FrancophonIA/ELRC3.0 huggingface dataset:
English: CABOMETYX Placebo these therapies had to discontinue study treatment.
Slovenian: Bolniki, ki so bili deležni teh oblik zdravljenja, so morali zdravljenje v študiji prekiniti.
English: Method of administration CABOMETYX is for oral use.
Slovenian: Zdravilo CABOMETYX se jemlje peroralno.
English: CABOMETYX 20 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.
Slovenian: CABOMETYX 20 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje kabozantinib (S)-malat, kar ustreza 20 mg kabozantiniba.
English: CABOMETYX 60 mg film-coated tablets
Slovenian: CABOMETYX 60 mg filmsko obložene tablete
English: In the treatment-naïve RCC study (CABOSUN), the incidence of severe haemorrhagic events (Grade ≥ 3) was 5.1% (4/78) in cabozantinib-treated RCC patients.
Slovenian: V študiji, izvedeni pri predhodno nezdravljenih bolnikih s KLC (CABOSUN), je pojavnost dogodkov hude krvavitve (≥ 3. stopnje) pri bolnikih s KLC, ki so se zdravili s kabozantinibom, znašala 5,1 %
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets cabozantinib NAME OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma EXPIRY DATE
Slovenian: IME ZDRAVILA CABOMETYX 20 mg filmsko obložene tablete kabozantinib IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Ipsen Pharma DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: What you need to know before you take CABOMETYX Do not take CABOMETYX
Slovenian: Kaj je zdravilo CABOMETYX in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo CABOMETYX Kako jemati zdravilo CABOMETYX Možni neželeni učinki
English: What CABOMETYX is
Slovenian: Kaj je zdravilo CABOMETYX
English: • Shortness of breath
Slovenian: • vnetje trebušne slinavke
English: CABOMETYX 40 mg film-coated tablets
Slovenian: CABOMETYX 40 mg filmsko obložene tablete
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER NAME OF THE MEDICINAL PRODUCT CABOMETYX 60 mg film-coated tablets cabozantinib NAME OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma EXPIRY DATE
Slovenian: IME ZDRAVILA CABOMETYX 60 mg filmsko obložene tablete kabozantinib IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Ipsen Pharma DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER NAME OF THE MEDICINAL PRODUCT CABOMETYX 40 mg film-coated tablets cabozantinib NAME OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma EXPIRY DATE
Slovenian: IME ZDRAVILA CABOMETYX 40 mg filmsko obložene tablete kabozantinib IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Ipsen Pharma DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Ear and labyrinth disorders tinnitus
Slovenian: Ušesne bolezni, vključno z motnjami labirinta tinitus
English: PFS and ORR findings are summarized in Table 6.
Slovenian: Povzetek rezultatov za preživetje brez napredovanja bolezni (PFS) in delež objektivnega odziva (ORR) je prikazan v preglednici 6.
English: The tablets are yellow oval shaped with no score, and debossed with “XL” on one side and “60” on the other side of the tablet.
Slovenian: Tablete so rumene, ovalne brez razdelilne zareze, z vtisom "XL" na eni strani in "60" na drugi strani tablete.
English: The tablets are yellow triangle shaped with no score, and debossed with “XL” on one side and “40” on the other side of the tablet.
Slovenian: Tablete so rumene, trikotne brez razdelilne zareze, z vtisom "XL" na eni strani in "40" na drugi strani tablete.
English: NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets cabozantinib STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Slovenian: IME ZDRAVILA CABOMETYX 20 mg filmsko obložene tablete kabozantinib NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje kabozantinib (S)-malat, kar ustreza 20 mg kabozantiniba.
English: CABOMETYX 60 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 60 mg of cabozantinib.
Slovenian: CABOMETYX 60 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje kabozantinib (S)-malat, kar ustreza 60 mg kabozantiniba.
English: In the HCC study (CELESTIAL), hepatic encephalopathy was reported more frequently in the cabozantinib than the placebo arm. Cabozantinib has been associated with diarrhoea, vomiting, decreased appetite and electrolyte abnormalities.
Slovenian: V študiji HCK (CELESTIAL) so o jetrni encefalopatiji poročali pogosteje v skupini s kabozantinibom kot v skupini s placebom.
English: Fatal perforations have occurred in the cabozantinib clinical program.
Slovenian: V kliničnem programu kabozantiniba so se pojavile perforacije, ki so se končale s smrtjo bolnika.
English: (see section 2 for lactose content) - Film coating: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172) What CABOMETYX looks like and contents of the pack CABOMETYX 20 mg film-coated tablets are yellow, round with no score, and identified with “XL” on one side and “20” on the other side.
Slovenian: Izgled zdravila CABOMETYX in vsebina pakiranja Zdravilo CABOMETYX 20 mg filmsko obložene tablete so rumene, okrogle, brez razdelilne zareze, identificirane z "XL" na eni strani in "20" na drugi strani tablete.
English: Progression-free survival (PFS) by Investigator Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0042
Slovenian: Preživetje brez napredovanja bolezni (PFS) po oceni raziskovalca Mediana PFS v mesecih (95-% IZ) HR (95-% IZ); stratificiranib,c
English: CABOMETYX 40 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.
Slovenian: CABOMETYX 40 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje kabozantinib (S)-malat, kar ustreza 40 mg kabozantiniba.
English: A population PK analysis did not identify clinically relevant differences in PK of cabozantinib based on race.
Slovenian: Podatki, na podlagi katerih bi bilo mogoče ugotoviti razlike v farmakokinetiki na podlagi rase, niso na voljo.
English: Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Slovenian: Pri bolnikih s KLC in HCK je priporočeni odmerek zdravila CABOMETYX 60 mg enkrat na dan. Zdravljenje je treba nadaljevati tako dolgo, dokler bolnik več nima kliničnih koristi od terapije ali do pojava nesprejemljive toksičnosti.
English: • Wound complications
Slovenian: • zapleti z ranami
English: • Increase in level of potassium in the blood
Slovenian: • zvišanje ravni kalija v krvi
English: • Swelling, pain in your hands and feet, or shortness of breath.
Slovenian: • oteklina, bolečina dlani ali stopal ali kratka sapa
English: ORR (partial responses only) Stable disease
Slovenian: ORR (le delni odzivi)
English: Progression-free survival (PFS) by IRC a Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0005
Slovenian: Preživetje brez napredovanja bolezni (PFS) po oceni IRC a Mediana PFS v mesecih (95-% IZ) HR (95-% IZ); stratificiranib,c
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT CABOMETYX 40 mg film-coated tablets cabozantinib STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.
Slovenian: IME ZDRAVILA CABOMETYX 40 mg filmsko obložene tablete kabozantinib NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje kabozantinib (S)-malat, kar ustreza 40 mg kabozantiniba.
English: Severe haemorrhage, sometimes fatal, has been observed with cabozantinib.
Slovenian: Pri uporabi kabozantiniba so opazili hude krvavitve, ki so bile včasih tudi usodne.
English: Fatal haemorrhages have occurred in the cabozantinib clinical program.
Slovenian: V kliničnem programu kabozantiniba so se pojavile krvavitve, ki so se končale s smrtjo bolnika.
English: Each film-coated tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib.
Slovenian: Zdravilo CABOMETYX 60 mg filmsko obložene tablete vsebuje kabozantinib (S)-malat, ki ustreza 60 mg kabozantiniba.
English: Avoid becoming pregnant while being treated with CABOMETYX.
Slovenian: Med uporabo zdravila CABOMETYX ne smete zanositi.
English: Each film-coated tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib.
Slovenian: Zdravilo CABOMETYX 40 mg filmsko obložene tablete vsebuje kabozantinib (S)-malat, ki ustreza 40 mg kabozantiniba.
English: • Bone damage in the jaw
Slovenian: • okvara čeljustne kosti
English: Therefore, the recommendations made here can only be used as a starting point for individual dose setting.
Slovenian: Zato se tukaj navedena priporočila uporablja le kot izhodišče za določitev posameznega odmerka.
English: {Name and address} <{Tel}> <{Fax}> <{E-mail}>
Slovenian: {Ime in naslov} <{tel}> <{faks}> <{e-pošta}>
English: The main areas of disharmony in the existing product information relate to:
Slovenian: Glavna področja razhajanja v obstoječih informacijah o zdravilu se nanašajo na:
English: Bayer BV Energieweg 1
Slovenian: Nizozemska Bayer BV Energieweg 1
English: aureus, together with a bacteriological cure of 66.67%.
Slovenian: aureus, bakteriološko ozdravitev pa pri 66,67 %.
English: Reptiles are ectothermic, relying on external heat sources to maintain their body temperature at the optimum level for correct function of all body systems.
Slovenian: Plazilci so ektotermični , odvisni od zunanjih virov toplote , da ohranijo svojo telesno temperaturo na optimalni ravni, za pravilno delovanje vseh telesnih sistemov.
English: These signs are generally mild and transient.
Slovenian: Ti znaki so navadno blagi in prehodni.
English: Do not eat, drink or smoke whilst handling the product.
Slovenian: Med dajanjem pripravka, ne jejte, pijte ali kadite.
English: Siemensova 2717/4 155 00 Praha 5
Slovenian: Siemensova 2717/4 155 00 Praha 5 Češka
English: Litvínovská 609/3 190 21 Praha 9
Slovenian: Litvínovská 609/3 190 21 Praha 9 Češka
English: Because the safety and the efficiency of the product have not been assessed in cats less than 8 weeks, the contraindication in such animals is justified.
Slovenian: Ker varnosti in učinkovitosti zdravila niso ocenili pri mačkah, mlajših od 8 tednov, je kontraindikacija pri teh živalih upravičena.
English: Bayer Hungária Kft. Alkotás u. 50
Slovenian: Madžarska Bayer Hungária Kft. Alkotás u. 50
English: No residue depletion data were made available.
Slovenian: Podatki o izločanju ostankov niso na voljo.
English: Do not use in cats less than 8 weeks of age.
Slovenian: Ne uporabite pri mačkah, mlajših od 8 tednov starosti.
English: Therefore, the veterinarian must be aware of the correct temperature requirements of the respective reptile species and the hydration status of the individual patient.
Slovenian: Zato mora veterinar poznati ustrezne temperaturne zahteve določenih vrst plazilcev in status hidracije posameznega pacienta.
English: If necessary, depending on the severity of clinical signs, this dosage can be doubled.
Slovenian: Po potrebi, dovisno od teže kliničnih znakov odmerek lahko podvojimo.
English: Do not use in growing horses because of possible deleterious damage on articular cartilage.
Slovenian: Ne uporabite pri rastočih konjih, zaradi možnih poškodb sklepnega hrustanca.
English: Do not use concurrently with theophylline as the elimination of theophylline may be delayed.
Slovenian: Ne uporabljajte sočasno s teofilini, ker se izločanje teofilina lahko upočasni.
English: The overall benefit-risk balance of the products was deemed positive subject to the recommended changes in the product information (see Annex III).
Slovenian: Celotno razmerje med tveganji in koristmi za zdravila je bilo ocenjeno kot ugodno pod pogojem, da se upoštevajo priporočene spremembe v informacijah o zdravilu (glejte Prilogo III).
English: Wash any splashes from skin or eyes immediately with water.
Slovenian: Pri stiku pripravka s kožo ali očmi, kožo in oči nemudoma sperite z vodo.
English: In countries where feeding of fallen stock to scavenger bird populations is permitted as a conservation measure (see Commission Decision 2003/322/EC), the possible risk to hatching success should be considered before feeding carcasses of livestock recently treated with this product.
Slovenian: V državah, kjer je krmljenje poginulih živali pticam mrhovinarkam dovoljeno kot ukrep za ohranjanje vrst (glej Sklep Komisije 2003/322/ES), je treba upoštevati možno tveganje za valjenje, pred hranjenjem s kadavri živine, ki je bila pred kratkim zdravljena s tem zdravilom.
English: The success rate was 76% on day 3 and 50% on day 10 in the test group versus 14.3% and 9.5%, respectively, for the same days, for the reference product.
Slovenian: Delež uspešnosti v preiskovani skupini je bil 76-odstoten na 3. dan in 50odstoten na 10. dan v primerjavi s 14,3- oziroma 9,5-odstotnim deležem na ista dneva pri referenčnem zdravilu.
English: An extension of the treatment interval to 48 hours may be necessary in individual cases.
Slovenian: Včasih je pri posameznih primerih potrebno podaljšanje intervala zdravljenja do 48 ur.
English: In very rare cases intravenous treatment of cattle can cause shock reactions, presumably as a result of circulatory impairment.
Slovenian: V redkih primerih lahko intravenozno zdravljenje goveda povzroči šok reakcije, domnevno kot posledica oslabitve obtočil.
English: During this referral and considering the scope of the procedure, adequate data have been submitted to support the following posology (depending on the indications):
Slovenian: Glede na obseg postopka je bilo med tem napotitvenim postopkom predloženih dovolj podatkov, ki so podprli naslednje odmerjanje (odvisno od indikacij):
English: In dogs, a moderate and transient local reaction (such as oedema) may occur.
Slovenian: Pri psih se lahko pojavijo zmerne in prehodne lokalne reakcije (kot je oteklina).
English: In accidental overdose there is no antidote and treatment should be symptomatic.
Slovenian: V primeru nenamerne aplikacije prevelikega odmerjanja ni antidota, zdravljenje pa mora biti simptomatsko.
English: However, the provided results do not allow assessing the efficacy of the products for each one of these agents individually because only data about M. haemolytica have been provided.
Slovenian: Vendar pa predloženi rezultati niso omogočili ocene učinkovitosti zdravil za posamezne povzročitelje, saj so bili predloženi samo podatki za M. haemolytica.
English: The local tolerance was followed during tolerance and/or clinical studies in pigs, calves and dogs.
Slovenian: Lokalno toleranco so proučevali v študijah tolerance in/ali kliničnih študijah na prašičih, teletih in psih.
English: Detrimental effects on developing eggs of avian scavengers were reported when these birds ingest livestock meat from animals previously administered with fluoroquinolone.
Slovenian: Poročali so o škodljivih učinkih na razvijajoča se jajca ptičev mrhovinarjev, kadar te ptice zaužijejo meso živine, ki je predhodno prejemala fluorokinolon.
English: The presence of the renal portal system in reptiles means it is prudent to administer substances in the front half of the body wherever possible.
Slovenian: Prisotnost portalnega sistema ledvic plazilcev zahteva dajanje snovi v prvo polovico telesa, kjer je to mogoče .
English: Although horses are not authorised as target species the Committee considered that a contraindication for use in growing horses should be included in the product information for the 50 mg/ml and 100 mg/ml strengths.
Slovenian: Čeprav konji niso odobrena ciljna živalska vrsta, je odbor menil, da mora biti kontraindikacija za uporabo pri odraščajočih konjih vključena v informacije o zdravilu, in sicer za jakosti 50 mg/ml in 100 mg/ml.
English: In case of complicated infections higher doses may be necessary.
Slovenian: V primeru zapletenih okužb so lahko potrebni večji odmerki.
English: Metabolism of substances and activity of the immune system are, thus, critically dependent on the body temperature.
Slovenian: Presnova snovi in aktivnosti imunskega sistema so močno odvisni od telesne temperature .
English: Mild and transient digestive tract disorders are common with many antibiotics, including fluoroquinolones.
Slovenian: Blage in prehodne prebavne motnje so pogoste pri mnogih antibiotikih, vključno s fluorokinoloni.
English: Then in countries where feeding of fallen stock to scavenger bird populations is permitted as a conservation measure special warnings have to be keep in order to reduce the risk for these birds.
Slovenian: V državah, kjer je hranjenje populacij ptičev mrhovinarjev s poginulo živino dovoljeno kot ohranitveni ukrep, je treba uvesti in vzdrževati posebna opozorila, da se zmanjša tveganje za te ptice.
English: Concerning target species cattle and pigs a risk has been identified regarding an insufficient dose rate against target pathogens in cattle and pigs.
Slovenian: Pri ciljnih živalskih vrstah, govedu in prašičih, so ugotovili tveganje glede nezadostnega odmerjanja proti ciljnim patogenom pri govedu in prašičih.
English: Overall drug concentrations peak at 2 hours after treatment showing an approximately 3-fold higher total exposure over the 24 hours dosing interval compared to plasma.
Slovenian: 2 urah po zdravljenju, kar kaže na približno 3-krat večjo skupno izpostavljenost v 24 urah intervalnega odmerjanja v primerjavi s plazmo.
English: In complicated infections, higher dosages and longer treatment courses may be necessary.
Slovenian: Pri zapletenih okužbah so lahko potrebni višji odmerki in daljše zdravljenje.
English: Care should be taken to avoid accidental self-injection.
Slovenian: Previdnost je potrebna, da ne pride do nenamernega samo-injiciranja.
English: The section on interactions takes into account for all relevant interactions between enrofloxacin and other substances.
Slovenian: Poglavje o medsebojnem delovanju vključuje vse pomembne interakcije med enrofloksacinom in drugimi učinkovinami.
English: Do not use in young dogs during their growth, i.e. in small breeds of dogs less than 8 months of age, in big breeds of dogs less than 12 months of age, in giant breeds of dogs less than 18 months of age.
Slovenian: Ne uporabite pri mladih rastočih psih, to je pri malih pasmah psov do 8. meseca starosti, pri velikih pasmah psov do 12. meseca starosti, pri zelo velikih pasmah psov pa do 18. meseca starosti.
English: If accidental self-injection occurs seek medical advice immediately.
Slovenian: V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom.
English: The mode of action of enrofloxacin is bactericidal and bactericidal activity is concentration dependent.
Slovenian: Mehanizem delovanja enrofloksacina je baktericiden in baktericidna akivnost je odvisna od koncentracije.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, imetnikov dovoljenj za promet v državah članicah
English: Further to the assessment of the available data withdrawal periods were established and several contraindications and warning sentences are recommended to ensure the safe use of the products.
Slovenian: Poleg ocene razpoložljivih podatkov so določili karence in priporočili več kontraindikacij ter opozorilnih stavkov, s katerimi se bo zagotovila varna uporaba teh zdravil.
English: The data provided consist of studies performed with several posology regimens where the more frequent dose of 5 mg/kg bw was used.
Slovenian: Predloženi podatki vključujejo študije, opravljene z več režimi odmerjanja, v katerih so najpogosteje uporabili odmerek 5 mg/kg telesne mase.
English: Furthermore, it has to be considered that large differences exist in the pharmacokinetic behaviour of enrofloxacin among different species, which additionally will influence the decision about the correct dosage of “product name (to be completed nationally)”.
Slovenian: Poleg tega je treba upoštevati, da obstajajo velike razlike v farmakokinetiki enrofloksacina pri različnih vrstah, kar bo še dodatno vplivalo na odločitev o pravilnem odmerjanju <Izmišljeno ime> 25 mg/ml ( izpolni država članica ) " .
English: Accumulation in plasma does not occur following a treatment interval of 24 h.
Slovenian: Do kopičenja v plazmi ne pride pri intervalu zdravljenja na 24 ur.
English: Taking into account all the documentation provided, the CVMP considered that this indication can be accepted, but in the 50 mg/ml strength it should be stated as “Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis”.
Slovenian: Upoštevajoč vso predloženo dokumentacijo je odbor CVMP menil, da je ta indikacija sprejemljiva, vendar je treba pri jakosti 50 mg/ml navesti »Zdravljenje akutnega, z mikoplazmo povezanega artritisa, ki ga povzročajo za enrofloksacin občutljivi sevi Mycoplasma bovis«.
English: Therefore in order to optimise the dosage and to avoid development of resistance it has been concluded, that the dose rate of 2.5 mg/kg bw/day should be deleted for all the indications in cattle.
Slovenian: Za optimizacijo odmerka in preprečevanje razvoja odpornosti so zato sklenili, da je treba odmerjanje 2,5 mg/kg telesne mase/dan izbrisati iz vseh indikacij pri govedu.
English: In pigs, no adverse effects were reported after the administration of 5 times the recommended dose.
Slovenian: Pri prašičih niso poročali o nobenih neželenih učinkih po uporabi 5-kratnega priporočenega odmerka.
English: The overall evaluation of the submitted data (clinical, PK/PD and resistance data) show that the dose of 2.5 mg/kg bw/day may not allow for a complete elimination of bacteria and it could lead to an increased resistance development.
Slovenian: Splošna ocena predloženih podatkov (kliničnih, FK/FD in podatkov o odpornosti) kaže, da odmerek 2,5 mg/kg telesne mase/dan morda ne bo zadosten za popolno odstranitev bakterij in lahko povzroči razvoj povečane odpornosti.
English: 50 ml and 100 ml in a cardboard box.
Slovenian: 50 ml in 100 ml steklenice v kartonasti škatli.
English: Because of known effects of quinolones on articular joints in growing dogs, the contraindication in such animals is justified.
Slovenian: Zaradi znanih učinkov kinolonov na sklepe pri odraščajočih psih je kontraindikacija pri teh živalih upravičena.
English: Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects but have shown evidence of foetotoxic effects at maternotoxic doses.
Slovenian: Z laboratorijskimi študijami na podganah in kuncih niso bili dokazani teratogeni učinki, bili pa so dokazani fetotoksični učinki, pri odmerkih toksičnih za mater.
English: In calves, transient local tissue reactions may occur in very rare cases and may be observed up to 14 days.
Slovenian: Pri govedu se lahko v zlo redkih primerih pojavijo prehodne lokalne reakcije tkiva ki so lahko vidne do 14 dni.
English: On 26 October 2012, France sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names.
Slovenian: Dne 26. oktobra 2012 je Francija poslala obvestilo o napotitvi v skladu s členom 34(1) Direktive 2001/82/ES, kakor je bila nazadnje spremenjena, odboru CVMP/Evropski agenciji za zdravila za zdravila Baytril 2,5 % raztopina za injiciranje, Baytril 5 % raztopina za injiciranje ter Baytril 10 % raztopina za injiciranje in povezana imena.
English: Parent substance and active metabolite are cleared from the body via urine and faeces.
Slovenian: Izvorno zdravilo in aktivni presnovek se izločita iz telesa prek urina in blata.
English: Local reactions at injection site
Slovenian: Lokalne reakcije na mestu vboda
English: Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols).
Slovenian: Ne uporabljajte enrofloksacina sočasno z antimikrobnimi snovmi, ki delujejo antagonistično na kinolone (npr. makrolidi, tetraciklini, fenikoli).