FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC reviewed all available data from pre-clinical studies, pharmacovigilance data, published literature and spontaneous reports on the risks associated with the adverse teratogenic effects and neuropsychiatric disorders of oral and topical retinoids.
Maltese: Sommarju ġenerali tal'evalwazzjoni xjentifika mill'PRAC Il-PRAC irreveda d-dejta kollha disponibbli minn studji prekliniċi, dejta tal-farmakoviġilanza, letteratura ppubblikata u rapporti spontanji dwar ir-riskji assoċjati mal-effetti teratoġeniċi avversi u disturbi newropsikjatriċi tar-retinojdi orali u topiċi.
English: • Inclusion of appointment table in the patient reminder card;
Maltese: • Inklużjoni tal-iskeda ta' appuntamenti fil-kard ta' tfakkira tal-pazjent;
English: The PRAC noted the systemic exposure is negligible following topical application of retinoids and that this does not appear to be affected to a clinically significant degree by the severity or extent of skin disease.
Maltese: Il'PRAC innota li l-esponiment sistemiku huwa negliġibbli wara applikazzjoni topika tar-retinojdi u li dan ma jidhirx li jiġi affettwat sa grad klinikament sinifikanti mis-severità jew mil-limitu tal-marda tal-ġilda.
English: Compliance with the PPP is crucial to a positive benefit/risk balance for these products; therefore, the adequacy of the pregnancy prevention measures, including PPPs, for the oral retinoids acitretin, alitretinoin and isotretinoin has been reviewed to ensure that the available materials effectively encourage contraception use, regular pregnancy testing and shared responsibility between patients, doctors and pharmacists in adhering to recommendations, and that this is communicated consistently and effectively for all products.
Maltese: għalhekk, l-adegwatezza tal-miżuri għall-prevenzjoni fit-tqala, inklużi l'PPPs, għar-'retinojdi orali acitretin, alitretinoin u isotretinoin ġiet irriveduta sabiex jiġi żgurat li l-materjal disponibbli jinkoraġġixxi b'mod effettiv l-użu tal-kontraċezzjoni, ittestjar tat-tqala regolari u responsabbiltà kondiviża bejn ilpazjenti, it-tobba u l-ispiżjara biex tintlaħaq konformità mar-rakkomandazzjonijiet, u li dan jiġi kkomunikat b'mod konsistenti u effettiv għall-prodotti kollha.
English: The PRAC noted that despite the introduction of pregnancy prevention measures, including pregnancy prevention programmes (PPPs), cases of pregnancy during treatment with oral retinoid continue to be reported in the EU.
Maltese: Il-PRAC innota li minkejja l-introduzzjoni ta' miżuri għall-prevenzjoni fit-tqala, inklużi programmi għallprevenzjoni fit-tqala (PPS), fl-UE, għadhom qegħdin jiġu rrappurtati każijiet ta' tqala waqt kura b'retinojd orali.
English: PRAC considered that given the oncological indications of oral tretinoin and oral bexarotene, further risk minimisation measures (RMMs) for these products regarding teratogenic effects, such as strengthening the product information (PI) and additional risk minimisation measures (aRMMs) would not provide an added value given the specialist management, the population at risk and the nature of the illness.
Maltese: Il-PRAC ikkunsidra li minħabba l'indikazzjonijiet onkoloġiċi ta' tretinoin orali u bexarotene orali, miżuri tal-imminimizzar tar-riskju ulterjuri (RMMs) għal dawn il-prodotti fir-rigward tal-effetti teratoġeniċi, bħat-tisħiħ tal'informazzjoni dwar il-prodott (PI) u miżuri tal-imminimizzar tar-riskju addizzjonali (aRMMs) ma jipprovdux valur miżjud minħabba l-immaniġġjar speċjalista, il-popolazzjoni f'riskju u n natura tal'marda.
English: • The PRAC considered the totality of the data submitted, including responses from the marketing authorisation holders with regard to the consistency and effectiveness of existing routine and additional risk minimisation measures for oral and topical retinoids-containing medicinal products in relation to teratogenic effects and neuropsychiatric disorders.
Maltese: • Il-PRAC ikkunsidra t-totalità tad-dejta ppreżentata, inklużi tweġibiet mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq fir-rigward tal-konsistenza u l-effettività tal-miżuri tal imminimizzar tar-riskju ta' rutina eżistenti u addizzjonali għall-prodotti mediċinali li fihom retinojdi orali u topiċi fir-rigward tal-effetti teratoġeniċi u d-disturbi newropsikjatriċi.
English: • Patient signature of the physician checklist/acknowledgement form;
Maltese: • Firma tal-pazjent tal-lista ta' kontroll/formola ta' rikonoxximent tat-tabib;
English: • The PRAC also concluded that there was a need to further harmonise and streamline the measures in the PPP including associated educational materials for the oral retinoids acitretin, alitretinoin and isotretinoin to ensure these are optimal to support discussions between patients and healthcare professionals on the risks and the associated risk minimisation measures.
Maltese: • Il-PRAC ikkonkluda wkoll li kien hemm ħtieġa għal aktar armonizzazzjoni u ssimplifikar tal-miżuri fil-PPP inkluż materjal edukattiv assoċjat għar-retinojdi orali acitretin, alitretinoin u isotretinoin sabiex jiġi żgurat li dawn ikunu ottimali biex jappoġġjaw diskussjonijiet bejn il-pazjenti u l professjonisti tal-kura tas-saħħa dwar ir-riskji u l-miżuri tal-imminimizzar tar-riskju assoċjati.
English: For tretinoin and bexarotene, it was considered that in light of the oncological indications, specialist management in a hospital setting and population at risk that existing risk minimisation was appropriate and proportionate.
Maltese: Għal tretinoin u bexarotene, ġie kkunsidrat li fid-dawl talindikazzjonijiet onkoloġiċi, l-immaniġġjar ta' speċjalista f'ambjent ta' sptar u l-popolazzjoni f'riskju, li l-imminimizzar tar-riskju eżistenti kien xieraq u proporzjonat.
English: The PRAC has also recommended that educational materials be distributed via electronic channels such as QR codes, and websites to make better use of the existing technology bearing in mind the young patient population using these products.
Maltese: Il-PRAC irrakkomanda wkoll li l materjal edukattiv jiġi ddistribwit permezz ta' kanali elettroniċi bħall-kodiċijiet QR, u siti web sabiex isir użu aħjar tat-teknoloġija eżistenti filwaqt li tiġi kkunsidrata l-popolazzjoni ta' pazjenti żgħażagħ li jużaw dawn il-prodotti.
English: In this respect, the PRAC recommended amendments to the product information, including harmonising the warnings and precautions of use for the oral retinoids acitretin, alitretinoin and isotretinoin to reflect the teratogenic risk associated with their use and communication to healthcare professionals through a direct healthcare professional communication.
Maltese: F'dan ir-rigward, il-PRAC irrakkomanda emendi fl-informazzjoni dwar il-prodott, inkluża larmonizzazzjoni tat-twissijiet u tal-prekawzjonijiet tal-użu għar-retinojdi orali acitretin, alitretinoin u isotretinoin, sabiex jiġi rifless ir-riskju teratoġeniku assoċjat mal-użu tagħhom u komunikazzjoni lill professjonisti tal-kura tas-saħħa permezz ta' komunikazzjoni diretta għall-professjonisti tal-kura tas-saħħa.
English: Although the underlying risk of psychiatric disorders within the patient populations can be significant, it is advisable that patients taking oral retinoids are warned about the potential risk of psychiatric reactions and the signs and symptoms to look out for.
Maltese: Għalkemm ir-riskju sottostanti ta' disturbi psikjatriċi fil-popolazzjonijiet tal-pazjent jista' jkun konsiderevoli, huwa rakkomandat li l-pazjenti li qegħdin jieħdu retinojdi orali jiġu mwissija dwar ir-riskju potenzjali ta' reazzjonijiet psikjatriċi u s-sinjali u s-sintomi li għandhom joqogħdu attenti għalihom.
English: Given the indications and patients populations that use acitretin, alitretinoin and isotretinoin, it was considered that any use of these oral retinoids in female patients at risk of pregnancy must be in accordance with the conditions of a pregnancy prevention programme (PPP).
Maltese: Minħabba l-indikazzjonijiet u l-popolazzjonijiet tal-pazjenti li jużaw acitretin, alitretinoin u isotretinoin, ġie kkunsidrat li kwalunkwe użu ta' dawn ir-retinojdi orali f'pazjenti nisa f'riskju ta' tqala għandu jkun f'konformità mal-kundizzjonijiet ta' programm għallprevenzjoni fit-tqala (PPP).
English: • The PRAC further considered that for the oral retinoids acitretin, alitretinoin and isotretinoin a drug utilisation study with a complementary survey should be conducted to assess the effectiveness of the proposed updated risk minimisation measures.
Maltese: • Il-PRAC ikkunsidra wkoll li għar-retinojdi orali acitretin, alitretinoin u isotretinoin għandu jsir studju dwar l-użu magħmul mill-mediċina bi stħarriġ komplementari sabiex jivvaluta l-effettività tal-miżuri tal-imminimizzar tar-riskju aġġornati proposti.
English: Overall, the PRAC concludes that the benefit-risk balance of medicinal products containing retinoids remains favourable, but that marketing authorisation(s) should be varied for both the oral and topical retinoids to ensure risks associated with the adverse teratogenic effects and neuropsychiatric disorders are accurately and consistently addressed, as appropriate.
Maltese: B'mod globali, il-PRAC jikkonkludi li l-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti mediċinali li fihom ir-retinojdi jibqa' favorevoli, iżda li l-awtorizzazzjoni(jiet) għat-tqegħid fis-suq għandhom jiġu varjati kemm għar-retinojdi orali kif ukoll topiċi sabiex jiġi żgurat li r-riskji assoċjati mal-effetti teratoġeniċi avversi u disturbi newropsikjatriċi jiġu indirizzati b'mod eżatt u konsistenti, kif xieraq.
English: In addition, the PRAC recommended changes to the educational materials for the oral retinoids (acitretin, alitretinoin and isotretinoin) to ensure healthcare professionals and patients are informed about the risks associated with oral retinoids (acitretin, alitretinoin and isotretinoin) in pregnant women and women of child-bearing potential and on the measures necessary to minimise the risk.
Maltese: alitretinoin u isotretinoin) sabiex jiġi żgurat li l'professjonisti tal-kura tas-saħħa u l-pazjenti jiġu infurmati dwar ir-riskji assoċjati mar-retinojdi orali (acitretin, alitretinoin u isotretinoin) f'nisa tqal u f'nisa li jistgħu joħorġu tqal u dwar il-miżuri meħtieġa sabiex jiġi mminimizzat ir'riskju.
English: The CHMP clarified that the communication plan should be modified to say ‘healthcare professionals who may be involved in the management of patients treated with retinoids'.
Maltese: Is-CHMP iċċara li l-pjan ta' komunikazzjoni għandu jiġi mmodifikat biex jgħid “professjonisti tal-kura tas-saħħa li jistgħu jiġu nvoluti fil-ġestjoni ta' pazjenti kkurati bir-retinojdi”.
English: Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Maltese: Opinjoni tas'CHMP Wara li rreveda r-rakkomandazzjoni tal-PRAC, is-CHMP jaqbel mal-konklużjonijiet u mar-raġunijiet globali tal-PRAC għal rakkomandazzjoni.
English: Given this and the negligible systemic exposure following topical use, the PRAC considered that no further risk minimization activities are deemed necessary.
Maltese: Minħabba dan u l-esponiment sistemiku negliġibbli wara għoti topiku, mhi meqjusa meħtieġa l-ebda attività tal-imminimizzar tar-riskju ulterjuri.
English: Inovelon contains the active substance rufinamide.
Maltese: Inovelon fih is-sustanza attiva rufinamide.
English: Further information on Inovelon 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: Inovelon received a marketing authorisation valid throughout the EU on 16 January 2007.
Maltese: Inovelon irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-16 ta' Jannar 2007.
English: Other information about Inovelon
Maltese: Informazzjoni oħra dwar Inovelon
English: This reduces the likelihood of a seizure occurring.
Maltese: Dan inaqqas il-probabbiltà ta' attakk ta' puplesija.
English: Lennox-Gastaut syndrome is rare, and Inovelon was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2004.
Maltese: Is-sindrome ta' Lennox-Gastaut huwa rari, u Inovelon ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl-20 ta' Ottubru 2004.
English: In older patients, treatment usually starts with a dose of 200 or 400 mg daily.
Maltese: F'pazjenti ikbar fl-età, il-kura normalment tibda b'doża ta' 200 jew 400 mg kuljum.
English: In a main study involving 139 patients aged between 4 and 30 years (three quarters of them below 17 years old) Inovelon caused a reduction in the number and severity of seizures.
Maltese: Fi studju ewlieni li involva 139 pazjent ta' bejn 4 u 30 sena (tliet kwarti minnhom taħt is-17-il sena), Inovelon ikkawża tnaqqis fin-numru u fis-severità ta' attakki ta' puplesija.
English: Patients adding Inovelon also had a 42.5% reduction in the number of ‘tonic-atonic' seizures (a common type of fit in patients with Lennox-Gastaut syndrome that often involves the patient dropping to the floor), compared with a 1.9% increase in those adding placebo.
Maltese: Il-pazjenti li żiedu Inovelon kellhom ukoll tnaqqis ta' 42.5 % fin-numru ta' attakki ta' puplesija “toniċiatoniċi” (tip komuni ta' aċċessjoni f'pazjenti bis-sindrome ta' Lennox-Gastaut li spiss jara l-pazjent jaqa' mal-art), meta mqabbel ma' żieda ta' 1.9 % f'dawk li żiedu l-plaċebo.
English: Patients taking Inovelon had a 35.8% reduction in the total number of seizures, falling from an average of 290 seizures in the four-week period before Inovelon was started.
Maltese: Il-pazjenti li ħadu Inovelon kellhom tnaqqis ta' 35.8 % fin-numru totali ta' attakki ta' puplesija, li niżel minn medja ta' 290 attakk ta' puplesija fil-perjodu ta' erba' ġimgħat qabel inbeda Inovelon.
English: Inovelon is used as an add-on to other anti-epileptic medicines.
Maltese: Inovelon jintuża bħala żieda ma' mediċini antiepilettiċi oħra.
English: By attaching to the channels, rufinamide prevents them switching from an inactive state to an active state.
Maltese: Billi jeħel mal-kanali, ir-rufinamide jipprevjenihom milli jaqilbu minn stat inattiv għal stat attiv.
English: As for all medicines, data on the use of Inovelon are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Inovelon hija ssorveljata kontinwament.
English: What are the risks associated with Inovelon?
Maltese: X'inhuma r-riskji assoċjati ma' Inovelon?
English: Treatment in children less than 4 years of age generally starts with a daily dose of 10 mg per kilogram body weight.
Maltese: Il-kura fi tfal ta' età ta' inqas minn 4 snin ġeneralment tibda b'doża ta' kuljum ta' 10 mg għal kull kilogramma tal-piż tal-ġisem.
English: Its symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Maltese: Is-sintomi tiegħu jinkludu bosta tipi ta' attakki ta' puplesija (aċċessjonijiet), attività elettrika abnormali fil-moħħ, diżabilità relatata mat-tagħlim u problemi fl-imġiba.
English: The active substance in Inovelon, rufinamide, acts by attaching to special channels (sodium channels) on brain cells that control their electrical activity.
Maltese: Is-sustanza attiva f'Inovelon, ir-rufinamide, taġixxi billi teħel ma' kanali speċjali (kanali tas-sodju) fuq iċ-ċelloli tal-moħħ li jikkontrollaw l-attività elettrika tagħhom.
English: There was a 1.6% reduction in the patients who added placebo to their existing treatment.
Maltese: Kien hemm tnaqqis ta' 1.6 % fil-pazjenti li żiedu plaċebo mal-kura eżistenti tagħhom.
English: How is Inovelon used?
Maltese: Inovelon?
English: Inovelon is an epilepsy medicine used to treat patients aged one year or older who have LennoxGastaut syndrome, a rare type of epilepsy that usually affects children but which can continue into adulthood.
Maltese: Inovelon huwa mediċina tal-epilessija li tintuża biex tikkura pazjenti ta' sena jew aktar li jkollhom issindrome ta' Lennox-Gastaut, tip rari ta' epilessija li normalment jaffettwa lit-tfal iżda li jista' jdum sa meta jsiru adulti.
English: What benefits of Inovelon have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Inovelon li ħarġu mill-istudji?
English: For the full list of side effects of Inovelon, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Inovelon, ara l-fuljett ta' tagħrif.
English: Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children.
Maltese: Is-sindrome ta' Lennox-Gastaut huwa wieħed mill-aktar forom severi ta' epilessija fittfal.
English: However, other analyses showed that doses based on body weight in children aged 1 to 4 years produced similar levels of the medicine in the body to those seen with standard doses in older patients.
Maltese: Madankollu, analiżijiet oħra wrew li dożi bbażati fuq il-piż tal-ġisem fi tfal ta' sena (1) sa 4 snin ipproduċew livelli simili tal-mediċina fil-ġisem għal dawk li dehru b'dożi standard f'pazjenti ikbar fl-età.
English: The company also presented the results of a study showing that the oral suspension produced the same levels of the active substance in the blood as the tablets.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' studju li juru li s-sospensjoni orali pproduċiet l-istess livelli tas-sustanza attiva fid-demm bħall-pilloli.
English: Side effects reported with Inovelon are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Inovelon huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The most common side effects with Inovelon (seen in more than 1 in 10 patients) are sleepiness, headache, dizziness, vomiting, and tiredness.
Maltese: L-effetti sekondarji l-aktar komuni b'Inovelon (li dehru f'aktar minn pazjent 1 minn kull 10) huma ngħas, uġigħ ta' ras, sturdament, rimettar u għeja.
English: Inovelon must not be used in patients who are hypersensitive (allergic) to rufinamide, triazole derivatives (such as some medicines used to treat fungal infections) or any of the other ingredients.
Maltese: Inovelon m'għandux jintuża f'pazjenti li huma ipersensittivi (allerġiċi) għar-rufinamide, għad-derivattivi tat-triazole (bħal xi mediċini li jintużaw biex jikkuraw infezzjonijiet fungali) jew għal kwalunkwe ingredjent ieħor.
English: How does Inovelon work?
Maltese: Kif jintuża Inovelon?
English: Inovelon can only be obtained with a prescription and treatment should be started by a paediatrician (a doctor specialised in treating children) or a neurologist (a doctor who treats brain disorders) experienced in the treatment of epilepsy.
Maltese: Id-doża ta' Inovelon tiddependi mill-età u l-piż tal-pazjent u jekk il-pazjent ikunx qiegħed jieħu wkoll valproate (mediċina antiepilettika oħra).
English: The main measures of effectiveness were the change in the number of seizures in the four weeks after Inovelon or placebo was added, compared with the four weeks before it was added, as well as the change in severity of seizures assessed on a 7-point scale by the patient's parent or guardian.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fin-numru ta' attakki ta' puplesija fl-erba' ġimgħat wara li żdied Inovelon jew plaċebo, meta mqabbel mal-erba' ġimgħat qabel żdied, kif ukoll il-bidla fis-severità talattakki ta' puplesija vvalutata fuq skala ta' 7- punti mill-ġenitur tal-pazjent jew mill-persuna li tieħu ħsiebu.
English: This dampens down the activity of the brain cells and prevents abnormal electrical activity from spreading through the brain.
Maltese: Dan inaqqas l-attività taċ-ċelloli tal-moħħ u jipprevjeni l-attività elettrika abnormali milli tinfirex fil-moħħ.
English: Given that the disease behaves the same way in both age groups, Inovelon could therefore be expected to act similarly in children aged 1 to 4 years.
Maltese: Minħabba li l-marda ġġib ruħha bl-istess mod fiż-żewġ gruppi ta' età, għalhekk Inovelon seta' jiġi mistenni li jaġixxi b'mod simili fi tfal ta' sena (1) sa 4 snin.
English: The absolute oral bioavailability is >90%.
Maltese: Il-bijodisponibilità orali assoluta hi >90%.
English: System/Organ Class
Maltese: Sistema/Klassifikazzjoni talOrgani
English: The active substance is prucalopride.
Maltese: Is-sustanza attiva hi prucalopride.
English: B-2300 Turnhout Belgium
Maltese: B-2300 Turnhout Il-Belġju
English: TQT study
Maltese: Studju TQT
English: I-04100 Borgo San Michele (Latina) Italy
Maltese: Borgo San Michele (Latina) L-Italja
English: Manufacturer Sanico NV Veedijk 59
Maltese: Il-Manifattur Sanico NV Veedijk 59
English: R107504, R084536 and R104065 (formed by O-demethylation) were identified as minor plasma metabolites.
Maltese: R107504, R084536 u R104065 (iffurmati b'O-demetilizzjoni) kienu identifikati bħala metaboliti minuri fil-plażma.
English: Lactose monohydrate (see section 2), microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), macrogol.
Maltese: Lactose monohydrate (ara sezzjoni 2), microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), macrogol.
English: Prucalopride is a dihydrobenzofurancarboxamide with gastrointestinal prokinetic activities.
Maltese: Prucalopride hu dihydrobenzofurancarboxamide b'attivitajiet gastrointestinali prokinetiċi.
English: Pharmacotherapeutic group: Other drugs for constipation, ATC code: A06AX05.
Maltese: Mediċini oħrajn kontra l-istitikezza, Kodiċi ATC: A06AX05.
English: Lactose monohydrate Microcrystalline cellulose Colloidal silicon dioxide Magnesium stearate
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Colloidal silicon dioxide Magnesium stearate
English: Prucalopride had no clinically relevant effects on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives.
Maltese: Prucalopride ma kellu l-ebda effetti rilevanti fuq il-farmakokinetika ta' warfarin, digoxin, alkoħol, paroxetine jew kontraċettivi orali.
English: Table 1: Adverse Drug Reactions (ADRs) Associated with Resolor
Maltese: Tabella 1: Reazzjonijiet Avversi għall-Mediċina (ADRs) Assoċjati ma' Resolor
English: Tablet coating Hypromellose Lactose monohydrate Triacetin
Maltese: Kisja tal-pillola Hypromellose Lactose monohydrate Triacetin
English: Each pack contains 7 x 1, 14 x 1, 28 x 1 or 84 x 1 film-coated tablet.
Maltese: Kull pakkett fih 7 x 1, 14 x 1, 28 x 1 jew 84 x 1 pillola miksija b'rita.
English: Prucalopride is extensively distributed, and has a steady-state volume of distribution (Vdss) of 567 litres.
Maltese: Prucalopride jiġi ddistribwit b'mod estensiv, u għandu volum ta' distribuzzjoni fiss (Vdss) ta' 567 litru.
English: 7 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 84 x 1 film-coated tablets
Maltese: 7 x 1 pilloli miksija b'rita 14 x 1 pilloli miksija b'rita 28 x 1 pilloli miksija b'rita 84 x 1 pilloli miksija b'rita
English: The most frequently reported adverse reactions associated with Resolor 2 mg therapy are headache (17.8%) and gastrointestinal symptoms (abdominal pain (13.7%), nausea (13.7%) and diarrhoea (12.0%)).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti assoċjati mat-terapija b'Resolor 2 mg huma wġigħ ta' ras (17.8%) u sintomi gastrointestinali (uġigħ addominali (13.7%), nawsja (13.7%) u dijarea (12.0%)).
English: Resolor contains lactose
Maltese: Resolor fih lactose
English: The 2 mg tablet also contains iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Maltese: Il-pillola ta' 2 mg fiha wkoll iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
English: Resolor has been shown not to cause rebound phenomena, nor to induce dependency.
Maltese: Intwera li Resolor ma jikkawżax fenomeni rebound, u lanqas ma jwassal għad-dipendenza.
English: Rectal haemorrhage
Maltese: Emorraġija rektali
English: Via C. Janssen
Maltese: Via C.