FrancophonIA/ELRC3.0 huggingface dataset:
English: HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Danish: HDPE-flasker med børnesikret lukning af polypropylen i æsker med 90 tabletter.
English: Zebinix 400 mg tablets are white, circular and biconvex.
Danish: Zebinix 400 mg tabletter er hvide, runde og bikonvekse.
English: EU/1/09/514/012 20 tablets - ALU/ALU blister EU/1/09/514/013 30 tablets - ALU/ALU blister EU/1/09/514/014 60 tablets - ALU/ALU blister EU/1/09/514/015 90 tablets - ALU/ALU blister EU/1/09/514/016 20 tablets - PVC/ALU blister EU/1/09/514/017 30 tablets - PVC/ALU blister EU/1/09/514/018 60 tablets - PVC/ALU blister EU/1/09/514/019 90 tablets - PVC/ALU blister
Danish: EU/1/09/514/012 20 tabletter - ALU/ALU-blisterkort EU/1/09/514/013 30 tabletter - ALU/ALU-blisterkort EU/1/09/514/014 60 tabletter - ALU/ALU-blisterkort EU/1/09/514/015 90 tabletter - ALU/ALU-blisterkort EU/1/09/514/016 20 tabletter - PVC/ALU-blisterkort EU/1/09/514/017 30 tabletter - PVC/ALU-blisterkort EU/1/09/514/018 60 tabletter - PVC/ALU-blisterkort EU/1/09/514/019 90 tabletter - PVC/ALU-blisterkort
English: Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for eslicarbazepinacetat, andre carboxamidderivater (fx carbamazepin, oxcarbazepin) eller over for et eller flere af hjælpestofferne anført i pkt.
English: • Inflamed gums or toothache;
Danish: • nældefeber (hududslæt med kløe).
English: Constipation, dyspepsia, gastritis, abdominal pain, dry mouth, abdominal discomfort, abdominal distension, gingivitis , melaena, toothache
Danish: Obstipation, dyspepsi, gastritis, abdominalsmerter, mundtørhed, abdominalgener, oppustethed, gingivitis, melæna, tandpine
English: Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in post-marketing experience with Zebinix treatment.
Danish: Alvorlige kutane bivirkninger (SCARS), herunder Stevens-Johnsons syndrom (SJS)/toksisk epidermal nekrolyse (TEN) samt lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS), som kan være livstruende eller letale, er rapporteret efter markedsføring ved behandling med Zebinix.
English: • Feeling sick or vomiting;
Danish: • kvalme eller opkastning
English: Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience in patients treated with Zebinix.
Danish: Alvorlige og mulig livstruende hudreaktioner, herunder Stevens-Johnsons syndrom/toksisk epidermal nekrolyse, lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS) er blevet rapporteret efter markedsføring, hos patienter behandlet med Zebinix.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20 or 60 tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 20 eller 60 tabletter
English: In children from 2 to 6 years of age, the use of eslicarbazepine acetate is not recommended.
Danish: Eslicarbazepinacetat anbefales ikke til børn i alderen fra 2 til 6 år.
English: Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Pharmacotherapeutic group: Antiepileptics, carboxamide derivatives, ATC code: N03AF04
Danish: ATC-kode: N03AF04
English: Dizziness, somnolence
Danish: Svimmelhed, døsighed
English: Children with 60 kg or more body weight should take the same dose as adults.
Danish: Børn med en kropsvægt på 60 kg eller mere skal tage den samme dosis som voksne.
English: BIAL - Portela & Cª , SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
Danish: BIAL - Portela & Cª, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal Tlf.: +351 22 986 61 00
English: How to take Zebinix
Danish: Sådan skal De tage Zebinix
English: • Blood tests showing that you have low levels of sodium in your blood;
Danish: • lavt indhold af natrium i blodprøver
English: The prevalence of HLA-B*1502 carrier is about 10% in Han Chinese and Thai populations.
Danish: Omkring 10 % af personer af hankinesisk og thailandsk oprindelse er bærere af HLA-B*1502-allelen.
English: Therefore it is recommended that you use other forms of safe and effective contraception, when taking Zebinix up to the end of the current menstrual cycle after stopping treatment.
Danish: De bør derfor bruge anden sikker prævention under behandling med Zebinix og frem til afslutningen på den aktuelle menstruationscyklus efter endt behandling.
English: Liver centrilobular hypertrophy was seen in repeated-dose toxicity studies in mice and rats and an increased incidence of liver tumours was observed in the carcinogenicity study in mice; these findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving eslicarbazepine acetate.
Danish: Der sås hepatisk centrilobulær hypertrofi i toksicitetsundersøgelser efter gentagne doser hos mus og rotter og en øget incidens af levertumorer i karcinogenicitetsstudiet hos mus.
English: • Liver problems;
Danish: • leverproblemer
English: Very common
Danish: Almindelige Ikke almindelige
English: EU/1/09/514/001 7 tablets - ALU/ALU blister EU/1/09/514/002 14 tablets - ALU/ALU blister EU/1/09/514/003 28 tablets - ALU/ALU blister EU/1/09/514/004 7 tablets - PVC/ALU blister EU/1/09/514/005 14 tablets - PVC/ALU blister EU/1/09/514/006 28 tablets - PVC/ALU blister
Danish: EU/1/09/514/001 7 tabletter - ALU/ALU-blisterkort EU/1/09/514/002 14 tabletter - ALU/ALU-blisterkort EU/1/09/514/003 28 tabletter - ALU/ALU-blisterkort EU/1/09/514/004 7 tabletter - PVC/ALU-blisterkort EU/1/09/514/005 14 tabletter - PVC/ALU-blisterkort EU/1/09/514/006 28 tabletter - PVC/ALU-blisterkort
English: Once inserted, the bottle adapter must not be removed from the bottle.
Danish: Det kan muligvis være nødvendigt at påføre et vist tryk for at få den sat ordentlig i. Når flaskeadapteren er isat, må den ikke fjernes fra flasken igen.
English: Eslicarbazepine acetate was tested at doses of 1,200 mg and 1,600 mg once-daily.
Danish: Eslicarbazepinacetat blev testet ved doser på 1.200 mg og 1.600 mg en gang dagligt.
English: (increase of ≥25%) compared to Baseline Parts III-V was 25.7%.
Danish: Den samlede andel af patienter med eksacerbation (stigning på ≥25 %) var 25,7 % sammenlignet med del III-V ved baseline.
English: • Feeling generally weak, unwell or having chills;
Danish: • general mathed, utilpashed eller kuldegysninger
English: Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4).
Danish: Alvorlige kutane bivirkninger (SCARS), herunder Stevens-Johnsons syndrom (SJS)/toksisk epidermal nekrolyse (TEN) samt lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS), er rapporteret efter markedsføring ved behandling med Zebinix (se pkt.
English: Zebinix 800 mg tablets Eslicarbazepine acetate
Danish: Zebinix 800 mg tabletter Eslicarbazepinacetat
English: Diplopia, vision blurred
Danish: Diplopi, uskarpt syn
English: EU/1/09/514/007 30 tablets - ALU/ALU blister EU/1/09/514/008 60 tablets - ALU/ALU blister EU/1/09/514/009 30 tablets - PVC/ALU blister EU/1/09/514/010 60 tablets - PVC/ALU blister
Danish: EU/1/09/514/007 30 tabletter - ALU/ALU-blisterkort EU/1/09/514/008 60 tabletter - ALU/ALU-blisterkort EU/1/09/514/009 30 tabletter - PVC/ALU-blisterkort EU/1/09/514/010 60 tabletter - PVC/ALU-blisterkort
English: Zebinix 200 mg tablets Eslicarbazepine acetate
Danish: Zebinix 200 mg tabletter Eslicarbazepinacetat
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
Danish: Tlf.: +351 22 986 61 00 Fax: +351 22 986 61 99 E-mail: info@bial.com
English: If signs and symptoms suggestive of these reactions appear, Zebinix should be withdrawn immediately and an alternative treatment considered (as appropriate).
Danish: Zebinix skal straks seponeres, og en alternativ behandling skal overvejes (efter behov), hvis der opstår tegn og symtomer der tyder på disse reaktioner.
English: Zebinix is used: • on its own (monotherapy) in adult patients with newly diagnosed epilepsy
Danish: • alene (monoterapi) til voksne, hvor epilepsi er blevet diagnosticeret for nyligt
English: • Difficulty in sleeping;
Danish: • søvnbesvær
English: Eslicarbazepine acetate was tested at once-daily doses of 800 mg, 1,200 mg and 1,600 mg.
Danish: Eslicarbazepinacetat blev testet ved doser på 800 mg, 1.200 mg og 1.600 mg en gang dagligt.
English: As clinical data are limited in patients with mild to moderate hepatic impairment and pharmacokinetic and clinical data are missing in patients with severe hepatic impairment, eslicarbazepine acetate should be used with caution in patients with mild to moderate hepatic impairment and is not recommended in patients with severe hepatic impairment.
Danish: Der foreligger begrænsede kliniske data fra patienter med let til moderat nedsat leverfunktion, og der mangler kliniske data fra patienter med alvorligt nedsat leverfunktion.
English: • Seizures;
Danish: • forstoppelse
English: It is not known whether it passes into breast milk.
Danish: Det vides ikke, om Zebinix udskilles i mælken hos mennesker.
English: White oblong tablets, engraved ‘ESL 600'on one side and scored on the other side, with a length of 17.3 mm.
Danish: Hvide, aflange tabletter med 'ESL 600' præget på den ene side og delekærv på den anden side med en længde på 17,3 mm. Tabletten kan deles i to lige store doser.
English: zebinix 200 mg (outer pack only)
Danish: zebinix 200 mg (kun på den ydre emballage)
English: Contains methyl parahydroxybenzoate (E218) and sulphites See leaflet for further information
Danish: Indeholder methylparahydroxybenzoat (E218) og sulfitter.
English: Zebinix 400 mg tablets Eslicarbazepine acetate
Danish: Zebinix 400 mg tabletter Eslicarbazepinacetat
English: Zebinix 600 mg tablets Eslicarbazepine acetate
Danish: Zebinix 600 mg tabletter Eslicarbazepinacetat
English: White oblong tablets, engraved 'ESL 200' on one side and scored on the other side, with a length of 11 mm.
Danish: Hvide, aflange tabletter med 'ESL 200' præget på den ene side og delekærv på den anden side med en længde på 11 mm. Tabletten kan deles i to lige store doser.
English: zebinix 800 mg (outer pack only)
Danish: zebinix 800 mg (kun på den ydre emballage)
English: Zebinix 200 mg tablets
Danish: Zebinix 200 mg tabletter
English: • if you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue.
Danish: • hvis De får blærer eller afskalning af hud og/eller slimhinder, udslæt, besvær med at synke eller trække vejret eller hævelser i læber, øjenlåg, ansigt, hals eller tunge, da der kan være tale om en allergisk reaktion.
English: White oblong tablets, engraved ‘ESL 800'on one side and scored on the other side, with a length of 19 mm.
Danish: Hvide, aflange tabletter med 'ESL 800' præget på den ene side og delekærv på den anden side med en længde på 19 mm. Tabletten kan deles i to lige store doser.
English: Zebinix 800 mg tablets
Danish: Zebinix 800 mg tabletter
English: The tablets have ‘ESL 600'engraved on one side and are scored on the other side, with a length of 17.3 mm.
Danish: Tabletterne har 'ESL 600' præget på den ene side og delekærv på den anden side med en længde på 17,3 mm. Tabletten kan deles i to lige store doser.
English: Zebinix 800 mg tablets are white and oblong.
Danish: Zebinix 800 mg tabletter er hvide og aflange.
English: zebinix 600 mg (outer pack only)
Danish: zebinix 600 mg (kun på den ydre emballage)
English: The tablets have ‘ESL 800'engraved on one side and are scored on the other side, with a length of 19 mm.
Danish: Tabletterne har 'ESL 800' præget på den ene side og delekærv på den anden side med en længde på 19 mm. Tabletten kan deles i to lige store doser.
English: Zebinix 200 mg tablets are white and oblong.
Danish: Zebinix 200 mg tabletter er hvide og aflange.
English: In the age group from 6 to 11 years of age, the most common adverse reaction observed in more than two patients treated with eslicarbazepine acetate were diplopia (9.5%), somnolence (7.4%), diziness (6.3%), convulsion (6.3%) and nausea (3.2%); in the age group from 12 to 18 years were somnolence (7.4%), vomiting (4.2%), diplopia (3.2%) and fatigue (3.2%).
Danish: I aldersgruppen fra 12 til 18 år var det døsighed (7,4 %), opkastning (4,2 %), diplopi (3,2 %) og træthed (3,2 %).
English: Zebinix 400 mg tablets
Danish: Zebinix 400 mg tabletter
English: Each tablet contains 200 mg of eslicarbazepine acetate.
Danish: Hver tablet indeholder 200 mg eslicarbazepinacetat.
English: Zebinix 600 mg tablets
Danish: Zebinix 600 mg tabletter
English: Zebinix 600 mg tablets are white and oblong.
Danish: Zebinix 600 mg tabletter er hvide og aflange.
English: Rash
Danish: • rysten
English: Package leaflet: Information for the user Zebinix 200 mg tablets
Danish: Indlægsseddel: Information til brugeren Zebinix 200 mg tabletter
English: The maximum is 1,200 mg once daily.
Danish: 1.200 mg/dag.
English: Similar to adults, eslicarbazepine acetate is extensively converted to eslicarbazepine.
Danish: Eslicarbazepinacetat omdannes tilsvarende som hos voksne i kraftig grad til eslicarbazepin.
English: • Constipation;
Danish: Træthed,
English: Package leaflet: Information for the user Zebinix 800 mg tablets
Danish: Indlægsseddel: Information til brugeren Zebinix 800 mg tabletter
English: The tablets have ‘ESL 200'engraved on one side and are scored on the other side, with a length of 11 mm.
Danish: Tabletterne har 'ESL 200' præget på den ene side og delekærv på den anden side med en længde på 11 mm. Tabletten kan deles i to lige store doser.
English: Package leaflet: Information for the user Zebinix 400 mg tablets
Danish: Indlægsseddel: Information til brugeren Zebinix 400 mg tabletter
English: The pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment (see sections 4.4 and 5.2) and use in these patients is, therefore, not recommended.
Danish: Eslicarbazepinacetats farmakokinetik er ikke undersøgt hos patienter med alvorligt nedsat leverfunktion (se pkt.
English: Package leaflet: Information for the user Zebinix 600 mg tablets
Danish: Indlægsseddel: Information til brugeren Zebinix 600 mg tabletter
English: Renal impairment
Danish: • unormal følesans
English: What you need to know before you take Zebinix 3.
Danish: Det skal De vide, før De begynder at tage Zebinix Sådan skal De tage Zebinix Bivirkninger
English: Cutaneous reactions
Danish: Hudreaktioner
English: • Headache;
Danish: • hårtab
English: • Bone metabolism disorder;
Danish: • forstyrrelser i knogledannelsen
English: • Nosebleed;
Danish: • klodsethed
English: • Feeling unsteady or having a sensation of spinning or floating;
Danish: • usikker på benene eller en følelse af, at det hele drejer rundt
English: White circular biconvex tablets, engraved ‘ESL 400'on one side and scored on the other side, with a diameter of 11 mm..
Danish: Hvide, runde, bikonvekse tabletter med 'ESL 400' præget på den ene side og delekærv på den anden side med en diameter på 11 mm. Delekærven er der, for at tabletten kan deles, så den er nemmere at sluge, ikke for at kunne dosere to halve tabletter.
English: Therefore, their occurrence after treatment with eslicarbazepine acetate cannot be excluded.
Danish: De er dog indberettet for oxcarbazepin, og det kan derfor ikke udelukkes, at de kan forekomme efter behandling med eslicarbazepinacetat.
English: If you take more Zebinix than you should
Danish: Hvis De har taget for meget Zebinix
English: The National Competent Authorities of Member States or Reference Member States if applicable, shall ensure that the following condition is fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaterne sikrer, at indehaveren (indehaverne) af markedsføringstilladelse opfylder følgende betingelse:
English: Suspension of the marketing authorisations should be lifted when bioequivalence to an EU Reference Medicinal Product has been established based on a bioequivalence study conducted visà-vis the EU Reference Medicinal Product.
Danish: Suspenderingen af markedsføringstilladelsen ophæves, når der er påvist bioækvivalens med et EUreferencelægemiddel i en bioækvivalensundersøgelse.
English: Annex III Condition for lifting the suspension of the Marketing Authorisations
Danish: Bilag III Betingelse for ophævelse af suspenderingen af markedsføringstilladelserne
English: The recommended dose is 10 mg per kilogram bodyweight.
Danish: Den anbefalede dosis er 10 mg pr. kilo legemsvægt.
English: The full EPAR for Zinplava can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zinplava findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Zinplava.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zinplava.
English: A new episode of diarrhoea was defined as 3 or more loose stools in 24 or fewer hours.
Danish: Et nyt tilfælde af diarré blev defineret som 3 eller flere tilfælde af løs afføring i løbet af højst 24 timer.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Zinplava'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 Zinplava opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Other information about Zinplava
Danish: Andre oplysninger om Zinplava
English: In the second study, figures were 16% (62 out of 395) for Zinplava and 26% (97 out of 378) for placebo.
Danish: I den anden undersøgelse var tallene 16 % (62 ud af 395) for Zinplava-gruppen og 26 % (97 ud af 378) for placebogruppen.
English: It is given as a single infusion lasting around 1 hour.
Danish: Zinplava gives som en enkelt infusion, der varer ca. en time.
English: The most common side effects with Zinplava (seen in more than 4 in 100 patients) are nausea (feeling sick), diarrhoea, fever and headache.
Danish: De hyppigste bivirkninger ved Zinplava (som optræder hos flere end 4 ud af 100 patienter) er kvalme, diarré, feber og hovedpine.
English: What is Zinplava and what is it used for?
Danish: Hvad er Zinplava, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Zinplava?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zinplava?
English: After an initial infection, some dormant forms of the bacteria (spores) may persist in the body and eventually produce further toxins, causing the symptoms to return.
Danish: Efter den første infektion kan der være sovende former af bakterien (sporer) tilbage i kroppen, og de kan producere yderligere toksiner, der får symptomerne til at vende tilbage.
English: Similar effects have been seen in patients on placebo.
Danish: Lignende bivirkninger er set hos patienter, der har fået placebo.
English: It is not intended to provide practical advice on how to use Zinplava.
Danish: Det er ikke en praktisk vejledning i, hvordan Zinplava bør anvendes.
English: Zinplava is generally well tolerated with side effects similar to those observed in patients on placebo.
Danish: Zinplava er generelt veltolereret med bivirkninger svarende til dem, der er set hos patienter, der har fået placebo.
English: Why is Zinplava approved?
Danish: Hvorfor blev Zinplava godkendt?
English: The effect was mainly seen in patients at higher risk of C. difficile infection coming back (such as older patients or those with a weakened immune system).
Danish: Virkningen sås hovedsageligt hos patienter med en høj risiko for tilbagevenden af C. difficile-infektion (f.eks. ældre patienter eller patienter med et svækket immunforsvar).
English: In the first study, 17% of patients given Zinplava (67 out of 386) had a new episode of diarrhoea in the 12 weeks after treatment compared with 28% of patients given placebo (109 out of 395).
Danish: I den første undersøgelse oplevede 17 % af de patienter, der fik Zinplava (67 ud af 386), et nyt tilfælde af diarré inden for 12 uger efter behandlingen sammenholdt med 28 % af dem, der fik placebo (109 ud af 395).
English: For more information about treatment with Zinplava, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zinplava, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Zinplava?
Danish: Hvilke risici er der forbundet med Zinplava?
English: Zinplava has been shown to be effective at preventing recurrence of C. difficile infection, particularly in patients at high risk of the infection coming back (which occurs in about 15 to 35% of cases and is particularly difficult to treat).
Danish: Det er påvist, at Zinplava er effektivt til at forhindre tilbagevenden af C. difficile-infektion, navnlig hos patienter med høj risiko for tilbagevenden af infektionen (tilbagevenden ses hos ca. 15-35 % af patienterne og er særligt vanskeligt at behandle).
English: C. difficile bacteria produce toxins that damage the lining of the gut causing diarrhoea which may be severe.
Danish: C. difficile-bakterien producerer toksiner, der skader slimhinden i tarmen og forårsager diarré, som kan være svær.
English: For the full list of all side effects and restrictions with Zinplava, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Zinplava fremgår af indlægssedlen.
English: Zinplava is a medicine used in adults who have infections due to bacteria called Clostridium difficile that cause severe diarrhoea.
Danish: Zinplava er et lægemiddel, der anvendes hos voksne med infektioner, der skyldes bakterien Clostridium difficile, og som kan fremkalde svær diarré.
English: For practical information about using Zinplava, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zinplava, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: antibody (a type of protein) that has been designed to attach to these toxins, blocking their action, thereby preventing further damage and diarrhoea from occurring.
Danish: Bezlotoxumab er et monoklonalt antistof (en type protein), der er opbygget til at binde til disse toksiner og dermed blokere deres aktivitet, hvilket forhindrer yderligere skade og diarré.
English: Zinplava is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Danish: Zinplava fås som et koncentrat, der fortyndes til en opløsning, som gives som infusion (drop) i en vene.
English: It is used to prevent future episodes of diarrhoea in patients who are taking antibiotics to treat their C. difficile infection and who are at high risk of the infection coming back.
Danish: Lægemidlet anvendes til at forebygge nye tilfælde af diarré hos patienter, der tager antibiotika mod en Clostridium difficile-infektion, og som har en høj risiko for, at infektionen vender tilbage.