FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Maltese: Informazzjoni li mhix klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq ilġeni, riskju ta' kanċer, ma' turi l-ebda periklu speċjali għall-bnedmin.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C when reconstitution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, iż-żmien tal-ħażna waqt l-użu u l-kundizzjonijiet ta' qabel l-użu huma rresponsabbiltà ta' min qed jużah, u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2 sa 8°C, meta r-rikostituzzjoni tkun saret f'kundizzjonijiet asettiċi kkontrollati u vverifikati.
English: Increase in serum transaminases
Maltese: Adulti u pazjenti anzjani
English: Powder and solvent for solution for injection 15mg of powder in a vial and 0.5ml of solvent in an ampoule
Maltese: 15 mg ta' trab ġo kunjett u 0.5 ml ta' solvent f'ampulla
English: The disappearance of desirudin from plasma is rapid in the first phase with approximately 90% of an intravenous (IV) bolus dose disappearing from the circulation within 2 hours of the injection.
Maltese: It-tneħħija mill-plażma ta' desirudin huwa mgħaġġel fl-ewwel fażi, b'madwar 90% ta' doża bolus ġolvina (IV) tisparixxi miċ-ċirkolazzjoni, fi żmien sagħtejn ta' l-injezzjoni.
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jiżgura li s-sistema ta' farmakoviġilanza, inkluża f' Modulu 1.8.1 tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott ikun fuq is-suq.
English: That activity should be taken into account in the evaluation of the overall coagulation status of the patient during the switch (see section 4.2).
Maltese: Dik l-attività trid titqies meta ssir l-evalwazzjoni ta' l-istatus sħiħ tal-koagulazzjoni fil-pazjent waqt il-bidla (ara sezzjoni 4.2).
English: After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges.
Maltese: Revasc 15 mg / 0.5 ml trab u solvent għas-soluzzjoni għall-injezzjoni Desirudin
English: Metabolites lacking one or two C-terminal amino acids constitute a minor proportion of the material recovered from urine (<7%).
Maltese: Ilmetaboliti, li għandhom wieħed jew żewġ amminoaċidi neqsin mis-C-terminal, jagħmlu proporzjon żgħir tal-materjal irkuprat mill-awrina (< 7%).
English: In post-marketing surveillance, rare reports of major haemorrhages, some of which were fatal; and rare reports of non-fatal anaphylactic or anaphylactoid reactions leading to shock have been received.
Maltese: emorraġiji serji, li xi ftit minnhom kienu fatali, u waslu rapporti rari ta' reazzjonijiet anafilattiċi jew anafilattojdi mhux fatali li wasslu għal xokk.
English: 4.2 Posology and method of administration Treatment with Revasc should be initiated under the guidance of a physician with experience in coagulation disorders.
Maltese: 4.2 Posoloġija u metodu ta' kif għandu jingħata Il-kura b'Revasc trid tinbeda taħt is-sorveljanza ta' tabib li għandu esperjenza fid-disturbi tal koagulazzjoni.
English: Increase in liver enzymes, dizziness, sleeplessness, confusion, feeling breathless, vomiting (with or without blood), constipation, blood in your urine, difficulty in urinating, rash, itching (urticaria), low levels of potassium in the blood, burning feeling when passing urine with also an increased frequency of urination, slow healing of wounds, nose bleeds, high blood pressure, pain (including pain in legs,
Maltese: Żieda fl-enzimi tal-fwied, sturdament, ma tkunx tista' torqod, konfużjoni, tħossok bla nifs, rimettar (bi jew mingħajr demm), stitikezza, demm fl-awrina tiegħek, diffikultà biex tagħmel l-awrina, raxx, ħakk
English: You will be given Revasc as an injection under the skin.
Maltese: M'għandekx tingħata Revasc jekk inti tqila.
English: In vitro and in vivo animal data indicate that desirudin is for the most part eliminated and metabolised by the kidney.
Maltese: Tagħrif in vitro u in vivo fl-annimali jindikaw li desirudin huwa fil-parti l-kbira eliminat u metabolizzat mill-kliewi.
English: - with severe uncontrolled hypertension and subacute bacterial endocarditis.
Maltese: - bi pressjoni għolja ħafna u mhux ikkontrollata, u b'endokardite batterjali subakuta. 4.4
English: A mean peak aPTT prolongation of around 1.4 times baseline value is observed following a subcutaneous (SC) b.i.d.
Maltese: madwar 1.4 drabi tal-valur fil-bidu, wara injezzjoni subkutanja (SC) b.i.d. ta' 15 mg desirudin.
English: When desirudin is administered in patients with increased risk of bleeding complications, mild to moderate hepatic dysfunction and/or mild to moderate renal impairment, aPTT should be monitored and peak aPTT should not exceed twice the control value.
Maltese: Peress li dawn ir-reazzjonijiet huma ikkaġunati minn mekkaniżmi immunoloġiċi, pazjenti li diġà ħadu hirudin, jew analogu tiegħu, għandhom riskju miżjud.
English: Patients with renal impairment
Maltese: Disturbi fis-sistema immuni
English: Desirudin is distributed in the extracellular space with a distribution volume at steady state of 0.251/kg independently of the dose.
Maltese: Desirudin huwa distribwit fl-ispazju ta' barra ċ-ċelluli, b'volum ta' distribuzzjoni fiss ta' 0.25 l/kg,
English: EU/1/19/1382/001 Azacitidine Celgene 25 mg/ml
Maltese: EU/1/19/1382/001 Azacitidine Celgene
English: Subcutaneous use vial (glass) 100 mg
Maltese: Kunjett (ħġieġ) 100 mg
English: (Invented) name Strength Pharmaceutical form
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Powder for suspension for injection
Maltese: 25 mg/ml Trab għal suspensjoni għall-injezzjoni
English: 24 July 2013
Maltese: 24 ta' Lulju 2013
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
Maltese: Implimentazzjoni tal-ftehim mill-Istati Membri (preżentazzjoni tal-varjazzjoni mid-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq):
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Maltese: Trażmissjoni lill-Awtoritajiet Nazzjonali Kompetenti tad-traduzzjonijiet tal-Annessi għallFtehim:
English: 01 October 2013
Maltese: 01 ta' Ottubru 2013
English: Annex IV
Maltese: Anness IV Skeda għall-implimentazzjoni tal-ftehim
English: EMA/CHMP/842278/2011 Rev. 1 EMEA/H/A-29/1294
Maltese: EMA/CHMP/842278/2011 Rev.
English: The company wanted the authorisation to be recognised in Belgium, Bulgaria, Cyprus, Czech, Denmark, Estonia, Greece, France, Hungary, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Slovakia and the United Kingdom (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tiġi rikonoxxuta fil-Belġju, fil-Bulgarija, f'Ċipru, fir-Repubblika Ċeka, fidDanimarka, fl-Estonja, fil-Greċja, fi Franza, fl-Ungerija, fl-Irlanda, fl-Islanda, fil-Litwanja, filLussemburgu, fil-Latvja, f'Malta, fil-Pajjiżi l-Baxxi, fin-Norveġja, fil-Polonja, fir-Rumanija, fis-Slovenja, fis-Slovakkja u fir-Renju Unit (l-‘Istati Membri kkonċernati').
English: What is Priligy?
Maltese: X'inhu Priligy?
English: Priligy is a medicine used to treat premature ejaculation in men aged 18 to 64 years old.
Maltese: Priligy huwa mediċina użata fil-kura ta' eġakulazzjoni prematura fl-irġiel minn 18 sa 64 sena.
English: Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets) EMA/59013/2012
Maltese: Mistoqsijiet u tweġibiet dwar Priligy (dapoxetine, pilloli ta' 30 mg u 60 mg) EMA/106778/2012
English: The active substance, dapoxetine, is a selective serotonin re-uptake inhibitor (SSRI) and it works by preventing the neurotransmitter 5-hydroxytryptamine (also called serotonin) from being taken back up into nerve cells in the brain and spinal cord, thereby increasing the amount of serotonin between nerve cells.
Maltese: Is-sustanza attiva, dapoxetine, hija inibitur selettiv ta' ġbir mill-ġdid ta' serotonin (SSRI) u taħdem billi twaqqaf in-newrotrasmettitur 5-hydroxytryptamine (magħruf ukoll bħala serotonin) milli jerġa' jittieħed lura għaċ-ċelloli tan-nervituri fil-moħħ u fl-ispina dorsali, u b'hekk iżżid l-ammont ta' serotonin bejn iċ-ċelloli tan-nervituri.
English: Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets)
Maltese: Mistoqsijiet u tweġibiet dwar Priligy (dapoxetine, pilloli ta' 30 mg u 60 mg)
English: Why was Priligy reviewed?
Maltese: Għalxiex ġie rivedut Priligy?
English: The CHMP also concluded that the potential increased risk for syncope has been proven to be manageable.
Maltese: Is-CHMP ikkonkluda wkoll li ż-żieda potenzjali fir-riskju ta' sinkope ġiet ippruvata li tista' tiġi mmaniġġjata.
English: The company that markets Priligy in Sweden, Janssen-Cilag AB, submitted an application to market Priligy (30 mg and 60 mg tablets) through the mutual recognition procedure based on the initial authorisation granted by Sweden on 6 February 2009.
Maltese: Il-kumpanija li tqiegħed lil Priligy fis-suq fl-Isvezja, Janssen-Cilag AB, issottomettiet applikazzjoni biex tqiegħed lil Priligy (pilloli ta' 30 mg u ta' 60 mg) fis-suq permezz tal-proċedura ta' rikonoxximent reċiproku bbażata fuq l-awtorizzazzjoni inizjali mogħtija mill-Isvezja fis-6 ta' Frar 2009.
English: The grounds for the referral were concerns over the benefit-risk balance of the 60 mg tablet by some Member States, who considered its additional benefit compared with the 30 mg tablet to be too modest when weighed against the increased risk of severe cases of syncope (fainting) seen in studies with the medicine.
Maltese: Ir-raġunijiet għar-riferiment kienu tħassib minn xi Stati Membri dwar il-bilanċ tal-benefiċċju-riskju talpillola ta' 60 mg, li kkunsidraw li l-benefiċċju addizzjonali tagħha meta mqabbla mal-pillola ta' 30 mg kien modest wisq meta mqabbel maż-żieda fir-riskju ta' każijiet severi ta' sinkope (ħass ħażin) li dehru fl-istudji bil-mediċina.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Priligy tablets.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-pilloli Priligy.
English: Patients should not start treatment with 60 mg tablets, and may only be switched to 60 mg if they have not responded sufficiently to the 30 mg tablets and have not experienced moderate or severe adverse reactions or symptoms suggestive of syncope.
Maltese: Pazjenti ma għandhomx jibdew kura bil-pilloli ta' 60 mg, u jistgħu jinqelbu biss għal 60 mg jekk ma jkunux irrispondew biżżejjed għall-pilloli ta' 30 mg u ma jkunux esperjenzaw reazzjonijiet avversi moderati jew severi jew sintomi li jissuġġerixxu sinkope.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Priligy 60 mg outweigh its risks, and that therefore the marketing authorisation for Priligy (30 mg and 60 mg) should be granted in all concerned Member States.
Maltese: Abbażi tal-evalwazzjoni tad-dejta attwalment disponibbli u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP ikkonkluda li l-benefiċċji ta' Priligy 60 mg jegħlbu r-riskji tiegħu, u li għalhekk lawtorizzazzjoni għat-tqegħid fis-suq għal Priligy (30 mg u 60 mg) għandha tingħata fl-Istati Membri kkonċernati kollha.
English: Other information about Puregon:
Maltese: Informazzjoni oħra dwar Puregon:
English: Puregon contains the active substance follitropin beta.
Maltese: Puregon fih is-sustanza attiva follitropin beta.
English: The marketing authorisation was renewed on 3 May 2001 and on 3 May 2006.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-3 ta' Mejju 2001 u fit-3 ta' Mejju 2006.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREGON EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) PUREGON Sommarju tal-EPAR għall-pubbliku
English: The marketing authorisation holder is N.V. Organon.
Maltese: Id-detentur tal-awtorizzazzjoni huwa N.V.
English: The active substance in Puregon, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH).
Maltese: Is-sustanza attiva f'Puregon, follitropina beta, hija kopja tal-ormon naturali li jistimula l-follikulu li jistimula l-ormoni (FSH).
English: The follitropin beta in Puregon is produced by a method known as ‘recombinant DNA technology'.
Maltese: Il-follitropina beta f'Puregon huwa magħmul permezz ta' metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti':
English: In 4 % of the women treated with Puregon in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain, and diarrhoea) have been reported.
Maltese: F'4 % tan-nisa ttrattati b'Puregon fi studji kliniċi, ġew irrappurtati sinjali u sintomi relatati mas-sindromu minn iperstimulazzjoni tal-ovarji (eż. tħossok ma tiflaħx, żieda fil-piż u dijarrea).
English: Puregon must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus.
Maltese: Puregon ma għandux jintuża f'pazjenti b'tumuri fl-ovarji, fis-sider, filġuf, fit-testikoli, fil-glandola pitwitarja jew fl-ipotalama.
English: Why has Puregon been approved?
Maltese: Għaliex ġie approvat Puregon?
English: • women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation).
Maltese: • nisa li huma anovulatorji (ma jipproduċux ovuli) u ma jirrispondux għat-trattament ta' klomifen ċitrat (mediċina oħra li tistimula l-ovulazzjoni);
English: What is Puregon?
Maltese: X'inhu Puregon?
English: Puregon's use in women undergoing fertility treatment has been studied in 981 patients.
Maltese: L-użu ta' Puregon fin-nisa li jgħaddu minn trattament ta' fertilità ġie studjat f'981 pazjent.
English: Treatment with Puregon should be carried out by a doctor who has experience in the treatment of fertility problems.
Maltese: It-trattament b'Puregon għandu jsir minn tabib li għandu esperjenza fit-trattament ta' problemi ta' fertilità.
English: Puregon was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
Maltese: Puregon ġie studjat f'172 mara anavolutorja, bil-kejl ta' kemm ċikli ta' trattament kienu meħtieġa għal dawn in-nisa sabiex jovulaw.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Puregon's benefits are greater than its risks in the female for the treatment of infertility, and in the male for deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Puregon huma akbar mir-riskji tiegħu f'nisa għat-trattament tal-infertilità, u li fl-irġiel għal defiċjenza ta' spermatoġeneżi minħabba ipogonadiżmu ipogonadotrofiku.
English: In the body, FSH regulates the reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
Maltese: L-FSH jirregola l-funzjoni riproduttiva fil-ġisem: fin-nisa, jistimula lproduzzjoni tal-ovuli u fl-irġiel jistimula l-produzzjoni tal-isperma mit-testikoli.
English: Puregon can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Maltese: Puregon jista' jintuża wkoll sabiex jistimula l-produzzjoni tal-isperma fl-irġiel li għandhom lipogonadiżmu ipogonadotrofiku (marda rari ta' defiċjenza ormonali).
English: For a full list of all side effects reported with Puregon, see the Package Leaflet.
Maltese: Għal lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Puregon, ara l-Fuljett ta' Tagħrif.
English: Puregon was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.
Maltese: Puregon kien effettiv bħala FSH urinarja bħal trattament ta' fertilità fil-produzzjoni ta' ovoluzzjoni u fil-produzzjoni tal-isperma.
English: Previously, the FSH used as a medicine was extracted from urine.
Maltese: Preċedentement, lFSH użat bħala mediċina kien estratt mill-urina.
English: How has Puregon been studied?
Maltese: Kif ġie studjat Puregon?
English: In all of the studies, Puregon was compared to the natural FSH hormone that was extracted from urine.
Maltese: Fl-istudji kollha, Puregon ġie mqabbel mal-ormon natural FSH li kien estratt mill-urina.
English: Puregon is a powder and solvent to be made up into a solution for injection.
Maltese: Puregon jikkonsisti minn trab u solvent li jitħalltu biex tinħoloq soluzzjoni għal injezzjoni.
English: Puregon is used to treat infertility in women in the following situations:
Maltese: Puregon huwa użat għat-trattament tal-infertilità ta' nisa fis-sitwazzjonijiet li ġejjin:
English: What is the risk associated with Puregon?
Maltese: X'inhu r-riskju assoċjat ma' Puregon?
English: It is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Maltese: Huwa jsir permezz ta' ċellola li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi l-FSH uman.
English: The dose and frequency of administration of Puregon depend on its use (see above) and the patient's response to treatment.
Maltese: Id-doża u l-frekwenza ta' amministrazzjoni ta' Puregon jiddependu fuq l-użu tiegħu (ara hawn fuq) u r-rispons tal-pazjent għat-trattament.
English: Puregon is administered to stimulate the ovaries to produce more than one egg at a time
Maltese: Puregon jingħata sabiex jistimula l-ovarji sabiex jipproduċu aktar minn bajda waħda f'ħin wieħed.
English: In men, Puregon was studied to see its effect on sperm production in 49 patients.
Maltese: Fl-irġiel, Puregon ġie studjat sabiex jiġi ċċekkjat l-effett fuq il-produzzjoni tal-isperma f'49 pazjent.
English: Oral use blister (OPA/aluminium/PVC/ aluminium)
Maltese: Pillola miksija b'rita Użu orali folja (OPA/aluminju/PVC/aluminju)
English: Cats and dogs
Maltese: Perjodu ta' Tiżmim
English: It may harm them,
Maltese: (tromboċitopenija) wara li jitwaqqaf Nplate;
English: One Amgen Center Drive Thousand Oaks, CA 91320 USA
Maltese: One Amgen Center Drive Thousand Oaks, CA 91320 L-Istati Uniti tal-Amerika
English: • anaemia.
Maltese: • anemija.
English: Perform step 3a before step 3b.
Maltese: Wettaq pass 3a qabel pass 3b.
English: MedDRA system organ class
Maltese: Klassi tas-Sistemi u tal-organi MedDRA
English: • palpitations.
Maltese: • palpitazzjonijiet.
English: 9/L in the absence of rescue medication) was 93.8% (n = 61) and was similar across age groups.
Maltese: 9/L fin-nuqqas ta' medikazzjoni ta' salvataġġ) kien ta' 93.8% (n = 61) u kien simili matul il-gruppi ta' età.
English: 4 vials.
Maltese: 4 kunjetti.
English: Progression of existing Myelodysplastic Syndromes (MDS)
Maltese: Progressjoni ta' Sindromi Mijelodisplastiċi (MDS - Myelodysplastic Syndromes) eżistenti
English: 4 alcohol swabs.
Maltese: 4 imsielaħ tal-alkoħol.
English: • indigestion (dyspepsia);
Maltese: • indigestjoni (dispepsja);
English: 9/L during weeks 18 through 25 of treatment.
Maltese: 9/L matul ġimgħat 18 sa 25 tattrattament.
English: Possible side effects in adults with ITP
Maltese: Effetti sekondarji possibbli f'adulti b'ITP
English: In Study S6 (340), intensive romiplostim concentrations were available from 4 subjects (2 at 7 mcg/kg and 2 at 9 mcg/kg).
Maltese: Fl-Istudju S6 (340), konċentrazzjonijiet intensivi ta' romiplostim kienu disponibbli minn 4 individwu (2 ta' 7 mcg/kg u 2 ta' 9 mcg/kg).
English: Gastroenteritis Pharyngitis*** Conjunctivitis*** Ear infection*** Sinusitis***
Maltese: Gastroenterite Farinġite*** Konġuntivite*** Infezzjoni filwidnejn*** Sinużite***
English: 1 sterile 1 mL Luer lock syringe.
Maltese: Siringa sterili ta' 1 mL b'Luer lock.
English: The incidence of thrombotic/thromboembolic events observed in clinical trials was 6.0% with romiplostim and 3.6% with placebo.
Maltese: L-inċidenza ta' avvenimenti trombotiċi/tromboemboliċi osservata fi provi kliniċi kienet ta' 6.0% b'romiplostim u ta' 3.6% bil-plaċebo.
English: Date of first authorisation: 4 February 2009 Date of latest renewal: 20 December 2013
Maltese: Data tal-aħħar tiġdid: 20 ta' Diċembru 2013
English: Do not re-use Nplate!
Maltese: Terġax tuża Nplate!
English: Thrombotic/thromboembolic complications
Maltese: Komplikazzjonijiet trombotiċi/tromboemboliċi
English: Additionally, 2.5% (7/282) developed neutralising antibodies to romiplostim.
Maltese: Barra dan, 2.5% (7/282) żviluppaw antikorpi newtralizzanti għal romiplostim.
English: Prior treatments included corticosteroids (98% of all patients), immunoglobulins (97%), rituximab (71%), danazol (37%), cytotoxic therapies (68%), and azathioprine (24%).
Maltese: Trattamenti minn qabel kienu jinkludu kortikosterojdi (98% tal-pazjenti kollha), immunoglobulini (97%), rituximab (71%), danazol (37%), terapiji ċitotossiċi (68%), u azathioprine (24%).
English: • gastroenteritis;
Maltese: • gastroenterite;
English: Placebo (n = 21)
Maltese: Plaċebo (n = 21)
English: A total of 2.2% (4/184) adult patients developed binding, non-neutralising antibody against TPO.
Maltese: Total ta' 2.2% (4/184) talpazjenti adulti żviluppaw antikorpi li jeħlu, mhux newtralizzanti kontra TPO.
English: The volume of distribution of romiplostim following intravenous administration of romiplostim decreased nonlinearly from 122, 78.8, to 48.2 mL/kg for intravenous doses of 0.3, 1.0 and 10 mcg/kg, respectively in healthy subjects.
Maltese: Il-volum ta' distribuzzjoni ta' romiplostim wara għoti ġol-vini naqas b'mod mhux lineari minn 122, 78.8, għal 48.2 mL/kg għal dożi ġol-vini ta' 0.3, 1.0 u 10 mcg/kg, rispettivament, f'individwi f'saħħithom.
English: Multipack: comprising 4 packs Each pack contains:
Maltese: Multipack: fih 4 pakketti
English: Dose in mcg x
Maltese: Doża f'mcg x
English: Prior treatments included corticosteroids (90% of all patients), immunoglobulins (76%), rituximab (29%), cytotoxic therapies (21%), danazol (11%), and azathioprine (5%).
Maltese: Trattamenti minn qabel kienu jinkludu kortikosterojdi (90% tal-pazjenti kollha), immunoglobulini (76%), rituximab (29%), terapiji ċitotossiċi (21%), danazol (11%), u azathioprine (5%).
English: Alcohol intolerance Anorexia
Maltese: Intolleranza għall-alkoħol Anoressija
English: (SD) p-value No. (%) patients requiring rescue therapies d
Maltese: (SD) valur p Numru (%) ta' pazjenti li kellhom bżonn terapiji ta' salvataġġ d
English: Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).
Maltese: Romiplostim huwa magħmul permezz ta' teknoloġija tat-tfassil tad-DNA f'Escherichia coli (E. coli).
English: The median (Q1, Q3) average weekly dose was 4.82 mcg/kg (1.88 mcg/kg, 8.79 mcg/kg).
Maltese: Il-medjan (Q1, Q3) tad-doża medja ta' kull ġimgħa kien ta' 4.82 mcg/kg (1.88 mcg/kg, 8.79 mcg/kg).
English: Generally, dissolution of Nplate takes less than 2 minutes.
Maltese: Ġeneralment, id-dissoluzzjoni ta' Nplate tieħu inqas minn żewġ minuti.
English: The overall safety profile was similar to that seen in adults.
Maltese: Il-profil tas-sigurtà globali kien simili għal dak osservat fl-adulti.
English: See section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials.
Maltese: Ara sezzjoni 4.8 għall-informazzjoni dwar żidiet fir-reticulin osservati fi provi kliniċi ta' romiplostim.
English: 1 sterile safety needle.
Maltese: Labra sterili tas-sigurtà.