FrancophonIA/ELRC3.0 huggingface dataset:
English: ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection efmoroctocog alfa (recombinant coagulation factor VIII)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni ELOCTA 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni ELOCTA 4000 IU trab u solvent għal soluzzjoni għall-injezzjoni ELOCTA 5000
English: Check the expiry date on the ELOCTA carton.
Maltese: Iċċekkja ddata ta' skadenza fuq il-kartuna ta' ELOCTA.
English: In comparison with adolescents and adults, children less than 12 years of age may have a higher clearance and a shorter half-life which is consistent with observations of other coagulation factors.
Maltese: Meta mqabbla mal-adolexxenti u adulti, tfal li għandhom inqas minn 12-il sena jista' jkollhom tneħħija ogħla u half-life iqsar.
English: Weekly prophylaxis: Median annual factor consumption was 3805 IU/kg (min 3353, max 6196) in Study I and 3510 IU/kg (min 2758, max 3984) in Study III.
Maltese: Il-konsum annwali medjan tal-fattur kien ta' 3805 IU/kg (minimu 3353, massimu 6196) fi Studju I u 3510
English: Median total time on study II+III was 3.4 years and median no of exposure days was 332.
Maltese: Iżżmien totali medjan fi studju II+III kien ta' 3.4 snin u n-numru medjan ta' jiem ta' esponiment kien ta'
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of the aPTT reagent and the reference standard used in the assay.
Maltese: It-tabib tiegħek se jwettaq testijiet adattati tal-laboratorju biex jaċċerta li inti jkollok livelli adegwati ta' fattur VIII fid-demm tiegħek.
English: Upon activation of the clotting cascade, factor VIII is converted to activated factor VIII and released from von Willebrand factor.
Maltese: Malli tiġi attivata l-kaskata tal-għaqid tad-demm, fattur VIII jinbidel għal fattur VIII attivat u jintreħa mill-fattur von Willebrand.
English: Headache Dizziness Dysgeusia
Maltese: sakemm it-theddida tgħaddi.
English: Treatment of bleeding: 2490 bleeding events were treated during Study I and III with a median dose of 43.8 IU/kg (min 13.0, max 172.8) to control each bleed.
Maltese: Trattament ta' ħruġ ta' demm: 2490 avveniment ta' ħruġ ta' demm kienu ttrattati matul Studju I u III b'doża medjana ta' 43.8 IU/kg (minimu 13.0, massimu 172.8) biex jiġi kkontrollat kull ħruġ ta' demm.
English: ELOCTA 5000 IU powder and solvent for solution for injection Each vial contains nominally 5000 IU efmoroctocog alfa.
Maltese: ELOCTA 4000 IU trab u solvent għal soluzzjoni għall-injezzjoni ELOCTA 5000
English: Median annual factor consumption was 5572 IU/kg (min 3849, max 7035) in Study I and 4456 IU/kg (min 3563, max 8011) in Study III.
Maltese: Il-konsum annwali medjan tal-fattur kien ta' 5572 IU/kg (minimu 3849, massimu 7035) fi Studju I u 4456 IU/kg (minimu 3563, massimu 8011) fi Studju III. L-ABR medjana rispettiva kienet ta' 1.92 (minimu 0, massimu 7.1) u 1.25 (minimu 0, massimu 9.5).
English: Hypersensitivity or allergic reactions (which may include swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hypotension, lethargy, nausea, restlessness, tachycardia) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu nefħa tal-wiċċ, raxx, ħorriqija, tagħfis fis-sider u diffikultà biex tieħu n-nifs, ħruq u tingiż fis-sit tal-infużjoni, tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, pressjoni baxxa, letarġija, dardir, nuqqas ta' kwiet, takikardija) ġew osservati b'mod rari u jistgħu, f'ċerti każijiet, jaggravaw għal anafilassi severa (li tinkludi xokk).
English: Treatment of bleeding: 447 bleeding events were treated during Study II and III with a median dose of 63 IU/kg (min 28, max 186) to control each bleed.
Maltese: Trattament ta' ħruġ ta' demm: 447 avveniment ta' ħruġ ta' demm kienu ttrattati matul Studju II u III b'doża medjana ta' 63 IU/kg (minimu 28, massimu 186) biex jiġi kkontrollat kull ħruġ ta' demm.
English: On-demand treatment
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Dosing of up to 80 IU/kg and a dosing interval as short as 2 days was allowed and used in a limited number of patients.
Maltese: Dożaġġ ta' sa 80 IU/kg u intervall tad-dożaġġ li kien sa jumejn biss, ġew permessi u użati f'numru limitat ta'
English: Remove the clear plastic protective cover from the needle.
Maltese: Neħħi l-għatu protettiv tal-plastik ċar minn fuq il-labra.
English: PC: SN: NN:
Maltese: Profilassi, età <6 snin:
English: Solvent for ELOCTA water for injections
Maltese: Solvent Ilma għall-injezzjonijiet
English: The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay against an in-house standard that is referenced to the WHO factor VIII standard.
Maltese: Ewropea kontra standard in-house li huwa referenzjat mal-istandard ta' fattur VIII tal-WHO.
English: ELOCTA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU efmoroctocog alfa.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni ELOCTA 2000
English: ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII, Fc fusion protein.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni efmoroctocog alfa fattur VIII tal-koagulazzjoni rikombinanti, proteina tal-fużjoni Fc
English: Study I enrolled 165 previously treated male patients (12 to 65 years of age) with severe haemophilia A. Subjects on prophylaxis regimens prior to entering the study were assigned to the individualised prophylaxis arm.
Maltese: Studju I irreġistra total ta' 165 pazjenti rġiel li ġew ikkurati fil-passat (minn 12 sa 65 sena) b'emofilija A severa.
English: Protect the prepared solution from direct sunlight.
Maltese: Ilqa' s-soluzzjoni ppreparata minn xemx diretta.
English: In case of anaphylactic shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk anafilattiku, għandha tiġi implimentata kura medika standard għal xokk.
English: Turn the plunger rod firmly clockwise until it is securely seated in the syringe plunger.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT
English: Hypertension Hot flush Angiopathy2
Maltese: Użu fit-tfal u fl-adolexxenti
English: ELOCTA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU efmoroctocog alfa.
Maltese: IU trab għall-injezzjoni ELOCTA 1000 IU trab għall-injezzjoni ELOCTA 1500
English: Recording of batch number
Maltese: Reġistrazzjoni tan-numru tal-lott
English: Note: If the solution is not to be used immediately, the syringe cap should be carefully put back on the syringe tip.
Maltese: Solvent: ilma għall-injezzjonijiet, soluzzjoni ċara u bla kulur.
English: ELOCTA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU efmoroctocog alfa.
Maltese: ELOCTA 1000 IU trab u solvent għal soluzzjoni għall-injezzjoni
English: ELOCTA 6000 IU powder and solvent for solution for injection Each vial contains nominally 6000 IU efmoroctocog alfa.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni ELOCTA 6000
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Maltese: Unità Internazzjonali (IU) waħda ta' attività ta' fattur VIII rikombinanti Fc hi ekwivalenti għal dik ilkwantità ta' fattur VIII f'mL wieħed ta' plażma normali tal-bniedem.
English: In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.
Maltese: attività mogħti ta' plażma (f'% tan-normal jew f'IU/dL) fil-perjodu korrispondenti.
English: Respective median ABR was 2.01 (min 0, max 27.2) and 1.59 (min 0, max 8.0).
Maltese: IU/kg) fi Studju II u 4990 IU/kg (minimu 3856, massimu 9527) fi Studju III. L-ABR medjana rispettiva kienet ta' 2.01 (minimu 0, massimu 27.2) u 1.59 (minimu 0, massimu 8.0).
English: Detach the syringe from the vial adapter by gently pulling and turning the vial counterclockwise.
Maltese: Iġbed lura bil mod il-lasta tal-planġer biex tiġbed lura s-soluzzjoni kollha minn ġol-adapter tal-kunjett għal ġos-siringa.
English: The pharmacokinetic parameters from the chromogenic assay data were similar to those derived for the one-stage assay.
Maltese: Il-parametri farmakokinetiċi minn dejta ta' assaġġ kromoġeniku kienu simili għal dawk miksuba għall-assaġġ ta' stadju wieħed.
English: Median annual factor consumption was 4700 IU/kg (min 3819, max 8230 IU/kg) in Study II and 4990 IU/kg (min 3856, max 9527) in Study III.
Maltese: Il-konsum annwali medjan tal-fattur kien ta' 4700 IU/kg (minimu 3819, massimu 8230
English: You must contact your doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, rash, generalised itching, hives, tightness of the chest, difficulty breathing, burning and stinging at the injection site, chills, flushing, headache, low blood pressure, general feeling of being unwell, nausea, restlessness and fast heartbeat, feeling dizzy or loss of consciousness.
Maltese: Il-pazjenti għandhom jiġu infurmati dwar sinjali ta' reazzjonijiet ta' sensittività eċċessiva li jinkludu ħorriqija, urtikarja ġeneralizzata, tagħfis fis-sider, tħarħir, pressjoni baxxa, u anafilassi.
English: Haemophilia A is an X-linked hereditary disorder of blood coagulation due to decreased levels of functional factor VIII and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Maltese: Emofilija A hi disturb ereditarju tal-koagulazzjoni tad-demm assoċjata ma' X, minħabba livelli mnaqqsa ta' fattur VIII funzjonali u tirriżulta fi ħruġ ta' demm fil-ġogi, fil-muskoli jew fl-organi interni, li jkun jew spontanju jew b'riżultat ta' trawma aċċidentali jew kirurġika.
English: • The CHMP considered that there is evidence from clinical and epidemiological studies indicating the benefits of the use of metformin containing medicinal products in patients with moderate renal impairment (GFR 30-59 ml/min).
Maltese: • Is-CHMP ikkunsidra li hemm evidenza minn studji kliniċi u epidemjoloġiċi li tindika l-benefiċċji talużu ta' prodotti mediċinali li fihom metformin f'pazjenti b'indeboliment tal-kliewi moderat (GFR 30-59 ml/min).
English: As there is a clear relationship between renal function and metformin exposure, a recommendation for a daily dose of 2000 mg/day and 1000 mg/day dose in patients with moderate renal impairment stages 3a and 3b, respectively, can be concluded from the data provided.
Maltese: Peress li hemm relazzjoni ċara bejn il-funzjoni tal-kliewi u l-esponiment għal metfromin, middejta pprovduta tista' tiġi konkluża rakkomandazzjoni għal doża ta' kuljum ta' 2000 mg/kuljum u doża ta' 1000 mg/kuljum f'pazjenti b'indeboliment tal-kliewi moderat ta' stadji 3a u 3b, rispettivament.
English: • The CHMP was of the view that the risk of lactic acidosis can be minimised in patients with moderate renal impairment with clear dosing recommendations, additional monitoring of GFR levels before and during treatment and updated warnings and precautions in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL).
Maltese: • Is-CHMP kien tal-fehma li r-riskju ta' aċidożi lattika jista' jitnaqqas f'pazjenti b'indeboliment talkliewi moderat b'rakkomandazzjonijiet ta' dożaġġ ċari, monitoraġġ addizzjonali tal-livelli ta' GFR qabel u waqt il-kura u twissijiet u prekawzjonijiet aġġornati fis-Sommarju tal-Karatteristiċi talProdott (SmPC) u l-Fuljett ta' Tagħrif (PL).
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration and applicant in the Member States
Maltese: Lista ta' l-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata u l-applikant fl-Istati Membri
English: 28 June 2013 EMA/385716/2013
Maltese: 28 ta' Ġunju 2013 EMA/385716/2013
English: • The pharmacokinetic profile of codeine has been studied in adults but limited information is available in children.
Maltese: • Il-profil farmakokinetiku tal-kodeina ġie studjat fl-adulti iżda fit-tfal, l-informazzjoni disponibbli hija limitata.
English: Codeine is converted into morphine in the body by an enzyme called CYP2D6.
Maltese: Il-kodeina tiġi kkonvertita f'morfina fil-ġisem permezz ta' enzima msejħa CYP2D6.
English: • Codeine is now contraindicated: in all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome and in patients of any age who are known to be CYP2D6 ultra-rapid metabolisers (up to approximately 10% of Caucasians are CYP2D6 ultra-rapid metabolisers, but prevalence differs according to racial and ethnic group), due to an increased risk of developing serious and life-threatening adverse reactions; and in women who are breastfeeding.
Maltese: • Il-kodeina issa hija kontraindikata: fil-pazjenti pedjatriċi kollha (0-18-il sena) li ssirilhom operazzjoni tat-tunsilli u/jew adenojdektomija għas-sindromu tal-apnea ostruttiva waqt l-irqad u f'pazjenti ta' kull età magħrufa li huma metabolizzaturi ultra-rapidi ta' CYP2D6 (sa madwar 10% tal-Kawkasi huma metabolizzaturi ultra-rapidi ta' CYP2D6, imma l-prevalenza tvarja skont il-grupp razzjali u etniku), minħabba żieda akbar għall-iżvilupp ta' reazzjonijiet avversi serji u ta' periklu għall-ħajja; u f'nisa li qed ireddgħu.
English: Some of the children were found to be CYP2D6 ultra-rapid metabolisers.
Maltese: Uħud mit-tfal instabu li kienu metabolizzaturi ultra-rapidi ta' CYP2D6.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: CMDh, korp li jirrappreżenta l-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards armonizzati ta' sigurtà għal mediċini awtorizzati permezz ta' proċeduri nazzjonali madwar l-UE.
English: The risk of side effects with codeine may also apply to adults.
Maltese: Ir-riskju ta' effetti sekondarji bil-kodeina jista' japplika wkoll għall-adulti.
English: • Parents and caregivers who notice any of the following symptoms in a patient given codeine should stop giving the medicine and seek medical attention immediately: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation and lack of appetite.
Maltese: • Ġenituri u persuni kuranti li jinnotaw xi sintomi minn dawn li ġejjin f'pazjent li jingħata l-kodeina għandhom jieqfu jagħtu l-mediċina u għandhom ifittxu parir mediku minnufih: teħid bil-mod jew mhux fil-fond tan-nifs, konfużjoni, ngħas, pupilli żgħar, iħossu mdardar jew jirremetti, stitikezza u nuqqas ta' aptit.
English: The available data suggest that there is a reduced ability to metabolise codeine in younger children but that the enzyme system responsible for the metabolism of codeine can be considered to be fully matured by the age of 12.
Maltese: Id-dejta disponibbli tissuġġerixxi li fi tfal iżgħar hemm kapaċità mnaqqsa li jimmetabolizzaw il-kodeina imma li l-enzima responsabbli għall-metaboliżmu tal-kodeina tista' titqies kompletament żviluppata sa 12-il sena.
English: The children who had suffered severe side effects had evidence of being ‘CYP2D6 ultra-rapid metabolisers' of codeine.
Maltese: It-tfal li kienu sofrew effetti sekondarji severi kellhom evidenza li kienu ‘metabolizzaturi ultra-rapidi ta' CYP2D6' tal-kodeina.
English: • Codeine is not recommended for use in children in whom respiratory function might be compromised as this may worsen the symptoms of morphine toxicity.
Maltese: • Il-kodeina mhijiex rakkomandata għall-użu fi tfal li fihom il-funzjoni respiratorja tista' tkun kompromessa peress li din tista' taggrava s-sintomi ta' tossiċità minħabba l-morfina.
English: Restrictions on use of codeine for pain relief in childrenCMDh endorses PRAC recommendation
Maltese: Is-CMDh qabel mal-konklużjonijiet tal-PRAC u approva r-rakkomandazzjonijiet li ġejjin:
English: Codeine is marketed as a singleingredient medicine or in combination with other substances such as aspirin or paracetamol.
Maltese: Il-kodeina hija mqiegħda fis-suq bħala mediċina b'sustanza unika jew f'kombinazzjoni ma' sustanzi oħra bħall-aspirina jew paracetamol.
English: • Six cases (including 3 with a fatal outcome) of respiratory depression in children treated with codeine at recommended doses after undergoing tonsillectomy for obstructive sleep apnoea were reviewed.
Maltese: • Sitt każijiet (inkluż 3 b'riżultati fatali) ta' dipressjoni respiratorja fi tfal li rċevew kura bil-kodeina f'dożi rakkomandati wara li saritilhom operazzjoni tat-tunsilli għal apnea ostruttiva waqt l-irqad ġew riveduti.
English: The review was initiated on 3 October 2012, at the request of the United Kingdom medicines agency under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni nbdiet fit-3 ta' Ottubru 2012, fuq talba tal-aġenzija tal-mediċini tar-Renju Unit skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: This follows a review of these medicines by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which investigated reports of serious and fatal respiratory depression in children after taking codeine for pain relief.
Maltese: Dan isegwi reviżjoni ta' dawn il-mediċini mill-Kumitat għall-Valutazzjoni tar-Riskji talFarmakoviġilanza (PRAC) tal-EMA, li investiga rapporti ta' dipressjoni respiratorja serji u fatali fit-tfal wara li ħadu l-kodeina għas-serħan mill-uġigħ.
English: These recommendations follow a review of available safety and efficacy data on codeine when used for pain relief in children, including pharmacokinetic data, clinical studies, post-marketing data in Europe and other published literature:
Maltese: Dawn ir-rakkomandazzjonijiet isegwu reviżjoni tad-dejta disponibbli dwar is-sigurtà u l-effikaċja talkodeina meta użata għas-serħan mill-uġigħ fit-tfal, inkluż dejta farmakokinetika, studji kliniċi, dejta wara t-tqegħid fis-suq fl-Ewropa u letteratura oħra ppubblikata:
English: As codeine-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Peress li mediċini li fihom il-kodeina huma kollha awtorizzati fuq livell nazzjonali, ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għarRikonoxximent Reċiproku u Proċeduri Deċentralizzati - Umani (CMDh), li adotta pożizzjoni finali.
English: In addition, a published case report described a case of respiratory depression resulting in death in a breastfed infant whose codeine-using mother was a CYP2D6 ultra-rapid metaboliser.
Maltese: Barra minn hekk, rapport ippubblikat dwar il-każ iddeskriva każ ta' dipressjoni respiratorja li wasslet għallmewt f'tarbija li kienet qed titredda', li ommha li kienet qed tuża l-kodeina kienet metabolizzatur ultra-rapidu ta' CYP2D6.
English: The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by consensus a series of risk minimisation measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.
Maltese: Il-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u Proċeduri Deċentralizzati - Umani (CMDh) approva b'kunsens serje ta' miżuri għall-minimizzazzjoni tar-riskji biex jindirizza t-tħassib dwar issigurtà b'mediċini li fihom il-kodeina meta jintużaw għall-immaniġġjar tal-uġigħ fit-tfal.
English: Some of the children who had suffered severe side effects had evidence of being ‘ultra-rapid metabolisers' of codeine.
Maltese: Uħud mit-tfal li kienu sofrew effetti sekondarji severi kellhom evidenza li kienu ‘metabolizzaturi ultrarapidi' tal-kodeina.
English: • Codeine should not be used at all in children (aged below 18 years) who undergo surgery for the removal of the tonsils or adenoids to treat obstructive sleep apnoea, as these patients are more susceptible to respiratory problems.
Maltese: • Il-kodeina m'għandha qatt tintuża fit-tfal (taħt it-18-il sena) li ssirilhom kirurġija għat-tneħħija tat tunsilli jew tal-adenojdi fil-kura tal-apnea ostruttiva waqt l-irqad, peress li dawn il-pazjenti huma aktar suxxettibbli għal problemi respiratorji.
English: • Codeine-containing medicines should only be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen, because of the risk of respiratory depression associated with codeine use.
Maltese: akut fi tfal ta' aktar minn 12-il sena, u dan biss jekk ma jistax jinkiseb serħan b'analġesiċi oħra bħal paracetamol jew ibuprofen, minħabba r-riskju ta' dipressjoni respiratorja assoċjata mal-użu tal-kodeina.
English: • All children (aged below 18 years) who undergo surgery for the removal of the tonsils or adenoids to treat obstructive sleep apnoea (frequent interruption of breathing during sleep) should not be given codeine as they are more at risk of breathing problems.
Maltese: • It-tfal kollha (taħt it-18-il sena) li ssirilhom kirurġija għat-tneħħija tat-tunsilli jew tal-adenojdi filkura tal-apnea ostruttiva waqt l-irqad (interruzzjoni frekwenti tat-teħid tan-nifs waqt l-irqad) m'għandhomx jingħataw il-kodeina peress li qegħdin f'riskju ogħla ta' problemi tan-nifs.
English: Codeine should therefore not be used in people of any age who are known to be ultra-rapid metabolisers nor in breastfeeding mothers (because codeine can pass to the baby through breast milk).
Maltese: Għalhekk, il-kodeina m'għandhiex tintuża f'persuni ta' kwalunkwe età magħrufa li huma metabolizzaturi ultra-rapidi u lanqas f'ommijiet li qed ireddgħu (minħabba li l-kodeina tista' tgħaddi lit-tarbija permezz tal-ħalib tassider).
English: • Because of a risk of breathing problems, the use of codeine medicines for pain relief in children has been restricted: these medicines are now only to be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen.
Maltese: • Minħabba riskju ta' problemi tan-nifs, l-użu ta' mediċini bil-kodeina għas-serħan mill-uġigħ fit-tfal ġie ristrett: dawn il-mediċini issa jintużaw biss fil-kura ta' uġigħ moderat (fuq perjodu qasir) akut fi tfal ta' aktar minn 12-il sena, u dan biss jekk ma jistax jinkiseb serħan b'analġesiċi oħra bħal paracetamol jew ibuprofen.
English: • Codeine is now only indicated in patients older than 12 years of age for the treatment of acute moderate pain that cannot be relieved by other analgesics such as paracetamol or ibuprofen (alone).
Maltese: • Il-kodeina issa hija indikata f'pazjenti ta' aktar minn 12-il sena għall-kura ta' uġigħ moderat akut li ma jistax jittaffa b'analġesiċi oħra bħal paracetamol jew ibuprofen (weħidhom).
English: In these patients, codeine is converted into morphine in the body at a faster rate than normal, resulting in high levels of morphine in the blood that can cause toxic effects such as respiratory depression.
Maltese: F'dawn il-pazjenti, il-kodeina tiġi kkonvertita f'morfina fil-ġisem b'rata aktar mgħaġġla min-normal, li dan iwassal għal livelli għoljin ta' morfina fid-demm li jista' jikkawża effetti tossiċi bħal dipressjoni respiratorja.