FrancophonIA/ELRC3.0 huggingface dataset:
English: However, in severe inflammation of the intestinal mucosa, especially in combination with renal insufficiency, side effects that occur when vancomycin is administered parenterally may appear.
Maltese: Madankollu, flinfjammazzjoni severa tal-mucosa intestinali, speċjalment flimkien mal-insuffiċjenza renali, jistgħu jidhru effetti sekondarji li jseħħu meta vankomiċin huwa amministrati parenteralment.
English: The emergence of resistance towards vancomycin differs from one hospital to another and a local microbiological laboratory should therefore be contacted for relevant local information.
Maltese: Il-ħruġ tar-resistenza għall-vankomiċin tvarja minn Sptar wieħed għall-ieħor u laboratorju mikrobijoloġiċi lokali għandu għalhekk jiġi kkuntattjat għall-informazzjoni lokali rilevanti.
English: Vasculitis
Maltese: Anzjani
English: Vancomycin capsules are not appropriate for the treatment of children under the age of 12 years or for adolescents unable to swallow them.
Maltese: Kapsuli vancomycin mhumiex xierqa għal tfal taħt 12-il sena jew għal adolexxenti li ma jistgħux jibilgħuhom.
English: Drug interactions with anti-motility agents and proton pump inhibitors Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered.
Maltese: Interazzjonijiet ma' aġenti kontra l-motilità u pompa inibituri proton Aġenti anti-motilità għandhom jiġu evitati u l-użu ta' inibitur proton pump għandu jerġa' jiġi kkunsidrat.
English: Serial tests of auditory function may be helpful in order to minimise the risk of ototoxicity in patients with an underlying hearing loss, or who are receiving concomitant therapy with an ototoxic agent such as an aminoglycoside.
Maltese: Serje ta' testijiet tal-funzjoni tas-smigħ jistagħu jkunu utli sabiex jiġi minimizzat ir-riskju ta' ototossiċità f'pazjenti b' telf tas-smigħ sottostanti, jew li qed jirċievu terapija konkomitanti ma' aġent ototossiku bħal aminoglycoside.
English: Vascular disorders: Common
Maltese: Arrest kardijaku Disturbi vaskulari Komuni:
English: [For all vancomycin 1000 mg powder for concentrate for solution for infusion, the following wording to be reflected in this section]
Maltese: [Għall-vankomiċin kollu 1000 mg trab għal konċentrat għal soluzzjoni għall-infużjoni, il-kliem li ġejjin biex tkun riflessa f'din it-Taqsima]
English: Vancomycin should be administered orally for this indication.
Maltese: Il-vankomiċin għandu jiġi amministrat oralment għal din l-indikazzjoni.
English: 3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
Maltese: 3 - Terġax tuża l-antibijotiku mingħajr preskrizzjoni medika, anki jekk trid tikkura marda simili.
English: In patients on intermittent haemodialysis, vancomycin levels should be usually obtained before the start of the haemodialysis session.
Maltese: Fil-pazjenti fuq l-haemodialysis intermittenti, il-livelli tal-vankomiċin għandhom jinkisbu normalment qabel il-bidu tas-sessjoni ta' haemodialysis.
English: (see section 6.
Maltese: (ara sezzjoni 6.
English: • Active substance:
Maltese: • Sustanza attiva:
English: (Arise from Q1 RR#13)
Maltese: (Tinkiseb minn Q1 RR#13)
English: 3.75 micrograms**
Maltese: 3.75 mikrogrammi**
English: 3.75 micrograms*
Maltese: 3.75 mikrogrammi*
English: 05 March 2010
Maltese: 05 ta' Marzu 2010
English: 71-80 years
Maltese: 71-80 sena
English: Quality
Maltese: Kwalità
English: >80 years
Maltese: >80 sena
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/624/001
Maltese: FIS-SUQ EU/1/10/624/001
English: PSUR submission during the influenza pandemic:
Maltese: Sottomissjoni ta' PSUR waqt l-influwenza pandemika:
English: anti-HA antibody
Maltese: antikorp anti-HA
English: 30 April 2010
Maltese: 30 ta' April 2010
English: 24-35 months4
Maltese: 24-35 xahar4
English: NA= not available
Maltese: NA = mhux disponibbli
English: >60 years
Maltese: >60 sena
English: Day 42 N=1,488
Maltese: Ġurnata 42 N=1,488
English: Димитър Манов бл.10 София 1408
Maltese: Димитър Манов бл.10
English: Arepanrix is a vaccine against a pandemic influenza (flu).
Maltese: Arepanrix huwa vaċċin kontra l-influwenza pandemika (influwenza).
English: 50 vials: emulsion (adjuvant)
Maltese: 50 kunjett: emulsjoni (stimulant)
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgium
Maltese: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Il-Belġju
English: Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1).
Maltese: Profilassi ta' influwenza f'sitwazzjoni ta' influwenza pandemika ddikjarata uffiċjalment (ara sezzjonijiet 4.2 u 5.1).
English: Interpandemic trivalent vaccines
Maltese: Vaċċini trivalenti interpandemiċi
English: 6-9 years
Maltese: 6-9 snin
English: Elderly (>60 years)
Maltese: Anzjani (> 60 sena)
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Maltese: Mhux komuni (≥1/1,000 to <1/100) Rari (≥1/10,000 to <1/1,000)
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
Maltese: Vaċċini ta' l-influwenza, Kodiċi ATC J07BB02.
English: Immune response to Arepanrix (H1N1) in adults aged 18-60 years:
Maltese: Rispons immune għal Arepanrix (H1N1) f'adulti b'età minn 18 sa 60 sena:
English: Immune response to A/Indonesia/5/2005 18-60 years
Maltese: Rispons immuni għal A/Indonesia/5/2005 18-60 sena
English: Day 180 N=353
Maltese: Ġurnata 180 N=353
English: Immune response to A/Indonesia/5/2005
Maltese: Rispons immuni għal A/Indonesia/5/2005
English: Seroconversion factor3
Maltese: Fattur ta' serokonverżjoni3
English: Nervous system disorders Febrile convulsions
Maltese: Disturbi fis-sistema nervuża
English: Pharmacovigilance The Applicant/MAH commits to support a Postauthorisation study in immunocompromised subjects (adults with HIV) being conducted by PCIRN (Public Health Agency of Canada - Canadian Institutes of Health Research Influenza Research Network) and provide the final result
Maltese: Farmakoviġilanza L-Applikant/MAH jikkommetti ruħu li jappoġġa studju wara l-Awtorizzazzjoni f'individwi immunokompromessi (adulti bl-HIV) li qed jiġi mwettaq minn PCIRN (Public Health Agency of Canada - Canadian Institutes of Health Research Influenza Research Network) u li jipprovdi rriżultat finali
English: Suspension vial:
Maltese: Kunjett ta' suspensjoni:
English: Day 42 N=479
Maltese: Ġurnata 42 N=479
English: - Challenge with a heterologous pandemic H5N1 strain (A/Hong Kong/156/97)
Maltese: - Sfida b'razza eterologa ta' H5N1 pandemika (A/Hong Kong/156/97)
English: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
Maltese: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl)
English: Day 180 N=104
Maltese: Ġurnata 180 N=104
English: Adults aged 18-60 years:
Maltese: Adulti b'età minn 18 sa 60 sena:
English: 1seroprotection rate (i.e. proportion of subjects with HI titre ≥ 1:40);
Maltese: 1 rata ta' seroprotezzjoni (i.e. proporzjon ta' individwi b'titre ta' HI ≥ 1:40);
English: 3-5 years
Maltese: 3-5 snin
English: Excipients: the vaccine contains 5 micrograms thiomersal
Maltese: Il-vaċċin fih 5 mikrogrammi thiomersal
English: Clinical
Maltese: Klinik
English: - Challenge with a homologous pandemic H5N1 strain (A/Indonesia/5/05)
Maltese: - Sfida b'razza omologa ta' H5N1 pandemika (A/Indonesia/5/05)
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Maltese: Dan il-prodott mediċinali fih thiomersal (kompost organomerkuriku) bħala preservattiv u għalhekk hemm il-possibilta` ta' reazzjonijiet ta' sensittivita` (ara sezzjoni 4.4).
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest (AESI).
Maltese: • Avvenimenti avversi li għandhom jingħataw prijorita' biex ikunu rrapurtati, i.e. reazzjonijiet avversi li jistgħu ikunu fatali jew ta' periklu għal ħajja, reazzjonijiet avversi severi mhux mistennija, avvenimenti avversi ta' interess speċjali (AESI).
English: 31-January-2010
Maltese: 31ta' Jannar 2010
English: • Clinical trials
Maltese: • Provi kliniċi
English: • Itching, rash
Maltese: • Ħakk, raxx
English: B-1330 Rixensart Belgium
Maltese: B-1330 Rixensart
English: Prospective cohort: initiated 23 Oct 2009; First endpoints available in Feb
Maltese: Ko-orti prospettiv: inbeda 23 ta' Ottubru 2009;
English: Study initiated in October 2009; Final report foreseen in April 2010
Maltese: Rapport finali previst f'April 2010
English: For a full list of excipients see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Study D-Pan H1N1-008 evaluated immunogenicity in healthy subjects (N=120) aged >60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age).
Maltese: Studju D-Pan H1N1-008 evalwa l-immunoġeniċità f'individwi b'saħħithom (N=120) b'età >60 sena (imqassma fi gruppi minn 61 sa 70, 71 sa 80 u > 80 sena).
English: Adults aged 18-60 years
Maltese: Adulti b'età minn 18 sa 60 sena
English: Seroprotection rate1
Maltese: Rata ta' seroprotezzjoni1
English: Antigen suspension for injection 50 vials: suspension
Maltese: Antiġen suspensjoni għall-injezzjoni 50 kunjett: suspensjoni
English: Day 180 N=141
Maltese: Ġurnata 180 N=141
English: For adjuvants, see section 2.
Maltese: Għal sustanzi supplimentari, ara sezzjoni 2.
English: GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89
Maltese: FIS-SUQ GlaxoSmithKline Biologicals s.a. rue de l'Institut 89
English: Ear and labyrinth disorders Uncommon: vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Mhux komuni: vertigo
English: Day 21 N=145
Maltese: Ġurnata 21 N=145
English: Pharmacovigilance The Applicant/MAH will support one prospective and one retrospective cohort safety study with Arepanrix, in at least 9,000 patients, in accordance with the protocols submitted with the Risk Management Plan.
Maltese: Farmakoviġilanza L-Applikant/MAH se jappoġġa studju wieħed prospettiv u retrospettiv dwar is-sigurtà b'Arepanrix, f'minn ta' linqas 9,000 pazjent, skont il-protokols sottomessi malPjan ta' l-Immaniġġjar tar-Riskju.
English: Gastrointestinal
Maltese: Gastro-intestinali
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Maltese: Ir-rilevanza klinika ta' titre ta' inibizzjoni ta' l-emagglutinazzjoni (HI) ≥1:40 fit-tfal mhux magħrufa.
English: Day 42 N=145
Maltese: Ġurnata 42 N=145
English: PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
Maltese: U KONTENUT Stimulant emulsjoni għall-injezzjoni 25 kunjett: emulsjoni
English: Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of age.
Maltese: Sintomi gastro-intestinali u tregħid seħħew b'rata ogħla fi tfal b'età minn 10 snin sa 17-il sena.
English: A 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was achieved in 44.7% of subjects at day 21, 53.2% at day 42 and 38.3% at day 180.
Maltese: Intlaħqet żjieda ta' 4 darbiet fl-antikorpi newtralizzanti fis-serum kontra A/Vietnam/1194/2004 f'44.7% ta' l-individwi f'ġurnata 21, 53.2% f'ġurnata 42 u 38.3% f'ġurnata 180.
English: Split influenza virus, inactivated, containing antigen* equivalent to:
Maltese: Virus maqsum, mhux attivat ta' l-influwenza li jkun fih antiġen* ekwivalenti għal:
English: Analysis of a subset of 36 subjects aged 6 months to 35 months old showed that 80.6 % had a 4 fold increase in serum neutralising antibodies 21 days after the first dose (66.7 % in 12 subjects aged 6 to 11 months old, 91.7 % in 12 subjects aged 12 to 23 months old and 83.3 % in 12 subjects aged 24 to 35 months old).
Maltese: Analiżi ta' sottogrupp ta' 36 individwu b'età minn 6 xhur sa 35 xahar uriet li 80.6 % kellhom żjieda ta' 4 darbiet fl-antikorpi newtralizzanti fis-serum 21 ġurnata wara l-ewwel doża (66.7 % fi 12-il individwu b'età minn 6 xhur sa 11-il xahar, 91.7 % fi 12-il individwu b'età minn 12-il xahar sa 23 xahar u 83.3 % fi 12-il individwu b'età minn 24 xahar sa 35 xahar).
English: Tel.: + 48 (22) 576 9000
Maltese: GSK Commercial Sp. z o.o. Tel.: + 48 (22) 576 9000
English: This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.
Maltese: Dan il-prodott mediċinali fih anqas minn 1mmol ta' sodium (23 mg) u anqas minn 1 mmol ta' potassium (39 mg) f'kull doża, i.e. essenzjalment huwa mingħajr sodium u potassium.
English: How to store Arepanrix
Maltese: X'fih Arepanrix
English: • Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
Maltese: Disturbi newroloġiċi bħal enkefalomajlite (fjammazzjoni tas-sistema nervuża ċentrali), nevrite (infjammazzjoni tan-nervituri) u tip ta' paraliżi magħrufa bħala Sindrome ta' Guillain-Barré
English: The Applicant/MAH commits not to release lots prepared using the extended formulation/fill process until the relevant validation data have been submitted and approved (RR#7Q5)
Maltese: L-Applikant/MAH jikkommetti ruħu li ma jpoġġix fuq issuq lottijiet ippreparati permezz tal-formulazzjoni estiża/proċess ta' mili sakemm ma tiġix ippreżentata u approvata dejta ta' validazzjoni rilevanti (RR#7Q5)
English: The immune response to Fluarix was satisfactory.
Maltese: Ir-rispons immuni għal Fluarix kien sodisfaċenti.
English: A dose (0.25 ml) of the vaccine will be given.
Maltese: Se tingħata doża (0.25 ml) tal-vaċċin.
English: Immune response to A/Vietnam/1194/2004
Maltese: Rispons immuni għal A/Vietnam/1194/2004 Ġurnata 21 N=145
English: Loss of appetite
Maltese: Telf ta' aptit
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 tilqim għall-influwenza, jistgħu jinkisbu riżultati pożittivi foloz f'testijiet seroloġiċi bl-użu talmetodu ELISA għal antikorpi għall-virus-1 ta' l-immunodefiċjenza umana (HIV-1), ta' l-epatite Ċ u speċjalment ta' l-HTLV-1.
English: N=17
Maltese: N=17 N = 17
English: AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
Maltese: AS03 stimulant magħmul minn squalene, DL-α-tocopherol u polysorbate 80 * emagglutinina
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
Maltese: - żewġ pakketti ta' 25 kunjett (ħġieġ tat-tip I) ta' 2.5 ml emulsjoni b'tapp (butyl rubber).
English: Conversely the combination of a range of doses of H5N1 antigen with AS03 adjuvant was able to protect against mortality and to reduce lung virus loads and viral shedding after intra-tracheal challenge with a homologous wild type H5N1 virus.
Maltese: Bilkontra, wara sfida intra-trakejali b'virus H5N1 omologu tat-tip selvaġġ, it-taħlita ta' firxa ta' dożi ta' lantiġen H5N1 ma' l-istimulant AS03 kienet kapaċi tipproteġi kontra l-mortalità u tnaqqas il-viral loads u t-tixrid tal-virus.
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Maltese: • pakkett wieħed li fih 50 kunjett ta' suspensjoni ta' 2.5 ml (antiġen)
English: Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Maltese: Għaraq Deni > 38°C Deni > 39°C Dijarea
English: Control groups included ferrets immunized with adjuvant alone and non-adjuvanted vaccine (7.5 micrograms HA).
Maltese: Il-gruppi ta' kontroll inkluda inmsa mlaqqma b'stimulant biss u b'vaċċin mhux stimulat (7.5 mikrogramma ta' HA).
English: Not applicable.
Maltese: Ma japplikax.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
Maltese: U KWANTITATTIVA Wara li titħallat, doża 1 (0.5 ml) ikun fiha:
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Maltese: Pakkett wieħed fih: - pakkett wieħed ta' 50 kunjett (ħġieġ tat-tip I) ta' 2.5 ml suspenjoni b'tapp (butyl rubber).
English: The side effects listed below have occurred during post-marketing surveillance with a similar vaccine (H1N1).
Maltese: L-effetti sekondarji elenkati taħt seħħew waqt s-sorveljanza ta' wara t-tqegħid fis-suq b'vaċċin simili (H1N1).
English: The Applicant/MAH commits to set a maximum decrease of 20% of HA content for the Drug Substance and to review when data for H1N1 become available.
Maltese: massimu ta' 20% ta' kontenut ta' HA għas-Sustanza Mediċinali u li jirrevedi meta ssir disponibbli dejta dwar H1N1.
English: In such cases, the Western blot method is negative.
Maltese: F'każijiet bħal dawn il-metodu Western blot huwa negattiv.
English: Non-clinical data obtained with a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Maltese: Informazzjoni li mhix klinka ottenuta minn verżjoni ta' Arepanrix li fiha 3.75 µg ta' HA derivat minn A/Indonesia/05/2005 (H5N1) magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku akut u minn dożi ripetuti, tolleranza lokali, effett tossiku fuq il-fertilità tal-mara, fuq l-embriju u l-fetu u wara t-twelid (sa tmiem il-perijodu ta' treddiegħ) ma turi l-ebda periklu speċjali għallbnedmin.
English: Fever (≥38°C) axillary Fever (≥39°C) axillary Drowsiness Irritability
Maltese: Deni (≥38°C) taħt id-driegħ Deni (≥39°C) taħt id-driegħ Ħedla
English: Arepanrix consists of two containers:
Maltese: Arepanrix jikkonsisti f'żewġ kontenituri:
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: Komuni ħafna (jaffettwaw aktar minn individwu 1 minn 10) Komuni (jaffettwaw minn 1 sa 10 individwi f'100) Mhux komuni (jaffettwaw minn 1 sa 10 individwi f'1000) Rari (jaffettwaw minn 1 sa 10 individwi f'10,000) Rari ħafna (jaffettwaw anqas minn individwu f'10,000)
English: Suspension and emulsion for emulsion for injection.
Maltese: Suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni.
English: See section 6.5 for the number of doses per vial.
Maltese: Ara sezzjoni 6.5 għan-numru ta' dożi li fih kull kunjett.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension and emulsion for emulsion for injection 50 vials: suspension (antigen)
Maltese: U KONTENUT Suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni 50 kunjett: suspensjoni (antiġen)
English: Immune system disorders Anaphylaxis, allergic reactions
Maltese: Disturbi fis-sistema immuni Anafilassi, reazzjonijiet allerġiċi
English: The MAH shall submit on a monthly basis a simplified periodic safety update report with the timelines, format and content as defined in the CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine (EMEA/359381/2009) and any subsequent update.
Maltese: L-MAH jissottometti kull xahar rapport simplifikat perjodiku dwar aġġornament ta' sigurta' biż-zmienijiet stipulati, format u kontenut kif definit fir-Rakkomandazzjonijiet għal Pjan ta' Farmakoviġilanza tas-CHMP bħala parti mill-Pjan għall-Imaniġġjar tar-Riskju li se jkun sottomess ma' l-Applikazzjoni għat-Tqegħid fis-Suq għall-Vaċċin ta' l-Influwenza Pandemika (EMEA/359381/2009) u kull aġġornament li jiġi wara.
English: • Adjuvant:
Maltese: • Stimulant:
English: In this leaflet:
Maltese: U wkoll minn:
English: Animal studies with Arepanrix do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali b'Arepanrix ma jindikawx tossiċita fis-sistema ripproduttiva (ara sezzjoni 5.3).
English: Seroconversion rate2
Maltese: Rata ta' serokonverżjoni2
English: It should be noted that the adverse reactions may be intensified.
Maltese: Għandu jkun innotat li r-reazzjonijiet avversi jistgħu jkunu aktar qawwija.
English: Split influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75 micrograms** per 0.5 ml dose *propagated in eggs ** expressed in microgram haemagglutinin
Maltese: Virus tal-influwenza maqsum, inattivat, li fih antiġen* ekwivalenti għal: Razza (X-179A) li tixbaħ lil A/California/7/2009 (H1N1)v 3.75 mikrogrammi għal kull doża ta' 0.5ml *propogat fil-bajd **espress bħala mikrogrammi ta'emaglutinina
English: Timelines described in the RMP
Maltese: Limitu ta' ħin deskritt fl-RMP
English: Immune response to A/California/7/2009 (H1N1)v-like D-Pan H1N1-007
Maltese: Rispons immuni għal razza tixbaħ lil A/California/7/2009 (H1N1)v D-Pan H1N1-007
English: Common: nausea, diarrhoea
Maltese: Komuni: tqalligħ, dijarea
English: In children aged 6-35 months who received a half of the adult dose (0.25 ml) of a similar vaccine (H1N1), fever and irritability occurred more often compared to the children 3-9 years who received a half of the adult dose (0.25 ml) of a similar vaccine (H5N1).
Maltese: Fi tfal b'età minn 6 xhur sa 35 xahar li rċevew nofs id-doża ta' l-adulti (0.25 ml) ta' vaċċin simili, deni u irritabilità seħħew b'mod aktar frekwenti meta mqabbel ma' tfal b'età minn 3 sa 9 snin li rċevew nofs id-doża ta' l-adulti (0.25 ml) ta' vaċċin simili (H5N1).
English: Emulsion vial:
Maltese: Kunjett ta' l-emulsjoni:
English: Clinical studies with a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) provide additional safety and immunogenicity data in healthy adults, including the elderly.
Maltese: Studji kliniċi b'verżjoni ta' Arepanrix li fih 3.75 µg HA derivati minn A/Indonesia/05/2005 (H5N1) jipprovdu dejta ta' sigurtà u immunoġeniċità addizzjonali f'adulti b'saħħithom inkluż l-anzjani.
English: One dose of 0.25 ml at an elected date.
Maltese: Doża waħda ta' 0.25 ml f'data magħżula.
English: The Applicant/MAH commits to provide abridged report for the following study performed in children Study Q-Pan H1N1-031 (9-17 yrs, Safety/ Immunogenicity) - abridged report for post dose 1 & post dose 2 (immuno & solicited and unsolicited symptoms, SAEs )
Maltese: Studju Q-Pan H1N1-031 (9-17 sena, Sigurtà/ Immunoġeniċità) - rapport imqassar ta' wara doża 1 u wara doża 2 (immunità u sintomi mitluba u mhux mitluba, SAEs)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kontenut:AS03 stimulant magħmul minn squalene (10.69 milligrammi), DL-α-tocopherol (11.86 milligrammi) u polysorbate 80 (4.86 milligrammi)
English: If they persist, CONSULT YOUR DOCTOR.
Maltese: Jekk jippersistu, IKKONSULTA
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Biologicals, Rixensart - Belgium
Maltese: GSK Biologicals, Rixensart - Il-Belġju
English: D-Pan H1N1-008
Maltese: Arepanrix (H1N1)
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
Maltese: • żewġ pakketti li fihom 25 kunjett ta' emulsjoni ta' 2.5 ml (stimulant)
English: In a clinical study in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) were as follows:
Maltese: Fi studju kliniku fi tfal b'saħħithom b'età minn 6 xhur sa 35 xahar (imqassma fi gruppi b'età minn 6 sa 11, 12 sa 23 u 24-35 xahar) ir-rispons ta' l-antikorp anti-HA 21 ġurnata wara l-ewwel u t-tieni nofs doża ta' l-adulti (i.e. 0.25 ml) kien kif ġej:
English: The frequency of possible side effects listed below is defined using the following convention:
Maltese: Il-frekwenza ta' effetti mhux mixtieqa possibli imniżżla hawn taħt hija definita skont il-konvenzjoni li ġejja :