FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Hvis du har flere spørgsmål vedrørende brugen af dette lægemiddel, kan du spørge din læge eller apotekspersonalet.
English: Patients who are receiving opioids for the relief of chronic pain may experience pain and opioid withdrawal symptoms when Nyxoid is administered.
Danish: Patienter, som får opioider til afhjælpning af kroniske smerter, kan opleve smerter og opioidabstinenssymptomer, når Nyxoid administreres.
English: The most common adverse drug reaction (ADR) seen with naloxone administration is nausea (frequency very common).
Danish: Den mest almindelige bivirkning, der ses ved administration af naloxon, er kvalme (frekvens meget almindelig).
English: Nyxoid is packed in a carton containing 2 nasal sprays individually sealed in blisters.
Danish: Nyxoid er pakket i en æske med 2 næsespray, der er individuelt indpakket i blister.
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.
Danish: Hold næsesprayen med din tommelfinger nedenunder stemplet og din pege- og langfinger på hver side af dysen.
English: In pregnant women who have been treated with Nyxoid, the fetus should be monitored for signs of distress.
Danish: Hos gravide kvinder, som er blevet behandlet med Nyxoid, bør fostret overvåges for tegn på føtal distress.
English: • Steps detailing management of a patient which are aligned with information in PIC and package leaflet
Danish: • Detaljerede trin til behandling af en patient, som svarer til informationen i PIC'en og indlægssedlen
English: • Details of what information needs to be shared when training the patient/carer o how to manage a known or suspected opioid overdosed and how to properly administer Nyxoid o how to minimise the occurrence and severity of the following risks associated with Nyxoid: reappearance of respiratory depression, precipitation of acute opioid withdrawal effect and lack of efficacy due to medication error
Danish: • Detaljerede oplysninger om den information, der skal formidles ved træning af patienten/plejeren o Hvordan de skal behandle en kendt eller formodet overdosering af opioider og korrekt administration af Nyxoid o Hvordan de kan minimere forekomsten og sværhedsgraden af de følgende risici forbundet med Nyxoid: tilbagevenden af respirationsdepression, fremskyndelse af akut opioidabstinenssyndrom, og manglende effekt på grund af medicineringsfejl.
English: The immediate container consists of a type I glass vial with siliconised chlorobutyl stopper containing 0.1 ml solution.
Danish: Den umiddelbare beholder består af et type-I hætteglas med silikonebehandlet chlorbutylprop med 0,1 ml opløsning.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Following an IV dose of 125 µg, 38% of the dose was recovered in the urine within 6 hours in healthy volunteers compared with 25% of the dose being recovered in opioid-dependent patients in the same time period.
Danish: Efter en intravenøs dosis på 125 μg var 38 % af dosis udskilt i urinen indenfor 6 timer hos raske frivillige sammenlignet med 25 % af dosis udskilt hos opioidafhængige patienter i samme tidsrum.
English: What you need to know before you receive Nyxoid Do not use Nyxoid
Danish: Det skal du vide, før du får Nyxoid Brug ikke Nyxoid:
English: Give Nyxoid in the other nostril using a new Nyxoid nasal spray.
Danish: Giv Nyxoid i det andet næsebor med en ny Nyxoid næsespray.
English: Nyxoid is a nasal spray used for the emergency treatment of opioid overdose or possible opioid overdose in adults and adolescents over 14 years.
Danish: Nyxoid er en næsespray, der anvendes til livreddende behandling af opioidoverdosis eller mulig opioidoverdosis hos voksne og unge over 14 år.
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.
Danish: I rapporter om intravenøs/intramuskulær naloxon: Hypotension, hypertension, dysrytmi (herunder ventrikulær takykardi og flimren) og lungeødem er forekommet ved postoperativ brug af naloxon.
English: • Allergic reactions such as swelling of the face, mouth, lips or throat, allergic shock
Danish: • Allergiske reaktioner som f.eks. hævelser i ansigtet, munden, læberne eller halsen, anafylaktisk shock
English: Naloxone does not possess the "agonistic" or morphine-like properties characteristic of other opioid antagonists.
Danish: Naloxon besidder ikke de “agonistiske” eller morfinlignende egenskaber, der er karakteristiske for andre opioidantagonister.
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.
Danish: Den ordinerende læge bør derfor tage passende forholdsregler for at sikre, at patienten og/eller en anden hjælper, som kan være i stand til at administrere Nyxoid, forstår indikationerne for og brugen af Nyxoid.
English: Patients who have received naloxone to reverse the effects of opioids should be warned not to drive, to operate machinery or to engage in other activities demanding physical or mental exertion for at least 24 hours, since the effect of the opioids may return.
Danish: Patienter, som har fået naloxon for at ophæve virkningen af opioider, skal advares om ikke at føre motorkøretøj, betjene maskiner eller udføre andre aktiviteter, som er fysisk eller mentalt krævende, i mindst 24 timer, da virkningen af opioiderne kan vende tilbage.
English: • The patient/carer information card
Danish: • Informationskortet til patienten/plejeren
English: The MAH shall ensure that in each MS where Nyxoid is marketed, all relevant health care professionals (HCP) who are expected to prescribe and/or supply Nyxoid are provided with:
Danish: Indehaveren af markedsføringstilladelsen skal sikre sig, i hver medlemsstat, hvor Nyxoid markedsføres, at alle relevante sundhedsprofessionelle, som ventes at ordinere og/eller udlevere Nyxoid har fået:
English: • Fast heart rate, high blood pressure
Danish: • Hurtig puls, højt blodtryk
English: When administering naloxone to patients who have received buprenorphine as an analgesic, complete analgesia may be restored.
Danish: Når naloxon administreres til patienter, som har fået buprenorphin som smertestillende middel, kan fuldstændig smertelindring genoprettes.
English: • Reference to the QSG on the back of the product immediate packaging
Danish: • Henvisning til lynvejledningen bag på produktets indre emballage
English: Clear the mouth and nose of any blockages.
Danish: Sørg for, at munden og næsen ikke er blokeret.
English: Naloxone temporarily reverses the effects of opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine and morphine.
Danish: Naloxon ophæver midlertidigt virkningen af opioider, som f.eks. heroin, metadon, fentanyl, oxycodon, buprenorphin og morfin.
English: Breast-fed babies from mothers who have been treated with Nyxoid should be monitored to check for sedation or irritability.
Danish: Ammende børn fra mødre, som er blevet behandlet med Nyxoid, bør overvåges for at kontrollere for bedøvelse eller irritabilitet.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR OR BATCHFRIGIVELSE
English: After 2-3 mins, use 2nd spray.
Danish: Efter 2-3 minutter, bruges en ny spray.
English: • Instructions that the HCP has to provide the patient/carer with the PIC and to make sure that the patients/carers will have access to the video (either through the PIC or memory stick) and are encouraged to read the quick starting guide (QSG) and package leaflet included in the medicinal product outer carton.
Danish: • Instruktioner om, at sundhedsprofessionelle skal give patienten/plejeren PIC'en og sikre sig, at patienter/plejere har adgang til videoen (enten gennem PIC'en eller hukommelseskortet), og at de opfordres til at læse lynvejledningen og indlægssedlen vedlagt i produktets karton.
English: Lay in recovery position.
Danish: Læg i stabilt sideleje.
English: The effect of some opioids can be longer than the effect of naloxone, which could lead to reoccurrence of respiratory depression and therefore further doses of naloxone may be required.
Danish: Virkningen af nogle opioider kan vare længere end virkningen af naloxon, hvilket kan medføre, at den respiratoriske depression vender tilbage, og der kan derfor være behov for yderligere doser naloxon.
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.
Danish: Naloxon var ikke mutagent i de bakterielle tilbagemutationstest, men var positivt i muselymfomtest og var klastogent in vitro.
English: CAMBRIDGE, CB4 0GW,
Danish: CAMBRIDGE, CB4 0GW, Storbritannien
English: Intranasal absorption and efficacy of naloxone can be altered in patients with damaged nasal mucosa and septal defects.
Danish: Intranasal absorption og virkningen af naloxon kan ændres hos patienter med beskadiget næseslimhinder og septumdefekter.
English: Pregnancy, breastfeeding and fertility
Danish: Graviditet, amning og fertilitet
English: • Emergency services should be called if an opioid overdose is suspected.
Danish: • Ring straks efter en ambulance, hvis der er mistanke om en opioidoverdosis.
English: Nyxoid can cause acute withdrawal symptoms if the patient is dependent on opioid drugs.
Danish: Nyxoid kan forårsage akutte abstinenssymptomer, hvis patienten er afhængig af opioider.
English: Each pack contains two single-dose nasal sprays.
Danish: Hver pakke indeholder to enkeltdosis næsespray.
English: Signs and symptoms of drug withdrawal syndrome include restlessness, irritability, hyperaesthesia, nausea, vomiting, gastrointestinal pain, muscle spasms, dysphoria, insomnia, anxiety, hyperhidrosis, piloerection, tachycardia, increased blood pressure, yawning, pyrexia.
Danish: Tegn og symptomer på abstinenssyndrom omfatter rastløshed, irritabilitet, hyperæstesi, kvalme, opkastning, gastrointestinale smerter, muskelspasmer, dysfori, søvnløshed, angst, hyperhidrose, gåsehud, takykardi, forhøjet blodtryk, gaben, pyreksi.
English: • Feeling sick, vomiting, diarrhoea
Danish: • Kvalme, opkastning, diarré
English: Nyxoid is not for use in children or adolescents under 14 years.
Danish: Nyxoid er ikke beregnet til brug hos børn eller unge under 14 år.
English: The recommended dose is 1.8 mg administered into one nostril (one nasal spray).
Danish: Den anbefalede dosis er 1,8 mg administreret i det ene næsebor (én næsespray).
English: A study investigating intranasal naloxone at doses of 1, 2, 4 mg (MR903-1501) shows that the median (range) tmax associated with intranasal administration of naloxone was 15 (10, 60) minutes for
Danish: Et studie, der undersøger intranasal naloxon ved doser på 1, 2, 4 mg (MR903-1501) viser, at median (interval) tmax.
English: This medicine contains naloxone in 0.1 ml of a clear, colourless to pale yellow solution in a pre-filled nasal spray, solution in a single dose container.
Danish: Dette lægemiddel indeholder naloxon i en 0,1 ml klar, farveløs til svagt gul opløsning i en forfyldt næsespray i en enkeltdosisbeholder.
English: • Changes in behaviour including violent behaviour, nervousness, anxiety, excitement,
Danish: • Ændringer i adfærd, herunder voldelig adfærd, nervøsitet, angst, ophidselse, rastløshed eller irritabilitet
English: Administration of Nyxoid may decrease the analgesic effects of opioids used primarily to provide pain relief, due to its antagonist properties (see section 4.4).
Danish: Administration af Nyxoid kan mindske de smertestillende virkninger af opioider, der primært bruges til at give smertelindring, på grund af dets antagonistiske egenskaber (se pkt.
English: Watch out for the following symptoms in your baby during the first 24 hours after the baby is born: seizures (fits) crying more than usual increased reflexes.
Danish: Hold øje med følgende symptomer hos din baby i de første 24 timer efter, at barnet er født:
English: Other medicines and Nyxoid
Danish: Brug af anden medicin sammen med Nyxoid
English: Nyxoid is not a substitute for emergency medical care.
Danish: Nyxoid er ikke en erstatning for akut medicinsk pleje.
English: Peel off the back of the blister from the corner to remove the nasal spray from the container.
Danish: Riv blisterpakningens bagside af fra hjørnet, så du kan tage næsesprayen ud af pakningen.
English: България ТП„Мундифарма медикъл ООД“
Danish: ТП„Мундифарма медикъл ООД“ Тел.
English: Nyxoid is intended to be administered as a part of a resuscitation intervention in suspected overdose casualties, where opioid drugs may be involved or suspected, likely in a non-medical setting.
Danish: Nyxoid er beregnet til at blive administreret som en del af en livreddende behandling ved mistanke om overdosisulykker, som skyldes eller formodes at skyldes opioidmedikamenter, sandsynligvis i ikkemedicinske omgivelser.
English: • Life-threatening irregular heartbeat, heart attack
Danish: • Livstruende uregelmæssig hjerterytme, hjerteanfald
English: What Nyxoid is and what it is used for What you need to know before you receive Nyxoid How Nyxoid is to be given Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du får Nyxoid Sådan skal Nyxoid gives Bivirkninger
English: No clinical data on effects of naloxone on fertility are available, however data from rat studies (see section 5.3) indicate no effects.
Danish: Der foreligger ingen kliniske data vedrørende naloxons virkning på fertiliteten, men data fra forsøg med rotter (se pkt.
English: • Skin problems such as itching, rash, redness, swelling, severe flaking or peeling of the skin.
Danish: • Hudproblemer som f.eks. kløe, udslæt, rødme, hævelse, alvorlig afskalning af huden
English: It is to be given right away and does not take the place of emergency medical care.
Danish: Det skal gives med det samme og kan ikke erstatte akut behandling.
English: Receiving Nyxoid can lead to a rapid reversal of the opioid effect which can cause an acute withdrawal syndrome (see section 4.8).
Danish: Indgivelse af Nyxoid kan føre til en hurtig reversion af den opioide virkning, der kan udløse akut abstinenssyndrom (se pkt.
English: Name and address of the manufacturer(s) responsible for batch release BARD PHARMACEUTICALS LIMITED UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD,
Danish: BARD PHARMACEUTICALS LIMITED UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD,
English: When administered to opioid dependent subjects, naloxone can cause acute withdrawal symptoms in some individuals.
Danish: Når det administreres til opioidafhængige personer, kan naloxon forårsage akutte abstinenssymptomer hos nogle personer.
English: As the duration of action of some opioid agonists may be longer than that of naloxone, the effects of the opioid agonist may return as the effects of naloxone disappear.
Danish: Da varigheden for nogle opioidagonisters virkning kan være længere end naloxons, kan opioidagonistens virkning vende tilbage, når virkningen af naloxon ophører.
English: Nyxoid is intended for use by appropriately trained individuals.
Danish: Nyxoid er kun beregnet til brug af personer, der er oplært i administration af lægemidlet.
English: The patient should be monitored closely until emergency help has arrived after being given this medicine.
Danish: Efter at have fået denne medicin, bør patienten overvåges nøje, indtil der kommer nødhjælp.
English: Nyxoid is indicated in adults and adolescents aged 14 years and over.
Danish: Nyxoid er indiceret til voksne og unge på 14 år og derover.
English: • Dizziness, headache
Danish: • Svimmelhed, hovedpine
English: Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sygeplejerskens anvisning.
English: Typical opioid withdrawal syndrome is expected with naloxone which may be caused by the abrupt withdrawal of opioid in persons physically dependent on them.
Danish: Der forventes typisk opioidabstinenssyndrom efter anvendelse af naloxon, hvilket kan skyldes den pludselig seponering af opioider hos personer, der er fysisk afhængige af dem. Bivirkningstabel
English: Conditions to look out for
Danish: Forhold, du skal være opmærksom på
English: Each nasal spray contains one single dose of naloxone.
Danish: Hver næsespray indeholder én enkelt dosis naloxon.
English: If the duration of action of the opioid agonist exceeds that of intranasal naloxone, the effects of the opioid agonist may return, necessitating a second intranasal naloxone administration.
Danish: Hvis den indsættende virkningsvarighed af opioidagonisten overstiger den fra intranasal administreret naloxon, kan virkningerne af opioidagonisten vende tilbage, hvilket nødvendiggør en ny intranasal administration af naloxon.
English: • HCP Guidance Document with training delivery instructions
Danish: • Det vejledende dokument til sundhedsprofessionelle med instruktioner i, hvordan træning foranstaltes
English: In opioid dependent pregnant women, naloxone administration can cause withdrawal symptoms in newborn infants (see section 4.4).
Danish: Administration af naloxon til gravide, opioidafhængige kvinder kan forårsage abstinenssymptomer hos nyfødte spædbørn (se pkt.
English: Vascular disorders
Danish: Vaskulære forstyrrelser
English: Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.
Danish: Nyxoid er beregnet til akutbehandling af kendt eller formodet opioidoverdosis, som kommer til udtryk ved respiratorisk depression og/eller depression af centralnervesystemet, både på hospitaler/lægeklinikker og uden for disse.
English: It is not a substitute for emergency medical care.
Danish: Det er ikke en erstatning for akut behandling.
English: Hypotension, Hypertension Respiratory, thoracic and mediastinal disorders Uncommon Hyperventilation Very rare
Danish: Almindelig Hypotension, hypertension Luftveje, thorax og mediastinum Ikke almindelig
English: Nyxoid is intended for use in adolescents 14 years and over.
Danish: Nyxoid er beregnet til brug hos unge på 14 år og derover.
English: Remove the nasal spray nozzle from the nostril after giving the dose.
Danish: Fjern dysen fra næseboret, efter du har indgivet dosen
English: Package leaflet: Information for the user Nyxoid 1.8 mg nasal spray, solution in a single-dose container
Danish: Indlægsseddel: Information til brugeren Nyxoid 1,8 mg næsespray, opløsning i enkeltdosisbeholder naloxon
English: - The active substance is naloxone.
Danish: - Aktivt stof: naloxon.
English: Contents of the pack and other information What Nyxoid contains
Danish: Pakningsstørrelser og yderligere oplysninger Nyxoid indeholder:
English: - The other ingredients are trisodium citrate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and purified water.
Danish: - Øvrige indholdsstoffer: trinatriumcitratdihydrat, natriumchlorid, saltsyre, natriumhydroxid og renset vand.
English: Trisodium citrate dihydrate Sodium chloride Hydrochloric acid Sodium hydroxide Purified water
Danish: Trinatriumcitratdihydrat Natriumchlorid Saltsyre
English: The Effectiveness of Nyxoid (intranasal naloxone) Administration by Lay People in Reversing Opioid Overdose.
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): Effektiviteten af Nyxoid (intranasal naloxon) Administration af lægpersoner ved reversering af opioidoverdosis.
English: Tel: +44(0) 1223 424444
Danish: Napp Pharmaceuticals Limited Tel: +44(0) 1223 424444
English: • It should be available as o A link for online access in the HPD and PIC o Memory stick for HCP use to train, if WiFi not accessible
Danish: • Videoen skal være tilgængelig som o Et link som kan tilgås online i HPD og PIC
English: • Increased skin sensitivity
Danish: • Øget hudfølsomhed • Søvnbesvær
English: Nasal spray, solution in a single-dose container 2 single-dose containers
Danish: Næsespray, opløsning i en enkeltdosis-beholder 2 enkeltdosisbeholdere
English: The pain may increase when you receive Nyxoid.
Danish: Smerterne kan blive værre, når du får Nyxoid
English: • Body aches and stomach cramps
Danish: • Kropssmerter og mavekramper
English: Very rare: may affect up to 1 in 10,000 people
Danish: Meget sjældne: Kan forekomme hos op til 1 ud af 10.000 personer
English: Ιρλανδία Tel +353 1 206 3800
Danish: Mundipharma Pharmaceuticals Limited Tel +353 1 206 3800
English: Excipients: Trisodium citrate dihydrate, sodium chloride, hydrochloric acid sodium hydroxide, purified water.
Danish: Hjælpestoffer: Trinatriumcitratdihydrat, natriumchlorid, saltsyre, natriumhydroxid, renset vand.
English: The prescriber should describe the symptoms which allow presumptive diagnosis of central nervous system (CNS) / respiratory depression, the indication and the instructions for use with the patient and / or person who might be in a position to administer this product to a patient experiencing a known or suspected opioid overdose event.
Danish: Derudover skal den ordinerende læge gennemgå indikationen og anvisningerne for anvendelse af produktet sammen med patienten og/eller en anden hjælper, der kan tænkes at skulle administrere produktet til en patient med kendt eller formodet overdosering af opioider.
English: • Slow heart rate
Danish: • Langsom puls
English: • Sweating, fever, goose bumps, shivering or trembling
Danish: • Svedtendens, feber, gåsehud, sitren eller rysten
English: Puh/Tel: + 358 (0)9 8520 2065
Danish: Mundipharma Oy Puh/Tel: + 358 (0)9 8520 2065 info@mundipharma.fi
English: Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described, more typically when naloxone is used post-operatively (see sections 4.4 and 4.8).
Danish: Blodtryksforhøjelse, hjertearytmi, lungeødem og hjertestop er blevet beskrevet, mere typisk hvor naloxon bruges postoperativt (se pkt.
English: Cardiac fibrillation, Cardiac arrest
Danish: Hjerteflimren, hjertestop
English: • Being sick (vomiting)
Danish: • kramper (anfald)
English: Mundipharma Oy
Danish: Opioidabstinenssyndrom
English: • Fast heart rate
Danish: • Hurtig puls
English: Each nasal spray container delivers 1.8 mg of naloxone (as hydrochloride dihydrate).
Danish: Hver næsespraybeholder leverer 1,8 mg naloxon (som hydrochloriddihydrat).
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: Kan forekomme hos op til 1 ud af 100 personer
English: • Irregular heart beat
Danish: • Uregelmæssig hjerterytme
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: Kan forekomme hos flere end 1 ud af 10 personer • Kvalme
English: Mundipharma A/S
Danish: Mundipharma A/S c/o Icepharma hf.
English: Place the nasal spray within easy reach.
Danish: Placer næsesprayen inden for rækkevidde.
English: The half value duration (HVD) values for intranasal administration were longer than for IM administration (intranasal, 2 mg, 1.27h, IM, 0.4 mg 1.09h) from which we can infer a longer duration of action of naloxone given by the intranasal rather than the IM route.
Danish: : 0,4 mg, 1,09 timer), ud fra hvilket kan udledes, at der er en længere virkningsvarighed af naloxon givet intranasalt end intramuskulært.
English: Nyxoid 1.8 mg nasal spray, solution in a single-dose container naloxone
Danish: Nyxoid 1,8 mg næsespray, opløsning i en enkeltdosis-beholder naloxon