natgillin/translations-raw huggingface dataset:
Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller du får bivirkninger, som ikke er nævnt her.
396 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
406 Indehaveren af markedsføringstilladelsen og fremstiller
Marketing Authorisation Holder and Manufacturer
{Navn og adresse} < {Tlf} > < {Fax} > < {Email} >
398 {Name and address} < {tel} > < {fax} > < {e-mail} >
Ciproxine Ciproxin Ciproxin Ciproxin Ciflox Ciproxin Ciproxin Ciproxin Ciflox; Ciproxin Ciproxine Ciproxin Ciproxin Ciproxin
Ciproxine Ciproxin Ciproxin Ciproxin Ciflox Ciproxin Ciproxin Ciproxin Ciproxin Ciproxine Ciproxin Ciproxin Ciproxin
Følgende oplysninger er kun til læger og sundhedspersonale:
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only
407 Hos voksne patienter er infusionstiden 60 minutter for 400 mg Ciprofloxacin Bayer og 30 minutter for 200 mg Ciprofloxacin Bayer.
In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin Bayer and 30 minutes for 200 mg Ciprofloxacin Bayer.
Med mindre kompatibiliteten med andre infusionsopløsninger/ lægemidler er bekræftet, skal infusionsopløsningen altid gives separat.
Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must
408 INDLÆGSSEDDEL:
400 PACKAGE LEAFLET:
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]
• lungeinfektioner og infektioner i bronkierne hos børn og unge, som har cystisk fibrose • komplicerede urinvejsinfektioner, herunder infektioner som har nået nyrerne (pyelonephritis),
401 • lung and bronchial infections in children and adolescents suffering from cystic fibrosis • complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) • anthrax inhalation exposure
• Du kan opleve symptomer på neuropati, som f. eks. smerte, brændende fornemmelse, prikken og stikken, følelsesløshed og/ eller slaphed.
402 • You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness.
410 • Der kan komme diaré, mens du behandles med antibiotika, herunder Ciprofloxacin Bayer, selv flere uger efter, at du er stoppet med at anvende dem.
• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin Bayer, or even several weeks after you have stopped using them.
Ciprofloxacin Bayer kan øge koncentrationen i blodet af følgende stoffer:
403 Ciprofloxacin Bayer may increase the levels of the following medicines in your blood:
411 Brug af Ciprofloxacin Bayer sammen med mad og drikke
Taking Ciprofloxacin Bayer with food and drink
SÅDAN BRUGES CIPROFLOXACIN BAYER
3 HOW TO USE CIPROFLOXACIN BAYER
412 4.
404 4.
413
405
2 Vær ekstra forsigtig med Ciprofloxacin Bayer), små nåleformede
Take special care with Ciprofloxacin Bayer), small, pin -point
- problemer i forbindelse med nervesystemet som f. eks. smerte, brændende fornemmelse, stikken
- troubles associated with the nervous system such as pain, burning, tingling, numbness and/ or
og prikken, følelsesløshed og/ eller slaphed i arme/ ben.
weakness in extremities
414 [Se bilag I – Udfyldes nationalt]
406 [See Annex I - To be completed nationally]
Holland:
Czech Republic Germany:
Polen:
Italy:
Slovakiet:
Luxembourg:
Tyskland:
Malta:
Ciproxine Ciproxin Ciproxin Ciproxin Ciproxin Ciproxine Ciproxin Ciprobay Ciprobay Ciproxin Ciprobay Ciprobay; Ciprofloxacin ANTIBAC; Ciprofloxacin BAYER; Ciprofloxacin VITAL
Ciproxin Ciprobay Ciproxin Ciproxin Ciproxine Ciproxin
Ungarn:
Netherlands:
Østrig:
Ciproxin Poland:
Ciprobay Ciproxin
Ciprobay
415 Ciprofloxacin skal anvendes til intravenøs infusion.
Ciprofloxacin Bayer should be administered by intravenous infusion.
Langsom infusion i en stor vene vil minimere patienternes ubehag og nedsætte risikoen for venøs irritation.
407 discomfort and reduce the risk of venous irritation.
Med mindre kompatibiliteten med andre infusionsopløsninger/ lægemidler er bekræftet, skal infusionsopløsningen altid gives separat.
Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must always be administered separately.
Der er inkompatibilitet med alle infusionsopløsninger/ lægemidler, som er fysisk eller kemisk ustabile ved opløsningens pH (fx penicilliner, heparinopløsninger), specielt i kombination med opløsninger, som er justeret til en basisk pH (ciprofloxacin- infusionopløsningernes pH:
Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillin, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions:
416 INDLÆGSSEDDEL:
408 PACKAGE LEAFLET:
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]
• lungeinfektioner og infektioner i bronkierne hos børn og unge, som har cystisk fibrose • komplicerede urinvejsinfektioner, herunder infektioner som har nået nyrerne (pyelonephritis),
409 • lung and bronchial infections in children and adolescents suffering from cystic fibrosis • complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) • anthrax inhalation exposure
- hvis du er overfølsom (allergisk) over for det aktive stof, over for anden bakteriedræbende
Taking other medicines)
• Du kan opleve symptomer på neuropati, som f. eks. smerte, brændende fornemmelse, prikken og stikken, følelsesløshed og/ eller slaphed.
410 • You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness.
418 • Der kan komme diaré, mens du behandles med antibiotika, herunder Ciprofloxacin Bayer, selv flere uger efter, at du er stoppet med at anvende dem.
• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin Bayer, or even several weeks after you have stopped using them.
• pentoxifyllin (forstyrrelser i blodomløbet) • koffein
411 • pentoxifylline (for circulatory disorders) • caffeine
419 Brug af Ciprofloxacin Bayer sammen med mad og drikke
Taking Ciprofloxacin Bayer with food and drink
Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller du får bivirkninger, som ikke er nævnt her.
412 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
420 Almindelige bivirkninger (forekommer hos mellem 1 og 10 af hver 100 personer):
Common side effects (between 1 and 10 in every 100 people are likely to get these):
422 < {Tlf} > < {Fax} > < {Email} >
414 {Name and address} < {tel} > < {fax} > < {e-mail} >
Grækenland:
Cyprus Czech Republic France:
Slovakiet:
Poland:
Slovenien:
Portugal:
Tjekkiet:
Slovak Republic:
Tyskland:
Slovenia:
Ciproxine Ciprobay Ciproxin Ciflox Ciproxin Ciproxin Ciproxin Ciflox; Ciproxin Ciproxine Ciproxin Ciprobay Ciproxina Ciprobay Ciprobay Ciprobay Ciproxin Ciprobay Ciprobay; Ciprofloxacin ANTIBAC; Ciprofloxacin BAYER; Ciprofloxacin VITAL
Ciproxin Ciprobay Ciproxin Ciproxin Ciproxine Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Ciprobay Ciprobay
Østrig:
Ciproxin
423 Ciprofloxacin skal anvendes til intravenøs infusion.
415 Ciprofloxacin Bayer should be administered by intravenous infusion.
424 INDLÆGSSEDDEL:
416 PACKAGE LEAFLET:
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]
• lungeinfektioner og infektioner i bronkierne hos børn og unge, som har cystisk fibrose • komplicerede urinvejsinfektioner, herunder infektioner som har nået nyrerne (pyelonephritis),
417 • lung and bronchial infections in children and adolescents suffering from cystic fibrosis • complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) • anthrax inhalation exposure
• Du kan opleve symptomer på neuropati, som f. eks. smerte, brændende fornemmelse, prikken og stikken, følelsesløshed og/ eller slaphed.
418 • You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness.
426 • Der kan komme diaré, mens du behandles med antibiotika, herunder Ciprofloxacin Bayer, selv flere uger efter, at du er stoppet med at anvende dem.
• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin Bayer, or even several weeks after you have stopped using them.
• pentoxifyllin (forstyrrelser i blodomløbet) • koffein
419 • pentoxifylline (for circulatory disorders) • caffeine
427 Brug af Ciprofloxacin Bayer sammen med mad og drikke
Taking Ciprofloxacin Bayer with food and drink
428 4.
420 4.
- leverbetændelse (hepatitis), døde leverceller (levernekrose), som meget sjældent kan føre til
421
livstruende leversvigt
- hepatitis, death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure
Udseende og pakningstørrelset
What Ciprofloxacin Bayer looks like and contents of the pack
430 [Se bilag I – Udfyldes nationalt]
422 [See Annex I - To be completed nationally]
Bulgarien:
Austria:
Frankrig:
Bulgaria:
Grækenland:
Czech Republic France:
Ciprobay Coflox Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Ciprobay Ciprobay Ciproxin Ciprobay Ciprobay; Ciprofloxacin ANTIBAC; Ciprofloxacin BAYER; Ciprofloxacin VITAL
Ciproxin Ciprobay Ciproxin Ciproxin Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Ciprobay Ciprobay
431 For at bevare virkningen af denne medicin skal du derfor:
Consequently, to preserve the efficacy of this drug:
Ciprofloxacin skal anvendes til intravenøs infusion.
423 Ciprofloxacin Bayer should be administered by intravenous infusion.
432
424
London, den 7. oktober 2008 Dok. ref.
Ref.
EMEA/ CHMP/ 554234/ 2008
EMEA/ CHMP/ 384874/ 2008
UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 30 OM Ciprofloxacin Bayer og tilknyttede navne Internationalt fællesnavn (INN): ciprofloxacin
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Ciprofloxacin Bayer and associated names International Non-Proprietary Name (INN): ciprofloxacin
Ciprofloxacin Bayer og tilknyttede navne er et antibiotikum, indiceret til behandling af ukomplicerede og komplicerede infektioner, bl. a. svære infektioner, som skyldes ciprofloxacinfølsomme patogener.
Ciprofloxacin Bayer and associated names is an antibiotic, indicated for the treatment of uncomplicated and complicated infections, including severe infections, caused by ciprofloxacin susceptible pathogens.
Den 22. juni 2007 indbragte Frankrig en sag for EMEA i henhold til artikel 30 i direktiv 2001/ 83/ EF, med senere ændringer, med henblik på harmonisering af de nationalt godkendte produktresuméer, etikettering og indlægsseddel for lægemidlet Ciprofloxacin Bayer og tilknyttede navne.
On 22 June 2007, France presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Ciprofloxacin Bayer and associated names.
Grundlaget for indbringelsen af sagen var, at der var afvigelser mellem de produktresuméer, der var godkendt for Ciprofloxacin Bayer og tilknyttede navne i EU- medlemsstaterne, med hensyn til indikationer, dosering, kontraindikationer og særlige advarsler og forsigtighedsregler vedrørende brugen.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Ciprofloxacin Bayer and associated names approved across EU Member States, with respect to the indications, the posology, the contra-indications and the special warnings and precautions for use.
De faglige konklusioner findes i bilag II og det ændrede produktresumé og den ændrede etikettering og indlægsseddel i bilag III.
The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Europa- Kommissionen traf en afgørelse den 7. oktober 2008.
A Decision was issued by the European Commission on 7 October 2008.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM( ER), STYRKE( R), INDGIVELSESVEJ( E), ANSØGER( E), INDEHAVER( E) AF MARKEDSFØRINGSTILLADELSE( R) I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Postbus 2379 NL- 5202 CJ´s Hertogenbosch Holland Tel- No.:
Postbus 2379 NL-5202 CJ´s Hertogenbosch Netherlands Tel-No.:
Ciprofloxacin Kabi 100 mg/ 50 2 mg/ ml ml, solution for infusion
Ciprofloxacin Kabi 100 2 mg/ ml mg/ 50 ml, solution for infusion
Infusionsvæske, opløsning
Solution for infusion Intravenous use
Postbus 2379 NL- 5202 CJ´s Hertogenbosch, Holland Tel- No.:
Postbus 2379 NL-5202 CJ´s Hertogenbosch, Netherlands Tel-No.:
Ciprofloxacin Kabi 200 mg/ 100 2 mg/ ml ml, solution for infusion
Ciprofloxacin Kabi 200 2 mg/ ml mg/ 100 ml, solution for infusion
Ciprofloxacin Kabi 400 mg/ 200 2 mg/ ml ml, solution for infusion
Ciprofloxacin Kabi 400 2 mg/ ml mg/ 200 ml, solution for infusion
Østrig
2 Austria
Fresenius Kabi Austria GmbH, Hafnerstraße 36, A- 8055 Graz, Østrig Tel- No.:
Fresenius Kabi Austria GmbH, Hafnerstraße 36, A-8055 Graz, Austria Tel-No.:
2 Østrig
Austria
Molenberglei 7 B- 2627 Schelle, Belgien Tel- No.:
Molenberglei 7 B-2627 Schelle, Belgium Tel-No.:
Fresenius Kabi N. V. Molenberglei 7B- 2627 Schelle, Belgien Tel- No.:
Fresenius Kabi N. V. Molenberglei 7B-2627 Schelle, Belgium Tel-No.:
Cypern
3 Cyprus
Ciprofloxacin Kabi 100 mg/ 50 2 mg/ ml ml,
Ciprofloxacin Kabi 100 mg/ 50 ml,
Infusionsvæske, opløsning
2 mg/ ml
Til intravenøs anvendelse
Solution for infusion Intravenous use
GR 153- 41 Agia Paraskevi solution for infusion Attica, Grækenland Tel- No.:
GR 153-41 Agia Paraskevi solution for infusion Attica, Greece Tel-No.:
Ciprofloxacin Kabi 200 mg/ 100 2 mg/ ml ml,
Ciprofloxacin Kabi 200 mg/ 100 ml,
Ciprofloxacin Kabi 400 mg/ 200 2 mg/ ml ml,
Ciprofloxacin Kabi 400 mg/ 200 ml,
Postbus 2379 NL- 5202 CJ´s Hertogenbosch, Holland Tel- No.:
Fresenius Kabi Nederland Ciprofloxacin Kabi 100 B. V. mg/ 50 ml, Postbus 2379 solution for infusion NL-5202 CJ´s Hertogenbosch, Netherlands Tel-No.:
Ciprofloxacin Kabi 100 mg/ 50 2 mg/ ml ml, solution for infusion
2 mg/ ml
Den Tjekkiske republik
4 Czech Republic
Postbus 2379 NL- 5202 CJ´s Hertogenbosch, Holland Tel- No.:
Fresenius Kabi Nederland Ciprofloxacin Kabi 200 2 mg/ ml B. V. mg/ 100 ml, Postbus 2379 solution for infusion NL-5202 CJ´s Hertogenbosch, Netherlands Tel-No.:
Ciprofloxacin Kabi 200 mg/ 100 2 mg/ ml ml, solution for infusion
Solution for infusion Intravenous use
4 Den Tjekkiske republik
Czech Republic
Postbus 2379 NL- 5202 CJ´s Hertogenbosch, Holland Tel- No.:
Fresenius Kabi Nederland Ciprofloxacin Kabi 400 2 mg/ ml B. V. mg/ 200 ml, Postbus 2379 solution for infusion NL-5202 CJ´s Hertogenbosch, Netherlands Tel-No.:
Ciprofloxacin Kabi 400 mg/ 200 2 mg/ ml ml, solution for infusion
Solution for infusion Intravenous use
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Tyskland Tel- No.:
Fresenius Kabi Deutschland Ciprofloxacin Kabi 100 2 mg/ ml GmbH, D-61346 Bad mg/ 50 ml, solution for Homburg infusion v. d. H. ,GermanyTel-No.:
Ciprofloxacin Kabi 100 mg/ 50 2 mg/ ml ml, solution for infusion
Solution for infusion Intravenous use
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Tyskland Tel- No.:
Fresenius Kabi Deutschland Ciprofloxacin Kabi 200 2 mg/ ml GmbH, mg/ 100 ml, D-61346 Bad Homburg solution for infusion v. d. H., Germany Tel-No.:
Tyskland
5 Germany
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Tyskland Tel- No.:
Fresenius Kabi Deutschland GmbH, D-61346 Bad Homburg v. d. H., Germany Tel-No.:
5 Danmark
Denmark
Fresenius Kabi AB SE- 75174 Uppsala Sverige Tel- No.:
Fresenius Kabi AB SE-75174 Uppsala Sweden Tel-No.:
Ciprofloxacin Fresenius Kabi 2 2 mg/ ml mg/ ml, solution for infusion
Ciprofloxacin Fresenius 2 mg/ ml Kabi 2 mg/ ml, solution for infusion
Ciprofloxacin Kabi 100 mg/ 50 2 mg/ ml ml,
Ciprofloxacin Kabi 100 2 mg/ ml mg/ 50 ml, solution for infusion
0030 210 654 8909 Grækenland
Greece
0030 210 654 8909 Grækenland
0030 210 654 8909
Ciprofloxacin Kabi 400 mg/ 200 2 mg/ ml ml,
Solution for infusion Intravenous use
Infusionsvæske, opløsning
200 mg/ 100 ml
Til intravenøs anvendelse
6 Greece
400 mg/ 200 ml
Fresenius Kabi Hellas A. E.
GR 153- 41 Agia Paraskevi solution for infusion Attica, Grækenland Tel- No.:
Ciprofloxacin Kabi 400 2 mg/ ml 354 Messoghoin Avenue mg/ 200 ml, GR 153-41 Agia Paraskevi solution for infusion Attica, Greece Tel-No.:
0030 210 654 8909 Spanien
0030 210 654 8909
Fresenius Kabi España S. A. c. / Marina 16- 18, planta 17, E- 08005 Barcelona, Spanien Tel- No.:
Fresenius Kabi España Ciprofloxacin Kabi 2 2 mg/ ml S. A. c. / Marina 16-18, planta mg/ ml, solution for 17, E-08005 infusion Barcelona, SpainTel-No.:
6 Finland
Finland
Fresenius Kabi AB SE- 75174 Uppsala Sverige Tel- No.:
Fresenius Kabi AB Ciprofloxacin Fresenius 2 mg/ ml SE-75174 Uppsala Kabi 2 mg/ ml, solution Sweden for infusion Tel-No.:
Ciprofloxacin Fresenius Kabi 2 2 mg/ ml mg/ ml, solution for infusion
Solution for infusion Intravenous use
Ungarn
7 Hungary
Fresenius Kabi Italia S. r. L. via Camagre 41 I- 37063 Isola della Scala (VR), Italien Tel- No.:
Fresenius Kabi Italia S. r. L. via Camagre 41 I-37063 Isola della Scala (VR), Italy Tel-No.:
7 Italien
Italy
Polen
8 Poland
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Tyskland Tel- No.:
Fresenius Kabi Deutschland GmbH, D-61346 Bad Homburg v. d. H. ,GermanyTel-No.:
8 Portugal
Portugal
Fresenius Kabi Pharma
Fresenius Kabi Pharma Portugal Lda., Avenida do
Ciprofloxacin Kabi 100 mg/ 50 2 mg/ ml Infusionsvæske,
Ciprofloxacin Kabi 100 2 mg/ ml mg/ 50 ml,
Til intravenøs
Solution for infusion Intravenous use
Portugal Lda., Avenida do ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794- 039 Carnaxide, Portugal Tel- No.:
Forte 3, Edifício Suécia IV, Piso 3, 2794-039 Carnaxide, Portugal Tel-No.:
Portugal
9 Portugal
Ciprofloxacin Kabi 200 mg/ 100 2 mg/ ml Infusionsvæske,
Ciprofloxacin Kabi 200 2 mg/ ml
Portugal Lda., Avenida do ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794- 039 Carnaxide, Portugal Tel- No.:
Portugal Lda., Avenida do mg/ 100 ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794-039 Carnaxide, Portugal Tel-No.:
opløsning
Fresenius Kabi Pharma
anvendelse
Ciprofloxacin Kabi 400 2 mg/ ml
Portugal
400 mg/ 200 ml
Fresenius Kabi Pharma Ciprofloxacin Kabi 400 mg/ 200 2 mg/ ml Portugal Lda., Avenida do ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794- 039 Carnaxide, Portugal Tel- No.:
Portugal Lda., Avenida do mg/ 200 ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794-039 Carnaxide, Portugal Tel-No.:
Til intravenøs anvendelse
200 mg/ 100 ml, 400 mg/ 200 ml
200 mg/ 100 ml, 400 mg/ 200 ml
Solution for infusion Intravenous use
9 Slovakiet
100 mg/ 50 ml
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Tyskland Tel- No.:
Homburg v. d. H. ,Germany infusion Tel-No.:
Til intravenøs anvendelse
10 Slovak Republic
Storbritannie n
United Kingdom
Fresenius Kabi Limited Cestrian Court, Eastgate Way Manor Park, Runcorn Cheshire WA7 1NT, Storbritannien Tel- No.:
Fresenius Kabi Limited Cestrian Court, Eastgate Way Manor Park, Runcorn Cheshire WA7 1NT, UK, Tel-No.:
Ciprofloxacine Kabi 100 mg/ 50 2 mg/ ml ml, solution for infusion
Ciprofloxacine Kabi 100 2 mg/ ml mg/ 50 ml, solution for infusion
10 Storbritannie n
United Kingdom
Fresenius Kabi Limited Cestrian Court, Eastgate Way Manor Park, Runcorn Cheshire WA7 1NT, Storbritannien Tel- No.:
Fresenius Kabi Limited Cestrian Court, Eastgate
2 mg/ ml
11 United Kingdom
Infusionsvæske, opløsning
Fresenius Kabi Limited Cestrian Court, Eastgate
Til intravenøs anvendelse
Ciprofloxacine Kabi 400 2 mg/ ml mg/ 200 ml,
200 mg/ 100 ml
Solution for infusion Intravenous use
Storbritannie n
400 mg/ 200 ml
Fresenius Kabi Limited Cestrian Court, Eastgate Way Manor Park, Runcorn Cheshire WA7 1NT, Storbritannien Tel- No.:
Way Manor Park, Runcorn solution for infusion Cheshire WA7 1NT, UK, Tel-No.:
11 BILAG II
12 ANNEX II
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉERNE, ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
12 FAGLIGE KONKLUSIONER
13 SCIENTIFIC CONCLUSIONS
Ciprofloxacin har en hurtigt indsættende baktericid virkning, der beror på hæmning af dna- gyrase og deraf følgende hæmning af dna- syntesen.
Ciprofloxacin exerts a rapid bactericidal effect by inhibiting DNA-gyrase, resulting in inhibition of DNA synthesis.
Efter oral indgift absorberes Ciprofloxacin hurtigt og effektivt.
Ciprofloxacin is rapidly and effectively absorbed after oral administration.
Behandlingen af komplicerede urinvejsinfektioner består i dag i empirisk behandling med et bredspektret antibiotikum (fluorquinolon) og mulig efterfølgende behandling i 10- 14 dage på grundlag af urindyrkning og følsomhed.
Management of patients with complicated urinary tract infections (UTIs) currently includes empirical treatment with a broad-spectrum antibiotic (fluoroquinolone), and potential subsequent treatment for 10-14 days based on urine culture and sensitivity.
Hvis behandlingssvigt og resistensdannelse skal undgås, forudsætter dette, at såvel patientens compliance som doseringen er tilstrækkelig.
In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient’ s compliance and dosing need to be adequate.
Under indbringelsesproceduren blev ansøgeren/ indehaveren af markedsføringstilladelsen anmodet om at fremlægge:
During the referral procedure the Applicant/ Marketing Authorisation Holder was requested to submit:
Kliniske data og en gennemgang af benefit/ risk- forholdet for den ansøgte dosering til urinvejsinfektioner.
1. clinical data and discuss the risk/ benefit of the proposed dose in urinary tract infections (UTI).
Ansøgeren/ indehaveren af markedsføringstilladelsen skulle redegøre for sikkerheden og virkningen af doseringen 100 mg to gange dagligt og 200- 400 mg to gange dagligt.
The applicant/ MAH should discuss both the 100 mg twice daily (bid) dose and the 200 – 400 mg bid dose from a safety and efficacy point of view.
I denne forbindelse skulle ansøgeren/ indehaveren af markedsføringstilladelsen redegøre for data vedrørende komplicerede og ukomplicerede øvre og nedre urinvejsinfektioner.
In doing so the applicant/ MAH should discuss the data in relation to complicated and uncomplicated, upper and lower urinary tract infections.
Kliniske data og redegørelse for benefit/ risk- forholdet for den maksimale daglige dosis, dvs. hvorvidt denne burde være 400 mg to gange dagligt eller 400 mg tre gange dagligt.
2. clinical data and discuss the risk/ benefit of the maximum adult daily dose, i. e. whether it should be 400 mg bid or 400 mg three times daily.
Ansøgeren/ indehaveren af markedsføringstilladelsen forelagde ikke kliniske data som led i besvarelsen af spørgsmålene om benefit/ risk- forholdet for den ansøgte dosering ved urinvejsinfektioner og den maksimale daglige dosis til voksne, idet der er tale om en generisk ansøgning (referencelægemidlet/ det oprindelige lægemiddel er Ciproxin (Bayer)).
The applicant/ MAH did not submit any clinical data to address the questions related to the risk/ benefit of the proposed dose in UTIs and the maximum adult daily dose, as this application is a so called ″ generic″ application (reference product/ originator Ciproxin from Bayer).