FrancophonIA/ELRC3.0 huggingface dataset:
English: If Emtricitabine/Tenofovir disoproxil Krka is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule - That patients should have their baseline renal function assessed prior to initiating Emtricitabine/Tenofovir disoproxil Krka therapy - The importance of regular monitoring of renal function during Emtricitabine/Tenofovir disoproxil Krka therapy - Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment - Instructions on the use of the creatinine clearance slide ruler
Maltese: Jekk Emtricitabine/Tenofovir disoproxil Krka jintuża ma' prodotti mediċinali nefrotossiċi, il-funzjoni tal-kliewi għandha tiġi mmonitorjata mill-qrib skont l-iskeda rakkomandata - Li l-pazjenti għandhom ikollhom il-funzjoni tal-kliewi tal-linja bażi tagħom ivvalutata qabel jibdew it-terapija bi Emtricitabine/Tenofovir disoproxil Krka - L-importanza tal-monitoraġġ regolari tal-funzjoni tal-kliewi matul it-terapija bi Emtricitabine/Tenofovir disoproxil Krka - L-iskeda rakkomandata għall-monitoraġġ tal-funzjoni tal-kliewi b'kunsiderazzjoni tal-preżenza jew in-nuqqas ta' fatturi addizzjonali ta' riskju għal indeboliment tal-kliewi - Istruzzjonijiet dwar l-użu tas-slide ruler tat-tneħħija tal-kreatinina
English: ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR = Time to Loss of Virologic Response a: Van Elteren Test
Maltese: * Il-pazjenti li jkunu qed jirċievu emtricitabine, tenofovir disoproxil u efavirenz ngħataw emtricitabine/tenofovir disoproxil flimkien ma' efavirenz minn ġimgħa 96 sa 144. ** Il-valur p ibbażat fuq it-Test ta' Cochran-Mantel-Haenszel stratifikat għal-linja bażi ta' l-għadd taċ-ċelluli CD4 TLOVR=Ħin sa nuqqas ta' respons viroloġiku a: Test ta' Van Elteren
English: Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite tenofovir disoproxil discontinuation (see section 4.4).
Maltese: Pazjenti f'riskju ta' indeboliment renali (bħal pazjenti b'fatturi ta' riskju renali fil-linja bażi, mard ta' l-HIV li jkun fi stadju avvanzat, jew pazjenti li jkunu qed jirċievu prodotti mediċinali nefrotossiċi fl-istess ħin) ghandhom riskju akbar li jkollhom irkupru mhux komplet tal-funzjoni renali minkejja t-twaqqif ta' tenofovir disoproxil (ara sezzjoni 4.4).
English: Risk Estimate for HIV-1 Protection:
Maltese: Riskju ta'reżistenza b'infezzjoni tal-HIV-1 mhux skoperta:
English: insomnia, abnormal dreams
Maltese: nuqqas ta' rqad, ħolm anormali
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Krka treatment - That Emtricitabine/Tenofovir disoproxil Krka may cause a reduction in BMD and the effects of Emtricitabine/Tenofovir disoproxil Krka associated changes in BMD on long term bone health and future fracture risk are currently unknown in paediatric patients - That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained
Maltese: - Li Emtricitabine/Tenofovir disoproxil Krka jista' jikkaġuna tnaqqis fil-BMD u l-effetti ta' Emtricitabine/Tenofovir disoproxil Krka marbuta ma' bidliet assoċjati ma' BMD fuq is-saħħa tal-għadam għal terminu ta' żmien twil, u riskju ta' ksur fil-futur huma attwalment mhux magħrufa f'pazjenti pedjatriċi.
English: In HIV-1 infected patients with renal risk factors, the co-administration of tenofovir disoproxil with a boosted protease inhibitor should be carefully evaluated.
Maltese: Madankollu, f'xi pazjenti infettati bl-HIV-1, tnaqqis fit-tneħħija tal-kreatinina m'għaddietx kompletament minkejja ttwaqqif ta' tenofovir disoproxil.
English: - HIV renal educational brochure - HIV pediatric renal educational brochure - PrEP educational brochure for prescribers entitled ‘Important Safety Information for
Maltese: - Opuskolu edukattiv dwar il-kliewi u l-HIV - Opuskolu edukattiv dwar il-kliewi u l-HIV fit-tfal - Opuskolu edukattiv dwar PrEP għal dawk li jagħtu r-riċetti bit-titolu ‘Tagħrif Importanti dwar is-Sigurtà għal Dawk li Jagħtu r-Riċetti Dwar Emtricitabine/Tenofovir disoproxil Krka għal
English: In study GS-US-104-0352, 97 treatment-experienced patients 2 to < 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
Maltese: Fl-istudju GS-US-104-0352, 97 pazjent b'esperjenza bil-kura bejn l-etajiet ta' sentejn sa < 12-il sena bi trażżin viroloġiku stabbli fuq korsijiet ta' kura li fihom stavudine jew zidovudine ġew magħżula b'mod każwali biex jissostitwixxu stavudine jew zidovudine ma' tenofovir disoproxil (n = 48) jew jibqgħu fuq il-kors ta' kura oriġinali tagħhom (n = 49) għal 48 ġimgħa.
English: A decreased dosage of 250 mg didanosine coadministered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Maltese: Dożaġġ imnaqqas ta' 250 mg ta' didanosine mogħti flimkien ma' terapija b'tenofovir disoproxil kien assoċjat ma' rapporti ta' rati għoljin ta' ħsara viroloġika f'diversi kumbinazzjonijiet li kienu ttestjati għat-trattament ta' infezzjoni bl-HIV-1.
English: (9.0%) discontinued study drug due to renal adverse events.
Maltese: Tmienja mid-89 pazjent (9.0%) waqqfu l-mediċina tal-istudju minħabba avvenimenti avversi renali.
English: Mean change from baseline in CD4 cell count (cells/mm p-value
Maltese: Bidla medja millinja bażi fl-għadd taċ-ċelluli CD4 (ċelluli/mm Valur p
English: Emtricitabine/Tenofovir disoproxil Krka should not be administered concomitantly (see section 4.4).
Maltese: Emtricitabine/Tenofovir disoproxil Krka flimkien ma' didanosine mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z score, and -0.184 and -0.027 in total body BMD Z score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Maltese: 032 u 0.087 fil-punteġġ Z tal-ispina lumbari, u -0.184 u -0.
English: Only Case or Cohort samples from subjects randomised to either tenofovir disoproxil 245 mg or emtricitabine/tenofovir disoproxil were evaluated for detectable plasma tenofovir levels.
Maltese: Huma biss il-kampjuni ta' Każ jew Koorti mill-individwi magħżula b'mod każwali għal tenofovir disoproxil 245 mg jew emtricitabine/tenofovir disoproxil li kienu evalwati għal livelli ta' tenofovir skoperti fil-plażma.
English: Hepatitis C virus (HCV) antiviral agents
Maltese: Pazjenti infettati kemm bl-HIV/HBV jew bl-HCV:
English: Lactic acidosis (see Possible serious side effects) fatty liver yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells softening of the bones (with bone pain and sometimes resulting in fractures) back pain caused by kidney problems
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna) - Aċidożi lattika (ara Effetti sekondarji serji possibbli) - fwied xaħmi - sfurija fil-ġilda jew l-għajnejn, ħakk, jew uġigħ ta' żaqq ikkawżat minn infjammazzjoni tal fwied - infjammazzjoni tal-kliewi, tgħaddi ħafna awrina u tħossok bil-għatx, falliment tal-kliewi, ħsara liċ-ċelluli tubuli tal-kliewi - trattib tal-għadam (b'uġigħ fl-għadam li kultant jirriżulta fi ksur) - uġigħ fid-dahar ikkawżat minn problemi fil-kliewi
English: Emtricitabine/Tenofovir disoproxil Krka should only be used for pre-exposure prophylaxis as part of an overall HIV-1 infection prevention strategy including the use of other HIV-1 prevention measures (e.g. consistent and correct condom use, knowledge of HIV-1 status, regular testing for other sexually transmitted infections).
Maltese: Emtricitabine/Tenofovir disoproxil Krka għandu jintuża biss għal profilassi ta' qabel l-esponiment bħala parti minn strateġija globali għall-prevenzjoni tal-infezzjoni tal-HIV-1 li tinkludi l-użu ta' miżuri ta' prevenzjoni oħrajn tal-HIV-1 (eż. l-użu konsistenti u korrett ta' kondoms, l-għarfien tal-istat talHIV-1, l-ittestjar regolari għal infezzjonijiet oħra trasmessi sesswalment).
English: BMD Z scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Maltese: 338 għall-ġisem kollu fl-64 individwu li ġew ittrattati b'tenofovir disoproxil għal 96 ġimgħa.
English: Film-coated tablet for blisters:
Maltese: Disturbi fil-fwied u fil-marrara:
English: Before taking Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV:
Maltese: Qabel tieħu Emtricitabine/Tenofovir disoproxil Krka biex tnaqqas ir-riskju li tieħu l-HIV:
English: AUC: ↑ 40% (↑ 34 to ↑ 45) Cmax: ↑ 46% (↑ 39 to ↑ 54) Cmin: ↑ 70% (↑ 61 to ↑ 79)
Maltese: Cmax: ↑ 46% (↑ 39 sa ↑ 54) Cmin: ↑ 70% (↑ 61 sa ↑ 79)
English: Co-administration is not recommended because it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Maltese: L-għoti ta' tenofovir disoproxil flimkien ma' didanosine mhuwiex rakkomandat għax jista' jirriżulta f'żieda ta' 40-60% fl-esponiment sistemiku għal didanosine li jista' jżid ir-riskju għal reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: Increased plasma concentrations of tenofovir resulting from co administration of tenofovir disoproxil, sofosbuvir/velpatasvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir u atazanavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Tenofovir disoproxil Krka.
Maltese: - Kun af l-istat tal-infezzjoni tal-virus tal-epatite B (HBV) tiegħek qabel tibda tieħu Emtricitabine/Tenofovir disoproxil Krka.
English: If you are taking Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV, take Emtricitabine/Tenofovir disoproxil Krka every day, not just when you think you have been at risk of HIV infection.
Maltese: Emtricitabine/Tenofovir disoproxil Krka jista' jgħin biss inaqqas ir-riskju tiegħek li tieħu l-HIV qabel tiġi infettat.
English: Lamivudine/Tenofovir disoproxil Lamivudine: AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12) Cmin: NC
Maltese: AUC: ↓ 3% (↓ 8% sa ↑ 15) Cmax: ↓ 24% (↓ 44 sa ↓ 12) Cmin: NC
English: Oral administration.
Maltese: Għoti orali.
English: See also under Use with ledipasvir and sofosbuvir or sofosbuvir and velpatasvir below.
Maltese: Ara wkoll taħt L-użu ma' ledipasvir u sofosbuvir jew sofosbuvir u velpatasvir hawn taħt.
English: Detected sided 95% CI)
Maltese: Tnaqqis firRiskju Relattiv (95% CI)
English: Increased plasma concentrations of tenofovir resulting from co administration of tenofovir disoproxil, sofosbuvir/velpatasvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir u darunavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: - Reminders for evaluations/counselling at the initial visit and follow-up.
Maltese: - Noti ta' tfakkir għal evalwazzjonijiet/konsulenza fil-viżita inizjali u s-segwitu.
English: You must be HIV negative before you start to take Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV.
Maltese: Trid tkun negattiv għall-HIV qabel tibda tieħu Emtricitabine/Tenofovir disoproxil Krka biex tnaqqas ir-riskju li tieħu l-HIV.
English: Adults with renal impairment:
Maltese: Individwi b'indeboliment renali:
English: Hepatobiliary disorders: Common:
Maltese: Indeboliment epatiku:
English: If serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving Emtricitabine/Tenofovir disoproxil Krka, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk il-fosfat fis-serum jiġi kkonfermat li hu < 3.0 mg/dL (0.96 mmol/L) fi kwalunkwe pazjent pedjatriku li jkun qed jirċievi Emtricitabine/Tenofovir disoproxil Krka, il-funzjoni renali għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, b'kejl li jinkludi l-glukożju fid-demm, potassju fid-demm u konċentrazzjonijiet tal-glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: High density polyethylene (HDPE) bottle with a child-resistant tamper evident polypropylene closure with integrated a silica gel desiccant.
Maltese: - Aċidożi lattika (ammont żejjed ta' aċidu lattiku fid-demm) hu effett sekondarju rari iżda potenzjalment ta'theddida għall-ħajja.
English: Renal management in pre-exposure prophylaxis
Maltese: Profilassi ta' qabel l-esponiment
English: 3, respectively.
Maltese: 3 u
English: Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV infection - Reminder on the importance of strict adherence to the recommended dosing regimen - Provides information on how to take Emtricitabine/Tenofovir disoproxil Krka - Provides information on the possible side effects - Provides information on how to store Emtricitabine/Tenofovir disoproxil Krka.
Maltese: Emtricitabine/Tenofovir disoproxil Krka biex inaqqas ir-riskju li jieħu infezzjoni tal-HIV - Nota ta' tfakkir dwar l-importanza ta' aderenza stretta mal-kors tad-doża rakkomandat - Jagħti tagħrif dwar kif tieħu Emtricitabine/Tenofovir disoproxil Krka - Jagħti tagħrif dwar l-effetti sekondarji possibbli - Jagħti tagħrif dwar kif taħżen Emtricitabine/Tenofovir disoproxil Krka.
English: Very common side effects (may affect more than 1 in 10 people) diarrhoea, being sick (vomiting), feeling sick (nausea) dizziness, headache rash feeling weak
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni) - dijarea, tibda tirremetti (rimettar), tħossok imdardar (nawsea) - sturdament, uġigħ ta' ras - raxx - tħossok dgħajjef
English: Cmin: ↑ 42% (↑ 34 to ↑ 49) Atazanavir:
Maltese: Cmin: ↑ 42% (↑ 34 sa ↑ 49)
English: Tenofovir disoproxil Group
Maltese: Grupp tat-tenofovir disoproxil
English: Co-administration of tenofovir disoproxil and didanosine:
Maltese: Tenofovir disoproxil:
English: The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5-fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40fold the exposure in patients).
Maltese: It-tossiċità fl-għadam f'firien u klieb adulti żgħażagħ seħħet f'esponimenti li kienu ≥ 5-darbiet iżjed mill-esponiment f'pazjenti pedjatriċi jew adulti; it-tossiċità fl-għadam seħħet f'xadini ġuvenili infettati f'esponimenti għoljin ħafna wara dożaġġ taħt il-ġilda (≥ 40-darba iżjed mill-esponiment fil-pazjenti).
English: OPA/Alu/PE+DES/ - Aluminium blisters.
Maltese: OPA/Alu/PE+DES/ - Folji tal-aluminju Daqs tal-pakkett: 28 u 84 pillola miksija b'rita.
English: AUC: ↑ 98% (↑ 77 to ↑ 123)
Maltese: AUC: ↑ 40% (↑ 34 sa ↑ 45)
English: Use with ledipasvir and sofosbuvir, sofosbuvir and velpatasvir or sofosbuvir, velpatasvir and voxilaprevir
Maltese: Hu importanti wkoll li tgħid lit-tabib tiegħek jekk qed tieħu ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir biex tittratta infezzjoni bl-epatite Ċ.
English: Section 4.3 “Contraindications” “Somatropin must not be used when there is any evidence of activity of a tumour.
Maltese: Sezzjoni 4.3 “Kontra-indikazzjonijiet” “Somatropin ma għandux jintuża meta jkun hemm xi evidenza ta' attività ta' tumur.
English: Section 4.4 “Special warnings and precautions for use” “The maximum recommended daily dose should not be exceeded (see section 4.2).”
Maltese: Sezzjoni 4.4 “Twissijiet speċjali u prekawzjonijiet għall-użu” “Id-doża massima ta' kuljum rakkomandata ma għandhiex tinqabeż (ara Sezzjoni 4.2).”
English: Amendments to the Summary of Product Characteristics and Package Leaflet for all somatropin medicinal products:
Maltese: Emendi għas-Sommarju tal-Karatteristiċi tal-Prodott u Fuljett ta' Tagħrif għall-prodotti kollha li fihom somatropin:
English: Package Leaflet
Maltese: Sommarju tal-Karatteristiċi tal-Prodott
English: Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting GH therapy.
Maltese: It-tumuri għandhom ikunu inattivi u inti għandek tkun temmejt il-kura kontra t-tumuri qabel tibda l-kura tiegħek b'<Isem il-prodott mediċinali (inventat)>.
English: Annex III
Maltese: Fuljett ta' Tagħrif
English: Note: These amendments to the summary of product characteristics and package leaflet are valid at the time of the Commission Decision.
Maltese: Nota: Dawn l-emendi għas-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif huma valida fiż-żmien tad-Deċiżjoni tal-Kummissjoni.
English: Before you use <(Invented) name of the product> Do not use <(Invented) name of the product> and tell your doctor if you have an active tumour (cancer).
Maltese: X'għandek tkun taf qabel ma tuża <(Isem il-prodott mediċinali (inventat)> Tużax <isem il-prodott mediċinali (inventat)> u għid lit-tabib tiegħek jekk għandek tumur attiv (kanċer).
English: 20 to 30 minutes
Maltese: 20 sa 30 minuta
English: 1.5 L to 2.2 L
Maltese: 1.5 L sa 2.2 L
English: DK, EE, FI, NO, SE SAM Nordic
Maltese: DK, EE, FI, NO, SE SAM
English: ** CTCAE: Common Terminology Criteria for Adverse Events, National Cancer Institute
Maltese: Common Terminology Criteria for Adverse Events, National Cancer Institute
English: Polígono Industrial la Cuesta - Sector 3 Parcelas 1 y 2 La Almunia de Doña Godina 50100 Zaragoza
Maltese: Polígono Industrial la Cuesta - Sector 3 Parcelas 1 y 2 La Almunia de Doña Godina 50100
English: Antiemetic bolus
Maltese: Antiemetiku bolus
English: 01630 Saint Genis Pouilly France
Maltese: 01630 Saint Genis Pouilly Franza
English: Between 18 and 24 g
Maltese: Bejn 18 u 24 g
English: Colleretto Giacosa (TO) Italy
Maltese: Colleretto Giacosa (TO) L-Italja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1226/001
Maltese: EU/1/17/1226/001
English: No data are available.
Maltese: Ma hemm ebda data disponibbli.
English: Low gamma energy is also emitted, for instance at 113 keV (6.2%) and 208 keV (11%).
Maltese: pereżempju f'113 keV (6.2%) u 208 keV (11%).
English: • Liver function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumin,
Maltese: • Funzjoni tal-fwied (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumina, bilirubina)
English: Tumour type n % n % N % n % 95%CI Median 95%CI
Maltese: Tip ta' tumur n % n % N % n % CI ta' 95% Medjan CI ta' 95%
English: Quality controls
Maltese: Kontrolli tal-kwalità
English: Pancreatic 133 7 5% 74 56% 47 35% 81 61% 52% 69% 16.3 12.1 21.8 Foregut** 12 1 8% 6 50% 4 33% 7 58% 28% 85% 22.3 0.0 38.0 Midgut
Maltese: Pankreatiku 133 7 5% 74 56% 47 35% 81 61% 52% 69% 16.3 12.1 21.8 Fil-parti anterjuri talimsaren*** 12 1 8% 6 50% 4 33% 7 58% 28% 85% 22.3 0.0
English: − Antiemetics
Maltese: − Antiemetiċi
English: MedDRA System Organ Class (SOC)
Maltese: Sistema tal-klassifika talorgani (SOC) tal-MedDRA
English: • Urinary incontinence;
Maltese: • Inkontinenza tal-awrina;
English: Leukopenia5 Neutropenia6
Maltese: Lewkopenja5 Newtropenja6
English: Arginine content
Maltese: Kontenut ta' arginine
English: Staphylococcal infections Streptococcal bacteraemia
Maltese: Infezzjonijiet staphylococcal Batteremija streptococcal
English: • Bilirubinemia > 3 times the upper limit of normal,
Maltese: • Bilirubinemija > 3 darbiet il-limitu ta' fuq tan-normal,
English: General rule
Maltese: Regola ġenerali
English: Individual benefit/risk justification
Maltese: Ġustifikazzjoni tal-benefiċċju/riskju individwali
English: p-value of Log-rank test Hazard ratio (95%-CI)
Maltese: Valur-p tat-test Log-rank Proporzjon tal-periklu (95%-CI)
English: Duration
Maltese: Durata
English: Musculoskeletal pain8 Muscle spasms
Maltese: Uġigħ muskoluskeletriku8 Spażmi fil-muskoli
English: Lutetium (177Lu) decays by β- emission to stable Hafnium (177Hf) with the most abundant β- (79.3%) having a maximum energy of 0.497 MeV.
Maltese: Lutetium (177Lu) jiddegrada permezz tal-emissjoni ta' β- għal Hafnium stabbli (177Hf) bil-β- (79.3%) l-aktar abbundanti li għandu enerġija massima ta' 0.497 MeV.
English: Severe heart failure (defined as grade III or IV of the New York Heart Association (NYHA) classification)
Maltese: Insuffiċjenza tal-qalb severa (definita bħala tal-grad III jew IV tal-klassifikazzjoni tan-New York Heart Association (NYHA))
English: N: number of patients, CI: confidence interval.
Maltese: N: numru ta' pazjenti, CI: intervall ta' kunfidenza.
English: Amino acid solution, either extemporaneously compounded (1 L) or commercial (1.5 L to 2.2 L)
Maltese: Soluzzjoni ta' aċidi amminiċi, komposta b'mod esterporanju (1 L) jew kummerċjali (1.5 L sa 2.2 L)
English: Blood catecholamines c-reactive protein increased
Maltese: Catecholamines fid-demm Żieda fil-proteina c-reattiva
English: This medicinal product contains up to 3.5 mmol (81.1 mg) sodium per dose.
Maltese: Dan il-prodott mediċinali fih sa 3.5 mmol (81.1 mg) sodium kull doża.
English: The absence of inhibition or significant induction of the human CYP450 enzymes, the absence of specific interaction with P-glycoprotein (efflux transporter) as well as OAT1, OAT3, OCT2, OATP1B1, OATP1B3, OCT1 and BCRP transporters in pre-clinical studies suggest that Lutathera has a low probability of causing significant other drug-drug interactions.
Maltese: In-nuqqas ta' inibizzjoni jew induzzjoni sinifikanti tal-enzimi ta' CYP450 tal-bniedem, in-nuqqas ta' interazzjoni speċifika ma' P-glycoprotein (trasportatur tal-effluss) kif ukoll ma' trasportaturi ta' OAT1, OAT3, OCT2, OATP1B1, OATP1B3, OCT1 u BCRP fi studji ta' qabel l-użu kliniku jissuġġerixxu li Lutathera għandu probabbiltà baxxa li jikkawża interrazzjonijiet sinifikanti ma' mediċini oħra.
English: Ovaries**
Maltese: Utru**
English: Gravity infusion method - tubing connection scheme
Maltese: Il-metodu tal-infużjoni bil-gravità - skema tal-konnessjoni tat-tubu
English: Infusion rate (mL/h)
Maltese: Rata ta' infużjoni (mL/siegħa)
English: Precautions with respect to environmental hazard see section 6.6.
Maltese: Għal prekawzjonijiet kontra periklu ambjentali ara sezzjoni 6.6.
English: In the Erasmus phase I/II study 188 patients (52%) received and 172 (48%) did not receive concomitant octreotide LAR during Lutathera treatment.
Maltese: Fl-istudju tal-fażi I/II Erasmus 188 pazjent (52%) irċevew u 172 (48%) ma rċevewx octreotide LAR
English: Herpes zoster Ophthalmic herpes zoster Influenza
Maltese: Herpes zoster oftalmika
English: Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC}
Maltese: Attività fil-ħin tal-infużjoni: {Z} MBq - {JJ/XX/SSSS hh:mm UTC}
English: For additional details about the treatment of patient with renal impairment see Table 5 in section 4.2 and section 4.4.
Maltese: Għal aktar dettalji dwar il-kura ta' pazjenti b'indeboliment tal-kliewi ara Tabella 5 f'sezzjoni 4.2 u sezzjoni 4.4.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Maltese: IDENTIFIKATUR UNIKU -BARCODE 2D Mhux applikabbli.
English: Organ absorbed dose (mGy/MBq) (n = 20)
Maltese: Doża assorbita mill-organu (mGy/MBq)
English: Lutathera should be administered over 20 to 30 minute time span.
Maltese: Lutathera għandha tingħata għal 20 sa 30 minuta.
English: Vial No.: {X}
Maltese: MBq kull waħda.