FrancophonIA/ELRC3.0 huggingface dataset:
English: Pre-operative prophylaxis of surgical site infections 20-50 mg/kg as a single pre-operative dose.
Danish: Profylaktisk inden operation mod infektioner på operationsstedet Enkeltdosis på 20-50 mg/kg præoperativt.
English: How Rocephin is given
Danish: Sådan får du Rocephin
English: Intra-abdominal infections Complicated skin and soft tissue infections Complicated urinary tract infections (including pyelonephritis)
Danish: Intra-abdominal infektion Kompliceret hud- og bløddelsinfektion Kompliceret urinvejsinfektion (inklusive pyelonefritis)
English: Headache Dizziness
Danish: Ødem Kuldegysninger
English: Indications for neonates, infants and children 15 days to 12 years (< 50 kg) that require specific dosage schedules:
Danish: Indikationer, hvor særlige dosisskemaer for nyfødte, spædbørn og børn i aldersgruppen 15 dage til 12 år (<50 kg) er påkrævet:
English: Calcium-containing diluents, such as Ringer's solution or Hartmann's solution, should not be used to reconstitute Rocephin vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form.
Danish: Calciumsholdige opløsningsmidler såsom Ringers opløsning og Hartmanns opløsning, må ikke bruges til at rekonstituere Rocephin i hætteglas eller til videre fortynding af rekonstitueret hætteglas til intravenøs administration, da der kan dannes et præcipitat.
English: • Inflammation of the mucus lining of the mouth (stomatitis).
Danish: • Betændelse i mundslimhinden (stomatitis).
English: • A lumpy rash (hives) that may cover a lot of your body, feeling itchy and swelling.
Danish: • Nældefeber, som kan dække en stor del af kroppen med kløe og hævelse.
English: Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion and the infusion lines flushed between solutions (see sections 4.3, 4.8, 5.2 and 6.2).
Danish: Alternativt kan infusion af TPN stoppes, mens der gives ceftriaxon, og infusionsslangen skylles mellem de to infusioner (se pkt.
English: In particular diluents containing calcium, (e.g. Ringer's solution, Hartmann's solution) should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form.
Danish: Især calciumholdige infusionsvæsker (f.eks. Ringers opløsning og Hartmanns opløsning) bør ikke bruges til at rekonstituere ceftriaxon i hætteglas eller til videre fortynding af rekonstitueret opløsning til intravenøs administration, da der kan dannes et præcipitat.
English: • Feeling sick or being sick.
Danish: • Kvalme eller opkastning.
English: How to store Rocephin [To be completed nationally]
Danish: Rocephin indeholder: [Udfyldes nationalt]
English: Hospital acquired pneumonia Complicated skin and soft tissue infections Infections of bones and joints
Danish: Nosokomiel pneumoni Kompliceret hud- og bløddelsinfektion
English: 250 mg powder for solution for injection Powder for solution for injection [To be completed nationally]
Danish: 250 mg pulver til injektionsvæske, opløsning Pulver til injektionsvæske, opløsning [Udfyldes nationalt]
English: Galactosaemia test false positiveb
Danish: Falsk-positiv galaktosæmitestb
English: 100 mg/kg (max 4 g)
Danish: 100 mg/kg (maks.
English: Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium (see section 4.3).
Danish: behandling med calciumholdige intravenøse infusionsvæsker, inklusive vedvarende calciumholdige infusionsvæsker såsom parenteral ernæring, på grund af risiko for udfældning af ceftriaxoncalcium (se pkt.
English: Germany, Greece, Hungary, Ireland, Netherlands, Portugal: Rocephin Italy: Rocefin
Danish: Danmark, Island, Sverige: Rocephalin Tyskland, Grækenland, Malta, Holland, Portugal, Rumænien: Rocephin Italien: Rocefin
English: Diarrhoeab Loose stools
Danish: Mave-tarm-kanalen Diarréb Løs afføring
English: Anaerobes
Danish: Anaerobe
English: Severe allergic reactions (not known, frequency cannot be estimated from the available data) If you have a severe allergic reaction, tell a doctor straight away.
Danish: Svære allergiske reaktioner (hyppigheden kendes ikke - kan ikke vurderes ud fra de foreliggende data)
English: Diluents containing calcium, (e.g. Ringer's solution or Hartmann's solution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form.
Danish: Calciumsholdige opløsningsmidler (f.eks. Ringers opløsning og Hartmanns opløsning) må ikke bruges til at rekonstituere ceftriaxon i hætteglas eller til videre fortynding af rekonstitueret ceftriaxon til intravenøs administration, da der kan dannes et præcipitat.
English: Adults, older people and children aged 12 years and over with a body weight greater than or equal to 50 kilograms (kg):
Danish: Ældre patienter, voksne og børn i aldersgruppen 12 år og derover med en kropsvægt på 50 kilo og derover:
English: Listeria monocytogenes
Danish: Enterococcus spp Listeria monocytogenes
English: 80-100 mg/kg (max 4 g)
Danish: 80-100 mg/kg (maks.
English: In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised.
Danish: Omhyggelig klinisk monitorering for sikkerhed og effekt tilrådes hos patienter med samtidig svært nedsat lever- og nyrefunktion.
English: Rocephin is used to treat infections of the brain (meningitis).
Danish: Rocephin bruges til at behandle infektioner i:
English: 2 g powder for solution for infusion Powder for solution for infusion [To be completed nationally]
Danish: 2 g pulver til infusionsvæske, opløsning Pulver til infusionsvæske, opløsning [Udfyldes nationalt]
English: Intra-abdominal infections Complicated urinary tract infections (including pyelonephritis)
Danish: Intra-abdominal infektion Kompliceret urinvejsinfektion (inklusive pyelonefritis)
English: Pharmacotherapeutic group: Antibacterials for systemic use, Third-generation cephalosporins, ATC code: J01DD04.
Danish: Farmakoterapeutisk klassifikation: Antibiotika til systemisk brug.
English: Ceftriaxone dosage*
Danish: Ceftriaxondosis* Behandlingshyppighed**
English: In patients with hepatic impairment, the elimination half-life of ceftriaxone is not increased, due to a compensatory increase in renal clearance.
Danish: På grund af den kompensatoriske stigning i renal clearance øges eliminationshalveringstiden for ceftriaxon ikke hos patienter med nedsat leverfunktion.
English: You have ever had problems with your gut, in particular colitis (inflammation of the bowel).
Danish: • nogensinde har haft problemer med tarmene, særligt tyktarmsbetændelse
English: For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age
Danish: Behandling af akut eksacerbation af kronisk obstruktiv lungesygdom hos voksne Behandling af dissemineret Lyme-borreliose (tidligt stadie (II) og sent stadie (III)) hos voksne og børn, herunder nyfødte fra 15 dage og ældre Profylaktisk mod infektioner før kirurgiske indgreb Neutropene patienter med feber, hvor der er mistanke om bakteriel infektion Patienter med bakteriæmi, der opstår i forbindelse med, eller hvor der er mistanke om forbindelse med nogen af ovenstående infektioner
English: Treatment frequency
Danish: Behandlingsvarighed
English: 50-100 mg/kg (Max 4 g)
Danish: 50-100 mg/kg (maks.
English: Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem.
Danish: Der er ved obduktion konstateret udfældning af ceftriaxoncalcium i lunger og nyrer.
English: Community acquired pneumonia Hospital acquired pneumonia
Danish: Ikke-nosokomiel pneumoni Nosokomiel pneumoni
English: the lungs.
Danish: • lungerne
English: Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions including total parenteral nutrition (see section 4.2, 4.3, 4.4 and 4.8).
Danish: Ceftriaxon og calciumholdige opløsninger herunder total parenteral ernæring må ikke blandes eller administreres samtidigt (se pkt.
English: If you are given more Rocephin than you should
Danish: Hvis du har fået for meget Rocephin
English: Cases of pancreatitis, possibly of biliary obstruction aetiology, have been reported in patients treated with Rocephin (see section 4.8).
Danish: Der er rapporteret tilfælde af pankreatitis, hvor ætiologien muligvis er galdeobstruktion (se pkt.
English: • You have gall stones or kidney stones
Danish: • har galdesten eller nyresten
English: Management of neutropenic patients with fever that is suspected to be due to a bacterial infection Bacterial endocarditis Bacterial meningitis * In documented bacteraemia, the higher end of the recommended dose range should be considered.
Danish: Neutropene patienter med feber, hvor der er mistanke om bakteriel infektion Bakteriel endocarditis Bakteriel meningitis
English: Anaphylactoid reaction
Danish: Kvalme Opkastning
English: People with liver and kidney problems
Danish: Patienter med lever- eller nyreproblemer
English: the skin or soft tissues.
Danish: • hud og bløddele
English: If you forget to use Rocephin
Danish: Hvis du ikke har fået Rocephin
English: 50-80 mg/kg
Danish: 50-80 mg/kg 1 x dagligt
English: System Organ Class
Danish: Systemorganklasse Almindelig Ualmindelig Sjælden
English: In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection
Danish: Infektion i knogler og led Neutropene patienter med feber, hvor der er mistanke om bakteriel infektion
English: Agranulocytosis
Danish: Hæmolytisk anæmib Agranulocytose
English: Do not stop taking Rocephin unless your doctor tells you to.
Danish: Behandlingen med Rocephin må kun stoppes efter aftale med lægen.
English: Rocephin and associated names (see Annex I) 2 g Powder for Solution for Infusion Rocephin and associated names (see Annex I) 2 g Powder for Solution for Injection or Infusion Rocephin and associated names (see Annex I) 1 g Powder for Solution for Injection or Infusion Rocephin and associated names (see Annex I) 1 g Powder and Solvent for Solution for Injection Rocephin and associated names (see Annex I) 500 mg Powder and Solvent for Solution for Injection Rocephin and associated names (see Annex I) 250 mg Powder and Solvent for Solution for Injection Rocephin and associated names (see Annex I) 250 mg Powder for Solution for Injection [See Annex I - To be completed nationally]
Danish: Rocephin og associerede navne (se Bilag I) 2 g Pulver til infusionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 2 g Pulver til injektions-/infusionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 1 g Pulver til injektions-/infusionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 1 g Pulver og solvens til injektionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 500 mg Pulver og solvens til injektionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 250 mg Pulver og solvens til injektionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 250 mg Pulver til injektionsvæske, opløsning [Se bilag 1 - udfyldes nationalt]
English: 20-50 mg/kg
Danish: 20-50 mg/kg 1 x dagligt
English: Rocephin and associated names (see Annex I) 2 g Powder for Solution for Infusion Rocephin and associated names (see Annex I) 2 g Powder for Solution for Injection or Infusion Rocephin and associated names (see Annex I) 1 g Powder for Solution for Injection or Infusion Rocephin and associated names (see Annex I) 1 g Powder and Solvent for Solution for Injection Rocephin and associated names (see Annex I) 500 mg Powder and Solvent for Solution for Injection Rocephin and associated names (see Annex I) 250 mg Powder and Solvent for Solution for Injection Rocephin and associated names (see Annex I) 250 mg Powder for Solution for Injection
Danish: Rocephin og associerede navne (se Bilag I) 2 g Pulver til infusionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 2 g Pulver til injektions-/infusionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 1 g Pulver til injektions-/infusionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 1 g Pulver og solvens til injektionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 500 mg Pulver og solvens til injektionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 250 mg Pulver og solvens til injektionsvæske, opløsning Rocephin og associerede navne (se Bilag I) 250 mg Pulver til injektionsvæske, opløsning
English: Granulocytopenia Anaemia Coagulopathy
Danish: Granulocytopeni Anæmi
English: Peptostreptococcus spp.
Danish: Peptostreptococcus spp Clostridium perfringens
English: Patients with hepatic impairment
Danish: Hovedpine Svimmelhed
English: A trigger or cofactor of Rocephin-related biliary precipitation cannot be ruled out.
Danish: Rocephin-relateret udfældning i galden kan ikke udelukkes som en udløsende eller medvirkende faktor.
English: the urinary tract and kidneys.
Danish: • urinveje og nyrer
English: bones and joints.
Danish: • knogler og led
English: Talk to your doctor or pharmacist or nurse before your child is administered Rocephin if:
Danish: Kontakt lægen, apoteketspersonalet eller sundhedspersonalet, inden dit barn får Rocephin, hvis barnet fornylig har fået eller skal have infusionsvæsker med produkter, der indeholder calcium.
English: Mode of action
Danish: Erythema multiforme
English: Treponema pallidum
Danish: Koagulopati
English: • Pruritis (itching).
Danish: • hjernen (meningitis)
English: • A high temperature (fever).
Danish: • Feber.
English: BATCH NUMBER [To be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER [Udfyldes nationalt]
English: Ceftriaxone-calcium salt precipitation
Danish: Udfældning af ceftriaxoncalcium
English: If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straight away.
Danish: Kontakt omgående lægen eller nærmeste sygehus, hvis du ved en fejl har fået mere Rocephin, end der er ordineret.
English: • Inflammation of the large bowel (colon).
Danish: • maven eller bugvæggen (bughindebetændelse).
English: Rocephin 250 mg Powder for Solution for Injection Malta, Netherlands, United Kingdom: Rocephin [See Annex I - To be completed nationally] This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Danish: Rocephin 250 mg pulver til injektionsvæske, opløsning Malta, Holland, Storbritannien: Rocephin
English: the middle ear.
Danish: • mellemøret
English: No side effects have been identified.
Danish: Der er ikke fundet nogen bivirkninger.
English: This is a summary of the European public assessment report (EPAR) for Praxbind.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Praxbind.
English: The full EPAR and risk management plan summary for Praxbind can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Praxbind findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Praxbind
Danish: Andre oplysninger om Praxbind
English: At the time of authorisation Praxbind has not been associated with any specific side effects.
Danish: På godkendelsestidspunktet er Praxbind ikke forbundet med nogen specifikke bivirkninger.
English: A risk management plan has been developed to ensure that Praxbind is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Praxbind anvendes så sikkert som muligt.
English: The medicine can only be obtained with a prescription and it is for use in hospital only.
Danish: Lægemidlet fås kun på recept og må kun anvendes i hospitalsomgivelser.
English: A second 5-g dose may be given as two further injections or infusions, if needed.
Danish: Der kan gives endnu en dosis på 5 g ved to yderligere injektioner eller infusioner, hvis det er nødvendigt.
English: Praxbind has been investigated in three main studies involving 141 healthy adults who previously received dabigatran.
Danish: Praxbind er undersøgt i tre hovedundersøgelser med deltagelse af 141 raske voksne forsøgspersoner, der tidligere havde fået dabigatran.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Praxbind's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Praxbind opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: In a still ongoing trial, an interim analysis showed similar results in 123 patients who had uncontrolled bleeding or required emergency surgery while using Pradaxa.
Danish: I en stadig igangværende undersøgelse viste en interimanalyse tilsvarende resultater hos 123 patienter, der fik ukontrolleret blødning eller måtte have foretaget et akut kirurgisk indgreb, mens de anvendte Pradaxa.
English: What is Praxbind and what is it used for?
Danish: Hvad er Praxbind, og hvad anvendes det til?
English: A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen).
Danish: Et monoklonalt antistof er et protein, der er udformet, så det genkender og bindes til en særlig struktur (et antigen).
English: The main studies showed that Praxbind is effective at neutralising the effects of Pradaxa, and its action is rapid, complete and sustained.
Danish: Hovedundersøgelserne viste, at Praxbind er effektivt til at neutralisere virkningerne af Pradaxa, og at dets virkning er hurtig, fuldstændig og vedholdende.
English: What measures are being taken to ensure the safe and effective use of Praxbind?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Praxbind?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Praxbind, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Praxbind, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: It is not intended to provide practical advice on how to use Praxbind.
Danish: Det er ikke en praktisk vejledning i, hvordan Praxbind bør anvendes.
English: Why is Praxbind approved?
Danish: Hvorfor er Praxbind blevet godkendt?
English: The extent of Praxbind's benefit depends on the patient's overall health, the severity of bleeding and the location of bleeding.
Danish: Fordelene ved Praxbind afhænger af patientens generelle helbredstilstand, blødningens alvorlighed og hvor blødningen findes.
English: In the studies, volunteers received either Praxbind or placebo (a dummy treatment) after treatment with Pradaxa for 3.5 days.
Danish: I undersøgelserne fik forsøgspersonerne enten Praxbind eller virkningsløs behandling (placebo) efter behandling med Pradaxa i 3,5 dage.
English: Most patients in the study were taking Pradaxa to prevent stroke due to an ‘abnormal heart beat' (atrial fibrillation).
Danish: Størstedelen af patienterne i undersøgelserne var i behandling med Pradaxa for at forebygge slagtilfælde forårsaget af "abnorm hjerterytme" (atrieflimren).
English: Praxbind contains the active substance idarucizumab.
Danish: Praxbind indeholder det aktive stof idarucizumab.
English: For more information about treatment with Praxbind, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Praxbind, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This rapidly stops dabigatran's anticlotting effect.
Danish: Dette standser hurtigt dabigatrans blodpropnedsættende virkning.
English: What are the risks associated with Praxbind?
Danish: Hvilke risici er der forbundet med Praxbind?
English: The recommended dose of Praxbind is 5 g given into a vein as two injections or infusions, one after the other.
Danish: Den anbefalede dosis af Praxbind er 5 g, der indgives i en vene ved to på hinanden følgende injektioner eller infusioner.
English: Results showed that Praxbind was able to completely neutralise Pradaxa's anticlotting effect within 5 minutes of use.
Danish: Resultaterne viste, at Praxbind var i stand til fuldstændig at neutralisere Pradaxas blodpropnedsættende virkning efter 5 minutters anvendelse.
English: Praxbind is a medicine used to neutralise the effects of dabigatran (the active substance of Pradaxa), a medicine that treats and prevents blood clots.
Danish: Praxbind er et lægemiddel til ophævelse af virkningerne af dabigatran (det aktive stof i lægemidlet Pradaxa), der anvendes til behandling og forebyggelse af blodpropper.
English: For practical information about using Praxbind, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Praxbind, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Praxbind is used to rapidly stop the anticlotting effect of dabigatran, before emergency surgery or in case of life-threatening bleeding.
Danish: Praxbind anvendes til hurtig standsning af den blodpropbekæmpende virkning af dabigatran, enten før akut kirurgi eller ved livstruende blødning.
English: The active substance in Praxbind, idarucizumab, is a monoclonal antibody fragment.
Danish: Det aktive stof i Praxbind, idarucizumab, er en del af et monoklonalt antistof.
English: For the information on the restrictions with Praxbind, see the package leaflet.
Danish: Oplysninger om begrænsninger med Praxbind fremgår af indlægssedlen.
English: Praxbind works by attaching firmly to dabigatran, and forming a complex in the blood.
Danish: virker ved at bindes til dabigatran og danne et kompleks i blodet.
English: What benefits of Praxbind have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Praxbind?
English: How is Praxbind used?
Danish: Hvordan anvendes Praxbind?
English: Praxbind is available as a solution for injection or infusion (drip) into a vein.
Danish: Praxbind leveres som injektionsvæske, opløsning, eller som infusionsvæske, opløsning (i drop), til indgivelse i en vene.
English: How does Praxbind work?
Danish: Hvordan virker Praxbind?
English: CVMP considerations
Danish: CVMPs overvejelser
English: However, this would be impossible to apply in field conditions.
Danish: Denne fremgangsmåde vil dog være uanvendelig under feltbetingelser.
English: This can be avoided by adding more categories, or even all possible dry period categories.
Danish: Dette kan undgås ved at tilføje flere kategorier eller endog alle de mulige kategorier af goldperioder.
English: Therefore the study design was not optimal for this approach.
Danish: Undersøgelsens udformning har således ikke været optimal for formålet.
English: The MAHs disagreed with the outcome of the procedure and referred the issue to the EMEA.
Danish: Indehaverne af markedsføringstilladelserne var uenige i resultatet af proceduren og indbragte sagen for EMEA.
English: Hence the withdrawal period calculated on the basis of such distributions is largely overestimated in this case.
Danish: Den tilbageholdelsestid, der beregnes på grundlag af en sådan fordeling, er derfor stærkt overvurderet i dette tilfælde.
English: Therefore, the recommended withdrawal period for Cobactan DC is:
Danish: Den anbefalede tilbageholdelsestid efter kælvning for Cobactan DC er således:
English: 2.1 Residue depletion in milk
Danish: 2.1 Restkoncentrationer i mælk
English: However, the aim of the study provided was to investigate only cows with a very short dry period.
Danish: Formålet med den forelagte undersøgelse har imidlertid været udelukkende at undersøge køer med en meget kort goldperiode.