FrancophonIA/ELRC3.0 huggingface dataset:
English: These antigens can be considered as “novel” antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Maltese: Dawn l-antiġeni jistgħu jitqiesu bħala antiġeni “novelli” u jissimulaw sitwazzjoni fejn il-popolazzjoni fil-mira għal vaċċinazzjoni tkun immunoloġikament inġenwa.
English: Interpandemic trivalent vaccines
Maltese: Disturbi fis-sistema immuni
English: • Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘GuillainBarré Syndrome'.
Maltese: (enkefalomjelite), infjammazzjoni tan-nervituri (nevrite) jew tip ta' paraliżi magħrufa bħala
English: There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Maltese: Ma hemm l-ebda data fuq amministrazzjoni ta' vaċċini stimulati b'AS03 qabel jew wara tipi ta' vaċċini ta' l-influwenza oħra intiżi għall-użu qabel jew waqt pandemija.
English: In a clinical study (D-Pan-H5N1-009), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Maltese: Fi studju kliniku (D-Pan-H5N1-009), tfal ta' bejn it-3 u l-5 snin u s-6 u d-9 snin irċivew żewġ dożi jew ta' doża sħiħa (0.5 ml) jew ta' nofs doża (0.25 ml) ta' tilqima stimulatb'AS03 li kien fiha 3.75 µg ta'
English: The following age groups will be used: < 2 years, 2-8 years, > 9 years.
Maltese: Se jintużaw dawn il-gruppi ta' eta' li ġejjin: < 2 snin, 2-8 snin, ≥9
English: Uncommon: paraesthesia, somnolence, dizziness
Maltese: • Dijarea, rimettar, uġigħ fl-istonku, dardir
English: Adults aged 18-60 years
Maltese: Adulti mill-età ta' 18 -il sena:
English: All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Maltese: L-eventi kollha mhux konfermati medicament huma dawk li iddaħħlu fid-database sad-‘datalock point'.
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Maltese: Tel:+ 39 (0)45 9218 111
English: 24 months after the 1st dose
Maltese: 24 xahar wara t-tilqima
English: Uncommon: pruritus, rash
Maltese: Mhux komuni: telqa
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate against A/Vietnam/1194/2004 in subjects who received the vaccine 6 months apart were 89.6% and 95.7%, respectively.
Maltese: Wieħed u għoxrin jum wara t-tieni doża, ir-rata ta' seroprotezzjoni u r-rata ta' rispons tal-vaċċin kontra A/Vietnam/1194/2004 f'indivdwi li rċevew il-vaċċin 6 xhur il-bogħod minn xulxin kienu 89.6% u 95.7%, rispettivament.
English: The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni.
English: All tables will be based on generic and not product-specific data1.
Maltese: It-tabelli kollha ser ikunu ibbażati fuq dejta ġenerika u mhux speċifika għall-prodott1.
English: Tell the doctor requesting these tests that you have recently received Adjupanrix.
Maltese: L-ebda każ ta' doża eċċessiva ma ġie rrappurtat.
English: However, following two administrations of a double dose of vaccine, the seroprotection rate at day 42 was 75%.
Maltese: Madankollu, wara żewġ amministrazzjonijiet ta' doża doppja ta' vaċċin, ir-rata ta' seroprotezzjoni f'ġurnata 42 kienet ta' 75%.
English: Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Maltese: Eventi avversi serji kollha (SOC, HLT, PTs) li seħħew f'nisa tqal, stratifikati skond it-tip ta' rapport (konfermat medicament jew mhux konfermat medicament), għal perjodu kopert mir rapport u kumultivament.
English: 21 days after 1st dose
Maltese: 21 jum wara t-tieni doża
English: • Inflammation of your blood vessels (vasculitis).
Maltese: • Infjammazzjoni tal-kanali tad-demm (vaskulite).
English: The frequency of side effects was lower in the group of children who received half of the adult dose.
Maltese: Il-frekwenza tal-effetti sekondarji kienet anqas fil-grupp ta' tfal li rċivew nofs id-doża tal-adulti.
English: Pandemic preparedness vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Maltese: Preparazzjoni pandemika u kull dejta dwar sigurta' rilevanti għal dik is-sistema ta' suppliment.
English: Medicinal product subject to medical prescription.
Maltese: SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Maltese: Respons immuni ta' protezzjoni jista' ma jirriżultax f'kull minn jieħu l-vaċċin (ara sezzjoni 5.1).
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004
Maltese: vaċċin stimulat b'AS03 li kien fih 3.75 µg HA derivata minn A/Indonesia/5/2005 36 xahar wara li kienu rċevew żewġ dożi ta' A/Vietnam/1194/2004.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Maltese: U KONTENUT Antiġen suspensjoni tal-antiġen għall-injezzjoni
English: To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
Maltese: Biex ir-rapport ta' sigurta' jitpoġġa f'kuntest, għandu jkun inkluż sommarju ta' distribuzzjoni talvaċċin u għandu jipprovdi dettalji tan-numru ta' dożi tal-vaċċin distribwiti fi i) Stati membri ta' l-UE għall-perjodu ta' rapurtaġġ skond in-numru tal-lott, ii) L-Istati membri ta' l-UE kumultivament u iii) Il-kumplament tad-dinja.
English: Anti-HA responses against A/Indonesia/5/2005 following administration of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were as follows:
Maltese: Responsi anti-HA kontra A/Indonesia/5/2005 wara t-teħid ta' vaċċin stimulat b'AS03 li fih 3.75μg HA
English: Adjupanrix
Maltese: Il-Belġju
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Maltese: Skond u wara l-implimentazzjoni tal-vaċċin meta sseħħ l-ewwel pandemiku u jibgħat din l-informazzjoni lis-CHMP għal evalwazzjoni.
English: Rare: Neuralgia, transient thrombocytopenia.
Maltese: Nevralġija, tromboċitopenija li tgħaddi.
English: Immune response to A/Indonesia/5/2005 6 to 9 years
Maltese: HA kontra A/Indonesia/5/2005 fil-jum
English: Milton Keynes, MK7 7AJ UK
Maltese: Milton Keynes, MK7 7AJ
English: EU/2/17/218/001 EU/2/17/218/002
Maltese: EU/2/17/218/001 EU/2/17/218/002 EU/2/17/218/003
English: Avoid introduction of contamination.
Maltese: Evita li ddaħħal kontaminazzjoni.
English: 4.6 Adverse reactions (frequency and seriousness)
Maltese: 4.6 Reazzjonijiet mhux mixtieqa (frekwenza u gravità)
English: {MM/YYYY}
Maltese: {numru}
English: La Relva s/n, 36400 Porriño
Maltese: CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño
English: Date of first authorisation: 21/11/2017
Maltese: Data tal-ewwel awtorizzazzjoni: 21/11/2017
English: Purified saponin (Quil A)
Maltese: Saponin purifikat (Quil A)
English: Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, water for injections)
Maltese: Phosphate buffered saline (sodium chloride, disodium phosphate u potassium phosphate, ilma għallinjezzjonijiet)
English: 0.1 mg For the full list of excipients, see section 6.1.
Maltese: 0.1 mg Għal-lista sħiħa ta' eċċipjenti, ara s-sezzjoni 6.1.
English: Aluminium hydroxide Purified saponin (Quil A) Thiomersal
Maltese: Aluminium hydroxide Saponin ippurifikat (Quil A) Thiomersal
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)
English: BATCH NUMBER
Maltese: Lott: numru
English: 31 days after the second dose.
Maltese: 31 jum wara t-tieni doża.
English: High density polyethylene (HDPE) bottles of 52 ml, 100 ml or 252 ml with bromobutyl stoppers and aluminium seals.
Maltese: Fliexken ta' polyethylene b'densità għolja (HDPE) ta' 52 ml, 100 ml jew 252 ml b'tapp tal-bromobutyl u b'siġilli tal-aluminju.
English: Adjuvants:
Maltese: Eċċipjenti:
English: Bovilis Blue-8 stimulates active immunity against bluetongue virus, serotype 8.
Maltese: BOVILIS BLUE-8 jistimula l-immunità attiva kontra l-virus tal-Bluetongue, serotip 8
English: Store and transport refrigerated (2 ºC - 8 ºC).
Maltese: Aħżen u ttrasporta fil-friġġ (2 ºC - 8 ºC).
English: Package sizes:
Maltese: Daqs tal-pakkett:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Ewropea għall-Mediċini (http://www.ema.europa.eu/)
English: Occasionally a slight increase of the temperature (0.5 ºC - 1.0 ºC) is observed for 24-48 hours after the administration of a double dose of the vaccine.
Maltese: Xi drabi tkun osservata żieda żgħira fit-temperatura (0.5 ºC - 1.0 ºC) għal 24-48 siegħa wara li tkun amministrata doża doppja tal-vaċċin.
English: White or pinkish-white.
Maltese: Doża waħda fis-sena.
English: Manufacturer responsible for batch release: Intervet UK Ltd
Maltese: Intervet UK Ltd
English: Temporary local reactions can occur very rarely at the injection site in the form of a nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest and which may be painful.
Maltese: F'każijiet rari ħafna, iseħħu reazzjonijiet lokali temporanji fil-post tal-injezzjoni fil-forma ta' għoqiedi li huma ta' 0.5 sa 1 cm fin-nagħaġ u ta' 0.5 sa 3 cm fil-frat li jgħibu fi żmien 14-il jum u li jistgħu jkunu ta' wġigħ.
English: Zero days.
Maltese: 2 snin.
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/KE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonali tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, il-pussess, 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: Sheep from 2.5 months of age:
Maltese: Nagħaġ mill-età ta' 2.5 xhur:
English: Wim de Körverstraat 35, 5831 AN Boxmeer The NETHERLANDS
Maltese: Wim de Körverstraat 35, 5831 AN Boxmeer
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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew 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 użati bħal f'dan il-prodott mediċinali veterinarju.
English: Inactivated BTV8: 106.5 CCID50/ml
Maltese: BTV8:106.5
English: Transient fever was observed in rare cases.
Maltese: F'każijiet rari kien osservat deni temporanju.
English: An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle.
Maltese: Żieda medja fit-temperatura tal-ġisem li tvarja bejn 0.5 u 1.0 ºC hija reazzjoni komuni osservata finnagħaġ u l-frat.
English: Box with 1 bottle of 52 ml, 100 ml or 252 ml.
Maltese: Kaxxa bi flixkun 1 ta` 52ml, 100ml jew 252 ml.
English: PSUR submissions for Bovilis Blue-8 shall be synchronised and submitted at the same frequency as for Bluevac BTV8.
Maltese: għandhom jiġu sinkronizzati u sottomessi bl-istess frekwenza bħal dik għall-Bluevac BTV8.
English: Hypersensitivity reactions are very rarely observed.
Maltese: Reazzjonijiet ta' sensittività eċċessiva huma rari ħafna.
English: Each ml contains: Inactivated BTV8: 106.5 CCID50
Maltese: Antiġen ta' BTV8:106.5
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, il-vaċċin għandu jintuża biss skont il-valutazzjoni ta' benefiċċju/riskju mill-veterinarju responsabbli u/jew mill-awtoritajiet kompetenti nazzjonali dwar il-politika attwali ta' tilqim kontra lvirus tal-bluetongue (BTV).
English: Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.
Maltese: F'ċerti każijiet, il-preżenza ta' antikorpi derivati mill-omm f'ovini ta' età minima rrakkomandata jistgħu jinterferixxu mal-protezzjoni provduta mit-tilqima.
English: Pharmacotherapeutic group: Immunologicals for Bovidae/Ovidae, inactivated bluetongue virus vaccines.
Maltese: Immunoloġiċi għall-baqar/nagħaġ, vaċċini inattivat tal-virus talBluetongue.
English: Shelf life after first opening the container: 10 hours.
Maltese: Ladarba jiġi dilwit uża fi żmien: 10 sigħat.
English: Cattle from 2.5 months of age:
Maltese: Frat minn età ta' 2.5 xahar:
English: 20 days after the second dose.
Maltese: 20 jum wara t-tieni doża
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (52 ml, 100 ml and 252 ml)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun ta' (52 ml, 100ml, 252 ml)
English: Name and address of the manufacturer of the biological active substance CZ Veterinaria, S.A.
Maltese: Isem u indirizz tal-manufattur tas-sustanza bijoloġika attiva
English: Bluetongue virus inactivated, serotype 8 106.5 CCID50* Aluminium hydroxide
Maltese: Virus inattivat tal-Bluetongue, serotip 8: 106.5
English: Painless swellings occur occasionally with a size up to 2 cm in sheep and up to 4.5 cm in cattle after a double dose.
Maltese: Xi drabi jista' jkun hemm nefħa mingħajr uġigħ ta' daqs sa 2 cm fin-nagħaġ u sa 4.5 cm fil-frat wara doża doppja.
English: Bovilis Blue-8 suspension for injection for cattle and sheep
Maltese: Bovilis Blue-8 suspensjoni għal injezzjoni għall-frat u n-nagħaġ
English: It lasted not longer than 24 to 48 hours.
Maltese: Din damet mhux aktar minn 24 sa 48 siegħa.
English: Interaction with other medicinal products and other forms of interaction:
Maltese: Interazzjoni ma' prodotti mediċinali oħrajn u forom oħrajn ta' interazzjoni:
English: OTHER INFORMATION
Maltese: IT-TEST
English: No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.
Maltese: M'hemm l-ebda informazzjoni disponibbli dwar l-użu tal-vaċċin f'bhejjem seropożittivi, inkluż dawk b'antikorpi li ġejjin mill-omm.
English: Cattle: QI02AA08 / Sheep: QI04AA02 Bovilis Blue-8 stimulates active immunity against bluetongue virus, serotype 8.
Maltese: Bovilis Blue- 8 jistimula immunità attiva kontra l-virus tal-bluetongue, serotip 8 Daqs tal-pakkett:
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 ta' tilqim mill-ġdid għandu jsir qbil dwarha mill-awtorità kompetenti jew mill-veterinarju responsabbli, filwaqt li tiġi kkunsidrata s-sitwazzjoni epidemjoloġika lokali.
English: 100 ml 252 ml
Maltese: Flixkun ta' 100 ml Flixkun ta' 252 ml
English: Administer two doses of 4 ml subcutaneously with a 3 week interval.
Maltese: Agħti żewġ dożi ta' 4 ml taħt il-ġilda b'intervall ta' 3 ġimgħat.
English: Bluetongue virus inactivated, serotype 8: 106.5 CCID50* (* equivalent to titre prior to inactivation)
Maltese: CCID50* (*) ekwivalenti għal titrazzjoni qabel l-inattivazzjoni (log10)
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Maltese: .6 Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użati jew skart derivat mill-użu ta' dawn il-prodotti
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: (http://www.ema.europa.eu/)
English: 52 ml 100 ml 252 ml
Maltese: flixkun ta' 52 ml flixkun ta' 100 ml flixkun ta' 252 ml
English: (* equivalent to titre prior to inactivation)
Maltese: 0.1 mg (*ekwivalenti għal Titrazzjoni qabel l-inattivazzjoni)
English: Each ml of vaccine contains:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Batch{number}
Maltese: Jiskadi{xahar/sena}
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Maltese: b) il-marda li għaliha l-prodott huwa intiż li jagħti immunità hija ġeneralment assenti mit-territorju konċernat.
English: It is given over 15 to 60 minutes.
Maltese: Din tingħata fuq 15 sa 60 minuta.
English: In vitro data
Maltese: Data in vitro
English: In vivo data
Maltese: Data in vivo
English: • Convulsion.
Maltese: • Konvulsjoni.
English: System organ class
Maltese: Sistema ta' klassifika talorgani
English: Aspartame (E951): a source of phenylalanine.
Maltese: • Aspartame (E951): sors ta' phenylalanine.
English: Double vision (diplopia).
Maltese: • Vista doppja (diplopja).
English: (3) Reported in open-label studies.
Maltese: (3) Irrappurtata fi studji open-label.
English: Chemin du Foriest B-1420 Braine-L'Alleud BELGIUM
Maltese: Chemin du Foriest B-1420 Braine-L'Alleud
English: 40789 Monheim am Rhein GERMANY
Maltese: 40789 Monheim am Rhein IL-ĠERMANJA
English: Syncope(2) Coordination abnormal
Maltese: Sinkope (2) Ko-ordinazzjoni abnormali
English: The adjusted absolute difference between treatments was -1.3 % (95 % CI: -5.5, 2.8).
Maltese: 3% (95 % CI: -5.5, 2.8).
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: • għandek marda tal-qalb severa bħal insuffiċjenza tal-qalb jew kellek attakk tal-qalb.
English: Packs of 1x20 ml and 5x20 ml.
Maltese: Pakketti ta' 1x20 ml u 5x20ml.
English: Clinical efficacy and safety Adult population
Maltese: Effikaċja klinika u sigurtà Popolazzjoni adulta
English: Risk related to lacosamide
Maltese: Riskju relatat ma' lacosamide
English: Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Lacosamide UCB patients and 0 % (0/356) of placebo patients.
Maltese: Livelli għolja ta' ALT sa ≥3x ULN seħħew f' 0.7% (7/935) tal-pazjenti fuq Lacosamide UCB u 0% (0/356) tal-pazjenti fuq plaċebo.
English: Lacosamide UCB syrup contains sorbitol (E420).
Maltese: Lacosamide UCB mistura fiha sorbitol (E420).
English: The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a functionalised amino acid.
Maltese: Is-sustanza attiva, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) huwa amino-aċidu funzjonalizzat.
English: Titration (incremental steps)
Maltese: Titrazzjoni (passi inkrimentali)
English: 5 x 20 ml solution for infusion
Maltese: 5 x 20 ml soluzzjoni għall-infużjoni
English: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.
Maltese: GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Ġermanja.
English: 200 mg tablet: indigo carmine aluminium lake (E132).
Maltese: Pilloli 200 mg: indigo carmine aluminium lake (E132).
English: Partial-onset seizures have a similar clinical expression in children from 4 years of age and in adults.
Maltese: Aċċessjonijiet ta' feġġa parzjali għandhom espressjoni klinika simili fi tfal minn 4 snin ta' età u fladulti.
English: Erythema(4)
Maltese: Eritema(4)
English: 100 mg tablet: yellow iron oxide (E172).
Maltese: Pilloli 100 mg: yellow iron oxide (E172).
English: In vitro studies indicate that the enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP2E1 are not inhibited by lacosamide at plasma concentrations observed in clinical trials.
Maltese: Studji in vitro juru li enżimi CYP1A2, CYP2B9, u CYP2C9 ma kienux indotti u li CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6, u CYP2E1 ma kienux inhibiti minn lacosamide fil-konċentrazzjonijiet tal-plażma osservati fil-provi kliniċi.
English: Angioedema(1) Urticaria(1)
Maltese: Anġjodema(1) Urtikarja(1)
English: Summary of safety profile
Maltese: Sommarju tal-profil ta' sigurta`
English: Tablet core microcrystalline cellulose hydroxypropylcellulose hydroxypropylcellulose (low substituted) silica, colloidal, anhydrous crospovidone (polyplasdone XL-10 Pharmaceutical Grade) magnesium stearate
Maltese: Il-qalba tal-pillola microcrystalline cellulose hydroxypropylcellulose hydroxypropylcellulose (low substituted) silica, colloidal, anhydrous crospovidone (polyplasdone XL-10
English: Depression Confusional state Insomnia(1)
Maltese: Depressjoni Stat konfużjonali Insomnja(1)
English: • The other ingredients are glycerol (E422), carmellose sodium, sorbitol liquid (crystallizing) (E420), polyethylene glycol 4000, sodium chloride, citric acid anhydrous, acesulfame potassium (E950), sodium methyl parahydroxybenzoate (E219), strawberry flavour (contains propylene glycol, maltol), masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water), purified water.
Maltese: • L-ingredjenti l-oħra huma: glycerol (E422), carmellose sodju, sorbitol liquid (crystallizing) (E420), polyethylene glycol 4000, sodium chloride, citric acid (anhydrous), acesulfame potassium (E950), sodju methylparahydroxybenzoate (E219), propylene glycol, aspartame (E951), maltol, togħma ta' frawli (contains propylene glycol, maltol), masking flavour (li fih propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water), ilma purifikat.
English: Ltd Τηλ: + 357 22 34 74 40
Maltese: Lifepharma (Z.A.M.) Ltd Τηλ: + 357 22 34 74 40
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR, syncope was reported in 7/444 (1.6 %) lacosamide patients and in 1/442 (0.2 %) carbamazepine CR patients.
Maltese: F'prova kliniċa ta' monterapija li tqabbel lacosamide ma' carbamazepine CR, sinkope kien irrapportat f'7/444 (1.6%) pazjenti fuq lacosamide u f'1/442 (0.2%) pazjenti fuq carbamazepine CR.
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussel, Belġju.