FrancophonIA/ELRC3.0 huggingface dataset:
English: 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:
Slovenian: 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:
English: 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”).
Slovenian: 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”).
English: If you stop using CEPROTIN
Slovenian: Če ste prenehali uporabljati zdravilo CEPROTIN
English: Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Slovenian: Okužba s parvovirusom B19 je lahko resna pri nosečih ženskah (okužba ploda) in pri posameznikih z imunsko pomanjkljivostjo ali povečano eritropoezo (npr. hemolitično anemijo).
English: Protein C is a vitamin K-dependent anticoagulant glycoprotein which is synthesised in the liver.
Slovenian: Protein C je od vitamina K odvisen antikoagulantni glikoprotein, ki nastaja v jetrih.
English: What CEPROTIN looks like and contents of the pack
Slovenian: Izgled zdravila CEPROTIN in vsebina pakiranja
English: The product reconstituted with 10 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C.
Slovenian: Zdravilo, rekonstituirano z 10 ml sterilne vode za injekcije, vsebuje približno 100 i.e./ml humanega proteina C.
English: CEPROTIN is intended for intravenous administration (infusion into a vein).
Slovenian: Zdravilo CEPROTIN je namenjeno za intravensko uporabo (infundiranje v veno).
English: 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.
Slovenian: Močno priporočamo, da vsakič, ko prejmete odmerek zdravila Ceprotin, zabeležijo ime in številko serije zdravila za vodenje evidence uporabljenih serij.
English: The reports suggest that CEPROTIN is well tolerated in children and small infants.
Slovenian: Poročila kažejo, da otroci in dojenčki dobro prenašajo zdravilo CEPROTIN.
English: Symptoms of allergy include rash, hives, breathing difficulties, low blood pressure, tightness of chest, and shock.
Slovenian: Simptomi alergije vključujejo izpuščaj, koprivnico, težave z dihanjem, nizek krvni tlak, stiskanje v prsih in šok.
English: How to use CEPROTIN
Slovenian: Kako uporabljati zdravilo CEPROTIN
English: If you forget to use CEPROTIN
Slovenian: Če ste pozabili vzeti zdravilo CEPROTIN
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Bolj priporočljivo je, da peroralno antikoagulantno zdravljenje začnete z majhnim odmerkom, ki ga postopoma prilagajate, kot da uporabite standardni udarni odmerek.
English: CEPROTIN has no influence on your ability to drive or to operate machines.
Slovenian: CEPROTIN nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Psychiatric disorders restlessness
Slovenian: Psihiatrične motnje nemir
English: Powder and solvent for solution for injection One transfer needle and one filter needle
Slovenian: Vsebina: prašek in vehikel za raztopino za injiciranje ena pretočna igla in ena filtrska igla
English: 1221 Vienna
Slovenian: 1221 Dunaj
English: Do not use CEPROTIN
Slovenian: Ne uporabljajte zdravila CEPROTIN,
English: The product reconstituted with 5 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C.
Slovenian: Zdravilo, rekonstituirano s 5 ml sterilne vode za injekcije, vsebuje približno 100 i.e./ml humanega proteina C.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Slovenian: Kljub tem ukrepom pa pri dajanju zdravil, izdelanih iz človeške krvi ali plazme, ne moremo popolnoma izključiti možnosti za prenos okužbe.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Slovenian: Kot pri vseh intravenskih zdravilih, ki vsebujejo beljakovine, so možne alergijske preobčutljivostne reakcije.
English: General disorders and administration site conditions injection site reaction
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcija na mestu injiciranja
English: In patients with acute thrombotic disease, both the incremental increase in protein C plasma levels as well as half-life may be considerably reduced.
Slovenian: Pri bolnikih z akutno trombotično boleznijo sta lahko močno zmanjšana tako postopno povečevanje plazemske koncentracije proteina C kot razpolovna doba.
English: As with any intravenous product allergic type hypersensitivity reactions are possible.
Slovenian: Kot pri vsakem intravenskem zdravilu so mogoče preobčutljivostne reakcije alergijskega tipa.
English: 5 ml Sterilised Water for Injections
Slovenian: 5 ml sterilne vode za injekcije
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: As the tendency for thrombus formation decreases, the frequency may be reduced.
Slovenian: Z upadanjem nagnjenosti k nastanku krvnega strdka lahko zmanjšamo pogostnost dajanja zdravila.
English: 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.
Slovenian: 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.
English: If the preparation is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Slovenian: Če zdravilo uporabljamo pri bolnikih s hudim kongenitalnim pomanjkanjem proteina C, se lahko razvijejo protitelesa, ki zavirajo protein C.
English: 10 ml Sterilised Water for Injections
Slovenian: 10 ml sterilne vode za injekcije
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Pogostnost in trajanje zdravljenja sta odvisna od stopnje pomanjkanja proteina C, izvidov določanja koncentracije proteina C v plazmi ter mesta in obsega tromboze.
English: The protein C plasma activity was measured by chromogenic assay.
Slovenian: Plazemsko aktivnost proteina C so merili s kromogenim testom.
English: 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.
Slovenian: 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.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Slovenian: Kljub temu pa pri dajanju zdravil, izdelanih iz človeške krvi ali plazme, ne moremo popolnoma izključiti možnosti za prenos povzročiteljev infekcijskih bolezni.
English: Sodium chloride: 88 mg/vial Sodium citrate.
Slovenian: Pomožne snovi z znanim učinkom: natrijev klorid: 88 mg/vialo natrijev citrat.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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).
Slovenian: Če protein C prejemate profilaktično, so lahko potrebne višje najnižje koncentracije v okoliščinah s povečanim tveganjem za trombozo (npr. okužbe, poškodbe ali kirurški poseg).
English: 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.
Slovenian: Priporočljivo je merjenje aktivnosti proteina C z uporabo kromogenih substratov za določanje bolnikove plazemske koncentracije proteina C pred in med zdravljenjem z zdravilom CEPROTIN.
English: What CEPROTIN contains
Slovenian: Kaj vsebuje zdravilo CEPROTIN
English: For this reason, if the patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is obtained.
Slovenian: Pri prehodu na peroralne antikoagulante morate torej nadaljevati z nadomeščanjem proteina C, dokler ne dosežete stabilnega antikoagulantnega učinka.
English: 21 asymptomatic subjects with homozygous or double heterozygous protein C deficiency were evaluated for pharmacokinetic data.
Slovenian: Farmakokinetične podatke so ovrednotili pri 21 asimptomatskih bolnikih s homozigotnim ali dvojnim heterozigotnim pomanjkanjem proteina.
English: • while initiating coumarin (anticoagulant medication, blood thinner) therapy
Slovenian: • pri uvedbi kumarinske terapije (antikoagulantnega zdravila, imenovanega kumarin),
English: 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.
Slovenian: Priporočljivo je merjenje aktivnosti proteina C z uporabo kromogenih substratov za določanje plazemske koncentracije proteina C pred in med zdravljenjem z zdravilom CEPROTIN.
English: After reconstitution, the solution is drawn through the sterile filter needle into a sterile disposable syringe.
Slovenian: Po rekonstituciji raztopino posesamo skozi sterilno filtrsko iglo v razpoložljivo sterilno brizgo.
English: 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.
Slovenian: 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.
English: Sodium chloride: 44 mg/vial Sodium citrate.
Slovenian: Pomožne snovi z znanim učinkom: natrijev klorid: 44 mg/vialo natrijev citrat.
English: • while initiating coumarin therapy
Slovenian: • pri uvedbi kumarinske terapije,
English: The wide variation in individual responses implies that the effects of CEPROTIN on coagulation parameters should be checked regularly.
Slovenian: 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.
English: Talk to your doctor or pharmacist before using CEPROTIN.
Slovenian: Pred začetkom uporabe zdravila CEPROTIN se posvetujte z zdravnikom ali farmacevtom.
English: CEPROTIN 500 IU* is prepared as a powder containing nominally 500 IU human protein C per container.
Slovenian: Zdravilo CEPROTIN 500 i.e.* je pripravljeno v obliki praška, ki vsebuje nominalno 500 i.e. humanega proteina C na vialo.
English: A separate unused filter needle must be used to withdraw each vial of reconstituted CEPROTIN.
Slovenian: Za vsako vialo rekonstituiranega zdravila CEPROTIN moramo uporabiti drugo neuporabljeno filtrsko iglo.
English: Baxter AG A-1221 Vienna, Austria
Slovenian: Baxter AG A-1221 Vienna, Avstrija
English: 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.
Slovenian: 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.
English: CEPROTIN 1000 IU* is prepared as a powder containing nominally 1000 IU human protein C per container.
Slovenian: Zdravilo CEPROTIN 1000 i.e.* je pripravljeno v obliki praška, ki vsebuje nominalno 1000 i.e. humanega proteina C na vialo.
English: 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.
Slovenian: 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.
English: CEPROTIN will be administered to you by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
Slovenian: Zdravilo CEPROTIN boste prejeli z intravensko injekcijo po rekonstituciji praška za raztopino za injiciranje s sterilno vodo za injekcije.
English: Sterilised Water for Injections is used.
Slovenian: Kot vehikel je uporabljena sterilna voda za injekcije.
English: Identifying HIT is complicated by the fact that these symptoms may already be present in acute phase patients with severe congenital protein C deficiency.
Slovenian: 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.
English: The study is a randomized, double-blind, placebo-controlled dose-finding study, in the indication of acquired protein C deficiency due to meningococcal sepsis (IMAG 112).
Slovenian: Med druge izkušnje z uporabo zdravila CEPROTIN sodijo poročila o primerih in klinična študija pri skupaj 69 pediatričnih bolnikih s pridobljenim pomanjkanjem proteina C. Študija je randomizirana, dvojno slepa s placebom kontrolirana študija za ugotavljanje odmerka zdravila za indikacijo pridobljenega pomanjkanja proteina C zaradi meningokokne sepse (IMAG 112).
English: Concurrent anticoagulant medication (such as heparin) may have been responsible for these bleeding episodes.
Slovenian: Za te krvavitve je bila lahko odgovorna sočasna antikoagulantna terapija (npr. s heparinom), vendar ni mogoče popolnoma izključiti možnosti, da je uporaba zdravila CEPROTIN dodatno prispevala k tem krvavitvam.
English: No formal clinical study in either paediatric or neonatal population with severe congenital protein C deficiency was ever conducted.
Slovenian: Formalne klinične študije niso bile opravljene ne pri pediatričnih bolnikih ne pri novorojenčkih s hudim kongenitalnim pomanjkanjem proteina C, objavljenih pa je bilo več majhnih retrospektivnih in prospektivnih študij, v katerih so raziskovali druga področja klinične uporabe zdravila pri tej populaciji bolnikov.
English: System Organ Class Adverse Reaction
Slovenian: Organski sistem Neželeni učinek Prednostni izraz
English: The expiry date refers to the last day of that month.
Slovenian: Navodilo je bilo nazadnje revidirano dne .
English: It is given to you under close supervision of your doctor who is experienced in substitution therapy of coagulation factors/inhibitors and where monitoring of protein C activity is possible.
Slovenian: Prejeli ga boste pod strogim nadzorom zdravnika z izkušnjami iz nadomestne terapije s faktorji ali zaviralci koagulacije, če bo mogoče spremljanje aktivnosti proteina C. Odmerjanje zdravila bo odvisno od vašega stanja in telesne mase.
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Slovenian: Uvedeni ukrepi štejejo za učinkovite proti virusom z ovojnico, kakršni so HIV, HBV in HCV, ter proti virusu brez ovojnice HAV, lahko pa so omejene vrednosti proti virusom brez ovojnice, kakršen je parvovirus B19.
English: You may notice any of the following side effects after administration of CEPROTIN:
Slovenian: Po prejemu zdravila CEPROTIN boste morda opazili katerega od naslednjih neželenih učinkov:
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE zdravila
English: CEPROTIN 1000 IU powder and solvent for solution for injection
Slovenian: CEPROTIN 1000 i.e. prašek in vehikel za raztopino za injiciranje
English: Solvent Sterilised Water for Injections
Slovenian: Vehikel sterilna voda za injekcije
English: Reconstitute lyophilised CEPROTIN powder for solution for injection, with the supplied solvent (Sterilised Water for Injections) using the sterile transfer needle.
Slovenian: Liofilizirano zdravilo CEPROTIN prašek za raztopino za injiciranje rekonstituiramo s priloženim vehiklom (sterilna voda za injekcije) z uporabo sterilne pretočne igle.
English: Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Slovenian: BAXTER AG Industriestrasse 67 A-1221 Dunaj Avstrija
English: BAXTER AG Industriestrasse 67 A-1221 Vienna Austria
Slovenian: Baxter AG Industriestrasse 67 A-1221 Dunaj Avstrija
English: Pruritus
Slovenian: Serija
English: CEPROTIN is used in the treatment and prevention of thrombotic and haemorrhagic skin lesions (named purpura fulminans) in patients with severe congenital protein C deficiency.
Slovenian: Zdravilo CEPROTIN se uporablja pri zdravljenju in preprečevanju trombotičnih in hemoragičnih kožnih lezij (imenovanih purpura fulminans) pri bolnikih s hudim prirojenim pomanjkanjem proteina C. Poleg tega lahko zdravilo CEPROTIN uporabljamo za zdravljenje redkega zapleta pri uporabi zdravila za redčenje krvi (antikoagulanta, imenovanega kumarin), ki lahko povzroči hudo poškodbo kože (nekrozo).
English: CEPROTIN 500 IU powder and solvent for solution for injection
Slovenian: CEPROTIN 500 i.e. prašek in vehikel za raztopino za injiciranje
English: How to store CEPROTIN
Slovenian: Shranjevanje zdravila CEPROTIN
English: The solution is drawn through the sterile filter needle into a sterile disposable syringe.
Slovenian: Raztopino posesajte skozi sterilno filtrsko iglo v sterilno brizgo za enkratno uporabo.
English: CEPROTIN is administered by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
Slovenian: Zdravilo CEPROTIN dajte bolniku z intravensko injekcijo po rekonstituciji praška za raztopino za injiciranje s sterilno vodo za injekcije.
English: The following ADRs have been reported in the post-marketing experience:
Slovenian: V času trženja zdravila so bili sporočeni naslednji neželeni učinki: