FrancophonIA/ELRC3.0 huggingface dataset:
English: Only use the 1 ml syringe included in the package.
Maltese: Uża biss is-siringa ta' 1 ml inkluża fil-pakkett.
English: Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ammonium glycyrrhizate Glycerol (E422)
Maltese: Keppra soluzzjoni orali fih methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216) li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jieħdu iż- żmien biex jidhru).
English: Keppra 500 mg film-coated tablets Levetiracetam
Maltese: Keppra 500 mg pilloli miksija b' rita Levetiracetam
English: Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Maltese: Example: jekk id-doża ta' kuljum tiegħek hija 1000 mg, id-doża tal-bidu mnaqqsa tiegħek hija 2 pilloli ta' 250 mg filgħodu u 2 pilloli ta' 250 mg filgħaxija.
English: 3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
Maltese: 3.5 sa 7 mg/kg (0.035 sa 0.07 ml/kg) (0.105 ml/kg)darbtejn kuljum
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation,
Maltese: Attenta ta' suwiċidju, ħsibijiet ta' suwiċidju,mard psikotiċi, mġieba abnormali, alluċinazzjonijiet, rabja, stat konfużjonali , attakk ta' paniku, tibdil flemozzjonijiet/tibdil filburdati, agitazzjoni,
English: Aluminium/PVC perforated unit dose blisters placed into cardboard boxes containing 100 x 1 filmcoated tablet.
Maltese: Folji tal-aluminju/PVC li jistgħu jinqasmu f'dożi singoli f'kaxxi tal-kartun li fihom 100 x 1 pillolamiksija b'rita.
English: Keppra 250 mg film-coated tablets
Maltese: Keppra 250 mg pilloli miksija b'rita
English: 1.8 ml twice daily
Maltese: 1.8 ml darbtejn kuljum
English: The possible side effects of an overdose of Keppra are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Maltese: Wara dożi eċċessivi ta' Keppra, ġew osservati effetti ta' ħedla, aġitazzjoni, aggressjoni, tnaqqisfil-livell ta' kuxjenza, livell baxx tar-rifless respiratorju, u koma.
English: • 500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Maltese: 500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 pillola miksija b'rita u pakketti multipli li fihom 200 (2 paketti ta' 100) pilloli miksija b'rita.
English: 17, Route de Meulan
Maltese: MOD TA' KIF U MNEJN JINGĦATA
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
Maltese: Attenta ta' suwiċidju, ħsibijiet ta' suwiċidju,mard psikotiċi, mġieba abnormali, alluċinazzjonijiet, rabja, stat konfużjonali , attakk ta' paniku, tibdil flemozzjonijiet/tibdil filburdati, agitazzjoni
English: If you stop taking Keppra:
Maltese: Jekk tinsa tieħu Keppra:
English: EU/1/00/146/027 EU/1/00/146/031 EU/1/00/146/032
Maltese: EU/1/00/146/029 EU/1/00/146/034
English: Lifepharma (Z.A.M.)
Maltese: BSA pazjent (m2)
English: 0.3 ml twice daily
Maltese: 0.3 ml darbtejn kuljum
English: • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Maltese: • waħdu f'adulti u addoloxxenti minn 16 il-sena b'epilessija li għadha kif ġiet iddijanjostikata, fit-trattament ta' ċertu forma ta' epilessija.
English: EU/1/00/146/030 (polytetrafluoroethylene -faced stopper) EU/1/00/146/033 (Uncoated stopper)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/146/030 (għatu b'wiċċ tat-Teflon) EU/1/00/146/033 (għatu mhux miksi)
English: • 750 mg: 20, 30, 50, 60, 80, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Maltese: 750 mg: 20, 30, 50, 60, 80, 100 x 1, 100, pillola miksija b'rita u pakketti multipli li fihom 200 (2 paketti ta' 100) pilloli miksija b'rita.
English: Aluminium/PVC blister
Maltese: Ammonium glycyrrhizate
English: Film-coating:
Maltese: Struzzjonijiet għall-użu:
English: EU/1/00/146/026 200 tablets (2 packs of 100) EU/1/00/146/037 100 x 1 tablets
Maltese: EU/1/00/146/026 200 pillola (2 pakketti ta' 100)
English: • 250 mg: 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Maltese: 250 mg: 20, 30, 50, 60, 100 x 1, 100 pillola miksija b'rita u pakketti multipli li fihom 200 (2 paketti ta'
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x 6 - 17 the MRHD on a mg/m2 basis).
Maltese: Studji fl-annimali tat-twelid u ġovanili fil-firien u l-klieb wrew li ma kienx hemm effetti avversi filpunti tat-tmiem standard tal-iżvillup jew maturazzjoni b'dożi sa 1800 mg/kg/ġurnata ( x6 - 17 ilMRHD fuq bażi ta' mg/m2).
English: The initial therapeutic dose is 7 mg/kg twice daily.
Maltese: Id-doża terapewtika tal-bidu hija ta' 7 mg/kg darbtejn kuljum.
English: Height (cm) x ks
Maltese: X'inhu Keppra u għalxiex jintuża
English: The 300 ml glass bottle of Keppra (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.
Maltese: Il- flixkun tal-ħġieg ta' 300 ml ta' Keppra (għal tfal minn eta ta' erba' snin u ‘l fuq, addoloxxenti u adulti) huwa ppakkjat f'kaxxa tal-kartun li fiha siringa orali ta' 10 ml (b'marka tal-kejl kull 0.25 ml) u edepter għas-siringa.
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets 120 film-coated tablets
Maltese: 10 pillola miksija b'rita 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 60 pillola miksija b'rita 100 pillola miksija b'rita 100 x1 pillola miksija b'rita 120 pillola miksija b'rita
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website tal-Aġenzija Ewropea għall il-mediċini http://www.ema.europa.eu
English: Food and alcohol
Maltese: Alkoħol
English: It also contains maltitol liquid; patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Maltese: Fih ukoll maltitol likwidu; pazjenti bi problemi ereditarji rari ta' intoleranza għal fructose m'għandhomx jieħdu din il-mediċina.
English: Keppra 500 mg film-coated tablets
Maltese: Keppra 500 mg pilloli miksija b'rita
English: Aluminium/PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 filmcoated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' l-aluminju/PVC u mqegħda f' kaxxi tal-kartun ta' 10, 20, 30, 50, 60, 100, 120 pillola miksija b'rita u pakketti multipli li fihom 200 (2 pakketti ta' 100) pillola miksija b'rita.
English: • as an add-on to other antiepileptic medicines to treat: ▪ partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age ▪ myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy ▪ primary generalised tonic-clonic seizures(major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Maltese: • biex jiżdied ma' mediċini oħra ta' kontra l-epilessija fit-trattament (skossi qosra, bħal xokk f'muskolu jew grupp ta' muskoli) f' adulti u addoloxxenti minn 12 snin b'epilessija tat-tip mijoklonika li tibda fiż-żgħożija ▪ aċċessjonijiet tat-tip parzjali bi jew mingħajr ġeneralizzazzjoni f' adulti, addoloxxenti, tfal u trabi minn eta` ta' xahar.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Maltese: • raxx fil-ġilda, li jista' jifforma bżieżaq u li jidher qisu targi żgħar (tikek ċentrali skuri mdawwra b'erja iżjed pallida, b'ċirku skur mat-tarf) (erythema multiforme), raxx diffuz bil-bżieżaq u ġilda li titqaxxar, partikolarrment madwar il-ħalq, mnieħer, għajnejn u l-ġenitali (sindrome ta'
English: 7.5 ml twice daily
Maltese: 7.5 ml darbtejn kuljum
English: EU/1/00/146/028 200 tablets (2 packs of 100) EU/1/00/146/036 100 x 1 tablets
Maltese: EU/1/00/146/028 200 pillola (2 pakketti ta' 100)
English: 150 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 3 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Maltese: Dan issibu ġo kaxxa tal-kartun li fiha wkoll siringa orali ta' 3 ml mmarkata bil-kejl (polypropylene,polyethylene),u edepter għas-siringa (polyethylene).
English: • 1000 mg: 10, 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Maltese: 1000 mg: 10, 20, 30, 50, 60, 100 x 1, 100, pillola miksija b'rita u pakketti multipli li fihom 200 (2 paketti ta' 100) pilloli miksija b'rita.
English: 2.4 ml twice daily
Maltese: 4.6 Tqala u Treddigħ
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Maltese: Ebda reazzjonijet avversi fuq il-fertilita` maskili jew femminili jew abbilta` riproduttiva ma kienu osservati fil-firien f'dożi sa 1800 mg/kg/day (x 6 l-MRHD fuq bażi ta' mg/m2 jew t'esponiment) fil ġenituri u l-ġenerazzjoni F1.
English: • Wash the syringe with water only (figure 8).
Maltese: • Aħsel is-siringa bl-ilma biss (figura 8 )
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets
Maltese: 10 pillola miksija b'rita 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 60 pillola miksija b'rita 100 pillola miksija b'rita 100 pillola x1 miksija b'rita
English: EU/1/00/146/006 EU/1/00/146/007 EU/1/00/146/008 EU/1/00/146/009 EU/1/00/146/010 EU/1/00/146/011 EU/1/00/146/012 EU/1/00/146/013 EU/1/00/146/035
Maltese: EU/1/00/146/006 EU/1/00/146/007 EU/1/00/146/008 EU/1/00/146/009 EU/1/00/146/010
English: Children 25 kg or less should preferably start the treatment with Keppra 100 mg/ml oral solution.
Maltese: 1500 mg darbtejn kuljum (1) Tfal ta' 25 kg jew inqas għandhom preferabilment jibdew it-trattament b' Keppra 100 mg/ml soluzzjoni orali.
English: 100 film-coated tablets Component of a multipack, can't be sold separately.
Maltese: Part minn pakkett multiplu, ma jistax jinbiegħ separatament.
English: 2 ml twice daily
Maltese: 2 ml darbtejn kuljum
English: A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: (2)Doża kbira ta' 10.5 mg/kg (0.105 ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Maltese: • jekk inti allerġiku għal levetiracetam, derivattivi ta' pyrrolidone jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 80 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets
Maltese: 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 60 pillola miksija b'rita 100 pillola miksija b'rita 100 x 1 pillola miksija b'rita
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Maltese: Dan issibu ġo kaxxa tal-kartun li fiha wkoll siringa orali ta' 10 ml mmarkata bil-kejl (polypropylene,polyethylene),u edepter għas-siringa (polyethylene).
English: 150 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 1 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Maltese: Dan issibu ġo kaxxa tal-kartun li fiha wkoll siringa orali ta' 1 ml mmarkata bil-kejl (polypropylene,polyethylene),u edepter għas-siringa (polyethylene).
English: • sudden decrease in kidney function;
Maltese: • tnaqqis f'daqqa fil-funzjoni tal-kliewi
English: Add-on therapy for infants aged from 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Maltese: Dożaġġ fit-trabi ( 6 sa 23 xahar), tfal (2 sa 11 il-sena) u addoloxxenti (12 sa 17 il-sena) li jiżnu inqas minn 50 kg:
English: Aluminium/PVC blisters placed into cardboard boxes containing 20, 30, 50, 60, 80, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' l-aluminju/PVC u mqegħda f' kaxxi tal-kartun ta' 20, 30, 50, 60, 80, 100 pillola miksija b'rita u pakketti multipli li fihom 200 (2 pakketti ta' 100) pillola miksija b'rita.
English: Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Maltese: (2) Wara id-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 5 u 10 mg/kg (0.05 sa 0.10 ml/kg).
English: A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: (1) Doża kbira ta' 15 mg/kg (0.15 ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: Box of 20, 30, 50, 60, 80, 100, 100 (100 x 1)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA ta' 20, 30, 50, 60, 80, 100, 100 (100 x 1), 200 (2 x 100)
English: Each ml contains 100 mg levetiracetam
Maltese: Kull ml fih 100 mg levetiracetam.
English: Box of 10, 20, 30, 50, 60, 100, 100 (100 x 1)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA ta' 10, 20, 30, 50, 60, 100, 100 (100 x 1)
English: Aluminium/PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' l-aluminju/PVC u mqegħda f' kaxxi tal-kartun ta' 10, 20, 30, 50, 60, 100 pillola miksija b'rita u pakketti multipli li fihom 200 (2 pakketti ta' 100) pillolo miksija b'rita.
English: Keppra concentrate for solution for infusion is an alternative for patients when administration of the antiepileptic oral Keppra medicine is temporarily not feasible.
Maltese: Il-konċentrat Keppra huwa alternattiva għal pazjenti li temporanjament ma' jistgħux jieħdu mediċina mill-ħalq.
English: Keppra 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don't allow accurate dosage.
Maltese: Keppra 100 mg/ml soluzzjoni orali hija l-għamla l-iżjed adatta għal trabi u tfal taħt l-eta` ta' 6 snin u fit-tfal u adoloxxenti (minn 6 sa 17-il sena) li jiżnu inqas minn 50kg u meta bil-pilloli ma' jistax ikollok dożaġġ eżatt.
English: Keppra 100 mg/ml concentrate for solution for infusion Levetiracetam
Maltese: Keppra 100 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
Maltese: In- NOAEL kien ta' ≥ 1800 mg/kg/ġurnat għal firien feminili F0, u għassopravivenza, kobor u l-iżvillup taż=żrameġ F1 sa kemm jibdew jieklu weħedhom ( x6 il-MRHD fuq bażi ta' mg/m2).
English: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment.
Maltese: Stevens-Johnson), u forma iżjed severa li tikkawża ġilda li titqaxxar f'iżjed minn 30% tal-wiċċ tal-ġilda (nekroliżi tossiku epidermali).
English: • Keppra is used as a chronic treatment.
Maltese: • Keppra huwa wżat bħala trattament għal marda kronika.
English: Keppra is for intravenous use.
Maltese: Kienu wkoll identifikati żewġ prodotti tal-metaboliżmu inqas importanti.
English: Instructions for use: • Open the bottle: press the cap and turn it anticlockwise (figure 1)
Maltese: • Iftaħ il-flixkun: agħfas l-għatu u dawru kontra l-arloġġ (figura 1 )
English: EU/1/17/1238/001 Nyxoid
Maltese: EU/1/17/1238/001
English: 2 spray containers
Maltese: 2 Botts sprej
English: 1.8 mg Nasal spray, solution Nasal use vial (glass)
Maltese: 1.8 mg Sprej għallimnieħer,
English: London, June 2008 EMEA/532160/2007 - Rev.1
Maltese: Londra, Ġunju 2008 EMEA/532160/2007 - Rev.1
English: EMEA/532160/2007-Rev.1
Maltese: EMEA/532160/2007-Rev.1-MT
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR DOLOVET
Maltese: OPINJONI WARA REFERENZA SKOND L-ARTIKOLU 33 (4) GĦAL DOLOVET
English: The experimental design of the study mimicked acute toxic mastitis.
Maltese: Id-disinn sperimentali ta' l-istudju imita mastite tossika akuta.
English: The CVMP Opinion was adopted on 9 November 2006 and the subsequent Commission Decision on 17 April 2007.
Maltese: L-Opinjoni tas-CVMP ġiet adottata fid-9 ta' Novembru 2006 u d-Deċiżjoni suċċessiva talKummissjoni ġiet adottata fis-17 ta' April 2007.
English: The CVMP during its meeting of 14-16 March 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended.
Maltese: Waqt il-laqgħa tiegħu ta' l-14-16 ta' Marzu 2006, il-CVMP beda proċedura ta' referenza skond lArtikolu 33(4) tad-Direttiva 2001/82/KE, kif emendat.
English: Dolovet vet 2.4g oral powder is a powder presented in sachets of 15g, each containing 2.4g ketoprofen and is authorised for the treatment of fever and inflammation in cattle.
Maltese: Dolovet vet 2.4g trab orali huwa trab ippreżentat fi qratas ta' 15g, kull wieħed fih 2.4g ketoprofen u huwa awtorizzat għat-trattament tad-deni u l-infjammazzjoni fl-ifrat.
English: A Mutual Recognition Procedure (MRP) started on 22 September 2005 with Finland acting as Reference Member State and twelve Concerned Member States.
Maltese: Fit-22 ta' Settembru 2005 bdiet proċedura ta' Rikonoxximent Reċiproku (MRP) mal-Finlandja bħala Stat Membru ta' Referenza u tnax-il Stat Membru Konċernat.
English: Even though equivalence has not been formally shown, the two products perform similarly when compared to placebo in regards to a number of critical parameters, both clinical and otherwise (thromboxane B2 levels in plasma).
Maltese: Minkejja li l-ekwivalenza ma ntwerietx b'mod formali, iż-żewġ prodotti jaħdmu b'mod simili meta mqabbla mal-plaċebo fir-rigward ta' numru ta' parametri kritiċi, it-tnejn kliniċi jew mod ieħor (livelli ta' thromboxane B2 fil-plażma).
English: The statistical report indicated that the number of animals used did not allow equivalence to be established (nor non-inferiority) between Dolovet containing ketoprofen administered orally at the dose of 4 mg/kg bodyweight and Ketofen containing ketoprofen administered intramuscularly at the dose of 3 mg/kg.
Maltese: Ir-rapport statistiku indika li n-numru ta' annimali li ntużaw ma ppermettiex li tiġi stabbilita l-ekwivalenza (u lanqas in-non-inferjorità) bejn Dolovet li fih ketoprofen mogħti b'mod orali fid-doża ta' 4 mg/kg ta' piż tal-ġisem u Ketofen li fih ketoprofen mogħti ġol-muskoli fid-doża ta' 3 mg/kg.
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use (CVMP).
Maltese: Il-kwistjoni ġiet riferuta lill-Grupp ta' Koordinament għall-Proċeduri ta' Rikonoxximent Reċiproku u Deċentralizzati, CMD(v), u suċċessivament lill-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP).
English: Belgium and Norway could not agree with granting a marketing authorisation.
Maltese: Il-Belġju u n-Norveġja ma setgħux jaqblu ma' l-għoti ta' l-awtorizzazzjoni għat-tqegħid fis-suq.
English: However, given that the pharmacokinetic data allowed the optimisation of the dose (keeping overall exposure comparable between the two products), it was concluded that a bridge existed allowing well established use to apply to Dolovet.
Maltese: Madankollu, minħabba li d-dejta farmakokinetika ppermettiet l-ottimizzazzjoni tad-doża (li żżomm lesponiment globali komparabbli bejn iż-żewġ prodotti), ġie konkluż li kien jeżisti pont li jippermetti li użu stabbilit sewwa jiġi applikat għal Dolovet.
English: Considering the data provided and the well-established use of ketoprofen, the CVMP was of the opinion that the claim “Alleviation of inflammation and reduction of fever in individual animals” had been substantiated.
Maltese: Wara li kkunsidra d-dejta pprovduta u l-użu stabbilit sewwa ta' ketoprofen, is-CVMP kien ta' lopinjoni li l-affermazzjoni “It-taffija ta' l-infjammazzjoni u t-tnaqqis tad-deni f'annimali individwali” kienet ġiet issostanzjata.
English: Belgium and Norway considered that this medicinal product could present a potential serious risk to animal health on the grounds that the efficacy had not been sufficiently substantiated in the dossier.
Maltese: Il-Belġju u n-Norveġja ħassew li dan il-prodott mediċinali jista' jippreżenta riskju potenzjali serju għas-saħħa ta' l-annimali minħabba li l-effikaċja tiegħu ma kinetx ġiet issostanzjata b'mod suffiċjenti fir-rapport.
English: 61700 Brno Czech Republic
Maltese: 61700 Brno
English: Cellulose, microcrystalline (E460) Crospovidone type A Castor oil, hydrogenated
Maltese: Cellulose, microcrystalline (E460) Crospovidone type A Castor oil, idroġenat
English: Date of latest renewal: 22 May 2014
Maltese: Data tal-aħħar tiġdid: 22 ta' Mejju, 2014
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Maltese: Clopidogrel u l-metabolit prinċipali (inattiv) ċirkolanti jintrabtu b'mod reversibbli in vitro malproteini umani tal-plażma (98% u 94% rispettivament).
English: New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Maltese: 22 % (CI: 8.6, 33.4), 32 % (CI: 12.8, 46.4), 4 % (CI: -26.9, 26.7), 6 % (CI: -33.5, 34.3) u 14 % (CI: -31.6, 44.2), waqt l-intervalli ta' studju ta' 0 - 1, 1 - 3, 3 - 6, 6 - 9 u 9 - 12 xhur, rispettivament.
English: Contains hydrogenated castor oil.
Maltese: TA' EĊĊIPJENTI Fih castor oil idroġenat.
English: Alu/Alu blisters containing 7, 14, 28, 30, 50, 84, 90 and 100 film-coated tablets packed in cardboard cartons.
Maltese: Folji Alu/Alu li fihom 7, 14, 28, 30, 50, 84, 90 u 100 pillola miksija b'rita, ippakkjati f'kaxxi talkartun.
English: Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Maltese: Prodotti mediċinali li huma inibituri qawwijin jew moderati ta' CYP2C19 jinkludu, per eżempju omeprazole u esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine u efavirenz.