FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP decided that Nexavar's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Sabiex jiġu kkontrollati l-effetti sekondarji, jista' jkun hemm bżonn li l-kura titwaqqaf temporanjament jew inkella li d-doża titnaqqas.
English: What is the risk associated with Nexavar?
Maltese: X'inhu r-riskju assoċjat ma' Nexavar?
English: This finding was based on the results from all 903 patients, including about 200 who had switched from placebo to Nexavar before the end of the study.
Maltese: Din is-sejba kienet ibbażata fuq ir-riżultati tad-903 pazjenti kollha kemm huma, inklużi madwar 200 li qalbu minn plaċebo għal Nexavar qabel ittmiem tal-istudju.
English: For the full list of all side effects and restrictions with Nexavar, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Nexavar, ara l-fuljett ta' tagħrif.
English: In the study of hepatocellular carcinoma, the patients taking Nexavar survived for an average of 10.7 months, compared with 7.9 months in those taking placebo.
Maltese: Din is-sejba kienet ibbażata fuq ir-riżultati ta' 769 pazjent.
English: The full EPAR for Levetiracetam Actavis 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: Levetiracetam Actavis is a ‘generic medicine'.
Maltese: Levetiracetam Actavis huwa ‘mediċina ġenerika'.
English: In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Maltese: F'pazjenti bejn sitt xhur u 17-il sena li jiżnu inqas minn 50 kg, id-doża tal-bidu għandha tkun 10 mg għal kull kilogramm tal-piż tal-ġisem darbtejn kuljum, li tista' tiżdied sa 30mg/kg darbtejn kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Actavis on 3 October 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Levetiracetam Actavis fit-3 ta' Ottubru 2011.
English: The active substance in Levetiracetam Actavis, levetiracetam, is an anti-epileptic medicine.
Maltese: Is-sustanza attiva f'Levetiracetam Teva, il-levetiracetam, hija mediċina antiepilettika.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Actavis has been shown to have comparable quality and to be bioequivalent to Keppra.
Maltese: Is-CHMP ikkonkluda li, b'konformità mar-rekwiżiti tal-UE, intwera li l-kwalità ta' Levetiracetam Actavis hija kumparabbli u li huwa bijoekwivalenti għal Keppra.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Maltese: Il-mod preċiż ta' kif taħdem il-levetiracetam għadu mhux ċar iżda jidher li din tinterferixxi ma' proteina msejħa proteina sinaptika vexxili 2A, li tinsab flispazji bejn in-nervituri, u hija involuta fir-rilaxx ta' messaġġiera kimiċi miċ-ċelloli tan-nervituri.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Actavis.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Levetiracetam Actavis.
English: What is Levetiracetam Actavis?
Maltese: X'inhu Levetiracetam Actavis?
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Maltese: Din hija tip ta' epilessija fejn ħafna attività elettrika f'naħa waħda tal-moħħ tikkawża sintomi bħal movimenti spażmodiċi għal għarrieda ta' xi parti millġisem, smigħ, xamm, jew viżta mhux ċari, tirżiħ jew sens ta' biża' f'daqqa.
English: Because Levetiracetam Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Maltese: Peress li Levetiracetam Actavis huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet biex jiġi stabbilit jekk din il-mediċina hix bijoekwivalenti għall-mediċina ta' referenza Keppra.
English: When Levetiracetam Actavis is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Maltese: Meta Levetiracetam Actavis jingħata flimkien ma' trattament antiepilettiku ieħor, id-doża tal-bidu f'pazjenti minn 12-il sena 'l fuq li jiżnu aktar minn 50 kg għandha tkun 500 mg darbtejn kuljum.
English: Why has Levetiracetam Actavis been approved?
Maltese: Għaliex ġie approvat Levetiracetam Actavis?
English: Levetiracetam Actavis is a medicine that contains the active substance levetiracetam.
Maltese: Levetiracetam Actavis huwa mediċina li fiha s-sustanza attiva levetiracetam.
English: This means that Levetiracetam Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Maltese: Dan ifisser li Levetiracetam Actavis huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Keppra.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Keppra, il-benefiċċji huma akbar mir-riskji identifikati.
English: Because Levetiracetam Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Levetiracetam Actavis huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: When Levetiracetam Actavis is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Maltese: Id-doża tal-bidu hija 250 mg darbtejn kuljum, u tiżdied ġimgħatejn wara għal 500 mg darbtejn kuljum.
English: This helps Levetiracetam Actavis to stabilise electrical activity in the brain and prevent seizures.
Maltese: Dan jgħin biex Levetiracetam Actavis jistabbilizza l-attività elettrika fil-moħħ u jevita l-aċċessjonijiet.
English: What are the benefits and risks of Levetiracetam Actavis?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Levetiracetam Actavis?
English: How has Levetiracetam Actavis been studied?
Maltese: Kif jaħdem Levetiracetam Actavis?
English: Other information about Levetiracetam Actavis
Maltese: Kif jintuża Levetiracetam Actavis?
English: Parameter n
Maltese: Parametru n
English: It may harm them,
Maltese: Kif taqra is-siringa
English: Step A: Setting up
Maltese: Pass A: Preparazzjoni
English: 1077 ZX Amsterdam The Netherlands
Maltese: 1077 ZX Amsterdam L-Olanda
English: 1077 ZX Amsterdam The Netherlands infogroup@aegerion.com
Maltese: 1077 ZX Amsterdam L-Olanda infogroup@aegerion.com
English: Eurofins PHAST GmbH Kardinal-Wendel-Straße 16 66424 Homburg Germany
Maltese: Eurofins PHAST GmbH Kardinal-Wendel-Straße 16 66424 Homburg Il-Ġermanja
English: Inflamed pancreas (‘pancreatitis'):
Maltese: Frixa infjammata (‘pankreatite'):
English: • 15% reduction in triglycerides (TGs)
Maltese: • tnaqqis ta' 15 % fit-triglycerides (TGs)
English: SD = standard deviation
Maltese: SD = devjazzjoni standard
English: A minimum clinical response is defined as at least:
Maltese: Rispons kliniku minimu huwa definit bħala mill-inqas:
English: Pruritus, Rash, Urticaria
Maltese: Pruritus, Raxx, Urtikarja
English: Aegerion Pharmaceuticals Ltd. Royal Albert House Sheet Street, Windsor SL4 1BE
Maltese: Royal Albert House Sheet Street, Windsor SL4 1BE
English: • The active substance is metreleptin.
Maltese: • Is-sustanza attiva hi metreleptin.
English: Age, Gender, Race, Body Mass Index
Maltese: Età, Sess tal-persuna, Razza, Indiċi tal-Massa tal-Ġisem
English: • muscle pain (‘myalgia')
Maltese: • uġigħ fil-muskoli (‘mijalġija')
English: Date of first authorisation: 30 July 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 30 ta' Lulju 2018
English: • a plastic ampoule
Maltese: • ampulla tal-plastik
English: • Metreleptin is similar to a human hormone called leptin.
Maltese: • Metreleptin huwa simili għal ormon uman imsejjaħ leptin.
English: 1.25 mg (0.25 mL) to 2.5 mg (0.5 mL)
Maltese: 1.25 mg (0.25 mL) sa 2.5 mg (0.5 mL)
English: • statins for reducing cholesterol (such as atorvastatin)
Maltese: • statins għat-tnaqqis tal-kolesterol (bħal atorvastatin)
English: Leptin is a cytokine and has the potential to alter the formation of cytochrome P450 (CYP450) enzymes.
Maltese: Leptin huwa cytokine u għandu l-potenzjal li jibdel il-formazzjoni ta' enzimi ta' ċitokrom P450 (CYP450).
English: • ‘U' means ‘Units'.
Maltese: • ‘U' tfisser ‘Unitajiet'.
English: Arthralgia, Myalgia
Maltese: Artralġja, mijalġija
English: *Metreleptin is a recombinant human leptin analogue (produced in Escherichia coli cells by recombinant DNA technology to form recombinant methionyl-human leptin).
Maltese: *Metreleptin huwa analogu tal-leptin uman rikombinanti (prodott f'ċelluli ta' Escherichia coli permezz ta' teknoloġija rikombinanti tad-DNA sabiex jifforma methionyl-leptin uman rikombinanti).
English: Excipients: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment)
Maltese: TA' EĊĊIPJENTI Eċċipjenti: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (għal aġġustament tal pH)
English: Example:
Maltese: *Nota:
English: Overall, 51 (77%) patients were female, 31 (47%) were Caucasian, 11 (17%) Hispanic, and 16 (24%) Black.
Maltese: B'mod ġenerali, 51 (77%) pazjent kienu nisa, 31 (47%) kienu Kawkasi, 11 (17%) Ispaniċi, u 16 (24%) Suwed.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, amino acids and derivatives, ATC code: A16AA07
Maltese: Prodotti oħra tal-passaġġ alimentari u tal-metaboliżmu, amino acids u derivattivi, Kodiċi ATC:
English: HbA1c ≥ 8%.
Maltese: HbA1c ≥ 6.5% fil-linja bażi.
English: Cough, Dyspnoea Pleural effusion
Maltese: Sogħla, Dispnea, Effużjoni Plewrali
English: In studies of healthy adult subjects, following intravenous administration of metreleptin, leptin volume of distribution (endogenous leptin and metreleptin) was approximately 4 to 5 times plasma volume; volumes (mean ± SD) were 370 ± 184 mL/kg, 398 ± 92 mL/kg, and 463 ± 116 mL/kg for 0.3, 1.0, and 3.0 mg/kg/day doses, respectively.
Maltese: Fi studji dwar individwi adulti b'saħħithom, wara li metreleptin kien ingħata ġol-vini, il-volum ta' distribuzzjoni ta' leptin (leptin endoġenu u metreleptin) kien ta' madwar 4 sa 5 darbiet tal-volum talplażma; volumi (jiġifieri ± SD) kienu ta' 370 ± 184 mL/kg, 398 ± 92 mL/kg, u 463 ± 116 mL/kg għal dożi ta' 0.3, 1.0, u 3.0 mg/kg/kuljum, rispettivament.
English: Total daily volume to be injected is 3.75 mg/5 = 0.75 mL.
Maltese: Volum totali ta' kuljum biex jiġi injettat huwa ta' 3.75 mg/5 = 0.75 mL.
English: > 5.65 mmol/L
Maltese: TG ≥ 5.65 mmol/L u/jew
English: Overall, 30 (97%) patients were female, 26 (84%) were Caucasian, 2 (7%) Hispanic, and 0 Black.
Maltese: B'mod ġenerali, 30 (97%) pazjent kienu nisa, 26 (84%) kienu Kawkasi, 2 (7%) Ispaniċi, u 0 Suwed.
English: The individual patient dose = 1.5 mg
Maltese: Id-doża ta' pazjent individwali = 1.5 mg
English: The median fasting leptin concentration at baseline was 5.9 ng/mL (1.6-16.9) using the LINCO RIA test method.
Maltese: Il konċentrazzjoni medjana ta' leptin fl-istat sajjem fil-linja bażi kienet ta' 5.9 ng/mL (1.6-16.9) bl-użu tal-metodu tat-test LINCO RIA.
English: Frequencies are defined as 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 available data).
Maltese: Il-frekwenzi huma definiti bħala 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 magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Sodium Hydroxide (for pH adjustment)
Maltese: Sodium Hydroxide (għal aġġustament tal-pH)
English: Fasting Triglycerides (mmol/L) 27
Maltese: Triglycerides fl-istat sajjem (mmol/L)
English: In 43 patients with hepatic data available, the mean changes at Month 12 in alanine aminotransferase, versus baseline (112.5 U/L) was -53.1 U/L, and aspartate aminotransferase versus baseline (75.3 U/L) was -23.8 U/L.
Maltese: Fi 43 pazjent b'dejta epatika disponibbli, il-bidliet medji f'Xahar 12 f'alanine aminotransferase, kontra llinja bażi (112.5 U/L) kienu ta' -53.1 U/L, u f'aspartate aminotransferase kontra l-linja bażi (75.
English: For instructions on administration, see section 4.2.
Maltese: Għal istruzzjonijiet fuq kif għandu jingħata, ara sezzjoni 4.2 .
English: • medicines which suppress the immune system (such as cyclosporine)
Maltese: • mediċini li jrażżnu s-sistema immuni (bħal cyclosporine)
English: • weight gain
Maltese: • influwenza
English: • blood pressure medicines called ‘calcium channel blockers'
Maltese: • mediċini għall-pressjoni tad-demm imsejħa ‘imblokkaturi tal-kanali tal-kalċju'
English: • blood-thinning medicines (such as warfarin or phenprocoumon)
Maltese: • mediċini li jraqqu d-demm (bħal warfarin jew phenprocoumon)
English: Frequency not known*
Maltese: Frekwenza mhux magħrufa*
English: • medicines for sleep or anxiety called ‘benzodiazepines'
Maltese: • mediċini għall-irqad jew ansjetà msejħa ‘benzodiazepines'
English: ● Fasting insulin concentration > 30 μU/mL, or
Maltese: ● Konċentrazzjoni tal-insulina fl-istat sajjem ta' > 30 μU/mL, jew
English: The median fasting leptin concentration at baseline was 1.0 ng/mL in males (range: 0.3-3.3 ng/mL) and 1.1 ng/mL in females (range: 0.2-5.3 ng/mL) using the LINCO RIA test method.
Maltese: Il-konċentrazzjoni medjana ta' leptin fl-istat sajjem fil-linja bażi kienet ta' 1.0 ng/mL fl-irġiel (medda: 0.3-3.3 ng/mL) u 1.1 ng/mL fin-nisa (medda: 0.2-5.3 ng/mL) bl-użu tal-metodu tat-test LINCO RIA.
English: The plastic ampoule is a sealed container with a twist-off top.
Maltese: L-ampulla tal-plastik hija kontenitur issiġillat b'għatu twist-off.
English: o Hypersensitivity has been reported with Myalepta use including anaphylaxis, urticaria and generalised rash.
Maltese: o Ġiet irrappurtata sensittività eċċessiva bl-użu ta' Myalepta inkluż anafilassi, urtikarja u raxx ġeneralizzat.
English: Myalepta might increase fertility in women with lipodystrophy (see section “Pregnancy, breast-feeding and fertility”).
Maltese: Myalepta jista' jżid il-fertilità f'nisa b'lipodistrofija (ara sezzjoni “Tqala, treddigħ u fertilità”).
English: Myalepta is available in packs containing 1 or 30 vials.
Maltese: Myalepta hu disponibbli f'pakketti li fihom 1 jew 30 kunjett.
English: In 24 patients with renal data available, the mean change at Month 12 in protein excretion rate versus baseline (1,675.7 mg/24hr) was -906.1 mg/24 hr.
Maltese: F'24 pazjent b'dejta renali disponibbli, il-bidla medja f'Xahar 12 fir-rata taleliminazzjoni tal-proteina kontra l-linja bażi (1,675.7 mg/24 siegħa) kienet ta' -906.1 mg/24 siegħa.
English: In clinical trials, antidrug antibodies (ADA) to metreleptin occurred very commonly (88%) in patients.
Maltese: Fil-provi kliniċi, antikorpi kontra l-mediċina (ADA, antidrug antibodies) għal metreleptin seħħew b'mod komuni ħafna (88%) f'pazjenti.
English: Table 1 Metreleptin recommended dose Baseline weight
Maltese: Tabella 1 Doża rakkomandata ta' metreleptin
English: There might be local regulations for this.
Maltese: Jista' jkun hemm regolamenti lokali dwar dan.
English: Among 18 patients in the partial LD subgroup who had a baseline HbA1c level 8% or greater and data available at Month 12, the mean (SD) baseline HbA1c level was 9.9% (1.59) and the mean reduction in HbA1c at Month 12 was 1.3%.
Maltese: Fost 18-il pazjent fis-sottogrupp ta' LD parzjali li kellhom HbA1c fil-linja bażi ta' 8% jew aktar, u dejta disponibbli f'Xahar 12, il-medja (SD) ta' HbA1c fil-linja bażi kienet ta' 9.9% (1.59), u t-tnaqqis medju f'HbA1c f'Xahar 12 kien ta' 1.3%.
English: • 1 U is the same as 0.01 mL.
Maltese: • 1 U hija l-istess bħal 0.01 mL.
English: A dose increment of 1.25 mg increases the daily dose to 3.75 mg.
Maltese: Żieda fiddoża ta' 1.25 mg iżżid id-doża ta' kuljum għal 3.75 mg.
English: • The other ingredients are: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment).
Maltese: • Is-sustanzi mhux attivi l-oħra huma: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (għal aġġustament tal-pH).
English: The median duration of metreleptin treatment was 4.2 years (range: 3.4 months-13.8 years).
Maltese: It-tul medju tat-trattament b'metreleptin kien ta' 4.2 sena (medda: 3.4 xhur-13.8 snin).
English: Pack sizes of 1 or 30 vials.
Maltese: Daqsijiet tal-pakkett ta' 1 jew 30 kunjett.
English: A total of 148 patients with generalised and partial LD received metreleptin during clinical studies.
Maltese: Total ta' 148 pazjent b'LD ġeneralizzata u parzjali rċivew metreleptin matul l-istudji kliniċi.
English: See section 3 “How much to inject” for more information.
Maltese: Ara sezzjoni 3 “Kemm għandek tinjetta” għal aktar informazzjoni.
English: Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation (see section 4.4).
Maltese: Sinjali u/jew sindromi konsistenti ma' pankreatite għandhom iwasslu għal evalwazzjoni klinika xierqa (ara sezzjoni 4.4).
English: The Applicant should conduct this integrated analysis according to an agreed protocol including samples from all available historical samples from previous studies (NIH991265/20010769, FHA 101, NASH4 and obesity studies) with patients with GL/PL and samples obtained from patients that will be included in the efficacy and safety study in PL patients, the paediatric investigational plan (PIP) study and the patients registry.
Maltese: L-Applikant għandu jwettaq din l-analiżi integrata skont protokoll miftiehem inklużi kampjuni mill-kampjuni storiċi disponibbli kollha minn studji preċedenti (NIH991265/20010769, FHA 101, NASH4 u studji dwar l-obeżità) b'pazjenti b'GL/PL, u kampjuni meħuda minn pazjenti li se jiġu inklużi fl-istudju dwar l-effikaċja u s sigurtà f'pazjenti b'PL, l-istudju tal-pjan ta' investigazzjoni pedjatrika (PIP, paediatric investigational plan) u r-reġistru talpazjenti.
English: syringe to inject
Maltese: Infezzjonijiet u infestazzjonijiet
English: Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:
Maltese: Myalepta huwa indikat bħala żieda mad-dieta bħala terapija ta' sostituzzjoni biex jittratta lkumplikazzjonijiet tad-defiċjenza ta' leptin f'pazjenti b'lipodistrofija (LD):
English: Throw it away and start again from step 1.
Maltese: Jekk ikun fiha, armiha u erġa' ibda minn pass 1.
English: - Lymphoproliferative disorders, including lymphoma have been reported in patients with acquired generalised LD not treated with Myalepta.
Maltese: - Disturbi limfoproliferattivi, inklużi limfomi, ġew irrappurtati f'pazjenti b'LD akkwiżita ġeneralizzata li ma tkunx ittrattata b'Myalepta.
English: A total of 8 (24%) of the 34 patients with generalised LD who were receiving lipid-lowering therapies at baseline discontinued their use during metreleptin treatment.
Maltese: Total ta' 8 (24%) mill-34 pazjent b'LD ġeneralizzata li kienu qed jirċievu terapiji li jbaxxu l-lipids fil-linja bażi waqqfu l-użu tagħhom waqt it-trattament b'metreleptin.
English: Myalepta 11.3 mg powder for solution for injection Type I glass vial (5 mL) with a bromobutyl rubber stopper and an aluminium seal/white plastic flip-off cap.
Maltese: Myalepta 11.3 mg trab għal soluzzjoni għall-injezzjoni Kunjett tal-ħġieġ (5 mL) tat-tip I b'tapp tal-lastku bromobutyl u siġill tal-aluminju/għatu flip-off tal plastik abjad.
English: Of the 66 generalised LD patients enrolled, 45 (68%) had congenital generalised LD and 21 (32%) had acquired generalised LD.
Maltese: Mis-66 pazjent b'LD ġeneralizzata rreġistrati, 45 (68%) kellhom LD ġeneralizzata konġenitali u 21 (32%) kellhom LD ġeneralizzata akkwiżita.
English: 31 gauge 8 mm needle
Maltese: Daqs ta' 31 Labra ta' 8 mm
English: Step F: Injecting Myalepta
Maltese: Pass F: Kif tinjetta Myalepta
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3 .
English: • feeling more irritable or more nervous
Maltese: • tħossok aktar irritabbli jew aktar nervuż
English: Table 7 Adverse reactions reported with Myalepta in > 1 patient during clinical studies in generalised LD and the subgroup of partial LD patients and post-marketing experience System Organ Class
Maltese: Tabella 7 Reazzjonijiet avversi rrappurtati b'Myalepta f'> 1 pazjent matul studji kliniċi fissottogrupp ta' pazjenti b'LD ġeneralizzata u s-sottogrupp ta' LD parzjali u l-esperjenza ta' wara t-tqegħid fis-suq
English: • Women who could get pregnant should use effective contraception, including non-hormonal methods such as condoms, while using Myalepta.
Maltese: • Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċezzjoni effettiva, li jinkludu metodi mhux ormonali bħal kondoms, waqt li jużaw Myalepta.
English: Cases of T-cell lymphoma (see section 4.8) have been reported while using Myalepta in clinical studies.
Maltese: Każijiet ta' limfoma taċ-ċelluli T (ara sezzjoni 4.8) ġew irrappurtati waqt l-użu ta' Myalepta fl-istudji kliniċi.
English: Injection site reactions were reported in 3.4% of patients with LD treated with metreleptin.
Maltese: Reazzjonijiet fis-sit tal-injezzjoni ġew irrappurtati fi 3.4% tal-pazjenti b'LD ittrattata b'metreleptin.
English: Table 8 Primary outcome results in an open-label, single-arm study (NIH 991265/20010769) in evaluable patients with generalised LD treated with metreleptin at 12 months Parameter n
Maltese: Tabella 8 Riżultati primarji fi studju open-label u single-arm (NIH 991265/20010769) f'pazjenti b'LD ġeneralizzata li setgħu jiġu evalwati, ittrattati b'metreleptin wara 12-il xahar
English: Weight (kg) x 0.02 mg/kg = amount of dose adjustment in mg
Maltese: Piż (kg) x 0.02 mg/kg = ammont tal-aġġustament tad-doża f'mg
English: The effect of metreleptin on CYP450 enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted.
Maltese: L-effett ta' metreleptin fuq enzimi ta' CYP450 jista' jkun klinikament rilevanti għas-substrati ta' CYP450 b'indiċi terapewtiku dejjaq, fejn id-doża tiġi aġġustata individwalment.
English: • Each vial contains 3 milligrams of metreleptin.
Maltese: • Kull kunjett fih 3 milligrammi ta' metreleptin.
English: - The benefits and risks of Myalepta should be carefully considered in patients with acquired LD and/or those with significant haematologic abnormalities (including leukopenia, neutropenia, bone marrow abnormalities, lymphoma and/or lymphadenopathy).
Maltese: - Il-benefiċċji u r-riskji ta' Myalepta għandhom jiġu kkunsidrati bir-reqqa f'pazjenti b'LD akkwiżita u/jew f'pazjenti b'anormalitajiet ematoloġiċi sinifikanti (inklużi lewkopenija, newtropenija, anormalitajiet fil-mudullun, limfoma, u/jew limfadenopatija).
English: 30 gauge 13 mm needle
Maltese: Daqs ta' 30 Labra ta' 13 mm
English: 5) Withdraw 2.2 mL of water for injection into the 3 mL syringe.
Maltese: 5) Iġbed 2.2 mL ta' ilma għall-injezzjoni fis-siringa ta' 3 mL.
English: Discontinuation in patients at risk for pancreatitis
Maltese: Waqfien f'pazjenti f'riskju għal pankreatite
English: Acute pancreatitis associated with discontinuation of metreleptin In clinical studies, 6 patients (4 with generalised LD and 2 with partial LD), experienced treatment-emergent pancreatitis.
Maltese: Pankreatite akuta assoċjata mat-twaqqif ta' metreleptin Fl-istudji kliniċi, 6 pazjenti (4 b'LD ġeneralizzata u 2 b'LD parzjali), kellhom pankreatite li żviluppat bit-trattament.