qanastek/EMEA-V3 huggingface dataset:
Pertussis toxoid1 Filamentous Haemagglutinin1 Pertactin1 Hepatitis B surface antigen2,3 Poliovirus (inactivated)
Toxoid tal- Pertussis1 Filamentous Haemagglutinin1 Pertactin1 Antiġen tas- superfiċje ta ’ l- epatite B 2, 3 Poliovirus (inattivat)
Haemophilus type b polysaccharide (polyribosylribitol phosphate) 3
tip 1 (tar- razza Mahoney) 4 tip 2 (tar- razza MEF- 1) 4 tip 3 (tar- razza Saukett) 4 Haemophilus tip b polysaccharide (polyribosylribitol phosphate) 3
10 micrograms
40 Unita ’ ta ’ D- antiġen 8 Unita ’ ta ’ D- antiġen 32 Unita ’ ta ’ D- antiġen 10 mikrogrammi
conjugated to tetanus toxoid as carrier protein 1
konjugat ma toxoid tat- tetnu bħala proteina ġarriera 1
adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 2
adsorbit fuq aluminium oxide hydrated (Al( OH) 3 2
0.5 milligrams Al
0. 5 milligrammi Al
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3 adsorbed on aluminium phosphate (AlPO4) 4 propagated in VERO cells
adsorbit fuq aluminium phosphate (AlPO4) 4 propogati f’ ċelloli VERO
0.32 milligrams Al
0. 32 milligrammi Al
Powder and suspension for suspension for injection.
Trab u suspensjoni għal suspensjoni għall- injezzjoni.
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension.
Is- suspensjoni tad- difterite, tetnu, pertussis aċellulari, epatite B, poljomelite inattivat (DTPa- HBV - IPV) hija bajda u mdardra.
The lyophilised Haemophilus influenzae type b (Hib) component is a white powder.
Il- komponent tal- Haemophilus influenzae tip b (Hib) lajofiliżżat huwa trab abjad.
4.1 Therapeutic indications
4. 1 Indikzzjonijiet terapewtiċi
Infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b.
Infanrix hexa hija indikata għat- tilqim primarju u tilqim booster għal trabi kontra d- difterite, tetnu, pertussis (sogħla konvulsiva), epatite B, poljomelite u mard ieħor kkawżat minn Haemophilus influenzae tip b.
Infanrix hexa is not intended for use in children over 36 months of age.
Infanrix hexa mhux addatata fi tfal ta ’ fuq is- 36 xahar
Primary vaccination:
2 Tilqim primarju:
2 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).
2, 4, 6 xhur:
There should be an interval of at least 1 month between doses.
3, 5 u 11 jew 12 - il xahar) jew żewġ dożi (bħal 3, 5 xhur).
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.
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 lokali li ġew stabbiliti kontra l- epatite B għandhom jibqgħu jiġu osservati.
Where a dose of hepatitis B vaccine is given at birth, Infanrix hexa 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 hexa tista tingħata minflok dożi supplementarji tal- vaċċin ta ’ l- epatite B mill- eta ta`sitt gimgħat ’ 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 monovalent ta ’ l- epatite B.
Booster vaccination:
Tilqim booster:
After a vaccination with 2 doses (e. g.
Wara tilqima b’ żewġ dożi (e. ż.
3, 5 months) of Infanrix hexa 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 ’ Infarix Hexa għandha tingħata doża booster mill- inqas 6 xhur wara l- aħħar doża primarja, preferibbilment bejn l- eta ’ ta ’ 11 u 13 - il xahar.
After vaccination with 3 doses (e. g.
Wara tilqima bi tlett dożi (e. ż.
2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) of Infanrix hexa 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 hexa għandha tingħata doża booster mill- inqas 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, but, as a minimum, a dose of Hib conjugate vaccine must be administered.
Dożi booster għandhom jingħataw skond ir- rakkomandazzjonijiet uffiċjali, iżda bħala minimu, għandha tingħata doża tal- vaċċin konġugat tal- Hib.
Infanrix hexa can be considered for the booster if the composition is in accordance with the official recommendations.
Infanrix hexa tista ’ tiġi kkunsidrata bħala booster jekk tkun magħmula skond ir- rakkomandazzjonijiet uffiċjali
Infanrix hexa is for deep intramuscular injection, preferably at alternating sites for subsequent injections.
Infanrix hexa tingħata bħala injezzjoni ġol- muskolu fil- fond, preferibbilment 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, polio or Hib vaccines.
Sensittivita ’ eċċessiva wara tilqim li jkun ingħata qabel għad- difterite, tetnu, sogħla konvulsiva, epatite B, polio jew Hib.
Infanrix hexa is contraindicated if the infant has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Infanrix hexa m`għandiex tingħata lit- trabi jekk dawn kellhom enċefalopatija ta ’ etjoloġija mhux magħrufa, li tkun seħħet fi żmien sebat ijiem wara tilqima preċedenti bil- vaċċin tal- pertussis.
In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio and Hib vaccines.
F`dawn il- każijiet it- tilqim tal- pertussis għandu jitwaqqaf u l- kors ta` tilqim għandu jitkompla bil- vaċċini ta ’ kontra d- difterite- tetnu, l- epatite B, il- polio u l- Hib.
As with other vaccines, administration of Infanrix hexa should be postponed in subjects suffering from acute severe febrile illness.
Bħall kull vaċċin ieħor l- użu ta` Infanrix hexa m`għandux jitkompla f`individwi li jbgħatu min mard bħal mard b’ deni għoli u akut.
The presence of a minor infection is not a contraindication.
Il- preżenza ta` infezzjoni żgħira m' għandhiex tindika li t- tilqima m' għandhiex issir.
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 jingħata wara eżami tal- passat mediku (b`mod speċjali fejn jirrigwardja xi tilqim ta ’ qabel li seta ’ kellu 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:
3 Jekk hu magħruf li xi wieħed minn dawn l- effetti deher u kien relatat temporanjament mat- teħid ta ’ tilqim tal- pertussis, wieħed għandu jikkunsidra bir- reqqa jekk għandhomx jingħataw dożi oħra tal - vaċċin tal- pertussis.
Temperature of ≥ 40.0°C within 48 hours, not due to another identifiable cause.
Temperatura ta ’ ≥ 40. 0°C fi żmien 48 siegħa, mhux minħabba kawża oħra magħrufa.
3 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.
Biki kontinwu u persistenti, għal ≥ 3 sigħat, fi żmien 48 sigħat mit- tilqima.
Convulsions with or without fever, occurring within 3 days of vaccination.
Aċċessjonijiet bid- deni jew mingħajr deni, fi żmien tlett ijiem mit- tilqima.
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` pertusis, meta l- benefiċċji li wieħed jistenna jkunu akbar mir- riskji possibli.
As for any vaccination, the risk-benefit of immunising with Infanrix hexa 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 jikber bil- ftit il- ftit, il- benefiċji u r- riskji ta ’ tilqim b’ Infanrix hexa 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 hexa 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 hexa għandha tingħata b`attenzjoni f’ individwi bi tromboċitopenja jew xi kundizzjoni ta ’ fsada (ħruġ ta ’ demm) għax jista ’ joħroġ id- demm wara li tingħata t- tilqima fil- muskolu lil dawn l - individwi.
Infanrix hexa should under no circumstances be administered intravascularly or intradermally.
Infanrix hexa m' għandha qatt tingħata b' mod intravaskulari jew taħt il- ġilda.
Infanrix hexa will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b.
Infanrix hexa 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.
However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Madankollu, jista jkun mistenni li jkun hemm prevenzjoni ta 'l- epatite D bl- immunizzazzjoni għax l- epatite D (ikkawżata mill- aġent delta) ma titteħidx fl- assenza ta ’ infezzjoni bl- epatite B.
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1).
Bħal f’ kull vaċċin ieħor, jista ’ ma jkunx stimulat rispons immuni prottettiv f’ kull min jieħu l- vaċċin (ara sezzjoni 5. 1).
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 hexa.
Jekk fil- passat kien hemm xi aċċessjonijiet bid- deni, aċċessjonijiet jew Sindromu ta 'Mewt f' Daqqa fit - Tfal (SIDS), fil- passat mediku tal- familja, ma jfissirx li l- użu ta ’ Infanrix hexa huwa kontraindikat.
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 b’ passat ta ’ aċċessjonijiet bid- deni għandhom jiġu 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` l- HIV mhix meqjusa bħala kontra- indikazzjoni.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Ir- rispons immunoloġiku mistenni jista ’ ma jintlaħaqx meta jitlaqqmu pazjenti li huma immunosoppressi.
Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1-2 weeks following vaccination.
Billi l- antiġen polysaccharide kapsulari tal- Hib deher fl- urina, jista ’ jiġi osservat test posittiv ta ’ l - urina minn 1- 2 ġimgħat wara t- tilqima.
Other tests should be performed in order to confirm Hib infection during this period.
Jistgħu isiru testijiet oħra biex tkun ikkonfermata infezzjoni b’ Hib f’ dan il- perjodu.
When Infanrix hexa is co-administered with Prevenar (pneumococcal saccharide conjugated vaccine, adsorbed), the physician should be aware that data from clinical studies indicate that the rate of febrile reactions was higher compared to that occurring following the administration of Infanrix hexa alone.
Meta Infanrix hexa tingħata flimkien ma ’ Prevenar (vaċċin konjugat adsorbit ta ’ pneumococcal saccharide), it- tabib għandu jkun jaf li l- informazzjoni minn studji kliniċi tindika li f’ dan il- każ r- rata tar- reazzjonijiet bid- deni kienet aktar minn dik li seħħet wara tilqim b’ Infanrix hexa waħedha.
These reactions were mostly moderate (less than or equal to 39°C) and transient (see section 4.8).
Il- biċċa l- kbira ta ’ dawn ir- reazzjonijiet kienu moderati (temperatura ta ’ jew inqas minn 39°C) u temporanji (ara sezzjoni 4. 8).
Antipyretic treatment should be initiated according to local treatment guidelines.
Kura għal kontra d- deni għandha tinbeda skond il- linji gwida tat- trattament lokali.
Limited data in 169 premature infants indicate that Infanrix hexa can be given to premature children.
Data limitata f’ 169 trabi prematuri uriet li Infanrix hexa tista ’ tingħata lil tfal prematuri.
However, a lower immune response may be observed and the level of clinical protection remains unknown.
Madankollu, jista ’ jkun osservat rispons immuni aktar baxx u l- livell ta ’ protezzjoni klinika tibqa mhux magħrufa.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
4 qabel iż- żmien (twieldu ≤ 28 ġimgħa ta ’ tqala) u speċjalment f’ dawk li diġà kellhom immaturità respiratorja.
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Minħabba li l - vaċċinazzjoni f' dan il- grupp ta 'trabi hija ta ’ ġid kbir, t- tilqim m’ għandux jinżamm lura jew jiġi pospost.
4 There are insufficient data with regard to the efficacy and safety of simultaneous administration of Infanrix hexa and Measles-Mumps-Rubella vaccine to allow any recommendation to be made.
M’ hemmx informazzjoni biżżejjed dwar is- sigurta ’ u l- effikaċja ta ’ Infanrix hexa meta tingħata fl - istess ħin mat- tilqim tal- Ħożba- Gattone- Rubella biex tista ’ ssir xi rakkomandazzjoni.
Data on concomitant administration of Infanrix hexa with Prevenar (pneumococcal saccharide conjugated vaccine, adsorbed) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.
L- informazzjoni li hemm, dwar l- użu ta ’ Infanrix hexa flimkien ma ’ Prevenar (vaċċin konjugat adsorbit ta ’ pneumococcal saccharide) ma wrew l- ebda interferenza ta ’ rilevanza klinika fir- rispons ta ’ l- anti- korpi għal kull antiġen individwali meta jingħata bħala tilqima primarja ta ’ tlett dożi.
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, huwa mistenni li f`pazjenti li qed jirċievu terapija immuno- soppressiva jista ’ ma jitlaħaqx ir- rispons adegwat.
As Infanrix hexa is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Peress li Infanrix hexa mhux intenzjonat għal użu fl- adulti, ma teżisti l- ebda informazzjoni dwar l- użu tal- vaċċin waqt it- tqala jew treddigħ u m`hemm l- ebda studju adegwat fuq l- effett tal- vaċċin fuq ir - riproduzzjoni ta ’ l- annimali
Not relevant.
Mhux rilevanti
• Clinical trials:
• Provi kliniċi:
The safety profile presented below is based on data from more than 16,000 subjects.
Il- profil ta ’ sigurta ’ ppreżentat hawn taħt huwa bbażat fuq data minn aktar minn 16, 000 suġġett.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix hexa with respect to the primary course.
Bħal ma ’ ġie osservat bil- vaċċin DTPa u vaċċini kombinati li fihom DTPa, meta ngħatat vaċċinazzjoni booster b’ Infanrix hexa, ġiet rapportata żjieda f`rejatoġeniċita ’ lokali u deni meta mqabbla mal- kors primarju.
Clinical trials on co-administration:
Provi kliniċi dwar l- użu ma tilqim ieħor:
In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar as a booster (4th) dose of both vaccines, fever ≥ 38.0°C was reported following 43.4% of doses in infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of doses in infants receiving the hexavalent vaccine alone.
Fi studji kliniċi fejn xi nies imlaqqma ingħataw Infanrix hexa flimkien ma 'Prevnar bħala doża booster (4a) taż- żewġ tilqimiet, ġie rrapurtat deni ≥ 38. 0˚C wara 43. 4% tad- dożi fi trabi li ingħataw Prevnar u Infanrix hexa fl- istess ħin meta mqabbla ma ’ 30. 5% tad- dożi fi trabi li ingħataw it- tilqima eżavalenti waħedha.
Fever of greater than 39.5°C was observed following 2.6% and 1.5% of doses in infants receiving Infanrix hexa with or without Prevenar, respectively, (see section 4.4).
Kien osservat deni ta ’ aktar minn 39. 5˚C wara 2. 6% u 1. 5% tad- dożi fi trabi li rċevew Infanrix hexa ma ’ Prevnar jew waħedha, rispettivament, (ara sezzjoni 4. 4).
The incidence of fever following co-administration of the two vaccines in the primary series was lower than that observed after the booster dose.
L- inċidenza ta ’ deni wara t- tehid flimkien taż- żewġ tilqimiet fis- serje primarja kien aktar baxxa minn dik osservata wara d- doża booster.
Frequencies per dose are defined as follows:
5
(≥ 1/ 10) (≥ 1/ 100 to < 1/ 10) (≥ 1/ 1,000 to < 1/ 100) (≥ 1/ 10,000 to < 1/ 1,000) (< 1/ 10,000)
(≥ 10%) (≥ 1% u < 10%) (≥ 0. 1% u < 1%) (≥ 0. 01% u < 0. 1%) (< 0. 01%)
Nervous system disorders:
Disturbi fis- sistema Mhux komuni: ngħas
Uncommon: somnolence Very rare: convulsions (with or without fever)
Rari ħafna: aċċessjonijiet (bi jew mingħajr deni)
Respiratory, thoracic and mediastinal disorders
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: sogħla
Common: diarrhoea, vomiting
Disturbi gastro- intestinali Komuni: dijarrea, rimettar
Skin and subcutaneous tissue disorders Rare: rash Very rare: dermatitis
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Rari: raxx Rari ħafna: dermatite
Metabolism and nutrition disorders Very common: appetite lost
Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni ħafna: nuqqas ta ’ aptit
Very common: fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain, redness Common: fever > 39.5°C, injection site reactions, including induration, local swelling at the injection site (> 50 mm)*, injection site reaction Uncommon: diffuse swelling of the injected limb, sometimes involving the adjacent joint*
Komuni ħafna: deni ≥ 38˚C, nefħa fis- sit tat- tilqima (≤ 50 mm), għejja, uġigħ, ħmura Komuni: deni > 39. 5˚C, reazzjonijiet fis- sit ta ’ l- injezzjoni, li jinkudu egħbusiga, nefħa fis- sit tat - tilqima (> 50 mm) *, reazzjoni fis- sit ta ’ l- injezzjoni Mhux komuni: nefħa diffusa tas- sieq li fiha ngħatat l- injezzjoni, xi kultant li tinxtered mal- ġog ta ’ ħdeja *
Very common: crying abnormal, irritability, restlessness Common: nervousness
Komuni ħafna: biki mhux tas- soltu, irritabilita ’, nuqqas ta ’ sabar Komuni: nervożita ’
• Post marketing surveillance:
• Tagħrif ta ’ wara t- tqegħid fis- suq
Blood and lymphatic system disorders Lymphadenopathy
Disturbi tad- demm u tas- sistema limfatika Limfandenopatija
Collapse or shock-like state (hypotonic-hyporesponsiveness episode)
Disturbi fis- sistema nervuża Kollass jew stat bħal ta ’ xokk (episodju ta ’ hypotonic- hyporesponsiveness)
Apnoea [see section 4.4 for apnoea in very premature infants (≤ 28 weeks of gestation)] Skin and subcutaneous tissue disorders Angioedema
Disturbi respiratorji, toraċiċi u medjastinali Apnea [ara sezzjoni 4. 4 għal apnea fit- trabi mwieldin ħafna qabel iż- żmien (≤ 28 ġimgħa ta ’ tqala)]
General disorders and administration site conditions:
6 Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata:
Swelling of the entire injected limb*, extensive swelling reactions, injection site mass, injection site vesicles
Nefħa tas- sieq kollha li fiha ngħatat l- injezzjoni *, reazzjonijiet ta ’ nefħa estensiva, massa fis- sit ta ’ l - injezzjoni, nfafet fis- sit ta ’ l- injezzjoni
Immune system disorders Anaphylactic reactions, anaphylactoid reactions (including urticaria), allergic reactions (including pruritus)
Disturbi fis- sistema immuni Reazzjonijiet anafilattiċi, reazzjonijiet anafilattodi (li jinkludu urtikarja), reazzjonijiet allerġiċi (li jinkludu ħakk)
* 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 ċanż 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 t’ ijiem.
• Experience with hepatitis B vaccine:
• Esperjenza b`vaċċin ta ’ l- epatite B:
In extremely rare cases, paralysis, neuropathy, Guillain-Barré syndrome, encephalopathy, encephalitis and meningitis have been reported.
F`każijiet rari ħafna ġew irrappurtati, paralażi, newropatija, is- sindromu ta ’ Guillain- Barré, enkefalopatija, enkefalite u meninġite.
The causal relationship to the vaccine has not been established.
Ma ġiex stabbilit jekk dawn l- effetti kienux assoċjati mal - vaċċin.
Thrombocytopenia has been reported with hepatitis B vaccines.
Ġiet irrappurtata tromboċitopenja bil- vaċċini tal- epatite B.
No case of overdose has been reported.
L- ebda każ ta ’ dożi eċċessivi ma ġie rappurtat.
Bacterial and viral vaccines combined, ATC code J07CA09
Vaċċini batteriċi u virali kombinati, ATC code J07CA09
Results obtained in the clinical studies for each of the components are summarised in the tables below:
Riżultati ta` studji kliniċi għall kull komponenti huma mniżżlin fil- qosor fit- tabelli hawn taħt:
Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Infanrix hexa
Persentaġġ ta 'suġġetti b’ livelli ta ’ antikorpi ≥ analiżi cut- off xahar wara l- vaċċinazzjoni primarja b’ Infanrix hexa
Antibody
Antikorpi
Two doses
Żewġ dożi
Three doses
Tlett dożi
3-5 months
3- 5 xhur N= 530
3-4-5
2- 3- 4 xhur N= 196
6-10-14
2- 4- 6 xhur
N= 530
3- 4- 5 xhur
months months months
6- 10- 14 xhur
Anti-diphtheria (0.1 IU/ ml) †
Anti- diphtheria (0. 1 IU/ ml) †
100.0 100.0 100.0
100. 0 100. 0
100.0 100.0 99.8
100. 0 99. 8
100.0 100.0 99.7
100. 0 99. 7
99.5 98.9 98.0
98. 9 98. 0
Anti-Polio type 1 (1/ 8 dilution) †
Anti- Polio tip 1 (dilwizzjoni 1/ 8) †
100.0 99.9 99.7
99. 9 99. 7
Anti-Polio type 2 (1/ 8 dilution) †
Anti- Polio tip 2 (dilwizzjoni 1/ 8) †
Anti-Polio type 3 (1/ 8 dilution) †
Anti- Polio tip 3 (dilwizzjoni 1/ 8) †
98.8
99. 7
100.0 99.7 99.7
99. 7
Anti-PRP (0.15 μ g/ ml) † N = number of subjects
Anti- PRP (0. 15 μg/ ml) † N = numru ta ’ suġġetti
* in a subgroup of infants not administered hepatitis B vaccine at birth, 77.7% 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, 77. 7% tas- suġġetti kellhom livelli anti- HB ≥ 10 mIU/ ml † cut- off aċċettata bħala indikazzjoni ta ’ protezzjoni
7 Percentage of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Infanrix hexa
Persentaġġ ta ’ suġġetti b’ livelli ta ’ antikorpi ≥ analiżi cut- off xahar wara vaċċinazzjoni booster b’ Infanrix hexa
(cut-off)
Antikorpi (cut- off) Anti- diphtheria (0. 1 IU/ ml) †
months of age following a 3-5 month primary course N=532%
Tilqima booster ta ’ 11- il- xahar wara kors primarju ta ’ bejn 3- 5 xhur N=532% 100. 0
second year of life following a three dose primary course N= 2009%
Vaċċinazzjoni booster matul it - tieni sena ta ’ ħajja wara kors primarju ta ’ tlett dożi N= 2009% 99. 9
Anti-diphtheria (0.1 IU/ ml) †
Anti- tetanus (0. 1 IU/ ml) †
Anti-tetanus (0.1 IU/ ml) †
Anti- PT (5 EL. U/ ml)
Anti-PT (5 EL. U/ ml)
Anti- FHA (5 EL. U/ ml)
Anti-FHA (5 EL. U/ ml)
Anti- PRN (5 EL. U/ ml)
† cut-off accepted as indicative of protection
N = numru ta ’ suġġetti † cut- off aċċettata bħala indikazzjoni ta ’ protezzjoni
As the immune response to pertussis antigens following Infanrix hexa administration is equivalent to that of Infanrix, the protective efficacy of the two vaccines is expected to be equivalent.
Billi ir- rispons immuni għal antiġeni ta ’ pertussis wara it- tehid ta ’ Infanrix hexa 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 tal- pertussis ta ’ Infanrix, kif deskritta mill- WHO (≥ 21 ġurnata ta` attakki ta ’ sogħla) ġiet osservata fi:
- a prospective blinded household contact study performed in Germany (3, 4, 5 months schedule).
L- effikaċja tal -
Based on data collected from secondary contacts in households where there was an index case with typical pertussis, the protective efficacy of the vaccine was 88.7%.
protezzjoni tal- vaċċin kienet ta ’ 88. 7% u dan ir- riżultat huwa bbażat fuq informazzjoni miġbura minn kuntatti sekondarji ta ’ familji fejn kien hemm każ ċar ta ’ sogħla konvulsiva tipika.
- a NIH sponsored efficacy study performed in Italy (2, 4, 6 months schedule.
- studju dwar l- effikaċja, sponsorjar mill- NIH li sar ġewwa l- Italja (skeda ta ’ 2, 4, 6 xhur).
The vaccine efficacy
Instab li l -
was found to be 84%.
effikaċja tal- vaċċin kienet 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.
8 vaċċin jibqa effikaċi sa 60 xhar wara l- kors komplut ta` tlqim primarju mingħajr ma tingħata doża booster ta` pertussis.
Results of long term follow-up in Sweden demonstrate that acellular pertussis vaccines are efficacious in infants when administered according to the 3 and 5 months primary vaccination schedule, with a booster dose administered at approximately 12 months.
Riżultati minn follow- up fit- tul fl- Iżvezja juri li l- vaċċini ta ’ pertussis aċellulari huma effikaċi fi trabi meta mogħtija skond l- iskeda ta 'vaċċinazzjoni primarja ta' 3 u 5 xhur, b' doża booster mogħtija bejn wieħed u ieħor ta ’ 12- il- xahar.
However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 months schedule.
Madankollu, d- data tindika li l- protezzjoni kontra l- pertussis tista 'tkun qed tmajna bejn l- eta' ta '7- 8 snin b' din l- iskeda ta 3- 5- 12 xhur.
This suggests that a second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously been vaccinated following this particular schedule.
Dan jissuġġerixxi li t- tieni doża ta 'vaċċin ta ’ pertussis hija ġġustifikata fi tfal ta ’ bejn il- 5- 7 snin li qabel kienu imlaqqmin skond din l - iskeda partikolari.
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 Infanrix hexa.
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 ’ Infanrix Hexa.
Antibody levels were not different from what was observed in a parallel cohort administered 4 doses of monovalent hepatitis B vaccine.
Il- livelli ta’ antikorpi ma kienux differenti minn dak li kien osservat f’ ko- ort paralleli li ingħata 4 dożi tal- vaċċin monovalent ta ’ l- epatite B.
8 The effectiveness of the Hib component of Infanrix hexa has been, and continues to be, investigated via an extensive post-marketing surveillance study conducted in Germany.
L- effett tal- komponent Hib ta ’ Infanrix hexa, ġie u għadu qed jiġi nvestigat permezz ta ’ studju estensiv, dwar il- prodott wara li tpoġġa fuq is- suq, li sar fil- Ġermanja.
Over a five year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines, of which one was Infanrix hexa, was 90.4% for a full primary series and 100% for a booster dose (irrespective of priming).
Fuq perjodu ta ’ ħames snin wara it- teħid, l- effettivita ’ tal- komponenti tal- Hib ta ’ żewġ tilqimiet eżavalenti, fejn waħda minnhom kienet Infanrix hexa, kienet ta ’ 90. 4% għal kors primarju sħiħ u 100% għal doża booster (irrispettivament minn priming).
Evaluation of pharmacokinetic properties is not required for vaccines.
Ma hemmx għalfejn evalwazzjoni tat- tagħrif farmakokinetiku għat- tilqim
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 m’ hijiex klinika, magħmula fuq studji konvenzjonali dwar is- sigurta farmakoloġika, effett tossiku speċifiku, effett tossiċiku minn dożi repetuti, kompatibilita ’ ta ’ l- ingredjenti ma wrew l - ebda periklu speċjali għal bnedmin.
Hib powder:
Trab tal- Hib:
Sodium chloride (NaCl) Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
Suspensjoni ta ’ DTPa- HBV- IPV sodium chloride (NaCl), Medium 199 li prinċipalment fih amino acids, Mineral salts, Vitamini u Ilma għall- injezzjonijiet
After reconstitution: an immediate use is recommended.
Għandu jintuża immedjatament.
However the stability has been demonstrated for 8 hours at 21°C after reconstitution.
Madanakollu, ntwera li jibqa tajjeb għal 8 sigħat wara li jiġi rikostitwit, f’ temperatura ta ’ 21°C.
6.4 Special precautions for storage
9 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not freeze.
Aħżen fi friġġ (2°C - 8°C) Tagħmlux fil- friża
Store in the original package, in order to protect from light.
Aħżen fil- pakkett oriġinal sabiex tilqa ’ mid- dawl.
Powder in a vial (type I glass) with a stopper (butyl).
Trab ġo kunjett (ħġieġ tat- tip I) b’ tapp (butyl).
0.5 ml of suspension in a pre-filled syringe (type I glass) with plunger stoppers (butyl).
Suspensjoni għall- injezzjoni f`siringa mimlija lesta (ħġieġ tat- tip I) (0. 5 ml) b’ tappijiet għall- planġer (butyl).
Pack sizes of 1, 10, 20 and 50 with or without needles.
Pakketti f`qisien ta` 1, 10, 20 u 50 bil- labar jew mingħajr labar.
9 Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Upon storage, a white deposit and clear supernatant may be observed.
Meta jinħażen, depożitu abjad u sustanza ċara f- wiċċ l- ilma jistgħu jiġu osservati.
This does not constitute a sign of deterioration.
Dan ma jfissirx li l- prodott qiegħed jiħżien.
The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.
Is- siringa trid titħawwad sewwa sabiex is- suspensjoni tkun waħda uniformi, bajda u mdardra.
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 tiġi spezzjonata viżwalment biex wieħed jara jekk hemmx xi frak u/ jew xi dehra fiżika mhux normali.
In the event of either being observed, discard the vaccine.
F`każ li jiġri hekk, il- vaċċin għandu jintrema.
The vaccine is reconstituted by adding the contents of the syringe to the vial containing the Hib powder.
Il- vaċċin jiġi rikostitwit billi żżid l- kontenut tas- siringa fil- kunjett li fiha t- trab tal- HIB.
After the addition of the DTPa-HBV-IPV vaccine to the powder, the mixture should be well shaken until the powder is completely dissolved.
Wara li jiżdied il- vaċċin DTPa- HBV- IPV mat- trab, it- taħlita għandha tiġi mħallta sew sakemm it- trab jinħall kompletament.
The reconstituted vaccine presents as a slightly more cloudy suspension than the liquid component alone.
Il- vaċċin rikostitwit jidher bħala suspensjoni ftit iżjed imdardra mil- likwidu waħdu.
This is normal and does not impair the performance of the vaccine.
Din hija normali u bl- ebda mod ma taffettwa l- funzjoni tal- vaċċin.
In the event of other variation being observed, discard the vaccine.
F`każ li jidhru xi varjazzjonijiet oħra, armi l- vaċċin.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal ta ’ prodott li ma jkunx intuża jew skart li jibqa ’ wara għandu jintrema kif jitolbu l- liġijiet lokali
Rue de l'Institut 89 B-1330 Rixensart, Belgium
Rue de l' Institut 89 B- 1330 Rixensart, Belġju
MARKETING AUTHORISATION NUMBER(S
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
EU/ 1/ 00/ 152/ 001 EU/ 1/ 00/ 152/ 002 EU/ 1/ 00/ 152/ 003 EU/ 1/ 00/ 152/ 004 EU/ 1/ 00/ 152/ 005 EU/ 1/ 00/ 152/ 006 EU/ 1/ 00/ 152/ 007 EU/ 1/ 00/ 152/ 008
EU/ 1/ 00/ 152/ 001 EU/ 1/ 00/ 152/ 002 EU/ 1/ 00/ 152/ 003 EU/ 1/ 00/ 152/ 004 EU/ 1/ 00/ 152/ 005 EU/ 1/ 00/ 152/ 006 EU/ 1/ 00/ 152/ 007
23 October 2000 Date of latest renewal:
23 ta ’ Ottubru 2000 Data ta ’ l- aħħar tiġdid:
23 October 2005
23 ta ’ Ottubru 2005
Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus type b (Hib) conjugate vaccine (adsorbed).
Vaċċin (adsorbit) konjugat tad- difterite (D), tetnu (T), sogħla konvulsiva (komponent aċellulari), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV), u Haemophilus ta’ tip B (Hib).
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis antigens
Toxoid tad- Difterite1
not not
mhux anqas minn 30 IU
less than 30 IU less than 40 IU
mhux anqas minn 40 IU
Pertussis toxoid1 Filamentous Haemagglutinin1 Pertactin1 Hepatitis B surface antigen2,3 Poliovirus (inactivated)
Toxoid tal- Pertussis1 Filamentous Haemagglutinin1 Pertactin1 Antiġen tas- superfiċje ta ’ l- epatite B2, 3 Poliovirus (inattivat)
type 1 (Mahoney strain) 4 type 2 (MEF-1 strain) 4 type 3 (Saukett strain) 4
tip 1 (tar- razza Mahoney) 4 tip 2 (tar- razza MEF- 1) 4 tip 3( tar- razza Saukett) 4 Haemophilus tip b polysaccharide (polyribosylribitol phosphate) 3
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 10 mikrogrammi
adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 2
adsorbit fuq aluminium oxide hydrated (Al (OH) 3 2
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3 adsorbed on aluminium phosphate (AlPO4) 4 propagated in VERO cells
manifatturat fuq ċelloli ta`ħmira (Saccharomyces cerevisiae) b’ teknoloġija rekombinanti tad- DNA 3 adsorbit fuq aluminium phosphate (AlPO4) 4 propogati f’ ċelloli VERO
For a full list of excipients, see section 6.1.
Għall- lista sħiha ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension.
Is- suspensjoni tad- difterite, tetnu, pertussis aċellulari, epatite B, poljomelite inattivat (DTPa- HBV- IPV) hija bajda u mdardra.
4.2 Posology and method of administration
12 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Primary vaccination:
Tilqim primarju:
11 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).
2, 4, 6 xhur:
Booster doses should be given in accordance with the official recommendations, but, as a minimum, a dose of Hib conjugate vaccine must be administered.
Dożi booster għandhom jingħataw skond ir- rakkomandazzjonijiet uffiċjali, bħala minimu, għandha tingħata doża tal- vaċċin konġugat tal- Hib.
As with other vaccines, administration of Infanrix hexa should be postponed in subjects suffering from acute severe febrile illness.
Bħal kull vaċċin ieħor l- użu ta` Infanrix hexa m`għandux jitkompla f`individwi li jbgħatu min mard bħal mard b’ deni għoli u akut.
4.4 Special warnings and precautions for use
13 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
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 tal- pertussis, wieħed għandu jikkunsidra bir- reqqa jekk għandhomx jingħataw dożi oħra tal - vaċċin tal- pertussis.
12 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.
Limited data in 169 premature infants indicate that Infanrix hexa can be given to premature children.
14 Data limitata f’ 169 trabi prematuri uriet li Infanrix hexa tista ’ tingħata lil tfal prematuri.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Ir- riskju potenzjali ta ’ waqfien tan- nifs għal xi ħin u l- bżonn ta ’ monitoraġġ respiratorju għal 48- 72 siegħa, għandhom jiġu kkunsidrati meta l- kors ta ’ tilqim primarju jingħata lit- trabi mwieldin ħafna qabel iż- żmien (twieldu ≤ 28 ġimgħa ta ’ tqala) u speċjalment f’ dawk li diġà kellhom immaturità respiratorja.
13 There are insufficient data with regard to the efficacy and safety of simultaneous administration of Infanrix hexa and Measles-Mumps-Rubella vaccine to allow any recommendation to be made.
M’ hemmx informazzjoni biżżejjed dwar is- sigurta ’ u l- effikaċja ta ’ Infanrix hexa meta tingħata fl - istess ħin mat- tilqim tal- Ħożba- Gattone- Rubella biex tista ’ ssir xi rakkomandazzjoni.
Data on concomitant administration of Infanrix hexa with Prevenar (pneumococcal saccharide conjugated vaccine, adsorbed) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.
L- informazzjoni li hemm dwar l- użu ta ’ Infanrix hexa flimkien ma ’ Prevenar (vaċċin konjugat adsorbit ta ’ pneumococcal saccharide) ma wrew l- ebda interferenza ta ’ rilevanza klinika fir- rispons ta ’ l- anti- korpi għal kull antiġen individwali meta jingħata bħala tilqima primarja ta ’ tlett dożi.
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, huwa mistenni li f`pazjenti li qed jirċievu terapija immuno- soppressiva jista ’ ma jitlaħaqx ir- rispons adegwat.
As Infanrix hexa is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Peress li Infanrix hexa mhux intenzzjonat għal użu fl- adulti, ma teżisti l- ebda informazzjoni dwar l - użu tal- vaċċin waqt it- tqala jew treddigħ u m`hemm l- ebda studju adegwat fuq l- effett tal- vaċċin fuq ir - riproduzzjoni ta ’ l- annimali
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix hexa with respect to the primary course.
Bħal ma ’ ġie osservat bil- vaċċin DTPa u vaċċini kombinati li fihom DTPa, meta ngħatat vaċċinazzjoni booster b’ Infanrix hexa, ġiet rapportata żjieda f`rejatoġeniċita ’ lokali u deni meta mqabbla mal- kors primarju; għalkemm l- inċidenza ta ’ sintomi meqjusa bħala severi kienet baxxa.
Tabulated summary of adverse reactions (clinical trials):
Reazzjonijiet mhux mixtieqa mqassra f’ tabella (provi kliniċi):
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma ppreżentati f’ ordni ta ’ l- aktar serji l- ewwel
Frequencies per dose are defined as follows:
15 Il- frekwenzi għal kull doża huma definiti kif jidher hawn taħt:
(≥ 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)
Uncommon: somnolence Very rare: convulsions (with or without fever)
Mhux komuni: ngħas Rari ħafna: aċċessjonijiet (bi jew mingħajr deni)
Respiratory, thoracic and mediastinal disorders Uncommon: cough
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: sogħla
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)]
Skin and subcutaneous tissue disorders Angioedema
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Anġjoedema
* 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.
16 * Fi tfal li ngħataw qabel vaċċini kontra s- sogħla konvulsiva aċellulari hemm iżjed ċanż li jiżviluppaw reazzjonijiet ta ’ nefħa wara t- tilqim booster meta mqabbla ma ’ tfal li ngħataw qabel vaċċini ta ’ ċellula sħiħa.
• Experience with hepatitis B vaccine:
• Esperjenza b`vaċċin ta ’ l- epatite B
5.1 Pharmacodynamic properties
5. 1 Tagħrif Farmakodinamiku
96.3
97. 8
97.8 99.3 98.9
99. 3 98. 9
100.0 99.7 99.7
99. 7 99. 7
91.7
96. 4
96.4 96.6 96.8
96. 6 96. 8 17
16 Percentage of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Infanrix hexa
Persentaġġ ta ’ suġġetti b’ livelli ta ’ antikorpi ≥ analiżi cut- off xahar wara vaċċinazzjoni booster b’ Infanrix hexa
† cut-off accepted as indicative of protection
† cut- off aċċettata bħala indikazzjoni ta ’ protezzjoni
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 tal- pertussis ta ’ Infanrix kif deskritta mill- WHO (≥ 21 ġurnata ta` attakki ta ’ sogħla) ġiet osservata fi:
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 l- kors komplut ta` tlqim primarju mingħajr ma tingħata doża booster ta` pertussis.
This suggests that a second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously been vaccinated following this particular schedule.
18 vaċċin ta ’ pertussis hija ġġustifikata fi tfal ta ’ bejn il- 5- 7 snin li qabel kienu imlaqqmin skond din l - iskeda partikolari.
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 Infanrix hexa.
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 hexa.
17 The effectiveness of the Hib component of Infanrix hexa has been, and continues to be, investigated via an extensive post-marketing surveillance study conducted in Germany.
L- effett tal- komponent Hib ta ’ Infanrix hexa ġie u għadu qed jiġi nvestigat permezz ta ’ studju estensiv, dwar il- prodott wara li tpoġġa fuq is- suq, li sar fil- Ġermanja.
Over a five year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines, of which one was Infanrix hexa, was 90.4% for a full primary series and 100% for a booster dose (irrespective of priming).
Fuq perjodu ta ’ ħames snin wara it - teħid, l- effettivita ’ tal- komponenti tal- Hib ta ’ żewġ tilqimiet eżavalenti, fejn waħda minnhom kienet Infanrix hexa, kienet ta ’ 90. 4% għal kors primarju sħiħ u 100% għal doża booster (irrispettivament minn priming)..
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 m’ hijiex klinika magħmula fuq studji konvenzjonali dwar is- sigurta farmakoloġika, efett tossiku speċifiku, effett tossiku minn dożi repetuti, kompatibilita ’ ta ’ l- ingredjenti ma wrew l - ebda periklu speċjali għal bnedmin.
Lactose anhydrous
Trab tal- Hib Lactose anhydrous
However the stability has been demonstrated for 8 hours at 21°C after reconstitution.
Madanakollu, ntwera li jibqa tajjeb għal 8 sigħat wara li jiġi rikostitwit, f’ temperatura ta ’ + 21°C.
6.5 Nature and contents of container
19 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Powder in a vial (type I glass) with Bioset® with a stopper (butyl).
Trab ġo kunjett (ħġieġ tat- tip I) bil- Bioset® b’ tappijiet (butyl).
0.5 ml of suspension in pre-filled syringe (type I glass) with plunger stoppers (butyl).
Suspensjoni għall- injezzjoni f`siringa mimlija lesta (ħġieġ tat- tip I) (0. 5 ml) b’ tappijiet għall- planġer (butyl).
18 Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għall- immaniġġjar ieħor
This does not constitute a sign of deterioration.
Dan ma jfissirx lil- prodott qiegħed jiħżien.
The vaccine is reconstituted by adding the contents of the syringe to the vial containing the Hib powder.
Il- vaċċin jiġi rikostitwit billi żzid il- kontenut tas- siringa fil- kunjett li fiha t- trab tal- HIB.
It is good clinical practice to only inject a vaccine when it has reached room temperature.
Skond prattika medika xierqa, il- vaċċin għandu jiġi injettat biss meta t- temperatura tiegħu tkun laħqet it- temperatura tal- kamra.
In addition, a vial at room temperature ensures sufficient elasticity of the rubber closure to minimise any coring of rubber particles.
Barra minn hekk f ’ temperatura tal- kamra, l - elastiċita ’ tat- tapp tal- lastiku tal- kunjett tkun aħjar u din tnaqqas il- possibilita ’ ta ’ tifrik tal- lastiku.
To achieve this, the vial should be kept at room temperature (25 ± 3 °C) for at least five minutes before connecting the syringe and reconstituting the vaccine.
Ghal din ir- raġuni, il- kunjett għandha tinżamm f’ temperatura tal- kamra (25 ± 3 °C) għal ta ’ l- anqas ħames minuti, qabel ma ’ titwaħħal is- siringa u qabel ma ’ l- vaċċin jiġi rikostitwit.
For reconstitution, twist and remove the plastic cover from the Bioset® and remove the cap from the syringe.
Għar- rikostituzzjoni, dawwar u neħħi l- għatu tal- Bioset® u neħħi it- tapp minn mas- siringa.
Before connecting the syringe onto the Bioset®, make sure the two containers are aligned (see Picture 1).
Qabel ma ’ s- siringa titwaħħal mal- Bioset®, kun żgur li ż- żewġ kontenituri jkunu f’ linja waħda (ara l- istampa 1).
Connect the syringe onto the Bioset® by twisting it.
Waħħal is- siringa mal- Bioset® billi ddawwarha.
Inject the contents of the syringe into the vial.
Mbotta s- siringa l- isfel sakemm tisma ‘ klikk ’ li tindika li s- siringa qiegħda f’ posta.
Mix thoroughly until the Hib powder is completely dissolved.
Injetta il- kontenut tas- siringa fil- kunjett u ħawwad sew sakemm it- trab jinħall kompletament.
Aspirate the reconstituted vaccine back into the syringe.
Iġbed lura l - vaċċin rikostitwit ġewwa s- siringa.
Unscrew the syringe from Bioset® and affix a needle for vaccine administration.
Waħħal il- labra għall- injezzjoni bil- vaċċin.