natgillin/translations-raw huggingface dataset:
- nitric oxide: since both medicinal products inhibit platelet function, their combination may in
- dušikov oksid: ker obe zdravili zavirata trombocitno fukcijo, lahko teoretično kombinacija zdravil
theory increase the risk of bleeding.
poveča nevarnost krvavitve.
- other NSAIDs: the concomitant use of more than one NSAID should be avoided because of the
- ostala nesteroidna protivnetna in protirevmatična zdravila: sočasno jemanje večih nesteroidnih
increased risk of adverse reactions.
protivnetnih in protirevmatičnih zdravil ni proporočljivo zaradi povečane nevarnosti neželenih učinkov.
- aminoglycosides: since ibuprofen may decrease the clearance of aminoglycosides, their co-
- aminoglikozidi: ker ibuprofen lahko zmanjša očistek aminoglikozidov, lahko njihovo sočasno
administration may increase the risk of nephrotoxicity and ototoxicity (see section 4.4).
dajanje zveča tveganje nefrotoksičnosti in ototoksičnosti (glejte poglavje 4. 4).
3 4.6 Pregnancy and lactation
3 Navedba smiselno ni potrebna.
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.
Trenutno so na voljo podatki o 1000 nedonošenčkih, tako iz literature o ibuprofenu kot iz kliničnih preskušanj s Pedeo. Vzročno povezanost poročanih neželenih učinkov je zaradi povezanosti le teh, tako s hemodinamičnimi posledicami odprtega duktusa arteriozusa kot direktnimi učinki ibuprofena, težko ocenjevati.
Reported adverse events are listed below, by system organ class and by frequency.
Neželeni učinki, o katerih so poročali, so navedeni spodaj po organskih sistemih in pogostnosti.
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).
Blood and lymphatic system disorders Nervous system disorders
Bolezni krvi in limfatičnega sistema Bolezni živčevja
Intraventricular haemorrhage, Periventricular leukomalacia
Zelo pogosto: trombocitopenija, nevtropenija Pogosto: intraventrikularne krvavitve, periventrikularna levkomalacija
Hypoxemia
Zelo pogosto: bronhopulmonalna displazija Pogosto: krvavitve v pljučih Občasno: hipoksemija
Gastrointestinal haemorrhage
Pogosto: nekrotizirajoči enterokolitis, perforacija prebavil Občasno: krvavitve iz prebavil
Acute renal failure
Pogosto: oligurija, retenca tekočin, hematurija Občasno: akutna odpoved ledvic
Blood creatinine increased, Blood sodium decreased
Zelo pogosto: povišan kreatinin v krvi, znižan natrij v krvi
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.
In a clinical trial where Pedea was administered prophylactically during the first 6 hours of life, severe hypoxemia with pulmonary hypertension was reported in 3 newborn infants less than 28 weeks of gestational age.
V kliničnem preskušanju, v katerem so nedonošenčki profilaktično prejemali Pedeo v prvih 6 urah življenja, se je pri 3 novorojenčkih, z gestacijsko starostjo manj kot 28 tednov, pojavila huda hipoksemija s pljučno hipertenzijo.
CNS depression, seizures, gastrointestinal disturbances, bradycardia, hypotension, apnoea, abnormal renal function, haematuria have been observed.
Opisani pa so primeri prevelikega odmerjanja pri dojenčkih in otrocih, zdravljenih s peroralno obliko ibuprofena: depresija CŽS, krči, gastrointestinalne motnje, bradikardija, hipotenzija, apnoa, motnje ledvične funkcije, hematurija.
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, metabolno acidozo in prehodno odpoved ledvic.
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.
C01 EB16
C01EB16
Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity.
Ibuprofen je nesteroidno protivnetno in protirevmatično zdravilo, ki deluje protivnetno, analgetično in antipiretično.
Ibuprofen is a racemic mixture of S(+) and R(-) enantiomers.
Ibuprofen je racemat S( +) in R (-) enantiomer.
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.
In a dose-response study of Pedea in 40 preterm newborn infants, the ductus arteriosus closure rate associated to the 10-5-5 mg/ kg dose regimen was 75% (6/ 8) in neonates of 27-29 weeks’ gestation and 33% (2/ 6) in neonates of 24-26 weeks ’ gestation.
V študiji odgovora na odmerek Pedee pri 40 nedonošenčkih, se je ductus arteriosus, pri shemi odmerjanja 10- 5- 5 mg/ kg, zaprl pri 75% (6/ 8) novorojenčkih z gestacijsko starostjo 27- 29 tednov in pri 33% (2/ 6) novorojenčkih z gestacijsko starostjo 24- 26 tednov.
Prophylactic use of Pedea in the first 3 days of life (starting within 6 hours of birth) in preterm newborn infants less than 28 weeks of gestational age was associated with increased incidence of renal failure and pulmonary adverse events including hypoxia, pulmonary hypertension, pulmonary haemorrhage, as compared to curative use.
Profilaktična uporaba Pedee v prvih 3 dneh življenja (začeta v prvih 6 urah po rojstvu) pri nedonošenčkih, z gestacijsko starostjo manj kot 28 tednov, je bila, za razliko od kurativne uporabe, povezana s povečano pogostnostjo ledvične odpovedi ter neželenih učinkov na dihalih vključujoč hipoksijo, pljučno hipertenzijo, krvavitve iz dihal.
Conversely, a lower incidence of neonatal grade III-IV intraventricular haemorrhage and of surgical ligation was associated with prophylactic use of Pedea.
Nasprotno pa je bila ob profilaktični uporabi Pedee manjša pogostnost neonatalne intraventrikularne krvavitve stopnje III- IV in manjša potreba po kirurški ligaciji odprtega duktusa arteriozusa.
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.
Residual concentrations are around 10- 15 mg/ l 24 hours after the last dose of 5 mg/ kg.
24 ur po zadnjem odmerku 5 mg/ kg je končna koncentracija 10- 15 mg/ l.
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%).
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).
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 je izrazito nižja kot pri starejših otrocih in odraslih, z razpolovnim časom izločanja 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 z višanjem gestacijske starosti povečuje, vsaj v območju 24 do 28 tednov.
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 ostala nesteroidna protivnetna in protirevmatična zdravila, ibuprofen v visokem odstotku vezan na plazemske albumine, vendar pomembno nižjem (95%) v primerjavi z odraslimi (99%).
In preterm newborns ibuprofen significantly reduced plasma concentrations of prostaglandins and their metabolites, particularly PGE2 and 6-keto-PGF-1-alpha.
Ibuprofen pri nedonošenčkih pomembno zniža plazemsko koncentracijo prostaglandinov in njihovih metabolitov, predvsem PGE2 in 6- keto- PGF- 1- alfa.
Low levels were sustained up to 72 hours in neonates who received 3 doses of ibuprofen, whereas subsequent re-increases were observed at 72 hours after only 1 dose of ibuprofen.
Nižje koncentracije so vztrajale do 72 ur pri novorojenčkih, ki so prejeli 3 odmerke ibuprofena, medtem ko se je le po 1 odmerku ibuprofena koncentracija ponovno zvišala po 72 urah.
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 s Pedeo na mladičih živali niso bile izvedene.
Trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.
Trometamol, natrijev klorid, natrijev hidroksid (za prilagoditev pH), klorovodikova kislina 25 -% (za prilagoditev pH) voda za injekcije.
Pedea solution must not be in contact with any acidic solution such as certain antibiotics or diuretics.
Pedea ne sme priti v stik s kakršnokoli kislo raztopino, kot na primer nekateri antibiotiki ali diuretiki.
A rinse of the infusion line must be performed between each product administration (see section 6.6).
Med aplikacijami posameznih zdravil je potrebno infuzijske sisteme sprati (glej poglavje 6. 6).
Colourless type 1 glass ampoule.
Brezbarvna ampula iz stekla tipa 1.
Pedea is supplied in packs of 4 x 2 ml ampoules.
Pedea je na voljo v škatlah s 4 ampulami po 2 ml.
As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use.
Kot vse parenteralne pripravke je potrebno ampule Pedee pred uporabo pregledati glede prisotnosti delcev in integritete embalaže.
Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the Pedea solution.
Kloroheksidin se ne sme uporabljati za razkuževanje vrata ampule, ker ni združljiv s Pedea raztopino.
Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended.
Zato se, pred uporabo, za asepso ampule priporoča etanol 60% ali izopropil alkohol 70%.
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 izognili kakeršnikoli reakciji s Pedea raztopino, pri razkuževanju vrata ampule z antiseptikom, je treba zagotoviti, da je ampula popolnoma suha, preden jo odpremo.
The required volume to be given to the infant should be determined according to body weight, and should be injected intravenously as a short infusion over 15 minutes, preferably undiluted.
Potreben volumen, ki naj bi ga prejel novorojenček, mora biti prilagojen na telesno maso in injiciran intravensko v kratki 15- minutni infuziji, najbolje nerazredčen.
Use only sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution to adjust injection volume.
Za prilagajanje volumna uporabljajte le 0, 9 -% raztopino natrijevega klorida 9 mg/ ml ali 5 -% raztopino glukoze (50 mg/ ml).
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 teže/ dan.
Before and after administration of Pedea, to avoid contact with any acidic solution, rinse the infusion line over 15 minutes with 1.5 to 2 ml of either sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%), solution for injection.
Pred vsako aplikacijo Pedee, v izogib stika s kislimi raztopinami, spirajte infuzijski sistem 15 minut z 1, 5 do 2 ml 0, 9 -% raztopine natrijevega klorida (9 mg/ ml) ali 5% raztopine glukoze za injiciranje (50 mg/ ml).
6 After first opening of an ampoule, any unused portions must be discarded.
6 Z mikrobiološkega stališča je potrebno zdravilo uporabiti takoj.
Orphan Europe SARL Immeuble “ Le Wilson” F-92058 Paris La Défense - France
Orphan Europe SARL Immeuble “ Le Wilson ” F- 92058 Paris La Défense - Francija
29 July 2004
29. julija 2004
8 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Orphan Europe S. A. R. L., Immeuble “ Le Wilson” 70 avenue du Général de Gaulle F- 92800 Puteaux, France
Orphan Europe SARL, Immeuble “ Le Wilson ” 70 avenue du Général de Gaulle F - 92800 Puteaux Francija
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Pedea 5 mg/ ml solution for injection Ibuprofen
Pedea 5 mg/ ml raztopina za injiciranje ibuprofen
Each ml contains 5 mg ibuprofen Each 2 ml ampoule contains 10 mg ibuprofen
Ena 2- ml ampula vsebuje 10 mg ibuprofena.
Excipients: trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.
Pomožne snovi: trometamol, natrijev klorid, natrijev hidroksid (za prilagoditev pH), 25 -% klorovodikova kislina (za prilagoditev pH), voda za injekcije.
4 x 2 ml ampoules
4 x 2- ml ampule
Intravenous use as short infusion Read the package leaflet before use From a microbiological point of view, the product should be used immediately
Z mikrobiološkega stališča je potrebno zdravilo porabiti takoj.
Orphan Europe SARL Immeuble “ Le Wilson” F-92058 Paris La Défense- France
Orphan Europe SARL Immeuble “ Le Wilson ” F- 92058 Paris La Défense - Francija
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 ODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
GLASS AMPOULE TEXT (white label stuck on the ampoule)
TEKST NA STEKLENI AMPULI (bela etiketa na ampuli)
Pedea 5 mg/ ml solution for injection Ibuprofen IV use
Pedea 5 mg/ ml injekcija ibuprofen i. v.
See leaflet
Glej priložena
COMPANY NAME
IME PODJETJA
15 PACKAGE LEAFLET
15 NAVODILO ZA UPORABO
Read all of this leaflet carefully before this medicine is administered to your baby.
Preberite navodila preden vaš dojenček dobi zdravilo!
- This medicine has been prescribed for your baby and should not be passed on to others.
- Zdravilo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
It may
Njim bi lahko celo
harm them, even if their symptoms are the same as your baby ’ s.
škodovalo, čeprav imajo znake bolezni, podobne tistim vašega otroka.
What Pedea is and what it is used for 2.
Kaj je Pedea in za kaj jo uporabljamo 2.
Before Pedea is administered to your baby 3.
Kaj morate vedeti, preden bo vaš otrok dobil Pedeo 3.
How Pedea is used 4.
Kako uporabljati Pedeo 4.
Storing Pedea 6.
Shranjevanje Pedee 6.
Each 2 ml ampoule
En ml vsebuje 5 mg ibuprofena. Ena 2- ml ampula vsebuje
contains 10 mg ibuprofen.
10 mg ibuprofena.
- The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment),
- Pomožne snovi so trometamol, natrijev klorid, natrijev hidroksid (za prilagoditev pH), 25 -%
hydrochloric acid 25% (for pH adjustment) and water for injections.
klorovodikova kislina (za prilagoditev pH) ter voda za injekcije.
Marketing authorisation holder and Manufacturer:
Imetnik dovoljenja za promet z zdravilom in izdelovalec:
WHAT PEDEA IS AND WHAT IT IS USED FOR
KAJ JE PEDEA IN ZA KAJ JO UPORABLJAMO
Pedea is a solution for injection available in cartons of four 2 ml ampoules.
Pedea je raztopina za injiciranje, na voljo v škatlah s štirimi ampulami po 2 ml.
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.
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.
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.
This can cause heart problems in your baby.
To lahko pri vašem otroku povzroči srčne težave.
This condition is much more frequent in premature newborn than in full-term newborn infants.
To stanje je veliko pogostejše pri nedonošenčkih.
Pedea, when given to your baby, can help to close the ductus arteriosus.
Pedea, dana vašemu otroku, lahko pomaga pri zapiranju arterioznega duktusa.
Pedea closes the ductus arteriosus by inhibiting the production of prostaglandin, a naturally occurring chemical in the body which keeps the ductus arteriosus open.
Pedea zapre ductus arteriosus z zaviranjem sinteze prostaglandinov, v telesu vašega otroka normalno prisotnih kemičnih snovi, ki vzdržujejo ductus arteriosus odprt.
BEFORE PEDEA IS ADMINISTERED TO YOUR BABY
KAJ MORATE VEDETI, PREDEN BO VAŠ OTROK PREJEL PEDEO
Pedea must not be given to babies:
Pedee ne smejo prejemati otroci:
- if they have a life-threatening infection which has not been treated;
- če imajo življenje ogrožujoče infekcije, ki niso bile zdravljene;
- if they are bleeding, especially if the bleeding is inside the skull or in the intestines;
- če krvavijo, še posebno če krvavijo v lobanjo ali črevo;
- if they have problems with their blood clotting;
- če imajo težave s strjevanjem krvi;
- if they have kidney problems.
- če imajo težave z ledvicami;
- if they have other problems with their heart which require the ductus arteriosus to remain open
- če imajo druge srčne napake, ki zahtevajo odprt ductus arteriosus za zadostno cirkulacijo krvi
so that adequate circulation of the blood is maintained;
- če imajo določene težave s črevesjem;
- if they are hypersensitive (allergic) to ibuprofen or any of the excipients.
- če so preobčutljivi za (alergični na) ibuprofen ali katero od pomožnih snovi;
Special care should be taken with Pedea
Bodite posebno pozorni pri uporabi Pedee:
Before Pedea is given to your baby, your baby’ s heart will be examined to confirm that the ductus arteriosus is open.
Preden vaš otrok dobi Pedeo, je potrebno njegovo srce pregledati in potrditi odprt ductus arteriosus.
Pedea should not be given in the first 6 hours of life.
Pedee se ne sme dajati v prvih 6 urah življenja.
Treatment with Pedea should not be used 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, ne sme biti zdravljen s Pedeo.
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 infekcijo, ki jo že zdravijo, bo zdravnik uporabil Pedeo le po temeljitem premisleku o stanju vašega otroka.
Pedea should be carefully administered to your baby by the healthcare professional, to avoid damage to the skin and surrounding tissues.
Pedeo naj vašemu otroku v izogib poškodbam kože in okolnih tkiv aplicira izkušen zdravstveni delavec.
Ibuprofen may reduce the ability of your baby ’ s blood to clot.
Ibuprofen lahko zmanjša sposobnost strjevanja krvi vašega otroka.
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.
Pedea may reduce the amount of urine your baby passes.
Pedea lahko zmanjša količino urina, ki ga vaš otrok izloči.
If this is significant, your baby’ s treatment may be stopped until the volume of urine returns to normal.
V primeru pomembnega zmanjšanja količine urina, je potrebno zdravljenje do povrnitve količine urina na normalno vrednost prekiniti.
Pedea may be less effective in very premature babies.
Pedea je lahko pri mlajših nedonošenčkih manj učinkovita.
Using other medicines
Uporaba Pedee skupaj z drugimi zdravili:
Certain medicines, if given together with Pedea, may cause side effects.
Nekatera zdravila lahko v kombinaciji s Pedeo povzročijo neželene učinke.
Ibuprofen
Ibuprofen lahko
may reduce the effect of these medicines.
zmanjša učinkovitost teh zdravil.
Ibuprofen may
Ibuprofen
increase the anti-clotting effect of this product.
lahko poveča učinek teh zdravil.
Ibuprofen may increase the
Ibuprofen lahko poveča
risk of bleeding.
nevarnost krvavitve.
risk of bleeding in the stomach and intestines.
nevarnost krvavitev v želodcu in črevesju.
Ibuprofen may
- mogoče bodo dali vašemu otroku aminozide (skupina antibiotikov) za zdravljenje okužbe.
increase blood concentrations and thus increase the risk of toxicity on kidney and ear
Ibuprofen lahko zviša njihove koncentracije v krvi in tako zveča tveganje toksičnosti za ledvice in ušesa.
HOW PEDEA IS USED
KAKO UPORABLJATI PEDEO
Pedea will only be given to your baby in a special neonatal intensive care unit by qualified healthcare professional.
Apliciral jo bo usposobljen zdravstveni delavec.
17 A course of therapy is defined as three intravenous injections of Pedea given at 24 hour intervals.
17 Zdravljenje s Pedeo sestoji iz treh intravenskih injekcij Pedee dane v 24- urnih intervalih.
It is 10 mg/ kg for the first administration and 5 mg/ kg for the second and the third administrations.
V prvem odmerku bo prejel 10 mg/ kg, v drugem in tretjem pa po 5 mg/ kg.
If after this first course of treatment, the ductus arteriosus is not closed or re-opens, your baby ’ s doctor may decide to give a second course of treatment.
V primeru, da se po prvem zdravljenju ductus arteriosus ne zapre ali se ponovno odpre, se lahko otrokov zdravnik odloči za ponovno zdravljenje.
Like all medicines, Pedea may cause side effects.
Kot vsa zdravila ima lahko tudi Pedea neželene učinke.
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 komplikacij, ki se pogosto pojavljajo pri nedonošenčkih in komplikacij, ki so posledica bolezni.
The following side effects have been reported with Pedea:
Poročali so o naslednjih neželenih učinkih zdravljenja s Pedeo:
- problems with blood clotting resulting in bleeding disorders such as bleeding from the intestines,
- težave s strjevanjem krvi s posledičnimi krvavitvami, kot na primer krvavitve iz prebavil,
bleeding inside the skull;
krvavitve v lobanjo;
- breathing problems and bleeding in the lungs;
- težave z dihanjem in krvavitve v pljučih;
- problems with the digestive system such as obstruction and perforation of the intestine;
- težave s prebavili, kot na primer obstrukcija ali perforacija črevesja;
- kidney problems such as reduced volume of urine passed, blood in the urine and acute failure of
- težave z ledvicami, kot na primer zmanjšanje izločanja urina, kri v urinu ter akutna odpoved
the kidneys’ functions.
ledvične funkcije.
If you notice any side effects not mentioned in this leaflet, please inform your baby ’ s doctor or your pharmacist.
Če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite otrokovega zdravnika ali farmacevta.