FrancophonIA/ELRC3.0 huggingface dataset:
English: Take the appropriate volume of Caelyx up into a sterile syringe.
Slovenian: Izvlecite ustrezni volumen zdravila Caelyx v sterilno brizgo.
English: Secondary haematological malignancies
Slovenian: Sekundarne hematološke maligne bolezni
English: Therefore, any patient treated with doxorubicin should be kept under haematological supervision.
Slovenian: Zato je treba vse bolnike, zdravljene z doksorubicinom, hematološko nadzorovati.
English: The suspension is sterile, translucent and red.
Slovenian: Suspenzija je sterilna, prosojna in rdeče barve.
English: During clinical trials in patients with solid tumours (including breast and ovarian cancer) who have received concomitant cyclophosphamide or taxanes, no new additive toxicities were noted.
Slovenian: Med kliničnimi raziskavami pri bolnikih s solidnimi tumorji (vključno z rakom dojk ali rakom jajčnikov), sočasno zdravljenih s ciklofosfamidom ali taksani, niso zasledili novih aditivnih toksičnih učinkov.
English: Following marketing, bullous eruption has been reported rarely in this population.
Slovenian: V obdobju trženja zdravila so pri tej populaciji poročali o redkih primerih z buloznim izpuščajem.
English: It is used to kill cancer cells, shrink the size of the tumour, delay the growth of the tumour, and extend your survival.
Slovenian: Zdravilo uničuje rakave celice, zmanjšuje velikost tumorja in upočasni njegovo rast ter podaljšuje preživetje bolnice.
English: In rare cases, having low white blood cells may lead to severe infection.
Slovenian: V redkih primerih lahko premajhno število levkocitov privede do hude okužbe.
English: If any signs or symptoms of extravasation occur (e.g., stinging, erythema) terminate the infusion immediately and restart in another vein.
Slovenian: Če se pojavijo kakršni koli znaki ali simptomi ekstravazacije (npr. občutek zbadanja, eritem), je treba infundiranje nemudoma prekiniti in infuzijo nastaviti na drugi veni.
English: Because the active ingredient doxorubicin hydrochloride in Caelyx may cause birth defects, it is important to tell your doctor if you think you are pregnant.
Slovenian: Ker lahko učinkovina zdravila Caelyx, doksorubicinijev klorid, povzroči prirojene napake pri novorojencu, je pomembno, da zdravniku poveste, če mislite, da ste noseči.
English: Increases in AST were less frequently (< 1%) reported.
Slovenian: O zvečanju koncentracije AST so poročali manj pogosto (< 1%).
English: What Caelyx is and what it is used for What you need to know before you use Caelyx How to use Caelyx
Slovenian: Kaj je zdravilo Caelyx in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Caelyx Kako uporabljati zdravilo Caelyx Možni neželeni učinki
English: Skin and subcutaneous tissue disorders rare lichenoid keratosis very rare erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis
Slovenian: Bolezni kože in podkožja redki lihenoidna keratoza zelo redki multiformni eritem, Stevens Johnson sindrom in toksična epidermalna nekroliza
English: Week 5
Slovenian: 5. teden
English: In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/m2-1,680 mg/m2.
Slovenian: Dodatno so endomiokardno biopsijo opravili tudi pri 8 bolnikih s solidnimi tumorji s kumulativnimi odmerki antraciklinov od 509 do 1.680 mg/m2.
English: The use of gloves is required.
Slovenian: Pri delu morate uporabljati rokavice.
English: This leaflet was last approved on
Slovenian: Navodilo je bilo nazadnje revidirano {MM/LLLL}
English: If no infusion reaction is observed, subsequent Caelyx infusions may be administered over a 60-minute period.
Slovenian: Če se ne pojavi infuzijska reakcija, lahko naslednje infuzije zdravila Caelyx date v 60 minutah.
English: The primary analysis of cardiac toxicity showed the risk of developing a cardiac event as a function of cumulative anthracycline dose was significantly lower with Caelyx than with doxorubicin (HR=3.16, p < 0.001).
Slovenian: Primarna analiza kardiotoksičnosti je pokazala, da je tveganje za kardialne sopojave kot funkcija kumulativnega odmerka antraciklina bistveno manjše pri zdravilu Caelyx kot pri standardnem doksorubicinu (HR = 3,16, p < 0,001).
English: Other strategies to prevent and treat PPE include keeping hands and feet cool, by exposing them to cool water (soaks, baths, or swimming), avoiding excessive heat/hot water and keeping them unrestricted (no socks, gloves, or shoes that are tight fitting).
Slovenian: Med drugimi načini za preprečevanje in zdravljenje PPE so hlajenje dlani in stopal s hladno vodo (namakanje, kopeli, plavanje), izogibanje prekomerni toploti ali topli vodi in skrb, da jih nič ne stiska (izogibanje nošenja nogavic, rokavic ali tesne obutve).
English: Evidence of penetration of pegylated liposomes from blood vessels and their entry and accumulation in tumours has been seen in mice with C-26 colon carcinoma tumours and in transgenic mice with KS-like lesions.
Slovenian: Znake prodiranja pegiliranih liposomov iz krvnih žil in njihovega vstopa ter kopičenja v tumorjih so opažali pri miših s karcinomskimi tumorji kolona C-26 in pri transgenskih miših z lezijami, podobnimi Kaposijevemu sarkomu.
English: Patient status
Slovenian: Stanje bolnika
English: The bortezomib regimen consists of 1.3 mg/m² on days 1, 4, 8, and 11 every 3 weeks.
Slovenian: Shema zdravljenja z bortezomibom sestoji iz infundiranja odmerkov po 1,3 mg/m² na 1., 4., 8. in 11. dan, na vsake 3 tedne.
English: Palmar-Plantar erythrodysesthesia Week after prior Caelyx dose
Slovenian: Palmarno-plantarna eritrodizestezija Teden po prejšnjem odmerku zdravila Caelyx
English: Whenever cardiomyopathy is suspected, i.e., the left ventricular ejection fraction has substantially decreased relative to pre-treatment values and/or left ventricular ejection fraction is lower than a prognostically relevant value (e.g., < 45%), endomyocardial biopsy may be considered and the benefit of continued therapy must be carefully evaluated against the risk of developing irreversible cardiac damage.
Slovenian: Kadarkoli se pojavi sum na kardiomiopatijo, tj. če se iztisni delež levega prekata bistveno zmanjša glede na vrednost pred začetkom zdravljenja in/ali je iztisni delež levega prekata manjši od prognostično relevantne vrednosti (npr. < 45%), po potrebi opravite endomiokardno biopsijo in skrbno pretehtajte koristi nadaljnjega zdravljenja v primerjavi s tveganjem za ireverzibilno okvaro srca.
English: As doxorubicin is metabolised by the liver and excreted in the bile, dose modification should not be required.
Slovenian: Ker se doksorubicin presnavlja v jetrih in izloča z žolčem, prilagoditev odmerka naj ne bi bila potrebna.
English: Growth factor support or transfusion support was necessary in 5.1% and 5.5% of patients, respectively (see section 4.2).
Slovenian: Podpora z dajanjem rastnega faktorja je bila potrebna pri 5,1% bolnikov, dajanje transfuzij pa pri 5,5% bolnikov (glejte poglavje 4.2).
English: The total dose of doxorubicin hydrochloride must also take into account any previous (or concomitant) therapy with cardiotoxic compounds such as other anthracyclines/anthraquinones or e.g., 5-fluorouracil.
Slovenian: Pri celokupnem odmerku doksorubicinijevega klorida morate upoštevati tudi morebitno predhodno ali sočasno zdravljenje s kardiotoksičnimi spojinami, npr. z drugimi antraciklini ali antrakinoni ali npr. 5-fluorouracilom.
English: In those patients who experience an infusion reaction, the method of infusion should be modified as follows:
Slovenian: Pri bolnicah z infuzijsko reakcijo prilagodite način infundiranja zdravila, kot sledi:
English: Caelyx is also used to produce an improvement in your Kaposi's sarcoma including flattening, lightening and even shrinkage of the cancer.
Slovenian: Zdravilo Caelyx se uporablja tudi za izboljšanje stanja pri Kaposijevem sarkomu, vključno s sploščenjem rakavih poškodb, njihovo posvetlitvijo in celo zmanjšanjem velikosti.
English: Prior to Caelyx administration, evaluate hepatic function using conventional clinical laboratory tests such as ALT/AST, alkaline phosphatase, and bilirubin.
Slovenian: Pred uporabo zdravila Caelyx morate oceniti delovanje jeter z običajnimi kliničnimi laboratorijskimi testi, npr. ALT/AST, alkalno fosfatazo in bilirubinom.
English: PPE*, alopecia, rash PPE*
Slovenian: PPE*, alopecija, izpuščaj
English: Avoid becoming pregnant while you or your partner are taking Caelyx and in the six months following discontinuation of Caelyx treatment.
Slovenian: Pazite, da ne zanosite v času, ko vi ali vaš partner prejemate zdravilo Caelyx, in še šest mesecev po prekinitvi zdravljenja z njim.
English: In nearly all patients, Caelyx treatment can be resumed after all symptoms have resolved without recurrence.
Slovenian: Pri skoraj vseh bolnikih lahko zdravljenje z zdravilom Caelyx nadaljujete, ko izginejo vsi simptomi, in ti se potem ne ponovijo.
English: In a subset of 410 patients with ovarian cancer, clinically significant laboratory abnormalities occurring in clinical trials with Caelyx included increases in total bilirubin (usually in patients with liver metastases) (5%) and serum creatinine levels (5%).
Slovenian: V podskupini 410 bolnic z rakom jajčnikov so bili med klinično pomembnimi nenormalnimi laboratorijskimi izvidi, ki so se pojavili v kliničnih preskušanjih z zdravilom Caelyx, zvečanje koncentracije celokupnega bilirubina (običajno pri bolnikih z jetrnimi metastazami) (5%) in serumske koncentracije kreatinina (5%).
English: The treatment HR for PFS when adjusted for prognostic variables was consistent with PFS for the ITT population.
Slovenian: Terapevtski HR za PFS, korigiran z upoštevanjem prognostičnih spremenljivk, je bil v skladu z vrednostjo PFS za populacijo, ki naj bi jo zdravili ("intent-to-treat").
English: Population pharmacokinetic data (in the range of creatinine clearance tested of 30-156 ml/min) demonstrate that Caelyx clearance is not influenced by renal function.
Slovenian: Podatki populacijske farmakokinetike (v testiranem razponu očistka kreatinina od 30 do 156 ml/min) kažejo, da delovanje ledvic ne vpliva na ledvični očistek zdravila Caelyx.
English: Some of these abnormalities may have been related to the underlying HIV infection and not Caelyx.
Slovenian: Nekateri od teh nenormalnih laboratorijskih izvidov so lahko posledica okužbe s HIV in ne uporabe zdravila Caelyx.
English: Rare side effects (may affect up to 1 in 1,000 people) - blue colour to the skin and mucosa caused by low oxygen in the blood; - patches of skin thickening.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - modro obarvana koža in sluznice zaradi nizke vsebnosti kisika v krvi, - zadebelitev delov kože.
English: Do not use Caelyx - if you are allergic to doxorubicin hydrochloride, peanut or soya, or any of the ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Caelyx - če ste alergični na doksorubicinijev klorid, arašide, sojo ali katero koli sestavino tega zdravila
English: Do not use material that shows evidence of precipitation or any other particulate matter.
Slovenian: Ne uporabljajte pripravka, ki kaže znake obarjanja ali vsebuje kakršnekoli druge vidne delce.
English: The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.
Slovenian: Odbor CHMP zato priporoča spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom.
English: Although local necrosis following extravasation has been reported very rarely, Caelyx is considered to be an irritant.
Slovenian: Čeprav so o lokalni nekrozi po ekstravazaciji poročali zelo redko, zdravilo Caelyx velja za dražečo snov.
English: Danmark Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 4594 8282
Slovenian: Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Week 6
Slovenian: 6. teden
English: Renal toxicity has been observed with even lower single doses of doxorubicin HCl in rats and rabbits.
Slovenian: Ledvično toksičnost pa so opažali tudi pri manjših enkratnih odmerkih doksorubicin klorida pri podganah in kuncih.
English: - In combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
Slovenian: - V kombinaciji z bortezomibom za zdravljenje napredovalega diseminiranega plazmocitoma pri bolnikih, ki so pred tem že prejeli najmanj eno vrsto predhodnega zdravljenja in so bodisi že imeli presaditev kostnega mozga ali pa niso primerni zanjo.
English: Infusion reactions rarely recur after the first treatment cycle.
Slovenian: Infuzijske reakcije se le redko ponovijo po prvem krogu kemoterapije.
English: In the pivotal trial in patients with ovarian cancer treated at a dose of 50 mg/m myelosuppression was generally mild to moderate, reversible, and was not associated with episodes of neutropaenic infection or sepsis.
Slovenian: V osrednji raziskavi pri bolnicah z rakom jajčnikov, zdravljenih z odmerkom 50 mg/m2, je bila mielosupresija na splošno blaga do zmerna in reverzibilna ter ni bila povezana z epizodami okužb zaradi nevtropenije ali sepso.
English: The cumulative dose at which cardiotoxicity would become a concern for these AIDS-KS patients (> 400 mg/m2) would require more than 20 courses of Caelyx therapy over 40 to 60 weeks.
Slovenian: Za dosego kumulativnega odmerka (> 400 mg/m2), pri katerem bi kardiotoksičnost pri teh bolnikih postala problem, bi bilo potrebnih več kot 20 krogov zdravljenja z zdravilom Caelyx v obdobju 40 do 60 tednov.
English: This is probably the result of intercalation of the anthracycline between adjacent base pairs of the DNA double helix thus preventing their unwinding for replication.
Slovenian: Do zavore verjetno pride zaradi vrivanja antraciklina med sosednje bazne pare dvojne vijačnice DNA, kar prepreči njeno razvitje, potrebno za podvojitev.
English: Furthermore, based on the pooled analysis of 4,231 patients across indications, the SmPC should be updated to in order to better detail the risk of cardiotoxicity associated with Caelyx.
Slovenian: Na podlagi analize združenih podatkov pri 4.321 bolnikih glede na indikacije, je treba posodobiti Povzetek glavnih značilnosti zdravila (SmPC), z namenom natančnejše opredelitve tveganja za pojav kardiotoksičnost pri uporabi zdravila Caelyx.
English: Grade 1 (mild erythema, swelling, or desquamation not interfering with daily activities)
Slovenian: Stopnja 1 (blag eritem, otekanje ali deskvamacija, ki ne ovira vsakodnevnih dejavnosti)
English: The evaluation tests and methods mentioned above concerning the monitoring of cardiac performance during anthracycline therapy are to be employed in the following order: ECG monitoring, measurement of left ventricular ejection fraction, endomyocardial biopsy.
Slovenian: Omenjene preiskave in postopke za oceno delovanja srca in njegovo spremljanje med zdravljenjem z antraciklini uporabljajte v naslednjem vrstnem redu: spremljanje EKG, merjenje iztisnega deleža levega prekata, endomiokardna biopsija.
English: Redose unless patient has experienced a previous grade 3 or 4 skin toxicity, in which case wait an additional week
Slovenian: Ponovite odmerek, razen če ni bolnik prej imel kožne toksičnosti 3. ali 4. stopnje; v tem primeru počakajte še en teden.
English: The pharmacokinetics of Caelyx over the dose range of 10 mg/m2 to 60 mg/m2 was best described by a two compartment non-linear model with zero order input and Michaelis-Menten elimination.
Slovenian: Farmakokinetiko zdravila Caelyx v odmernem območju od 10 do 60 mg/m2 najbolje opiše dvoprostorni nelinearni model z vnosom ničelnega reda in MichaelisMentenovim izločanjem.
English: Clinically significant laboratory abnormalities frequently ( 5%) occurred including increases in alkaline phosphatase; AST and bilirubin which were believed to be related to the underlying disease and not Caelyx.
Slovenian: Pogosto ( 5%) so se pojavljali klinično pomembni nenormalni laboratorijski izvidi, vključno z zvišanjem koncentracije alkalne fosfataze ter zvišanjem koncentracije AST in bilirubina, za katera menijo, da sta posledica osnovne bolezni in ne uporabe zdravila Caelyx.
English: Do not dose; if 2 or more doses are not given in a cycle, reduce dose by 25% in following cycles.
Slovenian: Ne infundirajte, če v posameznem krogu bolniku niste dali dveh ali več odmerkov, mu zmanjšajte odmerek za 25% v naslednjih krogih.
English: Bortezomib
Slovenian: Caelyx bortezomib
English: Leukopaenia is the most frequent undesirable effect experienced with Caelyx in this population; neutropaenia, anaemia and thrombocytopaenia have been observed.
Slovenian: Levkopenija je najpogostnejši neželeni učinek zdravila Caelyx v tej populaciji; ugotavljali so tudi nevtropenijo, anemijo in trombocitopenijo.
English: Solid tumour patients: in a larger cohort of 929 patients with solid tumours (including breast cancer and ovarian cancer) predominantly treated at a dose of 50 mg/m2 every 4 weeks, the safety profile and incidence of adverse effects are comparable to those of the patients treated in the pivotal breast cancer and ovarian cancer trials.
Slovenian: Bolnice s solidnimi tumorji: v večji kohorti 929 bolnikov s solidnimi tumorji (vključno z rakom dojk in rakom jajčnikov), ki so jih zdravili pretežno z odmerkom 50 mg/m vsake 4 tedne, sta bila profil neželenih učinkov zdravila in incidenca neželenih učinkov podobna kot pri bolnicah, zdravljenih v osrednjih preskušanjih raka dojk in raka jajčnikov.
English: The pegylated liposomes also have a low permeability lipid matrix and internal aqueous buffer system that combine to keep doxorubicin hydrochloride encapsulated during liposome residence time in circulation.
Slovenian: Pegilirani liposomi imajo tudi lipidni matriks majhne permeabilnosti in notranji vodni pufrski sistem, ki skupaj ohranjata doksorubicinijev klorid inkapsuliran, dokler liposomi krožijo v krvi.
English: Caelyx is administered as an intravenous infusion.
Slovenian: Zdravilo Caelyx se uporablja v obliki intravenske infuzije.
English: The dosage can be increased to full dose for subsequent cycles if tolerated.
Slovenian: Odmerek smete v naslednjih krogih povečati do polnega odmerka, če bolnik to dobro prenaša.
English: If a test result indicates possible cardiac injury associated with Caelyx therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury.
Slovenian: Če izvid pokaže možno okvaro srca v povezavi z zdravljenjem z zdravilom Caelyx, morate skrbno pretehtati koristnost nadaljnjega zdravljenja v primerjavi s tveganjem za okvaro miokarda.
English: To minimise the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute.
Slovenian: Da bi kar najbolj zmanjšali nevarnost infuzijskih reakcij, hitrost dajanja začetnega odmerka ne sme preseči 1 mg/minuto.
English: Caelyx is also used to treat cancer of the ovary.
Slovenian: Zdravilo Caelyx se uporablja tudi za zdravljenje raka jajčnikov.
English: Guidelines for Caelyx dose modification secondary to these adverse effects are provided in the tables below.
Slovenian: Smernice za prilagajanje odmerka zdravila Caelyx v primeru pojava teh neželenih učinkov so podane v spodnjih preglednicah.
English: Many patients treated with Caelyx have baseline myelosuppression due to such factors as their pre-existing HIV disease or numerous concomitant or previous medications, or tumours involving bone marrow.
Slovenian: Številni bolniki, zdravljeni z zdravilom Caelyx, imajo mielosupresijo že na začetku zdravljenja zaradi dejavnikov, kot so npr. obstoječa okužba s HIV, številna sočasna ali predhodno uporabljena zdravila ali pa infiltracija kostnega mozga.
English: Caelyx contains less than 1 mmol sodium (23 mg) per dose, that is to say ‘essentially sodium-free'.
Slovenian: Zdravilo Caelyx vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: The table for haematological toxicity (Table 3) provides the schedule followed for dose modification in clinical trials in the treatment of patients with breast or ovarian cancer only.
Slovenian: Preglednica za hematološko toksičnost (Preglednica 3) podaja shemo za prilagajanje odmerka, uporabljeno v kliničnih študijah le pri zdravljenju bolnic z rakom dojk ali rakom jajčnikov.
English: If the patient experiences early symptoms or signs of infusion reaction (see sections 4.4 and 4.8), immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.
Slovenian: Če se pojavijo zgodnji simptomi ali znaki infuzijske reakcije (glejte poglavji 4.4. in 4.8), infuzijo takoj prekinite, bolniku dajte ustrezno premedikacijo (antihistaminik in/ali kratkodelujoči kortikosteroid) in nato nadaljujte infuzijo z manjšo hitrostjo.
English: 5 How to store Caelyx Contents of the pack and other information
Slovenian: Shranjevanje zdravila Caelyx Vsebina pakiranja in dodatne informacije
English: Similar dermal lesions, which are described as palmar-plantar erythrodysesthesia were also observed in patients after long-term intravenous infusion (see section
Slovenian: Podobne kožne lezije, ki jih opisujejo kot palmo-plantarno eritrodizestezijo, so opažali tudi pri bolnikih po dolgotrajnih intravenskih infuzijah (glejte poglavje 4.8).
English: Caelyx contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells.
Slovenian: Zdravilo Caelyx vsebuje zdravilno učinkovino, ki deluje tako, da selektivno uničuje rakave celice.
English: Treatment will include administration of antibiotics, platelet cell transfusions, use of factors which stimulate production of white blood cells and symptomatic treatment of mouth sores.
Slovenian: Zdravljenje bo vključevalo uporabo obsega antibiotikov, transfuzij trombocitov, dajanje faktorjev, ki spodbujajo nastajanje levkocitov in simptomatsko zdravljenje razjed v ustih.
English: Ovarian cancer n=512
Slovenian: Rak jajčnikov n=512
English: Toxicity grade at current assessment
Slovenian: Trenutna ocena stopnje toksičnosti
English: If the patient experiences early symptoms or signs of infusion reaction, immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.
Slovenian: Če se pri bolniku pojavijo zgodnji simptomi ali znaki infuzijske reakcije, infuzijo takoj prekinite, mu dajte ustrezno premedikacijo (antihistaminik in/ali kratkodelujoči kortikosteroid) in nato infuzijo nadaljujte z manjšo hitrostjo.
English: The active ingredient of Caelyx is doxorubicin hydrochloride, a cytotoxic anthracycline antibiotic obtained from Streptomyces peucetius var. caesius.
Slovenian: Učinkovina zdravila Caelyx je doksorubicinijev klorid, ki je citotoksičen antraciklinski antibiotik, pridobljen iz Streptomyces peucetius var. caesius.
English: EU/1/96/011/001 (1 vial) EU/1/96/011/002 (10 vials)
Slovenian: EU/1/96/011/001 (1 viala) EU/1/96/011/002 (10 vial)
English: After dilution: - Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Slovenian: Po razredčenju: - Zdravilo je med uporabo kemično in fizikalno stabilno 24 ur pri temperaturi 2 °C do 8 °C.
English: EU/1/96/011/003 (1 vial) EU/1/96/011/004 (10 vials)
Slovenian: EU/1/96/011/003 (1 viala) EU/1/96/011/004 (10 vial)