FrancophonIA/ELRC3.0 huggingface dataset:
English: Having considered the available evidence in the literature and from individual case safety reports, the PRAC has agreed that the MAH(s) of aripiprazole-containing medicinal products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Maltese: Wara li kkunsidra l-evidenza disponibbli fid-dokumentazzjoni u minn rapporti dwar is-sikurezza ta' każijiet individwali, il-PRAC qabel li d-detentur(i) tal-awtorizzazzjoni għat-tqegħid fuq is-suq (MAH(s)) tal-prodotti mediċinali li fihom aripiprażolu għandu/għandhom jissottometti/jissottomettu varjazzjoni fi żmien xahrejn, sabiex jemenda(w) l-informazzjoni dwar il-prodott kif deskritt hawn taħt (it-test il-ġdid sottolinjat).
English: Frequency ‘not known': aggression
Maltese: Frekwenza mhux magħrufa aggressjoni
English: The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known: Aggression
Maltese: L-effetti sekondarji li ġejjin ġew irrappurtati minn mindu tqiegħed fis-suq l-aripiprażolu orali iżda lfrekwenza ta' kemm-il darba jseħħu mhijiex magħrufa: Aggressjoni
English: PRAC recommendations on signals for update of the product information
Maltese: Rakkomandazzjonijiet tal-PRAC dwar sinjali għallaġġornament tal-informazzjoni dwar il-prodott
English: Summary of Product Characteristics:
Maltese: Sommarju tal-Karatteristiċi tal-Prodott:
English: 0.5 mg Capsule, hard
Maltese: 0.5 mg
English: Bottle (HDPE) 100 capsules
Maltese: 100 kapsula
English: Invented name Strength Pharmaceutical Form Route of administration Packaging Package size
Maltese: <Numru tal-proċedura ta' l-EMEA> <Numru ta' l-EU>
English: EU number
Maltese: Il-pakkett
English: EMA/712450/2015 EMEA/H/C/002302
Maltese: EMEA/H/C/002302
English: Irbesartan/hydrochlorothiazide
Maltese: Irbesartan/idroklorotijażide
English: It is available as tablets (150 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide; 300 mg irbesartan and 12.5 mg hydrochlorothiazide).
Maltese: Jiġi bħala pilloli(150 mg irbesartan u 12.5 mg idroklorotijażide;300 mg irbesartan u 25 mg idroklorotijażide; 300 mg irbesartan u 12.5 mg idroklorotijażide).
English: The full EPAR for Ifirmacombi can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Ifirmacombi jinsab fuq is-sit web tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ifirmacombi on 4 March 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ifirmacombi fl-4 ta' Marzu 2011.
English: Ifirmacombi is a ‘generic medicine'.
Maltese: Ifirmacombi huwa ‘mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Ifirmacombi.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ifirmacombi.
English: Why has Ifirmacombi been approved?
Maltese: Għaliex ġie approvat Ifirmacombi?
English: Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended.
Maltese: Mhuwiex rakkomandabbli doża ogħla minn 300 mg irbesartan u 25 mg idroklorotijażide darba kuljum.
English: The CHMP concluded that, in accordance with EU requirements, Ifirmacombi has been shown to have comparable quality and to be bioequivalent to CoAprovel.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Ifirmacombi għandu kwalità komparabbli u huwa bijoekwivalenti għal CoAprovel.
English: Ifirmacombi is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: Ifirmacombi huwa mediċina li fiha żewġ sustanzi attivi, l-irbesartan u l-idroklorotijażide.
English: Because Ifirmacombi is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel.
Maltese: Minħabba li Ifirmacombi huwa mediċina ġenerika, l-istudji fin-nies kienu limitati għal testijiet sabiex tinstab il-bijoekwivalenza tiegħu għall-mediċina ta' referenza, CoAprovel.
English: Ifirmacombi contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: Ifirmacombi fih żewġ sustanzi attivi, l-irbesartan u l-idroklorotijażide.
English: What are the benefits and risks of Ifirmacombi?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Ifirmacombi?
English: Because Ifirmacombi is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Ifirmacombi huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: What is Ifirmacombi?
Maltese: X'inhu Ifirmacombi?
English: This means that Ifirmacombi is similar to a ‘reference medicine' already authorised in the European Union (EU) called CoAprovel.
Maltese: Dan ifisser li Ifirmacombi huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha CoAprovel.
English: How has Ifirmacombi been studied?
Maltese: Kif ġie studjat Ifirmacombi?
English: Irbesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: L-irbesartan hija tip ta' ‘antagonista tar-riċetturi tal-anġjotensina
English: Rienso ferumoxytol
Maltese: Rienso ferumoksitol
English: The full EPAR for Rienso 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: In all three studies, patients taking Rienso had higher average increases in haemoglobin: 1.2 g/dl versus 0.5 g/dl; 0.8 g/dl versus 0.2 g/dl; and 1.0 g/dl versus 0.5 g/dl.
Maltese: 1.2 g/dl meta mqabbla ma' 0.5 g/dl; 0.8 g/dl meta mqabbla ma' 0.2 g/dl; u 1.0 g/dl meta mqabbla ma' 0.5 g/dl.
English: Rienso is given as an infusion into a vein lasting at least 15 minutes.
Maltese: Rienso jingħata bħala infużjoni fil-vina li ddum mill-inqas 15-il minuta.
English: This is a summary of the European public assessment report (EPAR) for Rienso.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rienso.
English: In studies with Rienso, side effects were seen in 7.9% of patients taking the medicine, of which 0.2% were considered serious.
Maltese: Fl-istudji fuq Rienso, ġew irreġistrati effetti sekondarji f'7.9% tal-pazjenti li kienu qed jieħdu lmediċina, li 0.2% minnhom tqiesu serji.
English: Rienso is an iron preparation that contains the active substance ferumoxytol.
Maltese: Rienso huwa preparazzjoni tal-ħadid li fiha s-sustanza attiva l-ferumoksitol.
English: Other information about Rienso
Maltese: Informazzjoni oħra dwar Rienso
English: It is available as a solution for infusion (drip) into a vein.
Maltese: Jiġi bħala soluzzjoni għallinfużjoni (dripp) fil-vina.
English: The active substance in Rienso, ferumoxytol, is an iron-containing compound.
Maltese: Is-sustanza attiva f'Rienso, il-ferumoksitol, hija kompost li fih il-ħadid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rienso on 15 June 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Rienso valida fl-Unjoni Ewropea kollha fil-15 ta' Ġunju 2012.
English: The most frequently reported side effects were symptoms affecting the gut (diarrhoea, constipation, nausea and vomiting), headache, dizziness and hypotension (low blood pressure), all occurring in less than 2.5% of patients.
Maltese: L-effetti sekondarji serji l-iżjed irrapportati b'mod frekwenti kienu sintomi li jaffettwaw l-imsaren (dijarrea, stitikezza, nawżja u remettar), uġigħ ta' ras, sturdament u ipotensjoni (pressjoni tad-demm baxxa), fejn kollha ġew irreġistrati f'inqas minn 2.5% tal-pazjenti.
English: Rienso is used to treat anaemia (low levels of red blood cells or haemoglobin) caused by a deficiency of iron in patients with chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly).
Maltese: Rienso jintuża għall-kura tal-anemija (livelli baxxi ta' ċelloli ħomor fid-demm jew ta' emoglobina) kkawżata minn defiċjenza ta' ħadid f'pazjenti b'mard kroniku fil-kliewi (tnaqqis progressiv u fit-tul flabbiltà tal-kliewi li jaħdmu sew).
English: What is Rienso?
Maltese: X'inhu Rienso?
English: Serious cases of hypersensitivity (allergic reaction) or hypotension were uncommon and were seen in 0.2% of patients.
Maltese: Każi serji ta' ipersensittività (reazzjoni allerġika) jew ipotensjoni ma kinux komuni u ġew irreġistrati f'0.2% tal-pazjenti.
English: Rienso must not be used in people with a history of drug allergy, including allergy to ferumoxytol or any other iron preparation.
Maltese: Rienso m'għandux jintuża fuq nies bi storja ta' allerġija għall-mediċina, inkluża allerġija għallferumoksitol jew kwalunkwe preparazzjoni oħra tal-ħadid.
English: Three main studies involving 838 chronic kidney disease patients with iron deficiency anaemia have been carried out to compare Rienso with an iron treatment taken by mouth.
Maltese: Saru tliet studji ewlenin li kienu jinvolvu 838 pazjent b'mard kroniku fil-kliewi b'anemija kkawżata minn defiċjenzja tal-ħadid sabiex Rienso jitqabbel ma' kura tal-ħadid meħuda mill-ħalq.
English: Why has Rienso been approved?
Maltese: Għaliex ġie approvat Rienso?
English: A risk management plan has been developed to ensure that Rienso is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Rienso jintuża bl-aktar mod sigur possibbli.
English: Iron deficiency is a common cause of anaemia in patients with long-term kidney disease and is itself caused by many factors including the poor absorption of dietary iron from food.
Maltese: Id-defiċjenza tal-ħadid hija kawża komuni tal-anemija f'pazjenti b'mard fil-kliewi fit-tul u d-defiċjenza nnifisha tiġi kkawżata minn ħafna fatturi, inkluż l-assorbiment insuffiċjenti tal-ħadid djetetiku mill-ikel.
English: The doctor should ensure that the patient is observed for adverse reactions for at least 30 minutes following the infusion.
Maltese: It-tabib għandu jiżgura li l-pazjent ikun osservat minħabba reazzjonijiet avversi għal mill-inqas 30 minuta wara l-għoti tal-infużjoni.
English: How has Rienso been studied?
Maltese: Kif ġie studjat Rienso?
English: What is the risk associated with Rienso?
Maltese: X'inhu r-riskju assoċjat ma' Rienso?
English: Rienso was shown to be superior to iron taken by mouth in treating iron deficiency anaemia in patients with chronic kidney disease.
Maltese: Intwera li Rienso huwa superjuri mill-ħadid li jittieħed mill-ħalq fil-kura tal-anemija kkawżata minn defiċjenza tal-ħadid f'pazjenti b'mard kroniku fil-kliewi.
English: For the full list of all side effects reported with Rienso, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Rienso ara lfuljett ta' tagħrif.
English: Rienso should only be given when healthcare professionals trained to manage anaphylactic (severe allergic) reactions and full resuscitation facilities are available.
Maltese: Rienso għandu jingħata biss meta professjonisti tal-kura tas-saħħa mħarrġa fil-ġestjoni ta' reazzjonijiet anafilattiċi (allerġiji gravi) u faċilitajiet tar-rianimazzjoni sħiħa jkunu disponibbli.
English: The CHMP decided that Rienso's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Rienso huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The main measure of effectiveness was how much haemoglobin levels (measured in grams per decilitre, g/dl) rose after five weeks.
Maltese: Il-kejl ewlieni taleffikaċja kien b'kemm għolew il-livelli tal-emoglobina (imkejla fi grammi għal kull deċilitru, g/dl) wara ħames ġimgħat.
English: When injected into the blood, it is taken up by cells in the liver, spleen and the bone marrow, at which point the iron is released from the compound and replaces the body's depleted iron stores.
Maltese: Skont il-gravità tal-anemija u lpiż tal-ġisem tal-pazjent, tista' tingħata t-tieni infużjoni bejn jumejn u tmint ijiem wara l-ewwel doża.
English: In addition, the company that market Rienso will provide educational material to patients and doctors expected to use Rienso, with information on the risk of allergic reactions.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Rienso fis-suq se tipprovdi materjal edukattiv lill-pazjenti u lit-tobba mistennija li jużaw Rienso, b'informazzjoni dwar ir-riskju ta' reazzjonijiet allerġiċi.
English: What measures are being taken to ensure the safe and effective use of Rienso?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Rienso?
English: 26 March 2010
Maltese: 26 ta' Marzu 2010
English: 1 Article 33(4) of Directive 2001/82/EC, as amended.
Maltese: 1 Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendata.
English: Opinion following an Article 33(4)
Maltese: Opinjoni skond l-Artkolu 33(4)
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was France and the Concerned Member States were Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and United Kingdom.
Maltese: L-applikazzjoni ġiet sottomessa fil-qafas tal-Artikolu 32 tad-Direttiva 2001/82/KE, kif emendata, li fih l-Istat Membru ta' Referenza kien ir-Renju Unit u l-Istati Membri Konċernati kienu l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, idDanimarka, l-Estonja, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, ilLussemburgu, Malta, l-Olanda, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, Spanja u r-Renju Unit.
English: The Rapporteur and Co-Rapporteur appointed were: Dr A. Holm and Dr B. Kolar, respectively.
Maltese: Holm u Dr B. Kolar, rispettivament.
English: The Decentralised Procedure FR/V/195/01/DC started on 29 February 2008.
Maltese: Il-Proċedura Diċentralizzata FR/V/195/01/DC bdiet fid-29 ta' Frar 2008.
English: EMA/115640/2010
Maltese: EMA/115640/2010 kumitat għall-prodotti mediċinali għall-użu veterinarju (CVMP)
English: The final opinion was converted into a Decision by the European Commission on 26 March 2010.
Maltese: L-opinjoni finali nqalbet f'Deċiżjoni mill-Kummissjoni Ewropea fi 26 ta' Marzu 2010.
English: referral for CEVAZURIL 50 mg/ml oral suspension for piglets
Maltese: 1referenza għal CEVAZURIL 50 mg/ml sospenzjon orali għal qżieqeż żgħar
English: The Applicant, Ceva Santé Animale, submitted an application for a decentralised procedure for CEVAZURIL 50 mg/ml oral suspension for piglets.
Maltese: L-Applikant, Ceva Santé Animale, issotometta applikazzjoni għal proċedura diċentralizzata għal CEVAZURIL 50 mg/ml sospenzjoni orali għal qżieqeż żgħar.
English: On 6 May 2009 France, referred the matter to the Agency under Article 33(4) of Directive 2001/82/EC, due to concerns, raised by Germany, Spain, Portugal, Poland and the United Kingdom, that the marketing authorisation of CEVAZURIL 50 mg/ml oral suspension for piglets may present a potential serious risk to the environment.
Maltese: Fis-6 ta' Mejju 2009 Franza, rreferiet il-kwistjoni lill-Aġenzija skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE, minħabba tħassib, imqajjem mill-Ġermanja, Spanja, il-Portugall, il-Polonja u r-Renju Unit, li l-awtorizzazzjoni għat-tqegħid fis-suq għal CEVAZURIL 50 mg/ml ta' sospensjoni orali għal qżieqeż żgħar tista' tippreżenta riskju serju u potenzjali għall-ambjent.
English: The referral procedure started on 12 May 2009.
Maltese: Il-proċedura ta' referenza bdiet fit-12 ta' Mejju 2009.
English: Toltrazuril is a triazinon derivative administered orally to piglets for the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora suis.
Maltese: Toltrazuril huwa derivattiv ta' triazinonindikat amministrat oralment fi qżieqeż żgħar għall-prevenzjoni ta' sinjali kliniċi ta' kokkidijożi fi ħnienes li jkunu għadhom kif twieldu f'irziezet bi storja kkonfermata ta' kokkidożi kkawżata minn Isospora sui.
English: Oral explanations were given on 8 December 2009.
Maltese: Spjegazzjonijiet orali ġew mogħtija fit-8 ta' Diċembru 2009.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, on 9 December 2009 the CVMP considered that the objections raised during the decentralised procedure should not prevent the granting of a Marketing Authorisation for CEVAZURIL 50 mg/ml oral suspension for piglets.
Maltese: Fuq il-bażi tal-evalwazzjoni tal-valutazzjoni tar-rapporteur tal-informazzjoni attwalment disponibbli, fid-9 ta' Diċembru 2009 il-CVMP ħass li l-oġġezzjonijiet imqajjma matu il-proċedura diċentralizzata ma għandhomx jipprevjenu l-Awtorizzazzjoni għat-Tqegħid fis-Suq għal CEVAZURIL 50 mg/ml sospenzjoni orali għal qżieqeż żgħar.
English: Strengths available are 250 mg, 500 mg, 1g and 2g.
Maltese: Il-qawwiet disponibbli huma 250 mg, 500 mg, 1g u 2g.
English: Intra-abdominal infections (IAI)
Maltese: Infezzjonijiet intra-addominali (IAI)
English: Acute otitis media (AOM)
Maltese: Otite medja akuta (AOM)
English: Bacterial endocarditis
Maltese: Endokardite batterika
English: • Acute exacerbations of chronic bronchitis (AECB)
Maltese: • Taħrix akut ta' bronkite kronika (AECB)
English: Syphilis including neurosyphilis
Maltese: Sifilide inkluż newrosifilide
English: Gonorrhoea, gonococcal arthritis, gonococcal eye infection
Maltese: Gonorrea, artrite gonokokkali, infezzjoni gonokokkali fl-għajnejn
English: Urinary tract infections (UTI), including pyelonephritis
Maltese: Infezzjonijiet tal-apparat urinarju (UTI), inkluż pajelonefrite
English: Solvent vials contain either sterile water for injections or 1% lidocaine hydrochloride solution.
Maltese: Kunjetti tas-solvent fihom jew ilma sterili għall-injezzjonijiet jew soluzzjoni ta' 1% lidocaine hydrochloride.
English: Ceftriaxone is not metabolised systemically; but is converted to inactive metabolites by the gut flora.
Maltese: Ceftriaxone ma jiġix metabolizzat b'mod sistemiku; iżda jiġi konvertit f'metaboliti inattivi mill-flora tal-imsaren.
English: Lyme Borreliosis
Maltese: Borreljożi ta' Lyme
English: Adverse events such biliary lithiasis, biliary stasis and renal lithiasis have also been included with a cross reference to section 4.8 (undesirable effects).
Maltese: Avvenimenti avversi bħal lithiasis biljari, stasi biljari u lithiasis renali ġew inklużi wkoll b'referenza inkroċjata għal sezzjoni 4.8 (effetti mhux mixtieqa).
English: Bacteraemia
Maltese: Batterimja
English: Rocephin contains ceftriaxone, a cephalosporin antibacterial agent with in-vitro activity against a range of Gram-positive and Gram-negative bacteria.
Maltese: Rocephin fih ceftriaxone, aġent antibatteriku ta' sefalosforin b'attività in-vitro kontra firxa ta' batterji Gram-pożittivi u Gram-negattivi.
English: Information on absorption, distribution, metabolism and elimination has been provided.
Maltese: Informazzjoni dwar l-assorbiment, id-distribuzzjoni, il-metaboliżmu u l-eliminazzjoni ġiet ipprovduta.
English: In addition the draft addendum to the Note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) refers to IAI only.
Maltese: Barra minn hekk labbozz tal-addendum għan-Nota għall-gwida dwar il-valutazzjoni ta' prodotti mediċinali indikati għall-kura ta' infezzjonijiet batteriċi (CPMP/EWP/558/95 rev 2) jirreferi għal IAI biss.
English: The most frequently reported adverse reactions for Rocephin are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and increased hepatic enzymes.
Maltese: L-aktar reazzjonijiet avversi rrapportati b'mod frekwenti għal Rocephin huma eosinofilja, lewkopenja, tromboċitopenja, dijarea, raxx, u żieda fl-enzimi epatiċi.
English: Rocephin is approved in 19 EU Member States with different nationally approved Summaries of Product Characteristics (SmPCs).
Maltese: Rocephin huwa approvat fi 19-il Stat Membru tal-UE b'Sommarji tal-Karatteristiċi talProdott (SmPCs) differenti approvati fuq livell nazzjonali.
English: Prophylaxis of perioperative infections
Maltese: Profilassi ta' infezzjonijiet perioperattivi
English: Section 4.5- Interaction with other medicinal products and other forms of interaction In order to comply with the Guideline on the Summary of product Characteristics, the statement mentioning incompatibilities with amsacrine, vancomycin, fluconazole & aminoglycosides (which is included in the EU CSP) has been moved to Section 6.2 (Incompatibilities).
Maltese: Sabiex tkun konformi mal-Linja Gwida dwar is-Sommarju tal-Karatteristiċi tal-prodott, iddikjarazzjoni li ssemmi inkompatibiltajiet ma' amsacrine, vancomycin, fluconazole u aminoglycosides (li hija inkluża fis-CSP tal-UE) tressqet għas-Sezzjoni 6.2 (Inkompatibilitajiet).
English: There is evidence for the efficacy of ceftriaxone in the perioperative prophylaxis of infections in several types of surgery such as cardiac surgery, orthopaedic surgery, genitourinary surgery and transurethral resection of the prostate (TURP).
Maltese: Hemm evidenza għall-effikaċja ta' ceftriaxone fil-profilassi perioperattiva ta' infezzjonijiet f'bosta tipi ta' kirurġija bħal kirurġija tal-qalb, kirurġija ortopedika, kirurġija ġenitourinarja u risezzjoni transuretrali tal-prostata (TURP).
English: Dose recommendations have been listed in tabular format according to dosage schedules for each indication for: Adults and children over 12 years of age (≥ 50 kg), Neonates, infants and children 15 days to 12 years of age (< 50 kg) and Neonates 0-14 days.
Maltese: Ir-rakkomandazzjonijiet tad-dożi ġew elenkati f'format tabulari skont skedi ta' dożaġġ għal kull indikazzjoni għal: Adulti u tfal ta' aktar minn 12-il sena (≥ 50 kg), Trabi tat-twelid, trabi u tfal minn 15-il jum sa 12-il sena (< 50 kg) u Trabi tat-twelid minn 0-14-il jum.
English: The MAH's proposed text was accepted with minor re-wording.
Maltese: It-test propost tal-MAH kienet aċċettat b'riformulazzjoni minuri.
English: Ceftriaxone has been used as a comparator in several recently conducted clinical trials of newer antibacterial medicinal products including ceftaroline and ceftobiprole.
Maltese: Ceftriaxone ġie użat bħala komparatur f'diversi provi kliniċi li saru reċentement ta' prodotti mediċinali antibatteriċi ġodda fosthom ceftaroline u ceftobiprole.
English: One paediatric study was also submitted by the MAH, which enrolled 48 patients aged 2 months to 5 years.
Maltese: Il-MAH ippreżenta wkoll studju pedjatriku wieħed, li fih ħadu sehem 48 pazjent bejn xahrejn u 5 snin.
English: The elimination half-life of total ceftriaxone in adults is about 8 hours.
Maltese: Il-half-life tal-eliminazzjoni ta' ceftriaxone totali fl-adulti hija ta' madwar 8 sigħat.
English: Ceftriaxone is eliminated unchanged renally (by glomerular filtration) and biliary secretion.
Maltese: Ceftriaxone jiġi eliminat mhux mibdul mill-kliewi (permezz ta' filtrazzjoni glomerulari) u sekrezzjoni biljari.
English: Ceftriaxone distributes primarily into the extracellular space.
Maltese: Ceftriaxone jiddistribwixxi primarjament fl-ispazju ekstraċellulari.
English: Ceftriaxone has been shown to be beneficial in both early (Stage II) and late (Stage III) disseminated Lyme borreliosis and is recommended in current clinical guidelines.
Maltese: Ceftriaxone intwera li kien ta' benefiċċju kemm fl-istadju bikri (Stadju II) u fl-istadju tard (Stadju III ) ta' borreljożi ta' Lyme disseminat u huwa rakkomandat f'linji gwida kliniċi attwali.