FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle.
Maltese: Ir-riskju għal ekosistemi akwatiċi jista' jitnaqqas billi jiġi evitat użu ta' spiss u repetut ta' doramectin (u prodotti kontra l-ħniex tal-istess klassi) fil-baqar.
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle and sheep.
Maltese: Ir-riskju għal ekosistemi akwatiċi jista' jitnaqqas billi jiġi evitat użu ta' spiss u repetut ta' doramectin (u prodotti kontra l-ħniex tal-istess klassi) fil-baqar u n-nagħaġ.
English: It should be noted that due to the absence of a maximum residue limit (MRL) in milk the veterinary medicinal products containing doramectin are not authorised for use in lactating animals.
Maltese: Għandu jiġi nnotat li minħabba n-nuqqas ta' limitu ta' residwu massimu (MRL) fil-ħalib, il-prodotti mediċinali veterinarji li fihom doramectin mhumiex awtorizzati sabiex jintużaw f'annimali li jkunu qed ireddgħu.
English: In reindeer doramectin is administered as a single subcutaneous injection at a dose of 200 μg/kg bw for treatment of nematodes and throat bot.
Maltese: Fir-renni, doramectin jingħata bħala tilqima unika taħt il-ġilda b'doża ta' 200 μg/kg bw għat-trattament ta' nematodi u dud tal-griżmejn.
English: Iceland
Maltese: IL-FINLANDJA
English: While no data were available that would allow the establishment of the ratio of marker to total residues for milk, it was considered that the ratio established by CVMP for fat (0.86) could be applied to milk.
Maltese: Filwaqt li ma kien hemm l-ebda dejta disponibbli li tippermetti li jiġi stabbilit ilproporzjon tal-markatur meta mqabbel mar-residwi totali għall-ħalib, tqies li l-proporzjon stabbilit misCVMP għax-xaħam (0.86) jista' jiġi applikat għall-ħalib.
English: Using the data from a pivotal study with Dectomax Incjectable a withdrawal period of 65 days could be derived.
Maltese: Permezz tad-dejta minn studju pivotali b'Dectomax Incjectable seta' jissawwar perjodu ta' tiżmim ta' 65 jum.
English: Stroupežnického 17
Maltese: Westlaan 142
English: However, in view of the fact that the study was not performed in line with standards in place today, it was considered that the withdrawal period of 70 days recommended in the 2005 referral procedure under Article 34 of Directive 2001/82/EC for Dectomax 1% injectable solution for cattle and sheep (EMEA/V/A/009) should be maintained.
Maltese: Madankollu, fid-dawl tal-fatt li l-istudju ma sarx b'konformità mal-istandards fis-seħħ illum, tqies li għandu jinżamm il-perjodu ta' tiżmim ta' 70 jum rakkomandat fil-proċedura ta' riferiment tal-2005 skont l-Artikolu 34 tad-Direttiva 2001/82/KE għal Dectomax 1% soluzzjoni injettabbli għall-frat u nnagħaġ (EMEA/V/A/009).
English: Poland
Maltese: IL-POLONJA
English: • On the basis of the environmental risk assessment data submitted by the applicants/marketing authorisation holders for the injectable and pour-on veterinary medicinal products containing doramectin, the CVMP considered that in order to address the identified risks for aquatic organisms and dung fauna, as well as any remaining uncertainty regarding bioaccumulation, risk mitigation measure should be applied;
Maltese: • Fuq il-bażi tad-dejta dwar il-valutazzjoni tar-riskju ambjentali ppreżentata mill-applikanti/detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji injettabbli u għattferrigħ li fihom doramectin, is-CVMP qies li sabiex jiġu indirizzati r-riskji identifikati għall-organiżmi akwatiċi u l-fawna tad-demel, kif ukoll kwalunkwe inċertezza li jifdal rigward il-bijoakkumulazzjoni, għandha tiġi applikata miżura ta' mitigazzjoni tar-riskji;
English: In order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation the following risk mitigation measures are recommended for the injectable veterinary medicinal products containing doramectin:
Maltese: Biex jiġu indirizzati r-riskji identifikati għall-organiżmi akwatiċi u l-fawna tad-demel kif ukoll kwalunkwe inċertezza li jifdal rigward il-bijoakkumulazzjoni, huma rakkomandati l-miżuri ta' mitigazzjoni tar-riskji li ġejjin għall-prodotti mediċinali veterinarji injettabbli li fihom doramectin:
English: Having considered the residue depletion data submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, withdrawal periods of 70 days for cattle meat and offal, 70 days for sheep meat and offal, 77 days for pig meat and offal and 70 days for reindeer meat and offal were considered safe.
Maltese: Wara li ġiet ikkunsidrata d-dejta dwar it-tnaqqis tar-residwi ppreżentata mill-applikanti/detenturi talawtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji injettabbli li fihom doramectin, il-perjodi ta' tiżmim ta' 70 jum għal-laħam u l-ġewwieni tal-frat, 70 jum għal-laħam u l-ġewwieni tannagħaġ, 77 jum għal-laħam u l-ġewwieni tal-majjali u 70 jum għal-laħam u l-ġewwieni tar-renni tqiesu sikuri.
English: MG/ML SOLUCIÓN INYECTABLE PARA PORCINO
Maltese: MG/ML SOLUCIÓN
English: The outcome of the ERA indicates that RQ are higher than 1 in the Tier A assessment in two cases, namely aquatic invertebrates (following direct excretion scenario) and dung fauna.
Maltese: II. L-eżitu tal-ERA jindika li RQ huma ogħla minn 1 fil-valutazzjoni tal-Livell A f'żewġ każijiet, jiġifieri l-invertebrati akwatiċi (wara xenarju ta' eskrezzjoni diretta) u fawna tad-demel.
English: Do not use in pregnant ewes, which are intended to produce milk for human consumption, within 70 days of expected parturition.
Maltese: Tużax f'nagħaġ tqal, li huma intenzjonati li jipproduċu l-ħalib għall-konsum tan-nies, sa 70 jum qabel iwelldu.
English: Conclusion on the benefit-risk balance
Maltese: Valutazzjoni tar-riskju ambjentali
English: • On the basis of the residue depletion data in cattle, sheep, pigs and reindeer submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, the CVMP considered that withdrawal periods of 70 days for cattle meat and offal, 70 days for sheep meat and offal, 77 days for pig meat and offal and 70 days for reindeer meat and offal were safe;
Maltese: • Fuq il-bażi tad-dejta dwar it-tnaqqis tar-residwi fil-frat, in-nagħaġ, il-majjali u r-renni ppreżentata mill-applikanti/detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji injettabbli li fihom doramectin, is-CVMP qies li l-perjodi ta' tiżmim ta' 70 jum għal-laħam u l-ġewwieni tal-frat, 70 jum għal-laħam u l-ġewwieni tan-nagħaġ, 77 jum għal-laħam u lġewwieni tal-majjali u 70 jum għal-laħam u l-ġewwieni tar-renni kienu sikuri;
English: The Netherlands considered that it is in the interest of EU consumers and the environment to harmonise the withdrawal periods and the environmental risk mitigation measures and therefore, on 22 March 2012, the Netherlands presented to the European Medicines Agency a referral notification under Article 35 of Directive 2001/82/EC for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species.
Maltese: Il-Pajjiżi l-Baxxi qiesu li huwa fl-interess tal-konsumaturi tal-UE u l-ambjent li jiġu armonizzati l-perjodi ta' tiżmim u l-miżuri ta' mitigazzjoni tar-riskji u għaldaqstant, fit-22 ta' Marzu 2012, il-Pajjiżi l-Baxxi ppreżentaw lill-Aġenzija Ewropea għall-Mediċini notifika ta' riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE għall-prodotti mediċinali veterinarji injettabbli u għat-tferrigħ kollha li fihom doramectin li huma maħsubin sabiex jintużaw fi speċi mammali li jipproduċu l-ikel.
English: It is a macrocyclic lactone closely related to ivermectin.
Maltese: Huwa latton makroċikliku relatat mill-qrib ma' ivermectin.
English: Packaging Content (concentration)
Maltese: Il-pakkett Kontenut (konċentrazzjoni)
English: Package size
Maltese: Daqs talpakkett
English: Page 2/2©EMEA 2008
Maltese: Paġna 2/2©EMEA 2008
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR)
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA European Medicines Agency, 2008.
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA European Medicines Agency, 2008.
English: EPAR summary for the public
Maltese: Sommarju ta' l-EPAR għall-pubbliku
English: Nobilis OR Inac is a vaccine that contains a suspension of the bacterium Ornithobacterium rhinotracheale serotype A, strain B3263/91.
Maltese: Nobilis OR Inac huwa vaċċin li fih sospensjoni tal-batterju Ornithobacterium rhinotracheale serotip A, razza B3263/91.
English: In the broiler chicks, the immunity lasts until at least 14 days after hatching.
Maltese: Fil-brojlers, l-immunità ddum ta' lanqas 14-il jum wara t-tfaqqis.
English: Nobilis OR Inac contains small amounts of a killed bacterium called O. rhinotracheale serotype A, strain B3263/91.
Maltese: Nobilis OR Inac fih ammonti żgħar ta' batterju maqtul magħruf bħala O. rhinotracheale serotip A, razza B3263/91.
English: The first injection is given at an age of six to 12 weeks and the second at least six weeks later at an age of 14 to 18 weeks.
Maltese: L-ewwel injezzjoni tingħata fl-età ta' 12-il ġimgħa u t-tieni waħda ta' linqas sitt ġimgħat iktar tard fl-età ta' bejn 14 u 18-il ġimgħa.
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 abbażi tarrakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: The withdrawal period is zero days.
Maltese: Il-withdrawal period hu ta' żero ġranet.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis OR Inac exceed the risks for passive immunistaion of broilers induced by active immunisation of female broiler breeders to reduce infection with O. rhinotracheale serotype A when this agent is involved, and recommended that Nobilis OR Inac be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Nobilis OR Inac jegħelbu r-riskji tiegħu meta użat għat-tilqim passiv ta' brojlers biex inaqqas l-infezzjoni b'O. rhinotracheale serotip A meta jkun involut dan l-aġent, u rrakkomanda li Nobilis OR Inac jingħata l-awtorizzazzjoni għat-tqegħid fis-suq.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropea.
English: The studies looked at the levels of antibodies against O. rhinotracheale in the vaccinated breeders at four weeks after the second injection of the vaccine (22 weeks of age), and again at the end of the laying period (58 weeks of age).
Maltese: L-istudju analizzaw il-livelli ta' antikorpi kontra O. rhinotracheale fit-tiġieġ imlaqqam erba' ġimgħat wara t-tieni injezzjoni bil-vaċċin (fl-età ta' 22 ġimgħa), u mill-ġdid fi tmiem il-perjodu tal-bajd (58 ġimgħa).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis OR Inac to Intervet International on 24 January 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Nobilis OR Inac lil Intervet International fl-24 ta' Jannar 2003.
English: Nobilis OR Inac is a vaccine.
Maltese: Nobilis OR Inac hu vaċċin.
English: What is the risk associated with Nobilis OR Inac?
Maltese: X'riskju hu assoċjat ma' Nobilis OR Inac?
English: In the study, the levels of antibodies were higher in the vaccinated breeders than in those that did not receive the vaccine, both at 22 and at 58 weeks of age.
Maltese: Fl-istudju, il-livelli ta' antikorpi kienu ikbar fit-tiġieġ imlaqqma milli f'dawk li ma ngħatawx tilqima, kemm fl-età ta' 22 ġimgħa kif ukoll fl-età ta' 58 ġimgħa.
English: What is Nobilis OR Inac?
Maltese: X'inhu Nobilis OR Inac?
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jinsab fil-modulu 6 ta' dan l-EPAR.
English: Nobilis OR Inac is given as two 0.25-ml injections, either under the skin in the neck or into the breast muscle.
Maltese: Nobilis OR Inac jingħata bħala żewġ injezzjonijiet ta' 0.25-ml, jew taħt il-ġilda fil-għonq jew fil-muskolu tas-sider.
English: The bacterium has been inactivated (treated to make it unable to cause an illness).
Maltese: Il-batterju jiġi inattivat (ittrattat b'mod li ma jibqax kapaċi jikkawża mard).
English: Nobilis OR Inac is an emulsion (a mixture of oil- and water-based liquids) for injection.
Maltese: Nobilis OR Inac hu emusljoni (taħlita ta' likwidi b'bażi ta' żejt u ilma) għallinjezzjoni.
English: Why has Nobilis OR Inac been approved?
Maltese: Għaliex ġie approvat Nobilis OR Inac?
English: Nobilis OR Inac is used to vaccinate female chickens that are being used for breeding broilers (chickens bred for meat) against the bacterium O. rhinotracheale serotype A. This immunity is then passed on to the chickens' offspring, so that the broilers are protected against infection with the same type of bacteria.
Maltese: L-għan tiegħu huwa li jispjega kif il-valutazzjoni mwettqa mill-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad-dokumentazzjoni pprovduta, waslet għar-rakkomandazzjonijiet fuq il-kundizzjonijiet ta' l-użu.
English: The vaccine also contains an ‘adjuvant' (liquid paraffin) to stimulate a better response.
Maltese: Il-vaċċin fih ukoll ‘ajjutant' (żejt likwidu mhux raffinat) biex jistimula rispons aħjar.
English: Accidental injection of Nobilis OR Inac can cause severe pain and swelling, particularly if it is accidentally injected into a joint or finger.
Maltese: L-effikaċja ta' Nobilis OR Inac ġiet studjata f'żewġ studji ewlenin li qabblu l-effikaċja ta' Nobilis OR Inac ma' dik tan-nuqqas ta' tilqima.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istejtus ta' preskrizzjoni ta' dan il-prodott tista' tinstab fuq ittikketta/pakkett ta' barra.
English: Other information about Nobilis OR Inac:
Maltese: Tagħrif ieħor dwar Nobilis OR Inac:
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immunitarja (iddifiża naturali tal-ġisem) tiddefendi ruħha kontra l-mard.
English: Further information on Mirataz can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/mirataz.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/mirataz.
English: Other information about Mirataz
Maltese: Informazzjoni oħra dwar Mirataz
English: The most common side effects with Mirataz (which may affect more than 1 in 10 cats) are signs of local irritation or inflammation at the site where the ointment is applied and behavioural changes (increased meowing, hyperactivity, disoriented state or inability to co-ordinate muscle movements, lack of energy/weakness, attention seeking and aggression).
Maltese: L-effetti sekondarji l-aktar komuni b'Mirataz (li jistgħu jaffettwaw aktar minn qattus wieħed minn kull 10) huma sinjali ta' irritazzjoni lokali jew infjammazzjoni fis-sit fejn jiġi applikat l-ingwent u tibdil flimġiba (żieda fit-tnewwiħ, iperattività, stat diżorjentat jew nuqqas ta' abbiltà biex jiġu kkoordinati lmovimenti tal-muskoli,, nuqqas ta' enerġija/dgħufija, ġbid ta' attenzjoni u aggressjoni).
English: Mirataz received a marketing authorisation valid throughout the EU on 10 December 2019.
Maltese: Mirataz ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 10/12/2019.
English: The signs can range from mild to severe and include fever, agitation, increased reflexes, tremor, sweating, dilated pupils, diarrhoea, convulsions and seizures.
Maltese: Is-sinjali jistgħu jkunu ta' severità ħafifa għal serja u jinkludu deni, aġitazzjoni, żieda fir-riflessi, rogħda, għeriq, twessigħ tal-pupilli, dijarea, konvulżjonijiet u attakki ta' puplesija.
English: A clinical field trial performed in the US in cats who had at least 5% weight loss due to an underlying medical condition, showed that 14 days' treatment with Mirataz increased their bodyweight.
Maltese: Prova klinika fuq il-post li saret fl-Istati Uniti fuq qtates li kellhom telf fil-piż ta' mill-inqas 5 % minħabba kundizzjoni medika sottostanti, uriet li kura ta' 14-il jum b'Mirataz żiedet il-piż tal-ġisem tagħhom.
English: It contains the active substance mirtazapine.
Maltese: Fih is-sustanza attiva mirtażapina.
English: The medicine is applied topically to the inner pinna (inner surface of the ear) once daily for 14 days.
Maltese: Il-mediċina tiġi applikata b'mod topiku lill-pinna ta' ġewwa (superfiċje interna tal-widna) darba kuljum għal 14-il jum.
English: Mirataz must not be used in cats treated with the medicines cyproheptadine, tramadol or monoamine oxidase inhibitors (MAOIs) or treated with an MAOI in the 14 days before treatment with Mirataz, as there may be an increased risk of serotonin syndrome.
Maltese: Mirataz ma għandux jintuża fuq qtates li jkunu qed jingħataw kura bil-mediċini cyproheptadine, tramadol jew b'inibituri tal-monoamina ossidażi (MAOIs) jew li jkun ngħataw kura b'MAOI fl-14-il jum qabel il-kura b'Mirataz, minħabba li jista' jkun hemm riskju akbar tas-sindrome tas-serotonina.
English: This overview was last updated in October 2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Ottubru 2019.
English: Direct contact with the medicine should be avoided.
Maltese: Għandu jiġi evitat kuntatt dirett mal-mediċina.
English: For the full list of side effects and restrictions of Mirataz, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet rrappurtati b'Mirataz, ara l-fuljett ta' tagħrif.
English: Why is Mirataz authorised in the EU?
Maltese: Għaliex Mirataz huwa awtorizzat fl-UE?
English: How does Mirataz work?
Maltese: Kif jaħdem Mirataz?
English: People who are hypersensitive (allergic) to mirtazapine should avoid contact with Mirataz.
Maltese: Persuni li huma ipersensittivi (allerġiċi) għal mirtażapina għandhom jevitaw il-kuntatt ma' Mirataz.
English: Mirataz (mirtazapine)
Maltese: Kif jintuża Mirataz?
English: What are the risks associated with Mirataz?
Maltese: X'inhuma r-riskji assoċjati ma' Mirataz?
English: They include blocking some of the actions of serotonin and histamine, substances involved in the regulation of appetite, and an effect on levels of leptin, a hormone that controls hunger.
Maltese: Dawn jinkludu l-imblukkar ta' wħud mill-azzjonijiet tas-serotonina u tal-istamina, sustanzi involuti fir-regolamentazzjoni tal-aptit, u effett fuq il-livelli ta' leptin, ormon li jikkontrolla l-ġuħ.
English: Mirataz is a skin sensitiser and may cause eye and skin irritation.
Maltese: Aktar informazzjoni dwar Mirataz tinstab fuq is-sit elettroniku tal-Aġenzija:
English: The average weight gain after 14 days was approximately 130 g per cat and significantly higher than the average 10 g in the group receiving placebo (dummy treatment).
Maltese: Iż-żieda medja fil-piż wara 14-il jum kienet ta' madwar 130 g għal kull qattus u kienet sinfikantement ogħla mill-medja ta' 10 g fil-grupp li kien qiegħed jingħata plaċebo (kura finta).
English: Mirataz must not be used in breeding, pregnant or lactating cats, in cats less than 7.5 months of age or less than 2 kg bodyweight.
Maltese: Mirataz ma għandux jintuża fuq qtates għat-tgħammir, tqal jew li qegħdin ireddgħu, fuq qtates ta' inqas minn 7.5 xahar jew b'piż tal-ġisem ta' inqas minn 2 kilogrammi.
English: The medicine is available as an ointment to be applied on the skin.
Maltese: Il-mediċina tiġi bħala ingwent li għandu jiġi applikat fuq il-ġilda.
English: An overview of Mirataz and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Mirataz u għalfejn huwa awtorizzat fl-UE
English: The active substance is Ribavirin.
Maltese: Is-sustanza attiva hi ribavirin.
English: Bilirubin - Indirect
Maltese: Bilirubina - Indiretta
English: Genotype 2/3
Maltese: Ġenotip 2/3
English: 30 to 50 mL/min
Maltese: 30 sa 50 mL/min
English: > 4 mg/dL (adults)
Maltese: > 4 mg/dL (adulti)
English: Haemodialysis (ESRD)
Maltese: Emodijalisi (ESRD)
English: Adults:
Maltese: Adulti:
English: Study 22
Maltese: Studju 22
English: Date of first authorisation : 01 July 2009 Date of latest renewal : 16 January 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 01 ta' Lulju 2009 Data tal-aħħar tiġdid: 16 ta' Jannar 2014
English: Teratogenic risk
Maltese: Riskju teratoġeniku
English: Nucleoside analogues
Maltese: Analogi ta' nukleoside
English: Ribavirin (800 mg/day)
Maltese: Ribavirin (800 mg/jum)
English: Tmax (hr) Cmax (ng/mL) AUC* Apparent clearance L/hr/kg
Maltese: Tmax (hr) Cmax (ng/mL) AUC* Tneħħija apparenti L/hr/kg
English: 3 x 200 mg tabletsa
Maltese: 3 x 200 mg pillolia
English: Study 11
Maltese: Studju 11
English: HCV Genotype
Maltese: Ġenotip HCV
English: Haemoglobin Adult: ≥ 12 g/dL (females); ≥ 13 g/dL (males) Children and adolescents: ≥ 11 g/dL (females); ≥ 12 g/dL (males)
Maltese: Adulti: ≥ 12 g/dL (nisa); ≥ 13 g/dL (irġiel) Tfal u adoloxxenti: ≥ 11 g/dL (nisa); ≥ 12 g/dL (irġiel)
English: Ribavirin plus interferon
Maltese: Ribavirin ma' interferon
English: Genotype 1
Maltese: Ġenotip 1
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme*
Maltese: Sindromu ta' Stevens Johnson*, nekrolisi epidermali tossika*, eritema multiforme*
English: Film coating, composed of : polyvinyl alcohol - partly hydrolysed, macrogol / polyethylene glycol 3350, titanium dioxide (E171), talc, iron oxide red, iron oxide yellow, iron oxide black.
Maltese: Il-qoxra tal-kapsula; polyvinyl alcohol - parti idrolizzat, macrogol/ polyethylene glycol 3350, titanium dioxide (E171), talc, iron oxide red, iron oxide yellow, iron oxide black.
English: Nephrotic syndrome*
Maltese: Sindromu nefrotiku*
English: Alopecia, rash
Maltese: Alopeċja, raxx
English: (see section 5.1).
Maltese: (ara sezzjoni 4.4).
English: Ulcerative colitis*
Maltese: Kolite ulċerattiva *
English: (kg)
Maltese: (mg/kg)
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Maltese: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG
English: Rhabdomyolysis*, myositis*
Maltese: Rabdomijolisi*, mijositi*
English: Hepatic function abnormal
Maltese: Funzjoni epatika anormali
English: Tachycardia, palpitations
Maltese: Takikardja, palpitazzjonijiet
English: Tablet core; Calcium hydrogen phosphate anhydrous, croscarmellose sodium, povidone, magnesium stearate.
Maltese: Il-qalba tal-pillola; calcium hydrogen phosphate anidru, croscarmellose sodium, povidone, magnesium stearate.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 % ≤ 12 years of age.
Maltese: Kienu arwolati total ta' 118-il pazjent: 57 % irġiel, 80 % Kawkasi, u 78 % ġenotip 1, 64 % ≤ 12-il sena.
English: Ribavirin Teva Pharma B.V. tablets are packaged in aluminium blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinyl Acetate (PVAc)
Maltese: Il-pilloli Ribavirin Teva Pharma B.V. huma ppakkjati ġo folji tal-aluminju li jikkonsistu minn polyvinyl chloride (PVC)/polyethylene (PE)/polyvinyl acetate (PVAc)
English: Ribavirin is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Maltese: Ribavirin huwa analogu sintetiku ta' nucleosajd li wera attività in vitro kontra xi RNA u DNA tal-virusis.
English: *AUC12 (ng.hr/mL) for Ribavirin; AUC0-24 (IU.hr/mL) for interferon alfa-2b
Maltese: Ma sarx *AUC12 (ng.hr/mL) għal Ribavirin; AUC0-24 (IU.hr/mL) għal interferon alfa-2b
English: Neoplasm unspecified
Maltese: Pazjenti inkonsapevoli