FrancophonIA/ELRC3.0 huggingface dataset:
English: This was shown with a single dose of 0.5 mg semaglutide for patients with different degrees of renal impairment (mild, moderate, severe or patients in dialysis) compared with subjects with normal renal function.
Maltese: Dan intwera b'doża waħda ta' 0.5 mg ta' semaglutide għal pazjenti bi gradi differenti ta' indeboliment renali (ħafif, moderat, sever, jew pazjenti fuq id-dijalisi) meta mqabbla ma' individwi b'funzjoni renali normali.
English: Hypoglycaemiaa when used with other OADs
Maltese: Ipogliċemija a meta jintuża ma' OADs oħrajn
English: Each dose contains 1 mg of semaglutide in 0.74 ml.
Maltese: Kull doża fiha 1 mg ta' semaglutide f'0.74 ml.
English: This makes sure that the solution flows.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: 1 pre-filled pen and 4 disposable NovoFine Plus needles 3 pre-filled pens and 12 disposable NovoFine Plus needles
Maltese: Pinna 1 mimlija għal-lest u 4 labar NovoFine Plus li jintremew wara li jintużaw 3 pinen mimlijin għal-lest u 12-il labra NovoFine Plus li jintremew wara li jintużaw
English: In a 56-week open-label trial, 813 patients on metformin alone (49%), metformin with sulfonylurea (45%) or other (6%) were randomised to Ozempic 1 mg or exenatide ER 2 mg once weekly.
Maltese: Fi prova open-label li damet 56-ġimgħa, 813-il pazjent fuq metformin waħdu (49%), metformin ma' sulfonylurea (45%) jew xi ħaġa oħra (6%), intgħażlu b'mod każwali biex jieħdu Ozempic 1 mg jew exenatide ER 2 mg darba kull ġimgħa.
English: In cardiovascular high risk population the adverse reaction profile was similar to that seen in the other phase 3a trials (described in section 5.1).
Maltese: Prova ta' sentejn dwar riżultati kardjovaskulari u s-sigurtà Fil-popolazzjoni b'riskju għoli kardjovaskulari, il-profil tar-reazzjonijiet avversi kien simili għal dak osservat fil-provi l-oħrajn ta' fażi 3a (deskritt f'sezzjoni 5.1).
English: Rough handling or misuse may cause inaccurate dosing.
Maltese: Semaglutide ma affettwax ilfertilità f'firien irġiel.
English: Each pen contains 3 ml solution, delivering 4 doses of 1 mg.
Maltese: Kull pinna fiha 3 ml ta' soluzzjoni, li tforni 4 dożi ta' 1 mg.
English: The proportion of patients tested positive for anti-semaglutide antibodies at any time point post-baseline was low (1−2%) and no patients had anti-semaglutide neutralising antibodies or anti-semaglutide antibodies with endogenous GLP-1 neutralising effect at end-of-trial.
Maltese: Il-proporzjon ta' pazjenti li kellhom riżultat pożittiv għal antikorpi kontra semaglutide fi kwalunkwe punt ta' ħin warra l-linja bażi kien baxx (1−2%), u l-ebda pazjenti ma kellhom antikorpi newtralizzanti kontra semaglutide jew antikorpi kontra semaglutide b'effett newtralizzanti GLP-1 endoġenu fit-tmiem talprova.
English: Change from baseline at week 30 Difference from placebo [95% CI]
Maltese: Differenza mill-plaċebo [95% CI]
English: In foetuses, major skeletal and visceral malformations were observed, including effects on long bones, ribs, vertebrae, tail, blood vessels and brain ventricles.
Maltese: Fil-feti, malformazzjonijiet skeletriċi u vixxerali maġġuri ġew osservati, li jinkludu effetti fuq l-għadam it-twil, kustilji, vertebri, fid-denb, vini u arterji u fil-ventrikoli tal-moħħ.
English: Each dose contains 0.25 mg of semaglutide in 0.19 ml solution.
Maltese: Kull doża fiha 0.25 mg ta' semaglutide f'0.19 ml ta' soluzzjoni.
English: 1 pen and 4 disposable needles (4 doses) 3 pens and 12 disposable needles (12 doses)
Maltese: Pinna 1 u 4 labar li jintremew wara li jintużaw (4 dożi) 3 pinen u 12-il pinna li jintremew wara li jintużaw (12-il doża)
English: Count slowly:
Maltese: Waqt l-użu:
English: Semaglutide is not recommended for use in patients with end-stage renal disease (see section 5.2).
Maltese: Semaglutide mhuwiex irrakkomandat għal pazjenti b'mard renali fl-aħħar stadju (ara sezzjoni 5.2).
English: In this trial, adjudicated events of diabetic retinopathy complications occurred in more patients treated with semaglutide (3.0%) compared to placebo (1.8%).
Maltese: F'din il-prova, avvenimenti aġġudikati ta' kumplikazzjonijiet ta' retinopatija dijabetika seħħew f'aktar pazjenti kkurati b'semaglutide (3.0%) meta mqabbla mal-plaċebo (1.8%).
English: Dose counter Dose pointer
Maltese: Kontatur tad-doża Indikatur tad-doża
English: Semaglutide did not change the overall exposure of atorvastatin following a single dose administration of atorvastatin (40 mg).
Maltese: Semaglutide ma bidilx l-espożizzjoni totali ta' atorvastatin wara l-għoti ta' doża waħda ta' atorvastatin (40 mg).
English: Semaglutide lowers the fasting and postprandial glucagon concentrations.
Maltese: Semaglutide inaqqas il-konċentrazzjonijiet tal-glucagon fl-istat sajjem u wara ikla.
English: Change from baseline
Maltese: Ż-ŻGĦAR EWLENIN
English: In clinical trials up to 1 year involving 4,807 patients with type 2 diabetes, adverse events related to diabetic retinopathy were reported in similar proportions of subjects treated with semaglutide (1.7%) and comparators (2.0%).
Maltese: Fi provi kliniċi li damu sa sena li kienu jinvolvu 4,807 pazjenti b'dijabete ta' tip 2, avvenimenti avversi relatati ma' retinopatija dijabetika kienu rrappurtati fi proporzjonijiet simili ta' individwi kkurati b'semaglutide (1.7%) u l-komparaturi
English: -3.6c [-4.3, -2.8]a p <0.0001 (2-sided) for superiority b
Maltese: [-4.3, -2.8]a ap <0.
English: Higher body weight results in lower exposure; a 20% difference in body weight between individuals will result in an approximate 16% difference in exposure.
Maltese: Piż tal-ġisem ogħla jirriżulta f'espożizzjoni aktar baxxa; differenza ta' 20% fil-piż tal-ġisem bejn l-individwi se tirriżulta f'differenza approssimattiva ta' 16% fl-espożizzjoni.
English: Each dose contains 0.5 mg of semaglutide in 0.37 ml solution.
Maltese: Kull doża fiha 0.5 mg ta' semaglutide f'0.37 ml ta' soluzzjoni.
English: Increased heart rate has been observed with GLP-1 receptor agonists.
Maltese: Ġiet osservata żieda fir-rata tal-qalb bl-agonisti tar-riċettur GLP-1.
English: A drop of solution should appear at the needle tip.
Maltese: Id-differenza fil-kura dehret kmieni u baqgħet tul il-prova kollha.
English: The reactions are listed below by system organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt, skont is-sistema tal-klassifika tal-organi u lfrekwenza assoluta.
English: There were 158 events of new or worsening nephropathy.
Maltese: Kien hemm 158 avveniment ta' nefropatija ġdida jew li qed taggrava.
English: One pre-filled pen contains 2 mg semaglutide in 1.5 ml solution.
Maltese: Pinna 1 mimlija għal-lest fiha 2 mg ta' semaglutide f'1.5 ml ta' soluzzjoni.
English: MARKETING AUTHORISATION NUMBERS EU/1/17/1251/003 1 pen and 4 disposable needles EU/1/17/1251/004 3 pens and 12 disposable needles
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1251/ 003 pinna 1 u 4 labar li jintremew wara li jintużaw EU/1/17/1251/ 004 3 pinen u 12-il labra li jintremew wara li jintużaw
English: • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
Maltese: • bħala monoterapija meta metformin huwa kkonsidrat li mhuwiex adattat minħabba xi intolleranza jew kontraindikazzjonijiet
English: SUSTAIN 5 - Ozempic vs. placebo both in combination with basal insulin In a 30-week double-blind placebo-controlled trial, 397 patients inadequately controlled with basal insulin with or without metformin were randomised to Ozempic 0.5 mg once weekly, Ozempic 1 mg once weekly or placebo.
Maltese: Fi prova kkontrollata bi plaċebo li damet 30 ġimgħa, double-blind, 397 pazjent li ma kinux ikkontrollati b'mod adegwat permezz ta'insulina bażali, bi jew mingħajr metformin, intgħażlu b'mod każwali biex jieħdu Ozempic 0.5 mg, Ozempic 1 mg darba kull ġimgħa, jew plaċebo.
English: -4.2 [-4.9, -3.5]a ap <0.0001 (2-sided) for superiority
Maltese: .2 [-4.9, -3.5]a p <0.
English: When Ozempic is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued unchanged.
Maltese: Meta Ozempic jiżdied ma' terapija eżistenti b'metformin u/jew thiazolidinedione, id-doża kurrenti ta' metformin u/jew thiazolidinedione tista' titkompla mingħajr tibdil.
English: Flow check symbol
Maltese: Simbol u talverifika tal-fluss
English: Needle
Maltese: Sturdament
English: MARKETING AUTHORISATION NUMBERS EU/1/17/1251/005 1 pen and 4 disposable needles EU/1/17/1251/006 3 pens and 12 disposable needles
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1251/ 005 pinna 1 u 4 labar li jintremew wara li jintużaw EU/1/17/1251/ 006 3 pinen u 12-il labra li jintremew wara li jintużaw
English: Similar exposure was achieved with subcutaneous administration of semaglutide in the abdomen, thigh, or upper arm. Absolute bioavailability of subcutaneous semaglutide was 89%.
Maltese: Il-bijodisponibilità assoluta ta' semaglutide mogħti taħt il-ġilda kienet ta' 89%.
English: Systematic evaluation of diabetic retinopathy complication was only performed in the cardiovascular outcomes trial.
Maltese: Evalwazzjoni sistematika tal-kumplikazzjoni tar-retinopatija dijabetika saret biss fil-prova dwar ir-riżultati kardjovaskulari.
English: In 2-year carcinogenicity studies in rats and mice, semaglutide caused thyroid C-cell tumours at clinically relevant exposures.
Maltese: Pazjenti b'piż baxx tal-ġisem jistgħu jesperjenzaw aktar effetti sekondarji gastrointestinali meta jiġu kkurati b'semaglutide.
English: In a 104-week double-blind trial (SUSTAIN 6), 3,297 patients with type 2 diabetes mellitus at high cardiovascular risk were randomised to either Ozempic 0.5 mg once weekly, Ozempic 1 mg once weekly or corresponding placebo in addition to standard-of-care hereafter followed for 2 years.
Maltese: Fi prova double-blind li damet 104 ġimgħa (SUSTAIN 6), 3,297 pazjent b'dijabete mellitus ta' tip 2 f'riskju kardjovaskulari għoli, intgħażlu b'mod każwali biex jieħdu jew Ozempic 0.5 mg darba kull ġimgħa, Ozempic 1 mg darba kull ġimgħa, jew plaċebo korrispondenti, flimkien ma' standard ta' kura wara għal sentejn.
English: This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Maltese: Dan jista' jevita labar imblukkati, kontaminazzjoni, infezzjoni, tnixxija ta' soluzzjoni u dożaġġ mhux preċiż.
English: -5.1 [-6.1, -4.0]a p <0.0001 (2-sided) for superiority
Maltese: [-6.1, -4.0]a ap <0.
English: Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop antibodies following treatment with semaglutide.
Maltese: Konsistenti mal-fatt li prodotti mediċinali li fihom il-proteini u l-peptides jista' jkollhom karatteristiċi immunoġeniċi, il-pazjenti jistgħu jiżviluppaw antikorpi wara l-kura b'semaglutide.
English: This is especially important if you have kidney problems.
Maltese: Dan huwa speċjalment importanti jekk għandek problemi tal-kliewi.
English: Compared to placebo, semaglutide improved first- and second-phase insulin response with a 3- and 2-fold increase, respectively, and increased maximal beta-cell secretory capacity in patients with type 2 diabetes.
Maltese: Meta mqabbel mal-plaċebo, semaglutide tejjeb irrispons tal-ewwel u t-tieni fażi tal-insulina b'żieda ta' 3 darbiet u darbtejn, rispettivament, u żied ilkapaċità massima tas-sekrezzjoni taċ-ċelluli beta f'pazjenti b'dijabete ta' tip 2.
English: In total 98% of the patients completed the trial and the vital status was known at the end of the trial for 99.6% of the patients.
Maltese: B'kollox, 98% tal-pazjenti temmew il-prova, u l-istat vitali kien magħruf sal-aħħar tal-prova għal 99.6% tal-pazjenti.
English: How to store Ozempic
Maltese: Meta gћandek tuża Ozempic
English: Semaglutide delays the rate of gastric emptying as assessed by paracetamol pharmacokinetics during a standardised meal test. Paracetamol AUC0-60min and Cmax were decreased by 27% and 23%, respectively, following concomitant use of semaglutide 1 mg.
Maltese: L-AUC ta' paracetamol0-60 minuta u s-Cmax naqsu b'27% u 23%,
English: 0.25 mg selected
Maltese: Isselezzjonat 0.25 mg
English: • Take a new needle and tear off the paper tab.
Maltese: • Iċċekkja li s-soluzzjoni fil-pinna tiegħek tkun ċara u bla kulur.
English: The efficacy and safety of Ozempic 0.5 mg and 1 mg once weekly were evaluated in six randomised controlled phase 3a trials that included 7,215 patients with type 2 diabetes mellitus (4,107 treated with semaglutide).
Maltese: L-effikaċja u s-sigurtà ta' Ozempic 0.5 mg u 1 mg darba kull ġimgħa, ġew evalwati f'sitt provi kkontrollati ta' fażi 3a, li fihom il-parteċipanti ntgħażlu b'mod każwali, li kienu jinkludu 7,215-il pazjent b'dijabete mellitus ta' tip 2 (4,107 ikkurati b'semaglutide).
English: The mean volume of distribution of semaglutide following subcutaneous administration in patients with type 2 diabetes was approximately 12.5 L. Semaglutide was extensively bound to plasma albumin
Maltese: Il-volum medju tad-distribuzzjoni ta' semaglutide wara l-għoti taħt il-ġilda f'pazjenti b'dijabete ta' tip 2 kien ta' madwar 12.5 L. Semaglutide weħel b'mod estensiv mal-albumina fil-plażma (>99%).
English: However, a direct effect of semaglutide on the foetus cannot be excluded.
Maltese: Madankollu, effett dirett ta' semaglutide fuq il-fetu ma jistax jiġi eskluż.
English: Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood sugar levels (hypoglycaemia).
Maltese: Li tikkombina sulfonylurea jew insulina ma' din il-mediċina, jista' jżid ir-riskju li jkollok livelli baxxi ta' zokkor fid-demm (ipogliċemija).
English: Only the dose counter and dose pointer will show that 1 mg has been selected.
Maltese: Il-kontatur tad-doża u l-indikatur tad-doża biss se juruk li sselezzjonajt 1 mg.
English: • low blood sugar (hypoglycaemia) when this medicine is used with another antidiabetic medicine
Maltese: • livell baxx ta' zokkor fid-demm (ipogliċemija) meta din il-mediċina tintuża ma' mediċina oħra kontra d-dijabete
English: • inflamed stomach (‘gastritis') - the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
Maltese: • stonku infjammat (‘gastrite') - is-sinjali jinkludu wġigħ fl-istonku, tħossok imdardar (nawseja)
English: No episodes of severe hypoglycaemia were observed when semaglutide was used as monotherapy.
Maltese: Ma ġie osservat ebda episodju ta' ipogliċemija severa meta semaglutide intuża waħdu.
English: Semaglutide caused a minor delay of early postprandial gastric emptying, thereby reducing the rate at which glucose appears in the circulation postprandially.
Maltese: Titjib malajr filkontroll tal-glucose ġie assoċjat ma' aggravament temporanju ta' retinopatija dijabetika iżda ma jistgħux jiġu esklużi mekkaniżmi oħra.
English: Each dose contains 1 mg of semaglutide in 0.74 ml solution.
Maltese: Kull doża fiha 1 mg ta' semaglutide f'0.74 ml ta' soluzzjoni.
English: Pregnancy
Maltese: Dulaglutide
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Ozempic 0.25 mg injection semaglutide subcutaneous use
Maltese: Ozempic 0.25 mg injezzjoni semaglutide użu għal taħt il-ġilda
English: Inner needle cap
Maltese: Bidla mil-linja bażi
English: This should be considered when treating patients, with impaired renal function as nausea, vomiting, and diarrhoea may cause dehydration which could cause a deterioration of renal function (see section 4.8).
Maltese: Dan għandu jiġi kkunsidrat meta wieħed ikun qed jikkura l-pazjenti b'funzjoni renali indebolita bħal dardir, rimettar, u dijarea, li jistgħu jikkawżaw deidratazzjoni li tista' tikkawża deterjorament tal-funzjoni renali (ara sezzjoni 4.8).
English: • dizziness
Maltese: • għeja
English: Treatment with semaglutide resulted in a 26% risk reduction in the primary composite outcome of death from cardiovascular causes, non-fatal myocardial infarction or non-fatal stroke.
Maltese: Il-kura b'semaglutide irriżultat fi tnaqqis ta' 26% fir-riskju fir-riżultat talkompost primarju ta' mewt minn kawżi kardjovaskulari, infart mijokardijaku li ma jkunx fatali jew attakk ta' puplesija li ma tkunx fatali.
English: Ozempic pre-filled pen and needle (example)
Maltese: Ozempic pinna mimlija għallest u labra (eżempju)
English: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Denmark
Maltese: Linja bażi (medja) Bidla mil-linja bażi fl-40 ġimgħa
English: Pack size
Maltese: Il-Pakkett li jmiss malprodott
English: NeuroBloc (botulinum toxin type B) EMA/356522/2018
Maltese: NeuroBloc (tossina ta' botulinju tip B) EMA/356522/2018
English: Further information on NeuroBloc can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Aktar informazzjoni fuq NeuroBloc tinstab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about NeuroBloc
Maltese: Informazzjoni oħra dwar NeuroBloc
English: NeuroBloc received a marketing authorisation valid throughout the EU on 22 January 2001.
Maltese: NeuroBloc irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU fit-22 ta' Jannar 2001.
English: NeuroBloc (botulinum toxin type B)
Maltese: NeuroBloc (tossina ta' botulinju tip B)
English: The active substance in NeuroBloc, botulinum toxin type B, is a well-known toxic substance produced by the bacterium Clostridium botulinum.
Maltese: Is-sustanza attiva f'NeuroBloc, tossina ta' botulinju tip B, hija sustanza tossika magħrufa sew prodotta mill-batterju Clostridium botulinum.
English: NeuroBloc was more effective than placebo (a dummy treatment) at improving symptoms of cervical dystonia in four studies involving a total of 392 adults.
Maltese: Neurobloc kien aktar effettiv mill-plaċebo (kura finta) biex itejjeb is-sintomi ta' distonja ċervikali f'erba' studji li involvew total ta' 392 adult.
English: NeuroBloc contains the active substance botulinum toxin type B.
Maltese: NeuroBloc fih is-sustanza attiva tossina ta' botulinju tip B.
English: The most common side effects with NeuroBloc (which may affect more than 1 in 10 people) are dry mouth, headache (in patients new to treatment with botulinum toxins), dysphagia (difficulty swallowing) and pain at the site of the injection.
Maltese: L-effetti sekondarji l-aktar komuni b'NeuroBloc (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma ħalq xott, uġigħ ta' ras (f'pazjenti li ma rċevewx kura b'tossini ta' botulinju qabel), bligħ anormali (diffikultà biex tibla') u uġigħ fis-sit tal-injezzjoni.
English: What are the risks associated with NeuroBloc?
Maltese: X'inhuma r-riskji assoċjati ma' NeuroBloc?
English: Acetylcholine is needed to transfer electrical impulses from the nerves to the muscles in order for the muscles to contract.
Maltese: L-aċetilkolina hija meħtieġa biex tittrasferixxi impulsi elettriċi minnervituri għall-muskoli sabiex ikun hemm kontrazzjoni tal-muskoli.
English: How is NeuroBloc used?
Maltese: NeuroBloc?
English: For the full list of side effects reported with NeuroBloc, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati bi NeuroBloc, ara l-fuljett ta' tagħrif.
English: When injected directly into a muscle it reduces the release of acetylcholine and muscle contraction in the affected neck or shoulder muscles, thereby relieving the patient's symptoms.
Maltese: Meta jiġi injettat direttament ġo muskolu, dan inaqqas ir-rilaxx tal-aċetilkolina u l-kontrazzjoni tal-muskolu fil-muskoli affettwati tal-għonq jew tal-ispalla, b'hekk itaffi s-sintomi tal-pazjent.
English: Effectiveness was measured by looking at the change in symptoms (severity, pain and disability) after four weeks, measured using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).
Maltese: L-effikaċja tkejlet billi ngħatat ħarsa lejn il-bidla fissintomi (severità, uġigħ u diżabilità) wara erba' ġimgħat, imkejla permezz tal-Iskala ta' Klassifikazzjoni ta' Tortikollis Spażmodika ta' Toronto tal-Punent (TWSTRS, Toronto Western Spasmodic Torticollis Rating Scale).
English: As for all medicines, data on the use of NeuroBloc are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' NeuroBloc hija ssorveljata kontinwament.
English: NeuroBloc is a medicine used to treat cervical dystonia in adults.
Maltese: NeuroBloc huwa mediċina li tintuża biex tikkura distonja ċervikali fl-adulti.
English: NeuroBloc is available as a solution for injection (5,000 units [U] per millilitre) and it can only be obtained with a prescription.
Maltese: NeuroBloc jiġi bħala soluzzjoni għall-injezzjoni (5,000 unità [U] għal kull millilitru) u dan jista' jinkiseb biss b'riċetta ta' tabib.
English: Side effects reported with NeuroBloc are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati bi NeuroBloc huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Cervical dystonia, which is also known as torticollis, is a disorder when the neck muscles contract, causing abnormal movement and twisting of the neck and unusual positioning of the head.
Maltese: Distonja ċervikali, li hija magħrufa wkoll bħala tortikollis, hija disturb meta jiċkienu l-muskoli tal-għonq, b'hekk jikkawżaw moviment u tidwir anormali tal-għonq u pożizzjonament mhux tas-soltu tar-ras.
English: In NeuroBloc, the toxin is used as a muscle relaxant.
Maltese: F'NeuroBloc, it-tossina tintuża bħala rilassant għall-muskolu.
English: NeuroBloc must not be used in patients with other neuromuscular (nerve and muscle) disorders.
Maltese: NeuroBloc m'għandux jintuża f'pazjenti b'disturbi newromuskolari (nerv u muskolu) oħra.
English: Most patients who had a response to NeuroBloc by the fourth week had returned to their original condition 12 to 16 weeks after the injection.
Maltese: Il-biċċa l-kbira tal-pazjenti li kellhom rispons għal NeuroBloc sar-raba' ġimgħa kienu rritornaw għall-kondizzjoni oriġinali tagħhom 12 sa 16-il ġimgħa wara linjezzjoni.
English: Three of the studies included patients who had stopped responding to type A botulinum toxin (another type of botulinum toxin that may also be used to treat cervical dystonia), and the fourth only included patients who did respond to type A toxin.
Maltese: Tlieta mill-istudji inkludew pazjenti li kienu waqfu jirrispondu għal tossina ta' botulinju tip A (tip ieħor ta' tossina ta' botulinju li wkoll tista' tintuża biex tikkura distonja ċervikali), u r-raba' studju inkluda biss pazjenti li rrispondew għal tossina tip A.
English: The toxin is the cause of a type of food poisoning called botulism, where patients suffer from muscle weakness and paralysis.
Maltese: It-tossina hija l-kawża ta' tip ta' avvelenament mill-ikel imsejjaħ botuliżmu, fejn il-pazjenti jbatu minn dgħufija u paraliżi tal-muskoli.
English: London, 26 April 2007 Doc.
Maltese: Londra, 26 ta' April 2007 Dok. Ref.
English: International non-proprietary name (INN): mecasermin rinfabate
Maltese: Mhux Patentat (INN): mecasermin rinfabate
English: Ref. EMEA/111199/2007
Maltese: EMEA/231350/2007
English: What is IPLEX?
Maltese: X'inhu IPLEX?
English: The active substance in IPLEX, mecasermin rinfabate, is a binary protein made up of two proteins that are normally produced by the body: insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3).
Maltese: Is-sustanza attiva f'IPLEX, mecasermin rinfabate, hija proteina binarja magħmula minn żewġ proteini li normalment huma prodotti mill-ġisem: insulin-like growth factor I (IGF-I) u insulin-like growth factor binding protein 3 (IGFBP-3).
English: IPLEX is a solution for injection containing 60 mg/ml mecasermin rinfabate as the active substance.
Maltese: IPLEX hu soluzzjoni għall-injezzjoni li fiha 60 mg/ml mecasermin rinfabate bħala s-sustanza attiva.
English: Mecasermin rinfabate is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA), which makes them able to produce it.
Maltese: Mecasermin rinfabate jiġi prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': jiġi prodott minn batterji li jkunu rċevew ġene (DNA), li jagħmilha possibbli li jipproduċuha.