natgillin/translations-raw huggingface dataset:
In the pivotal European multicenter 64-week clinical trial including 12 week randomised, doubleblind, double-dummy, 2-arm, parallel study period, 248 high vascular risk patients with mixed dyslipidaemia were randomised to one of the two treatment groups: Pravafenix 40 mg/160 mg or pravastatin 40 mg. Only patients who had not met their NCEP ATP III target LDL-C and Triglyceride goals (LDL >100 mg/dl and TG >150 mg/dl) after 8 weeks on pravastatin 40 mg (1 tablet, once daily) were randomized. 
12-tjedno randomizirano, dvostruko slijepo, dvostrukim placebom kontrolirano, paralelno ispitivanje 2 ispitnih skupina, 248 bolesnika s visokim vaskularnim rizikom s miješanom dislipidemijom bilo je randomizirano u jednu ili dvije liječene skupine: skupinu koja je primala Pravafenix 40 mg/160 mg ili skupinu koja je primala pravastatin 40 mg.
In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4,900 patients] versus fenofibrate 1.4% [67/4,895 patients]; p = 0.074). 
U istom ispitivanju prijavljeno je statistički značajno povećanje incidencije plućne embolije (0,7% u placebo skupini naspram 1,1% u skupini na fenofibratu; p=0,022) i statistički neznačajno povećanje duboke venske tromboze (placebo: 1,0%
There are no data from the combined use of pravastatin and fenofibrate in pregnant women. 
Pravafenix Nema podataka o kombiniranoj primjeni pravastatina i fenofibrata u trudnica.
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava snižen hemoglobin, smanjen broj leukocita
Hs-CRP (mg/L) a Number of patients b Mean percent change (least square mean ± standard error) between baseline measured after 8 weeks on Pravastatin 40 mg and 12 additional weeks with Pravafenix 40 mg/160 mg or Pravastatin 40 mg c Pairwise p-value is significant if <0.05 
između početnih vrijednosti izmjerenih nakon 8 tjedana na Pravastatinu 40 mg i 12 dodatnih tjedana primjene Pravafenixa 40 mg/160 mg ili Pravastatina 40 mg c p-vrijednost parnog testa je značajna ako je <0,05
Clinically important elevation (CK ≥ 10 times the ULN without muscular symptoms) was seen in 0.06% of the patients treated with Pravafenix. 
Klinički značajno povišenje kreatin fosfokinaze (KF ≥ 10 puta GGN bez mišićnih simptoma) viđeno je kod 0,06% bolesnika liječenih Pravafenixom. (vidjeti dio 4.4).
How to take pravafenix 
Kako uzimati Pravafenix
Adverse reaction (Pravastatin) 
Nuspojava (pravastatin)
Clinically important elevations in serum transaminases (ALT and/or AST ≥ 5 times the ULN) were seen in 0.38% of the patients treated with Pravafenix. 
Klinički značajno povišenje transaminaza u serumu (ALT i/ili AST ≥ 5 puta GGN) viđen je kod 0,38% bolesnika liječenih
Reproductive system and breast disorders 
Poremećaji reproduktivnog sustava i dojki seksualna disfunkcija seksualna disfunkcija
bladder problems (painful or frequent urination, having to pass water at night), sexual dysfunction. 
• Problemi s bubrezima (povišene ili snižene razine određenih enzima unutar tijela u krvnim nalazima), problemi s mokraćnim mjehurom (bolno ili učestalo mokrenje, potreba za mokrenjem noću), poremećaj seksualne funkcije.
EU/1/11/679/004 30 hard capsules 
EU/1/11/679/004 30 tvrdih kapsula
• The other ingredients are: - capsule content: lactose monohydrate, cellulose microcrystalline, ascorbyl palmitate, povidone, sodium starch glycolate, magnesium stearate, talc, triacetin, sodium hydrogen carbonate, lauroyl macrogolglycerides, hydroxypropylcellulose, macrogol 20 000. 
• Pomoćne tvari su: - sadržaj kapsule: laktoza hidrat, mikrokristalična celuloza, askorbilpalmitat, povidon,
(eructation)). 
žučne kolike itd.).
Common side effects (may affect up to 1 in 10 people) 
Druge nuspojave Česte nuspojave (mogu se javiti kod manje od 1 od 10 osoba)
Muscle disorder (e.g. myositis, muscular weakness) 
Poremećaji mišićno koštanog sustava i vezivnog tkiva poremećaji mišića (npr. miozitis, mišićna slabost)
If you get any side effects, talk to your doctor or pharmacist. 
Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/007 14 hard capsules 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/679/007 14 tvrdih kapsula
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg of pravastatin sodium and 160 mg of fenofibrate. 
NAVOĐENJE DJELATNE(IH) TVARI Svaka kapsula sadrži 40 mg pravastatinnatrija i 160 mg fenofibrata.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001 30 hard capsules 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/679/001 30 tvrdih kapsula
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/005 60 hard capsules 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/679/005 60 tvrdih kapsula
Respiratory, thoracic and mediastinal disorders 
prsišta i sredoprsja intersticijska pneumopatija
Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL-C when LDL-C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy. 
smanjenje tjelesne težine), za liječenje mješovite hiperlipidemije u odraslih bolesnika s visokim kardiovaskularnim rizikom s ciljem smanjenja triglicerida i povećanja kolesterola visoke gustoće
Pravafenix is bioequivalent to coadministered fenofibrate and pravastatin in a single dose study. 
U ispitivanju jednokratne doze Pravafenix je bioekvivalentan istodobno primijenjenom fenofibratu i pravastatinu.
- You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain) - You are pregnant or breast-feeding. 
- ako bolujete od bolesti žučnog mjehura, - ako bolujete od pankreatitisa (upale gušterače koja dovodi do boli u trbuhu),
Blood cholesterol increased, blood triglycerides increased, lowdensity lipoprotein increased, weight increased. 
Pretrage povišenje kolesterola u krvi, povišenje triglicerida u krvi,
EU/1/11/679/002 60 hard capsules 
EU/1/11/679/002 60 tvrdih kapsula
Laboratoires SMB S.A. Tlf: + 32.2.411.48.28. 
Tlf: + 32.2.411.48.28.
Tel: +40 21 211 71 83 
Solartium Group S.r.l. Tel: +40 21 211 71 83
Receptor type α (PPARα). 
PPARα receptora.
The following adverse events have been reported with some statins: - Nightmares - Memory loss - Depression - Exceptional cases of interstitial lung disease, especially with long term therapy (see section 4.4). 
Prijavljene su sljedeće nuspojave s nekim statinima: - noćne more - gubitak pamćenja
EU/1/11/679/006 90 hard capsules 
EU/1/11/679/006 90 tvrdih kapsula
Blood creatinine increased, creatinine renal clearance decreased, creatinine renal clearance increased, Renal failure 
Poremećaji bubrega i mokraćnog sustava povišen kreatinin u krvi, snižen bubrežni klirens kreatinina, povišen bubrežni klirens kreatinina, zatajenje bubrega
• Digestive effects: gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence, constipation, dry mouth, upper abdominal pain with bloating (dyspepsia), burping 
• Učinci na probavni sustav: želučani ili crijevni poremećaji (bol u trbuhu, mučnina, povraćanje,
NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate 
UPUTA O LIJEKU: PODACI ZA OSOBE Pravafenix 40 mg/160 mg tvrde kapsule pravastatin/fenofibrat
Suomi/Finland Laboratoires SMB S.A. Puh/Tel: + 32.2.411.48.28. 
Puh/Tel: + 32.2.411.48.28.
EU/1/11/679/003 90 hard capsules 
EU/1/11/679/003 90 tvrdih kapsula
EXP 
SEb
Dizziness, headache, paraesthesia 
Poremećaji živčanog sustava omaglica, glavobolja, parestezija
Rare side effects (may affect up to 1 in 1,000 people) • Decrease in haemoglobin (oxygen-carrying pigment in blood) and leukocytes (white blood cells). 
• Snjiženje hemoglobina (krvnog pigmenta zaduženog za prijenos kisika) i leukocita (bijelih krvnih stanica).
No posology adjustment is required in patients with mild hepatic impairment. 
Kod bolesnika s blagim oštećenjem jetre nije potrebna prilagodba doziranja.
Investigation 
Doziranje
In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. 
U bolesnika u kojih je primjena sistemske fusidatne kiseline smatra neophodnom,
and/or AST ≥ 3 times the ULN, < 5 times the ULN) was 0.83% for patients treated with Pravafenix. 
U kliničkim ispitivanjima incidencija značajnih povišenja transaminaza u serumu (ALT i/ili AST ≥ 3 puta GGN, < 5 puta GGN) bila su kod 0,83% bolesnika liječenih Pravafenixom.
If you take more Pravafenix than you should Please contact your doctor or pharmacist 
Ako uzmete više Pravafenixa nego što ste trebali
Intersticial pneumopathies 
Synapsis Trading Limited
Oreškovićeva 6H, 10010 Zagreb, 
Oreškovićeva 6H, 10010 Zagreb, Croatia
56 Eirinis Ave., 151 21, Pefki, 
151 21, Pefki,
92787 ISSY-LESMOULINEAUX Cedex 9 France 
92787 ISSY-LES-MOULINEAUX Cedex
JANSSEN-CILAG 1, rue Camille Desmoulins TSA 91003 
1, rue Camille Desmoulins TSA 91003
JANSSEN-CILAG GmbH Johnson & Johnson Platz 1 41470 Neuss, Germany 
GmbH Johnson & Johnson Platz 1 41470 Neuss, Germany
Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00 
Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00
Luxembourg Janssen-Cilag N.V. Antwerpseweg 15-17 
Luksemburg Janssen-Cilag N.V. Antwerpseweg 15-17
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES 
POPIS NAZIVA, FARMACEUTSKOG OBLIKA, JAČINE LIJEKA, PUTA PRIMJENE,
Šmartinska cesta 53, 1000 Ljubljana Slovenia 
Johnson & Johnson d.o.o. Šmartinska cesta 53, 1000 Ljubljana Slovenia
Janssen-Cilag Pharmaceutical S.A.C.I. 
Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave.,
Belgium Janssen-Cilag N.V. Antwerpseweg 15-17 
Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium
Durogesic 12 mikrogramm/óra transzdermális tapasz 
Durogesic 12 mikrogramm/ór a transzdermális tapasz
Durogesic 12 microgrammes/h eure, dispositif transdermique 
Durogesic 12 microgrammes/ heure, dispositif transdermique
Durogesic 100 microgrammes/h eure, dispositif transdermique 
Durogesic 100 microgrammes/ heure, dispositif transdermique
Durogesic 100 mikrogramm/óra transzdermális tapasz 
Durogesic 100 mikrogramm/ór a transzdermális tapasz
JANSSEN-CILAG SpA Via M. Buonarroti, 23 
Buonarroti, 23
Durogesic 75 mikrogramm/óra transzdermális tapasz 
Durogesic 75 mikrogramm/ór a transzdermális tapasz
Durogesic 25 mikrogramm/óra transzdermális tapasz 
Durogesic 25 mikrogramm/ór a transzdermális tapasz
Durogesic 75 microgrammes/h eure, dispositif transdermique 
Durogesic 75 microgrammes/ heure, dispositif transdermique
Durogesic 50 mikrogramm/óra transzdermális tapasz 
Durogesic 50 mikrogramm/ór a transzdermális tapasz
Durogesic 50 microgrammes/h eure, dispositif transdermique 
Durogesic 50 microgrammes/ heure, dispositif transdermique
Durogesic 25 microgrammes/h eure, dispositif transdermique 
Durogesic 25 microgrammes/ heure, dispositif transdermique
d.o.o. 
SpA Via M.
This summary was last updated in July 2015. 
Ovaj sažetak je posljednji put ažuriran u srpnju 2015.
Fortekor Plus is given twice daily approximately one hour before feeding. 
Fortekor Plus primjenjuje se dvaput dnevno otprilike jedan sat prije unosa hrane.
The full EPAR for Fortekor Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Plus nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Fortekor Plus on 8 September 2015. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Fortekor Plus na snazi u Europskoj uniji od 8. rujna 2015.
The dose is adjusted according to bodyweight. 
Doza se prilagođava tjelesnoj težini.
When the production of angiotensin II is lowered, the blood vessels relax and widen. 
Kada se proizvodnja angiotenzina II smanji, krvne žile se opuštaju i šire.
Pimobendan/benazepril hydrochloride 
Pimobendan/benazepril hidroklorid
Why is Fortekor Plus approved? 
Zašto je Fortekor Plus odobren?
Fortekor Plus is available as tablets (pimobendan 1.25 mg/benazepril hydrochloride 2.5 mg and pimobendan 5 mg/benazepril hydrochloride 10 mg) and can only be obtained with a prescription. 
Plus je dostupan kao tablete (pimobendan 1,25 mg/benazepril hidroklorid 2,5 mg i pimobendan 5 mg/benazepril hidroklorid 10 mg) te se izdaje samo na liječnički recept.
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. 
Objašnjava kako je Agencija ocijenila ovaj VMP da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
What is Fortekor Plus and what is it used for? 
Što je Fortekor Plus i za što se koristi?
Congestive heart failure is a condition where the heart cannot pump enough blood around the body. 
Kongestivno zatajenje srca je stanje kod kojeg srce ne može istisnuti dovoljnu količinu krvi kroz tijelo.
The most common side effects with benazepril are short-lived episodes of vomiting, incoordination or signs of tiredness. 
Najčešće nuspojave benazeprila kratke su epizode povraćanja, nekoordinacije ili znakova umora.
People who are hypersensitive (allergic) to pimobendan or benazepril hydrochloride should avoid contact with Fortekor Plus. 
Osobe koje su preosjetljive (alergične) na pimobendan ili benazepril hidroklorid trebaju izbjegavati kontakt s VMP-om Fortekor Plus.
Fortekor Plus is a veterinary medicine used to treat congestive heart failure in dogs. 
Plus je veterinarsko-medicinski proizvod koji se koristi za liječenje kongestivnog zatajenja srca u pasa.
The most common side effects with pimobendan (which may affect more than 1 in 10,000 dogs) are an increase in heart rate and vomiting. 
Najčešće nuspojave pimobendana (koje se mogu javiti u više od 1 na 10.000 pasa) povećanje su srčane frekvencije i povraćanje.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) decided that Fortekor Plus' benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Fortekor Plus nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels). 
ACE inhibitori smanjuju proizvodnju angiotenzina II, snažnog vazokonstriktora (tvari koja suzuje krvne žile).
The main measure of effectiveness was the total score of exercise intolerance, demeanour, breathing effort, coughing and difficulty of breathing at night. 
Glavna mjera djelotvornosti bio je ukupan rezultat u pogledu intolerancije na tjelesnu aktivnost, ponašanja, napora pri disanju, kašljanja i otežanog disanja tijekom noći.
It is not intended to provide practical advice on how to use Fortekor Plus. 
Svrha sažetka nije davati praktične savjete o primjeni VMP-a Fortekor Plus.
If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor. 
U slučaju nehotičnog gutanja ovog proizvoda treba smjesta potražiti savjet liječnika te mu pokazati uputu o VMP-u ili etiketu proizvoda.
Benazepril is a prodrug, a substance that is converted to benazeprilat in the body. 
Benazepril je prolijek, tvar koja se pretvara u benazeprilat u tijelu.
Fortekor Plus must not be given to dogs with hypertrophic cardiomyopathy (heart muscle disease where the walls of the heart thicken reducing blood output), clinical conditions where heart output cannot increase because of functional or anatomical reasons (e.g. narrowing of the aorta or pulmonary artery). 
Fortekor Plus ne smije se primjenjivati u pasa s hipertrofičnom kardiomiopatijom (oboljenjem srčanog mišića uslijed kojeg dolazi do zadebljanja stjenki srca što smanjuje protok krvi), kliničkim stanjima kod kojih nije moguće povećanje istisne funkcije srca zbog funkcionalnih ili anatomskih razloga (primjerice, stenoze aorte ili plućne arterije).
Fortekor Plus contains two active substances, pimobendan and benazepril hydrochloride. 
Fortekor Plus sadrži dvije djelatne tvari, pimobendan i benazepril hidroklorid.
This is a summary of the European public assessment report (EPAR) for Fortekor Plus. 
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda Fortekor Plus.
Both pimobendan and benazepril are already authorised for dogs as separate medicines. 
Pimobendan i benazepril već su odobreni za primjenu u pasa kao zasebni veterinarsko-medicinski proizvodi.
Pimobendan is an inotropic (heart stimulant) substance which increases the strength of the contraction of heart muscle and opens up blood vessels carrying blood to and from the heart, which reduces the work of the heart. 
Pimobendan je inotropna tvar (srčani stimulans) koja povećava jačinu kontrakcije srčanog mišića i otvara krvne žile koje prenose krv u srce i iz njega, čime se smanjuje rad srca.
Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'. 
Benazeprilat je „inhibitor enzima koji konvertiraju angiotenzin (ACE)”.
It is only for use in dogs whose heart failure is already being controlled by the same doses of pimobendan and benazepril hydrochloride given as separate medicines. 
Koristi se samo za primjenu u pasa čije se zatajenje srca već kontrolira istim dozama pimobendana i benazepril hidroklorida koji se uzimaju zasebno.
For more information about treatment with Fortekor Plus, read the package leaflet (also part of the EPAR) or contact your veterinarian or pharmacist. 
Više informacija o terapiji VMP-om Fortekor Plus pročitajte u uputi o VMP-u (također dio EPAR-a), ili se obratite svom veterinaru ili ljekarniku.
What are the risks associated with Fortekor Plus? 
Koji su rizici povezani s veterinarsko-medicinskim proizvodom Fortekor Plus?
For the full list of all restrictions and side effects reported with Fortekor Plus, see the package leaflet. 
Potpuni popis svih ograničenja i nuspojava zabilježenih pri primjeni VMP-a Fortekor Plus potražite u uputi o lijeku.
How is Fortekor Plus used? 
Kako se Fortekor Plus koristi?
In a field study involving 67 dogs with congestive heart failure treatment with Fortekor Plus was compared to pimobendan and benazepril given as separate treatments. 
U terenskom ispitivanju kojim je obuhvaćeno 67 pasa s kongestivnim zatajenjem srca terapija VMP-om Fortekor Plus uspoređena je sa zasebnim terapijama pimobendanom i benazeprilom.
The study showed Fortekor Plus to be as effective as pimobendan and benazepril when given as separate treatments. 
U ispitivanju se pokazalo da je VMP Fortekor Plus podjednako djelotvoran kao pimobendan i benazepril kada ih se uzima kao zasebne terapije.
This allows the blood pressure to drop, reducing the load on the heart. 
Time se stvara manje opterećenje na srce, što dovodi do smanjenja krvnog tlaka.
For practical information about using Fortekor Plus, animal owners/keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Praktične informacije o primjeni VMP-a Fortekor Plus vlasnici životinja/uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svom veterinaru ili ljekarniku.
It also must not be given to dogs with low blood pressure, low blood volume, low blood sodium levels or acute (short-term) kidney failure. 
Također se ne smije primjenjivati u pasa s hipotenzijom, hipovolemijom, hiponatrijemijom ili akutnim (kratkoročnim) zatajenjem bubrega.
Other information about Fortekor Plus 
Ostale informacije o veterinarsko-medicinskom proizvodu Fortekor Plus
Safety information has been included in the summary of product characteristics and the package leaflet for Fortekor Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners/keepers. 
U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Fortekor Plus nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja/uzgajivači trebaju pridržavati.
Pregnant women should take special care to avoid accidentally swallowing Fortekor Plus because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy. 
Plus jer je otkriveno da inhibitori enzima koji konvertiraju angiotenzin (ACE) utječu na nerođeno dijete tijekom trudnoće.
How does Fortekor Plus work? 
Kako djeluje Fortekor Plus?
What benefits of Fortekor Plus have been shown in studies? 
Koje su koristi veterinarsko-medicinskog proizvoda Fortekor Plus utvrđene u ispitivanjima?
2 x 5 pre-filled syringes without safety device 
Put primjene Unutarnje pakiranje
Further information on Grasustek can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/grasustek. 
Više informacija o lijeku Grasustek dostupno je internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/grasustek.
What is Grasustek and what is it used for? 
Što je Grasustek i za što se koristi?
Severe neutropenia lasted just over one-and-a-half days on average with both medicines. 
Teška neutropenija trajala je u prosjeku malo dulje od 1,5 dana pri primjeni oba lijeka.
What measures are being taken to ensure the safe and effective use of Grasustek? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Grasustek?
This means that Grasustek is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To znači da je Grasustek vrlo sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
Grasustek is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of cancer treatment. 
Lijek Grasustek daje se kao jedna doza od 6 mg koja se ubrizgava pod kožu najmanje 24 sata nakon završetka svakog ciklusa liječenja raka.
The most common side effect with Grasustek (which may affect more than 1 in 10 people) is pain in the bones. 
Najčešća nuspojava lijeka Grasustek (koja se može javiti u više od 1 na 10 osoba) jest bol u kostima.
Why is Grasustek authorised in the EU? 
Zašto je lijek Grasustek odobren u EU-u?
What are the risks associated with Grasustek? 
Koji su rizici povezani s lijekom Grasustek?
An overview of Grasustek and why it is authorised in the EU 
Pregled informacija o lijeku Grasustek i zašto je odobren u EU-u
Grasustek is a ‘biosimilar medicine'. 
Grasustek je „biosličan lijek”.
Grasustek can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders. 
Lijek Grasustek izdaje se samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju raka ili poremećaja krvi.
Side effects reported with Grasustek are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Grasustek pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
The reference medicine for Grasustek is Neulasta. 
Referentni lijek za Grasustek jest Neulasta.
Other information about Grasustek 
Ostale informacije o lijeku Grasustek
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grasustek has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. 
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, utvrđeno da lijek Grasustek ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Neulasta te se u tijelu raspoređuje na isti način.