FrancophonIA/ELRC3.0 huggingface dataset:
English: In this study, patients were prescribed 20 mg/kg, 25 mg/kg, 40 mg/kg or 50 mg/kg daily dose of oral solution based on their age titration schedule.
Maltese: F'dan l-istudju, il-pazjenti ġew mogħtija dożi ta' kuljum ta' 20 mg/kg, 25 mg/kg, 40 mg/kg jew 50 mg/kg ta' soluzzjoni orali bbażati fuq l-iskeda tat-titrazzjoni skond l-eta`.
English: The possible side effects of an overdose of Matever are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Maltese: Wara dożi eċċessivi ta' Matever, ġew osservati effetti ta' ħedla, aġitazzjoni, aggressjoni, tnaqqisfillivell ta' kuxjenza, livell baxx tar-rifless respiratorju, u koma.
English: EU/1/11/711/023 EU/1/11/711/024 EU/1/11/711/025 EU/1/11/711/026 EU/1/11/711/027 EU/1/11/711/028 EU/1/11/711/029
Maltese: EU/1/11/711/026 EU/1/11/711/027 EU/1/11/711/028 EU/1/11/711/029
English: Creatinine clearance (ml/min/1.73 m
Maltese: Rata ta' tneħħija talkrejatinina (ml/min/1.73 m
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Maltese: Ebda effett mhux mixtieq fuq il-fertilita` maskili jew femminili jew abbilta` riproduttiva ma kienu osservati fil-firien f'dożi sa 1800 mg/kg/day (x 6 l-MRHD fuq bażi ta' mg/m2 jew t'esponiment) fil-ġenituri u l-ġenerazzjoni F1.
English: Matever 100 mg/ml concentrate for solution for infusion
Maltese: Matever 100 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: Matever concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Maltese: Il-konċentrat Matever huwa għall-użu minn ġol-vina biss u d-doża rikkmandata trid tiġi dilwita f' millinqas 100 ml ta' dilwent kompattibli u tingħata b'infużjoni minn ġol-vina fuq medda ta' 15 il-minuta (ara sezzjoni 6.6).
English: What Matever looks like and contents of the pack
Maltese: Id-dehra ta' Matever u d-daqs tal-pakkett
English: • 1000 mg: 10, 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.
Maltese: • 1000 mg: 10, 20, 30, 50, 60, 100 u pakkett b'ħafna ta' 200 (2 pakketti b'100) pillola miksija b'rita.
English: This medicine contains 57.21 mg sodium (main component of cooking/table salt) in each maximum single dose.
Maltese: Din il-mediċina fiha 57.21 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir / li jintuża mal-ikel) f'kull doża singola massima waħda.
English: България ACEpharma Ltd.
Maltese: Id-doża totali kuljum u l-frekwenza tibqa l-istess.
English: • 250 mg: 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.
Maltese: • 250 mg: 20, 30, 50, 60, 100 u pakkett b'ħafna ta' 200 (2 pakketti b'100) pillola miksija b'rita.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea għallil-mediċini http://www.ema.europa.eu
English: Add-on therapy for infants aged from 1 month to less than 6 months
Maltese: Terapija għat-trabi b'età minn xahar 1sa inqas minn 6 xhur
English: The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighting 50 kg or more, the following formula:
Maltese: Din ir-rata tista' tigi kkalkulata mill-livell ta' krejatinina fis-serum (mg/dl), għal adulti u addoloxenti ta' 50 kg jew aktar, billi tuża din il-formula:
English: • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Maltese: • Waħdu f'adulti u addoloxxenti minn 16 il-sena b'epilessija li għadha kif ġiet iddijanjostikata, fittrattament ta' ċertu forma ta' epilessija.
English: • Dextrose 5 % injection
Maltese: injezzjoni ta' Lactated Ringer injezzjoni ta' Dextrose 5%
English: 3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
Maltese: 5 mg/kg (0.035 sa 0.105 ml/kg)darbtejn kuljum
English: 250 mg 2.5 ml (half 5 ml vial)
Maltese: Doża totali ta' kuljum250 mg 2.5 ml (nofs vjala ta' 5 ml) 100 ml 15 minuti Darbtejn kuljum
English: A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: (3) Doża kbira ta' 15 mg/kg (0.15 ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults.
Maltese: Ir-riżultati ta' sigurta` f'pazjenti pedjatriċi f'studji kkontrollati bil-plaċebo kienu konsistenti mal-profil ta' sigurta` ta' levetiracetam fl adulti ħlief għar-reazzjonijiet avversi ta' mġieba u psikjatriċi li kienu iżjed komuni fit-tfal milli fladulti.
English: • Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Maltese: • Dożaġġ fit-trabi ( 1 xahar sa 23 xahar), fit-tfal (2 sa 11 il-sena) u addoloxxenti (12 sa 17 ilsena) li jiżnu inqas minn 50 kg:
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to<1/100); rare (≥1/10,000 to<1/1,000) and very rare (<1/10,000)
Maltese: Reazzjonijiet avversi huma mniżżla skont isserjetà u l-frekwenza tagħhom hija definita kif ġej: komuni hafna (≥1/10); komuni: (>1/100 sa 1/10); mhux komuni: (>1/1,000 sa 1/100); rari:
English: Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Maltese: Wara id-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 5 u 10 mg/kg (0.05 sa 0.10 ml/kg).
English: Somnolence, headache
Maltese: Diplopja, viżjoni mċajpra
English: Coating agent (yellow) consisting of: Hydroxypropylcellulose (E463) Hypromellose (E464) Propylene glycol (E1520) Quinoline yellow aluminium lake (E104) Sorbic acid (E200)
Maltese: Aġent għall-kisin (isfar) li jikkonsisti minn: Hydroxypropylcellulose (E463) Hypromellose (E464)
English: Two embryo-fetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day.
Maltese: Żewġt studji fuq l-iżvillup ta' l-embriju u l-fetu (EFD) saru fil-far b' 400, 1200 u 3600 mg/kg/ġurnata.
English: Infants 6 to 23 months, children and adolescents weighing less than 50 kg
Maltese: Trabi ta' bejn 6 sa 23-il xahar, tfal u addoloxenti li jiżnu inqas minn 50 kg
English: Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Maltese: Dan it-tagħrif jissuġġerixxi li l-interazzjoni bejn levtiracetam u l-proteina talbużżieqa tas-sinapsi 2A donnhom jikkontribwixxu għall-mekkaniżmu t'azzjoni kontra l-epilessija talprodott mediċinali.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Maltese: (≥1/10,000 sa 1/1,000) u rari ħafna: (≤1/10,000).
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 20, 30, 50, 60, 80, 100, 120 and multipack containing 200 (2 packs of 100) film-coated tablets.
Maltese: Folji ta' l-aluminju/PVC/PE/PVDC u mqegħda f' kaxxi tal-kartun ta' 20, 30, 50, 60, 80, 100, 120 u pakkett b'ħafna fih 200 (2 pakketti b'100) pillola miksija b'rita.
English: Add-on therapy for infants and children less than 4 years
Maltese: Terapija miżjuda fi trabi u tfal ta'inqas minn eta`ta' 4snin
English: A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: 5 mg/kg (0.105 ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: Matever 250 mg film-coated tablets
Maltese: Matever 250 mg pilloli miksija b'rita
English: EU/1/11/711/007 EU/1/11/711/008 EU/1/11/711/009 EU/1/11/711/010 EU/1/11/711/011 EU/1/11/711/012 EU/1/11/711/013 EU/1/11/711/014
Maltese: EU/1/11/711/007 EU/1/11/711/008 EU/1/11/711/009 EU/1/11/711/010
English: 500 mg 5 ml (one 5 ml vial)
Maltese: 500 mg 5 ml (vjala waħda ta' 5 ml) 100 ml 15 minuti Darbtejn kuljum
English: Box of 10 vials
Maltese: Kull kaxxa tal-kartun fiha 10 vjali.
English: The patients were randomized to carbamazepine CR 400 -1200 mg/day or levetiracetam 1000 -3000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Maltese: Il-pazjenti kienu maqsuma mingħajr ma ġew magħżula biex jieħdu jew carbamazepine CR 400 - 1200 mg/ġurnata jew levetiracetam 1000 - 3000 mg/ġurnata, b'trattament li dam sa 121 ġimgħa skond kemm kien ir-rispons.
English: • Risk management plan (RMP) Not applicable.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse reactions seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x 6-17 the MRHD on a mg/m2 basis)
Maltese: Studji fl-annimali tat-twelid u ġovanili fil-firien u l-klieb wrew li ma kienx hemm effetti avversi filpunti tat-tmiem standard tal-iżvillup jew maturazzjoni b'dożi sa 1800 mg/kg/ġurnata ( x6 - 17 ilMRHD fuq bażi ta' mg/m
English: Matever 500 mg film-coated tablets
Maltese: Matever 500 mg pilloli miksija b'rita
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and multipack containing 200 (2 packs of 100) film-coated tablets.
Maltese: Folji ta' l-aluminju/PVC/PE/PVDC u mqegħda f' kaxxi tal-kartun ta' 10, 20, 30, 50, 60, 100, 120 u pakkett b'ħafna fih 200 (2 pakketti b'100) pillola miksija b'rita.
English: • a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
Maltese: • Raxx iżjed severa li tikkawża t-tqaxxir tal-ġilda f'iżjed minn 30% tal-wiċċ tal-ġilda (nekrożi tossika epidermali)
English: However, based on the pharmacokinetic characteristics of levetiracetam, the pharmacokinetics in adults after intravenous administration and the pharmacokinetics in children after oral administration, the exposure (AUC) of levetiracetam is expected to be similar in paediatric patients aged 4 to 12 years after intravenous and oral administration.
Maltese: Imma bbażat fuq il-karatteristiċi farmakokinetiċi ta' levetiracetam, il-farmakokinetika fl-adulti wara li jingħata minn ġol-vina u l-farmakokinetika fit-tfal wara amministrazzjoni orali, l-esponiment (AUC) ta' levetiracetam huwa mistenni li jkun l-istess fil-pażjenti pedjatriċi ta' eta` minn 4 sa 12 snin wara li jittieħed minn ġol-vina u minn ġol-ħalq.
English: Matever 1000 mg film-coated tablets
Maltese: Matever 1000 mg pilloli miksija b'rita
English: • flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
Maltese: • Sintomi bħal ta' riħ u raxx fuq il-wiċċ segwit minn raxx mifrux b'temperatura għaolja, żieda fillivelli tal-enżimi tal-fwied murija f' testijiet tad-demm u żieda f' tip ta' ċellola tad-demm bajda (esinofilja) u tkabbir fin-nodi limfatiċi (Reazzjoni tad-Droga b' Esinofilja u Sintomi Sistemiċi [DRESS])
English: The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1500 mg intravenous infusion for 4 days with twice daily dosing.
Maltese: Il-profil farmakokinetiku li huwa indipendenti mill-ħin kien ikkonfermat wkoll wara infużjoni minn ġol-vina ta' 1500 mg għal 4 ijiem b' doża b.i.d.
English: Each film-coated tablet contains 1000 mg levetiracetam.
Maltese: Kull pillola miksija b'rita fiha 1000 mg levetiracetam.
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks).
Maltese: Jekk levetiracetam għandu jitwaqqaf hu rrikkmandat li jitwaqqaf gradwalment (ez. f ` adulti u adoloxxenti li jiżnu iżjed minn 50 kg: tnaqqis ta' 500 mg darbtejn kuljum kull ġimagħtejn sa erba' ġimgħat; fi tfal u adoloxxenti li jiżnu inqas minn 50 kg: it-tnaqqis fid-doża m'għandiex taċċedi 10 mg/kg darbtejn kuljum kull ġimagħtejn).
English: Vial of 5 ml
Maltese: Ż-ŻGĦAR EWLENIN vjala ta' 5 ml
English: • as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
Maltese: • fit-trattament ta' aċċessjonijiet tat-tip parzjali kemm meta jkun hemm, kif ukoll meta ma jkunx hemm ġeneralizzazzjoni sekondarja adulti, addoloxxenti u tfal minn 4 snin b'epilessija.
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100 and multipack containing 200 (2 packs of 100) film-coated tablets.
Maltese: Folji ta' l-aluminju/PVC/PE/PVDC u mqegħda f' kaxxi tal-kartun ta' 10, 20, 30, 50, 60, 100 u pakkett b'ħafna fih 200 (2 pakketti b'100) pillola miksija b'rita.
English: Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Maltese: Terapija miżjuda fit-trattament ta' aċċessjonijiet mijokloniċi f'adulti u addoloxxenti min 12 il-sena b'epilessija mijoklonika li tibda fiż-żgħożija.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens
Maltese: • raxx fil-ġilda, li jista' jifforma bżieżaq u li jidher qisu targi żgħar (tikek ċentrali skuri mdawwra b'erja iżjed pallida, b'ċirku skur mat-tarf) (erythema multiforme), raxx diffuz bil-bżieżaq u ġilda li titqaxxar, partikolarrment madwar il-ħalq, mnieħer, għajnejn u l-ġenitali (sindrome ta'
English: 3 years.
Maltese: 3.5 sa 10.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Maltese: Dan il-prodott mediċinali ma' jistax jiġi dilwit ma' prodotti oħra mediċinali għajr dawk imsemmija f'sezzjoni 6.6.
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy:
Maltese: Terapija miżjuda fit-trattament ta' aċċessjonijiet tat-tip parzjali kemm b'ġeneralizazzjoni sekondarja kif ukoll mingħajr f'adulti, addoloxxenti u tfal minn 4 snin b'epilessija:
English: Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels.
Maltese: It-teħid flimkien ta' levetiracetam u methotrexate kien irrapurtat li jnaqqas it-tneħħija ta' methotrexate, li jirriżulta f żieda / imtawwal ta' konċentrazzjoni fid-demm ta' methotrexate f'livelli potenzjalment tossiċi.
English: Matever 1000 mg film-coated tablets levetiracetam2.
Maltese: Matever 1000 mg pilloli miksija b'rita fih il-lattożju.
English: Core
Maltese: Severa
English: Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes.
Maltese: It-tneħħija ta' levetiracetam fit-tfal kienet 30 % iżjed minn dik f'adulti li jbatu mill-epilessija meta ġiet ikkonsidrata d-differenza fil-piż.
English: Matever concentrate is an alternative for patients when administration of the antiepileptic oral Matever medicine is temporarily not feasible.
Maltese: Il-konċentrat Matever huwa alternattiva għal pazjenti li temporanjament ma' jistgħux jieħdu mediċina mill-ħalq.
English: Matever 250 mg, 750 mg film-coated tablets contain E110 colouring agent which may cause allergic reactions.
Maltese: Matever 250 mg, 750mg pilloli miksija b'rita fih is-sustanza li tagħti l-kulur E110 li tista tikkawża reazzjonijiet allerġiċi.
English: • if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal levetiracetam, derivattivi ta' pyrrolidonejew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: EMA/482554/2014 EMEA/H/C/001209
Maltese: EMEA/H/C/001209
English: It is available as capsules (4 and 8 mg).
Maltese: Jiġi f'kapsuli (4 u 8 mg).
English: The full EPAR for Silodyx can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Silodyx, silodosin, is an alpha adrenoreceptor antagonist.
Maltese: Is-sustanza attiva f'Silodyx, is-silodosin, hija antagonista alfaadrenoċettur.
English: Silodyx is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Maltese: Silodyx jintuża għall-kura tas-sintomi ta' iperplasija beninna tal-prostata (Benign Prostatic Hyperplasia - BPH, glandola tal-prostata mkabbra) fl-adulti.
English: This is a summary of the European public assessment report (EPAR) for Silodyx.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Silodyx.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Silodyx on 29 January 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Silodyx valida fl-Unjoni Ewropea kollha fid-29 ta' Jannar 2010.
English: Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery.
Maltese: Is-sindromu tal-iris mitluqa waqt operazzjoni (Intra-operative floppy iris syndrome - IFIS) iseħħ f'xi pazjenti li jkunu qegħdin jieħdu antagonisti alfaadrenoċetturi u jista' jwassal għal komplikazzjonijiet waqt operazzjoni tal-katarretti.
English: For men with moderate kidney problems, the starting dose should be 4 mg once a day.
Maltese: Għall-irġiel bi problemi moderati tal-kliewi, id-doża tal-bidu għandha tkun 4 mg darba kuljum.
English: In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Silodyx after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.
Maltese: Fit-tielet studju, l-IPSS kien madwar 19-il punt qabel il-kura, u naqas b'7.0 punti fl-irġiel li ħadu Silodyx wara 12-il ġimgħa, 6.7 punti fl-irġiel li ħadu tamsulosin u 4.7 punti fl-irġiel li ħadu plaċebo.
English: After 12 weeks, it had fallen by around 6.4 points in the men who took Silodyx, and by around 3.5 points in the men who took placebo.
Maltese: Wara 12-il ġimgħa, kien naqas b'madwar 6.4 punti fl-irġiel li ħadu Silodyx, u b'madwar 3.5 punti flirġiel li ħadu plaċebo.
English: The recommended dose is one 8 mg capsule once a day.
Maltese: Id-doża rakkomandata hija kapsula ta' 8 mg waħda kuljum.
English: Silodyx is a medicine that contains the active substance silodosin.
Maltese: Silodyx huwa mediċina li fiha s-sustanza attiva silodosin.
English: Other information about Silodyx
Maltese: Informazzjoni oħra dwar Silodyx
English: Silodyx has been compared with placebo (a dummy treatment) in three main studies involving over 1,800 men with BPH.
Maltese: Silodyx tqabbel ma' plaċebo (kura finta) fi tliet studji ewlenin li kienu jinvolvu aktar minn 1,800 raġel b'BPH.
English: What is the risk associated with Silodyx?
Maltese: X'inhu r-riskju assoċjat ma' Silodyx?
English: When these receptors are activated, they cause the muscles controlling the flow of urine to contract.
Maltese: Meta dawn ir-riċetturi jiġu attivati, iġiegħlu lill-muskoli li jikkontrollaw il-fluss tal-awrina jinġibdu.
English: Why has Silodyx been approved?
Maltese: Għaliex ġie approvat Silodyx?
English: What is Silodyx?
Maltese: X'inhu Silodyx?
English: The most common side effect with Silodyx (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation.
Maltese: L-effett sekondarju l-aktar komuni li deher b'Silodyx (li deher f'iktar minn pazjent 1 minn kull 10) huwa tnaqqis fl-ammont ta' semen li joħroġ waqt l-eġakulazzjoni.
English: In the two studies where Silodyx was compared only with placebo, the IPSS was around 21 points at the start of the study.
Maltese: Fiżżewġ studji fejn Silodyx tqabbel ma' plaċebo biss, l-IPSS kien madwar 21 punt fil-bidu tal-istudju.
English: One of these studies also compared Silodyx with tamsulosin (another medicine used for BPH).
Maltese: Wieħed minn dawn l-istudji qabbel ukoll Silodyx ma' tamsulosin (mediċina oħra li tintuża għal BPH).
English: By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.
Maltese: Silodyx kien aktar effikaċi minn plaċebo u effikaċi daqs tamsulosin fit-tnaqqis tas-sintomi ta' BPH.
English: The effects of Silodyx were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Silodyx għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: A risk management plan has been developed to ensure that Silodyx is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Silodyx jintuża bl-aktar mod sigur possibbli.
English: It works by blocking receptors called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body).
Maltese: Taħdem billi timblokka riċetturi msejħin alfaadrenoċetturi 1A fil-glandola tal-prostata, fil-bużżieqa tal-awrina u fl-uretra (il
English: What measures are being taken to ensure the safe and effective use of Silodyx?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Silodyx?
English: In addition, the company that makes Silodyx will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.
Maltese: Barra minn hekk, il-kumpanija li tagħmel Silodyx se tiżgura li l-kirurgi tal-għajnejn jiġu pprovduti b'informazzjoni dwar l-IFIS fl-Istati Membri kollha fejn il-mediċina sejra titqiegħed fis-suq.
English: When enlarged, it can cause problems with the flow of urine.
Maltese: Meta tikber, tista' tikkawża problemi fil-fluss tal-awrina.
English: MA (EU) Numbers
Maltese: Numru ta' l-EU
English: ANNEX IV
Maltese: Anness IV
English: • Circulate the DHPC agreed upon with the CHMP, in accordance with the agreed communication plan.
Maltese: • Jiċċirkolaw id-DHPC miftiehem mas-CHMP, skont il-pjan ta' komunikazzjoni miftiehem.
English: • Shorten the PSUR cycle to an annual submission
Maltese: • Inaqqsu ċ-ċiklu tal-PSUR għal sottomissjoni annwali
English: • Conduct a drug utilisation study (DUS) to monitor the effectiveness of the risk minimisation measures.
Maltese: • Iwettqu studju dwar l-użu tal-mediċina (DUS) biex jimmonitorjaw l-effikaċja tal-miżuri għallminimizzazzjoni tar-riskju.