FrancophonIA/ELRC3.0 huggingface dataset:
English: Before giving you Prialt, your doctor might decide to slowly stop giving you opiates (other types of medicinal product which are used to treat pain) into your spinal cord and instead replace with alternative pain medicinal products.
Danish: Før Deres læge giver Dem Prialt, vil han/hun muligvis beslutte langsomt at ophøre med at give Dem opiater (andre former for medicin, som anvendes til at behandle smerter) i rygmarven og i stedet erstatte dem med alternative smertestillende lægemidler.
English: Alternative dosing regimens including initiation of dosing with lower doses of ziconotide and bolus administration have been explored in a limited number of studies available in the literature.
Danish: Alternative doseringsregimer, herunder en påbegyndt dosering med lavere doser ziconotid og bolusadministration, er blevet undersøgt i et begrænset antal studier, som er tilgængelige i litteraturen.
English: Most patients under observation recovered within 24 hours of withdrawal of the medicinal product.
Danish: De fleste patienter under observation kom sig inden for 24 timer efter afbrydelse af lægemidlet.
English: Observations included transient and reversible neurological effects consisting of tremors, uncoordinated movements and hyper- and hypoactivity.
Danish: Observationerne omfattede transiente og reversible neurologiske virkninger, som inkluderede tremor, ukoordinerede bevægelser samt hyper- og hypoaktivitet.
English: The long-term consequences to neuronal function of continuous N-type calcium-channel block have not been demonstrated in experimental animals.
Danish: Langtidskonsekvenserne på neuronal funktion af kontinuerlig N-type calciumkanalblokker er ikke blevet påvist hos forsøgsdyr.
English: The use of Prialt has been reported to cause confusion and drowsiness.
Danish: Det er rapporteret, at brugen af Prialt kan forårsage konfusion og søvnighed.
English: General medical supportive measures should be administered to patients who receive an overdose until the exaggerated pharmacological effects of the medicinal product have resolved.
Danish: Generelle medicinske, støttende forholdsregler skal tages over for patienter, som får en overdosis, indtil de unormalt store farmakologiske virkninger af lægemidlet er opklaret.
English: Strict aseptic procedures must be used during the preparation and handling of the solution for infusion and refilling of the pump.
Danish: Der skal anvendes strenge aseptiske procedurer under klargøring og håndtering af infusionsvæsken og genopfyldning af pumpen.
English: Efficacy results from study 301
Danish: Effektresultater fra studie 301
English: The recommended starting dose is no more than 2.4 micrograms per day.
Danish: Den anbefalede startdosis er ikke mere end 2,4 mikrogram pr. dag.
English: These studies were of short duration, 5 and 6 days respectively, and used a more rapid dose escalation and higher doses than recommended in Section 4.2.
Danish: Disse studier var af kort varighed, henholdsvis 5 og 6 dage, og anvendte en hurtigere dosisøgning og højere doser end anbefalet i pkt.
English: Ziconotide did not induce bacterial gene mutation and was not genotoxic.
Danish: Ziconotid inducerede ikke bakteriel genmutation og var ikke genotoksisk.
English: Therefore, catheter tip placement should be carefully considered to allow adequate access to spinal nociceptive segments whilst minimising medicinal product concentrations at cerebral levels.
Danish: Placering af kateterspidsen bør overvejes nøje for at give tilstrækkelig adgang til spinale nociceptive segmenter, mens lægemiddelkoncentrationerne minimeres ved de cerebrale niveauer.
English: Ziconotide appears to distribute mainly within the CSF until transferred to the systemic circulation.
Danish: Ziconotid synes hovedsageligt at fordeles inde i CSF, indtil det overføres til det systemiske kredsløb.
English: You must tell your doctor immediately if you notice these serious side effects as you may require urgent medical treatment.
Danish: De skal straks fortælle det til lægen, hvis De bemærker følgende alvorlige bivirkninger, da De kan have behov for akut behandling.
English: - You may experience drowsiness or may not be fully aware of your surroundings whilst receiving treatment.
Danish: - De kan opleve døsighed eller at De ikke er helt bevidst om Deres omgivelser, mens De får behandlingen.
English: Approximately 75% of patients who respond satisfactorily to treatment require a dose of ≤ 9.6 μg/day.
Danish: Cirka 75 % af de patienter, som reagerer tilfredsstillende på behandlingen, kræver en dosis på ≤ 9,6 μg/dag.
English: Ziconotide is a peptide consisting of 25 naturally-occurring amino acids of the L-configuration, and does not appear to be appreciably metabolised in the CSF.
Danish: Ziconotid er et peptid, der består af 25 naturligt forekommende aminosyrer af L-konfiguration, og synes ikke at blive synderligt metaboliseret i CSF.
English: The optimal intrathecal placement of the catheter tip has not been established.
Danish: Den optimale intratekale placering af kateterspidsen er ikke blevet etableret.
English: Bolus administration studies suggest that bolus dosing may be useful in identifying patients who may benefit from long term use of ziconotide, however, may result in more adverse reactions than administration by continuous infusion.
Danish: Studier med bolusadministration tyder på, at en bolusdosering kan være nyttig til at identificere patienter, som kan drage fordel af en langvarig anvendelse af ziconotid, men det kan imidlertid føre til flere bivirkninger end administration med kontinuerlig infusion.
English: Prialt contains the active substance ziconotide which belongs to a group of medicines, called analgesics or ‘painkillers'.
Danish: Prialt indeholder det aktive stof ziconotid, som tilhører en gruppe lægemidler, der kaldes analgetika eller ‘smertestillende midler'.
English: Treatment with ziconotide should only be undertaken by physicians experienced in intrathecal (IT) administration of medicinal products.
Danish: Behandling med ziconotid bør kun foretages af læger med erfaring i intratekal (IT)-administration af lægemidler.
English: Not Known
Danish: Ikke almindelig Ikke kendt
English: Progressive elevation of the creatine kinase is uncommon.
Danish: Progressiv forhøjelse af kreatinkinase er usædvanlig.
English: opiate infusion dose should be gradually tapered over a few weeks and replaced with a pharmacologically equivalent dose of oral opiates.
Danish: Hos patienter, der bliver nedtrappet fra IT opiater, bør IT infusionsdosen med opiater nedsættes gradvist over en periode på nogle få uger og erstattes med en farmakologisk ækvivalent dosis af orale opiater.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar hætteglasset i den originale yderpakning for at beskytte mod lys.
English: Ziconotide has moderate influence on the ability to drive and use machines.
Danish: Ziconotid påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Pharmacotherapeutic group: Analgesics, other analgesics and antipyretics, ATC code: N02BG08
Danish: Farmakoterapeutisk klassifikation: Analgetika: Andre analgetika og antipyretika ATC-kode: N02BG08
English: Efficacy results from study 95-001
Danish: Effektresultater fra studie 95-001
English: Although ziconotide has been studied in long-term, open label efficacy and safety clinical trials, controlled studies of longer than 3 weeks duration have not been conducted (see section 5.1).
Danish: Selv om ziconotid er blevet undersøgt i langvarige, open-label kliniske forsøg vedrørende effektivitet og sikkerhed, er der ikke udført kontrollerede studier af mere end 3 ugers varighed (se pkt.
English: Postural hypotension was observed in almost all subjects who received high intravenous doses of ziconotide.
Danish: Postural hypotension blev observeret hos næsten alle forsøgspersoner, som fik høje intravenøse doser af ziconotid.
English: Warnings and precautions Talk to your doctor before you are given Prialt - The effects of long-term treatment of Prialt are uncertain at this time and the possibility of toxic effects on the spinal cord have not yet been ruled out.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før De får Prialt - Følgerne efter langvarig behandling med Prialt er usikre på nuværende tidspunkt, og risikoen for skadelig virkning på rygmarven er endnu ikke udelukket.
English: Medicinal products that affect specific peptidases/proteases would not be expected to impact upon ziconotide plasma exposure.
Danish: Lægemidler, der påvirker specifikke peptidaser/proteaser forventes ikke at have indflydelse på ziconotid plasma eksponering.
English: Very common (≥ 1/10)
Danish: Meget almindelig (≥ 1/10)
English: Ziconotide must be administered as a continuous infusion via an intrathecal catheter, using an external or internally implanted mechanical infusion pump capable of delivering an accurate infusion volume.
Danish: Ziconotid skal indgives som en kontinuerlig infusion via et intratekalt kateter ved brug af en ekstern eller en internt implanteret mekanisk infusionspumpe, som er i stand til at indgive et præcist infusionsvolumen.
English: Infections and infestations sepsis, meningitis
Danish: Infektioner og parasitære sygdomme sepsis, meningitis
English: Ziconotide is indicated for the treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia.
Danish: Ziconotid er indiceret til behandling af svær, kronisk smerte hos voksne, som kræver intratekal (IT) analgesi.
English: The plasma pharmacokinetics following intravenous doses (0.3 - 10 μg/kg/24 hr) were also studied.
Danish: Plasma farmakokinetikken efter intravenøse doser (0,310 μg/kg/24 t) blev ligeledes undersøgt.
English: However, in clinical trials it has been observed that patients who tolerate doses of 21.6 μg/day following slow titration over a 3 to 4-week period, generally tolerate higher doses up to 48.0 μg/day.
Danish: Imidlertid er det i kliniske forsøg opserveret, at patienter, som tolererer doser på 21,6 μg/dag efter langsom titrering over en 3 til 4 ugers periode, generelt tolererer højere doser op til 48,0 μg/dag.
English: The introduction of air into the pump reservoir or cartridge should be minimized, as oxygen can degrade ziconotide.
Danish: Indtrængen af luft i pumpereservoiret eller -patronen bør minimeres, da ilt kan forringe ziconotid.
English: Vomiting and anorexia, and peripheral oedema were also observed when IT ziconotide was added to IT morphine.
Danish: Opkastning og anorexi samt perifere ødemer blev ligeledes observeret, når IT ziconotid blev tilføjet til IT morfin.
English: Prialt has been shown to be chemically and physically compatible with the implantable Synchromed pump and the external CADD-Micro pump at the concentration levels indicated above.
Danish: Prialt har vist sig at være kemisk og fysisk kompatibelt med den implanterbare Synchromed pumpe og den eksterne CADD-Micro pumpe ved de koncentrationer, der er angivet ovenfor.
English: Within each frequency grouping undesirable effects are presented in order of decreasing frequency.
Danish: Inden for hver hyppighedsgruppering er bivirkningerne opstillet efter faldende hyppighed.
English: The median dose at response is approximately 6.0 μg/day and approximately 75% of responsive patients require ≤ 9.6 μg/day.
Danish: Den gennemsnitlige responsdosis er cirka 6,0 μg/dag, og cirka 75 % af de responderende patienter kræver ≤ 9,6 μg/dag.
English: How to use Prialt
Danish: Sådan skal De bruge Prialt
English: The majority had spinal pain (n = 134), especially failed back surgery (n = 110); a lower proportion had neuropathy (n = 36).
Danish: Flertallet havde smerte i rygsøjlen (n = 134), især fejlslagen rygkirurgi (n = 110); en mindre del havde neuropati (n = 36).
English: Upon reaching the systemic circulation, ziconotide appears to be more extensively distributed, based on a plasma distribution volume of approximately 30 l and is only about 53% bound (non-specifically) to human plasma proteins.
Danish: Når ziconotid når det systemiske kredsløb, synes det at blive fordelt mere ekstensivt, baseret på et plasma fordelingsvolumen på cirka 30 l, og er kun cirka 53 % bundet (non-specifikt) til humane plasma proteiner.
English: 44b 17489 Greifswald Germany
Danish: 44b 17489 Greifswald Tyskland
English: Possible long-term local toxic effects on the spinal cord have not been excluded and preclinical data in this respect are limited (see section 5.3).
Danish: Mulige langvarige lokale toksiske virkninger på rygmarven er ikke blevet udelukket, og prækliniske data vedrørende dette er begrænsede (se pkt.
English: During a convulsion, the person's muscles contract and relax repeatedly and the person may lose consciousness.
Danish: Under et krampeanfald trækker musklerne sig skiftevist sammen og afslappes, og personen kan blive bevidstløs.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke, om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De bruger dette lægemiddel.
English: NCCs regulate neurotransmitter release in specific neuronal populations responsible for the spinal processing of pain.
Danish: NCCer regulerer neurotransmitter frigørelse i specifikke neuronale populationer, som behandler smerte i rygmarven.
English: Prialt was stable for 60 days at 37°C in the Synchromed pump previously exposed to the medicinal product.
Danish: Prialt var stabil i 60 dage ved 37 °C i Synchromed pumpen, som tidligere var eksponeret for lægemidlet.
English: No data are available regarding the concomitant use of partial opioid agonists (e.g. buprenorphine) with ziconotide.
Danish: Der er ingen tilgængelige data vedrørende samtidig brug af partielle opioide agonister (f.eks. buprenorphin) og ziconotid.
English: - If you are receiving an anticancer medicine into the space around your spinal cord.
Danish: - hvis De får et kræftlægemiddel i området omkring rygmarven.
English: You may feel drowsy if you are given Prialt with certain other medicines used to treat pain.
Danish: De vil muligvis blive søvnig, hvis De får Prialt sammen med visse andre smertestillende lægemidler.
English: However, ziconotide did not induce cell transformation in the in vitro Syrian hamster embryo (SHE) assay and did not increase cell proliferation (pre-neoplastic lesion formation) or apoptosis after subchronic intrathecal exposure in dogs.
Danish: Imidlertid inducerede ziconotid ikke celletransformation i in vitro forsøg med syriske hamsterfostre (SHE) og forøgede ikke celleproliferation (præneoplastisk dannelse af læsioner) eller apoptose efter subkronisk intratekal eksponering hos hunde.
English: The safety of ziconotide administered as a continuous intrathecal infusion has been evaluated in more than 1,400 patients participating in acute and chronic pain clinical trials.
Danish: Sikkerheden af ziconotid, indgivet som en kontinuerlig intratekal infusion, er blevet evalueret hos mere end 1.400 patienter, der har deltaget i kliniske forsøg vedrørende akut og kronisk smerte.
English: The CSF pharmacokinetics of ziconotide have been studied following one-hour IT infusions of 1 - 10 μg of ziconotide in patients with chronic pain.
Danish: CSF farmakokinetikken af ziconotid er blevet studeret efter én times IT infusioner på 1 - 10 μg ziconotid hos patienter med kronisk smerte.
English: What you need to know before you are given Prialt
Danish: Det skal De vide, før De begynder at få Prialt
English: Study 301 (n = 220) was of longer duration (21 days), involved more cautious up-titration and lower doses of IT ziconotide, and enrolled the most refractory population of patients studied in the three studies.
Danish: Studie 301 (n = 220) var af længere varighed (21 dage), involverede flere forsigtige optitreringer og lavere doser intratekal ziconotid; og studiet rekrutterede den mest refraktære patientpopulation i de tre studier.
English: Though statistically significant relationships and reasonable correlation between cerebrospinal fluid (CSF) exposure (AUC, Cmax) and clinical response measures have been observed following 1 hour IT administration, no well-defined dose-concentration-response relationships have yet been identified.
Danish: Selv om der er observeret statistisk signifikant sammenhæng og rimelig korrelation mellem cerebrospinal væske (CSF) eksponering (AUC, Cmax) og målinger af klinisk respons efter 1 times IT administration, er der stadig ikke identificeret veldefinerede sammenhænge mellem dosis/koncentration og respons.
English: Type I glass vials with butyl rubber stoppers coated with fluorinated polymer.
Danish: Type I glas hætteglas med butylgummiprop belagt med fluorineret polymer.
English: Patients have experienced depressed levels of consciousness while receiving ziconotide.
Danish: Patienter har oplevet nedsat bevidsthedsniveau, mens de fik ziconotid.
English: Ear and labyrinth disorders vertigo, tinnitus
Danish: Øre og labyrint vertigo, tinnitus
English: Your treatment with Prialt will be managed by a doctor who has experience of giving medicines into the space around the spinal cord, and in the use of internal and external infusion pumps.
Danish: Deres behandling med Prialt vil blive forestået af en læge, der har erfaring i at give medicin i området omkring rygsøjlen samt i brugen af interne og eksterne infusionspumper.
English: 17493 Greifswald-Insel Riems Germany
Danish: 17493 Greifswald-Insel Riems Tyskland
English: - If you develop any tenderness in the area around the tube without signs of infection, you should seek advice from your doctor as soon as possible as tenderness may be an early sign of infection.
Danish: - Hvis der opstår ømhed i området omkring slangen uden tegn på infektion, bør De rådføre Dem med Deres læge så hurtigt som muligt, da ømhed kan være et tidligt tegn på infektion.
English: - If you are receiving chemotherapy please tell your doctor.
Danish: - Hvis De får kemoterapi, skal De underrette Deres læge herom.
English: Cognitive impairment typically appears after several weeks of treatment.
Danish: Kognitiv hæmning fremkommer normalt efter flere ugers behandling.
English: Median ziconotide CSF volume of distribution (Vd: 99 ml) is between the spinal cord CSF volume (approximately 75 ml) and total CSF volume (approximately 130 ml).
Danish: Median ziconotid CSF fordelingsvolumen (Vd: 99 ml) ligger mellem rygmarvens CSF volumen (cirka 75 ml) og totalt CSF volumen (cirka 130 ml).
English: Ziconotide may cause confusion, somnolence and other neurological adverse reactions, therefore patients must be advised not to drive or operate machines if affected.
Danish: Ziconotid kan forårsage konfusion, døsighed og andre neurologiske bivirkninger, og derfor skal patienter rådgives til ikke at føre motorkøretøj eller betjene maskiner, hvis de oplever disse symptomer.
English: - If you notice any adverse change in your thinking, mood or memory, please tell your doctor.
Danish: - Hvis De bemærker nogen uønsket ændring i Deres tænkemåde, humør eller hukommelse, bør De underrette Deres læge herom.
English: Ziconotide is a synthetic analogue of a ω-conopeptide, MVIIA, found in the venom of the Conus magus marine snail.
Danish: Ziconotid er en syntetisk analog af en ω-conopeptid, MVIIA, som findes i giften i havsneglen Conus magus.
English: The addition of IT morphine to stable doses of IT ziconotide is better tolerated (pruritis has been reported) (see section 5.1).
Danish: Tilføjelse af IT morfin til stabile doser af IT ziconotid tolereres bedre (pruritus er blevet indberettet) (se pkt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per maximum recommended intrathecal dose (21.6 μg/day), i.e. essentially ‘sodium- free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. maksimalt anbefalet intratekal dosis (21,6 μg/dag), d.v.s. den eri det væsentlige natriumfri.
English: These effects were defined by exaggerated pharmacological actions of ziconotide and not by neurotoxic lesions or target organ toxicity.
Danish: Disse virkninger blev defineret som unormalt store farmakologiske virkninger af ziconotid og ikke ved neurotoksiske læsioner eller toksicitet i målorganet.
English: If necessary the dose can be decreased by any amount (including stopping the infusion) for the management of adverse reactions.
Danish: Om nødvendigt kan dosen formindskes ved en hvilken som helst mængde (inklusive ophør med infusionen) til håndtering af bivirkninger.
English: Patients and physicians must be vigilant for typical symptoms and signs of meningitis.
Danish: Patienter og læger skal være årvågne over for typiske symptomer og tegn på meningitis.
English: As the risk of meningitis secondary to prolonged catheterisation of the intrathecal space is greater with an external catheter infusion system, internal systems are recommended to administer ziconotide for prolonged periods (see section 4.4).
Danish: Da risikoen for meningitis sekundært til langvarig kateterisation af det intratekale rum er større i forbindelse med et eksternt kateterinfusionssystem, anbefales det at anvende interne systemer til indgivelse af ziconotid i længere perioder (se pkt.
English: - If you are receiving Prialt via a pump worn outside your body, it is important you check once daily for any signs of infection at the point where the tube enters your body.
Danish: - Hvis De får Prialt via en pumpe, som De bærer uden på kroppen, er det vigtigt, at De én gang om dagen kontrollerer, om der er tegn på infektion på det sted, hvor slangen føres ind i kroppen.
English: The infusion dose rate ranged from 0.03 - 912 μg/day, with a median final dose rate of 7.2 μg/day.
Danish: Infusionsdosens hastighed varierede fra 0,03 - 912 μg/dag med en median endelig dosishastighed på 7,2 μg/dag.
English: Dosing of ziconotide should be initiated at 2.4 μg/day and titrated on an individual patient basis according to the patient's analgesic response and adverse reactions.
Danish: Dosering med ziconotid bør initieres ved 2,4 μg/dag og titreres til den enkelte patient alt efter patientens respons på den analgetiske behandling samt eventuelle bivirkningers sværhed.
English: The event may be self-limited, but ziconotide should be discontinued until the event resolves.
Danish: Hændelsen kan være selvbegrænsende, men ziconotid bør afbrydes, indtil patienten er restitueret.
English: You should not be given Prialt - If you are allergic to ziconotide or any of the other ingredients of this medicine (listed in section
Danish: De må ikke få Prialt: - hvis De er allergisk over for ziconotid eller et af de øvrige indholdsstoffer i Prialt (angivet i punkt 6).
English: In binding to these neuronal NCCs ziconotide inhibits the voltage sensitive calcium current into primary nociceptive afferents terminating in the superficial layers of the dorsal horn of the spinal cord.
Danish: Ved at binde sig til disse neuronale NCCer hæmmer ziconotid den spændingsafhængige calcium-strøm i at gå ind i de primære nociceptive afferenter, som terminerer i de superficielle lag af rygmarvens dorsale horn.
English: It is unlikely that the degradation products of ziconotide will have significant biological activity, as peptides consisting of the individual peptide loop structures have been found to have binding affinities for N-type voltage sensitive calcium channels that are several orders of magnitude lower than that of the parent (ziconotide) compound.
Danish: Det er usandsynligt, at ziconotids nedbrydningsprodukter vil have signifikant biologisk aktivitet, da peptider bestående af individuelle peptid løkke-strukturer har vist sig at have bindingsaffiniteter for N-type spændingsafhængige calciumkanaler, der er flere størrelsesordener lavere end moderstoffets (ziconotid).
English: The maximum intended intrathecal dose of ziconotide in clinical trials was 912 μg/day following upward titration over 7 days.
Danish: Den maksimalt tilsigtede intratekale dosis ziconotid i kliniske forsøg var 912 μg/dag efter stigende titrering over 7 dage.