FrancophonIA/ELRC3.0 huggingface dataset:
English: - The active substance is:
Maltese: - Sustanza attiva:
English: 9.75 milligrams polysorbate 80
Maltese: 9.75 milligrammi polysorbate 80
English: Packs of 10.
Maltese: Pakketti ta' 10.
English: 1.175 milligrams sorbitan trioleate
Maltese: 1.175 milligrammi sorbitan trioleate
English: Loc. Bellaria - 53018 Rosia - Sovicille (SI) Italy
Maltese: Bellaria - 53018 Rosia - Sovicille (SI) L-Italja
English: Systemic
Maltese: Sistemika
English: Adults (18-60 years):
Maltese: Adulti (18-60 sena):
English: Fever ≥ 40° C
Maltese: Deni ≥ 40° C
English: Elderly (>60 years):
Maltese: Anzjani (>60 sena):
English: Injection 2
Maltese: Injezzjoni 2
English: 1.175 milligrams
Maltese: 1.175 milligrammi
English: Adjuvant MF59C.1 containing: squalene
Maltese: Adjuvant MF59C.1 li fih squalene
English: Packs of 1 and 10.
Maltese: Pakketti ta' 1 u 10.
English: (Manufacturer responsible for final filtration of monovalent pooled harvest): Novartis Vaccines and Diagnostics S.r.l.
Maltese: (Manifattur responsabbli għall-filtrazzjoni finali ta' monovalent pooled harvest): Novartis Vaccines and Diagnostics S.r.l.
English: Rare (1/10,000 to <1/1,000),
Maltese: Rari (1/10,000 sa <1/1,000),
English: 0.05 milligrams
Maltese: 0.05 milligrammi
English: MF59C.1 is an oil/water emulsion containing 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg sorbitan trioleate in a citrate buffer.
Maltese: MF59C.1 huwa emulsjoni taż-żejt/ilma li fih 9.75 mg squalene, 1.175 mg polysorbate 80 u 1.175 mg sorbitan trioleate f'buffer ta' citrate.
English: Palpitation, tachycardia.
Maltese: Palpitazzjoni, takikardija.
English: Adolescents (9 to 17 years of age)
Maltese: Adoloxxenti (9 sa 17-il sena)
English: Common (1/100 to <1/10)
Maltese: Komuni (1/100 sa <1/10)
English: Respiratory disorders Cough.
Maltese: Disturbi respiratorji Sogħla.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12 August 2010
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI 12 ta' Awwissu 2010
English: Common: arthralgia
Maltese: Komuni: artralġja
English: Local
Maltese: Lokali
English: Rare: anaphylaxis
Maltese: Rari: anafilassi
English: BATCH NUMBER Lot:
Maltese: NUMRU TAL-LOTT Lot
English: In clinical trial 131 adults and 123 elderly were exposed to two doses of the 7.5 µg Focetria.
Maltese: Fi prova klinika, 131 adult u 123 anzjan ġew esposti għal żewġ dożi ta' 7.5 µg Focetria.
English: Seroprotection rate (95% CI)
Maltese: Rata ta' seroprotezzjoni (95% CI)
English: For the adjuvant, see section 2.
Maltese: Għas-sustanza adjuvanti, ara sezzjoni 2.
English: 7.5 micrograms** per 0.5 ml dose
Maltese: 7.5 mikrogrami** kull 0.5 ml doża
English: - Adjuvant:
Maltese: - Sustanza adjuvanti:
English: Fever 39°C to 39.9°C
Maltese: Deni 39°C sa 39.9°C
English: 10 x 10 doses of 0.5 ml vaccine (5 ml)
Maltese: 10 x 10 dożi ta' vaċċin ta' 0.5 ml (5 ml)
English: Uncommon (1/1,000 to <1/100),
Maltese: Mhux komuni (1/1,000 sa <1/100),
English: Focetria H1N1v
Maltese: H1N1v
English: Italy.
Maltese: L-Italja.
English: Any other AE
Maltese: Kwalunkwe AE ieħor
English: 5.0 ml in 10-dose vial (type I glass) with stopper (halo-butyl rubber).
Maltese: 5.0 ml f'kunjett ta' 10 dożi (ħġieġ ta' tip I) bi stopper (lastku halo-butyl).
English: Prophylaxis of influenza caused by A (H1N1v) 2009 virus (see section 4.4).
Maltese: Profilassi tal-influwenza kkawżata mill-virus A (H1N1v) tal-2009 (ara sezzjoni 4.4).
English: Muscoskeletal, connective tissue and bone disorders Very common: myalgia
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Komuni ħafna: mijalġija
English: Fever ≥38°C to 38.9°C
Maltese: Deni ≥ 38°C sa 38.9°C
English: Focetria is a vaccine to prevent influenza (flu) caused by A(H1N1v) 2009 virus.
Maltese: Focetria huwa vaċċin kontra l-influwenza mill-virus A (H1N1v) tal-2009.
English: Children and adolescents 3-17 years of age:
Maltese: Tfal u adolexxenti ta' bejn 3-17-il sena:
English: Fertility An animal study with H5N1 mock-up vaccine did not indicate reproductive toxicity (see section 5.3).
Maltese: Fertilità Studju fuq il-bhejjem b'vaċċin mock-up H5N1 ma weriex effetti ta' tossiċità riproduttiva (ara sezzjoni 5.3).
English: In such cases, the Western Blot method is negative.
Maltese: F'każijiet bħal dawn il-metodu tal-Western Blot hu negattiv.
English: GMR (95% CI) Seroconversion or Significant Increase (95% CI)
Maltese: GMR (95% CI) Serokonverżjoni jew Żieda Sinifikanti (95% CI)
English: Vasculitis with transient renal involvement and exudative erythema multiforme.
Maltese: Vaskulite b'involviment renali temporanju u eritema multiformi li tnixxi.
English: Fever ≥ 38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C
Maltese: Deni ≥ 38°C sa 38.9°C Deni 39°C sa 39.9°C Deni ≥ 40° C
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
Maltese: Disturbi newroloġiċi bħal enċefalomajelite (infjammazzjoni tas-sistema nervuża ċentrali) u tip ta' paralisi magħrufa bħala s-Sindrome ta' Guillain-Barré.
English: Nervous system disorders Very common: headache Rare: convulsions
Maltese: Disturbi fis-sistema nervuża Komuni ħafna: uġigħ ta' ras Rari: konvulżjonijiet
English: In clinical trials with different formulations (H5N3, H9N2 and H5N1) approximately 3400 subjects were exposed to the mock-up vaccines.
Maltese: Fi provi kliniċi b'fomulazzjonijiet differenti (H5N3, H9N2 u H5N1) madwar 3400 individwu kienu esposti għall-vaċċin mock-up.
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer.
Maltese: MF59C.1 emulsjoni ta' żejt fl-ilma li fiha squalene, bħala l-fażi taż-żejt, stabilizzat bi polysorbate 80 u sorbitan trioleate f'bafer ta' ċitrat.
English: Headache, dizziness, somnolence, syncope.
Maltese: Uġigħ ta' ras, sturdament, ħedla, sinkope.
English: Clinical trials with Focetria H1N1v
Maltese: Provi kliniċi b'Focetria H1N1v
English: Loc. Bellaria
Maltese: Bellaria
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 kontra l-influwenza, kienu osservati riżultati seroloġiċi pożittivi foloz miksuba bil-metodu ELISA għal antikorp tal-virus-1 ta' immunodefiċjenza umana (HIV-1), epatite Ċ u, speċjalment HTLV-1.
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, hu possibbli li jistgħu jseħħu reazzjonijiet ta' sensitizzazzjoni (ara sezzjoni 4.4).
English: No data are available in children aged less than 6 months (see sections 4.8 and 5.1).
Maltese: M'hemmx dejta minn tfal ta' inqas minn 6 xhur (ara sezzjonijiet 4.8 u 5.1).
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: • Każijiet avversi li għandhom jiġu prijoritizzati biex jiġu rapportati, i.e. reazzjonijiet avversi fatali u ta' periklu għal ħajja, reazzjonijiet avversi severi mhux mistennija, reazzjonijiet avversi ta' interess speċjali (AESI).
English: The safety profile of Focetria was similar to that of the H5N1 mock up vaccines.
Maltese: Il-profil tas-sigurtà ta' Focteria kien simili għal dak tal-vaċċini mock-up H5N1.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website tal-Aġenzija Ewropea dwar il-Mediċini (EMA): http://www.ema.europa.eu/.
English: 1 x single dose of 0.5 ml pre-filled syringe 10 x single dose of 0.5 ml pre-filled syringes
Maltese: 1 x siringa mimlija għal-lest ta' doża waħda ta' 0.5 ml 10 x siringi mimlijin għal-lest ta' doża waħda ta' 0.5 ml
English: Influenza vaccine, ATC Code: J07BB02
Maltese: J07BB02
English: One dose of 0.5 ml contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, and adjuvanted with MF59C.1, of strain:
Maltese: Doża waħda ta' 0.5 ml fiha: Sustanzi Attivi: Antiġeni tal-wiċċ tal-virus tal-influwenza (emaglutinin u neuraminidase), propagati fil-bajd, u b'MF59C.1 bħala adjuvant tar-razza:
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: H1N1v to healthy children and adolescents aged 6 months-17 years and to healthy adults,
Maltese: H1N1v lil tfal u adoloxxenti b'saħħithom ta' bejn 6 xhur u 17-il sena u għal adulti
English: Data on co-administration of Focetria H1N1v with a non-adjuvanted seasonal influenza subunit vaccine in healthy adults aged 18-60 years of age did not suggest any interference in the immune response to Focetria.
Maltese: H1N1v b'vaċċin ta' sottounità ta' influwenza staġjonali mhux adjuvantat f'adulti ta' bejn 18 u 60 sena ma ssuġġerixxiex xi interferenza fir-rispons immunitarju għal Focteria.
English: Neurological disorders, such as encephalomyelitis and Guillain Barré syndrome.
Maltese: Mard newroloġiku, bħal enċefalomajelite u s-sindrome ta' Guillain Barré.
English: Additional information is available from the studies conducted with a vaccine similar in composition to Focetria but containing antigen derived from H5N1 viruses.
Maltese: Teżisti informazzjoni addizzjonali mill-istudji mwettqa b'vaċċin simili fil-kompożizzjoni għal Focetria iżda li fih antiġen derivate minn virus H5N1.
English: Via Fiorentina, 1 - Siena, Italy.
Maltese: Novartis Vaccines and Diagnostics S.r.l. - Via Fiorentina, 1 - Siena, L-Italja.
English: Adverse reactions in the week following vaccination from 80 infants 6-11 months old and 82 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
Maltese: Reazzjonijiet avversi fil-ġimgħa ta' wara t-tilqima minn 80 tarbija ta' bejn 6-11-il xahar u 82 tarbija li telqu jimxu ta' bejn 12-35 xahar, li rċevew il-formulazzjoni ta' 7.5 µg, ġew irrappurtati kif ġej:
English: Cardiac disorders Palpitation, tachycardia.
Maltese: Disturbi fil-qalb Palpitazzjoni, takikardija.
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Maltese: Barra mir-reazzjonijiet avversi rrapportati fil-provi kliniċi, dawn li ġejjin ġew irrapportati matul esperjenza ta' wara t-tqegħid fis-suq b'Focetria H1N1v:
English: Gastrointestinal disorders Common: nausea
Maltese: Disturbi gastrointestinali Komuni: dardir
English: The vaccine contains an ‘adjuvant' (MF59C.1) to stimulate a better response.
Maltese: Il-vaċċin fih ‘sustanza adjuvanti' (MF59C.1) biex jistimula rispons aħjar.
English: The incidence of symptoms observed in subjects over 60 years of age was generally lower as compared to the 18-60 years old population.
Maltese: L-inċidenza tas-sintomi osservati fis-suġġetti ta' aktar minn 60 sena kienet ġeneralment inqas meta mqabbla mal-popolazzjoni ta' 18-60 sena.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181
Maltese: Razza derivata minn A/California/07/2009 (H1N1) użat NYMC (X-181)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/004
Maltese: FIS-SUQ EU/1/07/385/004
English: Paediatric population Children and adolescents 6 months to 17 years of age
Maltese: Tfal u adolexxenti bejn is-6 xhur sa 17-il sena.
English: Very common reactions reported in 233 infants and toddlers 6 to 35 months of age:
Maltese: Reazzjonijiet komuni ħafna rrapportati f'233 tarbija u trabi li telqu jimxu ta' bejn 6 u 35 xahar:
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Maltese: • Meta tiġi riċevuta informazzjoni ġdida li jista' jkollha impatt fuq l-Ispeċifikazzjoni tasSigurtà kurrenti, Pjan ta' Farmakoviġilanza jew attivitajiet tal-minimizzazzjoni tar-riskji
English: A protective response may not be elicited in all vaccinees (see section 5.1).
Maltese: Mhux kull persuna vvaċċinata jista' jkollha rispons protettiv (ara sezzjoni 5.1).
English: Seronegative at baseline N=51
Maltese: Seronegattivi fil-linja bażi N=51
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems), exudative erythema multiforme.
Maltese: Vaskulite (infjammazzjoni tal-vini li tista' tikkawża raxxijiet tal-ġilda, uġigħ fil-ġogi u problemi fil-kliewi), eritema multiforme bit-tnixxija.
English: Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C (36° and 46° F).
Maltese: Bejn użu u ieħor, erġa' poġġi l-kunjett b'aktar minn doża waħda fil-kundizzjonijiet ta' ħżin rakkomandati ta' bejn 2° u 8° C (36° u 46° F).
English: Common: injection site ecchymosis and fever Uncommon: influenza like illness Rare: anaphylaxis
Maltese: Mhux komuni: mard simili għall-influwenza Rari: anafilassi
English: Excipients: thiomersal
Maltese: Sustanzi mhux attivi: thiomersal
English: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Maltese: Disturbi gastrointestinali Disturbi gastrointestinali bħal dardir, rimettar, uġigħ addominali u dijarrea.
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Maltese: * propogat fil-bajd ** mfisser f'mikrogrammi ta' emaglutinin
English: The physician should inform you about the possibility to experience convulsion, in particular if you have had previous history of epilepsy.
Maltese: Xi każijiet ġew osservati f'individwi bi storja medika ta' epilessija.
English: Seronegative at baseline N=48
Maltese: Seronegattivi fil-linja bażi N=48
English: Lymphadenopathy.
Maltese: Limfadenopatija.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/001
Maltese: FIS-SUQ EU/1/07/385/001
English: Clinical studies with Focetria H1N1v currently provide:
Maltese: Studji kliniċi b'Focetria H1N1v fil-preżent jipprovdu:
English: Generalised skin reactions including itching, urticaria (hives), rash or swelling of the skin and mucous membranes.
Maltese: Reazzjonijiet ġeneralizzati tal-ġilda inkluż ħakk, urtikarja (ħorriqija), raxx jew nefħa tal-ġilda u tal-membrani mukużi.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA
English: Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Maltese: Vaċċin kontra l-Influwenza H1N1v (antiġeni tal-wiċċ, inattivati, adjuvanati)
English: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Maltese: Sensibilità, eritema, irritabilità, biki mhux normali, ħedla, dijarea u bidla fid-drawwiet ta' kif jieklu.
English: Take special care with Focetria:
Maltese: M'għandekx tirċievi Focetria:
English: Very rare (<1/10,000).
Maltese: Rari ħafna (<1/10,000).
English: Pharmacotherapeutic group: Vaccines.
Maltese: Kategorija farmakoterapewtika:
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Maltese: Reazzjonijiet allerġiċi, anafilassi inkluż dispnea, bronkospażmu, edema larinġeali, li f'każijiet rari jwasslu għal xokk.
English: Uncommon: influenza like illness
Maltese: Mhux komuni: mard simili għall-influwenza
English: GMR (95% CI) Seroconversion or Significant Increase (95% CI) * measured by HI assay ** geometric mean ratios of HI
Maltese: Sinifikanti (95% CI) * imkejla b'assaġġ HI ** proporzjonijiet ġeometriċi medji ta' HI
English: Seronegative at baseline N=46
Maltese: Seronegattivi fil-linja bażi N=46
English: The use of a second 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 fis-sezzjonijiet 4.4, 4.8 u 5
English: Children (3-8 years)
Maltese: Tfal (3 sa 8 snin)
English: Seronegative at baseline N=45
Maltese: Seronegattivi fil-linja bażi N=45
English: Seronegative at baseline N=25
Maltese: Seronegattivi fil-linja bażi N=25
English: How to store Focetria
Maltese: X'fih Focetria
English: Seronegative at baseline N=37
Maltese: Seronegattivi fil-linja bażi N=37
English: In addition, from Post-marketing surveillance with seasonal trivalent vaccines in all age groups and with the MF59 adjuvanted seasonal trivalent vaccine with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), licensed for use in elderly subjects above 65 years of age, the following adverse events have been reported:
Maltese: Barra minn hekk, minn sorveljanza ta' wara t-tqegħid fis-suq b'vaċċini trivalenti staġjonali fil-gruppi tal-etajiet kollha u b'vaċċini trivalenti staġjonali adjuvanti MF59, bil-kompożizzjoni simili għal Focetria (antiġen tal-wiċċ, inattivat, b'MF59C.1 bħala adjuvant), awtorizzat biex jintuża fl-anzjani li għandhom 'il fuq minn 65 sena kienu rrapportati l-episodji avversi li ġejjin:
English: Seroconversion or Significant Increase (95% CI) * measured by HI assay ** geometric mean ratios of HI
Maltese: Żieda Sinifikanti (95% CI) * imkejla b'assaġġ HI ** proporzjonijiet ġeometriċi medji ta' HI
English: This medicinal contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium free.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodju (23 mg) u inqas minn 1 mmol ta' potassju (39 mg) għal kull doża ta' 0.5 ml, jiġifieri, essenzjalment hija ħielsa minn sodju u potassju
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 319 to 702 (N=70) and an increase in GMT from 247 to 726 in children who were seronegative at baseline (N=48).
Maltese: Tagħrif fuq rispons għal tieni doża mogħtija wara intervall ta' tliet ġimgħat wera żieda fil-GMT totali minn 319 għal 702 (N=70) u żieda fil-GMT minn 247 għal 726 fi tfal li kienu seronegattivi fil-linja bażi (N=48).
English: Blood and lymphatic system disorders Lymphadenopathy.
Maltese: Disturbi tad-demm u tas-sistema limfatika Limfadenopatija.
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 793 to 1065 (N=88) and an increase in GMT from 522 to 870 in children who were seronegative at baseline (N=51).
Maltese: Tagħrif fuq rispons għal tieni doża mogħtija wara intervall ta' tliet ġimgħat wera żieda fil-GMT totali minn 793 għal 1065 (N=88) u żieda fil-GMT minn 522 għal 870 fi tfal li kienu seronegattivi fil-linja bażi (N=51).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (5 ml)
Maltese: Kunjett ta' diversi dożi (5 ml)
English: 0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
Maltese: 0.5 ml f'siringa mimlija għal-lest (ħġieġ ta' tip I) bi planġer-stopper (lastku bromo-butyl).
English: (Manufacturer responsible for monovalent pooled harvests, before final filtration): Novartis Vaccines and Diagnostics S.r.l.
Maltese: (Manifattur responsabbli għal monovalent pooled harvests, qabel il-filtrazzjoni finali):
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 10-DOSE VIAL
Maltese: Żomm fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: Pre-filled syringe:
Maltese: Injezzjoni ġol-muskolu
English: Non-clinical data obtained with the mock-up vaccine (MF59C.1-adjuvanted H5N1 vaccine) and with seasonal vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of efficacy, repeated dose toxicity, and reproductive and developmental toxicity.
Maltese: Informazzjoni mhux klinika, miksuba bil-vaċċin mock-up (vaċċin H5N1 bl-adjuvant MF59C.1) u b'vaċċin staġjonali li fih l-adjuvant MF59C.1 ma wriet ebda periklu speċjali għall-umani fuq il-bażi ta' studji konvenzjonali dwar l-effikaċja, effett tossiku minn dożi ripetuti, effett tossiku fuq is-sistema riproduttiva, u żvilupp ma turi l-ebda periklu speċjali għall-bnedmin.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Maltese: It-tilqima għandha ssir permezz ta' injezzjoni intramuskolari preferibbilment fil-muskolu deltojdi jew fil-koxxa anterolaterali (skont il-massa muskolari).
English: The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
Maltese: L-inċidenza ta' sintomi osservati f'individwi li għandhom 'il fuq minn 60 sena kienet inqas meta mqabbla mal-popolazzjoni ta' bejn it-18 - 60 sena.
English: Focetria contains
Maltese: Focetria
English: The MAH shall perform the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use CHMP.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq jimpenja ruħu li jwettaq studji u attivitajiet addizzjonali ta' farmakoviġilanza, kif miftiehem fil-Pjan dwar l-Immaniġġjar tar-Riskju (RMP) ippreżentat f'Modulu 1.8.2 tal-Applikazzjoni għat-Tqegħid fis-Suq u kull aġġornament sussegwenti tal-Pjan tal-Immaniġġjar tar-Riskju miftiehem mis-CHMP.
English: Milky-white liquid.
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 307 to 873 (N=66) and an increase in GMT from 243 to 733 in children who were seronegative at baseline (N=45).
Maltese: Tagħrif fuq risponsi għal tieni doża mogħtija wara intervall ta' tliet ġimgħat wera żieda fil-GMT ġenerali minn 307 għal 873 (N=66) u żieda fil-GMT minn 243 għal 733 fi tfal li kienu seronegattivi fil-linja bażi (N=45).
English: Adult and Elderly
Maltese: Adulti u anzjani
English: Adverse reactions in the week following vaccination from 87 children 3-8 years old and 95 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
Maltese: Reazzjonijiet avversi fil-ġimgħa ta' wara t-tilqima minn 87 tifel u tifla ta' bejn 3-8 snin u 95 tifel u tifla u adoloxxenti ta' 9-17-il sena li rċevew il-formolazzjoni ta' 7.5 µg ġew irrapportati kif ġej.
English: Infants (6 to 11 months of age)
Maltese: Trabi (6 sa 11-il xahar)
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.
Maltese: Razza derivata minn A/California/07/2009 (H1N1)
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Maltese: Is-CHMP jaqbel mal-konklużjonijiet xjentifiċi li saru mill-PRAC.
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal (only for the multidose vial presentation), to egg and, chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
Maltese: • jekk kellek reazzjoni allerġika li mhix reazzjoni allerġika f'daqqa u li hi ta' periklu għal ħajja għal xi sustanza li tinsab fil-vaċċin, għal thiomersal (li jinsab biss fil-preżentazzjoni ta' kunjett ta' diversi dożi), għal proteini tal-bajd u tat-tiġieġ, għal ovalbumun, għal formaldehyde, kanamycin u neomycin sulphate (antibijotiċi) jew cetyltrimethylammonium bromide (CTAB) (ara sezzjoni 6, Aktar Tagħrif).
English: Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Maltese: Il-biċċa l-kbira tar-reazzjonijiet kienu ta' natura ħafifa, damu żmien qasir u kienu kwalitattivament simili għal dawk ikkawżati minn vaċċini konvenzjonali kontra l-influwenza staġjonali.