FrancophonIA/ELRC3.0 huggingface dataset:
English: Call an ambulance
Danish: Ring efter en ambulance
English: The secondary packaging (actuator) is comprised of polypropylene and stainless steel.
Danish: Den sekundære emballage (aktuator) består af polypropylen og rustfrit stål.
English: The side effects below may happen with this medicine.
Danish: Nedenstående bivirkninger kan forekomme med dette lægemiddel.
English: There are no adequate data from the use of naloxone in pregnant women.
Danish: Der er utilstækkelige data fra anvendelse af naloxon til gravide kvinder.
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.
Danish: Nyxoid er ikke en erstatning for akut medicinsk behandling og kan bruges i stedet for intravenøs (iv) injektion, når iv-adgang ikke er øjeblikkelig tilgængelig.
English: Support the back of the neck and allow the head to tilt back.
Danish: Støt nakken og lad hovedet falde tilbage.
English: • Information about Nyxoid and the fact that it cannot replace provision of basic life support
Danish: • Information om Nyxoid og det faktum, at produktet ikke kan erstatte grundlæggende livreddende aktiviteter
English: Can you hear breathing sounds?
Danish: Kan du høre åndedrag?
English: • If you take opioids to control pain.
Danish: • Hvis du tager opioider for at behandle smerter.
English: ADRs are listed below by system organ class and frequency.
Danish: Bivirkningerne er angivet nedenfor i henhold til systemorganklasse og frekvens.
English: The Video should include:
Danish: Video skal inkludere:
English: Naloxone has not been shown to produce tolerance or cause physical or mental dependence.
Danish: Det er ikke påvist, at Naloxon fremkalder tolerance eller forårsager fysisk eller psykisk afhængighed.
English: Instructing patients / users on the proper use of Nyxoid
Danish: Instruktion af patienter/brugere i korrekt brug af Nyxoid
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
Danish: Frekvenskategorierne er tildelt til de bivirkninger, der betragtes som værende i hvert fald muligvis relateret til naloxon og defineres som meget almindelige: (≥ 1/10), almindelig: (≥ 1/100, < 1/10), ikke almindelig: (≥ 1/1.000, < 1/100), sjælden: (≥ 1/10.000, < 1/1.000) meget sjælden: (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: However, as naloxone is practically not orally bioavailable its potential to affect a breast-fed infant is negligible.
Danish: Da naloxon imidlertid praktisk talt ikke er oralt biotilgængeligt, er dets potentiale til at påvirke et ammende barn ubetydelig.
English: • Information on how to manage and monitor the patient until the emergency medical assistance arrives
Danish: • Information om, hvordan man behandler og overvåger patienten, indtil nødhjælp ankommer
English: Genotoxicity and carcinogenicity
Danish: Genotoksicitet og karcinogenicitet
English: Not better?
Danish: Ingen bedring?
English: Lay down.
Danish: Læg personen ned.
English: Watch for an improvement in the patient's breathing level, alertness and response to noise and touch.
Danish: Se efter en forbedring i patientens vejrtrækning, opmærksomhed og reaktion på støj og berøring.
English: Nyxoid should only be made available once the suitability and competence of an individual to administer naloxone in the appropriate circumstances has been established.
Danish: Nyxoid vil kun gøres tilgængelig, når en persons egnethed og kompetence, til at administrere naloxon under passende omstændigheder, er blevet etableret.
English: Onset of action following intranasal administration can reasonably be expected to occur in each individual before the tmax is reached.
Danish: Den indsættende virkning efter intranasal administration kan med rimelighed forventes at indtræde hos alle personer, inden tmax er nået.
English: Naloxone was not carcinogenic following oral administration in a rat 2-year study or in a 26-week study in Tg-rasH2 mice.
Danish: Naloxon var ikke karcinogen efter oral administration i et 2-årigt forsøg med rotter eller i et 26-ugers forsøg med Tg-rasH2 mus.
English: Detailed instructions on how to use Nyxoid are provided in the Package Leaflet and a Quick Start Guide is printed on the back of each blister.
Danish: Detaljerede anvisninger om, hvordan Nyxoid skal bruges, findes i pakkens indlægsseddel, og der er trykt en hurtig startvejledning bag på hver blister.
English: Do not prime or test before use.
Danish: Må ikke primes eller testes før brug.
English: Signs of overdose include:
Danish: Tegn på overdosis omfatter:
English: Patients who respond satisfactorily to Nyxoid must be closely monitored.
Danish: Patienter, som reagerer tilfredsstillende på Nyxoid, skal nøje overvåges.
English: The Patient Information Card should include:
Danish: Informationskortet til patienten skal inkludere:
English: Stay with the patient and continue to watch for an improvement until the emergency services arrive who will give further treatment.
Danish: Bliv hos patienten og fortsæt med at holde øje med en forbedring, indtil ambulancepersonalet kommer og giver yderligere behandling.
English: This can be done while the patient is in the recovery position.
Danish: Det kan gøres, mens patienten er i stabilt sideleje.
English: If the patient does not respond to two doses, further doses may be given (if available).
Danish: Hvis patienten ikke reagerer på de to doser, kan der gives flere doser (hvis tilgængelig).
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.
Danish: Inden Nyxoid lanceres i hver medlemsstat, skal indehaveren af markedsføringstilladelsen blive enig med de nationale kompetente myndigheder om indholdet og formatet af undervisningsmaterialerne, herunder kommunikationsmedier, modaliteter for distribution, og eventuelle andre aspekter af programmet.
English: Nyxoid may not fully reverse breathing problems.
Danish: Nyxoid afhjælper måske ikke fuldt ud vejrtrækningsproblemer.
English: Naloxone is therefore not teratogenic in rats or rabbits.
Danish: Naloxon er derfor ikke teratogent hos rotter eller kaniner.
English: Nyxoid will be supplied to you only after you or your carer have been taught how to use it.
Danish: Nyxoid vil først blive udleveret til dig, efter du eller din omsorgsperson har lært, hvordan det skal bruges.
English: Naloxone did not affect development or behaviour of surviving pups.
Danish: Naloxon påvirkede ikke udvikling eller adfærd hos de overlevende unger.
English: This may necessitate repeat doses of naloxone - though the need for repeat naloxone doses is dependent on the quantity, type and route of administration of the opioid agonist that is being treated.
Danish: Dette kan nødvendiggøre gentagne doser af naloxon - selv om behovet for gentagne naloxon doser afhænger af mængden, typen og administrationsformen af opioidagonisten, der behandles.
English: Emergency services may administer further doses according to local guidelines.
Danish: Ambulancepersonale/lægevagten kan administrere flere doser ifølge lokale retningslinjer.
English: If the patient responds to the first administration but then relapses again into respiratory depression, the second dose should be administered immediately.
Danish: Hvis patienten reagerer på den første dosis, men derefter falder tilbage til respirationsdepression, bør den anden dosis administreres øjeblikkeligt.
English: It reveals very high affinity for the opioid receptor sites and therefore displaces both opioid agonists and partial antagonists.
Danish: Det viser meget høj affinitet for opioidreceptorer og fortrænger derfor både opioidagonister og partielle antagonister.
English: Each spray contains only one dose.
Danish: Hver spray indeholder kun én dosis.
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.
Danish: Patienter eller andre personer, der kan tænkes at skulle administrere Nyxoid, skal instrueres i dets korrekte anvendelse og vigtigheden af at søge medicinsk hjælp.
English: • High blood pressure, low blood pressure
Danish: • Højt blodtryk, lavt blodtryk
English: Instructions for giving Nyxoid nasal spray: Check for symptoms and response.
Danish: Vejledning i at give Nyxoid næsespray: Tjek for symptomer og reaktioner.
English: 1 mg, 30 (8, 60) minutes for 2 mg and 15 (10, 60) minutes for 4 mg intranasal doses.
Danish: var 15 (10, 60) minutter for 1 mg, 30 (8, 60) minutter for 2 mg, og 15 (10, 60) minutter for 4 mg for intranasale doser.
English: Pharmacotherapeutic group: Antidotes, ATC code: V03AB15
Danish: Farmakoterapeutisk klassifikation: Antidoter, ATC-kode: V03 AB15
English: Do not prime or test the Nyxoid nasal spray before use as it contains only one dose of naloxone and cannot be reused.
Danish: Du må ikke klargøre eller afprøve Nyxoid-næsesprayen før brug, da den kun indeholder én dosis naloxon og ikke kan genbruges.
English: Overall, the weight of evidence indicates that naloxone poses minimal, if any, risk for human genotoxicity and carcinogenicity.
Danish: Generelt tyder evidensvægten på, at naloxon udgør en minimal risiko, eller slet ingen risiko, for genotoksicitet og karcinogenicitet hos mennesker.
English: Training will be provided on how to use Nyxoid before it is supplied to you.
Danish: Du vil blive oplært i, hvordan du bruger Nyxoid, før det udleveres til dig.
English: However, reversal of respiratory depression caused by buprenorphine is limited.
Danish: Reversering af respirationsdepression, forårsaget af buprenorphin, er imidlertid begrænset.
English: Press firmly on the plunger until it clicks to give the dose.
Danish: Tryk hårdt ned på stemplet, indtil det klikker, for at afgive dosis.
English: • Emphasis on the need to make an immediate emergency call for an ambulance
Danish: • Fremhævelse af behovet for straks at ringe efter nødhjælp
English: Q4 2022
Danish: 4. kvartal 2022
English: Clear away anything blocking their nose.
Danish: Fjern alt, som tilstopper næsen.
English: • Information on placing the patient into recovery position and administering the second dose, if required, in this position
Danish: • Information om, hvordan man anbringer patienten i stabilt sideleje og administrerer den anden dosis i denne stilling, hvis det er nødvendigt.
English: Naloxone had no effect on fertility and reproduction in the rat or on early embryonic development of the rat and rabbit.
Danish: Naloxon havde ingen virkning på fertilitet og reproduktion hos rotter eller den tidlige embryoudvikling hos rotter og kaniner.
English: If this happens, a second dose can be given immediately.
Danish: Hvis det sker, kan du give en ny dosis med det samme.
English: Spray into one nostril.
Danish: Spray i det ene næsebor.
English: Reversal of buprenorphine-induced respiratory depression may be incomplete.
Danish: Reversion af buprenorfin-induceret respiratorisk depression kan være ufuldstændig.
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.
Danish: Hjerte-kar-bivirkninger er opstået hyppigere hos postoperative patienter med en forudeksisterende hjerte-kar-sygdom eller hos dem, der modtager andre lægemidler, som producerer lignende hjerte-karbivirkninger.
English: • A brief introduction on Nyxoid
Danish: • En kort introduktion af Nyxoid
English: Can you feel breath on the cheek?
Danish: Kan du mærke ånde på din kind?
English: If the patient does not respond, the second dose should be administered after 2-3 minutes.
Danish: Hvis patienten ikke reagerer, bør den anden dosis administreres efter 2-3 minutter.
English: It is unknown whether naloxone is excreted in human breast milk and it has not been established whether infants who are breast-fed are affected by naloxone.
Danish: Det vides ikke, om naloxon udskilles i human mælk, og det er ikke klarlagt, om spædbørn, der ammes, påvirkes af naloxon.
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.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du får udleveret dette lægemiddel.
English: • Identification of signs of suspected opioid overdose, especially respiratory depression and information on how to check the airways and breathing
Danish: • Identifikation af tegn på en formodet opioidoverdosis, særligt respirationsdepression og information om, hvordan man tjekker luftveje og vejrtrækning
English: Naloxone is rapidly metabolized in the liver and excreted in the urine.
Danish: Naloxon metaboliseres hurtigt i leveren og udskilles i urinen.
English: For overdose of opioids (such as heroin)
Danish: Til opioidoverdosis (som f.eks. heroin)
English: If you are at risk of an opioid overdose you should always carry your Nyxoid with you.
Danish: Hvis du har risiko for at få en opioidoverdosis, skal du altid have Nyxoid på dig.
English: Intranasal administration of naloxone has demonstrated naloxone to be rapidly absorbed, as evidenced by very early appearance (as early as 1 minute after administration) of the active substance in systemic circulation.
Danish: Naloxon absorberes hurtigt ved intranasal administration, hvilket ses ved meget tidlig forekomst (så tidligt som 1 minut efter indgivelse) af det aktive stof i det systemiske kredsløb.
English: Caution should be exercised when naloxone is administered to a breast-feeding mother but there is no need to discontinue breast-feeding.
Danish: Der skal udvises forsigtighed, når naloxon administreres til en ammende kvinde, men det er ikke nødvendigt at afbryde amning.
English: If you are given Nyxoid while you are pregnant or breast-feeding, your baby should be closely monitored.
Danish: Hvis du får Nyxoid, mens du er gravid eller ammer, skal din baby overvåges nøje.
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.
Danish: Anbring patienten i stabilt sideleje på siden med åben mund ned mod jorden og bliv hos vedkommende, indtil ambulancepersonalet ankommer.
English: It undergoes extensive hepatic metabolism mainly by glucuronide conjugation.
Danish: Det gennemgår omfattende metabolisme i leveren, fortrinsvis ved glucuronidkonjugation.
English: How Nyxoid is to be given
Danish: Sådan skal Nyxoid gives
English: Adults and adolescents aged 14 years and over
Danish: Voksne og unge i alderen 14 år og derover
English: There are no data available on the excretion of naloxone following intranasal administration, however, the disposition of labelled naloxone following IV administration was studied in healthy volunteers and opioid-dependent patients.
Danish: Der foreligger ingen data vedrørende udskillelse af naloxon efter intranasal administration, men fordelingen af mærket naloxon efter intravenøs administration blev undersøgt på raske frivillige og opioidafhængige patienter.
English: The principal metabolites are naloxone-3-glucuronide, 6-beta-naloxol and its glucuronide.
Danish: Hovedmetabolitterne er naloxon-3-glucuronid, 6-beta-naloxol og dets glucuronid.
English: If an overdose is suspected Nyxoid should be given.
Danish: Hvis der er mistanke om en overdosis, skal der gives Nyxoid.
English: Single-dose nasal spray for overdose of opioids (such as heroin) Do not test before use
Danish: Enkeltdosis næsespray til overdosis af opioider (som f.eks. heroin) Må ikke testes før brug
English: • Awareness of possible important risks such as opioid withdrawal symptoms and recurrence of respiratory depression
Danish: • Viden om potentielle risici, såsom opioidabstinenssymptomer og tilbagevenden af respirationsdepression
English: A study demonstrated mean absolute bioavailability of 47% and mean half-lives of 1.4 h from intranasal doses of 2 mg.
Danish: Et studie påviste gennemsnitlig absolut biotilgængelighed på 0,4 % og gennemsnitlige halveringstider på 1,4 timer fra intranasale doser på 2 mg.
English: Naloxone, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively at opioid receptors.
Danish: Naloxon, et semisyntetisk morfinderivat (N-allyl-nor-oxymorphone), er en specifik opioidantagonist, som virker kompetitivt ved opioidreceptorer.
English: The safety and efficacy of Nyxoid in children below 14 years has not been established.
Danish: Sikkerheden og virkningen af Nyxoid hos børn under 14 år er ikke klarlagt.
English: You may get strong withdrawal symptoms with this medicine (see later in section 4 of this leaflet under ‘Conditions to look out for')
Danish: Denne medicin kan give stærke abstinenssymptomer (se senere i punkt 4 i denne indlægsseddel under ”Forhold, du skal være opmærksom på”)
English: If this happens, further doses may be given after 2 to 3 minutes using a new nasal spray.
Danish: Hvis dette sker, kan der gives flere doser efter 2-3 minutter ved brug af en ny næsespray.
English: If you are allergic to naloxone or any of the other ingredients of this medicine (listed in section 6).
Danish: hvis du er allergisk over for naloxon eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt
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.
Danish: Det menes, at denne virkning er et resultat af den bueformede dosisresponskurve af buprenorphin med faldende smertelindring i tilfælde af høje doser.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INTRANASAL SPRAY/DEVICE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER INTRANASAL SPRAY/ANORDNINGS MÆRKAT
English: Tilt head back.
Danish: Vip hovedet tilbage.
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.
Danish: Efter 72 timer blev 65 % af den injicerede dosis udskilt i urinen hos raske frivillige sammenlignet med 68 % af dosen hos opiatafhængige patienter.
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.
Danish: Opioidabstinenser kan være livstruende hos nyfødte, hvis de ikke opdages og behandles korrekt, og kan omfatte følgende tegn og symptomer: krampeanfald, usædvanlig kraftig gråd og hyperaktive reflekser.
English: If the patient is no better within 2-3 minutes, a second dose can be given.
Danish: Hvis patienten ikke får det bedre i løbet af 2-3 minutter, kan der gives en ny dosis.
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).
Danish: • Hvis du er fysisk afhængig af opioider, eller hvis du får høje doser af opioider (f.eks. heroin, metadon, fentanyl, oxycodon, buprenorphin eller morfin).
English: Further doses (if available) should be administered in alternate nostrils and the patient should be monitored whilst awaiting arrival of the emergency services.
Danish: Yderligere doser (hvis tilgængelige) bør administreres i næseborene på skift, og patienten bør overvåges, mens der ventes på ambulance/lægevagt.
English: Check for signs of overdose, such as: no response to touch or sounds, slow uneven breathing or no breathing, snoring, gasping or gulping, blue or purple fingernails or lips.
Danish: Tjek for tegn på overdosis som f.eks.: Ingen reaktion på berøring eller lyde, langsom, uregelmæssig vejrtrækning eller ingen vejrtrækning, snorken, gispen eller slubren, blå eller violette fingernegle eller læber.
English: Behavioural changes including violent behaviour, nervousness and excitement may also be observed.
Danish: Der kan desuden ses adfærdsændringer, som inkluderer voldelig adfærd, nervøsitet og opstemthed.
English: Do not use this medicine after the expiry date which is stated on the carton, blister pack and the label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen, blisterpakningen og etiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In the absence of opioids or agonistic effects of other opioid antagonists, it exhibits essentially no pharmacologic activity.
Danish: Hvis der ikke er opioider eller agonistiske virkninger af andre opioidantagonister til stede, udviser det stort set ingen farmakologisk aktivitet.
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.
Danish: Efter at have taget dette lægemiddel må du ikke føre motorkøretøj, betjene maskiner eller udføre nogen fysisk eller psykisk krævende aktivitet i mindst 24 timer, da opioidernes virkning kan vende tilbage.
English: Naloxone elicits a pharmacological response due to the interaction with opioids and opioid agonists.
Danish: Naloxon fremkalder en farmakologisk reaktion på grund af interaktionen med opioider og opioidagonister.
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).
Danish: I peri-postnatale rotteforsøg forårsagede naloxon øget mortalitet hos rotteunger i den umiddelbare port-partum periode ved de høje doser, der også medførte markant maternel toksicitet (f.eks. vægttab, krampeanfald).
English: The signs and symptoms of an opioid overdose can return after this nasal spray is given.
Danish: Tegn og symptomer på opioidoverdosis kan vende tilbage, efter at denne næsespray er givet.
English: Your baby could suffer from sudden opioid withdrawal syndrome, which could be life-threatening if not treated.
Danish: Dit barn kan lide af pludseligt opioidabstinenssyndrom, hvilket kan være livstruende, hvis det ikke behandles.
English: The following adverse reactions have been reported with Nyxoid and/or other naloxone-containing medicinal products during clinical studies and post marketing experience.
Danish: Følgende bivirkninger er blevet indberettet for Nyxoid og/eller andre naloxonholdige lægemiddelprodukter i kliniske forsøg og efter markedsføring.
English: • Build-up of fluid in the lungs
Danish: • Ophobning af væske i lungerne
English: Acute withdrawal symptoms occur uncommonly (may affect up to 1 in 100 people).
Danish: Akutte abstinenssymptomer opstår med frekvensen ikke almindelig (kan forekomme hos op til 1 ud af 100 personer).
English: • Information on how to use the nasal spray to correctly administer Nyxoid
Danish: • Information hvordan man bruger næsesprayen korrekt til administration af Nyxoid
English: Studies in animals have shown reproductive toxicity only at maternally toxic doses (see section 5.3).
Danish: Dyreforsøg har kun vist reproduktionstoksicitet ved maternelle toksiske doser (se pkt.
English: Hypersensitivity, Anaphylactic shock
Danish: Overfølsomhed, anafylaktisk shock
English: Nyxoid works for a short time only to reverse the effects of opioids while you wait for emergency medical attention.
Danish: Nyxoid virker kun i kort tid og ophæver virkningen af opioider, mens du venter på akut behandling.
English: This medicine contains the active substance naloxone.
Danish: Dette lægemiddel indeholder det aktive stof naloxon.