FrancophonIA/ELRC3.0 huggingface dataset:
English: • lower blood sugar than normal (hypoglycaemia)
Maltese: • zokkor aktar baxx fid-demm minn normal (ipoglikemja)
English: Very rare skin reactions (e.g. urticaria, pruritis, rash)
Maltese: Rari ħafna reazzjonijiet fil-ġilda (eż. urtikarja, ħakk, raxx)
English: EU/1/03/258/014, 56 tablets, component of a 112 tablet multipack.
Maltese: FIS-SUQ EU/1/03/258/014, 56 pillola, parti minn pakkett multiplu b'112 pillola
English: In addition, rosiglitazone inhibited ovarian oestradiol and progesterone synthesis and lowered plasma levels of these hormones resulting in effects on oestrus/menstrual cycles and fertility (see section 4.4).
Maltese: Barra minn hekk, rosiglitazone jostakola is-sintesi ta' l-oestradiol ta' l-ovarju u l-progesterone u baxxa l-livelli filplażma ta' dawn l-ormoni biex b'hekk wassal għal effetti fuq iċ-ċikli oestrus/menstruwali u fertilità (ara sezzjoni 4.4).
English: Pink film-coated tablets marked "gsk" on one side and "4/1000" on the other.
Maltese: Pilloli roża miksija b'rita, bil-marka “gsk” fuq naħa waħda u “4/1000” fuq in-naħa l-oħra.
English: Frequency categories are based on information available from metformin Summary of Product Characteristics available in the EU.
Maltese: Kategoriji tal-frekwenza huma bbażati fuq informazzjoni li hemm fis-Sommarju tal-Karatteristici tal-Prodott disponibbli fl-UE.
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience with rosiglitazone (see section 4.8).
Maltese: Fl-esperjenza b'rosiglitazone wara t-tqegħid fis-suq, kien hemm rapporti rari ta' ħsara fil-funzjoni taċċelloli tal-fwied (ara sezzjoni 4.8).
English: Immune system disorders (see Skin and subcutaneous tissue disorders) anaphylactic reaction
Maltese: Mard tas-sistema immuni (ara mard tal-ġilda u tat-tessuti ta' taħt il-ġilda) reazzjoni anafilattika
English: Avandamet tablets are a combination of two different medicines called rosiglitazone and metformin.
Maltese: Il-pilloli ta' Avandamet huma kumbinazzjoni ta' żewġ mediċini differenti li jisimhom rosiglitazone u metformin.
English: Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis, - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation, - by delaying intestinal glucose absorption.
Maltese: Metformin jista' jaġixxi permezz ta' tlett mekkaniżmi: - permezz ta' tnaqqis fil-produzzjoni tal-glukożju fil-fwied billi jżomm lura glukoneoġenesi u glajkoġenoliżi - fil-muskolu, billi jżid ftit is-sensitività għall-insulina u b'hekk itejjeb l-assorbiment u l-użu periferali tal-glukożju.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg tablets rosiglitazone/metformin HCl
Maltese: TAL-PRODOTT MEDIĊINALI AVANDAMET 2 mg/1000 mg pilloli rosiglitazone/metformin HC1
English: AVANDAMET tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Maltese: AVANDAMET fih il-lactose u għalhekk m'għandux jingħata lil pazjenti bi problemi rari ereditarji ta' intolleranza għall-galattożju, defiċjenza Lapp lactase jew meta l-ġisem ma jassorbix sew il-glukożju/galattożju.
English: For dose-related adverse reactions the frequency category reflects the higher dose of rosiglitazone.
Maltese: Għar-reazzjonijiet sekondarji relatati mad-doża l-kategorija ta' frekwenza tirrifletti l-ogħla doża tar-rosiglitazone.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg tablets rosiglitazone/metformin HCl
Maltese: AVANDAMET 1 mg/500 mg pilloli rosiglitazone/metformin HC1
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see section 4.4).
Maltese: Prodott mediċinali li m'għadux awtorizzat mediċinali katajoniċi li jiġu eliminati permezz ta' sekrezzjoni tubulari renali jingħaw flimkien (ara sezzjoni 4.4).
English: In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
Maltese: Studji in vitro juru li rosiglitazone huwa fil-biċċa l-kbir metaboliżżat minn CYP2C8, b'kontribut żgħir minn CYP2C9.
English: Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
Maltese: Pazjenti li esperjenzaw ACS ma ġewx studjati fi studji kliniċi kkontrollati b'rosiglitazone.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg tablets rosiglitazone/metformin HCl
Maltese: AVANDAMET 4 mg/1000 mg pilloli rosiglitazone/metformin HC1
English: Furthermore, AVANDAMET should be used with caution during concomitant administration of cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) due to the effect on metformin pharmacokinetics (see section 4.5).
Maltese: Barra minn hekk, AVANDAMET għandu jintuża b'attenzjoni meta jingħata flimkien ma' prodotti mediċinali katajoniċi li jiġu eliminati permezz ta' sekrezzjoni tubulari renali (e.ż. cimetidine) minħabba l-effett fuq il-farmakokinetika tal-metformin (ara sezzjoni 4.5).
English: Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Maltese: L-irbit ta' rosiglitazone mal-proteini fil-plażma huwa għoli (madwar 99.8%) u mhux affetwat millkonċentrazzjoni jew l-eta'.
English: AVANDAMET is contraindicated in patients with:
Maltese: Tfal u adoloxxenti:
English: HOW TO TAKE AVANDAMET
Maltese: Ieqaf ieħu Avandamet
English: • rapid and excessive weight gain caused by fluid retention
Maltese: • żieda rapida u eċċessiva fil-piż ikkawżata minn ritenzjoni ta' fluwidu
English: BEFORE YOU TAKE AVANDAMET
Maltese: QABEL MA TIEĦU AVANDAMET
English: Conditions to look out for
Maltese: Prekawzjonijiet oħra
English: • allergic reactions
Maltese: • reazzjonijiet allerġiċi
English: Yellow film-coated tablets marked "gsk" on one side and "1/500" on the other.
Maltese: Pilloli sofor miksija b'rita, bil-marka “gsk” fuq naħa waħda u “1/500” fuq in-naħa l-oħra.
English: However, rosiglitazone promoted differentiation and reversal of mutagenic changes in human colon cancer cells in vitro.
Maltese: Madankollu, in vitro, rosiglitazone għen fid-distinzjoni u rrevoka ta' tibdil mutaġeniku fiċ-ċelloli kanċeroġeni tal-kolon uman.
English: Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Maltese: Għandu jkun hemm kawtela f'pazjenti ta' aktar minn 75 sena minħabba esperjenza limitata f'dan il-grupp ta' pazjenti.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Maltese: Fil-bniedem, indipendentement mill-azzjoni tiegħu fuq il-gliċemija, metformin għandu effetti favorevoli fuq il-metaboliżmu lipidu.
English: The use of AVANDAMET in combination with a sulphonylurea or insulin may be associated with increased risks of fluid retention and heart failure (see section 4.8).
Maltese: L-użu ta' AVANDAMET flimkien ma sulphonylurea jew insulina jista' jkun assoċjat ma riskji akbar ta' retenzjoni tal-fluwidu jew insuffiċjenza tal-qalb (ara sezzjoni 4.8).
English: The maximum dose is 4 mg rosiglitazone and 1000 mg metformin, taken twice a day.
Maltese: Id-doża massima hija ta' 4mg ta' rosiglitazone u 1000mg ta' metformin, mehuda darbtejn kuljum.
English: No statistically significant difference was observed between the absorption characteristics of rosiglitazone and metformin from the AVANDAMET tablet and those obtained from rosiglitazone maleate and metformin hydrochloride tablets, respectively.
Maltese: L-ebda differenza statistikament sinifikanti ma ġiet osservata bejn il-karatteristiċi ta' assorbiment ta' rosiglitazone u metformin mill-pillola AVANDAMET u dawk miġbura minn pilloli ta' rosiglitazone maleate u metformin hydrochloride, rispettivament.
English: These strengths are supplied in blister packs containing 28, 56, 112, 3x112 or 360 film-coated tablets.
Maltese: Dawn id-dożi issibhom f'pakki blister li fihom 28, 56, 112, 3x112 jew 360 pillola miksijin b'rita.
English: Very rare vitamin B12 deficiency7
Maltese: Rari ħafna defiċjenza tal-vitamina
English: Allergic reactions: These are very rare in people taking Avandamet.
Maltese: Reazzjonijiet allerġiċi : Dawn huma rari ħafna f'nies li jieħdu Avandamet.
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Maltese: Tel: + 39 (0)45 9218 111
English: Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5
Maltese: Mard tal-fwied u tal-marrara indeboliment tal-funzjoni tal-fwied, indikat primarjament minn għoli fl-enzimi tal-fwied 5
English: Eye disorders macular oedema
Maltese: Monitoraġġ tal-funzjoni tal-fwied
English: • Don't breast-feed while you are taking Avandamet.
Maltese: • Avandamet m'huwiex rakkomandat waqt it-tqala.
English: These may be signs of liver problems:
Maltese: Id-Dententur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq:
English: Yellow film-coated tablets marked "gsk" on one side and "2/1000" on the other.
Maltese: Pilloli sofor miksija b'rita, bil-marka “gsk” fuq naħa waħda u “2/1000” fuq in-naħa l-oħra.
English: • if you are going to have an X-ray using an injected dye.
Maltese: • jekk tkun se tagħmel X-ray b'injezzjoni tal-kulur.
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking AVANDAMET should have their renal function monitored regularly (see sections 4.3 and 4.4).
Maltese: Billi metformin jitneħħa mill-ġisem permezz tal-kliewi, u l-funzjoni tal-kliewi fl-anzjani spiss tkun imnaqqsa, pazjenti anzjani li jieħdu AVANDAMET għandu jkollhom il-funzjoni tal-kliewi segwita regolarment (ara sezzjonijiet 4.3 u 4.4).
English: The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq jikkommetti li jwettaq l-istudji u l-attivitajiet addizjonali ta' farmakoviġilanza ddettaljati fil-Pjan ta' Farmakoviġilanza kif miftiehem f'verżjoni 4 tal-Pjan għall-Immaniġġjar tar-Riskju (RMP) ippreżentat f'Module 1.8.2 ta' l-Applikazzjoni għallAwtorizzazzjoni għat-Tqegħid fis-Suq u kull aġġornament ta' l-RMP miftiehem mis-CHMP.
English: Avandamet can be used alone or with a sulphonylurea, another medicine for diabetes.
Maltese: Avandamet jista' jintuża waħdu jew ma' sulphonylurea, mediċina oħra għad-dijabete.
English: Many of these patients reported concurrent peripheral oedema.
Maltese: Prodott mediċinali li m'għadux awtorizzat fil-frekwenza.
English: Patients with renal impairment
Maltese: − infezzjoni qawwija
English: Elderly: In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent.
Maltese: Minn ġabra ta' analiżi tal-farmakokinetika tal-popolazzjoni, l-età ma nstabitx li taffetwa lproċessi farmakokinetiċi ta' rosiglitazone b'xi mod sinifikanti.
English: Film-coated tablet.
Maltese: Tieħux aktar mid-doża rakkomandata.
English: AVANDAMET is not recommended for use in children and adolescents below 18 years of age as there are no data available on its safety and efficacy in this age group (see sections 5.1 and 5.2).
Maltese: AVANDAMET mhux rakkomandat għal użu fi tfal u adoloxxenti ta' taħt it-18-il sena għax m'hemmx biżżejjed informazzjoni dwar is-sigurta` u l-effikaċja tiegħu f'din l-eta (ara sezzjoni 5.1 u 5.2).
English: Premenopausal women have received rosiglitazone during clinical studies.
Maltese: Dan l-effett ta' l-ikel mhux ikkunsidrat klinikament sinifikanti.
English: Metabolism and nutrition disorders hypercholesterolaemia1 Common hypertriglyceridaemia Common hyperlipaemia weight increase increased appetite hypoglycaemia
Maltese: Metformin huwa biguanide b'effetti anti-ipergliċemiċi, li jbaxxu kemm il-livell bażi u l-livell ta' wara l-ikel tal-glukożju fil-plażma.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/004-006
Maltese: NUMRU(I) TA' L- AWTORIZZAZZJONI GĦALL-KUMMERĊ EU/1/03/258/016
English: • fluid in the lungs (pulmonary oedema) causing breathlessness
Maltese: • fluwidu fil-pulmun (edema pulmonari) li tikkawża qtugħ ta' nifs
English: Marketing Authorisation Holder: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Maltese: Great West Road, Brentford, Middlesex, TW8 9GS, Renju Unit.
English: 7 Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Maltese: B12 li f'każi rari ħafna jirriżulta f'effett kliniku sinifikanti ta' defiċjenza tal-vitamina
English: A large overdose of metformin (or coexisting risks of lactic acidosis) may lead to lactic acidosis which is a medical emergency and must be treated in hospital.
Maltese: Doża qawwija ta' metformin (jew riskji koeżistenti ta' aċidożi lattika) tista' twassal għal aċidożi lattika li hija emerġenza medika u li trid tiġi ttrattata fi sptar.
English: Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Maltese: Reazzjonijiet mhux mixtieqa għal kull terapija huma elenkati hawn taħt skond il-klassi tas-sistemi u lorgani u l-frekwenza assoluta.
English: - hypersensitivity to rosiglitazone, metformin hydrochloride or to any of the excipients - cardiac failure or history of cardiac failure (New York Heart Association (NYHA) stages I to IV) - an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4) - acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure - recent myocardial infarction - shock - hepatic impairment - acute alcohol intoxication, alcoholism (see section 4.4) - diabetic ketoacidosis or diabetic pre-coma - renal failure or renal dysfunction e.g. serum creatinine levels > 135 µmol/l in males and > 110 µmol/l in females and/or creatinine clearance < 70 ml/min (see section 4.4) - acute conditions with the potential to alter renal function such as: - dehydration - severe infection - shock - intravascular administration of iodinated contrast agents (see section 4.4) - lactation.
Maltese: Tieħux AVANDAMET: - jekk inti allerġiku (tbati minn sensittività eċċessiva) għal rosiglitazone u metformin jew xi wieħed mill-ingredjenti l-oħra ta' Avandamet (imniżżlin f'Sezzjoni 6) - jekk kellek attakk f'qalbek jew anġina severa, li qed tkun ikkurata l-isptar - jekk għandek insuffiċjenza tal-qalb, jew qatt kellek insuffiċjenza tal-qalb fil-passat - jekk għandek diffikultajiet biex tieħu n-nifs - jekk għandek mard tal-fwied - jekk tixrob alkoħol b'mod eċċessiv - jekk tixrob ħafna regoralment, jew jekk ikollok okkażżjonijiet fejn tixrob ħafna (binge drinking) - jekk kellek ketoaċidożi dijabetika ( kumplikazzjoni tad-dijabete li tikkawża telf kbir fil-piż,
English: In a sub-study at 18 months, add-on rosiglitazone dual therapy was non-inferior to the combination of sulphonylurea plus metformin for lowering HbA1c.
Maltese: F'sotto studju wara 18-il xahar, terapija doppja b'rosiglitazone miżjud ma kienetx inferjuri għat-taħlita ta' sulphonylurea flimkien ma' metformin biex tnaqqas HbA1c.
English: A more pronounced glucose-lowering effect was observed in obese patients.
Maltese: L-ebda metaboli ma ġew identifikati fil-bniedem.
English: • stomach pain, feeling sick (nausea), vomiting, diarrhoea or loss of appetite.
Maltese: • uġigħ fl-istonku, tħossok imqalla (dardir), rimettar, dijarrea u nuqqas ta' aptit.
English: 1 vial + 1 syringe + 1 needle + 1 adaptor + 2 alcohol pads
Maltese: kunjett 1 + siringa 1 + labra 1 + adapter 1 + 2kuxxinetti talalkoħol
English: MA (EU) number
Maltese: Numru tal-MA (UE)
English: EU/1/19/1356/001 IDACIO 40 mg/0.8 ml
Maltese: 40 mg/0.8 ml
English: Subcutaneous use vial (glass)
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Immediate Packaging
Maltese: Daqs tal-pakkett:
English: MA (EU) number (Invented) name
Maltese: Numru tal-EU Isem (ivvintat) Qawwa
English: Route of Administration
Maltese: Mnejn għandu jingħata
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Hetlioz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This summary was last updated in 07-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 07-2015.
English: The full EPAR and risk management plan summary for Hetlioz 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: These are usually mild or moderate in severity and temporary.
Maltese: Dawn normalment ikunu ħfief jew moderati bħala severità u temporanji.
English: Other information about Hetlioz
Maltese: Informazzjoni oħra dwar Hetlioz
English: This is a summary of the European public assessment report (EPAR) for Hetlioz.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Hetlioz.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hetlioz on 3 July 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Hetlioz fit-3 ta' Lulju 2015.
English: Because the number of patients with non-24-hour sleep-wake disorder is low, the disease is considered ‘rare', and Hetlioz was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 February 2011.
Maltese: Peress li n-numru ta' pazjenti b'disturb fl-irqad u l-qawmien mhux ta' 24 siegħa huwa baxx, il-marda hija kkunsidrata bħala ‘rari', u Hetlioz ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-23 ta' Frar 2011.
English: Hetlioz contains the active substance tasimelteon.
Maltese: Hetlioz fih is-sustanza attiva tasimelteon.
English: A risk management plan has been developed to ensure that Hetlioz is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Hetlioz jintuża bl-aktar mod sigur possibbli.
English: Why is Hetlioz approved?
Maltese: Għaliex ġie approvat Hetlioz?
English: The CHMP noted that only around 20% of patients would be able to benefit from treatment with Hetlioz, but in view of the lack of approved treatments for non-24-hour sleep-wake disorder, which is a debilitating condition, this modest response was still considered important.
Maltese: Is-CHMP innota li madwar 20% biss mill-pazjenti ser ikunu jistgħu jibbenefikaw mill-kura b'Hetlioz, iżda fid-dawl tan-nuqqas ta' kuri approvati għal disturb fl-irqad u l-qawmien mhux ta' 24 siegħa, li hija kundizzjoni debilitanti, dan ir-rispons modest xorta ġie kkunsidrat importanti.
English: Of the 10 patients who remained on Hetlioz, 9 people remained adjusted to 24-hour clock at the end of the study, compared with 2 of the 10 patients who were switched to placebo.
Maltese: Mill-10 pazjenti li baqgħu jieħdu Hetlioz, 9 minnhom baqgħu aġġustati għall-arloġġ ta' 24 siegħa fl-aħħar tal-istudju, meta mqabbel ma' 2 minn 10 pazjenti li qalbu għall-plaċebo.
English: The first study, which involved a total of 84 totally blind patients with non-24-hour sleep-wake disorder, compared Hetlioz with placebo (a dummy treatment).
Maltese: L-ewwel studju, li involva total ta' 84 pazjent kompletament għomja b'disturb fl-irqad u l-qawmien mhux ta' 24 siegħa, qabbel Hetlioz ma' plaċebo (kura finta).
English: The active substance in Hetlioz, tasimelteon, acts on the same receptors as melatonin to promote sleep and regulate sleep patterns.
Maltese: Issustanza attiva f'Hetlioz, it-tasimelteon, taħdem fuq l-istess riċetturi bħall-melatonina biex tippromwovi l-irqad u tirregola l-istil ta' rqad.
English: Non-24hour sleep-wake disorder is a condition that occurs almost exclusively in people who are completely blind, where patients have sleep patterns that are not synchronised with day and night and often follow a cycle that is longer than the standard 24-hour clock.
Maltese: Id-disturb fl-irqad u l-qawmien mhux għal 24 siegħa hija kundizzjoni li sseħħ kważi esklussivament f'nies li huma kompletament għomja, fejn il-pazjenti għandhom stil ta' rqad mhux sinkronizzat mal-jum u l-lejl u normalment isegwu ċiklu li huwa itwal mill-arloġġ ta' 24 siegħa standard.
English: 20% of patients who received Hetlioz (8 out of 40) were able to adjust to the 24-hour clock after 1 months of treatment, compared with around 3% of patients on placebo (1 out of 38).
Maltese: Il-kejl ewlieni tal-effikaċja kien ilperċentwal ta' pazjenti li setgħu jaġġustaw għall-arloġġ ta' 24 siegħa, li ġie kkalkolat billi ġie nnotat kif inbidel l-ammont ta' prodotti tat-tkissir tal-melatonina fl-awrina tal-pazjent maż-żmien. 20% talpazjenti li reċevew Hetlioz (8 minn 40) setgħu jaġġustaw għall-arloġġ ta' 24 siegħa wara xahar ta' kura, meta mqabbel ma' madwar 3% tal-pazjenti bil-plaċebo (1 minn 38).
English: What are the risks associated with Hetlioz?
Maltese: X'inhuma r-riskji assoċjati ma' Hetlioz?
English: The most common side effects with Hetlioz (which may affect more than 3 in 100 people) are headache, somnolence, nausea (feeling sick) and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni b'Hetlioz (li jistgħu jaffettwaw aktar minn 3 minn kull 100) huma uġigħ ta' ras, ngħas, nawżja (tħossok ma tiflaħx) u sturdament.
English: For the full list of all side effects and restrictions with Hetlioz, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Hetlioz, ara l-fuljett ta' tagħrif.
English: A hormone called melatonin plays a key role in co-ordinating the body's sleep-wake cycle.
Maltese: L-ormon imsejjaħ melatonina għandu rwol importanti fil-koordinazzjoni taċ-ċiklu tal-irqad u l-qawmien tal-ġisem.
English: Those patients who were able to adjust to the 24-hour clock (20 patients in total) were then given Hetlioz or placebo for a further 8 weeks to study how well the effect of Hetlioz was maintained.
Maltese: Dawk il-pazjenti li kienu kapaċi jaġġustaw għall-arloġġ ta' 24 siegħa (total ta' 20 pazjent) imbagħad ingħataw Hetlioz jew plaċebo għal 8 ġimgħat oħra biex jiġi studjat kemm jinżamm tajjeb l-effett ta' Hetlioz.
English: Hetlioz is a medicine used to treat totally blind adults with non-24-hour sleep-wake disorder.
Maltese: Hetlioz huwa mediċina li tintuża fil-kura ta' adulti kompletament għomja li għandhom disturb fl-irqad u l-qawmien mhux ta' 24 siegħa.
English: Hetlioz is available as 20 mg capsules and can only be obtained with a prescription.
Maltese: Hetlioz jiġi bħala kapsuli ta' 20 mg u jista' jinkiseb biss b'riċetta ta' tabib.
English: In people with normal perception of light and dark, melatonin is produced in hours of darkness and promotes sleep by acting on melatonin receptors in specific areas of the brain.
Maltese: F'nies b'perċezzjoni normali tad-dawl u d-dlam, il-melatonina tiġi prodotta fis-sigħat ta' dlam u tippromwovi l-irqad billi taħdem fuq ir-riċetturi tal-melatonina f'postijiet speċifiċi tal-moħħ.
English: What measures are being taken to ensure the safe and effective use of Hetlioz?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Hetlioz?
English: How is Hetlioz used?
Maltese: Kif jaħdem Hetlioz?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hetlioz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Hetlioz huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.