natgillin/translations-raw huggingface dataset:
It is used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults who are totally blind. 
Koristi se za liječenje poremećaja cirkadijanog ritma budnosti i spavanja koji ne traje 24 sata, kod odraslih osoba koje su potpuno slijepe.
Contains lactose and Orange Yellow S (E110). 
Sadrži laktozu i boju Orange Yellow S (E110).
Aspartate aminotransferase increased, gamma-glutamyl transferase increased 
Povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti gamaglutamiltransferaze
HETLIOZ 20 mg hard capsules tasimelteon 
HETLIOZ 20 mg tvrde kapsule tazimelteon
- The other ingredients are lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. 
Ostali su sastojci bezvodna laktoza, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni silicijev dioksid i magnezijev stearat.
The most abundant metabolites of tasimelteon have less than onetenth of the binding affinity of the parent molecule for both the MT1 and MT2 receptors. 
Najzastupljeniji metaboliti tazimelteona pokazuju manje od jedne desetine afiniteta vezanja ishodišne molekule i za receptore MT1 i receptore MT2.
- medicines known to reduce the activity of an enzyme called ‘CYP2C19'. 
- lijekove koji smanjuju aktivnost enzima pod nazivom „CYP2C19”.
Potential for other medicinal products to affect tasimelteon CYP1A2 and CYP3A4 are enzymes identified to play a role in the metabolism of tasimelteon, with a minor role for CYP2C9/C19. 
CYP1A2 i CYP3A4 su enzimi za koje je utvrđeno da imaju ulogu u metabolizmu tazimelteona, dok manju ulogu ima CYP2C9/C19.
Patients treated with tasimelteon experienced an overall improvement in clinical global functioning (CGIC = 2.6) as compared to patients treated with placebo who showed no improvement status (CGI-C = 3.4) compared to the severity of Non-24 at baseline (LS mean difference = -0.8; p=0.0093) (Table 4). 
Odgovor u mjerama kliničke procjene općeg funkcioniranja Bolesnicima liječenima tazimelteonom općenito se poboljšala klinička procjena općeg funkcioniranja (rezultat CGI-C = 2,6) u usporedbi s bolesnicima liječenima placebom, u kojih nije bilo vidljivog poboljšanja (rezultat CGI-C = 3,4) u usporedbi s težinom poremećaja cirkadijanog ritma koji ne traje 24 sata na početku ispitivanja (srednja vrijednost razlike dobivena metodom najmanjih kvadrata = -0,8; p = 0,0093) (Tablica 4).
HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults. 
HETLIOZ je indiciran za liječenje poremećaja cirkadijalnog ritma budnosti i spavanja koji ne traje 24 sata, u potpuno slijepih odraslih osoba.
Tasimelteon exhibits a greater affinity for the MT2 as compared to the MT1 receptor. 
Tazimelteon pokazuje veći afinitet za receptore MT2 u odnosu na receptore MT1.
HETLIOZ contains lactose 
HETLIOZ sadrži laktozu
HETLIOZ 20 mg hard capsules 
HETLIOZ 20 mg tvrde kapsule
- medicines called “beta blockers” used to treat high blood pressure and other heart problems. 
Primjer je omeprazol koji se upotrebljava za liječenje žgaravice i gastroezofagealne refluksne bolesti (GERB). - lijekove koji se nazivaju „beta blokatori”, a koriste se za liječenje visokog krvnog tlaka i ostalih srčanih problema.
Clinical response in sleep-wake amount and timing measures SET and RESET evaluated the duration and timing of nighttime sleep and daytime naps via patient-recorded diaries. 
Ispitivanjima SET i RESET ocijenjeno je trajanje i vrijeme nastupa noćnog sna i dnevnih drijemanja putem dnevnika koje su vodili bolesnici.
Tasimelteon functions as a DMRA at the MT1 and MT2 receptors. 
Tazimelteon djeluje kao DMRA na receptorima MT1 i MT2.
No dose adjustment is necessary for patients with renal impairment. 
Nije potrebna prilagodba doze za bolesnike s oštećenjem funkcije bubrega.
HETLIOZ contains lactose. 
HETLIOZ sadrži laktozu.
HETLIOZ contains Orange Yellow S (E110) which may cause allergic reactions. 
Yellow S (E110) koja može izazvati alergijske reakcije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 30-COUNT BOTTLE 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BOCU KOJA SADRŽI 30 TABLETA
Dyspepsia, nausea, dry mouth 
Dispepsija, mučnina,
Uncommon: may affect up to 1 in 100 people - abnormal or change in taste - blood tests which show changes in the way the liver is working (aspartate aminotransferase and gamma-glutamyl transferase) - increase in daytime urination - nightmares - ringing in the ears - feeling foggy in the head 
- neobičan okus ili promjena okusa - krvne pretrage koje pokazuju promjene u načinu rada jetre (aspartat aminotransferaza i gama glutamiltransferaza)
Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2). 
Ne preporuča se prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2.).
- medicines known to reduce the activity of an enzyme called ‘CYP3A4'. 
- lijekove koji smanjuju aktivnost enzima pod nazivom „CYP3A4”.
The pharmacokinetic profile of a 20 mg dose of tasimelteon was compared among 8 subjects with mild hepatic impairment (Child-Pugh Score ≥5 and ≤6 points), 8 subjects with moderate hepatic impairment 
Farmakokinetički profil doze tazimelteona od 20 mg tazimeluspoređen je među 8 ispitanika s blagim oštećenjem funkcije jetre (Child-Pugh rezultat ≥ 5 i ≤ 6 bodova), 8 ispitanika s umjerenim oštećenjem funkcije jetre (Child-Pugh rezultat ≥ 7 i ≤ 9 bodova) te 13 zdravih odgovarajućih kontrola.
Caution should be used when administering tasimelteon in combination with fluvoxamine or other strong CYP1A2 inhibitors such as ciprofloxacin and enoxacin because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions: the AUC0-inf and Cmax of tasimelteon increased by 7-fold and 2-fold, respectively, when co-administered with fluvoxamine 50 mg (after 6 days of fluvoxamine 50 mg per day). 
inhibitorima kao što su ciprofloksacin i enoksacin zbog mogućeg velikog povećanja izloženosti tazimelteonu i većeg rizika od nuspojava: AUC0-inf povećao se 7 puta, a Cmax tazimelteona 2 puta kada su primijenjeni istodobno s fluvoksaminom od 50 mg (nakon 6 dana uzimanja fluvoksamina od 50 mg dnevno).
It may harm them, even if their signs of illness are the same as yours. 
Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki vašima.
HETLIOZ hard capsules are opaque dark blue printed with “VANDA 20 mg” in white. 
HETLIOZ tvrde kapsule neprozirne su i tamnoplave boje označene bijelom tintom oznakom „VANDA 20 mg”.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR 30-COUNT BOTTLE 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA ZA BOCU KOJA SADRŽI 30 TABLETA
Date of first authorisation: 3 July 2015 
Datum prvog odobrenja:
Package leaflet: Information for the patient HETLIOZ 20 mg hard capsules 
Uputa o lijeku: Informacija za bolesnika HETLIOZ 20 mg tvrde kapsule tazimelteon
Clinical Response in Non-24-Hour Sleep-Wake Disorder The effectiveness of tasimelteon in the treatment of clinical symptoms, including the circadian sleep-wake cycle and clinical global functioning in patients with Non-24 was established in SET and RESET (Table 3). 
Učinkovitost tazimelteona u liječenju kliničkih simptoma, uključujući cirkadijani ciklus budnosti i spavanja i kliničku procjenu općeg funkcioniranja u bolesnika s poremećajem cirkadijalnog ritma koji ne traje 24 sata, utvrđena je ispitivanjima SET i RESET (Tablica 3).
SET Study Clinical response (Entrainment + N24CRS 
Klinički odgovor (usklađivanje + N24CRS N24CRS ≥ 3(2)
How to take HETLIOZ 
Kako uzimati HETLIOZ
The effectiveness of tasimelteon in the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) was established in two randomised, double-masked, placebo-controlled, multicentre, parallel-group studies (SET and RESET) in totally blind patients with Non-24. 
Klinička djelotvornost i sigurnost Učinkovitost tazimelteona u liječenju poremećaja cirkadijanog ritma budnosti i spavanja koji ne traje 24 sata utvrđena je u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja s usporednim skupinama (SET i RESET) na potpuno slijepim bolesnicima s poremećajem cirkadijalnog ritma koji ne traje
Hard capsule shell Gelatin 
Ovojnica tvrde kapsule Želatina
> 45 min improvement in both nighttime and daytime sleep (%)(5) 
> 45-minutno poboljšanje u noćnom i dnevnom snu (%)(5) Vrijeme nastupa sna (u minutama)(1),(3) Ispitivanje RESET
Caution should be used when administering HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors, particularly those which also inhibit other enzymes involved in the clearance of HETLIOZ because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions (see section 4.5). 
CYP1A2 inhibitorima, naročito onima koji inhibiraju i druge enzime uključene u klirensu lijeka HETLIOZ zbog mogućeg velikog povećanja izloženosti tazimelteonu i većeg rizika od nuspojava (vidjeti dio 4.5.).
Hard capsule core Lactose anhydrous Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium sterate 
Umrežena karmelozanatrij Silicijev dioksid, koloidni bezvodni Magnezijev stearat
Common: may affect up to 1 in 10 people - change in sleeping pattern - difficulty in sleeping - dizziness - dry mouth - tiredness - indigestion - feeling sick in the stomach - blood tests which show changes in the way the liver is working (alanine aminotransferase) - unusual dreams - sleepiness 
- mučnina u želucu - krvne pretrage koje pokazuju promjene u načinu rada jetre (alanin aminotransferaza) - neobični snovi
The apparent oral volume of distribution at steady state of tasimelteon in young healthy subjects is approximately 59 - 126 L. At therapeutic concentrations, tasimelteon is about 88.6 - 90.1% bound to proteins. 
Pri terapijskim koncentracijama, tazimelteon se veže za bjelančevine otprilike 88,6 - 90,1 %.
RESET Study 
Ispitivanje SET
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Prilogu V.
Tasimelteon has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing HETLIOZ to patients with severe hepatic impairment. 
Tazimelteon nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C); stoga je pri propisivanju lijeka
Pollakiuria 
Propilenglikol
There was no increase in tumours at the lowest dose tested in rats, which is approximately 10 times the recommended human doseon a mg/m2 basis. 
koje su otprilike 10 puta više od preporučene doze za ljude na bazi mg/m2.
This is deemed even more important for strong CYP1A2 inhibitors also inhibiting other enzymes involved in the clearance of HETLIOZ (e.g. fluvoxamine and ciprofloxacin). 
Smatra se da je to još važnije za jake CYP1A2 inhibitore koji inhibiraju i druge enzime uključene u klirensu lijeka
How HETLIOZ works 
Kako djeluje HETLIOZ
How to store HETLIOZ 
Kako čuvati HETLIOZ
Effects of Tasimelteon 20 mg Treatment on Clinical Response in Non-24 Tasimelteon 20 mg Placebo 
Tablica 3: Učinak liječenja tazimelteonom u dozi od 20 mg na klinički odgovor bolesnika s poremećajem cirkadijanog ritma koji ne traje 24 sata
Taking HETLIOZ 
Uzimanje lijeka HETLIOZ
This includes: - medicines known to reduce the activity of an enzyme called ‘CYP1A2'. 
- lijekove koji smanjuju aktivnost enzima pod nazivom „CYP1A2”.
HETLIOZ contains the active substance tasimelteon. 
HETLIOZ sadrži djelatnu tvar tazimelteon.
Clinical Global Functioning in Non-24 Patients Tasimelteon 20 mg 
Tablica 4: Klinička procjena općeg funkcioniranja bolesnika s poremećajem cirkadijalnog ritma koji ne traje 24 sata Tazimelteon 20 mg
Orange Yellow S (E110) 
Boja Orange Yellow S (E110) Bijela tinta za označavanje
CGI-C (LS mean) 
CGI-C (srednja vrijednost dobivena metodom najmanjih kvadrata)
Entrainment in Non-24-Hour Sleep-Wake Disorder 
Usklađivanje u bolesnika s poremećajem cirkadijalnog ritma budnosti i spavanja koji ne traje 24 sata
You can help by reporting any side effects you may get. 
Prijavom svih sumnji na nuspojavu i sami možete pomoći.
Nighttime sleep on 25% most symptomatic nights >45 minutes increase in average nighttime sleep duration 
Noćni san u 25 % najsimptomatskijih noći
Sensitive to light. 
Osjetljivo na svjetlost.
Do not exceed the stated dose. 
Ne prekoračite naznačenu dozu.
The intervals between the two administrations should not be less than 3 days or more than 17 days. 
Razmak između dvije primjene ne bi smio biti manji od 3 dana ili veći od 17 dana.
In rare cases, the animal may collapse. 
U rijetkim slučajevima, životinja može kolabirati.
There is no known antidote. 
Ne postoji poznati protuotrov.
The product may be stored at 25 °C for 24 hours maximum. 
Proizvod se može čuvati na 25 °C kroz najviše 24 sata.
The syringes are packed into cardboard boxes as follows; 
Štrcaljke su pakirane u kartonske kutije kako slijedi;
Arginine. 
Arginin.
ATCvet code: QL03AA90 
ATCvet kod: QL03AA90
Bovine No MRL required 
Goveda MRL se ne zahtijeva
These clinical signs typically appear between 30 minutes and 2 hours after the first dose and resolve within 2 hours. 
Ovi se klinički znakovi tipično javljaju između 30 minuta i 2 sata nakon prve doze i nestanu unutar 2 sata.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. 
Pitajte vašeg veterinara ili farmaceuta kako odlagati proizvode koji vam više nisu potrebni.
Store in original packaging. 
Čuvati u originalnom pakovanju.
Shelf -life after first opening the immediate packaging: use immediately. 
Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: upotrijebiti odmah.
The product increases the number of circulating neutrophils. 
Proizvod povećava broj neutrofila u cirkulaciji.
Only clear solutions without particles should be used. 
Treba primjenjiti samo bistre otopine bez čestica.
Biological/ Immunomodulat or 
Biološki/Imuno modulator
Available in boxes of 10, 50 or 100 syringes. 
Dostupan u kutijama od 10, 50 ili 100 štrcaljki.
Clinical mastitis is investigated as a change in the appearance of the milk or of the quarter or of both milk and quarter. 
Klinički mastitis ispitan je kao promjena izgleda mlijeka ili četvrti ili oboje (mlijeka i četvrti).
Water for injections. 
Voda za injekcije.
During this EU study, 312 cows were treated with Imrestor for every 10 cases of clinical mastitis that were prevented during the periparturient period. 
Tijekom ovog ispitivanja u EU, 312 krava je tretirano Imrestorom na svakih 10 slučajeva kliničkog mastitisa koji su bili spriječeni tijekom peripartalnog razdoblja.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/12/2015 
Datum prvog odobrenja: 09/12/2015
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.7 ml pre-filled syringe contains: 
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka 2,7 ml napunjena štrcaljka sadrži:
Do not mix with any other veterinary medicinal products. 
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.
Symptomatic treatment may be required. 
Katkada je možda potrebno simptomatsko liječenje.
Colony stimulating factors regulate the production and functional activities of immune cells. 
Faktori stimulacije kolonija reguliraju proizvodnju i funkcionalne aktivnosti imunosnih stanica.
Milk: zero days. 
Mlijeko: nula dana.
MARKETING AUTHORISATION NUMBER(S) EU/2/15/193/001-003 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/15/193/001-003
The efficacy was tested together with normal management practice. 
Djelotvornost je ispitana zajedno s korištenjem uobičajenog programa upravljanja.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Detaljnije informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove (http://www.ema.europa.eu/).
Concurrent use of such products should be avoided. 
Treba izbjegavati istodobnu primjenu takvih proizvoda.
A single syringe delivers a dose of 20-40 µg/kg pegbovigrastim for most cows depending on bodyweight: e.g. a dose of 21 µg/kg bodyweight for a 700 kg cow or 33 µg/kg bodyweight for a 450 kg heifer. 
Jedna štrcaljka sadrži dozu od 20 - 40 µg/kg pegbovigrastima koja je dovoljna za većinu krava ovisno o njihovoj tjelesnoj težini: npr. doza od 21 µg/kg tjelesne težine je za kravu od 700 kg ili 33 µg/kg tjelesne težine je za junicu od 450 kg.
The treatment regimen consists of two syringes. 
Program primjene sastoji se od dvije štrcaljke.
The active substance in Imrestor 15 mg solution for injection for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: 
Djelatna tvar u lijeku Imrestor 15 mg otopina za injekcije za goveda je dozvoljena tvar kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
Personal protective equipment consisting of gloves should be worn when handling broken or damaged syringes. 
Pribor za osobnu zaštitu koji se sastoji od rukavica treba koristiti pri rukovanju slomljenim ili oštećenim štrcaljkama.
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 product. 
Pomoćne tvari navedene u dijelu 6.1 SPC-a su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nijenužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and on the pre-filled syringe. 
Ne koristite ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i na napunjenoj štrcaljki.
If you notice any serious effects or other effects not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 
Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP, molimo obavijestite svog veterinara.
Medicines should not be disposed of via wastewater or household waste. 
Proizvod se ne smije odlagati u otvorene vode ili kućni otpad.
Citric acid monohydrate. 
Citratna kiselina hidrat.
As an aid in a herd management programme, to reduce the risk of clinical mastitis in periparturient dairy cows and heifers during the 30 days following calving. 
Koristi se kao pomoć u programu upravljanja stadom čiji je cilj smanjenje rizika pojave kliničkog mastitisa u peripartalnom razdoblju mliječnih krava i junica tijekom 30 dana nakon teljenja.
Subcutaneous administration of the product may induce transient local swelling at the injection site as well as inflammatory reactions which resolve within 14 days post treatment. 
Potkožna primjena proizvoda može izazvati prolazno lokalno oticanje na mjestu primjene injekcije kao i upalne reakcije koje nestaju unutar 14 dana nakon liječenja.
Pregnancy and lactation: Can be used in pregnancy and lactation 
Graviditet i laktacija: Može se primjeniti tijekom graviditeta i laktacije.
PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow solution 
OBLIK Otopina za injekciju Bistra, bezbojna do blijedo žuta otopina
The solution should be visually inspected prior to use. 
Zato otopinu treba vizualno pregledati prije primjene.
The content of a single pre-filled syringe is to be injected subcutaneously to a dairy cow/heifer 7 days before the anticipated date of calving. 
Sadržaj jedne napunjene štrcaljke treba injicirati potkožno mliječnoj kravi/junici 7 dana prije očekivanog datuma teljenja.
In animals, which have pharmaceutically altered immune function e.g. those which have recently received systemically administered corticosteroids or non-steroidal anti-inflammatory drugs the product may not be effective. 
Kod životinja kojima je farmaceutski izmijenjen imunosni sustav npr. one koje su nedavno primile sustavno primijenjene kortikosteroide ili nesteroidne protuupalne lijekove, proizvod možda neće biti djelotvoran.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports) 
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu/e za vrijeme trajanja jednog tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
In a European field trial, the incidence of clinical mastitis observed in the treated group was 9.1 % (113/1235) and in the control group 12.4 % (152/1230), showing a relative reduction in mastitis incidence of 26.0 % (p=0.0094). 
U europskom terenskom ispitivanju pojava kliničkog mastitisa bila je 9,1 % (113/1235) u tretiranoj skupini, a u kontrolnoj skupini je bila 12,4 % (152/1230), što ukazuje na relativno smanjenje pojave mastitisa od 26 % (p=0,0094).
People with known hypersensitivity to pegbovigrastim should avoid contact with the veterinary medicinal product. 
Osobe preosjetljive na pegbovigrastim trebaju izbjegavati kontakt s ovim veterinarsko-medicinskim proizvodom.
2.7 ml of solution for injection in a pre-filled polypropylene colourless syringe with siliconised chlorobutyl stopper and a stainless steel needle with needle guard. 
2,7 ml otopine za injekciju u napunjenoj polipropilenskoj bezbojnoj štrcaljki sa silikoniziranim klorobutilnim čepom i iglom od nehrđajučeg čelika s poklopcem.
In the case of accidental self-injection, headache and bone and muscle pain may occur. 
U slučaju da se nehotično samoinjicira, mogu se pojaviti glavobolja i bol u kostima i mišićima.
Meat and offal: zero days Milk: zero days 
Meso i jestive iznutrice: nula dana Mlijeko: nula dana
As expected from the mode of action of the active substance, safety data shows that a mild and transient rise in somatic cell counts in individual cows may be seen. 
Kako se može očekivati po načinu djelovanja djelatne tvari, podaci o neškodljivosti pokazuju da se može uočiti blag i prolazan porast broja somatskih stanica kod pojedinačnih krava.
Pharmacotherapeutic group: Colony stimulating factors. 
FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: faktor stimulacije kolonija.
STATEMENT OF ACTIVE SUBSTANCES Each 2.7 ml pre-filled syringe contains 15 mg pegbovigrastim. 
SASTAV DJELATNIH TVARI Svaka 2,7 ml napunjena štrcaljka sadrži 15 mg pegbovigrastima.
Excessive shaking of the syringe may aggregate pegbovigrastim, reducing its biological activity. 
Pretjerana trešnja štrcaljke može uzrokovati skupljanje (agregaciju) pegbovigrastima, smanjujući njegovu biološku aktivnost.
Cattle (dairy cows and heifers). 
Goveda (mliječne krave i junice).
Imrestor 15 mg injection pegbovigrastim 
Imrestor 15 mg injekcija pegbovigrastim
Pegbovigrastim (Pegylated bovine Granulocyte Colony Stimulating Factor [PEG bG-CSF]) 15 mg For the full list of excipients, see section 6.1. 
Pegbovigrastim (pegilirani goveđi faktor stimulacije granulocitnih kolonija [PEG bG-CSF]) 15 mg Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
Only for subcutaneous injection. 
Samo za potkožnu injekciju.