FrancophonIA/ELRC3.0 huggingface dataset:
English: For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Tybost.
Maltese: Għat-trattament ta' disfunzjoni erettili, hu rakkomandat li doża waħda ta' sildenafil ta' mhux aktar minn 25 mg fi 48 siegħa, vardenafil mhux aktar minn 2.5 mg fi 72 siegħa, jew tadalafil mhux aktar minn 10 mg fi 72 siegħa, jingħataw flimkien ma'
English: AUC: ↑ 130% Cmax: ↔
Maltese: AUC: ↑ 130% Cmax: ↔ Cmin: NC
English: ANTICONVULSANTS Carbamazepine (200 mg twice daily)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Maltese: MEDIĊINI KONTRA L-KONVULŻJONIJIET Carbamazepine (200 mg darbtejn kuljum)/Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: Cobicistat exposures are non-linear and greater than dose-proportional over the range of 50 mg to 400 mg, consistent with a mechanism-based CYP3A inhibitor.
Maltese: Esponimenti ta' cobicistat mhumiex lineari u huma akbar minn proporzjonali għad-doża fuq il-medda ta' 50 mg sa 400 mg, konsistenti ma' impeditur ta' CYP3A ibbażat kif jagħmel l-effett tiegħu.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of cobicistat/metabolites in milk.
Maltese: Dejta farmakodinamika / tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' cobicistat/metaboliti fil-ħalib tas-sider.
English: For further details, consult the Summary of Product Characteristics for maraviroc.
Maltese: Għal aktar dettalji, ikkonsulta s-Sommarju talKaratteristiċi tal-Prodott għal maraviroc.
English: Alternative or additional contraceptive measures are recommended when oestrogen-based contraceptives are co-administered with darunavir/cobicistat.
Maltese: Miżuri kontraċettivi alternattivi jew addizzjonali huma rakkomandati meta kontraċettivi bbażati fuq oestrogen jingħataw flimkien ma' darunavir/cobicistat.
English: The rates of study drug discontinuation due to bilirubin-related adverse events were low and similar in both groups (4.9% in the cobicistat-boosted group and 4.0% in the ritonavir-boosted group).
Maltese: Ir-rati ta' twaqqif tal-mediċina tal-istudju minħabba avvenimenti avversi relatati mal-bilirubina kienu baxxi u simili fiżżewġ gruppi (4.9% fil-grupp imsaħħaħ minn cobicistat u 4.0% fil-grupp imsaħħaħ minn ritonavir).
English: AUC: ↑ 58% Cmax: ↔
Maltese: AUC: ↑ 58% Cmax: ↔ Cmin: NC
English: Missing data during window but on study drug a Week 48 window is between day 309 and 378 (inclusive) b Week 144 window is between day 967 and 1,050 (inclusive) c Includes subjects who had ≥ 50 copies/ml in the week 48 or 144 windows; subjects who discontinued early due to lack or loss of efficacy; subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy, and at the time of discontinuation had a viral value of ≥ 50 copies/ml.
Maltese: ċ Jinkludi individwi li kellhom ≥ 50 kopja/mL fl-intervalli ta' żmien f'ġimgħa 48 jew 144; individwi li waqfu kmieni minħabba nuqqas jew telf ta' effikaċja; individwi li waqfu għal raġunijiet li m'humiex avveniment avvers; mewt jew nuqqas jew telf ta' effikaċja; u li meta waqfu kellhom valur virali ta' ≥ 50 kopja/mL. d Jinkludi pazjenti li waqfu minħabba avveniment avvers (AE) jew mewt fi kwalunkwe ħin minn jum 1 sal intervall ta' żmien jekk dan irriżulta fl-ebda dejta viroloġika fuq it-trattament matul l-intervall ta' żmien speċifikat.
English: Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Maltese: Maraviroc hu substrat ta' CYP3A u l-konċentrazzjoni tiegħu filplażma tiżdied meta jingħata flimkien ma' impedituri qawwija ta' CYP3A.
English: • apixaban, edoxaban, rivaroxaban and warfarin, medicines used to prevent and treat blood clots
Maltese: • apixaban, edoxaban, rivaroxaban u warfarin, mediċini li jintużaw għall-prevenzjoni u ttrattament ta' emboli tad-demm
English: EXP
Maltese: P-gp.
English: When co-administration is necessary, do not exceed 10 mg rosuvastatin daily and clinical monitoring for safety (e.g. myopathy) is recommended.
Maltese: Meta l-għoti flimkien ikun neċessarju, taqbiżx l-10 mg ta' rosuvastatin kuljum u monitoraġġ kliniku għas-sigurtà (eż. mijopatija) hu rakkomandat.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Maltese: L-ebda differenzi farmakokinetiċi klinikament rilevanti minħabba s-sess ma ġew identifikati għal cobicistat.
English: Plasma concentrations of drospirenone are increased following co-administration of drospirenone/ethinyloestradiol with darunavir/cobicistat.
Maltese: Il-konċentrazzjonijiet ta' drospirenone filplażma jiżdiedu wara l-għoti ta' drospirenone/ethinyloestradiol flimkien ma' darunavir/cobicistat.
English: Rosuvastatin (10 mg single dose)/Darunavir (800 mg once daily)/Cobicistat (150 mg once daily)
Maltese: Rosuvastatin (10 mg doża waħda)/Darunavir (800 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: • high sugar levels in the blood (hyperglycaemia)
Maltese: • livelli għoljin ta' zokkor fid-demm (ipergliċemija)
English: Concomitant use contraindicated
Maltese: Rekwiżiti ta' kontraċezzjoni
English: Changes in CD4+ cell counts through 48 and 144 weeks in Study GS-US-216-0114 are presented in Table 8.
Maltese: Il-bidliet fl-għadd taċ-ċelluli CD4+ sat-48 u l-144 ġimgħa fl-Istudju GS-US-216-0114 huma ppreżentati fit-Tabella 8.
English: Table 7: Virologic outcome of randomised treatment of Study GS-US-216-0114 at weeks 48 and Week 48a
Maltese: GS-US-216-0114 f'ġimgħat 48 u 144
English: Darunavir/ritonavir may be considered as an alternative.
Maltese: Darunavir/ritonavir jista' jiġi kkunsidrat bħala alternattiva.
English: Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Maltese: Cobicistat huwa impeditur selettiv, ibbażat fuq kif jagħmel l-effett tiegħu, ta' ċitokromi P450 tassottofamilja ta' CYP3A.
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 fissezzjoni 6.1.
English: Co-administration of Tybost with sildenafil for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Tybost ma' sildenafil għat-trattament ta' pressjoni għolja arterjali pulmonari hu kontraindikat (ara sezzjoni 4.3).
English: Rosuvastatin (10 mg single dose)/Atazanavir (300 mg once daily)/Cobicistat (150 mg once daily)
Maltese: Rosuvastatin (10 mg doża waħda)/Atazanavir (300 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: Tybost should not be initiated in patients with creatinine clearance less than 70 ml/min if one or more co-administered agent requires dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir).
Maltese: Tybost m'għandux jinbeda f'pazjenti bi tneħħija tal-krejatinina inqas minn 70 mL/min jekk mediċina waħda jew aktar mogħtija fl-istess ħin ikunu jeħtieġu aġġustament fid-doża bbażat fuq it-tneħħija talkrejatinina (eż. emtricitabine, lamivudine, tenofovir disoproxil jew adefovir).
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at mean concentrations at least 10-fold higher than the human exposure at the recommended 150 mg daily dose.
Maltese: Studji ex vivo fil-fniek u studji in vivo fil-klieb jissuġġerixxu li cobicistat għandu potenzjal baxx għattitwil tal-QT, u jista' jtawwal bi ftit l-intervall tal-PR u jnaqqas il-funzjoni ventrikulari fuq in-naħa taxxellug f'konċentrazzjonijiet medji li kienu mill-inqas 10 darbiet ogħla mill-esponiment fil-bniedem fid-doża rakkomandata ta' kuljum ta' 150 mg.
English: The pharmacokinetic enhancing effect of cobicistat on darunavir was evaluated in a phase 1 clinical Study GS-US-216-0115 in 31 healthy subjects that were administered darunavir 800 mg in combination with cobicistat 150 mg or ritonavir 100 mg, all once daily, for 10 days.
Maltese: GS-US-216-0115 f'31 individwi b'saħħithom li ngħataw darunavir 800 mg flimkien ma' cobicistat 150 mg jew ritonavir 100 mg, kollha darba kuljum, għal għaxart ijiem.
English: Among the 19 patients, 1 developed the emtricitabine-associated resistance substitution M184V with no tenofovir- or primary protease inhibitor-associated resistance substitutions.
Maltese: Fost id-19-il pazjent, 1 żviluppa ssostituzzjoni ta' reżistenza M184V assoċjata ma' emtricitabine bl-ebda sostituzzjonijiet ta' reżistenza assoċjati ma' tenofovir jew kwalunkwe sostituzzjoni ta' reżistenza primarja assoċjata ma' inibituri talproteases.
English: hyperbilirubinaemia Skin and subcutaneous tissue disorders: Common:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi:
English: Co-administration of Tybost with medicinal products that are substrates of these transporters can result in increased plasma concentrations of the co-administered medicinal products (see section 4.4).
Maltese: L-għoti flimkien ta' Tybost ma' prodotti mediċinali li huma substrati ta' dawn it-trasportaturi jista' jirriżulta f'żieda talkonċentrazzjonijiet fil-plażma tal-prodotti mediċinali mogħtija flimkien (ara sezzjoni 4.4)
English: Contents of the pack and other information What Tybost contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Tybost
English: Co-administration of tenofovir disoproxil with cobicistat is expected to increase tenofovir plasma concentration.
Maltese: L-għoti flimkien ta' tenofovir disoproxil ma' cobicistat hu mistenni li jżid il-konċentrazzjoni ta' tenofovir fil-plażma.
English: If drospirenone/ethinyloestradiol is co-administered with atazanavir/cobicistat or darunavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Maltese: Jekk drospirenone/ethinyloestradiol jingħata flimkien ma' atazanavir/cobicistat jew darunavir/cobicistat huwa rakkomandat monitoraġġ kliniku minħabba l-potenzjal għal iperkalemja.
English: Co-administration of cobicistat with medicinal products that inhibit CYP3A may decrease the clearance of cobicistat, resulting in increased cobicistat plasma concentrations (see section 4.5).
Maltese: L-għoti ta' cobicistat flimkien ma' prodotti mediċinali li jinibixxu CYP3A jista' jnaqqas it-tneħħija ta' cobicistat, li jirriżulta f'żieda tal-konċentrazzjonijiet fil-plażma ta' cobicistat (ara sezzjoni 4.5).
English: The safety of cobicistat is based on 144-week data from a phase 3, randomised, active-controlled clinical Study (GS-US-216-0114), in which 692 treatment-naïve patients received at least one dose of cobicistat-boosted atazanavir (n = 344) or ritonavir-boosted atazanavir (n = 348) administered with emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Maltese: Is-sigurtà ta' cobicistat hija bbażata fuq dejta fuq 144 ġimgħa mill-Istudju kliniku ta' fażi 3 (GS-US-216-0114), li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat b'mod attiv, li fih 692 pazjent li qatt ma rċivew kura fil-passat irċivew mill-inqas doża waħda ta' atazanavir imsaħħaħ minn cobicistat (n = 344) jew atazanavir imsaħħaħ minn ritonavir (n = 348) mogħtija ma' kombinazzjoni ta' doża fissa ta' emtricitabine u tenofovir disoproxil fumarate.
English: Co-administration of cobicistat with medicinal products that induce CYP3A is contraindicated or is not recommended (see sections 4.3 and 4.5) because decreased plasma concentrations of cobicistat could result in plasma levels that are insufficient to achieve adequate pharmacoenhancement of atazanavir or darunavir.
Maltese: L-għoti ta' cobicistat flimkien ma' prodotti mediċinali li jinduċu CYP3A hu kontraindikat jew mhuwiex rakkomandat (ara sezzjonijiet 4.3 u 4.5) għax tnaqqis tal-konċentrazzjoni fil-plażma ta' cobicistat jista' jirriżulta f'livelli fil-plażma li jkunu insuffiċjenti biex jiksbu titjib farmakokinetiku adegwat ta' atazanavir jew darunavir.
English: • increased levels of bilirubin in the blood (hyperbilirubinaemia)
Maltese: • żieda fil-livelli ta' bilirubina fid-demm (iperbilirubinimja)
English: When co-administering maraviroc and Tybost patients should receive maraviroc 150 mg twice daily.
Maltese: Meta maraviroc u Tybost jingħataw flimkien, il-pazjenti għandhom jirċievu maraviroc 150 mg darbtejn kuljum.
English: Concomitant use of cobicistat and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Maltese: L-użu fl-istess ħin ta' cobicistat u kortikosterojdi li huma metabolizzati minn CYP3A eż. fluticasone propionate jew kortikosterojdi oħra li jinġibdu man-nifs jew nażali jista' jżid ir-riskju tal-iżvilupp ta' effetti sistemiċi tal-kortikosterojdi, inkluż is-sindrome ta' Cushing u ssuppressjoni adrenali.
English: Tybost [Outer packaging only]
Maltese: INFORMAZZJONI BIL-BRAILLE Tybost [Pakkett ta' barra biss]
English: ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
Maltese: TAR-RIĊETTURI TA' ENDOTHELIN Bosentan
English: St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety lovastatin, simvastatin, used to lower blood cholesterol pimozide, lurasidone, used to treat abnormal thoughts or feelings sildenafil, used to treat pulmonary arterial hypertension - a lung disease that makes breathing difficult orally administered midazolam, triazolam, used to help you sleep and/or relieve anxiety
Maltese: John's wort (Hypericum perforatum), rimedju li ġej mill-ħxejjex li jintuża għaddipressjoni u l-ansjetà lovastatin, simvastatin, jintużaw biex ibaxxu l-kolesterol fid-demm pimozide, lurasidone, jintużaw għal trattament ta' ħsibijiet jew sensazzjonijiet mhux normali sildenafil, jintuża għal trattament ta' pressjoni arterjali pulmonari għolja - marda talpulmun li tagħmilha diffiċli biex tieħu n-nifs midazolam li jingħata mill-ħalq, triazolam, jintużaw biex jgħinuk torqod u/jew biex itaffu l-ansjetà
English: Co-administration of salmeterol and Tybost is not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' salmeterol u Tybost mhuwiex rakkomandat (ara sezzjoni 4.4).
English: NC = not calculated
Maltese: NC = mhux ikkalkulat
English: The doses of Tybost and the co-administered protease inhibitor, atazanavir or darunavir, are presented in Table 1.
Maltese: Id-dożi ta' Tybost u l-inibitur tal-protease mogħtija flimkien, atazanavir jew darunavir huma ppreżentati f'Tabella 1.
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and is a CYP3A substrate.
Maltese: Cobicistat hu impeditur qawwi ta' CYP3A ibbażat fuq kif jagħmel l-effett tiegħu u hu substrat ta' CYP3A.
English: • headache, dizziness
Maltese: • uġigħ ta' ras, sturdament
English: headache, dizziness, somnolence, dysgeusia
Maltese: (dispepsija) tħossok minfuħ, gass
English: • ritonavir • cobicistat
Maltese: • cobicistat
English: Table 1: Dosing regimens Dose of Tybost
Maltese: Mediċini oħra u Tybost
English: f Plus background regimen of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg fixed-dose combination
Maltese: f Flimkien ma' kors fl-isfond ta' kombinazzjoni ta' doża fissa ta' emtricitabine 200 mg u tenofovir disoproxil fumarate 300 mg
English: Pharmacokinetics of cobicistat have not been fully evaluated in the elderly (65 years of age and older).
Maltese: Il-farmakokinetika ta' cobicistat ma ġietx evalwata b'mod sħiħ fl-anzjani (li kellhom 65 sena u aktar).
English: ocular icterus Gastrointestinal disorders: Very common:
Maltese: Disturbi gastro-intestinali:
English: Atazanavir + ritonavirf (n = 348)
Maltese: Atazanavir + ritonavirf
English: • maraviroc
Maltese: • ritonavir
English: There are limited data from the use of cobicistat and atazanavir in pregnant women.
Maltese: Hemm dejta limitata dwar l-użu ta' cobicistat u atazanavir f'nisa tqal.
English: If drospirenone/ethinyloestradiol is co-administered with atazanavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Maltese: Jekk drospirenone/ethinyloestradiol jingħata flimkien ma' atazanavir/cobicistat hu rakkomandat monitoraġġ kliniku minħabba l-potenzjal għal iperkalemja.
English: Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/Atazanavir (300 mg once daily)/Cobicistat (150 mg once daily)
Maltese: 02 mg doża waħda)/Atazanavir (300 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: Viruses were known to be susceptible to atazanavir, emtricitabine and tenofovir disoproxil fumarate at baseline.
Maltese: Il-vajrusijiet kienu magħrufa li huma suxxettibbli għal atazanavir, emtricitabine u tenofovir disoproxil fumarate fil-linja bażi.
English: hyperglycaemia, increased appetite Psychiatric disorders:
Maltese: Disturbi fil-kliewi u fis-sistema urinarja:
English: • blood in the urine (haematuria)
Maltese: • demm fl-awrina (ematurija)
English: When administering ketoconazole with Tybost, the maximum daily dose of ketoconazole should not exceed 200 mg per day.
Maltese: Meta ketoconazole jingħata ma' Tybost, iddoża massima ta' kuljum ta' ketoconazole m'għandhiex taqbeż 200 mg kuljum.
English: Consult the Summary of Product Characteristics of atazanavir or darunavir for further information on use in combination with these medicinal products.
Maltese: Ikkonsulta s-Sommarju tal-Karatteristiċi tal-Prodott ta' atazanavir jew darunavir għal informazzjoni addizzjonali dwar l-użu flimkien ma' dawn il-prodotti mediċinali.
English: An increase from baseline in serum creatinine solely due to cobicistat's inhibitory effect generally does not exceed 0.4 mg/dl.
Maltese: Żieda tal-krejatinina fis-serum mil-linja bażi biss minħabba l-effett inibitorju ta' cobicistat ġeneralment ma taqbiżx 0.4 mg/dL.
English: DOAC = direct oral anticoagulant 1 Study was conducted with tenofovir disoproxil fumarate
Maltese: DOAC = mediċina kontra t-tagħqid tad-demm diretta li tingħata mill-ħalq 1 L-istudju twettaq b'tenofovir disoproxil fumarate
English: Cobicistat is 97-98% bound to human plasma proteins and the mean plasma to blood drug concentration ratio was 2.
Maltese: Cobicistat jeħel b'rata ta' 97-98% mal-proteini tal-plażma tal-bniedem u l-medja tal-proporzjon tal-konċentrazzjoni tal-mediċina fil-plażma mqabbla ma' dik fid-demm kienet ta' 2.
English: ORAL CONTRACEPTIVES Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/ Darunavir (800 mg once daily)/Cobicistat (150 mg once daily)
Maltese: 02 mg doża waħda)/ Darunavir (800 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: nausea
Maltese: Dabigatran
English: GLUCOCORTICOIDS
Maltese: Ketoconazole
English: It is recommended that the international normalised ratio (INR) be monitored upon co-administration with Tybost.
Maltese: Hu rakkomandat li l-proporzjon normalizzat internazzjonali (INR) jiġi mmonitorjat meta jingħata flimkien ma'
English: Co-administration with cobicistat may result in increased sildenafil, tadalafil and vardenafil plasma concentrations, which may result in PDE-5 inhibitorassociated adverse reactions.
Maltese: L-għoti flimkien ma' cobicistat jista' jirriżulta f'żieda tal-konċentrazzjonijiet ta' sildenafil, tadalafil u vardenafil fil-plażma, li jista' jirriżulta f'reazzjonijiet avversi assoċjati ma' impeditur ta' PDE-5.
English: Gilead Sciences Ireland UC Tel.: + 353 (0) 1 686 1888
Maltese: Tel: + 353 (0) 1 686 1888
English: • Caution must be demonstrated if the patient: - has severe liver function impairment - has chronic liver diseases known to represent preneoplastic conditions (e.g. advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects) - is receiving a concomitant therapy including hepatotoxic and/or genotoxic properties - is receiving concomitant therapy with amphotericin B desoxycholate - has history of haemolysis, haemolytic anaemia or renal impairment.
Maltese: - għandu mard tal-fwied kroniku li hu magħruf li jirrapreżenta kundizzjonijiet preneoplastiċi (eż. fibrosi tal-fwied avvanzata, ċirrosi, epatite virali, mard tal-fwied fit-tarbija li għada titwieled jew difett f'enzimi konġenitali) - qed jirċievi xi terapija konkomitanti li tinkludi karatteristiċi epatotossiċi u/jew ġenotossiċi
English: • Mycamine is contra-indicated if the patient has a history of hypersensitivity to micafungin, other echinocandins or excipients.
Maltese: • Mycamine huwa kontra-indikat jekk il-pazjent ikollu storja ta' sensittività eċċessiva għal micafungin, għal echinocandins oħra jew xi sustanza mhux attiva.
English: • Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary.
Maltese: • Pazjenti li qed jirċievu sirolimus, nifedipine jew itraconazole flimkien ma' Mycamine għandhom jiġu monitorati għat-tossiċità ta' sirolimus, nifedipine jew itraconazole u d-doża ta'
English: ANNEX 127a CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Maltese: ANNESS 127a KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TA' L-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI
English: • To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended.
Maltese: formazzjoni ta' tumur fil-fwied, it-twaqqif bikri minħabba preżenza sinifikanti u persistenti għolja ta' ALT/AST hi rakkomandata.
English: Somatropin is a recombinant human growth hormone (rhGH) acting on the metabolism of lipids, carbohydrates and proteins.
Maltese: Somatropin huwa ormon tat-tkabbir uman rikombinanti (rhGH) li jaġixxi fuq il-metaboliżmu tal-lipidi, karboidrati u proteini.
English: This information was circulated in a rapid alert triggering a procedure under Article 107 of Directive 2001/83/EC, as amended.
Maltese: Din l-informazzjoni ġiet iċċirkolata fl-azzjonar ta' twissija rapida ta' proċedura skont l-Artikolu 107 tadDirettiva 2001/83/KE, kif emendata.
English: Currently there are nine approved somatropin-medicinal products in the Union: Genotropin, Humatrope, Maxomat, Norditropin, Saizen, Zomacton approved via Mutual Recognition procedure (MRP) or Nationally (NAP) and Omnitrope, NutropinAq and Valtropin approved centrally (CAP).
Maltese: Fil-preżent, hemm disa' prodotti mediċinali b'somatropin approvati fl-Unjoni: Genotropin, Humatrope, Maxomat, Norditropin, Saizen, Zomacton approvati permezz ta' proċedura ta' Rikonoxximent Reċiproku (MRP) jew fuq livell Nazzjonali (NAP) u Omnitrope, NutropinAq u Valtropin approvati ċentralment (CAP).
English: 3 Ergun Longmire B, Mertens AC, Mitby P, Qin J, Heller G, Shi W et al. Growth hormone treated and risk of second malignant neoplasms in the childhood cancer survivor.
Maltese: 3 Ergun Longmire B, Mertens AC, Mitby P, Qin J, Heller G, Shi W et al.
English: 1 Swerdlow AJ, Higgins CD, Adlard P, et al. Risk of cancer in patients treated with pituitary growth hormone in the UK, 195985: a cohort study.
Maltese: Risk of cancer in patients treated with pituitary growth hormone in the UK, 1959-85: a cohort study.
English: The low risk population defined as treatment for idiopathic growth hormone deficiency, idiopathic short stature, short stature in children born short for gestational age, or isolated growth hormone deficiency was included in the mortality analysis (n=6,892 patients corresponding to 116,403 person-years of observation).
Maltese: Il-popolazzjoni b'riskju baxx definita bħala kura għal nuqqas ta' ormon tat-tkabbir idjopatiku, statura qasira idjopatika, statura qasira fi tfal imwielda qosra għall-età ġestazzjonali, jew nuqqas ta' ormon tat-tkabbir iżolat ġiet inkluża fl-analiżi tal-mortalità (n=6,892 pazjenti li jikkorrespondu għal 116,403 persuni-snin ta' osservazzjoni).