natgillin/translations-raw huggingface dataset:
Behandling af infektioner, der skyldes visse bakterier (f. eks.
Treatment of infections due to certain bacteria (e. g.
Pseudomonas aeruginosa, Acinetobacter eller Stafylokokker), kan kræve højere ciprofloxacindoser og samtidig indgift af andre passende antibakterielle midler.
Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.
Behandling af nogle infektioner (f. eks. underlivsbetændelse, intraabdominale infektioner, infektioner hos neutropeniske patienter og infektioner i knogler og led) kan kræve samtidig indgift af andre passende antibakterielle midler, afhængigt af de involverede patogener.
Treatment of some infections (e. g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.
Behandlingsvarighed (inklusiv evt. initial
Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin)
parenteral behandling med ciprofloxacin) Infektioner i de nedre luftveje (iht. sværhedsgrad og organisme)
respiratory tract
7- 14 dage
7
Infektioner i de Akut exacerbation af øvre luftvej (iht. kronisk sinusitis sværhedsgrad og
Acute exacerbation of chronic sinusitis
7- 14 dage
7 to 14 days
Daglig dosis i mg
tract
28 dage
28 days up to 3 months
op til 3 måneder
Daily dose in mg
Urinvejsinfektioner (iht. sværhedsgrad og organisme)
Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin)
Hos præ- menopausale kvinder
In pre-menopausal women, 500 mg single dose may be used
kan der
Complicated cystitis, Uncomplicated pyelonephritis
gives 500 mg som
500 mg twice daily
éngangsdosis
7 days
Kompliceret cystitis, Ukompliceret pyelonephritis
Complicated
500 mg to gange dagligt
500 mg twice daily to
7 dage
at least 10 days, it can be
Kompliceret pyelonephritis
pyelonephritis
500 mg to gange dagligt op til 750 mg to gange dagligt
750 mg twice daily
Mindst 10 dage, i nogle tilfælde kan behandlingen fortsætte i længere end 21 dage (f. eks. ved abscesser)
continued for longer than 21 days in some specific circumstances (such as abscesses)
Prostatitis
Prostatitis
2- 4 uger (akut) til 4- 6 uger (kronisk)
2 to 4 weeks (acute) to 4 to 6 weeks (chronic)
Epididymoorchitis og underlivsbetændelse
Epididymo-orchitis and pelvic inflammatory diseases
Gastrointestinale og intraabdominale infektioner
Infections of the gastro-intestinal tract and intra- abdominal infections
Diaré forårsaget af patogene bakterier, herunder Shigella spp., bortset fra Shigella dysenteriae type 1 og empirisk behandling af svær rejsediaré
Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea
Tyfus Intraabdominale infektioner, som skyldes gramnegative bakterier
Typhoid fever Intra-abdominal infections due to Gram-negative bacteria
500 mg to gange dagligt 500 mg to gange dagligt op til 750 mg to gange dagligt
500 mg twice daily 500 mg twice daily to 750 mg twice daily
7 dage 5- 14 dage
7 days 5 to 14 days
Infektioner i hud og bløddele
Infections of the skin
Behandling af infektioner eller profylakse over for infektioner hos patienter med neutropeni
Treatment of infections or prophylaxis of infections in neutropenic patients Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.
Indikationer Ciprofloxacin skal gives sammen med andre antibakterielle stoffer i henhold til officielle retningslinjer.
Prophylaxis of invasive infections due to Neisseria meningitidis
Daglig dosis i mg
500 mg as a single dose
Profylakse ved invasive infektioner, som skyldes Neisseria meningitidis
1 day (single dose)
500 mg som éngangsdosis
23 Indications
1 dag (éngangsdosis)
Daily dose in mg
Behandling skal påbegyndes så hurtigt som muligt efter mistanke om eller bekræftet eksponering.
Drug administration should begin as soon as possible after suspected or confirmed exposure.
Behandlingsvarighed
Total duration of
(inklusiv evt. parenteral behandling med ciprofloxacin) Cystisk fibrose
treatment (potentially including initial parenteral treatment with ciprofloxacin) Cystic fibrosis
20 mg/ kg legemsvægt to gange dagligt, maksimalt 750 mg pr. dosis.
20 mg/ kg body weight twice daily with a maximum of 750 mg per dose.
10- 14 dage
10 to 14 days
10 mg/ kg op til 20 mg/ kg legemsvægt to gange dagligt, maksimalt 750 mg pr. dosis.
10 mg/ kg body weight twice daily to 20 mg/ kg body weight twice daily with a maximum of 750 mg per dose.
10- 21 dage
10 to 21 days
Inhalationsanthrax, profylakse efter eksponering og kurativ behandling til patienter, som kan behandles oralt, når det er klinisk passende.
post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
Behandlingen skal påbegyndes så hurtigt som muligt efter mistanke om eller bekræftet eksponering.
Drug administration should begin as soon as possible after suspected or confirmed exposure.
10 mg/ kg op til 15 mg/ kg legemsvægt to gange dagligt, maksimalt 500 mg pr. dosis.
weight twice daily with a maximum of 500 mg per dose.
dage efter bekræftelse af eksponering for Bacillus anthracis
confirmation of Bacillus anthracis exposure
Ældre patienter
Geriatric patients
Ældre patienter skal have en dosis, der fastsættes ud fra infektionens alvorlighed og patientens kreatininclearance.
Geriatric patients should receive a dose selected according to the severity of the infection and the patient’ s creatinine clearance.
25 Nedsat nyre - og leverfunktion
Renal and hepatic impairment
Anbefalede start - og vedligeholdelsesdoser til patienter med nedsat nyrefunktion:
Recommended starting and maintenance doses for patients with impaired renal function:
Kreatininclearance [ml/ min / 1, 73m²]
Creatinine Clearance [mL/ min/ 1.73 m²]
Serumkreatinin [µmol/ l]
Serum Creatinine [µmol/ L]
Oral dosis [mg]
Oral Dose [mg]
Se normaldosering.
See Usual Dosage.
30- 60
30-60 < 30 Patients on haemodialysis
124 til 168
124 to 168 > 169 > 169
250- 500 mg hver 24. time (efter dialyse)
250-500 mg every 12 h 250-500 mg every 24 h 250-500 mg every 24 h (after dialysis)
250- 500 mg hver 24. time
250-500 mg every 24 h
Doseringen til børn med nedsat nyre - og/ eller leverfunktion er ikke undersøgt.
Dosing in children with impaired renal and/ or hepatic function has not been studied.
4. 5).
Ciprofloxacin tablets should not be taken with dairy products (e. g. milk, yoghurt) or mineral-fortified fruit-juice (e. g. calcium-fortified orange juice) (see section 4.5).
I svære tilfælde, eller hvis patienten ikke kan indtage tabletter (f. eks. patienter, som får enteral ernæring), bør behandlingen påbegyndes med intravenøs ciprofloxacin, indtil det er muligt at skifte til oral indgift.
In severe cases or if the patient is unable to take tablets (e. g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.
6. 1).
• Hypersensitivity to the active substance, to other quinolones or to any of the excipients (see section 6.1).
4. 5).
• Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).
Ved sådanne infektioner skal ciprofloxacin gives sammen med andre passende antibakterielle midler.
In such infections ciprofloxacin must be co- administered with other appropriate antibacterial agents.
Genitale infektioner Epidymoorchitis og underlivsbetændelse kan være forårsaget af fluoroquinolonresistente Neisseria gonorhoeae.
Genital tract infections Epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae.
26 Intra- abdominale infektioner Der er begrænsede data om virkningen af ciprofloxacin til behandling af postoperative intra - abdominale infektioner.
Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Rejsediaré Ved valget af ciprofloxacin skal der tages hensyn til resistensen over for ciprofloxacin hos relevante patogener i de lande, der besøges.
Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
Infektioner i knogler og led Ciprofloxacin bør anvendes i kombination med andre antibakterielle lægemidler, afhængigt af resultaterne af de mikrobiologiske undersøgelser.
25 Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Inhalationsanthrax Anvendelsen hos mennesker er baseret på oplysninger om in vitro- disposition og på dyreforsøg samt begrænsede oplysninger fra mennesker.
Inhalational anthrax Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data.
Behandlende læger skal henholde sig til national og/ eller international konsensusdokumentation om behandling af anthrax.
Treating physicians should refer to national and/ or international consensus documents regarding the treatment of anthrax.
Børn og unge Anvendelsen af ciprofloxacin til børn og unge skal ske i henhold til tilgængelig officiel vejledning.
Children and adolescents The use of ciprofloxacin in children and adolescents should follow available official guidance.
Ciprofloxacin- behandling må kun påbegyndes af en læge, der har erfaring i behandling af cystisk fibrose og/ eller svære infektioner hos børn og unge.
Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/ or severe infections in children and adolescents.
1 til 17 år) viste en hyppighed af formodet lægemiddelrelateret artropati (bedømt ud fra ledrelaterede kliniske symptomer) efter dag 42 på hhv.
Safety data from a randomised double-blind study on ciprofloxacin use in children (ciprofloxacin: n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years) revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%.
Efter 1- års follow- up var den lægemiddelrelaterede hyppighed af artropati hhv.
Respectively, an incidence of drug-related arthropathy by 1-year follow-up was 9.0% and 5.7%.
På grund af bivirkninger, som kan være relateret til led og/ eller det omgivende væv, bør behandlingen kun påbegyndes efter en omhyggelig vurdering af risici og fordele.
Treatment should be initiated only after a careful benefit/ risk evaluation, due to possible adverse events related to joints and/ or surrounding tissue.
Bronkopulmonale infektioner ved cystisk fibrose Kliniske studier har inkluderet børn og unge i alderen 5- 17 år.
Broncho-pulmonary infections in cystic fibrosis Clinical trials have included children and adolescents aged 5-17 years.
Behandlingen bør ske på grundlag af resultaterne af mikrobiologiske undersøgelser.
Complicated urinary tract infections and pyelonephritis Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation.
Kliniske studier har inkluderet børn og unge i alderen 1- 17 år.
Clinical trials have included children and adolescents aged 1-17 years.
Andre specifikke svære infektioner Efter en omhyggelig vurdering af risici og fordele, og i overensstemmelse med mikrobiologiske undersøgelser kan andre svære infektioner behandles med ciprofloxacin, i henhold til den officielle vejledning, hvis andre behandlinger ikke kan bruges eller efter svigt af konventionel behandling.
Other specific severe infections Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.
4. 8).
Hypersensitivity Hypersensitivity and allergic reactions, including anaphylaxis and anaphylactoid reactions, may occur following a single dose (see section 4.8) and may be life-threatening.
27 Det muskuloskeletale system Ciprofloxacin bør generelt ikke bruges til patienter, som har haft senesygdomme relateret til behandling med quinoloner.
Musculoskeletal System Ciprofloxacin should generally not be used in patients with a history of tendon disease/ disorder related to quinolone treatment.
Dette gælder især, hvis standardbehandlingen har svigtet, eller der er bakteriel resistens, hvor de mikrobiologiske data berettiger anvendelsen af ciprofloxacin.
Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/ benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of ciprofloxacin.
Allerede 48 timer efter start af behandlingen med ciprofloxacin kan der forekomme tendinitis og seneruptur (specielt af akillessenen), af og til bilateralt.
26 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
4. 8).
The risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated with corticosteroids (see section 4.8).
Ved tegn på tendinitis (f. eks. smertefuld hævelse eller inflammation), skal behandlingen med ciprofloxacin seponeres.
At any sign of tendinitis (e. g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued.
4. 8).
Ciprofloxacin should be used with caution in patients with myasthenia gravis (see section 4.8).
Fotosensitivitet Det er vist, at ciprofloxacin kan forårsage fotosensitivitetsreaktioner.
Photosensitivity Ciprofloxacin has been shown to cause photosensitivity reactions.
4. 8).
Patients taking ciprofloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment (see section 4.8).
Centralnervesystemet Quinoloner er kendt for at kunne udløse krampeanfald eller sænke krampetærsklen.
Central Nervous System Quinolones are known to trigger seizures or lower the seizure threshold.
Hvis der forekommer krampeanfald, skal ciprofloxacin seponeres (se pkt 4. 8).
If seizures occur ciprofloxacin should be discontinued (see section 4.8).
I sjældne tilfælde kan en depression eller psykose udvikle sig således, at patienten bliver til fare for sig selv.
In rare cases, depression or psychosis can progress to self- endangering behaviour.
Der er indberetninger om polyneuropati (baseret på neurologiske symptomer som f. eks. smerter, brænden, sensoriske forstyrrelser eller muskelsvaghed, alene eller i kombination) hos patienter, som får ciprofloxacin.
Cases of polyneuropathy (based on neurological symptoms such as pain, burning, sensory disturbances or muscle weakness, alone or in combination) have been reported in patients receiving ciprofloxacin.
4. 8).
Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness, and/ or weakness in order to prevent the development of an irreversible condition (see section 4.8).
4. 8), skal der iagttages forsigtighed ved behandling af patienter med torsades de point- arytmi.
Cardiac disorders Since ciprofloxacin is associated with cases of QT prolongation (see section 4.8), caution should be exercised when treating patients at risk for torsades de pointes arrhythmia.
4. 8).
Gastrointestinal System The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (life-threatening with possible fatal outcome), requiring immediate treatment (see section 4.8).
Nyre - og urinveje Der er indberettet tilfælde med krystalluri i forbindelse med brugen af ciprofloxacin (se pkt.
Renal and urinary system Crystalluria related to the use of ciprofloxacin has been reported (see section 4.8).
4. 8).
Hepatobiliary system Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see section 4.8).
Hvis der optræder symptomer på leversygdom (f. eks. anoreksi, gulsot, mørkfarvet urin, kløe eller abdominal ømhed), skal behandlingen seponeres.
In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.
Glucose- 6- phosphat dehydrogenase- mangel Hos patienter med glucose- 6- phosphat dehydrogenase- mangel er der indberetninger om hæmolytiske reaktioner ved behandling med ciprofloxacin.
Glucose-6-phosphate dehydrogenase deficiency Haemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency.
28 Resistens Under og efter behandling med ciprofloxacin kan bakterier, der viser resistens over for ciprofloxacin, isoleres, med eller uden klinisk tydelig superinfektion.
Resistance During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection.
Der kan være en særlig risiko ved ciprofloxacin- resistente bakterier ved længere behandlingsforløb og ved behandling af nosokomielle infektioner og/ eller infektioner, der skyldes Staphylococcus - og Pseudomonas- arter.
There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/ or infections caused by Staphylococcus and Pseudomonas species.
Cytokrom P450 Ciprofloxacin hæmmer CYP1A2 og kan derfor medføre øgede serumkoncentrationer af lægemidler, som gives samtidigt, og som metaboliseres af dette enzym (f. eks. teofyllin, clozapin, ropinirol og tizanidin).
27 Cytochrome P450 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, ropinirole, tizanidine).
4. 5).
Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e. g. of theophylline) may be necessary (see section 4.5).
4. 5).
Methotrexate The concomitant use of ciprofloxacin with methotrexate is not recommended (see section 4.5).
Interaktioner med laboratorietests Ciprofloxacins in vitro- aktivitet over for Mycobacterium tuberculosis kan resultere i falsk negative bakteriologiske testresultater i prøver fra patienter, som tager ciprofloxacin.
Interaction with tests The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin.
Virkninger af andre lægemidler på ciprofloxacin:
Effects of other products on ciprofloxacin:
Samtidig indgift af ciprofloxacin (oral) og lægemidler, som indeholder multivalente kationer, og mineraltilskud (f. eks. calcium, magnesium, aluminium og jern), fosfatbundne polymerer (f. eks. sevelamer), sucralfat eller antacida og stærkt bufrede lægemidler (f. eks. didanosintabletter), som indeholder magnesium, aluminium eller calcium, nedsætter absorptionen af ciprofloxacin.
The simultaneous administration of ciprofloxacin (oral) and multivalent cation-containing drugs and mineral supplements (e. g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e. g. sevelamer), sucralfate or antacids, and highly buffered drugs (e. g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin.
Derfor skal ciprofloxacin gives enten 1- 2 timer før eller mindst 4 timer efter indtagelsen af disse præparater.
Consequently, ciprofloxacin should be administered either 1-2 hours before or at least 4 hours after these preparations.
Denne restriktion vedrører ikke gruppen af H2- receptor- blokerende antacida.
The restriction does not apply to antacids belonging to the class of H2 receptor blockers.
Derimod bør samtidig indtagelse af mælkeprodukter (f. eks. mælk eller yoghurt) eller indtagelse af drikke tilsat mineraler (f. eks. orangejuice tilsat calcium) undgås samtidig med indtagelse af ciprofloxacin, fordi absorptionen af ciprofloxacin kan nedsættes.
However, the concurrent administration of dairy products or mineral-fortified drinks alone (e. g. milk, yoghurt, calcium-fortified orange juice) with ciprofloxacin should be avoided because absorption of ciprofloxacin may be reduced.
4. 3).
Tizanidine must not be administered together with ciprofloxacin (see section 4.3).
I et klinisk studie med raske forsøgspersoner steg serumkoncentrationerne af tizanidin, når det blev givet samtidigt med ciprofloxacin (Cmax øges gennemsnitligt 7 fold, område:
In a clinical study with healthy subjects, there was an increase in serum tizanidine concentration (Cmax increase:
4- 21 fold.
7-fold, range:
AUC øges gennemsnitligt 10 fold, område:
4 to 21-fold; AUC increase:
6- 24 fold).
10-fold, range:
29 Methotrexat
Methotrexate
Det kan medføre forhøjede plasmakoncentrationer af methotrexat og øge risikoen for methotrexat - betingede toksiske reaktioner.
Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions.
4. 4).
The concomitant use is not recommended (see section 4.4).
Samtidig indgift af ciprofloxacin og teofyllin kan forårsage en uønsket stigning i serumkoncentrationen af teofyllin.
28 Concurrent administration of ciprofloxacin and theophylline can cause an undesirable increase in serum theophylline concentration.
4. 4).
During the combination, serum theophylline concentrations should be checked and the theophylline dose reduced as necessary (see section 4.4).
Ved samtidig indgift af ciprofloxacin og koffein eller pentoxifyllin (oxpentifyllin) er der beskrevet forhøjede serumkoncentrationer af disse xanthinderivativer.
On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Phenytoin
Phenytoin
Derfor bør plasmakoncentrationerne af lægemidlet monitoreres.
Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
Der er set et stort antal tilfælde med stigninger i oral antikoagulant- aktivitet hos patienter, som har fået antibakterielle midler, herunder fluoroquinoloner.
There have been many reports of increases in oral anticoagulant activity in patients receiving antibacterial agents, including fluoroquinolones.
60% og 84%.
It was shown in a clinical study that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively.
4. 4).
Monitoring of ropinirole-related side effects and dose adjustment as appropriate is recommended during and shortly after co-administration with ciprofloxacin (see section 4.4).
29% og 31%.
Following concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively.
4. 4).
Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after co- administration with ciprofloxacin are advised (see section 4.4).