FrancophonIA/ELRC3.0 huggingface dataset:
English: It is presented as 15- or 50-litre steel cylinders containing compressed oxygen gas.
Slovenian: Na voljo je v 15 ali 50 litrskih jeklenih cilindrih, ki vsebujejo kisik v obliki komprimiranega plina.
English: Oxygen is a well-established medical gas that has been in use for many years, and the company used information from the published literature.
Slovenian: Kisik je dobro znan medicinski plin, ki se uporablja že vrsto let, zato je podjetje uporabilo informacije iz objavljene literature.
English: Intervention with oxygen therapy is therefore important in certain cases to ensure adequate tissue oxygenation.
Slovenian: Posledično so posegi s kisikom v določenih primerih pomembni za zagotovitev ustrezne oksigenacije tkiva.
English: The principal risks associated with the use of this medicine are the inadvertent release of pressurised gas following incorrect use and the increased fire risks associated with localised increased oxygen concentrations.
Slovenian: Glavna tveganja, povezana z uporabo tega zdravila, so nehotena sprostitev komprimiranega plina zaradi nepravilne uporabe in povečana nevarnost požara, povezana z lokalno povečano koncentracijo kisika.
English: They provided satisfactory information on the quality, the safety of the medicine in dogs, cats and horses and its safety in humans (people in contact with the product) and the environment.
Slovenian: Predložili so zadovoljive informacije o kakovosti in varnosti zdravila pri psih, mačkah in konjih ter o njegovi varnosti pri ljudeh (ljudeh, ki so v stiku z njim) in za okolje.
English: Medicinal Oxygen has no side effects.
Slovenian: Zdravilo Medicinal Oxygen nima neželenih stranskih učinkov.
English: However, it is noted that the rate of oxygen supplementation required by an animal varies depending on a variety of factors, and that the appropriate oxygen ‘dose' to use during anaesthesia for a given animal must be established by the attending veterinarian, and continually monitored during anaesthesia.
Slovenian: Vendar pa je treba upoštevati, da je stopnja dodajanja kisika, potrebna za posamezno žival, odvisna od velikega števila dejavnikov, ter da mora ustrezen »odmerek« kisika za žival, uporabljen med anestezijo, določiti veterinar, ki izvaja poseg, odmerek pa je treba med anestezijo stalno nadzorovati.
English: It can also be used as a carrier gas for other gases used to anaesthetise the animal.
Slovenian: Lahko se uporablja tudi kot nosilni plin za druge pline, ki se uporabljajo za uspavanje živali.
English: EMEA/V/C/111 EMEA/CVMP/431314/2006 EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) MEDICINAL OXYGEN AIR LIQUIDE SANTÉ EPAR summary for the public
Slovenian: EMEA/V/C/111 EMEA/CVMP/13212/2007 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) MEDICINAL OXYGEN AIR LIQUIDE SANTÉ Povzetek EPAR za javnost
English: This product should only be used by persons who are trained in the use of compressed gas and associated equipment.
Slovenian: To zdravilo smejo uporabljati samo osebe, ki so usposobljene za uporabo komprimiranega plina in pripadajoče opreme.
English: It is absorbed from the air into the blood through the lungs (respiration).
Slovenian: Skozi pljuča se iz zraka absorbira v kri (dihanje).
English: Medicinal Oxygen contains oxygen extracted as a free gas from the atmosphere (the air we breathe).
Slovenian: Zdravilo Medicinal Oxygen vsebuje kisik, pridobljen kot nevezani plin iz atmosfere (zraka, ki ga dihamo).
English: It is also given after anaesthesia to help recovery.
Slovenian: Daje se tudi po anesteziji za hitrejše okrevanje.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of oxygen supplementation during anaesthesia and recovery in dogs, cats and horses exceed the risks associated with its use.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi dodajanja kisika med anestezijo in okrevanjem pri psih, mačkah in konjih večje od tveganj, povezanih z njegovo uporabo.
English: Further information was provided on the benefits of oxygen supplementation during anaesthesia and recovery.
Slovenian: Predložene so bile tudi informacije o koristih dodajanja kisika med anestezijo in okrevanjem.
English: Medicinal Oxygen is used to provide oxygen in dogs, cats and horses who have been anaesthetised and are not breathing naturally.
Slovenian: Zdravilo Medicinal Oxygen se uporablja za dovajanje kisika pri psih, mačkah in konjih, ki so anestezirani (uspavani) in ne dihajo naravno.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Medicinal Oxygen Air Liquide Santé to Air Liquide Santé International on 20.12.2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Medicinal Oxygen Air Liquide Santé, veljavno po vsej Evropski uniji, odobrila družbi Air Liquide Santé International dne 20.12.2006 Informacije o predpisovanju tega zdravila najdete na nalepki/zunanji ovojnini.
English: The literature provided by the Applicant supported the recommendations in the SPC for oxygen supplementation during anaesthesia and recovery in dogs, cats and horses.
Slovenian: Literatura, ki jo je predložil vlagatelj, podpira priporočila v Povzetku glavnih značilnosti zdravila glede dodajanja kisika med anestezijo in okrevanjem pri psih, mačkah in konjih.
English: Other information about Medicinal Oxygen Air Liquide Santé:
Slovenian: Druge informacije o zdravilu Medicinal Oxygen Air Liquide Santé:
English: What benefit has Medicinal Oxygen Air Liquide Santé shown during the studies?
Slovenian: Kakšne koristi je zdravilo Medicinal Oxygen Air Liquide Santé izkazalo med raziskavami?
English: What is the risk associated with Medicinal Oxygen Air Liquide Santé?
Slovenian: Kakšna tveganja so povezana z zdravilom Medicinal Oxygen Air Liquide Santé?
English: Why has Medicinal Oxygen Air Liquide Santé been approved?
Slovenian: Zakaj je bilo zdravilo Medicinal Oxygen Air Liquide Santé odobreno?
English: How has Medicinal Oxygen Air Liquide Santé been studied?
Slovenian: Kako je bilo zdravilo Medicinal Oxygen Air Liquide Santé raziskano?
English: What is Medicinal Oxygen Air Liquide Santé?
Slovenian: Kaj je zdravilo Medicinal Oxygen Air Liquide Santé?
English: How does Medicinal Oxygen Air Liquide Santé work?
Slovenian: Kako zdravilo Medicinal Oxygen Air Liquide Santé deluje?
English: What is Medicinal Oxygen Air Liquide Santé used for?
Slovenian: Za kaj se zdravilo Medicinal Oxygen Air Liquide Santé uporablja?
English: Preclinical and clinical safety
Slovenian: Predklinična in klinična varnost
English: • amendments in the product information in sections 4.1, 4.2, 4.3, 4.4, 4.6, 4.8 and 5.3 of the
Slovenian: • spremembo informacij o zdravilu v poglavjih 4.1, 4.2, 4.3, 4.4, 4.6, 4.8 in 5.3 povzetka glavnih značilnosti zdravila:
English: • introduce a contraindication in children, pregnant and lactating women;
Slovenian: • vključitev kontraindikacije pri otrocih, nosečnicah in ženskah, ki dojijo;
English: Alternative techniques (such as several types of local/regional anesthesics, general anesthesia, gas for inhalation) may be available.
Slovenian: Na voljo so lahko druge tehnike (na primer več vrst lokalnih/regionalnih anestetikov, splošna anestezija ali plin za inhaliranje).
English: Scientific conclusions and grounds for revocation of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za preklic dovoljenj za promet z zdravili
English: • Communication to Health Care Professionals concerning the instructions of use (via a dear Health Care Professional Communication and educational materials).
Slovenian: • obvestitev zdravstvenih delavcev o navodilih za uporabo (z neposrednim obvestilom zdravstvenim delavcem in izobraževalnim gradivom);
English: Finally, with regards to the reduction of exposure from 7 to 3 days, the CHMP does not find this measures acceptable since half of the periodontal necrosis cases reported in post-marketing period occurred within 3 days.
Slovenian: Kar zadeva skrajšanje izpostavljenosti s 7 na 3 dni, pa je odbor CHMP menil, da ti ukrepi niso sprejemljivi, saj se je polovica primerov nekroze obzobnih tkiv, o katerih so poročali v obdobju trženja, pojavila v 3 dneh.
English: The efficacy of the product is based on the above-mentioned single small prospective non-comparative study dated 1969, which estimated the efficacy in painless devitalisation of pulp to be 88% under optimal circumstances of use.
Slovenian: Učinkovitost zdravila temelji na zgoraj omenjeni edini majhni prospektivni neprimerjalni študiji iz leta 1969, v kateri je bila ocenjena učinkovitost zdravila pri neboleči devitalizaciji pulpe v optimalnih pogojih uporabe 88-odstotna.
English: • the efficacy was also high in case where it was not possible to place the product directly in contact with the pulp,
Slovenian: • da je bila učinkovitost visoka tudi takrat, ko zdravila ni bilo mogoče dati tako, da bi bilo v neposrednem stiku s pulpo,
English: The design of the study and the small number of subjects included did not allow a reliable assessment of the efficacy in a way to have a comparison with the current standard treatment.
Slovenian: Zaradi zasnove študije in majhnega števila sodelujočih ni bilo mogoče podati zanesljive ocene učinkovitosti, ki bi omogočala primerjavo s trenutnim standardnim zdravljenjem.
English: The provided study demonstrated low but measurable systemic level of arsenic after dental use.
Slovenian: Predložena študija je pokazala nizko, vendar opazno sistemsko raven arzena po dentalni uporabi.
English: The risk of carcinogenicity is established by the local or systemic passage of arsenic.
Slovenian: Tveganje za rakotvornost se pojavi pri lokalnem ali sistemskem prehajanju arzena.
English: Therefore, in accordance with Article 32 of Directive 2001/83/EC, the CHMP recommends the revocation of the marketing authorisations for all medicinal products referred to in Annex I pursuant to Article 116 of Directive 2001/83/EC.
Slovenian: Zato je v skladu s členom 32 Direktive 2001/83/ES priporočil preklic dovoljenj za promet z vsemi zdravili, navedenimi v Prilogi I, skladno s členom 116 Direktive 2001/83/ES.
English: • is carcinogenic in humans as stated by the IARC (Group 1),
Slovenian: • je rakotvoren za človeka v skladu z razvrstitvijo po IARC (skupina 1);
English: Therefore, the CHMP recommended the revocation of the marketing authorisations for the medicinal products referred to in Annex I.
Slovenian: Posledično je odbor CHMP priporočil preklic dovoljenj za promet z zdravili, navedenimi v Prilogi I.
English: In addition, for safety assessment, the CHMP noted that this short study does not confirm the absence of arsenic leakage, granulomas or decrease in bone density.
Slovenian: Poleg tega je odbor CHMP v okviru ocene varnosti izpostavil, da ta kratka študija ne potrjuje, da ne prihaja do uhajanja arzena, granulomov ali zmanjšanja gostote kosti.
English: • The monitoring and analysis of reported cases including a specific questionnaire to collect evidence of the indication of the product (use in second intention), sealing of the cavity and the duration of the application.
Slovenian: • spremljanje in analizo prijavljenih primerov, vključno s posebnim vprašalnikom, da bi zbrali dokaze v zvezi z indikacijo zdravila (uporaba kot zdravilo druge izbire), zapiranjem votline in trajanjem uporabe.
English: The CHMP considers that this risk is unacceptable taking into account the estimated benefit of the product and the existing safer alternatives.
Slovenian: Odbor CHMP je menil, da je to tveganje ob upoštevanju ocenjene koristi zdravila in obstoječih varnejših možnosti zdravljenja, nesprejemljivo.
English: Based on this positive genotoxicity results (clastogenicity) the MAHs informed the Competent Authorities of a potential serious impact on the benefit risk balance of the products.
Slovenian: Na podlagi teh pozitivnih rezultatov genotoksičnosti (klastogenosti) sta imetnika dovoljenja za promet z zdravilom obvestila pristojne organe o možnem resnem vplivu na razmerje med tveganji in koristmi teh zdravil.
English: • is genotoxic in vitro and in vivo in rodents (clastogenicity) which would not allow a safe level of use of arsenic trioxide for achieving active concentrations,
Slovenian: • je genotoksičen in vitro ter in vivo pri glodavcih (klastogenost), zaradi česar ne bi bila mogoča uporaba varnih količin arzenovega trioksida za doseganje učinkovitih koncentracij;
English: These products contain arsenous anhydride (arsenic trioxide) which is used for pulp cauterization (necrosis of the tooth pulp).
Slovenian: Zdravila vsebujejo arzenov anhidrid (arzenov trioksid), ki se uporablja za kavterizacijo pulpe (povzročitev odmrtja zobne pulpe).
English: In addition, the CHMP is of the view that the proposed measures to mitigate the risk of necrosis are not so different from the current recommendations and common knowledge on the conditions of use of the product and though the effectiveness of those current measures would not mitigate the risk associated with those products.
Slovenian: Poleg tega je odbor CHMP menil, da se predlagani ukrepi za zmanjšanje tveganja za nekrozo ne razlikujejo veliko od sedanjih priporočil ter splošnega znanja o pogojih uporabe zdravila in da kljub učinkovitosti teh sedanjih priporočil ne bi zmanjšali tveganja, povezanega s temi zdravili.
English: Finally the CHMP noted that the current international consensus for the recognition of ‘sufficient evidence in humans of the carcinogenicity' of arsenic trioxide along with the strict limitation of arsenic trioxide in the drinking water does no longer support the use of arsenic trioxide within the therapeutic armamentarium.
Slovenian: Odbor CHMP je izpostavil še, da sedanji mednarodni konsenz o priznanju „zadostnih dokazov pri človeku o rakotvornosti“ arzenovega trioksida skupaj s strogo omejitvijo arzenovega trioksida v pitni vodi ne podpira več uporabe arzenovega trioksida v sklopu zdravljenja.
English: A detailed analysis of the risks of clastogenicity or/and aneugenicity as those are recognised as a risk factor for cancer when impacting somatic cells, and teratogenicity, embryo-toxicity/spontaneous abortions and impaired male fertility, when impacting germinal cells.
Slovenian: Prav tako je bila izvedena podrobna analiza tveganj za klastogenost ali/in anevgenost, ki sta znana dejavnika tveganja za raka, kadar so prizadete somatske celice, in za teratogenost, embriotoksičnost/spontane splave ter zmanjšano plodnost moških, kadar so prizadete zarodne celice.
English: The MAH created in June 2013 an expert panel to characterise the risks and further assess the need for potential changes to the Marketing Authorisations (MAs) of the concerned product.
Slovenian: Imetnik dovoljenja za promet z zdravilom je junija 2013 imenoval skupino izvedencev, da bi opredelili tveganja in podrobneje ocenili potrebo po morebitnih spremembah dovoljenj za promet z zadevnim zdravilom.
English: • a number of ADRs have reported a lack of effect.
Slovenian: • da so v številnih poročilih o neželenih učinkih zdravila poročali o neučinkovitosti.
English: A literature review was performed by the Marketing Authorisations Holders (MAHs) (Septodont and A.T.O.
Slovenian: Imetnika dovoljenja za promet z zdravilom (Septodont in A.T.O.
English: This included the MAHs' responses, data available to Member States and published literature which became available since the original marketing authorisations.
Slovenian: Med njimi so bili odgovori imetnikov dovoljenja za promet z zdravilom, podatki, ki so na voljo državam članicam, in podatki iz objavljene literature, ki so postali na voljo po odobritvi prvotnih dovoljenj za promet zdravilom;
English: The French National Competent Authority (NCA) considered that the modifications of the SmPC proposed by the MAHs were neither acceptable nor appropriate given the genotoxicity data provided and the recommendation of the expert panel.
Slovenian: Francoski pristojni nacionalni organ je menil, da spremembe povzetka glavnih značilnosti zdravila, ki sta jih predlagala imetnika dovoljenja za promet z zdravilom, niso sprejemljive niti primerne glede na predložene podatke o genotoksičnosti in priporočilo skupine izvedencev.
English: In addition, following a review of the whole marketing authorisation supportive dossier a new information was highlighted by the MAH with regards to the systemic passage of arsenic that cannot be excluded.
Slovenian: Poleg tega je imetnik dovoljenja za promet z zdravilom po pregledu celotne dokumentacije v podporo vlogi za pridobitev dovoljenja za promet z zdravilom izpostavil nov podatek v zvezi s prehajanjem arzena v sistemski obtok, ki ga ni mogoče izključiti.
English: The MAHs provided an extensive review of all available data from pre-clinical, clinical studies and postmarketing experience.
Slovenian: Imetnika dovoljenja za promet z zdravilom sta predložila izčrpen pregled vseh razpoložljivih podatkov iz predkliničnih in kliničnih študij ter izkušenj v obdobju trženja.
English: To further address the risks of carcinogenicity and tissue necrosis and in response to the outstanding issues expressed by the CHMP, the MAHs propose the following additional risk minimisation measures:
Slovenian: Da bi dodatno zmanjšali tveganja za rakotvornost in nekrozo tkiv ter razrešili odprta vprašanja, ki jih je izpostavil odbor CHMP, sta imetnika dovoljenja za promet z zdravilom predlagala naslednje ukrepe za zmanjšanje tveganja:
English: The expert panel concluded that the benefit/risk of the product was negative.
Slovenian: Skupina izvedencev je zaključila, da je razmerje med tveganji in koristmi zdravila negativno.
English: The French NCA therefore referred the matter to the CHMP to give an opinion under Article 31 of Directive 2001/83/EC on whether the MAs of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use products should be maintained, varied, suspended or revoked.
Slovenian: Francoski pristojni nacionalni organ je zato zadevo napotil na odbor CHMP, da bi pridobil mnenje na podlagi člena 31 Direktive 2001/83/ES o tem, ali naj se dovoljenja za promet z zdraviloma Caustinerf arsenical in Yranicid arsenical ter drugimi povezanimi imeni za lokalno zdravljenje ohranijo, spremenijo, začasno umaknejo ali prekličejo.
English: • A drug utilisation study (DUS) in order to verify the comprehension of the indication, the awareness of the safety concern, the minimisation measures in the SmPC in term of restriction of indication, the new caution related use of the product at different time (e.g. when the restricted indication is implemented/ 6 months after the implementation/ 18 months after the implementation).
Slovenian: • študijo o uporabi zdravila, da bi preverili razumevanje indikacije, zavedanje o varnostnih tveganjih, ukrepe za zmanjšanje tveganja v povzetku glavnih značilnosti zdravila, ki se nanašajo na omejitev indikacije, in uporabo zdravila, ki bi po novem zahtevala previdnost, ob različnih časovnih točkah (npr. ob uveljavitvi omejene indikacije/6 mesecev po uveljavitvi/18 mesecev po uveljavitvi);
English: The CHMP is of the view that these risk minimisation measures would not be able to adequately reduce the risks associated to those products..
Slovenian: Odbor CHMP je menil, da ti ukrepi za zmanjšanje tveganja ne bi mogli v zadostni meri zmanjšati tveganj, povezanih z obravnavanimi zdravili.
English: The CHMP is of the view that the reported systemic exposure aggravates the earlier concern about the potential genotoxicity of the products.
Slovenian: Odbor CHMP je menil, da je zaradi opažene sistemske izpostavljenosti možna genotoksičnost zdravil še bolj zaskrbljujoča.
English: The CHMP also considered the overview of cases reported submitted by the MAHs which compiles safety data from a Global Safety Database as well as published literature and data available to the Member states.
Slovenian: Odbor CHMP je proučil tudi pregled poročil o primerih, ki sta ga predložila imetnika dovoljenja za promet z zdravilom in v katerem so bili zbrani podatki o varnosti iz svetovne baze podatkov o varnosti in objavljene literature, ter podatki, ki so na voljo državam članicam.
English: • has an impact on germinal cells and is reprotoxic in animals and humans, The CHMP is of the view that the overall risk of cancer, early foetal loss and impact on fertility associated with the use of Caustinerf arsenical, Yranicid arsenical and other medicinal products cannot be ruled out and the risk minimisation measures proposed by the MAHs will not allow avoiding the impact on human fertility.
Slovenian: • ima vpliv na zarodne celice in toksičen vpliv na sposobnost razmnoževanja pri živalih in ljudeh; Odbor CHMP je menil, da splošnega tveganja za raka, zgodnjo izgubo ploda in vpliv na plodnost, povezanega z uporabo zdravil Caustinerf arsenical in Yranicid arsenical ter drugih zdravil, ni mogoče izključiti, ukrepi za zmanjšanje tveganja, ki sta jih predlagala imetnika dovoljenja za promet z zdravilom, pa ne morejo preprečiti vpliva na plodnost pri človeku.
English: The CHMP concludes that arsenic trioxide:
Slovenian: Odbor CHMP je glede arzenovega trioksida zaključil, da:
English: The review of the available efficacy data (including data which became available since the initial marketing authorisation), showed limited efficacy of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use in its approved indication which does not translate in evidence of a benefit for patients in particular in the current context of the therapeutic strategy where the knowledge acquired in pulp's devitalisation and analgesia techniques has considerably improved, and where safer options are available.
Slovenian: Pregled razpoložljivih podatkov o učinkovitosti (vključno s podatki, ki so postali na voljo po odobritvi prvotnega dovoljenja za promet z zdravilom) je pokazal omejeno učinkovitost zdravil Caustinerf arsenical in Yranicid arsenical ter drugih povezanih imen za lokalno zdravljenje pri odobreni indikaciji, pri čemer ni dokazov o koristi za bolnike, še zlasti v okviru trenutnega načina zdravljenja, ko se je znanje, pridobljeno na področju devitalizacije pulpe in tehnik analgezije, znatno izboljšalo, na voljo pa so tudi varnejše možnosti.
English: The MAHs therefore applied for an USR to National Competent Authorities where the products are authorised, proposing to:
Slovenian: Imetnika dovoljenja za promet z zdravilom sta zato pristojnim nacionalnim organom držav, v katerih so zdravila odobrena, predložila vlogo za nujne varnostne ukrepe (USR) in predlagala:
English: With regards to the proposed DUS, the CHMP is of the opinion that it would not be ethically acceptable to expose patients to arsenic trioxide for which an expert panel concluded that a genotoxic, reprotoxic and carcinogenic risks have been demonstrated.
Slovenian: Glede predlagane študije o uporabi zdravila je odbor CHMP menil, da etično ne bi bilo sprejemljivo, da bi bolnike izpostavili arzenovemu trioksidu, za katerega je skupina izvedencev ugotovila, da je dokazano povezan s tveganji za genotoksičnost, vpliv na zmožnost razmnoževanja in rakotvornost.
English: After considering the data available and the risk minimisation measures proposed by the MAHs, the CHMP is of the view that the risk of osteonecrosis, soft tissue and dental necrosis, bone fistula and gingival discoloration is highly difficult to minimise or avoid.
Slovenian: Potem ko je proučil razpoložljive podatke in ukrepe za zmanjšanje tveganja, ki sta jih predlagala imetnika dovoljenja za promet z zdravilom, je odbor CHMP menil, da je tveganje za osteonekrozo, nekrozo mehkih tkiv in zobne pulpe, fistulo na kosti ter razbarvanje dlesni zelo težko zmanjšati ali preprečiti.
English: • The CHMP considered that the additional risk minimisation measures proposed by the Marketing Authorisation Holders would not be able to adequately reduce the risk of carcinogenicity and serious adverse reactions to a clinically acceptable level.
Slovenian: • odbor CHMP je menil, da z dodatnimi ukrepi za zmanjšanje tveganja, ki sta jih predlagala imetnika dovoljenja za promet z zdravilom, ne bi bilo mogoče zmanjšati tveganja za rakotvornost in resne neželene učinke na klinično sprejemljivo raven;