FrancophonIA/ELRC3.0 huggingface dataset:
English: Memantine Mylan 20 mg film-coated tablets memantine hydrochloride
Maltese: Memantine Mylan 20 mg pilloli miksijin b'rita memantine hydrochloride
English: The effects of barbiturates and neuroleptics may be reduced.
Maltese: L-effetti ta' barbiturati u newrolettiċi jistgħu jiddgħajjfu.
English: Memantine Mylan 10 mg film-coated tablets memantine hydrochloride
Maltese: Memantine Mylan 10 mg pilloli miksijin b'rita memantine hydrochloride
English: one and a half 10 mg tablets week 4 and beyond one 20 mg tablet once a day
Maltese: pillola waħda u nofs ta' 10 mg minn ġimgħa 4 'l quddiem pillola waħda ta' 20 mg darba kuljum
English: In patients with mildly impaired renal function (creatinine clearance 50 - 80 ml/min) no dose adjustment is required.
Maltese: F'pazjenti b'funzjoni renali indebolita b'mod ħafif (tneħħija tal-kreatinina 50-80 ml/min) m'hemmx bżonn li tinbidel id-doża.
English: • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Maltese: L-użu ta' memantine u amantadine għandu jkun evitat, minħabba r-riskju ta' psikożi farmakotossika.
English: 56 x 1 film-coated tablets 60 film-coated tablets
Maltese: 56 × 1 pillola miksija b'rita 60 pillola miksija b'rita 70 pillola miksija b'rita 84 pillola miksija b'rita.
English: Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Maltese: Minbarra hekk, il-pH ta' l-awrina tista' titla minħabba każijiet ta' aċidożi tubulari renali (RTA) jew infezzjonijiet severi tal-passaġġ awrinarju b'batterji Proteus.
English: Memantine Mylan 20 mg film-coated tablets
Maltese: Memantine Mylan 20 mg pilloli miksijin b'rita.
English: Marketing Authorisation Holder
Maltese: Doża ta' manteniment
English: NAME OF THE MEDICINAL PRODUCT Memantine Mylan 20 mg film-coated tablets memantine hydrochloride
Maltese: TAL-PRODOTT MEDIĊINALI Memantine Mylan 20 mg pilloli miksijin b'rita memantine hydrochloride
English: What Memantine Mylan looks like and contents of the pack A red film-coated, oval, biconvex, beveled edge tablet marked with “ME” on one side of the tablet and “20” on the other side.
Maltese: Kif jidher Memantine Mylan u l-kontenut tal-pakkett Pillola miksija b'rita ta' kulur aħmar, b'tarf ġej għal xejn xejn, bikonvessa, immarkata b'“ME” fuq naħa waħda tal-pillola u “20” fuq in-naħa l-oħra.
English: The maximum daily dose is 20 mg per day.
Maltese: Id-doża rakkomandata hi ta' 20 mg kuljum.
English: one and a half 10 mg tablets week 4 and beyond two 10 mg tablets once a day
Maltese: pillola waħda u nofs ta' 10 mg minn ġimgħa 4 'l quddiem żewġ pilloli waħda ta' 10 mg darba kuljum
English: Tablet coat for 10/20 mg film-coated tablets: Polydextrose (E1200)
Maltese: Polydextrose (E1200)
English: UK
Maltese: Ngħas
English: 98 film-coated tablets
Maltese: 98 pillola miksija b'rita.
English: NAME OF THE MEDICINAL PRODUCT Memantine Mylan 10 mg film-coated tablets memantine hydrochloride
Maltese: TAL-PRODOTT MEDIĊINALI Memantine Mylan 10 mg pilloli miksijin b'rita memantine hydrochloride
English: None of these metabolites exhibit NMDA-antagonistic activity.
Maltese: L-ebda wieħed minn dawn il-metaboli m'għandu attività antagonista għal NMDA.
English: What Memantine Mylan looks like and contents of the pack A dark yellow film-coated, tapered oblong shaped, biconvex tablet marked with “ME” on the left of the score and “10” on the right of the score on one side of the tablet and a score on the other side.
Maltese: Kif jidher Memantine Mylan u l-kontenut tal-pakkett Pillola miksija b'rita ta' kulur isfar skur, b'forma oblunga b'tarf ġej għal xejn xejn, bikonvessa, immarkata b'“ME” fuq in-naħa tax-xellug tas-sinjal minn fejn tista' taqsam u “10” fuq in-naħa tallemin tas-sinjal minn fejn tista' taqsam fuq naħa waħda tal-pillola u sinjal minn fejn tista' taqsam fuq in-naħa l-oħra.
English: If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Maltese: Jagħmel parti minn grupp ta' mediċini magħrufa bħala mediċini kontra d-dimenzja.
English: Continue to take Memantine Mylan as long as it is of benefit to you.
Maltese: Kompli ħu Memantine Mylan sakemm tibqa' tikseb benefiċċju.
English: Fertility No adverse reactions of memantine were noted on male and female fertility.
Maltese: Fertilità L-ebda reazzjonijiet avversi ta' memantine ma ġew osservati fuq il-fertilità tal-irġiel u n-nisa.
English: Memantine Mylan belongs to a group of medicines called NMDAreceptor antagonists.
Maltese: Memantine Mylan jagħmel parti minn grupp ta' mediċini li jissejħu antagonisti tar-riċettur-NMDA.
English: Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Maltese: Il-pazjent għandu jieħu nofs pillola miksija b'rita ta' 10 mg kuljum (5 mg) għal 7 t'ijiem.
English: A red film-coated, oval, biconvex, bevelled edge tablet debossed with “ME” on one side of the tablet and “20” on the other side.
Maltese: Pillola miksija b'rita ta' kulur aħmar, b'tarf ġej għal xejn xejn, bikonvessa, imnaqqxa b'“ME” fuq naħa waħda tal-pillola u “20” fuq in-naħa l-oħra.
English: From Week 4 on: The patient should take two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet per day.
Maltese: Din tiżdied għal pillola waħda ta' 10 mg darba kuljum (10 mg) fit-tieni ġimgħa u għal pillola u nofs ta' 10 mg darba kuljum fit-tielet ġimgħa.
English: Further information on PecFent can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: PecFent (fentanyl)
Maltese: PecFent (fentanil)
English: This overview was last updated in 06-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi: 06-2018.
English: PecFent is a ‘hybrid medicine'.
Maltese: PecFent huwa ‘mediċina ibrida'.
English: The average reduction in pain during the first 30 minutes after use was 6.6 points in patients receiving PecFent compared with 4.5 in those receiving placebo.
Maltese: It-tnaqqis medju fl-uġigħ matul l-ewwel 30 minuta wara l-użu kien ta' 6.6 punti f'pazjenti li kienu qed jirċievu PecFent meta mqabbel ma' 4.5 f'dawk li kienu qed jirċievu lplaċebo.
English: PecFent received a marketing authorisation valid throughout the EU on 31 August 2010.
Maltese: PecFent irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fil31 ta' Awwissu 2010.
English: PecFent contains the active substance fentanyl.
Maltese: PecFent fih is-sustanza attiva fentanil.
English: Other information about PecFent:
Maltese: Informazzjoni oħra dwar PecFent:
English: PecFent is available as a nasal spray (100 and 400 micrograms per spray) and can only be obtained by ‘special' prescription.
Maltese: PecFent huwa disponibbli bħala sprej tal-imnieħer (100 u 400 mikrogramma għal kull sprej) u jista' jinkiseb biss b'riċetta ‘speċjali'.
English: As for all medicines, data on the use of PecFent are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' PecFent hija ssorveljata kontinwament.
English: The most serious of these side effects are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure).
Maltese: L- effetti l-aktar serji minn dawn l-effetti sekondarji huma dipressjoni respiratorja (inibizzjoni tan-nifs), dipressjoni ċirkolatorja (taħbit tal-qalb bil-mod), ipotensjoni (pressjoni tad-demm baxxa) u xokk (tnaqqis qawwi fil-pressjoni tad-demm).
English: What are the risks associated with PecFent?
Maltese: X'inhuma r-riskji assoċjati ma' PecFent?
English: The active substance in PecFent, fentanyl, is an opioid.
Maltese: Is-sustanza attiva f'PecFent, il-fentanil, hija opjojde.
English: In one main study, PecFent was shown to be more effective than placebo (a dummy treatment) at treating breakthrough cancer pain in 83 adults who were being treated with opioids.
Maltese: Fi studju ewlieni wieħed, PecFent intwera li huwa aktar effettiv minn plaċebo (kura finta) għal kura ta' dan l-episodju sever ta' wġigħ tal-kanċer fi 83 adult li kienu qed jiġu kkurati b'opjojdi.
English: This means that it is similar to ‘reference medicines' containing the same active substance, but given in a different way.
Maltese: Dan ifisser li huwa simili għal ‘mediċini ta' referenza' li fihom l-istess sustanza attiva, imma huma mogħtija b'mod differenti.
English: The first trial dose should always be 100 micrograms (one spray into one nostril).
Maltese: L-ewwel doża ta' prova għandha dejjem tkun ta' 100 mikrogramma (sprejjatura darba ġo toqba waħda tal-imnieħer).
English: While the reference medicines Effentora (buccal tablets) and Actiq (lozenges) are taken by mouth, PecFent is given as a spray into the nose.
Maltese: Filwaqt li l-mediċini ta' referenza Effentora (pilloli li jittieħdu mill-ħalq) u Actiq (pastilji) jittieħdu mill-ħalq, PecFent jingħata bħala sprej flimnieħer.
English: PecFent is a medicine used to treat breakthrough pain in adult patients with cancer.
Maltese: PecFent huwa mediċina li intuża biex tikkura episodju sever ta' wġigħ f'adulti bil-marda tal-kanċer.
English: Patients should be closely monitored for these side effects.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal dawn l-effetti sekondarji.
English: PecFent is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Maltese: PecFent jintuża f'pazjenti li diġà qegħdin jużaw opjojdi (grupp ta' mediċini li jtaffu l-uġigħ li jinkludu l-morfina u fentanil) biex jikkontrollaw l-uġigħ tal-kanċer fit-tul.
English: Because PecFent is a hybrid medicine, the applicant presented data on the reference medicines in addition to results from its own studies.
Maltese: Minħabba li Pecfent huwa mediċina ibrida, l-applikant ippreżenta data dwar il-mediċini ta' referenza flimkien ma' riżultati mill-istudji tiegħu stess.
English: What benefits of PecFent have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' PecFent li ħarġu mill-istudji?
English: Typical opioid side effects are to be expected with PecFent; often these will stop or become less intense with continued use of the medicine.
Maltese: Effetti sekondarji tipiċi ta' opjojd huma mistennija b'PecFent; spiss dawn se jieqfu jew isiru inqas intensi bl-użu kontinwu tal-mediċina.
English: For the full list of side effects reported with PecFent, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b' PecFent, ara l-fuljett ta' tagħrif.
English: An additional study measured the ‘acceptability' of PecFent by the patients, rating how satisfied they were with PecFent, and how easy and convenient they found it to use.
Maltese: Studju addizzjonali kejjel l-'aċċettabbiltà' ta' PecFent mill-pazjenti, billi kklassifika kemm kienu sodisfatti b'PecFent, u kemm sabuh faċli u konvenjenti biex jużawh.
English: The company that markets PecFent will provide educational materials in each EU Member State to make sure that patients, doctors and pharmacists are aware of how PecFent should be used, the risk of accidental exposure to fentanyl and how to dispose of the medicine.
Maltese: Il-kumpanija li tqiegħed PecFent fis-suq se tipprovdi materjal edukattiv f'kull Stat Membru tal-UE biex tiżgura li l-pazjenti, it-tobba u l-ispiżjara jkunu jafu kif PecFent għandu jintuża, ir-riskju ta' esponiment aċċidentali għal fentanil u dwar kif wieħed għandu jarmi l-mediċina.
English: In this study, patients reported that they were ‘satisfied' or ‘very satisfied' with PecFent treatment for around 90% of breakthrough pain episodes.
Maltese: F'dan l-istudju, il-pazjenti rrapportaw li kienu ‘sodisfatti' jew ‘sodisfatti ħafna' bil-kura b'PecFent għal madwar 90 % ta' dawn lepisodji severi ta' wġigħ..
English: What measures are being taken to ensure the safe and effective use of PecFent?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' PecFent?
English: Side effects reported with PecFent are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'PecFent huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The main measure of effectiveness was the change in the severity of pain measured by the patients ranking their pain on a scale from 0 to 10.
Maltese: Il-kejl ewlieni tal-effikaċja kienet il-bidla fis-severità tal-uġigħ imkejla mill-pazjenti li kklassifikaw l-uġigħ tagħhom fuq skala minn 0 sa 10.
English: Withdrawal of the marketing authorisation application for Begedina (begelomab) EMA/579473/2016
Maltese: (begelomab) EMA/579456/2016
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 July 2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 ta' Lulju 2016 EMA/579456/2016 EMEA/H/C/004144
English: Begedina is a medicine that contains the active substance begelomab.
Maltese: Begedina huwa mediċina li fiha s-sustanza attiva begelomab.
English: Begedina was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 November 2010 for treatment of graft-versus-host disease.
Maltese: Begedina kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis26 ta' Novembru 2010, għall-kura tal-marda graft-versus-host.
English: Withdrawal of the marketing authorisation application for Begedina (begelomab)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat tqegħid fis-suq għal Begedina (begelomab)
English: By attaching to CD26, this medicine is expected to reduce the rate at which the T cells multiply.
Maltese: Meta teħel mas-CD26, din ilmediċina hija mistennija li tnaqqas ir-rata li biha ċ-ċelloli T jimmultiplikaw.
English: Begedina was expected to be used for the treatment of acute graft-versus-host disease (a condition in which transplanted cells attack the patient's body) in adults who have had haematopoietic progenitor cell transplantation (transplant of cells that can develop into different types of blood cells) from a donor.
Maltese: Begedina kien mistenni li jintuża għall-kura tal-marda akuta graft-versus-host (kundizzjoni li fiha ċċelloli trapjantati jattakkaw il-ġisem tal-pazjent) fl-adulti li kellhom trapjant taċ-ċelloli emopojetiċi proġenituri (trapjant ta' ċelloli li jistgħu jiżviluppaw f'tipi differenti ta' ċelloli tad-demm) mingħand donatur.
English: What is Begedina?
Maltese: X'inhu Begedina?
English: It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.
Maltese: Kellha tkun disponibbli bħala konċentrat biex isir soluzzjoni għall-infużjoni (dripp) ġo vina.
English: The CHMP considered that the data provided were insufficient to demonstrate a beneficial effect of Begedina.
Maltese: Is-CHMP ikkunsidra li d-data pprovduta ma kinitx suffiċjenti sabiex turi effett benefiku ta' Begedina.
English: What was Begedina expected to be used for?
Maltese: Kif kien mistenni li jaħdem Begedina?
English: The active substance in Begedina, begelomab, is a monoclonal antibody (a type of protein) that has been designed to attach itself to a receptor called CD26, which is present on T cells.
Maltese: Begelomab, is-sustanza attiva f'Begedina, huwa antikorp monoklonali (tip ta' proteina) li ġie ddisinjat biex jeħel ma' reċettur imsejjaħ CD26, li huwa preżenti fuq wiċċ iċ-ċelloli T. Dawn huma tip ta' ċelloli bojod tad-demm li għandhom rwol fil-marda tal-graft-versus-host.
English: How was Begedina expected to work?
Maltese: Għal xiex kien mistenni li jintuża Begedina?
English: The company presented the results of two studies with Begedina involving a total of 29 adults with acute graft-versus-host disease that did not respond to steroid treatment.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' żewġ studji b'Begedina li kienu jinvolvu total ta' 29 adult bilmarda akuta tal-graft-versus-host li fuqhom, il-kura bl-isterojdi ma ħadmitx.
English: Questions and answers
Maltese: Dan huwa mistenni li
English: activity of T cells from the transplant that attack the patient's organs, thereby helping to control graftversus-host disease.
Maltese: jnaqqas in-numru u l-attività taċ-ċelloli T mit-trapjant li jattakka lill-organi tal-pazjent, u b'hekk jgħin fil-kontroll tal-marda tal-graft-versus-host.
English: There were also deficiencies identified in the manufacturing process of the medicine.
Maltese: Kien hemm ukoll xi nuqqasijiet identifikati fil-proċess talmanifattura tal-mediċina.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Begedina.
Maltese: Il-kumpanija infurmat lis-CHMP li fil-preżent ma hemm ebda konsegwenza għal pazjenti li fil-preżent huma inklużi fil-provi kliniċi b'Begedina.
English: 17 December 2012
Maltese: 17 ta' Diċembru 2012
English: 1 Article 35 of Directive 2001/82/EC, as amended
Maltese: 1 L-Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylic acid derivatives.
Maltese: Enrofloxacin huwa sustanza kemoterapewtika sintetika mill-klassi tad-derivattivi tal-fluoroquinolone carboxylic acid.
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Maltese: Għandha attività antibatterjali kontra spettru wiesa' ta' batterji Gram-negattivi u Gram-pożittivi.
English: The Committee appointed Dr M. Holzhauser-Alberti as rapporteur and Dr C. Muñoz Madero as co-rapporteur.
Maltese: Muñoz Madero bħala ko-rapporteur.
English: Supplementary information was provided in writing by an applicant and marketing authorisation holders on 16 January 2012.
Maltese: Informazzjoni supplimentari ġiet ipprovduta bil-miktub minn applikant u mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fis-16 ta' Jannar 2012.
English: Enrofloxacin is for veterinary use only.
Maltese: Enrofloxacin huwa għal użu veterinarju biss.
English: On 30 September 2011, France initiated a referral procedure under Article 35 of Directive 2001/82/EC, as amended, for the veterinary medicinal product HIPRALONA ENRO-S and its generics indicated for use in rabbits, due to concerns that the use of the products in rabbit production would increase Escherichia coli and Staphylococcus aureus resistance to enrofloxacin.
Maltese: Fit-30 ta' Settembru 2011, Franza tat bidu għal proċedura ta' riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE, kif emendata, għall-prodott mediċinali veterinarju HIPRALONA ENRO-S u lġeneriċi tiegħu indikat għall-użu fil-fniek, minħabba tħassib li l-użu tal-prodotti fil-produzzjoni tal-fniek iżid ir-reżistenza ta' Escherichia coli u Staphylococcus aureus għal enrofloxacin.
English: HIPRALONA ENRO-S and its generics are veterinary medicinal products which contain enrofloxacin as active substance, and are indicated in rabbits for the treatment of respiratory infections caused by Pasteurella multocida.
Maltese: HIPRALONA ENRO-S u l-ġeneriċi tiegħu huma prodotti mediċinali veterinarji li fihom l-enrofloxacin bħala s-sustanza attiva, u huma indikati fil-fniek għall-kura ta' infezzjonijiet respiratorji kkawżati minn Pasteurella multocida.
English: The referral procedure started on 12 October 2011.
Maltese: Il-proċedura ta' riferiment bdiet fit-12 ta' Ottubru 2011.
English: On 13 September 2012, the CVMP adopted by majority a revised opinion confirming the recommendation, included in its opinion of 11 April 2012, that the marketing authorisations for the veterinary medicinal product HIPRALONA ENRO-S and its generics should be maintained in accordance with the previously approved product information.
Maltese: Fit-13 ta' Settembru 2012, is-CVMP adotta b'maġġoranza opinjoni riveduta li tikkonferma rrakkomandazzjoni, inkluża fl-opinjoni tiegħu tal-11 ta' April 2012, li l-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodott mediċinali veterinarju HIPRALONA ENRO-S u l-ġeneriċi tiegħu għandhom jinżammu skont l-informazzjoni dwar il-prodott approvata preċedentament.
English: The dosage is 10 mg enrofloxacin per kg bodyweight during 5 days.
Maltese: Id-dożaġġ huwa 10 mg enroflaxacin għal kull kg piż tal-ġisem matul ħamest ijiem.
English: International non-proprietary name (inn): enrofloxacin Background information
Maltese: Opinjoni wara riferiment skont l-Artikolu 35
English: On 14 May 2012, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to antimicrobial resistance and the prudent use of antimicrobials in veterinary medicine.
Maltese: Fl-14 ta' Mejju 2012, il-Kummissjoni Ewropea talbet lis-CVMP sabiex jirrevedi l-opinjoni tiegħu, jiġifieri li jiċċara xi aspetti relatati mar-reżistenza antimikrobijali u l-użu prudenti ta' antimikrobijali fil-mediċina veterinarja.
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Enviage.
Maltese: Indutturi ta' P-gp (St. John's wort, rifampicin) għalhekk jistgħu jnaqqsu l-biodisponibilità ta' Enviage.
English: Co-administration of aliskiren with either valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Enviage.
Maltese: Meta aliskiren jingħata ma' valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) jew cimetidine (↑19%) is-Cmax jew AUC ta' Enviage inbidlu b'bejn 20% u 30%.
English: INFORMATION IN BRAILLE Enviage 300 mg
Maltese: Enviage 300 mg
English: Enviage has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Maltese: Enviage kien studjat f'1,864 pazjent ta' etajiet minn 65 sena 'l fuq, u f'426 pazjent ta' etajiet minn 75 sena 'l fuq.
English: The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Enviage and placebo, respectively.
Maltese: Ilproporzjon tal-pazjenti li kellhom tnaqqis fil-UACR b'mill-anqas 50% mill-linja bażi sat-tragward finali kien ta' 24.7% u 12.5% għal Enviage u l-plaċebo, rispettivament.
English: The incidence of cough was similar in placebo (0.6%) and Enviage treated (0.9%) patients.
Maltese: L-inċidenza tas-sogħla kienet simili f'pazjenti ikkurati bi plaċebo (0.6%) u b'Enviage (0.9%).
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Enviage.
Maltese: Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f'parametri standard tal-laboratorju kienu assoċjati b'mod mhux komuni ma' l-għoti ta' Enviage.
English: INFORMATION IN BRAILLE Enviage 150 mg
Maltese: Enviage 150 mg
English: In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Enviage 300 mg achieved a 20% reduction versus placebo in urinary albumin:creatinine ratio (UACR), i.e. from 58 mg/mmol to 46 mg/mmol.
Maltese: Fi studju ta' 6 xhur ta' 599 pazjent bi pressjoni għolja, dijabete mellitus tat-tip 2, u nefropatija, li kollha kemm huma kienu qed jingħataw losartan 100 mg u terapija ta' sfond adattata għal kontra lpressjoni għolja, iż-żieda ta' Enviage 300 mg kisbet tnaqqis ta' 20% kontra plaċebo, i.e. minn 58 mg/mmol għal 46 mg/mmol, fil-proporzjon ta' l-albumina mal-krejatina fl-awrina (UACR).
English: Enviage is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Maltese: Enviage jiġi f'pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.