natgillin/translations-raw huggingface dataset:
In the Grade 2a burn wound study an octenidine containing antiseptic wound gel and fatty gauze dressing were used as control.
Pri študijah na opeklinah stopnje 2a so kot kontrolo uporabili antiseptični gel za rane, ki vsebuje oktinidin, in namaščeno gazo za rane.
Episalvan should be used as advised by your doctor or nurse.
Če ste prenehali uporabljati zdravilo Episalvan Zdravilo Episalvan uporabljajte, kot vam je svetoval vaš zdravnik ali medicinska sestra.
If necessary, wounds (accidental wounds) should be cleaned according to standard procedure, using e.g. wound antiseptic solution, prior to application of Episalvan.
Po potrebi je treba rane (rane zaradi nezgod) pred nanosom zdravila Episalvan očistiti po standardnem postopku, tj. z uporabo antiseptične raztopine za rane.
There is no clinical experience from use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers, venous leg ulcers or wounds in patients with epidermolysis bullosa.
Kliničnih izkušenj z uporabo zdravila Episalvan, pri zdravljenju kroničnih ran, kot so npr. diabetična stopala, venske razjede na nogah ali rane pri bolnikih z bulozno epidermolizo, ni.
The effect of Episalvan on fertility has not been studied, but since the absorption of this medicine into the body is extremely low, it is not expected to have an effect on your fertility.
Študij o učinkih zdravila Episalvan na plodnost niso izvedli, ker pa je količina zdravila, ki se absorbira v telo izjemno majhna, se ne pričakuje, da zdravilo vpliva na plodnost.
Warnings and precautions Talk to your doctor or nurse before using Episalvan.
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Episalvan se posvetujte z zdravnikom.
LIST OF EXCIPIENTS Excipient: Sunflower oil.
SEZNAM POMOŽNIH SNOVI Pomožna snov: sončnično olje.
There is no experience from long-term use of Episalvan for more than 4 weeks.
Ni izkušenj z dolgotrajno uporabo zdravila Episalvan, ki presega 4 tedne.
No studies have been done on the effects of Episalvan on pregnant women, but since the absorption of this medicine into the body is extremely low, the risk to the unborn baby is negligible.
Študij o učinkih zdravila Episalvan na nosečnice niso izvedli, ker pa je količina zdravila, ki se absorbira v telo izjemno majhna, je tveganje za nerojenega otroka zanemarljivo.
If your wound shows no signs of improvement over time, talk to your doctor or nurse.
Če se stanje vaše rane ne sčasoma ne izboljša, se pogovorite s svojim zdravnikom ali medicinsko sestro.
See section 4.4 with respect to wound size and duration of treatment.
Za velikost rane in trajanje zdravljenja glejte poglavje 4.4.
How to store Episalvan 6.
Shranjevanje zdravila Episalvan 6.
This product is for single use only and once opened, the product should be used immediately.
To zdravilo je za enkratno uporabo in ga morate uporabiti nemudoma po odprtju.
In the burn wound study with 61 patients, the mean study wound area was 216 cm2; the total burn injury of these patients was larger and affected 5.8% of the total body surface area.
2; celotne opekline teh bolnikov so bile večje in so prizadele 5,8 % študijo, 216 cm celotne površine telesa.
For a subset of patients blinded photo-evaluation indicated better results for Episalvan treated wound halves compared to standard of care in pigmentation, redness and texture of the former wound areas.
Za podskupino bolnikov je slepo ocenjevanje fotografij glede pigmentacije, pordelosti in teksture območji ran pokazalo boljše rezultate pri polovicah ran, zdravljenih z zdravilom Episalvan, v primerjavi s polovicami ran, zdravljenimi s standardno oskrbo.
Driving and using machines Your ability to drive and use machines will not be affected by this medicine.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo ne vpliva na vašo sposobnost upravljanja vozil in strojev.
How to use Episalvan
Kako uporabljati zdravilo Episalvan
75223 Niefern-Öschelbronn Germany tel +49 (0) 7233 9749 - 0 fax+49 (0) 7233 9749 - 210
Faks: +49 (0) 7233 9749 - 210
The mean wound size treated with Episalvan in clinical studies in split-thickness skin graft donor site wounds was 40.7 cm² (range 8-300 cm²).
V kliničnih študijah na ranah na mestu odvzema kožnega presadka delne debeline kože je bila povprečna velikost rane, zdravljene z zdravilom Episalvan, 40,7 cm² (razpon 8300 cm²).
Application was at each wound dressing change every third to fourth day until full wound closure up to 28 days for the splitthickness skin graft trials, and every other day up to 21 days for the Grade 2a burn trial.
Pri študijah na ranah na mestu odvzema presadka delne debeline kože so nanos opravili ob vsakem previjanju rane, vsake tri do štiri dni, do popolnega zaprtja rane ali do 28 dni, pri študiji na opeklinah stopnje 2a pa vsak drug dan do 21 dni.
There is no experience of the use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers or venous leg ulcers.
Za uporabo zdravila Episalvan ni izkušenj pri zdravljenju kroničnih ran, npr. diabetičnih stopal ali venskih razjed na nogah.
• If necessary, wounds should be cleansed using a suitable antiseptic solution prior to application of Episalvan
• Po potrebi se rane pred nanosom zdravila Episalvan očisti s primerno antiseptično raztopino.
• Episalvan should be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile wound dressing.
• Zdravilo Episalvan nanesite na površino rane v debelini približno 1 mm in rano pokrijte s sterilnim povojem.
No studies have been performed to establish whether Episalvan will interact with other medicines.
Študij za ugotovitev medsebojnega delovanja zdravila Episalvan z drugimi zdravili niso izvedli.
No effects during pregnancy are anticipated, since systemic exposure to Episalvan is negligible.
Med nosečnostjo ni pričakovati nobenega vpliva, saj je sistemska izpostavljenost zanemarljiva.
1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula pendula, Betula pubescens as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin.
1 g gela vsebuje: 100 mg prečiščenega suhega ekstrakta skorje breze vrst Betula pendula in Betula pubescens ter tudi iz hibridov obeh vrst (enakovrednega 0,5-1,0 g skorje breze), kar ustreza 72-88 mg betulina.
Episalvan gel Birch bark extract
Episalvan gel ekstrakt skorje breze
No formal studies have been conducted with Episalvan in patients with renal or hepatic impairment.
Pri bolnikih z okvaro ledvic ali jeter niso izvedli nobene uradne študije z zdravilom Episalvan.
STATEMENT OF ACTIVE SUBSTANCE(S) 1g gel contains: 100 mg birch bark extract (as dry extract, refined) from Betula pendula/Betula pubescens, corresponding to 72-88 mg betulin.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 g gela vsebuje: 100 mg ekstrakta skorje breze (v obliki suhega ekstrakta, rafiniranega) iz vrst Betula pendula/Betula pubescens, kar ustreza 72-88 mg betulina.
Birch pollen allergy
Alergija na cvetni prah breze
Discard after use.
Po uporabi zavrzite.
Fresh wounds should achieve haemostasis prior to application of Episalvan.
Pred uporabo zdravila Episalvan morajo sveže rane doseči popolno hemostazo.
- If you get any side effects, talk to your doctor or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali medicinsko sestro.
Episalvan plus wound dressing was applied to half of the wound area, and the same kind of non-adhesive wound dressing alone was applied to the other half as the control in the split-thickness skin graft donor site studies.
Pri ranah na mestu odvzema presadka delne debeline kože so na polovico območja rane nanesli zdravilo Episalvan in ga povili s povojem, na drugo polovico rane pa so kontrolno namestili samo nelepljiv povoj.
Partial thickness burn wounds
Opekline delne debeline kože
The tubes are closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap.
Tube so zaprte z aluminijasto membrano, ki je ni mogoče odpreti brez vidnih poškodb, in opremljene s polipropilensko zaporko.
If you get any side effects, talk to your doctor or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali medicinsko sestro.
For cutaneous application.
Za dermalno uporabo.
Adverse reactions were administration site reactions only.
Neželeni učinki so bili omejeni zgolj na mesto nanosa.
-1.0 days (CI: -1.4, -0.6) faster wound closure with Episalvan, p<0.0001a
-1,0 dneva (CI: -1,4,0,6) hitrejše zapiranje rane z zdravilom Episalvan, p < 0,0001a a Na podlagi dvostranskega parnega t-testa.
BATCH NUMBER Lot
ŠTEVILKA SERIJE Številka serije
Infections and infestations
Infekcijske in parazitske bolezni okužbe ran
The 219 patients with split-thickness skin graft donor site wounds had a mean age of 53 years; their donor site mean wound size was 81.5 cm2.
Pri študiji povprečna starost 53 let; povprečna velikost mesta odvzema je bila 81,5 cm opeklin z 61 bolniki je bila povprečna velikost rane, pri bolnikih, ki so bili vključeni v
OUTER CARTON and TUBE
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA in TUBA
How to store Episalvan
Shranjevanje zdravila Episalvan
No data have been generated to study the effect of accidental ingestion of Episalvan.
Proučevanje učinka naključnega zaužitja zdravila Episalvan ni možno, ker ni podatkov.
This summary was last updated in September 2011.
Povzetek je bil nazadnje posodobljen septembra 2011.
The vaccine was generally well tolerated and shown to be safe.
Cepivo so živali na splošno dobro prenašale in izkazalo se je kot varno.
The vaccine is given just behind the ear.
Cepivo se daje za uho.
To maintain the immunity, a single injection of one dose should be carried out 2 - 4 weeks before each subsequent farrowing.
Za ohranjanje imunosti je potrebna ena injekcija z enojnim odmerkom 2 do 4 tedne pred vsako naslednjo prasitvijo.
The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption.
Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
The vaccine is given to sows (female pigs) only.
Cepivo se daje le svinjam (samicam).
In the study of the duration of effect, based on antibody levels, it was shown that revaccination with a single dose resulted in a clear booster response (that is, the resultant antibody levels were even higher than after the basic vaccination).
V okviru študije trajanja učinka, ki je izhajala iz ravni protiteles, je bilo dokazano, da je ponovno cepljenje z enojnim odmerkom povzročilo okrepljeni odziv (to pomeni, da so bile nato ravni protiteles celo višje kot po prvem cepljenju).
When the sow is injected, this small exposure helps the pig's immune system to recognise and attack the bacteria.
Ko svinja prejme cepivo, ta majhna izpostavitev pripomore, da njen imunski sistem prepozna in napade bakterijo.
When exposed to any of these bacteria later in life, the pig will either not become infected or have a much less serious infection.
Če bo prašič pozneje izpostavljen tem sevom, se ne bo okužil oziroma bo okužba bistveno blažja.
This bacterium is often present with Pasteurella multocida and makes the disease worse.
Ta bakterija se pogosto pojavlja skupaj z bakterijo Pasteurella multocida in otežuje bolezen.
Other side effects are reduced activity and lack of appetite in 10-20% of the pigs on the day of vaccination and/or a temporary swelling (maximum diameter: 10 cm) for up to two weeks at the injection site.
Drugi neželeni učinki sta zmanjšana aktivnost in tek pri 10 do 20 % prašičev na dan cepljenja in/ali prehodna oteklina na mestu injiciranja (največjega premera: 10 cm), ki traja do dveh tednov.
If someone is accidentally injected with this product, they should seek immediate medical advice immediately.
Ob nenamernem vbrizganju tega zdravila je treba takoj poiskati zdravniško pomoč.
Porcilis AR-T DF can cause a temporary increase in body temperature of 1.5°C, and in some pigs of up to 3°C on the day of vaccination or the following day.
Zdravilo Porcilis AR-T DF lahko povzroči prehodno povišanje telesne temperature za 1,5 °C, pri nekaterih prašičih pa tudi za do 3 °C na dan cepljenja ali naslednji dan.
The first injection should be given 6 weeks before the expected date of farrowing (giving birth to the piglets).
Prvo injekcijo je treba dati 6 tednov pred pričakovano prasitvijo (skotitvijo pujskov).
The first dose is followed by a second injection 4 weeks later.
Prvemu odmerku po 4 tednih sledi drugi.
The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis AR-T DF to Intervet International B.V. on 16 November 2000.
Evropska komisija je dovoljenje za promet z zdravilom Porcilis AR-T DF, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
The withdrawal period for Porcilis AR-T DF for pigs is zero days.
Obdobje karence za zdravilo Porcilis AR-T DF za prašiče je nič dni.
The trials showed good protection against the clinical signs of progressive atrophic rhinitis.
Študije so pokazale dobro zaščito proti kliničnim znakom progresivnega atrofičnega rinitisa.
The piglets had comparable levels of antibodies against progressive atrophic rhinitis as obtained with another approved vaccine.
Pujski so imeli primerljive ravni protiteles proti progresivnemu atrofičnemu rinitisu, kot so bile dosežene z drugim odobrenim cepivom.
The Pasteurella multocida toxin is made by a bacterium cell that has received a gene (DNA), which makes it able to produce Pasteurella multocida toxoid, a genetically modified form of toxin which has adequate immunogenic activity and which is free from the toxic properties.
Toksin Pasteurella multocida proizvaja celica bakterije, ki je prejela gen (DNK), ki ji omogoča tvorjenje toksoida Pasteurella multocida, genetsko modificirane oblike toksina, ki ima zadostno imunogenost, vendar pa nima toksičnih lastnosti.
An active ingredient of Porcilis AR-T DF, Pasteurella multocida toxin, is produced by a method known as ‘recombinant technology'.
Zdravilna učinkovina zdravila Porcilis AR-T DF, toksin Pasteurella multocida, se proizvaja z metodo, imenovano rekombinantna tehnologija.
The Package Leaflet should be taken to the doctor.
Zdravniku je treba pokazati navodilo za uporabo zdravila.
The main measure of effectiveness was the amount of antibodies to Bordetella bronchiseptica and also to Pasteurella multocida toxin.
Glavno merilo učinkovitosti je bila količina protiteles, ki se tvorijo zoper bakterijo Bordetella bronchiseptica in tudi zoper toksin bakterije Pasteurella multocida.
of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells.
toksina Pasteurella multocida in inaktiviranih celic Bordetella bronchiseptica.
Porcilis AR-T DF is a suspension for injection which contains a non-toxic recombinant derivative (see ‘How does Porcilis AR-T DF work?')
Zdravilo Porcilis AR-T DF je suspenzija za injiciranje, ki vsebuje netoksični rekombinantni derivat (glej „Kako zdravilo Porcilis AR-T DF deluje? )
What benefit has Porcilis AR-T DF shown during the studies?
Kakšne koristi je zdravilo Porcilis AR-T DF izkazalo med študijami?
Other information about Porcilis AR-T DF:
Druge informacije o zdravilu Porcilis AR-T DF:
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis AR-T DF exceed the risks for the reduction of clinical signs of progressive atrophic rhinitis in piglets, by passive oral immunisation with colostrum from dams actively immunised with the vaccine, and recommended that Porcilis AR-T DF should be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Porcilis AR-T DF za zmanjšanje kliničnih znakov progresivnega atrofičnega rinitisa pri pujskih s pasivno peroralno imunizacijo s kolostrumom samic, ki so bile aktivno imunizirane s cepivom, večje od z njim povezanih tveganj in priporočil, da se zanj odobri dovoljenje za promet.
In this study, blood was taken from piglets in each litter born from each sow, and tested for antibodies to Pasteurella multocida toxin and Bordetella bronchiseptica.
V tej študiji so pujskom iz vsakega legla vsake svinje odvzeli kri in testirali raven protiteles zoper toksin bakterije Pasteurella multocida in bakterijo Bordetella bronchiseptica.
Porcilis AR-T DF contains a non-toxic recombinant derivative (see later) of the Pasteurella multocida toxin and also inactivated Bordetella bronchiseptica bacterial cells.
Zdravilo Porcilis AR-T DF vsebuje netoksični rekombinantni derivat (glej spodaj) toksina bakterije Pasteurella multocida in tudi inaktivirane celice bakterije Bordetella bronchiseptica.
Porcilis AR-T DF is used to reduce the clinical signs of progressive atrophic rhinitis (a disease where the nose tissues become infected and die) in piglets.
Zdravilo Porcilis AR-T DF se uporablja za zmanjšanje kliničnih znakov progresivnega atrofičnega rinitisa (bolezni, pri kateri pride do okužbe nosnih tkiv, ki nato odmrejo) pri pujskih.
Progressive atrophic rhinitis is caused by toxins from the bacteria Pasteurella multocida.
Progresivni atrofični rinitis povzročajo toksini bakterije Pasteurella multocida.
Vaccine to reduce atrophic rhinitis in piglets
Cepivo za ublažitev atrofičnega rinitisa pri pujskih
What is the risk associated with Porcilis AR-T DF?
Kakšna tveganja so povezana z zdravilom Porcilis AR-T DF?
Why has Porcilis AR-T DF been approved?
Zakaj je bilo zdravilo Porcilis AR-T DF odobreno?
This immunity is passed onto the sow's piglets through her colostrum.
Imunost se prek kolostruma prenaša s svinje na pujske.
Porcilis AR-T DF has been studied in sows, where it was compared with another vaccine for progressive atrophic rhinitis.
Zdravilo Porcilis AR-T DF so preučevali pri svinjah in ga primerjali z drugim cepivom za progresivni atrofični rinitis.
Porcilis AR-T DF is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs of 18 weeks of age and older.
Zdravilo Porcilis AR-T DF se daje svinjam (samicam), starim 18 tednov ali več, v odmerku 2 ml z intramuskularno injekcijo (injekcijo v mišico).
Porcilis AR-T DF is a vaccine for use in (female) pigs to reduce atrophic rhinitis in their piglets.
Zdravilo Porcilis AR-T DF je cepivo, ki se uporablja pri svinjah (samicah) za ublažitev atrofičnega rinitisa pri njihovih mladičih.
What is Porcilis AR-T DF used for?
Za kaj se zdravilo Porcilis AR-T DF uporablja?
The length of time that Porcilis AR-T DF is effective has also been studied.
Prav tako so proučili čas trajanja učinkovitosti zdravila Porcilis AR-T DF.
What is Porcilis AR-T DF?
Kaj je zdravilo Porcilis AR-T DF?
How has Porcilis AR-T DF been studied?
Kako je bilo zdravilo Porcilis AR-T DF raziskano?
How does Porcilis AR-T DF work?
Kako zdravilo Porcilis AR-T DF deluje?
Outcome of re-examination
Izid ponovne proučitve
The applicant had requested a re-examination of the opinion.
Predlagatelj je zahteval ponoven pregled mnenja.
The summaries of the opinion of the Committee for Orphan Medicinal Products for Heparesc can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetki mnenja Odbora za zdravila sirote o zdravilu Heparesc so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The Committee thus considered that the benefits of treatment had not been sufficiently demonstrated.
Odbor je zato presodil, da koristi zdravljenja niso bile dokazane v zadostni meri.
The effects of Heparesc were first tested in experimental models before being studied in humans.
Učinki zdravila Heparesc so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to cure, diagnose or prevent a disease.
Gre za skupino zdravil, ki vsebujejo celice ali tkiva, ki so bili spremenjeni tako, da se lahko uporabljajo za zdravljenje, diagnosticiranje ali preprečevanje bolezni.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 October 2015 EMA/684158/2015 EMEA/H/C/003750
oktober 2015 EMA/684158/2015 EMEA/H/C/003750
As a result, toxic waste products build up in the blood in the form of ammonia which can lead to brain damage, convulsions (fits), coma and death.
Posledično se v krvi kopičijo strupeni odpadni produkti v obliki amonijaka, kar lahko privede do možganskih poškodb, konvulzij (napadov), kome in smrti.
After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 22 October 2015.
Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in dne 22. oktobra 2015 potrdil zavrnitev vloge za dovoljenje za promet.
The company that applied for authorisation is Cytonet GmbH & Ci KG.
Vlogo za dovoljenje za promet z zdravilom je predložila družba Cytonet GmbH & Ci KG.
Both Committees confirmed their opinion that the effectiveness of Heparesc in the treatment of these disorders had not been sufficiently demonstrated.
Oba odbora sta potrdila mnenje, da učinkovitost zdravila Heparesc pri zdravljenju teh motenj ni bila dokazana v zadostni meri.
The main measures of effectiveness were the change in the levels of 13C-labelled urea production (a test intended to show the ability to produce urea) after treatment as compared to before, and the number, length and severity of any episodes of high ammonia in the blood during the studies.
Glavni merili učinkovitosti sta bili sprememba količine nastale sečnine, označene s 13C (test, ki naj bi pokazal zmožnost tvorjenja sečnine), po zdravljenju v primerjavi s količino pred zdravljenjem ter število, dolžina in resnost epizod visokega amonijaka v krvi v času študije.
The CHMP had concerns about the design and conduct of the studies, which cast doubt on their results and whether these could have occurred by chance.
Odbor CHMP je imel pomisleke o zasnovi in izvedbi študij, ki sta vzbudili dvom o njihovih rezultatih in o tem, ali niso morda naključni.
In addition, the CHMP had concerns about the clinical relevance of the results of the tests that measured the ability to produce urea.
Poleg tega je imel odbor CHMP pomisleke o kliničnem pomenu rezultatov testov, ki so merili zmožnost tvorbe sečnine.
Heparesc was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 14 September 2007 for ornithine transcarbamylase deficiency, and 17 December 2010 for the other above conditions.
Zdravilo Heparesc je bilo dne 14. septembra 2007 določeno kot „zdravilo sirota“(zdravilo za zdravljenje redkih bolezni) za pomanjkanje ornitin-transkarbamilaze in 17. decembra 2010 za druga zgoraj navedena stanja.
Because Heparesc is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Zdravilo Heparesc je zdravilo za napredno zdravljenje, zato ga je ocenjeval Odbor za napredno zdravljenje (CAT).
Heparesc is a medicine that contains living cells from the liver of a healthy donor which have been manipulated and then frozen for long-term storage.
Heparesc je zdravilo, ki vsebuje žive celice iz jeter zdravega darovalca, ki so bile najprej spremenjene in nato zamrznjene za dolgotrajno shranjevanje.
The company presented the results of two main studies involving a total of 20 children with urea cycle disorders in which the effects of Heparesc were compared with historical results in children who had not received Heparesc treatment.
Družba je predstavila rezultate dveh glavnih študij, ki so skupaj zajele 20 otrok z motnjami cikla sečnine, pri kateri so učinke zdravila Heparesc primerjali s starimi rezultati pri otrocih, ki niso prejemali zdravljenja z zdravilom Heparesc.