natgillin/translations-raw huggingface dataset:
Uncommon: vomiting, digestive disorders, gassiness (flatulence), loss of appetite, abdominal pain Rare: severe and continuous diarrhoea, possibly with blood and mucus, due to a severe inflammation of the large intestine (pseudo membranous colitis), fungal infection in the mouth (oral moniliasis) Very rare:
občutek siljenja na bruhanje, driska bruhanje, prebavne motnje, vetrovi (flatulenca), izguba apetita, bolečina v trebuhu huda in trajajoča driska, lahko s krvjo ali sluzjo, zaradi hudega vnetja debelega črevesa (psevdomembranski kolitis), glivična okužba v ustih (oralna kandidoza)
fungal infection in the gastrointestinal system (gastrointestinal moniliasis), pancreas inflammation (pancreatitis)
Zelo redki: glivična okužba prebavil (gastrointestinalna kandidoza), vnetje trebušne slinavke (pankreatitis)
Disorders of the liver and gall-bladder Rare: yellowing of the skin or whites of the eyes (icterus), icterus due to a condition where the bile can not flow normally from the liver (cholestatic icterus) Very rare:
porumenelost kože ali beločnic (zlatenica), zlatenica zaradi stanja, pri katerem žolč ne more normalno prehajati iz jeter (holestatski ikterus)
liver inflammation (hepatitis), destruction of liver tissue (liver cell necrosis, very rarely resulting in life-threatening liver failure)
Zelo redki: vnetje jeter (hepatitis), uničenje jetrnega tkiva (nekroza jetrnih celic, ki zelo redko povzroči življenjsko nevarno jetrno odpoved)
Disorders of the skin and connective tissue Common:
izpuščaj srbenje (pruritus), izpuščaj v obliki madežev (makolupapulozni izpuščaj), koprivnica (urtikarija)
rash
Redki:
Uncommon: itching (pruritus), spot-shaped rash (maculopapular rash), hives (urticaria) Rare: increased sensitivity to light (photosensitivity) Very rare:
povečana občutljivost na svetlobo (fotosenzitivnost)
rash with red (moist) irregular spots (erythema (exsudativum) multiforme), tender bluish red bumps in 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)
Zelo redki: izpuščaj z rdečimi (vlažnimi) nepravilnimi madeži (eksudativni multiformni edem), občutljivi modrikasto rdeči vozli (nodozni eritem), hudo stanje z visoko vročino, rdečimi madeži na koži, bolečinami v sklepih in/ ali očesno okužbo (Stevens- Johnsonov sindrom), hudo stanje s povečano telesno temperaturo in mehurji na koži/ luščenjem kože (Lyellov sindrom)
Disorders of the skeletal muscles, tendons and bones Uncommon: joint pain (arthralgia) Rare: muscular pain (myalgia), joint disorder (swollen joints) Very rare:
Redki:
inflammation of the tendons (tendinitis, in particular of the Achilles tendon), partial or total tendon ruptures (in particular of the Achilles tendon), exacerbation of the symptoms of myasthenia gravis (a particular type of muscle weakness)
Zelo redki: vnetje kit (tendinitis, predvsem Ahilove kite), delno ali popolno raztrganje kite (predvsem Ahilove kite), poslabšanje simptomov miastenije gravis (posebne vrste mišične šibkosti)
Disorders of the kidney and urinary tract Rare: acute kidney failure, abnormal kidney function, vaginal secretion due to a fungal infection (vaginal 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)
akutna odpoved ledvic, nenormalno delovanje ledvic, nožnični izloček zaradi glivične okužbe (vaginalna kandidoza), kri v urinu (hematurija), prisotnost kristalov v urinu z neudobjem pri uriniranju (kristalurija), okužba ledvic s krvjo v urinu, povečano telesno temperaturo in stransko bolečino (intersticijski nefritis)
General disorders and administration site conditions Uncommon: general sensation of weakness, fatigue (asthenia), irritation or pain at the injection site Rare: perspiration
splošni občutek šibkosti, utrujenost (astenija), draženje ali bolečina na mestu injiciranja potenje
Investigations
Občasni:
52 Uncommon: increase of the creatinine or urea level in the blood, abnormal liver function test results, bile pigment in the blood (bilirubinaemia) and increased blood level of a certain enzyme (alkaline phosphatase) Very rare: increased blood level of amylase (enzyme that breaks down starch) and lipase (enzyme that breaks down fats).
zvišana raven kreatinina ali sečnine v krvi, nenormalni izvidi preiskav delovanja jeter, pigment žolča v krvi (bilirubinemija) in zvišana koncentracija določenega encima (alkalne fosfataze)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
49 Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Do not use Ciprofloxacin Kabi after the expiry date which is stated on the packaging after “ Exp”.
Zdravila Ciprofloxacin Kabi ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake “ Exp ”.
• Do not refrigerate or freeze. • Store the infusion bag in the overpouch until it is used in order to protect from light.
Ne shranjujte v hladilniku ali zamrzujte. • Infuzijska vrečka naj ostane v zunanjem ovoju, dokler ni pripravljena za uporabo, za zagotovitev • zaščite pred svetlobo.
What Ciprofloxacin Kabi contains • The active substance is ciprofloxacin (as hydrogen sulphate).
Kaj vsebuje zdravilo Ciprofloxacin Kabi • Zdravilna učinkovina je ciprofloksacin (v obliki ciprofloksacinijevega hidrogensulfata).
Each bag of 100 ml contains 200 mg of ciprofloxacin.
Vsaka vrečka s 100 ml vsebuje 200 mg ciprofloksacina.
Each bag of 200 ml contains 400 mg of ciprofloxacin. • The other ingredients are sodium chloride, sulphuric acid, sodium hydroxide for pH adjustment, water for injections
Vsaka vrečka z 200 ml vsebuje 400 mg ciprofloksacina.
53 Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec
Fresenius Kabi Norge AS Postboks 430 N-1753 Halden Norway
Fresenius Kabi Norge AS Postboks 430 N- 1753 Halden Norveška
This medicinal product is authorised in the Member States of the EEA under following names:
50 To zdravilo je ima dovoljenje za promet v državah članicah ES pod naslednjimi imeni:
--------------------------------------------------------------------------------------------------------------------------- --
[Izpolni država članica] ----------------------------------------------------------------------------------------------- ------------------------------
Any unused solution and the bag should be adequately disposed of, in accordance with local requirements.
Neuporabljeno raztopino in vrečko zavrzite v skladu z lokalnimi predpisi.
Ciprofloxacin Kabi 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.
Zdravilo Ciprofloxacin Kabi je združljivo z izotonično raztopino natrijevega klorida, Ringerjevo raztopino, raztopino Ringerjevega laktata, 50 mg/ ml (5- odstotne) ali 100 mg/ ml (10- odstotne) raztopine glukoze in 50 mg/ ml (5- odstotne) raztopine glukoze z 2, 25 mg/ ml (0, 225- odstotne) ali 4, 5 mg/ ml (0, 45 - odstotne) raztopine natrijevega klorida.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH Država članica
Ciprofloxacin Nycomed
Ciprofloksacin Nycomed
Nycomed Pharma AS Drammernsveien 852 NO-1372 Asker Norway
Nycomed Pharma AS Drammernsveien 852 NO- 1372 Asker Norveška
Nycomed AB Tegeluddvägen 17-21 S-102 53 Stockholm Sweden
Nycomed AB Tegeluddvägen 17- 21 S- 102 53 Stockholm Švedska
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE PRODUCT INFORMATION
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA KI JIH JE PREDSTAVILA EMEA
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Ciprofloxacin Nycomed and associated names (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA Ciprofloksacin Nycomed in z njim povezanih imen (glej Dodatek I)
Ciprofloxacin is a quinolone effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Ciprofloksacin je kinolon, ki je in vitro učinkovit proti številnim po Gramu negativnim aerobnim bakterijam, kakor tudi proti nekaterim po gramu pozitivnim organizmom.
Ciprofloxacin exerts a rapid bactericidal effect by inhibiting DNA-gyrase, resulting in inhibition of DNA synthesis.
Ciprofloksacin sproži hitro baktericidno delovanje, in sicer tako, da zavira girazo DNA, kar vodi do zaviranja sinteze DNA.
There is a linear correlation between dose and plasma concentration.
Obstaja linearna korelacija med odmerkom in koncentracijo v plazmi.
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.
Zdravljenje bolnikov z zapletenimi oblikami okužbe sečil trenutno vključuje empirično zdravljenje z antibiotikom s širokim spektrom delovanja (fluorokinoloni) in morebitno nadaljnje 10 - do 14- dnevno zdravljenje na podlagi urinokulture in občutljivosti.
In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient’ s compliance and dosing be adequate.
Da bi preprečili neuspeh zdravljenja in razvoj odpornosti, sta predpogoj sodelovanje bolnika in ustrezno odmerjanje.
During the referral procedure the Applicant/ Marketing Authorisation Holder was requested to:
V okviru napotitvenega postopka je bilo od vlagatelja/ imetnika dovoljenja za promet zahtevano, da:
1. submit clinical data and discuss the risk/ benefit of the proposed dose in urinary tract infections (UTI).
predloži klinične podatke in obravnava razmerje med tveganji in koristmi predlaganega odmerka pri okužbah sečil.
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.
Vlagatelj/ imetnik dovoljenja za promet bi naj z vidika varnosti in učinkovitosti obravnaval tako odmerek 100 mg dvakrat dnevno (bi - daily ali bid) kot odmerek 200 – 400 mg bid.
In doing so the applicant/ MAH should discuss the data in relation to complicated and uncomplicated, upper and lower urinary tract infections.
Pri tem bi naj vlagatelj/ imetnik dovoljenja za promet preučil vse podatke v zvezi z zapletenimi in nezapletenimi okužbami zgornjih in spodnjih sečil.
2. submit 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.
2. predloži klinične podatke in obravnava razmerje med tveganji in koristmi predlaganega maksimalnega dnevnega odmerka za odrasle, torej ali naj bo ta 400 mg bid ali 400 mg trikrat dnevno.
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).
Vlagatelj/ imetnik dovoljenja za promet ni predložil nobenih kliničnih podatkov, ki bi se nanašali na vprašanja v zvezi s tveganji in koristmi predlaganega odmerka za okužbe sečil in maksimalnega dnevnega odmerka za odrasle, saj je ta vloga t. i. » generična « vloga (referenčni/ originatorski izdelek Ciproxin proizvajalca Bayer).
To support the recommended posology of 200-400 mg ciprofloxacin twice daily in the treatment of complicated urinary tract infections, the applicant/ MAH provided substantial scientific evidence.
V podporo predlaganemu odmerjanju 200- 400 mg ciprofloksacina dvakrat dnevno pri zdravljenju zapletenih okužb sečil je vlagatelj/ imetnik dovoljenja za promet predložil znatne znanstvene dokaze.
A large number of published studies have demonstrated the efficacy and safety of ciprofloxacin, using the intravenous dose 200-400 mg twice daily and the corresponding oral dosage 250-500 mg bid in the treatment of urinary tract infections.
Številne objavljene raziskave so dokazale učinkovitost in varnost ciprofloksacina, uporabljenega intravensko v odmerku 200- 400 mg dvakrat dnevno ter ustreznega peroralnega odmerjanja 250- 500 mg bid pri zdravljenju okužb sečil.
Further literature searches showed that only a minority of the published literature mention the use of 100 mg intravenous ciprofloxacin twice daily, e. g.
Nadaljnja preverjanja v literaturi so pokazala, da le manjši del objav omenja uporabo 100 mg odmerka ciprofloksacina intravensko dvakrat dnevno, npr.
Martindale indicates that the usual adult intravenous dose is 100 mg to 400 mg twice daily, but the dosages is not related specifically to treatment of urinary tract infections.
Martindale nakazuje, da je običajen intravenski odmerek za odrasle 100 mg do 400 mg dvakrat dnevno, vendar pa se odmerki ne nanašajo specifično na zdravljenje okužb sečil.
No clinical study using 100 mg intravenous twice daily for the treatment of complicated urinary tract infections, was identified.
Najdena ni bila nobena klinična raziskava, v kateri bi uporabljali 100 mg ciprofloksacina intravensko dvakrat dnevno pri zdravljenju zapletenih okužb sečil.
Medical practice in the treatment of UTI’ s with ciprofloxacin has changed and developed since the time of first licensing in 1987.
Medicinska praksa v zvezi z zdravljenjem okužb sečil s ciprofloksacinom se je od prve odobritve leta 1987 spreminjala in razvijala.
The recommended posology of 200-400 mg ciprofloxacin twice daily is in line with current medical practice, supported by the published literature presented from the mid 1990’ s to date.
Priporočeno odmerjanje 200- 400 mg ciprofloksacina dvakrat dnevno je v skladu s trenutno medicinsko prakso, ki jo podpirajo predstavljene strokovne objave od sredine 90 - tih let do danes.
In addition a dose-dependent clinical response of fluoroquinolones in the treatment of complicated UTI has been demonstrated in a clinical trial by Frankenschmidt et al (1).
Nadalje je bil v klinični raziskavi Frankenschmidt et al (1) izkazan od odmerka odvisen klinični odziv fluorokinolonov pri zdravljenju zapletenih okužb sečil.
According to pharmacodynamic studies, ciprofloxacin, like other fluoroquinolones, exhibits concentration dependent killing.
V skladu s farmakodinamičnimi raziskavami izkazuje ciprofloksacin, podobno kot drugi fluorokinoloni, delovanje, ki je odvisno od koncentracije.
Thus AUC over MIC is determinative for efficacy and it is therefore crucial that substantial concentrations are achieved at the site of the target pathogens.
To pomeni, da je za učinkovitost merodajnejša koncentracija AUC kot minimalna inhibitorna koncentracija (MIK), ter je posledično ključnega pomena, da se na mestu ciljnih patogenov dosežejo znatne koncentracije.
The antimicrobial activity of fluoroquinolones in urine is reduced depending on pH and various solubles, mainly cations.
Protimikrobna aktivnost fluorokinolonov v urinu se zmanjšuje v odvisnosti od pH vrednosti in različnih topnih sestavin, zlasti kationov.
In addition, in complicated UTI, biofilm formation may play an important role where susceptibility of the pathogens is several folds reduced compared with planctonic or pure culture cells.
Nadalje utegne pri zapletenih okužbah sečil
4 sufficient for the treatment of uncomplicated UTI, while for the treatment of complicated UTI due to Pseudomonas aeruginosa at least a dose of 500 mg bid of ciprofloxacin is needed (equivalent to 400 mg intravenous twice daily).
Naber et al (2) so določili ex vivo urinarne baktericidne titre (UBT) različnih fluorokinolonov in zaključili, da utegne pri visoko občutljivem sevu E. coli za zdravljenje nezapletenih okužb sečil zadoščati nizek odmerek ciprofloksacina, torej 100 mg bid, medtem ko je za zdravljenje zapletenih okužb sečil, pogojenih s Pseudomonas aeruginosa, potreben najmanj odmerek 500 mg bid ciprofloksacina (ekvivalentno 400 mg intravensko dvakrat dnevno).
It has been shown that exposure to quinolones at subinhibitory concentrations significantly increase the mutation rate in E. coli, staphylococci, pneumococci and Mycobacterium spp., as well as selecting for resistance per se (3).
Pokazano je bilo, da izpostavitev kinolonom v subinhibitornih koncentracijah bistveno poveča stopnjo mutacij E. coli, stafilokokov, pnevmokokov in Mycobacterium spp., kakor tudi sposobnost razvoja odpornosti per se (3).
The importance of using dosage regimens of fluoroquinolones leading to in vivo concentrations exceeding the mutant prevention concentrations, thus avoiding first-step mutants, is currently stressed by leading experts within the field.
Pomen uporabe režimov odmerjanja fluorokinolonov, ki vodijo do in vivo koncentracij, ki presegajo koncentracije, pri katerih prihaja do mutacij, s čimer se izognemo mutantom prve stopnje, sedaj poudarjajo vsi vodilni strokovnjaki na tem področju.
An adequate dosing, in order to achieve optimal clinical efficacy and to prevent emergence of antimicrobial resistance, is therefore crucial both for the individual patient and for the society, especially in light of the current increase of resistant uropathogens.
Ustrezno odmerjanje, s katerim dosežemo optimalno klinično učinkovitost in preprečimo razvoj antimikrobne odpornosti, je torej ključnega pomena tako za posameznega bolnika kot tudi za družbo, še posebej v luči sedanjega povečanega pojavljanja odpornih uropatogenov.
To support the proposed maximum dose of 1200 mg (400 mg three times daily) instead of 800 mg, the applicant/ MAH referred to the published literature.
V podporo predlaganemu maksimalnemu odmerku 1200 mg (400 mg trikrat dnevno) namesto 800 mg se je vlagatelj/ imetnik dovoljenja za promet skliceval na objavljeno literaturo.
No clinical studies in the treatment of complicated or life-threatening urinary tract infections with the high 1200 mg intravenous [or 1500 mg peroral] maximum dose proposed, were included or reviewed.
Vključena ali pregledana ni bila nobena klinična raziskava v zvezi z zdravljenjem zapletenih ali življenjsko nevarnih okužb sečil z velikim 1200 mg intravenskim [ali 1500 mg peroralnim] maksimalnim priporočenim odmerkom.
However the published data presented demonstrated the safety and efficacy of thus high-dose ciprofloxacin (daily dose of with or without an option to oral switch, in various serious and life threatening infections (severe pneumonia, neutropenia, acute bacterial exacerbations of chronic bronchitis, complicated, community-acquired skin and skin structure infections, infections in cancer patients and bacteraemia).
Vendar pa objavljeni podatki izkazujejo varnost in učinkovitost tako velikih odmerkov ciprofloksacina (dnevni odmerek z ali brez opcije prehoda na peroralno uporabo) pri različnih resnih in življenjsko nevarnih okužbah (huda plučnica, nevtropenija, akutno bakterijsko poslabšanje kroničnega bronhitisa, zapletene zunajbolnišnične okužbe kože in podkožja, okužbe onkoloških bolnikov in bakteriemija).
The treatment was well tolerated, the most commonly occurring adverse event were gastrointestinal disorders.
Zdravljenje so bolniki dobro prenašali, najpogostejši neželeni stranski učinek pa so bile prebavne motnje.
The frequencies of probably and/ or possibly drug-related adverse events did not differ significantly between ciprofloxacin-treated patients and the comparator groups.
Pogostost neželenih stranskih učinkov, verjetno in/ ali morebiti povezanih z zdravilom, se ni značilno pomembno razlikovala med bolniki, zdravljenimi s ciprofloksacinom, in onimi, zdravljenimi s primerjalno učinkovino.
In light of the increasing rate of quinolone resistance in urinary pathogens in Europe, an optimal dosage regimen is therefore considered important, because underdosing may lead to an impaired clinical response and pose a risk for emergence of resistant strains.
V luči naraščajoče stopnje odpornosti urinarnih patogenov na kinolone v Evropi se optimalni režim odmerjanja smatra kot pomemben, saj utegne premajhno odmerjanje privesti do okrnjenega kliničnega odziva in predstavlja tveganje za razvoj odpornih sevov.
Resistance development is beside absolute quantitative use of quinolone agents also driven by pharmacokinetic and pharmacodynamic (PK/ PD) factors.
Na razvoj odpornosti vplivajo poleg absolutne kvantitativne uporabe kinolonov tudi farmakokinetični in farmakodinamični dejavniki.
Current PK/ PD data stress the importance of adequate dosing in order to circumscribe emergence of resistance.
Aktualni farmakokinetični in farmakodinamični podatki poudarjajo pomen ustreznega odmerjanja za omejevanje razvoja odpornosti.
These recommendations are also in line with current treatment guidelines, with clinical practice in most European countries and with the recommendations of previously approved European original and generic ciprofloxacin products.
Ta priporočila so tudi v skladu s trenutnimi smernicami za zdravljenje, s klinično prakso v večini evropskih držav ter s priporočili predhodno odobrenih evropskih originatorskih in generičnih izdelkov s ciprofloksacinom.
The daily dose of 1200 mg should not however be exceeded.
Vendar pa dnevnega odmerka 1200 mg ni dopustno preseči.
References (not all submitted are listed)
Referenčna literatura (na tem mestu niso našteti vsi predloženi dokumenti)
- The body of published literature and resistance data presented provide adequate justification, both
- Obseg predložene objavljene literature in podatkov o odpornosti zagotavlja zadostno utemeljitev,
from an efficacy and safety viewpoint, for the dosing regimen of 200-400 mg ciprofloxacin twice daily for the treatment of complicated UTI.
tako z vidika učinkovitosti kot varnosti, za režim odmerjanja 200- 400 mg ciprofloksacina dvakrat dnevno pri zdravljenju zapletenih okužb sečil.
- This product being a solution intended for intravenous infusion, should be restricted to the treatment
- Uporabo tega izdelka, torej raztopine za intravensko infuzijo, je treba omejiti na zdravljenje
of complicated UTI’ s.
zapletenih okužb sečil.
- From the published data, which have demonstrated for the proposed maximum dose 400 mg
- Iz objavljenih podatkov, ki pri resnih in življenjsko nevarnih okužbah drugih organov oz. sistemov
intravenous three times daily as a maximum dose, a superior prevention of antibiotic resistance without a significant increase in adverse reactions in serious and life-threatening infections of other organ systems, there is no reason to conclude that this favourable risk/ benefit profile would differ significantly in the treatment of complicated UTIs.
za predlagani maksimalni odmerek 400 mg intravensko trikrat dnevno kot največji odmerek izkazujejo večjo učinkovitost pri preprečevanju odpornosti na antibiotike brez značilno pomembnega povečanja neželenih učinkov, ne izhajajo nikakršni razlogi, ki bi nakazovali, da bi se to ugodno razmerje med tveganji in koristmi utegnilo pri zdravljenju zapletenih okužb sečil značilno pomembno razlikovati.
The CHMP has recommended the granting of the Marketing Authorisation(s), as well as the text to be included in the Summary of Product Characteristics, Package Leaflet and Labelling.
CHMP je priporočil podelitev dovoljenj( a) za promet z zdravilom ter spremembo Povzetka glavnih značilnosti zdravila, Označevanja in Navodil za uporabo.
These are set out in Annex III for Ciprofloxacin Nycomed and associated names (see Annex I).
Le- ti so podani v Dodatku III za Ciprofloksacin Nycomed in z njim povezana imena (glej Dodatek I).
6 ANNEX III
6 DODATEK III
AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET AND LABELLING
DOPOLNILA POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
7 SUMMARY OF PRODUCT CHARACTERISTICS
7 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA