qanastek/EMEA-V3 huggingface dataset:
If you have stopped using Icandra due to surgery (you should stop at least 48 hours before planned surgery with general anesthesia and should not start again until at least 48 hours afterwards) or due to an x-ray involving an injectable dye, talk to your doctor before taking Icandra again.
Jekk waqaft tuża Icandra minħabba operazzjoni (għandek twaqqfu mill- anqas 48 siegħa qabel ma tkun ippjanata l- operazzjoni b’ loppju ġenerali u m’ għandekx terġa ’ tibdih sa mill- anqas 48 siegħa wara) jew minħabba raġġi- x li jinvolvu l- injezzjoni ta ’ kimika bil- kulur, tkellem mat- tabib tiegħek qabel terġa tibda tieħu Icandra.
A test to determine your liver function will be performed before the start of Icandra treatment, at three- month intervals for the first year and periodically thereafter.
Test sabiex tiġi stabbilita l- funzjoni tal- fwied tiegħek se ssir qabel ma tibda l- kura b’ Icandra, f’ intervalli ta ’ tlett xhur fl- ewwel sena u darba kulltant minn hemm ’ l quddiem.
Elderly patients (65-74 years) taking Icandra should have their kidney function monitored regularly.
Pazjenti anjzani (65- 74 sena) li qed jieħdu Icandra għandu jkollhom il- funzjoni tal- fwied immonitorata b’ mod regolari.
Icandra is not recommended for patients aged 75 years or older.
Icandra mhux rakkomandat għal pazjenti li għandhom 75 sena jew aktar.
48 Pregnancy and breast-feeding
48 Meta tieħu Icandra ma ’ l- ikel u max- xorb Ħu l- pilloli ma ’ l- ikel jew eżatt wara l- ikel.
Your doctor will discuss with you the potential risk of taking Icandra during pregnancy.
It- tabib tiegħek ser jiddiskuti miegħek dwar ir- riskju li jista ’ jkun hemm jekk tieħu Icandra waqt it- tqala.
- Do not use Icandra if you are breast-feeding.
- Tużax Icandra jekk qed tredda ’.
Driving and using machines If you feel dizzy while taking Icandra, do not drive or use any tools or machines.
Sewqan u tħaddim ta ’ magni Jekk tħossok sturdut meta tkun qed tieħu Icandra, mgħandekx issuq jew tuża l- ebda għodda jew magni.
HOW TO TAKE ICANDRA
KIF GĦANDEK TIEĦU ICANDRA
Always take Icandra exactly as your doctor has told you.
Dejjem għandek tieħu Icandra skond il- parir tat- tabib.
How much to take The amount of Icandra that people have to take varies depending on their condition.
Kemm għandek tieħu L- ammont ta ’ Icandra li n- nies għandhom jieħdu jvarja skond il- kondizzjoni tagħhom.
Your doctor will tell you exactly the dose of Icandra to take.
It- tabib tiegħek ser jgħidlek eżattament id- doża ta ’ Icandra li għandek tieħu.
When and how to take Icandra
Meta u kif għandek tieħu Icandra
In particular, if you are following a diabetic weight control diet, continue with this while you are taking Icandra.
B’ mod partikolari, jekk qed issegwi dieta ta ’ kontroll tal- piż għad- dijabete, kompli b’ din waqt li qed tieħu Icandra.
If you take more Icandra than you should If you take too many Icandra tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Jekk tieħu Icandra aktar milli suppost Jekk tieħu wisq pilloli Icandra, jew jekk xi ħadd ieħor jieħu l- pilloli tiegħek, kellem lit- tabib jew l - ispiżjar tiegħek mill- ewwel.
If you forget to take Icandra If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway.
Jekk tinsa tieħu Icandra Jekk tinsa tieħu pillola, ħudha ma ’ l- ikla li jkun imissek sakemm ma tkunx wasalt sabiex tieħu oħra xorta waħda.
If you stop taking Icandra Do not stop taking Icandra unless your doctor tells you to.
Jekk tieqaf tieħu Icandra Tieqafx tieħu Icandra sakemm it- tabib tiegħek ma jgħidlekx biex tgħamel hekk.
Like all medicines, Icandra can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Icandra jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects may occur with certain frequencies, which are defined as follows: • very common: affects more than 1 patient in 10 • common: affects 1 to 10 patients in 100 • uncommon: affects 1 to 10 patients in 1,000 49 • rare: affects 1 to 10 patients in 10,000 • very rare: affects less than 1 patient in 10,000 • not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu iseħħu b’ ċerti frekwenzi, li huma definiti kif imiss: • komuni ħafna: jaffettwaw aktar minn pazjent 1 f’ 10 • komuni: jaffettwaw 1 sa 10 pazjenti f’ 100 • mhux komuni: jaffettwaw 1 sa 10 pazjenti f’ 1, 000 • rari: jaffettwaw 1 sa 10 pazjenti f’ 10, 000 • rari ħafna: jaffettwaw anqas minn pazjent 1 f’ 10, 000 • mhux magħruf: il- frekwenza ma tistax tittieħed stima mid- data disponibbli.
Some symptoms need immediate medical attention You should stop taking Icandra and see your doctor immediately if you experience the following side effects:
Xi sintomi jista ’ jkollhom bżonn attenzjoni medika immedjata Għandek tieqaf tieħu Icandra u tara t- tabib tiegħek mill- ewwel jekk tħoss kwalunkwe minn dawn l - effetti sekondarji:
Other side effects Some patients have experienced the following side effects while taking Icandra:
Effetti sekondarji oħrajn Xi pazjenti kellhom l- effetti sekondarji li ġejjin meta kienu qed jieħdu Icandra:
HOW TO STORE ICANDRA
KIF TAĦŻEN ICANDRA
- Do not use Icandra after the expiry date which is stated on the blister and carton.
- Tużax Icandra wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
What Icandra contains
X’ fih Icandra
- Each Icandra 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg
- Kull pillola miksija b’ rita ta ’ Icandra fiha 50 mg vildagliptin u 850 mg metformin hydrochloride
- Each Icandra 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg
- Kull pillola miksija b’ rita ta ’ Icandra fiha 50 mg vildagliptin u 1000 mg metformin
What Icandra looks like and contents of the pack Icandra 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Id- Dehra ta ’ Icandra u l- kontenuti tal- pakkett Icandra 50 mg/ 850 mg pilloli miksijin b’ rita huma pilloli sofor, ovali b ’ “ NVR ” fuq naħa waħda u “ SEH ” fuq l- oħra.
Icandra 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Icandra 50 mg/ 1000 mg pilloli miksijin b’ rita huma pilloli sofor skuri, ovali b ’ “ NVR ” fuq naħa waħda u “ FLO ” fuq l- oħra.
Icandra is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi- packs containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Icandra jiġi f’ pakketti li jkun fihom 10, 30, 60, 120, 180 jew 360 pillola miksija b’ rita u f’ pakketti b’ ħafna li jkun fihom 120 (2x60), 180 (3x60) jew 360 (6x60) pillola miksija b’ rita.
What is IDflu?
X’ inhu IDflu?
IDflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
IDflu hu vaċċin li jiġi bħala sospensjoni għall- injezzjoni f' siringa mimlija minn qabel.
The vaccine contains fragments of influenza (flu) viruses that have been inactivated (killed).
Fih partijiet ta ’ vajrusis tal- influwenza li ġew diżattivati (maqtula).
IDflu contains three different strains (types) of influenza virus (A/ New Caledonia/ 20/ 99, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
IDflu fih tliet tipi differenti ta ’ vajrus tal - influwenza (A/ New Caledonia/ 20/ 99, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
What is IDflu used for?
Għal xiex jintuża IDflu?
IDflu is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications of the disease.
IDflu jintuża fit- tilqim ta 'l- adulti kontra l- influwenza, speċjalment dawk li jkollhom riskju akbar li jiżviluppaw komplikazzjonijiet tal- marda.
The use of the vaccine should be based on official recommendations.
L- użu tal- vaċċin għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.
Adults up to the age of 59 years receive the lower strength (containing 9 micrograms of each virus strain).
Adulti sal- età ta ’ 59 sena jingħataw il- mediċina bil- qawwa iktar baxxa (li fiha 9 mikrogrammi ta ’ kull tip ta ’ vajrus).
People aged 60 years and over receive the higher strength (15 micrograms of each virus strain).
Persuni minn 60 sena ’ l fuq jingħataw qawwa ogħla tal - mediċina (15 mikrogramma ta ’ kull tip ta ’ vajrus).
How is IDflu used?
Kif jintuża IDflu?
IDflu is given as one ‘ intradermal’ injection into the upper layer of the skin, using a special micro-injection system.
IDflu jingħata bħala injezzjoni ‘ intradermali ’ fis- saff ta ’ fuq tal- ġilda bl- użu ta ’ sistema speċjali ta ’ mikroinjezzjoni.
The shoulder is the recommended site of injection.
Is- sit rakkomandat għall- injezzjoni huwa l- ispalla.
How does IDflu work?
Kif jaħdem IDflu?
IDflu is a vaccine.
IDflu huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi 'jgħallmu' lis- sistema immunitarja (id- difiżi naturali tal - ġisem) kif tiddefendi lilha nfisha kontra marda.
IDflu contains fragments from three different strains of flu virus.
IDflu fih frammenti minn tliet tipi differenti tal- vajrus tal- influwenza.
When a person is given the vaccine, the immune system recognises the virus fragments as ‘ foreign’ and makes antibodies against them.
Meta persuna tingħata l- vaċċin, is- sistema immunitarja tagħraf il- frammenti tal- vajrus bħala 'barranin' u tipproduċi antikorpi kontrihom.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains.
Fil- futur, is- sistema immunitarja tkun tista 'tipproduċi antikorpi iktar malajr meta tkun esposta għal kwalunkwe minn dawn it- tipi ta ’ vajrus.
The antibodies will then help to protect against the disease caused by these strains of flu virus.
L - antikorpi mbagħad jgħinu biex jipproteġu kontra l- mardiet ikkawżati minn dawn it- tipi tal- vajrus tal - influwenza.
Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season.
Kull sena, l- Organizzazzjoni Dinjija tas- Saħħa (WHO) tagħmel rakkomandazzjonijiet fuq liema tipi għandhom jiġu inklużi fil- vaċċini għall- istaġun tal- influwenza ta 'wara.
These virus strains need to be included in IDflu before the vaccine can be used.
Dawn it- tipi tal- vajrus għandhom jiddaħħlu f’ IDflu qabel ma jista ’ jintuża l- vaċċin.
IDflu currently contains fragments of the virus strains that were expected to cause flu in the 2006/ 2007 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU).
Bħalissa, IDflu fih frammenti tat- tipi tal - vajrus li kienu mistennija jikkawżaw l- influwenza fl- istaġun 2006/ 2007, skont ir- rakkomandazzjonijiet mill- WHO għall- emisfera tat- tramuntana u mill- Unjoni Ewropea (UE).
The virus strains in IDflu will need to be replaced again before the vaccine can be used in subsequent seasons.
Jeħtieġ li t- tipi tal- vajrus f' IDflu jiġu sostitwiti għal darb' oħra qabel ma jkun jista 'jintuża l- vaċċin fl- istaġuni sussegwenti.
How has IDflu been studied?
Kif ġie studjat IDflu?
The effects of IDflu were first tested in experimental models before being studied in humans.
L- effetti ta 'IDflu għall- ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fil - bniedem.
Four studies involving over 8,000 people were carried out to study the effectiveness of IDflu in protecting against flu.
Twettqu erba ’ studji li kienu jinvolvu 8, 000 persuna sabiex tiġi eżaminata l- effikaċja ta ’ IDflu fil - prevenzjoni tal- influwenza.
Two of the studies looked at people under the age of 60 years, who were vaccinated with the 9-microgram strength.
Żewġ studji minnhom eżaminaw persuna taħt l- età ta ’ 60 sena, li kienu tlaqqmu bil- qawwa ta ’ 9 mikrogrammi.
The other two studies looked at people aged 60 years and over, who were vaccinated with the 15-microgram strength.
Iż- żewġ studji l- oħra eżaminaw persuni minn 60 ’ l fuq, li tlaqqmu bil- qawwa ta ’ 15 mikrogramma.
In all of the studies, IDflu was compared with another flu vaccine given by injection into a muscle.
Fl- istudji kollha, IDflu tqabbel ma ’ vaċċin ieħor kontra l- influwenza li jingħata bħala injezzjoni fil - muskolu.
The studies compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before injection and three weeks afterwards.
L- istudji qabblu l- kapaċità taż- żewġ vaċċini li jistimulaw il- produzzjoni ta 'antikorpi (immunoġeniċità), billi qabbel il- livelli tal- antikorpi qabel l- injezzjoni ma' dawk ta 'tliet ġimgħat wara.
What benefit has IDflu shown during the studies?
X’ benefiċċji wera IDflu matul l- istudji mwettqa?
In all studies, both IDflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
Fl- istudji kollha, kemm IDflu kif ukoll il- vaċċin ta ’ tqabbil kisbu livelli xierqa ta ’ antikorpi għall - protezzjoni kontra t- tliet tipi tal- vajrus tal- influwenza.
In adults below 60 years, the 9-microgram strength provided as good a level of protection as the intramuscular vaccine.
Fl- adulti ta ’ taħt is- 60 sena, il- qawwa ta ’ 9 mikrogrammi li tingħata hija ta ’ livell ta ’ protezzjoni tajba daqs il- vaċċin intramuskolari.
In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the intramuscular vaccine.
Fil- persuni minn 60 sena ’ l fuq, il- qawwa ta ’ 15– il mikrogramma li tingħata tipprovdi livell ta ’ protezzjoni tajba daqs il- vaċċin intramuskolari.
What is the risk associated with IDflu?
X’ inhu r- riskju assoċjat ma ’ IDflu?
The most common side effects with IDflu (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), malaise (feeling unwell) and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
L- effetti sekondarji l- aktar komuni b’ IDflu (li dehru f' aktar minn pazjent 1 minn 10) huma wġigħ ta 'ras, mijalġija (uġigħ fil- muskoli), telqa mingħajr raġuni partikolari u reazzjonijiet fil- punt tal - injezzjoni (ħmura, nefħa, twebbis tal- ġilda, uġigħ u ħakk).
For the full list of all side effects reported with IDflu, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati ma ’ IDflu, ara l- Fuljett ta ’ Tagħrif.
IDflu should not be used in people who may be hypersensitive to the active substances, any of the other ingredients, egg, chicken protein, neomycin (an antibiotic), formaldehyde (a preservative) or octoxinol 9 (a detergent).
IDflu ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi għas- sustanzi attivi, kwalunkwe mis - sustanzi l- oħra, bajd, proteina tat- tiġieġ, neomiċina (neomycin - antibijotiku), formaldehyde (priżervattiv) jew octoxinol 9 (deterġènt).
People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.
Il- vaċċin ma għandux jingħata fil- persuni li jkollhom id - deni jew infezzjoni akuta (li tgħaddi malajr) sakemm dawn ma jkunux irkupraw.
Why has IDflu been approved?
Għaliex ġie approvat IDflu?
The Committee for Medicinal Products for Human Use (CHMP) decided that IDflu’ s benefits are greater than its risks for the prophylaxis of influenza in adults up to 59 years of age and in individuals 60 years of age and over, especially those who run an increased risk of associated complications.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ IDflu huma ikbar mir- riskji tiegħu għall- profilassi tal- influwenza fl- adulti sal- età ta ’ 59 sena u individwi minn 60 sena ’ l fuq, partikolarment dawk li qegħdin fir- riskju ikbar ta ’ komplikazzjonijiet assoċjati.
The Committee recommended that IDflu be given marketing authorisation.
Il- Kumitat irrakkomanda li IDflu tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about IDflu:
Tagħrif ieħor dwar IDflu:
The European Commission granted a marketing authorisation valid throughout the EU for IDflu to Sanofi Pasteur SA on 24 February 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE, għal IDflu lil Sanofi Pasteur SA fi 24 ta ’ Frar 2009.
The full EPAR for IDflu can be found here.
L- EPAR sħiħ għal IDflu jista ’ jiġi kkonsultat hawn.
Pharmaceutica l Form
Għamla farmaċewtika
9 microgram/ strain
9 mikrogrammi/ razza Suspensjoni għall - injezzjoni
Intradermal use
Użu intradermali
pre-filled syringe (glass)
siringa mimlija lesta għal l - użu (ħġieġ)
1 pre-filled syringe
1 Siringa mimlija għall- lest
10 pre-filled syringes
10 siringi mimlijien lesti għal l- użu
20 pre-filled syringes
20 siringi mimlijien lesti għal l- użu
15 microgram/ strain
15 mikrogrammi/ razza Suspensjoni għall - injezzjoni
IDflu 9 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
IDflu 9 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat).
Split Influenza virus*, inactivated, containing antigens equivalent to the following strains:
Virus * tal- influwenza maqsum *, inattivat, li fih antiġeni ekwivalenti għar- razez li ġejjin:
A/ New Caledonia/ 20/ 99 (H1N1) like strain (A/ New Caledonia/ 20/ 99 (IVR-116)) 9 micrograms HA**
Razza li tixbaħ lil A/ New Caledonia/ 20/ 99 (H1N1) (A/ New Caledonia/ 20/ 99 (IVR- 116)) 9 mikrogrammi HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain (A/ Wisconsin/ 67/ 2005 (NYMC X-161)) 9 micrograms HA**
Razza li tixbaħ lil A/ Wisconsin/ 67/ 2005 (H3N2) (A/ Wisconsin/ 67/ 2005 (NYMC X- 161)) 9 mikrogrammi HA **
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) 9 micrograms HA**
Razza li tixbaħ lil B/ Malaysia/ 2506/ 2004 (B/ Malaysia/ 2506/ 2004) 9 mikrogrammi HA **
Per 0.1 ml dose
Kull doża ta ’ 0. 1 ml
* propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin
* ippropogat fil- bajd fertilizzat tat- tiġieġ minn gruppi ta ’ tiġieġ f’ saħħithom ** emagglutinin
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2006/ 2007 season.
Dan il- vaċċin hu konformi mar- rakkomandazzjonijiet tal- WHO (Emisferu tat- Tramuntana) u d - deċiżjoni tal- UE għall- istaġun 2006/ 2007.
For a full list of excipients, see section 6.1.
Għall- lista kompleta ta ’ sustanzi mhux attivi ara sezzjoni 6. 1.
Colourless and opalescent suspension.
Suspensjoni bla kulur u opalexxenti.
Prophylaxis of influenza in adults up to 59 years of age, especially in those who run an increased risk of associated complications.
Profilassi tal- influwenza f’ adulti sa 59 sena, speċjalment dawk li qegħdin f’ riskju miżjud ta ’ kumplikazzjonijiet relatati.
The use of IDflu should be based on official recommendations.
L- użu ta ’ IDflu għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.
Adults up to 59 years of age:
Adulti sa 59 sena:
0.1 ml.
0. 1 ml
IDflu is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.
IDflu mhuwiex rakkomandat għall- użu fit- tfal jew f ’ l- adolexxenti taħt it- 18- il minħabba li m’ hemmx data biżżejjed dwar is- sigurta ’ u l- effikaċja.
Immunisation should be carried out by intradermal route.
Il- vaċċin għandu jingħata minn ġol- ġilda.
The recommended site of administration is the region of the deltoid.
Is- sit rakkomandat ta ’ l- għoti hi ż- żona tad- deltojd.
For instructions for use, see section 6.6.
Għal struzzjonijiet dwar l- użu, ara sezzjoni 6. 6.
Hypersensitivity to the active substances, to any of the excipients, to egg, chicken proteins, neomycin, formaldehyde and octoxinol 9.
Sensittività eċċessiva għas- sustanzi attivi, jew għal xi sustanzi mhux attivi, għall- bajd, proteini tat - tiġieg, neomycin, formaldehyde u octoxinol 9.
IDflu does not contain more than 0.05 microgram ovalbumin per dose.
IDflu ma fihx aktar minn 0. 05 mikrogrammi ta ’ ovalbumin f’ kull doża.
Immunisation shall be postponed in subjects with febrile illness or acute infection.
It- tilqim għandu jiġi pospost f’ pazjenti bid- deni jew b’ infezzjoni akuta.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Bħal vaċċini kollha li jistgħu jiġu injettati, il- kura u s- superviżjoni medika adattata għandhom dejjem ikunu disponibbli fil- pront f’ każ ta ’ avveniment anafilattiku wara l- għoti tal- vaċċin.
IDflu should under no circumstances be administered intravascularly.
IDflu m’ għandu taħt l- ebda ċirkustanza jingħata ġol - vini / arteri.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Ir- rispons tal- antikorpi f’ pazjenti b’ immunosuppressjoni endoġena jew iatroġenika tista ’ tkun insuffiċjenti.
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
F’ każ tal- presenza ta ’ likwidu fil- post fejn tingħata l- injezzjoni wara l- għoti tal- vaċċin, il- vaċċin mhuwiex meħtieġ mill- ġdid.
IDflu may be given at the same time as other vaccines.
IDflu jista ’ jingħata fl- istess ħin ma ’ vaċċini oħrajn.
Immunisation should be carried out on separate limbs.
It- tilqim għandu jingħata f’ dirgħajn/ riġlejn differenti.
It should be noted that the adverse reactions may be intensified.
Wieħed għandu jinnota li r- reazzjonijiet avversi jistgħu jiħraxu.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Ir- rispons immunoloġiku jista ’ jonqos jekk il- pazjent ikun qed jieħu kura immunosuppressanti.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Wara l- vaċċin kontra l- influwenza, riżultati tat- test seroloġiku li jkunu pożittivi- foloz billi jintuża l - metodu ELISA biex ikunu osservati l- antikorpi kontra l- HIV- 1, l- Epatite Ċ, u b’ mod speċjali, HTLV - 1, kienu osservati.
The Western Blot technique disproves the false-positive ELISA test results.
It- teknika Western Blot tgiddeb ir- riżultati tat- test ELISA li jkunu pożittivi- foloz.
The transient false positive reactions could be due to the IgM response by the vaccine.
Ir- reazzjonijiet pożittivi foloz li jgħaddu malajr jistgħu jkunu minħabba r- rispons IgM mill- vaċċin.
For IDflu no clinical data on exposed pregnancies are available.
Għal IDflu, m’ hemmx tagħrif kliniku dwar l- użu waqt tqala esposta.
In general data from intramuscular influenza vaccinations in pregnant women do not indicate adverse fetal and maternal outcomes attributable to the vaccine.
B’ mod ġenerali, informazzjoni minn vaċċini ta ’ kontra l- influwenza li jingħataw ġol- muskoli f’ nisa tqal, ma tindikax riżultati avversi għall- fetu u għall- omm, li huma attribwibbli għall- vaċċin.
One animal study with IDflu did not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ fetal development, parturition or postnatal development.
Studju dwar IDflu fuq l- annimali ma indika l- ebda effetti ta ’ ħsara diretti jew indiretti fir- rigward tat- tqala, l- iżvilupp embrijoniku/ fetali, tal- ħlas jew tal- iżvilupp wara t- twelid.
The use of IDflu may be considered from the second trimester of pregnancy.
L- użu ta ’ IDflu jista ’ jkun ikkunsidrat mit- tieni trimestru tat- tqala.
For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Għal nisa tqal b’ kundizzjonijiet mediċi li jżidu r- riskju tagħhom ta ’ kumplikazzjonijiet mill- influwenza, l- għoti tal- vaċċin hu rakkomandat, irrispettivament mill- istadju li fih tkun it- tqala tagħhom.
The vaccine IDflu may be used during breast-feeding.
Il- vaċċin IDflu jista ’ jintuża waqt it- treddigħ.
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
Il- vaċċin mhux mistenni li jipproduċi effett fuq il- ħila biex issuq jew tħaddem magni.
Adverse reactions observed from clinical trials
Reazzjonijiet avversi osservati mill- provi kliniċi
The safety of IDflu has been assessed in 2 open-label randomised clinical trials in which 2,384 vaccinees received an injection of IDflu.
3 Is- sigurtà ta ’ IDflu kienet evalwata f’ 2 studji kliniċi open- label u randomised li fihom 2384 pazjent irċivew injezzjoni ta ’ IDflu.
3 Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up.
L- evalwazzjoni tas- sigurtà twettqet fil- pazjenti kollha matul l- ewwel 3 ġimgħat wara l- vaċċin u avvenimenti avversi serji nġabru matul sitt xhur ta ’ follow- up.
The most common reactions occurring after vaccine administration were local reactions at injection site.
L- iktar reazzjonijiet komuni li seħħew wara l- għoti tal- vaċċin kienu reazzjonijiet lokali fis- sit tal - injezzjoni.
Apparent local reactions after intradermal administration were more frequent than after the comparator vaccine administered intramuscularly.
Reazzjonijiet apparenti lokali wara l- għoti minn ġol- ġilda kienu iktar frekwenti milli wara l- vaċċin komparatur li ngħata ġol- muskoli.
Most reactions resolved spontaneously within 1 to 3 days after onset.
Il- biċċa l- kbira tar- reazzjonijiet għaddew waħidhom fi żmien minn jum sa 3 ijiem wara li bdew.
Systemic safety profile of IDflu is similar to the comparator vaccine administered intramuscularly.
Il- profil tas- sigirtà sistemika ta ’ IDflu hu simili għal dak tal- vaċċin komparatur mogħti ġol- muskoli.
After repetitive yearly injections the safety profile of IDflu is similar to the previous injections.
Wara injezzjonijiet li ngħataw ripetutament kull sena, il- profil tas- sigurtà ta ’ IDflu hu simili għal dak ta ’ injezzjonijiet li ngħataw qabel.
The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination, using the following convention: 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), not known (cannot be estimated from available data).
Id- dejta t’ hawn taħt tagħti l- frekwenzi tar- reazzjonijiet avversi fil- qosor li kienu rrekordjati wara t - tilqim, bl- użu tal- konvenzjoni li ġejja: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1000 sa < 1/ 100); rari (≥1/ 10000 sa < 1/ 1000); rari ħafna (< 1/ 10000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Organ class
Klassi ta ’ l - organu Disturbi tad - demm u tas - sistema limfatika
Uncommon
Mhux Komuni Limfadenopatija
Blood and lymphatic system disorders
Disturbi fis - sistema nervuża
Lymphadenopath y
Uġigħ ta ’ ras
Paresthesia
Parestesija
Pruritus, rash
Ħakk, Raxx
Sweating
Għaraq
General disorders and
Disturbi ġenerali u kundizzjonijiet
Malaise,
Telqa,
Shivering, fever,
Rogħda, deni,
administration site conditions
ta ’ mnejn jingħata
Local reactions: redness*, swelling, induration pain, pruritus
Reazzjonijiet Reazzjonijiet lokali: lokali: ħmura *, ekkimożi nefħa, ebusija, uġigħ, ħakk
* In some cases, local redness lasted up to 7 days
* F’ xi każijiet, il- ħmura damet sa 7 ijiem
Adverse reactions from Post-Marketing surveillance
Reazzjonijiet avversi mis- sorveljanza ta ’ Wara t- Tqegħid fis- Suq
There is no safety data from post-marketing experience with IDflu.
M’ hemm l- ebda dejta dwar is- sigurtà mill- esperjenza ta ’ wara t- tqegħid fis- suq ta ’ IDflu.
However, based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, systemic reactions, not listed above, may be reported:
Madankollu, ibbażat fuq l- esperjenza b’ vaċċini ta ’ kontra l- influwenza inattivati trivalenti mogħtija permezz ta ’ injezzjoni ġol- muskoli jew injezzjoni fonda taħt il- ġilda, reazzjonijiet sistemiċi, mhux elenkati hawn fuq, jistgħu jiġu rrappurtati:
Blood and lymphatic system disorders Transient thrombocytopenia
Disturbi tad- demm u tas- sistema limfatika Tromboċitopenja li tgħaddi malajr
Immune system disorders Allergic reactions, in rare cases leading to shock, angioedema
4 Disturbi fis- sistema immuni Reazzjonijiet allerġiċi, li f’ każijiet rari jwasslu għal xokk, anġjodema
4 Nervous system disorders Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Disturbi fis- sistema nervuża Newralġija, konvulżjonijiet bid- deni, disturbi newroloġiċi bħal enċefalomajelite, nevrite u s- sindrome ta ’ Guillain Barré
Vascular disorders Vasculitis associated in very rare cases with transient renal involvement
Disturbi vaskulari Vaskulite assoċjata ma ’ każijiet rari ħafna ta ’ involviment renali temporanju
Skin and subcutaneous tissue disorders Generalised skin reactions including urticaria
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Reazzjonijiet tal- ġilda ġeneralizzati li jinkludu l- urtikarja
Overdose is unlikely to have any untoward effect.
Doża eċċessiva mhux mistenni li jkollha xi effett negattiv.
Influenza vaccines, ATC code:
Vaċċini ta ’ kontra l- influwenza, Kodiċi ATC:
Seroprotection is generally obtained within 2 to 3 weeks.
Is- seroprotezzjoni ġeneralment tinkiseb fi żmien minn 2 sa 3 ġimgħat.
The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6- 12 months.
It- tul ta ’ żmien ta ’ l- immunità wara l- vaċċin għal razez omologi jew għal razez li huma marbuta mill- qrib mar- razez tal- vaċċin ivarja, iżda normalment hu ta ’ 6- 12 xhur.
In a randomised comparative phase III trial, 1,796 subjects from 18 to 59 years of age received 0.1 ml of IDflu by intradermal route and 453 subjects from 18 to 59 years of age received 0.5 ml of trivalent inactivated influenza vaccine administered by intramuscular route.
Fi studju komparattiv randomised ta ’ fażi III, 1796 persuna li kellhom minn 18 sa 59 sena, irċivew 0. 1 ml ta ’ IDflu minn ġol- ġilda u 453 persuni minn 18 sa 59 sena irċivew 0. 5 ml ta ’ vaċċin ta ’ kontra l- influwenza inattivat trivalenti ġol- muskoli.
In this comparative trial the seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
F’ din il- prova komparattiva, ir- rata tas- seroprotezzjoni *, is- serokonverżjoni jew ir- rata taż- żieda sinifikanti ** u l- medja ġejometrika tal- proporzjon tat- tajter (GMTR) għall- antikorp anti- HA (imkejjel minn HI) kienu evalwati skond kriterji definiti minn qabel.
Data were as follows (values in brackets show the 95% confidence intervals):
5 Id- dejta kienet kif ġej (il- valuri fil- parentesi juru l- intervalli ta ’ kunfidenza ta ’ 95%):
Strain specific anti-HA
Antikorp anti- HA speċifiku
antibody
għar- razza
A/ Wisconsin/ 67/ 2005 N=1,297
Rata ta ’ seroprotezzjoni
B/ Malaysia/ 2506/ 2004 N=1,294
87. 2% 93. 5%
Seroprotection rate
Serokonverżjoni/ Rata taż -
87.2% (85.2, 89.0)
(85. 2, 89. 0) 57. 5%
93.5% (92.0, 94.8)
(92. 0, 94. 8) 66. 5%
72.9% (70.4, 75.3)
(70. 4, 75. 3) 56. 7%
Seroconversion/ Significant increase rate GMTR
żieda sinifikanti
57.5% (54.7, 60.2) 9.17 (8.33, 10.1)
(8. 33, 10. 1)
66.5% (63.8, 69.0) 11.5 (10.4, 12.7)
(10. 4, 12. 7)
56.7% (54.0, 59.4) 6.39 (5.96, 6.84)
(5. 96, 6. 84)
*Seroprotection = HI titre ≥ 40 ** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR:
* Seroprotezzjoni = HI tajter ≥ 40 ** serokonverżjoni = tajter HI ta ’ qabel il- vaċċin u tajter HI ta ’ wara l- vaċċin negattivi ≥ 40, Żieda sinifikanti = tajter HI ta ’ qabel il- vaċċin pożittiv u mill- inqas żieda ta ’ 4 darbiet iżjed fit- tajter ta ’ wara l- vaċċin GMTR:
Geometric mean titre ratio of individual (post-/ pre-vaccination titre).
Medja ġejometrika tal- proporzjon tat- tajter ta ’ l- individwu (tajter ta ’ qabel/ wara l- vaċċin).
IDflu is as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 18 to 59 years of age.
IDflu hu immunoġeniku daqs il- vaċċin komparatur ta ’ kontra l- influwenza inattivat trivalenti li jingħata ġol- muskoli għal kull waħda mit- 3 razez tal- influwenza f’ persuni ta ’ bejn 18 u 59 sena.
5 Across all three influenza strains, for the comparator intramuscular vaccine seroprotection rates ranged between 74.8% and 95.4%, seroconversion or significant increase rates ranged between 56.4% and 69.3% and GMTRs ranged between 6.63 and 11.2-fold over baseline HI titres.
Fuq il- medda tat- tliet razez kollha tal- influwenza, għall- vaċċin komparatur li jingħata ġol- muskoli, ir - rati tas- seroprotezzjoni varjaw bejn 74. 8% u 95. 4%, ir- rata tas- serokonverżjoni jew żieda sinifikanti varjaw bejn 56. 4% u 69. 3%, u l- GMTRs varjaw bejn 6. 63 u 11. 2- il darba fuq it- tajter HI fil- linja bażi.
Non-clinical data revealed no special hazard for humans based on animal studies.
Informazzjoni li mhix klinika ma turi l- ebda periklu speċjali għall- bnedmin, magħmula fuq studji fuq l- annimali.
The vaccine was immunogenic in mice and rabbits.
Il- vaċċin kien immunoġeniku fil- ġrieden u l- fniek.
In repeated-dose toxicity studies in rabbits there was no significant evidence of systemic toxicity.
Studji dwar it- tossiċità meta jingħataw dożi ripetuti fil- fniek, ma kien hemm l- ebda evidenza ta ’ tossiċità sistemika.
Nevertheless, single and repeated administration led to transient local erythema and oedema.
Madankollu, l- għoti ta ’ vaċċin wieħed u ta ’ vaċċini ripetuti, wasslu għal eritema u edema lokali temporanji.
Genotoxicity and carcinogenic potential were not assessed because these studies are not appropriate for a vaccine.
Il- ġenotossiċità u l- potenzjal karċinoġeniku ma kinux evalwati minħabba li dawn l- istudji mhumiex adattati għal vaċċin.
Fertility and toxicity studies to reproduction in females have not identified any specific potential hazard for humans.
Studji dwar il- fertilità u t- tossiċità lir- riproduzzjoni fin- nisa ma żvelaw l- ebda periklu potenzjali speċifiku għall- bnedmin.
Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Ilma għall- injezzjonijiet
6.3 Shelf-life
6 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
1 year
Sena
Store in a refrigerator (2°C-8°C).
Aħżen fi friġġ (2°C- 8°C).
Keep the syringe in the outer carton in order to protect from light.
Żomm is- siringa fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
0.1 ml of suspension in a pre-filled syringe (type I glass) with a Micro-Injection System, with attached micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic elastomer and polypropylene) and a needle shielding system.
0. 1 ml ta ’ suspensjoni f’ siringa mimlija għall- lest (ħġieġ ta ’ tip I) b’ Sistema ta ’ Mikro- Injezzjoni, b’ labra mikro mwaħħla, mgħammra b’ tapp tal- planġer tal- elastomer (chlorobutyl), għatu tat- tarf (elastomer termoplastiku u polypropylene) u sistema tal- protezzjoni tal- labra.
Pack size of 1 or 10 or 20.
Daqs tal- pakkett ta ’ 1 jew 10 jew 20.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Kwalunkwe vaċċin mhux użat jew materjal ieħor għar- rimi għandu jintrema skond il- liġijiet lokali.
The vaccine should be allowed to reach room temperature before use.
Il- vaċċin għandu jitħalla jilħaq it- temperatura tal- kamra qabel l- użu.
The vaccine should not be used if foreign particles are present in the suspension.
Il- vaċċin m’ għandux jintuża jekk ikun hemm il- frak fis- suspensjoni.
6 It is not necessary to shake the vaccine before use.
M’ hemmx bżonn iċċaqlaq il- vaċċin qabel l- użu.
The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro- needle (1.5 mm) and a needle shielding system.
Is- Sistema ta ’ Mikro- Injezzjoni għal injezzjoni minn ġol- ġilda tikkonsisti f’ siringa mimlija għall- lest b’ labra mikro (1. 5 mm) u sistema tal- protezzjoni tal- labra.
The needle shielding system is designed to cover the micro-needle after use.
Is- sistema tal- protezzjoni tal- labra hi maħsuba biex tgħatti l- labra mikro wara l- użu.
Micro-Injection System
Sistema ta ’ Mikro- Injezzjoni
Micro-needle
Labra mikro
Finger pads
subgħajn
Plunger
Planġer
Window
Tieqa
Needle shield
Protezzjoni tal - labra
Needle cap
Għatu tal - labra
Vaccine
Vaċċin
Flange
Flanġ
7 INSTRUCTIONS FOR USE
7 STRUZZJONIJIET GĦALL- UŻU
2/ HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB & MIDDLE FINGER
Jekk jogħġbok aqra l- istruzzjonijiet 2 / ŻOMM IS- SISTEMA TA 'MIKRO- INJEZZJONI 1 / NEĦĦI L- GĦATU TAL- LABRA
cap from the Micro-Injection System.
Neħħi l- għatu tal - labra mis - Sistema ta 'Mikro - Injezzjoni.
Hold the system by placing the thumb and middle finger only on the finger pads; the
BEJN IS- SABA 'L- KBIR U DAK TAN- NOFS Żomm is- sistema billi tpoġġi s- saba' l- kbir u s- saba 'tan- nofs biss fuq il- pads tas - subgħajn; is- saba' l -
Do not purge air through the needle.
Tneħħix l- arja minn ġol- labra.
index finger remains free.
werrej jibqa 'ħieles.
Do not place fingers on the windows.
Tpoġġix subgħajk fuq it- twieqi.
3/ INSERT NEEDLE RAPIDLY PERPENDICULAR TO THE SKIN
3 / DAĦĦAL IL- LABRA MALAJR B' MOD PERPENDIKULARI MAL- ĠILDA
4/ INJECT USING THE INDEX FINGER Once the micro-needle
4 / INJETTA BILLI TUŻA S- SABA 'L- WERREJ
Insert the needle perpendicular to the skin, in the region of the deltoid, in a short, quick movement.
Daħħal il- labra b' mod perpendikulari mal- ġilda, fiż- żona tad- deltojd, b' movimement qasir u mgħaġġel.
has been inserted, maintain a light pressure on the surface of the skin and inject using the index finger to push on the plunger.
Ġaladarba l- labra mikro tkun iddaħħlet, applika pressjoni ħafifa fuq wiċċ il- ġilda u injetta billi tuża s - saba 'l- werrej biex tagħfas fuq il- planġer.
The vein test is unnecessary.
It- test tal- vina mhuwiex meħtieġ.
5/ ACTIVATE NEEDLE SHIELD BY PUSHING FIRMLY ON PLUNGER Remove the needle from the skin.
5 / ATTIVA L- PROTEZZJONI TAL- LABRA BILLI TAGĦFAS BIS- SAĦĦA FUQ IL- PLANĠER
Orient the needle away from you and others.
Neħħi l- labra minn ġol- ġilda.
With the same hand, push very firmly with the thumb on the plunger to activate the needle shield.
Dawwar il- labra lilhemm minnek u minn persuni oħrajn.
You hear a click and a shield comes out to cover the needle.
Bl- istess id, agħfas bis- saħħa ħafna bis- saba 'l- kbir fuq il- planġer biex tattiva l- protezzjoni tal- labra.
Immediately dispose of the system in the nearest sharps collector.
Ser tisma 'klikk u l- protezzjoni toħroġ biex tiksi l- labra.
Click Injection is considered successful whether or not the presence of a wheal is observed.
Armi immedjatament is- sistema fl- eqreb kontenitur għal oġġetti bil - ponta.
Activated needle shield
Attiva l- protezzjoni tal- labra
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
F’ każ tal- preżenza ta ’ likwidu fil- post fejn tingħata l- injezzjoni wara l- għoti tal- vaċċin, il- vaċċin mhuwiex meħtieġ mill- ġdid.
MARKETING AUTHORISATION HOLDER
NUMRU( I) TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TAL- EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website tal- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
IDflu 15 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
IDflu 15 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat).
A/ New Caledonia/ 20/ 99 (H1N1) like strain (A/ New Caledonia/ 20/ 99 (IVR-116)) 15 micrograms HA**
Razza li tixbaħ lil A/ New Caledonia/ 20/ 99 (H1N1) (A/ New Caledonia/ 20/ 99 (IVR- 116)) 15 mikrogrammi HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain (A/ Wisconsin/ 67/ 2005 (NYMC X-161)) 15 micrograms HA**
Razza li tixbaħ lil A/ Wisconsin/ 67/ 2005 (H3N2) (A/ Wisconsin/ 67/ 2005 (NYMC X- 161)) 15 mikrogrammi HA **
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) 15 micrograms HA**
Razza li tixbaħ lil B/ Malaysia/ 2506/ 2004 (B/ Malaysia/ 2506/ 2004) 15 mikrogrammi HA **
Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
Profilassi tal- influwenza f’ adulti minn 60 sena l- fuq, speċjalment dawk li qegħdin f’ riskju miżjud ta ’ kumplikazzjonijiet relatati.
Individuals 60 years of age and over:
Adulti minn 60 sena l- fuq:
10 4.3 Contraindications
10 4. 3 Kontra- indikazzjonijiet
This vaccine is intended for individuals 60 years of age and over.
Dan il- vaċċin huwa indikat f’ adulti ta ’ 60 sena l- fuq.
Therefore, this information is not applicable.
Għalhekk, din l- informazzjoni ma taplikax.
The safety of IDflu has been assessed in 2 open-label randomised clinical trials, 2,974 vaccinees received an injection of IDflu.
Is- sigurtà ta ’ IDflu kienet evalwata f’ 2 studji kliniċi open- label u randomised li fihom 2974 pazjent irċivew injezzjoni ta ’ IDflu.
Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up.
L- evalwazzjoni tas- sigurtà twettqet fil- pazjenti kollha matul l- ewwel 3 ġimgħat wara l- vaċċin u avvenimenti avversi serji nġabru matul sitt xhur ta ’ follow- up.
Most reactions resolved spontaneously within 1 to 3 days after onset.
11 Il- biċċa l- kbira tar- reazzjonijiet għaddew waħidhom fi żmien minn jum sa 3 ijiem wara li bdew.
11 Systemic safety profile of IDflu is similar to the comparator vaccine administered intramuscularly.
Il- profil tas- sigirtà sistemika ta ’ IDflu hu simili għal dak tal- vaċċin komparatur mogħti ġol- muskoli.
The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination, using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1000); very rare (< 1/ 10,000), not known (cannot be estimated from available data).
Id- dejta t’ hawn taħt tagħti l- frekwenzi tar- reazzjonijiet avversi fil- qosor li kienu rrekordjati wara t - tilqim, bl- użu tal- konvenzjoni li ġejja: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1000 sa < 1/ 100); rari (≥1/ 10000 sa < 1/ 1000); rari ħafna (< 1/ 10000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Organ class
Klassi ta ’ l - organu
Very common
Komuni Komuni ħafna
Nervous system disorders
Disturbi fis - sistema nervuża
Paresthesia, neuritis
Parestesija, Newrite
Sweating
Għaraq,
Malaise, shivering, fever, Local reactions: ecchymosis
Reazzjonijiet Telqa, Rogħda, lokali: deni, ħmura *, ebusija, Reazzjonijiet nefħa, ħakk, lokali: uġigħ, ekkimożi
*In some cases, local redness lasted up to 7 days.
* F’ xi każijiet, il- ħmura damet sa 7 ijiem
Adverse reactions from Post-Marketing surveillance
Reazzjonijiet avversi mis- sorveljanza ta ’ Wara Tqegħid fis- Suq
There is no safety data from post-marketing experience with IDflu.
M’ hemm l- ebda dejta dwar is- sigurtà mill- esperjenza ta ’ wara tqegħid fis- suq ta ’ IDflu.
Blood and lymphatic system disorders Transient thrombocytopenia, transient lymphadenopathy
Disturbi tad- demm u tas- sistema limfatika Tromboċitopenja li tgħaddi malajr, limfadenopatija temporanja
Immune system disorders Allergic reactions, in rare cases leading to shock, angioedema
Disturbi fis- sistema immuni Reazzjonijiet allerġiċi, li f’ każijiet rari jwasslu għal xokk, anġjodema
Nervous system disorders Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain Barré syndrome
Disturbi fis- sistema nervuża Newralġija, konvulżjonijiet bid- deni, disturbi newroloġiċi bħal enċefalomajelite, u s- sindrome ta ’ Guillain Barré
12 4.9 Overdose
12 4. 9 Doża eċċessiva
In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of IDflu by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
Fi studju pivotali randomised komparattiv ta ’ fażi III, 2606 persuna l- fuq minn 60 sena, irċivew 0. 1 ml ta ’ IDflu minn ġol- ġilda u 1089 persuni l- fuq minn 60 sena irċivew 0. 5 ml ta ’ vaċċin ta ’ kontra l - influwenza inattivat trivalenti ġol- muskoli.
In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
F’ din il- prova komparattiva, it- tajters medji ġejometriċi (GMTs), ir- rata tas- seroprotezzjoni *, is - serokonverżjoni jew ir- rata taż- żieda sinifikanti ** u l- medja ġejometrika tal- proporzjon tat- tajter (GMTR) għall- antikorp anti- HA (imkejjel minn HI) kienu evalwati skond kriterji definiti minn qabel.
Data were as follows (values in brackets show the 95% confidence intervals):
Id- dejta kienet kif ġej (il- valuri fil- parentesi juru l- intervalli ta ’ kunfidenza ta ’ 95%):
Intradermal 15µg
15µg minn ġol- ġilda
Geometric mean of titre
Medja ġejometrika tat- tajter
81.7
81. 7
298.0
298. 0
39.9
39. 9
(78.0; 85.6)
(78. 0 - 85. 6)
Seroprotection rate (%) *
Rata ta 'seroprotezzjoni (%) *
77.0
77. 0
93.3
93. 3
55.7
55. 7
(75.3; 78.6)
(75. 3; 78. 6)
(92.3; 94.3)
(92. 3; 94. 3)
(53.8; 57.6)
(53. 8; 57. 6)
Seroconversion or significant increase rate (%) ** Geometric mean of titre ratio (GMTR)
Serokonverżjoni jew rata taż - żieda sinjifikanti (%) **
38.7 (36.8; 40.6) 3.97 (3.77; 4.18)
38. 7 (36. 8; 40. 6)
61.3 (59.3; 63.1) 8.19 (7.68; 8.74)
61. 3 (59. 3; 63. 1)
36.4 (34.5; 38.3) 3.61 (3.47; 3.76)
36. 4 (34. 5; 38. 3)
*Seroprotection = HI titre ≥ 40 ** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR:
** serokonverżjoni = tajter HI ta ’ qabel il- vaċċin u tajter HI ta ’ wara l- vaċċin negattivi ≥ 40, Żieda sinifikanti = tajters HI ta ’ qabel il- vaċċin pożittiv u mill- inqas żieda ta ’ 4 darbiet iżjed fit- tajter ta ’ wara l- vaċċin GMTR:
Geometric mean titre ratio of individual (post-/ pre-vaccination titre).
Medja ġejometrika tal- proporzjon tat- tajter ta ’ l- individwu (tajters ta ’ qabel/ wara l- vaċċin).
IDflu is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of age and over.
IDflu hu mill- inqas immunoġeniku daqs il- vaċċini komparatur ta ’ kontra l- influwenza inattivat trivalenti li jingħata ġol- muskoli għal kull waħda mit- 3 razez tal- influwenza f’ persuni ta ’ 60 sena jew iżjed.
Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 34.8 (1/ dil) and 181.0 (1/ dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 5.35-fold over baseline HI titres.
Fuq il- medda tat- tliet razez kollha tal- influwenza, għall- vaċċin komparatur li jingħata ġol- muskoli, il - GMTs varjaw bejn 34. 8 (1/ dil) u 181. 0 (1/ dil, ir- rati tas- seroprotezzjoni varjaw bejn 48. 9% u 87. 9%,
13 5.2 Pharmacokinetic properties
13 ir- rata tas- serokonverżjoni jew żieda sinifikanti varjaw bejn 30. 0% u 46. 9%, u l- GMTRs varjaw bejn 3. 04 u 5. 35 - darbiet fuq it- tajters HI fil- linja bażi.
Not applicable
5. 2 Tagħrif farmakokinetiku
5.3 Preclinical safety data
Ma jgħoddx f’ dan il- każ.
Nevertheless, single and repeated administrations led to transient local erythema and oedema.
Madankollu, l- għoti ta ’ vaċċin wieħed u ta ’ vaċċini ripetuti, wasslu għal eritema u edema lokali temporanji.
The vaccine should not be used if foreign particles are present in the suspension.
14 Il- vaċċin m’ għandux jintuża jekk ikun hemm il- frak fis- suspensjoni.