FrancophonIA/ELRC3.0 huggingface dataset:
English: Immune response against a version of Celvapan containing A/H5N1 vaccine strains The immunogenicity of the vaccine containing 7.5 µg non-adjuvanted HA derived from strain A/Vietnam/1203/2004 has been evaluated in two clinical studies in adults aged 18 - 59 years (N = 312) and in older subjects aged 60 years and older (N = 272) following a 0, 21 day schedule.
Maltese: L-immunoġeniċità tal-vaċċin li fih 7.5 µg minn razza A/Vjetnam/1203/2004 mhux adjuvat derivata minn HA ġiet evalwata f'żewġ studji kliniċi fuq persuni adulti ta' bejn 18 - 59 sena (N = 312) u fuq individwi akbar fl-età ta' 60 sena u aktar (N = 272) billi kienet segwita skeda ta' 0, 21 ġurnata.
English: Children aged 6 months to 5 years:
Maltese: Tfal minn 6 xhur sa 5 snin:
English: In an observational safety study including 3216 subjects aged 6 months to 60 years and older, the nature of adverse events was consistent with those observed in other clinical studies in adults and children.
Maltese: Fi studju ta' osservazzjoni dwar is-sigurtà li kien jinkludi 3216 persuna mill-età ta' 6 xhur sa 60 sena u akbar, in-natura tal-avvenimenti avversi kienet konsistenti ma' dawk osservati fi studji kliniċi oħra fl-adulti u t-tfal.
English: Seroprotection / Seroneutralization rate*
Maltese: Fattur ta' serokonverżjoni***
English: Clinical studies in which a version of Celvapan containing HA derived from A/Vietnam/1203/2004 (H5N1) was administered at day 0 and at day 21 provide:
Maltese: Studji kliniċi li fihom verżjoni ta' Celvapan li kien fiha HA derivat minn A/Vietnam/1203/2004 (H5N1), ingħatat f'jum 0 u f'jum 21, jipprovdu:
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.
Maltese: It-tilqima hi mistennija li tipproteġi biss kontra influwenza kkawżata minn razez bħal ta' A/California/07/2009 (H1N1)v.
English: Celvapan (H1N1)v to healthy adults aged 18 years and older.
Maltese: Celvapan (H1N1)v lil persuni adulti b'saħħithom li kellhom 18-il sena jew iżjed.
English: MN Assay
Maltese: Assaġġ MN
English: • you are having a blood test to look for evidence of infection with certain viruses.
Maltese: • jekk tkun ser tagħmel xi test tad-demm biex tara hemmx evidenza ta' infezzjoni b'ċerti viruses.
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (e.g. formaldehyde, benzonase, sucrose) of this vaccine.
Maltese: Storja ta' reazzjoni anafilattika (jiġifieri ta' theddida għall-ħajja) għal xi komponenti jew residwi fi traċċa (eż. formaldehyde, benzonase, sucrose) ta' dan il-vaċċin.
English: The following additional adverse reactions have been reported in the post-marketing experience in adults and children receiving Celvapan (H1N1)v.
Maltese: Ir-reazzjonijiet avversi addizzjonali li ġejjin kienu rrappurtati fl-esperjenza ta' wara t-tqegħid fis-suq f'persuni adulti u tfal li kienu qed jirċievu Celvapan (H1N1)v.
English: ** ≥ 4-fold increase in MN titre *** geometric mean increase
Maltese: ** ≥ żieda 4 darbiet fl-MN titre
English: Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Maltese: Vaċċin kontra l-influwenza (H1N1)v (virijon sħiħ, derivat minn ċelluli Vero, inattivat)
English: In a clinical study the 7.5 µg dose of Celvapan (H1N1)v was administered to adults aged 18 to 59 years (N = 101) and older people over 60 years of age (N = 101).
Maltese: Fi studju kliniku, id-doża ta' 7.5 µg ta' Celvapan (H1N1)v ingħatat lil persuni adulti li kellhom minn 18 sa 59 sena (N = 101) u persuni akbar fl-età li kellhom iktar minn 60 sena (N = 101).
English: Seronegative subjects at baseline (≤ 4mm 21 Days After nd
Maltese: Persuni seronegattivi fil-linja bażi (≤ 4mm 21 Jum Wara ni
English: One pack of Celvapan contains 20 multidose vials of 5 ml suspension for injection for 10 doses.
Maltese: Pakkett wieħed ta' Celvapan fih 20 kunjett b'ħafna dożi ta' 5 ml ta' suspensjoni għall-injezzjoni għal 10 dożi.
English: PSYCHIATRIC DISORDERS
Maltese: DISTURBI PSIKJATRIĊI
English: Very common: Injection site redness, drowsiness, irritability, loss of appetite, crying
Maltese: Komuni ħafna: Ħmura fejn tingħata l-injezzjoni, ngħas, irritabilità, nuqqas ta' aptit, biki.
English: One dose of 0.5 ml at an elected date.
Maltese: Doża waħda ta' 0.5 ml f'data magħżula.
English: In a study with a similar influenza vaccine (containing a H5N1 vaccine strain) that included healthy adults and older people, subjects with a weakened immune system and patients with long-term conditions, the safety profile was similar to that in healthy adults.
Maltese: Fi studju b'vaċċin ta' influwenza simili (li fih ir-razza tal-vaċċin H5N1) li inkluda adulti u persuni akbar fl-età b'saħħithom, suġġetti b'sistema immuni mdgħajfa u pazjenti b'kundizzjonijiet fit-tul, il-profil tas-sigurtà kien simili għal dak f'adulti b'saħħithom.
English: Children and adolescents (3 - 17 years of age)
Maltese: Tfal u adoloxxenti (minn 3 xhur sa 17-il sena)
English: Side effects from clinical studies in adults and older people
Maltese: Effetti sekondarji minn studji kliniċi fl-adulti u f'persuni akbar fl-età
English: 20 multidose vials (10 doses per vial - 0.5 ml per dose)
Maltese: 20 kunjett b'ħafna dożi (10 dożi f'kull kunjett - 0.5 ml għal kull doża)
English: For further information, see sections 4.8 and 5.1.
Maltese: Għal aktar tagħrif, ara sezzjonijiet 4.8 u 5
English: Whole virion influenza vaccine, inactivated, containing antigen of strain*: 7.5 micrograms**
Maltese: Vaċċin ta' kontra l-influwenza ta' virjon sħiħ, inattivat, li fih antiġen ta' razza*: 7.5 mikrogrammi**
English: • Side effects observed during post-marketing surveillance
Maltese: • Effetti sekondarji osservati matul is-sorveljanza ta' wara t-tqegħid fis-suq
English: The safety of Celvapan in pregnancy and lactation has been assessed in a limited number of pregnant
Maltese: Is-sigurtà ta' Celvapan fit-tqala u t-treddigħ ġiet valutata f'numru limitat ta' nisa tqal.
English: Decreased appetite
Maltese: Nażofarinġite
English: From post-marketing surveillance with egg-derived trivalent seasonal influenza vaccines, the following serious adverse reactions have been reported:
Maltese: Minn sorveljanza ta' wara t-tqegħid fis-suq b'tilqim trivalenti kontra influwenza staġjonali derivat mill-bajd, ġew irrapportati r-reazzjonijiet avversi serji li ġejjin:
English: In children aged 6 to 35 months disturbed sleep and fever were very common, and decreased appetite, restlessness, irritability, crying and drowsiness were common.
Maltese: Fi tfal li kellhom minn 6 sa 35 xahar, disturb fl-irqad u deni kienu komuni ħafna, u tnaqqis fl-aptit, nuqqas ta' kwiet f'ġismek, irritabilità, biki u ngħas kienu komuni.
English: Skin and subcutaneous tissue disorders:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Celvapan suspension for injection
Maltese: IL-PRODOTT MEDIĊINALI Celvapan suspensjoni għall-injezzjoni
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Maltese: Disturbi newroloġiċi, bħal enċefalomajlite, nevrite u s-sindromu ta' Guillain Barré.
English: Clinical trials were conducted with a version of Celvapan containing a H5N1 vaccine strain (see section 5.1) in approximately 3700 subjects (ranging in age from 18 to 60 years and above), and in special risk groups of approximately 300 subjects each, consisting of immune-compromised subjects and patients with chronic disease conditions.
Maltese: Saru provi kliniċi b'verżjoni ta' Celvapan li fih razza ta' tilqima kontra H5N1 (ara sezzjoni 5.1) f'madwar 3,700 persuna (li kellhom minn 18 sa 60 sena u aktar), u fi gruppi b'riskju speċjali ta' madwar 300 persuna kull wieħed, li kienu jikkonsistu minn persuni immuni-kompromessi u pazjenti b'kundizzjonijiet ta' mard kroniku.
English: EXPIRY DATE EXP
Maltese: INFORMAZZJONI GĦALL-UTENT
English: • Injection site movement impairment
Maltese: • Indeboliment tal-moviment fis-sit tal-injezzjoni
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifatturi tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: In a clinical trial 51 children and adolescents aged 9 to 17 years and 51 children aged 3 to 8 years were administered the 7.5 µg dose of Celvapan (H1N1)v. The incidence and nature of symptoms after the first and second vaccination were similar to that observed in the adult and older population using
Maltese: Fi prova klinika, 51 tifel u tifla u adolexxenti li kellhom minn 9 sa 17-il sena u 51 tifel u tifla li kellhom minn 3 sa 8 snin, ingħataw id-doża ta' 7.5 µg doża ta' Celvapan (H1N1)v.
English: Common Common Common
Maltese: Komuni Komuni Komuni
English: Common Common Common Common Common Common
Maltese: Komuni Komuni Komuni Komuni
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3.
English: • generalized skin reactions including urticaria (hives)
Maltese: • Reazzjonijiet ġeneralizzati tal-ġilda li jinkludu urtikarja(ħorriqija)
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance(s), to any of the excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose.
Maltese: Hija meħtieġa l-kawtela meta dan il-vaċċin jingħata lil persuni b'sensittività eċċessiva magħrufa (għajr reazzjoni anafilattika) għas-sustanza(i) attiva(i), għal kwalunkwe sustanza mhux attiva u għal residwi ta' traċċa eż. formaldehyde, benzonase, jew sucrose.
English: The seroprotection rates, seroconversion rates and seroconversion factors reported in adults and older subjects were comparable with Celvapan (H1N1)v.
Maltese: Ir-rati ta' seroprotezzjoni, ir-rati ta' serokonverżjoni u l-fatturi ta' serokonverżjoni rrappurtati f'persuni adulti u f'persuni akbar fl-età kienu komparabbli ma' Celvapan (H1N1)v.
English: INFECTIONS AND INFESTATIONS Nasopharyngitis
Maltese: DISTURBI RESPIRATORJI, TORAĊIĊI
English: NAME OF THE MEDICINAL PRODUCT Celvapan suspension for injection
Maltese: TAL-PRODOTT MEDIĊINALI Celvapan suspensjoni għall-injezzjoni
English: Persistence of anti-HA antibodies 180 days after the first vaccination as measured by single radial haemolysis (SRH) and microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above was as follows:
Maltese: Il-persistenza ta' antikorpi anti-HA 180 wara l-ewwel tilqima, kif imkejla minn emolisi radjali waħidha (SRH) u assaġġ tal-mikronewtralizzazzjoni (MN) f'persuni adulti li kellhom minn 18 sa 59 sena u f'persuni akbar fl-età li kellhom 60 sena u iżjed, kienet kif ġej:
English: Adverse reactions from pediatric clinical trials with CELVAPAN (H1N1)v are listed in the table below.
Maltese: Reazzjonijiet avversi minn provi kliniċi b'CELVAPAN (H1N1)v fuq pazjenti pedjatriċi huma elenkati fit-Tabella hawn taħt.
English: NERVOUS SYSTEM DISORDERS Headache Dizziness
Maltese: FIS-SISTEMA NERVUŻA Uġigħ ta' ras Sturdament
English: Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Maltese: Kull doża ta' tilqima ta' 0.5 ml tinġibed ġo siringa għall-injezzjoni.
English: Clinical studies with Celvapan (H1N1)v currently provide:
Maltese: Studji kliniċi li saru dwar Celvapan (H1N1)v bħalissa jipprovdu:
English: Prophylaxis of influenza caused by A(H1N1)v 2009 virus (See section 4.4).
Maltese: Profilassi tal-influwenza ikkawżata minn virus A(H1N1)v 2009 (Ara sezzjoni 4.4). Celvapan għandu jintuża skont Il-Gwida Uffiċjali.
English: The side effects listed below have occurred with Celvapan (H1N1)v in clinical studies in adults, including older people.
Maltese: L-effetti sekondarji elenkati hawn taħt seħħew b'Celvapan (H1N1)v fi studji kliniċi fuq persuni adulti, li jinkludu persuni akbar fl-età.
English: Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by single radial hemolysis (SRH) and microneutralization assay (MN) in infants and young children aged 6 to 35 months was as follows:
Maltese: Il-persistenza tal-antikorpi anti-HA 180 jum u 360 jum wara l-ewwel tilqima, kif imkejla minn emolisi radjali waħda (SRH) u assaġġ ta' mikronewtralizzazzjoni (MN) fi tfal u adolexxenti mill-etajiet ta' 3 sa 17-il sena, kienet kif ġej:
English: Adverse reactions from clinical trials with Celvapan (H1N1)v in a healthy adult and older people are listed in the table below.
Maltese: Reazzjonijiet avversi minn provi kliniċi b'Celvapan (H1N1)v f'popolazzjoni ta' persuni adulti u persuni akbar fl-età b'saħħithom huma elenkati fit-tabella hawn taħt.
English: After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in children and adolescents aged 3 to 17 years were as follows:
Maltese: Wara t-tilqima, ir-rata ta' persuni b'titres ta' antikorpi li jinnewtralizzaw ta' ≥ 40, rata ta' serokonverżjoni u fattur ta' serokonverżjoni kif imkejla mill-assaġġ tal-mikronewtralizzazzjoni (MN) fi tfal li kellhom minn 3 sa 17-il sena kienu kif ġej:
English: Animal reproductive toxicology studies do not indicate harmful effects in regard to female fertility, embryo-foetal and pre- and post-natal toxicity.
Maltese: Studji ta' tossikoloġija riproduttiva ma juru ebda effetti ta' ħsara fir-rigward tal-fertilità fuq in-nisa, l-embriju-fetu u tossiċità ta' qabel u wara t-twelid.
English: After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in children aged 6 to 35 months
Maltese: Wara t-tilqima, ir-rata ta' pazjenti b'titres ta' antikorpi li jinnewtralizzaw ta' ≥ 40, rata ta' serokonverżjoni u fattur ta' serokonverżjoni kif imkejla mill-assaġġ tal-mikronewtralizzazzjoni (MN) fi tfal li kellhom minn 6 sa 35 xahar kienu kif ġej:
English: * SRH area > 25 mm² ** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
Maltese: * erja SRH > 25 mm²; MN titer ≥1:40; ** jew erja SRH > 25 mm² jekk il-kampjun fil-linja bażi jkun negattiv jew żieda ta' 50% fl-erja
English: Dose nd
Maltese: Doża el
English: What Celvapan looks like and contents of the pack Celvapan is a clear to opalescent, translucent liquid.
Maltese: Celvapan huwa likwidu minn ċar sa opalexxenti u transluċidu.
English: • Injection site erythema
Maltese: • Eritema fis-sit tal-injezzjoni
English: Non-Clinical data obtained with Celvapan containing a H5N1 vaccine strain demonstrated alterations in liver enzymes and calcium levels in repeat dose toxicity studies in rats.
Maltese: Tagħrif mhux kliniku miksub b'Celvapan li kien fih vaċċin ta' razza H5N1, wera bidliet fl-enzimi tal-fwied u l-livell tal-kalċju fi studji dwar l-effett tossiku minn dożi ripetuti fil-firien.
English: • you have problems with your immune system, since your response to the vaccine may then be poor.
Maltese: • jekk għandek problema bis-sistema immuni tiegħek, minħabba li r-rispons tiegħek għat-tilqima jista' mbagħad ikun wieħed dgħajjef.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Maltese: FARMAĊEWTIKA U KONTENUT Suspensjoni għall-injezzjoni.
English: • you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to formaldehyde, benzonase, or to sucrose.
Maltese: • jekk kellek reazzjoni allerġika, li mhix reazzjoni allerġika ta' theddida għal ħajja għal xi sustanza li tinsab fil-vaċċin, għal formaldehyde, benzonase jew għal sucrose (ara sezzjoni 6.
English: After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Maltese: Wara t-tilqima, ir-rata ta' pazjenti b'titres ta' antikorpi li jinnewtralizzaw ta' ≥ 40, rata ta' serokonverżjoni u fattur ta' serokonverżjoni kif imkejla mill-assaġġ tal-mikronewtralizzazzjoni (MN) f'persuni adulti li kellhom minn 18 sa 59 sena u f'persuni akbar fl-età li kellhom 60 sena jew iżjed
English: • The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/(H1N1)v vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Maltese: • Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiftehem mal-Istati Membri dwar miżuri li jiffaċilitaw l-identifikazzjoni u traċċabilità tal-vaċċin A/(H1N1)v li jingħata lil kull pazjent, sabiex jiġu minimizzati żbalji waqt l- mediċazzjoni u biex pazjenti u professjonisti fil-qasam tal-kura tas-saħħa jiġu mgħejjuna jirraportaw reazzjonijiet avversi.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Maltese: L-immunizzazzjoni għandha ssir permezz ta' injezzjoni ġol-muskoli preferibbilment fil-muskolu deltojde jew fil-koxxa anterolaterali, skont il-massa muskolari.
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature.
Maltese: Madankollu, l-istabbiltà kimika u fiżika waqt l-użu kienet murija għal 3 sigħat fit-temperatura tal-kamra.
English: Children and adolescents 6 months to 17 years of age In a clinical study the frequency and type of side effects after the first and second injection were basically similar to that seen in the adult and older population using Celvapan.
Maltese: Fi studju kliniku, il-frekwenza u t-tip ta' effetti sekondarji wara l-ewwel u t-tieni injezzjoni kienu bażikament simili għal dawk osservati fil-popolazzjoni adulta u anzjana li kienet tuża Celvapan.
English: The safety profile in healthy subjects > 60 years of age, in immune-compromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy subjects.
Maltese: Il-profil tas-sigurtà f'individwi b'saħħithom li kellhom > 60 sena ta' l-età, f'individwi immuni-kompromessi u f'pazjenti b'kundizzjonijiet ta' mard kroniku, hu simili għall-profil tas-sigurtà f'individwi b'saħħithom.
English: Insomnia
Maltese: IL-PROVVISTA
English: After vaccination the seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Maltese: Wara t-tilqima, ir-rata ta' seroprotezzjoni, ir-rata ta' serokonverżjoni u l-fattur ta' serokonverżjoni għal antikorp anti-HA kif imkejjel minn emolisi radjali waħidha (SRH) f'persuni adulti li kellhom minn 18 sa 59 sena u f'persuni akbar fl-età li kellhom 60 sena u iżjed, kienu kif ġej:
English: Tell the doctor requesting these tests that you have recently been given Celvapan.
Maltese: L-ebda każ ta' doża eċċessiva ma ġie rrappurtat.
English: The seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in children and adolescents aged 3 to 17 years were as
Maltese: Ir-rata ta' seroprotezzjoni, ir-rata ta' serokonverżjoni u l-fattur ta' serokonverżjoni għal antikorp anti-HA kif imkejjel minn emolisi radjali waħidha (SRH) fi tfal u adolexxenti li kellhom minn 3 sa 17-il sena kienu kif ġej:
English: • vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney
Maltese: • Vaskulite (infjammazzjoni tal-vini u tal-arterji li tista' tikkawża raxx tal-ġilda, uġigħ fil-ġogi u problemi fil-kliewi)
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Whole virion influenza vaccine, inactivated containing antigen of strain *:
Maltese: U KWANTITATTIVA Vaċċin kontra l-influwenza b'virijon sħiħ, inattivat, li fih antiġen ta' razza*:
English: Seronegative subjects at baseline 21 Days After nd
Maltese: Persuni li kienu seronegattivi fil-linja bażi (< 1:10) 21 Jum Wara ni
English: • Clinical trials with a version of Celvapan containing a H5N1 vaccine strain
Maltese: • Provi kliniċi b'Celvapan (H1N1)v
English: Specifically, headache, vertigo (spinning feeling), cough, feeling sick, vomiting, diarrhoea, pain in the arms or legs and tiredness were observed commonly in children and adolescents.
Maltese: Speċifikament, uġigħ ta' ras, sturdament (sensazzjoni li tħoss kollox idur bik), sogħla, tħossok imdardar, rimettar, dijarea, uġigħ fid-dirgħajn jew fir-riġlejn u għeja kienu osservati b'mod komuni fit-tfal u
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI
English: A dose (0.5 ml) of the vaccine will be given.
Maltese: Doża (0.5 ml) tat-tilqima ser tingħata.
English: Uncommon: Cough
Maltese: Repubblika Ċeka
English: * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin
Maltese: • Imnieħer inixxi u wġigħ fil-griżmejn • Insomnija (diffikultà biex torqod)
English: Adults aged 18 years and older
Maltese: Adulti minn 18-il sena 'l fuq:
English: “Possible side effects” may affect your ability to drive or use
Maltese: Effetti sekondarji possibbli
English: <Content (concentration)>
Maltese: <Kontenut (konċentrazzjoni)>
English: 60 vials powder + 60 vials solvent + 60 3 ml syringes + 60 1 ml syringes + 180 alcohol swabs
Maltese: 60 kunjett bi trab + 60 kunjett b'solvent + 60 siringa ta' 3 ml + 60 siringa ta' 1 ml + 180 imselħa bl-alkoħol
English: powder: 90 mg; solvent: 2 ml
Maltese: trab: 90 mg; solvent:
English: <EMA procedure number> <MA (EU) number>
Maltese: <Numru tal-proċedura ta' l-EMA> <Numru ta' l-EU> <Numru tal-MA>
English: Fuzeon mg/ml
Maltese: 90 mg/ml
English: Subcutaneous use powder: vial (glass); solvent: vial (glass)
Maltese: Użu għal taħt il-ġilda trab: kunjett (ħġieġ); solvent: kunjett (ħġieġ)
English: Powder and solvent for solution for injection
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni
English: Pack size
Maltese: Fuzeon
English: Height (cm) x ks
Maltese: Tul (ċm) x ks
English: Aurovitas Spain, S.A.U.
Maltese: Aurovitas Spain, S.
English: 3 years.
Maltese: 3snin.
English: Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland
Maltese: Reykjavíkurvegur 76-78 220
English: BG-5600 Troyan Bulgaria
Maltese: BG-5600
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Maltese: Nekroliżi epidermali tossiku, sindromu ta' StevensJohnson, eritema multiforme
English: • pancreatitis;
Maltese: • pankreatite;
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' eċċipjenti , ara sezzjoni 6.1.
English: • anorexia (loss of appetite);
Maltese: • anoressija (telf t'aptit);
English: Levetiracetam caused mild induction of CYP2B6 and CYP3A4.
Maltese: Levitiracetam ikkawża induzzjoni ħafifa ta' CYP2B6 u CYP3A4.
English: 300 ml oral solution
Maltese: 300 ml Soluzzjoni orali
English: Oral solution.
Maltese: Soluzzjoni orali.
English: Levetiracetam Actavis Group contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, maltitol, propylene glycol and sodium.
Maltese: Levetiracetam Actavis Group fih methyl parahydroxybenzoate, propyl parahydroxybenzoate, maltitol, propylene glycol u sodium.
English: Creatinine clearance (ml/min/1.73m2)
Maltese: tal-krejatinina (ml/min/1.73m2)
English: A. Potamitis Medicare Ltd Τηλ: +357 22583333
Maltese: Potamitis Medicare Ltd Τηλ: +357 22583333
English: Liver function test abnormal
Maltese: Test tal-funzjoni tal-fwied abnormali
English: Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ammonium glycyrrhizate
Maltese: Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ammonium glycyrrhizate Glycerin