FrancophonIA/ELRC3.0 huggingface dataset:
English: Valid data on the acute and developmental toxicity of eprinomectin to dung beetle larvae were provided which indicated that risk quotient values for dung insects were >1.
Croatian: Dostavljeni su valjani podaci o akutnoj i razvojnoj toksičnosti eprinomektina na ličinke balegara prema kojima su vrijednosti kvocijenta rizika za balegare bile >1. Nisu provedena dodatna ispitivanja s ciljem daljnjeg utvrđivanja rizika budući da smjernice na ovom području nisu dostupne.
English: An ERA was provided for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle which was in accordance with VICH and CVMP guidelines.
Croatian: Za Norbonex 5 mg/ml otopinu za polijevanje po koži goveda i mliječnih pasmina stoke dostavljen je ERA u skladu sa smjernicama VICH-a i CVMP-a.
English: The benefit-risk balance is considered positive for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.
Croatian: Omjer koristi i rizika smatra se pozitivnim za Norbonex 5 mg/ml otopinu za polijevanje po koži goveda i mliječnih pasmina stoke.
English: Overall summary of the scientific evaluation of Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Croatian: Ukupni sažetak znanstvene procjene Norbonex 5 mg/ml otopine za polijevanje po koži goveda i mliječnih pasmina stoke
English: Summary of product characteristics
Croatian: Sažetak opisa svojstava
English: Grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Croatian: Razlozi za izdavanje odobrenja za stavljanje VMP-a u promet za Norbonex 5 mg/ml otopinu za polijevanje po koži goveda i mliječnih pasmina stoke
English: Eprinomectin 5 mg/ml
Croatian: Eprinomectin 5 mg/ml poliv, otopina goveda topikalna primjena
English: Strength Pharmaceutical form
Croatian: Doza Farmaceutski oblik
English: MA (EU) Number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: Immediate packaging
Croatian: Unutarnje pakovanje Veličina pakovanja
English: References
Croatian: Referencije
English: Contact our press officer Monika Benstetter
Croatian: Obratite se našoj službenici za odnose s javnošću Monika Benstetter
English: In these cases, stop taking metformin for a short time and speak with your doctor for further instruction.
Croatian: U tim slučajevima prestanite uzimati metformin na kraće vrijeme i obratite se liječniku radi daljnjih uputa.
English: GFR should be assessed before initiation of treatment and at least annually thereafter.
Croatian: GFR treba procijeniti prije započinjanja liječenja te barem jednom godišnje nakon toga.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Croatian: Tel.: +44 (0)20 3660 8427 E-pošta: press@ema.europa.eu
English: The review of metformin-containing medicines was initiated on 28 January 2016 at the request of the Netherlands, under Article 31 of Directive 2001/83/EC.
Croatian: Ponovna ocjena lijekova koji sadrže metformin pokrenuta je 28. siječnja 2016. na zahtjev Nizozemske u skladu s člankom 31. Direktive 2001/83/EZ.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Croatian: Ocjenjivanje je proveo Odbor za lijekove za humanu uporabu (CHMP), odgovoran za pitanja koja se odnose na lijekove za humanu uporabu, te je usvojio mišljenje Agencije.
English: 12 December 2016 EMA/868987/2016
Croatian: EMA/868987/2016
English: Information for healthcare professionals
Croatian: Informacije za zdravstvene radnike
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 12/12/2016.
Croatian: Mišljenje Odbora za lijekove za humanu uporabu (CHMP) proslijeđeno je Europskoj komisiji koja je donijela konačnu pravno obvezujuću odluku primjenjivu u svim državama članicama EU-a 12. prosinca 2016.
English: Clear dosing recommendations and monitoring before and during treatment aim to minimise any possible increased risk in these patients.
Croatian: Jasne preporuke o doziranju te praćenje prije i tijekom liječenja imaju za cilj minimizirati bilo kakav mogući povećani rizik u tih bolesnika.
English: Information for patients
Croatian: Informacije za bolesnike
English: For further information about the centrally authorised medicines, see here.
Croatian: Dodatne informacije o lijekovima odobrenima centraliziranim postupkom pogledajte ovdje.
English: The current product information also varies between countries and products in the EU and is no longer consistent with clinical guidelines.
Croatian: Također, sadašnje informacije o lijeku razlikuju se među državama i lijekovima u Europskoj uniji te više nisu u skladu s kliničkim smjernicama.
English: • Dehydration (significant loss of body fluids) increases the risk of developing lactic acidosis.
Croatian: • Dehidracija (značajan gubitak tjelesnih tekućina) povećava rizik od razvoja laktične acidoze.
English: • If you have any question or concern about your diabetes treatment or your kidney function level, speak with your doctor, nurse or pharmacist.
Croatian: • Imate li pitanja ili vas nešto brine u vezi s liječenjem šećerne bolesti ili razine funkcije bubrega, obratite se liječniku, medicinskoj sestri ili ljekarniku.
English: Medicines containing metformin alone have been authorised nationally in the EU since the 1960s, marketed as Glucophage and other tradenames.
Croatian: Lijekovi koji sadrže samo metformin odobreni su nacionalnim postupkom u Europskoj uniji od 1960-ih, a na tržištu se nalaze pod nazivom Glucophage i drugim nazivima.
English: However, after considering the scientific literature, clinical data, epidemiological studies and clinical guidelines from medical bodies, EMA concluded that the large patient population with moderately reduced kidney function can benefit from use of metformin.
Croatian: Ipak, uzevši u obzir znanstvenu literaturu, kliničke podatke, epidemiološka ispitivanja i kliničke smjernice medicinskih tijela, EMA je zaključila da velika populacija bolesnika s umjerenim smanjenjem funkcije bubrega može imati koristi od primjene metformina.
English: The product information also details risk factors for lactic acidosis which should be reviewed prior to and during treatment.
Croatian: U informacijama o lijeku navedene su i pojedinosti o čimbenicima rizika za laktičnu acidozu koje treba provjeriti prije i tijekom liječenja.
English: If you experience severe vomiting, diarrhoea or fever, are exposed to heat, or drink less fluid than normal, you could become dehydrated.
Croatian: U slučaju teškog povraćanja, proljeva ili vrućice, izloženosti vrućini ili manjem unosu tekućine nego što je normalno, mogli biste dehidrirati.
English: Metformin may increase the risk of a rare but serious complication called lactic acidosis, which occurs when naturally produced lactic acid builds up in the blood faster than it can be removed.
Croatian: Metformin može povećati rizik od rijetke, ali ozbiljne komplikacije pod nazivom laktična acidoza, koja se javlja kada se prirodno proizvedena laktična kiselina nakuplja u krvi brže nego što se može ukloniti.
English: • Several fixed-dose combination products containing metformin are available in Europe (see below).
Croatian: • U Europi je dostupno nekoliko fiksnih kombinacija doza lijekova koji sadrže metformin (pogledajte u nastavku).
English: The dose of metformin should be adapted depending on the patient's kidney function.
Croatian: Dozu metformina treba prilagoditi ovisno o funkciji bubrega bolesnika.
English: The product information for metformincontaining medicines will be updated to reflect the new recommendations and to ensure that the same advice is given to all patients in the EU.
Croatian: Informacije o lijeku za lijekove koji sadrže metformin bit će ažurirane kako bi odražavale nove preporuke i kako bi se osiguralo da svi bolesnici u Europskoj uniji dobiju jednake savjete.
English: The following medicines containing combinations of metformin with other diabetes medicines in the same tablet have been authorised centrally through EMA: pioglitazone/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) and empagliflozin/metformin (Synjardy).
Croatian: Centraliziranim postupkom EMA je odobrila sljedeće lijekove koji sadrže kombinacije metformina i drugih lijekova protiv šećerne bolesti u istoj tableti: pioglitazon/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saksagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), kanagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) i empagliflozin/metformin (Synjardy).
English: Currently, the product information states that metformin must not be used in patients with reduced kidney function because these patients are considered to be at a higher risk of developing lactic acidosis as their kidneys do not remove metformin efficiently enough.
Croatian: Trenutačno, informacije o lijeku navode da se metformin ne smije primjenjivati u bolesnika sa smanjenom funkcijom bubrega jer se smatra da je u tih bolesnika povećan rizik od razvoja laktične acidoze budući da njihovi bubrezi ne uklanjaju metformin dovoljno učinkovito.
English: Use in patients with GFR<30 ml/min is still contraindicated.
Croatian: Primjena u bolesnika u kojih je GFR < 30 ml/min i dalje je kontraindicirana.
English: Companies marketing metformin-containing medicines will be requested to closely monitor and analyse future lactic acidosis cases and report these during upcoming periodic safety reviews in order to follow up on any changes in the frequency of this side effect.
Croatian: Od tvrtki koje stavljaju u promet lijekove koji sadrže metformin zahtijevat će se pomno praćenje i analiza budućih slučajeva laktične acidoze te izvješćivanje o tim slučajevima kod podnošenja budućih periodičkih izvješća o neškodljivosti kako bi se pratile sve promjene u učestalosti te nuspojave.
English: However, for patients with only moderately reduced kidney function any risk can be minimised by careful checking of dose and monitoring, allowing these patients to get the benefits these medicines can provide.
Croatian: Međutim, u bolesnika s tek umjereno smanjenom funkcijom bubrega, rizik se može svesti na najmanju moguću mjeru pažljivom provjerom doze te praćenjem, čime se i takvim bolesnicima omogućava da imaju koristi od tih lijekova.
English: For example, dapagliflozin/metformin (Ebymect, Xigduo) is not recommended in patients with GFR<60 ml/min; canagliflozin/metformin (Vokanamet) and empagliflozin/metformin (Synjardy) are not recommended in patients with GFR<45 ml/min and should not be started in patients with GFR<60 ml/min.
Croatian: Primjerice, u bolesnika u kojih je GFR < 60 ml/min ne preporučuje se dapagliflozin/metformin (Ebymect, Xigduo); u bolesnika s GFR < 45 ml/min ne preporučuje se kanagliflozin/metformin (Vokanamet) i empagliflozin/metformin (Synjardy), a tim se lijekovima ne smije započeti liječenje u bolesnika s GFR < 60 ml/min.
English: In addition, the combination glibenclamide/metformin (Glucovance) has been nationally authorised.
Croatian: Osim toga, nacionalnim postupkom odobrena je kombinacija glibenklamid/metformin (Glucovance).
English: The recommendations were the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function.
Croatian: Preporuke su rezultat provjere koju je provela EMA za lijekove koji sadrže metformin nakon sumnje da postojeći znanstveni dokazi ne opravdavaju kontraindikaciju u bolesnika s umjereno smanjenom funkcijom bubrega.
English: • Some fixed-dose combination products are still not recommended in patients with moderately reduced kidney function because the other active substance in the combination should not be used in these patients.
Croatian: • Neke fiksne kombinacije doza lijekova i dalje se ne preporučuju u bolesnika s umjereno smanjenom funkcijom bubrega jer se druga djelatna tvar u kombinaciji ne smije primjenjivati u tih bolesnika.
English: The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function.
Croatian: Informacije o lijeku za te lijekove ažurirat će se kako bi se izmijenila sadašnja kontraindikacija te navele informacije o dozama, praćenju i mjerama opreza u bolesnika sa smanjenom funkcijom bubrega.
English: If these products are used in patients with reduced kidney function, restrictions and efficacy regarding the other active substance in the combination, the feasibility of dose adjustment and the alternative of using individual tablets should be considered.
Croatian: Ako se ti lijekovi primjenjuju u bolesnika sa smanjenom funkcijom bubrega, potrebno je razmotriti ograničenja i djelotvornost s obzirom na drugu djelatnu tvar u kombinaciji, izvedivost prilagodbe doze i mogućnost uzimanja pojedinačnih tableta.
English: • Patients with reduced kidney function may be at higher risk of lactic acidosis, a rare but serious side effect of metformin medicines caused by build-up of lactic acid in the blood.
Croatian: • Za bolesnike sa smanjenom funkcijom bubrega može postojati veći rizik od laktične acidoze, rijetke, ali ozbiljne nuspojave lijekova koji sadrže metformin, prouzročene nakupljanjem laktične kiseline u krvi.
English: • These latest recommendations will result in harmonisation of product information about the use of metformin in patients with reduced kidney function and the precautions for lactic acidosis across the EU.
Croatian: • Najnovije preporuke rezultirat će usklađivanjem informacija o lijeku s obzirom na primjenu metformina u bolesnika sa smanjenom funkcijom bubrega i mjere opreza za laktičnu acidozu na prostoru Europske unije.
English: Recommendations for patients with kidney impairment updated in product information
Croatian: Ažurirane preporuke za bolesnike s oštećenjem bubrega u informacijama o lijeku
English: Solini, A. et al., ‘Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study', J Am Geriatr Soc, 2013, Vol. 61, p. 1253.
Croatian: Solini, A. et al., ‘Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study', J Am Geriatr Soc, 2013, Vol.
English: • Up to now, metformin medicines were not recommended for patients with moderate to severe reduction of kidney function.
Croatian: • Do sada se lijekovi s metforminom nisu preporučivali bolesnicima s umjerenim do teškim smanjenjem funkcije bubrega.
English: Ekström, N. et al., ‘Effectiveness and safety of metformin in 51675 patients with type 2 diabetes and different levels of renal function: a cohort study from the Swedish National Diabetes Register', BMJ Open, 2012, 2:e001076.
Croatian: Pregledom su ocijenjeni podaci iz velikog broja ispitivanja uključujući: Ekström, N. et al., ‘Effectiveness and safety of metformin in 51675 patients with type 2 diabetes and different levels of renal function: a cohort study from the Swedish National Diabetes Register', BMJ Open, 2012, 2:e001076.
English: • Metformin is used on its own or with other medicines, together with diet and exercise, for the treatment of type 2 diabetes.
Croatian: • Metformin, samostalno ili s drugim lijekovima, primjenjuje se uz dijetnu prehranu i tjelesnu aktivnost za liječenje šećerne bolesti tipa 2.
English: On 13 October 2016, the European Medicines Agency (EMA) concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate] = 30-59 ml/min) for the treatment of type 2 diabetes.
Croatian: Europska agencija za lijekove (EMA) zaključila je 13. listopada 2016. da se lijekovi koji sadrže metformin odsad mogu primjenjivati za liječenje šećerne bolesti tipa 2 i u bolesnika s umjereno smanjenom funkcijom bubrega (GFR [brzina glomerularne filtracije, prema engl. glomerular filtration rate] = 30 - 59 ml/min).
English: • The review of metformin-containing medicines concluded that they can now be used in patients with moderately reduced kidney function (GFR=30-59 ml/min).
Croatian: • Na temelju pregleda lijekova koji sadrže metformin, zaključeno je da se oni sada mogu primjenjivati i u bolesnika s umjereno smanjenom funkcijom bubrega (GFR = 30 - 59 ml/min).
English: et al., ‘Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus', Cochrane Database Syst Rev, 2010, CD00296.
Croatian: Salpeter, S.R. et al., ‘Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus', Cochrane Database Syst Rev, 2010, CD00296.
English: • Reduced doses should be considered for patients with moderate reduction of kidney function according to dosage recommendations provided in the updated product information.
Croatian: • U bolesnika s umjereno smanjenom funkcijom bubrega treba razmotriti primjenu smanjenih doza prema preporukama za doziranje navedenima u ažuriranim informacijama o lijeku.
English: These medicines should still not be used in patients with severely reduced kidney function (GFR less than 30 ml/min).
Croatian: Ovi se lijekovi i dalje ne smiju primjenjivati u bolesnika s teškim smanjenjem funkcije bubrega (vrijednost GFR-a manja od 30 ml/min).
English: et al., ‘Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study', Diabetes Care, 2014, Vol. 37 (8), p.
Croatian: Richy, F.F. et al., ‘Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study', Diabetes Care, 2014, Vol. 37 (8), p.
English: et al., ‘Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study', Diabetes Care, 2014, Vol. 37 (8), p. 2218.
Croatian: Eppenga, W.L. et al., ‘Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study', Diabetes Care, 2014, Vol. 37 (8), p.
English: This recommendation has now changed to allow their use in patients with moderately reduced kidney function (GFR=30-59 ml/min).
Croatian: Ova se preporuka sada promijenila te dopušta primjenu tih lijekova u bolesnika s umjerenim smanjenjem funkcije bubrega (GFR = 30 - 59 ml/min).
English: The contraindication for patients with severely reduced kidney function will remain (GFR less than 30 ml/min).
Croatian: Kontraindikacija će i dalje vrijediti za bolesnike s teškim smanjenjem funkcije bubrega (GFR manji od 30 ml/min).
English: et al., ‘Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, Vol. 312, p. 2668.
Croatian: 2218. Inzucchi, S.E. et al., ‘Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, Vol.
English: Metformin is used together with diet and exercise to improve control of blood glucose (sugar) levels.
Croatian: Metformin je lijek koji se primjenjuje samostalno ili s drugim lijekovima, uz dijetnu prehranu i tjelesnu aktivnost, za liječenje šećerne bolesti tipa 2. Metformin, zajedno s dijetnom prehranom i tjelesnom aktivnošću, služi za poboljšavanje kontrole razine glukoze (šećera) u krvi.
English: Richy, F.F.
Croatian: 61, p. 1253.
English: Content (concentration)
Croatian: Količina (koncentracija)
English: Type 2 (MEF-1)
Croatian: Tip 2 (MEF-1)
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
Croatian: 1 Adsorbirana na aluminijev hidroksid, hidratizirani (0,6 mg Al3+) 2 Kao donja granica pouzdanosti (p= 0,95)
English: Type 3 (Saukett)
Croatian: Tip 3 (Saukett)
English: Strength Pharmaceutical Form
Croatian: Jačina Farmaceutsk i oblik
English: Poliovirus (Inactivated)3 Type 1 (Mahoney)
Croatian: Virus poliomijelitisa (inaktivirani)3 Tip 1 (Mahoney)
English: 4 Or equivalent antigenic quantity determined by a suitable immunochemical method 5 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Croatian: 4 Ili ekvivalentna antigenska količina određena primjerenom imunokemijskom metodom 5 Proizveden tehnologijom rekombinantne DNK na stanicama kvasca Hansenula polymorpha
English: 3 Produced on Vero cells
Croatian: 3 Umnožen na Vero stanicama
English: Tetanus Toxoid
Croatian: Toksoid tetanusa
English: (Polyribosylribitol Phosphate) conjugated to Tetanus protein
Croatian: (poliribozilribitolfosfat (PRP)) konjugiran na protein tetanusa
English: --1 One dose1 (0.5 ml) contains: Diphtheria Toxoid
Croatian: Jedna doza1 (0,5 ml) sadrži: Toksoid difterije
English: Hepatitis B surface antigen5
Croatian: Površinski antigen virusa hepatitisa B5
English: 10 vials
Croatian: 10 bočica
English: Bordetella pertussis antigens Pertussis Toxoid
Croatian: Antigeni bakterije Bordetella pertussis Toksoid hripavca
English: Pack size vial (glass)
Croatian: Veličina pakovanja bočica (staklo)
English: 10 pre-filled syringes
Croatian: 10 napunjenih štrcaljki
English: Haemophilus influenzae type b polysaccharide
Croatian: Polisaharid bakterije Haemophilus influenzae tip b
English: 1 pre-filled syringe
Croatian: 1 napunjena štrcaljka
English: Filamentous Haemagglutinin
Croatian: Filamentozni hemaglutinin
English: 1 pre-filled syringe + 2 needles
Croatian: 1 napunjena štrcaljka + 2 igle
English: 1 pre-filled syringe + 1 needle
Croatian: 1 napunjena štrcaljka + 1 igla
English: Immediate Packaging
Croatian: Način primjene Unutarnji spremnik
English: (Invented) name
Croatian: Broj EU odobrenja (Zaštićeno ime)
English: Content (concentration)
Croatian: Sadržaj (koncentracija)
English: MA (EU) number
Croatian: Broj (EU) odobrenja
English: Strength Pharmaceutical Form
Croatian: (Zaštićeno) ime Jačina Farmaceutski oblik
English: 1 vial + 1 syringe + 1 needle + 1 adaptor + 2 alcohol pads
Croatian: 1 bočica + 1 štrcaljka+ 1 igla + 1 adapter + 2 jastučića natopljena alkoholom2 napunjene štrcaljke + 2 jastučića natopljena alkoholom2 napunjene brizgalice + 2 jastučića natopljena alkoholom
English: EU/1/19/1356/001 IDACIO 40 mg/0.8 ml
Croatian: 40 mg/0,8 ml
English: Immediate Packaging
Croatian: Veličina pakiranja
English: Solution for injection
Croatian: Put primjene Unutarnje pakiranje
English: Subcutaneous use vial (glass)
Croatian: Otopina za injekciju bočica (staklo) 0,8 ml (40 mg/0,8ml)
English: MA (EU) number (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: The medicine should be taken without food.
Croatian: Lijek treba uzimati bez hrane.
English: Further information can be found in the summary of the risk management plan.
Croatian: Dodatne informacije možete pronaći u sažetku plana upravljanja rizikom
English: These are usually mild or moderate in severity and temporary.
Croatian: Nuspojave su najčešće blage ili umjerene u ozbiljnosti i privremene.
English: However, continued treatment would be necessary to maintain the beneficial effects.
Croatian: No, nastavljena terapija bila bi potrebna kako bi se održalo korisno djelovanje.
English: As a result, patients fall asleep and wake up at unusual times.
Croatian: Rezultat poremećaja je da bolesnici zaspu i probude se u neobična vremena.
English: This summary was last updated in 07-2015.
Croatian: Sažetak je posljednji put ažuriran u 07. 2015.
English: Improved results were seen in a subset of patients after 7 months of treatment, which indicate that patients may take weeks or months to respond.
Croatian: Poboljšani rezultati uočeni su u podskupini bolesnika nakon 7 mjeseci terapije, što je indikativno da je bolesnicima potrebno nekoliko tjedana ili mjeseci da odgovore na terapiju.