FrancophonIA/ELRC3.0 huggingface dataset:
English: Zona Industrial da Abrunheira Edifício 10 - Sintra Business Park 2710-089 Sintra Portugal
Croatian: Zona Industrial da Abrunheira Edifício 10 - Sintra Business Park 2710-089 Sintra
English: Baxter MédicoFarmacêutica, Lda.
Croatian: Baxter Médico-Farmacêutica, Lda.
English: Pouet de Camilo, 2 46394 Ribarroja del Turia (Valencia) Spain
Croatian: 46394 Ribarroja del Turia (Valencia)
English: Norfolk IP24 3SE United Kingdom
Croatian: Norfolk IP24 3SE
English: United Kingdom Baxter Healthcare Limited
Croatian: Ujedinjeno Kraljevstvo Baxter Healthcare Limited Caxton Way
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Numeta G13%E and Numeta G16%E emulsions for infusion
Croatian: Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, nositelj(a) odobrenja u državama članicama
English: Baxter Deutschland GmbH
Croatian: Baxter Deutschland GmbH Edisonstr.
English: Karla Engliše 3201/6
Croatian: BAXTER CZECH spol. s r.o. Karla Engliše 3201/6
English: Poligono Industrial Sector 14
Croatian: Poligono Industrial Sector 14 Pouet de Camilo, 2
English: 00144 ROMA Italy
Croatian: Piazzale dell' Industria, 20 00144 ROMA
English: MUMETA G16%E, emulsión para perfusión
Croatian: NUMETA G16%E, emulsión para perfusión
English: MUMETA G13%E, emulsión para perfusión
Croatian: NUMETA G13%E, emulsión para perfusión
English: NUMETAH G13%E, émulsion pour perfusion
Croatian: G13%E, émulsion pour perfusion
English: Numeta G 16 % E Emulsion zur Infusio
Croatian: NUMETA G16%E emulsie voor infusie
English: Luxembourg Baxter S.A. Bd Rene Branquart, 80 7860 Lessines
Croatian: Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15 1020 Wien
English: You may need one or two infusions.
Croatian: Možda ćete trebati jednu ili dvije infuzije.
English: 12-16 hours
Croatian: 12-16 sati
English: Date of first authorisation: 23 November 2007 Date of latest renewal: 20 July 2012
Croatian: Datum prvog odobrenja: 23. studenog 2007. Datum posljednje obnove: 20. srpnja 2012.
English: It depends on how serious the poisoning is.
Croatian: Ovisi o tome koliko je ozbiljno trovanje.
English: The survival rate of 41% depended very much on the clinical situation.
Croatian: Stopa preživljavanja od 41% znatno je ovisila o kliničkoj situaciji.
English: • altered mental status
Croatian: • izmijenjeni mentalni status
English: Results may vary considerably from one analyser to another, therefore, caution is required when reporting and interpreting laboratory results.
Croatian: Rezultati mogu znatno varirati od jednog analizatora do drugog pa je stoga potreban oprez kod prijavljivanja i tumačenja laboratorijskih rezultata.
English: Tell your doctor immediately if you have the following symptoms during or after this treatment:
Croatian: Odmah obavijestite svog liječnika ako imate sljedeće simptome tijekom ili nakon ovog liječenja:
English: This red colouration has no other consequences on your body.
Croatian: Crveno obojenje mokraće nema drugih posljedica za Vaše tijelo.
English: Body weight in kg
Croatian: Tjelesna težina u kg
English: Artificially increased*
Croatian: Umjetno povećani*
English: Documentation on efficacy is available for 54 paediatric patients.
Croatian: Dokumentirani podaci o djelotvornosti dostupni su za 54 pedijatrijska bolesnika.
English: Repeat this procedure if necessary with the second vial.
Croatian: Ako je potrebno, ponovite ovaj postupak s drugom bočicom.
English: Read all of this leaflet carefully before using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: This leaflet was last revised in MM/YYYY.
Croatian: Ova uputa je zadnji puta revidirana u MM/GGG.
English: 24 hours with the exception of bilirubin (up to 4 days)
Croatian: 24 sata uz iznimku bilirubina (do 4 dana)
English: • exposure to fire smoke in an enclosed area
Croatian: • izlaganje dimu vatre u zatvorenom području
English: Initial dose in g in mL
Croatian: Početna doza u g u mL
English: Caution is required in the interpretation of urinary colorimetric tests for as long as chromaturia is present.
Croatian: Potreban je oprez u interpretaciji urinarnih kolorimetrijskih testova, dok god je prisutna kromaturija.
English: Avenue Louise 480 1050 Brussels Belgium
Croatian: Avenue Louise 480 1050 Brussels Belgija
English: Cyanide is a highly poisonous chemical.
Croatian: Cijanid je jako otrovna kemikalija.
English: However, because of the limitations of the available data, it is not possible to apply frequency estimations:
Croatian: Međutim, zbog ograničenja dostupnih podataka, nije moguće primijeniti procjene učestalosti:
English: The liver and kidney were found to be the major target organs.
Croatian: Nađeno je da su jetra i bubrezi glavni ciljni organi.
English: Tell your doctor or other health care professional if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili drugog zdravstvenog djelatnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: No interference observed
Croatian: Nisu primijećene interferencije
English: Duration of interference after a 5 g dose
Croatian: Trajanje interferencije nakon doze od 5 g
English: No special hazard for humans was identified based on conventional studies of single and repeated dose toxicity and genotoxicity.
Croatian: Nije identificiran poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti jednokratnih i ponovljenih doza i genotoksičnosti.
English: Such side effects may be serious and need immediate attention.
Croatian: Te nuspojave mogu biti ozbiljne i zahtijevati neodgodivu pozornost.
English: • problems with memory
Croatian: • problemi s pamćenjem
English: It can be administered during pregnancy and breast-feeding.
Croatian: Može se primijeniti tijekom trudnoće i dojenja.
English: If overdose occurs, treatment is directed to the management of symptoms.
Croatian: U slučaju predoziranja, liječenje je usmjereno na liječenje simptoma.
English: • that you have been treated with Cyanokit if you need to have the following: - any blood or urine tests.
Croatian: • Da ste bili liječeni Cyanokitom ako trebate sljedeće: - bilo koji test krvi ili mokraće.
English: • changes in the results of blood tests for certain white blood cells (lymphocytes)
Croatian: • promjene u rezultatima testiranja krvi za određene tipove bijelih krvnih stanica (limfocita)
English: The effects on these tests typically last 48 hours after a 5 g dose, but may persist for longer periods.
Croatian: Učinci na te testove tipično traju 48 sati nakon doze od 5 g, ali mogu potrajati i dulje vrijeme.
English: If these temporary conditions have been exceeded, the product should be discarded.
Croatian: Ako su ovi privremeni uvjeti prekoračeni, lijek se mora baciti.
English: * ≥ 10% interference observed on at least one analyser ** Artificially decreased using the diazo method *** Inconsistent results
Croatian: * ≥ 10% interferencije primijećeno na najmanje jednom analizatoru ** Umjetno snižen primjenom diazo metode *** Nedosljedni rezultati
English: No dose adjustment is required in these patients.
Croatian: Kod tih bolesnika nije potrebna prilagodba doze.
English: • swelling around the eyes, lips, tongue, throat or hands
Croatian: • oticanje oko očiju, usana, jezika, grla ili ruku
English: However findings were only seen at exposure levels considered being higher than the maximum human exposure, indicating limited relevance to clinical use.
Croatian: Međutim, nalazi su primijećeni samo pri razinama izloženosti koje se smatraju višim od najviše izloženosti za ljude što ukazuje na ograničenu vrijednost za kliničku primjenu.
English: One short catheter for administration to children.
Croatian: Jedan kratki kateter za primjenu kod djece.
English: The dose of 150 mg/kg approximately corresponds to the maximum recommended human dose.
Croatian: Doza od 150 mg/kg odgovara približno najvišoj preporučenoj dozi za ljude.
English: • inflammation in the part of the body where the medicine was infused.
Croatian: • upala dijela tijela na kojem je ubrizgavan lijek.
English: Increase in blood pressure
Croatian: Porast krvnog tlaka
English: These may last for several weeks, and affect mainly the face and the neck.
Croatian: To stanje može trajati nekoliko tjedana i zahvaća uglavnom lice i vrat.
English: Interference following a 10 g dose can be expected to last up to an additional 24 hours.
Croatian: Interferencija nakon primjene doze od 10 g može se očekivati da traje dodatnih 24 sata.
English: Gastrointestinal (digestive) problems
Croatian: Probavni (digestivni) problemi
English: Ventricular extrasystoles.
Croatian: Ventrikularne ekstrasistole.
English: Two transfer devices.
Croatian: Dva uređaja za prijenos.
English: The rate of intravenous infusion for the second dose ranges from 15 minutes (for patients extremely unstable) to 2 hours based on patient condition.
Croatian: Brzina intravenske infuzije za drugu dozu varira od 15 minuta (za iznimno nestabilne bolesnike) do 2 sata, ovisno o stanju bolesnika.
English: In some situations, hemodialysis was required to achieve recovery (see section 4.8).
Croatian: U nekim je situacijama bila potrebna hemodijaliza kako bi se postigao oporavak (vidjeti dio 4.8).
English: Tell your doctor or other health care professional
Croatian: Obavijestite svog liječnika ili drugog zdravstvenog djelatnika
English: Your doctor or health care professional will give you Cyanokit by infusion into a vein.
Croatian: Vaš liječnik ili zdravstveni djelatnik dat će Vam Cyanokit infuzijom u venu.
English: Haemodialysis may be effective in such a circumstance, but is only indicated in the event of significant hydroxocobalamin-related toxicity.
Croatian: Hemodijaliza može biti učinkovita u takvim okolnostima, ali je indicirana samo u slučaju značajne toksičnosti povezane s hidroksokobalaminom.
English: There are no adequate data from the use of hydroxocobalamin in pregnant women and the potential risk for humans is unknown.
Croatian: Nema odgovarajućih podataka o primjeni hidroksokobalamina kod trudnica i potencijalni rizik za ljude nije poznat.
English: Limited data on children (0 to 18 years old) treated with hydroxocobalamin did not show any difference in the safety profile of hydroxocobalamin between adults and children.
Croatian: Ograničeni podaci kod djece (u dobi od 0 do 18 godina) liječene hidroksokobalaminom nisu pokazali nikakvu razliku u sigurnosnom profilu hidroksokobalamina između odraslih i djece.
English: The majority of the urinary excretion occurred during the first 24 hours, but red coloured urine was observed for up to 35 days following the intravenous infusion.
Croatian: Većina izlučivanja urinom dogodila se tijekom prva 24 sata, ali crvena boja urina zadržala se i do 35 dana nakon intravenske infuzije.
English: Interference with laboratory tests
Croatian: Interferencije s laboratorijskim testovima
English: No data are available on male and female fertility as well as on peri- and postnatal development.
Croatian: Nisu dostupni podaci o muškoj i ženskoj plodnosti kao ni oni za perinatalni i postnatalni razvoj.
English: The presence and extent of cyanide poisoning are often initially unknown.
Croatian: Prisutnost i stupanj trovanja cijanidom u početku su često nepoznati.
English: • if you are allergic to hydroxocobalamin or vitamin B12.
Croatian: • Ako ste alergični na hidroksokobalamin ili vitamin B12.
English: Cyanokit may lead to shut down of haemodialysis machines until it is eliminated from the blood (at least 5.5 to 6.5 days).
Croatian: Cyanokit može uzrokovati prekid rada uređaja za dijalizu dok se ne ukloni iz krvi (tijekom najmanje 5,5 do 6,5 dana).
English: Overall, the total urinary excretion was calculated to be at least 60 to 70% of the administered dose.
Croatian: Ukupno gledano, izračunato je da se urinom izlučilo 60 do 70% primijenjene doze.
English: 40 avenue George V 75008 Paris France
Croatian: 40 Avenue George V 75008 Paris Francuska
English: Of the 89 patients who died, 63 were initially found in cardiac arrest, suggesting that many of these patients had almost certainly suffered irreparable brain injury prior to administration of hydroxocobalamin.
Croatian: Od 89 bolesnika koji su umrli, otkriveno je da su njih 63 imali srčani arest što ukazuje na to da su mnogi od tih bolesnika gotovo zasigurno pretrpjeli nepopravljiva oštećenja na mozgu prije primjene hidroksokobalamina.
English: Consideration must be given to decontamination measures based on the route of exposure.
Croatian: Nužno je razmotriti mjere dekontaminacije na temelju puta izlaganja.
English: • coloured plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters.
Croatian: • obojena plazma koja može uzrokovati umjetno povišenje ili sniženje razina određenih laboratorijskih parametara.
English: The relevance of this finding to humans is unlikely since it was not reported in short-term studies conducted with hydroxocobalamin.
Croatian: Važnost ovog nalaza za ljude nije vjerojatna jer ovaj događaj nije prijavljen u kratkoročnim ispitivanjima provedenim s hidroksokobalaminom.
English: Animal studies have shown teratogenic effects following daily exposure throughout organogenesis (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su teratogene učinke nakon dnevne izloženosti tijekom organogeneze (vidjeti dio 5.3).
English: However, taken into account: - that no more than two injections of hydroxocobalamin are to be administered, - the potentially life threatening condition, - the lack of alternative treatment, hydroxocobalamin may be given to a pregnant woman.
Croatian: Ipak uzeti u obzir: - da se ne smiju primijeniti više od dvije injekcije hidroksokobalamina, - potencijalno po život opasno stanje, - nedostatak alternativnog liječenja, hidroksokobalamin se može dati trudnici.
English: • symptoms such as headache or dizziness, as they may be due to a rise in blood pressure.
Croatian: • simptomi poput glavobolje ili omaglice mogu biti uzrokovani porastom krvnog tlaka.
English: • soot present around mouth, nose and/or oropharynx
Croatian: • čađa prisutna oko usta, nosa ili orofarinksa
English: Cyanokit may modify the results of these tests.
Croatian: Cyanokit može izmijeniti rezultate tih testova. - procjene opeklina.
English: For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of
Croatian: U svrhu ambulantne primjene, Cyanokit se može izložiti promjenama temperature tijekom kraćih razdoblja
English: Doses as high as 15 g have been administered without reported specific dose related adverse reactions.
Croatian: Visoke doze od 15 mg bile su primjenjene bez prijavljenih specifičnih nuspojava povezanih s dozom.
English: Hydroxocobalamin may interfere with all urine colorimetric parameters.
Croatian: Hidroksokobalamin može interferirati sa svim kolorimetrijskim parametrima urina.
English: In case of known pregnancy at the time of treatment with Cyanokit or in case that pregnancy becomes known after treatment with Cyanokit, health care professionals are requested to promptly report the exposure during pregnancy to the Marketing Authorisation Holder and/or Health Authorities and to carefully follow-up on the pregnancy and its outcome.
Croatian: U slučaju potvrđene trudnoće u vrijeme liječenja lijekom Cyanokit ili u slučaju da se trudnoća potvrdi nakon liječenja lijekom Cyanokit, zdravstveni djelatnici moraju odmah prijaviti izloženost tijekom trudnoće nositelju odobrenja i/ili nadležnim zdravstvenim institucijama i pomno nadzirati trudnoću i njen ishod.
English: Pustular rashes, which may last for several weeks, affecting mainly the face and the neck.
Croatian: Pustularni osip koji može trajati i nekoliko tjedana, a zahvaća uglavnom lice i vrat.
English: What Cyanokit is and what it is used for
Croatian: Što je Cyanokit i za što se koristi
English: Cyanokit does not substitute oxygen therapy and must not delay the set up of the above measures.
Croatian: Cyanokit ne nadoknađuje terapiju kisikom i ne smije odgoditi prethodno navedene mjere.
English: No studies on fertility have been performed (see section 5.3).
Croatian: Nisu provedena ispitivanja plodnosti (vidjeti dio 5.3).
English: Centre de Production de Semoy 2, rue du Pressoir Vert F-45400 Semoy France
Croatian: Centre de Production de Semoy 2, rue du Pressoir Vert F-45400 Semoy Francuska
English: However, skin lesions, oedema, and pain are highly suggestive of burns.
Croatian: No, kožne lezije, edemi i bol snažno ukazuju na opekline.
English: The maximal increase in blood pressure has been observed toward the end of infusion (see section 4.8).
Croatian: Maksimalni porast krvnog tlaka opažen je pri kraju infuzije (vidjeti dio 4.8).
English: • a feeling of tightness in the throat
Croatian: • osjećaj stezanja u grlu
English: • breathing difficulties, hoarseness, difficulty in speaking
Croatian: • poteškoće pri disanju, promuklost, teškoće pri govoru
English: This rise in blood pressure especially occurs at the end of having this treatment and usually settles down within several hours
Croatian: Porast krvnog tlaka javlja se posebice na kraju liječenja i obično se povuče unutar nekoliko sati nakon liječenja ovim lijekom
English: Depending upon the severity of the poisoning and the clinical response (see section 4.4), a second dose may be administered.
Croatian: Ovisno o težini trovanja i kliničkom odgovoru (vidjeti dio 4.4) može biti potrebno primijeniti drugu dozu.
English: For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of usual transport (15 days submitted to temperatures ranging from 5°C to 40°C), transport in the desert (4 days submitted to temperatures ranging from 5°C to 60°C) and freezing/defrosting cycles (15 days submitted to temperatures ranging from -20°C to 40°C).
Croatian: U svrhu ambulantne primjene Cyanokit se može izložiti tijekom kraćih razdoblja promjenama temperature pri uobičajenom transportu (15 dana izložen rasponu temperatura od 5 °C do 40 °C), transportu u pustinji (4 dana izložen temperaturama u rasponu od 5 °C do 60 °C) i ciklusima smrzavanja/odmrzavanja (15 dana izložen temperaturnim rasponima od -20 °C do 40 °C).
English: Adults: The maximum total recommended dose is 10 g.
Croatian: Odrasli: Ukupna najviša preporučena doza je 10 g.
English: The presence of altered mental status (confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning.
Croatian: Prisutnost izmijenjenog mentalnog statusa (konfuzija i dezorijentacija) i/ili midrijaza ukazuju na stvarno trovanje cijanidom.
English: Dose-proportional pharmacokinetics were observed following single dose intravenous administration of 2.5 to 10 g of Cyanokit in healthy volunteers.
Croatian: Farmakokinetika proporcionalna dozi primijećena je nakon primjene jednokratne intravenske doze lijeka od 2,5 do 10 g lijeka Cyanokit kod zdravih dobrovoljaca.
English: There is no widely available, rapid, confirmatory cyanide blood test.
Croatian: Nije široko dostupno brzo potvrdno testiranje krvi na prisutnost cijanida.
English: Furthermore, in 34 patients with known cyanide concentrations above the lethal threshold (≥ 100 µmol/L), 21 (62%) survived following treatment with hydroxocobalamin.
Croatian: Nadalje, u 34 bolesnika s poznatom koncentracijom cijanida iznad smrtonosnog praga (≥ 100 µmol/l), 21 (62%) bolesnik je preživio nakon liječenja hidroksokobalaminom.
English: Consequently, these and other medicinal products must not be administered simultaneously through the same intravenous line as hydroxocobalamin.
Croatian: Posljedično, ti i drugi lijekovi ne smiju se primjenjivati istodobno kroz istu intravensku liniju kao i hidroksokobalamin.
English: “To be attached to the patient's medical record:
Croatian: „Mora se priložiti u bolesnikov zdravstveni karton:
English: In this setting hypotension and/or a plasma lactate concentration ≥ 10 mmol/L (higher than the one mentioned under signs and symptoms due to the fact that carbon monoxide contributes to lactic acidaemia) are highly suggestive of cyanide poisoning.
Croatian: U ovom okruženju hipotenzija i/ili koncentracije laktata u plazmi ≥ 10 mmol/l (više od onih navedenih u znakovima i simptomima zbog činjenice da ugljični monoksid pridonosi laktičkoj acidemiji) izrazito ukazuju na trovanje cijanidima.
English: Read the leaflet for storage conditions in ambulatory use
Croatian: Pročitajte Uputu o lijeku za uvjete čuvanja u ambulantnoj primjeni
English: In general, the effectiveness of hydroxocobalamin in these patients was similar to that of younger patients.
Croatian: Općenito je učinkovitost hidroksokobalamina kod tih bolesnika bila slična onoj kod mlađih bolesnika.
English: Before Cyanokit is administered, it is recommended to check affected persons for the presence of the following:
Croatian: Prije primjene Cyanokita, preporučuje se provjeriti unesrećenu osobu na prisutnost sljedećeg:
English: Not all smoke inhalation victims necessarily will have cyanide poisoning, but may present with burns, trauma, and exposure to additional toxic substances aggravating the clinical picture.
Croatian: Ne moraju sve žrtve udisanja dima imati nužno i trovanje cijanidom, ali mogu imati opekline, traumu i biti izloženi dodatnim toksičnim tvarima koje pogoršavaju kliničku sliku.
English: If there is clinical suspicion of cyanide poisoning, it is strongly recommended that Cyanokit be administered without delay.
Croatian: Ako postoji klinička sumnja na trovanje cijanidom, snažno se preporučuje da se Cyanokit primijeni bez odgode.
English: The remaining 102 subjects were healthy volunteers who had not been exposed to cyanide at the time of hydroxocobalamin administration.
Croatian: Preostala 102 ispitanika bili su zdravi dobrovoljci koji nisu bili izloženi cijanidu u vrijeme primjene hidroksokobalamina.
English: Where neurological assessment over time was possible, (96 patients of the 171 patients who presented with neurological symptoms prior to hydroxocobalamin administration), 51 (53%) patients receiving hydroxocobalamin showed improvement or a complete restoration.
Croatian: Kad je nakon nekog vremena bila moguća neurološka procjena, (96 bolesnika od njih 171 koji su imali neurološke simptome prije primjene hidroksokobalamina), 51 (53%) bolesnik koji je primao hidroksokobalamin pokazao je poboljšanje ili potpuni oporavak.
English: As physical and chemical incompatibilities were observed with a number of selected medicinal products that are frequently used in resuscitation efforts, these and other medicinal products must not be administered simultaneously in the same intravenous line as hydroxocobalamin.
Croatian: S obzirom na to da su primijećene fizikalne i kemijske inkompatibilnosti s brojnim odabranim lijekovima koji se često koriste prilikom oživljavanja, ti i drugi lijekovi ne smiju se primjenjivati istodobno u istoj intravenskoj liniji kao i hidroksokobalamin.
English: What Cyanokit is and what it is used for What you need to know before Cyanokit is used How Cyanokit is used
Croatian: Što je Cyanokit i za što se koristi Što morate znati prije nego počnete primjenjivati Cyanokit Kako primjenjivati Cyanokit
English: What Cyanokit looks like and contents of the pack
Croatian: Kako Cyanokit izgleda i sadržaj pakiranja
English: This medicine is an emergency treatment.
Croatian: Ovaj lijek se primjenjuje u hitnim slučajevima.
English: While determination of blood cyanide concentration is not required and must not delay treatment with hydroxocobalamin, it may be useful for documenting cyanide poisoning.
Croatian: Dok određivanje koncentracije cijanida u krvi nije potrebno te ne smije odgoditi liječenje hidroksokobalaminom, može biti korisno za dokumentiranje trovanja cijanidom.