natgillin/translations-raw huggingface dataset:
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen. 
Za sekundarni studijski ishod fatalnih i nefatalnih kardiovaskularnih događaja, u sveukupnoj ispitivanoj populaciji nije bilo razlika između tri skupine, iako je zabilježena povećana incidencija nefatalnog infarkta miokarda u žena i smanjena incidencija nefatalnog infarkta miokarda u muškaraca u skupini koja je primala irbesartan u odnosu na onu koja je primala placebo.
Pharmathen S.A, 6 Dervenakion Str., 15351 Pallini, Attiki, Greece 
Pharmathen S.A, 6 Dervenakion Str., 15351 Pallini, Attiki, Grčka
PSURs 
PSURevi
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started. 
Ako se utvrdi trudnoća, mora se odmah prekinuti terapija antagonistima receptora angiotenzina II te treba, ako je to primjereno, uvesti drugu terapiju.
tinnitus 
Tinitus
The dose may later be increased to 300 mg once daily 
Doza se kasnije može povećati na 300 mg jednom na dan, ovisno o vrijednostima krvnog tlaka.
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). 
Tablete treba progutati s dovoljnom količinom tekućine
5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. 
hiperkalijemija (≥ 5,5 mEq/L) se razvila kod 29,4% bolesnika koji su primali 300 mg irbesartana i kod 22% bolesnika u placebo skupini.
• Uncommon : heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. 
• Manje često: ubrzani srčani ritam, crvenilo praćeno osjećajem vrućine, kašalj, proljev, probavni poremećaji/žgaravica, problemi sa seksualnom funkcijom, bol u prsištu.
diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg. 
Bolesnici u svim liječenim skupinama obično su uzimali između 2 i 4 antihipertenzivna lijeka (npr. diuretike, beta blokatore, alfa blokatore) kako bi postigli unaprijed definirani krvni tlak od ≤ 135/85 mmHg ili smanjenje sistoličkog tlaka za 10 mmHg ako je početna vrijednost bila > 160 mmHg.
vertigo, headache Ear and labyrinth disorder: Not known: 
Poremećaji uha i labirinta:
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. 
Osim ako se nastavak terapije antagonistima receptora angiotenzina II ne smatra neophodnim, bolesnice koje planiraju trudnoću trebaju prijeći na drugu antihipertenzivnu terapiju s potvrđenom sigurnošću primjene u trudnoći.
Potassium supplements and potassium-sp aring diuretics: based on experience with the use of other medicinal products that affect the reninangiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4). 
Nadomjesci kalija i diuretici koji štede kalij: na temelju iskustva s ostalim lijekovima koji utječu na reninangiotenzinski sustav, istodobno uzimanje diuretika koji štede kalij, nadomjestaka kalija, nadomjestaka soli koji sadrže kalij ili ostalih lijekova koji mogu povećati serumsku razinu kalija (npr. heparin) može izazvati porast serumskog kalija te se stoga ne preporučuje (vidjeti dio 4.4).
In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed. 
Smanjenje razine hemoglobina*, koje nije bilo klinički značajno, zabilježeno je u 1,7% hipertenzivnih bolesnika s uznapredovalom dijabetičkom bubrežnom bolesti koji su primali irbesartan.
hypersensitivity reactions such as angioedema, rash, urticaria Metabolism and nutrition disorders: 
Reakcije preosjetljivosti kao što su angioedem, osip i urtikarija
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Silica colloidal anhydrous Hypromellose Magnesium stearate. 
Jezgra tablete: laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni bezvodni hipromeloza magnezijev stearat
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4). 
Nadomjestci kalija i diuretici koji štede kalij: na temelju iskustva s ostalim lijekovima koji utječu na renin angiotenzinski sustav, istodobno uzimanje diuretika koji štede kalij, nadomjestaka kalija, nadomjestaka soli koji sadrže kalij ili ostalih lijekova koji mogu povećati serumsku razinu kalija (npr. heparin) može izazvati porast serumskog kalija te se stoga ne preporučuje (vidjeti dio 4.4.).
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6). 
te treba, ako je to primjereno, započeti s drugom terapijom (vidjeti dijelove 4.3 i 4.6).
Sabervel 300mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets. 
Sabervel 300 mg filmom obložene tablete dostupne su u blister pakiranjima od 28, 56, 90 ili 98 filmom obloženih tableta.
White, concave, round, film-coated tablet with 7 mm diameter. 
Bijela, konkavna, okrugla, filmom obložena tableta promjera 7 mm
Musculoskeletal and connective tissue disorders: Common: 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva:
impaired renal function including cases of renal failure in patients at risk (see section 4.4) 
Poremećaji bubrega i mokraćnog sustava: Oštećena funkcija bubrega, uključujući slučajeve zatajenja bubrega u rizičnoj skupini bolesnika (vidjeti dio 4.4).
Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). 
II receptora ili aliskirena stoga se ne preporučuje (vidjeti dijelove 4.5 i 5.1).
Sabervel 75mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets. 
Sabervel 75 mg filmom obložene tablete dostupne su u blister pakiranjima od 28, 56, 90, ili 98 filmom obloženih tableta.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 
U bolesnika sa šećernom bolesti i hipertenzijom, mikroalbuminurijom i normalnom bubrežnom funkcijom,
White, concave, round, film-coated tablet with 11 mm diameter. 
Bijela, konkavna, okrugla filmom obložena tableta promjera 11 mm.
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo. 
do 300 mg jedanput na dan smanjuju krvni tlak u ležećem ili sjedećem položaju u vrijeme najniže koncentracije u krvi (to jest 24 sata nakon uzimanja doze) i to u prosjeku za 8-13/5-8 mm Hg
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
Uzimanje antagonista receptora angiotenzina II ne preporučuje se tijekom prvog tromjesečja trudnoće (vidjeti dio 4.4), a kontraindicirana je tijekom drugog i trećeg tromjesečja (vidjeti dijelove 4.3 i 4.4).
The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline). 
(brzina izlučivanja albumina u mokraću (engl. urinary albumin excretion rate, UAER) >300 mg/dan i porast u vrijednostima UAER najmanje 30% od početnih vrijednosti).
Sabervel 150mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets. 
Sabervel 150 mg filmom obložene tablete dostupne su u blister pakiranjima od 28, 56, 90 ili 98 filmom obloženih tableta.
• Patients with high blood pressure The usual dose is 150 mg once a day. 
Uobičajena doza iznosi 150 mg jednom na dan.
(It is also better to avoid Sabervel in early pregnancy 
Sabervel se ne preporučuje uzimati u ranoj trudnoći.
NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets 
NAZIV GOTOVOG LIJEKA Sabervel 75 mg filmom obložene tablete
Luxe mbourg/Luxemburg Portfarma ehf. 
Luxe mbourg/Luxe mburg Portfarma ehf.
What Sabervel looks like and contents of the pack Sabervel 75 mg film-coated tablets are white, concave, round, film-coated tablets with 7 mm diameter. 
Sabervel 75 mg filmom obložene tablete su bijele, konkavne, okrugle filmom obložene tablete promjera 7 mm
Pharmathen S.A. 6 Dervenakion str. 15351 Pallini Attiki Greece 
Pharmathen S.A. 6, Dervenakion str., 153 51 Pallini Attiki, Grčka
The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more 
Učestalost nuspojava u nastavku teksta definira se na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 75 mg irbesartan 
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Jedna tableta sadrži 75 mg irbesartana
NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets irbesartan 
NAZIV GOTOVOG LIJEKA Sabervel 75 mg filmom obložene tablete irbesartan
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, hypromellose, magnesium stearate, Film-coating: hypromellose, titanium dioxide (E171), macrogol 400 
• Jezgra tablete: laktoza hidrat, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid, hipromeloza , magnezijev stearat.
The study of the “Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 
Klinička studija «Ispitivanje irbesartana u bolesnika s dijabetičkom nefropatijom« (Irbesartan Diabetic
Hypromellose 
Hiperkalijemija
White, concave, round, film-coated tablet with 9 mm diameter. 
Bijela, konkavna, okrugla filmom obložena tableta promjera 9 mm
Respiratory, thoracic and mediastinal disorders: Uncommon: 
Poremećaji dišnog sustava, prsišta i sredoprsja: Manje često:
Hypertension and type 2 diabetes with renal disease The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria. 
Nephropathy Trial, IDNT) pokazuje da irbesartan smanjuje progresiju bubrežne bolesti u bolesnika s kroničnom bubrežnom insuficijencijom i manifestnom proteinurijom.
jaundice 
kašalj
What Sabervel looks like and contents of the pack Sabervel 150 mg film-coated tablets are white, concave, round, film-coated tablets with 9 mm diameter. 
Sabervel 150 mg filmom obložene tablete su bijele, konkavne, okrugle filmom obložene tablete promjera 9 mm
tachycardia Vascular disorders: 
Poremećaji probavnog sustava: Dizgeuzija
• to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory 
• liječenje visokog krvnog tlaka (esencijalne hipertenzije) • zaštitu bubrega u bolesnika sa šećernom bolesti tipa 2 koji imaju povišeni krvni tlak i laboratorijski dokazanu oslabljenu bubrežnu funkciju.
NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets irbesartan 
NAZIV GOTOVOG LIJEKA Sabervel 300 mg filmom obložene tablete irbesartan
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan Excipient with known effect: 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 300 mg irbesartana
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan Excipient with known effect: 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 150 mg irbesartana
NAME OF THE MEDICINAL PRODUCT Sabervel 150 mg film-coated tablets irbesartan 
NAZIV GOTOVOG LIJEKA Sabervel 150 mg filmom obložene tablete irbesartan
NAME OF THE MEDICINAL PRODUCT Sabervel 150 mg film-coated tablets 
NAZIV GOTOVOG LIJEKA Sabervel 150 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets 
NAZIV GOTOVOG LIJEKA Sabervel 300 mg filmom obložene tablete
România Pharmathen S.A. 
Slovenská republika Pharmathen S.A.
The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive. 
Ibesartan i tiazidski diuretici imaju aditivan učinak na sniženje krvnog tlaka.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan Excipient with known effect: 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 75 mg irbesartana 20mg laktoze hidrat u jednoj filmom obloženoj tableti
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, 
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze,
NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A. 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pharmathen S.A. ROK VALJANOSTI Rok valjanosti
Adverse reactions additionally reported from post-marketing experience are also listed. 
Sljedeće dodatne nuspojave prijavljene su nakon stavljanja lijeka u promet; te nuspojave proizlaze iz spontanog prijavljivanja te stoga njihova učestalost nije poznata.
Skin and subcutaneous tissue disorders: Not known: 
Poremećaji kože i potkožnog tkiva: Leukocitoklastični vaskulitis
Tell your doctor if you are breast-feeding or about to start breast-feeding. 
Ako dojite ili trebate početi s dojenjem obavijestite svog liječnika.
hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group. 
se razvila u 46,3% bolesnika koji su primali irbesartan te u 26,3% bolesnika u placebo skupini.
40 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1. 
40 mg laktoze hidrat u jednoj filmom obloženoj tableti
80 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1. 
80 mg laktoze hidrat u jednoj filmom obloženoj tableti
Sabervel is used in adult patients 
Sabervel se primjenjuje za
Gastrointestinal disorders: Common: 
Poremećaji probavnog sustava: Disgeuzija
After either oral or IV administration of 
Nakon oralne ili i.v. primjene 14C
It contains the active substance filgrastim (30 or 48 million units). 
Sadrži djelatnu tvar filgrastim (30 ili 48 milijuna jedinica).
The full EPAR for Filgrastim Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za Filgrastim Hexal nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure in these studies was the neutrophil count over the first 10 days of treatment. 
Glava mjera u tim ispitivanjima bio je broj neutrofila tijekom prvih 10 dana liječenja.
Filgrastim is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce filgrastim. 
Filgrastim se proizvodi metodom „tehnologije rekombinantne DNK“: proizvodi se od bakterije u koju je ugrađen gen (DNK) koji omogućava stvaranje filgrastima.
The replacement acts in the same way as naturally produced G CSF by encouraging the bone marrow to produce more white blood cells. 
Ta zamjena djeluje na isti način kao i prirodno stvoren G-CSF tako što potiče koštanu srž na stvaranje većeg broja bijelih krvnih stanica.
How it is given, the dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment. 
Način primjene, doziranje i trajanje liječenja ovise o svrsi primjene, tjelesnoj težini bolesnika i reakciji na liječenje.
The studies looked at the effects of single and repeated administration of various doses of the medicines, either injected under the skin or infused into a vein. 
Ispitivanja su istražila učinke jednokratnog i ponovljenog uzimanja različitih doza lijekova, injekcijom pod kožu ili infuzijom u venu.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Filgrastim Hexal. 
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje za izdavanje odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za uporabu za lijek Filgrastim Hexal.
The most common side effect with Filgrastim Hexal (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). 
Najčešće nuspojave lijeka Filgrastim Hexal (koje se mogu javiti u više od 1 na 10 osoba) su mišićnokoštana bol (bol u mišićima i kostima).
Filgrastim Hexal is used to stimulate the production of white blood cells in the following situations: 
Filgrastim Hexal se koristi za stimulaciju proizvodnje leukocita u sljedećim situacijama:
Filgrastim Hexal is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately. 
Filgrastim Hexal se obično daje u specijaliziranim centrima za liječenje, ali bolesnici koji taj lijek primaju potkožnom injekcijom mogu ga ubrizgavati i sami po završetku odgovarajuće obuke.
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim Hexal is being used for. 
Druge nuspojave mogu se javiti u više od 1 na 10 osoba, ovisno o stanju za koje se Filgrastim Hexal primjenjuje.
Four studies looked at the levels of neutrophils in the blood in a total of 146 healthy volunteers who received Filgrastim Hexal or Neupogen. 
Četiri ispitivanja istražila su razine neutrofila u krvi 146 zdrava dobrovoljca koji su primali Filgrastim Hexal ili Neupogen.
For more information about treatment with Filgrastim Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o terapciji lijekom Filgrastim Hexal pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
• to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections; 
• za povećanje broja neutrofila i smanjenje rizika povezanih s infekcijom u bolesnika s neutropenijom koji imaju povijest ozbiljnih, repetitivnih infekcija;
This is a summary of the European public assessment report (EPAR) for Filgrastim Hexal. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Filgrastim Hexal.
The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim Hexal on 06 February 2009. 
Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Filgrastim Hexal na snazi u Europskoj uniji od 6. veljače 2009.
Filgrastim Hexal is a ‘biosimilar' medicine. 
Filgrastim Hexal je „biosličan” lijek.
The active substance in Filgrastim Hexal, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF). 
Djelatna tvar u lijeku Filgrastim Hexal, filgrastim, vrlo je sličan ljudskom proteinu naziva čimbenik poticanja rasta granulocitnih kolonija (G-CSF).
What measures are being taken to ensure the safe and effective use of Filgrastim Hexal? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Filgrastim Hexal?
• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing); 
• za smanjenje trajanja neutropenije (niske razine neutrofila, vrste bijelih krvih zrnaca) i incidencije febrilne neutropenije (neutropenije praćene vrućicom) u bolesnika liječenih kemoterapijom (liječenje raka), koja je citotoksična (ubija stanice);
This means that Filgrastim Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine'). 
Drugim riječima, Filgrastim Hexal je sličan biološkom lijeku (poznatom kao „referentni lijek“) koji je već odobren u Europskoj uniji (EU) i sadrži istu djelatnu tvar.
Filgrastim Hexal and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies. 
Lijekovi Filgrastim Hexal i Neupogen rezultirali su otprilike sličnim povećanjem broja neutrofila u krvi dobrovoljaca tijekom tih ispitivanja.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Filgrastim Hexal, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Filgrastim Hexal uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
A risk management plan has been developed to ensure that Filgrastim Hexal is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Filgrastim Hexal.
The Committee recommended that Filgrastim Hexal be given marketing authorisation. 
Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Filgrastim Hexal u promet.
This was considered sufficient to demonstrate that the benefits of Filgrastim Hexal are comparable to those of the reference medicine. 
To se smatralo dostatnim dokazom da su koristi lijeka Filgrastim Hexal usporedive s koristima referentnog lijeka.
The CHMP decided that, in accordance with EU requirements, Filgrastim Hexal has been shown to have a comparable quality, safety and efficacy profile to Neupogen. 
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je kako je u skladu sa zahtjevima EU-a za bioslične lijekove dokazano da lijek Filgrastim Hexal posjeduje usporedivu razinu kvalitete, sigurnosti i djelotvornosti kao i Neupogen.
Filgrastim Hexal is given by injection under the skin or infusion into a vein. 
Filgrastim Hexal se primjenjuje potkožnom injekcijom ili infuzijom u venu.
• to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia; 
• za smanjenje trajanja neutropenije u bolesnika koje se liječi uništavanjem stanica koštane srži nakon čega slijedi transplantacija koštane srži (primjerice u pojedinih bolesnika s leukemijom), ako su pod povećanim rizikom od dugotrajne teške neutropenije;
Filgrastim Hexal was studied to show that it is comparable to the reference medicine, Neupogen. 
Filgrastim Hexal se ispitivao radi dokazivanja njegove usporedivosti s referentnim lijekom, lijekom Neupogen.
For more information, see the package leaflet. 
Za više informacija pročitajte uputu o lijeku.