FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of a single administration of metamizole, breastmilk should be discarded for a 48-hour period before breastfeeding can be resumed.
Danish: I tilfælde af en enkelt administration af metamizol bør modermælk bortskaffes i 48 timer bagefter, før amning kan genoptages.
English: This single dose can be taken up to 4 times daily at intervals of 6-8 hours.
Danish: Enkeltdosen kan tages op til 4 gange dagligt med 6-8 timers mellemrum.
English: No data was available to support a change in posology recommendations for the suppository formulations dosed at 100 mg and 200 mg, as well as for the combination products.
Danish: Der var ingen tilgængelige oplysninger, der understøttede en ændring i doseringsanbefalingerne for stikpille-formuleringen på 100 mg og 200 mg samt kombinationsprodukterne.
English: Some data suggest that metamizole and its main metabolite 4-methyl-amino-antipyrine (MAA) may have a combined central and peripheral mechanism of action.
Danish: Visse oplysninger tyder på, at metamizol og dets hovedmetabolit, 4-methyl-amino-antipyrin (MAA), kan have en central og perifer virkningsmekanisme.
English: The active substance is contraindicated in pregnancy and breastfeeding in some Member States, while in others it is contraindicated only in the third trimester of pregnancy and breastfeeding; furthermore, in some Member States it is contraindicated in the first and third trimester of pregnancy and breastfeeding.
Danish: Det aktive stof er kontraindiceret ved graviditet og amning i nogle medlemsstater, mens det i andre kun er kontraindiceret i tredje trimester af en graviditet; derudover er det i nogle medlemsstater kontraindiceret i første og tredje trimester af en graviditet og ved amning.
English: In view of the known risks associated with the use of metamizole, the differences between the product information of metamizole-containing medicines across the EU Member States raise concern.
Danish: I lyset af de kendte risici ved brug af metamizol giver forskellene i produktinformationen for metamizolholdige lægemidler mellem EU-medlemsstaterne grund til bekymring.
English: The CHMP further noted that two recent studies showed that single intravenous doses of metamizole used for prevention or treatment of postoperative pain were safe in more than 400 infants younger than 1 year (Fieler M et al. 20151, Sümpelmann R et al. 20172).
Danish: CHMP bemærkede desuden, at to nylige studier viste, at intravenøse enkeltdoser af metamizol til forebyggelse eller behandling af postoperative smerter var sikre hos flere end 400 spædbørn under 1 år (Fieler M et al. 20151, Sümpelmann R et al. 20172).
English: On 26 April 2018, Poland therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess all data available concerning the maximum daily dose and its contraindications on pregnancy and breastfeeding, and issue an opinion as to whether the relevant marketing authorisations should be varied.
Danish: Polen startede derfor den 26. april 2018 en indbringelsessag i henhold til artikel 31 i direktiv 2001/83/EF og anmodede CHMP om at undersøge alle tilgængelige oplysninger vedrørende den maksimale daglige dosis og kontraindikationerne for graviditet og amning og afgive en udtalelse om, hvorvidt de pågældende markedsføringstilladelser bør ændres.
English: An inhibition of prostaglandin (PG) synthesis is known, based on interaction with different cyclooxygenases (COX), resulting in changes in the arachidonic acid metabolism.
Danish: Hæmningen af prostaglandin (PG)-syntesen er kendt, baseret på interaktion med forskellige cyclooxygenaser (COX), hvilket medfører ændringer i arachidonsyre-metabolismen.
English: In addition, a general rejection of the use of metamizole for administration in infants below the age of 3 months is not considered to be justified based on the fact that no particular concerns arose from the studies which included patients in this age group.
Danish: Derudover vurderes en generel afvisning af brugen af metamizol hos spædbørn under 3 måneder ikke at være berettiget, eftersom der ikke var nogen særlige betænkeligheder i de studier, hvor der indgik patienter i denne aldersgruppe.
English: Metamizole has been associated with agranulocytosis and anaphylactic shock.
Danish: Metamizol er blevet forbundet med agranulocytose og anafylaktisk chok.
English: Current indications for metamizole (as single ingredient) include acute severe pain after trauma or surgery, painful colic, tumour pain, other acute or chronic pain, if other therapeutic measures are contraindicated, and high fever, not responding to other measures.
Danish: De aktuelle indikationer for metamizol (som enkeltstof) omfatter akutte svære smerter efter traume eller kirurgi, smertefuld kolik, kræftsmerter, andre akutte eller kroniske smerter, hvis andre terapeutiske foranstaltninger er kontraindiceret, og høj feber, der ikke reagerer på andre midler.
English: In children and adolescents up to 14 years old, a dose of 8-16 mg metamizole per kg body weight as a single dose is recommended.
Danish: Hos børn og unge op til 14 år anbefales en dosis på 8-16 mg metamizol pr. kg legemsvægt som enkeltdosis.
English: With regards to pregnancy and lactation, although data is limited there is no evidence of teratogenic or embryotoxic effects of metamizole when used during the 1st trimester.
Danish: Med hensyn til graviditet og amning er data begrænsede, men der er ikke evidens for teratogene eller embryotoksiske virkninger ved metamizol ved brug i løbet af første trimester.
English: Besides peripheral inhibition of PG synthesis, central activities have been supposed and documented.
Danish: Ud over perifer hæmning af PG-syntesen har der været formodninger om centrale virkninger, som senere er blevet dokumenteret.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for metamizole-containing medicinal products.
Danish: Udvalget anbefaler som følge heraf ændring af betingelserne for markedsføringstilladelse for metamizolholdige lægemidler.
English: In view of the above, the Committee considers that the benefit-risk balance of metamizole-containing medicinal products remains unchanged subject to the agreed amendments to the product information.
Danish: I lyset af ovenstående mener komitéen, at benefit/risk-forholdet for metamizolholdige lægemidler er uændret under forudsætning af, at de aftalte ændringer indføres i produktinformationen.
English: As a result of this investigation, it was observed that the maximum daily dose of metamizole reflected in the Product Information of the different medicinal products varies from 1,5 g to 6 g. With regards to contraindication in pregnancy and breastfeeding, discrepancies were also noted.
Danish: Som følge af denne undersøgelse blev det konstateret, at den maksimale daglige dosis metamizol, der er afspejlet i produktinformationen for de forskellige lægemidler, varierer fra 1,5 g til 6 g. Der blev også fundet forskelle med hensyn til kontraindikationen for graviditet og amning.
English: The Committee also noted that the metabolites of metamizole pass into breastmilk in considerable amounts, and therefore recommended that repeated use of metamizole during breastfeeding should be avoided.
Danish: Udvalget bemærkede også, at metamizols metabolitter passerer over i modermælk i betydelige mængder, og anbefalede derfor, at gentagen brug af metamizol under amning bør undgås.
English: The active substance metamizole (also referred to as dipyrone) is a non-addictive pyrazole-type analgesic, spasmolytic and antipyretic drug with weak anti-inflammatory effects.
Danish: Det aktive stof metamizol (også kendt som dipyron) er et ikkeadditivt analgetisk, spasmolytisk og antipyretisk lægemiddel af pyrazol-typen med svag antiinflammatorisk virkning.
English: • The Committee concluded that the posology recommendations for metamizole-containing medicinal products should be harmonised.
Danish: • Udvalget konkluderede, at doseringsanbefalingerne for metamizolholdige lægemidler bør harmoniseres.
English: Poland considered that it is in the interests of the Union to harmonise the information regarding maximum daily dose and contraindications in pregnancy and breastfeeding in the product information of all metamizole-containing medicinal products in the EU.
Danish: Polen anså det for at være i EU's interesse at harmonisere oplysningerne vedrørende den maksimale daglige dosis og kontraindikationerne for graviditet og amning i produktinformationen for alle metamizolholdige lægemidler i EU.
English: However, there is evidence of fetotoxicity in terms of fetal renal impairment and ductus arteriosus constriction when used in the third trimester and so the Committee considered metamizole should be contraindicated during the third trimester.
Danish: Der er dog evidens for fostertoksicitet i form af nedsat nyrefunktion og konstriktion af ductus arteriosus ved brug af stoffet i tredje trimester, og derfor vurderede udvalget, at metamizol bør være kontraindiceret i tredje trimester.
English: The Committee also considered that metamizole containing medicinal products should be contraindicated in the third trimester of pregnancy due to the risks of fetal renal impairment and ductus arteriosus constriction.
Danish: Udvalget fandt også, at metamizolholdige lægemidler bør kontraindiceres i tredje trimester af en graviditet som følge af risiciene for nedsat nyrefunktion og konstriktion af ductus arteriosus hos fosteret.
English: In the frame of a Non Urgent Information (NUI) request, the maximum daily dose and contraindications in pregnancy and breastfeeding were investigated for all metamizole-containing products authorised in European Union (EU).
Danish: I forbindelse med en ikkevigtig meddelelsesprocedure (Non Urgent Information) blev den maksimale daglige dosis og kontraindikationer for graviditet og amning undersøgt for alle metamizol-holdige lægemidler, der er godkendt i EU.
English: Metamizole is available as tablets (film tablet or dispersible), oral drops, solution for injection, and suppositories.
Danish: Metamizol fås som tabletter (filmovertrukne eller opløselige), orale dråber, injektionsvæske (opløsning) og suppositorier (stikpiller).
English: Age appropriate formulations (oral drops, solution for injection) are available.
Danish: Der findes aldersrelevante formuleringer (orale dråber, injektionsvæske, opløsning).
English: The recommended oral single dose in adults and adolescents aged 15 years or over is also 500 to 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Danish: Den anbefalede orale enkeltdosis hos voksne og unge i alderen 15 år eller derover er også 5001.000 mg. En enkeltdosis kan tages op til 4 gange dagligt med 6-8 timers mellemrum, dvs. en maksimal daglig dosis på 4.000 mg.
English: • The Committee reviewed the totality of the data submitted in relation to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
Danish: • Udvalget gennemgik alle fremlagte oplysninger i forhold til den maksimale daglige dosis og brugen af metamizol under graviditet og amning.
English: • The Committee considered the identified divergences in the product information of metamizole containing medicinal products, relating to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
Danish: • Udvalget vurderede de identificerede forskelle i produktinformationen for metamizolholdige lægemidler i forhold til den maksimale daglige dosis og brugen af metamizol under graviditet og amning.
English: Based on the data assessed, the Committee recommended a parenteral single dose in adults and adolescents aged 15 years or over of 500 - 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Danish: På grundlag af de undersøgte oplysninger anbefalede udvalget en parenteral enkeltdosis hos voksne og unge i alderen 15 år eller derover på 500-1.000 mg. En enkeltdosis kan tages op til 4 gange dagligt med 6-8 timers mellemrum, dvs. en maksimal daglig dosis på 4.000 mg. Om nødvendigt er det dog i orden at tillade en parenteral enkeltdosis på 2.500 mg metamizol og en maksimal daglig dosis på 5.000 mg metamizol.
English: Article 31 of Directive 2001/83/EC for metamizole-containing medicinal products
Danish: • Udvalget for Lægemidler til Mennesker (CHMP) gennemførte proceduren vedrørende metamizolholdige lægemidler i henhold til artikel 31 i direktiv 2001/83/EF.
English: This is ok.
Danish: Dette er i orden.
English: Cumulative intermediate analyses - annually.
Danish: Kumulative intermediære analyser - årligt.
English: Treatment Difference a
Danish: Behandlingsforskel a
English: Your doctor will explain more.
Danish: Din læge vil give en yderligere forklaring.
English: Try not to breathe through your nose.
Danish: Forsøg ikke at trække vejret gennem næsen.
English: Treatment will restart.
Danish: Behandlingen vil starte igen.
English: In this situation, you should inform your doctor as soon as possible.
Danish: I denne situation skal du informere lægen snarest muligt.
English: It may be necessary to confirm positive opiate screens by more specific methods.
Danish: Det kan være nødvendigt at bekræfte positive opiatscreeninger ved hjælp af mere specifikke metoder.
English: c Tested using alpha of 0.05.
Danish: c Testet ved anvendelse af alfa på 0,05.
English: The patient should be observed and appropriate hydration maintained.
Danish: Patienten skal observeres og passende hydrering opretholdes.
English: These findings were more marked in young animals.
Danish: Disse fund var mest markante hos unge dyr.
English: Their frequency cannot be estimated from available data.
Danish: Deres hyppighed kan ikke estimeres ud fra forhåndenværende data.
English: The ampoule is labelled in English only.
Danish: Ampullen er kun mærket på engelsk.
English: - Depression or mental health problems.
Danish: - Depression eller psykiske problemer.
English: Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italy
Danish: Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italien
English: Other side effects can include:
Danish: Andre bivirkninger kan omfatte:
English: Secondary endpoints:
Danish: Sekundære endepunkter:
English: Stevens-Johnson syndrome,
Danish: Steven-Johnsons syndrom,
English: Cmax (μg/ml) AUC(0-24) (µg•h/ml)
Danish: Cmax (μg/ml) AUC(0-24) (µg•t/ml)
English: - A severe allergic reaction.
Danish: - En kraftig allergisk reaktion.
English: Symptoms are listed in section 4.
Danish: Symptomer er angivet i afsnit 4.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/973/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/973/001
English: Your doctor may need to give you regular blood tests to check how well your blood can clot.
Danish: Lægen skal måske foretage regelmæssige blodtests for at kontrollere, hvor godt dit blod størkner.
English: You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.
Danish: Du og din læge vil beslutte, om du skal fortsætte behandlingen, hvor brug af et antibiotikum fra en anden klasse også overvejes.
English: e P-value determined using a log-rank test.
Danish: e P-værdi bestemt ved anvendelse af en log-rank-test.
English: PK/PD relationship
Danish: PK/PD-forhold
English: - False test results
Danish: - Forkerte testresultater
English: If this happens to you, do not drive or use any tools or machines.
Danish: Hvis det sker for dig, må du ikke køre i trafikken eller anvende værktøj eller maskiner.
English: You will hear one ‘beep' and the status light will turn green.
Danish: Du hører et ”bip”, og statuslyset bliver grønt.
English: Quinsair should not be given to children and adolescents less than 18 years old as there is not enough information about its use in this age group.
Danish: Quinsair bør ikke anvendes til børn og unge under 18 år, da der ikke er nok oplysninger om anvendelsen heraf til denne aldersgruppe.
English: Elderly patients and women may be more sensitive to QTc-prolonging medicinal products.
Danish: Ældre patienter og kvinder kan være mere følsomme over for QTc-forlængende lægemidler.
English: Women who take these types of medicines may be more likely to be affected.
Danish: Kvinder, der tager disse typer medicin, har muligvis en større risiko for at blive påvirket.
English: 1) When you start your treatment, sit in a relaxed, upright position.
Danish: 1) Når du starter på din behandling, skal du sidde i en afslappet, oprejst stilling.
English: - Resistance to antibiotics
Danish: - Resistens over for antibiotika
English: Approximately 30 to 40% of levofloxacin is bound to serum protein.
Danish: Ca. 30 til 40% af levofloxacin bindes til serumprotein.
English: FEV1 percent predicted
Danish: Forventet FEV1-procent
English: You then start another treatment course.
Danish: Herefter starter du på et nyt behandlingsforløb.
English: Quinsair may make your skin become more sensitive to sunlight.
Danish: Quinsair kan gøre din hud mere følsom over for sollys.
English: If the infection is not properly treated it will continue to damage the lungs, causing further problems with breathing.
Danish: Hvis infektionen ikke behandles korrekt, vil den fortsætte med at beskadige lungerne, hvilket medfører yderligere problemer med vejrtrækningen.
English: Important information to know before you start - Each ampoule is for single use only.
Danish: Vigtige oplysninger, du skal kende, før du starter - Hver ampul er udelukkende til engangsbrug.
English: It takes about 5 minutes to inhale the medicine using the nebuliser.
Danish: Det tager ca. 5 minutter at inhalere lægemidlet ved anvendelse af nebulisatoren.
English: Patients who experience such symptoms should be advised not to drive or use machines.
Danish: Patienter, der oplever sådanne symptomer, skal rådes til ikke at føre motorkøretøj eller betjene maskiner.
English: Interference with laboratory tests
Danish: Interferens med laboratorietests
English: In the event of overdose, symptomatic treatment should be implemented.
Danish: I tilfælde af overdosering skal der iværksættes symptomatisk behandling.
English: What if I need to stop my treatment before I've finished?
Danish: Hvis du bliver nødt til at standse din behandling, før du er færdig?
English: This medicine does not require any special temperature storage conditions.
Danish: Dette lægemiddel kræver ingen særlige temperaturopbevaringsbetingelser.
English: Study 204 (ITT) a
Danish: Studie 204 (ITT) a
English: Other relevant information
Danish: Andre relevante oplysninger
English: Results obtained for the primary and key secondary endpoints are provided in Table 2.
Danish: De opnåede resultater for det primære endepunkt og de sekundære nøgleendepunkter er vist i tabel 2.
English: Elimination is primarily by the renal route (> 85% of the dose following oral or intravenous administration).
Danish: Elimination sker primært via nyrerne (> 85% af dosen efter oral eller intravenøs administration).
English: In the “crimped area” on either side of the ampoule tail LOT
Danish: I det “kreppede område” på begge sider af ampulunderdelen LOT
English: Interactions with CYP inhibitors or inducers are thus not expected.
Danish: Interaktion med CYP-hæmmere eller induktorer forventes derfor ikke.
English: ** See paragraph below for further details.
Danish: ** Se afsnit nedenfor for yderligere oplysninger.
English: Sit the patient in a relaxed, upright position.
Danish: Anbring patienten i en afslappet, oprejst stilling.
English: Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids.
Danish: Din risiko er øget, hvis du er ældre (over 60 år), har gennemgået en organtransplantation, har nyreproblemer, eller hvis du bliver behandlet med kortikosteroider.
English: This is because both active substances are capable of blocking the renal tubular secretion of levofloxacin.
Danish: Dette skyldes, at begge aktive stoffer er i stand til at blokere den renale tubulære sekretion af levofloxacin.
English: - Check that your Zirela Nebuliser System works properly before starting your treatment.
Danish: - Kontrollér, at dit Zirela-nebulisatorsystem fungerer korrekt, før du starter din behandling.
English: The apparent total body clearance and apparent volume of distribution were not affected by the race of the subjects.
Danish: Den tilsyneladende, totale kropsclearance og det tilsyneladende fordelingsvolumen var ikke påvirket af personernes race.
English: However if it is nearly the time for your next dose, skip the missed dose.
Danish: Hvis det næsten er tidspunktet for din næste dosis, skal du dog springe den glemte dosis over.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/03/2015
Danish: Dato for første markedsføringstilladelse: 26/03/2015
English: 6.6 Special precautions for disposal and other handling For single use only.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Udelukkende til engangsbrug.
English: Inhale this medicine at least 15 minutes or up to 4 hours before your next dose of Quinsair.
Danish: Inhalér dette lægemiddel mindst 15 minutter eller op til 4 timer før din næste dosis af Quinsair.
English: ECG monitoring should be undertaken because of the possibility of QT interval prolongation.
Danish: Der bør foretages EKG-overvågning på grund af risikoen for QTintervalforlængelse.
English: Respiratory domain of Cystic Fibrosis Questionnaire - Revised (CFQ-R)
Danish: Respiratorionsafsnit i cystisk fibrose-spørgeskema - revideret (CFQ-R)
English: You may develop diarrhoea during or after your treatment with Quinsair.
Danish: Du kan udvikle diarré under eller efter din behandling med Quinsair.
English: Quinsair may make you feel dizzy, tired or weak, or cause problems with your eyesight.
Danish: Quinsair kan gøre, at du føler dig svimmel, træt eller svag, eller give problemer med synet.
English: 6) When all of the medicine has been delivered, you will hear two ‘beeps', which means the treatment is complete.
Danish: 6) Når al medicinen er inhaleret, vil du høre to “bip”, som betyder, at behandlingen er færdig.
English: This should be connected to either an eBase Controller or an eFlow rapid Control Unit.
Danish: Dette skal forbindes til enten en eBase-styreenhed eller en eFlow rapidstyreenhed.
English: Do not take any medicines to treat your diarrhoea without first checking with your doctor.
Danish: Lad være med at tage medicin til at behandle din diarré uden først at tale med lægen.
English: If you are diabetic, you should monitor your blood glucose levels carefully.
Danish: Hvis du er diabetiker, skal du holde omhyggeligt øje med dine blodsukkerniveauer.
English: How long do I use it for?
Danish: Så længe skal du bruge det?
English: Pivotal Study - Study 209 (Core Phase; ITT)
Danish: Hovedstudie - studie 209 (kernefase, ITT)
English: Tell your doctor if you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby.
Danish: Fortæl lægen, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: In patients treated with levofloxacin, determination of opiates in urine may give false-positive results.
Danish: Hos patienter, der behandles med levofloxacin, kan bestemmelse af opiater i urin give falsk positive resultater.
English: Clostridium difficile-associated disease
Danish: Clostridium difficile-forbundet sygdom
English: Pain (including pain in back, chest and extremities)
Danish: Smerter (herunder smerter i ryg, bryst og ekstremiteter)
English: Levofloxacin concentrations were about 13% higher in the presence of fenbufen than when administered alone.
Danish: Levofloxacinkoncentrationer var ca. 13% højere ved tilstedeværelse af fenbufen, end når det blev administreret alene.
English: The information that appears on the ampoule is:
Danish: Oplysningerne på ampullen er:
English: • Congenital long QT syndrome.
Danish: • Medfødt langt QT-syndrom.
English: Currently available data are described in sections 4.8, 5.1, 5.2 and 5.3 but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.