natgillin/translations-raw huggingface dataset:
The following adverse reactions were identified in patients treated with Maviret. 
Povzetek neželenih učinkov v preglednici Pri bolnikih, zdravljenih z zdravilom Maviret, so ugotovili naslednje neželene učinke.
(P-gp/BCRP inhibition) 
(zavrtje Pgp/BCRP)
ANTICOAGULANTS Dabigatran etexilate 150 mg single dose 
ANTIKOAGULANTI dabigatran-eteksilat enkraten odmerek 150 mg
Glecaprevir and pibrentasvir AUC were similar with and without dialysis (≤ 18% difference) in dialysis-dependent non-HCV infected subjects. 
Pri preiskovancih, odvisnih od dialize in ki niso bili okuženi s HCV, sta bili AUC glekaprevirja in pibrentasvirja z dializo in brez dialize podobni (≤ 18 %
No clinically significant interactions are expected with tenofovir disoproxil fumarate. 
dizoproksiltenofovi ratom ni pričakovati klinično pomembnih medsebojnih delovanj.
In TE-PRS subjects without cirrhosis who received the recommended duration, 98.2% (215/219) achieved SVR12, while 0.5% (1/219) experienced on-treatment virologic failure and 1.4% (3/218) experienced post-treatment relapse. 
Med preiskovanci brez ciroze, ki so bili predhodno zdravljeni s kombinacijo interferona, peginterferona, ribavirina in/ali sofosbuvirja, ki so prejeli zdravljenje v priporočenem trajanju, jih je 98,2 % (215/219) doseglo SVR12; pri 0,5 % (1/219) je med zdravljenjem prišlo do virusne neodzivnosti, pri 1,4 % (3/218) pa se je pojavil recidiv po zdravljenju.
Biliary excretion Biliary excretion t1/2 (h) at steady-state % of dose excreted in urinec % of dose excreted in faecesc 
% odmerka, izločen v urinuc % odmerka, izločen v blatuc
↑ losartan carboxylic acid 
↑ losartan karboksilna kislina valsartan enkraten odmerek 80 mg
Maviret is not recommended for use in patients requiring stable ciclosporin doses > 100 mg per day. 
Zdravila Maviret ni priporočljivo uporabljati pri bolnikih, ki potrebujejo stabilne
Some combinations of NS5A 
Izhodiščne polimorfizme NS5A so odkrili pri
In a pooled analysis of treatment naïve patients without cirrhosis (including Phase 2 and 3 data) where SVR12 was assessed according to the presence of baseline A30K, a numerically lower SVR12 rate was achieved in patients with A30K treated for 8 weeks as compared to those treated for 12 weeks [78% (14/18) vs 93% (13/14)]. 
SVR12 ocenjen glede na prisotnost izhodiščne vrednosti A30K, je bil dosežen delež SVR12 pri bolnikih z A30K, ki so bili zdravljeni 8 tednov, numerično nižji kot pri tistih, ki so bili zdravljeni 12
Co-administration of Maviret with medicinal products that inhibit P-gp and BCRP (e.g. ciclosporin, cobicistat, dronedarone, itraconazole, ketoconazole, ritonavir) may slow elimination of glecaprevir and pibrentasvir and thereby increase plasma exposure of the antivirals. 
Sočasna uporaba zdravila Maviret z zdravili, ki zavirajo P-gp in BCRP (npr. ciklosporin, kobicistat, dronedaron, itrakonazol, ketokonazol, ritonavir),
Maternal toxicity associated with embryo-foetal loss has been observed in the rabbit with glecaprevir which precluded evaluation of glecaprevir at clinical exposures in this species (see section 5.3). 
in to je onemogočilo, da bi pri tej živalski vrsti ocenili glekaprevir v klinični izpostavljenosti (glejte poglavje 5.3).
2D barcode carrying the unique identifier included. 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
Table 7: Clinical studies conducted with Maviret in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 Infection 
Preglednica 7: Klinične študije z zdravilom Maviret pri bolnikih, okuženih s HCV genotipov 1,
Co-administration is contraindicated (see section 4.3). 
Sočasna uporaba je kontraindicirana (glejte poglavje
IMMUNOSUPPRESSANTS Ciclosporin 
IMUNOSUPRESIVI ciklosporin enkraten odmerek 100 mg
↓ glecaprevir ↔ pibrentasvir 
↓ glekaprevir ↓ pibrentasvir
↓ glecaprevir ↓ pibrentasvir 
↓ glekaprevir ↔ pibrentasvir
Co-administration with darunavir is not recommended. 
Sočasna uporaba z darunavirjem ni priporočljiva.
Among GT3b subjects without cirrhosis, a numerically lower SVR12 rate of 58.3% (7/12) [62.5% (5/8) for TN subjects and 50% (2/4) for TE-PRS subjects] was observed compared to GT3a subjects without cirrhosis (92.9% (13/14)). 
(13/14)), opažena numerično nižja stopnja SVR12 58,3 % (7/12) [62,5 % (5/8) pri TN preiskovancih in 50 % (2/4) pri TE-PRS preiskovancih].
No dose adjustment of Maviret is required in adolescents 12 years and older. 
Pri mladostnikih, starih 12 let in več, prilagajanje odmerka zdravila Maviret ni potrebno.
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. 
Povprečna starost pri 101 preiskovancih, ki so bili zdravljeni, je bila 58 let (razpon starosti: 32 do 87); 53 % jih je imelo HCV genotipa 1, 27 % jih je imelo HCV genotipa 2, 15 % jih je imelo HCV genotipa 3, 4 % jih je imelo HCV genotipa 4; 59 % jih je bilo moških; 73 % jih je bilo belcev; 80 % jih še ni bilo zdravljenih; 13 % jih je imelo cirozo in 65 % je imelo osnovno stanje fibroze F0 ali F1; 7
EC50 values of glecaprevir and pibrentasvir against chimeric replicons encoding NS3 or NS5A from clinical isolates are presented in Table 6. 
Vrednosti EC50 za glekaprevir in pibrentasvir proti himernim replikonom za kodiranje NS3 ali NS5A
The use of Maviret in children under 12 years of age has not yet been studied. 
Uporaba zdravila Maviret pri otrocih mlajših od
↔ glecaprevir ↔ pibrentasvir tacrolimus exposure is expected. 
Pričakovana je povečana izpostavljenost takrolimusu.
Treatment-naïve with cirrhosis 
Še nezdravljeni s cirozo
There were no virologic failures. 
Med zdravljenjem ni prišlo do virusne neodzivnosti.
Hepatic impairment 
• utrujenost • glavobol
0.5 mg single dose 
ANTIARITMIKI digoksin enkraten odmerek 0,5 mg
Pravastatin 10 mg once daily 
↑ lovastatinska kislina pravastatin 10 mg enkrat na dan
Lovastatin 10 mg once daily 
↑ simvastatin simvastatinska kislina lovastatin 10 mg enkrat na dan
Co-administration with atorvastatin and simvastatin is contraindicated (see section 4.3). 
Sočasna uporaba z atorvastatinom in simvastatinom je kontraindicirana (glejte poglavje simvastatin 5 mg enkrat na dan
Propylene glycol monocaprylate (Type II) Croscarmellose sodium 
Jedro tablete kopovidon (tip K 28) polietilenglikolsukcinat vitamina E (tokoferola) koloidni brezvodni silicijev dioksid propilenglikol monokaprilat (tip II) premreženi natrijev karmelozat natrijev stearilfumarat
However, in some cases this does not happen. 
Vendar pa se to v nekaterih primerih ne zgodi.
4 years. 
4 leta.
* see below 
*glejte spodaj
All patients recovered with conventional treatment. 
Vsi bolniki so si po konvencionalnem zdravljenju opomogli.
Date of first authorisation: 29 July 2004 Date of renewal: 29 July 2009 
Datum pridobitve dovoljenja za promet: 29. julij 2004 Datum zadnjega podaljšanja: 29. julij 2009
These are detailed below: 
Ti so natančneje opisani spodaj:
This can cause heart problems in your baby. 
To lahko pri vašem otroku povzroči težave s srcem.
It may harm them, even if their symptoms are the same as your baby's. 
Njim bi lahko celo škodovalo, čeprav imajo enake simptome kot vaš otrok.
• Risk Management Plan (RMP) Not applicable. 
• Načrt za obvladovanje tveganja (RMP)
The first injection should be given after the first 6 hours of life. 
Prvo injekcijo moramo dati po prvih 6 urah življenja.
The apparent volume of distribution is on average 200 ml/kg (62 to 350 according to various studies). 
Povprečen volumen porazdelitve je 200 ml/kg (62 do 350 po različnih študijah).
Please tell your doctor or pharmacist if your baby is taking or has recently taken any other medicines, including medicines obtained without a prescription. 
Obvestite svojega zdravnika ali farmacevta, če vaš otrok prejema ali je pred kratkim prejel katerokoli zdravilo, tudi če ste ga dobili brez recepta.
If you have further questions, please ask your doctor or your pharmacist. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
With the exception of an acute toxicity study, no further studies have been carried out in juvenile animals with Pedea. 
Z izjemo študije akutne toksičnosti, nadaljnje študije z zdravilom Pedea na mladičih živali niso bile izvedene.
The central volume of distribution may depend on the status of the ductus and decrease as the ductus closes. 
Centralni volumen porazdelitve je lahko odvisen od statusa duktusa in se ob zapiranju duktusa zmanjša.
- Pedea should not be given in the first 6 hours of life. 
- Zdravilo Pedea se ne sme dajati v prvih 6 urah življenja.
Frequencies are defined as: very common (≥ 1/10), common (≥1/100, <1/10) and uncommon (≥1/1,000, <1/100). 
Pogostnost je definirana kot: zelo pogosto (≥1/10), pogosto (≥1/100,<1/10) in občasno (≥1/1000,<1/100).
Posology and method of administration (see also section 3) 
Odmerjanje in način uporabe (glejte tudi poglavje 3)
Careful monitoring of both renal and gastrointestinal function is recommended. 
Priporočljivo je nadzorovati ledvično in gastrointestinalno funkcijo.
Pharmacotherapeutic group: other cardiac preparations, ATC code: C01 EB16 
Farmakoterapevtska skupina: druga zdravila za bolezni srca, oznaka ATC: C01EB16
In vivo and in vitro studies indicate that the S(+) isomer is responsible for the clinical activity. 
In vivo in in vitro študije kažejo, da je za klinično učinkovitost odgovorna S(+) izomera.
While a baby is inside its mother's womb it does not need to use its lungs. 
V času, ko je otrok v maternici, ne uporablja svojih pljuč.
However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease. 
Te pa je težko razlikovati od zapletov, ki se pogosto pojavljajo pri nedonošenčkih, in zapletov, ki so posledica bolezni.
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%). 
Plazemske koncentracije S-enantiomer so mnogo višje od koncentracij R-enantiomer, kar kaže na hitro kiralno inverzijo R- v S- obliko, v podobnem razmerju kot pri odraslih (okrog 60 %).
For intravenous use only. 
Samo za intravensko uporabo.
Reported adverse reactions are listed below, by system organ class and by frequency. 
Neželeni učinki, o katerih so poročali, so navedeni spodaj po organskih sistemih in pogostnosti.
This condition is much more frequent in premature newborn than in full-term newborn infants. 
To stanje je veliko pogostejše pri nedonošenčkih kot pri donošenih dojenčkih.
WHAT PEDEA IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO PEDEA IN ZA KAJ GA UPORABLJAMO
- If your baby is suspected of having liver disease, signs and symptoms of which include yellowing of the skin and eyes. 
- V primeru, da ima vaš otrok jetrno bolezen ali znake in simptome, ki vključujejo rumeno kožo ali oči.
Using other medicines 
Uporaba drugih zdravil:
- If your baby is already suffering from an infection that is being treated, the doctor will treat your baby with Pedea only after careful consideration of your baby's condition. 
- Če ima vaš otrok okužbo, ki jo že zdravijo, bo zdravnik uporabil zdravilo Pedea le po temeljitem premisleku o stanju vašega otroka.
EXP From a microbiological point of view, the product should be used immediately 
Uporabno do Z mikrobiološkega stališča je treba zdravilo porabiti takoj.
Ibuprofen is a racemic mixture of S(+) and R(-) enantiomers. 
Ibuprofen je racemat S(+) in R(-) enantiomer.
Pedea solution must not be in contact with any acidic solution such as certain antibiotics or diuretics. 
Zdravilo Pedea ne sme priti v stik s kakršnokoli kislo raztopino, kot na primer nekateri antibiotiki ali diuretiki.
Elimination rate is markedly lower than in older children and adults, with an elimination half-life estimated at approximately 30 hours (16-43). 
Hitrost izločanja zdravila iz telesa je znatno manjša kot pri starejših otrocih in odraslih, razpolovni čas odstranjevanja iz telesa ocenjujejo na približno 30 ur (16-43).
The clearance of both enantiomers increases with gestational age, at least in the range of 24 to 28 weeks. 
Očistek obeh enantiomer se zvečuje z gestacijsko starostjo, vsaj v mejah od 24 do 28 tednov.
Since prostaglandins are involved in the persistence of the ductus arteriosus after birth, this effect is believed to be the main mechanism of action of ibuprofen in this indication. 
Ker so prostaglandini odgovorni za vztrajanje odprtega duktusa arteriozusa po rojstvu, je ta učinek zdravila glavni mehanizem delovanja ibuprofena pri tej indikaciji.
- Pedea may reduce the amount of urine your baby passes. 
- Zdravilo Pedea lahko zmanjša količino urina, ki ga vaš otrok izloči.
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. 
Če se po prvem ali drugem odmerku pojavi anurija ali manifestna oligurija, ne smemo dati naslednjega odmerka, dokler se izločanje urina ne vrne na normalne vrednosti.
- your baby may be given nitric oxide to improve blood oxygenation. 
- vaš otrok lahko za izboljšanje oksigenacije krvi prejema dušikov oksid.
Not known: - Perforation of the stomach 
Neznana: - predrtje (perforacija) želodca
Detailed information on this product is available on the web site of the European medicines Agency (EMEA) http://www.emea.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
- your baby may have problems passing urine and may have been prescribed diuretics. 
- vaš otrok ima lahko oteženo izločanje urina in ima predpisane diuretike.
When the baby is born and starts using its lungs the ductus arteriosus normally closes. 
Po rojstvu otrok prične uporabljati pljuča in se ductus arteriosus ponavadi zapre.
Pedea, when given to your baby, can help to close the ductus arteriosus. 
Zdravilo Pedea, dano vašemu otroku, lahko pomaga pri zapiranju arterioznega duktusa.
Ibuprofen is a non selective inhibitor of cyclooxygenase, leading to reduced synthesis of prostaglandins. 
Ibuprofen je neselektivni inhibitor ciklooksigenaze, kar zmanjšuje sintezo prostaglandinov.
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) 
Pogostnost spodaj navedenih neželenih učinkov je opredeljena z naslednjim dogovorom: zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov); pogosti (pojavijo se pri 1 do 10 bolnikov od 100 bolnikov); občasni (pojavijo se pri 1 do 10 bolnikov od 1.000 bolnikov); zelo redki (pojavijo se pri manj kot 1 od 10.000 bolnikov); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Massive overdose (up to more than 1000 mg/kg) has been reported to induce coma, metabolic acidosis, and transient renal failure. 
Izrazito preveliki odmerki (do več kot 1000 mg/kg) povzročajo komo, presnovno acidozo in prehodno odpoved ledvic.
This occurred within one hour of the first infusion and was reversed within 30 minutes after the inhalation of nitric oxide. 
To se je zgodilo eno uro po prvi infuziji zdravila in se je izboljšalo v 30 minutah po inhalacijah dušikovega oksida.
Certain medicines, if given together with Pedea, may cause side effects. 
Nekatera zdravila lahko v kombinaciji z zdravilom Pedea povzročijo neželene učinke.
To facilitate the administration an infusion pump may be used. 
Dajanje se lahko olajša z uporabo infuzijske črpalke.
The concomitant use of Pedea with the following medicinal products is not recommended: - diuretics: ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients. 
Sočasna uporaba zdravila Pedea ni priporočljiva z naslednjimi zdravili: - diuretiki: ibuprofen lahko zmanjša učinek diuretikov; diuretiki lahko povečajo nevarnost nefrotoksičnosti nesteroidnih protivnetnih in protirevmatičnih zdravil pri dehidriranih bolnikih.
Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended. 
Zato se za asepso ampule pred uporabo priporoča 60 % etanol ali 70 % izopropilalkohol
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. 
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Take special care with Pedea - Before treatment with Pedea, your baby's heart will be examined to confirm that the ductus arteriosus is open. 
Bodite posebno pozorni pri uporabi zdravila Pedea: - Pred zdravljenjem z zdravilom Pedea bodo vašemu otroku pregledali srce in potrdili odprti ductus arteriosus.
PK-PD relationship 
Zveza med PK in PD
Ampoules are intended for single use only, any unused portions must be discarded. 
Ampule so namenjene le za enkratno uporabo, vse neporabljeno zdravilo je potrebno zavreči.
Like all medicines, Pedea can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo Pedea neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your baby's doctor or your pharmacist. 
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite otrokovega zdravnika ali svojega farmacevta.
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. 
Upoštevati je potrebno maksimalni volumen 80 ml/kg/dan prvi dan življenja, ki ga postopoma zvišujete v naslednjih 1-2 tednih (okrog 20 ml/kg porodne teže/dan) do maksimalnega volumna 180 ml/kg porodne mase/dan.
- your baby may be given corticosteroids to prevent inflammation. 
- vaš otrok lahko prejema kortikosteroide za preprečevanje vnetij.
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. 
Opisan je le en primer smrti: pri 16 mesečnem otroku se je po prevelikem odmerku 469 mg/kg razvila apneja s krči in usodna aspiracijska pljučnica.
- nitric oxide: since both medicinal products inhibit platelet function, their combination may in theory increase the risk of bleeding. 
- dušikov oksid: ker obe zdravili zavirata trombocitno fukcijo, lahko teoretično kombinacija zdravil poveča nevarnost krvavitve.
To detect this, your baby's stools and urine may be tested to determine if there is any blood present in them. 
Da to ugotovimo, je potrebno kontrolirati blato in urin vašega otroka na prisotnost krvi.
Before administration of Pedea an adequate echocardiographic examination should be performed in order to detect a haemodynamically significant patent ductus arteriosus and to exclude pulmonary hypertension and ductal-dependent congenital heart disease. 
Pred zdravljenjem z zdravilom Pedea je potrebno opraviti ustrezno ehokardiografsko preiskavo za določitev hemodinamično pomembnega odprtega duktusa arteriozusa in izključitev pljučne hipertenzije ali od duktusa odvisnih prirojenih srčnih napak.
2 ml solution in a colourless type 1 glass ampoule. 
2 ml raztopine v brezbarvni ampuli iz stekla tipa 1.
Solution for injection 4 x 2 ml ampoules 
raztopina za injiciranje 4 x 2 ml ampule
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. 
Čeprav obstaja v populaciji nedonošenčkov velika variabilnost, so izmerjene najvišje koncentracije med 35 in 40 mg/l po začetnem odmerku 10 mg/kg, kakor tudi po vzdrževalnem odmerku, ne glede na gestacijsko ali postnatalno starost.
- aminoglycosides: since ibuprofen may decrease the clearance of aminoglycosides, their coadministration may increase the risk of nephrotoxicity and ototoxicity (see section 4.4). 
- aminoglikozidi: ker ibuprofen lahko zmanjša očistek aminoglikozidov, lahko njihovo sočasno dajanje zveča tveganje nefrotoksičnosti in ototoksičnosti (glejte poglavje 4.4).
- Pedea may be less effective in very premature babies less than 27 weeks of gestational age. 
- Zdravilo Pedea je lahko pri mlajših nedonošenčkih z gestacijsko starostjo manj kot 27 tednov manj učinkovito.
This calculated amount will be given by infusion in a vein over a period of 15 minutes. 
Izračunan odmerek bo prejel v obliki intravenske infuzije v 15 minutah.
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 %). 
In vitro študije kažejo, da je, podobno kot ostale nesteroidne protivnetne in protirevmatične zdravilne učinkovine, ibuprofen v visokem odstotku vezan na plazemske albumine, vendar pomembno nižjem (95 %) v primerjavi z odraslimi (99 %).
Excipients: each ml contains 7.5 mg of sodium. 
Pomožne snovi: en ml vsebuje 7,5 mg natrija.
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. 
Nerojen otrok ima blizu srca žilo, imenovano arteriozni duktus (ductus arteriosus), ki omogoča, da kri zaobide pljuča in kroži po ostalem delu telesa.
Treatment with Pedea can only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist. 
Zdravljenje z zdravilom Pedea se lahko izvaja le v neonatalnih intenzivnih enotah pod nadzorom izkušenega neonatologa.
If hypoxaemia occurs during or following Pedea infusion, close attention should be paid to pulmonary pressure. 
Če se med infundiranjem zdravila Pedea ali po njem pojavi hipoksemija, je treba skrbno nadzirati pljučni tlak.
Therefore, ibuprofen should not be used in infants with marked elevated bilirubin concentration. 
Zato ibuprofena ne smete uporabljati pri novorojenčkih z znatno zvišano koncentracijo bilirubina.
Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the Pedea solution. 
Za razkuževanje vrata ampule se ne sme uporabljati kloroheksidina, ker ni združljiv z raztopino zdravila Pedea.
In a clinical curative trial involving 175 preterm newborn infants less than 35 weeks of gestational age, the incidence of bronchopulmonary dysplasia at 36 weeks post-conceptional age was 13/81 (16%) for indomethacin versus 23/94 (24%) for ibuprofen. 
V kurativnem kliničnem preskušanju, v katerega je bilo vključeno 175 nedonošenčkov, z gestacijsko starostjo manj kot 35 tednov, je bila pogostnost bronhopulmonalne displazije, pri starosti 36 tednov po spočetju, 13/81 (16 %) za indometacin proti 23/94 (24 %) za ibuprofen.
The medical term for this condition is ‘patent ductus arteriosus', i.e. an open ductus arteriosus. 
Medicinski izraz za to stanje je prehoden ali odprt ductus arteriosus.
Important information about some of the ingredients of Pedea This medicinal product contains less than 1 mmol sodium (15 mg) per 2 ml, i.e. essentially ‘sodiumfree'. 
Pomembne informacije o nekaterih sestavinah zdravila Pedea To zdravilo vsebuje manj kot 1 mmol natrija (15 mg) na 2 ml, kar v bistvu pomeni 'brez natrija'.
Ibuprofen may reduce the effect of these medicines. 
Ibuprofen lahko zmanjša učinkovitost teh zdravil.
Method of administration: 
Način uporabe: