FrancophonIA/ELRC3.0 huggingface dataset:
English: The inspection of the Castlebar site by the supervisory authority (IMB) shall be performed by end of December 2011 before the solutions can be re-launched.
Maltese: L-ispezzjoni tas-sit ta' Castlebar mill-awtorità ta' sorveljanza (IMB) għandha ssir sal-aħħar ta' Diċembru 2011 qabel ma s-soluzzjonijiet ikunu jistgħu jiġu mnedija mill-ġdid.
English: The outcome of the global CAPA shall be provided to the national competent authorities and any changes considered necessary shall be addressed through the appropriate change management protocols and regulatory procedures at a national level, as applicable.
Maltese: L-eżitu tal-CAPA globali għandu jiġi ppreżentat lill-awtoritajiet nazzjonali kompetenti u kull bidla li titqies meħtieġa għandha tkun indirizzata permezz tal-protokolli ta' ġestjoni tal-bidla u tal-proċeduri regolatorji xierqa fil-livell nazzjonali, kif applikabbli.
English: Further information on Ubac can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Ubac (Streptococcus uberis vaccine, inactivated)
Maltese: Ubac (Streptococcus uberis vaccine, inattivat)
English: Ubac (Streptococcus uberis vaccine, inactivated) EMA/296128/2018
Maltese: Ubac (Streptococcus uberis vaccine, inattivat) EMA/528112/2018
English: Ubac received a marketing authorisation valid throughout the EU on 26 July 2018.
Maltese: Ubac ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 26/07/2018.
English: Ubac contains the active substance called biofilm adhesion component including lipoteichoic acid, which is derived from the sticky film produced by Streptococcus uberis strain 5616.
Maltese: Ubac fih is-sustanza attiva msejħa komponent ta' adeżjoni tal-biofilm li tinkludi llipoteichoic acid, li jiġi mill-film li jweħħel prodott minn Streptococcus uberis razza 5616.
English: The most common side effects with UBAC (which may affect more than 1 in 10 animals) are a shortlived increase in rectal temperature of around 1 - 2 ºC within 24 hours of injection and a local injection site swelling of more than 5 cm in diameter.
Maltese: L-effetti sekondarji l-aktar komuni b'Ubac (li jistgħu jaffettwaw aktar minn annimal 1 minn kull 10) huma żieda li ma ddumx fit-temperatura tar-rektum ta' madwar 1 - 2ºC fi żmien 24 siegħa millinjezzjoni u nefħa fis-sit tal-injezzjoni lokali ta' dijametru ta' aktar minn 5 cm.
English: During a 21 week observation period the incidence of new cases of S. uberis clinical mastitis was 50% lower in the group of 277 cattle vaccinated with Ubac compared to the group of 303 cattle given placebo (dummy treatment) (6.1% versus 12.2%).
Maltese: Matul perjodu ta' osservazzjoni ta' 21 ġimgħa, l-inċidenza ta' każijiet ġodda ta' mastite klinika ta' S. uberis kienet 50 % aktar baxxa fil-grupp ta' 277 frat imlaqqma b'Ubac, meta mqabbel mal-grupp ta' 303 ifrat li ngħata plaċebo (kura finta)
English: Other information about Ubac
Maltese: Informazzjoni oħra dwar Ubac
English: What are the risks associated with Ubac?
Maltese: X'inhuma r-riskji assoċjati ma' Ubac?
English: Ubac is a vaccine.
Maltese: Ubac huwa vaċċin.
English: The vaccine also contains ‘adjuvants' (Montanide ISA and MPLA) to stimulate a better reaction by the immune system.
Maltese: Il-vaċċin fih ukoll "aġġuvanti" (Montanide ISA u MPLA) biex jistimula reazzjoni aħjar mis-sistema immunitarja.
English: This will help protect the cattle against the infection and reduce the risk of mastitis.
Maltese: Dan ser jgħin jipproteġi lill-ifrat kontra l-infezzjoni u jnaqqas ir-riskju ta' mastite.
English: The injection site swelling usually disappears or reduces in size by 17 days after vaccination but in some cases the swelling may last for up to 4 weeks.
Maltese: In-nefħa tas-sit talinjezzjoni normalment tisparixxi jew titnaqqas fid-daqs fi żmien 17-il jum wara t-tilqim imma f'ċerti każijiet in-nefħa tista' ddum sa 4 ġimgħat.
English: The full course should be repeated with each pregnancy.
Maltese: Il-kors sħiħ għandu jiġi ripetut ma' kull tqala.
English: Protection starts about 36 days after the second injection and lasts for the first 5 months of lactation (milk production).
Maltese: Il-protezzjoni tibda madwar 36 jum wara t-tieni injezzjoni u ddum sal-ewwel 5 xhur ta' treddigħ (produzzjoni tal-ħalib).
English: Ubac is a vaccine used in cows and heifers (female cattle that have not yet calved) to reduce clinical mastitis (udder infections with visible signs in milk or the udder) caused by bacteria called Streptococcus uberis, which can reduce milk production.
Maltese: Ubac huwa vaċċin użat fil-baqar u fl-erieħ (baqar li għadhom ma welldux) biex titnaqqas il-mastite klinika (infezzjonijiet fil-bżieżel b'sinjali viżibbli fil-ħalib jew fil-bżieżel) ikkawżata minn batterji msejħa Streptococcus uberis, li jistgħu jnaqqsu l-produzzjoni tal-ħalib.
English: The first injection is given at about 60 days before the expected calving date followed by a second injection given at least 3 weeks before the expected calving date.
Maltese: L-ewwel injezzjoni tingħata madwar 60 jum qabel id-data mistennija tat-twelid segwita mit-tieni injezzjoni li tingħata mill-inqas 3 ġimgħat qabel id-data mistennija tat-twelid.
English: The active substance in Ubac is obtained from the sticky substances that the S. uberis bacteria produce to protect themselves and attach to surfaces (known as biofilm adhesion components).
Maltese: Is-sustanza attiva f'Ubac tinkiseb mis-sustanzi li jweħħlu prodotti mill-batterji ta' S. uberis biex jipproteġu lilhom infushom u li jeħlu ma' uċuh (magħrufin bħala komponenti ta' adeżjoni ta' biofilm).
English: The package leaflet should be shown to the doctor.
Maltese: Ilmerħla kollha għandha tiġi mlaqqma.
English: A field study involved 6 farms with a history of S. uberis clinical mastitis and recently confirmed presence of S. uberis infection.
Maltese: Studju fuq il-post involva 6 irziezet bi storja ta' mastite klinika ta' S. uberis u preżenza kkonfermata riċentement ta' infezzjoni ta' S. uberis.
English: How is Ubac used?
Maltese: Kif jaħdem Ubac?
English: Ubac is also used to reduce the somatic cell count (SCC) in milk, which is a measure of mastitis without visible signs (subclinical mastitis).
Maltese: Ubac jintuża wkoll biex inaqqas l-għadd taċ-ċelluli somatiċi (SCC, somatic cell count) fil-ħalib, li huwa kejl tal-mastite mingħajr sinjali viżibbli (mastite subklinika).
English: Ubac is given as a course of 3 injections into the neck muscles, alternating sides of the neck.
Maltese: Ubac jingħata bħala kors ta' 3 injezzjonijiet fil-muskoli tal-għonq, naħat alternati tal-għonq.
English: How does Ubac work?
Maltese: Kif jintuża Ubac?
English: Subcutaneous use pre-filled syringe 1 ml (50 mg/ml) 12 (3 x 4) pre-filled syringes (multipack)
Maltese: 12-il (3 x 4) siringa mimlija għal-lest (pakkett multiplu)
English: Subcutaneous use pre-filled syringe 1 ml (50 mg/ml) 4 pre-filled syringes
Maltese: 0.51 mL (50 mg/mL) 4 siringi mimlija għal-lest
English: Subcutaneous use pre-filled pen 1 ml (50 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Maltese: 12-il (3 x 4) pinna mimlija għal-lest (pakkett multiplu)
English: 4 pre-filled syringes
Maltese: 4 siringi mimlija għal-lest
English: EMA/762197/2010 EMEA/H/C/000689
Maltese: EMEA/H/C/000689
English: It is available as tablets (100 and 1,000 mg).
Maltese: Jiġi bħala pilloli (100 u 1,000 mg).
English: This summary was last updated in 03-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2014.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Siklos can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Siklos huwa disponibbli fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR for Siklos can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Siklos jista' jinstab fs-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Siklos.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Siklos.
English: The starting dose is usually 15 mg per kilogram body weight, using the most appropriate tablet strengths (100 or 1,000 mg) to make up the dose, breaking up the 1,000-mg tablet in quarters (250 mg) if needed.
Maltese: Id-doża tal-bidu hija normalment 15 mg għal kull kilogramma ta' piż tal-ġisem, bl-użu tad-dożaġġ l-aktar adatt (100 jew 1,000 mg), fejn il-pillola ta' 1,000 mg tinqasam f'erba' kwarti (250 mg) jekk ikun meħtieġ.
English: Siklos is a medicine that contains the active substance hydroxycarbamide.
Maltese: Siklos hu mediċina li fiha s-sustanza attiva idrossikarbammid.
English: What is Siklos?
Maltese: X'inhu Siklos?
English: What is the risk associated with Siklos?
Maltese: X'inhu r-riskju assoċjat ma' Siklos?
English: Siklos hydroxycarbamide
Maltese: Għal xhiex jintuża Siklos?
English: Other information about Siklos
Maltese: Siklos idrossikarbammid
English: The dose is adjusted according to the response to treatment, with the usual dose being between 15 and 30 mg per kilogram body weight per day.
Maltese: Id-doża tiġi aġġustata skont ir-rispons għat-trattament, bid-doża normali tkun bejn 15 u 30 mg kuljum għal kull kilogramma ta' piż tal-ġisem.
English: It also presented evidence from one study in 299 adults, in which the effects of Siklos were compared with those of placebo (a dummy treatment), as well as the results of other studies involving 430 adults and one national registry of information on 123 adults treated with Siklos.
Maltese: Hija ppreżentat ukoll evidenza minn studju wieħed f'299 adult, fejn l-effetti ta' Siklos tqabblu ma' dawk ta' plaċebo (trattament finta), kif ukoll ir-riżultati ta' studji oħrajn li involvew 430 adult u reġistru nazzjonali wieħed ta' tagħrif dwar 123 adult ittratti b'Siklos.
English: In particular, it presented evidence on the effectiveness of Siklos from 11 published studies involving 378 children and from three national registries of information on 155 children with sickle cell syndrome who were treated with Siklos for up to seven years.
Maltese: B'mod partikolari, hija ppreżentat evidenza dwar l-effettività ta' Siklos minn 11-il studju ppubblikat li fihom ħadu sehem 378 tifel u tifla u minn tliet reġistri nazzjonali ta' tagħrif dwar 155 tifel u tifla bis-sindromu sickle cell li kienu ttrattati b'Siklos għal seba' snin.
English: Patients had fewer vaso-occlusive crises when treated with Siklos than before treatment, with the frequency falling by between 66% and 80% in children and adults.
Maltese: Il-pazjenti kellhom inqas kriżijiet vaso-okklusivi meta ġew trattati b'Siklos milli qabel it-trattament, bilfrekwenza tonqos b'bejn 66% u 80% fit-tfal u l-adulti.
English: The 1,000 mg tablet has special score lines so that it can be easily divided into four equal parts.
Maltese: Ilpillola ta' 1,000 mg għandha linji mnaqqxa speċjali biex tkun tista' tinqasam faċilment f'erba' biċċiet indaqs.
English: Because the number of patients with sickle cell syndrome is low, the disease is considered ‘rare', and Siklos was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2003.
Maltese: Billi l-għadd ta' pazjenti li jbatu mis-sindromu sickle cell huwa baxx, il-marda hi meqjusa 'rari' u Siklos ġie kklassifikat bħala 'mediċina orfni' (mediċina użata fil-mard rari) fid-9 ta' Lulju 2003.
English: Why has Siklos been approved?
Maltese: Għaliex ġie approvat Siklos?
English: A risk management plan has been developed to ensure that Siklos is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Siklos jintuża bl-aktar mod sigur possibbli.
English: Treatment with Siklos should be started by a doctor who has experience in the management of sickle cell syndrome.
Maltese: It-trattament b'Siklos għandu jinbeda minn tabib li jkollu esperjenza fil-ġestjoni tas-sindromu sickle cell.
English: How has Siklos been studied?
Maltese: Kif ġie studjat Siklos?
English: In the study comparing Siklos with placebo in adults, there were fewer vaso-occlusive crises in the patients taking Siklos (2.5 crises per year) than in those taking placebo (4.5 crises per year).
Maltese: Fl-istudju fejn Siklos tqabbel ma' plaċebo fl-adulti, kien hemm inqas kriżijiet vaso-okklusivi fil-pazjenti li ħadu Siklos (2.5 kriżijiet kull sena) milli f'dawk li ħadu plaċebo (4.5 kriżijiet kull sena).
English: What measures are being taken to ensure the safe and effective use of Siklos?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw użu sigur u effettiv ta' Siklos?
English: The most common side effect with Siklos (seen in more than one patient in 10) is bone marrow suppression, causing neutropenia (low levels of neutrophils, a type of white blood cell), reticulocytopenia (low levels of reticulocytes, a type of immature red blood cell) and macrocytosis (enlargement of red blood cells).
Maltese: L-effett sekondarju l-aktar komuni b'Siklos (li deher f'aktar minn pazjent wieħed minn kull għaxra) hu s-sopressjoni tal-mudullun tal-għadam, li jwassal għal newtropenja (livelli baxxi ta' newtrofili, tip ta' ċelloli tad-demm bojod), retikuloċitopenja (livelli baxxi ta' reticulocytes, tip ta' ċelloli tad-demm ħomor immaturi) u makroċitosi (tkabbir taċ-ċelloli ħomor tad-demm).
English: Siklos is used in adults, adolescents and children over two years of age who have sickle cell syndrome, a genetic disease where the red blood cells become rigid and sticky, and change from being discshaped to being crescent-shaped (like a sickle).
Maltese: Siklos jintuża f'adulti, adoloxxenti u tfal 'il fuq minn sentejn li għandhom is-sindromu sickle cell, marda ġenetika fejn iċ-ċelloli ħomor tad-demm isiru riġidi u jwaħħlu, u jinbidlu minn forma ta' disk għal forma ta' nofs qamar (bħal minġel).
English: The active substance in Siklos, hydroxycarbamide, blocks the growth and reproduction of some cells, such as blood cells.
Maltese: Is-sustanza attiva f'Siklos, l-idrossikarbammid, tinibixxi l-kobor u r-riproduzzjoni ta' xi ċelloli, bħaċċelloli tad-demm.
English: Hydroxycarbamide, which used to be known as hydroxyurea, has been available in the European Union (EU) for several decades for use in other illnesses, including some types of cancer.
Maltese: L-idrossikarbammid, li qabel kien magħruf bħala idrossiurea, ilu disponibbli fl-Unjoni Ewropea (UE) għal diversi għexieren ta' snin jintuża għal mard ieħor oħra, inkluż xi tipi ta' kanċer.
English: They can include acute chest syndrome, a life-threatening condition when the patient has sudden chest pain, fever, hard breathing or signs of fluid in the lungs on an X ray.
Maltese: Jistgħu jinkludu s-sindromu akut tal-pulmun, kondizzjoni perikoluża għall-ħajja meta l-pazjent ikollu wġigħ immedjat f'sidru, deni, tbatija fin-nifs jew sinjali ta' fluwidu fil-pulmun fir-raġġi X.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Siklos on 29 June 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Siklos valida fl-Unjoni Ewropea kollha fid-29 ta' Ġunju 2007.
English: For the full list of all side effects reported with Siklos, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati b'Siklos, ara lfuljett ta' tagħrif.
English: The effects were sustained for up to seven years.
Maltese: L-effetti ġew sostnuti għal seba' snin.
English: The studies compared the number of vaso-occlusive crises before and after treatment with Siklos, as defined by any painful episode involving the arms, legs, abdomen, back or chest.
Maltese: L-istudji qabblu n-numru ta' kriżijiet vaso-okklusivi qabel u wara t-trattament b'Siklos, kif definit bi kwalunkwe episodju ta' wġigħ fid-dirgħajn, is-saqajn, iż-żaqq, id-dahar u s-sider.
English: Siklos, reversible oligospermia or azoospermia (reduced or absent production of healthy sperm) is also very commonly seen.
Maltese: Fl-irġiel ikkurati b'Siklos, oligospermia jew azoospermia reversibbli (tnaqqis jew nuqqas fil-produzzjoni ta' sperma f'saħħitha) tokkorri ta' spiss.
English: The number of cases of acute chest syndrome also fell by 25 to 33%.
Maltese: In-numru ta' każijiet tas-sindromu akut tassider ukoll naqset b'bejn 25 u 33%. Kien hemm ukoll inqas pazjenti li kellhom bżonn jiddaħħlu l-isptar, u inqas jiem imqattgħin l-isptar.
English: Because hydroxycarbamide is a well-known substance that is already used in other medicines, the company used data from the scientific literature to support the use of Siklos in adults and children with sickle cell syndrome.
Maltese: Billi l-idrossikarbammid hu sustanza magħrufa sew li tintuża diġà f'mediċini oħra, il-kumpanija użat dejta mil-letteratura xjentifika biex tappoġġja l-użu ta' Siklos fl-adulti u t-tfal li għandhom is-sindromu sickle cell.
English: How is Siklos used?
Maltese: Kif jaħdem Siklos?
English: How does Siklos work?
Maltese: Kif jintuża Siklos?
English: Siklos is taken once a day, preferably in the morning before breakfast.
Maltese: Siklos jittieħed darba kuljum, preferibbilment filgħodu qabel il-kolazzjon.
English: It is used to prevent recurrent, painful vaso-occlusive crises that happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to an organ.
Maltese: Il-mediċina tintuża għall-prevenzjoni ta' kriżijiet vaso-okklusivi rikorrenti u li jweġġgħu li jseħħu meta l-arterji u l-vini tad-demm jinstaddu minn ċelloli tad-demm ħomor anormali, b'hekk inaqqsu l-fluss tad-demm lejn xi organu.
English: Cattle (calves and young cattle) and pigs.
Maltese: Baqar (għoġġiela u baqar żgħar) u majjali
English: Oral suspension
Maltese: Suspensjoni orali
English: See also section 4.7.
Maltese: Ara wkoll sezzjoni 4.7.
English: Co. Galway,
Maltese: Galway,
English: Virbac Norge c/o Premium Pet Products Vollaveien 20 A 0614 Oslo
Maltese: Virbac Norge c/o Premium Pet Products Vollaveien 20 A 0614
English: Eurovet Animal Health B.V. Handelsweg 25, 5531 AE Bladel, The Netherlands
Maltese: Eurovet Animal Health B.V. Handelsweg 25, 5531 AE Bladel, L-Olanda
English: VIRBAC Sp. o.o.
Maltese: VIRBAC Sp. o.o. ul.
English: Glucose monohydrate
Maltese: Glukosju monohydrate
English: Lot {number}
Maltese: Lot{numru}.
English: E-mail: info@virbac.gr, www.virbac.gr
Maltese: E-mail: , www.virbac.gr
English: Apple flavour (containing butylated hydroxyanisole (E320)) Crospovidone
Maltese: Togħma Apple (li fih hydroxyanisole butylated (E320)) Crospovidone
English: 20 tablets 100 tablets
Maltese: 20 pillola 100 pillola
English: Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca (P.O.Box 40261, 6302 Larnaca) Tel: + 357 24813333
Maltese: Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca (P.O.Box 40261, 6302 Larnaca)
English: Elimination Meloxicam is eliminated with a terminal half-life of 7.7 hours.
Maltese: Eliminazzjoni Meloxicam jiġi eliminat b'half-life terminali ta' 7.7 sigħat.
English: Luxembourg/Luxemburg VIRBAC BELGIUM N.V. Esperantolaan 4
Maltese: Luxembourg/Luxemburg VIRBAC BELGIUM N.V.
English: België/Belgique/Belgien VIRBAC BELGIUM N.V. Esperantolaan 4
Maltese: België/Belgique/Belgien VIRBAC BELGIUM N.V.
English: Lactose monohydrate Silicified microcrystalline cellulose Sodium acid citrate Crospovidone
Maltese: Lactose monohydrate Silicified microcrystalline cellulose Sodium acid citrate Krospovidone
English: - Ethanol (96%) - Poloxamer 188 - Macrogol 400 - Glycine - Disodium edetate - Sodium hydroxide - Hydrochloric acid, concentrated - Meglumine - Water for injections
Maltese: - Ethanol (96%) - Poloxamer 188 - Macrogol 400 - Glycine - Disodium edetate - Sodium hydroxide - Hydrochloric acid - Meglumine - Ilma għall-injezzjoni
English: Maximum number of piercings is 42 for all presentations.
Maltese: Numru massimu ta' fetħiet huwa 42 għall-preżentazzjonijiet kollha.
English: Paper foil sachets (paper/PE/alu/PE) containing 1.5 g granules per sachet in a cardboard box.
Maltese: Qratas tal-paper foil (karta/PE/alu/PE) li fihom 1.5 g granuli għal kull qartas f'kaxxa tal-kartun.
English: ATCvet code: QM01AC06.
Maltese: QM01AC06.
English: MRL
Maltese: LMR
English: Magnesium stearate
Maltese: Togħma ta' majjal Magnesium stearate
English: Active substance Meloxicam
Maltese: Sustanza attiva Meloxicam
English: Date of first authorisation: 09/12/2011 Date of last renewal: 09/11/2016
Maltese: Data tal-aħħar tiġdid: 09/11/2016
English: EXP {month/year}
Maltese: EXP {xahar/sena}.
English: For example, a horse weighing 400 kg will receive 16 ml of Inflacam, a horse weighing 500 kg will receive 20 ml of Inflacam, and a horse weighing 600 kg will receive 24 ml of Inflacam.
Maltese: Per eżempju, żiemel li jiżen 400 kg se jirċievi 16 ml ta' Inflacam, żiemel li jiżen 500 kg se jirċievi 20 ml ta' Inflacam, u żiemel li jiżen 600 kg se jirċievi 24 ml ta' Inflacam.
English: BN{number}
Maltese: {GĦAMLA/TIP}
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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 trattati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal trattati ) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal trattati ) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal trattati ) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal trattati , inklużi rapporti iżolati).
English: STATEMENT OF ACTIVE SUBSTANCES
Maltese: Sustanza attiva
English: Excipient Sodium benzoate 1.5 mg
Maltese: Sodium benzoate 1.5 mg
English: See section "Contraindications".
Maltese: Ara s-sezzjoni `Kontraindikazzjonijiet´.
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritisagalactia syndrome) with appropriate antibiotic therapy.
Maltese: Għal terapija addizzjonali fit-trattament ta' settiċemija puwerperali u tossemija (sindrome mastite-metriteagalaktja) flimkien ma' terapija antibijotika adattata.
English: Active substance Meloxicam 330 mg.
Maltese: Sustanza attiva Meloxicam 330 mg.
English: Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Maltese: Meloxicam huwa metabolizzat għal alkoħol, derivattiv ta' aċidu u għal diversi metaboliti polari.
English: - Ethanol (96%) - Poloxamer 188 - Macrogol 400 - Glycine - Sodium hydroxide - Hydrochloric acid, concentrated - Meglumine - Water for injections.
Maltese: - Ethanol (96%) - Poloxamer 188 - Macrogol 400 - Glycine - Sodium hydroxide
English: 3771 ND-Barneveld Tel: + 31 (0) 342 427 127 info@virbac.nl
Maltese: 342 427 127 info@virbac.nl
English: A clinical response is normally seen within 3-4 days.
Maltese: Rispons kliniku ġeneralment ikun osservat wara 3-4 ijiem.
English: Reduction of post-operative pain (over a period of 24 hours):
Maltese: Tnaqqis tal-uġigħ ta' wara l-operazzjoni (matul perjodu ta' 24 siegħa):
English: Chronic musculoskeletal disorders: Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Maltese: Ir-rispons għat-terapija fit-tul għandu jkun immonitorjat f'intervalli regolari minn kirurgu veterinarju.
English: Bottle (HDPE)
Maltese: INDIKAZZJONI (JIET)
English: The major metabolites found in all species were the 5-hydroxyand 5-carboxy- metabolites and the oxalyl- metabolite.
Maltese: Il-metaboliti ewlenin li jinsabu f'kull speċi kienu l-metaboliti 5-hydroxy- u 5-carboxy u l-metabolit oxalyl.
English: Pack size: 20 and 100 sachets.
Maltese: Daqsijiet tal-pakketti: 20 u 100 qartas.