natgillin/translations-raw huggingface dataset:
The residue data presented for powders for use in drinking water do not call into question the withdrawal periods approved for each product individually at the dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days. 
Predočeni podatci o reziduama za praškove za primjenu u vodi za piće ne dovode u pitanje razdoblja karencije odobrena za svaki pojedini proizvod pri dozi od 16,65 mg linkomicina i 33,35 mg spektinomicina/kg tjelesne težine/dan tijekom 7 dana.
Chickens: 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days. 
Pilići: 16,65 mg linkomicina i 33,35 mg spektinomicina/kg tjelesne težine/dan tijekom 7 dana.
In E. coli and Salmonella, based on in vitro data, spectinomycin resistance rates of about 30-50% can be expected. 
To su prije svega bakterije Escherichia coli, Salmonella spp. i Campylobacter spp. Na temelju in vitro podataka, u bakterijama E. coli i Salmonella mogu se očekivati stope rezistencije od otprilike 30 - 50 %.
The presence of the disease in the flock must be established before the product is used. 
Prije primjene proizvoda mora se utvrditi prisutnost bolesti u jatu.
More generally, treatment with premixes for medicated feeding stuff and oral powders to be administered with the feed to pigs containing the combination lincomycinspectinomycin as currently recommended exposes the target pathogens and other bacteria to low doses for prolonged periods, which increases risk of resistance selection. 
Općenitije govoreći, liječenje premiksima za hranu za životinje s dodatkom lijekova i prašcima za peroralnu primjenu s hranom za svinje koji sadrže trenutačno preporučenu kombinaciju linkomicina i spektinomicina izlaže ciljane patogene i druge bakterije malim dozama u duljim razdobljima što povećava rizik od odabira rezistencije.
Zoetis France 23-25 Avenue du Docteur 
Zoetis France 23-25 Avenue du Docteur Lannelongue 75014 Paris France
The available clinical data show that the combination, administered in the drinking water at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days (i.e. the harmonised dose for Linco-Spectin 100), is clinically effective in treating mixed infections involving B. hyodysenteriae and other enteric pathogens targeted by spectinomycin, and that in those situations it is superior to the individual substances. 
Dostupni klinički podatci pokazuju da je ova kombinacija, primijenjena u vodi za piće u dozi od 3,33 mg linkomicina i 6,67 mg spektinomicina/kg tjelesne težine/dan tijekom 7 dana (odnosno, usklađenoj dozi za VMP Linco-Spectin 100), klinički učinkovita u liječenju mješovitih infekcija koje uključuju bakteriju B. hyodysenteriae i druge crijevne patogene koje se liječe spektinomicinom te da je u tim slučajevima primjena kombinacije nadređena primjeni tvari pojedinačno.
• the CVMP considered that the use of powders to be administered with the feed containing a combination of lincomycin and spectinomycin is not supported by data and the currently recommended dosing regimens entails a higher risk of selection and development of resistance due to exposition to low antimicrobial levels for prolonged periods. 
• CVMP je smatrao da primjena praškova za primjenu u hrani za životinje koji sadrže kombinaciju linkomicina i spektinomicina nije poduprta odgovarajućim podatcima te da trenutačno preporučeni režimi doziranja predstavljaju veći rizik od odabira i razvoja rezistencije zbog izloženosti niskim antimikrobnim razinama tijekom duljih razdoblja.
• the CVMP considered that the use of premixes for medicated feeding stuff containing a combination of lincomycin and spectinomycin is supported by inadequate clinical data and the currently recommended dosing regimens entails a higher risk of selection and development of resistance due to exposition to low antimicrobial levels for prolonged periods. 
• CVMP je smatrao da je primjena premiksa za hranu za životinje s dodatkom lijekova koji sadrže kombinaciju linkomicina i spektinomicina poduprta neodgovarajućim kliničkim podatcima te da trenutačno preporučeni režimi doziranja predstavljaju veći rizik od odabira i razvoja rezistencije zbog izloženosti niskim antimikrobnim razinama tijekom duljih razdoblja.
LINCOTRIMEX-PREMIX Lincomycin and Spectinomycin 
LINCOTRIMEX-PREMIX Linkomicin i spektinomicin
The residue data presented for powders for use in drinking water do not call into question the withdrawal periods approved for each product individually at the dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days. 
Predočeni podatci o reziduama za praškove za primjenu u vodi za piće ne dovode u pitanje razdoblja karencije odobrena za svaki pojedini proizvod pri dozi od 3,33 mg linkomicina i 6,67 mg spektinomicina/kg tjelesne težine/dan tijekom 7 dana.
Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and mycoplasmas. 
Linkomicin djeluje protiv gram-pozitivnih bakterija, nekih anaerobnih gram-negativnih bakterija i mikoplazmi.
Therefore, based on the activity spectrum of the combination, on general considerations of the pathogenesis of porcine proliferative enteropathy and on the available clinical data, it is considered that the indication for the treatment and prevention of porcine proliferative enteropathy (ileitis) caused by L. intracellularis, and associated enteric pathogens (E. coli) at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days in drinking water, approved during the Article 34 referral procedure (EMEA/V/A/088) for Linco-Spectin 100, is justified. 
Stoga se na temelju spektra djelatnosti ove kombinacije, općih razmatranja o patogenezi svinjske proliferativne enteropatije i dostupnih kliničkih podataka smatra da je indikacija za liječenje i sprečavanje svinjske proliferativne enteropatije (ileitisa) uzrokovane bakterijom L. intracellularis i povezanim crijevnim patogenima (E. coli) u dozi od 3,33 mg linkomicina i 6,67 mg spektinomicina/kg tjelesne težine/dan tijekom 7 dana u vodi za piće, odobrena u okviru postupka upućivanja sukladno članku 34. (EMEA/V/A/088) za VMP Linco-Spectin 100, opravdana.
One monocentric study concerning in-feed use is presented, which shows a beneficial effect in case of porcine proliferative enteropathy, but this uses lincomycin alone at a high dose in comparison to those used in the combination. 
Predočeno je jedno monocentrično ispitivanje u kojem se ispitivala uporaba hrane za životinje, a koje ukazuje na blagotvoran učinak u slučaju svinjske proliferativne enteropatije.
Based primarily on the latter experimental study, it is considered that the indication relating to chicken chronic respiratory disease (CRD) caused by M. gallisepticum and E. coli and associated with a low mortality rate, and the associated dosing regimen of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days, as approved during the Article 34 referral procedure (EMEA/V/A/088) for Linco-Spectin 100, are justified as the only validated indication and dosage in chickens. 
Smatra se, prvenstveno na temelju potonjeg eksperimentalnog ispitivanja, da su indikacija koja se odnosi na kroničnu respiratornu bolest pilića (CRD) uzrokovanu bakterijama M. gallisepticum i E. coli koja se povezuje s niskom stopom smrtnosti i povezani režim doziranja pri kojem se daje 16,65 mg linkomicina i 33,35 mg spektinomicina/kg tjelesne težine (50 mg kombiniranih djelatnih tvari/kg tjelesne težine) na dan tijekom 7 dana, kako je odobreno u okviru postupka upućivanja sukladno članku 34. (EMEA/V/A/088) za VMP Linco-Spectin 100, opravdani kao jedina provjerena indikacija i jedino provjereno doziranje u pilića.
In E. coli, a significant part of the strains show high MIC values (minimum inhibitory concentrations) against the lincomycin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined. 
U znatnom broju sojeva E. coli utvrđene su visoke vrijednosti MIK-a (minimalnih inhibitornih koncentracija) pri primjeni kombinacije linkomicina i spektinomicina.
Pigs, poultry 
Svinje, pilići
Powder to be administered with the feed 
Prašak koji se primjenjuje s hranom za životinje
The use of premixes for medicated feeding stuff or powders to be administered with the feed containing a combination of lincomycin and spectinomycin is currently recommended at relatively low doses and for prolonged periods, which infers use for growth promotion. 
Primjena premiksa za hranu za životinje s dodatkom lijekova ili praškova za primjenu s hranom za životinje koji sadrže kombinaciju linkomicina i spektinomicina trenutačno se preporučuje u razmjerno malim dozama i tijekom duljih razdoblja, što podrazumijeva primjenu za poticanje rasta.
Pigs, hens pigeons, ducks, turkeys 
Svinje, kokoši golubovi, patke, purani
In chickens, powders for use in drinking water containing a combination of lincomycin and spectinomycin at a dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days is considered effective in cases of CRD caused by M. gallisepticum and E. coli, and associated with a low mortality rate. 
U pilića se primjena praškova u vodi za piće koji sadrže kombinaciju linkomicina i spektinomicina u dozi od 16,65 mg linkomicina i 33,35 mg spektinomicina/kg tjelesne težine (50 mg kombiniranih djelatnih tvari/kg tjelesne težine) na dan tijekom 7 dana smatra učinkovitom u slučajevima kronične respiratorne bolesti uzrokovane bakterijama M. gallisepticum i E. coli te je povezana s niskom stopom smrtnosti.
D-30625 Hannover Germany 
Kon-Pharma GmbH Senator-Bauer-Str. 34 D-30625 Hannover Germany
Zone D'Activites Du Bois De Teillay 35150 Janze France 
Zone D'Activites Du Bois De Teillay
Concerning powders for use in drinking water containing a combination of lincomycin and spectinomycin to be administered orally to pigs at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw (10 mg combined actives/kg bw) per day for 7 days is considered effective in cases of porcine proliferative enteropathy caused by L. intracellularis, and possible associated pathogens among which is E. coli. 
Primjena praškova u vodi za piće koji sadrže kombinaciju linkomicina i spektinomicina za peroralnu primjenu u svinja u dozi od 3,33 mg linkomicina i 6,67 mg spektinomicina/kg tjelesne težine (10 mg kombiniranih djelatnih tvari/kg tjelesne težine) na dan tijekom 7 dana smatra se učinkovitom u slučajevima svinjske proliferativne enteropatije uzrokovane bakterijom L. intracellularis i mogućim povezanim patogenima, među kojima je E. coli.
Ramsgate Road Sandwich, Kent CT13 9NJ 
CT13 9NJ
200 Avenue de Mayenne Zone Industrielle des Touches 53000 Laval France 
200 Avenue de Mayenne
In Campylobacter, variable but possibly high resistance rates were shown against lincomycin; however the situation could be more complex because those bacteria are also considered susceptible to spectinomycin, for which few data are available. 
Međutim, problem bi mogao biti složeniji jer se te bakterije također smatraju osjetljivima na spektinomicin za koji je dostupno malo podataka.
Pigs, chickens (broilers) 
Svinje, pilići (tovni)
Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp. 
Spektinomicin je aminociklitolni antibiotik koji se dobiva iz bakterije Streptomyces spectabilis.
Pigs, poultry (broiler, pullet) and turkey 
Svinje, perad (tovna, mlade kokoši) i purani
2 under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs, the CVMP recommended the indication ‘swine dysentery caused by B. hyodysenteriae' to be deleted from the http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_cont aining_tylosin_to_be_administered_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp&mid=WC0b01 ac05805c5170 
2http://www.ema.europa.eu/em a/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_containing_tylosin_to_be_administe red_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp&mid=WC0b01ac05805c5170
Delete, where applicable, any references to any poultry species other than chickens. 
Potrebno je izbrisati sva upućivanja na sve vrste peradi osim pilića kada je to primjenjivo.
Linco-Spectin 44 Premix Lincomycin and Spectinomycin 
Linco-Spectin 44 Premix Linkomicin i spektinomicin
Most available clinical efficacy data relate to administration of the combination as powder for use in drinking water; those from the basis for the harmonised dosing regimen of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days for Linco-Spectin 100, as approved during the Article 34 referral procedure (EMEA/V/A/088). 
Na osnovi tih podataka utvrđen je usklađeni režim doziranja za VMP Linco-Spectin 100 prema kojem se daje doza od 3,33 mg linkomicina i 6,67 mg spektinomicina/kg tjelesne težine/dan tijekom 7 dana kako je odobreno u okviru postupka upućivanja sukladno članku 34. (EMEA/V/A/088).
Floridsdorfer Hauptstrasse 1 1210 Wien Austria 
Zoetis Österreich GmbH Floridsdorfer Hauptstrasse 1
Linko-spectin 44 premix Lincomycin and Spectinomycin 
Linko-spectin 44 premix Linkomicin i spektinomicin
In E. coli the MIC distribution appears to be bimodal, with a significant number of strains showing high MIC values; this could partly correspond to natural (intrinsic) resistance. 
Čini se da je raspodjela MIK-a za E. coli bimodalna, pri čemu znatan broj sojeva pokazuje visoke vrijednosti MIK-a.
16,65 g/100 g 
16,65 g/100 g 33,35 g/100 g
Piglets, calves, chickens 
Prasad, telad, pilići
Calves, piglets, chickens 
Telad, prasad, pilići
Pigs, chickens, turkeys 
Svinje, pilići, purani
Lincospectin 44 mg/g 
Lincospectin 44 mg/g Linkomicin i spektinomicin
Schellingstrasse 1 
Ramsgate Road
PYANOSID, geriamieji milteliai g/146,36 g g/146,36 g 
66,7 g/146,36 g
Dublin 1 
1210 Wien
and against some gram-negative bacteria such as E. coli. 
Djeluje bakteriostatski i djelotvoran je protiv bakterije Mycoplasma spp i nekih gram-negativnih bakterija kao što je E. coli.
End of February 
Kraj veljače
# median (min-max) 
# medijan (min-maks)
However, the clinical relevance of these findings is unknown. 
Međutim, klinička važnost tih nalaza nije poznata.
Macrophages are considered the main target organ. 
Makrofazi se smatraju glavnim ciljnim organom.
PAI-2 is known to be uniquely up-regulated in the placenta. 
Poznato je da se PAI-2 regulira naviše (up-regulation) samo u placenti.
As you will be given this medicine by a doctor or a nurse it is unlikely that a dose will be missed. 
Budući da će Vam ovaj lijek davati liječnik ili medicinska sestra, nije vjerojatno da će doza biti propuštena.
• if you are undergoing surgery 
• ako ćete se podvrgnuti kirurškom zahvatu
Safety information in children are available from the prevention study conducted solely in children. 
Podaci o sigurnosti u djece dostupni su iz ispitivanja prevencije provedenog samo u djece.
• if you are taking medicine that increases the risk of bleeding 
• ako uzimate lijekove koji povećavaju rizik od krvarenja
Contents of the pack and other information. 
Sadržaj pakiranja i druge informacije
Data derived from an independent US registry have shown a beneficial effect of Defitelio in routine clinical practice. 
Podaci dobiveni iz nezavisnog registra Sjedinjenih Država pokazali su koristan učinak lijeka Defitelio u rutinskoj kliničkoj praksi.
This is called an ‘intravenous infusion' or drip. 
To se naziva intravenska infuzija ili drip.
Date of latest renewal: 26 July 2018 
Datum posljednje obnove odobrenja: 26. srpnja 2018
• if you have heavy bleeding and need a blood transfusion 
• ako imate teško krvarenje i potrebna Vam je transfuzija krvi
Updated analysis from CIBMTR to be submitted by end of December 2020. 
CIBMTR-a treba biti dostavljena do kraja prosinca
You must not be given a double dose to make up for a missed dose. 
Ne smije Vam se primijeniti dvostruka doza kako bi se nadoknadila zaboravljena doza.
However, the exact mechanism of action of defibrotide is not fully elucidated. 
Međutim, točan mehanizam djelovanja defibrotida nije u potpunosti razjašnjen.
• severe allergic reaction (you might experience swelling of the hands, face, lips, tongue or throat, 
• teška alergijska reakcija (možete osjetiti oticanje šaka, lica, usana, jezika ili grla, teškoće pri disanju).
Side effects in children (1 month to 18 years old) are expected to be similar in type, severity and frequency and no other special precautions are needed. 
Očekuje se da će nuspojave u djece (od 1 mjeseca do 18 godina) biti sličnog tipa, težine i učestalosti i nikakve druge posebne mjere opreza nisu potrebne.
22079 Italy 
22079 Italija
You will receive this treatment four times a day for at least 21 days or until your symptoms resolve. 
Lijek ćete primati četiri puta na dan tijekom najmanje 21 dana ili dok ne dođe do povlačenja simptoma.
• if you have problems with blood circulation because your body cannot maintain a constant blood pressure. 
• ako imate tegoba s cirkulacijom jer Vaš organizam ne može održavati stabilni krvni tlak.
In the treatment studies over 50% of the patients were children. 
U ispitivanjima liječenja, više od 50% bolesnika bila su djeca.
• if you are allergic to defibrotide or any of the other ingredients of this medicine (listed in section 6) 
• ako ste alergični na defibrotid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
However there was no difference in incidence of serious bleeding or bleeding events with fatal outcome. 
Međutim, nije bilo razlike u incidenciji ozbiljnog krvarenja ili krvarenja sa smrtnim ishodom.
The mechanism of action is multifactorial. 
Mehanizam djelovanja je višestruk.
Due to this maternal toxicity, no conclusion can be drawn regarding the effects of defibrotide on embryo-foetal development. 
Zbog te maternalne toksičnosti ne može se donijeti zaključak o učincima defibrotida na embriofetalni razvoj.
No special precautions are indicated. 
Nisu indicirane posebne mjere opreza.
It will be slowly injected (over a 2-hour period) into one of your veins. 
Lijek ćete primati polako (u trajanju od 2 sata) u jednu od vena.
There is limited efficacy and safety data on doses above this level and consequently it is not recommended to increase the dose above 25 mg/kg/day. 
O djelotvornosti i sigurnosti doza iznad te granice postoje ograničeni podaci, i stoga se ne preporučuje povećavati dozu iznad 25 mg/kg na dan.
Considering the nature of the medicinal product, a risk to the newborns/infants is not expected. 
S obzirom na karakteristike lijeka, ne očekuje se rizik za novorođenčad/dojenčad.
The recommended dose in children from one month to 18 years of age is the same as in adults. 
Preporučena doza za djecu od 1 mjeseca do 18 godina jednaka je kao u odraslih.
What Defitelio is and what it is used for 
Što je Defitelio i za što se koristi
Measure 1 
Mjera br. 1
In patients who have or develop clinically significant acute bleeding requiring blood transfusion, Defitelio is not recommended or should be discontinued. 
U bolesnika koji imaju ili razviju klinički značajno akutno krvarenje koje zahtijeva transfuziju krvi, Defitelio se ne preporučuje ili ga treba ukinuti.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/878/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/878/001
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). 
Učestalosti su definirane kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000).
− If you have any further questions, ask your doctor. 
Ako imate dodatnih pitanja, obratite se liječniku.
The report will also reflect on the safety data being collected during prophylactic treatment, and any potential safety differences related to the difference in indication (ie treatment vs prophylactic therapy). 
Izvješće će također odražavati podatke o sigurnosti koji se prikupljaju tijekom profilaktičke terapije, kao i sve potencijalne razlike u sigurnosti s obzirom na razliku u indikaciji (tj. liječenje naspram profilaktičke terapije).
4.5 Interaction with other medicinal products and other forms of interaction Potential interactions with recombinant t-PA 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Potencijalne interakcije s rekombinantnim t-PA
*=Kaplan Meier estimates for time-to-event analysis by Day100 
*=Kaplan Meierove procjene za analizu vremena do razvoja događaja do dana +100
• if you are using other medicines to break down blood clots such as tissue plasminogen activator 
• ako uzimate druge lijekove za razgradnju krvnih ugrušaka kao što je tkivni aktivator plazminogena.
These data are from an open label registry and the subjects were not randomised. 
To su podaci iz otvorenog registra i ispitanici nisu bili randomizirani.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenicity. 
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti ili kancerogenosti.
Measure 2 In order to provide comparative data on efficacy, the MAH will submit 
Mjera br. 2 U svrhu dostavljanja usporednih podataka o djelotvornosti, nositelj odobrenja će predati
Consideration should be given to discontinuation of Defitelio during use of such therapy. 
Treba razmotriti obustavu primjene lijeka Defitelio za vrijeme takve terapije.
If particles are observed and/or the liquid in the vial is not clear, the vial must not be used. 
Ako se opaze čestice i/ili tekućina u bočici nije bistra, bočica se ne smije upotrijebiti.
Table 1: Treatment Study Results: Complete Response and Survival Rate of Severe VOD at Day+100 
Tablica 1: Rezultati ispitivanja liječenja: potpuni odgovor i stopa preživljenja kod teške veno-okluzivne bolesti na dan+100
Median length of therapy in those treated with Defitelio was 22 days. 
Medijan trajanja liječenja u bolesnika liječenih lijekom Defitelio bio je 22 dana.
Summary of the Safety Profile 
Sažetak profila sigurnosti
OTHER 200 mg/2.5 mL Gentium Srl 
DRUGO 200 mg/2.5 mL Gentium Srl
If you are sexually active and you or your partner could become pregnant, you both must use effective contraception during treatment with Defitelio and for 1 week after stopping the treatment. 
Ako ste spolno aktivni i postoji mogućnost trudnoće, Vaše ili Vaše partnerice, oboje morate upotrebljavati učinkovitu kontracepciju tijekom liječenja lijekom Defitelio i još 1 tjedan nakon prestanka liječenja.
This can be caused by medicines that are given prior to a stem cell transplantation. 
Do toga može doći zbog lijekova koji se uzimaju prije transplantacije matičnih stanica.
Pharmacotherapeutic group: other antithrombotic agents; ATC code: B01AX01. 
Farmakoterapijska skupina: drugi antitrombotski lijekovi; ATK oznaka: B01AX01
Historical Control 
Povijesna kontrolna skupina
There is no specific antidote for overdose and treatment should be symptomatic. 
U slučaju predoziranja nema posebnog antidota i liječenje treba biti simptomatsko.
Other medicines and Defitelio 
Drugi lijekovi i Defitelio
Talk to your doctor before using Defitelio: 
Obratite se svom liječniku prije nego primijenite Defitelio:
• coagulopathy (disturbance of blood clotting) 
• koagulopatija (poremećaj zgrušavanja krvi)
Defitelio should always be diluted prior to use. 
Defitelio se mora uvijek razrijediti prije primjene.
Marketing Authorisation Holder and Manufacturer Gentium Srl 
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Gentium Srl
What you need to know before you take Defitelio 
Što morate znati prije nego počnete primjenjivati Defitelio
It is administered by intravenous infusion, over two hours. 
Primjenjuje se intravenskom infuzijom tijekom dva sata.