FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Bolnikom, ki se zdravijo s/z [INN], je treba svetovati, da morajo pred nadaljevanjem zdravljenja obvestiti zdravnika, če se pojavijo simptomi nevropatije, npr. bolečina, žarenje, mravljinčenje, odrevenelost ali šibkost, da se prepreči razvoj potencialno ireverzibilnega stanja (glejte poglavje 4.8).
English: • Pulmonary tuberculosis by resistant mycobacteria, especially in immunocompromised patients (minor anti-tuberculosis medicine)
Slovenian: • Pljučna tuberkuloza, ki jo povzročajo odporne mikobakterije, predvsem pri imunokompromitiranih bolnikih (manj uporabljana zdravila proti tuberkulozi)
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
Slovenian: • Preprečevanje potovalne driske Predoperativna priprava za kronični holesteatomatozni otitis in kronični otitis, ki se je razširil na kost Septikemija Selektivna dekontaminacija prebavil pri bolnikih s kompromitiranim imunskim sistemom Preprečevanje poslabšanj pri ženskah s ponavljajočimi se okužbami sečil
English: • Prophylaxis of infectious gastroenteritis (traveller's diarrhoea)
Slovenian: • Profilaksa infekcijskega gastroenteritisa (potovalne driske)
English: • Tonsillitis Laryngitis Acute bronchitis Prophylaxis of travellers´ diarrhoea
Slovenian: • Tonzilitis Laringitis Akutni bronhitis Profilaksa potovalne driske
English: 1.1 Deletion of indications 1.1.1 For all quinolones/fluoroquinolones
Slovenian: 1.1 Izbris indikacij 1.1.1 Za vse kinolone/fluorokinolone
English: • Complicated urinary tract infections (except complicated pyelonephritis)
Slovenian: • Zapletene okužbe sečil (razen zapletenega pielonefritisa)
English: • Superinfection of chronic otitis (whatever its nature) and cavities after mastodectomy
Slovenian: • Superinfekcija kroničnega otitisa (vseh vrst) in votlin po mastodektomiji
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
Slovenian: • Gastroenteritis o Bakterijski gastroenteritis o Gastroenteritis o Akutni bakterijski gastroenteritis o Bakterijski enteritis o Akutni bakterijski gastroenteritis po kulturi blata in laboratorijski potrditvi občutljivosti povzročitelja na NOROCIN
English: • Inhalation anthrax: post-exposure prophylaxis and curative treatment
Slovenian: • Inhalacijski vranični prisad: profilaksa po izpostavitvi povzročitelju in zdravljenje
English: Complicated skin and soft tissue infections / Complicated skin and skin structure infections
Slovenian: Zapletene okužbe kože in mehkih tkiv/Zapletene okužbe kože in kožnih struktur
English: Gynaecological infections o Gynaecological infections
Slovenian: • Ginekološke okužbe o Ginekološke okužbe
English: • Gonorrhoea o gonorrhoea o uncomplicated gonorrhea o Gonococcal urethritis, pharyngitis, proctitis or cervicitis from Neisseria gonorrhoeae irrespective of the production of penicillinase.
Slovenian: • Gonoreja o Gonoreja o Nezapletena gonoreja o Gonokokni uretritis, faringitis, proktitis ali cervicitis zaradi Neisseria gonorrhoeae, ne glede na proizvodnjo penicilinaze.
English: pyelitis,
Slovenian: pielitis,
English: A - Summary of product characteristics (SmPC)
Slovenian: A - Povzetek glavnih značilnosti zdravila
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
Slovenian: • Profilaksa po operacijah ali posegih v urogenitalnem sistemu o profilaksa po operacijah ali posegih v urogenitalnem sistemu o profilaksa ponavljajočih se okužb sečil po transuretralni operaciji ali transrektalni biopsiji prostate
English: 1.2 Amendment of indications 1.2.1 For all quinolones/fluoroquinolones
Slovenian: 1.2 Sprememba indikacij 1.2.1 Vsi kinoloni/fluorokinoloni
English: Recommended wording o Urinary tract infections (acute or recurrent cystitis, acute uncomplicated pyelonephritis)
Slovenian: Priporočeno besedilo o Okužbe sečil (akutni ali ponavljajoči se cistitis, akutni nezapleteni pielonefritis)
English: • Acute exacerbation of chronic bronchitis (last line)
Slovenian: • Akutno poslabšanje kroničnega bronhitisa (zadnja izbira)
English: • Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
Slovenian: • Bronhopulmonalne okužbe pri cistični fibrozi, ki jih povzroča Pseudomonas aeruginosa
English: • Severe skin and soft-tissue infections (last line)
Slovenian: • Hude okužbe kože in mehkih tkiv (zadnja izbira)
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):
Slovenian: Obstoječe informacije o zdravilih, ki vsebujejo kinolone in fluorokinolone, se spremenijo (z vstavljanjem, nadomeščanjem ali brisanjem besedila, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj (novo besedilo je podčrtano in krepko, izbrisano besedilo je prečrtano):
English: • Bacterial prostatitis
Slovenian: • Bakterijski prostatitis
English: • Simple uncomplicated acute cystitis in the premenopausal adult women
Slovenian: • Nezapleteni akutni cistitis pri odraslih ženskah pred menopavzo
English: • Treatment of ofloxacin sensitive prophylaxis of bacterial infections in patients with weakened resistance (for example neutropenic patients)
Slovenian: • Profilaktično zdravljenje bakterijskih okužb z bakterijami, občutljivimi na ofloksacin, pri bolnikih z oslabljeno odpornostjo (na primer nevtropenični bolniki)
English: Section 4.
Slovenian: Priloga III
English: • Bacterial gastroenteritis o Bacterial gastroenteritis o Bacterial enteritis o Intestinal infections o bacterial diarrhoea, which needs antibacterial treatment
Slovenian: • Bakterijski gastroenteritis o Bakterijski gastroenteritis o Bakterijski enteritis o Okužbe črevesja o Bakterijska driska, ki jo je treba zdraviti s protibakterijskimi zdravili
English: Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely.
Slovenian: Redko se lahko pojavita bolečina in oteklina sklepov ter vnetje ali pretrganje kit.
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):
Slovenian: Obstoječe navodilo za uporabo za zdravila, ki vsebujejo kinolone in fluorokinolone, se spremeni (z vstavljanjem, nadomeščanjem ali brisanjem besedila, kot je ustrezno) tako, da vsebuje dogovorjeno besedilo, kot je navedeno spodaj (novo besedilo je podčrtano in krepko, izbrisano besedilo je prečrtano):
English: • Acute urinary tract infections in men o acute urinary tract infections in men o acute infection of lower urinary tract infections in men
Slovenian: • Akutne okužbe sečil pri moških o Akutne okužbe sečil pri moških o Akutne okužbe spodnjih sečil pri moških
English: Skin and soft tissue infections o Skin and soft tissue infections o Gram negative infection of skin and soft tissue o Skin and soft tissues infections or infections of traumas from microbes such as Ε. coli, K. pneumoniae, Enterobacter, P. mirabilis and P. vulgaris, Providencia, Citrobacter, P. aeruginosa, S. aureus
Slovenian: • Okužbe kože in mehkega tkiva o Okužbe kože in mehkega tkiva o Gramnegativne okužbe kože in mehkega tkiva o Okužbe kože in mehkega tkiva ali okužbe travm, ki jih povzročijo mikrobi, kot so Ε. coli, K. pneumoniae, Enterobacter, P. mirabilis in P. vulgaris, Providencia, Citrobacter, P. aeruginosa, S. aureus
English: • Acute cystitis in women
Slovenian: • Akutni cistitis pri ženskah
English: Bronchial suppurations, in the absence of any parenchymal lesion
Slovenian: • Bronhialne supuracije, v odsotnosti parenhimskih lezij:
English: • Salmonella infections (carrier) • Germ carrying of salmonellosis
Slovenian: • Okužbe s salmonelo (nosilci okužbe) • Klice, ki prenašajo salmonelozo
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.
Slovenian: Trenutni opozorilni stavek o perifernih nevropatijah mora vsebovati vsaj naslednje informacije: Redko se lahko pojavijo simptomi poškodbe živcev (nevropatija), kot so bolečina, žarenje, mravljinčenje, odrevenelost in/ali šibkost, zlasti v stopalih in nogah ali dlaneh in rokah.
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)
Slovenian: • Preprečevanje okužb zaradi patogenov, občutljivih na ofloksacin (profilaksa okužb pri bolnikih z močno zmanjšano odpornostjo na okužbe (npr. v nevtropeničnih stanjih))
English: • Bronchial suppurations, in the absence of any parenchymal lesion: In subjects at risk (chronic alcoholism, smoking, subjects over 65 years)
Slovenian: Pri osebah, pri katerih obstaja tveganje (kronični alkoholizem, kajenje, osebe nad 65 let)
English: • Pharyngitis
Slovenian: • Faringitis
English: • Severe/Serious gastro-intestinal bacterial infections
Slovenian: • Hude/resne bakterijske okužbe želodca in črevesja
English: • Acute pyelonephritis • Uncomplicated acute pyelonephritis
Slovenian: • Akutni pielonefritis • Nezapleteni akutni pielonefritis
English: • Bacterial prostatitis, epididymoorchitis
Slovenian: • Bakterijski prostatitis, epididimo-orhitis
English: This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.
Slovenian: To vključuje bolečine v kitah, mišicah in sklepih zgornjih in spodnjih okončin, težave pri hoji, nenormalne občutke, kot so mravljinčenje, ščegetanje, odrevenelost ali žarenje (parestezija), motnje funkcije čutil, vključno z okvaro vida, okusa, vonja in sluha, depresijo, motnje spomina, hudo utrujenost in hude motnje spanja.
English: Acute bacterial rhinosinusitis
Slovenian: Akutni bakterijski rinosinusitis
English: • Exacerbations of broncho-pulmonary infections in cystic fibrosis
Slovenian: • Poslabšanje bronhopulmonalnih okužb pri cistični fibrozi
English: • Acute pyelonephritis and complicated urinary tract infections (see section 4.4)
Slovenian: • Akutni pielonefritis in zapletene okužbe sečil (glejte poglavje 4.4)
English: The warning on tendinopathies / tendon disorders should be included/ amended as follows: Tendinitis and tendon rupture
Slovenian: Vključiti/spremeniti je treba opozorilo o tendinopatijah/boleznih tetiv, kot sledi:
English: • Cystitis o Cystitis o Acute and chronic cystitis in women
Slovenian: • Cistitis o Cistitis o Akutni in kronični cistitis pri ženskah
English: • Urinary tract and related infections o Complicated and uncomplicated, acute and chronic, upper and lower urinary tract infections.
Slovenian: • Okužbe sečil in povezane okužbe o Zapletene in nezapletene, akutne in kronične okužbe zgornjih in spodnjih sečil.
English: • Malignant external otitis
Slovenian: • Maligno vnetje zunanjega ušesa
English: • Perioperative prophylaxis in invasive urological surgery
Slovenian: • Perioperativna profilaksa pri invazivnih uroloških posegih
English: • Pelvic inflammatory disease, in combination treatment o Acute pelvic inflammatory disease o Pelvic inflammatory disease, in combination treatment o Pelvic region infection in women (in combination with other antibiotics) o Inflammatory pelvic disease, in combinations treatment o Upper genital tract infection in women (see 4.4) (complicated or uncomplicated) o Upper gynaecological tract infections, including infections due to susceptible strains of Neisseria gonorrhoeae
Slovenian: • Medenična vnetna bolezen, pri kombiniranem zdravljenju o Akutna medenična vnetna bolezen o Medenična vnetna bolezen, pri kombiniranem zdravljenju o Vnetje medeničnega predela pri ženskah (v kombinaciji z drugimi antibiotiki) o Vnetna bolezen medenice, pri kombiniranem zdravljenju o Okužba zgornjega genitalnega trakta pri ženskah (glejte poglavje 4.4) (zapletena ali nezapletena) o Okužbe zgornjega ginekološkega trakta, vključno z okužbami zaradi občutljivih sevov bakterije Neisseria gonorrhoeae
English: • Acute uncomplicated infection of lower urinary tract (simple cystitis)
Slovenian: • Akutna nezapletena okužba spodnjih sečil (cistitis)
English: • Pulmonary infections o Pulmonary infections (acute exacerbation of chronic bronchitis, exacerbation of cystic fibrosis, nosocomial pneumonia)
Slovenian: • Pljučne okužbe o Pljučne okužbe (akutno poslabšanje kroničnega bronhitisa, poslabšanje cistične fibroze, nozokomialna pljučnica)
English: Levofloxacin
Slovenian: Levofloksacin
English: Current category 1 indications in product information of moxifloxacin
Slovenian: Trenutne indikacije kategorije 1 v informacijah o zdravilu za moksifloksacin
English: o Uncomplicated acute gonococcal urethritis and cervicitis o Gonococcal urethritis due to susceptible strains of Neisseria gonorrhoeae and non-gonococcal urethritis
Slovenian: o Nezapleteni akutni gonokokni uretritis in cervicitis o Gonokokni uretritis zaradi občutljivih sevov bakterije Neisseria gonorrhoeae in negonokokni uretritis
English: • Acute sinusitis
Slovenian: • Akutni sinusitis
English: • Acute bacterial prostatitis
Slovenian: • Akutni bakterijski prostatitis
English: • skin and soft tissue infections • skin and soft structure infections
Slovenian: • Okužbe kože in mehkih tkiv • Okužbe kože in mehkih struktur
English: • Non-gonococcal urethritis and cervicitis
Slovenian: • Negonokokni uretritis in cervicitis
English: • Chronic sinusitis
Slovenian: • Kronični sinusitis
English: • Urosepsis (only applicable for i.v.
Slovenian: • Urosepsa (velja le za intravensko farmacevtsko obliko)
English: • Exacerbation of chronic obstructive pulmonary disease
Slovenian: • Poslabšanje kronične obstruktivne pljučne bolezni
English: • Infections of the bones and joints
Slovenian: • Okužbe kosti in sklepov
English: Acute exacerbation of chronic bronchitis and of chronic obstructive pulmonary disease
Slovenian: Akutno poslabšanje kroničnega bronhitisa in kronične obstruktivne pljučne bolezni
English: • Complicated cystitis o chronic cystitis in women
Slovenian: • Zapleteni cistitis o Kronični cistitis pri ženskah
English: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.
Slovenian: Pri bolnikih, ki so prejemali kinolone in fluorokinolone, so poročali o primerih senzorične ali senzorično-motorične polinevropatije, ki se je izražala kot parestezija, hipestezija, disestezija ali šibkost.
English: • Lower respiratory tract infections
Slovenian: • Okužbe spodnjih dihal
English: Vaginal infections
Slovenian: Okužbe nožnice
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
Slovenian: • Okužbe kosti in sklepov (zadnja izbira) o Okužbe kosti in sklepov: kot sta osteomielitis ali septični artritis (zapleteni ali nezapleteni) o Okužbe kosti (osteitis, osteomielitis) o Okužbe kosti in sklepov o Gramnegativne okužbe kosti in sklepov o Okužbe kosti (kot so osteomielitis in okužbe ortopedskega materiala/vsadkov, zlasti pri uporabi v kombinaciji z drugimi antibiotiki, kot je rifampicin) o Alternativne oblike zdravljenja okužb kosti in sklepov
English: • Skin and soft tissue infections o Skin infections o Skin infection - severe infections caused by gram-negative bacilli and susceptible staphylococci o Skin and soft tissue infections by penicillin resistant Staphylococcus o Infections of skin and soft tissue caused by staphylococcus resistant to penicillin
Slovenian: • Okužbe kože in mehkega tkiva o Okužbe kože o Okužbe kože - hude okužbe, ki jih povzročajo gramnegativni bacili in občutljivi stafilokoki o Okužbe kože in mehkega tkiva zaradi proti penicilinu odporne bakterije Staphylococcus o Okužbe kože in mehkega tkiva, ki jih povzročajo proti penicilinu odporne bakterije Staphylococcus
English: Current category 1 indications in product information of levofloxacin
Slovenian: Trenutne indikacije kategorije 1 v informacijah o zdravilu za levofloksacin
English: • Acute exacerbations of chronic bronchitis
Slovenian: • Akutna poslabšanja kroničnega bronhitisa
English: Lomefloxacin Current indications in product information for lomefloxacin containing products
Slovenian: Lomefloksacin Trenutne indikacije v informacijah o zdravilu za zdravila, ki vsebujejo lomefloksacin
English: Possible side effects
Slovenian: 4. poglavje: Možni neželeni učinki
English: • Recurrent cystitis in women
Slovenian: • Ponavljajoči se cistitis pri ženskah
English: • Acute bacterial sinusitis.
Slovenian: • Akutni bakterijski sinusitis.
English: (complicated or uncomplicated) o Prostatitis by E. coli o Prostatitis, epididymo-orchitis o Prostatitis, infection of the epididymis and the testicle o severe prostatitis
Slovenian: • Prostatitis, epididimo-orhitis o Kronični bakterijski prostatitis (zapleteni ali nezapleteni) o Prostatitis, ki ga povzroča E. coli o Prostatitis, epididimo-orhitis o Prostatitis, okužba epididimisa in mod o Hud prostatitis
English: • Respiratory infections o Acute, chronic or recurrent respiratory tract infections; superior - acute otitis media, otitis externa, sinusitis, pharyngitis and laryngitis o Acute, chronic or recurrent respiratory tract infections caused by Haemophilus influenzae or other Gram-negative or multi-resistant pathogens, as well as by Staphylococcus aureus o Respiratory tract infections (with the exception, if infection is of pneumococcal origin or is suspected) o Severe respiratory infections caused by gram-negative bacilli and susceptible staphylococci o Lower respiratory tract infections
Slovenian: • Okužbe dihal o Akutna, kronična ali ponavljajoča se vnetja dihal; superiorno - akutno vnetje srednjega ušesa, vnetje zunanjega ušesa, sinusitis, faringitis in laringitis o Akutna, kronična ali ponavljajoča se vnetja dihal, ki jih povzročajo Haemophilus influenzae ali drugi gramnegativni ali multirezistentni patogeni ter Staphylococcus aureus o Okužbe dihal (z izjemo potrditve okužbe pnevmokoknega izvora ali suma na tako okužbo) o Hude okužbe dihal, ki jih povzročajo gramnegativni bacili in občutljivi stafilokoki o Okužbe spodnjih dihal
English: • Chronic bacterial sinusitis
Slovenian: • Kronični bakterijski sinusitis
English: • Complicated skin and soft tissue infections.
Slovenian: • Zapletene okužbe kože in mehkih tkiv.
English: • Acute urinary tract infection in men
Slovenian: • Akutna okužba sečil pri moških
English: • Treatment of infections in neutropenic patients
Slovenian: • Zdravljenje okužb pri nevtropeničnih bolnikih
English: • Uncomplicated pyelonephritis o uncomplicated pyelonephritis o acute uncomplicated pyelonephritis in women
Slovenian: • Nezapleteni pielonefritis o Nezapleteni pielonefritis o Akutni nezapleteni pielonefritis pri ženskah
English: • Prostatitis o prostatitis o chronic bacterial prostatitis o Acute prostatitis caused by Escherichia coli
Slovenian: • Prostatitis o Prostatitis o Kronični bakterijski prostatitis o Akutni prostatitis, ki ga povzroča
English: • Genital tract infections o Genital infections (chronic prostatitis) o Genital tract infection - severe infections caused by gramnegative bacilli and susceptible staphylococci
Slovenian: • Okužbe genitalnega trakta o Okužbe spolovil (kronični prostatitis) o Okužbe genitalnega trakta - hude okužbe, ki jih povzročajo gramnegativni bacili in občutljivi stafilokoki
English: Ear and labyrinth disorders*
Slovenian: Ušesne bolezni, vključno z motnjami labirinta*
English: The following new wording should be included after listing of side effects:
Slovenian: Za naštetimi neželenimi učinki je treba vključiti naslednje novo besedilo:
English: Lower respiratory tract infections
Slovenian: Okužbe spodnjih dihal
English: • Bone and joint infections (gram negative osteomyelitis)
Slovenian: • Okužbe kosti in sklepov (gramnegativni osteomielitis)
English: Chronic ear, nose and throat infections o Severe chronic ENT infections caused by gram-negative bacilli and susceptible staphylococci o Chronic and recurrent infections of the nose, throat and ear, only when caused by Gram-negative pathogens, including Pseudomonas, or by Staphylococci o Chronic and recurrent infections of ears, nose and throat, above all if they are caused by gram-negative bacteria including Pseudomonas, or if they are caused by Staphylococcus o Ear, nose and throat (ENT) infections (such as: chronic sinusitis, superinfection in chronic otitis, prophylaxis of infections following inner ear surgery)
Slovenian: • Kronične okužbe ušes, nosu in žrela o Hude kronične okužbe ORL, ki jih povzročajo gramnegativni bacili in občutljivi stafilokoki o Kronične in ponavljajoče se okužbe nosu, žrela in ušesa, samo če jih povzročajo gramnegativni patogeni, vključno s Pseudomonas, ali stafilokoki o Kronične in ponavljajoče se okužbe ušes, nosu in žrela, zlasti če jih povzročajo gramnegativne bakterije, vključno s Pseudomonas, ali Staphylococcus o (ORL) okužbe ušes, nosu in žrela (kot so: kronični sinusitis, superinfekcija pri kroničnem otitisu, profilaksa okužb po operaciji notranjega ušesa) o Kronične in ponavljajoče se otorinolaringološke okužbe
English: • Lower urinary tract infections o Acute and chronic lower urinary tract infections
Slovenian: • Zapletene okužbe spodnjih sečil o Akutne in kronične okužbe spodnjih sečil
English: • Frequent, recurrent urinary infection prophylaxis
Slovenian: • Profilaksa pogostih, ponavljajočih se okužb sečil