FrancophonIA/ELRC3.0 huggingface dataset:
English: Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Croatian: U bolesnika koje primaju docetaksel, doksorubicin i ciklofosfamid (TAC) kao adjuvantnu terapiju u liječenju karcinoma dojke treba razmotriti primarnu profilaksu s G-CSF.
English: Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/ odynophagia (G3/4: 0.7%)
Croatian: proljev (G3/4: 6,8%);, ezofagitis/disfagija/odin ofagija (G3/4: 12,0%), konstipacija (G3/4:
English: Very common adverse reactions Common adverse reactions subcutaneous tissue disorders disorders
Croatian: Vrlo česte nuspojave Česte nuspojave Manje česte nuspojave
English: Asthenia (severe: 9.9%); Fluid retention (severe: 0.7%);
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija (teška: 9,9%), retencija tekućine (teška: 0,7%), vrućica (G3/4: 1,2%)
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Croatian: Uputa o lijeku: Informacije za bolesnika DOCETAXEL KABI 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
English: Cystoid macular oedema (CMO) has been reported in patients treated with docetaxel.
Croatian: U bolesnika liječenih docetakselom prijavljen je cistični edem makule.
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
Croatian: NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (DOCETAXEL KABI 120 mg/6 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Croatian: kožna toksičnost (G3/4: 0,6%), poremećaji noktiju (G3/4: 0,4%)
English: Arrhythmia (G3/4: 0.2%)
Croatian: Srčani poremećaji aritmija (G3/4: 0,2%)
English: After 10 years of follow-up in GEICAM 9805 STUDY, acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Croatian: Nakon 10 godina praćenja u ispitivanju GEICAM 9805 akutna leukemija pojavila se u 1 od 532 bolesnika (0,2%) u TAC skupini.
English: Number of patients Median survival (months) 95% CI
Croatian: Medijan preživljenja(mjeseci) 95% CI
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² single agent
Croatian: Tablični popis nuspojava kod karcinoma dojke za DOCETAXEL KABI 100 mg/m² u monoterapiji
English: Tabulated list of adverse reactions in gastric adenocarcinoma center for DOCETAXEL KABI 75 mg/m² in combination with cisplatin and 5-fluorouracil
Croatian: Tablični popis nuspojava za DOCETAXEL KABI 75 mg/m2 u kombinaciji s cisplatinom i 5
English: Tabulated list of adverse reactions in non-small cell lung cancer for DOCETAXEL KABI 75 mg/m² single agent
Croatian: Tablični popis nuspojava kod karcinoma nemalih stanica pluća za DOCETAXEL KABI 75 mg/m² u monoterapiji
English: **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Croatian: **Log-rank test *** Hi-kvadrat test
English: Diarrhoea (G3/4: 4%); Nausea (G3/4: 4%); Vomiting (G3/4: 3%)
Croatian: mučnina (G 3/4: 4%), povraćanje (G 3/4:
English: Anaemia (G3/4: 3%); Neutropenia (G3/4: 59.2%);
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G3/4: anemija (G3/4: 9,2%), trombocitopenija (G3/4: 5,2%)
English: This regimen is administered every 3 weeks for 4 cycles.
Croatian: Liječenje se ponavlja svaka 3 tjedna u 4 ciklusa.
English: Peripheral sensory neuropathy (G3/4: 1.2%)
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: 1,2%), disgeuzija (G3/4: 0%)
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Croatian: hipotenzija (G3/4: 0%), flebitis (G3/4: 0%)
English: Cancer pain (G3/4: 0.6%)
Croatian: bol izazvana karcinomom (G3/4: 0,6%)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/770/005
English: Cancer pain (G3/4: 1.2%)
Croatian: bol izazvana karcinomom (G3/4: 1,2%)
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial with 160 mg/8 ml METHOD AND ROUTE(S) OF ADMINISTRATION Ready to add to infusion solution.
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 1 bočica s 160 mg/8 ml
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Croatian: Proljev 4. stupnja Prva epizoda: smanjiti doze docetaksela i 5-FU za 20 % Druga epizoda: prekinuti liječenje
English: Alopecia (G3/4: 10.9%) Rash pruritic; Dry skin;
Croatian: Poremećaji kože i potkožnog tkiva alopecija (G3/4: 0,9%) osip praćen svrbežom, suhoća kože, eksfolijacija kože (G3/4:
English: Hazard ratio: (95% CI) **p-value
Croatian: Omjer hazarda: (95% CI) **p- vrijednost
English: Alopecia; Nail disorders (no severe)
Croatian: Poremećaji kože i potkožnog tkiva alopecija, poremećaji noktiju (ne teški)
English: Preparation of the infusion solution
Croatian: Priprema otopine za infuziju
English: Hypersensitivity (G3/4: 0.6%)
Croatian: Poremećaji imunološkog sustava preosjetljivost (G3/4: 0,6%)
English: arm.
Croatian: ciklusa.
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median followup time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Croatian: U ispitivanju GEICAM 9805, alopecija koja je počela tijekom perioda liječenja i dalje bila prisutna tijekom perioda praćenja zabilježena je u 49 bolesnika (9,2%) u TAC skupini i u 35 bolesnika (6,7%) u FAC skupini.
English: On the basis of the questions raised by the Netherlands the points to be considered by the CHMP were:
Croatian: Na temelju pitanja postavljenog od strane Nizozemske, CHMP razmatrao je sljedeće točke:
English: Further 10 patients out of 176 reported signs of physical dependence as a result of a specific follow-up visit 4 weeks after the end of the extension phase.
Croatian: Nadalje 10 bolesnika od 176 prijavilo je znakove fizičke ovisnosti kao rezultat specifičnog kontrolnog pregleda 4 tjedna nakon završetka produljene faze.
English: However, the protocol did not stipulate dose tapering and in the majority of these subjects no tapering had been performed.
Croatian: No, u protokolu nije navedeno postupno smanjivanje doze, a u većine ovih subjekata nije provedeno postupno smanjivanje doze.
English: • The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
Croatian: Njemačka je pokrenula postupak upućivanja u skladu sa člankom 13(2) Uredbe EZ br. 1234/2008.
English: Therefore, further justification that the different criteria for approval on the basis of one pivotal trial should be provided by the applicant.
Croatian: Stoga, podnositelj zahtjeva treba dostaviti daljnje opravdanje za različite kriterije za odobrenje na osnovu jednog pivotalnog ispitivanja.
English: Scientific discussion
Croatian: Znanstvena rasprava
English: There is a lack of confirmatory evidence regarding the maintenance of efficacy and the long-term safety, which has not been provided by the open-label extension study phase, due to its methodological limitations.
Croatian: Prisutan je nedostatak potvrdnih dokaza u vezi s održavanjem djelotvornosti i dugoročne sigurnosti, koji nisu bili dostavljeni fazom otvorenog proširenog ispitivanja zbog metodologijskih ograničenja.
English: The available clinical data of only one single, short term, pivotal trial are considered insufficient considering the risks.
Croatian: Dostupni klinički podaci samo jednog jednostrukog, kratkoročnog, pivotalnog ispitivanja smatraju se nedostatnima za razmatranje rizika.
English: In addition, clear instructions have been proposed for section 4.2 of the SmPC to re-evaluate the benefits and risks in individual RLS patients regularly every 3 months and to consider a discharge regimen by gradual tapering before treatment is continued beyond 1 year.
Croatian: Nadalje, jasne su upute predložene za dio 4,2 SPC-a za ponovnu ocjenu koristi i rizika u individualnih bolesnika s RLS-om redovito svaka 3 mjeseca kao i za razmatranje režima pražnjenja postupnim smanjivanjem doze prije nego što se liječenje nastavi dulje od godine dana.
English: The review of ‘opioid dependence' revealed that during the extension phase two reports of withdrawal symptoms were obtained as part of the standard adverse event reporting procedures.
Croatian: Pregled „opioidne ovisnosti“ otkrio je da su tijekom produljene faze zaprimljena dva izvještaja o simptomima ustezanja kao dio standardnog postupka prijavljivanja nuspojava.
English: Oxynal 10mg/5mg, 20mg/10mg prolonged-release tablets and Targin 5mg/2.5mg, 10mg/5mg, 20mg/10mg, 40mg/20mg prolonged-release tablets and associated names (OXN PR) are fixed combination products of oxycodone hydrochloride and naloxone hydrochloride.
Croatian: Oxynal 10mg/5mg, 20mg/10mg tablete s produljenim otpuštanjem i Targin 5mg/2.5mg, 10mg/5mg, 20mg/10mg, 40mg/20mg tablete s produljenim otpuštanjem i povezani nazivi (OXN PR) su fiksne kombinacije lijekova koji sadrže oksikodon hidroklorid i nalokson hidroklorid.
English: Conclusion
Croatian: Zaključak
English: 97% of patients completing the double-blind controlled study entered the extension phase.
Croatian: 97% bolesnika, koji su završili dvostruko slijepo kontrolirano ispitivanje, uvršteno je u produljenu fazu.
English: OXN PR is currently indicated in “severe pain, which can be adequately managed only with opioid analgesics”.
Croatian: OXN PR je trenutno indiciran za „ozbiljnu bol, kojom se može upravljati na primjeren način samo opioidnim analgeticima“.
English: Based on clinical experience and clinical guidance, the potential abuse and misuse of opioid analgesics in the controlled pain therapy is considered low.
Croatian: Na temelju kliničkog iskustva i kliničkog vođenja, potencijalna zlouporaba i potencijalna neispravna uporaba opioidnih analgetika u kontroliranoj terapiji boli smatra se niskom.
English: Even using a very conservative statistical approach, the magnitude of effect (decrease in mean IRLS of 5.9 points compared to placebo) was in line with or even slightly better than the results found in the placebo-controlled studies with dopamine agonists approved as first line treatment.
Croatian: Čak i primjenom vrlo konzervativnog statističkog pristupa, veličina djelovanja (smanjenje u srednjoj vrijednosti IRLS-a od 5,9 bodova u odnosu na placebo) bila je u skladu ili čak malo bolje od rezultata utvrđenih u placebo kontroliranim ispitivanjima s agonistima dopamina odobrenima za terapiju prve linije.
English: The treatment effect during the extension phase was independent from treatment during the pivotal study.
Croatian: Djelovanje liječenja tijekom produljene faze bilo je nezavisno od liječenja tijekom pivotalnog ispitivanja.
English: The results of the pivotal phase III clinical study are considered robust and consistent with respect to primary and secondary efficacy parameters (addressing severity and impact of the disease and quality of life) as well as with respect to responder rates and various subgroup analyses.
Croatian: Rezultati pivotalne faze III kliničkog ispitivanja smatraju se robusnima i konzistentnima u odnosu na parametre primarne i sekundarne učinkovitosti (rješavanje problema ozbiljnosti i utjecaja bolesti na kvalitetu života) kao i u odnosu na broj osoba koje su odgovorile na terapiju i analize različitih podgrupa.
English: In addition, in order to further increase safety and appropriate use of OXN PR in the IRLS indication, the maximum daily dose has been limited to 60 mg/day.
Croatian: Nadalje, kako bi se još više povećala sigurna i primjerena uporaba lijeka OXN PR za indikaciju IRLS-a, maksimalna dnevna doza ograničena je na 60 mg/danu.
English: Warning regarding somnolence/sleep attacks and ability to drive/operating machinery has been added to the product information in accordance with the information given in the respective product information of dopaminergic substances approved in the RLS indication.
Croatian: Upozorenja u vezi somnolencije/napadaja spavanja i sposobnosti upravljanja vozilom/rada sa strojevima dodatna su u informacije o proizvodu u skladu s informacijama navedenima u odgovarajućim informacijama o proizvodu za dopaminergičke lijekove odobrene za indikaciju RLS-a.
English: Overall summary of the scientific evaluation of Oxynal and Targin and associated names (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene lijekova Oxynal i Targin i povezanih naziva (vidjeti Dodatak I)
English: The CHMP acknowledged the methodological limitations of the open label study however the CHMP considered that reasonable justifications for maintenance of effect up to 52 weeks of treatment were provided by the MAH.
Croatian: CHMP je potvrdio metodologijska ograničenja otvorenog ispitivanja, no CHMP je zaključio da je nositelj odobrenja dostavio utemeljena opravdanja za održavanje djelovanja do 52 tjedna liječenja.
English: Further caution is included in the section 4.4 of the SmPC when OXN PR is administered to elderly irrespective of the indication.
Croatian: Daljnji oprezi uključeni su u dio 4.4. SPC-a samo ako se OXN PR primjenjuje u starijih osoba bez obzira na indikaciju.
English: In addition, the CHMP highlighted the unmet medical need in the treatment of severe to very severe RLS.
Croatian: Nadalje, CHMP je istaknuo neudovoljenu medicinsku potrebu za liječenje teškog do vrlo teškog RLS-a.
English: A detailed review of safety data from both the double-blind phase and extension phase (OXN3502/S) was conducted.
Croatian: Proveden je detaljan pregled sigurnosnih podataka iz dvostruko slijepe faze i produljene faze (OXN3502/S).
English: The results at the end of the extension phase at week 52 showed a further slight improvement of the IRLS sum score compared to the results towards the end of 12-week double-blind phase.
Croatian: Rezultati po završetku produljene faze u 52. tjednu pokazali su daljnje neznatno poboljšanje zbirnog rezultata IRLS-a u usporedbi s rezultatima dobivenima pred završetak 12-tjedne dvostruko slijepe faze.
English: As requested during the CMDh procedure, the applicant has further made a commitment to perform a drug utilisation study (DUS) and to update the risk management plan (RMP) subsequently to approval of the DUS in order to address concerns based on uncertainties that data of the clinical study including the long-term extension might not fully characterise a possible risk of tolerance, dependence and drug abuse in long-term use in IRLS.
Croatian: Kako je zatraženo tijekom postupka CMDh-a, podnositelj zahtjeva nadalje se obvezao da će provesti ispitivanje iskoristivosti lijeka (DUS) te da će ažurirati plan upravljanja rizicima (RMP) po odobrenju DUS-a kako bi se uklonile zabrinutosti temeljene na nesigurnostima da podaci kliničkog ispitivanja, uključujući i dugoročnog produljenja, vjerojatno u potpunosti ne karakteriziraju mogući rizik od tolerancije, ovisnosti i zlouporabe droga u dugoročnoj primjeni u slučaju IRLS-a.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: The CHMP noted that there is evidence from the literature that the endogenous opioid system is involved in the pathogenesis of RLS on a spinal and supraspinal level and therefore there is a plausible rationale to justify the use of opioids for treatment of RLS 1,2.
Croatian: CHMP je napomenuo da postoje dokazi iz literature da je endogeni opioidni sustav uključen u patogenozu RLS-a na spinalnoj i supraspinalnoj razini te stoga postoji plauzibilan razlog za opravdavanje primjene opioida za liječenje RLS-a 1,2.
English: The CHMP noted that the mean daily dose of OXN PR used in the extension phase was almost identical (and even slightly lower) compared to the mean daily dose used in the double-blind phase (18.12 mg vs. 22.62 mg), with no difference in mean doses in the extension phase between the subgroups previously treated with OXN PR or placebo.
Croatian: CHMP je zaključio da je srednja dnevna doza lijeka OXN PR korištena u produljenoj fazi gotovo identična (pa čak i malo niža) u usporedbi sa srednjim dnevnim dozama korištenima u dvostrukoj slijepoj fazi (18,12 mg u odnosu na 22,62 mg), bez razlike u srednjim dozama u produljenoj fazi između podgrupa koje su prethodno liječene lijekom OXN PR ili placebom.
English: The mean ILRS score at the end of the open extension study was 9.72 and corresponds to a mild symptom severity.
Croatian: Srednji rezultat ILRS-a na završetku otvorenog produljenog ispitivanja iznosio je 9,72, a odgovarao je ozbiljnosti blagih simptoma.
English: No convincing scientific evidence has been provided in the perspective of public health that the benefit of the fixed dose combination of oxycodone/naloxone in the treatment of idiopathic restless leg syndrome (IRLS) outweighs the expected adverse effects that are associated with the use of strongopioids in doses equipotent to doses up to 90 mg of oral morphine; dependence, withdrawal, augmentation, misuse and abuse.
Croatian: Nisu dostavljeni uvjerljivi znanstveni dokazi iz perspektive javnoga zdravstva da koristi kombinacije fiksnih doza oksikodona/naloksona u liječenju idiopatskog sindroma nemirnih nogu (IRLS-a) nadmašuju očekivane nuspojave koje se povezuju s primjenom snažnih opioida u dozama ekvipotentnima s dozama do 90 mg oralnog morfija; ovisnost, ustezanje, augumentacija, neispravna uporaba i zlouporaba.
English: Compared to other opioids, a lower potential for psychological dependence and abuse is further expected with OXN PR, as it is a prolonged release formulation whereas it is currently accepted knowledge that the risk of psychological dependence increases with faster drug release.
Croatian: U usporedbi s drugim opioidima, nizak potencijal za psihološku ovisnost i zlouporabu se nadalje očekuje i s lijekom OXN PR, budući da ima formulaciju s produljenim otpuštanjem, pri čemu je trenutno prihvaćeno saznanje da se rizik od psihološke ovisnosti povećava s bržim otpuštanjem lijeka.
English: Therefore, the Committee recommended the granting of the variation to the terms of the marketing authorisations for the medicinal products referred to in Annex I, for which the valid summary of product characteristics, labelling and package leaflets remain as per the final versions achieved during the Coordination group procedure with amendments as mentioned in Annex III.
Croatian: Stoga, Odbor je preporučio odobravanje izmjene uvjeta odobrenja za stavljanje lijeka u promet za lijekove navedene u Dodatku I, za koje važeći sažetak opisa svojstava proizvoda, etiketa i uputa o lijeku ostaje u skladu s konačnim verzijama usuglašenima tijekom postupka Koordinacijske grupe zajedno s dopunama navedenima u Dodatku III.
English: The RLS treatment with OXN PR should be supervised by a clinician with experience in the management of IRLS.
Croatian: Liječenje RLS-a lijekom OXN PR treba nadzirati kliničar iskusan u upravljanju IRLS-om.
English: The safety profile was also considered to be in-line with the experience of OXN PR used for the treatment of pain where adverse events are also more frequently reported at the beginning of therapy.
Croatian: Zaključeno je da je sigurnosni profil također u skladu s iskustvom lijeka OXN PR korištenim za liječenje boli u slučajevima kada su nuspojave češće prijavljene na početku terapije.
English: In addition, further improvements in the patient's condition by the end of the extension phase compared to the end of the double-blind phase was observed in the secondary efficacy parameters, including reduction in the severity of illness, improvements in sleep, RLS related pain and quality of life, respectively.
Croatian: Nadalje, u sekundarnim parametrima djelotvornosti uočena su daljnja poboljšanja u stanju bolesnika do kraja produljene faze u usporedbi sa završetkom dvostruko slijepe faze, uključujući smanjenje u ozbiljnosti bolesti, poboljšanju u spavanju, boli povezanom s RLS-om, odnosno kvaliteti života.
English: Therefore, the CHMP endorsed that the use OXN PR as a prolonged-release formulation of oxycodone and naloxone reduces the risk of abuse or misuse.
Croatian: Stoga, CHMP je potvrdio da primjena uporabe lijeka OXN PR kao formulacije oksikodona i naloksona s produljenim otpuštanjem smanjuje rizik od zlouporabe ili neispravne uporabe.
English: The CHMP also took note of the risks of iatrogenic drug dependence, drug abuse or misuse, augmentation, tolerance, and psychological dependence associated with Oxynal and Targin and associated names.
Croatian: CHMP je također istaknuo rizike iatrogenske ovisnosti lijeka, zlouporabe lijeka ili neispravne primjene, augmentacije, tolerancije i psihološke ovisnosti povezane s lijekovima Oxynal i Targin te povezanim nazivima.
English: The maintenance of treatment effect was investigated in the open extension phase of the pivotal study.
Croatian: Održavanje djelovanja terapije istraženo je u otvorenoj produljenoj fazi pivotalnog ispitivanja.
English: In order to demonstrate the efficacy and safety of OXN PR in the symptomatic treatment of patients with moderate to severe idiopathic restless legs syndrome insufficiently treated with dopaminergic therapy, the application dossier was based on a pivotal phase III clinical study (No OXN 3502) and open label extension study phase (No OXN 3502S).
Croatian: Kako bi se demonstrirala djelotvornost i sigurnost OXN PR u simptomatičnom liječenju bolesnika s umjerenim do ozbiljnim idiopatskim sindromom nemirnih nogu nedostatno liječenih dopaminergičkom terapijom, dosje zahtjeva temeljen je na pivotalnoj fazi II kliničkog ispitivanja (br. OXN 3502) i proširenoj fazi otvorenog ispitivanja (br. OXN 3502S).
English: Overall, the CHMP considered that benefits of Oxynal and Targin and associated names in the sought indication outweigh the risks, taking into account the additional risk minimisations measures which had already been agreed at CMD(h) and the changes recommended to the product information.
Croatian: Načelno, CHMP smatra da koristi lijekova Oxynal i Targin te povezanih naziva nadmašuju rizike u zatraženoj indikaciji, uzimajući u obzir dodatne mjere za minimiziranje rizika koje su već usuglašene sa CMD(h)-om kao i promjene preporučene za informacije o proizvodu.
English: There were no notable differences in the frequency of adverse events, severe adverse events and serious adverse events (overall and treatment-related) for young vs. elderly subjects as well as for females vs. males.
Croatian: Nema uočljivih razlika u učestalosti nuspojava, teških nuspojava i ozbiljnih nuspojava (cjelokupnih i onih povezanih s liječenjem) za mlade u odnosu na starije subjekte, te kako za žene tako i za muškarce.
English: The CHMP is of the opinion that the mean daily dose of 20mg/10mg oxycodone hydrochloride/naloxone used in the pivotal trial and being considerably lower than the doses needed in the pain indication should be mentioned in the SmPC to guide dosing.
Croatian: CHMP je mišljenja da se srednja dnevna doza od 20mg/10mg oksikodon hidroklorida/naloksona korištena u pivotalnom ispitivanju, te budući da je značajno niža od doza potrebnih za indikaciju boli treba spomenuti u SPC-u za vođenje doziranja.
English: As the reference and concerned member states were not able to reach an agreement in respect of the variation, on 2 May 2014, Germany triggered a referral under Article 13(2) of Regulation EC No
Croatian: Budući da referentne države članice i države članice u postupku nisu uspjele postići dogovor u vezi s izmjenom, dana 2. svibnja 2014.