qanastek/EMEA-V3 huggingface dataset:
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, Ir- Renju Unit.
The Manufacturer is:
Il- Manifattur hu:
Gödecke GmbH (a pharma plant of Pfizer GmbH), Mooswaldallee 1, 79090 Freiburg, Germany.
Gödecke GmbH (impjant farma ta ’ Pfizer GmbH), Mooswaldallee 1, 79090 Freiburg, Il- Ġermanja.
61 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull informazzjoni dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
België/ Belgique/ Belgien Pfizer S. A. / N. V.
67 België/ Belgique/ Belgien Pfizer S. A. / N. V.
Sverige Pfizer AB Tel: +46 (0)8 550 520 00
Sverige Pfizer AB Tel: +46 (0) 8 550520 00
Latvija Pfizer Luxembourg SARL Filiā le Latvijā Tel: + 371 670 35 775
68 Latvija Pfizer Luxembourg SARL Filiāle Latvijā Tel: + 371 670 35 775 Lietuva Pfizer Luxembourg SARL, filialas Lietuvoje Tel: +3705 2514000
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’ Settembru 2007.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: 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 /.
What is Celvapan?
X’ inhu Celvapan?
Celvapan is a vaccine that is given by injection.
Celvapan huwa vaċċin li jingħata b’ injezzjoni.
It contains influenza (flu) viruses that have been inactivated (killed).
Fih partijiet ta ’ viruses tal- influwenza li ġew diżattivati (maqtula).
Celvapan contains a flu strain called A/ VietNam/ 1203/ 2004 (H5N1).
Celvapan fih razza ta ’ influwenza msejħa A/ Viet Nam/ 1203/ 2004 (H5N1).
What is Celvapan used for?
Għal xiex jintuża Celvapan?
Celvapan is a vaccine to prevent ‘ pandemic’ flu.
Celvapan huwa vaċċin li jipprevjeni l- influwenza ‘ pandemika ’.
It should only be used once a flu pandemic has been officially declared by the World Health Organization or European Union (EU).
Pandemrix hija vaċċin li tista ’ tintuża biss ladarba tkun ġiet iddikjarata uffiċjalment influwenza ‘ pandemika ’ mill- Għaqda Dinjija tas- Saħħa (WHO) jew mill- Unjoni Ewropea (EU).
A flu pandemic happens when a new type (strain) of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it.
Influwenza pandemika sseħħ meta joħroġ tip ta ’ virus ġdid (razza) tal- virus tal- influwenza li jista ’ jinfirex faċilment minn persuna għal oħra peress li n- nies ma jkollom l- ebda immunità (protezzjoni) kontra tiegħu.
A pandemic can affect most countries and regions around the world.
Pandemija tista ’ taffettwa l- parti l- kbira tal - pajjiżi u r- reġjuni madwar id- dinja.
Celvapan would be given according to official recommendations.
Celvapan jingħata skont ir- rakkomandazzjonijiet uffiċjali.
Celvapan has been studied in adults, including the elderly (above 60 years of age).
Celvapan ġie studjat fl- adulti, fosthom anki l- anzjani (li għandhom ’ il fuq minn sittin sena).
The vaccine can only be obtained with a prescription.
Il- vaċċin jista 'tinkiseb biss b' riċetta tat- tabib.
How is Celvapan used?
Kif jintuża Celvapan?
Celvapan is given by injection into the shoulder muscle in two doses, at least three weeks apart.
Celvapan jingħata b’ injezzjoni fil- muskolu tal- parti ta ’ fuq tad- driegħ f’ żewġ dożi, mill- anqas bi tliet ġimgħat bejniethom.
How does Celvapan work?
Kif jaħdem Celvapan?
Celvapan is a ‘ mock-up’ vaccine.
Celvapan huwa vaċċin tat- tip “ finta ”.
This is a special type of vaccine that is designed to help with the management of a pandemic.
Dan huwa tip speċjali ta ’ vaċċin li jista ’ jiġi żviluppat biex jgħin fil- ġestjoni ta ’ pandemija.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
Qabel tibda pandemija, ħadd ma jkun jaf liema razza ta ’ virus tal- influwenza se jkun involut, għalhekk il- kumpaniji ma jistgħux jippreparaw il- vaċċin korrett minn qabel.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Minflok, huma jistgħu jippreparaw vaċċin li fih ir- razza ta ’ virus tal- influwenza magħżul speċifikament peress li ħadd ma kien espost għalih, u għalhekk ħadd ma jkun immuni għalih.
They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
Huma jistgħu jittestjaw dan il- vaċċin biex jaraw kif se tkun ir- reazzjoni tan- nies, biex imbagħad ikollhom idea sabiex ibassru kif in- nies se jirreaġġixxu meta r- razza tal- influwenza li tikkaġuna l- pandemija tkun inkluża.
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 nfisha kontra marda.
Celvapan contains a virus called H5N1 that has been inactivated (killed) so that it does not cause any disease.
Celvapan fih virus imsejjaħ H5N1 li ġie diżattivat (maqtul) ħalli ma jikkawżax mard.
When a person is given the vaccine, the immune system recognises the inactivated virus as ‘ foreign’ and makes antibodies against it.
Jekk tibda pandemija, ir- razza ta ’ virus f’ Celvapan tinbidel bir- razza li tikkaġuna l - pandemija qabel mal- vaċċin ikun jista ’ jintuża.
The viruses used in Celvapan are grown in mammal cells (‘ vero cells’), unlike those in some other flu vaccines, which are grown in hen ’ s eggs.
Il- virusis użati f' Celvapan jitkabbru f' ċelloli tal- mammiferi (“ vero cells ”), kuntrarjament għal dawk użati f' vaċċini oħra tal- influwenza, li jitkabbru fil- bajd tat- tiġieġ.
How has Celvapan been studied?
Kif ġie studjat Celvapan?
The effects of Celvapan were first tested in experimental models before being studied in humans.
L- effetti ta 'Celvapan għall- ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fil - bniedem.
The main study of Celvapan included 561 healthy volunteers, 281 of whom were over the age of 60 years.
L- istudju ewlieni ta ’ Celvapan inkluda 561 voluntiera b’ saħħithom, 281 minnhom kellhom ’ il fuq minn 60 sena.
The study looked at the ability of two 7.5-microgram doses of Celvapan, given 21 days apart, to trigger the production of antibodies (‘ immunogenicity’). The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 21), and 21 days after the second vaccination (day 42).
Il- kejl ewlieni tal- effikaċja kienu l- livelli ta ’ antikorpi kontra l- virus fid- demm qabel ingħata l- vaċċin, dakinhar tat- tieni injezzjoni (il- 21 jum), u wieħed u għoxrin jum wara li ngħata l- vaċċin (it- 42 jum).
What benefit has Celvapan shown during the studies?
X’ benefiċċji wera Celvapan matul l- istudji mwettqa?
According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Skond il- kriterji stabbiliti mill- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP), vaċċin “ finta ” jeħtieġ li joħloq livelli ta ’ protezzjoni ta ’ antikorpi f’ mhux inqas minn 70% tal- persuni biex jitqies stabbli.
The study showed that Celvapan produced an antibody response that met these criteria.
L- istudju wera li Celvapan produċa reazzjoni ta ’ antikorpi laħqet dawn il- kriterji.
At 21 days after the second injection, 72% of the adults below 60 years of age (192 out of 265) and 74% of those above 60 years of age (200 out of 270) had levels of antibodies that would protect them against H5N1.
Wara wieħed u għoxrin jum mit- tieni injezzjoni, 72% tal- adulti ta ’ taħt is- sittin sena (192 minn 265) u 74% ta ’ dawk ’ il fuq minn 60 sena (200 minn 270) kellhom livelli ta ’ antikorpi li kienu jipprpteġuhom kontra l- H5N1.
What is the risk associated with Celvapan?
X’ inhu r- riskju assoċjat ma ’ Celvapan?
The most common side effect with Celvapan (seen in more than 1 people vaccinated in 10) is pain at the site of the injection.
L- aktar effett sekondarju komuni b' Celvapan (li deher f' iktar minn pazjent 1 minn 10 li ngħataw il - vaċċin) hu wġigħ fil- post fejn ingħatat l- injezzjoni.
For the full list of all side effects reported with Celvapan, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati ma ’ Celvapan, ara l- Fuljett ta ’ Tagħrif.
Celvapan should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
Celvapan ma għandux jingħata lil nies li fil- passat kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill- komponenti tal- vaċċin, jew għal kwalunkwe sustanza li tinsab f’ livelli ta ’ traċċi (ftit ħafna) fil- vaċċin, bħalma huma l- formaldeħajd (gass bla kulur b’ riħa qawwija użat bħala preżervattiv u diżinfettant meta jinħall fl- ilma), il- benzonase jew iz- zokkor tal- kannamieli.
If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.
Madankollu, jekk tkun bdiet pandemija, jista ’ jkun xieraq li dawn il- pazjenti jingħataw il- vaċċin, diment li jkun hemm preżenti faċilitajiet għar- rianimazzjoni.
Why has Celvapan been approved?
Għaliex ġie approvat Celvapan?
The CHMP decided that Celvapan’ s benefits are greater than its risks for the prophylaxis of influenza in an officially declared pandemic situation.
Is- CHMP iddeċieda li l- benefiċċji ta ’ Celvapan huma akbar mir- riskji tiegħu għal profilassi ta ’ influwenza f’ sitwazzjoni pandemika dikjarata uffiċjalment.
The Committee recommended that Celvapan be given marketing authorisation.
Il- Kumitat irrakkomanda li Celvapan jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Celvapan has been authorised under ‘ Exceptional Circumstances’.
Celvapan ġie awtorizzat taħt “ Ċirkostanzi Eċċezzjonali ”.
This means that because the strain of flu virus that may cause a pandemic is not known, it has not been possible to obtain full information about the future pandemic vaccine.
Dan ifisser li minħabba li r- razza tal- virus tal- influwenza li jista ’ jikkaġuna pandemija mhijiex magħrufa, ma kienx possibbli li jinkiseb tagħrif sħiħ dwar il- vaċċin ta ’ pandemija futura.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea għall- Mediċini (l- EMEA) tirrevedi kwalunkwe tagħrif ġdid li jista 'jinkiseb u dan is- sommarju se jiġi aġġornat kif meħtieġ.
What information is still awaited for Celvapan?
X’ tagħrif għadu mistenni dwar Celvapan?
If a pandemic is declared, the company that makes Celvapan will include the flu strain responsible in the vaccine.
Jekk tiġi ddikjarata pandemija, il- kumpanija li tagħmel Celvapan għandha tinkludi fil- vaċċin ir- razza tal- influwenza li tkun responsabbli.
It will then collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Imbagħad, hija tiġbor it- tagħrif dwar is- sigurtà u l- effettività tal - vaċċin pandemiku finali, u tisottomettih lis- CHMP għal evalwazzjoni.
Which measures are being taken to ensure the safe use of Celvapan?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Celvapan?
If Celvapan is used during a pandemic, the company that makes it will collect information on the safety of the vaccine while it is being used.
Jekk Celvapan jintuża waqt pandemija, il- kumpanija li tagħmlu trid tiġbor tagħrif dwar is- sigurtà tal - vaċċin waqt li jkun qed jintuża.
This will include information on its side effects and its safety in the elderly, pregnant women, patients with severe conditions, and people who have problems with their immune systems.
Dan jinkludi tagħrif fuq l- effetti sekondarji tiegħu u s- sigurtà tiegħu fit- tfal, nisa tqal, pazjenti b’ kundizzjonijiet serji, u nies li għandhom problemi bis- sistemi immunitarji tagħhom.
Other information about Celvapan:
2/ 3 Tagħrif ieħor dwar Celvapan:
The European Commission granted a marketing authorisation valid throughout the EU for Celvapan to Baxter AG on 04 March 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq valida madwar l- Unjoni Ewropea, għal Celvapan lil Baxter AG fil- 04 ta ’ Marzu 2009.
The full EPAR for Celvapan can be found here.
L- EPAR sħiħ għal Celvapan jista ’ jiġi kkonsultat hawn.
This summary was last updated in 03-2009.
Dan is- sommarju kien aġġornat l- aħħar fi:
Suspension for injection
Suspensjoni għall- injezzjoni
Intramuscular use
Jingħata ġol- muskolu
20 vials
20 kunjett
CELVAPAN suspension for injection Pandemic influenza vaccine (whole virion, Vero cell derived, inactivated)
CELVAPAN suspensjoni għall- injezzjoni Vaċċin kontra l- influwenza pandemika (virion sħiħ, derivat miċ- ċelluli Vero, inattivat)
Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*:
Vaċċin kontra l- influwenza b’ virion sħiħ, inattivat, li fih antiġen ta ’ razza pandemika *:
A/ Vietnam/ 1203/ 2004 (H5N1) per 0.5 ml dose
A/ Vjetnam/ 1203/ 2004 (H5N1) għal kull doża ta ’ 0. 5 ml
7.5 micrograms**
7. 5 mikrogrammi **
* propagated in Vero cells (continuous cell line of ** expressed in micrograms haemagglutinin.
* propagati f’ ċelluli Vero (razza ta ’ ċelluli kontinwi ** espressi f’ mikrogrammi emaglutinin
mammalian origin)
ta ’ oriġini mammaljana)
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Din it- tilqima tikkonforma mar- rakkomandazzjoni tal- WHO u mad- deċiżjoni tal- UE għall- pandemika.
This is a multidose container.
Dan huwa reċipjent ta ’ aktar minn doża waħda.
See section 6.5 for the number of doses per vial.
Ara sezzjoni 6. 5 għan- numru ta ’ dożi f’ kull kunjett.
Suspension for injection.
Suspensjoni għall- injezzjoni.
The vaccine is an off-white, opalescent, translucent suspension.
Il- vaċċin huwa suspensjoni ta ’ lewn ofwajt, opalexxenti u transluċidu.
Prophylaxis of influenza in an officially declared pandemic situation.
Profilassi tal- influwenza f’ sitwazzjoni pandemika ddikjarata b’ mod uffiċjali.
Pandemic influenza vaccine should be used in accordance with official guidance.
Il- vaċċin kontra l- influwenza pandemika għandu jintuża skont il- gwida uffiċjali.
CELVAPAN has been evaluated in adults 18-59 years of age and in elderly 60 years of age and above.
CELVAPAN ġie evalwat f’ persuni adulti ta ’ bejn 18- 59 sena u anzjani ta ’ 60 sena u aktar.
Adults: first dose of 0.5 ml at an elected date.
Adulti: l- ewwel doża ta ’ 0. 5 ml f’ data magħżula.
A second dose of vaccine should be given after an interval of at least 3 weeks.
Għandha tingħata doża oħra tal- vaċċin wara intervall ta ’ mill- anqas 3 ġimgħat.
There is no data on CELVAPAN vaccination dose and schedule for subjects under 18 years old and for subjects with co-morbidities (e. g. immunosuppressed subjects).
M’ hemmx informazzjoni dwar id- doża u l- iskeda tat- tilqima CELVAPAN għal individwi ta ’ taħt it - 18- il sena u għal individwi b’ ko- morbożitajiet (eż. individwi immunosoppressi).
In a pandemic situation administration of the vaccine in those populations shall follow national recommendations.
F’ sitwazzjoni pandemika, l- għoti tal- vaċċin f’ dawn il- popolazzjonijiet għandu jsegwi r- rakkomandazzjonijiet nazzjonali.
For further information, see section 5.1.
Għal aktar informazzjoni, ara sezzjoni 5. 1.
Immunization should be carried out by intramuscular injection into the deltoid muscle.
L- immunizzazzjoni għandha ssir permezz ta ’ injezzjoni ġol- muskoli fil- muskolu deltojde.
2 4.3 Contraindications
2 4. 3 Kontra- indikazzjonijiet
History of an anaphylactic (i. e. life-threatening) reaction to any of the constituents or trace residues (e. g. formaldehyde, benzonase, sucrose) of this vaccine.
Storja ta ’ reazzjoni anafilattika (jiġifieri ta ’ theddida għall- ħajja) għal xi komponenti jew residwi fi traċċa (eż. formaldehyde, benzonase, sucrose) ta ’ dan il- vaċċin.
However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Madankollu, f’ sitwazzjoni pandemika, jista ’ jkun xieraq li jingħata l- vaċċin, bil- kundizzjoni li l- faċilitajiet għar- risuxxitazzjoni jkunu disponibbli dak il- ħin fil- każ li jkunu meħtieġa.
See section 4.4.
Ara sezzjoni 4. 4.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance(s), to any of the excipients and to trace residues e. g. formaldehyde, benzonase, or sucrose.
Hija meħtieġa l- kawtela meta dan il- vaċċin jingħata lil persuni b’ sensittività eċċessiva magħrufa (għajr reazzjoni anafilattika) għas- sustanza( i) attiva( i), għal kwalunkwe sustanza mhux attiva u għal residwi ta ’ traċċa eż. formaldehyde, benzonase, jew sucrose.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal b’ kull tilqima li tiġi injettata, trattament mediku xieraq kif ukoll sorveljanza xierqa għandhom ikunu dejjem disponibbli dak il- ħin fil- każ ta ’ avveniment anafilattiku rari wara l- amministrazzjoni tat- tilqima.
If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Jekk is- sitwazzjoni pandemika tippermetti, l- immunizzazzjoni għandha tiġi posposta f’ pazjenti b’ mard febrili sever jew b’ infezzjoni akuta.
CELVAPAN should under no circumstances be administered intravascularly.
CELVAPAN ma għandu qatt u taħt l- ebda ċirkostanza jingħata ġol- vini.
There are no data with CELVAPAN using the subcutaneous route.
M’ hemm l- ebda dejta dwar CELVAPAN meta jingħata taħt il- ġilda.
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Għalhekk, dawk li jipprovdu l- kura tas- saħħa jeħtieġ li jevalwaw il- benefiċċji u r- riskji potenzjali li tingħata tilqima lil persuni li jkollhom tromboċitopenja jew kwalunkwe disturb ta ’ emottaġija li hija kontra- indikata għall- injezzjoni ġol- muskoli, ħlief jekk il- benefiċċju potenzjali jiżboq ir- riskju ta ’ ħruġ ta ’ demm.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Ir- rispons tal- antikorpi f’ pazjenti b’ immunosuppressjoni endoġena jew ijatroġenika jista ’ ma jkunx biżżejjed.
A protective response may not be induced in all vaccinees (see section 5.1).
Jista ’ ma jiġix ikkawżat rispons protettiv fil- vaċċini kollha (ara sezzjoni 5. 1).
4.5 Interactions with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
CELVAPAN should not be given at the same time as other vaccines.
CELVAPAN ma għandux jingħata fl- istess ħin ma ’ tilqim ieħor.
However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Madankollu, jekk jeħtieġ li jingħata flimkien ma ’ tilqima oħra, l- immunizzazzjoni għandha tingħata fuq dirgħajn / saqajn differenti.
It should be noted that the adverse reactions may be intensified.
Għandu jkun innotat li r- reazzjonijiet avversi jistgħu jkunu intensifikati.
Immunoglobulin is not to be given with CELVAPAN.
L- immunoglobulina m’ għandhiex tingħata ma ’ CELVAPAN.
If it is necessary to provide immediate protection, CELVAPAN may be given at the same time as normal or specific immunoglobulin.
Jekk ikun meħtieġ li tiġi pprovduta protezzjoni immedjata, CELVAPAN jista ’ jingħata fl- istess ħin ma ’ immunoglobulina normali jew speċifika.
Injections of CELVAPAN and immunoglobulin should be made into separate limbs.
L- injezzjonijiet ta ’ CELVAPAN u tal- immunoglobulina għandhom jingħataw f’ dirgħajn differenti.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Ir- rispons immunoloġiku jista ’ jkun imnaqqas jekk il- pazjent ikun qiegħed fuq trattament immunosuppressanti.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Wara t- tilqim kontra l- influwenza, kienu osservati riżultati pożittivi foloz f’ testijiet seroloġiċi li jużaw il- metodu ELISA biex jirrilevaw antikorpi kontra l- HIV1, l- Epatite Ċ u speċjalment l- HTLV1.
The Western Blot technique disproves the results.
It - teknika Western Blot twaqqa ’ dawn ir- riżultati.
The transient false positive reactions could be due to the IgM response by the vaccine.
Ir- reazzjonijiet pożittivi foloz temporanji jistgħu jkunu dovuti għar- rispons IgM mit- tilqima.
3 4.6 Pregnancy and lactation
3 4. 6 Tqala u treddigħ
Data from vaccinations with interpandemic trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Dejta minn tilqim b’ tilqim trivalenti interpandemiku f’ nisa tqal ma tindikax li r- riżultati avversi fil- feti u fl- omm kienu attribwibbli għat- tilqima.
Therefore, for pregnant women, administration of the pandemic influenza vaccine is recommended, irrespective of their stage of pregnancy.
Għalhekk, għal nisa tqal, l- għoti tat- tilqima kontra l- influwenza pandemika hu rakkomandat, irrispettivament mill- istadju li fih tkun it- tqala tagħhom.
The vaccine CELVAPAN may be used during lactation.
It- tilqima CELVAPAN tista ’ tintuża waqt it- treddigħ.
Some undesirable effects mentioned under section 4.8 such as dizziness and vertigo may affect the ability to drive or use machines.
Xi effetti mhux mixtieqa msemmija f’ sezzjoni 4. 8 bħal sturdament u vertiġini jistgħu jaffettwaw il- ħila biex issuq jew tħaddem il- magni.
In clinical trials with the mock-up vaccine (see section 5.1) in 606 subjects (326 between 18 and 59 years old, and 280 aged 60 and above), the following adverse reactions were assessed as at least possibly related by the investigator.
Fi provi kliniċi bit- tilqima finta (ara sezzjoni 5. 1) fuq 606 individwu (326 li kellhom bejn 18 u 59 sena, u 280 ta ’ 60 sena u aktar), ir- reazzjonijiet avversi li ġejjin kienu mill- anqas valutati mill - investigatur bħala li jistgħu jkunu relatati.
Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by influenza vaccines.
Ħafna mir- reazzjonijiet kienu ta ’ natura ħafifa, li jdumu ftit taż- żmien u kienu kwalitattivament simili għal dawk indotti minn tilqim ta ’ kontra l- influwenza.
There were fewer reactions after the second dose of the vaccine compared with the first dose.
Kien hemm inqas reazzjonijiet wara t- tieni doża tat- tilqima meta mqabbla mal- ewwel doża.
The most frequently occurring adverse reaction was injection site pain, which was usually mild.
L- aktar reazzjoni avversa li seħħet b’ mod frekwenti kien uġigħ fil- post tal- injezzjoni, li ġeneralment kien ta ’ natura ħafifa.
Adverse reactions are listed according to the following frequency.
Ir- reazzjonijiet avversi huma elenkati skont din il- frekwenza.
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Not known (cannot be estimated from the available data)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 sa < 1/ 10) Mhux komuni (≥1/ 1, 000 sa < 1/ 100) Rari (≥1/ 10, 000 sa < 1/ 1000) Rari ħafna (< 1/ 10, 000) Mhux magħruf (ma tistax tittieħed stima mid- data disponibbli)
Infections and infestations U
u infestazzjonijiet UInfezzjonijiet
Common: nasopharyngitis
Komuni: nasofarinġite
Blood and the lymphatic system disorders U
tad- demm u tas- sistema limfatika UDisturbi
Uncommon: lymphadenopathy
Mhux komuni: limfadenopatija
Psychiatric disorders U
psikjatriċi UDisturbi
Uncommon: insomnia, restlessness
Mhux komuni: nuqqas ta ’ rqad, irrekwitezza
Nervous system disorders U
fis- sistema nervuża UDisturbi
Common: headache, dizziness Uncommon: somnolence, dysaesthesia,
Komuni: uġigħ ta ’ ras, sturdament Mhux komuni: ngħas, disestesja
Eye disorders U
fl- għajnejn UDisturbi
Uncommon: conjunctivitis
Mhux komuni: konġuntivite
Ear and labyrinth disorders U
fil- widnejn u fis- sistema labirintika UDisturbi
Common: vertigo Uncommon: sudden hearing loss
Komuni: vertiġini Mhux komuni: telf tas- smigħ f’ daqqa
Vascular disorders U
vaskulari UDisturbi
Uncommon: hypotension
Mhux komuni: pressjoni baxxa
4 Common: pharyngolaryngeal pain Uncommon: dyspnoea, cough, rhinorrhoea, nasal congestion
4 respiratorji, toraċiċi u medjastinali UDisturbi
Gastrointestinal disorders U
gastrointestinali UDisturbi
Uncommon: gastro-intestinal symptoms (such as nausea, vomiting, diarrhoea and upper abdominal pain)
Mhux komuni: sintomi gastrointestinali (bħal dardir, rimettar, dijarea u wġigħ fil- parti ta ’ fuq tal- addome)
Skin and subcutaneous tissue disorders Common: hyperhidrosis Uncommon: rash, pruritus
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni: idrożi eċċessiva Mhux komuni: raxx, ħakk
Musculoskeletal and connective tissue disorders Common: arthralgia, myalgia
Disturbi muskolu- skeltrali u tal- connective tissue Komuni: artralġja, mijalġja
General disorders and administration site conditions Very common: injection site pain Common: pyrexia, chills, fatigue, malaise, induration, erythema, swelling and haemorrhage at the injection site Uncommon: injection site irritation
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Komuni ħafna: uġigħ fis- sit tal- injezzjoni Komuni: deni, sirdat, għeja, telqa, twebbis, eritema, nefħa u emorraġija fil- post tal- injezzjoni Mhux komuni: irritazzjoni fil- post tal- injezzjoni
Post-marketing surveillance
Sorveljanza ta ’ wara t- tqegħid fis- suq
For cell-based influenza vaccines, post-marketing surveillance data are not yet available.
Għal tilqim kontra l- influwenza bbażat fuq iċ- ċelluli, għad m’ hemmx tagħrif ta ’ wara t- tqegħid fis- suq disponibbli.
From post- marketing surveillance with egg-derived interpandemic trivalent vaccines, the following serious adverse reactions have been reported:
Minn sorveljanza ta ’ wara t- tqegħid fis- suq b’ tilqim trivalenti interpandemiku derivat mill- bajd, ġew irrapportati r- reazzjonijiet avversi serji li ġejjin:
Generalised skin reactions including pruritus, urticaria, and non-specific rash.
Reazzjonijiet ġeneralizzati tal- ġilda fosthom ħakk, urtikarja, u raxx mhux speċifiku.
Neuralgia, paraesthesia, convulsions, transient thrombocytopenia.
Newralġja, paraesteżija, konvulżjonijiet, tromboċitopenja temporanja.
Allergic reactions, in rare cases leading to shock, have been reported.
Ġew irrapportati reazzjonijiet allerġiċi, li f’ każijiet rari jwasslu għal xokk.
Vasculitis with transient renal involvement.
Vaskulite b’ involviment renali temporanju.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Disturbi newroloġiċi, bħal enċefalomajlite, nevrite u s- sindromu ta ’ Guillain Barré.
No case of overdose has been reported.
L- ebda każ ta ’ doża eċċessiva ma ġie rrappurtat.
Influenza vaccines, ATC Code J07BB01
Vaċċini kontra l- influwenza, Kodiċi ATC J07BB01
This section describes the clinical experience with the mock-up vaccine following a two-dose administration.
Din is- sezzjoni tiddeskrivi l- esperjenza klinika b’ tilqima finta wara għoti ta ’ żewġ dożi.
Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Tilqim finta fih antiġeni tal- influwenza li huma differenti minn dawk fil- virusijiet tal- influwenza li qegħdin jiċċirkolaw fil- preżent.
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Dawn l- antiġeni jistgħu jitqiesu bħala antiġeni ‘ ta ’ tip ġdid ’ u jissimulaw sitwazzjoni fejn il- popolazzjoni fil- mira għat- tilqima hija immunoloġikament inkonsapevoli.
Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Tagħrif miksub mat- tilqima finta tappoġġja strateġija ta ’ tilqim li x’ aktarx tintuża għat- tilqima ta ’ kontra l- pandemika: tagħrif dwar l- immunoġeniċità klinika, is- sigurtà u r- reazzjoni għal ġeni miksub b’ tilqim finta huwa relevanti għat- tilqim ta ’ kontra l- pandemija.
5 Immune response against the vaccine strain contained in CELVAPAN (A/ Vietnam/ 1203/ 2004)
5 Rispons immunitarju kontra r- razza tal- vaċċin li jinstab f’ CELVAPAN (A/ Vjetnam/ 1203/ 2004)
The immunogenicity of the 7.5 µg non-adjuvanted formulation of CELVAPAN (strain A/ Vietnam/ 1203/ 2004) has been evaluated in two clinical studies in adults aged 18 – 59 years (N=312) and in elderly subjects aged 60 years and older (N=272) following a 0, 21 day schedule.
L- immunoġeniċità tal- formulazzjoni mhux adjuvata ta ’ CELVAPAN ta ’ 7. 5 µg (razza A/ Vjetnam/ 1203/ 2004) ġiet evalwata f’ żewġ studji kliniċi fuq persuni adulti ta ’ bejn 18 – 59 sena (N=312) u fuq individwi anzjani ta ’ 60 sena u aktar (N=272) billi kienet segwita skeda ta ’ 0, 21 ġurnata.
After primary vaccination the seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in elderly subjects aged 60 years and above were as follows:
Wara l- ewwel tilqima, ir- rata ta ’ seroprotezzjoni, ir- rata ta ’ serokonverżjoni u l- fattur ta ’ serokonverżjoni għall- antikorp anti- HA kif imkejjel mill- emolisi radjali waħidha (SRH) f’ persuni adulti ta ’ bejn 18- 59 sena u f’ persuni anzjani li jkollhom 60 sena jew iżjed kienu hekk:
SRH Assay
Assaġġ SRH
18 – 59 years
18 – 59 sena 21 Jum Wara
60 years and above
60 sena u iżjed 21 Jum Wara
21 Days After
L- 1 Doża 55. 5%
21 Days After
It- 2 Doża 67. 7%
1st Dose
51. 3%
2nd Dose 1st Dose
62. 1% 52. 4%
2nd Dose
62. 4%
Seroprotection rate* Seroconversion rate** Seroconversion factor*** * SRH area > 25 mm²
Il- fattur ta ’ serokonverżjoni *** * arja SRH > 25 mm²
55.5% 51.3% 3.7
3. 7
65.4% 57.9% 62.1% 52.4% 4.8 3.6
4. 8 3. 6
67.7% 62.4% 4.6
4. 6
** either SRH area ≥ 25 mm2 if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
arja SRH ≥ 25 mm² jekk il- kampjun tal- linja bażi huwa negattiv jew żieda ta ’ 50% fl- arja SRH jekk il - ** kampjun tal- linja bażi > 4 mm² *** żieda fil- medja ġeometrika
After primary vaccination the rate of subjects with neutralizing antibody titres > 20, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in elderly subjects aged 60 years and above were as follows:
Wara l- ewwel tilqima, ir- rata ta ’ individwi b’ tajters ta ’ antikorpi li jinnewtralizzaw ta ’ > 20, rata ta ’ serokonverżjoni u fattur tas- serokonverżjoni kif imkejla mill- assaġġ tal- mikronewtralizzazzjoni (MN) f’ persuni adulti li jkollhom minn 18 sa 59 sena u f’ persuni anzjani li jkollhom 60 sena jew iżjed kienu kif ġej:
Microneutralisation assay
Assaġġ
18 – 59 years
18 – 59 sena
60 years and above
60 sena u iżjed
21 Days After
21 Jum Wara
Seroneutralisation rate*
Ir- rata ta ’ seronewtralizzazzjoni *
1st Dose 49.4%
L- 1 Doża 49. 4%
2nd Dose 1st Dose 73.0% 54.4%
It- 2 Doża L- 1 Doża 73. 0% 54. 4%
2nd Dose 74.1%
61. 9% 14. 3%
Seroconversion rate** Seroconversion factor*** * MN titre > 20
Il- fattur ta ’ serokonverżjoni *** * Tajter MN > 1: 20
39.1% 3.4
3. 4
61.9% 14.3% 4.7 2.1
4. 7 2. 1
26.7% 2.8
6 Rispons Immunitarju Inkroċjat Kontra Razez Relatati ta ’ H5N1
In the phase 3 study in adults (N=265) and elderly subjects (N=270) after vaccination with the A/ Vietnam/ 1203/ 2004 strain vaccine the rate of subjects with cross-neutralising antibodies as measured by MN (titre > 20) was as follows:
Fl- istudju ta ’ fażi 3 fuq persuni adulti (N=265) u persuni anzjani (N=270) wara tilqima bil- vaċċin bir- razza A/ Vjetnam/ 1203/ 2004, ir- rata ta ’ individwi b’ seroprotezzjoni għal antikorpi newtralizzanti inkroċjati kif imkejla mill- MN (tajter > 20) kienu hekk:
18 – 59 years a
18 – 59 sena a
60 years and above
60 sena u aktar
Day 42
Jum 42
Day 180
Jum 180
Day
Ir- rata ta ’
42 a Day 180
35. 1%
Tested against
14. 4% 54. 8%
Strain A/ Indonesia/ 05/ 2005
28. 0%
Seroneutralisation rate* * MN titre > 20 a 21 days after 2nd dose
seronewtralizzazzjoni * * tajter MN > 20 a 21 jum wara t- 2ni doża
In a dose-finding study in adults aged 18 – 45 years investigating various dose levels of adjuvanted and non-adjuvanted formulations of the A/ Vietnam/ 1203/ 2004 strain vaccine the rates of subjects with 6 neutralising antibody titres > 20, seroconversion rates and seroconversion factor for cross-neutralising antibodies as measured by MN in subjects who received the 7.5 µg non-adjuvanted formulation (N=42) were as follows:
Fi studju biex tinstab id- doża fuq persuni adulti ta ’ bejn 18 – 45 sena li investiga diversi livelli ta ’ doża tal- formulazzjonijiet adjuvati u mhux adjuvati tal- vaċċin bir- razza A/ Vjetnam/ 1203/ 2004 ir- rati ta ’ individwi li kisbu tajter ta ’ antikorpi li jinnewtralizzaw ta ’ > 20, ir- rati ta ’ serokonverżjoni u l- fattur ta ’ serokonverżjoni għal antikorpi newtralizzanti inkroċjati kif imkejla mill- MN f’ individwi li rċevew il - formulazzjoni mhux adjuvata ta ’ 7. 5 µg (N=42) kienu hekk:
Tested against
Ittestjat kontra
Strain A/ Indonesia/ 05/ 2005
Razza A/ Indonesja/ 05/ 2005
Day 42 a
Jum 42 a
Seroneutralisation rate* Seroconversion rate** Seroconversion factor*** * MN titre > 20
Il- fattur ta ’ serokonverżjoni *** * tajter MN > 20
45.2% 31.0% 3.2
3. 2
33.3% 21.4% 2.5
2. 5
** > 4-fold increase in MN *** geometric mean increase a 21 days after 2nd dose
** > żieda ta ’ 4 darbiet fit- tajter MN *** żieda fil- medja ġeometrika a 21 jum wara t- 2ni doża
Antibody Persistence and Booster Vaccination with Homologous and Heterologous Vaccine Strains
Persistenza tal- Antikorpi u Tilqima Booster b’ Razez Omologi u Eterologi tal- Vaċċin
Antibody persistence after vaccination with the 7.5 µg non-adjuvanted formulation of CELVAPAN (strain A/ Vietnam/ 1203/ 2004) has been evaluated in two clinical studies in adults aged 18 – 59 years (N=285) and in one clinical study in elderly subjects aged 60 years and above (N=258) up to 6 months after the start of the primary vaccination series.
Il- persistenza tal- antikorpi wara t- tilqima bil- formulazzjoni mhux adjuvata ta ’ 7. 5 µg ta ’ CELVAPAN (razza A/ Vjetnam/ 1203/ 2004) kienet evalwata f’ żewġ studji kliniċi f’ persuni adulti li kellhom 18 – 59 sena (N=285) u fi studju kliniku li sar fuq persuni anzjani li kellhom 60 sena jew iżjed (N=258) sa 6 xhur wara l- bidu tas- serje tat- tilqima primarja.
The results indicate an overall decline in antibody levels over time.
Ir- riżultati jindikaw tnaqqis globali fil- livelli tal- antikorpi mal- medda taż- żmien.
Data on later time points (months 12 and 24) are not yet available.
Dejta f’ time points iktar tard (wara 12 u 24 xahar) s’ issa mhijiex disponibbli.
Seroprotection*/
Seroprotezzjoni * /
Seroneutralisation rate** Month 6 * SRH area > 25 mm² ** MN titre > 20
Xahar 6 * erja SRH > 25 mm² ** tajter MN > 20
SRH Assay 28.1%
28. 1%
MN Assay SRH Assay 37.9% 26.7%
37. 9% 26. 7%
To date a booster vaccination with homologous and heterologous vaccine strains has been administered in the phase 3 study 6 months after primary vaccination with two doses of the A/ Vietnam/ 1203/ 2004 strain vaccine.
Sal- lum, tilqima booster b’ razez omologi u etorologi tal- vaċċin ingħatat fl- istudju ta ’ fażi 3, sitt xhur wara l- ewwel tilqima b’ żewġ dożi tal- vaċċin bir- razza A/ Vjetnam/ 1203/ 2004.
Two dose levels (3.75 µg and 7.5 µg) of both the A/ Vietnam/ 1203/ 2004 and A/ Indonesia/ 05/ 2005 strain vaccines were investigated for the booster vaccination.
Ġew investigati żewġ livelli ta ’ dożi (3. 75µg u 7. 5µg) tal- vaċċini kemm tar- razza A/ Vjetnam/ 1203/ 2004 u A/ Indonesja/ 05/ 2005 għat- tilqima booster.
Seroprotective titres as determined by SRH assay against the homologous vaccine strain (A/ Vietnam/ 1203/ 2004) were observed in 65.5% of subjects aged 18 – 59 years and in 59.4% of subjects aged 60 years and older at 21 days after a booster vaccination with the 7.5 μ g dose of the A/ Vietnam strain vaccine.
7 Tajters seroprotettivi kif determinati minn assaġġ SRH kontra r- razza omologa tal- vaċċin (A/ Vjetnam/ 1203/ 2004) kienu osservati f’ 65. 5% tal- individwi ta ’ 18 – 59 sena u f’ 59. 4% tal- individwi ta ’ 60 sena u aktar f’ jum 21 wara tilqima booster bid- doża ta ’ 7. 5 µg tal- vaċċin bir- razza A/ Vjetnam/ 1203/ 2004.
Twenty-one days after a booster vaccination with the 7.5 μ g dose of the A/ Indonesia/ 05/ 2005 strain vaccine a cross reactive response against the A/ Vietnam strain was obtained in 69.0% of subjects aged 18 – 59 years and in 40.6% of subjects aged 60 years and older.
Wieħed u għoxrin jum wara tilqima booster bid- doża ta ’ 7. 5 μg tat- tilqima tar- razza A/ Indonesja/ 05/ 2005, rispons cross- reattiv kontra r- razza A/ Vjetnam ġie miksub f’ 69. 0% tal - individwi ta ’ 18 – 59 sena u f’ 40. 6% tal- individwi ta ’ 60 sena u akbar.
Antibody responses as measured by MN 21 days after the booster vaccination were generally slightly higher with the A/ Indonesia/ 05/ 2005 than with the A/ Vietnam/ 1203/ 2004 strain vaccine.
Ir- risponsi tal- antikorpi kif imkejla minn MN 21 jum wara t- tilqima booster kienu ġeneralment ftit ogħla bit- tilqima tar- razza A/ Indonesja/ 05/ 2005 milli b’ dik b’ A/ Vjetnam/ 1203/ 2004.
Seroneutralisation rates (MN titre > 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/ Vietnam and A/ Indonesia vaccines, tested against both the homologous and heterologous strains were as follows:
Ir- rati tas- seronewtralizzazzjoni (tajter MN ta ’ > 20) 21 jum wara t- tilqima booster bid- doża ta ’ 7. 5 µg tat - tilqim A/ Vjetnam u A/ Indonesja, ittestjati kontra kemm razez omologi kif ukoll eterologi kienu kif ġej:
6-Month Booster
Booster ta ’ 6 xhur
Vaccination with 7.5 µg strain A/ Vietnam Tested against Seroneutralisation rate*
Tilqima b’ 7. 5 µg tar- razza A/ Vjetnam Ittestjati kontra Rata ta ’ seronewtralizzazzjoni *
A/ Vietnam 86.2%
A/ Vjetnam 86. 2%
A/ Indonesia A/ Vietnam 65.5% 64.5%
A/ Indonesja A/ Vjetnam 65. 5% 64. 5% Tilqima b’ 7. 5 µg tar- razza A/ Indonesja
A/ Indonesia 54.8%
A/ Indonesja 54. 8%
Vaccination with 7.5 µg strain A/ Indonesia Seroneutralisation rate* * MN titer > 1:20
Rata ta ’ seronewtralizzazzjoni * * Tajter MN > 1: 20
86.2%
86. 2%
65.6%
93. 1% 65. 6%
71.9%
71. 9%
Another study investigated a booster vaccination with 7.5 μ g of the heterologous A/ Indonesia/ 05/ 2005 vaccine strain administered 12 – 15 months after an initial 2-dose priming with various dose levels of adjuvanted and non-adjuvanted formulations of the A/ Vietnam/ 1203/ 2004 strain vaccine in subjects aged 18 – 45 years.
Studju ieħor stħarreġ it- tilqima booster b’ 7. 5 µg tar- razza etorologa tal- vaċċin A/ Indonesja/ 05/ 2005, mogħtija 12 – 15 - il xahar wara priming inizjali ta ’ żewġ dożi b’ diversi livelli ta ’ dożi tal- formulazzjonijiet adjuvati u mhux adjuvati tal- vaċċin bir- razza A/ Vjetnam/ 1203/ 2004 f’ individwi ta ’ 18 – 45 sena.
In subjects who received the 7.5 μ g non-adjuvanted formulation for primary vaccination (N = 12) seroprotection rates as measured by SRH 21 days after the booster vaccination were 66.7% and 83.3%, and 100% and 91.7% of subjects achieved neutralising antibody titres > 20 when tested against the homologous A/ Indonesia and the heterologous A/ Vietnam strain, respectively.
F’ individwi li rċevew il- formulazzjoni mhux adjuvata ta ’ 7. 5 µg għall - ewwel tilqima (N = 12) ir- rati tas- seroprotezzjoni kif imkejla minn SRH 21 jum wara t- tilqima booster kienu 66. 7% u 83. 3%, u 100% u 91. 7% ta ’ persuni li kisbu tajters ta ’ antikorpi li jinnewtralizzaw ta ’ > 20 meta ttestjati kontra r- razza omologa A/ Indonesja u r- razza eterologa A/ Vjetnam, rispettivament.
No clinical data have been generated in subjects below 18 years of age.
Ma ġiet iġġenerata l- ebda data klinika f’ individwi ta ’ inqas minn 18- il sena.
Information from non-clinical studies:
Informazzjoni minn studji li mhumiex kliniċi:
The protective efficacy of CELVAPAN against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian Influenza H5N1 virus was assessed non-clinically in a ferret challenge model.
L- effikaċja protettiva ta ’ CELVAPAN kontra morbożità u mortalità indotti mill- infezzjoni b’ dożi letali tal- virus patoġeniku ħafna tal- influwenza tat- tjur H5N1 ġiet valutata mhux klinikament f’ mudell ta ’ sfida fuq in- nemes.
Two studies have been performed using either the H5N1 A/ Vietnam/ 1203/ 2004 or the A/ Indonesia/ 05/ 2005 vaccine.
Saru żewġ studji billi ntużaw il- vaċċin H5N1 A/ Vjetnam/ 1203/ 2004 jew A/ Indonesja/ 05/ 2005.
In one study, sixteen ferrets were divided into two cohorts and were vaccinated on days 0 and 21 with 7.5 µg of the A/ Vietnam/ 1203/ 2004 vaccine or were sham vaccinated.
Fi studju minnhom, sittax- il nemes ġew maqsuma f’ żewġ gruppi u ngħataw tilqima f’ jum 0 u 21 b’ 7. 5 µg tal- vaċċin A/ Vjetnam/ 1203/ 2004 jew ingħataw tilqima finta.
All ferrets were challenged intranasally on day 35 with a high dose of the highly virulent H5N1 virus strain A/ Vietnam/ 1203/ 2004 and monitored for 14 days.
Fil- 35 jum, l- inmsa kollha ġew sfidati mill- imnieħer b’ doża qawwija tar- razza virulenti ħafna tal- virus H5N1, A/ Vjetnam/ 1203/ 2004, u mmonitorjati għal 14- il jum.
Ferrets vaccinated with the 7.5 µg dose of the A/ Vietnam/ 1203/ 2004 vaccine demonstrated a high rate of seroconversion.
L- inmsa imlaqqma bid- doża ta ’ 7. 5 µg tal- vaċċin A/ Vjetnam/ 1203/ 2004 urew rata għolja ta ’ serokonverżjoni.
The A/ Vietnam/ 1203/ 2004 vaccine afforded protection against homologous challenge as evidenced by full survivorship, reduced weight loss, a less pronounced and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control animals.
Il- vaċċin A/ Vjetnam/ 1203/ 2004 offra protezzjoni kontra sfida omologa kif muri minn sopravivenza sħiħa, tnaqqis fit- telf tal- piż, żieda inqas evidenti u iqsar fit- temperatura, tnaqqis inqas notevoli fl- għadd ta ’ limfoċiti u fit- tnaqqis tal- infjammazzjoni u n- nekrożi fil- moħħ u fil- basla olfattorja fil- koorti mlaqqma meta pparagunat mal- annimali ta ’ kontroll.
All controls animals succumbed to the infection.
L- annimali ta ’ kontroll kollha ċedew għall- infezzjoni.
In a second study, sixty-six ferrets were divided into 6 cohorts of 11 ferrets and were immunized on days 0 and 21 with 3.75 µg or 7.5 µg of the Indonesia vaccine or were sham vaccinated.
8 Fi studju ieħor, sitta u sittin nemes ġew maqsuma f’ 6 koorti ta ’ 11- il nemes u ġew imlaqqma f’ jum 0 u l- 21 jum bi 3. 75µg jew 7. 5µg tal- vaċċin tal- Indoneżja jew ingħataw tilqima finta.
The ferrets were challenged intranasally on day 35 with a high dose of either the clade 2 H5N1 virus A/ Indonesia/ 05/ 2005 or the clade 1 H5N1 virus A/ Vietnam/ 1203/ 2004 and monitored for 14 days.
F’ jum 35, l- inmsa ġew sfidati mill- imnieħer b’ doża qawwija jew virus tal- clade 2 H5N1 A/ Indonesja/ 05/ 2005 jew virus tal- clade 1 H5N1 A/ Vjetnam/ 1203/ 2004 u ġew immonitorjati għal 14- il ġurnata.
The A/ lndonesia/ 05/ 2005 vaccine was shown to be efficacious with 100% survival, reduced incidence of fever, reduced weight loss, reduced virus burden, and reduced haematological (leukopenia and lymphopenia) changes in the vaccinated cohorts following homologous challenge.
Il- vaċċin A/ lndonesja/ 05/ 2005 intwera li kien effikaċi b’ sopravivenza ta ’ 100%, tnaqqis fl- inċidenza tad- deni, tnaqqis fit- telf tal- piż, tnaqqis fit- tagħbija tal- virus, u tnaqqis fil- bidliet ematoloġiċi (lewkopenija u limfopenija) fil- gruppi mlaqqma wara sfida omologa.
Similarly, the A/ lndonesia/ 05/ 2005 vaccine was efficacious against a heterologous challenge, showing a vaccine dose dependent survivorship in the vaccinated cohorts as compared to the control cohort.
Bl- istess mod, il- vaċċin A/ lndonesja/ 05/ 2005 kien effikaċi kontra sfida eterologa, u wera sopravivenza relatata mad- doża tal- vaċċin fil- gruppi mlaqqma meta pparagunat mal- grupp ta ’ kontroll.
Similar to the homologous challenge, vaccination against a heterologous challenge reduced virus burden, and reduced haematological (leukopenia) changes associated with highly pathogenic avian influenza infection.
Bħall- isfida omologa, it- tilqima kontra sfida eterologa naqqset it- tagħbija tal- virus, u naqqset il- bidliet ematoloġiċi (lewkopenija) assoċjati ma ’ infezzjoni patoġenika ħafna tal- influwenza tat- tjur.
Non-Clinical studies demonstrated alterations in liver enzymes and calcium levels in repeat dose toxicity studies in rats.
Studji li mhumiex kliniċi wrew bidliet fl- enzimi tal- fwied u l- livell tal- kalċju fi studji dwar l- effett tossiku minn dożi ripetuti fil- firien.
Such alterations in liver function have not been seen to date in human clinical studies.
Sal- lum bidliet bħal dawn fil- funzjoni tal- fwied ma dehrux fi studji kliniċi fuq il- bnedmin.
Alterations in calcium metabolism have not been examined in human clinical studies.
It- tibdil fil- metaboliżmu tal- kalċju ma ġiex eżaminat fi studji kliniċi fuq il- bnedmin.
As of yet data from non-clinical studies concerning reproduction and development are not available.
Sal- lum għad m’ hemmx informazzjoni disponibbli minn studji li mhumiex kliniċi fir- rigward tar- riproduzzjoni u l- iżvilupp.
8 6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi
Trometamol Sodium chloride Water for injections Polysorbate 80
Trometamol Sodium chloride Ilma għall- injezzjonijiet Polysorbate 80
1 year After first opening, the product should be used immediately.
Sena Wara li jinfetaħ, il- prodott għandu jintuża immedjatament.
However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature.
Madankollu, l- istabbiltà kimika u fiżika waqt l- użu kienet murija għal 3 sigħat fit- temperatura tal- kamra.
Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2°C – 8°C).
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
6.5 Nature and contents of the container
9 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber)
Pakkett wieħed ta ’ 20 kunjett b’ ħafna dożi (ħġieġ ta ’ Tip I) ta ’ 5 ml ta ’ suspensjoni (10 dożi x 0. 5 ml) b’ tapp (lastku bromobutyl)
The vaccine should be allowed to reach room temperature before use.
It- tilqima għandha titħalla tilħaq it- temperatura ambjentali qabel tintuża.
Shake before use.
Ħawwad qabel l- użu.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Kull doża tat- tilqima ta ’ 0. 5 ml tinġibed ġo siringa għall- injezzjoni.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
MARKETING AUTHORIZATION HOLDER
ID- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Baxter AG Industriestrasse 67 A- 1221 Vienna L- Awstrija
MARKETING AUTHORISATION NUMBER
NUMRU( I) TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DATA TAL- EWWEL AWTORIZZAZZJONI/ TIĠDID TAL- AWTORIZZAZZJONI