FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-medication with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Maltese: L-għoti flimkien ma' indutturi talenzimi UGT għandu jiġi evitat minħabba r-riskju potenzjali ta' tnaqqis fl-effikaċja.
English: 4 LOCF, values after antihypertensive rescue censored
Maltese: 3 LOCF, valuri wara salvataġġ minn pressjoni għolja ċċensurati
English: ** p-value <0.001
Maltese: ** valur p <0.
English: The mechanism of action of empagliflozin is independent of beta cell function and insulin pathway and this contributes to a low risk of hypoglycaemia.
Maltese: Il mekkaniżmu ta' azzjoni ta' empagliflozin huwa indipendenti mill-funzjoni taċ-ċelluli beta u r-rotta talinsulina u dan jikkontribwixxi għal riskju baxx ta' ipogliċemija.
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, infermiera, jew lill-ispiżjar tiegħek.
English: The efficacy and safety of empagliflozin as add on to basal insulin with or without metformin and/or a sulphonylurea was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration.
Maltese: L-effikaċja u s-sigurtà ta' empagliflozin bħala terapija addizzjonali għal insulina bażali bi jew mingħajr terapija b'metformin u/jew sulphonylurea ġew evalwati fi studju double blind ikkontrollat bi plaċebo li dam 78 ġimgħa.
English: Бьорингер Ингелхайм РЦВ ГмбХ и Ко.
Maltese: Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГклон България
English: Increased urination (including the predefined terms pollakiuria, polyuria, and nocturia) was observed at higher frequencies in patients treated with empagliflozin (empagliflozin 10 mg: 3.4%, empagliflozin 25 mg: 3.2%) compared to placebo (1.0%).
Maltese: Żieda fil-mgħodija tal-awrina Żieda fil-mgħodija tal-awrrina (li jinkludi t-termini mfissra minn qabel ta' pollakijurja, polijurja u nokturja) kienu osservati bi frekwenza ogħla f'pazjenti trattati b'empagliflozin (empagliflozin 10 mg: 3.4%, empagliflozin 25 mg: 3.2%) meta mqabbel ma' plaċebo (1.0%).
English: • itching
Maltese: • ħakk
English: Effects of empagliflozin on other medicinal products Based on in vitro studies, empagliflozin does not inhibit, inactivate, or induce CYP450 isoforms.
Maltese: Effetti ta' empagliflozin fuq prodotti mediċinali oħrajn Mill-istudji in vitro, empagliflozin ma jimpedixxix, jinattivax, jew jinduċi isoformi ta' CYP450.
English: Initiation of empagliflozin therapy in this population is not recommended (see section 4.2).
Maltese: deidratazzjoni u pressjoni baxxa (ara sezzjoni 4.4).
English: a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy 1 Mean adjusted for baseline value
Maltese: a Sett ta' analiżi sħiħa (FAS - Full analysis set) fejn intużat l-aħħar osservazzjoni li ġiet imexxija 'l quddiem (LOCF - Last observation carried forward) qabel l-għoti ta' terapija għal salvataġġ gliċemiku.
English: In patients tolerating empagliflozin whose eGFR is persistently below 60 ml/min/1.73 m2 or CrCl <60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily.
Maltese: F'pazjenti li jittolleraw empagliflozin li għandhom eGFR b'mod persistenti taħt 60 ml/min/1.73 m2 jew CrCl taħt 60 ml/min, id-doża ta' empagliflozin għandha tiġi aġġustata jew tinżamm f'ammont ta' 10 mg darba kuljum.
English: In male rats, treatment-related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26-times the maximal clinical exposure to empagliflozin.
Maltese: F'firien irġiel, ġrieħi proliferattivi vaskulari beninni marbuta mat-trattament (emanġjomas) tal-għenqud limfatiku mesenteriku kienu osservati fl-ogħla dożi, imma mhux f'doża ta' 300 mg/kg/jum, li tikkorispondi għal madwar 26 darba l-esponimet kliniku massimu ta' empagliflozin.
English: Based on the mode of action of SGLT-2 inhibitors, osmotic diuresis accompanying therapeutic glucosuria may lead to a modest decrease in blood pressure (see section 5.1).
Maltese: Abbażi tal-mod ta' azzjoni tal-impedituri ta' SGLT-2, dijuresi osmotika li takkompanja glukosurja terapewtika tista' twassal għal tnaqqis modest fil-pressjoni tad-demm (ara sezzjoni 5.1).
English: Empagliflozin induced renal tumours in male mice at 1000 mg/kg/day, but not at 300 mg/kg/day, which corresponds to approximately 11-times the maximal clinical exposure to empagliflozin.
Maltese: 300 mg/kg/jum, li tikkorispondi għal madwar 11-il darba l-esponimet kliniku massimu ta' empagliflozin.
English: Empagliflozin does not inhibit P-gp at therapeutic doses.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Interazzjonijiet farmakodinamiċi
English: Volume depletiona
Maltese: Indeboliment tal-fwied
English: In patients with mild, moderate or severe renal impairment (eGFR <30 - <90 ml/min/1.73 m2) and patients with kidney failure/end stage renal disease (ESRD), AUC of empagliflozin increased by approximately 18%, 20%, 66%, and 48%, respectively compared to subjects with normal renal function.
Maltese: AUC ta' empagliflozin żdied b'madwar 18%, 20%, 66% u 48%, rispettivament meta mqabbel ma' individwi b'funzjoni tal-kliewi normali.
English: (95% CI) a Full analysis set (FAS)
Maltese: a Sett ta' analiżi sħiħa (FAS)
English: Monitoring of renal function
Maltese: MANIFATTUR RESPONSABBLI
English: Minor hypoglycaemia
Maltese: Ipogliċemija minuri
English: Patients aged 75 years and older may be at an increased risk of volume depletion.
Maltese: Pazjenti li għandhom 75 sena jew aktar jistgħu jkunu f'riskju akbar ta' żvojtjar ta' volum.
English: FPG of -20.5 mg/dl [-1.14 mmol/l] for empagliflozin 10 mg and -23.2 mg/dl [-1.29 mmol/l] for empagliflozin 25 mg compared to placebo (7.4 mg/dl [0.41 mmol/l]).
Maltese: F'erba' studji bil-plaċebo bħala kontroll, it-trattament b'empagliflozin bħala monoterapija jew terapija addizzjonali għal ma' metformin, pioglitazone, jew metformin flimkien ma' sulfonylurea irriżulta f'bidliet medji mil-linja bażi fl-FPG ta' -20.5 mg/dl [-1.14 mmol/L] għal empagliflozin 10 mg u23.2 mg/dl [-1.29 mmol/L] għal empagliflozin 25 mg meta mqabbla mal-plaċebo (7.4 mg/dl [0.
English: In a 2 year carcinogenicity study, empagliflozin did not increase the incidence of tumours in female rats up to the highest dose of 700 mg/kg/day, which corresponds to approximately 72-times the maximal clinical AUC exposure to empagliflozin.
Maltese: Fi studju li dam sejjer sentejn dwar il-karċinoġeniċità, empagliflozin ma żiedx l-inċidenza ta' tumuri f'firien nisa sal-ogħla doża ta' 700 mg/kg/jum, li jikkorispondi għal madwar 72 darba l-esponiment AUC massimu kliniku t'empagliflozin.
English: In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32 times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin (equivalent to 4 times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity.
Maltese: Fi studji kliniċi b'kontroll dożi waħdenin ta' sa 800 mg empagliflozin (ekwivalenti għal 32 darba logħla doża rakkomandata għal kuljum) f'voluntieri b'saħħithom u dożi multipli ta' kuljum ta' sa 100 mg empagliflozin (ekwivalenti għal 4 darbiet l-ogħla doża rakkomandata għal kuljum) f'pazjenti b'dijabete ta' tip 2 ma wrew l-ebda tossiċità.
English: * p-value <0.0001
Maltese: 0001 ** valur p <0.
English: Fasting plasma glucose
Maltese: Colloidal anhydrous silica Magnesium stearate
English: Jardiance 25 mg film-coated tablets are oval, pale yellow and biconvex.
Maltese: Jardiance 25 mg pilloli miksija b'rita huma ovali safranin ċari u mżaqqin fuq żewġ naħat.
English: At Week 52, treatment with empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared with placebo and a reduction in FPG and body weight.
Maltese: Fil-Ġimgħa 52, it-trattament b'empagliflozin irriżulta fi tnaqqis statistikament sinifikanti f'HbA1c u għajnuna għall-insulina meta mqabbel ma' plaċebo u tnaqqis fl-FPG u l-piż tal-ġisem.
English: N HbA1c (%) at week 18 Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N HbA1c (%) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Basal insulin dose (IU/day) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) a Full analysis set (FAS) - Completers using last observation carried forward (LOCF) prior to glycaemic rescue therapy 1 mean adjusted for baseline value * p-value <0.0001 ** p-value <0.025
Maltese: Total ta' 13,076 pazjent b'dijabete ta' tip 2 kienu inklużi fl-istudji kliniċi sabiex tiġi evalwata s-sigurtà ta' empagliflozin. 2,856 pazjent irċevew empagliflozin 10 mg u 3,738 pazjent irċevew empagliflozin
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss fil-valuri tal-glukożju fid-demm, inqas minn 14 mmol/l (250 mg/dl).
English: Table 2: Efficacy results of a 24 week placebo-controlled study of empagliflozin as monotherapya
Maltese: Tabella 2: Riżultati ta' effikaċja għal empagliflozin bħala monoterapija fi studju ta' 24 ġimgħa kkontrolat bi plaċeboa
English: Hypoglycaemia The frequency of hypoglycaemia depended on the background therapy in the respective studies.
Maltese: Ipogliċemija Il-frekwenza ta' ipogliċemija kienet tiddependi fuq it-terapija fl-isfond fl-istudji rispettivi.
English: • fever (≥38°C)
Maltese: • deni (≥38°C)
English: 20 micrograms
Maltese: 20 mikrogrammi
English: 50 micrograms
Maltese: 50 mikrogrammi
English: Control (N = 7,305)
Maltese: Kontroll (N = 7,305)
English: Control
Maltese: Kontroll
English: Cervarix Control
Maltese: Cervarix Kontroll
English: B-1330 Rixensart, Belgium
Maltese: B-1330 Rixensart, Il-Belġju
English: Frequency Adverse reactions
Maltese: Frekwenza Reazzjonijiet avversi
English: Sodium chloride (NaCl)
Maltese: Sodium chloride (NaC1)
English: Evidence of Anamnestic (Immune Memory) Response
Maltese: Evidenza ta' Rispons Anamnestiku (Memorja Immuni)
English: Control (N = 8,708)
Maltese: Kontroll (N = 8,708)
English: 0.5 milligrams Al3+ in total
Maltese: total ta' 0.5 milligrammi Al3+
English: Date of latest renewal: 17 September 2012.
Maltese: Data tal-aħħar tiġdid: 17 Settembru 2012
English: % Efficacy (95% CI)
Maltese: % Effikaċja (95% CI)
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100)
Maltese: Komuni (≥1/100 sa <1/10) Mhux komuni (≥1/1,000 sa <1/100)
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut BE-1330 Rixensart Belgium
Maltese: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut BE-1330 Rixensart
English: Pharmacotherapeutic group: Vaccines, Papillomavirus vaccines, ATC code: J07BM02
Maltese: Vaccini, Vaċċini għal Papillomavirus, kodiċi ATC: J07BM02
English: Immunogenicity in males was assessed in 2 clinical trials HPV-011 (N=173) and HPV-040 (N=556).
Maltese: L-immunoġeniċità fl-irġiel ġiet ivvalutata f'2 provi kliniċi HPV-011 (N=173) u HPV-040 (N=556).
English: Itching/pruritus, rash, urticaria
Maltese: Ħakk/prurite, raxx, urtikarja
English: BATCH NUMBER LOT:
Maltese: NUMRU TAL-LOTT LOTT:
English: 5 years.
Maltese: 5 snin
English: The phase II trial (study 001/007) enrolled only women who: - Were tested negative for oncogenic HPV DNA of types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56,
Maltese: - Kellhom riżultat negattiv għat-test għal HPV DNA onkoġeniku ta' tipi 16, 18, 31, 33, 35, 39,
English: Use with hormonal contraceptive
Maltese: Użu ma' kontraċettiv ormonali
English: The TVC may approximate to the general population of women in the age range of 15-25 years.
Maltese: TVC jista' jqarreb il-popolazzjoni ġenerali ta' nisa fil-medda ta' etajiet bejn 15-25 sena.
English: % Efficacy (96.2% CI)
Maltese: (96.2 % CI)
English: Paediatric population (children < 9 years of age)
Maltese: Popolazzjoni pedjatrika (tfal < l-età ta' 9 snin)
English: Belgique/België/Belgien
Maltese: Suomi/Finland
English: Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections
Maltese: Sodium dihydrogen phosphate dihydrate (NaH2PO4
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskulo-skeltriċi u tattessuti konnettivi
English: Sodium dihydrogen phosphate dihydrate Water for injections
Maltese: Sodium dihydrogen phosphate dihydrate Ilma għall-injezzjonijiet
English: Clinical efficacy in women aged 15 to 25 years
Maltese: Effikaċja klinika f'nisa b'età minn 15 sa 25 sena
English: Of these subjects, 100% (95% CI: 96.1;100) remained seropositive for HPV-16 and HPV-18 in the ELISA assay.
Maltese: Minn dawn l-individwi, 100% (95% CI: 96.1;100) baqgħu seropożittivi għal HPV-16 u HPV-18 fl-analiżi ELISA.
English: 1 adjuvanted by AS04 containing: 3-O-desacyl-4'- monophosphoryl lipid A (MPL)2
Maltese: 3-O-desacyl-4'- monophosphoryl lipid A (MPL)2
English: The efficacy results at the event-triggered analysis were 94.3% (96.1% CI: 91.5;96.3) against 6-month persistent infection and 91.4% (96.1% CI: 89.4;95.4) against 12-month persistent infection.
Maltese: 3% (96.1% CI:91.5;96.3) kontra infezzjoni persistenti għal 6 xhur u 91.4% (96.1% CI: 89.4;95.4) kontra infezzjoni persistenti għal 12
English: In clinical studies, approximately 60% of women who received Cervarix used hormonal contraceptives.
Maltese: Fi studji kliniċi, madwar 60% ta' nisa li jkunu ħadu Cervarix użaw kontraċettivi ta' l-ormoni.
English: Cervarix is a turbid white suspension.
Maltese: Cervarix hu suspensjoni bajda u mdardra.
English: Gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
Maltese: Sintomi gastro-intestinali inklużi dardir, remettar, dijareja u wġigħ addominali
English: Deutschland GlaxoSmithKline GmbH & Co. KG
Maltese: GlaxoSmithKline GmbH & Co.
English: Immunogenicity in males aged 10 to 18 years
Maltese: Immunoġeniċità f'irġiel b'età minn 10 snin sa 18-il sena
English: 2adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
Maltese: 2adsorbit fuq aluminium hydroxide, idratat, (Al(OH)3)
English: 3adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
Maltese: 3adsorbit fuq aluminium hydroxide, idratat, (Al(OH)3)
English: Tel: + 49 (0)89 360448701 produkt.info@gsk.com
Maltese: KG Tel: + 49 (0)89 360448701 produkt.info@gsk.com
English: Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Maltese: Vaċċin Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħaħ, adsorbit)
English: At the end of study analysis, Cervarix reduced definitive cervical therapy procedures (includes loop electrosurgical excision procedure [LEEP], cold-knife Cone, and laser procedures) by 70.2% (95% CI: 57.8;79.3) in TVC-naïve and 33.2% (95% CI: 20.8;43.7) in TVC.
Maltese: Fl-analiżi fl-aħħar tal-istudju, Cervarix naqqas proċeduri definittivi ta' terapija għall-għonq tal-utru (fosthom il-proċedura ta' loop electrosurgical excision [LEEP], cold-knife Cone, u proċeduri billejżer) b'70.2% (95% CI: 57.8;79.3) f'dawk ġodda għal TVC u b'33.2% (95% CI: 20.
English: Cervarix may also be administered concomitantly with meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT); with combined hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (Twinrix) or with hepatitis B (rDNA) vaccine (Engerix B).
Maltese: Cervarix jista' wkoll jingħata flimkien ma' vaċċin konjugat tat-tossojde tat-tetnu tas-serogruppi meningokokkali A, C, W-135, Y (MenACWY-TT); vaċċin li fih taħlita tal-epatite A (inattivat) u l epatite B (rDNA) (Twinrix) jew ma' vaċċin tal-epatite B (rDNA) (Engerix B).
English: HPV type
Maltese: Tip ta' HPV
English: LIST OF EXCIPIENTS Sodium chloride
Maltese: Sodium chloride
English: Pack sizes of 1, 10 and 100 vials.
Maltese: Daqsijiet tal-pakkett ta' 1, 10 u 100 kunjetti.
English: Immunogenicity in HIV infected women
Maltese: Immunoġeniċità f'nisa infettati bl-HIV
English: For storage after first opening, see section 6.3.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara s-sezzjoni 6.1.
English: At the event-triggered analysis the efficacy was 92.9% (96.1% CI: 79.9;98.3) against CIN2+ and 80%
Maltese: Fl-analiżi attivata minn avveniment l-effikaċja kienet 92.9% (96.1% CI: 79.9;98.3) kontra CIN2+ u 80% (96.1% CI: 0.3;98.1) kontra CIN3+.
English: Table 7 - Vaccine efficacy at study conclusion in study HPV-015 Endpoint
Maltese: Tabella 7 - L-effikaċja tat-tilqim fil-konklużjoni tal-istudju fi studju HPV-015 Endpoint
English: In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/18 infection was 100% (95% CI: 80.5; 100).
Maltese: Fi studju 007 l-effikaċja ta' Cervarix kontra infezzjoni persistenti ta' 12 il-xahar b'HPV-16/18 kienet ta' 100% (95% CI: 80.
English: Human Papillomavirus1 type 16 L1 protein2,3,4
Maltese: Papillomavirus Uman1 tat-tip 16 LI2,3,4
English: (96.1% CI: 0.3;98.1) against CIN3+.
Maltese: 1% (96.1% CI: 83.4;98.5).
English: Cervarix is an adjuvanted non-infectious recombinant vaccine prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein of oncogenic HPV types 16 and 18.
Maltese: Cervarix hu vaċċin awżiljat, rikombinanti mhux infettiv magħmul mill-partiċelli qishom virus (VLPs) ippurifikati ħafna tal-proteina maġġuri capsid L1 tat-tipi onkoġeniċi HPV 16 u 18.
English: • itching, red skin rash, hives (urticaria)
Maltese: • ħakk, raxx u ħmura fil-ġilda, hives (urtikarja)
English: In study HPV-020, conducted in South Africa, 22 HIV uninfected and 42 HIV infected subjects (WHO clinical stage 1; ATP cohort for immunogenicity) received Cervarix.
Maltese: Fl-istudju HPV-020, li sar fl-Afrika ta' Isfel, 22 individwu mhux infettati bl-HIV u 42 infettati bl-HIV
English: • upper respiratory tract infection (infection of the nose, throat or trachea)
Maltese: • infezzjoni fl-apparat respiratorju tan-naħa ta' fuq (infezzjoni ta' l-imnieħer, griżmejn jew trakea)
English: The primary efficacy endpoint was CIN2+ associated with HPV-16 and/or HPV-18 (HPV-16/18).
Maltese: L-endpoint ta' effikaċja primarja kien CIN2+ assoċjat ma' HPV-16 u/jew HPV-18 (HPV-16/18).
English: Human Papillomavirus1 type 18 L1 protein2,3,4
Maltese: Papillomavirus Uman1 tat-tip 18 LI2,3,4
English: Serological data suggest a transfer of anti-HPV-16 and anti-HPV-18 antibodies via the milk during the lactation period in rats.
Maltese: Informazzjoni seroloġika turi transfer ta' anti-korpi anti-HPV-16 u anti-HPV-18 mill-ħalib waqt il perjodu ta' treddigħ fil-firien.
English: Tel.: + 48 (22) 576 9000
Maltese: GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9000
English: HPV-31, 33 and 45 showed consistent cross-protection for 6-month persistent infection and CIN2+ endpoints in all study cohorts.
Maltese: HPV-31, 33 u 45 urew protezzjoni inkroċjata konsistenti għall-endpoints ta' infezzjoni persistenti għal
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°Ċ - 8°Ċ).
English: In study HPV-023, subjects from the Brazilian cohort (N=437) of study 001/007 were followed up to a mean of 8.9 years (standard deviation 0.4 years) after the first dose.
Maltese: Fl-istudju HPV-023, individwi mill-koort Brażiljan (N = 437) ta' studju 001/007 kienu segwiti għal medja ta' 8.9 snin (devjazzjoni standard 0.4 snin) wara l-ewwel doża.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: HPV type 16 L1 protein1,2
Maltese: Proteina HPV tat-tip 16 LI1,2
English: 0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl).
Maltese: 0.5 ml suspensjoni f'kunjett (tip I tal-ħġieġ) għal doża 1 b'tapp (butyl rubber).
English: Women (N=1,113) were vaccinated in study 001 and evaluated for efficacy up to month 27.
Maltese: Nisa (N=1,113) kienu vaċċinati fi studju 001 u evalwati għall-effikaċja sa xahar 27.
English: 1Human Papillomavirus = HPV 2adjuvanted by AS04 containing:
Maltese: 1Papillomavirus Uman = HPV
English: Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur GlaxoSmithKline Biologicals s.a.
English: Other medicines and Cervarix
Maltese: Mediċini oħra u Cervarix
English: HPV type 18 L1 protein1,2
Maltese: Proteina HPV tat-tip 18 LI1,2
English: Ten years after administration of the first dose, 100% of subjects in the 15-25 years group, 99.2% in the 26-45 years group and 96.3% in the 46-55 years group were still seropositive for HPV-16, and 99.2%, 93.7% and 83.8% for HPV-18, respectively.
Maltese: Għaxar snin wara l-għoti talewwel doża, 100 % tal-individwi fil-grupp ta' 15-25 sena, 99.2 % fil-grupp ta' 26-45 sena u 96.3 % fil-grupp ta' 46-55 sena xorta kienu seropożittivi għal HPV-16, u 99.2 %, 93.7 % u 83.8 % għal HPV18, rispettivament.
English: See sections 4.4 and 5.1 for important information on the data that support this indication.
Maltese: Ara sezzjonijiet 4.4 u 5.1 għal tagħrif importanti dwar dejta li ssostni din l-indikazzjoni.
English: If you are between 9 and 14 years old
Maltese: 9 sa 14-il sena.
English: Vaccine efficacy against CIN1+ associated with HPV 16/18 observed in the ATP cohort was 91.7% (96.1% CI: 82.4;96.7).
Maltese: L-effikaċja tat-tilqima kontra CIN1+ marbut ma' HPV 16/18 osservat fil-grupp ATP kienet ta' 91.7% (96.1% CI: 82.4;96.7).
English: Clinical studies
Maltese: Provi kliniċi
English: Cervarix is available in 2 dose vials (1 ml) in packs of 1, 10 and 100.
Maltese: Cervarix tista' ssibu f'kunjetti ta' 2 dożi (1 ml) f'kaxxi ta' 1, 10 u 100.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2007.
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Settembru 2007.
English: In a pooled analysis (HPV-029,-30 & -48), 99.7% and 100% of females aged 9 years seroconverted to HPV types 16 and 18, respectively after the third dose (at month 7) with GMTs at least 1.4-fold and 2.4-fold higher as compared to females aged 10-14 years and 15 to 25 years, respectively.
Maltese: F'analiżi miġbura (HPV-029,-30 & -48), 99.7% u 100% ta' nisa b'età ta' 9 snin kellhom serokonverżjoni għal tipi ta' HPV 16 u 18, rispettivament wara t-tielet doża (fis-7 xahar) b'GMTs mill-inqas 1.4 darbiet u 2.4 darbiet ogħla meta mqabbla ma' nisa b'età ta' 10-14-il sena u 15 sa 25 sena, rispettivament.
English: Bridging of clinical efficacy against anal lesions and cancers
Maltese: Estrapolazzjoni tal-effikaċja klinika kontra l-leżjonijiet u kanċer anali
English: 6.2 Incompatibilities
Maltese: l-immunità kontra
English: In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.
Maltese: F-sub grupp sekondarju ta' suġġetti definit minn qabel (Cervarix = 8, 130 kontra kontroll = 5,786) eventi avversi ġew segwiti għal 30 ġurnata wara kull tilqima.
English: 470 subjects (142 aged 15-25 years, 172 aged 26-45 years and 156 aged 46-55 years) who completed study HPV-014 and received the 3 dose schedule were followed-up for up to 10 years in the extension study HPV-060.
Maltese: kienu anqas f'nisa ta' il-fuq minn 25 sena. 470 individwu (142 b'età ta' 15-25 sena, 172 b'età ta' 2645 sena u 156 b'età ta' 46-55 sena) li lestew l-istudju HPV-014 u li rċevew l-iskeda ta' 3 dożi kienu segwiti għal massimu ta' 10 snin fl-istudju ta' estensjoni HPV-060.
English: PHARMACEUTICAL FORM Suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni.
English: Efficacy against ≥ASC-US (abnormal cytology) associated with oncogenic non-vaccine types was 37.2% (96.2% CI [21.3; 50.1]) (ATP).
Maltese: Tinkludi 15 % tal individwi bi storja preċedenti ta' marda/infezzjoni ta' HPV L-effikaċja kontra ≥ASC-US (ċitoloġija anormali) assoċjata ma' tipi mhux tal-vaċċin onkoġeniċi kienet ta' 37.2 % (96.2 % CI [21.3; 50.1]) (ATP).