FrancophonIA/ELRC3.0 huggingface dataset:
English: Lay the patient on their back.
Croatian: Polegnite bolesnika na leđa.
English: Can you hear breathing sounds?
Croatian: Čujete li zvuk disanja?
English: Emergency services may administer further doses according to local guidelines.
Croatian: Hitne službe mogu dati dodatne doze u skladu s lokalnim smjernicama.
English: In some cases, further doses may be necessary.
Croatian: U nekim slučajevima mogu biti potrebne dodatne doze.
English: 3832 RC Leusden Netherlands
Croatian: 3832 RC Leusden Nizozemska
English: This can be done while the patient is in the recovery position.
Croatian: To se može obaviti dok je bolesnik u bočnom položaju.
English: Tell your doctor if you experience any of these symptoms.
Croatian: Obavijestite liječnika ako dobijete bilo koji od ovih simptoma.
English: • A list of the educational material included in the training program
Croatian: • Popis edukacijskog materijala uključenog u program za obuku
English: This should be performed in accordance with the educational guidance for Nyxoid.
Croatian: To je potrebno provesti u skladu s edukacijskom smjernicom za Nyxoid.
English: • If you take opioids to control pain.
Croatian: • ako uzimate opioide za kontrolu boli.
English: After 2-3 mins, use 2nd spray.
Croatian: Nakon 2-3 minute, upotrijebiti 2. sprej.
English: • Increased skin sensitivity
Croatian: • povećanu osjetljivost kože
English: What Nyxoid is and what it is used for
Croatian: Što je Nyxoid i za što se koristi
English: Like all medicines, this medicine can cause side effects although not everyone gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Nyxoid is intended for use by appropriately trained individuals.
Croatian: Nyxoid je predviđen za upotrebu od strane odgovarajuće obučenih osoba.
English: • not responding to a loud noise or touch.
Croatian: • nereagiranje na glasan zvuk ili dodir.
English: Check airways and breathing.
Croatian: Provjerite dišne puteve i disanje.
English: Medis Hungary Kft
Croatian: Magyarország Medis Hungary Kft
English: Nyxoid should be administered as soon as possible to avoid damage to the central nervous system or death.
Croatian: Nyxoid treba dati što je brže moguće kako bi se izbjeglo oštećenje središnjeg živčanog sustava ili smrt.
English: • Information about Nyxoid and the fact that it cannot replace provision of basic life support
Croatian: • Informaciju o Nyxoidu i činjenicu da on ne može zamijeniti pružanje osnovnih mjera održavanja života
English: Check with your doctor, pharmacist or nurse if you are not sure.
Croatian: Provjerite s liječnikom,ljekarnikom ili medicinskom sestrom ako niste sigurni.
English: If you are at risk of an opioid overdose you should always carry your Nyxoid with you.
Croatian: Ako kod Vas postoji rizik od predoziranja opioidima, trebate uvijek nositi Nyxoid sa sobom.
English: Call an ambulance
Croatian: Pozovite hitnu pomoć
English: Call for an ambulance.
Croatian: Zovite hitnu pomoć.
English: Other medicines and Nyxoid
Croatian: Drugi lijekovi i Nyxoid
English: Lay in recovery position.
Croatian: Poleći u bočni položaj.
English: • Sweating
Croatian: • Znojenje
English: If the patient does not respond to two doses, further doses may be given (if available).
Croatian: Ako bolesnik ne reagira na dvije doze, mogu se dati dodatne doze (ako su raspoložive).
English: For 10 seconds check for breathing - is the chest moving?
Croatian: Provjerite disanje tijekom 10 sekundi - pomiču li se prsa?
English: The Video should include:
Croatian: Video treba sadržavati:
English: If this happens, a second dose can be given immediately.
Croatian: Ako dođe do toga, druga doza može se dati odmah.
English: For overdose of opioids (such as heroin)
Croatian: Za predoziranje opioidima (kao što je heroin)
English: Tell your doctor if you have damage to the inside of your nose as this could affect how Nyxoid works.
Croatian: Recite liječniku ako imate oštećenje unutarnjeg dijela nosa jer bi to moglo utjecati na djelovanje
English: In view of the indication and the broad therapeutic margin, overdose is not to be expected.
Croatian: U svjetlu indikacija i široke terapijske granice, ne očekuje se predoziranje.
English: The secondary packaging (actuator) is comprised of polypropylene and stainless steel.
Croatian: Sekundarni spremnik (aktivator) sastoji se od polipropilena i nehrđajućeg čelika.
English: • High blood pressure, low blood pressure
Croatian: • Visoki krvni tlak, niski krvni tlak
English: • If you use buprenorphine.
Croatian: • ako primjenjujete buprenorfin.
English: Contents of the pack and other information What Nyxoid contains
Croatian: Sadržaj pakiranja i druge informacije Što Nyxoid sadrži
English: • Emergency services should be called if an opioid overdose is suspected.
Croatian: • Hitna medicinska služba treba se pozvati ako se sumnja na predoziranje opioidima.
English: Each spray contains only one dose.
Croatian: Svaki sprej sadrži samo jednu dozu.
English: Support the back of the neck and allow the head to tilt back.
Croatian: Napravite potporu stražnjem dijelu vrata i omogućite da se glava zabaci unatrag.
English: Frequency categories are assigned to those adverse reactions considered to be at least possibly causally related to naloxone and are defined as very common: (≥ 1/10); common: (≥ 1/100, < 1/10); uncommon: (≥ 1/1,000, < 1/100); rare: (≥ 1/10,000, < 1/1,000) very rare: (< 1/10,000); not known
Croatian: Kategorije učestalosti dodijeljene su onim nuspojavama za koje se smatra da su bile barem moguće uzročno povezane s naloksonom i definirane su kao vrlo često: (≥ 1/10); često: (≥ 1/100, < 1/10); manje često: (≥ 1/1000, < 1/100); rijetko: (≥ 1/10 000, < 1/1000) vrlo rijetko: (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Nyxoid should not be used during pregnancy unless the clinical condition of the woman requires treatment with naloxone.
Croatian: Nyxoid se ne smije koristiti tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje naloksonom.
English: • Information on how to manage and monitor the patient until the emergency medical assistance arrives
Croatian: • Informaciju o tome kako postupati i nadzirati bolesnika dok ne dođe služba hitne medicinske pomoći
English: • Emphasis on the need to make an immediate emergency call for an ambulance
Croatian: • Naglasak na potrebu žurnog poziva službi za hitnu medicinsku pomoć
English: In patients who are unconscious and not breathing normally additional life-saving support should be given if possible.
Croatian: Bolesnicima koji su u nesvijesti i koji ne dišu normalno, potrebno je pružiti dodatne mjere spašavanja i održavanja života ako je moguće.
English: Genotoxicity and carcinogenicity
Croatian: Genotoksičnost i kancerogenost
English: In addition, training is provided via a video and a Patient Information Card.
Croatian: Osim toga, omogućena je obuka putem video prikaza i kartice s informacijama za bolesnika.
English: If an incomplete response occurs, respiration should be mechanically assisted.
Croatian: Ako je odgovor nepotpun, potrebno je primijeniti mehanički potpomognuto disanje.
English: Watch for an improvement in the patient's breathing level, alertness and response to noise and touch.
Croatian: Pazite na poboljšanje bolesnikove razine disanja, budnosti i odgovora na zvuk i dodir.
English: If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving a supply of this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego Vam propišu i izdaju ovaj lijek.
English: Naloxone is therefore not teratogenic in rats or rabbits.
Croatian: Nalokson stoga nije teratogen za štakore ili zečeve.
English: Monitoring of the patient for a response
Croatian: Nadzor bolesnika u vezi odgovora na lijek
English: Press firmly on the plunger until it clicks to give the dose.
Croatian: Čvrsto pritisnite klip dok se ne čuje klik kako bi dali dozu.
English: Nyxoid will be supplied to you only after you or your carer have been taught how to use it.
Croatian: Nyxoid će Vam biti propisan i izdan tek nakon što ste Vi ili Vaš njegovatelj upućeni kako da ga koristite.
English: Frequency, type and severity of adverse reactions in adolescents are expected to be the same as in adults.
Croatian: Očekuje se da će učestalost, vrsta i težina nuspojava u adolescenata biti jednaka kao i u odraslih.
English: The Patient Information Card should include:
Croatian: Kartica s informacijama za bolesnika treba sadržavati:
English: What Nyxoid looks like and contents of the pack
Croatian: Kako Nyxoid izgleda i sadržaj pakiranja
English: You may get strong withdrawal symptoms with this medicine (see later in section 4 of this leaflet under ‘Conditions to look out for')
Croatian: Mogu Vam se pojaviti snažni simptomi ustezanja uz ovaj lijek (vidjeti dalje u dijelu 4 ove upute pod „Stanja na koja treba obratiti pozornost”)
English: There are no adequate data from the use of naloxone in pregnant women.
Croatian: Nema odgovarajućih podataka o upotrebi naloksona kod trudnih žena.
English: Pharmacotherapeutic group: Antidotes, ATC code: V03AB15
Croatian: Farmakoterapijska skupina: Antidoti, ATK oznaka: V03AB15
English: • Allergic reactions such as swelling of the face, mouth, lips or throat, allergic shock
Croatian: • Alergijske reakcije kao što su oticanje lica, usta, usana ili grla, alergijski šok
English: In peri-post natal rat studies, naloxone produced increased pup deaths in the immediate post-partum period at the high doses that also caused significant maternal toxicity in rats (e.g. bodyweight loss, convulsions).
Croatian: U peri-post natalnim ispitivanjima na štakorima, nalokson je uzrokovao povećanu smrtnost mladunaca u razdoblju neposredno nakon poroda pri visokim dozama koje su također uzrokovale značajnu toksičnost u majke kod štakora (npr. gubitak tjelesne težine, konvulzije).
English: Studies in animals have shown reproductive toxicity only at maternally toxic doses (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost samo u dozama koje su toksične za majku (vidjeti dio 5.3).
English: It is thought that this effect is a result of the arch-shaped dose-response curve of buprenorphine with decreasing analgesia in the event of high doses.
Croatian: Smatra se da je taj učinak posljedica krivulje odgovora na dozu buprenorfina u obliku luka, sa smanjiivanjem analgezije u slučaju visokih doza.
English: Adverse cardiovascular effects have occurred more frequently in postoperative patients with a pre-existing cardiovascular disease or in those receiving other medicines that produce similar adverse cardiovascular effects.
Croatian: Kardiovaskularne nuspojave pojavile su se češće kod postoperativnih bolesnika s postojećom kardiovaskularnom bolesti ili kod onih koji primaju druge lijekove koji proizvode slične kardiovaskularne nuspojave.
English: However, as naloxone is practically not orally bioavailable its potential to affect a breast-fed infant is negligible.
Croatian: Međutim, budući da nalokson praktički nije oralno bioraspoloživ, njegov potencijal utjecaja na dojenče je zanemariv.
English: • Identification of signs of suspected opioid overdose, especially respiratory depression and information on how to check the airways and breathing
Croatian: • Identifikaciju znakova sumnje na predoziranje opioidima, naročito respiratorne depresije i informacije o tome kako provjeriti dišne puteve i disanje
English: Naloxone has not been shown to produce tolerance or cause physical or mental dependence.
Croatian: Nalokson nije pokazao razvoj tolerancije ili uzrokovanje fizičke ili psihičke ovisnosti.
English: • Awareness of possible important risks such as opioid withdrawal symptoms and recurrence of respiratory depression
Croatian: • Svijest o mogućim važnim rizicima kao što su simptomi sindroma ustezanja i ponavljanje respiratorne depresije
English: Further doses (if available) should be administered in alternate nostrils and the patient should be monitored whilst awaiting arrival of the emergency services.
Croatian: Daljne doze (ako su dostupne) treba davati u različite nosnice, a bolesnika treba nadzirati do dolaska hitne službe.
English: Immune system disorders Very rare:
Croatian: Poremećaji imunološkog sustava Vrlo rijetko:
English: Behavioural changes including violent behaviour, nervousness and excitement may also be observed.
Croatian: Također se mogu uočiti promjene u ponašanju, uključujući nasilna ponašanja, nervozu i uzbuđenje.
English: It undergoes extensive hepatic metabolism mainly by glucuronide conjugation.
Croatian: Prolazi opsežan jetreni metabolizam, prvenstveno konjugacijom glukoronida.
English: Nyxoid is not a substitute for emergency medical care and may be used instead of intravenous (IV) injection, when IV access is not immediately available.
Croatian: Nyxoid nije zamjena za hitnu medicinsku pomoć i može se korisiti umjesto intravenske (i.v.) injekcije, kada i.v. pristup nije odmah moguć.
English: Prior to launch of Nyxoid in each Member State the Marketing Authorisation Holder must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka u promet u svakoj zemlji članici Europske unije, nositelj odobrenja (MAH) će s nacionalnim nadležnim tijelom dogovoriti konačni sadržaj i format edukacijskog materijala, uključujući medij za komunikaciju i načine distribucije kao i svaki drugi aspekt programa.
English: In the absence of opioids or agonistic effects of other opioid antagonists, it exhibits essentially no pharmacologic activity.
Croatian: U nedostatku opioida ili agonističkog učinka drugih opioidnih agonista, u suštini ne pokazuje farmakološku aktivnost.
English: Opioid withdrawal may be life-threatening in neonates if not recognised and properly treated and may include the following signs and symptoms: convulsions, excessive crying and hyperactive reflexes.
Croatian: Ustezanje opioida može biti opasno po život kod novorođenčadi ako se ne prepozna i pravilno ne liječi i može uključiti sljedeće znakove i simptome: konvulzije, pretjerani plač i hiperaktivne reflekse
English: • Build-up of fluid in the lungs
Croatian: • Nakupljanje tekućine u plućima
English: Nyxoid contains only one dose and therefore it must not be primed or tested prior to administration.
Croatian: Nyxoid sadrži samo jednu dozu, zato se ne smije za primjenu pripremati potiskivanjem niti isprobavati prije primjene.
English: A study demonstrated mean absolute bioavailability of 47% and mean half-lives of 1.4 h from intranasal doses of 2 mg.
Croatian: Ispitivanje je pokazalo srednju apsolutnu bioraspoloživost od 47% i srednji poluvijek od 1,4 h za intranazalne doze od 2 mg.
English: Place the patient into the recovery position on their side with mouth open pointing towards the ground and stay with the patient until the emergency services arrive.
Croatian: Položite bolesnika u bočni položaj s ustima otvorenim u pravcu poda i ostanite uz bolesnika dok ne stigne hitna pomoć.
English: Nyxoid may not fully reverse breathing problems.
Croatian: Nyxoid možda neće u dovesti do potpunog povlačenja problema s disanjem.
English: Your baby could suffer from sudden opioid withdrawal syndrome, which could be life-threatening if not treated.
Croatian: Vaše dijete bi moglo patiti od iznenadnog sindroma ustezanja opioida, koji mogu biti opasni po život ako se ne liječe.
English: If the patient responds to the first administration but then relapses again into respiratory depression, the second dose should be administered immediately.
Croatian: Ako bolesnik reagira na prvo davanje lijeka, no nakon toga dođe do relapsira respiratorne depresije, drugu dozu treba dati odmah.
English: Nyxoid is packed in a carton containing 2 nasal sprays individually sealed in blisters.
Croatian: Nyxoid je pakiran u kutiji koja sadrži 2 spreja za nos pojedinačno pakirana u blistere.
English: Naloxone was not carcinogenic following oral administration in a rat 2-year study or in a 26-week study in Tg-rasH2 mice.
Croatian: Nalokson nije bio kancerogen nakon oralne primjene u štakora u dvogodišnjem ispitivanju ili 26-tjednom ispitivanju kod Tg-rasH2 miševa.
English: Mundipharma Polska Sp. z o.o.
Croatian: Polska Mundipharma Polska Sp. z o.o.
English: Onset of action following intranasal administration can reasonably be expected to occur in each individual before the tmax is reached.
Croatian: Početak djelovanja nakon intranazalne primjene može se razložno očekivati kod svakog pojedinca prije nego je dosegnut tmax.
English: Below is a step by step guide.
Croatian: nastavku se nalazi vodič u kojem je primjena opisana korak po korak.
English: Clear away anything blocking their nose.
Croatian: Ukloniti sve što uzrokuje začepljenje nosa.
English: After taking this medicine, you must not drive, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours, since the effects of opioids may recur.
Croatian: Nakon uzimanja ovog lijeka, ne smijete upravljati vozilima, raditi sa strojevima ili poduzeti neku drugu fizičku ili psihičku zahtjevnu aktivnost najmanje 24 sata jer se učinak opioida može vratiti.
English: Nyxoid works for a short time only to reverse the effects of opioids while you wait for emergency medical attention.
Croatian: Nyxoid djeluje kratkotrajno samo za poništavanje učinaka opioida dok čekate hitnu medicinsku pomoć.
English: If you are given Nyxoid while you are pregnant or breast-feeding, your baby should be closely monitored.
Croatian: Ako ste primili Nyxoid tijekom trudnoće ili dojenja, Vaše dijete treba pomno nadzirati.
English: • Being sick (vomiting)
Croatian: • Mučnina (povraćanje)
English: Spray into one nostril.
Croatian: Raspršiti sprej u jednu nosnicu.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: Acute withdrawal symptoms occur uncommonly (may affect up to 1 in 100 people).
Croatian: Simptomi aktunog ustezanja događaju se manje često (mogu se javiti u do 1 na 10 osoba).
English: • If you are physically dependent on opioids or if you have received high doses of opioids (for example heroin, methadone, fentanyl, oxycodone, buprenorphine or morphine).
Croatian: • ako ste fizički ovisni o opioidima ili ako ste primili visoke doze opioida (npr. heroin, metadon, fentanil, oksikodon, buprenorfin ili morfij).
English: Stay with the patient and continue to watch for an improvement until the emergency services arrive who will give further treatment.
Croatian: Ostanite s bolesnikom i nastavite pratiti oporavak do dolaska hitne pomoći koja će pružiti daljnje liječenje.
English: Do not prime or test the Nyxoid nasal spray before use as it contains only one dose of naloxone and cannot be reused.
Croatian: Nemojte pripremati za primjenu potiskivanjem ili isprobavati sprej za nos prije upotrebe jer sadrži samo jednu dozu naloksona i ne može se ponovno koristiti.
English: The appropriate maximum dose of Nyxoid is situation specific.
Croatian: Odgovarajuća maksimalna doza Nyxoida ovisi o situaciji.
English: However, reversal of respiratory depression caused by buprenorphine is limited.
Croatian: Međutim, poništavanje respiratorne depresije uzrokovane buprenorfinom je ograničeno.
English: Overall, the weight of evidence indicates that naloxone poses minimal, if any, risk for human genotoxicity and carcinogenicity.
Croatian: Sveukupno uzevši, težina dokaza pokazuje da nalokson posjeduje minimalni rizik za genotoksičnost i karcinogenost u ljudi, ako ga uopće ima.
English: The principal metabolites are naloxone-3-glucuronide, 6-beta-naloxol and its glucuronide.
Croatian: Glavni metaboliti su nalokson-3-glukuronid, 6-beta-naloksol i njegovi glukuronidi.
English: Patients who respond satisfactorily to Nyxoid must be closely monitored.
Croatian: Bolesnici sa zadovoljavajućim odgovorom na Nyxoid moraju se pažljivo pratiti.
English: If the patient is no better within 2-3 minutes, a second dose can be given.
Croatian: Ako se bolesnik ne osjeća bolje unutar 2 - 3 minute, može se dati druga doza.
English: Naloxone was not mutagenic in the bacterial reverse mutation assay, but was positive in mouse lymphoma assay and was clastogenic in vitro, however, naloxone was not clastogenic in vivo.
Croatian: Nalokson nije bio mutagen u bakterijskim testovima reverzne mutacije, ali je bio pozitivan u testovima mišjih limfoma i bio je klastogen in vitro, međutim, nalokson nije bio klastogen in vivo.
English: Do not use this medicine after the expiry date which is stated on the carton, blister pack and the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru i naljepnici iza oznake EXP.
English: Naloxone did not affect development or behaviour of surviving pups.
Croatian: Nalokson nije utjecao na razvoj ili ponašanje preživjelih mladunaca.
English: After a period of 72 hours, 65% of the injected dose was recovered in urine in the healthy volunteers compared with 68% of the dose in opiate-dependent patients.
Croatian: Nakon 72 sata, 65 % injiciranedoze nađeno je u mokraći kod zdravih dobrovoljaca u usporedbi s 68 % doze kod bolesnika ovisnih o opioidima.
English: Hypersensitivity, Anaphylactic shock
Croatian: Preosjetljivost, anafilaktički šok
English: Breast-fed babies from mothers who have been treated with Nyxoid should be monitored to check for sedation or irritability.
Croatian: Dojenčad dojenu mlijekom majki liječenih Nyxoidom treba pratiti zbog provjere prisutnosti sedacije ili razdražljivosti.
English: In reports on intravenous/intramuscular naloxone: hypotension, hypertension, cardiac arrhythmia (including ventricular tachycardia and fibrillation) and pulmonary oedema have occurred with the postoperative use of naloxone.
Croatian: U prijavama za intravenski/intramuskularni nalokson: hipotenzija, hipertenzija, srčana aritmija (uključujući ventrikularnu tahikardiju i fibrilaciju) i plućni edem pojavili su se s postoperativnom primjenom naloksona.
English: Give Nyxoid in the other nostril using a new Nyxoid nasal spray.
Croatian: Dajte Nyxoid u drugu nosnicu koristeći novi Nyxoid sprej za nos.
English: The safety and efficacy of Nyxoid in children below 14 years has not been established.
Croatian: Sigurnost i djelotvornost Nyxoida u djece u dobi mlađoj od 14 nije još ustanovljena.
English: Mundipharma A/S
Croatian: Danmark Mundipharma A/S
English: Patients or any other person who might be in a position to administer Nyxoid must be instructed in its proper use and the importance of seeking medical assistance.
Croatian: Bolesnici ili druge osobe koje mogu biti u poziciji da primijene Nyxoid moraju biti obučeni za pravilnu primjenu i upućeni o važnosti traženja liječničke pomoći.
English: Naloxone is rapidly metabolized in the liver and excreted in the urine.
Croatian: Nalokson se brzo metabolizira u jetri i izlučuje u urin.
English: Therefore, the prescriber should take appropriate steps to ensure that the patient and/or any other person who might be in a position to administer Nyxoid thoroughly understands the indications and use of Nyxoid.
Croatian: Stoga osoba koja propisuje lijek treba poduzeti odgovarajuće mjere kako bi zajamčila da bolesnici i/ili bilo koje druge osobe koje mogu biti u poziciji da daju Nyxoid temeljito poznaju indikacije i uporabu Nyxoida.
English: • Fast heart rate, high blood pressure
Croatian: • ubrzan puls, visok krvni tlak
English: Hold the nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.
Croatian: Držite sprej za nos palcem na dnu klipa, a kažiprstom i srednjim prstom pridržavajte sa svake strane mlaznice.