qanastek/EMEA-V3 huggingface dataset:
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or hospital pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, l- infermier jew l- ispiżjar ta ’ l- isptar tiegħek.
HOW TO STORE FASTURTEC
KIF TAĦŻEN FASTURTEC
Do not use Fasturtec after the expiry date which is stated on the carton.
Tużax Fasturtec wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Store in a refrigerator (2 °C – 8 °C).
Ahżen fi friġġ (2 °Ċ - 8 °Ċ).
Do not use Fasturtec if you notice that the solution is unclear and/ or contains particles.
Tużax Fasturtec jekk tinnota li s- soluzzjoni mhix ċara u/ jew fiha xi frak.
What Fasturtec contains
X’ fih Fasturtec
- The active substance is rasburicase 1.5 mg/ ml.
- Is- sustanza attiva hi rasburicase 1. 5 mg/ ml.
Rasburicase is produced by genetechnology in a
Rasburicase hija magħmula b ’ teknoloġija ġenetika
microorganism named Saccharomyces cerevisiae.
f’ mikro- organiżmu msemmi Saccharomyces cerevisiae.
- The other ingredients of the powder are: alanine, mannitol, disodium phosphate dodecahydrate,
- Is- sustanzi l- oħra tat- trab huma: alanine, mannitol, disodium phosphate dodecahydrate,
disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
- The other ingredients of the solvent are: poloxamer 188, water for injection.
- Is- sustanzi l- oħra tas- solvent huma: poloxamer 188, ilma għall- injezzjoni.
Fasturtec is provided as a powder and solvent for concentrate for solution for infusion.
Id- Dehra tal- prodott u l- kontenuti tal- pakkett Fasturtec huwa pprovdut bħal trab u solvent għall- konċentrat għal soluzzjoni għall- infużjoni.
The powder is an entire or broken white to off white pellet.
It- trab huwa taht għamla ta ’ pritkuna sħiħa jew miksura ta ’ kulur abjad sa offwajt.
The solvent is a colourless and clear liquid.
Is- solvent huwa likwidu bla kulur u ċar.
Pack of 3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
Pakkett ta ’ 3 kunjetti ta ’ 1. 5 mg rasburicase u 3 ampulli ta ’ 1 ml solvent.
The powder is supplied in 3 ml clear glass vial with a rubber stopper and the solvent in a 2 ml clear glass ampoule.
It- trab huwa fornit f’ kunjett ta ’ 3 ml, ta ’ ħġieġ ċar, b’ tapp tal- lastiku, u s- solvent huwa f’ ampulla ta ’ 2 ml, ta ’ ħġieġ ċar.
Pack of 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
Pakkett ta ’ kunjett 1 ta ’ 7. 5 mg rasburicase u ampulla 1 ta ’ 5 ml solvent.
The powder is supplied in 10 ml clear glass vial with a rubber stopper and the solvent in a 5 ml clear glass ampoule.
It- trab huwa fornit f’ kunjett ta ’ 10 ml, ta ’ ħġieġ ċar, b’ tapp tal- lastiku, u s- solvent huwa f’ ampulla ta ’ 5 ml, ta ’ ħġieġ ċar.
sanofi-aventis 174, avenue de France F-75013 Paris France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq sanofi- aventis 174, avenue de France F- 75013 Paris Franza
Glaxo Wellcome Production 1, rue de l’ Abbaye F-76960 Notre Dame de Bondeville France
25 Manifatturi Glaxo Wellcome Production 1, rue de l’ Abbaye F- 76960 Notre Dame de Bondeville Franza
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- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
26 Ísland Vistor hf.
26 Ísland Vistor hf.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
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--------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
See section 3 “ How to use Fasturtec” and practical information on preparation and handling given below.
Ara sezzjoni 3 “ Kif tuża Fasturtec ” u l- informazzjoni prattika fuq il- preparazzjoni u l- immaniġġar mogħtija hawn taħt.
1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Fasturtec għandu jiġi rikostitwit bil- volum sħiħ tas- solvent fl- ampulla ipprovduta (kunjett ta ’ 1. 5 mg rasburicase għandu jiġi rikostitwit b’ 1 ml tas- solvent ta ’ l- ampulla; kunjett ta ’ 7. 5 mg rasburicase għandu jiġi rikostitwit b’ 5 ml tas- solvent ta ’ l- ampulla).
Reconstitution results in a solution with a concentration of 1.5 mg/ ml to be further diluted with sodium chloride 9 mg/ ml (0.9%).
Ir- rikostituzzjoni tirriżulta f’ soluzzjoni li huwa konċentrat ta ’ 1. 5 mg / ml ta ’ rasburicase, u li għandu jiġi dilwit aktar b’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
Add the content of one ampoule of solvent to one vial containing rasburicase and mix by swirling very gently under controlled and validated aseptic conditions.
Żid il- kontenut ta ’ ampulla waħda ta ’ solvent ma ’ kunjett wiehed li fih rasburicase u ħawwad billi iddawwar il- kontenut tal- kontenitur bil- mod il- mod, taħt kondizzjonijiet asettiċi kkontrollati u validati.
Dilution before infusion:
Is sustanza dilwita qabel l- infużjoni:
The use of several vials may be necessary to obtain the quantity of rasburicase required for one administration.
L- użu ta ’ diversi kunjetti jista ’ jkun neċessarju biex tikseb l- kwantità ta ’ rasburicase meħtieġa għall- għotja waħda.
27 The reconstituted solution contains no preservative.
27 Is- soluzzjoni rikostitwita m’ għandha ebda preservattiv.
Infusion:
L- infużjoni:
Blood must be collected into pre-chilled tubes containing heparin anticoagulant.
Id- demm għandu jitpoġġa f’ tubi, li fihom heparin bħala sustanza kontra l- koagulazzjoni tad- demm, u li dawn iridu jkunu imkesħin qabel ma ’ tibda l- proċedura.
Samples must be immersed in an ice/ water bath.
Il- kampjuni għandhom jitpoġġew f’ banju tal- laboratorju taħt is- silġ/ ilma.
Plasma samples should immediately be prepared by centrifugation in a pre-cooled centrifuge (4 °C).
Il- kampjuni tal- plażma għandhom jiġu ippreparati immedjatament permezz taċ- ċentrifugazzjoni, f’ apparat li jkun imkessaħ minn qabel (4 °Ċ).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta' CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Fendrix?
X' inhu Fendrix?
Fendrix is a vaccine, which is available as a suspension for injection.
Fendrix huwa vaċċin, li jinsab bħala sospensjoni għal injezzjoni.
It contains parts of the hepatitis B virus as the active substance.
Bħala s- sustanza attiva fih partijiet mill- vajrus ta 'l- epatite B.
What is Fendrix used for?
Għal xiex jintuża Fendrix?
Fendrix is used to protect patients with kidney problems against hepatitis B.
Fendrix jintuża biex jipproteġi pazjenti bi problemi tal- kliewi kontra l- epatite B.
It can be used in patients from the age of 15 years, including patients needing haemodialysis (a blood clearance technique).
Jista 'jintuża f' pazjenti mill- età ta' 15- il sena, inklużi pazjenti li jeħtieġu emodijaliżi (teknika ta 'purifikazzjoni tad- demm).
How is Fendrix used?
Kif jintuża Fendrix?
The recommended vaccination schedule for Fendrix is four doses.
Il- programm ta 'tilqim irrakkomandat għal Fendrix huwa ta' erba 'dożi.
There should be a gap of one month between the first and second, and between the second and third injections.
Għandu jkun hemm spazju ta 'żmien ta' xahar bejn l- ewwel u t- tieni, u bejn it- tieni u t- tielet injezzjoni.
The fourth injection is given four months after the third.
Ir- raba 'injezzjoni tingħata erba' xhur wara t- tielet waħda.
It is recommended that individuals who receive the first dose should complete the course with Fendrix.
Huwa rrakkomandat li individwi li jirċievu l- ewwel doża għandhom ikomplu l- kors b' Fendrix.
The vaccine is injected into the muscle at the top of the arm.
Il- vaċċin huwa injettat ġo muskolu fil- parti ta 'fuq tad- driegħ.
A booster dose of Fendrix may be given, according to official recommendations.
Skond rakkomandazzjonijiet uffiċjali, tista 'tingħata doża booster ta' Fendrix.
How does Fendrix work?
Kif jaħdem Fendrix?
Fendrix is a vaccine.
Fendrix 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- difiżi naturali tal - ġisem) kif tiddefendi lilha nnifisha kontra marda.
Fendrix contains small amounts of the ‘ surface antigen ’ (proteins from the surface) of the hepatitis B virus.
Fendrix fih ammonti żgħar ta '' antiġene tas - superfiċje '(proteini tas- superfiċje) tal- vajrus ta' l- epatite B.
When a patient is given the vaccine, the immune system recognises the surface antigens as ‘ foreign’ and makes antibodies against them.
Meta pazjent jingħata l- vaċċin, is- sistema immunitarja tagħraf l- antiġeni tas- superfiċje bħala 'barranin' u tipproduċi antikorpi kontrihom.
In the future, the immune system will be able to make antibodies more quickly when it is exposed to the hepatitis B virus.
Fil - futur, is- sistema immunitarja tkun tista 'tipproduċi antikorpi aktar malajr meta tkun esposta għall - vajrus ta' l- epatite B.
The antibodies will help to protect against the disease caused by the virus.
L- antikorpi jgħinu biex jipproteġu kontra l- marda kkaġunata mill- vajrus.
The surface antigens 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 the proteins.
L- antiġeni tas- superfiċje jsiru permezz ta 'metodu magħruf bħala' teknoloġija rekombinanti tad- DNA ': huma jsiru minn ħmira li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini.
The active substance in Fendrix has been available in other vaccines authorised in the European Union (EU) for a number of years, including Engerix-B, Ambirix, Twinrix, Tritanrix-HepB and Infanrix- HepB.
Is- sustanza attiva f' Fendrix tinsab f' vaċċini oħra awtorizzati fl- Unjoni Ewropea (UE) għal bosta snin, inklużi Engerix- B, Ambirix, Twinrix, Tritanrix- HepB u Infanrix- HepB.
In Fendrix, it is used with an ‘ adjuvant system ’ which contains ‘ MPL’, a purified fat from bacteria, and an aluminium compound.
F' Fendrix, tintuża ma '' sistema miżjuda (adjuvant) li fiha 'MPL', xaħam ippurifikat mill- batterji, u taħlita ta 'aluminju.
This system enhances the response of the immune system, which can help when vaccines are used in patients who may have a lower response, such as those with kidney problems.
Din is- sistema tkabbar u ttejjeb ir- reazzjoni tas- sistema immunitarja, li tista 'tgħin meta vaċċini jintużaw f' pazjenti li jista' jkollhom reazzjoni aktar baxxa, bħal dawk bi problemi tal- kliewi.
How has Fendrix been studied?
Kif ġie studjat Fendrix?
Because the active substance in Fendrix has been available in the EU in other vaccines, some of the data used to support the use of the other vaccines were used to support the use of Fendrix.
Minħabba li s- sustanza attiva f' Fendrix ilha disponibbli fl- UE f' vaċċini oħrajn, xi dejta li ntużat biex tappoġġa l- użu tal- vaċċini l- oħrajn intużat biex tappoġġa l- użu ta 'Fendrix.
Fendrix has been studied in one main study involving 165 patients aged 15 years and above who had kidney disease and needed haemodialysis.
Fendrix ġie studjat fi studju ewlieni wieħed li involva 165 pazjent ta 'etajiet minn 15- il sena' l fuq li kellhom mard tal- kliewi u li ħtieġu emodijaliżi.
Fendrix was compared with Engerix-B (another hepatitis B vaccine) used as a double dose.
Fendrix tqabbel ma 'Engerix- B (vaċċin ieħor kontra l - epatite B) użat bħala doża doppja.
The main measure of effectiveness was the proportion of patients who developed protective levels of antibodies to the hepatitis B virus.
Il- kejl ewlieni ta 'l- effikaċja kien il- proporzjon ta' pazjenti li żviluppaw livelli ta 'protezzjoni ta' antikorpi għall- vajrus ta 'l- epatite B.
The company also presented data on the use of Fendrix in liver transplant patients, but it withdrew the application for the use of Fendrix in these patients during the assessment.
Il- kumpanija ppreżentat ukoll dejta fuq l- użu ta 'Fendrix f' pazjenti bi trapjant tal- fwied, iżda rtirat l - applikazzjoni għal użu ta' Fendrix f' dawn il- pazjenti waqt il- valutazzjoni.
What benefit has Fendrix shown during the studies?
X' benefiċċju wera Fendrix waqt l- istudji?
Fendrix was as effective as a double dose of the comparator vaccine.
Fendrix kien effikaċi daqs doża doppja tal- vaċċin ta 'tqabbil.
One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against hepatitis B, compared with 84% of those receiving the comparator.
Xahar wara l- aħħar doża, 91% tal - pazjenti li kienu qegħdin jirċievu Fendrix kellhom livelli ta 'protezzjoni ta' antikorpi kontra epatite B, meta mqabbla ma '84% ta' dawk li kienu qegħdin jirċievu l- vaċċin ta 'tqabbil.
The effect of Fendrix lasted longer than that of the comparator vaccine:
L- effett ta 'Fendrix dam aktar minn dak ta' vaċċin ta 'tqabbil:
80% of the patients receiving Fendrix maintained protective levels of antibody for up to three years, compared with 51% of those receiving the comparator.
80% tal- pazjenti li kienu qegħdin jirċievu Fendrix żammew livelli ta 'protezzjoni ta' antikorpi sa tliet snin, meta mqabbla ma '51% ta' dawk li kienu qegħdin jirċievu l- vaċċin ta 'tqabbil.
What is the risk associated with Fendrix?
X' inhu r- riskju assoċjat ma 'Fendrix?
The most common side effects with Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling at the injection site and fatigue (tiredness).
L- aktar effetti sekondarji komuni b' Fendrix (dehru f' aktar minn pazjent 1 f' 10) huma uġigħ ta 'ras, uġigħ, ħmura, nefħa fil- punt fejn saret l- injezzjoni u għeja kbira.
For the full list of side effects reported with Fendrix, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrapportati b' Fendrix, ara l- Fuljett ta' Tagħrif.
Fendrix should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Fendrix ma għandux jintuża f' nies li jistgħu jkunu ipersensittivi (allerġiċi) għas- sustanza attiva jew għal kwalunkwe sustanza oħra tiegħu.
It should also not be used in people who have had an allergic reaction after being given a hepatitis B vaccine.
Ma għandux jintuża ukoll f' nies li kellhom reazzjoni allerġika wara li ngħataw il- vaċċin ta 'l- epatite B.
Fendrix should not be given to patients with a severe sudden fever.
Fendrix ma għandux jingħata lil pazjenti b' deni qawwi li jitla 'f' daqqa waħda.
Why has Fendrix been approved?
Għalfejn ġie approvat Fendrix?
The Committee for Medicinal Products for Human Use (CHMP) decided that Fendrix’ s benefits are greater than its risks for active immunisation against hepatitis B virus infection caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients), from the age of 15 years onwards.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Fendrix huma akbar mir- riskji tiegħu għal tilqim attiv kontra infezzjoni bil- vajrus ta' l- epatite B ikkaġunat mis- sottotipi magħrufa kollha f' pazjenti b' insuffċjenza renali (inklużi pazjenti ta 'qabel l - emodijalizi u ta' l- emodijaliżi), minn 15- il sena 'l fuq.
The Committee recommended that Fendrix be given marketing authorisation.
Il- Kumitat irrakkomanda li Fendrix jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Fendrix:
Tagħrif ieħor dwar Fendrix:
The European Commission granted a marketing authorisation valid throughout the EU for Fendrix to GlaxoSmithKline Biologicals s. a. on 2 February 2005.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Fendrix valida fl- Unjoni Ewropea kollha lil GlaxoSmithKline Biologicals s. a. fit- 2 ta 'Frar 2005.
The full EPAR for Fendrix can be found here.
L- EPAR sħiħ għal Fendrix huwa disponibbli minn hawn.
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Fendrix suspensjoni għall- injezzjoni Epatite B (rDNA) vaċċin (supplimentat, adsorbit)
1 dose (0.5 ml) of Fendrix contains:
Doża waħda (0. 5millilitru) ta ’ Fendrix fih:
Hepatitis B surface antigen 1, 2, 3 1 adjuvanted by AS04C containing:
L- antiġenu ta ’ barra ta ’ l- epatite 1, 2, 3 1 supplimentat minn AS04C li fih:
20 micrograms
20 mikrogramma
- 3-O-desacyl-4’ - monophosphoryl lipid A (MPL) 2 2 adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3
- 3- O- desacyl- 4 ’ - monophosphoryl lipid A (MPL) 2 2 adsorbit fuq aluminium phosphate (total ta ’ 0. 5 milligramma Al3+) 3
50 micrograms
50 mikrogramma
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
manifatturat f’ ċelloli tal- ħmira (Saccharomyces cerevisiae) permezz tat- teknoloġija rikombinanti tad - DNA.
For a full list of excipients, see section 6.1
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1
Turbid white suspension.
Suspensjoni bajda mhux ċara.
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Meta jkun maħżun, depożitu fin abjad b’ saff likwidu ċar u bla kulur fil - wiċċ jista ’ jiġi nnutat.
Fendrix is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients), from the age of 15 years onwards.
Fendrix huwa indikat għat- tilqim attiv kontra l- infezzjoni ikkawżata mis- sub- tipi kollha magħrufa tal - virus ta ’ l- epatite B (HBV) għall- pazjenti b’ insuffiċjenza tal- kliewi (inkluż il- pazjenti qabel jagħmlu d- dialisi tad- demm u l- pazjenti waqt li jagħmlu d- dialisi tad- demm) mill- età ta ’ 15- il sena ‘ l fuq.
Primary Immunisation schedule:
Skeda ta ’ tilqim primarju:
A four dose schedule, with immunisations at the elected date, 1 month, 2 months and 6 months from the date of the first dose is recommended.
Skeda ta ’ erba’ dożi, b’ tilqim fid- data mixtieqa, xahar, xahrejn u 6 xhur wara l- ewwel doża huwa rrakkomandat.
Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine.
Ladarba jinbeda, l- kors primarju tat- tilqim li jingħata l- ewwel darba, u wara xahar, xahrejn u sitt xhur għandu jitkompla b’ Fendrix u m’ hux b’ vaċċin ieħor HBV li jinsab fis- suq.
Booster dose:
Doża ta ’ rinforz:
As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i. e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines.
2 kroniku, għanda tiġi kkunsidrata attitudni ta ’ prekawzjoni jiġifieri li tingħata doża ta ’ rinforz biex tiżgura livell ta ’ antikorp protettiv kif mfisser fir- rakkomandazzjonijiet u l- gwidi nazzjonali.
2 Fendrix can be used as a booster dose after a primary vaccination course with either Fendrix or any other commercial recombinant hepatitis B vaccine.
Fendrix tista ’ tintuża bħala doża ta ’ rinforz wara kors ta ’ tilqim primarju b’ Fendrix jew bi kwalunkwe vaċċin rikombinanti ieħor kontra l- epatite B li hawn fis- suq.
Special dosage recommendation for known or presumed exposure to HBV:
Rakkomandazzjonijiet speċjali dwar dożi f’ każ ta ’ esponiment magħruf jew maħsub għall- HBV:
Data on concomitant administration of Fendrix with specific hepatitis B immunoglobulin (HBIg) have not been generated.
Għad ma hemmx tagħrif dwar l- amministrazzjoni ta ’ Fendrix ma ’ l- immunoglobulina speċifika ta ’ l - epatite B (HBIg).
However, in circumstances where exposure to HBV has recently occurred (e. g. stick with contaminated needle) and where simultaneous administration of Fendrix and a standard dose of HBIg is necessary, these should be given at separate injection sites.
Madanakollu f’ ċirkustanzi meta kien hemm esponiment riċenti għall- HBV (e. ż. tingiża b’ labra ikkontaminata) u fejn hemm bżonn ta ’ amministrazzjoni ta ’ Fendrix flimkien ma doża standard ta ’ HBIg, dawn għandhom jinghataw f’ siti ta ’ injezzjoni differenti.
Method of administration
Metodu ta ’ kif għandu jingħata
Fendrix should be injected intramuscularly in the deltoid region.
Fendrix għandu jingħata b’ injezzjoni fil- muskolu, fil- parti deltoid.
Hypersensitivity after previous administration of other hepatitis B vaccines.
Sensittività eċċessiva wara tilqima preċedenti b’ vaċċini oħra ta ’ l- epatite B.
Subjects suffering from acute severe febrile illness.
Suġġetti li qed isofru minn mard li jagħti deni akut u serju.
The presence of a minor infection such as a cold, is not a contraindication for immunisation.
Il- preżenza ta ’ infezzjonijiet żgħar bħal- riħ m’ humiex kontra- indikazzjonijiet għat- tilqim.
4.4 Special warnings and precautions for use
Twissijiet speċjali u prekawzjonijiet għall- użu 4. 4
Because of the long incubation period of hepatitis B, it is possible that patients could have been infected before the time of immunisation.
Minħabba l- perjodu twil ta ’ inkubazzjoni ta ’ l- epatite B, huwa possibbli li l- pazjenti jistgħu jkunu diġa ’ ġew infettati qabel il- ħin tat- tilqima.
The vaccine may not prevent hepatitis B infection in such cases.
Il- vaċċin jista ’ ma jipproteġix kontra l- infezzjoni bl- epatite B f’ każi bħal dawn.
The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or other pathogens known to infect the liver.
Il- vaċċin ma jipproteġix kontra infezzjonijiet kkawżati minn agenti oħra bħall- epatite A, l- epatite C u l- epatite E jew patoġeni oħra magħrufa li jinfettaw il- fwied.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Bħal f’ kull vaċċin ieħor, mhux kull min jitlaqqam se jieħu rispons protettiv ta ’ l- immunità.
A number of factors have been observed to reduce the immune response to hepatitis B vaccines.
Ġew nnutati li ċerti fatturi jnaqqsu r- rispons ta ’ immunità għall- vaċċin ta ’ l- epatite B.
These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases.
Dawn il- fatturi jinkludu l- età avvanzata, is- sess maskili, il- ħxuna, it- tipjip, ir- rotta kif jingħata u xi mard kroniku.
Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Fendrix.
Għandu jiġi kkunsidrat eżami seroloġiku għall- dawk is- suġġetti li jista ’ jkollhom ir- riskju li ma jilħqux seroprotezzjoni wara kors sħiħ ta Fendrix.
Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.
Dożi żejda għandhom ikunu kkunsidrati għall - persuni li ma jirrispondux jew ma jkollhomx l- aħjar rispons għal xi kors ta ’ tilqim.
Since intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, this route should be avoided.
Minħabba li l- amministrazzjoni għal ġol- muskolu gluteali tista ’ ma twassalx għall- aħjar rispons, din ir- rotta għandha tiġi evitata.
Fendrix should under no circumstances be administered intradermally or intravenously.
Fendrix m’ għandha qatt tingħata minn ġol- ġilda jew fil- vina.
Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be precluded from vaccination against hepatitis B.
Pazjenti b’ mard tal- fwied kroniku jew li għandhom l- infezzjoni ta ’ l- HIV jew li qed iġorru l- virus ta ’ l- epatite C ma jistgħux jinżammu milli jitlaqqmu kontra l- epatite B.
The vaccine could be advised since HBV infection can be severe in these patients: the Hepatitis B vaccination should thus be considered on a casebycase basis by the physician.
Għalhekk tilqim kontra l- epatite B għandu jiġi kkunsidrat mit- tabib skond il- każ xi jkun.
Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Trattament mediku addattat għandu dejjem ikun għall- lest f’ każi rari ta ’ reazzjonijiet anafilattiċi wara l- amministrazzjoni tal- vaċċin.
3 4.5 Interaction with other medicinal products and other forms of interaction
3 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
No data on the concomitant administration of Fendrix and other vaccines or with specific hepatitis B immunoglobulin have been generated.
Għad ma hemmx tagħrif dwar l- amministrazzjoni ta ’ Fendrix flimkien ma ’ vaċċini oħra jew ma ’ l - immunoglobulina speċifika tal- epatite B.
If concomitant administration of specific hepatitis B immunoglobulin and Fendrix is required, these should be given at different injection sites.
Jekk kemm– il darba jkun hemm il- bżonn li l - immunoglobulina speċifika ta ’ l- epatite B tingħata flimkien ma ’ Fendrix, dawn għandhom jingħataw f’ siti ta ’ injezzjoni differenti.
As no data are available for the concomitant administration of this particular vaccine with other vaccines, an interval of 2 to 3 weeks should be respected.
Minħabba li għad m’ hemmx tagħrif dwar l- amministrazzjoni ta ’ dan il - vaċċin partikolari flimkien ma ’ vaċċini oħra, bejniethom għandu jinżamm intervall ta ’ bejn ġimgħatejn u tlett ġimgħat.
No clinical data on use during pregnancies are available with Fendrix.
M’ hemmx tagħrif biżżejjed dwar l- użu ta’ Fendrix waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta 'l - embriju/ fetu, ħlas jew żvilupp wara t- twelid.
Vaccination during pregnancy should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the foetus.
Tilqim waqt it- tqala għandu jsir biss jekk il- proporzjon ta ’ risku għal benefiċċju fil- livell individwali jegħleb ir- riskju li jista ’ jkun hemm għall- fetu.
Adequate human data on use during lactation are not available.
M’ hemmx tagħrif biżżejjed dwar l- użu waqt it- treddiegħ.
In a reproductive toxicity study in animals which included post-natal follow-up until weaning (see section 5.3), no effect on the development of the pups was observed.
Fi studju dwar ħsara fis- sistema riproduttiva fil- bhejjem li tkompla fl- iżvilupp wara t- twelid sal- ftim (ara sezzjoni 5. 3) ma ġie osservat l- ebda effett fuq l- iżvilupp tal- frieħ.
Vaccination should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the infant.
Tilqim għandu jsir biss jekk il- proporzjon ta ’ risku għal benefiċċju fil- livell individwali jegħleb ir- riskju li jista ’ jkun hemm għat- tarbija.
Fendrix has a minor or moderate influence on the ability to drive and use machine.
Fendrix għandu effett żgħir jew moderat fuq il- ħila ta ’ sewqan u l- użu tal- magni.
Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate machinery.
Xi wħud mill- effetti mhux mixtieqa f’ sezzjoni 4. 8 jista ’ jkollhom effett fuq il- ħila ta ’ sewqan u l- użu tal- magni.
• Clinical trials involving the administration of 2476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects ≥ 15 years of age allowed to document the reactogenicity of the vaccine.
• Provi kliniċi fejn ingħataw 2476 doża ta ’ Fendrix lil 82 pazjent xi wħud qabel għamlu d- dialisi tad- demm u xi wħud waqt li kienu qed jagħmlu d- dialisi tad- demm u lill- 713 suġġetti f’ saħħithom ≥ 15- il sena wasslu għad- dokumentazzjoni tal- kapaċità tal- vaċċin li jipproduċi effetti mhux mixtieqa.
Pre-haemodialysis and haemodialysis patients
Pazjenti qabel jagħmlu d- dialisi tad- demm u pazjenti li jkunu qed jagħmlu d- dialisi tad- demm
The reactogenicity profile of Fendrix in a total of 82 pre-haemodialysis and haemodialysis patients was generally comparable to that seen in healthy subjects.
Il- profil tal- kapaċità ta ’ Fendrix li jipproduċi effetti mhux mixtieqa fit- 82 pazjent qabel għamlu d - dialisi tad- demm u l- pazjenti waqt id- dialisi tad- demm kien ġeneralment kumparabbli ma ’ dak li ġie osservat f’ ssuġġetti f’ saħħithom.
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being related or possibly related to vaccination have been categorised by frequency.
Effetti mhux mixtieqa li ġew irrappuratati fi prova klinika wara tilqim primarju b’ Fendrix u li kienu ikkunsidrat li għandhom x’ jaqsamu jew possibilment għandhom x’ jaqsmu mat- tilqim ġew ikkategorizzati skond il- frekwenza.
Frequencies are reported as:
Il- frekwenzi ġew rrappurtati hekk:
(≥ 1/ 10) Common:
Komuni:
(≥ 1/ 100 to < 1/ 10) (≥ 1/ 1,000 to < 1/ 100) (≥ 1/ 10,000 to < 1/ 1,000) (< 1/ 10,000)
(≥1/ 10) (≥1/ 100 to < 1/ 10) (≥1/ 1, 000 to < 1/ 100) (≥1/ 10, 000 to < 1/ 1, 000) (< 1/ 10, 000)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma ppreżentati f’ ordni ta ’ serjetà dejjem tonqos.
4 Gastrointestinal disorders:
4 Komuni ħafna: uġigħ ta ’ ras
Common: gastrointestinal disorder
Komuni:
General disorders and administration site conditions Very common: fatigue, pain Common: fever, injection site swelling, redness
Komuni ħafna: għeja, uġigħ Komuni: deni, nefħa fis- sit ta ’ l- injezzjoni, ħmura
Unsolicited symptoms considered to be at least possibly related to vaccination were uncommonly reported and consisted of rigors, other injection site reaction and maculo-papular rash.
Effetti mhux mixtieqa meqjusa li jista ’ jkun kellhom x’ jaqsmu mat- tilqima ma kienux irrapurtati b’ mod komuni u kienu jikkonsistu f’ tertir, reazzjonijiet oħra fis- sit ta ’ l- injezzjoni u raxx makulari bl - infafet.
Healthy subjects
Suġġetti f’ saħħithom
The reactogenicity profile of Fendrix in healthy subjects was generally comparable to that seen in pre- haemodialysis and haemodialysis patients.
Il- profil ta ’ kif suġġetti f’ saħħithom irreaġixxew għal Fendrix kien ġeneralment jixbaħ dak li ġie nnutat fil- pazjenti qabel għamlu d- dialisi tad- demm u l- pazjenti waqt li qed jagħmlu d- dialisi tad - demm.
In a large double-blind randomised comparative study, healthy subjects were enrolled to receive a three dose primary course of Fendrix (N= 713) or a commercially available hepatitis B vaccine (N= 238) at 0, 1, 2 months.
Fi studju kbir kumparattiv li kien b’ ordni addoċċ u double- blind, suġġetti f’ saħħithom ġew irreġistrati biex jingħataw kors primarju ta ’ tlett dożi ta ’ Fendrix (N=713) jew inkella vaċċin ta ’ l- epetite B li jinsab fis- suq (N=238) fid- data magħżula, xahar u xahrejn wara.
Fendrix was generally well tolerated.
Ġeneralment Fedrix kien ittolerat tajjeb.
The most common adverse events reported were local reactions at the injection site.
L- aktar effetti komuni mhux mixtieqa li ġew irrappurtati kienu reazzjonijiet lokali fis- sit ta ’ l - injezzjoni.
Vaccination with Fendrix induced more transient local symptoms as compared to the comparator vaccine, with pain at the injection site being the most frequently reported solicited local symptom.
Tilqim b’ Fendrix ikkaġuna aktar sintomi għal- żmien qasir meta mqabbel mal- vaċċin użat bħala strument biex tqabbel, b’ uġigħ fis- sit ta ’ l- injezzjoni bħala l- aktar sintomu lokali irrapurtat.
However, solicited general symptoms were observed with similar frequencies in both groups.
Madana kollu, sintomi ġenerali ġew nnutati bl- istess frekwenza fiż- żewġ gruppi.
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being at least possibly related to vaccination have been categorised by frequency.
Reazzjonijiet mhux mixtieqa rrappurtati fi prova klinika wara tilqim primarju b ’ Fendrix u meqjusa li possibilment għandhom xi ftit x’ jaqsmu mat- tilqim ġew ikkategorizzati skond il- frekwenza.
Ear and labyrinth disorders:
Disturbi fil- widnejn u fis- sistema labirintika:
Rare: vertigo
Rari: sturdament
Common: gastrointestinal disorder
Komuni: disturb gastro- intestinali
Muskuloskeletal and connective tissue disorders:
Disturbi muskolu- skeltrali u tal- connective tissue:
Rare: tendinitis, back pain
Rari: infjammazzjoni ta ’ l- għerq, uġigħ fid- dahar
Rare: viral infection
Rari: infezzjoni virali
General disorders and administration site conditions Very common: injection site swelling, fatigue, pain, redness Common: fever Uncommon: other injection site reaction Rare: rigors, hot flushes, thirst, asthenia
Komuni ħafna: nefħa fis- sit ta ’ l- injezzjoni, għeja, uġigħ, ħmura, Komuni: deni Mhux komuni: reazzjoni oħra fis- sit ta ’ l- injezzjoni Rari: tertir, fwawar, għatx, astenja
Rare: allergy
Rari: allerġija
Rare: nervousness
Mard psikjatriku:
5 No increase in the reactogenicity was observed after the booster vaccination with respect to the primary vaccination.
Nervożiżmu
Allergic reactions, including anaphylactoid reactions, may occur very rarely.
Ma ġiet innutata l- ebda żieda fl- inċidenza jew qawwa ta ’ dawn l- effetti mhux mixtieqa meta ngħataw id- dożi li kien jonqos fl- iskeda tat- tilqim primarju.
• Experience with hepatitis B vaccine:
• Esperjenza bil- vaċċin ta ’ l- epatite B:
Following widespread use of hepatitis B vaccines, in very rare cases, syncope, paralysis, neuropathy, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis and convulsions have been reported.
Wara użu estensiv tal- vaċċin ta ’ l- epatite B, f’ każi rari ħafna, ġew irrapurtati, reqqet ir- ruħ, paraliżi, newropatija, newrite (inkluż il- marda ta ’ Guillain- Barré, newrite ottika u sklerożi multipla), enkefalite, enkefalopatija, meninġite u konvulżjonijiet.
The causal relationship to the vaccine has not been established.
Jekk huwiex il- vaċċin li jikkawża dawn għadu ma ġiex stabbilit.
PHARMACOLOGICAL PROPERTIES
TAGĦRIF FARMAKOLOĠIKU 5.
Hepatitis vaccines, ATC code J07BC01.
Kategorija farmakoterapewtika: vaċċini tal- epatite, ATC Kodiċi JO7BC01
Fendrix induces specific humoral antibodies against HBsAg (anti-HBs antibodies).
Fendrix tinduċi antikorpi speċifiċi ta ’ l- umuri kontra l- HbsAg (antikorpi kontra l- HBs).
An anti-HBs antibody titre ≥ 10 mIU/ ml correlates with protection to HBV infection.
Titre ta ’ antikorpi ≥ 10mIU/ ml jikkorelata ma ’ protezzjoni mill- infezzjoni bil- HBV.
It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Huwa mistenni li tilqim b ’ Fendrix jista ’ jilqgħa wkoll kontra l- epatite D minħabba li l- epatite D (ikkawżata mill- aġent delta) ma tiġrix fin- nuqqas ta ’ infezzjoni bl- epatite B.
Immunological data
Tagħrif dwar l- immunità
In pre-haemodialysis and haemodialysis patients:
Fil- pazjenti ta’ qabel id- dialisi tad- demm u ta’ waqt id- dialisi tad- demm:
In a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and above), protective levels of specific humoral antibodies (anti-HBs titres ≥ 10 mIU/ ml) were observed in 74.4% of Fendrix recipients (N = 82) one month after the third dose (i. e at month 3), as compared to 52.4% of patients in the control group who received a double dose of a commercially available hepatitis B vaccine (N = 83) for this population.
Fi studju kliniku kumparattiv f’ 165 pazjent ta ’ qabel id- dialisi tad- demm u ta ’ waqt id- dialisi tad - demm (minn 15- il sena ‘ l fuq), xahar wara t- tielet doża (jiġifieri fit- tielet xahar), kienu osservati livelli protettivi ta ’ antikorpi speċifiċi ta ’ l- umuri (titres ta ’ kontra l- HBs ≥ 10mIU/ ml) f’ 74. 4% ta’ dawk li ħadu Fendrix (N=82) meta mqabbla ma ’ 52. 4% tal- pazjenti tal- grupp ta ’ kontroll li rċievew doża doppja ta ’ vaċċin ta ’ l- epatite B li hawn fis- suq (N=83).
At month 3, Geometric Mean Titres (GMT) were 223.0 mIU/ ml and 50.1 mIU/ ml in the Fendrix and control groups respectively, with 41.0% and 15.9% of subjects with anti-HBs antibody titres ≥ 100 mIU/ ml respectively.
Fit- 3 xahar Titres Ġometriċi Medji (TGM) kienu ta ’ 223. 0 mIU/ ml u 50. 1mIU/ ml fil- grupp ta ’ Fendrix u ta ’ kontroll rispettivament, b’ 41% u 15. 9% rispettivament tas- suġġetti b’ titres ta ’ antikorpi ta ’ kontra l- HBs ≥ 100mIU/ ml.
After completion of a four dose primary course (i. e at month 7), 90.9% of Fendrix recipients were seroprotected (≥ 10 mIU/ ml) against hepatitis B, in comparison with 84.4% in a control group who received the commercially available hepatitis B vaccine.
Wara li tlesta l- kors primarju ta ’ l- ewwel erba ’ dożi (jiġifieri fis- 7 xahar), 90. 9% ta ’ dawk li ħadu Fendrix kellhom seroprotezzjoni (≥ 10mIU/ ml) kontra l- epatite B meta mqabbla ma 84. 4% tal- grupp ta’ kontroll li ħadu l- vaċċin ta ’ l- epatite B li hawn fis- suq.
At month 7, GMTs were 3559.2 mIU/ ml and 933.0 mIU/ ml in the Fendrix and control groups who received the commercially available hepatitis B vaccine respectively, with 83.1% and 67.5% of subjects with anti-HBs antibody titres ≥ 100 mIU/ ml respectively.
Fis- 7 xahar, it- TGM kienu ta ’ 3559. 2mIU/ ml u 933. 0mIU/ ml rispettivament fil- grupp ta ’ Fendrix u l - grupp ta ’ kontroll li ħadu l- vaċċin ta ’ l- epatite B li hawn fis- suq, b’ 83. 1% u 67. 5% rispettivament tas - suġġetti b’ titres ta ’ antikorpi kontra l- HBs ≥100mIU/ ml.
Antibody persistence
Persistenza ta ’ l- antikorp
In pre-haemodialysis and haemodialysis patients:
6 Fil- pażjenti ta’ qabel id- dialisi tad- demm u ta’ waqt id- dialisi tad- demm:
Anti-HBs antibodies have been shown to persist for at least 36 months following a 0, 1, 2, 6 month primary course of Fendrix in pre-haemodialysis and haemodialysis patients.
Antikorpi kontra l- HBs intwerew li jippersistu għal ta ’ l- anqas 36 xhahar wara kors b ’ Fendrix f ’ 0, 1, 2, 6 xahar fil- pazjenti ta ’ qabel id- dialisi tad- demm u ta ’ waqt id- dialisi tad- demm.
At month 36, 80.4% of these patients retained protective antibody levels (anti-HBs titres ≥ 10mIU/ ml), as compared to 51.3% of patients who received a commercially available hepatitis B vaccine.
Fis- 36 xahar, 80. 4% ta ’ dawn il- pazjenti żammew il- livelli protettivi ta ’ antikorpi (titres ta ’ kontra l- HBs ≥ 10mIU/ ml) meta mqabbla ma 51. 3% tal- pazjenti li rċievew il- vaċċin ta ’ l- epatite B li hawn fis- suq.
6 At month 36, GMTs were 154.1 mIU/ ml and 111.9 mIU/ ml in the Fendrix and control groups respectively, with 58.7% and 38.5% of subjects with anti-HBs antibody titres ≥ 100 mIU/ ml respectively.
Fis- 36 xahar, il- GMTs kienu 154. 1mIU/ ml u 111. 9mIU/ ml rispettivament fil- grupp ta ’ Fendrix u l - grupp ta ’ kontroll, b’ 83. 1% u 67. 5% rispettivament tas- suġġetti b’ titres ta ’ antikorpi kontra l- HBs ≥100mIU/ ml.
Pharmacokinetic properties of Fendrix or MPL alone has not been studied in humans.
Evalwazzjoni ta ’ karatteristiċi farmakokinetiċi ta ’ Fendrix jew MPL waħedhom ma kienux studjati fil - bnedmin.
Non-clinical data reveal no special hazard for humans based on conventional animal studies consisting of acute and repeated dose toxicity, cardiovascular and respiratory safety pharmacology and reproductive toxicity including pregnancy and peri and postnatal development of the pups till weaning (see section 4.6).
Tagħrif mhux kliniku magħmul fuq studji konvenzjonali fl- annimali ta ’ l- effett tossiku minn dożi ripetuti u akuti, sigurtà farmakoloġika kardiovaskulari u respiratorja u ta ’ l- effett tossiku fuq is- sitema riproduttiva inkluż fit- tqala u fl- iżvilupp ta ’ qabel u wara t- twelid tal- frieħ sal- ftim ma juru l- ebda periklu speċjali għall- bnedmin (ara sezzjoni 4. 6).
Sodium chloride Water for injections
Sodium Chloride Ilma għall- injezzjonijiet
For adjuvants, see section 2.
6. 2 Inkompatibilitajiet
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġinali, sabiex tilqa ’ mid- dawl.
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without separate needle in a pack size of 1, or without needles in a pack size of 10.
0. 5 millilitru ta ’ suspenjoni f’ siringa mimlija għall- lest (ħġieġ tat- tip 1) magħluqa bi planġer (lakstu butyl) b’ labra jew bla labra f’ pakketti ta’ 1, jew mingħajr labra f’ pakketti t’ 10.
6.6 Special precautions for disposal and other handling
7 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar iehor
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Meta jkun maħżun, jista ’ jiġi nnutat depożitu fin u abjad b’ saff likwidu ċar bla kulur fil- wiċċ.
Before administration, the vaccine should be well shaken to obtain a slightly opaque, white suspension.
Qabel ma jingħata l- vaċċin għandu jiġi mħallat sewwa biex tinkiseb suspensjoni bajdanija u xi ftit opaka.
7 The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/ or change in physical appearance.
Il- vaċċin għandu jkun mifli sew għal xi frak u / jew xi tibdil fl- aspett fiżiku kemm qabel kif ukoll wara li jitħallat.
The vaccine must not be used if any change in the appearance of the vaccine has taken place.
Il- vaċċin m’ għandux jintuża jekk tkun saret kwalunkwe bidla fid- dehra tal- vaċċin.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- vaċċin li ma jiġix użat jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Rue de l'Institut 89 B-1330 Rixensart, Belgium
GlaxoSmith Kline Biologicals s. a Rue de l’ Institut 89 B- 1330 Rixensart, Il- Belġju
02 February 2005
02 ta ’ Frar 2005
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
9 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT
89, rue de l’ Institut – 1330 Rixensart Belgium
89, Rue de l’ Institut - 1330 Rixensart Il- Belġju
GlaxoSmithKline Biologicals S. A.
GlaxoSmith Kline Biologicals S. A.
89, rue de l’ Institut – 1330 Rixensart Belgium
89, Rue de l’ Institut – 1330 Rixensart Il- Belġju
The Marketing Authorisation Holder will continue to submit 6-monthly PSUR’ s.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jkompli jissottometti l- PSUR kull sitt xhur.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta 'din l- awtorizzazzjoni għat- tqegħid fis- suq għandu jagħti tagħrif lill- Kummissjoni Ewropea dwar il- pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b' din id- deċiżjoni.
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH SEPARATE NEEDLE:
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA SIRINGA MIMLIJA GĦAL- LEST B’ LABRA SEPARATA:
PACK OF 1 PRE-FILLED SYRINGE WITHOUT NEEDLE:
PAKKETT TA ’ 1 SIRINGA MIMLIJA GĦAL- LEST MINGĦAJR LABRA:
PACK OF 1 PRE-FILLED SYRINGE WITHOUT NEEDLES:
PAKKETT TA ’ 1 SIRINGA MIMLIJA GĦAL- LEST MINGĦAJR LABAR:
PACK OF 10
PAKKETT TA ’ 10
Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Fendrix suspensjoni għall- injezzjoni Epatite B (rDNA) vaċċin (supplimentat, adsorbit)
1 dose (0.5 ml):
Doża waħda (0. 5ml):
Hepatitis B surface antigen1, 2, 3 1 adjuvanted by AS04C containing:
L- antiġenu ta ’ barra ta ’ l- epatite B1, 2, 3 1 supplimentat minn AS04C li fih:
- 3-O-desacyl-4’ - monophosphoryl lipid A (MPL) 2 2 adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3
- 3- O- desacyl- 4 ’ - monophosphoryl lipid A (MPL) 2 2 adsorbit fuq aluminium phosphate (total ta ’ 0. 5 milligrammi Al3+) 3
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
manifatturat f’ ċelloli tal- ħmira (Saccharomyces cerevisiae) permezz tat- teknoloġija rekombinanti tad - DNA.
Sodium chloride Water for injections
Sodium Chloride Ilma għall- injezzjoni
Pre-filled syringe Separate needle 1 dose (0.5 ml)
Siringa mimlija għal- lest Doża waħda (0. 5 ml)
Intramuscular use Shake before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu Użu għal ġol- muskoli Ħawwad qabel tuża
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
Aħżen fi friġġ Tagħmlux fil- friża Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl
Dispose of in accordance with local regulations
Iddisponi minnu skond ir- regoli lokali
Rue de l’ Institut 89 B-1330 Rixensart, Belgium
GlaxoSmithKline Biologicals s. a Rue de l’ Institut 89 B- 1330 Rixensart, Il- Belġju
EU/ 1/ 04/ 0299/ 001 – pack of 1 with separate needle EU/ 1/ 04/ 0299/ 002 – pack of 1 without needle EU/ 1/ 04/ 0299/ 003 – pack of 10 without needles
EU/ 1/ 04/ 0299/ 001 – pakkett ta ’ 1 b’ labra separata EU/ 1/ 04/ 0299/ 002 – pakkett ta ’ 1 mingħajr labra EU/ 1/ 04/ 0299/ 003 – pakkett ta ’ 10 mingħajr labar
Justification for not including Braille accepted
Il- Ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata.
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PACK SIZE OF 1 SYRINGE WITH A SEPARATE NEEDLE PACK SIZE OF 1 SYRINGE WITHOUT NEEDLE PACK SIZE OF 10 SYRINGES WITHOUT NEEDLES
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN PAKKETT B’ SIRINGA WAĦDA U B’ LABRA SEPARATA PAKKETT B’ SIRINGA WAĦDA MINGĦAJR LABRA PAKKETT B’ 10 SIRINGI MINGĦAJR LABAR
Fendrix suspension for injection IM
Fendrix suspensjoni għall- injezzjoni IM
Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Epatite B (rDNA) vaċċin (supplimentat, adsorbit).
Read all of this leaflet carefully before you start receiving this vaccine.
Aqra dan il- fuljett kollu qabel tibda tieħu dan il- vaċċin
- If you have any further questions, ask your doctor or your pharmacist.
- Jekk ikollok xi mistoqsijiet oħra, staqsi lit- tabib jew lill- ispiżjar tiegħek.
- This vaccine has been prescribed for you.
- Dan il- vaċċin ġie preskritt għalik.
What Fendrix is and what it is used for 2.
X’ inhu Fendrix u għalxiex jintuża 2.
Before you receive Fendrix 3.
Qabel ma tieħu Fendrix 3.
How Fendrix is given 4.
Kif għandu jingħata Fendrix 4.
How to store Fendrix 6.
Kif taħżen Fendrix 6.
WHAT FENDRIX IS AND WHAT IT IS USED FOR
X’ INHU FENDRIX U GĦALXIEX JINTUŻA
Fendrix is a vaccine which prevents hepatitis B disease in patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients) from the age of 15 years onwards.
Fendrix huwa vaċċin li jilqgħa kontra l- marda ta ’ l- epatite B f’ pazjenti li għandhom insuffiċjenza tal - kliewi (inkluż dawk il- pazjenti ta ’ qabel id- dialisi tad- demm u dawk ta ’ waqt id- dialisi tad- demm) minn 15- il sena l- fuq.