FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Maltese: Fi provi kliniċi fuq pazjenti b'żieda fil-livell tal-kalċju fid-demm minħabba tumuri (TIH), il-profil ta' sigurtà fost it-tliet gruppi ttrattati (zoledronic acid 4 mg u zoledronic acid 8 mg u pamidronate) kien listess mil-lat ta' tipi u severità.
English: Do not use Zometa after the expiry date stated on the pack.
Maltese: - Tużax Zometa wara d-data ta' skadenza li tidher fuq il-pakkett.
English: Remove the following amount of Zometa solution for infusion (ml)
Maltese: Neħħi dan l-ammont ta' Zometa soluzzjoni għall-infużjoni (ml)
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Maltese: Żieda fil-livelli tal-kreatinina u l-urea fiddemm, u tnaqqis fil-livell tal-kalċju
English: Radiation therapy to bone zoledronic acid 4 mg
Maltese: Terapija tal-għadam bir-radjazzjoni zoledronic acid 4 mg
English: The response rate in these patients was about 52%.
Maltese: Ir-rata ta' rispons f'dawn ilpazjenti kienet ta' madwar 52%.
English: The active substance in Zometa is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Maltese: Is-sustanza attiva f'Zometa hija zoledronic acid li jagħmel parti minn grupp ta' sustanzi li jissejħu bisfosfonati.
English: Zometa 4 mg/100 ml solution for infusion should be given as a single intravenous infusion in no less than 15 minutes.
Maltese: Zometa 4 mg/100 ml soluzzjoni għall-infużjoni għandha tingħata bħala infużjoni waħda għal ġol-vini f'mhux inqas minn 15-il minuta.
English: The onset time is ≤ 3 days post-Zometa infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Maltese: Iż-żmien ta' meta tibda huwa ≤3 ijiem wara l-infużjoni ta' Zometa, u r-reazzjoni hija wkoll magħrufa bit-termini ta' sintomi “li jixbhu l-influwenza” jew “ta' wara d-doża”.
English: Acquired Fanconi syndrome
Maltese: Reazzjoni ta' fażi akuta
English: Withdraw the appropriate volume of the reconstituted solution (4 mg/5 ml), as follows: 4.4 ml for 3.5 mg dose
Maltese: Iġbed il-volum meħtieġ tas-soluzzjoni rrikostitwita (4 mg/5 ml), kif ġej: 4.4 ml għal doża ta' 3.5 mg
English: How to store Zometa
Maltese: Doża ta' Zometa rrakkomandata*
English: Instructions for preparing reduced doses of Zometa:
Maltese: Istruzzjonijiet biex tipprepara d-dożi meħtieġa ta' Zometa:
English: Pain in extremities, arthralgia, musculoskeletal pain
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-infużjoni Soluzzjoni ċara u bla kulur
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Maltese: L-effetti avversi li ġejjin, elenkati f'Tabella 1 inġabru f'daqqa mill-istudji kliniċi u minn rapporti ta' wara t-tqegħid fis-suq wara kura li fil-parti l-kbira kienet kronika b'zoledronic acid 4 mg: Tabella 1
English: Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Maltese: Parti minnhom reġgħu ħarġulhom is-sintomi meta reġgħu ngħataw Zometa jew bisfosfonat ieħor.
English: To avoid potential incompatibilities, Zometa concentrate is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Maltese: Biex wieħed jevita inkompatibbiltajiet, il-konċentrat ta' Zometa għandu jiġi ddilwit b'sodium chloride 0.9% w/v jew soluzzjoni ta' glucose 5% w/v.
English: Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
Maltese: Studji kliniċi ta' żieda fil-livell tal-kalċju fid-demm minħabba tumuri (TIH) urew li l-effett ta' zoledronic acid huwa kkaratterizzat minn tnaqqis ta' kalċju fis-serum u tnaqqis fl-eskrezzjoni urinarja ta' kalċju.
English: The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Maltese: Il-punt aħħari ewlieni tal-istudju kien il-perċentwali ta' bidla mil-linja bażi fid-densità minerali talgħadam (BMD) fil-parti lumbari tas-sinsla wara 12-il xahar ta' kura.
English: Hypocalcaemia-related ADRs
Maltese: ADRs marbutin ma' ipokalċimija
English: Hepatic insufficiency
Maltese: GĦAMLA KWALITATTIVA
English: EMA/336268/2014 EMEA/V/C/003683
Maltese: EMEA/V/C/003683
English: • canine parainfluenza virus, which causes kennel cough;
Maltese: • il-virus tal-parainfluwenza tal-klieb, li jikkawża l-"kennel cough";
English: Versican Plus Pi/L4 is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa).
Maltese: Versican Plus Pi/L4 huwa vaċċin veterinarju li fih il-virus tal-parainfluwenza tal-klieb ħaj attenwat (imdgħajjef) tat-tip 2 kif ukoll ir-razez inattivati (maqtulin) tal-batterji ta' Leptospira (Icterohaemorrhagiae, Canicola, Bratislava u Grippotyphosa).
English: The field study showed that after vaccination with Versican Plus Pi/L4 the percentage of dogs with protective levels of antibodies for parainfluenza virus ranged from 73 to 97% and for leptospira 59 to 96%.
Maltese: L-istudju fuq il-post wera li wara t-tilqima b'Versican Plus Pi/L4, il-perċentwal ta' klieb b'livelli protettivi ta' antikorpi għall-virus tal-parainfluwenza varja minn 73 għal 97% u għal leptospira minn 59 sa 96%.
English: The effectiveness of Versican Plus Pi/L4 was investigated in a field study involving 129 dogs.
Maltese: L-effikaċja ta' Versican Plus Pi/L4 ġie investigat fi studju fuq il-post li involva 129 kelb.
English: This will help protect them against kennel cough and leptospirosis.
Maltese: Dan jgħin jipproteġihom kontra l-"kennel cough" u lleptospirożi.
English: Canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine
Maltese: Vaċċin tal-virus tal-parainfluwenza tal-klieb (ħaj attenwat) u leptospirożi talklieb (inattivat)
English: hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation).
Maltese: epatite (infjammazzjoni tal-fwied) u suffejra jew nefrite (infjammazzjoni tal-kliewi).
English: Other information about Versican Plus Pi/L4:
Maltese: Informazzjoni oħra dwar Versican Plus Pi/L4:
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi/L4 is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Maltese: L-effett sekondarju l-aktar komuni (li deher f'aktar minn kelb 1 minn kull 100) b'Versican Plus Pi/L4 kien nefħa għal żmien qasir ta' massimu ta' 5 cm li tista' sseħħ fis-sit tal-injezzjoni wara t-tilqima.
English: The canine parainfluenza virus in Versican Plus Pi/L4 is alive but has been attenuated (weakened) so that it does not cause disease; it is combined with killed (inactivated) strains of Leptospira bacteria.
Maltese: Il-virus tal-parainfluwenza tal-klieb f'Versican Plus Pi/L4 huwa ħaj iżda ġie attenwat (imdgħajjef) sabiex ma jikkawżax il-marda; huwa kkombinat ma' razez maqtulin (inattivati) tal-batterji ta' Leptospira.
English: Versican Plus Pi/L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Maltese: Versican Plus Pi/L4 fih aġġuvant (aluminium hydroxide) biex itejjeb ir-rispons immunitarju.
English: Versican Plus Pi/L4 is a vaccine.
Maltese: Versican Plus Pi/L4 huwa vaċċin.
English: Versican Plus Pi/L4 is available as a lyophilisate (freeze-dried pellet) with solvent for injection.
Maltese: Versican Plus Pi/L4 jiġi bħala lijofilisat (pelit imnixxef bil-friża) b'solvent għal injezzjoni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi/L4 exceed the risks for the approved indications and recommended that Versican Plus Pi/L4 be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Versican Plus Pi/L4 huma akbar mir-riskji għall-indikazzjonijiet approvati u rrakkomanda li Versican Plus Pi/L4 jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: • leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding,
Maltese: • leptospirożi, marda batterjali li tista' tiġi trażmessa permezz ta' awrina infettata u tirriżulta fi fsada,
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi/L4 on 31 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Versican Plus Pi/L4 fil-31 ta' Lulju 2014.
English: What is Versican Plus Pi/L4?
Maltese: X'inhu Versican Plus Pi/L4?
English: What is the risk associated with Versican Plus Pi/L4?
Maltese: X'inhu r-riskju assoċjat ma' Versican Plus Pi/L4?
English: In situations where puppies are expected to inherit very high antibody levels from the bitch the vaccination protocol should be planned accordingly.
Maltese: F'sitwazzjonijiet fejn il-ġriewi huma mistennija li jirtu livelli għoljin ħafna ta' antikorpi mill-kelba, ilprotokoll tat-tilqima għandu jiġi ppjanat kif xieraq.
English: Versican Plus Pi/L4 is used to protect dogs against:
Maltese: Versican Plus Pi/L4 jintuża biex jipproteġi lill-klieb kontra:
English: This summary was last updated in 09-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'09-2017.
English: The full EPAR for Onbrez Breezhaler 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 medicine contains the active substance indacaterol.
Maltese: Il-mediċina fiha s-sustanza attiva indakaterol.
English: The increase in FEV1 was 130 ml with tiotropium, and 80 ml with formoterol.
Maltese: Iż-żieda fl-FEV1 kienet ta' 130 ml b'tiotropium, u ta' 80 ml b'formoterol.
English: The active substance in Onbrez Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Maltese: Is-sustanza attiva f'Onbrez Breezhaler, l-indakaterol, hija agonista tar-riċettur ta' beta-2 adrenerġiku.
English: Onbrez Breezhaler indacaterol
Maltese: Onbrez Breezhaler indakaterol
English: This is a summary of the European public assessment report (EPAR) for Onbrez Breezhaler.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Onbrez Breezhaler.
English: Overall, the effects of the 150 and 300 microgram doses of Onbrez Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Maltese: B'mod ġenerali, l-effetti tad-dożi ta' 150 u ta' 300 mikrogramma ta' Onbrez Breezhaler kienu simili, iżda r-riżultati wrew li d-doża ta' 300 mikrogramma tista' tipprovdi aktar solljev f'pazjenti b'mard iktar serju.
English: European Commission granted a marketing authorisation valid throughout the European Union for Onbrez Breezhaler on 30 November 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Onbrez Breezhaler fit-30 ta' Novembru 2009.
English: On average, the increase in FEV1 in patients who received Onbrez Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Maltese: Bħala medja, iż-żieda fl-FEV1 f'pazjenti li ngħataw Onbrez Breezhaler kienet ta' bejn 150 u 190 ml, filwaqt li għal pazjenti li ngħataw plaċebo t-tibdil fl-FEV1 kien ivarja minn tnaqqis ta' 10 ml sa żieda ta' 20 ml.
English: Onbrez Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Maltese: Onbrez Breezhaler huwa mediċina li tintuża biex iżżomm il-passaġġi tal-arja miftuħin f'adulti b'mard pulmonari ostruttiv kroniku (COPD).
English: Other information about Onbrez Breezhaler
Maltese: Informazzjoni oħra dwar Onbrez Breezhaler
English: The doctor may increase the dose to one 300 microgram capsule once a day in cases of severe COPD.
Maltese: F'każijiet ta' COPD serja t-tabib jista' jżid id-doża għal kapsula ta' 300 mikrogramma darba kuljum.
English: The recommended dose is one 150 microgram capsule, once a day at the same time each day.
Maltese: Id-doża rakkomandata hija ta' kapsula waħda ta' 150 mikrogramma, darba kuljum dejjem fl-istess ħin.
English: Onbrez Breezhaler is used for maintenance (regular) treatment.
Maltese: Onbrez Breezhaler jintuża għall-kura ta' manutenzjoni (regolari).
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Maltese: Taħdem billi teħel ma' riċetturi ta' beta-2 li jinstabu fiċ-ċelloli tal-muskoli ta' ħafna organi u li jġiegħlu lill-muskoli jirrilassaw.
English: In three main studies involving over 4,000 patients with COPD, Onbrez Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Maltese: Fi tliet studji ewlenin li fihom ħadu sehem 'il fuq minn 4,000 pazjent b'COPD, Onbrez Breezhaler tqabbel ma' plaċebo (kura finta), tiotropium jew formoterol (mediċini oħra li jittieħdu man-nifs li jintużaw għall-kura ta' COPD). Il-kejl ewlieni tal-effikaċja kien ibbażat fuq it-tibdil fil-volumi espiratorji sfurzati tal-pazjenti (FEV1, il-volum massimu ta' arja li persuna tista' tonfoħ 'il barra f'sekonda) wara 12-il ġimgħa.
English: The most common side effects with Onbrez Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Maltese: L-effetti sekondarji l-aktar komuni b'Onbrez Breezhaler (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn) u infezzjoni tal-apparat respiratorju ta' fuq (infezzjoni tal-imnieħer u tal-griżmejn).
English: For the full list of all side effects and restrictions with Onbrez Breezhaler, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Onbrez Breezhaler, ara l-fuljett ta' tagħrif.
English: The Agency also noted that there were no major safety concerns with Onbrez Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Maltese: L-Aġenzija nnotat ukoll li ma kien hemm l-ebda tħassib maġġuri relatat mas-sigurtà b'Onbrez Breezhaler, bl-effetti sekondarji jkunu maniġġabbli u simili għal mediċini agonisti tar-riċettur ta' beta-2 adrenerġiku oħrajn.
English: Why is Onbrez Breezhaler approved?
Maltese: Għalxiex ġie approvat Onbrez Breezhaler?
English: What are the risks associated with Onbrez Breezhaler?
Maltese: X'inhuma r-riskji assoċjati ma' Onbrez Breezhaler?
English: Onbrez Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Maltese: Onbrez Breezhaler kien aktar effettiv mill-plaċebo fit-titjib ta' kif jaħdmu l-pulmuni f'pazjenti b'COPD.
English: How is Onbrez Breezhaler used?
Maltese: Kif jintuża Onbrez Breezhaler?
English: It is not intended to provide practical advice on how to use Onbrez Breezhaler.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Onbrez Breezhaler.
English: Onbrez Breezhaler capsules, which contain a power for inhalation, are only used with a Onbrez Breezhaler inhaler and must not be swallowed.
Maltese: Il-kapsuli ta' Onbrez Breezhaler, li fihom trab li jittieħed man-nifs, jintużaw biss ma' inalatur Onbrez Breezhaler u ma għandhomx jinbelgħu.
English: 20 October 2015 EMA/481797/2015
Maltese: EMA/828117/2015
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom persist for more than one week.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Ottubru 2015
English: Further information on the HMPC assessment of purple coneflower herb medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini li fihom l-Echinacea Vjola, inklużi ddettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Purple coneflower herb is the common name for the flowering aerial parts of the plant Echinacea purpurea (L.) Moench.
Maltese: Echinacea Vjola huwa l-isem komuni għall-partijiet ta' barra li jwarrdu tal-pjanta Echinacea purpurea (L.) Moench.
English: When used for prevention and treatment of common cold, cases of serious allergic reactions (such as Stevens-Johnson syndrome, asthma and anaphylactic shock) have been reported, especially in patients who are atopic (have a predisposition to allergic reactions).
Maltese: Meta tintuża għall-prevenzjoni u l-kura ta' riħ komuni, ġew irrapportati każijiet ta' reazzjonijiet allerġiċi serji (bħas-sindrome ta' Stevens-Johnson, ażżma u xokk anafilattiku), speċjalment f'pazjenti li huma atopiċi (ikollhom predispożizzjoni għal reazzjonijiet allerġiċi).
English: Purple coneflower herb medicines should only be used in adults and adolescents above the age of 12 years.
Maltese: Il-mediċini li fihom l-Echinacea Vjola għandhom jintużaw biss f'adulti u adolexxenti li għandhom iktar minn 12-il sena.
English: Purple coneflower herb medicines must not be used in patients who are hypersensitive (allergic) to purple coneflower or other plants of the Asteraceae (Compositae) family.
Maltese: Il-mediċini li fihom l-Echinacea Vjola ma għandhomx jintużaw f'pazjenti li għandhom sensittività eċċessiva (huma allerġiċi) għall-Echinacea Vjola jew pjanti oħrajn tal-familja Asteraceae (Compositae).
English: Purple coneflower herb
Maltese: Echinacea Vjola
English: What are the risks associated with purple coneflower herb medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom l-Echinacea Vjola?
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawsibbli u hemm evidenza li ilhom jintużaw b'dan il-mod sigur għal mill-inqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: Herbal medicines containing purple coneflower herb preparations are usually available in liquid or solid forms to be taken by mouth and in semi-solid (such as ointments) or liquid forms to be applied to the skin.
Maltese: Il-mediċini erbali li fihom preparazzjonijiet ta' Echinacea Vjola ġeneralment huma disponibbli f'għamla likwida jew solida li għandhom jittieħdu mill-ħalq u f'għamla semi-solida (bħal ingwenti) jew likwida li għandhom jiġu applikati fuq il-ġilda.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of purple coneflower herb.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-Echinacea Vjola.
English: How are purple coneflower herb medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini li fihom l-Echinacea Vjola?
English: Further information on the risks associated with purple coneflower herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini li fihom l-Echinacea Vjola, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: What is purple coneflower herb?
Maltese: X'inhi l-Echinacea Vjola?
English: The HMPC conclusions on the use of purple coneflower herb medicines for superficial wounds are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu tal-mediċini li fihom l-Echinacea Vjola għal feriti superfiċjali huma bbażati fuq l-'użu tradizzjonali' tagħhom.
English: The most relevant clinical trials performed in adults indicated that purple coneflower herb medicines containing the expressed juice to be taken by mouth can prevent and improve the symptoms of cold more rapidly than placebo when taken early.
Maltese: feriti superfiċjali, għandu jiġi kkonsultat tabib jew prattikant tal-kura tas-saħħa kwalifikat jekk issintomi jdumu għal iktar minn ġimgħa.
English: The HMPC concluded that purple coneflower herb medicines to be taken by mouth can be used short term for the prevention and treatment of common colds.
Maltese: L-HMPC innota l-effetti ta' benefiċċju possibbli fuq il-fejqan tal-feriti fl-istudji tal-annimali.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing purple coneflower herb.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing purple coneflower herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom l-Echinacea Vjola titressaq lill-awtoritajiet nazzjonali responsabbli mill-prodotti mediċinali li ser jivvalutaw l-applikazzjoni għall-mediċina erbali u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Annex III Conditions for lifting the suspension
Maltese: Anness III Kundizzjonijiet għat-tneħħija tas-sospensjoni
English: Convincing data to identify a patient population in which the benefits of buflomedil clearly outweigh its identified risks.
Maltese: Dejta konvinċenti biex tidentifika popolazzjoni ta' pazjenti li fuqhom il-benefiċċji tal-buflomedil jegħlbu b'mod ċar ir-riskji identifikati tiegħu.
English: For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Maltese: Biex is-sospensjoni titneħħa, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq jeħtieġu jipprovdu lill-Awtoritajiet Nazzjonali Kompetenti bis-segwenti:
English: EMA/185398/2014 EMEA/H/C/000833
Maltese: EMEA/H/C/000833
English: The tablets contain 100, 200, 400, 600 or 800 micrograms of fentanyl.
Maltese: Il-pilloli fihom 100, 200, 400, 600 jew 800 mikrogrammi ta' fentanil.
English: The full EPAR for Effentora 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: Effentora fentanyl
Maltese: Effentora fentanil
English: In the second study, pain intensity had fallen by 9.7 points at 60 minutes after Effentora and by 4.9 points after placebo.
Maltese: Fit-tieni studju, l-intensità tal-uġigħ naqset b'9.7 punti wara 60 minuta li l-pazjenti kienu ħadu Effentora u b'4.9 punti wara li ħadu l-plaċebo.
English: Each patient ranked their pain intensity on an 11-point scale.
Maltese: Kull pazjent ikklassifika l-intensità tal-uġigħ tiegħu fuq skala ta' 11-il punt.
English: The European Commission granted a marketing authorisation valid throughout the EU for Effentora on 4 April 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Effentora fl4 ta' April 2008.