FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean (SD) absolute change from baseline Effect of treatment (Wilcoxon signed-rank test)
Danish: Effekt af behandling (Wilcoxon signed rank-test)
English: Median VAS value at Baseline Median VAS value at Day 18
Danish: Gennemsnitlig VAS-værdi ved baseline Gennemsnitlig VAS-værdi på dag 18
English: - Transient confusion (a temporary inability to think clearly or concentrate) - Double vision - Altered sense of taste - Disorders of heart rhythm - Collapse - Hot flushes
Danish: - Hallucinationer (at se eller høre noget som ikke er tilstede) - Forbigående forvirring (midlertidig manglende evne til at tænke klart eller koncentrere sig) - Dobbeltsyn - Ændret smagssans
English: An updated RMP should be submitted:
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur
English: Patients who are CYP2D6 poor metabolisers may exhibit higher mexiletine blood levels (see section 5.2).
Danish: Patienter, som er dårlige metabolisatorer af CYP2D6, kan have højere koncentrationer af mexiletin i blodet (se pkt.
English: Not known: hallucinations, confusional state Nervous system disorders
Danish: Ikke kendt: hallucinationer, konfusion
English: CYP2D6 polymorphism may affect mexiletine pharmacokinetics (see section 5.2).
Danish: CYP2D6-polymorfisme kan påvirke farmakokinetikken af mexiletin (se pkt.
English: Co-administration of mexiletine and other classes of antiarrhythmics (class Ib: lidocaine, phenytoin, tocainide; class II: propranolol, esmolol, timolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol; class IV: verapamil, diltiazem) is not recommended, unless exceptionally, because of the increased risk of adverse cardiac reactions (see section 4.4).
Danish: Samtidig administration af mexiletin og andre klasser af antiarytmika (klasse Ib: lidocain, phenytoin, tocainid; klasse II: propranolol, esmolol, timolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol; klasse IV: verapamil, diltiazem) anbefales ikke undtagen i særlige tilfælde på grund af den øgede risiko for hjerterelaterede bivirkninger (se pkt.
English: - disorders of heart rhythm, see section “Warnings and precautions” for symptoms and more information; this is a common side effect, may affect up to 1 in 10 people.
Danish: - hjerterytmeforstyrrelser; dette er en almindelig bivirkning og kan påvirke op til 1 ud af 10 personer.
English: Therefore, the use of mexiletine is not recommended in this patient population (see section 4.2).
Danish: Brug af mexiletin anbefales derfor ikke hos denne patientpopulation (se pkt.
English: Namuscla 167 mg hard capsules mexiletine
Danish: Namuscla 167 mg hårde kapsler mexiletin
English: Mexiletine should not be used in patients with severe hepatic impairment (see section 4.4).
Danish: Mexiletin må ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: Therefore, mexiletine should not be used in this patient population (see section 4.2).
Danish: Mexiletin bør derfor ikke anvendes hos denne patientpopulation (se pkt.
English: Namuscla 167 mg hard capsules
Danish: Namuscla 167 mg hårde kapsler
English: Co-administration of mexiletine with a hepatic enzyme inducer (CYP1A2 inducer: omeprazole; CYP2D6 inducer: phenytoin, rifampicin) may increase the clearance and elimination rate of mexiletine due to an increased hepatic metabolism, resulting in decreased plasmatic concentrations and half-life of mexiletine.
Danish: Samtidig administration af mexiletin med et leverenzyminducerende stof (CYP1A2-inducerende stof: omeprazol; CYP2D6-inducerende stof: phenytoin, rifampicin) kan øge clearance og eliminationshastighed af mexiletin på grund af en øget metabolisme i leveren, som resulterer i reducerede plasmakoncentrationer og halveringstid af mexiletin.
English: No dosage adjustment is considered necessary in patients with mild or moderate renal impairment.
Danish: Dosisjustering til patienter med mild til moderat nedsat nyrefunktion anses ikke for nødvendig.
English: o certain antibiotics (ciprofloxacin, rifampicin), o certain antidepressants (fluvoxamine), o tizanidine (used to relax the muscles), o metformin (used against diabetes) o omeprazole (to treat stomach ulcer and gastric acid reflux).
Danish: • visse andre lægemidler: o timolol til behandling af højt tryk i øjet (glaukom) o visse antibiotika (ciprofloxacin, rifampicin) o visse antidepressiva (fluvoxamin) o tizanidin (bruges til afslapning af musklerne) o metformin (bruges til behandling af diabetes) o omeprazol (til behandling af mavesår og mavesyre-reflux (kan vise sig ved sure opstød, halsbrand eller sviende smerter i maven)).
English: Clinical Myotonia Scale - Disability Global Score Number of subjects
Danish: Klinisk myotoni-skala - Overordnet score for funktionsnedsættelse
English: Co-administration of mexiletine with a hepatic enzyme inhibitor (CYP1A2 inhibitor: ciprofloxacin, fluvoxamine, propafenone; CYP2D6 inhibitor: propafenone, quinidine) significantly increases mexiletine exposure and thus the associated risk of adverse reactions to mexiletine.
Danish: Samtidig administration af mexiletin med en leverenzymhæmmer (CYP1A2-hæmmer: ciprofloxacin, fluvoxamin, propafenon; CYP2D6-hæmmer: propafenon, quinidin) øger eksponering for mexiletin signifikant og derved den tilknyttede risiko for bivirkninger relateret til mexiletin.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg din læge eller apotekspersonalet, hvis der er noget du er i tvivl om.
English: What you need to know before you take Namuscla
Danish: Det skal du vide, før du begynder at tage Namuscla
English: Each capsule contains mexiletine hydrochloride corresponding to 166.62 mg mexiletine .
Danish: Hver kapsel indeholder mexiletinhydrochlorid svarende til 166,62 mg mexiletin.
English: Cardiac arrhythmogenic effects
Danish: Arytmogene virkninger på hjertet
English: Common: headache, paraesthesia, vision blurred Uncommon: seizure, speech disorders
Danish: Almindelig: hovedpine, paræstesi, sløret syn Ikke almindelig: krampeanfald, taleforstyrrelser Ikke kendt: diplopi, dysgeusi
English: Co-administration of mexiletine and antiarrhythmics inducing torsades de pointes (class Ia: quinidine, procainamide, disopyramide, ajmaline; class Ic: encainide, flecainide, propafenone, moricizine; class III: amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant) increases the risk of potentially lethal torsades de pointes.
Danish: Antiarytmika der fremkalder torsade de pointes (klasse Ia, Ic, III antiarytmika): Samtidig administration af mexiletin og antiarytmika der fremkalder torsade de pointes (klasse Ia: quinidin, procainamid, disopyramid, ajmalin; klasse Ic: encainid, flecainid, propafenon, moricizin; klasse III: amiodaron, sotalol, ibutilid, dofetilid, dronedaron, vernakalant) øger risikoen for potentielt dødelig torsade de pointes.
English: • HCPs should counsel patients on: o The risk of cardiac arrhythmias (informing about symptoms of arrhythmias, advising patients to contact immediately their HCP, or emergency centres, if they experience any of these symptoms);
Danish: • Sundhedsfagligt personale skal vejlede patienter om: o risikoen for hjertearytmi (informere om symptomer på arytmi, råde patienter til at kontakte det sundhedsfaglige personale eller skadestue straks, hvis de oplever nogen af disse symptomer); o risikoen for nedsat clearance af Namuscla hos patienter med nedsat leverfunktion (råde patienter til at informere det sundhedsfaglige personale, hvis de har nogen leversygdomme);
English: What Namuscla looks like and contents of the pack Namuscla hard capsules are reddish hard gelatin capsules filled with white powder.
Danish: Namuscla hårde kapsler er rødlige hårde gelatinekapsler fyldt med hvidt pulver.
English: Median value at Day 18
Danish: Gennemsnitlig værdi ved baseline Gennemsnitlig værdi på dag 18
English: Each hard capsule contains mexiletine hydrochloride corresponding to 166.62 mg of mexiletine
Danish: Hver hård kapsel indeholder mexiletinhydrochlorid svarende til 166,62 mg mexiletin.
English: • Atrial tachyarrhythmia, fibrillation or flutter
Danish: • Atrial takykardi eller hjerteflimmer
English: The experience with mexiletine in patients with severe renal impairment is limited.
Danish: Der er begrænset erfaring med mexiletin hos patienter med svært nedsat leverfunktion.
English: Colloidal anhydrous silica Magnesium stearate
Danish: Majsstivelse Silica, kolloid vandfri
English: Very common: abdominal pain
Danish: Meget almindelig: mavesmerter
English: • Patients should inform the HCP about any ongoing medications or before starting any new medication, while on treatment with Namuscla;
Danish: • patienter skal informere det sundhedsfaglige personale om igangværende brug af andre lægemidler samt om påbegyndelse af brug af andre lægemidler;
English: How to store Namuscla 6.
Danish: Sådan skal du tage Namuscla 4.
English: Namuscla 167 mg capsules mexiletine
Danish: Namuscla 167 mg kapsler mexiletin
English: The potential interactions between mexiletine and substrates of other common enzymes and transporters have not yet been assessed; it is currently contra-indicated to use mexiletine with any substrate having a narrow therapeutic window such as digoxin, lithium, phenytoin, theophylline or warfarin (see section 4.3).
Danish: Det er på nuværende tidspunkt kontraindiceret at bruge mexiletin med noget substrat, der har et snævert terapeutisk vindue, såsom digoxin, lithium, phenytoin, theophyllin eller warfarin.
English: The potential of mexiletine as a drug-drug-interaction perpetrator is unknown.
Danish: Den mulige indvirkning af mexiletine på andre lægemidler er ukendt.
English: • Patient alert card
Danish: en vejledning til sundhedsfagligt personale; Patientkort
English: Clinical Global Impression (CGI) Efficacy index Number of subjects
Danish: Effektindeks for klinisk overordnet opfattelse (Clinical Global Impression, CGI)
English: - Pulmonary fibrosis (disease of the lung) - Diarrhoea - Vomiting - Injury of the oesophagus (food pipe)
Danish: - Hjerterytmeforstyrrelser - Kollaps - Hedeture - Lungefibrose (lungesygdom) - Diarré - Opkastning - Skade i øsofagus (spiserøret)
English: CYP1A2 & CYP2D6 inhibitors
Danish: CYP1A2- og CYP2D6-hæmmere
English: Lupin Europe GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main Germany
Danish: Lupin Europe GmbH Hanauer Landstraße 139-143 60314 Frankfurt am Main Tyskland
English: Hormosan Pharma GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main Germany
Danish: Hormosan Pharma GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main Tyskland
English: • Throughout treatment with Namuscla: o In patients without cardiac abnormalities, an electrocardiogram (ECG) monitoring should be performed periodically (every 2 years or more frequently, if considered necessary);
Danish: • Under behandlingen med Namuscla: o monitorering med elektrokardiogram (ekg) skal foretages regelmæssigt (hvert andet år eller oftere, hvis det skønnes nødvendigt) hos patienter uden hjerteabnormaliteter; o hos patienter med hjerteabnormaliteter eller med en tilbøjelighed til dette skal en detaljeret vurdering af hjertefunktionen (inklusive ekg) foretages før og efter en øgning i dosen.
English: - liver problems - kidney problems - low or high potassium blood levels - low magnesium blood levels - epilepsy
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Namuscla, hvis du har: - problemer med hjertet - problemer med leveren - problemer med nyrerne - lavt eller højt kaliumniveau i blodet - lavt magnesiumniveau i blodet - epilepsi
English: CYP1A2 & CYP2D6 inducers
Danish: CYP1A2- og CYP2D6-inducerende stoffer
English: • Inform patients that, before starting and throughout treatment with Namuscla, HCPs should perform a detailed and careful cardiac evaluation;
Danish: • informere patienter om, at det sundhedsfaglige personale skal foretage en detaljeret og omhyggelig undersøgelse af hjertet inden påbegyndelse af behandlingen og løbende under behandlingen;
English: In case of modification of the mexiletine dose, or if medicinal products susceptible to affect cardiac conduction are co-administered with mexiletine, patients should be closely monitored by ECG (especially patients with conduction anomalies) (see sections 4.3 and 4.4).
Danish: Patienter (særligt patienter med ledningsforstyrrelser) skal nøje monitoreres med ekg, hvis dosen af mexiletin ændres eller ved samtidig administration af mexiletin med lægemidler, der er tilbøjelige til at påvirke hjerteledning (se pkt.
English: Not known: diarrhoea, vomiting, oesophageal ulcers and perforation Hepatobiliary disorders
Danish: Ikke kendt: diarré, opkastning, sår i og perforering af spiserøret Lever og galdeveje
English: General disorders and administration site conditions Common: fatigue, asthenia, chest discomfort, malaise
Danish: Knogler, led, muskler og bindevæv Almindelig: smerter i ekstremiteter Almene symptomer og reaktioner på administrationsstedet Almindelig: træthed, asteni, ubehag i brystet, utilpashed
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Namuscla Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Before starting mexiletine treatment, detailed and careful cardiac evaluation should be carried out; throughout treatment with mexiletine, cardiac monitoring needs to be continued and adapted as a function of the heart condition of the patient (see contraindications in section 4.3 and warning in section 4.4).
Danish: I hele forløbet med mexiletin skal patientens hjerte monitoreres i henhold til patientens hjertetilstand (se kontraindikationer i pkt.
English: Marketing Authorisation Holder Lupin Europe GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main Germany
Danish: Indehaver af markedsføringstilladelsen Lupin Europe GmbH Hanauer Landstraße 139-143
English: + Species for which high-resistance rates (more than 50%) have been observed in one or more areas/countries/regions within the EU.
Danish: Arter, for hvilke der er observeret høje resistensrater (mere end 50 %) i ét eller flere områder/lande/regioner inden for EU.
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Danish: Efter kommissionens afgørelse opdatere den kompetente myndighed i medlemslandet i samarbejde med referencemedlemslandet produktinformationen som påkrævet.
English: Every 6 hours
Danish: Hver 6. time
English: The direct Coombs test may be positive.
Danish: Den direkte Coombs-test kan være positiv.
English: No data from controlled clinical studies are available.
Danish: Der foreligger ingen data fra kontrollerede kliniske undersøgelser.
English: if you have low levels of potassium in your blood.
Danish: hvis du har et lavt kaliumniveau i blodet.
English: The usual duration of treatment for most indications is in the range of 5-14 days.
Danish: Den sædvanlige behandlingsvarighed for de fleste indikationer er 5-14 dage.
English: Paediatric population (2-12 years of age)
Danish: Pædiatrisk population (2-12 år)
English: From a microbiological point of view, the reconstituted and diluted solutions should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør den rekonstituerede og fortyndede opløsning anvendes med det samme.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen den nævnte måned.
English: Tazocin (recommended dose)
Danish: Tazocin (anbefalet dosis)
English: As you will receive TAZOCIN from a doctor or other healthcare professional, you are unlikely to be given the wrong dose.
Danish: Da TAZOCIN vil blive indgivet af en læge eller en anden sundhedsfaglig person, er det usandsynligt, at du får en forkert dosis.
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Dette produktresumé, mærkningen og indlægssedlen repræsenterer derfor ikke nødvendigvis den nugældende tekst.
English: The majority of those events experienced, including nausea, vomiting, and diarrhoea, have also been reported with the usual recommended dose.
Danish: Størstedelen af disse hændelser, herunder kvalme, opkastning og diarré, er også blevet rapporteret med den sædvanlige anbefalede dosis.
English: * Compatible solvents for reconstitution:
Danish: * Forligelige solvenser til rekonstituering:
English: Maximum recommended volume of sterile water for injection per dose is 50 ml.
Danish: Den anbefalede maksimale mængde sterilt vand til injektion pr. dosis er 50 ml.
English: Tell the doctor or laboratory staff that you are taking TAZOCIN if you have to provide a blood or urine sample.
Danish: Fortæl til lægen eller laboratoriepersonalet, at du tager TAZOCIN, hvis du skal aflevere en blod- eller urinprøve.
English: The dose of medicine given to you depends on what you are being treated for, your age, and whether or not you have kidney problems.
Danish: Den dosis lægemiddel, du får, afhænger af, hvad du alder, og om du har nyreproblemer eller ej.
English: This difference may be due to age-related changes in creatinine clearance.
Danish: Denne forskel kan skyldes aldersrelaterede kreatininclearance.
English: medicines used to relax your muscles during surgery.
Danish: dine muskler til at slappe af under operation.
English: Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and genotoxicity.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af toksicitet efter gentagne doser og genotoksicitet.
English: White to off-white powder.
Danish: idt til offwhite pulver.
English: Positive test results for the assays listed above in patients receiving Tazocin should be confirmed by other diagnostic methods.
Danish: Positive testresultater for ovennævnte prøver hos patienter i behandling med Tazocin bør bekræftes ved hjælp af andre diagnostiske metoder.
English: However, the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.
Danish: Behandlingsvarigheden bør dog bestemmes ud fra infektionens sværhedsgrad, patogenet(patogenerne) og patientens kliniske og bakteriologiske fremskridt.
English: Like all medicines, TAZOCIN can cause side effects, although not everybody gets them.
Danish: TAZOCIN kan som al anden medicin give bivirkninger, men ikke alle får bivi rkninger.
English: You will be given TAZOCIN until the sign of infection has gone completely (5 to 14 days).
Danish: Du vil blive behandlet med TAZOCIN, indtil tegnet på infektion er helt forsvundet (5-14 dage Patienter med nyreproblemer
English: Piperacillin and tazobactam cross the placenta.
Danish: Piperacillin og tazobactam passerer placenta.
English: Take special care with TAZOCIN if you have allergies.
Danish: r ekstra forsigtig med at bruge TAZOCIN hvis du har allergier.
English: Piperacillin and tazobactam can pass to a baby in the womb or through breast milk.
Danish: Piperacillin og tazobactam kan overføres til en baby i livmoderen eller gennem modermælken.
English: Bio-Rad Laboratories Platelia Aspergillus EIA tests may lead to false-positive results for patients receiving Tazocin.
Danish: Bio-Rad Laboratories' Platelia Aspergillus-EIA-test kan føre til falsk-positive resultater for patienter, der er i behandling med Tazocin.
English: Effects on laboratory tests
Danish: Indvirkning på laboratorieprøver
English: Group B streptococci
Danish: Gruppe B-streptococci
English: Additionally, alterations in bacterial membrane permeability, as well as expression of multi-drug efflux pumps, may cause or contribute to bacterial resistance to piperacillin / tazobactam, especially in Gram-negative bacteria.
Danish: Derudover kan ændringer i bakteriel membranpermeabilitet samt ekspression af flerstofseffluxpumper medføre eller bidrage til bakteriel resistens over for piperacillin / tazobactam, især ved gramnegative bakterier.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Danish: Bemærk: Dette produktresumé, mærkningen og indlægssedlen er den gyldige ve for kommissionens afgørelse.
English: Mean tissue concentrations are generally 50 to 100% of those in plasma.
Danish: Den gennemsnitlige koncentration i væv er generelt 50-100 % af plasmakoncentrationen.
English: Do not take any medicine for the diarrhoea without first checking with your doctor.
Danish: Bru medicin mod diarré uden først at have talt med din læge.
English: These include: medicine for gout (probenecid).
Danish: Disse omfatter: lægemidler mod urinsyregigt (probenecid).
English: Women who are breast-feeding should be treated only if the expected benefit outweighs the possible risks to the woman and child.
Danish: Kvinder, der ammer, bør kun behandles, hvis den forventede opvejer de mulige risici for barnet.
English: Both piperacillin and tazobactam are approximately 30% bound to plasma proteins.
Danish: Både piperacillin og tazobactam bindes for ca. 30 procents vedkommende til plasmaproteiner.
English: • Alteration of penicillin-binding proteins (PBPs), which results in the reduction of the affinity of piperacillin for the molecular target in bacteria.
Danish: • Ændring af penicillinbindende proteiner, hvilket medfører reduktion af piperacillins affinitet over for det molekylære mål i bakterier.
English: No difference in piperacillin or tazobactam pharmacokinetics was observed between Asian (n=9) and Caucasian (n=9) healthy volunteers who received single 4 g / 0.5 g doses.
Danish: Der blev ikke observeret nogen forskel i piperacillins og tazobactams farmakokinetik mellem asiatiske (n = 9) og kaukasiske (n = 9) raske frivillige forsøgspersoner, der fik en enkelt 4 g/0,5 g-dosis.
English: Treatment should be supportive and symptomatic according to the patient's clinical presentation.
Danish: Behandling bør være understøttende og symptomatisk i overensstemmelse me præsentation.
English: Pack sizes: 1, 5, 10, 12 or 25 vials per carton.
Danish: Pakningsstørrelser: 1, 5, 10, 12 eller 25 hætteglas pr. æske.
English: Do not use TAZOCIN if you are allergic (hypersensitive) to piperacillin or tazobactam or any of the other ingredients of TAZOCIN.
Danish: Brug ikke TAZOCIN hvis du er overfølsom (allergisk) over for piperacillin eller tazobactam eller et af de øvrige indholdsstoffer i TAZOCIN.
English: However, if you experience side effects, such as convulsions, or think you have been given too much, tell your doctor immediately.
Danish: Hvis du alligevel oplever bivirkninger såsom kramper, eller hvis du tror, at du har fået for meget, skal du straks informere din læge.
English: If you think you have not been given a dose of TAZOCIN, tell your doctor or other healthcare professional immediately.
Danish: Hvis du tror, at du ikke har fået en dosis TAZOCIN, skal du straks sige det til din læge eller en anden sundhedsfaglig person.
English: The two main mechanisms of resistance to piperacillin / tazobactam are:
Danish: De to vigtigste mekanismer, der giver resistens over for piperacillin / tazobactam, er:
English: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vecuronium.
Danish: Piperacillin har ved samtidig brug af vecuronium været medvirkende til forlængelse af vecuroniums neuromuskulære blokade.
English: Volume of solvent* to be added to vial
Danish: Mængde af solvens*, der skal tilsættes
English: For reconstitution instructions, see section 6.6.
Danish: Se oplysningerne vedrø og 6.6.
English: Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure).
Danish: Patienterne kan opleve neuromuskulær irritabilitet eller kramper, hvis der gives højere intravenøse doser end anbefalet (især ved tilstedeværelse af nyresvigt).
English: Your doctor will decide if TAZOCIN is right for you.
Danish: Din læge vil beslutte, om TAZOCIN er godt for dig.