FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in every 10 people) - involuntary shaking of the body - cough with phlegm, chest pain, fever (bronchitis) - cold sores in the mouth due to viral infection (oral herpes) - painful and frequent urination (cystitis) - feeling of pressure or pain in the cheeks and forehead (sinusitis) - red, swollen painful rash on any part of the skin (erysipelas) - shingles (herpes zoster) - disturbance in attention - feeling dizzy with spinning sensation (vertigo) - bruising (haematoma) - upset stomach, indigestion - feeling weak (asthenia) - chills - generalised swelling (oedema) - increased weight - contusion (bruises) - falls - dizziness, light-headedness (low blood pressure) - sore throat
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - tregħid mal-ġisem b'mod involontarju - sogħla bil-bili, uġigħ f'sidrek, deni (bronkite) - infafet fil-ħalq minħabba infezzjoni virali (erpite orali) - tgħaddi l-awrina spiss u bl-uġigħ (ċistite) - tħoss pressjoni jew uġigħ f'ħaddejk u fuq ġbinek (sinużite) - raxx aħmar, b'nefħa u b'uġigħ fi kwalunkwe parti tal-ġilda (erisipelas) - Ħruq ta' Sant'Antnin (erpite zoster) - disturb fl-attenzjoni - tħossok stordut u tħoss rasek iddur bik (vertigo) - tbenġil (ematoma) - dwejjaq fl-istonku, indiġestjoni - tħossok għajjien (astenja) - dehxiet ta' bard - nefħa b'mod ġenerali (edema) - żieda fil-piż - kontużjoni (tbenġil) - taqa' - sturdament, tħoss rasek ħafifa (pressjoni baxxa) - griżmejn misluħin
English: Very common (may affect more than 1 in 10 people) - infection at catheter site - red or purple, flat, pinhead spots under the skin (petechiae) - problems falling asleep (insomnia) - headache - shortness of breath, laboured breathing (dyspnoea) - dizziness, light-headedness (low blood pressure) - nose bleeds - throat pain (laryngeal pain) - mouth sores (stomatitis) - nausea, vomiting - upper abdominal pain - haemorrhoids (piles) - excessive sweating - skin rash with flaking or peeling (exfoliative dermatitis) - back pain - joint pain (arthralgia) - fever - thirst, high urine output, dark urine, dry flushed skin (signs of high levels of sugar in the blood,
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) - infezzjoni tal-apparat urinarju - infezzjoni fin-naħa ta' fuq tal-passaġġ respiratorju - uġigħ ta' ras - sturdament - qtugħ ta' nifs, diffikultà kbira biex tieħu n-nifs (dispnea) - sogħla - fluwidu miġmugħ fil-pulmun/qafas ta' sidrek, li, jekk ikun sever, jista' jħallik bla nifs (effużjoni plewrali) - tinfaġar - dardir, rimettar - dijarrea - konstipazzjoni - telf mgħaġġel tal-piż, nefħa fl-estremitajiet (pxiexen, għekiesi) - tħossok għajjien ħafna (għeja) - deni - għatx, ammont għoli ta' awrina, awrina skura, ġilda xotta u ħamra (sinjali ta' livelli għoljin ta'
English: Of the 116 patients enrolled, 89 were considered eligible for response assessment and constituted the primary efficacy population.
Maltese: Mill-116-il pazjent imsieħba, 89 kienu meqjusa eliġibbli għal evalwazzjoni tar-rispons u kienu jikkonsistu fil-popolazzjoni li tivverifika l-effikaċja primarja.
English: Animal studies with midostaurin have shown impaired fertility (see section 5.3).
Maltese: Studji fuq l-annimali dwar midostaurin urew fertilità mdgħajfa (ara sezzjoni 5.3).
English: Midostaurin undergoes extensive hepatic metabolism mainly through CYP3A4 enzymes which are either induced or inhibited by a number of concomitant medicinal products.
Maltese: Midostaurin jgħaddi minn metaboliżmu epatiku estensiv primarjament permezz tal-enzimi CYP3A4 li jew huma indotti jew inibiti minn numru ta' prodotti mediċinali mogħtija fl-istess ħin.
English: In humans, the absorption of midostaurin was rapid after oral administration, with Tmax of total radioactivity observed at 1-3 hours post dose.
Maltese: Fil-bnedmin, l-assorbiment ta' midostaurin kien rapidu wara li ngħata mill-ħalq, bit-Tmax ta' radjuattività totali osservat bejn 1-3 sigħat wara li ngħatat id-doża.
English: Nasopharyngitis
Maltese: Settembru
English: In patients receiving a haematopoietic stem cell transplant (SCT), Rydapt should be discontinued 48 hours prior to the conditioning regimen for SCT.
Maltese: F'pazjenti mogħtija trapjant taċċellula steminali ematopojetika (SCT), Rydapt għandu jitwaqqaf 48 siegħa qabel ir-reġim kundizzjonanti għal SCT.
English: Enzyme drug-drug interactions
Maltese: Reazzjoni avversa tal-mediċina
English: Rydapt is used to treat acute myeloid leukaemia (AML) in adults who have a defect in a gene called FLT3.
Maltese: Rydapt jintuża biex jittratta lewkimja majelojde akuta (AML) f'adulti li għandhom difett f'ġene msejjaħ FLT3.
English: Oropharyngeal pain
Maltese: Manutenzjoni biss
English: In clinical studies, the efficacy and safety of Rydapt were investigated following administration with a light meal.
Maltese: Fi studji kliniċi, l-effikaċja u s-sigurtà ta' Rydapt kienu investigati wara li ngħata ma' ikla ħafifa.
English: CGP52421 concentrations do not appear to decline as significantly as for midostaurin and CGP62221.
Maltese: Il-konċentrazzjonijiet ta' CGP52421 ma jidhirx li naqsu b'mod qawwi għal midostaurin u CGP62221.
English: Midostaurin interferes with aberrant KIT D816V-mediated signalling and inhibits mast cell proliferation, survival and histamine release.
Maltese: Midostaurin jinterferixxi ma' senjalazzjoni aberranti permezz ta' KIT D816V u jinibixxi lproliferazzjoni taċ-ċellula steminali, is-sopravivenza u l-ħruġ tal-istamina.
English: ADRs reported during the maintenance phase led to discontinuation of 1.2% of patients in the Rydapt arm and none in the placebo arm.
Maltese: L-ADRs irrappurtati matul il-fażi ta' manutenzjoni wasslu għal twaqqif totali ta' 1.2% tal-pazjenti filgrupp mogħti Rydapt u xejn fil-grupp mogħti l-plaċebo.
English: 2key secondary endpoint; NE: Not Estimated Hazard ratio (HR) estimated using Cox regression model stratified according to the randomisation FLT3 mutation factor.
Maltese: Effetti sekondarji possibbli oħrajn f'pazjenti b'AML Effetti sekondarji oħrajn jinkludu dawk imniżżla hawn taħt.
English: There is limited experience with midostaurin in AML patients aged 60-70 years and no experience in AML patients above 70 years.
Maltese: Hemm esperjenza limitata b'midostaurin f'pazjenti AML li għandhom bejn 60 u 70 sena u l-ebda esperjenza f'pazjenti AML li għandhom aktar minn 70 sena.
English: It is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception (see section 4.6).
Maltese: Bħalissa mhuwiex magħruf jekk midostaurin jistax inaqqas l-effettività ta' kontraċettivi ormonali, u għalhekk nisa li qed jużaw kontraċettivi ormonali għandhom jużaw ukoll kontraċettiv b'metodu ta' barriera (ara sezzjoni 4.6).
English: Each soft capsule contains 25 mg midostaurin.
Maltese: Kull kapsula ratba fiha 25 mg midostaurin.
English: The capsules should be taken with food (see sections 4.5 and 5.2).
Maltese: Il-kapsuli għandhom jittieħdu mal-ikel (ara sezzjonijiet 4.5 u 5.2).
English: Based on a phase I study in healthy Japanese volunteers, pharmacokinetic profiles of midostaurin and its metabolites (CGP62221 and CGP52421) are similar compared to those observed in other pharmacokinetic studies conducted in Caucasians and Blacks.
Maltese: Skont studju f'fażi I fost volunitera Ġappuniżi b'saħħithom, il-profili farmakokinetiċi ta' midostaurin u l-metaboliti tiegħu (CGP62221 u CGP52421) jixxiebhu mqabbel ma' dawk osservati fi studji farmakokinetiċi oħrajn imwettqa fost Kawkażjatiċi u Suwed.
English: Interrupt Rydapt until toxicities considered at least possibly related to Rydapt have resolved to Grade ≤2, then resume Rydapt.
Maltese: Interrompi Rydapt sakemm it-tossiċitajiet ikkunsidrati tal-inqas possibbilment relatati ma' Rydapt ikunu għaddew għal Grad ≤2, imbagħad kompli Rydapt.
English: In healthy subjects, midostaurin absorption (AUC) was increased by an average of 22% when Rydapt was co-administered with a standard meal and by an average of 59% when co-administered with a high-fat meal.
Maltese: F'individwi b'saħħithom, l-assorbiment ta' midostaurin (AUC) żdied b'medja ta' 22% meta Rydapt ingħata ma' ikla normali u b'medja ta' 59% meta ngħata flimkien ma' ikla b'kontenut għoli ta' xaħam.
English: Hyperglycaemia
Maltese: Uġigħ fl-estremitajiet
English: 33.9 months (95% CI: 20.7, 42), than for KIT D816V wild type or unknown patients, i.e. 10 months (95% CI: 6.9, 17.4).
Maltese: Madanakollu, issopravivenza medjana għal KITB D816V pazjenti pożittivi kienet itwal, jiġifieri ta' 33.9 xhur (95% CI: 20.7, 42), milli għal pazjenti b'KIT D816V tat-tip selvaġġ jew mhux magħrufa, jiġifieri ta' 10 xhur (95% I: 6.9, 17,4).
English: Table 5 Efficacy of midostaurin in AML
Maltese: Sopraviv enza Medjana (xhur)
English: *Confirmation period for responses: 12 weeks
Maltese: *Perjodu ta' konferma għar-risponsi: 12-il ġimgħa
English: Methylphenidate Hexal (18 mg, 36 mg and 54 mg) is indicated in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in children aged between 6 and 18 years old once daily in the morning and can be taken with or without food.
Maltese: Methylphenidate Hexal (18 mg, 36 mg u 54 mg) huwa indikat fil-kura tad-disturb ta' Nuqqas ta' Attenzjoni/Attività Eċċessiva (ADHD) fi tfal ta' bejn 6 u 18-il sena, darba kuljum filgħodu u jista' jittieħed mal-ikel jew fuq stonku vojt.
English: The PK parameters for the fed study for the immediate release phase were the following: Cmax(0-2h) = 74.8 -142.7 and AUC (0-2h) = 60.0 - 155.6 (90% CI).
Maltese: Il-parametri PK tal-istudju li fih il-mediċina ngħatat wara l-ikel, għall-fażi li terħi l-mediċina b'mod immedjat, kienu dawn li ġejjin: Cmax(0-2h) = 74.8 -142.7 u AUC (0-2h) = 60.0155.6
English: Methylphenidate Hexal which contains the active substance methylphenidate hydrochloride is an osmotic controlled prolonged release film coated tablet with a bi-layer core.
Maltese: Methylphenidate Hexal, li fih is-sustanza attiva methylphenidate hydrochloride, huwa pillola miksija b'rita, b'qalba b'żewġ saffi, li terħi l-mediċina bil-mod, ikkontrollata b'mod osmotiku.
English: • The Committed reviewed all the data submitted by the applicant in order to support the bioequivalence between Methylphenidate Hexal 18 mg, 36 mg, 54 mg prolonged release tablets and the reference product.
Maltese: • Il-Kumitat ivvaluta d-dejta kollha ppreżentata mill-applikant sabiex jappoġġa l-bijoekwivalenza bejn Methylphenidate Hexal 18 mg, 36 mg, 54 mg pilloli li jerħu l-mediċina bil-mod u l-prodott ta' referenza.
English: The repeat-use MRP marketing authorisation application presented for the medicinal product Methylphenidate Hexal 18mg, 36mg, 54mg tablets is a generic application in accordance with the Article 10.1 of the Directive 2001/83/EC.
Maltese: L-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq skont il-proċedura ta' rikonoxximent reċiproku (MRP) għall-użu ripetut ippreżentata għall-prodott mediċinali Methylphenidate Hexal 18mg, 36mg, 54mg pilloli hija applikazzjoni ġenerika skont l-Artikolu 10.
English: Overall summary of the scientific evaluation of Methylphenidate Hexal and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Methylphenidate Hexal u ismijiet assoċjati (ara Anness I)
English: However, the Committee is of the opinion that the observed deviation is attributed to variability between subjects and to physiological conditions after intake of a high fat meal and this does not translate into differences in quality between Methylphenidate Hexal and the reference formulations.
Maltese: Madankollu, il-Kumitat huwa tal-opinjoni li d-devjazzjoni osservata hija attribwita għall-varjabbiltà bejn l-individwi u għal kundizzjonijiet fiżjoloġiċi wara t-teħid ta' ikla b'kontenut għoli ta' xaħam u ma tfissirx differenzi filkwalità bejn Methylphenidate Hexal u l-formulazzjonijiet ta' referenza.
English: Regarding the results obtained in the fed study (2009-18-PRT-2) it was shown that when compared to the fasting study several subjects did not have a biphasic profile but a continuous profile without an early maximum, whereby methylphenidate concentrations slowly increase after an erratic lag time.
Maltese: Rigward ir-riżultati miksuba fl-istudju li fih il-mediċina ngħatat wara l-ikel (2009-18-PRT-2), intwera li meta pparagunat mal-istudju li fih il-mediċina ngħatat fuq stonku vojt, diversi individwi ma kellhomx profil b'żewġ fażijiet iżda profil kontinwu mingħajr konċentrazzjoni massima bikrija, fejn ilkonċentrazzjonijiet ta' methylphenidate jiżdiedu bil-mod wara intervall (lag time) erratiku.
English: Methylphenidate Hexal's formulation is designed with an outer coating containing the immediaterelease part surrounding the prolonged-release core (osmotic controlled).
Maltese: Il-formulazzjoni ta' Methylphenidate Hexal hija ddisinjata b'kisja fuq barra li fiha l-parti li terħi lmediċina mill-ewwel madwar il-qalba li terħi l-mediċina bil-mod (ikkontrollata b'mod osmotiku).
English: Waiver of studies under fed conditions for the 18 mg and 36 mg strengths The bioequivalence under fed conditions has only been studied in the 54 mg strength.
Maltese: Rinunzja għall-istudji f'kundizzjonijiet ta' wara l-ikel għall-qawwiet ta' 18 mg u 36 mg Il-bijoekwivalenza wara l-ikel ġiet studjata biss fil-qawwa ta' 54 mg.
English: A referral was thus triggered at the CMD(h).
Maltese: Għalhekk inbeda riferiment fis-CMD(h).
English: Further information on Panretin 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: The marketing authorisation holder is Eisai Ltd.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Eisai Ltd.
English: The most common side effects with Panretin (which may affect more than 1 patient in 10) are rash, pruritus (itching), skin disorders (cracking, scabbing, crusting, draining, oozing) and pain (burning, soreness).
Maltese: L-effetti sekondarji l-aktar komuni b'Panretin (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma raxx, pruritu (ħakk), disturbi tal-ġilda (xquq, qoxra, materja niexfa, ħruġ ta' likwidu, likwidu li jibqa' joħroġ bil-mod) u uġigħ (ħruq, qtugħ ta' laħam).
English: Around 35% and 37% of the patients using Panretin responded to treatment compared with 18% and 7% of the patients using placebo.
Maltese: Madwar 35 % u 37 % talpazjenti li kienu qed jużaw Panretin irrispondew għall-kura meta mqabbel ma' 18 % u 7 % tal-pazjenti li kienu qed jużaw il-plaċebo.
English: Panretin was compared with placebo (a dummy treatment) in two 12-week studies involving a total of 402 patients with Kaposi's sarcoma.
Maltese: Panretin tqabbel mal-plaċebo (kura finta) f'żewġ studji ta' 12-il ġimgħa li involvew total ta' 402 pazjenti bis-sarkoma ta' Kaposi.
English: Other information about Panretin
Maltese: Informazzjoni oħra dwar Panretin
English: The active substance in Panretin, alitretinoin, is an anticancer agent that belongs to the group ‘retinoids', substances that are derived from vitamin A. The exact way alitretinoin works in Kaposi's sarcoma is unknown.
Maltese: Is-sustanza attiva f'Panretin, alitretinoin, hija aġent kontra l-kanċer li tappartjeni għall-grupp “retinojdi”, sustanzi li huma derivati mill-vitamina A.
English: What are the risks associated with Panretin?
Maltese: X'inhuma r-riskji assoċjati ma' Panretin?
English: Panretin received a marketing authorisation valid throughout the EU on 11 October 2000.
Maltese: Panretin irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fil-11 ta' Ottubru 2000.
English: As for all medicines, data on the use of Panretin are continuously monitored.
Maltese: Bħal fil-każ ta' kull mediċina, id-data dwar l-użu ta' Panretin hija ssorveljata kontinwament.
English: • treatment for visceral (internal) Kaposi's sarcoma is not needed.
Maltese: • ma tkunx meħtieġa kura għal sarkoma ta' Kaposi vixxerali (interna).
English: Panretin is a medicine used to treat the skin lesions seen in AIDS patients with Kaposi's sarcoma (a type of skin cancer).
Maltese: Panretin huwa mediċina li tintuża biex tikkura l-leżjonijiet tal-ġilda li jidhru f'pazjenti tal-AIDS b'sarkoma ta' Kaposi (tip ta' kanċer tal-ġilda).
English: Panretin is used when:
Maltese: Panretin jintuża meta:
English: • the lesions have not responded to HIV treatment,
Maltese: • il-leżjonijiet ma jkunux irrispondew għall-kura tal-HIV,
English: • other treatments (radiotherapy or chemotherapy) are not suitable, and
Maltese: • kuri oħra (radjoterapija jew kimoterapija) ma jkunux xierqa, u
English: How is Panretin used?
Maltese: Panretin?
English: Side effects reported with Panretin are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Panretin huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Panretin is available as a gel to be applied to the skin lesions twice a day, using enough gel to cover each lesion with a generous coating and then leaving it to dry for three to five minutes before covering with clothing.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Panretin, ara l-fuljett ta' tagħrif.
English: How does Panretin work?
Maltese: Kif jaħdem Panretin?
English: ATC code: A10AD05.
Maltese: A10AD05.
English: Elderly (≥65 years old)
Maltese: Anzjani (≥ 65 sena)
English: Novo Nordisk Production SAS 45, Avenue d'Orléans F-28000 Chartres France
Maltese: Novo Nordisk Production SAS 45, Avenue d'Orléans F-28000 Chartres Franza
English: Date of last renewal: 2 July 2010
Maltese: Data ta' l-aħħar tiġdid: 2 ta' Lulju 2010
English: -2 units
Maltese: -2 unitajiet
English: • The active substance is insulin aspart.
Maltese: • Is-sustanza attiva hi insulin aspart.
English: Figure 1: Activity profile of NovoMix 30 (___) and biphasic human insulin 30 (---) in healthy subjects.
Maltese: Figura 1: Profil ta' l-attività ta' NovoMix 30 (___) u l-insulina umana bifażika 30 (---) f'suġġetti b'saħħithom.
English: ► You can select doses from 1 to 60 units in increments of 1 unit.
Maltese: ► Tista' tisselezzjona dożi minn 1 sa 60 unità f'inkrementi ta' unità 1.
English: Making the injection
Maltese: Buttuna tal injezzjoni
English: 1 ml contains 100 units of insulin aspart.
Maltese: Millilitru fih 100 unità ta' insulin aspart.
English: EU/1/00/142/023 1 pen of 3 ml EU/1/00/142/009 5 pens of 3 ml EU/1/00/142/010 10 pens of 3 ml EU/1/00/142/024 1 pen of 3 ml and 7 NovoFine needles EU/1/00/142/025 1 pen of 3 ml and 7 NovoTwist needles
Maltese: EU/1/00/142/023 pinna 1 ta' 3 ml EU/1/00/142/009 5 pinen ta' 3 ml EU/1/00/142/010 10 pinen ta' 3 ml EU/1/00/142/024 pinna 1 ta' 3 ml u 7 labar NovoFine EU/1/00/142/025 pinna 1 ta' 3 ml u 7 labar NovoTwist
English: The individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day.
Maltese: Il-ħtieġa individwali tal-insulina normalment hi ta' bejn 0.5 u 1.0 unitajiet/kg/kuljum.
English: +6 units
Maltese: +6 unitajiet
English: Store below 30°C Do not freeze
Maltese: Aħżen f'temperatura taħt 30°C.
English: +4 units
Maltese: +4 unitajiet
English: NovoMix 30 can also be given in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists.
Maltese: NovoMix 30 jista' wkoll jingħata flimkien ma' prodotti mediċinali antidijabetiċi orali u/jew agonisti tar-riċettur GLP-1.
English: With NovoMix 30, 66% and 42% of the patients reached HbA1c levels below 7% and 6.5%, respectively, and mean FPG was reduced by about 7 mmol/l (from 14.0 mmol/l at baseline to 7.1 mmol/l).
Maltese: HbA1c taħt 7% u 6.5%, rispettivament, u l-medja ta' FPG tnaqqset b'madwar 7 mmol/l (minn linja bażi ta' 14.0 mmol/l għal 7.1 mmol/l).
English: Absorption, distribution and elimination
Maltese: L-assorbiment, id-distribuzzjoni u l-eliminazzjoni
English: Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) ; mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: • Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)
Maltese: • Simpatomimetiċi ( bħal epinephrine [adrenaline], salbutamol jew terbutaline użati fil-kura talażma)
English: • Glucocorticoids (such as ‘cortisone' used to treat inflammation)
Maltese: • Glukokortikojdi (bħal ‘cortisone' użat fil-kura tal-infjammazzjoni)
English: *Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Maltese: * Insulin aspart huwa magħmul f'Saccharomyces cerevisiae permezz tat-teknoloġija rikombinanti tadDNA.
English: 5 x 3 ml pre-filled pens 10 x 3 ml pre-filled pens 1 x 3 ml pre-filled pen + 7 NovoFine needles 1 x 3 ml pre-filled pen + 7 NovoTwist needles
Maltese: 1 x 3 ml pinna mimlija għal-lest 5 x 3 ml pinen mimlijin għal-lest 10 x 3 ml pinen mimlijin għal-lest 1 x 3 ml pinna mimlija għal-lest + 7 labar NovoFine 1 x 3 ml pinna mimlija għal-lest + 7 labar NovoTwist
English: Before opening: Store in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2°C-8°C).
English: DK-2880 Bagsværd, Denmark
Maltese: DK-2880 Bagsværd, Id--Danimarka
English: Modern insulin products are improved versions of human insulin.
Maltese: Prodotti moderni tal-insulina huma verżjonijiet aħjar ta' insulina umana.
English: +2 units
Maltese: +2 unitajiet
English: 3 ml suspension in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Maltese: Suspensjoni ta' 3 ml f'skartoċċ ( tal-ħġieġ tat-tip 1) bi planġer (bromobutyl) u b'għatu tal-lastku (bromobutyl/polyisoprene).
English: However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been investigated in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes.
Maltese: Madankollu, il-karatteristiċi farmakokinetiċi u farmakodinamiċi ta' insulin aspart li jinħall ġew investigati fit-tfal (6-12-il sena) u fl-adolexxenti (13-17-il sena ) bid-dijabete tat-tip 1.
English: See a) Summary of serious and very common side effects in section 4.
Maltese: Ara a) Sommarju ta' effetti sekondarji serji u komuni ħafna f'sezzjoni 4.
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (għall-aġġustament fil-pH) Sodium hydroxide (għall-aġġustament fil-pH)
English: FlexPen delivers 1-60 units in increments of 1 unit.
Maltese: FlexPen jista' jagħti minn 1-60 unità b'żidiet li jistgħu jkunu ta' unità waħda.
English: Insulin aspart is equipotent to human insulin on a molar basis.
Maltese: Insulin aspart hu ekwipotenti għall-insulina umana fuq bażi molari.
English: In a smaller (54 patients) and younger (age range 6 to 12 years) population, treated in a double-blind, cross-over trial (12 weeks on each treatment), the rate of hypoglycaemic episodes and the postprandial glucose increase were significantly lower with NovoMix 30 compared to biphasic human insulin 30.
Maltese: F'popolazzjoni iċken (54 pazjent) u ta' età iżgħar (etajiet bejn 6 u 12-il sena), ikkurati f'studju doubleblind u cross-over (12-il ġimgħa fuq kull kura), ir-rata ta' episodji ipogliċemiċi u ż-żieda taz-zokkor fid-demm wara l-ikel kienu b'mod sinifikanti inqas b'NovoMix 30 meta mqabbla ma' insulina umana 30 bifażika.
English: Uncommon - Oedema
Maltese: Mhux komuni - Edima
English: NovoMix 70 Penfill and NovoMix 70 FlexPen:
Maltese: NovoMix 70 Penfill u NovoMix 70 FlexPen:
English: 5 units selected
Maltese: Isselezzjonati 5 unitajiet
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti mniżżla f'sezzjoni 6.1.
English: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark
Maltese: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Id-Danimarka