FrancophonIA/ELRC3.0 huggingface dataset:
English: 29, avenue Tony Garnier 69007 Lyon
Maltese: 29 avenue Tony Garnier 69007 Lyon FRANCE
English: 06861 Dessau-Rosslau Germany
Maltese: 06861 Dessau-Rosslau Ġermanja
English: Pharmacotherapeutic group:
Maltese: Grupp Farmako-terapewtiku:
English: Carbomer 971 P NF Thiomersal
Maltese: Carbomer 971 P NF Tiomersal
English: Onset of immunity:
Maltese: Tul tal-immunità:
English: EU/2/09/102/003 EU/2/09/102/006
Maltese: EU/2/09/102/006
English: Store in a refrigerator (2 ºC − 8 ºC).
Maltese: Aħżen fil-friġġ (2°C - 8°C ).
English: Adverse reactions (frequency and seriousness)
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravità)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Maltese: - 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: GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine.
Maltese: GMNU = Geometric mean of neutralizing units immunizzazzjoni indotta fil-fenek ta' l-indi wara ttieni tilqima ta' 0.5 ml b' dan il-vaċċin.
English: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany
Maltese: Pharmapark 06861 Dessau-Rosslau Ġermanja
English: Contraindications
Maltese: INDIKAZZJONIJIET
English: Incompatibilities
Maltese: .2 Inkompatibilitajiet
English: 100 ml (50 doses)
Maltese: 50 ml (25 doża)
English: Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2)
Maltese: Strejns tal-virus inattivat ta' l-influwenza A/ ħnieżer/ Bakum/IDT1769/2003 (H3N2)
English: 20 ml (10 doses), 50 ml (25 doses), 100 ml (50 doses)
Maltese: DAQS TAL-PAKKETT 20 ml (10 dożi), 50 ml (25 doża), 100 ml (50 doża)
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manufattur tas-sustanza bioloġika attiva
English: Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log2 GMNU, Haselünne/IDT2617/2003(H1N1) ≥ 10.22 log2 GMNU, Bakum/1832/2000 (H1N2) ≥ 12.34 log2 GMNU
Maltese: Strejns tal-virus inattivat ta' l-influwenza A/ ħnieżer/ Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log2 GMNU Haselünne/IDT2617/2003 (H1N1) ≥ 10.
English: PET vials: 20 ml Polyethylene terephthalate (PET) vials, clear 50 ml PET vials, clear
Maltese: Kunjetti tal-polyethylene terephthalate (PET) ta' 20 ml, trasparenti Kunjetti PET ta' 100 ml, trasparenti
English: Glass vials: 20 ml vials, glass type I 50 ml vials, glass type II 100 ml vials, glass type II
Maltese: Kunjetti tal-ħġieġ: kunjetti ta' 20 ml, ħġieġ tat-tip 1 kunjetti ta' 50 ml, ħġieġ tat-tip II kunjetti ta' 100 ml, ħġieġ tat-tip II
English: Date of first authorisation: 14/01/2010 Date of last renewal : DD/MM/YYYY
Maltese: Data tal-aħħar tiġdid:(DD/MM/YYYY)
English: Protect from light.
Maltese: KONTRAINDIKAZZJONIJIET Xejn.
English: Bromobutyl rubber stoppers
Maltese: Tappijiet tal-lastku Bromobutyl
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor
English: Manufacturer responsible for batch release: IDT Biologika GmbH Am Pharmapark
Maltese: IDT Biologika GmbH Am
English: Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn
English: The vaccine stimulates an active immunity against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Maltese: It-tilqima tqanqal immunità attiva kontra s-sottotipi H1N1, H3N2 u H1N2 tal-virus tal-Influwenza A tal-ħnieżer.
English: 29 avenue Tony Garnier 69007 Lyon,
Maltese: 69007 Lyon,
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U L-MANIFATTUR RESPONSABBLI
English: STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TA' L-MRLs
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for 20ml, 50 ml, 100 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun ta' 20ml, 50 ml, 100 ml
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination (“very rare” corresponds to a frequency of adverse reactions less than 1 animal in 10,000 animals, including isolated reports).
Maltese: F'każijiet rari ħafna , jista' jkun hemm żieda żgħira momentarja fit-temperatura tar-rektum wara t-tilqima.(“ rari ħafna” tikkorrispondi għal frekwenza ta' effetti mhux mixtieqa inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Caps:
Maltese: Drafeġ:
English: Intramuscular use.
Maltese: Mhux applikabbli
English: Veterinary medicinal product subject to prescription
Maltese: TAL-PRODOTT MEDIĊINALI
English: Package sizes:
Maltese: Daqsijiet tal-pakketti:
English: Pigs
Maltese: U LUŻU
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 tas-Sommarju tal-karatteristiċi tal-prodott huma jew sustanzi ammissibbli li tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 tindika li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: Immunologicals, Inactivated viral vaccines
Maltese: Immunologiċi, vaċċini li fihom virusijiet inattivati Kodici ATĊ veterinarja:
English: Piglets:
Maltese: Għotjien:
English: After administration of a double dose (4 ml), no adverse reactions other than those described in section 4.6 were observed.
Maltese: Wara li ngħatat doża doppja tat-tilqima (4 ml), l-ebda reazzjoni avversa, ħlief dawk imsemmiija fissezzjoni 4.6, ma ntweriet.
English: Strains of inactivated Influenza A virus/swine (H3N2) ≥ 10.53 log2 GMNU, (H1N1) ≥ 10.22 log2 GMNU, (H1N2) ≥ 12.34 log2 GMNU
Maltese: 22 log2 GMNU, (H1N2) ≥ 12.34 log2 GMNU
English: Generally, maternallyderived antibodies induced by vaccination last for approx. 5-8 weeks after birth.
Maltese: Ġeneralment, l-antikorpi derivati mill-omm indotti mit-tilqim idumu bejn wieħed u ieħor minn 5 sa 8 ġimgħat wara t-twelid.
English: When vaccination is performed 14 days prior to farrowing with one dose (2 ml), it provides maternally-derived immunity to the piglets which protects them from clinical signs of influenza at least until day 33 after birth.
Maltese: (2 ml), dan jipprovdi immunità derivata mill-omm lid-drafeġ li tipproteġihom minn sinjali kliniċi tal-influwenza tal-inqas sat-33 jum wara t-twelid.
English: CLINICAL PARTICULARS 4.1.
Maltese: ANNESS II A.
English: Gripovac 3 Suspension for injection for pigs
Maltese: VETERINARJU Gripovac 3 suspensjoni għall-injezzjoni għall-ħnieżer.
English: Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.
Maltese: Tul tal-immunità: 4 xhur fi ħnieżer imlaqqmin bejn l-età ta' 56 u 96 jum u 6 xhur fi ħnieżer imlaqqmin għall-ewwel darba ta' 96 jum u 'l fuq.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: 3 DIKJARAZZJONI TAS-SUSTANZA(I)
English: PHARMACEUTICAL PARTICULARS 6.1.
Maltese: 6.1 Lista ta' ingredjenti
English: Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.
Maltese: Immunizzazzjoni attiva tal-ħnieżer mill-età ta' 56 ġurnata 'l fuq inklużi majjaliet fit-tqala kontra linfluwenza tal-ħnieżer ikkawżata mis-sottotipi H1N1, H3N2 u H1N2 biex tnaqqas is-sinjali kliniċi u lammont ta' virus fil-pulmun wara infezzjoni.
English: or - Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.
Maltese: jew - Bejn l-età ta'56 u 96 jum, b'intervall ta' 3 ġimgħat bejn injezzjoni u oħra biex jinkiseb tul ta'
English: When a single dose of the vaccine is administered 14 days prior to farrowing as a booster to previously vaccinated sows, the vaccine stimulates active immunity in order to provide maternally-derived immunity to the progeny against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Maltese: Meta bħala ‘booster' tiġi amministrata doża waħda tal-vaċċin 14-il ġurnata qabel li l-majjala li kienet diġa mlaqqma tferragħ, il-vaċċin jistimola immunità attiva biex tipprovdi immunità derivata mill-omm liż-żgħar kontra s-sottotipi H1N1, H3N2 u H1N2 tal-virus talInfluwenza A tal ħnieżer.
English: Gilts and sows:
Maltese: Sustanza mhux attiva:
English: It induces neutralizing and haemagglutination inhibiting antibodies against each of the three subtypes.
Maltese: Tinduċi antikorpi li huma newtralizzanti u li jinibixxu l-agglutinazzjoni tad-demm kontra kull wieħed tat-tliet sottotipi.
English: IM Read the package leaflet before use.
Maltese: PROJBIZZJONI TA' BEJGĦ, PROVISTA, U/JEW UŻU Mhux Applikabbli.
English: Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth.
Maltese: Immunizzazzjoni attiva ta' majjaliet fit-tqala wara t-tmiem ta' l-ewwel immunizzazzjoni b'doża waħda 14-il ġurnata qabel it-twellid biex tiġi żviluppata immunità għolja tal-kolostrum li tipprovdi protezzjoni klinika tad-drafeġ tal-anqas għal 33 ġurnata wara li jitwieldu.
English: PACKAGE LEAFLET FOR:
Maltese: Żmien ta' Tiżmim:
English: Gripovac 3 suspension for injection for pigs
Maltese: Gripovac 3 Suspensjoni għall-injezzjoni għall-ħnieżer.
English: Cardboard box with 1 PET vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.
Maltese: Kaxxa tal-kartun b'kunjett PET ta' 10 dożi (20 ml), 25 doża (50 ml) jew 50 doża (100 ml) b'tapp tallastku u għatu bi flanġa.
English: Shelf-life
Maltese: TAGĦRIF
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju jew lill-ispiżjar tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Maternally-derived immunity in the piglets interacts with antibody induction.
Maltese: L-immunità derivata mill-omm fid-drafeġ taġixxi reċiprokament mall-inizzjazzjoni tal-antikorpi.
English: A transient slight swelling may occur on very rare occasions after vaccination at the site of injection, regressing within 2 days.
Maltese: Wara li tingħata t-tilqima, f'każijiet rari ħafna, jista jkun hemm nefħa lokali ħafifa u momentarja li tinżel fi żmien jumejn.
English: Flanged caps
Maltese: għotjien bi flanġa
English: Disposal: read package leaflet
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva, peress li hija kostitwent ta' oriġini bioloġika intiża biex tipproduċi immunità attiva, mhiex fl-iskop tar-Regolament tal-Kunsill (KE) 470/2009.
English: Stoppers:
Maltese: Tappijiet:
English: The full EPAR for IntronA 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: In adults, the most common side effects with IntronA used with or without ribavirin (seen in more than 1 patient in 10) are pharyngitis (sore throat), viral infection, leucopenia (low white blood cell counts), loss of appetite, depression, insomnia (difficulty sleeping), anxiety, emotional lability (mood swings), agitation, nervousness, dizziness, headache, impaired concentration, dry mouth, blurred vision, dyspnoea (difficulty breathing), coughing, nausea (feeling sick) or vomiting, abdominal pain (stomach ache), diarrhoea, stomatitis (inflammation of the lining of the mouth), dyspepsia (heartburn), alopecia (hair loss), pruritus (itching), dry skin, rash, increased sweating, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection including inflammation, fatigue (tiredness), rigors (shaking chills), pyrexia (fever), flu-like symptoms, asthenia (weakness), irritability, chest pain, malaise (feeling unwell) and weight loss.
Maltese: Fl-adulti, l-effetti sekondarji l-aktar komuni b'IntronA użat flimkien ma' ribavirin jew mingħajru (li dehru f'aktar minn pazjent 1 minn 10) huma farinġite (griżmejn misluħa), infezzjoni virali, lewkopenija (rata baxxa ta' ċelloli bojod fid-demm), nuqqas ta' aptit, depressjoni, insomnja (diffikultà fl-irqad), ansjetà, bidla fil-burdata, aġitazzjoni, nervożiżmu, sturdament, uġigħ ta' ras, konċentrazzjoni mnaqqsa, ħalq niexef, vista mċajpra, dispnea (diffikultà fin-nifs), sogħla, nawżja (tħossok ma tiflaħx) jew remettar, uġigħ addominali (uġigħ fl-istonku), diareja, stomatite (infjammazzjoni tar-rita tal-ħalq), dispepsija (indiġestjoni), alopeċja (telf ta' xagħar), prurite (ħakk), ġilda xotta, raxx, żieda fl-għaraq, mijalġja (uġigħ fil-muskoli), artralġja (uġigħ fil-ġogi), uġigħ muskuloskeletali (uġigħ fil-muskoli u flgħadam), reazzjonijiet fis-sit tal-injezzjoni inkluż infjammazzjoni, għeja, rigors (rogħda qawwija bilbard), piressija (deni), sintomi simili għal tal-influwenza, astenja (djgħufija), irritabilità uġiegħ fis-sider, malaise (meta wieħed iħossu ħażin) u telf fil-piż.
English: These contain between 1 and 50 million international units (IU) per millilitre.
Maltese: Dawn fihom minn 1 sa 50 miljun unitajiet internazzjonali (UI) kull millilitru.
English: It is usually used in combination with ribavirin (an antiviral medicine);
Maltese: Normalment jintuża flimkien ma' ribavirin (mediċina antivirali);
English: • carcinoid tumour (a tumour of the endocrine system that produces hormones);
Maltese: • tumur karċinojdu (tumur tas-sistema endokrinali li tipproduċi l-ormoni);
English: EPAR summary for the public interferon alfa 2b
Maltese: Sommarju tal-EPAR għall-pubbliku interferon alfa-2b
English: The active substance in IntronA, interferon alfa-2b, belongs to the group ‘interferons'.
Maltese: Is-sustanza attiva f'IntronA, interferon alfa-2b, hija parti mill-grupp ta' ‘interferoni'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for IntronA on 9 March 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal IntronA fid-9 ta' Marzu 2000.
English: The interferon alfa-2b in IntronA is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Maltese: L-interferon alfa-2a f'IntronA huwa prodott permezz ta' metodu magħruf bħala “teknoloġija rikombinanti tad-DNA”: jiġifieri jinkiseb minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi jipproduċi l-interferon alfa-2b.
English: What is the risk associated with IntronA?
Maltese: X'inhu r-riskju assoċjat ma' IntronA?
English: This is a summary of the European public assessment report (EPAR) for IntronA.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal IntronA.
English: IntronA is a medicine that contains the active substance interferon alfa-2b.
Maltese: IntronA huwa mediċina li fih is-sustanza attiva interferon alfa-2b.
English: IntronA is used as an add-on to anticancer treatments;
Maltese: IntronA jintuża bħala addizzjoni mat-trattamenti kontra l-kanċer;
English: Why has IntronA been approved?
Maltese: Għaliex ġiet approvat IntronA?
English: • follicular lymphoma (a cancer of the lymph tissue).
Maltese: • limfoma follikulari (kanċer tat-tessut limfatiku).
English: • long-term hepatitis B (a disease of the liver due to infection with the hepatitis B virus) in adults (aged 18 years and older);
Maltese: • epatite B fit-tul (marda tal-fwied minħabba infezzjoni bil-vajrus tal-epatite B) fl-adulti (minn 18-il sena 'l fuq);
English: • malignant melanoma (a type of skin cancer affecting cells called melanocytes).
Maltese: • melanoma malinja (tip ta' kanċer tal-ġilda li jaffettwa ċ-ċelloli msejħa melanocytes).
English: What is IntronA?
Maltese: X'inhu IntronA?
English: • chronic myelogenous leukaemia (CML, a cancer of the white blood cells) in adults.
Maltese: • lewkimja mjeloġena kronika (CML, kanċer taċ-ċelloli bojod tad-demm) fl-adulti.
English: IntronA is used to maintain anticancer effects in patients who have responded to previous treatment with anticancer medicines;
Maltese: IntronA jintuża bħala terapija ta' manutenzjoni kontra lkanċer f'pazjenti li rrispondew għal trattament preċedenti b'mediċini kontra l-kanċer;
English: In children and adolescents receiving IntronA in combination with ribavirin, side effects were similar to adults, although anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), hypothyroidism (underactive thyroid gland) and reduced growth were also seen in more than 1 patient in 10.
Maltese: Fit-tfal u fl-adoloxxenti li rċevew IntronA flimkien ma' ribavirin, l-effetti sekondarji kienu simili għal dawk tal-adulti, għalkemm anemija (għadd baxx ta' ċelloli tad-demm ħomor), newtropenja (livelli baxxi ta' newtrofili, tip ta' ċelloli bojod tad-demm), ipotrojdiżmu (glandola tat-tirojde mhux attiva biżżejjed) u tnaqqis fit-tkabbir intwerew ukoll f'iktar minn pazjent 1 minn kull 10.
English: IntronA can be used in combination with cytarabine (an anticancer medicine) in the first year;
Maltese: IntronA jista' jintuża flimkien ma' cytarabine (mediċina kontra l-kanċer) fl-ewwel sena;
English: This summary was last updated in 12-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'12-2011.
English: Interferon alfa-2b has been available in the European Union (EU) for the treatment of various diseases for a number of years.
Maltese: L-interferon alfa-2b ilu disponibbli fl-Unjoni Ewropea (UE) għall-kura ta' diversi mard għal numru ta' snin.
English: The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.
Maltese: L-interferon alfa-2b li jissostitwixxi jaġixxi bl-istess mod bħal interferon alfa li jiġi prodott b'mod naturali.
English: IntronA is used after surgery in patients whose melanoma could come back.
Maltese: IntronA jintuża wara l-kirurġija fuq pazjenti li l-melanoma tagħhom tista' terġa titfaċċa.
English: The dose and duration of treatment depend on the disease being treated and the response of the patient, with doses ranging from 2 to 20 million IU per square metre of body surface area (calculated using the patient's height and weight).
Maltese: Id-doża u t-tul tat-trattament jiddependu mill-marda li qed tiġi trattata u r-reazzjoni tal-pazjent, b'dożi li jvarjaw minn 2 sa 20 miljun UI kull metru kwadru tas-superfiċje tal-ġisem (ikkalkolati skont it-tul u l-piż talpazjent).
English: IntronA is generally given three times per week but the injection can be given more frequently in CML and melanoma.
Maltese: IntronA jingħata tliet darbiet fil-ġimgħa iżda l-injezzjoni tista' tingħata b'mod iktar frekwenti fir-rigward ta' CML u melanoma.
English: Other information about IntronA
Maltese: Għalxiex jintuża IntronA?
English: • multiple myeloma (a cancer of the bone marrow).
Maltese: • mjeloma multipla (kanċer tal-mudullun).
English: Because interferon alfa 2b has been used in the EU for a number of years, the company presented the results of studies from the published literature, as well as from studies of its use with cytarabine in CML and studies of IntronA used alone (in adults) or with ribavirin (in patients from three years of age) for the treatment of long-term hepatitis C. The main measures of effectiveness were the number of patients who responded to treatment in the hepatitis studies and how long the patients survived in the cancer studies.
Maltese: Minħabba li l-interferon alfa-2b ilha tintuża fl-UE għal numru ta' snin, il-kumpanija ppreżentat irriżultati tal-istudji minn dokumentazzjoni ppubblikata, kif ukoll minn studji dwar l-użu tagħha ma' cytarabine f'CML u studji ta' IntronA użat waħdu (fl-adulti) jew ma' ribavirin (f'pazjenti minn 3 snin 'il fuq) għat-trattament ta' tal-epatite Ċ fit-tul.
English: How has IntronA been studied?
Maltese: Kif ġie studjat IntronA?
English: Further information on Truvada 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: Other information about Truvada
Maltese: Informazzjoni oħra dwar Truvada
English: This overview was last updated in 02-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi 02-2018.
English: Truvada is available as tablets.
Maltese: Truvada jiġi bħala pilloli.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Maltese: Tenofovir huwa inibitur nukleotidiku tat-traskriptażi inversa.
English: Truvada contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Maltese: Truvada fih żewġ sustanzi attivi, l-emtriċitabina (200 mg) u t-tenofovir disoprossil (245 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Truvada on 21 February 2005.
Maltese: Truvada rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fil-21 ta' Frar 2005.
English: The second study examined the effects of emtricitabine and tenofovir disoproxil, taken with lopinavir and ritonavir (other antiviral medicines) in 196 patients with HIV-1 infection.
Maltese: It-tieni studju eżamina l-effetti tal-emtriċitabina u tat-tenofovir disoprossil, meħudin ma' lopinavir u ritonavir (mediċini antivirali oħra) f'196 pazjent b'infezzjoni tal-HIV-1.
English: What are the risks associated with Truvada?
Maltese: X'inhuma r-riskji assoċjati ma' Truvada?
English: When the active substances emtricitabine or tenofovir are given separately, the most common side effects (seen in more than 1 patient in 10) also include hypophosphataemia (low levels of phosphates in the blood), headache, dizziness, vomiting, rash, weakness and raised blood levels of creatine kinase (an enzyme found in muscles).
Maltese: Meta s-sustanzi attivi l-emtriċitabina jew it-tenofovir jingħataw separatament, l-effetti sekondarji l-aktar komuni (li dehru f'aktar minn pazjent 1 minn kull 10) jinkludu wkoll ipofosfatemija (livelli baxxi ta' fosfati fid-demm), uġigħ ta' ras, sturdament, rimettar, raxx, dgħufija u livelli ta' demm miżjuda ta' kinażi tal-kreatina (enzima li tinsab fil-muskoli).