FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies, paediatric patients 3 months to less than 18 years of age had a mean duration of treatment with atazanavir of 115 weeks.
Maltese: Fi studji kliniċi, pazjenti pedjatriċi minn 3 xhur sa mhux aktar minn 18-il sena kienu kkurati b'atazanavir għal żmien medju ta' 115-il ġimgħa.
English: Co-administration of EVOTAZ and cisapride is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' EVOTAZ u cisapride huwa kontraindikat (ara sezzjoni 4.3).
English: Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with EVOTAZ may result in increased concentrations.
Maltese: Simvastatin u lovastatin jiddependu ħafna fuq CYP3A4 għall-metaboliżmu tagħhom u lgħoti flimkien tagħhom ma' EVOTAZ jista' jirriżulta f'konċentrazzjonijiet miżjuda.
English: Each single agent produced effects on left ventricular contractility and PR prolongation at concentrations at least 35-fold higher than the free atazanavir and cobicistat concentrations at the recommended human dose (RHD) Cmax.
Maltese: Kull sustanza waħdiena pproduċiet effetti fuq il-kontrattilità ventrikulari tax-xellug u titwil ta' PR f'konċentrazzjonijiet tal-anqas 35 darba ogħla millkonċentrazzjonijiet ħielsa ta' atazanavir u cobicistat fis-Cmax tad-doża rakkomandata fil-bniedem (RHD).
English: For the treatment of erectile dysfunction, it is recommended that when co-administered with EVOTAZ, sildenafil should be used with caution at reduced doses of 25 mg every 48 hours; tadalafil should be used with caution at reduced doses of 10 mg every 72 hours; vardenafil should be used with caution at reduced doses of no more than 2.5 mg every 72 hours.
Maltese: Għall-kura ta' disfunzjoni erettili, huwa rrakkomandat li meta sildenafil jingħata flimkien ma' EVOTAZ, dan jintuża b'attenzjoni f'dożi mnaqqsa ta' 25 mg kull 48 siegħa; tadalafil għandu jintuża b'attenzjoni f'dożi mnaqqsa ta' 10 mg kull 72 siegħa; vardenafil għandu jintuża b'attenzjoni f'dożi mnaqqsa ta' mhux aktar minn 2.5 mg kull 72 siegħa.
English: Co-administration of EVOTAZ and elbasvir/grazoprevir is contraindicated because of the expected increase in grazoprevir plasma concentrations and the associated potential increase in the risk of ALT elevations (see section 4.3).
Maltese: L-għoti flimkien ta' EVOTAZ u elbasvir/grazoprevir huwa kontraindikat minħabba ż-żieda mistennija fil-konċentrazzjonijiet fil-plażma ta' grazoprevir u ż-żieda potenzjali assoċjata fir-riskju ta' żieda fl-ALT (ara sezzjoni 4.3).
English: The full EPAR for Anagrelide Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After a week, the dose is increased every week by 0.5 mg a day, until the platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the level usually seen in healthy people).
Maltese: Wara ġimgħa, id-doża tiżdied b'0.5 mg kuljum, sakemm l-għadd ta' pjastrini jkun inqas minn 600 miljun pjastrina għal kull millilitru, u idealment bejn 150 u 400 miljun/ml (il-livell li normalment jiġi osservat f'persuni b'saħħithom).
English: Anagrelide Mylan is available as capsules (0.5 and 1 mg).
Maltese: Anagrelide Mylan jiġi bħala kapsuli (0.5 u 1 mg).
English: Anagrelide Mylan contains the active substance anagrelide and is a ‘generic medicine'.
Maltese: Anagrelide Mylan fih is-sustanza attiva anagrelid u huwa "mediċina ġenerika".
English: Other information about Anagrelide Mylan
Maltese: Informazzjoni oħra dwar Anagrelide Mylan
English: The maximum recommended dose of Anagrelide Mylan is 2.5 mg at a time.
Maltese: Id-doża massima rakkomandata ta' Anagrelide Mylan hija 2.5 mg kull darba.
English: This is a summary of the European public assessment report (EPAR) for Anagrelide Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Anagrelide Mylan.
English: What are the benefits and risks of Anagrelide Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Anagrelide Mylan?
English: Why is Anagrelide Mylan approved?
Maltese: Għaliex ġie approvat Anagrelide Mylan?
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Xagrid, and do not need to be repeated for Anagrelide Mylan.
Maltese: Diġà saru l-istudji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Xagrid, u m'hemmx għalfejn jiġu ripetuti għal Anagrelide Mylan.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku anagrelid
English: The recommended starting dose is one 0.5 mg capsule twice a day.
Maltese: Id-doża inizjali rakkomandata hija kapsula waħda 0.5 mg darbtejn kuljum.
English: The active substance in Anagrelide Mylan, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes', which produce platelets.
Maltese: Is-sustanza attiva f'Anagrelide Mylan, l-anagrelid, timblokka l-iżvilupp u t-tkabbir ta' ċelloli fil-mudullun li jissejħu ‘megakarjoċiti', li jipproduċu l-pjastrini.
English: Anagrelide Mylan is also a ‘hybrid medicine' because it is available in an additional strength.
Maltese: Anagrelide Mylan hu wkoll ‘mediċina ibrida' għaliex jiġi f'qawwa addizzjonali.
English: Because Anagrelide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Anagrelide Mylan huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The Agency recommended that Anagrelide Mylan be approved for use in the EU.
Maltese: L-Aġenzija rrakkomandat li Anagrelide Mylan ikun approvat għall-użu fl-UE.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Ilkumpanija wettqet ukoll studju li wera li hija ‘bijoekwivalenti' għall-mediċina ta' referenza.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Anagrelide Mylan has been shown to have comparable quality and to be bioequivalent to Xagrid.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Anagrelide Mylan wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Xagrid.
English: How has Anagrelide Mylan been studied?
Maltese: Kif ġie studjat Anagrelide Mylan?
English: Anagrelide Mylan is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets circulating in the blood).
Maltese: Anagrelide Mylan huwa mediċina li tintuża biex tnaqqas l-għadd ta' pjastrini (komponenti li jgħinu fittagħqid tad-demm) f'pazjenti li jbatu minn tromboċitemija essenzjali (marda fejn ikunu qegħdin jiċċirkolaw wisq pjastrini fid-demm). ‘Essenzjali' tfisser li l-marda m'għandha l-ebda kawża ovvja.
English: As for every medicine, the company provided studies on the quality of Anagrelide Mylan.
Maltese: Bħal kull mediċina oħra, il-kumpanija pprovdiet studji dwar il-kwalità ta' Anagrelide Mylan.
English: Anagrelide Mylan is used when the patient's current treatment does not work well enough or has unacceptable side effects, and when they are ‘at risk' because of their age (over 60 years), very high platelet counts or previous clotting problems.
Maltese: Anagrelide Mylan jintuża meta l-kura attwali tal-pazjenti ma taħdimx tajjeb biżżejjed jew ikollha effetti sekondarji mhux aċċettabbli, u meta l-pazjenti jkunu ‘f'riskju' minħabba l-età tagħhom (iktar minn 60 sena), meta jkollhom għadd kbir ħafna ta' pjastrini jew ikun diġà kellhom problemi ta' tagħqid taddemm.
English: This means that Anagrelide Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Xagrid.
Maltese: Dan ifisser li Anagrelide Mylan fih l-istess sustanza attiva u jaħdem bl-istess mod bħall-'mediċina ta' referenza' li hija diġà awtorizzata fl-Unjoni Ewropea (EU) bl-isem ta' Xagrid.
English: How is Anagrelide Mylan used?
Maltese: Kif jaħdem Anagrelide Mylan?
English: United Kingdom Genus Pharmaceuticals Holdings Limited, Park View House, 65
Maltese: Ir-Renju Unit Genus Pharmaceuticals Holdings Limited, Park View House, 65
English: United Kingdom Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, CY-1060
Maltese: Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, CY-1060
English: 2 g of meprobamate (in combination with magnesium oxide, magnesium sulphate, kaolin, sterculia gum)
Maltese: 2 g ta' meprobamat (f'kombinazzjoni ma' ossidu tal-manjesju, sulfat tal-manjesju, kaolina, sterculia gum)
English: 1106 Budapest Hungary
Maltese: Keresztúri út 30-38. 1106 Budapest Hungary
English: 200 mg of meprobamate (in combination with medroxyprogesterone acetate bendroflumethiazide)
Maltese: 200 mg ta' meprobamat (f'kombinazzjoni ma' medroxyprogesterone acetate bendroflumethiazide)
English: Recip AB, Box 906, SE-170 09 Solna Sweden
Maltese: In-Norveġja Recip AB, Box 906, SE-170 09 Solna
English: Sweden
Maltese: Finland
English: 150 mg of meprobamate (in combination with quinine)
Maltese: 150 mg ta' meprobamat (f'kombinazzjoni ma' kinina)
English: 400 mg of meprobamate (in combination with aceprometazine)
Maltese: 400 mg ta' meprobamat (f'kombinazzjoni ma' aceprometazine)
English: Annex I List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Maltese: Anness I Lista tal-ismijiet ivvintati, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħataw, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: Clinical/safety
Maltese: Sigurtà/klinika
English: 31 March
Maltese: 31 ta' Marzu 2015:
English: 2015:pilot study 31 December 2016: main cohort (1 year results)
Maltese: studju pilota 31 ta' Diċembru 2016: koorti ewlieni (riżultati ta' sena)
English: The MAH will perform a PASS study to address all important, potential and identified risks, particularly Parkinsonism.
Maltese: L-MAH għandu jagħmel studju PASS sabiex jindirizza r-riskji kollha importanti, potenzjali u identifikati, b'mod partikolari l-Parkinsoniżmu.
English: The full study protocol for the nested case-control study within the European Society of Cardiology cohort, to investigate the potential association between extrapyramidal symptoms (EPS) and trimetazidine will be submitted to the MSs/RMS within 60 days after Commission Decision to be finalised prior to starting the study.
Maltese: Ilprotokoll sħiħ tal-istudju ta' kontroll ta' każijiet miġbura fi ħdan il-koorti talGħaqda Ewropea tal-Kardjoloġija għall-investigazzjoni tal-assoċjazzjoni potenzjali bejn is-sintomi ekstrapiramidali (EPS) u trimetazidine għandu jiġi ppreżentat lill-SM/RMS fi żmien 60 jum mid-Deċiżjoni tal-Kummissjoni li għandu jiġi ffinalizzat qabel ma jibda l-istudju.
English: The MAH should perform a PK study assessing the effect of renal impairment and age on trimetazidine pharmacokinetics according to the CHMP agreed protocol.
Maltese: L-MAH għandu jagħmel studju tal-PK li fih jevalwa l-effett tal-indeboliment renali u l-età fuq il-farmakokinetika ta' trimetazidine skont il-protokoll maqbul mis-CHMP.
English: National Competent Authorities (NCAs) of Member State(s) or Reference Member State(s) (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti (NCAs) tal-Istat(i) Membru/i jew l-Istat(i) Membru/i ta' Referenza (RMS), fejn ikun applikabbli, għandhom jiżguraw li l-MAH(s) jissodisfa(w) dawn ilkundizzjonijiet:
English: DHPC Communication circulation according to the CHMP agreed action plan and conditions.
Maltese: Tintbagħat Komunikazzjoni DHPC skont il-pjan ta' azzjoni miftiehem u lkundizzjonijiet tas-CHMP.
English: The final study report will be submitted to NCAs/RMS by:
Maltese: Irrapport finali tal-istudju għandu jkun ippreżentat lill-NCAs/RMS sa:
English: The final study results will be submitted to NCAs/RMS by:
Maltese: Ir-riżultati finali tal-istudju għandhom ikunu ppreżentati lill-NCAs/RMS sa:
English: The final study report will be submitted to MSs/RMS by:
Maltese: Ir-rapport finali tal-istudju ser jiġi ippreżentat lill-SM/RMS sa:
English: Conditions to the marketing authorisations
Maltese: Effetti sekondarji possibbli
English: MedDRA- system organ class database
Maltese: Sistema tal-klassifika tal-organi fid-database MedDRA
English: Propylene glycol Titanium dioxide (E171) Iron oxide black (E172) Iron oxide yellow (E172)
Maltese: Titanium dioxide (E171) Iron oxide black (E172) Iron oxide yellow (E172)
English: Adults (including the elderly)
Maltese: Adulti (inklużi l-anzjani)
English: Trientine is acetylated in two major metabolites, N(1)-acetyltriethylenetetramine (MAT) and N(1),N(10)-diacetyltriethylenetetramine (DAT).
Maltese: Trientine hu aċetilat f'żewġ metaboliti ewlenin, N(1)-acetyltriethylenetetramine (MAT) u N(1),N(10)-diacetyltriethylenetetramine (DAT).
English: Uncommon: Rash
Maltese: Mhux komuni: Raxx
English: Store in a refrigerator (2ºC-8ºC).
Maltese: Aħżen fi friġġ (2ºC-8ºC).
English: CARTON/BOTTLE
Maltese: KARTUNA/FLIXKUN
English: Univar Solutions BV Schouwburgplein 30 3012 CL Rotterdam The Netherlands
Maltese: Univar Solutions BV Schouwburgplein 30
English: EU/1/19/1365/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1365/001
English: Capsule content:
Maltese: Kontenut tal-kapsuli:
English: 100 capsules
Maltese: Kapsula iebsa. 100 kapsula
English: Q4 2022 PK/PD substudy
Maltese: substudju PK/PD
English: In cases up to 20 g of trientine base there were no apparent adverse effects reported.
Maltese: F'każijiet sa 20 g ta 'bażi ta' trientine ma kien hemm l-ebda effetti avversi apparenti rrappurtati.
English: - The active substance is trientine.
Maltese: X'fih Cufence - Is-sustanza attiva hi trientine.
English: The recommended dose is 800-1,600 mg (4-8 capsules) daily in 2 to 4 divided doses.
Maltese: Id-doża rakkomandata hi ta' 800 - 1,600 mg (4-8 kapsuli) kuljum f'2 sa 4 dożi maqsumin.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism, various alimentary tract and metabolism products, ATC code: A16AX12
Maltese: Prodotti oħra tal-passaġġ alimentari u tal-metaboliżmu, diversi prodotti tal-apparat alimentari u tal-metaboliżmu, kodiċi ATC:
English: Final report: Q4 2025 (main study)
Maltese: Q4 2025 (studju ewlieni) Q4 2022
English: Aesica Pharmaceuticals GmbH Alfred Nobel Strasse 10 Monheim 40789
Maltese: Aesica Pharmaceuticals GmbH Alfred Nobel Strasse 10
English: < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħrufa (ma tistax tiġi stmata mid-data disponibbli).
English: Each capsule contains 300 mg trientine dihydrochloride, equivalent to 200 mg trientine.
Maltese: Kull kapsula fiha 300 mg trientine dihydrochloride, ekwivalenti għal 200 mg trientine.
English: Other products
Maltese: Prodotti oħra
English: Magnesium stearate
Maltese: Kontenut tal-kapsuli: Magnesium stearate
English: Some positive in vitro mutagenicity data were obtained but in vivo test systems showed no mutagenic activity.
Maltese: Inkisbet xi dejta pożittiva in vitro dwar ilmutaġeniċità, iżda s-sistemi tat-test in vivo ma wrew ebda attività mutaġenika.
English: Each hard capsule contains 300 mg trientine dihydrochloride equivalent to 200 mg trientine.
Maltese: Kull kapsula iebsa fiha 300 mg trientine dihydrochloride ekwivalenti għal 200 mg trientine.
English: Trientine is absorbed with tmax occurring between 0.5 and 4 hours post-dose in healthy volunteers and patients.
Maltese: Trientine jiġi assorbit bit-tmax li sseħħ bejn 0.5 u 4 sigħat wara d-doża f'voluntiera b'saħħithom u f'pazjenti.
English: Date of first authorisation: 25 July 2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 ta 'Lulju 2019
English: Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Germany
Maltese: Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10
English: Chronic overtreatment can lead to copper deficiency and reversible sideroblastic anaemia.
Maltese: Trattament eċċessiv kroniku jista 'jwassal għal defiċjenza ta' ram u anemija sideroblastika riversibbli.
English: PAES: In order to further characterise the efficacy of trientine dihydrochloride in the treatment of Wilson's disease in patients with predominantly hepatic,
Maltese: Sabiex jikkaratterizza aktar l-effikaċja ta' trientine dihydrochloride filkura tal-marda ta' Wilson f'pazjenti b'sintomi predominantament epatiċi,
English: There is no antidote.
Maltese: M'hemm l-ebda antidotu.
English: Elimination Trientine and its metabolites are rapidly excreted in the urine.
Maltese: Trientine u l-metaboliti tirgħu jiġu eskretati rapidament fl-awrina.
English: Cufence 200 mg hard capsules
Maltese: Cufence 200 mg kapsuli ibsin
English: Cufence 200 mg hard capsules trientine
Maltese: Cufence 200 mg kapsuli ibsin trientine
English: There is limited information in patients with hepatic impairment.
Maltese: L-informazzjoni hi limitata f'pazjenti b'indeboliment epatiku.
English: Factors to consider include the known risks associated with untreated or undertreated Wilson's disease, risks associated with the stage of disease, the risk of those alternative treatments which are available and the possible effects of trientine (see section 5.3).
Maltese: Il-fatturi li għandhom jiġu kkunsidrati jinkludu r-riskji magħrufa assoċjati mal-marda ta' Wilson mhux trattata jew mhux trattata biżżejjed, irriskji assoċjati mal-istadju tal-marda, ir-riskju ta' dawk it-trattamenti alternattivi li huma disponibbli u l-effetti possibbli ta' trientine (ara sezzjoni 5.3).
English: Trientine dihydrochloride is a known irritant, especially to mucus membranes, upper respiratory tract and skin, and induces skin sensitisation in guinea pigs, mice and man (OECD SIDS triethylenetetramine 2002).
Maltese: Trientine dihydrochloride hu irritant magħruf, speċjalment għall-membrani mukużi, għall-apparat respiratorju superjuri u għall-ġilda, u jinduċi sensitizzazzjoni tal-ġilda fi fniek tal-Indi, fil-ġrieden u fil-bniedem (SIDS tal-2002 tal-OECD dwar it-trietilenetetrammina).
English: Fertility It is unknown whether trientine has an effect on human fertility.
Maltese: Mhuwiex magħruf jekk it-trientine għandhiex effett fuq il-fertilità umana.
English: Uncommon: Anaemia Uncommon: Aplastic anaemia Uncommon: Sideroblastic anaemia
Maltese: Mhux komuni: Anemija Mhux komuni: Anemija aplastika
English: Trientine has been found to reduce serum iron levels.
Maltese: Instab li trientine inaqqas il-livelli ta' ħadid tas-serum.
English: If you have any of the following side effects contact your doctor immediately: - Severe stomach pains - Persistent diarrhoea - Nervous system problems (for example shaking, lack of coordination, slurred speech, muscle stiffness, worsening of muscle spasms).
Maltese: - Dijarea persistenti - Problemi fis-sistema nervuża (pereżempju rogħda, nuqqas ta' koordinazzjoni, tlissin imħawwad,
English: For specific precautions see section 4.4.
Maltese: Għal prekawzjonijiet speċifiċi ara sezzjoni 4.4.
English: At the start of treatment the dose varies between 2 and 5 capsules per day.
Maltese: Fil-bidu tat-trattament, id-doża tvarja bejn 2 u 5 kapsuli kull jum.
English: The recommended doses of Cufence are expressed as mg of trientine base (i.e. not in mg of the trientine dihydrochloride salt) (see section 4.4).
Maltese: Id-dożi rakkomandati ta' Cufence huma espressi bħala mg tal-bażi ta' trientine (jiġifieri mhux f'mg talmelħ ta' trientine dihydrochloride) (ara sezzjoni 4.4).
English: There have been reports of neurological deterioration at the start of treatment in Wilson's disease patients treated with copper chelators including trientine, with symptoms of, for example, dystonia, rigidity, tremor and dysarthria (see section 4.2).
Maltese: Kien hemm rapporti ta' deterjorament newroloġiku fil-bidu tat-trattament f'pazjenti bil-marda ta' Wilson trattati b'kelaturi tar-ram li jinkludu trientine, b'sintomi ta', pereżempju, distonija, ebusija, rogħda u disartrija (ara sezzjoni 4.2).
English: No interaction studies have been performed on the concomitant administration of trientine with DPenicillamine.
Maltese: Ma sar ebda studju ta' interazzjoni fuq l-amministrazzjoni konkomitanti ta' trientine u DPeniċillammina.
English: Use in children and adolescents (5 to 17 years)
Maltese: Użu fit-tfal u fl-adolexxenti (5 sa 17-il sena)
English: Dose adjustment may be required (see section 4.2).
Maltese: Jista' jkun hemm bżonn li tiġi aġġustata d-doża (ara sezzjoni 4.2).
English: White, oval-shaped size 0 capsule printed with ‘Cufence 200' in grey ink.
Maltese: Kapsula bajda, ta' forma ovali u ta' daqs 0 bil-kliem “Cufence 200” stampat fuqha b'linka griża.
English: Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classification (SOC and
Maltese: It-tabella ppreżentata hawn taħt hi skont is-sistema tal-klassifika tal-organi f'MedDRA (SOC u Livell ta' Terminu Preferut).
English: Clinical trials with Cufence including a limited number of children in the age range of 5 to 17 years at the start of treatment indicate that frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Maltese: Provi kliniċi b'Cufence li jinkludu numru limitat ta' tfal fil-medda ta' etajiet ta' 5 sa 17-il sena fil-bidu tat-trattament jindikaw li l-frekwenza, it-tip u s-severità ta' reazzjonijiet avversi fit-tfal huma mistennija jkunu l-istess bħal fl-adulti.
English: The determination of serum free copper, calculated using the difference between the total copper and the ceruloplasmin-bound copper (normal level of free copper in the serum is usually 100 to 150 microgram/L), can be a useful index for monitoring therapy.
Maltese: Id-determinazzjoni ta' ram ħieles mis-serum, li jiġi kkalkulat permezz tad-differenza bejn ir-ram totali u r-ram marbut maċ-ċeruloplażmina (il-livell normali ta' ram ħieles fis-serum normalment huwa 100 sa 150 mikrogramma/L), tista' tkun indiċi utli għall-monitoraġġ tat-terapija.
English: The main toxicological findings associated with trientine, which were generally seen across all species examined, included body weight loss or lower body weight gain, altered urinary electrolytes, low plasma copper levels and various histopathological changes in the lungs (mainly interstitial pneumonitis).
Maltese: Is-sejbiet tossikoloġiċi ewlenin assoċjati ma' trientine, li ġeneralment dehru fl-ispeċijiet eżaminati kollha, kienu jinkludu telf tal-piż tal-ġisem jew żieda mnaqqsa fil-piż tal-ġisem, elettroliti urinarji alterati, livelli baxxi ta' ram fil-plażma u diversi tibdiliet istopatoloġiċi fil-fwied (primarjament pulmonite interstizjali).
English: Cufence is indicated for the treatment of Wilson's disease in patients intolerant to D-Penicillamine therapy, in adults, adolescents and children aged 5 years or older.
Maltese: Cufence hu indikat għat-trattament tal-marda ta' Wilson f'pazjenti li ma jittollerawx terapija b'DPeniċillammina, fl-adulti, fl-adoloxxenti u fit-tfal ta' 5 snin jew aktar.
English: A large overdose of 40 g of trientine base resulted in selflimiting dizziness and vomiting with no other clinical sequelae or significant biochemical abnormalities reported.
Maltese: Doża eċċessiva kbira ta '40 g ta' bażi ta 'trientine rriżultat f'qarbija ta' sturdament u rimettar bl-ebda sequalae klinika oħra jew anormalitajiet bijokimiċi sinifikanti rrappurtati.