FrancophonIA/ELRC3.0 huggingface dataset:
English: In rare instances, phimosis was reported and sometimes circumcision was performed (see section 4.4).
Maltese: F'każijiet rari, ġiet irrappurtata fimosi u xi drabi saret ċirkonċiżjoni (ara sezzjoni 4.4).
English: For patients who are tolerating a Vokanamet dose containing canagliflozin 50 mg who need tighter glycemic control, the dose can be increased to Vokanamet containing 150 mg canagliflozin twice daily (see below and section 4.4).
Maltese: F'pazjenti li jkunu qed jittolleraw doża ta' Vokanamet li fiha canagliflozin 50 mg u għandhom bżonn kontroll gliċemiku iktar strett, id-doża tista' tiżdied għal Vokanamet li fih 150 mg canagliflozin darbtejn kuljum (ara taħt u sezzjoni 4.4).
English: The tablet is beige, capsule-shaped, 21 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “551” on the other side.
Maltese: Il-pillola hija ‘beige', għamla ta' kapsula, b'tul ta' 21 mm, terħi l-mediċina b'mod immedjat, miksija b'rita, u mnaqqxa b'“CM” fuq naħa waħda u “551” fuq in-naħa l-oħra.
English: • blood tests may show increases in your blood phosphate level
Maltese: • rari ħafna: tnaqqis fil-livelli ta' vitamina
English: After 104 weeks of treatment, canagliflozin did not adversely affect bone mineral density.
Maltese: Wara 104 ġimgħat ta' kura, canagliflozin m'affettwax id-densita tal-minerali tal-għadam b'mod avvers.
English: In two studies conducted in special populations (older patients and patients with or at high risk for cardiovascular disease), canagliflozin was added to patients' current stable diabetes treatments (diet, monotherapy, or combination therapy).
Maltese: F'żewġ studji li saru f'popolazzjonijiet speċjali (pazjenti akbar fl-età u pazjenti b'mard kardjovaskulari jew riskju akbar ta' mard kardjovaskulari), canagliflozin żdied mal-kuri stabbli attwali tad-dijabete talpazjenti (dieta, monoterapija, jew terapija kkombinata).
English: 24 to 35 months 1st dose 2nd dose 1st dose 2nd dose
Maltese: 24 sa 35 xahar 1 doża 2 doża 1 doża 2 doża
English: For instructions for preparation, see section 6.6.
Maltese: Għal istruzzjonijiet dwar il-preparazzjoni, ara sezzjoni 6.6.
English: Adults 18 to 60 years of age Total enrolled subjects N= 99
Maltese: Adulti 18 sa 60 sena Total ta' persuni rreġistrati N= 99
English: For adjuvant, see section 2.
Maltese: Għall-adjuvant, ara sezzjoni 2.
English: Tel.: +420 233 086 387 Tel: +420 233 086 111
Maltese: +420 233 086 387 Tel: +420 233 086 111
English: Clinical
Maltese: Kliniku
English: Elderly 71 to 80 years of age
Maltese: Anzjani minn 71 sa 80 sena
English: Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l'Etoile France
Maltese: Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l'Etoile Franza
English: Elderly (>60 years of age):
Maltese: Anzjani (>60 sena):
English: Adolescents (N=49) 9 to 17 years of age
Maltese: Adolexxenti (N=49) minn 9 sa 17-il sena
English: After mixing: - Active substance:
Maltese: - Sustanza attiva:
English: 2nd dose
Maltese: 2 doża
English: Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1).
Maltese: Profilassi tal-influwenza f'sitwazzjoni pandemika li tkun uffiċjalment iddikjarata (ara sezzjonijiet 4.2 u 5.1).
English: 6 months.
Maltese: 6 xhur.
English: Excipients: The vaccine contains 11.3 micrograms thiomersal.
Maltese: It-tilqima fiha 11.3 mikrogramma ta' thiomersal.
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 sa <1/100) Rari (≥1/10,000 sa <1/1,000)
English: 4.5 ml After mixing with the antigen: 10 doses of 0.5 ml
Maltese: 4.5 ml Wara t-taħlit mal-antiġen: 10 dożi ta' 0.5 ml
English: Adults and elderly:
Maltese: Adulti u anzjani:
English: • Pain located on the nerve route (neuralgia),
Maltese: • Uġigħ lokalizzat fuq ir-rotta tan-nervaturi (nevralġija),
English: - Side effects related to the central nervous system:
Maltese: - Effetti sekondarji marbuta mas-sistema nervuża ċentrali:
English: 1st dose
Maltese: 1 doża
English: Pandemic influenza vaccine (H1N1)
Maltese: Tilqima kontra l-influwenza pandemika (H1N1)
English: Split influenza virus*, inactivated, containing antigen equivalent to:
Maltese: Virus tal-Influwenza maqsum*, inattivat, li fih antiġen ekwivalenti għal:
English: Adults (from 18 to 60 years of age):
Maltese: Persuni adulti (minn 18-il sena sa 60 sena):
English: The rate of grade 3 (severe) reactions was overall low (≤ 2%).
Maltese: Ir-rata ta' reazzjonijiet ta' grad 3 (severi) kienet globalment baxxa (≤ 2%).
English: In a clinical trial, the immunogenicity 21 days after each injection of HUMENZA given 21 days apart has been assessed in 54 elderly (29 elderly from 61 to 70 years of age, 18 elderly from 71 to 80 years of age and 7 elderly of 81 years of age and over).
Maltese: Fi prova klinika, l-immunoġeniċità 21 jum wara kull injezzjoni ta' HUMENZA li jingħata wara 21 ijiem ġiet evalwata f'54 persuna anzjana (29 anzjan ta' bejn 61 sa 70 sena, 18-il persuna anzjana ta' bejn 71 sa 80 sena, 7 persuni anzjani ta' 81 sena jew iżjed).
English: Total enrolled subjects N= 18
Maltese: Total ta' persuni rreġistrati N= 18
English: Injection site pain/tenderness Injection site erythema Injection site swelling Injection site induration Injection site ecchymosis
Maltese: Nefħa fis-sit tal-injezzjoni Indurazzjoni fis-sit tal-injezzjoni Injection site ecchymosis
English: Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain-Barré syndrome
Maltese: Nevralġija, parestesija, konvulżjonijiet bid-deni, disturbi newroloġiċi, bħal enċefalomajelite, nevrite u s-sindromu ta' Guillain Barré
English: Sanofi pasteur - Parc Industriel d'Incarville - F-27100 Val-de-Reuil - France Sanofi pasteur - Campus Mérieux - 1541, avenue Marcel Mérieux - F-69280 Marcy l'Etoile - France
Maltese: Val-de-Reuil - Franza Sanofi pasteur - Campus Mérieux - 1541, avenue Marcel Mérieux - F-69280 Marcy l'Etoile - Franza
English: Children (12 to 35 months of age)
Maltese: Tfal (minn 12 sa 35 xahar)
English: Total enrolled subjects N= 50
Maltese: Total ta' persuni rreġistrati N= 50
English: Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Maltese: Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Ilma għall-injezzjonijiet
English: Seronegative subjects prior to vaccination N= 55
Maltese: Persuni seronegattivi qabel it-tilqima N= 55
English: EXPIRY DATE EXP MM/YYYY
Maltese: DATA TA' META JISKADI EXP XX/SSSS
English: Children 3 to 8 years of age
Maltese: Tfal minn 3 sa 8 snin
English: * propagated in eggs ** expressed in microgram haemagglutinin
Maltese: * ippropagat fil-bajd ** espress f'mikrogrammi ta' emagglutinin
English: Total enrolled subjects N= 48
Maltese: Total ta' persuni rreġistrati N= 48
English: Total enrolled subjects N= 29
Maltese: Total ta' persuni rreġistrati N= 29
English: Four days after challenge, in the control group, 34% of the lungs were affected and presented lung lesions associated with high levels of virus replication in lung tissue (≥ 4.7 TCID50/g tissue).
Maltese: Erbat ijiem wara ċ-challenge, fil-grupp tal-kontroll, 34% tal-pulmun kien affettwat u kien hemm leżjonijiet pulmonari assoċjati ma' livelli għoljin ta' replikazzjoni virali fit-tessut pulmonari (≥ 4.7 TCID50/g tessut).
English: In such cases, the Western blot method is negative.
Maltese: F'każijiet bħal dawn, il-metodu Western blot jagħti riżultat negattiv.
English: The rate of grade 3 (severe) reactions was overall low (from 2 to 14% in children from 3 to 8 years of age and from 2 to 8.2% in adolescents from 9 to 17 years of age).
Maltese: (minn 2 sa 14 % fi tfal bejn 3 sa 8 snin u minn 2 sa 8.2% f'adolexxenti bejn 9 sa 17 snin).
English: Suspension for injection 10 vials
Maltese: Suspensjoni għall-injezzjoni 10 kunjetti
English: Suspension and emulsion for emulsion for injection 10 vials of suspension (antigen) 10 vials of emulsion (adjuvant)
Maltese: Suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni 10 kunjetti bis-suspensjoni (antiġen) 10 kunjetti bl-emulsjoni ((adjuvant)
English: Elderly 61 to 70 years of age
Maltese: Anzjani minn 61 sa 70 sena
English: HUMENZA has been given "conditional approval".
Maltese: HUMENZA ngħata “approvazzjoni b'kundizzjoni”.
English: In ferrets administered with one or two doses of HUMENZA, a significant reduction of lung damages (4 % or 1 % of affected lung, respectively) and of lung viral loads (more than 4 log10 reduction) was achieved resulting in 86% (6 out of 7 ferrets) or 100% of ferrets with no detectable virus in lungs, respectively.
Maltese: Fl-neminmsa li ngħataw doża waħda jew tnejn ta' HUMENZA, tnaqqis sinifikanti fil-ħsara fil-pulmun (4% jew 1% ta' pulmun affettwat, rispettivament) u ta' ammonti pulmonari virali (iktar minn tnaqqis ta' 4 log10) inkiseb, u dan irriżulta f'86% (6 minn 7 neminmsa) jew 100% tal-neminmsa mingħajr lebda virus li seta' jkun osservat fil-pulmun, rispettivament.
English: Four weeks after the last vaccine administration, ferrets were challenged with the wild type homologous strain A/H1N1/Netherlands/602/2009.
Maltese: Erba' ġimgħat wara l-aħħar għoti tat-tilqima, n-neminmsa kienu challenged bir-razza omologa wild type A/H1N1/Netherlands/602/2009.
English: Total enrolled subjects N= 49
Maltese: Total ta' persuni rreġistrati N= 49
English: The severity of the local and systemic reactions was mainly from grade 1 (mild) to grade 2 (moderate).
Maltese: Is-severità tar-reazzjonijiet lokali u sistemiċi kienet primarjament minn grad 1 (ħafifa) sa grad 2 (moderata).
English: In the different age groups, there are limited data (adults aged 18 to 60 years), very limited data (adults aged 61 years and over, children aged 6 months to 17 years) or no data (children aged less than 6 months) with HUMENZA as detailed in sections 4.4, 4.8 and 5.1.
Maltese: Fil-gruppi ta' eta differenti, hemm dejta limitata (adulti minn 18 sa 60 sena), dejta limita ħafna (adulti minn 61 snin ‘il fiq, tfal minn 6 xhur sa 17 il-sena) jew ebda dejta (tfal li għadhom m'għalqux 6 xhur) b'Humenza kif inhu iddetaljat fis-sezzjonijiet 4.4, 4.8 and 5.1.
English: * propagated in eggs ** haemagglutinin
Maltese: * ippropagat fil-bajd ** emaglutinin
English: Dispose of in accordance with local regulations.
Maltese: Armi b'mod konformi mar-regolamenti lokali.
English: Shivering Vomiting Abnormal crying Drowsiness Appetite lost Irritability
Maltese: Nuqqas t'aptit Irritabilità
English: Seroconversion factor*** [95% CI]
Maltese: Fattur ta' serokonverżjoni*** [95% CI]
English: - Allergic reactions:
Maltese: - Reazzjonijiet allerġiċi:
English: Emulsion for injection 10 vials
Maltese: Emulsjoni għall-injezzjoni 10 kunjetti
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 (EMA/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 tasCHMP 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 (EMA/359381/2009) u kull aġġornament li jiġi wara.
English: Total enrolled subjects N= 7
Maltese: Total ta' persuni rreġistrati N= 7
English: Groups of 7 ferrets were immunized intramuscularly (IM) with one human dose of HUMENZA (3.8 µg of HA and full dose AF03) (at D21) or 2-dose administration of one human dose at 3-week intervals (at D0 and D21) and compared to a control group (AF03 adjuvant diluted in PBS).
Maltese: Gruppi ta' 7 neminmsa kienu mlaqqma ġol-muskoli (IM) b'doża umana waħda ta' HUMENZA (3.8 µg ta' HA u doza sħiħa AF03) (f' Jum 21) jew għotja f'zewg dożi ta doża umana waħda f'intervalli ta' 3 ġimgħat (f'Jum 0 u f'Jum 21) u mqabbla ma' grupp tal-kontroll (AF03 adjuvant dilwit f'PBS).
English: Adolescents 9 to 17 years of age
Maltese: Adolexxenti: minn 9 sa 17-il sena
English: Seronegative subjects prior to vaccination N= 37
Maltese: Persuni seronegattivi qabel it-tilqima N= 37
English: Sanofi Aventis Romania SRL Tel.: +40 21 3047 463
Maltese: Romania SRL Tel.: +40 21 3047 463
English: Overall, reactions were more frequent in adults than in elderly and less frequent after the second dose in both age groups.
Maltese: Globalment, ir-reazzjonijiet kienu iktar frekwenti fl-adulti milli fl-anzjani u inqas frekwenti wara ttieni doża fiż-żewġ gruppi ta' età.
English: Children from 3 to 8 years old:
Maltese: Tfal minn 3 sa 8 snin:
English: The frequency of possible side effects listed below is defined using the following convention:
Maltese: Il-frekwenza tal-effetti sekondarji possibbli elenkati hawn taħt hi definita bl-użu tal-konvenzjoni li ġejja:
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 reazzjonijiet ta' sensibilizzazzjoni jistgħu jseħħu (ara sezzjoni 4.4).
English: Sanofi Pasteur SA 2, avenue Pont Pasteur 69007 Lyon - France
Maltese: Sanofi Pasteur SA 2, avenue Pont Pasteur 69007 Lyon - Franza
English: Seroprotection rate* % [95% CI]
Maltese: Rata ta' seroprotezzjoni* % [95% CI]
English: Sanofi Pasteur SA 2, avenue Pont Pasteur F-69007 Lyon France
Maltese: Sanofi Pasteur SA 2, avenue Pont Pasteur F-69007 Lyon Franza
English: Elderly above 60 years of age:
Maltese: Anzjani ta' iktar minn 60 sena:
English: Very common: appetite lost, irritability, drowsiness, fever, abnormal crying.
Maltese: Komuni ħafna: telf ta' aptit, irritabilità, ħedla, biki anormali.
English: Available non clinical data obtained with the vaccine HUMENZA or with the same vaccine but with another strain (A/H5N1) revealed no special hazard for humans based on conventional repeat dose toxicity studies, reproductive and developmental toxicity studies and an investigative pneumopathology study.
Maltese: Dejta mhux klinika disponibbli miksuba bit-tilqima HUMENZA jew bl-istess tilqima iżda b'razza oħra (A/H5N1), ma żvelat l-ebda periklu speċjali għall-bnedmin ibbażat fuq studji konvenzjonali ta' effett tossiku minn dożi ripetuti, studji dwar tossiċità riproduttiva u tal-iżvilupp, u studju ta' stħarriġ pnewmopatoloġiku.
English: In a clinical trial, the immunogenicity 21 days after each injection of HUMENZA given 21 days apart has been assessed in 99 adults.
Maltese: Fi prova klinika, l-immunoġeniċità 21 jum wara kull injezzjoni ta' HUMENZA li jingħata wara 21 ijiem ġiet evalwata f'99 persuna adulta.
English: AF03 adjuvant composed of squalene (33 mg), sorbitan oleate (4.9 mg), polyoxyethylene cetostearyl ether (6.3 mg), mannitol (6.1 mg) per 1 ml
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA AF03 adjuvant magħmul minn squalene (33 mg), sorbitan oleate (4.9 mg), polyoxyethylene cetostearyl ether (6.3 mg), mannitol (6.1 mg) f'kull 1 ml
English: Immunogenicity data obtained in a limited number of children aged 6-35 months show that there is a further immune response to a second half-dose of 0.25 ml administered after an interval of three weeks.
Maltese: Dejta dwar immunoġeniċità miksuba f'numbru limitata ta tfal ta' eta ta bejn 6-35 xhur juri li hemm rispons immuni addizzjonali jekk it-tieni doża ta' nofs it-tilqima ta' 0.25ml tingħata wara interval ta' tliet ġimgħat.
English: NAME OF THE MEDICINAL PRODUCT HUMENZA suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Maltese: HUMENZA suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni Tilqima kontra l-influwenza pandemika (H1N1) (virion maqsum, diżattivat, adjuvanted)
English: General disorders and administration site conditions - Very common: injection site pain - Common: malaise, shivering, fever, injection site reactions such as induration, erythema,
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata - Komuni ħafna: uġigħ fis-sit tal-injezzjoni - Komuni: telqa, rogħda, deni, reazzjonijiet fis-sit tal-injezzjoni bħala ebusija, eritema, nefħa,
English: EXP MM/YYYY
Maltese: EXP XX/SSSS
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus*, inactivated, containing antigen equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)..............................................................30 µg** For 1 ml
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Virus tal-Influwenza maqsum*, inattivat, li fih antiġen ekwivalenti għal: A/California/7/2009 (H1N1) bħal razza (NYMC X-179A).......................................................30 µg** Għal 1 ml
English: The other ingredients are: thiomersal (11.3 micrograms per 0.5 ml dose), sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Maltese: Is-sustanzi l-oħra huma: thiomersal (11.3 mikrogrammi f'kull doża ta' 0.5 ml), sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għallinjezzjonijiet.
English: Seroconversion rate** % [95% CI]
Maltese: Rata ta' serokonverżjoni** % [95% CI]
English: Adolescent from 9 to 17 years old:
Maltese: Adolexxenti: minn 9 snin sa 17-il sena:
English: One half-dose of 0.25 ml at an elected date.
Maltese: Nofs doża ta' 0.25 ml f'data magħżula.
English: Adjuvant vial:
Maltese: Wara t-taħlit:
English: Sanofi Pasteur SA - 2, avenue Pont Pasteur - F-69007 Lyon - France
Maltese: Sanofi Pasteur SA - 2, avenue Pont Pasteur - F-69007 Lyon - Franza
English: HUMENZA is a vaccine to prevent pandemic influenza (flu).
Maltese: HUMENZA hu tilqima biex tiġi evitata l-influwenza pandemika.
English: The rate of grade 3 (severe) reactions was overall low (from 6.5 to 8.3% in children from 6 to 11 months of age and from 8.3 to 12.5% in children from 12 to 35 months of age).
Maltese: (minn 6.5 sa 8.3% fi tfal ta'bejn 6 sa 11-il xahar u minn 8.2 sa 12.5% fi tfal ta' bejn 12-il xahar sa 35 xahar)
English: AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams)
Maltese: AF03 adjuvant hu magħmul minn squalene (12.4 milligrammi), sorbitan oleate (1 9 milligrammi), polyoxyethylene cetostearyl ether (2.4 milligrammi) u mannitol (2.3 milligrammi)
English: PHARMACOLOGICAL PROPERTIES
Maltese: Farmakoviġilanza
English: Split influenza virus*, inactivated containing antigen equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A).......................................3.8 micrograms**
Maltese: Virus tal-influwenza maqsum*, inattivat, li fih antiġen ekwivalenti għal: A/California/7/2009 (H1N1)-like strain (NYMC X-179A).......................................3.8 mikrogrammi**
English: per 0.5 ml dose
Maltese: f'kull doża ta' 0.5 ml
English: AF03 adjuvant composed of squalene, sorbitan oleate, polyoxyethylene cetostearyl ether and mannitol
Maltese: AF03 adjuvant magħmul minn squalene, sorbitan oleate, polyoxyethylene cetostearyl ether u mannitol
English: 21 days after 2nd dose
Maltese: 21 jum wara t-2 doża
English: In a clinical trial, the immunogenicity 21 days after each injection of HUMENZA given 21 days apart has been assessed in 50 children from 3 to 8 years of age and 49 adolescents from 9 to 17 years of age.
Maltese: Fi prova klinika l-immunoġeniċità 21 jum wara kull injezzjoni ta' HUMENZA li jingħata wara 21 ijiem ġiet evalwata f'50 tifel u tifla ta' bejn 3 snin sa 8 snin, u 49 adolexxenti ta' bejn 9 snin sa 17-il sena.
English: Independently of the cohort safety study (9,000 subjects), the MAH commits to implement a post-licensure prospective clinical safety study (N=3,000 subjects from 6 months of age).
Maltese: Indipendenti minn l-istudju tas-sigurta (9,000 persuni) iddetentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq jimpenja ruħu li jimplimenta studju tas-sigurta prospettiv wara li jingħata il-licenzja (N=3,000 persuni minn eta' ta' 6 xhur).
English: Musculoskeletal and connective tissue disorders - Very common: myalgia
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi - Komuni ħafna: mijalġja
English: In an open-label clinical trial, two doses (0.5 ml) of HUMENZA have been administered at a 3-week interval in 153 subjects (99 adults and 54 elderly).
Maltese: Fi prova klinika bit-tikketta tidher, żewġ dożi (0.5 ml) ta' HUMENZA ngħataw f'intervall ta' 3 ġimgħat lil 153 suġġett (99 persuna adulta u 54 anzjan).
English: Blood and lymphatic system disorders: Transient thrombocytopenia, transient lymphadenopathy
Maltese: Disturbi tad-demm u tas-sistema limfatika: Tromboċitopenija temporanja, limfadenopatija temporanja
English: Overall, local and systemic reactions were less frequently observed in children from 6 to 35 months of age than in children from 3 to 8 years, except fever which was more frequently observed in children from 6 to 23 months.
Maltese: Globalment, reazzjonijiet lokali u sistemiċi kienu osservati b'mod inqas frekwenti fi tfal minn 6 xhur sa 35 xahar milli fi tfal bejn 3 sa 8 snin, ħlief id-deni li kien osservat b'mod iktar frekwenti fi tfal bejn is-6 xhur sa 23 xahar.
English: Seronegative subjects prior to vaccination N= 14
Maltese: Persuni seronegattivi qabel ittilqima N= 14
English: Very common: irritability, crying abnormal, appetite lost, drowsiness, fever, vomiting.
Maltese: Komuni ħafna: irritabilità, biki anormali, telf ta' aptit, ngħas, deni, rimettar.
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Maltese: Rispons immuni protettiv jista' ma jinkisibx fil-pazjenti kollha li jkunu ngħataw it-tilqima (ara sezzjoni 5.1).
English: Seronegative subjects prior to vaccination N= 1
Maltese: Persuni seronegattivi qabel ittilqima N= 1
English: The adjuvant (AF03) is composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams), per 0.5 ml dose
Maltese: L-adjuvant (AF03) hu magħmul minn squalene (12.4 milligrammi), sorbitan oleate (1.9 milligrammi), polyoxyethylene cetostearyl ether (2.4 milligrammi) u mannitol (2.3 milligrammi), f'kull doża ta' 0.5 ml
English: One pack containing: - One pack of 10 vials (type I glass) of 1.5 ml suspension (antigen) with stopper (chlorobutyl).
Maltese: Pakkett wieħed ikun fih: - Pakkett wieħed ta' 10 kunjetti (ħġieġ ta' tip I) ta' 1.5 ml ta' suspensjoni (antiġen) b'tapp
English: Fever (≥ 38°C) Headache Malaise
Maltese: Deni (≥ 38°C) Uġigħ ta' ras Telqa
English: Children (6 to 11 months of age)
Maltese: Tfal (minn 6 sa 11-il xahar)
English: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)...........................................3.8 micrograms**
Maltese: A/California/7/2009 (H1N1)-like strain (NYMC
English: Sanofi Pasteur Sp. z o.o.
Maltese: Sanofi Pasteur MSD Spa
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Maltese: Waqt sitwazzjoni pandemika, il-frekwenza ta' sottomissjoni ta' rapporti perjodiċi fuq aġġornament ta' sigurta' kif speċifikat f'Artiklu 24 tar-Regolament (EC) Nru 726/2004 ma jkunx biżżejjed għassorveljanza ta' sigurta' ta' vaċċin pandemiku li għalih ikun mistenni livelli għolja ta' espożizzjoni f'perjodu qasir ta' żmien.
English: NAME OF THE MEDICINAL PRODUCT Antigen for HUMENZA suspension for injection Pandemic influenza vaccine (H1N1)
Maltese: Antiġen għal HUMENZA suspensjoni għall-injezzjoni Tilqima kontra l-influwenza pandemika (H1N1)