FrancophonIA/ELRC3.0 huggingface dataset:
English: Peyona can be either used without dilution or diluted in sterile solutions for infusion such as glucose 50 mg/ml (5%) or sodium chloride 9 mg/ml (0.9%) or calcium gluconate 100 mg/ml (10%) immediately after withdrawal from the ampoule.
Maltese: Peyona jista' jintuża mingħajr dilwazzjoni jew jista' jiġi dilwit f'soluzzjonijiet sterili għall-infużjoni bħal glucose 50 mg/ml (5%) jew sodium chloride 9 mg/ml (0.9%) jew calcium gluconate 100 mg/ml (10%) hekk kif jinġibed mill-ampulla.
English: Dose of caffeine citrate (mg/kg body weight)
Maltese: Doża ta' caffeine citrate (mg/kg ta' piz tal-ġisem)
English: Citric acid monohydrate, sodium citrate, water for injections.
Maltese: TA' EĊĊIPJENTI Citric acid monohydrate, sodium citrate, ilma għall-injezzjoni.
English: Apnoea of prematurity is a diagnosis of exclusion.
Maltese: Apneja tal-prematurità hija dijanjosi ta' esklużjoni.
English: Therefore, caffeine has the potential to interact with active substances that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2.
Maltese: Għalhekk, caffeine għandu l-potenzjal li jinteraġixxi ma' sustanzi attivi li huma substrati għal CYP1A2, jinibixxu CYP1A2, jew jinduċu CYP1A2.
English: Necrotising enterocolitis is a common cause of morbidity and mortality in premature newborn infants.
Maltese: Enterokolite nekrotika hija kawża komuni ta' morbidità u mortalità fi trabi tat-twelid prematuri.
English: CHIESI FARMACEUTICI SpA Via Palermo 26/A 43122 Parma
Maltese: SpA Via Palermo 26/A 43122 Parma
English: Pharmacotherapeutic group: Psychoanaleptics, xanthine derivatives ATC code: N06BC01 Mechanism of action
Maltese: Psikoanalettiċi, derivati ta' xanthine, Kodiċi ATC:
English: Transient falls in thyroxine (T4) have been recorded in infants at the start of therapy but these are not sustained with maintained therapy.
Maltese: Tnaqqis temporanju ta' thyroxine (T4) kien irreġistrat fi trabi fil-bidu tat-terapija iżda dan mhux sostnut b'terapija kontinwa.
English: PHARMACEUTICAL FORM
Maltese: CHIESI FARMACEUTICI
English: Mean half-life (t1/2) and fraction excreted unchanged in urine (Ae) of caffeine in infants are inversely related to gestational / postmenstrual age.
Maltese: Il-half-life (t1/2) medja u l-frazzjoni mneħħija mhux mibdula fl-awrina (Ae) ta' caffeine fit-trabi hija relata b'mod invers ma' l-età ta' ġestazzjoni / postmenstrwali.
English: Caffeine therapy reduced the rate of bronchopulmonary dysplasia [odds ratio (95% CI) 0.63 (0.52 to 0.76)] and improved the rate of survival without neurodevelopmental disability [odds ratio (95 %CI) 0.77 (0.64 to 0.93)].
Maltese: Terapija b'caffeine naqqset ir-rata ta' displasja bronkopulmonari [odds ratio (95%CI) 0.63 (0.52 sa 0
English: The known pharmacology and toxicology of caffeine and other methylxanthines predict the likely adverse reactions to caffeine citrate.
Maltese: Il-farmakoloġija u t-tossikoloġija magħrufa ta' caffeine u methylxanthines oħra jbassru r-reazzjonijiet avversi probabbli ta' caffeine citrate.
English: Hepatic cytochrome P450 1A2 (CYP1A2) is involved in caffeine biotransformation in older individuals.
Maltese: F'individwi akbar iċ-ċitokromju epatiku P450 1A2 (CYP1A2) huwa nvolut fil-bijotrasformazzjoni ta'
English: Following overdose, published plasma caffeine levels have ranged from approximately 50 mg/l to 350 mg/l.
Maltese: Wara doża eċċssiva, l-livelli ta' caffeine fil-plażma ippublikati varjaw minn madwar 50 mg/l sa 350 mg/l.
English: By 9 months of age, the metabolism of caffeine approximates to that seen in adults (t1/2 = 5 hours and Ae = 1%).
Maltese: Ma' l-età ta' 9 xhur, il-metaboliżmu ta' caffeine huwa madwar dak li jidher fl-adulti (t1/2 = 5 sigħat u Ae = 1%).
English: Seizures
Maltese: Sepsi
English: Peyona is a solution for infusion and oral solution.
Maltese: Peyona huwa soluzzjoni għall-infużjoni u soluzzjoni orali.
English: The mean volume of distribution (Vd) of caffeine in infants (0.8-0.9 l/kg) is slightly higher than that in adults (0.6 L/kg).
Maltese: Il-volum medju ta' distribuzzjoni (Vd) ta' caffeine fit-trabi (0.8-0.9 l/kg) huwa kemmxejn ogħla minn dak fl-adulti (0.6
English: Caffeine is a central nervous system stimulant and seizures have been reported in cases of caffeine overdose.
Maltese: Caffeine huwa stimulant tas-sistema nervuża ċentrali u kienu irrapportati aċċessjonijiet f'każijiet ta' doża eċċessiva ta' caffeine.
English: The diuresis and electrolyte loss induced by caffeine citrate may necessitate correction of fluid and electrolyte disturbances.
Maltese: Id-dijuresi u t-telf ta' elettroliti indotta minn caffeine citrate tista teħtieġ korrezzjoni tad-disturbi tal fluwidi u l-elettroliti.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Infections and infestations Sepsis
Maltese: Infezzjonijiet u infestazzjonijiet
English: If apnoeas persisted, the daily maintenance dose could be increased to a maximum of 10 mg/kg of caffeine citrate.
Maltese: Jekk l-apneji jippersistu, id-doża tal-manteniment ta' kuljum tista' tiżdied sa massimu ta' 10 mg/kg ta' caffeine citrate.
English: Although a therapeutic plasma concentration range of caffeine has not been determined in the literature, caffeine levels in studies associated with clinical benefit ranged from 8 to 30 mg/l and no safety concerns have normally been raised with plasma levels below 50 mg/l.
Maltese: Għalkemm firxa ta' konċentrazzjonijiet terapewtiċi fil-plażma ta' caffeine ma ġietx determinata filletteratura, fi studji, livelli ta' caffeine assoċjati ma' benefiċju kliniku varjaw minn 8 sa 30 mg/l u normalment ma tqajjmu l-ebda ħsibijiet ta' sigurtà b'livelli fil-plażma taħt 50 mg/l.
English: − infants receiving co-administration of medicinal products known to interfere with caffeine metabolism (see section 4.5)
Maltese: − trabi li rċevew għoti fl-istess waqt ta' prodotti mediċinali magħrufa li jinterferixxu mal-metaboliżmu ta' caffeine (ara sezzjoni 4.5)
English: As bacterial overgrowth in the gut is associated with the development of necrotising enterocolitis, coadministration of caffeine citrate with medicinal products that suppress gastric acid secretion (antihistamine H2 receptor blockers or proton-pump inhibitors) may in theory increase the risk of necrotising enterocolitis (see section 4.4 and 4.8).
Maltese: (imblokkaturi antistamini tar-riċetturi H2 jew inibituri tal-pompi tal-protoni) teoretikament jista' jżid irriskju ta' enterokolite nekrotika (ara sezzjoni 4.4 u 4.8).
English: It is recommended that caffeine citrate administration should be stopped when the patient has 5-7 days without a significant apnoeic attack.
Maltese: Huwa rrakkomandat li l-għoti ta' caffeine citrate jitwaqqaf meta l-pazjent ikollu 5-7 ijiem mingħajr attakk sinifikanti ta' apneja.
English: Caffeine was shown to be devoid of mutagenic and oncogenic risk.
Maltese: Caffeine intwera li m'għandux riskju mutaġeniku u onkoġeniku.
English: This medicine has been shown to reduce the number of episodes of interrupted breathing in premature newborns.
Maltese: Din il-mediċina ġie muri li tnaqqas in-numru ta' episodji ta' interruzzjoni fin-nifs fi trabi tat-twelid prematuri.
English: Peyona is used in the treatment of interrupted breathing in premature babies (primary apnoea of premature newborns).
Maltese: Peyona jintuża fil-kura ta' interruzzjoni fit-teħid tan-nifs fi trabi prematuri (apneja primarja ta' trabi tattwelid prematuri).
English: The maintenance dose is 5 mg per kg body weight (equivalent to 0.25 ml per kg body weight) every 24 hours.
Maltese: Id-doża ta' manteniment hija 5 mg kull kg ta' piż tal-ġisem (ekwivalenti għal 0.25 ml kull kg ta' piż tal ġisem) kull 24 siegħa.
English: In a post-authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic impairment appeared to be higher as compared to premature infants without organ impairment (see sections 4.2, 4.8 and 5.2).
Maltese: Fi studju dwar is-sigurtà li twettaq wara l-awtorizzazzjoni, il-frekwenza tarreazzjonijiet avversi f'numru żgħir ta' trabi prematuri ħafna b'indeboliment renali/epatiku deheret li kienet ogħla meta mqabbla ma' trabi prematuri mingħajr indeboliment tal-organi (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: Each ml contains 20 mg caffeine citrate (equivalent to 10 mg caffeine).
Maltese: Kull ml fih 20 mg caffeine citrate (ekwivalenti għal 10 mg caffeine).
English: Convulsions may be treated with intravenous administration of anticonvulsants (diazepam or a barbiturate such as pentobarbital sodium or phenobarbital).
Maltese: Konvulżjonijiet jistgħu jiġu kkurati b'għoti fil-vini ta' sustanzi kontra l-konvulżjonijiet (diazepam jew barbiturate bħal pentobarbital sodium jew phenobarbital).
English: 0.25 ml/kg body weight
Maltese: 0.25 ml/kg ta' piz tal-ġisem
English: After oral administration of 10 mg caffeine base/kg body weight to preterm newborn infants, the peak plasma caffeine concentration (Cmax) ranged from 6 to 10 mg/l and the mean time to reach peak concentration (tmax) ranged from 30 min to 2 h. The extent of absorption is not affected by formula feeding but tmax may be prolonged.
Maltese: Wara għoti orali ta' 10 mg ta' bażi ta' caffeine/kg ta' piż tal-ġisem lil trabi tat-twelid li twieldu qabel iż-żmien, il-konċentrazzjoni massima ta' caffeine fil-plażma (Cmax) varjat minn 6 sa 10 mg/l u l-ħin medju sabiex tintlaħaq konċentrazzjoni massima (tmax) varjat minn 30 min sa 2 h.
English: - That the medicinal product should be used immediately after opening the ampoule and unused portions left in the ampoule should be discarded - That baseline plasma levels may need measuring because of an increased risk of toxicity if o The neonate has been previously treated with theophylline o The mother has been consuming large amounts of caffeine prior to delivery or breast feeding - That caffeine and theophylline should not be used concurrently - That if caffeine and doxapram are used concurrently, the patient should be closely monitored - That additional plasma caffeine monitoring and dosage adjustment may be necessary in at risk situations such as preterm infants: o With cholestatic hepatitis o With significant renal impairment o With seizure disorders o With cardiac disease o less than 28 weeks gestational age and/or body weight <1000g particularly when receiving parenteral nutrition o with co-administration of medicinal products known to interfere with caffeine metabolism - That cardiac disorders (including arrhythmias) may arise in newborn infants with pre-existing cardiac disease - That all suspected adverse reactions should be reported in accordance with national reporting requirements - In particular, if convulsions, seizures, necrotising enterocolitis, symptoms and signs of caffeine withdrawal, medically abnormal decrease in infant weight gain or interactions with other medicines are suspected as being associated with the use of caffeine citrate, these should be reported to <insert local name and address of Chiesi Farmaceutici S.p.A.>
Maltese: Il-kard għandu jkun fiha l-elementi ewlenin li ġejjin u trid tkun ipprovduta fit-taqsimiet kollha talkura intensiva għal trabi tat-twelid fejn il-prodott mediċinali x'aktarx li jkun ser jintuża malli jibda jinbiegħ il-prodott mediċinali: - Li Peyona hu għall-kura ta' apnea primarja - Li l-kura b'Peyona trid tkun ipprovduta f'taqsima tal-kura intensiva għal trabi tat-twelid u tinbeda u tiġi ssorveljata minn tabib b'esperjenza fil-kura intensiva ta' trabi tat-twelid
English: There are reports of a possible association between the use of methylxanthines and development of necrotising enterocolitis.
Maltese: Hemm rapporti ta' assoċjazzjoni possibli bejn l-użu ta' methylxanthines u l-iżvilupp ta' enterokolite nekrotika.
English: Peyona 20 mg/ml solution for infusion and oral solution
Maltese: IL-PRODOTT MEDIĊINALI Peyona 20 mg/ml soluzzjoni għall-infużjoni u soluzzjoni orali
English: Caffeine citrate can be administered by intravenous infusion and by the oral route.
Maltese: Caffeine citrate jista' jingħata permezz ta' infużjoni fil-vini u mir-rotta orali.
English: The clinical efficacy of caffeine citrate was assessed in a multicentre, randomised, double-blind study that compared caffeine citrate to placebo in 85 preterm infants (gestational age 28 to <33 weeks) with apnoea of prematurity.
Maltese: L-effikaċja klinika ta' caffeine citrate kienet stmata fi studju multicentre, randomised u double-blind li qabbel caffeine citrate ma' plaċebo f'85 tarbija li twieldu qabel iż-żmien (età ta' ġestazzjoni ta' 28 sa <33
English: Contents of the pack and other information What Peyona contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Peyona
English: Uncommon reported side effects (may affect up to 1 in 100 people) - stimulation of central nervous system such as convulsion - cardiac disorders such as irregular heart beat (arrhythmia)
Maltese: Effetti sekondarji rrappurtati b'mod mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) - stimulazzjoni tas-sistema nervuża ċentrali bħal konvulżjoni
English: * Beginning 24 hours after the loading dose
Maltese: * Tinbeda 24 siegħa wara d-doża għolja tal-bidu
English: Necrotising enterocolitis
Maltese: Sapport mhux invażiv
English: In a post-authorisation safety study on 506 preterm infants treated with Peyona, safety data have been collected in 31 very premature infants with renal/hepatic impairment.
Maltese: Fi studju dwar is-sigurtà li twettaq wara l-awtorizzazzjoni fuq 506 trabi prematuri kkurati b'Peyona, dejta dwar is-sigurtà kient miġbura dwar 31 tarbija prematura ħafna b'indeboliment renali/epatiku.
English: Urine output increased, urine sodium and calcium increased, haemoglobin decreased, thyroxine decreased
Maltese: Żjieda fl-awrina, żjieda ta' sodium u calcium fl-awrina, tnaqqis flemoglobina, thyroxine imnaqqas
English: Clear, colourless, aqueous solution at pH=4.7.
Maltese: Soluzzjoni milwiema, ċara u bla kulur f'pH=4
English: After an interval of 24 hours, maintenance doses of 5 mg per kg body weight may be administered by slow intravenous infusion over 10 minutes every 24 hours.
Maltese: Wara intervall ta' 24 siegħa, jistgħu jingħataw dożi ta' manteniment ta' 5 mg kull kg ta' piz tal-ġisem permezz ta' infużjoni bil-mod fil-vini fuq medda ta' 10 minuti kull 24 siegħa.
English: The protocol allowed infants to be “rescued” with open-label caffeine citrate treatment if their apnoea remained uncontrolled.
Maltese: Jekk l-apneja baqgħet bla ma ġiet ikkontrollata l-protokoll ippermetta li t-trabi jiġu “salvati” b'kura open-label ta' caffeine citrate.
English: In the presence of renal impairment, there is increased potential for accumulation.
Maltese: Fil-preżenza ta' indeboliment renali, hemm potenzjal miżjud għall-akkumulazzjoni.
English: In adults, the mean plasma protein binding in vitro is reported to be approximately 36%.
Maltese: Fl-adulti, il-medja tat-twaħħil mal-proteini fil-plażma in vitro hija rrapportata li hija madwar 36%.
English: Signs and symptoms reported in the literature after caffeine overdose in preterm infants include hyperglycaemia, hypokalaemia, fine tremor of the extremities, restlessness, hypertonia, opisthotonus, tonic clonic movements, seizures, tachypnoea, tachycardia, vomiting, gastric irritation, gastrointestinal haemorrhage, pyrexia, jitteriness, increased blood urea and increased white blood cell count, non-purposeful jaw and lip movements.
Maltese: opisthotonus, movimenti toniċi kloniċi, aċċessjonijiet, takiapneja, takikardija, rimettar, irritazzjoni gastrika, emorraġija gastro-intestinali, deni, nervożiżmu, żjieda tal-urea fid-demm u żjieda fl-għadd ta'
English: − infants with hepatic and renal impairment (see sections 4.4 and 5.2)
Maltese: partikularment meta jkunu qed jirċievu nutrizzjoni parenterali − trabi b'indeboliment epatiku jew renali (ara sezzjonijiet 4.4 u 5.2)
English: A large multicentre study (n=2006) investigating long-term outcome of premature infants treated with caffeine citrate (see section 5.1) did not show an increased frequency of necrotising enterocolitis in the caffeine group when compared to placebo.
Maltese: (n=2006) li nvestiga ir-riżultat fit-tul ta' trabi li twieldu qabel iż-żmien kkurati b'caffeine citrate (ara sezzjoni 5.1) ma weriex żjieda fil-frekwenza ta' enterokolite nekrotika fil-grupp ta' caffeine meta mqabbel mal-plaċebo.
English: If your baby has 5 to 7 days without apnoea attacks, the doctor will stop the treatment.
Maltese: Jekk it-tarbija tiegħek ikollha minn 5 sa 7 ijiem mingħajr attakki ta' apnea, it-tabib ser iwaqqaf il-kura.
English: Effects described include central nervous system (CNS) stimulation such as convulsion, irritability, restlessness and jitteriness, cardiac effects such as tachycardia, arrhythmia, hypertension and increased stroke volume, metabolism and nutrition disorders such as hyperglycaemia.
Maltese: (CNS) bħal konvulżjoni, irritabilità, aġitazzjoni u nervożiżmu, effetti kardijaċi bħal takikardija, arritmija, pressjoni għolja u żjieda fil-volum ta' demm ippumpjat minn ventriklu wieħed, disturbi fil-metaboliżmu u n-nutrizzjoni bħal ipergliċemija.
English: In a post authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic imparment appeared to be higher as compared to premature infants without organ impairment (see sections 4.4 and 4.8).
Maltese: Fi studju dwar is-sigurtà li twettaq wara l-awtorizzazzjoni, il-frekwenza tar-reazzjonijiet avversi f'numru żgħir ta' trabi prematuri ħafna b'indeboliment renali/epatiku deheret li kienet ogħla meta mqabbla ma' trabi prematuri mingħajr indeboliment tal-organi (ara sezzjonijiet 4.4 u 4.8).
English: Package leaflet: Information for the user Peyona 20 mg/ml solution for infusion and oral solution caffeine citrate
Maltese: Fuljett ta' tagħrif: informazzjoni għall-utent Peyona 20 mg/ml soluzzjoni għall-infużjoni u soluzzjoni orali caffeine citrate
English: This medicine may increase the risk for serious intestinal disease with bloody stools (necrotising enterocolitis) when administered with medicines used to treat gastric disease (such as antihistamine H2 receptor blockers or proton-pump inhibitors that reduces gastric acid secretion).
Maltese: meta tingħata ma' mediċini li jintużaw għall-kura ta' mard ta' l-istonku (bħal imblokkaturi antistamini tar riċetturi H2 jew inibituri tal-pompi tal-protoni li jnaqqsu t-tnixxija ta' aċidu gastriku).
English: Rare reported side effects (may affect up to 1 in 1,000 people) - allergic reactions
Maltese: Effetti sekondarji rrappurtati b'mod rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000)
English: Other causes of apnoea (e.g., central nervous system disorders, primary lung disease, anaemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnoea) should be ruled out or properly treated prior to initiation of treatment with caffeine citrate.
Maltese: Raġunijiet oħra ta' apneja (eż., disturbi fis-sistema nervuża ċentrali, mard primarju tal-pulmun, anemija, sepsi, disturbi metaboliċi, anormalitajiet kardjovaskulari, jew apneja ostruttiva) għandhom jiġu esklużi jew ikkurati kif jixraq qabel tinbeda kura b'caffeine citrate.
English: Other medicines and Peyona
Maltese: Mediċini oħra u Peyona
English: Each 3 ml ampoule contains 60 mg caffeine citrate (equivalent to 30 mg of caffeine base).
Maltese: Kull ampulla ta' 3 ml fiha 60 mg caffeine citrate (ekwivalenti għal 30 mg caffeine).
English: In preterm newborn infants with insufficient clinical response to the recommended loading dose, a second loading dose of 10 -20 mg/kg maximum may be given after 24 hours.
Maltese: Fi trabi tat-twelid li twieldu qabel iż-żmien b'rispons kliniku mhux suffiċjenti għad-doża għolja tal-bidu, tista' tingħata doża għolja oħra ta' massimu ta' 10-20 mg/kg wara 24 siegħa.
English: A maintenance daily dose of 5 mg/kg caffeine citrate was then administered either intravenously or orally (through a feeding tube) for up to 10-12 days.
Maltese: Wara doża ta' manteniment ta' kuljum ta' 5 mg/kg caffeine citrate ingħatat fil-vini jew mill-ħalq (permezz ta' tubu ta' l-ikel) sa 10-12-il ġurnata.
English: Manufacturer (Batch release)
Maltese: Manifattur (Ħruġ tal-lott)
English: In premature infants with cholestatic hepatitis a prolonged caffeine elimination half-life with an increase of plasma levels above the normal limit of variation has been found suggesting a particular caution in the dosage of these patients (see sections 4.2 and 4.4).
Maltese: Fi trabi tat-twelid prematuri b'epatite kolestatika half-life ta' eliminazzjoni ta' caffeine mtawwla b'żjieda fil-livelli fil-plażma 'l fuq mil-limitu normali ta' varjazzjoni instabet li tissuġġerixxi attenzjoni partikolari fid-dożaġġ ta' dawn il-pazjenti (ara sezzjonijiet 4.2 u 4.4).
English: Available evidence does not indicate any adverse long-term reactions of neonatal caffeine therapy as regards neurodevelopmental outcome, failure to thrive or on the cardiovascular, gastrointestinal or endocrine systems.
Maltese: Evidenza disponibbli ma tindika l-ebda reazzjonijiet avversi fit-tul ta' terapija b'caffeine fi trabi tat-twelid rigward riżultat ta' żvilupp newrali, nuqqas ta' tkabbir jew fuq is-sistemi kardjovaskulari, gastrointestinali jew endokrinali.
English: Treatment of caffeine overdose is primarily symptomatic and supportive.
Maltese: Ġestjoni Kura ta' doża eċċessiva ta' caffeine hija primarjament sintomatika u ta' sapport.
English: Where clinically indicated, caffeine plasma levels should be monitored.
Maltese: Fejn ikun klinikament indikat, il-livelli ta' kaffeina fil-plażma għandhom jiġu mmonitorjati.
English: Each ml contains 20 mg caffeine citrate (equivalent to 10 mg/ml of caffeine base).
Maltese: Kull ml fih 20 mg caffeine citrate (ekwivalenti għal 10 mg/ml ta' caffeine bħala bażi).
English: Peyona should be used with caution.
Maltese: Peyona għandu jintuża b'attenzjoni.
English: Absorption
Maltese: manteniment
English: Ear and labyrinth disorders Deafness
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Increased left ventricular output and increased stroke volume
Maltese: demm ippumpjat minn ventriklu wieħed.
English: For detailed information refer to the enclosed Summary of Product Characteristics of PEYONA.
Maltese: Għal informazzjoni dettaljati irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott meħmuż ta' PEYONA.
English: There is evidence that caffeine causes tachyarrhythmias in susceptible individuals.
Maltese: Hemm evidenza li caffeine jikkawża takiarritmija f'individwi suxxettibli.
English: Peyona 20 mg/ml solution for infusion and oral solution Caffeine citrate (equivalent to 10 mg/ml of caffeine base) IV/oral use
Maltese: Peyona 20 mg/ml soluzzjoni għall-infużjoni u soluzzjoni orali Caffeine citrate
English: The size and direction of caffeine effect on death and disability differed depending on the degree of respiratory support infants needed at randomisation, indicating more benefit for the supported infants [odds ratio (95%CI) for death and disability, see table below].
Maltese: Id-daqs u d-direzzjoni ta' l-effett ta' caffeine fuq il-mewt u d-diżabilità kienu differenti skond il-grad ta' sapport respiratorju li t-trabi kellhom bżonn fir-randomisation, u dan jindika aktar benefiċċju għat-trabi li kienu sapportjati [odds ratio (95%CI) għall-mewt u diżabilità, ara t-tabella taħt].
English: Where doubt exists about possible interactions, plasma caffeine concentrations should be measured.
Maltese: Meta jkun hemm dubju dwar l-interazzjonijiet possibli, għandhom jitkejjlu l-konċentrazzjonijiet ta' caffeine filplażma.