FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Somavert are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Somavert huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: What measures are being taken to ensure the safe and effective use of Somavert?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Somavert?
English: Acromegaly occurs when the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour.
Maltese: L-akromegalija sseħħ meta l-glandola pitwitarja li tinstab fil-bażi tal-moħħ tipproduċi l-ormon tattkabbir b'mod eċċessiv, ġeneralment minħabba tumur beninn (mhux kanċeruż).
English: Why is Somavert authorised in the EU?
Maltese: Għaliex Somavert huwa awtorizzat fl-UE?
English: In adults, rather than gaining height, overproduction of growth hormone leads to acromegaly, with overgrowth of bone, swelling of soft tissue (such as the hands and feet),
Maltese: eċċessiva tal-ormon tat-tkabbir twassal għal akromegalija, bi tkabbir eċċessiv tal-għadam, nefħa fittessut artab (bħall-idejn u s-saqajn), mard tal-qalb u disturbi oħra.
English: By blocking the receptors, Somavert prevents growth hormone from having an effect, thereby preventing the unwanted growth and other disorders seen in acromegaly.
Maltese: Permezz tal-imblukkar tar-riċetturi, Somavert jipprevjeni l-ormon ta' tkabbir milli jkollu effett, b'hekk jipprevjeni t-tkabbir mhux mixtieq u disturbi oħra li jidhru fl-akromegalija.
English: ATCvet code: QI04AA02.
Maltese: QI04AA02
English: Date of last renewal: 07/01/2016
Maltese: Data tal-aħħar tiġdid: 07/01/2016
English: Disodium hydrogen phosphate dodecahydrate Sodium chloride
Maltese: Potassium dihydrogen phosphate Disodium hydrogen phosphate dodecahydrate Sodium chloride
English: SC
Maltese: S.C.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/03/2011.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 14/03/2011
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Maltese: *(Valur cycling (Ct) ≥ 36 minn metodu RT_PCR validat, jindika li m'hemmx preżenza tal-ġenom virali)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1+8 Ovis suspension for injection for sheep
Maltese: VETERINARJU Zulvac 1+8 Ovis suspensjoni għall-injezzjoni għan-nagħaġ
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Preprinted carton box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun stampata minn qabel 1 x 20 ml, 1 x 100 ml u 1 x 240 ml
English: EU/2/11/120/002
Maltese: EU/2/11/120/002 EU/2/11/120/003
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Per dose of 2 ml:
Maltese: Sustanza(i) mhux attiva(i):
English: Aluminium hydroxide Saponin
Maltese: Aluminium hydroxide, saponin, thiomersal.
English: 1 bottle of 120 doses (240 ml).
Maltese: 1 flixkun wieħed b'120 doża (240 ml).
English: 1 bottle of 50 doses (100 ml).
Maltese: 1 flixkun wieħed b'50 doża (100 ml).
English: High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
Maltese: In-natura u l-għamla tal- ippakkjar li jmiss mal-prodott Kunjetti tal-high density polyethylene (HDPE) ta' 20, 100 jew 240 ml b'għeluq ta' elastomer chlorbutyl u siġill tal-aluminju li fihom 10, 50 jew 120 doża ta' vaċċin.
English: Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Maltese: BTV-1/ALG2006/01 E1 Virus Bluetongue inattivat, serotip 8, strejn BTV-8/BEL2006/02
English: Pack of 1 bottle of 10 doses (20 ml).
Maltese: Pakkett ta' flixkun wieħed b'10 dożi (20 ml).
English: Pack of 1 bottle of 120 doses (240 ml).
Maltese: Pakkett ta' flixkun wieħed b'120 doża (240 ml).
English: To stimulate active immunity against Bluetongue virus, serotypes 1 and 8 in sheep.
Maltese: Biex jistimula immunità attiva kontra l-virus Bluetongue, serotipi 1 u 8, fin-nagħaġ.
English: 240 ml
Maltese: 100 ml 240 ml
English: Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
Maltese: BTV-1/ALG2006/01 E1 RP* ≥ 1 Virus Bluetongue inattivat, serotip 8, strejn
English: OTHER INFORMATION Pack sizes:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by Bluetongue virus, serotypes 1 and 8.
Maltese: Tilqim attiv ta' nagħaġ minn 1.5 xhur 'l fuq għall-prevenzjoni* ta' viremija kkawżata mill-virus Bluetongue, serotipi 1 u 8.
English: PACKAGE LEAFLET: Zulvac 1+8 Ovis suspension for injection for sheep
Maltese: Zulvac 1+8 Ovis suspensjoni għall-injezzjoni għan-nagħaġ
English: Pack of 1 bottle of 50 doses (100 ml).
Maltese: Pakkett ta' flixkun wieħed b'50 doża (100 ml).
English: Pharmacotherapeutic group: Inactivated viral vaccines for sheep, Bluetongue virus.
Maltese: Vaċċini b'virus inattivat għan-nagħaġ, kontra l-virus Bluetongue.
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Maltese: Kull skema ‘tilqim mill-ġdid' għandha tigi miftehma mal-Awtorità Kompetenti jew mal-veterinarju responsabbli, filwaqt li titqies is-sitwazzjoni epidemjoloġika lokali.
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days).
Maltese: Filmaġġoranza tal-każijiet dawn ir-reazzjonijiet iseħħu bħala nefħa ġenerali fis-sit tal-injezzjoni (li ddum mhux aktar minn 7 ijiem) jew bħala għoqiedi li jinħassu (granuloma taħt il-ġilda, li tista' tippersisti għal aktar minn 48 ġurnata).
English: Special warnings for each target species:
Maltese: Prekawzjonijiet speċjali għall-użu:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Maltese: BTV-8/BEL2006/02
English: RP* ≥ 1
Maltese: ATTIVA(I)
English: Avoid bubble formation, as this can be irritating at the site of injection.
Maltese: Evita l-formazzjoni ta' bżieżaq tal-arja, għax dan jista' jikkawża irritazzjoni fis-sit tal-injezzjoni.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista, skont il-liġijiet nazzjonal tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Off-white or pink liquid.
Maltese: Likwidu abjad fl-isfar jew roża.
English: The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 63 days).
Maltese: Fil-maġġoranza tal-każijiet dawn ir-reazzjonijiet iseħħu bħala nefħa ġenerali fis-sit tal-injezzjoni (li ddum għal mhux aktar minn 9 ijiem) jew bħala għoqiedi li jinħassu (granuloma taħt il-ġilda, li tista' tippersisti għal aktar minn 63 ġurnata).
English: Potassium chloride Potassium dihydrogen phosphate
Maltese: Potassium chloride
English: Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Maltese: GĦALL-HRUĠ TAL-LOTT Isem u indirizz tal-manufattur tas-sustanza(i) bijoloġika(ċi) attiva(i) Zoetis Manufacturing & Research Spain, S.L.
English: SPAIN
Maltese: TAMMINISTRA
English: A transient increase in rectal temperature, not exceeding 1.2 °C, may occur commonly during the 24 hours following vaccination.
Maltese: Waqt l-ewwel 24 siegħa wara t-tilqima hija komuni li tista' sseħħ żieda temporanja fit-temperatura tarrektum ta' mhux aktar minn 1.2 °C.
English: 1st injection: from 1.5 months of age.
Maltese: L-ewwel injezzjoni: minn 1.5 xhur 'il fuq.
English: A transient increase in rectal temperature, not exceeding 0.6 °C, may occur during the 24 hours following administration of a two-fold overdose.
Maltese: Waqt l-ewwel 24 siegħa wara t-tilqima hija komuni li tista' sseħħ żieda temporanja fit-temperatura tarrektum ta' mhux aktar minn 1.2°C.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/120/001-003
Maltese: EU/2/11/120/001 EU/2/11/120/002 EU/2/11/120/003
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Maltese: F'din il-kategorija ta' annimali l-vaċċin għandu jintuża biss skont stima tal-benefiċċju/riskju mill-veterinarju responsabbli u/jew skont il-programmi kurrenti studjati mill-Awtorita Kompetenti dwar tilqim kontra l-virus Bluetongue BTV.
English: Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1
Maltese: Virus Bluetongue inattivat, serotip 1, strejn
English: Subcutaneous use.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: PACKAGE SIZE 100 ml
Maltese: Tikketta tal-kunjett 20 ml
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Aluminium hydroxide
English: inhibitors (e.g. phenelzine, tranylcypromine).
Maltese: MAO-B) (eż. phenelzine, tranylcypromine).
English: Date of first authorisation: 17 October 2003 Date of latest renewal: 17 October 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' Ottubru 2003 Data tal-aħħar tiġdid: 17 ta' Ottubru 2008
English: - The active substances of Stalevo are levodopa, carbidopa and entacapone.
Maltese: - Is-sustanzi attivi ta' Stalevo huma levodopa, carbidopa u entacapone.
English: Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Stalevo may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin.
Maltese: Minħabba l-affinità ta' entacapone għaċ-ċitokromju P450 2C9 in vitro (ara sezzjoni 5.2), Stalevo jista' potenzjalment jinterferixxi ma' sustanzi attivi bħal S-warfarin li l-metaboliżmu tagħhom jiddependi minn din l-iso-enzima.
English: The use of glucose oxidase methods may give false negative results for glycosuria.
Maltese: L-użu ta' metodi ta' glucose oxidase jistgħu jagħtu riżultati negattivi foloz għall-glukosurja.
English: Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Maltese: Stalevo huwa disponibbli f'sitt daqsijiet ta' pakketti differenti (10, 30, 100, 130, 175 jew 250 pillola).
English: In the first study, entacapone increased the mean daily ON time by 1 h 20 min (CI 95% 45 min, 1 h 56 min) from baseline.
Maltese: Fl-ewwel studju, entacapone żied il-medja tal-perjodu ON ta' kuljum b'1 h 20 min (CI95% 45 min, 1 h 56 min) mill-linja bażi.
English: Magyarország Orion Pharma Kft.
Maltese: Magyarország Orion Pharma
English: - Stalevo may induce orthostatic hypotension.
Maltese: - Stalevo jista' jinduċi pressjoni ortostatika baxxa.
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 1126%].
Maltese: Iżda, fi studju dwar l-interazzjoni f'voluntiera f'saħħithom, entacapone ma biddilx il-livelli fil-plażma ta' S-warfarin, filwaqt li l-AUC ta' R-warfarin żdiedet b'medja ta' 18% [CI90 11-26%].
English: Tel: +386 (0) 1 600 8015
Maltese: Orion Pharma d.o.o. Tel: +386 (0) 1 600 8015
English: Stalevo contains sucrose
Maltese: Stalevo fih sucrose
English: stalevo 75/18.75/200 mg [carton only]
Maltese: stalevo 75/18.75/200 mg [kartuna biss]
English: - If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
Maltese: - Jekk qed tieħu pilloli ta' Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
English: - Stalevo contains sucrose, and therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: - Stalevo fih sucrose, u għalhekk pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose, assorbiment ħażin ta' glucose-galactose, jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: stalevo 125/31.25/200 mg [carton only]
Maltese: stalevo 125/31.25/200 mg [kartuna biss]
English: stalevo 175/43.75/200 mg [carton only]
Maltese: stalevo 175/43.75/200 mg [kartuna biss]
English: Do not take Stalevo if you are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
Maltese: Tiħux Stalevo jekk qed tieħu ċertu mediċini biex tikkura d-depressjoni (taħlita ta' inibituri selettivi ta' MAO-A u MAO-B, jew inibituri mhux selettivi ta' MAO).
English: Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Stalevo 100 mg/25 mg/200 mg film-coated tablets Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Stalevo 200 mg/50 mg/200 mg film-coated tablets
Maltese: Stalevo 50 mg/12.5 mg/200 mg pilloli miksija b'rita Stalevo 75 mg/18.75 mg/200 mg pilloli miksija b'rita Stalevo 100 mg/25 mg/200 mg pilloli miksija b'rita Stalevo 125 mg/31.25 mg/200 mg pilloli miksija b'rita Stalevo 150 mg/37.5 mg/200 mg pilloli miksija b'rita Stalevo 175 mg/43.75 mg/200 mg pilloli miksija b'rita Stalevo 200 mg/50 mg/200 mg pilloli miksija b'rita
English: Always leave at least an hour between Stalevo tablets, to avoid possible side effects.
Maltese: Dejjem ħalli mill-inqas siegħa bejn pilloli Stalevo, sabiex tevita effetti sekondarji possibbli.
English: stalevo 150/37.5/200 mg [carton only]
Maltese: stalevo 150/37.5/200 mg [kartuna biss]
English: stalevo 50/12.5/200 mg [carton only]
Maltese: stalevo 50/12.5/200 mg [kartuna biss]
English: stalevo 100/25/200 mg [carton only]
Maltese: stalevo 100/25/200 mg [kartuna biss]
English: Stalevo contains sucrose (1.89 mg/tablet).
Maltese: Stalevo fih sucrose (1.89 mg/pillola).
English: 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets per day.
Maltese: 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg jew 150 mg/37.5 mg/200 mg, tiħux aktar minn
English: Pyridoxine, however, is not effective in reversing the actions of Stalevo.
Maltese: Madankollu, Pyridoxine mhux effettiv biex jaqleb l-azzjonijiet ta' Stalevo.
English: Stalevo contains sucrose (2.3 mg/tablet).
Maltese: Stalevo fih sucrose (2.3 mg/pillola).
English: stalevo 200/50/200 mg [carton only]
Maltese: stalevo 200/50/200 mg [kartuna biss]
English: Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.
Maltese: It-tabib tiegħek jista' jagħmel xi testijiet tal-laboratorju regolari waqt kura fit-tul b'Stalevo.
English: Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Maltese: Stalevo huwa ndikat għall-kura ta' pazjenti adulti bil-marda ta' Parkinson u b'oxxillazzjonijiet motorji tat-tmiem tad-doża li mhumiex stabbilizzati fuq kura b'levodopa/inibitur ta' dopa decarboxylase (DDC).
English: Stalevo 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored filmcoated tablets marked with ‘LCE 150' on one side.
Maltese: Stalevo 150 mg/37.5 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ta' lewn aħmar fil-kannella jew fil-griż, b'forma ta' elissi mtawwla u mmarkati b'‘LCE 150' fuq naħa waħda.
English: Detailed information on this medicinal product is available on the website of European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Stalevo 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Pilloli Stalevo 75 mg/18.75 mg/200 mg huma disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130, jew 175 pillola).
English: While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Stalevo strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
Maltese: Filwaqt li l-esperjenza b'doża totali ta' kuljum ta' aktar minn 200 mg carbidopa hija limitata, id-doża massima ta' entacapone rrakkomandata kuljum hija ta' 2,000 mg u għalhekk id-doża massima hija ta' 10 pilloli kuljum għall-qawwiet ta' Stalevo ta' 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg u 150 mg/37.5 mg/200 mg.
English: Stalevo 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175).
Maltese: Stalevo 200 mg/50 mg/200 mg huwa disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130, jew 175 pillola).
English: The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Stalevo or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the postmarketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
Maltese: Ir-reazzjonijiet avversi li ġejjin, elenkati f'Tabella 1, ġew akkumulati kemm minn data miġbura flimkien ta' ħdax-il prova klinika, double-blind li kienu jikkonsistu minn 3230 pazjent (1810 ikkurati b'Stalevo jew entacapone flimkien ma' levodopa/inibitur ta' DDC, u 1420 ikkurati b'plaċebo flimkien ma' levodopa/inibitur ta' DDC jew cabergoline flimkien ma' levodopa/inibitur ta' DDC), kif ukoll mid-data ta' wara t-tqegħid fis-suq wara l-introduzzjoni ta' entacapone fis-suq għall-użu flimkien ta' entacapone u levodopa/inibitur ta' DDC.
English: Stalevo may increase the effects and side effects of certain medicines.
Maltese: Stalevo jista' jżid l-effetti u l-effetti sekondarji ta' xi mediċini.
English: - Coadministration of Stalevo with non-selective monoamine oxidase (MAO-A and MAO-B)
Maltese: - Għoti fl-istess ħin ta' Stalevo ma' inibituri mhux selettivi ta' monoamine oxidase (MAO-A u
English: According to this daily carbidopa dose, the maximum recommended daily dose of Stalevo 175 mg/43.75 mg/200 mg is 8 tablets per day and Stalevo 200 mg/50 mg/200 mg dose is 7 tablets per day.
Maltese: Skont din id-doża ta' kuljum ta' carbidopa, id-doża massima rrakkomandata kuljum ta' Stalevo 175 mg/43.75 mg/200 mg hija 8 pilloli kuljum u ta' Stalevo 200 mg/50 mg/200 mg hija 7 pilloli kuljum.
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 il-portal elettroniku Ewropew tal-mediċini.
English: Discontinuation of Stalevo therapy: If Stalevo treatment (levodopa/carbidopa/entacapone) is discontinued and the patient is transferred to levodopa/DDC inhibitor therapy without entacapone, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Maltese: Jekk kura b'Stalevo (levodopa/carbidopa/entacapone) titwaqqaf u l-pazjent jiġi trasferit għal terapija b'levodopa/inibitur ta' DDC mingħajr entacapone, huwa neċessarju li d-dożaġġ ta' kull kura oħra kontra l-marda ta' Parkinson jiġi aġġustat, speċjalment levodopa, sabiex jintlaħaq livell ta' kontroll suffiċjenti tas-sintomi tal-marda ta' Parkinson.
English: Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.
Maltese: Stalevo mhux irrakkomandat biex jintuża għall-kura ta' sintomi ekstrapiramidali (eż. movimenti involontarji, rogħda, riġidità tal-muskoli u kontrazzjonijiet tal-muskoli) ikkawżati minn mediċini oħra.
English: Stalevo 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Pilloli Stalevo 125 mg/31.25 mg/200 mg huma disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130 jew 175 pillola).
English: - Each Stalevo 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Stalevo 150 mg/37.5 mg/200 mg fiha 150 mg ta' levodopa, 37.5 mg ta'carbidopa u 200 mg ta' entacapone.
English: Stalevo contains sucrose (1.9 mg/tablet).
Maltese: Stalevo fih sucrose (1.9 mg/pillola).
English: The most frequently reported adverse reactions with Stalevo are dyskinesias occurring in approximately 19% of patients; gastrointestinal symptoms including nausea and diarrhoea occurring in approximately 15% and 12% of patients, respectively; muscle, musculoskeletal and connective tissue pain occurring in approximately 12% of patients; and harmless reddish-brown discolouration of urine (chromaturia) occurring in approximately 10% of patients.
Maltese: u 12% tal-pazjenti, rispettivament; uġigħ fil-muskoli, muskolu-skeletriku u tat-tessuti konnettivi li jseħħ f'madwar 12% tal-pazjenti; u bidla li ma tagħmilx ħsara fil-kulur tal-awrina għal lewn kannella fl-aħmar (kromaturja) li sseħħ f'madwar 10% tal-pazjenti.
English: - Each Stalevo 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Stalevo 125 mg/31.25 mg/200 mg fiha 125 mg ta' levodopa, 31.25 mg ta' carbidopa u 200 mg ta' entacapone.
English: Stalevo 125 mg/31.25 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Maltese: Stalevo 125 mg/31.25 mg/200 mg: pilloli ovali, ta' lewn aħmar fil-kannella ċar, immarkati b'‘LCE 125' fuq naħa waħda.
English: - Each Stalevo 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Stalevo 75 mg/18.75 mg/200 mg fiha 75 mg ta' levodopa, 18.75 mg ta' carbidopa u 200 mg ta' entacapone.