qanastek/EMEA-V3 huggingface dataset:
Once the cartridge is reconstituted it can be stored below 25°C for up to 7 days during the 28 day use time.
Ladarba l - iskartoċċ jiġi rikostitwit, huwa jista ’ jinħażen f’ temperatura taħt 25°C sa 7 ijiem matul il- perjodu ta ’ użu ta ’ 28 ġurnata.
Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Denmark
Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Id- Danimarka
EU/ 1/ 06/ 339/001 2 dual-chamber cartridges per pack.
EU/ 1/ 06/ 339/ 001 2 skrataċ ta ’ żewġ kompartimenti għal kull pakkett.
EU/1/06/339/002 6 dual-chamber cartridges per pack.
EU/ 1/ 06/ 339/ 002 6 skrataċ ta ’ żewġ kompartimenti għal kull pakkett.
Dual chamber cartridge
Skartoċċ ta ’ żewġ kompartimenti
Preotact 100 micrograms powder and solvent for solution for injection Parathyroid hormone Subcutaneous use
Preotact 100 mikrogramm trab u solvent għal soluzzjoni għall- injezzjoni Ormon tal- paratirojde Użu għal taħt il- ġilda
1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses)
1. 61 mg ormon tal- paratirojde u 1. 13 mg ta ’ solvent (14- il doża)
What Preotact is and what it is used for 2.
X’ inhu Preotact u għalxiex jintuża 2.
Before you use Preotact 3.
Qabel ma tuża Preotact 3.
How to use Preotact 4.
Kif għandek tuża Preotact 4.
Possible side effects 5 How to store Preotact 6.
Kif taħżen Preotact 6.
WHAT PREOTACT IS AND WHAT IT IS USED FOR
X’ INHU PREOTACT U GĦALXIEX JINTUŻA
Preotact is used to treat osteoporosis in women past menopause with high risk of fractures.
Preotact jintuża biex tiġi ttrattata l- osteoporożi f’ nisa fil- fażi ta ’ wara l- menopawsa f’ riskju għoli ta ’ ksur.
Osteoporosis is a disease that causes bones to become thin and fragile.
L- osteoporożi hija marda li twassal biex l- għadam jirqaq u jsir fraġli.
It is especially common in women after the menopause.
Hija komuni l- aktar f’ nisa li qabżu l- menopawsa.
The disease progresses gradually so you may not feel any symptoms at first.
Il- marda tavvanza b’ mod gradwali u għalhekk, għall- ewwel, inti tista ’ ma tħoss l- ebda sintomi.
But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists.
Iżda jekk ikollok l- osteoporożi, din tagħmlek aktar suxxettibbli li tikser l- għadam, speċjalment fis- sinsla tiegħek, ġenbek u l- polz.
It may also cause back pain, loss of height, and a curved back.
Tista ’ tikkawża wkoll uġigħ fid- dahar, telf tat- tul, u dahar mgħawweġ.
Preotact reduces the risk of breaking spinal bones because it increases your bone quality and strength.
Preotact inaqqas ir- riskju li tikser l- għadam tas- sinsla minħabba li jżid il- kwalità u s- saħħa ta ’ l - għadam tiegħek.
BEFORE YOU USE PREOTACT
QABEL MA TUŻA PREOTACT
Do not use Preotact: • if you are allergic (hypersensitive) to parathyroid hormone or any of the other ingredients of Preotact; • if you have had radiation therapy to the skeleton; • if you suffer from high calcium levels and other disturbances in the calcium-phosphor metabolism; • if you have other bone disease (including hyperparathyroidism or Paget’s disease); • if you have high levels of alkaline phosphatase; • if you suffer from severe kidney problems; • if you suffer from severe liver disease;
Tużax Preotact: • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- ormon tal- paratirojde jew għal xi sustanzi oħra ta ’ Preotact; • jekk għamilt terapija bir- radjazzjoni għall- iskeletru; • jekk tbati minn livelli għolji ta ’ kalċju u disturbi oħra fil- metaboliżmu tal- kalċju u l- fosfru; • jekk għandek mard ieħor ta ’ l- għadam (inkluż l- iperparatirojdiżmu jew il- marda ta ’ Paget); • jekk għandek livelli għoljin ta ’ alkaline phosphatase; • jekk tbati minn problemi serji fil- kliewi; • jekk tbati minn mard serju tal- fwied;
Measuring of the calcium levels in the blood and/or urine
Kejl tal- livelli tal- kalċju fid- demm u/ jew fl- awrina
Your doctor will check your response to treatment at regular intervals.
It- tabib tiegħek se jiċċekkja r- rispons tiegħek għall- kura f’ intervalli regolari.
He or she must perform blood and/or urine tests at month 1, 3 and 6 after starting your treatment with Preotact.
Hu jew hi jrid jagħmillek testijiet tad- demm fl- 1, it- 3 u s- 6 xahar wara l- bidu tat- trattament tiegħek bi Preotact.
Take special care with Preotact:
Oqgħod attent ħafna bi Preotact:
Preotact should be used with caution if you suffer from kidney stones or have had kidney stones.
Preotact għandu jintuża b’ kawtela jekk inti tbati minn ġebel fil- kliewi jew kellek ġebel fil- kliewi.
Specific populations:
21 Popolazzjonijiet speċifiċi:
20 Children and adolescents
Tfal u adoloxxenti
Preotact should not be used in children or adolescents.
Preotact m’ għandux jintuża fit- tfal jew fl- adoloxxenti.
No special precautions.
Ebda prekawzjonijiet speċjali.
Preotact should be used with caution if you receive heart medicine.
Preotact għandu jintuża b’ attenzjoni jekk qed tirċievi mediċina għall- qalb.
Taking Preotact with food and drink
Meta tieħu Preotact ma ’ l- ikel u max- xorb
Food and drink have no influence on the effect of Preotact.
L- ikel u x- xorb ma jinfluwenzawx l- effett ta ’ Preotact.
Do not use Preotact if you are pregnant or breast-feeding.
Tużax Preotact jekk inti tqila jew qiegħda tredda ’.
No studies on the ability to drive or operate machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
If you feel dizzy, do not drive or operate any machines until you feel better.
Jekk tħossok storduta, inti m’ għandekx issuq jew tħaddem magni qabel ma tħossok aħjar.
Important information about some of the ingredients of Preotact:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Preotact:
This means that it is essentially “sodium-free”.
Dan ifisser li prattikament huwa “ mingħajr sodju ”.
HOW TO USE PREOTACT
KIF GĦANDEK TUŻA PREOTACT
Always use Preotact exactly as your doctor has told you.
Dejjem għandek tuża Preotact skond il- parir tat- tabib tiegħek.
The usual dose of Preotact is 100 micrograms given once a day.
Id- doża normali ta ’ Preotact hija 100 mikrogramm darba kuljum.
Your doctor may advise you to take supplementary calcium and vitamin D.
It- tabib tiegħek jista ’ jagħtik parir biex tieħu kalċju u vitamina D supplimentari.
Your doctor will tell you how much you should take each day.
It- tabib tiegħek se jgħidlek kemm għandek tieħu kuljum.
Preotact should be used with the Preotact pen.
Preotact għandu jintuża mal- pinna Preotact.
When you place the cartridge in the Preotact pen, the solvent and the powder mix.
Meta inti tpoġġi l- iskartoċċ fil- pinna Preotact, is- solvent u t- trab jitħalltu.
The solution is then ready to be injected into the abdomen (under the skin).
Is- soluzzjoni mbagħad tkun lesta biex tiġi injettata fl- addome (taħt il- ġilda).
When not in use put the Preotact pen into the refrigerator.
Meta ma tkunx qed tużaha, poġġi l- pinna Preotact fil - friġġ.
Important information when using Preotact • Inject yourself with Preotact shortly after you have taken the Preotact pen out of the refrigerator
Tagħrif importanti għal meta tuża Preotact
21 • Put the Preotact pen back into the refrigerator immediately after you have used it.
22 • Injetta lilek innifsek bi Preotact ftit wara li toħroġ il- pinna Preotact mill- friġġ • Erġa ’ poġġi l- pinna Preotact fil- friġġ immedjatament wara li tużaha.
Never remove a cartridge in use from the pen. • DO NOT SHAKE the Preotact pen (neither before nor after injection) as it may destroy the effect of the active substance • Use a new injection needle for each injection and throw it away after each use. • Never store your Preotact pen with the needle attached. • Never share your Preotact pen with anyone.
Qatt tneħħi skartoċċ waqt l- użu mill- pinna • TĦAWWADX il- pinna Preotact (la qabel u lanqas wara l- injezzjoni) billi dan jista ’ jeqred l - effett tas- sustanza attiva • Uża labra ta ’ l- injezzjoni ġdida għal kull injezzjoni u armiha wara kull użu • Qatt m’ għandek taħżen il- pinna Preotact tiegħek bil- labra mwaħħla • Qatt m’ għandek taqsam il- pinna Preotact tiegħek ma ’ ħaddieħor.
For instructions on how to use the Preotact pen, please read the User Manual of the Preotact pen.
Għal struzzjonijiet dwar kif għandek tuża l- pinna Preotact, jekk jogħġbok aqra l- Manwal għall- Utent tal- pinna Preotact.
Keep using Preotact for as long as your doctor prescribes it for you – normally no longer than 24 months.
Kompli uża Preotact għaż- żmien kollu li qallek it- tabib tiegħek – normalment mhux aktar minn 24 xahar.
If you use more Preotact than you should:
Jekk tuża Preotact aktar milli suppost:
If, by accident, you inject more than one dose of Preotact in a day, contact your doctor or pharmacist.
Jekk, bi żball, tinjetta aktar minn doża waħda ta ’ Preotact f’ jum wieħed, ikkuntattja lit- tabib jew lill - ispiżjar tiegħek.
If you forget to use Preotact:
Jekk tinsa tuża Preotact:
If you forget to take Preotact (or cannot take Preotact at your usual time), take it as soon as possible on that day.
Jekk tinsa tieħu Preotact (jew ma tistax tieħu Preotact fil- ħin tas- soltu tiegħek), ħudu mill- aktar fis possibbli f’ dik il- ġurnata.
Never take more than one injection in the same day.
Qatt m’ għandek tieħu aktar minn doża waħda fl- istess ġurnata.
If you stop taking Preotact:
Jekk tieqaf tieħu Preotact:
If you stop taking Preotact before finishing the treatment please inform you doctor.
Jekk tieqaf tieħu Preotact qabel it- tmiem tal- kura, jekk jogħġbok għid lit- tabib tiegħek.
Like all medicines, Preotact can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Preotact jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most common side effects (in more than 10% of patients) are: increased level of calcium in the blood, increased level of calcium in the urine, and nausea.
L- aktar effetti sekondarji komuni (f’ aktar minn 10% tal- pazjenti) huma: livell ogħla ta ’ kalċju fid - demm, livell ogħla ta ’ kalċju fl- awrina, u dardir.
Common side effects (in 1 to 10% of patients) are: back pain, constipation, decreased muscle strength, diarrhoea, dizziness, erythema at injection site, fast or irregular heart beats, headache, muscle cramps, pain in extremity, stomach upset, tiredness, and vomiting.
Effetti sekondarji komuni (minn 1 sa 10% tal- pazjenti) huma: uġigħ fid- dahar, stitikezza, saħħa anqas fil- muskoli, dijarea, sturdament, eritema fil- post ta ’ l- injezzjoni, taħbit tal- qalb mgħaġġel jew irregolari, uġigħ ta ’ ras, bugħawwieġ fil- muskoli, uġigħ fl- estremità, taqlib fl- istonku, għeja, u rimettar.
Uncommon side effects (in 0.1% to 1% of patients) are: abdominal pain, flu, increased level of uric acid in the blood, irritation of the skin at the injection site, loss of appetite, smell disturbance, and taste disturbance.
Effetti sekondarji mhux komuni (minn 0. 1% sa 1% tal- pazjenti) huma: uġigħ addominali, żieda fil - livell ta ’ aċidu uriku fid- demm, irritazzjoni tal- ġilda fil- post ta ’ l- injezzjoni, telf ta ’ l- aptit, disturb tax - xamm, u disturb tat- togħma.
HOW TO STORE PREOTACT
KIF TAĦŻEN PREOTACT
Do not use Preotact after the expiry date which is stated on the cartridge after EXP and on the carton after EXP.
23 Tużax Preotact wara d- data ta ’ skadenza li tidher fuq l- iskartoċċ wara JIS u fuq il- kartuna wara JIS.
Unused cartridge
Skartoċċ mhux użat
22 • Do not store above 25°C.
• Taħżinx f’ temperatura ’ l fuq minn 25°C.
Do not freeze. • Keep the cartridges in the outer carton in order to protect them from light
Tagħmlux fil- friża. • Żomm l- iskrataċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Cartridge in use • A cartridge in use (in the Preotact pen) should be stored in a refrigerator (2-8°C).
Skartoċċ waqt l- użu • Skartoċċ waqt l- użu (fil- pinna Preotact) għandu jinħażen fi friġġ (2- 8°C).
Do not freeze. • A cartridge in use will keep for 28 days in refrigerator. • If for some reason you cannot store your Preotact pen (with the inserted cartridge) in a refrigerator for a number of days, it can be stored outside the refrigerator below 25°C - BUT ONLY FOR A TOTAL OF 7 DAYS during the 28-day use period. • If the Preotact solution in the cartridge is more than 28 days old, or if it has not been stored correctly, throw it away, even if the cartridge is not completely empty. • If the Preotact solution becomes cloudy or coloured throw the cartridge away.
Tagħmlux fil- friża. • Skartoċċ waqt l- użu jibqa ’ tajjeb għal 28 ġurnata fi friġġ. • Jekk għal xi raġuni ma tistax taħżen il- pinna Preotact tiegħek (bl- iskartoċċ inserit) fi friġġ għal numru ta ’ ġranet, hija tista ’ tinħażen barra mill- friġġ f’ temperatura taħt 25°C - IŻDA GĦAL TOTAL BISS TA ’ 7 IJIEM matul il- perjodu ta ’ użu ta ’ 28 ġurnata. • Jekk is- soluzzjoni ta ’ Preotact fl- iskartoċċ ikollha aktar minn 28 ġurnata, jew jekk ma tkunx inħażnet sewwa, armiha, anki jekk l- iskartoċċ ma jkunx vojt għal kollox. • Jekk is- soluzzjoni ta ’ Preotact tiddardar jew tieħu l- kulur, armi l- iskartoċċ.
What Preotact contains
X’ fih Preotact
Preotact is supplied in a dual-chamber cartridge.
Preotact jiġi fornut fi skartoċċ ta ’ żewġ kompartimenti.
The first chamber contains the powder with the active substance and the second chamber contains the solvent.
L- ewwel kompartiment fih it- trab bis- sustanza attiva u t- tieni kompartiment fih is- solvent.
• The active substance is parathyroid hormone.
• Is- sustanza attiva hija l- ormon tal- paratirojde.
Each cartridge contains 1.61 mg parathyroid hormone.
Kull skartoċċ fih 1. 61 mg ta ’ ormon tal - paratirojde.
When the powder and the solvent have been mixed, the solution for injection contains parathyroid hormone at a concentration of 1.4 mg/ml.
Meta t- trab u s- solvent jitħalltu, is- soluzzjoni għall- injezzjoni jkun fiha ormon tal - paratirojde f’ konċentrazzjoni ta ’ 1. 4 mg/ ml.
• Other ingredients:
• Sustanzi oħra:
The powder contains sodium chloride 0.4%, mannitol, citric acid monohydrate, hydrochloric acid, and sodium hydroxide.
It- trab fih sodium chloride 0. 4%, mannitol, citric acid monohydrate, hydrochloric acid, u sodium hydroxide.
The solvent contains metacresol and water for injections.
Is- solvent fih metacresol u ilma għall- injezzjonijiet.
What Preotact looks like and contents of the pack
Id- dehra ta ’ Preotact u l- kontenuti tal- pakkett
Preotact is a powder and solvent for solution for injection.
Preotact huwa trab u solvent għal soluzzjoni għall- injezzjoni.
It is supplied in a dual-chamber cartridge which contains 1.61 mg parathyroid hormone as powder and 1.13 ml of solvent
Jiġi fi skartoċċ ta ’ żewġ kompartimenti li fih 1. 61 mg ta ’ ormon tal- paratirojde bħala trab u 1. 13 ml ta ’ solvent.
Preotact is available in packs of 2 and 6 cartridges.
Preotact jiġi f’ pakketti ta ’ 2 u 6 skrataċ.
23 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
24 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
България Nycomed Langebjerg 1 DK-4000 Roskilde Дания Tel: +45 46 77 11 11 info@nycomed.com
België/ Belgique/ Belgien Nycomed Belgium SCA/ CVA Gentsesteenweg 615 B- 1080 Bruxelles / Brussel / Brüssel Tél/ Tel: +32 2 464 06 11 nycomed- belgium@ nycomed. com България Nycomed Langebjerg 1 DK- 4000 Roskilde Дания Tel: +45 46 77 11 11 info@ nycomed. com
24 España Nycomed Pharma, S.A C/ Alsasua 20 28023 – Madrid Tlf: +34 917 14 99 00
25 España Nycomed Pharma, S. A C / Alsasua 20 28023 – Madrid Tlf: +34 917 14 99 00
26
26 Dan il- fuljett kien approvat l- aħħar f’ XX/ SSSS
What is Prepandrix?
X’ inhu Prepandrix?
Prepandrix is a vaccine that is given by injection.
Prepandrix huwa vaċċin li jingħata b’ injezzjoni.
Prepandrix contains a flu strain called ‘ A/ VietNam/ 1194/ 2005 NIBRG-14’ (H5N1).
Prepandrix fiha r- razza ta ’ l- influwenza msejħa ‘ A/ Viet Nam/ 1194/ 2005 NIBRG- 14 ’ (H5N1).
What is Prepandrix used for?
Għal xiex jintuża Prepandrix?
Prepandrix is a vaccine for use in adults aged between 18 and 60 years to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Prepandrix huwa vaċċin għall- użu f’ adulti ta ’ etajiet bejn it- 18 u s- 60 sena għal protezzjoni kontra l - influwenza kkawżata mir- razza H5N1 (tip) ta ’ vajrus ta ’ l- influwenza tat- tip A.
Prepandrix is given according to official recommendations.
Prepandrix jiġi mogħti skond ir- rakkommandazzjonijiet uffiċjali.
How is Prepandrix used?
Kif jintuża Prepandrix?
Prepandrix is given by injection into the upper arm muscle in two doses, at least three weeks apart.
Prepandrix jingħata b’ injezzjoni fil- muskolu tal- parti ta ’ fuq tad- driegħ f’ żewġ dożi, mill- anqas bi tliet ġimgħat bejniethom.
How does Prepandrix work?
Kif jaħdem Prepandrix?
Prepandrix is a ‘ prepandemic’ vaccine.
Prepandrix huwa vaċċin ‘ prepandemiku ’.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it.
Influwenza pandemika sseħħ meta joħroġ tip ta ’ vajrus ġdid (razza) tal- vajrus ta ’ l- influwenza li jista ’ jinfirex faċilment minn persuna għal oħra peress li n- nies ma jkollom l- ebda immunità (protezzjoni) kontra tiegħu.
Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
Esperti tas- saħħa huma konċernati li l- influwenza pandemika li jmiss tista ’ tiġi kkawwżata minn dan it- tip ta ’ H4N1 tal- vajrus.
Prepandrix has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.
Prepandrix ġie żviluppat sabiex jipprovdi protezzjoni kontra dan it- tip, sabiex ikun jista ’ jintuża qabel jew matul il- pandemija ta ’ l- influwenza.
Prepandrix contains small amounts of haemagglutinins (proteins from the surface) of the H5N1 virus.
Prepandrix fih ammonti żgħar ta ’ emoglutinins (proteini mill- wiċċ) ta ’ vajrus imsemmi H5N1.
How has Prepandrix been studied?
Kif ġie studjat INVIRASE?
The effects of Prepandrix were first tested in experimental models before being studied in humans.
L- effetti ta ’ Prepandrix għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The main study of Prepandrix included 400 healthy adults and compared the ability of different doses of Prepandrix, with or without the adjuvant, to trigger the production of antibodies (‘ immunogenicity’).
L- istudju prinċipali ta ’ Prepandrix inkluda 400 adult b’ saħħithom u kumparat mal- kapaċità ta ’ dożi differenti ta ’ Pandemrix, b’ adjuvant jew mingħajru, jqanqal il- produzzjoni ta ’ antikorpi (‘ immunoġeniċiti ’).
The participants received two injections of Prepandrix containing one of four different doses of haemagglutinin.
Il- parteċipanti rċevew żewġ injezzjonijiet ta ’ Prepandrix li fihom doża waħda minn erba ’ differenti ta ’ emoglutinins.
What benefit has Prepandrix shown during the studies?
X' benefiċċju wera Prepandrix matul l- istudji mwettqa?
The main study showed that Prepandrix containing 3.75 micrograms of haemagglutinin and the adjuvant produced an antibody response that met these criteria.
L- istudju prinċipali wera li Prepandrix fih 3. 75 mikrogrammi ta ’ emoglutinins u l- adjuvant ipproduċa reazzjoni b’ antikorp li ssodisfa dawn il- kriterji.
What is the risk associated with Prepandrix?
X’ inhu r- riskju assoċjat ma ’ Prepandrix?
The most common side effects with Prepandrix (occurred with 1 in 10 doses or more of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
L- aktar effetti sekondarji ta ’ Prepandrix (ġraw f’ doża waħda minn għaxra jew aktar tal- vaċċin) huma uġiegħ ta ’ ras, artralġja (uġiegħ fil- ġogi), majalġja (uġiegħ fil- ġogi), reazzjonijiet fis- sit ta ’ l- injezzjoni (ebusija, nefħa, uġiegħ u ħmura), deni u għejja (ħeddla).
For the full list of all side effects reported with Prepandrix, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtata b’ Prepandrix, ara l- Fuljett ta ’ Tagħrif.
Prepandrix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Prepandrix m’ għandux jingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill- komponenti tal- vaċċin, jew għal kwalunkwe sustanza li tinsab f’ livelli ta ’ traċċi, bħal bajd, proteina tat- tiġieġ, ovalbumin (proteina fl- abjad tal- bajd), formaldehyde, gentamicin sulphate (antibijotiku) u sodium deoxycholate..
Vaccination with Prepandrix should be delayed in people who have a sudden fever.
Il- vaċċin tal- Prepandrix għandu jiġi mogħti aktar tard lil persuni li jaqbadhom deni f’ daqqa.
Why has Prepandrix been approved?
Għaliex ġie approvat Prepandrix?
The CHMP decided that Prepandrix’ s benefits are greater than its risks for active immunisation against H5N1 subtype of influenza A virus.
Is- CHMP ddeċieda li l- benefiċċji ta ’ Prepandrix huma aktar mir- riskji tiegħu għal immunizzazzjoni attiva kontra l- H5N1 ta ’ influwenza tal- vajrus tip A.
The Committee recommended that Prepandrix be given marketing authorisation.
Il- Kumitat irrakkomanda li Prepandrix jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Prepandrix:
Tagħrif ieħor dwar Prepandrix:
The European Commission granted a marketing authorisation valid throughout the European Union for Prepandrix to GlaxoSmithKline Biologicals s. a. on 14 May 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Prepandrix, valida fl- Unjoni Ewropea kollha, lil GlaxoSmithKline Biologicals s. a. fil - 14 Mejju 2008.
The full EPAR for Prepandrix can be found here.
L- EPAR sħiħ għal Prepandrix jista ’ jiġi kkonsultat hawn.
Suspension and Emulsion for
Suspensjoni u Emulsjoni għal emulsjoni għall -
suspension (H5N1): vial (glass)
suspensjoni (H5N1): kunjett (ħġieġ) emulsjoni (suppliment):
50 vials (suspension)
50 kunjett (suspensjoni) 2 x 25 kunjett
emulsion for injection
injezzjoni
2.5 ml (emulsion)
kunjett (ħġieġ)
2 x 25 vials (emulsion)
(emulsjoni)
Prepandrix suspension and emulsion for emulsion for injection.
Prepandrix suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni.
Prepandrix should be used in accordance with official guidance.
Prepandrix għandu jintuża skond gwida uffiċjali.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues ((egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Għandha tingħata attenzjoni meta l- vaċċin jingħata lil persuni b’ sensittivita` eċċessiva magħrufa (għajr reazzjoni anafilattika) għas- sustanza attiva, għal xi wieħed mis- sustanzi mhux attivi, għal thiomersal u għar- residwi (proteina tal- bajd u tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate).
Prepandrix should under no circumstances be administered intravascularly or intradermally.
Prepandrix m’ għandu qatt jingħata b’ mod intravaskulari jew ġol- ġilda.
No data have been generated in pregnant women with Prepandrix or with any other vaccine that contains the AS03 adjuvant.
Ma ħarġet l- ebda dejta f’ nisa tqal dwar Prepandrix jew dwar kwalunkwe vaċċin ieħor li fih is - suppliment AS03.
Healthcare providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
3 involuti meta jagħtu l- vaċċin lil nisa tqal waqt li jikkunsidraw ir- rakkomandazzjonijiet uffiċjali.
There are no data regarding the use of Prepandrix during lactation.
M’ hemm l- ebda dejta dwar l- użu ta ’ Prepandrix waqt it- treddigħ.
The potential benefits to the mother and risks to the infant should be considered before administering Prepandrix during lactation.
Il- benefiċċji li jista ’ jkun hemm għall- omm u r- riskji għat- tarbija għandhom jiġu kkunsidrati qabel jingħata Prepandrix waqt it - treddigħ.
No post-marketing surveillance data are available following Prepandrix administration.
L- ebda dejta ta ’ sorveljanza ta ’ wara t- tqegħid fis- suq m’ hija disponibbli wara li ngħata Prepandrix.
4 Generalised skin reactions including urticaria
Reazzjonijiet ġenerali fil- ġilda inkluż urtikarja
Immune response against vaccine strain contained in Prepandrix:
Respons immuni kontra r- razza tal- vaċċin li hemm f’ Prepandrix:
In a consistency study, more than 900 subjects aged 18-60 years received Prepandrix following a 0, 21 days schedule.
Fi studju ta ’ konsistenza, aktar minn 900 individwu li għandhom età bejn it- 18- 60 sena rċievew Prepandrix fejn segwew skeda ta ’ 0, 21 ġurnata.
In a dose finding study in subjects aged 18-60 years, 50 subjects received a dose of 3.75 micrograms HA/ AS03 in a volume of 1 ml at 0 and 21 days.
5 Fi studju biex tinstab id- doża, f’ individwi ta ’ età bejn it- 18- 60 sena, 50 individwu rċieva doża ta ’ 3. 75 mikrogrammi HA/ AS03 f’ volum ta ’ 1 ml fil- ġranet 0 u 21.
Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
Antikorp anti- HA Rata ta ’ seroprotezzjoni * † Rata ta ’ serokonverżjoni † Fattur ta ’ serokonverżjoni † * anti- HA ≥1: 40
82% 27.9
Jum 42 84% 82% 27. 9
52% 4.4
Jum 180 54% 52% 4. 4
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
† rata ta ’ seroprotezzjoni: proporzjon ta ’ individwi b’ titre ta ’ inibizzjoni ta ’ l- emagglutinizazzjoni (HI) ≥ 1: 40; rata ta ’ serokonverżjoni: proporzjon ta ’ individwi li jew kienu seronegattivi qabel it- tilqim u għandhom titre protettiv ta ’ ≥ 1: 40 wara t- tilqim, jew kienu seropożittivi qabel it- tilqim u għandhom żieda ta ’ 4 darbiet fit- titre; fattur ta ’ serokonverżjoni: proporzjon tal- medja tat- titre ġeometriku GMT wara t- tilqim u GMT qabel it- tilqim.
Twenty one days after the second dose, a 4-fold increase in serum neutralising antibody titres was obtained in 77.1% of subjects against the A/ Indonesia/ 5/ 2005 strain, in 75.0% of subjects against A/ Anhui/ 01/ 2005 and in 85.0% of subjects against A/ Turkey/ Turkey/ 1/ 2005.
6 Wieħed u għoxrin ġurnata wara t- tieni doża, żieda ta ’ 4 darbiet aktar fit- titres ta ’ l- antikorp li jinnewtralizza s- serum inkiseb f’ 77. 1% ta ’ l- individwi kontra r- razza A/ Indonesia/ 5/ 2005, f’ 75. 0% ta ’ l- individwi kontra A/ Anhui/ 01/ 2005 u f’ 85. 0% ta ’ l- individwi kontra A/ Turkey/ Turkey/ 1/ 2005.
6 In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG-14).
F’ kull esperiment erba ’ gruppi ta ’ 6 inmsa kienu mlaqqma fil- muskolu b’ vaċċin supplimentat b’ AS03 li kien fih HA li tnisslet minn H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG- 14).
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4)
7 After mixing, the vaccine should be used within 24 hours.
Wara li jitħallat il- vaċċin irid jintuża fi żmien 24 siegħa.
Prepandrix consists of two containers:
Prepandrix jikkonsisti f’ żewġ kontenituri:
The volume of Prepandrix (5 ml) after mixing corresponds to 10 doses of vaccine.
Il- volum ta ’ Prepandrix (5 ml) wara li jitħallat jikkorisspondi għal 10 dożi ta ’ vaċċin.
Any unused product or waste material should be disposed of in accordance with local requirements.
8 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version V01 (dated June 2006) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni V01 (bid- data ta ’ Ġunju 2006) ppreżentata fit- Taqsima 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda f’ postha u tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv3 (dated 31 January 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġjar tar- Riskju L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza l- oħra dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni RMPv03 (bid- data ta ’ 31 ta ’ Jannar 2008) tal- Pjan ta ’ l- Immaniġġjar tar- Riskju (RMP) ppreżentata fit- Taqsima 1. 8. 2. ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ xi aġġornamenti sussegwenti oħra ta ’ l- RMP miftehmin mas- CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, RMP aġġornat għandu jkun sottomess • Meta tkun irċevuta informazzjoni ġdida li tistà tagħmel impatt fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskju. • Fi żmien 60 ġurnata minn meta tkun intlaħqet mira importanti (farmakoviġilanza jew tnaqqis ta ’ riskju)
11 PSURs
11 • Fuq talba ta ’ l- EMEA
PSUR submission when Prepandrix is used during the influenza pandemic:
Sottomissjoni ta ’ PSUR meta Prepandrix tintuża waqt influwenza pandemika:
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 (if the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
Sommarju qasir għandu jingħata wkoll mar- rapporti perjodikament aġġornati dwar sigurta`, li fihom kull parti ta ’ tħassib għandha tkun enfasizzata, ix- xogħol ta’ evalwazzjoni tas- sinjali jingħata prijorita` (jekk il- każ ikun ta ’ ħafna sinjali) u ħinijiet xierqa għandhom jingħataw għall - għoti ta ’ rapport sħiħ dwar l- evalwazzjoni ta ’ sinjali.
All 12 signal evaluation reports should be provided, including those that were subsequently not identified as being signals.
Ir- rapporti kollha dwar l- evalwazzjoni ta ’ sinjali għandhom jingħataw, inklużi dawk li sussegwentement ma kienux identifikati bħala sinjali.
Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandrix suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat)
16 Intramuscular use Shake before use Read the package leaflet before use
Użu għal ġol- muskolu Ħawwad qabel l- użu Aqra l- fuljett ta ’ tagħrif qabel l- użu
Prepandrix suspension for emulsion for injection Prepandemic influenza vaccine (H5N1)
Prepandrix suspensjoni għal emulsjoni għall- injezzjoni Vaċċin għal influwenza prepandemika (H5N1)
Suspension to be exclusively mixed with emulsion before administration 19 8.
Suspensjoni li għandha titħallat esklussivament ma ’ emulsjoni qabel tingħata
Emulsion for emulsion for injection for Prepandrix
Emulsjoni għal emulsjoni għall- injezzjoni għal Prepandrix
Vial A Prepandrix suspension for emulsion for injection IM
Kunjett A Prepandrix suspensjoni għal emulsjoni għall- injezzjoni IM
Vial B Emulsion for emulsion for injection for Prepandrix
Kunjett B Emulsjoni għal emulsjoni għall- injezzjoni għal Prepandrix
Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandrix suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni Vaċċin ta ’ l- influwanza prepandemika (H5N1) (virjon maqsum, inattivat, supplimentat)
What Prepandrix is and what it is used for 2.
X’ inhu Prepandrix u għalxiex jintuża 2.
Before you receive Prepandrix 3.
Qabel ma tieħu Prepandrix 3.
How Prepandrix is given 4.
Kif għandek tieħu Prepandrix 4.
How to store Prepandrix 6.
Kif taħżen Prepandrix 6.
WHAT PREPANDRIX IS AND WHAT IT IS USED FOR
X’ INHU PREPANDRIX U GĦALXIEX JINTUŻA
Prepandrix is a vaccine for use in adults from 18 to 60 years old.
Prepandrix huwa vaċċin għall- użu fl- adulti ta ’ età minn 18 sa 60 sena.
It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
L- intenzjoni hija li jingħata qabel jew waqt il- pandemija ta 'l- influwenza li jmiss biex jilqa ’ kontra l- influwenza kkawżata mit- tip H5N1 tal- virus.
As with all vaccines, Prepandrix may not fully protect all persons who are vaccinated.
Bħal vaċċini l- oħra kollha, Prepandrix jista ’ ma jipproteġix kompletament lill- persuni kollha li jkunu mlaqqma.
BEFORE YOU RECEIVE PREPANDRIX
QABEL MA TIEĦU PREPANDRIX
Prepandrix should not be given:
Tieħux Prepandrix:
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandrix (these are listed at the end of this leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
• jekk xi darba kellek reazzjoni allerġika f’ daqqa waħda li tkun ta ’ periklu għal- ħajja għal kwalunkwe ingredjent ta ’ Prepandrix (dawn huma mniżżla fl- aħħar ta ’ dan il- fuljett), jew għal xi wieħed mis- sustanzi li jista ’ jkun fih f’ ammonti żgħar ħafna: proteini tal- bajd jew tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate (antibiotiku) jew sodium deoxycholate.
A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandrix.
Infezzjoni ħafifa bħal riħ m’ għandiex tkun problema, iżda t- tabib tiegħek jagħtik parir jekk inti tistax xorta waħda titlaqqam bi Prepandrix.
26 formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
26 Oqgħod attent ħafna bi Prepandrix:
In the first few weeks after vaccination with Prepandrix the results of these tests may not be correct.
Fl - ewwel ftit ġimgħat wara t- tilqim bi Prepandrix, ir- riżultati ta ’ dawn it- testijiet jistgħu ma jkunux tajba.
Tell the doctor requesting these tests that you have recently received Prepandrix.
Għid lit- tabib li qed jordnalek dawn it- testijiet li m’ ilekx li ħadt Prepandrix.
There are no data on the use of Prepandrix given at the same time as other vaccines.
M’ hemmx tagħrif dwar l- użu ta ’ Prepandrix meta jingħata flimkien ma ’ vaċċini oħrajn.
Therefore, Prepandrix is not intended to be given at the same time as other vaccines.
Għalhekk, Prepandrix m’ huwiex intenzjonat li jingħata fl- istess ħin ma ’ vaċċini oħra.
However, if this cannot be avoided, the other vaccine will be injected into the other arm.
Madankollu, jekk dan ma jistax jiġi evitat, il- vaċċin l- ieħor għandu jiġu injettati fid- driegħ l- ieħor.
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandrix can still be given but your response to the vaccine may be poor.
Jekk tieħu xi mediċini li jnaqqsu l- immunita` għall- infezzjonijiet jew jekk tkun tieħu xi tip ta ’ kura oħra (bħal radjoterapija) li taffettwa s- sistema immuni, Prepandrix xorta jista ’ jingħata iżda r- respos tiegħek għall- vaċċin jista ’ jkun batut.
Pregnancy and breast-feeding There is no information on the use of Prepandrix in pregnant or breast-feeding women.
Tqala u Treddigħ M’ hemmx informazzjoni dwar l- użu ta ’ Prepandrix f’ nisa tqal jew li qed ireddgħu.
Important information about some of the ingredients of Prepandrix Thiomersal (preservative) is present in this product, and it is possible that you may experience an allergic reaction.
Tagħrif importanti dwar xi wħud mill- ingredjenti ta ’ Prepandrix Thiomersal (preservattiv) huwa preżenti f’ dan il- prodott, u huwa possibbli li inti jista ’ jkollok reazzjoni allerġika.
HOW PREPANDRIX IS GIVEN
KIF GHANDEK TIEHU PREPANDRIX
You will receive two doses of Prepandrix.
Inti se tirċievi żewġ dożi ta ’ Prepandrix.
The doctor or nurse will give Prepandrix as an injection into your upper arm muscle.
It- tabib jew l- infermier jagħti Prepandrix bħala injezzjoni fil- muskolu tan- naħa ta ’ fuq tad- driegħ.
• • • • •
Bħal kull mediċina oħra, Prepandrix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tiredness Headache Pain, redness, swelling or a hard lump at the injection site Fever Aching muscles, joint pain
♦ Komuni ħafna (dawn jistgħu jseħħu b’ doża 1 minn kull 10 dożi jew aktar tal- vaċċin): • Għeja • Uġigħ ta ’ ras • Uġigħ, ħmura, nefħa jew għoqda iebsa fis- sit ta ’ l- injezzjoni • Deni • Uġigħ fil- muskoli, uġigħ fil- ġogi
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives)
♦ Mhux komuni (dawn jistgħu jseħħu b’ sa doża 1 minn kull 100 doża tal- vaċċin): • Reazzjonijiet mifruxa fil- ġilda li jinkludu l- urtikarja (ħorriqija)
♦ Rare (these may occur with up to 1 in 1,000 doses of the vaccine): • Severe stabbing or throbbing pain along one or more nerves • Fits • Low blood platelet count which can result in bleeding or bruising • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death
♦ Rari (dawn jistgħu jseħħu f’ sa doża 1 minn kull 1, 000 doża tal- vaċċin): • Uġigħ qawwi donnu kkawżat minn xi arma bil- ponta jew tektik matul nerv wieħed jew aktar • Aċċessjonijiet • Għadd baxx ta ’ plejtlits fid- demm li jista ’ jwassal għal fsada jew tbenġil • Reazzjonijiet allerġiċi li jwasslu għal waqa ’ perikoluża fil- pressjoni, li jekk ma tiġix ikkurata tista ’ twassal għall- kollass, koma u mewt
HOW TO STORE PREPANDRIX
KIF TAHZEN PREPANDRIX
Before the vaccine is mixed:
28 Qabel ma jitħallat il- vaċċin:
28 After the vaccine is mixed:
Wara li jitħallat il- vaċċin:
What Prepandrix contains
X’ fih Prepandrix
The emulsion vial contains an ‘adjuvant’ (AS03).
Il- kunjett ta ’ l- emulsjoni fih ‘ suppliment ’ (AS03).
This compound contains squalene (10.68 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams).
Dan il- kompost fih squalene (10. 68 milligrammi), DL- α- tocopherol (11. 86 milligrammi) u polysorbate 80 (4. 85 milligrammi).
Adjuvants are used to improve the body’s response to the vaccine.
Is - supplimenti jintużaw biex itejbu r- respons tal- ġisem għal vaċċin.
What Prepandrix looks like and contents of the pack
Id- dehra ta ’ Prepandrix u l- kontenuti tal- pakkett
One pack of Prepandrix consists of:
Pakkett wieħed ta ’ Prepandrix fih:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
29 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżenttant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
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 Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu / ---------------------------------------------------------------------------------------------------------------------
Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Qabel ma tħallat iż- żewġ komponenti, l- emulsjoni u s- suspensjoni għandhom jitħallew jilħqu t - temperatura tal- kamra, jitħawwdu, u jiġu spezzjonati viżwalment għal xi frak u/ jew dehra fiżika mhux normali.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif
31
31 jitolbu l- liġijiet lokali.
What is Prevenar?
X' inhu Prevenar?
Prevenar is a vaccine.
Prevenar huwa vaċċin.
It is a suspension for injection that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae).
Huwa sospensjoni għall- injezzjoni li fiha partijiet purifikati tal- kapsula ta 'barra tal- batterju Streptococcus pneumoniae (S. pneumoniae).
These include sepsis (blood infection), meningitis (infection of the membranes that surround the brain and spine), pneumonia (infection of the lungs), otitis media (infection of the middle ear) and bacteraemia (bacteria detected in the blood).
Għal xiex jintuża Prevenar Prevenar jintuża fit- tilqim ta 'tfal żgħar (infants) u tfal f' età bejn xahrejn u ħames snin kontra mard ikkawżat minn S. pneumoniae, fosthom sepsi (infezzjoni fid- demm), meninġite (infezzjoni fil - membrani li jdawru l- moħħ u s- sinsla tad- dahar), pulmonite (infezzjoni fil- pulmun), otite medja (infezzjoni fil- widna tan- nofs) u batterjemija (bacteraemia, batterji li jinsabu fid- demm).
How is Prevenar used?
Kif jintuża Prevenar?
The vaccination schedule to be used depends on the age of the child and should be based on official recommendations. • Infants aged between two and six months need three doses.
Il- programm ta 'tilqim li għandu jintuża jiddependi mill- età tat- tifel jew tifla u għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali: • tfal żgħar f' età bejn xahrejn u sitt xhur ikollhom bżonn tliet dożi.
The first dose is usually given at two months of age with an interval of at least one month between doses.
L- ewwel doża ġeneralment tingħata f' età ta 'xahrejn u jitħalla minn ta' l- inqas xahar bejn doża u oħra.
A fourth dose (booster) is recommended in the second year of life.
Ir- raba 'doża (booster) hi rakkomandata bejn età ta' sena u sentejn.
Alternatively, when Prevenar is given as part of a ‘ universal infant immunisation programme’ (when all infants in an area are vaccinated at around the same time), two doses can be given with an interval of at least two months, followed by a booster at 11 to 15 months of age. • Infants aged between seven and 11 months need two doses, with an interval of at least one month between doses.
Inkella, meta Pevenar jingħata bħala parti minn programm ta 'immunizzazzjoni infantili universali (tilqim kollettiv u kważi simultanju tat- tfal żgħar kollha li jinsabu f' żona partikolari) jistgħu jingħataw żewġ dożi u jitħallew ta' l- inqas xahrejn, u mbagħad booster bejn 11 u 15- il xahar ta 'età; • tfal żgħar f' età bejn sebgħa u 11- il xahar ikunu jeħtieġu żewġ dożi, b' mill- inqas xahar bejn doża u oħra.
A third dose is recommended in the second year of life. • Children aged between 12 and 23 months need two doses, with an interval of at least two months between doses. • Children aged between 24 months and five years need one single dose.
It- tielet doża hi rakkomandata bejn età ta 'sena u sentejn. • tfal f' età bejn 12 u 23 xahar ikunu jeħtieġu żewġ dożi, u jitħallew b' mill- inqas xahrejn bejn doża u oħra. • tfal ta' bejn 24 xahar u ħames snin ikunu jeħtieġu doża waħda.
The vaccine is given by injection into the thigh muscle in infants, or into the upper arm muscle in young children.
Il- vaċċin għandu jingħata lit- tfal żgħar b' injezzjoni fil- muskolu fil- koxxa jew fil- muskolu tan- naħa ta 'fuq tad- driegħ (muskolu deltojde) tat- tfal iż- żgħar.
How does Prevenar work?
Kif jaħdem Prevenar?
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi 'jgħallmu' lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tiddefendi lilha nnifisha kontra l- mard.
When a person is given the vaccine, the immune system recognises the bacterium contained in the vaccine as ‘ foreign’ and makes antibodies against it.
Meta persuna tingħata vaċċin, is- sistema immunitarja tagħraf il- batterju li jkun jinsab fil- vaċċin bħala 'barrani' u tipproduċi antikorpi kontrieh.
The immune system will then be 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Is- sistema immunitarja mbagħad 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. able to produce antibodies more quickly when it is exposed to the bacterium again.
Reproduction is authorised provided the source is acknowledged. tkun tista 'tipproduċi antikorpi iktar malajr meta tkun esposta għall- batterju mill- ġdid.
This helps to protect against the disease.
Dan jgħin fil - protezzjoni kontra l- marda.
Prevenar contains small amounts of polysaccharides (a type of sugar) extracted from the ‘ capsule ’ that surrounds the S. pneumoniae bacterium.
Prevenar fih ammonti żgħar ta 'polisakkaridi (tip ta' zokkor) estratti mill - 'kapsula' li ddawwar il - batterju S. pneumonia.
These polysaccharides have been purified, then ‘ conjugated’ (attached) to a carrier to help them be better recognised by the immune system.
Dawn il- polisakkaridi jkunu ġew ippurifikati, imbagħad imwaħħla ma 'sustanza li ġġorrhom biex ikunu jistgħu jintgħarfu aħjar mis- sistema immunitarja.
The vaccine is also ‘ adsorbed’ (fixed) onto an aluminium compound to stimulate a better response.
Il- vaċċin huwa wkoll 'assorbit' (jeħel) f' kompost ta 'l- aluminju biex jistimula rispons aħjar.
Prevenar contains the polysaccharides from different types of S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F).
Prevenar ikun fih il- polisakkaridi minn tipi differenti ta 'S. pneumoniae (serotipi 4, 6B, 9V, 14, 18C, 19F u 23F).
In Europe, it is estimated that these are responsible for about 54% to 84% of invasive infections (infections that have spread into the body) in infants and children under the age of two years, and for about 62% to 83% of invasive infections in children aged between two and five years.
Fl- Ewropa, hu stmat li dawn huma responsabbli għal madwar 54% sa 84% ta 'l - infezzjonijiet invażivi (infezzjonijiet li jinxterdu mal- ġisem) fit- tfal żgħar u tfal ta' taħt l- età ta 'sentejn, u għal madwar 62% sa 83% ta' l- infezzjonijiet invażivi fit- tfal li jkollhom bejn sentejn u ħames snin.
How has Prevenar been studied?
Kif ġie studjat Prevenar?
The effectiveness of Prevenar in the prevention of S. pneumoniae invasive disease has been studied in almost 38,000 infants.
L- effikaċja ta 'Prevenar fil- prevenzjoni tal- marda invażiva ta' S. pneumoniae ġew studjati f' madwar 38, 000 tifel u tifla żgħar.
Half of the infants received Prevenar, and the remainder received another vaccine that is not active against S. pneumoniae.
Nofs dawn it- tfal żgħar ingħata Prevenar u l- bqija ngħataw vaċċin ieħor, li mhuwiex attiv kontra S. pneumoniae.
Prevenar was given at two, four, six and 12 to 15 months of age.
Prevenar ingħata meta t- tfal kellhom età ta 'xahrejn, erba' xhur, sitt xhur u bejn 12 sa 15- il xahar.
The study measured the number of children who developed an S. pneumoniae invasive disease during the 3.5 years of the study.
L- istudju kejjel l- għadd ta 'tfal li kienet qabdithom xi marda invażiva ta' S. pneumoniae matul it- tliet snin u nofs ta 'l- istudju.
Additional studies looked at the effectiveness and safety of Prevenar in older infants and children, and at the development of antibodies in infants after the two-dose immunisation schedule followed by a booster injection.
Studji addizzjonali eżaminaw l- effikaċja u s- sigurtà ta 'Prevenar fit- tfal mhux żgħar ħafna (older infants) u fit- tfal, u l- iżvilupp ta' antikorpi fit- tfal żgħar wara l- programm ta 'immunizzazzjoni b' żewġ dożi segwiti minn injezzjoni booster.