natgillin/translations-raw huggingface dataset:
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
Accidental self-injection may cause local reactions such as irritation, granulomas, or severe anaphylactic reactions in sensitive people. 
Nehotično samoinjiciranje VMP-a može uzrokovati lokalne reakcije kao što su iritacije, granulomi ili ozbiljne anafilaktičke reakcije u osjetljivih osoba.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ . 
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
Meat and offal: 70 days. 
Meso i jestive iznutrice: 70 dana.
It has coccidiocidal activity against all intracellular development stages of the genera Cystoisospora, that is, merogony (asexual multiplication) and gamogony (sexual phase). 
Ima kokcidiocidno djelovanje u odnosu na sve unutarstanične stadije razvoja rodova Cystoisospora, tj. merogonije (aseksualno umnožavanje) i gamogonije (spolna faza).
It plays a major role in the transport of oxygen via haemoglobin and myoglobin, as well as having a key role in enzymes, such as cytochromes, catalases, and peroxidases. 
Ima važnu ulogu u prijenosu kisika putem hemoglobina i mioglobina, kao i ključnu ulogu za djelovanje enzima, kao što su citokromi, katalaze i peroksidaze.
The product must not be administered more than once. 
VMP se ne smije primijeniti više nego jednom.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after "EXP". 
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji poslije "EXP".
Following intramuscular injection, gleptoferron is absorbed and metabolised to release the iron for use and/or storage in accordance with the nutritional status of the animal. 
Nakon intramuskularne injekcije, gleptoferon se apsorbira i metabolizira i otpušta željezo za iskorištavanje i/ili skladištenje u skladu s nutritivnim stanjem životinje.
The principal route of excretion is via the faeces. 
Glavni put izlučivanja je putem izmeta.
Once clinical signs of coccidiosis are evident, damage to the small intestine will have already occurred. 
Kada se uoče klinički znakovi kokcidioze, već je došlo do oštećenja tankog crijeva.
The responsible veterinarian should take into account the results of clinical examinations and/or analysis of faecal samples and/or histological findings which confirmed the presence of C. suis in a previous infection episode on the farm. 
Odgovorni veterinar treba uzeti u obzir rezultate kliničkih ispitivanja i / ili analize uzoraka fekalija i / ili histoloških nalaza koji su potvrdili prisutnost C. suis u prethodnoj pojavi kokcidioze na farmi.
Antiparasitic agents/ Agents acting against protozoa 
Antiparazitsk a sredstva / sredstva koja djeluju protiv protozoa
It is not recommended to use the veterinary medicinal product in piglets weighing less than 0.9 kg. 
Ne preporučuje se uporaba veterinarsko-medicinskog proizvoda u prasadi mase manje od 0,9 kg.
Not for use in animals from which eggs are produced for human consumption. 
Nije za uporabu kod životinja od kojih se jaja proizvode za prehranu ljudi
In safety studies, after any overdosage, an increased susceptibility for (systemic) bacterial disease, arthritis, and abscess formation was observed and a dose-dependent increase in mortality could not be excluded. 
U ispitivanjima sigurnosti, nakon predoziranja, uočena je povećana osjetljivost na (sistemsku) bakterijsku bolest, artritis i nastanak apscesa, a smrtnost ovisna o povećanju doze nije se mogla isključiti.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/04/2019 
Datum prvog odobrenja: 23/04/2019
Pigs (piglets 24 to 96 hours after birth) 
Svinje (prasad 24 do 96 sati nakon prašenja)
Iron (as gleptoferron) 
Željezo (u obliku gleptoferona)
The tolerance of the product after repeated administrations has not been assessed. 
Tolerancija na VMP nakon ponovljenih primjena nije procijenjena.
Not for use in animals from which milk is produced for human consumption. 
Nije za uporabu kod životinja od kojih se mlijeko proizvodi za prehranu ljudi.
These deaths have been associated with genetic factors or deficiencies of vitamin E and/or selenium. 
Uginuća su bila povezana s genetskim faktorima ili nedostatkom vitamina E i/ili selena.
Pregnant women and women intending to conceive should avoid contact with the veterinary medicinal product, especially accidental self-injection. 
Trudnice i žene koje planiraju začeti trebaju izbjegavati kontakt s VMP-om, posebno nehotično samoinjiciranje.
Deaths have been reported very rarely in piglets following the administration of parenteral iron injections. 
Vrlo rijetko su zabilježena uginuća prasadi nakon primjene parenteralnih injekcija željeza.
Translucent multi-layered plastic (polypropylene/ethylene vinyl alcohol/polypropylene) vials with bromobutyl rubber stoppers coated with a fluor film and aluminium and plastic flip capsules, containing 100 ml, 250 ml or 500 ml. 
Prozirne višeslojne plastične bočice (polipropilen/etilen vinil alkohol/polipropilen) s bromobutilnim gumenim čepovima obloženim fluor filmom i aluminijskom i plastičnom kapicom, od 100 ml, 250 ml ili 500 ml.
If more injections than that are needed, the use of a multiple-dose syringe is recommended. 
Ako je potreban veći broj primjena, preporučuje se koristiti višedozne štrcaljke.
People with known hypersensitivity to iron (as gleptoferron complex) or toltrazuril or any of the excipients should avoid contact with the veterinary medicinal product. 
Osobe preosjetljive na željezo (u obliku gleptoferona) ili na toltrazuril ili na bilo koju od pomoćnih tvari trebaju izbjegavati kontakt s veterinarsko-medicinskim proizvodom.
Toltrazuril is a triazinon derivative and an antiprotozoal agent. 
Toltrazuril je derivat triazinona i antiprotozoik.
Toltrazuril is primarily metabolised into toltrazuril sulfone. 
Toltrazuril se primarno metabolizira u toltrazuril sulfon.
Phenol 
Fenol
Overdose (symptoms, emergency procedures, antidotes), if necessary: 
Predoziranje (simptomi, hitni postupci, antidoti):
TARGET SPECIES Pigs (piglets 24 to 96 hours after birth) 
CILJNE VRSTE ŽIVOTINJA Svinje (prasad 24 do 96 sati nakon prašenja)
Wash hands after use. 
Nakon upotrebe VMP-a potrebno je oprati ruke.
All mammalia n food producing species 
Svi sisavci za proizvodnju hrane za ljude
Piglet deaths have been reported which have been attributed to an increased susceptibility to infection due to temporary blocking of the reticuloendothelial system. 
Zabilježena su uginuća povezana s povećanom podložnosti infekcijama uzrokovanih privremenom blokadom retikulo-endotelnog sustava.
Doses higher than 150 mg/kg/day and 667 mg/kg/day for toltrazuril and iron respectively, i.e. 3 times the highest recommended dose, have not been evaluated in the target animal safety studies. 
Doze veće od 150 mg/kg/dan i 667 mg/kg/dan za toltrazuril i željezo, tj. 3 puta veću preporučenu dozu, nisu procijenjene u ispitivanjima sigurnosti za ciljne životinje.
Injectable iron-carbohydrate complexes, such as gleptoferron, are established haematinic agents in veterinary medicine and are effective in significantly increasing the haemoglobin levels in piglets raised under intensive farming conditions in which an all milk diet for several weeks does not provide an adequate source of iron. 
Kompleks željezo-karbohidrata za primjenu u injekciji, kao što je gleptoferon, osnovni su hematološki agensi u veterinarskoj medicini i učinkoviti su u značajnom povećanju razine hemoglobina u prasadi uzgajanim u uvjetima intenzivnog uzgoja u kojem prehrana mlijekom nekoliko tjedana ne osigurava odgovarajuće količine željeza.
Muscle Skin and fat Liver Kidney 
Mišić Koža i mast Jetra Bubrezi
STATEMENT OF THE MRLs The active substances in Forceris are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: Pharmacologically active substances 
Djelatne tvari u Forcerisu su dozvoljene tvari kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
For porcine species the fat MRL relates to ‘skin and fat in natural proportions'. 
Za svinje MRL masti odnosi se na kožu i masnoću u prirodnim omjerima.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA
The “No MRL required” classification for iron dextran and iron glucoheptonate is considered to apply to gleptoferron as gleptoferron is expected to release iron dextran and iron glucoheptonate. 
Klasifikacija "Ne zahtjeva MRL" za željezo dekstran i željezo glukoheptonat nije potrebna jer se odnosi na gleptoferon koji otpušta željezo dekstran i željezo glukoheptonat.
The recommended dose is 45 mg of toltrazuril and 200 mg of iron per piglet, that is, 1.5 ml of Forceris suspension per piglet, to be administered once, in a single intramuscular injection behind the ear, between 24 and 96 hours after birth. 
Preporučena doza je 45 mg toltrazurila i 200 mg željeza po prasetu, odnosno, 1,5 ml Forceris suspenzije po prasetu koja se primjenjuje jednokratno injekcijom iza uha, u mišić, između 24 i 96 sati nakon prasenja.
During overdosage studies, a transient reduced erythrocyte count, haematocrit and hemoglobin concentration without clinical signs was observed after day 14 following single administration in the target animal safety studies at three times the highest recommended dose (mean 261 mg/piglet toltrazuril and 1156 mg/piglet iron). 
Tijekom ispitivanja predoziranja, prolazna smanjena koncentracija eritrocita, koncentracija hematokrita i hemoglobina bez kliničkih znakova uočena je nakon 14. dana nakon jednokratne primjene u ispitivanjima sigurnosti ciljnih životinja pri tri puta većoj dozi od najveće preporučene (znači 261 mg/prase toltrazurila i 1156 mg/prase željeza).
The product is recommended in piglets weighing between 0.9 and 3 kg. 
VMP se preporučuje davati prasadi mase od 0,9 do 3 kg.
Only use this veterinary medicinal product where Cystoisospora suis has been historically confirmed on a farm. 
Ovaj veterinarsko-medicinski proizvod se koristi samo ako je Cystoisospora suis prethodno potvrđena na farmi.
In case of accidental exposure to the skin or eyes, wash the affected area with water. 
U slučaju nehotičnog kontakta kože i očiju s VMP-om, odmah isperite zahvaćeno područje s vodom.
Exposure to the veterinary medicinal product may cause eye irritation or adverse effects to the skin. 
Izlaganje VMP-u može uzrokovati iritacije oka ili promjene na koži.
WITHDRAWAL PERIOD(S) Meat and offal: 70 days. 
KARENCIJA(E) Meso i jestive iznutrice: 70 dana.
Sodium chloride Docusate sodium Simethicone emulsion Silica, colloidal anhydrous Povidone 
Emulzija simetikona Silicijum-dioksid, koloidni bezvodni Povidon
After intramuscular injection of 1.5 ml/piglet of Forceris, iron is absorbed rapidly from the injection site into the capillaries and the lymphatic system and a maximal concentration of 645 µg/ml was reached after approximately 0.5 day, the AUC was about 699 day.µg/ml. 
Nakon primjene u mišić 1,5 ml/prase Forcerisa, željezo se brzo apsorbira iz mjesta ubrizgavanja u kapilare i limfni sustav, a maksimalna koncentracija od 645 µg/ml postiže se nakon približno 0,5 dana, AUC je oko 699 dana.µg/ml.
STATEMENT OF ACTIVE SUBSTANCES 1 ml contains 30 mg toltrazuril and 133 mg iron (III) (as gleptoferron) 
SASTAV DJELATNIH TVARI Jedan ml sadržava 30 mg toltrazurila i 133 mg željeza (III) (u obliku gleptoferona)
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable 
13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE,
Avoid skin and eye contact with the product. 
Treba izbjegavati kontakt VMP-a s očima i kožom.
PHARMACEUTICAL FORM Suspension for injection 
OBLIK Suspenzija za injekciju
CONTRAINDICATIONS Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium. 
KONTRAINDIKACIJE VMP se ne smije primjenjivati prasadi za koju se sumnja da pati od manjka vitamina E i/ili selena.
At 3 times the recommended dose (135 mg/piglet toltrazuril and 600 mg/piglet iron) only a slight transient reduced erythrocyte count was observed after 21 days. 
Kod primjene tri puta veće od preporučene doze (135 mg/prase toltrazurila i 600 mg/prase željeza) uočeno je samo neznatno prolazno smanjenje broja eritrocita nakon 21 dana.
For the concomitant prevention of iron deficiency anaemia and prevention of clinical signs of coccidiosis (diarrhoea) as well as reduction in oocyst excretion, in piglets in farms with a confirmed history of coccidiosis caused by Cystoisospora suis. 
Veterinarsko-medicinski proizvod se istodobno primjenjuje za sprječavanje anemije uzrokovane nedostatkom željeza u prasadi i sprječavanje kliničkih znakova kokcidioze (proljev), te umanjivanje izlučivanja oocista u prasadi na farmama u kojima se ranija javljala kokcidioza uzrokovana
After intramuscular administration of 1.5 ml/piglet of Forceris, maximal concentrations of 7 mg/l of toltrazuril were reached about 6 days after administration (Tmax ranging from 4 to 7 days), and the AUC was about 57 day.mg/l. 
Nakon primjene u mišić 1,5 ml/prase Forcerisa, maksimalne koncentracije od 7 mg l toltrazurila postiže se oko 6 dana nakon primjene (Tmax u rasponu od 4 do 7 dana), a AUC oko 57 dana.mg/l.
After intramuscular administration of 1.5 ml/piglet of Forceris the maximal concentration of 10 mg/l for toltrazuril sulfone was reached about 13 days after administration (Tmax ranging from 10 to 19 days), and the AUC was about 183 day.mg/l. 
Nakon primjene u mišić 1,5 ml/prase Forcerisa, maksimalna koncentracija od 10 mg/l za toltrazuril sulfon dosegnuta je oko 13 dana nakon primjene (Tmax u rasponu od 10 do 19 dana), a AUC je bila oko 183 dana.mg/L.
MARKETING AUTHORISATION NUMBER(S) EU/2/19/235/001-003 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/19/235/001-003
Excipients: Phenol 
Pomoćne tvari: Fenol
Box with 1 vial of 250 ml. 
Kutija s 1 bočicom od 250 ml.
It is recommended to administer the product to all the piglets in a litter. 
Preporučuje se davanje VMP-a svoj prasadi u leglu.
Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium. 
VMP se ne smije primjenjivati prasadi za koju se sumnja da pati od manjka vitamina E i/ili selena.
MARKETING AUTHORISATION NUMBER(S) EU/2/19/235/001 (100 ml) 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/19/235/001 (100 ml)
Box with 1 vial of 500 ml. 
Kutija s 1 bočicom od 500 ml.
NAME OF THE VETERINARY MEDICINAL PRODUCT Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets toltrazuril / iron (III) (as gleptoferron) 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Forceris 30 mg/ml + 133 mg/ml suspenzija za injekciju, za prasad toltrazuril / željezo (III) (u obliku gleptoferona)
NAME OF THE VETERINARY MEDICINAL PRODUCT Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Forceris 30 mg/ml + 133 mg/ml suspenzija za injekciju, za prasad
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use. 
NAČIN I PUT(EVI) PRIMJENE
Box with 1 vial of 100 ml. 
Kutija s 1 bočicom od 100 ml.
PACKAGE LEAFLET Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets 
UPUTA O VMP: Forceris 30 mg/ml + 133 mg/ml suspenzija za injekciju, za prasad
Poultry 100 
Natrijev dokuzat
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Etiketa na bočici
This product may be harmful for the unborn child. 
VMP može biti štetan za plod.
Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale 
Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet:
Intramuscular use. 
Za primjenu u mišić.
For the 250 ml and 500 ml vials, the rubber stopper may be punctured up to 20 times. 
Gumeni čep u bočica od 100 ml se ne smije probušiti više od 30 puta, a kod bočica od 250 ml i 500 ml više od 20 puta.
Muscle Fat 
Mišić Mast Jetra Bubrezi
6.4 Special precautions for storage 
11. POSEBNE MJERE PRI ČUVANJU
• Then continue with your normal schedule. 
• Zatim nastavite s uobičajenim rasporedom.
You should wash your hands immediately after opening the capsules. 
Operite ruke odmah nakon otvaranja kapsula.
You may require medical attention. 
Možda će Vam biti potrebna medicinska skrb.
If this happens, do not drive or use any tools or machines until you are feeling well again. 
Ako se to dogodi, nemojte voziti niti koristiti alate ili strojeve dok se ponovno ne počnete osjećati dobro.
Generally the reported outcome in these cases was “improved” or “recovered”. 
Općenito, zabilježeni ishod u ovim slučajevima je bio „poboljšanje“ ili „oporavak“.
However, the mechanism of the observed interaction is presently unknown. 
Međutim, mehanizam uočene interakcije trenutno nije poznat.
Take the medicine pack with you. 
Sa sobom ponesite pakiranje lijeka.
This change is not thought to be clinically significant. 
Smatra se da ta promjena nije klinički značajna.
The primary evidence of efficacy was based on objective response rates. 
Primarni dokaz djelotvornosti temeljio se na objektivnim stopama odgovora.
In 6 of these patients follow-up now exceeds 4 years. 
U 6 od tih bolesnika praćenje sada premašuje 4 godine.
Bilirubin elevation was below 3 %. 
Povišenje bilirubina bilo je ispod 3 %.
These include some types of cancer. 
One obuhvaćaju i neke vrste raka.
(Of note, out of the 411 patients, 353 were treated in an expanded access program without primary response data collected.) 
(Napomena, od 411 bolesnika, 353 je liječeno u proširenom pristupnom programu bez prikupljenih podataka o primarnom odgovoru.)
The data was similar when re-analysed to include only those patients age 55 or older. 
Podaci su bili slični kada su ponovno analizirani kako bi uključili samo one bolesnike u dobi od 55 godina ili starije.
• Do not take a double dose to make up a forgotten dose. 
• Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
These white cells usually help the body to fight infection. 
Te bijele krvne stanice obično pomažu tijelu u borbi protiv infekcije.
The remaining circulating radioactivity consisted of a number of minor metabolites. 
Preostala se cirkulirajuća radioaktivnost sastojala od određenog broja manje važnih metabolita.
Experience with doses higher than the recommended therapeutic dose is limited. 
Iskustvo s dozama višim od preporučene terapijske doze je ograničeno.
However, in these patients caution is recommended. 
Međutim, u tih bolesnika se preporučuje oprez.
The dose can be reduced if not tolerated. 
Doza se može smanjiti ako se ne podnosi.
• Swallow the capsules whole with a large glass of water. 
• Kapsule progutajte cijele s velikom čašom vode.
Your doctor may prescribe a higher or lower dose depending on how you respond to treatment. 
Liječnik Vam može propisati višu ili nižu dozu, ovisno o tome kako reagirate na liječenje.
They are usually mild to moderate. 
One su obično blage do umjerene.
Follow all your doctor's instructions carefully, even if they differ from the general information contained in this leaflet. 
Pažljivo slijedite sve upute dobivene od liječnika, čak i onda ako se razlikuju od općih informacija sadržanih u ovoj uputi.
The safety database for children with Ph+ ALL is very limited though no new safety concerns have been identified. 
Baza sigurnosnih podataka za djecu s Ph+ ALL-om vrlo je ograničena iako nisu uočena nikakva nova sigurnosna pitanja.
The liver was a target organ in rats and dogs. 
Jetra je bila ciljni organ u štakora i pasa.
These generally occur within the first several months of therapy. 
One su se obično javljale unutar prvih nekoliko mjeseci terapije.
• Difficulty in sleeping (insomnia). 
• otežano spavanje (nesanica)
• Decreased or increased skin sensitivity. 
• smanjena ili povećana osjetljivost kože
• if you have ever had or might now have a hepatitis B infection. 
• ako ste ikada imali ili možda sada imate infekciju virusom hepatitisa B.
The doctor will monitor the growth at regular visits. 
Liječnik će pratiti rast prilikom redovitih pregleda.
The adverse reactions were similar in all indications, with two exceptions. 
Kod svih indikacija nuspojave su bile slične, osim dvije iznimke.
9/l) were observed in 3.6 % and < 1 % of patients, respectively. 
9/l) zapažene su u 3,6 % odnosno <1 % bolesnika.
Currently available published data are summarised in section 5.1 but no recommendation on a posology can be made. 
Trenutačno dostupni objavljeni podaci sažeti su u dijelu 5.1, ali ne mogu se dati preporuke o doziranju.
If you think you may be allergic but are not sure, ask your doctor for advice. 
Ako mislite da biste mogli biti alergični ali niste sigurni, posavjetujte se sa svojim liječnikom.
Tell your doctor if you are using medicines that prevent the formation of blood clots. 
Obavijestite liječnika ako uzimate lijekove koji sprječavaju stvaranje krvnih ugrušaka.
GI and tumoural bleeding may be serious and sometimes fatal. 
Gastrointestinalno i tumorsko krvarenje može biti ozbiljno, a katkada i smrtonosno.
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus. 
Ako se primjenjuje tijekom trudnoće, bolesnica mora biti informirana o potencijalnom riziku za fetus.
Imatinib administration to patients without the genetic translocation generally results in no improvement. 
Primjena imatiniba bolesnicima bez genetske translokacije obično ne rezultira poboljšanjem.
• Rapid weight gain. 
• brzo dobivanje na težini.
Do not open or crush the capsules unless you have difficulty in swallowing (e.g. in children). 
Kapsule nemojte otvarati niti drobiti, osim ako ih ne možete progutati (npr. kod djece).
Study AAU02 
Studija AAU02
You will also have blood tests and be weighed regularly. 
Također ćete redovito provoditi krvne pretrage i mjeriti tjelesnu težinu.
If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away. 
Ako niste u mogućnosti uzimati ovaj lijek kako Vam je liječnik propisao ili ako osjećate da Vam više ne treba, odmah se obratite svom liječniku.
The rate of haematological response was 70 % with a duration of 2-3 months. 
Stopa hematološkog odgovora bila je 70 % uz trajanje od 2 do 3 mjeseca.
Leukaemia is a cancer of white blood cells. 
Leukemija je rak bijelih krvnih stanica.
This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications. 
To uključuje spontano prijavljivanje nuspojava, kao i ozbiljne štetne događaje iz trenutno provođenih ispitivanja, proširenih pristupnih programa za bolesnike, kliničkih farmakoloških studija i eksplorativnih studija u neodobrenim indikacijama.
Mean absolute bioavailability for imatinib is 98 %. 
Srednja apsolutna bioraspoloživost za imatinib iznosi 98 %.
Treatment should be continued as long as the patient continues to benefit. 
Liječenje treba nastaviti dokle god bolesnik ima korist od liječenja.
Cytogenetic abnormalities were evaluated in 117 of the total population of 176 patients. 
Citogenetske abnormalnosti su procijenjene u 117 od ukupne populacije od 176 bolesnika.
There is no experience with the treatment of children below 2 years of age. 
Ne postoji iskustvo s liječenjem djece mlađe od 2 godine.
Tell your doctor straight away if you get any of the following: 
Odmah obavijestite liječnika ako se kod Vas javi bilo što od sljedećeg: