natgillin/translations-raw huggingface dataset:
CIOMS frequency categories: Very Common (>=10%); Common (>=1%<10%),Uncommon (>=0.1% - <1%), Rare (>=0.01% - <0.1%), Very Rare (<0.01%).
Bolezni živčevja omotica omotica redki Kategorije pogostnosti CIOMS: zelo pogosti (> = 10 %); pogosti (> = 1 % - < 10 %), občasni (> = 0,1 % - < 1 %), redki (> = 0,01 % - < 0,1 %), zelo redki (< 0,01 %).
If such a reaction occurs, your doctor will decide on the most appropriate treatment.
Če tovrstna reakcija nastopi, bo vaš zdravnik določil najprimernejše zdravljenje za vas.
In case of shock, the current medical standards for shock treatment are to be observed.
V primeru šoka upoštevajte veljavne medicinske standarde za zdravljenje šoka.
Patients should be advised to immediately contact their physician if these symptoms occur (see section 4.4).
Bolnikom svetujte, naj se v primeru pojava teh simptomov nemudoma posvetujejo s svojim zdravnikom (glejte poglavje 4.4).
Nevertheless, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Kljub temu obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
The individual incremental recovery ranged from 0.50 to 1.76 [(IU/dL)/(IU/kg)].
Postopno naraščajoči delež pri posameznikih se je gibal od 0,50 do 1,76 [(i.e./dl)/(i.e./kg)].
Store in a refrigerator (2C - 8C).
Shranjujte v hladilniku (2 C - 8 C).
Pharmacotherapeutic group: group antithrombotic; ATC Code: B01AD12
Farmakoterapevtska skupina: skupina antitrombotikov; oznaka ATC: B01AD12
The frequency of these ADRs is not known.
Pogostnost teh neželenih učinkov ni znana.
All unused solution, empty vials and used needles and syringes must be discarded appropriately.
Vso neporabljeno raztopino, prazne viale in uporabljene igle ter brizge, moramo ustrezno zavreči.
Do not stop using CEPROTIN without consulting your doctor.
Ne prenehajte uporabljati zdravilo CEPROTIN, ne da bi se posvetovali s svojim zdravnikom.
The dose should be adjusted on the basis of laboratory assessment for each individual case.
Odmerek morate prilagoditi na podlagi laboratorijskih izvidov v vsakem posameznem primeru.
Patients with renal and/or hepatic impairment should be monitored more closely.
Bolnike z ledvično in/ali jetrno okvaro je treba bolj skrbno spremljati.
In the context of clinical experience several bleeding episodes have been observed.
V sklopu kliničnih izkušenj so opažali več krvavitev.
It is recommended that you adhere to the dose level and frequency of administration as recommended by your doctor.
Priporočamo, da upoštevate velikost odmerka in pogostnost uporabe, ki jo je priporočil vaš zdravnik.
CEPROTIN with food and drink
Zdravilo CEPROTIN skupaj s hrano in pijačo
In case you administered more CEPROTIN than recommended, please inform your doctor as soon as possible.
V primeru, da ste prejeli več zdravila CEPROTIN, kot je priporočeno, o tem čimprej obvestite svojega zdravnika.
The preparation may contain traces of heparin and/or mouse protein as a result of the manufacturing process.
Zdravilo lahko vsebuje sledove heparina in/ali mišjih beljakovin kot posledica procesa izdelave.
The patients differed significantly in age, body weight and plasma volume.
Bolniki so se bistveno razlikovali glede starosti, telesne mase in volumna plazme.
If you have kidney and/or liver disease, please inform your doctor, because he may have to adjust your treatment accordingly.
Če imate ledvično in/ali jetrno bolezen, to povejte svojemu zdravniku, ker vam bo morda moral ustrezno prilagoditi zdravljenje.
Your doctor will decide if CEPROTIN may be used during pregnancy and lactation.
Zdravnik se bo odločil, ali lahko uporabljate zdravilo CEPROTIN v času nosečnosti in dojenja.
In total 6375 administrations of CEPROTIN have been given.
Zdravilo CEPROTIN so bolnikom dali skupaj 6375-krat.
Gently rotate the vial until all powder is dissolved.
Vialo nežno obračamo, dokler se ne raztopi ves prašek.
Take special care with CEPROTIN if symptoms of allergy occur.
Bodite posebno pozorni pri prejemanju zdravila CEPROTIN, če se pojavijo simptomi alergije.
No experience in the treatment of patients with renal and/or hepatic impairment is available and therefore it is recommended that such patients be monitored more closely.
Izkušenj z zdravljenjem bolnikov z ledvično in/ali jetrno okvaro ni, zato je priporočljivo, da tovrstne bolnike bolj skrbno spremljate.
CEPROTIN proved to have no mutagenic potential in the Ames test performed.
Zdravilo CEPROTIN ni pokazalo nobenih mutagenih učinkov v opravljenem Amesovem testu.
This also applies to any unknown or emerging viruses or other types of infections.
To velja tudi za vse morebitne neznane ali porajajoče se viruse ali druge vrste okužb.
Repeated toxicity studies were not conducted because prior experience with coagulation preparations had shown them to be of limited value.
Študije toksičnosti pri ponavljajočih odmerkih niso bile opravljene, ker so predhodne izkušnje s pripravki za strjevanje krvi pokazale, da je njihova uporabnost omejena.
In case of acute thrombosis CEPROTIN may be administered to you every 6 hours.
V primeru akutne tromboze lahko prejmete zdravilo CEPROTIN na vsakih 6 ur.
3 years The reconstituted solution should be used immediately.
3 leta Rekonstituirano raztopino morate porabiti takoj.
After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg.
Po rekonstituciji je pH raztopine med 6,7 in 7,3, njena osmolalnost pa je enaka ali večja od 240 mosmol/kg.
If such symptoms occur during the administration of CEPROTIN, injection should be stopped.
Če se takšni simptomi pojavijo med prejemanjem zdravila CEPROTIN, je treba injiciranje ustaviti.
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).
Ta prehodni učinek lahko razložimo z dejstvom, da ima protein C, ki je tudi od vitamina K odvisen plazemski protein, krajšo razpolovno dobo od večine proteinov, odvisnih od vitamina K (npr. II, IX in X).
Your physician will take several blood drawings over time to determine how long protein C is remaining in your body.
Zdravnik bo med zdravljenjem odvzel več vzorcev krvi, da ugotovi, kako dolgo protein C ostane v telesu.
500 IU and 1000 IU: CEPROTIN powder comes in vials of neutral glass of either hydrolytic type I (500 IU) or hydrolytic type II (1000 IU).
500 i.e. in 1000 i.e.: CEPROTIN prašek je pakiran v viale iz nevtralnega stekla, bodisi hidrolitičnega tipa I (500 i.e.) ali hidrolitičnega tipa II (1000 i.e.).
The quantity of sodium in the maximum daily dose may exceed 200 mg.
Količina natrija v največjem dnevnem odmerku lahko preseže 200 mg.
The distribution of the related ADRs is as follows:
Porazdelitev s tem povezanih neželenih učinkov je bila naslednja:
Important information about some of the ingredients of CEPROTIN
Pomembne informacije o nekaterih sestavinah zdravila CEPROTIN
The potency (IU) is determined using a chromogenic substrate method against the World Health Organisation (WHO) International standard.
Jakost (i.e.) se določa z uporabo metode kromogenega substrata v skladu z mednarodnim standardom Svetovne zdravstvene organizacije (WHO).
Single dose toxicity testing showed that even doses of several times the recommended human dosage per kilogram body weight (10-fold) did not result in toxic effects on rodents.
Testiranje toksičnosti posameznih odmerkov je pokazalo, da celo večkratniki (10-kratnik) priporočenega odmerka za človeka na kg telesne mase nimajo toksičnih učinkov pri glodalcih.
Other medicines and CEPROTIN
Druga zdravila in zdravilo CEPROTIN
* One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma.
* Ena i.e. (mednarodna enota) proteina C ustreza amidolitično merjeni aktivnosti proteina C v 1 ml normalne plazme.
What CEPROTIN is and what it is used for
Kaj je zdravilo CEPROTIN in za kaj ga uporabljamo
Each pack also contains one transfer needle and one filter needle.
Vsako pakiranje vsebuje tudi eno pretočno iglo in eno filtrsko iglo.
If these symptoms occur, they should inform the physician.
Če se pojavijo ti simptomi, mora bolnik obvestiti zdravnika.
This medicine contains Protein C, a natural protein that is made in the liver and is present in your blood.
To zdravilo vsebuje protein C, naravni protein, ki nastaja v jetrih in je prisoten tudi v krvi.
2H2O: 44 mg/vial
2H2O: 44 mg/vialo
However, in the case of life-threatening thrombotic complications your doctor may still decide to continue treatment with CEPROTIN.
V primeru smrtno nevarnih trombotičnih zapletov se bo lahko vaš zdravnik kljub temu odločil, da nadaljuje z zdravljenjem z zdravilom CEPROTIN.
2H2O: 22 mg/vial
2H2O: 22 mg/vialo
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.
Mednje sodita tudi skrbna selekcija darovalcev krvi in plazme, da bi zagotovo izključili darovalce s tveganjem za prenos okužbe, in testiranje vsake darovane enote ter zbrane plazme na znake prisotnosti virusov ali okužb.
If you have APC resistance which is a thromboembolic risk factor present in up to 5 % of the population in Europe your doctor may need to adjust your treatment accordingly.
V primeru, da je bolnik odporen na aktiviran protein C (APC), ki je dejavnik tveganja za nastanek trombembolij, prisoten pri do 5 % populacije v Evropi, bo vaš zdravnik morda moral ustrezno prilagoditi zdravljenje.
• The following side effects were rarely observed during clinical studies (less than 1 case in 1000 administrations given to patients): itching (pruritus), rash and dizziness.
• Naslednje neželene učinke so redko opažali med kliničnimi študijami (manj kot 1 primer na 10.000 dajanj zdravila bolnikom): srbenje (pruritus), izpuščaj in omotica.
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived Protein C products.
Vaš zdravnik vam bo lahko priporočil, da se odločite za cepljenje proti hepatitisu A in B, če redno ali večkrat prejemate pripravke s proteinom C, izdelane iz človeške plazme.
• when coumarin therapy is not feasible.
• če kumarinska terapija ni izvedljiva.
- if you are allergic to Human Protein C or any of the other ingredients of this medicine (listed in section 6) including mouse protein or heparin.
- če ste alergični na (preobčutljivi za) humani protein C ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6), vključno z mišjimi beljakovinami ali heparinom.
In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists (e.g. warfarin), a transient hypercoagulable state may arise before the desired anticoagulant effect becomes apparent.
Pri bolnikih, pri katerih začenjamo zdravljenje s peroralnimi antikoagulanti iz razreda antagonistov vitamina K (npr. varfarin), lahko nastopi prehodno hiperkoagulabilno stanje, preden postane viden želeni antikoagulantni učinek.
What you need to know before you use CEPROTIN
Kaj morate vedeti, preden boste uporabili zdravilo CEPROTIN
Such symptoms may constitute an allergic reaction to any of the components, to mouse protein or heparin.
Ti simptomi lahko pomenijo alergijsko reakcijo na katero od sestavin zdravila, mišje beljakovine ali heparin.
CEPROTIN belongs to a class of medicines called antithrombotics.
Zdravilo CEPROTIN sodi v skupino zdravil, imenovanih antitrombotiki.
Dosages of the above studies, covering 83 patients, indicate that dosing guidelines for adult subjects are also valid for neonatal and paediatric patient population.
Odmerki iz zgornjih študij, v katerih so zajeli 83 bolnikov, kažejo, da smernice za odmerjanje zdravila pri odraslih veljajo tudi za novorojenčke in za druge pediatrične bolnike.
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 je serinska proteaza z močnim antikoagulantnim učinkom, še posebej v prisotnosti kofaktorja, proteina S. APC učinkuje tako, da inaktivira aktivirane oblike faktorjev V in VIII, kar vodi do zmanjšanja tvorbe trombina.
If you use more CEPROTIN than you should
Če ste uporabili večji odmerek zdravila CEPROTIN, kot bi smeli
A protein C activity of 100 % should be achieved initially and the activity should be maintained above 25 % for the duration of the treatment.
Na začetku je treba doseči 100 % aktivnost proteina C in jo potem ohranjati nad 25 % ves čas zdravljenja.
Indication was prevention and treatment of purpura fulminans and thrombotic disease, enrolling overall 14 subjects of 2 days old throughout adolescence.
Indikacija je bila preprečevanje in zdravljenje purpure fulminans in trombotične bolezni, v študiji pa je sodelovalo skupaj 14 preiskovancev, starih od 2 dni do vključno celotnega obdobja adolescence.
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.
V redkih in izjemnih primerih so s subkutano infuzijo 250-350 i.e./kg dosegli terapevtske koncentracije proteina C v plazmi pri bolnikih brez intravenskega dostopa.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Izdelovalci teh zdravil v predelavo krvi ali plazme tudi vključijo postopke, s katerimi lahko inaktivirajo ali odstranjujejo viruse.
• As with any product administered by infusion into a vein allergic reactions including severe and potentially life-threatening reactions (anaphylaxis) are possible.
• Kot pri vseh zdravilih, ki jih dajemo z infuzijo v veno, so možne alergijske reakcije, vključno s hudimi in potencialno celo življenjsko nevarnimi (anafilaktičnimi) reakcijami.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Med standardne ukrepe za preprečevanje okužb zaradi uporabe zdravil, izdelanih iz človeške krvi ali plazme, sodijo selekcija darovalcev, presejalno testiranje posameznih darovanih enot in zbrane plazme na specifične markerje okužbe ter uporaba učinkovitih proizvodnih postopkov za inaktivacijo oz. odstranjevanje virusov.
If HIT is suspected, the number of thrombocytes should be determined immediately and if necessary therapy with CEPROTIN should be stopped.
Če sumite na heparinsko trombocitopenijo, morate takoj določiti število trombocitov in po potrebi ustaviti zdravljenje z zdravilom CEPROTIN.
CEPROTIN should be administered at a maximum injection rate of 2 ml per minute except for children with a body weight of < 10 kg, where the injection rate should not exceed a rate of 0.2 ml/kg/min.
Zdravilo CEPROTIN injicirajte s hitrostjo največ 2 ml na minuto, razen pri otrocih s telesno maso < 10 kg, pri katerih hitrost injiciranja ne sme preseči 0,2 ml/kg/min.
No interactions with other medicinal products are currently known.
Doslej niso znane nobene interakcije tega zdravila z drugimi zdravili.
In children with a body weight of less than 10 kg, the injection rate should not exceed a rate of 0.2 ml/kg/min.
Pri otrocih s telesno maso manj kot 10 kg hitrost injiciranja zdravila ne sme preseči 0,2 ml/kg/min.
What CEPROTIN is and what it is used for What you need to know before you use CEPROTIN How to use CEPROTIN
Kaj je zdravilo CEPROTIN in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo CEPROTIN Kako uporabljati zdravilo CEPROTIN Možni neželeni učinki
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.
Močno priporočamo, da vsakič, ko bolniku date zdravilo CEPROTIN, zabeležite ime in številko serije zdravila, da bi se ohranila povezava med bolnikom in serijo zdravila.
Subsequently, in the initial phase of treatment, the activity of protein C is more rapidly suppressed than that of the procoagulant factors.
Zaradi tega v začetni fazi zdravljenja aktivnost proteina C zavremo hitreje kot aktivnosti prokoagulantnih faktorjev.
Protein C contained in CEPROTIN is a normal constituent of human plasma and acts like endogenous protein C. Therefore experimental studies on tumorigenic or mutagenic effects - particularly in heterologous species - are not considered necessary.
Protein C v zdravilu CEPROTIN je normalna sestavina človeške plazme in deluje kot endogeni protein C, zato menimo, da niso potrebne eksperimentalne študije tumorogenih ali mutagenih učinkov, še posebej pri heterolognih vrstah.
• when coumarin therapy alone is not sufficient
• če sama kumarinska terapija ne zadošča,
White or cream coloured powder or friable solid.
Bel ali krem prašek ali krhka trdna snov.
• In the postmarketing experience there have been reports of restlessness, excessive sweating, and pain and redness at the injection site.
• V času trženja zdravila so v poteku zdravljenja poročali o nemiru, prekomernem potenju ter bolečinah in pordelosti na mestu injiciranja.
Although CEPROTIN has been used safely in the treatment of pregnant protein C-deficient women, its safety for use in human pregnancy has not been established in controlled clinical trials.
Čeprav so zdravilo CEPROTIN že varno uporabljali pri zdravljenju nosečnic s pomanjkanjem proteina C, pa njegove varnosti v času nosečnosti pri ljudeh niso ugotavljali s kontroliranimi kliničnimi preskušanji.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse protein or heparin, except for control of life-threatening thrombotic complications.
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, mišje beljakovine ali heparin, razen pri nadzoru smrtno nevarnih trombotičnih zapletov.
CEPROTIN should be administered at a maximum injection rate of 2 ml per minute.
Zdravilo CEPROTIN smemo injicirati s hitrostjo največ 2 ml na minuto.
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.
Pri prehodu na zdravljenje s peroralnimi antikoagulanti se mora zdravljenje z zdravilom CEPROTIN nadaljevati, dokler ne bo koncentracija peroralnega antikoagulanta v krvi ustrezna in stabilna.
No symptoms of overdose with CEPROTIN have been reported.
Ni poročil o primerih prevelikega odmerjanja zdravila CEPROTIN.
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.
V analize učinkovitosti zdravila so vključili 12 ciklusov kratkotrajne profilakse pred kirurškim posegom ali invazivno terapijo in 7 ciklusov dolgoročne profilakse.
Skin and subcutaneous tissue disorders hyperhydrosis
Bolezni kože in podkožja hiperhidroza
The solvent comes in vials of neutral glass of hydrolytic type I. The product and the solvent vials are closed with butyl rubber stoppers.
Vehikel je pakiran v viale iz nevtralnega stekla hidrolitičnega tipa I. Viale z zdravilom in vehiklom so zaprte z zamaški iz butilne gume.
This also applies to unknown or emerging viruses and other pathogens.
To velja tudi za doslej še neznane ali porajajoče se viruse in druge povzročitelje bolezni.
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,