FrancophonIA/ELRC3.0 huggingface dataset:
English: The strengths are 0.5 mg, 1 mg and 2 mg. 0.5 mg tablets are white, 1 mg tablets are yellow and 2 mg tablets are peach-coloured.
Maltese: Issibhom f'qawwiet ta' 0.5 mg, 1 mg u 2 mg.
English: Do not take Prandin
Maltese: Tiħux Prandin:
English: Repaglinide closes ATP-dependent potassium channels in the β-cell membrane via a target protein different from other secretagogues.
Maltese: Repaglinide jagħlaq il-kanali tal-potassju dipendenti fuq l-ATP fil-membrana taċ-ċelloli β permezz ta' proteina partikolari li hija differenti minn prodotti oħra li jikkawżaw is-sekrezzjoni ta' l-insulina.
English: NAME OF THE MEDICINAL PRODUCT Prandin 1 mg tablets
Maltese: Prandin 1 mg pilloli
English: Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
Maltese: Ibla' l-pilloli ma' tazza ilma eżatt qabel jew sa 30 minuta qabel kull ikla prinċipali.
English: The recommended maximum single dose is 4 mg taken with main meals.
Maltese: Il-massimu ta' doża waħda rakkomandata hija 4 mg meħuda ma' ikliet prinċipali.
English: Repaglinide tablets are peach-coloured, round and convex and engraved with Novo Nordisk logo (Apis bull).
Maltese: Il-pilloli ta' repaglinide huma bojod, tondi u konvessi u inċiżi bil-logo Novo Nordisk (Apis bull).
English: • Danazol (used to treat breast cysts and endometriosis)
Maltese: • Danazol (użat għall-kura ta' ċisti fis-sider u l-endometrjożi)
English: Common (may affect up to 1 in 10 patients)
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 pazjenti)
English: • If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).
Maltese: - Jekk tieħu gemfibrozil (mediċina biex tnaqqas il-livelli għoljin ta' xaħam fid-demm).
English: Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.
Maltese: L-użu ta' repaglinide f'każ ta' falliment sekondarju għal sustanzi li jikkawżaw s-sekrezzjoni ta' l-insulina ma ġiex investigat fi studji kliniċi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of repaglinide.
Maltese: Kull pillola fiha 2 mg ta' repiglinide.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg of repaglinide.
Maltese: Kull pillola fiha: 0.5 mg ta' repaglinide
English: Combination with insulin secretagogues
Maltese: TWISSIJIET SPEĊJALI
English: • Have frequent hypos
Maltese: Frekwenza mhux magħrufa
English: Hypoglycaemic coma and hypoglycaemic unconsciousness
Maltese: Il-mod kif il-ġisem tiegħek jirrispondi għal Prandin jista' jinbidel jekk tieħu mediċini oħrajn, speċejalment dawn:
English: Not known
Maltese: Novo Alle'
English: Combination with metformin
Maltese: Polacrilin potassium
English: • Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers)
Maltese: • Mediċini antiinfjammatorji li m'humiex sterojdi (NSAIDS)
English: 08013-Barcelona Spain
Maltese: 08013-Barcelona Spanja
English: GROUNDS FOR NEGATIVE OPINION
Maltese: U RAĠUNIJIET GĦAL OPINJONI NEGATTIVA
English: D-83607 Holzkirchen Germany
Maltese: Raiffeisenstr. 11 D-83607 Holzkirchen Il-Ġermanja
English: A total of 30 post-dose adverse events were reported, with 6 adverse events probably related to the study treatment, 11 possibly related, 2 remotely related, and 11 unrelated.
Maltese: B'kollox ġew irrapportati 30 avveniment avvers ta' wara d-doża, b'6 avvenimenti avversi relatati probabbilment mat-trattament tal-istudju, 11 possibbilment relatati, 2 ftit li xejn relatati u 11 mhux relatati.
English: The following pharmacokinetic parameters were determined: AUC0-t, Cmax (primary) and AUC residual area, tmax, Ke;, t1/2 (secondary).
Maltese: Ġew iddeterminati il-parametri farmakokinetiċi li ġejjin: AUC0-t, Cmax (primarju) u żona residwa AUC , tmax, Ke;, t1/2 (sekondarja).
English: Lictyn 10 mg - Tabletten
Maltese: Lictyn 10 mg - Pillolaten
English: The calculated 90% CI for AUC0-t, AUCinf and Cmax for the metabolite descarboethoxyloratadine were within the 0.80- 1.25 acceptance range, but bioequivalence for loratadine tablets should also be based on parent compound data and because the 90% CI for Cmax and AUC of the parent compound were outside the standard 0.80 - 1.25 acceptance criterion, the objecting concerned member states considered that bioequivalence between Loratadine Sandoz 10 and the reference product could not be established.
Maltese: L-intervall ta' kunfidenza (CI) ikkalkulat ta' 90% għall-parametri AUC0-t, AUCinf u Cmax għall-metaboliat deskarboetossiloratadina (descarboethoxyloratadine) kienu fil-valuri aċċettabbli ta' 0.80 u 1.25, iżda lbijoekwivalenza għall-pilloli ta' loratadina għandha tkun ibbażata wkoll fuq dejta tal-kompost oriġinali (parent compound) u minħabba li s-CI ta' 90% għal Cmax u AUC tal-kompost oriġinali kienu barra millkriterju standard ta' aċċettazzjoni ta' 0.80 - 1.25, l-Istati Membri kkonċernati li oġġezzjonaw qiesu li lbijoekwivalenza bejn Loratadine Sandoz 10 u l-prodott ta' referenza ma setgħetx tiġi stabbilita.
English: Therefore, the products cannot be considered bioequivalent and the CHMP concluded that the benefit-risk of Loratadine Sandoz 10 is negative.
Maltese: Għaldaqstant, il-prodotti ma jistgħux jitqiesu bijoekwivalenti u s-CHMP kkonkluda li l-benefiċċju-riskju ta' Loratadine Sandoz 10 huwa negattiv.
English: The data showed that for loratadine, the 90% confidence interval for Cmax is outside the predefined acceptance range of 80-125% (although the 90% confidence intervals for AUC0-t, AUC0-∞ were respected).
Maltese: Id-dejta wriet li għal-loratadina, l-intervall ta' kunfidenza ta' 90% għal Cmax huwa barra l-valuri aċċettabbli prestabbiliti ta' 80-125% (għalkemm l-intervalli ta' kunfidenza ta' 90% għal AUC0-t, AUC0-∞ ġew rispettati).
English: The arguments used by the Applicant that the increase of about 5% in the intra-individual variability of Cmax in the second study (CV of 46.4%) justifies the post-hoc widening of the acceptance criteria cannot be accepted.
Maltese: Largumenti użati mill-Applikant li ż-żieda ta' madwar 5% fil-varjabbiltà bejn l-individwi ta' Cmax fit-tieni studju (CV ta' 46.4%) tiġġustifika t-twessigħ post hoc tal-kriterji aċċettabbli ma tistax tkun aċċettata.
English: Histamine is a major mediator of the allergic reaction.
Maltese: L-istamina hija medjatur importanti tar-reazzjoni allerġika.
English: the benefit-risk of the generic Loratadine Sandoz 10 is therefore considered to be negative,
Maltese: għaldaqstant, il-benefiċċju-riskju ta' Loratadine Sandoz 10 ġeneriku huwa meqjus negattiv,
English: GU35 9 QE
Maltese: SI-1000
English: The Applicant decided to perform a new BE study and submitted the full details of a single centre, randomised, single-dose, open-label, laboratory blinded 2-way crossover bioequivalence study comparing the rate and extent of absorption of Loratadine Sandoz 10 mg tablets versus the reference loratadine (Clarityne by ScheringPlough) under fasting conditions (Study SZ190/08).
Maltese: L-Applikant iddeċieda li jagħmel studju ġdid ta' bijoekwivalenza u ssottometta d-dettalji kollha ta' studju ta' bijoekwivalenza crossover monoċentriku, każwali, b'doża waħda, bit-tikketta mikxufa u mingħajr l-għarfien taż-żewġ naħat f'laboratorju li qabbel ir-rata u l-ammont ta' assorbiment tal-pilloli ta' 10 mg Loratadine Sandoz malloratadina ta' referenza (Clarityne ta' Schering-Plough) f'kundizzjonijiet ta' sawm (Studju SZ190/08).
English: The majority of adverse event were considered mild and the most commonly reported was headache (8.8% of subjects).
Maltese: Il-parti l-kbira tal-avvenimenti avversi tqiesu żgħar u l-aktar wieħed li ġie rrapportat kien l-uġigħ ta' ras (8.8% tas-suġġetti).
English: Loratadine and descarboethoxyloratadine concentrations in plasma were determined by s liquid chromatography assay with MS-MS detection.
Maltese: Ilkonċentrazzjonijiet tal-loratadina u d-deskarboetossiloratadina fil-plażma ġew stabbiliti permezz ta' analiżi ta' kromotografija likwida b'identifikazzjoni MS-MS.
English: Loratadine is an antagonist of histamine at H1 receptor sites (competitive, reversible) leading to the relief of allergic symptoms.
Maltese: Il-loratadina (loratadine) hija antagonist tal-istamina f'siti tar-riċetturi H1 (kompetittivi, reversibbli) li twassal għas-solljiev ta' sintomi allerġiċi.
English: In conclusion, the submitted study demonstrates the bioequivalence of Loratadine Sandoz 10mg tablets to the reference product for AUC0-t and AUC0-∞ of loratadine, but not for the Cmax parameter.
Maltese: B'konklużjoni għal dan, l-istudju ppreżentat juri lbijoekwivalenza tal-pilloli ta' 10 mg ta' Loratadine Sandoz mal-prodott ta' referenza għal AUC0-t u AUC0-∞ tal-loratadina, iżda mhux għall-parametru Cmax.
English: For parametric analysis, the 90% confidence interval was calculated.
Maltese: Għallanaliżi parametrika, ġie kkalkulat l-intervall ta' kunfidenza ta' 90%.
English: LORATADINE 10 MG TABLETS10 mg Tablet
Maltese: LORATADINE 10 mg TABLETS 10 mg Pillola
English: Regarding the basic statistical parameter analysis of AUC∞, AUCt and Cmax, both AUCs and Cmax values were subjected to analysis of variance (ANOVA), following the logarithmic transformation.
Maltese: Rigward l-analiżi tal-parametri statistiċi ta' bażi ta' AUC∞, AUCt u Cmax, iż-żewġ valuri AUCs u Cmax kienu soġġetti għall-analiżi ta' varjanza (ANOVA), skont il-bidla logaritmika.
English: The reason for this is that Cmax of a parent compound is usually more sensitive to detect differences between formulations in absorption rate than Cmax of a metabolite”.
Maltese: Ir-raġuni għal dan hija li Cmax ta' kompost oriġinali huwa normalment aktar sensittiv biex jiskopri differenzi bejn il-formulazzjonijiet firrata ta' assorbiment milli Cmax ta' metabolita”.
English: - bioequivalence between Loratadine Sandoz 10 and the reference product was not demonstrated for the parent compound,
Maltese: - il-bijoekwivalenza bejn Loratadine Sandoz 10 u l-prodott ta' referenza għall-kompost oriġinali ma ntweriex,
English: The sought indications for Loratadine Sandoz 10 were the relief of symptoms associated with seasonal and perennial allergic rhinitis and the treatment of the symptoms of chronic urticaria.
Maltese: L-indikazzjonijiet imfittxija għal Loratadine Sandoz 10 kienu s-solljiev minn sintomi assoċjati ma' rinite allerġika staġjonali u perenni u ttrattament tas-sintomi tal-urtikarja kronika.
English: This situation should have been foreseen and included in the study protocol and the CHMP therefore considers this to constitute a major objection.
Maltese: Din issitwazzjoni kellha tkun prevista u inkluża fil-protokoll ta' studju u s-CHMP għalhekk jikkunsidra li din hija oġġezzjoni importanti.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, APPLIKANTI / DETENTURI
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR NEGATIVE OPINION
Maltese: RAĠUNIJIET GĦAL OPINJONI NEGATTIVA
English: A post hoc justification for widening the acceptance range as was done for study SZ190/08 can therefore not be accepted.
Maltese: Għaldaqstant ġustifikazzjoni post hoc għat-twessigħ tal-valuri aċċettabbli kif sar għall-istudju SZ190/08 ma tistax tkun aċċettata.
English: Sandoz Pharmaceuticals GmbH
Maltese: Il-Ġermanja Sandoz Pharmaceuticals
English: Raiffeisenstr.
Maltese: L-Awstrija
English: United Kingdom Sandoz Limited Woolmer way
Maltese: Sandoz Limited Woolmer way Bordon, Hants, GU35 9 QE Ir-Renju Unit
English: The CHMP noted the presented data and stated that according to the current guideline (Questions & Answers on the Bioavailability and Bioequivalence Guideline CHMP/EWP/40326/06), bioequivalence should preferably be based on data for the parent drug, loratadine, as confirmed in the most recent draft guideline on bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1).
Maltese: Is-CHMP nnota d-dejta ppreżentata u ddikjara li skont il-linja gwida attwali (Mistoqsijiet u Tweġibiet dwar il-Linja gwida tal-Bijodisponibbiltà u tal-Bijoekwivalenza CHMP/EWP/40326/06), il-bijoekwivalenza preferibbilment għandha tkun ibbażata fuq dejta għall-mediċina oriġinali, il-loratadina, kif ikkonfermat flabbozz tal-linja gwida l-aktar reċenti dwar il-bijoekwivalenza (CPMP/EWP/QWP/1401/98 Rev. 1).
English: Loratadina SANDOZ 10 mg comprimate
Maltese: SANDOZ 10 mg comprimate
English: Verovskova 57 SI-1000 Ljubljana Slovenia
Maltese: Verovskova 57
English: The Applicant submitted an application for a repeat use procedure of Loratadine Sandoz 10 and associated names, 10 mg tablets on the basis of the marketing authorisation granted by The Netherlands on 12 July 2001.
Maltese: L-Applikant issottometta applikazzjoni għal proċedura ta' użu ripetut tal-pilloli ta' 10 mg ta' Loratadine Sandoz 10 u ismijiet assoċjati, fuq il-bażi tal-awtorizzazzjoni għattqegħid fis-suq mogħtija mill-Olanda fit-12 ta' Lulju 2001.
English: The Applicant, taking into account the lack of serious safety or efficacy concerns, therefore concluded that Loratadine Sandoz 10 can be considered to be efficacious and safe.
Maltese: L-Applikant, wara li qies innuqqas ta' tħassib serju dwar is-sigurtà jew l-effikaċja, għaldaqstant ikkonkluda li Loratadine Sandoz 10 jista' jitqies bħala effikaċi u sigur.
English: The Applicant emphasised that bioequivalence was shown for the metabolite, which is responsible for the main effect.
Maltese: L-Applikant enfasizza li ntweriet bijoekwivalenza tal-metabolita, li huwa responsabbli għall-effett ewlieni.
English: Loratadine is a potent, long acting antihistaminic which has a high selectivity for peripheral histamine H1-receptors and low affinity for H1-receptors in the central nervous system (CNS) in vitro or in vivo.
Maltese: H1 fissistema nervuża ċentrali(CNS) in vitro jew in vivo.
English: 80 subjects were enrolled in the study and randomly assigned to a treatment.
Maltese: Għallistudju ntgħażlu 80 persuna li każwalment ingħataw trattament.
English: In addition, Sandoz pharmacovigilance database indicates that there are no unaddressed safety or efficacy concerns for Loratadine Sandoz 10.
Maltese: Barra minn hekk, id-database tal-farmakoviġilanza ta' Sandoz tindika li m'hemmx tħassib ta' sigurtà jew ta' effikaċja li ma ġiex indirizzat għal Loratadine Sandoz 10.
English: Because major objections on bioequivalence remained unresolved, an Article 29(4) referral was triggered and the procedure was referred to the CHMP.
Maltese: Minħabba li oġġezzjonijiet kbar dwar ilbijoekwivalenza baqgħu ma ssolvewx, ingħata bidu għal referenza tal-Artikolu 29(4) u l-proċedura ġiet riferuta lis-CHMP.
English: Treatment with H1 - antagonists for the sought indication requires sufficient therapeutic drug levels for a period superior to 24 hours in order to provide relief from symptoms and the Applicant therefore argued that the therapeutic effect is best represented by the AUC of the unchanged loratadine and the metabolite rather than the peak concentration of parent compound alone.
Maltese: It-trattament bl-antagonisti tal-H1 għall-indikazzjoni mixtieqa teħtieġ livelli tal-mediċina terapewtiċi biżżejjed għal perjodu ta' aktar minn 24 siegħa sabiex tipprovdi solljiev mis-sintomi u għalhekk, l-Applikant argumenta li l-effett terapewtiku huwa rrappreżentat laħjar mill-AUC tal-loratadina invarjata u mill-metabolita aktar milli mill-konċentrazzjoni massima ta' kompost oriġinali waħdu.
English: The CHMP confirmed that the Guideline and the Q&A document (which were valid and available on the EMEA website at the time when the protocol for the bioequivalence study was finalized) state that a retrospective widening of the acceptance criteria for Cmax results is not allowed.
Maltese: Is-CHMP kkonferma li l-Linja gwida u d-dokument ta' Mistoqsijiet u Tweġibiet (li kienu validi u disponibbli fuq is-sit tal-EMEA fiż-żmien meta l-protokoll għall-istudju ta' bijoekwivalenza kien finalizzat) jiddikjaraw li mhuwiex permess twessigħ retrospettiv tal-kriterji aċċettabbli għal riżultati Cmax.
English: Loratadin Sandoz 10 mg tablety 10 mg Tablet
Maltese: Loratadin Sandoz 10 mg tablety 10 mg Pillola
English: The Applicant considered that due to the large intra-subject variability of loratadine, the use of a wider CI (0,75 - 1,33) was justified, and that differences in Cmax do not have a major clinical effect on the use of this product in humans.
Maltese: L-Applikant ikkunsidra li minħabba d-differenzi kbar ta' loratadina bejn is-suġġetti, l-użu ta' CI usa' (0,75 - 1,33) kien iġġustifikat, u li d-differenzi f'Cmax ma għandhomx effett kliniku kbir fuq l-użu ta' dan il-prodott fuq il-bnedmin.
English: In the clinical setting, loratadine has been used for over 10 years in the treatment of allergic disorders such as conjunctivitis, atopic dermatitis, urticaria, asthma, and anaphylaxis.
Maltese: Fil-kuntest kliniku, il-loratadina ntużat għal aktar minn għaxar snin fit-trattament ta' mard allerġiku bħal konġuntivite, dermatite atopika, urtikarja, ażma, u anafilassi.
English: The CHMP also noted the statement on GLP compliance in bio-analysis and considered that the analytical methods are acceptable and validated appropriately and seem adequate to accurately determine the concentration of loratadine and descarboethoxyloratadine in plasma.
Maltese: IsCHMP nnota wkoll id-dikjarazzjoni dwar il-konformità mal-GLP fil-bijoanaliżi u kkunsidra li l-metodi analitiċi huma aċċettabbli u konvalidati kif jixraq u jidhru adegwati sabiex tkun determinata b'mod eżatt ilkonċentrazzjoni ta' loratadina u deskarboetossiloratadina fil-plażma.
English: LORATADIN SANDOZ 10 MG 10 mg Tablet
Maltese: LORATADIN SANDOZ 10 mg 10 mg Pillola
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LORATADINE SANDOZ 10 AND ASSOCIATED NAMES (SEE ANNEX I)
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' LORATADINE SANDOZ 10 U ISMIJIET ASSOĊJATI (ARA L-ANNESS I)
English: Loratadine Sandoz 10 is used for the long term treatment of allergies and both parent compound and metabolite contribute to the clinical efficacy.
Maltese: Loratadine Sandoz 10 jintuża għat-trattament fit-tul ta' allerġiji u l-kompost oriġinali kif ukoll ilmetabolita jikkontribwixxu għall-effikaċja klinika.
English: Treatment phases were separated by a washout period of 21 days and subjects were administered a single oral dose as a 1 x 10 mg tablet and blood sampling was carried out prior to dosing (0) and at regular intervals post-dose.
Maltese: Bejn fażi tat-trattament u oħra kienu ġie osservat perjodu ta' sospensjoni (washout) ta' 21 jum u s-suġġetti ngħataw doża orali waħda f'forma ta' pillola 1 x 10 mg u ttieħed kampjun tad-demm qabel id-dożaġġ (0) u f'intervalli regolari wara d-doża.
English: The CHMP concluded that the bioequivalence between Loratadine Sandoz 10 and the reference product was not sufficiently demonstrated and adopted a List of Outstanding Issues, requesting the Applicant to further substantiate bioequivalence.
Maltese: Is-CHMP kkonkluda li lbijoekwivalenza bejn Loratadine Sandoz 10 u l-prodott ta' referenza ma ntwerietx biżżejjed u adotta Lista ta' Kwistjonijiet Pendenti, li jitolbu lill-Applikant sabiex jissostanzja aktar il-bijoekwivalenza.
English: Detailed explanations of the statistical calculations and the improved bio-analytical methods used were provided and in addition, the Applicant explained that the pharmacokinetics of loratadine increased its intra-individual variability.
Maltese: Ġew ipprovduti spjegazzjonijiet dettaljati tal-kalkoli statistiċi u tal-metodi bijoanalitiċi mtejba użati u barra minn hekk, l-Applikant spjega li l-proprjetajiet farmakokinetiċi tal-loratadina żiedu l-varjabbiltà tagħha bejn l-individwi.
English: ANNEX III CONDITIONS FOR THE LIFTING OF THE MARKETING AUTHORISATION SUSPENSIONS
Maltese: ANNESS III KUNDIZZJONIJIET GĦAT-TNEĦĦIJA TAS-SOSPENSJONIJIET TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: The metabolite can be used as a surrogate only if the Applicant presents convincing arguments demonstrating that it is not possible to reliably measure the parent compound after a single administration, which is not the case for loratadine.
Maltese: Il-metabolita jista' jintuża bħala sostitut biss jekk l-Applikant jippreżenta argumenti konvinċenti li juru li mhux possibbli li wieħed ikejjel b'mod affidabbli l-kompost oriġinali wara għotja unika, li mhux il-każ għal-loratadina.
English: - retrospective widening of the confidence interval is not accepted according to the current guidelines,
Maltese: - it-twessigħ retrospettiv tal-intervall ta' kunfidenza skont il-linji gwida eżistenti mhuwiex aċċettat,
English: Prevalence %
Maltese: Prevalenza %
English: African/Ethiopian African American
Maltese: Afrikana/Etjopjana Afrikana Amerikana
English: “Paediatric population:
Maltese: “Popolazzjoni pedjatrika:
English: Greek
Maltese: Griega
English: Section 4 - Possible side effects
Maltese: Sezzjoni 4 - Effetti sekondarji possibbli
English: “Reporting of side effects
Maltese: “Rappurtar tal-effetti sekondarji
English: “Children with compromised respiratory function
Maltese: “Tfal b'funzjoni respiratorja kompromessa
English: “CYP2D6 metabolism
Maltese: “Metaboliżmu ta' CYP2D6
English: “Reporting of suspected adverse reactions
Maltese: “Rappurtar ta' reazzjonijiet avversi suspettati
English: Estimates indicate that up to 7% of the Caucasian population may have this deficiency.
Maltese: Stimi jindikaw li sa 7% tal-popolazzjoni Kawkaża jista' jkollhom dan in-nuqqas.
English: Morphine is the substance that produces the effects of codeine.
Maltese: Morphine hija s-sustanza li tipproduċi l-effetti ta' codeine.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott tista' tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti tal-Istati Membri, flimkien mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri mniżżla taħt Kapitlu 4 ta' Titolu III ta' Direttiva 2001/83/KE.
English: Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite.
Maltese: Codeine huwa metabolizzat mill-enzima tal-fwied CYP2D6 f'morphine, il-metabolit attiv tiegħu.
English: “Codeine is transformed to morphine in the liver by an enzyme.
Maltese: “Codeine huwa trasformat għal morphine fil-fwied permezz ta' enzima.
English: Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
Maltese: Stimi ta' prevalenza ta' metabolizzaturi mgħaġġla ħafna f'popolazzjonijiet differenti huma miġbura filqosor taħt:
English: Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
Maltese: Codeine mhux rakkomandat għall-użu fi tfal li għandhom funzjoni respiratorja li tista' tkun kompromessa inklużi disturbi newromuskolari, kondizzjonijiet severi kardijaċi jew respiratorji, infezzjonijiet fl-apparat respiratorju ta' fuq jew fil-pulmun, trawma multipla jew proċeduri kirurġiċi estensivi.
English: • “In women during breastfeeding (see section 4.6)”
Maltese: • “F'nisa li qed ireddgħu (ara sezzjoni 4.6)”
English: General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite.
Maltese: Sintomi ġenerali ta' tossiċità tal-opojdi jinkludu konfużjoni, ngħas, nifs baxx, pupilli tal-għajnejn żgħar, dardir, rimettar, stitikezza u nuqqas ta' aptit.
English: Section 4.2 - Posology and method of administration [Note: For products authorised in the cough and/or cold indication only:]
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' kif għandu jingħata [Nota: Għall-prodotti awtorizzati fl-indikazzjoni ta' sogħla u/jew riħ biss:]
English: Morphine is the substance that produces the effects of codeine and relieves pain and symptoms of cough.
Maltese: Morphine hija s-sustanza li tipproduċi l-effetti ta' codeine u ttaffi l-uġigħ u s-sintomi ta' sogħla.