FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory, thoracic and mediastinal disorders hypoxia, cough bronchospasm , dyspnoea, respiratory failure, lung infiltration, pulmonary oedema, pleural effusion, tachypnoea, laryngospasm
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora hipoksija, kašelj bronhospazem, dispneja, odpoved dihal, pljučni infiltrat, pljučni edem, plevralni izliv, tahipneja, laringospazem
English: Eye disorders may occur as dinutuximab beta binds to optic nerve cells.
Slovenian: Očesne bolezni se lahko pojavijo, ker se dinutuksimab beta veže na celice očesnega živca.
English: • For repeated daily infusions, the daily dose is 20 mg/m2 and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.
Slovenian: • Za ponavljajoče se vsakodnevne infuzije je dnevni odmerek 20 mg/m2, izračunani odmerek pa je treba razredčiti v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9 %), ki vsebuje 1 % humanega albumina.
English: Metabolism and nutrition disorders fluid retention decreased appetite, hypoalbuminaemia, hyponatraemia, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, dehydration
Slovenian: Presnovne in prehranske motnje zastajanje tekočine zmanjšan tek, hipoalbuminemija, hiponatriemija, hipokaliemija, hipofosfatemija, hipomagneziemija, hipokalciemija, dehidracija
English: 1 year 2 years
Slovenian: 1. leto 2. leto
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: For repeated daily 8-hour infusions, the daily dose is 20 mg/m2 and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.
Slovenian: Za ponavljajoče se vsakodnevne osemurne infuzije je dnevni odmerek 20 mg/m2, izračunani odmerek pa je treba razredčiti v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9 %), ki vsebuje 1 % humanega albumina.
English: Interrupt infusion, After resolution, resume infusion at 50% rate
Slovenian: Po odpravi neželenega učinka ponovno vzpostavite infuzijo s polovično hitrostjo.
English: Blood and lymphatic system disorders anaemia,leukopenia, neutropenia, thrombocytopenia lymphopenia disseminated intravascular coagulation, eosinophilia
Slovenian: Bolezni krvi in limfatičnega sistema anemija, levkopenija, nevtropenija, trombocitopenija limfopenija diseminirana intravaskularna koagulacija, eozinofilija
English: • adequate renal function: creatinine clearance or glomerular filtration rate (GRF)
Slovenian: • ustrezna ledvična funkcija: očistek kreatinina ali hitrost glomerulne filtracije (glomerular filtration rate - GFR) > 60 ml/min/1,73 m2.
English: Each vial contains 20 mg dinutuximab beta in 4.5 mL.
Slovenian: Ena viala vsebuje 20 mg dinutuksimaba beta v 4,5 ml.
English: Table 3: Event-free survival (EFS) and overall survival (OS) rates [95% confidence interval] in patients with evidence of disease at baseline (no complete response to initial treatment)
Slovenian: Preglednica 3: Stopnje preživetja brez dogodka (EFS) in skupnega preživetja (OS) [95-odstotni interval zaupanja] pri bolnikih z dokazi o bolezni v izhodišču (nepopoln odziv na začetno zdravljenje)
English: • problems with your nerves You may notice numbness, tingling or burning in your hands, feet, legs or arms, reduced sensation or weakness with movement.
Slovenian: Lahko boste občutili odrevenelost, mravljinčenje ali skelenje v dlaneh, stopalih, nogah ali rokah, zmanjšano občutljivost ali oslabelost pri gibanju.
English: Do not breast-feed during treatment with Qarziba and for 6 months after the last dose.
Slovenian: Med zdravljenjem z zdravilom Qarziba in še šest mesecev po zadnjem odmerku zdravila ne smete dojiti.
English: How to use Qarziba
Slovenian: Kako uporabljati zdravilo Qarziba
English: Immune system disorders hypersensitivity , cytokine release syndrome anaphylactic reaction serum sickness
Slovenian: Bolezni imunskega sistema preobčutljivost, sindrom sproščanja citokinov anafilaktična reakcija serumska bolezen
English: Discontinue infusion, Resume next day if ADR resolves
Slovenian: Če je neželeni učinek odpravljen, nadaljujte naslednji dan.
English: • inflammation of the intestine, injury to the liver
Slovenian: • vnetje črevesja, poškodbe jeter
English: • The active substance is dinutuximab beta.
Slovenian: • Zdravilna učinkovina je dinutuksimab beta.
English: IL-2 is administered as 6×106 IU/m2/day, resulting in an overall dose of 60×106 IU/m2/course.
Slovenian: Interlevkin-2 se daje v odmerku 6 × 106 i. e./m2/dan, tako da bolnik prejme skupni odmerek 60 × 106 i. e./m2/cikel.
English: NAME OF THE MEDICINAL PRODUCT Qarziba 4.5 mg/mL concentrate for solution for infusion
Slovenian: IME ZDRAVILA Qarziba 4,5 mg/ml koncentrat za raztopino za infundiranje
English: Severe infusion-related reactions, including cytokine release syndrome (CRS), anaphylactic and hypersensitivity reactions, may occur despite the use of premedication.
Slovenian: Kljub uporabi premedikacije se lahko pojavijo hude reakcije, povezane z infundiranjem, vključno s sindromom sproščanja citokinov (cytokine release syndrome - CRS), anafilaktičnimi in preobčutljivostnimi reakcijami.
English: What you need to know before you use Qarziba
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Qarziba Ne uporabljajte zdravila Qarziba,
English: Qarziba should be diluted aseptically to the patient-specific concentration/dose with sodium chloride 9 mg/mL (0.9%) solution for infusion, containing 1% human albumin (e.g. 5 mL of human albumin 20% per 100 mL sodium chloride solution).
Slovenian: Zdravilo Qarziba je treba aseptično razredčiti do koncentracije/odmerka za posameznega bolnika z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, ki vsebuje 1 % humanega albumina (npr. 5 ml 20-odstotnega humanega albumina na 100 ml raztopine natrijevega klorida.
English: ophthalmoplegia, papilloedema, accommodation disorder, blurred vision, photophobia
Slovenian: oftalmoplegija, edem papile vidnega živca, motnje akomodacije, zamegljen vid, fotofobija
English: Other side effects and their frequencies include: Very common (may affect more than 1 in 10 people):
Slovenian: Če opazite kar koli od naslednjega, takoj povejte z zdravniku ali medicinski sestri: Zelo pogosti (pojavijo se lahko pri več kot 1 bolniku od 10):
English: You might notice the following when you first receive Qarziba and during the course of treatment:
Slovenian: Ko boste prvič prejeli zdravilo Qarziba in med zdravljenjem z njim, boste morda opazili naslednje znake:
English: Qarziba is a clear, colourless liquid, provided in a clear glass vial with a rubber stopper and aluminium seal.
Slovenian: Zdravilo Qarziba je prozorna, brezbarvna tekočina v prozorni stekleni viali z gumijastim zamaškom in aluminijasto zaporko.
English: 1 year
Slovenian: 1. leto
English: • decreased appetite, nausea, abdominal distension, accumulation of fluid in the abdominal cavity
Slovenian: • zmanjšan tek, slabost, napetost v trebuhu, kopičenje tekočine v trebušni votlini
English: • a brain disorder characterised by headache, confusion, seizures and loss of vision (posterior reversible encephalopathy syndrome)
Slovenian: • motnja možganov, za katero so značilni glavobol, zmedenost, napadi krčev in izguba vida
English: General disorders and administration site conditions pyrexia, chills, pain*, peripheral oedema, face oedema injection site reaction
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija, mrzlica, bolečine*, periferni edem, otekanje obraza reakcije na mestu injiciranja
English: Cardiac disorders tachycardia cardiac failure, left ventricular dysfunction, pericardial effusion
Slovenian: Srčne bolezni tahikardija srčno popuščanje, disfunkcija levega prekata, perikardni izliv
English: It is recommended to prepare 50 mL solution in a 50 mL syringe, or 250 mL in an infusion bag suitable for the employed infusion pump, i.e. an overfill of 2 mL (syringe) or 10 mL (infusion bag) to allow for dead volumes of the infusion systems.
Slovenian: Količina raztopine, ki bo infundirana na dan (v okviru cikla zdravljenja, ki obsega deset zaporednih dni), mora biti 48 ml, za petdnevni odmerek pa 240 ml. Priporočljiva je priprava 50 ml raztopine v 50-ml brizgi ali 250 ml v infuzijski vrečki, primerni za uporabo z infuzijsko črpalko, pri čemer je treba upoštevati presežek 2 ml (brizga) ali 10 ml (infuzijska vrečka), ki zapolni mrtvo prostornino infuzijskih sistemov.
English: Rapid drop in blood pressure, light-headedness and breathing difficulties are further signs.
Slovenian: Drugi znaki so nenaden padec krvnega tlaka, omotičnost in težave z dihanjem.
English: Refractory patients
Slovenian: Posebne skupine bolnikov
English: Gastrointestinal disorders vomiting , diarrhoea, constipation, stomatitis nausea, lip oedema, ascites, abdominal distension, ileus, dry lips enterocolitis
Slovenian: Bolezni prebavil bruhanje, driska, zaprtost, stomatitis navzea, edem ustnic, ascites, abdominalna distenzija, ileus, suhe ustnice enterokolitis
English: 1 mL concentrate contains 4.5 mg dinutuximab beta.
Slovenian: 1 ml koncentrata vsebuje 4,5 mg dinutuksimaba beta.
English: • kidney failure
Slovenian: • napadi krčev
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Qarziba 4.5 mg/mL concentrate for solution for infusion dinutuximab beta
Slovenian: IME ZDRAVILA IN POT(-I) UPORABE Qarziba 4,5 mg/ml koncentrat za raztopino za infundiranje dinutuksimab beta intravenska uporaba
English: Interrupt infusion and administer supportive measures, Resume at 50% rate if ADR resolves or improves to Grade 1 - 2
Slovenian: Ponovno vzpostavite infuzijo s polovično hitrostjo, če je neželeni učinek odpravljen ali če se izboljša do stopnje 1 ali 2.
English: Renal and urinary disorders oliguria, urinary retention, hyperphosphaturia, haematuria, proteinuria renal failure
Slovenian: Bolezni ledvic in sečil oligurija, zastajanje urina, hiperfosfaturija, hematurija, proteinurija odpoved ledvic
English: Occasional occurrences of peripheral neuropathy have been reported with Qarziba.
Slovenian: Pri zdravljenju z zdravilom Qarziba so poročali o občasnem pojavljanju periferne nevropatije.
English: • vomiting, diarrhoea, constipation
Slovenian: • bruhanje, driska, zaprtje
English: The primary efficacy endpoint was 3-year EFS and secondary endpoint was OS. EFS and OS rates are presented in Tables 2 and 3 according to the evidence of disease at baseline.
Slovenian: Stopnje preživetja brez dogodka in skupnega preživetja so predstavljene v preglednicah 2 in 3, glede na dokaze o bolezni v izhodišču.
English: Avoid vaccinations during treatment with Qarziba and for 10 weeks afterwards.
Slovenian: Med zdravljenjem z zdravilom Qarziba in deset tednov po zaključku zdravljenja se morate izogibati cepljenjem.
English: • allergic reactions or other infusion-related reactions Tell your doctor or nurse if you have any kind of reaction during or after the infusion, such as: fever, shivering and/or low blood pressure difficulties in breathing skin rash, hives You will receive appropriate treatment to prevent these reactions and be closely monitored for these symptoms during infusion of Qarziba.
Slovenian: • alergijske reakcije ali druge reakcije, povezane z infuzijo Obvestite svojega zdravnika ali medicinsko sestro, če se pojavi katera koli reakcija med infuzijo ali po njej, kot so npr.:
English: Each 4.5 mL vial contains 20 mg dinutuximab beta.
Slovenian: ena 4,5-mililitrska viala vsebuje 20 mg dinutuksimaba beta.
English: Qarziba 4.5 mg/mL concentrate for solution for infusion dinutuximab beta
Slovenian: Qarziba 4,5 mg/ml koncentrat za raztopino za infundiranje dinutuksimab beta
English: Recommended dose modifications for dinutuximab beta Adverse reaction Severity
Slovenian: Priporočene prilagoditve odmerka dinutuksimaba beta
English: Talk to your doctor before you receive Qarziba if you are of childbearing age.
Slovenian: Če ste ženska v rodni dobi, se posvetujte z zdravnikom, preden prejmete zdravilo Qarziba.
English: Hypersensitivity reaction e.g. hypotension
Slovenian: Preobčutljivostna reakcija npr. hipotenzija
English: Eye disorders mydriasis, pupillotonia, eye oedema (eyelid, periorbital)
Slovenian: Očesne bolezni midriaza, pupilotonija, očesni edem (edem veke ali periorbitalni edem)
English: In order to evaluate the add-on effect of IL-2 in patients with relapsed refractory neuroblastoma, the MAH will submit the results of study APN311202v3.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za oceno dodatnega učinka IL-2 pri bolnikih z recidivnim/neodzivnim nevroblastomom predložiti rezultate študije APN311-202v3.
English: There are no data on pregnant women.
Slovenian: Podatkov o uporabi dinutuksimaba beta pri nosečnicah ni.
English: Neuropathic pain usually occurs at the beginning of the treatment and premedication with analgesics, including intravenous opioids, prior to each infusion of dinutuximab beta is required.
Slovenian: Pred vsako infuzijo dinutuksimaba beta je treba uporabiti premedikacijo z analgetiki, vključno z intravenskimi opioidi.
English: • have acute grade 3 or 4, or extensive long-lasting graft-versus-host disease This disease is a reaction in which cells of transplanted tissue attack cells of the recipient.
Slovenian: Ta bolezen je reakcija, pri kateri celice presajenega tkiva napadajo celice prejemnika.
English: It is unknown whether dinutuximab beta is excreted in human milk.
Slovenian: Podatkov o uporabi dinutuksimaba beta pri doječih ženskah ni. Ni znano, ali se dinutuksimab beta izloča v materino mleko.
English: • grade 3 vision eye toxicity
Slovenian: • toksičnost za vid oz. oko stopnje 3,
English: Hydrochloric acid (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi histidin saharoza polisorbat 20 voda za injekcije klorovodikova kislina (za prilagoditev pH)
English: What Qarziba contains
Slovenian: Kaj vsebuje zdravilo Qarziba
English: Breast-feeding should be discontinued during treatment with Qarziba and for 6 months after the last dose.
Slovenian: Ženske morajo med zdravljenjem z zdravilom Qarziba prekiniti dojenje in ne smejo dojiti še vsaj šest mesecev po zadnjem odmerku.
English: Recurrent
Slovenian: Opioidi
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of concentrate contains 4.5 mg dinutuximab beta.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN 1 ml koncentrata vsebuje 4,5 mg dinutuksimaba beta.
English: Water for injections
Slovenian: Dajanje infuzije
English: Decrease infusion rate to 50%, After resolution, resume infusion at original rate
Slovenian: Po odpravi neželenega učinka ponovno vzpostavite prvotno hitrost infuzije.
English: breathing difficulties, dizziness, hives, rapid or noticeable heartbeat, low blood pressure, hives,
Slovenian: povišana telesna temperatura, drgetanje in/ali nizek krvni tlak težave z dihanjem kožni izpuščaj, koprivnica.
English: Tell your doctor immediately if you notice any of these problems.
Slovenian: Če se pri vas pojavi kateri koli od navedenih simptomov, takoj obvestite zdravnika.
English: > 60 mL/min/1.73 m2
Slovenian: 10 mg/m2
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY MEMBER STATES
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UVESTI DRŽAVE ČLANICE
English: The information pack should contain the following:
Slovenian: Izobraževalno gradivo mora vsebovati naslednje:
English: The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on the correct prescription of Esbriet.
Slovenian: Preden imetnik dovoljenja za promet z zdravilom da zdravilo v promet, mora v dogovoru s pristojnimi organi držav članic izvesti izobraževalni program za zdravnike, katerega cilj je zagotoviti izobraževalno gradivo o pravilnem predpisovanju zdravila Esbriet.
English: • Patients are advised to avoid or reduce exposure to direct sunlight (including sunlamps).
Slovenian: • Bolnikom je treba svetovati, naj se izogibajo izpostavljenosti neposredni sončni svetlobi ali jo zmanjšajo (vključno s svetilkami za sončenje).
English: • Physician information (safety checklists)
Slovenian: • informacije za zdravnike (kontrolne sezname za zagotavljanje varnosti);
English: • Patients should be instructed to use a sunblock daily, to wear clothing that protects against sun exposure, and to avoid other medications known to cause photosensitivity.
Slovenian: • Bolnikom je treba naročiti, naj vsak dan uporabljajo kremo za sončenje, nosijo oblačila, ki jih ščitijo pred izpostavljenostjo soncu, in se izogibajo drugim zdravilom, za katera je znano, da povzročajo preobčutljivost na svetlobo.
English: • Photosensitivity reactions and skin rashes
Slovenian: • reakcije preobčutljivosti na svetlobo in kožne izpuščaje;
English: • Esbriet is contraindicated in patients with severe hepatic impairment or end stage liver disease.
Slovenian: • Zdravilo Esbriet je kontraindicirano za bolnike s hudo okvaro ali končno odpovedjo jeter.
English: • Abnormal liver function tests
Slovenian: • nenormalne rezultate testov delovanja jeter;
English: • Any other clinically significant ADRs based on the judgment of the prescriber
Slovenian: • katerekoli druge klinično pomembne neželene učinke po presoji zdravnika, ki predpiše zdravilo.
English: • Elevations of serum transaminases can occur during treatment with Esbriet.
Slovenian: • Med zdravljenjem z zdravilom Esbriet se lahko poviša raven transaminaz v serumu.
English: • There is a need to monitor liver function tests prior to initiation of treatment with Esbriet and at regular intervals thereafter.
Slovenian: • Pred začetkom zdravljenja z zdravilom Esbriet je treba preveriti delovanje jeter in ga nato redno spremljati.
English: • Patients should be informed that Esbriet is known to be associated with photosensitivity reactions and that preventative measures have to be taken.
Slovenian: • Bolnike je treba obvestiti, da se pri jemanju zdravila Esbriet lahko pojavijo reakcije preobčutljivosti na svetlobo in da je treba izvesti ustrezne zaščitne ukrepe.
English: • Close monitoring is required of any patients who develop liver enzyme elevation with appropriate dose adjustment or discontinuation.
Slovenian: • Bolnike, pri katerih se je pojavilo povišanje jetrnih encimov, je treba pozorno spremljati in po potrebi prilagoditi odmerek ali prekiniti zdravljenje.
English: • Patient information (PIL)
Slovenian: • informacije za bolnike (navodilo za uporabo).
English: Do not use after {Month/Year}.
Slovenian: Ne uporabljaj po {Mesec/Leto}.
English: 4.4 Special warnings <for each target species> None.
Slovenian: 4.4 Posebna opozorila <za vsako ciljno živalsko vrsto> Jih ni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Aktivna sestavina:
English: 100 % oxygen.
Slovenian: 100 % kisik.
English: Dogs, cats and horses.
Slovenian: Psi, mačke in konji.
English: Following these catalytic reactions it reappears in the form of CO2 and H2O.
Slovenian: Po tem katalitičnim procesu se ponovno pojavi v obliki CO2 and H2O.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na razpolago na spletni strani Evropske agencije za evaluacijo zdravil (EMEA) http://www.emea.europa.eu/
English: SPECIAL WARNING(S), IF NECESSARY Keep away from naked flames.
Slovenian: POSEBNO OPOZORILO(A), ČE JE/SO POTREBNO(A) Zavarujte pred odprtim ognjem.
English: PHARMACEUTICAL FORM Inhalation gas.
Slovenian: FARMACEVTSKA OBLIKA Inhalacijski plin.
English: Do not lubricate.
Slovenian: Ne naoljite.
English: Full and empty cylinders should be stored separately.
Slovenian: Polne in prazne cilindre shranjujte ločeno.
English: The variation of the partial pressure of oxygen in the blood affects the cardiovascular system, the respiratory system, cellular metabolism, and the central nervous system.
Slovenian: Sprememba delnega pritiska kisika v krvi vpliva na kardiovaskularni system, dihalni sistem, celični metabolizem in osrednji živčni sistem.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO “SAMO ZA ZDRAVLJENJE ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 100 % oxygen.
Slovenian: NAVEDBA ZDRAVILNIH/AKTIVNIH UČINKOVIN IN DRUGIH SNOVI 100 % kisik.
English: TARGET SPECIES Dogs, cats and horses.
Slovenian: CILJNE ŽIVALSKE VRSTE Psi, mačke in konji.
English: Pharmacotherapeutic group: Medical Gases, ATCvet code: QV03AN01.
Slovenian: Farmakološka skupina: Medical Gases, ATCvet koda: QV03AN01.
English: Oxygen in concentration over 80 % (FiO2 0.8) should not exceed 18 hours.
Slovenian: Kisik v koncentraciji preko 80% (FiO2 0.8) ne sme preseči 18 ur.
English: It is involved in cellular metabolism and catabolism and permits production of energy in the form of adenosine triphosphate (ATP).
Slovenian: Vključen je v celični metabolizem in katabolizem in zagotavlja prizvodnjo energije v obliki adenozin trifosfata (ATP).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: NAČINI IN POT(I) UPORABE Pred uporabo preberite navodila za uporabo.
English: If you have been working in an oxygen-enriched atmosphere avoid smoking, open flames or other sources of ignition for at least 15 minutes.
Slovenian: Če ste delali v prostoru, obogatenem s kisikom, vsaj 15 minut ne kadite, ne uporabljajte odprtega ognja in drugih virov vžiga.
English: No smoking.
Slovenian: Prepovedano kajenje.
English: Cylinders should be protected from falling, from being hit, from sources of heat or ignition, from temperatures of more than 50 °C and from combustible materials.
Slovenian: Cilindri morajo biti zavarovani pred padci, udarci, pred viri toplote ali vžiga, pred temperaturami nad 50 °C in pred vnetljivimi materiali.
English: Adverse effects can occur if mammals are exposed to excessive levels of oxygen for long periods of time or if high levels of oxygen are administered under hyperbaric conditions.
Slovenian: Neželeni učinki se lahko pojavijo, če so sesalci izpostavljeni prekomernim deležem kisika v daljšem časovnem obdobju ali če so visoki deleži kisika uporabljeni v hiperbaričnih pogojih.
English: Unwanted partially full, or empty, Medicinal Oxygen Air Liquide Santé cylinders should be returned to the manufacturer or their authorised distributor.
Slovenian: Nepotrebne, delno polne ali prazne cilindre z Medicinal Oxygen Air Liquide Santé je treba vrniti proizvajalcu ali njihovemu pooblaščenemu distributerju.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: DODATEK I POVZETEK ZNAČILNOSTI ZDRAVILA
English: Since even the smallest spark can cause violent ignition, electrical equipment capable of sparking should not be used in the vicinity of patients receiving oxygen.
Slovenian: Ker že najmanjša iskrica lahko povzroči silovit vžig, uporaba električne opreme, ki lahko povzroči iskrenje, ni dovoljena v bližini pacientov, ki dobivajo kisik.
English: For oxygen supplementation during recovery.
Slovenian: Za dodajanje kisika med okrevanjem.
English: Cylinders should be stored in a locked, clean and ventilated area reserved for the storage of medical gases, protected from weather and with no inflammable materials.
Slovenian: Cilindre shranjujte v zaklenjenem, čistem in prezračenem prostoru za shranjevanje medicinskih plinov, zavarovanem pred vremenskimi vplivi in brez vnetljivih materialov.
English: 10, rue Cognacq-Jay 75341 Paris Cedex 07 FRANCE
Slovenian: 10, rue Cognacq-Jay 75341 Paris Cedex 07 FRANCIJA
English: 15 l cylinders filled at 200 bar, containing 3.2 m³ oxygen under a pressure of 1 bar at 15 ºC.
Slovenian: 15 l cilinder, polnjen pri 200 barih, ki vsebujejo 3.2 m³ kisika pod pritiskom 1 bar pri 15 ºC.