FrancophonIA/ELRC3.0 huggingface dataset:
English: The vial should be allowed to stand undisturbed for 1 minute to ensure thorough hydration of the dry substance.
Danish: Hætteglasset skal have lov til at stå uforstyrret i 1 minut for at sikre grundig hydrering af det tørre stof.
English: Episodes of neutropenic fever should be monitored and managed appropriately.
Danish: Tilfælde af neutropenisk feber bør overvåges og håndteres på en hensigtsmæssig måde.
English: It has similar immunostimulatory effects as natural MDP.
Danish: Dens immunstimulerende egenskaber ligner naturlig MDP.
English: Instructions for preparation of MEPACT for intravenous infusion
Danish: Vejledning i forberedelse af MEPACT til intravenøs infusion
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket og på æsken efter ”EXP”.
English: The volume of suspension to be withdrawn for dose quantities is calculated as follows:
Danish: Den mængde suspension, der skal trækkes ud til dosismængder, beregnes på følgende måde:
English: It will be given to you twice a week (at least three days apart) for the first 12 weeks, then once a week for 24 more weeks.
Danish: Du skal behandles med MEPACT to gange om ugen (med mindst tre dages mellemrum) i de første 12 uger, derefter én gang om ugen i yderligere 24 uger.
English: The majority of these events were reported as either mild or moderate.
Danish: Hovedparten af disse tilfælde blev indberettet som værende af ”let” eller ”moderat” sværhedsgrad.
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 6 hours at room temperature.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -forhold forud for anvendelse brugerens ansvar og vil normalt ikke være længere end 6 timer ved stuetemperatur.
English: Like all medicines, MEPACT can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: There are no data from the use of mifamurtide in pregnant women.
Danish: Der er ingen data fra anvendelse af mifamurtid til gravide kvinder.
English: Mifamurtide was not mutagenic and did not cause teratogenic effects in rats and rabbits.
Danish: Mifamurtid var ikke mutagen og gav ingen teratogene virkninger hos rotter og kaniner.
English: Specific studies addressing reproductive function, perinatal toxicity and carcinogenic potential have not been performed.
Danish: Der er ikke gennemført specifikke studier, som omhandler forplantningsfunktionen, den perinatale toksicitet og det karcinogene potentiale.
English: There were no results from general toxicity studies that suggested harmful effects on male or female reproductive organs.
Danish: Ingen af de generelle toksicitetsstudier tydede på skadelige virkninger på mandlige eller kvindelige reproduktionsorganer.
English: None of the patients treated in the osteosarcoma studies were 65 years or older and in the phase III randomised study, only patients up to the age of 30 years were included.
Danish: Ingen af de patienter, der blev behandlet i studierne af osteosarkom, var 65 år eller derover, og det randomiserede fase III-studie involverede kun patienter under 30 år.
English: The exact mechanism by which mifamurtide activation of monocytes and macrophages leads to anti-tumour activity in animals and humans is not yet known.
Danish: Den præcise mekanisme, hvorved mifamurtid-aktivering af monocytter og makrofager fører til antitumor-aktivitet hos dyr og mennesker, er endnu ikke kendt.
English: Mifamurtide treatment was continued for the remainder of the study without seizure recurrence.
Danish: Mifamurtid-behandlingen fortsatte i resten af studieforløbet uden yderligere anfald.
English: Volume to withdraw = [12.5 x calculated dose (mg)] mL
Danish: Mængde, der skal trækkes ud = [12,5 x beregnet dosis (mg)] ml
English: MTP-PE is a potent activator of monocytes and macrophages.
Danish: MTP-PE er en potent aktivator af monocytter og makrofager.
English: Materials provided in each package:
Danish: Materialer leveret i hver pakke:
English: MEPACT has a moderate influence on the ability to drive and use machines.
Danish: MEPACT påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: MEPACT will be administered only under the supervision of a specialist physician.
Danish: MEPACT vil kun indgives under overvågning af en speciallæge.
English: If you stop using MEPACT
Danish: Hvis du holder op med at bruge MEPACT
English: The mean area under the curve (AUC) was 17.0 ± 4.86 h x nM and Cmax (maximum concentration) was 15.7 ± 3.72 nM.
Danish: Det gennemsnitlige areal under kurven (AUC) var 17,0 ± 4,86 t x nM, og Cmax (maksimal koncentration) var 15,7 ± 3,72 nM.
English: Mifamurtide may be given during periods of neutropenia, but subsequent fever attributed to the treatment should be monitored closely.
Danish: Mifamurtid kan gives i perioder med neutropeni, men efterfølgende feber, som tilskrives behandlingen, bør overvåges nøje.
English: Pharmacotherapeutic group: Immunostimulants, Other immunostimulants, ATC code: L03AX15
Danish: Farmakoterapeutisk klassifikation: Immunostimulanter, andre immunostimulanter, ATC-kode: L03AX15.
English: Metabolism of liposomal MTP-PE has not been studied in humans.
Danish: Metaboliseringen af liposomal MTP-PE er ikke blevet undersøgt hos mennesker.
English: In 2 of 4 patients with lung metastases, radioactivity was associated with lung metastases.
Danish: I 2 ud af 4 patienter med lungemetastaser blev radioaktivitet forbundet med lungemetastaser.
English: All patients received a total dose of cisplatin of 480 mg/m2 as part of their induction (neoadjuvant) and/or maintenance (adjuvant) chemotherapy regimen.
Danish: Alle patienter fik en total dosis cisplatin på 480 mg/m som en del af deres induktions- (neoadjuvant) og/eller vedligeholdelses- (adjuvant) kemoterapiregime.
English: Inflammatory response
Danish: Inflammatorisk respons
English: Do not use MEPACT: - if you are allergic to mifamurtide or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke MEPACT: - hvis du er allergisk (overfølsom) over for mifamurtid eller et af de øvrige indholdsstoffer i MEPACT (angivet i punkt 6).
English: MEPACT contains the active substance mifamurtide, similar to a component of the cell wall of certain bacteria.
Danish: MEPACT indeholder det aktive stof mifamurtid, der ligner en komponent i cellevæggen hos visse bakterier.
English: If a severe respiratory reaction occurs, administration of mifamurtide should be discontinued and appropriate treatment initiated.
Danish: Hvis der forekommer en svær respiratorisk reaktion, skal indgivelse af mifamurtid afbrydes, og en passende behandling igangsættes.
English: You do not need to be hospitalised to receive MEPACT.
Danish: Du skal ikke være indlagt for at få MEPACT.
English: Based on the liposomal nature of the product, use of an infusion set with an in-line filter during administration is not recommended.
Danish: Grundet produktets liposomale beskaffenhed, frarådes brug af infusionsset med in-line filter under administrationen.
English: MEPACT is a liposomal formulation specifically designed for in vivo targeting to macrophages by intravenous infusion.
Danish: MEPACT er en liposomal formulering, der er specifikt lavet til in vivo målrettet mod makrofager ved intravenøs infusion.
English: In sensitive species (rabbit and dog) the highest daily dose of liposomal mifamurtide that did not cause adverse effects was 0.1 mg/kg, corresponding to 1.2 and 2 mg/m2, respectively.
Danish: I følsomme arter (kanin og hund) resulterede den højeste daglige dosis af liposomal mifamurtid i ingen bivirkninger, 0,1 mg/kg, svarende til henholdsvis 1,2 og 2 mg/m2.
English: The liposomal suspension is infused intravenously over about 1 hour.
Danish: Den liposomale suspension infunderes intravenøst i ca. 1 time.
English: Materials provided in each package
Danish: Materialer leveret i hver pakke
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg er utilstrækkelige med hensyn til reproduktionstoksicitet (se pkt.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af Modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: MEPACT is used to treat osteosarcoma (bone cancer) in children, adolescents and young adults (between 2 and 30 years).
Danish: MEPACT anvendes til at behandle osteosarkom (knoglecancer) hos børn, unge under 18 år og unge voksne (mellem 2 og 30 år).
English: Not known (cannot be estimated from the available data): - abnormal accumulation of fluid around the heart (pericardial effusion)
Danish: Ikke kendt(kan ikke beregnes ud fra tilgængelige data): kan ikke estimeres ud fra forhåndenværende data - unormal ophobning af væske omkring hjertet (perikardieekssudat)
English: if you have a history of inflammatory or autoimmune disease or have been treated with corticosteroids or other medicines that may affect your immune system.
Danish: - hvis du har haft en betændelsesagtig eller autoimmun sygdom eller er blevet behandlet med kortikosteroider eller anden medicin, som kan påvirke dit immunsystem.
English: It is used after you have had surgery to remove the tumour and together with chemotherapy to kill remaining cancer cells to reduce the risk of cancer coming back.
Danish: Det anvendes sammen med kemoterapi, efter du har fået fjernet svulsten, for at dræbe de resterende cancerceller og nedsætte risikoen for, at canceren kommer tilbage.
English: - corticosteroids, used to treat inflammations, allergies or asthma.
Danish: - kortikosteroider, der bruges til behandling af betændelse, allergier eller astma.
English: It should be administered as adjuvant therapy following resection: twice weekly at least 3 days apart for 12 weeks, followed by once-weekly treatments for an additional 24 weeks for a total of 48 infusions in 36 weeks.
Danish: Lægemidlet bør gives som supplerende behandling efter resektion: to gange om ugen med mindst 3 dages mellemrum i 12 uger, efterfulgt af behandlinger én gang om ugen i yderligere 24 uger, det vil sige i alt 48 infusioner på 36 uger.
English: Pharmacokinetic variability was higher in the moderate hepatic impairment group (co-efficient of variation in systemic exposure [AUCinf] was 50% versus < 30% in the other hepatic function groups).
Danish: Variabiliteten i farmakokinetikken var højere i gruppen med moderat leverinsufficiens (variationskoefficienten for systemisk eksponering [AUCinf] var 50 % versus < 30 % i de andre leverfunktionsgrupper).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for mifamurtide, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for mifamurtid er CHMP nået frem til følgende videnskabelige konklusioner:
English: Although these studies are not conclusive, there is no evidence of interference of mifamurtide with the anti-tumour effects of chemotherapy and vice versa.
Danish: Selv om disse studier ikke er fyldestgørende, er der ingen tegn på interferens mellem mifamurtid og kemoterapiens antitumor-virkninger eller omvendt.
English: These are not expected at the recommended dose, however monitoring of clotting parameters after the first dose and once again after several doses is recommended.
Danish: Blødninger forventes ikke ved den anbefalede dosis, men det anbefales at overvåge koagulationsparametrene efter den første dosis og igen efter flere doser.
English: INFORMATION IN BRAILLE
Danish: INFORMATIONER I BRAILLESKRIFT
English: MTP-PE is a specific ligand of NOD2, a receptor found primarily on monocytes, dendritic cells and macrophages.
Danish: MTP-PE er en specifik ligand af NOD2, en receptor, der primært findes i monocytter, dendritiske celler og makrofager.
English: Frequency category Adverse reaction (preferred term)
Danish: Bivirkning (foretrukken term)
English: This includes medicines that may be obtained without a prescription.
Danish: Dette gælder også medicin, som ikke er købt på recept.
English: Takeda France SAS Immeuble Pacific 11-13 Cours Valmy 92800 - Puteaux France
Danish: Takeda France SAS Immeuble Pacific 11-13 Cours Valmy 92800 - Puteaux Frankrig
English: Many of the very commonly reported adverse reactions as shown in the following summary table are thought to be related to the mechanism of action of mifamurtide (see table 1).
Danish: Mange af de hyppigst indberettede bivirkninger, som er vist i nedenstående tabel, menes at være relateret til mifamurtids virkningsmekanisme (se tabel 1).
English: The safety of liposomal mifamurtide has been assessed in more than 700 patients with various kinds and stages of cancer and in 21 healthy adult subjects (see section 4.8).
Danish: Sikkerheden ved liposomal mifamurtid er blevet vurderet hos over 700 patienter med forskellige typer og stadier af cancer og hos 21 raske voksne forsøgspersoner (se pkt.
English: If symptoms are persistent and worsening, administration should be delayed or discontinued.
Danish: Hvis symptomerne bliver ved eller forværres, bør indgivelsen udsættes eller afbrydes.
English: One serious incident of subacute thrombosis was reported in early studies, but no serious cardiac events were associated with mifamurtide in a large randomised controlled study (see section 4.4).
Danish: Et alvorligt tilfælde af subakut trombose blev rapporteret i tidligere studier, men ingen alvorlige hjertetilfælde blev forbundet med mifamurtid i et stort randomiseret kontrolleret studie (se pkt.
English: On the basis of the scientific conclusions for mifamurtide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mifamurtide is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for mifamurtid er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder mifamurtid forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis (see section 5.1).
Danish: Produktets sikkerhed og effekt er blevet vurderet i studier af patienter, der var 2 til 30 år ved den indledende diagnose (se pkt.
English: Mifamurtide treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of osteosarcoma.
Danish: Behandling med mifamurtid bør iværksættes og overvåges af speciallæger med erfaring inden for diagnosticering og behandling af osteosarkom.
English: There was also one report of a grade 4 allergic reaction (hypertension) requiring hospitalization in the phase III study (see section 4.4).
Danish: Der blev derudover rapporteret et tilfælde af grad 4 allergisk reaktion (hypertension), som krævede hospitalsindlæggelse i fase III studiet (se pkt.
English: Contact your doctor immediately: - if you have continuing fever or chills more than 8 hours after your dose of MEPACT,
Danish: Kontakt straks din læge: - hvis du har feber eller kuldegysninger, som fortsætter i mere end 8 timer efter din behandling med MEPACT.
English: It can also be administered as an outpatient.
Danish: Du kan også få det som ambulant patient.
English: In a phase I study, there was one report of severe allergic reaction occurring after the first infusion of mifamurtide at 6 mg/m dose level.
Danish: I et fase I studie blev der rapporteret et tilfælde af alvorlig allergisk reaktion som fandt sted efter første infusion med mifamurtid i en dosis på 6 mg/m2.
English: - Non-steroidal-anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, or diclofenac, used for treatment of headaches, fever or pain.
Danish: - non-steroide antiinflammatoriske lægemidler (NSAID = non-steroidal-anti-inflammatory drugs) som acetylsalicylsyre, ibuprofen eller diclofenac, som bruges til behandling af hovedpine, feber eller smerter.
English: Although hearing loss may be attributable to ototoxic chemotherapy, like cisplatin, it is unclear whether MEPACT in conjunction with multi-agent chemotherapy may increase hearing loss.
Danish: Selv om tab af høreevne kan tilskrives ototoksisk kemoterapi som cisplatin, er det uklart, om MEPACT i forbindelse med multi-kemoterapi kan forværre høretabet.
English: • 2 medium (18) gauge sterile injection needles
Danish: • 2 mellemstore (18)-gauge sterile kanyler til injektion
English: These are typically mild to moderate and transient and can usually be treated by your doctor, e.g. with paracetamol for fever.
Danish: Disse er typisk lette til moderate og forbigående, og de kan som regel behandles af din læge, f.eks. med Paracetamol til feber.
English: The majority of patients experience chills, fever and fatigue especially during the first administration of MEPACT.
Danish: De fleste patienter oplever kuldegysninger, feber og træthed, specielt efter første behandling med MEPACT.
English: abdomen, arm or leg - cough, trouble breathing or rapid breathing - low body temperature - low number of red blood cells
Danish: arme eller ben - hoste, åndedrætsbesvær eller hurtig puls - lav kropstemperatur - lavt antal røde blodceller
English: Vertigo, Tinnitus, Hearing loss
Danish: Vertigo, tinnitus, høretab
English: OUTER PACKAGING
Danish: UDVENDIG EMBALLAGE
English: After injection of radiolabelled liposomes containing mifamurtide, mean half-life of radiolabelled material was biphasic with an α-phase of about 15 minutes and a terminal half-life of approximately 18 hours.
Danish: Efter injektion af radioaktivt mærkede liposomer, der indeholdt mifamurtid, var halveringstiden af det radioaktivt mærkede materiale bifasisk med en α-fase på ca. 15 minutter og en terminal halveringstid på ca. 18 timer.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of mifamurtide therapy to the woman.
Danish: En beslutning om fortsættelse/afbrydelse af amning/behandling bør tages ud fra en vurdering af barnets fordele af amning og kvindens fordele af mifamurtid-behandling.
English: The maximum tolerated dose in phase I studies was 4-6 mg/m with a high variability of adverse reactions.
Danish: Den maksimalt tolererede dosis i fase I-studierne var 4-6 mg/m med meget varierende bivirkninger.
English: Oedema, chest discomfort, local infusion or catheter site reactions and ‘feeling cold' were less frequently reported in these patients, mostly with late stage malignant disease.
Danish: Ødemer, ubehag i brystet, reaktioner på lokal infusion eller på kateterstedet og ‘kuldefølelse' blev indberettet mindre hyppigt hos disse patienter, som primært var i de sene stadier af en ondartet sygdom.
English: if you develop chills or shivering, or feel warm.
Danish: - hvis du har oplevet kuldegysninger, kulderystelser eller føles varm.
English: The reconstituted, filtered and diluted suspension for infusion is a homogenous, white to off-white, opaque liposomal suspension, free of visible particles and free of foam and lipid lumps.
Danish: Den rekonstituerede, filtrerede og fortyndede suspension til infusion er en homogen hvid til off-white uigennemsigtig liposomal suspension uden synlige partikler, uden skum og uden lipidpartikler.
English: Mifamurtide (muramyl tripeptide phosphatidyl ethanolamine, MTP-PE) is a fully synthetic derivative of muramyl dipeptide (MDP), the smallest naturally-occurring immune stimulatory component of cell walls from Mycobacterium sp.
Danish: Mifamurtid (muramyl tripeptid phosphatidyl ethanolamin, MTP-PE) er et fuldkommen syntetisk middel fra muramyl dipeptid (MDP), den mindste, naturligt forekommende immunstimulerende cellevægskomponent fra Mycobacterium sp.
English: *fully synthetic analogue of a component of Mycobacterium sp. cell wall.
Danish: *helt syntetisk analog til en komponent i cellevæggen i Mycobacterium sp.
English: During mifamurtide administration, patients should be monitored for unusual signs or symptoms, such as arthritis or synovitis, suggestive of uncontrolled inflammatory reactions.
Danish: Under indgivelsen af mifamurtid bør patienterne overvåges med henblik på usædvanlige tegn eller symptomer som artritis eller synovitis, som kan være tegn på ukontrollerede inflammatoriske reaktioner.
English: BSA-normalised clearance and half-life were similar across the age range and consistent with that determined in healthy adult subjects, supporting the recommended dose of 2 mg/m
Danish: BSA-normaliseret clearance og halveringstid var sammenlignelige over hele aldersintervallet og svarede til de værdier, der er fastlagt hos raske voksne forsøgsdeltagere, hvilket understøtter den anbefalede dosis på 2 mg/m
English: Cyanosis, Palpitations
Danish: Cyanose, palpitationer
English: Mifamurtide is, therefore, not expected to interact with the metabolism of substances that are hepatic cytochrome P450 substrates.
Danish: Mifamurtid forventes derfor ikke at interagere med metabolismen af stoffer, der er substrater for hepatisk cytokrom P450.
English: It should be used with caution in patients with a history of autoimmune, inflammatory or other collagen diseases.
Danish: Produktet bør anvendes med forsigtighed til patienter med tidligere tilfælde af autoimmune, inflammatoriske eller andre kollagene sygdomme.
English: Dehydration, Hypokalaemia, Decreased appetite
Danish: Dehydrering, hypokaliæmi, nedsat appetit
English: Gastrointestinal toxicity may be exacerbated when mifamurtide is used in combination with high dose, multi-agent chemotherapy and was associated with an increased use of parenteral nutrition.
Danish: Den gastrointestinale toksicitet kan forværres, hvis mifamurtid anvendes i kombination med højdosis kombinationskemoterapi, og blev sammenkædet med en øget anvendelse af parenteral ernæring.
English: It is used in combination with post-operative multi-agent chemotherapy.
Danish: Midlet anvendes i kombination med post-operativ kombinationskemoterapi.
English: In a separate study in 14 patients, mean serum concentration-time curves of total and free mifamurtide that were assessed after the first infusion of mifamurtide and after a last infusion 11 or 12 weeks later, were almost superimposable and the mean AUC values of the free mifamurtide after the first and last infusion were similar.
Danish: I et særskilt studie af 14 patienter var de gennemsnitlige tidskurver for serumkoncentration af total og fri mifamurtid, der blev vurderet efter den første infusion af mifamurtid og efter en sidste infusion 11 eller 12 uger senere, næsten sammenfaldende, og de gennemsnitlige AUC-værdier af den fri mifamurtid efter første og sidste infusion var ens.
English: A healthy adult volunteer accidentally received a single dose of 6.96 mg mifamurtide and experienced a reversible treatment-related event of orthostatic hypotension.
Danish: En rask voksen frivillig forsøgsperson fik ved en fejltagelse en enkelt dosis mifamurtid på 6,96 mg og oplevede behandlingsrelateret reversibel ortostatisk hypotension.
English: Because mifamurtide acts through stimulation of the immune system, the chronic or routine use of corticosteroids should be avoided during treatment with mifamurtide.
Danish: Da mifamurtid agerer gennem stimulering af immunsystemet, bør kronisk eller rutinemæssig brug af kortikosteroider undgås under behandlingen med mifamurtid.
English: White to off-white homogeneous cake or powder.
Danish: Hvidt eller offwhite homogent pulver.