qanastek/EMEA-V3 huggingface dataset:
Adverse event(s) from post-marketing surveillance with the pandemic vaccine: not applicable.
Episodji avversi minn sorveljanza ta 'wara l- kummerċjalizzazzjoni bil- vaċċin pandemiku: mhux applikabbli.
Influenza vaccine, ATC Code:
Vaċċin tal- Influwenza; Kodiċi ATC:
This section describes the clinical experience with the mock-up vaccines following a two-dose administration.
Din is- sezzjoni tiddeskrivi l- esperjenza klinika bil- vaċċini mock- up wara l- għoti ta 'żewġ dożi.
Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Il- vaċċini mock- up fihom antiġeni ta 'l- influwenza li huma differenti minn dawk li hemm fil- virusijiet ta' l- influwenza li hawn bħalissa.
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the 4 target population for vaccination is immunologically naïve.
Dawn l- antiġeni jistgħu jitqiesu bħala antiġeni 'ġodda' u jistimulaw sitwazzjoni fejn il- popolazzjoni immirata għat- tilqim tkun immunoloġikament naive.
Data obtained with a mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical efficacy and safety data obtained with mock-up vaccines are relevant for the pandemic vaccines.
It- tagħrif miksub b' vaċċin mock- up għandu jsostni strateġija ta 'tilqim li aktarx tintuża għall- vaċċin pandemiku: it- tagħrif dwar l- effikaċja u s- sigurta' fl- użu kliniku miksuba bil- vaċċini mock- up huwa rilevanti għall- vaċċini pandemiċi.
A clinical trial was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 486 healthy adult volunteers.
Saret prova klinika b’ vaċċin ta ’ H5N1 ikkombinat ma ’ adjuvant ta ’ MF59C. 1 f’ 486 adulti voluntiera b’ saħħithom.
Two doses of vaccine containing H5N1 (A/ Vietnam/ 1194/ 2004) at 2 different dosages (7.5 and 15 µg hemagglutinin [HA]/ dose) with MF59C.1 adjuvant were administered three weeks apart.
Żewġ dożi ta ’ vaċċin li fihom H5N1 (A/ Vietnam/ 1194/ 2004) f’ 2 dożaġġi differenti (7. 5 u 15 µg hemagglutinin [HA] / doża) b’ adjuvant ta ’ M559C. 1 kienu amministrati tliet ġimgħat minn xulxin.
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody in the adults measured by SRH were as follows:
Ir- rata ta ’ seroprotezzjoni *, ir- rata ta ’ serokonverżjoni * u l- fattur tas- serokonverżjoni ** għall - antikorp anti- HA fl- adulti mkejjla minn SRH kienu kif ġejjin:
anti-HA antibody
antikorp anti- HA
22 days after 1st dose
22 jum wara l- ewwel doża
21 days after 2nd dose
21 jum wara t- tieni doża
Seroprotection rate Seroconversion rate Seroconversion factor * measured by SRH assay ≥ 25 mm ** geometric mean ratios of SRH
Rata ta ’ seroprotezzjoni Rata ta ’ serokonverżjoni Fattur ta ’ serokonverżjoni ** * mkejjel b’ assay SRH ≥ 25 mm
31-47) 2.42 (2.02-2.89)
31- 47) 2. 42 (2. 02- 2. 89)
79-91) 7.85 (6.7-9.2)
79- 91) 7. 85 (6. 7- 9. 2)
The seroprotection rate*, seroconversion rate* and the seroconversion factor ** for anti-HA antibody in subjects aged over 60 measured by SRH were as follows:
Ir- rata ta ’ seroprotezzjoni *, ir- rata ta ’ serokonverżjoni u l- fattur tas- serokonverżjoni ** għall- antikorp anti- HA f’ suġġetti li għandhom aktar minn 60 sena mkejjla minn SRH kienet kif ġejja:
anti-HA antibody
Antikorp anti- HA
22 days after 1st dose
22 jum wara l - ewwel doża
21 days after 2nd dose
21 jum wara t - tieni doża
Seroprotection rate Seroconversion rate Seroconversion factor * measured by SRH assay ≥ 25 mm ** geometric mean ratios of SRH
Rata ta ’ seroprotezzjoni Rata ta ’ serokonverżjoni Fattur ta ’ serokonverżjoni ** * mkejjel b’ assaġġ SRH ≥ 25 mm
34-56) 2.85 (2.22-3.66)
34- 56) 2. 85 (2. 22- 3. 66)
60-81) 5.02 (3.91-6.45)
60- 81) 5. 02 (3. 91- 6. 45)
The persistence of antibodies for the mock-up vaccines varies.
** proporzjonijiet medji ġeometriċi ta ’ SRH
With the interpandemic trivalent vaccines it is usually 6-12 months, but for this vaccine no data are available yet with the H5N1 strain.
Il- persistenza ta ’ antikorpi għal vaċċini mock- up tvarja. Bil- vaċċini intrapandemiċi trivalenti din ġeneralment tkun għal 6- 12- il xahar, imma għal dan il- vaċċin għad mhemmx informazzjoni disponibbli bir- razza ta ’ H5N1.
• Supportive Studies
• Studji ta ’ Sostenn
In two dose finding studies 78 adults received an adjuvanted mock-up vaccine (H5N3 or H9N2).
F’ żewġ studji għat- tfittxija tad- doża, 78 adult irċivew vaċċin mock- up adjuvanti (H5N3 jew H9N2).
Two doses of vaccine with H5N3 (A/ Duck/ Singapore/ 97) strain at 3 different dosages (7.5, 15 and 30 µg HA/ dose) were administered three weeks apart.
Żewġ dożi tal- vaċċin bir- razza tal- H5N3 (A/ Duck/ Singapore/ 97) fi tliet dożaġġi differenti (7. 5, 15 u 30 µg HA/ doża) kienu mogħtija tliet ġimgħat il- bogħod minn xulxin.
Serum samples were tested against the original H5N3 and also a number of H5N1 isolates.
Kampjuni tas- serum kienu ttestjati kontra l- H5N3 oriġinali kif ukoll ma numru ta 'iżolati ta' l- H5N1.
Serologic responses obtained with the SRH assay showed that 100% of subjects achieved seroprotection and 100% seroconverted after two 7.5 μ g injections.
Risponsi seroloġiċi miksuba minn assay SRH wrew li 100% tas- suġġetti kisbu seroprotezzjoni u 100% ġew serokonvertiti wara żewġ injezzjonijiet ta ’ 7. 5 μg.
The adjuvanted vaccine was also found to induce antibodies that cross-protected against the H5N1 strains isolated in 2003 and 2004, which exhibit some antigenic drift compared to the original strains.
Il- vaċċin bl- adjuvant instab li stimola antikorpi li taw protezzjoni ukoll kontra għamliet ta 'H5N1 iżolati fl- 2003 u l- 2004 li jippreżentaw xi ċaqliqa antiġenika meta mqabbla mal- għamliet oriġinali.
Two doses of vaccine containing H9N2 (A/ chicken/ Hong Kong/ G9/ 97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/ dose), were administered four weeks apart.
5 Żewġ dożi tal- vaċċin bl- għamla ta 'H9N2 (A/ chicken/ Hong Kong/ G9/ 97) f' erba' dożaġġi differenti (3. 75, 7. 5, 15 u 30 μg HA/ doża) kienu mogħtija erba 'ġimgħat' il bogħod minn xulxin.
Serologic responses obtained with the Hemagglutination Inhibition (HI) assay showed that 92% of subjects achieved seroprotection and 75% seroconverted after two 7.5 μ g injections.
Risponsi seroloġiċi miksuba bl- assay ta ’ Hemagglutination Inhibition (HI) wera li 92% tas- suġġetti kisbu seroprotezzjoni u 75% ġew serokonvertiti wara żewġ injezzjonijiet ta ’ 7. 5 μg.
Focetria has been authorised under “ Exceptional Circumstances”.
Focetria kien awtorizzat taħt “ Ċirkustanzi ta ’ Eċċezzjoni ”.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Dan ifisser li għal raġunijiet xjentifiċi ma kienx possibbli li tinkiseb informazzjoni kompleta dwar il - benefiċċji u r- riskji ta ’ dan il- prodott mediċinali.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
L- Aġenzija Ewropea dwar il- mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ kull sena u ser taġġorna dan is- Sommarju tal- Karatteristiċi tal- Prodott, skond il- bżonn.
5 Not applicable.
Ma jgħoddx f' dan il- każ.
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate, Citric acid, Water for injections.
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate Citric acid Ilma għall- injezzjonijiet.
For the adjuvant, see section 2.
Għas- sustanza adjuvanti, ara sezzjoni 2.
1 year.
Sena.
0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
0. 5 ml f' siringa mimlija għal- lest (ħġieġ ta 'tip I) bi planġer- stopper (lastku bromo- butyl).
Packs of 1 and 10.
Pakketti ta '1 u 10.
Not all pack sizes may be marketed.
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
6.6 Special precautions for disposal and other handling
6 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
The vaccine should be allowed to reach room temperature before use.
Il- vaċċin għandu jitħalla jilħaq it- temperatura tal- kamra qabel jintuża.
Gently shake before use.
Ħawwad bil- mod qabel tuża.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Kull vaċċin li ma jiġix użat jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l - liġijiet lokali
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italy.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, L- Italja.
Focetria suspension for injection Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
Vaċċin kontra l- influwenza pandemika (antiġeni tal- wiċċ, inattivati, adjuvantat)
For further information, see section 5.1.
8 Għal aktar tagħrif ara sezzjoni 5. 1
8 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
From the clinical trials with the pandemic vaccine, most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
9 Mit- testijiet kliniċi bil- vaċċin pandemiku, il- biċċa l- kbira tar- reazzjonijiet kienu ta 'natura ħafifa, damu żmien qasir u kienu kwalitattivament simili għal dawk ikkawżati minn vaċċini konvenzjonali kontra l - influwenza staġjonali.
9 Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).
Reazzjonijiet avversi minn testijiet kliniċi bil- vaċċin mock- up huma elenkati hawn isfel (ara sezzjoni 5. 1 għal aktar informazzjoni dwar il- vaċċini mock- up).
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the 10 target population for vaccination is immunologically naïve.
Dawn l- antiġeni jistgħu jitqiesu bħala antiġeni 'ġodda' u jistimulaw sitwazzjoni fejn il- popolazzjoni immirata għat- tilqim tkun immunoloġikament naive.
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody in subjects aged over 60 measured by SRH were as follows:
Ir- rata ta ’ seroprotezzjoni *, ir- rata ta ’ serokonverżjoni u l- fattur tas- serokonverżjoni ** għall- antikorp anti- HA f’ suġġetti li għandhom aktar minn 60 sena mkejjla minn SRH kienet kif ġejja:
Two doses of vaccine containing H9N2 (A/ chicken/ Hong Kong/ G9/ 97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/ dose), were administered four weeks apart.
11 Żewġ dożi tal- vaċċin bl- għamla ta 'H9N2 (A/ chicken/ Hong Kong/ G9/ 97) f' erba' dożaġġi differenti (3. 75, 7. 5, 15 u 30 μg HA/ doża) kienu mogħtija erba 'ġimgħat' il bogħod minn xulxin.
11 Not applicable.
Ma jgħoddx f' dan il- każ.
0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber).
0. 5 ml f' kunjett ta 'doża waħda (ħġieġ ta' tip I) bi stopper (lastku halo- butyl).
Packs of 10.
Pakketti ta '10.
The vaccine should be allowed to reach room temperature before use.
12 Il- vaċċin għandu jitħalla jilħaq it- temperatura tal- kamra qabel jintuża.
Focetria suspension for injection in multidose container Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
Vaċċin kontra l- influwenza pandemika (antiġeni tal- wiċċ, inattivati, adjuvantat)
7.5 micrograms ** per 0.5 ml dose
7. 5 mikrogrammi ** għal kull doża ta '0. 5 ml
polysorbate 80 sorbitan trioleate Excipients:
polysorbate 80 sorbitan trioleate
0.05 milligrams
0. 05 milligrammi
This is a multidose container.
Dan huwa kontenitur b' ħafna dożi.
See section 6.5 for the number of doses per vial.
Ara sezzjoni 6. 5 għan- numru ta 'dożi f' kull kunjett.
This vaccine complies with the WHO recommendations and EU decision for the pandemic.
Dan il- vaċċin jikkonforma mar- rakkomandazzjonijiet tal- WHO u mad- deċiżjoni ta 'l- UE għall - pandemija.
4.2 Posology and method of administration
Pożoloġija u metodu ta 'kif għandu jingħata 4. 2
Therefore health care providers need to assess the benefits and potential risks of administering the vaccine in that population.
14 Għalhekk persuni li jipprovdu l- kura tas- saħħa għandhom bżonn iqisu is- siwi u r- riskji potenzjali għall- amministrazzjoni tal- vaċċin f’ din il- popolazzjoni
14 For pregnant women, see section 4.6.
Għal nisa tqal ara sezzjoni 4. 6.
For further information, see section 5.1.
Għal aktar tagħrif ara sezzjoni 5. 1
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 eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Hija meħtieġa attenzjoni meta dan il- vaċċin jingħata lil persuni b' sensittività eċċessiva magħrufa (apparti r- reazzjoni anafilattika) għas- sustanza attiva, għal xi sustanza mhux attiva, għal thiomersal u għall- bajd, proteini tat- tiġieġ, kanamycin u neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide (CTAB).
• Clinical trials In clinical trials with different formulations (H5N3, H9N2 and H5N1) 542 subjects were exposed to thecandidate vaccine.
Fi provi kliniċi b’ fomulazzjonijiet differenti (H5N3, H9N2 u H5N1) 542 suġġetti kienu esposti għall— vaċċin li kien qed jiġi studjat.
It is widely
Mit- testijiet kliniċi bil- vaċċin pandemiku, il- biċċa l- kbira tar- reazzjonijiet kienu ta 'natura ħafifa, damu żmien qasir u kienu kwalitattivament simili għal dawk ikkawżati minn vaċċini konvenzjonali kontra l - influwenza staġjonali.
15 accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Huwa ġeneralment aċċettat li l- effett adjuvanti li jwassal għal immunoġeniċità akbar huwa assoċjat ma 'frekwenza kemm xejn akbar ta' reazzjonijiet lokali (fil- biċċa l- kbira uġigħ ħafif) meta mqabbel ma 'vaċċini konvenzjonali, mhux adjuvanti kontra l- influwenza.
Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).
Reazzjonijiet avversi minn testijiet kliniċi bil- vaċċin mock- up huma elenkati hawn isfel (ara sezzjoni 5. 1 għal aktar informazzjoni dwar il- vaċċini mock- up).
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).
16 Dan il- prodott mediċinali fiħ it- thiomersal (kompost organomerkuriku) bħala preservattiv u għalhekk, huwa possibbli li jkun hemm reazzjonijiet ta 'sensibilizzazzjoni (ara sezzjoni 4. 4).
5.1 Pharmacodynamic properties 16 Pharmacotherapeutic group:
5. 1 Tagħrif farmakodinamiku
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 'ġodda' u jistimulaw sitwazzjoni fejn il- popolazzjoni immirata għat- tilqim tkun immunoloġikament naive.
The seroprotection rate* seroconversion rate* and the seroconversion factor ** for anti-HA antibody in the adults measured by SRH were as follows:
Ir- rata ta ’ seroprotezzjoni *, ir- rata ta ’ serokonverżjoni * u l- fattur tas- serokonverżjoni ** għall - antikorp anti- HA fl- adulti mkejjla minn SRH kienu kif ġejjin:
The seroprotection rate* seroconversion rate* and the seroconversion factor ** for anti-HA antibody in subjects aged over 60 measured by SRH were as follows:
Ir- rata ta ’ seroprotezzjoni *, ir- rata ta ’ serokonverżjoni u l- fattur tas- serokonverżjoni ** għall- antikorp anti- HA f’ suġġetti li għandhom aktar minn 60 sena mkejjla minn SRH kienet kif ġejja:
In two dose finding studies 78 adults received an adjuvanted mock-up vaccine (H5N3 or H9N2).
17 F’ żewġ studji għat- tfittxija tad- doża, 78 adult irċivew vaċċin mock- up adjuvanti (H5N3 jew H9N2).
Two doses of vaccine containing H9N2 (A/ chicken/ Hong Kong/ G9/ 97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/ dose), were administered four weeks apart.
Żewġ dożi tal- vaċċin bl- għamla ta 'H9N2 (A/ chicken/ Hong Kong/ G9/ 97) f' erba' dożaġġi differenti (3. 75, 7. 5, 15 u 30 μg HA/ doża) kienu mogħtija erba 'ġimgħat' il bogħod minn xulxin.
17 Focetria has been authorised under “ Exceptional Circumstances”.
Focetria kien awtorizzat taħt “ Ċirkustanzi ta ’ Eċċezzjoni ”.
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate, Citric acid, Thiomersal, Water for injections.
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate Citric acid Thiomersal Ilma għall- injezzjonijiet.
Store in a refrigerator (2°C - 8°C).
18 Aħżen fi friġġ (2°C - 8°C).
5.0 ml in 10-dose vial (type I glass) with stopper (halo-butyl rubber).
5. 0 ml f' kunjett ta '10 dożi (ħġieġ ta' tip I) bi stopper (lastku halo- butyl).
MARKETING AUTHORISATION HOLDER 18 Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italy.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, L- Italja.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI TAD- DETENTUR TA 'AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
(Manufacturer responsible for monovalent pooled harvests, before final filtration):
(Manifattur responsabbli għal monovalent pooled harvests, qabel il- filtrazzjoni finali):
Via Fiorentina, 1 – 53100 Siena Italy
Via Fiorentina, 1 – 53100 Siena Italja
(Manufacturer responsible for final filtration of monovalent pooled harvest):
(Manifattur responsabbli għall- filtrazzjoni finali ta ’ monovalent pooled harvest):
Bellaria – 53018 Rosia – Sociville (SI) Italy
Bellaria – 53018 Rosia – Sociville (SI) Italja
Focetria can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Focetria takes due account of the officially declared pandemic strain.
Focetria jista ’ jitpoġġa fis- suq biss meta jkun hemm dikjarazzjoni uffiċjali tal- WHO/ UE ta ’ influwenza pandemika, bil- kundizzjoni li d- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għal Focetria jikkunsidra r- razza pandemika li tkun uffiċjalment iddikjarata.
Not applicable
Ma jgħoddx f' dan il- każ.
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC kif emendata, il- ħruġ tal- lott uffiċjali isir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
Pharmacovigilance system
Sistema ta ’ Farmakoviġilanza
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jrid jiżgura li s- sistema ta ’ farmakoviġilanza tkun implimentata u tkun taħdem qabel ma l- prodott jibda jinbiegħ, u sakemm il- prodott li jkun inbiegħ jibqa ’ jintuża.
PSUR submission during the influenza pandemic:
Sottomissjoni tal- PSUR (Rapporti Perjodiċi dwar l- Aġġornament tas- Sigurtà) matul l- influwenza pandemika:
During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/ 2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Matul sitwazzjoni pandemika, il- frekwenza tas- sottomissjoni tar- rapporti perjodiċi dwar l - aġġornament tas- sigurtà speċifikati f’ Artikolu 24 tar- Regolazzjoni (KE) Nru.
Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
726/ 2004 mhux 21 ser tkun adegwata għall- monitoraġġ tas- sigurtà ta ’ tilqima kontra l- pandemija, li għaliha, livelli għolja ta ’ espożizzjoni huma mistennija f’ perjodu ta ’ żmien qasir.
Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be
Analiżi fil- pront ta ’ l - informazzjoni kumulattiva tas- sigurtà, fid- dawl tal- medda ta ’ l- espożizzjoni, ser tkun kruċjali għad- deċiżjonijiet regulatorji u l- protezzjoni tal- popolazzjoni li ser titlaqqam.
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Flimkien ma ’ dan, it- tul ta ’ żmien tal- pandemija, ir- riżorsi meħtieġa għal evalwazzjoni fil- fond tar- Rapporti Perjodiċi dwar l- Aġġornament tas- Sigurtà fil- format kif definit f’ Volum 9a tar- Regoli li Jirregolaw il- Prodott Mediċinali tista ’ ma tkunx adegwata għal identifikazzjoni mgħaġġla ta ’ tema ġdida tas- sigurtà.
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
Bħala konsegwenza, hekk kif il- pandemija tkun iddikjarata (Fażi 6 tal- pjan globali tal- WHO dwar il- preparazzjoni għall- Influwenza) u t- tilqim tal- pandemija jintuża, id- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jissottometti rapporti perjodiċi dwar l - aġġornament tas- sigurtà bil- perjodiċità u l- format definiti kif ġej:
Frequency of submission
Frekwenza tas- sottomissjoni
- The clock will start from the first Monday after shipment of the first batch of vaccine.
- Il- ħin jibda għaddej mill- ewwel nhar ta ’ Tnejn wara li jintbagħat l- ewwel lott tat- tilqima.
- First data-lock point is 14 days later.
- L- ewwel data- lock point hu 14- il jum wara.
- Report submission is no later than day 22 (i. e. the following Monday).
- Is- sottomissjoni tar- rapport tkun mhux iktar tard minn Jum 22 (i. e.
- Reporting to be fortnightly for the first 3 months of the pandemic.
- Ir- rappurtaġġ ikun kull ħmistax għall- ewwel 3 xhur tal- pandemija.
- Periodicity will be reviewed by the MAH and the (Co-)Rapporteur at 3 monthly intervals.
(Ko -) Rapporteur f’ intervalli ta ’ 3 xhur.
Format The report shall include the following Tables of aggregate data using the agreed templates:
Format Ir- rapporti għandhom jinkludu t- Tabelli ta ’ l- informazzjoni kumulattiva li ġejjin bl- użu tat - templates li kien hemm ftehim dwarhom:
Fatal and/ or life-threatening reactions – for each Preferred Term (PT), including the proportion of fatal reports
Reazzjonijiet fatali u/ jew ta ’ periklu għall- ħajja – għal kull Terminu Preferut (Preferred Term - PT), li jinkludu l- proporzjon ta ’ rapporti fatali
Adverse Events of Special Interest (PTs) Serious unexpected reactions (PTs) All events occurring in the following age groups:
Avvenimenti Avversi ta ’ Interess Speċjali (PTs) Reazzjonijiet serji mhux mistennija (PTs) L- avvenimenti kollha li jseħħu fil- gruppi ta ’ l- età li ġejjin:
6-23 months, 2-8 years, 8-17 years, 18-60 years, > 60 years All events occurring in pregnant women
6- 23 xahar, 2- 8 snin, 8- 17il- sena, 18 - 60 sena, > 60 sena L- avvenimenti kollha li jseħħu f’ nisa tqal
All events reported by patients that have been entered into the database by data-lock point A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.
Deskrizzjoni kumulattiva fil- qosor ta ’ l- avvenimenti kollha rrappurtati matul il- perjodu, imqassma skond it- tip ta ’ min jagħmel ir- rapport (pazjent jew persuna professjonali fil- qasam tal- kura tas- saħħa), serjeta ’, kemm kienu mistennija, u jekk humiex spontanji jew mitluba.
Presentation of data will take into consideration the following recommendations:
Il- preżentazzjoni ta ’ l- informazzjoni ser tikkunsidra r- rakkomandazzjonijiet li ġejjin:
- Serious expected reactions will be reviewed by the MAH as part of their signal detection procedures
- Ir- reazzjonijiet serji mistennija jkunu evalwati mid- Detentur ta ’ l- Awtorizzazzjoni għat -
and will only form part of the report if an issue of concern arises.
Tqegħid fis- Suq bħala parti mill- proċeduri tal- estrazzjoni tas- sinjali u ser jiffurmaw parti mir - rapport biss jekk ikun hemm tema ta ’ tħassib.
- All tables will be based on number of events (presented on PT level, sorted by System Organ Class
- It- tabelli kollha ser ikunu bbażati fuq numru ta ’ avvenimenti (ippreżentati fuq livell ta ’ PT,
[SOC]) and not number of cases.
magħżula skond il- Klassi tas- Sistema ta ’ l- Organi [System Organ Class - SOC]) u mhux fuq in- numru ta ’ każijiet.
- Tables 1 to 4 will be based on events reported from healthcare professionals only.
- Tabelli 1 sa 4 ser ikunu bbażati fuq avvenimenti rrappurtati minn professjonisti fil- qasam tas -
- In Tables 1 to 5, numbers will be provided for events received during the reporting period and
- F’ Tabelli 1 sa 5, numri ser ikunu pprovduti għal avvenimenti li jkunu rċevuti matul il- perjodu
cumulatively.
tar- rappurtaġġ u b’ mod kumulattiv.
Product-specific data can be
- It- tabelli kollha ser ikunu bbażati fuq informazzjoni ġenerika u mhux fuq informazzjoni li tkun
evaluated during signal work-up.
speċifika għall- prodott.
- No line listings are required – these can be provided in signal evaluation reports as necessary.
- L- ebda elenki tal- linja m’ huma meħtieġa – dawn jistgħu jiġu pprovduti fir- rapporti ta ’ l -
A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (in the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
22 Sommarju qasir ser ikun ipprovdut ukoll mar- rapporti perjodiċi dwar l- aġġornament tas- sigurtà, li fih, kwalunkwe problema għandha tiġi enfasizzata, signal work- up prijoritizzat (f’ każ ta ’ avvenimenti multipli) timelines adattati għas- sottomissjoni ta ’ rapport ta ’ l- evalwazzjoni full signal pprovduti.
All signal evaluation reports should be provided, including those that were subsequently not identified as being signals.
Ir- rapporti kollha ta ’ l- evalwazzjoni li jinkludu dawk li kienu sussegwentement mhux identifikati bħala sinjali, għandhom jkunu pprovduti,
A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in:
Sommarju tad- distribuzzjoni tat- tilqima għandu jkun inkluż u għandu jipprovdi dettalji tan- numru ta ’ dożi tat- tiqima mqassmin:
EU member states for the reporting period by batch number, EU member states cumulatively and the rest of the world
fl- Istati Membri ta ’ l- UE għall- perjodu tar- rappurtaġġ skond in- numru tal- lott, fl- Istati Membri ta ’ l- UE b’ mod kumulattiv u fil- bqija tad- dinja.
Risk Management plan
Pjan dwar l- Immaniġġjar tar- Riskju
22 The MAH commits to performing the studies and pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq iwiegħed li jwettaq l- istudji u attivitajiet ta ’ farmakoviġilanza deskritti fil- pjan tal- Farmakoviġilanza.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Pjan dwar l- Immaniġġjar tar- Riskju aġġornat għandu jkun ipprovdut skond il- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskji għal prodotti mediċinali għall- użu uman.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jtemm il- programm ta ’ studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta ’ dawn l- istudji għandhom iservu ta ’ bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena.
During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Matul il- pandemija, l- applikant ser jiġbor informazzjoni dwar is- sigurtà u l- effettività klinika tat- tilqima kontra l - pandemija u jissottometti din l- informazzjoni lil- CHMP għall- evalwazzjoni.
Depending on and after implementation of vaccine when first pandemic will take place.
Jiddependi fuq, u wara l - implimentazzjoni tat- tilqima meta sseħħ l- ewwel pandemija.
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Matul il- pandemija, l- applikant ser iwettaq studju tat- tip cohort prospettiv, kif identifikat fil- pjan tal - Farmakoviġilanza.
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARDBOARD BOX FOR SYRINGE
KAXXA TAL- KARTUN GĦAL SIRINGA
Focetria suspension for injection in pre-filled syringe Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Vaċċin kontra l- Influwenza Pandemika (antiġeni tal- wiċċ, inattivati, adjuvanatati)
One dose (0.5 ml) contains:
Doża waħda (0. 5 ml) fiha:
Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, and adjuvanted with MF59C.1, of strain:
Sustanzi Attivi: antiġeni tal- wiċċ tal- virus ta 'l- influwenza (haemagglutinin u neuraminidase), propagati fil- bajd, u adjuvanti b’ MF59C. 1, tar- razza:
7.5 micrograms haemagglutinin
7. 5 mikrogrammi haemagglutinin
Adjuvant:
Sustanza adjuvanti:
MF59C.1 oil in water emulsion containing squalene, as 80 and sorbitan trioleate in a citrate buffer.
MF59C. 1 emulsjoni ta 'żejt fl- ilma li fiha squalene, bħala l- fażi taż- żejt, stabilizzat bi polysorbate 80 u sorbitan trioleate f' buffer ta' ċitrat.
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, water for injections.
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, ilma għall - injezzjoni.
1 x single dose (0.5 ml) pre-filled syringe 10 x single dose (0.5 ml) pre-filled syringes
1 x siringa mimlija għal- lest ta 'doża waħda (0. 5 ml) 10 x siringi mimlijin għal- lest ta' doża waħda (0. 5 ml)
To be administered intramuscularly into the deltoid muscle.
Għandu jingħata fil- muskolu tad- deltoid.
Warning:
Twissija:
Do not inject intravascularly or subcutaneously.
Tinjettax ġol- vini jew taħt il- ġilda.
EXP.:
JIS
Dispose of in accordance with local regulations.
Armi skond kif jitolbu l- liġijiet lokali.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italy.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italja.
Justification for not including Braille accepted
Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARDBOARD BOX FOR 1-DOSE VIAL
TIKKETTA GĦAL SIRINGA
NAME OF THE MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
Focetria suspension for injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Injezzjoni I. M. fil- muskolu tad- deltoid
STATEMENT OF ACTIVE SUBSTANCE(S)
METODU TA ’ KIF GĦANDU JINGĦATA
One dose (0.5 ml) contains:
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI
Active Ingredients:
Doża waħda (0. 5 ml) fiha:
Vial 10 x 1 dose 1 dose (0.5 ml)
Kunjett 10 x 1 doża 1 doża (0. 5 ml)
Dispose of in accordance with local requirements.
Armi skond kif jitolbu l- liġijiet lokali.
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARDBOARD BOX FOR 10-DOSE VIAL
TIKKETTA GĦAL KUNJETT TA 'DOŻA WAĦDA
Focetria suspension for injection in multidose container Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Injezzjoni I. M. fil- muskolu tad- deltoid
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, thiomersal, water for injections.
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, thiomersal, ilma għall- injezzjoni.
Vial 10 x 10 doses 1 dose (0.5 ml)
Kunjett 10 x 10 dożi 1 doża (0. 5 ml)
Dispose of in accordance with local requirements
Armi skond kif jitolbu l- liġijiet lokali.
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL FOR SYRINGE AND 1-DOSE VIAL
TIKKETTA GĦAL KUNJETT TA '10 DOŻI
Focetria injection Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted) I. M. injection into the deltoid muscle
Injezzjoni I. M. fil- muskolu tad- deltoid
1 dose (0.5 ml)
Kunjett ta '5 ml li fih 10 dożi (0. 5 ml/ doża)
Novartis V & D S. r. l. - Italy Store in a refrigerator.
Novartis V & D S. r. l. – L- Italja Aħżen fi friġġ.
32 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Aqra dan il- fuljett kollu qabel tibda tirċievi din il- mediċina.
LABEL FOR 10-DOSE VIAL
- Żomm dan il- fuljett.
METHOD OF ADMINISTRATION
X' inhu Focetria u għalxiex jintuża 2.
EXPIRY DATE
Qabel ma tirċievi Focetria 3.
BATCH NUMBER
Kif għandek tirċievi Focetria 4.
5 ml vial containing 10 doses (0.5 ml/ dose)
Effetti sekondarji li jista 'jkollu 5.
OTHER
Kif taħżen Focetria 6.
In this leaflet:
Aktar tagħrif
WHAT FOCETRIA IS AND WHAT IT IS USED FOR
X' INHU FOCETRIA U GĦALXIEX JINTUŻA
Focetria is a vaccine against a pandemic influenza (flu).
Focetria huwa vaċċin kontra l- influwenza pandemika (influwenza).
It has to be used for the prophylaxis of influenza in an officially declared pandemic situation.
Jintuża għall- prevenzjoni ta 'l- influwenza f' sitwazzjoni pandemika ddikjarata uffiċjalment.
The vaccine works by causing the body to produce its own protection (antibodies) against the disease
Il- vaċċin jaħdem billi jġiegħel il- ġisem jipproduċi l- protezzjoni tiegħu stess (antikorpi) kontra l- marda.
BEFORE YOU RECEIVE FOCETRIA
QABEL MA TIRĊIEVI FOCETRIA
Do not take Focetria if you:
Tieħux Focetria jekk inti:
- have experienced serious allergic reaction (i. e. life-threatening) to any of the constituents of Focetria,
- ġarrabt reazzjoni allerġika serja (jiġifieri ta 'theddida għal ħajtek) minħabba xi sustanza ta'
- are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Focetria,
- allerġiku/ a (tbati minn sensittività eċċessiva) għal vaċċini ta 'l- influwenza jew sustanzi oħra ta'
- are allergic to eggs, chicken protein,
- allerġiku/ a għall- bajd, proteina tat- tiġieġ,
- are allergic to any antibiotic, formaldehyde, cetyltrimethylammonium bromide (CTAB) and
- allerġiku/ a għal xi antibijotiku, formaldehyde, cetyltrimethylammonium bromide (CTAB) u
polysorbate 80.
polysorbate 80.
Take special care with Focetria if you:
Oqgħod attent ħafna b' Focetria jekk inti:
- feel feverish,
- tħoss li għandek id- deni,
- have any illness or infection,
- marid/ a jew għandek infezzjoni,
- are having immunosuppressive therapy, e. g. corticosteroid treatment or chemotherapy for cancer, or if
- jekk qed tieħu kura immunosuppressiva, eż. kura b’ kortikosteroidi jew kemjoterapija għall -
you have any condition which makes you prone to infections (immunodeficiency conditions), In any of these cases, TELL YOUR DOCTOR, as vaccination may not be recommended, or may need to be delayed.
kanċer, jew jekk għandek xi kundizzjoni li tagħmlek vulnerabbli għall- infezzjonijiet (kundizzjonijiet ta 'immunodefiċjenza), Fi kwalunkwe każ minn dawn, GĦID LIT- TABIB TIEGĦEK, minħabba li t- tilqima tista' ma tkunx rakkomandata, jew jista 'jkun li tkun teħtieġ li tiġi posposta.
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Focetria should not be given at the same time as other vaccines (if another vaccine is required at the same time, then the injection should be carried out on a different limb.
Focetria ma għandux jingħata fl- istes ħin ma 'vaċċini oħra (jekk ikun hemm bżonn ta' vaċċin ieħor fl- istess ħin, l- injezzjoni għandha ssir f' riġel/ driegħ differenti.
In such cases, the side effects may be more intense).
F' każijiet bħal dawn, l- effetti sekondarji jistgħu jkunu aktar intensi.).
Pregnancy and breast-feeding In a severe pandemic situation, the administration of the vaccine is recommended in pregnant women, irrespective of their stage of pregnancy.
Tqala u Treddigħ F' sitwazzjoni pandemika severa, l- amministrazzjoni tal- vaċċin hija rakkomandata f' nisa tqal, irrispettivament mill- fażi tat- tqala tagħhom.
Driving and using machines The vaccine is unlikely to produce any effect on the ability to drive and use machines.
36 Sewqan u tħaddim ta 'magni Il- vaċċin mhux probabbli li jipproduċi xi effett fuq il- ħila biex issuq u tħaddem magni.
HOW TO RECEIVE FOCETRIA
KIF GĦANDEK TIRĊIEVI FOCETRIA
Your doctor or nurse administers the vaccine.
It- tabib jew in- ners tiegħek jagħtik il- vaċċin.
A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle).
Doża (0. 5 ml) tal- vaċċin tiġi injettata fil- parti ta 'fuq tad- driegħ (muskolu tad- deltoid).
Like all medicines, Focetria can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Focetria jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common (in more than 1 out of 100 people, but less than 1 in 10).
(f' aktar minn 1 minn kull 100 persuna, iżda anqas minn 1 f' kull 10).
Common side effects include: redness, swelling, pain at the site of injection, bruising, hardening of the skin injection site.
L- effetti sekondarji komuni jinkludu: ħmura, nefħa, uġigħ fil- post ta 'l- injezzjoni, tbenġil, twebbis tal - ġilda fil- post ta' l- injezzjoni.
In some cases the effects may also include raised temperature, malaise (generally feeling unwell), shivering, tiredness, headache, sweating, pain in muscles and joints.
F' ċerti każijiet l- effetti jistgħu jinkludu wkoll temperatura għolja (deni), telqa tal- ġisem (ġeneralment li ma tħossokx tajjeb), rogħda, għeja, uġigħ ta 'ras, tagħriq, uġigħ fil - muskoli u l- ġogi.
These reactions usually disappear within 1-2 days without treatment.
Dawn ir- reazzjonijiet ġeneralment jgħibu wara ġurnata jew tnejn mingħajr kura.
If they persist, CONSULT YOUR DOCTOR.
Jekk jippersistu, IKKONSULTA LIT- TABIB TIEGĦEK.
(in more than 1 out of 1,000 people, but less than 1 in 100).
(f' aktar minn 1 minn kull 1, 000 persuna, iżda anqas minn 1 f' kull 100).
Uncommon side effects may include: generalised skin reactions including itching, bumps on the skin or a non-specific rash.
L- effetti sekondarji mhux komuni jistgħu jinkludu: reazzjonijiet ġeneralizzati tal- ġilda fosthom ħakk, nefħiet fuq il- ġilda jew raxx mhux speċifiku.
Rare (in more than 1 out of 10,000 people, but less than 1 in 1,000).
(f' aktar minn 1 minn kull 10, 000 persuna, iżda anqas minn 1 f' kull 1, 000).
Rare side effects include: numbness or tingling sensations, involuntary muscle contractions or transient thrombocytopenia (a low platelet count in the blood which can result in bleeding or bruising).
L- effetti sekondarji rari jinkludu: tirżiħ jew sensazzjonijiet ta 'tnemnim, kontrazzjonijiet involontarji tal- muskoli jew trombocitopenia temporanja (għadd baxx ta' pjastrini fid- demm li jista 'jwassal għal fsada jew tbenġil).
Allergic reactions may occur following vaccination, in rare cases leading to shock.
Jistgħu iseħħu reazzjonijiet allerġiċi wara tilqima, li f' xi każi jistgħu jwasslu għal xokk.
Doctors are aware of this possibility and have emergency treatment available for use in such cases.
It- tobba huma konxji ta 'din il- possibbilta' u għandhom trattament ta 'emerġenza sabiex jintuża f' każijiet simili.
Very rare (in less than 1 in 10,000).
(f' anqas minn 1 minn kull 10, 000).
Very rare side effects include: vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) and exudative Stevens-Johnson syndrome (erythema multiforme).
L- effetti sekondarji rari ħafna jinkludu: vasculitis (infjammazzjoni tal- vini li tista 'tikkawża raxxijiet tal- ġilda, uġigħ fil- ġogi u problemi fil- kliewi) u s - sindrome li jnixxi ta' Stevens- Johnson (eritema multiformi).
Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome.
Mard newroloġiku bħal enċefalomajelite (infjammazzjoni tas- sistema nervuża ċentrali), nevrite (infjammazzjoni tan- nervi) u tip ta 'paralisi magħrufa bħala s- Sindrome ta' Guillain- Barré.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE FOCETRIA
KIF TAĦŻEN FOCETRIA
Do not use Focetria after the expiry date which is stated on the carton and the label after EXP.
Tużax Focetria wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa wara JIS.
Store in the original package in order to protect from light.
Żomm fil- pakkett oriġinali sabiex tilqa 'mid- dawl.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall - protezzjoni ta 'l- ambjent.
What Focetria contains
37 X' fih Focetria
- Active Substance:
- Sustanza attiva:
36 Focetria does not contain live virus particles and so it cannot cause Pandemic influenza.
Focetria ma fihx partikoli tal- virus ħaj u għalhekk ma jistax jikkawża l- influwenza Pandemika.
The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).
L- ingredjenti attivi tal- vaċċin huma proteini virali ppurifikati (msejjħa haemagglutinin u neraminidase).
They are isolated from the surface of influenza virus particles, which are grown in hen’ s eggs and inactivated with formaldehyde.
Dawn jiġu iżolati mill- wiċċ tal- partikuli tal- virus ta 'l- influwenza, li jitkabbru fil - bajd tat- tiġieġ u jiġu diżattivati bil- formaldehyde.
These viral proteins are prepared from the strain of influenza virus that complies with the WHO recommendations and EU decision in an officially declared Pandemic situation.
Dawn il- proteini virali huma ppreparati mill - għamla ta 'virus ta' l- influwenza li tikkonforma mar- rakkomandazzjonijiet tal- WHO u d - deċiżjoni ta 'l- UE f' sitwazzjoni Pandemika ddikjarata b' mod uffiċjali.
One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
Doża waħda (0. 5 ml) tal- vaċċin fiha mill- anqas 7. 5 mikrogrammi ta 'haemagglutinin mill - għamla segwenti rakkomandata ta' virus ta 'l- influwenza:
- Adjuvant:
- Sustanza adjuvanti:
The vaccine contains an ‘ adjuvant’ (a compound containing squalene) to stimulate a better response.
Il- vaċċin fih ‘ sustanza adjuvanti ’ (kompost li fih squalene) biex jistimula rispons aħjar.
The adjuvant includes also polysorbate 80 and sorbitan trioleate in a citrate buffer.
Is - sustanza adjuvanti tinkludi wkoll polysorbate 80 u sorbitan trioleate f' citrate buffer.
- Other Ingredients:
- Sustanzi oħra:
The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Is- sustanzi l- oħra huma: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid u ilma għall- injezzjonijiet.
What Focetria looks like and contents of the pack Focetria is a milky-white liquid.
Focetria huwa likwidu abjad lewn il- ħalib.
It is provided in a ready-to-use syringe, containing a single dose (0.5 ml) for injection, Not all pack sizes may be marketed.
Huwa fornut: f' siringa lesta għall- użu li tesa 'doża waħda (0. 5 ml) għall- injezzjoni.
Marketing Authorisation Holder Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italy.
Id- Detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, L- Italja.
Manufacturer Novartis Vaccines and Diagnostics S. r. l. - Loc.
Manifattur Novartis Vaccines and Diagnostics S. r. l. - Loc.
Bellaria - 53018 Rosia – Sovicille (SI), Italy
Bellaria - 53018 Rosia – Sovicille (SI), L- Italja
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f '{XX/ SSSS}.
Focetria has been authorised under “ Exceptional Circumstances”.
Focetria kien awtorizzat taħt “ Cirkustanzi Eċċezzjonali ”.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Dan ifisser li għal raġunijiet xjentifiċi kien impossibbli li tinkiseb informazzjoni kompleta dwar din il - mediċina.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ kull sena u dan il- fuljett ser jiġi aġġornat,, skond il- bżonn.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
37 PACKAGE LEAFLET:
38 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER
Focetria suspensjoni għall- injezzjoni
Focetria suspension for injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Vaċċin kontra l- Influwenza Pandemika (antiġen tal- wiċċ, inattivat, adjuvantat)
Read all of this leaflet carefully before you start receiving this medicine.
Aqra dan il- fuljett kollu qabel tibda tirċievi din il- mediċina.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex
tell your doctor.
imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
What Focetria is and what it is used for 2.
X' inhu Focetria u għalxiex jintuża 2.
Before you receive Focetria 3.
Qabel ma tirċievi Focetria 3.
How to receive Focetria 4.
Kif għandek tirċievi Focetria 4.
Possible side effects 6.
Effetti sekondarji li jista 'jkollu 6.
How to store Focetria 6.
Kif taħżen Focetria 6.
Take special care with FOCETRIA if you:
Oqgħod attent ħafna b' Focetria jekk inti: