FrancophonIA/ELRC3.0 huggingface dataset:
English: • general aches and pains in the joints and muscles.
Maltese: • uġigħ ġenerali u uġigħ fil-ġogi u fil-muskoli.
English: Used plunger
Maltese: Planġer użat
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Maltese: Il-potenzjal ta' interazzjoni ma' lithium, li wkoll jippromwovi ir-reħa ta' newtrofili, ma ġiex investigat speċifikament.
English: See leaflet for further information.
Maltese: Sorsi oħrajn ta' informazzjoni
English: The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Maltese: L-għatu tal-labra tas-siringa mimlija għal-lest fih lastiku naturali niexef (derivattiv tal-latex), li jista' jikkawza reazzjonijiet allerġiċi.
English: Neulasta may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Maltese: Neulasta jista' jiġi espost għal temperatura ambjentali (mhux aktar minn 30°C) għal perjodu wieħed ta' massimu ta' 72 siegħa.
English: In clinical trials, Neulasta has been safely administered 14 days before chemotherapy.
Maltese: Fi-provi kliniċi, Neulasta ingħata b'mod sikur 14-il jum qabel il-kimoterapija.
English: • You should see a black line next to the 0% (empty) indicator to confirm you have received a full dose.
Maltese: • Għandek tara linja sewda ħdejn l-indikatur li juri 0% (vojt) biex tikkonferma li rċevejt doża sħiħa.
English: Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Maltese: Intwera li pegfilgrastim u filgrastim għandhom modi ta' azzjoni identiċi, u jikkawżaw żieda sinifikanti fl-għadd ta' newtrofili fid-demm periferali fi żmien 24 siegħa, b'żidiet minuri fil-monoċiti u/jew fillimfoċiti.
English: • cutaneous vasculitis (inflammation of the blood vessels in the skin).
Maltese: • vaskulite fil-ġilda (infjammazzjoni fil-vini/arterji taħt il-ġilda).
English: • Do not expose the on-body injector to the following because the on-body injector may be damaged and you could be injured: - Diagnostic imaging (e.g. CT scan, MRI, ultrasound, x-ray).
Maltese: - Imaġini dijanjostiċi (eż. CT scan, MRI, ultrasound, x-ray).
English: In a phase I (n = 253) randomised, single dose, parallel-group study conducted in healthy subjects the exposure (mean serum concentration-time profiles) of pegfilgrastim delivered by manual injection and by the on-body injector were comparable.
Maltese: Fi studju ta' fażi I (n = 253) randomised, b'doża waħda, bi grupp parallel imwettaq f'individwi f'saħħithom, l-esponiment (il-profili medji tal-konċentrazzjoni mal-ħin fis-serum) ta' pegfilgrastim mogħti permezz ta' injezzjoni manwali u permezz ta' injettatur li jeħel mal-ġisem kienu komparabbli.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jista' jaffetwa sa pazjent wieħed minn kull 100 persuna):
English: Capillary leak syndrome
Maltese: Sindrome ta' tnixxija talkapillari
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: 1 See section “Description of selected adverse reactions” below.
Maltese: 1 Ara sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” hawn taħt.
English: Neulasta 6 mg solution for injection
Maltese: Neulasta 6 mg soluzzjoni għall-injezzjoni
English: Do not administer pegfilgrastim to patients with a history of hypersensitivity to pegfilgrastim or filgrastim.
Maltese: Tagħtix pegfilgrastim lil pazjienti bi storja ta' sensittività eċċessiva għal pegfilgrastim jew filgastrim.
English: If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Maltese: Jekk ikollok telf ta' rispons jew falliment li jinżamm rispons bi trattament ta' pegfilgrastim, it-tabib tiegħek se jinvestiga r-raġunijiet għaliex, inkluż jekk żviluppajtx antikorpi li jinnewtralizzaw l-attività ta' pegfilgrastim.
English: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Maltese: Mhux rakkomandata bidla fid-doża f'pazjenti b'indeboliment tal-kliewi, inkluż dawk b'mard talkliewi fl-aħħar stadju.
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Maltese: IMBOTTA l-planġer bill-mod u b' pressjoni konstanti sakemm tħoss u tisma “tfaqqiħa”.
English: Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Maltese: Dożi singoli ta' 300 mcg/kg ġew mogħtija taħt il-ġilda lil numru limitat ta' voluntiera f'saħħithom u pazjenti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun mingħajr reazzjonijiet avversi serji.
English: STOP
Maltese: Tqala
English: • If medicine has leaked or the adhesive is noticeably wet (saturated), contact your healthcare provider immediately as you may not have received your full dose and you may need a replacement dose.
Maltese: • Jekk id-dawl li juri x'qed jiġri jteptep aħmar, jista' jkun li ma rċevejtx id-doża sħiħa tiegħek u jista' jkollok bżonn doża ta' sostituzzjoni.
English: Median Serum Pegfilgrastim Conc.
Maltese: Konċ. Medjana ta' Pegfilgrastim fis-Serum (ng/ml)
English: How to store Neulasta
Maltese: Jekk tinsa tinjetta Neulasta
English: • Even with a leak, the status light may remain green and the fill indicator may be at 0% (empty).
Maltese: • Anke jekk ikun hemm tnixxija, id-dawl li juri x'qed jiġri jista' jibqa' aħdar u l-indikatur li juri kemm hu mimli jista' jkun fuq 0% (vojt).
English: • if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine.
Maltese: • jekk inti allerġiku għal pegfilgrastim, filgrastim, jew għal xi sustanza oħra ta' din il-mediċina.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Maltese: Dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħrajn, partikolarment ma' soluzzjonijiet ta' sodium chloride.
English: Finger grips
Maltese: Labra użata
English: * Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Maltese: *Magħmul f'ċelluli ta' Escherichia coli permezz ta' teknoloġija tat-tfassil tad-DNA segwita minn konjugazzjoni ma' polyethylene glycol (PEG). **Il-konċentrazzjoni hija ta' 20 mg/mL jekk jiġi inkluż il-porzjoni PEG.
English: The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Maltese: L-eliminazzjoni ta' pegfilgrastim mhux lineari mad-doża; u t-tneħħija mis-serum ta' pegfilgrastim tonqos hekk kif tiżdied id-doża.
English: Transient elevations in LFTs for ALT or AST
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: Remember
Maltese: INDIVIDWALI
English: Belly
Maltese: UŻU
English: Amgen Biotechnologia Sp. z o.o.
Maltese: Aħsel idejk sew bis-sappun u l-ilma.
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq l-immaniġġar tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Maltese: Għall-injezzjoni aktar komda, ħalli is-siringa mimlija għal-lest toqgħod għal 30 minuta sabiex tilħaq temperatura ambjentali, jew żomm is-siringa mimlija għal-lest delikatament f'idejk għal ftit minuti.
English: Common cases of thrombocytopenia have been reported.
Maltese: Prodott mediċinali li jingħata bir-riċetta tat-tabib.
English: • Upper part of your thigh.
Maltese: • Il-parti ta fuq tal-koxxa.
English: After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Elderly
Maltese: Pożoloġija
English: • serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
Maltese: • reazzjonijiet allerġiċi serji, inkluż anafilassi (debbulizza, pressjoni titbaxxa, tbatija biex tieħu n nifs, nefħa fil-wiċċ).
English: Pack size of one.
Maltese: Pakkett ta' waħda.
English: • the top of your thighs; and
Maltese: • taħseb li inti tqila; jew
English: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Maltese: Wara doża waħda ta' pegfilgrastim taħt il-ġilda, l-ogħla konċentrazzjoni fis-serum ta' pegfilgrastim tintlaħaq minn 16 sa 120 siegħa wara d-dożaġġ u l-konċentrazzjonijiet fis-serum ta' pegfilgrastim jinżammu tul il-perjodu ta' newtropenija wara kimoterapija majelosoppressiva.
English: 9/L after the expected nadir, this medicine should be discontinued immediately.
Maltese: 9/L, din il-mediċina għandha titwaqqaf minnufih.
English: BLISTER PACK FOR SYRINGE WITH AUTOMATIC NEEDLE GUARD
Maltese: PAKKETT TAL-FOLJA GĦAL SIRINGA BI PROTEZZJONI AWTOMATIKA TAL-LABRA
English: Consistent with a self-regulating clearance mechanism, the serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see figure 1).
Maltese: Konsistenti ma' mekkaniżmu ta' tneħħija li jirregola lilu nnifsu, il-konċentrazzjoni fis-serum ta' pegfilgrastim tonqos b'ħeffa kbira malli jibdew jirpiljaw in-newtrofili (ara figura 1).
English: Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Reporting of suspected adverse reactions
Maltese: Ir-rappurtar ta' reazzjonijiet avversi suspettati
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 l-effikaċja tal-għoti ta' pegfilgrastim ma' ċitoġenetiċi t(15;17) f'pazjenti taħt il-55 sena li reġgħet qabdithom AML mill-ġdid, għadhom ma ġewx determinati s'issa.
English: • redness at the site of injection.
Maltese: • uġigħ fil-post tal-injezzjoni.
English: In animal models concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Maltese: Fi studji fuq lannimali, l-għoti ta' Neulasta flimkien ma' 5-fluorouracil (5-FU) jew anti-metaboliti oħra intwera li jżid il-majelosoppressjoni.
English: Step 3: Inject A Hold the pinch.
Maltese: Pass 2: Kun Lesta A Aħsel idejk sew.
English: For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting.
Maltese: Għal injezzjoni aktar komda, ħalli is-siringa mimlija għal-lest fit-temperatura tal-kamra għal madwar 30 minuta qabel tinjeta.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' pegfilgrastim* f'0.6 mL ta' soluzzjoni għall-injezzjoni.
English: Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Maltese: Trattament b'pegfilgrastim waħdu ma jeskludix tromboċitopenija u anemija minħabba li tinżamm iddoża sħiħa ta' kimoterapija majelosoppressiva fl-iskeda preskritta.
English: Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Maltese: Bħal fil-każ ta' filgrastim, in-newtrofili li jiġu magħmula b'rispons għal pegfilgrastim juru funzjonijiet normali jew miżjuda kif intwera minn testijiet dwar il-funzjoni kimotattika u fagoċitika.
English: • Tell your healthcare provider if you have an allergy to latex.
Maltese: • Għid lill-fornitur tal-kura tas-saħħa tiegħek jekk għandek allerġija għall-latex.
English: • Dose delivery will start and take about 45 minutes to complete.
Maltese: • L-għoti tad-doża jibda u jieħu madwar 45 minuta biex jitkompla.
English: You can use:
Maltese: Tista' Tuża:
English: • if you have sickle cell anaemia.
Maltese: • jekk inti għandek anemija taċ-ċellula sickle.
English: Ref. EMEA/505188/2009 EMEA/H/C/1069
Maltese: EMEA/702718/2009 EMEA/H/C/1069
English: London, 20 August 2009 Doc.
Maltese: Londra, 20 ta' Awwissu 2009 Dok. ta' ref.
English: What is Bosatria?
Maltese: X'inhu Bosatria?
English: It contains the active substance mepolizumab.
Maltese: Fih is-sustanza attiva mepolizumab.
English: The active substance in Bosatria, mepolizumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Bosatria, mepolizumab, hija anitkorp monoklonali.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Bosatria is available here.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Bosatria huwa disponibbli hawnhekk.
English: Mepolizumab has been designed to attach to a chemical messenger called interleukin 5 (IL-5), which is involved in the growth of eosinophils.
Maltese: Mepolizumab ġie mfassal sabiex jeħel ma' messaġġier kimiku imsejjaħ interleukin 5 (IL-5), li huwa involut fit-tkabbir tal-esinofili.
English: In one main study involving 85 adults with hypereosinophilic syndrome, Bosatria was compared with placebo (a dummy treatment).
Maltese: Fi studju prinċipali wieħed li nvolva 85 adult b'sindromu iperesinofiliku, Bosatria tqabbel ma' plaċebo (trattament finta).
English: Bosatria was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 July 2004 for the treatment of hypereosinophilic syndrome.
Maltese: Bosatria ġie denominat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fid-29 ta' Lulju 2004 għall-kura tas-sindromu iperesonifiliku.
English: Bosatria was expected to be used to treat adults with hypereosinophilic syndrome.
Maltese: Bosatria kien mistenni li jintuża għat-trattament ta' adulti b'sindromu iperesinofiliku.
English: What was Bosatria expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Bosatria?
English: On 28 July 2009, Glaxo Group Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Bosatria, for the treatment of adults with hypereosinophilic syndrome to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
Maltese: Fit-28 ta' Lulju 2009, Glaxo Group Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni għallawtorizzazzjoni għat-tqegħid fis-suq għal Bosatria, għall-kura ta' adulti b'sindromu iperesinofiliku għat-tnaqqis jew l-eliminazzjoni tal-ħtieġa għal terapija b'kortikosterojde u għat-tnaqqis tal-għadd ta' esinofili fid-demm.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Bosatria could not have been approved for the treatment of adults with hypereosinophilic syndrome who lack the FIP1L1-PDGRF fusion gene, to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fiżżmien tal-irtirar, is-CHMP wera xi tħassib u kien tal-opinjoni provviżorja li Bosatria ma setax jiġi approvat għall-kura ta' adulti b'sindromu iperesinofiliku li għandhom il-ġene ta' fużjoni FIP1L1PDGRF nieqes, biex inaqqas jew jelimina l-ħtieġa għal pazjenti li jiġu kkurati b'kortikosterojdi u biex inaqqas l-għadd ta' esinofili.
English: By attaching to IL-5, mepolizumab was expected to reduce the accumulation of eosinophils in the blood, thereby relieving the symptoms of patients with hypereosinophilic syndrome.
Maltese: Billi jeħel ma' IL-5, mepolizumab huwa mistenni li jnaqqas l-akkumulazzjoni ta' esinofili fid-demm, b'hekk itaffi s-sintomi ta' pazjenti bis-sindromu iperesinofiliku.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li ġie mfassal sabiex jagħraf u jeħel ma' struttura speċifika (imsejħa antiġen) li tinsab fil-ġisem.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Bosatria did not outweigh its risks in the treatment of adults with hypereosinophilic syndrome who lack the FIP1L1-PDGRF fusion gene, to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
Maltese: Is-CHMP kien tal-opinjoni li l-istudju ewlieni ma pprovdiex biżżejjed evidenza biex juri li Bosatria kien effikaċi fit-tnaqqis tal-ħtieġa għal trattament b'kortikosterojdi.
English: Bosatria was expected to be used in patients who lack a gene called the ‘FIP1L1-PDGRF fusion gene' to reduce or eliminate the need for the patients to be treated with corticosteroids (steroids used to treat the disease) and to reduce the level of eosinophils in the blood.
Maltese: Bosatria kien mistenni li jintuża f'pazjenti li għandhom nieqes ġene msejjaħ ‘il-ġene tal-fużjoni FIP1L1-PDGRF' biex inaqqas jew jelimina l-ħtieġa għall-pazjenti milli jiġu kkurati b'kortikosterojdi (sterojdi użati fil-kura tal-marda) u biex inaqqas il-livell ta' esinofili fid-demm.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Fuq ilbażi tar-reviżjoni tad-dokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-jum 120, li mbagħad tintbagħat lill-kumpanija.
English: Bosatria is a powder that is made up into a solution for infusion (drip into a vein).
Maltese: Bosatria huwa trab li jkun magħmul f'soluzzjoni għal infużjoni (dripp fil-vina).
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Wara li s-CHMP evalwa t-tweġibiet millkumpanija għal lista ta' mistoqsijiet, kien għad fadal xi kwistjonijiet pendenti li kienu għadhom ma ġewx solvuti.
English: All patients lacked the FIP1L1-PDGRF fusion gene and were receiving treatment with prednisone (a corticosteroid) that was helping to stabilise their symptoms.
Maltese: Il-pazjenti kollha kellhom nieqes il-ġene ta' fużjoni FIP1L1-PDGRF u kienu qegħdin jirċievu kura bi prednisone (kortikosterojde) li kien qed jgħinhom jistabbilizzaw issintomi tagħhom.
English: It may harm them,
Maltese: Generu Sesswali
English: Teva Ελλάς Α.Ε.
Maltese: Ελλάς Α.Ε.
English: Urinary CTx **
Maltese: CTx urinarju **
English: (see sections 5.1 and 5.2).
Maltese: (ara sezzjoni 5.2).
English: Date of latest renewal: 25 June 2015
Maltese: Data tal-aħħar tiġdid: 25 ta' Ġunju 2015
English: Acetylsalicylic acid and NSAIDs
Maltese: Acetylsalicylic acid u NSAIDs
English: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem The Netherlands
Maltese: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem L-Olanda
English: Teva Italia S.r.l.
Maltese: Italia S.r.l.
English: UAB "Sicor Biotech" filiāle Latvijā
Maltese: UAB "Sicor Biotech"
English: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG, Belgique/Belgien
Maltese: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.
English: Teva Czech Industries s.r.o Ostravska 29/305, 747 70 Opava-Komarov Czech Republic
Maltese: Teva Czech Industries s.r.o Ostravska 29/305, 747 70
English: Lumbar spine L2-L4
Maltese: BMD L2-L4
English: 2031 GA Haarlem The Netherlands
Maltese: 2031 GA Haarlem L-Olanda
English: Placebo n=277
Maltese: Plaċebo n=277
English: System Organ Class
Maltese: Sistema talKlassifika tal-Organi
English: Manufacturer:
Maltese: Manifattur:
English: Placebo (N=587)
Maltese: Plaċebo (N=587)
English: Placebo (N=974)
Maltese: Plaċebo (n=974)
English: Month 2 __/__/__
Maltese: Xahar 2 __/__/__
English: Mutagenicity/Carcinogenicity:
Maltese: Mutaġeniċità/Karċinoġeniċit:
English: • tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid;
Maltese: • il-qalba tal-pillola: cellulose microcrystalline, povidone K-30, crospovidone (tip A), silica colloidal anhydrous, stearic acid;
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 ta' Settembru 2010
English: Month 1 __/__/__
Maltese: Xahar 1 __/__/__
English: Month 3 __/__/__
Maltese: Xahar 3 __/__/__
English: p-value
Maltese: Valur p
English: Common Uncommon Rare
Maltese: Mhux komuni Rari
English: Clinically meaningful reductions in serum CTX levels were observed at all time points measured, i.e. months 3, 6, 12 and 24.
Maltese: Tnaqqis kliniku notevoli fil-livelli ta' CTX fis-serum kienu osservati fil-punti kollha tal-ħin imkejla, i.e. fix-xhur 3, 6, 12 u 24.
English: Gastrointestinal disorders*
Maltese: Disturbi gastrointestinali*
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
English: • tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80.
Maltese: • il-kisi tal-pillola: titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80.
English: This reduction in urinary CTx levels was significantly correlated with the primary efficacy endpoint SMPR (Kendall-tau-b (p<0.001)).
Maltese: Dan it-tnaqqis fil-livelli urinarji ta' CTx kien korrelat b'mod sinifikattiv mal-mira primarja tal-effikaċja ta' SMPR (Kendall-tau-b (p<0.001)).
English: All patients received 500 mg calcium and 400 IU vitamin D daily.
Maltese: Il-pazjenti kollha ħadu 500 mg ta' kalċju u 400 IU vitamina D kuljum.
English: Mean relative changes from baseline % [95 % CI]
Maltese: Bidliet relattivi fil-medja mill-punt ta' riferiment % [95% CI]
English: - a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Maltese: - tirċievi tip ta' injezzjoni ta' antibijotiku msejjaħ “aminoglycoside” bħal gentamicin.
English: BMD
Maltese: BMD Troxanter
English: The incidence of clinical vertebral fractures was also significantly reduced by 49 % (p=0.011).
Maltese: L-inċidenza ta' ksur vertebrali kliniku naqas b'mod sinifikanti wkoll b'49 % (p=0.011).
English: Total hip BMD
Maltese: BMD Ġenbejn totali
English: EU/1/10/642/002 84 film-coated tablets
Maltese: EU/1/10/642/002 84 pillola miksija b'rita
English: Gastrointestinal irritation
Maltese: Irritazzjoni gastrointestinali
English: Opadry white YS-1-7003: Titanium dioxide (E 171) Hypromellose Macrogol 400
Maltese: Titanium dioxide (E171) Hypromellose Macrogol 400
English: StevensJohnson syndrome†, erythema multiforme†, dermatitis bullous†
Maltese: Sindrome ta' StevensJohnson†, Eritema Multiforme†, Dermatite blInfafet†
English: WHO performance score *
Maltese: Punteġġ ta' prestazzjoni ta' WHO *
English: Attention should also be paid to the possible existence of simultaneous hypomagnesaemia.
Maltese: Għandha tingħata attenzjoni wkoll għal possibilità ta' esistenza ta' ipomanjesimja simultanja.
English: Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI)
Maltese: Tabella 3: Riżultati mill-istudju mf 4411 dwar ksur mifrux fuq 3 snin (%, 95% CI)