FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with unstable angina or myocardial infarction without ST segment elevation waiting for further treatment, the main study involved almost 14,000 adults and compared Angiox taken alone or with a GPI, with the combination of heparin and a GPI.
Maltese: Fil-każ tat-trattament ta' anġina mhux stabbli jew infart mijokardijaku mingħajr elevazzjoni tat-taqsima ST f'pazjenti li qegħdin jistennew iktar kura, l-istudju prinċipali involva kważi 14,000 adult u qabbel Angiox meħud waħdu jew ma' GPI, ma' taħlita ta' eparina u GPI.
English: The CHMP concluded that Angiox is an acceptable substitute for heparin during PCI and in the treatment of unstable angina and myocardial infarction.
Maltese: Is-CHMP kkonkluda li Angiox huwa sostitut aċċettabbli għall-eparina matul il-PCI u fil-kura ta' anġina instabbli u infart mijokardiku.
English: The main measure of effectiveness was the reduction in the number of patients who had an ‘ischaemic event' (a problem caused by reduced blood flow) including death, a heart attack, urgent revascularisation (restoration of blood flow to the heart) or stroke after 30 days.
Maltese: Il-kejl ewlieni tal-effikaċja kien it-tnaqqis fin-numru ta' pazjenti li kellhom ‘puplesija iskemika' (problema kkawżata minn tnaqqis fil-fluss tad-demm) inkluż il-mewt, attakk talqalb, rivaskulurizzazzjoni urġenti (fluss ta' demm mill-ġdid lejn il-qalb) jew puplesija wara 30 jum.
English: Angiox is a medicine that contains the active substance bivalirudin.
Maltese: Angiox huwa mediċina li fih is-sustanza attiva bivalirudin.
English: When used to treat unstable angina or myocardial infarction without ST segment elevation, Angiox, given with or without a GPI, was as effective as the combination of heparin and a GPI in preventing deaths, heart attacks and revascularisations.
Maltese: Meta użat biex jittratta anġina mhux stabbli jew infart mijokardijaku mingħajr elevazzjoni tat-taqsima ST, Angiox mogħti flimkien jew mingħajr GPI, kien effikaċi bħal f'kombinazzjoni ta' eparina u GPI fil-prevenzjoni ta' mwiet, attakki tal-qalb u rivaskulurizzazzjonijiet.
English: Angiox is also used to treat adults with unstable angina (a type of chest pain that varies in severity) or myocardial infarction without ST segment elevation, who are waiting for further treatment such as PCI, a heart bypass or using other medicines.
Maltese: Angiox jintuża wkoll fil-kura ta' adulti b'anġina instabbli (tip ta' uġigħ fis-sider li jvarja fil-gravità) jew infart mijokardijaku (attakk tal-qalb) mingħajr elevazzjoni segmentali
English: Angiox is an anticoagulant, which means that it prevents the blood from clotting.
Maltese: Angiox huwa antikoagulant, li jfisser li jipprevjeni d-demm milli jagħqad.
English: Almost 4,000 of the patients were having PCI to treat myocardial infarction with ST segment elevation.
Maltese: Kważi 4,000 mill-pazjenti li kienu fuq PCI bit-trattament ta' infart mijokardijaku b'elevazzjoni tat-taqsima ST.
English: Angiox is used together with aspirin and clopidogrel (other medicines that help to prevent blood clots).
Maltese: Angiox jintuża flimkien mal-aspirina u l-klopidogrel (mediċini oħra li jgħinu fil-prevenzjoni ta' emboli tad-demm).
English: What is the risk associated with Angiox?
Maltese: X'inhu r-riskju assoċjat ma' Angiox?
English: In both studies of patients undergoing PCI, Angiox (alone or with a GPI where appropriate) was as effective as heparin in combination with a GPI at preventing new ischaemic events.
Maltese: Fiż-żewġ studji l-pazjenti li għaddew minn PCI, Angliox (waħdu jew ma' GPI fejn xieraq) kien effettiv daqs l-eparina flimkien ma' GPI fil-prevenzjoni ta' puplesiji iskemiċi ġodda.
English: It is available as a powder that is made up into a solution for injection or infusion (drip) into a vein.
Maltese: Angiox huwa disponibbli bħala trab li jinħall biex jifforma soluzzjoni għall-injezzjoni jew l-infużjoni (dripp f'vina).
English: The full EPAR for Prevomax can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Prevomax is a ‘generic medicine'.
Maltese: Prevomax huwa ‘mediċina ġenerika'.
English: Prevomax contains the active substance maropitant.
Maltese: Prevomax fih is-sustanza attiva maropitant.
English: This is a summary of the European public assessment report (EPAR) for Prevomax.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Prevomax.
English: The active substance in Prevomax, maropitant, stops a chemical in the body (substance P) from attaching to certain targets called neurokinin-1 (NK1) receptors, which are found on the surface of cells in the part of the brain that controls nausea and vomiting.
Maltese: Is-sustanza attiva f'Prevomax, maropitant, twaqqaf sustanza kimika fil-ġisem (sustanza P) milli teħel ma' ċerti miri msejħa riċetturi ta' neurokinin-1 (NK1), li jinsabu fuq il-wiċċ taċ-ċelloli fil-parti tal-moħħ li tikkontrolla n-nawżja u r-rimettar.
English: Why is Prevomax approved?
Maltese: Għaliex ġie approvat Prevomax?
English: Other information about Prevomax?
Maltese: Informazzjoni oħra dwar Prevomax?
English: Prevomax is injected once daily under the skin or into a vein (1 mg/per kg bodyweight) for up to five days.
Maltese: Prevomax jiġi injettat darba kuljum taħt il-ġilda jew ġo vina (1 ml/għal kull kg tal-piż tal-ġisem) għal mhux aktar minn ħamest ijiem.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Cerenia, and do not need to be repeated for Prevomax.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi approvati bil-mediċina ta' referenza, Cerenia, u ma għandhomx għalfejn jiġu ripetuti għal Prevomax.
English: Because Prevomax 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 Prevomax 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: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Prevomax has been shown to have comparable quality and to be bioequivalent to Cerenia, solution for injection.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, Prevomax wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Cerenia, soluzzjoni għall-injezzjoni.
English: There was no need for ‘bioequivalence' studies to investigate whether Prevomax is absorbed similarly to the reference medicine, Cerenia solution for injection, to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn għal studji ta' ‘bijoekwivalenza' biex jiġi investigat jekk Prevomax jiġix assorbit b'mod simili għall-mediċina ta' referenza, Cerenia soluzzjoni għall-injezzjoni, biex jipproduċi l-istess livell tas-sustanza attiva fid-demm.
English: How is Prevomax used?
Maltese: Kif jaħdem Prevomax?
English: This means that Prevomax contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Cerenia.
Maltese: Dan ifisser li Prevomax fih l-istess sustanza attiva u jaħdem blistess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Cerenia.
English: How has Prevomax been studied?
Maltese: Kif ġie studjat Prevomax?
English: The precautions are the same as for the reference medicine since Prevomax is a generic medicine.
Maltese: Il-prekawzjonijiet huma bħal dawk tal-mediċina ta' referenza minħabba li Prevomax huwa mediċina ġenerika.
English: Therefore, the CVMP's view was that, as for Cerenia, the benefits outweigh the identified risks.
Maltese: Għaldaqstant, il-fehma tas-CVMP kienet li, bħal fil-każ ta' Cerenia, ilbenefiċċji huma akbar mir-riskji identifikati.
English: In dogs Prevomax can also be used both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine.
Maltese: Fil-klieb Prevomax jista' jintuża kemm għall-prevenzjoni ta' nawżja u ta' rimettar kemm qabel kif ukoll wara intervent kirurġiku u biex jitjieb l-irkupru mill-anestesija ġenerali wara l-użu ta' morfina.
English: When given by injection under the skin, the active substance in Prevomax is expected to be absorbed in the same way as the reference medicine.
Maltese: Meta tingħata permezz ta' injezzjoni taħt il-ġilda, is-sustanza attiva f'Prevomax hija mistennija li tiġi assorbita bl-istess mod bħall-mediċina ta' referenza.
English: What are the benefits and risks of Prevomax?
Maltese: X᾽ inhuma l-benefiċċji u r-riskji ta᾽ Prevomax?
English: Intravenous use, Subcutaneous use
Maltese: Użu ġol-vina, Użu għal taħt ilġilda
English: 14 June 2012
Maltese: 14 ta' Ġunju 2012
English: Article 35 of Directive 2001/82/EC, as amended
Maltese: L-Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata
English: International non-proprietary name (inn): tilmicosin
Maltese: Denominazzjoni Komuni Internazzjonali (inn): tilmikosina
English: Therefore, the
Maltese: IV.
English: Tilmicosin is a semi-synthetic antibiotic of the macrolide group.
Maltese: It-tilmikosina hija antibijotiku semisintetiku tal-grupp makrolidi.
English: The Committee appointed Dr Cristina Muñoz Madero as rapporteur and Dr Petras Mačiulskis as co-rapporteur.
Maltese: Il-Kumitat ħatar lil Dr Cristina Muñoz Madero bħala relatur u lil Dr Petras Mačiulskis bħala korelatur.
English: Written explanations were provided by the marketing authorisation holders on 31 August 2011 and 20 January 2012.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovdew lispjegazzjonijiet bil-miktub fil-31 ta' Awwissu 2011 u fl-20 ta' Jannar 2012.
English: The referral started on 5 May 2011.
Maltese: Ir-referenza bdiet fil-5 ta' Mejju 2011.
English: On 8 April 2011, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g tilmicosin per kg premix and administered to rabbits.
Maltese: Fit-8 ta' April 2011, il-Kummissjoni Ewropea ppreżentat notifika ta' referenza lill-Aġenzija skont lArtikolu 35 tad-Direttiva 2001/82/KE, dwar il-kodiċi tal-Komunità rigward il-prodotti mediċinali veterinarji li fihom 40 g, 100 g jew 200 g tilmikosina għal kull kg taħlit lest u li jingħata lill-fniek.
English: The pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g of tilmicosin per kg pre-mix, are veterinary medicinal products which are indicated in pigs and rabbits for the prevention and treatment of respiratory diseases caused by microorganisms susceptible to tilmicosin.
Maltese: It-taħlit lest għal għalf medikat li fih 40 g, 100 g jew 200 g ta' tilmikosina għal kull kg taħlit lest, huwa prodott mediċinali veterinarju li huwa indikat fil-ħnieżer u l-fniek għall-prevenzjoni u l-kura ta' mard respiratorju kkawżat minn mikrorganiżmi suxxettibli għat-tilmikosina.
English: Opinion following an Article 351 referral for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits
Maltese: Opinjoni skont referenza tal-Artikolu 350F għat-taħlit kollu lest għal għalf medikat li fih 40 g, 100 g jew 200 g tilmikosina għal kull kg taħlit lest u li jingħata lill-fniek
English: Committee for medicinal products for veterinary use (CVMP)
Maltese: Kumitat għall-prodotti mediċinali għall-użu veterinarju
English: Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to recommended changes of the product information and conditions affecting the marketing authorisations for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits.
Maltese: Fuq il-bażi tal-evalwazzjoni tad-dejta disponibbli attwalment, is-CVMP ikkunsidra li l-profil globali bejn il-benefiċċju u r-riskju għal dawn il-prodotti jibqa' pożittiv soġġett għal tibdil rakkomandat talinformazzjoni tal-prodott u l-kundizzjonijiet li jaffettwaw l-awtorizzazzjonijiet għat-tqegħid fis-suq għat-taħlit kollu lest għal għalf medikat li fih 40 g, 100 g jew 200 g tilmikosina għal kull kg taħlit lest u li jingħata lill-fniek.
English: Opinion following an Article 350F referral for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits EMA/294698/2012
Maltese: L-opinjoni finali ġiet konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fl-14 ta' Ġunju 2012.
English: EMA/778900/2014 EMEA/H/C/003787
Maltese: EMEA/H/C/003787
English: It is a ‘generic medicine'.
Maltese: Huwa ‘mediċina ġenerika'.
English: The active substance of Tadalafil Mylan, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors'.
Maltese: Is-sustanza attiva ta' Tadalafil Mylan, tadalafil, tappartjeni għal grupp ta' mediċini msejħin 'inibituri talfosfodjesterażi ta' tip 5 (PDE5)'.
English: The full EPAR and risk management plan summary for Tadalafil Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Tadalafil Mylan jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tadalafil Mylan contains the active substance tadalafil.
Maltese: Tadalafil Mylan fih is-sustanza attiva tadalafil.
English: For treating erectile dysfunction, the recommended dose of Tadalafil Mylan is 10 mg taken ‘on demand' at least 30 minutes before sexual activity.
Maltese: Għall-kura ta' disfunzjoni erettili, id-doża rrakkomandata ta' Tadalafil Mylan hija ta' 10 mg meħuda ‘meta hemm bżonn' tal-inqas 30 minuta qabel l-attività sesswali.
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Maltese: Taħdem billi tibblokka l-enzima fosfodjesterażi, li normalment tkisser sustanza magħrufa bħala cyclic guanosine monophosphate (cGMP).
English: The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg Tadalafil Mylan is not recommended.
Maltese: Il-frekwenza ta' doża massima rakkomandata hija darba kuljum, iżda użu kontinwu ta' kuljum ta‘ 10 jew 20 mg ta' Tadalafil Mylan mhuwiex rakkomandat.
English: This is a summary of the European public assessment report (EPAR) for Tadalafil Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tadalafil Mylan.
English: Tadalafil Mylan can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous), which involve problems with the flow of urine.
Maltese: Tadalafil Mylan jista' jintuża wkoll f'irġiel għall-kura ta' sinjali u sintomi ta' iperplasija beninna talprostata (glandola tal-prostata mkabbra li mhijiex kanċeruża), li tinvolvi problemi bil-fluss tal-awrina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Mylan on 21 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tadalafil Mylan fil-21 ta' Novembru 2014.
English: Once-a-day dosing is not recommended in patients with severely impaired kidney function, and should only be prescribed to patients with impaired liver function after a careful evaluation of the benefits and risks of taking the medicine.
Maltese: Dożaġġ ta' darba kuljum mhuwiex rakkomandat f'pazjenti b'funzjoni tal-kliewi indebolita severament, u m'għandux jiġi preskritt lil pazjenti b'funzjoni tal-fwied indebolita wara evalwazzjoni bir-reqqa tal-benefiċċji u r-riskji tat-teħid tal-mediċina.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Maltese: Waqt stimulazzjoni sesswali normali, cGMP jiġi prodott fil-pene, fejn jikkawża lill-muskolu fit-tessut artab tal-pene (il-corpora cavernosa) sabiex jirrilassa, u dan iħalli l-fluss tad-demm fil-corpora, u joħloq erezzjoni.
English: This means that Tadalafil Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cialis.
Maltese: Dan ifisser li Tadalafil Mylan huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Cialis.
English: This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.
Maltese: Dan jista' jnaqqas il-problemi bil-fluss tal-awrina li huma sintomi ta' iperplasija beninna tal-prostata.
English: Because Tadalafil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cialis.
Maltese: Minħabba li Tadalafil Mylan huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet biex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Cialis.
English: Other information about Tadalafil Mylan
Maltese: Informazzjoni oħra dwar Tadalafil Mylan
English: Why is Tadalafil Mylan approved?
Maltese: Għaliex ġie approvat Tadalafil Mylan?
English: Because Tadalafil Mylan 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 Tadalafil Mylan 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: For treating men with benign prostatic hyperplasia, or men with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.
Maltese: Għall-kura ta' rġiel b'iperplasija beninna tal-prostata, jew ta' rġiel b'kemm iperplasija beninna talprostata kif ukoll b'disfunzjoni erettili, id-doża rakkomandata hija ta' 5 mg darba kuljum.
English: A risk management plan has been developed to ensure that Tadalafil Mylan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Tadalafil Mylan jintuża bl-aktar mod sigur possibbli.
English: The Committee recommended that Tadalafil Mylan be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Tadalafil Mylan ikun approvat għall-użu fl-UE.
English: The dose may be increased to 20 mg for men who do not respond to the 10 mg dose.
Maltese: Id-doża tista' tiġi miżjuda għal 20 mg għal irġiel li ma kellhomx rispons għad-doża ta' 10 mg.
English: Tadalafil Mylan is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Maltese: Tadalafil Mylan jintuża għall-kura ta' rġiel b'disfunzjoni erettili (xi drabi msejħa impotenza) fejn ma jkunux jistgħu jiksbu, jew iżommu, pene iebes (erezzjoni) suffiċjenti għal attività sesswali sodisfaċenti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tadalafil Mylan has been shown to have comparable quality and to be bioequivalent to Cialis.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Tadalafil Mylan wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Cialis.
English: By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Tadalafil Mylan also improves the blood flow to, and relaxes the muscles of, the prostate and bladder.
Maltese: Billi jimblokka l-enzma fosfodjesterażi u jipprevjeni t-tkissir ta' cGMP, Tadalafil Mylan itejjeb ukoll il-fluss tad-demm għal, u jirrilassa l-muskolu tal-prostata u tal-borża tal-awrina.
English: What are the benefits and risks of Tadalafil Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Tadalafil Mylan?
English: By blocking the breakdown of cGMP, Tadalafil Mylan restores erectile function.
Maltese: Billi jimblokka ttkissir ta' cGMP, Tadalafil Mylan iġib lura l-funzjoni erettili.
English: Travoprost is an ester prodrug.
Maltese: Travoprost huwa ester prodrug.
English: Mean Difference a
Maltese: Differenza Medja a
English: B-2870 Puurs Belgium
Maltese: B-2870 Puurs Il-Belġju
English: (picture 3).
Maltese: (stampa 2).
English: SE = Standard Error; CI = Confidence Interval;
Maltese: SE = Żball Standard; CI = Intervall ta' Kunfidenza;
English: Iritis/uveitis
Maltese: Irite/uveite
English: What IZBA contains - The active substance is travoprost.
Maltese: X'fih IZBA - Is-sustanza attiva hi travoprost.
English: Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq Novartis Europharm Limited Vista Building
English: 16 INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jistgħu jaffettwaw sa persuna waħda minn kull 1,000
English: Mean (SE)
Maltese: Medja (SE)
English: Aqueous humour concentrations declined with a half-life of approximately 1.5 hours.
Maltese: Konċentrazzjonijiet fl-aqueous humour naqsu b'half life ta' bejn wieħed u ieħor 1.5 sigħat.
English: In a similar 3-month study in adult patients, these events occurred at an incidence of 11.4% and 0%, respectively.
Maltese: Fi studju simili ta' 3 xhur f'pazjenti adulti, dawn lavvenimenti seħħew b'inċidenza ta' 11.4% u 0%, rispettivament.
English: Rare musculoskeletal pain, arthralgia
Maltese: Rari uġigħ muskolu-skeletriku, artralġja
English: Travoprost is considered a persistent, bioaccumulative and toxic (PBT) substance.
Maltese: Travoprost huwa kkunsidrat bħala sustanza persistenti, ta' bijoakkumulazzjoni u tossika (PBTpersistent, bioaccumulative and toxic).
English: Mean IOP reductions in the travoprost and timolol groups were similar (see Table 4).
Maltese: Il-medja fit-tnaqqis tal-IOP fil-gruppi ta' travoprost u timolol kienet simili (ara Tabella 4).
English: System Organ class
Maltese: Klassi tas-Sistemi u talOrgani
English: Mean difference is travoprost - timolol.
Maltese: Id-differenza medja hija travoprost - timolol.
English: It should be noted that travoprost is considered a PBT substance (see section 5.3).
Maltese: Għandu jiġi nnutat li travoprost huwa meqjus bħala sustanza PBT (ara sezzjoni 5.3).
English: Rare asthenia
Maltese: Rari astenja
English: Polyquaternium-1, polyoxyethylene hydrogenated castor oil 40 (HCO-40), boric acid, mannitol, sodium chloride, propylene glycol, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.
Maltese: Polyquaternium-1, polyoxyethylene hydrogenated castor oil 40 (HCO-40), boric acid, mannitol, sodium chloride, propylene glycol, sodium hydroxide u/jew hydrochloric acid (għall-aġġustament talpH) u ilma ppurifikat.
English: In the age groups 3 to <12 years (n=36) and 12 to <18 years (n=26), mean IOP reduction at Week 12 in the travoprost group was similar to that in the timolol group.
Maltese: Fil-gruppi ta' età 3 snin sa <12-il sena (n=36) u 12-il sena sa <18-il sena (n=26), it-tnaqqis medju flIOP f'Ġimgħa 12 fil-grupp ta' travoprost kien simili għal dik fil-grupp ta' timolol.
English: The most frequent adverse reactions reported in the paediatric population were ocular hyperaemia (16.9%) and growth of eyelashes (6.5%).
Maltese: Irreazzjonijiet avversi l-aktar frekwenti rrappurtati fil-popolazzjoni pedjatrika kienu iperimja talgħajnejn (16.9%) u t-tkabbir ta' xagħar (6.5%).