FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies indicate that the effect of ertapenem on the plasma protein binding of highly protein bound medicinal products (warfarin, ethinyl estradiol, and norethindrone) was small.
Maltese: Studji in vitro jindikaw li l-effett ta' ertapenem fuq il-ħila tal-irbit mal-proteini tal-plażma fi prodotti mediċinali li għandhom irbit qawwi mal-proteini (warfarin, ethinyl estradiol, norethindrone) huwa żgħir.
English: wheezing
Maltese: Mixxellanja
English: • Infection affecting the lungs (pneumonia)
Maltese: • Infezzjoni li taffettwa l-pulmuni (pnewmonja)
English: Uncommon: Headache Not known: Hallucinations
Maltese: Mhux komuni: Insomnja, konfużjoni
English: The recommended dose of INVANZ for adults and adolescents 13 years of age and older is 1 gram (g) given once a day.
Maltese: Id-doża rrakkomandata ta' INVANZ għall-adulti u adolexxenti minn 13-il sena 'l fuq hija ta' 1 gramma (g) mogħtija darba kuljum.
English: This medicinal product contains approximately 6.0 mEq (approximately 137 mg) of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.
Maltese: Dan prodott mediċinali fih madwar 6.0 mEq (madwar 137 mg) ta' sodium f'kull doża ta' 1.0 g u dan għandu jiġi kkunsidrat minn pazjenti fuq dieta kkontrollata tas-sodium.
English: Breast-feeding
Maltese: Il-manifattur
English: INVANZ is supplied in packs of 1 vial or 10 vials.
Maltese: INVANZ hu fornut f'pakketti ta' kunjett 1 jew 10 kunjetti.
English: Supplied in packs of 1 vial or 10 vials.
Maltese: Jiġi f'pakketti ta' kunjett wieħed jew 10 kunjetti.
English: There is relatively little experience with ertapenem in children less than two years of age.
Maltese: Hemm relattivament ftit esperjenza b'ertapenem fi tfal b'età inqas minn sentejn.
English: • Inflammation of the gall bladder, difficulty in swallowing, faecal incontinence, jaundice, liver disorder
Maltese: • Infjammazzjoni tal-bużżieqa tal-marrara, diffikultà biex tibla', inkontinenza tal-ippurgar,
English: • Abdominal pain, fatigue, fungal infection, fever, oedema/swelling, chest pain, abnormal taste
Maltese: Imnieħer imblukkat, sogħla, epistassi (tinfaraġ), ħsejjes talpulmun/respiratorji, tħarħir
English: • Non species related breakpoints: S ≤ 0.5 mg/L and R > 0.5 mg/L
Maltese: • Breakpoints mhux relatati mal-ispeċi: S≤ 0.5 mg/L u R >0.5 mg/L
English: • Muscle cramp, shoulder pain
Maltese: • Livell baxx taz-zokkor fid-demm
English: Reconstituted solutions should be diluted in sodium chloride 9 mg/mL (0.9 %) solution immediately after preparation.
Maltese: Soluzzjonijiet rikostitwiti għandhom jiġu dilwiti f'soluzzjoni 9 mg/mL (0.9 %) ta' sodium chloride minnufih wara l-preparazzjoni.
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
Maltese: Ġew rappurtati reazzjonijiet serji u xi kultant fatali ta' sensittività eċċessiva (anafilattiċi) f'pazjenti li kienu qed jingħataw terapija bil-beta-lactams.
English: For a bag of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a bag of sodium chloride 9 mg/mL (0.9 %) solution for a final concentration of 20 mg/mL or less; or
Maltese: Għal borża bid-dilwent: Ittrasferixxi volum ta' 15 mg/kg ta' piż korporju (li ma jridx jaqbeż il1 g/kuljum) f'borża b'soluzzjoni ta' 9 mg/mL (0.9%) ta' sodium chloride għal konċentrazzjoni finali ta' 20 mg/mL jew inqas; jew
English: Hepatic impairment
Maltese: Infezzjoni fuq oħra
English: Area under the plasma concentration curve (AUC) of ertapenem in adults increases nearly doseproportionally over the 0.5 to 2 g dose range.
Maltese: L-erja taħt il-kurva tal-konċentrazzjoni fil-plażma (AUC) ta' ertapenem fl-adulti tiżdied kważi proporzjonalment mad-doża f'medda ta' doża minn 0.5 sa 2 g.
English: Adults: To prevent surgical site infections following elective colorectal surgery, the recommended dosage is 1 g administered as a single intravenous dose to be completed within 1 hour prior to the surgical incision.
Maltese: Għal prevenzjoni ta' infezzjonijiet wara operazzjoni elettiva tal-kolon u r-rektum, id-dożaġġ rakkomandat hu ta' 1 g mogħti bħala doża waħda ġol-vini li jrid isir sa siegħa qabel l-inċiżjoni kirurġika.
English: Reconstitute the contents of a 1 g vial of INVANZ with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution to yield a reconstituted solution of approximately 100 mg/mL.
Maltese: Il-kontenut ta' kunjett ta' 1g ta' INVANZ għandu jiġu rikostitwit ma' 10 mL ta' ilma għall-injezzjoni jew ma' 9 mg/mL (0.9%) ta' soluzzjoni ta' sodium chloride biex jagħti soluzzjoni rikostitwita ta' bejn wieħed u ieħor 100 mg/mL.
English: For a vial of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a vial of sodium chloride 9 mg/mL (0.9 %) solution for a final concentration of 20 mg/mL or less.
Maltese: Ittrasferixxi volum ta' 15 mg/kg ta' piż korporju (li ma jridx jaqbeż il1 g/kuljum) f'kunjett b'soluzzjoni ta' 9 mg/mL (0.9%) ta' sodium chloride għal konċentrazzjoni finali ta' 20 mg/mL jew inqas.
English: • Skin redness, skin rash
Maltese: • Infezzjoni fiż-żaqq
English: Chlamydia species Mycoplasma species Rickettsia species Legionella species
Maltese: Is-soluzzjonijiet dilwiti għandhom jintużaw minnufih.
English: Uncommon: Constipation, acid regurgitation, dry mouth, dyspepsia, abdominal pain Rare: Dysphagia, faecal incontinence, pelvic peritonitis Not known: teeth staining
Maltese: Komuni: Dijarea, dardir, rimettar Mhux komuni: Stitikezza, rigurġitazzjoni tal-aċidu, ħalq xott, dispepsja, uġigħ fl-addome Rari: Problemi biex tibla', inkontinenza tal-ippurgar, peritonite tal-pelvi
English: In clinical studies for the treatment of community-acquired pneumonia, in adults, 25 % of evaluable patients treated with ertapenem had severe disease (defined as pneumonia severity index > III).
Maltese: Fi studji kliniċi għall-kura tal-pnewmonja li tittieħed mill-komunità, fl-adulti, 25% tal-pazjenti li setgħu jiġu evalwati u li ġew ikkurati b'ertapenem kellhom mard qawwi (definit fuq l-indiċi tal-qawwa tal-pnewmonja bħala > III).
English: INVANZ is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1):
Maltese: INVANZ huwa indikat għall-użu f'pazjenti pedjatriċi (b'età minn 3 xhur sa 17-il sena) u fl-adulti għall-kura tal-infezzjonijiet li jiġu kkawżati minn batterji li huma magħrufa jew x'aktarx li jkunu suxxettibbli għal ertapenem u meta hija meħtieġa terapija parenterali (ara sezzjonijiet 4.4 u 5.1):
English: Serratia marcescens
Maltese: Saff tal-Mard
English: The mean plasma half-life in children 3 months to 12 years of age is approximately 2.5 hours.
Maltese: Fit-tfal bejn it-3 xhur sat-12 ilsena il- medja tal-half life fil-plażma hija bejn wieħed u ieħor ta' 2.5 sigħat.
English: Repeated evaluation of the patient's condition is essential.
Maltese: Huwa essenzjali li ssir evalwazzjoni ripetuta tal-kundizzjoni tal-pazjent.
English: How to store INVANZ
Maltese: X'fih INVANZ
English: Children and adolescents (3 months to 17 years of age):
Maltese: Tfal u adolexxenti (minn 3 xhur sa 17-il sena):
English: • Changes in some laboratory blood and urine tests
Maltese: • Tibdiliet f'xi testijiet tal-laboratorju tad-demm u tal-awrina
English: At the 15 mg/kg dose, the AUC value and plasma concentrations at the midpoint of the dosing interval in patients 3 months to 12 years of age were comparable to those in young healthy adults receiving a 1 g intravenous dose of ertapenem.
Maltese: Fid-doża ta' 15 mg/kg, il-valur tal-AUC u konċentrazzjonijiet tal-plażma f'nofs l-intervall taddożaġġ f'pazjenti li kellhom minn 3 xhur sa 12-il sena, kienu komparabbli ma' dawk f'adulti żgħar f'saħħithom li kienu qed jieħdu doża ta' 1 g ta' ertapenem ġol-vina.
English: Average concentrations of ertapenem in urine exceed 984 micrograms/mL during the period 0 to 2 hours postdose and exceed 52 micrograms/mL during the period 12 to 24 hours post-administration.
Maltese: Il-konċentrazzjonijiet medji ta' ertapenem fl-awrina jaqbżu d-984 mikrogramma/mL fil-perjodu ta' sagħtejn wara d-doża u jaqbżu t-52 mikrogramma/mL fil-perjodu ta' bejn it-12 u l-24 siegħa mid-doża.
English: Plasma concentrations at the midpoint of the dosing interval following a single 15 mg/kg intravenous dose of ertapenem in patients 3 months to 12 years of age are comparable to plasma concentrations at the midpoint of the dosing interval following a 1 g once daily intravenous dose in adults (see Plasma concentrations).
Maltese: Konċentrazzjonijiet tal-plażma f'nofs l-intervall tad-dożaġġ wara doża ewlenija ta' infużjoni ġol-vina ta' 15 mg/kg ta' ertapenem f'pazjenti li kellhom minn 3 xhur sa 12-il sena, huma komparabbli għallkonċentrazzjonijiet tal-plażma f'nofs l-intervall tad-dożaġġ wara doża ewlenija ta' infużjoni ġol-vina ta' 1g kuljum fl-adulti (ara Konċentrazzjonijiet tal-plażma).
English: Ertapenem inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs).
Maltese: M'hemmx għalfejn issir bidla fid-doża għal pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: • Skin redness
Maltese: • għarfien imnaqqas
English: Haemophilus parainfluenzae
Maltese: Effikaċja fi Studji Pedjatriċi
English: There is no accumulation of ertapenem in adults following multiple intravenous doses ranging from 0.5 to 2 g daily.
Maltese: M'hemm l-ebda akkumulazzjoni ta' ertapenem fl-adulti wara dożi multipli mogħtija ġol-vina li jvarjaw minn 0.5 sa 2 g kuljum.
English: Uncommon: Dyspnoea, pharyngeal discomfort Rare: Nasal congestion, cough, epistaxis, rales/rhonchi, wheezing
Maltese: Mhux komuni: Ħruq fis-sit talinfużjoni, ħakk fis-sit talinfużjoni, eritema fis-sit talinfużjoni, eritema fis-sit talinjezzjoni, sħana fis-sit talinfużjoni
English: Proteus vulgaris
Maltese: TAGĦRIF
English: Belgique/België/Belgien MSD Belgium BVBA/SPRL Tél/Tel:+32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: Burkholderia cepacia
Maltese: L-ispeċi Chlamydia
English: Common: Decreases in neutrophil count Uncommon: Increases in platelet count, activated partial thromboplastin time, prothrombin time, decreases in haemoglobin
Maltese: Mhux komuni: Żidiet fl-għadd tal-plejtlets, ħin tattromboplastin parzjali attivat, ħin tal-protrombin, tnaqqis flemoglobina
English: Acinetobacter species
Maltese: • Alluċinazzjonijiet
English: An additional 476 patients received ertapenem as a single 1 g dose prior to surgery in a clinical study for the prophylaxis of surgical site infections following colorectal surgery.
Maltese: Il-kura ma tkomplietx minħabba reazzjonijiet avversi f'1.3% tal-pazjenti. 476 pazjenti oħra ingħataw ertapenem f'doża ewlenija ta' 1g qabel l-operazzjoni fi studju kliniku għal profilassi ta' infezzjonijiet fis-sit taloperazzjoni wara operazzjonijiet fil-kolon u r-rektum.
English: Patients should be informed that dizziness and somnolence have been reported with INVANZ (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu informati li sturdament u ngħas ġew irrapportati b'INVANZ (ara sezzjoni 4.8).
English: Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in healthy young adults (25 to 45 years of age) were 155 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 9 micrograms/mL at 12 hour postdose, and 1 microgram/mL at 24 hour postdose.
Maltese: Konċentrazzjonijiet medji fil-plażma ta' ertapenem wara infużjoni ewlenija fil-vina ta' 1g fuq perjodu ta' 30 minuta f'adulti żgħażagħ f'saħħithom (25 sa 45 sena) kienu ta' 155 mikrogrammi/mL (Cmax)
English: When clinically indicated, a switch to an appropriate oral antibacterial agent may be implemented if clinical improvement has been observed.
Maltese: Meta jkun indikat b'mod kliniku, tista' tiġi implimentata bidla għal sustanza xierqa kontra l-batterji li tingħata mill-ħalq jekk ikun osservat titjib kliniku.
English: Common: Elevation in platelet count
Maltese: Komuni: Żieda fl-għadd talplejtlets
English: • Enterobacterales: S ≤ 0.5 mg/L and R > 0.5 mg/L
Maltese: S≤ 0.5 mg/L u R >0.5 mg/L
English: The safety and efficacy of INVANZ in children below 3 months of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' INVANZ fit-tfal b'età inqas minn 3 xhur ma ġewx determinati s'issa.
English: Batch
Maltese: LOTT
English: Prevention: • Prevention of surgical site infections in adults following surgery of the colon or rectum.
Maltese: • Il-prevenzjoni ta' infezzjonijiet fis-sit tal-operazzjoni fl-adulti wara operazzjoni tal-kolon jew tar-rektum.
English: Based on the data available it cannot be excluded that in the few cases of surgical interventions exceeding 4 hours, patients could be exposed to sub-optimal ertapenem concentrations and consequently to a risk of potential treatment failure.
Maltese: Ibbażat fuq l-informazzjoni disponibbli, ma jistax jiġi eskluż li fil-ftit każijiet ta' interventi kirurġiċi li jaqbżu l-4 sigħat, il-pazjenti jistgħu jiġu esposti għal konċentrazzjonijiet ta' ertapenem li jkunu inqas minn dawk ideali u konsegwentement għal riskju ta' falliment potenzjali tal-kura.
English: • Low blood sugar
Maltese: Health) Limited
English: INVANZ may be used for the treatment of infections in adult patients with mild to moderate renal impairment.
Maltese: INVANZ jista' jintuża għall-kura ta' infezzjonijiet f'pazjenti adulti b'indeboliment ħafif sa moderat talkliewi.
English: • M. catarrhalis: S ≤ 0.5 mg/L and R > 0.5 mg/L
Maltese: S ≤0.5 mg/L u R >0.5 mg/L
English: Rare: Cholecystitis, jaundice, liver disorder
Maltese: Mhux komuni: Dispnea, skonfort tal-farinġi
English: Powder for concentrate for solution for infusion 1 vial
Maltese: U KONTENUT Trab għal konċentrat għal soluzzjoni għall-infużjoni 1 kunjett
English: The reconstituted solution should be diluted in sodium chloride 9 mg/mL (0.9 %) solution immediately after preparation.
Maltese: Is-soluzzjoni rikostitwita għandha tiġi dilwita f'soluzzjoni ta' 9 mg/mL (0.9 %) ta' sodium chloride eżattament wara l-preparazzjoni.
English: Methicillin-resistant staphylococci
Maltese: Staphylococci reżistenti għal methicillin +#
English: Solutions of INVANZ range from colourless to pale yellow.
Maltese: Soluzzjonijiet ta' INVANZ ivarjaw minn bla kulur sa isfar ċar.
English: The plasma clearance (mL/min/kg) of ertapenem in patients 3 months to 12 years of age is approximately 2-fold higher as compared to that in adults.
Maltese: It-tneħħija mill-plażma (mL/min/kg) ta' ertapenem f'pazjenti ta' minn 3 xhur sa 12-il sena hi madwar darbtejn iżjed meta mqabbla ma' dik fladulti.
English: White to off-white powder.
Maltese: - Mard tal-kliewi.
English: Porphyromonas asaccharolytica*
Maltese: Anafilassi inkluż reazzjonijiet anafilaktojd
English: Decreases in valproic acid levels that may fall below the therapeutic range have been reported when valproic acid was co-administered with carbapenem agents.
Maltese: Fl-Unjoni Ewropea ġew irrappurtati ġemgħat lokalizzati ta' infezzjonijiet minħabba organiżmi reżistenti għal carbapenem.
English: Clostridium species (excluding C. difficile)* Eubacterium species*
Maltese: L-ispeċi Clostridium (ħlief C. difficile)* L-ispeċi Eubacterium* L-ispeċi Fusobacterium* L-ispeċi Peptostreptococcus* Porphyromonas asaccharolytica* L-ispeċi Prevotella*
English: Serious anaphylactic reactions require immediate emergency treatment.
Maltese: Reazzjonijiet serji anafilattiċi jeħtieġu kura ta' emerġenza immedjata.
English: For a 50 mL bag of diluent: For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 mL bag of sodium chloride 9 mg/mL (0.9 %) solution; or
Maltese: Għal doża ta' 1 g, ittrasferixxi minnufih il-kontenut tal-kunjett rikostitwit f'borża tal-50 mL ta' 9 mg/mL (0.9%) ta' soluzzjoni ta' sodium chloride, jew
English: A comparison of results show that a 1 g once daily dose of ertapenem achieves a pharmacokinetic profile in patients 13 to 17 years of age comparable to that of adults.
Maltese: Paragun tar-riżultati juri li doża ta' 1 g ta' ertapenem kuljum twettaq profil farmakokinetiku f'pazjenti li għandhom minn 13 sa 17-il sena, li hu komparabbli ma' dak tal-adulti.
English: Acute Pelvic Infections (API) 13 to 17 years
Maltese: Tfal u adolexxenti (3 xhur sa 17-il sena)
English: EMEA/H/C/002419
Maltese: EMA/828392/2011 EMEA/H/C/002419
English: The full EPAR for Desloratadine Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Desloratadine Teva is a ‘generic medicine'.
Maltese: Desloratadine Teva huwa ‘mediċina ġenerika'.
English: Desloratadine Teva is a medicine containing the active substance desloratadine.
Maltese: Desloratadine Teva huwa mediċina li fiha s-sustanza attiva desloratadina.
English: Desloratadine Teva is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Maltese: Desloratadine Teva jintuża biex itaffi s-sintomi tar-rinite allerġika (infjammazzjoni fil-passaġġi nażali kkawżata minn allerġija, pereżempju minn riħ tal-ħuxlief (hay fever) jew allerġija għal akari tat-trab (dust mites) jew urtikarja (kundizzjoni fil-ġilda kkawżata minn allerġija, b'sintomi li jinkludu ħakk u ħorriqija).
English: This is a summary of the European public assessment report (EPAR) for Desloratadine Teva.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Desloratadine Teva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine Teva on 24 November 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Desloratadine Teva fil-24 ta' Novembru 2011.
English: What is Desloratadine Teva?
Maltese: Kif jintuża Desloratadine Teva?
English: The active substance in Desloratadine Teva, desloratadine, is an antihistamine.
Maltese: Is-sustanza attiva f'Desloratadine Teva, id-desloratadina, hija sustanza antistaminika.
English: The recommended dose for adults and adolescents (12 years of age and over) is one tablet once a day.
Maltese: Id-doża rakkomandata għal adulti u adoloxxenti (minn 12-il sena jew aktar) hi 5 mg darba kuljum.
English: What are the benefits and risks of Desloratadine Teva?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Desloratadine Teva?
English: Why has Desloratadine Teva been approved?
Maltese: Għaliex ġie approvat Desloratadine Teva?
English: The CHMP concluded that, in accordance with EU requirements, Desloratadine Teva has been shown to have comparable quality and to be bioequivalent to Aerius.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Dasselta għandu kwalità li tixbah lill-prodott mediċinali bijoekwivalenti Aerius.
English: This means that Desloratadine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
Maltese: Dan ifisser li Desloratadine Teva jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Aerius.
English: Because Desloratadine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Ġaladarba Desloratadine Teva huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Because Desloratadine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Maltese: Billi Desloratadine Teva huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet li jiddeterminaw ilbijoekwivalenza tiegħu mal-mediċina ta' referenza Aerius.
English: 1 bottle Zero days equivalent to titre prior to inactivation (log10)
Maltese: Tiżmim ekwivalenti għal titlu qabel l-inattivazzjoni (log10)
English: EU Number Invented Name
Maltese: Numru ta' l-UE Isem Qawwa
English: Box of type I glass bottle with butyl elastomer closure.
Maltese: Speċi li fuqhom għandu jintuża l prodott
English: This summary was last updated in 04-2013.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'04-2013.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Maltese: Il-vaċċin fih ukoll ‘aġġuvanti' (lidrossidu tal-aluminju u s-saponina) ħalli jtejjeb ir-rispons immunitarju.
English: Zulvac 1 Bovis contains bluetongue virus of one serotype (serotype 1).
Maltese: Zulvac 1 Bovis fih vajrusis tal-lingwablu ta' serotip wieħed (serotip 1).
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni dwar il-bażi tarrakkomandazzjonijiet tas-CVMP, aqra d-diskussjoni xjentifika (parti mill-EPAR ukoll).
English: In 2012 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1 Bovis to convert to normal.
Maltese: Fl-2012 is-CVMP qies li d-dejta mressqa kienet adegwata biex l-awtorizzazzjoni ta' Zulvac 1 Bovis issir normali.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Zulvac 1 Bovis on 05/08/2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea għal Zulvac 1 Bovis fil-05.08.2011.
English: Inactivated vaccine against Bluetongue virus, serotype 1
Maltese: Vaċċin inattivat kontra l-marda tal-vajrus tal-Lingwablu, serotip 1
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 1 Bovis exceed the risks in the prevention of viraemia caused by bluetongue virus, serotype 1 in cattle from two and a half months of age.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) kkonkluda li l-benefiċċji tal-użu ta' Zulvac 1 Bovis jisbqu lir-riskji fil-prevenzjoni tal-viremija kkawżata mis-serotip 1 tal-vajrus tallingwablu fil-bhejjem tal-ifrat minn xahrejn u nofs 'il fuq.
English: Zulvac 1 Bovis is a vaccine.
Maltese: Zulvac 1 Bovis huwa vaċċin.
English: What is the risk associated with ZULVAC 1 Bovis?
Maltese: X'riskji huma assoċjati ma' Zulvac 1 Bovis?
English: The effectiveness of the vaccine was studied in three main laboratory studies in calves where animals were challenged with bluetongue virus serotype 1, after receiving Zulvac 1 Bovis vaccine containing different amounts of virus.
Maltese: L-effikaċja tal-vaċċin ġiet studjata fi tliet studji ewlenin li saru f'laboratorju f'għoġġiela fejn l-annimali ġew infettati bil-vajrus tal-lingwablu ta' serotip 1, wara li ngħataw il-vaċċin Zulvac 1 Bovis li kien fih ammonti differenti tal-vajrus.
English: Why has Zulvac 1 Bovis been approved?
Maltese: Għaliex ġie approvat Zulvac 1 Bovis?
English: What is Zulvac 1 Bovis?
Maltese: X'inhu Zulvac 1 Bovis?
English: Zulvac 1 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges .
Maltese: Zulvac 1 Ovis jintuża fil-bhejjem tal-ifrat biex jipproteġihom kontra l-marda tal-lingwablu, li hija infezzjoni kkawżata mill-vajrus tal-lingwablu li jiġi trażmess mill-insetti dipteri.
English: How has Zulvac 1 Bovis been studied?
Maltese: Kif ġie studjat Zulvac 1 Bovis?
English: Protection starts two weeks after the last injection and lasts for a year.
Maltese: Il-protezzjoni tibda taħdem ġimagħtejn wara l-għoti tal-aħħar injezzjoni u ddum sena.
English: EU/1/15/1061/001 EU/1/15/1061/002
Maltese: EU/1/15/1061/002
English: Age, gender, and ethnicity
Maltese: Età, sess, u l-etniċità
English: • corticosteroids including:
Maltese: • kortikosterojdi inklużi:
English: IMMUNOSUPPRESSANTS Ciclosporin
Maltese: IMMUNOSOPPRESSANTI Ciclosporin
English: ATC code: J05AR18.
Maltese: J05AR18.