FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of a marketing authorisations provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc, are added to the product information.
Maltese: Is-CVMP ikkonkluda li t-tħassib muri minn Franza u n-Netherlands ma għandux iwaqqaf l-għoti ta' awtorizzazzjonijiet għat-tqegħid fis-suq, diment li l-miżuri ta' mitigazzjoni tar-riskji rrakkomandati, li huma mbassra li jnaqqsu l-akkumulazzjoni taż-żingu, jiżdiedu mal-informazzjoni tal-prodott.
English: Due to the intrinsic nature of zinc (non-volatile and non-degradable) the potential for PNECs to be eventually surpassed as a result of continual application of manure from treated animals to land over an extended period is a significant environmental concern, particularly with regard to the most vulnerable soil types (acidic, freely draining, sandy soils) and organisms of the aquatic compartments.
Maltese: Minħabba n-natura intrinsika taż-żingu (mhux volatili u mhux degradabbli), il-potenzjal għall-PNEC li eventwalment jinqabżu bħala riżultat ta' applikazzjoni kontinwa ta' demel minn annimali kkurati lill-art għal perjodu estiż, huwa ta' tħassib ambjentali sinifikanti, b'mod partikolari fir-rigward tat-tipi ta' ħamrija l-aktar vulnerabbli (ħamrija aċiduża, li minnha l-ilma jiskula b'mod liberu, ramlija) u organiżmi tal-kompartimenti akwatiċi.
English: Concerning sediment PECs particularly, accumulation factors are not considered (e.g. deposition, re-suspension, and burial of zinc), it is assumed that suspended sediments are representative of the deposited sediment, and no account is made for acid volatile sulfide levels.
Maltese: Fir-rigward, b'mod partikolari tal-PECs tas-sediment, il-fatturi ta' akkumulazzjoni mhumiex ikkunsidrati (eż. iddepożizzjoni, is-sospensjoni mill-ġdid, u t-tirdim ta' żingu), huwa preżunt li sedimenti sospiżi huma rappreżentattivi tas-sediment depożitat, u ma jiġux ikkunsidrati l-livelli ta' sulfidi volatili tal-aċidu.
English: • However, it is deemed appropriate that having addressed the environmental concerns of the use of Gutal and having identified an environmental risk from the use of zinc containing veterinary medicinal products, that further risk management measures are taken to reduce the accumulation of zinc in soil, water and sediment compartments.
Maltese: • Madankollu, jitqies xieraq li, peress li t-tħassib ambjentali tal-użu ta' Gutal ġie indirizzat u peress li ġie identifikat riskju ambjentali mill-użu ta' prodotti mediċinali veterinarji li fihom iż-żingu, jittieħdu miżuri oħrajn ta' ġestjoni tar-riskju biex titnaqqas l-akkumulazzjoni ta' żingu fil-kompartimenti talħamrija, l-ilma u s-sediment.
English: Although this RMM would most likely reduce the risk for all compartments, a risk for surface water and, particularly, sediment may remain.
Maltese: Għalkemm din l-RMM, probabbilment tnaqqas ir-riskju għall-kompartimenti kollha, jaf jibqa' jkun hemm riskju għall-ilma talwiċċ u, b'mod partikolari, is-sediment.
English: Belgium Huvepharma NV Uitbreidingstraat 80
Maltese: Il-Polonja Huvepharma NV Uitbreidingstraat 80
English: Romania Huvepharma NV Uitbreidingstraat 80
Maltese: Ir-Romanija Huvepharma NV Uitbreidingstraat 80
English: However, in contrast to the CVMP/VICH approach, the IDMM predicts the fate and behaviour of zinc in soil, differentiates sites on zinc sensitivity, accommodates aged zinc, considers environmental sources of potential toxicants, and accommodates for ambient levels of naturally occurring substances.
Maltese: Madankollu, b'kuntrast għall-approċċ CVMP/VICH, l-IDMM ibassar id-destin u l-imġiba taż-żingu filħamrija, jagħmel distinzjoni fis-siti skont is-sensittività għaż-żingu, jakkomoda ż-żingu li għandu żżmien, jikkunsidra s-sorsi ambjentali ta' tossikanti potenzjali, u jakkomoda livelli ambjentali ta' sustanzi li jinstabu fin-natura.
English: Hungary Huvepharma NV Uitbreidingstraat 80
Maltese: L-Ungerija Huvepharma NV Uitbreidingstraat 80
English: *Relative Potency Units (ELISA)
Maltese: *Unitajiet tal-Potenza Relattiva (ELISA)
English: LTA from BAC of Streptococcus uberis, strain 5616 Relative Potency ≥ 1 RPU
Maltese: LTA mill-BAC ta' Streptococcus uberis, razza 5616 Qawwa Relattiva ≥ 1 RPU
English: Subunit vaccine to stimulate active immunity against Streptococcus uberis.
Maltese: Sottunità ta' vaċċin li jistimula l-immunità attiva kontra Streptococcus uberis.
English: Carretera C63 Km 48, 300, Poligono Industrial El Rieral 17170 Amer (Girona) Spain
Maltese: Carretera C63 Km 48,300, Polígono Industrial El Rieral 17170 Amer (Girona) Spanja
English: ATCvet code: QI02AB .
Maltese: Kodiċi ATC veterinarja QI02AB.
English: Polyethylene (PET) vials of 10, 50 and 100 ml.
Maltese: Kunjetti tal-polyethylene (PET) ta' 10, 50 u 100 ml.
English: Monophosphoryl Lipid A (MPLA) Disodium phosphate dodecahydrate Potassium dihydrogen phosphate
Maltese: Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Sodium chloride
English: 5 doses (1 vial of 10 ml)
Maltese: 5 doża (10 ml)
English: In a multicentre field study, the incidence of new cases of Streptococcus uberis clinical intramammary infection in the group vaccinated with UBAC was 50% lower than the incidence in the placebo group (6.1% versus 12.2%) which was statistically significantly different (p=0.012).
Maltese: Fi studju multi-ċentriku fuq il-post, l-inċidenza ta' każijiet ġodda ta' infezzjoni intramammarja klinika minn Streptococcus uberis fil-grupp imlaqqam minn UBAC, kien 50% inqas mill-inċidenza tal-grupp plaċebo (6.1% kontra 12.2%) li kien statistikament differenti b'mod sinifikattiv (p=0.012).
English: One dose (2 ml) contains: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain
Maltese: Lipoteichoic acid (LTA) minn Komponent ta' Adeżjoni Biofilm (BAC) ta' Streptococcus uberis,
English: 25 doses (1 vial of 50 ml) 50 doses (1 vial of 100 ml) 25 doses (50 ml) 50 doses (100 ml)
Maltese: 20 x 1 doża (kunjett 1 ta' 2 ml) 5 doża (kunjett 1 ta' 10 ml) 25 doża (kunjett 1 ta' 50 ml) 50 doża (kunjett 1 ta' 100 ml) 25 doża (50 ml) 50 doża (100 ml)
English: Overdose (symptoms, emergency procedures, antidotes): No information is available.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti):
English: Onset of immunity: approximately 36 days after the second dose.
Maltese: Bidu tal-immunità: madwar 36 jum wara t-tieni doża.
English: Bearing in mind that some cows had suffered more than one episode of Streptococcus uberis clinical intramammary infection, the incidence of cows with clinical intramammary infection was 52.5% lower in the vaccinated group than those of the placebo group (4.7% versus 9.9%), with a statistical significance of p<0.017.
Maltese: Inżommu f'moħħna li bosta baqar kellhom iktar minn episodju wieħed ta' infezzjoni klinika intramammarja ta' Streptococcus uberis, l-inċidenza ta' baqar b'infezzjoni klinika intramammarja kienet 52.5% inqas fillgrupp imlaqqam minn dawk tal-grupp plaċebo (4.7% kontra 9.9%) b'sinifikat statistiku ta' p<0.
English: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 .................................................................................................................................. ≥ 1 RPU*
Maltese: razza 5616 .................................................................................................................. ≥ 1 RPU*
English: <{MM/YYYY}>
Maltese: U/JEW UŻU
English: Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Maltese: Immunoloġiċi għall-bovidae, vaċċini batteriċi inattivati għall-baqar.
English: White homogeneous emulsion.
Maltese: Emulsjoni omoġenja bajda.
English: - 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)
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieq(a) 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).
English: Cardboard box with 1 PET vial of 5, 25 and 50 doses.
Maltese: Kaxxa tal-kartun b'1 kunjett tal-PET ta' 5, 25 u 50 doża.
English: Allow the vaccine to reach a temperature of +15 to + 25 °C before administration.
Maltese: Ħalli l-vaċċin jilħaq temperatura ta' bejn +15 u +25°C) qabel tagħtih.
English: Vial of 25 and 50 doses.
Maltese: Kunjett ta' 25 u 50 doża.
English: Immunisation has to be considered as one component in a complex mastitis intramammary infection control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality and health monitoring) and other management practices.
Maltese: L-immunizzazzjoni għandha tiġi kkunsidrata bħala komponent wieħed fi programm ta' kontroll talinfezzjoni intramammarja kumpless li jindirizza l-fatturi importanti kollha tas-saħħa tal-bżieżel (eż. it teknika ta' ħlib, it-tnixxif u l-ġestjoni tat-tgħammir, l-iġjene, in-nutrizzjoni, l-akkomodazzjoni, il-postfejn jorqdu, il-kumdità tal-baqar, il-kwalità tal-arja u tal-ilma u l-monitoraġġ tas-saħħa) u prattiċi ta' ġestjoni oħra.
English: LABORATORIOS HIPRA, S.A. Avda.
Maltese: Laboratorios Hipra, S.A.
English: HIPRA DEUTSCHLAND GmbH
Maltese: HIPRA BENELUX NV
English: Cardboard box with 20 glass vials of 1 dose (2 ml).
Maltese: Kaxxa tal-kartun b'20 kunjett tal-ħġieġ ta' 1 doża (2 ml).
English: Local swelling more than 5 cm in diameter at the injection site is a very common reaction after administration of the vaccine.
Maltese: Nefħa lokali ta' dijametu ta' aktar minn 5 cm fil-post tal-injezzjoni hija reazzjoni komuni ħafna wara lgħoti tal-vaċċin.
English: UBAC emulsion for injection for cattle
Maltese: VETERINARJU UBAC emulsjoni għall-injezzjoni għall-baqar
English: Vial label 1 dose and 5 doses
Maltese: Tikketta tal-kunjett ta' doża 1 u 5 dożi
English: This swelling will have disappeared or be clearly reduced in size by 17 days post vaccination.
Maltese: Din in-nefħa tisparixxi jew tkun viżibbilment iżgħar 17-il jum wara t-tilqim.
English: Store and transport refrigerated (2 ºC - 8 °C) and protected from light.
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C) u pproteġi mid-dawl.
English: Cardboard box with 1 PET vial of 25 doses (50 ml).
Maltese: Kaxxa tal-kartun b'1 kunjett tal-PET ta' 25 doża (50 ml).
English: Cardboard box with 1 PET vial of 5 doses (10 ml).
Maltese: Kaxxa tal-kartun b'1 kunjett tal-PET ta' 5 dożi (10 ml).
English: UBAC emulsion for injection for cattle.
Maltese: VETERINARJU Emulsjoni UBAC għall-injezzjoni għall-baqar.
English: Cardboard box with 1 PET vial of 50 doses (100 ml).
Maltese: Kaxxa tal-kartun b'1 kunjett tal-PET ta' 50 doża (100 ml).
English: Name and address of the manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Maltese: Isem u indirizz tal-manufattur tas-sustanza bijoloġika attiva Laboratorios Hipra, S.A.
English: The full immunisation program should be repeated with each gestation.
Maltese: Il-programm ta' immunizzazzjoni sħiħ għandu jiġi ripetut ma' kull ġestazzjoni.
English: Date of first authorisation: <{DD/MM/YYYY}>
Maltese: DATA TA' REVIŻJONI TAT-TEST {XX/SSSS}
English: Administer one dose (2 ml) by deep intramuscular injection in the neck muscles according to the following immunisation program:
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni:
English: If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Maltese: Staqsi lill-kirurgu veterinarju lill-ispiżjar tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: HIPRA UK AND IRELAND, Ltd. Tel: (+44) 0115 912 4320
Maltese: HIPRA DEUTSCHLAND GmbH Tel: (+49) 211 698236 - 0
English: Batch {number}
Maltese: PERJODU TA' TIŻMIM
English: MANUFACTURER'S BATCH NUMBER
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott{numru}
English: Type I colourless glass vials of 3 ml.
Maltese: Ilma għall-injezzjonijiet
English: Applicant company name, address
Maltese: Stat Membru Applikant Isem talkumpanija, indirizz
English: DICLOFENAC EPOLAMINE ALTERGON 50MG TABLETS
Maltese: ALTERGON 50MG TABLETS
English: United Kingdom ALTERGON ITALIA S.r.L Via dell'Industria
Maltese: mod ta' amministrazzjoni u applikanti fl-Istati Membri
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants in the member states
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali,
English: Strength Pharmaceutical form
Maltese: MG TABLETY
English: The total daily dose was administered twice daily.
Maltese: The total daily dose was administered darbtejn kuljum.
English: UCB logo.
Maltese: FIS-SUQ UCB logo
English: A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six months and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 months to less than 4 years old, was use in this study.
Maltese: A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six month and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 month to less than 4 years old, was use in this study.
English: I-10044 Pianezza
Maltese: I-10044
English: Contains E216, E218 and maltitol liquid.
Maltese: TA' EĊĊIPJENTI Fih E216, E218 u maltitol likwidu.
English: NextPharma SAS, 17 Route de Meulan, F-78520 Limay, France.
Maltese: NextPharma SAS 17, Route de Meulan F-78520 Limay Franza
English: Date of first authorisation: 29 September 2000 Date of latest renewal: 20 August 2015
Maltese: Data tal-aħħar tiġdid: 20 Awissu 2015
English: Aesica Pharmaceuticals S.r.l.
Maltese: jew Aesica Pharmaceuticals S.r.l.
English: UCB Pharma Romania S.R.L.
Maltese: UCB Pharma România S.R.L.
English: Toxic epidermal necrolysis, StevensJohnson syndrome, erythema multiforme
Maltese: Nekroliżi epidermali tossiku, sindromu ta' StevensJohnson, eritema multiforme
English: The other ingredients are: Tablet core: croscarmellose sodium, macrogol 6000, silica colloidal anhydrous, magnesium stearate.
Maltese: Il-qalba: croscarmellose sodium, macrogol 6000, silica colloidal anhydrous, magnesium stearate.
English: Contains sunset yellow (E 110).
Maltese: TA' EĊĊIPJENTI Fih sunset yellow (E 110).
English: Abnormal and aggressive behaviours
Maltese: Imġiba anormali u aggressiva
English: Keppra 750 mg tablets contain Sunset Yellow FCF (E110).
Maltese: Keppra 750 mg pilloli fihom Sunset Yellow FCF (E110).
English: Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza, Italy
Maltese: Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044
English: Aesica Pharmaceuticals S.r.l., Via Praglia, 15, I-10044 Pianezza, Italy.
Maltese: Aesica Pharmaceuticals S.r.l., Via Praglia, 15, I-10044
English: 500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily
Maltese: 500 sa 1,500 mg darbtejn kuljum 500 sa 1,000 mg darbtejn kuljum 250 sa 750 mg darbtejn kuljum 250 sa 500 mg darbtejn kuljum 500 to 1,000 mg darba kuljum (2)
English: 250 mg tablet: indigo carmine aluminium lake (E132) 500 mg tablet: iron oxide yellow (E172) 750 mg tablet: sunset yellow FCF (E110), iron oxide red (E172)
Maltese: *Is-sustanzi li jagħtu l-kulur huma: pllola 250 mg: indigo carmine aluminium lake (E132) pillola 500 mg: iron oxide yellow (E172) pillola 750 mg: sunset yellow FCF (E110), iron oxide red (E172)
English: CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m
Maltese: CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73 BSA pazjent (m2)
English: The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour, purified water.
Maltese: Sustanzi oħra jinkludu: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol likwidu (E965), acesulfame potassium (E950), grape flavour, ilma purifikat.
English: B-1420 Braine-l'Alleud
Maltese: Braine-l'Alleud
English: Keppra contains sodium
Maltese: Keppra fih sodium
English: Levetiracetam may cause psychotic symptoms and behavioural abnormalities including irritability and aggressiveness.
Maltese: Levetiracetam jista' jikkawża sintomi psikotiċi u anormalitajiet fl-imġiba, inkluż irritabilità u aggressività.
English: • Sodium chloride 9 mg/ml (0.9%) solution for injection
Maltese: • soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%)
English: Maltitol liquid (E965) Acesulfame potassium (E950) Grape flavour
Maltese: Acesulfame potassium (E950)
English: UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium.
Maltese: SA, Allée de la Recherche 60, B-1070 Brussell, Belġju.
English: Six-month seizure freedom was achieved in 73.0 % of levetiracetam-treated patients and 72.8 % of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2 % (95 % CI: -7.8 8.2).
Maltese: Kien hemm 73.0 % tal-pazjenti li ġew trattati b' levetiracetam u 72.8 % ta' pazjenti li ġew trattati b' carbamazepine-CR li damu sitt xhur mingħajr aċċessjonijiet; id-differenza assoluta aġġustata bejn ittrattamenti kienet ta' 0.2 %(95 % CI:-7.8 8.2).
English: Sunset yellow FCF aluminium lake (E110) Iron oxide red (E172)
Maltese: Sunset yellow FCF aluminium lake (E110)
English: Croscarmellose sodium Macrogol 6000
Maltese: Macrogol 6000
English: Keppra 250 mg film-coated tablets Keppra 500 mg film-coated tablets Keppra 750 mg film-coated tablets Keppra 1000 mg film-coated tablets
Maltese: Keppra 250 mg pilloli miksija b'rita Keppra 500 mg pilloli miksija b'rita Keppra 750 mg pilloli miksija b'rita Keppra 1000 mg pilloli miksija b'rita
English: One vial of Keppra concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
Maltese: Vjala waħda ta' Keppra fiha 500 mg ta' levetiracetam (5 ml ta' konċentrat ta' 100 mg/ml ).
English: Bottle of 300 ml
Maltese: Flixkun ta' 300 ml
English: 28 mg (0.3 ml) twice daily 84 mg (0.85 ml) twice daily
Maltese: 28 mg (0.3 ml) darbtejn kuljum 84 mg (0.85 ml) darbtejn kuljum
English: Film-coating: Polyvinyl alcohol-part. hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, colourants*.
Maltese: Il-kisja tar-rita: (Polyvinyl alcohol-part.hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, sustanza li jagħtu l-kulur*.
English: [140-age( years)] x weight (kg)
Maltese: [140 -eta` (snin)] x piż (kg)
English: 60 mg (0.6 ml) twice daily 180 mg (1.8 ml) twice daily
Maltese: 60 mg (0.6 ml) darbtejn kuljum 180 mg (1.8 ml) darbtejn kuljum
English: Keppra 100 mg/ml oral solution
Maltese: Keppra 100 mg/ml soluzzjoni orali
English: Keppra oral solution also contains maltitol.
Maltese: Keppra soluzzjoni orali fiha wkoll maltitol.
English: Polyvinyl alcohol-part.hydrolyzed Titanium dioxide (E171) Macrogol 3350
Maltese: Polyvinyl alcohol-part.hydrolyzed Titanium dioxide (E171)
English: 200 mg (2 ml) twice daily 600 mg (6 ml) twice daily
Maltese: 200 mg (2 ml) darbtejn kuljum 600 mg (6 ml) darbtejn kuljum25 kg
English: • Dextrose 50 mg/ml (5%) solution for injection
Maltese: • soluzzjoni għall-injezzjoni ta' Dextrose 50 mg/ml (5%)
English: Each ml contains 2.7 mg of methyl parahydroxybenzoate (E218), 0.3 mg of propyl parahydroxybenzoate (E216) and 300 mg of maltitol liquid.
Maltese: Kull ml fih 2.7 mg ta' methyl parahydroxybenzoate (E218), 0.3 mg ta' propyl parahydroxybenzoate (E216) u 300 mg ta' maltitol likwidu.
English: Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.
Maltese: Sunset Yellow FCF (E110) sustanza li tgħati l-kulur tista' tikkawża reazzjonijiet allerġiċi.
English: Pancytopenia, neutropenia, agranulocytosis
Maltese: Pansitopenja , newtropenja, agranuloċitożi
English: 49 mg (0.5 ml)twice daily 147 mg (1.5 ml) twice daily
Maltese: 49 mg (0.5 ml) darbtejn kuljum 147 mg (1.5 ml) darbtejn kuljum
English: ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Maltese: ks= 0.55 f' Tfal sa inqas minn 13-il sena u f'addoloxxenti feminili; ks= 0.7 f' addoloxenti maskili
English: Bottle of 150 ml
Maltese: Flixkun ta' 150 ml
English: Sodium acetate Glacial acetic acid Sodium chloride Water for injections
Maltese: Sustanzi oħra jinkludu: sodium acetate, glacial acetic acid, sodium chloride, ilma għall-injezzjoni
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Maltese: [140 -eta` (snin)] x piż (kg) Clcr (ml/min)= --------------------------------------------------- (x 0.85 għan-nisa) 72 x livell ta' krejatinina fis-serum (mg/dl)
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Maltese: Ir-reazzjonijiet avversi kienu ppreżentati f'ordni ta' gravita` minn ħafna għal ftit u il-frekwenza giet mfissra b'dan il-mod: komuni hafna (≥1/10); komuni: (>1/100 sa 1/10); mhux komuni: (>1/1,000 sa 1/100) u rari: (≥1/10,000 sa 1/1,000); rari ħafna: (≤1/10,000)
English: It was concluded that Keppra was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Maltese: Kien konkluż li Keppra ma kienx differenti (mhux inferjuri) mill-plaċebo fejn jidħol il-bidla mill-linja bażi tal- Leiter-R Attention and Memory, Memory Screen Composite score fil-popolazzjoni skond il-protokol.
English: 35 mg (0.35 ml) twice daily 105 mg (1.05 ml) twice daily
Maltese: 35 mg (0.35 ml) darbtejn kuljum 105 mg (1.05 ml) darbtejn kuljum
English: One tablet of Keppra 1,000 mg contains 1,000 mg of levetiracetam.
Maltese: Pillola waħda ta' Keppra 1,000 mg fih 1,000 mg levetiracetam.
English: 100 mg (1 ml) twice daily 300 mg (3 ml) twice daily
Maltese: 100 mg (1 ml) darbtejn kuljum 300 mg (3 ml) darbtejn kuljum
English: EU/1/00/146/006 10 tablets EU/1/00/146/007 20 tablets EU/1/00/146/008 30 tablets EU/1/00/146/009 50 tablets EU/1/00/146/010 60 tablets EU/1/00/146/011 100 tablets EU/1/00/146/012 120 tablets EU/1/00/146/013 200 tablets (2 packs of 100) EU/1/00/146/035 100 x 1 tablets
Maltese: EU/1/00/146/006 10 pillola EU/1/00/146/007 20 pillola EU/1/00/146/008 30 pillola EU/1/00/146/009 50 pillola EU/1/00/146/010 60 pillola EU/1/00/146/011 100 pillola EU/1/00/146/012 120 pillola EU/1/00/146/013 200 pillola (2 pakketti ta' 100)
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Maltese: Reazzjoni għallmediċina b'esinofilja u sintomi sistemiċi (DRESS), Ipersensitivita` (inkluż anġjoedima u anafillassi)
English: Orange, 18 mm oblong, scored and debossed with the code “ucb” and “750” on one side.
Maltese: Oranġjo, 18 mm tawwalija, maqtuha minn nofs u mnaqqxa bil-kodiċi “ucb” u ”750” fuq naħa waħda.
English: One tablet of Keppra 750 mg contains 750 mg of levetiracetam.
Maltese: Pillola waħda ta' Keppra 750 mg fih 750 mg levetiracetam.
English: The metabolite ucb L057 is pharmacologically inactive.
Maltese: ucb L057 mhuwiex attiv farmakoloġikament.
English: Remove the syringe from the adaptor (figure 6B).
Maltese: Neħħi s-siringa mill-edepter (figura 6B).