FrancophonIA/ELRC3.0 huggingface dataset:
English: Piperacillin 2g and tazobactam250mg both present as sodium salts.
Maltese: Piperacillin 2g u tazobactam 250mg it-tnejn preżenti bħala mluħa tas-sodium.
English: Powder for solution for injection and infusion contains 2.085g piperacillin sodium equivalent to 2g piperacillin and 0.2683 g tazobactam sodium equivalent to 250 milligrams tazobactam
Maltese: Trab għal soluzzjoni għall-injezzjoni u infużjoni fih 2.085 g ta' piperacillin sodium ekwivalenti għal 2g ta' piperacillin u 0.2683 g ta' tazobactam sodium ekwivalenti għal 250 milligramma ta' tazobactam
English: Piperacillin sodium corresponding to piperacillin 2 g and tazobactam sodium corresponding to tazobactam 0,25 g
Maltese: Piperacillin sodium li jikkorrispondi għal piperacillin 2 g, tazobactam sodium li jikkorrispondi għal tazobactam. 0,25 g
English: Piperacillin sodium corresponding to piperacillin 2 g, tazobactam sodium corresponding to tazobactam 0,25 g.
Maltese: Piperacillin sodium li jikkorrispondi għal piperacillin 2 g, tazobactam sodium li jikkorrispondi għal tazobactam 0,25 g.
English: Piperacillin sodium corresponding to piperacillin 4 g and tazobactam sodium corresponding to tazobactam 0,5 g
Maltese: Piperacillin sodium li jikkorrispondi għal piperacillin 4 g, tazobactam sodium li jikkorrispondi għal tazobactam 0,5 g
English: Tazocin 4,5 g
Maltese: Tazocin 4,5 g 4,5 g
English: 4.17 g sodium piperacillin equivalent to 4 g piperacillin and 0.5366 g sodium tazobactam equivalent to 0.5 g tazobactam.
Maltese: 4.17 ta' sodium piperacillin ekwivalenti għal 4 g ta' piperacillin u 0.5366 g ta' sodium tazobactam ekwivalenti għal 0.5 g ta' tazobactam.
English: 4g/0.5g
Maltese: 4,00/0,5g
English: Piperacillin sodium corresponding to piperacillin 4 g, tazobactam sodium corresponding to tazobactam 0,5 g.
Maltese: Piperacillin sodium li jikkorrispondi għal piperacillin 4 g, tazobactam sodium li jikkorrispondi għal tazobactam 0,5 g.
English: 4 g piperacillin (in form of piperacillin sodium) and 0,5 g tazobactam (in form of tazobactam sodium).
Maltese: 4 g ta' piperacillin (fis-sura ta' piperacillin sodium) u 0,5 g ta' tazobactam (fis-sura ta' tazobactam sodium).
English: 4.170 g piperacillin sodium equivalent to 4 g piperacillin and 0.5366 g tazobactam sodium equivalent to 500 mg tazobactam.
Maltese: 4.170 g piperacillin sodium ekwivalenti għal 4 g ta' piperacillin u 0.5366 g ta' tazobactam sodium ekwivalenti għal 500 mg ta' tazobactam.
English: 4.170 g piperacillin sodium equivalent to 4g piperacillin and 0.5366 g tazobactam sodium equivalent to 500 milligrams tazobactam
Maltese: 4.170 g ta' piperacillin sodium ekwivalenti għal 4g ta' piperacillin u 0.5366 g ta' tazobactam sodium ekwivalenti għal 500 milligramma ta' tazobactam
English: 4.0g/0.5g
Maltese: TAZOCIN 4g/0.5g
English: 4,170 g piperacillin sodium equivalent to 4000 mg of piperacillin and 0.5366 g tazobactam sodium equivalent to 500 mg of tazobactam.
Maltese: 4,170 g piperacillin sodium ekwivalenti għal 4000 mg ta' piperacillin u 0.5366 g ta' tazobactam sodium ekwivalenti għal 500 mg ta' tazobactam.
English: 4.170 g piperacillin sodium equivalent to 4 g piperacillin and 0.5366 g tazobactam sodium equivalent to 500 milligrams tazobactam.
Maltese: 4.170 g piperacillin sodium ekwivalenti għal 4g ta' piperacillin u 0.5366 g ta' tazobactam sodium ekwivalenti għal 500 milligramma ta' tazobactam.
English: Czech Republic
Maltese: Repubblika Ċeka
English: 2 g piperacillin (in form of piperacillin sodium) and 0,25 g tazobactam (in form of tazobactam sodium).
Maltese: 2 g ta' piperacillin (fis-sura ta' piperacillin sodium) u 0,25 g ta' tazobactam (fis-sura ta' tazobactam sodium).
English: Further information on Ivemend 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: This overview was last updated in 05-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi: 05-2018.
English: Ivemend (fosaprepitant) EMA/287844/2018
Maltese: EMA/287844/2018
English: Ivemend received a marketing authorisation valid throughout the EU on 11 January 2008.
Maltese: Ivemend irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU fil-11 ta' Jannar 2008.
English: It contains the active substance fosaprepitant.
Maltese: Dan fih is-sustanza attiva fosaprepitant.
English: What are the risks associated with Ivemend?
Maltese: X'inhuma r-riskji assoċjati ma' Ivemend?
English: Other information about Ivemend
Maltese: Informazzjoni oħra dwar Ivemend
English: Aprepitant has been authorised in the European Union (EU) as Emend since 2003.
Maltese: Aprepitant ilu awtorizzat fl-Unjoni Ewropea (UE) bħala Emend sa mill-2003.
English: The active substance in Ivemend, fosaprepitant, is a ‘prodrug' of aprepitant.
Maltese: Is-sustanza attiva f'Ivemend, fosaprepitant, hija “promediċina” ta' aprepitant.
English: The most common side effects with Ivemend (seen in between 1 and 10 patients in 100) are increased liver enzymes, headache, hiccups, constipation, dyspepsia (heartburn), loss of appetite and fatigue (weakness or tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Ivemend (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma żieda fl-enzimi tal-fwied, uġigħ ta' ras, sulluzzu, stitikezza, dispepsja (ħruq ta' stonku), telf ta' aptit u għeja (dgħufija jew għeja).
English: Aprepitant is a neurokinin 1 (NK1) receptor antagonist.
Maltese: Aprepitant huwa antagonist tar-riċettur tan-newrokinina 1 (NK1).
English: Ivemend must always be given together with other medicines that prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron).
Maltese: Ivemend għandu dejjem jingħata flimkien ma' mediċini oħrajn li jipprevjenu n-nawsja u r-rimettar, inkluż kortikosterojde (bħal dexamethasone) u “antagonista 5-HT3” (bħal ondansetron).
English: As for all medicines, data on the use of Ivemend are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Ivemend hija ssorveljata kontinwament.
English: A main study in 2,000 patients with cancer showed that Ivemend was as effective as a Emend another medicine approved for preventing nausea and vomiting.
Maltese: Studju ewlieni f'2,000 pazjent bil-kanċer wera li Ivemend kien effettiv daqs Emend, mediċina oħra approvata għall-prevenzjoni tan-nawsja u tar-rimettar.
English: Ivemend must not be used at the same time as pimozide (used to treat mental illness), terfenadine and astemizole (used to treat allergy symptoms) and cisapride (used to relieve certain stomach problems).
Maltese: Ivemend m'għandux jintuża fl-istess ħin ma' pimozide (jintuża biex jikkura mard mentali), terfenadine u astemizole (jintużaw biex jikkuraw sintomi ta' allerġija) u cisapride (jintuża biex itaffi ċerti problemi tal-istonku).
English: Ivemend is a medicine for preventing nausea (feeling sick) and vomiting caused by chemotherapy cancer medicines.
Maltese: Ivemend huwa mediċina għall-prevenzjoni ta' nawsja (tħossok ma tiflaħx) u rimettar ikkawżati minn mediċini tal-kanċer tal-kimoterapija.
English: How does Ivemend work?
Maltese: Kif jaħdem Ivemend?
English: For the full list of side effects reported with Ivemend, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Ivemend, ara l-fuljett ta' tagħrif.
English: Around 72% of patients treated with either medicine did not have any nausea or vomiting over the five days after receiving chemotherapy.
Maltese: Madwar 72 % tal-pazjenti kkurati b'waħda millmediċini ma kellhomx nawsja jew rimettar għal ħamest ijiem wara li rċivew il-kimoterapija.
English: It stops a chemical in the body called ‘substance P' from attaching to the NK1 receptors.
Maltese: Dan iwaqqaf sustanza kimika fil-ġisem imsejħa “sustanza P” milli teħel mar-riċetturi NK1. Meta sustanza P teħel ma' dawn ir-riċetturi, din tikkawża nawsja u rimettar.
English: A main study showed that Ivemend was as effective as Emend at preventing nausea and vomiting in patients undergoing chemotherapy and its side effects are considered to be manageable.
Maltese: L-effetti sekondarji rrappurtati b'Ivemend huma evalwati bir-reqqa u tittieħed kull azzjoni meħtieġa biex tipproteġi lill-pazjenti.
English: The European Medicines Agency therefore decided that Ivemend's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Ivemend huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: What benefits of Ivemend have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Ivemend li ħarġu mill-istudji?
English: 20 vials
Maltese: 20 kunjett
English: 1 syringe
Maltese: 1 siringa
English: _ _ 1 Whole virion non-adjuvanted influenza vaccine, inactivated, containing antigen of *: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms hemagglutinin
Maltese: A/Vjetnam/1203/2004 (H5N1) 7.5 mikrogrammi** għal kull doża ta' 0.5 ml * ippropagat f'ċelluli Vero (linja ta' ċelluli kontinwi ta' oriġini mammifera) ** espress f'mikrogrammi ta' emagglutinin
English: Immediate Packaging Content (concentration)
Maltese: Kontenut (konċentrazzjoni)
English: MA (EU) Number (Invented) name
Maltese: Numru ta' l-EU Numru tal-MA
English: Pack size multi-dose vial (glass)
Maltese: Il-pakkett li jmiss mal-prodott
English: Single-dose prefilled syringe (glass) without needle
Maltese: Kunjett b'ħafna dożi (ħġieġ)
English: Further information on Telzir can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Telzir.
Maltese: ema.europa.eu/medicines/human/EPAR/Telzir.
English: It contains the active substance fosamprenavir.
Maltese: Fih is-sustanza attiva fosamprenavir.
English: Telzir has been studied in three main studies involving 1,862 adults.
Maltese: Telzir ġie studjat fi tliet studji ewlenin li involvew 1,862 adult.
English: This overview was last updated in 05-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'05-2019.
English: Telzir is available as tablets (700 mg) and as an oral suspension (50 mg/ml) to be taken by mouth.
Maltese: Telzir jiġi bħala pilloli (700 mg) u bħala sospensjoni orali (50 mg/ml) li jittieħed oralment.
English: Other information about Telzir:
Maltese: Aktar informazzjoni dwar Telzir:
English: In one study, after 48 weeks of treatment, 69% of previously untreated adults taking ritonavir-boosted Telzir (221 out of 322) and 68% of those taking nelfinavir (221 out of 327) had viral loads below 400 copies/ml (considered a low viral load).
Maltese: Fi studju wieħed wara 48 ġimgħa ta' kura, 69% tal-adulti li ma kinux ikkurati qabel li ħadu Telzir imsaħħaħ b'ritonavir (221 minn 322) u 68% ta' dawk li ħadu nelfinavir (221 minn 327) kellhom tagħbijiet virali anqas minn 400 kopja/ml (ikkunsidrata bħala tagħbija virali baxxa).
English: Telzir is an antiviral medicine for treating patients aged 6 years or above who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Telzir huwa mediċina antivirali li tintuża għall-kura ta' pazjenti minn 6 snin 'il fuq infettati bil-virus talimmunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: Telzir must not be used in patients who are taking lurasidone (for schizophrenia and bipolar disorder), paritaprevir (for hepatitis C), simvastatin or lovastatin (for lowering blood cholesterol), rifampicin (for tuberculosis), St John's wort (a herbal preparation for depression and anxiety), or certain medicines that are broken down in the same way as Telzir or ritonavir as Telzir may affect their blood levels.
Maltese: Telzir m'għandux jintuża f'pazjenti li jkunu qed jieħdu l-lurasidone (għall-iskiżofrenja u d-disturb bipolari), paritaprevir (għall-epatite Ċ), simvastatin jew lovastatin (għat-tnaqqis tal-kolesterol fid-demm), rifampicin (għat-tuberkulożi), ilfexfiex tar-raba' (St John's wort - preparazzjoni ta' ħxejjex użata fil-kura tad-dipressjoni u l-ansjetà), jew ċerti mediċini oħra li jitkissru bl-istess mod ta' Telzir jew ritonavir peress li Telzir jista' jaffettwa llivelli tad-demm tagħhom.
English: Similar side effects are seen in younger patients.
Maltese: Effetti sekondarji simili ġew osservati wkoll f'pazjenti iżgħar.
English: Telzir received a marketing authorisation valid throughout the EU on 12 July 2004.
Maltese: Telzir rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fit-12 ta' Lulju 2004.
English: What are the risks associated with Telzir?
Maltese: X'inhuma r-riskji assoċjati ma' Telzir?
English: A similar benefit was also seen in one main study including 57 children aged between 2 and 18 years.
Maltese: Benefiċċju simili deher ukoll fi studju ewlieni wieħed li inkluda 57 tifel u tifla ta' bejn is-2 u t-18-il sena.
English: Ritonavir, another protease inhibitor, is used with Telzir as a ‘booster'.
Maltese: Ritonavir, inibitur tal-proteażi ieħor, jintuża ma' Telzir bħala ‘booster'.
English: The recommended dose for adults (aged 18 years or over) and for patients aged between 6 and 18 years who weigh more than 39 kg is 700 mg twice a day.
Maltese: Id-doża rakkomandata għall-adulti (ta' 18-il sena jew aktar) u għal pazjenti ta' bejn is-sitt snin u t-18-il sena li jiżnu iktar minn 39 kg hija 700 mg darbtejn kuljum.
English: In adults, each dose of Telzir must be given with 100 mg ritonavir, twice a day.
Maltese: Fl-adulti, kull doża ta' Telzir għandha tingħata ma' 100 mg ritonavir, darbtejn kuljum.
English: blocks an enzyme that is involved in the reproduction of HIV.
Maltese: Amprenavir, li fil-passat kien disponibbli fl-UE, jimblokkka enzima involuta fir-riproduzzjoni tal-HIV.
English: The active substance in Telzir, fosamprenavir, is a ‘prodrug' of the protease inhibitor amprenavir, which means that it is converted into amprenavir in the body.
Maltese: Is-sustanza attiva f'Telzir, il-fosamprenavir, hi ‘promediċina' tal-inibitur tal-proteażi amprenavir, li jfisser li din tinbidel f'amprenavir fil-ġisem.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Maltese: Meta l-enzima tiġi mblukkata, il-virus ma jirriproduċix ruħu b'mod normali, u dan inaqqas il-firxa tal-infezzjoni.
English: The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of cholesterol (a type of fat) in the blood.
Maltese: L-effetti sekondarji l-aktar komuni f'adulti li jieħdu Telzir (li dehru f'aktar minn pazjent 1 minn 10) huma dijarrea u żieda fil-livelli ta' kolesterol (tip ta' xaħam) fid-demm.
English: In patients aged between 6 and 18 years who weigh between 25 and 39 kg, the dose depends on body weight.
Maltese: Fil-pazjenti bejn is-sitt snin u t-18-il sena li jiżnu bejn 25 u 39 kg, id-doża tiddependi mill-piż tal-ġisem.
English: Telzir is used in combination with ritonavir and other HIV medicines.
Maltese: Telzir jintuża flimkien ma' ritonavir u mediċini oħra tal-HIV.
English: As for all medicines, data on the use of Telzir are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Telzir hija ssorveljata kontinwament.
English: Telzir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Telzir, meħud flimkien ma' mediċini antivirali oħrajn, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: Similar results were seen in the other study comparing ritonavir-boosted Telzir with ritonavir-boosted lopinavir, with around three-quarters of both groups of previously untreated patients having viral loads below 400 copies/ml.
Maltese: Riżultati simili dehru fl-istudju l-ieħor li qabbel lil Telzmir imsaħħaħ b'ritonavir ma' lopinavir imsaħħaħ b'ritonavir, b'madwar tliet kwarti taż-żewġ gruppi ta' pazjenti li qabel ma kinux ikkurati li kellhom tagħbijiet virali taħt il-400 kopja/ml.
English: The European Medicines Agency concluded that Telzir, which contains a prodrug of amprenavir, is as effective as comparator medicines in reducing viral load.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li Telzir, li fih il-prodroga amprenavir, huwa effettiv daqs il-mediċini komparaturi fit-tnaqqis tat-tagħbija virali.
English: For patients who have taken medicines to treat their HIV infection before and did not respond to that treatment, doctors should only prescribe Telzir once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus's response to any new antiviral medicines that might be prescribed.
Maltese: Tnejn mill-istudji f'pazjenti li ma kinux ikkurati qabel urew li Telzir flimkien ma' mediċini antivirali oħra kien effettiv daqs mediċina komparatur.
English: Patients in these three adult studies also took two reverse-transcriptase inhibitors (another type of antiviral medicine) in addition to Telzir or the medicine Telzir was being compared with.
Maltese: Il-pazjenti f'dawn it-tliet studji fuq l-adulti ħadu wkoll żewġ inibituri ta' traskriptażi inversa (tip ieħor ta' mediċina antivirali) flimkien ma' Telzir jew il-mediċina li tqabblet ma' Telzir.
English: Telzir should not be used in people who are hypersensitive (allergic) to fosamprenavir, amprenavir, any of the other ingredients, or ritonavir.
Maltese: Telzir m'għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal fosamprenavir, amprenavir, għal xi sustanza oħra tagħhom, jew ritonavir.
English: Telzir does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Telzir ma jfejjaqx infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara li ssir lissistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: What measures are being taken to ensure the safe and effective use of Telzir?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Telzir?
English: How does Telzir work?
Maltese: Kif jintuża Telzir?
English: EU (MA) number Invented name
Maltese: Numru UE (MA) Isem ivvintat
English: Target species
Maltese: Speċi filmira
English: EU/1/03/249/016 Vivanza 10 mg Orodispersible tablet blister (alu/alu) 4 x 1 tablets (unit dose)
Maltese: 10 mg Pillola li tinħall fil-ħalq Użu orali folja (alu/alu)
English: MA (EU) Number Invented name
Maltese: Numru tal-MA (EU)
English: Strength Pharmaceutical form Route of administration
Maltese: Qawwa Għamla farmaċewtika
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: EU Number
Maltese: Mnejn għandu jingħata
English: London, June 2008 EMEA/532267/2007- Rev.1
Maltese: Londra, Ġunju 2008 EMEA/532267/2007- Rev.1
English: OPINION FOLLOWING AN ARTICLE 40 REFERRAL FOR SUVAXYN PARVO/E
Maltese: OPINJONI WARA REFERENZA SKOND L-ARTIKOLU 40 GĦAL SUVAXYN PARVO/E
English: The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 17 April 2007.
Maltese: L-Opinjoni tal-CVMP ġiet adottata fis-17 ta' Jannar 2007 u d-Deċiżjoni tal-Kummissjoni sussegwenti fis-17 ta' April 2007.
English: Suvaxyn Parvo/E is indicated for the active immunisation of pigs (gilts and sows) to prevent reproductive disorders caused by porcine parvovirus and to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1.
Maltese: Suvaxyn Parvo/E huwa indikat għat-tilqim attiv fil-ħnieżer (ħnieżer nisa li għadhom ma kellhomx għalla [gilts] u ħnieżer nisa) biex jimpedixxi d-disturbi riproduttivi kkawżati minn parvovirus talqżieqeż u biex inaqqas is-sinjali kliniċi kkawżati minn infezzjonijiet ta' Erysipelothrix rhusiopathiae, serotip 2 u serotip 1.
English: France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/82/EC, as amended, in relation to Suvaxyn Parvo/E.
Maltese: Fil-11 ta' Lulju 2006, Franza nnotifikat lill-EMEA b'Referenza skond l-Artikolu 40 tad-Direttiva talKunsill 2001/82/KE, kif emendata, fir-rigward ta' Suvaxyn Parvo/E.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) started the referral procedure on 19 July 2006.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) beda l-proċedura ta' referenza fid19 ta' Lulju 2006.
English: The CVMP, therefore, recommended that the Marketing Authorisation should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
Maltese: Għaldaqstant, is-CVMP irrakkomanda li l-Awtorizzazzjoni Għat-Tqegħid Fis-Suq għandha tkun varjata biex tnaqqas il-varjabbiltà tat-test tal-qawwa seroloġika fil-ġrieden b'miżuri xierqa bħassostituzzjoni ta' l-użu ta' vaċċin ta' referenza fit-test tal-qawwa seroloġika fil-ġrieden bl-użu ta' serum ta' referenza.
English: The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
Maltese: Ir-referenza tindirizza l-kwistjoni li fl-opinjoni ta' Franza, l-ekwivalenza bejn il-lott tal-vaċċin ta' referenza għat-test tal-qawwa tal-lott ta' erysipelas ivvalidat fid-dossier oriġinali u l-lottijiet tal-vaċċin ta' referenza l-ġodda ma ntwerietx għal dawn iż-żewġ lottijiet u li konsegwentement is-CVMP ħtieġ li jikkunsidra jekk għandux ivarja, jirtira jew jissospendi l-awtorizzazzjoni għat-tqegħid fis-suq.
English: However, it was important to ensure that the pass limits of the potency test do not drift from the original.
Maltese: Madankollu, kien importanti li jiġi żgurat li l-limiti ta' suċċess tat-test tal-qawwa ma jitbegħdux mill-oriġinali.
English: Member State EU/EEA Applicant
Maltese: Stat Membru UE/ŻEE
English: The active substance galantamine, a tertiary alkaloid, is a selective, competitive and reversible inhibitor of acetylcholinesterase (AChE).
Maltese: Is-sustanza attiva galantamine, alkaloid terzjarju, hija inibitur riversibbli, kompetittiv u selettiv ta' acetylcholinesterase (AChE).
English: Three definitions of Cmin were discussed:
Maltese: Ġew diskussi tlett definizzjonijiet ta' Cmin:
English: However none of the 90%CI for this parameter fit into the standard bioequivalence limits.
Maltese: Madankollu xejn mid-90%CI għal dan il-parametru ma qabel mal-limiti standard ta' bijoekwivalenza.
English: This procedure concerns a hybrid application (submitted under Art 10(3) of Directive 2001/83/EC as amended) of galantamine containing prolonged release tablets.
Maltese: Din il-proċedura hija applikazzjoni ibrida (sottomessa skont l-Artikolu 10(3) tad-Direttiva 2001/83/KE kif emendata) għal pilloli b'rilaxx prolungat li fihom galantamine.
English: Whereas
Maltese: Isem
English: A single dose study with the 16 mg dose after a high fat meal Single dose studies with the 8 mg and 16 mg formulations demonstrated bioequivalence with the reference product Reminyl (once daily), not only in the conventional bioequivalence range of 80-125%, but in an even tighter range of 90-111% for both AUCt and Cmax.
Maltese: Studju ta' doża waħda bid-doża ta' 16 mg wara ikel b'ħafna xaħam Studji b'doża waħda bil-formolazzjonijiet ta' 8 mg u 16 mg urew bijoekwivalenza mal-prodott ta' referenza Reminyl (darba kuljum), mhux biss fil-firxa konvenzjonali ta' bijoekwivalenza ta' 80-125%, iżda f'firxa anke aktar stretta ta' 90-111% kemm għall AUCt kif ukoll għal Cmax.
English: It is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
Maltese: Hija indikata għall-kura tas-sintomi ta' dimenzja ħafifa sa moderatament serja tat-tip Alzheimer.
English: • The risk-benefit balance is therefore not positive.
Maltese: • Għalhekk, il-bilanċ benefiċċju-riskju mhuwiex pożittiv.