FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Palonosetron Accord is indicated in adults for:
Maltese: Palonosetron Accord hu indikat fl-adulti għal:
English: How to store Palonosetron Accord 6.
Maltese: Kif taħżen Palonosetron Accord 6.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil tal-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal web Ewropew tal-mediċini..
English: Pharmacokinetic simulations indicate that the overall exposure (AUC0-∞) of 0.25 mg intravenous palonosetron administered once daily for 3 consecutive days was similar to a single intravenous dose of 0.75 mg, although Cmax of the 0.75 mg single dose was higher.
Maltese: Simulazzjonijiet farmakokinetiċi jindikaw li l-espożizzjoni totali (AUC0-) ta' 0.25 mg ta' palonosetron mogħti fil-vina darba kuljum għal tlitt ijiem konsekuttivi kienet simili għal doża waħda ta' 0.75 mg ġol-vina, għalkemm is-Cmax wara doża waħda ta' 0.75 mg kienet ogħla.
English: In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥ 60 mg/m2, cyclophosphamide > 1,500 mg/m2 and dacarbazine, palonosetron 250
Maltese: Fi studju randomised, double-blind b'total ta' 667 pazjent li kienu qed jingħataw kimoterapija emetoġenika qawwija li kienet tinkludi cisplatin ≥ 60 mg/m2, cyclophosphamide > 1,500 mg/m2 u dacarbazine, palonosetron 250 mikrogramma u 750 mikrogramma kienu mqabbla ma' ondansetron 32 mg mogħti minn ġol-vina f'Jum 1.
English: L/h/kg
Maltese: 4. GĦAMLA
English: There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).
Maltese: Kien hemm rapport tas-sindrome ta' serotonin wara l-użu fl-istess ħin ta' antagoisti ta' 5-HT3 u mediċini serotonerġiċi oħrajn (li jinkludu SSRIs u SNRIs).
English: Uncommon ARs (≥1/1,000 to <1/100)
Maltese: ARs Mhux Komuni (・1/1,000 sa <1/100)
English: Each ml of solution contains 50 micrograms of palonosetron.
Maltese: Kull ml ta' soluzzjoni fih 50 mikrogramma ta' palonosetron.
English: These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).
Maltese: Dawn kienu kklassifikati bħala komuni (≥1/100 sa <1/10) jew mhux komuni (≥1/1,000 sa <1/100).
English: The objective was to evaluate the ECG effects of intravenous administered palonosetron at single doses of 0.25, 0.75 or 2.25 mg in 221 healthy subjects.
Maltese: L-għan kien li jiġu evalwati l-effetti tal-ECG ta' palonosetron mogħti fil-vina f'dożi waħidhom ta' 0.25, 0.75 jew 2.25 mg f'221 persuna b'saħħithom.
English: Available in pack of 1 vial containing 5 ml of solution.
Maltese: Disponibbli f'pakkett ta' kunjett wieħed li jkun fih soluzzjoni ta' 5 ml.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection
Maltese: FARMAĊEWTIKA U KONTENUT Soluzzjoni għall-injezzjoni
English: Corticosteroids Palonosetron has been administered safely with corticosteroids.
Maltese: Kortikosterojdi Palonosetron ingħata b'mod sigur ma' kortikosterojdi.
English: - If you have a personal or family history of alterations in heart rhythm (QT prolongation).
Maltese: Jekk għandek storja medika personali jew fil-familja ta' tibdil fir-rata tar-ritmu tal-qalb (QT itwal milli suppost).
English: While the terminal elimination half-life and mean systemic exposure of palonosetron is increased in the subjects with severe hepatic impairment, this does not warrant dose reduction.
Maltese: Waqt li l-half-life ta' l-eliminazzjoni terminali u lmedja ta' l-espożizzjoni sistemika ta' palonosetron jiżdiedu f'pazjenti b'indeboliment serju tal-fwied, dan ma jiġġustifikax tnaqqis fid-doża.
English: flatulence
Maltese: Pożoloġija
English: Mean maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞) are generally dose-proportional over the dose range of 0.3-90 mcg/kg in healthy subjects and in cancer patients.
Maltese: Ilmedja tal-konċentrazzjoni massima tal-plażma (Cmax) u ż-żona taħt il-kurva ta' konċentrazzjoni-ħin (AUC0-) huma ġeneralment proporzjonali għad-doża fuq il-firxa tad-doża ta' 0.3-90 mcg/kg f'pazjenti b'saħħithom u f'pazjenti bil-kanċer.
English: After a single intravenous dose of 10 micrograms/kg [14C]-palonosetron, approximately 80 % of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40 % of the administered dose, as unchanged active substance.
Maltese: Eliminazzjoni Wara doża waħda ta' 10 mikrogrammi/kg ta' [14C]-palonosetron fil-vina, madwar 80 % tad-doża kienet eliminata fl-awrina bħala sustanza attiva mhux mibdula fi żmien 144 siegħa, li jirrappreżenta madwar 40 % tad-doża mogħtija.
English: A doctor or nurse will normally inject palonosetron accord about 30 minutes before the start of chemotherapy.
Maltese: Tabib jew ners normalment għandhom jinjettaw Palonosetron Accord madwar 30 minuta qabel il-bidu tal-kimoterapija.
English: Most patients were non-naive to chemotherapy (78.5%) across all treatment groups.
Maltese: Il-biċċa l-kbira tal-pazjenti kien rċivew kimoterapija fil-passat (78.5%) fil-gruppi kollha ta' kura.
English: For Palonosetron no clinical data on exposed pregnancies are available.
Maltese: Għal Palonosetron m'hemm l-ebda dejta klinika disponibbli dwar nisa esposti waqt it-tqala.
English: 6 ml Type I tubular clear glass vial, closed with chlorobutyl rubber stopper and sealed with a flip-off aluminium seal.
Maltese: Kunjett tal-ħġieġ ċar tubulari tat-Tip I ta' 6 ml, magħluq b'tapp tal-lastku tal-chlorobutyl u ssiġillat b'siġill tat-tip flip-off ta' l-aluminju.
English: The efficacy of palonosetron for the prevention of chemotherapy-induced nausea and vomiting in paediatric cancer patients was demonstrated in a second non-inferiority pivotal trial comparing a single intravenous infusion of palonosetron versus an intravenous ondansetron regimen.
Maltese: a Koorti bl-intenzjoni-li-tikkura.*(ITT) b L-istudju kien maħsub biex juri non-inferjorità. limitu 'l fuq minn -15 % turi non-inferjorità bejn palonosetron u l-komparatur.
English: In adults, different dose levels are indicated in column title.
Maltese: Fl-adulti, livelli differenti ta' doża huma indikati fl-isem talkolonna.
English: What Palonosetron Accord looks like and contents of the pack Palonosetron Accord solution for injection is a clear, colourless solution supplied in a 6 ml glass vial, closed with chlorobutyl rubber stopper and sealed with a flip-off aluminium seal.
Maltese: Kif jidher Palonosetron Accord u l-kontenut tal-pakkett Is-soluzzjoni għall-injezzjoni ta' Palonosetron Accord hi ċara u bla kulur fornuta f'kunjett tal-ħġieġ ta' 6 ml, magħluq b'tapp tal-lastku tal-chlorobutyl u ssiġillat b'siġill tat-tip flip-off tal-aluminju.
English: - If you are using palonosetron accord in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol,
Maltese: Jekk qed tuża Palonosetron Accord flimkien ma' mediċini oħrajn li jistgħu jikkaġunaw ritmu ta' taħbit tal-qalb mhux floku bħal amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol,chlorpromazine, quetiapine, thioridazine, domperidone.
English: - headache Uncommon
Maltese: Mhux komuni
English: Headache, Dizziness
Maltese: Uġigħ ta' ras
English: Each vial of 5 ml of solution contains 250 micrograms of palonosetron (as hydrochloride).
Maltese: Kull kunjett ta' 5 ml ta' soluzzjoni fih 250 mikrogramma ta' palonosetron (bħala hydrochloride).
English: Palonosetron
Maltese: Iperbilirubinemja
English: Clearancec,
Maltese: Kodiċi ATC:
English: <2y
Maltese: NUMRU(I)
English: • the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Maltese: • prevenzjoni ta' dardir u rimettar marbut ma' kimoterapija tal-kanċer li hi moderatament emetoġenika.
English: Hyperbilirubinaemia
Maltese: Pazjenti Pedjatriċi bil-Kanċer a
English: In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
Maltese: Fi studju kliniku, ma ntweriet l-ebda interazzjoni sinifikanti farmakokinetika bejn doża waħda ta' palonosetron ġol-vina u konċentrazzjoni fl-istat fiss ta' metoclopramide orali, li hu inibitur ta' CYP2D6.
English: EXPIRY DATE
Maltese: DATA TA' SKADENZA EXP:
English: While this study demonstrated that paediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults (see section 4.8).
Maltese: Filwaqt li dan l-istudju wera li pazjenti pedjatriċi jeħtieġu doża ogħla ta' palonosetron mill-adulti biex jiġu evitati nawsja u rimettar ikkaġunati mill-kimoterapija, il-profil tas-sigurtà hu konsistenti malprofil stabbilit fl-adulti (ara sezzjoni 4.8).
English: Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock
Maltese: Sensittività eċċessiva, anafilassi, reazzjonijiet u xokk anafilattiku/ anafilattojde
English: After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45 %
Maltese: Wara l-għoti ġol-vina ta' palonosetron 0.25 mg darba kuljum għal tlett ijiem lil 12-il persuna b'saħħithom, il-medja ( SD) taż-żieda tal-konċentrazzjoni ta' palonosetron fil-plażma minn Jum 1 sa Jum 5 kienet ta' 110  45 %.
English: Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34 %.
Maltese: Wara l-għoti ġol-vina ta' palonosetron 0.25 mg darba kull jumejn għal tlett ijiem lil 11-il pazjent b'kanċer testikulari, il-medja ( SD) taż-żieda tal-konċentrazzjoni fil-plażma minn Jum 1 sa Jum 5 kienet ta' 42  34 %.
English: High doses of palonosetron (each dose causing at least 30 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumours, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumours in rats but not in mice.
Maltese: Dożi qawwija ta' palonosetron (kull doża li tikkawża mill-inqas 30 darba dak li jintuża fil-bnedmin) mogħtija kuljum għal sentejn, ikkawżat rata miżjuda ta' tumuri tal-fwied, neoplażmi endokrinali (fit-tirojde, pitwitarji, fil-frixa, fil-medulla adrenali) u tumuri talġilda fil-firien iżda mhux fil-ġrieden.
English: Urinary retention, glycosuria
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: use
Maltese: ISEM
English: Following single dose intravenous infusion of palonosetron 20 mcg/kg, peak plasma concentrations (CT) reported at the end of the 15 minute infusion were highly variable in all age groups and tended to be lower in patients < 6 years than in older paediatric patients.
Maltese: Wara linfużjoni ġol-vini ta' doża waħda ta' palonosetron 20 mcg/kg, il-konċentrazzjonijiet massimi filplażma (CT) irrappurtati fit-tmiem tal-infużjoni ta' 15-il minuta kienu varjabbli ħafna fil-gruppi kollha ta' età, u kellhom tendenza li jkunu iktar baxxi f'pazjenti ta' < 6 snin milli f'pazjenti pedjatriċi li kellhom aktar żmien.
English: Gender does not affect the pharmacokinetics of palonosetron.
Maltese: 3. GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni.
English: Elevated transaminases-, electrocardiogram QT prolonged
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Palonosetron is a selective high-affinity receptor antagonist of the 5HT3 receptor.
Maltese: Palonosetron hu riċettur selettiv li għandu affinità qawwija u antagonist ta' ricettur 5HT3.
English: The efficacy of palonosetron in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Maltese: Dan il-prodott mediċinali għandu jingħata minn professjonist fil-qasam tal-kura tas-saħħa taħt superviżjoni medika adattata.
English: London, 16 September 2008 EMEA/CHMP/500252/2008
Maltese: Londra, 16 ta' Settembru 2008 EMEA/CHMP/500097/2008
English: Remeron and associated names, 15, 30 and 45 mg tablets, 15, 30 and 45 mg orodispersible tablets, 15 mg/ml oral solution, is a noradrenergic and specific serotonergic antidepressant indicated for the treatment of episodes of major depression.
Maltese: Remeron u ismijiet assoċjati, pilloli ta' 15, 30 u 45 mg, pilloli li jdubu fl-ilma ta' 15, 30 u 45 mg, soluzzjoni orali ta' 15 mg/ml, huwa antidipressant oradrenerġiku u serotonerġiku speċifiku indikat għallkura ta' episodji ta' depressjoni maġġuri.
English: The Marketing Authorisation Holder provided supplementary information on 19 March 2008
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta informazzjoni supplimentari fid-19 ta' Marzu 2008.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Remeron and associated names International Non-Proprietary Name (INN): mirtazapine
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA RIFERIMENT SKONT L-ARTIKOLU 30 GĦAL Remeron u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): mirtazapine
English: On 11 October 2007, N.V. Organon presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet, including quality aspects of the medicinal product Remeron and associated names.
Maltese: Organon ippreżentat lill-EMEA riferment skont l-Artikolu 30 tad-Direttiva 2001/83/KE, kif emendata, sabiex jiġu armonizzati s-Sommarji tal-Karatteristiċi tal-Prodott (SPC), itTikketta u l-Fuljett ta' Tagħrif, inkluż aspetti ta' kwalità tal-prodott mediċinali Remeron u l-ismijiet assoċjati.
English: The procedure started on 15 November 2007.
Maltese: Il-proċedura bdiet fil-15 ta' Novembru 2007.
English: The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Remeron and associated names.
Maltese: Il-CHMP ta opinjoni pożittiva fis-26 ta' Ġunju 2008 u rrakkomanda l-armonizzazzjoni tal-SPC, Tikketta u Fuljett ta' Tagħrif inkluż l-aspetti ta' kwalità għal Remeron u l-ismijiet assoċjati.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Remeron and associated names approved across EU Member States, with respect to treatment of major depressive episodes.
Maltese: Il-bażi tar-riferiment kienet li kien hemm diverġenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) inkluż fl-aspetti ta' kwalità ta' Remeron u l-ismijiet assoċjati approvati madwar l-Istati Membri tal-UE fir-rigward ta' kura ta' episodji dipressivi maġġuri.
English: During its June 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet including the quality aspects was acceptable and that they should be amended.
Maltese: Matul il-laqgħa tiegħu ta' Ġunju 2008, il-CHMP, fid-dawl tad-dejta ġenerali ippreżentata u tad-diskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-proposta għall-armonizzazzjoni tal-SPC, it-Tikketta u lFuljett ta' Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
English: EMA/HMPC/313692/2013
Maltese: EMA/HMPC/313692/2013 Il-Kumitat għall-Prodotti Mediċinali Erbali (HPMC)
English: Ispaghula seed
Maltese: Żerriegħa tal-Ispaghula
English: Allergic reactions including rhinitis (runny nose), conjunctivitis (reddening and inflammation of the white of the eye), bronchospasm (excessive and prolonged contraction of the airway muscles) and anaphylaxis (severe allergic reaction) may also occur.
Maltese: Jistgħu jseħħu reazzjonijiet allerġiċi inkluż rinite (flissjoni), konġunktivite (ħmura u infjammazjzoni tal-abjad tal-għajnejn), bronkospażmu (kontrazzjoni eċċessiva u mtawwla tal-muskoli tal-passaġġi tal-arja) u anafilassi (reazzjoni allerġika severa).
English: Side effects have been reported with ispaghula seed medicines, including flatulence and abdominal distension (swelling of the belly).
Maltese: Effetti sekondarji ġew irrapportati b'mediċini taż-żerriegħa tal-ispaghula, inkluż gass u distensjoni addominali (nefħa taż-żaqq).
English: It can be used in adults and children above the age of 6 years.
Maltese: Tista' tintuża f'adulti u tfal li għandhom iktar minn 6 snin.
English: Ispaghula seed is the common name for the seeds of the plant Plantago ovata Forssk.
Maltese: Iż-żerriegħa tal-ispaghula huwa l-isem komuni għaż-żrieragħ tal-pjanta Plantago ovata Forssk.
English: When handling the powder preparation, inhalation of the powder should be avoided as this may lead to allergic sensitization and the potential development of allergies.
Maltese: Meta tkun qed tmiss il-preparazzjoni tat-trab, it-teħid tat-trab man-nifs għandu jiġi evitat minħabba li dan jista' jwassal għal sensitizzazzjoni allerġika u għal żvilupp potenzjali ta' allerġiji.
English: Other information about ispaghula seed medicines
Maltese: Aktar informazzjoni dwar il-mediċini taż-żerriegħa tal-ispaghula
English: What are the risks associated with ispaghula seed medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini taż-żerriegħa tal-ispaghula?
English: The HMPC concluded that ispaghula seed can be used for the treatment of habitual constipation (constipation not caused by a physical change to an organ) and in conditions where softening of the stools is desirable to reduce pain when they are passed, such as anal fissures, haemorrhoids and after surgery to the anus or rectum.
Maltese: L-HMPC ikkonkluda li ż-żerriegħa tal-ispaghula tista' tintuża għall-kura ta' stitikezza abitwali (stitikezza mhux ikkawżata minn tibdil fiżiku għal organu) u f'kundizzjonijiet fejn it-trattib tal-ippurgar huwa mixtieq sabiex jitnaqqas l-uġigħ meta dan jgħaddi, bħal fissuri anali, emorrojdi u wara kirurġija fl-anus jew fir-rektum.
English: Ispaghula husk has been studied in over 900 patients showing effectiveness as a mild laxative.
Maltese: Il-fosdqa tal-ispaghula ġiet studjata fuq aktar minn 900 pazjent, u uriet effikaċja bħala lassattiv ħafif.
English: Further information on the HMPC assessment of ispaghula seed 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: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: What is ispaghula seed?
Maltese: X'inhi ż-żerriegħa tal-ispaghula?
English: Ispaghula seed contains dietary fibre which when mixed with water forms a gel-like mass that works as a mild laxative (medicine used to treat constipation).
Maltese: Iż-żerriegħa tal-ispaghula fiha fibra dietarja li meta titħallat mal-ilma tifforma massa simili għal ġel li taħdem bħala lassattiv ħafif (mediċina użata għall-kura tal-istitikezza).
English: How are ispaghula seed medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini taż-żerriegħa tal-ispaghula?
English: Further information on the risks associated with ispaghula seed 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 taż-żerriegħa tal-ispaghula, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: Herbal medicines containing ispaghula seed are usually available in solid forms to be taken by mouth.
Maltese: Mediċini erbali li fihom iż-żerriegħa tal-ispaghula normalment huma disponibbli f'forom solidi sabiex jittieħdu mill-ħalq.
English: The data on ispaghula husk support therefore the use of ispaghula seed as a laxative.The effectiveness of ispaghula seed in softening stools is based on its laxative effects and no specific data are available.
Maltese: L-effikaċja tażżerriegħa tal-ispaghula fit-trattib tal-ippurgar hija bbażata fuq l-effetti lassattivi tagħha u ma hemm ebda dejta speċifika disponibbli.
English: In its assessment of ispaghula seed to treat constipation, the HMPC considered a number of clinical studies that were carried out with ispaghula husk which contains the same ingredients.
Maltese: Il-konklużjonijiet tal-HMPC jiġu kkunsidrati mill-Istati Membri tal-UE waqt l-evalwazzjoni tal-applikazzjonijiet għalliċenzjar ta' mediċini erbali li fihom iż-żerriegħa tal-ispaghula.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ispaghula seed.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali taż-żerriegħa tal-ispaghula.
English: What evidence supports the use of ispaghula seed medicines?
Maltese: X'evidenza tappoġġa l-użu tal-mediċini taż-żerriegħa tal-ispaghula?
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Maltese: Jiġi f'pilloli (250 mg, 500 mg, 750 mg u 1,000 mg).
English: The full EPAR for Levetiracetam Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Levetiracetam Teva jista' jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The active substance in Levetiracetam Teva, levetiracetam, is an epilepsy medicine.
Maltese: Is-sustanza attiva f'Levetiracetam Teva, il-levetiracetam, hija mediċina tal-epilessija.
English: Levetiracetam Teva is a ‘generic medicine'.
Maltese: Levetiracetam Teva huwa ‘mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Teva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Levetiracetam Teva.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Teva has been shown to have comparable quality and to be bioequivalent to Keppra.
Maltese: Is-CHMP ikkonkluda li, b'konformità mar-rekwiżiti tal-UE, intwera li l-kwalità ta' Levetiracetam Teva hija komparabbli u li huwa bijoekwivalenti għal Keppra.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
Maltese: • aċċessjonijiet mijokloniċi (qosra, movimenti spasmodiċi donnhom xokkijiet ta' muskolu jew ta' grupp ta' muskoli) f'pazjenti minn tnax-il sena 'l fuq li jbatu bl-epilessija mijoklonika ġuvenili;