natgillin/translations-raw huggingface dataset:
A 16-week treatment duration should be considered in genotype 3-infected patients who are treatment experienced with peg-IFN + ribavirin +/sofosbuvir, or sofosbuvir + ribavirin.
U bolesnika zaraženih genotipom 3 koji su prethodno liječeni kombinacijom peginterferon + ribavirin +/- sofosbuvir ili sofosbuvir + ribavirin treba razmotriti liječenje u trajanju od 16 tjedana.
Ciclosporin 400 mg single dose
Ciklosporin jednokratna doza od 400 mg
Pravastatin 10 mg once daily
Pravastatin 10 mg jedanput na dan
The ability to assess the impact of baseline polymorphisms in NS5A was limited among treatment-naïve subjects with cirrhosis and treatment-experienced subjects due to low prevalence of A30K (1.6%, 2/128) or Y93H (3.9%,
U prethodno neliječenih ispitanika s cirozom te prethodno liječenih ispitanika mogućnost ocjene utjecaja polimorfizama NS5A na početku ispitivanja bila je ograničena zbog niske prevalencije A30K (1,6%,
All of the genotype 1-infected virologic failure subjects had one or more NS5A substitutions L/M28M/T/V, Q30E/G/H/K/L/R, L31M, P32 deletion, H58C/D, or Y93H at baseline, with additional treatment-emergent NS5A substitutions M28A/G, P29Q/R, Q30K, H58D, or Y93H observed in 7 of the subjects at the time of failure.
U svih ispitanika s infekcijom genotipom 1 koji su doživjeli virološki neuspjeh je na početku ispitivanja bila prisutna jedna ili više supstitucija u proteinu NS5A: L/M28M/T/V, Q30E/G/H/K/L/R, L31M, delecija P32, H58C/D ili
↑ lovastatin acid
↑ lovastatinska kiselina
d. GT3 with cirrhosis from SURVEYOR-2 Part 2 - Maviret for 12 weeks (n=24) or 16 weeks (n=4); GT3 with cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=40) or 16 weeks (n=47).
d. Ispitanici s genotipom 3 i cirozom iz 2. dijela ispitivanja SURVEYOR-2 - Maviret tijekom 12 tjedana (n=24) ili 16 tjedana (n=4); ispitanici s genotipom 3 i cirozom iz 3. dijela ispitivanja SURVEYOR-2 - Maviret tijekom 12 tjedana (n=40) ili 16 tjedana (n=47).
(Inhibition of OATP1B1/3, P-gp, BCRP)
(inhibicija OATP1B1/3, P-gp-a, BCRP-a)
Medicinal products that are strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarbital, phenytoin, and primidone) could significantly decrease glecaprevir or pibrentasvir plasma concentrations and may lead to reduced therapeutic effect of Maviret or loss of virologic response.
(Hypericum perforatum), fenobarbital, fenitoin i primidon) mogli bi značajno sniziti plazmatske koncentracije glekaprevira ili pibrentasvira te dovesti do smanjenja terapijskog učinka lijeka Maviret ili gubitka virološkog odgovora.
Liver or kidney transplant patients
Bolesnici s jetrenim ili bubrežnim presatkom
Glecaprevir is affected to a lower extent by coadministration with pibrentasvir.
Istodobna primjena s pibrentasvirom u manjoj mjeri utječe na glekaprevir.
(Inhibition of OATP1B1/3, BCRP)
(inhibicija OATP1B1/3, BCRP-a)
SURVEYOR-2 Part 3 was an open-label study randomizing non-cirrhotic treatment-experienced subjects to 12- or 16-weeks of treatment; in addition, the study evaluated the efficacy of Maviret in subjects with compensated cirrhosis and genotype 3 infection in two dedicated treatment arms using 12-week (treatment-naïve only) and 16-week (treatmentexperienced only) durations.
u ispitivanju se ocjenjivala djelotvornost lijeka Maviret u ispitanika s kompenziranom cirozom i infekcijom genotipom 3, podijeljenih u dvije skupine, od kojih je jedna liječena 12 tjedana (samo prethodno neliječeni ispitanici), a druga 16 tjedana (samo prethodno liječeni bolesnici).
Five of the 10 had combinations of V36M, Y56H, R155K/T, or D168A/E in NS3 at baseline and post-treatment.
U 5 od tih 10 ispitanika su na početku ispitivanja i nakon liječenja bile prisutne kombinacije supstitucija V36M, Y56H, R155K/T ili D168A/E u proteinu NS3.
In subjects who are treatment-naïve (TN) or treatment-experienced to combinations of interferon, peginterferon, ribavirin and/or sofosbuvir (TE-PRS) who received the recommended duration, 97.5% (1,252/1,284) achieved SVR12 overall, while 0.3% (4/1,284) experienced on-treatment virologic failure and 0.9% (11/1,262) experienced post-treatment relapse.
Među ispitanicima koji prethodno nisu bili liječeni ili su prethodno liječeni kombinacijama interferona, peginterferona, ribavirina i/ili sofosbuvira (PRS), a koji su primali lijek tijekom preporučenog razdoblja, sveukupno je njih 97,5% (1252/1284) postiglo SVR12, dok je njih 0,3%
Posology
Prijenos
Asymptomatic serum ALT elevations (>5x ULN) were observed in 1 out of 70 healthy subjects following multiple doses of glecaprevir (700 mg or 800 mg) once daily for ≥ 7 days.
Nakon primjene višestrukih doza glekaprevira (700 mg ili 800 mg) jedanput na dan tijekom ≥ 7 dana, u 1 od
Talk to your doctor before taking Maviret if you are breast-feeding.
razgovarajte sa svojim liječnikom ili ljekarnikom prije nego uzmete Maviret.
Package leaflet: Information for the user Maviret 100 mg/40 mg film-coated tablets glecaprevir/pibrentasvir This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za korisnika Maviret 100 mg/40 mg filmom obložene tablete glekaprevir/pibrentasvir
Outcome for subjects without SVR12 On-treatment VF
Ishod u ispitanika bez SVR12 Virološki neuspjeh tijekom liječenja
Patients treated with vitamin K antagonists
Kod primjene svih antagonista vitamina
↑ digoxin
↑ digoksin
Substrate of transporter
Supstrat prijenosnika
Treatment difference -1.2%; 95% confidence interval (-5.6% to 3.1%) Treatment difference -0.4%; 97.5% confidence interval (-5.4% to 4.6%) Outcome for subjects without SVR12 On-treatment VF Relapsea Otherb a. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
interval pouzdanosti 97,5% (-5,4% do 4,6%) Ishod u ispitanika bez SVR12 Virološki neuspjeh tijekom liječenja
Studies in treatment-naïve and peginterferon (pegIFN), ribavirin (RBV) and/or sofosbuvir treatmentexperienced subjects with or without cirrhosis
Ispitivanja u ispitanika s cirozom ili bez nje koji prethodno nisu bili liječeni i onih koji su prethodno liječeni peginterferonom (pegIFN), ribavirinom (RBV) i/ili sofosbuvirom
The most common adverse reactions in subjects with severe renal impairment were pruritus (17%) and fatigue (12%) in EXPEDITION-4 and pruritus (14.9%) in EXPEDITION-5.
(12%) u ispitivanju EXPEDITION-4 te pruritus (14,9%) u ispitivanju EXPEDITION-5.
TN and PRS-TE subjects with cirrhosis GT1, 2, 4, 5, 6 EXPEDITION-1 Maviret for 12 weeks (n=146) GT3
Ispitanici s cirozom koji su prethodno neliječeni i koji su prethodno liječeni peginterferonom (ili interferonom) i/ili ribavirinom i/ili sofosbuvirom GT1, 2, 4, 5, 6 EXPEDITION-1 Maviret tijekom 12 tjedana (n=146) GT3
The pharmacokinetic properties of the components of Maviret are provided in Table 11.
iz kliničkih izolata prikazane su u Tablici 6.
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.