natgillin/translations-raw huggingface dataset:
The proportion of subjects requiring treatment for a gout flare (APEX and FACT Study) was numerically lower in the groups that achieved an average post-baseline serum urate level <6.0 mg/dL, <5.0 mg/dL, or <4.0 mg/dL compared to the group that achieved an average post-baseline serum urate level ≥6.0 mg/dL during the last 32 weeks of the treatment period (Week 20-Week 24 to Week 49 - 52 intervals). 
Udio bolesnika kojima je bilo potrebno liječenje akutnog napada gihta (ispitivanja APEX i FACT) bio je brojčano manji u skupinama kod kojih je nakon početka liječenja postignuta prosječna razina urata u serumu <6,0 mg/dl, <5,0 mg/dl, ili <4,0 mg/dl, u usporedbi sa skupinom kod koje je nakon početka liječenja postignuta prosječna razina urata u serumu ≥6,0 mg/dl tijekom posljednja 32 tjedna liječenja
EU/1/08/447/016 EU/1/08/447/017 EU/1/08/447/018 
EU/1/08/447/013 EU/1/08/447/014 EU/1/08/447/015 EU/1/08/447/016 EU/1/08/447/017 EU/1/08/447/018
Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro. 
Desipramin/supstrati CYP2D6 Pokazalo se da je febuksostat slab inhibitor CYP2D6 in vitro.
See the package leaflet for further information. 
Za daljnje informacije vidjeti uputu o lijeku.
Three years data showed a decrease in the incidence of gout flares with less than 4% of patients requiring treatment for a flare (i.e. more than 96% of patients did not require treatment for a flare) at Month 16-24 and at Month 30-36. 
4% bolesnika kojima je bilo potrebno liječenje akutnog napada gihta (tj. kod više od 96% bolesnika nije bilo potrebno liječenje akutnih napada gihta) od 16. do 24. i od 30. do 36. mjeseca ispitivanja.
Rare reports of serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience. 
Alergija/preosjetljivost na lijek Nakon stavljanja lijeka u promet su prikupljene rijetke prijave ozbiljnih alergijskih reakcija/reakcija preosjetljivosti, uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu i akutnu anafilaktičku reakciju/šok.
ADENURIC 80 mg and 120 mg is available in packs containing 14, 28, 42, 56, 84 and 98 film-coated tablets. 
ADENURIC 80 mg i 120 mg dostupni su pakiranjima od 14, 28, 42, 56, 84 i 98 filmom obloženih tableta.
EU/1/08/447/001 28 film-coated tablets EU/1/08/447/002 84 film-coated tablets EU/1/08/447/005 14 film-coated tablets EU/1/08/447/006 42 film-coated tablets EU/1/08/447/007 56 film-coated tablets EU/1/08/447/008 98 film-coated tablets EU/1/08/447/013 14 film-coated tablets EU/1/08/447/014 28 film-coated tablets EU/1/08/447/015 42 film-coated tablets EU/1/08/447/016 56 film-coated tablets EU/1/08/447/017 84 film-coated tablets EU/1/08/447/018 98 film-coated tablets 
EU/1/08/447/001 28 filmom obloženih tableta EU/1/08/447/002 84 filmom obložene tablete EU/1/08/447/005 14 filmom obloženih tableta EU/1/08/447/006 42 filmom obložene tablete EU/1/08/447/007 56 filmom obloženih tableta EU/1/08/447/008 98 filmom obloženih tableta EU/1/08/447/013 14 filmom obloženih tableta EU/1/08/447/014 28 filmom obloženih tableta EU/1/08/447/015 42 filmom obložene tablete EU/1/08/447/016 56 filmom obloženih tableta EU/1/08/447/017 84 filmom obložene tablete EU/1/08/447/018 98 filmom obloženih tableta
Mean AUC sUA1-8 (mgxh/dl) was significantly lower with ADENURIC (514.0 ± 225.71 vs 708.0 ± 234.42; least square means difference: -196.794 [95% confidence interval: -238.600 ; -154.988]; p < .0001). 
sMK1-8 (mgxh/dl) bila je značajno niža s ADENURICOM (514,0 ± 225,71 naspram 708,0 ± 234,42;
• hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (hemorrhage, seen only in patients taking chemotherapy for blood disorders) 
• navale vrućine ili navale crvenila (npr. crvenilo lica ili vrata), povišen krvni tlak, krvarenje
Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis Rare 
Artralgija, artritis, mialgija, bolovi u mišićima i kostima, slabost mišića, grčevi u mišićima, napetost mišića, burzitis
EU/1/08/447/001 EU/1/08/447/002 EU/1/08/447/005 EU/1/08/447/006 EU/1/08/447/007 EU/1/08/447/008 EU/1/08/447/013 EU/1/08/447/014 EU/1/08/447/015 
EU/1/08/447/001 EU/1/08/447/002 EU/1/08/447/005 EU/1/08/447/006 EU/1/08/447/007 EU/1/08/447/008
EU/1/08/447/003 28 film-coated tablets EU/1/08/447/004 84 film-coated tablets EU/1/08/447/009 14 film-coated tablets EU/1/08/447/010 42 film-coated tablets EU/1/08/447/011 56 film-coated tablets EU/1/08/447/012 98 film-coated tablets EU/1/08/447/019 14 film-coated tablets EU/1/08/447/020 28 film-coated tablets EU/1/08/447/021 42 film-coated tablets EU/1/08/447/022 56 film-coated tablets EU/1/08/447/023 84 film-coated tablets EU/1/08/447/024 98 film-coated tablets 
EU/1/08/447/003 28 filmom obloženih tableta EU/1/08/447/004 84 filmom obložene tablete EU/1/08/447/009 14 filmom obloženih tableta EU/1/08/447/010 42 filmom obložene tablete EU/1/08/447/011 56 filmom obloženih tableta EU/1/08/447/012 98 filmom obloženih tableta EU/1/08/447/019 14 filmom obloženih tableta EU/1/08/447/020 28 filmom obloženih tableta EU/1/08/447/021 42 filmom obložene tablete EU/1/08/447/022 56 filmom obloženih tableta EU/1/08/447/023 84 filmom obložene tablete EU/1/08/447/024 98 filmom obloženih tableta
APPROPRIATE 11. 
PRILOG II.
The APEX study showed statistically significant superiority of both the ADENURIC 80 mg QD and the ADENURIC 120 mg QD treatment arms versus the conventionally used doses of allopurinol 300 mg (n = 258) /100 mg (n = 10) treatment arm in reducing the sUA below 6 mg/dL (357 µmol/L) (see Table 2 and Figure 1). 
Ispitivanje APEX pokazalo je statistički značajnu superiornost liječenja, kako ADENURICOM 80 mg jednom dnevno tako i ADENURICOM 120 mg jednom dnevno u odnosu na liječenje uobičajeno korištenim dozama alopurinola 300 mg (n = 258)/100 mg (n = 10), s obzirom na snižavanje razine mokraćne kiseline u serumu ispod 6 mg/dl (357 µmol/l) (vidjeti tablicu 2 i sliku 1).
Rash (including various types of rash reported with lower frequencies, see below) 
Često Osip (uključujući razne tipove osipa s manjom učestalošću,
ADENURIC is available as either an 80 mg tablet or a 120 mg tablet. 
Dostupne su tablete ADENURICA od 80 mg i 120 mg.
Severe hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) were associated with fever, haematological, renal or hepatic involvement in some cases. 
Teške reakcije preosjetljivosti, uključujući reakciju na lijek s eozinofilijom i sustavnim simptomima (Drug Reaction with Eosinophilia and Systemic Symptoms,
6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively. 
Udio bolesnika koji su postigli primarni ishod djelotvornosti (razina mokraćne kiseline u serumu <6,0 mg/dl na završnoj kontroli) u CONFIRMS ispitivanju, a kojima je početna razina mokraćne kiseline u serumu bila ≥ 10 mg/dl bio je 27% (66/249) kod bolesnika liječenih febuksostatom od 40 mg jednom dnevno, 49% (125/254) kod liječenih febuksostatom od 80 mg jednom dnevno te 31% (72/230) kod bolesnika liječenih alopurinolom 300 mg/200 mg jednom dnevno.
Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated 
Jezgra tablete laktoza hidrat celuloza, mikrokristalična magnezijev stearat hidroksipropilceluloza karmelozanatrij, umrežena silicijev dioksid, koloidni, hidratizirani
The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C). 
Djelotvornost i sigurnost febuksostata nije ispitivana kod bolesnika s teškim oštećenjem funkcije jetre
Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting XO. Febuxostat is a potent, non-purine selective inhibitor of XO (NP-SIXO) with an in vitro inhibition Ki value less than one nanomolar. 
Febuksostat je derivat 2-ariltiazola koji postiže terapijski učinak smanjivanjem razine mokraćne kiseline u serumu selektivnim inhibiranjem XO.
If you stop taking ADENURIC your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys. 
Ako prestanete uzimati ADENURIC, razina mokraćne kiseline može početi rasti i simptomi
Fact study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for a gout flare compared to both the febuxostat 80 mg (22%) and allopurinol 300 mg (21%) treatment groups. 
FACT ispitivanje: Tijekom razdoblja provođenja profilakse u trajanju od 8 tjedana, zabilježen je veći udio ispitanika kojima je bilo potrebno liječenje akutnog napada gihta u skupini na febuksostatu 120 mg (36%), u odnosu na skupinu na febuksostatu 80 mg (22%) i alopurinolu 300 mg (21%).
Post Marketing long term studies 
Dugotrajna ispitivanja nakon stavljanja lijeka u promet
Seven hundred sixty (760) patients were randomized: ADENURIC 80 mg QD (n=256), ADENURIC 120 mg QD (n=251), or allopurinol 300 mg QD (n=253). 
bolesnika je randomizirano te su primali: ADENURIC 80 mg jednom dnevno (n = 256), ADENURIC 120 mg jednom dnevno (n = 251), ili alopurinol 300 mg jednom dnevno (n = 253).
It is not known if ADENURIC may harm your unborn child. ADENURIC should not be used during pregnancy. 
ADENURIC se ne smije uzimati tijekom trudnoće.
APEX Study: The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study. 
(APEX) bilo je randomizirano, dvostruko slijepo, multicentrično ispitivanje faze 3 u trajanju od 28 tjedana.
A total of 1,086 patients were enrolled: ADENURIC 80 mg QD (n=649), Adenuric 120 mg QD (n=292) and allopurinol 300/100 mg QD (n=145). 
dobivali su ADENURIC 80 mg jednom dnevno (n=649), ADENURIC 120 mg jednom dnevno (n=292) i alopurinol 300/100 mg jednom dnevno (n=145).
A. MANUFACTURE(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of ADENURIC, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk. 
(Stevens-Johnsonov sindrom), a koji počinje na koži trupa crvenkastim kožnim točkama poput mete ili okruglim mrljama često sa stvaranjem mjehura u sredini.
The FACT study showed the statistically significant superiority of both ADENURIC 80 mg and ADENURIC 120 mg QD treatment arms versus the conventionally used dose of allopurinol 300 mg treatment arm in reducing and maintaining sUA below 6 mg/dL (357 µmol/L). 
Ispitivanje FACT pokazalo je statistički značajnu superiornost liječenja, kako ADENURICOM 80 mg tako i ADENURICOM 120 mg jednom dnevno u odnosu na liječenje uobičajeno korištenim dozama alopurinola 300 mg, s obzirom na snižavanje razine mokraćne kiseline u serumu ispod 6 mg/dl (357
In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03;95% CI 0.871.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73). 
Cardiovascular Events, MACE) bila je slična u bolesnika liječenih febuksostatom i bolesnika liječenih alopurinolom (HR 1,03; 95% CI 0,87-1,23), ali je u bolesnika liječenih febuksostatom primijećena viša stopa kardiovaskularne smrti (4,3% u odnosu na 3,2% bolesnika; HR 1,34; 95% CI
Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg 
1, Avenue de la Gare, L-1611 Luxembourg Luksemburg
Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy 
Prevencija i liječenje visokih razina mokraćne kiseline kod bolesnika koji su podvrgnuti kemoterapiji za rak Dostupne su tablete ADENURICA od 120 mg.
Opadry II, Yellow, 85F42129 containing: Polyvinyl alcohol 
Opadry II, Yellow, 85F42129 sadrži: poli(vinilni alkohol) titanijev dioksid (E171) makrogol 3350 talk željezov oksid, žuti (E172)
Thus, co-administration of febuxostat with rosiglitazone or other CYP2C8 substrates is not expected to require any dose adjustment for those compounds. 
Prema tome, nije očekivano da će istodobna primjena febuksostata s roziglitazonom ili drugim CYP2C8
• blood in the urine, abnormal frequent urination, abnormal urine tests (increased level of proteins in the urine), a reduction in the ability of the kidneys to function properly 
• krv u mokraći, učestalo mokrenje, abnormalni nalazi mokraće (povećana razina proteina u mokraći), smanjenje bubrežne funkcije • umor, bol u prsnom košu, osjećaj nelagode u prsnom košu
ADENURIC 120 mg film-coated tablets Febuxostat 
ADENURIC 120 mg filmom obložene tablete febuksostat
ADENURIC 80 mg film-coated tablets Febuxostat 
ADENURIC 80 mg filmom obložene tablete febuksostat
5 How to store ADENURIC Contents of the pack and other information 
Sadržaj pakiranja i druge informacije
ADENURIC 120 mg tablets Febuxostat 
NAZIV LIJEKA ADENURIC 120 mg tablete febuksostat
Over time, gout flares will occur less often and be less painful if you keep taking ADENURIC every day. 
S vremenom će se, ako nastavite uzimati ADENURIC svaki dan, napadaji gihta pojavljivati rjeđe i biti manje bolni.
Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine as inhibition of xanthine oxidase by febuxostat may cause increased plasma concentrations of mercaptopurine/azathioprine that could result in severe toxicity. 
azatioprinom , jer inhibicija ksantin oksidaze febuksostatom može uzrokovati povišene koncentracije merkaptopurina/azatioprina u plazmi, što može rezultirati teškom toksičnošću.
ADENURIC 80 mg tablets Febuxostat 
NAZIV LIJEKA ADENURIC 80 mg tablete febuksostat
Menarini International O. L. S.A. 
Nositelj odobrenja za stavljanje lijeka u promet: Menarini International O. L. S.A.
Possible symptoms of allergic reactions might be: - rash including severe forms (e.g. blisters, nodules, itchy-, exfoliative rash), itchiness - swelling of limbs or face - difficulties in breathing - fever with enlarged lymph nodes - but also serious life threatening allergic conditions with cardiac and circulatory arrest. 
Mogući simptomi alergijskih reakcija su: - osip uključujući i teške oblike (npr. mjehurići, kožni čvorići, eksfolijativni osip sa svrbežom),
Pharmacokinetic modelling and simulation of rat data suggests that, when co-administered with febuxostat, the clinical dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.4 and 4.5). 
Farmakokinetičko modeliranje i simulacija podataka na štakorima ukazuju da je, kad se istodobno primjenjuju s febuksostatom, kliničku dozu merkaptopurina/azatioprina potrebno smanjiti na 20% ili manje od prethodno propisane doze kako bi se izbjegli mogući hematološki učinci (vidjeti dijelove
Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the post-marketing experience. 
uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu i anafilaktičku reakciju/šok.
• cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis 
• kašalj, nedostatak daha, nelagoda ili bolovi u prsnom košu, upala nosne sluznice i/ili grla
In healthy subjects, maximum plasma concentrations (Cmax) and area under the plasma concentration time curve (AUC) of febuxostat increased in a dose proportional manner following single and multiple doses of 10 mg to 120 mg. For doses between 120 mg and 300 mg, a greater than dose proportional increase in AUC is observed for febuxostat. 
febuksostata povećavali su se proporcionalno dozi nakon jednokratnih i ponovljenih doza od 10 mg do 120 mg.
• potentially life-threatening skin rashes characterised by formation of blisters and shedding of the skin and inner surfaces of body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (Stevens- Johnson Syndrome/ Toxic Epidermal Necrolysis), or by enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (drug reaction with eosinophilia and systemic symptoms-DRESS) (see section 2) 
ADENURICOM) • kožni osipi koji mogu biti opasni po život, karakterizirani stvaranjem mjehura, ljuštenjem kože i sluznica, npr. usta i genitalija, bolnim čirevima u ustima i/ili na području genitalija, udruženim s vrućicom, grloboljom i umorom (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza)
FACT Study: The Febuxostat Allopurinol Controlled Trial (FACT) Study was a Phase 3, randomized, double-blind, multicenter, 52-week study. 
Ispitivanje FACT: Kontrolirano ispitivanje febuksostata i alopurinola (FACT) je bilo randomizirano,
Blood glucose increased, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine. 
Povišena glukoza u krvi, produljeno aktivirano parcijalno tromboplastinsko vrijeme, smanjen broj crvenih krvnih stanica, povišena alkalna fosfataza u krvi, povišena kreatin fosfokinaza u krvi* * Nuspojave prijavljene nakon stavljanja lijeka u promet
Week 
tjedna).
The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience in gout patients are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema. 
Najčešće prijavljivane nuspojave u kliničkim ispitivanjima (4072 ispitanika primila su barem jednu dozu od 10 mg do 300 mg) i nakon stavljanja lijeka u promet kod bolesnika s gihtom su napadi gihta,
ADENURIC tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body. 
ADENURIC tablete sadrže djelatnu tvar febuksostat i koriste se za liječenje uloga (gihta),
Febuxostat 
Doziranje
Vascular disorders: Uncommon: haemorrhage 
Krvožilni poremećaji: Manje često: krvarenje
APEX study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for gout flare compared to febuxostat 80 mg (28%), allopurinol 300 mg (23%) and placebo (20%). 
mg (36%), u odnosu na skupinu na febuksostatu 80 mg (28%), alopurinolu 300 mg (23%) i placebu (20%).
Package leaflet: Information for the user ADENURIC 80 mg film-coated tablets ADENURIC 120 mg film-coated tablets 
ADENURIC 80 mg filmom obložene tablete ADENURIC 120 mg filmom obložene tablete febuksostat
Each tablet contains 120 mg febuxostat. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 120 mg febuksostata.
Each tablet contains 80 mg febuxostat. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 80 mg febuksostata.
Age 
N
Following an 80 mg oral dose of 14C 
Nakon višekratnih peroralno primijenjenih doza od 80 mg jednom dnevno ili jednokratne doze od
ADENURIC 80 mg film-coated tablets 
NAZIV LIJEKA ADENURIC 80 mg filmom obložene tablete
ADENURIC 120 mg film-coated tablets 
NAZIV LIJEKA ADENURIC 120 mg filmom obložene tablete
Contents of the pack and other information What ADENURIC contains 
Što ADENURIC sadrži
Gout flares 
MENARINI HELLAS AE
Parenteral nutrition is essential in certain situations, and there are various methods available for preparation and delivery. 
Parenteralna prehrana je ključna u određenim situacijama te su dostupne različite metode za pripremu i isporuku.
Numeta has been registered through the decentralised procedure (DCP) in Europe in 18 countries. 
Numeta je odobrena decentraliziranim postupkom (DCP) u 18 država EU-a.
A DHPC was agreed, together with the timelines for distribution; 
DHPC se također složio o rasporedima distribucije;
Overall conclusion and conditions to the Marketing Authorisations 
Ukupni zaključci i uvjeti odobrenja za stavljanje lijeka u promet
• The PRAC also concluded that there was need for further risk minimisation measures such as information to healthcare professionals. 
• je PRAC također zaključio da je postojala potreba za daljnjim mjerama minimizacije rizika poput informacija za zdravstvene djelatnike.
1 Canadian Laboratory Initiative on PEdiatric Reference Intervals, http://www.caliperdatabase.com/caliperdatabase/controller?op=menu_reference_intervals&sm=0, accessed 29/08/2013 
1 Canadian Laboratory Initiative on PEdiatric Reference Intervals,, http://www.caliperdatabase.com/caliperdatabase/controller?op=menu_reference_intervals&sm=0, kojem je pristupljeno 29.kolovoza 2013.
In terms of efficacy measurements, the different Numeta formulations were able to maintain or increase body weight. 
U smislu djelotvornosti, dostupne su različite formulacije lijeka Numeta kako bi se održala ili povećala tjelesna težina.
It should be noted that clinical signs may not be identifiable unless hypermagnesaemia is severe. 
Potrebno je zabilježiti da možda neće biti moguće identificirati kliničke znakove osim ako hipermagnezijemija nije teška.
The PRAC considered that a DHPC was needed to communicate the outcome of the present review to relevant healthcare professionals. 
PRAC je smatrao da je DHPC potreban kako bi se iskomunicirao ishod aktualne procjene za relevantne zdravstvene djelatnike.
The PRAC also recommended that the MAH should submit a revised RMP within 3 months after finalisation of the procedure including proposals for evaluating the effectiveness of the risk minimisation activities. 
PRAC je također preporučio da nositelj odobrenja preda revidirani RMP unutar 3 mjeseca nakon dovršetka postupka koji uključuje prijedloge za procjenu djelotvornosti aktivnosti minimizacije rizika.
b. the marketing authorisation holders should implement risk minimisation measures; 
b. nositelji odobrenja za stavljanje lijeka u promet trebaju provesti mjere minimizacije rizika;
Pursuant to Article 6(1)(d) of Regulation (EC) No 1901/2006 as amended, the PDCO's opinion on Numeta was sought in the context of this review. 
U skladu s člankom 6. stavkom 1. točkom (d) Uredbe (EZ) br. 1901/2006, kako je izmijenjena, zatraženo je mišljenje PDCO-a o lijeku Numeta u kontekstu ove procjene.
The levels of magnesium reported in these case reports ranged mainly from 1.025mmol/L to > 1.5mmol/L with levels greater than 1.2mmol/L reported in 9 out of 14 cases while one case was reported as > 1.5mmol/L. 
Razine magnezija prijavljene u ovim slučajevima u rasponu su uglavnom od 1,025 mmol/l do >1,5 mmol/l s razinama većim od 1,2 mmol/l prijavljenim u 14 od 9 slučajeva dok je jedan slučaj prijavljen s vrijednosti od 1,5 mmol/l.
• In addition, the magnesium level should be monitored at baseline and at appropriate intervals thereafter, in accordance with routine clinical practice and the needs of the individual patient. 
• razinu magnezija osim toga treba nadzirati na početku te u odgovarajućim intervalima nakon toga, u skladu s rutinskom kliničkom praksom i potrebama pojedinog bolesnika.
Magnesium is an important electrolyte, particularly for a preterm infant. 
Magnezij je važan elektrolit, posebice za nedonoščad.
In order to prevent any potential harm to premature infants, the MAH decided to recall the product from the market. 
Kako bi se spriječilo bilo koje potencijalno oštećenje nedonoščadi, nositelj odobrenja odlučio je opozvati lijek s tržišta.