FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains 52 mg of sodium per daily dose equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 52 mg sodium f'kull doża ekwivalenti għal 2.6% tal-ammont massimu rakkomandat mill-WHO ta 2 g sodium li għandu jittieħed kuljum minn adult.
English: Budesonide undergoes extensive biotransformation by CYP3A4 in the mucosa of the small intestine and in the liver to metabolites of low glucocorticosteroid activity.
Maltese: Budesonide jgħaddi minn bijotrasformazzjoni estensiva permezz ta' CYP3A4 fil-mukuża tal-musrana ż-żgħira u fil-fwied għal metaboliti li għandhom attività kortikosterojde baxxa.
English: Cushing's syndrome, adrenal suppression, growth retardation in children Metabolism and nutrition disorders Hypokalaemia, hyperglycaemia Psychiatric disorders
Maltese: Sindrome ta' Cushing, soppressjoni adrenali, dewmien fl iżvilupp fit-tfal
English: Jorveza could affect the results of adrenal function tests (ACTH stimulation test) ordered by your doctor or in hospital.
Maltese: Jorveza jista' jaffettwa r-riżultati tat-testijiet tal-funzjoni adrenali (test ta' stimulazzjoni ta' ACTH)
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 °C.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1.
English: Glucocorticosteroids may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis and reduce the stress response.
Maltese: Il-glukokortikosterojdi jistgħu jikkawżaw soppressjoni tal-assi ipotalmika-pitwitarja-adrenali (HPA, hypothalamic-pituitary-adrenal) u tnaqqis fir-rispons għall-istress.
English: The usual duration of treatment is 6 weeks.
Maltese: Il-kura normalment iddum 6 ġimgħat.
English: Fertility was unaffected following budesonide treatment in animal studies (see section 5.3).
Maltese: Fi studji bl-annimali, ilfertilità ma kinitx affettwata wara l-kura b'budesonide (ara sezzjoni 5.3).
English: Vifor Pharma Nordiska AB Tlf: +46 8 5580 6600 info.nordic@viforpharma.com
Maltese: Tlf: +46 8 5580 6600 info.nordic@viforpharma.com
English: Esophageal candidiasis Oral and/or oropharyngeal candidiasis
Maltese: Kandidjażi orali u/jew orofarinġali
English: − tuberculosis
Maltese: MEDIĊINALI
English: Jorveza 1 mg orodispersible tablets budesonide
Maltese: Jorveza 1 mg pilloli li jinħallu fil-ħalq budesonide
English: − cardiac glycosides such as digoxin (medicines used to treat heart conditions)
Maltese: − glycosides tal-qalb bħal digoxin (mediċini użati biex jikkuraw kondizzjonijiet tal-qalb)
English: However, no systematic study investigating different levels of hepatic impairment is available.
Maltese: Madankollu, m'hemm l-ebda studju sistematiku li jinvestiga livelli differenti ta' indeboliment tal-fwied.
English: Increased risk of infection
Maltese: Riskju miżjud ta' infezzjoni
English: Ketoconazole 200 mg once daily orally increased the plasma concentration of budesonide (3 mg single dose) approximately 6-fold during concomitant administration.
Maltese: Ketoconazole 200 mg darba kuljum meħud mill-ħalq żied il-konċentrazzjoni fil-plażma ta' budesonide (doża waħda ta' 3 mg) b'madwar 6 darbiet meta ngħata fl-istess ħin.
English: Reduced liver function may affect the elimination of budesonide, causing higher systemic exposure.
Maltese: Funzjoni mnaqqsa tal-fwied tista' taffettwa l-eliminazzjoni ta' budesonide, li jikkawża esponiment sistemiku ogħla.
English: Openlabel extension of the treatment with 1 mg budesonide orodispersible tablet twice daily for further 6 weeks in patients without remission in the double-blind phase increased the rate of patients with clinico-pathologic remission to 84.7%.
Maltese: L-estensjoni open-label tal-kura b'1 mg budesonide pillola li tinħall fil-ħalq darbtejn kuljum għal 6 ġimgħat oħra f'pazjenti mingħajr remissjoni fil-fażi double-blind żiedet ir-rata ta' pazjenti b'remissjoni kliniko-patoloġika għal 84.
English: Muscle and joint pain, muscle weakness and twitching, osteoporosis, osteonecrosis
Maltese: Uġigħ fil-muskoli u l-ġogi, dgħufija u kontrazzjonijiet fil muskoli, osteoporożi, osteonekrożi
English: Clearance of budesonide is about 1315 L/hour/kg in healthy subjects and 6.54 ± 4.4 L/hour/kg in EoE patients.
Maltese: It-tneħħija ta' budesonide hija ta' madwar 13 - 15 L/siegħa/kg f'individwi b'saħħithom u 6.54 ± 4.4
English: Upper abdominal pain, gastroesophageal reflux disease, lip edema, nausea, oral paraesthesia
Maltese: Uġigħ fil-parti ta' fuq tal-addome, marda ta' rifluss gastroesofagali, edima fix-xufftejn, dardir, parestesija orali
English: − heartburn
Maltese: Oħrajn
English: NAME OF THE MEDICINAL PRODUCT Jorveza 1 mg orodispersible tablets budesonide
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: The systemic exposure of budesonide is considerably increased in patients with severely impaired hepatic function.
Maltese: L-esponiment sistemiku ta' budesonide jiżdied b'mod konsiderevoli f'pazjenti b'funzjoni tal-fwied indebolita b'mod sever.
English: The glucocorticosteroid activity of the major metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is less than 1% of that of budesonide.
Maltese: L-attività kortikosterojde tal-metaboliti ewlenin, 6β-hydroxybudesonide u 16α-hydroxyprednisolone, hija inqas minn 1% ta' dik ta' budesonide. CYP3A5 ma jikkontribwixxix b'mod sinifikanti għall-metaboliżmu ta' budesonide.
English: The use of this medicine in children younger than 18 years of age has not yet been studied.
Maltese: L-użu ta' din il-mediċina fi tfal iżgħar minn 18-il sena għadu ma ġiex studjat.
English: When patients are subject to surgery or other stresses, supplementary systemic glucocorticosteroid treatment is therefore recommended.
Maltese: Meta l-pazjenti jkunu soġġetti għal kirurġija jew stress ieħor, hija rakkomandata l-kura bi glukokortikosterojdi sistemiċi supplimentari.
English: The total number of infections (including those diagnosed by endoscopy and histology without symptoms) was 33, occurring in 27 out of 87 patients (31%).
Maltese: In-numru totali ta' infezzjonijiet (inklużi dawk iddijanjostikati permezz ta' endoskopija u istoloġija mingħajr sintomi) kien ta' 33, li seħħew f'27
English: Do not take this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Maltese: Tiħux din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara “JIS”.
English: Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see section 4.5).
Maltese: Il-kura fl-istess ħin b'ketoconazole jew b'impedituri oħrajn ta' CYP3A4 għandha tiġi evitata (ara sezzjoni 4.5).
English: − weakening of the bones (osteoporosis)
Maltese: − dgħufija tal-għadam (osteoporożi)
English: Orodispersible tablet
Maltese: Disturbi psikjatriċi
English: If indicated, symptomatic candidiasis of the mouth and throat can be treated with topical or systemic anti-fungal therapy whilst still continuing treatment with Jorveza.
Maltese: Jekk indikat, kandidjażi sintomatika tal-ħalq u l-gerżuma tista' tiġi ttrattata b'terapija topika jew sistemika kontra l-fungi waqt li tkompli bi trattament b'Jorveza.
English: Headache
Maltese: Sentejn
English: It is important that you do not stop taking your medicine without talking to your doctor.
Maltese: Huwa importanti li ma tiqafx tieħu din il-mediċina mingħajr ma tkellem lit-tabib tiegħek.
English: The recommended daily dose is 2 mg budesonide as one 1-mg-tablet in the morning and one in the evening.
Maltese: Id-doża rakkomandata ta' kuljum hija 2 mg budesonide bħala pillola waħda ta' 1 mg filgħodu u waħda filgħaxija.
English: − feeling sick (nausea)
Maltese: - nefħa fix-xufftejn
English: During treatment of patients with hepatic impairment with other budesonide containing products, budesonide levels were increased.
Maltese: Waqt it-trattament ta' pazjenti b'indeboliment tal-fwied bi prodotti oħra li fihom budesonide, il-livelli ta' budesonide żdiedu.
English: In case your kidney problems are severe, you should not take Jorveza.
Maltese: F'każ li l-problemi tal-kliewi tiegħek jkunu severi, m'għandekx tieħu Jorveza.
English: It is used in adults (older than 18 years of age) to treat eosinophilic oesophagitis, which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food.
Maltese: Jintuża fl-adulti (li għandhom aktar minn 18-il sena) biex jikkura esofaġite eżinofilika, li hija kundizzjoni infjammatorja tal-esofagu (kanal tal-ikel) li tikkawża problemi biex tibla' l-ikel.
English: A slightly increased number of basophilic hepatic foci were observed in chronic rat studies with budesonide, and in carcinogenicity studies, an increased incidence of primary hepatocellular neoplasms, astrocytomas (in male rats) and mammary tumours (female rats) were observed.
Maltese: Żieda żgħira fl-għadd ta' foċi tal-fwied basofiliċi ġiet osservata fi studji kroniċi fuq il-firien b'budesonide, u fi studji dwar il-karċinoġeniċità ġiet osservata żieda fl-inċidenza ta' neoplażmi epatoċellulari primarji, astroċitomi (fil-firien irġiel) u tumuri mammarji (fil-firien nisa).
English: Patients with hepatic impairment should not be treated (see sections 4.4 and 5.2).
Maltese: Pazjenti b'indeboliment tal-fwied m'għandhomx jiġu ttrattati (ara sezzjonijiet 4.4 u 5.2).
English: The volume of distribution following administration of 1 mg budesonide to healthy subjects was 35.52 ± 14.94 L/kg and 42.46 ± 23.90 L/kg following administration of 4 mg budesonide to patients with EoE.
Maltese: Il-volum ta' distribuzzjoni wara l-għoti ta' 1 mg budesonide lill-individwi f'saħħithom kien ta' 35.52 ± 14.
English: These side effects depend on the duration of treatment, concomitant and previous glucocorticosteroid treatment and the individual sensitivity.
Maltese: Dawn l-effetti sekondarji jiddependu fuq it-tul tat-trattament, trattament fl-istess waqt u preċedenti ta' glukokortikosterojdi u s-sensittività individwali.
English: Fungal infections in the mouth, pharynx and the oesophagus were the most frequently observed adverse reactions in clinical studies with Jorveza.
Maltese: Infezzjonijiet fungali fil-ħalq, fil-farinġi u fl-esofagu kienu r-reazzjonijiet avversi osservati l-aktar ta' spiss fi studji kliniċi b'Jorveza.
English: Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Jorveza.
Maltese: L-għoti matul it-tqala għandu jiġi evitat sakemm ma jkunx hemm raġunijiet konvinċenti għal terapija b'Jorveza.
English: Name
Maltese: Qawwa
English: Str. Grigore Alexandrescu nr. 59, clădirea HQ Sector 1, 010623, Bucureşti, România
Maltese: Grigore Alexandrescu nr. 59, clădirea HQ Sector 1, 010623, Bucureşti, România
English: Al. Jana Pawła II 29
Maltese: Jana Pawła II 29
English: LT-48100 Kaunas
Maltese: LT-48100
English: Pre-Tx = Pre-treatment; SD = Standard Deviation; SDS = Standard Deviation Score
Maltese: Pre-Tx = Qabel it-trattament; SD = Devjazzjoni Standard; SDS = Punteġġ ta' Devjazzjoni Standard
English: 40mg/4ml
Maltese: INDIVIDWALI 40mg/4ml
English: Lonza AG Lonzastrasse CH-3930 Visp Switzerland
Maltese: Lonza AG Lonzastrasse CH-3930 Visp L-Isvizzera
English: Severe Primary IGFD is defined by:
Maltese: IGFD Primarja severa hija ddefinita bi:
English: Slough, Berkshire SL1 3XE
Maltese: 190 Bath Road Slough, Berkshire SL1 3XE
English: Store in a refrigerator (2C - 8°C).
Maltese: Aħżen fi friġġ (2C - 8°C).
English: Uncommon: Depression, nervousness
Maltese: Mhux komuni: Depressjoni*, nervi
English: INFORMATION IN BRAILLE INCRELEX
Maltese: INFORMAZZJONI BIL-BRAILLE INCRELEX
English: Date of latest renewal: 03 August 2017
Maltese: Data tal-aħħar tiġdid: 03 Awissu 2017
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċepjenti
English: Lietuva, Hrvatska Ipsen Pharma Lietuvos filialas 9-ojo Forto 47
Maltese: Ipsen Pharma Lietuvos filialas 9-ojo Forto 47
English: • height standard deviation score  -3.0 and
Maltese: • skor tad-devjazzjoni standard tat-tul  -3.0 u
English: • GH sufficiency.
Maltese: • suffiċjenza ta' GH
English: Beaufour Ipsen Industrie Rue d'Ethe Virton 28100 Dreux France
Maltese: Beaufour Ipsen Industrie Rue d'Ethe Virton 28100
English: Systemic/local hypersensitivity
Maltese: Sensittività eċċessiva sistemika/lokali
English: Common: Papilloedema
Maltese: Komuni: Papilloedima
English: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, no 16-11o, Miraflores P-1495 - 190 Algés
Maltese: Alameda Fernão Lopes, no 16-11o, Miraflores P-1495 - 190 Algés
English: Glacial acetic acid Sodium acetate Water for injections
Maltese: Glacial acetic acid Sodium acetate Ilma għall-injezzjonijiet
English: Ipsen Pharma Kalnciema iela 33-5 Riga LV 1046
Maltese: Ipsen Pharma Kalnciema iela 33-5 Riga
English: Carbohydrate Metabolism
Maltese: Metaboliżmu tal-Karboidrati
English: The most frequently reported adverse reactions from the clinical trials were headache (44%), hypoglycaemia (28%), vomiting (26%), injection site hypertrophy (17%), and otitis media (17%).
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti mill-provi kliniċi kienu uġigħ ta' ras (44%), ipogliċemija (28%), rimettar (26%), ipertrofija fis-sit tal-injezzjoni (17%), u otitis media.
English: PharmaSwiss d.o.o.
Maltese: PharmaSwiss d.o.o. Brodišče 32
English: Guldensporenpark 87 B-9820 Merelbeke België /Belgique/Belgien Tél/Tel: + 32 9 243 96 00
Maltese: Guldensporenpark 87 B-9820 Merelbeke België /Belgique/Belgien
English: Excipients INCRELEX contains 9 mg/ml benzyl alcohol as a preservative.
Maltese: Eċċipjenti INCRELEX fih 9 mg/ml benzyl alcohol bħala preservattiv.
English: Common: Gynaecomastia
Maltese: Komuni: Ginekomastija
English: 65, quai Georges Gorse 92100 Boulogne-Billancourt France
Maltese: 65, quai Georges Gorse 92100 Boulogne-Billancourt
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 August 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 03 Awissu 2007
English: • basal IGF-1 levels below the 2.5th percentile for age and gender and
Maltese: • livelli ta' GF 1 bażali taħt it-2.5 perċentwali għal età u sess u
English: GR-17456 Αθήνα Ελλάδα
Maltese: GR-17456
English: Brodišče 32 SI-1236 Trzin Tel: + 386 1 236 47 00
Maltese: SI-1236 Trzin Tel: + 386 1 236 47 00
English: Uncommon: Cardiomegaly, ventricular hypertrophy, mitral valve incompetence, tricuspid valve incompetence
Maltese: Kardjomegalija, ipertrofija ventrikulari, inkompetenza tal-valv mitrali, inkompetenza tal-valv trikuspidu
English: Other ingredients: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections.
Maltese: Sustanzi oħra: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate u ilma għall-injezzjonijiet.
English: IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons.
Maltese: IGF-1 jikkonsisti minn 70 aċidu amminiku f'katina waħda bi tlett pontijiet disulfide intramolekolari u piż molekolari ta' 7649 daltons.
English: Tel/Тел.
Maltese: Kaunas Tel.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/402/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/402/001
English: - The other ingredients are: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections (see section 2 "INCRELEX contains benzyl alcohol and sodium").
Maltese: - Sustanzi oħra (eċċipjenti) huma: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate u ilma għall-injezzjonijiet (ara sezzjoni 2 “INCRELEX fih il-benzyl alcohol u s-sodium”).
English: 92100 Boulogne-Billancourt France
Maltese: 92100 Boulogne-Billancourt Franza
English: Clinical Trial
Maltese: Prova Klinika
English: Mecasermin may enlarge your tonsils/adenoids.
Maltese: Mecasermin jista' jneffaħ it-tunsilli/adenojdi tiegħek.
English: Table 1 contains very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000, < 1/100) adverse reactions which occurred in clinical trials.
Maltese: Tabella 1 fiha reazzjonijiet avversi komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) u mhux komuni (≥ 1/1000, < 1/100) li seħħew waqt provi kliniċi.
English: One ml contains 9 mg of benzyl alcohol.
Maltese: Kull ml fih 9 mg ta' benzyl alcohol.
English: This condition is called primary IGF-1 deficiency.
Maltese: Din ilkundizzjoni tissejjaħ defiċjenza ta' IGF-1 primarja.
English: Other uncommon side effects seen with mecasermin treatment include depression, nervousness.
Maltese: Effetti sekondarji mhux komuni oħrajn osservati b'kura b'mecasermin jinkludu depressjoni, nervi.
English: Five clinical studies (4 open-label and 1 double-blind, placebo-controlled) were conducted with INCRELEX.
Maltese: Ħames studji kliniċi (4 open-label u 1 double-blind, ikkontrollat bi plaċebo) kienu magħmula b'INCRELEX.
English: Mecasermin is not a substitute for GH treatment.
Maltese: Mecasermin mhuwiex sostitut għal trattament bil-GH.
English: INCRELEX contains benzyl alcohol and sodium
Maltese: INCRELEX fih il-benzyl alcohol u s-sodium
English: Figure 5: Extract correct dose
Maltese: Estratta d-doża korretta
English: P-value for change from pre-Tx [1]
Maltese: Valur-P għal bidla minn pre-Tx [1]
English: Baseline characteristics for the 81 patients evaluated in the primary and secondary efficacy analyses from the combined studies were (mean ± SD): chronological age (years): 6.8  3.8; age range (years): 1.7 to 17.5; height (cm): 84.1  15.8; height standard deviation score (SDS): -6.9  1.8; height velocity (cm/yr): 2.6  1.7; height velocity SDS: -3.4  1.6; IGF-1 (ng/ml): 24.5  27.9; IGF-1 SDS: -4.2  2.0; and bone age (years): 3.8  2.8.
Maltese: Karatteristiċi fil-linja bażi għall-81 pazjent evalwati fl-analiżi tal-effikaċja primarji u sekondarji mill-istudji kombinati kienu (medja ± SD): età kronoloġika (snin): 6.8  3.8; firxa ta' etajiet (snin): 1.7 sa 17.5; tul (ċm): 84.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists, ATC code: H01AC03
Maltese: Ormoni u analogi pitwitarji u ipotalmiċi, somatropin u agonisti tassomatropin, Kodiċi ATC:
English: Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology.
Maltese: Mecasermin huwa fattur-1 tal-iżvilupp li jixbaħ lill-insulina umana (rhIGF-1) magħmul b'teknoloġija rikombinanti tad-DNA.
English: Adverse reaction data was taken from a total of 413 clinical trial patients with severe Primary IGFD.
Maltese: Dejta dwar reazzjonijiet avversi ttieħdet minn total ta' 413 pazjent mill-provi kliniċi b'IGFD Primarja severa.
English: Ipsen Pharma SAS Magyarországi Kereskedelmi Képviselet Árbóc utca 6.
Maltese: Képviselet Árbóc utca 6.
English: [1] P-values for comparison versus pre-Tx values were computed using paired t-tests.
Maltese: [1] Valuri P għal paragun kontra valuri pre-Tx kienu maħduma permezz ta' testijiet-t pari.
English: Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Maltese: Benzyl alcohol jista' jikkaġuna reazzjonijiet tossiċi u reazzjonijiet anafilattojdifi fi trabi u tfal żgħar sa 3 snin t'età.
English: Height Velocity SDS
Maltese: SDS tal-Veloċità tattul
English: 5 ml vial (type I glass) closed with a stopper (bromobutyl/isoprene polymer) and a seal (lacquered plastic).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett ta' 5 ml (ħġieġ ta' tip I) magħluq b'għatu (bromobutyl/isoprene polymer) u siġill (plastik ivverniċċjat).
English: Mecasermin was administered subcutaneously to Sprague Dawley rats at doses of 0, 0.25, 1, 4, and 10 mg/kg/day for up to 2 years.
Maltese: Mecasermin kien mogħti taħt il-ġilda lill-firien Sprague Dawley f'dożi ta' 0, 0.25, 1, 4, u 10 mg/kg kuljum sa żmien ta' sentejn.
English: Not known: alopecia
Maltese: Mhux magħruf: alopeċja
English: The rhIGF-1 protein is synthesised in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.
Maltese: Il-proteina rhIGF-1 hija sintetizzata fil-batterji (E. coli) li ġew immodifikati biż-żieda tal-ġene għal IGF-1 uman.
English: INCRELEX 10 mg/ml solution for injection Mecasermin
Maltese: INCRELEX 10 mg/ml soluzzjoni għall-injezzjoni mecasermin
English: 140 00 Praha 4 Tel: + 420 242 481 821
Maltese: Tel: + 420 242 481 821
English: Other medicines and INCRELEX
Maltese: Mediċini oħra u INCRELEX
English: *Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.
Maltese: *Mecasermin huwa fattur tal-iżvilupp-1 (IGF-1) li jixbaħ l-insulina umana derivata minn DNA rikombinanti prodott f'Escherichia coli.
English: Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and IGF-1.
Maltese: Liżvilupp u l-metaboliżmu taċ-ċelluli tas-saffi tal-epifisi huma stimulati direttament minn GH u IGF-1.
English: Toxicity to reproduction
Maltese: Tossiċità għar-riproduzzjoni
English: Reactions observed in the clinical trials
Maltese: Reazzjonijiet osservati filprovi kliniċi
English: Mecasermin has no effects on fertility in rats using intravenous doses 0.25, 1, and 4 mg/day (up to 4 times the clinical exposure with the MRHD based on AUC).
Maltese: Mecasermin ma għandux effetti fuq il-fertilità tal-firien li jintużaw fuqhom dożi ġol-vina ta' 0.25, 1, u 4 mg/jum (sa 4 darbiet l-espożizzjoni klinika bl-MRHD ibbażat fuq l-AUC).
English: Clearance of total IGF-1 is inversely proportional to serum IGFBP-3 levels and total IGF-1 systemic clearance (CL/F) is estimated to be 0.04 l/hr/kg at 3 mg/l IGFBP-3 in 12 subjects.
Maltese: Tneħħija ta' IGF-1 totali hija proporzjonalment bil-maqlub ta' livelli ta' IGFBP-3 fis-serum u tneħħija sistemika totali ta' IGF1 (CL/F) hija kkalkulata li hija 0.04 l/hr/kg at 3 mg/l IGFBP-3 fi 12-il suġġett.
English: Common: Melanocytic naevus
Maltese: Komuni: Naevus melanoċitiku
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 10 mg of mecasermin.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ml fih 10 mg ta' mecasermin.
English: • Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.
Maltese: • Esklużjoni ta' forom sekondarji ta' defiċjenza ta' IGF 1, bħal ma' huma nuqqas ta' ikel sustanzjuż, ipotirojdiżmu, jew trattament kroniku b'dożi farmakoloġiċi ta' sterojdi kontra l-infjammazzjoni.
English: An enlarged thymus (a specialized organ of the immune system) has been observed with mecasermin treatment.
Maltese: Timu mkabbar Timu mkabbar (organu speċjalizzat tas-sistema immuni) kien osservat b'kura b'mecasermin.
English: Chemical and physical in-use stability has been demonstrated for 30 days at 2C to 8C.
Maltese: L-istabilità kimika u fiżika waqt l-użu ġiet murija għal 30 jum f'2C sa 8C.
English: Bone/Mineral Metabolism
Maltese: Metaboliżmu tal-Għadam/Minerali
English: Mean (SD) for change from pre-Tx
Maltese: (SD) Medja għal bidla minn pre-Tx
English: • Physician information about INCRELEX (information card, dosing guide, and a dose calculator)
Maltese: • Tagħrif għat-tabib dwar INCRELEX (kard tal-informazzjoni, gwida dwar id-doża, u kalkulatur tad-doża)
English: Injecting the dose:
Maltese: Meta Tinjetta d-doża:
English: Not known: Systemic hypersensitivity (anaphylaxis, generalized urticaria, angioedema, dyspnoea), local allergic reactions at the injection site (pruritus, urticaria)
Maltese: Sensittività eċċessiva sistemika (anafilassi, urtikarja ġeneralizzata, anġjoedima, qtugħ ta' nifs), reazzjonijiet allerġiċi lokali fil-post talinjezzjoni (ħakk, urtikarja)
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Maltese: Studji fuq bhejjem mhumiex biżżejjed rigward it-tossiċità riproduttiva (ara sezzjoni 5.3).
English: How to store INCRELEX 6.
Maltese: Kif taħżen INCRELEX 6.
English: Enlarged tonsils/adenoids
Maltese: Tunsilli/adenojdi minfuħin
English: Table 1: Adverse reactions
Maltese: Tabella 1: Reazzjoijiet Avversi