FrancophonIA/ELRC3.0 huggingface dataset:
English: • Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects have been reported following use of any medicines belonging to the sleep inducing group, including Zerene.
Slovenian: • Poročali so o reakcijah, kot so nemirnost, agitacija, razdražljivost, nenormalno mišljenje, blodnje, besnost, nočne more, depersonalizacija, halucinacije, psihoze, neprimerno vedenje, ekstrovertiranost, ki se zdi pretirana, in drugi vedenjski učinki pri uporabi katerih koli zdravil, ki spadajo med uspavala, tudi zdravila Zerene.
English: Zerene 5 mg hard capsules zaleplon
Slovenian: Zerene 5 mg trde kapsule zaleplon
English: Nervous system disorders Common:
Slovenian: Bolezni živčevja Pogosto:
English: Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Slovenian: Pomožne snovi so mikrokristalna celuloza, predgeliran škrob, silicijev dioksid, natrijev lavrilsulfat, magnezijev stearat, laktoza monohidrat, indigo karmin (E132), titanov dioksid (E171).
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171), sodium lauryl sulphate and silicon dioxide.
Slovenian: Sestavine ovojnice kapsule: želatina, titanov dioksid (E171), natrijev lavrilsulfat in silicijev dioksid.
English: For a full list of excipients, see section 6.1.
Slovenian: Pomožna snov: 54 mg laktoze monohidrata Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Always take Zerene exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Zerene natančno upoštevajte zdravnikova navodila.
English: Zerene 10 mg hard capsules zaleplon
Slovenian: Zerene 10 mg trde kapsule zaleplon
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS
Slovenian: OSNOVNI PODATKI ZA PRETISNE OMORE ALI TRAKOVE PRETISNI OMOTI S 5 MG KAPSULAMI
English: The active substance in each Zerene hard capsule is zaleplon 10 mg.
Slovenian: Kaj vsebuje zdravilo Zerene Zdravilna učinkovina v vsaki kapsuli Zerene je zaleplon 10 mg.
English: Tell your doctor if you are breast-feeding.
Slovenian: Obvestite svojega zdravnika, če dojite.
English: Excipients: Lactose monohydrate 49 mg.
Slovenian: Pomožna snov: 49 mg laktzoze monohidrata Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
Slovenian: Pri bolnikih, ki po tistem, ko vzamejo sedativ/hipnotik, niso povsem budni, so poročali še o drugih vrstah kompleksnega vedenja (npr. priprava in uživanje hrane, telefoniranje ali spolno občevanje).
English: NAME OF THE MEDICINAL PRODUCT Zerene 5 mg hard capsules zaleplon
Slovenian: IME ZDRAVILA Zerene 5 mg trde kapsule zaleplon
English: Uncommon:
Slovenian: Občasno:
English: NAME OF THE MEDICINAL PRODUCT Zerene 10 mg hard capsules
Slovenian: IME ZDRAVILA Zerene 10 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Zerene 5 mg hard capsules
Slovenian: IME ZDRAVILA Zerene 5 mg trde kapsule
English: Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate, silicon dioxide.
Slovenian: želatina, titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172) črni železov oksid (E172) natrijev lavrilsulfat silicijev dioksid
English: Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents.
Slovenian: Reakcije kot so nemir, razburjenje, razdražljivost, popustitev zavor, agresivnost, nenormalno mišljenje, zabloda, bes, nočne more, depersonalizacija, halucinacije, psihoze, neprimerno vedenje, ekstrovertiranost, ki se zdi pretirana, ter drugi vedenjski učinki se lahko pojavijo ob uporabi benzodiazepinov ali njim sorodnih učinkovin.
English: NAME OF THE MEDICINAL PRODUCT Zerene 10 mg hard capsules zaleplon
Slovenian: IME ZDRAVILA Zerene 10 mg trde kapsule zaleplon
English: nausea
Slovenian: slabost
English: General disorders and administration site conditions Uncommon:
Slovenian: Splošne težave in spremembe na mestu aplikacije Občasno:
English: Metabolism and nutrition disorders Uncommon:
Slovenian: Presnovne in prehranske motnje Občasno:
English: EU/1/99/099/004-006
Slovenian: EU/1/99/099/006 14 kapsul
English: − Keep this leaflet.
Slovenian: - Navodilo shranite.
English: EU/1/99/099/005 10 capsules EU/1/99/099/006 14 capsules
Slovenian: EU/1/99/099/005 10 kapsul
English: Renal Impairment
Slovenian: Ledvična okvara
English: EU/1/99/099/002 10 capsules EU/1/99/099/003 14 capsules
Slovenian: EU/1/99/099/003 14 kapsul
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 5 mg zaleplon
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka trda kapsula vsebuje 5 mg zaleplona.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 10 mg zaleplon
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka trda kapsula vsebuje 10 mg zaleplona.
English: EU/1/99/099/001-003
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/99/099/001-003
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da so izpolnjeni vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo spodaj opisanega zdravila:
English: • the recommended manner of placement of the material together with some comments on the importance of local haemostasis
Slovenian: • priporočenega načina namestitve materiala skupaj z nekaj opombami o pomembnosti lokalne hemostaze,
English: In addition, prior to use, surgeons intending to use Opgenra should receive a Training DVD containing animated images of an operation on a patient and including the following information: - Product description - Placement in sterile field - Wound opening (soft and hard tissues) - Reconstitution of product - Implant field preparation (haemostasis) - Administration (implantation) - Containment of implanted materials (soft tissues) - Instrumentation - Wound closure (drainage) - Follow-up measures
Slovenian: Poleg tega morajo kirurgi, ki bodo uporabljali zdravilo Opgenra, pred uporabo prejeti DVD za usposabljanje, ki vključuje slike, posnete med kirurškim posegom pri živem bolniku, in naslednje informacije: - opis izdelka, - dajanje na sterilno območje, - odpiranje rane (mehka in trda tkiva), - rekonstitucija izdelka, - priprava območja za vsadek (hemostaza), - uporaba (vsaditev), - sestava vsajenih materialov (mehka tkiva), - instrumenti, - zapiranje rane (drenaža), - ukrepi pri sledenju.
English: • the methods for soft tissue closure around the implant.
Slovenian: • metod za zapiranje mehkega tkiva okoli vsadka.
English: The National Competent Authorities shall agree the details of an education programme for surgeons with the MAH, who must implement such programme nationally to ensure that:
Slovenian: Nacionalni pristojni organi se bodo o podrobnih informacijah o izobraževalnem programu za kirurge dogovorili z imetnikom dovoljenja za promet, ki mora take programe izvajati na nacionalni ravni, da bi zagotovil:
English: • the recommended methods for reconstitution of the product prior to implantation
Slovenian: • priporočenih metod za rekonstitucijo izdelka pred vsaditvijo,
English: • the preparation of the selected paraspinal site where the intended implantation will occur
Slovenian: • priprave izbranega paraspinalnega mesta, kjer se bo opravila vsaditev,
English: - Information about: Hypersensitivity and antibody formation Embryo-foetotoxicity and the need for women with childbearing potential to use effective contraception for 2 years following implant
Slovenian: • embrio-fetotoksičnosti in potrebi pri ženskah v rodni dobi po uporabi učinkovite kontracepcije dve leti po vsaditvi,
English: Prior to use of the product, surgeons should be provided with educational material containing: - a copy of the SPC - a detailed description of:
Slovenian: Pred uporabo tega izdelka je treba kirurgom ponuditi izobraževalni material, ki vključuje: - kopijo Povzetka glavnih značilnosti zdravila; - podroben opis:
English: These descriptive texts are included in the product information.
Slovenian: To opisno besedilo je vključeno v informacije o izdelku; - informacije o:
English: • the risks of ectopic bone formation interaction with bone void fillers that the product should only be used once - details of the post marketing surveillance studies including information on how to enroll patients
Slovenian: podrobne informacije o študijah postmarketinškega nadzora, vključno z informacijami o tem, kako so se vključevali bolniki.
English: This summary was last updated in 10-2007.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2007.
English: The marketing authorisation was renewed on 26 February 2004.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano 26. februarja 2004.
English: Medicinal product no longer authorise©EMEA 2007
Slovenian: Zdravilo nima veā dovoljenja za prome©EMEA 2007
English: The first infusion is given in the 24 hours before transplantation.
Slovenian: Prvo infuzijo damo v 24 urah pred presaditvijo.
English: These antibodies can develop following blood transfusion, pregnancy or previous organ transplantation.
Slovenian: Ta protitelesa se lahko tvorijo po transfuzijah krvi, nosečnosti ali predhodni presaditvi organa.
English: It is used in patients who do not have high levels of antibodies against ‘foreign' cells from other people.
Slovenian: Uporablja se pri bolnikih, ki nimajo visokih ravni protiteles proti „tujim“ celicam drugih ljudi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zenapax to Roche Registration Limited on 26 February 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zenapax, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 26. februarja 1999.
English: The recommended dose for adults and children is 1 mg per kilogram body weight, diluted in 50 ml sterile saline solution and given over 15 minutes.
Slovenian: Priporočeni odmerek za odrasle in otroke je 1 mg na kilogram telesne mase, ki se razredči v 50 ml sterilne fiziološke raztopine ter daje v obdobju 15 minut.
English: It contains the active substance daclizumab (5 mg/ml).
Slovenian: Vsebuje zdravilno učinkovino daclizumab (5 mg/ml).
English: If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Other information about Zenapax:
Slovenian: Druge informacije o zdravilu Zenapax:
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Slovenian: Monoklonsko protitelo je protitelo (vrsta beljakovine), ki prepoznava in se veže na specifično strukturo (imenovano antigen), ki se nahaja na določenih celicah v telesu.
English: The most common side effects (seen in more than 1 patient in 10) were insomnia (difficulty sleeping), tremor (shaking), headache, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, diarrhoea, vomiting, nausea (feeling sick), dyspepsia (heartburn), musculoskeletal pain (pain in the muscles and joints), oedema (swelling), impaired healing and post-traumatic pain (pain after surgery).
Slovenian: Najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) so bili nespečnost (težave pri spanju), tremor (tresenje), glavobol, hipertenzija (visok krvni tlak), dispneja (oteženo dihanje), zaprtje, driska, bruhanje, slabost, dispepsija (zgaga), mišično-skeletne bolečine (bolečine v mišicah in sklepih), edem (otekanje), slabše celjenje in posttravmatske bolečine (bolečine po kirurškem posegu).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ZENAPAX EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) ZENAPAX Povzetek EPAR za javnost
English: The main measure of effectiveness was the proportion of patients who experienced rejection of the transplanted kidney in the first six months after the transplant.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih je prišlo do zavrnitve presajene ledvice v prvih šestih mesecih po presaditvi.
English: The subsequent doses should be given every 14 days for a total of five doses.
Slovenian: Nadaljnji odmerki se dajejo vsakih 14 dni.
English: Zenapax should only be prescribed and given by doctors who have experience in the use of immunosuppressive treatment following organ transplant.
Slovenian: Zdravilo Zenapax smejo predpisati in uporabljati le zdravniki, ki imajo izkušnje z imunosupresivnim zdravljenjem po presaditvi organa.
English: Zenapax has been studied in two main studies involving a total of 535 adults undergoing kidney transplant.
Slovenian: Zdravilo Zenapax so preučili v dveh glavnih študijah, v kateri je bilo vključenih 535 odraslih bolnikov s presaditvijo ledvice.
English: A further study looked at rejection rates in 60 children aged between five and 18 years who were undergoing a kidney transplant.
Slovenian: V dodatni študiji so ugotavljali stopnje zavrnitve pri 60 otrocih, starih od 5 do 18 let, katerim so presadili ledvico.
English: Zenapax should not be used in people who may be hypersensitive (allergic) to daclizumab or any of the other ingredients.
Slovenian: Zdravila Zenapax se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) daclizumab ali katerokoli drugo sestavino zdravila.
English: The Committee recommended that Zenapax be given marketing authorisation.
Slovenian: Odbor je priporočil odobritev dovoljenja za promet z zdravilom Zenapax.
English: What benefit has Zenapax shown during the studies?
Slovenian: Kakšne koristi je zdravilo Zenapax izkazalo med študijami?
English: By binding to and blocking the receptor, daclizumab prevents interleukin-2 activating the T-lymphocytes, reducing the chance that the transplanted kidney will be rejected.
Slovenian: Ko se daclizumab veže na receptor in ga blokira, prepreči, da bi interlevkin-2 aktiviral limfocite T, s tem pa zmanjša možnost zavrnitve presajene ledvice.
English: In this study, Zenapax was added to the children's existing immunosuppressive medicines.
Slovenian: V tej študiji so zdravilo Zenapax dodajali obstoječim imunosupresivnim zdravilom.
English: It is used together with other immunosuppressive (anti-rejection) medicines including ciclosporin and corticosteroids.
Slovenian: Uporablja se skupaj z drugimi imunosupresivnimi učinkovinami (učinkovinami za preprečevanje zavrnitve), vključno s ciklosporinom in kortikosteroidi.
English: azathioprine.
Slovenian: prednizon in azatioprin.
English: The active substance in Zenapax, daclizumab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina zdravila Zenapax je daclizumab, ki je monoklonsko protitelo.
English: In the first study, the patients were receiving ciclosporin and prednisone (a corticosteroid), and in the second study, they were receiving ciclosporin, prednisone and
Slovenian: V prvi študiji so bolniki prejemali ciklosporin in prednizon (kortikosteroid), v drugi študiji pa so prejemali ciklosporin,
English: In the study of children, five (8%) experienced rejection in the first six months after the transplant.
Slovenian: V študiji pri otrocih je prišlo do zavrnitve v prvih šestih mesecih po presaditvi pri 5 (8 %) otrocih.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Zenapax's benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation, used concomitantly with an immunosuppressive regimen, including ciclosporin and corticosteroids in patients who are not highly immunised.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristni učinki zdravila Zenapax pri preprečevanju akutne zavrnitve organa pri de novo alogeni ledvični transplantaciji pri bolnikih, ki niso visoko senzibilizirani, ob sočasnem režimu imunosupresivnih zdravil, vključno s ciklosporinom in kortikosteroidi, večji od z njim povezanih tveganj.
English: What is the risk associated with Zenapax?
Slovenian: Kakšna tveganja so povezana z zdravilom Zenapax?
English: For the full list of side effects reported with Zenapax, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zenapax, glejte Navodilo za uporabo.
English: Zenapax is a concentrate to be made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Zenapax je koncentrat, ki se pripravi v raztopino za infundiranje (dajanje tekočine v veno).
English: In the first study, 28 (22%) of the 126 adults adding Zenapax to ciclosporin and prednisone experienced rejection, compared with 47 (35%) of the 134 adding placebo.
Slovenian: V prvi študiji je do zavrnitve prišlo pri 28 (22 %) od 126 odraslih bolnikov, pri katerih so zdravilo Zenapax dodajali ciklosporinu in prednizonu, in pri 47 (35 %) od 134 odraslih bolnikov, pri katerih so ciklosporinu in prednizonu dodajali placebo.
English: Zenapax is used to prevent the body from rejecting a kidney soon after a transplant.
Slovenian: Zdravilo Zenapax se uporablja za preprečevanje zavrnitve ledvice po presaditvi.
English: In the second study, 39 (28%) of the 141 adults adding Zenapax to ciclosporin, prednisone and azathioprine experienced rejection of the kidney, compared with 63 (47%) of the 134 adding placebo.
Slovenian: V drugi študiji je do zavrnitve ledvice prišlo pri 39 (28 %) od 141 odraslih bolnikov, pri katerih so zdravilo Zenapax dodajali ciklosporinu, prednizonu in azatioprinu, in pri 63 (47 %) od 134 odraslih bolnikov, pri katerih so ciklosporinu, prednizonu in azatioprinu dodajali placebo.
English: The full EPAR for Zenapax can be found here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zenapax je na voljo tukaj.
English: Why has Zenapax been approved?
Slovenian: Zakaj je bilo zdravilo Zenapax odobreno?
English: Both studies compared the effects of adding Zenapax or placebo (a dummy treatment) to other immunosuppressive medicines.
Slovenian: V študijah so primerjali učinke uporabe zdravila Zenapax ali placeba (zdravila brez zdravilne učinkovine) v kombinaciji z drugimi imunosupresivnimi zdravili.
English: Zenapax must not be used in women who are breast feeding.
Slovenian: Zdravila Zenapax ne smejo uporabljati doječe matere.
English: Zenapax was more effective than placebo in reducing the rate of rejection when added to immunosuppressive therapy.
Slovenian: Dodajanje zdravila Zenapax imunosupresivnim zdravilom je bilo glede stopnje zavrnitve učinkovitejše od dodajanja placeba.
English: Daclizumab has been designed to bind to the receptor for interleukin-2 on the surface of white blood cells called T-lymphocytes.
Slovenian: Daclizumab je zasnovan tako, da se veže na receptor za interlevkin-2, ki se nahaja na površini belih krvničk, ki jim pravimo limfociti T. Te celice sodelujejo pri prepoznavanju „tujih“ celic in zavračanju presajenih organov.
English: In studies, side effects were seen at similar rates in patients taking Zenapax and those taking placebo, when given in combination with immunosuppressive medicines.
Slovenian: V študijah so ugotovili, da se neželeni učinki pri bolnikih, ki so jemali zdravilo Zenapax v kombinaciji z imunosupresivnimi zdravili, pojavljajo s podobno pogostostjo kot pri bolnikih, katerim so dodajali placebo.
English: How does Zenapax work?
Slovenian: Kako zdravilo Zenapax deluje?
English: How has Zenapax been studied?
Slovenian: Kako je bilo zdravilo Zenapax raziskano?
English: What is Zenapax?
Slovenian: Kaj je zdravilo Zenapax?
English: What is Zenapax used for?
Slovenian: Za kaj se zdravilo Zenapax uporablja?
English: How is Zenapax used?
Slovenian: Kako se zdravilo Zenapax uporablja?
English: Produced from the plasma of human donors.
Slovenian: Proizvedeno iz plazme človeških darovalcev.
English: This must be carried out in hospital or under the careful supervision of a doctor.
Slovenian: To mora biti izvedeno v bolnišnici ali pod skrbnim nadzorom zdravnika.
English: The other (serious and non-serious) adverse reactions were received by spontaneous reporting.
Slovenian: Podatki o drugih (resnih in ne-resnih) neželenih učinkih so bili prejeti s spontanim poročanjem.
English: Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data)
Slovenian: Pogostost je bila ocenjena skladno z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (od ≥ 1/100 do < 1/10); občasni (od ≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: You should discuss the possible side effects with your doctor in order to know how to recognise them and what to do if they occur.
Slovenian: O možnih neželenih učinkih se pogovorite s svojim zdravnikom, da boste vedeli, kako jih prepoznati in kaj storiti, če se pojavijo.
English: Previously untreated patients
Slovenian: Predhodno nezdravljeni bolniki
English: The required dose is determined using the following formula:
Slovenian: Potrebno odmerjanje določimo z uporabo naslednje formule:
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Slovenian: Omogoča nadaljevanje spremljanja razmerja med koristmi in tveganji zdravila.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Slovenian: Če se taki inhibitorji pojavijo, se bo to pokazalo kot nezadosten klinični odziv.
English: This will show itself as an increased tendency to bleed.
Slovenian: To se bo pokazalo kot povečana nagnjenost h krvavitvam.
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki in škatli.
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, posebno pri mlajših bolnikih, bodo morda potrebni krajši intervali med odmerki ali višji odmerki.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih po pridobitvi dovoljenja za promet z zdravilom je pomembno.
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Slovenian: Trombin nato pretvori fibrinogen v fibrin in oblikuje se strdek.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature of 21°C.
Slovenian: Po pripravi: Kemijska in fizikalna stabilnost med uporabo je dokazana za 3 ure pri temperaturi 21 °C.
English: For safety information with respect to transmissible agents, see 4.4.
Slovenian: Za podatke o varnosti glede prenosljivih agensov glejte poglavje 4.4.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if the solution is not totally clear or if the powder is not totally reconstituted.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Ne uporabite, če raztopina ni popolnoma bistra ali če prašek ni popolnoma raztopljen.