FrancophonIA/ELRC3.0 huggingface dataset:
English: • In view of the available data the Committee concluded, subject to the amendments to the product information and implementation of the risk minimisation measures, that the benefitrisk balance of metoclopramide-containing products:
Danish: • i betragtning af de foreliggende data konkluderede udvalget, at under forudsætning af følgende ændringer af produktinformationen og risikominimeringsforanstaltninger er benefit/risk-forholdet for produkter indeholdende metoclopramid:
English: There appears to be no pharmacokinetic data on multiple-dosing, nor is there comparative data for different levels of hepatic impairment.
Danish: Der synes ikke at foreligge farmakokinetiske data om gentagen dosering, og der er heller ingen sammenlignende data for leverfunktionsnedsættelse af forskellig grad. I mangel af sådanne data kan der ikke fremsættes særlige anbefalinger for leverfunktionsnedsættelse af lavere grader.
English: While it is difficult to conclude on absolute efficacy of metoclopramide in these individual settings, when taken together, the data are indicative of an effect on nausea and vomiting of different aetiologies.
Danish: Det er vanskeligt at drage konklusioner om den absolutte virkning af metoclopramid i hvert af disse scenarier, men tilsammen viser dataene, at metoclopramid har virkning på kvalme og opkastning af forskellig årsag.
English: • Only the intravenous formulations remain approved for use in paediatric patients >1 year of age, and only for the indication ‘treatment of postoperative nausea and vomiting';
Danish: • Kun de intravenøse formuleringer skal fortsat være godkendt til pædiatriske patienter >1
English: • The Committee considered that metoclopramide is associated with a risk of serious adverse events, including neurological adverse events such as extrapyramidal symptoms and irreversible tardive dyskinesia.
Danish: • udvalget tog i betragtning, at metoclopramid er forbundet med risiko for alvorlige neurologiske bivirkninger såsom akutte ekstrapyramidale symptomer og irreversibel tardiv dyskinesi.
English: Thus, for both treatment of established post-operative nausea and vomiting and prevention of delayed CINV in children, the use of metoclopramide should be reserved as a second line option.
Danish: Til indikationerne behandling af manifest postoperativ kvalme og opkastning og forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning hos børn bør metoclopramid derfor kun være andetvalgsbehandling.
English: • Gastroesophageal reflux disease (GORD) and dyspepsia
Danish: • Gastroøsofagealt reflukssygdom og dyspepsi
English: Nausea and vomiting of other origins
Danish: Kvalme og opkastning af andre årsager
English: Based on data submitted, when administered for highly emetic chemotherapy, metoclopramide appears to be effective by intravenous route at doses ranging from 6 to 10 mg/kg/day.
Danish: De forelagte data synes at vise, at metoclopramid er effektivt ved stærkt emetisk kemoterapi, når det gives intravenøst i doser fra 6 til 10 mg/kg/dag.
English: • Nausea and vomiting of other origins
Danish: • Kvalme og opkastning af andre årsager
English: o Is favourable in adults for ‘prevention of post-operative nausea and vomiting' (parenteral route only)
Danish: o positivt hos voksne til “forebyggelse af postoperativ kvalme og opkastning” (kun parenteral administration)
English: Gastroesophageal reflux disease and dyspepsia
Danish: Gastroøsofageal reflukssygdom og dyspepsi
English: While endorsing the conclusions of the previous assessment, the CHMP also took note of the fact that, in particular for the treatment of delayed CINV which can be quite a debilitating condition, there are limited alternative treatments available for the paediatric population.
Danish: CHMP tilsluttede sig konklusionerne fra den tidligere vurdering, men noterede sig desuden, at der hos den pædiatriske population kun findes begrænsede behandlingsalternativer, navnlig ved forsinket kemoterapiinduceret kvalme og opkastning, som kan være en invaliderende tilstand.
English: o Is favourable in adults for ‘prevention of radiotherapy induced nausea and vomiting' (parenteral, oral and rectal routes)
Danish: o positivt hos voksne til “forebyggelse af stråleterapiinduceret kvalme og opkastning” (ved parenteral, oral og rektal administration)
English: Efficacy data
Danish: Data vedrørende virkning
English: Therefore the Committee considered that the benefit-risk balance of metoclopramide in these indications is negative.
Danish: Udvalget konkluderede derfor, at benefit/risk-forholdet for <X> til disse indikationer er negativt.
English: Therefore the Committee considered that, based on long term experience of use and the clinical need for treatment options in the paediatric population, the benefit-risk balance of metoclopramide for the prevention of delayed CINV in the paediatric population can be considered positive.
Danish: Udvalget fandt derfor, at benefit/risk-forholdet kan anses for positivt for metoclopramid til forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning hos den pædiatriske population baseret på de langvarige erfaringer med anvendelsen og det kliniske behov for behandlingsmuligheder til den pædiatriske population.
English: • Nausea and vomiting associated with migraine
Danish: • Kvalme og opkastning ved migræne
English: o Is favourable in children between 1 and 18 years of age for ‘treatment of established post-operative nausea and vomiting, as second line option' (parenteral route only)
Danish: o positivt hos børn mellem 1 og 18 til “som andetvalgsbehandling af manifest postoperativ kvalme og opkastning” (kun parenteral administration)
English: In respect of dose adjustment for renal and hepatic impairment, while it is correct that oral liquid formulations offer advantage over solid pharmaceutical forms, higher concentrations (such as 4
Danish: I forbindelse med dosisjustering ved nedsat nyrefunktion og leverfunktion er det korrekt, at orale flydende formuleringer har en fordel frem for faste lægemiddelformer, men højere koncentrationer (såsom 4 mg/ml) har ingen yderligere fordel i forhold til den foreslåede koncentration på 1 mg/ml.
English: The data presented is indicative of the efficacy of metoclopramide in acute migraine induced nausea and vomiting based on its anti-emetic properties.
Danish: De forelagte data viser, at metoclopramid som følge af sine antiemetiske egenskaber har virkning ved kvalme og opkastning ved akut migræne.
English: o Is favourable in adults for ‘prevention of delayed chemotherapy induced nausea and vomiting' (oral and rectal routes)
Danish: o positivt hos voksne til “forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning” (ved oral og rektal administration)
English: Nausea and vomiting associated with migraine
Danish: Kvalme og opkastning ved migræne
English: o Is favourable in children between 1 and 18 years of age for ‘prevention of delayed chemotherapy induced nausea and vomiting, as second line option' (parenteral and oral routes)
Danish: o positivt hos børn mellem 1 og 18 år til “som andetvalg til forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning” (ved parenteral og oral administration)
English: Very limited information exists to support the efficacy of metoclopramide in the paediatric population, in the majority of the indications.
Danish: For størstedelen af indikationerne foreligger der kun meget begrænsede data om virkningen af metoclopramid hos den pædiatriske population.
English: Radiotherapy induced nausea and vomiting
Danish: Stråleterapiinduceret kvalme og opkastning
English: • Chemotherapy or radiotherapy induced nausea and vomiting (CINV or RINV)
Danish: • Kemoterapi- eller stråleterapiinduceret kvalme og opkastning
English: The studies assessed seem to indicate that metoclopramide reduces gastric transit time, but this did not affect the time taken to complete the examination.
Danish: De vurderede undersøgelser synes at vise, at metoclopramid afkorter den gastriske passagetid.
English: Chemotherapy induced nausea and vomiting
Danish: Forsinket kemoterapiinduceret kvalme og opkastning
English: Very limited high quality data exists in support of the efficacy of metoclopramide in the majority of the indications authorised in the European Union.
Danish: For størstedelen af de i EU godkendte indikationer foreligger der kun meget begrænsede data af høj kvalitet om virkningen af metoclopramid.
English: o Is not favourable in children under 1 year of age for any indication.
Danish: o ikke er positivt hos børn under 1 år, uanset indikation o ikke er positivt til “forebyggelse af akut kemoterapiinduceret kvalme og opkastning”
English: In this population, and based on the studies submitted, the clearance of metoclopramide has shown to be significantly impaired.
Danish: Der er påvist væsentligt nedsat clearance af metoclopramid hos denne population i de forelagte undersøgelser.
English: • Post-operative nausea and vomiting (PONV)
Danish: • Postoperativ kvalme og opkastning
English: 31 January 2020
Danish: 31. januar 2020
English: Such reactions may be allergic.
Danish: Sådanne reaktioner kan være allergiske.
English: 86.4 % of the patients were Caucasian.
Danish: 86,4 % af patienterne var kaukasiere.
English: The pain can last from few days to up to 200 days.
Danish: Smerten kan have en varighed fra få dage og op til 200 dage.
English: • Monitor patient for worsening of condition.
Danish: • Monitorer patienten for forværring af tilstanden.
English: The median age was 58 years with 42 patients ≥ 65 years of age.
Danish: Medianalderen var 58 år med 42 patienter ≥ 65 år.
English: This corresponds to a mean terminal half-life of approximately 11 days.
Danish: Dette svarer til en gennemsnitlig terminal halveringstid på ca. 11 dage.
English: Your doctor will discuss this with you.
Danish: Lægen vil tale med dig om dette.
English: The following convention has been used for classification of frequency: Very common (≥ 1/10)
Danish: Følgende konvention er brugt til klassificering af hyppigheden: Meget almindelig (≥ 1/10)
English: Frequency overall Grade 3/4 frequency
Danish: Grad 3/4 hyppighed
English: Subgroups analysis of OS is shown in figure 2.
Danish: Subgruppeanalysen af OS er vist i figur 2.
English: The following side effects have been reported:
Danish: Der er rapporteret følgende bivirkninger:
English: Storage times include the duration of infusion.
Danish: Opbevaringstiderne omfatter også varigheden af infusionen.
English: The drip lasts about 60 minutes.
Danish: Infusionen varer ca. 60 minutter.
English: The safety and efficacy of olaratumab in children aged 0 to 18 years of age have not yet been established.
Danish: Olaratumabs sikkerhed og virkning hos børn i alderen 0-18 år er endnu ikke klarlagt.
English: Clearance and volume of distribution had a positive correlation with body weight.
Danish: Clearance og fordelingsvolumen havde en positiv korrelation med kropsvægt.
English: The current wording of the Package leaflet is considered sufficient to communicate this risk.
Danish: Den nuværende ordlyd i indlægssedlen er vurderet tilstrækkelig for kommunikation af denne risiko.
English: Doxorubicin alone (n = 67)
Danish: Doxorubicin alene (n = 67)
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakninger er nødvendigvis markedsført.
English: Other symptoms may occur as well (see section 2 “Warnings and precautions”).
Danish: Der kan også forekomme andre symptomer (se afsnit 2 ”Advarsler og forsigtighedsregler”).
English: White blood cells are important for fighting infection.
Danish: Hvide blodlegemer er vigtige for bekæmpelse af infektioner.
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Danish: Lægen vil tale med dig om disse bivirkninger og vil forklare risiciene og fordelene ved behandlingen.
English: Management recommendations (any occurrence)
Danish: Anbefalinger til håndtering (enhver forekomst)
English: Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity.
Danish: Immunogenicitet I lighed med alle andre terapeutiske proteiner er der mulighed for immunogenicitet.
English: Lartruvo should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Danish: Patienter under 18 år må ikke få Lartruvo, da der ikke findes information om, hvordan lægemidlet virker hos denne aldersgruppe.
English: The study met its primary endpoint (PFS).
Danish: I studiet blev det primære endepunkt (PFS) nået.
English: The number of infusions that you receive will depend on how well and for how long treatment with Lartruvo works and how well you feel.
Danish: Antallet af infusioner, som du får, vil afhænge af, hvor godt og hvor længe behandlingen med Lartruvo virker, og hvor godt du har det.
English: The final total volume in the container should be 250 mL.
Danish: Det endelige samlede volumen i beholderen skal være 250 ml.
English: It is not known if Lartruvo will affect your ability to drive.
Danish: Det vides ikke, om Lartruvo vil påvirke din evne til at føre motorkøretøj.
English: See section 4 for more details about infusion-related reactions which may occur during or after the infusion.
Danish: Se afsnit 4 for yderligere oplysninger om de infusionsrelaterede reaktioner, der kan opstå under eller efter infusionen.
English: The main analysis was performed in the following two subgroups: Leiomyosarcoma (LMS) and non-LMS (other).
Danish: Den primære analyse blev foretaget i følgende to subgrupper: Leiomyosarkom (LMS) og ikke-LMS (andre).
English: Doxorubicin can cause cardiotoxicity.
Danish: Doxorubicin kan forårsage kardiotoksicitet.
English: The majority of these events occurred in the first 4 cycles.
Danish: Hovedparten af disse bivirkninger indtrådte i løbet af de første 4 serier.
English: Tell your doctor or nurse immediately if you feel unwell during infusion.
Danish: Fortæl straks lægen eller sygeplejersken, hvis du føler dig utilpas under infusionen.
English: PFS according to a post-hoc, blinded, independent assessment was 8.2 months vs 4.4 months; HR = 0.670; p = 0.1208.
Danish: Ifølge en post-hoc blindet, uafhængig bestemmelse var PFS 8,2 måneder vs. 4,4 måneder; HR = 0,670; p = 0,1208.
English: Other subtypes were infrequently represented.
Danish: Andre undertyper var uregelmæssigt repræsenteret.
English: If you get any symptoms that affect your ability to concentrate and react, such as tiredness, do not drive or use machines until the effect goes away.
Danish: Hvis du får bivirkninger, der påvirker din evne til at koncentrere dig og reagere, såsom træthed, må du ikke køre motorkøretøj eller betjene maskiner, før virkningen er forsvundet.
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk. 7, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: The primary efficacy outcome measure was progression free survival (PFS) by investigator assessment.
Danish: Det primære virkningsmål var progressionsfri overlevelse (PFS) baseret på investigators vurdering.
English: Store in a refrigerator (2° C - 8° C).
Danish: Opbevares i køleskab (2°C - 8°C).
English: The majority of these reactions occurred during or following the first olaratumab infusion.
Danish: Størstedelen af disse reaktioner opstod under eller efter den første infusion af olaratumab.
English: Parenteral medicines should be inspected visually for particulate matter prior to administration.
Danish: Parenterale lægemidler skal kontrolleres visuelt for partikler før administration.
English: Efficacy results are shown in Table 3 and Figures 1 and 2.
Danish: Effektresultaterne er vist i tabel 3 og figur 1 og figur 2.
English: Talk to your doctor or nurse immediately if the following applies to you (or you are not sure):
Danish: Kontakt omgående lægen eller sundhedspersonalet, hvis følgende gælder for dig (eller hvis du er i tvivl):
English: • Additional risk minimisation measures
Danish: • Yderligere risikominimeringsforanstaltninger Ikke relevant
English: PDGFR-α is found in large amounts on some cancer cells where it stimulates the cells to grow and divide.
Danish: PDGFR-α findes i store mængder på visse kræftceller, hvor det stimulerer cellerne til at vokse og dele sig.
English: Infusion solution: After dilution and preparation, the medicine must be used immediately.
Danish: Infusionsvæske: Efter fortynding og klargøring skal lægemidlet anvendes med det samme.
English: Toxicity in the elderly
Danish: Toksicitet hos ældre
English: Below is a list of some typical symptoms associated with infusion reactions:
Danish: Nedenfor er en liste over typiske symptomer på en infusionsreaktion:
English: Patients had received 0-4 previous lines of therapy for treatment of advanced disease but had not previously received treatment with anthracyclines.
Danish: Patienterne havde fået 0-4 tidligere behandlingslinjer for fremskreden sygdom, men var ikke tidligere blevet behandlet med antracykliner.
English: Date of latest renewal: 21 September 2017
Danish: Dato for første markedsføringstilladelse: 9. november 2016 Dato for seneste fornyelse: 21. september 2017
English: All severe IRRs occurred during or immediately after the first administration of olaratumab.
Danish: Alle svære IRR'er opstod under eller umiddelbart efter den første administration af olaratumab.
English: L-Histidine monohydrochloride monohydrate L-Histidine
Danish: L-histidinmonohydrochloridmonohydrat L-histidin
English: Name and address of the manufacturer(s) of the biological active substance(s) ImClone Systems LLC
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof ImClone Systems LLC
English: Key secondary efficacy outcome measures were overall survival (OS) and objective response rate (ORR) (see Table 3).
Danish: De vigtigste sekundære virkningsmål var samlet overlevelse (OS) og objektiv responsrate (ORR) (se tabel 3).
English: Lartruvo contains sodium
Danish: Lartruvo indeholder natrium
English: In order to accommodate larger infusion volumes that may be needed for patients requiring higher doses, the duration of infusion should be increased such that the maximum infusion rate of 25 mg/minute is not exceeded.
Danish: For at tilpasse behandlingen til større infusionsvolumener, der kan være nødvendige for patienter, som behøver højere doser, bør varigheden af infusionen øges, så den maksimale infusionshastighed på 25 mg/minut ikke overskrides.
English: if you are receiving any treatment for heart disease or liver disease
Danish: - Hvis du er i behandling for hjerte- eller leversygdom
English: Your doctor or nurse will check for side effects during and after your infusion.
Danish: Lægen eller sygeplejersken vil holde øje med bivirkninger under og efter infusionen.
English: The rates of discontinuation were comparable between treatment arms across all age groups.
Danish: Seponeringshyppigheden var sammenlignelig mellem behandlingsarmene på tværs af alle aldersgrupper.
English: Infusion reactions Lartruvo has been associated with infusion reactions (see section 2 “Warnings and precautions”).
Danish: Infusionsreaktioner Lartruvo er forbundet med infusionsreaktioner (se afsnit 2 ”Advarsler og forsigtighedsregler”).
English: Cardiac toxicity
Danish: Kardial toksicitet
English: You must not be given Lartruvo - if you are allergic to olaratumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Lartruvo - hvis du er allergisk over for olaratumab eller et af de øvrige indholdsstoffer i Lartruvo (angivet i afsnit 6).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for olaratumab, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en for olaratumab er CHMP nået frem til følgende videnskabelige konklusioner:
English: There are no or limited amount of data from the use of olaratumab in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af olaratumab til gravide kvinder.
English: Doxorubicin is given on day 1 of each cycle following the Lartruvo infusion.
Danish: Doxorubicin gives på dag 1 i hver serie efter Lartruvoinfusionen.
English: Name and address of the manufacturer(s) responsible for batch release Lilly S.A.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Lilly S.A.
English: During each infusion, your doctor or nurse will check for side effects.
Danish: Under hver infusion vil lægen eller sygeplejersken holde øje med bivirkninger.
English: How you are given Lartruvo 4.
Danish: Sådan bliver du behandlet med Lartruvo 4.
English: No dose reductions other than those recommended for the general patient population are necessary.
Danish: Dosisreduktion ud over de dosisreduktioner, der anbefales til den generelle population, er ikke nødvendig.
English: Summary of survival data - ITT population Lartruvo plus doxorubicin (n = 66)
Danish: Resumé af overlevelsesdata - ITT-population Lartruvo plus doxorubicin (n = 66)
English: Table 1 - Management recommendations for infusion-related reactions (IRRs)
Danish: Tabel 1 - Anbefalinger til håndtering af infusionsrelaterede reaktioner (IRR'er)
English: Patients with gastrointestinal stromal tumours (GIST) or Kaposi sarcoma were not enrolled.
Danish: Patienter med gastrointestinale stromale tumorer (GIST) eller Kaposis sarkom blev ikke indrulleret.
English: Forest plot for subgroup analysis of overall survival (ITT population)
Danish: Forest-plot af subgruppeanalyse af samlet overlevelse (ITT-population)
English: This medicine is given as an infusion into a vein via a drip.
Danish: Dette lægemiddel gives som en infusion i en blodåre via et drop.
English: Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including doxorubicin may result in serious or fatal infections.
Danish: Administration af levende eller levende svækkede vacciner til patienter, der er immunkompromitterede af kemoterapeutika, herunder doxorubicin, kan medføre alvorlige og dødelige infektioner.
English: • Once the reaction has resolved, resume infusion at a 50 %
Danish: • Når reaktionen er gået over, genoptages infusionen med en
English: Demographics and baseline characteristics were quite similar between treatment arms in the phase 2 portion of the clinical trial.
Danish: Demografiske data og baseline-karakteristika var ret sammenlignelige mellem de to behandlingsarme i fase 2-delen af det kliniske studie.
English: Olaratumab may have minor influence on the ability to drive and use machines.
Danish: Olaratumab påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: DO NOT dilute with other solutions or co-infuse with other electrolytes or medicines.
Danish: MÅ IKKE fortyndes med andre opløsninger eller infunderes samtidig med andre elektrolytter eller lægemidler.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC27
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC27
English: In the majority of patients the pain was related to the patients' underlying cancer or metastases or pre-existing or concomitant conditions.
Danish: Hos de fleste patienter var smerten forbundet med patientens underliggende cancer, metastaser, tidligere sygdomme eller samtidige sygdomme.
English: Severe IRRs such as anaphylactic reactions can occur despite the use of premedication.
Danish: Svære IRR'er som anafylaktiske reaktioner kan forekomme til trods af præmedicinering.
English: Your doctor may also give you a smaller dose or delay your dose of Lartruvo if you get serious side effects including a lowering of your white blood cell counts.
Danish: Lægen vil måske også give dig en lavere dosis eller udsætte din dosis af Lartruvo, hvis du får alvorlige bivirkninger, herunder nedsat antal hvide blodlegemer.
English: This leaflet was last revised in < {month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret <{måned ÅÅÅÅ}.>