FrancophonIA/ELRC3.0 huggingface dataset:
English: No dosage adjustment is required in patients with mild renal impairment (estimated CrCL ≥ 51≤ 80 mL/min) (see section 5.2).
Slovenian: Bolnikom z blago okvaro ledvic (ocenjeni očistek kreatinina od 51 do ≤ 80 ml/min) odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Additional antibacterial agents should be used when these pathogens are known or suspected to be contributing to the infectious process.
Slovenian: Če je znano, ali obstaja sum, da so v infekcijsko dogajanje vpleteni ti patogeni, je treba uporabiti dodatna protibakterijska zdravila.
English: Dosing of Zavicefta on haemodialysis days should occur after completion of haemodialysis.
Slovenian: Na dan hemodialize je treba zdravilo Zavicefta uporabiti po dokončani hemodializi.
English: 0.75 g/0.1875 g Every 12 hours
Slovenian: 0,75 g/0,1875 g na 12 ur
English: The mean elimination half-life of ceftazidime ranged from 3.5 to 4 hours following intravenous bolus dosing with 2 g every 12 hours in elderly patients aged 80 years or older.
Slovenian: Po uporabi intravenskih bolusnih odmerkov 2 g ceftazidima na 12 ur pri bolnikih, starih 80 let ali več, je bil njegov povprečni eliminacijski razpolovni čas od 3,5 do 4 ure.
English: No appreciable accumulation of ceftazidime or avibactam was observed following multiple intravenous infusions of 2000 mg/500 mg of ceftazidime/avibactam administered every 8 hours for up to 11 days in healthy adults with normal renal function.
Slovenian: Pri zdravih odraslih z normalnim delovanjem ledvic niso zabeležili opaznega kopičenja ceftazidima ali avibaktama po večkratnih intravenskih infuzijah 2000 mg ceftazidima/500 mg avibaktama na 8 ur do 11 dni.
English: • increase in the number of a type of blood cell (called “lymphocytes”) - shown in blood tests
Slovenian: • povečanje števila določene vrste krvnih celic (imenovanih "limfociti") - pokaže se na preiskavah krvi
English: Clostridium difficile-associated diarrhoea has been reported with ceftazidime/avibactam, and can range in severity from mild to life-threatening.
Slovenian: Med zdravljenjem s ceftazidimom/avibaktamom je bila opisana driska zaradi Clostridium difficile, ki je lahko blaga do smrtno nevarna.
English: 0.75 g/0.1875 g Every 48 hours
Slovenian: 0,75 g/0,1875 g na 48 ur
English: Common (≥1/100 and <1/10) Uncommon (≥1/1,000 and <1/100) Rare (≥1/10,000 and <1/1000) Very rare (<1/10,000)
Slovenian: Občasni (≥ 1/1.000 in < 1/100)
English: Table 2 Recommended intravenous doses for patients with estimated CrCL ≤ 50 mL/min Estimated CrCL (mL/min)
Slovenian: Priporočeni intravenski odmerek za bolnike z ocenjenim očistkom kreatinina ≤ 50 ml/min Ocenjeni očistek kreatinina (ml/min)
English: A total of 81 cUTI patients (7.4%) had bacteraemia at baseline.
Slovenian: Bakteriemijo je izhodiščno imelo81 bolnikov (7,4 %) z zapleteno okužbo sečil.
English: Hospital-acquired pneumonia including ventilator-associated pneumonia Gram-negative micro-organisms
Slovenian: Bolnišnična pljučnica, vključno s pljučnico zaradi uporabe respiratorja Gramnegativni mikroorganizmi
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: If you get any side effects, talk to your doctor or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
English: Uncommon: (may affect up to 1 in 100 people)
Slovenian: Občasni: (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: In-vitro data indicate that the following species are not susceptible to ceftazidime/avibactam.
Slovenian: Podatki in vitro kažejo, da za kombinacijo ceftazidim/avibaktam niso občutljive naslednje vrste:
English: 0.75 g/0.1875 g Every 24 hours
Slovenian: 0,75 g/0,1875 g na 24 ur
English: What Zavicefta looks like and contents of the pack Zavicefta is a white to yellow powder for concentrate for solution for infusion in a vial.
Slovenian: Zdravilo Zavicefta je bel do rumen prašek za koncentrat za raztopino za infundiranje v viali.
English: Complicated urinary-tract infections Gram-negative micro-organisms
Slovenian: Zapletene okužbe sečil Gramnegativni mikroorganizmi
English: Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion
Slovenian: Zavicefta 2 g/0,5 g prašek za koncentrat za raztopino za infundiranje
English: • tingling or numbness
Slovenian: • mravljinčenje ali omrtvičenost
English: The steady-state volumes of distribution of ceftazidime and avibactam were about 22 L and 18 L, respectively in healthy adults following multiple doses of 2000 mg/500 mg ceftazidime/avibactam infused over 2 hours every 8 hours.
Slovenian: Pri zdravih odraslih, ki so prejeli večkratne odmerke 2000 mg ceftazidima/500 mg avibaktama, infundirane v 2 urah vsakih 8 ur, sta bila njuna volumna porazdelitve v stanju dinamičnega ravnovesja približno 22 l (ceftazidim) in 18 l (avibaktam).
English: Neurological sequelae, including tremor, myoclonus, non-convulsive status epilepticus, convulsion, encephalopathy and coma, have occasionally been reported with ceftazidime when the dose has not been reduced in patients with renal impairment.
Slovenian: Če bolnikom z okvaro ledvic niso zmanjšali odmerka ceftazidima, so med njegovo uporabo občasno poročali o nevroloških posledicah, med drugim o tremorju, mioklonusu, nekonvulzivnem epileptičnem statusu, konvulzijah, encefalopatiji in komi.
English: What Zavicefta contains
Slovenian: Kaj vsebuje zdravilo Zavicefta
English: • raised itchy skin rash (“hives”)
Slovenian: • dvignjen in srbeč izpuščaj na koži (“koprivnica”)
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja makulopapulozen izpuščaj urtikarija srbenje toksična epidermalna nekroliza
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproduction toxicity or genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Table 1 Recommended intravenous dose for patients with estimated CrCL ≥ 51 mL/min Type of infection
Slovenian: Priporočeni intravenski odmerek za bolnike z ocenjenim očistkom kreatinina ≥ 51 ml/min
English: Common: (may affect up to 1 in 10 people)
Slovenian: Pogosti: (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: What Zavicefta is
Slovenian: Kaj je zdravilo Zavicefta
English: Dose regimen
Slovenian: - Navodilo shranite.
English: • itchiness
Slovenian: • omotica
English: It is unknown whether avibactam is excreted in human milk.
Slovenian: Ceftazidim se v majhni količini izloča v materino mleko, za avibaktam pa ni znano, ali se izloča v materino mleko.
English: Zavicefta contains sodium
Slovenian: Zdravilo Zavicefta vsebuje natrij
English: 2 g/0.5 g
Slovenian: 2 g/0,5 g na 8 ur
English: oC.
Slovenian: B.
English: Dilute before use
Slovenian: Pred uporabo razredčite.
English: • stomach pain
Slovenian: • bolečine v trebuhu
English: Haemolytic anaemia
Slovenian: Bolezni imunskega sistema anafilaktična reakcija
English: 1 g/0.25 g
Slovenian: 1 g/0,25 g na 8 ur
English: Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, nemudoma obvestite zdravnika.
English: ITALY
Slovenian: ITALIJA
English: How to store Zavicefta
Slovenian: Shranjevanje zdravila Zavicefta
English: Dosage strength ceftazidime/avibactam (mg)
Slovenian: Velikost odmerka ceftazidim/avibaktam (mg)
English: To be used in combination with metronidazole when anaerobic pathogens are known or suspected to be contributing to the infectious process To be used in combination with an antibacterial agent active against Gram-positive pathogens when these are known or suspected to be contributing to the infectious process The total duration shown may include intravenous Zavicefta followed by appropriate oral therapy There is very limited experience with the use of Zavicefta for more than 14 days
Slovenian: Če je znano, ali obstaja sum, da so v infekcijsko dogajanje vpleteni anaerobni patogeni, je treba to zdravilo uporabiti v kombinaciji z metronidazolom.
English: ZAVICEFTA 2 g/0.5g powder for concentrate for solution for infusion ceftazidime/avibactam
Slovenian: Zavicefta 2 g/0,5 g prašek za koncentrat za raztopino za infundiranje ceftazidim/avibaktam
English: ZAVICEFTA 2 g/0.5 g powder for concentrate ceftazidime/avibactam
Slovenian: ZAVICEFTA 2 g/0,5 g prašek za koncentrat ceftazidim/avibaktam i.v.
English: Talk to your doctor or nurse before using Zavicefta if:
Slovenian: Pred začetkom uporabe zdravila Zavicefta se posvetujte z zdravnikom ali medicinsko sestro:
English: Susceptibility testing breakpoints
Slovenian: Mejne vrednosti za testiranje občutljivosti
English: Nervous system disorders
Slovenian: Bolezni živčevja glavobol omotica parestezije
English: Ceftazidime/avibactam use may cause development of a positive direct antiglobulin test (DAGT, or Coombs test), which may interfere with the cross-matching of blood and/or may cause drug induced immune haemolytic anaemia (see section 4.8).
Slovenian: Kombinacija ceftazidim/avibaktam lahko povzroči pozitiven izvid direktnega antiglobulinskega testa (DAGT ali Coombsovega testa).
English: Tell your doctor that you are taking Zavicefta if you are going to have any tests.
Slovenian: Če boste morali opraviti kakšne preiskave, morate zdravniku povedati, da dobivate zdravilo Zavicefta.
English: Controlled sodium diet
Slovenian: Prehrana z omejitvijo natrija
English: Urticaria
Slovenian: Dojenje
English: Ceftazidime concentrations of 4 to 20 mg/L or more are achieved in the CSF when the meninges are inflamed.
Slovenian: Če so meninge vnete, ceftazidim v cerebrospinalni tekočini doseže koncentracijo od 4 do 20 mg/l ali več.
English: • diarrhoea
Slovenian: • driska
English: Talk to your pharmacist or doctor if you have been advised to have a low salt diet.
Slovenian: Če so vam svetovali prehrano z nizko vsebnostjo soli, se posvetujte s farmacevtom ali zdravnikom.
English: Toxic epidermal necrolysis
Slovenian: Nefrotoksičnost
English: ESRD including on haemodialysis
Slovenian: Končna odpoved ledvic, vključno s hemodializo3
English: Dizziness
Slovenian: Občutljivi
English: Paraesthesia
Slovenian: Odmerjanje
English: The following indications have been justified:
Slovenian: Potrjene so bile naslednje indikacije:
English: Consequently, the same conclusions on efficacy and safety apply to both products.
Slovenian: Posledično za obe zdravili veljajo enaki zaključki o učinkovitosti in varnosti.
English: Decentralised procedure subject to an Article 33 Referral (CD 17 April 2008)
Slovenian: Decentralizirani postopek na podlagi napotitve v skladu s členom 33 (CD 17. april 2008)
English: Do not use in piglets of less than 4 weeks of age.
Slovenian: Ne uporabljajte pri pujskih, starih manj kot štiri tedne.
English: Pharmaceutical form
Slovenian: Farmacevtska oblika
English: Animal species
Slovenian: Živalske vrste
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: DODATEK III SPREMEMBE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Strength / Active substance (INN)
Slovenian: Jakost / Zdravilna učinkovina (INN)
English: The Netherlands (REG NL 10411)
Slovenian: Nizozemska (REG NL 10411)
English: Member State / Marketing Authorisation Number
Slovenian: Država članica / Številka dovoljenja za promet
English: Dopharma also described the history of the product since 1987, the year of its first authorisation in the Netherlands.
Slovenian: Družba Dopharma je opisala tudi zgodovino zdravila od leta 1987, v katerem je bilo zdravilo prvič odobreno na Nizozemskem.
English: Sodium salicylate
Slovenian: Natrijev salicilat
English: Oral explanations were provided on 15 July 2008 and the CVMP Opinion was adopted on 16 July 2008.
Slovenian: Ustna pojasnila so bila podana dne 15. julija 2008, Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pa je mnenje sprejel dne 16. julija 2008.
English: As the procedure concerns a range of products, the assessment has been limited to specific parts of the authorisations in accordance with Article 35(2) of Directive 2001/82/EC, as amended.
Slovenian: Ker napotitveni postopek zajema širok niz zdravil, je bilo ocenjevanje omejeno le na določene dele dovoljenj za promet v skladu s členom 35(2) Direktive 2001/82/ES, kot je bila spremenjena.
English: The Netherlands (REG NL 8913)
Slovenian: Nizozemska (REG NL 8913)
English: Calves and Pigs
Slovenian: Teleta in prašiči
English: 2.1 Questions put to the Marketing Authorisation Holder
Slovenian: 2.1 Vprašanja za imetnike dovoljenj za promet
English: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder and Applicant the CVMP concludes that:
Slovenian: Upoštevajoč razloge za napotitev in odgovore, ki so jih predložili imetniki dovoljenj za promet ter predlagatelj, je CVMP sklenil:
English: The Commission Decision on the Article 33 referral was adopted on 17 April 2008.
Slovenian: Komisija je sklep v zvezi z napotitvijo na podlagi člena 33 sprejela dne 17. aprila 2008.
English: On 27 November 2007, Ireland presented to the EMEA a referral under Article 35 of Directive 2001/82/EC, as amended, concerning all oral soluble powders containing sodium salicylate which are indicated for calves and pigs.
Slovenian: Irska je dne 27. novembra 2007 pri Evropski agenciji za zdravila (EMEA) sprožila napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES, kot je bila spremenjena, glede vseh praškov za peroralne raztopine, ki vsebujejo natrijev salicilat in so indicirani za zdravljenje telet in prašičev.
English: Solacyl was the subject of an Article 33 Referral, further to the submission of a Decentralised Application.
Slovenian: Zdravilo Solacyl je bilo predmet napotitve na osnovi člena 33 po predložitvi vloge za decentralizirani postopek.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER / APPLICANT
Slovenian: DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, POTI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET / PREDLAGATELJ
English: Product invented name
Slovenian: Izmišljeno ime zdravila
English: Ireland believed that the use of such a medicine for mass medication could mask the clinical signs of a developing infectious disease which could spread to other animals and thereby pose both an animal health and public health risk.
Slovenian: Irska je menila, da lahko uporaba takšnega zdravila za masovno zdravljenje zakrije klinične znake razvijajočih se okužb, ki bi se lahko prenesle tudi na druge živali, ter tako predstavlja tveganje za zdravje tako živali kot tudi ljudi.
English: • The benefit/risk balance of the product was shown to be positive, however in young animals, the summary of Product Characteristics should state that the product is not to be used in neonates or very young calves of less than 2 weeks of age nor in piglets of less than 4 weeks of age
Slovenian: • Razmerje med koristmi in tveganji se je pokazalo kot pozitivno, kljub temu pa je v povzetku glavnih značilnosti zdravila za uporabo pri mladih živalih potrebno navesti, da zdravilo ni namenjeno uporabi pri komaj skotenih ali zelo mladih teletih, starih manj kot dva tedna, ter pri pujskih, starih manj kot štiri tedne.
English: The aim of the assessment was to establish whether marketing authorisations and applications included in the referral procedure should be granted, maintained, suspended, varied or revoked with view to the grounds for referral.
Slovenian: Postopek ocenjevanja je potekal z namenom ugotoviti, ali naj se, upoštevajoč razloge za napotitev, dovoljenja za promet in vloge za pridobitev dovoljenja za promet, vključene v napotitveni postopek, odobrijo, ohranijo, umaknejo, spremenijo ali prekličejo.
English: Eurovet referred to the originator product from Dopharma, Na-salicylaat 100%, REG NL 8913.
Slovenian: Družba Eurovet se je oprla na originatorsko zdravilo družbe Dopharma, Na-salicylaat 100%, REG NL 8913.
English: Pivotal documents, including the SPC, should be presented in English.
Slovenian: Ključni dokumenti, vključno s povzetkom glavnih značilnosti zdravila, morajo biti predloženi v angleškem jeziku.
English: Amendments to be included in the relevant sections of the SPC: Asprimax 850 mg/g
Slovenian: Spremembe, ki se vključijo v ustrezna poglavja povzetka glavnih značilnosti zdravila: Asprimax 850 mg/g
English: The MAHs should discuss the benefit/risk balance of the product, with special regard to:
Slovenian: Imetniki dovoljenj za promet naj izvedejo razpravo o razmerju med koristmi in tveganji zdravila s posebnim poudarkom na:
English: Chevita Ges m.b.H.
Slovenian: Družba Chevita Ges m.b.H.
English: The referral procedure started on 11 December 2007 and after adoption of a list of questions, the clock was stopped on 15 January 2008.
Slovenian: Napotitveni postopek se je pričel dne 11. decembra 2007 in ob sprejemu seznama vprašanj je bilo odštevanje do izteka postopka začasno ustavljeno dne 15. januarja 2008.
English: Conclusion
Slovenian: Zaključek
English: submitted all requested parts of the dossier (Part I and Part IV) as well as a dose determination study, which was not included in Part IV of the application dossier.
Slovenian: je predložila vse zahtevane module dosjeja (modul I in modul IV) kot tudi študijo o določitvi odmerka, ki ni bila vključena v modul IV predloženega dosjeja.
English: It is known that sodium salicylate when administered by the intravenous route to calves prior to castration failed to attenuate the cortisol response1.
Slovenian: Znano je, da intravenozna uporaba natrijevega salicilata pri teletih, ki še niso bila kastrirana, ni oslabila sproščanja kortizola1.
English: The clock was stopped again on 14 May 2008 and restarted on 6 June when responses to the outstanding issues where received.
Slovenian: Do ponovne ustavitve odštevanja je prišlo dne 14. maja 2008, z odštevanjem pa se je nadaljevalo dne 6. junija, ko so prispeli tudi odgovori na do takrat odprta vprašanja.
English: • Therapeutic concentrations are established and maintained following oral use of sodium salicylate in calves and pigs.
Slovenian: • Terapevtske koncentracije so določene in se vzdržujejo pri peroralni uporabi natrijevega salicilata pri teletih in prašičih.
English: The MAHs are requested to provide from the dossier submitted for each country of the EEA where the products are authorised: a) the Part I Summary of the dossier including SPCs, expert reports and the full composition of the products; b) if applicable, Part IV of the application dossier; c) an Assessment of the Periodic Safety Update Reports (PSURs) in relation to target animal safety and possible lack of efficacy.
Slovenian: Imetniki dovoljenj za promet so bili pozvani, naj iz dosjeja, predloženega v vsaki državi EGP, v kateri so zadevna zdravila odobrena, predložijo naslednjo dokumentacijo: a) modul I: povzetek dosjeja, vključno s povzetkom glavnih značilnosti zdravila, poročili izvedencev in celotno sestavo zdravil; b) če je potrebno, modul IV dosjeja, predloženega za pridobitev dovoljenja za promet; c) oceno periodičnih poročil o varnosti zdravila (PSUR) v zvezi z varnostjo ciljne skupine živali in morebitnim pomanjkanjem učinkovitosti.
English: • the use for analgesic and antipyretic effects under field condition, bearing in mind that the use in young animals which are suffering disease stress may lead to a potentiation of the undesirable effects of salicylate toxicity.
Slovenian: • smislu uporabe zdravila za dosego analgetičnih in antipiretičnih učinkov v terenskih pogojih, upoštevajoč, da uporaba zdravila pri mladih živalih, pri katerih se pojavlja stres zaradi bolezni, lahko vodi k povečanju neželenih učinkov toksičnosti salicilata.
English: Do not use sodium salicylates in neonates or calves less than 2 weeks of age.
Slovenian: Ne uporabljajte natrijevega salicilata pri komaj skotenih mladičih ali teletih, starih manj kot dva tedna.
English: Ireland considered that there was a potentially serious risk to animal health by providing for the authorisation of a potentially ineffective medicine for mass use by farmers, especially when there are several authorised NSAIDs available for individual animal use.
Slovenian: Irska je menila, da odobritev dovoljenja za promet za potencialno neučinkovito zdravilo, namenjeno masovni uporabi na kmetijah, lahko predstavlja resno tveganje za živali, zlasti ker je trenutno na voljo več odobrenih nesteroidnih protivnetnih zdravil, ki so namenjena za individualno uporabo pri živalih.
English: The dosage required for calves is however 40 mg/kg bodyweight.
Slovenian: Priporočeni odmerek za teleta je 40 mg na kilogram telesne mase.
English: 2.2 Documentation provided
Slovenian: 2.2 Predložena dokumentacija
English: It was recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
Slovenian: Sprejeto je bilo priporočilo, da naj za Solacyl 100 % prašek za peroralno raztopino za teleta in prašiče, veljajo priporočila napotitve Skupnosti v skladu s členom 35(2) za praške za peroralno raztopino, ki vsebujejo natrijev salicilat.
English: Marketing Authorisation Holder
Slovenian: Imetnik dovoljenja za promet
English: As a generic product only part I and not part IV of the dossier was submitted.
Slovenian: Ker gre za generično zdravilo, je bil predložen le modul I, ne pa tudi modul IV dosjeja.
English: Further to the submission of responses to questions, the clock was re-started on 14 March 2008.
Slovenian: Ob posredovanju odgovorov na zastavljena vprašanja se je odštevanje ponovno nadaljevalo 14. marca 2008.
English: • the merits of using sodium salicylate as an oral medication for mass administration in cattle and pigs when individual treatment with parenteral NSAIDs may offer more precise therapy;
Slovenian: • prednostih uporabe natrijevega salicilata kot peroralnega zdravila za masovno uporabo pri govedu in prašičih, če lahko individualno zdravljenje s parenteralnimi nesteroidnimi protivnetnimi zdravili zagotovi natančnejšo terapijo;
English: The MAHs should submit all existing data that could demonstrate the efficacy of sodium salicylate when given to calves and pigs, together with a thorough discussion of the these data.
Slovenian: Imetniki dovoljenj za promet naj predložijo vse obstoječe podatke, ki lahko potrdijo učinkovitost uporabe natrijevega salicilata pri teletih in prašičih, skupaj s temeljito obravnavo teh podatkov.
English: Introduction and background
Slovenian: Uvod in obrazložitev
English: Dopharma submitted all requested parts of the dossier (Part I, Part IV and PSURs).
Slovenian: Družba Dopharma je predložila vse zahtevane module dosjeja (modul I, modul IV in periodična poročila o varnosti zdravila).
English: The Marketing Authorisation Holders and Applicant submitted written responses and the clock was restarted on 14 March 2008.
Slovenian: Ko so imetniki dovoljenja za promet in predlagatelj predložili pisne odgovore na vprašanja, se je odštevanje do izteka postopka nadaljevalo dne 14. marca 2008.
English: • The efficacy of sodium salicylate as supportive treatment when given to calves and pigs was demonstrated in respiratory infections and the usefulness of this compound was clear for the treatment of inflammation in combination with concurrent antibiotic therapy.
Slovenian: • Učinkovitost natrijevega salicilata kot pomožnega zdravljenja za teleta in prašiče je bila dokazana pri okužbah dihal, koristnost te spojine pa se je pokazala tudi pri zdravljenju vnetij v kombinaciji s sočasno terapijo z antibiotiki.
English: Pigs: For the treatment of inflammation in combination with concurrent antibiotic therapy.
Slovenian: Prašiči: za zdravljenje vnetij v kombinaciji s sočasno terapijo z antibiotiki.