qanastek/EMEA-V3 huggingface dataset:
273 direction until the dose arrow is pointing to the dose you require (The black dosage dial lets you set the dose in steps of 37.5 IU.
Tissettja d- doża: issettja d- dosa li għandek bżonn billi ddawwar il- kwadrant iswed tad- doża f’ kwalunkwe direzzjoni, sakemm il- vleġġa tad- doża qedgħha fuq id- doża li għandek bżonn (il- kwadrant iswed tad- doza jħallik tissettja d- doza f’ passi ta ’ 37. 5 IU.
The minimum dose and the maximum dose that you can set are respectively equal to 37.5 IU and 450 IU).
Id- doza minima u massimu li tista tissetja huma ta ’ 37. 5 IU u 300 IU, rispettivament.) Ta ’ darba li ssettjat id- doza, ppreparah billi tiġbed lill- barra l- buttuna ta ’ l- injezzjoni sakemm tista.
The red dosage control scale on the injection button enables you to check whether the last dose will be complete or not.
Il - kontroll kwadrant aħmar tad- doża fuq il- buttuna ta ’ l- injezzjoni tħallik tiċċekja jekk l- aħħar doza tkun kompleta jew le.
These problems may effect more than 10 patients out of 100 treated.
268 Dawn l- effetti jistgħu jaffetwaw iktar minn 10 pazienti minn 100 li qegħdin jieħdu l- kura.
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see also section 2) can occur (between 1 and 10 patients out of 100 treated patients).
Wara li tingħata l- kura permezz ta ’ GONAL- f, meta tittieħed l- gonadotrofina korjonika umana, tista ’ sseħħ il- kundizzjoni magħrufa bħala s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji (ara sezzjoni 2) (bejn 1 u 10 minn 100 pazienti li qegħdin jieħdu l- kura).
275 Side effects in men Men may experience some breast development, acne or weight gain due to treatment with hCG (between 1 and 10% of the patients).
L- irġiel jistgħu jesperjenzaw xi żvilupp tas- sider, akne jew żieda fil- piż minħabba l- kura bl- hCG bejn 1 u 10% mill- pazienti).
Some men undergoing treatment with GONAL-f may experience local reactions at the injection site (pain, redness, bruising, swelling and/ or irritation) or may develop a varicocele (swelling of the veins above and behind the testicle).
Xi irġiel li qegħdin jieħdu din il- kura ta ’ GONAL- f jistgħu jesperjenzaw reazzjonijiet lokali fis- sit ta ’ l- injezzjoni (uġigħ, ħmura, tbenġil, nefħa u/ jew irritazzjoni) jew jizviluppaw varicocele (nefħa tal- vini fuq u wara t- testikolu)..
Within its shelf life, the product may be stored at or below 25°C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months.
Sad- data ta ’ meta jiskadi, il- prodott jista ’ jinħażen f’ temperauta ta ’ 25°C jew inqas sa tlett xhur mingħajr ma jitpoġġa fil- friġġ u għandu jintrema ’ jekk ma jintuzax wara tlett xhur,
Once opened, the product may be stored for a maximum of 28 days at or below 25°C.
Darba miftuħ, il - prodott jista ’ jinħazen għal mhux iktar minn 28 ġurnata, f’ temperatura ta ’ 25°C jew inqas.
The solution should not be administered if it contains particles or is not clear.
269 Is- soluzzjoni rikostitwita m’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara.
Each cartridge delivers 900 IU (equivalent 66 micrograms) in 1.5 ml.
Kull skartoċċ jagħti 300 IU (ekwivalenti għal 22 micrograms) fi 0. 5 ml.
It is supplied in packs of 1 pre-filled pen and 14 needles for administration.
Il- prodott jiġi f’ pakketti ta ’ pinna mimlija lesta u 5 labar għal amministrazzjoni.
276 Marketing Authorisation Holder
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Č eská republika Merck spol. s. r. o Zdě bradská 72 CZ-251 01 Ř íč any- Jaž lovice Tel. +420 323619211
270 Česká republika Merck spol. s. r. o Zděbradská 72 CZ- 251 01 Říčany - Jažlovice Tel. +420 323619211
Ísland Gróco ehf.
271 Ísland Gróco ehf.
PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS
RAPPORT TA 'VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) VAĊĊIN KONTRA L- INFLUWENZA PANDEMIKA (H5N1) (SPLIT VIRION, INATTIVA, INĠUVANIT) GLAXOSMITHKLINE BIOLOGICALSSommarju tal- EPAR għall- pubbliku
What is ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals’? ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ is a vaccine that is given by injection.
Il- vaċċin kontra ‘ L- influwenza pandemika (H5N1) (split virion, inattiva, inġuvanit) Glaxosmithkline Biologicals ’ huwa vaċċin li jingħata permezz ta ’ injezzjoni.
It contains parts of influenza (flu) viruses that have been inactivated (killed).
Fih partijiet ta ’ vajrusis ta ’ l- influwenza li ġew diżattivati (maqtula).
The vaccine contains a flu strain called ‘ A/ VietNam/ 1194/ 2004 NIBRG-14’ (H5N1).
Il- vaċċin fiha r- razza ta ’ l- influwenza msejħa ‘ A/ Viet Nam/ 1194/ 2004 NIBRG- 14 ’ (H5N1).
This vaccine is the same as Prepandrix, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal- Prepanderix, li hija diġà awtorizzata fl- Unjoni Europea (UE).
The company that makes Prepandrix has agreed that its scientific data can be used for this vaccine.
Il - kumpanija li tagħmel Prepandrix qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal dan il - vaċċin.
What is the vaccine used for? ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ is a vaccine for use in adults aged between 18 and 60 years to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Il- vaċċin kontra ‘ L- influwenza pandemika (H5N1) (split virion, inattiva, inġuvanit) Glaxosmithkline Biologicals ’ huwa vaċċin għall- użu f’ adulti ta ’ etajiet bejn it- 18 u s- 60 sena għal protezzjoni kontra l - influwenza kkawwżata mir- razza H5N1 (tip) ta ’ vajrus ta ’ l- influwenza tat- tip A.
The vaccine is given according to official recommendations.
Il- vaċċin jiġi mogħti skond ir- rakkommandazzjonijiet uffiċjali.
The vaccine can only be obtained with a prescription.
Il- mediċina tista 'tinkiseb biss b' riċetta tat- tabib.
How is the vaccine used?
Kif jintuża l- vaċċin?
The vaccine is given by injection into the upper arm muscle in two doses, at least three weeks apart.
Il- vaċċin jingħata b’ injezzjoni fil- muskolu tal- parti ta ’ fuq tad- driegħ f’ żewġ dożi, mill- anqas bi tliet ġimgħat bejniethom.
How does the vaccine work? ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ is a ‘ prepandemic’ vaccine.
Il- vaċċin kontra ‘ L- influwenza pandemika (H5N1) (split virion, inattiva, inġuvanit) Glaxosmithkline Biologicals ’ huwa vaċċin ‘ prepandemiku ’.
This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
Hemm vaċċin speċjali li huwa intiż għal protezzjoni lontra linja ta ’ influenza li tista ’ tikkawża pandemia fil- futur.
A flu pandemic happens when a new 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 ta ’ l- 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.
Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
Esperti tas- saħħa huma konċernati li l- influwenza pandemika li jmiss tista ’ tiġi kkawwżata minn linja ta ’ H4N1 tal- vajrus.
The vaccine has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.
Il- vaċċin ġie żviluppat sabiex jipprovdi protezzjoni kontra dan it- tip, sabiex ikun jista ’ jintuża qabel jew matul il- pandemija ta ’ l - influwenza.
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 l- mard.
This vaccine contains small amounts of haemagglutinins (proteins from the surface) of the H5N1 virus.
Il- vaċċin fih ammonti żgħar ta ’ ħemaglutinins (proteini mill- wiċċ) ta ’ vajrus imsemmi H5N1.
The virus has first been inactivated (killed) so that it does not cause any disease.
Il- virus l- ewwel ġie inattivat (maqtul) sabiex ma jikkaġuna l- ebda mard.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Meta 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. persuna tingħata l- vaċċin, is- sistema immunitarja tagħraf lill- virus bħala “ barrani ” u tagħmel antikorpi kontrih.
When a person is given the vaccine, the immune system recognises the virus as ‘ foreign’ and makes antibodies against it.
Is- sistema immunitarja imbagħad tkun tista ’ tagħmel antikorpi aktar malajr meta terġa ’ tkun esposta għal virus darb’ oħra.
This may help to protect against the disease caused by the virus.
Dan jgħin fil- protezzjoni kontra l- marda kkawwżata minn vajrus.
Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with an emulsion.
Qabel l- użu, il- vaċċin isir minn tahlita ta ’ sospensjoni li fiha l- partiċelli tal- vajrus flimkien ma ’ emulsjoni.
The resulting ‘ emulsion’ is then injected.
L - ‘ emulsjoni ’ riżultanti imbagħad tiġi injettata.
The emulsion contains an ‘ adjuvant ’ (a compound containing oil) to stimulate a better response.
L- emulsjoni fiha wkoll adjuvant (taħlita li fiha ż- żejt) biex jistimola reazzjoni aħjar.
How has the vaccine been studied?
Kif ġie studjat il- vaċċin?
The effects of the vaccine were first tested in experimental models before being studied in humans.
L- effetti tal- vaċċin għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ’ ġew studjati fil - bniedem.
The main study of the vaccine included 400 healthy adults and compared the ability of different doses of the vaccine, with or without the adjuvant, to trigger the production of antibodies (‘ immunogenicity’).
L- istudju prinċipali tal- vaċċin inkluda 400 adult b’ saħħithom u pparaguna mal- kapaċità ta ’ dożi differenti ta ’ Pandemrix, b’ adjuvant jew mingħajru, jqanqal il- produzzjoni ta ’ antikorpi (‘ immunoġeniċiti ’).
The participants received two injections of the vaccine containing one of four different doses of haemagglutinin.
Il- parteċipanti rċevew żewġ injezzjonijiet tal- vaċċin li fihom doża waħda minn erba ’ differenti ta ’ emoglutinins.
The injections were given 21 days apart.
L- injezzjonijiet ġew mogħtija b’ 21 jum separatament.
The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Qabel il- vaċċinazzjoni, fil- jum tat- tieni vaċċinazzjoni (jum 21) u 21 jum wara (jum 42).
Additional studies were used to support the main study and to demonstrate the vaccine’ s safety.
Studji addizzjonali intużaw sabiex isostnu l- istudju prinċipali u sabiex juru s- sigurtà tal- vaċċin.
What benefit has the vaccine shown during the studies?
Liema benefiċċju wera l- vaċċin waqt l- istudji li ġew mwettqa?
According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a prepandemic 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’ għallinqas 70% tal- persuni biex jitqies stabbli.
The main study showed that the vaccine containing 3.75 micrograms of haemagglutinin and the adjuvant produced an antibody response that met these criteria.
L- istudju prinċipali wera li l- vaċċin fih 3. 75 mikrogrammi ta ’ emoglutinins u l- adjuvant ipproduċa reazzjoni b’ antikorp li ssodisfa dawn il- kriterji.
At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Wara 21 jum wara t- tieni injezzjoni, 84% tan- nies li irċevew il- vaċċin kellhom livelli ta ’ antikorpi li jistgħu jipproteġuhom kontra l- H5N1.
What is the risk associated with the vaccine?
X’ inhu r- riskju assoċjat mal- vaċċin?
The most common side effects with ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals’ (occurred with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
L- aktar effetti sekondarji tal - ‘ Vaċċin kontra l- influwenza pandemika (H5N1) (split virion, inattiva, inġuvanit) Glaxosmithkline Biologicals ’ huwa (ġraw f’ doża waħda minn għaxra jew aktar tal- vaċċin) huma uġiegħ ta ’ ras, artralġja (uġiegħ fil- ġogi), majalġja (uġiegħ fil- ġogi), reazzjonijiet fis- sit ta ’ l - injezzjoni (ebusija, nefħa, uġiegħ u ħmura), deni u għejja (ħeddla).
For the full list of all side effects reported with the vaccine, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati dwar il- vaċċin, ara l- Fuljett ta ’ Tagħrif.
The vaccine 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 eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Il- vaċċin m’ għandux jingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill- komponenti tal- vaċċin, jew għal kwalunkwe sustanza li tinsab f’ livelli ta ’ traċċi, bħal bajd, proteina tat- tiġieġ, ovalbumin (proteina fl- abjad tal- bajd), formaldehyde, gentamicin sulphate (antibijotiku) u sodium deoxycholate..
Vaccination should be delayed in people who have a sudden fever.
Il- vaċċin għandu jiġi mogħti aktar tard lil persuni li jaqbadhom deni f’ daqqa.
Why has the vaccine been approved?
Għaliex ġie approvat il- vaċċin?
The CHMP decided that the benefits of ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ are greater than its risks for active immunisation against H5N1 subtype of influenza A virus.
Is- CHMP ddeċieda li l- benefiċċji tal- vaċċin kontra ‘ l- influwenza pandemika (H5N1) (split virion, inattiva, inġuvanit) Glaxosmithkline Biologicals’ huwa huma aktar mir- riskji tiegħu għal immunizzazzjoni attiva kontra l- H5N1 ta ’ influwenza tal- vajrus tip A.
The Committee recommended that the vaccine be given marketing authorisation.
Il- Kumitat irrakkomanda li l - vaċċin jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about the vaccine:
Informazzjoni oħra dwar il- vaċċin:
The European Commission granted a marketing authorisation valid throughout the EU for ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ to GlaxoSmithKline Biologicals S. A. on 26 September 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal vaċċin kontra ‘ l- influwenza pandemika (H5N1) (split virion, inattiva, inġuvanit) Glaxosmithkline Biologicals ’ lil GlaxoSmithKline Biologicals S. A. fis - 26 Settembru 2008.
The full EPAR for the vaccine can be found here.
L- EPAR sħiħ għal vaċċin jista ’ jiġi kkonsultat hawnhekk.
Package size
Suspensjoni u
suspension (H5N1): vial (glass)
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals
2.5 ml (suspension)
emulsjoni għal emulsjoni għall - injezzjoni
50 vials (suspension)
Użu għal ġol - muskolu
vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmith Kline Biologicals
emulsjoni: kunjett (ħġieġ); suspensjoni: kunjett (ħġieġ)
emulsion for injection
suspensjoni:
emulsion (adjuvant): vial (glass)
2. 5 ml; emulsjoni:
2.5 ml (emulsion)
2. 5 ml
2 x 25 vials (emulsion)
50 kunjett (suspensjoni) + 2 x 25 kunjett (emulsjoni)
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection.
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat)
After mixing, 1 dose (0.5 ml) contains:
Wara li titħallat, doża waħda (0. 5 ml) ikun fiha:
Split influenza virus inactivated, containing antigen* equivalent to:
Virus maqsum, mhux attivat ta ’ l- influwenza li jkun fih antiġen * ekwivalenti għal:
A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14) * propagated in eggs ** haemagglutinin
3. 75 mikrogrammi ** Razza tixbaħ A/ VietNam/ 1194/ 2004 (H5N1) użat (NIBRG- 14) * imnissla fil- bajd ** emagglutinina
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams)
Suppliment AS03 magħmul minn squalene (10. 68 milligrammi), DL- α- tocopherol (11. 86 milligrammi) u polysorbate 80 (4. 85 milligrammi)
The suspension and emulsion vials once mixed form a multidose container.
Il- kunjetti tas- suspensjoni u l- emulsjoni ladarba jitħalltu jipproduċu kontenitur b’ ħafna dożi.
See section 6.5 for the number of doses per vial.
Ara sezzjoni 6. 5 għan- numru ta ’ dożi li fih kull kunjett.
It contains 5 micrograms thiomersal
Fih 5 mikrogrammi thiomersal
For a full list of excipients see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Suspension and emulsion for emulsion for injection.
Suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni.
The suspension is a colourless light opalescent liquid.
Is- suspensjoni hija likwidu bla kulur, ċar ikanġi.
The emulsion is a whitish homogeneous liquid.
L- emulsjoni hija likwidu omoġenju bajdani.
Active immunisation against H5N1 subtype of Influenza A virus.
Tilqim attiv kontra sottotip H5N1 tal- virus ta ’ l- Influwenza A.
This indication is based on immunogenicity data from healthy subjects aged 18-60 years following administration of two doses of vaccine prepared from A/ VietNam/ 1194/ 2004 NIBRG-14 (H5N1) (see section 5.1).
Din l- indikazzjoni hija bbażata fuq dejta ta ’ immunoġeniċità minn individwi b’ saħħithom ta ’ età bejn it- 18- 60 sena wara amministrazzjoni ta ’ żewġ dożi ta ’ vaċċin ippreparati minn A/ VietNam/ 1194/ 2004 NIBRG- 14 (H5N1) (ara sezzjoni 5. 1).
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg għandu jintuża skond gwida uffiċjali.
1 dose of 0.5 ml at an elected date.
Adulti mill- età ta ’ 18 sa 60 sena: doża 1 ta ’ 0. 5 ml f’ data magħżula.
A second dose of vaccine should be given after an interval of at least three weeks.
It- tieni doża tal- vaċċin għandha tingħata wara intervall ta ’ mill- anqas tliet ġimgħat.
There is no experience in children and adults above 60 years of age.
M’ hemm l- ebda esperjenza fit- tfal u fl- adulti li għandhom ’ il fuq minn 60 sena.
2 For further information, see section 5.1.
2 Għal aktar tagħrif, ara sezzjoni 5. 1.
Immunisation should be carried out by intramuscular injection.
It- tilqim għandu jsir b’ injezzjoni fil- muskolu.
History of an anaphylactic (i. e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Storja ta ’ reazzjoni anafilattika (i. e. li tista ’ twassal għall- mewt) għal xi wieħed mill- kostitwenti jew traċċi ta ’ residwi (proteina tal- bajd u tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate) ta ’ dan il- vaċċin.
See sections 4.4, 4.8 and 6.1.
Ara sezzjonijiet 4. 4, 4. 8 and 6. 1.
Acute severe febrile illness.
Mard akut b’ deni qawwi.
Immunisation should be postponed.
It- tilqim għandu jiġi pospost.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Għandha tingħata attenzjoni meta l- vaċċin jingħata lil persuni b’ sensittivita` eċċessiva magħrufa (għajr reazzjoni anafilattika) għas- sustanza attiva, għal xi wieħed mis- sustanzi mhux attivi, għal thiomersal u għar- residwi (proteina tal- bajd u tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate).
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 fil każ tal- vaċċini injettabbli kollha kura u sorveljanza medika xierqa għal xi każ rari anafilattiku wara li jingħata l- vaċċin għandha tkun dejjem disponibbli.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should under no circumstances be administered intravascularly or intradermally.
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg m’ għandu qatt jingħata b’ mod intravaskulari jew ġol- ġilda.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Ir- respons ta ’ antikorpi f’ pazjenti b’ immunosoppressjoni endoġenja jew iatroġenika jista ’ ma jkunx biżżejjed.
A protective immune response may not be elicited in all vaccinees (see section 5.1).
Respons immuni ta ’ protezzjoni jista ’ ma jirriżultax f’ kull minn jieħu l- vaċċin (ara sezzjoni 5. 1).
The vaccine should not usually be given at the same time as other vaccines.
Ġeneralment il- vaċċin m’ għandux jingħata fl- isess ħin ma ’ vaċċini oħra.
However, if co- administration with another vaccine is considered to be essential, the vaccines should be injected into separate limbs.
Madankollu, jekk l - amministrazzjoni tiegħu ma ’ vaċċin ieħor tkun ikkunsidrata essenzjali, il- vaċċini għandhom jiġu injettati fi driegħ jew sieq differenti.
It should be noted that the adverse reactions may be intensified.
Wieħed għandu jkun jaf li reazzjonijiet avversi jistgħu jkunu aktar qawwija.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Ir- respons immunoloġiku jista ’ jonqos jekk il- pazjent ikun qed jingħata xi kura immunosoppressiva.
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Wara tilqim għall- influwenza, jistgħu jinkisbu riżultati pożittivi foloz f’ testijiet seroloġiċi bl- użu tal - metodu ELISA għal antikorpi tal- virus- 1 ta ’ l- immunodefiċjenza umana (HIV- 1), tal- virus ta’ l- epatite C u speċjalment ta ’ l- HTLV- 1.
In such cases, the Western blot method is negative.
F’ każijiet bħal dawn il- metodu Western blot huwa negattiv.
These transitory false-positive results may be due to IgM production in response to the vaccine.
Dawn ir - riżultati pożittivi foloz li jgħaddu malajr jistgħu jkunu minħabba l- produzzjoni ta ’ l- IgM bħala respons għall- vaċċin.
No data have been generated in pregnant women with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg or with any other vaccine that contains the AS03 adjuvant.
Ma ħarġet l- ebda dejta f’ nisa tqal dwar Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg jew dwar kwalunkwe vaċċin ieħor li fih is- suppliment AS03.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/ foetal development, parturition or post-natal development (see section 5.3).
Studji fl- annimali ma jurux effetti ħżiena diretti jew indiretti fuq il- fertilità, fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju/ fetu, ħlas jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
Healthcare providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
3 Dawk li jieħdu ħsieb il- kura tas- saħħa jkollhom bżonn jevalwaw il- benefiċċji u r- riskji possibbli involuti meta jagħtu l- vaċċin lil nisa tqal waqt li jikkunsidraw ir- rakkomandazzjonijiet uffiċjali.
3 There are no data regarding the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
M’ hemm l- ebda dejta dwar l- użu ta ’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg waqt it- treddigħ.
The potential benefits to the mother and risks to the infant should be considered before administering Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
Il- benefiċċji li jista ’ jkun hemm għall- omm u r- riskji għat- tarbija għandhom jiġu kkunsidrati qabel jingħata Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg waqt it- treddigħ.
Some of the effects mentioned under section 4.8 “ Undesirable Effects” may affect the ability to drive or operate machinery.
Xi wħud mill- effetti msemmija fis- sezzjoni 4. 8 “ Effetti mhux mixtieqa ” jista ’ jkollhom effett fuq il - ħila li ssuq u tħaddem magni.
The incidence of adverse reactions has been evaluated in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/ AS03.
L- inċidenza ta ’ reazzjonijiet avversi ġiet evalwata f’ bejn wieħed u ieħor 5, 000 individwu ta ’ 18- il sena jew aktar li rċievew formulazzjonijiet li kien fihom mill- anqas 3. 75 mikrogrammi HA/ AS03.
Adverse reactions reported are listed according to the following frequency:
Reazzjonijiet avversi rrappurtati huma elenkati skond il- frekwenza li ġejja:
Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100) Rare (≥ 1/ 10,000 to < 1/ 1,000) Very rare (< 1/ 10,000)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 sa < 1/ 10) Mhux komuni (≥1/ 1, 000 sa < 1/ 100) Rari (≥1/ 10, 000 sa < 1/ 1, 000) Rari ħafna (< 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 mniżżla skond is- serjetà tagħhom fejn l - effetti l- aktar serji huma mniżżla l- ewwel, segwiti minn dawk anqas serji.
Blood and lymphatic system disorders Common: lymphadenopathy
Disturbi tad- demm u tas- sistema limfatika Komuni: limfadenopatija
Nervous system disorders Very common: headache Uncommon: paraesthesia, somnolence, dizziness
Disturbi fis- sistema nervuża Komuni ħafna: uġigħ ta ’ ras Mhux komuni: parestesija, ħeddla tan- ngħas, sturdament
Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Disturbi gastro- intestinali Mhux komuni: sintomi gastro- intestinali (bħal dijarea, rimettar, uġigħ addominali, dardir)
Skin and subcutaneous tissue disorders Common: ecchymosis at the injection site, sweating increased Uncommon: pruritus, rash
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni: ekkimosi fis- sit ta ’ l- injezzjoni, żieda fil- ħruġ ta ’ għaraq Mhux komuni: ħakk, raxx
Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Disturbi muskolu- skeletrali u tal- connective tissue Komuni ħafna: artralġja, mijalġja
General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Komuni ħafna: ebusija tal- ġilda, nefħa, uġigħ u ħmura fis- sit ta ’ l- injezzjoni, deni, għeja Komuni: tregħid, mard bħal ta ’ l- influwenza, reazzjonijiet fis- sit ta ’ l- injezzjoni (bħal sħana, ħakk) Mhux komuni: telqa
Psychiatric disorders Uncommon: insomnia
Disturbi psikjatriċi Mhux komuni: insomnja
• Post-marketing surveillance
4 • Sorveljanza ta ’ wara t- tqegħid fis- suq
4 No post-marketing surveillance data are available following Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg administration.
L- ebda dejta ta ’ sorveljanza ta ’ wara t- tqegħid fis- suq m’ hija disponibbli wara li ngħata Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg.
From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Minn sorveljanza ta ’ wara t- tqegħid fis- suq fuq vaċċini trivalenti interpandemiċi, ir- reazzjonijiet avversi li ġejjin kienu rrappurtati:
Generalised skin reactions including urticaria
Reazzjonijiet ġenerali fil- ġilda inkluż urtikarja
Neuralgia, convulsions, transient thrombocytopenia.
Newralġja, aċċessjonijiet, tromboċitopenja li tgħaddi.
Allergic reactions, in rare cases leading to shock, have been reported.
Reazzjonijiet allerġiċi, f’ każi rari jwasslu għal xokk, kienu rrappurtati.
Vasculitis with transient renal involvement.
Vaskulite b’ involviment tal- kliewi li jgħaddi.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Mard newroloġiku, bħal enċefalomajelite, newrite u s- sindrome ta ’ Guillain Barré.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Dan il- prodott mediċinali fih thiomersal (prodott organomerkuriku) bħala preservattiv u għalhekk hemm il- possibilta` ta ’ reazzjonijiet ta ’ sensittivita` (ara sezzjoni 4. 4).
Influenza vaccines, ATC Code J07BB02
Vaċċini ta ’ l- influwenza, Kodiċi ATC J07BB02
Immune response against vaccine strain contained in Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
Respons immuni kontra r- razza tal- vaċċin li hemm f’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg:
In a consistency study, more than 900 subjects aged 18-60 years received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg following a 0, 21 days schedule.
Fi studju ta ’ konsistenza, aktar minn 900 individwu li għandhom età bejn it- 18- 60 sena rċievew Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg fejn segwew skeda ta ’ 0, 21 ġurnata.
Twenty-one days after the first and second dose of the vaccine, the seroprotection rate, the seroconversion rate and seroconversion factor for anti-haemagglutinin (anti-HA) antibody were as follows:
Wieħed u għoxrin ġurnata wara l- ewwel u t- tieni doża tal- vaċċin, ir- rata ta ’ seroprotezzjoni, ir- rata ta ’ serokonverżjoni, u l- fattur ta ’ serokonverżjoni, għall- antikorp kontra l- emagglutinina (anti- HA) kienu kif ġej:
anti-HA antibody Seroprotection rate*† Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
Antikorp anti- HA Rata ta ’ seroprotezzjoni * † Rata ta ’ serokonverżjoni † Fattur ta ’ serokonverżjoni † * anti- HA ≥1: 40
21 days after 1st dose 44.5% 42.5% 4.1
21 ġurnata wara l- ewwel doża 44. 5% 42. 5% 4. 1
21 days after 2nd dose 94.3% 93.7% 39.8
21 ġurnata wara t- tieni doża 94. 3% 93. 7% 39. 8
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
† rata ta ’ seroprotezzjoni: proporzjon ta ’ individwi b’ titre ta ’ inibizzjoni ta ’ l- emagglutinizazzjoni (HI) ≥ 1: 40; rata ta ’ serokonverżjoni: proporzjon ta ’ individwi li jew kienu seronegattivi qabel it- tilqim u għandhom titre protettiv ta ’ ≥ 1: 40 wara t- tilqim, jew kienu seropożittivi qabel it- tilqim u għandhom żieda ta ’ 4 darbiet aktar fit- titre; fattur ta ’ serokonverżjoni: proporzjon tal- medja tat- titre ġeometriku (GMT) wara t- tilqim u GMT qabel it- tilqim.
Twenty-one days after administration of the second dose, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres.
5 Wieħed u għoxrin ġurnata wara l- amministrazzjoni tat- tieni doża, 96. 0% ta ’ l- individwi kellhom żieda fit- titres ta ’ antikorp li jinnewtralizza s- serum ta ’ 4 darbiet aktar.
A neutralising antibody titre of at least 1:80 was achieved in 97.8% of subjects at day 42.
Ġie milħuq titre ta ’ antikorp li jinnewtralizza ta ’ mill- anqas 1: 80 f’ 97. 8% ta ’ l- individwi f’ jum 42.
5 In a dose finding study in subjects aged 18-60 years, 50 subjects received a dose of 3.75 micrograms HA/ AS03 in a volume of 1 ml at 0 and 21 days.
Fi studju biex tinstab id- doża, f’ individwi ta ’ età bejn it- 18- 60 sena, 50 individwu rċieva doża ta ’ 3. 75 mikrogrammi HA/ AS03 f’ volum ta ’ 1 ml fil- ġranet 0 u 21.
The seroprotection rates, seroconversion rates and seroconversion factors for anti-haemagglutinin (anti-HA) antibody at day 42 (post dose 2) and day 180 (persistence) were as follows:
Ir- rati ta ’ seroprotezzjoni, rati ta ’ serokonverżjoni u l- fatturi ta ’ serokonverżjoni għall- antikorp kontra l- emagglutinina (anti- HA) f’ jum 42 (wara t- tieni doża) u f’ jum 180 (persistenza) kienu kif ġej:
Day 42 84% 82% 27.9
Jum 42 84% 82% 27. 9
Day 180 54% 52% 4.4
Jum 180 54% 52% 4. 4
A 4-fold increase in serum neutralising antibody titres was observed in 85.7% of subjects at day 42 and 72% at day 180.
Żieda ta ’ 4 darbiet aktar fit- titres ta ’ l- antikorp li jinnewtralizza s- serum kienet osservata f’ 85. 7% ta ’ l - individwi fil- ġurnata 42 u fi 72% fil- ġurnata 180.
Cross-reactive immune response against variants of A/ Vietnam/ 1194/ 2004 (H5N1):
Respons immuni cross- reactive kontra varjanti ta ’ A/ Vietnam/ 1194/ 2004 (H5N1):
In the consistency study the seroprotection rate, seroconversion rate and seroconversion factor for anti- haemagglutinin (anti-HA) antibody against A/ Indonesia/ 5/ 2005 at 21 days after the second dose were as follows:
Fl- istudju ta ’ konsistenza, r- rata ta ’ seroprotezzjoni, ir- rata ta ’ serkonverżjoni u l- fattur ta ’ serokonverżjoni għall- antikorp kontra l- emagglutinina (anti- HA) kontra A/ Indonesia/ 5/ 2005 f’ 21 ġurnata wara t- tieni doża, kienu kif ġej:
Seroprotection rate*† Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
Rata ta ’ seroprotezzjoni * † Rata ta ’ serokonverżjoni † Fattur ta ’ serokonverżjoni † * anti- HA ≥1: 40
50.2% 50.2% 4.9
50. 2% 50. 2% 4. 9
seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
† rata ta ’ seroprotezzjoni: proporzjon ta ’ individwi b’ titre ta ’ inibizzjoni ta ’ l- emagglutinizazzjoni (HI) ≥ 1: 40; rata ta ’ serokonverżjoni: proporzjon ta ’ individwi li jew kienu seronegattivi qabel it- tilqim u għandhom titre protettiv ta ’ ≥ 1: 40 wara t- tilqim, jew kienu seropożittivi qabel it- tilqim u għandhom żieda ta ’ 4 darbiet aktar fit- titre; fattur ta ’ serokonverżjoni: proporzjon tal- medja tat- titre ġeometriku GMT wara t- tilqim u GMT qabel it- tilqim.
A 4-fold increase in serum neutralising antibody titres was obtained in 91.4% of subjects at day 42.
Żieda ta ’ 4 darbiet aktar fit- titres ta ’ l- antikorpi li jinnewtralizzaw is- serum inkisbu f’ 91. 4% ta ’ l - individwi fil- ġurnata 42.
In the dose finding studythe seroprotection rate, seroconversion rate and seroconversion factor against H5N1 drift variants 21 days after the second dose were as follows:
Fl- istudju biex tinstab id- doża, r- rata ta ’ seroprotezzjoni, ir- rata ta ’ serokonverżjoni, u l- fattur ta ’ serokonverżjoni kontra varjanti mibdula ta ’ H5N1, 21 ġurnata wara t- tieni doża kienu kif ġej:
20.0% 20.0% 2.0
20. 0% 20. 0% 2. 0
35.0% 35.0% 3.4
35. 0% 35. 0% 3. 4
60.0% 60.0% 4.7
60. 0% 60. 0% 4. 7
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
† rata ta ’ seroprotezzjoni: proporzjon ta ’ individwi b’ titre ta ’ inibizzjoni ta ’ l- emagglutinizazzjoni (HI) ≥ 1: 40; rata ta ’ serokonverżjoni: proporzjon ta ’ individwi li jew kienu seronegattivi qabel it- tilqim u
6 Twenty one days after the second dose, a 4-fold increase in serum neutralising antibody titres was obtained in 77.1% of subjects against the A/ Indonesia/ 5/ 2005 strain, in 75.0% of subjects against A/ Anhui/ 01/ 2005 and in 85.0% of subjects against A/ Turkey/ Turkey/ 1/ 2005.
Wieħed u għoxrin ġurnata wara t- tieni doża, żieda ta ’ 4 darbiet aktar fit- titres ta ’ l- antikorp li jinnewtralizza s- serum inkiseb f’ 77. 1% ta ’ l- individwi kontra r- razza A/ Indonesia/ 5/ 2005, f’ 75. 0% ta ’ l- individwi kontra A/ Anhui/ 01/ 2005 u f’ 85. 0% ta ’ l- individwi kontra A/ Turkey/ Turkey/ 1/ 2005.
Information from non-clinical studies:
Informazzjoni minn studji mhux kliniċi:
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically using ferret challenge models.
Il- ħila li jinduċi protezzjoni kontra razez omologi u eteroloġi tal- vaċċin kienet studjata b’ mod mhux kliniku fejn intuża l- mudell ta ’ eżami fuq nemes biex wieħed jara jekk il- kura għall- immunità irnexxietx.
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG-14).
F’ kull esperiment erba ’ gruppi ta ’ 6 inmsa kienu mlaqqma fil- muskolu b’ vaċċin supplimentat b’ AS03 li kien fih HA li tnisslet minn H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG- 14).
Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
Dożi ta ’ 15, 5, 1. 7 jew 0. 6 mikrogrammi ta ’ HA ġew ittesjati fl- esperiment ta ’ sfida omologu, u dożi ta ’ 15, 7. 5, 3. 8 jew 1. 75 mikrogrammi ta ’ HA ġew ittesjati fl- esperiment ta ’ sfida eterologu.
Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Il- gruppi ta ’ kontroll kienu jinkludu inmsa mlaqqma bis- suppliment biss, bil- vaċċin mhux supplimentat (15- il mikrogramma HA) jew b’ soluzzjoni ta ’ salina ibbafferjata bil- fosfat.
Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/ A/ Vietnam/ 1194/ 04 or heterologous H5N1/ A/ Indonesia/ 5/ 05.
L- inmsa kienu mlaqqma fil- ġranet 0 u 21 u ngħataw doża ta ’ sfida ġot- trakea fil- ġurnata 49 b’ doża letali ta ’ H5N1/ A/ Vietnam/ 1194/ 04 jew H5N1/ A/ Indonesia/ 5/ 05 eterologu.
Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively.
Mill- annimali li ħadu l- vaċċin supplimentat, 87% u 96% kienu protetti kontra l- eżami omologu jew eterologu rispettivament, li seta ’ jikkaġuna l- mewt.
Viral shedding into the upper respiratory tract was also reduced in vaccinated animals relative to controls, suggesting a reduced risk of viral transmission.
It- tixrid virali għal ġo n- naħa ta ’ fuq ta ’ l- apparat tan- nifs kien ukoll imnaqqas fl- annimali mlaqqma meta mqabbel mal- kontrolli, li jissuġġerixxi riskju mnaqqas ta ’ trasmissjoni virali.
In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge.
Fil- grupp ta ’ kontroll mhux supplimentat, kif ukoll fil- grupp ta ’ kontroll supplimentat, l- annimali kollha mietu jew kellhom jinqatlu mingħajr uġigħ minħabba li kienu moribondi, bejn tlieta u erbgħat ijiem wara li nbeda l - eżami.
Not applicable.
Ma japplikax.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Informazzjoni li mhix klinka, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku akut u minn dożi ripetuti, tolleranza lokali, effett tossiku fuq il- fertilità tal- mara, fuq l- embriju - fetu u wara t- twelid (sa tmiem il- perijodu ta ’ treddiegħ) ma turi l- ebda periklu speċjali għall- bnedmin.
Suspension vial:
Kunjett ta ’ suspensjoni:
Polysorbate 80 Octoxynol 10 Thiomersal Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections
Polysorbate 80 Octoxynol 10 Thiomersal Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Ilma għall- injezzjonijiet
Emulsion vial:
Kunjett ta ’ l- emulsjoni:
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
7 Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Ilma għall- injezzjonijiet
After mixing, the vaccine should be used within 24 hours.
Wara li jitħallat il- vaċċin irid jintuża fi żmien 24 siegħa.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Waqt l- użu, l- istabbilità kimika u fisika ġiet ipprovata għal perjodu ta ’ 24 siegħa f’ temperatura ta ’ 25°C.
Store in the original package in order to protect from light.
Żommu fil- pakkett oriġinali biex tilqagħlu mid- dawl.
One pack containing:
Pakkett wieħed fih:
- one pack of 50 vials (type I glass) of 2.5 ml suspension (10 x 0.25 ml doses) with a stopper
- pakkett wieħed ta ’ 50 kunjett (ħġieġ tat- tip I) ta ’ 2. 5 ml suspenjoni (10 dożi x 0. 25 ml) b’ tapp
(butyl rubber).
(gomma butyl).
- two packs of 25 vials (type I glass) of 2.5 ml emulsion (10 x 0.25 ml doses) with a stopper
- żewġ pakketti ta ’ 25 kunjett (ħġieġ tat- tip I) ta ’ 2. 5 ml emulsjoni (10 dożi x 0. 25 ml) b’ tapp
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
Il- volum wara li jiħallat kunjett wieħed ta ’ suspensjoni (2. 5 ml) ma ’ kunjett wieħed ta ’ emulsjoni (2. 5ml) jikkorispondi għal 10 dożi ta ’ vaċċin (5ml).
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two containers:
Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg jikkonsisti f’ żewġ kontenituri:
Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Kunjett A: kunjett b’ ħafna dożi li fih l- antiġen (suspensjoni), Kunjett B: kunjett b’ ħafna dożi li fih is- suppliment (emulsjoni).
Prior to administration, the two components should be mixed.
Qabel jingħata, iż- żewġ komponenti għandhom jitħalltu.
Instructions for mixing and administration of the vaccine:
Struzzjonijiet dwar it- taħlit u l- għoti tal- vaċċin:
Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/ or abnormal physical appearance.
Qabel ma tħallat iż- żewġ komponenti, l- emulsjoni u s- suspensjoni għandhom jitħallew jilħqu t - temperatura tal- kamra, jitħawwdu, u jiġu spezzjonati viżwalment għal xi frak u/ jew dehra fiżika mhux normali.
In the event of either being observed, discard the vaccine.
F’ każ li kwalunkwe waħda minnhom tiġi osservata, armi l- vaċċin.
The vaccine is mixed by withdrawing the contents of the vial containing the emulsion (Vial B) by means of a syringe and by adding it to the vial containing the suspension (Vial A).
Il- vaċċin jitħallat billi tiġbed il- kontenut tal- kunjett li fih l- emulsjoni (Kunjett B) permezz ta ’ siringa u żżidu mal- kunjett li fih is- suspensjoni (Kunjett A).
After the addition of the emulsion to the suspension, the mixture should be well shaken.
Wara ż- żieda ta ’ l- emulsjoni mas- suspensjoni, it- taħlita għandha titħawwad sewwa.
The mixed vaccine is a whitish emulsion.
Il- vaċċin imħallat huwa emulsjoni bajdanija.
In the event of other variation being observed, discard the vaccine.
F’ każ li tiġi osservata xi varjazzjoni oħra, armi l- vaċċin.
The volume of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (5 ml) after mixing corresponds to 10 doses of vaccine.
Il- volum ta ’ Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals 3. 75 µg (5 ml) wara li jitħallat jikkorisspondi għal 10 dożi ta ’ vaċċin.
The vial should be shaken prior to each administration.
Il- kunjett għandu jitħawwad qabel kull darba li tingħata doża.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Kull doża ta ’ vaċċin ta ’ 0. 5 ml tinġibed ġo siringa għall- injezzjoni.
The needle used for withdrawal must be replaced by a needle suitable for intramuscular injection.
Il- labra użata biex tiġbed id- doża għanda tinbidel b’ labra adattata għal injezzjoni għal ġol - muskolu.
GlaxoSmithKline Biologicals s. a. rue de l'Institut 89 B-1330 Rixensart, Belgium
GlaxoSmithKline Biologicals s. a. rue de l' Institut 89 B- 1330 Rixensart, Il- Belġju
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 GĦALL- HRUĠ TAL - LOTT B.
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 GĦALL- HRUĠ TAL- LOTT
KG Zirkustraße 40, D-01069 Dresden Germany
KG Zirkustraße 40, D- 01069 Dresden Il- Ġermanja
89, rue de l'Institut B-1330 Rixensart Belgium
89, rue de l' Institut B- 1330 Rixensart Il- Belġju
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version V03 (dated 19 November 2007) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni V03 (bid- data ta ’ 19 ta ’ Novembru 2007) ppreżentata fit- Taqsima 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat - Tqegħid fis- Suq, qiegħda f’ postha u tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.