FrancophonIA/ELRC3.0 huggingface dataset:
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde).
Maltese: Storja medika ta' reazzjoni anafilattika (i.e. ta' periklu għall-ħajja) għal kwalunkwe mill-komponenti jew traċċi ta' residwi (ovalbumina, proteini li ġejjin mill-bajd u mit-tiġieġ, neomycin, octoxinol-9, formaldehyde).
English: After mixing: 10 doses of 0.5 ml per vial.
Maltese: Wara t-taħlit: 10 dożi ta' 0.5 ml f'kull kunjett.
English: Excipients: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Maltese: Sustanzi mhux attivi: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għall-injezzjonijiet.
English: Excipients: thiomersal, sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Maltese: Sustanzi mhux attivi: thiomersal, sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għall-injezzjonijiet.
English: Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02.
Maltese: Tilqim kontra l-influwenza, Kodiċi ATC:
English: Repeated injections of the vaccine induced moderate local inflammation in rabbits and no exacerbation of pneumonia after exposure to the parental wild-type virus in monkeys.
Maltese: Injezzjonijiet ripetuti tat-tilqima kkaġunaw infjammazzjoni lokali moderata fil-fniek u l-ebda aggravar ta' pnewmonja wara espożizzjoni għal virus parentali tat-tip selvaġġ fix-xadini.
English: - One pack of 10 vials (type I glass) of 4.5 ml emulsion (adjuvant) with stopper (chlorobutyl).
Maltese: - Pakkett wieħed ta' 10 kunjetti (ħġieġ ta' tip I) ta' 4.5 ml ta' emulsjoni (adjuvant) b'tapp
English: Do not use the antigen (suspension) and the adjuvant (emulsion) after the expiry date which is stated on the carton and the label after EXP.
Maltese: Tużax l-antiġen (suspensjoni) u l-adjuvant (emulsjoni) wara d-data ta' skadenza li tidher fuq il-kartuna u fuq it-tikketta wara EXP.
English: During a clinical study conducted with HUMENZA in adults and elderly, the side effects listed below have been observed.
Maltese: Matul studju kliniku bi HUMENZA li sar fuq persuni adulti u anzjani, l-effetti sekondarji elenkati hawn isfel kienu osservati.
English: A challenge ferret study showed vaccine similar protection after one or two human doses based on lung macroscopic examination, body weight loss (as indicator of disease after challenge) and viral loads in lungs and in the upper respiratory tract.
Maltese: Studju challenge fin-nemneminmsa wera protezzjoni simili tat-tilqima wara waħda jew żewġ dożi umani bbażat fuq eżami makroskopiku tal-pulmun, telf ta' piż tal-ġisem (bħala indikatur tal-marda wara ċ-challenge) u ammonti virali fil-pulmun u fin-naħa ta' fuq tal-apparat respiratorju.
English: All children aged from 3 to 8 years were seronegative prior to vaccination.
Maltese: It-tfal ta' bejn it-3 sa 8 snin kienu lkoll seronegattivi qabel it-tilqima.
English: Very limited data in children aged 6 to 35 months (N=96) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses indicate an increase in the rates of injection site reactions and general symptoms (see section 4.8.).
Maltese: Dejta limitata ħafna fi tfal li għandhom età ta' bejn 6 xhur u 35 xahar (N=96) li rċievew żewġ dożi ta' 0.25 ml (nofs id-doża tal-adulti) b'intervall ta' 3 ġimgħat bejn id-dożi, tindika żieda fir-rati ta' reazzjonijiet fis-sit tal-injezzjoni u tas-sintomi ġenerali (ara sezzjoni 4.8.).
English: Regarding unsolicited reactions after any vaccination, injection site warmth (4%) was reported in children from 3 to 8 years of age and oropharyngeal pain (6.1%) was reported in adolescents from 9 to 17 years of age.
Maltese: Rigward reazzjonijiet mux soliċitati wara kwalukwe tilqima sħana fis-sit tal-injezzjoni (4%) kien rrapportat fi tfal li kellhom bejn 3 snin u 8 snin u wġigħ orofarinġeali (6.1%) kien irrapportat f'adolexxenti li kellhom bejn 9snin sa 17 il sena
English: Split Influenza virus*, inactivated, containing antigen equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X179A)….....................................3.8 micrograms**
Maltese: Virus tal-Influwenza maqsum*, inattivat, li fih antiġen ekwivalenti għal: A/California/7/2009 (H1N1) bħal razza (NYMC X179A)…....................................3.8 mikrogrammi**
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroiku tal-Aġenzija Ewropea dwar ilMediċini ): http://www.ema.europa.eu
English: Children and adolescent (from 3 to 17 years of age):
Maltese: Tfal u adolexxenti (minn 3 snin sa 17-il sena):
English: There are very limited safety and immunogenicity data available from clinical studies with HUMENZA in adults aged over 60 years of age.
Maltese: Hemm dejta limitata ħafna disponibbli dwar is-sigurta u l-immunoġenicita minn studji kliniċi b'HUMENZA f'adulti li għandhom iktar minn 60 sena,
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Maltese: Wara t-tilqima tal-influwenza, riżultati tat-test tas-seroloġija li jkunu pożittivi-foloz jistgħu jinkisbu permezz tal-metodu ELISA għal antikorp għal virus tal-immunodefiċjenza umana-1 (HIV-1), il-virus tal-epatite Ċ u, b'mod speċjali, HTLV-1.
English: - Vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems.
Maltese: - Infjammazzjoni tal-vini/arterji (vaskulite) li tista' tirriżulta f'raxx tal-ġilda u f'każijiet rari ħafna fi problemi temporanji tal-kliewi.
English: Name and address of the manufacturers responsible for batch release sanofi pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil France sanofi pasteur
Maltese: Sanofi Pasteur Parc Industriel d'Incarville 27100
English: However, in a pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Maltese: Madankollu, f'sitwazzjoni pandemika, jista' jkun adattat għalik li tingħatalek it-tilqima, bil-patt li kura medika adattata tkun disponibbli immedjatament f'każ ta' reazzjoni allerġika.
English: Seroconversion factor*** [95% CI] * Proportion of subjects achieving a post-vaccination titer ≥1:40 ** For subjects with a pre-vaccination titer <1:10, proportion of subjects with a post-vaccination titer ≥1:40 and for subjects with a pre-vaccination titer ≥1:10, proportion of subjects with a ≥four-fold increase from pre- to post-vaccination titer *** Geometric mean of individual ratios (post-/pre-vaccination titers)
Maltese: Fattur ta' serokonverżjoni*** [95% CI] * Proporzjon ta' individwi li kisbu titer ta' wara t-tilqima ta'≥1: 40 ( ** Għal individwi b'titer ta' qabel it-tilqima ta' <1: 10 , proporzjon ta' individwi b'titer ta' wara ttilqima ta' ≥1: 40 u għal individwi b'titer ta' qabel it-tilqima ta'≥ 1: 10 , proporzjon ta' individwi b'żieda ta' ≥ erba' darbiet aktar tat-titer minn qabel sa wara t-tilqima *** Proporzjonijiet ġeometriċi medji tat-titer tal-individwi (titers ta' qabel/wara t-tilqima)
English: Regarding unsolicited reactions after any vaccination, diarrhoea (4.3 %) was reported in children from 6 to 11 months of age and cough (4.2 %) was reported in children from 12 to 35 months of age.
Maltese: Rigward reazzjonijiet mhux soliċitati wara kull tilqima dijarea (4.3%) kien irrapportat fi tfal li kellhom bejn 6 xhur u 11-il xahar u sogħla (4.2%) kien irraportat fi tfal li kellhom bejn 12-il xahar u 35 xahar .
English: Viral shedding was assessed by measuring viral replication in both nasal and throat swabs and results demonstrated that HUMENZA was able to consistently reduce the viral load in the upper respiratory tract.
Maltese: Il-tnaqqis virali kien evalwat billi tkejlet ir replikazzjoni virali bi swabs kemm nażali kif ukoll tal-griżmejn, u r-riżultati wrew li HUMENZA kien kapaċi jnaqqas b'mod konsistenti l-ammont virali fil-parti ta' fuq tal-apparat respiratorju.
English: Shivering
Maltese: Tertir
English: * Proportion of subjects achieving a post-vaccination titer ≥1:40 ** For subjects with a pre-vaccination titer <1:10, proportion of subjects with a post-vaccination titer ≥1:40 and for subjects with a pre-vaccination titer ≥1:10, proportion of subjects with a ≥four-fold increase from pre- to post-vaccination titer *** Geometric mean of individual ratios (post-/pre-vaccination titers)
Maltese: * Proporzjon ta' individwi li kisbu titer ta' wara t-tilqima ta' ≥1: 40 ** Għal individwi b'titer ta' qabel it-tilqima ta'<1: 10 , proporzjon ta' individwi b'titer ta' wara ttilqima ta' ≥ 1: 40 u għal individwi b'titer ta' qabel it-tilqima ta' ≥1: 10 , proporzjon ta' individwi b'żieda ta' ≥ erba' darbiet aktar tat-titer minn qabel sa wara t-tilqima *** Proporzjonijiet ġeometriċi medji tat-titer tal-individwi (titers ta' qabel/wara t-tilqima)
English: Take special care with HUMENZA: - if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde (see section 6.
Maltese: Oqgħod attent ħafna bi HUMENZA: - jekk kellek kwalunkwe reazzjoni allerġika, ħlief reazzjoni allerġika għal għarrieda li kienet ta' periklu għall-ħajja għal xi sustanza li hemm fit-tilqima, għal thiomersal, ovalbumina, proteini li ġejjin mill-bajd u mit-tiġieġ, neomycin, octoxinol-9, formaldehyde (ara sezzjoni 6.
English: In an open-label clinical trial, two doses (0.5 ml) of HUMENZA have been administered at a 3-week interval in 50 children from 3 to 8 years of age and 49 adolescents from 9 to 17 years of age.
Maltese: Fi prova klinika bit-tikketta tidher, żewġ dożi (0.5 ml) ta' HUMENZA ngħataw f'intervall ta' 3 ġimgħat lil 50 tifel u tifla li kellhom minn 3 sa 8 snin u lil 49 persuna adolexxenti li kellhom minn 9 snin sa 17-il sena.
English: All children aged from 6 to 35 months were seronegative prior to vaccination.
Maltese: It-tfal ta' bejn 6 sa 35 xahar kienu lkoll seronegattivi qabel it-tilqima.
English: These side effects may occur with HUMENZA.
Maltese: Dawn l-effetti sekondarji jistgħu jseħħu bi HUMENZA.
English: The severity of these reactions was from grade 1 (mild) to grade 2 (moderate).
Maltese: Is-severità ta' dawn ir-reazzjonijiet kienet minn grad 1 (ħafifa) sa grad 2 (moderata).
English: Pharmacovigilance The MAH will submit the results of a prospective cohort safety study in at least 9,000 patients in different age groups, including immunocompromised subjects, in accordance with the protocol submitted with the Risk
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq sejjer jissottometti r-riżultati ta' studju dwar is-sigurtà fuq koorti prospettiv f'mill-inqas 9,000 pazjent fi gruppi differenti ta' età, li jinkludu persuni immunokompromessi, b'konformità mal-protokoll sottomess mal-Pjan tal-Immaniġġar tar
English: The immunogenicity 21 days after each half-dose (0.25 ml) of HUMENZA in term of the seroprotection rate, the seroconversion rate and the seroconversion factor, using HI method, were as follows:
Maltese: L-immunoġeniċità 21 jum wara kull għotja ta' nofs doża (0.25 ml) ta' HUMENZA fir-rigward tar-rata ta' seroprotezzjoni, ir-rata ta' serokonverżjoni u l-fattur ta' serokonverżjoni, bl-użu tal-metodu HI kienu kif ġej:
English: The use of a second half-dose should take into consideration the information provided in sections 4.4, 4.8 and 5.1.
Maltese: L-użu tat-tieni doża għandu jikkunsidra l-informazzjoni pprovduta f'sezzjonijiet 4.4, 4.8 u 5
English: Elderly 81 years of age and over
Maltese: Anzjani 81 sena jew iżjed
English: Seronegative subjects prior to vaccination N= 7
Maltese: Persuni seronegattivi qabel ittilqima N= 7
English: Malaise
Maltese: INDIVIDWALI
English: 21 days after 1st dose Seroprotection rate* % [95% CI]
Maltese: 21 jum wara l-1 doża Rata ta' seroprotezzjoni* % [95% CI]
English: In an open-label clinical trial, two half-doses (0.25 ml) of HUMENZA have been administered at a 3week interval in 48 children from 6 to 11 months of age and in 48 children from 12 to 35 months of age.
Maltese: Fi studju kliniku bit-tikketta tidher, żewġ nofs dożi (0.25 ml) ta' HUMENZA ngħataw f'intervall ta' 3 ġimgħat lil 48 tifel u tifla li kellhom minn 6 sa 11-il xahar u lil 48 tifel u tifla li kellhom minn 12 sa 35 xahar.
English: Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal, and to residues (ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde).
Maltese: Il-kawtela hi meħtieġa meta din it-tilqima tingħata lil persuni b'sensittività eċċessiva magħrufa (ħlief reazzjoni anafilattika) għas-sustanza attiva, għal kwalunkwe mis-sustanzi mhux attivi, għal thiomersal, u għar-residwi (ovalbumina, proteini li ġejjin mill-bajd u mit-tiġieġ, neomycin, octoxinol-9, formaldehyde).
English: Children from 3 years of age, adolescents and adults up to 60 years of age: One dose of 0.5 ml at an elected date.
Maltese: Tfal minn 3 snin 'il fuq, adolexxenti u adulti sa 60 sena:
English: After mixing, 1 dose (0.5ml) contains:
Maltese: Wara t-taħlit, doża waħda (0.5 ml) ikun fiha:
English: Excipients:
Maltese: Tel.:
English: Adverse reactions reported following any vaccination are listed below according to the following frequency:
Maltese: Ir-reazzjonijiet avversi rrappurtati wara kull tilqima huma elenkati hawn taħt skont il-frekwenza li ġejja:
English: Very common (affects more than 1 user in 10) Common (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000) Rare (affects 1 to 10 users in 10,000) Very rare (affects less than 1 user in 10,000)
Maltese: Mhux komuni (jaffettwa minn 1 sa 10 utenti minn kull 1,000) Rari (jaffettwa minn 1 sa 10 utenti minn kull 10,000)
English: The symptoms (signs) of pandemic flu are similar to those of an ordinary flu but may be more severe.
Maltese: Is-sintomi (sinjali) ta' influwenza pandemika huma bħal dawk ta' influwenza ordinarja, iżda jistgħu jkunu iktar severi.
English: NAME OF THE MEDICINAL PRODUCT Adjuvant for HUMENZA emulsion for injection
Maltese: TAL-PRODOTT MEDIĊINALI Adjuvant għal HUMENZA emulsjoni għall-injezzjoni
English: One pack contains: - One pack containing 10 vials of 1.5 ml of suspension (antigen).
Maltese: Kull pakkett li jkun fih 10 kunjetti b'1.5 ta' suspensjoni (antiġen).
English: The adjuvant is a white opaque emulsion.
Maltese: It-tilqima tidher bħala emulsjoni opaka u bajda.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 7.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jimpenja ruħu li jwettaq l-istudji u lattivitajiet addizzjonali ta' farmakovigilanza kif inhu deskritt fil-Pjan ta' Farmakoviġilanza, kif inhu deciż fl-verżjoni 7.0 tas-Sistema ta' l-Immaniġġar tar-Riskju inkluz f' Modulu 1.8.2 talApplikazzjoni għall-awtorizzazzjoni għat-Tqegħid fis-Suq Applikazzjoni u aġġornamenti sussegwenti tas-Sistema ta' l-Immaniġġar tar-Riskju kif deciż mill-Kumitat ghall-Prodotti Mediċinali għall-Użu Uman ta' l-Aġenzija Ewropeja dwar il-Mediċini (CHMP).
English: HUMENZA can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for HUMENZA takes due account of the officially declared pandemic strain.
Maltese: HUMENZA jista' jitqiegħed fis-suq biss meta jkun hemm dikjarazzjoni uffiċjali ta' influwenza pandemika mill-WHO/EU, bil-kondizzjoni li d-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq jikkunsidra sew it-tip ta' influwenza pandemika uffiċjalment dikjarata.
English: In particular rates of fever (axillary temperature ≥38°C) may increase considerably after the second dose.
Maltese: B'mod partikolari, ir-rati ta' deni (temperatura minn taħt l-abt ta' ≥38°C) tista' tiżdied b'mod konsiderevoli wara t-tieni doża.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: - One pack containing 10 vials of 4.5 ml of emulsion (adjuvant).
Maltese: Kull pakkett li jkun fih 10 kunjetti b'4.5 ta' emulsjoni (adjuvant).
English: Tell the doctor requesting these tests that you have recently been given HUMENZA.
Maltese: L-ebda każ ta' doża eċċessiva ma ġie rrappurtat.
English: • Neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré Syndrome).
Maltese: • Disturbi newroloġiċi li jistgħu jirriżultaw f'ebusija tal-għonq, konfużjoni, tmewwit, uġigħ u dgħufija tad-dirgħajn/riġlejn, telf ta' bilanċ, telf ta' riflessi, paralisi ta' parti mill-ġisem jew tal-ġisem kollu (enċefalomajelite, nevrite, Sindrome ta' Guillain-Barré).
English: • Differences in the perception of touch, pain, heat and cold (paraesthesia),
Maltese: • Differenzi fil-perċezzjoni tas-sens tal-mess, uġigħ, sħana u kesħa (parestesija),
English: Information from non-clinical studies
Maltese: Informazzjoni minn studji mhux kliniċi
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Maltese: Meta persuna tingħata t-tilqima, is-sistema immuni (is-sistema ta' difiża naturali tal-ġisem) ser tipproduċi l-protezzjoni tagħha stess (antikorpi) kontra l-marda.
English: - If you have any further questions, ask your doctor or nurse.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew infermier/a tiegħek.
English: Read the package leaflet before use
Maltese: Inizzjazzjoni ta listudji sa Lulju
English: Common: injection site bruising, headache, cough.
Maltese: Fissit tal-injezzjoni: uġigħ, ħmura, nefħa, ebusija.
English: A mean body weight loss of 20% was recorded in control group 4 days after infection.
Maltese: Medja ta' telf ta' piż tal-ġisem ta' 20% kienet irreġistrata filgrupp tal-kontroll ta' 4 ijiem wara l-infezzjoni.
English: Each vaccine dose of 0.5 ml or 0.25 ml (half-dose) is withdrawn with a new sterile syringe for injection and administered intramuscularly.
Maltese: Kull doża tat-tilqima ta' 0.5 ml jew 0.25 ml (nofs doża) għandha tinġibed b'siringa għallinjezzjoni ġdida u sterilizzata u tingħata ġol-muskoli.
English: At the injection site: hardness, redness, swelling, bruising.
Maltese: Fis-sit talinjezzjoni: uġigħ, ħmura, ebusija, nefħa.
English: A single administration of a human dose of HUMENZA elicited HI titers ≥ 80 and MN (Microneutralization) titers ≥ 160 specific to the vaccinal strain in 100% of vaccinated animals and a two-dose administration regimen markedly increased (at least a 5-fold increase) HI and MN antibody titers.
Maltese: Għoti wieħed ta' doża umana ta' titers ta' HUMENZA ikkaġuna titers ta' HI ta' ≥ 80 u titers MN (Mikronewtralizzazzjoni) ta' ≥ 160 li kienu speċifiċi għar-razza tat-tilqima f'100 % tal-annimali mlaqqma, u programm tal-għoti ta' kors ta' żewġ dożi, żiedu b'mod notevoli (mill-inqas żieda ta' 5 darbiet) it-titers tal-antikorp ta' HI u MN.
English: Overall, systemic reactions were more frequently reported in children from 6 to 11 months compared to children from 12 to 23 months.
Maltese: Globalment, reazzjonijiet sistemiċi kienu rrappurtati b'mod iktar frekwenti fi tfal bejn 6 xhur sa 11-il xahar meta mqabbel ma' tfal ta' bejn 12-il xahar sa 23 xahar.
English: Antigen vial:
Maltese: Kunjett bl-antiġen:
English: The emulsion is white, opaque.
Maltese: L-emulsjoni hi bajda u opaka.
English: The adjuvant, AF03, was not mutagenic or clastogenic and induced transient inflammatory changes in repeat dose toxicity studies (in rats and rabbits).
Maltese: L-adjuvant, AF03, ma kienx mutaġeniku jew klastoġeniku u kkaġuna tibdil infjammatorju temporanju fi studji dwar tossiċità kkawżata minn dożi ripetuti (fil-firien u l-fniek).
English: PACKAGE LEAFLET: INFORMATION FOR THE USER HUMENZA Suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Maltese: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU HUMENZA Suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni Tilqima kontra l-influwenza pandemika (H1N1) (virijon maqsum, diżattivat, adjuvant)
English: Not computed
Maltese: U KWANTITATTIVA
English: Children (from 6 to 35 months of age):
Maltese: Tfal (li għandhom minn 6 xhur sa 35 xahar):
English: The immunogenicity 21 days after each dose has been assessed and is presented below for each age group according to the seroprotection rate, the seroconversion rate and the seroconversion factor, using haemagglutination inhibiting (HI) method.
Maltese: L-immunoġeniċità ġiet evalwata 21 jum wara kull injezzjoni u dan huwa ippreżentat hawn taħt għal kull grupp ta' eta skond ir-rata ta' seroprotezzjoni, ir-rata ta' serokonverżjoni u l-fattur ta' serokonverżjoni, bl-użu tal-metodu ta' emaglutinazzjoni li tinibixxi (HI).
English: Overall, a higher frequency of injection site reactions and fever was reported in this age group compared to the adolescents.
Maltese: Globalment, ir-reazzjonijiet kienu iktar frekwenti fit-tfal milli fl-adulti u fl-anzjani.
English: Common: injection site bruising, diarrhoea.
Maltese: Komuni: deni. tbenġil fis-sit tal-injezzjoni, dijarea.
English: 21 days after 1st dose
Maltese: 21 jum wara l-1 doża
English: Nervous system disorders - Very common: headache
Maltese: Disturbi fis-sistema nervuża - Komuni ħafna: uġigħ ta' ras
English: Vascular disorders: Vasculitis associated in very rare cases with transient renal involvement
Maltese: Vaskulite assoċjata f'każijiet rari ħafna ma' involviment renali temporanju
English: What HUMENZA contains
Maltese: X'fih HUMENZA
English: EU/1/12/815/001 7 tablets EU/1/12/815/002 14 tablets EU/1/12/815/003 28 tablets EU/1/12/815/004 42 tablets EU/1/12/815/005 98 tablets EU/1/12/815/006 49 tablets
Maltese: EU/1/12/815/001 7 pilloli EU/1/12/815/002 14-il pillola EU/1/12/815/003 28 pillola EU/1/12/815/004 42 pillola EU/1/12/815/005 98 pillola EU/1/12/815/006 49 pillola
English: Table 1 Frequencies of adverse reactions System Organ Class
Maltese: Tabella 1 Frekwenzi tar-reazzjonijiet avversi Sistema tal-klassifikazzjoni talOrgani
English: The absolute oral bioavailability of nalmefene is 41%.
Maltese: Il-biodisponibiltà orali assoluta ta' nalmefene hija 41%.
English: Date of first authorisation: 25 February 2013 Date of latest renewal: 10 November 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 25 frar 2013 Data tal-aħħar tiġdid: 10 Novembru 2017
English: TAC R70 0-4 HDD
Maltese: R70 0-4
English: Patients with severe renal impairment (eGFR <30 ml/min per 1.73 m
Maltese: Pazjenti b'indeboliment renali sever (eGFR <30 ml/min għal kull 1.73 m
English: DK-2500 Valby Denmark
Maltese: DK-2500 Valby Id-Danimarka
English: Nornalmefene is further converted to nornalmefene 3-O-glucuronide and nornalmefene 3O-sulphate.
Maltese: Nornalmefene huwa konvertit ukoll għal nornalmefene 3-O-glucuronide u nornalmefene 3-O-sulphate.
English: Each film-coated tablet contains 60.68 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 60.68 mg lactose.
English: Tachycardia Palpitations
Maltese: Takikardja Palpitazzjonijiet
English: Angioedema Urticaria Pruritus Rash
Maltese: Anġjoedema Urtikarja Prurite Raxx
English: This change is considered unlikely to be of clinical relevance.
Maltese: Din il-bidla hija meqjusa li mhux probabbli li tkunbħala klinikament relevanti.
English: Microcrystalline cellulose Lactose, anhydrous Crospovidone, type A Magnesium stearate
Maltese: Microcrystalline cellulose Lactose, anidrat Crospovidone, tat-tip A Magnesium stearate