FrancophonIA/ELRC3.0 huggingface dataset:
English: Latvia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Maltese: Il-Latvja ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Finland ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Maltese: Il-Finlandja ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Belgium SOCOBOM N.V. Louizalaan 149 box 24
Maltese: Louizalaan 149 box 24 1050
English: DICLOFENAC DOC 75mg/3ml
Maltese: Diclofenac sodium DICLOFENAC DOC 75mg/3ml
English: Diclofenacum natricum Dicloberl 75 mg/3 ml solution for injection
Maltese: Diclofenac sodium Dicloberl 75 mg/3 ml solution for injection
English: Diclofenacum natricum Profenac 75 mg/3 ml solution for injection
Maltese: Diclofenac sodium Profenac 75 mg/3 ml solution for injection
English: Diclofenac sodium Diclac-50 Zäpfchen 50mg suppository
Maltese: Diclofenac sodium Diclofenac 50 mg suppositories
English: FARAN LABORATORIES S.A. 17 km Athens-Lamia Achaias şi Trizinas 145 64 Nea Kifisia Greece
Maltese: Ir-Rumanija FARAN LABORATORIES S.A. 17 km Athens-Lamia
English: Italy ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Maltese: L-Italja ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Lithuania ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Maltese: Il-Litwanja ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Diclofenacum natricum Diclogen 100 mg suppositories
Maltese: Diclofenac sodium Diclogen 100 mg suppositories
English: Diclofenac sodium DICLOFENAC TEVA 75 MG / 3 ML
Maltese: Diclofenac sodium DICLOFENAC EG 75mg/3ml
English: Diclofenacum natricum DICLOREUM 50
Maltese: Diclofenac potassju DICUNO 50
English: Diclofenacum natricum Diclomelan 50 mg gastro-resistant tablets
Maltese: Diclofenac sodium Diclomelan 50 mg gastro-resistant tablets
English: Diclofenacum natricum OLFEN-50
Maltese: Diclofenac sodium OLFEN-50
English: Diclofenac sodium Diclofenac Genericon retard 100 mg
Maltese: Diclofenac sodium Diclofenac G.L. retard 100 mg
English: Diclofenacum natricum Olfen 50
Maltese: Diclofenac sodium Olfen 50
English: Docetaxel Zentiva1 (docetaxel)
Maltese: Docetaxel Zentiva1 (doċetaksel)
English: Further information on Docetaxel Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/docetaxel-zentiva.
Maltese: ema.europa.eu/medicines/human/EPAR/docetaxel-zentiva.
English: Docetaxel Zentiva received a marketing authorisation valid throughout the EU on 20 April 2007.
Maltese: Docetaxel Zentiva ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-20 ta' April 2007.
English: 1 Previously known as Docetaxel Winthrop.
Maltese: 1 Qabel magħruf bħala Docetaxel Winthrop.
English: Docetaxel Zentiva has been studied in over 4,000 breast-cancer patients, around 2,000 non-small-celllung-cancer patients, around 2,700 prostate-cancer patients, 457 gastric-adenocarcinoma patients and 897 head- and neck-cancer patients.
Maltese: Docetaxel Zentiva ġie studjat f'aktar minn 4,000 pazjent li għandhom kanċer tas-sider, madwar 2,000 pazjent li għandhom kanċer tal-pulmun b'ċelloli mhux żgħar, madwar 2,700 pazjent li għandhom kanċer tal-prostata, 457 pazjent li għandhom adenokarċinoma gastrika u 897 pazjent li għandhom kanċer fir-ras u fl-għonq.
English: The most common side effects with Docetaxel Zentiva (which may affect more than 1 in 10 people) are neutropenia (low levels of neutrophils, white blood cells that fight infection), anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss) and asthenia (weakness).
Maltese: L-effetti sekondarji l-aktar komuni b'Docetaxel Zentiva (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) huma newtropenija (livelli baxxi ta' newtrofili, ċelloli bojod tad-demm li jiġġieldu linfezzjoni), anemija (għadd baxx ta' ċelloli ħomor tad-demm), stomatite (infjammazzjoni tal-kisja talħalq), dijarea, nawżja (tħossok imdardar), rimettar, alopeċja (telf tax-xagħar) u astenija (dgħufija).
English: Other information about Docetaxel Zentiva
Maltese: Informazzjoni oħra dwar Docetaxel Zentiva
English: Docetaxel Zentiva is used with cisplatin and fluorouracil.
Maltese: Docetaxel Zentiva jintuża ma' cisplatin u fluorouracil.
English: Docetaxel Zentiva is used with cisplatin and fluorouracil (other cancer medicines);
Maltese: Docetaxel Zentiva jintuża ma' cisplatin u fluorouracil (mediċini oħra kontra l-kanċer);
English: Docetaxel Zentiva is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer cannot be treated by greatly reducing the body's production of testosterone (castration-resistant prostate cancer).
Maltese: Docetaxel Zentiva jintuża ma' prednisone jew prednisolone (mediċini antiinfjammatorji) meta lkanċer ma jkunx jista' jiġi kkurat permezz ta' tnaqqis kbir fil-produzzjoni ta' testosteron mill-ġisem (kanċer tal-prostata reżistenti għall-kastrazzjoni).
English: • breast cancer.
Maltese: • kanċer tal-pulmun b'ċelloli mhux żgħar.
English: Docetaxel Zentiva contains the active substance docetaxel.
Maltese: Docetaxel Zentiva fih is-sustanza attiva doċetaksel.
English: What are the risks associated with Docetaxel Zentiva?
Maltese: X'inhuma r-riskji assoċjati ma' Docetaxel Zentiva?
English: As for all medicines, data on the use of Docetaxel Zentiva are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Docetaxel Zentiva hija ssorveljata kontinwament.
English: The active substance in Docetaxel Zentiva, docetaxel, belongs to the group of cancer medicines known as taxanes.
Maltese: Is-sustanza attiva f'Docetaxel Zentiva, id-doċetaksel, tappartjeni għall-grupp ta' mediċini kontra lkanċer magħrufa bħala tassani.
English: Why is Docetaxel Zentiva authorised in the EU?
Maltese: Għalfejn Docetaxel Zentiva ġie awtorizzat fl-UE?
English: What measures are being taken to ensure the safe and effective use if Docetaxel Zentiva?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Docetaxel Zentiva?
English: Docetaxel Zentiva must not be used in patients who have a neutrophil count of less than 1,500 cells/mm3 or who have severe problems with their liver.
Maltese: Docetaxel Zentiva m'għandux jintuża f'pazjenti li għandhom l-għadd ta' newtrofili ta' inqas minn 1,500 ċellola/mm3 jew li għandhom problemi serji bil-fwied tagħhom.
English: For the full list of side effects with Docetaxel Zentiva, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Docetaxel Zentiva, ara l-fuljett ta' tagħrif.
English: How is Docetaxel Zentiva used?
Maltese: Kif jintuża Docetaxel Zentiva?
English: Docetaxel Zentiva is a cancer medicine used to treat the following types of cancer:
Maltese: Docetaxel Zentiva huwa mediċina kontra l-kanċer li tintuża fil-kura tat-tipi ta' kanċer li ġejjin:
English: In most of these studies, Docetaxel Zentiva was combined with other anticancer treatments and compared either with the medicines it is used in combination with or with a combination of different treatments.
Maltese: Fil-biċċa l-kbira ta' dawn l-istudji, Docetaxel Zentiva ġie kkombinat ma' kuri oħra kontra l-kanċer u tqabbel jew ma' mediċini li jintuża f'kombinazzjoni magħhom jew ma' kombinazzjoni ta' kuri differenti.
English: An overview of Docetaxel Zentiva and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Docetaxel Zentiva u għalfejn huwa awtorizzat fl-UE
English: • prostate cancer, when the cancer has spread to other parts of the body (metastatic).
Maltese: • kanċer tal-prostata, meta l-kanċer ikun infirex lejn partijiet oħra tal-ġisem (metastatiku).
English: This authorisation was based on the authorisation granted to Taxotere in 1995 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Taxotere fl-1995 (“kunsens infurmat”).
English: It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Maltese: Jista' jintuża wkoll ma' mediċini oħra kontra l-kanċer (doxorubicin, cyclophosphamide, trastuzumab jew capecitabine), fuq pazjenti li jkunu għadhom ma rċevew l-ebda kura għall-kanċer tagħhom jew wara li kuri oħra ma jkunux ħadmu, skont it-tip u l-istadju tal-kanċer tas-sider li jkun qed jiġi kkurat;
English: Adding Docetaxel Zentiva to other cancer treatments increased the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long the patients survived, in all five types of cancer.
Maltese: Iż-żieda ta' Docetaxel Zentiva ma' kuri oħra kontra l-kanċer żiedet l-għadd ta' pazjenti li l-kanċer tagħhom irrisponda għall-kura, kemm damu jgħixu l-pazjenti mingħajr ma l-marda tagħhom aggravat u kemm damu ħajjin il-pazjenti, fil-ħames tipi kollha ta' kanċer.
English: International non-proprietary name (INN): meloxicam
Maltese: Isem internazzjonali komuni (INN): meloxicam
English: The Committee appointed Ms H. Jukes as rapporteur and Mr G. J. Schefferlie as co-rapporteur.
Maltese: Jukes bħala rapporteur u lis-Sur GJ Schefferlie bħala ko-rapporteur.
English: Opinion following an Article 33(4)
Maltese: Opinjoni wara riferiment għall-Artikolu 33(4)
English: The decentralised procedure (NL/V/0164/003/DC) started on 17 June 2011.
Maltese: Il-proċedura deċentralizzata (NL/V/0164/003/DC) bdiet fis-17 ta' Ġunju 2011.
English: Meloxicam is a Non-Steroidal Anti-Inflammatory Drug.
Maltese: Meloxicam huwa Mediċina Mhux Sterojdali Kontra l-Infjammazzjonijiet.
English: This is a ‘hybrid' application according to Article 13(3) Directive 2001/82/EC, as amended, referring to the centrally authorised reference product Metacam 20 mg/ml solution for injection for cattle, pigs and horses (EU/2/97/004).
Maltese: Din hija applikazzjoni “ibrida” skont l-Artikolu 13(3) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza awtorizzat ċentralment ta' Melosolute 40 mg/ml soluzzjoni għall-injezzjoni għal frat, majjali u żwiemel (UE/2/97/004).
English: The application was submitted to the Netherlands as reference Member State and Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain and the United Kingdom as concerned Member States.
Maltese: L-applikazzjoni ġiet sottomessa fil-Pajjiżi l-Baxxi bħala Stat Membru tar-riferiment u l-Awstrija, il-Belġju, ir-Repubblika Ċeka, id-Danimarka, Franza, il-Ġermanja, lUngerija, l-Irlanda, l-Italja, il-Polonja, Spanja u r-Renju Unit bħala Stati Membri kkonċernati.
English: The applicant, CP-Pharma Handelsgesellschaft mbH, submitted an application for a decentralised procedure for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses.
Maltese: L-applikant, CP-Pharma Handelsgesellschaft mbH, issottometta applikazzjoni għal proċedura deċentralizzata għal Melosolute 40 mg/ml soluzzjoni għall-injezzjoni għal frat, majjali u żwiemel.
English: Opinion following an Article 33(4)0F referral for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses
Maltese: Opinjoni wara riferiment għall-Artikolu 33(4)0F għal Melosolute 40 mg/ml soluzzjoni għall-injezzjoni għal frat, majjali u żwiemel
English: Melosolute 40 mg/ml solution for injection for cattle, pigs and horses contains meloxicam as active ingredient.
Maltese: Melosolute 40 mg/ml soluzzjoni għall-injezzjoni għal frat, majjali u żwiemel fih meloxicam bħala sustanza attiva.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States, Ireland and the United Kingdom, regarding the bioequivalence for the target species pigs.
Maltese: Matul il-proċedura deċentralizzata ġew identifikati riskji potenzjali serji minn żewġ Stati Membri kkonċernati, l-Irlanda u rRenju Unit, fir-rigward tal-bijoekwivalenza għall-ispeċi ta' majjali fil-mira.
English: Therefore, the Committee adopted a negative opinion on 8 November 2012 recommending the refusal of the granting of the marketing authorisation for Melosolute 40 mg/ml solution for injection for the target species pigs.
Maltese: Għalhekk, fit-8 ta' Novembru 2012, ilKumitat adotta opinjoni negattiva li tirrakkomanda li ma tingħatax awtorizzazzazzjoni għat-tqegħid fissuq tas-soluzzjoni ta' Melosolute 40 mg/ml soluzzjoni għall-injezzjoni għall-majjali tal-ispeċi fil-mira.
English: Written explanations were provided by the applicant on 11 September 2012.
Maltese: L-applikant ipprovda spjegazzjonijiet bil-miktub fil-11 ta' Settembru 2012.
English: referral for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses
Maltese: Melosolute 40 mg/ml soluzzjoni għall-injezzjoni għal frat, majjali u żwiemel
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 2 May 2012.
Maltese: Fil-jum 210, dawn il-kwistjonijiet kienu għadhom ma ġewx solvuti, u għalhekk fit-2 ta' Mejju 2012 ingħata bidu għal riferiment skont l-Artikolu 33(1) tad-Direttiva 2001/82/KE għall-grupp ta' Koordinazzjoni għar-Rikonoxximent reċiproku u l-Proċeduri deċentralizzati (Veterinarji) (CMD(v)).
English: On 29 June 2012 the reference Member State, the Netherlands, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Maltese: Fid-29 ta' Ġunju 2012, l-Istat Membru ta' riferiment, il-Pajjiżi l-Baxxi, innotifika lill-Aġenzija Ewropea għall-Mediċini li s-CMD(v) naqas milli jilħaq ftehim dwar il-prodott u rrefera l-kwistjoni lis-CVMP skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE.
English: The active substance is included in veterinary medicinal products currently authorised in the European Union via the centralised authorisation procedure, as well as nationally, for use in cattle, pigs, horses, dogs and cats.
Maltese: Is-sustanza attiva hija inkluża fil-prodotti mediċinali veterinarji li bħalissa huma awtorizzati fl-Unjoni Ewropea permezz tal-proċedura ta' awtorizzazzjoni ċċentralizzata, kif ukoll fuq livell nazzjonali, għall-użu fil-frat, majjali, żwiemel, klieb u qtates.
English: The final opinion was converted into a Decision by the European Commission on 12 February 2013.
Maltese: L-opinjoni finali nqelbet f'Deċiżjoni mill-Kummissjoni Ewropea fit-12 ta' Frar 2013.
English: Day 60 of the CMD(v) procedure was on 29 June 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Maltese: Jum 60 tal-proċedura tas-CMD(v) kien fid-29 ta' Ġunju 2012, u peress li l-Istati Membri kkonċernati naqsu milli jilħqu ftehim dwar il-prodott, il-proċedura ġiet riferuta lis-CVMP.
English: The referral procedure started on 11 July 2012.
Maltese: Il-proċedura ta' riferiment bdiet fil-11 ta' Lulju 2012.
English: Alar Irs (Estonia)
Maltese: Alar Irs (L-Estonja)
English: 19 November 2009
Maltese: 19 ta' Novembru 2009
English: Atacand Plus is also available in the EU under other trade names: Atacand Plus Forte, Atacand Plus Mite, Atacand Zid, Blopresid, Blopress, Blopress Comp, Blopress Forte, Blopress Plus, CoKenzen, Hytacand, Parapres Comp, Parapres Comp Forte, Parapres Plus and Ratacand Plus.
Maltese: Atacand Plus huwa disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħrajn: Atacand Plus Forte, Atacand Plus Mite, Atacand Zid, Blopresid, Blopress, Blopress Comp, Blopress Forte, Blopress Plus, CoKenzen, Hytacand, Parapres Comp, Parapres Comp Forte, Parapres Plus u Ratacand Plus.
English: What is Atacand Plus?
Maltese: X'inhu Atacand Plus?
English: 16 September 2010
Maltese: 16 ta' Settembru 2010
English: Atacand Plus is a medicine that contains two active substances candesartan cilexetil and hydrochlorothiazide.
Maltese: Atacand Plus huwa prodott mediċinali li fih żewġ sustanzi attivi candesartan cilexetil u hydrochlorothiazide.
English: It must also not be given to women in their second or third trimesters of pregnancy or to patients with severe kidney or liver problems, cholestasis (problems with the elimination of bile), gout (a painful inflammation of the joints) and hypokalaemia (low blood potassium levels) or hypercalcaemia (high blood calcium levels).
Maltese: Lanqas ma għandu jingħata lil nisa li jkunu qegħdin fit-tieni u fit-tielet trimestru tat-tqala jew lil pazjenti li għandhom problemi serji fil-kliewi jew fil-fwied, cholestasis (problemi bl-eliminazzjoni tal-likwidu biljari), gotta (infjammazzjoni tal-ġogi bl-uġigħ) u hypokalaemia (livelli baxxi ta' potassju fid-demm) jew hypercalcaemia (livelli ta' kalċju għoli fid-demm).
English: Atacand Plus is authorised in the EU via national procedures.
Maltese: Atacand Plus huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: 4.1 Therapeutic indications
Maltese: 4.1 Indikazzjonijiet terpewtiċi
English: The companies that market these medicines are AstraZeneca and Takeda.
Maltese: Il-kumpaniji li jqiegħdu dawn il-mediċini fis-suq huma AstraZeneca u Takeda.
English: Atacand Plus was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Atacand Plus ġie identifikat bħala li għandu bżonn armonizzazzjoni mill-Grupp ta' Koordinament dwar Proċeduri Reċiproċi u Diċentralizzati - tal-Bniedem (CMD(h)).
English: This means that the doctor should try different tablet strengths until the strength that adequately controls the patient's blood pressure is found.
Maltese: Dan ifisser li t-tabib għandu jipprova qawwiet differenti tal-pilloli sakemm tinstab il-qawwa li tikkontrolla b'mod adegwat il-pressjoni tad-demm tal-pazjent.
English: Dose titration is recommended.
Maltese: Hija rrikmandata t-titrazzjoni tad-doża.
English: Candesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Candesartan huwa ‘antagonista tar-riċettur ta' angiotensin II' li jfisser li jimblokka l-azzjoni tal-ormon fil-ġisem li jismu angiotensin II. Angiotensin II huwa vażokostrittur qawwi (sustanza li traqqaq il-vini tad-demm).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Atacand Plus in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem tal-Aġenzija (CHMP) ikkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni dwar il-preskrizzjoni għal Atacand Plus fl-Unjoni Ewropea(UE).
English: Pieter de Graeff (The Netherlands)
Maltese: 25 ta' Frar 2010
English: The CHMP recommended that Atacand Plus be used to treat essential hypertension in adults whose blood pressure is not optimally controlled by candesartan cilexetil or hydrochlorothiazide alone.
Maltese: Is-CHMP irrakkomanda li Atacand Plus jintuża għall-kura ta' pressjoni għolja essenzjali f'adulti li lpressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod ottimali minn candesartan cilexetil jew minn hydrochlorothiazide waħidhom.
English: The European Medicines Agency has completed a review of Atacand Plus and associated names.
Maltese: Għaliex ġie rivedut Atacand Plus?
English: Atacand Plus must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients or to substances derived from sulfonamide.
Maltese: Atacand Plus ma għandux jintuża f'pazjenti li huma sensittivi żżejjed (allerġiċi) għas-sustanzi attivi, għal kwalunkwe sustanza oħra tiegħu jew għal sustanzi derivati minn sulfonamide.
English: Company responses provided on: 25 February 2010 Opinion date:
Maltese: Data tal-Opinjoni:
English: By blocking the receptors to which angiotensin II normally attaches, candesartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to fall.
Maltese: Billi jimblokka r-riċetturi li s-soltu angiotensin II jeħel magħhom, candesartan iwaqqaf lormon milli jkollu effett, u jħalli l-vini tad-demm jitwessgħu u l-pressjoni tad-demm titbaxxa.
English: pH 3.8-4.5 and osmolality 300-400 mOsm/kg.
Maltese: pH 3.8-4.5 u osmolalità 300-400 mOsm/kg.
English: Citric acid monohydrate Sodium citrate Sodium chloride
Maltese: Citric acid monohydrate Sodium citrate
English: FI-02200 Espoo FINLAND
Maltese: FI-02200
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13/04/2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 13/04/2018
English: EXPIRY DATE EXP: {month/year}
Maltese: DATA TA' SKADENZA EXP: {xahar/sena}
English: Pack sizes: 1, 2, 3, 4, 5, 6, 8 and 10 single-dose containers.
Maltese: Daqsijiet tal-pakketti: 1, 2, 3, 4, 5, 6, 8 u 10 kontenituri ta' doża waħda.
English: 1 x 0.6 ml single-dose container 2 x 0.6 ml single-dose containers 3 x 0.6 ml single-dose containers 4 x 0.6 ml single-dose containers 5 x 0.6 ml single-dose containers 6 x 0.6 ml single-dose containers 8 x 0.6 ml single-dose containers 10 x 0.6 ml single-dose containers
Maltese: 2 x 0.6 ml kontenituri b'doża waħda 3 x 0.6 ml kontenituri b'doża waħda 4 x 0.6 ml kontenituri b'doża waħda 5 x 0.6 ml kontenituri b'doża waħda 6 x 0.6 ml kontenituri b'doża waħda 8 x 0.6 ml kontenituri b'doża waħda 10 x 0.6 ml kontenituri b'doża waħda
English: REPEATED DOSE:
Maltese: DOŻA RIPETUTA
English: Common adverse reactions:
Maltese: Reazzjonijiet avversi komuni:
English: Body surface area (m2)
Maltese: Erja tasSuperfiċje tal-ġisem (m2)
English: 30 mg (equivalent to 34.2 mg ropinirole hydrochloride) Excipients:
Maltese: 30 mg (ekwivalenti għal 34.2 mg ta' ropinirole hydrochloride) Ingredjent(i) ieħor/oħra:
English: An additional dose was administered after 20 minutes to 13% of the dogs because of lack of efficacy.
Maltese: Doża addizzjonali ngħatat wara 20 minuta lil 13% tal-klieb minħabba nuqqas ta' effikaċja.
English: At the target dose of 3.75 mg/m² (equivalent to 2-15 µl/kg bw), a peak plasma concentration (Cmax) of 26 ng/ml is reached 10 to 20 minutes (tmax) after administration.
Maltese: Fid-doża fil-mira ta' 3.75 mg/m² (ekwivalenti għal 2-15 µl/kg ta' piż talġisem), il-konċentrazzjoni massima fil-plażma (Cmax) ta' 26 ng/ml tintlaħaq minn 10 sa 20 minuta (tmax) wara l-għoti.
English: Vomiting starts before the Cmax in plasma is reached; at 4-6 minutes in a pharmacokinetic study in dogs.
Maltese: Ir-rimettar jibda qabel tintlaħaq is-Cmax fil-plażma; wara 4-6 minuti fi studju farmakokinetiku filklieb.
English: Low density polyethylene plastic single-dose container containing 0.6 ml.
Maltese: Kontenitur b'doża waħda magħmul minn polyethylene plastik ta' densità baxxa li fih 0.6 ml.
English: Biotransformation occurs by dealkylation, hydroxylation and subsequent conjugation with glucuronic acid or oxidation to carboxylic acid.
Maltese: Il-bijotrasformazzjoni sseħħ permezz ta' dealkylation, hydroxylation u l-konjugazzjoni sussegwenti bi glucuronic acid jew l-ossidazzjoni għal carboxylic acid.
English: Ropinirole is metabolised by the liver.
Maltese: Ropinirole jiġi metabolizzat mill-fwied.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).