FrancophonIA/ELRC3.0 huggingface dataset:
English: [INN] should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.
Danish: [INN] skal omgående seponeres ved de første tegn eller symptomer på en alvorlig bivirkning, og patienterne skal rådes til at kontakte deres ordinerende læge for rådgivning.
English: The following new wording should be included after listing of side effects:
Danish: Den følgende nye ordlyd skal inkluderes efter listen med bivirkninger:
English: Tuberculosis, in combination treatment
Danish: • Tuberkulose, i kombinationsbehandling
English: Annex III Amendments to relevant sections of the product information
Danish: Bilag III Ændringer af relevante punkter i produktinformationen
English: At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with [INN] should be discontinued and alternative treatment should be considered.
Danish: Ved det første tegn på tendinitis (f.eks. smertefuld hævelse,inflammation) skal behandlingen med [INN] seponeres, og der skal overvejes alternativ behandling.
English: The affected limb(s) should be appropriately treated (e.g. immobilisation).
Danish: Det/de påvirkede lem(mer) skal behandles på passende vis (f.eks. immobilisering).
English: Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of <product name> therapy.
Danish: Der kan opstå betændelse og bristning af sener i løbet af de første 48 timers behandling, og endda op til flere måneder, efter du er stoppet behandlingen med <præparatnavn>.
English: The warning about peripheral neuropathies should be included/amended as follows:
Danish: Advarslen om perifere neuropatier skal inkluderes/ændres på følgende måde:
English: Endocarditis
Danish: Endokarditis
English: The current warning statement on tendinopathies/tendon disorders should be amended with regard to risk factors, time to onset and need for monitoring of patients and should include at least the following information (or added as new statement if missing):
Danish: Den aktuelle advarsel om tendinopatier/senebesvær skal ændres med hensyn til risikofaktorer, tid til start og behov for at overvåge patienter, og mindst omfatte de følgende oplysninger (eller tilføjes som en ny advarsel hvis den mangler):
English: At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking <product name>, contact your doctor and rest the painful area.
Danish: Ved det første tegn på smerter eller betændelse i en sene (for eksempel i din ankel, håndled, albue, skulder eller knæ), skal du holde op med at tage <præparatnavn>, kontakte lægen og hvile det smertefulde område.
English: The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids.
Danish: Risikoen for tendinitis og seneruptur er øget hos ældre patienter, patienter med nedsat nyrefunktion, patienter med transplantation af solide organer og patienter, der samtidigt behandles med kortikosteroider.
English: General disorders and administrative site conditions* Psychiatric disorders*
Danish: Almene symptomer og reaktioner på administrationsstedet* Psykiske forstyrrelser*
English: Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
Danish: Tendinitis og seneruptur (især, men ikke begrænset til akillessenen), nogle gange bilateralt, kan forekomme så tidligt som indenfor 48 timer efter behandlingsstart med quinoloner og fluoroquinoloner, og der er blevet rapporteret forekomster selv op til flere måneder efter seponering af behandlingen.
English: Ear and labyrinth disorders*
Danish: Øre og labyrint*
English: • Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection
Danish: • Ciprofloxacin kan anvendes til behandling af neutropene patienter med feber, som formodes at skyldes en bakterieinfektion
English: Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely.
Danish: Smerter og hævelse af led og betændelse eller bristning af sener kan forekomme i sjældne tilfælde.
English: Additionally for the active substance stated below, the following indications should also be deleted: Pefloxacin
Danish: Desuden skal de følgende indikationer også slettes, for det nedenfor angivne aktive stof: Pefloxacin
English: The following warning should be included:
Danish: Den følgende advarsel skal inkluderes:
English: • Infection in immunocompromised patients
Danish: • Infektion hos immunkompromitterede patienter
English: • Post-exposure prophylaxis and curative treatment of anthrax.
Danish: • Profylakse efter eksponering og kurativ behandling af anthrax.
English: • Acute and chronic prostatitis, including severe forms
Danish: • Akut og kronisk prostatitis, herunder svære former
English: Section 4.8: undesirable effects
Danish: 4.8: Bivirkninger
English: Patients under treatment with [INN] should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition.
Danish: Patienter i behandling med [INN] skal instrueres i at kontakte deres læge, før de fortsætter behandlingen, hvis de udvikler symptomer på neuropati, som f.eks. smerter, en brændende eller prikkende fornemmelse, følelsesløshed eller svaghed for at forebygge udviklingen af en potentielt irreversibel tilstand (se pkt.
English: You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms.
Danish: Du kan i sjældne tilfælde opleve symptomer på nervebeskadigelse (neuropati), såsom smerter, brændende fornemmelse, prikken, følelsesløshed og/eller svaghed, især i fødder og ben eller i hænder og arme.
English: • Bronchial suppurations, in the absence of any parenchymal lesion: In subjects at risk (chronic alcoholism, smoking, subjects over 65 years)
Danish: • Bronkialt pus, når der ikke er nogen parenkyme læsioner til stede: Hos personer i risikogruppen (kronisk alkoholisme, rygning, personer over 65 år)
English: • Immunocompromised patients: o Infections in neutropenic patients (as prophylaxis).
Danish: • Immunkompromitterede patienter: o Infektioner hos neutropene patienter (som profylakse).
English: You should not take fluoroquinolone/quinolone antibacterial medicines, including [product name], if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Danish: Du må ikke tage antibakterielle lægemidler med fluoroquinolon/quinolon, herunder [præparatnavn], hvis du tidligere har oplevet alvorlige bivirkninger, når du har taget quinolon eller fluoroquinolon.
English: External otitis
Danish: Ekstern otitis
English: • Complicated intra-abdominal infections.
Danish: • Komplicerede intra-abdominale infektioner.
English: • Sepsis due to above-mentioned genito-urinary infections
Danish: • Sepsis på grund af de ovenfor nævnte urogenitale infektioner
English: These infections include cystitis,
Danish: Disse infektioner omfatter cystitis, pyelitis,
English: Additionally for the following active substances, the following indications should be amended as recommended below:
Danish: Desuden skal de følgende indikationer ændres i henhold til nedenstående anbefalinger, for de følgende aktive stoffer:
English: The following new warning should be included:
Danish: Den følgende nye advarsel skal inkluderes:
English: • Acute sinusitis (last line)
Danish: • Akut sinuitis (sidste linje)
English: • Malignant external otitis
Danish: • Malign ekstern otitis
English: • Superinfection of chronic otitis (whatever its nature) and cavities after mastodectomy
Danish: • Superinfektion ved kronisk otitis (uanset art) og hulrum efter mastodektomi
English: Infection of cerebrospinal fluid
Danish: Infektion i cerebrospinalvæsken
English: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.
Danish: Tilfælde af sensorisk eller sensomotorisk polyneuropati, der medførte paræstesi, hypoæstesi, dysæstesi eller svaghed, er blevet rapporteret hos patienter, der fik quinoloner og fluoroquinoloner.
English: Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines, including [product name], have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible.
Danish: Langvarige, invaliderende og muligvis varige alvorlige bivirkninger Antibakterielle lægemidler med fluoroquinolon/quinolon, herunder [præparatnavn], er blevet forbundet med meget sjældne men alvorlige bivirkninger, hvoraf nogle af dem er langvarige (fortsætter i måneder eller år), invaliderende eller muligvis varige.
English: Recommended wording • Complicated acute cystitis
Danish: Anbefalet ordlyd • Kompliceret akut cystitis
English: The use of [INN] should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8).
Danish: Anvendelsen af [INN] bør undgås hos patienter, der tidligere har oplevet alvorlige bivirkninger, når de brugte præparater, der indeholdt quinolon eller fluoroquinolon (se pkt.
English: Uncomplicated cystitis
Danish: Ukompliceret cystitis
English: Prevention of infection in surgical procedures
Danish: Forebyggelse af infektion ved kirurgiske indgreb
English: In addition of the amendments recommended below, the following sentence should be included in all quinolones and fluoroquinolones containing medicinal products at the end of section 4.1:
Danish: Udover de nedenfor anbefalede ændringer, skal den følgende sætning inkluderes for alle lægemidler, der indeholder quinoloner og fluoroquinoloner, sidst i pkt.
English: The indications in the table below should be deleted for all quinolones/ fluoroquinolones containing products Pharyngitis-Tonsillitis
Danish: Indikationerne i den nedenstående tabel skal slettes for alle lægemidler, der indeholder quinoloner/fluoroquinoloner Faryngitis-tonsillitis
English: • Tonsillitis Laryngitis Acute bronchitis Prophylaxis of travellers´ diarrhoea
Danish: • Tonsillitis Laryngitis Akut bronkitis Profylakse af rejsediarré
English: • Acute exacerbation of chronic bronchitis (last line)
Danish: • Akut forværring af kronisk bronkitis (sidste linje)
English: Gynaecological infections o Gynaecological infections
Danish: • Gynækologiske infektioner o Gynækologiske infektioner
English: • Inhalation anthrax: post-exposure prophylaxis and curative treatment
Danish: • Inhalationsanthrax: profylakse efter eksponering og kurativ behandling
English: • Simple uncomplicated acute cystitis in the premenopausal adult women
Danish: • Simpel, ukompliceret akut cystitis hos præmenopausale voksne kvinder
English: • Sinusitis o Sinusitis
Danish: • Sinuitis o Sinuitis
English: • Infections of bone and joints (osteomyelitis caused by gram-negative microorganisms)
Danish: • Knogle- og ledinfektioner (osteomyelitis forårsaget af gram-negative mikroorganismer)
English: • Acute uncomplicated infection of lower urinary tract (simple cystitis)
Danish: • Akut ukompliceret infektion i de nedre urinveje (simpel cystitis)
English: • Treatment of ofloxacin sensitive prophylaxis of bacterial infections in patients with weakened resistance (for example neutropenic patients)
Danish: • Behandling af ofloxacin-følsom profylakse af bakterieinfektioner hos patienter med en svækket modstandsdygtighed (for eksempel neutropene patienter)
English: • Prevention of traveller's diarrhoea Preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone Septicaemia Selective decontamination of gastrointestinal tract in patients with compromised immune system Prevention of exacerbations in women with recurring urinary tract infections
Danish: • Forebyggelse af rejsediarré Præoperative forberedelser for kronisk kolesteatomatøs otitis og kronisk otitis, der spreder sig til knoglerne Sepsis Selektiv dekontaminering i mave-tarm-kanalen hos patienter med et svækket immunsystem Forebyggelse af forværringer hos kvinder med tilbagevendende urinvejsinfektioner
English: • Perioperative prophylaxis in invasive urological surgery
Danish: • Perioperativ profylakse ved invasive urologiske operationer
English: • Pneumonia o Pneumonia, especially when caused by so-called "problematic" germs such as: E. coli, Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella or Staphylococcus o Pneumonia, above all if it's caused by bacteria such as Escherichia coli, Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella or Staphylococcus
Danish: • Pneumoni o Pneumoni, især når det forårsages af såkaldte "problematiske" bakterier, såsom: E. coli, Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella eller Staphylococcus o Pneumoni, især hvis det forårsages af bakterier, såsom Escherichia coli, Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella eller Staphylococcus
English: • Salmonella infections (carrier)
Danish: • Salmonellainfektioner (bærer)
English: • Hepato-biliary infections
Danish: • Hepatobiliære infektioner
English: • Bone and joint infections (last line) o Bone and joint infections: such as osteomyelitis or septic arthritis.
Danish: • Knogle- og ledinfektioner (sidste linje) o Knogle- og ledinfektioner, såsom osteomyelitis eller septisk artritis.
English: • Non-gonococcal urethritis and cervicitis
Danish: • Non-gonokok uretritis og cervicitis
English: • Pelvic inflammatory disease, in combination with other antibacterial agents
Danish: • PID (Pelvic Inflammatory Disease/underlivsbetændelse), i kombination med andre antibakterielle midler
English: • Pulmonary tuberculosis by resistant mycobacteria, especially in immunocompromised patients (minor anti-tuberculosis medicine)
Danish: • Lungetuberkulose fra resistente mykobakterier, især hos immunkompromitterede patienter (andenvalgsbehandling af tuberkulose)
English: • Bacterial gastroenteritis o Bacterial gastroenteritis o Bacterial enteritis o Intestinal infections o bacterial diarrhoea, which needs antibacterial treatment
Danish: • Bakteriel gastroenteritis o Bakteriel gastroenteritis o Bakteriel enteritis o Intestinale infektioner o bakteriel diarré, hvor antibakteriel behandling er nødvendig
English: • Cystitis o Cystitis o Acute and chronic cystitis in women
Danish: • Cystitis o Cystitis o Akut og kronisk cystitis hos kvinder
English: • Acute prostatitis
Danish: • Akut prostatitis
English: The indications in the table below should be restricted for all quinolones/ fluoroquinolones containing products in order to be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Danish: Indikationerne i den nedenstående tabel skal begrænses for alle præparater, der indeholder quinoloner/fluoroquinoloner, så de kun anvendes, når det ikke anses for at være hensigtsmæssigt at anvende andre antibakterielle midler, der normalt anbefales til behandling af disse infektioner.
English: • Prostatitis o prostatitis o chronic bacterial prostatitis o Acute prostatitis caused by Escherichia coli
Danish: • Prostatitis o prostatitis o kronisk bakteriel prostatitis o Akut prostatitis forårsaget af Escherichia coli
English: • Gonorrhoea o gonorrhoea o uncomplicated gonorrhea o Gonococcal urethritis, pharyngitis, proctitis or cervicitis from Neisseria gonorrhoeae irrespective of the production of penicillinase.
Danish: • Gonoré o gonoré o ukompliceret gonoré o Gonokok uretritis, faryngitis, proktitis eller cervicitis fra Neisseria gonorrhoeae, uanset produktionen af penicillinase.
English: • Alternative form of treatment for bone and joint infections
Danish: • Alternativ behandlingsform for knogle- og ledinfektioner
English: • Severe skin and soft-tissue infections (last line)
Danish: • Svære infektioner i hud og bløddele (sidste linje)
English: • Urethritis and cervicitis due to bacteria susceptible to fluoroquinolones
Danish: • Uretritis og cervicitis forårsaget af bakterier, der er følsomme over for fluoroquinoloner
English: • Uncomplicated pyelonephritis o uncomplicated pyelonephritis o acute uncomplicated pyelonephritis in women
Danish: • Ukompliceret pyelonefritis o ukompliceret pyelonefritis o akut ukompliceret pyelonefritis hos kvinder
English: • Gastroenteritis o bacterial gastroenteritis o Gastroenteritis o Acute bacterial gastroenteritis o bacterial enteritis o Acute bacterial gastroenteritis after stool culture and laboratory confirmation of the susceptibility of the causative organism to NOROCIN
Danish: • Gastroenteritis o bakteriel gastroenteritis o Gastroenteritis o Akut bakteriel gastroenteritis o bakteriel enteritis o Akut bakteriel gastroenteritis efter fæceskultur og laboratoriebekræftelse af den forårsagende organismes følsomhed over for NOROCIN
English: For quinolones and fluoroquinolones containing medicinal products, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below (new text underlined and in bold, deleted text strike through):
Danish: For lægemidler, der indeholder quinoloner og fluoroquinoloner, skal den eksisterende produktinformation ændres (indsætning, udskiftning eller sletning af tekst hvor det er relevant) for at afspejle den godkendte ordlyd nedenfor (ny tekst med understregning og fed skrift, slettet tekst med gennemstregning):
English: • Gonorrhoea • Gonococcal urethritis in humans
Danish: • Gonoré • Gonokok uretritis hos mennesker
English: • Prophylaxis after surgeries or interventions in the urogenital system o prophylaxis after surgeries or interventions in the urogenital system o Prophylaxis of recurrent urinary infections following trans-urethral surgery or trans rectal prostatic biopsy
Danish: • Profylakse efter kirurgi eller interventioner i det urogenitale system o profylakse efter kirurgi eller interventioner i det urogenitale system o Profylakse af gentagne urininfektioner efter transuretral kirurgi eller transrektal prostatabiopsi
English: An asterisk should be added to the title of selected SOCs as follows: Musculoskeletal and connective tissue disorders* Nervous system disorders*
Danish: Der skal tilføjes en stjerne til titlen af udvalgte systemorganklasser på følgende måde: Knogler, led, muskler og bindevæv*
English: • Acute urinary tract infections in men o acute urinary tract infections in men o acute infection of lower urinary tract infections in men
Danish: • Akutte urinvejsinfektioner hos mænd o akutte urinvejsinfektioner hos mænd o akutte infektioner i de nedre urinveje hos mænd
English: • Salmonella infections (carrier) • Germ carrying of salmonellosis
Danish: • Salmonellainfektioner (bærer) • Smittebærer af salmonellose
English: Nosocomial pneumonia
Danish: Hospitalserhvervet pneumoni
English: • Complicated urinary tract infections (except complicated pyelonephritis)
Danish: • Komplicerede urinvejsinfektioner (undtagen kompliceret pyelonefritis)
English: Complicated skin and soft tissue infections / Complicated skin and skin structure infections
Danish: Komplicerede infektioner i hud og bløddele/komplicerede infektioner i hud og bløde strukturer
English: (complicated or uncomplicated) o Infections of bones (osteitis, osteomyelitis) o Bone and joint infections o Gram negative infection of bones and joints o Bone infections (such as osteomyelitis and orthopaedic material/implant infection, especially when used in association with other antibiotics like rifampicin o Alternative form of treatment for bones and joints infections
Danish: (kompliceret eller ukompliceret) o Knogleinfektioner (osteitis, osteomyelitis) o Knogle- og ledinfektioner o Gram-negativ infektion i knogler og led o Knogleinfektioner (såsom osteomyelitis og infektion fra ortopædisk materiale/implantation, især når det anvendes sammen med andre antibiotika, såsom rifampicin o Alternativ behandlingsform til knogle- og ledinfektioner
English: Ear, nose and throat infections o Ear, nose and throat infections (with the exception of acute tonsillitis)
Danish: • Øre-, næse- og halsinfektioner o Øre-, næse- og halsinfektioner (med undtagelse af akut tonsillitis)
English: Acute bacterial rhinosinusitis
Danish: Akut bakteriel rhinosinuitis
English: For quinolones and fluoroquinolones containing medicinal products, the existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below (new text underlined and in bold, deleted text strike through):
Danish: For lægemidler, der indeholder quinoloner og fluoroquinoloner, skal den eksisterende indlægsseddel ændres (indsætning, udskiftning eller sletning af tekst hvor det er relevant) for at afspejle den godkendte ordlyd nedenfor (ny tekst med understregning og fed skrift, slettet tekst med gennemstregning):
English: • Pulmonary infections o Pulmonary infections [such as: acute exacerbation of chronic bronchitis, exacerbation of cystic fibrosis, nosocomial pneumonia, pulmonary tuberculosis by resistant mycobacteria, especially in immunocompromised patients (minor anti-tuberculosis medicine)]
Danish: • Lungeinfektioner o Lungeinfektioner [såsom: akut forværring af kronisk bronkitis, forværring af cystisk fibrose, hospitalserhvervet pneumoni, lungetuberkulose fra resistente mykobakterier, især hos immunkompromitterede patienter (andenvalgsbehandling af tuberkulose)]
English: • Prophylaxis of infectious gastroenteritis (traveller's diarrhoea)
Danish: • Profylakse af infektiøs gastroenteritis (rejsediarré)
English: • Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
Danish: • Bronkopulmonale infektioner ved cystisk fibrose forårsaget af Pseudomonas aeruginosa
English: Note: the indications are grouped under headings or cover terms that encompass the same medical entity; all changes apply to both the cover term and sub-headings, as relevant.
Danish: Bemærk: Indikationerne er inddelt i grupper med overskrifter eller punkter, der dækker den samme aktive substans.
English: • Prevention of infections due to ofloxacin susceptible pathogens (prophylaxis of infections, in patients with a significant reduction in resistance to infections (e.g., in neutropenic states)
Danish: • Forebyggelse af infektioner på grund af patogener følsomme for ofloxacin (profylakse af infektioner hos patienter med en signifikant reduktion i modstandsdygtigheden mod infektioner (f.eks. i neutropene stadier)
English: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.
Danish: Meget sjældne tilfælde af langvarige (fortsætter i måneder eller år), invaliderende og potentielt irreversible alvorlige bivirkninger, der påvirker forskellige, nogle gange flere, kropssystemer (det muskuloskeletale system, nervesystemet, psyken og sanseorganer) er blevet rapporteret hos patienter, der fik quinoloner og fluoroquinoloner, uanset alder og præeksisterende risikofaktorer.
English: • Bacterial prostatitis, epididymoorchitis
Danish: • Bakteriel prostatitis, epididymoorkitis
English: • Acute cystitis in women
Danish: • Akut cystitis hos kvinder
English: Current category 1 indications in product information of moxifloxacin
Danish: Aktuelle kategori 1-indikationer i produktinformationen for moxifloxacin