FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with strontium ranelate after careful consideration (see sections 4.3 and 4.8).
Maltese: Pazjenti b'fatturi ta' riskju sinifikanti għal episodji kardjovaskulari (eż. pressjoni għolja, lipidemija għolja, dijabete mellitus, tipjip) għandhom jiġu kkurati bi strontium ranelate wara kunsiderazzjoni bir reqqa (ara sezzjonijiet 4.3 u 4.8).
English: Eλλάδα ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ
Maltese: Κύπρος
English: How to take osseor
Maltese: OSSEOR Tnaqqis fir-Riskju
English: These effects were reported at bone strontium levels 2-3 times higher than bone strontium levels in humans up to 3 years of treatment.
Maltese: Dawn l-effetti kienu rrappurtati b'livelli ta' strontium fl-għadam ta' 2-3 darbiet ogħla mil-livelli ta' strontium fl-għadam fil-bnedmin sa 3 snin ta' kura.
English: In this group, over 3 years of treatment, OSSEOR reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Maltese: ksur tal-ġenb b'36% meta mqabbel mal-grupp bi plaċebo.
English: However, it is recommended to drink the suspension immediately after preparation (see section 4.2) 6.4 Special precautions for storage
Maltese: Madankollu huwa rrakkommandat li s-sospensjoni tinxtorob immedjatamet wara li titħejja (ara sezzjoni 4.2)
English: Excipient OSSEOR contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Maltese: Eċċipjenti OSSEOR għandu sors ta' phenylalanine, li jista' jkun ta' ħsara f'nies b'phenylketonuria.
English: Strontium ranelate does not modify the bone crystal characteristics.
Maltese: Strontium ranelate ma jibdilx il-karatterstiċi tal-kristall tal-għadam.
English: The highest risk of occurrence of serious skin reactions is within the first weeks of treatment for Stevens-Johnson syndrome and toxic epidermal necrolysis and usually around 3-6 weeks for DRESS.
Maltese: L-ogħla riskju ta' okkorrenza ta' reazzjonijiet serji tal-ġilda jseħħ fl-ewwel ġimgħat tal-kura għassindromu ta' Stevens-Johnson u nekroliżi epidermali tossika u normalment madwar 3-6 ġimgħat għal
English: OSSEOR is for oral use.
Maltese: OSSEOR jiġi fi qratas li fihom granijiet sofor għal sospensjoni orali.
English: In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), OSSEOR reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
Maltese: F'analiżi posterjuri ta' pazjenti mill-istudji SOTI u TROPOS miġbura flimkien b'bażi lumbari talispina u/jew tal-għonq tal-femur BMD fil-wisa' osteopenika u mingħajr ksur prevelanti iżda mill inqas b'fattur ta' riskju addizjonali għall-ksur (N = 176), OSSEOR naqqas ir-riskju li jkun hemm lewwel ksur tas-sinsla b'72% tul 3 snin (inċidenza ta' ksur tas-sinsla 3.6% bi strontium ranelate vs.
English: • Importance of regularly monitoring cardiovascular risk.
Maltese: L-importanza li timmonitorja b'mod regolari r-riskji kardjovaskulari.
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of OSSEOR.
Maltese: nekroliżi epidermali tossika u reazzjonijiet severi dovuti ta' ipersensittività (DRESS)) ġew irrapportati bl-użu ta' OSSEOR.
English: If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of OSSEOR, you must not be re-started on OSSEOR at any time If you develop a rash or these skin symptoms, stop taking OSSEOR, seek urgent advice from a doctor and tell him that you are taking this medicine.
Maltese: Jekk żviluppajt is-sindromu ta' Stevens-Johnson jew nekroliżi epidermali tossika jew DRESS bl-użu ta' OSSEOR, inti qatt ma għandek terġa' tieħu OSSEOR.
English: Uncontrolled hypertension.
Maltese: Mhux applikabbli.
English: About osteoporosis
Maltese: Relattiv vs. plaċebo
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect 1 in 10 people uncommon: mayaffect 1 in 100 people rare: mayaffect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Maltese: komuni: tista' taffettwa sa persuna 1 minn kull 10 mhux komuni: tista' taffettwa sa persuna 1 minn kull 100 rari: tista' taffettwa sa persuna 1 minn kull 1000
English: How to store OSSEOR
Maltese: Jekk tinsa tieħu OSSEOR
English: Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration 3 hours after a meal.
Maltese: Jekk strontium ranelate jittieħed ma' kalċju jew mal-ikel, dan inaqqas il-bijodisponibiltà ta' strontium bejn wieħed u ieħor b'60%-70%
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/003
Maltese: EU/1/04/287/003
English: • OSSEOR should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
Maltese: • OSSEOR għandu jintuża biss b'kawtela f': o Pazjenti b'fatturi ta' riskju sinifikanti għal episodji kardjovaskulari bħal pressjoni għolja, iperlipidemija, diabetes mellitus jew tipjip.
English: During OSSEOR treatment, these cardiovascular risks should be monitored on a regular basis generally every 6 to 12 months.
Maltese: Matul kura bi OSSEOR, dawn ir-riskji kardjovaskulari għandhom jiġu mmonitorjati fuq bażi regolari, ġeneralment kull 6 xhur sa 12-il xahar.
English: BATCH NUMBER Batch
Maltese: NUMRU TAL-LOTT LOTT
English: - if you are at risk of blood clots.
Maltese: - jekk għandek riskju ta' emboli tad-demm.
English: In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, OSSEOR is not recommended in patients with a creatinine clearance below 30 ml/min (see section 5.2).
Maltese: Fin-nuqqas ta' tagħrif dwar is-sigurtà fl-għadam f'pazjenti b'indeboliment sever tal-kliewi fuq kura bi strontium ranelate, OSSEOR mhuwiex irrakkomandat f'pazjenti b'eliminazzjoni tal-kreatinina ta' inqas minn 30 ml/min (ara sezzjoni 5.2).
English: A higher incidence, although still rare, of hypersensitivity reactions including skin rash, SJS or TEN in patients of Asian origin has been reported.
Maltese: Ġiet irrapportata inċidenza ogħla, għalkemm xorta rari, ta' reazzjonijiet ta' sensittività eċċessiva inkluż raxx tal-ġilda, SJS jew TEN f'pazjenti ta' oriġini Asjatika.
English: Luxembourg/Luxemburg S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 11
Maltese: Luxembourg/Luxemburg S.A. Servier Benelux N.V.
English: Food, milk and milk products reduce the absorption of strontium ranelate.
Maltese: L-ikel, il-ħalib u prodotti magħmulin mill-ħalib inaqqsu l-assorbiment ta' strontium ranelate.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/002
Maltese: EU/1/04/287/002
English: Population pharmacokinetic data showed no relationship between age and apparent clearance of strontium in the target population.
Maltese: It-tagħrif farmakokinetiku fil-popolazzjoni ma wera l-ebda relazzjoni bejn l-età u l-eliminazzjoni apparenti ta' strontium fil-popolazzjoni indikata.
English: The newly formed bone is of normal quality.
Maltese: L-għadam iffurmat mill-ġdid huwa ta' kwalità normali.
English: Not known:
Maltese: Rari ħafna:
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in OSSEOR treated patients compared to placebo (see section 4.8).
Maltese: Fi studji ta' pazjenti b'osteoporożi ta' wara l-menopawsa miġburin randomizzati u kkontrollati bi plaċebo, ġiet osservata żieda sinifikanti f'infart mijokardijaku f'pazjenti kkurati bi OSSEOR meta mqabbel ma' plaċebo (ara sezzjoni 4.8)
English: Stevens-Johnson syndrome and toxic epidermal necrolysis appear initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Maltese: Ħafna nies b'osteoporożi ma jkollhomx sintomi u inti tista' lanqas biss tinduna li jkollok losteoporożi.
English: Measurement of strontium concentration in iliac crest bone biopsies from patients treated for up to 60 months with strontium ranelate 2 g/day indicate that bone strontium concentrations may reach a plateau after about 3 years of treatment.
Maltese: Il-kejl tal-konċentrazzjoni ta' strontium f'bijopsiji tal-għadam mill-krest tal-ilju ta' pazjenti trattati sa 60 xahar bi strontium ranelate 2 g/jum jindikaw li l-konċentrazzjoni ta' strontium fl-għadam tista' tilħaq limitu wara bejn wieħed u ieħor 3 snin ta' kura.
English: With respect to clinical vertebral fractures (defined as fractures associated with back pain and/or a body height loss of at least 1 cm), the relative risk was reduced by 38%.
Maltese: Meta tħares lejn il-ksur kliniku tas-sinsla (iddefinit bħala ksur assoċjat ma' uġigħ fid-dahar u/jew telf fit-tul tal-ġisem ta' mill-inqas 1 ċm) ir-riskju relattiv naqas b'38%.
English: How are melissa leaf medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini tal-werqa ta' nagħniegħ in-naħal?
English: This may be used to prepare extracts or tinctures (an alcoholic extract of the plant material).
Maltese: Din tista' tintuża għall-preparazzjoni ta' estratti jew tinturi (estratt alkoħoliku tal-materjal tal-pjanta).
English: The HMPC also considered published clinical studies, including a small study that examined the effects of melissa leaf preparations on symptoms of mild to moderate anxiety and sleep disturbance.
Maltese: L-HMPC ikkunsidra studji kliniċi ppubblikati, inkluż studju żgħir li eżamina leffetti ta' preparazzjonijiet tal-werqa ta' nagħniegħ in-naħal fuq is-sintomi ta' ansjetà ħafifa għal moderata u disturb fl-irqad.
English: Further information on the risks associated with melissa leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini tal-werqa ta' nagħniegħ in-naħal, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: Further information on the HMPC assessment of melissa leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Melissa leaf
Maltese: Tagħrif dettaljat dwar
English: The HMPC conclusions on the use of melissa leaf medicines for mild symptoms of stress, sleep aid and mild digestive disorders are based on their ‘traditional use' in these conditions.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu tal-mediċini tal-werqa ta' nagħniegħ in-naħal huma bbażati fuq l-‘użi tradizzjonali' tagħhom.
English: Moreover, the intended uses do not require medical supervision.
Maltese: Barra minn hekk, lużu maħsub ma jeħtieġx superviżjoni medika.
English: Melissa leaf should only be used in adults and children over the age of 12 years.
Maltese: Il-werqa ta' nagħniegħ in-naħal għandha tintuża biss f'persuni adulti u tfal ta' 'l fuq minn 12-il sena.
English: Melissa leaf is the common name for the leaf of the plant Melissa officinalis L. The plant is cultivated or gathered to obtain the leaf for medicinal use.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom kif għandhom jittieħdu l-mediċini tal-werqa ta' nagħniegħ in-naħal u min jista' jużahom jista' jinstab fil-fuljett ta' tagħrif li jakkumpanja l-mediċina.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of melissa leaf.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għall-Prodotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-werqa ta' nagħniegħ in-naħal.
English: Herbal medicines containing melissa leaf are usually available as a herbal tea to be drunk, and in solid and liquid forms to be taken by mouth.
Maltese: Il-mediċini erbali li fihom il-werqa ta' nagħniegħ in-naħal ġeneralment jiġu bħala te erbali biex jinxtorob, u f'forom solidi u likwidi li għandhom jittieħdu mill-ħalq.
English: • Male: 84%
Maltese: • Irġiel: 84%
English: Pancreatitis i,†
Maltese: Pankreatite i,†
English: Proteinuria‡
Maltese: Proteinurija‡
English: ORRc, f, g (mRECIST)
Maltese: ORRc, f, g (mRECIST) NA
English: • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0: 63%, ECOG PS of
Maltese: • Eastern Cooperative Oncology Group Performance Status (ECOG PS) ta' 0: 63%, ECOG PS ta'
English: • Median age: 62 years
Maltese: • Età medjana: 62 sena
English: Placebo N=131
Maltese: Plaċebo N=131
English: • Body weight: <60 kg -31%, 60-80 kg - 50%, >80 kg - 19%
Maltese: • Piż tal-ġisem: <60 kg -31%, 60-80 kg - 50%, >80 kg - 19%
English: System Organ Class (MedDRA terminology*)
Maltese: Sistema talKlassifika talOrgani (Terminoloġija MedDRA*)
English: Increased alanine aminotransferase ‡
Maltese: Żieda f'alanine aminotransferase ‡
English: Nephrotic syndrome ------
Maltese: Sindrome nefrotiku ------
English: Increased aspartate aminotransferase ‡
Maltese: Żieda f'aspartate aminotransferase ‡
English: • White: 29%, Asian: 69%, Black or African American: 1.4%
Maltese: • Bojod: 29%, Asjatiċi: 69%, Suwed jew Afrikani Amerikani: 1.4%
English: Median (95% CI) e Lenvatinib (N= 478)
Maltese: Medjan (95% CI) e Lenvatinib (N=478)
English: • Absence of macroscopic portal vein invasion (MPVI): 79%
Maltese: • Assenza ta' invażjoni makroskopika tal-vina portali (MPVI): 79%
English: Age, sex, weight, race
Maltese: Età, sess tal-persuna, piż, razza
English: Grades are based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Maltese: Il-gradi huma bbażati fuq in-National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
English: • Barcelona Clinic Liver Cancer (BCLC) stage B: 20%; BCLC stage C: 80%
Maltese: • Barcelona Clinic Liver Cancer (BCLC) stadju B: 20%;
English: • Aetiology: Hepatitis B (50%), Hepatitis C (23%), alcohol (6%)
Maltese: Epatite B (50%), Epatite C (23%), alkoħol (6%)
English: • The active substance is lenvatinib.
Maltese: • Is-sustanza attiva hi lenvatinib.
English: Differentiated Thyroid Cancer (DTC)
Maltese: Kanċer Differenzjat tat-Tirojde (Differentiated Thyroid Cancer, DTC)
English: Data cut-off date = 13 Nov 2016.
Maltese: Data ta' skadenza għad-dejta: 13 ta' Novembru 2016.
English: CI, confidence interval; NE, not estimable.
Maltese: CI, intervall tal-kunfidenza; NE, mhux estimabbli.
English: Palmar-plantar erythrodysaesthesia syndrome Rash Alopecia
Maltese: Sindrome ta' eritrodisestesija palmar-plantar Raxx Alopeċja
English: Pancreatitis includes: pancreatitis and acute pancreatitis.
Maltese: Pankreatite tinkludi: pankreatite u pankreatite akuta.
English: Interrupt
Maltese: Interrompi
English: Grade 4*
Maltese: Grad 4*
English: Independent radiologic review.
Maltese: Evalwazzjoni radjoloġika indipendenti.
English: Lenvatinib is a substrate for P-gp and BCRP.
Maltese: Lenvatinib hu substrat għal P-gp u BCRP.
English: Pulmonary embolism†,
Maltese: Emboliżmu pulmonari†
English: Patients were eligible to participate if they had a liver function status of Child-Pugh class A and Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
Maltese: Pazjenti kienu eliġibbli li jipparteċipaw jekk kellhom stat ta' funzjoni tal-fwied ta' Child-Pugh klassi A u Eastern Cooperative Oncology Group Performance Status (ECOG PS) ta' 0 jew 1.
English: Table 6
Maltese: Tabella 5
English: Each carton contains 30 ,60,or 90 hard capsules.
Maltese: Kull pakkett fih 30, 60, jew 90 kapsula iebsa.
English: Resolves to less than 2 g / 24 hours.
Maltese: Titjieb għal inqas minn 2 g/24 siegħa.
English: Systolic BP ≥140 mmHg up to <160 mmHg or diastolic BP ≥90 mmHg up to <100 mmHg
Maltese: BP sistolika ta' ≥140 mmHg sa <160 mmHg jew BP dijastolika ta' ≥90 mmHg sa <100 mmHg
English: Lenvatinib is not a substrate for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, MATE1, MATE2-K or the bile salt export pump BSEP.
Maltese: Lenvatinib mhuwiex substrat għal OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, MATE1, MATE2-K jew il-bile salt export pump BSEP.
English: Manufacturer Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.
Maltese: Manifattur Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, Ir-Renju Unit.
English: Noninferiority margin for hazard ratio (HR: lenvatinib vs sorafenib = 1.08).
Maltese: Marġini ta' non-inferjorità għall-proporzjon ta' periklu (HR: lenvatinib vs sorafenib = 1.08).
English: ≥ 2 g / 24 hours
Maltese: ≥ 2 g/24 siegħa
English: Kaplan-Meier Curve of Progression-Free Survival - DTC
Maltese: Kaplan-Meier ta' Sopravivenza Mingħajr Progressjoni - DTC
English: Similar adverse reactions were observed in clinical trials in DTC and HCC.
Maltese: Reazzjonijiet avversi simili ġew osservati fil-provi kliniċi f'DTC u HCC.
English: No data are available.
Maltese: Ebda dejta mhi disponibbli.
English: Grade 3 (despite optimal antihypertensive therapy)
Maltese: Grad 3 (minkejja terapija ottimali kontra l-pressjoni għolja)
English: The following terms have been combined: a:
Maltese: It-termini li ġejjin ġew ikkombinati: a:
English: Capsule shell Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Maltese: Qoxra tal-kapsula Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
English: European Knowledge Centre, Mosquito Way, Hatfield, Herfordshire, AL10 9SN, United Kingdom Or
Maltese: Eisai Manufacturing Ltd European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ir-Renju Unit
English: In vitro, cytochrome P450 3A4 was demonstrated as the predominant (>80%) isoform involved in the P450-mediated metabolism of lenvatinib.
Maltese: In vitro, ċitokrom P450 3A4 intwera bħala l-isoforma predominanti (>80%) involuta fil-metaboliżmu medjat minn P450 ta' lenvatinib.
English: • Underlying cirrhosis (by independent imaging review): 75%
Maltese: • Ċirrożi sottostanti (minn evalwazzjoni indipendenti tal-immaġni): 75%
English: Dose proportionality and accumulation
Maltese: Proporzjonalità u akkumulazzjoni tad-doża
English: EU/1/15/1002/002 (Pack size of 30 hard capsules) EU/1/15/1002/005 (Pack size of 60 hard capsules) EU/1/15/1002/006 (Pack size of 90 hard capsules)
Maltese: EU/1/15/1002/002 (Daqs tal-pakkett ta' 30 kapsula iebsa) EU/1/15/1002/004 (Daqs tal-pakkett ta' 60 kapsula iebsa) EU/1/15/1002/006 (Daqs tal-pakkett ta' 90 kapsula iebsa)
English: • The other ingredients are calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose, talc.
Maltese: • Is-sustanzi l-oħra huma calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose, talc.
English: • increase in lipase and amylase (enzymes involved in digestion)
Maltese: • żieda fil-lipase u f'amylase (enzimi involuti fid-diġestjoni)
English: The M3 metabolite was the predominant analyte in excreta (~17% of the dose), followed by M2' (~11% of the dose) and M2 (~4.4 of the dose).
Maltese: Il-metabolit M3 kien l-analit predominanti fl-ippurgar (~17% tad-doża), segwit minn M2' (~11% tad-doża) u M2 (~4.4 tad-doża).
English: P-value d
Maltese: Valur P
English: Thrombocytopeniaa Leukopeniaa Neutropeniaa
Maltese: Tromboċitopenijaa Lewkopenijaa Newtropenijaa
English: For the following transporters, OAT1, OAT3, OATP1B1, OCT1, OCT2, and BSEP, clinically relevant inhibition was excluded based on a cutoff of IC50> 50  Cmax,unbound.
Maltese: Għat-trasportaturi li ġejjin, OAT1, OAT3, OATP1B1, OCT1, OCT2, u BSEP, inibizzjoni klinikament rilevanti ġiet eskluża abbażi l-cutoff ta' IC50> 50  Cmax,unbound.
English: • Prior treatments: hepatectomy (28%), radiotherapy (11%), loco-regional therapies including transarterial (chemo)embolisation (52%), radiofrequency ablation (21%) and percutaneous ethanol injection (4%)
Maltese: • Kuri preċedenti: epatektomija (28%), radjuterapija (11%), terapiji lokoreġjonali inkluż il kemoembolizzazzjoni transarterjali (52%), ablazzjoni bir-radjufrekwenza (21%) u injezzjoni tal ethanol mill-ġilda (4%)
English: 10 mg orally once dailya One 10mg capsule a:
Maltese: Kapsula waħda ta' 10 mg a:
English: • Absence of MPVI, extra-hepatic tumour spread (EHS) or both: 30%
Maltese: • Assenza ta' MPVI, firxa tat-tumur barra mill-fwied (extra-hepatic tumour spread, EHS) jew it tnejn: 30%
English: Polyamide/Aluminium/PVC/Aluminium blisters containing 10 capsules.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folji tal-polyamide/Aluminium /PVC/Aluminium li fihom 10 kapsuli.
English: Splenic infarction
Maltese: Infart spleniku
English: Kaplan-Meier Curve of Overall Survival - HCC
Maltese: Figura 2: Kurva ta' Kaplan-Meier ta' Sopravivenza Globali - HCC
English: The analogous median apparent volume of distribution at steady-state (Vz/Fss) was also generally consistent and ranged from 43.2 L to 121 L.
Maltese: Il-volum apparenti medjan analogu tad-distribuzzjoni fl-istat fiss (Vz/FSS) kien ukoll ġeneralment konsistenti u varja minn 43.2 L sa 121 L.
English: Resolves to <480 ms or baseline
Maltese: Jitjieb għal <480 ms jew għallinja bażi
English: See section 4.2 for dosing recommendation.
Maltese: Ara sezzjoni 4.2 għal rakkomandazzjoni dwar id-dożaġġ.
English: • weigh less than 60 kg
Maltese: • tiżen inqas minn 60 kg
English: Percentages (95% CI)
Maltese: Perċentwali (95% CI)
English: Cardiac dysfunction Grade 3
Maltese: Indeboliment jew Grad 3
English: Date of first authorisation: 28 May 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 28 ta' Mejju, 2015
English: (1 capsule of 10 mg and 1 capsule of 4 mg).
Maltese: 10 mg u 1 kapsula ta' 4 mg).
English: Based on AUC(0 - inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively.
Maltese: Ibbażat fuq l-AUC(0 - inf), lenvatinib ammonta għal 60% u 64% tar-radjuattività totali filplażma u fid-demm, rispettivament.
English: Consequently, in vivo, inducers and inhibitors of CYP 3A4 had a minimal effect on lenvatinib exposure (see section 4.5).
Maltese: Konsegwentement, in vivo, indutturi u inibituri ta' CYP 3A4 kellhom effett minimu fuq l-esponiment ta' lenvatinib (ara sezzjoni 4.5).
English: Adjusted Doseb (≥60 kg BW)
Maltese: Doża Aġġustatab (≥60 kg BW)
English: Anal fistula Flatulence Increased lipase Increased amylase
Maltese: Fistula anali Gass Żieda fil-lipase Żieda f'amylase
English: Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS)
Maltese: Sindrome ta' enċefalopatija riversibbli posterjuri (PRES - Posterior reversible encephalopathy syndrome)/Sindrome ta' lewkoenċefalopatija posterjuri riversibbli (RPLS - Reversible Posterior Leucoencephalopathy Syndrome)
English: In vitro transporter studies
Maltese: Studji dwar it-trasportaturi in vitro
English: Over this range, the median accumulation index (Rac) ranged from 0.96 (20 mg) to 1.54 (6.4 mg).
Maltese: Fuq din il-medda, l-indiċi ta' akkumulazzjoni medjan (Rac) varja minn 0.96 (20 mg) sa 1.54 (6.4 mg).
English: • Common
Maltese: • Komuni
English: Leave for at least 10 minutes then stir for at least 3 minutes to dissolve the capsule shells.
Maltese: Ħallihom għal mill-inqas 10 minuti u mbagħad ħawwad għal mill-inqas 3 minuti biex tħoll ilqxur tal-kapsuli.