FrancophonIA/ELRC3.0 huggingface dataset:
English: Throat tightness, Nasal oedema, Nasal dryness
Maltese: Għafis fuq il-gerżuma, Edema nażali, Imnieħer xott
English: Vizarsin 50 mg orodispersible tablets
Maltese: Vizarsin 50 mg pilloli miksija b'rita:
English: Vizarsin is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Maltese: Vizarsin huwa trattament għal irġiel li għandhom problema biex jibbies il-pene, li kultant hi magħrufa bħala impotenza.
English: 4 x 1 film-coated tablet: EU/1/09/551/002 8 x 1 film-coated tablet: EU/1/09/551/003
Maltese: EU/1/09/551/002 8 x 1 pillola miksija:
English: Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process.
Maltese: Studji in vitro wrew li sildenafil huwa selettiv għal PDE5, li huwa involut fil-proċess ta' twebbis.
English: 28703 San Sebastian de los Reyes (Madrid) Spain
Maltese: 28703 San Sebastian de los Reyes (Madrid) Spanja
English: Czech Republic TEVA Czech Industries s.r.o.
Maltese: Repubblika Ċeka TEVA Czech Industries s.r.o.
English: Iskedyl Fort tablets
Maltese: Iskedyl Fort pilloli
English: Arzneimittelvertriebs GmbH, Anton Anderer Platz 6/1, A-1210 Vienna Austria
Maltese: Arzneimittelvertriebs GmbH, Anton Anderer Platz 6/1, A-1210 Vienna Awstrija
English: 0.10 g / 0.80 g oral solution
Maltese: 0.10 g / 0.80 g soluzzjoni orali
English: ISKEDYL, solution buvable en flacon
Maltese: ISKEDYL, soluzzjoni buvable en flacon
English: ARKOLEON 11, KATO PATISSIA, 10445 Greece
Maltese: ARKOLEON 11, KATO PATISSIA, 10445
English: 18TH Km MARATHONOS AVENUE, PALLINI, ATTIKIS, 15351
Maltese: Km MARATHONOS AVENUE, PALLINI, ATTIKIS, 15351
English: FINIXFARM EPE DERVENAKION 38 & SAHINI, GERAKAS, 15344 Greece
Maltese: FINIXFARM EPE DERVENAKION 38 & SAHINI, GERAKAS, 15344
English: PRT Lagoas Park, Edifício 11 2740-270 Porto Salvo Portugal
Maltese: PRT Lagoas Park, Edifício 11 2740-270
English: Capsule hard
Maltese: Kapsula iebsa
English: ARGONAFTWN 22, ARGYROUPOLI, 16452 Greece
Maltese: ARGONAFTWN 22, ARGYROUPOLI, 16452 Greċja
English: PHARM O.E.
Maltese: J.A. PHARM O.E.
English: Ferraz 80, 5º 28008 Madrid Spain
Maltese: TORA LABORATORIES S.L. Ferraz 80, 5º 28008 Madrid Spanja
English: G. KORONIS DILOU 9, PERISTERI, ATTIKIS, 12134 Greece
Maltese: KORONIS DILOU 9, PERISTERI, ATTIKIS, 12134
English: 3mg/cap capsules, soft
Maltese: 3mg/cap kapsuli, rotob
English: 2.5 mg (1:1:1) prolonged-release capsule, soft
Maltese: 2.5 mg (1:1:1) kapsuli li jtawwlu leffett, rotob
English: ISKEDYL, solution injectable en ampoule solution for injection IV/IM
Maltese: ISKEDYL, soluzzjoni injectable en ampoule soluzzjoni għallinjezzjoni
English: ANTOR LTD P. MAVROMIHALI 1 VRILISSIA 15235 Greece
Maltese: MAVROMIHALI 1 VRILISSIA 15235 Greċja
English: 747 70 Opava-Komárov Czech Republic
Maltese: Opava-Komárov Repubblika Ċeka
English: S.J.A.
Maltese: A.E.
English: LEOVAN, M. LEWN & SIA EE
Maltese: LEOVAN, M.
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Maltese: Lista tal-ismijiet, forma farmaċewtika, qawwa tal-prodott(i) mediċinali,
English: This summary was last updated in November 2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Novembru 2016.
English: The full EPAR for Coliprotec F4/F18 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: E. coli O8:K87 / O141:K94 vaccine (live)
Maltese: Tilqima (ħajja) ta' E. coli O8:K87 / O141:K94
English: Coliprotec F4/F18 contains two strains of live E. coli bacteria (O8:K87 and O141:K94) which do not produce toxins that cause disease.
Maltese: Coliprotec F4/F18 fih żewġ razez ta' batterji ħajjin ta' E. coli (O8:K87 u O141:K94) li ma jipproduċux tossini li jikkawżaw il-mard.
English: The European Commission granted a marketing authorisation valid throughout the EU for Coliprotec F4/F18 on 9 January 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Coliprotec F4/F18 fi 09/01/2017.
English: Pigs aged 17 - 18 days were vaccinated with Coliprotec F4/F18 and then artificially infected with E. coli strains.
Maltese: Ħnieżer ta' bejn 17 - 18-il jum ġew imlaqqma b'Coliprotec F4/F18 u mbagħad ġew artifiċjalment infettati b'razez ta' E. coli.
English: Coliprotec F4/F18 is available as a lyophilisate (a freeze-dried pellet) which is made up into a suspension with water to be given by mouth.
Maltese: Coliprotec F4/F18 huwa disponibbli bħala lijofilizzat (pelit imnixxef bil-friża) li jiġi magħmul f'sospensjoni bl-ilma sabiex tingħata mill-ħalq.
English: Coliprotec F4/F18 is a vaccine used to protect pigs from 18 days of age against post-weaning diarrhoea caused by E. coli.
Maltese: Coliprotec F4/F18 huwa tilqima li tintuża sabiex tipproteġi lill-ħnieżer ta' aktar minn 18-il jum kontra d-dijarea wara l-ftim ikkawżata minn E. coli.
English: This is a summary of the European public assessment report (EPAR) for Coliprotec F4/F18.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Coliprotec F4/F18.
English: Coliprotec F4/F18 is a vaccine.
Maltese: Coliprotec F4/F18 huwa tilqima.
English: The types of E. coli associated with post-weaning diarrhoea often produce proteins called F4 and F18 on their outer coat that allows them to attach to the cells of the gut.
Maltese: Ħafna drabi t-tipi ta' E. coli assoċjati ma' dijarea wara l-ftim jipproduċu proteini msejħa F4 u F18 fuq il-kisja ta' barra tagħhom li jippermettilhom li jeħlu maċ-ċelluli tal-musrana.
English: Although E. coli bacteria are naturally found in the gut, some strains (known as enterotoxigenic strains) produce toxins that cause diarrhoea and can result in dehydration, weight loss and occasionally death of the animal.
Maltese: Għalkemm il-batterji E. coli jinstabu b'mod naturali fl-imsaren, xi razez (magħrufa bħala razez enterotossiġeniċi) jipproduċu tossini li jikkawżaw dijarea u jistgħu jwasslu għal deidrazzjoni, telf fil-piż u kultant mewt tal-annimal.
English: Why is Coliprotec F4/F18 approved?
Maltese: Għaliex ġie approvat Coliprotec F4/F18?
English: What are the risks associated with Coliprotec F4/F18?
Maltese: X'inhuma r-riskji assoċjati ma' Coliprotec F4/F18?
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: It-tilqim jaħdem billi ‘jgħallem' lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra marda.
English: Other information about Coliprotec F4/F18?
Maltese: Kif jintuża Coliprotec F4/F18?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Coliprotec F4/F18's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Coliprotec F4/F18 huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The vaccine starts to be effective 7 days after vaccination and protection lasts for 21 days after vaccination.
Maltese: It-tilqima jibda jkollha effett sebat ijiem wara li tingħata u l-protezzjoni ddum għal 21 jum wara l-għoti tat-tilqima.
English: The full EPAR for Vosevi 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: Vosevi is available as tablets containing 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir.
Maltese: Vosevi jiġi bħala pilloli li fihom 400 mg sofosbuvir, 100 mg velpatasvir u 100 mg voxilaprevir.
English: • carbamazepine, phenobarbital, phenytoin (medicines for epilepsy);
Maltese: • carbamazepine, phenobarbital, phenytoin (mediċini għall-epilessija);
English: Other information about Vosevi
Maltese: Informazzjoni oħra dwar Vosevi
English: • rifampicin, rifabutin (antibiotics usually used to treat tuberculosis);
Maltese: • rifampicin, rifabutin (antibijotiċi li normalment jintużaw għall-kura tat-tuberkulożi);
English: This is a summary of the European public assessment report (EPAR) for Vosevi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vosevi.
English: Sofosbuvir blocks the action of an enzyme (a type of protein) called ‘NS5B RNA-dependent RNA polymerase', velpatasvir targets a protein called ‘NS5A', while voxilaprevir blocks an enzyme called NS3/4A protease.
Maltese: Sofosbuvir jimblokka l-azzjoni ta' enzima (tip ta' proteina) li tissejjaħ “NS5B polimerażi dipendenti fuq RNA”, velpatasvir jimmira proteina li tissejjaħ “NS5A”, waqt li voxilaprevir jimblokka enzima li tissejjaħ protease NS3/4A.
English: Sofosbuvir/velpatasvir has been authorised in the EU as Epclusa since July 2016.
Maltese: Sofosbuvir/velpatasvir ilu awtorizzat fl-UE bħala Epclusa minn Lulju 2016.
English: Vosevi contains the active substances sofosbuvir, velpatasvir and voxilaprevir.
Maltese: Vosevi fih is-sustanzi attivi sofosbuvir, velpatasvir u voxilaprevir.
English: Vosevi is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus (HCV).
Maltese: Vosevi huwa mediċina antivirali użata biex tikkura adulti b'epatite Ċ kronika (fit-tul), marda infettiva li taffettwa l-fwied, ikkawżata mill-virus tal-epatite Ċ (HCV).
English: In two further studies between 95 and 96% of Vosevi patients tested negative for the virus, compared with 96 to 98% of patients taking sofosbuvir/velpatasvir.
Maltese: F'żewġ studji oħra bejn 95 u 96 % tal-pazjenti ta' Vosevi ttestjaw negattivi għall-virus, meta mqabbel ma' 96 sa 98 % tal-pazjenti li kienu qed jieħdu sofosbuvir/velpatasvir.
English: The active substances in Vosevi (sofosbuvir, velpatasvir and voxilaprevir) block three proteins essential for the hepatitis C virus to multiply.
Maltese: Is-sustanzi attivi f'Vosevi (sofosbuvir, velpatasvir u voxilaprevir) jimblukkaw tliet proteini li huma essenzjali biex il-virus tal-epatite Ċ jimmultiplika.
English: What are the risks associated with Vosevi?
Maltese: X'inhuma r-riskji assoċjati ma' Vosevi?
English: • dabigatran etexilate (medicine for preventing blood clots);
Maltese: • dabigatran etexilate (mediċina biex tipprevjeni l-koagulazzjoni);
English: • St John's wort (a herbal remedy used for depression and anxiety).
Maltese: • St John's wort (rimedju erbali li jintuża għad-dipressjoni u għall-ansjetà).
English: • ethinyl oestradiol-containing products (such as contraceptive medicines);
Maltese: • prodotti li fihom ethinyl estradiol (bħal mediċini kontraċettivi);
English: Why is Vosevi approved?
Maltese: Għaliex ġie approvat Vosevi?
English: Over 97% of patients taking Vosevi in a second study tested negative, compared with 90% of patients taking only sofosbuvir/velpatasvir.
Maltese: Aktar minn 97 % tal-pazjenti li kienu qed jieħdu Vosevi, fit-tieni studju ttestjaw negattivi, meta mqabbel ma' 90 % tal-pazjenti li kienu qed jieħdu sofosbuvir/velpatasvir biss.
English: Vosevi has been shown in four main studies of 1,459 patients to be effective at clearing all six varieties (genotypes) of the hepatitis C virus, including in patients with liver cirrhosis and those who have previously tried other direct-acting antivirals.
Maltese: F'erba' studji ewlenin ta' 1,459 pazjent, Vosevi ntwera li huwa effettiv biex ineħħi s-sitt varjetajiet (ġenotipi) kollha tal-virus tal-epatite Ċ, inkluż f'pazjenti b'ċirrożi tal-fwied u f'dawk li ġew ikkurati preċedentement b'antivirali oħra b'azzjoni diretta.
English: Over 96% of patients taking Vosevi in one study tested negative for HCV (their blood tests did not show any sign of the virus) after 12 weeks of treatment, compared with none of the patients who received placebo (a dummy treatment).
Maltese: Aktar minn 96 % tal-pazjenti li kienu qed jieħdu Vosevi, fi studju wieħed, ittestjaw negattivi għall-HCV (it-testijiet tad-demm tagħhom ma wrew l-ebda sinjal tal-virus) wara 12-il ġimgħa ta' kura, meta mqabbel ma' ħadd mill-pazjenti li rċevew il-plaċebo (kura finta).
English: What measures are being taken to ensure the safe and effective use of Vosevi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Vosevi?
English: For the full list of side effects and restrictions with Vosevi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Vosevi, ara l-fuljett ta' tagħrif.
English: How does Vosevi work?
Maltese: Kif jintuża Vosevi?
English: The company that markets Vosevi will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals.
Maltese: Il-kumpanija li tqiegħed Vosevi fis-suq se tagħmel studju fuq pazjenti li preċedentement kellhom kanċer tal-fwied sabiex tevalwa r-riskju li jirritorna l-kanċer tal-fwied wara kura b'antivirali b'azzjoni diretta.
English: How is Vosevi used?
Maltese: Kif jaħdem Vosevi?
English: The European Medicines Agency therefore decided that Vosevi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għaldaqstant, l-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefi ċċji ta' Vosevi hu riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: • rosuvastatin (medicine for lowering cholesterol in the blood);
Maltese: • rosuvastatin (mediċina biex tbaxxi l-livelli tal-kolesterol fid-demm);
English: By blocking these proteins, Vosevi stops the hepatitis C virus from multiplying and infecting new cells.
Maltese: Billi jimblokka dawn ilproteini, Vosevi jwaqqaf il-virus tal-epatite Ċ milli jimmultiplika u jinfetta ċelloli ġodda.
English: EU/1/00/167/005
Maltese: EU/1/00/167/001 EU/1/00/167/002 EU/1/00/167/005
English: 2 micrograms
Maltese: 2 mikrogrammi
English: Effectiveness
Maltese: Effettività
English: Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Maltese: Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Ir-Renju Unit
English: Official Medicines Control Laboratory (OMCL) Agence Française de Sécurité Sanitaire des Produits de Santé Direction des laboratoires et des contrôles Avenue Jean Jaurès, 321
Maltese: Laboratorju Uffiċjali tal-Kontroll tal-Mediċini (OMCL) Agence Française de Sécurité Sanitaire des Produits de Santé Direction des laboratoires et des contrôles Avenue Jean Jaurès, 321
English: CRM197, Activated Saccharides, and Conjugates Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park
Maltese: CRM197, Saccharides Attivati, u Konjugati Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park
English: WHO technical report No 927, 2005; Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
Maltese: Rapport tekniku tal-WHO Nru. 927, 2005; Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants (Appendiċi tal-kriterji serologiċi għall-kalkulazzjoni u l-illiċenzjar ta' formulazzjonijiet ġodda ta' tilqim b'konjugat pnewmokokkali għall-użu fit-trabi).
English: Infants aged 2 - 6 months:
Maltese: Trabi ta' bejn 2 - 6 xhur:
English: • Fever of 39°C or higher
Maltese: • Deni ta' 39°C jew ogħla
English: * Conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg)
Maltese: * Konjugat għall-proteina carrier CRM197 u adsorbit fuq aluminium phosphate (0.5 mg)
English: Sodium chloride Water for injections
Maltese: Sodium chloride
English: Each 0.5 ml dose contains 2 micrograms of saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 micrograms of serotype 6B per dose (16 micrograms total saccharide) conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg).
Maltese: Kull doża ta' 0.5 ml fiha 2 mikrogrammi ta' saccharide għas-serotipi 4, 9V, 14, 18C, 19F, u 23F, u 4 mikrogrammi ta' serotip 6B f'kull doża (total ta' 16-il mikrogramma ta' saccharide) konjugat għal CRM197 proteina carrier u adsorbit fuq aluminju phosphate (0.5 mg).
English: Date of first authorisation: 02/02/2001
Maltese: Data ta' l-ewwel awtorizzazzjoni: 02/02/2001
English: • Hypotonic-hyporesponsive episode (collapse or shock-like state)
Maltese: • Episodju ipotoniku-iporisponsiv (kollass jew stat qisu xokk)
English: Pfizer AS Tlf: +47 67 526 100
Maltese: Tlf: +47 67 526 100
English: • A fourth injection (booster) will be given between 11 and 15 months of age
Maltese: • Ir-raba' injezzjoni (booster) ser tingħata bejn l-età ta' 11 u 15-il xahar
English: Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Maltese: Il-batterji jistgħu jkunu responsabbli għal 60-70% tal-episodji kliniċi ta' AOM.
English: Apnoea in very premature infants ( 28 weeks of gestation) (see section 4.4).
Maltese: Apnea fi trabi prematuri ħafna ( 28 ġimgħa ta' tqala) (ara sezzjoni 4.4).
English: Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from 2 months up to 5 years of age (see sections 4.2, 4.4 and 5.1).
Maltese: Tilqima attiva kontra mard ikkawżat minn Streptococcus pneumoniae serotipi 4, 6B, 9V, 14, 18C, 19F u 23F (li jinkludi sepsis, meninġite, pnewmonja, batteremija u infjammazzjoni akuta fil-parti tan-nofs tal-widna) fi trabi u fi tfal minn xahrejn sa 5 snin (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: In the Kaiser Permanente trial, efficacy was 87.5 % (95 % CI: 7, 99) against bacteraemic pneumonia due to vaccine serotypes of S. pneumoniae.
Maltese: Fil-prova Kaiser Permanente, l-effikaċja kienet ta' 87.5% (95% CI: 7, 99) kontra l-pnewmonja batteremika minħabba s-serotipi tat-tilqima ta' S. pneumoniae.
English: EXP:
Maltese: Komuni:
English: Theoretically, Prevenar could prevent about 6080% of serotypes causing pneumococcal AOM.
Maltese: Teoretikament, Prevenar jista' jevita madwar 60-80% tas-serotipi li jikkawżaw AOM pnewmokokkali.
English: Estimates of efficacy against invasive disease were obtained in the US population where vaccine serotype coverage ranged from 80 to 89 %.
Maltese: Stimi tal-effikaċja kontra mard invażiv inkisbu fil-popolazzjoni Amerikana, fejn il-kopertura tasserotip tat-tilqima varjat minn 80 sa 89%.
English: In Quebec, Canada Prevenar was introduced at 2, 4 and 12 months of age with a single dose catch-up programme in children up to 5 years of age.
Maltese: Fi Quebec, Canada Prevenar kien introdott f'età ta' 2, 4 u 12-il xahar bi programm ta' doża waħda catch-up fi tfal li kellhom sa 5 snin.
English: More than 37,816 infants were immunised with either Prevenar or a control vaccine (meningococcal conjugate group C vaccine), at 2, 4, 6 and 12-15 months of age.
Maltese: Iktar minn 37,816 tarbija ngħataw tilqima jew bi Prevenar, jew b'tilqima tal-kontroll (tilqima ta' grupp Ċ konjugat meningokokkali), wara 2, 4, 6 u 12-15-il xahar.
English: Inconsistent reduction in response to pertussis antigens as well as to inactivated polio vaccine (IPV) were observed.
Maltese: Tnaqqis inkonsistenti fir-rispons għall-antiġeni tal-pertussis, kif ukoll għat-tilqima tal-polio inattivata (inactivated polio vaccine - IPV) kien osservat.
English: Pharmacotherapeutic group: pneumococcal vaccines, ATC code: J07AL02
Maltese: Kategorija farmakoterapewtika: tilqim pnewmokokkali, Kodiċi ATC:
English: The immunogenicity of Prevenar has been investigated in an open-label, multicenter study in 49 infants with sickle cell disease.
Maltese: L-immunoġeniċità ta' Prevenar kienet investigata fi studju open-label, multiċentriku f'49 tarbija bilmarda taċ-ċelluli sickle.
English: Pneumococcal polysaccharide serotype 23F*
Maltese: Serotip polysaccharide pnewmokokkali 23F*
English: Tympanostomy tube placement was reduced by 24 % (95 % CI: 12, 35) in the per-protocol analysis and by 23 % (95 % CI: 11, 34) in the intent-to-treat analysis.
Maltese: Ilfrekwenza tat-tqegħid ta' tubu tat-timpanostomija tnaqqset b'24% (95% CI: 12, 35) fl-analiżi skont ilprotokoll u 23% (95% CI: 11, 34) fl-analiżi intent-to-treat.
English: Efficacy of Prevenar against acute otitis media (AOM) was assessed in a randomised, double blind, clinical trial of 1,662 Finnish infants immunised with either Prevenar or a control vaccine (Hepatitis B vaccine), at 2, 4, 6 and 12-15 months of age.
Maltese: L-effikaċja ta' Prevenar kontra infjammazzjoni akuta fil-parti tan-nofs tal-widna (acute otitis mediaAOM) kienet evalwata fi prova klinika randomised, double blind, fuq 1,662 tarbija Finlandiżi li ngħataw tilqima jew bi Prevenar, jew b'tilqima tal-kontroll (tilqima kontra l-Epatite B), wara 2, 4, 6 u 12-15-il xahar ta' età.
English: Efficacy of Prevenar against AOM was assessed as a secondary endpoint in the Kaiser Permanente trial.
Maltese: L-effikaċja ta' Prevenar kontra AOM kienet evalwata bħala riżultat aħħari sekondarju fil-prova Kaiser Permanente.
English: The estimate for vaccine efficacy against vaccine-serotype AOM, the primary endpoint of the trial, was 57 % (95 % CI: 44, 67) in the per-protocol analysis and 54 % (95 % CI: 41, 64) in the intent-to-treat analysis.
Maltese: L-istima għall-effikaċja tat-tilqima kontra t-tilqima-serotip AOM, ir-riżultat aħħari primarju tal-prova, kienet ta' 57% (95% CI: 44, 67) fl-analiżi skont il-protokoll u 54% (95% CI: 41, 64) fl-analiżi intent-to-treat.
English: The vaccine is a homogeneous white suspension.
Maltese: It-tilqima hi suspensjoni bajda omoġenja.
English: It is estimated that Prevenar could prevent 6-13% of all
Maltese: Hu stmat li Prevenar jista' jevita 6-13% tal-episodji kliniċi kollha
English: Marketing Authorisation Holder:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Hypotonic hyporesponsive episode, injection site hypersensitivity reactions (eg., dermatitis, pruritus, urticaria), flushing.
Maltese: Episodju iporisponsiv ipotoniku, reazzjonijiet ta' sensittività eċċessiva fis-sit tal-injezzjoni (eż., dermatite, ħakk, urtikarja), fwawar.
English: Prevenar suspension for injection Pneumococcal saccharide conjugated vaccine, adsorbed
Maltese: Prevenar suspensjoni għall-injezzjoni Tilqima konjugata saccharide pnewmokokkali, adsorbita
English: When Prevenar is co-administered with hexavalent vaccines (DTaP/Hib(PRP-T)/IPV/HepB), fever ≥ 38 °C per dose was reported in 28.3 % to 48.3 % of infants in the group receiving Prevenar and the hexavalent vaccine at the same time as compared to 15.6 % to 23.4 % in the group receiving the hexavalent vaccine alone.
Maltese: Meta Prevenar jingħata flimkien ma' tilqim eżavalenti (DTaP/Hib(PRP-T)/IPV/HepB), deni b'temperatura ta' ≥ 38°C kull doża kien irrappurtat fi 28.3% sa 48.3% tat-trabi fil-grupp li kien qed jirċievi Prevenar u t-tilqima eżavalenti fl-istess ħin meta mqabbel ma' 15.
English: A 33 % (95 % CI: -1, 80) increase in AOM due to serogroups not included in the vaccine was observed in immunised subjects.
Maltese: Żieda ta' 33% (95% CI: -1, 80) fl-AOM minħabba serogruppi li ma kinux inklużi fit-tilqima kienet osservata f'pazjenti immunizzati.
English: The immune response to routine paediatric vaccines co-administered with Prevenar at different injection sites was assessed in 7 controlled clinical studies.
Maltese: Ir-rispons immuni għat-tilqim pedjatriku ta' rutina mogħti flimkien ma' Prevenar f'siti differenti talinjezzjoni, kien evalwat f'7 studji kliniċi kkontrollati.
English: A total of 52 cases of invasive disease caused by vaccine serotypes had accumulated in a blinded followup period through April 20, 1999.
Maltese: Total ta' 52 każ ta' mard invażiv ikkawżat minn serotipi tat-tilqima, akkumula f'perjodu blinded follow-up sal-20 t'April, 1999.
English: Fever of > 39 °C was reported in 3.3 % of children compared to 1.2 % in the control group.
Maltese: Deni b'temperatura ta' > 39°C kien irrappurtat fi 3.3% tat-tfal meta mqabbel ma' 1.2% fil-grupp talkontroll.