natgillin/translations-raw huggingface dataset:
Co-administration of 400 mg once daily ketoconazole, a strong CYP3A, P-gp and BCRP inhibitor, for 7 days in 11 previously treated patients with NHL increased venetoclax Cmax by 2.3-fold and AUC∞ by 6.4-fold.
Istodobna primjena ketokonazola, snažnog inhibitora CYP3A, P-gp-a i BCRP-a, u dozi od 400 mg jedanput na dan tijekom 7 dana u 11 prethodno liječenih bolesnika s NHL-om povećala je Cmax venetoklaksa 2,3 puta, a AUC∞ 6,4 puta.
Grade ≥3a
≥ 3. stupnjaa
The ORR for patients with 17p deletion and/or TP53 mutation was 72% (33/46) (95% CI: 56.5, 84.0) in Arm A and 67% (8/12) (95% CI: 34.9, 90.1) in Arm B. For patients without 17p deletion and/or TP53 mutation, the ORR was 69% (31/45) (95% CI: 53.4, 81.8) in Arm A and 71% (17/24) (95% CI: 48.9, 87.4) in Arm B.
Za bolesnike s delecijom 17p i/ili mutacijom gena TP53, ORR je iznosio 72% (33/46) (95% CI: 56,5; 84,0) u skupini A i 67% (8/12) (95% CI: 34,9; 90,1) u skupini B.
Dose interruptions or reductions are recommended for patients with severe neutropenia (see section 4.2).
U bolesnika s teškom neutropenijom preporučuje se privremeni prekid primjene ili smanjenje doze (vidjeti dio 4.2).
What Venclyxto is used for
Za što se Venclyxto koristi
Dose modifications for tumour lysis syndrome
Prilagodbe doze kod sindroma lize tumora
• muscle pain or uncomfortable joints
• neobičan umor • bol u mišićima ili nelagodu u zglobovima
Keep this medicine out of the sight and reach of children.
Kako čuvati Venclyxto Lijek čuvajte izvan pogleda i dohvata djece.
Pale yellow, oblong biconvex shaped tablet 17.2 mm long, 9.5 mm wide debossed with V on one side and 100 on the other.
Blijedožuta, ovalna, bikonveksna tableta duljine 17,2 mm i širine 9,5 mm, s utisnutom oznakom 'V' na jednoj strani i '100' na drugoj strani.
• 7 tablets (7 blisters each with 1 tablet)
• 7 tableta (7 blistera, svaki s 1 tabletom)
PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON Multipack (with blue box)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - višestruko pakiranje (uključujući plavi okvir)
In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.
Najčešće nuspojave u ispitivanjima monoterapije bile su neutropenija/smanjen broj neutrofila, proljev, mučnina,
• 14 tablets (7 blisters each with 2 tablets)
• 14 tableta (7 blistera, svaki s 2 tablete)
Coadministration of 50 mg once daily ritonavir, a strong CYP3A and P-gp inhibitor, for 14 days in 6 healthy subjects increased venetoclax Cmax by 2.4-fold and AUC by 7.9-fold.
Istodobna primjena ritonavira, snažnog inhibitora CYP3A i P-gp-a, u dozi od 50 mg jedanput na dan tijekom 14 dana u 6 zdravih ispitanika povećala je Cmax venetoklaksa 2,4 puta, a AUC 7,9 puta.
You should start drinking at least 1.5 to 2 litres of water daily two days before starting Venclyxto.
Trebate početi piti najmanje 1,5 - 2 litre vode na dan dva dana prije nego što počnete uzimati
Post-titration dose for venetoclax monotherapy
Doza venetoklaksa u monoterapiji nakon titracije
Return to your normal dose schedule the next day.
Nastavite s primjenom sutradan prema uobičajenom rasporedu.
Concomitant use of venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities (see section 4.4).
Treba izbjegavati istodobnu primjenu venetoklaksa s inhibitorima P-gp-a i BCRP-a pri uvođenju liječenja i tijekom faze titracije doze; ako se inhibitor P-gp-a i BCRP-a mora primijeniti,
In a drug-drug interaction study in three healthy volunteers, administration of a single dose of 400 mg venetoclax with 5 mg warfarin resulted in an 18% to 28% increase in Cmax and AUC∞ of R-warfarin and S-warfarin.
U ispitivanju interakcija s drugim lijekovima, provedenom u tri zdrava dobrovoljca, primjena jednokratne doze venetoklaksa od 400 mg zajedno s 5 mg varfarina povećala je Cmax i AUC∞
Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets
Venclyxto 10 mg filmom obložene tablete Venclyxto 50 mg filmom obložene tablete Venclyxto 100 mg filmom obložene tablete
Package leaflet: Information for the patient Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets venetoclax This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika Venclyxto 10 mg filmom obložene tablete Venclyxto 50 mg filmom obložene tablete Venclyxto 100 mg filmom obložene tablete venetoklaks
The film-coated tablets are supplied in cartons containing either 10 or 14 tablets (in blisters of 2 tablets).
Venclyxto 10 mg tablete Filmom obložene tablete dolaze u kutijama koje sadrže 10 ili 14 tableta (u blisterima s 2 tablete).
AbbVie Kft. Tel:+36 1 455 8600
Tel:+36 1 455 8600
- medicines for fungal infections - fluconazole, itraconazole, ketoconazole, posaconazole, or voriconazole - antibiotics to treat bacterial infections - ciprofloxacin, clarithromycin, erythromycin, nafcillin, or rifampicin - medicines to prevent seizures or to treat epilepsy - carbamazepine, phenytoin - medicines for HIV infection - efavirenz, etravirine, ritonavir - medicines to treat raised blood pressure or angina - diltiazem, verapamil - medicines to lower cholesterol levels in the blood - cholestyramine, colestipol, colesevelam - a medicine used to treat a lung condition called pulmonary arterial hypertension - bosentan - a medicine to treat sleep disorder (narcolepsy) known as modafinil - a herbal medicine known as St. John's wort
- lijekove za gljivične infekcije - flukonazol, itrakonazol, ketokonazol, posakonazol ili vorikonazol - antibiotike koji se koriste za liječenje bakterijskih infekcija - ciprofloksacin, klaritromicin,
Urinary tract infection Upper respiratory tract infection
anemija, umor i infekcija gornjih dišnih putova.
• fits or seizures
• mučnina ili povraćanje
• 10 tablets (5 blisters each with 2 tablets)
• 10 tableta (5 blistera, svaki s 2 tablete)
Venclyxto 100 mg film-coated tablets 3 years.
Venclyxto 100 mg filmom obložene tablete 3 godine.
The median time on treatment at the time of evaluation was 12 months (range: 0 to 22 months).
Medijan trajanja liječenja u trenutku ocjenjivanja iznosio je 12 mjeseci (raspon:
OS = overall survival; PFS = progression-free survival, PR = partial remission, TTR = time to first response.
ND = nije dostupno; NP = nije postignuto; ORR = stopa ukupnog odgovora; PFS = preživljenje bez progresije bolesti; PR = djelomična remisija; TTR (engl. time to first response) = vrijeme do prvog odgovora.
Film-coated tablet 14 film-coated tablets
Filmom obložena tableta 14 filmom obloženih tableta
• the dose will be increased to 50 mg (one 50 mg tablet) once a day for 7 days.
• doza će se povećati na 50 mg (jedna tableta od 50 mg) jedanput na dan tijekom 7 dana
What Venclyxto is and what it is used for 2.
Što je Venclyxto i za što se koristi
Concomitant use of this medicinal product with strong or moderate CYP3A inhibitors increases venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase (see sections 4.2 and 4.3).
Istodobna primjena ovog lijeka sa snažnim ili umjerenim inhibitorima CYP3A povećava izloženost venetoklaksu i može povećati rizik od TLS-a pri uvođenju liječenja i tijekom faze titracije doze
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax (see section 4.5).
Tijekom liječenja venetoklaksom treba izbjegavati proizvode od grejpa, gorke naranče (sorta Seville) i zvjezdasto voće (karambolu).
Prevention of tumour lysis syndrome (TLS)
Prevencija sindroma lize tumora (engl.
Film-coated tablet 7 film-coated tablets
Filmom obložena tableta 7 filmom obloženih tableta
Blood creatinine increased aOnly the highest frequency observed in the trials is reported (based on studies MURANO, M13-982, M14032, and M12-175).
MURANO, M13-982, M14-032 i M12-175).
Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other.
Bež, ovalna, bikonveksna tableta duljine 14 mm i širine 8 mm, s utisnutom oznakom 'V' na jednoj strani i '50' na drugoj strani.
The film-coated tablets are supplied in cartons containing either 5 or 7 tablets(in blisters of 1 tablet).
Venclyxto 50 mg tablete Filmom obložene tablete dolaze u kutijama koje sadrže 5 ili 7 tableta (u blisterima s 1 tabletom).
• the dose will be increased to 400 mg (four 100 mg tablets) once a day for 7 days.
• doza će se povećati na 400 mg (četiri tablete od 100 mg) jedanput na dan tijekom 7 dana.
Discontinuation and dose reductions due to adverse reactions Discontinuations due to adverse reactions occurred in 16% of patients treated with the combination of venetoclax and rituximab in the MURANO study.
Do prekida liječenja zbog nuspojava došlo je u 16% bolesnika liječenih kombinacijom venetoklaksa i rituksimaba u ispitivanju MURANO.
CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery, nPR = nodular PR; NR = not reached, ORR = overall response rate;.
CI = interval pouzdanosti; CR = potpuna remisija; CRi = potpuna remisija uz nepotpun oporavak koštane srži; IRC = neovisno ocjenjivačko povjerenstvo; nPR = nodularna djelomična remisija;
Film-coated tablet 10 film-coated tablets
Filmom obložena tableta 10 filmom obloženih tableta
Venclyxto 100 mg film-coated tablet is pale yellow, oblong 17.2 mm long with V on one side and 100 on the other.
Venclyxto 100 mg filmom obložena tableta je blijedožuta, ovalna tableta duljine 17,2 mm, s oznakom 'V' na jednoj strani i '100' na drugoj strani.
Venclyxto 100 mg tablets
Venclyxto 100 mg tablete
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Venclyxto je u kombinaciji s rituksimabom indiciran za liječenje kronične limfocitne leukemije (KLL)
Tumour lysis syndrome (common - may affect up to 1 in 10 people) Stop taking Venclyxto and seek medical attention immediately if you notice any of the symptoms of TLS:
Prestanite uzimati Venclyxto i odmah potražite liječničku pomoć ako primijetite bilo koji od simptoma
CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery, DOR = duration of response; IRC = independent review committee; nPR = nodular PR; NA = not available; NR = not reached; ORR = overall response rate; PFS = progression-free survival, PR = partial remission; TTR = time to first response.
(n=48) CI = interval pouzdanosti; CR = potpuna remisija; CRi = potpuna remisija uz nepotpun oporavak koštane srži; nPR = nodularna djelomična remisija; NP = nije postignuto; ORR = stopa ukupnog odgovora; OS (engl. overall survival) = ukupno preživljenje; PFS = preživljenje bez progresije bolesti; PR = djelomična remisija; TTR = vrijeme do prvog odgovora.
Venclyxto 50 mg film-coated tablets 2 years.
Venclyxto 50 mg filmom obložene tablete 2 godine.
Each film-coated tablet contains 100 mg venetoclax
Jedna filmom obložena tableta sadrži 100 mg venetoklaksa
Each film-coated tablet contains 50 mg venetoclax
Jedna filmom obložena tableta sadrži 50 mg venetoklaksa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• lijekove za snižavanje razine kolesterola u krvi koji se zovu statini Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koje ste nabavili bez recepta te biljne lijekove i dodatke prehrani.
Venclyxto 50 mg film-coated tablet is beige, oblong 14 mm long, with V on one side and 50 on the other.
Venclyxto 50 mg filmom obložena tableta je bež, ovalna tableta duljine 14 mm, s oznakom 'V' na jednoj strani i '50' na drugoj strani.
Hydration
Hidracija
Each film-coated tablet contains 10 mg venetoclax
Jedna filmom obložena tableta sadrži 10 mg venetoklaksa
The cut-off for a negative status was one CLL cell per 104 leukocytes.
KLL-a na 104 leukocita.
The efficacy data were further evaluated by an IRC demonstrating a combined ORR of 70% (Arm A: 70%;
Podatke o djelotvornosti dodatno je ocijenio IRC, pri čemu je utvrđen objedinjen ORR od
Venclyxto 10 mg film-coated tablets 2 years.
Venclyxto 10 mg filmom obložene tablete 2 godine.
Twenty-seven percent (42/158) of patients were MRD negative in the peripheral blood, including 16 patients who were also MRD negative in the bone marrow.
Dvadeset i sedam posto bolesnika (42/158) imalo je negativan nalaz na MRD
Venclyxto 10 mg film-coated tablet is pale yellow, round 6 mm diameter, with V on one side and 10 on the other.
Venclyxto 10 mg filmom obložena tableta je blijedožuta, okrugla tableta promjera 6 mm, s oznakom 'V' na jednoj strani i '10' na drugoj strani.
Film-coated tablet 5 film-coated tablets
Filmom obložena tableta 5 filmom obloženih tableta
Iron oxide yellow (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b)
Film ovojnica željezov oksid, žuti (E172) poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol 3350 (E1521) talk (E553b)
• the dose will be increased to 200 mg (two 100 mg tablets) once a day for 7 days.
• doza će se povećati na 200 mg (dvije tablete od 100 mg) jedanput na dan tijekom 7 dana
Tel: + 385 (0)1 5625 501
AbbVie d.o.o. Tel: + 385 (0)1 5625 501
ORR, % (95% CI)
PFS, % (95% CI)
Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with venetoclax.
U bolesnika s prethodno liječenim KLL-om i velikim opterećenjem tumorskom masom, pri liječenju venetoklaksom zabilježen je sindrom lize tumora, uključujući slučajeve sa smrtnim ishodom.
In vitro studies indicated that venetoclax is not an inhibitor or inducer of CYP1A2, CYP2B6, CYP2C19, CYP2D6 or CYP3A4 at clinically relevant concentrations.
CYP2C19, CYP2D6 ni CYP3A4 pri klinički značajnim koncentracijama.
• severe infection in the blood (sepsis)
Česte (mogu se javiti u do 1 na 10 osoba) • teška infekcija u krvi (sepsa)
Low white blood cell count (neutropenia) (very common - may affect more than 1 in 10 people) Your doctor will check your blood count during treatment with Venclyxto.
Nizak broj bijelih krvnih stanica (neutropenija) (vrlo često - može se javiti u više od 1 na
In the MURANO study, neutropenia was reported in 61% (all grades) of patients on the venetoclax + rituximab arm. Forty-three percent of patients treated with venetoclax + rituximab experienced dose interruption and 3% of patients discontinued venetoclax due to neutropenia.
Primjena je privremeno prekinuta u 43% bolesnika liječenih venetoklaksom + rituksimabom, dok je liječenje venetoklaksom zbog neutropenije trajno prekinulo 3% bolesnika.
• higher level of potassium
• povišene vrijednosti kalija
Name and address of the manufacturer(s) responsible for batch release AbbVie Deutschland GmbH & Co. KG Knollstrasse
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet AbbVie
• Venclyxto 50 mg film-coated tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b)
• Venclyxto 50 mg filmom obložene tablete: žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172), poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 3350 (E1521), talk (E553b).
• the dose will be increased to 100 mg (one 100 mg tablet) once a day for 7 days.
• doza će se povećati na 100 mg (jedna tableta od 100 mg) jedanput na dan tijekom 7 dana
• Venclyxto 100 mg film-coated tablets: Each film-coated tablet contains 100 mg venetoclax.
• Venclyxto 100 mg filmom obložene tablete: jedna filmom obložena tableta sadrži 100 mg venetoklaksa.
• Venclyxto 50 mg film-coated tablets: Each film-coated tablet contains 50 mg venetoclax.
• Venclyxto 50 mg filmom obložene tablete: jedna filmom obložena tableta sadrži 50 mg venetoklaksa.
dOf those with MRD assay results available in bone marrow, 76.9% (30/39) in the venetoclax + rituximab arm and 6.7% (2/30) in the bendamustine + rituximab arm were found to be MRD negative.
bolesnika u skupini liječenoj venetoklaksom + rituksimabom i 6,7% (2/30) bolesnika koji su primali bendamustin
Venclyxto 50 mg tablets venetoclax
Venclyxto 50 mg tablete venetoklaks
• Venclyxto 100 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
• Venclyxto 100 mg filmom obložene tablete: žuti željezov oksid (E172), poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 3350 (E1521), talk (E553b).
Venclyxto 50 mg film-coated tablets Each film-coated tablet contains 50 mg of venetoclax.
Venclyxto 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg venetoklaksa.
• Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg venetoclax.
• Venclyxto 10 mg filmom obložene tablete: jedna filmom obložena tableta sadrži 10 mg venetoklaksa.
LIST OF EXCIPIENTS
Ocjena ispitivača
• Venclyxto 10 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
• Venclyxto 10 mg filmom obložene tablete: žuti željezov oksid (E172), poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 3350 (E1521), talk (E553b).
The safety and efficacy of venetoclax in 107 patients with previously treated CLL with 17p deletion were evaluated in a single arm, open-label, multi-center study (M13-982).
17p ocjenjivale su se u otvorenom, multicentričnom ispitivanju s jednom skupinom (M13-982).
Gastric acid reducing agents
Lijekovi koji smanjuju želučanu kiselinu
Venclyxto 100 mg film-coated tablets Each film-coated tablet contains 100 mg of venetoclax.
Venclyxto 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg venetoklaksa.
Venclyxto 100 mg film-coated tablets:
Venclyxto 100 mg filmom obložene tablete:
Venclyxto 50 mg film-coated tablets:
Venclyxto 50 mg filmom obložene tablete:
The estimated PFS rate at 6 months post treatment was 92%.
Procijenjena stopa PFS-a 6 mjeseci nakon liječenja iznosila je
Venclyxto 10 mg film-coated tablets Each film-coated tablet contains 10 mg of venetoclax.
Venclyxto 10 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 10 mg venetoklaksa.
Venclyxto 10 mg film-coated tablets:
Venclyxto 10 mg filmom obložene tablete:
Venclyxto 10 mg tablets venetoclax
Venclyxto 10 mg tablete venetoklaks
Venclyxto 100 mg film-coated tablet
Venclyxto 100 mg filmom obložena tableta
Constipation
Cijepljenje
Colloidal anhydrous silica (E551) Polysorbate 80 (E433)
Jezgra tablete kopovidon (K 28) silicijev dioksid, koloidni, bezvodni (E551) polisorbat 80 (E433) natrijev stearilfumarat kalcijev hidrogenfosfat, bezvodni (E341 (ii))
Venclyxto 10 mg film-coated tablets
Venclyxto 10 mg filmom obložena tableta
Venclyxto 10 mg film-coated tablets venetoclax
Venclyxto 10 mg filmom obložene tablete venetoklaks
• constipation
• smetenost
Venclyxto 100 mg tablets venetoclax
Venclyxto 100 mg tablete venetoklaks
Venclyxto 50 mg film-coated tablets
Venclyxto 50 mg filmom obložena tableta
Hepatic impairment
Progresija bolesti
Venclyxto 100 mg film-coated tablets venetoclax
Venclyxto 100 mg filmom obložene tablete venetoklaks
If a patient misses a dose of venetoclax within 8 hours of the time it is usually taken, the patient should take the missed dose as soon as possible on the same day.
8 sati, treba uzeti propuštenu dozu što je prije moguće istoga dana.
Venclyxto 50 mg film-coated tablets venetoclax
Venclyxto 50 mg filmom obložene tablete venetoklaks
• diarrhoea
• nedostatak zraka
EXPIRY DATE
Završni datum prikupljanja podataka
Ltd
KG
At baseline, 46.6% of patients had one or more nodes ≥5 cm, and
Na početku je ispitivanja 46,6% bolesnika imalo jedan ili više čvorova ≥ 5 cm, dok ih je 67,6% imalo apsolutni broj limfocita ≥ 25 x 109/l.
Tumour lysis syndrome Hyperuricaemia
Opis odabranih nuspojava Sindrom lize tumora
• higher level of urea
• povišene vrijednosti ureje
Eighteen patients in the venetoclax + rituximab arm and 3 patients in the bendamustine + rituximab arm had negative bone marrow and lymph nodes <2 cm. bMinimal residual disease was evaluated using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry.
bMinimalna rezidualna bolest (MRD) ocjenjivala se lančanom reakcijom polimerazom uz primjenu oligonukleotida specifičnih za alel (engl. allele-specific oligonucleotide polymerase chain reaction,
Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171)
Film ovojnica željezov oksid, žuti (E172) željezov oksid, crveni (E172) željezov oksid, crni (E172) poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol 3350 (E1521) talk (E553b)
8 (8 x 1) vials
8 ( 8 x 1 ) bočica
[The below wording should replace the previous wording] Titration on a weekly basis is recommended in case higher doses are required.
[Prethodni tekst mora se zamijeniti sljedećim tekstom] U slučaju da su potrebne više doze preporučuje se tjedna titracija.
Note: These amendments are to be incorporated to the valid summary of product characteristics, labelling and package leaflet which are the final versions achieved during the Coordination group procedure.
Napomena: Ove izmjene potrebno je unijeti u važeći sažetak opisa svojstava lijeka, označavanje i uputu o lijeku koji su konačne verzije postignute tijekom postupka Koordinacijske skupine.
Some patients may benefit from higher daily doses up to a maximum of 60 mg/30 mg oxycodone.
Nekim bolesnicima mogu koristiti više dnevne doze do najviše 60 mg/30 mg oksikodona.
The mean daily dose in the pivotal study was 20mg/10mg oxycodone hydrochloride/naloxone hydrochloride.
Srednja vrijednost dnevne doze u glavnom ispitivanju bila je 20 mg/10 mg oksikodonklorida/naloksonklorida.
Annex III Amendments to the summary of product characteristics
Dodatak III Izmjene sažetka opisa svojstava lijeka
• Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
• Bioekvivalencija u odnosu na referentni lijek odobren u EU-u dokazana je na temelju relevantnih podataka, sukladno zahtjevima iz članka 10.
For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holder(s)
Kako bi se ukinula privremena obustava odobrenja za stavljanje lijeka u promet iz Priloga I.B, nadležna će tijela osigurati da je nositelj odobrenja za stavljanje lijeka u promet ispunio sljedeće uvjete:
24 months.
24 mjeseci.
Date of first authorisation: 5 September 2017
Datum prvog odobrenja: 5. rujna 2017.
This medicine has been prescribed for you only.
Ovaj je lijek propisan samo vama.
These findings were not reversible.
Ti nalazi nisu bili reverzibilni.
Do not stop your treatment without the advice of your doctor even if you feel better because Wilson's disease is a life-long condition.
Nemojte prekidati liječenje bez savjeta liječnika, čak i ako se osjećate bolje jer Wilsonova bolest traje cijeli život.
Not known (frequency cannot be estimated from available data)
Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka)
This leaflet was last revised in.
Ova uputa zadnji je put revidirana u
Your symptoms may initially get worse after starting the treatment.
Vaši se simptomi prvo mogu pogoršati nakon početka liječenja.
EU/1/17/1199/001 72 film-coated tablets EU/1/17/1199/002 96 film-coated tablets
EU/1/17/1199/001 72 filmom obložene tablete EU/1/17/1199/002 96 filmom obloženih tableta
Do not throw away any medicines via wastewater or household waste.
Nikada nemojte lijekove bacati u otpadne vode niti u kućni otpad.