natgillin/translations-raw huggingface dataset:
Graviditet De oplysninger, der er tilgængelige vedrørende indgift af ciprofloxacin til gravide kvinder, tyder ikke på misdannelser eller foetotoksicitet hhv. neonatal toksicitet efter ciprofloxacin.
Pregnancy The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/ neonatal toxicity of ciprofloxacin.
5. 3).
In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism / foetus (see section 5.3).
30 Amning Ciprofloxacin udskilles i modermælk.
Lactation Ciprofloxacin is excreted in breast milk.
Ciprofloxacin bør ikke anvendes under amning på grund af den potentielle risiko for bindevævsskader.
Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.
Ciprofloxacin kan påvirke reaktionstiden på grund af dets neurologiske virkninger.
29 Due to its neurological effects, ciprofloxacin may affect reaction time.
Bivirkningerne er sorteret efter hyppighed.
ADRs derived from clinical studies and post-marketing surveillance with Ciprofloxacin Bayer (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below.
Organklasse
System Organ
Ukendt
Frequency
≥ 1/ 100 til <
≥ 1/ 100
≥ 1/ 1. 000 til
≥ 1/ 1 000 to <
≥ 1/ 10. 000 til <
≥ 1/ 10 000 to <
sjælden
to < 1/ 10
< 1/ 100
1/ 100
1/ 1. 000
1/ 1 000
< 1/ 10. 000
(cannot be estimated from available data)
beregnes fra de foreliggende data) Infektioner og parasitære sygdomme
Infections and Infestations
4. 4)
Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
Leukopeni Anæmi Neutropeni Leukocytose Trombocytopeni Trombocytæmi
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
Hæmolytisk anæmi Agranulocyto - se Pancytopeni (livstruende) Knoglemarvs - depression (livstruende)
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
Forstyrrelser i immun - systemet
Immune System Disorders
4. 4) Serumsyg - domslignende reaktion
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness- like reaction
Konfusion og desorientering Angst Abnorme drømme Depression Hallucinationer
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
4. 4)
Psychotic reactions (see section 4.4)
Organklasse
30 System Organ
beregnes fra de foreliggende data) systemet
Nervous System Disorders
Svimmelhed Søvnforstyrrelser Smagsforstyrrel - ser
Headache Dizziness Sleep disorders Taste disorders
4. 4) Vertigo
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Koordinations - forstyrrelser Gangforstyr - relser Olfaktoriske nervesyg - domme Intrakraniel hypertension
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
4. 4)
Peripheral neuropathy (see section 4.4)
Synsforstyrrelser
Eye Disorders Ear and Labyrinth Disorders
Forvrænget farvesyn
Visual disturbances Tinnitus Hearing loss / Hearing impaired
Øre og labyrint
Visual colour distortions
Tinnitus Tab af hørelse / nedsat hørelse
Cardiac Disorders
Ventrikulær arytmi QT - forlængelse Torsades de pointes *
Ventricular arrhythmia, QT prolongation, torsades de pointes *
Vasculitis
Vasculitis
Gastrointesti - nale sygdom - me
Gastrointestinal Disorders
Opkastning Mave - og abdominalsmerter Dyspepsi Flatulens
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
Nedsat leverfunktion Gulsot Hepatitis
Hepatic impairment Cholestatic icterus Hepatitis
4. 4)
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
Organklasse
31 System Organ
hyppihed
1/ 100
1/ 10
1/ 1 000
< 1/ 100
(cannot be estimated from available data)
1/ 1. 000
Skin and Subcutaneous Tissue Disorders
< 1/ 10. 000
Rash Pruritus Urticaria
(kan ikke
Photosensitivity reactions (see section 4.4)
beregnes fra de foreliggende data) nekrolyse (potentielt livstruende) Knogler, led, muskler og bindevæv
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
Muskel - og skeletsmerter (f. eks. ekstremitetssmer - ter, rygsmerter og brystsmerter) Artralgier
Musculoskeletal, Connective Tissue and Bone Disorders
Myalgier Artritis Øget muskeltonus og muskelkramper
Musculoskeletal pain (e. g. extremity pain, back pain, chest pain) Arthralgia
Muskelsvag - hed Tendinitis Seneruptur (fortrinsvis akillessenen) (se pkt.
Myalgia Arthritis Increased muscle tone and cramping
4. 4)
Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
4. 4) Tubulointerstitiel nephritis
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
Asteni Feber
Asthenia Fever
Under - søgelser
Investigations
Abnormt protrombinniveau Øget amylase
Prothrombin level abnormal Increased amylase
4. 4)
* These events were reported during the postmarketing period and were observed predominantly among patients with further risk factors for QT prolongation (see section 4.4).
Børn Hyppigheden af ovennævnte artropati refererer til data, som stammer fra studier hos voksne.
Paediatric patients The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults.
4. 4).
In children, arthropathy is reported to occur commonly (see section 4.4).
Det er indberettet, at en overdosis på 12 g har medført lette toksiske symptomer.
32 An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Symptomerne på overdosering omfatter: svimmelhed, tremor, hovedpine, træthed, krampeanfald, hallucinationer, konfusion, maveubehag, nedsat nyre - og leverfunktion samt krystalluri og hæmaturi.
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.
Det er kun en mindre mængde ciprofloxacin (< 10%), der elimineres ved hæmodialyse eller peritonealdialyse.
Only a small quantity of ciprofloxacin (< 10%) is eliminated by haemodialysis or peritoneal dialysis.
Fluoroquinolon, ATC- kode:
Fluoroquinolones, ATC code:
J01 MA 02.
J01MA02
Som et fluorquinolon- antibiotikum udøver Ciprofloxacin sin baktericide virkning ved at hæmme både type II topo- isomerase (DNA- gyrase) og top- isomerase IV, som er nødvendig for bakteriel DNA - replikation, transskription, genopretning og rekombination.
As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.
PK/ PD- forholdet:
PK/ PD relationship:
Resistens:
Mechanism of resistance:
In vitro- resistens over for ciprofloxacin kan erhverves gennem en trinvis proces af mutationer på målstedet af både topoisomerase II, DNA gyrase og topoisomerase IV.
In-vitro resistance to ciprofloxacin can be acquired through a stepwise process by target site mutations in both DNA gyrase and topoisomerase IV.
Impermeabilitet og/ eller resistens, som påvirker mekanismen af efflukspumpen for den aktive substans, kan have forskellig virkning på følsomheden over for fluoroquinoloner, hvilket afhænger af de fysiokemiske egenskaber hos forskellige aktive substanser inden for klassen og affiniteten af transportsystemerne for hver aktiv substans.
Impermeability and/ or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance.
Alle in vitro- mekanismer for resistens ses almindeligvis i kliniske isolater.
All in-vitro mechanisms of resistance are commonly observed in clinical isolates.
Resistensmekanismer, som inaktiverer andre antibiotika, som f. eks. permeationsbarrierer (almindelig hos Pseudomonas aeruginosa) og effluksmekanismer, kan påvirke følsomheden over for ciprofloxacin.
Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to ciprofloxacin.
Der er set plasmidmedieret resistens kodet via qnr- gener.
Plasmid-mediated resistance encoded by qnr-genes has been reported.
EUCAST- rekommendationer
EUCAST Recommendations
Haemophilus influenzae og Moraxella catarrhalis
33 Haemophilus influenzae and Moraxella catarrhalis
Neisseria gonorrhoeae Neisseria meningitidis Ikke- artsrelaterede breakpoints *
Neisseria gonorrhoeae Neisseria meningitidis Non-species-related breakpoints*
S ≤ 0, 03 mg/ l S ≤ 0, 03 mg / S ≤ 0, 5 mg/ l
S ≤ 0.03 mg/ L S ≤ 0.03 mg/ L S ≤ 0.5 mg/ L
R > 0, 06 mg / R > 0, 06 mg / R > 1 mg/ l
> 0.06 mg/ L > 0.06 mg/ L R > 1 mg/ L
34 * Ikke- artsrelaterede breakpoints er primært blevet bestemt på grundlag af PK/ PD- data, og er uafhængige af fordelingerne af MIC for specifikke arter.
1 Staphylococcus spp. - breakpoints for ciprofloxacin relate to high dose therapy. * Non-species-related breakpoints have been determined mainly on the basis of PK/ PD data and are independent of MIC distributions of specific species.
De skal kun bruges for arter, som ikke har fået et arts- specifikt breakpoint, og ikke for de arter, hvor testning af følsomhed ikke anbefales.
They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended.
ALMINDELIGE FØLSOMME ARTER Aerobe grampositive mikroorganismer Bacillus anthracis (1) Aerobe gramnegative mikroorganismer Aeromonas spp.
Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4) COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
Yersinia pestis Anaerobe mikroorganismer Mobiluncus Andre mikroorganismer Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) ARTER, HVOR ERHVERVET RESISTENS KAN VÆRE ET PROBLEM Aerobe grampositive mikroorganismer Enterococcus faecalis ($) Staphylococcus spp. * (2) Aerobe gramnegative mikroorganismer Acinetobacter baumannii+ Burkholderia cepacia+ * Campylobacter spp. + * Citrobacter freundii * Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorrhoeae * Proteus mirabilis * Proteus vulgaris * Providencia spp.
Yersinia pestis Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms Enterococcus faecalis ($) Staphylococcus spp. * (2) Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia+* Campylobacter spp. +* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae* Escherichia coli* Klebsiella oxytoca
Pseudomonas aeruginosa * Pseudomonas fluorescens Serratia marcescens * Anaerobe mikroorganismer Peptostreptococcus spp.
Pseudomonas aeruginosa* Pseudomonas fluorescens Serratia marcescens* Anaerobic micro-organisms Peptostreptococcus spp.
Propionibacterium acnes ORGANISMER MED NATURLIG RESISTENS Aerobe grampositive mikroorganismer Actinomyces
Propionibacterium acnes INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia
36 Enteroccus faecium Listeria monocytogenes Aerobe gramnegative mikroorganismer Stenotrophomonas maltophilia Anaerobe mikroorganismer Undtagen ovennævnte Andre mikroorganismer Mycoplasma genitalium Ureaplasma urealitycum * Der er dokumenteret klinisk effekt for følsomme isolater ved godkendte indikationer + Resistensgrad ≥ 50% i et eller flere EU- lande ($):
35 Anaerobic micro-organisms Excepted as listed above Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications + Resistance rate ≥ 50% in one or more EU countries ($):
Naturlig intermediær følsomhed i fravær af erhvervet resistensmekanisme (1):
Natural intermediate susceptibility in the absence of acquired mechanism of resistance (1):
Der er foretaget studier ved eksperimentelle infektioner hos dyr efter inhalation af Bacillus anthracis sporer; disse studier viser, at tidlig antibiotikabehandling efter eksponering, kan forhindre sygdommen, hvis behandlingen tilpasses til at mindske antallet af sporer i organismen med den infektive dosis.
Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose.
Den anbefalede dosis til mennesker er primært baseret på in vitro- følsomhed og på dyreeksperimentelle data sammen med begrænsede humane data.
The recommended use in human subjects is based primarily on in-vitro susceptibility and on animal experimental data together with limited human data.
To måneders behandling af voksne med oral ciprofloxacin i en dosis på 500 mg to gange dagligt anses dog for effektiv til at forebygge anthraxinfektioner hos mennesker.
Two-month treatment duration in adults with oral ciprofloxacin given at the following dose, 500 mg bid, is considered as effective to prevent anthrax infection in humans.
Den behandlende læge henvises til nationale og/ eller internationale konsensusdokumenter vedrørende behandling af anthrax.
The treating physician should refer to national and/ or international consensus documents regarding treatment of anthrax.
Methicillinresistente S. aureus viser meget hyppigt samme resistens over for fluoroquinoloner.
Methicillin-resistant S. aureus very commonly express co-resistance to fluoroquinolones.
Den maksimale serumkoncentration nås efter 1- 2 timer.
Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.
Efter enkeltdoser på 100- 750 mg blev der nået dosisafhængige maksimale serumkoncentrationer (Cmax) mellem 0, 56 og 3, 7 mg/ l.
Single doses of 100-750 mg produced dose-dependent maximum serum concentrations (Cmax) between 0.56 and 3.7 mg/ L.
70- 80%.
The absolute bioavailability is approximately 70-80%.
Ciprofloxacin har en lav proteinbinding (20- 30%).
Protein binding of ciprofloxacin is low (20-30%).
Ciprofloxacin findes overvejende uioniseret i plasma og har i steadystate et stort distributionsvolumen på 2- 3 l/ kg legemsvægt.
Ciprofloxacin is present in plasma largely in a non- ionised form and has a large steady state distribution volume of 2-3 L/ kg body weight.
Ciprofloxacin når høje koncentrationer i mange væv som f. eks. lungevæv (epitelvæske, alveolære makrofager, biopsivæv), bihuler og inflammerede læsioner (cantharides blistervæske) og urogenitalsystemet (urin, prostata, endometrium), hvor totalkoncentrationerne kan overstige plasmakoncentrationerne.
Ciprofloxacin reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.
37 Ciprofloxacin er kendt for at være en moderat hæmmer af CYP 450 1A2- iso- enzymer.
Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.
4 – 7 timer hos patienter med normal nyrefunktion.
The serum elimination half-life in subjects with normal renal function is approximately 4-7 hours.
Udskillelse af ciprofloxacin (% af dosis) Oral indgift
36 Excretion of ciprofloxacin (% of dose) Oral Administration
Fæces
Faeces
Ciprofloxacin Metaboliter (M1- M4)
Ciprofloxacin Metabolites (M1-M4)
Den renale clearance er på 180 og 300 ml/ kg/ time og den totale bodyclearance er mellem 480 og 600 ml/ kg/ time.
Renal clearance is between 180-300 mL/ kg/ h and the total body clearance is between 480-600 mL/ kg/ h.
Ciprofloxacins non- renale clearance sker primært ved aktiv transintestinal sekretion og ved metabolisering.
Non-renal clearance of ciprofloxacin is mainly due to active trans-intestinal secretion and metabolism.
Én procent af den indgivne dosis udskilles med galden, hvor koncentrationen er høj.
Ciprofloxacin is present in the bile in high concentrations.
Der blev ikke set nogen bemærkelsesværdig stigning i Cmax og AUC efter gentagen dosering (10 mg/ kg tre gange dagligt).
No notable increase in Cmax and AUC upon multiple dosing (10 mg/ kg three times daily) was observed.
Hos 10 børn med svær sepsis var Cmax 6, 1 mg/ l (område 4, 6- 8, 3 mg/ L) efter en 1- times intravenøs infusion i en dosis på 10 mg/ kg hos børn under 1 år sammenlignet med 7, 2 mg/ l (område 4, 7- 11, 8 mg/ l) hos børn mellem 1 og 5 år.
In 10 children with severe sepsis Cmax was 6.1 mg/ L (range 4.6-8.3 mg/ L) after a 1-hour intravenous infusion of 10 mg/ kg in children aged less than 1 year compared to 7.2 mg/ L (range 4.7-11.8 mg/ L) for children between 1 and 5 years of age.
17, 4 mg* h/ l (område 11, 8- 32, 0 mg* h/ l) og 16, 5 mg* h/ l (område 11, 0- 23, 8 mg* h/ l) i de respektive aldersgrupper.
The AUC values were 17.4 mg*h/ L (range 11.8-32.0 mg*h/ L) and 16.5 mg*h/ L (range 11.0-23.8 mg*h/ L) in the respective age groups.
Baseret på populationsfarmakokinetiske analyser er den forventede gennemsnitlige halveringstid hos børn med forskellige infektioner ca.
Based on population pharmacokinetic analysis of paediatric patients with various infections, the predicted mean half-life in children is approx.
4- 5 timer, og biotilgængeligheden af den orale suspension er mellem 50 og 80%.
4-5 hours and the bioavailability of the oral suspension ranges from 50 to 80%.
Data om fotomutagenicitet/ fotocarcinogenicitet viser en svag fotomutagen eller fototumorigen virkning af ciprofloxacin in vitro og i dyreforsøg.
Data on photomutagenicity/ photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments.
Artikulær tolerance:
Articular tolerability:
Skaderne kan nedsættes ved at fjerne vægten fra ledene.
The extent of the cartilage damage varies according to age, species and dose; the damage can be reduced by taking the weight off the joints.
I et studie med unge beagle - hunde forårsagede ciprofloxacin alvorlige forandringer i leddene ved terapeutiske doser efter 2 ugers behandling, som stadig blev observeret efter 5 måneder.
In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.
[Udfyldes nationalt]
37 [To be completed nationally]
[Se bilag I - Udfyldes nationalt]
[See Annex I - To be completed nationally.]
{Navn og adresse} < {Tlf} > < {Fax} > < {Email} >
{Name and address }< {tel }> < {fax }> < {e-mail }>
[Udfyldes nationalt}
[To be completed nationally.]
[MM/ ÅÅÅÅ]
{MM/ YYYY}
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 250 mg filmovertrukne tabletter [Se bilag I – Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally]
4. 4 og 5. 1).
Ciprofloxacin Bayer 250 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
40 • Infektioner i hud og bløddele forårsaget af gramnegative bakterier
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Malign ekstern otitis
39 • Malignant external otitis
500 mg som éngangsdosis
41 Indications
Inhalationsanthrax,
Inhalation anthrax
10 mg/ kg op til 15 mg/ kg legemsvægt to gange
10 mg/ kg body weight twice daily to 15 mg/ kg body
60 dage
60
efter bekræftelse
days from the
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.
dagligt, maksimalt 500 mg pr. dosis.
weight twice daily with a maximum of 500 mg per dose.
af eksponering for Bacillus anthracis
confirmation of Bacillus anthracis exposure
Nedsat nyre - og leverfunktion
Renal and hepatic impairment
124
124 to 168
250- 500 mg hver 12. time
250-500 mg every 12 h
250- 500 mg hver 24. time (efter dialyse)
250-500 mg every 24 h (after dialysis)
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.
44 Rejsediaré Ved valget af ciprofloxacin skal der tages hensyn til resistensen over for ciprofloxacin hos relevante patogener i de lande, der besøges.
43 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.
Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
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.
45 Allerede 48 timer efter start af behandlingen med ciprofloxacin kan der forekomme tendinitis og seneruptur (specielt af akillessenen), af og til bilateralt.
44 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
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.
46 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).
45 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- 21 fold; AUC øges gennemsnitligt 10 fold, område:
4 to 21-fold; AUC increase:
47 Methotrexat
Methotrexate
Teofyllin
46 Theophylline
48 Amning Ciprofloxacin udskilles i modermælk.
Lactation Ciprofloxacin is excreted in breast milk.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
47 4.7 Effects on ability to drive and use machines
49 Organklasse
48 System Organ
beregnes fra de foreliggende data) Nerve - systemet
Nervous System Disorders
Hovedpine Svimmelhed Søvnforstyrrelser Smagsforstyrrel - ser
Headache Dizziness Sleep disorders Taste disorders
Migræne Koordinations - forstyrrelser Gangforstyr - relser Olfaktoriske nervesyg - domme Intrakraniel hypertension
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension