natgillin/translations-raw huggingface dataset:
CEPROTIN has no influence on your ability to drive or to operate machines.
CEPROTIN ne utječe na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
It is recommended that you adhere to the dose level and frequency of administration as recommended by your doctor.
Preporučuje se da se pridržavate razine doze i učestalosti primjene prema preporuci liječnika.
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.
Potrebno je imati na umu da poluvijek proteina C može biti značajno skraćen u određenim kliničkim stanjima poput akutne tromboze s purpurom fulminans i nekroze kože.
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).
Ispitivanje je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u svrhu utvrđivanja doze u indikaciji stečenog nedostatka proteina C uslijed meningokokne sepse (IMAG 112).
Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Infekcija parvovirusom B19 može biti ozbiljna za trudnice (fetalna infekcija) i za pojedince s imunodeficijencijom ili povećanom eritropoezom (npr. hemolitička anemija).
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.
Kod bolesnika s kombiniranim teškim prirođenim nedostatkom proteina C i APC rezistencijom postoje ograničeni klinički podaci koji podupiru sigurnost i djelotvornost lijeka CEPROTIN.
Heparin induced allergic reactions, which can be associated with a rapid decrease of the number of thrombocytes, may be observed (heparin induced thrombocytopenia [HIT]).
Mogu se javiti heparinom uzrokovane alergijske reakcije koje mogu biti povezane s naglim padom broja trombocita (heparinom uzrokovana trombocitopenija [HIT]).
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.
Iako se varfarinom inducirana nekroza kože može pojaviti kod bolesnika tijekom početka oralnog antikoagulantnog liječenja, pojedinci s prirođenim nedostatkom proteina C su osobito ugroženi.
This transient effect may be explained by the fact that protein C, itself a vitamin K dependent plasma protein, has a shorter half-life than most of the vitamin K dependent proteins (i.e. II, IX and X).
K ovisan plazma protein, ima kraći poluvijek od većine proteina ovisnih o vitaminu K (npr. II, IX i X).
Twelve courses of short-term prophylaxis prior to surgery or invasive therapy and 7 courses of long-term prophylaxis were included in the efficacy analyses.
U analize djelotvornosti uključeno je 12 ciklusa kratkotrajne profilakse prije kirurške operacije ili invazivnog liječenja, te 7 ciklusa dugoročne profilakse.
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.
Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom kao što su virus humane imunodeficijencije (HIV), virus hepatitisa B i virus hepatitisa C te za viruse hepatitisa
CEPROTIN proved to have no mutagenic potential in the Ames test performed.
CEPROTIN je temeljem provedenog Amesovog testa potvrdio da nema mutageni potencijal.
However, in the case of life-threatening thrombotic complications your doctor may still decide to continue treatment with CEPROTIN.
Međutim, liječnik može u slučaju po život opasnih trombotskih komplikacija odlučiti nastaviti liječenje lijekom CEPROTIN.
Powder: - The active substance is human protein C - The other ingredients are human albumin, sodium chloride and sodium citrate.2H2O.
Prašak: - Djelatna tvar je humani protein C - Drugi sastojci su humani albumin, natrijev klorid i natrijev citrat.2H2O.
Identifying HIT is complicated by the fact that these symptoms may already be present in acute phase patients with severe congenital protein C deficiency.
Utvrđivanje HIT-a komplicirano je činjenicom da ovi simptomi mogu otprije biti prisutni u akutnoj fazi bolesnika s teškim prirođenim nedostatkom proteina C.
No formal clinical study in either paediatric or neonatal population with severe congenital protein C deficiency was ever conducted.
Nikada nije provedeno službeno kliničko ispitivanje ni u pedijatrijskoj ni u novorođenačkoj populaciji s teškim prirođenim nedostatkom proteina C.
If you stop using CEPROTIN
Ako prestanete primjenjivati CEPROTIN
The solution should be discarded if particulate matter is visible.
Potrebno je odbaciti otopinu ako ima vidljivih čestica.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom kao što su HIV, HBV i HCV, te za viruse bez ovojnice kao što je virus HAV.
Do not use this medicine after the expiry date which is stated on the label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza ”Rok valjanosti”.
Human albumin, sodium chloride and sodium citrate.2H2O
Ljudski albumin, natrijev klorid i natrijev citrat.2H2O
CEPROTIN is presented as powder and solvent for solution for injection and is a white or cream coloured powder or friable solid.
CEPROTIN dolazi u obliku praška i otapala za otopinu za injekciju a prašak ili rastresita krutina su bijele ili krem boje.
If you forget to use CEPROTIN
Ako ste zaboravili primijeniti CEPROTIN
Human albumin Sodium chloride Sodium citrate.
Prašak ljudski albumin natrijev klorid natrijev citrat.
CEPROTIN has no influence on the ability to drive and use machines.
CEPROTIN ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Preporučuje se svaki put kad primite dozu lijeka CEPROTIN zabilježiti naziv i broj serije lijeka kako bi se zadržao zapis primijenjenih serija lijeka.
It is converted by thrombin/thrombomodulin-complex on the endothelial surface to activated protein C (APC).
Na endotelnoj površini pretvara se pomoću trombin/trombomodulin kompleksa u aktivirani protein C (APC).
Psychiatric disorders restlessness
Psihijatrijski poremećaji nemir
As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Kao i kod svakog intravenskog proteinskog pripravka, moguće su reakcije preosjetljivosti alergijskog tipa.
If you have kidney and/or liver disease, please inform your doctor, because he may have to adjust your treatment accordingly.
Obavijestite svog liječnika ako imate bubrežnu ili jetrenu bolest jer će možda sukladno tome trebati prilagoditi Vaše liječenje.
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”).
Ako ste prešli na trajnu profilaksu oralnim antikoagulansima, potrebno je prekinuti nadomještanje proteina C samo kad se postigne stabilna antikoagulacija (vidjeti ”Važne informacije o nekim sastojcima lijeka CEPROTIN”).
The product reconstituted with 10 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C.
Lijek pripremljen s 10 ml sterilizirane vode za injekcije sadrži približno 100 IU/ml humanog proteina C.
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).
Infekcija parvovirusom B19 može biti opasna za trudnice (fetalna infekcija) i za pojedince koji imaju oslabljen imunološki sustav ili koji imaju neku vrstu anemije (npr. anemija srpastih stanica ili hemolitička anemija).
Frequency Category by infusions
Kategorija učestalosti na temelju infuzija
It is strongly recommended that every time that CEPROTIN is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Preporučuje se kod svake primjene lijeka CEPROTIN bolesniku zabilježiti naziv i broj serije lijeka kako bi se zadržala poveznica između bolesnika i serije lijeka.
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).
Tijekom kliničkih ispitivanja lijeka CEPROTIN u 1 od 67 uključenih bolesnika prijavljene su ukupno 3 nuspojave, koje nisu bile ozbiljne (osip i svrbež, svrstani u reakcije preosjetljivosti te omaglica).
This should be taken into consideration by patients on a controlled sodium diet.
To je potrebno uzeti u obzir kod bolesnika na dijeti s ograničenim unosom natrija.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Među tim su mjerama poman odabir davatelja krvi i plazme, kako bi se isključio rizik prenošenja infekcija te ispitivanje svake doze i sakupljenih pulova plazme na znakove virusa/infekcija.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular / repeated receipt of human plasma-derived Protein C products.
Potrebno je razmisliti o odgovarajućem cijepljenju (hepatitis A, hepatitis B) za bolesnike koji redovito/opetovano primaju lijekove s proteinom C dobivenim iz ljudske plazme.
An initial dose of 60 to 80 IU/kg should be administered.
Primjenjuje se početna doza od 60 do 80 IU/kg.
One vial provides 100 IU per ml of human protein C when reconstituted as recommended.
Jedna bočica sadrži 100 IU po ml humanog proteina C kada je pripremljena prema uputama.
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived Protein C products.
Liječnik može Vam preporučiti da razmotrite cijepljenje protiv hepatitisa A i B ako redovito/opetovano primate lijekove s proteinom C dobivenim iz ljudske plazme.
CEPROTIN 1000 IU* is prepared as a powder containing nominally 1000 IU human protein C per container.
CEPROTIN 1000 IU* je pripremljen kao prašak koji nominalno sadrži 1000 IU humanog proteina C po spremniku.
CEPROTIN 500 IU* is prepared as a powder containing nominally 500 IU human protein C per container.
CEPROTIN 500 IU* je pripremljen kao prašak koji nominalno sadrži 500 IU humanog proteina C po spremniku.
In patients with HIT, symptoms such as arterial and venous thrombosis, disseminated intravascular coagulation (DIC), purpura, petechiae and gastrointestinal bleeding (melena), may occur.
Kod bolesnika s HIT-om mogu se javiti simptomi poput arterijske i venske tromboze, diseminirane intravaskularne koagulacije (DIK), purpure, petehije i gastrointestinalna krvarenja (melena).
White or cream coloured powder or friable solid.
Prašak ili rastresita krutina bijele ili krem boje.
• one transfer needle • one filter needle
• jednu iglu za prijenos • jednu filter iglu
If you change to treatment with oral anticoagulants, treatment with CEPROTIN must continue until the blood level of the oral anticoagulation is adequate and stable.
Ako prijeđete na liječenje oralnim antikoagulansima, potrebno je nastaviti liječenje proteinom C sve dok razina oralnih antikoagulansa u krvi ne bude odgovarajuća i stabilna.
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.
Liječenje lijekom CEPROTIN treba započeti pod nadzorom liječnika s iskustvom u nadomjesnoj terapiji faktorima/inhibitorima zgrušavanja pri čemu je moguće praćenje aktivnosti proteina C.
Immediate discontinuation of product use is advised.
Savjetuje se hitni prekid primjene lijeka.
Furthermore CEPROTIN is indicated for short-term prophylaxis in patients with severe congenital protein C deficiency if one or more of the following conditions are met:
Nadalje, CEPROTIN je indiciran za kratkotrajnu profilaksu kod bolesnika s teškim prirođenim nedostatkom proteina C ako je zadovoljen jedan ili više od sljedećih uvjeta:
The product reconstituted with 5 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C.
Lijek pripremljen s 5 ml sterilizirane vode za injekcije sadrži približno 100 IU/ml humanog proteina C.
In rare and exceptional cases, subcutaneous infusion of 250-350 IU/kg was able to produce therapeutic protein C plasma levels in patients with no intravenous access.
U rijetkim i iznimnim slučajevima, supkutana infuzija od 250-350 IU/kg je postigla terapijske razine proteina C u plazmi kod bolesnika bez intravenskog pristupa.
The following ADRs have been reported in the post-marketing experience:
Sljedeće su nuspojave zabilježene nakon stavljanja lijeka u promet:
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.
Učestalost i trajanje liječenja ovise o težini nedostatka proteina C, rezultatima određivanja razine proteina C u plazmi kao i o mjestu i razmjerima tromboze.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Unatoč svim tim mjerama, pri primjeni lijekova proizvedenih iz ljudske krvi ili plazme, ne može se posve isključiti mogućnost prenošenja infekcije.
Symptoms of allergy include rash, hives, breathing difficulties, low blood pressure, tightness of chest, and shock.
Simptomi alergije uključuju osip, urtikariju, probleme s disanjem, nizak krvni tlak, stezanje u prsima i šok.
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.
Daje Vam se pod nadzorom liječnika s iskustvom u nadomjesnom liječenju faktorima/inhibitorima zgrušavanja pri čemu je moguće praćenje aktivnosti proteina C.
Preferred Term
Preporučeni pojam
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).
Ako je bolesnik prešao na trajnu profilaksu oralnim antikoagulansima, potrebno je prekinuti nadomještanje proteina C samo kad se postigne stabilna antikoagulacija (vidjeti dio 4.5.).
In patients with acute thrombotic disease, both the incremental increase in protein C plasma levels as well as half-life may be considerably reduced.
Kod bolesnika s akutnom trombotskom bolešću i inkrementalni porast razine proteina C u plazmi i poluvijek mogu biti značajno smanjeni.
Do not use CEPROTIN
Nemojte primjenjivati CEPROTIN:
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:
Nadalje CEPROTIN se primjenjuje za sprečavanje tromboze kod bolesnika s teškim prirođenim nedostatkom proteina C ako su zadovoljeni jedan ili više sljedećih uvjeta
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.
CEPROTIN se primjenjuje u liječenju i sprečavanju trombotskih i krvarećih kožnih ozljeda (zvanih purpura fulminans) kod bolesnika s teškim prirođenim nedostatkom proteina C.
21 asymptomatic subjects with homozygous or double heterozygous protein C deficiency were evaluated for pharmacokinetic data.
Za farmakokinetičke podatke procijenjen je 21 asimptomatski bolesnik s homozigotnim ili dvostruko heterozigotnim nedostatkom proteina C.
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.
Budući da se rizik reakcije preosjetljivosti alergijskog tipa ne može isključiti, bolesnici moraju biti informirani o ranim znakovima reakcija preosjetljivosti uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsima, piskanje, hipotenziju i anafilaksiju.
The reconstituted solution should be used immediately.
Pripremljena otopina mora se odmah primijeniti.
• while initiating coumarin therapy
• pri uvođenju liječenja kumarinom
General disorders and administration site conditions injection site reaction
Opći poremećaji i reakcije na mjestu primjene reakcije na mjestu injekcije
For this reason, if the patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is obtained.
Stoga je, ako je bolesnik prešao na oralne antikoagulanse, potrebno nastaviti nadoknadu proteina C sve dok se postigne stabilna antikoagulacija.
The reconstituted solution should be administered immediately by intravenous injection.
Pripremljena otopina treba se odmah primijeniti intravenskom injekcijom.
Nervous System Disorders
Poremećaji živčanog sustava omaglica omaglica rijetko
How to use CEPROTIN
Kako primjenjivati CEPROTIN
After reconstitution the solution is colourless to slightly yellowish and clear to slightly opalescent and essentially free from visible particles.
Nakon pripreme otopina je bezbojna do blago žućkasta i bistra do blago opalescentna i u biti bez vidljivih čestica.
If the preparation is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Ako se pripravak koristi u bolesnika s teškim prirođenim nedostatkom proteina C, mogu se razviti protutijela koja inhibiraju protein C.
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.
Ako se lijek koristi u bolesnika s teškim prirođenim nedostatkom proteina C mogu se razviti protutijela koja mogu inhibirati protein C (inhibirajuća protitjela) i na taj način umanjiti učinak ovog lijeka.
5 ml Sterilised Water for Injections
5 ml sterilizirane vode za injekcije
How to store CEPROTIN
Kako čuvati CEPROTIN
CEPROTIN is indicated in purpura fulminans and coumarin induced skin necrosis in patients with severe congenital protein C deficiency.
CEPROTIN je indiciran kod purpure fulminans i kumarinom inducirane nekroze kože u bolesnika s teškim prirođenim nedostatkom proteina C.
10 ml Sterilised Water for Injections
10 ml sterilizirane vode za injekcije
The protein C plasma activity was measured by chromogenic assay.
Aktivnost proteina C mjerena je pomoću kromogenog testa.
Concurrent anticoagulant medication (such as heparin) may have been responsible for these bleeding episodes.
Za ove epizode krvarenja može biti odgovorna istovremena antikoagulantna terapija (poput heparina).
CEPROTIN will be administered to you by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
CEPROTIN će Vam se primijeniti intravenskom injekcijom nakon pripreme praška za otopinu za injekciju sa steriliziranom vodom za injekcije.
Sodium chloride: 44 mg/vial Sodium citrate.
Pomoćne tvari s poznatim učinkom: Natrijev klorid: 44 mg/bočica Natrijev citrat.
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).
Ako profilaktički primate protein C, mogu biti potrebne više početne doze u slučajevima povećanog rizika tromboze (kao što su infekcija, trauma ili kirurški zahvat).
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Unatoč svim tim mjerama, pri primjeni lijekova pripravljenih od ljudske krvi ili plazme, ne može se posve isključiti mogućnost prijenosa infektivnih uzročnika.
As with any intravenous product allergic type hypersensitivity reactions are possible.
Kao i kod svakog intravenskog lijeka moguće su reakcije preosjetljivosti alergijskog tipa.
APC is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. APC exerts its effect by the inactivation of the activated forms of factors V and VIII which leads to a decrease in thrombin formation.
APC postiže svoj učinak inaktivacijom aktiviranih oblika faktora V i VIII što dovodi do smanjenja formiranja trombina.
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).
Kod bolesnika u kojih se profilaktički primjenjuje protein C mogu biti potrebne više početne doze u slučajevima povećanog rizika od tromboze (kao što su infekcija, trauma ili kirurški zahvat).
Protein C is a vitamin K-dependent anticoagulant glycoprotein which is synthesised in the liver.
K ovisan antikoagulantni glikoprotein koji se sintetizira u jetri.
CEPROTIN is administered by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
CEPROTIN se primjenjuje intravenskom injekcijom nakon rekonstitucije praška za otopinu za injekciju sa steriliziranom vodom za injekcije.
You may notice any of the following side effects after administration of CEPROTIN:
Nakon primjene lijeka CEPROTIN možete primijetiti neku od sljedećih nuspojava:
Baxter AG A-1221 Vienna, Austria
Baxter AG A-1221 Beč, Austrija
System Organ Class Adverse Reaction
Klasifikacija organskih sustava
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.
Doziranje, učestalost primjene i trajanje liječenja ovise o težini nedostatka proteina C kao i o Vašem kliničkom stanju i razini proteina C u plazmi.
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.
Nadomještanje proteina C u bolesnika s nedostatkom proteina C očekuje se da će rezultirati kontroliranjem ili - ako se daje profilaktički - prevencijom trombotskih komplikacija.
After reconstitution, the solution is drawn through the sterile filter needle into a sterile disposable syringe.
Nakon pripreme, otopina se kroz sterilnu filter iglu uvuče u sterilnu štrcaljku za jednokratnu uporabu.
Reconstitute lyophilised CEPROTIN powder for solution for injection, with the supplied solvent (Sterilised Water for Injections) using the sterile transfer needle.
Pripremite liofilizirani CEPROTIN prašak za otopinu za injekciju pomoću priloženog otapala (sterilizirana voda za injekcije) koristeći sterilnu iglu za prijenos.
CEPROTIN 500 IU powder and solvent for solution for injection
CEPROTIN 500 IU prašak i otapalo za otopinu za injekciju
CEPROTIN 1000 IU powder and solvent for solution for injection
CEPROTIN 1000 IU prašak i otapalo za otopinu za injekciju
BAXTER AG Industriestrasse 67 A-1221 Vienna Austria
BAXTER AG Industriestrasse 67 A-1221 Beč Austrija
Patients with renal and/or hepatic impairment should be monitored more closely.
Bolesnike s bubrežnim i/ili jetrenim oštećenjem potrebno je pažljivije pratiti (vidjeti dio 4.4).
Solvent Sterilised Water for Injections
Otapalo sterilizirana voda za injekcije