FrancophonIA/ELRC3.0 huggingface dataset:
English: Across all three influenza strains, for the egg-derived vaccine seroprotection rates ranged between 85% and 98%, seroconversion or significant increase rates ranged between 62% and 73% and GMRs ranged between 5.52- and 8.76-fold over baseline HI titers.
Maltese: Fuq il-firxa tat-tliet razez ta' l-influwenza, għat-tilqima derivata mill-bajd, ir-rati tas-seroprotezzjoni varjaw bejn 85% u 98%, is-serokonverżjoni jew iż-żieda sinifikanti fir-rata varjaw bejn 62% u 73%, u l-GMRs varjaw bejn 5.52 u 8.76 darbiet aktar mit-titers HI tal-linja bażi.
English: Common ≥ 1/100 to
Maltese: Komuni ≥ 1/100 sa < 1/10
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Maltese: Wara t-tilqima tal-influwenza, jistgħu jinkisbu riżultati pożittivi-foloz fit-testijiet seroloġiċi li jużaw il-metodu ELISA għall-antikorpi kontra l-virus-1 tal-immunodefiċjenza umana (HIV-1), il-virus tal-epatite Ċ u speċjalment HTLV-1.
English: 15 micrograms HA** 15 micrograms HA** per 0.5 ml dose
Maltese: 15-il mikrogramma HA** 15-il mikrogramma HA** f'kull doża ta' 0.5 ml
English: - Local lymphadenopathy
Maltese: - Limfadenopatija lokali
English: Vaccine Efficacy* % Lower Limit of OneSided 97.5% CI
Maltese: Effikaċja tat-Tilqima* % Limitu t'Isfel ta' One-Sided 97.5% CI
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 June 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 01 ta' Ġunju 2007
English: The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Maltese: Is-sustanzi l-oħra huma: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għall-injezzjonijiet.
English: - Extensive swelling of injected limb
Maltese: - Nefħa estensiva fiddriegħ/riġel injettat
English: Multipack: 20 (2 packs of 10) pre-filled syringes (0.5 ml) without needle Multipack: 20 (2 packs of 10) pre-filled syringes (0.5 ml) with needle
Maltese: Pakkett multiplu: 20 (2 pakketti ta' 10) siringa mimlija għal-lest (0.5 ml) mingħajr labra Pakkett multiplu: 20 (2 pakketti ta' 10) siringa mimlija għal-lest (0.5 ml) bil-labra
English: * Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks.
Maltese: * Intervalli ta' kunfidenza simultanji one-sided 97.5% għall-effikaċja tat-tilqima ta' kull tilqima kontra l-influwenza meta mqabbla mal-plaċebo bbażat fuq l-intervalli ta' kunfidenza tal-punteġġ ikkoreġut permezz ta' Sidak għaż-żewġ riskji relattivi.
English: Vaccine Efficacy = (1 - Relative Risk) x 100 %; ** There were too few cases of influenza due to vaccine-matched influenza A/H3N2 or B to adequately assess vaccine efficacy.
Maltese: Effikaċja tat-Tilqima = (1 - Riskju Relattiv) x 100% ** Kien hemm ftit wisq każijiet ta' influwenza minħabba influwenza A/H3N2 jew B imqabbla mat-tilqima biex l-effikaċja tat-tilqima tiġi evalwata b'mod adegwat.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optaflu (2015/2016 season)
Maltese: U MNEJN GĦANDU JINGĦATA Optaflu (Staġun 2015/2016)
English: A single syringe contains 0.5 ml of suspension for injection.
Maltese: Siringa waħda fiha 0.5 ml ta' suspensjoni għall-injezzjoni.
English: The following adverse reactions have been observed:
Maltese: Sorveljanza wara t-tqegħid fis-suq:
English: Rare to <1/1000
Maltese: Rari ≥ 1/10,000 sa
English: shivering
Maltese: Treddigħ
English: Uncommon ≥ 1/1000 to
Maltese: Mhux Komuni ≥ 1/1000 sa
English: The incidence rates for moderate and severe pain after Optaflu vaccination are similar to those of egg-derived influenza vaccines; however a slightly increased risk for mild short-lasting injection site pain was observed with Optaflu in the subgroup of elderly vaccinees (8% compared to 6% with egg-derived influenza vaccine).
Maltese: Ir-rati ta' l-inċidenza għal uġigħ moderat u sever wara t-tilqima b'Optaflu huma simili għal dawk ta' tilqim ta' l-influwenza derivat mill-bajd; madankollu, b'Optaflu kienet osservata żieda żgħira fir-riskju għall-uġigħ fis-sit ta' l-injezzjoni li jkun ħafif u li jdum ftit, fis-sotto-grupp ta' pazjenti anzjani li ngħataw it-tilqima (8% mqabbla ma' 6% bit-tilqima ta' l-influwenza derivata mill-bajd).
English: Overall 7253 single doses of Optaflu were administered to 6180 adults aged 18 - 60 years of age and to 1073 elderly (aged 61 years or older).
Maltese: B'kollox, 7253 dożi waħidhom ta' Optaflu ngħataw lil 6180 pazjent adult li kellhom 18 - 60 sena u 1073 pazjent anzjan (li kellhom 61 sena jew iktar).
English: The immunological response may be diminished if the patient is undergoing immunosuppressant
Maltese: Ir-respons immunoloġiku jista' jitnaqqas jekk il-pazjent ikun qed jieħu kura immunosuppressanti.
English: Optaflu is a vaccine against flu (influenza).
Maltese: Optaflu hu tilqima kontra l-influwenza.
English: 15 micrograms HA** per 0.5 ml dose
Maltese: 15-il mikrogramma HA** f'kull doża ta' 0.5 ml
English: The vaccine targets three strains of influenza virus following the recommendations by the World Health Organisation for the 2015/2016 season.
Maltese: It-tilqima għandha fil-mira tagħha tliet razez tal-virus tal-influwenza wara r-rakkomandazzjonijiet mill-Organizzazzjoni Dinjija tas-Saħħa għall-istaġun 2015/2016.
English: One dose of 0.5 ml
Maltese: Doża waħda ta' 0.5 ml
English: A total of 11,404 subjects were enrolled to receive Optaflu (N=3828), Agrippal (N=3676) or placebo (N=3900) in a 1:1:1 ratio.
Maltese: Total ta' 11,404 individwu ġew irreġistrati biex jirċievu Optaflu (N=3828), Agrippal (N=3676) jew plaċebo (N=3900) fi proporzjon ta' 1:1:1. Fost il-popolazzjoni globali tal-istudju li ġiet irreġistrata, l-età medja kienet ta' 33 sena, 55% kienu nisa, 84% kienu Kawkasi, 7% kienu Suwed, 7% kienu Ispaniċi, u 2% kienu ta' oriġini etnika oħra.
English: Common (affects 1 to 10 users in 100):
Maltese: Komuni (jaffetwaw minn 1 sa 10 utenti minn kull 100):
English: Optaflu was well tolerated and immunogenic in mice and ferrets.
Maltese: Optaflu kien ittollerat tajjeb u kien immunoġeniku fil-ġrieden u fl-inmsa.
English: - Thrombocytopenia**
Maltese: - Trombocitopenija**
English: Pack sizes of 1, 10 or multipacks containing 20 (2 packs of 10) pre-filled syringes, each with or
Maltese: Pakketti tad-daqsijiet ta' 1, 10 jew pakketti multipli li jkun fihom 20 (2 pakketti ta' 10) siringi mimlija għal-lest, kull siringa bil-labra jew mingħajrha.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK - Inner Carton Box for 10 pre-filled syringes with needles - Inner Carton Box for 10 pre-filled syringes without needles Inner carton box will not include “Blue Box”.
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA PAKKETT MULTIPLU - Kaxxa tal-Kartun ta' Ġewwa għal 10 siringi mimlija għal-lest bil-labar - Kaxxa tal-Kartun ta' Ġewwa għal 10 siringi mimlija għal-lest bla labar Il-kaxxa tal-kartun ta' ġewwa mhux se tkun tinkludi “Blue Box”.
English: Rare (affects 1 to 10 users in 10,000):
Maltese: Rari (jaffetwaw minn 1 sa 10 utenti minn kull 10,000):
English: ILI was defined according to Centers for Disease Control and Prevention (CDC) case definition, i.e., a fever (oral temperature ≥ 100.0°F / 38°C) and cough or sore throat.
Maltese: ILI ġie definit skont id-definizzjoni tal-każ tas-Centers for Disease Control and Prevention (CDC), jiġifieri, deni (temperatura orali ta' ≥ 100.
English: • gastrointestinal disorders such as abdominal pain, diarrhoea or disturbance of the digestive tract These reactions are usually mild and only last a few days.
Maltese: • disturbi gastro-intestinali bħal uġigħ ta' żaqq, dijarea jew disturbi fl-apparat diġestiv Dawn ir-reazzjonijiet normalment ikunu ħfief u jdumu biss ftit jiem.
English: Reporting of suspected adverse reactions after authorisation of the medicinal products is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Optaflu contains sodium chloride and potassium chloride This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Optaflu fih sodium chloride u potassium chloride Din it-tilqima fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħielsa
English: This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free'.
Maltese: Din it-tilqima fiha anqas minn 1 mmol (39 mg) ta' potassium f'kull doża, jiġifieri essenzjalment
English: The following side effects have been observed during clinical trials and post-marketing surveillance:
Maltese: L-effetti sekondarji li ġejjin kienu osservati waqt il-provi kliniċi u waqt is-sorveljanza wara t-tqegħid fis-suq:
English: • flu-like symptoms such as headache, feeling of discomfort, tiredness, muscle pain.
Maltese: • sintomi bħal ta' l-influwenza bħal uġigħ ta' ras, sensazzjoni ta' skonfort, għeja, uġigħ fil-muskoli
English: ** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥40; significant increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer.
Maltese: ** Serokonverżjoni = titer HI negattiv qabel it-tilqima u titer HI pożittiv wara t-tilqima ≥ 40, żieda sinifikanti = titer HI ta' qabel it-tilqima pożittiv u żieda mill-anqas 4 darbiet aktar fit-titer HI ta' wara t-tilqima.
English: Due to the kind of manufacturing Optaflu is free of When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Maltese: Meta persuna tingħata t-tilqima, is-sistema immuni (is-sistema ta' difiża naturali tal-ġisem) tipproduċi l-protezzjoni tagħha stess kontra l-virus tal-influwenza.
English: INSTRUCTIONS ON USE
Maltese: U INDIRIZZ TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following
Maltese: U KWANTITATTIVA Antiġeni tal-wiċċ tal-virus ta' l-influwenza (haemagglutinin u neuraminidase)*, inattivati, tar-razez
English: - Neurological disorders, such as Guillain Barré syndrome, encephalomyelitis and neuritis
Maltese: - Disturbi newroloġiċi, bħassindromu ta' Guillain Barré, enċefalomajelite u newrite
English: In this comparative trial against an egg-derived influenza vaccine the seroprotection* rate, seroconversion or significant increase rate** and the geometric mean ratio (GMR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
Maltese: F'din il-prova komparattiva kontra tilqima ta' l-influwenza derivata mill-bajd, ir-rata tas-seroprotezzjoni*, is-serokonverżjoni jew ir-rata taż-żieda sinifikanti** u l-proporzjon medju ġeometriku (GMR) għall-antikorp anti-HA (imkejjel minn HI) kienu evalwati skond kriterji definiti
English: The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
Maltese: Is-sustanzi attivi huma antiġeni tal-wiċċ tal-virus ta' l-influwenza (haemagglutinin u neuraminidase)*, inattivati, tar-razez li ġejjin:
English: Seroconversion/Significant increase rate
Maltese: Rata ta' seroprotezzjoni Serokonverżjoni/żieda sinifikanti fir-rata
English: 1 pre-filled syringe (0.5 ml) with needle 10 pre-filled syringes (0.5 ml) with needle 1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle
Maltese: siringa 1 mimlija għal-lest (0.5 ml) bil-labra 10 siringi mimlijin għal-lest (0.5 ml) bil-labra siringa 1 mimlija għal-lest (0.5 ml) mingħajr labra 10 siringi mimlijin għal-lest (0.5 ml) mingħajr labra
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Maltese: Dan jista' jiġri flimkien ma' diversi sinjali newroloġiċi bħal disturb temporanju fil-vista, parasteżija u ċaqliq toniku-kloniku tal-idejn jew tar-riġlejn waqt il-fejqan.
English: 0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber).
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Suspensjoni ta' 0.5 ml f'siringi mimlija għal-lest (ħġieġ ta' tip I) b'tapp bil-planġer (lastku bromobutyl).
English: Prophylaxis of influenza for adults, especially in those who run an increased risk of associated
Maltese: Profilassi ta' l-influwenza għall-adulti, speċjalment f'dawk li jkollhom riskju akbar ta'
English: Data for adults were as follows (values in brackets show the 95% confidence intervals):
Maltese: L-informazzjoni għall-adulti kienet kif ġej (il-figuri fil-parentesi juru l-intervalli tal-kunfidenza 95%):
English: Optaflu is used to prevent flu in adults, especially in those who run an increased risk of experiencing associated complications in case they fall ill with flu.
Maltese: Optaflu jintuża għall-prevenzjoni ta' l-influwenza fl-adulti, speċjalment f'dawk li jkollhom riskju akbar ta' komplikazzjonijiet assoċjati f'każ li jimirdu bl-influwenza.
English: Seroprotection is generally obtained within 3 weeks, as shown by the pivotal phase III clinical study V58P4 for the adult and elderly population.
Maltese: Is-seroprotezzjoni ġeneralment tinkiseb fi żmien 3 ġimgħat, kif wera l-istudju kliniku V58P4 importanti ħafna ta' fażi
English: Optaflu has not been studied in the paediatric population and therefore, data on immune response are not available for this age group.
Maltese: Optaflu ma kienx studjat fil-popolazzjoni pedjatrika u għalhekk, l-informazzjoni fuq ir-respons immuni mhix disponibbli għal dan il-grupp ta' età.
English: Therefore, Optaflu is not recommended for use in children and adolescents less than 18 years of age (see section 5.1).
Maltese: Għalhekk, Optaflu mhuwiex rakkomandat għall-użu fit-tfal u fl-adoloxxenti li għandhom inqas minn 18-il sena (ara sezzjoni 5.1).
English: Table 3: Comparative Efficacy of Optaflu versus Placebo against Culture-Confirmed
Maltese: Tabella 3: Effikaċja Komparattiva ta' Optaflu kontra Plaċebo kontra Influwenza Kkonfermata mill-Koltura skont is-Sottotip Virali tal-Influwenza
English: • weakness beginning in the legs and progressing to the arms with numbness and tingling sensation which are symptoms of an inflammation of the nerves
Maltese: • dgħjufija li tibda fir-riġlejn u tinfirex lejn id-dirgħajn bi tnemnim u b'sensazzjoni ta' tingiż li huma sintomi ta' infjammazzjoni tan-nervituri
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe
English: Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Maltese: Optaflu suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Tilqima ta' l-influwenza (antiġen tal-wiċċ, inattivata, ippreparata f'kulturi taċ-ċelluli)
English: It should be noted that adverse reactions may be intensified.
Maltese: Wieħed għandu jkun jaf li r-reazzjonijiet avversi jistgħu jintensifikaw.
English: No effects on the breastfed newborn /infant are anticipated.
Maltese: S'issa l-esperjenza ta' wara t-tqegħid fis-suq hija limitata b'Optaflu.
English: The safety of Optaflu has been assessed in seven randomized, active controlled clinical trials performed as part of the development program.
Maltese: Is-sigurtà ta' Optaflu kienet evalwata f'seba' provi kliniċi randomized, ikkontrollati b'mod attiv li twettqu bħala parti mill-programm ta' l-iżvilupp.
English: Other medicines and Optaflu
Maltese: Mediċini oħra u Optaflu
English: Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02
Maltese: Tilqima ta' l-influwenza, Kodiċi ATC:
English: Reporting of suspected adverse reactions:
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: The safety of Optaflu in pregnancy and breast-feeding has not been assessed in clinical trials.
Maltese: Is-sigurtà ta' Optaflu fit-tqala u t-treddigħ ma kinitx evalwata fil-provi kliniċi.
English: In the elderly frequencies were similar, except for myalgia, headache and injection site pain which were classified as ‘common'.
Maltese: Fl-anzjani, il-frekwenzi kienu simili, minbarra l-mijalġja, l-uġigħ ta' ras u uġigħ fis-sit tal-injezzjoni li kienu kklassifikati bħala ‘komuni'.
English: • difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)
Maltese: • diffikultà biex tieħu n-nifs, sturdament, polz dgħajjef u mgħaġġel u raxx tal-ġilda li huma sintomi ta' reazzjoni anafilattika (reazzjoni allerġika severa ħafna)
English: The persistence of postvaccination antibodies to strains included in the vaccine is usually 6-12 months, as shown by studies performed during the clinical development of this vaccine.
Maltese: Il-persistenza ta' l-antikorpi ta' wara t-tilqima għal razez inklużi fit-tilqima normalment iddum sa 6-12-il xahar, kif urew studji li twettqu matul l-l-iżvilupp kliniku ta' din it-tilqima.
English: • sweating, joint pain, chills, hardening or swelling at the site of the injection, bruising, fever,
Maltese: • għaraq, uġigħ fil-ġogi, tertir ta' bard, ebusija jew nefħa fis-sit ta' l-injezzjoni, tbenġil, deni, tertir
English: Note that the side effects of the vaccines may be intensified.
Maltese: Wieħed għandu jkun jaf li l-effetti sekondarji tat-tilqim jistgħu jintensifikaw.
English: Tell the doctor requesting the test that you have recently received Optaflu.
Maltese: Ma ġie rrapportat l-ebda każ ta' doża eċċessiva għal Optaflu.
English: • your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration.
Maltese: • it-tabib jew in-ners tiegħek ser jiżguraw li kura medika u superviżjoni adattata jkunu disponibbli fil-pront f'każ ta' reazzjoni anafilattika rari (reazzjoni allerġika severa ħafna b'sintomi bħal diffikultà biex tieħu n-nifs, sturdament, polz dgħajjef u mgħaġġel u raxx tal-ġilda) wara li tieħu t-tilqima.
English: Animal data have not shown effects on female fertility (see section 5.3).
Maltese: Dejta mill-annimali ma wrietx effetti fuq ilfertilità fin-nisa (ara sezzjoni 5.3). Il-fertilità fl-irġiel ma ġietx evalwata fl-annimali (ara sezzjoni 5.3).
English: In a repeated-dose toxicity study in rabbits there was no evidence of systemic toxicity and the vaccine was locally well tolerated.
Maltese: Fi studju dwar l-effett tossiku minn dożi ripetuti fil-fniek ma kien hemm l-ebda evidenza ta' tossiċità sistemika u t-tilqima kienet ittollerata tajjeb lokalment.
English: The European Medicines Agency has deferred the obligation to submit the results of studies withOptaflu in one or more subsets of the paediatric population in the prevention of influenza (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Optaflu f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-prevenzjoni tal-influwenza (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: BATCH NUMBER Batch:
Maltese: Fuljett ta' tagħrif:
English: ** Thrombocytopenia (some very rare cases were severe with platelet counts less than 5000 per mm3)
Maltese: Rari ħafna (jaffetwaw anqas minn utent 1 minn kull 10,000):
English: Carton Box for syringe(s) with needle - 1 pre-filled syringe (0.5 ml) with needle - 10 pre-filled syringes (0.5 ml) with needle
Maltese: Kaxxa tal-Kartun għal siringa(i) mingħajr labra - siringa waħda mimlija għal-lest (0.5 ml) mingħajr labra - 10 siringi mimlija għal-lest (0.5 ml) mingħajr labra
English: Optaflu is injected into the muscle on the top of the upper arm (deltoid muscle).
Maltese: Optaflu jiġi injettat ġol-muskolu fin-naħa ta' fuq tad-driegħ (ġol-muskolu tad-deltoid).
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Maltese: Sinkope (ħass ħażin), tista' sseħħ wara, jew saħansitra qabel, kwalunkwe tilqima, bħala reazzjoni psikoġenika għall-injezzjoni bil-labra.
English: Healthcare professionols are asked to report any suspected adverse reactions via the national reporting sytem listed in Appendix V.
Maltese: B'mod ġenerali, informazzjoni mit-tilqim ta' l-influwenza f'nisa tqal, ma tindikax riżultati avversi fil-fetu u fl-omm, attribwiti mat-tilqima.
English: Your doctor will decide if you should receive Optaflu.
Maltese: Ta' kulur minn ċar sa ftit opalexxenti.
English: The safety and efficacy of Optaflu in children and adolescents less than 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Optaflu fit-tfal u fl-adoloxxenti li għandhom anqas minn 18-il sena għadhom ma ġewx stabbiliti.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI).
Maltese: Każijiet ta' influwenza ġew identifikati minn sorveljanza attiva u passiva ta' mard li jixbah lill-influwenza (ILI).
English: Efficacy against Culture-Confirmed Influenza
Maltese: Effikaċja kontra Influwenza Kkonfermata mill-Koltura
English: No evidence of reproductive or developmental toxicity was seen in a study where the human dose of Optaflu was administered prior to and during gestatioin to female rabbits.
Maltese: L-ebda evidenza ta' tossiċità riproduttiva jew tal-iżvilupp ma ġiet osservata fi studju fejn id-doża umana ta' Optaflu ingħatat qabel u matul it-tqala lil fniek nisa.
English: Resolor prucalopride
Maltese: Resolor prukalopride
English: The full EPAR for Resolor 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: It is available as tablets (1 and 2 mg).
Maltese: Jiġi bħala pilloli (1 u 2 mg).
English: The active substance in Resolor, prucalopride, is a ‘5-HT4 receptor agonist'.
Maltese: Is-sustanza attiva f'Resolor, il-prukalopride, hija ‘agonist tar-riċettur 5-HT4'.
English: Resolor is a medicine that contains the active substance prucalopride.
Maltese: Resolor huwa mediċina li fiha s-sustanza attiva prukalopride.
English: Over the 12-week period, 24% (151 out of 640) of patients who received Resolor 2 mg completely emptied their bowels at least three times a week, compared with 11% (73 out of 645) of patients who received placebo.
Maltese: Fuq perjodu ta' 12-il ġimgħa, 24% (151 minn 640) tal-pazjenti li ngħataw Resolor 2 mg battlu kompletament imsarinhom tal-inqas tliet darbiet fil-ġimgħa, meta mqabbla ma' 11% (73 minn 645) tal-pazjenti li ngħataw plaċebo.