FrancophonIA/ELRC3.0 huggingface dataset:
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Maltese: Fi CURE, CLARITY, ACTIVE-A u wieħed mill-istudji ta' koorti (Trenk), l-ebda każ ta' żieda fir-rata ma ġie osservat li kien ibbażat fuq stat ta' metabolizzatur.
English: Medicinal products associated with bleeding risk: There is an increased risk of bleeding due to the potential additive effect.
Maltese: Hemm żieda fir-riskju ta' fsada minħabba l potenzjal ta' effett addizzjonali.
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach,
Maltese: o inibitur selettiv tal-ġbir mill-ġdid ta' serotonin (li jinkludi iżda mhux limitat għal fluoxetine jew fluvoxamine), mediċini li ssoltu jintużaw fil-kura tad-dipressjoni, - omeprazole jew esomeprazole, mediċini li jittrattataw it-taqlib fl-istonku.
English: The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Maltese: Il-half-life ta' eliminazzjoni talmetabolit ċirkolanti ewlieni (mhux attiv) kien ta' 8 sigħat wara amministrazzjoni waħda u ripetuta.
English: Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, as measured by ex vivo platelet aggregation assays, differ according to CYP2C19 genotype.
Maltese: Il-farmakokinetiċi tal-metabolit attiv ta' clopidogrel u l-effetti kontra l-plejtlets, kif imkejla b'assaġġi ta' aggregazzjoni ta' plejtlets eks vivo, ivarjaw skont il-ġenotip ta' CYP2C19.
English: If you become pregnant while taking Clopidogrel Teva Pharma, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Maltese: Jekk tinqabad tqila waqt li qed tieħu Clopidogrel Teva Pharma, ikkonsulta t-tabib tiegħek minnufih peress li hu rakkomandat li clopidogrel ma jittieħidx meta tkun tqila.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28x1 film-coated tablets)
Maltese: FOLJA (28x1 pillola miksija b'rita)
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Pharma 75 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Clopidogrel Teva Pharma 75 mg pilloli miksija b'rita
English: Rare side effect (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Maltese: Effetti kollaterali rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna) Vertiġini, tkabbir tas-sider fl-irġiel.
English: EU/1/09/561/008 Cartons of 90 film-coated tablets in OPA/Al/PVC - Al blisters
Maltese: Kartun ta' 50 pillola miksija b'rita f'folji tal-in OPA/Al/PVC - Al EU/1/09/561/006
English: EU/1/09/561/003 Cartons of 28 film-coated tablets in OPA/Al/PVC - Al blisters
Maltese: Kartun ta' 30 pillola miksija b'rita f'folji tal-in OPA/Al/PVC - Al EU/1/09/561/005
English: Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Maltese: Minħabba r-riskju ta' reazzjonijiet emorraġiji u effetti ematoloġiċi avversi , l-għadd ta' ċelluli taddemm u/jew kull ittestjar ieħor xieraq għandhom jiġu kkonsidrati kull meta waqt it-trattament ikun hemm sintomi kliniċi li jindikaw emorraġiji (ara sezzjoni 4.8).
English: Clopidogrel Teva Pharma is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: Clopidogrel Teva Pharma jittieħed minn adulti sabiex jevita li jiġu ffurmati emboli tad-demm (trombi) b'vażi tad-demm li qed jibbiesu (arterji), proċess magħruf bħala aterosklerosi, li jista' jwassal għal każijiet arterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: Tests are available to identify a patient's CYP2C19 genotype.
Maltese: Jistgħu jsiru tests sabiex jiġi stabbilit l-ġenotip CYP2C19 ta' pazjent.
English: OTHER
Maltese: Tli
English: Clopidogrel has been evaluated for safety in more than 44,000 patients, who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Maltese: Clopidogrel ġie evalwat għas-sigurta` f'iktar minn 44,000 pazjent li pparteċipaw fi studji kliniċi, inklużi iktar minn 12,000 pazjent li kienu kkurati bih għal sena jew iktar.
English: How to take Clopidogrel Teva Pharma
Maltese: X'fih Clopidogrel Teva Pharma
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Teva Pharma in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Maltese: Jekk ħassejt uġigħ qawwi f'sidrek (anġina mhux stabbli jew attakk tal-qalb), jista' jingħatalek Clopidogrel Teva Pharma flimkien ma' acetylsalicylic acid, sustanza inkorporata f'ħafna mediċini użati biex itaffu l-uġigħ u jnaqqsu d-deni.
English: Calendar days Mon
Maltese: Jiem fil-kalendarju Tne
English: There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers or antacids interfere with antiplatelet activity of clopidogrel.
Maltese: Mhemmx evidenza li prodotti mediċinali oħra li jnaqqsu l-aċidu mill-istonku bħal imblokkaturi ta' H2 jew antaċidi jinterferixxu mal-attività kontra l-plejtlets ta' clopidogrel.
English: Powder: 220 mg Solvent:5 ml
Maltese: Trab: 220 mg Solvent: 5 ml
English: 4 vials powder+ 4 vials solvent + 8 disposable 3 ml syringes + 8 disposable 27-gauge, ½ inch needles
Maltese: 4 kunjetti bit-trab + 4 kunjetti bis-solvent + 8 siringi ta' 3 ml li jintremew wara li jintużaw + 8 labriet ta' 1.3 ċm li jintremew wara li jintużaw, ta' 27 gauge
English: Subcutaneous use Powder: vial (glass) Solvent: LDPE vial
Maltese: Trab: kunjett (ħġieġ) Solvent:
English: 7.5 microgram**
Maltese: 7.5 mikrogrammi**
English: System Organ Class (SOC)
Maltese: Sistema tal-Klassifika tal-Organi (SOC)
English: Day 180
Maltese: Jum 180
English: Class effects:
Maltese: Effetti tal-klassi:
English: 18 - 59 years
Maltese: 18 - 59 sena
English: Strain A/Indonesia/05/2005
Maltese: Razza A/Indoneżja/05/2005
English: 3 - 8 years
Maltese: 3 - 8 snin
English: The following age groups will be used: < 2 years, 2-8 years, ≥ 9 years.
Maltese: Il-gruppi ta' etajiet li ġejjin ser jintużaw: < sentejn, 2-8 snin, > 9 snin.
English: - Guillain-Barré syndrome:
Maltese: - Sindromu ta' Guillain-Barré:
English: Month 12-15
Maltese: Xahar 12-15
English: Children and adolescents aged 3 to 17 years:
Maltese: Tfal u adolexxenti ta' età minn 3 sa 17-il sena:
English: 60 years and above
Maltese: 60 sena u iżjed
English: - Bell's palsy:
Maltese: - Paralisi ta' Bell:
English: A/Vietnam A/Indonesia A/Vietnam A/Indonesia A/Vietnam A/Indonesia
Maltese: A/Vjetnam A/Indoneżja A/Vjetnam A/Indoneżja A/Vjetnam A/Indoneżja
English: Very rare: vasculitis with transient renal involvement.
Maltese: Rari ħafna: vaskulite b'involviment renali temporanju.
English: • abnormal, reduced sensation
Maltese: • sensazzjoni anormali u mnaqqsa
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 October 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta' Ottubru, 2009
English: 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 <1/1000)
English: PT “Bell's palsy”
Maltese: “Paralisi ta' Bell” PT
English: Seroprotection*/
Maltese: Seroprotezzjoni*
English: Immunogenicity in immunocompromised subjects (N=122) and in patients with chronic disease conditions (N=123)
Maltese: Immunoġeniċità f'persuni immunokompromessi (N=122) u f'pazjenti b'kundizzjonijiet ta' mard kroniku (N=123)
English: A/Vietnam A/Indonesia
Maltese: A/Vjetnam A/Indoneżjia
English: Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation)
Maltese: Anormalitajiet sensorjali (parastesija, disestesija, disestesija orali, ipoestesija, disġewsija, u sensazzjoni ta' ħruq) Sinkope
English: In a clinical trial 300 adolescents aged 9 to 17 years and 153 children aged 3 to 8 years were administered the H5N1 vaccine.
Maltese: Fi prova klinika 300 adolexxent minn 9 sa 17-il sena u 153 tifel u tifla ta' età minn 3 sa 8 snin ingħataw il-vaċċin H5N1.
English: Immunogenicity in adults aged 18 to 59 years (N=961) and in subjects aged 60 years and older (N=391)
Maltese: Immunoġeniċità f'persuni adulti li għandhom 18 sa 59 sena (N=961) u f'persuni li għandhom 60 sena u aktar (N=391)
English: Antibody persistence
Maltese: Persistenza tal-antipkorpi
English: • Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Maltese: • Wara t-tilqim kontra l-influwenza, kienu osservati riżultati pożittivi foloz f'testijiet seroloġiċi li jużaw il-metodu ELISA biex jirrilevaw antikorpi kontra l-HIV1, l-Epatite Ċ u speċjalment l-HTLV1.
English: Month 24 * SRH area ≥ 25 mm² ** MN titre ≥ 20
Maltese: Xahar 24 * żona SRH ≥ 25 mm² ** tajter MN ≥ 20
English: narrow SMQ “Guillain-Barré syndrome”
Maltese: “Sindromu ta' Guillain-Barré” SMQ dejjaq
English: - First data-lock point is 30 days later.
Maltese: - L-ewwel data lock point hu 30 jum wara.
English: SRH assay
Maltese: Assaġġ SRH
English: One dose of 0.5 ml will be given.
Maltese: Se tingħata doża waħda ta' 0.5 ml.
English: per 0.5 ml dose
Maltese: għal kull doża ta' 0.5 ml
English: Seroneutralisation rate* Immunocompromised subjects
Maltese: Ir-rata ta' seronewtralizzazzjoni* Persuni immunokompromessi
English: Tested against
Maltese: Ittestjati kontra
English: Microneutralisation Assay Immunocompromised subjects
Maltese: Assaġġ tal-mikronewtralizzazzjoni Persuni immunokompromessi
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR(I) RESPONSABBLI
English: Immune response against the vaccine strain contained in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (A/Vietnam/1203/2004)
Maltese: Rispons immunitarju kontra r-razza tal-vaċċin li jinstab fil-PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (A/Vjetnam/1203/2004)
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Maltese: - Ir-rapport ta' stima tar-Rapporter għandu jiġi ċirkolat lil membri CHMP f'Jum 50.
English: Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years and older:
Maltese: Trabi, tfal u adolexxenti ta' età minn 6 xhur sa 17-il sena u adulti minn 18-il sena 'l fuq:
English: Skin and subcutaneous tissue disorders: angioedema Musculoskeletal and connective tissue disorders: pain in extremity Trivalent seasonal influenza vaccines
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda: anġjoedema Disturbi muskolu-skeletriċi u tat-tessuti konnettivi: uġigħ fl-estremitajiet Vaċċin trivalenti kontra influwenza staġjonali
English: GASTROINTESTINAL DISORDERS
Maltese: GASTRO-INTESTINALI Dijarea
English: Adults, older people and special risk groups
Maltese: Adulti, persuni akbar fl-età u gruppi f'riskju speċjali
English: Infants, children, and adolescents Immune response against A/Vietnam/1203/2004 (H5N1)
Maltese: Rispons immunitarju kontra A/Vjetnam/1203/2004 (H5N1)
English: • swollen glands
Maltese: • tħossok għajjien
English: 12 - 24 months booster * MN titre ≥ 20
Maltese: Booster wara 12 - 24 xahar * Tajter MN ≥ 20
English: • vomiting, feeling sick, diarrhoea
Maltese: • rimettar, tħossok imdardar, dijarea
English: Seroneutralisation rate* * MN titre ≥ 20
Maltese: Ir-rata ta' seronewtralizzazzjoni* * tajter MN ≥ 20
English: Malaise
Maltese: DISTURBI
English: The symptoms (signs) of pandemic flu are similar to those of an ‘ordinary' flu but are usually more severe.
Maltese: Is-sintomi (sinjali) tal-influwenza pandemika huma bħal dawk ta' influwenza ‘ordinarja' iżda normalment ikunu iktar severi.
English: • insomnia (difficulty sleeping)
Maltese: • insomnja (diffikultà biex torqod)
English: The ferrets were challenged intranasally on day 35 with a high dose of either the clade 2 H5N1 virus A/Indonesia/05/2005 or the clade 1 H5N1 virus A/Vietnam/1203/2004 and monitored for 14 days.
Maltese: F'jum 35, linmsa ġew sfidati mill-imnieħer b'doża qawwija jew virus tal-clade 2 H5N1 A/Indoneżja/05/2005 jew virus tal-clade 1 H5N1 A/Vjetnam/1203/2004 u ġew immonitorjati għal 14-il ġurnata.
English: 6 - 35 months
Maltese: 6 - 35 xahar
English: Preferred MedDRA Term
Maltese: Terminu tal-MedDRA Ppreferut
English: narrow SMQ “Vasculitis”
Maltese: “Vaskulite” SMQ dejjaq
English: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Maltese: DISTURBI RESPIRATORJI, TORAĊIĊI
English: Trometamol Sodium chloride Water for injections Polysorbate 80
Maltese: Trometamol sodium chloride ilma għall-injezzjonijiet polysorbate 80
English: Seroprotection rate* Seroconversion rate** Seroconversion factor*** * SRH area ≥ 25 mm² ** either SRH area ≥ 25 mm if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
Maltese: Il-fattur ta' serokonverżjoni*** * erja SRH ≥ 25 mm² ** erja SRH ≥ 25 mm² jekk il-kampjun fil-linja bażi huwa negattiv jew żieda ta' 50% fl-arja SRH jekk il-kampjun tallinja bażi >4 mm² *** żieda fil-medja ġeometrika
English: INFECTIONS AND INFESTATIONS
Maltese: INFEZZJONIJIET U INFESTAZZJONIJIET
English: Immune system disorders: anaphylactic reaction, hypersensitivity
Maltese: Disturbi fis-sistema immuni: reazzjoni anafilattika, sensittività eċċessiva Disturbi fis-sistema nervuża: konvulżjoni
English: The A/Vietnam/1203/2004 vaccine afforded protection against homologous challenge as evidenced by full survivorship, reduced weight loss, a less pronounced and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control animals.
Maltese: Il-vaċċin A/Vjetnam/1203/2004 offra protezzjoni kontra sfida omologa kif muri minn sopravivenza sħiħa, tnaqqis fit-telf tal-piż, żieda inqas evidenti u iqsar fit-temperatura, tnaqqis inqas notevoli fl-għadd ta' limfoċiti u fit-tnaqqis tal-infjammazzjoni u n-nekrożi fil-moħħ u fil-basla olfattorja fil-koorti mlaqqma meta pparagunat mal-annimali ta' kontroll.
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 is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu/.
English: Trometamol, sodium chloride, water for injections, polysorbate 80
Maltese: Trometamol, sodium chloride, ilma għall-injezzjonijiet, polysorbate 80
English: Seroneutralisation rate* Seroconversion rate** Seroconversion factor*** * MN titre ≥ 20 ** ≥ 4-fold increase in MN titre *** geometric mean increase
Maltese: Ir-rata ta' seronewtralizzazzjoni* Ir-rata ta' serokonverżjoni** Il-fattur ta' serokonverżjoni*** * Tajter MN ≥ 1:20 ** ≥ żieda ta' 4 darbiet fit-tajter MN *** żieda fil-medja ġeometrika
English: 9 - 17 years
Maltese: 9 - 17-il sena
English: narrow SMQ “Convulsions”
Maltese: “Konvulżjonijiet” SMQ dejjaq
English: History of an anaphylactic (i.e. life-threatening) reaction to the active substance, to any of the excipients listed in section 6.1 or to trace residues (e.g. formaldehyde, benzonase, sucrose) of this vaccine.
Maltese: Storja ta' reazzjoni anafilattika (jiġifieri ta' theddida għall-ħajja) għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 jew għal residwi fi traċċa (eż. formaldehyde, benzonase, sucrose) ta' dan il-vaċċin.
English: PT “Vaccination failure”.
Maltese: “Falliment tal-vaċċinazzjoni” PT.
English: Animal reproductive and developmental toxicity studies with H5N1 strain vaccines (A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not indicate direct or indirect harmful effects with respect to female fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Maltese: Studji f'annimali dwar effett tossiku fuq is-sistema riproduttiva b'vaċċini kontra razez H5N1 (A/Vjetnam/1203/2004 u A/Indoneżja/05/2005) ma jurux effetti ħżiena diretti jew indiretti fir-rigward tal-fertilità fin-nisa, tqala, żvilupp embrijonali/fetali, żvilupp ta' waqt jew wara t-twelid (ara sezzjoni 5.3).
English: MARKETING AUTHORISATION NUMBER EU/1/09/571/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/571/002
English: - Neuritis:
Maltese: - Enċefalite:
English: 21 days after 2nd dose
Maltese: 21 jum wara tieni doża
English: A/Indonesia
Maltese: A/Vjetnam A/Indoneżja
English: • reduced blood pressure, feeling faint (syncope)
Maltese: • tnaqqis fil-pressjoni tad-demm, ħass ħażin (sinkope)
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for PANDEMIC INFLUENZA VACCINE H5N1 BAXTER takes due account of the officially declared pandemic strain.
Maltese: INFLUENZA VACCINE H5N1 BAXTER jista' jitqiegħed fis-suq biss meta jkun hemm dikjarazzjoni uffiċjali tal-WHO/UE dwar l-influwenza pandemika, bil-kundizzjoni li d-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għal PANDEMIC INFLUENZA VACCINE H5N1 BAXTER jieħu in konsiderazzjoni r-razza pandemika dikjarata uffiċjalment.
English: The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in a clinical trial in children and adolescents aged 9 to 17 years (N=288), in children aged 3 to 8 years (N=146) and in infants and children aged 6 to 35 months (N=33) following a 0, 21 day schedule.
Maltese: L-immunoġeniċità tal-vaċċin kontra r-razza A/Vjetnam/1203/2004 ġiet evalwata fi prova klinika fi tfal u adolexxenti ta' età minn 9 sa 17-il sena (N=288), fi tfal ta' età minn 3 sa 8 snin (N=146) u fi trabi u tfal ta' età minn 6 sa 35 xahar (N=33) billi kienet segwita skeda ta' 0, 21 ġurnata.
English: One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Pakkett wieħed ta' 20 kunjett b'ħafna dożi (ħġieġ ta' Tip I) ta' 5 ml ta' suspensjoni (10 dożi x 0.5 ml) b'tapp (lastku bromobutyl).
English: PT “Neuritis”
Maltese: “Newrite” PT
English: Contents of the pack and other information What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER contains Active substance:
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Sustanza attiva:
English: MARKETING AUTHORISATION NUMBER EU/1/09/571/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/571/001
English: * produced in Vero cells ** haemagglutinin
Maltese: * prodott f'ċelluli Vero ** emaglutinin
English: • conjunctivitis (an inflammation of the eye), eye irritation
Maltese: • konġuntivite (infjammazzjoni tal-għajnejn), irritazzjoni fl-għajnejn
English: The A/lndonesia/05/2005 vaccine was shown to be efficacious with 100% survival, reduced incidence of fever, reduced weight loss, reduced virus burden, and reduced haematological (leukopenia and lymphopenia) changes in the vaccinated cohorts following homologous challenge.
Maltese: Il-vaċċin A/lndonesja/05/2005 intwera li kien effikaċi b'sopravivenza ta' 100%, tnaqqis fl-inċidenza tad-deni, tnaqqis fit-telf tal-piż, tnaqqis fit-tagħbija tal-virus, u tnaqqis fil-bidliet ematoloġiċi (lewkopenija u limfopenija) fil-gruppi mlaqqma wara sfida omologa.
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Maltese: Doża sekondarja ta' 0.5 ml għandha tingħata wara intervall ta' mill-inqas 3 ġimgħat.
English: Common (affects 1 to 10 in 100 vaccinees):
Maltese: Komuni (jaffettwaw minn 1 sa 10 persuni minn kull 100 persuna mlaqqma):
English: Two studies have been performed using either the H5N1 A/Vietnam/1203/2004 or the A/Indonesia/05/2005 vaccine.
Maltese: Saru żewġ studji billi ntużaw il-vaċċin H5N1 A/Vjetnam/1203/2004 jew A/Indoneżja/05/2005.
English: Oropharyngeal pain Rhinorrhoea
Maltese: Uġigħ orofaringolarinġeali Rinorreja
English: The following serious adverse reactions have been reported from post-marketing surveillance with egg-derived interpandemic trivalent vaccines:
Maltese: Ir-reazzjonijiet avversi serji li ġejjin ġew irrappurtati mis-sorveljanza ta' wara t-tqegħid fis-suq b'vaċċini trivalenti interpandemiċi derivati mill-bajd.
English: The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme.
Maltese: L-effetti sekondarji elenkati hawn taħt seħħew b'vaċċin simili tal-influwenza (Celvapan) f'persuni adulti u t-tfal matul il-programm ta' tilqim kontra l-influwenza pandemika (H1N1).
English: - Demyelination:
Maltese: - Demijelinazzjoni:
English: • Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period.
Maltese: • Reazzjonijiet ta' sensittività eċċessiva, li jinkludu anafilassi, ġew irrappurtati wara l-użu ta' vaċċin simili kontra l-influwenza minn H1N1, virjon sħiħ, derivat minn ċelluli Vero, mogħti waqt perjodu pandemiku.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is an off-white, opalescent, translucent liquid.
Maltese: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER huwa likwidu ofwajt, opalexxenti u transluċidu.
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Maltese: “Reazzjoni Anafillatika” SMQ dejjaq u “Anġjoedema” SMQ dejjaq.
English: Antibody persistence after vaccination with the 7.5 µg non-adjuvanted formulation of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in a clinical study in adults aged 18 - 59 years and subjects aged 60 years and above at 6 months, 12 - 15 months and 24 months after the start of the primary vaccination series.
Maltese: Il-persistenza tal-antikorpi wara l-vaċċin bil-formulazzjoni non-adjuvanted ta' 7.5 µg ta' PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (razza A/Vjetnam/1203/2004) ġiet evalwata fi studju kliniċu li sar fuq persuni adulti li kellhom 18 - 59 sena u persuni li kellhom 60 sena jew iżjed wara 6 xhur, 12 - 15-il xahar u 24 xahar wara l-bidu tas-serje tal-vaċċin primarja.
English: The following side effects have been reported in a clinical study in infants aged 6 to 35 months.
Maltese: Ġew irrappurtati dawn l-effetti sekondarji fi istudju kliniku fi trabi ta' età minn 6 sa 35 xahar.
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Maltese: • jekk tkun ser tagħmel xi test tad-demm biex tara hemmx evidenza ta' infezzjoni b'ċerti viruses.
English: In addition, the immunogenicity has also been evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123) following a 0, 21 day schedule.
Maltese: Flimkien ma' dan, l-immunoġeniċità ġiet evalwata wkoll fi studju ta' Fażi 3 fi gruppi speċifiċi ta' riskju ta' persuni immunokompromessi (N=122) u pazjenti b'kundizzjonijiet ta' mard kroniku (N=123) billi kienet segwita skeda ta' 0, 21 ġurnata.
English: Headache
Maltese: DOŻI
English: Immunization should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Maltese: L-immunizzazzjoni għandha ssir permezz ta' injezzjoni ġol-muskoli fil-muskolu deltojde jew fil-koxxa anterolaterali, skont il-massa tal-muskoli.