natgillin/translations-raw huggingface dataset:
Clinical studies in treatment-naïve or treatment-experienced subjects with or without cirrhosis Of the 2,409 subjects with compensated liver disease (with or without cirrhosis) treated who were treatment-naïve or treatment-experienced to combinations of peginterferon, ribavirin and/or sofosbuvir, the median age was 53 years (range: 19 to 88); 73.3% were treatment-naïve, 26.7% were treatment-experienced to a combination containing either sofosbuvir, ribavirin and/or peginterferon; 40.3% were HCV genotype 1; 19.8% were HCV genotype 2; 27.8% were HCV genotype 3; 8.1% were HCV genotype 4; 3.4% were HCV genotype 5-6; 13.1% were ≥65 years; 56.6% were male; 6.2% were Black; 12.3% had cirrhosis; 4.3% had severe renal impairment or end stage renal disease; 20.0% had a body mass index of at least 30 kg per m2; 7.7% had HIV-1 coinfection and the median baseline HCV RNA level was 6.2 log10 IU/mL 
imalo je HCV infekciju genotipa 1; 19,8% imalo je HCV infekciju genotipa 2; 27,8% imalo je HCV infekciju genotipa 3; 8,1% imalo je HCV infekciju genotipa 4; 3,4% imalo je HCV infekciju genotipa 5-6; 13,1% imalo je ≥ 65 godina; 56,6% bili su muškarci; 6,2% bili su crnci; 12,3% imalo je cirozu; 4,3% imalo je teško oštećenje bubrežne funkcije ili je bilo u terminalnoj fazi bubrežne bolesti;
The following adverse reactions were identified in patients treated with Maviret. 
U bolesnika liječenih lijekom Maviret utvrđene su sljedeće nuspojave.
All subjects without cirrhosis or with compensated cirrhosis received 8 or 12 weeks of Maviret, respectively, except GT3 TE-PRS subjects who received 16 weeks of Maviret. 
odnosno 12 tjedana, osim ispitanika s genotipom 3 koji su prethodno bili liječeni PRS-om, a koji su lijek Maviret primali tijekom 16 tjedana.
b. GT2 from SURVEYOR-2 Parts 1 and 2 - Maviret for 8 weeks (n=54) or 12 weeks (n=25); GT2 from SURVEYOR-2 Part 4 - Maviret for 8 weeks (n=145). 
Uključuje 33 ispitanika s istodobnom HIV-1 infekcijom b. Ispitanici s genotipom 2 iz 1. i 2. dijela ispitivanja SURVEYOR-2 - Maviret tijekom 8 tjedana (n=54) ili 12 tjedana (n=25); ispitanici s genotipom 2 iz 4. dijela ispitivanja SURVEYOR-2 - Maviret tijekom 8 tjedana (n=145).
Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor 
NS3/4A proteaze i/ili inhibitorima NS5A
A low dose of the statin is recommended at the initiation of the DAA treatment. 
Na početku liječenja direktno djelujućim antiviroticima preporučuje se primjena niske doze.
Tablet core 
Tablični prikaz nuspojava
Some combinations of NS5A 
NS5A i/ili NS3/4A
One GT3b TN subject experienced relapse. 
Jedan ispitanik s infekcijom genotipom 3b koji prethodno nije bio liječen doživio je relaps.
Clinical Study in Subjects with Genotype 5 or 6 Infection ENDURANCE-5,6 was an open-label study in 84 HCV GT5 (N=23) or 6-infected (N=61) TN or TEPRS subjects. 
Ispitivanje ENDURANCE-5,6 bilo je otvoreno ispitivanje provedeno u 84 ispitanika s HCV
Patients with HIV-1 Co-infection 
ANTIVIROTICI ZA LIJEČENJE HCV INFEKCIJE
Of the 101 subjects treated, the median age was 58 years (range 32-87); 53% had HCV genotype 1; 27% had HCV genotype 2; 15% had HCV genotype 3; 4% had HCV genotype 4; 59% were male; 73% were White; 80% were HCV treatment-naïve; 13% had cirrhosis and 65% had a baseline fibrosis state of F0 or F1; 7% were CKD stage 3b; 17% were CKD Stage 4, and 76% were CKD Stage 5 (all receiving dialysis); 84 subjects received 8 weeks of treatment, 13 subjects received 12 weeks of treatment, and 4 subjects received 16 weeks of treatment. 
Među 101 liječenim ispitanikom, medijan dobi iznosio je 58 godina (raspon 32-87); 53% imalo je HCV infekciju genotipa 1; 27% imalo je HCV infekciju genotipa 2; 15% imalo je HCV infekciju genotipa 3; 4% imalo je HCV infekciju genotipa 4; 59% bili su muškarci; 73% bili su bijelci; 80%
50 mg single dose 
50 mg
100 mg single dose 
Ciklosporin jednokratna doza od 100 mg
Of the 100 subjects treated, the median age was 60 years (range: 39 to 78); 57% had HCV genotype 1, 13% had HCV genotype 2, 24% had HCV genotype 3, 4% had HCV genotype 4, 2% had HCV genotype 6; 75% were male; 8% were Black; 66% were HCV treatment-naïve; none had cirrhosis and 80% had a baseline fibrosis state of F0 or F1; 80% of subjects were post-liver transplant and 20% were post-kidney transplant. 
HCV infekciju genotipa 1; 13% imalo je HCV infekciju genotipa 2; 24% imalo je HCV infekciju genotipa 3; 4% imalo je HCV infekciju genotipa 4; 2% imalo je HCV infekciju genotipa 6; 75% bili su muškarci; 8% bili su crnci; 66% prethodno nije primilo liječenje za HCV; nijedan nije imao cirozu, a
• diarrhoea 
• mučnina
Vitamin E (tocopherol) polyethylene glycol succinate Silica, colloidal anhydrous 
Jezgra tablete kopovidon (tip K 28) vitamin E (tokoferol) polietilenglikolsukcinat silicijev dioksid, koloidni, bezvodni propilenglikolmonokaprilat (tip II) karmelozanatrij, umrežena natrijev stearilfumarat
Elderly 
Ostalob
IMMUNOSUPPRESSANTS Ciclosporin 
IMUNOSUPRESIVI
METHOD AND ROUTE OF ADMINISTRATION 
OZNAČIVANJE I UPUTA O LIJEKU
Due date 
2. tromjesečje
However, in some cases this does not happen. 
Međutim, u nekim slučajevima se to ne dogodi.
• Risk Management Plan (RMP) Not applicable. 
• Plan upravljanja rizikom (RMP) Nije primjenjivo.
* see below 
* vidjeti niže
These measures will help to protect the environment. 
Ove će mjere pomoći u zaštiti okoliša.
The following information is intended for medical or healthcare professionals only: 
Sljedeće informacije namijenjene su samo liječnicima i zdravstvenim radnicima:
All patients recovered with conventional treatment. 
Svi bolesnici su se oporavili uz uobičajenu terapiju.
It may harm them, even if their symptoms are the same as your baby's. 
Može im štetiti, čak i ako imaju simptome jednake kao Vaše dijete.
The first injection should be given after the first 6 hours of life. 
Prvu injekciju treba dati nakon prvih 6 sati života.
This leaflet was last approved in 
Ova uputa je zadnji puta revidirana u
Not relevant 
Nije primjenjivo.
Date of first authorisation: 29 July 2004 Date of renewal: 29 July 2009 
Datum prvog odobrenja: 29. srpnja 2004.
- Pedea should not be given in the first 6 hours of life. 
- Pedea se ne smije primijeniti tijekom prvih 6 sati života.
This medicine has been prescribed for your baby. 
- Ovaj je lijek propisan Vašem djetetu.
Pedea must therefore be used cautiously in the presence of an infection (see also section 4.3). 
Pedea se stoga u prisustvu infekcije mora primijeniti s oprezom (također vidjeti dio 4.3).
To avoid any possible microbiological contamination, the product should be used immediately after first opening. 
Da bi se izbjegla moguća mikrobiološka kontaminacija, lijek treba primijeniti odmah nakon prvog otvaranja.
If you have further questions, please ask your doctor or your pharmacist. 
- Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
Please tell your doctor or pharmacist if your baby is taking or has recently taken any other medicines, including medicines obtained without a prescription. 
Obavijestite svog liječnika ili ljekarnika o svim lijekovima koje Vaše dijete uzima ili je nedavno uzimalo, uključujući i one koji se izdaju bez recepta.
After opening, Pedea should be administered immediately. 
Nakon otvaranja, Pedeu treba odmah primijeniti.
In vivo and in vitro studies indicate that the S(+) isomer is responsible for the clinical activity. 
In vivo i in vitro studije pokazale su da je S(+) izomer odgovoran za kliničku aktivnost.
The apparent volume of distribution is on average 200 ml/kg (62 to 350 according to various studies). 
Prividni volumen distribucije je 200 ml/kg (62 do 350 prema različitim ispitivanjima).
This can cause heart problems in your baby. 
On može izazvati srčane tegobe u Vašeg djeteta.
These are detailed below: 
Opisane su detaljno u nastavku:
Posology and method of administration (see also section 3) 
Doziranje i način primjene (vidjeti također dio 3)
Pharmacotherapeutic group: other cardiac preparations, ATC code: C01 EB16 
Farmakoterapijska skupina: ostali pripravci s učinkom na srce, ATK oznaka: C01 EB16
Ibuprofen is a racemic mixture of S(+) and R(-) enantiomers. 
Ibuprofen je racemična smjesa S(+) i R(-) enantiomera.
With the exception of an acute toxicity study, no further studies have been carried out in juvenile animals with Pedea. 
Izuzev ispitivanja akutne toksičnosti, nisu provedena druga ispitivanja s Pedeom na mladim životinjama.
To facilitate the administration an infusion pump may be used. 
Da bi se olakšala primjena može se koristiti pumpa za infuziju.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenom na europskom internetskom portalu za lijekove.
What Pedea contains 
Što Pedea sadrži
The central volume of distribution may depend on the status of the ductus and decrease as the ductus closes. 
Središnji volumen distribucije može ovisiti o statusu duktusa i opadati kako se duktus zatvara.
Elimination rate is markedly lower than in older children and adults, with an elimination half-life estimated at approximately 30 hours (16-43). 
Brzina eliminacije je značajno niža u odnosu na izlučivanje u starije djece i odraslih, s procijenjenim poluvremenom eliminacije od približno 30 sati (16-43).
A rinse of the infusion line must be performed between each product administration (see section 6.6). 
Infuzijska linija se mora isprati između svake primjene lijeka (vidjeti dio 6.6).
WHAT PEDEA IS AND WHAT IT IS USED FOR 
ŠTO JE PEDEA I ZA ŠTO SE KORISTI
The management of ibuprofen overdose is primarily supportive. 
Liječenje predoziranja ibuprofenom je prvenstveno potporno.
While a baby is inside its mother's womb it does not need to use its lungs. 
Dok je dijete u maternici ne treba koristiti svoja pluća.
When the baby is born and starts using its lungs the ductus arteriosus normally closes. 
Kada se dijete rodi i počne koristiti vlastita pluća, arterijski duktus se normalno zatvori.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data) 
Učestalost mogućih nuspojava navedenih ispod, definirane su prema sljedećem dogovoru: vrlo često (pojavljuju se u više od 1 na 10 korisnika) često (pojavljuju se u 1 do 10 na 100 korisnika) manje često (pojavljuju se u 1 do 10 na 1000 korisnika) vrlo rijetko (pojavljuju se u manje od 1 na 10 000 korisnika) nije poznato (učestalost se ne može procijeniti iz dostupnih podataka)
If hypoxaemia occurs during or following Pedea infusion, close attention should be paid to pulmonary pressure. 
Ako se hipoksemija pojavi tijekom ili nakon infuzije Pedee, posebnu pažnju treba obratiti na plućni tlak.
Plasma concentrations of the S-enantiomer are much higher than those of the R-enantiomer, which reflects a rapid chiral inversion of the R- to the S-form in a proportion similar to adults (about 60%). 
Koncentracije S-enantiomera u plazmi mnogo su više od koncentracija R-enantiomera, što odražava brzu kiralnu inverziju R- u S-formu u omjerima sličnim onima u odraslih (oko 60%).
Like all medicines, Pedea can cause side effects, although not everybody gets them. 
Kao i svi lijekovi, Pedea može uzrokovati nuspojave, iako se neće pojaviti u svakoga.
- If your baby is suspected of having liver disease, signs and symptoms of which include yellowing of the skin and eyes. 
Ako se u Vašeg djeteta posumnja na bolest jetre, a simptomi koji mogu upućivati na to su žuta boja kože i očiju.
Frequencies are defined as: very common (≥ 1/10), common (≥1/100, <1/10) and uncommon (≥1/1,000, <1/100). 
Učestalost je definirana prema sljedećim pravilima: vrlo česta (≥ 1/10), česta (≥1/100 i <1/10) te manje česta (≥1/1000 i <1/100).
Take special care with Pedea - Before treatment with Pedea, your baby's heart will be examined to confirm that the ductus arteriosus is open. 
Budite posebno oprezni s Pedeom - Prije primjene Pedee, srce Vašeg djeteta pregledat će se da se potvrdi postojanje otvorenog arterijskog duktusa.
Only one recorded death has been published: after an overdose of 469 mg/kg, a 16-month old child developed an apnoeic episode with seizures and a fatal aspiration pneumonia. 
Zabilježen je samo jedan smrtni slučaj: nakon predoziranja s 469 mg/kg, 16-mjesečno dijete je razvilo apneju s napadajima te aspiracijsku pneumoniju sa smrtnim ishodom.
A maximal volume of 80 ml/kg/day on the first day of life should usually be respected; this should be progressively increased in the following 1-2 weeks (about 20 ml/kg birthweight/day) up to a maximal volume of 180 ml/kg birthweight/day. 
Obično treba poštovati pravilo da se na prvi dan života djeteta primijeni najviše 80 ml/kg/dan tekućine; taj volumen treba postupno povećavati tijekom idućih 1-2 tjedna (oko 20 ml/kg porođajne težine/dan) do maksimalno 180 ml/kg porođajne težine/dan.
For intravenous use only. 
Samo za intravensku primjenu.
- Pedea may be less effective in very premature babies less than 27 weeks of gestational age. 
- Pedea može biti manje učinkovita u djece koja su rođena prije 27 tjedana trudnoće.
- your baby may be given nitric oxide to improve blood oxygenation. 
- Vaše dijete može primati dušični oksid da bi se poboljšala oksigenacija krvi.
Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the Pedea solution. 
Klorheksidin se ne smije upotrijebiti za dezinfekciju vrata ampule jer nije kompatibilan s otopinom Pedee.
Certain medicines, if given together with Pedea, may cause side effects. 
Pojedini lijekovi, primijenjeni zajedno s Pedeom, mogu izazvati nuspojave.
An unborn baby has a blood vessel called the ductus arteriosus near the heart which allows the baby's blood to bypass the lungs and circulate to the rest of the body. 
Nerođeno dijete ima blizu srca krvnu žilu koja se zove arterijski duktus i omogućava djetetovoj krvi da zaobilazi pluća i cirkulira ostatkom tijela.
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included. 
JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
As a non-steroidal anti-inflammatory drug (NSAID), ibuprofen may mask the usual signs and symptoms of infection. 
Kao nesteroidni protuupalni lijek (NSAIL), ibuprofen može prikriti uobičajene znakove i simptome infekcije.
If this is significant, your baby's treatment may be stopped until the volume of urine returns to normal. 
Ako je to značajno, liječenje djeteta može biti prekinuto dok se volumen izlučene mokraće ne vrati u normalne granice.
Ibuprofen may reduce the effect of these medicines. 
Ibuprofen može smanjiti učinak tih lijekova.
Keep out of reach and sight of children. 
Čuvati izvan dohvata i pogleda djece.
Data are currently available on approximately 1,000 preterm newborn from both the literature concerning ibuprofen and clinical trials with Pedea. 
Trenutno su dostupni podaci o oko 1000 nedonoščadi što iz literature što iz kliničkih ispitivanja s Pedeom.
Residual concentrations are around 1015 mg/l 24 hours after the last dose of 5 mg/kg. 
Ostatne koncentracije su oko 10-15 mg/l 24 sata nakon zadnje doze od 5 mg/kg.
If anuria or manifest oliguria occurs after the first or second dose, the next dose should be withheld until urine output returns to normal levels. 
Ako se nakon prve ili druge doze pojave anurija ili manifestna oligurija, s idućom dozom treba pričekati dok se izlučivanje mokraće ne vrati na normalne vrijednosti.
There are no preclinical data considered relevant to clinical safety beyond data included in other sections of this Summary of Product Characteristics. 
Nema drugih relevantnih pretkliničkih podataka o sigurnosti primjene osim onih koji su već uključeni u druge odjeljke ovog Sažetka opisa svojstava lijeka.
Blood and lymphatic system disorders 
Poremećaji krvi i limfatičkog sustava
Any unused product or waste material should be disposed of in accordance with local requirements. 
Sav neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
The clearance of both enantiomers increases with gestational age, at least in the range of 24 to 28 weeks. 
Klirens oba enantiomera raste s gestacijskom dobi, barem između 24 do 28 tjedna.
However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease. 
Ipak, njih je teško razlikovati od čestih komplikacija koje se javljaju u nedonoščadi kao i od komplikacija same bolesti.
The medical term for this condition is ‘patent ductus arteriosus', i.e. an open ductus arteriosus. 
Medicinski pojam za ovo stanje je 'otvoreni arterijski duktus'.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Unutar svake skupine učestalosti, nuspojave su prikazane od ozbiljnijih prema manje ozbiljnima.
Pedea, when given to your baby, can help to close the ductus arteriosus. 
Kada se daje Vašem djetetu, Pedea može pomoći u zatvaranju arterijskog duktusa.
Although a great variability is observed in the premature population, peak plasma concentrations are measured around 35-40 mg/l after the initial loading dose of 10 mg/kg as well as after the last maintenance dose, whatever gestational and postnatal age. 
Iako je velika varijabilnost primjećena u populaciji nedonoščadi, vršna koncentracija u plazmi je izmjerena oko 35-40 mg/l nakon primjene prve doze od 10 mg/kg kao i nakon zadnje doze održavanja, bez obzira na gestacijsku i postnatalnu dob.
- Pedea may reduce the amount of urine your baby passes. 
- Pedea može smanjiti količinu mokraće Vašeg djeteta.
Pedea solution must not be in contact with any acidic solution such as certain antibiotics or diuretics. 
Otopina Pedee ne smije doći u kontakt s kiselim otopinama kao što su neki antibiotici i diuretici.
This condition is much more frequent in premature newborn than in full-term newborn infants. 
Ovo je stanje puno češće u nedonoščadi u odnosu na djecu rođenu u terminu.
Detailed information on this product is available on the web site of the European medicines Agency (EMEA) http://www.emea.europa.eu 
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
In vitro studies suggest that, similarly to other NSAIDs, ibuprofen is highly bound to plasma albumin, although this seems to be significantly lower (95 %) compared with adult plasma (99 %). 
ln vitro ispitivanja nagoviještaju da je, slično kao i ostali NSAIL, ibuprofen u visokoj mjeri vezan za albumin u plazmi, iako se čini da je to znatno manje (95 %) u usporedbi s vezanjem u plazmi odraslih
Careful monitoring of both renal and gastrointestinal function is recommended. 
Preporučuje se pažljivo praćenje bubrežne i probavne funkcije.
Not known: - Perforation of the stomach 
Nepoznato: - Perforacija (probušenje stijenke) želuca
Causality of adverse events reported in the preterm newborn is difficult to assess since they may be related to the haemodynamic consequences of the patent ductus arteriosus as well as to direct effects of ibuprofen. 
Uzročnu povezanost zabilježenih štetnih događaja u nedonoščadi teško je utvrditi s obzirom da oni mogu biti hemodinamske posljedice otvorenog arterijskog duktusa kao i izravni učinci ibuprofena.
- your baby may have problems passing urine and may have been prescribed diuretics. 
- Vaše dijete može imati problema s izlučivanjem mokraće i stoga mu mogu biti propisani diuretici.
Solution for injection 4 x 2 ml ampoules 
Otopina za injekciju 4 x 2 ml ampule
Do not use Pedea - if your baby is allergic (hypersensitive) to ibuprofen or any of the other ingredients of Pedea; - if your baby has a life-threatening infection which has not been treated; - if your baby is bleeding, especially if the bleeding is inside the skull or in the intestines; - if your baby has a decrease of blood cells called platelets (thrombocytopenia) or other problems with their blood clotting; - if your baby has kidney problems; - if your baby has other problems with their heart which require the ductus arteriosus to remain open so that adequate circulation of the blood is maintained; - if your baby has or is suspected to have certain problems with their intestines (a condition called necrotising enterocolitis); 
Nemojte primjenjivati Pedeu: - ako je Vaše dijete alergično (preosjetljivo) na ibuprofen ili na neki drugi sastojak Pedee; - ako Vaše dijete ima infekciju koja mu ugrožava život te koja se ne liječi; - ako Vaše dijete krvari, osobito ako je krvarenje unutar glave ili u crijevima; - ako Vaše dijete ima smanjeni broj krvnih pločica (trombocita) (trombocitopenija) ili drugih problema sa zgrušavanjem krvi; - ako Vaše dijete ima problema s bubrezima; - ako Vaše dijete ima drugih problema sa srcem koji zahtijevaju da arterijski duktus ostane otvoren kako bi se održala odgovarajuća cirkulacija krvi; - ako Vaše dijete ima ili se sumnja da ima određene probleme s crijevima (stanje koje se naziva nekrotizirajući enterokolitis);
Detailed information on this medicine is available on the European medicines Agency website: http://emea.europa.eu 
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
When disinfecting the neck of the ampoule with an antiseptic, to avoid any interaction with the Pedea solution, the ampoule must be completely dry before it is opened. 
Da bi se izbjegla interakcija s otopinom Pedeae pri dezinfekciji vrata ampule antiseptikom, ampula mora prije otvaranja biti potpuno suha.
This calculated amount will be given by infusion in a vein over a period of 15 minutes. 
Izračunata količina bit će primijenjena kao infuzija u venu tijekom 15 minuta.
Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity. 
Ibuprofen je NSAIL s protuupalnim, analgetskim i antipiretskim učinkom.
What Pedea looks like and contents of the pack Pedea 5mg/ml solution for injection is a clear, colourless to slightly yellow solution. 
Kako Pedea izgleda i sadržaj pakovanja Pedea 5 mg/ml otopina za injekciju je bistra, bezbojna do blago žuta otopina.
Ibuprofen competes with bilirubin for albumin binding in newborn infant serum and, as a consequence, the free fraction of bilirubin may be increased at high ibuprofen concentrations. 
Ibuprofen se natječe s bilirubinom za vezanje na albumine u serumu novorođenčeta, a kao posljedica, kod visoke koncentracije ibuprofena može doći do porasta slobodnog bilirubina.
Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended. 
Stoga se za dezinfekciju ampule preporučuje 60% -tni etanol ili 70% -tni izopropilni alkohol.
This occurred within one hour of the first infusion and was reversed within 30 minutes after the inhalation of nitric oxide. 
Ova nuspojava se javila unutar jednog sata od prve infuzije i povukla se unutar 30 minuta nakon inhalacije dušikovog oksida.
- your baby may be given corticosteroids to prevent inflammation. 
- Vaše dijete može primati kortikosteroide da bi se spriječila upala.
Pedea is supplied in packs of 4 x 2 ml ampoules. 
Pedea se isporučuje u pakovanju od 4 x 2 ml ampule.
Very common: Thrombocytopenia, Neutropenia 
Vrlo često: Trombocitopenija, Neutropenia
Your baby should therefore be watched for signs of prolonged bleeding. 
NAVOĐENJE DJELATNE(IH) TVARI
Pedea should be administered carefully to avoid extravasation and potential resultant irritation to tissues. 
Pedeu treba pažljivo primijeniti da se izbjegne ekstravazacija i posljedična iritacija okolnog tkiva.
Ibuprofen is a non selective inhibitor of cyclooxygenase, leading to reduced synthesis of prostaglandins. 
Ibuprofen je neselektivni inhibitor ciklooksigenaze, s posljedičnom inhibicijom sinteze prostaglandina.
- The active substance is ibuprofen. 
- Djelatna tvar je ibuprofen.