FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs of low blood sugar are: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea and fast or irregular heartbeats.
Maltese: Sinjali ta' livelli ta' zokkor fid-demm baxx huma: sturdament, għeja, irrikwitezza, ġuħ, irritabilità, mhux faċli tikkonċentra, għaraq, nawsja u taħbit qawwi jew irregolari tal-qalb.
English: Mean (SD)
Maltese: Assago (Mi)
English: One ml contains 10 mg of mecasermin.
Maltese: U KWANTITATTIVA Kull ml fih 10 mg ta' mecasermin*.
English: Intracranial hypertension/increased intracranial pressure occurred in 4 (0.96%) of patients from the clinical trials and occurred in 7 - 9 year old treatment naïve subjects.
Maltese: Il-pressjoni għolja ġol-kranju/żieda fil-pressjoni ġol-kranju seħħet f'4 pazjenti (0.96%) mill-provi kliniċi u seħħet f'individwi b'età ta' 7 - 9 snin li qatt ma ħadu kura qabel.
English: How to store INCRELEX
Maltese: Tieħux INCRELEX
English: Organ growth: treatment of IGF-1 deficient rats with rhIGF-1 results in whole body and organ growth.
Maltese: Żvilupp tal-organi: trattament ta' firien defiċjenti minn IGF-1 b'rhIGF-1 irriżulta fi żvilupp tal-ġisem kollu u tal-organi.
English: In blood, IGF-1 is bound to six IGF binding proteins (IGFBPs), with ~80% bound as a complex with IGFBP-3 and an acid-labile subunit.
Maltese: Fid-demm, IGF-1 huwa marbut ma' sitt proteini tal-irbit ta' IGF, bi 80% marbut bħala kumpless ma' IGFBP-3 u sottounità li hi acid-labile.
English: The amino acid sequence of the product is identical to that of endogenous human IGF-1.
Maltese: Is-sekwenza ta' aċidi amminiċi tal-prodott hija identika ma dik ta' IGF-1 endoġenu uman.
English: Race No information is available.
Maltese: Razza L-ebda informazzjoni disponibbli.
English: IGF-1 suppresses hepatic glucose production, stimulates peripheral glucose utilization, and can reduce blood glucose and cause hypoglycaemia.
Maltese: IGF-1 iwaqqaf il-produzzjoni ta' glukows epatiku, jistimula l-użu periferali tal-glukows, u jista' jnaqqas il-glukows fid-demm u jikkaġuna ipogliċemija.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Maltese: Ma dehrux effetti mhux mixtieqa waqt studji kliniċi, iżda dehru f'annimali f'livelli ta' esponiment simili għal livelli ta' esponiment kliniku u b'rilevanza possibbli għall-użu kliniku, kif spjegat:
English: Mecasermin has been tested in a rat teratology study with no effects on fœtus up to 16 mg/kg (20 fold the maximum recommended human dose (MRHD) based on body surface area) and in a rabbit teratology with no effects on foetus at dose of 0.5 mg/kg (2 fold the MRHD based on body surface area).
Maltese: Mecasermin ġie ttestjat fi studju teratoloġiku fuq il-firien b'ebda effetti fuq il-fetu sa 16 mg/kg (20 darba d-doża massima rrakkomandata fil-bniedem (MRHD - maximum recommended human dose) ibbażat fuq l-erja superfiċjali tal-ġisem) u fi studju teratoloġiku fuq il-fniek b'ebda effetti fuq il-fetu b'doża ta' 0.5 mg/kg (darbtejn l-MRHD ibbażat fuq l-erja superfiċjali tal-ġisem).
English: For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).
Maltese: Għat-trattament fuq tul ta' żmien ta' nuqqas ta' żvilupp fit-tfal u l-adolexxenti minn età ta' 2 sa 18-il sena b'defiċjenza primarja severa tal-fattur tal-iżvilupp-1 li jixbaħ l-insulina (IGFD Primarja).
English: There are limited data concerning the pharmacokinetics of mecasermin in children with renal impairment, in this specific population of severe primary IGFD patients.
Maltese: Hemm dejta limitata rigward il-farmakokinetiċi ta' mecasermin fi tfal b'indeboliment renali, f'din ilpopolazzjoni speċifika ta' pazjenti b'IGFD primarja severa.
English: Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced (see section 4.4).
Maltese: Dożi ta' insulina u/jew prodotti mediċinali oħra ipogliċemiċi għandhom mnejn ikollhom jiġu mnaqqsa (ara sezzjoni 4.4).
English: During clinical trials in other indications (totaling approximately 300 patients) 8% of patients reported a local and/or systemic hypersensitivity reactions.
Maltese: Matul il-provi kliniċi f'indikazzjonijiet oħra (b'total ta' madwar 300 pazjent) 8% tal-pazjenti rrappurtaw reazzjonijiet ta' sensittività eċċessiva lokali u/jew sistemika.
English: The total IGF-1 volume of distribution (mean ± SD) after subcutaneous administration of INCRELEX in 12 subjects with severe Primary IGFD is estimated to be 0.257 (± 0.073) l/kg at a mecasermin dose of 0.045 mg/kg, and is estimated to increase as the dose of mecasermin increases.
Maltese: Il-volum ta' distribuzzjoni ta' IGF totali (medja ± SD) fi 12-il suġġett b'IGFD Primarja severa wara injezzjoni taħt il-ġilda ta' INCRELEX huwa kkalkulat li huwa 0.257 (± 0.073) l/kg f'doża ta' mecasermin ta' 0.045 mg/kg, u huwa kkalkulat li jiżdid hekk kif tiżdied id-doża ta' mecasermin.
English: This may be through the production of anti-IGF-1 IgEs, sustaining antibodies or neutralizing antibodies respectively.
Maltese: IGF-1, antikorpi li jsostnu jew antikorpi newtralizzanti rispettivament.
English: INCRELEX contains benzyl alcohol as a preservative which may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Maltese: INCRELEX fih benzyl alkoħol bħala preservattiv li jista' jikkaġuna reazzjonijiet tossiċi u reazzjonijiet allerġiċi fit-trabi u tfal sa età ta 3 snin.
English: Via del Bosco Rinnovato n. 6 Milanofiori Nord Palazzo U7 20090 Assago (Mi) Tel: + 39 - 02 - 39 22 41
Maltese: 6 Milanofiori Nord Palazzo U7 20090
English: Subcutaneous doses of mecasermin, generally ranging from 60 to 120 g/kg given twice daily (BID), were administered to 92 paediatric subjects with severe Primary IGFD.
Maltese: Dożi ta' mecasermin mogħtija taħt il-ġilda, ġeneralment ivarjaw minn 60 sa 120 g/kg mogħtija darbtejn kuljum (BID), kienu mogħtija lil 92 suġġett pedjatriku b'IGFD Primarja severa.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jista' jaffetwa sa persuna 1 minn kull 100)
English: • To inform parents and patients that systemic allergic reactions are possible and that if this occurs treatment should be interrupted and prompt medical attention should be sought.
Maltese: • Sabiex jinforma lill-ġenituri u l-pazjenti li reazzjonijiet allerġiċi sistematiċi huma possibbli u jekk dawn iseħħu t-trattament għandu jiġi interrot u attenzjoni medika filpront għandha tiġi mfittxija.
English: Other adverse reactions have been identified during post approval use of INCRELEX.
Maltese: Reazzjonijiet avversi oħra ġew identifikati matul l-użu wara l-approvazzjoni ta' INCRELEX.
English: Reactions including pain, irritation, bleeding, bruising, redness and hardening have been reported with INCRELEX treatment.
Maltese: Reazzjonijiet li jinkludu uġigħ, iritazzjoni, fsada, tbenġil, ħmura u twebbis ġew irrappurtati bi trattament b'INCRELEX.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40mg/4ml
Maltese: Kunjett wieħed ta' użu multiplu ta' 4 ml. 40mg/4ml
English: Buttock
Maltese: Mecasermin
English: Release the skin (see Figure A).
Maltese: Itlaq l-ġilda (ara Figura A).
English: Pre-treatment height velocity data were available for 75 subjects.
Maltese: Kien hemm dejta tal-veloċità tat-tul ta' qabel it-trattament għal 75 suġġett.
English: Height Velocity (cm/yr)
Maltese: Veloċità tat-tul (ċm/sena) N (SD) Medja
English: Height SDS
Maltese: SDS tat-Tul
English: Of the 115 (28%) subjects who experienced one or more episode of hypoglycaemia, 6 subjects experienced a hypoglycaemic seizure on one or more occasion.
Maltese: Mill-115-il suġġett (28%) li kellhom episodju wieħed jew iżjed ta' ipergliċemija, 6 suġġetti kellhom aċċessjoni ipogliċemika darba jew iżjed minn darba.
English: 5.2 Pharmacokinetic properties
Maltese: .2 Tagħrif Farmakokinetiku
English: Reproductive system and breast disorders
Maltese: Disturbi fis-Sistema Riproduttiva u fis-Sider
English: There are limited data concerning the pharmacokinetics of mecasermin in children with hepatic impairment, in this specific population of severe primary IGFD patients.
Maltese: Hemm dejta limitata rigward il-farmakokinetiċi ta' mecasermin fi tfal b'indeboliment epatiku, f'din ilpopolazzjoni speċifika ta' pazjenti b'IGFD primarja severa.
English: Under normal circumstances, growth hormone (GH) binds to its receptor in the liver and other tissues, and stimulates the synthesis/secretion of IGF-1.
Maltese: Taħt cirkustanzi normali, l-ormon tal-iżvilupp (GH) jintrabat mar-riċettur tiegħu fil-fwied u tessuti oħra, u jistimula t-tnixxija/sintesi ta' IGF-1.
English: During clinical trials in other indications totalling approximately 300 patients, reports of local and/or systemic hypersensitivity were received for 8% of patients.
Maltese: Matul il-provi kliniċi f'indikazzjonijiet oħra ta' total ta' madwar 300 pazjent, kien hemm rapporti ta' sensittività eċċessiva lokali u/jew sistemika għal 8% mill-pazjenti.
English: The vial contains 4 ml of solution.
Maltese: Il-fjala fiha 4 ml ta' soluzzjoni.
English: Figure 4: Tip in liquid
Maltese: Figura 4: It-tarf fil-likwidu
English: In target tissues the Type 1 IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signaling which stimulates multiple processes leading to statural growth.
Maltese: Fit-tessuti bersalljati r-riċettur IGF-1 Tip 1, li huwa omologu għar-riċettur tal-insulina, huwa attivat minn IGF-1, u jwassal għal sinjalar intraċellolari li jistumula proċessi multipli li jwasslu għal żvilupp staturali.
English: Among all subjects included for safety evaluation (n=92), 83% of the subjects reported at least one adverse event during the course of the studies.
Maltese: Fost l-individwi kollha inklużi għall-evalwazzjoni tas-sigurtà (n = 92), 83% tal-individwi rrappurtaw għallinqas avveniment avvers wieħed matul il-kors tal-istudji.
English: Of these, 72 (89%) had Laron syndrome-like phenotype; 7 (9%) had GH gene deletion, 1 (1%) had neutralizing antibodies to GH and 1 (1%) had isolated genetic GH deficiency.
Maltese: 27.9; SDS ta' IGF-1: -4.2  2.0; u età tal-għadam (snin): 3.8  2.8. Minn dawn, 72 (89%) kellhom fenotip bħas-sindrome ta' Laron; 7 (9%) kellhom eliminazzjoni tal-ġene tal-GH, 1 (1%) kellu antikorpi newtralizzanti għal GH u 1 (1%) kellu defiċjenza ġenetika iżolata tal-GH. Sitta u erbgħin (57%) mis-suġġetti kienu rġiel; 66 (81%) kienu Kawkasi.
English: Musculoskeletal and connective Very common: Arthralgia, pain in tissue disorders extremity Common: Scoliosis, myalgia
Maltese: Komuni ħafna: Artralġja, uġigħ fl-estremitajiet Komuni: Skoljosi, majalġja
English: Each vial of 4 ml contains 40 mg of mecasermin*.
Maltese: Kull kunjett ta' 4 ml fih 40 mg ta' mecasermin*.
English: Systemic hypersensitivity included symptoms such as anaphylaxis, generalized urticaria, angioedema and dyspnoea.
Maltese: Sensittività eċċessiva sistemika inkludiet sintimi bħall-anafilassi, urtikarja ġeneralizzata, anġjoedima u qtugħ ta' nifs.
English: Very common: Otitis media Common: Hypoacusis, ear pain, middle ear effusion
Maltese: Otitis media Komuni: Ipoakusi, uġigħ filwidna, fluwidu fil-widna tannofs
English: Table 2: Annual Height Results by Number of Years Treated with INCRELEX Pre-Tx Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8
Maltese: Pre-Tx Sena 1 Sena 2 Sena 3 Sena 4 Sena 5
English: • The signs and symptoms of hypoglycaemia.
Maltese: • Is-sinjali u s-sintomi ta' ipogliċemija.
English: In rats and rabbits reproductive toxicity was studied after intravenous but not after subcutaneous application (the normal clinical route).
Maltese: Tossiċità riproduttiva fil-firien u fil-fniek kienu studjati wara applikazzjoni ġol-vina iżda mhux wara applikazzjoni taħt il-ġilda (ir-rotta klinika normali).
English: Frequency not known (frequency cannot be estimated from the available data) Serious allergic reactions (anaphylaxis)
Maltese: Frekwenza mhux magħrufa (frekwanza ma tistax tiġi stmata mid-dejta disponibbli) Reazzjonijiet allerġiċi serji (anafilassi)
English: The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.
Maltese: Parti mill-effetti metaboliċi ta' IGF-1 huma diretti li jistumulaw it-teħid ta' glukows, aċidi grassi, u aċidi amminiċi sabiex il-metaboliżmu jsostni lit-tessuti li jkunu qegħdin jikbru.
English: Seizures (fits) have been observed with mecasermin treatment.
Maltese: Uġigħ fil-muskoli ġie osservat ukoll bi trattament ta' mecasermin.
English: - INCRELEX is a liquid that contains mecasermin which is a man-made insulin-like growth factor-1 (IGF-1), which is similar to the IGF-1 made by your body.
Maltese: - INCRELEX huwa likwidu li fih il-mecasermin li huwa fattur tal-iżvilupp-1 (IGF-1) magħmul mill-bniedem li jixbaħ l-insulina umana, li jixbaħ ħafna l-IGF-1 magħmul f'ġismek.
English: Pharmacodynamic effects The following actions have been demonstrated for endogenous human IGF-1:
Maltese: Ir-reazzjonijiet li ġejjin ġew murija għal IGF-1 endoġenu uman:
English: • INCRELEX is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops.
Maltese: • INCRELEX huwa kontra-indikat fil-preżenza ta' neoplasja suspettuża jew attiva, u tterapija għandha titwaqqaf jekk ikun hemm evidenza li tiżviluppa n-neoplasja.
English: Tonsillar hypertrophy
Maltese: Ipertrofija fis-sit tal-injezzjoni
English: Figure 2: Inject air into vial
Maltese: Figura 2: Injetta arja ġol-fjala
English: Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
Maltese: IGFD Primarja Severa tinkludi pazjenti b'mutazzjonijiet fir-riċettur ta' GH (GHR), fil-mogħdija tas-senjalar ta' wara-GHR, u difetti fil-ġene IGF-1; huma mhumiex defiċjenti mill-GH, u għaldaqstant, mhux mistennija li jirreaġixxu adegwatament għal trattament bi GH eżoġenu.
English: An increased incidence of keratoacanthoma in the skin was observed in male rats at doses of 4 and 10 mg/kg/day ( 4 times the exposure with the MRHD based on AUC).
Maltese: Żieda fl-inċidenża ta' keratoakantoma fil-gilda kienet osservata fil-firien irġiel f'dożi ta' 4 u 10 mg/kg/kuljum ( 4 darbiet l-esponiment bl-MRHD ibbażat fuq l-AUC).
English: Reproductive system Breast enlargement has been observed with mecasermin treatment.
Maltese: Sistema Riproduttiva Ġie osservat tkabbir tas-sider b'kura b'mecasermin.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodju (23 mg) f'kull fjala, jiġifieri huwa essenjalment ‘ħieles mis-sodju'.
English: Common: Abdominal pain
Maltese: Komuni: Uġigħ addominali
English: In adolescents with Primary IGFD and in healthy adults there were no apparent differences between males and females in the pharmacokinetics of INCRELEX.
Maltese: F'adolexxenti li għandhom IGFD primarja u f'adulti b'saħħithom ma dehrx li kien hemm differenzi filfarmakokinetiċi ta' INCRELEX bejn irġiel u nisa.
English: Patients with abnormal echocardiogram findings or cardiovascular symptoms should be followed regularly with echocardiogram procedures.
Maltese: Pazjenti b'riżultati ta' ekokardjogramma abnormali jew sintomi kardjovaskulari għandhom jkunu segwiti regolarment bi proċeduri ta' ekokardjogramma.
English: Used needle and syringe should be placed in a sharps container (such as a biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can).
Maltese: Armihom kif suppost f'kontenuitur għal oġġetti li jaqtgħu (bħal kontenitur għal perikli bijoloġiċi), kontenitur tal-plastik iebes (bħal flixkun tad-deterġenti), jew kontenitur tal-metall (bħal landa tal-kafe vojta).
English: This reaction occurred in 71 (17%) subjects from the clinical trials and was generally associated with lack of proper rotation of injections.
Maltese: Din ir-reazzjoni seħħet f'71 suġġett (17%) mill-provi kliniċi u ġeneralment kienet assoċjata ma' nuqqas ta' rotazzjoni tajba tal-injezzjonijiet.
English: The mean terminal t1/2 of total IGF-1 after single subcutaneous administration of 0.12 mg/kg in three paediatric subjects with severe Primary IGFD is estimated to be 5.8 hours.
Maltese: 12 mg/kg mogħtija taħt il-ġilda fi tliet suġġetti pedjatriċi b'IGFD primarja severa hija kkalkulata li hija 5.8 sigħat.
English: From a microbiological point of view, once opened, the medicinal product may be stored for a maximum of 30 days at 2C to 8C.
Maltese: Mil-lat mikrobijoloġiku, la darba jkun miftuħ, il-prodott mediċinali jrid jiġi maħżun għal massimu ta' 30 jum f'temperatura ta' 2C sa 8C.
English: Wipe the rubber stopper of the vial with an alcohol swab to prevent contamination of the vial by germs that may be introduced by repeated needle insertions (see Figure 1).
Maltese: Imsaħ it-tapp tal-lastku tal-fjala b'tajjar bl-alkoħol sabiex tiġi evitata l-kontaminazzjoni tal-fjala b'mikrobi li jistgħu jiġu introdotti b'inserzjonijiet ripetuti tal-labra (ara Figura 1).
English: Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with mecasermin, as has been reported with therapeutic GH administration.
Maltese: Pressjoni għolja fil-kranju (IH) b'papilledima, tibdil viżwali, uġigħ ta' ras, nawsja u/jew rimettar ġew irrapportati f'pazjenti ttrattati b'mecasermin, kif ġew ukoll irrapportati b'amministrazzjoni terapewtika ta' GH. Sinjali u sintomi assoċjati ma' IH irrisolvew wara t-twaqqif tal-iddożar.
English: Placental transfer of mecasermin was not studied.
Maltese: Trasferiment ta' mecasermin mis-sekonda ma kienx mistħarreġ.
English: An increased incidence of adrenal medullary hyperplasia and pheochromocytoma was observed in male rats at doses of 1 mg/kg/day and above ( 1 times the clinical exposure with the maximum recommended human dose [MRHD] based on AUC) and female rats at all dose levels ( 0.3 times the clinical exposure with the MRHD based on AUC).
Maltese: Żieda fl-inċidenża ta' iperplażja tal-medulla adrenali u fejokromoċitoma kienet osservata fil-firien irgiel f'dożi ta' 1mg/kg/kuljum u ogħla ( 1 darba l-esponiment kliniku bid-doża umana massima rakkomandata
English: No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin.
Maltese: Kien hemm ukoll rapporti ta' reazzjonijiet allerġiċi lokali fis-sit talinjezzjoni.
English: Beaufour Ipsen Industrie
Maltese: Figura 3: Ipprepara biex testratta
English: For further information ask the doctor.
Maltese: Sorsi oħra ta' informazzjoni
English: Circulating IGF-1 plays an important role in the acquisition and maintenance of bone mass. IGF-1 increases bone density.
Maltese: IGF-1 fiċ-ċirkulazzjoni għandu rwol importanti fil-kisba u l-manteniment tal-massa tal-għadam.
English: Thigh
Maltese: Treddigħ
English: Nervous system Headache has occurred with mecasermin treatment.
Maltese: Sistema nervuża Seħħ uġigħ ta' ras b'kura b'mecasermin.
English: Hair loss (alopecia)
Maltese: Jaqa' x-xagħar (alopeċja)
English: Mean (SD) -6.9 (1.8) -6.1
Maltese: 1  15.8; punteġġ ta' devjazzjoni standard tat-tul (SDS): -6.9  1.8; veloċità tat-tul (ċm/sena): 2.6  1.7; SDS tal-veloċità tat-tul: -3.4  1.6;
English: Before you take the needle out of the vial, check the syringe for air bubbles.
Maltese: F'każijiet bħal dawn, għandhom jiġu kkunsidrati testijiet ta' antikorpi.
English: 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakoloġiċi
English: These conditions should be monitored during INCRELEX treatment.
Maltese: Dawn il-kundizzjonijiet għandhom jiġu monitorati waqt it-trattament b'INCRELEX.
English: INSTRUCTIONS ON USE
Maltese: Dejta mhux disponibbli
English: Hypoacusis (hearing loss)
Maltese: Ipoakusi (telf ta' smigħ)
English: This was noted in 38 (9%) subjects, particularly in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years.
Maltese: Din ġiet innotata f'38 suġġett (9%), b'mod partikolari fl-ewwel sena sa sentejn tat-terapija bi tnaqqis fit-tkabbir tat-tunsilli fis-snin ta' wara.
English: Insulin-like growth factor-1 (IGF-1) is the principal hormonal mediator of statural growth.
Maltese: Il-fattur-1 tal-iżvilupp li jixbaħ lill-insulina (IGF-1) huwa l-medjatur ormonali prinċipali tal-iżvilupp staturali.
English: - Keep this leaflet.
Maltese: REAZZJONIJIET AVVERSI.
English: • To educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Maltese: • Li jeduka lil ġenituri dwar is-sinjali, sintomi u trattament tal-ipogliċemija, li jinkludi l-injezzjoni ta' glucagon.
English: Infections Infections of the middle ear have been observed in children with mecasermin treatment.
Maltese: Aċċessjonijiet kienu osservat bi trattament ta' mecasermin.
English: Musculoskeletal system Joint pains and pains in the limbs have occurred with mecasermin treatment.
Maltese: Sistema muskolu-skeletrika Seħħ uġigħ fil-ġogi u uġigħ fir-riġlejn u d-dirgħajn b'kura b'mecasermin.
English: IGF-1 has inhibitory effects on insulin secretion.
Maltese: IGF-1 għandu effetti inibitorji fuq it-tnixxija tal-insulina.
English: Mecasermin may be started again after the episode is over.
Maltese: Mecasermin jista' jerġa jinbeda mill-ġdid wara li jkun għadda l-episodju.
English: Each vial contains 40 mg of mecasermin.
Maltese: Kull kunjett fih 40 mg ta' mecasermin.
English: Treatment with mecasermin is a long-term therapy.
Maltese: It-trattament b'mecasermin huwa terapija fuq perijodu ta' żmien twil.
English: Excess mortality secondary to IGF-1 induced hypoglycaemia was observed in the carcinogenesis studies.
Maltese: Eċċess ta' mortalità sekondarja minn ipogliċemija ikkaġunata minn IGF-1 kienet osservata fl-istharriġ talkarċinoġenesi.
English: Acute overdose could lead to hypoglycaemia.
Maltese: HUWA SUĠĠETT GĦAL MONITORAĠĠ ADDIZZJONALI.
English: Instructions on the treatment of hypoglycaemia.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni.
English: Mecasermin, like insulin, may lower blood sugar levels (see hypoglycaemia in section 4).
Maltese: Mecasermin, bħall-insulina, jista' jbaxxi l-livelli taz-zokkor fid-demm (ara ipogliċemija fis-sezzjoni
English: Figure 6: Remove air bubbles and refill syringe
Maltese: Figura 7: Lest biex tinjetta
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (not known).
Maltese: Minħabba li dawn irreazzjonijiet huma rrappurtati volontarjament minn popolazzjoni ta' daqs inċert, mhuwiex possibbli li ssir stima affidabbli tal-frekwenza tagħhom (mhumiex magħrufa).
English: Lymphoid tissue (e.g., tonsillar) hypertrophy associated with complications, such as snoring, sleep apnoea, and chronic middle-ear effusions have been reported with the use of this medicinal product.
Maltese: Ipertrofija ta' tessut limfojdi (eż., tat-tunsilli) assoċjat ma' kumplikazzjonijiet, bħal ma huma nħir, apnija ta' waqt l-irqad, u effużjonijiet kroniċi fil-parti tan-nofs tal-widna ġew irrapportati bl-użu ta' dan il-prodott mediċinali.
English: Common (may affect up to 1 in 10 people) Seizures
Maltese: Komuni ħafna (li jistgħu jseħħu f'aktar minn 1 minn kull 10)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION INCRELEX 10 mg/ml injection mecasermin
Maltese: U MNEJN GĦANDU JINGĦATA INCRELEX 10 mg/ml injezzjoni mecasermin
English: Stop INCRELEX immediately and seek urgent medical advice if you develop seizures/fits or become unconscious.
Maltese: Waqqaf INCRELEX immedjatament u fittex parir mediku urġenti jekk ikollok aċċessjonijiet jew tintilef min-sensik.
English: Common: Injection site pain, injection site reaction, injection site haematoma, injection site erythema, injection site induration, injection site haemorrhage, injection site irritation
Maltese: Komuni: Sindrome tal-apnea waqt l-irqad, ipertrofija adenojdali, ipertrofija tattunsilli, inħir