FrancophonIA/ELRC3.0 huggingface dataset:
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Maltese: Mard newroloġiku, bħal enċefalomajelite, nevrite u s-sindrome ta' Guillain Barré.
English: However, in a pandemic situation, you may still be given the vaccine.
Maltese: Madankollu, f'sitwazzjoni pandemika, inti xorta tista' tingħata t-tilqima.
English: - All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Maltese: - L-avvenimenti kollha mhux ikkonfermati medikament huma dawk kollha li ddaħħlu fid-database mid-data-lock point.
English: What Foclivia looks like and contents of the pack
Maltese: Id-dehra ta' Foclivia u d-daqs tal-pakkett
English: Packs of 1 and 10 with or without needle.
Maltese: Pakketti ta' 1 u 10 bi jew mingħajr labra.
English: Seroprotection rate (95%CI)° Seroconversion rate (95%CI)°
Maltese: Rata ta' seroprotezzjoni (95%CI
English: Ready-to-use syringe, containing a single dose of 0.5 ml for injection.
Maltese: Siringa lesta biex tintuża, li fiha doża waħda ta' 0.5 mL għall-injezzjoni.
English: narrow SMQ “Non-infectious encephalitis”
Maltese: SMQ dejqa “Enċefalite mhux infettuża”
English: - All tables will be based on generic and not product-specific data1.
Maltese: - It-tabelli kollha se jkunu bbażati fuq dejta ġenerika u mhux fuq dejta li tkun speċifika għall-prodott1.
English: Foclivia should be used in accordance with Official Guidance.
Maltese: Foclivia kien awtorizzat taħt “Ċirkustanzi ta' Eċċezzjoni”.
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, water for injections.
Maltese: Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Ilma għall-injezzjonijiet.
English: In a phase II clinical trial (Study V87P6) safety of a pandemic preparedness adjuvanted H5N1 vaccine was evaluated in children and adolescent (see section 5.1 for more information).
Maltese: Tfal u adolexxenti li jkollhom minn 6 xhur sa 17-il sena: Fi prova klinika ta' fażi II (Studju V87P6), is-sigurtà ta' tilqima ta' tħejjija adjuvanted kontra H5N1
English: These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Maltese: ‘ġodda' u jistimulaw sitwazzjoni fejn il-popolazzjoni fil-mira għat-tilqim tkun immunoloġikament naïve.
English: Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Maltese: It-tilqima għandha ssir permezz ta' injezzjoni ġol-muskoli fil-muskolu tad-deltojde jew fil-koxxa anterolaterali (skont il-massa tal-muskoli).
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorp anti-HA għal H5N1 A/Vjetnam/1194/2004 imkejla permezz ta' assaġġi
English: Children (3 to 8 years of age)
Maltese: Tfal (minn 3 sa 8 snin)
English: It is essentially sodium- and potassium-free.
Maltese: Hu essenzjalment ħieles mis-sodium u mill-potassium.
English: Some cases were observed in subjects with a history of epilepsy.
Maltese: individwi bi storja medika ta' epilessija.
English: Common (may affect up to 1 in 10 people).
Maltese: Komuni: (jistgħu jaffettwaw sa 1 minn kull 10 persuni).
English: - Anaphylaxis:
Maltese: - Vaskulite:
English: Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Maltese: 3. Avvenimenti Avversi ta' Interess Speċjali stratifikati skont it-tip ta' rapport (ikkonfermati medikament jew mhux ikkonfermati medikament).
English: Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43
Maltese: Rata ta' seroprotezzjoni (95% CI) Jum 43
English: * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
Maltese: (95%CI)** * imkejla permezz ta' assaġġ SRH ≥ 25 mm2
English: Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Maltese: L-influwenza pandemika hi tip ta' influwenza li sseħħ f'intervalli li jvarjaw minn inqas minn 10 snin sa ħafna għexieren ta' snin.
English: Uncommon: (may affect up to 1 in 100 people).
Maltese: Mhux komuni: (jistgħu jaffettwaw sa 1 minn kull 100 persuna).
English: This vaccine complies with the WHO recommendations and EU decision for the pandemic.
Maltese: Din it-tilqima hi konformi mar-rakkomandazzjonijiet tal-WHO u mad-deċiżjoni tal-UE għall-pandemija.
English: Any adverse reaction Local
Maltese: Kwalunkwe Lokali
English: Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate,
Maltese: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate,
English: Local
Maltese: Tqala
English: The European medicines Agency has deferred the obligation to submit the results of studies with Foclivia in one or more subsets of the paediatric populations in active immunisation against H5N1 subtype of Influenza A virus.
Maltese: L-Aġenzija Ewropea tal-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Foclivia f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fl-immunizzazzjoni attiva kontra s-sottotip H5N1 tal-virus tal-Influwenza A.
English: All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Maltese: Ir-reazzjonijiet avversi spontanji kollha skont il-grupp ta' età, għal kull SOC, HLT u PT, stratifikati skont it-tip ta' rapport (ikkonfermati medikament jew mhux ikkonfermati medikament), għall-perjodu kopert mir-rapport u kumulattivament.
English: Instructions for administration of the vaccine:
Maltese: Kategorija farmakoterapewtika:
English: Numbness or tingling sensations, involuntary muscle contractions or thrombocytopenia (reduction in the number of certain types of particles in the blood called plateles; a low number of these can result in excessive bruising or bleeding).
Maltese: Tmewwit jew sensazzjonijiet ta' tnemnim, kontrazzjonijiet involontarji tal-muskoli jew tromboċitopenija (tnaqqis fin-numru ta' ċerti tipi ta' partikuli fid-demm li jissejħu plejtlits; numru baxx minn dawn jista' jirriżulta fi tbenġil eċċessiv jew fi ħruġ ta' demm).
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Maltese: Sinkope (ħass ħażin) jista' jseħħ wara, jew anki qabel, kwalunkwe tilqima bħala rispons psikoġeniku għall-injezzjoni bil-labra.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan
Maltese: Matul il-pandemija, l-applikant ser iwettaq studju tat-tip cohort prospettiv, kif identifikat fil-pjan tal-Farmakoviġilanza.
English: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Maltese: Disturbi gastrointestinali, bħal dardir, rimettar, uġigħ addominali u dijarea.
English: Some cross-protection was observed against related H5N1 virus variants in clinical trials (see section 5.1).
Maltese: Fil-provi kliniċi ġiet osservata xi protezzjoni inkroċjata kontra varjanti tal-virus H5N1 relatati
English: Foclivia suspension for injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Maltese: Tilqima kontra l-Influwenza Pandemika (antiġen tal-wiċċ, inattivat, adjuvanted)
English: Any
Maltese: E.
English: Adverse event(s) from post-marketing surveillance with the pandemic vaccine: not applicable.
Maltese: Avvenimenti avversi minn sorveljanza ta' wara t-tqegħid fis-suq bit-tilqima pandemika: mhux applikabbli.
English: Package leaflet: Information for the user Foclivia suspension for injection
Maltese: Foclivia suspensjoni għall-injezzjoni
English: Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Maltese: rapport (ikkonfermati medikament jew mhux ikkonfermati medikament) u skont is-serjetà, għall-perjodu kopert mir-rapport u kumulattivament.
English: A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle).
Maltese: Doża (0.5 ml) tat-tilqima se tiġi injettata fil-parti ta' fuq tad-driegħ (muskolu tad-deltojde).
English: syndrome: - Demyelination:
Maltese: - Demajlinazzjoni:
English: AESIs will be defined as follows:
Maltese: AESIs sejrin jiġu definiti kif ġej:
English: Safety data are available, however, in pregnant women exposed to Focetria (an H1N1 pandemic vaccine similar to Foclivia) which contains the same amount of MF59C.1 as Foclivia.
Maltese: H1N1 pandemiku simili għal Foclivia) li fih l-istess ammont ta' MF59C.1 bħal Foclivia.
English: 2719 EE Zoetermeer The Netherlands
Maltese: 2719 EE Zoetermeer L-Olanda
English: WC2B 4AE, United Kingdom
Maltese: WC2B 4AE
English: Almirall S.A., Ronda General Mitre, 151 08022 Barcelona, Spain
Maltese: Almirall, S.A. Ronda General Mitre, 151 08022 Barcelona Spanja
English: Netherlands AstraZeneca BV Louis Pasteurlaan 5
Maltese: L-Olanda AstraZeneca BV Louis Pasteurlaan 5
English: DK-2620 Albertslund, Denmark
Maltese: DK-2620 Albertslund, Id-Danimarka
English: 15 Stanhope Gate London W1K 1LN United Kingdom
Maltese: London W1K 1LN
English: Rua Humberto Madeira, 7, Queluz de Baixo 2730-097 Barcarena, Portugal
Maltese: Rua Humberto Madeira, 7, Queluz de Baixo 2730-097 Barcarena, Il-Portugall
English: Takeda UK Limited, Takeda House, Mercury Park, Wycombe Lane, Wooburn Green, High Wycombe,
Maltese: L-Irlanda Takeda UK Limited Takeda House, Mercury Park, Wycombe Lane, Wooburn Green, High Wycombe,
English: AstraZeneca A/S Roskildevej 22
Maltese: Id-Danimarka AstraZeneca A/S Roskildevej 22
English: AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norway
Maltese: In-Norveġja AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo , In-Norveġja
English: AstraZeneca GmbH 22876 Wedel, Germany
Maltese: Il-Ġermanja AstraZeneca GmbH 22876 Wedel, Il-Ġermanja
English: AstraZeneca SA Theotokopoulou 4 & Astronafton 151 25 Maroussi Greece
Maltese: AstraZeneca SA Theotokopoulou 4 & Astrnafton 151 25 Maroussi
English: Atacand Plus
Maltese: Atacand Plus Mite
English: B-1180 Brussels
Maltese: B-1180 Brussel Il-Belġju
English: Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London,
Maltese: Takeda Global Research and Development Centre (Europe) Ltd
English: AstraZeneca UK Limited
Maltese: Is-Slovenja AstraZeneca UK Limited 15
English: AstraZeneca SpA Palazzo Volta-via F Sforza - 20080 Basiglio (MI)Italy
Maltese: AstraZeneca SpA Palazzo Volta, via F.Sforza20080
English: AstraZeneca Kft. 1113 Budapest, Bocskai út 134-146 Hungary
Maltese: Bocskai út 134-146
English: LusomedicamentaSociedade Técnica Farmacêutica, S.A. Estrada Consiglieri Pedroso, 69 BQueluz de Baixo 2730-055 Barcarena, Portugal
Maltese: Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo 2730-055 Barcarena Il-Portugall
English: Ophemstraat 110
Maltese: NV AstraZeneca SA Egide Van Ophemstraat 110
English: Belgium NV AstraZeneca SA Egide Van
Maltese: Il-Belġju NV AstraZeneca SA Egide Van Ophemstraat 110
English: Czech Republic AstraZeneca UK Ltd., Macclesfield, Cheshire, United Kingdom
Maltese: AstraZeneca UK Ltd., Macclesfield, Cheshire, Ir-Renju Unit
English: Takeda Italia Farmaceutici S.p.A., Via Elio Vittorini, 129 00144 Roma Italy
Maltese: Via Elio Vittorini, 129
English: AstraZeneca Österreich GmbH., Schwarzenbergplatz 7, A-1037 Wien, Austria
Maltese: L-Awstrija AstraZeneca Österreich GmbH., Schwarzenbergplatz 7,
English: Laboratoires Takeda, 11-15, quai de Dion Bouton,
Maltese: Laboratoires Takeda 11-15, quai de Dion Bouton 92816 Puteaux Cedex Franza
English: Viktoriaallee 3-5, 52066 Aachen, Germany
Maltese: 52066 Aachen
English: Capability Green, Luton, LU1 3LU, United Kingdom
Maltese: L-Irlanda AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, Ir- Renju Unit
English: AstraZeneca AB, Strängnäsvägen 44, S-151 85 Södertälje, Sweden
Maltese: L-Estonja AstraZeneca AB, Strängnäsvägen 44, S-151 85 Södertälje, L-Isvezja
English: Takeda Pharma GmbH,
Maltese: L-Awstrija Takeda Pharma Ges.m.b.H.
English: Buckinghamshire HP10 OHH
Maltese: HP10 OH
English: C/ Serrano Galvache
Maltese: Il-Greċja
English: Ireland
Maltese: Roma
English: Atacand Zid 32 mg / 12.5 mg
Maltese: Atacand Zid 32 mg/ 12.5 mg 32 mg / 12.5 mg
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Maltese: TALPRODOTT MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID
English: Atacand Zid 32 mg / 25 mg
Maltese: Atacand Zid 32 mg / 25 mg 32 mg / 25 mg Pillola
English: AstraZeneca AB, S151 85 Södertälje, Sweden
Maltese: AstraZeneca AB, S-151 85 Södertälje, L-Isvezja
English: Atacand Zid 16mg / 12.5 mg
Maltese: Atacand Zid 16 mg / 12.5 mg 16 mg / 12.5 mg
English: Italy
Maltese: London
English: Atacand Zid 8 mg / 12.5 mg
Maltese: Atacand Zid 8 mg / 12.5 mg 8 mg / 12.5 mg Pillola
English: AstraZeneca AB 151 85 Södertälje, Sweden
Maltese: L-Isvezja AstraZeneca AB 151 85 Södertälje, L-Isvezja
English: Blopress Comp 16 mg / 12.5 mg
Maltese: Blopresid 16/12.5 mg compresse 16 mg / 12.5 mg
English: CoKenzen
Maltese: Ċipru
English: Blopress Comp 32 mg / 12.5 mg
Maltese: Blopress Plus 32 mg/12.5 mg 32 mg / 12.5 mg
English: Atacand Plus 16 + 12.5 mg
Maltese: Atacand Plus 16 + 12.5 mg 16 mg / 12.5 mg
English: Blopress Comp 8 mg / 12.5 mg
Maltese: mg compresse 8 mg / 12.5 mg Pillola
English: Blopress Plus 32mg/25 mg tablets
Maltese: Blopress Plus 32 mg/25 mg 32 mg / 25 mg Pillola
English: Ratacand Plus 32 mg / 12.5 mg
Maltese: Atacand Plus 32 mg/12.5 mg 32 mg / 12.5 mg
English: Hytacand 16 mg 16 mg / 12.5 mg
Maltese: Blopress Plus 16 mg/12.5 mg 16 mg / 12.5 mg
English: Slovak Republic AstraZeneca AB, S151 85 Södertälje, Sweden
Maltese: Is-Slovakkja AstraZeneca AB, S-151 85
English: Ratacand Plus 16 mg / 12.5 mg
Maltese: Atacand Plus 16 mg/12.5 mg 16 mg / 12.5 mg
English: The full EPAR for Hexyon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Hexyon
Maltese: Informazzjoni oħra dwar Hexyon
English: Why is Hexyon approved?
Maltese: Għalfejn ġie approvat Hexyon?
English: Hexyon is a vaccine.
Maltese: Hexyon huwa vaċċin.
English: This is a summary of the European public assessment report (EPAR) for Hexyon.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Hexyon.
English: A subsequent study involving 455 children looked at the longer-term persistence of protective antibodies up to 3 years after a booster dose with Hexyon, and another study in 1,336 children evaluated the response to different lots of the vaccine and what happened when it was given with vaccines for infections caused by the bacterium Streptococcus pneumoniae (Prevenar) and rotavirus (Rotarix).
Maltese: Studju sussegwenti li involva 455 tifel u tifla studja l-persistenza fit-tul tal-antikorpi protettivi sa 3 snin wara li ngħatat doża booster b'Hexyon, u studju ieħor f'1,336 tifel u tifla evalwa r-rispons għal lottijiet differenti tal-vaċċin u x'ġara meta ngħata ma' vaċċini għal infezzjonijiet ikkaġunati mill-batterju Streptococcus pneumoniae (Prevenar) u rotavirus (Rotarix).
English: What are the risks associated with Hexyon?
Maltese: X'inhuma r-riskji assoċjati ma' Hexyon?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hexyon on 17 April 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Hexyon valida fl-Unjoni Ewropea kollha fis-17 ta' April 2013.
English: The CHMP noted that Hexyon has been shown to produce protective antibody levels against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and H. influenzae type b infections in children between six weeks and two years of age regardless of ethnicity.
Maltese: Is-CHMP innota li Hexyon intwera li jipproduċi livelli ta' antikorpi protettivi kontra l-infezzjonijiet taddifterite, it-tetnu, il-pertussi, l-epatite B, il-poljomelite u H. influenzae tip b fi tfal ta' bejn sitt ġimgħat u sentejn tkun xi tkun l-etniċità.
English: Hexyon is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type b bacteria, the hepatitis B virus, and inactivated polioviruses.
Maltese: Hexyon huwa vaċċin li fih s-sustanzi attivi li ġejjin minn difterite, tetnu, pertussi u batterji talHaemophilus influenzae tip b, il-virus tal-epatite B, u polivirusijiet inattivati.
English: The effects were compared with a combination of separate vaccines designed to protect against the diseases included in Hexyon.
Maltese: L-effetti tqabblu ma' kombinazzjoni ta' vaċċini separati mfassla sabiex jipproteġu kontra l-mard inkluż f'Hexyon.
English: In the study, children who either received Hexyon produced a similar antibody response to those who received a comparator vaccine (Infanrix hexa), when given as a two-dose schedule followed by a booster 6 months later.
Maltese: Flistudju, it-tfal li ħadu Hexyon ipproduċew rispons tal-antikorpi li kien simili għal dak li kellhom it-tfal li ħadu vaċċin komparatur (Infanrix hexa), meta ngħataw skeda f'żewġ dożi segwita minn booster 6 xhur wara.
English: Hexyon has been studied in several countries worldwide in 12 main studies involving over 3,400 children between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local vaccination schedules.
Maltese: Hexyon ġie studjat f'bosta pajjiżi madwar id-dinja fi 12-il studju ewlieni li involvew aktar minn 3,400 tifel u tifla ta' bejn sitt ġimgħat u sentejn li ngħataw tliet dożi tal-vaċċin matul l-ewwel sitt xhur ta' ħajjithom skont skedi lokali differenti ta' tilqim.
English: Regarding safety, the CHMP considered that Hexyon's overall safety profile is similar to other vaccines, although vaccination with Hexyon is more likely than similar vaccines to cause reactions (mainly at the injection site).
Maltese: Fir-rigward tas-sigurtà, is-CHMP ikkunsidra li l-profil tas-sigurtà ġenerali ta' Hexyon huwa simili għal dawk ta' vaċċini oħra, għalkemm it-tilqim b'Hexacima għandu probabilità ogħla minn vaċċini simili li jikkaġuna reazzjonijiet (l-aktar fis-sit tal-injezzjoni).
English: What benefits of Hexyon have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Hexyon li ħarġu mill-istudji?
English: The studies showed that protective antibody levels against the various diseases developed in between 90 and 100% of children after the first three doses of Hexyon; protection was maintained or improved when a booster dose was given.
Maltese: L-istudji wrew li livelli ta' antikorpi protettivi kontra l-mard differenti żviluppaw f'bejn 90% u 100% tat-tfal wara l-ewwel tliet dożi ta' Hexyon; il-protezzjoni nżammet jew tjiebet meta ngħatat doża booster.
English: What measures are being taken to ensure the safe and effective use of Hexyon?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Hexyon?
English: Hexyon is given by deep injection into a muscle, normally in the upper thigh or the shoulder.
Maltese: Hexyon jingħata permezz ta' injezzjoni fil-fond f'muskolu, normalment fin-naħa ta' fuq tal-koxxa jew fl-ispalla.
English: The most common side effects with Hexyon include pain and redness at the site of injection, irritability and crying.
Maltese: L-effetti sekondarji l-aktar komuni b'Hexyon jinkludu wġigħ u ħmura fis-sit tal-injezzjoni, irritabilità u biki.
English: Hexyon contains small amounts of materials derived from the bacteria and viruses it protects against.
Maltese: Hexyon fih ammonti żgħar ta' materjali meħudin millvirusijiet u l-batterji li hu jipproteġi kontrihom.
English: It is not intended to provide practical advice on how to use Hexyon.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Hexyon.
English: Further information on Lynparza can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lynparza.
Maltese: Aktar informazzjoni dwar Lynparza tinstab fis-sit web talAġenzija: ema.europa.eu/medicines/human/EPAR/lynparza.
English: Lynparza contains the active substance olaparib.
Maltese: Lynparza fih is-sustanza attiva olaparib.
English: Lynparza is available as tablets (100 and 150 mg) and capsules (50 mg) which the patient takes twice a day.
Maltese: Lynparza jiġi bħala pilloli (100 u 150 mg) u kapsuli (50 mg) li l-pazjent jieħu darbtejn kuljum.
English: The doses in milligrams are different for the tablets and capsules.
Maltese: Id-dożi f'milligrammi huma differenti għall-pilloli u l-kapsuli.
English: Other information about Lynparza
Maltese: Informazzjoni oħra dwar Lynparza
English: The most common side effects with Lynparza (which may affect more than 1 in 10 people) are tiredness, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (heartburn), cough, headache, dysgeusia (taste disturbances), decreased appetite, dizziness, upper abdominal pain (stomach ache), dyspnoea (difficulty breathing), anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and thrombocytopenia (low blood platelet counts).
Maltese: L-effetti sekondarji l-aktar komuni b'Lynparza (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma għeja, nawżja (tħossok ma tiflaħx), rimettar, dijarea, dispepsja (ħruq ta' stonku), sogħla, uġigħ ta' ras, disgewżja (disturbi fit-togħma), tnaqqis fl-aptit, sturdament, uġigħ fl-addome ta' fuq (uġigħ flistonku), dispnea (diffikultà fit-teħid tan-nifs), anemija (għadd baxx ta' ċelloli ħomor tad-demm), lewkopenja (għadd baxx ta' ċelloli bojod tad-demm), newtropenja (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm li tiġġieled l-infezzjoni) u t-tromboċitopenija (għadd baxx tal-pjastrini fiddemm).
English: Lynparza received a marketing authorisation valid throughout the EU on 16 December 2014.
Maltese: Lynparza rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-16 ta' Diċembru 2014.
English: • In a third study involving 391 patients with advanced cancer who had BRCA1/2 mutations, the disease had not got worse in around 74% of patients who took Lynparza for 2 years compared with 35% of patients on placebo.
Maltese: • Fit-tielet studju li involva 391 pazjent b'kanċer avvanzat li kellhom il-mutazzjonijiet BRCA1/2, ilmarda ma marritx għall-agħar f'madwar 74 % tal-pazjenti li ħadu Lynparza għal sentejn meta mqabbla ma' 35 % tal-pazjenti fuq il-plaċebo.
English: Ovarian cancer
Maltese: Kanċer tal-ovarji
English: What are the risks associated with Lynparza?
Maltese: X'inhuma r-riskji assoċjati ma' Lynparza?
English: Lynparza was effective in a study involving 302 patients with HER2-negative breast cancer with BRCA1/2 mutations whose cancer had spread.
Maltese: Lynparza kien effettiv fi studju li involva 302 pazjenti b'kanċer tas-sider negattiv għall-HER2 b'mutazzjonijiet BRCA1/2 li l-kanċer tagħhom kien infirex.
English: • In another study involving 265 patients with relapsed cancer, those who took Lynparza lived on average for 8.4 months without their disease getting worse compared with 4.8 months for patients on placebo.
Maltese: • Fi studju ieħor li involva 265 pazjent b'kanċer rikadut, dawk li ħadu Lynparza għexu medja ta' 8.4 xhur mingħajr ma l-marda tagħhom marret għall-agħar meta mqabbla ma' 4.8 xhur għal pazjenti fuq il-plaċebo.