FrancophonIA/ELRC3.0 huggingface dataset:
English: Tuberculosis is rare in the EU, and Deltyba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 1 February 2008.
Maltese: It-tuberkulożi hija rari fl-UE, u Deltyba ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl-1 ta' Frar 2008.
English: What are the risks associated with Deltyba?
Maltese: X'inhuma r-riskji assoċjati ma' Deltyba?
English: As for all medicines, data on the use of Deltyba are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Deltyba hija ssorveljata kontinwament.
English: The safety profile was considered manageable and several measures were introduced to minimise the risks, including a study to confirm the long-term safety.
Maltese: Il-profil tas-sigurtà tqies li jista' jiġi ġestit u ġew introdotti diversi miżuri biex jitnaqqsu r-riskji, inkluż studju biex tiġi kkonfermata s-sigurtà fit-tul.
English: Looking at the results of these follow-up studies together, 2 years after starting treatment 75% of patients who received Deltyba for 6 months or more had no bacteria in their sputum compared with 55% of patients who received Deltyba for 2 months or less.
Maltese: Meta wieħed iħares lejn ir-riżultati ta' dawn l-istudji ta' segwitu flimkien, sentejn wara bdew il-kura, 75 % tal-pazjenti li rċevew Deltyba għal 6 xhur jew aktar ma kellhomx batterji flisputum tagħhom meta mqabbel ma' 55 % tal-pazjenti li rċevew Deltyba għal xahrejn jew inqas.
English: Deltyba is a medicine that is used in adults with tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines).
Maltese: Deltyba huwa mediċina li tintuża f'adulti bit-tuberkulożi li taffettwa lill-pulmun u li hija reżistenti għal ħafna mediċini (reżistenti għal mill-anqas isoniazid u rifampicin, iż-żewġ mediċini standard tattuberkulożi).
English: The Agency noted that an on-going clinical study will provide confirmation on the long-term effectiveness.
Maltese: L-Aġenzija nnutat li studju kliniku kontinwu ser jipprovdi konferma dwar l-effikaċja fit-tul.
English: Deltyba is given for 6 months together with other tuberculosis medicines.
Maltese: Deltyba jingħata għal 6 xhur flimkien ma' mediċini oħra tat-tuberkulożi.
English: The medicine is available as tablets (50 mg) and the recommended dose is two tablets twice a day taken with food.
Maltese: Il-mediċina tiġi bħala pilloli (50 mg) u d-doża rakkomandata hija żewġ pilloli darbtejn kuljum meħuda flimkien mal-ikel.
English: Deltyba must not be used in patients who have low levels of albumin (a blood protein).
Maltese: Deltyba m'għandux jintuża f'pazjenti li jkollhom livelli baxxi ta' albumina (proteina tad-demm).
English: Since Deltyba has been given conditional authorisation, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba.
Maltese: Minħabba li Deltyba ngħata awtorizzazzjoni kondizzjonali, il-kumpanija li tqiegħed Deltyba fis-suq ser twettaq aktar studji sabiex tikkonferma l-effikaċja fit-tul u s-sigurtà ta' Deltyba.
English: What information is still awaited for Deltyba?
Maltese: Liema informazzjoni għadha mistennija għal Deltyba?
English: After 2 months of treatment more than 40% of the patients who were taking Deltyba no longer had the bacteria in their sputum compared with 30% of the patients who were taking placebo.
Maltese: Wara xahrejn ta' kura aktar minn 40 % tal-pazjenti li kienu qed jieħdu Deltyba ma kienx għad fadlilhom il-batterji fl-isputum tagħhom meta mqabbel ma' 30 % tal-pazjenti li kienu qed jieħdu plaċebo.
English: Although the way it works is unclear, delamanid is known to block the production of methoxy-mycolic and ketomycolic acids, two essential components of the cell walls of M. tuberculosis, which will cause the bacteria to die.
Maltese: Għalkemm il-mod kif jaħdem mhuwiex ċar, delamanid huwa magħruf li jimblokka l-produzzjoni ta' aċidi metossimikopliċi u ketomikopliċi, żewġ komponenti essenzjali tal-ħitan taċ-ċelloli ta' M. tuberculosis, li jikkawżaw il-mewt tal-batterji.
English: For the full list of side effects of Deltyba, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Deltyba, ara l-fuljett ta' tagħrif.
English: The company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely to avoid problems such as the development of resistance and side effects on the heart, as well as the risks in pregnancy or women who are breast-feeding.
Maltese: Il-kumpanija li tqiegħed Deltyba fis-suq ser tipprovdi materjal edukattiv għall-professjonisti tal-kura tas-saħħa, li jispjega kif il-mediċina tintuża b'mod sigur biex jiġu evitati problemi bħall-iżvilupp ta' reżistenza u effetti sekondarji fuq il-qalb, kif ukoll ir-riskji fit-tqala jew f'nisa li qed ireddgħu.
English: Side effects reported with Deltyba are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Deltyba huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How is Deltyba used?
Maltese: Kif jintuża Deltyba?
English: 1 vial + 1 vial
Maltese: Daqs talpakkett kunjett wieħed + kunjett wieħed pinna waħda mimlija għal-lest + 14-il labra
English: Sixmo (buprenorphine)
Maltese: Sixmo (buprenorfina)
English: Further information on Sixmo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sixmo.
Maltese: ema.europa.eu/medicines/human/EPAR/sixmo.
English: It contains the active substance buprenorphine.
Maltese: Fih is-sustanza attiva buprenorfina.
English: Other information about Sixmo
Maltese: Informazzjoni oħra dwar Sixmo
English: During the 6 months of treatment, the percentage of negative urine tests for opioids was around 31% for Sixmo, 13% for placebo and 33% for sublingual buprenorphine.
Maltese: Matul is-6 xhur ta' kura, ilperċentwal ta' testijiet tal-urina negattivi għall-oppjodi kienet madwar 31 % għal Sixmo, 13 % għal plaċebo u 33 % għal buprenorfina ta' taħt l-ilsien.
English: Sixmo must not be used together with medicines known as ‘opioid antagonists' (naltrexone and nalmefene).
Maltese: Sixmo ma għandux jintuża flimkien ma' mediċini magħrufa bħala “antagonisti oppjojde” (naltrexone u nalmefene).
English: The third study compared Sixmo with sublingual buprenorphine in 177 patients whose opioid dependence was already being managed with sublingual buprenorphine at a daily dose of up to 8 mg. After 6 months of treatment, around 96% of patients who received Sixmo responded to treatment (i.e. there was no evidence of opioid use in at least 4 out of 6 months) compared with around 88% in patients on sublingual buprenorphine.
Maltese: Wara 6 xhur ta' kura, madwar 96 % tal-pazjenti li ngħataw Sixmo rrispondew għall-kura (jiġifieri ma kien hemm l-ebda evidenza ta' użu ta' oppjojde f'minn tal-inqas 4 mis-6 xhur) meta mqabbla ma' madwar 88 % f'pazjenti fuq buprenorfina ta' taħt l-ilsien.
English: What are the risks associated with Sixmo?
Maltese: X'inhuma r-riskji assoċjati ma' Sixmo?
English: Sixmo is an implant used to treat dependence on opioid drugs such as heroin or morphine.
Maltese: Sixmo huwa mediċina li tintuża għall-kura tad-dipendenza fuq id-drogi oppjojdi bħall-eroina u lmorfina.
English: The active substance in Sixmo, buprenorphine, is a partial opioid agonist (which means that it acts like an opioid but less powerfully).
Maltese: Is-sustanza attiva f'Sixmo, il-buprenorfina, hija agonista parzjali tal-oppjojde (dan ifisser li taġixxi bħal droga tal-oppjojde iżda b'inqas qawwa).
English: Three studies involving a total of 627 patients with opioid dependence showed that Sixmo is effective at reducing patients' intake of opioids.
Maltese: Tliet studji li involvew total ta' 627 pazjent b'dipendenza fuq l-oppjojde wrew li Sixmo huwa effettiv biex inaqqas il-konsum tal-oppjojdi mill-pazjenti.
English: During the first 4 months of treatment, the percentage of negative urine tests for opioids was around 40% for patients treated with Sixmo, compared with around 28% for those treated with placebo.
Maltese: Matul l-ewwel 4 xhur ta' kura, il-perċentwal ta' testijiet tal-urina negattivi għalloppjojdi kien madwar 40 % għall-pazjenti kkurati b'Sixmo, meta mqabbel ma' madwar 28 % għal dawk ikkurati bil-plaċebo.
English: The most common side effects related to the insertion and removal of the implant are pain, itching, bruising, bleeding, reddening of the skin and rash at the site of the implant.
Maltese: L-effetti sekondarji l-aktar komuni relatati malinseriment u t-tneħħija tal-impjant huma wġigħ, ħakk, tbenġil, fsada, ħmura tal-ġilda u raxx fil-post tal-impjant.
English: The company that markets Sixmo will set up an educational programme for doctors who are expected to prescribe Sixmo to provide detailed information about the surgical procedure for the insertion and removal of the implant.
Maltese: Il-kumpanija li tqiegħed Sixmo fis-suq se tistabbilixxi programm edukattiv għat-tobba li mistennija jippreskrivu Sixmo sabiex tiġi pprovduta informazzjoni dettaljata dwar il-proċedura kirurġika għallinseriment u t-tneħħija tal-impjant.
English: As for all medicines, data on the use of Sixmo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Sixmo hija ssorveljata kontinwament.
English: Sixmo must not be used by patients with severe respiratory insufficiency (inability to breathe properly), patients with severe liver problems, and patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms.
Maltese: Sixmo m'għandux jintuża f'pazjenti b'insuffiċjenza respiratorja severa (inabbiltà li jieħdu n-nifs kif suppost), pazjenti bi problemi severi fil-fwied, u f'pazjenti xurbana jew li qed jesperjenzaw sintomi ta' astinenza mill-alkoħol.
English: The side effects of Sixmo are those expected for a buprenorphine medicine and side effects linked to the implant itself are considered manageable.
Maltese: L-effetti sekondarji ta' Sixmo huwa dawk mistennija għal mediċina buprenorfina u l-effetti sekondarji marbuta mal-impjant innifsu huma kkunsidrati maniġġabbli.
English: How does Sixmo work?
Maltese: Kif jintuża Sixmo?
English: The second study in 287 patients who had not received buprenorphine before compared Sixmo with placebo implants and with sublingual buprenorphine (given under the tongue).
Maltese: It-tieni studju fuq 287 pazjent li ma kinux ingħataw buprenorfina qabel qabbel Sixmo ma' impjanti plaċebo u ma' buprenorfina ta' taħt l-ilsien (li tingħata taħt l-ilsien).
English: Sixmo is used in adults who are already stable while taking buprenorphine under the tongue (no more than 8 mg/day), and who are also receiving medical, social and psychological support.
Maltese: Sixmo jintuża f'adulti li diġà huma stabbli filwaqt li jieħdu buprenorfina ta' taħt l-ilsien (mhux aktar minn 8 mg/kuljum), u li qed jirċievu wkoll appoġġ mediku, soċjali u psikoloġiku.
English: The most common side effects with Sixmo (which may affect up to 1 in 10 people) include headache, constipation and difficulty sleeping.
Maltese: L-effetti sekondarji l-aktar komuni b'Sixmo (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma wġigħ ta' ras, stitikezza u diffikultà biex torqod.
English: While the effect of the implants tended to wear off with time in patients not previously treated with buprenorphine, it was maintained in patients who were already stable on low doses of buprenorphine and the use of Sixmo is therefore reserved for these patients.
Maltese: Għaldaqstant il-mediċina tista' tintuża b'mod ikkontrollat biex tgħin fil-prevenzjoni ta' sintomi ta' astinenza u fit-tnaqqis tal-impuls għall-użu ħażin ta' oppjojdi oħra.
English: Side effects reported with Sixmo are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Sixmo huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The main studies showed that Sixmo was more effective than placebo and at least as effective as sublingual buprenorphine at treating opioid dependence.
Maltese: L-istudji ewlenin urew li Sixmo kien aktar effettiv minn plaċebo u tal-inqas kien effettiv daqs buprenorfina ta' taħt l-ilsien fil-kura tad-dipendenza fuq l-oppjojde.
English: For the full list of side effects of Sixmo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Sixmo, ara l-fuljett ta' tagħrif.
English: EMA/683554/2015 EMEA/H/C/000116
Maltese: EMEA/H/C/000116
English: NeoRecormon is available in various strengths from 500 to 50,000 international units (IU).
Maltese: NeoRecormon jiġi f'qawwiet differenti minn 500 sa 50,000 unitajiet internazzjonali (IU).
English: The full EPAR for NeoRecormon 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: • to prevent anaemia in premature babies;
Maltese: • fil-prevenzjoni ta' anemija fi trabi prematuri;
English: The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic renal failure (1,663 patients, including some comparative studies against placebo (a dummy treatment)), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison with no treatment), and in cancer patients (1,204 patients with different types of cancer, comparison with placebo).
Maltese: L-effikaċja ta' NeoRecormon biex jikkura jew jipprevjeni anemija ġiet studjata f'bosta studji inkluż lanemija f'insuffiċjenza kronika tal-kliewi (1,663 pazjent, inkluż xi studji ta' tqabbil mal-plaċebo (kura finta), trasfużjoni tad-demm awtologa (419-il pazjent, tqabbil ma' plaċebo), anemija fi trabi prematuri (177 tarbija, tqabbil ma' ebda kura), u f'pazjenti morda bil-kanċer (1,204 pazjenti b'tipi differenti ta' kanċer, tqabbil ma' plaċebo).
English: It contains the active substance epoetin beta.
Maltese: Fih issustanza attiva epoetina beta.
English: Other information about NeoRecormon
Maltese: Informazzjoni oħra dwar NeoRecormon
English: This is a summary of the European public assessment report (EPAR) for NeoRecormon.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal NeoRecormon.
English: The active substance in NeoRecormon, epoetin beta, is a copy of a human hormone called erythropoietin.
Maltese: Is-sustanza attiva f'NeoRecormo, l-epoetina beta, hija kopja tal-ormon tal-bniedem imsejjaħ eritropojetina.
English: The most common side effects (seen in between 1 and 10 patients in 100) are hypertension (high blood pressure), headache and thromboembolic events (formation of blood clots in the blood vessels).
Maltese: L-effetti sekondarji l-aktar komuni (li dehru f'bejn 1 u 10 pazjenti minn 100) huma ipertensjoni (pressjoni taddemm għolja), uġigħ ta' ras u avvenimenti tromboembolitiċi (formazzjoni ta' emboli tad-demm filvażijiet).
English: What is NeoRecormon?
Maltese: X'inhu NeoRecormon?
English: NeoRecormon was more effective than placebo at increasing haemoglobin levels in patients with various types of anaemia, including those with chronic renal failure.
Maltese: NeoRecormon kien ferm aktar effettiv minn plaċebo (kura finta) fiż-żieda tal-livelli ta' emoglobina f'pazjenti b'tipi varji ta' anemija, inkluż dawk b'insuffiċjenza kronika tal-kliewi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NeoRecormon on 17 July 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal NeoRecormon fis-17 ta' Lulju 1997.
English: NeoRecormon is a medicine that stimulates red-blood-cell growth.
Maltese: NeoRecormon huwa mediċina li tistimula t-tkabbir taċ-ċelloli ħomor tad-demm.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku epoetina beta
English: Why has NeoRecormon been approved?
Maltese: Għaliex ġie approvat NeoRecormon?
English: The types of side effects seen with NeoRecormon depend on the cause of the patient's anaemia.
Maltese: It-tipi ta' effetti sekondarji b'NeoRecormon jiddependu mill-kawża tal-anemija tal-pazjent.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly);
Maltese: • fil-kura ta' anemija (għadd baxx taċ-ċelloli tad-demm ħomor) li tkun qiegħda tikkawża sintomi fladulti u t-tfal li għandhom ‘insuffiċjenza kronika tal-kliewi' (tnaqqis progressiv fuq perjodu ta' żmien twil, fil-kapaċità tal-kliewi li jaħdmu kif suppost);
English: In patients who are to undergo autologous blood transfusion, NeoRecormon must not be used if they have had a heart attack or stroke within the last month, if they have angina pectoris (a severe type of chest pain), or if they are at risk of deep venous thrombosis (DVT, formation of blood clots in the deep veins of the body, usually in the leg).
Maltese: F'pazjenti li se ssirilhom trasfużjoni tad-demm awtologa, NeoRecormon m'għandux jintuża jekk kellhom attakk ta' qalb jew puplesija f'dan l-aħħar xahar, jekk għandhom anġina pectoris (tip sever ta' uġigħ fis-sider), jew jekk qegħdin f'riskju ta' trombożi venuża fonda (DVT, formazzjoni ta' emboli taddemm fil-vini fondi tal-ġisem, normalment fir-riġel).
English: What is the risk associated with NeoRecormon?
Maltese: X'inhu r-riskju assoċjat ma' NeoRecormon?
English: • to treat anaemia that is causing symptoms in adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer that does not affect the bone marrow);
Maltese: • fil-kura ta' anemija li qed tikkawża s-sintomi f'adulti li qed jingħataw il-kimoterapija għal kanċer 'mhux mjelojde' (kanċer li ma jaffettwax il-mudullun);
English: How has NeoRecormon been studied?
Maltese: Kif ġie studjat NeoRecormon?
English: Erythropoietin is produced by the kidneys and stimulates the production of red blood cells from the bone marrow.
Maltese: L-eritropojetina hija prodotta mill-kliewi u tistimula l-produzzjoni taċ-ċelloli ħomor taddemm mill-mudullun.
English: A risk management plan has been developed to ensure that NeoRecormon is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li NeoRecormon jintuża bl-aktar mod sigur possibbli.
English: For the full list of all side effects reported with NeoRecormon, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'NeoRecormon, ara l-fuljett ta' tagħrif.
English: The epoetin beta in NeoRecormon works in the body in the same way as the natural hormone to stimulate red blood cell production.
Maltese: L-epoetina beta f'NeoRecormon taħdem fil-ġisem bl-istess mod tal-ormon naturali biex tistimula l-produzzjoni taċ-ċelloli ħomor tad-demm.
English: For patients with chronic renal failure, NeoRecormon can be injected into a vein or under the skin, but it must be injected under the skin in premature babies and patients receiving chemotherapy, and into a vein in patients who are going to have their blood extracted for their surgery.
Maltese: Għall-pazjenti b'insuffiċjenza kronika tal-kliewi, NeoRecormon jista' jiġi injettat f'vina jew taħt il-ġilda, iżda għandu jiġi injettat taħt il-ġilda fi trabi prematuri u f'pazjenti li qed jingħataw il-kimoterapija, u f'vina f'pazjenti li se jkollhom id-demm tagħhom estratt għall-intervent kirurġiku tagħhom.
English: • to increase the amount of blood that can be taken from adult patients with moderate anaemia who are going to have an operation and need to have a supply of their own blood before surgery (autologous blood transfusion).This is only done when blood storage procedures are not available or are insufficient because the surgery requires a large volume of blood.
Maltese: • fiż-żieda tal-ammont ta' demm li jista' jittieħed minn pazjenti adulti b'anemija moderata li se ssirilhom operazzjoni u li għandhom bżonn provvista tad-demm tagħhom stess qabel l-intervent kirurġiku (trasfużjoni tad-demm awtologa).
English: The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing carisoprodol;
Maltese: Il-Kumitat ikkonsidra l-proċedura skond l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata, għal prodotti mediċinali kif emendata, għal prodotti mediċinali li fihom carisoprodol;
English: The proof of efficacy for different dosing of carisoprodol and for combination products is missing completely.
Maltese: Il-prova ta' l-effikaċja għal dożi differenti ta' carisoprodol u għal prodotti kombinati hi nieqsa kompletament.
English: On 20 April 2007, the Norwegian Competent Authority (NoMA) issued a Rapid Alert informing the Member States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of the decision by the Marketing Authorisation Holder Actavis to voluntarily withdraw as of 1 May 2008 the Marketing Authorisations for carisoprodol containing medicinal products in its Member State.
Maltese: Fl-20 t'April ta' l-2007, l-Awtorità Kompetenti Norveġiża (in-NoMA) ħarġet Allerta Rapida tgħarraf lill-Istati Membri, lill-EMEA u lill-Kummissjoni Ewropea skond l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata, bid-deċiżjoni ta' Actavis li huma d-Detenturi ta' l-Awtorizzazzjoni għatTqegħid fis-Suq biex volontarjament jirtiraw, mill-1 ta' Mejju ta' l-2008, l-Awtorizzazzjonijiet għatTqegħid fis-Suq għal prodotti mediċinali li fihom carisoprodol fl-Istati Membri.
English: Alternative options are available in the EU for the concerned indications.
Maltese: Fl-UE huma disponibbli opzjonijiet alternattivi għallindikazzjonijiet konċernati.
English: Medicinal products containing carisoprodol have been available in Europe since 1959 and are authorised in a number of EU Member States (see Annex I for the list of carisoprodol containing medicinal products authorised in the EU).
Maltese: Prodotti mediċinali li jkun fihom carisoprodol ilhom disponibbli fl-Ewropa sa mill-1959 u huma awtorizzati f'għadd ta' Stati Membri ta' l-UE (ara l-Anness I għal-lista ta' prodotti mediċinali li fihom carisoprodol awtorizzati fl-UE).
English: The three observational studies published in Norway in 2007 gave evidence for the signals of abuse and impairment identified by the spontaneous reporting system in Norway.
Maltese: It-tliet studji osservattivi ppubblikati fin-Norveġja fl-2007 taw evidenza għassinjali ta' abbuż u problemi identifikati mis-sistema ta' rappurtaġġ spontanju fin-Norveġja.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING CARISOPRODOL (see Annex I)
Maltese: XJENTIFIKA TA' PRODOTTI MEDIĊINALI LI FIHOM CARISOPRODOL (ara l-Anness I)
English: • Data demonstrating convincing efficacy and safety derived from appropriately designed clinical trials (including an active comparator) and data justifying the proposed dose.
Maltese: • Tagħrif li juri effikaċja konvinċenti u sigurtà derivata minn studji kliniċi mfasslin b'mod xieraq (inkluż komparatur attiv) u tagħrif li jiġġustifika d-doża proposta.
English: Acute lower back pain is the only indication that has been documented by three randomised, controlled clinical studies using carisoprodol 350mg performed in the 60's and 70's and which do not fulfill current stardard for the Phase III clinical trials.
Maltese: L-uġigħ fin-naħa t'isfel tad-dahar huwa l-unika indikazzjoni li ġiet dokumentata mit-tliet studji kliniċi kkontrollati randomizzati bl-użu ta' carisoprodol tat-350mg li saru fis-snin 60 u 70 u li ma jissodisfawx l-istandard attwali għall-istudji kliniċi tal-Fażi III.
English: The Marketing Authorisation Holder decided on the voluntary withdrawal on the basis of the assessment performed by the Norwegian Competent Authority.
Maltese: Id-Detentur ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq iddeċieda li jirtiraha volontarjament abbażi tal-valutazzjoni magħmula mill-Awtorità Kompetenti Norveġiża.
English: Carisoprodol is associated with a risk of abuse, psychomotor impairment and intoxication.
Maltese: Carisoprodol huwa assoċjat ma' riskju ta' abbuż, problemi psikomotorji u intossikazzjoni.