FrancophonIA/ELRC3.0 huggingface dataset:
English: In this trial, 1987 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
Slovenian: V teh študijah so 603 randomizirane bolnike zdravili s kapecitabinom v tritedenskem ciklu jemanja 1.250 mg/m2/dvakrat na dan 14 dni, čemur je sledil enotedenski premor, 604 randomizirane bolnike pa s 5-FU in levkovorinom (shema Mayo: 20 mg/m2 levkovorina intravensko, sledilo je 425 mg/m2 5-FU v obliki intravenskega bolusa vsakih 28 dni - na prvi do peti dan).
English: Sepsis, Urinary tract infection, Cellulitis, Tonsillitis, Pharyngitis, Oral candidiasis, Influenza,
Slovenian: Infekcijske in parazitske bolezni okužba z virusom herpesa, nazofaringitis, okužba spodnjih dihal sepsa, okužba sečil, celulitis, tonzilitis, faringitis, oralna kandidoza, gripa, gastroenteritis, glivična okužba, okužba, zobni absces
English: 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks); 127 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for two weeks followed by a 7-day rest period), oxaliplatin (130 mg/m2 as a 2 hour infusion on day 1 every 3 weeks),
Slovenian: V zdravljenje s kapecitabinom (1.000 mg/m2 dvakrat na dan dva tedna, čemur je sledil 7dnevni premor), oksaliplatinom (130 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne) in bevacizumabom
English: Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Slovenian: Srčne bolezni nestabilna angina pektoris, angina pektoris, miokardna ishemija, atrijska fibrilacija, aritmija, tahikardija, sinusna tahikardija, palpitacije ventrikularna fibrilacija (redki), podaljšanje intervala QT (redki), torsade de pointes (redki), bradikardija (redki), vazospazem (redki)
English: Sleep disorder, Anxiety
Slovenian: Psihiatrične motnje motnje spanja, tesnoba
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 500 mg capecitabine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
English: Furthermore, the Committee noted that alternative treatments are available.
Slovenian: Odbor je tudi ugotovil, da obstajajo alternativne oblike zdravljenja.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING LUMIRACOXIB (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO LUMIRAKOKSIB (glejte Dodatek I)
English: GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATIONS
Slovenian: PODLAGA ZA PREKLIC DOVOLJENJ ZA PROMET Z ZDRAVILI
English: However, the available evidence (based on the latest analysis of adverse reaction reports) suggests that existing monitoring requirements and other risk minimisation measures may be inadequate to sufficiently guarantee patient safety.
Slovenian: Vendar razpoložljivi dokazi (na osnovi najnovejših analiz poročil o neželenih reakcijah) kažejo, da obstoječe zahteve po spremljanju in drugih ukrepih za čim večje zmanjšanje tveganja morda niso zadostne za primerno jamstvo varnosti bolnika.
English: Although the majority of these events were reported for 200 or 400 mg, there have been reports also for the 100 mg dose, which is the dose approved in the EU.
Slovenian: Večina teh dogodkov je bila opisanih za odmerka 200 in 400 mg, vendar so bila poročila tudi za odmerek 100 mg, ki je odobren v EU.
English: Furthermore, a number of spontaneous reports of hepatic disorders associated with use of lumiracoxib (up to 15 November 2007, in total 181) have been received, including 74 reports which were judged to be related to lumiracoxib, and to be serious.
Slovenian: Poleg tega so prejeli več spontanih poročil o boleznih jeter, ki so bile povezane z uporabo lumirakoksiba (skupno 181 do 15. novembra 2007), vključno s 74 poročili, za katere so presodili, da so povezana z lumirakoksibom in da so resna.
English: However, it is unknown and questionable if these advantages would be maintained if the NSAID was co-administered with a proton pump inhibitor, or in patients concomitantly taking low dose acetylsalicylic acid.
Slovenian: Vendar je neznano in vprašljivo, ali se ta prednost ohrani, če NSPZ jemljemo sočasno z zaviralcem protonske črpalke ali če bolniki sočasno jemljejo nizek odmerek acetilsalicilne kisline.
English: The available data (clinical trial results and spontaneous reporting) suggest a dose and possibly duration dependant effect, although some cases (even at the 100 mg dose) were observed after short duration of treatment.
Slovenian: Razpoložljivi podatki (rezultati kliničnih preizkušanj in podatkov iz spontanih poročil) kažejo, da gre za učinek, odvisen od odmerka in morda trajanja, čeprav je do nekaterih primerov (tudi pri odmerku 100 mg) prišlo po kratkem obdobju zdravljenja.
English: The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing lumiracoxib at the 100 mg dose.
Slovenian: Odbor je upošteval postopek v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo lumirakoksib v odmerku 100 mg.
English: The CHMP discussed the matter at its November 2007 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je o tem razpravljal na plenarnem zasedanju novembra 2007, kjer se je začel postopek v skladu s členom 107(2) Direktive 2001/83/ES, kakor je bila spremenjena.
English: Medicinal products containing 100 mg lumiracoxib were authorised in the United Kingdom (UK) in 2003 and are authorised in a number of EU Member States via mutual recognition (see Annex I for the list of lumiracoxib containing medicinal products authorised in the EU).
Slovenian: Zdravila, ki vsebujejo 100 mg lumirakoksiba, so bila leta 2003 odobrena v Združenem kraljestvu in nato v številnih državah članicah EU po postopku medsebojnega priznavanja (glejte Dodatek I, kjer je seznam vseh v EU odobrenih zdravil, ki vsebujejo lumirakoksib).
English: Importantly, the interval between treatment periods and the frequency of liver test monitoring which would be needed to sufficiently reassure the safe use is unknown.
Slovenian: Pomembno je, da ni ugotovljen interval med obdobji zdravljenja in pogostostjo preiskav jeter, ki bi zadostno zagotovila varno uporabo zdravila.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR REVOCATION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA PREKLIC DOVOLJENJ ZA PROMET Z ZDRAVILI, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Following the provisions under Article 107 (2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) prepared an Opinion on 13 December 2007 recommending the revocation of the Marketing Authorisations for all lumiracoxib containing medicinal products in Annex I. The CHMP also recommended that temporary measures are needed in order to protect public health and therefore recommends to the European Commission that the marketing and the use of lumiracoxib containing medicinal products be suspended forthwith in all concerned EU Member States awaiting the adoption of final measures.
Slovenian: Skladno z določili iz člena 107(2) Direktive 2001/83/ES, kakor je bila spremenjena, je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji 13. decembra 2007 pripravil mnenje o priporočilu preklica vseh dovoljenj za promet z zdravili, ki vsebujejo lumirakoksib in so navedena v Dodatku I. CHMP meni tudi, da so za zaščito javnega zdravja potrebni začasni ukrepi, zato priporoča Evropski komisiji, da do uvedbe končnih ukrepov v vseh zadevnih državah članicah EU nemudoma zadrži trženje in uporabo zdravil, ki vsebujejo lumirakoksib.
English: It is not possible to reliably estimate the magnitude of the risk based on spontaneous reporting rates.
Slovenian: Na osnovi spontanega poročanja ni mogoče zanesljivo oceniti obsega tveganja.
English: It is acknowledged that lumiracoxib 100 mg once daily offers a gastrointestinal safety advantage compared with naproxen 1000 mg and ibuprofen 2400 mg.
Slovenian: Priznava se, da ima 100 mg lumirakoksiba enkrat dnevno prednost pred 1000 mg naproksena in 2400 mg ibuprofena zaradi varnosti za prebavila.
English: Furthermore, the risk for ‘off-label' use of higher doses than that approved, for longer periods than recommended raised additional concerns, due to the potential dose and duration dependent increase of the risk.
Slovenian: Poleg tega zbuja dodatne zadržke tveganje „neprimerne“ uporabe odmerkov, ki so višji od odobrenih, za dlje časa, kot je odobreno, zaradi tveganja, ki se potencialno povečuje z odmerkom in trajanjem zdravljenja.
English: Additional risk minimisation measures proposed by the marketing authorisation holder included a restriction of pack size to 2 weeks of treatment, the implementation of a treatment registry, and a long-term epidemiological cohort study.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal dodatne ukrepe za čim večje zmanjšanje tveganja, vključno z omejitvijo velikosti pakiranja, da zadostuje za 2 tedna zdravljenja, uvedbo registra zdravljenja in dolgoročno epidemiološko kohortno študijo.
English: They are available under the invented names Frexocel, Hirzia, Prexige and Stellige as film coated tablets for oral administration.
Slovenian: Ta zdravila so dostopna pod izmišljenimi imeni Frexocel, Hirzia, Prexige in Stellige v obliki filmsko obloženih tablet za peroralno uporabo.
English: Several risk minimisation measures are presently in place, including a contraindication in patients with present or previous hepatic dysfunction or being treated with other hepatotoxic medicines; and recommendations for baseline and on treatment liver test monitoring.
Slovenian: Trenutno se izvaja več ukrepov za čim večje zmanjšanje tveganja, vključno z uvedbo kontraindikacije za bolnike z obstoječo ali anamnestično disfunkcijo jeter ali za bolnike, ki se zdravijo z drugimi hepatotoksičnimi zdravili, in s priporočili za izvajanje preiskav jeter pred zdravljenjem in med zdravljenjem.
English: Lumiracoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the group of the selective cyclooxygenase-2 (COX-2) inhibitors indicated for symptomatic relief in the treatment of osteoarthritis of the knee and hip.
Slovenian: Lumirakoksib je nesteroidno protivnetno zdravilo (NSPZ) iz skupine selektivnih zaviralcev ciklooksigenaze-2 (COX-2), ki je indicirano za lajšanje simptomov pri zdravljenju osteoartritisa kolena in kolka.
English: On 9 November 2007, the United Kingdom Competent Authority (MHRA) issued a Rapid Alert informing the Member States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of the intention to suspend the Marketing Authorisations for lumiracoxib containing medicinal products in its Member State.
Slovenian: Britanski pristojni organ (MHRA) je 9. novembra 2007 izdal hitro obvestilo, s katerim je v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, obvestil države članice, agencijo EMEA in Evropsko komisijo o nameravanem zadržanju dovoljenj za promet z zdravili, ki vsebujejo lumirakoksib, v svoji državi.
English: In its assessment the MHRA concluded that lumiracoxib at the 100 mg dose was associated with an increased risk of hepatotoxicity.
Slovenian: MHRA v svojem vrednotenju meni, da je 100 mg odmerek lumirakoksiba povezan s povečanim tveganjem hepatotoksičnosti.
English: However, such short treatment duration is not compatible with the effective management of a chronic disease (osteoarthritis of the knee and hip), and taking the characteristics of the disease into account, readministration of lumiracoxib would be necessary.
Slovenian: Vendar takšno kratkotrajno zdravljenje ni združljivo z učinkovitim obvladovanjem kronične bolezni (osteoartritisa kolena in kolka), saj bi bilo treba lumirakoksib zaradi narave bolezni uporabiti ponovno.
English: Taking all these elements into account, the CHMP concluded that the benefit/risk balance for lumiracoxib is not considered favourable and recommended the revocation of the Marketing Authorisations for the medicinal products referred to in Annex I.
Slovenian: Ob upoštevanju vseh naštetih elementov CHMP meni, da za lumirakoksib razmerje med koristmi in tveganji ni ugodno, in je priporočil preklic dovoljenj za promet z zdravili, ki so navedena v Dodatku I.
English: The Committee, in light of the above findings, concluded that the benefit/risk balance of lumiracoxib containing medicinal products at the 100 mg dose is not favourable.
Slovenian: Odbor je v luči zgoraj omenjenih ugotovitev zaključil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo lumirakoksib v odmerku 100 mg, ni ugodno.
English: However, there are alternatives with a comparable gastrointestinal safety profile including other COX-2 inhibitors or NSAID given together with gastroprotection.
Slovenian: Vendar obstajajo alternativna zdravila s primerljivim profilom varnosti za prebavila, vključno z drugimi zaviralci COX-2 ali sočasnim jemanjem NSPZ in zaščite za prebavila.
English: To conclude, the present and newly proposed restrictions are not considered sufficiently reassuring to prevent the risk for adverse hepatic reactions such as the ones which have been reported spontaneously.
Slovenian: Zaključujemo, da trenutno veljavnih in na novo predlaganih omejitev ne štejemo za zadostno zagotovilo preprečitve tveganja neželenih učinkov v jetrih, kakršni so bili navedeni v spontanih poročilih.
English: The Committee concluded that there is increasing evidence for lumiracoxib-associated risk of hepatotoxicity at the 100 mg dose, and in some cases a short time to onset cannot be excluded.
Slovenian: Odbor je zaključil, da obstaja vedno več dokazov o tveganju hepatotoksičnosti odmerka 100 mg, povezanem s lumirakoksibom, in da v določenih primerih ni mogoče izključiti nastopa teh neželenih učinkov v kratkem času.
English: The proposed risk minimisation measures are neither considered to assure adequate patient safety, nor to be realistic given the approved clinical indication.
Slovenian: Predlagane ukrepe za čim večje zmanjšanje tveganja ne štejemo niti za zagotovilo primerne varnosti bolnikov niti za realistično izvedljive glede na odobreno klinično indikacijo.
English: Lumiracoxib is indicated in the treatment of osteoarthritis of the knee and hip, which is a chronic, but not life-threatening disease, where long-term treatment is usually needed.
Slovenian: Lumirakoksib je indiciran za zdravljenje osteoartritisa kolena in kolka, kronične bolezni, ki ne ogroža življenja, vendar je običajno potrebno dolgotrajno zdravljenje.
English: The Committee considered that the proposed risk minimisation measures cannot assure adequate patient safety, and are not considered realistic given the approved clinical indication.
Slovenian: Odbor je mnenja, da predlagani ukrepi za čim večje zmanjšanje tveganja ne morejo zagotoviti primerne varnosti bolnikov in da so glede na odobreno klinično indikacijo nerealistični.
English: The Committee considered that lumiracoxib is indicated for symptomatic relief in the treatment of osteoarthritis of the knee and hip and that this is a not a life-threatening condition.
Slovenian: Odbor je upošteval, da je lumirakoksib indiciran za lajšanje simptomov pri zdravljenju osteoartritisa kolena in kolka in da ta bolezen ne ogroža življenja.
English: No gastrointestinal advantage of lumiracoxib has been demonstrated against celecoxib, another COX-2 inhibitor.
Slovenian: Prednost lumirakoksiba v zvezi z varnostjo za prebavila ni bila dokazana v primerjavi s celekoksibom, ki je drug zaviralec COX-2.
English: An increased risk for serious hepatotoxic adverse drug reactions has been identified with lumiracoxib, for which an early onset cannot be excluded.
Slovenian: Pri uporabi lumirakoksiba so ugotovili povečano tveganje resnih hepatotoksičnih neželenih učinkov, pri čemer ni mogoče izključiti zgodnjega nastopa.
English: There is evidence from clinical trials that lumiracoxib is associated with a higher risk for hepatic adverse reactions compared with naproxen, ibuprofen and celecoxib.
Slovenian: V kliničnih preizkušanjih so dokazali, da je lumirakoksib v primerjavi z naproksenom, ibuprofenom in celekoksibom povezan z večjim tveganjem za neželene reakcije v jetrih.
English: (see section 4.5).
Slovenian: (glej poglavje 4.5).
English: Types and Mechanisms of Resistance
Slovenian: Vrste in obrambni mehanizmi odpornosti
English: Administer directly into the mouth.
Slovenian: Aplicirajte neposredno v gobček.
English: The period of growth depends on the breed.
Slovenian: Obdobje rasti je odvisno od pasme.
English: (see section “Special Warnings”).
Slovenian: (glej poglavje »Posebna opozorila«).
English: However in the clinical studies feeding did not reveal any impact on the treatment effect.
Slovenian: Kljub temu pa hranjenje v kliničnih raziskavah ni pokazalo nobenega vpliva na učinkovitost zdravljenja.
English: Dogs, cats
Slovenian: Psi, mačke
English: Tell your veterinarian if your animal has impaired kidney function.
Slovenian: Povejte svojemu veterinarju, če ima vaša žival okrnjeno funkcijo ledvic.
English: The bioavailability of the tablet is at least 70%.
Slovenian: Biološka razpoložljivost tablete je najmanj 70 %.
English: Veraflox oral suspension is supplied in two different presentations:
Slovenian: Veraflox peroralna suspenzija je v dveh različnih pakiranjih:
English: In case of accidental contact with the eyes, wash immediately with water.
Slovenian: V primeru nenamernega stika z očmi, oči nemudoma operite z vodo.
English: Mechanical cleaning of teeth and removal of plaque and calculus or extraction of teeth are prerequisites for a persistent therapeutic effect.
Slovenian: Mehanično čiščenje zob, odstranjevanje mehkih oblog in zobnega kamna ali puljenje so predpogoj za trajni terapevtski učinek.
English: The bacteria were isolated between 2001 and 2007 from clinical cases in Belgium, France, Germany, Hungary, Poland, Sweden and UK.
Slovenian: Bakterije so v obdobju od 2001 do 2007 izolirali iz kliničnih primerov v Belgiji, Nemčiji, Madžarski, Poljski, Švedski in Združenem kraljestvu.
English: Duration of treatment (days)
Slovenian: Trajanje zdravljenja (število dni)
English: During treatment, animals should therefore not be exposed to excessive sunlight.
Slovenian: Med zdravljenjem živali ne izpostavljajte pretirani sončni svetlobi.
English: Pradofloxacin may increase sensitivity of the skin to sunlight.
Slovenian: Pradofloksacin lahko poveča občutljivost kože na sočno svetlobo.
English: In case of contact with the skin, rinse off with water.
Slovenian: V primeru stika s kožo, sperite z vodo.
English: In order to avoid cross-contamination, the same syringe should not be used for different animals.
Slovenian: Da bi se izognili navzkrižni kontaminaciji, ne uporabite ene in iste brizge pri različnih živalih.
English: Although pradofloxacin has in-vitro activity against a wide range of Gram-positive and Gramnegative organisms, including anaerobic bacteria, this veterinary medicinal product should only be used for the approved indications (see section 4.2) and in accordance with the prudent use recommendations in section 4.5 of this SPC.
Slovenian: Kljub temu, da pradofloksacin in vitro deluje na številne grampozitivne in gramnegativne organizme ter anaerobne bakterije, se to zdravilo lahko uporablja le za odobrene indikacije (glej poglavje 4.2) in v skladu s priporočili o preudarni uporabi v poglavju 4.5 tega SPC.
English: Date of last renewal: 07/01/2016
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 07/01/2016
English: Veraflox should only be used in severe cases of periodontal disease.
Slovenian: Veraflox se lahko uporablja le v hudih primerih parodontalne bolezni.
English: The bioavailability of the veterinary medicinal product is at least 60%.
Slovenian: Biološka razpoložljivost tega zdravila za uporabo v veterinarski medicini je najmanj 60 %.
English: When the dose requires a half tablet to be used the remaining portion should be given at the next administration.
Slovenian: Če odmerjanje zdravila zahteva polovico tablete, je potrebno drugo polovico tablete uporabiti pri naslednjem odmerku.
English: The duration of the treatment depends on the nature and severity of the infection and on the response to treatment.
Slovenian: Trajanje zdravljenja je odvisno od vrste in težavnosti okužbe ter samega poteka zdravljenja.
English: Pyoderma occurs mostly secondary to an underlying disease, thus, it is advisable to determine the underlying cause and to treat the animal accordingly.
Slovenian: Piodermija je največkrat posledica temeljne bolezni, zato je potrebno ugotoviti njen vzrok in žival temu primerno zdraviti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/04/2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 12/04/2011
English: The rapidity and extent of bacterial killing are directly proportional to the drug concentration.
Slovenian: Hitrost in obseg protimikrobnega učinka pradofloksacina sta neposredno sorazmerna s koncentracijo zdravila.
English: SPECIAL WARNING(S), IF NECESSARY Avoid introduction of contamination during use.
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Preprečite kontaminacijo med dajanjem.
English: Number of 15 mg tablets
Slovenian: Število 15 mg tablet
English: Pradofloxacin
Slovenian: Pradofloksacin
English: Tablets.
Slovenian: Tablete
English: For most infections the following treatment courses will be sufficient:
Slovenian: Pri večini okužb traja zdravljenje naslednje časovno obdobje:
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Slovenian: Vsi mehanizmi vplivajo na zmanjševanje občutljivosti bakterij na flourokinolone.
English: Interactions with other medicinal products and other forms of interaction: There are some medicines that you should not give to your animal during treatment because if given together they might cause serious adverse effects.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: V času zdravljenja živali ne smete dajati nekaterih zdravil, ker sočasno dajanje lahko povzroči resnejše stranske učinke.
English: Bacterial species
Slovenian: Vrste bakterij
English: Pradofloxacin concentrations in skin homogenates of dogs exceed those in serum by up to seven times.
Slovenian: Koncentracije pradofloksacina v kožnem homogenatu psa presegajo koncentracije v plazmi do sedem krat.
English: In vitro plasma protein binding is low (35%).
Slovenian: V raziskavah in vitro je vezava na plazemske beljakovine dokaj nizka (35%).
English: Amberlite IRP 64 Sorbic acid Ascorbic acid Xanthan gum Propylene glycol Vanilla flavour Purified water
Slovenian: Amberlite IRP 64 Sorbinska kislina Askorbinska kislina Ksantan guma Propilen glikol Okus vanilije Prečiščena voda
English: In vitro plasma protein binding is low (30%).
Slovenian: V raziskavah in vitro je vezava na plazemske beljakovine dokaj nizka (30%).
English: Vomiting and soft faeces may be symptoms of overdose.
Slovenian: Bruhanje in mehko blato sta lahko simptoma prevelikega odmerjanja.
English: ADVICE ON CORRECT ADMINISTRATION The oral suspension should be given by direct oral administration as shown below:
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Dajemo direktno peroralno kot je prikazano na slikah spodaj: