natgillin/translations-raw huggingface dataset:
c.T552A or c.T552G 
c.T552A ili c.T552G
c.G242A or c.G243A 
c.G242A ili c.G243A
c.261G>C or c.261G>T 
c.261G>C ili c.261G>T
c.G734A or c.G735A 
c.G734A ili c.G735A
c.241T>C or c.241T>A 
c.241T>C ili c.241T>A
c.187T>A or c.188G>C 
c.187T>A ili c.188G>C
c.612G>T or c.612G>C 
c.612G>T ili c.612G>C
Psychiatric disorders 
Psihijatrijski poremećaji depresija
c.C233G or c.C233A 
c.C233G ili c.C233A
c.124A>C or c.124A>T 
c.124A>C ili c.124A>T
c.C305G or c.C305A 
c.C305G ili c.C305A
c.552T>A or c.552T>G 
c.552T>A ili c.552T>G
c.G132T or c.G132C 
c.G132T ili c.G132C
c.G1074T or c.G1074C 
c.G1074T ili c.G1074C
c.G243T or c.G243C 
c.G243T ili c.G243C
c.242G>A or c.243G>A 
c.242G>A ili c.243G>A
Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively. 
Najčešća nuspojava zabilježena pri dozama lijeka Galafold od najviše 1250 mg bila je glavobolja, odnosno pri dozama od najviše 2000 mg omaglica.
If more than 12 hours has passed you should resume taking Galafold at the next planned dosing day and time according to your every other day dosing schedule.. Do not take two capsules to make up for your missed dose. 
Ako je prošlo više od 12 sati, trebate nastaviti uzimati Galafold onog dana i u ono doba za koje je predviđena sljedeća doza u skladu s rasporedom doziranja svakog drugog dana.
c.G1081A or c.G1081C 
c.G1081A ili c.G1081C
c.G888A or c.G888T or c.G888C M296I 
c.G888A ili c.G888T ili c.G888C M296I
UNKNOWN (del Exon3?) 
NEPOZNATO (del Exon3?)
c.T258G or c.T258A 
c.T258G ili c.T258A
c.471G>C or c.471G>T 
c.471G>C ili c.471G>T
c.285G>T or c.285G>C 
c.285G>T ili c.285G>C
c.C747G or c.C747A 
c.C747G ili c.C747A
c.279C>G or c.279C>A 
c.279C>G ili c.279C>A
c.T960G or c.T960A 
c.T960G ili c.T960A
c.207C>A or c.207C>G 
c.207C>A ili c.207C>G
c.982G>A or c.982G>C 
c.982G>A ili c.982G>C
c.519C>A or c.519C>G 
c.519C>A ili c.519C>G
c.C453G or c.C453A 
c.C453G ili c.C453A
c.G609C or c.G609T 
c.G609C ili c.G609T
Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m 
Ne preporučuje se primjena lijeka Galafold u bolesnika s Fabryjevom bolešću kod kojih je procijenjena vrijednost GFR-a manja od 30 mL/min/1,73 m
c.A840T or c.A840C 
c.A840T ili c.A840C
c.131G>A or c.132G>A 
c.131G>A ili c.132G>A
c.233C>G or c.233C>A 
c.233C>G ili c.233C>A
c.T280A or c.G281C 
c.T280A ili c.G281C
c.G567C or c.G567T 
c.G567C ili c.G567T
c.243G>T or c.243G>C 
c.243G>T ili c.243G>C
c.G144T or c.G144C 
c.G144T ili c.G144C
• Stomach ache 
• suha usta
c.T610C or c.T610A 
c.T610C ili c.T610A
c.T514A or c.G515C 
c.T514A ili c.G515C
c.1081G>A or c.1081G>C 
c.1081G>A ili c.1081G>C
c.1074G>T or c.1074G>C 
c.1074G>T ili c.1074G>C
c.816C>A or c.816C>G 
c.816C>A ili c.816C>G
c.G288A or c.G288T or c.G288C M96I 
c.G288A ili c.G288T ili c.G288C M96I
c.258T>G or c.258T>A 
c.258T>G ili c.258T>A
c.525C>G or c.525C>A 
c.525C>G ili c.525C>A
c.T859C or c.T859A 
c.T859C ili c.T859A
c.A588T or c.A588C 
c.A588T ili c.A588C
c.C897G or c.C897A 
c.C897G ili c.C897A
Lot 
Louth
c.540G>C or c.540G>T 
c.540G>C ili c.540G>T
c.132G>T or c.132G>C 
c.132G>T ili c.132G>C
UNKNOWN (del Exon1_2?) 
NEPOZNATO (del Exon1_2?)
c.T408A or c.T408G 
c.T408A ili c.T408G
c.T154A or c.G155C 
c.T154A ili c.G155C
c.166T>A or c.167G>C 
c.166T>A ili c.167G>C
UNKNOWN (del Exon5_7?) 
NEPOZNATO (del Exon5_7?)
c.G831T or c.G831C 
c.G831T ili c.G831C
c.609G>C or c.609G>T 
c.609G>C ili c.609G>T
c.103G>C or c.103G>A 
c.103G>C ili c.103G>A
c.T369G or c.T369A 
c.T369G ili c.T369A
c.960T>G or c.960T>A 
c.960T>G ili c.960T>A
c.G141C or c.G141T 
c.G141C ili c.G141T
c.881T>G or c.881T>A 
c.881T>G ili c.881T>A
c.G830A or c.G831A 
c.G830A ili c.G831A
c.707G>A or c.708G>A 
c.707G>A ili c.708G>A
Paraesthesia Dizziness Hypoaesthesia 
Poremećaji živčanog sustava glavobolja parestezija omaglica hipoestezija
c.305C>G or c.305C>A 
c.305C>G ili c.305C>A
c.144G>T or c.144G>C 
c.144G>T ili c.144G>C
c.G860A or c.G861A 
c.G860A ili c.G861A
c.141G>C or c.141G>T 
c.141G>C ili c.141G>T
c.T465A or c.T465G 
c.T465A ili c.T465G
c.453C>G or c.453C>A 
c.453C>G ili c.453C>A
c.108G>C or c.108G>T 
c.108G>C ili c.108G>T
c.610T>C or c.610T>A 
c.610T>C ili c.610T>A
c.567G>C or c.567G>T 
c.567G>C ili c.567G>T
c.G485A or c.G486A 
c.G485A ili c.G486A
Dyspnoea Epistaxis 
Prijavljivanje nuspojava
c.C966A or c.C966G 
c.C966A ili c.C966G
c.C456A or c.C456G 
c.C456A ili c.C456G
c.830G>A or c.831G>A 
c.830G>A ili c.831G>A
c.G71A or c.G72A 
c.G71A ili c.G72A
c.888G>A or c.888G>T or c.888G>C 
c.888G>A ili c.888G>T ili c.888G>C
• Indigestion (dyspepsia) 
• trnci u udovima (parestezija)
c.T676C or c.T676A 
c.T676C ili c.T676A
c.734G>A or c.735G>A 
c.734G>A ili c.735G>A
After follow up in the OLE, the mean change from baseline in LVMi at Month 36 was -8.3 (95% CI: -17.1, 0.4; n=25) and at Month 48 was -9.1 (95% CI: -20.3, 2.0; n=18). 
Nakon praćenja u otvorenom nastavku ispitivanja, srednja vrijednost promjene u odnosu na početnu vrijednost LVMi u 36. mjesecu iznosila je -8,3 (95 % CI: -17,1; 0,4; n = 25), a u 48. mjesecu iznosila je -9,1 (95 % CI: -20,3; 2,0; n = 18).
c.870G>A or c.870G>C or c.870G>T 
c.870G>A ili c.870G>C ili c.870G>T
c.G108C or c.G108T 
c.G108C ili c.G108T
c.G439A or c.G439C 
c.G439A ili c.G439C
c.G861C or c.G861T 
c.G861C ili c.G861T
c.859T>C or c.859T>A 
c.859T>C ili c.859T>A
c.860G>A or c.861G>A 
c.860G>A ili c.861G>A
After follow up in the OLE, the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline at Month 36 was -30.0 (95%) CI: -57.9, -2.2; n=4) and at Month 48 
Nakon praćenja u otvorenom nastavku ispitivanju, srednja vrijednost promjene u odnosu na početnu vrijednost LVMi u bolesnika s hipertrofijom lijevog ventrikula na početku u 36. mjesecu iznosila je -30,0 (95 % CI: -57,9; -2,2; n = 4), a u 48. mjesecu iznosila je -33,1 (95 % CI: -60,9; -5,4; n = 4).
c.831G>T or c.831G>C 
c.831G>T ili c.831G>C
c.G394A or c.G394C 
c.G394A ili c.G394C
c.T648A or c.T648G 
c.T648A ili c.T648G
c.485G>A or c.486G>A 
c.485G>A ili c.486G>A
c.439G>A or c.439G>C 
c.439G>A ili c.439G>C
c.966C>A or c.966C>G 
c.966C>A ili c.966C>G
c.514T>A or c.515G>C 
c.514T>A ili c.515G>C
c.G486C or c.G486T 
c.G486C ili c.G486T
c.897C>G or c.897C>A 
c.897C>G ili c.897C>A
In a single dose study with Galafold in non-Fabry subjects with varying degrees of renal insufficiency, exposures were increased by 4.3-fold in subjects with severe renal impairment (GFR < 30 mL/min/1.73 m 
Galafold nije ispitivan u bolesnika s Fabryjevom bolešću koji imaju GFR manji od 30 ml/min/1,73 m U ispitivanju koje je uključivalo davanje jedne doze Galafolda u ispitanika koji nisu imali Fabryjevu bolest s različitim stupnjevima bubrežne insuficijencije, izloženosti su se povećale 4,3 puta u ispitanika s teškim oštećenjem bubrega (GFR < 30 ml/min/1,73 m
c.465T>A or c.465T>G 
c.465T>A ili c.465T>G
c.861G>C or c.861G>T 
c.861G>C ili c.861G>T
c.A868C or c.A868T 
c.A868C ili c.A868T
c.394G>A or c.394G>C 
c.394G>A ili c.394G>C
After an average of 3.4 years of treatment, the mean annualised rate of change in eGFRCKD-EPI was -0.74 mL/min/1.73 m 
Nakon prosječnog razdoblja od 3,4 godine liječenja, srednja godišnja stopa promjene u eGFRCKD-EPI iznosila je -0,74 mL/min/1,73 m2 (95 % CI: -1,89; 0,40; n = 41).
c.T667A or c.G668C 
c.T667A ili c.G668C
c.588A>T or c.588A>C 
c.588A>T ili c.588A>C
c.408T>A or c.408T>G 
c.408T>A ili c.408T>G
c.154T>A or c.155G>C 
c.154T>A ili c.155G>C
c.C666A or c.C666G 
c.C666A ili c.C666G
c.71G>A or c.72G>A 
c.71G>A ili c.72G>A
c.T834G or c.T834A 
c.T834G ili c.T834A
c.102T>G or c.102T>A 
c.102T>G ili c.102T>A
c.T70C or c.T70A 
c.T70C ili c.T70A
c.T102G or c.T102A 
c.T102G ili c.T102A
c.288G>A or c.288G>T or c.288G>C 
c.288G>A ili c.288G>T ili c.288G>C
c.T894G or c.T894A 
c.T894G ili c.T894A
c.G837C or c.G837T 
c.G837C ili c.G837T
c.708G>C or c.708G>T 
c.708G>C ili c.708G>T
c.837G>C or c.837G>T 
c.837G>C ili c.837G>T
g.?_?dup c.?_?dup 
Promjena slijeda u proteinu g.?_?dup c.?_?dup
c.G963C or c.G963T 
c.G963C ili c.G963T
c.784T>A or c.784T>C 
c.784T>A ili c.784T>C
c.T687A or c.T687G 
c.T687A ili c.T687G
c.676T>C or c.676T>A 
c.676T>C ili c.676T>A
c.T402G or c.T402A 
c.T402G ili c.T402A
c.G936T or c.G936C 
c.G936T ili c.G936C
c.369T>G or c.369T>A 
c.369T>G ili c.369T>A
c.T484C or c.T484A 
c.T484C ili c.T484A
c.747C>G or c.747C>A 
c.747C>G ili c.747C>A
UNKNOWN (del Exon3_7?) 
NEPOZNATO (del Exon3_7?)
BLISTER SLEEVE 
BLISTER KARTICA
Galafold 123 mg hard capsules Migalastat 
Galafold 123 mg tvrde kapsule migalastat
c.456C>A or c.456C>G 
c.456C>A ili c.456C>G
c.G707A or c.G708A 
c.G707A ili c.G708A
c.70T>C or c.70T>A 
c.70T>C ili c.70T>A
c.G772C or c.G772A 
c.G772C ili c.G772A
c.G978C or c.G978T 
c.G978C ili c.G978T
Disease Substrate 
Supstrat bolesti
c.486G>C or c.486G>T 
c.486G>C ili c.486G>T
c.840A>T or c.840A>C 
c.840A>T ili c.840A>C
c.G720C or c.G720T 
c.G720C ili c.G720T
UNKNOWN (del Exon2_3?) 
NEPOZNATO (del Exon2_3?)
c.G778C or c.G778A 
c.G778C ili c.G778A
c.834T>G or c.834T>A 
c.834T>G ili c.834T>A
c.T784A or c.T784C 
c.T784A ili c.T784C
c.720G>C or c.720G>T 
c.720G>C ili c.720G>T
c.729G>C or c.729G>T 
c.729G>C ili c.729G>T
c.G729C or c.G729T 
c.G729C ili c.G729T
c.G708C or c.G708T 
c.G708C ili c.G708T
c.402T>G or c.402T>A 
c.402T>G ili c.402T>A
c.978G>C or c.978G>T 
c.978G>C ili c.978G>T
c.A886T or c.A886C 
c.A886T ili c.A886C
c.72G>C or c.72G>T 
c.72G>C ili c.72G>T
c.T706C or c.T706A 
c.T706C ili c.T706A
c.894T>G or c.894T>A 
c.894T>G ili c.894T>A
c.648T>A or c.648T>G 
c.648T>A ili c.648T>G
c.G785A or c.G786A 
c.G785A ili c.G786A
c.868A>C or c.868A>T 
c.868A>C ili c.868A>T
c.G678T or c.G678C 
c.G678T ili c.G678C
c.484T>C or c.484T>A 
c.484T>C ili c.484T>A
c.702T>G or c.702T>A 
c.702T>G ili c.702T>A
c.677G>A or c.678G>A 
c.677G>A ili c.678G>A
c.772G>C or c.772G>A 
c.772G>C ili c.772G>A
c.666C>A or c.666C>G 
c.666C>A ili c.666C>G
c.678G>T or c.678G>C 
c.678G>T ili c.678G>C
c.G72C or c.G72T 
c.G72C ili c.G72T
c.706T>C or c.706T>A 
c.706T>C ili c.706T>A
c.T702G or c.T702A 
c.T702G ili c.T702A
c.785G>A or c.786G>A 
c.785G>A ili c.786G>A
c.778G>C or c.778G>A 
c.778G>C ili c.778G>A
Galafold 123 mg hard capsules 
Galafold 123 mg tvrde kapsule
c.G786C or c.G786T 
c.G786C ili c.G786T
c.936G>T or c.936G>C 
c.936G>T ili c.936G>C
c.667T>A or c.668G>C 
c.667T>A ili c.668G>C
c.G677A or c.G678A 
c.G677A ili c.G678A
c.963G>C or c.963G>T 
c.963G>C ili c.963G>T
c.687T>A or c.687T>G 
c.687T>A ili c.687T>G
Protein Sequence change c.744delT 
Promjena slijeda u proteinu c.256delT
c.786G>C or c.786G>T 
c.786G>C ili c.786G>T
Protein sequence change c.126G>A or c.126G>C or c.126G>T 
c.126G>A ili c.126G>C ili c.126G>T
c.T798A or c.T798G 
c.T798A ili c.T798G
(dyspnoea) 
(dispepsija)
c.886A>T or c.886A>C 
c.886A>T ili c.886A>C
c.798T>A or c.798T>G 
c.798T>A ili c.798T>G
c.789T>A or c.789T>G 
c.789T>A ili c.789T>G
c.T789A or c.T789G 
c.T789A ili c.T789G
In the ERT-naïve trial, Galafold resulted in a statistically significant decrease in LVMi (p< 0.05); the mean change from baseline in LVMi at Month 18 to 24 was -7.7 (95% CI: -15.4, -0.01; n=27). 
U ispitivanju s bolesnicima koji nisu prethodno primali ERT, Galafold je doveo do statistički značajnog smanjenja LVMi (p < 0,05); srednja vrijednost promjene u odnosu na početnu vrijednost LVMi od 18. do 24. mjeseca iznosila je -7,7 (95 % CI: -15,4; -0,01; n = 27).
(paraesthesia) 
(dispneja)
Amicus Therapeutics GmbH Tel.: + 49 89 2488 79810 / 0800 000 2038 E-Mail: MedInfo@amicusrx.com 
+ 49 89 2488 79810 / 0800 000 2038 E-Mail: MedInfo@amicusrx.com
Musculoskeletal and connective tissue disorders 
Poremećaji bubrega i mokraćnog sustava proteinurija
Defaecation urgency Dyspepsia 
Poremećaji probavnog sustava proljev mučnina bol u trbuhu zatvor suha usta urgencija za defekaciju dispepsija
(torticollis) 
(pruritus)
During the open-label extension, statistically significant (p<0.05) improvements from baseline were observed in the diarrhoea and indigestion domains, with a trend of improvement in the constipation domain. 
u odnosu na početnu vrijednost primijećena su u području proljeva i probavnih tegoba, uz trend poboljšanja u području konstipacije.
Table 2: Galafold (migalastat) amenability table 
Tablica 2.: Tablica mutacija koje omogućuju odgovili na lijek Galafold (migalastat) Promjena nukleotida
PULL out card on the right 3. 
1. PRITISNITE i držite jezičak s lijeve strane 2. IZVUCITE karticu s desne strane 3. GURNITE kapsulu kroz foliju 4. GURNITE karticu natrag u držač
The change from baseline to Month 18 in LVMi (g/m 2) in patients with left ventricular hypertrophy (females with baseline LVMi > 95 g/m and males with baseline LVMi > 115 g/m2) was -8.4 (95% CI: -15.7, 2.6; n=13) for migalastat and 4.5 (95% CI: -10.7, 18.4; n=5) for ERT. After 30 months treatment with Galafold, the mean change from baseline in LVMi was -3.8 (95% CI: -8.9, 1.3; n=28) and the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline was -10.0 (95% CI: -16.6, -3.3; n=10). 
Nakon 30 mjeseci liječenja lijekom Galafold, srednja vrijednost promjene od početne vrijednosti u LVMi bila je -3,8 (95 % CI: -8,9; 1,3; n = 28), a srednja vrijednost promjene od početne vrijednosti u LVMi u bolesnika s hipertrofijom lijevog ventrikula na početku bila je -10,0 (95 % CI: -16,6; -3,3; n = 10).
Protein Sequence change c.290delC 
Promjena slijeda u proteinu c.1208delT
Do not take Galafold if you: 
Što morate znati prije nego počnete uzimati Galafold Nemojte uzimati Galafold:
Further information on Halimatoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Više informacija o lijeku Halimatoz možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Halimatoz and 63% with Humira. 
Udio bolesnika u kojih je nakon 16 tjedana liječenja zabilježeno smanjenje simptoma od najmanje 75 % iznosio je 68 % za lijek Halimatoz i 63 % za lijek Humira.
This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
Drugim riječima, Halimatoz je vrlo sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u EU-u.
The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Halimatoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose. 
Doza i učestalost injekcije ovisi o stanju koje je potrebno liječiti, a doza za djecu uglavnom se izračunava u skladu s tjelesnom težinom djeteta; budući da je Halimatoz dostupan samo u dozama od 40 mg, nije prikladan za djecu kojoj je potrebna niža doza.
After training, patients or their carers may inject Halimatoz if their doctor considers it appropriate. 
Nakon obuke bolesnici ili njihovi njegovatelji mogu ubrizgati lijek Halimatoz ako to njihov liječnik smatra primjerenim.
What measures are being taken to ensure the safe and effective use of Halimatoz? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Halimatoz?
The company that markets Halimatoz must provide educational packs for doctors who prescribe the medicine. 
Tvrtka koja stavlja na tržište lijek Halimatoz mora dostaviti edukacijske pakete za liječnike koji propisuju taj lijek.
Like other medicines of its class, Halimatoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab. 
Kao i drugi lijekovi u tom razredu, Halimatoz može utjecati na sposobnost imunosnog sustava da se bori protiv infekcija i raka, pa su zabilježeni slučajevi ozbiljnih infekcija i raka krvi u bolesnika koji su liječeni adalimumabom.
Halimatoz is a medicine that acts on the immune system and is used to treat the following conditions: 
Halimatoz je lijek koji djeluje na imunosni sustav te se primjenjuje za liječenje sljedećih stanja:
The reference medicine for Halimatoz is Humira. 
Referentni lijek za lijek Halimatoz je Humira.
Halimatoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body). 
Halimatoz se ne smije primjenjivati u bolesnika s aktivnom tuberkulozom ili drugim teškim infekcijama ni u bolesnika s umjerenim do teškim zatajenjem srca (nesposobnost srca da pumpa dovoljne količine krvi u tijelu).
Side effects reported with Halimatoz are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Halimatoz pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Halimatoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks. 
Halimatoz je dostupan kao otopina za potkožnu injekciju u napunjenoj štrcaljki ili brizgalici te se obično primjenjuje svaka dva tjedna.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Halimatoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way. 
Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Halimatoz ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Humira te se u tijelu raspoređuje na isti način.
Because Halimatoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Halimatoz. 
Budući da je lijek Halimatoz biosličan lijek, ispitivanja učinkovitosti i sigurnosti adalimumaba provedena za lijek Humira nije potrebno ponavljati za lijek Halimatoz.
An overview of Halimatoz and why it is authorised in the EU 
Pregled informacija o lijeku Halimatoz i zašto je odobren u EU-u
What is Halimatoz and what is it used for? 
Što je Halimatoz i za što se primjenjuje?
The active substance in Halimatoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF). 
Djelatna tvar u lijeku Halimatoz, adalimumab, monoklonsko je protutijelo (vrsta proteina) namijenjeno prepoznavanju i vezivanju za tvar u tijelu zvanu faktor tumorske nekroze (TNF).
Other information about Halimatoz 
Ostale informacije o lijeku Halimatoz
Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. 
Halimatoz se prvenstveno koristi u odraslih osoba kod ozbiljnog, umjereno ozbiljnog stanja bolesti ili onog koje se pogoršava, odnosno kad bolesnici ne mogu primiti drugu terapiju.
Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition). 
Druge rijetke ozbiljne nuspojave (koje se mogu javiti u manje od 1 na 1 000 osoba) uključuju poremećaj u kojemu koštana srž više ne proizvodi krvne stanice, poremećaje živaca, lupus i poremećaje slične lupusu (pri čemu imunosni sustav bolesnika napada tkiva u vlastitom organizmu, uzrokujući upalu i oštećenja organa) i Stevens-Johnsonov sindrom (ozbiljna bolest kože).
Halimatoz contains the active substance adalimumab and is a ‘biosimilar medicine'. 
Halimatoz sadrži djelatnu tvar adalimumab te je „biosličan lijek”.
The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain. 
Najčešće nuspojave povezane s adalimumabom (zabilježene u više od 1 na 10 bolesnika) su infekcije (uključujući infekcije nosa, grla i sinusa), reakcije na mjestu primjene injekcije (crvenilo, svrbež, krvarenje, bol ili oticanje), glavobolja i bol u mišićno-koštanom sustavu.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Halimatoz have also been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Halimatoz nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
(collections of pus) and scarring on the skin; 
(nakupljanje gnoja) i ožiljke na koži;
What are the risks associated with Halimatoz? 
Koji su rizici povezani s lijekom Halimatoz?
Why is Halimatoz authorised in the EU? 
Zašto je lijek Halimatoz odobren u EU-u?
• polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints); 
• poliartikularnog juvenilnog idiopatskog artritisa i aktivnog artritisa povezanog s entezitisom (obje su rijetke bolesti koje uzrokuju upalu zglobova);
• axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation; 
• aksijalnog spondiloartritisa (upale kralježnice koja uzrokuje bolove u leđima), uključujući i ankilozantni spondilitis, te kad rendgenska snimka ne pokazuje bolest, no postoje jasni znaci upale;
For more information on the use of Halimatoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist. 
Za više informacija o primjeni lijeka Halimatoz za sva stanja, kao i kada se može primjenjivati u djece, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
As for all medicines, data on the use of Halimatoz are continuously monitored. 
Kao za sve lijekove, podatci o primjeni lijeka Halimatoz kontinuirano se prate.
Halimatoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Halimatoz is used. 
Halimatoz se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju bolesti za koje se Halimatoz koristi.
Therefore, the Agency's view was that, as for Humira, the benefits of Halimatoz outweigh the identified risks and it can be authorised. 
Stoga je stav Agencije da korist kod lijeka Halimatoz, kao i kod lijeka Humira, nadmašuje identificirane rizike te da lijek može biti odobren.
TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Halimatoz is used to treat. 
TNF pridonosi nastanku upale i pronađen je u visokim koncentracijama u bolesnika s bolestima koje se liječe lijekom Halimatoz.
Eye specialists treating uveitis should also take advice from doctors who have experience of using Halimatoz. 
Očni specijalisti koji liječe uveitis trebali bi također poslušati savjete liječnika s iskustvom u primjeni lijeka Halimatoz.
For more information about using Halimatoz, see the package leaflet or contact your doctor or pharmacist. 
Za više informacija o primjeni lijeka Halimatoz pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
Laboratory studies comparing Halimatoz with Humira have shown that the active substance in Halimatoz is highly similar to that in Humira in terms of structure, purity and biological activity. 
Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Halimatoz i Humira pokazala su da je djelatna tvar u lijeku Halimatoz vrlo slična djelatnoj tvari u lijeku Humira u pogledu strukture, čistoće i biološke aktivnosti.
All these data were considered sufficient to conclude that Halimatoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses. 
Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Halimatoz za odobrene indikacije djelovati na isti način kao lijek Humira u pogledu djelotvornosti i sigurnosti.