FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: Fi prova kurattiva klinika li kienet tinvolvi 175 tarbija mwielda qabel iż-żmien b'inqas minn 35 ġimgħa ta' ġestazzjoni, l-inċidenza ta' displażja bronkopulmonari fis-36 ġimgħa ta' età ta' wara lkonċepiment kienet ta' 13/81 (16%) għal indomethacin kontra 23/94 (24%) għal ibuprofen.
English: - corticosteroids: ibuprofen may increase the risk of gastrointestinal bleeding.
Maltese: - kortikosterojdi: ibuprofen jista' jżid ir-riskju ta' fsada gastro-intestinali.
English: Excipients: trometamol, sodium chloride, sodium hydroxide, hydrochloric acid 25%, water for injections.
Maltese: Sustanzi mhux attivi: trometamol, sodium chloride, sodium hydroxide, hydrochloric acid 25%, ilma għall-injezzjonijiet.
English: Pedea should be administered as a short infusion over 15 minutes, preferably undiluted.
Maltese: Pedea għandha tingħata bħala infużjoni qasira fuq 15-il minuta, preferibbilment mhux dilwita.
English: However, overdose has been described in infants and children administered oral ibuprofen: CNS depression, seizures, gastrointestinal disturbances, bradycardia, hypotension, apnoea, abnormal renal function, haematuria have been observed.
Maltese: Madankollu, doża eċċessiva ġiet deskritta fi trabi u tfal li ġew mogħtija ibuprofen b'mod orali: ġew osservati depressjoni tas-sistema nervuża ċentrali (CNS), aċċessjonijiet, disturbi gastro-intestinali, bradikardija, pressjoni baxxa, apneja, funzjoni tal-kliewi anormali u ematurja.
English: Not relevant
Maltese: Mhux rilevanti
English: Solution for injection 4 x 2 ml ampoules
Maltese: Soluzzjoni għall-injezzjoni 4 kunjetti x 2 ml
English: Excipients: each ml contains 7.5 mg of sodium.
Maltese: Sustanzi mhux attivi: kull ml fih 7.5 mg ta' sodium.
English: 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)
Maltese: Il-frekwenza tal-effetti sekondarji possibbli elenkati hawn taħt hi definita bl-użu tal-konvenzjoni li ġejja: komuni ħafna (jaffettwaw iktar minn utent 1 minn kull 10) komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100) mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1,000) rari ħafna (jaffettwaw inqas minn utent 1 minn kull 10,000) mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)
English: In this leaflet:
Maltese: Mhux magħruf:
English: The active substance in Pedea is ibuprofen.
Maltese: Is-sustanza attiva f'Pedea hi ibuprofen.
English: - aminoglycosides: since ibuprofen may decrease the clearance of aminoglycosides, their coadministration may increase the risk of nephrotoxicity and ototoxicity (see section 4.4).
Maltese: - aminoglycosides: imbilli ibuprofen jista' jnaqqas ir-rata ta' tneħħija ta' aminoglycosides, l-għoti flimkien tagħhom jista jżid r-riskju ta' nefrotossiċità u ototossiċità (ara sezzjoni 4.4).
English: Detailed information on this product is available on the web site of the European medicines Agency (EMEA) http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini (EMEA): http://www.emea.europa.eu
English: - Pedea may be less effective in very premature babies less than 27 weeks of gestational age.
Maltese: - Pedea tista' tkun inqas effettiva fi trabi li huma prematuri ħafna li għandhom età ta' tqala ta' inqas minn 27 ġimgħa.
English: GLASS AMPOULE LABEL
Maltese: GĦAMLA KWALITATTIVA
English: The medical term for this condition is ‘patent ductus arteriosus', i.e. an open ductus arteriosus.
Maltese: It-terminoloġija medika għal din is-sitwazzjoni tissejjaħ ‘patent ductus arteriosus', jiġifieri ductus arteriosus miftuħ.
English: HOW TO STORE PEDEA
Maltese: X'fih Pedea
English: Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity.
Maltese: Ibuprofen hija mediċina anti-infjammatorja tat-tip mhux steroid (NSAID) li għanda attività antiinfjammatorja, analġeżika u kontra d-deni.
English: Common: Intraventricular haemorrhage, Periventricular leukomalacia
Maltese: Komuni: Emorraġija intraventrikulari, Lewkomalaċja periventrikulari
English: Uncommon: - Acute failure of the kidney's functions - Bleeding in the intestine - Below normal oxygen content in the arterial blood (hypoxemia)
Maltese: Mhux komuni: - Insuffiċjenza akuta tal-funzjonijiet tal-kliewi - Fsada fl-imsaren - Kontenut tal-ossiġnu taħt in-normal fid-demm arterjali (hypoxemia)
English: - Hypersensitivity to the active substance or to any of the excipients; - Life-threatening infection; - Active bleeding, especially intracranial or gastrointestinal haemorrhage; - Thrombocytopenia or coagulation defects; - Significant impairment of renal function; - Congenital heart disease in which patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g. pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta); - Known or suspected necrotising enterocolitis;
Maltese: - Tromboċitopenja jew problemi ta' koagulazzjoni; - Indeboliment sinifikanti tal-funzjoni renali; - Mard tal-qalb konġenitali li fih il-patency ta' ductus arteriosus huwa meħtieġ għall-ċirkolazzjoni tad-demm pulmonari jew sistemiku sodisfaċenti (eż. atreżja pulmonari, tetraloġija serja ta' Fallot, kowarktazzjoni serja ta' l-aorta); - Enterokolite nekrotika magħrufa jew suspettata;
English: Very common: Bronchopulmonary dysplasia* Common: Pulmonary haemorrhage Uncommon: Hypoxemia*
Maltese: Displażja bronkopulmonari* Komuni: Emorraġija pulmonari
English: Common: Necrotizing enterocolitis, Intestinal perforation
Maltese: Komuni: Enterokolite nekrotika, Perforazzjoni flimsaren
English: • Risk Management Plan (RMP) Not applicable.
Maltese: • Pjan tal-immaniġġar tar-riskju (RMP) Mhux applikabbli.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Maltese: Reazzjonijiet avversi rrapportati huma elenkati hawn isfel, skont is-sistema tal-klassifika ta' l-organi u skont il-frekwenza.
English: Pedea should be administered carefully to avoid extravasation and potential resultant irritation to tissues.
Maltese: Pedea għandha tingħata b'attenzjoni biex tevita l-ekstravażazzjoni u l-irritazzjoni potenzjali fit-tessuti.
English: Ibuprofen is a non selective inhibitor of cyclooxygenase, leading to reduced synthesis of prostaglandins.
Maltese: Ibuprofen huwa impeditur mhux selettiv ta' cyclo-oxygenase, li jwassal biex inaqqas is-sintesi ta' prostaglandins.
English: Each ml contains 5 mg ibuprofen.
Maltese: U KWANTITATTIVA Kull ml tas-soluzzjoni fih 5 mg ibuprofen.
English: Date of first authorisation: 29 July 2004 Date of renewal: 29 July 2009
Maltese: Data ta' l-aħħar tiġdid: 29 ta' Lulju 2009
English: Each 2 ml ampoule contains 10 mg ibuprofen.
Maltese: Kull kunjett ta' 2 ml fiha 10 mg ibuprofen.
English: Each ml contains 5 mg ibuprofen Each ampoule of 2 ml contains 10 mg ibuprofen
Maltese: Kull ml fih 5 mg ibuprofen Kull kunjett ta' 2 ml fiha 10 mg ibuprofen
English: Pedea 5 mg/ml solution for injection
Maltese: Pedea 5 mg/ml soluzzjoni għall-injezzjoni
English: This medicinal product contains less than 1 mmol sodium (15 mg) per 2 ml, i.e. essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodium (15 mg) f'kull 2 ml, i.e. hu essenzjalment ‘ħieles mis-sodium'.
English: Pedea 5mg/ml solution for injection Ibuprofen
Maltese: Pedea 5mg/ml soluzzjoni għall-injezzjoni Ibuprofen
English: Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended.
Maltese: Għalhekk, għal asepsi tal-kunjett qabel l-użu, huwa rakkomandat l-użu ta' ethanol 60% jew isopropyl alcohol 70%.
English: Elimination rate is markedly lower than in older children and adults, with an elimination half-life estimated at approximately 30 hours (16-43).
Maltese: Ir-rata tal-eliminazzjoni hi iktar baxxa b'mod notevoli milli fi tfal li jkollhom iktar żmien u fl-adulti, b'half-life tal-eliminazzjoni stmata li hi ta' madwar 30 siegħa (16-43).
English: 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.
Maltese: Fi studju għal rispons għal Pedea f'40 tarbija mwielda qabel iż-żmien, ir-rata ta' għeluq tad-ductus arteriosus li hu assoċjat mal-kors tad-doża ta'10-5-5 mg/kg kienet ta' 75% (6/8) fi trabi għadhom jitwieldu wara 27-29-il ġimgħa ta' ġestazzjoni u 33% (2/6) fi trabi għadhom jitwieldu wara 24-26-il ġimgħa ta' ġestazzjoni.
English: If the condition is unchanged after the second course of therapy, surgery of the PDA may then be necessary.
Maltese: Jekk il-kondizzjoni ma tinbidilx wara t-tieni kors ta' terapija, jista' jkun hemm bżonn ta' operazzjoni għal PDA.
English: Residual concentrations are around 1015 mg/l 24 hours after the last dose of 5 mg/kg.
Maltese: Konċentrazzjonijiet residwi huma ta' madwar 10-15 mg/l 24 siegħa wara l-aħħar doża ta'5 mg/kg.
English: - nitric oxide: since both medicinal products inhibit platelet function, their combination may in theory increase the risk of bleeding.
Maltese: - Nitric oxide: billi ż-żewġ prodotti mediċinali jimpedixxu l-funzjoni tal-plejtlets, il-kombinazzjoni tagħhom tista' b'mod teoriku iżid ir-riskju ta' fsada.
English: 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.
Maltese: Kien hemm biss mewta waħda li ġiet ippubblikata: wara doża eċċessiva ta' 469 mg/kg, wild ta' 16-il xahar żvilupap episodju apnejaku b'aċċessjonijiet u pulmonite ta' aspirazzjoni fatali.
English: 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);
Maltese: Tużax Pedea - jekk it-tarbija tiegħek hi allerġika (tbati minn sensittività eċċessiva) għal ibuprofen jew sustanzi oħra ta' Pedea; - jekk it-tarbija tiegħek għandha infezzjoni li tista' tkun fatali li għadha ma ġietx ittrattata; - jekk it-tarbija tiegħek għandha fsada, speċjalment jekk il-fsada tinsab fil-kranju jew fl-imsaren; - jekk it-tarbija tiegħek għandha tnaqqis fiċ-ċelluli tad-demm imsejħa plejtlits (tromboċitopenija)
English: Pedea 5 mg/ml solution for injection Ibuprofen
Maltese: Pedea 5 mg/ml soluzzjoni għall-injezzjoni Ibuprofen
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France
Maltese: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800
English: Since ibuprofen was shown in vitro to displace bilirubin from its binding site to albumin, the risk of bilirubin encephalopathy in premature newborn infants may be increased (see section 5.2).
Maltese: Billi ntwera li ibuprofen in vitro li jneħħi bilirubin mill-post ta' twaħħil ma' albumin, hemm riskju akbar fi trabi li twieldu qabel iż-żmien ta' enċefelopatija ta' bilirubin (ara sezzjoni 5.2).
English: Very common: Thrombocytopenia, Neutropenia
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni ħafna: Tromboċitopenja, Newtropenja Disturbi fis-sistema nervuża
English: Common: Oliguria, Fluid retention, Haematuria Uncommon: Acute renal failure
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Komuni: Oligurja, Żamma ta' fluwidu, Ematurja Mhux komuni: Insuffiċjenza renali akuta
English: In preterm newborns ibuprofen significantly reduced plasma concentrations of prostaglandins and their metabolites, particularly PGE2 and 6-keto-PGF-1-alpha. 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.
Maltese: Livelli mnaqqsa inżammu sa 72 siegħa fi trabi li għadhom jitwieldu li ħadu 3 dożi ta' ibuprofen, filwaqt li żjidiet oħra ġew osservati fit-72 siegħa wara doża waħda ta' ibuprofen.
English: Common: - Bleeding inside the skull (intraventricular haemorrhage) and brain injury (periventricular leukomalacia), - Bleeding in the lung, - Perforation of the intestine and injury of intestinal tissue (necrotizing enterocolitis), - Reduced volume of urine passed, blood in the urine, fluid retention
Maltese: Komuni: - Fsada ġol-kranju (emorraġija intraventrikulari) u ħsara fil-moħħ (lewkomalaċija periventrikulari), - Fsada fil-pulmun, - Perforazzjoni tal-imsaren u ħsara tat-tessut intestinali (enterokolite nekrotizzanti), - Tnaqqis fil-volum tal-awrina li t-tarbija tagħmel, demm fl-awrina, żamma ta' fluwidu
English: Massive overdose (up to more than 1000 mg/kg) has been reported to induce coma, metabolic acidosis, and transient renal failure.
Maltese: Kien rappurtat li doża eċċessiva sostanzjali (sa aktar minn 1000 mg/kg) twassal għal koma, aċidożi metabolika u insuffiċjenza renali għal żmien qasir.
English: - The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi l-oħra huma trometamol, sodium chloride, sodium hydroxide (għal aġġustament talpH), hydrochloric acid 25% (għal aġġustament tal-pH) u ilma għall-injezzjonijiet.
English: Batch
Maltese: Lott
English: Very common: - Decrease in the number of platelets in the blood (thrombocytopenia), - Decrease in white blood cells called neutrophils (neutropenia), - Increase in creatinine level in the blood, - Decrease in sodium level in the blood, - Breathing problems (bronchopulmonary dysplasia),
Maltese: Komuni ħafna: - Tnaqqis fin-numru ta' plejtlits fid-demm (tromboċitopenija), - Tnaqqis fiċ-ċelluli bojod tad-demm imsejħa newtrofili (newtropenija), - Żieda fil-livell tal-krejatinina fid-demm, - Tnaqqis fil-livell tas-sodium fid-demm, - Problemi biex tieħu n-nifs (displasija bronkopulmonarja),
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: 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.
Maltese: Għandu ġeneralment jingħata volum massimu ta' 80 ml/kg/jum flewwel jum ta' ħajja; dan għandu jiżdied b'mod progressiv fil-ġimgħa jew ġimgħatejn ta' wara (madwar 20 ml/kg piż ta' twelid /jum) sa volum massimu ta' 180 ml/kg piż ta' twelid/jum.
English: - your baby may be given aminosides (one family of antibiotics) to treat infection.
Maltese: - it-tarbija tiegħek tista' tingħata aminosides (familjata' antibijotiċi) sabiex tittratta l-infezzjoni.
English: - other NSAIDs: the concomitant use of more than one NSAID should be avoided because of the increased risk of adverse reactions.
Maltese: - NSAIDs oħrajn: l-użu flimkien ta' aktar minn NSAID wieħed għandu jiġi evitat minħabba r-riskju ogħla ta' reazzjonijiet avversi.
English: Careful monitoring of both renal and gastrointestinal function is recommended.
Maltese: Monitoraġġ b'attenzjoni tal-funzjoni renali u gastro-intestinali huwa rakkomandat.
English: Ibuprofen may reduce the effect of these medicines.
Maltese: Ibuprofen jista' jnaqqas l-effett ta' dawn il-mediċini.
English: Uncommon: Gastrointestinal haemorrhage Unknown: Gastric perforation
Maltese: Mhux komuni: Emorraġija gastro-intestinali
English: Use only sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution to adjust injection volume.
Maltese: Uża biss 9 mg/ml (0.9%) sodium chloride soluzzjoni għall-injezzjoni jew soluzzjoni ta' 50 mg/ml (5%) glukożju sabiex tagħmel il-volum meħtieġ ta' injezzjoni.
English: See leaflet
Maltese: Pożoloġija
English: Trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.
Maltese: Sodium hydroxide (biex jirregola l-pH), Hydrochloric acid 25% (biex jirregola l-pH), ilma għall-injezzjonijiet.
English: Conversely, a lower incidence of neonatal grade III-IV intraventricular haemorrhage and of surgical ligation was associated with prophylactic use of Pedea.
Maltese: Minn naħa l-oħra, kien hemm inċidenza mnaqqsa ta' emorraġija intraventrikulari ta' grad III-IV fi trabi għadhom jitwieldu u ta' interventi kirurġiċi għall-irbit assoċjati ma' l-użu profilattiku ta' Pedea.
English: 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.
Maltese: Qabel u wara l-għoti ta' Pedea, sabiex jiġi evitat kull kuntatt ma' soluzzjoni aċiduża l-pajp ta' infużjoni għandu jiġi mlaħlaħ għal madwar 15-il minuta b'1.5 sa 2 ml ta' 9mg/ml (0.9%) sodium chloride jew 50 mg/ml (5%) glukożju, bħala soluzzjoni għall-injezzjoni.
English: OUTER CARTON TEXT
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: Pedea 5mg/ml solution for injection is supplied in cartons of four 2 ml ampoules.
Maltese: Pedea 5mg/ml soluzzjoni għall-injezzjoni hi fornuta f'kaxxi tal-kartun ta' erba' kunjetti ta' 2 ml.
English: Ibuprofen may increase the risk of bleeding.
Maltese: Ibuprofen jista' jżid ir-riskju ta' fsada.
English: 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.
Maltese: Ibuprofen jikkompeti ma' bilirubin għall-irbit mal-albumina fis-serum ta' trabi għadhom jitwieldu u, bħala konsegwenza, il-frazzjoni ħielsa ta' bilirubin tista' tiżdied b'konċentrazzjonijiet għolja ta' ibuprofen.
English: PHARMACOLOGICAL PROPERTIES
Maltese: TAL-PRODOTT MEDIĊINALI
English: 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.
Maltese: Il-kawżalità ta' każijiet avversi rrapportati fi trabi mwielda qabel iż-żmien huwa diffiċli biex jiġi analizzat billi jista' jkun relatat ma' konsegwenzi emodinamiċi tal-patent ductus arteriosus kif ukoll l-effetti diretti ta' ibuprofen.
English: The central volume of distribution may depend on the status of the ductus and decrease as the ductus closes.
Maltese: Ilvolum ċentrali ta' distribuzzjoni jista' jiddependi fuq l-istat tad-ductus u t-tnaqqis kif id-ductus ikun qed jagħlaq.
English: 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.
Maltese: Fi prova klinika fejn Pedea ġie mogħti b'mod profilattiku fl-ewwel 6 sigħat ta' ħajja, irriżulta li fi 3 trabi li kellhom inqas minn 28 ġimgħa ta' ġestazzjoni kien hemm ipoksimja serja u pressjoni pulmonari għolja.
English: 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.
Maltese: L-użu profilattiku ta' Pedea, meta mqabbel ma' l-użu kurattiv, fl-ewwel 3 ijiem ta' ħajja (li jibdew minn 6 sigħat mit-twelid) fi trabi li twieldu qabel iż-żmien b'inqas minn 28 ġimgħa ta' ġestazzjoni, kien assoċjat ma' inċidenza ogħla ta' insuffiċjenza renali u każijiet pulmonari avversi bħal nuqqas ta' ossiġnu, pressjoni pulmonari għolja u emorraġija pulmonari.
English: Certain medicines, if given together with Pedea, may cause side effects.
Maltese: Ċertu mediċini, jekk jingħataw flimkien ma' Pedea, jistgħu jikkawżaw effetti oħra.
English: Pedea closes the ductus arteriosus by inhibiting the production of prostaglandin, a naturally occurring chemical in the body which keeps the ductus arteriosus open.
Maltese: Pedea jagħlaq id-ductus arteriosus billi jimpedixxi lproduzzjoni ta' prostaglandin, li hija sustanza naturali li tinsab fil-ġisem tiegħek li qed iżżomm idductus arteriosus miftuħ.
English: All patients recovered with conventional treatment.
Maltese: Il-pazjenti kollha rkupraw bi trattament konvenzjonali.
English: 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.
Maltese: Minkejja l-varjabilità kbira li hija osservata fil-popolazzjoni prematura, l-ogħla konċentrazzjonijiet filplażma huma mkejla madwar 35-40 mg/l wara d-doża għolja tal-bidu ta' 10mg/kg, kif ukoll wara laħħar doża ta' manteniment, tkun xi tkun l-età ta' ġestazzjoni jew wara t-twelid.
English: 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 %).
Maltese: Studji in vitro jissuġerixxu li, bħal fil-każ ta' mediċini NSAIDs oħrajn, ibuprofen jingħaqad sew ma' lalbumina fil-plażma, għalkemm dan jidher li huwa sinifikament inqas (95%) meta mqabbel ma' plażma ta' l-adulti (99%).
English: Method of administration:
Maltese: Metodu ta' kif għandu jingħata:
English: 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'.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Pedea Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodium (15 mg) f'kull 2 ml, i.e. hu essenzjalment ‘ħieles mis-sodium'.
English: A course of therapy is defined as three intravenous doses of Pedea given at 24-hour intervals.
Maltese: Kors ta' terapija huwa mfisser bħala tliet dożi ta' Pedea mogħtija ġol-vina f'intervalli ta' 24 siegħa.
English: In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
Maltese: Sabiex ma jkunx hemm bidla sostanzjali fil-pH minħabba l-preżenza ta' prodotti mediċinali aċidużi li jistgħu jibqgħu fil-pajp ta' l-infużjoni, dan ta' l-aħħar irid jiġi mlaħlaħ qabel u wara l-għoti ta' Pedea b'1.5 sa 2 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride għall-injezzjoni jew 50 mg/ml (5%) soluzzjoni ta' glukożju.
English: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Maltese: Trattament ta' ductus arteriosus evidenti, emodinamikament sinifikanti fi trabi li jitwieldu qabel iżżmien li għandhom inqas minn 34 ġimgħa ta' żmien ta' ġestazzjoni.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna:
English: Blood and lymphatic system disorders
Maltese: Sodium chloride,