FrancophonIA/ELRC3.0 huggingface dataset:
English: The manufacturer can be identified by the batch number printed on the slip of the carton and on the label: - If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Maltese: - Jekk it-tieni u t-tielet karattri huma S6,P5,K7 R7, VG, FG jew ZF, il-manifattur huwa Novo
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH)
English: Actrapid contains less than 1 mmol sodium (23 mg) per dose, i.e. Actrapid is essentially ‘sodiumfree'.
Maltese: Actrapid fih inqas minn mmol 1 ta' sodium (23 mg) għal kull doża, i.e Actrapid huwa essenzjalment ‘bla sodium'.
English: 1 ml solution contains 100 IU insulin human (equivalent to 3.5 mg),
Maltese: UI ta' insulina umana (ekwivalenti għal 3.5 mg),
English: 1 vial contains 10 ml equivalent to 1,000 international units.
Maltese: Kunjett fih 10 ml ekwivalenti għal 1,000 unità internazzjonali.
English: Other medicines and Actrapid
Maltese: Mediċini oħra u Actrapid
English: Solution for injection Multipack: 5 packs of 1 x 10 ml vial
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni Pakkett multiplu: 5 pakketti ta' kunjett 1 x 10 ml
English: EU/1/02/230/016 5 packs of 1 x 10 ml vial
Maltese: EU/1/02/230/016 5 pakketti ta' kunjett 1 x 10 ml
English: The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
Maltese: Il-konċentrazzjoni massima fil-plażma tintlaħaq fi żmien 1.5-2.5 sigħat wara l-għoti minn taħt il-ġilda.
English: Pregnancy
Maltese: Isselezzjonati
English: The following substances may increase the patient's insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Maltese: Kontraċettivi orali, tijażidi, glukokortikojdi, ormoni tat-tirojde, simpatomimetiċi, l-ormon tat-tikbir u danazol.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: Date of first authorisation: 07 October 2002
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 07 Ottubru 2002
English: Pull off the pen cap (see A).
Maltese: Neħħi l-għatu tal-pinna (ara A)
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of solution in a pre-filled multidose disposable pen made of polypropylene.
Maltese: Skartoċċ (tal-ħġieġ ta' tip 1) bi planġer (bromobutyl) u għatu tal-lastku (bromobutyl/polyisoprene) li fih soluzzjoni ta' 3 ml ġo pinna mimlija għal-lest li tagħti dożi multipli u li tintrema wara l-użu u magħmula mill-polypropylene.
English: Actrapid vial (40 international units/ml)/Actrapid vial (100 international units/ml) Intravenous use
Maltese: Actrapid kunjett (40 unità internazzjonali/ml)/Actrapid kunjett (100 unità internazzjonali/ml)
English: Each vial contains 1,000 IU of human insulin in 10 ml solution for injection.
Maltese: Kull kunjett fih 1,000 UI ta' insulina umana f'10 ml ta' soluzzjoni għall-injezzjoni.
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of solution.
Maltese: Skartoċċ (tal-ħġieġ ta'tip 1) bi planġer (bromobutyl) u għatu tal-lastku (bromobutyl/polyisoprene) u li fih soluzzjoni ta' 3 ml.
English: • Drink alcohol, see Actrapid with alcohol in section 2.
Maltese: • Tixrob l-alkoħol ara Actrapid mal-alkoħol f'sezzjoni 2
English: Actrapid Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: Actrapid Penfill hu magħmul biex jintuża ma' sistemi ta' għoti ta' insulina NovoNordisk u labar NovoFine jew NovoTwist.
English: PC: SN:
Maltese: Waqt l-użu:.
English: Solution for injection 1 vial of 10 ml.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni kunjett 1 x 10 ml.
English: ► Actrapid Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: ► L-iskrataċ ta' Actrapid Penfill huma magħmula biex jintużaw mas-sistemi tal-għoti tal-insulina Novo Nordisk u mal-labar NovoFine jew NovoTwist.
English: Actrapid vial (40 international units/ml)
Maltese: Actrapid f'kunjett (40 unità internazzjonali/ml)
English: Actrapid InnoLet EU/1/02/230/010 EU/1/02/230/011 EU/1/02/230/012
Maltese: EU/1/02/230/011 EU/1/02/230/012
English: You can carry it with you and keep it at room temperature (below 25ºC) for up to 6 weeks.
Maltese: Tista' ġġorru miegħek u żżommu f'temperatura ta' kamra (taħt 25°C) sa mhux iżjed minn 6 ġimgħat.
English: Actrapid vial (100 international units/ml)
Maltese: Actrapid f'kunjett (100 unità internazzjonali/ml)
English: At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur.
Maltese: Fil-bidu tal-kura bl-insulina, jistgħu jseħħu anomaliji ta' rifrazzjoni, edima u reazzjonijiet fis-sit tal injezzjoni (uġigħ, ħmura, urtikarja, infjammazzjoni, tbenġil, nefħa u ħakk fis-sit tal-injezzjoni).
English: EU/1/02/230/001 1 vial of 10 ml EU/1/02/230/002 5 vials of 10 ml
Maltese: EU/1/02/230/001 kunjett 1 ta' 10 ml EU/1/02/230/002 5 kunjetti ta' 10 ml
English: EU/1/02/230/003 1 vial of 10 ml EU/1/02/230/004 5 vials of 10 ml
Maltese: EU/1/02/230/003 kunjett 1 ta' 10 ml EU/1/02/230/004 5 kunjetti ta' 10 ml
English: Actrapid Penfill 100 international units/ml solution for injection in cartridge.
Maltese: Actrapid Penfill 100 unità internazzjonali/ml soluzzjoni għall-injezzjoni f'skartoċċ.
English: The data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults.
Maltese: L-informazzjoni hi limitata iżda tissuġġerixxi li l-profil farmakokinetiku fit-tfal u fl-adolexxenti jista' jkun simili għal dak fl-adulti.
English: Actrapid FlexPen is a pre-filled disposable pen containing human insulin.
Maltese: Kif timmaniġġja Actrapid FlexPen Actrapid FlexPen hija pinna mimlija għal-lest li tintuża darba biss u li fiha insulina umana.
English: - If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production
Maltese: Jekk it-tieni u t-tielet karattri huma H7 jew T6, il-manifattur huwa Novo Nordisk Production
English: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulty in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life threatening.
Maltese: Li jseħħu reazzjonijiet ta' sensittività eċċessiva ġeneralizzata (li jinkludu raxx tal-ġilda ġeneralizzat, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultajiet fit-teħid tan-nifs, tħabbit mgħaġġel tal-qalb u tnaqqis fil-pressjoni tad-demm) huwa rari iżda jistgħu jkunu ta' periklu għall ħajja Ipogliċemija
English: - If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
Maltese: - Jekk it-tieni u t-tielet karattri huma S6 jew ZF il-manifattur huwa Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Id-Danimarka.
English: How to store Actrapid
Maltese: Tużax Actrapid
English: Actrapid FlexPen 100 IU/ml Solution for injection Insulin human SC
Maltese: Actrapid FlexPen 100 UI/ml Soluzzjoni għall-injezzjoni Insulina umana
English: Actrapid 40 IU/ml Solution for injection Insulin human
Maltese: Actrapid 40 UI/ml Soluzzjoni għall-injezzjoni Insulina umana
English: Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
Maltese: Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Id-Danimarka.
English: You can carry it with you and keep it at room temperature (below 25ºC) for up to 4 weeks.
Maltese: Tista' ġġorru miegħek u żżommu f'temperatura ta' kamra (taħt 25°C) sa mhux iżjed minn 4 ġimgħat.
English: Actrapid with alcohol
Maltese: Actrapid mal-alkoħol
English: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Maltese: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Id--Danimarka
English: Actrapid Penfill 100 IU/ml Solution for injection Insulin human SC
Maltese: Actrapid Penfill 100 UI/ml Soluzzjoni għall-injezzjoni Insulina umana
English: Package leaflet: Information for the user Actrapid Penfill 100 IU/ml (international units/ml) solution for injection in cartridge human insulin
Maltese: Informazzjoni għall-utent Actrapid Penfill 100 UI/ml (unità internazzjonali/ml) soluzzjoni għall-injezzjoni f'skartoċċ insulina umana
English: • Always make sure that a drop appears at the needle tip before injection (picture 1B).
Maltese: • Dejjem aċċerta ruħek li tidher qatra fit-tarf tal-labra qabel l-injezzjoni (stampa 1B).
English: Each cartridge contains 300 IU of human insulin in 3 ml solution for injection.
Maltese: Kull skartoċċ fih 300 UI ta' insulin umana f'3 ml ta' soluzzjoni għall-injezzjoni.
English: Actrapid is indicated for treatment of diabetes mellitus.
Maltese: Actrapid hu indikat għall-kura tad-dijabete mellitus.
English: Actrapid 100 IU/ml Solution for injection Insulin human
Maltese: Actrapid 100 UI/ml Soluzzjoni għall-injezzjoni Insulina umana
English: • Screw the needle straight and tightly onto your InnoLet (picture 1A).
Maltese: • Waħħal il-labra dritta u soda fuq l-InnoLet tiegħek billi tissikka l-kamin (stampa 1A).
English: Actrapid FlexPen EU/1/02/230/013 EU/1/02/230/014 EU/1/02/230/015
Maltese: EU/1/02/230/013 EU/1/02/230/014
English: Actrapid FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit.
Maltese: Il-FlexPen hi magħmula biex tintuża mal-labar NovoFine jew NovoTwist li jintużaw darba biss u li għandhom tul ta' mhux iżjed minn 8 mm.
English: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark Manufacturer
Maltese: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Id-Danimarka
English: 1 ml solution contains 40 IU insulin human (equivalent to 1.4 mg),
Maltese: (ekwivalenti għal 1.4 mg),
English: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Maltese: Indeboliment renali u epatiku L-indeboliment renali jew epatiku jista' jnaqqas il-ħtieġa tal-pazjent għall-insulina.
English: The terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of insulin from plasma (insulin in the blood stream has a t½ of a few minutes).
Maltese: Għalhekk ilhalf-life terminali (t½) hi kejl ta' l-assorbiment u mhux ta' l-eliminazzjoni ta' l-insulina mill-plażma per se (l-insulina fiċ-ċirkolazzjoni tad-demm għandha t½ ta' ftit minuti).
English: Actrapid vials are for use with insulin syringes with a corresponding unit scale.
Maltese: Il-kunjetti ta' Actrapid huma għall-użu ma' siringi tal-insulina bi skala korrispondenti ta' unitajiet.
English: Package leaflet: Information for the user Actrapid 40 IU/ml (international units/ml) solution for injection in vial human insulin
Maltese: Informazzjoni għall-utent Actrapid 40 UI/ml (unità internazzjonali/ml) soluzzjoni għall-injezzjoni f'kunjett insulina umana
English: Dose selector
Maltese: TA' EĊĊIPJENTI
English: EU/1/02/230/004
Maltese: EU/1/02/230/003 EU/1/02/230/004
English: Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Maltese: Retinopatija dijabetika (mard tal-għajnejn relatata mad-dijabete li tista' twassal għat-telf tal-vista):
English: Actrapid Penfill EU/1/02/230/005 EU/1/02/230/006 EU/1/02/230/007
Maltese: EU/1/02/230/006 EU/1/02/230/007
English: Actrapid 40 international units/ml solution for injection in vial.
Maltese: Actrapid 40 unità internazzjonali/ml soluzzjoni għall-injezzjoni f'kunjett.
English: Insulin cartridge
Maltese: ġewwa tallabra
English: They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
Maltese: Dan inaqqas ir-riskju ta' kontaminazzjoni, infezzjoni, tnixxija tal-insulina, labar misduda u għoti ta' doża mhux preċiża.
English: Package leaflet: Information for the user Actrapid InnoLet 100 IU/ml (international units/ml) solution for injection in pre-filled pen human insulin
Maltese: Informazzjoni għall-utent Actrapid 100 UI/ml (unità internazzjonali/ml) soluzzjoni għall-injezzjoni f'kunjett insulina umana
English: Use in special patient groups
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI 5
English: Actrapid 100 international units/ml solution for injection in vial.
Maltese: Actrapid 100 unità internazzjonali/ml soluzzjoni għall-injezzjoni f'kunjett.
English: Uncommon - Urticaria, rash Very rare - Anaphylactic reactions*
Maltese: Rari ħafna - Reazzjonijiet anafilattiċi*
English: Insulins and analogues for injection, fast-acting, insulin (human).
Maltese: Mediċini użati fid-dijabete.Insulini u analogi għall-injezzjoni, insulina
English: Solution for injection 1 vial of 10 ml 5 vials of 10 ml
Maltese: Kunjett 1 ta' 10 ml
English: Each prefilled pen contains 300 IU of human insulin in 3 ml solution for injection.
Maltese: Kull pinna mimlija għal-lest fiha 300 UI ta' insulin umana f'3 ml ta' soluzzjoni għall-injezzjoni.
English: EU/1/02/230/017 5 packs of 1 x 10 ml vial
Maltese: EU/1/02/230/015 10 pinen ta' 3 ml
English: • Thiazides (used to treat high blood pressure or excessive fluid retention)
Maltese: • Thiazides ( użati fil-kura ta' pressjoni għolja fid-demm jew żamma eċċessiva ta' fluwidi)
English: The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Maltese: Meta l-pazjenti jaqilbu minn prodotti mediċinali oħra ta' insulina, jista' jkun hemm bżonn ta' aġġustament fid-doża ta' Actrapid u fid-doża tal-insulina bażilari.
English: Denmark Name and address of the manufacturers responsible for batch release
Maltese: Id-Danimarka Novo Nordisk Production SAS
English: Actrapid is presented as a solution for injection.
Maltese: Actrapid jista' jintuża waqt it-tqala.
English: The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
Maltese: Il-manifattur jista' jiġi identifikat permezz tan-numru tal-lott ipprintjat fuq il-kartuna u fuq it-tikketta:
English: Big outer needle cap
Maltese: UŻATI JEW SKART MINN DAWN
English: Package leaflet: Information for the user Actrapid FlexPen 100 IU/ml (international units/ml) solution for injection in pre-filled pen human insulin
Maltese: Informazzjoni għall-utent Actrapid FlexPen 100 UI/ml (unità internazzjonali/ml) soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest insulina umana
English: Actrapid InnoLet is a pre-filled disposable pen containing human insulin.
Maltese: Kif timmaniġġja Actrapid InnoLet Actrapid InnoLet hija pinna mimlija għal-lest li tintuża darba biss u li fiha insulina umana.
English: 30 March 2012
Maltese: 30 ta' Marzu 2012
English: Outcome of a procedure under Article 107 of Directive 2001/83/EC
Maltese: Riżultat ta' proċedura taħt l-Artikolu 107 tad-Direttiva 2001/83/KE
English: Meprobamate is a sedative medicine used to treat the symptoms of anxiety and related conditions, including anxiety states, alcohol withdrawal, migraine attacks, digestive disorders, muscle tension or cramps and insomnia.
Maltese: Il-meprobamatu hija mediċina sedattiva użata fil-kura tas-sintomi tal-ansjetà u ta' kundizzjonijiet relatati, inklużi stati ta' ansjetà, irtirar mill-alkoħol, attakki ta' emigranja, disturbi diġestivi, tensjoni jew bugħawwieġ fil-muskoli u insonnja.
English: Why was meprobamate reviewed?
Maltese: Għalxiex ġiet riveduta l-meprobamatu?
English: These medicines are currently authorised in France, the Netherlands, Finland, Hungary, Italy, Romania and the United Kingdom, as well as Iceland and Norway, under the invented name Equanil and other trade names.
Maltese: Bħalissa dawn il-mediċini huma awtorizzati fi Franza, fil-Pajjiżi l-Baxxi, fil-Finlandja, fl-Ungerija, fl-Italja, fir-Rumanija u fir-Renju Unit, kif ukoll fl-Islanda u fin-Norveġja, bl-isem kummerċjali Equanil u ismijiet kummerċjali oħrajn.
English: The CHMP considered the benefit-risk assessment carried out by the French medicines agency for meprobamate-containing medicines marketed in France, covering data from the period 2009 to 2011.
Maltese: Is-CHMP qies il-valutazzjoni tar-rapport benefiċċju/riskju li saret mill-Aġenzija Franċiża għall-mediċini tal-mediċini li fihom il-meprobamatu u li jinbiegħu fi Franza, u li tkopri dejta mill-perjodu 2009 sal2011.
English: Measures to minimise the risks with meprobamate had already been taken in France.
Maltese: Fi Franza diġà ttieħdu miżuri li jnaqqsu r-riskji tal-meprobamatu.
English: The CHMP noted that there was a risk of serious and potentially fatal side effects in patients taking meprobamate-containing medicines under normal conditions of use, including coma.
Maltese: Is-CHMP innota li kien hemm riskju li jiżviluppaw effetti sekondarji serji u possibbilment fatali f'pazjenti li jieħdu mediċini li fihom il-meprobamatu skont il-kundizzjonijiet normali tal-użu, inkluża koma.
English: Oral meprobamate-containing medicines have been authorised in a number of EU Member States for several decades via national procedures.
Maltese: Il-mediċini orali li fihom il-meprobamatu ilhom awtorizzati f'għadd ta' Stati Membri tal-UE tul diversi għexieren ta' snin permezz ta' proċeduri nazzjonali.
English: Finally, the CHMP considered that there was limited data on the benefits of meprobamate.
Maltese: Fl-aħħar nett, isCHMP qies li kien hemm dejta limitata dwar il-benefiċċji tal-meprobamatu.
English: The Committee also considered information requested from the companies that market meprobamatecontaining medicines in the EU.
Maltese: Il-Kumitat qies ukoll informazzjoni mitluba mill-kumpaniji li jbiegħu l-mediċini li fihom ilmeprobamatu fl-UE.
English: The Committee recommended that the suspension should be implemented gradually to avoid the risk of severe withdrawal symptoms in patients stopping treatment abruptly.
Maltese: Il-Kumitat irrakkomanda li ssospensjoni għandha tiġi implimentata bil-mod il-mod ħalli jiġi evitat ir-riskju li jiżvilppaw sintomi ta' rtirar serji fil-pazjenti li jwaqqfu l-kura ħesrem.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of oral meprobamate-containing medicines do not outweigh their risks, and therefore recommended that all marketing authorisations for oral meprobamate-containing medicines should be suspended throughout the EU.
Maltese: Abbażi tal-valutazzjoni tad-dejta disponibbli fil-mument u tad-diskussjoni xjentifika li saret fil-Kumitat, is-CHMP ikkonkluda li l-benefiċċji tal-mediċini orali li fihom il-meprobamatu mhumiex akbar mir-riskji tagħhom, u għalhekk irrakkomanda li l-awtorizzazzjonijiet kollha għat-tqegħid fis-suq għall-mediċini orali li fihom il-meprobamatu għandhom issa jiġu sospiżi fl-UE kollha.
English: As required by Article 107, France informed the CHMP of its intention to suspend the marketing authorisations in France, so that the Committee could prepare an opinion on whether the marketing authorisations for products containing meprobamate should be maintained, changed, suspended or withdrawn across the EU.
Maltese: Kif meħtieġ mill-Artikolu 107, Franza infurmat lis-CHMP bil-ħsieb tagħha li tissospendi lawtorizzazzjonijiet għat-tqegħid fis-suq fi Franza, sabiex il-Kumitat ikun jista' jħejji opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għandhomx jinżammu, jinbidlu, jiġu sospiżi jew irtirati f-UE kollha.
English: What is meprobamate?
Maltese: X'inhi l-meprobamatu?
English: The European Medicines Agency has completed a review of the safety and effectiveness of oral meprobamate-containing medicines, due to serious side effects seen with the medicine.
Maltese: L-Aġenzija Ewropea għall-Mediċini lestiet reviżjoni tas-sigurtà u l-effikaċja ta' mediċini orali li fihom ilmeprobamatu, minħabba effetti sekondarji serji li dehru b'din il-mediċina.
English: • Patients should not stop their treatment without speaking to their doctor, since stopping treatment abruptly may lead to severe withdrawal symptoms.
Maltese: • Il-pazjenti m'għandhomx iwaqqfu l-kura mingħajr ma jkellmu lit-tabib tagħhom, minħabba li lwaqfien ħesrem tal-kura jista' jikkaġuna sintomi ta' rtirar serji.
English: In July 2011, the French medicines regulatory agency announced its intention to suspend the marketing authorisations for oral meprobamate-containing medicines because of serious side effects seen with these medicines.
Maltese: F'Lulju 2011 l-aġenzija Franċiża għall-mediċini kkonkludiet li dawn ilmiżuri ma kinux biżżejjed biex jiġi evitat it-teħid ta' dożi eċċessivi u l-iżvilupp ta' effetti sekondarji serji fi Franza.
English: The Committee acknowledged that it is important to allow for patients currently taking meprobamatecontaining medicines to be transferred gradually to alternative treatments, particularly due to the risks of severe withdrawal symptoms on stopping treatment abruptly.
Maltese: Il-Kumitat irrikonoxxa l-importanza li l-pazjenti li bħalissa qed jieħdu mediċini li fihom il-meprobamatu jingħataw il-possibbiltà li bil-mod il-mod jinbidlilhom it-trattament bl-għoti ta' kuri alternattivi, l-iżjed minħabba r-riskji ta' sintormi ta' rtirar severi meta l-kura titwaqqaf ħesrem.
English: Questions and answers on the suspension of the marketing authorisations for oral meprobamatecontaining medicines
Maltese: Mistoqsijiet u tweġibiet dwar is-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq għall-mediċini orali li fihom il-meprobamatu
English: All oral meprobamatecontaining medicines will be withdrawn from the EU market until any further data show that the benefits outweigh the risks.
Maltese: Il-mediċini orali kollha li fihom ilmeprobamatu ser jiġu rtirati mis-suq tal-UE sakemm dejta oħra turi li l-benefiċċji huma tabilħaqq akbar mir-riskji.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Maltese: ANNESS III SOMMARJU TAL-KARATTERISTIĊI
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-Sommarju tal-Karatteristiċi tal-Prodott, l-ittikkettar u l-fuljett ta' tagħrif validi huma l-verżjonijiet finali miksuba waqt il-proċedura tal-Grupp tal-Koordinazzjoni.
English: 10 November 2017 EMA/729957/2017 EMEA/H/C/004149
Maltese: 10 ta' Novembru 2017 EMA/729957/2017 EMEA/H/C/004149
English: Refusal of the marketing authorisation for Fanaptum (iloperidone) EMA/729957/2017
Maltese: (iloperidon) EMA/729957/2017
English: The active substance in Fanaptum, iloperidone, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Fanaptum, l-iloperidon, hija mediċina antipsikotika.
English: What is Fanaptum?
Maltese: X'inhu Fanaptum?
English: The company that applied for authorisation is Vanda Pharmaceuticals Ltd.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija Vanda Pharmaceuticals
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.
Maltese: Wara li kkunsidra r-raġunijet għal din it-talba, is-CHMP reġa' eżamina l-opinjoni, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fissuq fid-9 ta' Novembru 2017.
English: Fanaptum is a medicine that contains the active substance iloperidone.
Maltese: Fanaptum huwa mediċina li fiha s-sustanza attiva iloperidon.
English: The longterm study, involving 193 patients, compared Fanaptum with placebo.
Maltese: L-istudju ta' perjodu twil, li involva 193 pazjent, qabbel Fanaptum mal-plaċebo.