FrancophonIA/ELRC3.0 huggingface dataset:
English: Coombs-negative anisocytosis and poikilocytosis were observed in rats, but not in mice or dogs.
Maltese: Anisoċitożi Coombs-negative u pojkiloċitożi kienu osservati fil-far, iżda mhux fil-ġrieden u l-klieb.
English: Make sure you have the correct syringe for the dose.
Maltese: Jista jimmodifika jew iżid l-effetti ta' mediċini oħra.
English: 7.5 mg/ml Solution for injection
Maltese: Abilify 7,5 mg/ml Soluzzjoni għallinjezzjoni
English: Intramuscular use vial (glass)
Maltese: Għal użu għal ġol-muskoli kunjett (ħġieġ)
English: Barbara van Zwieten-Boot (NL)
Maltese: Dr. Barbara van Zwieten-Boot (NL)
English: 17 November 2009
Maltese: 17 ta' Novembru 2009
English: Co-rapporteur(s):
Maltese: Ko-relatur(i):
English: Rapporteur:
Maltese: Relatur:
English: This variation was to be recognised in Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom
Maltese: Din il-varjazzjoni kellha tkun rikonoxxuta flAwstrija, il-Belġju, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Lussemburgu, l
English: 25 January 2010, 3 May 2010 and 24 May 2010
Maltese: 25 ta' Jannar 2010, 3 ta' Mejju 2010 u 24 ta' Mejju 2010
English: What is Genotropin?
Maltese: X'inhu Genotropin?
English: 02 September 2010
Maltese: 02 ta' Settembru 2010
English: Outcome of a procedure under Article 6(12) of Regulation (EC) 1084/2003 as amended
Maltese: Riżultat ta' proċedura skont l-Artikolu 6(12) tar-Regolament (KE) 1084/2003 kif emendat
English: In 15 Member States of the EU, Genotropin is authorised under a mutual recognition procedure on the basis of the initial authorisation granted by Denmark on 7 May 19871.
Maltese: Fi 15-il Stat Membru tal-UE, Genotropin huwa awtorizzat taħt proċedura ta' rikonoxximent komuni fuq il-bażi ta' awtorizzazzjoni inizjali mogħtija mid-Danimarka fis-7 ta' Mejju 19871.
English: Somatropin is produced by a method known as ‘recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes it able to produce growth hormone.
Maltese: Somatropin huwa prodott permezz ta' metodu magħruf bħala ‘teknoloġija ta' DNA rikombinanti': huwa magħmul minn organiżmu li rċieva ġene (DNA), li jagħmlu kapaċi jipproduċi ormon tat-tkabbir.
English: Genotropin is a medicine that contains somatropin, which is a copy of natural growth hormone.
Maltese: Genotropin huwa prodott mediċinali li fih somatropin, li huwa kopja tal-ormon tat-tkabbir naturali.
English: In July 2008, Pfizer applied for a change (variation) to the marketing authorisation to add a new indication in Denmark (the ‘reference Member State').
Maltese: F'Lulju 2008, Pfizer applika għal bidla (varjazzjoni) għall-awtorizzazzjoni għat-tqegħid fis-suq sabiex tiżdied indikazzjoni ġdida fid-Danimarka (l-‘Istat Membru ta' referenza').
English: Why was Genotropin reviewed?
Maltese: Għaliex ġie rivedut Genotropin?
English: Procedure start date:
Maltese: Data tal-bidu tar-referenza:
English: It also looked at published information on the use of growth hormone in patients with JIA, and convened a meeting of experts, which included experts both in the treatment of hormonal disorders (endocrinologists) and in the treatment of joint diseases (rheumatologists).
Maltese: Ħares ukoll lejn informazzjoni ppubblikata dwar l-użu ta' ormon tat-tkabbir f'pazjenti b'JIA, u laqqa' ġabra ta' esperti, li kienet tinkludi kemm esperti fil-kura ta' disordnijiet ormonali (endokrinoloġisti) kif ukoll esperti fil-kura ta' mard tal-ġogi (rewmatoloġisti).
English: 24 June 2010
Maltese: 24 ta' Ġunju 2010
English: It is also used to correct short height in children who have the genetic diseases Turner syndrome and Prader Willi syndrome, and in children who have longstanding kidney problems.
Maltese: Jintuża wkoll sabiex jikkoreġi l-qosor fi tfal li għandhom il-mard ġenetiku tas-sindromu ta' Turner u tas-sindromu ta' Prader Willi, u fi tfal li għandhom problemi bil-kliewi fit-tul.
English: The new indication was the use of Genotropin in children on long-term treatment with steroids for juvenile idiopathic arthritis (JIA), a rare childhood disease causing inflammation of many joints.
Maltese: L-indikazzjoni lġdida kienet l-użu ta' Genotropin fi tfal li jingħataw kura fit-tul bi sterojdi għal artrite idjopatika tat-tfal (JIA), marda tat-tfulija rari li tikkawża infjammazzjoni f'ħafna mill-ġogi.
English: Genotropin, also marketed under the trade name Genotonorm, is available throughout the European Union (EU).
Maltese: Genotropin, li huwa mqiegħed fis-suq ukoll taħt l-isem kummerċjali Genotonorm, huwa disponibbli madwar l-Unjoni Ewropea (UE).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a change to the marketing authorisation for Genotropin to include a new indication for the treatment of stunted growth caused by the long-term use of steroids in children with juvenile idiopathic arthritis.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem tal-Aġenzija (CHMP) intalab li jarbitra dwar bidla fl-awtorizzazzjoni għat-tqegħid fis-suq għal Genotropin sabiex tinkludi indikazzjoni ġdida għallkura ta' tkabbir imxekkel ikkawżat minn użu fit-tul ta' sterojdi fi tfal b'artrite idjopatika tat-tfal.
English: The company that makes the medicine is Pfizer.
Maltese: Il-kumpanija li tagħmel dan il-prodott mediċinali hija Pfizer.
English: Growth hormone promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates.
Maltese: Lormon tat-tkabbir jippromwovi t-tkabbir waqt it-tfulija u l-adoloxxenza, u jaħdem ukoll fuq il-mod ta' kif il-ġisem jimmaniġġja l-proteini, ix-xaħam u l-karboidrati.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Genotropin cannot be approved in Denmark as well as in all concerned Member States.
Maltese: Fuq il-bażi tal-evalwazzjoni tad-data disponibbli u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP ikkonkluda li l-varjazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Genotropin ma setgħetx tkun approvata fid-Danimarka kif ukoll fl-Istati Membri kollha kkonċernati.
English: The European Medicines Agency has completed an arbitration procedure for Genotropin and associated names.
Maltese: L-Aġenzija Ewropea għall-Mediċini lestiet proċedura ta' arbitraġġ għal Genotropin u l-ismijiet assoċjati.
English: Another point was the fact that the company had presented too few data on the final height reached by the patients in the studies.
Maltese: IlKumitat ikkonkluda li l-bidla fl-awtorizzazzjoni għat-tqegħid fis-suq ma tistax tingħata.
English: Genotropin is used as replacement therapy in children and adults who have a growth hormone deficiency.
Maltese: Genotropin jintuża bħala terapija ta' rimpjazzament fi tfal u adulti li għandhom nuqqas tal-ormon tat-tkabbir.
English: The full EPAR for Leganto 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: • Parkinson's disease.
Maltese: • marda ta' Parkinson.
English: Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active substance rotigotine over 24 hours.
Maltese: Kull roqgħa terħi 1, 2, 3, 4, 6 jew 8 mg tas-sustanza attiva rotigotina f'24 siegħa.
English: EPAR summary for the public rotigotine
Maltese: Sommarju tal-EPAR għall-pubbliku rotigotina
English: Leganto was less effective than ropinirole: an improvement was seen in 70% of the patients receiving ropinirole.
Maltese: Leganto kien inqas effikaċi minn ropinirole: ġie nnotat titjib f'70% tal-pazjenti li ngħataw ropinirol.
English: In advanced Parkinson's disease, patients using Leganto had a greater decrease in their ‘off' time than those taking placebo (a decrease of 2.1 to 2.7 h with Leganto compared with 0.9 h with placebo).
Maltese: Fil-marda ta' Parkinson fl-istadju avvanzat, il-pazjenti ttrattati b'Leganto kellhom tnaqqis akbar filperjodu li tqiesu bħala 'off' minn dawk ittrattati bil-plaċebo (tnaqqis ta' 2.1 sa 2.7 h b'Leganto meta mqabbel ma' 0.9 h bil-plaċebo).
English: For restless legs syndrome, the maximum dose is 3 mg/24 h.
Maltese: Għas-sindromu tar-riġlejn irrekwieti, id-doża massima hija 3 mg/24 h.
English: This is a summary of the European public assessment report (EPAR) for Leganto.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Leganto.
English: • moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Maltese: • sindromu minn moderat sa gravi tar-riġlejn irrekwieti (restless legs syndrome), disturb li bih ilpazjent ikollu impulsi bla rażan biex iċaqlaq riġlejh ħalli jwaqqaf sensazzjonijiet skomdi li jweġġgħu jew strambi fil-ġisem, normalment bil-lejl.
English: The decrease seen with Leganto was similar to that seen with pramipexole (2.8 h).
Maltese: It-tnaqqis innotat b'Leganto kien simili għal dak li ntwera bi pramipexole (2.8 h).
English: In early-stage disease, 48 to 52% of the patients using Leganto had an improvement in symptoms, compared with 19 to 30% of those using placebo.
Maltese: Fil-marda fi stadju bikri, bejn 48% u 52% tal-pazjenti li użaw Leganto kellhom titjib fis-sintomi, meta mqabbla mad-19% sa 30% ta' dawk li ngħataw il-plaċebo.
English: The maximum dose is 8 mg/24 h for early-stage Parkinson's disease and 16 mg/24 h for advanced disease.
Maltese: Għall-marda ta' Parkinson fi stadju bikri d-doża massima hija 8 mg/24 h mentri d-doża għall-istadju avvanzat tagħha hija 16 mg/24 h.
English: This summary was last updated in 02-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'02-2013.
English: In Parkinson's disease, Leganto has been compared with placebo (a dummy treatment) in four studies involving 830 patients with early-stage disease and 842 patients with advanced disease.
Maltese: Fil-marda ta' Parkinson, Leganto tqabbel ma' plaċebo (trattament finta) f'erba' studji li fihom ħadu sehem 830 pazjent bil-marda fi stadju bikri u 842 pazjent bil-marda fi stadju avvanzat.
English: The most common side effects with Leganto in patients with Parkinson's disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, headache, nausea (feeling sick), vomiting, and application site reactions such as redness, itching and irritation of the skin.
Maltese: L-effetti sekondarji l-aktar komuni b'Leganto fil-pazjenti bil-marda ta' Parkinson (li dehru f'aktar minn pazjent 1 minn 10) huma ħedla, sturdament, uġigħ ta' ras, nawżja (dardir), remettar u reazzjonijiet filpost fejn titqiegħed ir-roqgħa, bħal irritazzjoni u ħruq fil-ġilda.
English: The active substance in Leganto, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Maltese: Is-sustanza attiva f'Leganto, ir-rotigotina, hija agonista tad-dopamina li jfisser li timita l-azzjoni taddopamina.
English: Why has Leganto been approved?
Maltese: Għaliex ġie approvat Leganto?
English: What is Leganto?
Maltese: X'inhu Leganto?
English: In moderate to severe restless legs syndrome, Leganto has been compared with placebo in two main studies involving a total of 963 patients.
Maltese: Fis-sindromu moderat sa gravi tar-riġlejn irrekwieti Leganto tqabbel ma' plaċebo f'żewġ studji ewlenin li fihom ħadu sehem total ta' 963 pazjent.
English: The company that makes Neupro has agreed that its scientific data can be used for Leganto (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Neupro qablet li d-dejta xjentifika tagħha tista' tintuża għal Leganto (“kunsens infurmat”).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leganto on 16 June 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Leganto valida fl-Unjoni Ewropea kollha fis-16 ta' Ġunju 2011.
English: Leganto is used to treat the symptoms of the following diseases in adults:
Maltese: Leganto jintuża fit-trattament tas-sintomi tal-mard li ġej f'adulti:
English: Two of these studies also compared Leganto with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease).
Maltese: Tnejn minn dawn l-istudji qabblu wkoll Leganto ma' agonisti tad-dopamina oħrajn (ropinirolo fil-marda fi stadju bikri u l-pramipexolo fi stadju avvanzat).
English: What is the risk associated with Leganto?
Maltese: X'inhu r-riskju assoċjat ma' Leganto?
English: In restless legs syndrome, patients using doses of Leganto between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.
Maltese: Fis-sindromu tar-riġlejn irrekwieti, il-pazjenti ttrattati b'dożaġġi ta' Leganto ta' bejn 1 u 3 mg/24 h kellhom titjib akbar minn dawk ittrattati bil-plaċebo fiż-żewġ studji, hekk kif imkejjel fiż-żewġ skali tassintomi.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Maltese: Huwa maħsub li s-sindromu huwa kkawżat minn problemi fil-mod kif id-dopamina taħdem fil-moħħ li jista' jitjieb permezz tar-rotigotina.
English: For the full list of all side effects reported with Leganto, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Leganto, ara lfuljett ta' tagħrif.
English: Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination.
Maltese: Id-dopamina hija sustanza li taħdem bħala messaġġier fil-partijiet tal-moħħ li jikkontrollaw il-moviment u l-koordinazzjoni.
English: The studies in early-stage disease looked at the number of patients who had at least a 20% improvement in symptoms, as measured with a standard symptom questionnaire.
Maltese: L-istudji li saru fil-marda fi stadju bikri analizzaw l-għadd ta' pazjenti li kellhom tal-inqas 20% titjib fis-sintomi, kif imkejjel permezz ta' kwestjonarju standard dwar is-sintomi.
English: In smaller studies completed later, the effectiveness of Leganto was found to be comparable with ropinirole.
Maltese: Fl-istudji ż-żgħar li saru wara, l-effikaċja ta' Leganto instabet li kienet komparabbli mar-ropinirol.
English: Other information about Leganto
Maltese: Kif jintuża Leganto?
English: A special pack with patches of four different strengths is available to help when starting treatment for early-stage Parkinson's disease.
Maltese: Leganto kien aktar effikaċi mill-plaċebo fit-trattament tal-marda ta' Parkinson.
English: The patch is applied to dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm.
Maltese: Ir-roqgħa titqiegħed fuq ġilda xotta, nadifa u f'saħħitha fuq l-addome (iż-żaqq), il-koxxa, il-ġenbejn, il-ġenb, l-ispalla jew fil-parti ta' fuq tad-driegħ.
English: The patients then lose their ability to control their movements reliably.
Maltese: Għalhekk il-pazjenti jitilfu lħila li jikkontrollaw b'mod affidabbli l-movimenti tagħhom.
English: This medicine is the same as Neupro, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Neupro, li hija diġà awtorizzata fl-Unjoni Ewropea (UE).
English: The studies in advanced disease measured the length of time during the day that the patients recorded as ‘off' (when they had too many Parkinson's disease symptoms to be able to live normally).
Maltese: Biex jinbeda t-trattament tal-marda ta' Parkinson fi stadju bikri huwa disponibbli pakkett speċjali li fih irqajja' b'erba' dożaġġi differenti.
English: Rotigotine then stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Maltese: Ir-rotigotina mbagħad tistimola l-moħħ hekk kif tagħmel iddopamina, biex b'hekk il-pazjenti jikkontrollaw il-movimenti tagħhom u jkollohom inqas sinjali u sintomi tal-marda ta' Parkinson, bħall-ebusija u d-dewmien fil-movimenti.
English: EMA/793954/2015 EMEA/H/C/002661
Maltese: EMEA/H/C/002661
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom multiply, and so its reduction in the blood causes the cells to die.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The full EPAR and risk management plan summary for Spectrila 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: Other information about Spectrila
Maltese: Informazzjoni oħra dwar Spectrila
English: Spectrila asparaginase
Maltese: Spectrila asparaginażi
English: This is a summary of the European public assessment report (EPAR) for Spectrila.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Spectrila.
English: Why is Spectrila approved?
Maltese: Għal xiex ġie approvat Spectrila?
English: The most common side effects with Spectrila (which may affect more than 1 in 10 people) are allergic reactions (including flushing, rash, low blood pressure, hives and difficulty breathing), diarrhoea, nausea, vomiting, abdominal pain, tiredness, swelling (caused by fluid build-up), high blood sugar, and low blood levels of albumin (a protein) and other abnormalities in blood tests.
Maltese: L-effetti sekondarji l-aktar komuni bi Spectrila (li jaffettwaw aktar minn persuna 1 minn kull 10) huma reazzjonijiet allerġiċi (inkluż fwawar, raxx, pressjoni tad-demm baxxa, ħorriqija u diffikultà fit-teħid tan-nifs), dijarrea, dardir, rimettar, uġigħ addominali, għeja, nefħa (ikkawżata minn akkumulazzjoni ta' fluwidi), livell għoli ta' zokkor fid-demm, u livelli baxxi ta' albumina (proteina) fid-demm u abnormalitajiet oħrajn fit-testijiet tad-demm.
English: Although the data in adults are limited, there is substantial clinical experience of asparaginase medicines in adults, and the benefits of Spectrila in adults can be expected to be similar.
Maltese: Għalkemm id-dejta fl-adulti hija limitata, hemm esperjenza klinika sostanzjali ta' asparaginażi fl-adulti, u l-benefiċċji ta' Spectrila fl-adulti jistgħu jkunu mistennija li jkunu simili.
English: In a study in 199 children with ALL, Spectrila was as effective as another asparaginase medicine (both used in combination with other medicines) in reducing blood asparagine: 95% of patients treated with Spectrila and 94% of those treated with the other medicine containing asparaginase had complete depletion (reduction) of blood asparagine.
Maltese: Fi studju f'199 tifel/tifla b'ALL, Spectrila kien effettiv daqs mediċina asparaginażi oħra (it-tnejn użati f'kombinazzjoni ma' mediċini oħrajn) fit-tnaqqis tal-asparagina fid-demm: 95% tal-pazjenti kkurati bi Spectrila u 94% ta' dawk ikkurati bil-mediċina l-oħra li fiha l-asparaginażi kellhom tnaqqis sħiħ talasparagina fid-demm.
English: What are the risks associated with Spectrila?
Maltese: X'inhuma r-riskji assoċjati ma' Spectrila?
English: Spectrila is used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts, in combination with other cancer medicines.
Maltese: Spectrila hija mediċina għall-kura ta' lewkimja limfoblastika akuta (ALL, acute lymphoblastic leukaemia), kanċer ta' ċelloli tad-demm bojod imsejħin limfoblasts.
English: The most serious side effects with Spectrila include severe allergic reactions, blood clots, pancreatitis (inflammation of the pancreas), and liver problems.
Maltese: L-effetti sekondarji l-aktar serji bi Spectrila jinkludu reazzjonijiet allerġiċi severi, emboli tad-demm, pankreatite (infjammazzjoni tal-frixa), u problemi fil-fwied.
English: The active substance in Spectrila, asparaginase, is an enzyme that works by breaking up and reducing the blood levels of the amino acid asparagine.
Maltese: Is-sustanza attiva fi Spectrila, l-asparaginażi, hija enzima li taħdem billi tkisser u tnaqqas il-livelli taddemm tal-asparagina tal-aċidu amminiku (amino acid asparagine).
English: As for its risks, the side effects of Spectrila are similar to those of other asparaginase medicines and are addressed in the medicine's risk minimisation plan.
Maltese: Fir-rigward tar-riskji tagħha, l-effetti sekondarji ta' Spectrila huma simili għal dawk ta' mediċini asparaginażi oħrajn u huma indirizzati fil-pjan ta' minimizzazzjoni tar-riskju tal-mediċina.
English: A risk management plan has been developed to ensure that Spectrila is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġu żgurat li Spectrila jintuża bl-aktar mod sigur possibbli.
English: Spectrila is given every 3 days by infusion (drip) into a vein, with the dose depending on the patient's age and body surface area.
Maltese: Spectrila jingħata kull 3 ijiem b'infużjoni (dripp) fil-vina, bid-doża dipendenti fuq l-età tal-pazjent u lerja tas-superfiċje tal-ġisem.
English: For the full list of side effects reported with Spectrila, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Spectrila, ara l-fuljett ta' tagħrif.
English: Further information can be found in the summary of the risk management plan.
Maltese: Aktar informazzjoni tinstab fis-sommarju tal-pjan tal-ġestjoni tar-riskju
English: What measures are being taken to ensure the safe and effective use of Spectrila?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effikaċi ta' Spectrila?
English: How does Spectrila work?
Maltese: Kif jaħdem Spectrila?
English: Spectrila can only be obtained with a prescription and is available in a vial as a powder to be made into a solution for infusion.
Maltese: Spectrila jista' jinkiseb biss b'riċetta ta' tabib u huwa disponibbli f'kunjett bħala trab sabiex imbagħad ikun magħmul soluzzjoni għal infużjoni.
English: Invented name
Maltese: Numru tal-EU Isem inventat
English: Strength Pharmaceutical Form Route of administration Packaging
Maltese: Qawwa Għamla farmaċewtika
English: • Dosing reference card
Maltese: • Karta ta' referenza għad-dożaġġ
English: • Information about the potential safety risks of errors in dosing calculation resulting from the confusion between the two formulations and its possible clinical consequences (e.g. potential for thrombotic risk if overdose).
Maltese: • Informazzjoni dwar ir-riskji potenzjali għas-sigurtà ġejjien minn żbalji fil-kalkulazzjoni tad doża minħabba l-konfużjoni bejn iż-żewġ formulazzjonijiet u l-konsegwenzi kliniċi li dawn jistgħu jġibu (e.g. riskju potenzjali ta' trombożi f'każ ta' doża eċċessiva)
English: Both information packs are to be used as part of an educational plan provided to minimise risk of medication errors that may be associated with the change in concentration of the new Novoseven formulation.
Maltese: Iż-żewġ pakketti ta' informazzjoni għandhom ikunu użati bħala parti minn pjan edukattiv imfassal biex inaqqas kemm jista' jkun ir-riskju ta' żbalji ta' medikazzjoni li jista' jkun hemm minħabba ttibdil fil-konċentrazzjoni fil-formulazzjoni l-ġdida ta' NovoSeven.
English: • Physician information pack
Maltese: • Pakkett ta' informazzjoni għat-tabib
English: • Educational slide kit
Maltese: • Sett ta' slajds edukattivi
English: The physician information should contain the following key elements:
Maltese: Fl-informazzjoni għat-tabib għandu jkun hemm dawn il-punti importanti li ġejjien:
English: • Clear information about their difference in concentration.
Maltese: • Informazzjoni ċara dwar id-differenza fil-konċentrazzjoni
English: • Summary leaflet of the product features and reconstitution guide, including highlighted changes that have been made for the new formulation of NovoSeven.
Maltese: • Diviżjoni ċara bejn il-formulazzjoni ġdida ta' Novoseven u dik oriġinali ta' NovoSeven,