FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Pandemrix
Maltese: X'fih Pandemrix
English: Conduct non-clinical (including mechanistic) studies in order to elucidate the role of the vaccine and its adjuvant on the association between Pandemrix and narcolepsy: - Identify T cell signature from narcoleptic patients by deep sequencing of total CD4 T cells obtained from narcolepsy patients and DQ0602-matched non-vaccinated healthy subjects and, if identified, verify if signature is found in CD4 T cells from healthy subjects after vaccination with Pandemrix or non-adjuvanted H1N1v vaccine.
Maltese: - Identifika l-firma taċ-ċellola T minn pazjenti b'narkolessija b'sekwenzjar profond taċ-ċelloli CD4T totali minn pazjenti b'narkolessija u individwi b'saħħithom mhux imlaqqmin mqabblin għad-DQ0602 u, jekk tiġi identifikata, jiġi vverifikat jekk il-firma tinstabx fiċ-ċelloli CD4 T minn individwi b'saħħithom wara tilqima b'Pandemrix jew b'vaċċin H1N1v mhux aġġuvanat.
English: Month 12 N=14
Maltese: Xahar 12 N=14
English: A/California/07/2009 (H1N1) derived strain used NYMC X-179A I.M.
Maltese: *Antiġen: razza derivata minn A/California/07/2009 (H1N1) bl-użu ta' NYMCX-179A
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 Half dose
Maltese: Rispons immuni għal A/Netherlands/602/9 (H1N1)v-like1 Nofs doża
English: Suspension and emulsion for emulsion for injection.
Maltese: Pandemrix suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni.
English: Fever (>39°C) axillary
Maltese: Deni >38°C Deni >39°C
English: Month 6 N=13
Maltese: Xahar 6 N=13
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Maltese: nevrite u s-sindrome ta' Guillain Barré
English: 2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Maltese: Stimulant emulsjoni għall-injezzjoni 25 kunjett: emulsjoni 2.5ml
English: No data are available in children aged less than 6 months.
Maltese: Tfal b'età inqas minn 6 xhur Dejta mhux disponibbli.
English: Total enrolled subjects N=25
Maltese: Individ wi totali irreġistr ati N=25
English: 4according to protocol
Maltese: 4skont il-protokoll
English: Neuralgia
Maltese: Nevralġija
English: Total enrolled subjects2
Maltese: Total ta' Individwi irreġistrati2
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Maltese: 6 , għal thiomersal u għal residwi (proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate).
English: Total subjects4 N=30 [95% CI]
Maltese: Individwi totali4 N=30 [95% CI]
English: Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għal influwenza (H1N1)v (virjon maqsum, mhux attivat, stimulat)
English: The vaccine contains 5 micrograms thiomersal
Maltese: Eċċipjent b'effett magħruf Il-vaċċin fih 5 mikrogrammi thiomersal
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pandemrix
Maltese: Suspensjoni għall-emulsjoni għall-injezzjoni għal Pandemrix
English: The side effects listed above have also been observed with similar frequencies in clinical studies in children 10 to 17 years of age, except for redness at the injection site which was very common and sweating which was common.
Maltese: L-effetti sekondarji elenkati fuq kienu osservati wkoll bi frekwenzi simili fi studji kliniċi fi tfal b'età minn 10 snin sa 17-il sena, ħlief għal ħmura fis-sit tal-injezzjoni li kienet komuni ħafna u għaraq li kien komuni.
English: Total subjects4 N=28 [95% CI]
Maltese: Individwi totali4 N=28 [95% CI]
English: Total subjects4 N=51 [95% CI]
Maltese: Individwi totali4 N=51 [95% CI]
English: Serum neutrali-sing antibody
Maltese: Antikorp li jinnewtralizza fis-serum
English: Total subjects5 [95% CI]
Maltese: Individwi totali5 [95% CI]
English: Month 12 N=13
Maltese: Xahar 12 N=13
English: Total enrolled subjects N=15
Maltese: Individ wi totali irreġistr ati N=15
English: Total subjects4 N=55 [95% CI]
Maltese: Individwi totali4 N=55 [95% CI]
English: In the children who had received two adult (0.5 ml) doses, the seroprotection rates twelve months after the first dose were 100% for children aged 3-5 years and 98.0% for those aged 6-9 years.
Maltese: Fi tfal li rċevew żewġ dożi tal-adulti (0.5 ml), ir-rati ta' seroprotezzjoni tnax-il xahar wara l-ewwel doża kienu ta' 100% għal tfal b'età minn 3-5 snin u ta' 98.0% għal dawk b'età minn 6-9 snin.
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
Maltese: 3fattur ta' serokonverżjoni: proporzjon tal-medja tat-titre ġeometriku (GMT) wara t-tilqim u GMT
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION (ANTIGEN)
Maltese: U KONTENUT Suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni 50 kunjett: suspensjoni (antiġen)
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6), to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Maltese: • jekk xi darba kellek reazzjoni allerġika li ma kenitx f'daqqa u ta' periklu għal-ħajja għal xi sustanza f'dan il-vaċċin (elenkati fis-sezzjoni 6), għal thiomersal, proteina tal-bajd u tattiġieġ, ovalbumin, formaldehyde, gentamycin sulphate (antibiotiku) jew sodium deoxycholate.
English: In children 3 to 9 years of age who received two 0.25 ml doses of Pandemrix (H1N1) the side effects reported were similar to those reported in adults, except for redness at the injection site and gastrointestinal symptoms which were very common and shivering and sweating which were common.
Maltese: Fi tfal b'età minn 3 snin sa 9 snin li rċevew żewġ dożi ta' 0.25 ml ta' Pandemrix (H1N1)v l-effetti sekondarji rrappurtati kienu simili għal dawk irrappurtati fl-adulti, ħlief għal ħmura fis-sit tal injezzjoni u sintomi gastro-intestinali li kienu komuni ħafna u tertir u għaraq li kienu komuni.
English: Seronegative subjects prior to vaccination N=16 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=16 [95% CI]
English: In particular rates of fever (axillary temperature ≥38°C) increased considerably after the second dose.
Maltese: (temperatura ta' taħt id-driegħ ≥38°C) żdiedu b'mod konsiderevoli wara t-tieni doża.
English: Post dose
Maltese: Nofs doża
English: Transient thrombocytopenia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Seronegative subjects prior to vaccination N=26 [95% CI]
Maltese: Individwi seronegattivi qabel it-tilqim N=26 [95% CI]
English: Children aged from 6 months to 9 years
Maltese: Tfal b'età minn 6 xhur sa 9 snin
English: Seronegative subjects prior to vaccination N=36 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=36 [95% CI]
English: Total subjects4 [95% CI]
Maltese: Individwi totali4 [95% CI]
English: Rate2
Maltese: ANNESS II
English: The side effects listed below have happened after Pandemrix (H1N1)v came on the market:
Maltese: L-effetti sekondarji elenkati taħt seħħew wara t-tqegħid fis-suq ta' Pandemrix (H1N1)v:
English: 21 days after 2nd dose
Maltese: 21 ġurnata wara ttieni doża
English: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** * propagated in eggs ** haemagglutinin
Maltese: X-179A 3.75 mikrogrammi** * imnissla fil-bajd ** emagglutinina
English: In clinical studies that evaluated the reactogenicity in children 10 to 17 years of age who received either two 0.5 ml doses (adult dose) or two 0.25 ml doses (half adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:
Maltese: Fi studji kliniċi li evalwaw ir-reattoġeniċità fi tfal b'età minn 10 snin sa 17-il sena li rċevew żewġ dożi ta' 0.5 ml (doża tal-adulti) jew żewġ dożi ta' 0.25 ml (nofs doża tal-adulti) (21 ġurnata bogħod minn xulxin) ta' Pandemrix (H1N1)v, il-frekwenza għal kull doża tar-reazzjonijiet avversi li ġejjin kienet kif muri fit-tabella:
English: Very common Arthralgia, myalgia
Maltese: Mhux komuni Parasteżija, sturdament
English: anti-HA antibody
Maltese: Antikorp antiHA
English: Seronegative subjects prior to vaccination N=48 [95% CI]
Maltese: Individwi seronegattivi qabel it-tilqim N=48 [95% CI]
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Maltese: 1 rata ta' seroprotezzjoni: proporzjon ta' individwi b'titre ta' inibizzjoni tal-emagglutinazzjoni (HI) ≥
English: Seronegative subjects prior to vaccination N=37 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=37 [95% CI]
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with other (H1N1)v vaccines.
Maltese: ma ssuġġeriet l-ebda interferenza sinifikanti fir-rispons immuni għal Pandemrix (H1N1)v.
English: 10-17 years
Maltese: 10-17-il sena
English: Seronegative subjects prior to vaccination N=29 [95% CI]
Maltese: Individwi seronegattivi qabel it-tilqim N=29 [95% CI]
English: Seronegative subjects prior to vaccinatio n N=15 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=15 [95% CI]
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir- rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi ta 'aġġornament għal dan il-prodott mediċinali huma mniżżlin fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornamenti sussegwenti jigu ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Redness Swelling Fever (>38°C) axillary
Maltese: Deni (≥38°C) taħt iddriegħ
English: Seronegative subjects prior to vaccination N=32 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=32 [95% CI]
English: Seronegative subjects prior to vaccination N=42 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=42 [95% CI]
English: In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose particularly in rates of axillary fever (>38°C).
Maltese: Fi studju kliniku li evalwa ir-reattoġeniċità fi tfal b'età minn 6 xhur sa 35 xahar li rċevew żewġ dożi ta' 0.25 ml (nofs doża tal-adulti) jew żewġ dożi ta' 0.5 ml (doża tal-adulti) (21 ġurnata bogħod minn xulxin) ta' Pandemrix (H1N1)v kien hemm żjieda fir-reazzjonijiet fis-sit tal-injezzjoni u fis-sintomi ġenerali wara t-tieni doża meta mqabbel mal-ewwel doża b'mod partikulari fir-rati ta' deni ta' taħt iddriegħ (≥38°C).
English: Seronegative subjects prior to vaccination N=19 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=19 [95% CI]
English: Immune response to A/California/7/2009 (H1N1)v-like D-Pan H1N1-007
Maltese: Razza derivata minn A/California/07/2009 (H1N1) bl-użu ta' NYMC
English: Total enrolled subjects N=67 [95% CI]
Maltese: N=67 [95% CI]
English: However, in the case this needle size would not be available, a 21-G needle might be used.
Maltese: Madankollu, f'każ li dan id-daqs ta' labra ma jkunx disponibbli, tista' tintuża labra ta' 21-G.
English: Data obtained on co-administration of Pandemrix (H1N1)v with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. The immune response to Fluarix was satisfactory.
Maltese: Dejta miksuba wara l-għoti ta' Pandemrix (H1N1)v flimkien ma' vaċċin mhux stimulat ta' linfluwenza staġjonali (Fluarix, vaċċin b'virjon maqsum) f'adulti b'saħħithom b'età 'l fuq minn 60 sena ma ssuġġerit l-ebda interferenza sinnifikanti fir-rispons immuni għal Pandemrix (H1N1)v.
English: • Generally feeling unwell
Maltese: Total ta' Individwi irreġistrati
English: Split influenza virus inactivated, containing antigen equivalent to: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms* AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
Maltese: Profilassi ta' influwenza kkawżata mill-virus A (H1N1)v 2009, Pandemrix għandu jintuża biss jekk ittilqim trivalenti/kwadrivalenti tal-influwenza tal-istaġun annwali rrakkomandata ma jkunx disponibbli u jekk tilqim kontra (H1N1)v huwa meqjus neċessarju (ara sezzjonijiet 4.4 u 4.8).
English: Half adult dose (D-Pan-H1N1-023)
Maltese: (D-Pan-H1N1-023)
English: Month 6 after 2 doses of 0.5 ml
Maltese: 6 xhur wara żewġ dożi ta' 0.5 ml
English: NAME OF THE MEDICINAL PRODUCT Pandemrix suspension and emulsion for emulsion for injection.
Maltese: Informazzjoni għall-utent Pandemrix suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni
English: Seronegative subjects prior to vaccination N=1 [95% CI]
Maltese: Individwi seronegattivi qabel it-tilqim N=1 [95% CI]
English: Seronegative subjects prior to vaccination N=7 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=7 [95% CI]
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code: J07BB02.
Maltese: Vaċċini ta' l-influwenza, Kodiċi ATC:
English: Your doctor will normally recommend a different vaccine (annual trivalent/quadrivalent influenza vaccine) instead of Pandemrix, but if the trivalent/quadrivalent vaccines are not available Pandemrix may still be an option if you need protection against A(H1N1)v influenza (see Take special care with Pandemrix).
Maltese: It-tabib tiegħek normalment jirrakkomanda tilqima differenti (tilqima tal-influwenza trivalenti/kwadrivalenti annwali) minflok Pandemrix, iżda jekk it-tilqim trivalenti/kwadrivalenti ma jkunx disponibbli Pandemrix xorta jista' jkun għażla jekk teħtieġ protezzjoni kontra l-influwenza
English: One pack of Pandemrix consists of:
Maltese: Pakkett wieħed ta' Pandemrix fih:
English: 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre;
Maltese: 2rata ta' serokonverżjoni: proporzjon ta' individwi li kienu seronegattivi qabel it-tilqim u għandhom titre protettiv ta' ≥ 1:40 wara t-tilqim, jew li kienu seropożittivi qabel it-tilqim u għandhom żjieda ta' 4
English: Additional side effects in children and adolescents
Maltese: Effetti sekondarji oħra fi tfal u adoloxxenti
English: Fatigue
Maltese: Tilqima2
English: It is recommended to equip the syringe with a needle gauge not larger than 23-G.
Maltese: Huwa rrakkomandat li s-siringa tiġi mgħammra b'labra ta' ħxuna ta' mhux aktar minn 23-G.
English: 2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre
Maltese: 2persentaġġ ta' persuni li ġew imlaqqma li, jekk fil-bidu kienu seronegattivi jilħqu titre ta' antikorpi ta' ≥32 1/DIL wara t-tilqim jew, jekk fil-bidu kienu seropożittivi jilħqu titre tal-antikorpi ta' ≥ 4 darbiet ittitre tal-antikorpi ta' qabel it-tilqim
English: Please consult the Product Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
Maltese: Jekk jogħġbok ikkonsulta l-Informazzjoni tal-Prodott tal-vaċċin tal-influwenza Pandemika (H5N1) (virjon maqsum, mhux attivat, stimulat).
English: Vaccine Response Rate2 1antigenically similar to A/California/7/2009 (H1N1)v-like 2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre
Maltese: 1jixbah b'mod antiġeniku lil razza li tixbaħ lil A/California/7/2009 (H1N1)v 2perċentwal ta' dawk li ħadu t-tilqima li, jekk fil-bidu kienu seronegattivi jilħqu titre ta' antikorpi ta' ≥32 1/DIL wara t-tilqima jew, jekk kienu seropożittivi jilħqu titre ta' antikorpi ta' ≥ 4 darbiet aktar mit-titre ta' antikorpi li kien hemm qabel it-tilqima Antikorp li jinnewtralizza fis-serum
English: Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
Maltese: Kull doża ta' vaċċin ta' 0.5 ml (doża sħiħa) jew 0.25 ml (nofs doża) tinġibed ġo siringa għall injezzjoni ta' 1 ml u tingħata ġol-muskolu.
English: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
Maltese: Is-sustanzi l-oħra huma: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl),
English: The vaccine should be administered in accordance with the recommended posology (see section 3 “How Pandemrix is given”).
Maltese: Il-vaċċin għandu jingħata skond il-posoloġija rakkomandata (ara sezzjoni 3 "Kif jingħata Pandemrix”).
English: Uncommon Lymphadenopathy
Maltese: Il-Belġju
English: Seronegative subjects prior to vaccination N=3 [95% CI]
Maltese: Individwi seronegattivi qabel it-tilqim N=3 [95% CI]
English: In a clinical study where a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) was administered 3 weeks after the second dose of Pandemrix (two doses were given 21 days apart), a lower immune response to Fluarix was observed as compared to subjects who had not previously received Pandemrix.
Maltese: Fi studju kliniku fejn ingħatat tilqima tal-influwenza tal-istaġun mhux awżiljata (Fluarix, bħal hawn fuq) 3 ġimgħat wara t-tieni doża ta' Pandemrix (żewġ dożi ingħataw 21 jum bogħod minn xulxin),
English: Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Maltese: Il-gruppi ta' kontroll kienu jinkludu inmsa mlaqqma bl-istimulant biss, bil-vaċċin mhux stimulat (15-il mikrogramma HA) jew b'soluzzjoni ta' salina ibbafferjata bil-fosfat.
English: Antigen suspension for Pandemrix Influenza vaccine
Maltese: U KONTENUT Antiġen suspensjoni għall-injezzjoni
English: The volume of the Pandemrix vial after mixing is at least 5 ml.
Maltese: Il-volum tal-kunjett ta' Pandemrix (5 ml) wara li jitħallat huwa ta' l-inqas 5ml.
English: - Phenotypic characterization of hypocretin and influenza-specific T cells after stimulation with hypocretin or influenza peptides.
Maltese: speċifiċi għall-influwenza wara stimulazzjoni b'ipokretin jew b'peptidi tal-influwenza.
English: Twelve months after the first dose, the seroprotection rates in the children who had received two half (0.25 ml) doses were 90.2% and 100% in those who had received two full (0.5 ml) adult doses.
Maltese: Tnax-il xahar wara l-ewwel doża, ir-rati ta' seroprotezzjoni fi tfal li rċevew żewġ nofs dożi (0.25 ml) kienu ta' 90.2% u ta' 100% f'dawk li rċevew żewġ dożi sħaħ (0.5 ml) tal-adulti.
English: In children/adolescents (aged up to 20 years), these studies have indicated an additional 1.4 to 8 cases in 100,000 vaccinated subjects.
Maltese: Fi tfal/adolexxenti (eta' sa 20 sena), dawn l-istudji indikaw 1.4 sa 8 każijiet addizzjonali f'100,000 individwu mlaqqam.
English: Seroconversio n rate2
Maltese: serokonverżjon i2
English: Seroconversio n factor3
Maltese: Fattur ta' serokonver żjoni 3
English: A dose (0.5 ml) of the vaccine will be given.
Maltese: Tingħata doża waħda (0.5ml) tal-vaċċin.
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C.
Maltese: Il-vaċċin imħallat jista' jinħażen fi friġġ (2°C - 8°C) jew f'temperatura tal-kamra ta' mhux aktar minn 25°C.
English: Tell the doctor requesting these tests that you have recently been given Pandemrix.
Maltese: L-ebda każ ta' doża eċċessiva ma ġie rrappurtat.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Maltese: Waqt l-użu, l-istabbilità kimika u fiżika ġiet ipprovata għal perjodu ta' 24 siegħa f'temperatura ta' 25°C.
English: Children from the age of 10 years onwards
Maltese: Tfal b'età minn 10 snin sa 17-il sena
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: potassium (39 mg) f'kull doża, i.e. essenzjalment huwa mingħajr sodium u potassium.
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)vlike strains.
Maltese: Vaċċin għal influwenza Razza derivata minn A/California/07/2009 (H1N1) bl-użu ta' NYMC
English: The side effects listed below have occurred with Pandemrix in clinical studies in adults, including the elderly.
Maltese: L-effetti mhux mixtieqa imniżżla hawn taħt seħħew b'Pandemrix fi studji kliniċi f'adulti, inkuż l anzjani.
English: Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Arthralgia Myalgia Fatigue
Maltese: • jekk għandek infezzjoni severa b'deni għoli ('l fuq minn 38°C).
English: Immune response to A/California/7/2009 (H1N1)v-like
Maltese: Rispons immuni għar-razza li tixbaħ lil A/California/7/2009 (H1N1)v
English: Month 12 after 2 doses of 0.5 ml
Maltese: 6 xhur wara doża waħda ta' 0.5 ml
English: Injection site reactions (such as inflammation, mass, ecchymosis)
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (bħal infjammazzjoni, għoqda, ekimożi)
English: It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between
Maltese: Huwa magħruf li r-riskju ta' tromboemboliżmu arterjali (ATE) (infart mijokardijaku, inċident ċerebrovaskulari) jiżdied ukoll bl-użu ta' CHCs, iżda ma kien hemm l-ebda evidenza ta' differenzi bejn is-CHCs fir-riskju relattiv tagħhom ta' ATE.
English: These are combined with varying doses of ethinylestradiol
Maltese: Dawn jiġu kkombinati ma' dożi li jvarjaw ta' ethinylestradiol (EE) jew ma' estradiol (E2).
English: In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrel
Maltese: Barra minn hekk il-PRAC impona studju dwar is-sigurtà wara l-awtorizzazzjoni sabiex jiġi kkaratterizzat aħjar ir-riskju relattiv ta' avvenimenti tromboembolitiċi minħabba chlormadinone meta mqabbla malprodotti mediċinali li fihom levonorgestrel.
English: The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk
Maltese: Il-PRAC ikkonferma r-riskju magħruf ta' tromboemboliżmu ta' prodotti mediċinali li fihom kontraċettivi ormonali kkombinati, u rrakkomanda tikkettar ċar tas-sintomi ta' avvenimenti tromboemboliċi, kif ukoll il-fatturi ta' riskju għal avvenimenti tromboemboliċi.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation
Maltese: Il-PRAC, bħala konsegwenza, ikkonkluda li l-bilanċ tal-benefiċċju-riskju tal-prodotti mediċinali Evra, Ioa u Zoely fl-indikazzjoni ta' kontraċezzjoni jibqa' favorevoli, soġġett għall-kundizzjonijiet, restrizzjonijiet, twissijiet, tibdil ieħor lill-informazzjoni dwar il-prodott u miżuri addizzjonali għall-minimizzazzjoni tarriskju miftiehma.