natgillin/translations-raw huggingface dataset:
Brug ikke Ciprofloxacin Hikma efter den udløbsdato, der står på pakningen efter “ Exp ”.
Do not use Ciprofloxacin Hikma after the expiry date which is stated on the packaging after “ Exp”.
• Må ikke opbevares i køleskab eller nedfryses. • Opbevares i den originale yderpakning indtil brug for at beskytte mod lys.
• Do not refrigerate or freeze. • Keep the vial in the outer carton until time of use in order to protect from light.
Ciprofloxacin Hikma indeholder Aktivt stof: ciprofloxacin- laktat.
What Ciprofloxacin Hikma contains
Hvert hætteglas med 100 ml indeholder 200 mg ciprofloxacin.
Each vial of 100 ml contains 200 mg of ciprofloxacin.
Øvrige indholdsstoffer: mælkesyre (E270), natriumchlorid, saltsyre (E507) til justering af pH- værdi og vand til injektioner.
The other ingredients are lactic acid (E270), sodium chloride, hydrochloric acid (E507) for pH adjustment and water for injections.
30 Ciprofloxacin Hikma er en steril, klar og farveløs til let gullig opløsning til infusion.
What Ciprofloxacin Hikma looks like and contents of the pack Ciprofloxacin Hikma is a sterile, clear and colourless to slightly yellow solution for infusion.
Estrada do Rio da Mó n. º 8, 8A e 8B – Fervença 2705- 906 Terrugem SNT Portugal Tlf.: +351 219 608 410 Fax: +351 219 615 102 geral@ hikma. pt
Estrada do Rio da Mó n. º 8, 8A e 8B – Fervença 2705-906 Terrugem SNT Portugal Tel.: +351 219 608 410 Fax: +351 219 615 102 geral@hikma. pt
Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:
This medicinal product is authorised in the Member States of EEA under the following names:
Østrig – Ciprofloxacin Hikma 200 mg/ 100 ml Infusionslösung Tyskland – Ciprofloxacin Hikma 200 mg/ 100 ml Lösung zur Intravenösen Anwendung Irland – Ciprofloxacin Hikma 200 mg/ 100 ml Solution for Infusion Italien – Ciprofloxacin Hikma 200 mg/ 100 ml Soluzione per Infusione Endovenosa Storbritannien – Ciprofloxacin Hikma 200 mg/ 100 ml Solution for Infusion Nederlandene – Ciprofloxacine Hikma 200 mg/ 100 ml Oplossing voor Intraveneuze Infusie
Austria – Ciprofloxacin Hikma 200mg/ 100ml Infusionslösung Germany – Ciprofloxacin Hikma 200mg/ 100ml Lösung zur Intravenösen Anwendung Ireland – Ciprofloxacin Hikma 200mg/ 100ml Solution for Infusion Italy – Ciprofloxacin Hikma 200mg/ 100ml Soluzione per Infusione Endovenosa United Kingdom – Ciprofloxacin Hikma 200mg/ 100ml Solution for Infusion The Netherlands – Ciprofloxacine Hikma 200mg/ 100ml Oplossing voor Intraveneuze Infusie
Denne indlægsseddel blev senest godkendt den {MM/ YYYY}.
This leaflet was last approved in {MM/ YYYY}.
Ciprofloxacin Hikma er kompatibelt med isotonisk natriumchloridopløsning, Ringers opløsning, Ringers laktat- opløsning, 50 mg/ ml (5%) eller 100 mg/ ml (10%) glukoseopløsning og 50 mg/ ml (5%) glukoseopløsning med 2, 25 mg/ ml (0, 225%) eller 4, 5 mg/ ml (0, 45%) natriumchloridopløsning og 10% fruktoseopløsning.
Ciprofloxacin Hikma is compatible with isotonic sodium chloride solution, Ringer’ s solution, Ringer’ s lactate solution, 50 mg/ ml (5%) or 100 mg/ ml (10%) glucose solution and 50 mg/ ml (5%) glucose solution with 2.25 mg/ ml (0.225%) or 4.5 mg/ ml (0.45%) sodium chloride solution and 10% fructose solution.
Kompatibilitet med disse opløsninger er blevet bevist i ciprofloxacin - koncentrationer på 1 mg/ ml.
Compatibility with these solutions has been proven in ciprofloxacin concentrations of 1 mg/ ml.
Kemisk og fysisk stabilitet under anvendelsen er blevet påvist umiddelbart efter fortynding, efter 24 timer ved 2- 8 °C og efter 24 timer ved stuetemperatur.
Chemical and physical in-use stability has been demonstrated immediately after dilution, after 24 hours at 2-8°C and after 24 hours at room temperature.
Medmindre kompatibilitet er bevist, skal infusionsvæsken altid indgives separat.
Unless compatibility is proven, the solution for infusion should always be administered separately.
London, den 11. juli 2007 EMEA/ CHMP/ 75066/ 2007
London, 11 July 2007 EMEA/ CHMP/ 75066/ 2007
UDTALELSE EFTER EN INDBRINGELSE I HENHOLD TIL ARTIKEL 29, STK.
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Ciprofloxacin Hikma and associated names
41, VEDRØRENDE Ciprofloxacin Hikma og tilknyttede navne Internationalt fællesnavn (INN):
International Non-Proprietary Name (INN):
Ciprofloxacin, infusionsvæske, opløsning, 2 mg/ ml, og tilknyttede navne er et antibiotikum, der tilhører quinolongruppen og er effektivt in vitro mod en lang række gramnegative aerobe bakterier foruden visse grampositive organismer.
Ciprofloxacin Hikma and associated names, 2 mg/ ml solution for infusion, is an antibiotic belonging to the quinolone family, effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Hikma Farmaceutica Lda. har indgivet ansøgninger om gensidig anerkendelse af Ciprofloxacin Hikma og tilknyttede navne, infusionsvæske, opløsning, 2 mg/ ml, baseret på den markedsføringstilladelse, der blev udstedt af Nederlandene den 12. april 2005.
Hikma Farmaceutica Lda. submitted applications for mutual recognition of Ciprofloxacin Hikma and associated names, 2 mg/ ml solution for infusion on the basis of the marketing authorisation granted by the Netherlands on 12 April 2005.
5. 1 burde medtage de organismer, der er anført i forbindelse med tærskelværdierne og i følsomhedstabellen for indikationerne, i overensstemmelse med "Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections" (CPMP/ EWP/ 558/ 95 rev. 1).
In addition, it was considered that the applicant should include in the Summary of Product Characteristics (point 5.1) the organisms listed in the breakpoints and susceptibility table relevant to the indications, as per the Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/ EWP/ 558/ 95 rev.1).
Dr.
The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Bengt Ljungberg var medrapportør.
The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Bengt Ljungberg.
På sit møde i januar 2007 fandt CHMP på baggrund af alle de forelagte oplysninger og den faglige drøftelse i udvalget, at benefit- risk forholdet er gunstigt for Ciprofloxacin Hikma og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Ciprofloxacin Hikma and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Listen over de berørte produktnavne findes i bilag I.
The list of the product names concerned is given in Annex I.
De faglige konklusioner fremgår af bilag II, produktresuméet af bilag III.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Den endelige udtalelse blev den 11. juli 2007 omarbejdet til en beslutning af Europa- Kommissionen.
The final opinion was converted into a Decision by the European Commission on 11 July 2007.
FORTEGNELSE OVER LÆGEMIDLERNESNAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJER, INDEHAVER AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE OG NORGE OG ISLAND
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
1 Medlemsland
1 Member State
Indehaver af markedsføringstilladelsen
Marketing Authorisation Invented name Holder
Indhold (koncentratio n)
Content (concentratio n)
BAYER SA- NV Avenue Louise 143 Louizalaan 143
Bayer Austria GmbH Ciproxin Herbststraße 6-10 Ciproxin 1160 Wien Ciproxin Austria Ciproxin Ciproxin Ciproxin Ciprofloxacine « BAYER »
Ciproxine Ciproxine Ciproxine
250 mg 500 mg 750 mg 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml 200 mg/ 100 ml
infusionsvæske, opløsning infusionsvæske, opløsning filmovertrukne tabletter
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion solution for infusion solution for infusion
intravenøs anvendelse intravenøs anvendelse oral anvendelse
oral use oral use oral use intravenous use intravenous use intravenous use intravenous use
2 mg/ ml 2 mg/ ml 100 mg
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
B - 1050 Bruxelles- Brussel
Ciprofloxacine « BAYER
Ciproxine
400 mg/ 200 ml
filmovertrukne tabletter
solution for infusion
oral anvendelse
intravenous use
250 mg
2 mg/ ml
Bayer HealthCare AG D- 513 68 Leverkusen
Ciproxin Ciproxin
250 mg
5% 10%
filmovertrukne tabletter
oral suspension oral suspension
oral anvendelse
oral use oral use
Ciprobay
BAYER SA-NV Ciproxine Avenue Louise 143 Ciproxine Louizalaan 143 Ciproxine B - 1050 Bruxelles-Brussel Ciproxine Belgium
200 mg / 100ml
200 mg/ 100 ml 100 mg/ 50 ml 100 mg 250 mg
infusionsvæske, opløsning
solution for infusion solution for infusion film-coated tablets film-coated tablets
intravenøs anvendelse
intravenous use intravenous use oral use oral use
intravenøs anvendelse
2 mg/ ml 2 mg/ ml 100 mg 250 mg
tabletter med modificeret udløsning
Ciproxine Ciproxine Ciproxine Ciproxine Ciproxine
Ciproxin Ciproxin Ciproxin
500 mg 750 mg 5 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
filmovertrukne tabletter filmovertrukne tabletter infusionsvæske, opløsning
film-coated tablets film-coated tablets oral suspension solution for infusion solution for infusion
oral anvendelse oral anvendelse intravenøs anvendelse
oral use oral use oral use intravenous use intravenous use
250 mg 500 mg 2 mg/ ml
500 mg 750 mg 50 mg/ ml 2 mg/ ml 2 mg/ ml
Ciproxin
Germany Ciprobay
Ciproxin
Ciprobay
750 mg
200 mg / 100 ml
750 mg
2 mg/ ml
2 Medlemsland
2 Member State
Bayer HealthCare AG D- 513 68 Leverkusen Tyskland
Ciprobay
Ciproxin Ciproxin Ciproxin Ciproxin
400 mg/ 200 ml
filmovertrukne tabletter filmovertrukne tabletter infusionsvæske, opløsning infusionsvæske, opløsning
solution for infusion
oral anvendelse oral anvendelse intravenøs anvendelse intravenøs anvendelse
intravenous use
Finland
2 mg/ ml
250 mg 500 mg 750 mg 200 mg/ 100 ml 400 mg/ 200 ml
Ciprobay XR
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter infusionsvæske, opløsning infusionsvæske, opløsning
500 mg
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml
modified release tablets
Frankrig
oral use
Ciflox Ciflox Uniflox
500 mg
250 mg 500 mg 500 mg
Cyprus
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter
BAYER HELLAS ABEE, Greece 18-20 Sorou Street, 15125 Marousi, Athens, Greece
oral anvendelse oral anvendelse oral anvendelse
Ciproxin Ciproxin Ciproxin
250 mg 500 mg 500 mg
250 mg 500 mg 200 mg/ 100 ml
filmovertrukne tabletter suspension suspension infusionsvæske, opløsning infusionsvæske, opløsning
film-coated tablets film-coated tablets solution for infusion
oral anvendelse oral anvendelse oral anvendelse intravenøs anvendelse intravenøs anvendelse
oral use oral use intravenous use
750 mg 50 mg/ ml 100 mg / ml 2 mg/ ml 2 mg/ ml
250 mg 500 mg 2 mg/ ml
BAYER HELLAS ΑΒΕΕ 18- 20 Sorou Street
Bayer HealthCare AG D-51368 Leverkusen
CIPROXIN
Ciprobay
infusionsvæske, opløsning
solution for infusion
Maoussi 15125 Grækenland
Germany
CIPROXIN CIPROXIN CIPROXIN
Ciprobay
400 mg/ 200ml 500 mg 750 mg
400 mg/ 200 ml
infusionsvæske, opløsning filmovertrukne tabletter filmovertrukne tabletter
solution for infusion
intravenøs anvendelse oral anvendelse oral anvendelse
intravenous use
2 mg / ml 500 mg 750 mg
2 mg/ ml
Indehaver af markedsføringstilladelsen
Ciprobay Uro Ciprobay Ciprobay Ciprobay
250 mg/ 5ml 500 mg/ 5ml 500 mg
100 mg 250 mg 500 mg 750 mg
suspension suspension tabletter med modificeret udløsning
film-coated tablets film-coated tablets film-coated tablets film-coated tablets
oral anvendelse oral anvendelse oral anvendelse
oral use oral use oral use oral use
50 mg / ml 100 mg / ml 500 mg
100 mg 250 mg 500 mg 750 mg
1000 mg
Denmark
tabletter med modificeret udløsning
Bayer HealthCare AG D-51368 Leverkusen
Holland
Ciproxin
100 mg 250 mg 500 mg
250 mg
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter
film-coated tablets
oral anvendelse oral anvendelse oral anvendelse
oral use
Ciproxin Ciproxin
Ciproxin
100mg 250mg
500 mg
filmovertrukne tabletter filmovertrukne tabletter
film-coated tablets
oral anvendelse oral anvendelse
oral use
100 mg 250 mg
500 mg
Dublin 18.
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
750 mg 200 mg/ 100 ml 400 mg/ 200 ml 50 mg/ ml 100 mg/ ml
filmovertrukne tabletter filmovertrukne tabletter suspension suspension infusionsvæske, opløsning infusionsvæske, opløsning infusionsvæske, opløsning
film-coated tablets solution for infusion solution for infusion oral suspension oral suspension
oral anvendelse oral anvendelse oral anvendelse oral anvendelse intravenøs anvendelse intravenøs anvendelse intravenøs anvendelse
oral use intravenous use intravenous use oral use oral use
500 mg 750 mg 50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
750 mg 2 mg/ ml 2 mg/ ml 50 mg/ ml 100 mg/ ml
Island
Estonia
Bayer Healthcare AG 51368 Leverkusen, Tyskland
Bayer HealthCare AG D-51368 Leverkusen
250 mg 500 mg 750 mg
250 mg 500 mg
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter
film-coated tablets film-coated tablets
oral anvendelse oral anvendelse oral anvendelse
oral use oral use
250 mg 500 mg 750mg
250 mg 500 mg
4 Medlemsland
3 Member State
Ciproxin Ciproxin
Germany Ciproxin Ciproxin
infusionsvæske, opløsning infusionsvæske, opløsning
solution for infusion solution for infusion
intravenøs anvendelse intravenøs anvendelse
intravenous use intravenous use
Italien
Finland
Bayer HealthCare AG D- 51368 Leverkusen, Tyskland
Bayer HealthCare AG Ciproxin 51368 Leverkusen, Ciproxin Germany Ciproxin Ciproxin Ciproxin
filmovertrukne tabletter filmovertrukne tabletter
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion
oral anvendelse oral anvendelse
oral use oral use oral use intravenous use intravenous use
250 mg 500 mg
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml
Bayer S. p. A.
France
CIPROXIN CIPROXIN CIPROXIN
Bayer Santé Ciflox 13, rue Jean Jaurès Ciflox 92807 Puteaux Cedex Uniflox France
250 mg 500 mg 750 mg
250 mg 500 mg 500 mg
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter
film-coated tablets film-coated tablets film-coated tablets
oral anvendelse oral anvendelse oral anvendelse
oral use oral use oral use
CIPROXIN
Ciflox Ciflox Ciflox Ciflox Ciflox
500 mg
750 mg 250 mg/ 5 ml 500 mg/ 5 ml 200 mg/ 100 ml 400 mg/ 200 ml
tabletter med modificeret udløsning
film-coated tablets oral suspension oral suspension solution for infusion solution for infusion
oral anvendelse
oral use oral use oral use intravenous use intravenous use
tabletter med modificeret udløsning
750 mg 50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml
1000 mg
Germany
Letland Litauen
Bayer Vital GmbH CIPROBAY D-51368 Leverkusen CIPROBAY Germany CIPROBAY CIPROBAY URO CIPROBAY CIPROBAY CIPROBAY CIPROBAY CIPROBAY Bayer Healthcare AG Ciprofloxacin D-51368 Leverkusen, ANTIBAC
250 mg 500 mg 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
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 250 mg
suspension suspension infusionsvæske, opløsning infusionsvæske, opløsning infusionsvæske, opløsning
solution for infusion solution for infusion solution for infusion film-coated tablets film-coated tablets film-coated tablets film-coated tablets oral suspension oral suspension film-coated tablets
oral anvendelse oral anvendelse intravenøs anvendelse intravenøs anvendelse intravenøs anvendelse
intravenous use intravenous use intravenous use oral use oral use oral use oral use oral use oral use oral use
50 mg / ml 100 mg / ml 2 mg / ml 2 mg / ml 2 mg / ml
2 mg/ ml 2 mg/ ml 2 mg/ ml 100 mg 250 mg 500 mg 750 mg 50 mg/ ml 100 mg/ ml 250 mg
Luxembourg
500 mg
BAYER SA- NV Avenue Louise 143 Louizalaan 143
film-coated tablets
Ciproxine Ciproxine Ciproxine
oral use
100 mg/ 50 ml 100 mg 250 mg
4 Member State
infusionsvæske, opløsning filmovertrukne tabletter filmovertrukne tabletter
Marketing Authorisation Invented name Holder
intravenøs anvendelse oral anvendelse oral anvendelse
Strength
2 mg / ml 100 mg 250 mg
Pharmaceutical Form
B - 1050 Bruxelles- Brussel
Route of administration
Belgien
Content (concentratio n)
Ciproxine
Ciprofloxacin ANTIBAC
500 mg
750 mg
Ciproxine Ciproxine Ciproxine Ciproxine
Ciprofloxacin ANTIBAC
750 mg 5 g / 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
100 mg/ 50 ml
filmovertrukne tabletter suspension infusionsvæske, opløsning infusionsvæske, opløsning
solution for infusion
750 mg 250 mg / 5 ml 2mg / ml 2mg / ml
Ciprofloxacin ANTIBAC
5 Medlemsland
200 mg/ 100 ml
Indehaver af markedsføringstilladelsen
solution for infusion
Særnavn
intravenous use
Styrke
2 mg/ ml
Lægemiddelform
Ciprofloxacin ANTIBAC
Administrationsvej
400 mg/ 200 ml
Indhold (koncentratio n)
solution for infusion
Malta
intravenous use
Bayer PLC Consumer Care Division, Bayer House, Strawberry Hill, Newbury,
2 mg/ ml
Ciproxin Ciproxin Ciproxin
Ciprofloxacin BAYER
250mg 500mg 100 mg/ 50 ml
100 mg/ 50 ml
filmovertrukne tabletter filmovertrukne tabletter infusionsvæske, opløsning
solution for infusion
oral anvendelse oral anvendelse intravenøs anvendelse
intravenous use
RG14 1JA, Berkshire
Ciprofloxacin BAYER
Ciproxin
200 mg/ 100 ml
Storbritannien
Ciprofloxacin BAYER
Ciproxin
400 mg/ 200 ml
Bayer HealthCare AG D- 513 68 Leverkusen Tyskland
Ciprofloxacin VITAL
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
100 mg/ 50 ml
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter infusionsvæske, opløsning infusionsvæske, opløsning
solution for infusion
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml
intravenous use
Polen
2 mg/ ml
100 mg 250 mg 500 mg 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
200 mg/ 100 ml
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter infusionsvæske, opløsning infusionsvæske, opløsning infusionsvæske, opløsning
solution for infusion
100 mg 250 mg 500 mg 2 mg/ ml 2 mg/ ml 2 mg/ ml
intravenous use
Portugal
2 mg/ ml
Bayer Portugal, S. A.
Ciprofloxacin VITAL
250 mg 500 mg 750 mg
400 mg/ 200 ml
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter
solution for infusion
oral anvendelse oral anvendelse oral anvendelse
intravenous use
250 mg 500 mg 750 mg
2 mg/ ml
Ciproxina OD
BAYER HELLAS ΑΒΕΕ CIPROXIN 18-20 Sorou Street
500 mg
100 mg/ 50 ml
tabletter med modificeret udløsning
solution for infusion
Ciproxina OD
15125 Marousi, Athens, CIPROXIN Greece
1000 mg
200 mg/ 100 ml
1000 mg
2 mg/ ml
Ciproxina Ciproxina Ciproxina
CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN
10g/ 100 ml 5 g/ 100 ml 200 mg/ 100 ml
400 mg/ 200 ml 500 mg 750 mg 250 mg/ 5 ml 500 mg/ 5 ml
suspension suspension infusionsvæske, opløsning
solution for infusion film-coated tablets film-coated tablets oral suspension oral suspension
oral anvendelse oral anvendelse intravenøs anvendelse
intravenous use oral use oral use oral use oral use
100 mg / ml 50 mg/ ml 2 mg / ml
2 mg / ml 500 mg 750 mg 50 mg/ ml 100 mg/ ml
6 Medlemsland
5 Member State
Ciproxina
CIPROXIN XR
400 mg/ 200 ml
500 mg
infusionsvæske, opløsning
modified release tablets
intravenøs anvendelse
oral use
2 mg / ml
500 mg
Ciprobay XR
CIPROXIN XR
tabletter med modificeret udløsning
modified release tablets
Ciproxin Ciproxin
Hungary
5 g/ 100 ml 10 g/ 100 ml
Bayer Hungária Kft.
Bayer HealthCare AG D- 513 68 Leverkusen
50.
Ciprobay
Ciprobay Hungary
250 mg
250 mg.
filmovertrukne tabletter
film-coated tablets film-coated tablets solution for infusion
oral anvendelse
oral use oral use intravenous use
250 mg
250 mg 500 mg 2 mg/ ml
500 mg
200 mg/ 100 ml 400 mg/ 200 ml
filmovertrukne tabletter
solution for infusion solution for infusion
oral anvendelse
intravenous use intravenous use
500 mg
2 mg/ ml 2 mg/ ml
Ciprobay
Iceland
750 mg
250 mg 500 mg 750 mg 200 mg/ 100 ml 400 mg/ 200 ml
filmovertrukne tabletter
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion
750 mg
250 mg 500 mg 750mg 2 mg/ ml 2 mg/ ml
Ciprobay
Ireland
100 mg/ 50 ml
100 mg 250 mg
infusionsvæske, opløsning
film-coated tablets film-coated tablets
intravenøs anvendelse
oral use use oral use use
2 mg/ ml
100 mg 250 mg
Ciprobay
Dublin 18, Ireland Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
200 mg/ 100 ml
500 mg 750 mg 250 mg/ 5 ml 500 mg/ 5 ml 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
infusionsvæske, opløsning
film-coated tablets film-coated tablets oral suspension oral suspension solution for infusion solution for infusion solution for infusion
intravenøs anvendelse
oral use use oral use use oral use use oral use use intravenous use intravenous use intravenous use
Ciprobay
Bayer HealthCare AG CIFLOX D-51368 Leverkusen, CIFLOX Germany
intravenøs anvendelse
oral use oral use
2 mg/ ml
250 mg 500 mg
Slovenien
Bayer S. p. A.
Ciprobay Ciprobay Ciprobay
CIPROXIN
Ciprobay Ciprobay
Pharmaceutical Form
200 mg/ 100 ml 400 mg/ 200 ml
Content (concentratio n)
infusionsvæske, opløsning infusionsvæske, opløsning
film-coated tablets film-coated tablets modified release tablets modified release tablets oral suspension oral suspension solution for infusion solution for infusion solution for infusion
intravenøs anvendelse intravenøs anvendelse
oral use oral use oral use oral use oral use oral use intravenous use intravenous use intravenous use
2 mg / ml 2 mg / ml
500 mg 750 mg 500 mg 1000 mg 50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
Quimica Farmacéutica Bayer, S: L.
BAYER SA-NV Ciproxine Avenue Louise 143 Ciproxine Louizalaan 143 Ciproxine B - 1050 Bruxelles-Brussel
250 mg 500 mg
100 mg/ 50 ml 100 mg 250 mg
filmovertrukne tabletter filmovertrukne tabletter
solution for infusion film-coated tablets film-coated tablets
oral anvendelse oral anvendelse
intravenous use oral use oral use
250 500 mg
2 mg/ ml 100 mg 250 mg
7 Medlemsland
Ciproxine Belgium
Indehaver af markedsføringstilladelsen
film-coated tablets
Særnavn
oral use
Styrke
500 mg
Lægemiddelform
Ciproxine Ciproxine Ciproxine Ciproxine
Administrationsvej
750 mg 5 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
Indhold (koncentratio n)
750 mg 250 mg/ 5 ml 2 mg/ ml 2 mg/ ml
Av.
Malta
BAYCIP BAYCIP BAYCIP
Bayer Plc Ciproxin Bayer House.
750 mg 250 mg 500 mg
250 mg 500 mg 100 mg/ 50 ml
filmovertrukne tabletter breve breve
film-coated tablets film-coated tablets solution for infusion
oral anvendelse oral anvendelse oral anvendelse
oral use oral use intravenous use
750 mg 250 mg 500 mg
250 mg 500 mg 2 mg/ ml
BAYCIP
Ciproxin United Kingdom
10 g/ 100 ml
200 mg/ 100 ml
suspension
solution for infusion
100 mg/ ml
2 mg/ ml
Sverige
Trading as:
Bayer HealthCare AG D- 513 68 Leverkusen
Bayer plc, Ciproxin Bayer Schering Pharma
Tyskland
Netherlands
500 mg
100 mg
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
7 Member State
750 mg 5 g/ 100 ml 10 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
Marketing Authorisation Invented name Holder
filmovertrukne tabletter suspension suspension infusionsvæske, opløsning infusionsvæske, opløsning
Strength
oral anvendelse oral anvendelse oral anvendelse intravenøs anvendelse intravenøs anvendelse
Pharmaceutical Form
750 mg 50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml
Route of administration
Storbritannien
Content (concentratio n)
Newbury Berkshire RG14 1JA
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
Ciproxin Ciproxin Ciproxin
250 mg 500 mg 750 mg 5 g/ 100 ml 10 g/ 100 ml 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
filmovertrukne tabletter filmovertrukne tabletter filmovertrukne tabletter
film-coated tablets film-coated tablets film-coated tablets oral suspension oral suspension solution for infusion solution for infusion solution for infusion
oral anvendelse oral anvendelse oral anvendelse
oral use oral use oral use oral use oral use intravenous use intravenous use intravenous use
100 mg 250 mg 500 mg
250 mg 500 mg 750 mg 50mg/ ml 100mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
Storbritannien
Norway