FrancophonIA/ELRC3.0 huggingface dataset:
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member States shall agree the details of a Patient Alert Card (PAC) with the MAH, who must provide this PAC directly to the pharmacy with each Ranexa shipment.
Maltese: L-Istati Membri għandhom jaqblu fuq id-dettalji tal-Kard ta' Twissija tal-Pazjent (PAC) mad-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq, li għandu jipprovdi dan ilPAC direttament lill-ispiŜerija ma' kull kunsinna ta' Ranexa.
English: • Call their doctor if they feel dizzy or sick, become sick or experience any unexpected symptoms after starting Ranexa.
Maltese: • Isejjaħ lit-tabib tiegħu jekk iħossu stordut, imdardar jew jirremetti jew jesperjenza xi sintomu mhux mistenni wara li jibda Ranexa.
English: Health Care Professional information The PAC should include the following information for the healthcare professional information regarding Ranexa:
Maltese: Il-PAC għandu jinkludi l-informazzjoni li āejja għall-professjonisti tal-kura tas-saħħa fir-rigward ta' Ranexa:
English: • Ranexa is contraindicated in patients taking:
Maltese: • Ranexa mhuwiex rakkomdanat f'pazjenti li qegħdin jieħdu:
English: EU/1/15/1084/001 Portrazza
Maltese: EU/1/15/1084/001
English: 50 ml (16 mg/ml) 1 vial
Maltese: 50 ml (16 mg/ml)
English: 800 mg Concentrate for solution for infusion
Maltese: 800 mg Konċentrat għal soluzzjoni għallinfużjoni
English: This summary was last updated in 04-2012.
Maltese: Is-sommarju ġie aġġornat l-aħħar f'04-2012.
English: The full EPAR for Bronchitol 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: The summary of the opinion of the Committee for Orphan Medicinal Products for Bronchitol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: Bronchitol is a medicine that contains the active substance mannitol.
Maltese: Bronchitol hwaa mediċina li fiha s-sustanza attiva mannitol.
English: This is a summary of the European public assessment report (EPAR) for Bronchitol.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Bronchitol.
English: Other information about Bronchitol
Maltese: Informazzjoni oħra dwar Bronchitol
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bronchitol on 13 April 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Bronchitol fit-13 ta' April 2012.
English: Bronchitol was tested in two main studies involving 642 patients between six and 56 years of age with mild or moderate cystic fibrosis.
Maltese: Bronchitol ġie ttestjat f'żewġ studji ewlenin li involvew 642 pazjent b'etajiet li jvarjaw bejn is-6 u l-56 sena b'fibriżo ċistika ħafifa jew moderata.
English: The active substance in Bronchitol, mannitol, is a naturally occurring polyol (a sugar alcohol) that is widely used as an osmotic agent.
Maltese: Is-sustanza attiva fi Bronchitol, il-mannitol, hija polyol preżenti b'mod naturali (alkoħol zokkri) li tintuża b'mod komuni bħala aġent osmotiku.
English: Some patients also received additional treatment with rhDNase (another treatment for cystic fibrosis).
Maltese: Uħud mill-pazjenti rċivew ukoll trattament addizzjonali b'rhDNase (trattament ieħor għall-fibrożi ċistika).
English: Because the number of patients with cystic fibrosis is low, the disease is considered ‘rare', and Bronchitol was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November
Maltese: Minħabba li n-numru ta' pazjenti li għandhom fibrożi ċistika huwa wieħed baxx, il-marda hija kkunsidrata bħala waħda ‘rari', u Bronchitol ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis-7 ta' Novembru 2005.
English: The most serious side effect with Bronchitol is bronchospasm (narrowing of the airways of the lung) during the initiation dose assessment and haemoptysis (coughing of blood) during treatment with Bronchitol.
Maltese: L-effett sekondarju l-aktar serju bi Bronchitol huwa bronkospażmu (tidjiq tal-passaġġi tal-arja tal-pulmun) matul il-valutazzjoni tad-doża inizjali u emoptisi (sogħla bid-demm) matul it-trattament bi Bronchitol.
English: Why has Bronchitol been approved?
Maltese: Għaliex ġie approvat Bronchitol?
English: Bronchitol must not be used in people who are hypersensitive (allergic) to mannitol.
Maltese: Bronchitol ma jistax jintuża f'nies li huma ipersensittivi (allerġiċi) għal mannitol.
English: In both studies the patients received either 400 mg of inhaled Bronchitol twice daily or 50 mg of inhaled Bronchitol twice daily (which was considered ineffective and hence intended as placebo (dummy treatment)).
Maltese: Fiż-żewġ studji, il-pazjenti rċivew jew 400 mg ta' Bronchitol meħud man-nifs darbtejn kuljum jew 50 mg ta' Bronchitol meħud man-nifs darbtejn kuljum (li tqies ineffettiv u għalhekk, maħsub bħala plaċebo (trattament finta)).
English: What is Bronchitol?
Maltese: X'inhu Bronchitol?
English: It is available as capsules (40 mg) containing a dry powder for inhalation using an inhaler device.
Maltese: Jiġi bħala kapsuli (40 mg) li fihom trab xott u li jittieħdu man-nifs permezz ta' inalatur.
English: What measures are being taken to ensure the safe use of Bronchitol?
Maltese: Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Bronchitol?
English: What is the risk associated with Bronchitol?
Maltese: X'inhu r-riskju assoċjat ma' Bronchitol?
English: The recommended dose is 400 mg (which requires the inhalation of the content of 10 capsules loaded individually into the inhaler) twice a day in the morning and in the evening.
Maltese: Id-doża rakkomandata hija 400 mg (li teħtieġ l-inalazzjoni tal-kontenut ta' 10 kapsuli mdaħħla b'mod individwali fl-inalatur) darbtejn kuljum, filgħodu u filgħaxija.
English: Cystic fibrosis is an inherited disease that affects the cells in the lungs and the glands in the gut and pancreas that secrete fluids such as mucus and digestive juices.
Maltese: Fil-fibrożi ċistika, dawn il-fluwidi jsiru viskużi u akbar filvolum, isoddu l-passaġġi tal-arja u l-fluss tal-meraq diġestiv.
English: The effects of Bronchitol were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Bronchitol ġew ittestjati l-ewwel darba f'mudelli sperimentali qabel ma ġie studjat filbniedem.
English: Patients who show bronchial hyperresponsiveness must not be treated with Bronchitol.
Maltese: Il-pazjenti li juru rispons eċċessiv tal-bronki ma jistgħux jiġu ttrattati bi Bronchitol.
English: Patients overall showed an improvement of approximately 2-3% in FEV1 adjusted for age, height and sex when compared with placebo over 26 weeks of treatment with Bronchitol.
Maltese: B'mod ġenerali, wara 26 ġimgħa ta' trattament b'Bronchitol, il-pazjenti wrew titjib ta' bejn wieħed u ieħor 2-3% fl-FEV1 aġġustat għall-età, it-tul u s-sess meta mqabbel mal-plaċebo.
English: The exact way in which Bronchitol works in cystic fibrosis is not known.
Maltese: Mhuwiex magħruf il-mod eżatt li bih jaħdem Bronchitol fil-fibrożi ċistika.
English: What benefit has Bronchitol shown during the studies?
Maltese: Liema benefiċċju wera Bronchitol waqt l-istudji mwettqa?
English: Before initiating treatment with Bronchitol, patients need to undergo an initiation dose assessment during which they are challenged with an increasing dose of Bronchitol up to 400 mg in total to detect bronchial hyperresponsiveness (a state in which the airways of the lungs narrow easily).
Maltese: Qabel jibdew it-trattament bi Bronchitol, il-pazjenti jridu jiġu sottomessi għal valutazzjoni tad-doża inizjali li matulha jingħataw doża li tiżdied ta' Bronchitol li b'kollox tasal sa 400 mg sabiex jiġi identifikat rispons eċċessiv tal-bronki (qagħda li fiha l-passaġġi tal-arja tal-pulmuni jidjiequ faċilment).
English: For the full list of all side effects reported with Bronchitol, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Bronchitol, ara l-fuljett ta' tagħrif.
English: This first dose of 400 mg Bronchitol should only be given under the supervision of a qualified healthcare professional in a setting where the patient's breathing can be properly monitored and facilities for resuscitation are available.
Maltese: L-ewwel doża ta' 400 mg ta' Bronchitol għandha tingħata biss taħt is-superviżjoni ta' professjonista ikkwalifikat fil-qasam tal-kura tas-saħħa f'kuntest fejn it-teħid tan-nifs tal-pazjent ikun jista' jiġi ssorveljat kif suppost u faċilitajiet għar-risuxxitazzjoni jkunu disponibbli.
English: The CHMP therefore concluded that the benefits of Bronchitol in addition to best standard of care outweigh its risks for adult patients with cystic fibrosis and recommended that it be granted marketing authorisation.
Maltese: Għaldaqstant, is-CHMP ikkonkluda li l-benefiċċji ta' Bronchitol flimkien malaħjar standard ta' kura huma akbar mir-riskji tiegħu għall-pazjenti adulti b'fibrożi ċistika u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Bronchitol been studied?
Maltese: Kif ġie studjat Bronchitol?
English: The main measure of effectiveness was based on the improvement in patients' forced expiratory volume in one second (FEV1) adjusted for the patients age, height and sex, measured over 26 weeks in both studies.
Maltese: Il-kejl ewlieni tal-effikaċja kien ibbażat fuq it-titjib fil-volum espiratorju sfurzat tal-pazjenti f'sekonda (FEV1) aġġustat għall-età, it-tul u s-sess tal-pazjenti, imkejjel fuq 26 ġimgħa fiż-żewġ studji.
English: Bronchitol is used for the treatment of cystic fibrosis in adults in addition to best standard of care.
Maltese: Bronchitol jintuża għat-trattament ta' fibrożi ċistika fl-adulti flimkien mal-aħjar standard ta' kura.
English: The most common side effect with Bronchitol (seen in more than 1 patient in 10) is cough.
Maltese: L-effett sekondarju l-aktar komuni bi Bronchitol (li deher f'aktar minn pazjent 1 minn kull 10) hija ssogħla.
English: The vaccine contains a flu strain called ‘A/Indonesia/05/2005 PR8-IBCDCRG2' (H5N1).
Maltese: Il-vaċċin fih ir-razza tal-influwenza msejħa ‘A/Indonesia/05/2005 PR8-IBCDC-RG2' (H5N1).
English: The full EPAR for Pumarix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Pumarix jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Pumarix is a vaccine to protect against ‘pandemic' flu.
Maltese: Pumarix huwa vaċċin li jipproteġi kontra l-influwenza ‘pandemika'.
English: In the second main study, 4,560 adults were given either Pumarix or placebo (a dummy vaccine).
Maltese: Fit-tieni studju prinċipali, 4,560 adult ingħataw jew Pumarix jew plaċebo (vaċċin finta).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pumarix to GlaxoSmithKline Biologicals s.a. on 4 March 2011.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pumarix lil GlaxoSmithKline Biologicals s.a. fil-4. ta' Marzu 2011.
English: What is Pumarix?
Maltese: Kif jaħdem Pumarix?
English: Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għall-Influwenza Pandemika (H5N1) (virjon maqsum, diżattivat,
English: This is a summary of the European public assessment report (EPAR) for Pumarix.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Pumarix.
English: What information is still awaited for Pumarix?
Maltese: Liema informazzjoni għadha mistennija għal Pumarix?
English: Why has Pumarix been approved?
Maltese: Għaliex ġie approvat Pumarix?
English: This vaccine contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1.
Maltese: Dan il-vaċċin fih ammonti żgħar ta' haemagglutinins (proteini mill-wiċċ) ta' virus imsejjaħ H5N1.
English: One main study involving 680 adults compared Pumarix given as two doses three weeks apart with Pandemrix H5N1 (another pandemic influenza vaccine) and also compared Pumarix given with and without an adjuvant.
Maltese: Studju prinċipali wieħed li kien jinvolvi 680 adult qabbel Pumarix mogħti f'żewġ dożi bi tliet ġimgħat bejniethom ma' Pandemix H5N1 (vaċċin ieħor kontra l-influwenza pandemika) u qabbel ukoll Pumarix mogħti flimkiem ma' adjuvant jew mingħajru.
English: Pumarix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde and sodium deoxycholate.
Maltese: Pumarix m'għandux jingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal kwalunkwe wieħed mill-komponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli ta' traċċi fil-vaċċin, bħal bajd jew proteina tat-tiġieġ, ovalbumina (proteina fl-abjad tal-bajd),
English: The most common side effects with Pumarix (seen in more than 1 patient in 10) are headache, joint pain, muscle ache, pain at injection site and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Pumarix (dehru f'aktar minn pazjent 1 f'10) huma wġigħ ta' ras, uġigħ fil-ġogi, uġigħ fil-muskoli, uġig fil-punt fejn saret l-injezzjoni u għeja kbira.
English: Dosing recommendations are only available for adults.
Maltese: Irrakkomandazzjonijiet ta' dożaġġ huma disponibbli biss għall-adulti.
English: When the company that makes the vaccine includes in it the flu strain responsible for a pandemic, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Maltese: Meta l-kumpanija li tagħmel il-vaċċin tinkludi fil-vaċċin ir-razza tal-influwenza li tkun responsabbli għal pandemija, hija għandha tiġbor informazzjoni dwar is-sigurtà u l-effikaċja tal-vaċċin pandemiku finali, u tissottomettiha lis-CHMP għall-evalwazzjoni.
English: The second study showed that Pumarix was able to trigger the production of antibodies to a level high enough to meet CHMP criteria.
Maltese: It-tieni studju wera li Pumarix kien kapaċi jqanqal il-produzzjoni ta' antikorpi sa livell għoli biżżejjed li jissodisfa l-kriterji tas-CHMP.
English: Pumarix is a ‘mock-up' vaccine.
Maltese: Pumarix huwa vaċċin ‘finta'.
English: The vaccine is given by injection into muscle, preferably into shoulder or thigh muscle.
Maltese: Il-vaċċin jingħata b'injezzjoni fil-muskolu, preferibbilment fil-muskolu tal-ispalla jew tal-koxxa.
English: The emulsion contains the ‘adjuvant' to enhance the immune response.
Maltese: L-emulsjoni fiha l-‘adjuvant' biex jittejjeb ir-rispons immunitarju.
English: The vaccine has been authorised under ‘exceptional circumstances'.
Maltese: Il-vaċċin ġie awtorizzat taħt ‘ċirkostanzi eċċezzjonali'.
English: The effects of Pumarix were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Pumarix għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fil
English: Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with an emulsion.
Maltese: Qabel l-użu, il-vaċċin isir minn taħlita ta' sospensjoni li fiha l-partiċelli tal-virus flimkien ma' emulsjoni.
English: Adults should be given a dose of 0.5 ml followed by a second dose after an interval of at least three weeks.
Maltese: L-adulti għandhom jingħataw doża ta' 0.5 ml segwita bit-tieni doża wara intervall ta' mill-anqas tliet ġimgħat.
English: It contains parts of influenza (flu) viruses that have been inactivated (killed).
Maltese: Fih partijiet ta' virusis tal-influwenza li ġew diżattivati (maqtula).
English: • Psoriasis
Maltese: • Psorjażi
English: Frequency “Not known”
Maltese: Frekwenza “Mhux magħruf”
English: Teriflunomide - Psoriasis (EPITT no 19366)
Maltese: Teriflunomide - Psorjażi (EPITT nru 19366)
English: Ibuprofen - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 19409)
Maltese: Ibuprofen - Pustulożi esantematika ġeneralizzata akuta (AGEP) (EPITT nru 19409)
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors2New information on the known association between SGLT2 inhibitors and diabetic ketoacidosis in surgical patients (EPITT no 19355)
Maltese: Inibituri tal-kotrasportatur 2 ta' sodium-glucose (SGLT2)2 - Informazzjoni ġdida dwar l-assoċjazzjoni magħrufa bejn linibituri ta' SGLT2 u l-ketoaċidożi dijabetika f'pazjenti kirurġiċi (EPITT nru 19355)
English: For ibuprofen and pseudoephedrine combinations 4.4.
Maltese: Għall-kombinazzjonijiet ta' ibuprofen u pseudoephedrine 4.4.
English: Ibrutinib - Ischaemic stroke (EPITT no 19369)
Maltese: Ibrutinib - Puplesija iskemika (EPITT nru 19369)
English: Summary of product characteristics 4.4.
Maltese: Sommarju tal-karatteristiċi tal-prodott 4.4.
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDSs (see section 4.8).
Maltese: Reazzjonijiet serji tal-ġilda, uħud minnhom fatali, inklużi dermatite esfoljattiva, sindrome ta' StevensJohnson, u nekroliżi epidermali tossika ġew irrappurtati f'każijiet rari f'assoċjazzjoni mal-użu ta' NSAIDSs (ara sezzjoni 4.8).
English: 1 Only if the already existing AGEP ADR in section 4.8 is listed specifically for pseudoephedrine.
Maltese: 1 Jekk l-ADR AGEP diġà eżistenti fis-sezzjoni 4.8 hija elenkata speċifikament għal pseudoephedrine biss.
English: Uncommon: cerebrovascular accident, transient ischaemic attack, ischaemic stroke
Maltese: Mhux komuni: aċċident ċerebrovaskulari, attakk iskemiku temporanju, puplesija iskemika
English: Undesirable effects Tabulated list of adverse reactions Nervous system disorders
Maltese: .8. Effetti mhux mixtieqa Lista f'tabella ta' reazzjonijiet avversi
English: Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products.
Maltese: Ġiet irrappurtata pustulożi esantematika ġeneralizzata akuta (AGEP) b'rabta ma' prodotti li fihom ibuprofen.
English: Latency from the initiation of treatment with ibrutinib to the onset of ischemic central nervous vascular conditions was in the most cases after several months (more than 1 month in 78% and more than 6 months in 44% of cases) emphasizing the need for regular monitoring of patients (please see section 4.4 Cardiac arrhythmia and Hypertension and section 4.8).
Maltese: Il-latenza mill-bidu tat-trattament b'ibrutinib mal-bidu ta' kundizzjonijiet vaskulari nervużi ċentrali iskemiċi kienet fil-biċċa l-kbira tal-każijiet wara diversi xhur (aktar minn xahar fi 78 % u aktar minn 6 xhur f'44 % tal-każijiet) li enfasizzat il-ħtieġa għal monitoraġġ regolari tal-pazjenti (jekk jogħġbok ara sezzjoni 4.4
English: Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency not known: Psoriasis (including pustular psoriasis)b b: see section 4.4
Maltese: Psorjażi (inkluż psorjażi pustulari)b b: ara sezzjoni 4.4
English: Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with ibuprofen and pseudoephedrine-containing products.
Maltese: Reazzjonijiet severi tal-ġilda bħal pustulożi esantematika ġeneralizzata akuta (AGEP) jistgħu jseħħu b'ibuprofen u prodotti li jkun fihom pseudoephedrine.
English: Tell your doctor immediately if you notice or someone notices in you: sudden numbness or weakness in the limbs (especially on one side of the body), sudden confusion, trouble speaking or understanding speech, sight loss, difficulty walking, loss of balance or lack of coordination, sudden severe headache with no known cause.
Maltese: Għid lit-tabib tiegħek immedjatament jekk tinnota jew xi ħadd ieħor jinnota fik: tnemnim jew dgħufija f'daqqa fid-dirgħajn u fir-riġlejn (speċjalment fuq naħa waħda tal-ġisem), konfużjoni f'daqqa, diffikultà biex titkellem jew tifhem id-diskors, telf tal-vista, diffikultà biex timxi, telf ta' bilanċ jew nuqqas ta' koordinazzjoni, uġigħ ta' ras sever f'daqqa mingħajr l-ebda kawża magħrufa.
English: Monitoring of ketones is recommended in these patients.
Maltese: It-test attwali li għandu jitħassar huwa maqtugħ.
English: Ibuprofen should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.
Maltese: Ibuprofen għandu jitwaqqaf, mal-ewwel dehra ta' sinjali u sintomi ta' reazzjonijiet severi talġilda, bħal raxx tal-ġilda, leżjonijiet mukużi, jew kwalunkwe sinjal ieħor ta' sensittività eċċessiva.
English: Adopted at the 2-5 September 2019 PRAC
Maltese: Adottata fil-PRAC ta' bejn it-2 u l-5 ta' Settembru 2019
English: Measurement of blood ketone levels is preferred to urine.
Maltese: Il-kejl tal-livelli tal-ketone tad-demm huwa ppreferut mill-awrina.
English: What you need to know before you take IMBRUVICA
Maltese: X'għandek tkun taf qabel ma tieħu IMBRUVICA
English: For ibuprofen monotherapy or ibuprofen in combinations excluding combinations with pseudoephedrine
Maltese: Għal monoterapija ta' ibuprofen jew ibuprofen f'kombinazzjonijiet bl-esklużjoni ta' kombinazzjonijiet ma' pseudoephedrine
English: Special warnings and precautions for use Diabetic ketoacidosis
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu Ketoaċidożi dijabetika
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli)
English: The full EPAR for Synflorix 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: Synflorix contains the polysaccharides from ten different types of S. pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).
Maltese: Synflorix għandu fih il-polisakkaridi minn 10 tipi differenti ta' S. pneumoniae(serotipi 1, 4, 5, 6B, 7F, 9V, 14, 18Ċ, 19F u 23F).
English: Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Maltese: Vaċċin polisakkaridiku pnewmokokkiku konjugat (assorbit)
English: For the three additional polysaccharides (1, 5, 7F), Synflorix was effective in triggering the production of antibodies.
Maltese: Għat-tliet polisakkaridi addizzjonali (1, 5, 7F), Synflorix kien effettiv fl-istimulazzjoni tal-produzzjoni ta' antikorpi.
English: Synflorix is a vaccine that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae, also called pneumococcus).
Maltese: Synflorix huwa vaċċin li fih partijiet tal-batterju Streptococcus pneumoniae (S. pneumoniae, imsejjaħ ukoll pneumococcus).
English: This is a summary of the European public assessment report (EPAR) for Synflorix.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Synflorix.
English: The percentage of children who had bacterial pneumonia was 2.3% (240 out of over 10,000) among those given Synflorix compared with 3% (304 out of over 10,000) among those given the comparator.
Maltese: Il-perċentwal ta' tfal li kellhom pulmonite batterika kien ta' 2.3% (240 minn 10,000) fost dawk li ngħataw Synflorix meta mqabbla mat-3% (304 minn aktar minn 10,000) fost dawk li ngħataw il-vaċċin komparatur.
English: Synflorix is available as a suspension for injection.
Maltese: Synflorix huwa disponibbli bħala sospensjoni għal injezzjoni.