FrancophonIA/ELRC3.0 huggingface dataset:
English: However in severe asthmatics, a 12 week study has shown that a dose of 640 micrograms/day (given 320 micrograms twice daily) has demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function (see section 5.1).
Maltese: Madankollu, f'pazjenti b'ażżma severa, studju li dam 12-il ġimgħa wera li doża ta' 640 mikrogramma/kuljum (mogħtija bħala 320 mikrogramma darbtejn kuljum) tnaqqas il-frekwenza ta' attakki eħrex, imma mingħajr l-ebda titjib fil-funzjoni tal-pulmun (ara sezzjoni 5.1).
English: - The proposed wording for Section 5.1 of the SPC at the end of the CMDh procedure has been amended to include more detail on Study M1 140.
Maltese: - Il-formulazzjoni ta' kliem proposta għat-Taqsima 5.1 tas-Sommarju tal-Karatteristiċi tal-Prodott fi tmiem tal-proċedura tas-CMDh ġiet emendata sabiex tinkludi iktar dettalji dwar l-Istudju M1 140.
English: If you have been taking steroid tablets before or during the use of Alvesco, the risk of side effects from the tablets may continue for a period of time.
Maltese: Jekk tkun qed tieħu pilloli sterojdi qabel jew waqt li tkun qed tuża Alvesco, ir-riskju ta' effetti sekondarji mill-pilloli jista' jkompli għal perijodu ta' żmien.
English: Alvesco 160 Inhaler 160 µg
Maltese: Inhaler 160 µg
English: Alvesco 160 Inhalator 160 µg
Maltese: Inhalator 160 µg
English: - The MAH has proposed an adequate study which would resolve the outstanding question on the long term use of 320 µg and 640 µg daily.
Maltese: - Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ippropona studju adegwat biex isolvi ilkwistjoni rikorrenti dwar l-użu fit-tul ta' 320 µg u 640 µg kuljum.
English: Ciclesonide exhibits low binding affinity to the glucocorticoid-receptor.
Maltese: Ciclesonide juri affinità baxxa ta' twaħħil mar-riċettur tal-glukokortikojde.
English: ANNEX
Maltese: MEMBRI
English: The monitoring of Methaemoglobin level
Maltese: Il-monitoraġġ tal-livell ta' Methaemoglobin
English: The monitoring of NO2 formation
Maltese: Il-monitoraġġ tal-formazzjoni ta' NO2
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch of the new indication, all Healthcare Professionals who are expected to use and/or prescribe INOmax as part of the treatment of peri- or post- operative pulmonary hypertension in adults and children in conjunction to heart surgery are provided with an Educational pack.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiżgura li, mat-tnedija talindikazzjoni l-ġdida, il-Professjonisti tal-Kura tas-Saħħa kollha li huma mistennija li jużaw u/jew li jippreskrivu INOmax bħala parti mill-kura ta' pressjoni pulmonari għolja qabel jew wara operazzjoni f'adulti u tfal flimkien ma' kirurġija tal-qalb, jiġu pprovduti b'pakkett Edukattiv.
English: The risk of rebound effect and the precautions to take when discontinuing the treatment The risk of abrupt discontinuation of Inomax therapy in the event of critical failure of the delivery system and how to prevent it
Maltese: Ir-riskju ta' waqfien f'daqqa ta' terapija ta' Inomax fil-każ ta' ħsara kritika tas-sistema talforniment u kif dan għandu jiġi impedut
English: The potential risk of bleeding and haemostasis disorders The potential risks if used in combination with other vasodilators which act on cGMP or cAMP
Maltese: Ir-riskji potenzjali jekk użati f'kombinazzjoni ma' vasodilaturi oħrajn li jaġixxu fuq cGMP jew cAMP
English: Educational material for Healthcare Professionals
Maltese: Materjal edukattiv għall-Professjonisti tal-Kura tas-Saħħa
English: The educational pack should contain the following: Summary of Product Characteristics and Patient Information Leaflet for INOmax
Maltese: Il-materjal edukattiv għandu jkun gwida li toqgħod fil-but li tinkludi informazzjoni dwar l-elementi ewlenin li ġejjin:
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented in their national territory: Prior to launch of the new indication of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder
Maltese: Qabel it-tnedija tal-indikazzjoni l-ġdida tal-prodott fl-Istat Membru, id-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq għandu jaqbel fuq il-kontenut u l-format tal-materjal edukattiv mal-awtorità kompetenti nazzjonali
English: ANNEX II
Maltese: Tabella 2
English: Benefit-Risk balance
Maltese: Bilanċ tal-Benefiċċju Riskju
English: Introduction
Maltese: Introduzzjoni
English: The CHMP's conclusions were arbitrary.
Maltese: Il-konklużjonijiet tas-CHMP kienu arbitrarji.
English: Gastric ethanol concentrations dropped rapidly after the consumption of alcohol by 70% in 10 min (Levitt et all, Am J Physiol Gastrointest Liver Physiol 273:951-957, 1997).
Maltese: Ilkonċentrazzjonijiet ta' etanol gastriku waqgħu malajr b'70% f'10 minuti wara l-konsum tal-alkoħol (Levitt et all, Am J Physiol Gastrointest Liver Physiol 273:951-957, 1997).
English: Clinical issues
Maltese: Kwistjonijiet kliniċi
English: for conventional-release products (NLT 75% dissolved active substance within 45 minutes).
Maltese: Eur għal prodotti b'rilaxx konvenzjonali (NLT 75% sustanza attiva mdewwba fi żmien 45 minuta).
English: On 18 September 2009, the European Commission triggered a referral under Article 31 of Directive 2001/83/EC, as amended.
Maltese: Fit-18 ta' Settembru 2009, il-Kummissjoni Ewropea tat bidu għal referenza skont l-Artikolu 31 tadDirettiva 2001/83/KE, kif emendata.
English: • The Committee considered all the available data submitted by the MAHs,
Maltese: • Il-Kumitat qies id-dejta kollha disponibbli ppreżentata mill-MAHs,
English: Whereas
Maltese: ç
English: The MAH expressed the view that:
Maltese: Il-MAH esprima l-fehma li:
English: This effect is known as ‘dose-dumping'.
Maltese: Dan l-effett huwa magħruf bħala ‘dumping tad-doża'.
English: The MAH mentioned in his grounds for re-examination a paper by Smith at al (In vitro dissolution of oral modified-release tablets and capsules in ethanolic media, International Journal of Pharmaceutics 398 (2010) 93-96) to illustrate that formulations should not be assumed to be unaffected by alcohol without data being evaluated.
Maltese: Fir-raġunijiet tiegħu għall-evalwazzjoni mill-ġdid il-MAH semma dokument ta' Smith at al (In vitro dissolution of oral modified-release tablets and capsules in ethanolic media (Id-dissoluzzjoni in vitro ta' pilloli u kapsuli orali ta' rilaxx modifikat f'mezzi etanoliċi), International Journal of Pharmaceutics 398 (2010) 93-96) sabiex jispjega li m'għandux ikun preżunt li l-formulazzjonijiet m'humiex affettwati millalkoħol mingħajr ma tkun evalwata d-dejta.
English: The results of the only study with a morphine product (ethylcellulose N-50, methacrylic acid copolymer type C, polyethylene glycol 6000 and diethyl phthalate formulation) indicate that a relatively high quantity of alcohol has almost no effect in vivo.
Maltese: Ir-riżultati tal-uniku studju bi prodott tal-morfina (formolazzjoni ta' ethylcellulose N-50, methacrylic o copolymer tip C, polyethylene glycol 6000 u diethyl phthalate) jindikaw li kwantità relattivament għolja ta' alkoħol kważi ma għandha ebda effett in vivo.
English: A similar dissolution study from 2007 however, showed that at 60 minutes the dissolution rate of the reference product (considered by the MAH to be a safe product) in the absence of alcohol was actually higher that the dissolution rate of the competing product presented when exposed to 20% alcohol.
Maltese: Madankollu, studju simili dwar id-dissoluzzjoni mill-2007, wera li fis-60 minuta r-rata ta' dissoluzzjoni tal-prodott ta' referenza (li l-MAH jikkunsidra bħala prodott sigur) fin-nuqqas tal-alkoħol kienet fil-fatt ogħla mir-rata ta' dissoluzzjoni li l-prodott kompetitur kellu meta kien espost għal 20% alkoħol.
English: Another study conducted with a hydromorphone formulation based on cellulose acetate 398-10 and Macrogol 3350 formulation confirmed the conclusions of the in vitro studies that the effect of coadministered alcohol on PK parameters is rather limited.
Maltese: Studju ieħor imwettaq b'formolazzjoni ta' hydromorphone ibbażat fuq formolazzjoni ta' cellulose acetate 398-10 u Macrogol 3350 ikkonferma l-konklużjonijiet tal-istudji in vitro li l-effett ta' alkoħol koamministrat fuq il-parametri PK huwa wieħed pjuttost limitat.
English: With food the gastric emptying of alcohol is delayed, but still significant (50-60% in 1 hour, Levitt, 1997, and Cortot et al, Digestive Diseases and Sciences 1986; 31:343-48).
Maltese: Mal-ikel it-tbattil gastriku tal-alkoħol idum aktar, iżda xorta huwa sinifikanti (50-60% f'siegħa, Levitt, 1997, u Cortot et al, Digestive Diseases and Sciences (Mard u Xjenzi tad-Diġestjoni) 1986;
English: Dissolution data was submitted for two different controlled release systems of hydromorphone, four different controlled release systems of oxycodone, and seven different controlled release systems containing morphine.
Maltese: Dejta ta' dissoluzzjoni ġiet sottomessa għal żewġ sistemi ta' rilaxx ikkontrollat differenti ta' hydromorphone, erba' sistemi ta' rilaxx ikkontrollat differenti ta' oxycodone, u seba' sistemi ta' rilaxx ikkontrollat differenti ta' morfina.
English: The in vitro data showed a release of 80% of the drug within 15 minutes in 20% of alcohol solution.
Maltese: Iddejta in vitro uriet rilaxx ta' 80% tal-mediċina fi żmien 15-il minuta f'20% ta' soluzzjoni tal-alkoħol.
English: This further illustrates the limitations of the data presented.
Maltese: Dan ikompli jispjega l-limitazzjonijiet tad-dejta ppreżentata.
English: This is clearly demonstrated by the existing data for one specific product for which the in vitro interaction is significant but where the pharmacokinetic parameters did not differ significantly among subjects taking the product with water or with alcohol (ethylcellulose N-50, methacrylic acid copolymer type C, polyethylene glycol 6000 and diethyl phthalate product).
Maltese: Dan jintwera ċar mid-dejta eżistenti għal prodott partikolari li l-interazzjoni in vitro tiegħu hija sinifikanti iżda l-parametri farmakokinetiċi tiegħu ma kienux daqstant differenti fost issuġġetti li ħadu l-prodott mal-ilma jew mal-alkoħol (prodott ethylcellulose N-50, methacrylic acid copolymer tat-tip C, polyethylene glycol 6000 u diethyl phthalate).
English: • The Committee took the view that modified-release oral opioid products in the level III of the WHO scale for the management of pain containing a polymethacrylate-triethylcitrate coating as modified-release mechanism are harmful under the normal conditions of use in accordance with article 116 of Directive 2001/83/EC, as amended.
Maltese: • Il-Kumitat ħa l-opinjoni li prodotti opjojdi orali b'rilaxx modifikat fil-livell III tal-iskala WHO għallġestjoni tal-uġigħ li fihom kisja ta' polymethacrylate-triethylcitrate bħala mekkaniżmu ta' rilaxx modifikat huma ta' ħsara taħt il-kundizzjonijiet normali tal-użu skont l-Artikolu 116 tad-Direttiva 2001/83/KE, kif emendat.
English: For most of the products assessed, only in vitro data was submitted.
Maltese: Għal ħafna mill-prodotti vvalutati, ġiet sottomessa biss dejta in vitro.
English: It is clearly stated in the Opinion that 50% of the formulations were found to be affected by alcohol in vitro.
Maltese: Huwa ddikjarat b'mod ċar fl-Opinjoni li 50% tal-formulazzjonijiet instabu li huma affettwati mill-alkoħol in vitro.
English: In vivo studies conducted with a hydromorphone formulation based on ammonio methacrylate copolymer type B (Eudragit RS) confirmed the existing in vitro data suggesting that alcohol affects the formulation.
Maltese: Studji in vivo mwettqa b'formolazzjoni ta' hydromorphone ibbażati fuq ammonio methacrylate copolymer tip B (Eudragit RS) ikkonfermaw id-dejta in vitro eżistenti li tissuġġerixxi li l-alkoħol jaffettwa l-formolazzjoni.
English: A product containing hydromorphone and a prolonged release system consisting of ammonio methacrylate co-polymer type B (Eudragit RS) also suffered a significant effect of high concentrations of alcohol on in vitro dissolution.
Maltese: Prodott li fih hydromorphone u sistema ta' rilaxx prolongat li tikkonsisti minn ammonio methacrylate co-polymer tip B (Eudragit RS) sofriet ukoll minn effett sinifikanti ta' konċentrazzjonijiet għoljin ta' alkoħol mad-dissoluzzjoni in vitro.
English: Quality issues
Maltese: Kwistjonijiet ta' kwalità
English: Concurrent depression and pain have a much greater impact than either disorder alone and, in patients with pain, depression is associated to more pain sites, greater pain intensity, longer duration of pain, and greater likelihood of poor treatment response (Bair, J et al., Psychosom Med. 2008 October; 70(8): 890-897).
Maltese: Dipressjoni u uġigħ fl-istess ħin għandhom impatt ferm ikbar minn jew disturb waħdu u, f'pazjenti b'uġigħ, id-dipressjoni hija assoċjata ma' aktar siti ta' uġigħ, aktar intensità ta' uġigħ, dewmien itwal tal-uġigħ, u probabbiltà ikbar ta' rispons ta' kura dgħajjef (Bair, J et al., Psychosom Med. 2008 Ottubru;
English: According to the data on a competitor product presented by the MAH requesting re-examination, this product starts to exhibit accelerated release of the active substance after approximately 30 min of exposition to alcohol, and is claimed to release 76.5% of the oxycodone dose within one hour of exposure to concentrations of alcohol around 24%.
Maltese: Skont id-dejta dwar prodott kompetitur ippreżentata mill-MAH li talab l-evalwazzjoni mill-ġdid, dan il-prodott jibda juri rilaxx mgħaġġel tas-sustanza attiva wara madwar 30 minuta mill-espożizzjoni għall-alkoħol, u huwa mifhum li jirrilaxxa 76.5% tad-doża ta' oxycodone fi żmien siegħa mill-espożizzjoni għal konċentrazzjonijiet ta' madwar 24% alkoħol.
English: Level III of the WHO scale includes fentanyl, hydromorphone, morphine and oxycodone, however no oral modified-release products containing fentanyl are currently authorised in the EU, as due to a marked first pass effect, oral administration of fentanyl is not feasible.
Maltese: Livell III tal-iskala WHO jinkludi fentanyl, hydromorphone, morfina u oxycodone, madankollu ebda prodott b'rilaxx modifikat orali li fih fentanyl ma huwa awtorizzat fil-preżent fl-UE, minħabba li b'effett talewwel użu sinfikanti, amminstrazzjoni orali ta' fentanyl mhijiex fattibbli.
English: This is demonstrated by measurements of gastric-duodenal ethanol levels after consumption of alcohol in healthy volunteers.
Maltese: Dan jintwera permezz tal-kejl tal-livelli gastriċi-duwodenali ta' etanol wara l-konsum tal-alkoħol f'voluntiera b'saħħithom.
English: Following the CHMP Opinion of 22 July 2010, one MAH submitted detailed grounds for the re-examination of the opinion.
Maltese: Wara l-opinjoni tas-CHMP tat-22 ta' Lulju 2010, MAH wieħed ippreżenta raġunijiet dettaljati għallevalwazzjoni mill-ġdid tal-opinjoni.
English: However, a significant percentage of the patients with chronic pain who uses opioids still reports high alcohol intake (10.8%) and binge drinking at least once a month (22.3%), despite existing warnings.
Maltese: 8%) u xorb ta' ammont kbir ta' alkoħol f'daqqa għallinqas darba fix-xahar (22.3%), minkejja twissijiet eżistenti.
English: It is of note that, in the data presented by the MAH for this competitor product, the most pronounced effect of alcohol is not at the highest alcohol concentrations tested (40%), but between 28%-32%.
Maltese: Ta' min jinnota li, fid-dejta li ppreżenta l-MAH dwar dan il-prodott kompetitur, l-aktar effett qawwi talalkoħol m'huwiex fl-ogħla konċentrazzjonijiet ta' alkoħol ittestjati (40%), iżda bejn 28%-32%.
English: The CHMP having assessed all the detailed grounds for re-examination and argumentation presented by the MAH and having considered the views of the Rapporteurs, the scientific discussion within the Committee and the conclusions of the ad hoc expert group as well as the concerns raised by the MAH in this respect, concluded that products with a polymethacrylate-triethylcitrate coating are harmful under the normal conditions of use and that, for the remaining products, the Product Information should be amended to include a warning and recommendation for avoiding concomitant use with alcohol.
Maltese: Wara li evalwa r-raġunijiet dettaljati kollha għall-evalwazzjoni mill-ġdid u l-argumenti ppreżentat millMAH u wara li kkunsidra l-fehmiet tar-Rapporteurs, id-diskussjoni xjentifika fi ħdan il-Kumitat u lkonklużjonijiet tal-grupp ta' esperti ad hoc kif ukoll it-tħassib li qajjem il-MAH f'dan ir-rigward, is-CHMP ikkonkluda li prodotti b'kisja ta' polymethacrylate-triethylcitrate huma ta' ħsara f'kundizzjonijiet normali ta' użu u li, għall-prodotti l-oħrajn, l-Informazzjoni dwar il-Prodott għandha tkun emendata b'mod li tinkludi twissija u rakkomandazzjoni sabiex jiġi evitat l-użu konkomitanti mal-alkoħol.
English: Overall summary of the scientific evaluation of modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications) (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti opjojdi b'rilaxx modifikat fil-livell III taliskala WHO għall-ġestjoni tal-uġigħ (uġigħ sostnut intens reżistenti għall-medikazzjonijiet preċedenti) (ara l-Anness I)
English: The dissolution profile of this product (80% dissolved substance within 15 min in 20% alcohol) is beyond the limit of the Ph. Eur.
Maltese: Il-profil ta' dissoluzzjoni ta' dan il-prodott (80% sustanza mdewba fi żmien 15-il min f'20% alkoħol) huwa 'l hinn mil-limitu tal-Ph.
English: For all other strong-opioid modified release oral products in the European market (formulations not containing polymethacrylate-triethylcitrate), no significant risk of dose-dumping due to alcohol use was identified.
Maltese: Għall-prodotti opjojdi orali b'saħħithom b'rilaxx modifikat l-oħrajn kollha fis-suq Ewropew (formolazzjonijiet li ma fihomx polymethacrylate-triethylcitrate), ma ġie identifikat ebda riskju sinifikanti ta' dumping tad-doża dovut għall-alkoħol.
English: Having assessed the detailed grounds for re-examination provided by the MAH, the rapporteurs assessment reports, the conclusions from the ad hoc expert meeting together with the MAH's expressed concerns on the conclusions of the ad hoc expert meeting and all the information submitted during the referral procedure, the CHMP discussed each one of the grounds submitted:
Maltese: Wara li evalwa r-raġunijiet dettaljati għall-evalwazzjoni mill-ġdid li ppreżenta l-MAH, ir-rapporti ta' valutazzjoni tar-rapporteurs, il-konklużjonijiet li ħarġu mil-laqgħa tal-esperti ad hoc flimkien mattħassib li esprima l-MAH dwar il-konklużjonijiet tal-laqgħa tal-esperti ad hoc u l-informazzjoni kollha sottomessa waqt il-proċedura ta' referenza, is-CHMP iddiskuta kull raġuni ppreżentata:
English: • In addition, the Committee considered that the dissolution profile of products containing a polymethacrylate-triethylcitrate coating as modified-release mechanism is significantly affected in the presence of alcohol, leading to an uncontrolled rapid release of the majority of the active substance, and therefore the product exhibits a significant interaction with alcohol with potentially significant clinical effects (e.g. respiratory depression and death),
Maltese: • Barra minn hekk, il-Kumitat qies li l-profil ta' dissoluzzjoni ta' prodotti li fihom kisja ta' polymethacrylate-triethylcitrate bħala mekkaniżmu ta' rilaxx modifikat huwa affettwat b'mod sinifikanti fil-preżenza tal-alkoħol, u dan iwassal għal rilaxx rapidu mhux ikkontrollat talmaġġoranza tas-sustanzi attivi, u għaldaqstant il-prodott jesebixxi interazzjoni sinifikanti malalkoħol b'effetti kliniċi potenzjalment sinifikanti (eż. dipressjoni respiratorja u mewt),
English: In a limited number of cases, the MAH has also presented the results of in vivo studies and/or a review of adverse event reports which may have been related to the concomitant use of alcohol.
Maltese: F'għadd ta' każijiet limitati, ilMAH ippreżenta wkoll ir-riżultati ta' studji in vivo u/jew reviżjoni ta' rapporti ta' avvenimenti avversi li setgħu kienu relattati mal-użu konkomittanti tal-alkoħol.
English: Therefore, the European Commission requested the CHMP to give its opinion on whether the marketing authorisations for authorised modified-release oral medicinal products of the WHO level III scale for the management of pain (intense sustained pain resistant to previous medications) (containing morphine, oxycodone, fentanyl and hydromorphone) should be maintained, varied, suspended or withdrawn.
Maltese: Għaldaqstant, il-Kummissjoni Ewropea talbet lis-CHMP sabiex jagħti l-opinjoni tiegħu dwar jekk lawtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali orali b'rilaxx modifikat awtorizzati taliskala ta' livell III tal-WHO għall-ġestjoni tal-uġigħ (uġigħ sostnut intens reżistenti għal medikazzjonijiet preċedenti) (li fihom morfina, oxycodone, fentanyl u hydromorphone) għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew jiġu rtirati.
English: The issue of additional risk to patients was addressed by CHMP in its initial opinion, and as a consequence a recommendation was adopted to suspend and reformulate the formulations where the interaction was of such magnitude that the products essentially resemble an immediate release formulation (while containing the opioid dose appropriate for a modified release formulation).
Maltese: Is-CHMP kien indirizza l-kwistjoni ta' riskju addizzjonali għall-pazjenti fl-opinjoni inizjali tiegħu, u bħala konsegwenza ġiet adottata rakkomandazzjoni sabiex jiġu sospiżi u fformulati mill-ġdid ilformulazzjonijiet fejn l-interazzjoni kienet ta' tali kobor li l-prodotti jixbhu essenzjalment formulazzjoni ta' rilaxx immedjat (filwaqt li jkun fihom id-doża ta' opjojdi meħtieġa għal formulazzjoni ta' rilaxx modifikat).
English: The advice of the QWP was that formulations should, if possible, be developed such that a physicochemical incompatibility with alcohol is avoided.
Maltese: Il-parir tal-QWP kien li l-formulazzjonijiet għandhom, jekk huwa possibbli, ikunu żviluppati b'mod li jiġi evitat nuqqas ta' kompatibbiltà fiżjokimika mal-alkoħol.
English: While it may be argued that patients may use less alcohol as a self-medication strategy if they are sufficiently treated with analgesics like opioids, the results of a recently published Danish Health survey (Ekholm et al. Eur J Pain 2009; 13: 606-12) reveal a different pattern of behavior.
Maltese: Eur J Pain 2009; 13: 606-12) juru stil ta' imġiba differenti.
English: The association between pain and drinking was evaluated by Brennan et al in a cohort of 401 elderly with different drinking behavior (Brennan, Addiction.
Maltese: L-assoċjazzjoni bejn l-uġigħ u x-xorb ġiet evalwata minn Brennan et al fi studju koorti ta' 401 anzjan b'imġiba differenti fir-rigward tax-xorb (Brennan, Addiction. 2005; 100(6): 777-86).
English: In its initial Opinion, the CHMP did not conclude that the formulations analysed were unaffected by alcohol.
Maltese: Fl-Opinjoni inizjali tiegħu, is-CHMP ma kkonkludiex li l-formulazzjonijiet analizzati ma kienux affettwati mill-alkoħol.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, as amended for modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications),
Maltese: • Il-Kumitat qies il-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata għal prodotti opjojdi orali b'rilaxx modifikat fil-livell III tal-iskala
English: It is well known that food can have an effect on the pharmacokinetic parameters of medicinal products.
Maltese: Huwa magħruf sew li l-ikel jista' jkollu effett fuq il-parametri farmakokinetiċi ta' prodotti mediċinali.
English: Where not possible, the QWP recommended the inclusion of differential wording in the Product Information.
Maltese: Fejn m'huwiex possibbli, il-QWP irrakkomanda l-inklużjoni ta' kliem differenzjali fl-Informazzjoni dwar il-Prodott.