natgillin/translations-raw huggingface dataset:
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
Austria – Ciprofloxacin Hikma 200 mg/ 100 ml Infusionslösung Saksamaa – Ciprofloxacin Hikma 200 mg/ 100 ml Lösung zur Intravenösen Anwendung Iirimaa – Ciprofloxacin Hikma 200 mg/ 100 ml Solution for Infusion Itaalia – Ciprofloxacin Hikma 200 mg/ 100 ml Soluzione per Infusione Endovenosa Ühendkuningriik – Ciprofloxacin Hikma 200 mg/ 100 ml Solution for Infusion Madalmaad – Ciprofloxacine Hikma 200 mg/ 100 ml Oplossing voor Intraveneuze Infusie
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.
Ciprofloxacin Hikma sobib isotoonilise naatriumkloriidi, Ringeri või Ringer- laktaadi lahusega, 50 mg/ ml (5%) või 100 mg/ ml (10%) glükoosilahusega ja 50 mg/ ml (5%) glükoosilahusega, milles on 2, 24 mg/ ml (0, 225%) või 4, 5 mg/ ml (0, 45%) naatriumkloriidi lahust ja 10% fruktoosi lahusega.
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.
Kasutamisaegse keemilise ja füüsikalise stabiilsuse püsimine on tõestatud koheselt pärast lahjendamist, üle 24 h jooksul temperatuuril 2... 8 °C ja 24 h jooksul toatemperatuuril.
London, 11 July 2007 EMEA/ CHMP/ 75066/ 2007
London, 11. juuli 2007 EMEA/ CHMP/ 75066/ 2007
Ciprofloxacin
ARVAMUS PÄRAST ARTIKLI 29 LÕIKE 41 KOHAST ESILDIST, MIS KÄSITLES RAVIMIT Ciprofloxacin Hikma ja sarnased nimetused Rahvusvaheline mittekaubanduslik nimetus (INN): tsiprofloksatsiin
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.
Ciprofloxacin Hikma ja sarnased nimetused, 2 mg/ ml infusioonilahus, on antibiootikum, mis kuulub kinoloonide rühma, mis on in vitro tõhus paljude gramnegatiivsete aeroobsete bakterite ja mõnede grampositiivsete organismide vastu.
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.
Hikma Farmaceutica Lda. esitas taotluse Ciprofloxacin Hikma ja sarnaste nimetuste 2 mg/ ml infusiooni - lahuse vastastikuseks tunnustamiseks Madalmaade poolt 12. aprillil 2005 antud müügiloa alusel.
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).
Lisaks leiti, et taotleja peab lisama ravimi omaduste kokkuvõttesse (punkti 5. 1) piirväärtuste ja tundlikkuse tabelis nimetatud, näidustustega asjakohaste organismide loetelu, vastavalt bakterinakkuste raviks näidustatud ravimite hindamise suunistes (CPMP/ EWP/ 558/ 95 versioon 1) sätestatule.
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.
2007. aasta jaanuari koosolekul leidis inimtervishoius kasutatavate ravimite komitee, tuginedes kõigile esitatud andmetele ja komiteesisesele teaduslikule arutelule, et Ciprofloxacin Hikma ja sarnaste nimetuste kasulikkuse ja riski suhe on soodne, et tõstatatud küsimused ei saa olla müügiloa andmisel takistuseks ning et viiteliikmesriigi esitatud ravimi omaduste kokkuvõtet, märgistust ja pakendi infolehte tuleb muuta.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
RAVIMI NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE, TAOTLEJATE, MÜÜGILOA HOIDJATE LOETELU LIIKMESRIIKIDES
Marketing Authorisation Invented name Holder
Müügiloa hoidja
Bayer Austria GmbH Ciproxin Herbststraße 6-10 Ciproxin 1160 Wien Ciproxin Austria Ciproxin Ciproxin Ciproxin Ciprofloxacine « BAYER »
1160 Wien Austria
250 mg 500 mg 750 mg 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml 200 mg/ 100 ml
100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml 200 mg/ 100 ml
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion solution for infusion solution for infusion
infusioonilahus infusioonilahus infusioonilahus infusioonilahus
oral use oral use oral use intravenous use intravenous use intravenous use intravenous use
intravenoosne intravenoosne intravenoosne intravenoosne
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
2 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
Ciprofloxacine « BAYER
Ciprofloxacine « BAYER »
solution for infusion
infusioonilahus
oral suspension oral suspension
suukaudne suspensioon suukaudne suspensioon
oral use oral use
suukaudne suukaudne
BAYER SA-NV Ciproxine Avenue Louise 143 Ciproxine Louizalaan 143 Ciproxine B - 1050 Bruxelles-Brussel Ciproxine Belgium
Ciproxine Ciproxine Ciproxine
200 mg/ 100 ml 100 mg/ 50 ml 100 mg 250 mg
200 mg/ 100 ml 100 mg/ 50 ml 100 mg
solution for infusion solution for infusion film-coated tablets film-coated tablets
infusioonilahus infusioonilahus õhukese polümeerikattega
intravenous use intravenous use oral use oral use
intravenoosne intravenoosne suukaudne
2 mg/ ml 2 mg/ ml 100 mg 250 mg
2 mg/ ml 2 mg/ ml 100 mg
500 mg 750 mg 5 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
B - 1050 Bruxelles- Brussel
500 mg 750 mg 50 mg/ ml 2 mg/ ml 2 mg/ ml
tabletid
Bayer HealthCare AG Ciprobay D-51368 Leverkusen
Ciproxine
Germany Ciprobay
Ciproxine
Ciprobay
Bayer HealthCare AG D- 51368 Leverkusen
200 mg / 100 ml
250 mg
solution for infusion
õhukese polümeerikattega tabletid
intravenous use
suukaudne
2 mg/ ml
200 mg / 100 ml
modified release tablets
toimeainet modifitseeritult vabastavad tabletid
BAYER HELLAS ABEE, Greece 18-20 Sorou Street, 15125 Marousi, Athens, Greece
18- 20 Sorou Street, 15125 Marousi, Athens,
Ciproxin Ciproxin Ciproxin
Ciproxin
250 mg 500 mg 200 mg/ 100 ml
500 mg
film-coated tablets film-coated tablets solution for infusion
õhukese polümeerikattega tabletid
oral use oral use intravenous use
suukaudne
250 mg 500 mg 2 mg/ ml
500 mg
Czech Republic
intravenoosne
Bayer HealthCare AG D-51368 Leverkusen
Tšehhi Vabariik
solution for infusion
400 mg/ 200 ml
Ciprobay Uro Ciprobay Ciprobay Ciprobay
õhukese polümeerikattega tabletid
100 mg 250 mg 500 mg 750 mg
750 mg
film-coated tablets film-coated tablets film-coated tablets film-coated tablets
infusioonilahus infusioonilahus suukaudne suspensioon suukaudne suspensioon
oral use oral use oral use oral use
intravenoosne intravenoosne suukaudne suukaudne
100 mg 250 mg 500 mg 750 mg
2 mg/ ml 2 mg/ ml 50 mg/ ml 100 mg/ ml
Bayer HealthCare AG D-51368 Leverkusen
Bayer HealthCare AG D- 51368 Leverkusen
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
Ciproxin Ciproxin
750 mg 200 mg/ 100 ml 400 mg/ 200 ml 50 mg/ ml 100 mg/ ml
200 mg/ 100 ml 400 mg/ 200 ml
film-coated tablets solution for infusion solution for infusion oral suspension oral suspension
infusioonilahus infusioonilahus
oral use intravenous use intravenous use oral use oral use
intravenoosne intravenoosne
750 mg 2 mg/ ml 2 mg/ ml 50 mg/ ml 100 mg/ ml
2 mg/ ml 2 mg/ ml
Bayer HealthCare AG D-51368 Leverkusen
Bayer HealthCare AG 51368 Leverkusen,
film-coated tablets film-coated tablets
õhukese polümeerikattega tabletid
oral use oral use
suukaudne
3 Member State
Ciproxin
Marketing Authorisation Invented name Holder
õhukese polümeerikattega tabletid
Strength
suukaudne
Pharmaceutical Form
Ciproxin
Route of administration
õhukese polümeerikattega tabletid
Content (concentratio n)
suukaudne
Germany Ciproxin Ciproxin
Ciproxin Ciproxin
solution for infusion solution for infusion
infusioonilahus infusioonilahus
intravenous use intravenous use
intravenoosne intravenoosne
Bayer HealthCare AG Ciproxin 51368 Leverkusen, Ciproxin Germany Ciproxin Ciproxin Ciproxin
Bayer Santé 13, rue Jean Jaurès
250 mg 500 mg 750 mg 200 mg/ 100 ml 400 mg/ 200 ml
250 mg
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion
õhukese polümeerikattega tabletid
oral use oral use oral use intravenous use intravenous use
suukaudne
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml
250 mg
France
Ciflox
Bayer Santé Ciflox 13, rue Jean Jaurès Ciflox 92807 Puteaux Cedex Uniflox France
õhukese polümeerikattega tabletid
250 mg 500 mg 500 mg
500 mg
film-coated tablets film-coated tablets film-coated tablets
õhukese polümeerikattega tabletid
oral use oral use oral use
suukaudne
Ciflox Ciflox Ciflox Ciflox Ciflox
Ciflox Ciflox Ciflox
750 mg 250 mg/ 5 ml 500 mg/ 5 ml 200 mg/ 100 ml 400 mg/ 200 ml
250 mg/ 5 ml 500 mg/ 5 ml 200 mg/ 100 ml
film-coated tablets oral suspension oral suspension solution for infusion solution for infusion
suukaudne suspensioon suukaudne suspensioon infusioonilahus
oral use oral use oral use intravenous use intravenous use
suukaudne suukaudne intravenoosne
750 mg 50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml
50 mg/ ml 100 mg/ ml 2 mg/ ml
Germany
Tugevus
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
CIPROBAY CIPROBAY CIPROBAY CIPROBAY URO
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
100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml 100 mg
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
infusioonilahus infusioonilahus infusioonilahus õhukese polümeerikattega tabletid
intravenous use intravenous use intravenous use oral use oral use oral use oral use oral use oral use oral use
intravenoosne intravenoosne intravenoosne suukaudne
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
2 mg/ ml 2 mg/ ml 2 mg/ ml 100 mg
Germany Ciprofloxacin ANTIBAC
õhukese polümeerikattega tabletid
4 Member State
CIPROBAY
Pharmaceutical Form
suukaudne suukaudne
Route of administration
Ciprofloxacin ANTIBAC
Content (concentratio n)
Ciprofloxacin ANTIBAC
BAYER HELLAS ΑΒΕΕ CIPROXIN 18-20 Sorou Street
BAYER HELLAS ΑΒΕΕ 18- 20 Sorou Street
15125 Marousi, Athens, CIPROXIN Greece
15125 Marousi, Athens, Kreeka
CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN
CIPROXIN CIPROXIN
400 mg/ 200 ml 500 mg 750 mg 250 mg/ 5 ml 500 mg/ 5 ml
400 mg/ 200 ml 500 mg
solution for infusion film-coated tablets film-coated tablets oral suspension oral suspension
infusioonilahus õhukese polümeerikattega tabletid
intravenous use oral use oral use oral use oral use
intravenoosne suukaudne
2 mg / ml 500 mg 750 mg 50 mg/ ml 100 mg/ ml
2 mg / ml 500 mg
5 Member State
CIPROXIN
Strength
750 mg
Pharmaceutical Form
õhukese polümeerikattega tabletid
Route of administration
suukaudne
Content (concentratio n)
750 mg
CIPROXIN XR
CIPROXIN CIPROXIN CIPROXIN XR
500 mg
250 mg/ 5 ml 500 mg/ 5 ml 500 mg
modified release tablets
suukaudne suspensioon suukaudne suspensioon toimeainet modifitseeritult vabastavad tabletid
oral use
suukaudne suukaudne suukaudne
500 mg
50 mg/ ml 100 mg/ ml 500 mg
Ciprobay H-1123 Budapest Ciprobay Alkotás u.
H- 1123 Budapest
Ciprobay Hungary
Bayer Healthcare AG 51368 Leverkusen,
250 mg.
250 mg
500 mg 100 mg/ 50 ml
500 mg
Ciprobay Ciprobay
Ciproxin
200 mg/ 100 ml 400 mg/ 200 ml
750 mg
solution for infusion solution for infusion
õhukese polümeerikattega tabletid
intravenous use intravenous use
suukaudne
2 mg/ ml 2 mg/ ml
750 mg
Bayer Healthcare AG Ciproxin 51368 Leverkusen, Ciproxin Germany Ciproxin Ciproxin Ciproxin
Ciproxin Ciproxin
250 mg 500 mg 750 mg 200 mg/ 100 ml 400 mg/ 200 ml
200 mg/ 100 ml 400 mg/ 200 ml
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion
infusioonilahus infusioonilahus
oral use oral use oral use intravenous use intravenous use
intravenoosne intravenoosne
250 mg 500 mg 750mg 2 mg/ ml 2 mg/ ml
2 mg/ ml 2 mg/ ml
Bayer Limited Ciproxin The Atrium, Ciproxin Blackthorn Road,
Bayer Limited The Atrium,
100 mg 250 mg
100 mg
oral use use oral use use
suukaudne
Dublin 18, Ireland Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
Blackthorn Road, Dublin 18,
500 mg 750 mg 250 mg/ 5 ml 500 mg/ 5 ml 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
250 mg/ 5 ml 500 mg/ 5 ml 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
film-coated tablets film-coated tablets oral suspension oral suspension solution for infusion solution for infusion solution for infusion
suukaudne suspensioon suukaudne suspensioon infusioonilahus infusioonilahus infusioonilahus
oral use use oral use use oral use use oral use use intravenous use intravenous use intravenous use
suukaudne suukaudne intravenoosne intravenoosne intravenoosne
500 mg 750 mg 50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
Bayer HealthCare AG CIFLOX D-51368 Leverkusen, CIFLOX Germany
Bayer HealthCare AG D- 51368 Leverkusen,
film-coated tablets film-coated tablets
suukaudne
250 mg 500 mg
500 mg
6 Member State
7 Liikmesriik
Viale Certosa 130 CIPROXIN I-20156 Milan CIPROXIN Italy CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN Not authorised Not authorised
CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN
500 mg 750 mg 500 mg 1000 mg 250 mg 500 mg 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
250 mg 500 mg 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
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
suukaudne suspensioon suukaudne suspensioon infusioonilahus infusioonilahus infusioonilahus
oral use oral use oral use oral use oral use oral use intravenous use intravenous use intravenous use
suukaudne suukaudne intravenoosne intravenoosne intravenoosne
500 mg 750 mg 500 mg 1000 mg 50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
BAYER SA-NV Ciproxine Avenue Louise 143 Ciproxine Louizalaan 143 Ciproxine B - 1050 Bruxelles-Brussel
BAYER SA- NV Avenue Louise 143 Louizalaan 143
100 mg/ 50 ml 100 mg 250 mg
100 mg/ 50 ml 100 mg
solution for infusion film-coated tablets film-coated tablets
intravenoosne suukaudne
intravenous use oral use oral use
suukaudne
2 mg/ ml 100 mg 250 mg
250 mg
Ciproxine Belgium
Ciproxine
Ciproxine Ciproxine Ciproxine Ciproxine
Ciproxine Ciproxine Ciproxine
750 mg 5 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
5 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
film-coated tablets oral suspension solution for infusion solution for infusion
suukaudne suspensioon infusioonilahus infusioonilahus
oral use oral use intravenous use intravenous use
suukaudne intravenoosne intravenoosne
750 mg 250 mg/ 5 ml 2 mg/ ml 2 mg/ ml
250 mg/ 5 ml 2 mg/ ml 2 mg/ ml
Bayer Plc Ciproxin Bayer House.
Bayer Plc Bayer House.
Ciproxin Newbury Ciproxin Berkshire RG14 1JA
Newbury Berkshire RG14 1JA
250 mg 500 mg 100 mg/ 50 ml
500 mg
Ciproxin United Kingdom
Ciproxin Ciproxin
200 mg/ 100 ml
100 mg/ 50 ml 200 mg/ 100 ml
solution for infusion
2 mg/ ml 2 mg/ ml
intravenous use
Ravimi nimetus
2 mg/ ml
Tugevus
Trading as:
Ravimvorm
Bayer plc, Ciproxin Bayer Schering Pharma
Bayer Schering Pharma
Bayer BV Ciproxin
Ciproxin
7 Member State
Ciproxin
Content (concentratio n)
õhukese polümeerikattega tabletid
Ciproxin Ciproxin 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
5 g/ 100 ml 10 g/ 100 ml 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
film-coated tablets film-coated tablets film-coated tablets oral suspension oral suspension solution for infusion solution for infusion solution for infusion
suukaudne suspensioon suukaudne suspensioon infusioonilahus infusioonilahus infusioonilahus
oral use oral use oral use oral use oral use intravenous use intravenous use intravenous use
suukaudne suukaudne intravenoosne intravenoosne intravenoosne
250 mg 500 mg 750 mg 50mg/ ml 100mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml 2 mg/ ml
Bayer HealthCare AG Ciproxin D-513 68 Leverkusen Ciproxin Germany Ciproxin Ciproxin Ciproxin
Bayer HealthCare AG D- 513 68 Leverkusen
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml
2 mg/ ml 2 mg/ ml
Bayer HealthCare AG Ciprobay Uro D-51368 Leverkusen Ciprobay Germany Ciprobay Ciprobay Ciprobay Ciprobay
Bayer HealthCare AG D- 51368 Leverkusen
100 mg 250 mg 500 mg 100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml
100 mg/ 50 ml 200 mg/ 100 ml
film-coated tablet film-coated tablet film-coated tablet solution for infusion solution for infusion solution for infusion
infusioonilahus õhukese polümeerikattega tabletid
oral use oral use oral use intravenous use intravenous use intravenous use
intravenoosne suukaudne
100 mg 250 mg 500 mg 2 mg/ ml 2 mg/ ml 2 mg/ ml
2 mg/ ml 250 mg
Portugal
suukaudne
Ciproxina Rua Quinta do Ciproxina Pinheiro 5 Ciproxina 2794-003 Carnaxide
Ciproxina
250 mg 500 mg 750 mg
750 mg
Ciproxina OD Portugal
Ciproxina OD
Ciproxina OD Ciproxina Ciproxina Ciproxina
Ciproxina Ciproxina Ciproxina Ciproxina
1000 mg 10 g/ 100 ml 5 g/ 100 ml 200 mg/ 100 ml
10g/ 100 ml 5 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
modified release tablets oral suspension oral suspension solution for infusion
suukaudne suspensioon suukaudne suspensioon infusioonilahus infusioonilahus
oral use oral use oral use intravenous use
suukaudne suukaudne intravenoosne intravenoosne
1000 mg 100 mg/ ml 50 mg/ ml 2 mg / ml
100 mg / ml 50 mg/ ml 2 mg / ml 2 mg / ml
8 Member State
Rumeenia
Marketing Authorisation Invented name Holder
Bayer HealthCare AG D- 51368 Leverkusen
Strength
Ciprobay
Pharmaceutical Form
500 mg
Ciproxina
Saksamaa
400 mg/ 200 ml
200 mg/ 100 ml 400 mg/ 200 ml 500 mg
solution for infusion
2 mg/ ml 2 mg/ ml 500 mg
intravenous use
Ciprobay XR
2 mg / ml
1000 mg
Romania
1000 mg
Bayer HealthCare AG Ciprobay D-51368 Leverkusen Ciprobay Germany Ciprobay Ciprobay XR Ciprobay XR Ciproxin Ciproxin
Ciproxin Ciproxin
500 mg 200 mg/ 100 ml 400 mg/ 200 ml 500 mg 1000 mg 5 g/ 100 ml 10 g/ 100 ml
5 g/ 100 ml 10 g/ 100 ml
film-coated tablets solution for infusion solution for infusion modified release tablets modified release tablets oral suspension oral suspension
suukaudne suspensioon suukaudne suspensioon
oral use intravenous use intravenous use oral use oral use oral use oral use
suukaudne suukaudne
500 mg 2 mg/ ml 2 mg/ ml 500 mg 1000 mg 50 mg/ ml 100 mg/ ml
50 mg/ ml 100 mg/ ml
Bayer HealthCare AG Ciprobay D-51368 Leverkusen
Bayer HealthCare AG D- 51368 Leverkusen
film-coated tablet
õhukese polümeerikattega tabletid
Germany Ciprobay
Ciprobay
Bayer Pharma, d. o. o., Bravnič arjeva 13 SI-1000 Ljubljana Slovenia
Bayer Pharma, d. o. o., Bravničarjeva 13
Ciprobay Ciprobay Ciprobay Ciprobay Ciprobay
õhukese polümeerikattega tabletid
250 mg 500 mg 750 mg 200 mg/ 100 ml 400 mg/ 200 ml
500 mg
film-coated tablet film-coated tablet film-coated tablet solution for infusion solution for infusion
õhukese polümeerikattega tabletid
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml
500 mg
Spain
750 mg
Química Farmacéutica Bayer, S. L.
750 mg
Baix Llobregat, 3-5
Baix Llobregat, 3- 5 - 08970 Sant Joan Despí -
BAYCIP BAYCIP BAYCIP
BAYCIP
250 mg 500 mg 750 mg
500 mg
9 Member State
Barcelona Hispaania
Marketing Authorisation Invented name Holder
BAYCIP
08970 Sant Joan Despí BAYCIP Barcelona
BAYCIP
oral suspension (in single dose sachets)
suukaudne suspensioon (üheannuselistes pakikestes)
Spain BAYCIP
BAYCIP
Bayer HealthCare AG Ciproxin D-51368 Leverkusen
Bayer HealthCare AG D- 51368 Leverkusen
Germany Ciproxin
Ciproxin
Ciproxin 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
5 g/ 100 ml 10 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
film-coated tablet oral suspension oral suspension solution for infusion solution for infusion
suukaudne suspensioon suukaudne suspensioon infusioonilahus infusioonilahus
oral use oral use oral use intravenous use intravenous use
suukaudne suukaudne intravenoosne intravenoosne
750 mg 50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml
50 mg/ ml 100 mg/ ml 2 mg/ ml 2 mg/ ml
film-coated tablet film-coated tablet film-coated tablet
õhukese polümeerikattega tabletid
United Kingdom
Ühendkuningriik Ärinimi:
oral suspension oral suspension solution for infusion solution for infusion solution for infusion
suukaudne suspensioon suukaudne suspensioon infusioonilahus infusioonilahus infusioonilahus
oral use oral use intravenous use intravenous use intravenous use
suukaudne suukaudne intravenoosne intravenoosne intravenoosne
10 ANNEX II
12 II LISA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
EUROOPA RAVIMIAMETI ESITATUD TEADUSLIKUD JÄRELDUSED NING RAVIMI OMADUSTE KOKKUVÕTTE, MÄRGISTUSE JA PAKENDI INFOLEHE MUUTMISE ALUSED
11 SCIENTIFIC CONCLUSIONS
13 TEADUSLIKUD JÄRELDUSED
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.
Seega on tegemist mitmete erinevate täiskasvanutel esinevate nakkustega.
The following oral and intravenous formulations are currently approved and marketed in different EU countries:
Praegu on mitmes Euroopa Liidu riigis heaks kiidetud ning müügil järgmised suukaudsed ja intravenoossed ravimvormid:
- Immediate release film-coated tablets:
- toimeainet kiiresti vabastavad õhukese polümeerikattega tabletid:
100 mg, 250 mg, 500 mg, 750 mg
100 mg, 250 mg, 500 mg, 750 mg;
- Granules and solvent for oral suspension:
- suukaudse suspensiooni graanulid ja lahusti:
250 mg/ 5 ml, 500 mg/ 5 ml
250 mg / 5 ml, 500 mg / 5 ml;
- Solution for infusion (glass bottles and flexibags):
- infusioonilahus (klaaspudelites ja elastsetes infusioonikottides):
100 mg/ 50 ml, 200 mg/ 100 ml and 400 mg/ 200 ml
100 mg / 50 ml, 200 mg / 100 ml ja
- Modified release film-coated tablets:
- toimeainet modifitseeritult vabastavad õhukese polümeerikattega tabletid:
500 mg, 1000 mg.
500 mg, 1000 mg;
- Sachets:
- kotikesed:
250mg, 500mg
250 mg, 500 mg.
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.
Ravimi omaduste kokkuvõtte lõik 4. 1 „ Näidustused “ Üldiselt pööras inimravimite komitee selle lõigu kooskõlastamisel iga näidustuse puhul erilist tähelepanu olemasolevale teabele tsiprofloksatsiini resistentsuse kohta.
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.
Esitatud andmete kohaselt on ravimi tõhusus sellel näidustusel halvasti põhjendatud.