FrancophonIA/ELRC3.0 huggingface dataset:
English: Eperzan contains the active ingredient albiglutide which belongs to a group of medicines called GLP-1 receptor agonists that are used to lower blood sugar (glucose) in adults with Type 2 diabetes.
Maltese: Eperzan fih is-sustanza attiva albiglutide li tagħmel parti minn grupp ta' mediċini msejħa agonisti tarriċettur GLP-1 li jintużaw biex ibaxxu z-zokkor fid-demm (glukożju) f'adulti bid-dijabete tat-tip 2.
English: • if you have ever had pancreatitis (inflammation of the pancreas).
Maltese: • jekk qatt kellek pankreatite (infjammazzjoni tal-frixa).
English: • severe stomach (abdominal) pain that does not go away, this can be a symptom of pancreatitis.
Maltese: • uġigħ sever fl-istonku (addominali) li ma jgħaddix, dan jista' jkun sintomu ta' pankreatite.
English: At Week 26, the mean daily dose of insulin glargine was 53 IU for Eperzan and 51 IU for lispro.
Maltese: Fil-Ġimgħa 26, id-doża medja ta' kuljum ta' insulin glargine kienet ta' 53 IU għal Eperzan u ta' 51 IU għal lispro.
English: Studies evaluated the use of Eperzan 30 mg and 50 mg once weekly, allowing for optional titration of Eperzan from 30 mg to 50 mg once weekly in 5 of the 8 studies.
Maltese: L-istudji vvalutaw l-użu ta' Eperzan 30 mg u 50 mg darba fil-ġimgħa, u ppermettew il-possibbiltà ta' titrazzjoni ta' Eperzan minn 30 mg għal 50 mg darba fil-ġimgħa f'5 mit-8 studji.
English: 4 pen needles
Maltese: 4 pinen 4 labar tal-pinen
English: 6b Hold pen upright, slowly twist the clear cartridge several times in the direction of the arrow until you feel/hear the pen “click” and you see the [3] in the number window (Figure O).
Maltese: 6b Żomm il-pinna dritta, bil-mod dawwar l-iskartoċċ ċar diversi drabi fid-direzzjoni tal-vleġġa sakemm tħoss/tisma' l-pinna “tikklikkja” u tara [3] fit-tieqa tan-numru (Figura O).
English: Treatment with Eperzan resulted in a mean weight loss for Eperzan (-0.7 kg) compared to a mean weight gain for insulin lispro (+0.8 kg) and the difference between treatment groups was statistically significant (see Table 6).
Maltese: Il-kura b'Eperzan wasslet għal tnaqqis medju fil-piż għal Eperzan (-0.7 kg) meta mqabbla ma' żieda medja fil-piż għal insulina lispro (+0.8 kg) u d-differenza bejn il-gruppi ta' kura kienet statistikament sinifikanti (ara Tabella 6).
English: The AUC of simvastatin acid was increased by 36% and Cmax was increased by approximately 100%.
Maltese: L-AUC tal-aċidu ta' simvastatin żdiedet b'36% u s-Cmax żdiedet b'madwar 100%.
English: Important warnings
Maltese: IMPORTANTI:
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Component of a multipack comprising 3 packs, each containing 4 pens and 4 pen needles Do not sell separately
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni Komponent ta' pakkett multiplu li fih 3 pakketti, kull wieħed fih 4 pinen u 4 labriet tal-pinen Tbiegħhomx separatament.
English: In the Phase III studies in type 2 diabetes patients, small increases in heart rate (1 to 2 bpm) were observed with albiglutide.
Maltese: Fl-istudji tal-Fażi III fuq pazjenti bid-dijabete tat-tip 2, kienu osservati żidiet żgħar fir-rata tal-qalb (1 sa 2 bpm) b'albiglutide.
English: Albiglutide delays gastric emptying, and has the potential to impact the absorption of concomitantly administered oral medicinal products.
Maltese: Albiglutide jittardja t-tbattil gastriku, u għandu l-potenzjal ta' impatt fuq l-assorbiment ta' prodotti mediċinali orali li jingħataw b'mod konkomitanti.
English: Trace levels of albiglutide were detected in plasma of offspring.
Maltese: Livelli traċċa ta albiglutide nstabu fil-plażma tal-frieħ.
English: 1b Check dosage and expiration date on pen (Figure E).
Maltese: 1b Iċċekkja d-dożaġġ u d-data ta' skadenza fuq il-pinna (Figura
English: Pen storage
Maltese: Labra tal-Pinna
English: Pneumonia occurred in 2% of patients receiving Eperzan compared to 0.8% of patients in the all comparators group.
Maltese: Pulmonite seħħet fi 2% tal-pazjenti li kienu qed jirċievu Eperzan meta mqabbla ma' 0.8% tal-pazjenti f'kull grupp ta' komparaturi.
English: 7a Choose your injection site (Figure P).
Maltese: 7a Agħżel is-sit tal-injezzjoni tiegħek (Figura P).
English: • chest infection (pneumonia)
Maltese: • infezzjoni fis-sider (pnewmonja)
English: Results at 52 weeks in an active-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to insulin glargine (titrated weekly per prescribing information) as addon therapy in patients inadequately controlled on metformin  sulfonylurea
Maltese: Ir-riżultati fil-ġimgħa 52 fi studju attiv-ikkontrollat li qabbel Eperzan 30 mg taħt il-ġilda filġimgħa (b'possibbiltà ta' titrazzjoni 'l fuq għal 50 mg kull ġimgħa) ma' insulina glargine (titrata fil-ġimgħa skont l-informazzjoni dwar il-preskrizzjoni) bħala terapija miżjuda f'pazjenti mhux ikkontrollati adegwatament fuq metformin  sulfonilurea
English: There were no albiglutide related findings in thyroids of monkeys given up to 50 mg/kg/week for up to 52 weeks (75 times clinical exposure based on AUC).
Maltese: Ma kien hemm ebda sejba relatati ma' albiglutide fit-tirojde ta' xadini li ngħataw sa 50 mg/k/ġimgħa għal 52 ġimgħa (75 darba l-espożizzjoni klinika abbażi tal-AUC).
English: A single carton of 4 pens and 4 needles may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use.
Maltese: Kartuna waħda ta' 4 pinen u 4 labriet tista' tinħażen f'temperatura ambjentali, li ma taqbiżx 30C, għal mhux aktar minn total ta' 4 ġimgħat qabel l-użu.
English: Complete dissolution for the 30 mg pen usually occurs within 2 minutes but may take up to 5 minutes, as confirmed by visual inspection for a clear solution free of particles.
Maltese: Xoljiment komplet għall-pinna ta' 30 mg normalment iseħħ fi żmien 2 minuti iżda jista' jieħu sa 5 minuti, kif ikkonfermat minn spezzjoni viżiva għal soluzzjoni ċara mingħajr frak.
English: Severe allergic reactions
Maltese: Reazzjonijiet allerġiċi serji
English: Tap Pen Cartridge
Maltese: Ara jekk tarax Frak
English: Treatment with Eperzan did not meet the pre-specified noninferiority margin (0.3%) against pioglitazone for HbA1c.
Maltese: Il-kura b'Eperzan ma ssodisfatx il-marġini speċifikat minn qabel ta' nuqqas ta' inferjorità (0.3%) kontra pioglitazone għall-HbA1c.
English: 3 Place pen into cup with clear cartridge pointing up (Figure I).
Maltese: Neħħi s-siġill mill-għatu ta' barra tal-labra (Figura L).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) -with blue box
Maltese: TIKKETTA TAT-TGEŻWIRA TA' BARRA - Pakkett multiplu li fih 12-il pinna ta' doża waħda u 12il labra tal-pinen (3 pakketti ta' 4 pinen u 4 labriet) - bil-kaxxa blu
English: Check Medicine
Maltese: Mediċini oħra u Eperzan
English: Sodium content This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, so is essentially ‘sodium free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodju (23 mg) f'kull doża ta' 0.5 ml, jiġifieri essenzjalment “ħieles mis-sodju”.
English: A statistically significant decrease in body weight was observed for Eperzan compared to an increase in body weight for insulin glargine and the difference in weight change was statistically significant (see Table 7).
Maltese: Tnaqqis statistikament sinifikanti fil-piż tal-ġisem kien osservat għal Eperzan meta mqabbel ma' żieda fil-piż tal-ġisem għall-insulina glargine u d-differenza fil-bidla fil-piż kienet statistikament sinifikanti (ara Tabella 7).
English: Experience in patients with severe renal impairment (<30 ml/min/1.73m2) or on dialysis is very limited and therefore Eperzan is not recommended in this population (see sections 4.4, 4.8, 5.1, 5.2).
Maltese: L-esperjenza f'pazjenti b'indeboliment renali sever (<30 ml/min/1.73m2) jew fuq dijalisi hija limitata ħafna u għalhekk Eperzan mhux rakkomandat f'din il-popolazzjoni (ara sezzjonijiet 4.4, 4.8, 5.1, 5.2).
English: Paediatric population: No pharmacokinetic data are available in paediatric patients.
Maltese: L-ebda dejta farmakokinetika ma hija disponibbli fuq pazjenti pedjatriċi.
English: Following SC administration of a single 30 mg dose to subjects with type 2 diabetes, maximum concentrations were reached 3 to 5 days post dose with mean peak albiglutide concentration (Cmax) of 1.74 mcg/ml and mean area under the time-concentration curve (AUC) of 465 mcg.h/ml.
Maltese: Wara l-għoti ta' doża unika ta' 30 mg taħt il-ġilda lil individwi bid-dijabete tat-tip 2, il-konċentrazzjonijiet massimi ntlaħqu 3 sa 5 ijiem wara l-għoti tad-doża b'konċentrazzjoni medja massima ta' albiglutide (Cmax) ta' 1.74 mcg/ml u erja medja taħt il-kurva għall-ħin-konċentrazzjoni (AUC) ta' 465 mcg.
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING CARTON - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles) - without blue box
Maltese: KARTUNA - Pakkett multiplu li fih 12-il pinna ta' doża waħda u 12-il labra tal-pinen (3 pakketti ta' 4 pinen u 4 labriet) - mingħajr il-kaxxa blu
English: Uncommon: may affect up to 1 in 100 people:
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna 1 minn kull 100:
English: Difference from glimepiride + metforminb , (95% CI) a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Maltese: Differenza minn glimepiride + metforminb, (95% CI) Proporzjon li laħqu HbA1c <7% Piż tal-Ġisem (kg)
English: Eperzan may be administered at any time of day without regard to meals.
Maltese: Dawn lavvenimenti kienu predominantement ħfief u ma wasslux għat-twaqqif.
English: Pen
Maltese: Pinna
English: Cardiovascular Evaluation:
Maltese: Kategorija farmakoterapewtika:
English: Water for injections
Maltese: Infezzjoni u infestazzjonijiet
English: Baseline (mean) Change at Week 52b
Maltese: Tibdil fil-Ġimgħa 52b
English: Based on the results of population pharmacokinetic analyses, there is no clinically relevant effect of gender on clearance.
Maltese: Dawn id-differenzi ma kinux meqjusa klinikament relevanti
English: Eperzan 30 mg powder and solvent for solution for injection Each pen delivers 30 mg albiglutide per 0.5 ml dose following reconstitution.
Maltese: - Is-sustanza attiva hija albiglutide Kull pinna ta' 30 mg tagħti 30 mg ta' albiglutide f'volum ta' 0.5 ml.
English: Eperzan 30 mg/50 mg Weekly + Metformin 1,500 mg daily
Maltese: 30 mg/50 mg Kull Ġimgħa + Metformin 1,500 mg kuljum
English: Step 1 Check pen
Maltese: 1 IĊĊEKKJA L-PINNA
English: Change at Week 52b Difference from placebob (95% CI)
Maltese: Linja bażi (medja) Tibdil fil-Ġimgħa 52b Differenza minn plaċebob (95% CI)
English: Count to 5
Maltese: Għodd sa 5
English: INFORMATION IN BRAILLE eperzan 50
Maltese: Kif taħżen Eperzan
English: Eperzan 50 mg powder and solvent for solution for injection Each pen delivers 50 mg albiglutide per 0.5 ml dose following reconstitution.
Maltese: - Is-sustanza attiva hija albiglutide Kull pinna ta' 50 mg tagħti 50 mg ta' albiglutide f'volum ta' 0.5 ml.
English: The risk of hypoglycaemia is increased when Eperzan is used in combination with insulin secretagogues (such as sulphonylurea) or with insulin.
Maltese: Ir-riskju ta' ipogliċemija jiżdied meta Eperzan jintuża flimkien ma' sekretagogi tal-insulina (bħal sulfonilurea) jew mal-insulina.
English: Breast-feeding
Maltese: TAL-PINNA
English: Results at 52 weeks in a placebo-controlled study with two doses of Eperzan (30 vs. 50 mg SC weekly) as monotherapy
Maltese: Ir-riżultati fil-ġimgħa 52 fi studju ikkontrollat bi plaċebo b'żewġ dożi ta' Eperzan (30 kontra 50 mg taħt il-ġilda fil-ġimgħa) bħala monoterapija
English: With the clear cartridge pointing up, gently swirl the pen for one minute.
Maltese: Huwa normali li tara bżieżaq tal-arja żgħar u xorta tista' tuża l-pinna.
English: Thyroid C-cell tumours were observed in 2 year rodent carcinogenicity studies with other GLP-1 receptor agonists.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the half-life of albiglutide (5 days).
Maltese: Jista' jkun meħtieġ perjodu twil ta' osservazzjoni u kura għal dawn is-sintomi b'kunsiderazzjoni tal-half-life ta' albiglutide (5 ijiem).
English: A meta-analysis of 9 clinical studies (8 major effectiveness studies and 1 phase II dose finding study) of up to 3 years duration was conducted to assess the cardiovascular safety of Eperzan (N=2,524) compared to all comparators (N=2,583) within these trials.
Maltese: II tas-sejbien tad-doża) li damu għaddejjin sa 3 snin saret biex tevalwa s-sigurtà kardjovaskulari ta' Eperzan (N=2,524) meta mqabbla mal-komparaturi kollha (N=2,583) f'dawn il-provi.
English: Posology
Maltese: Darbiet
English: Reductions in oestrous cycles were observed at 50 mg/kg/day, a dose associated with maternal toxicity (body weight loss and reduced food consumption).
Maltese: Tnaqqis fiċ-ċikli estruwi kien osservat f'50 mg/kg/kuljum, doża assoċjata ma' tossiċità materna (telf fil-piż tal-ġisem u tnaqqis fil-konsum tal-ikel).
English: These are rare in people taking Eperzan (may affect up to 1 in 1000 people).
Maltese: Dawn huma rari f'nies li jkunu qed jieħdu Eperzan (jistgħu jaffettwaw sa persuna 1 minn kull 1000).
English: Durham
Maltese: Siġill
English: 4b Check medicine through the viewing window.
Maltese: III ikkontrollati attivament u kkontrollati bi plaċebo.
English: Clear Cartridge✝
Maltese: Ara sezzjoni 4.
English: Offspring of mice dosed with 50 mg/kg/day during organogenesis had reduced weight during the pre-weaning period (which recovered after weaning), dehydration and coldness, and a delay in balanopreputial separation.
Maltese: Frieħ ta' ġrieden li ngħataw doża b'50 mg/kg/ kuljum matul l-organoġenesi kellhom tnaqqis fil-piż matul il-perjodu pre-ftim (li rkupra wara l-ftim), deidratazzjoni u kesħa, u dewmien fis-separazzjoni balanoprepuzjali.
English: Danmark GlaxoSmithKline Pharma A/S
Maltese: GlaxoSmithKline Pharmaceuticals s.a./n.v.
English: This removes the large air bubbles.
Maltese: Użu ta' darba biss.
English: DO NOT turn the cartridge to [3] (Step 6b) before attaching the needle (Step 5).
Maltese: IDDAWWARX l-iskartoċċ għal [3] (Pass 6b) qabel tweħħel il-labra (Pass 5).
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Maltese: Iżżewġ prodotti mediċinali qatt m'għadhom jitħalltu.
English: Remove Outer Needle Cap
Maltese: UŻATI JEW SKART MINN DAWN
English: Body weight has no clinically relevant effect on albiglutide AUC over the range 44 to 158 kg. A 20% increase in body weight resulted in an approximate 18.5% increase in clearance.
Maltese: Il-piż tal-ġisem ma għandu l-ebda effett klinikament rilevanti fuq l-AUC ta' albiglutide barra mill-firxa ta' 44 sa 158 kg.
English: Name and address of the manufacturer responsible for batch release:
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott:
English: Results at 26 weeks in a study of Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly if needed) versus sitagliptin (dosed according to renal function) in patients with different degrees of renal impairment
Maltese: Ir-riżultati fil-ġimgħa 26 ġimgħa fi studju ta' Eperzan 30 mg taħt il-ġilda fil-ġimgħa (b'titrazzjoni 'l fuq għal 50 mg fil-ġimgħa jekk meħtieġ) kontra sitagliptin (mogħti f'doża skont il-funzjoni renali) f'pazjenti bi gradi differenti ta' indeboliment renali
English: Tel: + 31 (0)30 6938100 nlinfo@gsk.com
Maltese: Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
English: Attach Needle
Maltese: Ir-Renju Unit
English: The primary endpoint was change in HbA1c from baseline at 52 weeks.
Maltese: L-endpoint primarju kien it-tibdil fl-HBA1c millinja bażi fil-ġimgħa 52.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Multipack:12 pens (3 cartons of 4 pens/4 needles) Do not sell separately
Maltese: Komponent ta' pakkett multiplu: 12-il pinna (3 pakketti, ta' 4 pinen/4 labriet tal-pinen) Tbiegħhomx separatament.
English: In pre- and postnatal development studies in mice administered albiglutide during pregnancy or while nursing, reduced pre-weaning body weight of F1 offspring was observed at 1 mg/kg/day (at exposures below clinical exposure).
Maltese: Fi studji tal-iżvilupp qabel u wara t-twelid fil-ġrieden li ngħataw albiglutide waqt it-tqala jew waqt ittreddigħ, tnaqqis fil-piż tal-ġisem qabel il-ftim tal-frieħ F1 kien osservat f'1 mg/kg/kuljum (f'espożizzjonijiet taħt l-espożizzjoni klinika).
English: a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Maltese: b Medja aġġustata c P<0.05 għad-differenza fil-kura
English: Risk of acute pancreatitis (an inflamed pancreas) Pancreatitis has been reported as an uncommon side effect.
Maltese: Riskju ta' pankreatite akuta (frixa infjammata)
English: Follow instructions to twist the cartridge until ‘2' appears in the number window and a “click” is heard.
Maltese: Jekk ma tismax “klikk” meta [2] jew meta [3] jimxi fit-tieqa tan-numru, jaf ma jkollokx in-numru fin-nofs għalkollox fit-tieqa.
English: In reproductive toxicology studies with albiglutide in mice, there were no effects on mating or fertility at doses up to 50 mg/kg/day (at low multiple of clinical exposure).
Maltese: Fi studji tossikoloġiċi fuq ir-riproduttiva b'albiglutide fil-ġrieden, ma kien hemm l-ebda effetti fuq ittgħammir jew fuq il-fertilità f'dożi sa 50 mg/kg/kuljum (f'multiplu baxx ta' espożizzjoni klinika).
English: • A container for pen disposal.
Maltese: • Kontenitur għar-rimi tal-pinna.
English: Change at Week 26b Difference from sitagliptinb (95% CI)
Maltese: Linja bażi (medja) Tibdil fil-Ġimgħa 26b Differenza minn sitagliptinb (95%
English: Similar exposure is achieved with SC administration of albiglutide in the abdomen, thigh, or upper arm.
Maltese: Espożizzjoni simili tinkiseb bl-għoti ta' albiglutide taħt il-ġilda fl-addome, fil-koxxa, jew fil-parti ta' fuq tad-driegħ.
English: IMPORTANT: Make sure you have waited 30 minutes before continuing onto step 4.
Maltese: Żgura li tistenna 30 minuta qabel tkompli għal Pass 4.
English: Packaging Content Package size
Maltese: Kif jingħata Ippakkjar Kontenut Daqs talpakkett
English: Target species
Maltese: Perjodu ta' tiżmim
English: Whereas
Maltese: Pożoloġija
English: Module 3 - Quality
Maltese: Modulu 3 - Kwalità
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC;
Maltese: • Il-Kumitat ikkunsidra r-referenza skont l-Artikolu 30 tad-Direttiva 2001/83/KE;
English: Scandonest contains 30 mg/mL of mepivacaine hydrochloride.
Maltese: Scandonest fih 30 mg/mL ta' kloridat ta' mepivacaine.
English: The maximum recommended dose is 4.4 mg/kg of body weight with an absolute maximum recommended dose of 300 mg.
Maltese: Id-doża massima rakkomandata hija ta' 4.4 mg/kg tal-piż tal-ġisem b'doża rakkomandata massima assoluta ta' 300 mg.
English: The updated sections of Module 3 sections include: Active substance, Control of active substance, Specification, Finished product, Description and composition of the finished substance, Manufacture, Description of manufacturing process and process controls, Process validation and/or evaluation, Control of Excipients, Control of Finished substance, Specifications, Analytical procedures, Container Closure System and Stability.
Maltese: Sustanza attiva, Kontroll tas-sustanza attiva, Speċifikazzjoni, Prodott finali, Deskrizzjoni u kompożizzjoni tassustanza finali, Manifattura, Deskrizzjoni tal-proċess ta' manifattura u kontrolli tal-proċess, Validazzjoni u/jew evalwazzjoni tal-proċess, Kontroll tal-Eċċipjenti, Kontroll tas-Sustanza finali, Speċifikazzjonijiet, Proċeduri analitiċi, Sistema ta' Għeluq u Stabbiltà tal-Kontenitur.
English: In the EU, Scandonest is authorised in 22 Member States (MS) through national procedures, and in 5 MSs (Sweden, Finland, Portugal, Spain, Malta) through mutual recognition procedure (MRP).
Maltese: Fl-UE, Scandonest huwa awtorizzat fi 22 Stat Membru (MS) permezz ta' proċeduri nazzjonali, u f'5 MSs (l-Iżvezja, il-Finlandja, il-Portugall, Spanja, Malta) permezz ta' proċedura ta' rikonoxximent reċiproku (MRP).
English: Interactions with other medicinal products (section 4.5) have been summarised in additive interactions with other local anaesthetics, H2 antihistaminics, sedatives, antiarrhythmic drugs, CYP1A2 inhibitors and propranolol.
Maltese: L-interazzjonijiet ma' prodotti mediċinali oħra (sezzjoni 4.5) inġabru fil-qosor f'interazzjonijiet addittivi ma' anestetiċi lokali oħra, H2, antiistamini, sedattivi, mediċini antiaritmiċi, inibituri ta' CYP1A2 u propranolol.
English: Sections 2 (qualitative and quantitative composition), 3 (pharmaceutical form), 4.7 (Effects on ability to drive and use machines), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties), 6.1 (list of excipients), 6.2 (incompatibilities), 6.3 (shelf life), 6.4 (special precautions for storage) 6.5 (nature and contents of container) and 6.6 (Special precautions for disposal and other handling) have been updated in line with their respective harmonised Quality documentation provided in module 3 and in line with the latest QRD template.
Maltese: Sezzjonijiet 2 (għamla kwalitattiva u kwantitattiva), 3 (għamla farmaċewtika), 4.7 (Effetti fuq il-ħila biex issuq u tħaddem magni), 5.1 (proprjetajiet farmakodinamiċi), 5.2 (proprjetajiet farmakokinetiċi), 6.1 (lista ta' eċċipjenti), 6.2 (inkompatibbiltajiet), 6.3 (żmien kemm idum tajjeb il-prodott mediċinali), 6.4 (prekawzjonijiet speċjali għall-ħażna), 6.5 (in-natura tal-kontenitur u ta' dak li hemm ġo fih) u 6.6 (prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor) ġew aġġornati f'konformità maddokumentazzjoni tal-Kwalità armonizzata rispettiva tagħhom ipprovduta f'modulu 3 u f'konformità malaħħar mudell tal-QRD.
English: In section 4.9 regarding overdose, two different types are described; absolute and relative overdose.
Maltese: F'sezzjoni 4.9 dwar doża eċċessiva, hemm deskritti żewġ tipi differenti, doża eċċessiva assoluta u relattiva.
English: The recommended posology in children of an average 0.75 mg (0.025 ml) of mepivacaine solution per kg of body weight is in line with the work-sharing procedure led by EMA in 2010 in accordance with Article 45 of the Paediatric Regulation 1901/2006 (AT/W/0002/pdWS/001).
Maltese: Il-pożoloġija rakkomandata fit-tfal ta' soluzzjoni medja ta' mepivacaine ta' 0.75 mg (0.025 ml) għal kull kg tal-piż tal-ġisem hija f'konformità mal-proċedura tal-kondiviżjoni ta' xogħol li tmexxiet mill-EMA fl-2010 skont l-Artikolu 45 tar-Regolament Pedjatriku 1901/2006 (AT/W/0002/pdWS/001).
English: Grounds for the CHMP opinion
Maltese: Raġunijiet għall-opinjoni tas-CHMP Billi
English: The CHMP is of the opinion that in case of vasoconstrictor contraindication there are alternative options, such as other local anaesthetics (procaine, bupivacaine and lidocaine), general anaesthesia and nitrous oxide.
Maltese: Is-CHMP huwa tal-fehma li fil-każ tal-kontraindikazzjoni tal-vażokostrittur hemm għażliet alternattivi, bħal anestetiċi lokali oħra (procaine, bupivacaine u lidocaine), anesteżija ġenerali u ossidu nitruż.
English: Local anaesthetics as cardiovascular depressants exert a negative inotropic and chronotropic effect on the myocardium and produce peripheral vasodilation.
Maltese: Anestetiċi lokali bħal dipressanti kardjovaskulari joħolqu effett inotropiku u kronotropiku negattiv fuq ilmijokardiku u jipproduċu vażodilazzjoni periferali.
English: The MAH has provided a summary of the literature and studies to support the indication “anaesthesia in dental procedures”.
Maltese: L-MAH ipprovda sommarju tal-letteratura u studji sabiex jappoġġja l-indikazzjoni "anesteżija fi proċeduri dentali".