natgillin/translations-raw huggingface dataset:
Immediate discontinuation of product use is advised. 
Svetujemo takojšnjo prekinitev jemanja zdravila.
It is converted by thrombin/thrombomodulin-complex on the endothelial surface to activated protein C (APC). 
Na površini endotelija ga kompleks trombin/trombomodulin pretvori v aktiviran protein C (APC).
PHARMACEUTICAL FORM AND CONTENTS 
FarmaceVTSKA OBLIKA IN VSEBINA
One vial provides 100 IU per ml of human protein C when reconstituted as recommended. 
Ena viala vsebuje 100 i.e. na ml humanega proteina C po rekonstituciji v skladu z navodili.
Protein C plays a major role in prevention of excessive clot formation thus, prevent and/or treat intravascular thrombosis. 
Protein C ima poglavitno vlogo pri preprečevanju prekomernega nastajanja krvnih strdkov in tako preprečuje in/ali zdravi trombozo žilja.
Based on the limited clinical experience in children from reports and studies covering 83 patients, dosing guidelines for adult subjects are considered valid for neonatal and paediatric patient population (see section 5.1). 
Na podlagi omejenih kliničnih izkušenj pri otrocih ter poročil in študij, opravljenih pri 83 bolnikih, so smernice za odmerjanje zdravila pri odraslih bolnikih veljavne tudi za novorojenčke in druge pediatrične bolnike (glejte poglavje 5.1).
Difference between the recipient species and human Protein C will inevitably result in an immune response with antibody formation. 
Zaradi razlike v proteinu C med živalsko vrsto prejemnika in človekom bi neizogibno prišlo do imunskega odziva z nastajanjem protiteles.
Frequency Category by infusions 
Kategorija pogostnosti po infundiranju
CEPROTIN has no influence on the ability to drive and use machines. 
CEPROTIN nima nikakršnega vpliva na sposobnost vožnje in upravljanja s stroji.
The solution should be discarded if particulate matter is visible. 
Raztopino moramo zavreči, če so v njej vidni delci.
It should be kept in mind that the half-life of protein C may be severely shortened in certain clinical conditions such as acute thrombosis with purpura fulminans and skin necrosis. 
Ne smemo pozabiti, da je razpolovna doba proteina C lahko močno skrajšana pri določenih kliničnih stanjih, npr. pri akutni trombozi s purpuro fulminans in kožno nekrozo.
CEPROTIN is presented as powder and solvent for solution for injection and is a white or cream coloured powder or friable solid. 
Zdravilo CEPROTIN je na voljo v obliki praška in vehikla za raztopino za injiciranje in je bel ali krem prašek ali krhka trdna snov.
Protein C from human plasma purified by mouse monoclonal antibodies. 
Protein C iz človeške plazme, prečiščen z mišjimi monoklonskimi protitelesi.
This should be taken into consideration by patients on a controlled sodium diet. 
To morate upoštevati pri bolnikih na dieti z omejeno količino natrija.
The individual half-lives varied from 4.4 to 15.8 hours using a compartmental model and from 4.9 to 14.7 using the non-compartmental method. 
kompartmentalnega) modela in od 4,9 do 14,7 pri uporabi nerazdelčnega.
An initial dose of 60 to 80 IU/kg should be administered. 
Bolnik mora prejeti začetni odmerek od 60 do 80 i.e./kg.
During clinical studies with CEPROTIN, a total of 3 non-serious adverse drug reactions (ADRs) were reported in 1 of 67 patients enrolled (rash and pruritus (grouped as hypersensitivity), and dizziness). 
Med kliničnimi študijami z zdravilom CEPROTIN so pri 1 od 67 bolnikov, vključenih v te študije, poročali o skupaj 3 neresnih neželenih učinkih (ADR) (izpuščaj in pruritus (razvrščena kot preobčutljivost) ter omotica).
See section 4.4 for information on parvovirus B19 infection. 
Za informacije o okužbi s parvovirusom B19 glejte poglavje 4.4.
CEPROTIN may contain trace amounts of heparin. 
Zdravilo CEPROTIN lahko vsebuje heparin v sledovih.
In patients with combined severe congenital protein C deficiency and with APC resistance, there are limited clinical data to support the safety and efficacy of CEPROTIN. 
Pri bolnikih s kombiniranim hudim kongenitalnim pomanjkanjem proteina C in z odpornostjo na aktiviran protein C (APC) so na voljo omejeni klinični podatki v podporo varnosti in učinkovitosti zdravila CEPROTIN.
• surgery or invasive therapy is imminent 
• če je nujen takojšen kirurški poseg ali invazivna terapija,
Powder: - The active substance is human protein C - The other ingredients are human albumin, sodium chloride and sodium citrate.2H2O. 
Prašek: - Zdravilna učinkovina je humani protein C. - Pomožne snovi so humani albumin, natrijev klorid in natrijev citrat
• one transfer needle • one filter needle 
• eno pretočno iglo • eno filtrsko iglo
Heparin induced allergic reactions, which can be associated with a rapid decrease of the number of thrombocytes, may be observed (heparin induced thrombocytopenia [HIT]). 
Opisali so alergijske reakcije na heparin, ki so lahko povezane s hitrim upadom števila trombocitov (s heparinom inducirana trombocitopenija[HIT]).
After reconstitution the solution is colourless to slightly yellowish and clear to slightly opalescent and essentially free from visible particles. 
Po rekonstituciji je raztopina brezbarvna do rahlo rumenkasta in bistra do rahlo opalescentna in praktično ne vsebuje vidnih delcev.
An initial dose of 60 to 80 IU/kg for determination of recovery and half-life is advised. 
Svetujemo, da bolniku date začetni odmerek od 60 do 80 i.e./kg za določanje deleža in razpolovne dobe zdravila.
In patients with HIT, symptoms such as arterial and venous thrombosis, disseminated intravascular coagulation (DIC), purpura, petechiae and gastrointestinal bleeding (melena), may occur. 
Pri bolnikih s heparinsko trombocitopenijo se lahko pojavijo simptomi, kot so arterijska in venska tromboza, diseminirana intravaskularna koagulacija (DIC), purpura, petehije in krvavitev iz prebavil (melena).
The reconstituted solution should be used immediately. 
Rekonstituirano raztopino morate porabiti takoj.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. 
Pri izdelovanju zdravil iz človeške krvi ali plazme uvedemo določene ukrepe za preprečevanje prenosa okužb na bolnike.
Human albumin Sodium chloride Sodium citrate. 
Prašek humani albumin natrijev klorid natrijev citrat.
Furthermore CEPROTIN is used to prevent thrombosis in patients with severe congenital protein C deficiency if one or more of the following conditions are met: 
Zdravilo CEPROTIN se poleg tega uporablja tudi za preprečevanje tromboze pri bolnikih s hudim prirojenim pomanjkanjem proteina C, če je izpolnjen eden ali več od naslednjih pogojev:
If you are switched to permanent prophylaxis with oral anticoagulants, protein C replacement is to be discontinued only when stable anticoagulation is obtained (see “Important information about some of the ingredients of CEPROTIN”). 
Če bo pri vas opravljen prehod na stalno profilakso s peroralnimi antikoagulanti, lahko prenehamo z nadomeščanjem proteina C šele, ko dosežemo stabilno antikoagulacijo (glejte “Pomembne informacije o nekaterih sestavinah zdravila CEPROTIN”).
If you stop using CEPROTIN 
Če ste prenehali uporabljati zdravilo CEPROTIN
Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia). 
Okužba s parvovirusom B19 je lahko resna pri nosečih ženskah (okužba ploda) in pri posameznikih z imunsko pomanjkljivostjo ali povečano eritropoezo (npr. hemolitično anemijo).
Protein C is a vitamin K-dependent anticoagulant glycoprotein which is synthesised in the liver. 
Protein C je od vitamina K odvisen antikoagulantni glikoprotein, ki nastaja v jetrih.
What CEPROTIN looks like and contents of the pack 
Izgled zdravila CEPROTIN in vsebina pakiranja
The product reconstituted with 10 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C. 
Zdravilo, rekonstituirano z 10 ml sterilne vode za injekcije, vsebuje približno 100 i.e./ml humanega proteina C.
CEPROTIN is intended for intravenous administration (infusion into a vein). 
Zdravilo CEPROTIN je namenjeno za intravensko uporabo (infundiranje v veno).
It is strongly recommended that every time you receive a dose of CEPROTIN the name and batch number of the product are recorded in order to maintain a record of the batches used. 
Močno priporočamo, da vsakič, ko prejmete odmerek zdravila Ceprotin, zabeležijo ime in številko serije zdravila za vodenje evidence uporabljenih serij.
The reports suggest that CEPROTIN is well tolerated in children and small infants. 
Poročila kažejo, da otroci in dojenčki dobro prenašajo zdravilo CEPROTIN.
Symptoms of allergy include rash, hives, breathing difficulties, low blood pressure, tightness of chest, and shock. 
Simptomi alergije vključujejo izpuščaj, koprivnico, težave z dihanjem, nizek krvni tlak, stiskanje v prsih in šok.
How to use CEPROTIN 
Kako uporabljati zdravilo CEPROTIN
If you forget to use CEPROTIN 
Če ste pozabili vzeti zdravilo CEPROTIN
Parvovirus B 19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia). 
Okužba s parvovirusom B19 je lahko resna pri nosečih ženskah (okužba ploda) in pri posameznikih z oslabljenim imunskim sistemom ali z nekaterimi vrstami anemij (npr. bolezen srpastih celic ali hemolitično anemijo).
Furthermore, during the initiation of oral anticoagulant therapy it is advisable to start with a low dose and adjust this incrementally, rather than use a standard loading dose. 
Bolj priporočljivo je, da peroralno antikoagulantno zdravljenje začnete z majhnim odmerkom, ki ga postopoma prilagajate, kot da uporabite standardni udarni odmerek.
CEPROTIN has no influence on your ability to drive or to operate machines. 
CEPROTIN nima vpliva na sposobnost vožnje in upravljanja s stroji.
Psychiatric disorders restlessness 
Psihiatrične motnje nemir
Powder and solvent for solution for injection One transfer needle and one filter needle 
Vsebina: prašek in vehikel za raztopino za injiciranje ena pretočna igla in ena filtrska igla
1221 Vienna 
1221 Dunaj
Do not use CEPROTIN 
Ne uporabljajte zdravila CEPROTIN,
The product reconstituted with 5 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C. 
Zdravilo, rekonstituirano s 5 ml sterilne vode za injekcije, vsebuje približno 100 i.e./ml humanega proteina C.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. 
Kljub tem ukrepom pa pri dajanju zdravil, izdelanih iz človeške krvi ali plazme, ne moremo popolnoma izključiti možnosti za prenos okužbe.
Treatment with CEPROTIN should be initiated under the supervision of a physician experienced in substitution therapy with coagulation factors/inhibitors where monitoring of protein C activity is feasible. 
Zdravljenje z zdravilom CEPROTIN moramo začeti pod nadzorom zdravnika z izkušnjami iz nadomestne terapije s faktorji koagulacije ali njihovimi zaviralci, kjer je možno spremljanje aktivnosti proteina C.
Therefore, the benefit of using CEPROTIN during pregnancy or lactation must be judged against the risk for the mother and baby, and should be used only if clearly needed. 
Poleg tega niso na voljo nobene informacije o izločanju proteina C v materino mleko, zato morate korist uporabe zdravila CEPROTIN v času nosečnosti ali dojenja pretehtati glede na tveganje za mater in otroka in smete zdravilo uporabljati le, če je nujno potrebno.
As with any intravenous protein product, allergic type hypersensitivity reactions are possible. 
Kot pri vseh intravenskih zdravilih, ki vsebujejo beljakovine, so možne alergijske preobčutljivostne reakcije.
General disorders and administration site conditions injection site reaction 
Splošne težave in spremembe na mestu aplikacije reakcija na mestu injiciranja
In patients with acute thrombotic disease, both the incremental increase in protein C plasma levels as well as half-life may be considerably reduced. 
Pri bolnikih z akutno trombotično boleznijo sta lahko močno zmanjšana tako postopno povečevanje plazemske koncentracije proteina C kot razpolovna doba.
As with any intravenous product allergic type hypersensitivity reactions are possible. 
Kot pri vsakem intravenskem zdravilu so mogoče preobčutljivostne reakcije alergijskega tipa.
5 ml Sterilised Water for Injections 
5 ml sterilne vode za injekcije
The dose, administration frequency and duration of treatment depend on the severity of the protein C deficiency as well as on your clinical condition and on your plasma level of protein C. They should be adjusted accordingly on the basis of clinical effectiveness and laboratory assessment. 
Odmerek, pogostnost uporabe in trajanje zdravljenja so odvisni od stopnje pomanjkanja proteina C, vašega kliničnega stanja ter vaše plazemske koncentracije proteina C. V skladu s klinično učinkovitostjo in laboratorijskimi izvidi jih moramo ustrezno prilagajati.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. 
Uvedeni ukrepi štejejo za učinkovite proti virusom z ovojnico, kakršni so virus imunske pomanjkljivosti pri človeku (HIV), virus hepatitisa B in virus hepatitisa C, ter proti virusu hepatitisa A, ki je brez ovojnice, lahko pa so omejene vrednosti proti virusom brez ovojnice, kakršen je parvovirus B19.
As the tendency for thrombus formation decreases, the frequency may be reduced. 
Z upadanjem nagnjenosti k nastanku krvnega strdka lahko zmanjšamo pogostnost dajanja zdravila.
For the events that allergic symptoms arise which are of an acute and life-threatening nature, administration should be made within reach of life-supporting facilities. 
Zaradi možnosti pojava alergijskih simptomov, ki so akutni ali smrtno nevarni, morate zdravilo dati bolniku na mestu, kjer so na voljo sredstva za podporno terapijo.
If the preparation is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop. 
Če zdravilo uporabljamo pri bolnikih s hudim kongenitalnim pomanjkanjem proteina C, se lahko razvijejo protitelesa, ki zavirajo protein C.
10 ml Sterilised Water for Injections 
10 ml sterilne vode za injekcije
As the risk of an allergic type hypersensitivity reaction cannot be excluded, patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. 
Ker ni mogoče izključiti tveganja za pojav alergijske preobčutljivostne reakcije, morate bolniku povedati za zgodnje znake preobčutljivostne reakcije, npr. izpuščaj, generalizirano urtikarijo, stiskanje v prsih, piskanje v pljučih, hipotenzijo in anafilaksijo.
Frequency and duration of treatment depend on the severity of your protein C deficiency, on the results of determination of protein C levels in your plasma as well as on the location and extent of thrombosis. 
Pogostnost in trajanje zdravljenja sta odvisna od stopnje pomanjkanja proteina C, izvidov določanja koncentracije proteina C v plazmi ter mesta in obsega tromboze.
The protein C plasma activity was measured by chromogenic assay. 
Plazemsko aktivnost proteina C so merili s kromogenim testom.
The intravenous administration of CEPROTIN provides for an immediate but temporary increase in plasma levels of protein C. Replacement of protein C in protein C deficient patients is expected to control or - if given prophylactically - prevent thrombotic complications. 
Z intravensko uporabo zdravila CEPROTIN dosežemo takojšnje, a začasno povečanje plazemske koncentracije proteina C. Pričakovati je, da bomo z nadomeščanjem proteina C pri bolnikih s pomanjkanjem proteina C nadzirali ali - pri profilaktični uporabi - preprečili trombotične zaplete.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. 
Kljub temu pa pri dajanju zdravil, izdelanih iz človeške krvi ali plazme, ne moremo popolnoma izključiti možnosti za prenos povzročiteljev infekcijskih bolezni.
Sodium chloride: 88 mg/vial Sodium citrate. 
Pomožne snovi z znanim učinkom: natrijev klorid: 88 mg/vialo natrijev citrat.
In the case of an acute thrombotic event these should be performed every 6 hours until the patient is stabilised, thereafter twice a day and always immediately before the next injection. 
Odmerjanje je treba določiti na podlagi laboratorijskih meritev aktivnosti proteina C. V primeru akutnega trombotičnega dogodka je treba te meritve opravljati na vsakih 6 ur, dokler stanje bolnika ni stabilno, potem pa dvakrat na dan in vedno tik pred naslednjo injekcijo.
If the patient is switched to permanent prophylaxis with oral anticoagulants, protein C replacement is to be discontinued only when stable anticoagulation is obtained (see section 4.5). 
V primeru prehoda na stalno profilakso s peroralnimi antikoagulanti lahko prenehate z nadomeščanjem proteina C šele, ko dosežete stabilen antikoagulantni učinek (glejte poglavje 4.5).
Although Warfarin-induced skin necrosis can occur in any patient during the initiation of oral anticoagulant therapy, individuals with congenital protein C deficiency are particularly at risk. 
Čeprav se lahko med uvedbo peroralne antikoagulantne terapije pri kateremkoli bolniku pojavi varfarinska kožna nekroza, so še posebej ogroženi posamezniki s kongenitalnim pomanjkanjem proteina C (glejte poglavje 4.2).
In patients receiving prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention). 
Pri bolnikih, ki profilaktično prejemajo protein C, so lahko potrebne višje najnižje koncentracije v okoliščinah s povečanim tveganjem za trombozo (npr. okužbe, poškodbe ali kirurški poseg).
If you receive prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention). 
Če protein C prejemate profilaktično, so lahko potrebne višje najnižje koncentracije v okoliščinah s povečanim tveganjem za trombozo (npr. okužbe, poškodbe ali kirurški poseg).
The measurement of protein C activity using chromogenic substrates is recommended for the determination of the patient's plasma level for protein C before and during treatment with CEPROTIN. 
Priporočljivo je merjenje aktivnosti proteina C z uporabo kromogenih substratov za določanje bolnikove plazemske koncentracije proteina C pred in med zdravljenjem z zdravilom CEPROTIN.
What CEPROTIN contains 
Kaj vsebuje zdravilo CEPROTIN
For this reason, if the patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is obtained. 
Pri prehodu na peroralne antikoagulante morate torej nadaljevati z nadomeščanjem proteina C, dokler ne dosežete stabilnega antikoagulantnega učinka.
21 asymptomatic subjects with homozygous or double heterozygous protein C deficiency were evaluated for pharmacokinetic data. 
Farmakokinetične podatke so ovrednotili pri 21 asimptomatskih bolnikih s homozigotnim ali dvojnim heterozigotnim pomanjkanjem proteina.
• while initiating coumarin (anticoagulant medication, blood thinner) therapy 
• pri uvedbi kumarinske terapije (antikoagulantnega zdravila, imenovanega kumarin),
The measurement of protein C activity using chromogenic substrates is recommended for the determination of your plasma level for protein C before and during treatment with CEPROTIN. 
Priporočljivo je merjenje aktivnosti proteina C z uporabo kromogenih substratov za določanje plazemske koncentracije proteina C pred in med zdravljenjem z zdravilom CEPROTIN.
After reconstitution, the solution is drawn through the sterile filter needle into a sterile disposable syringe. 
Po rekonstituciji raztopino posesamo skozi sterilno filtrsko iglo v razpoložljivo sterilno brizgo.
If the preparation is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop that can inhibit protein C and therefore diminish the effect of the preparation. 
Če se zdravilo uporablja pri bolnikih s hudim prirojenim pomanjkanjem proteina C, lahko pride do nastanka zaviralnih protiteles proti proteinu C. Ta lahko zavirajo protein C in tako zmanjšajo učinek zdravila, vendar tega učinka še niso opažali v dosedanjih kliničnih študijah.
Sodium chloride: 44 mg/vial Sodium citrate. 
Pomožne snovi z znanim učinkom: natrijev klorid: 44 mg/vialo natrijev citrat.
• while initiating coumarin therapy 
• pri uvedbi kumarinske terapije,
The wide variation in individual responses implies that the effects of CEPROTIN on coagulation parameters should be checked regularly. 
Bolniki, zdravljeni v akutni fazi bolezni, imajo lahko precej manjše povečanje aktivnosti proteina C. Velik razpon individualnih odzivov kaže, da morate učinke zdravila CEPROTIN na parametre koagulacije redno preverjati.
Talk to your doctor or pharmacist before using CEPROTIN. 
Pred začetkom uporabe zdravila CEPROTIN se posvetujte z zdravnikom ali farmacevtom.
CEPROTIN 500 IU* is prepared as a powder containing nominally 500 IU human protein C per container. 
Zdravilo CEPROTIN 500 i.e.* je pripravljeno v obliki praška, ki vsebuje nominalno 500 i.e. humanega proteina C na vialo.
A separate unused filter needle must be used to withdraw each vial of reconstituted CEPROTIN. 
Za vsako vialo rekonstituiranega zdravila CEPROTIN moramo uporabiti drugo neuporabljeno filtrsko iglo.
Baxter AG A-1221 Vienna, Austria 
Baxter AG A-1221 Vienna, Avstrija
Patients should be informed of the early signs of hypersensitivity reactions, which may include angioedema, burning and stinging at the injection site, chills, flushing, rash, pruritus, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting and wheezing. 
Bolnike poučite o zgodnjih znakih preobčutljivostnih reakcij, med katere lahko sodijo angioedem, občutek pečenja ali zbadanja na mestu injiciranja zdravila, mrzlica, pordelost, izpuščaj, pruritus, generalizirana urtikarija, glavobol, koprivnica, hipotenzija, letargija, slabost, nemir, tahikardija, stiskanje v prsih, mravljinci, bruhanje in piskanje v pljučih.
CEPROTIN 1000 IU* is prepared as a powder containing nominally 1000 IU human protein C per container. 
Zdravilo CEPROTIN 1000 i.e.* je pripravljeno v obliki praška, ki vsebuje nominalno 1000 i.e. humanega proteina C na vialo.
You should be aware of the early signs of allergic reactions such as burning and stinging at the injection site, chills, flushing, rash, hives, breathing difficulty, nausea, headache, lethargy, low blood pressure, and tightness of the chest. 
Prepoznati morate zgodnje znake alergijskih reakcij, kot so pekoč občutek in zbadanje na mestu injiciranja, mrzlica, pordelost, izpuščaj, koprivnica, težave z dihanjem, slabost, glavobol, letargija, nizek krvni tlak in stiskanje v prsih.
CEPROTIN will be administered to you by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections. 
Zdravilo CEPROTIN boste prejeli z intravensko injekcijo po rekonstituciji praška za raztopino za injiciranje s sterilno vodo za injekcije.
Sterilised Water for Injections is used. 
Kot vehikel je uporabljena sterilna voda za injekcije.
Identifying HIT is complicated by the fact that these symptoms may already be present in acute phase patients with severe congenital protein C deficiency. 
Diagnosticiranje heparinske trombocitopenije oteži dejstvo, da so ti simptomi lahko že prisotni v akutni fazi pri bolnikih s hudim kongenitalnim pomanjkanjem proteina C. Bolniki s heparinsko trombocitopenijo se morajo v prihodnje izogibati uporabi zdravil, ki vsebujejo heparin.