FrancophonIA/ELRC3.0 huggingface dataset:
English: Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Maltese: Ongentys huwa indikat bħala terapija aġġuntiva għal preparazzjonijiet ta' inibituri ta' levodopa/ DOPA decarboxylase (DDCI) f'pazjenti adulti bil-marda ta' Parkinson u fluttwazzjonijiet motorji fi tmiem tad-doża li ma jkunux jistgħu jiġu stabbilizzati fuq dawn il-kombinazzjonijiet.
English: A single dose study with opicapone 25 mg showed an average increase of 30 % in the rate, but not the extent, of exposure to repaglinide (a CYP2C8 substrate), when the two drugs were co-administered.
Maltese: Studju b'doża waħda ta' opicapone 25 mg wera żieda medja ta' 30 % fir-rata, imma mhux fl-estent, tal-esponiment għal repaglinide (sottostrat ta' CYP2C8), meta ż-żewġ mediċini ġew mogħtija flimkien.
English: OPC 50 mg - placebo
Maltese: OPC 50 mg - Plaċebo
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2).
Maltese: M'hemm l-ebda esperjenza klinika f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh Klass C) (ara sezzjoni 4.2).
English: Opicapone exposure increased in a dose proportional manner following once-daily multiple dose administration up to 50 mg opicapone.
Maltese: L-esponiment ta' opicapone żdied b'mod proporzjonali mad-doża wara l-għoti ta' dożi multipli darba kuljum sa 50 mg ta' opicapone.
English: Note: A responder was a patient who had a reduction of at least 1 hour in absolute OFF-time (OFF-time responder)
Maltese: Nota: Persuna li rrispondiet kien pazjent li kellu tnaqqis ta' mill-inqas siegħa fil-ħin OFF assolut (persuna li rrispondiet b'ħin OFF)
English: Light blue capsules, size 1, approximately 19 mm, imprinted “OPC 25” on the cap and “Bial” on the body.
Maltese: Kapsuli blu ċari, daqs 1, ta' madwar 19 mm, stampati b'”OPC 25” fuq l-għatu u “Bial” fuq il-korp.
English: OPC 25 mg - placebo
Maltese: OPC 25 mg - Plaċebo
English: Abdominal distention, Abdominal pain, Abdominal pain upper, Dyspepsia
Maltese: Nefħa addominali, Uġigħ addominali, Uġigħ addominali finnaħa ta' fuq, Dispepsija
English: In vitro studies have shown that opicapone is not transported by OATP1B1, but is transported by OATP1B3, and efflux transported by P-gp and BCRP.
Maltese: Studji in vitro wrew li opicapone ma jiġix ittrasportat minn OATP1B1, iżda hu ttrasportat minn OATP1B3, ttrasportat ‘il barra (efflux transported) minn P-gp u BCRP.
English: The efficacy and safety of opicapone has been demonstrated in two Phase 3 double-blind, placebo and active (Study 1 only) controlled studies in 1,027 randomized adult patients with Parkinson's disease treated with levodopa/DDCI (alone or in combination with other antiparkinsonian drugs) and end-ofdose motor fluctuations for up to 15 weeks.
Maltese: L-effikaċja u s-sigurtà ta' opicapone ntweriet f'żewġ studji ta' Fażi 3, double-blind, bi plaċebo bħala kontroll u kif ukoll b'sustanza attiva (Studju 1 biss) li saru fuq 1,027 pazjent adult randomised, bil-marda ta' Parkinson, ittrattati b'levodopa/DDCI (waħdu jew flimkien ma' mediċini oħrajn kontra l-marda ta' Parkinson) u bi fluttwazzjonijiet motorji fit-tmiem tad-doża għal sa 15-il ġimgħa. Fliscreening, l-età medja kienet simili fil-gruppi kollha tat-trattament fiż-żewġ studji, u kienet tvarja bejn 61.5 u 65.3 sena.
English: The pharmacokinetics of opicapone was evaluated in healthy subjects and moderate chronic hepatic impaired patients after administration of a single-dose of 50 mg.
Maltese: Il-farmakokinetika ta' opicapone ġiet evalwata f'individwi b'saħħithom u f'pazjenti b'indeboliment moderat kroniku tal-fwied wara l-għoti ta' doża waħda ta' 50 mg.
English: However, clinical interaction studies conducted with warfarin showed no effect of opicapone on the pharmacodynamics of warfarin, a substrate of CYP2C9.
Maltese: Madankollu, studji dwar interazzjonijiet kliniċi li saru b'warfarin ma wrew l-ebda effett ta' opicapone fuq il-farmakodinamika ta' warfarin, sottostratt ta' CYP2C9.
English: Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor endowed with a high binding affinity (sub-picomolar) that translates into a slow complex dissociation rate constant and a long duration of action (>24 hours) in vivo.
Maltese: Opicapone hu inibitur periferali, selettiv u riversibbli ta' catechol-O-methyltransferase (COMT), mogħni b'affinità għolja ta' twaħħil (sottopikomolari) li tissarraf f'kostant ta' dissoċjazzjoni bil-mod u kumpless u żmien twil ta' azzjoni (> 24 siegħa) in vivo.
English: (only for outer packaging)
Maltese: [mhux assenjat]
English: Blisters: 10 or 30 capsules.
Maltese: Fliexken: 10 jew 30 kapsula.
English: Ongentys 25 mg capsules opicapone
Maltese: Ongentys 25 mg kapsuli opicapone
English: Do not use this medicine after the expiry date which is stated on the bottle/blister/carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna wara EXP.
English: Ongentys 50 mg capsules opicapone
Maltese: Ongentys 50 mg kapsuli opicapone
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX (BLISTER OPA/Al/PVC//Al)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA (FOLJA TAL-OPA/Al/PVC//Al)
English: Dark blue capsules, size 1, approximately 19 mm, imprinted “OPC 50” on the cap and “Bial” on the body.
Maltese: Kapsuli blu skuri, daqs 1, ta' madwar 19 mm, stampati b'”OPC 50” fuq l-għatu u “Bial” fuq il-korp.
English: The LS mean reduction in absolute OFF-time from baseline to endpoint in the entacapone group was -78.7 minutes.
Maltese: Il-medja tat-tnaqqis f'LS fil-ħin OFF assolut mil-linja bażi sal-punt aħħari fil-grupp ta' entacapone kienet ta' -78.7 minuti.
English: The recommended dose of opicapone is 50 mg.
Maltese: Id-doża rakkomandata ta' opicapone hija ta' 50 mg.
English: BIA 9-1103 plasma levels were not affected in patients with chronic renal impairment, and as such, no dose adjustment needs to be considered.
Maltese: Il-livelli ta' BIA 9-1103 fil-plażma ma ġewx affettwati f'pazjenti b'indeboliment kroniku tal-kliewi, u għaldaqstant, m'hemmx bżonn li jiġi kkunsidrat l-ebda aġġustament fid-doża.
English: Taking Ongentys with these medicines may increase the risk of side effects.
Maltese: Li tieħu Ongentys ma' dawn il-mediċini jista' jżid ir-riskju ta' effetti sekondarji.
English: Ongentys 50 mg hard capsules are dark blue, approximately 19 mm length, with “OPC 50” and “Bial” printed on the capsules.
Maltese: Kif jidher Ongentys u l-kontenut tal-pakkett Ongentys 50 mg kapsuli ibsin ta' lewn blu skur, b'tul ta' madwar 19 mm, b'“OPC 50” u “Bial” stampati fuq il-kapsuli.
English: Opicapone may, together with levodopa, cause dizziness, symptomatic orthostatism and somnolence.
Maltese: Opicapone jista', flimkien ma' levodopa, jikkawża sturdament, ortostatiżmu sintomatiku u ngħas.
English: In urine, the primary metabolite was the glucuronide metabolite of opicapone, while parent drug and other metabolites were generally below the limit of quantification.
Maltese: Fl-awrina, il-metabolit primarju kien il-metabolit glucuronide ta' opicapone, filwaqt li l-mediċina prinċipali u metaboliti oħrajn kienu ġeneralment taħt il-limitu ta' kwantifikazzjoni.
English: There is no relevant use of Ongentys in the paediatric population with Parkinson's disease and motor fluctuations.
Maltese: M'hemm l-ebda użu rilevanti ta' Ongentys fil-popolazzjoni pedjatrika bil-marda ta' Parkinson u fluttwazzjonijiet motorji.
English: In patients taking levodopa and a peripheral DDCI, such as carbidopa or benserazide, opicapone increases levodopa plasma levels thereby improving the clinical response to levodopa.
Maltese: F'pazjenti li jkunu qed jieħdu levodopa u DDCI periferali, bħal carbidopa jew benserazide, opicapone jżid il-livelli ta' levodopa fil-plażma u b'hekk itejjeb ir-rispons kliniku għal levodopa.
English: Other levodopa medicines
Maltese: IL-PRODOTT MEDIĊINALI
English: - if you have a tumour of the adrenal gland (known as phaeochromocytoma), or of the nervous system (known as paraganglioma), or any other tumour which increase the risk of severe high blood pressure; - if you have ever suffered from neuroleptic malignant syndrome which is a rare reaction to antipsychotic medicines; - if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury; - if you are taking certain antidepressants called monoamine-oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine or moclobemide).
Maltese: Tiħux Ongentys: - jekk inti allerġiku għal opicapone jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6); - jekk għandek tumur tal-glandola adrenali (magħruf bħala phaeochromocytoma), jew tas-sistema nervuża (magħruf bħala paraganglioma), jew kwalunkwe tumur ieħor li jżid ir-riskju ta' pressjoni tad-demm għolja severa; - jekk qatt batejt minn sindrome newrolettika malinna (neuroleptic malignant syndrome) li hi reazzjoni rari għal mediċini antipsikotiċi; - jekk qatt batejt minn disturb muskolari rari msejjaħ rabdomijolożi li ma kienx ikkawżat minn ferita;
English: Ongentys 25 mg hard capsules are light blue, approximately 19 mm length, with “OPC 25” and “Bial” printed on the capsules.
Maltese: Kif jidher Ongentys u l-kontenut tal-pakkett Ongentys 25 mg kapsuli ibsin ta' lewn blu ċar, b'tul ta' madwar 19 mm, b'“OPC 25” u “Bial” stampati fuq il-kapsuli.
English: - dizziness - headache - sleepiness - difficulty falling or staying asleep - strange dreams - experiencing or seeing things which do not exist (hallucinations) - a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting Uncommon: may affect up to 1 in 100 people - palpitations or irregular heartbeat - blocked ear - dry eye - pain or swelling of the abdomen - indigestion - weight loss - loss of appetite - increased levels of triglycerides (fats) in your blood - muscle twitching, stiffness or pain - pain in arms or legs - altered sense of taste - excessive body movements - fainting - anxiety - depression - hearing things which do not exist - nightmares - sleep disorder - abnormal colour of urine - need to wake and pass urine at night - shortness of breath - high or low blood pressure
Maltese: - żieda fil-livelli ta' trigliċeridi (xaħmijiet) fid-demm tiegħek - kontrazzjonijiet, ebusija jew uġigħ fil-muskoli - uġigħ fid-dirgħajn jew fir-riġlejn - tibdil fis-sens ta' togħma - movimenti eċċessivi tal-ġisem - ħass ħażin - ansjetà - dipressjoni - tisma' affarijiet li ma jeżistux - ħolm ikrah - problemi biex torqod - kulur mhux normali tal-awrina - bżonn li tqum u tagħmel l-awrina bil-lejl - qtugħ ta' nifs - pressjoni tad-demm għolja jew baxxa
English: White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10, 30 or 90 capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Fliexken bojod tal-polyethylene ta' densità għolja (HDPE) b'għotjien tal-polypropylene (PP) li huma reżistenti għat-tfal, li jkun fihom 10, 30 jew 90 kapsula.
English: To reduce levodopa-related dopaminergic adverse reactions (e.g. dyskinesia, hallucinations, nausea, vomiting and orthostatic hypotension), it is often necessary to adjust the daily dose of levodopa by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating treatment with Ongentys, according to the clinical condition of the patient (see section 4.2).
Maltese: Biex jitnaqqsu reazzjonijiet avversi dopaminerġiċi relatati ma' levodopa (eż. dyskinesia, alluċinazzjonijiet, dardir, rimettar u pressjoni baxxa ortostatika), ta' spiss ikun meħtieġ li d-doża ta' kuljum ta' levodopa tiġi aġġustata billi l-intervalli tad-dożaġġ jiġu estiżi u/jew jitnaqqas lammont ta' levodopa f'kull doża fl-ewwel ftit jiem sa l-ewwel ġimgħat wara li jinbeda t-trattament b'Ongentys, skont il-kundizzjoni klinika tal-pazjent (ara sezzjoni 4.2).
English: Each capsule contains 50 mg of opicapone.
Maltese: Kull kapsula iebsa fiha 50 mg ta' opicapone.
English: EU/1/15/1066/001 10 hard capsules EU/1/15/1066/008 30 hard capsules
Maltese: EU/1/15/1066/008 30 kapsula ibsin
English: Opicapone demonstrated clinical efficacy superior to placebo during the double-blind treatment, both for the primary efficacy variable used in both pivotal studies, i.e. reduction in OFF-time (Table 2), the proportion of OFF-time responders (i.e. a subject who had a reduction in OFF-time of at least 1 hour from baseline to endpoint) (Table 3) and for most diary-derived secondary endpoints.
Maltese: Opicapone wera effikaċja klinika superjuri għall-plaċebo matul it-trattament double-blind, kemm għall-varjabbli tal-effikaċja primarja użata fiż-żewġ studji importanti ħafna, i.e. tnaqqis fil-ħin OFF (Tabella 2), il-proporzjon ta' persuni li rrispondew b'ħin OFF (i.e. individwu li kellu tnaqqis fil-ħin OFF ta' mill-inqas siegħa mil-linja bażi sal-punt aħħari) (Tabella 3) u għall-biċċa l-kbira tal-punti aħħarin sekondarji miksuba mid-djarju.
English: Some side effects may be caused by the increased effects of using Ongentys together with levodopa.
Maltese: Xi effetti sekondarji jistgħu jiġu kkawżati miż-żieda fl-effetti li tuża Ongentys flimkien ma' levodopa.
English: Each capsule contains 25 mg of opicapone.
Maltese: Kull kapsula iebsa fiha 25 mg ta' opicapone.
English: If Ongentys is discontinued it is necessary to adjust the dosing of the other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the symptoms.
Maltese: Jekk Ongentys jitwaqqaf, ikun meħtieġ li jiġi aġġustat id-dożaġġ ta' trattamenti oħrajn ta' kontra lmarda ta' Parkinson, speċjalment levodopa, sabiex jinkiseb livell suffiċjenti ta' kontroll tas-sintomi.
English: HDPE bottles: 3 years Blisters: 5 years
Maltese: Folji: 5 snin
English: Very common: may affect more than 1 in 10 people - involuntary and uncontrollable, or difficult or painful body movements
Maltese: Komuni ħafna: jistgħu jaffettwaw aktar minn persuna waħda minn kull 10 - movimenti involontarji u inkontrollabbli, jew movimenti tal-ġisem diffiċli jew bl-uġigħ
English: EU/1/15/1066/009 10 hard capsules EU/1/15/1066/010 30 hard capsules
Maltese: EU/1/15/1066/010 30 kapsula ibsin
English: The remainder of the radioactivity was excreted in urine (mean 12.8%) and via expired air (mean 15.9%).
Maltese: Il-bqija tar-radjuattività ġiet eliminata fl-awrina (medja ta' 12.8%) u permezz tat-teħid tannifs 'il barra (medja ta' 15.9%).
English: Children and adolescents under the age of 18 years must not take this medicine as it has not been studied in these age groups.
Maltese: Tfal u adolexxenti taħt l-età ta' 18-il sena m'għandhomx jieħdu din il-mediċina billi ma ġietx studjata f'dawn il-gruppi ta' etajiet.
English: Bial - Portela & Cª., S.A.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Bial - Portela & Cª, S.A.
English: The pharmacokinetics of opicapone was not directly evaluated in subjects with chronic renal impairment.
Maltese: Il-farmakokinetika ta' opicapone ma ġietx evalwata b'mod dirett f'individwi b'indeboliment kroniku tal--kliewi.
English: Uncommon: may affect up to 1 in 100 people - palpitations or irregular heartbeat - blocked ear - dry eye - pain or swelling of the abdomen - indigestion - weight loss - loss of appetite - increased levels of triglycerides (fats) in your blood - muscle twitching, stiffness or pain - pain in arms or legs - altered sense of taste - excessive body movements - fainting - anxiety - depression - hearing things which do not exist - nightmares - sleep disorder - abnormal colour of urine - need to wake and pass urine at night - shortness of breath - high or low blood pressure
Maltese: Komuni: jistgħu jaffettwaw sa persuna waħda minn kull 10 - stitikezza - ħalq xott - rimettar (tkun imdardar u tirremetti) - żieda fil-livelli tal-enzima (creatine kinase) fid-demm tiegħek - spażmi tal-muskoli - sturdament - uġigħ ta' ras - ngħas - diffikultà biex torqod jew biex tibqa' rieqed - ħolm stramb - tgħaddi minn esperjenzi jew tara affarijiet li ma jeżistux (alluċinazzjonijiet) - tnaqqis fil-pressjoni tad-demm malli tqum bilwieqfa li tikkawża sturdament, jew ħass ħażin
English: A study conducted in healthy volunteers showed that when a single dose of 50 mg opicapone was coadministered (within 1 hour) with a single dose of quinidine (600 mg), systemic exposure of opicapone decreased by 37% (AUC0-tlast).
Maltese: Studju li twettaq f'voluntiera f'saħħithom wera li meta doża waħda ta' 50 mg opicapone ġiet mogħtija flimkien (fi żmien siegħa) ma' doża waħda ta' quinidine (600 mg), l-esponiment sistemiku ta' opicapone naqas b'37% (AUC0-tlast).
English: Dose adjustments of antiparkinsonian therapy
Maltese: Aġġustamenti fid-doża tat-terapija kontra l-marda ta' Parkinson
English: Ongentys may increase its effect; - medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria.
Maltese: Ongentys jista' jżid l-effett tagħha; - mediċini li fihom quinidine, mediċina li tintuża fit-trattament ta' ritmi tal-qalb mhux normali jew malarja.
English: a. ON-time without troublesome dyskinesias=ON-time with non-troublesome dyskinesias + ON-time without dyskinesias
Maltese: Ħin ON mingħajr dyskinesias li jikkawżaw problemi=ħin ON b'dyskinesias li ma jikkawżawx problemi + ħin ON mingħajr dyskinesias
English: Ongentys may increase their effects; - medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ongentys may increase their effects; - medicines that affect the immune system such as methotrexate.
Maltese: Ongentys jista' jżid l-effetti tagħhom; - mediċini kontra kolesterol għoli bħal rosuvastatin, simvastatin, atorvastatin jew pravastatin.
English: There is no experience taking Ongentys and safinamide together.
Maltese: Aħżen fil-folja oriġinali sabiex tilqa' mill-umdità.
English: Because of this, concomitant use of opicapone with MAO inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson's disease is contraindicated.
Maltese: Minħabba f'dan, l-użu flimkien ta' opicapone ma' inibituri ta' MAO (eż. phenelzine, tranylcypromine and moclobemide) apparti dawk għat-trattament tal-marda ta' Parkinson, hu kontraindikat (ara sezzjoni 4.5).
English: The recommended dose is 50 mg once daily.
Maltese: Id-doża rakkomandata hi ta' 50 mg darba kuljum.
English: ongentys 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE ongentys 25 mg
English: Ongentys may increase their effect; - medicines used to treat heart failure such as dobutamine, dopamine or dopexamine.
Maltese: Ongentys jista' jżid leffett tagħhom; - mediċini li jintużaw għall-kura ta' insuffiċjenza tal-qalb bħal dobutamine, dopamine jew dopexamine.
English: EU/1/15/1066/002 10 hard capsules EU/1/15/1066/003 30 hard capsules EU/1/15/1066/004 90 hard capsules
Maltese: EU/1/15/1066/003 30 kapsula ibsin
English: Dyspnoea
Maltese: Piż
English: EU/1/15/1066/005 10 hard capsules EU/1/15/1066/006 30 hard capsules EU/1/15/1066/007 90 hard capsules
Maltese: EU/1/15/1066/006 30 kapsula ibsin
English: Animal studies with opicapone do not indicate harmful effects with respect to fertility (see section 5.3).
Maltese: Studji b'opicapone fuq l-annimali ma jurux effetti ħżiena fir-rigward tal-fertilità (ara sezzjoni 5.3).
English: Ongentys 50 mg hard capsules
Maltese: Ongentys 50 mg kapsuli ibsin
English: Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati regolarment għall-iżvilupp ta' disturbi fil-kontroll tal-impulsi, u reviżjoni tat-trattament hi rakkomandata jekk dawn is-sintomi jiżviluppaw.
English: EU/1/08/505/004 EU/1/08/505/005 EU/1/08/505/006
Maltese: EU/1/08/505/005 EU/1/08/505/006
English: Organ class
Maltese: Klassi tal-organi
English: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, France.
Maltese: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, Franza.
English: EU/1/08/505/004 - pack of 1 pre-filled syringe with a Micro-Injection System EU/1/08/505/005 - pack of 10 pre-filled syringes with a Micro-Injection System EU/1/08/505/006 - pack of 20 pre-filled syringes with a Micro-Injection System
Maltese: EU/1/08/505/004 - pakkett ta' siringa mimlija għal-lest b'Sistema ta' Mikro-Injezzjoni EU/1/08/505/005 - pakkett ta' 10 siringi mimlijin għal-lest b'Sistema ta' Mikro-Injezzjoni EU/1/08/505/006 - pakkett ta' 20 siringa mimlijin għal-lest b'Sistema ta' Mikro-Injezzjoni
English: The safety of INTANZA has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of INTANZA.
Maltese: Is-sigurtà ta' INTANZA ġiet evalwata fi 3 provi kliniċi open-label u randomizzati li fihom, 3,372 pazjent irċivew injezzjoni ta' INTANZA.
English: The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination during clinical trials and worldwide post-marketing experience, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data).
Maltese: It-tagħrif ta' hawn taħt jagħti fil-qosor il-frekwenzi tar-reazzjonijiet avversi li ġew irreġistrati wara t-tilqim matul provi kliniċi u minn esperjenza ta' wara t-tqegħid fis-suq, bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data
English: Date of first authorisation: 24 February 2009 Date of latest renewal: 24 February 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 24 ta' Frar 2009 Data tal-aħħar tiġdid: 24 ta' Frar 2014
English: Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France For any information about this medicine, please contact the local representative of the Marketing
Maltese: Val-de-Reuil - Franza Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - Franza
English: INTANZA 15 µg/strain 2017/2018 Influenza vaccine
Maltese: INTANZA 15 µg/razza 2017/2018 Vaċċini ta' kontra l-influwenza, Kodiċi Vaċċin:
English: 1 pre-filled syringe (0.1 ml) with a Micro-Injection System 10 pre-filled syringes (0.1 ml) with a Micro-Injection System 20 pre-filled syringes (0.1 ml) with a Micro-Injection System
Maltese: 1 siringa mimlija għal-lest (0.1 ml) b'Sistema ta' Mikro-Injezzjoni 10 siringi mimlijin għal-lest (0.1 ml) b'Sistema ta' Mikro-Injezzjoni 20 siringa mimlija għal-lest (0.1 ml) b'Sistema ta' Mikro-Injezzjoni
English: INTANZA is a vaccine.
Maltese: INTANZA huwa vaċċin.
English: In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of INTANZA by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
Maltese: III, 398 individwu ta' aktar minn 65 sena rċivew 0.1 ml ta' INTANZA mir-rotta intradermali, u 397 individwu ta' aktar minn 65 sena rċivew 0.5 ml ta' tilqima tal-influwenza trivalenti inattivata u adjuvanti (li fiha MF-59) fl-istess dożaġġ mogħti mir-rotta intramuskolari.
English: Intradermal 15µg A/H3N2
Maltese: Intradermali 15µg
English: • Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Maltese: • Kwalunkwe komponent li jista' jkun preżenti f'ammonti żgħar ħafna bħall-bajd (ovalbumina, proteini tat-tiġieġ), neomycin, formaldehyde u octoxinol 9.
English: Precautions to be taken before handling or administering the medicinal product For instructions on preparation of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq il-preparazzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.