FrancophonIA/ELRC3.0 huggingface dataset:
English: This can be attached to the patient's notes so that hospital staff are made aware of these effects of the medicine.
Slovenian: Ta nalepka se lahko nalepi v bolnikovo kartoteko, da je zdravstveno osebje obveščeno o teh učinkih zdravila.
English: For more information about treatment with Cyanokit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Cyanokit preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For adults, the initial dose is 5 g. For children, it is 70 mg per kilogram body weight up to a maximum dose of 5 g. A second dose can be given, depending on how severe the poisoning is and how well the patient is responding.
Slovenian: Začetni odmerek za odrasle je 5 g, za otroke pa 70 mg na kilogram telesne mase do največ 5 g. Glede na resnost zastrupitve in odziv bolnika se lahko da še en odmerek.
English: This helps to reduce the effects of cyanide poisoning.
Slovenian: S tem se zmanjšajo učinki zastrupitve s cianidom.
English: Other information about Cyanokit
Slovenian: Druge informacije o zdravilu Cyanokit:
English: Because hydroxocobalamin has an intense red colour, most patients will have dark red colouring of the skin and mucous membranes for up to 15 days and of the urine for up to 35 days after receiving Cyanokit.
Slovenian: Ker ima hidroksokobalamin intenzivno rdečo barvo, se pri večini bolnikov po prejemu zdravila Cyanokit temno rdeče obarvajo koža in sluznice (do 15 dni) ter seč (do 35 dni).
English: A risk management plan has been developed to ensure that Cyanokit is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Cyanokit je bil pripravljen načrt obvladovanja tveganj.
English: What benefit has Cyanokit shown during the studies?
Slovenian: Kakšne koristi je zdravilo Cyanokit izkazalo med študijami?
English: Therefore, the CHMP decided that Cyanokit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je odbor CHMP zaključil, da so koristi zdravila Cyanokit večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
English: Information on its effectiveness was obtained in 83 patients who had been admitted to hospital with suspected cyanide poisoning and who received Cyanokit.
Slovenian: Učinkovitost so ugotavljali pri 83 bolnikih, ki so bili sprejeti v bolnišnico s sumom zastrupitve s cianidom in ki so prejeli zdravilo Cyanokit.
English: In this study, the patients' condition at the accident scene was compared with that at the end of the infusion of Cyanokit and over the following three days.
Slovenian: V tej študiji so primerjali stanje bolnikov na mestu nezgode s stanjem po koncu infundiranja zdravila Cyanokit ter stanjem v naslednjih treh dneh.
English: Cyanide poisoning usually results from exposure to smoke from fire, from breathing or swallowing cyanide, or from getting it onto the skin or mucous membranes (moist body surfaces, such as the lining of the mouth).
Slovenian: Zastrupitev s cianidom je navadno posledica izpostavljenosti dimu pri požarih, vdihavanja ali zaužitja cianida ali stika z njim prek kože ali sluznice (vlažne površine telesa, npr. v ustih).
English: It contains the active substance hydroxocobalamin (vitamin B12a).
Slovenian: Vsebuje zdravilno učinkovino hidroksokobalamin (vitamin B12a).
English: Cyanokit is given along with other appropriate decontamination and supportive measures, including providing oxygen for the patient to breathe.
Slovenian: Zdravilo Cyanokit se uporablja skupaj z ustreznimi ukrepi za dekontaminacijo in oskrbo bolnika, vključno z dovajanjem kisika za dihanje.
English: This lowers cyanide levels in the body and stops the cyanide fixing itself to an enzyme in cells called cytochrome oxidase, which is important for providing energy in cells.
Slovenian: S tem se znižajo ravni cianida v telesu in prepreči vezava cianida na celični encim citokrom-oksidazo, ki je pomemben za zagotavljanje energije v celicah.
English: Survival was more likely in those who received Cyanokit before their hearts had stopped, who had less severe symptoms of brain damage and who had lower blood cyanide levels.
Slovenian: Preživetje je bilo bolj verjetno pri bolnikih, ki so prejeli zdravilo Cyanokit, preden se jim je ustavilo srce, pri bolnikih, ki so imeli blažje simptome možganske poškodbe in ki so imeli nižje ravni cianida v krvi.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cyanokit.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cyanokit, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Two patients survived despite their hearts having stopped before receiving Cyanokit.
Slovenian: Dva bolnika sta preživela, čeprav je prišlo do zastoja srca pred prejemom zdravila Cyanokit.
English: However, the CHMP concluded that Cyanokit had advantages over alternative antidotes because it has a good safety profile in patients who have not been poisoned.
Slovenian: Vendar je Odbor mnenja, da ima zdravilo Cyanokit prednosti pred ostalimi protistrupi, ker ima dober varnostni profil pri bolnikih, ki niso bili zastrupljeni.
English: In one study of 69 patients, cyanide poisoning was due to exposure to smoke from fire.
Slovenian: V eni študiji, ki je vključevala 69 bolnikov, je do zastrupitve s cianidom prišlo zaradi izpostavitve dimu v požaru.
English: What is the risk associated with Cyanokit?
Slovenian: Kakšna tveganja so povezana z zdravilom Cyanokit?
English: Of the 14 patients whose cyanide exposure was due to something other than smoke inhalation, 10 survived, including seven patients with ‘lethal' levels of cyanide in the blood.
Slovenian: Izmed 14 bolnikov, pri katerih zastrupitev s cianidom ni bila posledica vdihavanja dima, jih je 10 preživelo, vključno s sedmimi bolniki, ki so imeli v krvi „smrtne“ ravni cianida.
English: The active substance in Cyanokit, hydroxocobalamin, reacts with cyanide in the body to form cyanocobalamin, a non-poisonous compound that is removed from the body in the urine.
Slovenian: Zdravilna učinkovina v zdravilu Cyanokit, hidroksokobalamin, v telesu reagira s cianidom in tvori cianokobalamin, nestrupeno spojino, ki se iz telesa izloči z urinom.
English: There is no information available on success rates with other antidotes for cyanide poisoning, so it was not possible to carry out a comparison between the success rates seen with Cyanokit and with alternatives.
Slovenian: Ker ni podatkov o uspešnosti drugih protistrupov za zdravljenje zastrupitve s cianidom, ni bilo možno primerjati uspešnosti zdravila Cyanokit z drugimi protistrupi.
English: Cyanokit is used as an antidote to treat known or suspected poisoning with cyanide, a highly poisonous chemical.
Slovenian: Zdravilo Cyanokit je protistrup za zdravljenje znane zastrupitve s cianidom, zelo strupeno kemikalijo, ali v primeru suma nanjo.
English: A further 14 patients were studied whose cyanide poisoning was due to something other than smoke inhalation; most of these patients had taken cyanide during a suicide attempt.
Slovenian: Pri 14 bolnikih v študiji je do zastrupitve prišlo drugače kot zaradi vdihavanja dima; večina od teh bolnikov je cianid vzela med poskusom samomora.
English: There have been no studies directly comparing Cyanokit to any other treatment in humans.
Slovenian: Študij, ki bi neposredno primerjale učinkovitost zdravila Cyanokit s katerim koli drugim zdravilom, pri ljudeh ni bilo.
English: Why has Cyanokit been approved?
Slovenian: Zakaj je bilo zdravilo Cyanokit odobreno?
English: Cyanokit is a powder to be made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Cyanokit je prašek, ki se pripravi v raztopino za infundiranje (kapalno infuzijo) v veno.
English: The four who died had high blood levels of cyanide, and either their hearts had stopped or they had stopped breathing before receiving Cyanokit.
Slovenian: Štirje bolniki, ki niso preživeli, so imeli v krvi visoke ravni cianida oziroma je pri njih prišlo do zastoja srca ali dihanja pred prejemom zdravila Cyanokit.
English: For the full list of all side effects reported with Cyanokit, see the package leaflet.
Slovenian: Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Cyanokit, glejte navodilo za uporabo.
English: The frequency of the other side effects of Cyanokit cannot be estimated with the information currently available.
Slovenian: Na osnovi trenutno dostopnih podatkov ni možno oceniti pogostnosti drugih neželenih učinkov zdravila Cyanokit.
English: This makes it a useful option when cyanide poisoning is only suspected.
Slovenian: To je uporabno v primerih, ko gre samo za sum zastrupitve s cianidom.
English: How does Cyanokit work?
Slovenian: Kako zdravilo Cyanokit deluje?
English: How has Cyanokit been studied?
Slovenian: Kako je bilo zdravilo Cyanokit raziskano?
English: What is Cyanokit used for?
Slovenian: Za kaj se zdravilo Cyanokit uporablja?
English: What is Cyanokit?
Slovenian: Kaj je zdravilo Cyanokit?
English: How is Cyanokit used?
Slovenian: Kako se zdravilo Cyanokit uporablja?
English: The CHMP concluded that Cyanokit appeared to be a well-tolerated and efficient cyanide antidote, based on its effects on survival and the prevention of brain damage.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je glede na to, kako zdravilo vpliva na preživetje in na preprečevanje možganskih poškodb, sklenil, da so bolniki zdravilo Cyanokit dobro prenašali in da se je izkazalo kot učinkovit cianidni protistrup.
English: A sticker explaining this is supplied with every pack of Cyanokit.
Slovenian: Vsako pakiranje zdravila Cyanokit vsebuje nalepko, ki opisuje te učinke.
English: (see Annex I).
Slovenian: (Glej Prilogo I).
English: The CHMP took these comments into account.
Slovenian: Odbor CHMP je te pripombe upošteval.
English: The applicant presented literature search strategy.
Slovenian: Predlagatelj je predstavil strategijo iskanja po literaturi.
English: The reference Member State (RMS) is the United Kingdom and the concerned Member States (CMS) Austria (AT), Germany (DE), Croatia (HR), Ireland (IE), Luxembourg (LU), France (FR), Belgium (BE), Netherlands (NL), Portugal (PT) and Spain (ES).
Slovenian: Referenčna država članica je Združeno kraljestvo, zadevne države članice pa Avstrija (AT), Nemčija (DE), Hrvaška (HR), Irska (IE), Luksemburg (LU), Francija (FR), Belgija (BE), Nizozemska (NL), Portugalska (PT) in Španija (ES).
English: It is noted that there is significant use of opioid combinations in the EU.
Slovenian: Opozoriti je treba, da je uporaba opioidnih kombinacij v EU precejšnja.
English: The decentralised procedures UK/H/6034/001/DC, UK/H/6035/001/DC and UK/H/6176/001/DC started on 23 July 2015.
Slovenian: Decentralizirani postopki UK/H/6034/001/DC, UK/H/6035/001/DC in UK/H/6176/001/DC so se začeli 23. julija 2015.
English: Based on clinical data provided by the applicant, no new safety issues have been identified.
Slovenian: Na podlagi kliničnih podatkov, ki jih je predložil predlagatelj, ni bilo ugotovljenih novih varnostnih pomislekov.
English: As at the CMDh procedure no agreement could be reached the procedure was referred to the CHMP.
Slovenian: Ker v postopku skupine CMDh ni bilo mogoče doseči dogovora, so postopek napotili na odbor CHMP.
English: These risks are well known and are controlled by routine pharmacovigilance practices which CHMP has endorsed.
Slovenian: Ta tveganja so dobro znana in se nadzorujejo z rutinskimi farmakovigilančnimi praksami, ki jih je sprejel odbor CHMP.
English: All the risks associated with prolonged use have been identified as safety concerns in the current risk management plan.
Slovenian: Vsa tveganja, povezana z dolgotrajno uporabo, so bila v trenutnem načrtu za obvladovanje tveganja prepoznana kot varnostni pomisleki.
English: The applicant noted also the PSUR reports which cover over 89 million tablets of market use have not suggested any additional or unexpected risks.
Slovenian: Predlagatelj je tudi poudaril, da poročila PSUR, ki zajemajo več kot 89 milijonov tablet v tržni uporabi, niso pokazala dodatnih ali nepričakovanih tveganj.
English: It is worth noting that the indication being sought is for short term (3 days) exposure.
Slovenian: Poudariti je treba, da je predlagana indikacija namenjena kratkotrajni (3-dnevni) izpostavljenosti.
English: This medicinal product is already authorised during the first and second waves of the decentralised procedure as prescription only medicine in many EU countries.
Slovenian: To zdravilo je bilo že odobreno v prvem in drugem valu decentraliziranega postopka kot zdravilo na recept v številnih državah EU.
English: A risk management plan has been submitted in line with the above.
Slovenian: V skladu z navedenim je bil predložen načrt za obvladovanje tveganja.
English: More importantly this is consistent with the post marketing experience of the use of the combination both world-wide and in the countries within the EU.
Slovenian: Še pomembneje je, da je navedeno skladno z izkušnjami o uporabi kombinacije iz obdobja trženja po svetu in v državah EU.
English: Linear interpolation was use to estimate intermittent missing values.
Slovenian: Za oceno vmesnih manjkajočih vrednosti so uporabili linearno interpolacijo.
English: The PSURs would undoubtedly cover a range of ages and uses based upon real in market experience.
Slovenian: Poročila PSUR bi nedvomno zajela cel razpon starosti in uporab na podlagi dejanske tržne izkušnje.
English: The extensive post-marketing experience in countries outside EU indicates the potential for prolonged use is unlikely to materialise.
Slovenian: Obširne izkušnje iz obdobja trženja v državah zunaj EU kažejo, da je možnost za dolgotrajno uporabo skoraj neuresničljiva.
English: On 21 October 2016 the RMS United Kingdom therefore triggered a referral under Article 29(4) of Directive 2001/83/EC as these issues were considered to be a potential serious risk to public health.
Slovenian: Zato je referenčna država članica Združeno kraljestvo 21. oktobra 2016 sprožila napotitev v skladu s členom 29(4) Direktive 2001/83/ES, saj so bili ti pomisleki ocenjeni kot morebitno resno tveganje za javno zdravje.
English: The secondary analyses showed either no difference or in favour of the combination.
Slovenian: Sekundarne analize so pokazale bodisi odsotnost razlik bodisi prednost kombinacije.
English: Firstly, the two active substances in this fixed dose combination are supported by extensive published and regulatory evidence and history of efficacy and safety.
Slovenian: Prvič, zdravilni učinkovini v tej fiksni kombinaciji odmerkov sta podprti z obširnimi objavljenimi in regulativnimi dokazi ter zgodovino učinkovitosti in varnosti.
English: Major issues on efficacy and safety raised by several CMS remained unresolved and were considered as a potential serious risk to public health; hence the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 29(1) of Directive 2001/83/EC.
Slovenian: Pomembnejši pomisleki o učinkovitosti in varnosti več zadevnih držav članic so ostali nerešeni in so bili ocenjeni kot morebitno resno tveganje za javno zdravje, zato je bil postopek napoten na Skupino za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) v skladu s členom 29(1) Direktive 2001/83/ES.
English: Risk management
Slovenian: Obvladovanje tveganja
English: • The Committee considered the notification of the referral initiated by the United Kingdom under Article 29(4) of Directive 2001/83/EC on the basis that France, Germany, Spain and The Netherlands considered that the granting of the marketing authorisation would constitute a potential serious risk to public health.
Slovenian: • odbor je obravnaval obvestilo o napotitvi v skladu s členom 29(4) Direktive 2001/83/ES, ki jo je sprožilo Združeno kraljestvo, na podlagi dejstva, da so Francija, Nemčija, Španija in Nizozemska menile, da bi odobritev dovoljenja za promet z zdravilom pomenila morebitno resno tveganje za javno zdravje;
English: This is significant as there are growing concerns relating to the safety issues associated with opioids such as codeine when used in addition to paracetamol.
Slovenian: To je pomembno, saj obstaja čedalje več pomislekov v zvezi z varnostnimi vprašanji, povezanimi z opioidi, kot je kodein, ki se uporabljajo skupaj s paracetamolom.
English: As the proposed fixed dose combination is recommended to be used for no more than 3 days, the potential for prolonged use is largely mitigated.
Slovenian: Ker se priporoča, da se predlagana fiksna kombinacija odmerkov ne uporablja dlje kot 3 dni, je možnost dolgotrajne uporabe precej zmanjšana.
English: Ibuprofen is the safest of the NSAIDs and is therefore an optimal choice.
Slovenian: Ibuprofen je najvarnejše nesteroidno protivnetno zdravilo in je zato najboljša izbira.
English: Having considered all the data submitted by the applicant, the CHMP considered that the benefit-risk balance was adequately demonstrated.
Slovenian: Z upoštevanjem vseh podatkov, ki jih je predložil predlagatelj, je odbor CHMP ocenil, da je bilo razmerje med tveganji in koristmi ustrezno dokazano.
English: The CHMP assessed the available data and the additional supportive data from literature to support the use of this combination in the short term treatment of pain.
Slovenian: Odbor CHMP je ocenil razpoložljive podatke in dodatne podporne podatke iz literature v podporo uporabi te kombinacije pri kratkotrajnem zdravljenju bolečine.
English: The primary objective showed that the combination was statistically superior to the active substances individually.
Slovenian: Primarni cilj je pokazal, da je bila kombinacija statistično boljša od posamičnih učinkovin.
English: Therefore such a potential has virtually no impact on the benefit-risk status of the medicinal product.
Slovenian: Zato ta možnost dejansko nima vpliva na razmerje med tveganji in koristmi zdravila.
English: The use of the fixed combination will give time to both patients and physicians before an opioid containing product will be used.
Slovenian: Uporaba fiksne kombinacije bo bolnikom in zdravnikom zagotovila določen čas, preden bodo uporabili opioidno zdravilo.
English: The following main studies were submitted by the applicant in support of the marketing authorisation application.
Slovenian: Predlagatelj je v podporo vlogi za pridobitev dovoljenja za promet z zdravilom predložil naslednje glavne študije.
English: The results showed that the combination provided significantly greater pain relief than either mono-component (p<0.001).
Slovenian: Rezultati so pokazali, da je kombinacija bistveno bolj olajšala bolečino kot ena ali druga posamična komponenta (p < 0,001).
English: Furthermore, for this substance combination, there is no interference with their individual metabolic pathways, and they also act through different pharmacological pathways.
Slovenian: Nadalje pri tej kombinaciji učinkovin ne prihaja do oviranja presnovnih poti, učinkovini pa delujeta prek različnih farmakoloških poti.
English: In particular, the combination does not have the risks of abuse and misuse of opioids.
Slovenian: Pri kombinaciji predvsem ni tveganja za zlorabo in napačno uporabo, ki sta značilni za opioide.
English: Despite the non-systematic pain reporting of VAS assessments, the pain duration over which subjects assessed their pain was similar between the groups, thus enabling a standardised comparison.
Slovenian: Kljub nesistematičnemu poročanju o bolečini z ocenami po vizualni analogni lestvici je bil čas trajanja bolečine, v katerem so preiskovanci ocenjevali svojo bolečino, podoben med skupinami, kar je omogočilo standardizirano primerjavo.
English: The applicant noted that prolonged use exceeding the recommended three-day period may be only at the discretion and close supervision of a healthcare professional, who should ensure the rational and responsible use of the medicine and considered benefits versus risks and review the patient to assess for effect, side-effects and the need to continue.
Slovenian: Predlagatelj je poudaril, da je dolgotrajna uporaba, ki presega priporočeno tridnevno obdobje, mogoča samo po presoji in pod skrbnim nadzorom zdravstvenega delavca, ki mora zagotoviti razumno in odgovorno uporabo zdravila, upoštevati razmerje med tveganji in koristmi in oceniti bolnika glede učinka, neželenih učinkov in potrebe po nadaljnjem zdravljenju.
English: The fixed dose combination avoids the need to move to opioids with all their implications regarding safety and addiction risks.
Slovenian: Fiksna kombinacija odmerkov prepreči potrebo po prehodu na opioide, ki prinašajo tveganja v zvezi z varnostjo in odvisnostjo.
English: They all seem numerically similar to each other; however no formal comparison between the active substances was performed.
Slovenian: Številčno so si bile podobne, vendar formalne primerjave med zdravilnimi učinkovinami niso izvedli.
English: Rationale for use of the fixed dose combination ratio
Slovenian: Utemeljitev uporabe fiksne kombinacije odmerkov
English: The results showed that the means of time-adjusted SPIDs in placebo group (mean=6.63, SD=19.79) is significantly lower than either the one of Combination ¼ dose group (mean=19.25, SD=19.99), the Combination ½ dose group (mean=20.44, standard deviation (SD=20.78) or the Combination full dose group (mean=20.12, SD=18.01).
Slovenian: Rezultati so pokazali, da je povprečje časovno prilagojenih SPID v skupini s placebom (povprečje = 6,63, SD = 19,79) značilno nižje kot pri skupini, ki je prejemala kombinacijo z ¼ odmerka (povprečje = 19,25, SD = 19,99), kombinacijo z ½ odmerka (povprečje = 20,44, standardni odklon (SD) = 20,78) ali kombinacijo s polnim odmerkom (povprečje = 20,12, SD = 18,01).
English: For moderate pain, the benefits of the relatively small amount of ibuprofen were also not robustly shown.
Slovenian: Pri zmerni bolečini koristi sorazmerno majhne količine ibuprofena tudi niso bile robustno dokazane.
English: The CHMP noted the concerns by these members, but agreed that overall the efficacy of the combination for the short duration of use of 3 days has been demonstrated.
Slovenian: Odbor CHMP je upošteval pomisleke teh članic, vendar se je strinjal, da je bila skupna učinkovitost kombinacije za kratkotrajno, 3-dnevno uporabo dokazana.
English: The primary efficacy endpoint was the time-adjusted sum of pain intensity differences from baseline over a 48 hour period.
Slovenian: Primarni opazovani dogodek učinkovitosti je bila časovno prilagojena vsota razlik v intenzivnosti bolečine 48 ur od izhodišča.
English: Its objective was to compare timeadjusted Summed Pain Intensity Differences (SPIDs) from baseline of the Visual Analogue Pain (VAS) pain intensity scores up to 24 hours after the first dose of study medication among the four treatment groups to determine the form of the dose-response relationship.
Slovenian: Njen cilj je bil primerjati časovno prilagojene vsote razlik v intenzivnosti bolečine (Summed Pain Intensity Differences, SPID) po vizualni analogni lestvici bolečine od izhodišča do 24 ur po prvem odmerku študijskega zdravila med štirimi skupinami zdravljenja, da bi ugotovili obliko odnosa med odmerkom in odzivom.