natgillin/translations-raw huggingface dataset:
How to store Busulfan Fresenius Kabi 
Shranjevanje zdravila Busulfan Fresenius Kabi
If you get any side effects, talk to your doctor. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to restricted medical prescription. 
NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le s posebnim režimom.
In adults The recommended dose and schedule of administration is: 
Priporočeni odmerek in razpored uporabe busulfana:
Pulmonary haemorrhage 
Žilne bolezni hipertenzija
• Quantity of Busulfan Fresenius Kabi: Y (kg) x D (mg/kg) 
• Količina zdravila Busulfan Fresenius Kabi: (Y (kg) x D (mg/kg)) / (6 (mg/kg)) = A ml zdravila Busulfan Fresenius Kabi, ki ga morate redčiti Y: telesna masa bolnika v kilogramih
No age effect on busulfan clearance was evidenced from available intravenous busulfan data in patients over 60 years. 
Glede na razpoložljive podatke o intravenski uporabi busulfana pri bolnikih, starejših od 60 let, starost ne vpliva na očistek busulfana.
Similar targeting rate is achieved within the daily exposure of 3600 - 6000 µmol/L.minute following the administration of intravenous busulfan 3.2 mg/kg once daily. 
Podoben ciljni delež je bil dosežen z dnevno izpostavljenostjo od 3.600 do 6.000 µmol/l.
The terminal half life ranged from 2.26 to 2.52 h. Inter and intra patient variabilities in plasma exposure were lower than 20% and 10%, respectively. 
Odstopanja pri izpostavljenosti v plazmi so bila med bolniki manjša od 20 %, pri posameznem bolniku pa manjša od 10 %.
Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen. 
Prebavila: slabost, vnetje ustne sluznice, bruhanje, bolečina v trebuhu, driska, zaprtje, zgaga, bolečine v zadnjiku, tekočina v trebuhu.
Agitation Confusional state Hallucination 
Psihiatrične motnje agitiranost, stanje zmedenosti, halucinacije
For any information about this medicine, please contact the Marketing Authorisation Holder This leaflet was last revised in {MM/YYYY} Other sources of information 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood. 
Prebavila: vnetje sluznice požiralnika, paraliza črevesja, bruhanje krvi.
Adequate contraceptive precautions should be used when either partner is receiving Busulfan Fresenius Kabi. 
Če kateri koli od partnerjev prejema zdravilo Busulfan Fresenius Kabi, morata poskrbeti za ustrezno kontracepcijo.
There is no common metabolism pathway between busulfan and fludarabine. 
Busulfan in fludarabin nimata nobene skupne poti presnove.
- 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses, - followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16th dose of busulfan (see section 4.5). 
- sledi ciklofosfamid 60 mg/kg/dan 2 dni, vsaj 24 ur po 16. odmerku busulfana (glejte poglavje
Viral infection CMV reactivation EBV reactivation Bacterial infection 
Infekcijske in parazitske bolezni virusna okužba, reaktivacija CMV, reaktivacija EBV, bakterijska okužba invazivna glivična okužba, okužba pljuč možganski absces, celulitis, sepsa
the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent. 
Z ne-polikarbonatno brizgo, na kateri je nameščena igla: - izračunan volumen zdravila Busulfan Fresenius Kabi morate odstraniti iz viale, - vsebino brizge morate prestaviti v vrečko (ali brizgo) za intravensko uporabo, v katero ste prej že dali izračunano količino izbranega redčila.
Read this guide prior to the preparation and administration of Busulfan Fresenius Kabi. 
Pred pripravo in uporabo zdravila Busulfan Fresenius Kabi preberite to navodilo.
Mild/moderate fever was reported in 76% of patients. 
Pri 76 % bolnikov so poročali o blago/zmerno povišani telesni temperaturi.
Medicinal product subject to restricted medical prescription. 
DRUGI PODATKI Citotoksično zdravilo.
Musculoskeletal and connective tissue disorders 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija bolečina v hrbtu artralgija
Cerebral haemorrhage Encephalo-pathy 
Bolezni živčevja glavobol omotica epileptični napad encefalopatija cerebralna hemoragija
Neutropenia Thrombocytopenia Febrile neutropenia Anaemia 
Bolezni krvi in limfatičnega sistema nevtropenija trombocitopenija febrilna nevtropenija anemija
Transaminases increased Bilirubine increased Alkaline phosphatases increased 
Preiskave povišane vrednosti transaminaz povišane vrednosti bilirubina povišane vrednosti GGT povišane vrednosti alkalnih fosfataz povečanje telesne mase neobičajni zvoki pri dihanju povišane vrednosti kreatinina povišan dušik sečnine v krvi zmanjšan iztisni delež prekata
Gastro-intestinal haemorrhage Tooth hypoplasia* 
Bolezni sečil hemoragični cistitis** ledvična motnja oligurija
Tabulated lists of adverse reactions 
Pregled neželenih učinkov v preglednici
Nervous system disorders 
Priprava raztopine za infundiranje
Busulfan has not been studied in patients with hepatic impairment. 
Pri bolnikih z okvaro jeter raziskav busulfana niso opravljali.
It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with Busulfan Fresenius Kabi. 
Po zdravljenju z zdravilom Busulfan Fresenius Kabi se lahko zgodi, da ne boste mogli več zanositi (neplodnost).
Oliguria 
viala
Linearity 
Viale
Nausea Vomiting Diarrhoea Stomatitis 
Bolezni jeter, žolčnika in žolčevodov veno-okluzivna bolezen jeter zlatenica, bolezni jeter
Busulfan in combination with cyclophosphamide 
Klinična učinkovitost in varnost Busulfan v kombinaciji s ciklofosfamidom Odrasli
Stomatitis Diarrhoea Abdominal pain Nausea 
Bolezni jeter, žolčnika in žolčevodov hepatomegalija zlatenica veno-okluzivna jetrna bolezen*
This will help protect them against infectious bronchitis. 
To jim bo pomagalo pri zaščiti pred kužnim bronhitisom.
In the future if the animals are exposed to the virus the immune system will be able to respond more quickly. 
Ob ponovni izpostavitvi živali virusu v prihodnosti se bo imunski sistem tako hitreje odzval.
There are no precautions for the person, but it is recommended to wash and disinfect hands and equipment after vaccinating to avoid spread of the virus. 
Previdnostnih ukrepov za ljudi ni, vendar je priporočljivo, da si oseba po dajanju cepiva umije in razkuži roke in pripomočke, da prepreči širjenje virusa.
In one trial, after three weeks 100% of chickens had developed antibodies to the IB 4-91 virus compared with 17% for the controls. 
V enem preskušanju je po treh tednih 100 % piščancev razvilo protitelesa proti virusu IB 4-91 v primerjavi s 17 % v kontrolni skupini.
For prolonged immunity, chickens should be revaccinated every 6 weeks after the initial administration. 
Za podaljšano imunost je treba cepljenje piščancev ponavljati vsakih šest tednov.
The main measures of effectiveness included the development of antibodies to the IB 4-91 virus, the overall death rate of the chickens and the percentage of chicken rejected because of disease. 
Glavna merila učinkovitosti so bila razvoj protiteles proti virusu IB 4-91, celokupna stopnja smrtnosti piščancev in odstotek piščancev, zavrnjenih zaradi bolezni.
It is also the time allowed after administration of the medicine before eggs may be used for human consumption. 
Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko jajca uporabijo za prehrano ljudi.
The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis IB 4-91 on 9 June 1998. 
Evropska komisija je dovoljenje za promet z zdravilom Nobilis IB 4-91, veljavno po vsej Evropski uniji, izdala 9. junija 1998.
The vaccine virus may spread from vaccinated to non-vaccinated chickens, so care should be taken to separate vaccinated from non-vaccinated chickens. 
Cepni virus se lahko razširi s cepljenih na necepljene piščance, zato je treba ti skupini piščancev ločiti.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption. 
Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje ter meso uporabi za prehrano ljudi.
Avian infectious bronchitis vaccine (live attenuated) 
cepivo proti kužnemu bronhitisu perutnine (živo, atenuirano)
The Nobilis IB 4-91 vaccine has been studied in various vaccination schedules in a number of trials. 
Cepivo Nobilis IB 4-91 so proučevali v različnih shemah cepljenja v številnih preskušanjih.
Nobilis IB 4-91 can cause mild respiratory signs of disease which may last for a few days depending on the health and condition of the chickens. 
Zdravilo Nobilis IB 4-91 lahko povzroči blage oblike znakov obolenja dihalnih poti, ki lahko trajajo nekaj dni, odvisno od zdravja in splošnega stanja piščancev.
Nobilis IB 4-91 vaccine has also been compared with controls, i.e. chickens that were not vaccinated. 
Cepivo Nobilis IB 4-91 so primerjali tudi s kontrolno skupino, tj. s piščanci, ki niso bili cepljeni.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Nobilis IB 4-91 exceed the risks for the approved indication and recommended that Nobilis IB 4-91 should be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Nobilis IB 4-91 večje od z njim povezanih tveganj, kadar se uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
The vaccine was given by coarse spray to chicken of various ages. 
Cepivo je bilo dajano z razpršilnikom z večjimi kapljicami piščancem različnih starosti.
The avian infectious bronchitis virus in Nobilis IB 4-91 has been attenuated (weakened) so that it does not cause disease. 
Virus kužnega bronhitisa perutnine v cepivu Nobilis IB 4-91 je bil atenuiran (oslabljen), tako da ne povzroča bolezni.
Nobilis IB 4-91 is a vaccine. 
Zdravilo Nobilis IB 4-91 je cepivo.
The vaccine can be administered to future layers and breeders from day old onwards via intranasal/ocular route or coarse spray. 
Bodočim nesnicam in matičnim jatam se lahko cepivo daje od starosti enega dneva intranazalno/okularno ali z razpršilnikom z večjimi kapljicami.
Nobilis IB 4-91 can be given to 1-day-old chicks and older chickens by coarse spray or by intranasal (breathed in through the nose) or ocular (absorbed by the eyes) administration. 
Zdravilo Nobilis IB 4-91 se lahko enodnevnim in starejšim piščancem daje z razpršilnikom z večjimi kapljicami, intranazalno (z vdihavanjem skozi nos) ali okularno (z absorpcijo skozi oči).
Nobilis IB 4-91 is used to immunise chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91, which causes infectious bronchitis in chickens. 
Zdravilo Nobilis IB 4-91 se uporablja za imunizacijo piščancev z namenom zmanjšanja respiratornih znakov kužnega bronhitisa, ki ga povzroča različica seva IB 4-91, ki povzroča kužni bronhitis pri piščancih.
Other information about Nobilis IB 4-91: 
Druge informacije o zdravilu Nobilis IB 4-91:
The vaccine can be given to 7-day and older chickens in their drinking water. 
Piščancem, starejšim od sedem dni, se lahko cepivo daje v vodo za pitje.
When Nobilis IB 4-91 is given to chickens the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it. 
Ko piščance cepimo z zdravilom Nobilis IB 4-91, imunski sistem virus prepozna kot „tujek“ in proti njemu razvije protitelesa.
What benefit has Nobilis IB 4-91 shown during the studies? 
Kakšne koristi je zdravilo Nobilis IB 4-91 izkazalo med študijami?
Nobilis IB 4-91 is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus. 
Zdravilo Nobilis IB 4-91 je cepivo za uporabo v veterinarski medicini, ki vsebuje žive, atenuirane (oslabljene) viruse kužnega bronhitisa perutnine.
What is the risk associated with Nobilis IB 4-91? 
Kakšna tveganja so povezana z zdravilom Nobilis IB 4-91?
Why has Nobilis IB 4-91 been approved? 
Zakaj je bilo zdravilo Nobilis IB 4-91 odobreno?
The withdrawal period for Nobilis IB 4-91 for chickens is zero days. 
Karenca za cepivo Nobilis IB 4-91 pri piščancih je nič dni.
What is Nobilis IB 4-91? 
Kaj je zdravilo Nobilis IB 4-91?
How has Nobilis IB 4-91 been studied? 
Kako je bilo zdravilo Nobilis IB 4-91 raziskano?
What is Nobilis IB 4-91 used for? 
Za kaj se zdravilo Nobilis IB 4-91 uporablja?
How does Nobilis IB 4-91 work? 
Kako zdravilo Nobilis IB 4-91 deluje?
Nobilis IB 4-91 is available as a lyophilisate (freeze-dried powder) which is to be made up into a suspension. 
Na voljo je v obliki liofilizata (praška, posušenega v zamrznjenem stanju) za pripravo raztopine za injiciranje.
1 bottle + 30 syringes + 1 syringe adapter + 1 carrying case 
1 steklenica + 30 brizg + 1 adapter za brizgo + 1 priročna škatla za prenašanje
1 mg/ml 
1 mg/ml peroralna raztopina peroralna uporaba steklenica (steklo)
The standard dose of Clopidogrel Qualimed is one 75 mg tablet once a day, taken with or without 
Običajni odmerek zdravila Clopidogrel Qualimed je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
This means that Clopidogrel Qualimed is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix. 
To pomeni, da je zdravilo Clopidogrel Qualimed podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
Clopidogrel Qualimed is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). 
Zdravilo Clopidogrel Qualimed se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also 
Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Clopidogrel Qualimed can be started between a few days and 35 days after the attack; 
Zdravilo Clopidogrel Qualimed se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Qualimed to Qualimed on 23 September 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Qualimed, veljavno po vsej Evropski uniji, odobrila družbi Qualimed dne 23. septembra .
Because Clopidogrel Qualimed is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine. 
Ker je zdravilo Clopidogrel Qualimed generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Qualimed has been shown to have comparable quality and to be bioequivalent to Plavix. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Qualimed primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
Clopidogrel Qualimed is a ‘generic medicine'. 
Clopidogrel Qualimed je „generično zdravilo“.
What are the benefit and risk of Clopidogrel Qualimed? 
Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel Qualimed?
Clopidogrel Qualimed can be given to the following groups of 
Zdravilo Clopidogrel Qualimed se lahko daje naslednjim skupinam bolnikov:
Clopidogrel Qualimed can be started between seven days and six months after 
Zdravilo Clopidogrel Qualimed se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
Because Clopidogrel Qualimed is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. 
Ker je zdravilo Clopidogrel Qualimed generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
The Committee recommended that Clopidogrel Qualimed be given marketing 
Odbor je zato priporočil, da se za zdravilo Clopidogrel Qualimed odobri dovoljenje za promet.
Other information about Clopidogrel Qualimed: 
Druge informacije o zdravilu Clopidogrel Qualimed:
Clopidogrel Qualimed is a medicine that contains the active substance clopidogrel. 
Clopidogrel Qualimed je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The full EPAR for Clopidogrel Qualimed can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel Qualimed je na voljo tukaj.
The active substance in Clopidogrel Qualimed, clopidogrel, is an inhibitor of platelet aggregation. 
Zdravilna učinkovina v zdravilu Clopidogrel Qualimed, klopidogrel, je zaviralec agregacije trombocitov.
Why has Clopidogrel Qualimed been approved? 
Zakaj je bilo zdravilo Clopidogrel Qualimed odobreno?
What is Clopidogrel Qualimed used for? 
Za kaj se zdravilo Clopidogrel Qualimed uporablja?
How has Clopidogrel Qualimed been studied? 
Kako je bilo zdravilo Clopidogrel Qualimed raziskano?
Clopidogrel Qualimed clopidogrel 
Clopidogrel Qualimed klopidogrel Povzetek EPAR za javnost
Your doctor will be able to decide what is suitable for you. 
Vaš zdravnik se bo odločil, kaj je za vas najboljše.
• if you are pregnant 
• če ste noseči
Date of first authorisation: 03 August 2009 Date of latest renewal: 19 June 2014 
Datum prve odobritve: 03. avgust 2009 Datum zadnjega podaljšanja: 19. junij 2014
• allergic reactions (see above) 
• alergijske reakcije (glejte zgoraj)
• macrolide antibiotics, 
• makrolidni antibiotiki,
• Take the tablets once a day preferably in the morning with or without food. 
• Tablete vzemite enkrat na dan, najbolje zjutraj, s hrano ali brez nje.
That can lead to difficulties in concentration and memory, or in keeping your balance. 
To lahko povzroči težave s koncentracijo in spominom ali ohranjanjem ravnotežja.
To monitor the effects of Samsca your doctor will do regular blood tests. 
Za nadziranje učinkov zdravila Samsca bo zdravnik opravljal redne krvne teste.
• if you do not realise when you are thirsty 
• če ne morete zaznati, da ste žejni
• Patients who cannot perceive thirst 
• bolniki, ki ne zaznavajo žeje
• low blood pressure when standing up 
• nizek krvni tlak ob vstajanju
Consequently, the frequency of these adverse reactions is qualified as "not known". 
Zato je pogostnost teh neželenih učinkov opredeljena kot „neznana“.
This includes all medicines obtained without a prescription. 
To vključuje vsa zdravila, ki ste jih dobili brez recepta.
Therefore, patients must have access to water and be able to drink sufficient amounts of water. 
Zato morajo imeti bolniki dostop do vode in biti sposobni spiti zadostne količine vode.
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. 
Pogostnosti neželenih učinkov, o katerih so poročali med uporabo v obdobju trženja, ni mogoče določiti, saj so pridobljeni iz spontanih poročil.
The safety and efficacy of tolvaptan in children and adolescents under the age of 18 years have not yet been established. 
Varnost in učinkovitost tolvaptana pri otrocih in mladostnikih pod 18 let še nista bili dokazani.
These responses were seen in patients independent of the underlying disease. 
Te odzive so opazili pri bolnikih neodvisno od osnovne bolezni.
Appropriate replacement of water and/or electrolytes must continue until aquaresis abates. 
Ustrezno nadomeščanje vode in/ali elektrolitov se mora nadaljevati, dokler se akvareza ne ublaži.
If you forget to take your medicine you have to take the dose as soon as you remember on the same day. 
Če ste pozabili vzeti zdravilo, morate vzeti enak odmerek takoj, ko se to tega dne spomnite.
Less than 1 % of intact active substance is excreted unchanged in the urine. 
Manj kot 1 % snovi se nespremenjene izloča v urinu.
Most of the liver enzyme abnormalities were observed during the first 18 months of treatment. 
Večino nenormalnostih jetrnih encimov so opazili prvih 18 mesecev zdravljenja.
If you do not take your tablet on one day, take your normal dose on the next day. 
Če en dan ne vzamete svoje tablete, vzemite naslednji dan običajni odmerek.
It is therefore important that you have access to water and that you are able to drink sufficient amounts when you feel thirsty. 
Zato je pomembno, da imate dostop do vode in da ste sposobni spiti zadostne količine vode, ko začutite žejo.
Do not take this medicine if you are pregnant or breast-feeding. 
Tega zdravila ne jemljite, če ste noseči ali dojite.
Drinking enough water 
Pitje zadostne količine vode
• if you cannot drink enough water or if you are fluid restricted 
• če ne morete spiti dovolj vode ali so vam omejili količino tekočine
• Treatment with Samsca will be initiated in hospital. 
• Zdravljenje z zdravilom Samsca se začne v bolnici.
However, you may occasionally feel dizzy or weak or you may faint for a short period. 
Vendar pa lahko občasno povzroči občutek omotičnosti ali šibkosti, lahko pa za kratek čas tudi omedlite.
If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately. 
Če ste vzeli več tablet, kot je predpisan odmerek, spijte veliko količino vode in takoj pojdite k svojemu zdravniku ali v lokalno bolnišnico.
To achieve the desired level of serum sodium your doctor can give in some instances a lower dose of 7.5 mg. 
Za doseganje želene ravni natrija v serumu vam lahko zdravnik v nekaterih primerih da nižji odmerek 7,5 mg.
Adequate contraceptive measures must be used during use of this medicine. 
Med uporabo tega zdravila je treba uporabljati ustrezno kontracepcijo.
The efficacy and safety of tolvaptan in those with a creatinine clearance < 10 mL/min has not been evaluated and is therefore unknown. 
Učinkovitost in varnosti tolvaptana pri bolnikih z očistkom kreatinina < 10 ml/min nista bili ovrednoteni in zato nista znani.
• increased need to urinate, or to urinate more frequently 
• večja potreba po odvajanju urina ali bolj pogostemu uriniranju
The elevations gradually improved after discontinuation of tolvaptan. 
Povečanje se je po prekinitvi uporabe tolvaptana postopoma izboljšalo.
Tolvaptan has to be initiated at a dose of 15 mg once daily. 
Uporabo tolvaptana je treba začeti pri odmerku 15 mg enkrat dnevno.
• if you have a condition which increases the salt in your blood (“hypernatremia”) 
• če imate bolezen, zaradi katere se viša raven soli v vaši krvi („hipernatriemija“)
The pharmaco-dynamically predictable and most commonly reported adverse reactions are thirst, dry mouth and pollakiuria occurring in approximately 18 %, 9 % and 6 % of patients. 
Farmakodinamično predvidljivi in najbolj pogosto poročani neželeni učinki so bili žeja, suha usta in polakiurija, ki se pojavijo pri približno 18 %, 9 % in 6 % bolnikov.
Fluid and electrolyte balance 
Ravnovesje tekočine in elektrolitov
A total of 111 patients started tolvaptan treatment in an open-label, extension trial, regardless of their previous randomisation. 
Skupaj 111 bolnikov je začelo zdravljenje s tolvaptanom v odprtem podaljšanju preskušanja, ne glede na njihovo prejšnjo naključno razvrstitev v skupine.
Vasopressin is a hormone that helps prevent the loss of water from the body by reducing urine output. 
Vazopresin je hormon, ki pomaga preprečiti izgubo vode iz telesa tako, da zmanjša izločanje urina.
Samsca is not suitable for children and adolescents (under age 18). 
Zdravilo Samsca ni primerno za otroke ali mladostnike (stare manj kot 18 let).
• decrease in level of blood sugar 
• znižanje ravni sladkorja v krvi