FrancophonIA/ELRC3.0 huggingface dataset:
English: What Ivabradine Accord contains - The active substance is ivabradine (as hydrochloride).
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Ivabradine Accord - Is-sustanza attiva hi ivabradine (bħala hydrochloride)
English: Excipient with known effect: Each 7.5 mg film-coated tablet contains 108 mg lactose (as anhydrous).
Maltese: Kull pillola miksija b'rita ta' 7.5 mg fiha 108 mg ta' lactose (bħala anhydrous).
English: Ivabradine Accord 5 mg film-coated tablets Ivabradine Accord 7.5 mg film-coated tablets ivabradine
Maltese: Ivabradine Accord 5 mg pilloli miksija b'rita Ivabradine Accord 7.5 mg pilloli miksija b'rita ivabradine
English: 14x1 film-coated tablets
Maltese: 14x1 pilloli miksija b'rita
English: - Hepatic impairment: in patients with mild hepatic impairment (Child Pugh score up to 7) unbound AUC of ivabradine and the main active metabolite were about 20% higher than in subjects with normal hepatic function.
Maltese: - Indeboliment tal-fwied: f'pazjenti b'indeboliment ħafif tal-fwied (Child Pugh sa 7 punti) lAUC ta' ivabradine maħlul u l-prodott attiv tal-metaboliżmu prinċipali kienu madwar 20% ogħla milli f'pazjenti fejn il-fwied kien jaħdem normali.
English: How does Ivabradine Accord work?
Maltese: Kif jaħdem Ivabradine Accord?
English: Bradycardia was reported by 3.3% of patients particularly within the first 2 to 3 months of treatment initiation.
Maltese: Bradikardija ġiet irrapportata minn 3.3% tal-pazjenti l-aktar fl-ewwel 2 sa 3 xhur mill-bidu talkura. 0.5% tal-pazjenti kellhom bradikardija qawwija taħt jew daqs 40 bpm.
English: Ivabradine Accord with food and drink Avoid grapefruit juice during treatment with Ivabradine Accord.
Maltese: Tiħux Ivabradine Accord jekk inti tqila jew qed tippjana li jkollok tarbija (ara taħt “Tiħux Ivabradine Accord”).
English: Severe hepatic insufficiency
Maltese: GĦAMLA KWALITATTIVA
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il- portal elettroniku Ewropew tal-mediċini.
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Ivabradine Accord 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Maltese: F'xi każijiet (eż. jekk inti anzjan), it-tabib tiegħek jista' jordnalek nofs id- doża, jiġifieri nofs pillola ta' 5 mg ta' Ivabradine Accord 5 mg (li tikkorrispondi għal 2.5 mg ta' ivabradine) filgħodu u nofs pillola ta' 5 mg filgħaxija.
English: PK/PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15-20 mg twice daily.
Maltese: Ir-relazzjoni farmakokinetika/farmakodinamika (PK/PD) Analiżi ta' relazzjoni PK/PD wriet li r-rata tat-taħbit tal-qalb tonqos b'mod kważi lineari meta tiżdied il-konċentrazzjoni fil-plażma, ta' ivabradine u ta' S18982 għal dożi sa 15-20 mg darbtejn kuljum.
English: Ivabradine Accord contains lactose
Maltese: Ivabradine Accord fih il-lactose
English: Lack of benefit on clinical outcomes in patients with symptomatic chronic stable angina pectoris
Maltese: Nuqqas ta' benefiċċju mill-eżitu kliniku f'pazjenti b'anġina pectoris sintomatika kronika stabbli
English: What Ivabradine Accord looks like and contents of the pack Ivabradine Accord 5 mg film-coated tablets are salmon-coloured, oblong shaped ,film-coated tablets scored on both sides, debossed with “FK” on one side and “2” on other side.
Maltese: Kif jidher Ivabradine Accord u l-kontenut tal-pakkett Ivabradine Accord 5 mg pilloli miksija b'rita, huma pilloli miksija b'rita, kulur is-salamun, b'forma oblunga, b'sinjal imnaqqax fuq iż-żewġ naħat, imnaqqxin b'“FK” fuq naħa waħda u b'2 fuq in-naħa l-oħra.
English: Sino-atrial block
Maltese: Sindrome tas-sick sinus
English: Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Ivabradine Accord or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy)
Maltese: Kun ċert li tgħarraf lit-tabib tiegħek jekk qed tieħu xi mediċini hawn taħt imsemmija, għax ikun hemm bżonn ta' aġġustar tad-doża ta' Ivabradine Accord jew li titqiegħed taħt osservazzjoni: - fluconazole (mediċina antifungali) - rifampicin (antibijotiku) - barbiturates (għal min ibati biex jorqod jew għall-epilepsija) - phenytoin (għall-epilepsija) - Hypericum perforatum jew St.
English: These data are consistent with the pharmacological effect of ivabradine related to its interaction with hyperpolarisation-activated Ih currents in the retina, which share extensive homology with the cardiac pacemaker If current.
Maltese: Din l- informazzjoni hija konsistenti mal-effett farmakoloġiku ta' ivabradine relatat ma' l-interazzjoni tiegħu ma' iperpolarizzazzjoni-attivata tal-kurrenti Ih fir-retina, li jaqsmu omoloġija estensiva ma' kurrent If tal-pacemaker tal-qalb.
English: Therefore, ivabradine is contraindicated during breast-feeding (see section 4.3).
Maltese: Għalhekk ivabradine huwa kontra- indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: Ivabradine Accord mainly works by reducing the heart rate by a few beats per minute.
Maltese: Ivabradine Accord jaħdem billi jnaqqas ir-rata tat-taħbit tal-qalb bi ftit taħbit fil-minuta.
English: The study showed no difference in the rate of the primary composite outcome in the ivabradine group by comparison to the placebo group (relative risk ivabradine:placebo 1.00, p=0.945).
Maltese: L-istudju ma wera ebda differenza fir-rata tar-riżultat kompost primarju fil- grupp tal-ivabradine meta mqabbel mal-grupp tal-plaċebo (riskju relattiv ivabradine:plaċebo 1.00, p=0.945).
English: interval)
Maltese: Accord
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: AH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Do not take Ivabradine Accord if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Ivabradine Accord”).
Maltese: Tiħux Ivabradine Accord jekk tista' tinqabad tqila ħlief jekk qed tuża miżuri ta' kontraċezzjoni affidabbli (ara “Tiħux Ivabradine Accord”).
English: Ivabradine Accord 7.5 mg film-coated tablets
Maltese: Ivabradine Accord 7.5 mg pilloli miksija b'rita.
English: One film-coated tablet contains 5 mg ivabradine (as hydrochloride) One film-coated tablet contains 7.5 mg ivabradine (as hydrochloride)
Maltese: Pillola waħda miksija b'rita fiha 5 mg ivabradine (ekwivalenti ghal 7.5 mg bħala ivabradine hydrochloride)
English: - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide,
Maltese: John's Wort (kura bil-ħxejjex għad-dipressjoni) - mediċini li jtawwlu l-QT għall-kura ta' problemi fir-ritmu tal-qalb jew kundizzjonijiet oħra bħal: - quinidine, disopyramide, ibutilide, sotalol, amiodarone (għall-kura ta' problemi fir-ritmu tattaħbit tal-qalb) - bepridil (kura għal angina pectoris) - xi mediċini għall-kura ta' ansjetà, skiżofrenija jew psikożi oħra (bħal pimozide, ziprasidone, sertindole) - mediċini kontra l-malarja (bħal mefloquine jew halofantrine) - erythromycin ġol-vini (antibijotiku) - pentamidine (mediċina antiparassitika) - cisapride (għal kontra r-rifluss gastro-esofogali) - xi tipi ta' dijuretiċi li jistgħu jikkawżaw tnaqqis fil-livell tal-potassju, bħal furosemide, hydrochlorothiazide, indapamide (użati għall-kura ta' edema, pressjoni għolja taddemm).
English: Ivabradine Accord 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
Maltese: Pillola waħda miksija b'rita fiha 7.5 mg ivabradine (bħala hydrochloride)
English: Excipient with known effect: Each 5 mg film-coated tablet contains 72 mg lactose (as anhydrous).
Maltese: Kull pillola miksija b'rita ta' 5 mg fiha 72 mg ta' lactose (bħala anhydrous).
English: Ivabradine must not be initiated in patients with a pre-treatment resting heart rate below 70 beats per minute (see section 4.3).
Maltese: Ivabradine m'għandux jinbeda f'pazjenti li qabel il-kura jkollhom rata tat-taħbit tal-qalb waqt ilmistrieħ ta' inqas minn 70 taħbita fil-minuta (ara sezzjoni 4.3).
English: Drug-drug interaction studies have established that CYP3A4 inhibitors increase ivabradine plasma concentrations, while inducers decrease them.
Maltese: Studji fuq interazzjoni bejn mediċini wrew li l- impedituri ta' CYP3A4 iżidu l-konċentrazzjoni tal-plażma ta' ivabradine waqt li l-indutturi jnaqqsuha.
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation: - in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals; - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
Maltese: Ivabradine m'għandux effett fuq il-ħin biex jgħaddi listimulu intrakardijaku, fuq il-kontrazzjoni (l-ebda effett negattiv inotropiku) u lanqas fuq irripolarizzazzjoni ventrikulari: - fi studji kliniċi elettrofiżjoloġiċi, ivabradine la kellu effett fuq il-ħin atrijuventrikulari jew intraventrikulari biex jgħaddi l-istimulu u lanqas fuq l-intervall QT ikkoreġut; - f'pazjenti b'anomilija ventrikulari fuq ix-xellug (frazjoni ventrikulari li toħroġ mix xellug (LVEF) bejn 30 u 45%), ivabradine ma kellu ebda influwenza ta' ħsara fuq
English: Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2)
Maltese: - Imblokk sino-atrijali - Insuffiċjenza tal-qalb instabbli jew akuta - Pazjenti dipendenti fuq pace maker (ir-rata tal-qalb imposta esklussivament mill-pacemaker) - Anġina instabbli - Imblokk AV tat-3 grad - Użu flimkien ma' impedituri taċ-ċitokromu qawwi P450 3A4 bħal mediċini kontra l-fungi tat tip azole (ketoconazole, itraconazole), antibijotiċi tat-tip macrolide (clarithromycin,
English: In the SHIFT trial more patients experienced episodes of increased blood pressure while treated with ivabradine (7.1%) compared to patients treated with placebo (6.1%).
Maltese: Fil-prova SHIFT kien hemm numru akbar ta' pazjenti li esperjenzaw episodji ta' żieda fil-pressjoni tad-demm waqt li kienu qed jingħataw kura b'ivabradine (7.1%) meta mqabbel mal-pazjenti li ngħataw kura bi plaċebo (6.1%).
English: ECG prolonged QT interval
Maltese: Metodu ta' kif għandu jingħata
English: - Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4 inhibitors (e.g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate.
Maltese: L-użu ta' ivabradine flimkien ma' impedituri ta' CYP3A4 moderati (eż.fluconazole) jista' jiġi kkunsidrat b'doża tal-bidu ta' 2.5 mg darbtejn kuljum u jekk ir-rata tat-taħbit tal-qalb mistrieħa hija ogħla minn 70 bpm, hemm bżonn li l-pazjent ikun taħt monitoraġġ minħabba ir-rata tat-taħbit tal-qalb.
English: High exposures to ivabradine that may occur when ivabradine is given in combination with strong CYP3A4 inhibitors may result in an excessive decrease in heart rate although this risk is reduced with moderate CYP3A4 inhibitors (see sections 4.3, 4.4 and 4.5).
Maltese: Bil-maqlub impedituri u mediċini li jġiegħlu iċ- CYP3A4 jaħdem iżjed qawwi jistgħu jaffetwaw sostanzjalment il-konċentrazzjonijiet tal-plażma ta' ivabradine (ara sezzjoni 4.5).
English: Therefore, ivabradine is contraindicated during pregnancy (see section 4.3).
Maltese: Għaldaqstant, ivabradine mhuwiex indikat sabiex jintuża waqt tqala (ara sezzjoni 4.3).
English: * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Maltese: Intervall tal-QT imtawwal tal-ECG * Il-frekwenza hija kkalkolata minn provi kliniċi għal avvenimenti avversi mikxufin minn rapport spontanju
English: Luminous phenomena (phosphenes)
Maltese: Komuni ħafna Fenomeni mudwali (ċrieki ta' dawl) Komuni
English: Osmolarity: 420 - 480 mOsm/L
Maltese: Osmolalità: 420 - 480 mOsm/L
English: Laboratoire Bioluz Zone Industrielle de Jalday 64500 Saint Jean de Luz France
Maltese: Laboratoire Bioluz Zone Industrielle de Jalday 64500 Saint Jean de Luz Franza
English: oxodotreotide.
Maltese: Lu) oxodotreotide.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1381/001
Maltese: EU/1/19/1381/001
English: The frequencies are categorised as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma kategorizzati kif ġej: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-data disponibbli):
English: The recommended dose of LysaKare solution is 1 L (1,000 mL).
Maltese: Id-doża rakkomandata ta' soluzzjoni ta' LysaKare hija 1 L (1,000 mL).
English: How to store LysaKare 6.
Maltese: Kif taħżen LysaKare 6.
English: Due to the intravenous route of administration, LysaKare is 100% bioavailable.
Maltese: Minħabba li jingħata ġol-vini, LysaKare huwa 100% bijodisponibbli.
English: Clear, colourless solution, free from visible particles pH: 5.1 - 6.1
Maltese: Soluzzjoni ċara, mingħajr kulur, ħielsa minn frak viżibbli pH: 5.1 - 6.1
English: Metabolism and nutrition disorders Hyperkalaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Iperkalimja
English: You will receive LysaKare in a controlled clinical setting.
Maltese: Inti se tingħata LysaKare f'ambjent kliniku kontrollat.
English: Like other naturally occurring amino acids, arginine and lysine serve as building blocks in protein anabolism and serve as precursors for several other products, including nitric oxide, urea, creatinine, and Acetyl-Coenzyme A.
Maltese: Bħal aċidi amminiċi li jseħħu b'mod naturali oħrajn, arginine u lysine jservu bħala elementi kostitwenti fl-anaboliżmu tal-proteini u jservu bħala perkursuri għal diversi prodotti oħra, inkluż nitric oxide, urea, kreatinina, u Acetyl-Coenzyme A.
English: Liver function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumin, bilirubin) should be tested before each administration.
Maltese: Il-funzjoni tal-fwied (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumina, bilirubina) għandha tiġi ttestjata qabel kull infużjoni.
English: Care should be taken with LysaKare use in patients with severe hepatic impairment and in case of either total bilirubinemia >3 times the upper limit of normal or albuminemia <30 g/L and prothrombin ratio <70% during treatment.
Maltese: Għandha tingħata attenzjoni meta jsir użu ta' LysaKare f'pazjenti b'indeboliment sever tal-fwied u filkaż ta' bilirubinemija totali >3 darbiet il-limitu ta' fuq tan-normal jew albuminemija <30 g/L u proporzjon ta' prothrombin <70% matul it-trattament.
English: LysaKare contains the active substances arginine and lysine, two different amino acids.
Maltese: LysaKare fih is-sustanzi attivi arginine u lysine, żewġ aċidi amminiċi differenti.
English: 1,000 mL
Maltese: <30 mL/min.
English: Solution for infusion (infusion).
Maltese: Soluzzjoni għall-infużjoni (infużjoni).
English: The infusion of LysaKare will start 30 minutes before you are given Lutathera, and will last over a 4 hour period.
Maltese: L-infużjoni ta' LysaKare se tibda 30 minuta qabel ma tingħata Lutathera, u se ddum għal 4 sigħat.
English: Metabolic acidosis has been observed with complex amino-acid solutions administered as part of total parenteral nutrition (TPN) protocols.
Maltese: Aċidożi metabolika kienet osservata b'soluzzjonijiet ta' aċidi amminiċi kumplessi mogħtija bħala parti minn protokolli ta' nutrizzjoni parenterali totali (TPN, total parenteral nutrition).
English: LysaKare is given as an infusion (drip) into a vein.
Maltese: LysaKare tingħata bħala infużjoni (drip) ġol-vina.
English: Infusion bag made of polyvinyl chloride (PVC) containing 1,000 mL of solution, wrapped in a polyethylene polyamine/aluminium foil.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Borża tal-infużjoni tal-polyvinyl chloride (PVC) li fiha 1,000 mL ta' soluzzjoni, mgeżwra f'polyethylene polyamine/fojl tal-aluminju.
English: Gastrointestinal disorders Nausea
Maltese: Disturbi gastro-intestinali Nawsja
English: There are no data on the effects of arginine and lysine on fertility.
Maltese: M'hemmx data dwar l-effetti ta' arginine u lysine fuq il-fertilità.
English: Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 mL/min.
Maltese: Għandha tingħata attenzjoni bl-użu ta' LysaKare f'pazjenti bi tneħħija tal-kreatinina bejn 30 u 50 mL/min.
English: Pharmacotherapeutic group: All other therapeutic products, detoxifying agents for antineoplastic treatment, ATC code: V03AF11
Maltese: Il-prodotti terapewtiċi l-oħra kollha, aġenti diżintossifikanti għal trattament antineoplastiku, Kodiċi ATC:
English: The main adverse reactions which are related mainly to the amino acid solution are nausea (approximately 25%), vomiting (approximately 10%) and hyperkalaemia.
Maltese: Ir-reazzjonijiet avversi ewlenin li huma relatati l-aktar mas-soluzzjoni ta' aċidi amminiċi huma nawsja (madwar 25%), rimettar (madwar 10%) u iperkalimja.
English: Vascular disorders Flushing
Maltese: Disturbi vaskulari Fwawar
English: The patient should be monitored closely for signs and symptoms of hyperkalaemia, e.g. dyspnoea, weakness, numbness, chest pain and cardiac manifestations (conduction abnormalities and cardiac arrhythmias).
Maltese: Il-pazjent għandu jiġi mmonitorjat mill-qrib għal sinjali u sintomi ta' iperkalimja, pereżempju qtugħ ta' nifs, dgħjufija, tirżiħ, uġigħ fis-sider u manifestazzjonijiet kardijaċi (anormalitajiet fit-trażmissjoni u arritmiji kardijaċi).
English: • high potassium levels seen in blood tests, abdominal (belly) pain, headache, dizziness and flushing.
Maltese: • livelli għoljin ta' potassju fit-testijiet tad-demm, uġigħ (ta' żaqq) addominali, uġigħ ta' ras,
English: The adverse reactions listed below have been identified in publications of studies with amino acid solutions with the same composition with regards to the amino acid content, involving over 900 patients receiving more than 2,500 doses of arginine and lysine during PRRT with various radiolabelled somatostatin analogues.
Maltese: Ir-reazzjonijiet avversi mniżżla hawn taħt ġew identifikati f'pubblikazzjonijiet ta' studji b'soluzzjonijiet ta' aċidi amminiċi bl-istess kompożizzjoni fir-rigward tal-kontenut ta' aċidi amminiċi, li kienu jinvolvu iktar minn 900 pazjent li nagħtaw iktar minn 2,500 doża ta' arginine u lysine matul PRRT b'analogi ta' somatostatin radjutikkettati differenti.
English: How to store LysaKare
Maltese: X'inhu LysaKare
English: NAME OF THE MEDICINAL PRODUCT LysaKare 25 g/25 g solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI LysaKare 25 g/25 g soluzzjoni għall-infużjoni
English: Arginine and lysine are rapidly distributed.
Maltese: Arginine u lysine jiġu distribwiti malajr.
English: LysaKare should be administered as a 4-hour infusion (250 mL/hour) starting 30 minutes prior to administration of lutetium (177Lu) oxodotreotide to achieve optimal renal protection.
Maltese: LysaKare għandu jingħata bħala infużjoni li ddum 4 sigħat (250 mL/siegħa) li tibda 30 minuta qabel lgħoti ta' lutetium (
English: Treatment with lutetium (177Lu) oxodotreotide is not recommended for patients with renal function between 30 and 50 mL/min therefore, the benefit risk for these patients will always need to be weighed carefully, which should include consideration of an increased risk for transient hyperkalaemia in these patients (see section 4.4).
Maltese: It-trattament b'lutetium (177Lu) oxodotreotide mhux rakkomandat għal pazjenti b'funzjoni tal-kliewi bejn 30 u 50 mL/min, għalhekk il-benefiċċji u r-riskji għal dawn il-pazjenti għandhom dejjem jiġu kkunsidrati b'attenzjoni, li jinkludi kunsiderazzjoni tar-riskju miżjud għal iperkalimja temporanja f'dawn il-pazjenti (ara sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT LysaKare 25 g/25 g solution for infusion L-arginine hydrochloride/L-lysine hydrochloride
Maltese: Informazzjoni għall-pazjent LysaKare 25 g/25 g soluzzjoni għall-infużjoni L-arginine hydrochloride/ L-lysine hydrochloride
English: A dosimetry study including 6 patients showed that a 2.5% Lysine-Arginine amino acid solution reduced renal radiation exposure by about 47% as compared to no treatment, without having an effect on tumour uptake of lutetium (177Lu) oxodotreotide.
Maltese: Studju tad-dożimetrija li kien jinkludi 6 pazjenti wera li soluzzjoni ta' 2.5% tal-aċidi amminiċi LysineArginine naqset l-esponiment tal-kliewi għar-radjazzjoni b'madwar 47% kif imqabbla ma' ebda trattament, mingħajr kwalunkwe effett fuq l-assorbiment mit-tumur ta' lutetium (
English: Marketing Authorisation Holder Advanced Accelerator Applications 20 rue Diesel
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Advanced Accelerator Applications 20 rue Diesel
English: Based on a study with 30 g arginine infused over 30 minutes, plasma elimination of amino acids follows at least a biphasic or triphasic decline, with levels returning to baseline within 6 hours post-dose.
Maltese: Fuq il-bażi ta' studju b'30 g arginine infużi għal 30 minuta, leliminazzjoni fil-plażma ta' aċidi amminiċi ssegwi mill-inqas tnaqqis bifażiku jew trifażiku, b'livelli li jirritornaw għal-linja bażi fi żmien 6 sigħat wara d-doża.
English: Initial rapid clearance is through glomerular filtration in the kidney in the first 90 minutes post-infusion.
Maltese: It-tneħħija rapida inizjali hija permezz talfiltrazzjoni glomerulari fil-kliewi fl-ewwel 90 minuta wara l-infużjoni.
English: What you need to know before you take LysaKare 3.
Maltese: X'għandek tkun taf qabel ma tieħu LysaKare 3.
English: What LysaKare is
Maltese: U LUŻU
English: Clinical efficacy and safety for arginine and lysine are based on published literature of studies using solutions with the same arginine and lysine content as LysaKare.
Maltese: L-effikaċja klinika u s-sigurtà ta' arginine u lysine huma bbażati fuq letteratura ppubblikata ta' studji li jużaw soluzzjonijiet bl-istess kontenut ta' arginine u lysine bħal LysaKare.
English: What LysaKare contains - The active substances are arginine and lysine.
Maltese: X'fih LysaKare - Is-sustanzi attivi huma arginine u lysine.
English: Each infusion bag contains 1 L LysaKare of solution.
Maltese: Kull borża tal-infużjoni fiha 1 L ta' soluzzjoni ta' LysaKare.