FrancophonIA/ELRC3.0 huggingface dataset:
English: g 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Maltese: 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 144 ġimgħa open-label.
English: Tenofovir disoproxil Zentiva is not usually taken with other medicines that can damage your kidneys (see Other medicines and Tenofovir disoproxil Zentiva).
Maltese: Tenofovir disoproxil Zentiva normalment ma jitteħidx ma' mediċini oħra li jistgħu jagħmlu ħsara lill-kliewi tiegħek (ara Mediċini oħra u Tenofovir disoproxil Zentiva).
English: In the tenofovir disoproxil treatment arm, 7% of patients discontinued treatment due to an adverse event; 9% of patients experienced a confirmed increase in serum creatinine of ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl through week 48; there were no statistically significant differences between the combined tenofovir-containing arms and the entecavir arm. After 168 weeks, 16% (7/45) of the tenofovir disoproxil group, 4% (2/45) of the emtricitabine plus tenofovir disoproxil group, and 14% (3/22) of the entecavir group experienced tolerability failure.
Maltese: Fil-fergħa tal-istudju dwar tenofovir disoproxil, 7% tal-pazjenti waqqfu l-kura minħabba avveniment avvers; 9% tal-pazjenti kellhom żieda kkonfermata fil-krejatinina fis-serum ta' ≥ 0.5 mg/dl jew phosphate fis-serum ikkonfermat ta' < 2 mg/dl sa ġimgħa 48; ma kien hemm l-ebda differenzi statistikament sinifikanti bejn il-fergħat ikkombinati tal-istudju dwar tenofovir u l-fergħa tal-istudju dwar entecavir.
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 ml/min/1.73 m2.
Maltese: Wara tnaqqis inizjali ta' madwar -4.9 ml/min (bl-użu tal-ekwazzjoni Cockcroft-Gault) jew -3.9 ml/min/1.73 m
English: Simulations suggest that the prolonged dose interval using Tenofovir disoproxil Zentiva 245 mg film-coated tablets is not optimal and could result in increased toxicity and possibly inadequate response.
Maltese: Simulazzjonijiet jissuġġerixxu li intervall tad-doża mtawwal bl-użu ta' Tenofovir disoproxil Zentiva 245 mg pilloli miksija b'rita mhuwiex l-aħjar għażla u jista' jirriżulta f'żieda fit-tossiċità u possibbilment f'rispons inadegwat.
English: One tenofovir disoproxil treated subject and no stavudine or zidovudine treated subjects experienced significant (> 4%) lumbar spine BMD loss at week 48.
Maltese: Individwu wieħed li ġie kkurat b'tenofovir disoproxil u ħadd mill-individwi li ġew ikkurati bi stavudine jew zidovudine ma kellhom telf sinifikanti (> 4%) ta' BMD fis-sinsla tad-dahar f'ġimgħa 48.
English: Eight (2%) tenofovir disoproxil 245 mg (treated patients developed the K65R mutation within the first 48 weeks.
Maltese: Tmien pazjenti (2%) li ħadu t-trattament b'245 mg tenofovir disoproxil 245 mg żviluppaw il-mutazzjoni K65R matul l-ewwel 48 ġimgħa.
English: Tenofovir disoproxil phosphate is the phosphate salt of the prodrug tenofovir disoproxil.
Maltese: Tenofovir disoproxil phosphate huwa l-melħ fosfat tal-prodroga tenofovir disoproxil.
English: Tenofovir: AUC: ↔ Cmax: ↑ 42% Cmin: ↔
Maltese: AUC: ↔ Cmax: ↑ 42% Cmin: ↔
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 fillinja bażi, mard tal-HIV avvanzat, jew pazjenti li jkunu qed jirċievu prodotti mediċinali nefrotossiċi fl-istess ħin) għandhom riskju akbar li jkollhom irkupru mhux komplet tal-funzjoni renali minkejja t-twaqqif ta' tenofovir disoproxil (ara sezzjoni 4.4).
English: • That use of Tenofovir disoproxil Zentiva should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Maltese: • Li l-użu ta' Tenofovir disoproxil Zentiva għandu jiġi evitat bl-użu konkomitanti jew riċenti ta' prodotti mediċinali nefrotossiċi.
English: In study GS-US-174-0121, 141 patients with lamivudine resistance substitutions at baseline received tenofovir disoproxil for up to 240 weeks.
Maltese: Fi studju GS-US-174-0121, 141 pazjent b'sostituzzjonijiet tar-reżistenza għal lamivudine fil-linja bażi, irċivew tenofovir disoproxil għal mhux aktar minn 240 ġimgħa.
English: If Tenofovir disoproxil Zentiva is discontinued in patients with chronic hepatitis B with or without HIV co-infection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Maltese: Jekk Tenofovir disoproxil Zentiva jitwaqqaf f'pazjenti b'epatite B kronika infettati jew mhux infettati bl HIV, dawn il-pazjenti għandhom ikunu immonitorjati mill-qrib għal evidenza jekk l-epatite tmur għall-agħar (ara sezzjoni 4.4).
English: e 48 weeks of double-blind tenofovir disoproxil followed by 96 weeks open-label.
Maltese: 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 96 ġimgħa open-label.
English: n 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil .
Maltese: 48 ġimgħa ta' adefovir dipivoxil double-blind segwiti minn 240 ġimgħa ta' tenofovir disoproxil open-label.
English: One hundred forty-one and 139 adult subjects were randomised to a tenofovir disoproxil and emtricitabine plus tenofovir disoproxil treatment arm, respectively.
Maltese: Mija u wieħed u erbgħin u 139 individwu adulti kienu randomised fil-fergħa tal-istudju dwar kura b'tenofovir disoproxil u emtricitabine flimkien ma' tenofovir disoproxil, rispettivament.
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 millgħoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir u atazanavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: The co-primary safety endpoints were discontinuation due to an adverse event and confirmed increase in serum creatinine ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl.
Maltese: Ir-riżultati aħħarin tas-sigurtà ko-primarja kienu t-twaqqif minħabba avveniment avvers u żieda kkonfermata fil-krejatinina fis-serum ta' ≥ 0.5 mg/dl jew phosphate fis-serum ikkonfermat ta' < 2 mg/dl.
English: j 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Maltese: i 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 192 ġimgħa open-label.
English: Thirty-one of the 32 nucleos(t)ide-experienced patients had prior lamivudine experience.
Maltese: Wieħed u tletin mit-32 pazjent li fil-passat ingħataw nucleos(t)ide fil-passat ingħataw lamivudine.
English: In non-proliferating human peripheral blood mononuclear cells (PBMCs) the half-life of tenofovir diphosphate was found to be approximately 50 hours, whereas the half-life in phytohaemagglutinin-stimulated PBMCs was found to be approximately 10 hours.
Maltese: F'ċelluli mononukleari umani tad-demm periferali mhux proliferattivi (PBMCs) il-ħin tenofovir diphosphate jonqos bin-nofs instab li huwa ta' madwar 50 siegħa, filwaqt li l-ħin biex il-livell ta' PBMCs stimulati minn phytohaemagglutinin jonqos binnofs instab li huwa ta' madwar 10 sigħat.
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 millgħoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir u darunavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: The following pack sizes are available: Outer cartons containing 1 bottle of 30 film-coated tablets and 3 bottles of 30 film-coated tablets.
Maltese: Kartun ta' barra li fihom flixkun 1 ta' 30 pillola miksija b'rita u 3 fliexken ta' 30 pillola miksija b'rita.
English: The use of tenofovir disoproxil is not recommended in paediatric patients with renal impairment (see section 4.2).
Maltese: L-użu ta' tenofovir disoproxil mhuwiex rakkomandat f'pazjenti pedjatriċi b'indeboliment renali (ara sezzjoni 4.2).
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil meta użata ma' ledipasvir/sofosbuvir u xi sustanza li ssaħħaħ il-farmakokinetika (e.ż. ritonavir jew cobicistat) ma ġietx stabbilita.
English: Baseline
Maltese: Anzjani
English: • feeling sick (nausea),
Maltese: • uġigħ fl-istonku,
English: Patients with decompensated liver disease: The safety profile of tenofovir disoproxil in patients with decompensated liver disease was assessed in a double-blind active controlled study (GS-US-174-0108) in which adult patients received treatment with tenofovir disoproxil (n = 45) or emtricitabine plus tenofovir disoproxil (n = 45) or entecavir (n = 22) for 48 weeks.
Maltese: Il-profil tas-sigurtà ta' tenofovir disoproxil f'pazjenti b'mard tal-fwied mhux kumpensat kien evalwat fi studju (GS-US-174-0108) double-blind, ikkontrollat b'mod attiv li fih il-pazjenti adulti rċivew kura b'tenofovir disoproxil (n = 45) jew emtricitabine flimkien ma' tenofovir disoproxil (n = 45) jew entecavir (n = 22) għal 48 ġimgħa.
English: NA = Not Applicable a BMD Z-scores not adjusted for height and weight b Primary safety endpoint through week 72
Maltese: Punt aħħari primarju tas-sigurtà matul Ġimgħa 72
English: • dizziness,
Maltese: • uġigħ ta' ras,
English: Tests may also show:
Maltese: Huma disponibbli d-daqsijiet ta' pakketti li ġejjin:
English: What Tenofovir disoproxil Zentiva is and what it is used for What you need to know before you take Tenofovir disoproxil Zentiva How to take Tenofovir disoproxil Zentiva Possible side effects
Maltese: Kif għandek tieħu Tenofovir disoproxil Zentiva Effetti sekondarji possibbli
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Fih lactose monohydrate.
English: Co-administration of Tenofovir disoproxil Zentiva and didanosine is not recommended as this may result in an increased risk of adverse reactions (see section 4.5).
Maltese: L-għoti ta' Tenofovir disoproxil Zentiva flimkien ma' didanosine mhuwiex rakkomandat għax jista' jirriżulta f'żieda fir-riskju ta' reazzjonijiet avversi (ara sezzjoni 4.5).
English: Atazanavir: AUC: ↔ Cmax: ↔ Cmin: ↑ 39%
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↑ 39%
English: Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported (see section 4.4).
Maltese: B'mod rari, ġew irrappurtati pankreatite u aċidożi lattika li kultant kienu fatali (ara sezzjoni 4.4).
English: i 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label, j 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil .
Maltese: 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 192 ġimgħa open-label.
English: Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs).
Maltese: Il-ħin biex il-livell ta' tenofovir diphosphate jonqos bin-nofs huwa ta' 10 sigħat ġewwa ċ-ċellula f'celluli mononukleari tad-demm periferali (peripheral blood mononuclear cells, PBMCs) attivati u 50 siegħa f'dawk li qed jistrieħu.
English: This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV infection or both.
Maltese: Din is-sustanza attiva hi mediċina antiretrovirali jew antivirali li tintuża biex tittratta l-infezzjoni tal-HIV jew tal-HBV jew it-tnejn.
English: - aminoglycosides, pentamidine or vancomycin (for bacterial infection) - amphotericin B (for fungal infection)
Maltese: • Mediċini oħra li fihom didanosine (għall-infezzjoni bl-HIV):
English: Tenofovir disoproxil should not be administered concurrently with adefovir dipivoxil (see section 4.4).
Maltese: Mhux rakkomandat li tenofovir disoproxil jingħata flimkien ma' didanosine (ara sezzjoni 4.4).
English: Both treatments produced similar results with regard to histological response (defined as Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis) at week 48 (see Table 3 below).
Maltese: Iż-żewġ trattamenti pproduċew riżultati simili fir-rigward ta' rispons istoloġiku (definitbħala titjib fil-punteġġ nekroinfjammatorju ta' Knodell ta' mill-inqas 2 punti mingħajr ma marret għall-agħar il-fibrożi ta' Knodell) f'ġimgħa 48 (ara Tabella 3 hawn taħt).
English: Musculoskeletal and connective tissue disorders: Uncommon:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi:
English: The distribution of HBV genotypes at baseline was similar between the TDF and Placebo groups.
Maltese: Id-distribuzzjoni tal-ġenotipi talHBV fil-linja bażi kienet simili bejn il-grupp ta' TDF u tal-Plaċebo.
English: A decreased dosage of 250 mg didanosine co-administered 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' falliment viroloġiku f'diversi kumbinazzjonijiet li kienu ttestjati għat-trattament ta' infezzjoni bl-HIV-1.
English: • HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
Maltese: • Adolexxenti infettati bl-HIV-1 li għandhom minn 12 sa inqas minn 18-il sena li jiżnu mill-inqas 35 kg u li diġà ġew ikkurati fil-passat b'mediċini oħra kontra
English: Haemodialysis patients: 245 mg tenofovir disoproxil may be administered every 7 days following completion of a haemodialysis session*.
Maltese: Pazjenti fuq id-dijaliżi tad-demm: 245 mg ta' tenofovir disoproxil jistgħu jingħataw kull 7 ijiem wara li tintemm sessjoni ta' dijaliżi tad-demm*.
English: • pancreas problems.
Maltese: • problemi fil-fwied.
English: Table 6: Histological response (%) in compensated HBeAg negative and HBeAg positive subjects at week 240 compared to baseline
Maltese: Tabella 6: Rispons istoloġiku (%) f'individwi li kienu negattivi għal HBeAg kumpensat u pożittivi għal HBeAg kumpensat f'ġimgħa 240 meta mqabbla mal-linja bażi
English: Cmax: ↑ 68%
Maltese: AUC: ↔ Cmax: ↑ 38%
English: Fifty-four patients (including 2 patients with lamivudine resistance mutations at baseline) initially received blinded placebo treatment for 72 weeks, and 52/54 patients followed with tenofovir disoproxil (PLB-tenofovir disoproxil group).
Maltese: Erbgħa u ħamsin pazjent (inkluż 2 pazjenti b'mutazzjonijiet ta' reżistenza għal lamivudine fillinja bażi) fil-bidu rċivew kura bi plaċebo blinded għal 72 ġimgħa, u 52/54 pazjent segwew b'tenofovir disoproxil (il-grupp PLB-tenofovir disoproxil).
English: In study GS-US-174-0108, 45 patients (including 9 patients with lamivudine and/or adefovir dipivoxil resistance mutations at baseline) received tenofovir disoproxil for up to 168 weeks.
Maltese: Fi studju GS-US-174-0108, 45 pazjent (li jinkludu 9 pazjenti b'mutazzjonijiet reżistenti għal lamivudine u/jew adefovir dipivoxil fil-linja bażi) irċivew tenofovir disoproxil għal mhux aktar minn 168 ġimgħa.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant cap and induction heat sealing (with aluminium foil).
Maltese: Flixkun tal-polyethylene ta' densità għolja (HDPE - high density polyethylene) b'għatu tal- polyethylene li ma jistgħux jiftħuħ it-tfal u siġill imwaħħal permezz ta' induzzjoni ta' sħana (b'fojl tal-aluminju).
English: Atazanavir: AUC: ↔ Cmax: ↔ Cmin: ↑ 63%
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↑ 63%
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta milgħoti fl-istess ħin ta' tenofovir disoproxil, ledipasvir/sofosbuvir u atazanavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Whole body mean (SD) BMD Z-scorea Whole body mean (SD) change from baseline BMD Z-scorea
Maltese: Bidla medja (SD) mill-punteġġ Z BMD tal-linja bażi tal-ġisem kollua
English: If serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil 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-phosphate fis-serum ikun ikkonfermat li hu < 3.0 mg/dl (0.96 mmol/l) fi kwalunkwe pazjent pedjatriku li jkun qed jirċievi tenofovir disoproxil, il-funzjoni renali għandha tkun evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl talkonċentrazzjonijiet tal-glucose fid-demm, tal-potassium fid-demm u tal-glucose fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: In study GS-US-174-0103 a significantly greater proportion of patients in the tenofovir disoproxil group than in the adefovir dipivoxil group had normalised ALT and achieved HBsAg loss at week 48 (see Table 3 below).
Maltese: Fi studju GS US 174 0103, proporzjon akbar b'mod sinifikanti ta' pazjenti fil-grupp ta' tenofovir disoproxil milli fil-grupp ta' adefovir dipivoxil, kellu ALT normalizzat u kiseb tnaqqis ta' HBsAg f'ġimgħa 48 (ara Tabella 3 hawn taħt).
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta millgħoti fl-istess ħin ta' tenofovir disoproxil sofosbuvir/velpatasvir u lopinavir /ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: As a general rule, it is recommended that HIV and HBV infected women do not breast-feed their infants in order to avoid transmission of HIV and HBV to the infant.
Maltese: Bħala regola ġenerali, huwa rakkomandat li nisa infettati bl-HIV u bl-HBV ma jreddgħux lit-trabi tagħhom sabiex jevitaw li jgħaddu l-HIV u l-HBV lit-tarbija.
English: See also section 4.8.
Maltese: Ara wkoll sezzjoni 4.8.
English: MedDRA system organ class
Maltese: Sistema talklassifika talorgani MedDRA
English: USV Private Limited D-115, TTC Industrial Area, Shirvane Navi Mumbai - 400706, Maharashtra, INDIA
Maltese: USV Private Limited D-115, TTC Industrial Area, Shirvane, Navi Mumbai-400706, Maharashtra, L-Indja
English: Κορίνθου 12, Ν. Ψυχικό, Ελλάδα τηλ 210 6776550-1
Maltese: Ψυχικό, Ελλάδα τηλ 210 6776550-1
English: INFORMATION IN BRAILLE Grasustek 6 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Grasustek 6 mg
English: (≥ 1/100 to < 1/10)
Maltese: Komuni (≥1/1,00 sa <1/10)
English: − The active substance is pegfilgrastim.
Maltese: − Is-sustanza attiva hi pegfilgrastim.
English: Store in a refrigerator (2 °C-8 °C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: 4.1 Therapeutic indications
Maltese: 4.3 Kontraindikazzjonijiet
English: The concentration is 10 mg/ml based on protein only**.
Maltese: Il-konċentrazzjoni hi 10 mg/ml abbażi ta' proteina biss**.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1
English: Very rare
Maltese: Rari sa <
English: Nervous system Disorders
Maltese: Disturbi fissistema nervuża
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factors; ATC Code: L03AA13.
Maltese: Kategorija farmakoterapewtika: immunostimulanti, fatturi li jistimulaw il-kolonja; Kodiċi ATC:
English: Grasustek contains the active substance pegfilgrastim.
Maltese: Grasustek fih is-sustanza attiva pegfilgrastim.
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Maltese: Pegfilgrastim huwa konjugat kovalenti ta' G-CSF (r-metiHuG-CSF) rikombinanti uman b'molekula unika ta' 20 kd polyethylene glycol.
English: Excipients: Sorbitol (E420), polysorbate 20, sodium acetate, water for injections.
Maltese: Eċċipjenti: Sorbitol (E420), polysorbate 20, sodium acetate, ilma għall-injezzjonijiet.
English: PHARMACEUTICAL PARTICULARS
Maltese: PHARMACEUTICAL FORM
English: Alvogen Romania SRL 44B, Theodor Pallady Blvd. 3rd district, 032266
Maltese: Alvogen Romania SRL 44B, Theodor Pallady Blvd.
English: Tabulated list of adverse reactions
Maltese: Elenku tabellat ta' reazzjonijiet avversi
English: Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Maltese: Respiratorju Akut Reazzjonijiet pulmonari avversi (pnewmonja interstizzjali, edema pulmonari, infiltrati pulmonari u fibrożi pulmonari) Emoptisi
English: Av. V. Holjevca 40 , 10000 Zagreb, Hrvatska Tel:+385 1 6641 830
Maltese: Zagreb, Hrvatska Tel:+385 1 6641 830
English: *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Maltese: *Sodium acetate jiġi fformat b'tittrazzjoni ta' aċidu aċetiku glaċjali b'sodium hydroxide.
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/l) have been reported (see section 4.4).
Maltese: Każijiet komuni ta' lewkoċitosi (Għadd ta' Ċelluli Bojod tad-Demm [WBC] > 100 x 109/l) ġew rapportati (ara sezzjoni 4.4).
English: 13, 24941 Flensburg, Germany
Maltese: 13, 24941 Flensburg, Il-Ġermanja
English: years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg·hr/ml and 29.3 ± 23.2 μg·hr/ml, respectively) (see section 5.1).
Maltese: Il-grupp tal-iżgħar età (0-5 snin) kellu esponiment medju ogħla ta' pegfilgrastim (AUC) (± Devjazzjoni Standard) (47.9 ± 22.5 μg·hr/ml) minn tfal akbar fl-età ta' 6-11-il sena u 12-21 sena (22.0 ± 13.1 μg·hr/ml u 29.3 ± 23.2 μg·hr/ml, rispettivament) (ara sezzjoni 5.1).
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: • bleeding from the lung (pulmonary haemorrhage)
Maltese: • emorraġija fil-pulmun (emorraġija pulmonari)
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Maltese: Il-kategorija ta' frekwenza kienet stmata minn kalkolazzjoni statistika abbażi ta' 1,576 pazjent li rċevew pegfilgrastim f'disa' provi kliniċi każwali.
English: Step 3: Inject
Maltese: Stadju 3 Injetta
English: Sweet's syndrome (acute febrile dermatosis)1,2;
Maltese: Sindrome ta' Sweet (dermatosi akuta bid-deni)
English: The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Maltese: Is-sigurtà u effikaċja tal-għoti ta' pegfilgrastim f'pazjent b'AML de novo ta' < 55 sena b'ċitoġenetiċi t(15;17) ma ġewx stabbiliti.
English: OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Maltese: Reazzjonijiet fis-sit t'injezzjoni, li jinkludu eritema fis-sit t'injezzjoni (mhux komuni) kif ukoll uġigħ fissit t'injezzjoni (każijiet komuni) seħħew fil-bidu tat-trattament jew fi trattament sussegwenti bi pegfilgrastim.
English: • breathing problems.
Maltese: • problemi bin-nifs.