FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose for adults is one 400 mg film-coated tablet once daily.
Danish: Den normale dosis for voksne er én 400 mg tablet dagligt.
English: - If you are elderly with existing kidney problems take care that your fluid intake is sufficient because dehydration may increase the risk of kidney failure.
Danish: - Hvis De er ældre og har nyreproblemer, skal De sørge for at indtage tilstrækkelig væske, da dehydrering kan øge risikoen for nyresvigt.
English: No adjustment of the dose is required in elderly patients, patients with a low bodyweight or in patients with kidney problems.
Danish: Det er ikke nødvendigt at justere doseringen hos ældre patienter, patienter med lav kropsvægt eller hos patienter med nedsat nyrefunktion.
English: Pharmacodynamic investigations have demonstrated that moxifloxacin exhibits a concentration dependent killing rate.
Danish: Farmakodynamiske undersøgelser har vist, at moxifloxacin har en koncentrationsafhængig drabshastighed.
English: Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
Danish: Effekt og sikkerhed ved brug af moxifloxacin til børn og unge er ikke undersøgt (se pkt.
English: - Pregnancy and lactation (see section 4.6).
Danish: - Graviditet og amning (se pkt.
English: Please contact your doctor before you continue the treatment if you develop signs such as rapidly feeling unwell and/or being sick associated with yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or liver induced disease of the brain (symptoms of a reduced liver function or a rapid and severe inflammation of the liver).
Danish: Kontakt Deres læge, før De fortsætter behandlingen, hvis De opdager tegn på hurtig tiltagende utilpashed og/eller føler Dem syg i forbindelse med gulfarvning af det hvide i øjnene, mørk urin, kløe i huden, tendens til at bløde eller leverrelateret hjernesygdom (symptomer på nedsat leverfunktion eller en hurtigt indsættende og alvorlig betændelse i leveren).
English: Use should be with caution in patients with CNS disorders which may predispose to seizures or lower the seizure threshold.
Danish: Præparatet bør anvendes med forsigtighed til patienter med CNS-forstyrrelser, som kan give krampeanfald eller nedsætte krampetærsklen.
English: At the first sign of any pain or inflammation you should stop taking [Invented name], rest the affected limb and consult your doctor immediately.
Danish: Ved det første tegn på smerte eller betændelse, skal De stoppe med at tage [Lægemidlets navn], hvile det angrebne ben og kontakte lægen straks.
English: The analysis of the incidence of cardiac adverse events did not reveal any special subgroups of PID patients for whom moxifloxacin presents a greater risk than comparator treatments.
Danish: Ud fra analysen af forekomsten af uønskede hjertehændelser kunne det ikke påvises, om nogen særlig undergruppe af PID-patienter har større risiko i forbindelse med behandling med moxifloxacin i forhold til behandling med sammenligningspræparater.
English: - If you were born with or have had any condition with certain abnormal electrocardiogram (ECG, electrical recording of the heart) changes, have salt imbalance in the blood, especially low concentrations of potassium in the blood (hypokalaemia) which are currently not corrected by treatment, have a very slow heart rate (bradycardia), have a weak heart (heart failure), have a history of abnormal heart rhythms (arrhythmias), or you are taking other medicines that result in certain abnormal ECG changes (see section Taking other medicines).
Danish: - hvis De har medfødt eller kendt afvigende hjertekardiogram (EKG, elektrisk måling af hjertet), har ubalance i blodets salte, specielt lavt kaliumindhold i blodet (hypokaliæmi), der ikke korrigeres for med behandling på nuværende tidspunkt, har en meget langsom hjertefrekvens (bradykardi), har et svagt hjerte (hjertesvigt), har tidligere haft uregelmæssig hjerterytme (arytmi) eller tager anden medicin, der medfører unormale EKG-ændringer (se pkt.
English: The following peak concentrations (geometric mean) were observed following administration of a single oral dose of 400 mg moxifloxacin:
Danish: Følgende maksimale koncentrationer (geometrisk middelværdi) af moxifloxacin blev fundet efter en enkelt oral dosis på 400 mg:
English: It became evident during the course of the variation preceding this referral that an empirical therapy of PID with moxifloxacin should be avoided due to the high portion of N. gonorrhoeae being resistant to moxifloxacin and other quinolones.
Danish: I løbet af ændringsproceduren forud for denne indbringelse blev det klart, at empirisk behandling af PID med moxifloxacin skulle undgås på grund af den høje forekomst af N. gonorrhoeae-resistens over for moxifloxacin og andre quinoloner.
English: Important information about some of the ingredients of [Invented name] 400 mg film-coated tablets [Invented name] tablets contain lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i [Lægemidlets navn] [Lægemidlets navn]-tabletter indeholder lactose.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG INDLÆGSSEDDEL
English: Objections and concerns over the efficacy and safety of Avalox in the proposed indication were raised during the Mutual Recognition variation procedure.
Danish: I løbet af den gensidige anerkendelsesprocedure vedrørende ændringen blev der rejst indsigelser og betænkeligheder vedrørende effekten og sikkerheden ved Avalox i forbindelse med den ansøgte indikation.
English: Consult your doctor if you wish to stop taking your tablets before the end of the course of treatment.
Danish: Kontakt lægen, hvis De ønsker at stoppe behandlingen før tid.
English: - If you suffer from epilepsy or a condition which makes you likely to have convulsions, consult your doctor before taking [Invented name].
Danish: - Hvis De lider af epilepsi eller en tilstand, hvor De ofte får kramper, skal De kontakte lægen, inden De begynder at tage [Lægemidlets navn].
English: - Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with moxifloxacin (see section 4.8).
Danish: - Tilfælde af fulminant hepatitis, som potentielt kan føre til livstruende leverinsufficiens, er blevet indberettet ved brug af moxifloxacin (se pkt.
English: were reduced, as were the anaerobes Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp., and Peptostreptococcus spp.. For Bacteroides fragilis there was an increase.
Danish: blev reduceret, ligesom de anaerobe Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp.
English: If you are currently taking any medicine that decrease your blood potassium levels, consult your doctor before taking [Invented name].
Danish: Hvis De tager anden medicin, der nedsætter blodets kaliumniveau, skal De kontakte lægen, inden De begynder at tage [Lægemidlets navn].
English: If you take more than the prescribed one tablet a day, seek medical advice immediately and, if possible, take any remaining tablets, the packaging or this leaflet with you to show the doctor or pharmacist what you have taken.
Danish: Hvis det er muligt, skal De tage de resterende tabletter, pakningen og denne indlægsseddel med til lægen eller apoteket for at vise, hvad De har indtaget.
English: Aerobic Gram-negative micro-organisms
Danish: Aerobe gramnegative mikroorganismer
English: Streptococcus Groups A, B, C, G
Danish: Streptococcus gruppe A,B,C,G ≤ 0.5 mg/l
English: Moraxella (Branhamella) catarrhalis* Anaerobic micro-organisms
Danish: Moraxella (Branhamella) catarrhalis*
English: IE - Ireland
Danish: IR - Irland
English: PL - Poland
Danish: PL Polen
English: Therefore, do not take [Invented name] together with the following medicines: Medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
Danish: amiodaron, sotalol, dofetilid, ibutilid), neuroleptika (f.eks phentiaziner, pimozid, sertindol, haloperidol, sultoprid), tricykliske antidepressiva, visse antimikrobe midler (f.eks. sparfloxacin, intravenøs erythromycin, pentamidin, malariamidler især halofantrin), visse antihistaminer (f.eks. terfenadin, astemizol, mizolastin), og anden medicin (f.eks. cisaprid, intravenøs vinkamin, bepridil og difemanil).
English: - If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform your doctor, who will advise whether [Invented name] is suitable for you.
Danish: - Hvis De eller nogen i Deres familie har glucose-6-phosphat-dehydrogenase-mangel (en sjælden arvelig sygdom), skal De informere lægen, der vil fortælle, om [Lægemidlets navn] er velegnet til Dem.
English: For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances, particularly in uncorrected hypokalaemia - Clinically relevant bradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrhythmias Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Danish: Af sikkerhedshensyn er moxifloxacin derfor kontraindiceret til patienter med: - medfødt eller erkendt erhvervet QT-forlængelse - elektrolytforstyrrelser, specielt ukorrigeret hypokaliæmi - klinisk relevant bradykardi - klinisk relevant hjertesvigt med nedsat venstre ventrikulær uddrivningsfraktion - tidligere anamnese med symptomatisk arytmi Moxifloxacin bør ikke bruges samtidig med andre lægemidler som forlænger QT-intervallet (se pkt.
English: At the first sign of pain or inflammation, patients should discontinue treatment with moxifloxacin and rest the affected limb(s).
Danish: Ved de første tegn på smerte eller inflammation, skal behandlingen med moxifloxacin afbrydes og den berørte ekstremitet skal aflastes.
English: If you forget to take [Invented name] 400 mg film-coated tablets If you forget to take your tablet you should take it as soon as you remember on the same day.
Danish: Hvis De glemmer at tage Deres tablet, skal De tage den så snart De husker det samme dag.
English: Therefore in such cases empirical moxifloxacin should be co-administered with another appropriate antibiotic (e.g. a cephalosporin) unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded.
Danish: I sådanne tilfælde skal empirisk moxifloxacin derfor gives sammen med et andet passende antiboitikum (f.eks. cephalosporin), med mindre moxifloxacin-resistent Neisseria gonorrhoeae kan udelukkes.
English: Do not take [Invented name] 400 mg film-coated tablets - If you are allergic (hypersensitive) to the active ingredient moxifloxacin, any other quinolone antibiotics or any of the other ingredients (see section 6.
Danish: Tag ikke [Lægemidlets navn] - hvis De er overfølsom (allergisk) over for moxifloxacin, andre quinolon-antibiotika, eller et af de øvrige indholdsstoffer.
English: - The Committee considered that robust data is available showing the efficacy of Avalox in the indication “Treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” , however due to emerging resistance of N. gonorrhoeae, moxifloxacin should not be used in empirical monotherapy, unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Danish: - Udvalget var af den opfattelse, at der eksisterer fyldestgørende data for virkningen af Avalox i forbindelse med indikationen "Behandling af let til moderat PID (pelvic inflammatory disease), dvs. infektioner i de øvre genitaler, herunder salpingitis og endometritis", dog må moxifloxacin på grund af fremkomsten af resistens over for N. gonorrhoeae ikke anvendes i empirisk monoterapi, medmindre moxifloxacin-resistent N. gonorrhoeae kan udelukkes.
English: It is approved for the treatment of the following bacterial infections if they are caused by bacteria susceptible to moxifloxacin: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed).
Danish: Det er godkendt til behandling af følgende bakterielle infektioner, hvis de er forårsaget af moxifloxacin-følsomme bakterier: - Akut forværring af kronisk bronkitis - Samfundserhvervet pneumoni, med undtagelse af svære tilfælde - Akut bakteriel sinusitis (adækvat diagnosticeret).
English: In the analysis of ECGs obtained in the clinical trial program, QTc prolongation with moxifloxacin was 6 msec ± 26 msec, 1.4% compared to baseline.
Danish: Ved analyse af EKG'er fra det kliniske undersøgelsesprogram var forlængelsen af QTc med moxifloxacin 6 msek.
English: No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).
Danish: Det er ikke nødvendigt at justere dosis til patienter med let til svær nedsat nyrefunktion eller til patienter i kronisk dialyse, dvs. hæmodialyse og vedvarende ambulatorisk peritonealdialyse (se pkt.
English: [Invented name] tablets are not sufficient for sole therapy of this kind of infections and therefore another antibiotic in addition to [Invented name] tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract (see section 2.
Danish: Det er ikke tilstrækkeligt at behandle disse typer betændelsestilstande kun med [Lægemidlets navn]-tabletter, og din læge skal ordinere yderligere et antibiotikum udover [Lægemidlets navn]-tabletter til behandling af betændelsestilstande i de øvre dele af kvindens underliv (se pkt.
English: - If you have a history of tendon disease or disorder which was related to treatment with quinolone antibiotics (see sections Take special care ... and 4.
Danish: - hvis De tidligere har haft sygdomme i senerne eller sygdomme, der var relateret til behandling med quinolonantibiotika (se pkt.
English: #ESBL-producing strains are commonly resistant to fluoroquinolones +Resistance rate > 50% in one or more countries
Danish: +Resistenshyppighed > 50 % i et eller flere lande.
English: The CHMP considered that due to the emergence of fluoroquinolone-resistant N. gonorrhoeae strains moxifloxacin should not be used in empirical monotherapy of mild to moderate PID, unless a resistance against moxifloxacin can be ruled out.
Danish: CHMP var af den opfattelse, at moxifloxacin på grund af fremkomsten af fluoroquinolon-resistente N. gonorrhoeae-stammer ikke bør anvendes i empirisk monoterapi i forbindelse med let til moderat PID, medmindre moxifloxacin-resistens kan udelukkes.
English: As renal function decreases,
Danish: Nedsat nyre- og leverfunktion
English: In clinical practice, this would mean that moxifloxacin should be used in combination with an approved agent active against fluoroquinolone resistant N. gonorrhoeae (e.g. a cephalosporin) for empirical treatment of PID unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Danish: I klinisk praksis vil dette betyde, at moxifloxacin skal bruges i kombination med et godkendt stof, der er aktivt imod fluoroquinolon-resistente N. gonorrhoeae-stammer (f.eks. cephalosporin) i forbindelse med empirisk behandling af PID, medmindre moxifloxacin-resistente N. gonorrhoeae-stammer kan udelukkes.
English: When taking [Invented name] 400 mg film-coated tablets - The risk of cardiac abnormalities may increase with increase of the dose.
Danish: Når De tager [Lægemidlets navn] - Risikoen for hjerteforstyrrelser kan øges ved øget dosis.
English: Driving and using machines [Invented name] may make you feel dizzy or light-headed.
Danish: Trafik- og arbejdssikkerhed [Lægemidlets navn] kan medføre svimmelhed eller uklarhed.
English: - There is a rare chance that you may experience a severe, sudden allergic reaction (an anaphylactic reaction/shock) even with the first dose, with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing.
Danish: - Der er en sjælden risiko for at De vil opleve en alvorlig, pludselig allergisk reaktion (en anafylaktisk reaktion/chok) selv ved den første dosis.
English: If so, stop taking [Invented name] and seek medical advice immediately.
Danish: Hvis De oplever ovenstående, skal De stoppe med at tage [Lægemidlets navn] og kontakte lægen straks.
English: Information and recommendations regarding taking measures before prescribing moxifloxacin are adequately addressed in the ‘contraindications' and ‘warnings-precaution of use' sections of the SPC and PL.
Danish: Afsnittene "Kontraindikationer" og "Særlige advarsler og forsigtighedsregler vedrørende brugen" i produktresuméet og i produktinformationen indeholder tilstrækkelige oplysninger om og anbefalinger for, hvilke forholdsregler der skal tages inden ordinering af moxifloxacin.
English: [Invented name] 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.
Danish: I kliniske studier har man undersøgt behandling med [Lægemidlets navn] 400 mg filmovertrukne tabletter i op til 14 dage.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive micro-organisms Staphylococcus aureus (methicillin-resistant)+
Danish: Arter, hvor erhvervet resistens kan være et problem Aerobe grampositive mikroorganismer
English: IZILOX 400 mg, comprimé pelliculé 400 mg
Danish: IZILOX 400 mg, compromé pelliculé
English: For [Invented name] be aware of the following: - If you are taking [Invented name] and other medicines that affect your heart there is an increased risk for altering your heartbeat.
Danish: Dette gælder også medicin, som ikke er købt på recept.Vær opmærksom på følgende med [Lægemidlets navn]: - Hvis De anvender [Lægemidlets navn] samtidigt med anden medicin, som påvirker hjertet, er der en øget risiko for ændringer i hjerterytmen.
English: Therefore, you should adhere to the dosage.
Danish: De skal derfor altid følge lægens anvisning.
English: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Danish: 2794-003 Carnaxide Portugal
English: If you experience palpitations or irregular heart beat during the period of treatment, you should inform your doctor immediately.
Danish: Hvis De får hjertebanken eller uregelmæssige hjerteslag under behandlingen, skal De straks kontakte lægen, som muligvis vil tage et EKG for at undersøge Deres hjerterytme.
English: [Invented name] 400 mg film-coated tablets are indicated for the treatment of the above infections if they are caused by bacteria susceptible to moxifloxacin.
Danish: [Lægemidlets navn] anvendes til behandling af ovennævnte infektioner, hvis de er forårsaget af moxifloxacin følsomme bakterier.
English: If you stop taking [Invented name] 400 mg film-coated tablets If you stop taking this medicine too soon your infection may not be completely cured.
Danish: Hvis De holder op med at tage [Lægemidlets navn] Hvis De stopper behandlingen for tidligt, helbredes betændelsestilstanden måske ikke helt.
English: - The Committee, in view of the presented data on efficacy and safety, considered that the Benefit / Risk balance for Avalox and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable; - The CHMP, as a consequence, recommended the amendment of the Summary of Product Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Avalox and associated names (see Annex I).
Danish: - CHMP anbefalede derfor, at der for Avalox og tilknyttede navne (se bilag I) foretages ændring af afsnit 4.1, 4.2, 4.3, 4.4, 5.1 og 5.2 i produktresuméet samt relevante afsnit af indlægssedlen som beskrevet i bilag III.
English: [Invented name] is used in adults for treating the following bacterial infections: - Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) - Infection of the lungs (pneumonia) acquired outside the hospital, except severe cases - Acute infection of the sinuses (acute bacterial sinusitis) - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane.
Danish: [Lægemidlets navn] anvendes til behandling af voksne med følgende bakterielle infektioner, hvis der kræves en behandlingen uden om tarmsystemet: - Pludselig forværring af kronisk bronkitis - Lungebetændelse, som man har fået uden for hospitalet, med undtagelse af alvorlige tilfælde - Akut bihulebetændelse (akut bakteriel sinusitis) - Mild til moderat betændelse i de øvre dele af kvindens underliv (bækkenbetændelse), herunder betændelse i æggelederne og i livmoderens slimhinder.
English: [Invented name] 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded (see sections 4.4 and 5.1).
Danish: [Lægemidlets navn] bør ikke anvendes til monoterapi af mild til moderat bækkenbetændelse, men skal anvendes i kombination med et andet passende antibakterielt middel (f.eks. cephalosporin) på grund af en øget moxifloxacin-resistens i forhold til Neisseria gonorrhoeae, med mindre moxifloxacin-resistent Neisseria gonorrhoeae kan udelukkes (se pkt.
English: [Invented name] 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed) - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Danish: [Lægemidlets navn] anvendes til behandling af følgende bakterielle infektioner: - Akut forværring af kronisk bronkitis - Ikke hospitalserhvervet lungebetændelse, med undtagelse af svære tilfælde - Akut bakteriel sinuitis (adækvat diagnosticeret) - Mild til moderat bækkenbetændelse (dvs. infektioner i de øvre genitialier hos kvinder, herunder salpingitis og endometritis, uden en ledsagende abscess i æggestokkene eller bækkenet.
English: Therefore, take your [Invented name] tablet 6 hours before or after taking the other medicine.
Danish: Tag derfor [Lægemidlets navn]-tabletter 6 timer før eller efter indtagelsen af anden medicin.
English: BE - Belgium Bayer s.a.-n.v. Avenue Louise 143
Danish: LU - Luxemburg Bayer s.a.-n.v.
English: - If you have a complicated infection of the female upper genital tract (e.g. associated with an abscess of the fallopian tubes and ovaries or of the pelvis), for which your doctor considers an intravenous treatment necessary, treatment with [Invented name] tablets is not appropriate.
Danish: - [Lægemidlets navn] må ikke anvendes, hvis De har en kompliceret betændelse i den øvre del af underlivet (f.eks. i forbindelse med en byld i æggelederne og æggestokken eller i bækkenet, hvor Deres læge skønner, at behandling via indsprøjtning er nødvendig.