FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
Maltese: Il-fattur IX tal-koagulazzjoni rikombinanti li huwa glikoproteina ta' katina waħda b'piż molekulari ta' madwar 55,000 Daltons, jagħmel parti mill-grupp ta' serine protease tal-fatturi ta' koagulazzjoni dipendenti fuq il-vitamina K tal-fattur IX tal-koagulazzjoni rikombinanti li hi proteina terapewtika bbażata fuq id-DNA rikombinanti li għandha karatteristiċi strutturali u ta' funzjoni komparabbli mal-fattur IX endoġenu.
English: Strength of BeneFIX per ml prepared solution
Maltese: Il-qawwa ta' BeneFIX għal kull 1 ml ta' soluzzjoni ppreparata
English: Pharmacokinetic Parameter Estimates for BeneFIX (75 IU/kg) at Baseline and Month 6 in Previously Treated Patients with Haemophilia B
Maltese: IU/kg) fil-Linja Bażi u Xahar 6 f'Pazjenti b'Emofilja B Ikkurati Preċedentament Parametru
English: Dose and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of bleeding, and on the patient's clinical condition.
Maltese: Id-doża u t-tul tat-terapija ta'sostituzzjoni jiddependu fuq is-severità tad-defiċjenza tal-fattur IX, fuq il-lok u l-ammont ta' fsada, u fuq il-kondizzjoni klinika tal-pazjent.
English: No adverse events have been reported in association with this observation.
Maltese: S'issa, ma ġewx irrappurtati episodji avversi assoċjati ma' din l-osservazzjoni.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 100 IU nonacog alfa.
Maltese: 234%) sodium chloride li hi pprovduta miegħu, kull 1 mL ta' soluzzjoni jkun fih madwar 100 IU nonacog alfa.
English: It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Maltese: Huwa mportanti li tkun taf li pazjenti b'impeditur tal-fattur IX jistgħu jkunu f'riskju ogħla ta' anaflassi bi sfida sussegwenti mal-fattur IX.
English: Inadequate factor IX recovery p,
Maltese: Tneħħix l-adapter millpakkett.
English: Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, generalised urticaria, itching, tightness of the chest, bronchospasm, laryngospasm, wheezing, hypotension, blurred vision, and anaphylaxis.
Maltese: urtikarja, urtikarja ġeneralizzata, ħakk, tagħfis fis-sider, bronkospażmu, larinġospażmu, tisfir man-nifs, pressjoni baxxa, vista mċajpra u anafilassi.
English: People who are born with haemophilia B (Christmas disease) lack sufficient factor IX to control bleeding.
Maltese: Persuni li jitwieldu bl-emofilja B (marda ta' Christmas) m'għandhomx fattur IX suffiċjenti biex jikkontrollaw il-fsada.
English: - A kidney disorder (nephrotic syndrome) has been reported following high doses of plasma-derived factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Maltese: - Ġie rrappurtat disturb fil-kliewi (sindrome nefrotiku) wara dożi għoljin ta' fattur IX derivat millplażma f'pazjenti li kellhom emofilja B b'inibituri tal-fattur IX u storja ta' reazzjonijiet allerġiċi.
English: A clinically relevant, low responding inhibitor was detected in 1 out of 65 BeneFIX patients (including 9 patients participating only in the surgery study) who had previously received plasmaderived products.
Maltese: Impeditur li jirrispondi ftit u li hu klinikament rilevanti nstab f'wieħed minn 65 pazjent ta' BeneFIX (li kienu jinkludu 9 pazjenti li ħadu sehem fl-istudju kirurġiku) li qabel kienu ħadu prodotti derivati millplażma.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 50 IU nonacog alfa.
Maltese: Wara r-rikostituzzjoni bis-soluzzjoni għall-injezzjoni ta' 5 mL (0.
English: BeneFIX will be administered by intravenous infusion (IV) after reconstitution with sterile solvent for injection.
Maltese: BeneFIX se jingħata permezz ta' infużjoni ġol-vina (IV) wara rikostituzzjoni b'solvent sterili għallinjezzjoni.
English: • Headache
Maltese: Eżempju:
English: Early signs of allergic reactions include difficulty breathing, shortness of breath, swelling, hives, itching, generalised urticaria, tightness of the chest, wheezing, low blood pressure, blurred vision and anaphylaxis (severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands).
Maltese: Is-sinjali bikrija ta' reazzjonijiet allerġiċi jinkludu diffikultà biex tieħu n-nifs, qtugħ ta' nifs, nefħa, urtikarja, ħakk, urtikarja ġeneralizzata, tagħfis tas-sider, tisfir man-nifs, pressjoni tad-demm baxxa, vista mċajpra u anafilassi (reazzjoni allerġika gravi li tista' toħloq diffikultà biex tibla' u/jew tieħu nnifs, wiċċ u/jew idejn ħomor jew minfuħa).
English: BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni BeneFIX 1000 IU trab u solvent għal soluzzjoni għall-injezzjoni BeneFIX 1500
English: Sufficient data have not been obtained from clinical studies on the treatment of previously untreated patients (PUPs) with BeneFIX.
Maltese: Ma ġietx miksuba biżżejjed informazzjoni minn studji kliniċi dwar il-kura ta' pazjenti mhux trattati qabel (PUPs) b'BeneFIX.
English: - Active Substance:
Maltese: - Sustanza attiva:
English: 7.5 micrograms **
Maltese: 7.5 mikrogrammi**
English: • Format of the simplified PSUR:
Maltese: • Format tal-PSUR issimplifikat:
English: Adults (18-60 years)
Maltese: Adulti (18-60 sena)
English: Systemic
Maltese: Sistemiċi
English: 7.5 micrograms haemagglutinin
Maltese: 7.5 mikrogrammi haemagglutinin
English: - Bell's palsy:
Maltese: - Paraliżi ta' Bell's:
English: - First data-lock point is 30 days later.
Maltese: - L-ewwel data-lock point huwa 30 jum wara.
English: Immunogenicity results with Focetria H1N1v (Study V111_03):
Maltese: Riżultati tal-immunoġeneċità b'Focetria H1N1v (Studju V111_03):
English: Anti-HA antibody
Maltese: Antikorp anti-HA
English: 9.75 milligrams
Maltese: 9.75 milligrammi
English: A/Vietnam/1194/2004 (H5N1)
Maltese: A/Vjetnam/1194/2004
English: The following age groups will be used: < 2 years, 2-8 years, > 9 years.
Maltese: etajiet li ġejjin: < sentejn, 2-8 snin, > 9 snin.
English: • Supportive data in adult and elderly populations
Maltese: • Dejta ta' sostenn f'popolazzjonijiet adulti u anzjani
English: 10 x 10 doses 1 dose (0.5 ml)
Maltese: 10 x 1 doża 1 doża (0.5 ml)
English: Adjuvant MF59C.1 containing: Squalene
Maltese: Adjuvant MF59C.1 li fih Squalene
English: Foclivia contains sodium and potassium
Maltese: Foclivia fih sodium u potassium
English: 0.66 milligrams
Maltese: 0.66 milligrammi
English: Excipients: Thiomersal
Maltese: Thiomersal
English: Very rare (<1/10,000):
Maltese: Rari (>1/10,000, <1/1,000):
English: Date of first authorisation: 19 October 2009 Date of latest renewal: 19 October 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Ottubru 2009 Data tal-aħħar tiġdid: 19 ta' Ottubru 2014
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event
Maltese: Deni ≥ 38°C (≥ 40°C) Kwalunkwe avveniment avvers ieħor
English: 0.04 milligrams
Maltese: 0.04 milligrammi
English: The incidence of adverse reactions was evaluated in four clinical trials with different influenza strains and formulations (H5N3, H9N2 and H5N1); 3696 adults and elderly subjects were exposed.
Maltese: L-inċidenza ta' reazzjonijiet avversi kienet evalwata f'erba' provi kliniċi b'razez u formulazzjonijiet differenti tal-influwenza (H5N3, H9N2 u H5N1); ġew esposti 3696 adult u persuni anzjani.
English: Foclivia contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Maltese: Foclivia fih anqas minn 1 mmol ta' sodium (23 mg) u anqas minn 1 mmol ta' potassium (39 mg) f'kull doża.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR(I)
English: - S-PSUR submission to the Rapporteur and CHMP members on Day 45.
Maltese: - Is-sottomissjoni tal-S-PSUR lir-Rapporteur u lill-membri tas-CHMP f'Jum 45.
English: Cross reactivity
Maltese: Reattività inkroċjata
English: The adjuvant includes also polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Maltese: L-adjuvant jinkludi wkoll polysorbate 80 u sorbitan trioleate f'citrate buffer (sodium citrate, citric acid).
English: Foclivia injection
Maltese: Foclivia injezzjoni.
English: Up to 50% of the elderly subjects immunised with H5N1 vaccine combined with MF59C were seroprotected at six months.
Maltese: Sa 50% tal-individwi anzjani li tlaqqmu b'tilqima kontra H5N1 kombinata ma' MF59C kienu seroprotetti wara sitt xhur.
English: For the adjuvant, see section 2.
Maltese: Għas-sustanza adjuvanted, ara sezzjoni 2.
English: Study V87P1 Adults Booster (6 months after 2nd dose
Maltese: Studju V87P1 Adulti booster (6 xhur wara t-tieni doża)
English: Toddlers (6-<36 months)
Maltese: Trabi (6-<36 xahar)
English: Toddlers (12 to 35 months of age)
Maltese: Tfal żgħar (12 sa 35 xahar)
English: Adults and elderly: 0.5 ml at an elected date.
Maltese: Adulti u anzjani: 0.5 ml f'data magħżula.
English: - Guillain-Barré narrow SMQ “Guillain-Barré syndrome”
Maltese: SMQ dejqa “Is-sindrome ta' Guillain-Barré”
English: narrow SMQ “Convulsions”
Maltese: SMQ dejqa “Konvulżjonijiet”
English: Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Maltese: Deni ≥38°C sa 38.9°C Deni 39°C sa 39.9°C Deni ≥ 40° C
English: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy
Maltese: Martino 53035 Monteriggioni (SI) L-Italja
English: 1 x single dose (0.5 ml) pre-filled syringe with needle 1 x single dose (0.5 ml) pre-filled syringe without needle 10 x single dose (0.5 ml) pre-filled syringes with needle 10 x single dose (0.5 ml) pre-filled syringe without needle
Maltese: 1 x siringa mimlija għal-lest b'labra ta' doża waħda (0.5 ml) 1 x siringa mimlija għal-lest mingħajr labra ta' doża waħda (0.5 mL) 10 x siringi mimlijin għal-lest b'labra ta' doża waħda (0.5 ml) 10 x siringi mimlijin għal-lest mingħajr labra ta' doża waħda (0.5 mL)
English: * measured by SRH assay ≥ 25 mm2
Maltese: * imkejla permezz ta' assaġġ SRH ≥ 25 mm2
English: narrow SMQ “Vasculitis”
Maltese: SMQ dejqa “Vaskulite”
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) and exudative Stevens-Johnson syndrome (erythema multiforme).
Maltese: Vasculitis (infjammazzjoni tal-vini li tista' tikkawża raxxijiet tal-ġilda, uġigħ fil-ġogi u problemi fil-kliewi) u s-sindrome li jnixxi ta' Stevens-Johnson (eritema multiformi).
English: Adolescents (9-<18 years)
Maltese: Adolexxenti (9-<18-il sena)
English: Adolescents (9 to 17 years of age)
Maltese: Adolexxenti (minn 9 sa 17-il sena)
English: EU/1/09/577/001 1 prefilled syringe with needle EU/1/09/577/002 10 prefilled syringes with needle EU/1/09/577/005 1 prefilled syringe without needle EU/1/09/577/006 10 prefilled syringes without needle
Maltese: EU/1/09/577/005 1 siringa mimlija għal-lest mingħajr labra EU/1/09/577/006 10 siringi mimlijin għal-lest mingħajr labra
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Maltese: 6 xhur jew annwali li jaqgħu fil-perjodu tal-pandemija se jiġu ssostitwiti bi “PSURs issimplifikati” (S-PSUR) kull xahar akkompanjati minn sommarju tad-distribuzzjoni tat-tilqima.
English: Children (3-<9 years)
Maltese: Tfal (3-<9 snin)
English: (see section 4.8).
Maltese: (ara sezzjonijiet 4.8 u 5.1).
English: 10 x 1 dose
Maltese: Kunjett 10 x 10 dożi
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Maltese: MF59C.1 emulsjoni ta' żejt fl-ilma li fiha squalene, bħala l-fażi taż-żejt, stabilizzat bi polysorbate 80 u sorbitan trioleate f'buffer ta' citrate (sodium citrate, citric acid).
English: Compared to the antibody levels obtained at day 43 after completion of primary vaccination schedules, antibody levels at day 202 were reduced by 1/5 to 1/2 from their prior levels.
Maltese: Meta mqabbla mal-livelli ta' antikorpi miksuba f'jum 43 wara t-tlestija tal-iskedi tat-tilqim primarju, il-livelli ta' antikorpi f'jum 202 naqsu b'1/5 għal 1/2 il-livelli preċedenti tagħhom.
English: MN results in V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.01 (1.78-2.26).
Maltese: MN fl-istudju V87P13 taw GMR kontra A/turkey/Turkey/05 ta' 2.01 (1.78-2.26).
English: Foclivia has been authorised under “Exceptional Circumstances”.
Maltese: Foclivia kien awtorizzat taħt “Ċirkustanzi Eċċezzjonali”.
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' jkun akkumpanjat minn diversi sinjali newroloġiċi bħal disturbi viżwali temporanji, paraestesija u movimenti toniċi-kloniċi tar-riġlejn matul l-irkupru.
English: Other medicines and Foclivia
Maltese: Mediċini oħra u FOCLIVIA
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Maltese: SMQ dejqa “Demajlinazzjoni” (minħabba li GBS huwa inkluż ukoll f'dan l-SMQ, se jkun hemm overlap fin-numru ta' każijiet għal dawn iż-żewġ kategoriji).
English: Data on a third dose (booster) administered 6 months after the first dose are limited (see sections 4.8 and 5.1).
Maltese: Dejta dwar it-tielet doża (booster) li ngħatat 6 xhur wara l-ewwel doża hija limitata (ara sezzjonijiet 4.8 u 5.1).
English: Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HemoAgglutinin (HA)/dose adjuvanted) were administered three weeks apart to 156 subjects.
Maltese: Żewġ dożi tat-tilqima li kien fihom H5N1 (A/Vjetnam/1194/2004; 7.5 µg HemoAgglutinin (HA)/doża adjuvanted) ingħataw f'intervall ta' tliet ġimgħat lil 156 individwu.
English: MN results in V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
Maltese: MN fl-istudju V87P13 taw GMR kontra A/turkey/Turkey/05 ta' 2.77 (2.4-3.2).
English: OTHER
Maltese: ii)
English: Foclivia contains Thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Maltese: Foclivia fih Thiomersal bħala preservattiv u hu possibbli li jista' jkollok reazzjoni allerġika.
English: MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 11% (3-25) (study V87P1) to 30% (24-37) (study V87P13) and seroconversion rate of 25% (19-31) for study V87P13.
Maltese: MN għall-istudji kliniċi fit-Tabella hawn fuq urew rata ta' seroprotezzjoni kontra A/turkey/Turkey/05 li tvarja minn 11% (3-25) (studju V87P1) sa 30% (24-37) (studju V87P13) u rata ta' serokonverżjoni ta' 25% (19-31) għall-istudju V87P13.
English: It should be noted that the adverse reactions may be intensified.
Maltese: Ta' min jinnota li r-reazzjonijiet avversi jistgħu jintensifikaw.
English: Adverse reactions from clinical trial in children aged 6 months to 17 years
Maltese: Reazzjonijiet avversi minn provi kliniċi fuq tfal minn 6 xhur sa 17-il sena
English: Serologic responses obtained with the HI assay showed that 92% of subjects achieved seroprotection and 75% seroconverted after two 7.5 µg injections.
Maltese: Risponsi seroloġiċi miksuba bl-assaġġ ta' HI wera li 92% tal-individwi kisbu seroprotezzjoni u 75% ġew serokonvertiti wara żewġ injezzjonijiet ta' 7.5 µg.
English: MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
Maltese: MN kontra A/Vjetnam/1194/2004 jindikaw rata ta' seroprotezzjoni u ta' serokonverżjoni li tvarja minn 57% (50-64) sa 79% (68-87) u minn 55% (48-62) sa 58% (47-69) rispettivament.
English: Immunogenicity was assessed in a subset (n=197) of the study population.
Maltese: L-immunoġeniċità kienet evalwata f'sottosett (n=197) tal-popolazzjoni tal-istudju.
English: Nervous system disorders Common (>1/100, <1/10): headache
Maltese: Disturbi fis-sistema nervuża Komuni (>1/100, <1/10): uġigħ ta' ras
English: In another clinical trial (Phase III) (Study V87P13), 2693 healthy adults were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart.
Maltese: Fi prova klinika oħra (Fażi III) (Studju V87P13), ġew irreġistrati 2693 adult b'saħħithom u rċivew żewġ dożi ta' tilqima li kien fiha H5N1 (A/Vjetnam/1194/2004; 7.5 µg HA/doża adjuvanted) li ngħataw f'intervall ta' tliet ġimgħat.
English: 5.0 ml in 10-dose vial (type I glass) with stopper (halo-butyl rubber).
Maltese: 5.0 ml f'kunjett ta' 10 dożi (ħġieġ ta' tip I) b'għatu (lastku tal-halo-butyl).
English: MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 27% (17-39) (V87P1) to 39% (32-46) (V87P13) and seroconversion rate of 36% (29-43) for study V87P13.
Maltese: MN għall-istudji kliniċi fit-Tabella hawn fuq urew rata ta' seroprotezzjoni kontra A/turkey/Turkey/05 li kienet tvarja minn 27% (17-39) (V87P1) sa 39% (32-46) (V87P13) u rata ta' serokonverżjoni ta' 36% (29-43) għall-istudju V87P13.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)
Maltese: Żewġ dożi tat-tilqima li kien fihom H5N1 (A/Vjetnam/1194/2004;
English: H5N1 adjuvanted vaccine
Maltese: Tilqima adjuvanted H5N1
English: Common (>1/100, <1/10): headache
Maltese: Komuni (>1/100, <1/10): tagħriq
English: One dose (0.5 ml) contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilised hen's eggs from healthy chicken flocks, and adjuvanted with MF59C.1, of strain:
Maltese: Doża waħda (0.5 ml) fiha: Sustanzi Attivi: antiġeni tal-wiċċ tal-virus tal-influwenza (haemagglutinin u euraminidase), ippropagati fil-bajd fertilizzat tat-tiġieġ minn qatgħat ta' tiġieġ b'saħħithom, u adjuvanted b'MF59C.1, tar-razza:
English: The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).
Maltese: L-ingredjenti attivi tat-tilqima huma proteini virali ppurifikati (imsejħa haemagglutinin u neraminidase).
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome.
Maltese: Mard newroloġiku bħal enċefalomajelite (infjammazzjoni tas-sistema nervuża ċentrali), nevrite (infjammazzjoni tan-nervi) u ip ta' paraliżi magħrufa bħala s-Sindrome ta' Guillain-Barré.
English: Two doses of vaccine containing H9N2 (A/chicken/Hong Kong/G9/97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/dose), were administered four weeks apart.
Maltese: Żewġ dożi tat-tilqima bir-razza H9N2 (A/tiġieġ/Hong Kong/G9/97) f'erba' dożaġġi differenti (3.75, 7.5, 15 u 30 μg HA/doża) ingħataw f'intervall ta' erba' ġimgħat.
English: • Frequency of submission:
Maltese: • Frekwenza tas-sottomissjoni:
English: MicroNeutralization (MN) results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Maltese: Ir-riżultati MicroNeutralization (MN) kontra A/Vjetnam/1194/2004 jindikaw rata ta' seroprotezzjoni u ta' serokonverżjoni li tvarja minn 67% (60-74) sa 85% (78-90) u minn 65% (58-72) sa 83% (77-89), rispettivament.
English: Safety data after the first and second dose in children and adolescents with a similar pandemic vaccine (Focetria H1N1v) suggest a comparable safety profile with that reported for the aH5N1 pandemic preparedness vaccine formulation (Foclivia).
Maltese: Id-dejta dwar is-sigurtà wara l-ewwel u t-tieni doża fit-tfal u adolexxenti b'tilqima pandemika simili (Focetria H1N1v) tissuġġerixxi profil tas-sigurtà komparabbli ma' dak irrappurtat għall-formulazzjoni tat-tilqima ta' tħejjija kontra aH5N1 pandemiku (Foclivia).
English: 5 ml vial containing 10 doses (0.5 ml/dose)
Maltese: Kunjett ta' 5 ml li fih 10 dożi (0.5 ml/doża)
English: One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
Maltese: Doża waħda (0.5 ml) tat-tilqima fiha mill-anqas 7.5 mikrogrammi ta' haemagglutinin mir-razzarakkomandata li ġejja ta' virus tal-influwenza:
English: Two doses of vaccine with H5N3 (A/Duck/Singapore/97) strain at 3 different dosages (7.5, 15 and 30 µg HA/dose) were administered three weeks apart.
Maltese: Ingħataw żewġ dożi tat-tilqima bir-razza tal-H5N3 (A/Duck/Singapore/97) fi tliet dożaġġi differenti (7.5, 15 u 30 µg HA/doża) f'intervall ta' tliet ġimgħat.
English: Study V87P13 21 days after 2nd dose N=207
Maltese: Studju V87P13 21 ġurnata wara t-tieni doża N=207
English: A clinical trial (study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 471 children from 6 months to 17 years of age.
Maltese: Saret prova klinika (studju V87P6) bit-tilqima tal-H5N1 ikkombinata ma' adjuvant MF59C.1 fuq 471 tifel u tifla li kellhom minn 6 xhur sa 17-il sena.
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 tilqima kontra l-influwenza, riżultati pożittivi-foloz tat-testijiet seroloġiċi jistgħu jinkisbu permezz tal-metodu ELISA għal antikorpi għall-virus-1 tal-immunodefiċjenza umana (HIV-1), il-virus tal-epatite Ċ u, speċjalment, HTLV-1.
English: Fertility No fertility data are available.
Maltese: Fertilità L-ebda dejta dwar il-fertilità mhi disponibbli.
English: Foclivia is a milky-white liquid.
Maltese: Foclivia huwa likwidu abjad lewn il-ħalib.
English: Of these subjects, 3618 subjects received the pandemic preparedness vaccine Foclivia (A/H5N1) (see section 5.1).
Maltese: Minn dawn l-individwi, 3618-il individwu rċivew it-tilqima ta' tħejjija għal pandemija Foclivia (A/H5N1) (ara sezzjoni 5.1).
English: Serologic responses obtained with the SRH assay showed that 100% of subjects achieved seroprotection and 100% seroconverted after two 7.5 µg injections.
Maltese: Risponsi seroloġiċi miksuba minn assaġġ SRH urew li 100% tal-individwi kisbu seroprotezzjoni u 100% ġew serokonvertiti wara żewġ injezzjonijiet ta' 7.5 µg.
English: After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below*.
Maltese: Tliet ġimgħat wara t-tieni tilqima (jum 43) il-gruppi kollha ta' etajiet (jiġifieri 6-35 xahar, 3-8 snin u 9-17-il sena) kisbu livelli għoljin ta' antikorpi għal (A/Vjetnam/1194/2004) kif evalwati permezz ta' assaġġi SRH u HI kif ippreżentati fit-tabella hawn taħt*.