natgillin/translations-raw huggingface dataset:
For general information about the dosage and how to use Ceplene and IL-2, please see Section 3, “ HOW TO USE CEPLENE”.
Za splošne podatke o odmerjanju in uporabi zdravila Ceplene in IL- 2 glejte poglavje 3 „ KAKO UPORABLJATI ZDRAVILO CEPLENE “.
26 Read the following instructions carefully.
Pozorno preberite naslednja navodila.
You will have to inject Ceplene and IL-2 twice a day by subcutaneous injection (in the layer of tissue just under the skin), according to the directions provided by your doctor.
Zdravilo Ceplene in IL- 2 si morate injicirati dvakrat na dan s subkutanim injiciranjem (v plast tkiva neposredno pod kožo) v skladu z navodili zdravnika.
Always inject IL-2 first.
Vedno najprej injicirajte IL- 2.
Your doctor will explain to you how to prepare and inject IL-2.
Zdravnik vam bo pojasnil način priprave in injiciranja IL- 2.
To prepare a dose of Ceplene you will need the following: • 1 vial of Ceplene solution (0.5 ml) • 1 sterile syringe with needle • 1 alcohol wipe
Za pripravo odmerka zdravila Ceplene boste potrebovali: • 1 vialo raztopine zdravila Ceplene (0, 5 ml) • 1 sterilno brizgo z iglo • 1 alkoholno krpico
Method 1 Take 1 vial out of the carton.
Iz škatle vzemite 1 vialo.
Remove the plastic cap from the vial, exposing the stopper with the inner rubber circle.
Pod njim sta zaporka in gumijasti zamašek.
Each mark (0.1, 0.2, 0.3, etc) represents one-tenth of a millilitre (0.1 ml).
Vsaka označba (0, 1; 0, 2; 0, 3 itd.) predstavlja eno desetino mililitra (0, 1 ml).
Figure 1
28 Slika 1
Replace the cover on the needle.
Na iglo ponovno namestite pokrov.
Take the syringe and follow the “ INSTRUCTIONS FOR INJECTION” information below.
Vzemite brizgo in sledite „ NAVODILOM ZA INJICIRANJE “ v nadaljevanju.
You will usually inject two doses of 0.5 ml in a day, unless your doctor has prescribed a lower dose for you.
Po navadi boste uporabili dva odmerka po 0, 5 ml na dan, razen če vam zdravnik predpiše manjše odmerke.
For the injection you will need the following: • 1 prepared syringe for your IL-2 injection (refer to the IL-2 package leaflet and your doctor’ s dose instructions). • 1 prepared syringe containing Ceplene. • Alcohol wipe(s). • A timer, clock or watch with a second hand. • A puncture-proof container so you can dispose of used syringes safely.
29 Za injiciranje boste potrebovali: • 1 pripravljeno brizgo za injiciranje IL- 2 (preberite navodila za uporabo IL- 2 in upoštevajte navodila zdravnika o odmerjanju) • 1 pripravljeno brizgo z zdravilom Ceplene • alkoholno( e) krpico( e) • merilnik časa, uro ali ročno uro s sekundnim kazalcem • zabojnik, zaščiten pred luknjanjem, za varno odstranitev uporabljenih brizg
Method 1.
Način 1.
For
Pripravljeni brizgi z IL- 2 in zdravilom Ceplene ter odprto alkoholno krpico položite tako, da jih lahko dosežete.
28 your safety it is very important that you are sitting where you can lean back or lie flat when you perform the injections.
Zaradi lastne varnosti se usedite na prostor, kjer se lahko tudi naslonite nazaj ali uležete po injiciranju zdravil.
Inject IL-2 as you have been instructed.
V skladu z navodili injicirajte IL- 2.
Ceplene and IL-2 must not be injected into the same region.
Zdravila Ceplene in IL- 2 ne smete injicirati na isto mesto.
For example, if you inject IL-2 in the left arm, you could inject Ceplene into the left or right thigh, the stomach, or the right arm.
Na primer, če boste IL- 2 injicirali v levo roko, potem lahko zdravilo Ceplene injicirate v levo ali desno stegno, trebuh ali desno roko.
Make sure that the area of the skin you selected is exposed.
Prepričajte se, da je izbrano mesto dovolj razkrito.
7 Hold needle either vertically (90°) or at a 45° angle to the skin and insert it under the skin as far as it will go in one quick motion.
Iglo postavite v navpičen položaj (90°) ali pod kotom 45° stopinj glede na kožo in jo z enim hitrim gibom potisnite pod kožo, kolikor globoko lahko.
Obtain new supplies and start the procedure over again, even if 3 minutes have passed after injection of IL-2.
Postopek ponovite z novo brizgo z zdravilom Ceplene, čeprav so 3 minute po injiciranju IL- 2 že potekle.
Each mark (0.1, 0.2, 0.3, etc.) represents one-tenth of a millilitre (0.1 ml).
Vsaka označba (0, 1; 0, 2; 0, 3 itd.) predstavlja eno desetino mililitra (0, 1 ml).
Push down the syringe plunger and inject one-tenth of a millilitre (0.1 ml) every minute, or more slowly if instructed to do so by your doctor.
Bat brizge potisnite navzdol in injicirajte eno desetino mililitra (0, 1 ml) vsako minuto ali še počasneje, če vam je tako naročil zdravnik.
CEPROTIN treatment should only be started by a doctor who has experience in this type of therapy and where it is possible to measure protein C activity.
Zdravljenje z zdravilom CEPROTIN sme uvesti le zdravnik, ki ima izkušnje s tovrstnim zdravljenjem, in le, kadar je možno meriti aktivnost proteina C.
CEPROTIN is given by intravenous injection (injection into a vein) at a maximum injection rate of 2 ml per minute except for children with a body weight of less than 10 kg, where the injection rate should not exceed 0.2 ml per kilogram body weight per minute.
Zdravilo CEPROTIN se daje z intravensko injekcijo (injekcija v žilo) s hitrostjo injiciranja največ 2 ml na minuto, razen pri otrocih s telesno maso, manjšo od 10 kg, pri katerih hitrost injiciranja ne sme preseči 0, 2 ml na kilogram telesne mase na minuto.
In the body, protein C controls the generation of thrombin, one of the substances (factors) involved in blood clotting.
V telesu protein C nadzoruje tvorbo trombina, t. j. ene od snovi (faktorjev), ki sodelujejo pri strjevanju krvi.
An injection of CEPROTIN gives an immediate but temporary increase in levels of protein C.
Injekcija zdravila CEPROTIN takoj, a le za kratek čas zviša raven proteina C.
Replacement of protein C in protein C deficient patients should control or prevent thrombotic (clotting) problems in these patients.
Pri bolnikih s pomanjkanjem proteina C bi naj z nadomestitvijo proteina C nadzorovali ali preprečili trombotične zaplete (zaplete pri strjevanju krvi).
CEPROTIN has been studied in a total of 79 patients, 22 of whom had a diagnosis of the more severe forms of congenital protein C deficiency.
Zdravilo CEPROTIN so preučevali pri 79 bolnikih, med katerimi jih je imelo 22 diagnosticirano hudo obliko prirojenega pomanjkanja proteina C.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged protein C levels and other indicators of coagulation (clotting) activation.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged C in drugih pokazateljev aktivacije koagulacije (strjevanja).
If CEPROTIN is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Če se zdravilo CEPROTIN uporablja pri bolnikih s hudim prirojenim pomanjkanjem proteina C, se lahko razvijejo protitelesa, ki zavirajo protein C.
For the full list of all side effects reported with CEPROTIN, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila CEPROTIN, glejte Navodilo za uporabo.
The Committee for Medicinal products for Human Use (CHMP) decided that CEPROTIN’ s benefits are greater than its risks for patients with severe congenital protein C deficiency.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila CEPROTIN za bolnike s hudim prirojenim pomanjkanjem proteina C večje od z njim povezanih tveganj.
CEPROTIN was originally authorised under ’ Exceptional Circumstances‘, because it was not possible at the time to obtain complete information on the medicine due to the low number of patients diagnosed with this disease.
Zdravilo CEPROTIN je bilo prvotno odobreno „ v izjemnih okoliščinah “, saj zaradi majhnega števila bolnikov, pri katerih so diagnosticirali to bolezen, še ni bilo mogoče zagotoviti celovitih informacij o zdravilu.
As the company had supplied the additional information requested, the ’ Exceptional Circumstances ’ ended on 28 July 2006.
Ker je podjetje posredovalo zahtevane dodatne informacije, so „ izjemne okoliščine “ prenehale veljati 28. julija 2006.
Invented name Strength Pharmaceutical form
Izmišljeno ime
Powder and solvent for Intravenous use solution for injection
prašek in vehikel za raztopino za injiciranje
Powder: vial (glass) Solvent: vial (glass)
prašek: viala (steklo) vehikel: viala (steklo)
Powder:
prašek:
500 IU Solvent:
500 i. e. vehikel:
Powder and solvent for Intravenous use
prašek in vehikel za raztopino za injiciranje
Powder: vial (glass)
prašek: viala (steklo) vehikel: viala (steklo)
1000 IU
1000 i. e. vehikel:
CEPROTIN 500 IU powder and solvent for solution for injection
CEPROTIN 500 i. e. prašek in vehikel za raztopino za injiciranje
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.
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.
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).
Sodium chloride:
Pomožne snovi: natrijev klorid:
44 mg/ vial Sodium citrate.
44 mg/ vialo natrijev citrat.
2H2O:
2H2O:
22 mg/ vial
22 mg/ vialo
For a full list of excipients see 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
* One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma.
(mednarodna enota) proteina C ustreza amidolitično merjeni aktivnosti proteina C v 1 ml normalne plazme.
White or cream coloured powder or friable solid.
Prašek in vehikel za raztopino za injiciranje Bel ali krem prašek ali krhka trdna snov.
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.
CEPROTIN is indicated in purpura fulminans and coumarin-induced skin necrosis in patients with severe congenital protein C deficiency.
Zdravilo CEPROTIN je indicirano za uporabo pri purpuri fulminans in kumarinski kožni nekrozi pri bolnikih s hudim kongenitalnim pomanjkanjem proteina C.
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: • surgery or invasive therapy is imminent • while initiating coumarin therapy • when coumarin therapy alone is not sufficient • when coumarin therapy is not feasible.
Zdravilo CEPROTIN je indicirano tudi za kratkotrajno profilakso pri bolnikih s hudim kongenitalnim pomanjkanjem proteina C, če je izpolnjen eden ali več od naslednjih pogojev: • če je nujen takojšen kirurški poseg ali invazivna terapija, • pri uvedbi kumarinske terapije, • če sama kumarinska terapija ne zadošča, • če kumarinska terapija ni izvedljiva.
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.
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 morate doseči 100% aktivnost proteina C in jo potem ohranjati nad 25% ves čas zdravljenja.
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
2 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.
The dosage should be determined on the basis of laboratory measurements of the protein C activity.
Odmerek določite na podlagi laboratorijskih meritev aktivnosti proteina C.
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.
V primeru akutnega trombotičnega dogodka te meritve opravljajte na vsakih 6 ur, dokler stanje bolnika ne bo stabilno, potem pa dvakrat na dan in vedno tik pred naslednjim injiciranjem.
Patients treated during the acute phase of their disease may display much lower increases in protein C activity.
Bolniki, zdravljeni v akutni fazi bolezni, imajo lahko precej manjše povečanje aktivnosti proteina C.
The wide variation in individual responses implies that the effects of CEPROTIN on coagulation parameters should be checked regularly.
Velik razpon individualnih odzivov kaže, da morate učinke zdravila CEPROTIN na parametre koagulacije redno preverjati.
Patients with renal and/ or hepatic impairment should be monitored more closely.
Bolnike z ledvično in/ ali jetrno okvaro je treba bolj skrbno spremljati.
(see section 4.4)
(glejte poglavje 4. 4)
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.
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). 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.
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 4.5).
V primeru prehoda na stalno profilakso s peroralnimi antikoagulanti lahko prenehate z nadomeščanjem proteina C šele, ko dosežete stabilen antikoagulantni učinek (glejte 4. 5.).
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.
Hypersensitivity to the active substance or to any of the excipients or to mouse protein or heparin, except for control of life-threatening thrombotic complications.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov, mišje beljakovine ali heparin, razen pri nadzoru smrtno nevarnih trombotičnih zapletov.
3 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.
3 V primeru šoka upoštevajte veljavne medicinske standarde za zdravljenje šoka.
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.
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
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.
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).
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.
Patients with HIT should avoid the use of heparin containing drugs in the future.
Bolniki s heparinsko trombocitopenijo se morajo v prihodnje izogibati uporabi zdravil, ki vsebujejo heparin.
However, it cannot be completely ruled out that the administration of CEPROTIN further contributed to these bleeding events.
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.
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.
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.
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.
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 4. 2.).
(See 4.2.).
4. 6 Nosečnost in dojenje
4 4.6 Pregnancy and lactation
4 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.
CEPROTIN has no influence on the ability to drive and to operate machines.
CEPROTIN nima nikakršnega vpliva na sposobnost vožnje in upravljanja s stroji.
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).
In total 21,988 administrations of CEPROTIN have been given.
Zdravilo CEPROTIN so bolnikom dali skupaj 21. 988- krat.
The distribution of the related ADRs is as follows: one report of pyrexia and one report of increased C-reactive protein in one subject, one case of urticaria in one subject, one report of pruritus, one report of rash and one report of dizziness in one subject.
Porazdelitev s tem povezanih neželenih učinkov je bila naslednja: eno poročilo o pireksiji in eno poročilo o zvišanju C reaktivnega proteina pri enem preiskovancu, en primer urtikarije pri enem preiskovancu, eno poročilo o pruritusu, eno poročilo o izpuščaju in eno poročilo o omotici pri enem preiskovancu.
With a calculated adverse experience rate (per number of administrations) of 0,005% the frequency of these ADRs can be classified as very rare.
Ker je izračunana pogostnost neželenih pojavov (na število dajanj zdravila) znašala 0, 005%, lahko te neželene učinke po pogostnosti uvrstimo med zelo redke.
In the spontaneous, postmarketing database, there have been reports of restlessness, haemothorax, hyperhydrosis, increased body temperature and increased need of catecholamines to support blood pressure (verbatim term: increased need for catecholamines) in the course of the treatment.
V podatkovni bazi, izdelani na podlagi spontanega prijavljanja neželenih učinkov v okviru postmarketinških izkušenj s tem zdravilom, so v poteku zdravljenja poročali o nemiru, hemotoraksu, hiperhidrozi, zvišani telesni temperaturi in povečani potrebi po kateholaminih za vzdrževanje krvnega tlaka (dobeseden izraz: povečana potreba po kateholaminih).
Pharmacotherapeutic group: group antithrombotic; ATC Code:
Farmakoterapevtska skupina: skupina antitrombotikov; oznaka ATC:
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).
APC is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S.
APC je serinska proteaza z močnim antikoagulantnim učinkom, še posebej v prisotnosti kofaktorja, proteina 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 učinkuje tako, da inaktivira aktivirane oblike faktorjev V in VIII, kar vodi do zmanjšanja tvorbe trombina.
The intravenous administration of CEPROTIN provides for an immediate but temporary increase in plasma levels of protein C.
Z intravensko uporabo zdravila CEPROTIN dosežemo takojšnje, a začasno povečanje plazemske koncentracije proteina C.
Replacement of protein C in protein C deficient patients is expected to control or - if given prophylactically - prevent thrombotic complications.
Pričakovati je, da bomo z nadomeščanjem proteina C pri bolnikih s pomanjkanjem proteina C nadzirali ali – pri profilaktični uporabi – preprečili trombotične zaplete.
5 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.
5 V analize učinkovitosti zdravila so vključili 12 ciklusov kratkotrajne profilakse pred kirurškim posegom ali invazivno terapijo in 7 ciklusov dolgoročne profilakse.
However, several small retrospective and prospective studies investigating other clinical application areas have been published in this population.
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.
Other experience with CEPROTIN covers case reports and a clinical study in overall 69 paediatric patients with acquired protein C deficiency.
Med druge izkušnje z uporabo zdravila CEPROTIN sodijo poročila o primerih in klinična študija pri skupaj 69 pediatričnih bolnikih s pridobljenim pomanjkanjem proteina C.
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).
Študija je randomizirana, dvojno slepa s placebom kontrolirana študija za ugotavljanje odmerka zdravila za indikacijo pridobljenega pomanjkanja proteina C zaradi meningokokne sepse (IMAG 112).