natgillin/translations-raw huggingface dataset:
- altered vision such as double vision (diplopia) and seeing all objects in a certain colour (chromatopsia)
- spremembe vida, kot je dvojni vid (diplopija) in videnje predmetov v določeni barvi
- ringing in the ear (tinnitus), transient hearing loss (particularly high frequencies)
(kromatopsija);
- increased heart rate (tachycardia)
- zvenenje v ušesu (tinitus), prehodna izguba sluha (zlasti visokih frekvenc);
- fainting (syncope), widening of blood vessel (vasodilation)
- pospešen srčni utrip (tahikardija);
- shortness of breath (dyspnoea), swelling of the voice box (larynx) with difficulties in breathing
- omedlevica (sinkopa), širjenje krvnih žil (vazodilatacija);
(larynx oedema)
- zasoplost (dispneja), otekanje grla (larinksa) s težavami pri dihanju (edem grla);
- severe and continuous diarrhoea, possibly with blood and mucus, due to a severe inflammation of the
- huda in neprekinjena driska, s krvjo in sluzjo ali brez njiju, zaradi hudega vnetja debelega črevesa
large intestine (pseudo membranous colitis), fungal infection in the mouth (oral moniliasis)
(psevdomembranski kolitis), glivična okužba v ustih (oralna kandidoza);
- yellowing of the skin or whites of the eyes (icterus), icterus due to a condition where the bile can not
- porumenelost kože in beločnic (ikterus), zlatenica zaradi bolezni, pri kateri žolč ne more normalno
flow normally from the liver (cholestatic icterus), liver cell necrosis
teči iz jeter (holestatski ikterus), nekroza jetrnih celic;
- increased sensitivity to light (photosensitivity), erythema multiforme and erythema nodusum
- povečana občutljivost za svetlobo (fotosenzitivnost), multiformni eritem in nodozni eritem;
- muscular pain (myalgia), joint disorder (swollen joints)
- bolečine v mišicah (mialgija), bolezni sklepov (otekanje sklepov);
- acute kidney failure, abnormal kidney function, vaginal secretion due to a fungal infection (vaginal
- akutna ledvična odpoved, nenormalno delovanje ledvic, izcedek iz nožnice zaradi glivične okužbe
moniliasis), blood in the urine (haematuria), presence of crystals in the urine with discomfort when passing urine (crystalluria), infection of the kidney with blood in the urine, fever and pain in the side (interstitial nephritis)
(vaginalna kandidoza), kri v urinu (hematurija), prisotnost kristalov v urinu z neprijetnim občutkom pri uriniranju (kristalurija), vnetje ledvic s krvjo v urinu, zvišano telesno temperaturo in stransko bolečino (intersticijski nefritis);
- perspiration
- potenje.
- reduction in red blood cells due to extensive destruction of these cells (haemolytic anaemia), severe
- zmanjšanje števila eritrocitov zaradi njihovega obsežnega uničenja (hemolitična anemija), hudo
reduction in blood cells (pancytopenia), severe reduction in white blood cells characterised by sudden high fever, very sore throat and mouth ulcers (agranulocytosis)
zmanjšanje števila krvnih celic (pancitopenija), hudo zmanjšanje števila levkocitov, za katero so značilni nenadna zelo zvišana telesna temperatura, zelo boleče grlo in razjede v ustih (agranulocitoza);
- a life-threatening condition characterised by a sharp drop in the blood pressure, paleness, restlessness,
- smrtno nevarna bolezen, za katero so značilni nenadno znižanje krvnega tlaka, bledica, nemir,
weak/ quick pulse, clammy skin, dizziness as a result of severe allergy to this medicine (anaphylactic shock), itching rash, fever, joint swellings, muscle pains, rash (symptoms similar to those occurring in a disease called serum sickness)
28 (anafilaktični šok), srbeči izpuščaj, zvišana telesna temperatura, otekanje sklepov, bolečine v mišicah, izpuščaj (simptomi, podobni tistim, ki se pojavijo pri bolezni, imenovani serumska bolezen);
- disturbed control of own behaviour and actions (psychotic reactions which may progress to self-
- moten nadzor nad lastnim vedenjem in delovanjem (psihotične reakcije, ki lahko napredujejo do
endangering behaviour)
samomorilskega vedenja);
- smell disorder (parosmia), loss of smell (anosmia, the smell usually returns after termination of
- motnje voha (parozmija), izguba voha (anozmija, voh se po navadi povrne po končanem
treatment), convulsions (grand mal convulsion), abnormal (unstable) gait, increased pressure in the head (intracranial hypertension), lack of coordination (ataxia), increased sensitivity to stimulation (hyperaesthesia), stiffness (hypertonia)
zdravljenju), epileptični napadi (generalizirani), nenormalna (nestabilna) hoja, zvišan tlak v glavi (intrakranialna hipertenzija), pomanjkanje koordinacije (ataksija), povečana občutljivost za dražljaje (hiperestezija), otrdelost (hipertonija);
- irregular heart beat (ventricular arrhythmia), abnormal electrocardiogram heart tracing, life-
- nereden srčni utrip (ventrikularna aritmija), nenormalni elektrokardiogram, smrtno nevaren
threatening increased heart rate (torsade de pointes).
pospešen utrip (aritmija "torsade de pointes").
These side effects occur predominantly in patients at risk for certain heart disorders.
Ti neželeni učinki se pojavljajo večinoma pri bolnikih s tveganjem za nekatere bolezni srca;
- inflammation of blood vessels (vasculitis) characterised by: small spots caused by bleeding in the skin
- vnetje krvnih žil (vaskulitis), za katerega so značilni naslednji znaki: majhne pike, ki jih
(petechiae), bloody blisters (haemorrhagic bullae), skin nodes (papules), formation of eschar (dead tissue that sheds (sloughs-off) from healthy skin)
povzročajo krvavitve v koži (petehije), krvavi mehurji (hemoragične bule), kožne bunčice (papule), tvorba eshar (mrtvega tkiva, ki odpada (se lušči) z zdrave kože);
- fungal infection in the gastrointestinal system (gastrointestinal moniliasis), pancreas inflammation
- glivične okužbe prebavil (gastrointestinalna kandidoza), vnetje trebušne slinavke (pankreatitis);
- liver inflammation (hepatitis), destruction of liver tissue (liver cell necrosis, very rarely resulting in life-
- vnetje jeter (hepatitis), razkroj jetrnega tkiva (nekroza jetrnih celic, zelo redko lahko povzroči
threatening liver failure)
smrtno nevarno jetrno odpoved);
- rash with red (moist) irregular spots (erythema (exsudativum) multiforme), tender bluish red bumps in
- izpuščaj z rdečimi (vlažnimi) nepravilnimi pikami (multiformni (eksudativni) eritem), boleče
the skin (erythema nodosum), severe condition with (high) fever, red spots on the skin, joint pains and/ or eye infection (Stevens-Johnson syndrome), severe condition with fever and blisters on the skin/ peeling of the skin (Lyell syndrome), small purplish red spot (petechia)
modrikasto- rdeče izbokline na koži (nodozni eritem), huda bolezen z (zelo) zvišano telesno temperaturo, rdečimi pikami na koži, bolečino v sklepih in/ ali okužbo oči (Stevens- Johnsonov sindrom), huda bolezen z zvišano telesno temperaturo in mehurji na koži/ luščenjem kože (Lyellov sindrom), majhne vijoličasto- rdeče pike (petehija);
- inflammation of the tendons (tendinitis, in particular of the Achilles tendon), partial or total tendon
- vnetje kit (tendinitis, zlasti ahilove kite), delno ali celotno pretrganje kit (zlasti ahilove kite),
ruptures (in particular of the Achilles tendon), exacerbation of the symptoms of myasthenia gravis (a particular type of muscle weakness), muscular pains, inflammation of tendon sheaths (tenosynovitis)
poslabšanje simptomov miastenije gravis (posebne vrste mišične šibkosti), bolečine v mišicah, vnetje ovojnic kit (tendosinovitis);
- increased blood level of amylase (enzyme that breaks down starch) and lipase (enzyme that breaks
- zvišana raven amilaze (encima, ki razgrajuje škrob) in lipaze (encima, ki razgrajuje maščobe) v
down fats).
krvi;
- weakness (asthenia), a transient impairment of kidney function to transient renal failure, photosensitivy.
- šibkost (astenija), prehodno poslabšanje delovanja ledvic do prehodne ledvične odpovedi,
HOW TO STORE CIPROFLOXACIN HIKMA
SHRANJEVANJE ZDRAVILA CIPROFLOXACIN HIKMA
Do not use Ciprofloxacin Hikma after the expiry date which is stated on the packaging after “ Exp”.
Zdravila Ciprofloxacin Hikma ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake Uporabno do.
• Do not refrigerate or freeze. • Keep the vial in the outer carton until time of use in order to protect from light.
• Ne shranjujte v hladilniku ali zamrzujte. • Vialo do uporabe shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
What Ciprofloxacin Hikma contains
Kaj vsebuje zdravilo Ciprofloxacin Hikma Zdravilna učinkovina je ciprofloksacinlaktat.
Each vial of 100 ml contains 200 mg of ciprofloxacin.
Vsaka 100- mililitrska viala vsebuje 200 mg ciprofloksacina.
What Ciprofloxacin Hikma looks like and contents of the pack Ciprofloxacin Hikma is a sterile, clear and colourless to slightly yellow solution for infusion.
29 Zdravilo Ciprofloxacin Hikma je sterilna, bistra in brezbarvna do rahlo rumena raztopina za infundiranje.
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
Estrada do Rio da Mó n. o 8, 8A e 8B – Fervença 2705- 906 Terrugem SNT Portugalska Tel.: +351 219 608 410 Faks: +351 219 615 102 geral@ hikma. pt
This medicinal product is authorised in the Member States of EEA under the following names:
Zdravilo je pridobilo dovoljenje za promet v državah članicah EGP pod naslednjimi imeni:
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
Avstrija – Ciprofloxacin Hikma 200 mg/ 100 ml Infusionslösung Nemčija – Ciprofloxacin Hikma 200 mg/ 100 ml Lösung zur Intravenösen Anwendung Irska – Ciprofloxacin Hikma 200 mg/ 100 ml Solution for Infusion Italija – Ciprofloxacin Hikma 200 mg/ 100 ml Soluzione per Infusione Endovenosa Velika Britanija – Ciprofloxacin Hikma 200 mg/ 100 ml Solution for Infusion Nizozemska – 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.
Zdravilo Ciprofloxacin Hikma je združljivo z izotonično raztopino natrijevega klorida, Ringerjevo raztopino, raztopino Ringerjevega laktata, 5- odstotno (50 mg/ ml) ali 10- odstotno (100 mg/ ml) raztopino glukoze in 5- odstotno (50 mg/ ml) raztopino glukoze z 0, 225- odstotno (2. 25 mg/ ml) ali 0, 45 - odstotno (4, 5 mg/ ml) raztopino natrijevega klorida in 10- odstotno raztopino fruktoze.
London, 11 July 2007 EMEA/ CHMP/ 75066/ 2007
London, 11. julij 2007 EMEA/ CHMP/ 75066/ 2007
Ciprofloxacin
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA zdravilo Ciprofloxacin Hikma in z njim povezana imena Mednarodno nelastniško ime (INN): ciprofloksacin
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.
Zdravilo Ciprofloxacin Hikma in z njim povezana imena, 2 mg/ ml raztopina za infundiranje, je antibiotik, ki sodi v družino kinolonov in je in vitro učinkovit proti številnim po Gramu negativnim aerobnim bakterijam kakor tudi proti nekaterim po Gramu pozitivnim organizmom.
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.
Podjetje Hikma Farmaceutica Lda. je predložilo vloge za medsebojno priznavanje dovoljenja za zdravilo Ciprofloxacin Hikma in z njim povezana imena, 2 mg/ ml raztopino za infundiranje, na podlagi dovoljenja za promet, podeljenega na Nizozemskem 12. aprila 2005.
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).
Poleg tega je bilo ocenjeno, da bi moral predlagatelj v povzetek glavnih značilnosti zdravila (poglavje 5. 1) vključiti organizme, naštete v mejnih vrednostih in tabeli občutljivosti, ki se nanašajo na indikacije, kot je bilo določeno v navodilih za vrednotenje zdravil, indiciranih za zdravljenje bakterijskih okužb (Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections, CPMP/ EWP/ 558/ 95 rev. 1).
The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Poročevalec je bil dr.
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.
Med svojim zasedanjem januarja 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Ciprofloxacin Hikma in z njim povezana imena ugodno, da naj podani ugovori ne preprečijo podelitve dovoljenja za promet z zdravilom ter da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice dopolniti.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Znanstveni zaključki so podani v Dodatku II, skupaj z dopolnjenim povzetkom glavnih značilnosti zdravila v Dodatku III.
The final opinion was converted into a Decision by the European Commission on 11 July 2007.
11.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Marketing Authorisation Invented name Holder
Imetnik dovoljenja za promet z zdravilom
Content (concentratio n)
Vsebina (koncentracij a)
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion solution for infusion solution for infusion
filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete raztopina za infundiranje raztopina za infundiranje raztopina za infundiranje raztopina za infundiranje
oral use oral use oral use intravenous use intravenous use intravenous use intravenous use
peroralna uporaba peroralna uporaba peroralna uporaba intravenska uporaba intravenska uporaba intravenska uporaba intravenska uporaba
solution for infusion
raztopina za infundiranje
intravenous use
intravenska uporaba
oral suspension oral suspension
peroralna suspenzija peroralna suspenzija
oral use oral use
peroralna uporaba peroralna uporaba
BAYER SA-NV Ciproxine Avenue Louise 143 Ciproxine Louizalaan 143 Ciproxine B - 1050 Bruxelles-Brussel Ciproxine Belgium
BAYER SA- NV Avenue Louise 143 Louizalaan 143
solution for infusion solution for infusion film-coated tablets film-coated tablets
raztopina za infundiranje raztopina za infundiranje filmsko obložene tablete
intravenous use intravenous use oral use oral use
intravenska uporaba intravenska uporaba peroralna uporaba
500 mg 750 mg 50 mg/ ml 2 mg/ ml 2 mg/ ml
B - 1050 Bruxelles- Brussel Belgija
Bulgaria
Ciproxine
film-coated tablets
Ciproxine Ciproxine Ciproxine Ciproxine Ciproxine
200 mg / 100 ml
500 mg 750 mg 5 g/ 100 ml 200 mg/ 100 ml 400 mg/ 200 ml
solution for infusion
filmsko obložene tablete filmsko obložene tablete peroralna suspenzija raztopina za infundiranje raztopina za infundiranje
intravenous use
peroralna uporaba peroralna uporaba peroralna uporaba intravenska uporaba intravenska uporaba
2 mg/ ml
500 mg 750 mg 50 mg/ ml 2 mg/ ml 2 mg/ ml
2 Member State
Bolgarija
Marketing Authorisation Invented name Holder
Bayer HealthCare AG D- 51368 Leverkusen Nemčija
Ciprobay
Ciprobay Ciprobay Ciprobay Ciprobay Ciprobay XR
400 mg/ 200 ml
250 mg 500 mg 200 mg / 100 ml 400 mg/ 200 ml 500 mg
solution for infusion
filmsko obložene tablete filmsko obložene tablete raztopina za infundiranje raztopina za infundiranje tablete s prirejenim sproščanjem
intravenous use
peroralna uporaba peroralna uporaba intravenska uporaba intravenska uporaba peroralna uporaba
2 mg/ ml
250 mg 500 mg 2 mg/ ml 2 mg/ ml 500 mg
500 mg
Ciper
BAYER HELLAS ABEE, Greece 18-20 Sorou Street, 15125 Marousi, Athens, Greece
BAYER HELLAS ABEE, Greece
film-coated tablets film-coated tablets solution for infusion
filmsko obložene tablete filmsko obložene tablete
oral use oral use intravenous use
peroralna uporaba peroralna uporaba
250 mg 500 mg 2 mg/ ml
2
Bayer HealthCare AG D-51368 Leverkusen
Imetnik dovoljenja za promet z zdravilom
Ciprobay
Izmišljeno ime
100 mg/ 50 ml
Jakost
solution for infusion
Farmacevtska oblika
2 mg/ ml
Vsebina (koncentracij a)
Germany
18- 20 Sorou Street, 15125 Marousi, Athens, Grčija
Ciprobay
Ciproxin
Ciprobay
Češka
solution for infusion
Bayer HealthCare AG D- 51368 Leverkusen Nemčija
Ciprobay Uro Ciprobay Ciprobay Ciprobay
Ciprobay Ciprobay Ciprobay Ciprobay Uro Ciprobay Ciprobay Ciprobay
100 mg 250 mg 500 mg 750 mg
100 mg/ 50 ml 200 mg/ 100 ml 400 mg/ 200 ml 100 mg 250 mg 500 mg 750 mg
film-coated tablets film-coated tablets film-coated tablets film-coated tablets
raztopina za infundiranje raztopina za infundiranje raztopina za infundiranje filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete
oral use oral use oral use oral use
intravenska uporaba intravenska uporaba intravenska uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
100 mg 250 mg 500 mg 750 mg
2 mg/ ml 2 mg/ ml 2 mg/ ml 100 mg 250 mg 500 mg 750 mg
Bayer HealthCare AG D-51368 Leverkusen
Bayer HealthCare AG D- 51368 Leverkusen Nemčija
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
250 mg 500 mg 750 mg 200 mg/ 100 ml 400 mg/ 200 ml 50 mg/ ml 100 mg/ ml
film-coated tablets solution for infusion solution for infusion oral suspension oral suspension
filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete raztopina za infundiranje raztopina za infundiranje peroralna suspenzija peroralna suspenzija
oral use intravenous use intravenous use oral use oral use
peroralna uporaba peroralna uporaba peroralna uporaba intravenska uporaba intravenska uporaba peroralna uporaba peroralna uporaba
750 mg 2 mg/ ml 2 mg/ ml 50 mg/ ml 100 mg/ ml
250 mg 500 mg 750 mg 2 mg/ ml 2 mg/ ml 50 mg/ ml 100 mg/ ml
200 mg/ 100 ml 400 mg/ 200 ml
250 mg 500 mg 200 mg/ 100 ml 400 mg/ 200 ml
solution for infusion solution for infusion
filmsko obložene tablete filmsko obložene tablete raztopina za infundiranje raztopina za infundiranje
intravenous use intravenous use
peroralna uporaba peroralna uporaba intravenska uporaba intravenska uporaba
2 mg/ ml 2 mg/ ml
250 mg 500 mg 2 mg/ ml 2 mg/ ml
Bayer HealthCare AG Ciproxin 51368 Leverkusen, Ciproxin Germany Ciproxin Ciproxin Ciproxin
Bayer HealthCare AG 51368 Leverkusen, Nemčija Bayer Santé
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion
filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete raztopina za infundiranje raztopina za infundiranje
oral use oral use oral use intravenous use intravenous use
peroralna uporaba peroralna uporaba peroralna uporaba intravenska uporaba intravenska uporaba
Bayer Santé Ciflox 13, rue Jean Jaurès Ciflox 92807 Puteaux Cedex Uniflox France
13, rue Jean Jaurès 92807 Puteaux Cedex Francija
film-coated tablets film-coated tablets film-coated tablets
filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete
oral use oral use oral use
peroralna uporaba peroralna uporaba peroralna uporaba
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 400 mg/ 200 ml
film-coated tablets oral suspension oral suspension solution for infusion solution for infusion
peroralna suspenzija peroralna suspenzija raztopina za infundiranje raztopina za infundiranje
oral use oral use oral use intravenous use intravenous use
peroralna uporaba peroralna uporaba intravenska uporaba intravenska uporaba
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
raztopina za infundiranje raztopina za infundiranje raztopina za infundiranje filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete peroralna suspenzija peroralna suspenzija
intravenous use intravenous use intravenous use oral use oral use oral use oral use oral use oral use oral use
intravenska uporaba intravenska uporaba intravenska uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
15125 Marousi, Athens, CIPROXIN Greece
15125 Marousi, Athens, Grčija
CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN
CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN CIPROXIN XR
400 mg/ 200 ml 500 mg 750 mg 250 mg/ 5 ml 500 mg/ 5 ml
200 mg/ 100 ml 400 mg/ 200 ml 500 mg 750 mg 250 mg/ 5 ml 500 mg/ 5 ml 500 mg
solution for infusion film-coated tablets film-coated tablets oral suspension oral suspension
raztopina za infundiranje raztopina za infundiranje filmsko obložene tablete filmsko obložene tablete peroralna suspenzija peroralna suspenzija tablete s prirejenim sproščanjem
intravenous use oral use oral use oral use oral use
intravenska uporaba intravenska uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
2 mg / ml 500 mg 750 mg 50 mg/ ml 100 mg/ ml
2 mg/ ml 2 mg / ml 500 mg 750 mg 50 mg/ ml 100 mg / ml 500 mg
modified release tablets
tablete s prirejenim sproščanjem
film-coated tablets film-coated tablets solution for infusion
filmsko obložene tablete filmsko obložene tablete raztopina za infundiranje
oral use oral use intravenous use
peroralna uporaba peroralna uporaba intravenska uporaba
solution for infusion solution for infusion
raztopina za infundiranje raztopina za infundiranje
intravenous use intravenous use
intravenska uporaba intravenska uporaba
Bayer Healthcare AG Ciproxin 51368 Leverkusen, Ciproxin Germany Ciproxin Ciproxin Ciproxin
Bayer Healthcare AG 51368 Leverkusen, Nemčija
film-coated tablets film-coated tablets
filmsko obložene tablete filmsko obložene tablete
oral use use oral use use
peroralna uporaba use peroralna uporaba use
Dublin 18, Ireland Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
Dublin 18, Irska
film-coated tablets film-coated tablets oral suspension oral suspension solution for infusion solution for infusion solution for infusion
filmsko obložene tablete filmsko obložene tablete peroralna suspenzija peroralna suspenzija raztopina za infundiranje raztopina za infundiranje raztopina za infundiranje
oral use use oral use use oral use use oral use use intravenous use intravenous use intravenous use
peroralna uporaba use peroralna uporaba use peroralna uporaba use peroralna uporaba use intravenska uporaba intravenska uporaba intravenska uporaba
Bayer HealthCare AG CIFLOX D-51368 Leverkusen, CIFLOX Germany
Bayer HealthCare AG D- 51368 Leverkusen, Nemčija
oral use
CIPROXIN
6 Member State
tablete s prirejenim sproščanjem
Marketing Authorisation Invented name Holder
peroralna uporaba
Strength
CIPROXIN
Pharmaceutical Form
tablete s prirejenim sproščanjem