FrancophonIA/ELRC3.0 huggingface dataset:
English: • The counter will stay on the number “8”.
Danish: • Tælleren vil stadig vise tallet ”8”.
English: In these patients, opioids may decrease respiratory drive and increase airway resistance.
Danish: Hos disse patienter kan opioider nedsætte det respiratoriske drive og øge modstanden i luftvejene.
English: After the PecFent bottle has been primed (prepared for use) it delivers 2 full sprays.
Danish: Efter at flasken med PecFent er blevet primet (forberedt til brug), afgiver den 2 fulde spraydoser.
English: Not all presentations or pack sizes may be marketed.
Danish: Ikke alle udformninger eller pakningsstørrelser er nødvendigvis markedsført.
English: • you suffer from recurrent nose bleeding - he may advise an alternative treatment
Danish: • får næseblod gentagne gange - lægen kan tilråde en anden behandling
English: The curves for each dose level are similar in shape with increasing dose levels producing increasing plasma fentanyl levels.
Danish: Kurverne for hvert doseringsniveau er sammenlignelige i form, og forhøjede doseringsniveauer producerer forhøjede niveauer af plasma-fentanyl.
English: • You should not start breast-feeding within 5 days after the last dose of PecFent.
Danish: • Du må først begynde at amme 5 dage efter den sidste dosis PecFent.
English: • Do not use PecFent during child birth.
Danish: • Brug ikke PecFent ved fødsel.
English: Embryo-foetal developmental toxicity studies conducted in rats and rabbits revealed no compoundinduced malformations or developmental variations when administered during the period of organogenesis.
Danish: Toksicitetsundersøgelser af embryoføtal udvikling udført med rotter og kaniner viste ingen stofinducerede misdannelser eller udviklingsvariationer, ved administration under organogeneseperioden.
English: • Fentanyl is absorbed quickly through the lining of your nose and into the blood stream.
Danish: • Fentanyl absorberes hurtigt fra din næse til blodomløbet.
English: Pharmacotherapeutic group: Analgesics; opioids; phenylpiperidine derivatives; ATC code: N02AB03.
Danish: Farmakoterapeutisk klassifikation: Analgetika; opioider; phenylpiperidin-derivater; ATC-kode: N02A B03.
English: Propylparahydroxybenzoate may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (if the medicinal product is not correctly administered).
Danish: Propylparahydroxybenzoat kan forårsage allergiske reaktioner (muligvis forsinkede) og i sjældne tilfælde bronkospasme (hvis lægemidlet ikke administreres korrekt).
English: Further findings at maternally toxic doses in F1 pups were delayed physical development, sensory functions, reflexes and behaviour.
Danish: Yderligere fund hos F1-unger ved doser, som forårsagede toksicitet hos moderen, var forsinket fysisk udvikling, sensoriske funktioner, reflekser og opførsel.
English: If adverse reactions are intolerable or persistent, the dose should be reduced or treatment with PecFent replaced by another analgesic.
Danish: Hvis bivirkningerne ikke kan tolereres eller varer ved, skal dosis reduceres, eller behandlingen med PecFent skal erstattes af et andet analgetikum.
English: Warnings and precautions Keeping PecFent safe from children
Danish: Advarsler og forsigtighedsregler Sådan holdes PecFent på sikker afstand af børn
English: The variability of the pharmacokinetics of fentanyl was considerable following treatment with both PecFent and OTFC.
Danish: Variabiliteten af fentanyls farmakokinetik var anselig efter behandling med både PecFent og OTFC.
English: The bottle should be removed from the child resistant container immediately prior to use and the protective cap removed.
Danish: Flasken bør fjernes fra den børnesikrede beholder umiddelbart før brug, og beskyttelseshætten skal fjernes.
English: What you need to know before you use PecFent Do not use PecFent if:
Danish: Det skal du vide, før du begynder at bruge PecFent Brug ikke PecFent:
English: • Do not drink grapefruit juice while using PecFent.
Danish: • Drik ikke grapefrugtjuice, mens du bruger PecFent.
English: Following treatment of the acute rhinitic state with oxymetazoline, there were reductions in Cmax and exposure, and increases in Tmax that were statistically, and possibly clinically, significant.
Danish: Efter behandling af stadiet med akut rhinitis med oxymetazolin, sås der reduktioner af Cmax og eksponering, og forhøjelser af Tmax, som var statistisk og muligvis klinisk signifikant.
English: • you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.
Danish: • hvis du ikke regelmæssigt bruger ordineret medicin (opioider) (f.eks. codein, fentanyl, hydromorphon, morfin, oxycodon, pethidin), hver dag i henhold til et regelmæssigt skema, i mindst en uge, for at kontrollere din vedvarende smerte.
English: Immediate management of opioid overdose includes ensuring a patent airway, physical and verbal stimulation of the patient, assessment of the level of consciousness, ventilatory and circulatory status, and assisted ventilation (ventilatory support) if necessary.
Danish: Øjeblikkelig behandling af en opioidoverdosering omfatter etablering af frie luftveje, fysisk og verbal stimulering af patienten, vurdering af bevidsthedsniveauet, ventilations- og kredsløbsstatus, og assisteret ventilation (understøttet ventilation), hvis det er nødvendigt.
English: Animal data have shown that, following absorption, fentanyl is rapidly distributed to the brain, heart, lungs, kidneys and spleen followed by a slower redistribution to muscles and fat.
Danish: Data fra forsøg med dyr har vist, at fentanyl hurtigt distribueres til hjernen, lungerne, nyrerne og milten efter absorption, efterfulgt af en langsommere redistribution til muskler og fedt.
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger: (kan forekomme hos op til 1 ud af 10 personer):
English: • misusing the medicine
Danish: • forkert brug af medicinen
English: • painful, sore or inflamed throat or nose
Danish: • smertefuld, øm eller betændt hals eller næse
English: Although muscle rigidity interfering with respiration has not been seen following the use of PecFent, this is possible with fentanyl and other opioids.
Danish: Selvom der ikke er blevet observeret muskelstivhed, som påvirker respirationen efter brug af PecFent, er dette en mulighed med fentanyl og andre opioider.
English: You may experience withdrawal symptoms similar to the possible side effects of PecFent when discontinuing PecFent.
Danish: Du kan opleve abstinenssymptomer, der ligner de mulige bivirkninger for PecFent, når du stopper PecFent.
English: • Only use PecFent nasal spray if you have received the proper information regarding the use of the device and the safety precautions from the prescriber and/or the pharmacist
Danish: • Anvend kun PecFent næsespray, hvis du har fået korrekt information om brugen af denne anordning og sikkerhedsforanstaltninger fra den ordinerede læge eller apoteket
English: Do not use more than the dose that your doctor prescribes to treat any single pain episode.
Danish: Du må ikke anvende mere end den dosis, din læge har ordineret til at behandle hver enkelt smerteepisode.
English: It is subject to first pass hepatic and intestinal metabolism and the metabolites do not contribute to fentanyl's therapeutic effects.
Danish: Det er underlagt første-passage-metabolisme i lever og tarm, og metabolitterne bidrager ikke til fentanyls terapeutiske virkninger.
English: Treatment of acute pain other than breakthrough pain.
Danish: Behandling af andre akutte smerter end gennembrudssmerter.
English: • If the spray is blocked, aim the spray away from you (and any other people) and push firmly down on the pump.
Danish: • Hvis sprayen er blokeret, skal du vende sprayen væk fra dig selv (og væk fra andre personer) og trykke godt ned på pumpen.
English: They have high affinity to opioid receptors with relatively low intrinsic activity and, therefore, partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients.
Danish: De har høj affinitet over for opioidreceptorer med relativ lav intrinsisk aktivitet, og modvirker derfor delvist fentanyls analgetiske virkning og kan inducere abstinenssymptomer hos opioidafhængige patienter.
English: The judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.
Danish: Velovervejet anvendelse af naloxon eller en anden opioidantagonist kan være påkrævet i nogle tilfælde, men det er forbundet med risiko for at fremkalde et akut abstinenssyndrom.
English: Evaluation of brain slides from the carciogenicity study in rats revealed brain lesions in animals administered high doses of fentanyl citrate.
Danish: Evaluering af hjernesnit fra karcinogenicitetsstudiet med rotter viste hjernelæsioner hos dyr, der fik administreret høje doser fentanylcitrat.
English: If it occurs, it should be managed by the use of assisted ventilation, by an opioid antagonist, and as a final alternative, by a neuromuscular blocking agent.
Danish: Hvis det forekommer, skal det behandles med assisteret ventilation, med en opioidantagonist, og som det sidste alternativ, med et neuromuskulært blokerende stof.
English: This is because it may affect the way in which your body breaks down the medicine.
Danish: Dette skyldes, at det kan påvirke den måde, din krop nedbryder medicinen på
English: Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
Danish: Patienter, der ikke modtager opioid-vedligeholdelsesbehandling, da der er øget risiko for respirationsdepression.
English: Typical opioid adverse reactions are to be expected with PecFent.
Danish: Typiske bivirkninger ved opioidbehandling kan forventes med PecFent.
English: • you have liver or kidney problems.
Danish: • du har problemer med lever eller nyrer.
English: PecFent should, therefore, be used with caution in patients with previous or pre-existing bradyarrhythmias.
Danish: PecFent bør derfor anvendes med forsigtighed til patienter med tidligere eller allerede eksisterende bradyarytmier.
English: PecFent should be titrated to an “effective” dose that provides adequate analgesia and minimises adverse reactions without causing undue (or intolerable) adverse reactions, for two consecutively treated episodes of BTP.
Danish: PecFent bør titreres til en “effektiv” dosis, der giver tilstrækkeligt analgesi og minimerer bivirkninger uden at forårsage unødige (eller uacceptable) bivirkninger, i to på hinanden følgende behandlede episoder med gennembrudssmerter.
English: Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Danish: Patienter i vedligeholdelsesbehandling med opioider tager mindst 60 mg oral morfin dagligt, mindst 25 mikrogram transdermal fentanyl pr. time, mindst 30 mg oxycodon dagligt, mindst 8 mg oral hydromorphon dagligt eller en ækvianalgetisk dosis af et andet opioid i en uge eller længere.
English: There are still doses of PecFent left in the bottle.
Danish: Der er stadig PecFent-doser tilbage i flasken.
English: Nasal use
Danish: Til nasal anvendelse
English: No data on the pharmacokinetics of PecFent in elderly patients are available.
Danish: Der foreligger ingen data om PecFents farmakokinetik hos ældre patienter.
English: Uncommon side effects: (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger: (kan forekomme hos op til 1 ud af 100 personer):
English: A spray is then administered by pressing and releasing the finger grips either side of the nozzle.
Danish: Derefter administreres en spraydosis ved at trykke på og slippe fingergrebene på hver side af spidsen.
English: Therefore, when switching between fentanyl containing medicinal products indicated for treatment of breakthrough pain, including intranasal formulations, it is essential that patients are again titrated with the new medicinal product, and not switched on a dose-for-dose (microgram-formicrogram) basis.
Danish: Derfor er det essentielt, når der skiftes mellem lægemidler indeholdende fentanyl indiceret til behandling af gennembrudssmerter, herunder intranasale midler, at patienter igen titreres med det nye lægemiddel, og ikke skiftes baseret på dosis-til-dosis (mikrogram-for-mikrogram).
English: Secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Danish: De sekundære farmakologiske virkninger er respirationsdepression, bradykardi, hypotermi, obstipation, miosis, fysisk afhængighed og eufori.
English: Hydrochloric acid (0.36%) or sodium hydroxide (for pH adjustment) Purified water
Danish: Saltsyre (0,36 %) eller natriumhydroxid (til justering af pH) Renset vand
English: If discontinuation of all opioid therapy is required, the patient must be closely followed by the doctor as gradual downward opioid titration therapy is necessary in order to avoid the possibility of abrupt withdrawal effects.
Danish: Hvis det er påkrævet, at hele opioidbehandlingen seponeres, bør patienten følges nøje af lægen, da en gradvis nedtitrering af opioidbehandlingen er nødvendig for at undgå risikoen for pludselige abstinenssymptomer.
English: The patient should be advised to write the date of first use in the space provided on the label of the child resistant container.
Danish: Patienten skal instrueres i at skrive datoen for første brug på den dertil hørende plads på den børnesikrede beholders etiket.
English: Opioids may obscure the clinical course of patients with a head injury and should be used only if clinically warranted.
Danish: Opioider kan tilsløre det kliniske forløb hos patienter med hovedtraumer, og bør kun anvendes, hvis det er klinisk påkrævet.
English: Tell your doctor or pharmacist if you have taken an MAOI medicine in the past 2 weeks before using PecFent.
Danish: Fortæl det til lægen eller på apoteket, hvis du har taget en MAO-hæmmer i løbet af de sidste 2 uger, før du brugerPecFent.
English: • medicines that might make you sleepy such as sleeping tablets, tranquilisers, muscle relaxants, medicines for anxiety or medicines for allergies (anti-histamines)
Danish: • medicin, der kan gøre dig søvnig, såsom sovetabletter, beroligende midler, muskelafslappende midler, angstmedicin eller allergimedicin (antihistaminer)
English: Figure 2: Clinically Meaningful Pain Relief - PecFent vs placebo: % Patients' Episodes With ≥2 Point Reduction in Pain Intensity
Danish: Figur 2: Klinisk betydningsfuld smertelindring - PecFent versus placebo: % patientepisoder med ≥ 2 points reduktion i smerteintensitet
English: • A dose to treat a breakthrough pain episode might be either 1 spray or 2 sprays (one in each nostril).
Danish: • En dosis til behandling af en episode med gennembrudssmerter kan være enten 1 spraydosis eller 2 spraydoser (en i hvert næsebor).
English: The mean pain intensity scores (73 patients) for all PecFent-treated episodes (459 episodes) compared to those treated with placebo (200 episodes) were significantly lower at 5, 10, 15, 30, 45 and 60 minutes following administration (see Figure 1).
Danish: De gennemsnitlige smerteintensitets-scoringer (73 patienter) for alle PecFent-behandlede episoder (459 episoder) sammenlignet med episoder behandlet med placebo (200 episoder) var signifikant lavere ved 5, 10, 15, 30, 45 og 60 minutter efter administration (se Figur 1).
English: The clinical studies of PecFent were designed to evaluate safety and efficacy in treating BTP and all patients were also on background opioid therapies, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Danish: De kliniske undersøgelser med PecFent blev designet med henblik på at evaluere sikkerhed og virkning ved behandling af gennembrudssmerter, og alle patienter var også i baggrundsbehandling med opioider såsom morfin som depottabletter eller transdermal fentanyl for deres kroniske smerter.
English: Serotonin Syndrome
Danish: Serotonergt syndrom
English: • You will need to press down and release the finger grips 4 more times while aiming the nasal spray away from you (and any other people).
Danish: • Du skal trykke/slippe fingergrebene 4 gange mere, mens du vender næsesprayen væk fra dig selv (og væk fra andre personer).
English: Product strength (micrograms)
Danish: Lægemiddelstyrke (mikrogram)
English: Titration in patients switching between immediate-release fentanyl containing products Substantial differences may exist in the pharmacokinetic profile of immediate-release fentanyl medicinal products, which result in clinically important differences in the rate and extent of absorption of fentanyl.
Danish: Titrering hos patienter, som skifter mellem immediate-release-lægemidler indeholdende fentanyl Der kan forekomme væsentlige forskelle i den farmakokinetiske profil af immediate-releaselægemidler indeholdende fentanyl, hvilket resulterer i klinisk betydningsfulde forskelle i hastigheden og graden af fentanyls absorption.
English: Superiority was demonstrated by the primary endpoint, Pain Intensity Difference within 15 minutes, which was 3.02 in patients treated with PecFent compared to 2.69 in patients treated with IRMS (p=0.0396).
Danish: Overlegenhed blev påvist ved det primære endepunkt, forskel i smerteintensitet, i løbet af 15 minutter, som var 3,02 for patienter behandlet med PecFent sammenlignet med 2,69 for patienter behandlet med IRMS (p=0,0396).
English: • you experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure.
Danish: • oplever en kombination af følgende symptomer: kvalme, opkastning, anoreksi, træthed, svaghed, svimmelhed og lavt blodtryk.
English: However, the most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be monitored for these.
Danish: De mest alvorlige bivirkninger er dog respirationsdepression (der kan føre til apnø eller respirationsstop), kredsløbsdepression, hypotension og shock, og alle patienter bør overvåges for disse bivirkninger.
English: To prime the bottle, please follow the instructions below:
Danish: Flasken primes ved at følge vejledningen nedenfor:
English: • medicines for depression called ‘monoamine-oxidase inhibitors' (MAOI).
Danish: • medicin mod depression, som kaldes ‘monoaminoxidasehæmmere' (MAO-hæmmere).
English: • Tell your doctor if your dose of PecFent does not relieve your breakthrough pain.
Danish: • Fortæl det til din læge, hvis din dosis af PecFent ikke lindrer dine gennembrudssmerter.
English: This will go up each time the spray is used.
Danish: hver gang sprayen bruges.
English: Fentanyl is metabolised in the liver to norfentanyl by cytochrome CYP3A4 isoform.
Danish: Fentanyl metaboliseres i leveren til norfentanyl af cytokrom CYP3A4-isoform.
English: Intentional drug misuse Medication error
Danish: Tilsigtet stofmisbrug Medicineringsfejl
English: • This means the medicine gets into your system quickly to relieve your breakthrough pain.
Danish: • Det betyder, at medicinen hurtigere kommer ind i dit system, så dine gennembrudssmerter lindres.
English: If this dose is not successful, the patient may be instructed to increase to two 400 microgram sprays (one in each nostril).
Danish: Hvis denne dosis ikke virker, kan patienten instrueres i at forøge til to 400 mikrogram spraydoser (en i hvert næsebor).
English: As soon as PecFent is no longer needed, patients and members of their household must be advised to systematically dispose of any bottles remaining from a prescription as soon as possible by returning them to their child-resistant container and discarding them, according to local requirements or by returning them to the pharmacy.
Danish: Så snart som PecFent ikke behøves længere, skal patienter og andre i husholdningen rådes til snarest muligt systematisk at bortskaffe alle tiloversblevne flasker fra en ordination ved at sætte dem tilbage til den børnesikrede beholder og bortskaffe dem i overensstemmelse med lokale retningslinjer eller ved at returnere dem til apoteket.
English: If you experience withdrawal symptoms, you should contact your doctor.
Danish: Hvis du oplever abstinenssymptomer, skal du kontakte din læge.
English: This is because PecFent could be life-threatening if taken by a child by accident.
Danish: Dette skyldes, at PecFent kan være livsfarligt, hvis et barn indtager det ved et uheld.
English: If PecFent is administered, an antidote for the child should be readily available.
Danish: Hvis PecFent administreres, skal der være en antidot parat til barnet.
English: • The pharmacist must inform the patients that in order to prevent theft and misuse of PecFent nasal spray they have to keep it in a safe place to avoid misuse and diversion
Danish: • Apoteket skal informere patienterne om, at de skal opbevare PecFent næsespray på et sikkert sted, for at undgå tyveri og misbrug og diversion
English: There are 8 full sprays in each PecFent bottle.
Danish: Der er 8 fulde spraydoser i hver PecFent-flaske.
English: Nevertheless, in view of the importance of renal and hepatic function in the metabolism and clearance of fentanyl, additional care should be exercised in the use of PecFent in the elderly.
Danish: Ikke desto mindre skal der, på baggrund af hvor vigtig nyre- og leverfunktionen er for fentanyls metabolisme og clearance, udvises særlig forsigtighed ved anvendelse af PecFent til ældre.
English: The metabolic pathways following nasal administration of PecFent have not been characterised in clinical studies.
Danish: Den metaboliske pathway efter nasal administration af PecFent er ikke blevet karakteriseret i kliniske undersøgelser.
English: • being less aware or responsive, losing consciousness
Danish: • være mindre opmærksom eller reagere langsommere, bevidsthedstab
English: Pharmacokinetic parameters in adult subjects receiving PecFent and OTFC
Danish: Farmakokinetiske parametre hos voksne forsøgspersoner, der fik PecFent og OTFC
English: Patients with pain who receive chronic opioid therapy develop tolerance to respiratory depression and hence the risk of respiratory depression in these patients is reduced.
Danish: Patienter med smerter, der får kronisk opioidbehandling, udvikler tolerans over for respirationsdepression, og derfor er risikoen for respirationsdepression reduceret hos disse patienter.
English: The MAH shall ensure that, at launch, all physicians, pharmacists and patients expected to prescribe/use PecFent are provided with educational material informing about the correct and safe use of the product.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, apoteker og patienter, som forventes at ordinere/anvende PecFent, forsynes med uddannelsesmateriale på tidspunktet for markedsføring, der informerer dem om den korrekte og sikre anvendelse af lægemidlet.
English: • Severe breathing problems
Danish: • svære vejrtrækningsproblemer
English: • The counter will stay on the number “2”.
Danish: • Tælleren vil stadig vise tallet ”2”.
English: • From treatment initiation, patients should be closely followed and the dose titrated until an effective dose is reached and confirmed for two consecutively treated episodes of BTP.
Danish: • Patienterne skal følges nøje fra behandlingens indledning, og dosen skal titreres, indtil en effektiv dosis opnås, og bekræftes ved behandling af to på hinanden følgende episoder med gennembrudssmerter.
English: Attention deficit/hyperactivity disorder
Danish: ADHD (attention deficit/hyperactivity disorder)
English: o If there are any unwanted therapeutic sprays remaining in the bottle, the patient should be instructed to expel these as follows:
Danish: o Hvis der er behandlingsdoser tilbage i flasken, som ikke skal bruges, skal patienten instrueres i at pumpe disse ud på følgende måde