FrancophonIA/ELRC3.0 huggingface dataset:
English: The basal component of Ryzodeg (insulin degludec) forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose-lowering effect.
Maltese: Il-komponent bażilari ta' Ryzodeg (insulina degludec) jifforma multi-eżameri solubbli meta jingħata bħala injezzjoni minn taħt il-ġilda u jirriżulta f'depożitu li minnu l-insulina degludec tiġi assorbita kontinwament u bil-mod għal ġoċ-cirkolazzjoni u twassal għal effett uniformi u stabbli li jbaxxi lglukosju.
English: Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.5, 4.8 and 4.9).
Maltese: Ipogliċemija tista' sseħħ jekk id-doża tal-insulina tkun għolja wisq meta mqabbla mal-ħtieġa talinsulina (ara sezzjonijiet 4.5, 4.8 u 4.9).
English: Other side effects include:
Maltese: Tużax Ryzodeg:
English: Total exposure with Ryzodeg increases proportionally with increasing dose of the basal component (insulin degludec) and the mealtime component (insulin aspart) in type 1 and type 2 diabetes mellitus.
Maltese: L-espożizzjoni totali ta' Ryzodeg tiżdied b'mod proporzjonali maż-żieda fid-doża tal-parti bażilari (insulina degludec ) u l-parti tal-ħin tal-ikel (insulina aspart) f'pazjenti b'dijabete mellitus ta' tip 1 u tip
English: in patients with type 2 diabetes mellitus.
Maltese: Mediċini użati fid-dijabete.
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Ryzodeg 100 units/mL solution for injection in cartridge
Maltese: Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni f'skartoċċ
English: Beta-blockers may mask the symptoms of hypoglycaemia.
Maltese: • beta-blokkanti, użati fil-kura tal-pressjoni għolja fid-demm.
English: Combination of pioglitazone and insulin medicinal products Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac failure.
Maltese: Kombinazzjoni ta' pioglitazone u prodotti mediċinali tal-insulina Ġew irrapportati każijiet ta' insuffiċjenza kardijaka meta ġew użati fl-istess waqt pioglitazone u linsulina, speċjalment f'dawk il-pazjenti li għandhom fatturi ta' riskju għall-iżvilupp ta' insuffiċjenza kardijaka.
English: Difference: -0.05 [-0.18;0.08]
Maltese: Differenza: -0.05
English: Ryzodeg 100 units/mL solution for injection in cartridge Ryzodeg comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist injection needles.
Maltese: Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni f'skartoċċ Ryzodeg jiġi f'skartoċċ (Penfill) magħmul biex jintuża ma' sistemi tal-għoti ta' insulina ta' NovoNordisk u labar tal-injezzjoni NovoFine jew NovoTwist.
English: in two trials in type 2 diabetes mellitus (Table 2) and to insulin degludec (IDeg) o.d. plus insulin aspart (IAsp) 2-4 times daily in one trial in type 2 diabetes mellitus.
Maltese: Ryzodeg b.i.d. ġie pparagunat ma' insulina aspart 30 bifażiku (BIAsp 30) b.i.d. f'żewġ provi f'pazjenti b'dijabete mellitus ta' tip 2 (Tabella 2) u ma' insulina degludec (IDeg) o.d. flimkien ma' insulina aspart (IAsp) 2-4 darbiet kuljum f'prova waħda f'pazjenti b'dijabete mellitus ta' tip 2.
English: Difference: -0.03 [-0.20;0.14]
Maltese: Differenza: -0.03 [-0.
English: The following substances may increase the insulin requirement Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Maltese: Dawn is-sustanzi li ġejjin jistgħu jżidu l-ħtiġijiet tal-pazjent għall-insulina Kontraċettivi li jittieħdu mill-ħalq, thiazides, glukokortikojdi, ormoni tat-tirojde, simpatomimetiċi, ormon tat-tkabbir u danazol.
English: The primary analysis was time from randomisation to first occurrence of a 3-component major adverse cardiovascular event (MACE) defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
Maltese: L-analiżi primarja kienet iż-żmien mill-għażla b'mod arbitrarju sakemm seħħ l-ewwel avveniment kardjovaskulari avvers maġġuri (MACE -major adverse cardiovascular event) minn fost 3 komponenti definiti bħala mewt kardjovaskulari, infart mijokardijaku (IM) li ma kienx fatali u puplesija li ma kinitx fatali.
English: The ratio of mitogenic relative to metabolic potency for insulin degludec is comparable to that of human insulin.
Maltese: Għall-insulina degludec, il-proporzjon ta' potenza mitoġenika fir-rigward ta' potenza metabolika hija komparabbli għal dak tal-insulina umana.
English: 1 mL solution contains 100 units insulin degludec/insulin aspart* in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
Maltese: 1 mL ta' soluzzjoni fih 100 unità ta' insulina degludec/insulina aspart fil-proporzjoni 70/30 (ekwivalenti għal 2.56 mg insulin degludec u 1.05 mg insulin aspart)
English: Non-clinical data reveal no safety concerns for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
Maltese: Tagħrif mhux kliniku ma jiżvela l-ebda tħassib dwar is-sigurtà għall-bnedmin ibbażat fuq farmakoloġija tas-sigurtà, tossiċità minn dożi ripetuti, potenzjal karċinoġeniku u tossiċità fir-rigward tar-riproduzzjoni.
English: The half-life of the basal component (insulin degludec) at steady state is 25 hours independent of dose.
Maltese: Il-half-life tal-parti bażilari (insulina degludec ) fl-istat fiss hi ta' 25 siegħa,
English: Ryzodeg 100 units/mL solution for injection in cartridge The cartridge (Penfill) is designed to be used with Novo Nordisk delivery systems (durable devices for repeated use not included in the pack) and NovoFine/NovoTwist injection needles up to a length of 8 mm.
Maltese: L-iskartoċċ (Penfill) hu magħmul biex jintuża ma' sistemi ta' forniment ta' NovoNordisk (apparat li jiflaħ għall-istrapazz ta' użu ripetittiv, mhux inkluż fil-pakkett) u ma' labar għall-injezzjoni NovoFine/NovoTwist b'tul ta' mhux iżjed minn 8 mm.
English: There is no clinically relevant development of insulin antibodies after long-term treatment of Ryzodeg.
Maltese: M'hemm ebda żvilupp klinikament rilevanti ta' antikorpi għall-insulina wara trattament fit-tul b'Ryzodeg.
English: • Ryzodeg is given as an injection under the skin (subcutaneous injection).
Maltese: • Ryzodeg jingħata bħala injezzjoni taħt il-ġilda (injezzjoni subkutanea).
English: The cardiovascular safety of insulin degludec as compared to insulin glargine was confirmed (HR 0.91 [0.78; 1.06]) (Figure 2).
Maltese: Ġie kkonfermat li s-sigurtà kardjovaskulari ta' insulin degludec hija simili għal dik ta' insulin glargine (HR 0.91 [0.
English: In one trial of patients with type 2 diabetes mellitus treated with basal insulin, in need of treatment intensification with mealtime insulin, Ryzodeg o.d. was compared to IGlar o.d. plus IAsp o.d. over 26 weeks.
Maltese: F'prova waħda f'pazjenti bid-dijabete mellitus ta' tip 2 ittrattati b'insulina bażilari li għandhom bżonn ta' intensifikazzjoni tat-trattament b'insulina moghtija fil-ħin tal-ikel, Ryzodeg o.d. ġie pparagunat ma' IGlar o.d. flimkien ma' IAsp o.d. fuq medda ta' 26 ġimgħa.
English: 2 units selected
Maltese: Magħżula 2 unitajiet
English: Injection site reactions Uncommon Peripheral oedema
Maltese: Edima periferali
English: Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years.
Maltese: Ryzodeg jintuża għat-trattament tad-dijabete mellitus fl-adulti, fl-adolexxenti u fit-tfal mill-età ta' sentejn.
English: Do not use this medicine after the expiry date which is stated on the Penfill label and carton, after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-Penfill u fuq il-kartuna, wara ‘JIS'.
English: EU/1/12/806/007 5 cartridges of 3 mL EU/1/12/806/008 10 cartridges of 3 mL
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/806/007 5 skrataċ ta' 3 mL
English: The pharmacodynamic effect of Ryzodeg is distinctively separated for the two components (Figure 1), and the resulting action profile reflects the individual components, the rapid-acting insulin aspart and the basal component insulin degludec.
Maltese: L-effett farmakodinamiku ta' Ryzodeg hu separat b'mod distintiv għaż-żewġ komponenti (Figura 1) u l-profil ta' azzjoni li jirriżulta jirrifletti l-komponenti individwali, l-insulina aspart li taħdem fil-pront u l-insulina degludec li taħdem għal żmien twil aktar mis-soltu.
English: One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution 1 mL solution contains 100 units of insulin degludec/insulin aspart in the ration of 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Skartoċċ wieħed fih 300 unità ta' insulina degludec/insulina aspart f'soluzzjoni ta' 3 mL 1 mL ta' soluzzjoni fih 100 unità ta' insulina degludec/insulina aspart fil-proporzjoni ta' 70/30 (ekwivalenti għal 2.56 mg insulin degludec u 1.05 mg insulin aspart)
English: with IDeg o.d. plus IAsp 2-4 times daily) in type 2 diabetes mellitus.
Maltese: Pazjenti b'dijabete mellitus ta' tip 2.
English: Ratio: 0.29 [0.13;0.65]
Maltese: Proporzjon: 0.29 [0.
English: It might lead to cross-infection.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni.
English: A number of medicinal products are known to interact with glucose metabolism.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Numru ta' prodotti mediċinali huma magħrufa li jagħmlu interazzjoni mal-metaboliżmu tal-glucose.
English: Dose selector Dose button
Maltese: Jekk tuża Ryzodeg aktar milli suppost
English: Insulin degludec and insulin aspart bind specifically to the human insulin receptor and result in the same pharmacological effects as human insulin.
Maltese: L-insulina degludec u l-insulina aspart jingħaqdu speċifikament mar-riċettur tal-insulina umana u b'hekk jikkawża l-istess effetti farmakoloġiċi bħal dawk tal-insulina umana.
English: There is no difference in the pharmacodynamic effect of this medicinal product between elderly and younger patients.
Maltese: M'hemm l-ebda differenza fl-effett farmakokinetiku ta' dan il-prodott mediċinali bejn pazjenti anzjani u dawk iżgħar fl-età.
English: 2 Once-daily regimen + Metformin ± pioglitazone ± DPP-4 inhibitor 3 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose < 3.1 mmol/L or by the patient needing third party assistance.
Maltese: Dan il-prodott mediċinali jista' jintuża fl-adolexxenti u fit-tfal minn sentejn 'il fuq ( ara sezzjoni 5.1).
English: • if you are allergic to insulin degludec, insulin aspart or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal insulina degludec, insulina aspart jew għal xi sustanza oħra ta' din il mediċina (elenkati fis-sezzjoni 6).
English: Each mL of solution contains 100 units insulin degludec/insulin aspart in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
Maltese: Kull millilitru ta' soluzzjoni fih 100 unità ta' insulina degludec/insulina aspart fil-proporzjon ta' 70/30 (ekwivalenti għal 2.56 mg insulina degludec and 1.05 mg insulina aspart).
English: The trial was designed as a non-inferiority trial to exclude a pre-specified risk margin of 1.3 for the hazard ratio (HR) of MACE comparing insulin degludec to insulin glargine.
Maltese: Il-prova ġiet maħluqa bħala prova ta' non-inferiority sabiex jiġi eskluż marġni ta' riskju speċifikat minn qabel ta' 1.3 għall-proporzjon ta' riskju (HR-hazard ratio) ta' MACE li qabbel insulin degludec ma' insulin glargine.
English: The full EPAR for HBVaxPro 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: HBVaxPro is available in two strengths (10 and 40 micrograms/ml).
Maltese: Jiġi f' żewġ qawwiet (10 u 40 mikrogramma/ml).
English: HBVaxPro hepatitis B vaccine (rDNA)
Maltese: HBVaxPro vaċċin kontra l-epatite B (rDNA)
English: The surface antigens are also ‘adsorbed'.
Maltese: L-antiġeni tas-superfiċje jiġu wkoll ‘adsorbiti'.
English: Other information about HBVaxPro
Maltese: Informazzjoni oħra dwar HBVaxPro
English: The European Commission granted a marketing authorisation valid throughout the European Union for HBVaxPro to Sanofi Pasteur MSD SNC on 27 April 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal HBVaxPro fis-27 ta' April 2001.
English: This is a summary of the European public assessment report (EPAR) for HBVaxPro.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal HBVaxPro.
English: The surface antigens in HBVaxPro are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Maltese: L-antiġeni tas-superfiċje f' HBVaxPro huma prodotti b' metodu magħruf bħala 'teknoloġija rikombitanti tad-DNA': dawn huma magħmula minn ħmira li tkun irċeviet ġene (DNA), li tagħmel ilħmira kapaċi tipproduċi l-proteini.
English: This summary was last updated in 02-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 04-2017.
English: HBVaxPro contains small amounts of ‘surface antigens' (proteins from the surface) of the hepatitis B virus.
Maltese: HBVaxPro fih ammonti żgħar ta' “antiġeni tas-superfiċje” (proteini mill-wiċċ) tal-virus tal-epatite B.
English: The most common side effects with HBVaxPro (seen in between 1 and 10 patients in 100) are reactions at the injection site, including temporary soreness, erythema (redness) and induration (hardening).
Maltese: L-effetti sekondarji l-aktar komuni b' HBVaxPro (li dehru f'bejn pazjent wieħed u għaxra minn kull 100) huma reazzjonijiet fis-sit tal-injezzjoni, inklużi irritazzjoni, eritemija (ħmura) u ebusija temporanji.
English: HBVaxPro is a vaccine.
Maltese: HBVaxPro huwa vaċċin.
English: HBVaxPro should not be given to people who may be hypersensitive (allergic) to the active substance or any of the other ingredients including substances present at very low (trace) levels, such as formaldehyde and potassium thiocyanate, used in the manufacture of the vaccine.
Maltese: HBVaxPro m'għandux jingħata lil persuni li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanza attiva jew għal xi sustanza oħra tiegħu, inklużi sustanzi li jkunu preżenti f' livelli baxxi ħafna (traċċi), bħallformaldejde u t-tijoċjanat tal-potassju, li jintużaw fil-manifattura tal-vaċċin.
English: This included the vaccines that contain the same active substance as HBVaxPro.
Maltese: Fost dawn kien hemm il-vaċċini li fihom l-istess sustanza attiva bħal HBVaxPro.
English: Why has HBVaxPro been approved?
Maltese: Għaliex ġie approvat HBVaxPro?
English: What is HBVaxPro?
Maltese: Kif jintuża HBVaxPro?
English: The timing of injections depends on the patient's age, strength of the immune system, response to vaccination and likelihood of exposure to the hepatitis B virus.
Maltese: Iż-żmien ta' meta jingħataw l-injezzjonijiet jiddependi mill-età talpazjent, mis-saħħa tas-sistema immunitarja, mir-rispons għat-tilqima u mill-probabbiltà li l-persuna tkun esposta għall-virus tal-epatite B.
English: When a person is given the vaccine, the immune system recognises the surface antigens as ‘foreign' and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf l-antiġeni tas-superfiċje bħala “barranin” u tipproduċi antikorpi kontrihom.
English: The company provided information comparing other vaccines with and without thiomersal, including studies of a vaccine that contains the same active substance as HBVaxPro.
Maltese: Il-kumpanija pprovdiet informazzjoni li tqabbel vaċċini oħra bit-tijomersal u mingħajru, inklużi studji dwar vaċċin li kien fih l-istess sustanza attiva bħal HBVaxPro.
English: What is the risk associated with HBVaxPro?
Maltese: X' inhuma r-riskji assoċjati ma' HBVaxPro?
English: Because the active substance used in HBVaxPro was already authorised for use in the EU, there have been no formal studies with HBVaxPro.
Maltese: Peress li s-sustanza attiva użata f' HBVaxPro diġà kienet awtorizzata għall-użu fl-UE, ma kienx hemm studji formali b' HBVaxPro.
English: The CHMP concluded that the removal of thiomersal from vaccines did not reduce their effectiveness in protecting against hepatitis B virus infection, but reduced their risks.
Maltese: Is-CHMP ikkonkluda li t-tneħħija tat-tijomersal mill-vaċċini ma naqqsitx l-effikaċja tagħhom filprotezzjoni kontra l-infezzjoni tal-epatite B, iżda naqqset ir-riskji tagħhom.
English: This helps to protect against infection with the hepatitis B virus.
Maltese: Dan jgħin fil-protezzjoni kontra l-infezzjoni bil-virus tal-epatite B.
English: It contains parts of the hepatitis B virus as the active substance.
Maltese: HBVaxPro fih partijiet tal-virus tal-epatite B bħala s-sustanza attiva.
English: HBVaxPro was specifically developed from a vaccine that was already in use in the European Union (EU), in order to produce a vaccine that does not contain the preservative thiomersal.
Maltese: HBVaxPro ġie speċifikatament żviluppat minn vaċċin li diġà kien qiegħed jintuża fl-Unjoni Ewropea (UE), sabiex jiġi prodott vaċċin li ma jkunx fih il-preżervattiv tijomersal.
English: HBVaxPro is used to vaccinate against hepatitis B in people who are at risk of exposure to the hepatitis B virus, as determined on the basis of official recommendations.
Maltese: HBVaxPro huwa vaċċin li jintuża għall-protezzjoni kontra l-epatite B f' persuni li jkunu f' riskju ta' esponiment għall-virus tal-epatite B, kif determinat abbażi tar-rakkomandazzjonijiet uffiċjali.
English: The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the viruses.
Maltese: Imbagħad issistema immunitarja tkun tista' tipproduċi antikorpi iktar malajr meta l-persuna tiġi esposta għallvirusis b' mod naturali.
English: The results of the studies presented showed that the thiomersal-free vaccines produced protective levels of antibodies against hepatitis B virus to a similar extent to the vaccines that contained thiomersal at the end of the vaccination course.
Maltese: Ir-riżultati tal-istudji ppreżentati wrew li l-vaċċini mingħajr it-tijomersal ipproduċew livelli ta' protezzjoni ta' antikorpi kontra l-virus tal-epatite B daqs il-vaċċini li kien fihom it-tijomersal fi tmiem il-kors ta' tilqim.
English: For the full list of all side effects reported with HBVaxPro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b' HBVaxPro, ara l-fuljett ta' tagħrif.
English: 27 March 2015 EMA/149624/2015
Maltese: EMA/149624/2015
English: Hydroxyzine-containing medicines have been authorised by national procedures in 22 Member States of the EU (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden and United Kingdom) plus Norway and Iceland.
Maltese: Il-mediċini li fihom hydroxyzine ġew awtorizzati minn proċeduri nazzjonali fi 22 Stat Membru tal-UE (lAwstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, Franza, ilĠermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Lussemburgu, Malta, in-Netherlands, il-Polonja, ilPortugall, is-Slovakkja, Spanja, l-Isvezja u r-Renju Unit) flimkien man-Norveġja u l-Iżlanda.
English: The review of hydroxyzine was initiated on 25 April 2014 at the request of Hungary, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' hydroxyzine nbdiet fil-25 ta' April 2014 fuq talba tal-Ungerija, skont l-Artikolu 31 tadDirettiva 2001/83/KE.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Maltese: 1 Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta lill-Istati Membri tal-Unjoni Ewropea (UE), l-Iżlanda, ilLiechtenstein u n-Norveġja.
English: • Use of hydroxyzine is contraindicated in patients with known acquired or congenital QT interval prolongation, or with a known risk factor for QT interval prolongation such as cardiovascular disease, significant electrolyte imbalance (hypokalaemia, hypomagnesaemia), family history of sudden cardiac death, significant bradycardia, or concomitant use of drugs known to prolong the QT interval and/or induce torsades de pointes.
Maltese: • L-użu ta' hydroxyzine huwa kontraindikat f'pazjenti b'titwil fl-intervall QT miksub jew konġenitali magħruf, jew b'fattur ta' riskju magħruf għal titwil fl-intervall QT inkluż bħal mard kardjovaskulari magħruf, żbilanċ sinifikanti fl-elettroliti (ipokalimja, ipomagnesimja), storja fil-familja ta' mewt kardijaka għall-għarrieda, bradikardija sinifikanti, jew l-użu konkomitanti ma' mediċini magħrufa li jtawlu l-intervall QT u/jew jinduċu torsades de pointes.
English: • Hydroxyzine has the potential to block hERG channels and other types of cardiac channels, resulting in a potential risk of QT interval prolongation and cardiac arrhythmia events.
Maltese: • Hydroxyzine għandu l-potenzjal li jimblokka l-kanali hERG u tipi oħrajn ta' kanali kardijaċi, u dan jirriżulta f'riskju potenzjali ta' titwil fl-intervall QT u avvenimenti ta' arritmija kardijaka.
English: This potential risk was confirmed by clinical and post-marketing data.
Maltese: Dan irriskju potenzjali kien ikkonfermat minn data klinika u ta' wara t-tqegħid fis-suq.
English: • The maximum dose in adults should be a total of 100 mg daily; in the elderly, if use cannot be avoided the maximum daily dose should be 50 mg.
Maltese: • Id-doża massima fl-adulti għandha tkun total ta' 100 mg kuljum; fl-anzjani, jekk l-użu ma jistax jiġi evitat, id-doża massima ta' kuljum għandha tkun 50 mg.
English: These medicines are available under various trade names including Atarax.
Maltese: Dawn il-mediċini huma disponibbli taħt diversi ismijiet kummerċjali inkluż Atarax.
English: • The maximum daily dose in children up to 40 kg in weight should be 2 mg/kg/day; children over 40 kg should be given the adult dose.
Maltese: • Id-doża massima ta' kuljum fit-tfal li jiżnu sa 40 kg għandha tkun 2 mg/kg/kuljum; it-tfal li jiżnu aktar minn 40 kg għandhom jingħataw id-doża tal-adulti.
English: The data showed that the risk did not differ between indications.
Maltese: Id-data wriet li r-riskju ma kienx differenti bejn l-indikazzjonijiet.
English: Having assessed the available evidence, including published studies and data from regular safety monitoring, the PRAC concluded that the risk did not differ between indications and that such events are most likely to occur in patients who have risk factors.
Maltese: Wara li ġiet ivvalutata l-evidenza disponibbli, inkluż listudji ppubblikati u d-data minn monitoraġġ tas-sigurtà regolari, il-PRAC ikkonkluda li r-riskju ma kienx differenti bejn l-indikazzjoni u li avvenimenti bħal dawn x'aktarx iseħħu f'pazjenti li għandhom fatturi ta' riskju.
English: The above risk minimisation measures were taken following an assessment of the available evidence, including published studies and data from regular safety monitoring.
Maltese: Il-miżuri ta' minimizzazzjoni tar-riskju ta' hawn fuq ittieħdu wara valutazzjoni tal-evidenza disponibbli, inkluż l-istudji ppubblikati u d-data minn monitoraġġ tas-sigurtà regolari.
English: • The dose in adults should not add up to more than a total of 100 mg a day.
Maltese: • Id-doża fl-adulti ma għandhiex tkun aktar minn total ta' 100 mg kuljum.
English: The CMDh is a regulatory body representing EU Member States plus Iceland, Liechtenstein and Norway, and is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: IsCMDh huwa korp regolatorju li jirrappreżenta lill-Istati Membri tal-UE flimkien mal-Iżlanda, ilLiechtenstein u n-Norveġja, u huwa responsabbli biex jiżgura standards ta' sigurtà armonizzati għallmediċini awtorizzati permezz ta' proċeduri nazzjonali fl-UE kollha.