be closely monitored.
Slovenian: Pri tem je treba natančno spremljati delovanje ledvic in vrednosti kalija v serumu.
English: INSTRUCTIONS ON USE [To be completed nationally] 16.
Slovenian: NAVODILA ZA UPORABO [Izpolni država članica]
English: Excretion:
Slovenian: Izločanje:
English: Methyl parahydroxybenzoate
Slovenian: Metilparahidroksibenzoat
English: • spinning sensation (vertigo)
Slovenian: • občutek vrtenja (vrtoglavica)
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min.
Slovenian: Pri pediatričnih bolnikih z očistkom kreatinina > 30 ml/min odmerkov ni treba prilagajati.
English: Renal and urinary disorders, and obesity were the most common underlying medical conditions potentially contributing to hypertension in the children enrolled in these studies.
Slovenian: Med osnovnimi boleznimi, ki bi pri otrocih v teh študijah lahko prispevale k razvoju hipertenzije, so bile najbolj pogoste bolezni sečil in debelost.
English: Hypotension, Orthostatic hypotension
Slovenian: Žilne bolezni pogosti hipotenzija, ortostatska hipotenzija neznana vaskulitis
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
Slovenian: Pri sočasni uporabi z zaviralci ACE so poročali o reverzibilnem zvišanju koncentracije litija v serumu in o toksičnosti.
English: Excipients:
Slovenian: Merica:
English: Diabetes
Slovenian: Sladkorna bolezen
English: • Tell your doctor if you are breast-feeding or about to start breast-feeding.
Slovenian: • Povejte svojemu zdravniku, če dojite ali nameravate začeti dojiti.
English: Pharmaceutical Form Route of administration
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe
English: Because no information is available regarding the use of valsartan during breastfeeding, Diovan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Boljša izbira so alternativna zdravila z uveljavljenim boljšim varnostnim profilom za uporabo med dojenjem, še zlasti pri dojenju novorojenčka ali nedonošenčka.
English: Artificial blueberry flavour (538926 C) Propylene glycol (E1520) Sodium hydroxide
Slovenian: 6.1 Seznam pomožnih snovi saharoza metilparahidroksibenzoat (E218) kalijev sorbat poloksamer (188) citronska kislina, brezvodna natrijev citrat umetna aroma borovnice (538926 C) propilenglikol (E1520) natrijev hidroksid klorovodikova kislina prečiščena voda
English: Valsartan dose to provide when switching
Slovenian: tablete raztopina odmerek valsartana odmerek valsartana ob prehodu volumen zdravila, ki ga je treba vzeti
English: P-2710-444 Sintra
Slovenian: Quinta da Beloura P-2710-444 Sintra (Tel: +351 21 000 86 00)
English: Decrease in haemoglobin, Decrease in haematocrit, Neutropenia, Thrombocytopenia
Slovenian: Bolezni krvi in limfatičnega sistema neznana znižana koncentracija hemoglobina, zmanjšanje hematokrita, nevtropenija, trombocitopenija
English: EU/EEA Marketing Authorisation Holder
Slovenian: Imetnik dovoljenja za promet z
English: Available data are described in sections 4.8, 5.1 and 5.2.
Slovenian: Razpoložljivi podatki so navedeni v poglavjih 4.8, 5.1 in 5.2, vendar varnost in učinkovitost zdravila Diovan pri otrocih, ki so stari od 1 leta do 6 let, nista dokazani.
English: Elevation of liver function values including increase of serum bilirubin
Slovenian: Bolezni jeter, žolčnika in žolčevodov neznana zvišane vrednosti jetrnih testov vključno z zvišano koncentracijo bilirubina v serumu
English: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley
Slovenian: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44-1276-69 22 55)
English: Impaired hepatic function
Slovenian: Okvarjeno delovanje ledvic
English: Please read the instructions at the end of this leaflet before you use the oral syringe or the dosing cup.
Slovenian: Preden začnete uporabljati brizgo za peroralno dajanje in merico, preberite navodila na koncu tega Navodila za uporabo.
English: Diovan 160 mg pl vele dengtos tablets
Slovenian: Diovan 160 mg plėvele dengtos tabletės
English: Musculoskeletal and connective tissue disorders Not known
Slovenian: Bolezni mišično-skeletnega sistema neznana mialgija
English: FIN-02130 Espoo Finland (Tel: + 358-9-6133 22 11)
Slovenian: Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland (Tel: + 358-9-6133 22 11)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 3 mg of valsartan.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En mililiter vsebuje 3 mg valsartana.
English: • The oral syringe fits into the bottle adapter and is used to measure out the required amount of medicine from the bottle.
Slovenian: Uporabljamo jo za odmerjanje količine zdravila, ki ga moramo vzeti iz steklenice.
English: Acute renal failure, Elevation of serum creatinine
Slovenian: Presnovne in prehranske motnje neznana zvišana koncentracija kalija v serumu
English: Renal failure and impairment, Elevation of serum creatinine General disorders and administration site conditions Uncommon
Slovenian: Bolezni sečil neznana odpoved ali okvara ledvic, zvišana koncentracija kreatinina v serumu Splošne težave in spremembe na mestu aplikacije občasni utrujenost
English: Respiratory, thoracic and mediastinal disorders Uncommon
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasni kašelj
English: Diovan 80 mg pl vele dengtos tablets
Slovenian: Diovan 80 mg plėvele dengtos tabletės
English: 92500 RUEIL-MALMAISON
Slovenian: 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON (Tel: +33-1-5547 60 00 )
English: A press in bottle adapter:
Slovenian: Pritisni nastavek za steklenico:
English: Angioedema, Rash, Pruritus
Slovenian: • koprivnica, srbenje
English: Angiosan 80 mg Filmtabletten 80 mg
Slovenian: Angiosan 80 mg Filmtabletten 80 mg filmsk obložene tablete
English: Diovan 320 mg pl vele dengtos tablets
Slovenian: Diovan 320 mg plėvele dengtos tabletės
English: Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Slovenian: Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen, če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
English: Cardiac failure
Slovenian: Srčne bolezni občasni odpoved srca
English: • Diovan solution contains poloxamer (188).
Slovenian: • Diovan raztopina vsebuje poloksamer (188), ki lahko povzroči odvajanje mehkejšega blata.
English: • nausea
Slovenian: • navzea
English: Skin and subcutaneous tissue disorders Uncommon
Slovenian: Bolezni kože in podkožja občasni angioedem neznana izpuščaj, pruritus
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA/NALEPKA NA STEKLENICI
English: Take Diovan solution once a day
Slovenian: Koliko zdravila je treba jemati Diovan raztopino jemljite enkrat na dan.
English: If any of the side effects gets serious.
Slovenian: Če kateri od neželenih učinkov postane resen, obvestite zdravnika.
English: Surrey GU16 7SR (Tel: +44-1276-69 22 55)
Slovenian: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR (Tel: +44-1276-69 22 55)
English: • purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)
Slovenian: • škrlatno-rdeči madeži, zvišana telesna temperatura, srbenje (znaki vnetja krvnih žil,
English: To clean the cup:
Slovenian: Čiščenje merice:
English: Lactation
Slovenian: Odmerjanje
English: Change of pharmaceutical form
Slovenian: Prehajanje z ene oblike zdravila na drugo
English: Invented name
Slovenian: IME ZDRAVILA
English: Citric acid, anhydrous Sodium citrate
Slovenian: natrijev hidroksid, klorovodikova kislina, prečiščena voda.
English: Always take Diovan exactly as your doctor has told you in order to get the best results and reduce the risk of side effects.
Slovenian: Tako bodo rezultati najboljši in tveganje neželenih učinkov najmanjše.
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] 15.
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica]
English: BEFORE YOU TAKE DIOVAN
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO DIOVAN
English: • dizziness
Slovenian: • omotičnost
English: • abdominal pain
Slovenian: • bolečine v trebuhu
English: If necessary you may receive additional salts.
Slovenian: Če bo potrebno, boste lahko prejeli dodatne soli.
English: In addition it will be ensured that you receive enough fluids.
Slovenian: Poleg tega bodo poskrbeli, da boste prejeli dovolj tekočin.
English: The maximum recommended daily dose must not be exceeded.
Slovenian: Največjega priporočenega dnevnega odmerka se ne sme preseči.
English: Your doctor will use the lowest possible effective dose and will not infuse <Product name> for more than 24 hours.
Slovenian: Zdravnik bo uporabil najnižji možni učinkovit odmerek in ne bo infundiral zdravila <Ime zdravila> več kot 24 ur.
English: The product information shall be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Pristojni organi držav članic bodo kasneje, v povezavi z referenčno državo članico, posodobili Informacije o zdravilu, kot je primerno, v skladu s postopki, ki jih določa Poglavje 4, Naslov III Direktive 2001/83/ES.
English: What you need to know before you use <Product name>
Slovenian: Kaj morate vedeti, preden boste uporabili <Ime zdravila>
English: The lowest possible effective dose should be applied.
Slovenian: Uporabiti moramo najmanjši učinkoviti odmerek.
English: Frequency not known (cannot be estimated from the available data)
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
English: Your doctor will decide on the correct dose for you to receive.
Slovenian: Zdravnik se bo odločil o pravilnem odmerku, ki ga boste prejeli.
English: Section 4.3 Contraindications
Slovenian: Poglavje 4.3 Kontraindikacije
English: • have too much fluid in your body and you have been told that you have a condition known as hyperhydration
Slovenian: • če imate preveč tekočine v telesu in so vam povedali, da je vaše stanje znano kot hiperhidracija
English: By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: The maximum daily dose is <30ml/kg for 6% HES (130/0.40) and 6% HES (130/0.42); for other HES products the maximum daily dose should be recalculated accordingly>.
Slovenian: Največji dnevni odmerek je <30 ml/kg za HES 60 mg/ml (130/0,40) in HES 60 mg/ml (130/0,42); za druga zdravila, ki vsebujejo HES, je treba največji dnevni odmerek ustrezno preračunati>.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V*.
English: • are critically ill (e.g. you need to stay in an intensive care unit)
Slovenian: • če ste kritično bolni (npr. morate ostati v enoti za intenzivno terapijo)
English: Therefore it is not recommended to use this medicine in children.
Slovenian: Zato se ne priporoča uporabe tega zdravila pri otrocih.
English: - hyperkalaemia [only applicable to products containing potassium]
Slovenian: • hiperkaliemija [velja samo za zdravila, ki vsebujejo kalij]
English: • suffer from serious generalised infection (sepsis)
Slovenian: • če imate resno splošno okužbo (sepso)
English: Monitoring of renal function in patients is recommended for at least 90 days.
Slovenian: Delovanje ledvic pri bolnikih je priporočljivo spremljati vsaj 90 dni.
English: In the case of repeated administration, blood coagulation parameters should be monitored carefully.
Slovenian: V primeru ponovnega dajanja je treba skrbno spremljati parametre strjevanja krvi.
English: The first 10-20 ml should be infused slowly and under careful monitoring of the patient so that any anaphylactoid reaction can be detected as early as possible.
Slovenian: Prvih 10-20 ml moramo infundirati počasi in skrbno spremljati bolnika, tako da čim prej odkrijemo kakršno koli anafilaktoidno reakcijo.
English: The dosage must be adjusted carefully, particularly in patients with pulmonary and cardiocirculatory problems.
Slovenian: Odmerjanje je treba natančno prilagoditi, zlasti pri bolnikih s pljučnimi in kardiocirkulatornimi težavami.
English: See the end of section 4 for how to report side effects.
Slovenian: Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.>
English: See section 4.8 for how to report adverse reactions.>
Slovenian: Glejte poglavje 4.8, kako poročati o neželenih učinkih.>
English: How to use <Product name>
Slovenian: Kako uporabljati zdravilo <Ime zdravila>
English: The use of HES must be discontinued at the first sign of renal injury.
Slovenian: Uporabo HES je treba prekiniti ob prvem znaku poškodbe ledvic.
English: • are dehydrated
Slovenian: • če ste dehidrirani
English: If impaired kidney function occurs during therapy:
Slovenian: Če se okvarjeno delovanje ledvic pojavi med zdravljenjem:
English: • are allergic to any of the active substances or any of the other ingredients of this medicine
Slovenian: • če ste alergični na zdravilne učinkovine ali katero koli sestavino tega zdravila
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Slovenian: Priloga III Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
English: The relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Slovenian: Ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
English: What <Product name> is and what it is used for [This section should be amended to include the below wording] <Product name> is a plasma volume substitute that is used to restore the blood volume when you have lost blood when other products called crystalloids are not considered sufficient alone.
Slovenian: Kaj je zdravilo <Ime zdravila> in za kaj ga uporabljamo [To poglavje je treba spremeniti tako, da se vključi naslednje besedilo] Zdravilo <Ime zdravila> je nadomestek volumna plazme, ki se uporablja za ponovno vzpostavitev volumna krvi pri izgubi le te, ko druga zdravila, ki se imenujejo kristaloidi, ne zadoščajo.
English: Because of the risk of allergic (anaphylactic/anaphylactoid) reactions, you will be monitored closely to detect early signs of an allergic reaction when you receive this medicine.
Slovenian: Zaradi tveganja za alergijske (anafilaktične/anafilaktoidne) reakcije, vas bodo skrbno spremljali, ko boste prejeli to zdravilo, da ugotovijo zgodnje znake alergičnih reakcij.
English: I. Summary of Product Characteristics <This medicinal product is subject to additional monitoring.
Slovenian: I. Povzetek glavnih značilnosti zdravila < Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Hepatic injury < frequency not known (cannot be estimated from the available data)> Renal injury < frequency not known (cannot be estimated from the available data)>
Slovenian: Poškodba jeter <neznana (ni mogoče oceniti iz razpoložljivih podatkov)> Poškodba ledvic <neznana (ni mogoče oceniti iz razpoložljivih podatkov)>
English: If you are given <Product name> repeatedly your doctor will monitor the ability of your blood to clot, bleeding time and other functions.
Slovenian: Če večkrat prejemate odmerke zdravila <Ime zdravila>, bo zdravnik spremljal strjevanje vaše krvi, čas krvavitve in druge funkcije.
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Slovenian: Poročali so o povečani potrebi po nadomestnem ledvičnem zdravljenju v obdobju 90 dni po dajanju HES.
English: There is only limited experience of the use of this medicine in children.
Slovenian: Obstaja zgolj omejena izkušnja uporabe pri otrocih.
English: Volume overload due to overdose or too rapid infusion must always be avoided.
Slovenian: Vedno se je potrebno izogniti preobremenitvi volumna zaradi prevelikega odmerjanja ali prehitrega infundiranja.
English: The expected benefit of treatment should be carefully weighed against uncertainty with regard to this long term safety.
Slovenian: Pričakovano korist zdravljenja je treba skrbno pretehtati glede na negotovost dolgoročne varnosti ter upoštevati druge razpoložljive možnosti zdravljenja.
English: The nursing staff will also take measures to observe your body's fluid balance, blood salt level, and kidney function.
Slovenian: Negovalno osebje bo tudi sprejelo ukrepe za spremljanje vašega ravnovesja tekočin, koncentracije soli v krvi in delovanja ledvic.
English: • have been told that you have a severe increase of potassium [Note: only for products which contain potassium], sodium or chloride in your blood
Slovenian: • če so vam povedali, da imate močno povečano koncentracijo kalija [Opomba: samo za zdravila, ki vsebujejo kalij], natrija ali klorida v krvi
English: [This section should be amended to include the following contraindications]
Slovenian: [To poglavje je treba spremeniti tako, da se vključi naslednje kontraindikacije]
English: In patients undergoing open heart surgery in association with cardiopulmonary bypass the use of HES products is not recommended due to the risk of excess bleeding.
Slovenian: Pri bolnikih z operacijo na odprtem srcu v povezavi s kardiopulmonalnim obvodom se uporaba zdravil, ki vsebujejo HES, ne priporoča zaradi tveganja prekomerne krvavitve.
English: Section 4.8 Undesirable effects [This following wording should be reflected in this section]
Slovenian: Poglavje 4.8 neželeni učinki [To poglavje je treba spremeniti, da odraža naslednje besedilo]
English: • suffer from bleeding in the brain (intracranial or cerebral bleeding)
Slovenian: • če imate možgansko krvavitev (intrakranialno ali cerebralno krvavitev)
English: Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved.
Slovenian: Zdravljenje mora temeljiti na kontinuiranem spremljanju hemodinamike in infundiranje je treba prekiniti takoj, ko se doseže ustrezna hemodinamika.
English: In addition your doctor may need to monitor your kidney function for up to 90 days.
Slovenian: Poleg tega bo morda zdravnik še 90 dni spremljal delovanje vaših ledvic.
English: <Product name> is contraindicated if you have kidney impairment or of kidney injury requiring dialysis.
Slovenian: Zdravilo <Ime zdravila> je kontraindicirano, če imate okvarjeno delovanje ledvic ali poškodbo ledvic, pri kateri je potrebna dializa.
English: • have severe problems with your blood clotting
Slovenian: • če imate hude težave s strjevanjem krvi
English: Because of the risk of allergic (anaphylactoid) reactions, the patient should be monitored closely and the infusion instituted at a low rate (see section 4.8).
Slovenian: Zaradi tveganja alergijskih (anafilaktoidnih) reakcij je potrebno bolnike pozorno spremljati in zdravilo infundirati počasi (glejte poglavje 4.8).
English: Particular caution should be exercised when treating patients with impaired hepatic function or in patients with blood coagulation disorders.
Slovenian: Posebna previdnost je potrebna pri zdravljenju bolnikov z okvarjenim delovanjem jeter ali pri bolnikih z motnjami strjevanja krvi.
English: If you are undergoing open heart surgery and you are on a heart-lung machine to assist in pumping your blood during the surgery, the administration of this solution is not recommended.
Slovenian: Če imate operacijo na odprtem srcu in ste priključeni na aparat srce-pljuča, ki pomaga črpati vašo kri med kirurškim posegom, se uporabe te raztopine ne priporoča.
English: [This section should be amended to reflect the following wording]
Slovenian: [To poglavje je treba spremeniti, da odraža naslednje besedilo]
English: Dosage
Slovenian: • sepsa
English: If the doctor detects first signs of kidney impairment he/she will stop giving you this medicine.
Slovenian: Če je zdravnik ugotovil prve znake okvarjenega delovanja ledvic, se bo odločil za ukinitev dajanja tega zdravila.
English: • have fluid in the lungs (pulmonary oedema)
Slovenian: • če imate tekočino v pljučih (pljučni edem)
English: Serum electrolytes, fluid balance and renal function should be monitored closely.
Slovenian: Pozorno je treba spremljati koncentracije elektrolitov v serumu, ravnovesje tekočin in delovanje ledvic.
English: Do not use <Product name> if you:
Slovenian: Zdravila <Ime zdravila> ne boste prejeli:
English: Surgery and trauma:
Slovenian: Kirurški posegi in poškodbe:
English: HES products are contraindicated in patients with renal impairment or renal replacement therapy (see section 4.3).
Slovenian: Zdravila, ki vsebujejo HES, so kontraindicirana pri bolnikih z okvarjenim delovanjem ledvic ali bolnikih, ki se zdravijo z nadomestnim ledvičnim zdravljenjem (glejte poglavje 4.3).
English: Data are limited in children therefore it is recommended not to use HES products in this population.
Slovenian: Pri otrocih so podatki omejeni, zato je priporočljivo, da se zdravil, ki vsebujejo HES, v tej populaciji ne uporablja.
English: Possible side effects [This section should be amended to include the below wording]
Slovenian: Možni neželeni učinki [To poglavje je treba spremeniti tako, da se vključi naslednje besedilo]
English: - congestive heart failure
Slovenian: • kongestivno srčno popuščanje
English: • have kidney impairment or receive dialysis
Slovenian: • če imate okvarjeno delovanje ledvic ali prejemate dializo
English: • problems with your heart or circulation
Slovenian: • težave s srcem ali krvnim obtokom
English: • problems with your kidneys
Slovenian: • težave z ledvicami
English: Section 4.1 Therapeutic indications [The wording of this section should be read as below] Treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Slovenian: Poglavje 4.1 Terapevtske indikacije [Besedilo tega poglavja se mora glasiti, kakor je navedeno spodaj] Zdravljenje hipovolemije zaradi akutne izgube krvi, kadar zdravljenje s kristaloidi ne zadošča (glejte poglavja 4.2., 4.3. in 4.4).
English: • have received an organ transplant
Slovenian: • pri bolnikih po presaditvi organov
English: In case of an impairment of the ability of your blood to clot, your doctor will stop giving you this medicine.
Slovenian: V primeru motnje strjevanja krvi se bo zdravnik odločil za ukinitev dajanja tega zdravila.