FrancophonIA/ELRC3.0 huggingface dataset:
English: Having considered all data submitted in writing and in the oral explanation provided by the applicant the CVMP concluded that the available data are adequate to support the efficacy of Nuflor 300 mg/ml solution for injection for cattle and sheep at the dose of 20 mg/kg daily via the intramuscular route of administration for three consecutive days in the treatment of Ovine Respiratory Disease associated with M. haemolytica and P. multocida.
Maltese: Wara li kkunsidra d-dejta kollha ppreżentata bil-miktub u fl-ispjegazzjoni orali pprovduta millapplikant, is-CVMP ikkonkluda li d-dejta disponibbli hija adegwata sabiex tappoġġja l-effikaċja ta' Nuflor 300 mg/ml soluzzjoni għall-injezzjoni għall-frat u n-nagħaġ fid-doża ta' 20 mg/kg kuljum mogħti ġol-muskolu għal tlett ijiem konsekuttivi fil-kura ta' Mard Respiratorju tan-Nagħaġ assoċjat ma' M. haemolytica u P. multocida.
English: (Clinical breakpoint is a MIC value used by clinicians to classify bacteria as susceptible or resistant to a certain antimicrobial and is therefore a measure of clinical efficacy.)
Maltese: (Il-valur tal-limitu kliniku huwa valur MIC użat mit-tobba sabiex jikklassifikaw il-batterji bħala suxxettibbli jew reżistenti għal antimikrobjali partikolari u għalhekk huwa kejl ta' effikaċja klinika.)
English: • Based on data generated in the pivotal pharmacokinetic study, intramuscular administration of the proposed recommended treatment dose resulted in mean peak serum concentrations of ~9 - 10 μg/ml by approximately 1 hour after treatment.
Maltese: • Abbażi ta' dejta ġġenerata fl-istudju farmakokinetiku pivotali, l-għoti ġol-muskolu tad-doża tal-kura rakkomandata proposta wassal għal konċentrazzjonijiet medji massimi fis-serum ta' ~9 - 10 μg/ml sa madwar siegħa wara l-kura.
English: Germany
Maltese: Germanja
English: There appears to be no advantage to increasing the dose to 30 mg/kg.
Maltese: Jidher li m'hemm l-ebda vantaġġ jekk id-doża tiżdied għal 30 mg/kg.
English: Having considered all data submitted in writing and in the oral explanation the CVMP concluded that:
Maltese: Wara li kkunsidra d-dejta kollha ppreżentata bil-miktub u fl-ispjegazzjoni orali, is-CVMP ikkonkluda li:
English: There was a concern that a dose of 20 mg florfenicol/kg administered intramuscularly every 24 hours would not maintain an active/effective concentration of florfenicol at the infection site for the between treatment interval (that is, 24 hours).
Maltese: Kien hemm tħassib li doża ta' 20 mg florfenicol/kg mogħtija fil-muskolu kull 24 siegħa ma żżommx konċentrazzjoni attiva/effettiva ta' florfenicol fil-post tal-infezzjoni għall-intervall ta' bejn il-kura (jiġifieri, 24 siegħa).
English: During the procedure the applicant provided additional data and the issues raised by France regarding the proposed indications were resolved.
Maltese: Waqt din il-proċedura, l-applikant ipprovda dejta addizzjonali u lkwisjtonijiet imqajma minn Franza rigward l-indikazzjonijiet proposti ġew solvuti.
English: • The proposed dosing schedule is supported by a dose finding study using an experimental model of respiratory disease where test animals were challenged with Mannheimia haemolytica, and
Maltese: • L-iskeda ta' dożaġġ proposta hija appoġġata minn studju ta' individwazzjoni tad-doża li juża mudell sperimentali ta' mard respiratorju fejn l-annimali ttestjati ġew injettati b'Mannheimia haemolytica, u
English: Ireland
Maltese: Irelanda
English: The preclinical data provided support the recommended treatment interval (24 hours) for target pathogens with MIC up to 1 μg/ml.
Maltese: Data pre-kliniċi jipprovdu appoġġ tal-intervall rakokomandat fit-trattament (24 siegħa) għall-patoġeni mirab' MIC sa 1 μg/ml.
English: Based on the findings of the field study, the applicant concluded that based on the primary efficacy parameter - treatment failure rates, Nuflor can be considered superior (at Day 4) or non-inferior (at Day 11) to the positive control product containing 100 mg/ml oxytetracycline, when used for the treatment of respiratory disease in sheep associated with either M. haemolytica or P. multocida.
Maltese: Abbażi tas-sejbiet tal-istudju fuq il-post, l-applikant ikkonkluda li skont il-parametru taleffikaċja primarja - ir-rati ta' falliment tal-kura, Nuflor jista' jitqies superjuri (f'Jum 4) jew mhux inferjuri (f'Jum 11) għall-prodott ta' kontroll pożittiv li fih 100 mg/ml oxytetracycline, meta jintuża għall-kura ta' mard respiratorju fin-nagħaġ assoċjat kemm ma' M. haemolytica kif ukoll P. multocida.
English: Thus, florfenicol behaves essentially like a bactericidal time dependant antibiotic.
Maltese: B'hekk, florfenicol jaħdem essenzjalment bħala antibijotiku batteriċida li jiddependi mill-ħin.
English: The results of this study demonstrated that florfenicol administered once daily at a dose of either 10, 20 or 30 mg/kg was effective for the treatment of pneumonia in sheep induced by M. haemolytica.
Maltese: Ir-riżultati ta' dan l-istudju urew li florfenicol mogħti darba kuljum f'doża ta' 10, 20 jew 30mg/kg kien effettiv għall-kura ta' pulmonite fin-nagħaġ ikkawżata minnM. haemolytica.
English: From the M. haemolytica data, it can be seen that time to achieve a 3-Log reduction decreased with increasing florfenicol concentration; and, after only two hours exposure, florfenicol exhibits a post-antibiotic effect (ranging from 1 - 3 hours at concentrations >1 μg/ml).
Maltese: Mid-dejta dwar l-M. haemolytica, jidher li l-ħin sabiex jinkiseb tnaqqis ta' 3-Log naqas maż-żieda tal-konċentrazzjoni ta' florfenicol; u, wara biss sagħtejn espożizzjoni, florfenicol juri effett post-antibijotiku (li jvarja minn 13 sigħat f'konċentrazzjonijiet >1 μg/ml).
English: For the objecting Member State, this gave rise to concerns that there was the potential for underdosing and that there may be an increase in risk for development of florfenicol resistance.
Maltese: Għall-Istat Membru li oġġezzjona, dan wassal għal tħassib li kien hemm il-potenzjal ta' dożaġġ nieqes u li jista' jkun hemm żieda fir-riskju ta' żvilupp ta' reżistenza għal florfenicol.
English: Dose finding study
Maltese: Valutazzjoni tad-dejta ppreżentata
English: Pharmaceutical form Strength Animal species Route of administration
Maltese: Għamla farmaċewtika
English: • The following can be concluded from the pharmacodynamic data presented: florfenicol has a pronounced bactericidal effect with Minimum Bactericidal Concentration (MBC) values the same, or one dilution higher, than the MIC of the tested strains.
Maltese: • Dan li ġej jista' jiġi konkluż mid-dejta farmakodinamika ppreżentata: florfenicol għandu effett batteriċida qawwi b'valuri ta' Konċentrazzjoni Batteriċida Minima (MBC) l-istess bħal, jew dilwizzjoni ogħla, mill-MIC tar-razez ittestjati.
English: Add the following text in the relevant sections of the product information:
Maltese: Żid it-test li ġej fis-sezzjonijiet relevanti fl-informazzjoni talprodott:
English: • Although some concentration dependency trends were observed for M. haemolytica strains, the killing effect/kinetic does not increase dramatically with the concentration of the antibiotic over the MIC or twice the MIC.
Maltese: • Għalkemm ġew osservati xi tendenzi ta' dipendenza mill-konċentrazzjoni għar-razez ta' M. haemolytica, l-effett ta' qtil/kinetika ma jiżdiedx b'mod drammatiku mal-konċentrazzjoni talantibijotiku fuq l-MIC jew darbtejn l-MIC.
English: Mean florfenicol concentration in serum remained above 1 μg/ml (MIC90) for up to 18 hours following administration of the product at the recommended treatment dose.
Maltese: Il-konċentrazzjoni medja ta' florfenicol fis-serum baqgħet ogħla minn 1 μg/ml (MIC90) sa 18-il siegħa wara l-għoti tal-prodott fid-doża tal-kura rakkomandata.
English: The overall conclusion is that the efficacy dataset as a whole is adequate to support the efficacy of Nuflor 300 mg/ml solution for injection for cattle and sheep at the dose of 20 mg/kg daily via the intramuscular route of administration for three consecutive days in the treatment of Ovine Respiratory Disease associated with M. haemolytica and P. multocida.
Maltese: Il-konklużjoni globali hija li s-sett ta' dejta globali dwar l-effikaċja huwa adegwat bħala appoġġ għalleffikaċja ta' Nuflor 300 mg/ml soluzzjoni għall-injezzjoni għall-frat u n-nagħaġ fid-doża ta' 20 mg/kg kuljum mogħti minn ġol-muskolu għal tlett ijiem konsekuttivi fil-kura ta' Mard Respiratorju tan-Nagħaġ assoċjat ma' M. haemolytica u P. multocida.
English: The study was conducted at multiple sites in Germany and Spain.
Maltese: L-istudju sar f'diversi postijiet fil-Ġermanja u fi Spanja.
English: For referral procedures: Please refer to the guidance in the annotated QRD template for centralised procedures.]
Maltese: [*For the printed material, please refer to the guidance of the annotated QRD template.]
English: <ANNEX III> [For referral procedures]
Maltese: <ANNESS III> [For referral procedures]
English: {Name}
Maltese: {Isem}
English: <Fertility>
Maltese: <Fertilità>
English: <...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...>
Maltese: <…> <6 xhur> <…> <sena> <18-il xahar> <sentejn> <30 xahar> <3 snin> <…>
English: <Pharmacodynamic effects>
Maltese: <Effetti farmakodinamiċi>
English: <Environmental Risk Assessment (ERA)>
Maltese: < Rapport ta' Stima tar-Riskju Ambjentali (ERA) >
English: <{(Invented) Name} is a biosimilar medicinal product.
Maltese: <{(Isem Ivvintat)} hu prodott mediċinali bijoloġiku simili.
English: <Distribution>
Maltese: <Distribuzzjoni>
English: <Clinical efficacy and safety>
Maltese: <Effikaċja klinika u sigurtà>
English: <Linearity/non-linearity>
Maltese: < Linearità/nuqqas ta' linearità>
English: Do not <take> <use> X<:>
Maltese: <Tiħux> <Tużax> X <:>
English: X with <food> <and> <,> <drink> <and> <alcohol>
Maltese: X ma' <ikel> <u> <,> <xorb> <u> <alkoħol>
English: <Elimination>
Maltese: <Eliminazzjoni>
English: <[See Annex I - To be completed nationally]> [For referral procedures, as appropriate]
Maltese: <[Ara Anness I - Biex timtela mill-pajjiż partikolari]> [For referral procedures, as appropriate]
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc" Appendix V.*
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f' HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc" Appendiċi V*.
English: <Pharmacokinetic/pharmacodynamic relationship(s)>
Maltese: <Relazzjoni(jiet) farmakokinetika(ċi)/farmakodinamika(ċi)>
English: <Not relevant.>
Maltese: <Mhux rilevanti.>
English: Pregnancy <and> <,> breast-feeding <and fertility>
Maltese: Tqala <u> <,> treddigħ <u fertilità>
English: <No data are available.> <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Maltese: <Dejta mhux disponibbli> <Dejta disponibbli hi deskritta fis-sezzjoni <4.8> <5.1> <5.2> imma
English: The active substance(s) is (are)…
Maltese: - Is-sustanza(i) attiva(i) hi (huma) .....
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]>
Maltese: {numru} [numru tar-rimborż nazzjonali jew numru nazzjonali tal-identifikazzjoni għall-prodott mediċinali]>
English: <For the full list of excipients, see section 6.1.>
Maltese: <Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.>
English: <Absorption>
Maltese: <Assorbiment>
English: Package leaflet: Information for the <patient> <user>
Maltese: Informazzjoni għall-<pazjent> <utent>
English: The other <ingredient(s)> <(excipient(s))> is (are)...
Maltese: - <Is-sustanza(i)> l-oħra <(eċċipjent(i))>hi (huma) ....
English: <{DD/MM/YYYY}>
Maltese: <{XX/SSSS}>
English: Children <and adolescents>
Maltese: Tfal <u adolexxenti>
English: DOSIMETRY>
Maltese: DOŻIMETRIJA>
English: <The recommended dose is...>
Maltese: <Id-doża rakkomandata hija…>
English: Pharmacotherapeutic group: {group}, ATC code: {code} <not yet assigned>
Maltese: {kategorija}, Kodiċi ATC:
English: <Additional side effects in children <and adolescents>>
Maltese: <Effetti sekondarji addizzjonali fit-tfal <u l-adolexxenti>>
English: <Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:>
Maltese: <Ma dehrux effetti mhux mixtieqa waqt studji kliniċi, iżda dehru f'annimali f'livelli ta' esponiment simili għal livelli ta' esponiment kliniku u b'rilevanza possibbli għall-użu kliniku, kif spjegat:>
English: <Date of first authorisation: {DD month YYYY}>
Maltese: <Data tal-aħħar tiġdid: {JJ xahar SSSS}>
English: <{X} is contraindicated in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...> (see section 4.3).>
Maltese: <{X} hu kontra-indikat <fit-tfal minn eta` {x sa y} <snin> <xhur> {jew xi kategoriji rilevanti oħra eż: piż, eta` tal-pubertà, sess} < għal indikazzjoni ta'.....> (ara sezzjoni 4.3)>
English: <Breastfeeding>
Maltese: <Treddigħ>
English: <Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 <or {name of the residue(s)}>.>
Maltese: <Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 <jew {l-isem tar-residwu(i)}>.>
English: <Biotransformation>
Maltese: <Bijotrasformazzjoni>
English: < PC: {number} [product code]
Maltese: < PC:
English: <Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.>
Maltese: <Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.>
English: <{Name of the Member State}> <{Name of the medicinal product}>
Maltese: <{Isem ta' l-Istat Membru}><{Isem tal-prodott mediċinali}>
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS>
Maltese: STRUZZJONIJIET GĦALL-PREPARAZZJONI TA' PRODOTTI RADJUFARMAĊEWTIĊI>
English: <The <safety> <and> <efficacy> of {X} in children aged {x to y} <months> <years> [or any other relevant subsets, e.g. weight, pubertal age, gender] <has> <have> not <yet> been established.>
Maltese: <<Is-sigurtà> <u> <l-effikaċja> ta' {X} fit-tfal minn eta` {x sa y} <snin> <xhur> {jew xi kategoriji rilevanti oћra eż: piż, eta` tal-pubertà, sess} <ġew> <ma ġewx> determinati s'issa.>
English: <The European Medicines Agency has deferred the obligation to submit the results of studies with <{(Invented) Name}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in one or more subsets of the paediatric population in {condition, as per Paediatric Investigation Plan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Maltese: <il-prodott mediċinali ta' referenza li fih {isem tas-sustanza(i) attiva(i)}>] f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-{kondizzjoni kif imniżżel fid-deċiżjoni tal-Pjan ta' Implimentazzjoni Pedjatrika (PIP), għal indikazzjoni mogħtija}{ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku}>
English: <Interaction studies have only been performed in adults.>
Maltese: <Studji ta' interazzjoni twettqu biss f'adulti.>
English: What X looks like and contents of the pack
Maltese: Kif jidher X u l-kontenut tal-pakkett
English: <For instructions on <reconstitution> <dilution> of the medicinal product before administration, see section <6.6> <and> <12>.>
Maltese: <Għal struzzjonijiet fuq <ir-rikostituzzjoni> <id-dilwizzjoni> tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni <6.6>><u><12>.
English: <{DD month YYYY}>
Maltese: U MNEJN GĦANDU JINGĦATA
English: <X contains {name the excipient(s)}>
Maltese: <X fih {isem tal-eċċipjent(i)}>
English: <This medicine is subject to additional monitoring.
Maltese: <Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: <The European Medicines Agency has waived the obligation to submit the results of studies with <{(Invented) Name}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in all subsets of the paediatric population in {condition as per Paediatric Investigation Plan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Maltese: <il-prodott mediċinali ta' referenza li fih {isem tas-sustanza(i) attiva(i)}>] f'kull sett tal-popolazzjoni pedjatrika fil-{kondizzjoni kif imniżżel fid-deċiżjoni tal-Pjan ta' Implimentazzjoni Pedjatrika (PIP), għal indikazzjoni mogħtija}{ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku}>
English: <For storage conditions after <reconstitution> <dilution> <first opening> of the medicinal product, see section 6.3>
Maltese: <Għall-kondizzjonijiet ta' ħażna wara <r-rikostituzzjoni> <d-dilwizzjoni><l-ewwel ftuħ> tal-prodott mediċinali, ara sezzjoni 6.3.>
English: Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <...> <after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.>
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq <it-tikketta><il-kartuna><il-flixkun><...><wara {abbrevjazzjoni li tintuża għad-data ta' meta tiskadi }>.
English: <{X} is indicated in <adults> <neonates> <infants> <children> <adolescents> <aged {x to y}> <years> <months>.>
Maltese: <Għid <lit-tabib> <jew> <lill-ispiżjar> tiegħek jekk qiegħed <tieħu> <tuża>, <ħadt> <użajt> dan l-aħħar jew tista' <tieħu> <tuża> xi mediċina oħra.>
English: <This medicine has been authorised under “exceptional circumstances”.
Maltese: <Dan il-prodott mediċinali kien awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: <Excipient(s) with known effect>
Maltese: <Eċċipjent(i) b'effett magħruf>
English: How to <take> <use> X
Maltese: Kif gћandek <tieћu><tuża> X
English: See the end of section 4 for how to report side effects.> [For medicinal products subject to additional monitoring ONLY]
Maltese: Ara t-tmiem ta' sezzjoni 4 biex tara kif għandek tirrapporta effetti sekondarji. > (Għal prodotti mediċinali li huma suġġetti għal monitoraġġ addizzjonali
English: <There is no relevant use of {X} <in the paediatric population> <in children aged {x to y} <years>, <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...>.>
Maltese: <{X} <fil- popolazzjoni pedjatrika> <fit-tfal minn eta` {x sa y} <snin> <xhur> {jew xi kategoriji rilevanti oħra eż: piż, eta` tal-pubertà, sess} m'għandux użu rilevanti <għal indikazzjoni ta'.....>
English: <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.>
Maltese: <Fi studji li mhumiex kliniċi, l-effetti dehru biss wara esponimenti meqjusa ferm aktar għolja mill-massimu ta' esponiment fil-bniedem, li juru ftit li xejn rilevanza għall-użu kliniku.>
English: <Use in the paediatric population>
Maltese: <Użu fil-popolazzjoni pedjatrika>
English: For MRP and DCP procedures: The actual details of the national reporting system (as listed within the Appendix V) of the concerned Member State(s) shall be displayed on the printed version and may also be displayed in the electronic national translation, published or not published.
Maltese: {Isem ta' l-Istat Membru/Aġenzija} ser tirrevedi kull tip ta' informazzjoni ġdida li toħroġ kull sena u ser taġġorna dan is-Sommarju tal-Karatteristiċi tal-Prodott, skont il-bżonn.>
English: PHARMACEUTICAL form
Maltese: FARMAĊEWTIKU
English: Talk to your doctor <or> <,> <pharmacist> <or nurse> before <taking> <using> X
Maltese: <Kellem <lit-tabib> <jew> <l-ispiżjar> <jew l-infermier> tiegħek qabel <tieħu> <tuża> X
English: - <if you are allergic to {active substance(s)} or any of the other ingredients of this medicine (listed in section 6).>
Maltese: <jekk inti allerġiku għal{sustanza attiva(i)} jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).>
English: The full EPAR for ViraferonPeg 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: These contain 50, 80, 100, 120 or 150 micrograms of peginterferon alfa-2b in 0.5 ml.
Maltese: Dawn fihom 50, 80, 100, 120 u 150 mikrogramma peginterferon alfa-2b f'kull 0.5 ml.
English: In adults, the most common side effects with ViraferonPeg (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Maltese: Fl-adulti, l-iktar effetti sekondarji komuni bi ViraferonPeg (li dehru f'iktar minn pazjent wieħed minn kull 10) huma infezzjoni virali, farinġite (griżmejn xotti), anemija (għedud baxxi ta' ċelloli ħomor taddemm), newtropenja (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), telf tal-aptit, depressjoni, ansjetà, tibdil fil-burdata, konċentrazzjoni mdgħajfa, insomnja (diffikultà fl-irqad), uġigħ ta' ras, sturdament, dispneja (diffikultà fit-teħid tan-nifs), sogħla, rimettar, dardir, uġigħ addominali (uġigħ fl-istonku), dijarea, ħalq xott, alopeċja (telf ta' xagħar), prurite (ħakk), ġilda xotta, raxx, mijalġija (uġigħ fil-muskoli), artralġija (uġigħ fil-ġogi), uġigħ muskuloskeletali (fil-muskoli u fl-għadam), reazzjonijiet fis-sit tal-injezzjoni, infjammazzjoni fil-post tal-injezzjoni, għejja, astenja (djgħufija), irritabbiltà, tertir, pireksja (deni), mard simili għall-influwenza u telf fil-piż.
English: In adults, it is used in combination treatments at a dose of 1.5 micrograms per kilogram body weight, or on its own at 0.5 or 1.0 micrograms/kg.
Maltese: Fl-adulti, jintuża fi trattamenti ta' kombinazzjoni f'doża ta' 1.5 mikrogrammi għal kull kilogramma li jiżen ilpazjent, jew waħdu f'0.5 jew 1.0 mikrogrammi/kg.
English: The European Commission granted a marketing authorisation valid throughout the EU for ViraferonPeg on 29 May 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal ViraferonPeg fil-29 ta' Mejju 2000.
English: This document is a summary of the European Public Assessment Report (EPAR) for ViraferonPeg.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR) għal ViraferonPeg.
English: The interferon alfa-2b in ViraferonPeg 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-2b f'ViraferonPeg huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': isir minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi jipproduċi interferon alfa-2b.
English: In ViraferonPeg, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'ViraferonPeg, l-interferon alfa-2b ġie ‘pegylated' (imwaħħal ma' kimika magħrufa bħala polyethylene glycol).
English: ViraferonPeg peginterferon alfa-2b
Maltese: Sommarju tal-EPAR għall-pubbliku peginterferon alfa-2b