qanastek/EMEA-V3 huggingface dataset:
Infanrix Penta can be given to infants who received a hepatitis B vaccine at birth.
Infanrix Penta jista ’ jingħata lit- trabi jew lit- tfal żgħar li jkunu rċevew il- vaċċin għall- epatite B fit- twelid.
How does Infanrix Penta work?
Kif jaħdem Infanrix Penta?
Infanrix Penta is a vaccine.
Infanrix Penta huwa vaċċin.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Infanrix Penta fih ammonti żgħar ta: • tossojdi mill- batterji li jikkawżaw difterite u tetnu; • tossojdi u proteini oħra ppurifikati minn B pertussis; • antiġenu tas- superfiċje (proteina mis- superfiċje) tal- vajrus tal- epatite B; • poljovajrusis mhux attivati (tat- tipi 1, 2 u 3); Meta t- trabi jew it- tfal ta ’ età żgħira jingħataw il- vaċċin, is- sistema immunitarja tagħraf il- partijiet tal - batterji u l- vajrusis bħala 'barranin' u tipproduċi antikorpi kontrihom.
This helps to protect against the diseases that these bacteria and viruses cause.
Is- sistema immunitarja mbagħad
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. tkun tista 'tipproduċi antikorpi iktar malajr meta tkun esposta mill- ġdid għall- batterji jew il- vajrusis.
The surface antigens of the hepatitis B virus are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
L- antiġeni tas- superfiċje tal- vajrus tal- epatite B huma prodotti minn metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: huwa magħmul minn ħmira li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini.
Infanrix Penta is a combination of components that have been available in the European Union (EU) in other vaccines: diphtheria, tetanus, pertussis and hepatitis B were available in Infanrix HepB from 1997 until 2005, and diphtheria, tetanus, pertussis and polioviruses are available in other vaccines.
Infanrix Penta huwa kumbinazzjoni ta ’ komponenti li ilhom disponibbli fl- Unjoni Ewopea (UE) f’ vaċċini oħra: difterite, tetnu, pertussi u epatite B kienu disponibbli f’ Infanrix HepB mill- 1997 sal - 2005, u d- difterite, it- tetnu, il- pertussi, il- poljovajrusis u l- komponenti Hib jinsabu disponibbli f’ vaċċini oħra.
How has Infanrix Penta been studied?
Kif ġie studjat Infanrix Penta?
Infanrix Penta has been studied in 16 studies looking at the first course of vaccination.
Infanrix Penta ġie ttestjat f’ 16- il studju li eżaminaw l- ewwel kors tal- vaċċin.
The studies involved over 10,000 infants, about three quarters of whom received Infanrix Penta, given according to various time schedules.
L- istudji involvew iktar minn 10, 000 tarbija u tfal żgħar, fejn madwar tliet kwarti minnhom irċevew Infanrix Penta mogħti skont diversi skedi ta ’ ħin.
Infanrix Penta has also been studied in nine studies of booster vaccination involving over 4,000 infants, 714 of whom received Infanrix Penta as a booster.
Infanrix Penta ġie wkoll studjat f’ disa ’ studji ta ’ vaċċin ‘ booster ’ li kienu jinvolvu iktar minn 4, 000 tarbija u tfal żgħar, fejn 714 irċevew Infanrix Penta bħala ‘ booster ’.
The main measure of effectiveness was the production of antibodies against the active substances after vaccination.
Il- kejl ewlieni tal- effikaċja kien il- produzzjoni ta ’ antikorpi kontra s- sustanzi attivi wara li jkun ingħata l - vaċċin.
What benefit has Infanrix Penta shown during the studies?
X’ benefiċċji wera Infanrix Penta waqt l- istudji mwettqa?
The studies showed that a first course of vaccination with Infanrix Penta led to the development of protective levels of antibodies.
L- istudji wrew li l- ewwel kors ta ’ vaċċini b’ Infanrix Penta wassal għall- iżvilupp ta ’ livelli protettivi ta ’ antikorpi.
After one month, between 86 and 100% of the infants had developed protective levels of antibodies against all of the active substances in Infanrix Penta.
Wara xahar, bejn 86 u 100% ta ’ trabi żviluppaw livelli protettivi ta ’ antikorpi kontra s - sustanzi kollha attivi f’ Infanrix Penta.
After booster vaccination, there was an increase in the number of infants with protective levels of antibodies against the active substances.
Wara l- vaċċin ‘ booster ’, kien hemm żieda fin- numru ta ’ trabi b’ livelli protettivi ta ’ antikorpi kontra s - sustanzi attivi.
What is the risk associated with Infanrix Penta?
X’ inhu r- riskju assoċjat ma ’ Infanrix Penta?
The most common side effects with Infanrix Penta (seen in more than 1 in 10 doses of the vaccine) are loss of appetite, fever of 38ºC or more, local swelling, pain and redness at the injection site, fatigue (tiredness), abnormal crying, irritability and restlessness.
L- iktar effetti sekondarji komuni b’ Infanrix Penta (li dehru f’ iktar minn doża waħda minn kull 10 tal - vaċċin) huma t- telf ta ’ aptit, deni ta ’ 38ºC jew iktar, nefħa, uġigħ u ħmura fil- post fejn tingħata t - tilqima, għeja, biki mhux normali, irritabilità u aġitazzjoni.
For the full list of all side effects reported with Infanrix Penta, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtata b’ Infanrix Penta, ara l- Fuljett ta ’ Tagħrif.
Infanrix Penta should not be used in infants who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics), or if the infant has had an allergic reaction after a previous vaccine containing diphtheria, tetanus, pertussis, hepatitis B or polio.
Infanrix Penta m’ għandux jintuża fi trabi jew tfal żgħar li jistgħu jkunu ipersensittivi (allerġiċi) għal kwalunkwe mis- sustanzi attivi, għal kwalunkwe mill- ingredjenti l- oħra tal- vaċċin, jew għal neomiċina u polimissina (antibijotiċi), jew jekk it- tarbija kellha reazzjoni allerġika wara vaċċin li jkun fih difterite, tetnu, pertussi, epatite B jew poljo.
Infanrix Penta should not be given if the infant has had encephalopathy (brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis components.
Infanrix Penta m’ għandux jingħata lil trabi li kellhom enċefalopatija (marda fil- moħħ) li l- kawża tagħha ma tkunx magħrufa fi żmien sebat ijiem ta ’ vaċċin preċedenti b’ vaċċin li fih komponenti ta ’ pertussi.
Infanrix Penta should be postponed in infants with a severe sudden fever.
Infanrix Penta għandu jiġi pospost fi trabi li jkollhom deni qawwi f’ daqqa.
As for all vaccines, if Infanrix Penta is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Bħal ma hu l- każ għall- vaċċini kollha jekk Infanrix Penta jintuża fi trabi tassew prematuri, ikun hemm ir- riskju li t- trabi jesperjenzaw apnea (pawżi qosra fit- teħid tan- nifs).
Their breathing should be monitored for up to three days after vaccination.
In- nifs tagħhom għandu jiġi ssorveljat sa tlett ijiem wara l- vaċċin.
Why has Infanrix Penta been approved?
Għaliex ġie approvat Infanrix Penta?
The Committee for Medicinal Products for Human Use (CHMP) decided that Infanrix Penta’ s benefits are greater than its risks for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Infanrix Penta huma ikbar mir- riskji tiegħu fil- vaċċin primarju u l - ‘ booster ’ fi trabi u tfal żgħar għal kontra d- difterite, t- tetnu, il- pertussi, l- epatite B u l- poljomjelite.
The Committee recommended that Infanrix Penta be given marketing authorisation.
Il- Kumitat irrakkomanda li Infanrix Penta jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Infanrix Penta:
Informazzjoni oħra dwar Infanrix Penta:
The European Commission granted a marketing authorisation valid throughout the EU for Infanrix Penta to GlaxoSmithKline Biologicals s. a. on 23 October 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE kollha għal Infanrix Penta lil GlaxoSmithKline Biologicals s. a. fit- 23 ta ’ Ottubru 2000.
The marketing authorisation was renewed on 23 October 2005.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fit- 23 ta ’ Ottubru 2005.
The full EPAR for Infanrix Penta can be found here.
L- EPAR sħiħ ta ’ Infanrix Penta jista ’ jiġi kkonsultat hawn.
Pre-filled syringe (glass)
Siringa mimlija lesta (ħġieġ)
1 pre-filled syringe
Siringa 1 mimlija lesta
10 pre-filled syringes
10 siringi mimlijin lesti
20 pre-filled syringes
20 siringa mimlija lesta
50 pre-filled syringes
50 siringa mimlija lesta
1 pre-filled syringe (glass) + 1 separate needle
Siringa 1 mimlija lesta (ħġieġ) + labra 1 separata
10 pre-filled syringes + 10 separate needles
10 siringi mimlijin lesti + 10 labar separati
20 pre-filled syringes + 20 separate needles
20 siringa mimlija lesta + 20 labra separata
50 pre-filled syringes + 50 separate needles
50 siringa mimlija lesta + 50 labra separata
pre-filled syringe (glass)
Siringa mimlija lesta (ħġieġ)
1 pre-filled syringe + 2 separate needles
Siringa 1 mimlija lesta + 2 labar separati
pre-filled syringe(glass)
Siringa mimlija lesta (ħġieġ)
10 pre-filled syringes + 20 separate needles
10 siringi mimlijin lesti + 20 labra separata
Diphtheria toxoid, adsorbed Tetanus toxoid, adsorbed Pertussis toxoid, adsorbed Filamentous haemagglutinin, adsorbed Pertactin, adsorbed Recombinant Hepatitis B surface
Toxoid tad- difterite, adsorbit Toxoid tat- tetnu, adsorbit Toxoid tal- pertussis, adsorbit Filamentous haemagglutinin, adsorbit Pertactin, adsorbit Antiġen tas- superfiċje ta ’ l- epatite B (proteina S)
≥ 30IU ≥ 40IU 25 micrograms 25 micrograms 8 micrograms
≥30 IU ≥40 IU 25 mikrogrammi 25 mikrogrammi 8 mikrogrammi
antigen (S protein), adsorbed Inactivated type 1 Poliovirus Inactivated type 2 Poliovirus Inactivated type 3 Poliovirus
manifatturat b’ teknoloġija rekombinanti, adsorbit Poliovirus inattivat tip 1 Poliovirus inattivat tip 2 Poliovirus inattivat tip 3
Infanrix Penta – Suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Infanrix Penta - Suspensjoni għall- injezzjoni Vaċċin (adsorbit) għad- difterite (D), tetnu (T), sogħla konvulsiva (partijiet taċ- ċellula, komponent) (Pa), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV).
1 dose (0.5 ml) contains:
Doża 1 (0. 5 ml) jkun fiha:
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis antigens
Toxoid tad- difterite1 Toxoid tat- tetnu1 Antiġeni tal- Bordatella Pertussis
Pertussis toxoid1 Filamentous Haemagglutinin1 Pertactin1 Hepatitis B surface antigen2,3 Poliovirus (inactivated)
Toxoid tal- Pertussis1 Filamentous Haemagglutinin1 Pertactin1 L- antiġen tas- superfiċje tal- epatite B2, 3 Poliovirus (inattivat)
1
Tip1( tar- razza Mahoney) 4 Tip 2 (tar- razza MEF- 1) 4 Tip 3 (tar- razza Saukett) 4 1
40 D-antigen unit 8 D-antigen unit 32 D-antigen unit
40 unita ’ ta ’ D- antiġen 8 unita ’ ta ’ D- antiġen 32 unita ’ ta ’ D- antiġen
2
adsorbit fuq aluminium hydroxide idradat (Al( OH) 3) 2
adsorbed on aluminium phosphate (AlPO4)
manifatturat fuq ċelloli tal- ħmira (Saccharomyces cerevisiae) b’ teknoloġija rekombinanti tad- DNA 3 adsorbit fuq aluminium phosphate (AlPO4) 4 propogat f’ ċelloli VERO
0.2 milligrams Al
0. 2 milligrammi Al
Suspension for injection Infanrix Penta is a turbid white suspension.
Infanrix Penta hija suspensjoni, bajda u mdardra.
Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Infanrix Penta hija indikata għat- tilqim primarju u tilqim booster ta 'tfal żgħar kontra d- difterite, tetnu, sogħla konvulsiva, epatite B u poljomelite.
Infanrix Penta is not intended for use in children over 36 months of age.
Infanrix Penta mhux addatata għall- użu fi tfal ta ’ fuq is- 36 xahar.
The primary vaccination schedule consists of three doses of 0.5 ml (such as 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) or two doses (such as 3, 5 months).
L- iskeda ta 'tilqim primarju tikkonsisti fit- tlett dożi ta ’ 0. 5ml (bħal 2, 3, 4 xhur; 3, 4, 5 xhur; 2, 4, 6 xhur) jew żewġ dożi (bħal 3, 5 xhur).
There should be an interval of at least 1 month between doses.
Dawn iridu jingħataw b' interval ta 'mill- inqas xahar bejn kull doża.
2 The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.
2 Il- programm fit- tul ta ’ l- iskeda ta ’ l- Immuniżazzjoni (fl- eta ta ’ 6, 10, 14 - il ġimgħa) tista tingħata biss jekk fit- twelid tkun ingħatat doża tal- vaċċin ta ’ l- epatite B.
Locally established immunoprophylactic measures against hepatitis B should be maintained.
Miżuri immunoprofilattiċi kontra l- epatite B stabbiliti lokalment għandhom jibqgħu jiġu osservati.
Where a dose of hepatitis B vaccine is given at birth, Infanrix Penta can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks.
Meta fit- twelid tkun ingħatat doża tal- vaċċin ta ’ l- epatite B, Infanrix penta tista ’ tingħata minflok id - dożi supplementari tal- vaċċin ta 'l- epatite B mill- eta ’ ta ’ sitt ġimgħat - il fuq.
If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Jekk ikun hemm bżonn tat- tieni doża tal- vaċċin ta ’ l- epatite B qabel din l- eta ’, għandu jingħata il- vaċċin ta ’ l- epatite B monovalenti.
3, 5 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose, preferably between 11 and 13 months of age.
3, 5 xhur) ta ’ Infanrix Penta għandha tingħata doża booster almenu 6 xhur wara l- aħħar doża primarja, preferibbilment bejn l- eta ’ ta ’ 11 u 13- il- xahar.
2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose and preferably before 18 months of age.
2, 3, 4 xhur; 3, 4, 5 xhur; 2, 4, 6 xhur) ta ’ Infanrix Penta għandha tinghata doża booster almenu 6 xhur wara l- aħħar doża primarja u preferibbilment qabel l- eta ’ ta 18- il - xahar.
Booster doses should be given in accordance with the official recommendations.
Dożi booster għandhom jingħataw skond ir- rakkomandazzjonijiet uffiċjali.
Infanrix Penta can be considered for the booster if the composition is in accordance with the official recommendations.
Infanrix Penta tista tkun ikkunsidrata għal booster jekk il- kompożizzjoni tkun skond ir - rakkomandazzjonijiet uffiċjali.
Infanrix Penta is for deep intramuscular injection, preferably at alternating sites for subsequent injections.
Infanrix Penta tingħata bħala injezzjoni ġol- muskolu fil- fond, l- aħjar f’ naħiet differenti għall - injezzjonijiet sussegwenti.
Hypersensitivity to the active substances or to any of the excipients or neomycin and polymyxin.
Sensittivita 'eċċessiva għas- sustanzi attivi jew għal xi wieħed mis- sustanzi mhux attivi jew neomycin u polymyxin.
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B or polio vaccines.
Sensittività eċċessiva wara tilqim li jkun ingħata qabel għad- difterite, tetnu, sogħla konvulsiva, epatite B jew polio.
Infanrix Penta is contraindicated if the infant has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Infanrix Penta m' għandiex tingħata jekk it- tifel/ tifla jkun/ tkun għadda/ għaddiet minn esperjenza ta 'xi enċefalopatija ta' etjoloġija mhux magħrufa, li tkun seħħet fi żmien sebat ijiem wara tilqima preċedenti bil- vaċċin tas- sogħla konvulsiva.
In these circumstances pertussis vaccination should be discontinued and the vaccination should be continued with diphtheria-tetanus, hepatitis B and polio vaccines.
F' dawn iċ- ċirkostanzi t- tilqim tas- sogħla konvulsiva għandu jitwaqqaf u l- kors ta 'tilqim għandu jitkompla bil- vaċċini ta' kontra d- difterite- tetnu, l- epatite B u l - polio.
As with other vaccines, administration of Infanrix Penta should be postponed in subjects suffering from acute severe febrile illness.
Bħal fil- każ ta 'tilqim ieħor, it- tilqima ta ’ Infanrix Penta għandha tiġi posposta f' individwi li jkunu qed ibatu minn mard akut ta' deni qawwi.
The presence of a minor infection is not a contraindication.
Il- preżenza ta 'infezzjoni żgħira m’ hiex kontra- indikazzjoni.
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
It- tilqim għandu jsir wara eżami tal- passat mediku (speċjalment dwar xi tilqim ta 'qabel li seta' kellu xi effetti ħżiena) u eżami kliniku.
If any of the following events are known to have occurred in temporal relation to receipt of pertussis- containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:
Jekk hu magħruf li xi wieħed minn dawn l- effetti deher u kien relatat temporanjament mat- teħid ta ’ tilqim tas- sogħla konvulsiva, wieħed għandu jikkonsidra bir- reqqa jekk għandhomx jingħataw dożi oħra tal- vaċċin tas- sogħla konvulsiva.
Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause.
Temperatura ta '≥ 40. 00 C fi żmien 48 siegħa, mhux għal xi kawża oħra magħrufa.
Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination.
Kollass jew stat f' dehra ta 'xokk (episodju ipotoniku- iporesponsiv) fi żmien 48 siegħa mit - tilqima.
Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
3 Biki kontinwu ta ≥ 3 sigħat, fi żmien 48 siegħa mit- tilqima.
Convulsions with or without fever, occurring within 3 days of vaccination.
Aċċessjonijiet bid- deni jew bla deni, fi żmien tlett ijiem mit- tilqima.
3 There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Jista 'jkun hemm ċirkostanzi, bħal inċidenza għolja ta' sogħla konvulsiva, meta l- benefiċċji li wieħed jistenna ikunu akbar mir- riskji possibbli.
As for any vaccination, the risk-benefit of immunising with Infanrix Penta or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
F’ tarbija jew f- tifel/ tifla li qed tbati minn bidu ta ’ xi disturb newroloġiku sever jew li dan id- distub qed ikompli bil- ftit il- ftit, il- benefiċji u r- riskji ta ’ tilqim b’ Infanrix Penta jew li din titħalla għal darb’ oħra għandha tiġi kkunsidrata sewwa, bħal fil- każ ta ’ kull vaċċinazzjoni.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal fil- każ tal- vaċċini kollha li jistgħu jiġu injettati, kura u sorveljanza medika xierqa għandhom dejjem ikunu disponibbli għal xi każ rari anafilattiku li jista 'jinqala' wara t- tilqima.
Infanrix Penta should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Infanrix penta għandha tingħata b' kawtela f’ individwi bi tromboċitopenja jew xi kundizzjoni ta ’ fsada (ħruġ ta ’ demm) għax jista ’ joħroġ d- demm wara li tingħata t- tilqima fil- muskolu lil dawn l- individwi.
Infanrix Penta should under no circumstances be administered intravascularly or intradermally.
Infanrix Penta m' għanda qatt tingħata b' mod intravaskulari jew taħt il- ġilda.
Infanrix Penta will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus or poliovirus.
Infanrix Penta ma tipprevjenix mard ikkawżat minn mikrobi ħlief għal Corynebacterium diphtheriae, Clostridium tetani, Bordatella pertussis, il- vajrus ta 'l- epatite B jew il- vajrus tal- polio.
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Infanrix Penta.
Jekk fil- passat kien hemm xi aċċessjonijiet bid- deni, xi aċċessjonijiet jew Sindromu ta 'Mewt f' Daqqa fit- Tfal (SMDT), fil- passat mediku tal- familja, ma jfissirx li l- użu ta ’ Infanrix Penta huwa kontra - indikat.
Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
Nies imlaqqma, li fil- passat kellhom xi aċċessjonijiet bid- deni, għandhom ikunu osservati mill- qrib għax eventi avversi bħal dawn jistgħu jinqalgħu minn 2 sa 3 ijiem wara t- tilqima.
HIV infection is not considered as a contraindication.
Infezzjoni ta 'HIV m’ hiex meqjusa bħala kontraindikazzjoni.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Ir- rispons immunoloġiku mistenni jista 'ma jinkisibx meta jitlaqqmu pazjenti li huma immunosoppressi.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Clinical studies have demonstrated that Infanrix Penta can be administered simultaneously with Haemophilus influenzae type b vaccines.
Studji kliniċi wrew li Infanrix Penta tista tingħata flimkien mal- vaċċini ta ’ kontra l- Haemophilus influenzae tip b.
In these clinical studies, the injectable vaccines were given at different injection sites.
F’ dawn l- istudji kliniċi, il- vaċċini li jingħataw bħala injezzjoni ġew mgħotija f’ postijiet differenti tal- ġisem.
There are no data with regard to the efficacy and safety of simultaneous administration of Infanrix Penta and Measles-Mumps-Rubella vaccine.
M’ hemmx informazzjoni dwar is- sigurta ’ u l- effikaċja ta ’ Infanrix Penta meta tingħata fl- istess ħin mat- tilqim tal- Ħożba- Gattone- Rubella.
As with other vaccines, it may be expected that in patients receiving immunosuppressive therapy an adequate response may not be achieved.
Bħal fil- każ ta 'vaċċini oħra, wieħed jista' jistenna li f' pazjenti li qiegħdin fuq terapija immunosoppressiva, jista 'ma jinkisibx riżultat sodisfaċenti.
As Infanrix Penta is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Billi Infanrix Penta mhux intenzjonat li jintuża minn adulti, m' hawnx informazzjoni dwar l- użu tal - vaċċin waqt it- tqala jew meta l- omm tkun tredda 'u m’ hemm l- ebda studju adegwat fuq l- effett tal - vaċċin fuq ir- riproduzzjoni ta ’ l- annimali.
Not relevant.
Mhux reżlevanti.
• Clinical trials
• Provi Kliniċi
The safety profile presented below is based on data from more than 10,000 subjects.
Il- profil ta ’ sigurta ’ ippreżentat hawn taħt huwa bbażat fuq data minn aktar minn 10, 000 suġġett.
In virtually all instances, Infanrix Penta was administered at the same time as a Hib vaccine.
Fi kważi kull każ, Infanrix penta ġiet mogħtija flimkien ma ’ vaċċin ta ’ Hib.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix Penta with respect to the primary course.
Bħalma ġie osservat fil- każ ta ’ DTPa u vaċċini kombinati li fihom DTPa, żieda fir- reazzjonijiet lokali u deni ġew irrappurtati wara tilqim booster bl- Infanrix Penta meta mqabbla mal- kors primarju ta ’ tilqim.
- Tabulated summary of adverse reactions (clinical trials):
- Sommarju f’ forma ta ’ tabella tar- reazzjonijiet avversi (provi kliniċi);
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, effetti mhux mixtieqa jidhru f’ ordni ta ’ tnaqqis fis- serjetà tal- każ.
Frequencies per dose are defined as follows:
Il- frekwenzi għal kull doża huma definiti bħala:
(≥ 1/ 10) (≥ 1/ 100 to < 1/ 10) (≥ 1/ 1,000 to < 1/ 100) (≥ 1/ 10,000 to < 1/ 1,000) (< 1/ 10,000)
(≥1/ 10) (≥1/ 100 to < 1/ 10) (≥1/ 1, 000 to < 1/ 100) (≥1/ 10, 000 to < 1/ 1, 000) (< 1/ 10, 000)
Skin and subcutaneous tissue disorders Uncommon: dermatitis, rash Very rare: urticaria
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: dermatite, raxx Rari ħafna: urtikarja
Very common: fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain, redness Common: fever > 39.5°C, local swelling at the injection site (> 50 mm)*, injection site reactions, including induration Uncommon: diffuse swelling of the injected limb, sometimes involving the adjacent joint*
Mhux komuni: nefħa diffusa tas- sieq li fiha ngħatat l- injezzjoni, xi kultant li tinxtered mal- ġog ta ’ ħdeja *
Psychiatric disorders:
5 Disturbi psikjatriċi:
Very common: crying abnormal, irritability, restlessness Uncommon: nervousness
Komuni ħafna: biki mhux normali, irritabilita ’, nuqqas ta ’ sabar Uncommon: nervożita ’
• Post-marketing surveillance
• Tagħrif ta ’ wara t- tqegħid fis- suq
Respiratory, thoracic and mediastinal disorders:
Disturbi fis- sistema nervuża Kollass jew stat bħal ta ’ xokk (episodju ta ’ hypotonic- hyporesponsiveness)
5 Apnoea [see section 4.4 for apnoea in very premature infants (≤ 28 weeks of gestation)]
Disturbi respiratorji, toraċiċi u medjastinali Apnea [ara sezzjoni 4. 4 għal apnea fit- trabi mwieldin ħafna qabel iż- żmien (≤ 28 ġimgħa ta ’ tqala)]
Swelling of the entire injected limb*
Nefħa tas- sieq kollha li fiha ngħatat l- injezzjoni *
Immune system disorders Allergic reactions, including anaphylactic and anaphylactoid reactions
Disturbi fis- sistema immuni Reazzjonijiet allerġiċi, li jinkludu reazzjonijiet anafilattiċi u anafilattodi
In extremely rare cases, paralysis, neuropathy, Guillain-Barré syndrome, encephalopathy, encephalitis and meningitis have been reported.
F’ każijiet rari ħafna ġew irrappurtati paraliżi, newropatija, s- sindromu ta ’ Guillain- Barre, enkefalopatija, enkefalite u meninġite.
Thrombocytopenia has been reported with hepatitis B vaccine.
Ġiet irrappurtata tromboċitopenja bil- vaċċin ta ’ l- epatite B.
* Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines.
* Fi tfal li ngħataw qabel vaċċini kontra s- sogħla konvulsiva aċellulari hemm iżjed ċans li jiżviluppaw reazzjonijiet ta ’ nefħa wara t- tilqim booster meta mqabbla ma ’ tfal li ngħataw qabel vaċċini ta ’ ċellula sħiħa.
These reactions resolve over an average of 4 days.
Dawn ir- reazzjonijiet jgħaddu wara medda ta ’ 4 ijiem.
No case of overdose has been reported.
L- ebda każ ta 'doża eċċessiva ma ġie rappurtat
Bacterial and viral vaccines combined, ATC code J07CA12
Grupp farmako- terapewtiku: vaċċini batterjali u virali flimkien, ATC kodiċi JO7CA12
Results obtained in the clinical studies for each of the components are summarised in the tables below:
Riżultati ta ’ studji kliniċi li saru għall kull komponent huma mniżżlin fil- qosor fit- tabelli hawn taħt:
Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Infanrix Penta
6 Persentaġġ ta 'suġġetti b’ livelli ta ’ antikorpi ≥ analiżi cut- off xahar wara l- vaċċinazzjoni primarja b’ Infanrix Penta
3-5
3- 5 xhur
(cut-off)
Antikorpi
Anti-tetanus (0.1 IU/ ml) †
Anti- diphtheria (0. 1 IU/ ml) † Anti- tetanus (0. 1 IU/ ml) †
Anti-Polio type 1 (1/ 8 dilution) †
Anti- Polio tip 1 (dilwizzjoni1/ 8) †
Anti-Polio type 3 (1/ 8 dilution) † N = number of subjects ND = not determined
Anti- Polio tip 3 (dilwizzjoni 1/ 8) † N = numru ta ’ suġġetti ND = mhux determinat
6 * in a subgroup of infants not administered hepatitis B vaccine at birth, 80.2% of subjects had anti- HBs titres ≥ 10 mIU/ ml † cut-off accepted as indicative of protection
* f’ subgrupp ta ’ trabi li ma ngħatawx il- vaċċin ta ’ l- epatite B fit- twelid, 80. 2% tas- suġġetti kellhom livelli ta ’ antikorpi HB ≥ 10 mIU/ ml † cut- off aċċettata bħala indikazzjoni ta ’ protezzjoni
Percentage of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Infanrix Penta Antibody (cut-off)
Persentaġġ ta ’ suġġetti b’ livelli ta ’ antikorpi ≥ analiżi cut- off xahar wara vaċċinazzjoni boosterb’ Infanrix penta Antikorpi
Booster vaccination at 11/ 12 months of age
Tilqima booster ta ’
Booster vaccination during the second
Vaċċinazzjoni booster
following a 3-5 month year of life following a
11/ 12- il - xahar wara
primary course N = 168
matul it- tieni sena ta ’
three
kors primarju ta ’ bejn
dose primary course N = 350
ħajja wara kors
100
3- 5 xhur N = 168 100
100
ta ’ tlett dożi = 350 100
Anti-Polio type 3 (1/ 8 dilution) † N = number of subjects
Anti- Polio tip 3 (dilwizzjoni 1/ 8) † N = numru ta ’ suġġetti
† cut-off accepted as indicative of protection
† cut- off aċċettat bħala indikazzjoni ta ’ protezzjoni
As the immune response to pertussis antigens following Infanrix Penta administration is equivalent to that of Infanrix, the protective efficacy of the two vaccines is expected to be equivalent.
7 Billi ir- rispons immuni għal antiġeni ta ’ pertussis wara it- tehid ta ’ Infanrix Penta huma ekwivalenti għal dawk ta ’ Infanrix, l- effikaċja protettiva taż- żewġ vaċċini hija mistennija li tkun l- istess.
The clinical protection of the pertussis component of Infanrix, against WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) was demonstrated in:
Il- protezzjoni klinika tal- komponent ta ’ pertussis ta ’ Infanrix, kontra s- sogħla konvulsiva tipika kif deskritta mill- WHO (≥ 21 ġurnata ta ’ attakki ta ’ sola) ġiet osservata fi:
- a NIH sponsored efficacy study performed in Italy (2, 4, 6 months schedule).
- Studju dwar l- effikaċja, sponsorjat mill- NIH li sar ġewwa l- Italja (skeda ta ’ 2, 4, 6 xhur).
The vaccine
Instab li l -
efficacy was found to be 84%.
effikaċja tal- vaċċin kienet ta ’ 84%.
In a follow-up of the same cohort, the efficacy was confirmed up to 60 months after completion of primary vaccination without administration of a booster dose of pertussis.
Mill- istess studju li tkompla wara ftit żmien, ġie kkonfermat li l- vaċċin jibqa effikaċi sa 60 xhar wara li jittieħed il- kors primarju kollu mingħajr ma tingħata doża booster ta ’ pertussis.
Protective antibodies against hepatitis B have been shown to persist for at least 3.5 years in more than 90% of children administered four doses of a combined vaccine containing the same HBs antigen as 7 Infanrix Penta.
Antikorpi prottettivi kontra l- epatite B dehru li ppersistew mill- anqas 3. 5 snin f’ aktar minn 90% ta ’ tfal li ħadu erba ’ dożi ta ’ vaċċin kombinat li fih l- istess antiġen HB bħal Infanrix Penta.
Evaluation of pharmacokinetic properties is not required for vaccines.
Evalwazzjoni ta ’ tagħrif farmakokinetiku mhiex neċessarja għall- vaċċini.
5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurta 'tal- mediċina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity, repeated dose toxicity and compatibility of ingredients.
Informazzjoni li mhiex klinika magħmula fuq studji konvenzjonali ta ’ sigurta ’, tossċità speċifika, tossiċità minn dożi ripetuti u kompatibilita ’ ta ’ l- ingredjenti ma wrew l- ebda periklu speċjali għal bnedmin.
Sodium chloride (NaCl) Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
Sodium Chloride (NaCl) Medium 199 li fih prinċipalment amino acids, mineral salts, vitamini Ilma għall- injezzjonijiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m' għandux jitħallat ma 'prodotti mediċinali oħrajn.
Upon removal from the refrigerator, the vaccine is stable for 8 hours at 21°C.
8 Wara li jitneħħa minn ġol- friġġ, il- vaċċin jibqa tajjeb għal 8 sigħat f’ temperatura ta ’ + 210C
Do not freeze.
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża
0.5 ml of suspension in a pre-filled syringe (type I glass) with plunger stoppers (butyl).
0. 5mL ta ’ suspensjoni ġo siringa mimlija lesta (ħġieġ tip I) b' tappijiet għal- plunger (butyl).
Pack sizes of 1, 10, 20 and 50 with or without needles.
Pakketti ta ’ 1, 10, 20 u 50 bil- labar jew mingħajr labar.
Upon storage, a white deposit and clear supernatant may be observed.
Meta jinħażen, depożitu abjad u sustanza ċara f' wiċċ l- ilma jistgħu jidhru.
The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.
Is- siringa trid titħawwad sew biex is- suspensjoni tkun waħda uniformi, bajda u mdardra.
8 The DTPa-HBV-IPV suspension should be inspected visually for any foreign particulate matter and/ or abnormal physical. appearance.
Is- suspensjoni tad- DTPa- HBV- IPV għandha tkun spezzjonata viżwalment biex wieħed jara jekk hemmx xi frak jew/ u xi dehra fiżika mhux normali.
In the event of either being observed, discard the vaccine.
F’ każ li jiġri hekk, il- vaċċin għandu jintrema.
Any unused product of waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA' L - AWTORIZZAZZJONI
CONDITIONS OF THE MARKETING AUTHORISATION
DATA TA 'META ĠIET RIVEDUTA L- KITBA
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Name and address of the manufacturers of the biological active substances
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Rue de l’ Institut 89, 1330 Rixensart Belgium
Rue de l’ Institut 89, 1330 Rixensart Il- Belġju
76, D-35041 Marburg Germany
76, D- 35041 Marburg Il- Ġermanja
Official batch release: in accordance with Article 114 of Directive2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 20 PRE-FILLED SYRINGES WITHOUT NEEDLES 50 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 20 PRE-FILLED SYRINGES WITH 20 NEEDLES 50 PRE-FILLED SYRINGES WITH 50 NEEDLES 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA 1 SIRINGA MIMLIJA LESTA MINGĦAJR LABBRA 10 SIRINGI MIMLIJIN LESTI MINGĦAJR LABAR 20 SIRINGA MIMLIJIN LESTI MINGĦAJR LABAR 50 SIRINGA MIMLIJIN LESTI MINGĦAJR LABAR 1 SIRINGA MIMLIJA LESTA B’ LABRA WAĦDA 10 SIRINGI MIMLIJIN LESTI B’ 10 LABRIET 20 SIRINGA MIMLIJIN LESTI B’ 20 LABRA 50 SIRINGA MIMLIJIN LESTI B’ 50 LABRA 1 SIRINGA MIMLIJA LESTA B’ 2 LABRIET 10 SIRINGI MIMLIJIN LESTI B’ 20 LABRA
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA/ I
1 dose (0.5 ml):
Doża 1 (0. 5 ml):
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis antigens
Toxoid tad- difterite1 Toxoid tat- tetnu 1 Antiġeni tal- Bordatella Pertussis
(Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1) Hepatitis B surface antigen2 Poliovirus (inactivated) type 1, 2, 3 1
(Toxoid tal- Pertussis1, Filamentous Haemagglutinin1, Periactin1) L- antiġen tas- superfiċje ta ’ l- epatite B2 Poliovirus (inattivat) tip 1, 2, 3 1
25, 8 micrograms 10 micrograms 40, 8, 32 DU
25, 25, 8 mikrogrammi 10 mikrogrammi 40, 8, 32 DU
adsorbed on Al(OH)3 2
adsorbit fuq Al( OH) 3 2
adsorbed on AlPO4
adsorbit fuq AlPO4
Sodium chloride Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
Sodium chloride Medium 199 li fih prinċipalment amino acids, mineral salts, vitamini Ilma għall- injezzjonijiet
Suspension for injection 1 pre-filled syringe 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni Siringa 1 mimlija lesta Doża 1 (0. 5ml)
10 pre-filled syringes 10 x 1 dose (0.5 ml)
10 siringi mimlijin lesti 10 x 1 doża (0. 5 ml)
20 pre-filled syringes 20 x 1 dose (0.5 ml)
20 siringa mimlijin lesti 20 x 1 doża (0. 5 ml)
50 pre-filled syringes 50 x 1 dose (0.5 ml)
50 siringa mimlijin lesti 50 x 1 doża (0. 5 ml)
14 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
15 1 siringa mimlija lesta + 1 labra 1 doża (0. 5 ml)
10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
10 siringi mimlijin lesti + 10 labriet 10 x 1 doża (0. 5 ml)
20 pre-filled syringes + 20 needles 20 x 1 dose (0.5 ml)
20 siringi mimlijin lesti + 20 labra 20 x 1 doża (0. 5 ml)
50 pre-filled syringes + 50 needles 50 x 1 dose (0.5 ml)
50 siringa mimlijin lesti + 50 labra 50 x 1 doża (0. 5 ml)
1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
1 siringa mimlija lesta + 2 labriet 1 doża (0. 5 ml)
10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 siringi mimlijin lesti + 20 labra 10 x 1 doża (0. 5 ml)
Read the package leaflet before use Intramuscular use Shake before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu Jintuża għal ġol- muskolu Ħawwad sew qabel l- użu
MM/ YYYY
[XX/ SSSS]
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
Aħżen fi friġġ Tagħmlux fil- friża Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl
EU/ 1/ 00/ 153/ 001 - 1 pre-filled syringe without needle EU/ 1/ 00/ 153/ 002 - 10 pre-filled syringes without needles EU/ 1/ 00/ 153/ 003 - 20 pre-filled syringes without needles EU/ 1/ 00/ 153/ 004 - 50 pre-filled syringes without needles EU/ 1/ 00/ 153/ 005 - 1 pre-filled syringe with 1 needle EU/ 1/ 00/ 153/ 006 - 10 pre-filled syringes with 10 needles EU/ 1/ 00/ 153/ 007 - 20 pre-filled syringes with 20 needles EU/ 1/ 00/ 153/ 008 - 50 pre-filled syringes with 50 needles EU/ 1/ 00/ 153/ 009 - 1 pre-filled syringe with 2 needles EU/ 1/ 00/ 153/ 010 - 10 pre-filled syringes with 20 needles
EU/ 1/ 00/ 153/ 001 - 1 siringa mimlija lesta mingħajr labra EU/ 1/ 00/ 153/ 002 - 10 siringi mimlijin lesti mingħajr labar EU/ 1/ 00/ 153/ 003 - 20 siringa mimlijin lesti mingħajr labar EU/ 1/ 00/ 153/ 004 - 50 siringa mimlijin lesti mingħajr labar EU/ 1/ 00/ 153/ 005 - 1 siringa mimlija lesta b’ labra 1 EU/ 1/ 00/ 153/ 006 - 10 siringi mimlijin lesti b’ 10 labriet EU/ 1/ 00/ 153/ 007 - 20 siringa mimlijin lesti b’ 20 labra EU/ 1/ 00/ 153/ 008 - 50 siringi mimlijin lesti b’ 50 labra EU/ 1/ 00/ 153/ 009 - 1 siringa mimlija lesti b’ 2 labriet EU/ 1/ 00/ 153/ 010 - 10 siringi mimlijin lesti b’ 20 labra
Lot
Lott:
Infanrix Penta Suspension for injection DTPa-HBV-IPV IM
Infanrix Penta Suspensjoni għall- injezzjoni DTPa- HBV- IPV IM
1 dose (0.5 ml)
Doża 1 (0. 5ml)
18 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF
INFORMATION FOR THE USER
19 FULJETT TA 'TAGĦRIF:
Infanrix Penta, Suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Infanrix Penta, Suspensjoni għall- injezzjoni Vaċċin (adsorbit) għad- difterite (D), tetnu (T), sogħla konvulsiva (partijiet taċ- ċellula, komponent) (Pa), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV)
Read all of this leaflet carefully before your child receives this vaccine.
Aqra dan il- fuljett kollu qabel ibnek/ bintek jieħu din it- tilqima.
- Keep this leaflet until your child has finished the complete vaccination course.
- Żomm dan il- fuljett sakemm ibnek/ bintek itemmu l- kors kollu ta 'din it- tilqima.
- If you have any further questions, ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
- This vaccine has been prescribed for your child.
- Din il- mediċina ġiet mogħtija għat- tifel/ tifla tiegħek.
What Infanrix Penta is and what it is used for 2.
X' inhi Infanrix Penta u għalxiex tintuża 2.
Before your child receives Infanrix Penta 3.
Qabel ma ibnek/ bintek jieħdu Infanrix Penta 3.
How Infanrix Penta is given 4.
Kif tingħata Infanrix Penta 4.
Possible side effects 5.
X' effetti oħra jista 'jkollha 5.
How to store Infanrix Penta 6.
Kif taħżen Infanrix Penta 6.
WHAT Infanrix Penta IS AND WHAT IT IS USED FOR
X' INHI Infanrix Penta U GĦALXIEX TINTUŻA
Infanrix Penta is a vaccine used in children to prevent five diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B and poliomyelitis (Polio).
Infanrix Penta hija vaċċin għat- tfal biex tilqa ’ kontra ħames mardiet infettivi: difterite, tetnus (lockjaw), pertussis (sogħla konvulsiva), epatite B u poljomelite (Poljo).
The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Il- vaċċin jaħdem billi jġiegħel lill- ġisem jipproduċi l- protezzjoni (anti- korpi) tiegħu stess kontra dan il- mard infettiv.
Diphtheria mainly affects the airways and sometimes the skin.
Id- Difterite taffettwa l- aktar il- passaġġi tan- nifs u kultant il- ġilda.
Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.
Ġeneralment il - passaġġi tan- nifs jiffjammaw (jintefħu) u dan jikkawża qtugħ ta 'nifs sever u kultant jifga lil dak li jkun.
The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.
Il- batterji jipproduċu tossin (velenu), li jista 'jagħmel ħsara fin- nervaturi, joħloq problemi fil- qalb u anki jikkawża l- mewt.
• Tetanus (Lockjaw):
• Tetnu (Lockjaw):
Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Il- batterji tat- tetnu jidħlu fil- ġisem minn qsim, brix jew feriti fil- ġilda.
Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/ dung or wood splinters.
Feriti li faċilment iġibu infezzjoni huma ħruq tal- ġilda, ksur ta 'għadam, feriti fondi jew feriti mniġġsa bil- ħamrija, trab, ħmieġ/ demel taż- żwiemel jew skald.
The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death.
Il- batterji jitilqu tossin (velenu), li jista 'jikkawża ebusija fil- muskoli, spażmi li juġgħaw fil- muskoli, aċċessjonijiet u anke l- mewt.
The muscle spasms can be strong enough to cause bone fractures of the spine.
L - ispażmi muskolari jistgħu ikunu tant qawwija li anki jaslu biex jiksru xi għadam tax- xewka tad - dahar.
Pertussis is a highly infectious illness.
Pertussis hi marda li tittieħed ħafna.
The disease affects the airways causing severe spells of coughing that may interfere with normal breathing.
Il- marda taffettwa l- passaġġi tan- nifs u ġġib magħha attakki ta 'sogħla fit- tul li jistgħu jaffettwaw in- nifs.
The coughing is often accompanied by a “ whooping” sound, hence the common name “ whooping cough”.
Is- sogħla ħafna drabi ġġib magħha tħarħir (whooping), mnejn ġie l- isem komuni “ whooping cough ” (sogħla konvulsiva).
The cough may last for 1-2 months or longer.
Is- sogħla tista 'ddum xahar jew xahrejn u anki aktar.
Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death.
Pertussis tista 'wkoll tikkawża infezzjonijiet fil- widnejn, bronkite li tista' tieħu fit- tul, pulmonite, aċċessjonijiet, ħsara fil- moħħ u anki mewt.
Hepatitis B is caused by the hepatitis B virus.
Epatite B hija infezzjoni kkawżata mill- virus ta 'l- epatite B.
It causes the liver to become swollen (inflamed).
Din tista 'ġġib nefħa (infjammazjoni) fil- fwied.
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Il- virus ikun fil- fluwidi tal- ġisem bħad- demm, sperma, tnixxijiet tal - vaġina, jew saliva (bżieq) ta 'nies infettati.
• Poliomyelitis (Polio):
• Poljomelite (Poljo):
Poliomyelitis, sometimes called simply “ polio” is a viral infection that can have variable effects.
Poljomelite, xi kultant msejħa ‘ poljo ’ hija infezzjoni virali li jista jkollha effetti varji.
In its severest form, polio infection causes paralysis of the muscles (muscles cannot move), including those muscles needed for breathing and walking.
20 jistgħu jiċċaqalqu), li jinkludi dawk il- muskoli li huma meħtieġa għan- nifs jew għall- mixi.
The limbs affected by the disease may be painfully deformed.
Ir - riġlejn jew dirgħajn affettwati minn din il- marda jistgħu jiġu sfigurati u jkunu juġgħaw.
19 Vaccination is the best way to protect against these diseases.
It- tilqim hu l- aħjar protezzjoni kontra dan il- mard.
None of the components in the vaccine are infectious.
L- ebda komponent tal- vaċċin ma huwa infettiv.
BEFORE YOUR CHILD RECEIVES Infanrix Penta
QABEL MA IBNEK/ BINTEK JIEĦDU Infanrix Penta
Infanrix Penta should not be given:
Infanrix Penta m’ għandhiex tingħata:
• if your child has previously had any allergic reaction to Infanrix Penta, or any ingredient contained in this vaccine.
• jekk ibnek/ bintek qatt kellhom xi reazzjoni allerġika għal Infanrix Penta, jew għal xi sustanza li jkun fih dan il- vaċċin.
The active substances and other ingredients in Infanrix Penta are listed at the end of the leaflet.
Is- sustanzi attivi jew sustanzi oħra li jkun hemm f’ Infanrix Penta huma elenkati fit- tmiem tal- fuljett.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough), hepatitis B or poliomyelitis diseases. • if your child experienced problems of the nervous system within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease. • if your child has a severe infection with a high temperature (over 38°C).
Sinjali ta 'reazzjoni allerġika jistgħu jinkludu raxx fil- ġilda flimkien ma' ħakk, qtugħ ta 'nifs u nefħa fil- wiċċ jew fl- ilsien. • Jekk ibnek/ bintek qatt kellhom xi reazzjoni allerġika għal xi vaċċin kontra d- difterite, it- tetnu, il - pertussis (sogħla konvulsiva), l- epatite B jew il- poljomelite. • Jekk ibnek/ bintek qatt kellhom xi problemi fis- sistema nervuż fi żmien sebat ijiem wara li jkunu tlaqqmu kontra l- pertussis (sogħla konvulsiva) • Jekk ibnek/ bintek għandhom xi infezzjoni qawwija b' deni għoli (aktar minn 38°C).
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Infezzjoni żgħira bħal riħ m' għandhiex tkun problema, imma l- ewwel għandek tkellem lit- tabib tiegħek.
Take special care with Infanrix Penta
Oqgħod attent ħafna b’ Infanrix Penta
• if after previously having Infanrix Penta or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/ fits with or without a high temperature within 3 days of vaccination • if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
• jekk wara xi tilqim fl- imgħoddi b’ Infanrix Penta jew xi vaċċin ieħor kontra l- pertussis (sogħla konvulsiva), ibnek/ bintek kellhom xi problemi, speċjalment: ♦ Deni għoli ('il fuq minn 400C) fi żmien 48 siegħa mit- tilqima ♦ Kollass jew stat qisu ta' xokk fi żmien 48 siegħa mit- tilqima ♦ Biki persistenti ta 'xi tlett sigħat sħaħ jew iżjed fi żmien 48 siegħa mit- tilqima ♦ Aċċessjonijiet b' deni qawwi jew bla deni fi żmien tlett ijiem mit- tilqima • jekk ibnek/ bintek qed ibatu minn xi marda tal- moħħ mhux dijanjostikata jew progressiva jew epilessija mhux ikkontrollata.