natgillin/translations-raw huggingface dataset:
The presence of the disease in the herd should be established before metaphylactic treatment. 
Pred metafilaktično uporabo je potrebno dokazati prisotnost bolezni v čredi.
Antibiotic treatment of benign foot rot is not considered appropriate. 
Antibiotično zdravljenje benigne oblike nalezljive šepavosti ovac ni primerno.
The maximum concentration (Cmax) in plasma was approximately 0.6 µg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). 
Najvišji koncentracija (Cmax) v plazmi je okoli 0,6 μg/ml, dosežena pa je približno 30 minut po vnosu (Tmax).
Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of approximately 91 hours in plasma. 
Koncentracijskemu vrhu je sledilo počasno pojemanje sistemskih učinkov z navideznim polovičnim časom izločitve (T½) okoli 91 ur v plazmi.
Tulathromycin also possesses in vitro activity against Moraxella bovis, the bacterial pathogen most commonly associated with infectious bovine keratoconjunctivitis (IBK). 
Tulatromicin izkazuje tudi in vitro aktivnost proti Moraxella bovis patogeni bakteriji, ki je najpogostejša povzročiteljica infekcioznega govejega keratokonjuktivitisa.
It differs from many other macrolides in that it has a long duration of action that is, in part, due to its three amine groups; therefore it has been given the chemical subclass designation of triamilide. 
Za razliko od drugih makrolidov ima tulatromicin podaljšano delovanje, ki je posledica treh amino skupin; ravno zaradi njih uvrščamo tulatromicin v kemično podskupino triamilidov.
The maximum concentration (Cmax) in plasma was approximately 0.5 µg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). 
Najvišja koncentracija (Cmax) v plazmi je okoli 0,5 μg/ml, dosežena pa je približno 30 minut po vnosu (Tmax).
Name and address of the manufacturers responsible for batch release 
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije
In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination. 
Pri prašičih je za farmakokinetični profil tulatromicina, vnešenega z enkratnim intramuskularnim vbrizgom v dozi 2,5 mg/ml, prav tako značilna hitra in obsežna absorpcija, ki ji sledi hitra razporeditev in počasno izločanje.
In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous dose of 2.5 mg/kg bodyweight, was characterised by rapid and extensive absorption followed by high distribution and slow elimination. 
Pri govedu je za farmakokinetični profil tulatromicina, vnešenega z enkratnim podkožnim vbrizgavanjem v dozi 2,5 mg/ml, značilna hitra in obsežna absorpcija, ki ji sledi hitra razporeditev in počasno izločanje.
Bovine 300 µg/kg 200 µg/kg 
Govedo 300 µg/kg
Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of 90 hours in plasma. 
Koncentracijskemu vrhu je sledilo počasno pojemanje sistemskih učinkov z navideznim polovičnim časom izločitve (T½) okoli 90 ur v plazmi.
Vial sizes: 20 ml, 50 ml, 100 ml, 250 ml and 500 ml. 
Velikost vial: 20 ml, 50 ml, 100 ml 250 ml in 500 ml.
The bioavailability of tulathromycin after intramuscular administration in sheep was 100%. 
Biorazpoložljivost tulatromicina po intramuskularnem vnosu pri ovcah je 100%.
Cattle: SC. Pigs and sheep: IM. 
Prašiči in ovce: i.m.
Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment. 
Za zdravljenje nalezljive šepavosti ovac je potrebno upoštevati vsa merila dobrega upravljanja s čredo, kot naprimer zagotavljanje suhega okolja.
Draxxin 25 mg/ml: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 
Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIJA
Draxxin 100 mg/ml: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANCE 
FAREVA AMBOISE Zone Industrielle, 29 route des Industries
For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site. 
Za goveda s telesno maso nad 300 kg, je potrebno odmerek razdeliti tako, da na eno mesto injiciranja ne vbrizgamo več kot 7,5 ml zdravila.
Pigs (meat and offal): 13 days. 
Prašiči (meso in organi): 13 dni.
Cattle: For subcutaneous use. 
NAČIN IN POT(I) UPORABE Govedo: za subkutano uporabo.
The bioavailability of tulathromycin after subcutaneous administration in cattle was approximately 90%. 
Biorazpoložljivost tulatromicina po podkožnem vnosu pri govedu je približno 90%.
In sheep, transient signs of discomfort (head shaking, rubbing injection site, backing away) are very common after intramuscular injection. 
Pri ovcah so prehodni znaki neugodja (stresanje glave, drgnjenje mesta injiciranja, umikanje) so zelo pogosti po intramuskularnem injiciranju.
Sheep (meat and offal): 16 days. 
Ovce (meso in organi): 16 dni.
4500 µg/kg 3000 µg/kg 
4500 μg/kg 3000 μg/kg
SPECIAL WARNING(S), IF NECESSARY 
POSEBNO(A) OPOZORIL(O)A
INDICATIONS Cattle 
INDIKACIJA(E) Govedo
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (20 ml / 50 ml / 100 ml / 250 ml) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (20 ml / 50 ml / 100 ml / 250 ml)
The bioavailability of tulathromycin after intramuscular administration in pigs was approximately 88%. 
Biološka uporabnost tulatromicina po podkožnem vnosu pri prašičih je približno 88%.
Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition. 
Ne uporabite pri brejih živalih, katerih mleko je namenjeno prehrani ljudi, v obdobju 2 mesecev pred pričakovanim porodom.
In sheep transient signs of discomfort (head shaking, rubbing injection site, backing away) are very common after intramuscular injection. 
Prehodni znaki neugodja (stresanje glave, drgnjenje mesta injiciranja, umikanje) so zelo pogosti po intramuskularnem injiciranju.
In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. 
Pri mladih prašičih s telesno maso okoli 10 kg, ki so prejeli trikraten oziroma petkraten terapevtski odmerek, so bili opaženi prehodni znaki, vezani predvsem na moteč občutek na mestu vbrizgavanja, glasno oglašanje in nemir.
Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are present for approximately 30 days after injection. 
Patomorfološke reakcije na mestu injiciranja (vključno z reverzibilnimi spremembami kongestije, edem, fibroza in krvavitve) so prisotne približno 30 dni po injiciranju.
Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are very common for approximately 30 days after injection in cattle and pigs. 
Patomorfološke reakcije na mestu injiciranja (vključno z reverzibilnimi spremembami kongestije, edemom, fibrozo in krvavitvami) so zelo pogoste, še približno 30 dni po injiciranju pri govedu in prašičih.
Do not use simultaneously with other macrolides or lincosamides (see section 4.8). 
Ne uporabite zdravila skupaj z drugimi makrolidnimi antibiotiki ali linkozamidi (glej poglavje 4.8) 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Jih ni.
Increased minimum inhibitory concentration (MIC) values have been found in some isolates of Histophilus somni and Actinobacillus pleuropneumoniae. 
Pri nekaterih izolatih Histophilus somni in Actinobacyllus pleuropneumoniae so bile ugotovljene povišane vrednosti minimalne inhibitorne koncentracije (MIC).
Do not use simultaneously with other macrolides or lincosamides. 
Ne uporabite zdravila skupaj z drugimi makrolidnimi antibiotiki ali linkozamidi.
Mild myocardial degeneration has been observed in cattle receiving 5 to 6 times the recommended dose. 
Pri govedu, ki je dobilo 5-6 kratni odmerek, je bila opažena rahla degeneracija miokarda.
In vitro activity against Dichelobacter nodosus (vir), the bacterial pathogen most commonly associated with infectious pododermatitis (foot rot) in sheep has been demonstrated. 
Dokazano je bilo In vitro delovanje proti bakteriji Dichelobacter nodosus (vir), pathogenu, ki je najpogosteje povezan z nalezljivo šepavostjo ovac.
Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma. 
V homogenizatu pljučnega tkiva je bil zaznan tulatromicin v bistveno višji koncentraciji kot v plazmi, kar očitno kaže na njegovo obilno kopičenje v nevtrofilcih in alveolarnih makrofagih.
Cattle (meat and offal): 22 days. 
Govedo (meso in organi): 22 dni.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Tulatromicin draži očesno sluznico.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (50 ml / 100 ml / 250 ml) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (50 ml / 100 ml / 250 ml)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (500 ml) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (500 ml)
Meat and offal: 13 days. 
Meso in organi:13 dni.
Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis and Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively. 
Tulatromicin izkazuje in vitro aktivnost proti Mannheimia haemolytica, Pasteurella multocida, Histophilus somni in Mycoplasma bovis ter proti Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis in Bordetella bronchiseptica to je proti patogenim bakterijam, ki so najpogostejši povzročitelji obolenj dihal pri govedu in prašičih.
Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. 
Zdravljenje in metafilaksa dihalnih obolenj goveda (BRD), povzročenih z Mannheimia haemolytica, Pasteurella multocida, Histophilus somni in Mycoplasma bovis občutljivih na tulatromicin.
For treatment of pigs over 40 kg bodyweight, divide the dose so that no more than 4 ml are injected at one site. 
Pri zdravljenju prašičev, ki so težji od 40 kg, je potrebno odmerek razdeliti tako, da na eno mesto injiciranja ne vbrizgamo več kot 4 ml zdravila.
For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site. 
Pri zdravljenju prašičev, ki so težji od 80 kg, je potrebno odmerek razdeliti tako, da na eno mesto injiciranja ne vbrizgamo več kot 2 ml zdravila.
Porcine 800 µg/kg 300 µg/kg 
800 µg/kg 300 μg/kg
Do not use in lactating animals producing milk for human consumption. 
Ne uporabite zdravila pri živalih, namenjenih za proizvodnjo mleka za prehrano ljudi.
Lameness was also observed when the hind leg was used as the injection site. 
V primeru vbrizgavanja v zadnjo nogo so bili opaženi tudi znaki ohromelosti.
EXP Shelf life after first opening the container: 28 days. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP. Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
Draxxin 100 mg/ml solution for injection for cattle tulathromycin 
Draxxin 100 mg/ml raztopina za injiciranje za govedo tulatromicin
Liver Kidney 
Jetra Ledvice
Draxxin 25 mg/ml solution for injection for pigs tulathromycin 
Draxxin 25 mg/ml raztopina za injiciranje za prašiče tulatromicin
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial (500 ml) 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNIH OVOJNINAH Viala (500 ml)
Draxxin 25 mg/ml solution for injection for pigs 
Draxxin 25 mg/ml raztopina za injiciranje za prašiče
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial (100 ml / 250 ml) 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNIH OVOJNINAH Viala (100 ml / 250 ml)
EXP Once broached use by 
EXP Načeto zdravilo uporabite do…
In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. 
Pri govedu so bili pri vbrizgavanju trikratne, petkratne in desetkratne priporočene doze opaženi prehodni znaki, vezani predvsem na moteč občutek na mestu vbrizgavanja.
Marker residue Animal species 
Marker ostanek
Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep Tulathromycin 
Draxxin 100 mg/ml raztopina za injiciranje za goveda, prašiče in ovce tulatromicin
PACKAGE LEAFLET: Draxxin 25 mg/ml solution for injection for pigs 
NAVODILO ZA UPORABO Draxxin 25 mg/ml raztopina za injiciranje za prašiče
Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. 
Zdravljenje in metafilaksa dihalnih obolenj prašičev (SRD), povzročenih z Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae,Haemophilus parasuis in
Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep 
Draxxin 100 mg/ml raztopina za injiciranje za govedo, prašiče in ovce
Not for use in animals from which milk is produced for human consumption. 
Ni za uporabo pri živalih v laktaciji, katerih mleko je namejeno za prehrano ljudi.
PACKAGE LEAFLET: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep 
NAVODILO ZA UPORABO Draxxin 100 mg/ml raztopina za injiciranje za govedo, prašiče in ovce
A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight) in the neck. 
Enkratna intramuskularna injekcija tulatromicina v odmerku 2,5 mg/kg telesne mase (kar ustreza 1 ml na 40 kg telesne mase) v področje vratu.
A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight). 
Enkratno podkožno dajanje tulatromicina v odmerku 2,5 mg/kg telesne mase (kar ustreza 1 ml na 40
The volume of distribution at steady-state (VSS) determined after intravenous administration was 11 l/kg. 
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenoznem vnosu je 11 L/kg.
The volume of distribution at steady-state (Vss) determined after intravenous administration was 11 l/kg. 
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenoznem vnosu je 11 l/kg.
In lambs (approx. 6 weeks old), at dosages of three or five times the recommended dose, transient signs attributed to injection site discomfort were observed, and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, bleating. 
Pri jagnjetih (približno 6 tednov starih), ki so prejeli trikraten oziroma petkraten priporočeni odmerek,so bili opaženi prehodni znaki, vezani predvsem na moteč občutek na mestu injiciranja,
Following intravenous dosing the volume of distribution at steady-state (Vss) was 31.7 l/kg. 
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenoznem vnosu je 31.7 L/kg.
Ovine, caprine 
Govedo: s.c.
The volume of distribution at steady-state (VSS) determined after intravenous administration was 13.2 l/kg. 
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenoznem vnosu je 13,2 L/kg.
The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 L/kg. 
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenoznem vnosu je 13,2 l/kg.
A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/10 kg bodyweight) in the neck. 
Enkratno intramuskularno dajanje tulatromicina v odmerku 2,5 mg/kg telesne mase (kar ustreza 1 ml na 10 kg telesne mase) na področje vratu.
Withdrawal period: Meat and offal: 22 days. 
Meso in organi: Govedo: 22 dni.
Kidney 
Ledvice
Strength Pharmaceutical Form 
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
(Invented) name Strength Pharmaceutical Form 
Zaščiteno ime Jakost Farmacevtska oblika Pot uporabe
Talk to your doctor or pharmacist before taking this medicine if you have any of the following conditions. 
Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom ali farmacevtom, če imate katero od naslednjih stanj.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC. 
Pristojni organi države članice lahko v sodelovanju z referenčno državo članico posodobijo informacije o zdravilu, kot je primerno, v skladu s postopki, opisanimi v poglavju 4 naslova III Direktive 2001/83/ES.
The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below. 
Obstoječe informacije o zdravilu je treba posodobiti (vstavitev, zamenjava ali izbris besedila, kot je ustrezno) tako, da bodo odražale spodaj navedeno dogovorjeno besedilo.
4.3 Contraindications [The following contraindication should be included] 
4.3 Kontraindikacije [Vključiti je treba naslednjo kontraindikacijo]
These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure. 
Te spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
What you need to know before you are given <invented name> Do not use <invented name and strength(s)>: 
Kaj morate vedeti, preden boste prejeli zdravilo <izmišljeno ime> Ne uporabljajte zdravila <izmišljeno ime in jakost(i)>:
[A warning should be included as follows. 
[Vključiti je treba naslednje opozorilo.
4.4 Special warnings and precautions for use [The following warning should be included] Immune System Effects 
4.4 Posebna opozorila in previdnostni ukrepi [Vključiti je treba naslednje opozorilo] Učinki na imunski sistem
Administration of <invented name and strength(s)> should be stopped, and the patient's condition should be treated accordingly. 
Dajanje zdravila <izmišljeno ime in jakost(i)> je treba prekiniti in bolnikovo stanje ustrezno zdraviti.
If you are allergic or suspected to be allergic to cow's milk. 
Če ste alergični ali obstaja sum, da ste alergični na kravje mleko.
[A warning should be included as follows] 
[Vključiti je treba naslednje opozorilo]
In case of combined package leaflet with strength(s) not included in Annex I, the strength(s) of products in Annex I should be specified in the subheading above] 
V primeru kombiniranega navodila za uporabo zdravila z jakostjo (jakostmi), ki ni(so) vključena (vključene) v Prilogo I, je treba jakost(i) zdravil iz Priloge I navesti v zgornjem podnaslovu.]
Cow's milk allergy [The following clarification in brackets should be included in case of combined SmPC with strength(s) not included in Annex I] (the following paragraphs only apply to <invented name and strength(s)>) 
Alergija na kravje mleko [naslednje pojasnilo v oklepaju je treba vključiti v primeru kombiniranega povzetka glavnih značilnosti zdravila z jakostjo (jakostmi), ki ni(so) vključena (vključene) v Prilogo I] (naslednji odstavki se nanašajo samo na zdravilo <izmišljeno ime in jakost(i)>)
OTHER [A warning should be included as follows] Do not use in cow's milk allergy patients. 
DRUGI PODATKI [Vključiti je treba naslednje opozorilo] Ne uporabljajte pri bolnikih z alergijo na kravje mleko.
<Invented name and strength(s)> contains lactose <monohydrate> produced from bovine origin as an excipient and may therefore contain trace amounts of cow's milk proteins (the allergens of cow's milk). 
Zdravilo <izmišljeno ime in jakost(i)> kot pomožno snov vsebuje laktozo <monohidrat> govejega izvora, zato lahko vsebuje sledove beljakovin kravjega mleka (alergene kravjega mleka).
OTHER SPECIAL WARNING(S), IF NECESSARY [A warning should be included as follows] Do not use in cow's milk allergy patients. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA [Vključiti je treba naslednje opozorilo] Ne uporabljajte pri bolnikih z alergijo na kravje mleko.
Serious allergic reactions have occurred in patients allergic to cow's milk. 
Pri bolnikih, alergičnih na kravje mleko, so se pojavile resne alergijske reakcije.
Patients with known or suspected allergy to cow's milk must not be administered <invented name and strength(s)> (see section 4.3). 
Bolniki z znano alergijo na kravje mleko ali sumom nanjo ne smejo prejemati zdravila <izmišljeno ime in jakost(i)> (glejte poglavje 4.3).
<Invented name and strength(s)> is contraindicated in patients with a known or suspected allergy to cow's milk (see section 4.4). 
Zdravilo <izmišljeno ime in jakost(i)> je kontraindicirano pri bolnikih z znano alergijo na kravje mleko ali sumom nanjo (glejte poglavje 4.4).
<invented name and strength(s)> contains cow's milk proteins If you are allergic or suspected to be allergic to cow's milk, you must not be given this medicine as it may contain trace amounts of cow's milk proteins. 
Če ste alergični ali obstaja sum, da ste alergični na kravje mleko, tega zdravila ne smete prejeti, saj lahko vsebuje sledove beljakovin kravjega mleka.
Serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients allergic to cow's milk proteins who were treated for acute allergic conditions. 
Pri bolnikih, alergičnih na beljakovine kravjega mleka, ki so se zdravili zaradi akutnih alergijskih stanj, so poročali o resnih alergijskih reakcijah, vključno z bronhospazmom in anafilakso.
Allergic reactions to cow's milk proteins should be considered in patients receiving <invented name and strength(s)> for the treatment of acute allergic conditions in whom symptoms worsen or who are presenting new allergic symptoms (see section 4.3). 
Pri bolnikih, ki prejemajo zdravilo <izmišljeno ime in jakost(i)> za zdravljenje akutnih alergijskih stanj, pri katerih se simptomi poslabšajo ali se pojavijo novi alergijski simptomi, je treba upoštevati možnost alergijskih reakcij na beljakovine kravjega mleka (glejte poglavje 4.3).
MA (EU) number 
Štvilka (EU) dovoljenja za promet
Immediate Packaging Pack size 
100 mg filmska obložena tableta
Severe neutropenia lasted on average for 1.4 days. 
Huda nevtropenija je v povprečju trajala 1,4 dni.
The main measure of effectiveness was the duration of severe neutropenia. 
Glavno merilo učinkovitosti je bilo trajanje hude nevtropenije.
This is comparable with 1.6 days and 1.8 days reported in other studies found in the literature using filgrastim. 
To je primerljivo z 1,6 dni in 1,8 dni, o katerih so poročali v drugih študijah v literaturi, v katerih so uporabljali filgrastim.
The European Commission granted a marketing authorisation valid throughout the European Union for Accofil on 18 September 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Accofil, veljavno po vsej Evropski uniji, izdala 18. septembra 2014.
What measures are being taken to ensure the safe and effective use of Accofil? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Accofil?
The full EPAR and risk management plan summary for Accofil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Accofil sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.