FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical programme submitted at the time of the original MAA application described 1 clinical study in approximately 500 patients with obstetric and gynaecological infections, of which approximately 250 were treated with meropenem.
Danish: Det kliniske program, som er indsendt på tidspunktet for den originale ansøgning om markedsføringstilladelse, beskrev 1 klinisk undersøgelse med ca. 500 patienter med obstetriske og gynækologiske infektioner, hvoraf ca. 250 blev behandlet med meropenem.
English: For the indication acute bacterial meningitis the CHMP agreed with the MAH proposal concerning the dosage regimen including exclusively higher doses of 2 g to be administered every 8 hours for both adults and adolescents, and children over 50 kg body weight.
Danish: Til indikationen akut bakteriel meningitis vedtog CHMP forslaget fra indehaveren af markedsføringstilladelsen vedrørende dosisregimet inklusive udelukkende højere doser på 2 g til indgivelse hver 8. time til både voksne og unge samt børn med en kropsvægt på over 50 kg. Til børn fra 3 måneder (og derunder) og op til 11 år og børn med en kropsvægt på op til 50 kg blev en dosis på 40 mg/kg indgivet hver 8. time vedtaget.
English: 2719 EE, Zoetermeer, Netherlands
Danish: AstraZeneca BV Louis Pasteurlaan 5 2719 EE, Zoetermeer, Holland
English: Spain
Danish: Spainen
English: The clinical programme submitted at the time of the original MAA application described 1 clinical study in 40 patients, of which 27 were treated with meropenem.
Danish: Det kliniske program, der er indsendt på tidspunktet for den originale ansøgning om markedsføringstilladelse, beskrev 1 klinisk undersøgelse med 40 patienter, hvoraf 27 blev behandlet med meropenem.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection or infusion.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver til injektions-og infusionsvæske, opløsning.
English: • Broncho-pulmonary infections in cystic fibrosis
Danish: • Bronkopulmonale infektioner i forbindelse med cystisk fibrose
English: Broncho-pulmonary infections in cystic fibrosis
Danish: Bronkopulmonære infektioner ved cystisk fibrose
English: The clinical programme submitted at the time of the original MAA application describes 4 clinical studies in approximately 220 patients with meningitis infections, of which approximately 120 were treated with meropenem.
Danish: Det kliniske program, der blev indsendt på tidspunktet for den originale ansøgning om markedsføringstilladelse, beskriver 4 kliniske undersøgelser med ca. 220 patienter med meningitisinfektioner, hvoraf ca. 120 blev behandlet med meropenem.
English: It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving meropenem.
Danish: Det er vigtigt, at du - inden du får meropenem - fortæller din læge, hvis du ammer eller planlægger at amme.
English: The other ingredient is anhydrous sodium carbonate
Danish: Øvrigt indholdsstof: vandfrit natriumcarbonat
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin eller har brugt det for nylig.
English: Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
Danish: Hvert hætteglas indeholder meropenemtrihydrat svarende til 1 g vandfri meropenem.
English: The clinical programme submitted at the time of the original MAA application described 6 clinical studies in approximately 950 patients with SSSIs, of which approximately 470 were treated with meropenem.
Danish: Det kliniske program, som blev indsendt på tidspunktet for den originale ansøgning om markedsføringstilladelse, beskrev 6 kliniske undersøgelser med ca. 950 patienter med SSSI, hvoraf ca. 470 blev behandlet med meropenem.
English: Remove the needle and syringe from the vial and throw the empty vial away in a safe place.
Danish: Træk nål og sprøjte ud af hætteglasset og kasser det tomme hætteglas på behørig vis.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Hvis der er tvivl om anvendeligheden af præparatet på grund af den lokale resistensprævalens for nogle infektioner, bør der søges professionel rådgivning.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for destruktion og anden håndtering Injektion
English: LIST OF EXCIPIENTS Anhydrous sodium carbonate.
Danish: LISTE OVER HJÆLPESTOFFER Natriumcarbonat, vandfri.
English: Ireland: Meronem IV
Danish: Meronem IV
English: Close the cap of your cannula and carefully throw the syringe away in your sharps bin.
Danish: Luk hætten på din kanyle og smid på sikker måde kanylen i din kanylespand.
English: The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response.
Danish: Infektionstypen, dens sværhedsgrad og det kliniske respons skal tages i betragtning, når meropenemdosis og behandlingsvarighed fastsættes.
English: Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
Danish: Hvert hætteglas indeholder meropenemtrihydrat svarende til 500 mg vandfri meropenem.
English: The CHMP agreed with the statement proposed by the MAH.
Danish: CHMP vedtog den formulering, der var foreslået af indehaveren af markedsføringstilladelsen.
English: The clinical programme submitted at the time of the original MAA application described 6 clinical studies in approximately 1200 patients, of which approximately 650 were treated with meropenem.
Danish: Det kliniske program, som er indsendt på tidspunktet for den originale ansøgning om markedsføringstilladelse, beskrev 6 kliniske undersøgelser med ca. 1200 patienter, hvoraf ca. 650 blev behandlet med meropenem.
English: The clinical programme submitted at the time of the original MAA application described 2 clinical studies in approximately 470 patients, of which approximately 230 were treated with meropenem.
Danish: Det kliniske program, som er indsendt på tidspunktet for den originale ansøgning om markedsføringstilladelse, beskrev 2 kliniske undersøgelser med ca. 470 patienter, hvoraf ca. 230 blev behandlet med meropenem.
English: There was increased evidence of abortions at 500 mg/kg in a preliminary study in monkeys.
Danish: I et præliminært forsøg med aber var der stigende tegn på aborter ved doser på 500 mg/kg.
English: Not known angioedema, anaphylaxis (see sections 4.3 and 4.4)
Danish: Ikke kendt angioødem, anafylaksi (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder meropenemtrihydrat svarende til 500 mg vandfri meropenem.
English: Complicated skin and soft tissue infections
Danish: Komplicerede infektioner i hud og blødt væv
English: MERREM 250 mg Powder and solvent for solution for infusion
Danish: MERREM 250 mg polvere e solvente per soluzione per infusione
English: Meronem and associated names (see Annex I) 500 mg powder for solution for injection or infusion Meronem and associated names (see Annex I) 1 g powder for solution for injection or infusion
Danish: Meronem og tilsvarende navne (se bilag I) 500 mg pulver til injektions-og infusionsvæske, opløsning.
English: Meronem I.V., 500 500 mg Powder for solution for injection or infusion
Danish: Meronem I.V., 500 500 mg Pulver til injektions-og infusionsvæske, opløsning
English: • Complicated skin and soft tissue infections
Danish: • Komplicerede hud- og bløddelsinfektioner
English: Pneumonia, including community acquired pneumonia and nosocomial pneumonia
Danish: Pneumoni, inklusive samfundserhvervet pneumoni og nosokomiel pneumoni
English: HOW TO USE MERONEM
Danish: SÅDAN SKAL DU TAGE MERONEM
English: Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see section 4.4).
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: Consequently taking into account the bacteria involved in this situation, the current microbiological context, the clinical practice, the medical need of penems in some cases, and the fact that meropenem is intended only in severe bacterial infections suspected or due to pathogens resistant to other beta-lactams and susceptible to meropenem, the CHMP considered that the indication for the treatment of febrile neutropenia could be accepted.
Danish: I betragtning af de bakterier, der er involveret i situationen, den nuværende mikrobiologiske kontekst, den kliniske praksis, det medicinske behov for penemer i nogle tilfælde og det faktum, at meropenem kun er beregnet til svære bakterieinfektioner, der mistænkes for eller skyldes patogener, som er resistente over for andre beta-lactamer og modtagelige over for meropenem, vurderede CHMP som følge deraf, at indikationen til behandling af febril neutropeni kunne accepteres.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Meropenem trihydrate equivalent to 500 mg anhydrous meropenem Meropenem trihydrate equivalent to 1 g anhydrous meropenem
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Meropenemtrihydrat svarende til 500 mg vandfri meropenem.
English: If you use more Meronem than you should
Danish: Hvis du har taget for meget Meronem
English: Section 6.1 - List of excipients
Danish: Afsnit 6.1 - Hjælpestoffer
English: Table 1 System Organ Class
Danish: Tabel 1
English: MERREM 500 mg Powder and solvent for solution for infusion
Danish: MERREM 500 mg polvere e solvente per soluzione per infusione
English: • Pneumonia, including community acquired pneumonia and nosocomial pneumonia.
Danish: • Pneumoni, inklusive pneumoni erhvervet uden for sygehus og nosokomiel pneumoni.
English: - If you have any further questions, ask your doctor or nurse.
Danish: Spørg lægen eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: What Meronem looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: 500 mg 500 mg Powder for solution for injection or infusion
Danish: 500 mg 500 mg Pulver til injektions-og infusionsvæske, opløsning
English: BEFORE YOU USE MERONEM
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE MERONEM
English: If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meronem.
Danish: Spørg lægen eller sundhedspersonalet, inden du tager Meronem, hvis du er i tvivl, om nogle af ovenstående punkter gælder for dig.
English: $Species that show natural intermediate susceptibility £All methicillin-resistant staphylococci are resistant to meropenem †Resistance rate ≥ 50% in one or more EU countries.
Danish: † Resistensrate ≥ 50% i et eller flere EU-lande.
English: Remove the needle from the syringe and throw the needle away carefully in your sharps bin.
Danish: Indgivelse af Meronem gennem en kort kanyle eller venflon Fjern nålen fra sprøjten og smid på en sikker måde nålen i din kanylespand.
English: Injection
Danish: Indgivelse af injektionen
English: Uncommon
Danish: Ikke almindelige
English: Consequently taking into account the microbiological activity of meropenem, the current microbiological context, the clinical practice, the medical need of penems in some situations, and the fact that meropenem is intended only in severe bacterial infections suspected or due to pathogens resistant to other beta-lactams and susceptible to meropenem, the CHMP considered the indication “acute bacterial meningitis” to be acceptable.
Danish: I betragtning af meropenems mikrobiologiske aktivitet, den nuværende mikrobiologiske kontekst, den kliniske praksis, det medicinske behov for penemer i visse situationer og det faktum, at meropenem kun bør bruges til svære bakterieinfektioner, der mistænkes for eller skyldes patogener, som er resistente over for andre beta-lactamer og modtagelige over for meropenem, vurderede CHMP som følge heraf, at indikationen ”akut bakteriel meningitis” var acceptabel:
English: Meronem IV 500mg 500 mg Powder for solution for injection or infusion
Danish: Meronem IV 500mg 500 mg Pulver til injektions-og infusionsvæske, opløsning
English: Estonia: Meronem
Danish: Dosis Meronem
English: Meronem IV 500mg 500mg Powder for solution for injection or infusion
Danish: Meronem IV 500mg 500mg Pulver til injektions-og infusionsvæske, opløsning
English: Management of febrile neutropenic patients
Danish: Patienter med neutropeni og feber
English: PHARMACEUTICAL FORM Powder for solution for injection or infusion.
Danish: LÆGEMIDDELFORM Pulver til injektions-og infusionsvæske, opløsning.
English: AstraZeneca UK Ltd.
Danish: AstraZeneca S.p.A.
English: Consequently, taking into account the microbiological activity of -penems, the current microbiological context, the clinical practice, the medical need of penems in some situations, and the fact that meropenem is intended only in severe bacterial infections suspected or due to pathogens resistant to other beta-lactams and susceptible to meropenem, the CHMP considered the following indication to be acceptable:
Danish: I betragtning af den mikrobiologiske aktivitet af penemer, den nuværende mikrobiologiske kontekst, den kliniske praksis, det medicinske behov for penemer i visse situationer og det faktum, at meropenem kun bør bruges til svære bakterieinfektioner, der mistænkes for eller skyldes patogener, der er resistente over for andre beta-lactamer og modtagelige over for meropenem, vurderede CHMP som følge heraf, at følgende indikation var acceptabel:
English: Consequently, taking into account the knowledge of the pharmacological class of -penems, the current microbiological context, the clinical practice and the clinical recommendations, the medical need of penems in some situations, and considering that meropenem should be used only in severe bacterial infections suspected or due to pathogens resistant to other beta-lactams and susceptible to meropenem, the CHMP considered that the following meropenem wording of the SPC therapeutic indication was acceptable:
Danish: I betragtning af den viden, der er til rådighed om den farmakologiske gruppe af penemer, den nuværende mikrobiologiske kontekst, den kliniske praksis og de kliniske anbefalinger, det medicinske behov for penemer i visse situationer og i betragtning af, at meropenem kun bør bruges til svære bakterieinfektioner, der mistænkes for eller skyldes patogener, der er resistente over for andre betalactamer og er modtagelige over for meropenem, vurderede CHMP som følge heraf, at følgende ordlyd vedrørende meropenem i produktresuméet var acceptabel:
English: 250 mg Powder for solution for injection or infusion
Danish: 250 mg Pulver til injektions-og infusionsvæske, opløsning
English: • Skin rash, itchy skin.
Danish: • Hududslæt, kløende hud.
English: Powder for solution for injection or infusion
Danish: Pulver til injektions-og infusionsvæske, opløsning
English: Meronem 500 mg 500 mg Powder for solution for injection or infusion
Danish: Meronem 500 mg 500 mg Pulver til injektions-og infusionsvæske, opløsning
English: Meronem 500mg 500 mg Powder for solution for injection or infusion
Danish: Meronem 500mg 500 mg Pulver til injektions-og infusionsvæske, opløsning
English: Meronem 500mg 500mg Powder for solution for injection or infusion
Danish: Meronem 500mg 500mg Pulver til injektions-og infusionsvæske, opløsning
English: 500mg Powder for solution infusion
Danish: 500mg Pulver til infusionsvæske, opløsning
English: 500 mg Powder for solution for injection or infusion
Danish: 500 mg Pulver til injektions-og infusionsvæske, opløsning
English: Haemodialysis will remove meropenem and its metabolite.
Danish: Meropenem og dens metabolit udskilles ved hæmodialyse.
English: 500mg Powder for solution for injection
Danish: 500mg Pulver til injektionsvæske, opløsning
English: 500mg Powder for solution for injection or infusion
Danish: 500mg Pulver til injektions-og infusionsvæske, opløsning
English: It is given according to official recommendations.
Danish: Den gives i overensstemmelse med de officielle anbefalinger.
English: People who did not respond to the first dose can be given a second dose after at least four weeks.
Danish: Personer, som ikke reagerer på den første dosis, kan gives endnu en dosis efter mindst fire uger.
English: This will help to protect against diseases caused by these viruses.
Danish: Dette er med til at beskytte mod sygdomme, som kan forårsages af disse virusser.
English: They should be re-vaccinated at between 12 and 15 months.
Danish: De bør vaccineres igen i 12-15månedersalderen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for M-M-RVaxPro on 5 May 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for M-M-RVaxPro den 5. maj 2006.
English: It must also not be given to patients with certain blood or immune diseases.
Danish: Vaccinen må heller ikke gives til patienter med visse blod- eller immunsygdomme.
English: It is given as one dose injected into a muscle or under the skin, preferably in the thighs of younger children and the shoulder in older children and adults.
Danish: Det gives som én dosis ved injektion i en muskel eller under huden, helst i låret hos små børn og i skulderen hos større børn og voksne.
English: The full EPAR for M-M-RVaxPro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for M-M-RVaxPro findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these viruses.
Danish: Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, hvis det udsættes for nogle af disse virusser.
English: They may also be given an additional vaccination against measles.
Danish: De kan eventuelt også gives en yderligere vaccination mod mæslinger.
English: Under some special circumstances, it can also be used in babies as young as nine months.
Danish: Under visse særlige omstændigheder kan det også anvendes til spædbørn på helt ned til ni måneder.
English: This is a summary of the European public assessment report (EPAR) for M-M-RVaxPro.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for M-MRVaxPro.
English: Babies between nine and 12 months can be given the vaccine if they are considered to be at special risk, for example, if there is an outbreak in a day-care centre or the baby is travelling to an area where measles is common.
Danish: Spædbørn i alderen 9 til 12 måneder kan modtage vaccinen, hvis det vurderes, at de er udsat for en særlig risiko, f.eks. i forbindelse med sygdomsudbrud i en vuggestue, eller hvis spædbarnet medbringes til et område, hvor mæslinger er udbredt.
English: M-M-RVaxPro is a vaccine.
Danish: M-M-RVaxPro er en vaccine.
English: Injection site reactions were less common when the vaccine was injected into a muscle.
Danish: Reaktioner på injektionsstedet er mindre hyppige, når vaccinen gives ved injektion i en muskel.
English: When a person is given the vaccine, the immune system recognises the weakened viruses as ‘foreign' and makes antibodies against them.
Danish: Når vaccinen gives, opfatter immunsystemet de svækkede virus som "fremmede" og producerer antistoffer mod dem.
English: For people with thrombocytopenia (low blood platelet counts) or any problems with blood clotting, the vaccine should only be injected under the skin to avoid bleeding.
Danish: Hos personer med trombocytopeni (for lavt antal blodplader) eller andre blodkoaguleringsproblemer bør vaccinen udelukkende injiceres under huden for at undgå blødninger.
English: The CHMP decided that M-M-RVaxPro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved M-M-RVaxPro opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: However, the immune response for measles was lower in babies who started vaccination at nine months.
Danish: Immunresponsen over for mæslinger var dog lavere hos spædbørn, som påbegyndte vaccinationsforløbet i en alder af ni måneder.
English: M-M-RVaxPro must not be given during pregnancy, any illness with fever (over 38.5°C) or active untreated tuberculosis (TB).
Danish: M-M-RVaxPro må ikke gives under graviditet, ved sygdom med feber (over 38,5 °C) eller ved aktiv, ubehandlet tuberkulose (TB).
English: In a study of 1,279 children, M-M-RVaxPro triggered the same level of immune response as a comparator vaccine, with more than 98% of vaccinated patients having sufficient levels of antibodies against the three viruses.
Danish: I en undersøgelse med 1 279 børn gav M-M-RVaxPro den samme immunrespons som sammenligningsvaccinen, idet over 98 % af de vaccinerede patienter havde tilstrækkelige antistoffer mod de tre vira.
English: The company that makes M-M-RVaxPro will continue to monitor the side effects to see if using recombinant albumin in the manufacturing process of M-M-RVaxPro leads to side effects such as allergic reactions.
Danish: Virksomheden, der fremstiller M-M-RVaxPro, skal fortsætte overvågningen af bivirkninger for at fastslå, om brugen af rekombinant albumin i fremstillingsprocessen for M-M-RVaxPro medfører bivirkninger som f.eks. allergiske reaktioner.
English: The most common side effects with M-M-RVaxPro (seen in more than 1 patient in 10) are fever (38.5°C or higher), and injection site redness, pain and swelling.
Danish: De hyppigste bivirkninger ved M-M-RVaxPro (som ses hos flere end 1 ud af 10 patienter) er feber (38,5 °C eller derover) samt rødme, smerte og hævelse på injektionsstedet.
English: This study showed that, after the second dose, the production of antibodies against mumps and rubella in babies who started vaccination as young as nine months was similar to those of babies who started vaccination at 12 months.
Danish: Denne undersøgelse viste, at efter den anden dosis var produktionen af antistoffer mod fåresyge og røde hunde hos spædbørn, som allerede påbegyndte vaccinationsforløbet i en alder af ni måneder, den samme som hos de spædbørn, som først påbegyndte vaccinationsforløbet i en alder af 12 måneder.
English: A second study in 1,997 children looking specifically at mumps showed that M-M-RVaxPro led to sufficient amounts of antibodies against mumps, while a third study in 776 children showed that immune responses triggered by M-M-RVaxPro were the same regardless of whether it was injected into a muscle or under the skin.
Danish: En anden undersøgelse hos 1 997 børn, der specifikt så nærmere på fåresyge, viste, at M-M-RVaxPro gav tilstrækkelige antistoffer mod fåresyge, mens en tredje undersøgelse hos 776 børn viste, at den immunrespons, som M-M-RVaxPro fremkaldte, var den samme, uanset om den blev injiceret i en muskel eller under huden.
English: What measures are being taken to ensure the safe and effective use of M-M-RVaxPro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af M-M-RVaxPro?
English: M-M-RVaxPro should not be used in people who may be hypersensitive (allergic) to any measles, mumps or rubella vaccine, or to any of the ingredients, including neomycin (an antibiotic).
Danish: M-M-RVaxPro må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for nogen vaccine mod mæslinger, fåresyge eller røde hunde, eller over for nogen af indholdsstofferne, herunder neomycin (et antibiotikum).
English: Other information about M-M-RVaxPro
Danish: Andre oplysninger om M-M-RVaxPro
English: For more information about treatment with M-M-Rvaxpro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med M-M-RVaxPro, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is M-M-RVaxPro and what is it used for?
Danish: Hvad er M-M-RVaxPro, og hvad anvendes det til?