FrancophonIA/ELRC3.0 huggingface dataset:
English: For doses of: > 5 mg - 10 mg / > 1.0 mL volume daily
Maltese: Volum ta' kuljum ta' > 5 mg10 mg/> 1.0 mL
English: 21 gauge 40 mm needle
Maltese: Daqs ta' 21 Labra ta' 40 mm
English: 2.2 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Maltese: f'2.2 millilitri ta' ilma għall-injezzjonijiet, kull millilitru jkun fih 5 milligrammi ta' metreleptin.
English: o Neutralising antibodies may develop on Myalepta therapy.
Maltese: o Antikorpi newtralizzanti jistgħu jiżviluppaw waqt it-terapija b'Myalepta.
English: When starting therapy with Myalepta there is a risk of hypoglycaemia in patients who are on anti-diabetic medicinal products, in particular insulin or insulin secretagogues (see section 4.4).
Maltese: Meta tinbeda t-terapija b'Myalepta, ikun hemm ir-riskju ta' ipogliċemija f'pazjenti li jkunu fuq prodotti mediċinali kontra d-dijabete, b'mod partikulari insulina jew secretagogues tal-insulina (ara sezzjoni 4.4).
English: Among 15 patients in the partial LD subgroup who had a baseline TG level 5.65 mmol/L or greater and data available at Month 12, the mean (SD) baseline triglyceride level was 27.6 mmol/L (32.88) and the mean percent reduction in TGs at Month 12 was 53.7%.
Maltese: Fost 15-il pazjent fis-sottogrupp ta' LD parzjali li kellhom livell ta' TG fil-linja bażi ta' 5.65 mmol/L jew aktar, u dejta disponibbli f'Xahar 12, il-medja (SD) tal-livell tat-triglycerides fil-linja bażi kienet ta' 27.6 mmol/L (32.88) u t-tnaqqis perċentwali medju f'TGs f'Xahar 12 kien ta' 53.7%.
English: • Each vial contains 5.8 milligrams of metreleptin.
Maltese: • Kull kunjett fih 5.8 milligrammi ta' metreleptin.
English: Metreleptin works by copying the effects of leptin.
Maltese: Ġew studjati biss l-effetti metaboliċi ta' metreleptin.
English: Signs of an allergic reaction can be seen in section 4 under “Allergic reactions”.
Maltese: Sinjali ta' xi reazzjoni allerġika jinsabu f'sezzjoni 4 taħt “Reazzjonijijet allerġiċi”.
English: TGs for the generalised LD group were noted in all age groups with larger mean changes observed in the older age group (-42.9%) compared to the younger age groups (-10.5% and -14.1%).
Maltese: età kollha b'bidliet fil-medja akbar osservati fil-grupp ta' età akbar (-42.9%) meta mqabbla mal-gruppi ta' età iżgħar (-10.5% u -14.1%).
English: Needle gauge and length
Maltese: Meta wieħed jinsa jieħu doża
English: How to store Myalepta 6.
Maltese: Kif taħżen Myalepta 6.
English: Step B: Filling the 1 mL syringe with 0.6 mL of water for injections
Maltese: Pass B: Kif timla s-siringa ta' 1 mL b'0.6 mL ta' ilma għall-injezzjonijiet
English: • medicines for epilepsy or fits (such as phenytoin)
Maltese: • mediċini għall-epilessija jew aċċessjonijiet (bħal phenytoin)
English: • 0.5% HbA1c reduction and/or 25% reduction in insulin requirements and / or
Maltese: • tnaqqis ta' 0.5 % fl-HbA1c u/jew tnaqqis ta' 25 % fil-ħtiġijiet għall-insulina u/jew
English: Table 9 Primary outcome results in study (NIH 991265/ 20010769) of evaluable patients in the partial LD subgroup treated with metreleptin at 12 months
Maltese: Tabella 9 Riżultati primarji fi studju (NIH 991265/20010769) fis-sottogrupp ta' pazjenti b'LD
English: 0.156 mL 0.15 mL
Maltese: 0.156 mL
English: Each vial contains 5.8 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL)
Maltese: Kull kunjett fih 5.8 mg ta' metreleptin Wara r-rikostituzzjoni, kull mL ikun fih 5 mg ta' metreleptin (5 mg/mL)
English: • Each 0.05 mL is shown as a medium size line.
Maltese: • Kull 0.05 mL tidher bħala linja ta' daqs medju.
English: Step B: Filling the 3 mL syringe with 2.2 mL of water for injections
Maltese: Pass B: Kif timla s-siringa ta' 3 mL b'2.2 mL ta' ilma għall-injezzjonijiet
English: Studies in animals have shown some evidence of reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew xi evidenza ta' effett tossiku fuq is-sistema riproduttiva (ara 5.3).
English: • theophylline used in lung problems such as asthma
Maltese: • theophylline użat għal problemi fil-pulmun bħal ażżma
English: An example is given below for the different syringe sizes.
Maltese: Qed jingħata eżempju hawn taħt għaddaqsijiet tas-siringa differenti.
English: 25 kg patient is initiated at 0.06 mg/kg of Myalepta.
Maltese: Pazjent ta' 25 kg jinbeda fuq 0.06 mg/kg ta' Myalepta.
English: Males and females ≤ 40 kg
Maltese: Irġiel u nisa ≤ 40 kg
English: This will include for example instructions for handling possible ADRs.
Maltese: Din tinkludi pereżempju istruzzjonijiet għall-ġestjoni ta' ADRs possibbli.
English: Other medicines and Myalepta
Maltese: Mediċini oħra u Myalepta
English: • Patients/carers educational material
Maltese: • Materjal edukattiv għall-professjonisti fil-qasam mediku
English: Table 5 Conversion table for the 0.3 mL U100 insulin syringe Weight of child Dose of Myalepta
Maltese: Tabella 5 ta' konverżjoni għas-siringa tal-insulina ta' U100 0.3 mL Piż tat-tifel/tifla Doża ta' Myalepta L-ammont attwali tas-soluzzjoni*
English: Menorrhagia
Maltese: Pożoloġija
English: For doses of: ≤ 1.5 mg /≤ 0.3 mL volume daily
Maltese: Għal dożi ta: Volum ta' kuljum ta' ≤ 1.5 mg /≤ 0.3 mL
English: Patients/carers educational material should contain:
Maltese: - Gwida fil-materjali edukattivi dwar:
English: 1.1 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Maltese: f'1.1 millilitri ta' ilma għall-injezzjonijiet, kull millilitru jkun fih 5 milligrammi ta' metreleptin.
English: o Myalepta may increase fertility, due to effects on LH and thus the chances of unplanned pregnancy.
Maltese: o Myalepta jista' jżid il-fertilità, minħabba effetti fuq LH, u għalhekk il-probabbiltà ta' tqala mhux ippjanata.
English: LD patients with a blocking activity against metreleptin and concurrent infections responded to standard of care treatment (see section 4.4).
Maltese: Pazjenti b'LD attività ta' imblukkar kontra metreleptin u infezzjonijiet fl-istess ħin urew rispons għal trattament ta' standard ta' kura (ara sezzjoni 4.4).
English: • thigh
Maltese: • sogħla
English: 0.168 mL 0.16 mL
Maltese: 0.168 mL
English: Deep vein thrombosis
Maltese: Trombożi tal-vini profondi
English: − A starting dose is 5 mg (1 mL of solution).
Maltese: − Id-doża tal-bidu hija ta' 5 mg (1 mL ta' soluzzjoni).
English: • You will be given the 2.5 mL syringe to use if your daily dose is more than 5 mg up to 10 mg, which as a volume is greater than 1.0 mL of Myalepta solution.
Maltese: • Se tingħata s-siringa ta' 2.5 mL jekk id-doża tiegħek ta' kuljum hija ta' aktar minn 5 mg sa 10 mg, li bħala volum hija akbar minn 1.0 mL ta' soluzzjoni ta' Myalepta.
English: Step B: Filling the 3 mL syringe with 1.1 mL of water for injections
Maltese: Pass B: Kif timla s-siringa ta' 3 mL b'1.1 mL ta' ilma għall-injezzjonijiet
English: The most frequently occurring adverse reactions from the clinical studies were hypoglycaemia (14%) and weight decreased (17%).
Maltese: Ir-reazzjonijiet avversi li jseħħu l-aktar ta' spiss mill-istudji kliniċi kienu ipogliċemija (14%) u tnaqqis fil-piż (17%).
English: The individual patient dose = 0.9 mg. A dose increment of 0.02 mg/kg increases the daily dose to 0.08 mg/kg = 1.2 mg. Total daily volume to be injected is total dose in mg/5, in this case it is 1.2 mg/5 = 0.24 mL which equals 24 units on the 0.3 mL insulin syringe.
Maltese: Il-volum totali ta' kuljum li għandu jiġi injettat huwa doża totali f'mg/5, f'dan il-każ huwa 1.2 mg/5 = 0.24 mL li huwa ekwivalenti għal 24 unità fuq is-siringa tal-insulina ta' 0.3 mL.
English: Weight (kg) x 0.06 mg/kg = Individual patient daily starting dose in mg Weight (kg) x 0.012 mL/kg = Individual patient daily starting volume to inject in mL
Maltese: Piż (kg) x 0.06 mg/kg = doża inizjali ta' kuljum għal pazjent individwali f'mg Piż (kg) x 0.
English: Total daily volume to be injected is total dose in mg/5.
Maltese: Volum totali ta' kuljum biex jiġi injettat huwa doża totali f'mg/5.
English: Myalepta 5.8 mg powder for injection metreleptin
Maltese: Myalepta 5.8 mg trab għall-injezzjoni metreleptin
English: Prior to launch of Myalepta in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Myalepta f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH, Marketing Authorisation Holder) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi media tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Non-clinical data indicate renal clearance is the major route of metreleptin elimination, with no apparent contribution of systemic metabolism or degradation.
Maltese: Dejta mhux klinika tindika li t-tneħħija renali hija r-rotta ewlenija għall-eliminazzjoni ta' metreleptin, mingħajr l-ebda kontribuzzjoni apparenti tal-metaboliżmu sistemiku jew degradazzjoni.
English: Overall, the safety and tolerability of metreleptin are similar in children and adults.
Maltese: B'mod ġenerali, is-sigurtà u t-tollerabilità ta' metreleptin huma simili fit-tfal u f'persuni adulti.
English: 5) Withdraw 1.1 mL of water for injection into the 3 mL syringe.
Maltese: 5) Iġbed 1.1 mL ta' ilma għall-injezzjoni fis-siringa ta' 3 mL.
English: • The 3 mL syringe and needle will be provided separately.
Maltese: • Is-siringa ta' 3 mL u l-labra se jiġu pprovduti separatament.
English: Reproductive toxicity studies have not included toxicokinetics analysis.
Maltese: Studji dwar it-tossiċità fir-riproduzzjoni ma kinux jinkludu analiżi tossikokinetika.
English: Non-clinical data based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity reveal no risks additional to those attributed to an excess of the expected pharmacodynamic responses, such as loss of appetite and body weight.
Maltese: Dejta mhux klinika bbażata fuq studji konvenzjonali dwar is-sigurtà farmakoloġika, tossiċità ta' doża ripetuta u ġenotossiċità ma turi l-ebda riskji addizzjonali ma' dawk attribwiti għal eċċess tar-risponsi farmakodinamiċi mistennija, bħal nuqqas ta' aptit u telf ta' piż.
English: Dose of Myalepta
Maltese: Tużax Myalepta:
English: • having a high temperature
Maltese: • ikollok temperatura għolja
English: 4) Take the 3 mL syringe out of the plastic wrapper.
Maltese: 4) Oħroġ is-siringa ta' 3 mL mill-ippakkjar tal-plastik.
English: • Each vial contains 11.3 milligrams of metreleptin.
Maltese: • Kull kunjett fih 11.3 milligrammi ta' metreleptin.
English: ● Fasting TG concentration > 2.26 mmol/L or postprandially elevated triglycerides
Maltese: ● Konċentrazzjoni ta' TG fl-istat sajjem ta' > 2.26 mmol/L jew livelli għolja ta' trigylcerides wara l-ikel ta' > 5.65 mmol/L
English: The median duration of metreleptin treatment was 2.4 years (range: 6.7 months-14.0 years).
Maltese: It-tul medju tat-trattament b'metreleptin kien ta' 2.4 snin (medda: 6.7 xhur-14.
English: After IV administration, metreleptin clearance was shown to be 79.6 mL/kg/h in healthy volunteers.
Maltese: Wara l-għoti IV, it-tneħħija ta' metreleptin dehret li kienet ta' 79.6 mL/kg/siegħa f'voluntiera b'saħħithom.
English: Therefore, an additional non-hormonal contraceptive method should be considered during treatment.
Maltese: Għalhekk, metodu kontraċettiv mhux ormonali ieħor għandu jiġi kkunsidrat waqt it-trattament.
English: Myalepta 11.3 mg powder for injection metreleptin
Maltese: Myalepta 11.3 mg trab għall-injezzjoni metreleptin
English: Based on clinical response (e.g. inadequate metabolic control) or other consideration (e.g. tolerability issues, excessive weight loss especially in paediatric patients), the dose may be decreased, or increased to the maximum dose listed in Table 1.
Maltese: Abbażi tar-rispons kliniku (eż. kontroll metaboliku inadegwat) jew konsiderazzjoni oħra (eż. problemi ta' tollerabilità, telf eċċessiv fil-piż, speċjalment f'pazjenti pedjatriċi), id-doża jista' jkollha bżonn tiżdied jew titnaqqas sad-doża massima mniżżla f'Tabella 1.
English: 0.204 mL 0.20 mL
Maltese: 0.204 mL
English: o The risk of medication error: - Responsibility of the prescribing physician to provide appropriate training to the patient/carer who will administer the treatment and that the first dose should be administered in the presence of a doctor or nurse - The requirement to perform regular follow-ups with the patient/carer to ensure continued correct and compliant Myalepta reconstitution and treatment - Guidance on the appropriate syringe size ancillary administration set to prescribe according to the dosage of Myalepta and how to read the syringe volumes - How to access a video on line which shows step by step how to reconstitute, measure the correct dose and administer it subcutaneously o The association between LD and lymphoma and that the patient will be monitored during treatment.
Maltese: - Ir-responsabbiltà tat-tabib li jagħti l-preskrizzjoni li jipprovdi taħriġ xieraq lillpazjent/min jieħu ħsiebu/ha li se jagħti t-trattament, u li l-ewwel doża għandha tingħata fil-preżenza ta' tabib jew infermier - Il-ħtieġa li jsiru follow-ups regolari mal-pazjent/min jieħu ħsiebu/ha biex jiġi żgurat li r-rikostituzzjoni u t-trattament b'Myalepta jkomplu jkunu korretti u konformi - Gwida dwar id-daqs xieraq tas-siringa tas-sett ta' amministrazzjoni anċillari li għandu jiġi preskritt skont id-dożaġġ ta' Myalepta u kif jinqraw il-volumi tas-siringa - Kif taċċessa video online li juri pass pass kif tirrikostitwixxi, tkejjel id-doża korretta u tagħtiha taħt il-ġilda o L-assoċjazzjoni bejn LD u limfoma, u li l-pazjent se jiġi mmonitorjat waqt it-trattament.
English: 4) Take the 1 mL syringe out of the plastic wrapper.
Maltese: 4) Oħroġ is-siringa ta' 1 mL mill-ippakkjar tal-plastik.
English: 0.144 mL 0.14 mL
Maltese: 0.144 mL
English: • Remove the syringe from the plastic ampoule.
Maltese: • Neħħi s-siringa mill-ampulla tal-plastik.
English: T-cell lymphoma
Maltese: Limfoma taċ-ċelluli T
English: • with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.
Maltese: Simons), f'adulti u tfal ta' 12-il sena u aktar li għalihom trattamenti standard ma rnexxilhomx jiksbu kontroll metaboliku adegwat .
English: • you have ever had inflammation of an organ called the pancreas (‘pancreatitis')
Maltese: • jekk qatt kellek infjammazzjoni ta' organu imsejjaħ il-frixa (‘pankreatite')
English: • A dose card on which the doctor can write for the patient the dose in mg, ml (and where appropriate units from a 0.3 ml U100 insulin syringe).
Maltese: • Karta ta' dożaġġ li fuqha t-tabib jista' jikteb id-doża f'mg, mL (u fejn xieraq unitajiet minn siringa ta' 0.3 mL b'U100 insulina) għall-pazjent.
English: • with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above
Maltese: ġeneralizzata, (sindrome ta' Lawrence) akkwiżita f'adulti u tfal ta' sentejn u aktar
English: See the
Maltese: Doża ta'
English: - Guidance in the educational materials on: The size of syringes and needles to prescribe Prescribing the dose in both mg and ml and, where a 0.3 mL U100 insulin syringe is used, informing patients on the dose in "units" on the syringe to inject The prescribing of ampoule/vial sizes volumes of water for injection in appropriate volumes to reduce the risk of re-use Pharmacists will be guided in the educational materials on the ancillary items that need to be dispensed to patients including appropriate sized reconstitution and administration syringes and needles, appropriate sized vials/ampoules of water for injection, alcohol swabs and a sharps bin plus how to access Aegerion reconstitution and administration kits containing all of the above items except the water for injection and sharps bin.
Maltese: • Materjal ta' taħriġ għall-pazjenti/min jieħu ħsiebhom Il-Gwida/materjal ta' taħriġ għall-pazjenti/min jieħu ħsiebhom għandu jkun fihom lelementi ewlenin li ġejjin: o Noti ta' tfakkir dwar kontenut ta' informazzjoni ewlenija dwar preskrizzjoni, inkluż ilpopolazzjoni indikata, il-pożoloġija, twissijiet u prekawzjonijiet, u informazzjoni oħra relatata mas-sigurtà li hija importanti għall-użu sigur tal-prodott.
English: Myalepta 3 mg powder for injection metreleptin
Maltese: Myalepta 3 mg trab għall-injezzjoni metreleptin
English: 0.252 mL 0.25 mL
Maltese: 0.252 mL
English: 0.276 mL 0.27 mL
Maltese: 0.276 mL
English: These differences across age groups are likely related to differences in mean HbA1c at baseline, which was in the normal range for patients < 6 years (5.7%) and lower in patients ≥ 6 to < 12 years (6.4%) compared to the older age group (9.7%).
Maltese: Dawn id-differenzi fil-gruppi ta' età x'aktarx huma relatati ma' differenzi filmedja ta' HbA1c fil-linja bażi, li kienet fil-medda normali għal pazjenti ta' < 6 snin (5.7%) u inqas f'pazjenti ta' > 6 sa > 12-il sena (6.4%) meta mqabbla mal-grupp ta' età akbar (9.7%).
English: Name and address of the manufacturer of the biological active substance Sandoz GmbH - BP Kundl
Maltese: Sandoz GmbH - BP Kundl Biochemiestrasse 10 6250
English: 0.180 mL 0.18 mL
Maltese: 0.180 mL
English: ● Actual change from baseline in HbA1c at Month 12, and
Maltese: ● Bidla attwali mil-linja bażi f'HbA1c f'Xahar 12, u
English: • a glass ampoule
Maltese: • vista mċajpra
English: Among 45 patients with generalised LD who had a baseline HbA1c of 7% or greater and data available at Month 12, the mean (SD) baseline HbA1c was 9.6% (1.63) and the mean reduction in HbA1c at Month 12 was 2.8%.
Maltese: HbA1c fil-linja bażi ta' 7% jew aktar u dejta disponibbli f'Xahar 12, il-medja (SD) ta' HbA1c kienet ta' 9.6% (1.63) u t-tnaqqis medju f'HbA1c f'Xahar 12
English: • Pull up until the top rim of the plunger lines up with the black 2.2 mL line.
Maltese: • Iġbdu 'l isfel sakemm ix-xifer ta' fuq tal-planġer ikun bi dritt mal-linja sewda ta' 2.2 mL.
English: In the generalised LD group, mean decreases from baseline in HbA1c were noted in all age groups ≥ 6 years; the mean decreases to Month 12/last observation carried forward LOCF were similar in the two older age groups (-1.1% and -2.6%).
Maltese: kienu simili fiż-żewġ gruppi ta' età akbar (-1.1% u -2.6%).
English: These findings are considered to be related indirectly to metreleptin pharmacology, resulting in nutritional deprivation of treated animals, and also possibly, due to an inhibitory effect on spontaneous and oxytocin-induced contractions, as has been observed in strips of human myometrium exposed to leptin.
Maltese: Dawn is-sejbiet huma kkunsidrati li huma relatati b'mod indirett mal farmakoloġija ta' metreleptin, li jirriżultaw f'nuqqas ta' nutrizzjoni f'annimali ttrattati, u possibbilment ukoll, minħabba effett inibitorju fuq kontrazzjonijiet spontanji u kkawżati minn oxytocin, kif ġie osservat fi strixxi ta' myometrium uman esposti għal leptin.
English: Each vial contains 11.3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL)
Maltese: Kull kunjett fih 11.3 mg ta' metreleptin Wara r-rikostituzzjoni, kull mL ikun fih 5 mg ta' metreleptin (5 mg/mL)
English: • The 1 mL syringe and needle will be provided separately.
Maltese: • Is-siringa ta' 1 mL u l-labra se jiġu pprovduti separatament.
English: Reading the syringe
Maltese: DATA TA' SKADENZA
English: 0.108 mL 0.10 mL
Maltese: 0.108 mL
English: 30 vials
Maltese: 1 kunjett 30 kunjett
English: In the generalised LD group, the number of patients according to age group was as follows: 5 patients < 6 years (including a single patient < 2 years), 12 patients ≥ 6 to < 12 years and 28 patients aged ≥ 12 to < 18 years; in the partial LD subgroup, there were no patients < 12 years of age and 4 patients ≥ 12 to < 18 years.
Maltese: < 6 snin (inkluż pazjent wieħed ta' < sentejn), 12-il pazjent ta' ≥ 6 sa < 12-il sena u 28 pazjent li kellhom ≥ 12-il sena < 18-il sena; fis-sottogrupp ta' LD parzjali, ma kien hemm l-ebda pazjenti li kellhom < 12-il sena, u 4 pazjenti li kellhom ≥ 12 sa < 18-il sena.
English: 0.288 mL 0.28 mL
Maltese: 0.288 mL
English: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/blue 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 talplastik blu.
English: Example: A 15 kg patient is initiated at 0.06 mg/kg of Myalepta.
Maltese: Eżempju: pazjent ta' 15 kg jinbeda fuq 0.06 mg/kg ta' Myalepta.
English: In this case, prolonged overdose was associated with severe anorexia causing vitamin and zinc deficiencies, iron deficiency anaemia, protein calorie malnutrition, and poor weight gain, which resolved following supportive treatment and dose adjustment.
Maltese: F'dan il-każ, doża eċċessiva fit-tul kienet assoċjata ma' anoressija severa li tikkawża defiċjenzi ta' vitamini u żingu, anemija minħabba defiċjenzi ta' ħadid, malnutrizzjoni tal-kaloriji tal-proteini, u żieda baxxa fil-piż, li għaddew wara trattament ta' sostenn u aġġustament fid-doża.
English: Multiple dosing regimens were explored during the NIH study, which led to the posology recommended in section 4.2.
Maltese: Korsijiet ta' dożaġġ multiplu ġew esplorati matul l-istudju NIH, li wassal għall-pożoloġija rakkomandata f'sezzjoni 4.2.
English: 0.192 mL 0.19 mL
Maltese: 0.192 mL
English: Safety and efficacy data were analysed in a subgroup of partial LD patients with the following characteristics: 12 years of age and above with leptin levels < 12 ng/mL, TG ≥ 5.65 mmol/l and/or
Maltese: Id-dejta dwar is-sigurtà u l-effikaċja ġiet analizzata f'sottogrupp ta' pazjenti b'LD parzjali bil karatteristiċi li ġejjin: kellhom 12-il sena u aktar b'livelli ta' leptin ta' < 12 ng/mL, TG ≥ 5.65 mmol/l u/jew HbA1c ≥ 8%.
English: Following single subcutaneous doses of 0.01 to 0.3 mg/kg metreleptin in healthy adult subjects, the half-life was 3.8 to 4.7 hours.
Maltese: Wara dożi waħidhom taħt il-ġilda ta' 0.01 sa 0.3 mg/kg ta' metreleptin f'individwi adulti b'saħħithom, il-half-life kien ta' 3.8 sa 4.7 sigħat.
English: The greater metreleptin exposure and longer t1/2 observed in the pregnant animals may be related to a reduced elimination capacity by binding to soluble leptin receptor found at higher levels in pregnant mice.
Maltese: L-ikbar esponiment ta' metreleptin u l-itwal t1/2 osservati f'annimali tqal jistgħu jkunu relatati ma' kapaċità ta' eliminazzjoni mnaqqsa billi jingħaqdu ma' riċettur ta' leptin solubbli li nstab f'livelli ogħla fi ġrieden tqal.
English: The median age at baseline was 38 years (range: 15-64 years), with 5 (16%) patients being less than 18 years of age.
Maltese: L-età medjana fil-linja bażi kienet ta' 38 sena (medda: (15-64 sena), b'5 (16%) pazjenti li kellhom inqas minn 18-il sena.
English: Serious and/or severe infections that were temporally associated with > 80% blocking activity against metreleptin occurred in 5 generalised LD patients.
Maltese: Infezzjonijiet serji u/jew severi li kienu assoċjati b'mod temporanju ma' >80% attività ta' imblukkar kontra metreleptin, seħħew f'5 pazjenti b'LD ġeneralizzata.
English: • If there is less than 1.1 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 1.1 mL in the syringe.
Maltese: • Jekk hemm inqas minn 1.1 mL ta' ilma għall-injezzjoni fis-siringa, tiġbed aktar ilma għallinjezzjoni ġos-siringa u rrepeti l-passi 6 u 7 sakemm ikollok 1.1 mL fis-siringa.
English: - HCPs should provide training to patients on the correct technique.
Maltese: - Professjonisti fil-qasam mediku għandhom jipprovdu taħriġ lill-pazjenti dwar it teknika korretta.
English: The median age at baseline was 15 years (range: 1-68 years), with 45 (68%) patients being less than 18 years of age.
Maltese: (medda: (1-68 sena), b'45 (68%) pazjent li kellhom inqas minn 18-il sena.
English: Of the 31 partial LD subgroup patients evaluated, 27 (87%) had familial partial LD and 4 (13%) had acquired partial LD.
Maltese: Mit-31 pazjent fis-sottogrupp ta' LD parzjali evalwati, 27 (87%) kellhom