natgillin/translations-raw huggingface dataset:
Aranesp 500 micrograms solution for injection in pre-filled pen 1 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. 
Aranesp 500 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 ml raztopine za injiciranje (500 µg/ml darbepoetina alfa) v napolnjenem injekcijskem peresniku z injekcijsko brizgo iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
NAME OF THE MEDICINAL PRODUCT Aranesp 80 micrograms solution for injection in pre-filled syringe Darbepoetin alfa 
Aranesp 80 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi darbepoetin alfa
Cardiac disorders 
• možganska kap
EU/1/01/185/003 1 pack EU/1/01/185/004 4 pack EU/1/01/185/076 1 pack with needle guard EU/1/01/185/077 4 pack with needle guard 
EU/1/01/185/076 pakiranje po 1 s ščitnikom igle EU/1/01/185/077 pakiranje po 4 s ščitnikom igle
NAME OF THE MEDICINAL PRODUCT Aranesp 30 micrograms solution for injection in pre-filled syringe Darbepoetin alfa 
Aranesp 30 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi darbepoetin alfa
Aranesp 40 micrograms solution for injection in pre-filled pen 0.4 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. 
Aranesp 40 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,4 ml raztopine za injiciranje (100 µg/ml darbepoetina alfa) v napolnjenem injekcijskem peresniku z injekcijsko brizgo iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/055 1 pack 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/185/055 - pakiranje po 1
NAME OF THE MEDICINAL PRODUCT Aranesp 100 micrograms solution for injection in pre-filled syringe Darbepoetin alfa 
Aranesp 100 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi darbepoetin alfa
Aranesp 30 micrograms solution for injection in pre-filled pen 0.3 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. 
Aranesp 30 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,3 ml raztopine za injiciranje (100 µg/ml darbepoetina alfa) v napolnjenem injekcijskem peresniku z injekcijsko brizgo iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
NAME OF THE MEDICINAL PRODUCT Aranesp 50 micrograms solution for injection in pre-filled syringe Darbepoetin alfa 
Aranesp 50 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi darbepoetin alfa
Aranesp 60 micrograms solution for injection in pre-filled pen 0.3 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. 
Aranesp 60 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,3 ml raztopine za injiciranje (200 µg/ml darbepoetina alfa) v napolnjenem injekcijskem peresniku z injekcijsko brizgo iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
NAME OF THE MEDICINAL PRODUCT Aranesp 15 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 15 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
EU/1/01/185/018 4 Pack Blister 
EU/1/01/185/018 pakiranje po 4
Aranesp 130 micrograms solution for injection in pre-filled pen 0.65 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. 
Aranesp 130 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,65 ml raztopine za injiciranje (200 µg/ml darbepoetina alfa) v napolnjenem injekcijskem peresniku z injekcijsko brizgo iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
Aranesp 60 micrograms solution for injection in pre-filled syringe 0.3 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. 
Aranesp 60 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi 0,3 ml raztopine za injiciranje (200 µg/ml darbepoetina alfa) v napolnjeni injekcijski brizgi iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled pen contains 20 micrograms darbepoetin alfa (40 micrograms/mL). 
NAVEDBA ENE ALI VEČ UČINKOVIN En 0,5-ml napolnjen injekcijski peresnik vsebuje 20 mikrogramov darbepoetina alfa (40 mikrogramov/ml).
EU/1/01/185/009 1 pack EU/1/01/185/010 4 pack EU/1/01/185/082 1 pack with needle guard EU/1/01/185/083 4 pack with needle guard 
EU/1/01/185/082 pakiranje po 1 s ščitnikom igle EU/1/01/185/083 pakiranje po 4 s ščitnikom igle
Aranesp 10 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 1.52 mg of sodium in 0.4 mL. 
Aranesp 10 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjeni injekcijski peresnik vsebuje 1,52 mg natrija v 0,4 ml.
NAME OF THE MEDICINAL PRODUCT Aranesp 50 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 50 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
• Keep used syringes out of the reach and sight of children. 
• Uporabljene injekcijske brizge shranjujte nedosegljive otrokom.
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/053 1 pack 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/185/053 - pakiranje po 1
Aranesp 100 micrograms solution for injection in pre-filled pen 0.5 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. 
Aranesp 100 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,5 ml raztopine za injiciranje (200 µg/ml darbepoetina alfa) v napolnjenem injekcijskem peresniku z injekcijsko brizgo iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
Aranesp 300 micrograms solution for injection in pre-filled pen 0.6 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. 
Aranesp 300 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,6 ml raztopine za injiciranje (500 µg/ml darbepoetina alfa) v napolnjenem injekcijskem peresniku z injekcijsko brizgo iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
EU/1/01/185/069 1 pack EU/1/01/185/070 4 pack EU/1/01/185/092 1 pack with needle guard EU/1/01/185/093 4 pack with needle guard 
EU/1/01/185/092 pakiranje po 1 s ščitnikom igle EU/1/01/185/093 pakiranje po 4 s ščitnikom igle
EU/1/01/185/019 1 pack EU/1/01/185/020 4 pack EU/1/01/185/094 1 pack with needle guard EU/1/01/185/095 4 pack with needle guard 
EU/1/01/185/094 pakiranje po 1 s ščitnikom igle EU/1/01/185/095 pakiranje po 4 s ščitnikom igle
EU/1/01/185/039 1 Pack Unblistered EU/1/01/185/086 1 blister pack with needle guard EU/1/01/185/087 4 blister pack with needle guard Aranesp 80 micrograms solution for injection pre-filled syringe EU/1/01/185/015 1 Pack Blister 
EU/1/01/185/086 pakiranje po 1 s ščitnikom igle EU/1/01/185/087 pakiranje po 4 s ščitnikom igle
Aranesp 130 micrograms solution for injection in pre-filled syringe 0.65 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. 
Aranesp 130 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi 0,65 ml raztopine za injiciranje (200 µg/ml darbepoetina alfa) v napolnjeni injekcijski brizgi iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
EU/1/01/185/044 1 Pack Unblistered EU/1/01/185/098 1 blister pack with needle guard EU/1/01/185/099 4 blister pack with needle guard Aranesp 10 micrograms solution for injection pre-filled pen EU/1/01/185/045 - 1 pack 
EU/1/01/185/098 pakiranje po 1 s ščitnikom igle EU/1/01/185/099 pakiranje po 4 s ščitnikom igle
Finger grips Syringe label Syringe barrel 
Nalepka brizge Valj brizge
EU/1/01/185/001 1 pack EU/1/01/185/002 4 pack EU/1/01/185/074 1 pack with needle guard EU/1/01/185/075 4 pack with needle guard 
EU/1/01/185/074 pakiranje po 1 s ščitnikom igle EU/1/01/185/075 pakiranje po 4 s ščitnikom igle
EU/1/01/185/070 4 Pack Blister 
EU/1/01/185/070 pakiranje po 4
Aranesp 10 micrograms solution for injection in pre-filled syringe 0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. 
Aranesp 10 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi 0,4 ml raztopine za injiciranje (25 µg/ml darbepoetina alfa) v napolnjeni injekcijski brizgi iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
NAME OF THE MEDICINAL PRODUCT Aranesp 30 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 30 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
AMQ e Rash/erythema adverse reaction includes PT rash, rash pruritic, rash macular, rash generalised, erythema. 
e Neželeni učinek izpuščaj/eritem vključuje naslednje PT: izpuščaj, pruritični izpuščaj, makularni izpuščaj,
NAME OF THE MEDICINAL PRODUCT Aranesp 10 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 10 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
EU/1/01/185/021 1 pack EU/1/01/185/022 4 pack EU/1/01/185/096 1 pack with needle guard EU/1/01/185/097 4 pack with needle guard 
EU/1/01/185/096 pakiranje po 1 s ščitnikom igle EU/1/01/185/097 pakiranje po 4 s ščitnikom igle
Aranesp 30 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL. 
Aranesp 30 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjeni injekcijski peresnik vsebuje 1,14 mg natrija v 0,3 ml.
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/100 1 pack 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/185/100 - pakiranje po 1
NAME OF THE MEDICINAL PRODUCT Aranesp 20 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 20 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/050 1 pack 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/185/050 - pakiranje po 1
EU/1/01/185/011 1 pack EU/1/01/185/012 4 pack EU/1/01/185/084 1 pack with needle guard EU/1/01/185/085 4 pack with needle guard 
EU/1/01/185/084 pakiranje po 1 s ščitnikom igle EU/1/01/185/085 pakiranje po 4 s ščitnikom igle
NAME OF THE MEDICINAL PRODUCT Aranesp 80 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 80 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
NAME OF THE MEDICINAL PRODUCT Aranesp 100 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 100 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
NAME OF THE MEDICINAL PRODUCT Aranesp 300 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 300 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
NAME OF THE MEDICINAL PRODUCT Aranesp 60 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 60 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
NAME OF THE MEDICINAL PRODUCT Aranesp 40 micrograms solution for injection in pre-filled pen Darbepoetin alfa 
Aranesp 40 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
Aranesp 60 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL. 
Aranesp 60 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjeni injekcijski peresnik vsebuje 1,14 mg natrija v 0,3 ml.
EU/1/01/185/015 1 pack EU/1/01/185/016 4 pack EU/1/01/185/088 1 pack with needle guard EU/1/01/185/089 4 pack with needle guard 
EU/1/01/185/088 pakiranje po 1 s ščitnikom igle EU/1/01/185/089 pakiranje po 4 s ščitnikom igle
EU/1/01/185/041 1 Pack Unblistered EU/1/01/185/090 1 blister pack with needle guard EU/1/01/185/091 4 blister pack with needle guard Aranesp 130 micrograms solution for injection pre-filled syringe EU/1/01/185/069 1 Pack Blister 
EU/1/01/185/090 pakiranje po 1 s ščitnikom igle EU/1/01/185/091 pakiranje po 4 s ščitnikom igle
EU/1/01/185/017 1 pack EU/1/01/185/018 4 pack EU/1/01/185/090 1 pack with needle guard EU/1/01/185/091 4 pack with needle guard 
EU/1/01/185/080 pakiranje po 1 s ščitnikom igle EU/1/01/185/081 pakiranje po 4 s ščitnikom igle
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/051 1 pack 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/185/051 - pakiranje po 1
0.6 ml (10 mg/ml) 
0,6 ml (10 mg/ml) 1 napolnjena injekcijska brizga
Subcutaneous use pre-filled syringe (glass) 
6 mg raztopina za injiciranje subkutana uporaba napolnjena injekcijska brizga (steklena)
Strength Pharmaceutical Form 
Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
London, 16 August 2007 Doc. 
London, 16. avgust 2007 Sklic dok.
Ref. EMEA/374268/2007 
EMEA/374268/2007
This may help to treat some types of bacterial infections. 
To utegne pripomoči k zdravljenju določenih vrst bakterijskih okužb.
The design of some of these studies, which were carried out a few years ago, was not aligned with the latest recommendations for the study of new antibiotics. 
Zasnova nekaterih od teh študij, ki so bile izvedene pred nekaj letih, ni bila skladna z najnovejšimi priporočili za preučevanje novih antibiotikov.
The application was at day 180 when the company withdrew. 
Vloga je bila v postopku 180. dan, ko jo je podjetje umaknilo.
The letter from the company notifying the EMEA of the withdrawal of the application is available here. 
Dopis podjetja, v katerem so EMEA obvestili o umiku vloge, je na voljo tukaj.
International non-proprietary name (INN): garenoxacin mesylate 
Mednarodno nelastniško ime (INN): garenoksacin
In all studies, the main measure of effectiveness was the proportion of patients whose infection had been cured, at least five days after the end of treatment, although time at which the effectiveness was assessed depended on the type of infection being treated. 
Pri vseh študijah je bilo glavno merilo učinkovitosti delež bolnikov, pri katerih je bila okužba ozdravljena, in sicer vsaj pet dni po koncu zdravljenja, čeprav je bil čas, ob katerem so ocenjevali učinkovitost, odvisen od vrste zdravljene okužbe.
In almost all studies, it was compared with other antibiotics (clarithromycin, co-amoxiclav, amoxicillin, levofloxacin, ceftriaxone, erythromycin, azithromycin, piptazobactam or metronidazole). 
Pri skoraj vseh študijah so zdravilo primerjali z drugimi antibiotiki (klaritromicinom, koamoksiklavom, amoksicilinom, levofloksacinom, ceftriaksonom, eritromicinom, azitromicinom, piptazobaktamom ali metronidazolom).
The CHMP was concerned that there was not enough evidence to demonstrate the medicine's effectiveness in treating some of the infections that it was expected to be used for. 
CHMP je bil zaskrbljen, da ni dovolj dokazov, ki bi potrjevali učinkovitost zdravila pri zdravljenju nekaterih okužb, za katere bi se naj zdravilo uporabljalo.
It was also unclear whether the medicine had an effect on the control of glucose (sugar) levels in the body. 
Prav tako ni bilo jasno ali zdravilo vpliva na uravnavanje krvnega sladkorja (glukoze v krvi) v telesu.
Prior to this withdrawal, the company had already withdrawn its application for some indications, as well as for the solution for infusion. 
Pred tem umikom je podjetje že umaknilo svojo vlogo za nekatere indikacije, kakor tudi vlogo za raztopino za infundiranje.
Furthermore, the CHMP had concerns over the side effects of Garenoxacin mesylate, particularly a risk of low blood pressure. 
Poleg tega je imel CHMP pomisleke v zvezi z neželenimi stranskimi učinki zdravila Garenoksacin mesilat , še posebej v zvezi s tveganjem za nizek krvni tlak.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding. 
Potem ko je CHMP ocenil odgovore podjetja na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
It works by blocking the action of enzymes that are necessary for the bacteria to make DNA. 
Deluje tako, da blokira delovanje encimov, ki je potrebno, da bi bakterije lahko tvorile DNK.
On 25 July 2007, Schering-Plough Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Garenoxacin mesylate 400 mg and 600 mg film-coated tablets and 2 mg/ml solution for infusion, for the treatment of bacterial infections. 
Podjetje Schering-Plough Europe je dne 25. julija 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za izdajo dovoljenja za promet z zdravilom Garenoksacin mesilat, v obliki 400 in 600 mg filmsko obloženih tablet in 2 mg/ml raztopine za infundiranje, namenjenim za zdravljenje bakterijskih okužb.
By blocking these enzymes, garenoxacin mesylate prevents certain types of bacteria from growing and multiplying. 
Z blokiranjem teh encimov garenoksacin mesilat prepreči rast in razmnoževanje določenih vrst bakterij.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Garenoxacin mesylate could not have been approved for the treatment of bacterial infections. 
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge določene zadržke in bil začasnega mnenja, da zdravila Garenoksacin mesilat ni mogoče odobriti za zdravljenje bakterijskih okužb.
What are the consequences of the withdrawal for patients undergoing clinical trials with Garenoxacin mesylate? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih zdravila Garenoksacin mesilat?
Garenoxacin mesylate was examined in 19 studies involving a total of over 7,000 patients with the types of bacterial infection that the medicine was expected to be used to treat. 
Zdravilo Garenoksacin mesilat so preučevali v 19 študijah, v katerih je sodelovalo skupaj več kot 7000 bolnikov z vrstami bakterijskih okužb, za zdravljenje katerih bi se naj zdravilo uporabljalo.
The effects of Garenoxacin mesylate were first tested in experimental models before being studied in humans. 
Učinki zdravila Garenoksacin mesilat so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Garenoxacin mesylate is a medicine that was to be available as tablets (400 mg and 600 mg) and as a solution for infusion (drip into a vein). 
Garenoksacin mesilat je zdravilo, ki bi naj bilo na voljo v obliki tablet (400 mg in 600 mg) in raztopine za infundiranje (dajanje v veno).
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for GARENOXACIN MESYLATE 
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA IZDAJO DOVOLJENJA ZA PROMET za zdravilo GARENOKSACIN MESILAT
• complicated intra-abdominal infections, including infections after surgery and acute infections of the pelvis. 
• zapletenimi intraabdominalnimi okužbami, vključno z okužbami po kirurških posegih in akutnimi okužbami v medenici.
Garenoxacin mesylate was expected to be used to treat adults with the following infections: 
Zdravilo Garenoksacin mesilat bi se naj uporabljalo za zdravljenje odraslih z naslednjimi okužbami:
Garenoxacin mesylate is an antibiotic that belongs to the ‘quinolone' class. 
Zdravilo Garenoksacin mesilat je antibiotik, ki sodi v razred kinolonov.
The company informed the CHMP that no further patients are being enrolled into clinical trials with Garenoxacin mesylate, and that there are no consequences for patients already included in these trials. 
Podjetje je CHMP obvestilo, da v klinična preizkušanja zdravila Garenoksacin mesilat ne vključujejo več novih bolnikov, ter da za bolnike, ki že sodelujejo v kliničnih preizkušanjih, ni nikakršnih posledic.
• acute bacterial sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the nose and eyes), 
• akutnim bakterijskim sinusitisom (kratkotrajno okužbo sinusov, z zrakom napolnjenih votlin v kosteh okrog nosu in oči)
• acute bacterial exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the lungs), 
• akutnim bakterijskim poslabšanjem kroničnega bronhitisa (dolgotrajnega vnetja dihalnih poti v pljučih),
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Garenoxacin mesylate had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
Zato je bil v času umika CHMP mnenja, da koristi zdravila Garenoksacin mesilat niso zadostno dokazane in da niso večje od znanih tveganj.
Garenoxacin mesylate was only to be used when these infections were known to be caused by bacteria that are susceptible to the medicine. 
Zdravilo Garenoksacin mesilat bi se naj uporabljalo samo v primerih, ko bi bilo znano, da so vzrok teh okužb bakterije, občutljive na to zdravilo.
• community-acquired pneumonia (an infection of the lungs that is caught outside of hospital), 
• zunajbolnišnično pljučnico (okužbo pljuč, nastalo izven bolnišnice),
• infections of the skin and the tissue just below the skin, including foot infections in patients with diabetes, 
• okužbami kože in podkožnega tkiva, vključno z okužbo stopal pri sladkornih bolnikih,
What is Garenoxacin mesylate? 
Kaj je zdravilo Garenoksacin mesilat?
How is Garenoxacin mesylate expected to work? 
Kako naj bi zdravilo Garenoksacin mesilat delovalo?
What was Garenoxacin mesylate expected to be used for? 
Za kaj naj bi se zdravilo Garenoksacin mesilat uporabljalo?
The potential risk for humans is unknown. 
Potencialno tveganje za človeka ni znano.
After that carry on as normal. 
Po tem nadaljujte jemanje kot običajno.
In individual cases, only some of these symptoms and/or findings may be evident. 
V posameznih primerih so lahko prisotni le nekateri od teh simptomov in/ali izsledkov preiskav.
- You should take only one tablet each time. 
- Vsakič vzemite samo eno tableto.
Date of first authorisation: 24 August 2011 Date of latest renewal: 26 May 2016 
Datum prve odobritve: 24. avgust 2011 Datum zadnjega podaljšanja: 26. maj 2016
Consult your doctor if you think this applies to you. 
Posvetujte se z vašim zdravnikom, če menite, da velja to tudi za vas.
This may cause difficulties in breathing or swallowing. 
To lahko povzroči težave z dihanjem ali požiranjem.
To open the bottle for the first time: open the closure, and then press with your thumb on the seal until it breaks. 
Da prvič odprete steklenico: odprite zamašek in nato pritisnite s palcem navzdol na pregrado dokler se ne zlomi.
Otherwise, you may put yourself and others at risk of serious injury or death. 
Če tega ne upoštevate, lahko izpostavite sebe in druge tveganju resne poškodbe ali smrti.
Accordingly, to date there has been no indication of such interactions. 
Glede na to do sedaj niso bile ugotovljene tovrstne interakcije.
Therefore, be particularly careful when you drive or when you use any tools or machines. 
Zato bodite še posebej pazljivi, če vozite ali uporabljate kakršna koli orodja ali stroje.
Dose reduction may be needed (see section 5.2). 
Lahko da bo potrebno zmanjšati odmerek (glejte poglavje 5.2).
After taking one of them, wait at least 2 to 3 hours before taking the other. 
Ko vzamete eno od obojega, počakajte najmanj 2 do 3 ure preden vzamete drugo zdravilo.
The INR values increased on average by 13% [CI90 6-19%]. 
Vrednosti INR so se povečale v povprečju za 13 % [CI90 6-19 %].
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. 
- Glede na to, kako se odzivate na zdravljenje, bo vaš zdravnik lahko predlagal večji ali manjši odmerek.