FrancophonIA/ELRC3.0 huggingface dataset:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2.)
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Mean VASPI score at baseline in mm (SD) Mean VASPI score at end of initial titration in mm (SD) % improvement in VASPI score at end of initial titration (SD)
Danish: Middel VAS-score ved basislinien i mm (SD) Middel VAS-score ved slutningen af den initiale titrering i mm (SD) % forbedring i VAS-score ved slutningen af den initiale titrering (SD)
English: In intravenous infusion studies, healthy male volunteers received ziconotide at doses of up to 70,000 μg/day or 3,200 times the maximum recommended daily intrathecal infusion dose.
Danish: I intravenøse infusionsstudier fik raske mandlige frivillige ziconotid ved doser på op til 70.000 μg/dag eller 3.200 gange den maksimalt anbefalede daglige intratekale infusionsdosis.
English: Mean ziconotide CL (0.38 ml/min) approximates adult human CSF turnover rate (0.3 - 0.4 ml/min).
Danish: Middel ziconotid CL (0,38 ml/min) nærmer sig voksen human CSF omsætningshastighed (0,30,4 ml/min).
English: • Meningitis (may affect up to 1 in 100 people) - is inflammation of the coverings of the brain and spinal cord usually caused by an infection.
Danish: • Meningitis (kan forekomme hos op til 1 ud af 100 personer) - er en inflammation (vævsirritation) i hjernens og rygmarvens hinder og skyldes normalt en infektion.
English: To limit the occurrence of serious adverse reactions, a maximum dose of 21.6 μg/day is recommended.
Danish: For at begrænse forekomsten af alvorlige bivirkninger anbefales en maksimal dosis på 21,6 μg/dag.
English: - If you are receiving Prialt via a pump worn outside your body and any part of the infusion tubing becomes disconnected, you must contact your doctor or nurse immediately.
Danish: - Hvis De får Prialt via en pumpe, som De bærer uden på kroppen, og hvis en del af slangesystemet river sig løs, skal De omgående kontakte Deres læge eller sundhedspersonalet.
English: Prialt is supplied as a clear, colourless solution in single use vials.
Danish: Prialt leveres som en klar, farveløs opløsning i hætteglas, til engangsbrug.
English: When adding IT ziconotide to stable doses of IT morphine, as with the initiation of IT ziconotide monotherapy, the appearance of psychotic adverse reactions (e.g., hallucinations, paranoid reactions) or discontinuation due to increased adverse reactions may occur.
Danish: Når IT ziconotid tilføjes til stabile doser af IT morfin, som ved initiering af IT ziconotid monoterapi, kan der optræde psykotiske bivirkninger (f.eks. hallucinationer, paranoide reaktioner) eller afbrydelse på grund af forøget forekomst af bivirkninger (se pkt.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Disse vil normalt ikke være længere end 24 timer ved 2 °C - 8 °C, medmindre fortynding er foregået under kontrollerede og validerede aseptiske forhold.
English: An increased incidence of somnolence has been observed when ziconotide is administered concomitantly with systemic baclofen, clonidine, bupivacaine or propofol thus for the time being their simultaneous use is discouraged.
Danish: Der er observeret en øget forekomst af døsighed, når ziconotid indgives samtidig med systemisk baclofen, clonidin, bupivacain eller propofol.
English: Other medicines and Prialt
Danish: Brug af anden medicin sammen med Prialt
English: If this happens, you should immediately notify your doctor, as he/she may decide to halt your Prialt treatment.
Danish: Hvis dette sker, skal De straks fortælle det til Deres læge, da han/hun kan beslutte at stoppe Deres behandling med Prialt.
English: Administration of medicinal products by the intrathecal route carries the risk of potential serious infections, such as meningitis, which may be life threatening.
Danish: Administration af lægemidler via intratekal administration indebærer en risiko for alvorlige, potentielt livstruende infektioner, såsom meningitis.
English: Each vial contains 1, 2 or 5 ml solution for infusion.
Danish: Hvert hætteglas indeholder 1, 2 eller 5 ml infusionsvæske, opløsning.
English: - You should tell your doctor immediately if you experience any of the following symptoms after receiving your treatment; sudden wheeziness, difficulty in breathing, pain in the chest, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
Danish: - De bør straks fortælle det til Deres læge, hvis De får nogle af de følgende symptomer efter Deres behandling: pludselig hvæsen, åndedrætsbesvær, smerter i brystet, hævelse af øjenlåg, ansigt eller læber, udslæt og kløe (især hvis det påvirker hele kroppen).
English: However, monitoring of creatine kinase is recommended.
Danish: Monitorering af kreatinkinase anbefales imidlertid.
English: Prialt is used for the treatment of severe, long-term pain in adults who need a painkiller by intrathecal injection (injection into the space that surrounds the spinal cord and the brain).
Danish: Prialt anvendes til behandling af svære længevarende smerter hos voksne, som har behov for at få et smertestillende middel via intratekal injektion (injektion i området omkring rygmarven og hjernen).
English: Investigations blood creatine phosphokina se increased, weight decreased electrocardiogram abnormal, aspartate aminotransferase increased, blood creatine phosphokinase MM increased, body temperature increased a. From spontaneous reporting
Danish: Undersøgelser øget blod kreatinkinase, vægttab abnormt elektrokardiogram , øget aspartat aminotransferase, øget blod kreatinkinase MM, øget legemstemperatur a. Fra spontane rapporter
English: Low plasma exposure occurs during IT infusion due to the low recommended IT infusion rates and relatively rapid plasma clearance (see section 5.2).
Danish: Lav plasma eksponering optræder under IT infusion på grund af de anbefalede lave IT infusionshastigheder og den relativt hurtige plasma clearance (se pkt.
English: It is recommended that patients undergo a neuropsychiatric evaluation before and after starting intrathecal ziconotide (see section 4.4).
Danish: Det anbefales, at patienterne evalueres neuropsykiatrisk før og efter intratekalt ziconotid påbegyndes (se pkt.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines (for example, baclofen used to treat muscle spasticity, clonidine used to treat high blood pressure, bupivacaine used for local anaesthesia, morphine used for pain, propofol used for general anaesthesia or any medicine which is administered by intrathecal injection (injection into the space that surrounds the spinal cord and the brain)).
Danish: Fortæl altid lægen, hvis De tager anden medicin eller har gjort det for nylig (for eksempel baclofen til behandling af muskelspasticitet, clonidin til behandling af højt blodtryk, bupivacain til lokalbedøvelse, morfin mod smerter, propofol til fuld bedøvelse eller andre lægemidler, der administreres via intratekal injektion (injektion i det hulrum, der omgiver rygmarven og hjernen).
English: Studies have not been conducted in patients with impaired renal function.
Danish: Der er ikke udført studier med patienter med nedsat leverfunktion.
English: Vascular disorders orthostatic hypotensi on, hypotension
Danish: Vaskulære sygdomme ortostatisk hypotension, hypotension
English: Cognitive and neuropsychiatric adverse reactions are common in patients treated with ziconotide.
Danish: Kognitive og neuropsykiatriske bivirkninger er almindelige hos patienter, der behandles med ziconotid.
English: Cognitive and neuropsychiatric adverse reactions, particularly confusion, are common in patients treated with ziconotide.
Danish: Kognitive og neuropsykiatriske bivirkninger, især konfusion, er almindelige hos patienter behandlet med ziconotid.
English: If you receive more Prialt than you should
Danish: Hvis De har fået for meget Prialt
English: Patients and physicians must be vigilant for typical symptoms and signs of meningitis (see section 4.4).
Danish: Patienter og læger skal være på vagt over for typiske symptomer og tegn på meningitis (se pkt.
English: Two short-term studies, 95-001 (malignant pain) and 96-002 (non malignant pain), involving 366 patients, demonstrated the efficacy of IT ziconotide in severe chronic pain using the percent change in Visual Analog Scale of Pain Intensity (VASPI) as the primary efficacy measure.
Danish: To korttidsstudier, 95-001 (malign smerte), 96-002 (non-malign smerte), der involverede 366 patienter, har vist effekten af intratekal ziconotid hos patienter med svær kronisk smerte.
English: Ziconotide (n = 71)
Danish: Ziconotid (n = 71)
English: Dose at end of titration (μg/hr) Mean Median Range aResponders were defined as those who experienced a ≥ 30% drop in VASPI score compared to baseline.
Danish: Middel Median Område aRespondere blev defineret som patienter, der oplevede et ≥ 30 % fald i VAS-score sammenlignet med basislinien.
English: Ziconotide (n = 169)b
Danish: Ziconotid (n = 169)b
English: Cardiac disorders atrial fibrillation
Danish: Hjerte atriefibrillation
English: Prialt is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Prialt bør ikke anvendes under graviditeten eller til frugtbare kvinder, som ikke anvender sikker kontraception.
English: Very common (may affect more than 1 user in 10) Confusion, dizziness, blurred vision, headache, rapid back-and-forth movement of the eyes, loss or impairment of memory (forgetfulness), vomiting, nausea, general weakness and drowsiness.
Danish: Meget almindelige (kan forekomme hos mere end 1 ud af 10 personer) Konfusion, svimmelhed, sløret syn, hovedpine, hurtige frem-og-tilbage bevægelser af øjnene, hukommelsestab eller dårlig hukommelse (glemsomhed), opkastning, kvalme, generel svaghed og søvnighed.
English: • Coma (may affect up to 1 in 100 people) - a state of unconsciousness with difficulty responding or waking up.
Danish: • Koma (kan forekomme hos op til 1 ud af 100 personer) - et bevidstløshedsniveau, hvor det er svært at få et respons fra personen eller få personen til at vågne op.
English: Ziconotide is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Ziconotid bør ikke anvendes under graviditeten, eller til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: In rat fertility studies, there were no effects in males while reductions in corpora lutea; implantation sites and number of live embryos were observed in females.
Danish: I fertilitetsstudier med rotter var der ingen virkning hos hanner, mens der hos hunner blev observeret reduktion i corpora lutea, implantationssteder og antallet af levende fostre.
English: Range aResponders were defined as those patients who 1) experienced a ≥ 30% drop in VASPI score compared to baseline; 2) had stable or decreased concomitant opioid analgesics; and 3) had opiate type unchanged from preinfusion if receiving opiates.
Danish: Område aRespondere blev defineret som patienter, der 1) oplevede et ≥ 30 % fald i VAS-score sammenlignet med basislinien; 2) fik stabile eller nedsatte samtidige opioide analgetika; og 3) hvis de fik opiater før infusionen, blev de ved med at få samme type opiater.
English: PHARMACEUTICAL FORM Solution for infusion (infusion).
Danish: LÆGEMIDDELFORM Infusionsvæske, opløsning (infusion).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prialt 100 μg/ml infusion
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Prialt 100 μg/ml/infusion
English: Mean Median Range aResponders were defined as those patients who 1) experienced a ≥ 30% drop in VASPI score compared to baseline; 2) had stable or decreased concomitant opioid analgesics; and 3) had opiate type unchanged from preinfusion if receiving opiates.
Danish: Middel Median Område aRespondere blev defineret som patienter, der 1) oplevede et ≥ 30 % fald i VAS-score sammenlignet med basislinien; 2) fik stabile eller nedsatte samtidige opioide analgetika; og 3) hvis de fik opiater før infusionen, blev de ved med at få samme type opiater.
English: Symptoms of meningitis are headache, stiff neck, dislike of bright lights, fever, vomiting, confusion and drowsiness.
Danish: Symptomer på meningitis er hovedpine, nakkestivhed, utilpashed ved udsættelse for skarpt lys, feber, opkastning, forvirring og døsighed.
English: Adding IT ziconotide to stable doses of IT morphine (see section 5.1), is possible but requires special attention, as a high rate of neuropsychiatric adverse reactions (confusion/thinking abnormal, paranoid reactions and hallucinations, and abnormal gait), some of them serious, was observed in Study 202 despite a low dose of ziconotide.
Danish: 5.1) er mulig, men kræver speciel overvågning, da der i forsøg 202 blev observeret en høj forekomst af neuropsykiatriske bivirkninger (konfusion/abnorm tankemåde, paranoide reaktioner og hallucinationer samt abnorm gangart), hvoraf nogle var alvorlige på trods af en lav dosis ziconotid.
English: hydrochloric acid and sodium hydroxide.
Danish: saltsyre og natriumhydroxid
English: Respiratory, thoracic and mediastinal disorders dyspnoea respiratory distress
Danish: Luftveje, thorax og mediastinum dyspnø åndedrætsforstyrr else
English: Eye disorders vision blurred diplopia, visual disturbance, photophobia
Danish: Øjne sløret syn diplopi, synsforstyrrelse, fotofobi
English: In patients with severe chronic pain there is a higher incidence of suicide and suicide attempts than in the general population.
Danish: Hos patienter med alvorlig kronisk smerte er der en hyppigere forekomst af selvmord og selvmordsforsøg end i den generelle population.
English: Ziconotide
Danish: Ziconotid
English: Ziconotide (n = 112)
Danish: Ziconotid (n = 112)
English: Do not use this medicine if you notice any discolouration or cloudiness or if particulate matter is observed.
Danish: Brug ikke lægemidlet, hvis De bemærker misfarvning eller uklarhed eller partikler.
English: In-use shelf-life (diluted product) Chemical and physical in use stability has been demonstrated for 60 days at 37°C.
Danish: Opbevaringstid efter anbrud (fortyndet præparat) Kemisk og fysisk stabilitet er dokumenteret i 60 dage ved 37 °C.
English: Anaphylactic reactiona
Danish: Anafylaktisk reaktion
English: In some patients who received intrathecal doses greater than the maximum recommended dose, exaggerated pharmacological effects, e.g., ataxia, nystagmus, dizziness, stupor, depressed level of consciousness, muscle spasms, confusional state, sedation, hypotension, aphasia, speech disorder, nausea and vomiting were observed.
Danish: Hos nogle patienter, som fik intratekale doser større end den maksimalt anbefalede dosis, blev der observeret unormalt store farmakologiske virkninger, f.eks. ataxi, nystagmus, svimmelhed, stupor, nedsat bevidsthedsniveau, muskelspasmer, konfusionstilstand, sedation, hypotension, afasi, taleforstyrrelse, kvalme og opkastning.
English: - In patients that suffer from severe long term pain, there is a higher likelihood of suicide and attempted suicide than in the general population.
Danish: - Hos patienter, der lider af svære langvarige smerter, er der en større risiko for selvmord og selvmordsforsøg end i den generelle befolkning.
English: Marketing Authorisation Holder: RIEMSER Pharma GmbH An der Wiek 7
Danish: Indehaver af markedsføringstilladelsen: RIEMSER Pharma GmbH An der Wiek 7
English: Discontinuation of ziconotide should be considered in the event of progressive or significant elevation of creatine phosphokinase in association with clinical features of myopathy or rhabdomyolysis (see section 4.4).
Danish: Det bør overvejes at seponere ziconotid i tilfælde af stigende eller signifikant forhøjede niveauer af kreatinkinase i forbindelse med kliniske symptomer som myopati eller rabdomyolyse (se pkt.
English: In a study on male and female fertility in rats no effects in males while reductions in corpora lutea; implantation sites and number of live embryos were observed in females (see section 5.3).
Danish: I et fertilitetsstudie med han- og hunrotter blev der ikke observeret nogen virkning hos hanner, mens der blev set reduktioner i corpora lutea-implantationssteder og antallet af levende embryoer hos hunner (se pkt.
English: Monitoring of creatine phosphokinase is recommended.
Danish: Monitorering af kreatinkinase anbefales.
English: Skin and subcutaneous tissue disorders pruritus, sweating increased rash
Danish: Hud og subkutane væv pruritus, øget svedafsondring udslæt
English: Combination with IT chemotherapy (see section 4.5).
Danish: Kombination med IT kemoterapi (se pkt.
English: However, low plasma ziconotide concentrations, metabolism by ubiquitous peptidases and relatively low plasma protein binding (see section 5.2) make metabolic-based interactions or plasma protein displacement type interactions between ziconotide and other medicinal products unlikely.
Danish: 5.2) gør imidlertid metabolisme-baserede interaktioner eller interaktioner af plasma protein forskydningstypen mellem ziconotid og andre lægemidler usandsynlig.
English: Marketing Authorisation Holder RIEMSER Pharma GmbH An der Wiek 7
Danish: Indehaver af markedsføringstilladelsen RIEMSER Pharma GmbH An der Wiek 7
English: Sodium chloride Water for injections Hydrochloric acid (pH adjuster) Sodium hydroxide (pH adjuster)
Danish: Vand til injektionsvæsker Saltsyre (pH-justering) Natriumhydroxid (pH-justering)
English: Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.5).
Danish: Der skal udvises forsigtighed, når ziconotid indgives til patienter, som får systemisk kemoterapi (se pkt.
English: Gastrointestinal disorders nausea, vomiting diarrhoea, dry mouth, constipation, nausea aggravated, upper abdominal pain dyspepsia
Danish: Mave-tarm-kanalen kvalme, opkastning diaré, tør mund, forstoppelse, forværret kvalme, øvre abdominal smerte dyspepsi
English: When low doses of ziconotide are required, for example when initiating titration, ziconotide must be diluted before use with preservative-free sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Når der kræves lave doser ziconotid, som for eksempel når titreringen initieres, skal ziconotid fortyndes inden brug med ukonserveret natriumchlorid-injektionsvæske 9 mg/ml (0,9 %).
English: Caution should be exercised when ziconotide is administered to patients with impaired renal function.
Danish: Der skal derfor udvises forsigtighed, når ziconotid indgives til patienter med nedsat leverfunktion.
English: - The other ingredients (excipients) are methionine, sodium chloride, water for injections,
Danish: - Øvrige indholdsstoffer (hjælpestoffer): methionin, natriumchlorid, vand til injektionsvæsker,
English: Each vial contains 20 ml solution for infusion.
Danish: Hvert hætteglas indeholder 20 ml infusionsvæske, opløsning.
English: If needed, the dose may be decreased or injection stopped if the side effects are too great.
Danish: Hvis bivirkningerne er for store kan dosis om nødvendigt blive sat ned eller injektionen afbrudt.
English: Clear, colourless solution.
Danish: Klar, farveløs væske.
English: What Prialt is and what it is used for What you need to know before you are given Prialt How to use Prialt
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal De vide, før De begynder at få Prialt Sådan skal De bruge Prialt Bivirkninger
English: CE marked pumps equivalent to the Synchromed and CADD-Micro pump should be used to deliver Prialt.
Danish: Til indgivelse af Prialt bør der anvendes CE mærkede pumper, svarende til Synchromed og CADD-Micro pumpen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 25 μg ziconotide (as acetate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én ml opløsning indeholder 25 μg ziconotid (som acetat).
English: Renal and urinary disorders urinary retention, urinary hesitation, dysuria, urinary incontinence acute renal failure
Danish: Nyrer og urinveje urinretention, tøven ved urinering (startbesvær), dysuria, urininkontinens akut nyresvigt
English: 500 micrograms/20ml
Danish: 500 mikrogram/20 ml
English: Psychiatric disorders confusional state anxiety, auditory hallucination, insomnia, agitation, disorientation, hallucination, visual hallucination, depression, paranoia, irritability, depression aggravated, nervousness, affect lability, mental status changes, anxiety aggravated, confusion aggravated delirium, psychotic disorder, suicidal ideation, suicide attempt, thought blocking, abnormal dreams, aggressiveness
Danish: Psykiske forstyrrelser konfusionstilstand ængstelse, hørehallucinationer , insomni, agitation, desorientering, hallucinationer, visuelle hallucinationer, depression, paranoia, irritabilitet, forværret depression, nervøsitet, affektlabilitet, ændringer i mental status, forværret ængstelse, forværret konfusion delirium, psykotiske forstyrrelser, selvmordstanker, selvmordsforsøg, tankeblokering, abnorme drømme, aggressivitet
English: • Convulsions (may affect up to 1 in 100 people) - convulsions (fits) are when a person's body shakes rapidly and uncontrollably.
Danish: • Krampeanfald (kan forekomme hos op til 1 ud af 100 personer) - når kroppen ryster hurtigt og ukontrollabelt, er der tale om et krampeanfald.