FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the cross-study population pharmacokinetic analysis, the clearance of daclizumab beta is 0.212 L/day with a terminal half-life value of approximately 21 days.
Slovenian: Na podlagi medštudijske analize populacijske farmakokinetike je očistek daklizumaba beta 0,212 l/dan z vrednostjo končnega razpolovnega časa približno 21 dni.
English: In two 9 month studies conducted in cynomolgus monkeys daclizumab beta was subcutaneously administered at bi-weekly doses of 10-200 mg/kg.
Slovenian: V dveh 9-mesečnih študijah, izvedenih na opicah vrste cynomolgus, so daklizumab beta subkutano dajali dvakrat tedensko v odmerkih od 10 do 200 mg/kg.
English: As an IgG1 monoclonal antibody, daclizumab beta is expected to undergo catabolism to peptides and amino acids in the same manner as endogenous IgG.
Slovenian: Kot monoklonsko protitelo IgG1 se pričakuje, da se daklizumab beta katabolično presnovi na peptide in aminokisline na enak način kot endogeni IgG.
English: Daclizumab beta is produced in a mammalian cell line (NS0) by recombinant DNA technology.
Slovenian: Daklizumab beta se pridobiva iz celične kulture sesalcev (NS0) s tehnologijo rekombinantne DNA.
English: Based on the cross-study population pharmacokinetic analysis, body weight accounted for less than 40% of the inter-patient variability in daclizumab beta clearance.
Slovenian: Na podlagi medštudijske analize populacijske farmakokinetike je bila telesna masa vzrok za manj kot 40 % variabilnost med bolniki pri očistku daklizumaba beta.
English: Based on the cross-study population pharmacokinetic analysis, the steady-state volume of distribution of daclizumab beta is 6.34 L in a patient with a body weight of 68 kg (approximate median of evaluated patients).
Slovenian: Na podlagi medštudijske analize populacijske farmakokinetike je volumen porazdelitve v stanju dinamičnega ravnovesja daklizumaba beta 6,34 l pri bolniku s telesno maso 68 kg (približno mediana ocenjenih bolnikov).
English: 1.0 point improvement p=0.0008
Slovenian: izboljšanje za 1,0 točko p=0,0008
English: There was no apparent correlation of anti-drug antibodies or neutralising antibodies development to clinical response, adverse reactions, or pharmacodynamic profile of daclizumab beta.
Slovenian: Med razvojem protiteles proti zdravilu ali nevtralizirajočih protiteles in kliničnim odzivom, neželenimi učinki ali farmakodinamičnim profilom daklizumaba beta ni bilo očitne korelacije.
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to
Slovenian: • Zdravilo je priporočljivo shranjevati v nadzorovanem hladilniku med 2 °C in 8 °C v zaprti originalni škatli za zagotovitev zaščite pred svetlobo.
English: Within the studied regimens of daclizumab beta 150 mg and 300 mg administered subcutaneous every 4 weeks in MS patients, there was no clear relationship between daclizumab beta exposure and clinical efficacy endpoints (ARR, T2 lesions and Gd-enhancing lesions) or safety endpoints of interest (serious infection status, moderate or severe cutaneous adverse reaction, and AST/ALT > 5 times the ULN).
Slovenian: Znotraj preučevanih režimov subkutanega odmerjanja daklizumaba beta 150 mg in 300 mg vsake 4 tedne pri bolnikih z multiplo sklerozo ni bilo jasnega razmerja med izpostavljenostjo daklizumabu beta in opazovanimi dogodki klinične učinkovitosti (ARR, lezije T2 in lezije, vidne z gadolinijem), ali izbranimi opazovanimi dogodki varnosti (resne okužbe, zmerni ali resni kožni neželeni učinki in vrednosti AST/ALT > 5-kratna ULN).
English: Cumulatively, 24 cases of colitis have been retrieved from clinical trials.
Slovenian: Kumulativno so v kliničnih preskušanjih ugotovili 24 primerov kolitisa.
English: At steady state, daclizumab beta mean maximum serum concentration (Cmax), minimum serum concentration (Cmin) and area under the serum concentration-time curve over the dosing interval (AUCtau) values were approximately 30 micrograms/mL, 15 micrograms/mL and 640 day*micrograms/mL, respectively, with inter-patient variability (% CV) of approximately 40%.
Slovenian: V stanju dinamičnega ravnovesja so bile vrednosti povprečne največje koncentracije v serumu (cmax), najmanjše koncentracije v serumu (cmin) in površina pod časovno krivuljo koncentracije v serumu v intervalu odmerjanja (AUCtau) daklizumaba beta približno 30 mikrogramov/ml, 15 mikrogramov/ml in 640 dan*mikrogramov/ml, s približno 40-odstotno variabilnostjo med bolniki (% CV).
English: Carcinogenicity studies with daclizumab beta have not been conducted.
Slovenian: Študij kancerogenosti z daklizumabom beta niso izvajali.
English: Daclizumab beta modulates IL-2 signalling by blocking CD25dependent, high-affinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Slovenian: Daklizumab beta modulira sporočanje IL-2 z zaviranjem od CD25 odvisnega sporočanja receptorjev IL-2 z visoko afiniteto, kar povzroči višje ravni razpoložljivega IL-2 za sporočanje prek receptorjev IL-2 z zmerno afiniteto.
English: • Patients with 2 or more relapses in 1 year, and with 1 or more Gd-enhancing lesions on brain
Slovenian: • bolniki z 2 ali več recidivi v 1 letu in z 1 ali več lezij, vidno z gadolinijem, pri MR slikanju
English: Potential adverse reactions beyond this level are expected to be consistent with the safety profile for daclizumab beta in MS patients.
Slovenian: Pričakuje se, da bodo možni neželeni učinki nad to ravnijo v skladu z varnostnim profilom za daklizumab beta pri bolnikih z multiplo sklerozo.
English: In patients with neutralising antibodies, daclizumab beta clearance was increased on average by 19% (see section 5.2).
Slovenian: Pri bolnikih z nevtralizirajočimi protitelesi se je očistek daklizumaba beta povprečno povečal za 19 % (glejte poglavje 5.2).
English: Twelve cases of sarcoidosis confirmed by health-care professionals were reported from clinical trials cumulatively.
Slovenian: Kumulativno so v kliničnih preskušanjih poročali o dvanajstih primerih sarkoidoze, ki so jih potrdili zdravstveni delavci.
English: Daclizumab beta clearance in patients who developed neutralising antibodies was, on average, 19% higher (see section 4.8 Immunogenicity).
Slovenian: Očistek daklizumaba beta pri bolnikih, pri katerih se razvijejo nevtralizirajoča protitelesa, je bil povprečno 19 % večji (glejte poglavje 4.8
English: Following subcutaneous administration of daclizumab beta 150 mg every 4 weeks, steady-state serum daclizumab beta concentrations were achieved by the 4th dose and daclizumab beta accumulated to a level approximately 2.5-fold compared to a single dose.
Slovenian: Po subkutani uporabi daklizumaba beta 150 mg vsake 4 tedne je bilo stanje dinamičnega ravnovesja koncentracij daklizumaba beta v serumu doseženo do 4. odmerka; daklizumab beta se je akumuliral do ravni, ki je bila približno 2,5-kratnik v primerjavi z enkratnim odmerkom.
English: There is also a plausible mechanism of action for the development of sarcoidosis due to the immunomodulatory effects of daclizumab beta and involvement of daclizumab beta in the origin of other immune-mediated events.
Slovenian: Obstaja tudi verjeten mehanizem delovanja za razvoj sarkoidoze zaradi imunomodulacijskih učinkov daklizumaba beta in vpletenosti daklizumaba beta v nastanek drugih imunsko posredovanih učinkov.
English: • Prior to treatment (re)start, confirmation of: o A discussion between the physician and the patient about the risk of serious and potentially fatal hepatic injury and the unpredictable nature of such reactions and about the possibility of having to switch treatment in case of levels of ALT or o Patient understanding of the risk information provided; o Receipt of a copy of the acknowledgement form;
Slovenian: o pogovora med zdravnikom in bolnikom o tveganju za resne in potencialno smrtne poškodbe jeter in nepredvidljivi naravi takih reakcij in možnosti zamenjave zdravila v primeru, ko je raven AST ali ALT >3-krat ULN; o da bolnik razume posredovane informacije o tveganju;
English: Sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections
Slovenian: natrijev sukcinat, sukcinska kislina, natrijev klorid, polisorbat 80, voda za injekcije raztopina za injiciranje
English: Do not lift your pen off your injection site until the clicking sounds stop and you see green ticks in the injection status window.
Slovenian: injiciranja, dokler zvok klikanja ne preneha injiciranje z mesta injiciranja, dokler zvok klikanja ne preneha in v oknu za stanje injiciranja ne zagledate zelenih kljukic.
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab beta in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Slovenian: Ključni učinek te modulacije poti IL-2, ki je morda povezan s terapevtskimi učinki daklizumaba beta pri multipli sklerozi, vključuje selektivni antagonizem odzivov aktiviranih celic T in ekspanzijo imunoregulacijskih naravnih celic ubijalk CD56bright, za katere se je pokazalo, da selektivno zmanjšujejo aktivirane celice T. Ti imunomodulirajoči učinki daklizumaba beta skupaj naj bi zmanjševali patologijo osrednjega živčnega sistema pri multipli sklerozi in s tem zmanjševali pojavnost recidivov in napredovanje bolezni.
English: Do not use Zinbryta - if you have previously had a serious allergic reaction to any form of daclizumab, or any of the other ingredients of this medicine listed in section 6.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Zinbryta Ne uporabljajte zdravila Zinbryta - če ste že prej imeli resne alergijske reakcije na katero koli obliko daklizumaba ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: Elimination As an IgG1 monoclonal antibody, daclizumab beta is not expected to undergo renal elimination.
Slovenian: Izločanje Kot monoklonsko protitelo IgG1 se ne pričakuje, da bi se daklizumab beta izločal skozi ledvice.
English: There is a plausible mechanism of action for the development of this colitis due to immunomodulatory properties of daclizumab beta and involvement of daclizumab beta in the origin of other immune-mediated events.
Slovenian: Obstaja verjeten mehanizem delovanja za razvoj tega kolitisa zaradi imunomodulacijskih lastnosti daklizumaba beta in vpletenosti daklizumaba beta v nastanek drugih imunsko posredovanih učinkov.
English: • Check that the Zinbryta medicine is colourless or slightly yellow (See Figure syringe if the liquid is cloudy, or has
Slovenian: • Preverite, da je zdravilo Zinbryta brezbarvno ali rumenkasto (glejte sliko E).
English: The causal relationship between daclizumab beta and sarcoidosis is considered possible.
Slovenian: Vzročna povezava med daklizumabom beta in sarkoidozo velja za možno.
English: • Patients who had failed to respond to a full and adequate course (at least 1 year) of prior DMT treatment, having had at least 1 relapse in the previous year while on therapy, and at least 9 T2 hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or having an unchanged or increased relapse rate in the prior year as compared to the previous 2 years.
Slovenian: DMT, ki so imeli vsaj 1 recidiv v prejšnjem letu med zdravljenjem, in vsaj 9 hiperintenzivnih lezij T2 na MR slikanju glave ali vsaj 1 lezijo, vidno z gadolinijem, ali ki so imeli nespremenjeno ali povečano stopnjo recidivov v prejšnjem letu v primerjavi s prejšnjima
English: • increases in body temperature (fever)
Slovenian: • zvišana telesna temperatura
English: Daclizumab beta is not expected to undergo metabolism by hepatic enzymes such as CYP isoenzymes (see section 4.5).
Slovenian: Ne pričakuje se, da bi se daklizumab beta presnavljal z jetrnimi encimi, kot so izoencimi CYP (glejte poglavje 4.5).
English: The active substance in Zinbryta is daclizumab beta.
Slovenian: Učinkovina zdravila Zinbryta je daklizumab beta.
English: Colourless to slightly yellow, clear to slightly opalescent liquid with pH 6.
Slovenian: raztopina za injiciranje (injekcija) Brezbarvna do rumenkasta, bistra do nekoliko motna tekočina s pH 6.
English: Daclizumab beta is not expected to undergo renal elimination or metabolism by hepatic enzymes (see section 4.2).
Slovenian: Ne pričakuje se, da bi se daklizumab beta izločal skozi ledvice ali presnavljal z jetrnimi encimi (glejte poglavje 4.2).
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C Do not place Zinbryta pre-filled syringe back into the refrigerator after warming to room Do not freeze or expose to high temperatures.
Slovenian: • Po potrebi lahko zdravilo Zinbryta do 30 dni shranjujete v zaprti originalni škatli zunaj Zdravila Zinbryta napolnjena injekcijska brizga ne dajajte nazaj v hladilnik, ko se ogreje na Ne zamrzujte in ne izpostavljajte visokim temperaturam.
English: The causal relationship between daclizumab beta and colitis is possible.
Slovenian: Vzročna povezava med daklizumabom beta in kolitisom je možna.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for daclizumab beta, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za daklizumab beta je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke: Sarkoidoza
English: Step 8: Disposing of the used Zinbryta Pre-filled Syringe
Slovenian: 8. korak: Odstranjevanje uporabljenega zdravila Zinbryta napolnjena injekcijska brizga
English: No studies were conducted to evaluate daclizumab beta pharmacokinetics in patients with renal or hepatic impairment.
Slovenian: Študij za ovrednotenje farmakokinetike daklizumaba beta pri bolnikih z ledvično ali jetrno okvaro niso izvedli.
English: Zinbryta is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylaxis or anaphylactoid reactions) to all forms of daclizumab or to any of the excipients in Zinbryta (see section
Slovenian: Zdravilo Zinbryta je kontraindicirano pri bolnikih s hudo preobčutljivostjo v anamnezi (npr. anafilaksija ali anafilaktične reakcije) za vse oblike daklizumaba ali katero koli pomožno snov v zdravilu Zinbryta, navedeno v poglavju 6.1.
English: The exact metabolic pathway for daclizumab beta has not been characterised.
Slovenian: Natančne poti presnavljanja daklizumaba beta niso opisali.
English: Contact your doctor immediately.
Slovenian: Potem morate stopiti v stik z zdravnikom,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zinbryta 150 mg injection daclizumab beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Zinbryta 150 mg injekcija daklizumab beta s.c.
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C
Slovenian: • Po potrebi lahko zdravilo Zinbryta do 30 dni shranjujete v zaprti originalni škatli zunaj hladilnika pri temperaturi do 30 °C.
English: - at least monthly blood tests during treatment, as close as possible before each dose of Zinbryta, and more often if your doctor decides this is necessary - tests for up to 6 months after stopping treatment.
Slovenian: - opravljati vsaj mesečne krvne preiskave med zdravljenjem kolikor mogoče neposredno pred vsakim odmerkom zdravila Zinbryta, ali še pogosteje, če zdravnik odloči, da je to potrebno,
English: Daclizumab beta has not been studied in patients with renal impairment.
Slovenian: Daklizumaba beta niso preučevali pri bolnikih z okvaro ledvic.
English: You will hear the
Slovenian: Slišali boste, ko se bo začelo klikanje.
English: The active substance is daclizumab beta.
Slovenian: Učinkovina je daklizumab beta.
English: Multipack: 3 (3 packs of 1) pre-filled syringes.
Slovenian: Skupno pakiranje: 3 (3 pakiranja z 1) napolnjene injekcijske brizge Skupno pakiranje: 3 (3 pakiranja z 1) napolnjeni injekcijski peresniki subkutana uporaba
English: • decreases in the amount of white blood cells (these will show up in blood tests)
Slovenian: • okužba kože (folikulitis, akne) • zmanjšano število belih krvnih celic (to pokažejo krvne preiskave)
English: Low red blood cell counts (autoimmune haemolytic anaemia): (Uncommon - may affect up to 1 in 100 people)
Slovenian: • spremembe na krvi (anemija), zaradi česar ste lahko šibki Občasni neželeni učinki (Pojavijo se lahko pri največ 1 od 100 bolnikov)
English: Daclizumab beta has not been studied in patients with hepatic impairment.
Slovenian: Daklizumaba beta niso preučevali pri bolnikih z okvaro jeter.
English: General Warnings Do not reuse Zinbryta pre-filled syringe.
Slovenian: Splošna opozorila Zdravila Zinbryta napolnjena injekcijska brizga ne uporabite ponovno.
English: (See Figure J.)
Slovenian: (Glejte sliko I.)
English: • Zinbryta pre-filled syringe is for injecting the medicine under the skin only (subcutaneous).
Slovenian: • Zdravilo Zinbryta napolnjena injekcijska brizga je samo za injiciranje zdravila pod kožo
English: You could get a needle injury or the pen may lock.
Slovenian: Lahko se poškodujete z iglo ali pa se napolnjeni Peresnika ne pokrivajte ponovno, ko je
English: • However, if it is more than 2 weeks from your missed dose, skip the missed dose and take your
Slovenian: • Če od izpuščenega odmerka mineta več kot 2 tedna, pozabljeni odmerek izpustite in si dajte naslednji odmerek na vaš običajni dan.
English: • inflamed or enlarged lymph nodes (lymphadenopathy, lymphadenitis)
Slovenian: • zvišana telesna temperatura (vročina) • vnete ali povečane bezgavke (limfadenopatija, limfadenitis)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 150 mg daklizumaba beta v 1 ml raztopine za injiciranje.
English: • Keep Zinbryta pre-filled syringe and all medicines out of reach and sight of children.
Slovenian: • Zdravilo Zinbryta napolnjena injekcijska brizga in vsa zdravila shranjujte nedosegljiva
English: Immune system disorders
Slovenian: Bolezni imunskega sistema sarkoidoza občasni
English: Solution for injection
Slovenian: Injiciranje zdravila
English: Step 2: Check The Zinbryta Pre-filled Syringe
Slovenian: 2. korak: Preglejte zdravilo Zinbryta napolnjena injekcijska brizga • Preverite rok uporabnosti zdravila
English: Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab beta
Slovenian: Zinbryta 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zinbryta 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku daklizumab beta
English: • Check with your doctor, pharmacist or nurse about the right way to throw away the used syringe.
Slovenian: • O pravilnem načinu odstranjevanja uporabljenega napolnjenega injekcijskega peresnika se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Serious liver problems can occur both early after starting treatment with Zinbryta, any time during treatment and several months after discontinuing treatment.
Slovenian: Resne težave z jetri se lahko pojavijo kmalu po začetku jemanja zdravila Zinbryta,
English: Each pre-filled pen contains a pre-filled syringe, containing 150 mg of daclizumab beta in 1 mL solution for injection.
Slovenian: En napolnjen injekcijski peresnik vsebuje eno napolnjeno injekcijsko brizgo, ki vsebuje 150 mg daklizumaba beta v 1 ml raztopine za injiciranje.
English: Do not place Zinbryta pen back into the refrigerator after warming to room temperature.
Slovenian: Zdravila Zinbryta napolnjen injekcijski peresnik ne dajajte nazaj v hladilnik, ko se ogreje na sobno temperaturo.
English: This includes any possible side effects not listed
Slovenian: Možni neželeni učinki
English: Pad
Slovenian: Kolitis
English: Do not re-cap the pen.
Slovenian: Injekcijskega peresnika ne smete ponovno pokrivati s pokrovčkom.
English: • Very common (≥ 1/10)
Slovenian: • zelo redki (<1/10.000)
English: Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection.
Slovenian: En napolnjen injekcijski peresnik vsebuje 150 mg daklizumaba beta v 1 ml raztopine za injiciranje.
English: psoriasis)
Slovenian: Imunogenost).
English: Do not inject into an area of your body where the skin is irritated, red, bruised, tattooed, infected, or scarred.
Slovenian: Izberite mesto injiciranja na stegnu, trebuhu ali zadnji strani nadlahti (glejte poudarjene o Če nekatere predele pretežko dosežete, prosite usposobljenega negovalca, naj vam Ne injicirajte v telesni predel, kjer je koža modrice, tetovaže, okužbe ali brazgotine.
English: Check the medicine window and make sure the Zinbryta medicine is colourless to
Slovenian: Preverite okno za zdravilo in se prepričajte,
English: The needle cover will extend to cover the needle and will lock (See Figure I).
Slovenian: Varovalo igle bo pokrilo iglo in
English: The procedure started on 2 June 2006.
Slovenian: Postopek se je začel 2. junija 2006.
English: London, 29 May 2007 Doc.Ref.
Slovenian: London, 29. maj 2007 Dok.ref.
English: A Decision was issued by the European Commission on 29 May 2007.
Slovenian: Evropska Komisija je sklep izdala dne 29. maja 2007.
English: The Marketing Authorisation Holder provided supplementary information on 21 September 2006 and 12 January 2007.
Slovenian: Imetnik dovoljenja za promet z zdravilom je dodatne informacije predložil 21. septembra 2006 in 12. januarja 2007.
English: EMEA/144030/2007
Slovenian: EMEA/CHMP/274921/2007
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Xefo and associated names International Non-Proprietary Name (INN): lornoxicam
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA Xefo in z njim povezana imena Mednarodno nelastniško ime (INN): lornoxicam
English: On 16 May 2006 Nycomed Denmark Aps presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Package Leaflets and Labelling of the medicinal product Xefo and associated names.
Slovenian: Družba Nycomed Danmark Aps je dne 16. maja 2006 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, da bi uskladila na nacionalni ravni odobrene povzetke glavnih značilnosti zdravila (SPC), navodila za uporabo ter označevanje zdravila Xefo in z njim povezanih imen.
English: Xefo and associated names, 4mg and 8mg film-coated tablets, 8mg rapid film coated tablet, and 8mg powder and solvent for solution for injection, is a non-steroidal anti-inflammatory drug (NSAID), used for short-term relief of acute mild to moderate pain, symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis.
Slovenian: Zdravilo Xefo in z njim povezana imena, 4 mg in 8 mg filmsko obložene tablete, 8 mg filmsko obložene hitro delujoče tablete ter 8 mg prašek in vehikel za raztopino za injiciranje, je nesteroidno protivnetno zdravilo (NSPVZ), ki se uporablja za kratkotrajno blaženje akutnih blagih do zmerno hudih bolečin, simptomatsko blaženje bolečin in vnetij pri osteoartritisu ter simptomatsko blaženje bolečin in vnetij pri revmatoidnem artritisu.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics of Xefo and associated names approved across EU Member States, with respect to the short-term relief of acute mild to moderate pain, symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis.
Slovenian: Osnova za napotitev so bile razlike v povzetkih glavnih značilnosti za zdravilo Xefo in z njim povezanih imen, ki so bili odobreni v državah članicah EU, v zvezi s kratkotrajnim blaženjem akutnih blagih do zmernih bolečin, simptomatskim blaženjem bolečin in vnetij pri osteoartritisu in simptomatskim blaženjem bolečin in vnetij pri revmatoidnem artritisu.