FrancophonIA/ELRC3.0 huggingface dataset:
English: Acne affects more than 50% of teenagers but frequently continues into adulthood.
Maltese: L-akne taffettwa aktar minn 50% taż-żgħażagħ iżda spiss tkompli fl-età adulta.
English: Moreover, women who started OC use before age 20 had a higher risk of breast cancer than those starting later, RR = 1.22 (95 % confidence interval 1.17-1.26; Lancet 1996).
Maltese: Barra minn hekk, in-nisa li bdew jużaw kontraċettiv orali qabel l-età ta' 20 kienu f'riskju akbar ta' kanċer tas-sider minn dawk li bdewh aktar tard, RR = 1.22 (95 % intervall ta' kunfidenza 1.17-1.26; Lancet 1996).
English: The efficacy results in the treatment of moderate acne derive from two placebo-controlled studies which are included in section 5.1 “Pharmacodynamic data” of the SmPC.
Maltese: Ir-riżultati tal-effikaċja fil-kura tal-akne moderata ġejjin minn żewġ studji kkontrollati bi plaċebo li huma inklużi fis-sezzjoni 5.1 “Dejta Farmakodinamika” tal-SmPC.
English: Overall summary of the scientific evaluation of Ethinylestradiol-Drospirenone 24+4 and associated names (see annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Ethinylestradiol-Drospirenone 24+4 u ismijiet assoċjati (ara Anness I)
English: In addition, a higher percentage of subjects, 11.8% (18.6% versus 6.8%), showed a ‘clear' or ‘almost clear' rating on the Investigator's Static Global Assessment (ISGA) scale.
Maltese: Barra minn hekk, perċentwal ogħla ta' suġġetti, 11.8% (18.6% kontra 6.8%), kellhom grad ta' ‘ħielsa' jew ‘kważi ħielsa' fuq l-iskala tal-Valutazzjoni Globali
English: With regard to breast cancer risk, published data showed that the current use of combined OCs is associated with a relative risk (RR) of 1.24 (95 % confidence interval 1.15-1.33).
Maltese: Rigward ir-riskju ta' kanċer tas-sider, id-dejta ppubblikata uriet li l-użu attwali ta' kontraċettivi orali ikkombinati huwa assoċjat ma' riskju relattiv (RR) ta' 1.24 (95 % intervall ta' kunfidenza 1.15-1.33).
English: The safety profile of EE/DRSP - COCs in the approved indication is well known.
Maltese: Il-profil ta' sigurtà ta' kontraċettivi orali kkombinati li fihom EE/DRSP fl-indikazzjoni approvata huwa magħruf sew.
English: With regard to breast cancer risk, the largest meta-analysis to date, including 53297 women with breast cancer and 100239 controls, showed that current use of combined OCs was associated with a relative risk (RR) of 1.24 (95 % confidence interval 1.15-1.33).
Maltese: Rigward ir-riskju ta' kanċer tas-sider, l-akbar meta-analiżi s'issa, li kienet tinkludi 53297 mara b'kanċer tas-sider u 100239 kontroll, uriet li l-użu attwali ta' kontraċettivi orali kkombinati kien assoċjat ma' riskju relattiv (RR) ta' 1.24 (95 % intervall ta' kunfidenza 1.15-1.33).
English: Moreover, when data were analysed by age at first use, women who started OC use before age 20 had a higher risk of breast cancer than those starting later, RR = 1.22 (95 % confidence interval 1.17-1.26; Lancet 1996).
Maltese: Barra minn hekk, meta d-dejta kienet analizzata skont l-età li fiha ttieħed il-kontraċettiv għall-ewwel darba, in-nisa li bdew ilkontraċezzjoni orali qabel l-età ta' 20 sena kienu f'riskju akbar li jkollhom kanċer tas-sider minn dawk li bdewha aktar tard, RR = 1.22 (95 % intervall ta' kunfidenza 1.17-1.26; Lancet 1996).
English: • The Committee noted the overall efficacy of EE/DRSP as a treatment for moderate acne vulgaris in reproductive age women was shown in two placebo-controlled studies.
Maltese: • Il-Kumitat innota li l-effikaċja globali ta' EE/DRSP bħala kura għall-akne vulgaris moderata f'nisa ta' età riproduttiva intweriet f'żewġ studji kkontrollati bi plaċebo.
English: The most serious risks associated with its treatment are venous thromboembolic events (VTEs) and breast cancer:
Maltese: L-aktar riskji serji assoċjati mal-kura tagħha huma effetti tromboemboliċi fil-vini (VTEs) u kanċer tas-sider:
English: In support of this indication, two (A25083 and A25152) multicenter, double blind, randomised, placebo controlled studies were performed to evaluate the efficacy and safety of EE/DRSP in women with moderate acne vulgaris.
Maltese: B'appoġġ għal din l-indikazzjoni, saru żewġ studji fortuwiti (A25083 u A25152), ikkontrollati bi plaċebo, mingħajr l-għarfien taż-żewġ naħat f'diversi ċentri sabiex tiġi evalwata l-effikaċja u s-sigurtà ta' EE/DRSP f'nisa b'akne vulgaris moderata.
English: This treatment does not exempt patients from specific acne treatment if necessary.” in section 4.1 “Therapeutic Indications” of the Summary of Product Characteristics (SmPC).
Maltese: Din il-kura ma teżentax lill-pazjenti minn trattament speċifiku għall-akne jekk ikun meħtieġ.” fis-sezzjoni 4.1 “Indikazzjonijiet terapewtiċi” tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC).
English: Overall benefit-risk assessment
Maltese: Miżuri għall-Imminimizzar tar-Riskju
English: The CHMP considered the MAH proposed measures for risk minimisation not sufficient to ensure the safe and effective use of EE/DRSP in the specific applied clinical situation.
Maltese: Dawn ma tqisux suffiċjenti sabiex jassiguraw l-użu sigur u effettiv ta' EE/DRSP fis-sitwazzjoni klinika speċifika.
English: Statistically significant responses to treatment with EE/DRSP as compared to placebo was seen in all four primary efficacy variables (inflammatory lesion, non-inflammatory lesion, and total lesion counts, and women with a ‘clear' or ‘almost clear' rating on the ISGA scale).
Maltese: Dehru reazzjonijiet statistikament sinifikanti għall-kura b'EE/DRSP meta mqabbel mal-plaċebo f'kull wieħed mill-erba' varjabbli ewlenin tal-effikaċja (feriti infjammati, feriti mhux infjammati, u għadd totali ta' feriti, u nisa bi grad ta' ‘ħielsa' jew ‘kważi ħielsa' fuq l-iskala ISGA).
English: • The Committee found merit on the concerns raised by the Member States regarding the continuation of use of EE/DRSP in the treatment of moderate acne when contraception is no longer needed for which the benefit/risk balance is not acceptable considering the risk of rare but serious adverse events balanced against the limited clinical benefits.
Maltese: • Il-Kumitat sab mertu fit-tħassib imqajjem mill-Istati Membri rigward il-kontinwazzjoni tal-użu ta' EE/DRSP fil-kura ta' akne moderata meta l-kontraċezzjoni ma tibqax meħtieġa li għaliha lbilanċ tar-rapport benefiċċju/riskju m'huwiex aċċettabbli meta wieħed iqis ir-riskju ta' effetti ħżiena rari iżda serji mqabbla mal-benefiċċji kliniċi limitati.
English: The VTE associated risk is higher for EE/DRSP oral contraceptives when compared to other combined oral contraceptives.
Maltese: Ir-riskju assoċjat ta' VTE huwa ogħla għall-kontraċettivi orali li fihom EE/DRSP meta mqabbla ma' kontraċettivi orali oħrajn ikkombinati.
English: The safety profile of the EE/DRSP is known from its use as oral contraception.
Maltese: Il-profil ta' sigurtà ta' EE/DRSP huwa magħruf mill-użu tiegħu bħala kontraċezzjoni orali.
English: The CHMP recognised the efficacy in the overall lesion count reduction.
Maltese: Is-CHMP irrikonoxxa leffikaċja fit-tnaqqis globali tal-għadd ta' feriti.
English: The social, psychological, and emotional impairment that can result from acne has been reported to be similar to that associated with epilepsy, asthma, diabetes, and arthritis.
Maltese: Il-ħsara soċjali, psikoloġika u emozzjonali li tista' toħloq l-akne ġiet irrappurtata li hija simili għal dik assoċjata mal-epilessija, l-ażżma, id-dijabete u l-artrite.
English: With the submission of the responses to the CHMP list of questions, the MAH changed the request for the indication and reverted to the indication as follows: “Treatment of moderate acne vulgaris only in women seeking oral contraception”.
Maltese: Flimkien mas-sottomissjoni tat-tweġibiet għal-lista ta' mistoqsijiet tas-CHMP, il-MAH bidel it-talba rigward l-indikazzjoni u reġa' lura għall-indikazzjoni kif ġej: “Kura ta' akne vulgaris moderata għal dawk in-nisa biss li qegħdin ifittxu kontraċezzjoni orali”.
English: Overall, the safety profile of EE/DRSP oral contraceptives is known and associated with serious adverse events (i.e. VTE and breast cancer).
Maltese: Inġenerali, il-profil ta' sigurtà tal-kontraċettivi orali li fihom EE/DRSP huwa magħruf u assoċjat ma' effetti ħżiena serji (jiġifieri VTE u kanċer tas-sider).
English: This is an important factor when prescribing an oral contraceptive and may preclude EE/DRSP-COCs to be regarded as a first choice for contraception, in clinical practice.
Maltese: Dan huwa fattur importanti meta wieħed jippreskrivi kontraċettiv orali u jista' jipprekludi li kontraċettivi orali kkombinati li fihom EE/DRSP jitqiesu bħala l-ewwel għażla ta' kontraċezzjoni, fil-prattika klinika.
English: The CHMP was requested to give its opinion on whether the overall risk-benefit profile for Ethinylestradiol-Drospirenone 24+4 in the proposed indication was considered acceptable, particularly in light of the known greater risk of venous thromboembolic events (VTE) for DRSP-COCs in comparison with levonorgestrel (LNG)COCs, and initiated the procedure in July 2011.
Maltese: Is-CHMP intalab jagħti l-opinjoni tiegħu dwar jekk il-profil ġenerali tar-riskji u l-benefiċċji għal Ethinylestradiol-Drospirenone 24+4 flindikazzjoni proposta kienx jitqies aċċettabbli, b'mod partikolari meta huwa magħruf ir-riskju akbar ta' effetti tromboemoliċi fil-vini (venous thromboembolic events - VTE) għal kontraċettivi orali kkombinati li fihom DRSP meta mqabbla ma' kontraċettivi orali kkombinati li fihom levonorgestrel (LNG), u beda lproċedura f'Lulju 2011.
English: With regard to the VTE risk associated with EE/DRSP-COCs, the EURAS study (European led study) could not exclude a small difference in VTE risk between drospirenone and other combined OCs.
Maltese: Rigward ir-riskju ta' VTE assoċjat ma' kontraċettivi orali kkombinati li fihom EE/DRSP, l-istudju EURAS (studju mmexxi mill-Ewropa) ma setax jeskludi differenza żgħira fir-riskju ta' VTE bejn drospirenone u kontraċettivi orali ikkombinati oħrajn.
English: The MAH submitted a risk minimisation program to ensure the safe use of EE/DRSP COCs and to limit possible off-label use following authorisation of the applied indication.
Maltese: Il-MAH ippreżenta programm għall-imminimizzar tar-riskju sabiex jassigura l-użu sigur ta' kontraċettivi orali kkombinati li fihom EE/DRSP u sabiex inaqqas il-possibbiltà tal-użu bla tikketta wara lawtorizzazzjoni tal-indikazzjoni li għaliha saret l-applikazzjoni.
English: General tools (e.g. lectures, conferences, symposia) targeting health care providers were proposed as educational material for prescribers by emphasising on the benefit/risk of EE/DRSP use in targeted population and discourage off-label use as well as to highlight to the patients that treatment of moderate acne with EE/DRSP is limited to patients who indeed require hormonal contraception.
Maltese: Ġew proposti għodod ġenerali (eż. lekċers, konferenzi, simpożji) immirati għal dawk li jipprovdu l-kura tas-saħħa bħala materjal edukattiv għal dawk li jippreskrivu billi jenfasizzaw il-benefiċċji u r-riskji tal-użu ta' EE/DRSP fil-popolazzjoni filmira u jiskoraġġixxu l-użu mingħajr tikketta kif ukoll jisħqu mal-pazjenti li l-kura tal-akne moderata b'EE/DRSP hija limitata għal pazjenti li verament jeħtieġu kontraċezzjoni ormonali.
English: The most recent review by the Pharmacovigilance Working Party (PhVWP) concluded in January 2012, confirmed that DRSP-containing OCs are associated with a higher VTE risk than levonorgestrel-containing COCs and that the risk may be similar to that for desogestrel/gestodenecontaining COCs.
Maltese: L-aktar analiżi reċenti mill-Grupp ta' Ħidma tal-Farmakoviġilanza (PhVWP) li ntemmet f'Jannar 2012, ikkonfermat li l-kontraċettivi orali li fihom DRSP huma assoċjati ma' riskju akbar ta' VTE minn kontraċettivi orali kkombinati li fihom levonorgestrel u li r-riskju jista' jkun simili għal dak talkontraċettivi orali kkombinati li fihom desogestrel/gestodene.
English: Consequently, the CHMP concluded in accordance with Article 32 (4) of Directive 2001/83/EC that the variation application does not satisfy the criteria for authorisation and recommends the refusal of the variation to the terms of the Marketing Authorisation for Ethinylestradiol-Drospirenone 24+4 and associated names (see Annex I).
Maltese: Għaldaqstant, is-CHMP ikkonkluda f'konformità mal-Artikolu 32 (4) tad-Direttiva 2001/83/KE li lapplikazzjoni għall-varjazzjoni ma tissodisfax il-kriterji għall-awtorizzazzjoni u jirrakkomanda r-rifjut tal-varjazzjoni għat-termini tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għal EthinylestradiolDrospirenone 24+4 u ismijiet assoċjati (ara Anness I).
English: • The Committee considered the procedure under Article 6(12) of Commission Regulation (EC) no 1084/2003, for Ethinylestradiol-Drospirenone 24+4 and associated names initiated by Italy and Sweden.
Maltese: • Il-Kumitat ikkunsidra l-proċedura taħt l-Artikolu 6(12) tar-Regolament tal-Kunsill (KE) Nru 1084/2003, għal Ethinylestradiol-Drospirenone 24+4 u ismijiet assoċjati mibdija mill-Italja u mill-Isvezja.
English: Considering all the above and the fact that acne is a very common condition in young women, the Committee raised concerns that a beneficial effect noted by the patient from use of EE/DRSP would reduce the motivation to stop the intake when the need for contraception ceases and, therefore, it would not be possible to ensure that the use of the medicinal product would be limited to the treatment of moderate acne vulgaris only in women seeking oral contraception.
Maltese: Meta wieħed iqis dan kollu u l-fatt li l-akne hija kundizzjoni komuni ħafna f'nisa ta' età żgħira, ilKumitat wera dubju dwar jekk l-effett benefiku nnutat minn pazjenta mill-użu ta' EE/DRSP inaqqasx ilmotivazzjoni li tieqaf tużah meta ma jkunx meħtieġ aktar u, għalhekk, ma jkunx possibbli li jiġi żgurat li l-użu tal-prodott mediċinali jkun limitat għall-kura ta' akne vulgaris moderata f'dawk in-nisa biss li jkunu jixtiequ kontraċezzjoni orali.
English: This was corroborated by case-control studies that showed consistent results with a 2 to 3-fold greater risk for drospirenone versus LNGcontaining OCs.
Maltese: Dan kien ikkorroborat minn studji kkontrollati minn każijiet li urew riżultati konsistenti b'riskju darbtejn sa tliet darbiet akbar għal kontraċettivi orali li fihom drospirenone meta mqabbla ma' dawk li fihom LNG.
English: ¾ The specific indication approved.
Maltese: L-indikazzjoni speċifika approvata.
English: Daliresp is contraindicated in patients with moderate or severe liver impairment (Child Pugh B or C).
Maltese: Daliresp hu kontraindikat f'pazjenti b'indeboliment moderat jew sever tal-fwied (Child Pugh B jew Ċ).
English: ¾ The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daliresp should not be initiated or should be stopped in these patients.
Maltese: In-nuqqas ta' esperjenza f'pazjenti b'infezzjoni bl-HIV jew epatite attiva, b'mard immunoloġiku sever (eż. sklerosi multipla, lupus eritematuż, lewkoenċefalopatija multifokali) jew li jkunu kkurati b'terapija immunosoppressiva (minbarra kortikosterojdi sistemiċi għal żmien qasir) u li Daliresp m'għandux jinbeda jew għandu jitwaqqaf f'dawn il-pazjenti.
English: ¾ That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females o Patients concomitantly treated with CYP1A2 inhibitors (such as fluvoxamine) or dual CYP3A4/1A2 inhibitors (such as enoxacin and cimetidine)
Maltese: ○ Popolazzjonijiet speċjali li għandhom żieda fl-inibizzjoni għal PDE4 bħal nisa suwed li ma jpejpux ○ Azjenti kkurati fl-istess ħin b'inibituri ta' CYP1A2 (bħal fluvoxamine) jew b'inibituri doppji ta' CYP3A4/1A2 (bħal enoxacin u cimetidine)
English: ¾ The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Maltese: Ir-riskju potenzjali ta' tumuri malinni u n-nuqqas ta' esperjenza f'pazjenti bi storja medika ta' kanċer.
English: ¾ The limited or missing information in patients with liver impairment.
Maltese: L-informazzjoni limitata jew nieqsa f'pazjenti b'indeboliment tal-fwied.
English: ¾ The potential cardiac risk: Daliresp has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Maltese: Daliresp ma ġiex studjat f'pazjenti b'insuffiċjenza konġestiva talqalb (NYHA grad 3 u 4); għaldaqstant, mhuwiex rakkomandat f'din il-popolazzjoni.
English: ¾ The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
Maltese: In-nuqqas ta' dejta klinika li tissapportja l-kumbinazzjoni ma' theophylline u li kumbinazzjoni bħal din mhijiex rakkomandata.
English: • Summary of Product Characteristics and Patient Information Leaflet for Daliresp
Maltese: Il-pakkett edukattiv għandu jinkludi dawn li ġejjin:
English: The fact that Daliresp is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
Maltese: Il-fatt li Daliresp mhuwiex indikat għall-kura ta' pazjenti b'COPD, ħlief dawk koperti mill-indikazzjoni approvata, u lanqas għall-użu f'pazjenti b'ażżma jew defiċjenza ta' alpha 1 anti trypsine.
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Daliresp are provided with an Educational pack.
Maltese: • Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiżgura li, fit-tnedija talprodott, il-Professjonisti fil-Qasam tal-Kura tas-Saħħa li huma mistennija li jagħtu riċetta għal Daliresp, jingħataw il-Pakkett edukattiv.
English: EMA/CHMP/670965/2010 EMEA/H/C/002269
Maltese: EMA/CHMP/670965/2010
English: This summary was last updated in 10-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2010.
English: In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
Maltese: Fl-ewwel studju, 21 jum wara t-tieni injezzjoni, madwar 90% tal-persuni ta‘ taħt is-60 sena u madwar 80% ta' dawk ta' 'l fuq mis-60 sena kellhom livelli ta' antikopri li jistgħu jipproteġuhom kontra l-H5N1.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains a flu strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14).
Maltese: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics fih razza A/Vietnam/1194/2004 (H5N1)-bħar-razza (NIBRG-14).
English: The full EPAR for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Wieħed jista' jfittex l-EPAR sħiħ għal Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics minn fuq is-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a type of vaccine to be used to protect against a new strain of flu that may cause a future influenza pandemic.
Maltese: Dan huwa tip ta' vaċċin speċjali użat sabiex jipproteġi kontra razza ta' influwenza li tista' tikkawża pandemija fil-futur.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low levels) such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Maltese: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ma għandux jingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill-komponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli ta' traċċi, bħal bajd jew proteina tat-tiġieġ, ovalbumina (proteina fl-abjad tal-bajd), kanamycin jew neomycin sulphate (antibijotiċi), formaldehyde u cetyltrimethylammonium bromide.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults to protect against flu caused by the H5N1 (“bird flu”) strain of the influenza A virus.
Maltese: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics huwa vaċċin għall-użu fl-adulti sabiex jiġu protetti kontra r-razza ta' infuwenza li hija kkawżata mir-razza tal-‘bird flu' H5N1 tal-vajrus tal-influwenza A.
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Maltese: Skont il-kriterji stabbiliti mis-CHMP, vaċċin prepandemiku jeħtieġ li joħloq livelli ta' protezzjoni ta' antikorpi f'mhux inqas minn 70 % tal-persuni biex jitqies adatt.
English: The most common side effects with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni bi Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, mijalġija (uġigħ fil-muskoli), reazzjonijiet fil-punt tal-injezzjoni fosthom uġigħ, ħmura u nefħa, u għeja.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a ‘prepandemic' vaccine.
Maltese: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics huwa vaċċin 'prepandemiku'.
English: The CHMP noted that it is likely that a H5N1 strain of the influenza will cause a pandemic in the future.
Maltese: Is-CHMP innota li jista' jkun li r-razza tal-infuwenza tista' tikkawża pandemija fil-futur.
English: Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.
Maltese: L-esperti tas-saħħa huma mħassba dwar il-fatt li linfluwenza pandemika fil-futur tista' tiġi kkawżata mir-razza H5N1 tal-vajrus.
English: In the second study involving 240 people, subjects were given Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics using different vaccination schedules.
Maltese: Fit-tieni studju li nvovla 240 persuna, is-suġġetti ġew mogħtija Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics bl-użu ta' skedi ta' vaċċinazzjoni differenti.
English: This vaccine contains some parts of the H5N1 virus.
Maltese: Dan il-vaċċin fih xi partijiet tal-vajrus H5N1.
English: The applicant presented data on experimental models with vaccines similar to Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Maltese: L-applikant ippreżenta dejta dwar mudelli sperimentali b'vaċċini simili għal Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: Other information about Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Maltese: Informazzjoni ulterjuri dwar Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics