FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended starting dose of this medicine for adults and elderly is one to two tablets of 800 mg with each meal, 3 times a day.
Maltese: Id-doża rrakkomandata tal-bidu ta' din il-mediċina għall-adulti u anzjani hi ta' pillola waħda jew żewġ pilloli ta' 800 mg ma' kull ikla, 3 darbiet kuljum.
English: - Keep this leaflet.
Maltese: DATA TA' SKADENZA
English: The first study demonstrated that sevelamer carbonate tablets dosed three times per day was equivalent to sevelamer hydrochloride tablets dosed three times per day in 79 haemodialysis patients treated over two randomised 8 week treatment periods (mean serum phosphorus time-weighted averages were 1.5 ± 0.3 mmol/L for both sevelamer carbonate and sevelamer hydrochloride).
Maltese: L-ewwel studju wera li l-pilloli ta' sevelamer carbonate dożati tleit darbiet kuljum kienu ekwivalenti għal pilloli ta' sevelamer hydrochloride ddożati tliet darbiet kuljum f'79 pazjent ta' emodijaliżi ttrattati fuq żewġ perijodi każwali ta' 8 ġimgħat (fosforu fis-serum medju, b'medji piżati bil-ħin ikunu ta' 1.5 ± 0.3 mmol/l kemm għal sevelamer carbonate u sevelamer hydrochloride).
English: For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Sevelamer carbonate Winthrop should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Maltese: Għal pazjenti li qabel kienu fuq binders tal-fosfat (sevelamer hydrochloride jew dawk bażati fuq kalċju), Sevelamer carbonate Winthrop għandha tingħata fuq bażi ta' gramma għal gramma b'monitoraġġ tal-livelli tal-fosforu sabiex jiġi żgurat li jingħataw l-aqwa dożaġġi kuljum.
English: 30 film-coated tablets
Maltese: TIKKETTA - FLIXKUN TA' 30 PILLOLA
English: Powder for oral suspension 90 sachets
Maltese: U KONTENUT Trab għal suspensjoni orali
English: • rash,
Maltese: • gass
English: Sevelamer carbonate Winthrop powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal.
Maltese: It-trab Sevelamer carbonate Winthrop għal suspensjoni orali huwa trab ta' lewn safrani ċar li jiġi f'qartas tal fojl issiġillat bis-sħana.
English: - Serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have been reported.
Maltese: - Infjammazzjoni serja tal-musrana l-kbira (sintomi jinkludu: uġigħ sever addominali, disturbi fl-istonku jew fl-imsaren jew demm fl-ippurgar [fsada gastrointestinali]) u depożitu ta' kristalli fl-imsaren ġew irrapportati.
English: Each carton contains 90 sachets and a dosing spoon to measure the 0.4 g dose of powder.
Maltese: Kull kartuna fiha 90 qartas u kuċċarina ta' dożaġġ sabiex tiġi kkalkulata d-doża ta' 0.4 g ta' trab.
English: For a 0.8 g dose, the powder for oral suspension should be dispersed in 30 mL of water per sachet.
Maltese: Għal doża ta' 0.8 g, it-trab għal suspenjoni orali għandu jitħallat f'30 ml ilma għal kull qartas.
English: Other side effects have been reported in patients taking Sevelamer carbonate Winthrop:
Maltese: Kellem lit-tabib tiegħek waqt li qed/a tieħu Sevelamer carbonate Winthrop:
English: Since this medicine does not contain calcium your doctor might prescribe additional calcium tablets.
Maltese: Peress li din il-mediċina ma fihiex kalċju t-tabib tiegħek għandu mnejn jippreskrivi pilloli tal-kalċju addizzjonali.
English: EMA/723435/2014 EMEA/H/C/003957
Maltese: EMEA/H/C/003957
English: The studies included 1,159 patients and lasted 26 and 18 weeks, respectively.
Maltese: L-istudji inkludew 1,159 pazjent u damu 26 u 18-il ġimgħa rispettivament.
English: The full EPAR and risk management plan summary for Rasagiline ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In one of the studies, a 26-week treatment with Rasagiline ratiopharm resulted in an average fall of 0.13 points in UPDRS (a standard scale for assessing symptoms of Parkinson's disease) from a starting value of 24.69 compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
Maltese: F'wieħed mill-istudji, kura ta' 26 ġimgħa b'Rasagiline ratiopharm irriżultat fi tnaqqis medju ta' 0.13-il punt f'UPDRS (skala standard biex jiġu evalwati s-sintomi tal-marda ta' Parkinson) minn valur inizjali ta' 24.69 meta mqabbel ma' żieda ta' 4.07 punti fil-pazjenti li kienu qegħdin jieħdu plaċebo minn valur inizjali ta' 24.54.
English: The active substance in Rasagiline ratiopharm, rasagiline, is a ‘monoamine oxidase B inhibitor'.
Maltese: Is-sustanza attiva f‘Rasagiline ratiopharm, ir-rasagilina, hija ”inibitur ta' monoamine oxidase B”.
English: Rasagiline ratiopharm is available as tablets (1 mg).
Maltese: Rasagiline ratiopharm huwa disponibbli bħala pilloli (1 mg).
English: A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.
Maltese: Tnaqqis fil-punteġġ UPDRS jindika titjib fis-sintomi, filwaqt li żieda tindika aggravar tas-sintomi.
English: It is not recommended for patients with moderate liver problems.
Maltese: Mhuwiex irrakkomandat għal pazjenti bi problemi moderati fil-kliewi.
English: Rasagiline ratiopharm contains the active substance rasagiline.
Maltese: Rasagiline ratiopharm fiha s-sustanza attiva rasagilina.
English: It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain.
Maltese: Hija timblokka l-enzima monoamine oxidase tip B, li tkisser in-newrotrażmettitur dopamina fil-moħħ.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasagiline ratiopharm on 12 January 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rasagiline ratiopharm fit-12 ta' Jannar 2015.
English: Rasagiline ratiopharm has been shown in three studies, involving 1,563 patients, to be effective in both relieving the symptoms of Parkinson's disease and in reducing the time patients spend in their ‘off' periods.
Maltese: Rasagiline ratiopharm intwera fi tliet studji, li involvew 1,563 pazjent, li huwa effettiv kemm biex itaffi s-sintomi tal-marda ta' Parkinson kif ukoll biex inaqqas il-ħin li l-pazjenti jqattgħu fil-perjodi ‘off' tagħhom.
English: Rasagiline ratiopharm rasagiline
Maltese: Informazzjoni oħra dwar Rasagiline ratiopharm
English: This is a summary of the European public assessment report (EPAR) for Rasagiline ratiopharm.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rasagiline ratiopharm.
English: Rasagiline ratiopharm is a medicine used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Maltese: Rasagiline ratiopharm huwa mediċina li tintuża għall-kura ta' adulti bil-marda ta' Parkinson (disturb progressiv tal-moħħ li jikkawża rogħda, moviment bil-mod u għebusija tal-muskoli).
English: What are the risks associated with Rasagiline ratiopharm?
Maltese: X'inhuma r-riskji assoċjati ma' Rasagiline ratiopharm?
English: It must also not be used with pethidine (a painkiller).
Maltese: Lanqas ma għandu jintuża ma' pethidine (analġesiku).
English: Why is Rasagiline ratiopharm approved?
Maltese: Għaliex ġie approvat Rasagiline ratiopharm?
English: The company that makes Azilect has agreed that its scientific data can be used for Rasagiline ratiopharm (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Azilect qablet li d-data xjentifika tagħha tista' tintuża għal Rasagiline ratiopharm (“kunsens infurmat”).
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Maltese: Newrotrażmettituri huma kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Maltese: Dawn huma marbuta ma' tnaqqis fl-effett ta' levodopa, meta l-pazjent jesperjenza bidliet f'daqqa bejn li jkun ‘on' u kapaċi jiċċaqlaq, u bejn li jkun ‘off' u jkollu diffikultà biex jiċċaqlaq.
English: Rasagiline ratiopharm can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having ‘fluctuations' towards the end of the period between levodopa doses.
Maltese: Rasagiline ratiopharm jista' jintuża waħdu, jew bħala add-on ma' levodopa (mediċina oħra użata filmarda ta' Parkinson) f'pazjenti li qed ikollhom ”flutwazzjonijiet” lejn it-tmiem tal-perjodu bejn id-dożi ta' levodopa.
English: How is Rasagiline ratiopharm used?
Maltese: Kif jaħdem Rasagiline ratiopharm?
English: Similar reductions in time spent in the ‘off' state were seen in patients taking entacapone.
Maltese: Tnaqqis simili fiż-żmien li qattgħu fl-istat “off” deher f'pazjenti li kienu qed jieħdu entacapone.
English: Rasagiline ratiopharm must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations without prescription such as St John's wort (used to treat depression).
Maltese: Rasagiline ratiopharm m'għandux jintuża ma' inibituri ta' monoamine oxidase oħrajn inklużi mediċini u preparazzjonijiet erbali mingħajr riċetta bħal Fexfiex (jintuża fil-kura ta' dipressjoni).
English: A risk management plan has been developed to ensure that Rasagiline ratiopharm is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Rasagiline ratiopharm jintuża bl-aktar mod sigur possibbli.
English: In the two other studies, Rasagiline ratiopharm was given as ‘add-on' to patients with later stage disease who were already being treated with levodopa, and compared with placebo and another medicine entacapone (also used as add-ons).
Maltese: Fiż-żewġ studji l-oħrajn, Rasagiline ratiopharm ingħata bħala “add-on” lil pazjenti b'marda ta' stadju iktar tard li diġà kienu qed jiġu kkurati b'levodopa, u tqabbel ma' plaċebo u mediċna oħra entacapone (użati wkoll bħala add-ons).
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku rasagilina
English: By increasing levels of dopamine in the parts of the brain that control movement and coordination, Rasagiline ratiopharm improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Maltese: Billi jżid il-livelli ta' dopamina fil-partijiet tal-moħħ li jikkontrollaw il-moviment u lkoordinazzjoni, Rasagiline ratiopharm itejjeb is-sinjali u s-sintomi tal-marda ta' Parkinson, bħal għebusija u moviment bil-mod.
English: There should be at least 14 days between stopping treatment with Rasagiline ratiopharm and starting treatment with another monoamine-oxidase inhibitor or with pethidine.
Maltese: Għandu jkun hemm tal-inqas 14-il ġurnata bejn il-waqfien tal-kura b'Rasagiline ratiopharm u l-bidu tal-kura b'inibitur monoamine-oxidase ieħor jew b'pethidine.
English: Patients with mild liver problems should use Rasagiline ratiopharm with caution and should stop treatment if their liver problems get worse.
Maltese: Pazjenti bi problemi ħfief fil-kliewi għandhom jużaw Rasagiline ratiopharm b'attenzjoni u għandhom iwaqqfu l-kura jekk il-problemi talfwied tagħhom jiggravaw.
English: The standard dose is one tablet once a day.
Maltese: Id-doża standard hija ta' pillola waħda darba kuljum.
English: This is because the
Maltese: Dan
English: Further information on Cortacare 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: Cortacare received a marketing authorisation valid throughout the EU on 27 August 2018.
Maltese: Cortacare ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-27 ta' Awwissu 2018.
English: Cortacare is a ‘hybrid medicine'.
Maltese: Cortacare huwa “mediċina ibrida”.
English: It contains the active substance hydrocortisone aceponate.
Maltese: Huwa fih is-sustanza attiva hydrocortisone aceponate.
English: The active substance in Cortacare, hydrocortisone aceponate, is a corticosteroid or ‘steroid' which acts in the skin cells by stopping the release of chemicals which are involved in inflammation.
Maltese: Is-sustanza attiva f'Cortacare, hydrocortisone aceponate, hija kortikosterojde jew “sterojde” li taġixxi fiċ-ċelloli tal-ġilda billi twaqqaf ir-rilaxx ta' kimiċi involuti fl-infjammazzjoni.
English: The reference medicine for Cortacare is Cortavance.
Maltese: Il-mediċina ta' referenza għal Cortacare hija Cortavance.
English: Other information about Cortacare
Maltese: Informazzjoni oħra dwar Cortacare
English: Cortacare is sprayed onto the affected area of skin at a distance of about 10 cm once daily for a week.
Maltese: Żewġ sprejjaturi huma biżżejjed għall-kura ta' żona tal-ġilda 10 cm b'10 cm.
English: What are the benefits and risks of Cortacare?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Cortacare?
English: How has Cortacare been studied?
Maltese: Kif ġie studjat Cortacare?
English: Cortacare is a corticosteroid veterinary medicine used to treat inflamed and itchy skin conditions in dogs.
Maltese: Cortacare huwa mediċina veterinarja kortikosterojde użata għall-kura ta' kundizzjonijiet ta' infjammazzjoni u ta' ħakk tal-ġilda fil-klieb.
English: Because Cortacare is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Cortacare huwa mediċina ibrida, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk talmediċina ta' referenza.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Cortavance, and do not need to be repeated for Cortacare.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu awtorizzat bil-mediċina ta' referenza, Cortavance, u ma għandhomx għalfejn jiġu ripetuti għal Cortacare.
English: The hydrocortisone in Cortacare is in a special chemical form (di-ester) so the medicine is able to get into the outer layer of the skin and remain there for longer.
Maltese: Il-hydrocortisone f'Cortacare jinsab f'forma kimika speċjali (di-ester) sabiex ilmediċina tkun tista' tidħol fis-saff ta' barra tal-ġilda u ddum aktar hemm.
English: How is Cortacare used?
Maltese: Kif jaħdem Cortacare?
English: There was no need for ‘bioequivalence' studies to investigate whether Cortacare is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' “bijoekwivalenza” biex jiġi investigat jekk Cortacare jiġix assorbit b'mod simili għall-mediċina ta' referenza biex jipproduċi l-istess livell ta' sustanza attiva fid-demm.
English: The precautions are the same as for the reference medicine since Cortacare is a hybrid medicine.
Maltese: Il-prekawzjonijiet huma bħal dawk tal-mediċina ta' referenza minħabba li Cortacare huwa mediċina ġenerika.
English: Two sprays is sufficient to treat an area of skin 10 cm by 10 cm. Care should be taken to avoid spraying the eyes of the dog.
Maltese: Cortacare huwa disponibbli bħala sprej u jista' jinkiseb biss b'riċetta ta' tabib. Cortacare jiġi sprejjat fuq iż-żona tal-ġilda affettwata minn distanza ta' madwar 10 cm darba kuljum għal ġimgħa.
English: Ref. EMEA/727640/2009 EMEA/H/C/1057
Maltese: EMA/727640/2009 EMEA/H/C/1057
English: London, 19 November 2009 Doc.
Maltese: Londra, 19 ta' Novembru 2009 Dok. Ref.
English: It contains the active substance iclaprim.
Maltese: Dan fih is-sustanza attiva iclaprim.
English: The active substance in Mersarex, iclaprim, is an antibiotic of the group ‘dihydrofolate reductase inhibitors'.
Maltese: Is-sustanza attiva f'Mersarex, iclaprim, hija antibijotiku tal-grupp ‘inibituri ta' dihydrofolate reductase'.
English: What is Mersarex?
Maltese: X'inhu Mersarex?
English: Mersarex is a concentrate for solution for infusion (drip into a vein).
Maltese: Mersarex huwa konċentrat għal soluzzjoni għal infużjoni (dripp ġo vina).
English: The application was at day 181 when the company withdrew.
Maltese: L-applikazzjoni kienet fil-ġurnata 181 meta l-kumpanija rtirata.
English: The company presented results from two main studies involving 991 adults with complicated infections of the skin and soft tissues.
Maltese: Il-kumpanija ippreżentat riżultati minn żewġ studji ewlenin li involvew 991 adult b'infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Skont ir-reviżjoni taddokumentazzjoni inizjali, is-CHMP jipprepara lista ta' mistoqsijiet fil-jum 120, u jibgħatha lillkumpanija.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpanija tkun tat risposti għall-mistoqsijiet, is-CHMP jirrevedihom u jista', qabel ma jagħti opinjoni, jistaqsi xi mistoqsijiet li jkun għad hemm fil-jum 180.
English: It was expected to work by blocking the action of a bacterial protein called dihydrofolate reductase.
Maltese: Kien mistenni li jaħdem billi jimblokka l-azzjoni ta' proteina batterjali msejħa dihydrofolate reductase.
English: On 21 October 2009, Arpida A/S officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Mersarex, for the treatment of adults with complicated skin and soft tissue infections.
Maltese: Fil-21 ta' Ottubru 2009, Arpida A/S uffiċjalment innotifikat lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għal tqegħid fis-suq għal Mersarex, għall-kura ta' adulti b'infezzjonijiet ikkumplikati fil-ġilda u fit-tessut artab.
English: Questions and answers on the withdrawal of the marketing authorisation application for Mersarex iclaprim
Maltese: Mistoqsijiet u tweġibiet dwar l-irtirar tal-applikazzjoni għal awtorizzazzjoni għal tqegħid fis-suq għal Mersarex iclaprim
English: What was Mersarex expected to be used for?
Maltese: Kif kien mistenni li jaħdem Mersarex?
English: By blocking the action of dihydrofolate reductase, the medicine was expected to slow down the growth and spread of the bacteria.
Maltese: Billi timblokka l-azzjoni taddihydrofolate reductase, il-mediċina kienet mistennija tnaqqas it-tkabbir u t-tixrid tal-batterji.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Mersarex could not have been approved for the treatment of complicated infections of the skin and the soft tissues.
Maltese: Skont ir-reviżjoni tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Mersarex ma setax jiġi approvat għat-trattament ta' infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob.
English: There were also concerns that the medicine may cause side effects affecting the heart (such as QTc interval prolongation, an alteration of the electrical activity of the heart) and the liver.
Maltese: Kien hemm ukoll tħassib mill-kumpania li l-mediċina tista' tikkawża effetti sekondarji li jaffettwaw il-qalb (bħal titwil tal-intervall QTc, bidla fl-attività elettrika tal-qalb) u lfwied.
English: Bacteria need this protein to produce the active form of folic acid, which they need to multiply.
Maltese: Il-batterji għandhom bżonn ta' din il-proteina biex jipproduċu din il-forma attiva ta' folic acid, li hu bżonnjuż għalihom biex jimmultiplikaw.
English: The effects of Mersarex were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Mersarex għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: The study looked at whether Mersarex given for up to 14 days was as good as linezolid.
Maltese: L-istudju ħares lejn jekk Mersarex mogħti għal sa 14-il jum kienx tajjeb daqs linezolid.
English: Mersarex was expected to be used to treat complicated infections of the skin and the ‘soft tissues' below the skin.
Maltese: Mersarex kien mistenni li jintuża biex jiġu trattati infezzjonijiet ikkumplikati tal-ġilda u tat-'tessuti rotob' taħt il-ġilda.
English: Around half of the patients were treated with Mersarex, while the others were treated with linezolid (another antibiotic).
Maltese: Madwar nofs il-pazjenti ġew ikkurati b'Mersarex, waqt li oħrajn ġew ikkurati b'linezolid (antibijotiku ieħor).
English: Complicated means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Maltese: Ikkumplikati tfisser li l-infezzjoni hija diffiċli biex tiġi kkurata, minħabba li tkun infirxet għat-tessuti li jinsabu fil-fond taħt il-ġilda, jista' jkun hemm bżonn ta' kirurġija, jew il-pazjent għandu kundizzjonijiet oħra li jistgħu jaffettwaw ir-rispons għat-trattament.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Mersarex?
Maltese: X'inhuma l-konsegwenzi tal-irtirar għal pazjenti li jużaw Mersarex fi provi kliniċi jew fi programmi għall-użu ta' kompassjoni?
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues.
Maltese: Wara li s-CHMP kien evalwa rrisposti mill-kumpanija għal lista ta' mistoqsijiet, kien għad hemm xi kwistjonijiet pendenti mhux riżolti.
English: Treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Maltese: Pakkett tal-bidu tat-trattament : 14-il pillola + 14-il pillola + 14-il pillola + 14-il pillola
English: 5 vials
Maltese: 5 fjali
English: 1 bottle + 1 measuring cup + 1 oral syringe + 1 adaptor
Maltese: flixkun wieħed + 1 tazza talkejl + 1 siringa orali + 1 adattur
English: Oral use bottle (glass)
Maltese: Folja (PVC/PVDC/alu)
English: EU/1/19/1383/028 Lacosamide UCB 50 / 100/
Maltese: 10 mg/mL Mistura
English: mg
Maltese: fjala waħda
English: Ref. EMEA/402553/2008
Maltese: EMEA/402553/2008
English: London, 21 August 2008 Doc.
Maltese: Londra, 21 ta' Awwissu 2008 Dok. Ref.
English: International non-proprietary name (INN): ketoprofen
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): ketoprofen
English: The active substance in Diractin, ketoprofen, is a non-steroidal anti-inflammatory drug (NSAID).
Maltese: Is-sustanza attiva f'Diractin, ketoprofen, hija mediċina anti-infjammatorja mhux sterojde (NSAID).
English: Diractin is a medicine that contains the active substance ketoprofen.
Maltese: Diractin huwa mediċina li fiha s-sustanza attiva ketoprofen.
English: What is Diractin?
Maltese: X'inhu Diractin?
English: It was to be available as a gel containing 22.9 mg of ketoprofen per gram of gel.
Maltese: Kellu jkun disponibbli bħala ġell li fih 22.9 mg ta' ketoprofen għal kull gramma tal-ġel.
English: The study compared the effectiveness of three different doses of Diractin (25 mg, 50 mg and 100 mg twice a day) with that of placebo (a dummy treatment).
Maltese: L-istudju qabbel l-effikaċja ta' tliet dożi differenti ta' Diractin (25 mg, 50 mg u 100 mg darbtejn kuljum) ma' dak ta' plaċebo (kura finta).
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: Ladarba l-kumpanija tkun ippreżentat it-tweġibiet tagħha għall-mistoqsijiet imressqa, is-CHMP jirrevedihom u jista', qabel ma jagħti opinjoni, jitlob għal xi mistoqsijiet oħra fil-jum 180.