FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.264 mL 0.26 mL
Maltese: 0.264 mL
English: • Keep this leaflet.
Maltese: • Iċċaqlaqx il-planġer.
English: Myalepta is presented as a powder for solution for injection (powder for injection).
Maltese: Myalepta hu ppreżentat bħala trab għal soluzzjoni għall-injezzjoni (powder for injection).
English: Each vial contains 3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL)
Maltese: Kull kunjett fih 3 mg ta' metreleptin Wara r-rikostituzzjoni, kull mL ikun fih 5 mg ta' metreleptin (5 mg/mL)
English: 0.132 mL 0.13 mL
Maltese: 0.132 mL
English: Fat tissue increased, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site swelling, Malaise, Peripheral swelling
Maltese: Żieda fit-triglycerides fid-demm, Antikorp speċifiku għallmediċina preżenti, Żieda fi glycosylated emoglobina, Żieda fil-piż
English: After reconstitution with 2.2 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Maltese: Wara r-rikostituzzjoni b'2.2 mL ta' ilma għall-injezzjonijiet (ara sezzjoni 6.6), kull mL ikun fih 5 mg ta' metreleptin.
English: • Healthcare professionals training material
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Headache
Maltese: Azzjoni
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
Maltese: Eċċipjenti Din il-mediċina fiha anqas minn 1 mmol todium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Needle gauge and length Myalepta dose range to be administered
Maltese: Kif jidher Myalepta u l-kontenut tal-pakkett
English: Using the 1 mL syringe
Maltese: injezzjoni ta' 2 mL
English: • Pull up until the top rim of the plunger lines up with the black 1.1 mL line.
Maltese: • Iġbdu 'l isfel sakemm ix-xifer ta' fuq tal-planġer ikun bi dritt mal-linja sewda ta' 1.1 mL.
English: • headache
Maltese: • dijabete
English: Important: Myalepta must be injected under the skin (‘subcutaneous').
Maltese: Myalepta jrid jiġi injettat taħt il-ġilda (injezzjoni ‘subkutanea').
English: - Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation.
Maltese: - Sinjali u/jew sindromi konsistenti ma' pankreatite għandhom iwasslu għal evalwazzjoni klinika xierqa.
English: Generalised LD
Maltese: Pass G:
English: The reconstituted solution will take less than 5 minutes to become clear.
Maltese: Is-soluzzjoni rikostitwita se tieħu inqas minn 5 minuti biex issir ċara.
English: Using the 0.3 mL syringe
Maltese: L-użu tas-siringa ta' 0.3 mL
English: The weighted average daily dose (i.e., the average dose taking into account duration of treatment at different doses) for the 48 patients with baseline body weight greater than 40 kg was 2.6 mg for males and 5.2 mg for females during the first year of treatment, and 3.7 mg for males and 6.5 mg for females over the entire study period.
Maltese: Id-doża medja ta' kuljum ippiżata (weighted) (i.e., id-doża medja jekk wieħed jikkunsidra t-tul tat-trattament b'dożi differenti) għal 48 pazjent b'piż tal-ġisem fil-linja bażi ta' aktar minn 40 kg, kienet ta' 2.6 mg għall-irġiel u ta' 5.2 mg għan-nisa matul l-ewwel sena tat-trattament, u 3.7 mg għall-irġiel u ta' 6.5 mg għan-nisa waqt il-perjodu kollu tal-istudju.
English: • blood clot in your veins (deep vein thrombosis) - pain, swelling, warmth & redness, usually occurring in lower leg or thigh
Maltese: • embolu tad-demm fil-vini tiegħek (trombożi fil-vini profondi) - uġigħ, nefħa, sħana u ħmura, li ġeneralment iseħħu fil-parti t'isfel tar-riġel jew fil-koxxa
English: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/red plastic flip-off cap.
Maltese: Kunjett tal-ħġieġ (3 mL) tat-tip I b'tapp tal-lastku chlorobutyl u siġill tal-aluminju/għatu flip-off tal plastik aħmar.
English: After reconstitution with 1.1 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Maltese: Wara r-rikostituzzjoni b'1.1 mL ta' ilma għall-injezzjonijiet (ara sezzjoni 6.6), kull mL ikun fih 5 mg ta' metreleptin.
English: 9) With 2.2 mL of water for injection in the syringe, remove the syringe from the vial or ampoule.
Maltese: 9) B'2.2 mL ta' ilma għall-injezzjoni fis-siringa, neħħi s-siringa mill-kunjett jew l-ampulla.
English: 0.240 mL 0.24 mL
Maltese: 0.240 mL
English: • stomach pain, feeling sick (nausea) and being sick (vomiting)
Maltese: • uġigħ fl-istonku, tħossok imdardar (nawseja) u tirremetti (taqla')
English: Step D: Filling the syringe with Myalepta for injection
Maltese: Pass D: Kif timla s-siringa b'Myalepta għall-injezzjoni
English: Across two completed clinical studies (NIH 991265/20010769 and FHA101), there were 52 paediatric patients (4 in the subgroup of partial LD patients and 48 with generalised LD) enrolled and exposed to metreleptin.
Maltese: F'żewġ studji kliniċi kompluti (NIH 991265/20010769 u FHA101), kien hemm 52 pazjent pedjatriku
English: Among 24 patients with generalised LD who had a baseline TG level 5.65 mmol/l or greater and data available at Month 12, the mean (SD) baseline TG level was 31.7 mmol/l (33.68) and the mean percent reduction in triglycerides at Month 12 was 72%.
Maltese: 5.65 mmol/L jew aktar, u dejta disponibbli f'Xahar 12, il-medja (SD) tal-livell ta' TG fil-linja bażi kienet ta' 31.7 mmol/L (33.68), u t-tnaqqis perċentwali medju fit-triglycerides f'Xahar 12 kien ta'
English: Metabolism and nutrition disorders Hypoglycaemia Decreased appetite Diabetes mellitus, Hyperphagia, Insulin resistance
Maltese: Dijabete mellitus, Hyperphagia,
English: • Pull up until the top rim of the plunger lines up with the black 0.6 mL line.
Maltese: • Iġbdu 'l isfel sakemm ix-xifer ta' fuq tal-planġer ikun bi dritt mal-linja sewda ta' 0.6 mL.
English: • If there is less than 2.2 mL of water for injection in the syringe, draw more water for injection into the syringe and repeat the steps 6 and 7 until you have 2.2 mL in the syringe.
Maltese: • Jekk hemm inqas minn 2.2 mL ta' ilma għall-injezzjoni fis-siringa, tiġbed aktar ilma għall injezzjoni ġos-siringa u rrepeti l-passi 6 u 7 sakemm ikollok 2.2 mL fis-siringa.
English: For doses of: > 1.5 mg - 5 mg / 0.3 - 1.0 mL volume daily
Maltese: Volum ta' kuljum ta' > 1.5 mg - 5 mg/0.
English: However, separate studies revealed that exposure of the mouse foetus to metreleptin was low (< 1%) after subcutaneous administration of metreleptin to pregnant mice.
Maltese: Madankollu, studji separati wrew li l-esponiment tal-fetu tal-ġurdien għal metreleptin kien baxx (< 1%) wara l-għoti taħt il-ġilda ta' metreleptin lil ġrieden tqal.
English: Plastic ampoule of water for injection
Maltese: Ampulla tal-plastik tal-ilma għall-injezzjoni
English: • increased fat in the blood (‘triglycerides')
Maltese: • żieda fix-xaħam fid-demm (‘triglycerides')
English: 0.216 mL 0.21 mL
Maltese: 0.216 mL
English: A blocking activity of the reaction between metreleptin and a recombinant leptin receptor has been observed in vitro in the blood of the majority of an extended set of patients (98 out of 102 patients or 96%) but the impact on the efficacy of metreleptin could not be clearly established.
Maltese: Attività ta' imblukkar tar-reazzjoni bejn metreleptin u riċettur ta' leptin rikombinanti ġiet osservata in vitro fiddemm tal-maġġoranza ta' sett estiż ta' pazjenti (98 minn 102 pazjent jew 96%), iżda l-impatt fuq leffikaċja ta' metreleptin ma setax jiġi stabbilit b'mod ċar.
English: After dissolving the vial contents in 0.6 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Maltese: f'0.6 millilitri ta' ilma għall-injezzjonijiet, kull millilitru jkun fih 5 milligrammi ta' metreleptin.
English: In clinical trials (Studies NIH 991265/20010769 and FHA101), the rate of ADAs for generalised LD and the partial LD patients studied and with data available were 88% (65 out of 74 patients).
Maltese: ġeneralizzata u LD parzjali studjati, u bid-dejta disponibbli, kienet 88% (65 minn 74 pazjent).
English: There is a risk of hypoglycaemia in patients treated with Myalepta who are on anti-diabetic medicinal products, in particular insulin or insulin secretagogues (e.g. sulphonylureas).
Maltese: Ipogliċemija bl-użu fl-istess ħin mal-insulina u antidijabetiċi oħra Hemm riskju ta' ipogliċemija f'pazjenti ttrattati b'Myalepta li jkunu qegħdin fuq prodotti mediċinali kontra d-dijabete, b'mod partikulari insulina jew secretagogues tal-insulina (eż. sulphonylureas).
English: Reproductive toxicity studies conducted in mice have revealed no adverse effects on mating, fertility or embryo-foetal development up to the maximum tested dose, approximately, 15-fold the maximum recommended clinical dose, based on body surface area of a 60 kg patient.
Maltese: Studji ta' tossiċità tar-riproduzzjoni li saru fuq il-ġrieden ma żvelaw l-ebda effetti avversi fuq it tgħammir, fertilità jew żvilupp embrijo-fetali sad-doża massima ttestjata, bejn wieħed u ieħor, 15-il darba aktar id-doża massima klinika rakkomandata, ibbażata fuq l-erja tas-superfiċje tal-ġisem ta' pazjent ta' 60 kg.
English: In clinical studies, hypoglycaemia has been managed with food/drink intake and by modifying the dose of anti-diabetic medicinal product.
Maltese: Fi studji kliniċi, l-ipogliċemija ġiet immaniġġjata bil-konsum tal-ikel/xorb u billi tinbidel id-doża talprodott mediċinali kontra d-dijabete.
English: 0.3 mL U100 Insulin Syringe
Maltese: Siringa tal-Insulina ta' U100 0.3 mL
English: Pharmacokinetics in special populations
Maltese: Aegerion Pharmaceuticals
English: Limited clinical data exists in children less than 2 years old for generalised LD patients and less than 12 years old in partial LD patients.
Maltese: Teżisti dejta klinika limitata fi tfal iżgħar minn sentejn għal pazjenti b'LD ġeneralizzata u iżgħar minn 12-il sena f'pazjenti b'LD parzjali.
English: • The solution will take less than 5 minutes to become clear.
Maltese: • Is-soluzzjoni se tieħu inqas minn 5 minuti biex issir ċara.
English: − A starting dose is 2.5 mg (0.5 mL of solution).
Maltese: − Id-doża tal-bidu hija ta' 2.5 mg (0.5 mL ta' soluzzjoni).
English: o Hypoglycaemia with concomitant use of insulin and other antidiabetics may occur:
Maltese: Effetti sekondarji possibbli b'din il-mediċina:
English: Among the 4 patients in the partial LD subgroup between 12 and 18 years of age, mean change to Month 12/LOCF for HbA1c was -0.7% and for TGs was -55.1%.
Maltese: Fost l-erba' pazjenti fis-sottogrupp ta' LD parzjali li kellhom bejn 12-il u 18-il sena, il-bidla medja għal Xahar 12/LOCF għal HbA1c kienet ta' -0.7% u għal TGs kienet ta' -55.1%.
English: After reconstitution with 0.6 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Maltese: Wara r-rikostituzzjoni b'0.6 mL ta' ilma għall-injezzjonijiet (ara sezzjoni 6.6), kull mL ikun fih 5 mg ta' metreleptin.
English: 9) With 1.1 mL of water for injection in the syringe, remove the syringe from the vial or ampoule.
Maltese: 9) B'1.1 mL ta' ilma għall-injezzjoni fis-siringa, neħħi s-siringa mill-kunjett jew l-ampulla.
English: Due to the number of patients with generalised and partial LD treated in clinical trials, it is not possible to detect with certainty, events which occur at a frequency of < 1%.
Maltese: Minħabba n-numru ta' pazjenti b'LD ġeneralizzata u parzjali ttrattati fi provi kliniċi, mhuwiex possibbli li jiġu osservati b'ċertezza, episodji li jseħħu bi frekwenza ta' < 1%.
English: 9) With 0.6 mL of water for injection in the syringe, remove the syringe from the vial or ampoule.
Maltese: 9) B'0.6 mL ta' ilma għall-injezzjoni fis-siringa, neħħi s-siringa mill-kunjett jew l-ampulla.
English: 0.13 mg/kg (0.026 mL/kg)
Maltese: 0.13 mg/kg (0.
English: The adverse reactions reported in generalised LD and this subgroup of partial LD patients are listed in Table 7.
Maltese: Ir-reazzjonijiet avversi rrappurtati fil-pazjenti tas-sottogrupp ta' LD ġeneralizzata u f'dan is-sottogrupp ta' LD parzjali huma elenkati f'Tabella 7.
English: 25 kg patient is initiated at 0.012 mL/kg = 0.3 mL of Myalepta solution to inject
Maltese: 012 mL/kg = 0.3 mL ta' soluzzjoni ta'
English: 0.120 mL 0.12 mL
Maltese: 0.120 mL
English: Among the 39 patients with generalised LD who were receiving insulin at baseline, 16 (41%) were able to discontinue insulin use altogether after starting metreleptin.
Maltese: Fost id-39 pazjent b'LD ġeneralizzata li kienu qed jirċievu l-insulina fil-linja bażi, 16 (41%) kienu kapaċi jwaqqfu l-użu tal-insulina għalkollox wara li bdew metreleptin.
English: • One 1 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder
Maltese: • Siringa waħda ta' 1 mL b'labra ta' daqs ta' 21 u ta' 40 mm biex tħoll it-trab
English: - Rotation of injection sites is recommended in patients co administering insulin (or other SC medicinal products) and Myalepta.
Maltese: - Huwa rrakkomandat tibdil fil-post tal-injezzjoni f'pazjenti li jkunu qed jieħdu linsulina (jew prodotti mediċinali oħra taħt il-ġilda) u Myalepta fl-istess ħin.
English: Myalepta 5.8 mg powder for solution for injection.
Maltese: Myalepta 5.8 mg trab għal soluzzjoni għall-injezzjoni.
English: Influenza, Pneumonia
Maltese: Influwenza, Pnewmonja
English: Attach the needle to the syringe.
Maltese: Dejjem uża siringa ġdida.
English: • Use the alcohol swab to clean the break point on the ampoule.
Maltese: • Uża t-tajjara bl-alkoħol biex tnaddaf il-break-point fuq l-ampulla.
English: Sucrose
Maltese: Siringa
English: o If your dose is more than 1.5 mg up to 5 mg, you will use a 1 mL syringe.
Maltese: o Jekk id-doża tiegħek hija ta' 1.5 mg sa 5 mg, se jkollok bżonn tuża siringa ta' 1 mL.
English: Using the 2.5 mL syringe
Maltese: Kif tuża s-siringa ta' 2.5 mL
English: ● Presence of diabetes mellitus, or
Maltese: ● Preżenza ta' dijabete mellitus, jew
English: Myalepta 3 mg powder for solution for injection Using a 1 mL syringe with a 21-gauge or smaller diameter needle, withdraw 0.6 mL of water for injection.
Maltese: Myalepta 3 mg trab għal soluzzjoni għall-injezzjoni Permezz tal-użu ta' siringa ta' 1 mL b'daqs ta' 21 jew dijametru tal-labra iżgħar, wieħed għandu jneħħi 0.6 mL ta' ilma għall-injezzjoni.
English: All patients had a history of pancreatitis and hypertriglyceridaemia.
Maltese: Il-pazjenti kollha kellhom storja medika ta' pankreatite u ipertrigliċeridemija.
English: Myalepta 11.3 mg powder for solution for injection.
Maltese: Myalepta 11.3 mg trab għal soluzzjoni għall-injezzjoni.
English: Since it cannot be excluded that metreleptin may reduce exposure to substrates of CYP3A through enzyme induction, the efficacy of hormonal contraceptives may be reduced if co-administered with metreleptin.
Maltese: o Jista' jkun hemm telf ta' effikaċja f'pazjenti fuq terapija b'Myalepta, potenzjalment minħabba antikorpi newtralizzanti.
English: For females > 40 kg once daily dose
Maltese: Għall-irġiel ta' > 40 kg doża ta' darba kuljum
English: There have been reports of generalised hypersensitivity (e.g. anaphylaxis, urticaria or generalised rash) in patients using Myalepta.
Maltese: Kien hemm rapporti ta' sensittività eċċessiva ġeneralizzata (eż. anafilassi, urtikarja jew raxx ġeneralizzat) f'pazjenti li jużaw Myalepta.
English: There was evidence of improvement in renal and hepatic function in patients with generalised LD treated with metreleptin.
Maltese: Kien hemm evidenza ta' titjib fil-funzjoni epatika u renali f'pazjenti b'LD ġeneralizzata ttrattati b'metreleptin.
English: 0.228 mL 0.22 mL
Maltese: 0.228 mL
English: Glycine
Maltese: Anzjani
English: In generalised LD patients, the overall incidence of adverse reactions was similar regardless of age.
Maltese: F'pazjenti b'LD ġeneralizzata, l-inċidenza globali ta' reazzjonijiet avversi kienet simili irrispettivament mill-età.
English: Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation.
Maltese: Sinjali u/jew sindromi konsistenti ma' pankreatite għandhom iwasslu għal evalwazzjoni klinika xierqa.
English: For males > 40 kg once daily dose
Maltese: Għan-nisa ta' > 40 kg doża ta' darba kuljum
English: Instructions for Use Before using Myalepta, you must first read Sections 1 - 6 of this package leaflet, and then read Section 7 Instructions for Use.
Maltese: Qabel ma tuża Myalepta, l-ewwel għandek taqra s-Sezzjonijiet 1 - 6 ta' dan il-fuljett ta' tagħrif, u mbagħad aqra s-Sezzjoni 7 Istruzzjonijiet għall-Użu.
English: Amount of mixed Myalepta solution to inject in ‘Unit' measurements on your 0.3 mL syringe
Maltese: Myalepta biex tinjetta f'kejl ta' ‘Unità' fuq is-siringa ta' 0.3 mL
English: ● thigh
Maltese: • inti tqila
English: Attach the needle to the 3 mL syringe.
Maltese: Waħħal il-labra mas-siringa ta' 3 mL.
English: • One 3 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder
Maltese: • Siringa waħda ta' 3 mL b'labra ta' daqs ta' 21 u ta' 40 mm biex tħoll it-trab
English: • The 0.3 mL syringe shows the injection amount in ‘U' instead of ‘mL'.
Maltese: • Is-siringa ta' 0.3mL turi l-ammont ta' injezzjoni f'‘U' minflok ‘mL'.
English: • If there is less than 0.6 mL of water for injection in the syringe, draw more water for injection into the syringe and repeat the steps 6 and 7 until you have 0.6 mL in the syringe.
Maltese: • Jekk hemm inqas minn 0.6 mL ta' ilma għall-injezzjoni fis-siringa, tiġbed aktar ilma għall injezzjoni ġos-siringa u rrepeti l-passi 6 u 7 sakemm ikollok 0.6 mL fis-siringa.
English: • The patient information leaflet
Maltese: • żieda fil-piż
English: • Each 0.1 mL is shown as a number with a big line.
Maltese: • Kull 0.1 mL jidher bħala linja iżgħar.
English: In order to address the potential safety concerns and/or lack of efficacy related to immunogenicity of Myalepta, the applicant should submit an integrated analysis of immunogenicity measured according to validated assays.
Maltese: Sabiex jiġu indirizzati l-problemi potenzjali dwar is-sigurtà u/jew in-nuqqas ta' effikaċja relatata mal-immunoġeniċità ta' Myalepta, l-applikant għandu jissottometti analiżi integrata talimmunoġeniċità mkejla skont assaġġi validati.
English: Myalepta 11.3 mg powder for solution for injection metreleptin
Maltese: Myalepta 11.3 mg trab għal soluzzjoni għall-injezzjoni metreleptin
English: • stomach area (abdomen), except for a 5 cm area directly around the belly button
Maltese: • fiż-żona tal-istonku (żaqq), ħlief għal żona ta' 5 cm direttament madwar iż-żokra
English: Glutamic acid
Maltese: Glycine Sucrose Polysorbate 20 Glutamic acid
English: • cough
Maltese: Kundl
English: This is the same as 0.005 mL.
Maltese: Din hija l-istess bħal 0.005 mL.
English: For the 32 patients with generalised LD who were receiving oral anti-diabetic medicinal products at baseline, 7 (22%) were able to discontinue their use.
Maltese: Għat32 pazjent b'LD ġeneralizzata li kienu qed jirċievu prodotti mediċinali orali għal kontra d-dijabete fillinja bażi, 7 (22%) kienu kapaċi jwaqqfu l-użu tagħhom.
English: 2) Before preparing Myalepta solution, allow the powder vial to reach room temperature for about 10 minutes.
Maltese: 2) Qabel ma tipprepara s-soluzzjoni ta' Myalepta, ħalli l-kunjett bit-trab jilħaq it-temperatura tal kamra għal madwar 10 minuti.
English: Animal studies showed no adverse effects on male or female fertility (see section 5.3).
Maltese: Studji fuq l-annimali ma wrew l-ebda effetti avversi fuq il-fertilità (ara sezzjoni 5.3).
English: 16) To inject the Myalepta solution, you will use a new injection syringe, which will either be the 0.3 mL, 1.0 mL, or 2.5 mL syringe that was provided to you by your doctor, nurse or pharmacist.
Maltese: 16) Biex tinjetta s-soluzzjoni ta' Myalepta, inti se tuża siringa ġdida għall-injezzjoni, li se tkun jew is siringa ta' 0.3 mL, 1.0 mL jew 2.5 mL li tkun ġiet ipprovduta lilek mit-tabib, mill-infermier jew mill ispiżjar tiegħek.
English: Very limited data are available for children, especially less than 6 years, with generalised LD.
Maltese: Hemm data limitata ħafna disponibbli għat-tfal, speċjalment ta' inqas minn 6 snin, b'LD ġeneralizzata.
English: An association between the development of Neutralising Antibodies (NAbs) and serious and severe infections cannot be excluded and the continuation of Myalepta should be at the discretion of the prescriber.
Maltese: Newtralizzanti (NAbs) u infezzjonijiet serji u severi, u l-kontinwazzjoni ta' Myalepta għandha tkun fid-diskrezzjoni ta' min jippreskrivih.
English: A separate case of anaplastic large cell lymphoma was reported in a paediatric patient receiving the medicinal product who did not have haematological abnormalities before treatment.
Maltese: It-tnejn kellhom immunodefiċjenza u anormalitajiet ematoloġiċi sinifikanti li jinkludu anormalitajiet talmudullun severi qabel ma nbeda t-trattament.
English: Non-compliance with, or abrupt discontinuation of, Myalepta may result in worsening hypertriglyceridaemia and associated pancreatitis, particularly in patients with risk factors for pancreatitis (e.g. history of pancreatitis, severe hypertriglyceridaemia) (see section 4.8).
Maltese: Akkumulazzjoni aktar għolja ġiet osservata b'livelli ogħla ta' ADA. Aġġustamenti fid-doża għandhom isiru abbażi ta' rispons kliniku (ara sezzjoni 4.4).
English: • who have partial lipodystrophy which is inherited (also called congenital or familial lipodystrophy)
Maltese: • li jkollhom lipodistrofija parzjali li tintiret (imsejħa wkoll lipodistrofija konġenitali jew familjali)
English: Peak serum leptin (endogenous leptin and metreleptin) concentration (Cmax) occurred approximately 4.0 hours after subcutaneous administration of single doses ranging from 0.1 to 0.3 mg/kg in healthy adult subjects.
Maltese: L-ogħla konċentrazzjoni (Cmax) fis-serum tal-leptin (leptin endoġenu u metreleptin) seħħet bejn wieħed u ieħor 4.0 sigħat wara l-għoti taħt il-ġilda ta' dożi waħidhom li kienu jvarjaw minn 0.1 sa 0.3 mg/kg f'individwi adulti b'saħħithom.
English: Example: A male patient is initiated at 2.5 mg of Myalepta daily.
Maltese: Eżempju: pazjent raġel jinbeda fuq 2.5 mg ta' Myalepta kuljum.
English: One serious and severe infection of appendicitis was temporally associated with blocking activity against metreleptin in a patient with partial LD who was not in the subgroup of partial LD patients.
Maltese: Infezzjoni waħda serja u severa tal-appendiċite kienet assoċjata b'mod temporanju ma' attività ta' imblukkar kontra metreleptin f'pazjent b'LD parzjali li ma kienx fis-sottogrupp ta' pazjenti b'LD parzjali.
English: Patients were eligible for inclusion if they were > 6 months old, with a leptin level of < 12 ng/mL, and had at least 1 of the following 3 metabolic abnormalities:
Maltese: b'livell ta' leptin ta' < 12 ng/mL, u kellhom minn tal-inqas waħda minn dawn l-anormalitajiet metaboliċi li ġejjin:
English: Though not confirmed in clinical trials, neutralising antibodies could in theory affect the activity of endogenous leptin.
Maltese: Għalkemm mhux ikkonfermat fil-provi kliniċi, antikorpi newtralizzanti tista' teoretikament taffettwa llivelli endoġeni ta' leptin.
English: • If you are female and weigh more than 40 kg:
Maltese: • Jekk inti mara u tiżen aktar minn 40 kg:
English: Cases of T-cell lymphoma have been reported in clinical studies in patients taking Myalepta.
Maltese: Relazzjoni kawżali bejn limfoma u Myalepta ma ġietx stabbilita.
English: Individual patient once daily dose in mg = 2.5 mg Amount to inject once daily dose = 0.5 mL
Maltese: Doża ta' darba kuljum għal pazjent individwali f'mg = 2.5 mg
English: All reports of hypoglycaemia in patients with generalised LD and in the subgroup of partial LD patients, have been mild in nature with no pattern of onset or clinical sequelae.
Maltese: (4 fis-sottogrupp ta' pazjenti b'LD parzjali u 48 b'LD ġeneralizzata) irreġistrati u esposti għal metreleptin.
English: Package leaflet: Information for the patient Myalepta 3 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Maltese: Sabiex jiġi investigat aktar l-effett ta' Myalepta fuq kontroll metaboliku batut ġaladarba t-terapija fl-isfond tkun massimizzata
English: Starting daily dose (injection volume)
Maltese: Aġġustamenti fid doża (volum talinjezzjoni)