FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are: Sodium acetate trihydrate, acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections (see Section 2 “Plegridy contains Sodium”).
Maltese: Sodium acetate trihydrate, acetic acid, glacial, arginine hydrochloride, polysorbate 20 u ilma għall-injezzjonijiet (ara Sezzjoni 2 “Plegridy fih is-sodium”),.
English: After that you will be provided with a maintenance pack containing grey pens with Plegridy 125 micrograms (for day 28 and then every two weeks).
Maltese: Wara dak il-perjodu, inti se tingħata pakkett ta' manteniment li jkun fih pinen griżi bi Plegridy 125 mikrogramma (għal jum 28 u mbagħad kull ġimagħtejn).
English: At very high doses, anovulatory and abortifacient effects were observed in animals.
Maltese: F'dożi għoljin ħafna, effetti anovulatorji u abortifaċjenti ġew osservati fl-annimali.
English: Early clinical features include thrombocytopenia, new onset hypertension, fever, central nervous system symptoms (e.g. confusion, paresis) and impaired renal function.
Maltese: Karatteristiċi kliniċi bikrin jinkludu tromboċitopenija, bidu ta' pressjoni għolja, deni, disturbi fis-sistema nervuża (eż. konfużjoni, paresi) u indeboliment fil-funzjoni tal-kliewi.
English: You will be provided with an Initiation Pack containing your first 2 injections: one orange syringe with Plegridy 63 micrograms (for day 0) and one blue syringe with Plegridy 94 micrograms (for day 14).
Maltese: Inti se tingħata Pakkett tal-Bidu li jkun fih l-ewwel 2 injezzjonijiet tiegħek: siringa waħda oranġjo bi Plegridy 63 mikrogramma (għal jum 0) u siringa waħda blu bi Plegridy 94 mikrogramma (għal jum 14).
English: - If you have severe depression or think about committing suicide.
Maltese: - Jekk għandek depressjoni severa jew qed taħseb dwar li twettaq suwiċidju.
English: Upon repeated dosing with peginterferon beta-1a of sexually mature female monkeys, effects on menstrual cycle length and progesterone levels were observed.
Maltese: Meta ngħata dożaġġ ripetut b'peginterferon beta-1a lil xadini nisa sesswalment maturi, ġew osservati effetti fuq it-tul taċ-ċiklu tal mestrwazzjoni u l-livelli tal-progesterone.
English: Plegridy 125 micrograms every 4 weeks
Maltese: Plegridy 125 mikrogramma kull 4 ġimgħat
English: Repeated dose toxicology studies were limited to 5 weeks as exposure was greatly diminished from 3 weeks onwards, due to the formation of anti-drug antibodies by rhesus monkeys to human interferon beta-1a.
Maltese: Studji dwar it-tossikoloġija ta' dożi ripetuti kienu limitati għal 5 ġimgħat billi l-esponiment naqas bil-kbir minn 3 ġimgħat lil hemm, minħabba l-formazzjoni ta' antikorpi kontra l-mediċina minn xadini rhesus għal interferon uman beta-1a.
English: HR 95% CI P-value p=0.0069
Maltese: valur p p=0.0069
English: They may get worse while using Plegridy:
Maltese: Dawn jistgħu jmorru għall-agħar waqt li tkun qed tuża Plegridy:
English: Hepatic transaminase abnormalities
Maltese: Anormalitajiet fit-transaminases tal-fwied
English: Patients with RRMS, with at least 2 relapses within the prior 3 years, and 1 relapse in the prior year, with an EDSS score of ≤5.0
Maltese: Pazjenti b'RRMS, b'mill-inqas 2 rikaduti fl-aħħar 3 snin, u 1 rikaduta fis-sena ta' qabel, b'punteġġ EDSS ta' ≤5.
English: Lesion mean ratio (95% CI)
Maltese: (95% CI)
English: Hepatic function
Maltese: Artralġja
English: Package leaflet: Information for the user Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe peginterferon beta-1a
Maltese: Informazzjoni għall-utent Plegridy 63 mg mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Plegridy 94 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Plegridy 125 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest peginterferon beta-1a
English: Each pre-filled pen contains 125 micrograms of peginterferon beta-1a in 0.5 mL.
Maltese: Kull pinna mimlija għal-lest fiha 125 mikrogramma ta' peginterferon beta-1a f'0.5 mL.
English: Additional supplies which are not included in the pack (see Figure B):
Maltese: Provvisti addizzjonali li mhumiex inklużi fil-pakkett (ara Figura B):
English: In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase (AST), alanine aminotransaminase (ALT)), are recommended prior to initiation and at regular intervals following introduction of Plegridy therapy and then periodically thereafter in the absence of clinical symptoms.
Maltese: Flimkien ma' dawk it-testijiet tal-laboratorju normalment meħtieġa biex jimmonitorjaw pazjenti bi sklerożi multipla, l-għadd sħiħ taċ-ċelluli tad-demm, u l-għadd differenzjali taċ-ċelluli tad-demm bojod, l għadd tal-plejtlits, u kimiċi tad-demm, li jinkludu testijiet tal-funzjoni tal-kliewi (eż. aspartate aminotransferase (AST), alanine aminotransaminase (ALT)), huma rakkomandati qabel tinbeda terapija bi Plegridy u f'intervalli regolari wara l-introduzzjoni ta' terapija bi Plegridy, u mbagħad perjodikament wara dan fl-assenza ta' sintomi kliniċi.
English: HR 95% CI P-value p=0.0383
Maltese: valur p p=0.0383
English: Plegridy should be used carefully with medicines that are broken down in the body by a group of proteins called “cytochrome P450” (e.g. some medicines used for epilepsy or depression).
Maltese: Plegridy għandu jintuża b'kawtela ma' mediċini li jitkissru fil-ġisem minn grupp ta' proteini msejħa “ċitokrom P450” (eż. xi mediċini li jintużaw għal kura ta' epilessija jew depressjoni).
English: Everyone has their own set of MS symptoms.
Maltese: Kulħadd għandu s-sett tiegħu ta' sintomi ta' MS.
English: Hypersensitivity Anaphylaxis1
Maltese: Anafilassi1
English: • You should hold the pen over your injection site at 90o angle.
Maltese: • Għandek iżżomm il-pinna fuq is-sit talinjezzjoni f'angolu ta' 90° grad.
English: a. Check the injection status window.
Maltese: - Ikkuntattja tabib immedjatament.
English: No dosage adjustments are necessary in patients with renal impairment based on study data in mild, moderate, and severe renal impairment and end stage renal disease (see sections 4.4 and 5.2).
Maltese: Mhux meħtieġ l-ebda aġġustamenti fid-dożaġġ f'pazjenti b'indeboliment tal-kliewi, ibbażat fuq dejta minn studju dwar indeboliment ħafif, moderat, u sever tal-kliewi u mard tal-kliewi li jkun fl-aħħar stadju (ara sezzjonijiet 4.4 u 5.2).
English: • Let the Plegridy pre-filled syringe warm to room temperature for at least 30 minutes.
Maltese: • Ħalli s-siringa mimlija għal-lest ta' Plegridy tisħon sakemm tilħaq it-temperatura talkamra għal tal-anqas 30 minuta.
English: An open-label study in patients switching from interferon beta therapy to Plegridy evaluated the onset and duration of prophylactically treated flu-like symptoms.
Maltese: Studju open-label f'pazjenti li jaqilbu minn terapija b'interferon beta għal Plegridy, evalwa l-bidu u t-tul ta' sintomi bħal tal-influwenza kkurati b'mod profilattiku.
English: Injection site haematoma Injection site swelling Injection site oedema Injection site rash Injection site warmth Injection site discolouration Injection site necrosis
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Each pre-filled syringe contains 125 micrograms of peginterferon beta-1a in 0.5 mL.
Maltese: Kull siringa mimlija għal-lest fiha 125 mikrogramma ta' peginterferon beta-1a f'0.5 mL.
English: In the clinical study conducted, the development of antibodies against the PEG moiety of peginterferon beta-1a had no discernible impact on safety, or clinical efficacy (including annualised relapse rate, MRI lesions, and disability progression).
Maltese: Fl-istudju kliniku li twettaq, l-iżvilupp ta' antikorpi kontra l-PEG moiety ta' peginterferon beta-1a ma kellu l-ebda impatt li seta' jiġi osservat fuq is-sigurtà, jew l-effikaċja klinika (li tinkludi rrata ta' rikaduta annwalizzata, leżjonijiet MRI, u progressjoni tad-diżabilità).
English: 1 pre-filled syringe contains 63 micrograms of peginterferon beta-1a in 0.5 mL.
Maltese: Kull siringa mimlija għal-lest fiha 63 mikrogramma ta' peginterferon beta-1a f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: No data are available from clinical efficacy/safety studies directly comparing pegylated with non-pegylated interferon beta-1a, or from patients switching between non-pegylated and pegylated interferon.
Maltese: L-ebda dejta mhi disponibbli minn studji dwar l-effikaċja klinika/sigurtà li qabblu direttament pegylated ma' non-pegylated interferon beta-1a, jew minn pazjenti li qalbu bejn non-pegylated u pegylated interferon.
English: numbness in the face, arms or legs - Acute or chronic pain, bladder and bowel problems, sexual problems and problems with vision - Difficulty thinking and concentrating, depression.
Maltese: tmewwit fil-wiċċ, fid-dirgħajn jew fir-riġlejn - Uġigħ akut jew kroniku, problemi fil-bużżieqa tal-awrina u fl-imsaren, problemi sesswali u problemi fil-vista
English: • Alcohol wipe
Maltese: • Tajjara bl-alkoħol
English: In patients experiencing flu-like symptoms, the median time to onset was 10 hours (interquartile range, 7 to 16 hours) after injection, and the median duration was 17 hours (interquartile range, 12 to 22 hours).
Maltese: (medda interquartile, 7 sa 16-il siegħa) wara l-injezzjoni, u t-tul medjan kien ta' 17-il siegħa (medda interquartile, 12 sa 22 siegħa).
English: Time*
Maltese: Żmien*
English: - Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Maltese: (ara sezzjonijiet 4.4 u 4.8).
English: Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Maltese: Monitoraġġ perjodiku ta' sinjali jew sintomi bikrin, eż. edema, proteinurija u indeboliment fil-funzjoni tal-kliewi hu rakkomandat, speċjalment f'pazjenti f'riskju ogħla ta' mard tal-kliewi.
English: Common side effects
Maltese: Effetti sekondarji serji
English: One injection of Plegridy 125 micrograms every 14 days (every two weeks).
Maltese: Injezzjoni waħda ta' Plegridy 125 mikrogramma kull 14-il jum (kull ġimagħtejn).
English: Plegridy 125 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 125 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 125 mikrogramma ta' peginterferon beta-1a f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: 1 pre-filled syringe contains 94 micrograms of peginterferon beta-1a in 0.5 mL.
Maltese: Kull siringa mimlija għal-lest fiha 94 mikrogramma ta' peginterferon beta-1a f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: Elevations of serum hepatic transaminases combined with elevated bilirubin were observed in two patients who had pre-existing liver test abnormalities prior to receiving Plegridy in the clinical trials.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: HR: Hazard ratio
Maltese: Effetti sekondarji oħrajn
English: The total combined time out of refrigeration at a temperature up to 25°C, should not exceed 30 days.
Maltese: Il-ħin kombinat totali barra mir-refriġerazzjoni f'temperatura sa 25°C m'għandux jaqbeż it-30 jum.
English: Box of two 125 microgram pre-filled pens (grey labelled pens) in a protective plastic tray.
Maltese: Kaxxa ta' żewġ pinen mimlija għal-lest ta' 125 mikrogramma (pinen bit-tikketta griża) fi trej protettiv tal-plastik.
English: - Keep this leaflet.
Maltese: Proporzjon medju ta' leżjonijiet
English: 1 pre-filled pen contains 63 micrograms of peginterferon beta-1a in 0.5 mL.
Maltese: Kull pinna mimlija għal-lest fiha 63 mikrogramma ta' peginterferon beta-1a f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: Cessation of therapy with Plegridy should be considered (see section 4.8).
Maltese: Il-waqfien tat-terapija bi Plegridy għandu jiġi kkunsidrat (ara sezzjoni 4.8).
English: Contents of the pack and other information What Plegridy contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Plegridy
English: Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Maltese: Riżultati tal-laboratorju li jissuġġerixxu TMA jinkludu tnaqqis fl-għadd tal-plejtlits, żieda fil-livell ta' serum lactate dehydrogenase (LDH) minħabba l emolisi u xistoċiti (fragmentazzjoni ta' eritroċiti) fuq film tad-demm.
English: Table 1: Titration schedule at initiation Dose
Maltese: Pass 2: Iġbor il-provvisti tiegħek u aħsel idejk
English: 1 pre-filled pen contains 94 micrograms of peginterferon beta-1a in 0.5 mL.
Maltese: Kull pinna mimlija għal-lest fiha 94 mikrogramma ta' peginterferon beta-1a f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: Based on the known pharmacology of interferon beta-1a and clinical experience with interferon beta, the potential for carcinogenicity is expected to be low.
Maltese: Ibbażat fuq il-farmakoloġija magħrufa ta' interferon beta-1a u l-esperjenza klinika b'interferon beta, il-potenzjal għal karċinoġeneċità hu mistenni li jkun baxx.
English: The study design and patient demographics are presented in Table 2.
Maltese: Id-disinn tal-istudju u d-demografika tal-pazjenti huma ppreżentati f'Tabella 2.
English: Of the patients who reported flu-like symptoms 90% reported them as mild or moderate in severity.
Maltese: Mill-pazjenti li rrappurtaw sintomi bħal dawk tal-influwenza, 90% irrappurtawhom bħala ħfief jew moderati fis severità.
English: • If needed, Plegridy may be stored in the closed original carton without refrigeration up to 25°C for up to 30 days.
Maltese: • Jekk ikun meħtieġ, Plegridy jista' jinħażen fil-kartuna oriġinali magħluqa mingħajr refriġerazzjoni sa 25°C sa 30 jum.
English: Headache
Maltese: Griż
English: Disease history
Maltese: KLINIKU
English: Full dose injection: 125 micrograms, choose grey pen
Maltese: 125 mikrogramma, agħżel pinna griża
English: Prophylactic and concurrent use of anti-inflammatory, analgesic and/or antipyretic treatments may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sintomi jew sinjali ta' tnaqqis fl-għadd tad demm periferali (ara sezzjoni 4.8).
English: - Epilepsy or other seizure disorders, not controlled by medicine - Heart problems, which can cause symptoms such as chest pain (angina), particularly after any activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmia).
Maltese: - Epilessija jew disturbi oħrajn ta' aċċessjoni, li ma jkunux ikkontrollati bil-mediċina - Problemi f'qalbek, li jistgħu jikkawżaw sintomi bħal uġigħ fis-sider (anġina), partikularment wara kwalunkwe attività; għekiesi minfuħin, qtugħ ta' nifs (insuffiċjenza konġestiva tal-qalb); jew taħbit irregolari tal-qalb (arritmija).
English: Other medicines and Plegridy
Maltese: Mediċini oħra u Plegridy
English: The syringe inside the pen is a 1 mL pre-filled syringe made of glass (Type I) with a bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield, containing 0.5 mL of solution.
Maltese: Siringa mimlija għal-lest ta' 1 mL magħmula minn ħġieġ (Tip I) b'tapp tal-lastku tal-bromobutyl u protezzjoni termoplastika u tal-polypropylene riġida tal-labra, li jkun fiha 0.5 mL ta' soluzzjoni.
English: Plegridy 125 micrograms solution for injection in pre-filled syringe peginterferon beta-1a
Maltese: Plegridy 125 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest peginterferon beta-1a
English: Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe peginterferon beta-1a
Maltese: Plegridy 63 mg mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Plegridy 94 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest peginterferon beta-1a
English: Make sure you can see the green stripes in the injection status window (see Figure F).
Maltese: jew fuq in-naħa ta' wara tal-parti ta' fuq tad-driegħ tiegħek (ara ż-żoni mmarkati f'Figura D).
English: Read the instructions in section 7 “Instructions for injecting Plegridy pre-filled syringe” at the end of this leaflet before you start using Plegridy.
Maltese: Aqra l-istruzzjonijiet f'sezzjoni 7 “Istruzzjonijiet biex tinjetta il-pinna mimlija għal-lest ta' Plegridy” fit-tmiem ta' dan fuljett qabel ma tibda tuża Plegridy.
English: In the ATTAIN extension study, long-term efficacy with Plegridy was maintained with continuous treatment up to 4 years as shown by clinical and MRI measures of MS disease activity.
Maltese: Fl-istudju ta' estensjoni ATTAIN, l effikaċja fit-tul bi Plegridy inżammet b'kura kontinwa sa 4 snin kif muri minn kejl kliniku u permezz tal-MRI tal-attività tal-marda MS.
English: • Pull the needle straight out (See Figure K).
Maltese: • Iġbed il-labra dritt il- barra (Ara Figura K).
English: Efficacy of Plegridy has been demonstrated over placebo.
Maltese: L-effikaċja ta' Plegridy intweriet fuq il-plaċebo.
English: Plegridy 125 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 125 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection.
Maltese: Kull pinna mimlija għal-lest fiha 125 mikrogramma ta' peginterferon beta-1a f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: Limited information available on the transfer of interferon beta-1a into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1a excreted in human milk are negligible.
Maltese: informazzjoni disponibbli fuq l-effetti ta' interferon beta-1a fil-perjodi ta' qabel, matul u wara t-twelid hi limitata.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Maltese: 3660 8427 Email: press@ema.europa.eu
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 April 2015 EMA/249413/2015
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom sogħla u rjiħat fit-tfal, inbeda t-tieni rieżami madwar l-UE kollha ta' tali użu.
English: The review of codeine when used for cough and cold in children was initiated in April 2014 at the request of the German medicines agency (BfArM), under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami tal-kodeina meta tintuża għas-sogħla u għall-irjiħat fit-tfal inbdiet f'April 2014 fuq talba talaġenzija Ġermaniża għall-mediċini (BfArM), skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: The CMDh is a body representing EU Member States as well as Iceland, Lichtenstein and Norway, and is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Is-CMDh huwa korp li jirrappreżenta lill-Istati Membri tal-UE kif ukoll lill-Iżlanda, lil-Liechtenstein u lin-Norveġja, u huwa responsabbli biex jiġu żgurati standards armonizzati ta' sigurtà għall-mediċini awtorizzati permezz ta' proċeduri nazzjonali fl-UE kollha.
English: • Codeine is also contraindicated in women during breastfeeding and patients known to be CYP2D6
Maltese: • Il-kodeina hija wkoll kontraindikata f'nisa waqt it-treddigħ u f'pazjenti magħrufin li huma metabolizzaturi ultra-rapidi ta' CYP2D6.
English: Codeine is an opioid medicine that is converted into morphine in the body.
Maltese: Il-kodeina hija mediċina opjojde li tiġi konvertita f'morfina fil-ġisem.
English: The available data indicate that the way codeine is converted into morphine in children below 12 years is more variable and unpredictable, making this population at special risk of morphine-induced side effects.
Maltese: Id-data disponibbli tindika li l-mod kif il-kodeina tiġi konvertita f'morfina fit-tfal taħt it-12-il sena huwa aktar varjabbli u imprevedibbli, u dan ipoġġi lil din il-popolazzjoni f'riskju speċjali ta' effetti sekondarji kkawżati mill-morfina.
English: In addition, the evidence that codeine is effective at treating cough in children is limited and international guidelines emphasise that cough associated with viral infections may be satisfactorily managed with fluids and increased ambient humidity; in the case of chronic cough, treatment should be directed at the underlying disease.
Maltese: Barra minn hekk, l-evidenza li l-kodeina hija effettiva fil-kura tas-sogħla fit-tfal hija limitata u linji gwida internazzjonali jenfasizzaw li s-sogħla assoċjata ma' infezzjonijiet virali tista' tiġi maniġġjata b'mod sodisfaċenti bil-fluwidi u b'żieda fl-umdità ambjentali; fil-każ ta' sogħla kronika, il-kura għandha tkun diretta lejn il-marda sottostanti.
English: High levels of morphine can lead to serious effects, such as breathing difficulties.
Maltese: Livelli għoljin ta' morfina jistgħu jwasslu għal effetti serji, bħal diffikultajiet fit-teħid tan-nifs.
English: Codeine is marketed as a single-ingredient medicine or in combination with other active substances.
Maltese: Il-kodeina hija kkummerċjalizzata bħala mediċina b'sustanza unika jew f'kombinazzjoni ma' sustanzi attivi oħra.
English: In total, 14 cases of codeine intoxication in children (aged from 17 days to 6 years) related to the treatment of cough and respiratory infection were identified in the published literature, four of which had a fatal outcome.
Maltese: B'kollox, fil-letteratura ppubblikata ġew identifikati 14-il każ ta' intossikazzjoni bil-kodeina fit-tfal (b'età minn 17-il jum sa 6 snin) relatata mal-kura ta' sogħla u ta' infezzjoni respiratorja, li erbgħa minnhom kellhom riżultat fatali.
English: Some people convert codeine to morphine at a faster rate than normal, resulting in high levels of morphine in their blood.
Maltese: Xi persuni jikkonvertu lkodeina f'morfina b'rata aktar mgħaġġla min-normal, u dan iwassal għal livelli għoljin ta' morfina fiddemm tagħhom.
English: These new measures follow a review of available safety and efficacy data on codeine when used for cough and cold, including data from clinical studies, observational studies and meta-analyses, postmarketing data in Europe and other published literature on the use of codeine in children.
Maltese: Dawn il-miżuri ġodda ġejjin wara rieżami tad-data disponibbli dwar is-sigurtà u l-effikaċja dwar ilkodeina meta tintuża għas-sogħla u għall-irjiħat, inkluża data minn studji kliniċi, studji ta' osservazzjoni u meta-analiżi, data wara t-tqegħid fis-suq fl-Ewropa u letteratura oħra ppubblikata dwar l-użu talkodeina fit-tfal.
English: On 22 April 2015 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Maltese: Fit-22 ta' April 2015 is-CMDh adotta l-pożizzjoni tiegħu b'kunsens, sabiex il-miżuri rakkomandati millPRAC jiġu implimentati direttament mill-Istati Membri fejn il-mediċini huma awtorizzati, skont skeda ta' żmien miftiehma.
English: In addition, children who already have problems with their breathing may be more susceptible to respiratory problems due to codeine.
Maltese: Barra minn hekk, tfal li diġà għandhom problemi tan-nifs jistgħu jkunu aktar suxxettibbli għal problemi respiratorji minħabba l-kodeina.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), EMA's Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations.
Maltese: Ir-rieżami sar mill-Kumitat għall-Evalwazzjoni tar-Riskji fil-Qasam tal-Farmakoviġilanza (PRAC), ilKumitat tal-EMA responsabbli għall-evalwazzjoni ta' kwistjonijiet ta' sigurtà għall-mediċini li jintużaw mill-bniedem, li għamel sett ta' rakkomandazzjonijiet.