qanastek/EMEA-V3 huggingface dataset:
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv4 (dated April 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġjar tar- Riskju L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza l- oħra dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni RMPv4 (bid- data ta ’ April 2008) tal- Pjan ta ’ l - Immaniġġjar tar- Riskju (RMP) ppreżentata fit- Taqsima 1. 8. 2. ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ xi aġġornamenti sussegwenti oħra ta ’ l- RMP miftehmin mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskju għall- prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jiġi pprovdut fl- istess żmien tar- Rapporti Perjodikament Aġġornati dwar is- Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, RMP aġġornat għandu jkun sottomess • Meta tkun irċevuta informazzjoni ġdida li tistà tagħmel impatt fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskju. • Fi żmien 60 ġurnata minn meta tkun intlaħqet mira importanti (farmakoviġilanza jew tnaqqis ta ’ riskju) • Fuq talba ta ’ l- EMEA
PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
Sottomissjoni ta ’ PSUR meta Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg jintuża waqt influwenza pandemika:
During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/ 2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
F’ sitwazzjoni pandemika, il- frekwenza tas- sottomissjoni ta ’ rapporti perjodikament aġġornati dwar sigurta` speċifikata fl- Artikolu 24 tar- Regolament (KE) Nru 726/ 2004 ma tkunx biżżejjed għall - monitoraġġ tas- sigurta` ta ’ vaċċin pandemiku li dwaru huma mistennija livelli għolja ta ’ esponiment fi żmien qasir.
Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Sitwazzjoni bħal din titlob notifikazzjoni mgħaġġla dwar informazzjoni ta ’ sigurta` li jista ’ jkollha implikazzjonijiet kbar f’ dak li hu bilanċ ta ’ riskju - benefiċċju waqt influwenza pandemika.
Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Analiżi fil- pront ta ’ informazzjoni dwar sigurta` li tkun inġabret, fid- dawl tat- tul ta ’ l- esponiment, tkun kruċjali għal deċiżjonijiet regolatorji u l - protezzjoni tal- popolazzjoni li trid tiġi vaċċinata.
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Barra dan, sakemm iddum l- influwenza pandemika, riżorsi meħtieġa għal evalwazzjoni fil- fond ta ’ Rapporti Perjodikament Aġġornati dwar Sigurta` fil- forma mfissra fil- Volum 9a tar- Regoli dwar Prodotti Mediċinali fl- Unjoni Ewropea jistgħu ma jkunux biżżejjed għall- identifikazzjoni fil- pront ta ’ xi aspett ġdid ta ’ sigurta`.
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the prepandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
Bħala konsegwenza, hekk kif l- influwenza pandemika tkun dikjarata (Fażi 6 tal- pjan tal- WHO dwar tħejjija għal Influwenza globali) u l- vaċċin pandemiku jkun intuża, l- MAH għandu jibgħat rapporti perjodikament aġġornati dwar sigurta` f’ perijodi u forma kif imfissra hawn taħt:
Frequency of submission
Kemm jintbagħtu spiss:
influenza pandemic (Phase 6 of the WHO Preparedness Plan) (Day 0)
Il- ħin jibda għaddej mill- ewwel nhar ta ’ Tnejn tal- ġimgħa wara d- data li tiġi annunċjata l - influwenza pandemika (Fasi 6 tal- Pjan tal- WHO dwar Tħejjija) (Jum 0) L- ewwel data- lock point ikun 14- il jum wara.
- Report submission is no later than day 22 (i. e. the following Monday).
Ir- rapport jintbgħat mhux aktar tard mit- 22 jum (i. e. it- Tnejn ta ’ wara).
- Reporting to be fortnightly for the first 3 months of the pandemic.
Ir- rapporti jsiru kull ġimagħtejn fl- ewwel 3 xhur ta ’ l- influwenza pandemika.
- Periodicity will be reviewed by the MAH and the (Co-)Rapporteur at 3 monthly
Il- perijodi li fihom għandhom jintbagħtu r- rapporti jiġu riveduti mill- MAH u l - (Co -) Rapporteur kull 3 xhur.
Format The report shall include the following Tables of aggregate data using the agreed templates:
Forma Ir- rapport għandu jnkludi fih it- Tabelli li ġejjin dwar l- informazzjoni globali bl- użu tal- mudelli miftehma:
Fatal and/ or life-threatening reactions – for each Preferred Term (PT), including the proportion of fatal reports 2.
Reazzjonijiet fatali u/ jew li jipperikolaw il- ħajja – għal kull terminu ppreferut (PT), inkluż il- proporzjon ta ’ rapporti fatali 2.
Adverse Events of Special Interest (PTs) 3.
Effetti Avversi ta ’ Interess Speċjali (PTs) 3.
Serious unexpected reactions (PTs) 4.
Reazzjonijiet serji mhux mistennija (PTs) 4.
All events occurring in the following age groups:
Kull ma jkun ġara fil- gruppi ta ’ etajiet li ġejjin:
A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.
Deskrizzjoni globali ta ’ kull ma jkun ġie rappurtat waqt il- perijodu, klassifikat skond it- tip ta ’ min jirrapporta (pazjent jew professjonista fil- kura tas- saħħa), serjeta` tal- każ, kemm kien mistenni, u jekk ikunx volontarju jew mitlub.
Presentation of data will take into consideration the following recommendations:
Fil- preżentazzjoni tat- tagħrif miġbur għandhom jitqiesu r- rakkomandazzjonijiet li ġejjin:
- Serious expected reactions will be reviewed by the MAH as part of their signal
- Reazzjonijiet serji li huma mistennija, jiġu riveduti mill- MAH bħala parti mill -
detection procedures and will only form part of the report if an issue of concern arises.
proċeduri importanti tagħhom dwar dak li jiskopru u jiffurmaw parti mir- rapport biss jekk tinqala ’ xi ħaġa ta ’ tħassib.
- All tables will be based on number of events (presented on PT level, sorted by System
- Kull tabella tkun bażata fuq numru ta ’ affarijiet li jkunu ġraw (preżentati fuq livell ta ’
Organ Class [SOC]) and not number of cases.
PT, u mqassma skond is- Sistema ta ’ l- organi tal- ġisem (SOC) u mhux fuq in- numru ta ’ każi.
- Tables 1 to 4 will be based on events reported from healthcare professionals only.
- It- Tabelli 1 sa 4 ikunu bażati fuq dak li jkun ġie rappurtat biss minn professjonisti fil -
- In Tables 1 to 5, numbers will be provided for events received during the reporting
- Fit- Tabelli 1 sa 5, jingħataw numri għal kull ħaġa rappurtata waqt il- perijodu tar -
period and cumulatively.
rappurtar u skond kif jinġemgħu.
Product-specific
- It- tabelli kollha jkunu bażati fuq tagħrif ġeneriku u li ma jkunx speċifiku għall -
data can be evaluated during signal work-up.
Tagħrif li jkun speċifiku għall- prodott jista ’ jiġi evalwat fix- xogħol ta ’ evalwazzjoni tas- sinjali li għandu jsir.
- No line listings are required – these can be provided in signal evaluation reports as
- Ebda line listings ma huma meħtieġa – dawn jistgħu ikunu disponibbli f’ rapporti ta ’
necessary.
evalwazzjoni tas- sinjali skond il- bżonn.
12 A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (if the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
Sommarju qasir għandu jingħata wkoll mar- rapporti perjodikament aġġornati dwar sigurta`, li fihom kull parti ta ’ tħassib għandha tkun enfasizzata, ix- xogħol ta’ evalwazzjoni tas- sinjali jingħata prijorita` (jekk il- każ ikun ta ’ ħafna sinjali) u ħinijiet xierqa għandhom jingħataw għall - għoti ta ’ rapport sħiħ dwar l- evalwazzjoni ta ’ sinjali.
All signal evaluation reports should be provided, including those that were subsequently not identified as being signals.
Ir- rapporti kollha dwar l- evalwazzjoni ta ’ sinjali għandhom jingħataw, inklużi dawk li sussegwentement ma kienux identifikati bħala sinjali.
A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in:
Għandhom ikunu nklużi sommarju tat- tqassim tal- vaċċin u dettalji dwar in- numru ta ’ dożi tal - vaċċin imqassma fi:
EU member states for the reporting period by batch number, EU member states cumulatively and the rest of the world
Stati Membri ta ’ l- EU dwar il- perijodu ta ’ rappurtar bin- numru tal- lott, Stati Membri ta ’ l- EU b’ mod kumulattiv u
PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION
PAKKETT LI FIH PAKKETT 1 TA ’ 50 KUNJETT TA ’ SUSPENSJONI U 2 PAKKETTI TA ’ 25 KUNJETT TA ’ EMULSJONI
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat)
Split influenza virus, inactivated, containing antigen equivalent to:
Virus maqsum, mhux attivat ta ’ l- influwenza li jkun fih antiġen ekwivalenti għal:
A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14)
3. 75 mikrogrammi * Razza tixbaħ lil A/ VietNam/ 1194/ 2004 (H5N1) użat (NIBRG- 14)
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams) * haemagglutinin
Is- suppliment AS03 magħmul minn squalene (10. 68 milligrammi), DL- α- tocopherol (11. 86 milligrammi) u polysorbate 80 (4. 85 milligrammi) * emagglutinina
Suspension and emulsion for emulsion for injection
Suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni
50 vials: suspension 25 vials x 2: emulsion
50 kunjett: suspensjoni 25 kunjett x 2: emulsjoni
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml)
Il- volum wara li jitħallat kunjett 1 ta ’ suspensjoni (2. 5ml) ma ’ kunjett 1 ta ’ emulsjoni (2. 5ml) jikkorrispondi għal 10 dożi ta ’ vaċċin (5ml)
1 dose = 0.5 ml
Doża 1 = 0. 5 ml
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA’ KIF U MNEJN JINGĦATA
Intramuscular use Shake before use Read the package leaflet before use
Użu għal ġol- muskolu Ħawwad qabel l- użu Aqra l- fuljett ta ’ tagħrif qabel l- użu
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IET) SPEĊJALI OĦRA JEKK MEĦTIEĠA
Suspension and emulsion to be mixed before administration
Is- suspensjoni u l- emulsjoni għandhom jitħalltu qabel jingħataw
Rue de l’ Institut 89 B-1330 Rixensart, Belgium
Rue de l’ Institut 89 B- 1330 Rixensart, Il- Belġju
Justification for not including Braille accepted
Il- ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata.
PACK OF 50 VIALS OF SUSPENSION
PAKKETT TA ’ 50 KUNJETT TA ’ SUSPENSJONI
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection Prepandemic influenza vaccine (H5N1)
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg suspensjoni għal emulsjoni għall- injezzjoni Vaċċin għal influwenza prepandemika (H5N1)
Split influenza virus, inactivated, containing antigen equivalent to A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14) * haemagglutinin
Virus maqsum, mhux attivat ta ’ l- influwenza li jkun fih antiġen ekwivalenti għal razza tixbaħ lil 3. 75 mikrogrammi * A/ VietNam/ 1194/ 2004 (H5N1) użat (NIBRG- 14) * emagglutinina
Suspension for emulsion for injection 50 vials: suspension
Suspensjoni għal emulsjoni għall- injezzjoni 50 kunjett: suspensjoni
Suspension to be exclusively mixed with emulsion before administration
Suspensjoni li għandha titħallat esklussivament ma ’ emulsjoni qabel tingħata
Dispose of in accordance with local regulations.
Armi skond ir- regolamenti lokali.
PACK OF 25 VIALS OF EMULSION
PAKKETT TA ’ 25 KUNJETT TA ’ EMULSJONI
Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Emulsjoni għal emulsjoni għall- injezzjoni għal Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams)
Is- Suppliment AS03 magħmul minn squalene (10. 68 milligrammi), DL- α- tocopherol (11. 86 milligrammi) u polysorbate 80 (4. 85 milligrammi)
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Ilma għall- injezzjonijiet
Emulsion for emulsion for injection 25 vials: emulsion
Emulsjoni għal emulsjoni għall- injezzjoni 25 kunjett: emulsjoni
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA’ KIF U MNEJN
Emulsion to be exclusively mixed with suspension before administration
Emulsjoni li għandha titħallat esklussivament ma ’ suspensjoni qabel tingħata
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
22 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN KUNJETT TA ’ SUSPENSJONI
Vial A Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection IM
Kunjett A Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg suspensjoni għal emulsjoni għall- injezzjoni IM
To be mixed with Vial B before administration
Għandu jitħallat ma ’ Kunjett B qabel jingħata
EXP After mixing:
JIS Wara li jitħallat:
Use within 24 hours and do not store above 25°C.
Użah fi żmien 24 siegħa u taħżnux f’ temperatura ‘ l fuq minn 25°C.
Date and time of mixing:
Data u ħin meta tħallat:
10 doses (2.5 ml)
10 dożi (2. 5 ml)
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS EMULSION VIAL
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN KUNJETT TA ’ EMULSJONI
Vial B Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg IM
Kunjett B Emulsjoni għal emulsjoni għall- injezzjoni għal Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg
To be mixed with Vial A before administration
Għandu jitħallat ma ’ Kunjett A qabel jingħata.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni Vaċċin ta ’ l- influwanza prepandemika (H5N1) (virjon maqsum, inattivat, supplimentat)
Read all of this leaflet carefully before you start receiving this vaccine.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for 2.
X’ inhu Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg u għalxiex jintuża 2.
Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 3.
Qabel ma tieħu Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg 3.
How Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is given 4.
Kif għandek tieħu Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg 4.
How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 6.
Kif taħżen Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg 6.
WHAT PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg IS AND WHAT IT IS USED FOR
X’ INHU VAĊĊIN GĦAL INFLUWENZA PREPANDEMIKA (H5N1) (VIRJON MAQSUM, MHUX ATTIVAT, SUPPLIMENTAT) GLAXOSMITHKLINE BIOLOGICALS 3. 75 µG U GĦALXIEX JINTUŻA
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is a vaccine for use in adults from 18 to 60 years old.
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg huwa vaċċin għall- użu fl- adulti ta ’ età minn 18 sa 60 sena.
It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
L - intenzjoni hija li jingħata qabel jew waqt il- pandemija ta 'l- influwenza li jmiss biex jilqa ’ kontra l - influwenza kkawżata mit- tip H5N1 tal- virus.
Pandemic flu is a type of influenza that occurs at intervals that vary from less than 10 years to many decades.
L- influwenza pandemika hija tip ta ’ influwenza li iseħħ f’ intervalli li jvarjaw minn taħt għaxar snin għal ħafna għexiren ta ’ snin.
It spreads rapidly around the world.
Tinfirex malajr madwar id- dinja.
The symptoms of pandemic flu are similar to those of ordinary flu but are usually more severe.
Is- sintomi ta ’ l- influwenza pandemika huma simili għal dawk ta ’ l- influwenza normali imma ġeneralment ikunu aktar severi.
When a person is given the vaccine, the immune system (the body’ s natural defence system) will produce its own protection (antibodies) against the disease.
Meta persuna tingħata l- vaċċin, is- sistema immuni (is- sistema ta ’ difiża naturali tal- ġisem) tipproduċi protezzjoni għaliha nnifisha (antikorpi) kontra l- marda.
None of the ingredients in the vaccine can cause flu.
L- ebda wieħed mill- ingredjenti tal- vaċċin ma jista ’ jikkawża l- influwenza.
As with all vaccines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg may not fully protect all persons who are vaccinated.
Bħal vaċċini l- oħra kollha, Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg jista ’ ma jipproteġix kompletament lill - persuni kollha li jkunu mlaqqma.
BEFORE YOU RECEIVE PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg
QABEL MA TIEĦU VAĊĊIN GĦAL INFLUWENZA PREPANDEMIKA (H5N1) (VIRJON MAQSUM, MHUX ATTIVAT, SUPPLIMENTAT) GLAXOSMITHKLINE BIOLOGICALS 3. 75 µG
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should not be given:
Tieħux Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg:
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (these are listed at the end of this leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde,
• jekk xi darba kellek reazzjoni allerġika f’ daqqa waħda li tkun ta ’ periklu għal- ħajja għal kwalunkwe ingredjent ta ’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux
26 gentamicin sulphate (antibiotic) or sodium deoxycholate.
26 attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg (dawn huma mniżżla fl- aħħar ta ’ dan il- fuljett), jew għal xi wieħed mis- sustanzi li jista ’ jkun fih f’ ammonti żgħar ħafna: proteini tal- bajd jew tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate (antibiotiku) jew sodium deoxycholate.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Sinjali ta ’ reazzjoni allerġika jistgħu jinkludu raxx tal- ġilda b’ ħakk, qtugħ ta ’ nifs u nefħa fil- wiċċ jew fl- ilsien.
• if you have a severe infection with a high temperature (over 38°C).
• jekk għandek infezzjoni severa b’ deni għoli (’ l fuq minn 38°C).
If this applies to you then your vaccination will be postponed until you are feeling better.
Jekk dan japplika għalik it - tilqim tiegħek jiġi pospost sakemm tkun qed tħossok aħjar.
A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Infezzjoni ħafifa bħal riħ m’ għandiex tkun problema, iżda t- tabib tiegħek jagħtik parir jekk inti tistax xorta waħda titlaqqam b' Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg.
Take special care with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
Oqgħod attent ħafna b' Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg:
• if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
• jekk qatt kellek reazzjoni allerġika minbarra reazzjoni allerġika f’ daqqa waħda li tkun ta ’ periklu għall- ħajja għal kwalunkwe ingredjent li fih il- vaċċin, għal thiomersal, għal proteini tal - bajd u tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate (antibiotiku) jew għal sodium deoxycholate.
(see section 6.
(ara sezzjoni 6.
Further information). • if you have problems with your immune system, since your response to the vaccine may then be poor. • if you are having a blood test to look for evidence of infection with certain viruses.
Aktar informazzjoni) • jekk għandek problema bis- sistema immuni, peress li minħabba f’ hekk ir- respons tiegħek għal - vaċċin jista ’ jkun batut. • Jekk qed tagħmel xi test tad- demm biex issib evidenza ta ’ infezzjoni b’ ċerti tipi ta ’ virus.
In the first few weeks after vaccination with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg the results of these tests may not be correct.
Fl - ewwel ftit ġimgħat wara t- tilqim b’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg, ir- riżultati ta ’ dawn it- testijiet jistgħu ma jkunux tajba.
Tell the doctor requesting these tests that you have recently received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Għid lit- tabib li qed jordnalek dawn it- testijiet li m’ ilekx li ħadt Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg.
Using other medicines or vaccines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Meta tieħu mediċini jew vaċċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk tkun qed tieħu jew reċentement tkun ħadt xi mediċini oħra, inklużi mediċini mingħajr riċetta tat- tabib jew jekk reċentement tkun ħadt xi vaċċin ieħor.
There are no data on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg given at the same time as other vaccines.
M’ hemmx tagħrif dwar l- użu ta ’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg meta jingħata flimkien ma ’ vaċċini oħrajn.
Therefore, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is not intended to be given at the same time as other vaccines.
Għalhekk, Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg m’ huwiex intenzjonat li jingħata fl- istess ħin ma ’ vaċċini oħra.
However, if this cannot be avoided, the other vaccine will be injected into the other arm.
Madankollu, jekk dan ma jistax jiġi evitat, il- vaċċin l- ieħor għandu jiġu injettati fid - driegħ l- ieħor.
Any side effects that occur may be more severe.
Kwalunkwe effett sekondarju li jiġri jista ’ jkun aktar serju.
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can still be given but your response to the vaccine may be poor.
Jekk tieħu xi mediċini li jnaqqsu l- immunita` għall- infezzjonijiet jew jekk tkun tieħu xi tip ta ’ kura oħra (bħal radjoterapija) li taffettwa s- sistema immuni, Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg xorta jista ’ jingħata iżda r- respos tiegħek għall- vaċċin jista ’ jkun batut.
Pregnancy and breast-feeding There is no information on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in pregnant or breast-feeding women.
Tqala u Treddigħ M’ hemmx informazzjoni dwar l- użu ta ’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg f’ nisa tqal jew li qed ireddgħu.
Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breast- feeding.
It- tabib tiegħek għandu jagħmel stima tal- benefiċċji u r- riskji kieku kellu jagħtik il- vaċċin waqt li inti tqila jew qed treddgħa.
Please tell your doctor if you are/ may be pregnant or intend to become pregnant, or if you are breast-feeding and follow his advice.
Jekk jogħġbok għid lit- tabib tiegħek jekk inti / tista ’ tkun tqila jew qed taħseb biex issir tqila, jew jekk qed tredda ’ u oqogħod fuq il- parir tiegħu.
Driving and using machines Some effects mentioned under section 4. “ Possible side effects” may affect the ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Xi effetti msemmija taħt sezzjoni 4. “ Effetti sekondarji li jista ’ jkollu ” jistgħu jaffettwaw il- ħila li ssuq jew tħaddem magni.
Important information about some of the ingredients of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg Thiomersal (preservative) is present in this product, and it is possible that you may experience an allergic reaction.
Tagħrif importanti dwar xi wħud mill- ingredjenti ta ’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg
27 This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i. e. essentially sodium- and potassium-free.
Dan il- prodott mediċinali fih anqas minn 1mmol ta ’ sodium (23 mg) u anqas minn 1 mmol ta ’ potassium (39 mg) f’ kull doża, i. e. essenzjalment huwa mingħajr sodium u potassium.
HOW PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg IS GIVEN
KIF GHANDEK TIEHU VACCIN GHAL INFLUWENZA PREPANDEMIKA (H5N1) (VIRJON MAQSUM, MHUX ATTIVAT, SUPPLIMENTAT) GLAXOSMITHKLINE BIOLOGICALS 3. 75 µG
You will receive two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Inti se tirċievi żewġ dożi ta ’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg.
The second dose should be given after an interval of at least three weeks.
It- tieni doża għandha tingħata wara intervall ta ’ mill- anqas tliet ġimgħat.
The doctor or nurse will give Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg as an injection into your upper arm muscle.
It- tabib jew l- infermier jagħti Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg bħala injezzjoni fil- muskolu tan- naħa ta ’ fuq tad- driegħ.
The vaccine should never be given into a vein or into the skin.
Il- vaċċin m’ għandu qatt jingħata ġol- vina jew ġol- ġilda.
If you have any further questions on the use of this product, ask your doctor or nurse.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- infermier tiegħek.
Like all medicines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
♦ Very common (these may occur with 1 in 10 doses or more of the vaccine): • Tiredness • Headache • Pain, redness, swelling or a hard lump at the injection site • Fever • Aching muscles, joint pain
♦ Komuni ħafna (dawn jistgħu jseħħu b’ doża 1 minn kull 10 dożi jew aktar tal- vaċċin): • Għeja • Uġigħ ta ’ ras • Uġigħ, ħmura, nefħa jew għoqda iebsa fis- sit ta ’ l- injezzjoni • Deni • Uġigħ fil- muskoli, uġigħ fil- ġogi
♦ Common (these may occur with up to 1 in 10 doses of the vaccine): • Warmth, itching or bruising at the injection site • Increased sweating, shivering, flu-like symptoms • Swollen glands in the neck, armpit or groin
♦ Komuni (dawn jistgħu jseħħu b’ sa doża 1 minn kull 10 dożi tal- vaċċin): • Sħana, ħakk u tbenġil fis- sit ta ’ l- injezzjoni • Żieda fil- ħruġ ta ’ l- għaraq, tregħid, sintomi bħal ta ’ l- influwenza • Glandoli minfuħin fl- għonq, fl- abt jew fil- parti irqiqa ta ’ bejn il- koxxa u ż- żaqq
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Tingling or numbness of the hands or feet • Dizziness • Sleepiness • Sleeplessness • Diarrhoea, vomiting, stomach pain, feeling sick • Itching, rash • Generally feeling unwell
♦ Mhux komuni (dawn jistgħu jseħħu b’ sa doża 1 minn kull 100 doża tal- vaċċin): • Tnemnim fl- idejn u fis- saqajn jew idejn u saqajn imtarrxin • Sturdament • Ngħas • Nuqqas ta ’ rqad • Dijarea, rimettar, uġigħ fl- istonku, dardir • Ħakk, raxx • Tħossok ma tiflaħx b’ mod ġenerali
These reactions usually disappear within 1-2 days without treatment.
Dawn ir- reazzjonijiet ġeneralment imorru fi żmien ġurnata jew jumejn mingħajr kura.
Other side effects which have occurred in the days or weeks after vaccination with ordinary flu vaccines include:
Effetti sekondarji oħra li seħħew fil- ġranet jew ġimgħat ta ’ wara t- tilqim b’ vaċċini komuni ta ’ l - influwenza jinkludu:
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives)
28 ♦ Mhux komuni (dawn jistgħu jseħħu b’ sa doża 1 minn kull 100 doża tal- vaċċin): • Reazzjonijiet mifruxa fil- ġilda li jinkludu l- urtikarja (ħorriqija)
28 • Fits • Low blood platelet count which can result in bleeding or bruising • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death
♦ Rari (dawn jistgħu jseħħu f’ sa doża 1 minn kull 1, 000 doża tal- vaċċin): • Uġigħ qawwi donnu kkawżat minn xi arma bil- ponta jew tektik matul nerv wieħed jew aktar • Aċċessjonijiet • Għadd baxx ta ’ plejtlits fid- demm li jista ’ jwassal għal fsada jew tbenġil • Reazzjonijiet allerġiċi li jwasslu għal waqa ’ perikoluża fil- pressjoni, li jekk ma tiġix ikkurata tista ’ twassal għall- kollass, koma u mewt
♦ Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): • Narrowing or blockage of blood vessels with kidney problems • Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may spread across the body.
♦ Rari ħafna (dawn jistgħu jseħħu f’ sa doża 1 minn kull 10, 000 doża tal- vaċċin): • Djuq jew sadd ta ’ vini jew arterji fejn ikun hemm problemi bil- kliewi • Infjammazzjoni temporanja tal- moħħ u n- nervituri li tikkawza uġigħ, djgħufija u paraliżi li tista ’ tinfirex mal- ġisem.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi effetti sekondarji jiggravaw, jew jekk tinnota xi effetti sekondarji li m’ humiex imniżżla f’ dan il- fuljett, jekk jogħġbok kellem lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg
KIF TAHZEN VACCIN GHAL INFLUWENZA PREPANDEMIKA (H5N1) (VIRJON MAQSUM, MHUX ATTIVAT, SUPPLIMENTAT) GLAXOSMITHKLINE BIOLOGICALS 3. 75 µG
Before the vaccine is mixed:
Qabel ma jitħallat il- vaċċin:
Do not use the suspension and the emulsion after the expiry date which is stated on the carton.
Tużax is- suspensjoni u l- emulsjoni wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2°Ċ - 8°Ċ).
Do not freeze.
Tagħmlux fi friża.
After the vaccine is mixed:
Wara li jitħallat il- vaċċin:
After mixing, use the vaccine within 24 hours and do not store above 25°C.
Wara li jitħallat, uża l- vaċċin fi żmien 24 siegħa u taħżinx f’ temperatura ‘ l fuq minn 25°C.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għanekx bżonn.
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg contains
X’ fih Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg
- Active substance:
- Sustanza attiva:
After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain:
Wara li jitħallat, doża waħda (0. 5 ml) ikun fiha 3. 75 mikrogrammi ta ’ emagglutinina mir- razza tal- virus ta ’ l- influwenza li ġej:
- Adjuvant:
- Suppliment:
The emulsion vial contains an ‘ adjuvant’ (AS03).
Il- kunjett ta ’ l- emulsjoni fih ‘ suppliment ’ (AS03).
This compound contains squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams).
Dan il- kompost fih squalene (10. 68 milligrammi), DL- α- tocopherol (11. 86 milligrammi) u polysorbate 80 (4. 85 milligrammi).
Adjuvants are used to improve the body’ s response to the vaccine.
Is - supplimenti jintużaw biex itejbu r- respons tal- ġisem għal vaċċin.
- Other ingredients:
- Ingredjenti oħra:
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl), disodium hydrogen phosphate (Na2HPO4), potassium dihydrogen phosphate(KH2PO4), potassium chloride (KCl), magnesium chloride (MgCl2), water for injections
L- ingredjenti l- oħra huma: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl), disodium hydrogen phosphate (Na2HPO4), potassium dihydrogen phosphate (KH2PO4), potassium chloride (KCl), magnesium chloride (MgCl2), ilma għall- injezzjonijiet.
29 What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg looks like and contents of the pack
Id- dehra ta ’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg u l- kontenuti tal- pakkett
One pack of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of:
Pakkett wieħed ta ’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg fih:
- one pack containing 50 vials of 2.5 ml suspension (active substance) for 10 doses
- pakkett wieħed li fih 50 kunjett ta ’ 2. 5 ml suspensjoni (sustanza attiva) għal 10 dożi
- two packs containing 25 vials of 2.5 ml emulsion (adjuvant) for 10 doses
- żewġ pakketti li fihom 25 kunjett ta ’ 2. 5 ml emulsjoni (suppliment) għal 10 dożi
Prior to administration, the two components should be mixed.
Qabel ma ’ jingħataw, iż- żewg komponenti għandhom jitħalltu.
Rue de l’ Institut 89 B-1330 Rixensart Belgium
Rue de l’ Institut 89 B- 1330 Rixensart Il- Belġju
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżenttant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/ ---------------------------------------------------------------------------------------------------------------------
31 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu / ---------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku jew fil- kura tas- saħħa:
Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Kunjett A: kunjett b’ ħafna dożi li fih l- antiġen (suspensjoni) Kunjett B: kunjett b’ ħafna dożi li fih is- suppliment (emulsjoni).
What is HBVAXPRO?
X’ inhu HBVAXPRO?
HBVAXPRO is a vaccine, which is available as a suspension for injection in vials and pre-filled syringes.
HBVAXPRO huwa vaċċin, li jiġi bħala sospensjoni għall- injezzjoni fi fjali u f’ siringi mimlija minn qabel.
It contains parts of the hepatitis B virus as the active substance.
Fih partijiet mill- virus ta ’ l- epatite B bħala s- sustanza attiva.
HBVAXPRO is available in two strengths (10 and 40 micrograms/ ml).
HBVAXPRO jiġi f’ żewġ konċentrazzjonijiet (10 u 40 mikrogramma/ ml).
What is HBVAXPRO used for?
Għalxiex jintuża HBVAXPRO?
HBVAXPRO is used to vaccinate against hepatitis B in people who are at risk of exposure to the hepatitis B virus, as determined on the basis of official recommendations.
HBVAXPRO jintuża fit- tilqim kontra l- epatite B f’ persuni b’ riskju li jkunu esposti għall- virus ta ’ l - epatite B, abbażi tar- rakkomandazzjonjiet uffiċjali.
How is HBVAXPRO used?
Kif jintuża HBVAXPRO?
A course of vaccination should include at least three injections of HBVAXPRO.
Il- kors tat- tilqim għandu jkun fih ta ’ l- anqas tliet injezzjonjiet ta ’ HBVAXPRO.
The recommended dose for children up to the age of 15 years is 0.5 ml of the lower strength (10 micrograms/ ml) at each injection.
Id- doża rakkomandata għat- tfal sa l- età ta ’ 15- il sena hi 0. 5 ml tal- prodott bil- konċentrazzjoni baxxa (10 mikrogrammi/ ml) f’ kull injezzjoni.
For adults and adolescents aged 16 years of age and older, 1 ml of the lower strength is given at each injection.
Għall- adulti u l- adoloxxenti ta ’ 16- il sena jew iktar, jingħata 1 ml tal- konċentrazzjoni baxxa f’ kull injezzjoni.
The higher strength (40 micrograms/ ml) is used in patients who are undergoing or are about to undergo dialysis (a blood clearance technique).
Il- konċentrazzjoni għolja (40 mikrogramma/ ml) tintuża f’ pazjenti li tkun qed issirilhom dialiżi (teknika għat- tisfija tad- demm).
HBVAXPRO is usually given as an injection into the muscle of the thigh in babies and infants, and of the shoulder in children, adolescents and adults.
HBVAXPRO ġeneralment jingħata bħala injezzjoni fil- muskolu tal- koxxa fit- trabi u t- tfal żgħar, u fil - muskolu ta ’ l- ispalla fit- tfal, l- adoloxxenti u l- adulti.
The timing of injections depends on the patient ’ s age, strength of the immune system, response to vaccination and likelihood of exposure to the hepatitis B virus.
Iż- żmien ta ’ meta jingħataw l- injezzjonijiet jiddependi mill- età tal- pazjent, mis- saħħa tas- sistema immunitarja, mir- rispons għat- tilqima u mill- probabilità li l- persuna tkun esposta għall- virus ta ’ l - epatite B.
How does HBVAXPRO work?
Kif jaħdem HBVAXPRO?
HBVAXPRO is a vaccine.
HBVAXPRO huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiża naturali tal- ġisem) kif tiddefendi ruħha kontra marda.
HBVAXPRO contains small amounts of ‘ surface antigens ’ (proteins from the surface) of the hepatitis B virus.
HBVAXPRO fih ammonti żgħar ta ’ ‘ antiġeni tal- wiċċ ’ (proteini mis- superfiċje) tal- virus ta ’ l- epatite B.
When a person is given the vaccine, the immune system recognises the surface antigens as ‘ foreign’ and makes antibodies against them.
Meta persuna tingħata l- vaċċin, is- sistema immunitarja tagħraf lill- antiġeni bħala ‘ barranin ’ u tagħmel antikorpi kontrihom.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the viruses.
Imbagħad, is- sistema immunitarja tkun tista ’ tipproduċi antikorpi iktar malajr meta l- persuna tiġi esposta għall- virus b’ mod naturali.
This helps to protect against infection with the hepatitis B virus.
Dan jgħin fil- protezzjoni kontra l- infezzjoni bil- virus ta ’ l- epatite B.
The surface antigens in HBVAXPRO are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce
L- antiġeni tal- wiċċ f’ HBVAXPRO jiġu prodotti b’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: jiġu ffurmati minn ħmira li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l -
Reproduction is authorised provided the source is acknowledged. the proteins.
Reproduction is authorised provided the source is acknowledged. proteini.
The surface antigens are also ‘ adsorbed’.
L- antiġeni tal- wiċċ jiġu wkoll ‘ adsorbiti ’.
This means that they are fixed onto aluminium compounds to help stimulate a better response.
Dan ifisser li dawn jeħlu fuq komposti ta ’ l - aluminju biex jiġi stimulat rispons aħjar.
HBVAXPRO was specifically developed from a vaccine that was already in use in the European Union (EU), in order to remove the preservative thiomersal, which contains mercury.
HBVAXPRO ġie speċifikatament żviluppat minn tilqima li diġà kienet qegħda tintuża fl- Unjoni Ewropea (UE), biex jitneħħa l- preservattiv thiomersal, li fih il- merkurju.
Repeated exposure to mercury from sources such as medicines and foods could lead to it building up in the organs.
Meta wieħed ikun ripetutament espost għall- merkurju minn sorsi bħall- mediċini u l- ikel, dan jista ’ jwassal għal akkumulazzjoni fl- organi.
This build-up could be dangerous and is a cause of concern.
Din l- akkumulazzjoni tista ’ tkun perikoluża u ta ’ inkwiet.
How has HBVAXPRO been studied?
Kif ġie studjat HBVAXPRO?
Because the active substance used in HBVAXPRO was already authorised for use in the EU, there have been no formal studies of HBVAXPRO.
Billi s- sustanza attiva użata f’ HBVAXPRO diġà kienet awtorizzata għall- użu fl- UE, ma kienx hemm studji formali dwar HBVAXPRO.
The company provided information comparing other vaccines with and without thiomersal, including studies of a vaccine that contains the same active substance as HBVAXPRO.
Il- kumpanija pprovdiet tagħrif li jqabbel HBVAXPRO ma ’ tilqimiet oħra bi jew mingħajr thiomersal, inkluż studji ta ’ vaċċin li fih l- istess sustanza attiva bħal HBVAXPRO.
What benefit has HBVAXPRO shown during the studies?
Liema benefiċċju wera HBVAXPRO waqt l- istudji mwettqa?
The results of the studies presented showed that the thiomersal-free vaccines produced protective levels of antibodies against hepatitis B virus to a similar extent to the vaccines that contained thiomersal at the end of the vaccination course.
Ir- riżultati ta ’ l- istudji ppreżentati kkonkludew li l- vaċċini mingħajr thiomersal ipproduċew livelli ta ’ protezzjoni ta ’ antikorpi kontra l- virus ta ’ l- epatite B daqs il- vaċċini li kien fihom thiomersal fi tmiem il- kors ta ’ tilqim.
This included the vaccines that contain the same active substance as HBVAXPRO.
Fost dawn kien hemm vaċċini li fihom l- istess sustanza attiva bħal HBVAXPRO.
What is the risk associated with HBVAXPRO?
X’ inhu r- riskju assoċjat ma ’ HBVAXPRO?
The most common side effects with HBVAXPRO (seen in between 1 and 10 patients in 100) are reactions at the injection site, including temporary soreness, erythema (redness) and induration (hardening).
L- iktar effetti sekondarji komuni ma ’ HBVAXPRO (li dehru f’ bejn pazjent wieħed u għaxra minn kull 100) huma reazzjonijiet fis- sit ta ’ l- injezzjoni, fosthom irritazzjoni, ħmura u ebusija temporanja.
For the full list of side effects reported with HBVAXPRO, see the Package Leaflet.
Għal - lista sħiħa ta ’ l- effetti sekondarji rrappurtati b’ HBVAXPRO, ara l- Fuljett ta ’ Tagħrif.
HBVAXPRO should not be given to people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
HBVAXPRO m’ għandux jingħata lil persuni li jistgħu jkunu allerġiċi għas- sustanzi attivi jew għal xi sustanza oħra tiegħu.
It should not be used in people with a severe fever.
M’ għandux jingħata lil min ikollu ħafna deni.
As for all vaccines, if HBVAXPRO is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Bħat- tilqimiet l- oħra, jekk HBVAXPRO jintuża fi trabi prematuri ħafna, ikun hemm ir- riskju li t- trabi jkollhom waqtiet qosra li matulhom ma jeħdux nifs.
Their breathing should be monitored for up to three days after vaccination.
In- nifs tagħhom għandu jibqa ’ sorveljat sa tlett ijiem wara t- tilqima.
Why has HBVAXPRO been approved?
Għaliex ġie approvat HBVAXPRO?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the removal of thiomersal from vaccines did not reduce their effectiveness in protecting against hepatitis B virus infection, but reduced their risks.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li t- tneħħija ta ’ thiomersal mit- tilqimiet ma naqsitx l- effettività tagħhom fil- protezzjoni kontra l- infezzjoni ta ’ l- epatite B, iżda naqset ir- riskji tagħhom.