natgillin/translations-raw huggingface dataset:
Ciproxin
250 mg 500 mg 750 mg 200 mg/ 100 ml 400 mg/ 200 ml
750 mg
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion
filmovertrukne tabletter
oral use oral use oral use intravenous use intravenous use
oral anvendelse
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml
750 mg
Poland
Bayer plc, Bayer Schering Pharma
Bayer HealthCare AG Ciprobay Uro D-51368 Leverkusen Ciprobay Germany Ciprobay Ciprobay Ciprobay Ciprobay
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
100 mg 250 mg 500 mg 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
suspension suspension infusionsvæske, opløsning infusionsvæske, opløsning infusionsvæske, opløsning
film-coated tablet film-coated tablet film-coated tablet solution for infusion solution for infusion solution for infusion
oral anvendelse oral anvendelse intravenøs anvendelse intravenøs anvendelse intravenøs anvendelse
oral use oral use oral use intravenous use intravenous use intravenous use
50mg/ ml 100mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
100 mg 250 mg 500 mg 2 mg/ ml 2 mg/ ml 2 mg/ ml
Tjekkiet
Portugal
Bayer HealthCare AG D- 513 68 Leverkusen
Bayer Portugal, S. A.
100 mg/ 50 ml
250 mg 500 mg 750 mg
infusionsvæske, opløsning
film-coated tablets film-coated tablets film-coated tablets
intravenøs anvendelse
oral use oral use oral use
Tyskland
250 mg 500 mg 750 mg
Ciprobay
Ciproxina OD Portugal
Ciprobay
Ciproxina OD Ciproxina Ciproxina Ciproxina
400 mg/ 200 ml
1000 mg 10 g/ 100 ml 5 g/ 100 ml 200 mg/ 100 ml
infusionsvæske, opløsning
modified release tablets oral suspension oral suspension solution for infusion
intravenøs anvendelse
oral use oral use oral use intravenous use
2 mg/ ml
1000 mg 100 mg/ ml 50 mg/ ml 2 mg / ml
8 Medlemsland
8 Member State
Ciprobay Uro Ciprobay Ciprobay Ciprobay
Ciproxina
100 mg 250 mg 500 mg 750 mg
400 mg/ 200 ml
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter
solution for infusion
oral anvendelse oral anvendelse oral anvendelse oral anvendelse
intravenous use
100 mg 250 mg 500 mg 750 mg
2 mg / ml
Tyskland
Romania
Bayer Vital GmbH D- 51368 Leverkusen Tyskland
Bayer HealthCare AG Ciprobay D-51368 Leverkusen Ciprobay Germany Ciprobay Ciprobay XR Ciprobay XR Ciproxin Ciproxin
100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml 100 mg 250 mg 500 mg 750 mg 5 g/ 100 ml 10 g/ 100 ml
500 mg 200 mg/ 100 ml 400 mg/ 200 ml 500 mg 1000 mg 5 g/ 100 ml 10 g/ 100 ml
infusionsvæske, opløsning infusionsvæske, opløsning infusionsvæske, opløsning filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter suspension suspension
film-coated tablets solution for infusion solution for infusion modified release tablets modified release tablets oral suspension oral suspension
intravenøs anvendelse intravenøs anvendelse intravenøs anvendelse oral anvendelse oral anvendelse oral anvendelse oral anvendelse oral anvendelse oral anvendelse
oral use intravenous use intravenous use oral use oral use oral use oral use
2 mg/ ml 2 mg/ ml 2 mg/ ml 100 mg 250 mg 500 mg 750 mg 50 mg / ml 100 mg / ml
500 mg 2 mg/ ml 2 mg/ ml 500 mg 1000 mg 50 mg/ ml 100 mg/ ml
Bayer Healthcare AG 51368 Leverkusen,
Slovak Republic
Ciprofloxacin ANTIBAC
Bayer HealthCare AG Ciprobay D-51368 Leverkusen
Ciprofloxacin ANTIBAC
Germany Ciprobay
Ciprofloxacin ANTIBAC
Ciprobay
Ciprofloxacin BAYER
Slovenia
100 mg/ 50 ml
250 mg 500 mg 750 mg 200 mg/ 100 ml 400 mg/ 200 ml
infusionsvæske, opløsning
film-coated tablet film-coated tablet film-coated tablet solution for infusion solution for infusion
intravenøs anvendelse
oral use oral use oral use intravenous use intravenous use
Ciprofloxacin BAYER
Baix Llobregat, 3-5
200 mg/ 100 ml
BAYCIP BAYCIP BAYCIP
infusionsvæske, opløsning
250 mg 500 mg 750 mg
2 mg/ ml
250 mg 500 mg 750 mg
9 Medlemsland
9 Member State
Ciprofloxacin BAYER
08970 Sant Joan Despí BAYCIP Barcelona
400 mg/ 200 ml
250 mg
infusionsvæske, opløsning
oral suspension (in single dose sachets)
2 mg/ ml
250 mg
Ciprofloxacin VITAL
Spain BAYCIP
Ciprofloxacin VITAL
BAYCIP
200 mg/ 100 ml
10 g/ 100 ml
infusionsvæske, opløsning
oral suspension
2 mg/ ml
100 mg/ ml
400 mg/ 200 ml
Sweden
infusionsvæske, opløsning
Bayer HealthCare AG Ciproxin D-51368 Leverkusen
Ungarn
250 mg
Bayer Hungária Kft.
film-coated tablet
250mg.
oral use
250 mg 500 mg 2 mg/ ml
250 mg
Ciprobay Ciprobay
Germany Ciproxin
200 mg/ 100 ml 400 mg/ 200 ml
500 mg
intravenøs anvendelse intravenøs anvendelse
film-coated tablet
2 mg/ ml 2 mg/ ml
oral use
Østrig
500 mg
Bayer Austria GmbH Herbststraße 6- 10 1160 Wien Østrig
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
Ciproxin Ciproxin Ciproxin
750 mg 5 g/ 100 ml 10 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter
film-coated tablet oral suspension oral suspension solution for infusion solution for infusion
oral anvendelse oral anvendelse oral anvendelse
oral use oral use oral use intravenous use intravenous use
250 mg 500 mg 750 mg
United Kingdom
Ciproxin Ciproxin Ciproxin Ciprofloxacine « BAYER »
Newbury Berkshire RG14 1JA
100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml 200 mg/ 100 ml
Ciproxin Ciproxin Ciproxin
infusionsvæske, opløsning infusionsvæske, opløsning infusionsvæske, opløsning infusionsvæske, opløsning
film-coated tablet film-coated tablet film-coated tablet
intravenøs anvendelse intravenøs anvendelse intravenøs anvendelse intravenøs anvendelse
oral use oral use oral use
2 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
100 mg 250 mg 500 mg
Ciprofloxacine « BAYER
United Kingdom
400 mg/ 200 ml
Ciproxin
infusionsvæske, opløsning
film-coated tablet
2 mg/ ml
750 mg
Ciproxin Ciproxin
Trading as:
5% 10%
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
suspension suspension
250 mg/ 5 ml 500 mg/ 5 ml 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
oral anvendelse oral anvendelse
oral use oral use intravenous use intravenous use intravenous use
5% 10%
50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
11 FAGLIGE KONKLUSIONER
11 SCIENTIFIC CONCLUSIONS
Ciprofloxacin er et bredspektret antibakterielt stof i fluoroquinolon- gruppen.
Ciprofloxacin is a broad spectrum antibacterial agent that belongs to the fluoroquinolone family.
Ciprofloxacin er godkendt til behandling af ukomplicerede og komplicerede infektioner forårsaget af ciprofloxacin- følsomme bakterier og dermed en lang række infektioner hos voksne.
Ciprofloxacin is approved for the treatment of uncomplicated and complicated infections caused by ciprofloxacin- susceptible bacteria and thus a broad variety of infections in adults.
Følgende perorale og intravenøse formuleringer er i øjeblikket godkendt og markedsføres i forskellige EU- lande:
The following oral and intravenous formulations are currently approved and marketed in different EU countries:
- Filmovertrukne tabletter med umiddelbar udløsning:
- Immediate release film-coated tablets:
- Granulater og solvens til peroral suspension:
- Granules and solvent for oral suspension:
- Infusionsvæske, opløsning (glasflasker og flexibags):
- Solution for infusion (glass bottles and flexibags):
100 mg/ 50 ml, 200 mg/ 100 ml og
100 mg/ 50 ml, 200 mg/ 100 ml and 400 mg/ 200 ml
- Filmovertrukne tabletter med modificeret udløsning:
- Modified release film-coated tablets:
500 mg, 1 000 mg
500 mg, 1000 mg.
- Poser:
- Sachets:
Produktresuméets afsnit 4. 1 Terapeutiske indikationer CHMP harmoniserede dette afsnit samlet set under særlig hensyntagen til den tilgængelige information om resistens over for ciprofloxacin for hver enkelt indikation.
SPC Section 4.1 Therapeutic Indications Overall, the CHMP harmonised this section, providing particular attention to the available information on resistance to ciprofloxacin for each indication.
Indikationer, der ikke længere er godkendt CHMP vurderede samlet set, at den terapeutiske indikation "akut sinuitis" ikke kunne accepteres, idet det mest almindelige patogen, der forårsager denne infektion, Streptococcus pneumoniae, kun er midlertidigt følsom over for ciprofloxacin, og stoffets virkning i denne indikation kun understøttes i ringe grad af de indsendte data.
Withdrawn Indications Overall, the CHMP considered that the therapeutic indication “ acute sinusitis” could not be accepted, as the most commonly involved pathogen in this infection, Streptococcus pneumoniae, is only intermediately susceptible to ciprofloxacin and its efficacy in this indication is poorly substantiated by the submitted data.
CHMP var af den opfattelse, at den terapeutiske indikation "sepsis forårsaget af gramnegative bakterier" ikke kunne accepteres, eftersom ansøgeren/ indehaveren af markedsføringstilladelsen ikke havde givet tilstrækkelig begrundelse for, at ciprofloxacin kunne betragtes som passende behandling af denne svære tilstand med udgangspunkt i stoffets aktivitetsniveau og tilgængelige terapeutiske alternativer.
The CHMP considered that the therapeutic indication “ septicaemia due to Gram negative bacteria” could not be accepted as the Applicant/ MAH did not provide reassurance on the fact that ciprofloxacin could be viewed as an adequate option in this severe situation with regards its level of activity and the available therapeutic alternatives.
CHMP vurderede, at den terapeutiske indikation "selektiv rensning af fordøjelsessystemet hos immunosupprimerede patienter" ikke kunne accepteres, eftersom der blandt de af ansøgeren/ indehaveren af markedsføringstilladelsen indsendte data ikke forefindes nogen specifik dokumentation til at understøtte en sådan terapeutisk anvendelse, og eftersom der ikke er enighed i de faglige kredse om anvendelsen af ciprofloxacin til denne indikation.
The CHMP was of the opinion that the therapeutic indication “ selective digestive decontamination in immuno-suppressed patients” could not be accepted, as there is an absence of specific data submitted by the Applicant/ MAH to support such therapeutic use and there is no consensus in the scientific community on the use ciprofloxacin in such indication.
CHMP var betænkelig ved den terapeutiske indikation "enkeltdosisbehandling af ukompliceret urinvejsinfektion".
The CHMP had concerns with regards to the therapeutic indication “ single dose treatment of uncomplicated UTI”.
Enkeltdosisbehandling af ukompliceret urinvejsinfektion bør ikke godkendes, medmindre den er fagligt begrundet (komparativ benefit/ risk- vurdering med 3- dages behandlingsregime er indsendt).
The single dose treatment of uncomplicated UTI should not be approved unless scientifically justified (comparative benefit/ risk assessment with the 3 day treatment regimen is provided).
Ansøgeren/ indehaveren af markedsføringstilladelsen havde ikke indsendt nogen data eller faglig redegørelse til at understøtte peroral enkeltdosisbehandling med ciprofloxacin af ukompliceret cystitis.
The Applicant/ MAH did not provide any data or scientific discussion to support the single dose oral ciprofloxacin treatment of uncomplicated cystitis.
Navnlig redegjorde ansøgeren/ indehaveren af markedsføringstilladelsen ikke for stoffets benefit/ risk- forhold i forhold til den anden og længerevarende behandling (3- dages- behandling).
In particular, the Applicant/ MAH did not discuss its benefit-risk ratio in comparison to the other longer treatment duration (3 day treatment).
12 Efter en grundig drøftelse vurderede CHMP dog, at ciprofloxacin stadig er en nyttig terapeutisk mulighed til behandling af ukompliceret cystitis.
However, after extensive discussions, the CHMP considered that ciprofloxacin still remains a useful therapeutic option in uncomplicated cystitis.
Selvom 3- dages- behandlingen har visse fordele for så vidt angår virkning, vil enkeltdosisbehandlingen på 500 mg stadig være én af behandlingsmulighederne, så længe stoffets anvendelse i tilstrækkelig grad er baseret på patienternes kliniske tilstand og de diagnostiske værktøjer.
Even if a 3-day treatment has some advantages in efficacy, the 500 mg single-dose therapy still has a place in the strategy provided its use is adequately 12 guided by the clinical status of the patients and diagnostic tools.
Efter en længerevarende drøftelse blev det aftalt at anvende forsigtige vendinger for at nedtone anbefalingen af enkeltdosisbehandlingen i forhold til 3 - dages- behandlingen og at begrænse denne mulighed til ukompliceret cystitis hos præmenopausale kvinder.
After a long discussion, an agreement was achieved to using precautionary statements for downgrading the recommendation of the single dose regimen as compared to the 3-day regimen and by restricting this possible option to uncomplicated cystitis in pre-menopausal women.
CHMP var betænkelig ved den potentielle ukontrollerede anvendelse af ciprofloxacin til empirisk behandling af shigellose eller turistdiaré og satte spørgsmålstegn ved dets virkning, især i den milde form, idet udvalget fremhævede den store risiko for udvikling af resistens.
The CHMP raised concerns on the potential uncontrolled use of ciprofloxacin in the empirical treatment of shigellosis or traveller’ s diarrhoea and questioned its effectiveness, especially in the mild form, pointing out the high risk of resistance induction.
Efter at have evalueret de af ansøgeren/ indehaveren af markedsføringstilladelsen fremlagte data vurderede CHMP, at den terapeutiske indikation til empirisk behandling med ciprofloxacin af shigellose eller turistdiaré var acceptabel med anvendelse af ordlyden "infektioner i mave- tarm- kanalen (f. eks. turistdiaré)" og begrænsede stoffets anvendelse til "svære" tilfælde i afsnit 4. 2 i følgende behandlingsregimer:
After evaluating the data presented by the Applicant/ MAH, the CHMP considered that the therapeutic indication related to the empiric ciprofloxacin treatment of Shigellosis or the traveller’ s diarrhoea was acceptable with the wording “ infections of the gastro-intestinal tract (e. g. travellers’ diarrhoea )” and restricted its use in “ severe” cases in section 4.2, with the following schedule regimens:
- Diaré forårsaget af bakterielle patogener, herunder Shigella spp., bortset fra Shigella dysenteriae,
-Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteria type 1and empirical treatment of traveller’ s diarrhoea (per os:
2 x 500 mg dagligt, 1 dag; i. v.:
2 x 500 mg/ d - 1 day, i. v:
- Diaré forårsaget af Shigella dysenteriae, type 1 (peroralt:
2 x 400 mg/ d – 1 day) -Diarrhoea caused by Shigella dysenteriae type 1 (per os:
2 x
2 x 500 mg/ d - 5 days, i. v:
400 mg dagligt, 5 dage)
2x400 mg/ d- 5 days)
Derudover anbefalede udvalget anvendelsen af følgende vending i afsnit 4. 4:
Additionally, the following statement was recommended in section 4.4:
Ved behandling af turistdiaré tilrådes det at udvise forsigtighed, især hvis rejsen er til lande, hvor der er observeret mange tilfælde af ciprofloxacin- resistent Shigella.
Caution is advised when treating traveller’ s diarrhea especially if the travel concerns countries a high rate of ciprofloxacin resistant Shigella is observed.
CHMP bad ansøgeren/ indehaveren af markedsføringstilladelsen om at redegøre for, hvorvidt ciprofloxacin kunne anses for at være en acceptabel mulighed til behandling af knogle - og ledinfektioner forårsaget af grampositive bakterier (især Staphylococcus- arterne).
The CHMP asked the applicant/ MAH to discuss the extent to which ciprofloxacin could be viewed as an acceptable option for treating bone and joints infections due to Gram-positive bacteria (in particular Staphyloccocus species).
Det fremgik af de fremlagte data, at udskrivning af ciprofloxacin ved knogle - og ledinfektioner var understøttet af adskillige kliniske undersøgelser og en omfattende anvendelse i klinisk praksis.
From the data presented, ciprofloxacin prescriptions in “ bone and joint infections” were supported by several clinical studies and an extensive use in clinical practice.
Det var derfor CHMP' s holdning, at de fremlagte data var tilstrækkelige til at omfatte den terapeutiske indikation "infektioner i knogler og led" i markedsføringstilladelserne for ciprofloxacin, og CHMP bemærkede, at produktresuméet bør give klar besked om behovet for samtidig administration af et eller flere passende antimikrobielle stoffer.
Therefore, the CHMP considered that the data provided was sufficient to include the therapeutic indication “ Infections of the bones and joints” in Ciprofloxacin Marketing Authorisations, and noted that the SPC should give a clear message on the need for co-administration with appropriate antibacterial agent(s).
13 CHMP bad ansøgeren/ indehaveren af markedsføringstilladelsen om at redegøre for, hvorvidt ciprofloxacin kunne anses for at være en acceptabel mulighed til behandling eller profylakse hos patienter med svær neutropeni.
The CHMP asked the applicant/ MAH to discuss the extent to which ciprofloxacin could be viewed as an acceptable option in the treatment or prophylaxis in patients with severe neutropenia.
Ansøgeren/ indehaveren af markedsføringstilladelsen fremlagde dokumentation til støtte for anvendelsen af ciprofloxacin som en nyttig terapeutisk behandlingsmulighed til såvel profylakse som behandling hos febrile neutropeniske patienter.
The applicant/ MAH provided documentation to support the use of ciprofloxacin as a valuable therapeutic option both prophylaxis and treatment of febrile neutropenic patients.
Når et skift til peroral behandling er muligt, anbefales en dosering på 750 mg ciprofloxacin 2 gange dagligt.
In patients with low-risk neutropenic
Hos patienter med lav- risiko neutropenisk feber kan en dosering på 750 mg ciprofloxacin 2 gange dagligt også anvendes.
13 fever, a 750 mg bid ciprofloxacin regimen can also be used.
"Ciprofloxacin bør administreres samtidigt med passende antibakterielle stoffer i overensstemmelse med de officielle retningslinjer".
Therefore, the following statement was recommended in Section 4.2 of the SPC: “ ciprofloxacin should be co-administered with appropriate antibacterial agents in accordance to official guidance”.
For så vidt angår profylakse hos neutropeniske patienter, fremgik det af de undersøgelser, som ansøgeren/ indehaveren af markedsføringstilladelsen indsendte, at resultaterne fra behandlingsgrupperne var sammenlignelige.
With regards to the prophylaxis in neutropenic patients, the studies submitted by the Applicant/ MAH showed comparable results between treatment groups.
I overensstemmelse med de indsendte data blev benefit/ risk- forholdet ved profylakse anset for at være positivt hos patienter med et neutrofiltal på mindre end 1 000/ mm3.
In line with the data submitted, the benefit/ risk in prophylaxis was regarded as favourable in patients with neutrophil count less than 1000/ mm3.
CHMP anbefalede derfor den følgende ordlyd for at skelne mellem de specifikke indikationer til profylaktisk og kurativ anvendelse af ciprofloxacin hos neutropeniske patienter:
The CHMP therefore recommended the following wording to distinguish, by specific indications, the prophylactic and curative uses of ciprofloxacin in neutropenic patients with the following wording: -treatment of infections in neutropenic patients, -prophylaxis of infections in neutropenic patients.
Behandling af infektioner forårsaget af Bacillus anthracis CHMP bad ansøgeren/ indehaveren af markedsføringstilladelsen om at fremlægge en opdateret gennemgang af de ikke- kliniske data (herunder for dyr) og af den hidtidige kliniske erfaring med anvendelse af ciprofloxacin mod lungemiltbrand.
Treatment of infections caused by Bacillus Anthracis The CHMP asked the Applicant/ MAH to provide an updated review of the non clinical data (including animal data) and on the clinical experience gained up to now in the use of ciprofloxacin in inhalation anthrax.
Ansøgeren/ indehaveren af markedsføringstilladelsen fremlagde rapporter, der sammenfattede resultaterne af en litteratursøgning fra 2001 til 2006, herunder vedrørende dyreforsøg og kliniske artikler.
The Applicant/ MAH provided reports summarizing the results of a literature search from 2001 to 2006, including animal model and clinical articles.
Under henvisning til manglen på kliniske data til understøttelse af anvendelsen af ciprofloxacin mod miltbrand foreslog ansøgeren/ indehaveren af markedsføringstilladelsen indsættelsen af en vending i afsnit 5. 1.
Referring to the lack of clinical data to support the use of ciprofloxacin in anthrax, the applicant/ MAH proposed a statement in section 5.1.
CHMP var imidlertid af den holdning, at den særlige kontekst, som miltbrand optræder i (dvs. bioterrorisme), krævede en afvigelse fra det sædvanlige krav om kliniske data og en benefit/ risk - vurdering.
However, the CHMP considered that the particular context of anthrax (i. e. bioterrorism) required deviation from the usual requirement of clinical data and the benefit assessment.
For så vidt angår lunge -, tarm - og hudmiltbrand foreslog EMEA i 2002 retningslinjer for bl. a. den anbefalede anvendelse af ciprofloxacin som førstevalgsbehandling.
With regards to inhalation, intestinal and cutaneous anthrax, EMEA proposed guidelines in 2002 including the recommended use of ciprofloxacin in a first line treatment.
14 Samlet set var CHMP af den opfattelse, at miltbrand fortsat skulle være blandt indikationerne for at undgå forvirring for de ordinerende læger og for at være konsistent med såvel EU' s egne som internationale retningslinjer for ciprofloxacin som førstevalgsbehandling.
In summary, the CHMP was of the opinion that anthrax should remain part of the indications to avoid any confusion for prescribers and to be consistent with EU and international guidelines including a recommendation on ciprofloxacin as a first line treatment.
"Lungemiltbrand (profylakse efter udsættelse for smitte og kurativ behandling)" for perorale og intravenøse farmaceutiske formuleringer.
The proposed wording of the therapeutic indications was as follows: “ Inhalation anthrax (post exposure prophylaxis and curative treatment )” for oral and IV pharmaceutical presentations.
Den følgende vending i afsnit 5. 1, der henviser til denne indikation, blev også anbefalet:
A statement in section 5.1 referring to this indication was also recommended as follows:
Der er gennemført undersøgelser af infektioner forårsaget af inhalerede Bacillus anthracis- sporer i dyreforsøg; det blev i disse undersøgelser påvist, at indgift af antibiotika tidligt efter udsættelse for smitte forebygger sygdommen, hvis behandlingen fortsættes, indtil antallet af sporer i organismen er faldet til under den infektiøse 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 anvendelse hos mennesker er primært baseret på in vitro- følsomhed og på data fra dyreforsøg samt begrænsede data fra mennesker.
The recommended use in human subjects is based primarily on in vitro susceptibility and on animal experimental data together with limited human data.
En behandling af to måneders varighed hos voksne med 500 mg ciprofloxacin peroralt to gange dagligt anses for at være effektiv til forebyggelse af miltbrandinfektioner 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 14 anthrax infection in humans.
Den behandlende læge skal rådføre sig med nationale og/ eller internationale konsensusdokumenter vedrørende behandling af miltbrand.
The treating physician is referred to national and / or international consensus documents regarding treatment of anthrax
CHMP bad ansøgeren/ indehaveren af markedsføringstilladelsen om at fremlægge en begrundet redegørelse for anvendelsen af ciprofloxacin til profylakse af invasive infektioner hos voksne med henblik på at harmonisere den terapeutiske styring af patienterne.
The CHMP asked the applicant/ MAH to provide a substantiated discussion on the use of ciprofloxacin in prophylaxis of invasive infections of adults, to harmonize the therapeutic management of patients.