qanastek/EMEA-V3 huggingface dataset:
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Imbagħad, is- sistema immunitarja tkun tista ’ tipproduċi antikorpi aktar malajr meta l- persuna tkun esposta b’ mod naturali għall- batterji jew virusijiet.
This helps to protect against the diseases that these bacteria and viruses cause.
Dan jgħin biex jipproteġi kontra l- mard ikkaġunat minn dawn il- batterji u virusijiet.
The vaccine is ‘ adsorbed’.
Il- vaċċin huwa ‘ adsorbit ’.
This means that the active substances are fixed on aluminium compounds,
Dan ifisser li s- sustanzi attivi huma mwaħħlin fuq taħlititiet ta ’ l- aluminju,
ed to stimulate a better immune response.
at biex jistimolaw reazzjoni immunitarja aħjar.
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 tal- wiċċ tal- virus ta ’ l- epatite B huma magħmulin permezz ta ’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: huma
ris The active substances in Quintanrix have been available in the European Union (EU) for a number of years in other vaccines: diphtheria, tetanus, pertussis and hepatitis B, has been available in Tritanrix HepB since 1996.
zz magħmulin minn ħmira li rċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini.
These active substances were also available in other vaccines before that date.
Is- sustanzi attivi fi Quintanrix ilhom disponibbli fl- Unjoni Ewropea (UE) għal bosta snin f’ vaċċini oħrajn: difterite, tetnu, pertussi u epatite B, ilhom disponibbli fi Tritanrix HepB sa mill- 1996.
The
Dawn is -
tho Hib component has also been available in other vaccines.
Il- komponent Hib kien ukoll disponibbli f’ vaċċini oħrajn.
How has Quintanrix been studied?
t Kif ġie studjat Quintanrix?
au The effects of Quintanrix have been studied in five main studies involving over 2,000 infants.
aw L- effetti ta ’ Quintanrix ġew studjati f’ ħames studji ewlenin li nvolvew aktar minn 2, 000 tarbija.
In three studies, the effects of Quintarix were compared with those of the combination of Tritanrix HepB and a vaccine containing Hib: two of these studies involved a total of 1,208 infants who were vaccinated at two, four and six months of age and one involved 294 infants vaccinated at three, four and five months
Fi tliet studji, l- effetti ta ’ Quintarix tqabblu ma ’ dawk tal- kumbinazzjoni ta ’ Tritanrix HepB u vaċċin li fih Hib: tnejn minn dawn l- istudji involvew total ta ’ 1, 208 trabi li kienu mlaqqmin fl- età ta ’ xahrejn, erba ’ u sitt xhur u wieħed li involva 294 tarbija imlaqqmin fl- età ta ’ tliet, erba ’ u ħames xhur.
r of age.
Ir- raba ’ studju qabbel
ge infants who either had or had not received a hepatitis B vaccine at birth.
ux l- effetti ta ’ Quintarix mogħti fl- età ta ’ 6, 10 u 14- il ġimgħa fi 318- il tarbija li jew kienu rċievew jew ma kinux irċievew vaċċin kontra l- epatite B mat- twelid.
The fifth study looked at the effects of a fourth, booster dose of Quintanrix in the second year of life in 357 infants.
Il- ħames studju ħares lejn l- effetti ta ’ raba ’, doża buster ta ’ Quintanrix fit- tieni sena ta ’ ħajja fi 357 tarbija.
In all of the studies, the main measure of effectiveness was the production of protective levels of antibodies after lon the final vaccination.
F’ dawn l- istudji kollha, il- miżura ewlenija ta ’ l -
What benefit has Quintanrix shown during the studies?
ad effettività kienet il- produzzjoni ta ’ livelli ta ’ protezzjoni ta ’ antikorpi wara l- aħħar tilqima.
Quintarix was as effective as the two separate vaccines at producing protective levels of antibodies.
Liema benefiċċju wera Quintanrix waqt l- istudji mwettqa? ’ g ħ Quintarix kien effettiv daqs iż- żewġ vaċċini separati fil- produzzjoni ta ’ livelli ta ’ protezzjoni ta ’ antikorpi.
Overall, between 95 and 100% of the infants had protective levels of antibodies to diphtheria, tetanus, no
B’ mod ġenerali, bejn 95 u 100% tat- trabi kellhom livelli ta ’ protezzjoni ta ’ antikorpi għal difterite, tetnu, pertussi, epatite B u Hib, xahar wara l- ewwel kors ta ’ tilqim.
pertussis, hepatitis B and Hib, one month after the first vaccination course.
Ma kien hemm l- ebda impatt ta ’ tilqim preċedenti kontra l- epatite B ta ’ qabel fuq l- effettività ta ’ Quintanrix. im
The study of booster vaccination also showed Quintanrix was as effective as the two separate vaccines, with between 92 and 100% of the infants having protective levels of antibodies 42 days after t uc
L- istudju ta ’ tilqima buster wera wkoll li Quintanrix kien effettiv daqs żewġ vaċċini separati, b’ bejn 92 u 100% tat- trabi ikollhom livelli ta ’ protezzjoni ta ’ antikorpi 42 jum wara t- tilqima buster. li l
What is the risk associated with Quintanrix? rod
X’ inhu r- riskju assoċjat ma ’ Quintanrix?
The most common side effects with Quintanrix (seen in more than 1 in 10 doses of the vaccine) are irritability, drowsiness, loss of appetite, pain, redness and swelling, and fever.
L- aktar effetti sekondarji komuni bi Quintanrix (jidhru f’ aktar minn doża 1 minn kull 10 tal- vaċċin) huma l- irritabbiltà, ħedla, telf ta ’ aptit, uġigħ, ħmura u nefħa, u deni.
For the full list of side effects reported with Quintanrix, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti ina
substances or any of the other ingredients.
sekondarji rrapportati ma ’ Quintanrix, ara l- Fuljett ta ’ Tagħrif.
It should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis.
Quintanrix m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal xi sustanza attiva tiegħu jew għal xi sustanza oħra tiegħu.
Quintanrix should be postponed in people with a severe sudden fever. na
Ma għandux jingħata jekk it- tifel jew tifla kellu/ ha enċefalopatija (marda tal- moħħ) ta ’ kaġun mhux magħruf fi żmien sebat ijiem mit- tilqima ta ’ qabel b’ vaċċin li kien fih diċ
As for all vaccines, if Quintanrix is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Quintanrix għandu jiġi pospost f’ nies b’ deni qawwi ħesrem.
Their breathing should be monitored for up to three days after vaccination. i dic
Bħal fil- każ tal- vaċċini kollha, jekk Quintanrix jintuża fi trabi prematuri ħafna, hemm ir- riskju li t - trabi jesperjenzaw apneja (waqfiet qosra fit- teħid tan- nifs).
Why has Quintanrix been approved?
Għaliex ġie approvat Quintanrix?
The Committee for Medicinal Products for Human Use (CHMP) decided that Quintanrix’ s benefits are greater than its risks for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Hib and for booster Me
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Quintanrix huma ikbar mir- riskji tiegħu għal tilqim primarju ta ’ trabi (matul l- ewwel sena ta ’ ħajja) ott
immunisation of young children during the second year of life.
kontra difterite, tetnu, pertussi, epatite B u mard invażiv ikkaġunat minn Hib u għal tilqim buster ta ’ tfal żgħar waqt it- tieni sena ta ’ ħajja.
The Committee recommended that Quintanrix be given marketing authorisation.
Il- Kumitat irrakkomanda li Quintanrix jingħata awtorizzazzjoni għat- tqegħid fis- suq. od
Other information about Quintanrix:
Informazzjoni oħra dwar Quintanrix:
The European Commission granted a marketing authorisation valid throughout the EU for Quintanrix to GlaxoSmithKline Biologicals s. a. on 21 October 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq valida madwar l- Unjoni Pr
2/ 3 The full EPAR for Quintanrix can be found here.
Ewropea, għal Quintanrix lil GlaxoSmithKline Biologicals s. a fil- 21 ta ’ Ottubru 2004.
This summary was last updated in 04-2008.
L- EPAR sħiħ għal Quintanrix jista ’ jiġi konsultat hawnhekk.
ed ris tho aur ge lon
Dan is- sommarju ġie aġġornat l- aħħar fi 04- 2008.
ed ris tho r au ANNEX Ige lon SUMMARY OF PRODUCT CHARACTERISTICS t no uc rod lP nai dic Me
at zz ori t aw ux ad ANNESS I ’ g ħ KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR im li l ina diċ me ott od Pr
Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
Quintanrix trab u suspensjoni għal suspensjoni għall- injezzjoni Vaċċin (adsorbit) tad- difterite, tetnu, pertussis (ċellula sħiħa), epatite B (rDNA) u Haemophilus tat -
ed 2.
zz 2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ori Wara r- rikostituzzjoni, doża 1 (0. 5 ml) jkun fiha:
ris After reconstitution, 1 dose (0.5 ml) contains:
mhux anqas minn 60 Unitajiet Internazzjonali
tho Diphtheria toxoid1 Tetanus toxoid1 Inactivated Bordetella pertussis 2 Hepatitis B surface antigen (rDNA) 2, 3
2, 3
not less than 30 International Units not less than 60 International Units not less than 4 International Units 10 micrograms
mhux anqas minn 4 Unitajiet Internazzjonali
au Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 2
Polysaccharide Haemophilus influenzae tat- tip b (polyribosylribitol phosphate) 2
2.5 micrograms
2. 5 mikrogrammi
conjugated to tetanus toxoid as a carrier
ux konjugat ma ’ toxoid tat- tetnu bħala ġarrier 1
5-10 micrograms
5- 10 mikrogrammi
ge adsorbed on aluminium hydroxide, hydrated 2 3
0. 26 milligrammi Al3+ adsorbit fuq aluminium hydroxide, idratat
Total:
ad 2 Total:
produced in Saccharomyces cerevisae cells by recombinant DNA technology lon For excipients, see section 6.1.
0. 40 milligrammi Al3+ adsorbit fuq aluminium phosphate 3 manifatturat f’ ċelluli ta ’ Saccharomyces cerevisae b’ teknoloġija rikombinanti tad- DNA ’ g ħ Għal sustanzi mhux attivi, ara sezzjoni 6. 1.
PHARMACEUTICAL FORM no
GĦAMLA FARMAĊEWTIKA im
Powder and suspension for suspension for injection The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension. t
Trab u suspensjoni għal suspensjoni għall- injezzjoni Il- komponent likwidu tad- difterite, tetnu, pertussis (ċellula sħiħa), u epatite B (DTPw- HBV) huwa li l
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder. uc rod
Il- komponent lajofilizzat tal- Haemophilus influenzae tat- tip b (HIB) huwa trab abjad. ina
4.1 Therapeutic indications lP
4. 1 Indikazzjonijiet terapewtiċi diċ
Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life. na
Quintanrix huwa indikat għat- tilqim primarju tat- trabi (fl- età ta ’ sena) kontra id- difterite, it- tetnu, il - pertussis, l- epatite B u mard invażiv ikkawżat mill- Haemophilus influenzae tat- tip b u għat- tilqim ta ’ me
The use of Quintanrix should be determined on the basis of official recommendations.
L- użu ta ’ Quintanrix għandu jiġi determinat fuq il- bażi ta ’ rakkommandazzjonijiet uffiċjali.
4.2 Posology and method of administration i dic
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata ott
Posology
Pożoloġija od
Me
L- iskeda ta ’ tilqim primarju tikkonsisti fi tliet dożi ta ’ 0. 5ml li għandhom jingħataw f’ intervalli ta ’ Pr
The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations.
mill- anqas 4 ġimgħat sa l- età ta ’ sitt xhur skond ir- rakkommandazzjonijiet uffiċjali lokali.
The first dose can be administered at 6 weeks of age.
L- ewwel doża tista ’ tingħata fl- eta ’ ta ’ sitt ġimgħat.
The following schedules have been studied in clinical trials:
L- iskedi li ġejjin kienu studjati fi provi kliniċi:
2-4-6 months, 3-4-5 months and 6-10-14 weeks.
2- 4- 6 xhur, 3- 4- 5 xhur u 6- 10- 14- il ġimgħa.
The 3-5-12 month schedule was not evaluated.
L- iskeda ta ’ 3- 5- 12- il xahar ma kinetx evalwata.
2 Quintanrix can be given to children who have received hepatitis B vaccine at birth.
Quintanrix jista ’ jingħata lit- tfal li rċievew il- vaċċin ta ’ l- epatite B mat- twelid.
The immunoprophylactic measures for hepatitis B should not be modified for children born to hepatitis B virus carrying mothers.
2 Il- miżuri immunoprofilattiċi għall- epatite B m’ għandhomx jiġu modifikati għat- tfal li twieldu minn ommijiet li jġorru il- virus ta ’ l- epatite B.
This may require separate administration of hepatitis B vaccine and should follow official recommendations.
Dan jista ’ jinħtieg l- amministrazzjoni separata ta ’ vaċċin ta ’ l- epatite B u għandu jsegwi rakkommandazzjonijiet uffiċjali.
ed Booster vaccination:
at Tilqim ta ’ rinforz:
After the completion of the primary series, a booster should be administered preferably before the
zz Wara t- tmiem tas- sensiela ta ’ tilqim primarju, għandu jiġi amministrat rinforz preferibbilment qabel mat- tarbija tagħlaq sentejn.
Booster administration should be in accordance with official recommendations.
L- amministrazzjoni ta ’ rinforz għandha tkun skond ir - rakkommandazzjonijiet uffiċjali.
tho Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in accordance with official recommendations for boosting.
Id- doża ta ’ rinforz għandha
The booster dose should preferably be given at least 6 months after the last primary dose.
t preferibbilment tingħata mill- anqas 6 xhur wara l- aħħar doża primarja.
au Method of administration
aw Kif għandu jingħata
Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.
Quintanrix qiegħed għal injezzjoni fil- fond ġol- muskolu, preferibbilment ġol- koxxa anterolaterali.
r ge 4.3 Contraindications
ux 4. 3 Kontra- indikazzjonijiet
Hypersensitivity to the active substances or to any of the excipients. lon Quintanrix is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Quintanrix huwa kontra- indikat jekk it- tifel/ tifla kellu/ ha enċefalopatija li l- kawża tagħha ma kinetx ’ g ħ magħrufa, u li tkun seħħet fi żmien 7 ijiem minn tilqim preċedenti b’ vaċċin li kien fih il- pertussis.
In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines. no
F’ dawn iċ- ċirkustanzi l- kors ta ’ tilqim għandu jitkompla b’ vaċċini tad- difterite, tat- tetnu, ta ’ l- epatite B u tal- HIB. im
As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering from acute severe febrile illness.
Bħal f’ vaċċini oħra, l- amministrazzjoni ta ’ Quintanrix għandha tiġi posposta f’ suġġetti li qed ibatu minn mard b’ deni akut u serju.
The presence of a minor infection, such as a cold, is not a contraindication for vaccination. t uc
Il- preżenza ta ’ infezzjoni ħafifa, bħal riħ, m’ hijiex kontra - indikazzjoni għat- tilqim. li l
4.4 Special warnings and special precautions for use rod
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu ina
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).
It- tilqim għandu jingħata wara analizi ta ’ l- istorja medika (speċjalment fir- rigward ta ’ tilqim preċedenti li seta ’ kellu effetti mhux mixtieqa).
As with all injectable vaccines, appropriate medical treatment and supervision should always be lP
Bħal fil- każ tal- vaċċini l- oħra kollha li jiġu injettati, kura u sorveljanza medika xierqa għandhom diċ
readily available in case of a rare anaphylactic event following the administration of the vaccine.
dejjem ikunu disponibbli fil- każ rari ta ’ ġrajja anafilattika li tista ’ tinqala ’ wara l- amministrazzjoni tal- vaċċin.
For this reason, the vaccinee should remain under medical supervision for at least 30 minutes.
Għal din ir- raġuni min qed jiġi mlaqqam għandu jibqa ’ taħt sorveljanza medika għal mill - anqas 30 minuta. me
If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give na
Jekk kwalunkwe waħda minn dawn il- ġrajjiet li ġejjin tiġri fl- istess żmien meta jittieħed Quintanrix, għandu jiġi kkunsidrat bir- reqqa jekk għandhomx jingħataw id- dożi li jkun imiss tal- vaċċin li fih il - komponent tal- pertussis: • Temperatura ≥ 40. 0 °C fi żmien 48 siegħa, mhux minħabba kawża oħra magħrufa. ott
subsequent doses of a vaccine containing the pertussis component should be carefully considered: • Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause. • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours. i dic
• Kollass jew stat bħal f’ xokk (episodju ipotoniku- iporisponsiv) fi żmien 48 siegħa. • Biki persistenti li jdum ≥ 3 sigħat, li jiġri fi żmien 48 siegħa. • Aċċessjonijiet bid- deni jew mingħajr deni li jiġru fi żmien tlett ijiem. od
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Jista ’ jkun hemm ċirkustanzi, bħal per eżempju inċidenza għolja ta ’ pertussis, meta l- benefiċċji jkunu akbar mir- riskji possibbli.
Quintanrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Quintanrix għandu jingħata b’ attenzjoni lil suġġetti b’ tromboċitopenja jew xi disturb tal- fsada minħabba li f’ dawn is- suġġetti jista ’ jkun hemm fsada wara li tingħata t- tilqima ġol- muskolu.
A fine needle can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least two minutes following administration.
Tista ’ tintuża labra rqiqa għat- tilqim u s- sit jingħafas b’ mod sod (mingħajr ma jingħorok) għal mill- anqas żewġ minuti wara l- amministrazzjoni.
Quintanrix should under no circumstances be administered intravascularly.
3 Quintanrix m’ għandu qatt jingħata taћt l- ebda ċirkostanza b’ mod intravaskulari.
3 The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.
Il- vaċċin ma ’ jilqax kontra infezzjonijiet ikkawżati minn patoġeni oħra magħrufa li jinfettaw il- fwied bħal ma ’ huma l- viruses ta ’ l- epatite A, l- epatite C u l- epatite E.
The HIB component of the vaccine does not protect against diseases due to capsular serotypes other than type b of Haemophilus influenzae or against meningitis caused by other organisms.
at Il- komponent tal- HIB tal- vaċċin ma jipproteġix kontra mard permezz ta ’ serotipi kapsulari oħra ħlief dawk tat- tip b tal- Haemophilus influenzae jew kontra meninġite ikkawżata minn organiżmi oħrajn.
ed 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 Quintanrix.
zz Storja ta ’ aċċessjonijiet bid- deni, storja fil- familja ta ’ konvulżjonijiet jew is- Sindrome ta ’ Mewt f’ Daqqa fit- Trabi (SIDS) m’ humiex ta ’ kontra- indikazzjoni għall- użu ta ’ Quintanrix.
Vaccinees with a history of
Dawk li se
ris febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
ori jirċievu t- tilqima u għandhom storja ta ’ aċċessjonijiet tad- deni għandhom ikomplu jiġu segwiti mill - qrib minħabba li reazzjonjiet avversi bħal dawn jistgħu jseħħu fi żmien 2 sa 3 ijiem wara t- tilqim.
tho HIV infection is not considered as a contraindication.
t Infezzjoni ta ’ l- HIV m’ hijiex meqjusa bħala kontra- indikazzjoni.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Ir- rispons immunoloġiku jista ’ ma ’
Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be
Testijiet oħra għandhom isiru
Other tests should be performed in order to confirm HIB infection during this period.
ux biex jikkonfemaw infezzjoni bl- HIB waqt dan il- perjodu.
r ge The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. lon As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed. no
ad 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 ’ g ħ qabel iż- żmien (twieldu ≤ 28 ġimgħa ta ’ tqala) u speċjalment f’ dawk li diġà kellhom immaturità respiratorja.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti medicinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu li l
In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate injection sites, during the same session. t uc
Fit- tilqim pedjatriku hija prattika frekwenti li vaċċini differenti li jiġu injettati jingħataw flimkien f’ siti ina
Limited data show that there is no interference with the response to Measles-Mumps-Rubella (MMR) and OPV antigens.
ta ’ injezzjoni separati fl- istess sessjoni.
Although no data are available on the immune response to the Bacille-Calmette- rod
Għalkemm l- ebda tagħrif m’ hu disponibbli dwar ir- rispons immuni diċ
Guérin (BCG) antigen, no interference is expected.
għall- antiġen Bacille- Calmette- Guérin (BCG), ma hija mistennija l- ebda interferenza.
As with other vaccines it may be expected that an adequate response may not be achieved in patients receiving immunosuppressive therapy or patients with immunodeficiency. lP
Bħal fil- każ ta ’ vaċċini oħra, huwa mistenni li rispons adegwat jista ’ ma jinkisibx f’ pazjenti li qed me
As Quintanrix is not intended for use in adults, information on the safety of the vaccine when used na
Minħbba li Quintanrix m’ huwiex intenzjonat li jintuża fl- adulti, informazzjoni dwar is- sigurtà tal - ott
during pregnancy or lactation is not available.
vaċċin meta użat waqt it- tqala jew treddiegħ m’ hijiex disponibbli.
4.7 Effects on ability to drive and use machines i dic
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni od
4.8 Undesirable effects Me
4. 8 Effetti mhux mixtieqa
Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.
Quintanrix kien amministrat lil bejn wieħed u ieħor 1, 340 tarbija b’ saħħita mill- età ta ’ 6 ġimgħat bħala kors ta ’ tilqim primarju f’ diversi provi kliniċi.
In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) and irritability, which were associated with about 50% of the doses administered.
4 F’ dawn il- provi l- aktar reazzjonijiet komuni li seħħew wara l- amministrazzjoni tal- vaċċin kienu uġigħ fis- sit ta ’ l- injezzjoni, deni (taħt l- abt ≥ 37. 5°C; fir- rektum ≥ 38°C) u irritabilità, li kienu assoċjati ma ’ madwar 50% tad- dożi amministrati.
4 Adverse reactions are listed below.
Reazzjonijiet avversi huma elenkati hawn taħt.
Frequencies are reported as:
at Il- fekwenzi huma rrappurtati bħala:
Very common:
zz Komuni ħafna:
(> 1/ 10) (> 1/ 100, < 1/ 10)
(> 1/ 10) (> 1/ 100, < 1/ 10) (> 1/ 1, 000, < 1/ 100)
Rare:
ori Rari:
(> 1/ 1,000 ,< 1/100) (> 1/10 ,000, < 1/1,000) (< 1/ 10,000) including isolated reports
(> 1/ 10, 000, < 1/ 1, 000) (< 1/ 10, 000) inkluż rapporti iżolati
ris Psychiatric disorders: very common: irritability
aw komuni ħafna: irritabbiltà
tho Nervous system disorders: very common: drowsiness rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions
Disturbi fis- sistema nervuża: komuni ħafna: ngħas
au Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing
ad rari: bronkite, sogħla
r ge Gastrointestinal disorders: very common: loss of appetite rare: vomiting lon General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C) no
komuni ħafna: uġigħ, ħmura u nefħa, deni (taħt l- abt ≥ 37. 5°C; fir- rektum ≥ 38°C) komuni: ebusija, deni (taħt l- abt ≥ 37. 5°C; fir- rektum ≥ 38°C) li l
Quintanrix was administered as a booster to 435 infants in the second year of life.
Quintanrix ġie amministrat bħala rinforz lil 435 tarbija fl- età ta ’ sentejn.
As shown with other vaccines, the booster dose is potentially associated with an increased incidence of minor adverse events such as fever and local reactions. t
Kif intwera b’ vaċċini oħra, id- doża ta ’ rinforz hija potenzjalment assoċjata ma ’ inċidenza ogħla ta ’ effetti avversi ħfief bħal deni u reazzjonijiet lokali. ina
Adverse reactions reported after booster vaccination are listed below. uc
Reazzjonijiet avversi rrappurtati wara tilqim ta ’ rinforz huma elenkati hawn taħt.
Psychiatric disorders rod
Disturbi psikjatriċi: diċ
very common: irritability
komuni ħafna: irritabbilità
Nervous system disorders: very common: drowsiness lP
komuni ħafna: ngħas
Gastrointestinal disorders: very common: loss of appetite na
Disturbi gastro- intestinali: komuni ħafna: nuqqas t’ aptit ott
General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: fever (axillary > 39°C; rectal > 39.5°C) i dic
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata: komuni ħafna: uġigħ, ħmura u nefħa, deni (taħt l- abt ≥ 37. 5°C; fir- rektum ≥ 38°C) komuni: deni (taħt l- abt ≥ 37. 5°C; fir- rektum ≥ 38°C) od
uncommon: induration
mhux komuni: ebusija
Allergic reactions, including anaphylactoid reactions and urticaria, have been reported very rarely following vaccination with DTP, hepatitis B and HIB containing vaccines.
Reazzjonijiet allerġiċi, inkluż reazzjonijiet anafilattiċi u urtikarja kienu rrappurtati rari ħafna wara Pr
Me
tilqim b’ vaċċini li kien fihom DTP, epatite B u HIB.
During post marketing surveillance studies with other hepatitis B containing vaccines, serum sickness like disease and thrombocytopenia have been reported very rarely.
Waqt studji ta ’ sorveljanza wara t- tqegħid fis- suq b’ vaċċini oħra li fihom l- epatite B, kienu rrappurtati b’ mod rari ħafna marda bħal serum sickness u tromboċitopenja.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore it is possible that sensitisation reactions may occur (see section 4.3).
5 Dan il- prodott mediċinali fih thiomersal (kompost organomerkurjali) bħala preservattiv u għalhekk huwa possibbli li jista ’ jkun hemm reazzjonijiet ta ’ sensitizzazzjoni (ara sezzjoni 4. 3).
5 Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Waqfien tan- nifs għal xi ħin fit- trabi mwieldin ħafna qabel iż- żmien (≤ 28 ġimgħa ta ’ tqala) (ara sezzjoni 4. 4)
4.9 Overdose
at 4. 9 Doza eċċessiva
No case of overdose has been reported.
zz L- ebda każ ta ’ doża eċċessiva ma kien irrappurtat.
ed 5.
ori 5.
ris Pharmaco-therapeutic group:
t Grupp farmako- terapewtiku:
Bacterial and viral vaccines combined, ATC code JO7CA10
Vaċċini batteriċi u virali kombinati, Kodiċi ATC JO7CA10
5.1 Pharmacodynamic properties
aw 5. 1 Tagħrif farmakodinamiku
tho The immune response after a three-dose primary vaccination course was evaluated in five trials:
Ir- rispons immuni wara kors ta ’ tilqim primarju ta ’ tliet dożi kien evalwat f’ ħames provi:
Results from different
297 tarbija
au studies show that, overall, 95.5% and 99.9% of subjects had anti-diphtheria and anti-tetanus titres ≥ 0.1 IU/ ml one month after completion of the primary vaccination course.
ux ġew evalwati wara tilqim fl- età ta ’ 6, 10 u 14- il ġimgħa, 685 wara tilqim fl- età ta ’ 2, 4, u 6 xhur u 107 wara tilqim fl- età ta ’ 3, 4 u 5 xhur.
At this time, the percentage of infants with anti-PRP titres ≥ 0.15 µg/ ml was > 99% and the percentage with anti-HBs titres ≥ 10
Riżultati minn studji differenti juru li b’ kollox, 95. 5% u 99. 9% tas- suġġetti kellhom titri ≥ 0. 1 IU/ ml kontra t- tetnu u kontra d- difterite xahar wara li kien
r mIU/ ml was 97.3%.
ad komplut il- kors ta ’ tilqim primarju.
More than 99% of subjects were considered to have responded to the pertussis
F’ dan iż- żmien il- persentaġġ ta ’ trabi b’ titri kontra l- PRP ≥ 0. 15 µg/ ml kien > 99% u l- persentaġġ b’ titri konta l- HB ≥ 10 mIU/ ml kien ta ’ 97. 3%.
ge component of the vaccine, which was defined as the appearance of antibodies in initially seronegative subjects (i. e. subjects with pre-vaccination titres < 15 ELU/ ml) or a post-vaccination titre at least equal to pre-vaccination levels in subjects initially seropositive due to maternally- lon derived antibodies.
Aktar minn 99% tas- suġġetti kienu kkunsidrati li rrispondew għall- komponent pertussis tal- vaċċin, li kien definit ’ g ħ bħala d- dehra ta ’ antikorpi f’ suġġetti li inizjalment kienu seronegattivi (jiġifieri suġġetti b’ titri < 15 ELU/ ml qabel it- tilqim) jew titri wara t- tilqim ta ’ lanqas daqs il- livelli ta ’ qabel it- tilqim f’ suġġetti li inizjalment kienu seropożittivi minħabba antikorpi meħuda mingħand l- omm. im
Seroprotection and vaccine response rates were similar for the three schedules used, with the exception of anti-HBs.
Seroprotezzjoni u rati ta ’ rispons għall- vaċċin kienu jixtiebħu għat- tliet skedi użati, minbarra għall - kontra l- HBs.
The seroprotection rates for anti-HBs (≥ 10 mlU/ ml) observed with the 6, 10, 14 week schedule was lower as shown in the table below, but is unlikely to be clinically relevant due no
Ir- rati ta ’ seroprotezzjoni għall- kontra l- HBs (≥10 mlU/ ml) osservati fl- iskeda tas- 6, l - 10 u l- 14- il ġimgħa kienu aktar baxxi kif muri fit- tabella hawn taħt, iżda dan x’ aktarx m’ huwiex li l
to the small sample size:
klinikamnet rilevanti minħabba d- daqs żgћir tal- kampjun:
2, 4, 6
Skeda tas- 6, l- 10 ul- 14- il
3, 4, 5
diċ
6, 10, 14 weeks schedule N = 97
ġimgħa N = 97
98.9%
98. 9%
rod
95. 3%
95.3%
92. 8%
92.8%
Teżisti informazzjoni limitata dwar il- persistenza tar- rispons immuni wara t- tilqim primarju bi me
Limited information exists on the persistence of the immune response after primary vaccination with Quintanrix as well as on the immunogenicity of booster doses.
Quintanrix kif ukoll dwar l- immunoġeniċità tad- dożi ta ’ rinforz.
Results from one pilot study showed that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to lP
Riżultati minn studju pilota wieħed urew li għal 63 tarbija imlaqqma primarjament skond l- iskeda tas- 6, l- 10 u l- 14- il ġimgħa, > 80% kien għad kellhom antikorpi għad- difterite, għat- tetnu, għall- HBs u għall- PRP f’ livelli kkunsidrati bħala protettivi.
diphtheria, tetanus, HBs and PRP at levels considered to be protective.
Wieħed u erbgħin fil- mija kellhom antikorpi għall- pertussis.
Data from clinical trials show that Quintanrix, when given as a booster dose in the second year of life, induces a greater than 10-fold increase in mean antibody titre with respect na
Tagħrif minn provi ott
It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as i
kliniċi juri li Quintanrix, meta jingħata bħala rinforz fl- età ta ’ sentejn, jinduċi tkabbir ta ’ aktar minn 10 darbiet fit- titru medju ta ’ l- antikorpi meta mqabbla mal- livelli ta ’ qabel ir- rinforz għall - komponenti kollha tal- vaċċin. od
hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. dic
Pr
5.3 Preclinical safety data
6 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
No preclinical safety testing with the vaccine has been conducted.
Ma saru l- ebda testijiet ta ’ qabel l- użu kliniku dwar is- sigurtà tal- vaċċin.
6 6.
at 6.
6.1 List of excipients
zz 6. 1 Lista ta ’ sustanzi mhux attivi
Lyophilised HIB component:
Komponent tal- HIB lajofilizzat:
Lactose
ori Lattosju
ed Liquid DTPw-HBV component:
Komponent tad- DTPw- HBV likwidu:
Thiomersal
t Thiomersal
ris Sodium chloride Water for injections.
aw Sodium chloride Ilma għall- injezzjonijiet
tho For adjuvants, see section 2.
Għal sustanzi awżiljari, ara taqsima 2.
6.2 Incompatibilities
ux 6. 2 Inkompatibilitajiet
au In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.
ad Fin- nuqqas ta ’ studji ta ’ kompatibilità, il- vaċċin Quintanrix rikostitwit m’ għandux jitħallat ma prodotti mediċinali oħra. ’ g ħ 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
r ge 3 years.
3 snin. im
After reconstitution, it is recommended to inject the vaccine promptly.
Wara li jiġi rikostitwit, huwa rakkomandat li l- vaċċin jiġi injettat immedjatament.
However the stability has been lon demonstrated for 8 hours at 25°C after reconstitution.
Madanakollu intweriet stabbiltà għal- 8 sigħat f’ temperatura ta ’ 25°C wara r- rikostituzzjoni. li l
6.4 Special precautions for storage no
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in a refrigerator (2°C – 8°C)
Aħżen fi friġġ (2°C – 8°C) ina
Do not freeze. t
Tagħmlux fil- friża.
Store in the original package in order to protect from light. uc
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl. diċ
6.5 Nature and contents of container rod
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih me
Powder in a vial (type I glass) for 1 dose with a stopper (rubber butyl).
Trab ġo fjala (ħġieġ tat- tip I) għal doża waħda b’ tapp (rubber butyl).
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in the following pack sizes: lP
0. 5 ml ta ’ suspensjoni fi fjala (ħġieġ tat- tip I) għal doża waħda b’ tapp (rubber butyl) f’ pakketti ta ’ daqsijiet li ġejjin:
- pack size of 1 vial of powder plus 1 vial of suspension
- pakkett bi fjala 1 ta ’ trab flimkien ma ’ fjala 1 ta ’ suspensjoni
- pack size of 100 vials of powder plus 100 vials of suspension
- pakkett b’ 100 fjala ta ’ trab flimkien ma ’ 100 fjala ta ’ suspensjoni
Not all pack sizes may be marketed. na
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali. od
6.6 Instructions for use and handling i dic
6. 6 Struzzjonijiet għall- użu u maniġġar
Upon storage, a white deposit and clear supernatant may be observed for the DTPw-HBV component.
Meta jinħażen, depożitu abjad u saff likwidu ċar fil- wiċċ jistgħu jiġu osservati għall- komponent Pr
This does not constitute a sign of deterioration.
Dan ma jfissirx li l- prodott ħżien.
The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white Me
Il- komponent DTPw- HBV għandu jitħawwad sewwa biex tinkiseb suspensjoni uniformi, bajda u imdardra u li għanda tiġi miflija viżwalment għal xi frak u/ jew dehra fiżika mhux normali.
suspension and should be inspected visually for any foreign particulate matter and/ or abnormal physical appearance.
7 Il- vaċċin jiġi rikostitwit billi tiġbed il- kontenut tal- fjala li fiha l- komponent DTPw- HBV permezz ta ’ siringa u żżidu mal- fjala li fiha t- trab ta ’ l- HIB.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Wara li żżid il- komponent DTPw- HBV mat- trab ta ’ l - HIB, it- taħlita għandha titħawwad sewwa sakemm it- trab jinħall kollu.
The vaccine is reconstituted by withdrawing the contents of the vial containing the DTPw-HBV component by means of a syringe and by adding it to the vial containing the HIB powder.
at Neħħi u armi l- labra li ntużat għar- rikostituzzjoni u minflokha poġġi l- labra li biha se tagħti l- vaċċin.
After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until
zz Wara r- rikostituzzjoni, il- vaċċin għandu jiġi injettat immedjatament.
7 the powder is completely dissolved.
ori 7.
The reconstituted vaccine is a homogeneous turbid white suspension.
DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine.
GlaxoSmithKline Biologicals s. a.
MARKETING AUTHORISATION HOLDER
t Rue de l' Institut 89
Rue de l'Institut 89 B-1330 Rixensart, Belgium
aw B- 1330 Rixensart, Il- Belġju
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI
au EU/ 1/ 04/ 301/ 001 EU/ 1/ 04/ 301/ 002
ux EU/ 1/ 04/ 301/ 001 EU/ 1/ 04/ 301/ 002
r ge 9.
ad 9.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TA ’ L - ’ g ħ AWTORIZZAZZJONI
DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA L- KITBA li l ina diċ me ott od Pr
Quintanrix powder and suspension for suspension for injection, multidose Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
Quintanrix trab u suspensjoni għal suspensjoni għall- injezzjoni, ħafna dożi Vaċċin (adsorbit) tad- difterite, tetnu, pertussis (ċellula sħiħa), epatite B (rDNA) u Haemophilus tat -
produced in Saccharomyces cerevisae cells by recombinant DNA technology lon This is a multidose container.
0. 40 milligrammi Al3+ adsorbit fuq aluminium phosphate 3 manifatturat f’ ċelluli ta ’ Saccharomyces cerevisae b’ teknoloġija rikombinanti tad- DNA ’ g ħ Dan huwa kontenitur b’ ħafna dożi.
See section 6.5 for the number of doses per vial.
Ara sezzjoni 6. 5 għan- numru ta’ dożi li fiha kull fjala.
For excipients, see section 6.1. no
Għal sustanzi mhux attivi, ara sezzjoni 6. 1. im
PHARMACEUTICAL FORM
GĦAMLA FARMAĊEWTIKA li l
The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid uc
Trab u suspensjoni għal suspensjoni għall- injezzjoni Il- komponent likwidu tad- difterite, tetnu, pertussis (ċellula sħiħa), u epatite B (DTPw- HBV) huwa supensjoni bajda mdardra. ina
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder. rod
Il- komponent lajofilizzat tal- Haemophilus influenzae tat- tip b (HIB) huwa trab abjad.
CLINICAL PARTICULARS lP
TAGĦRIF KLINIKU diċ
4.1 Therapeutic indications
4. 1 Indikazzjonijiet terapewtiċi me
Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae na
Quintanrix huwa indikat għat- tilqim primarju tat- trabi (fl- età ta ’ sena) kontra id- difterite, it- tetnu, il - pertussis, l- epatite B u mard invażiv ikkawżat mill- Haemophilus influenzae tat- tip b u għat- tilqim ta ’ rinforz tat- tfal żgħar fl- età ta ’ sentejn.
The use of Quintanrix should be determined on the basis of official recommendations. i dic
L- użu ta ’ Quintanrix għandu jiġi determinat fuq il- bażi ta ’ rakkommandazzjonijiet uffiċjali. ott
4.2 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata od
Posology Me
Pożoloġija
The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations.
L- iskeda ta ’ tilqim primarju tikkonsisti fi tliet dożi ta ’ 0. 5ml li għandhom jingħataw f’ intervalli ta ’ mill- anqas 4 ġimgħat sa l- età ta ’ sitt xhur skond ir- rakkommandazzjonijiet uffiċjali lokali.
The first dose can be administered at 6 weeks of age.
2- 4- 6 xhur, 3- 4- 5 xhur u 6- 10- 14- il ġimgħa.
The following schedules have been studied in
L- iskeda ta ’ 3- 5- 12- il xahar ma kinetx evalwata.
The 3-5-12 month schedule was not evaluated.
9 Quintanrix jista ’ jingħata lit- tfal li rċievew il- vaċċin ta ’ l- epatite B mat- twelid.
Quintanrix can be given to children who have received hepatitis B vaccine at birth.
Il- miżuri immunoprofilattiċi għall- epatite B m’ għandhomx jiġu modifikati għat- tfal li twieldu minn ommijiet li jġorru l- virus ta ’ l- epatite B.
The immunoprophylactic measures for hepatitis B should not be modified for children born to
Dan jista ’ jinħtieg l- amministrazzjoni separata ta ’ vaċċin ta ’
ed hepatitis B virus carrying mothers.
at l- epatite B u għandu jsegwi rakkommandazzjonijiet uffiċjali.
ris Booster vaccination:
zz Tilqim ta ’ rinforz:
After the completion of the primary series, a booster should be administered preferably before the
Wara t- tmiem tas- sensiela ta ’ tilqim primarju, għandu jiġi amministrat rinforz preferibbilment qabel
tho end of the second year of life.
ori mat- tarbija tagħlaq sentejn.
Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in
t Quintanrix jista ’ jintuża biex jirrinforza r- rispons għall- antiġeni tad- DTP, l- HBV u l- HIB jekk l -
au accordance with official recommendations for boosting.
aw għamla tiegħu tkun skond ir- rakkomandazzjonijiet uffiċjali għar- rinforz.
The booster dose should preferably be given at least 6 months after the last primary dose.
Id- doża ta ’ rinforz għandha preferibbilment tingħata mill- anqas 6 xhur wara l- aħħar doża primarja.
r ge Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.
ux Quintanrix qiegħed għal injezzjoni fil- fond ġol- muskolu, preferibbilment ġol- koxxa anterolaterali.
4.3 Contraindications lon Hypersensitivity to the active substances or to any of the excipients.
ad 4. 3 Kontra- indikazzjonijiet
occurring within 7 days following previous vaccination with pertussis containing vaccine.
Sensittività eċċessiva għas- sustanzi attivi jew għal xi wieħed mis- sustanzi mhux attivi. ’ g ħ Quintanrix huwa kontra- indikat jekk it- tifel/ tifla kellu/ ha enċefalopatija li l- kawża tagħha ma kinetx magħrufa, u li tkun seħħet fi żmien 7 ijiem minn tilqim preċedenti b’ vaċċin li kien fih il- pertussis.
In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines. t
F’ dawn iċ- ċirkustanzi l- kors ta ’ tilqim għandu jitkompla b’ vaċċini tad- difterite, tat- tetnu, ta ’ l- epatite im
As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering uc
Bħal f’ vaċċini oħra, l- amministrazzjoni ta ’ Quintanrix għandha tiġi posposta f’ suġġetti li qed ibatu li l
from acute severe febrile illness.
minn mard b’ deni akut u serju.
The presence of a minor infection, such as a cold, is not a contraindication for vaccination. rod
Il- preżenza ta ’ infezzjoni ħafifa, bħal riħ, m’ hijiex kontra - indikazzjoni għat- tilqim. ina
Vaccination should be preceded by a review of the medical history (especially with regard to lP
It- tilqim għandu jingħata wara analizi ta ’ l- istorja medika (speċjalment fir- rigward ta ’ tilqim preċedenti li seta ’ kellu effetti mhux mixtieqa). diċ
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. na
Bħal fil- każ tal- vaċċini l- oħra kollha li jiġu injettati, kura u sorveljanza medika xierqa għandhom dejjem ikunu disponibbli fil- każ rari ta ’ ġrajja anafilattika li tista ’ tinqala ’ wara l- amministrazzjoni me
For this reason, the vaccinee should remain under medical supervision for at least 30 minutes.
Għal din ir- raġuni min qed jiġi mlaqqam għandu jibqa ’ taħt sorveljanza medika għal mill - anqas 30 minuta.
If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give i dic
Jekk kwalunkwe waħda minn dawn il- ġrajjiet li ġejjin tiġri fl- istess żmien meta jittieħed Quintanrix, għandu jiġi kkunsidrat bir- reqqa jekk għandhomx jingħataw id- dożi li jkun imiss tal- vaċċin li fih il - ott
Me
komponent tal- pertussis: • Temperatura ≥ 40. 0 °C fi żmien 48 siegħa, mhux minħabba kawża oħra magħrufa. • Kollass jew stat bħal f’ xokk (episodju ipotoniku- iporisponsiv) fi żmien 48 siegħa. od
• Convulsions with or without fever, occurring within 3 days.
• Biki persistenti li jdum ≥ 3 sigħat, li jiġri fi żmien 48 siegħa. • Aċċessjonijiet bid- deni jew mingħajr deni li jiġru fi żmien tlett ijiem.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Jista ’ jkun hemm ċirkustanzi, bħal per eżempju inċidenza għolja ta ’ pertussis, meta l- benefiċċji jkunu Pr
A
Tista ’
10 fine needle can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least two minutes following administration.
10 tintuża labra rqiqa għat- tilqim u s- sit jingħafas b’ mod sod (mingħajr ma jingħorok) għal mill- anqas żewġ minuti wara l- amministrazzjoni.
Quintanrix should under no circumstances be administered intravascularly.
Quintanrix m’ għandu qatt jingħata taħt l- ebda cirkostanza b’ mod intravaskulari.
The vaccine will not prevent infection caused by other pathogens known to infect the liver such as
at Il- vaċċin ma ’ jilqax kontra infezzjonijiet ikkawżati minn patoġeni oħra magħrufa li jinfettaw il- fwied bħal ma ’ huma l- viruses ta ’ l- epatite A, l- epatite C u l- epatite E.
The HIB component of the vaccine does not protect against diseases due to capsular serotypes other
zz Il- komponent tal- HIB tal- vaċċin ma jipproteġix kontra mard permezz ta ’ serotipi kapsulari oħra ħlief dawk tat- tip b tal- Haemophilus influenzae jew kontra meninġite ikkawżata minn organiżmi oħrajn.
ris than type b of Haemophilus influenzae or against meningitis caused by other organisms.
Dawk li se
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome
t jirċievu t- tilqima u għandhom storja ta ’ aċċessjonijiet tad- deni għandhom ikomplu jiġu segwiti mill -
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.
aw qrib minħabba li reazzjonjiet avversi bħal dawn jistgħu jseħħu fi żmien 2 sa 3 ijiem wara t- tilqim.
au HIV infection is not considered as a contraindication.
Infezzjoni ta ’ l- HIV m’ hijiex meqjusa bħala kontra- indikazzjoni.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Ir- rispons immunoloġiku jista ’ ma ’ jinkisibx meta jitlaqqmu pazjenti immunosoppressi.
Other tests should be performed in order to confirm HIB infection during this period.
ad biex jikkonfemaw infezzjoni bl- HIB waqt dan il- perjodu.
Antipyretic treatment should be initiated according to local treatment guidelines. lon The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. no
Kura għal kontra d- deni għandha tinbeda skond il- linji gwida tat- trattament lokali. ’ g ħ 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 im
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed. t
Minħabba li l - vaċċinazzjoni f' dan il- grupp ta 'trabi hija ta ’ ġid kbir, t- tilqim m’ għandux jinżamm lura li l
4.5 Interaction with other medicinal products and other forms of interaction uc
jew jiġi pospost.
In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate rod
4. 5 Prodotti medicinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu ina
injection sites, during the same session.
jibdlu l- effett farmaċewtiku tal- prodott
Limited data show that there is no interference with the response to Measles-Mumps-Rubella (MMR) and OPV antigens.
Tagħrif limitat juri li m’ hemmx interferenza mar- rispons ta ’ l- antiġeni tal- Ħożba- Gattone- Rubella (MMR) u tal- vaċċin orali tal- poljo.
Although no data are available on the immune response to the Bacille-Calmette- lP
Għalkemm l- ebda tagħrif m’ hu disponibbli dwar ir- rispons immuni me