natgillin/translations-raw huggingface dataset:
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
Any unused solution should be disposed off.
{Navn og adresse} < {Tlf} > < {Fax} > < {Email} >
{Name and address} < {tel} > < {fax} > < {e-mail} >
[Udfyldes nationalt}
[To be completed nationally]
190 10.
10.
[MM/ ÅÅÅÅ]
{MM/YYYY}
191 1.
186 1.
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 400 mg/ 200 ml infusionsvæske, opløsning [Se bilag I – Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloxacin Bayer 400 mg/ 200 ml infusionsvæske, opløsning er indiceret til behandling af følgende infektioner (se pkt.
Ciprofloxacin Bayer 400 mg/200 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
• Gastrointestinale infektioner (f. eks. rejsediaré)
• Infections of the gastro-intestinal tract (e.g. travellers` diarrhoea)
192 • Infektioner i hud og bløddele forårsaget af gramnegative bakterier
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Infektioner i knogler og led
187 • Infections of the bones and joints
4. 4 og 5. 1).
Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).
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.
Behandling af infektioner, der skyldes visse bakterier (f. eks.
Treatment of infections due to certain bacteria (e.g.
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.
193 Voksne
Adults
Epididymoorchitis og
Epididymo-orchitis and pelvic inflamm atory diseases
194 Indikationer
400 mg twice daily 400 mg twice daily to 400 mg three times a day
10 mg/ kg legemsvægt tre gange dagligt, maksimalt 400 mg pr. dosis.
10 mg/kg body weight three times a day with a maximum of 400 mg per dose.
6 mg/ kg tre gange dagligt op til 10 mg/ kg legemsvægt tre gange dagligt, maksimalt 400 mg pr. dosis.
6 mg/kg body weight three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose.
10 mg/ kg to gange dagligt op til 15 mg/ kg
10 mg/kg body weight twice daily to 15 mg/kg body
195 Nedsat nyre - og leverfunktion
Renal and hepatic impairment
Kreatininclearance [ml/ min / 1, 73 m²]
Creatinine Clearance [mL/min/1.73 m²]
Serumkreatinin [µmol/ l]
Serum Creatinine [µmol/L]
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.
Indgivelsesmåde
190 Method of administration
196 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.
Det er vist, at ciprofloxacin kan forårsage artropati i de vægtbærende led hos ikke fuldtudvoksede dyr.
191 Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals.
197 Det muskuloskeletale system Ciprofloxacin bør generelt ikke bruges til patienter, som har haft senesygdomme relateret til behandling med quinoloner. ciprofloxacin kan dog i meget sjældne tilfælde ordineres til behandling af visse alvorlige infektioner efter mikrobiologisk dokumentation af den kausale organisme og en vurdering af risici og fordele.
Musculoskeletal System Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment.
Hvis der forekommer krampeanfald, skal ciprofloxacin seponeres (se pkt 4. 8).
If seizures occur Ciprofloxacin should be discontinued (see section 4.8).
Der kan forekomme psykiske reaktioner selv efter første indgift af ciprofloxacin.
Psychiatric reactions may occur even after the
I sjældne tilfælde kan en depression eller psykose udvikle sig således, at patienter bliver til fare for sig selv.
In rare cases, depression or psychosis can progress to self- endangering behaviour.
I disse tilfælde skal ciprofloxacin seponeres, og lægen skal omgående informeres.
In these cases, ciprofloxacin should be discontinued.
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).
198 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.
Reaktioner på injektionstedet Der er indberetninger om lokale reaktioner på injektionsstedet efter intravenøs indgift af ciprofloxacin.
193 Injection Site Reaction Local intravenous site reactions have been reported with the intravenous administration of ciprofloxacin.
Glucosebelastning Ciprofloxacin infusionsopløsning indeholder 10 g glucose i 200 ml opløsning til infusion.
Glucose Load Ciprofloxacin Bayer solution for infusion contains 10 g glucose in 200 mL solution for infusion.
199 Methotrexat
Methotrexate
Risikoen varierer med den tilgrundliggende infektion, alder og patienternes almentilstand.
The risk may vary with the underlying infection, age
Det er derfor svært at vurdere fluoroquinolons bidrag til stigningen i INR (international normaliseret ratio).
194 and general status of the patient so that the contribution of the fluoroquinolone to the increase in INR (international normalised ratio) is difficult to assess.
200 Amning Ciprofloxacin udskilles i modermælk.
Lactation Ciprofloxacin is excreted in breast milk.
Organklasse
195 System Organ Class
≥ 1/ 100 til <
Uncommon ≥ 1/1 000 to <
≥ 1/ 10. 000 til <
Rare ≥ 1/10 000 to <
sjælden
Very Rare < 1/ 10 000
hyppihed
Frequency not known
< 1/ 100
1/100
1/ 1. 000
1/1 000
201
Nervous System Disorders
Organklasse
Headache Dizziness Sleep disorders Taste disorders
Almindelig
Peripheral neuropathy (see section 4.4)
Ikke almindelig
Eye Disorders Ear and Labyrinth Disorders
Sjælden
Visual disturbances Tinnitus Hearing loss / Hearing impaired
Meget
Visual colour distortions
Ukendt
196 System Organ Class
≥ 1/ 100 til <
Common ≥ 1/100 to <
≥ 1/ 1. 000 til
Uncommon ≥ 1/1 000 to <
beregnes fra de foreliggende data) Nerve - systemet
(cannot be estimated from available data)
Vasodilatation Hypotension Synkope
Vasodilation Hypotension Syncope
Organklasse
197 System Organ Class
Almindelig ≥ 1/ 100 til <
Common ≥ 1/100 to <
Ikke almindelig ≥ 1/ 1. 000 til
Uncommon ≥ 1/1 000 to <
Sjælden ≥ 1/ 10. 000 til
Rare ≥ 1/10 000 to <
Meget < sjælden
Very Rare < 1/ 10 000
Ukendt hyppihed
Frequency not known
beregnes fra de foreliggende data) epidermal nekrolyse (potentielt livstruende) Knogler, led, muskler og bindevæv
Musculoskeletal, Connective Tissue and Bone Disorders
Muskel - og skeletsmerter (f. eks. ekstremitetssmer - ter, rygsmerter og brystsmerter) Artralgier
Musculoskeletal pain (e.g. extremity pain, back pain, chest pain) Arthralgia
203 Børn Hyppigheden af ovennævnte artropati refererer til data, som stammer fra studier hos voksne.
The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults.
Det er indberettet, at en overdosis på 12 g har medført lette toksiske symptomer.
198 An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
204 Antibakterielt spektrum:
Spectrum of antibacterial activity:
Haemophilus influenzae og Moraxella catarrhalis
199 Haemophilus influenzae and Moraxella catarrhalis
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.
200 Aerobic Gram-negative micro-organisms 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.
Efter en intravenøs infusion af ciprofloxacin opnås den gennemsnitlige maksimumserumkoncentration ved slutningen af infusionen.
201 Following an intravenous infusion of ciprofloxacin the mean maximum serum concentrations were achieved at the end of infusion.
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.
207 Metabolisme
Metabolism
De foreliggende data om farmakokinetikken hos børn er begrænsede.
202 The pharmacokinetic data in paediatric patients are limited.
208 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.
Da infusionsopløsningen er lysfølsom, skal infusionsposerne tages ud af pakningen umiddelbart før brugen.
203 Since the infusion solution is photosensitive, the infusion bags should be removed from the box only immediately before use.
210 1.
204 1.
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 100 mg/ 50 ml infusionsvæske, opløsning [Se bilag I – Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/50 mL solution for infusion [See Annex I - To be completed nationally]
4. 4 og 5. 1).
Ciprofloxacin Bayer 100 mg/50 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
211 • Infektioner i hud og bløddele forårsaget af gramnegative bakterier
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Infektioner i knogler og led
205 • Infections of the bones and joints
212 Voksne
Adults
behandling så hurtigt som muligt) Infektioner i de nedre luftveje
Infections of the lower respiratory tract
(iht. sværhedsgrad og
206 Indications
dagligt op til 400 mg tre gange dagligt
Total duration of treatment (including switch to oral therapy as soon as possible)
ukompliceret
Complicated and uncomplicated pyelonephritis
tre gange dagligt
400 mg twice daily to 400 mg three times a day
end 21 dage (fx ved abscesser)
7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)
2- 4 uger (akut)
2
infektioner, som skyldes gramnegative bakterier
Diarrhoea caused by Vibrio cholerae
dagligt op til 400 mg tre gange dagligt
400 mg twice daily
Infektioner i hud og bløddele
Typhoid fever Intra-abdominal infections due to Gram-negative bacteria
400 mg to gange
400 mg twice daily 400 mg twice daily to 400 mg three times a day
7- 14 dage
7 days 5 to 14 days
dagligt op til 400 mg tre gange dagligt
Infections of the skin and soft tissue
213 Indikationer
400 mg twice daily to 400 mg three times a day
Daglig dosis
7 to 14 days
behandling så hurtigt som muligt) Infektioner i knogler og led
Bone and joint infections
dagligt op til 400 mg tre gange dagligt Behandling af infektioner eller profylakse
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.
Behandlingen bør fortsættes i
Therapy should be continued over the entire period of neutropenia
over for infektioner hos patienter med neutropeni Ciprofloxacin skal gives sammen med andre antibakterielle stoffer i henhold til officielle retningslinjer.
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons requiring parenteral treatment Drug administration should begin as soon
dagligt op til 400 mg tre gange dagligt
400
hele neutropeniperioden
mg twice daily
Behandlingen skal begynde så hurtigt som muligt efter mistanke om eller bekræftet eksponering.
60 days from the confirmation of Bacillus anthracis exposure
400
207
60 dage efter bekræftelse af eksponering for Bacillus anthracis
Total duration of treatment (including switch to oral therapy as soon as possible)
214 Nedsat nyre - og leverfunktion
Renal and hepatic impairment
Kreatininclearance [ml/ min / 1, 73m²]
Creatinine Clearance [mL/min/ 1.73 m²]
Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion.
208 In patients with impaired liver function no dose adjustment is required.
215 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.
Børn og unge Anvendelsen af ciprofloxacin til børn og unge skal ske i henhold til tilgængelig officiel vejledning.
209 Children and adolescents The use of ciprofloxacin in children and adolescents should follow available official guidance.
216 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.
Centralnervesystemet Quinoloner er kendt for at kunne udløse krampeanfald eller sænke krampetærsklen.
210 Central Nervous System Quinolones are known to trigger seizures or lower the seizure threshold.
217 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.
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.
211 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.
2 vedrørende natriumindholdet).
NaCl Load In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.), the additional sodium load should be taken into account (for sodium chloride content, see section 2).
Virkningen af ciprofloxacin på andre lægemidler:
Effects of Ciprofloxacin on other medicinal products:
4. 3).
Tizanidine must not be administered together with Ciprofloxacin (see section 4.3).
218 Methotrexat
Methotrexate
Samtidig indgift af ciprofloxacin og teofyllin kan forårsage en uønsket stigning i serumkoncentrationen af teofyllin.
Concurrent administration of Ciprofloxacin and theophylline can cause an undesirable increase in serum theophylline concentration.
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.
Orale antikoagulantia
212 Oral anticoagulants
219 Amning Ciprofloxacin udskilles i modermælk.
Lactation Ciprofloxacin is excreted in breast milk.
Organklasse
213 System Organ Class
Almindelig
Common ≥ 1/100 to < 1/10
≥ 1/ 100 til <
Uncommon ≥ 1/1 000 to < 1/100
≥ 1/ 10. 000 til <
Rare ≥ 1/10 000 to < 1/1 000
< 1/ 10. 000
Very Rare < 1/10 000
(kan ikke
Frequency not known (cannot be estimated from available data)
Mykotiske superinfektioner
Mycotic superinfection s
Leukopeni Anæmi Neutropeni Leukocytose Trombocytopeni Trombocytæmi
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopen ia Thrombocytaemi a
Hæmolytisk anæmi Agranulocyto - se Pancytopeni (livstruende) Knoglemarvs - depression (livstruende)
Haemolytic anaemia Agranulocyt osis Pancytopeni a (life- threatening) Bone marrow depression (life- threatening)
4. 4) Serumsyg - domslignende reaktion
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness-like reaction
Organklasse
Nervous System Disorders
Ikke almindelig
Headache Dizziness Sleep disorders Taste disorders
Sjælden
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Meget
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
≥ 1/ 100 til <
Peripheral neuropathy (see section 4.4)
≥ 1/ 1. 000 til
214 System Organ Class
≥ 1/ 10. 000 til <
Common ≥ 1/100 to < 1/10
< 1/ 100
Uncommon ≥ 1/1 000 to < 1/100
1/ 1. 000
Rare ≥ 1/10 000 to < 1/1 000
beregnes fra de foreliggende data) Nerve - systemet
Frequency not known (cannot be estimated from available data)
4. 4) Vertigo
Eye Disorders
Migræne Koordinations - forstyrrelser Gangforstyr - relser Olfaktoriske nervesyg - domme Intrakraniel hypertension
Visual disturbances
Perifer neuropati (se pkt.
Visual colour distortions
Synsforstyrrelser
Ear and Labyrinth Disorders
Forvrænget farvesyn
Tinnitus Hearing loss / Hearing impaired
Gastrointesti - nale sygdom - me
Gastrointestin al Disorders
Opkastning Mave - og abdominalsmerter Dyspepsi Flatulens
Vomiting Gastrointestin al and abdominal pains Dyspepsia Flatulence
4. 4)
Liver necrosis (very rarely progressing to life- threatening hepatic failure) (see section 4.4)
Organklasse
215 System Organ Class
Almindelig ≥ 1/ 100 til <
Common ≥ 1/100 to < 1/10
Ikke almindelig ≥ 1/ 1. 000 til
Uncommon ≥ 1/1 000 to < 1/100
Sjælden ≥ 1/ 10. 000 til
Rare ≥ 1/10 000 to < 1/1 000
Meget < sjælden
Very Rare < 1/10 000
Ukendt hyppihed
Frequency not known (cannot be estimated from available data)
1/ 10
Skin and Subcutaneous Tissue Disorders
Muskel - og skeletsmerter (f. eks. ekstremitetssmer - ter, rygsmerter og brystsmerter) Artralgier
Musculoskelet al, Connective Tissue and Bone Disorders
Myalgier Artritis Øget muskeltonus og muskelkramper
Musculoskelet al pain (e.g. extremity pain, back pain, chest pain) Arthralgia
4. 4)
Muscular weakness Tendinitis Tendon rupture (predominan tly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Følgende bivirkninger forekommer hyppigere hos de patienter, som får intravenøs eller sekventiel behandling (intravenøs og oral):
216 The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment:
222 4. 9 Overdosering
4.9 Overdose
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.
217 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.
223 EUCAST- rekommendationer
EUCAST Recommendations
Staphylococcus spp. - breakpoints for ciprofloxacin refererer til højdosisbehandling. * 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.
225 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 ($):
219 Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia 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 ($):
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.
220 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.
226 Metabolisme
Metabolism
Ciprofloxacin udskilles overvejende uændret, både renalt og i mindre grad fækalt.
Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally.–
Artikulær tolerance:
221 Articular tolerability:
227 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.
For at lette brugen, skal gummiproppen på infusionshætteglasset penetreres i den centrale ring.
For ease of use the infusion vial stopper should be penetrated in the central ring.
Penetration af den ydre ring kan beskadige gummiproppen på hætteglasset
Penetration of the outer ring may result in damage to the vial stopper.
[Udfyldes nationalt}
222 [To be completed nationally]
228 10.
10.
229 1.
223 1.
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 200 mg/ 100 ml infusionsvæske, opløsning [Se bilag I – Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally]
4. 4 og 5. 1).
Ciprofloxacin Bayer 200 mg/100 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
230 • Infektioner i hud og bløddele forårsaget af gramnegative bakterier
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Infektioner i knogler og led
224 • Infections of the bones and joints
231 Voksne
Adults