FrancophonIA/ELRC3.0 huggingface dataset:
English: Following passage into the systemic circulation, ziconotide is expected to be primarily susceptible to proteolytic cleavage by various ubiquitous peptidases/proteases present in most organs (e.g., kidney, liver, lung, muscle, etc.), and thus degraded to peptide fragments and its individual constituent free amino acids.
Danish: Efter passage ind i det systemiske kredsløb forventes ziconotid at være primært disponeret til proteolytisk spaltning af diverse ubikvitære peptidaser/proteaser, der er tilstede i de fleste organer (f.eks. nyre, lever, lunge, muskel etc.), og det bliver derved degraderet til peptidfragmenter og dets individuelle frie aminosyrebestanddele.
English: Prialt is supplied in packs containing a single vial of 20 ml.
Danish: Prialt leveres i pakninger indeholdende et enkelt hætteglas af 20 ml.
English: Stability has been demonstrated for 21 days at room temperature in the CADD-Micro pump.
Danish: Stabilitet er dokumenteret i 21 dage ved stuetemperatur i CADD-Micro pumpen.
English: Hence, ziconotide appears to be mainly eliminated from the CSF (mean t½ = 4.6 hr) by bulk flow of CSF out of the CNS through the arachnoid villi with subsequent transfer into the systemic circulation.
Danish: Derfor viser ziconotid sig hovedsagelig at blive elimineret fra CSF (middel t½ = 4,6 t) ved totalflow af CSF ud af CNS gennem granulationes arachnoidales med efterfølgende overførsel ind i det systemiske kredsløb.
English: Withdrawal of concomitant CNS depressant medicinal products should also be considered as they may contribute to the reduced level of arousal.
Danish: Nedtrapning af samtidigt administrerede CNSdeprimerende lægemidler bør ligeledes overvejes, da de kan være medvirkende til at nedsætte graden af vågenhed.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: No specific studies with ziconotide in humans have been conducted to evaluate effects on fertility.
Danish: Der er ikke udført specifikke studier med ziconotid hos mennesker for at evaluere virkningen på fertilitet.
English: The maximum dose is 21.6 micrograms/day.
Danish: Maksimumdosis er 21,6 mikrogram/dag.
English: If discontinuing opiates when initiating ziconotide therapy, opiate withdrawal should be gradual.
Danish: Hvis behandling med opiater skal ophøre, når ziconotid behandlingen påbegyndes, skal behandlingen med opiater nedtrappes gradvist.
English: In one clinical study a male cancer patient received an accidental IT ziconotide overdose of 744 μg over a 24-hour period (31 μg/hour) and resumed treatment at the intended dose after experiencing a reduction in Visual Analog Scale of Pain Intensity (VASPI) from 82 to 2.5 mm.
Danish: I ét klinisk studie fik en mandlig cancerpatient en utilsigtet IT ziconotid overdosis på 744 μg over en 24 timers periode (31 μg/time) og genoptog behandling ved den tilsigtede dosis efter at have oplevet en reduktion fra 82 til 2,5 mm i Visuel Analog Skala (VAS-skala) til måling af smerteintensitet.
English: Prialt is supplied in packs containing a single vial of either 1 ml, 2 ml or 5 ml.
Danish: Prialt leveres i pakninger indeholdende et enkelt hætteglas af enten 1 ml, 2 ml eller 5 ml.
English: Nervous system adverse reactions, particularly dizziness, nausea and abnormal gait appear to be correlated with CSF exposure, though a definitive relationship has not been established.
Danish: Bivirkninger i nervesystemet, i særdeleshed svimmelhed, kvalme og abnorm gangart, synes at være korreleret til CSF eksponering, selv om en definitiv sammenhæng ikke er blevet fastslået.
English: Clinical studies 201 and 202 indicate that the combination of IT ziconotide and IT morphine may effectively reduce pain and decrease systemic opioid use over a sustained period of time for patients whose pain was inadequately controlled with their maximum tolerated dose of IT ziconotide (median 8.7 μg/day, mean 25.7 μg/day - study 201) or with IT morphine (study 202) alone.
Danish: De kliniske forsøg 201 og 202 indikerer, at kombinationen af IT ziconotid og IT morfin effektivt kan reducere smerte og nedsætte brugen af systemiske opioider over en forlænget tidsperiode hos patienter, hvis smerte blev utilstrækkeligt kontrolleret med deres maksimalt tolererede IT ziconotid dosis (middel 8,7 μg/dag, gennemsnitlig 25,7 μg/dag, forsøg 201) eller med IT morfin alene (forsøg 202).
English: Lower catheter tip placement, e.g. at the lumbar level, may reduce the incidence of ziconotide-related neurological adverse reactions.
Danish: Lavere placering af kateterspidsen, f.eks. ved lumbalt niveau, kan reducere forekomsten af ziconotid-relaterede neurologiske bivirkninger.
English: - If you have any of the following symptoms: high temperature, headache, stiff neck, tiredness, confusion, feeling sick, vomiting or occasional fits, these may be signs of meningitis.
Danish: - Hvis De har et eller flere af følgende symptomer: høj temperatur, hovedpine, nakkestivhed, træthed, konfusion, kvalme, opkastning eller af og til får anfald, kan disse symptomer være tegn på meningitis.
English: Plasma concentrations following continuous (≥ 48 h) IT infusion (≤ 21.6 μg/day) appear to be relatively low and typically undetectable (i.e., about 80% of plasma samples collected from pain patients contain no quantifiable medicinal product; < 0.04 ng/ml).
Danish: Plasma koncentrationerne efter kontinuerlig (≥ 48 t) IT infusion (≤ 21,6 μg/dag) viste sig at være relativt lave og typisk ikke-målbare (dvs. cirka 80 % af plasma prøverne indsamlet fra smertepatienter indeholder intet kvantificerbart lægemiddel; < 0,04 ng/ml).
English: Given the occurrence of analgesia and adverse reactions at similar doses, the recommended interval between dose increases is 48 hours or more.
Danish: Fordi analgesi opnås og bivirkninger forekommer ved samme eller lignende doser, er det anbefalede interval mellem dosisforøgelser 48 timer eller mere.
English: Patients should be titrated in dose increments of ≤ 2.4 μg/day, up to a maximum dose of 21.6 μg/day.
Danish: Patienten bør titreres i dosisforøgelser på ≤ 2,4 μg/dag op til en maksimumdosis på 21,6 μg/dag.
English: Metabolism and nutrition disorders appetite decreased, anorexia
Danish: Metabolisme og ernæring nedsat appetit, anoreksi
English: Due to the wide distribution of these peptidases it is not expected that hepatic or renal impairment would affect the systemic clearance of ziconotide.
Danish: På grund af den brede distribution af disse peptidaser forventes det ikke, at nedsat lever- eller nyrefunktion vil have indflydelse på den systemiske clearance af ziconotid.
English: The concentration of the solution used in the infusion pump must be no lower than 5 μg/ml ziconotide in an external pump and 25 μg/ml in an internal pump.
Danish: Koncentrationen af den opløsning, som anvendes i infusionspumpen må ikke være lavere end 5 μg/ml ziconotid i en ekstern pumpe og 25 μg/ml i en intern pumpe.
English: Meningitis due to the entrance of organisms along the catheter track or inadvertent contamination of the infusion system is a known complication of intrathecal medicinal product administration, especially with external systems.
Danish: Meningitis forårsaget af indtrængen af organismer langs kateteret mellem kateter og væv eller utilsigtet kontamination af infusionssystemet er en kendt komplikation i forbindelse med intratekal indgivelse af lægemidler - især i forbindelse med eksterne systemer.
English: It is recommended that patients undergo a neuropsychiatric evaluation before and after starting intrathecal ziconotide.
Danish: Det anbefales, at patienterne evalueres neuropsykiatrisk før og efter intratekalt ziconotid påbegyndes.
English: Following one-hour IT administration (1 - 10 μg), both cumulative exposure (AUC; range: 83.6608 ng/h/ml) and peak exposure (Cmax; range: 16.4 - 132 ng/ml) values were variable and dose-dependent, but appeared only approximately dose-proportional.
Danish: Efter én times IT administration (1 - 10 μg) var værdierne for både kumulativ eksponering (AUC; område: 83,6 - 608 ng/t/ml) og peak eksponering (Cmax; område: 16,4 - 132 ng/ml) variable og dosisafhængige, men syntes kun omtrentligt dosis-proportionale.
English: No adverse effects on female reproduction and post-natal development in rats were seen at systemic exposures up to 2,300 times human exposures at the maximum recommended intrathecal dose.
Danish: Der blev ikke set bivirkninger på hunkønsreproduktion og postnatal udvikling hos rotter ved systemisk eksponering op til 2.300 gange de humane eksponeringer ved den maksimalt anbefalede intratekale dosis.
English: Specific clinical medicinal product interaction studies have not been conducted with ziconotide.
Danish: Der er ikke udført specifikke kliniske lægemiddelinteraktionsstudier med ziconotid.
English: The concentration of Prialt in a naïve pump may be reduced due to adsorption onto the surfaces of the device, and/or dilution by the residual space of the device.
Danish: Koncentrationen af Prialt kan i en ubrugt pumpe blive reduceret på grund af absorptionen på anordningens overflade og/eller fortynding på grund af restskyllevæske i anordningens hulrum.
English: Based on very limited clinical investigations, both angiotensin converting enzyme inhibitors (e.g., benazepril, lisinopril and moexipril) and HIV protease inhibitors (e.g., ritonavir, saquinavir, indinavir), have no readily apparent effect on plasma ziconotide exposure.
Danish: Baseret på meget begrænsede kliniske undersøgelser har hverken angiotensin konverterende enzym hæmmere (f.eks. benazepril, lisinopril og moexipril) eller HIV protease hæmmere (f.eks. ritonavir, saquinavir, indinavir) nogen klar tilsyneladende virkning på plasma ziconotid eksponering.
English: If after starting Prialt you experience a worsening of your depression or have any other symptoms affecting your mood, please inform your healthcare professional.
Danish: Hvis De, efter Prialt startes, oplever en forværring af Deres depression, eller De har andre symptomer, der påvirker Deres humør, skal De informere Deres læge eller sundhedspersonalet.
English: In subchronic continuous intrathecal infusion studies in rats and dogs, behavioural effects were seen at doses ≥ 8-fold the maximum recommended clinical intrathecal infusion dose of 21.6 μg/day (on a mg/kg basis).
Danish: I studier med subkronisk kontinuerlig intratekal infusion hos rotter og hunde blev der observeret adfærdsvirkninger ved doser ≥ 8 gange den maksimalt anbefalede kliniske intratekale infusionsdosis på 21,6 μg/dag (på en mg/kg basis).
English: Examination of the patency of the intrathecal catheter should be considered if the required ziconotide dose continually increases and there is no benefit or increase in adverse reactions.
Danish: Undersøgelse af det intratekale kateters åbenhed bør overvejes, hvis den krævede ziconotid dosis bliver ved med at blive sat op, og der ikke observeres fordele af behandlingen eller forværring af bivirkningerne.
English: Chemical and physical in-use stability has been demonstrated for 14 days at 37ºC in the Synchromed pump when the pump has not previously been exposed to the medicinal product.
Danish: Kemisk og fysisk stabilitet er dokumenteret i 14 dage ved 37 °C i Synchromed pumpen, når pumpen ikke tidligere er blevet eksponeret for lægemidlet.
English: The cognitive effects of ziconotide are typically reversible within 1 - 4 weeks after discontinuation of the medicinal product, but may persist in some cases.
Danish: De kognitive virkninger af ziconotid er typisk reversible inden for 1 - 4 uger efter afbrydelse af lægemidlet, men kan i nogle tilfælde persistere.
English: Elevations in creatine phosphokinase were usually asymptomatic.
Danish: Forhøjede niveauer af kreatinkinase var normalt asymptomatiske.
English: There is no evidence of the development of pharmacological tolerance to ziconotide in patients.
Danish: Der er hos patienter ingen evidens på udvikling af farmakologisk tolerans over for ziconotid.
English: The medicine will be administered continuously from a pump either implanted into your abdominal wall or placed externally in a belt pouch.
Danish: Medicinen vil blive administreret kontinuerligt fra en pumpe, som enten er indopereret i bugvæggen, eller som bliver båret i en bæltepung.
English: Unless otherwise noted the table shows the incidence rates of adverse reactions reported in the intrathecal clinical trials with ziconotide (short- and long-term exposure).
Danish: Medmindre det ellers er angivet, viser tabellen hyppigheden af forekomsten af bivirkninger indberettet i de intratekale kliniske forsøg med ziconotid (kort og længevarende eksponering).
English: - If you observe any signs of infection around the tube, such as skin redness, swelling, pain or discharge, you must tell your doctor immediately and seek treatment for the infection.
Danish: - Hvis De observerer tegn på infektion omkring slangen såsom rødmen af huden, hævelse, smerte eller udflåd, skal De omgående kontakte Deres læge og få behandling for infektionen.
English: It should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Den bør undersøges visuelt for partikler og misfarvning inden administrationen.
English: Prialt is given as a very slow continuous injection into the space surrounding the spinal cord (intrathecal use).
Danish: Prialt bliver givet som en meget langsom injektion i området omkring rygmarven (intratekal anvendelse).
English: If you feel that you are still in too much pain while receiving Prialt, or that the side effects are too great, talk to your doctor.
Danish: Hvis De føler, at De stadig har for stærke smerter, mens De får Prialt, eller hvis bivirkningerne er for voldsomme, bør De underrette Deres læge herom.
English: The aetiologies of pain in studies 95-001 (malignant pain) and 96-002 (non-malignant pain) were varied and included bone pain (n = 38) mostly due to bone metastases (n = 34), myelopathy (n = 38), half of whom had spinal cord injury with paralysis (n = 19), neuropathy (n = 79), radiculopathy (n = 24), spinal pain (n = 91) mostly due to failed back surgery (n = 82), and other aetiologies (n = 82).
Danish: Ætiologien af smerte i studie 95-001 (malign smerte) og 96-002 (non-malign smerte) varierede og omfattede knoglesmerte (n = 38) mest forårsaget af knoglemetastaser (n = 34), myelopati (n = 38) hvoraf halvdelen omfattede beskadigelse af rygmarven med paralyse (n = 19), neuropati (n = 79), radikulopati (n = 24), smerte i rygsøjle (n = 91) mest forårsaget af fejlslagen rygkirurgi (n = 82), og andre ætiologier (n = 82).
English: Most adverse reactions were mild to moderate in severity and resolved over time.
Danish: De fleste bivirkninger var lette til moderate i sværhedsgrad og forsvandt efterhånden.
English: IT and intravenous pharmacokinetics data are summarised below.
Danish: Nedenfor er opstillet et sammendrag af IT og intravenøse farmakokinetiske data.
English: The ziconotide dose should be reduced or discontinued if signs or symptoms of cognitive impairment or neuropsychiatric adverse reactions develop, but other contributing causes should also be considered.
Danish: Ziconotid dosen bør reduceres eller afbrydes, hvis der udvikles tegn eller symptomer på nedsat kognitiv funktion eller neuropsykiatriske bivirkninger, men andre medvirkende årsager bør ligeledes tages i betragtning.
English: • Rhabdomyolysis (may affect up to 1 in 100 people) - is breakdown of muscle fibres that can lead to kidney damage.
Danish: • Rabdomyolyse (kan forekomme hos op til 1 ud af 100 personer) - er en nedbrydning af muskelfibre, hvilket kan medføre nyreskader.
English: Prior to initiation of therapy, an internal pump must be rinsed three times with 2 ml of Prialt at 25 μg/ml.
Danish: Inden påbegyndelse af behandlingen skal en intern pumpe gennemskylles tre gange med 2 ml Prialt ved 25 μg/ml.
English: The mean plasma elimination half-life (t½) is 1.3 hr. Ziconotide is a relatively small molecular weight peptide (MW = 2,639) and is filtered by the kidney glomerulus, but only minimal amounts of ziconotide (< 1%) are recovered in human urine following intravenous infusion.
Danish: Ziconotid er en peptid med relativ lav molekylærvægt (MW = 2,639) og bliver filtreret af nyrens glomerulus, men kun minimale mængder ziconotid (< 1 %) genindvindes i human urin efter intravenøs infusion.
English: The administration of medicinal products by the intrathecal (IT) route carries the risk of potentially serious infections, such as meningitis, which may be life threatening.
Danish: I forbindelse med intratekal (IT) indgift af lægemidler er der risiko for potentielt alvorlige infektioner, såsom meningitis, som kan være livstruende.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke Prialt efter den udløbsdato, der står på etiketten og kartonen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Chronic animal studies have not been performed to assess the carcinogenic potential of ziconotide.
Danish: Der er ikke udført kroniske dyreforsøg til at vurdere ziconotids karcinogene potentiale.
English: The maximum recommended intrathecal dose is 21.6 μg/day.
Danish: Den maksimalt anbefalede intratekale dosis er 21,6 μg/dag.
English: Chemical and physical in use stability has been demonstrated for 60 days at 37°C.
Danish: Kemisk og fysisk stabilitet er dokumenteret i 60 dage ved 37 °C.
English: CSF and Plasma Pharmacokinetics of Ziconotide [mean ± SD (median)]
Danish: CSF og plasma farmakokinetikken af ziconotid [middel ± SD (median)] Indgivelsesvej Væske matrix
English: Hypersensitivity reactions, including anaphylaxis, have not been observed during clinical trials and the immunogenicity of ziconotide administered by the IT route appears to be low.
Danish: Overfølsomhedsreaktioner inklusive anafylakse er ikke blevet observeret i kliniske forsøg, og immunogeniciteten af ziconotid indgivet via IT synes at være lav.
English: Clinical efficacy and safety There were three placebo-controlled clinical trials of IT ziconotide.
Danish: Klinisk virkning og sikkerhed Der blev udført tre placebo-kontrollerede kliniske forsøg med IT ziconotid.
English: If you are experiencing depression or have a history of depression please inform your healthcare professional before you are commenced on Prialt.
Danish: Hvis De oplever depression eller tidligere har haft depression, skal De informere Deres læge eller sundhedspersonalet, før De begynder at få Prialt.
English: The most common adverse reactions reported in long-term clinical trials were dizziness (42%), nausea (30%), nystagmus (23%), confusional state (25%), gait abnormal (16%), memory impairment (13%), vision blurred (14%), headache (12%), asthenia (13%), vomiting (11%), and somnolence (10%).
Danish: De hyppigste bivirkninger rapporteret i langvarige kliniske forsøg var svimmelhed (42 %), kvalme (30 %), nystagmus (23 %), konfusionstilstand (25 %), abnorm gangart (16 %), svigtende hukommelse (13 %), sløret syn (14 %), hovedpine (12 %), asteni (13 %), opkastning (11 %) og døsighed (10 %).
English: Long-term use
Danish: Langvarig brug
English: Prialt should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Prialt bør undersøges visuelt for partikler og misfarvning inden administrationen.
English: If such is the case, you should immediately notify your doctor, as he/she may decide to halt your Prialt treatment.
Danish: Hvis dette er tilfældet, skal De straks fortælle det til Deres læge, da han/hun kan beslutte at stoppe Deres behandling med Prialt.
English: The solution should not be used if discoloured or cloudy or if particulate matter is observed.
Danish: Opløsningen bør ikke anvendes, hvis den er misfarvet eller uklar, eller hvis der observeres partikler.
English: • Anaphylactic reaction (it is not known how many people this affects) - is a severe allergic reaction, the signs of which are sudden wheeziness, difficulty in breathing, pain in the chest, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
Danish: • Anafylaktisk reaktion (det er ukendt, hvor mange personer, dette berører) - er en svær allergisk reaktion, hvor tegnene er pludselig hvæsen, åndedrætsbesvær, smerter i brystet, hævelse af øjenlåg, ansigt eller læber, udslæt og kløe (især hvis det påvirker hele kroppen).
English: Cognitive and neuropsychiatric adverse reactions
Danish: Kognitive og neuropsykiatriske bivirkninger
English: Episodes of acute psychiatric disturbances, such as hallucinations, paranoid reactions, hostility, aggressiveness, delirium, psychosis and manic reactions have been reported in patients treated with ziconotide.
Danish: Episoder med akutte psykiske forstyrrelser, såsom hallucinationer, paranoide reaktioner, fjendtlighed, aggressivitet, delirium, psykose og maniske reaktioner er blevet rapporteret hos patienter, der behandles med ziconotid.
English: In the event of progressive elevation, or clinically significant elevation in association with clinical features of myopathy or rhabdomyolysis, discontinuation of ziconotide should be considered.
Danish: I tilfælde af progressiv forhøjelse, eller klinisk signifikant forhøjelse i forbindelse med kliniske symptomer på myopati eller rabdomyolyse, bør afbrydelse af ziconotid behandlingen overvejes.
English: Elevations in creatine kinase
Danish: Forhøjede niveauer af kreatinkinase
English: Elevations in creatine kinase, which are usually asymptomatic, are common amongst patients on intrathecal ziconotide.
Danish: Forøgelser i kreatinkinase, som sædvanligvis er asymptomatiske, er almindelig hos patienter på intratekal ziconotid.
English: What Prialt contains - The active substance is ziconotide.
Danish: Prialt indeholder: - Aktivt stof: ziconotid.
English: Ziconotide may cause or worsen depression with the risk of suicide in susceptible patients.
Danish: Ziconotid kan hos modtagelige patienter forårsage eller forværre depression med risiko for selvmord.
English: No clinical data are available on the interaction between IT chemotherapy and IT ziconotide.
Danish: Der er ingen tilgængelige kliniske data vedrørende interaktion mellem IT kemoterapi og IT ziconotid.
English: Very low circulating plasma concentrations of ziconotide may be observed following IT administration due to both the low IT infusion rate and relatively rapid plasma clearance.
Danish: Meget lave cirkulerende plasma koncentrationer af ziconotid kan observeres efter IT administration på grund af både den lave IT infusionshastighed og relativt hurtige plasmaclearance.
English: Ziconotide is contraindicated in combination with IT chemotherapy (see section 4.3).
Danish: Ziconotid er kontraindiceret i kombination med IT kemoterapi (se pkt.
English: Symptoms of rhabdomyolysis are abnormal urine colour (brown coloured), reduced urine production, muscle weakness, muscle aching and muscle tenderness.
Danish: Symptomerne på rabdomyolyse er unormalt farvet urin (brunfarvet), nedsat urinproduktion, muskelsvaghed, muskelsmerter og ømme muskler.
English: If you receive more Prialt than your doctor intended, you may feel unwell with signs such as confusion, problems with speech, word finding difficulties, excessive shaking, light-headedness, excessive sleepiness, feeling or being sick.
Danish: Hvis De får mere Prialt, end Deres læge havde påtænkt, vil De muligvis føle Dem utilpas og f.eks. opleve tegn på konfusion, taleproblemer, vanskelighed ved at finde ord, overdreven rystelse, omtågethed, voldsom søvnighed, kvalme eller opkastning.
English: There were three placebo-controlled clinical trials of IT ziconotide.
Danish: Der blev udført tre placebo-kontrollerede kliniske forsøg med IT ziconotid.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ziconotide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med ziconotid skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.