qanastek/EMEA-V3 huggingface dataset:
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. na
Bħal fil- każ ta ’ vaċċini oħra, huwa mistenni li rispons adegwat jista ’ ma jinkisibx f’ pazjenti li qed jirċievu kura immunosoppressiva jew pazjenti b’ immunodefiċjenza. ott
4.6 Pregnancy and lactation i dic
4. 6 Tqala u effetti fuq il- ħalib tas- sider
As Quintanrix is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.
Minħbba li Quintanrix m’ huwiex intenzjonat li jintuża fl- adulti, informazzjoni dwar is- sigurtà tal - od
4.7 Effects on ability to drive and use machines Me
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni Pr
Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.
11 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.
11 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.
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
Adverse reactions are listed below.
zz Reazzjonijiet avversi huma elenkati hawn taħt.
ed Frequencies are reported as:
Il- fekwenzi huma rrappurtati bħala:
Very common:
ori Komuni ħafna:
ris Common:
Komuni:
Rare:
t Rari:
(> 1/ 100 ,< 1/10) (> 1/1 ,000, < 1/100) (> 1/10,000, < 1/ 1,000)
(> 1/ 10, 000, < 1/ 1, 000)
tho Very rare:
aw Rari ħafna:
(< 1/ 10,000) including isolated reports
(< 1/ 10, 000) inkluż rapporti iżolati
Psychiatric disorders: very common: irritability
Disturbi psikjatriċi: komuni ħafna: irritabbiltà
au Nervous system disorders: very common: drowsiness
ux Disturbi fis- sistema nervuża: komuni ħafna: ngħas
r rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions
ad rari: kollass jew stat bħal f’ xokk (episodju ipotoniku- iporisponsiv), aċċessjonijiet
ge Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing lon Gastrointestinal disorders: very common: loss of appetite rare: vomiting no
Disturbi respiratorji toraċiċi u medjastinali: ’ g ħ rari: bronkite, sogħla
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) t uc
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) ina
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. rod
Kif intwera b’ vaċċini oħra, id- doża ta ’ rinforz hija potenzjalment assoċjata ma ’ inċidenza ogħla ta ’ effetti avversi ħfief bħal deni u reazzjonijiet lokali. diċ
Adverse reactions reported after booster vaccination are listed below.
Reazzjonijiet avversi rrappurtati wara tilqim ta ’ rinforz huma elenkati hawn taħt.
Psychiatric disorders lP
Disturbi psikjatriċi: me
Nervous system disorders: very common: drowsiness na
Disturbi fis- sistema nervuża: komuni ħafna: ngħas ott
Gastrointestinal disorders: very common: loss of appetite i dic
Disturbi gastro- intestinali: komuni ħafna: nuqqas t’ aptit od
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) Me
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) Pr
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 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.
12 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.
12 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).
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).
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
at Waqfien tan- nifs għal xi ħin fit- trabi mwieldin ħafna qabel iż- żmien (≤ 28 ġimgħa ta ’ tqala) (ara
ed 4.9 Overdose
zz sezzjoni 4. 4)
No case of overdose has been reported.
ori L- ebda każ ta ’ doża eċċessiva ma kien irrappurtat.
ris 5.
t aw 5.
tho Pharmaco-therapeutic group:
Grupp farmako- terapewtiku:
5.1 Pharmacodynamic properties
ux 5. 1 Tagħrif farmakodinamiku
au The immune response after a three-dose primary vaccination course was evaluated in five trials:
297 tarbija
Results from different
ad 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.
r ge 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.
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 ’ g ħ komplut il- kors ta ’ tilqim primarju.
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 lon mIU/ ml was 97.3%.
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%.
More than 99% of subjects were considered to have responded to the pertussis 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- derived antibodies. no
Aktar minn 99% tas- suġġetti kienu kkunsidrati li rrispondew għall- komponent pertussis tal- vaċċin, li kien definit bħala d- dehra ta ’ antikorpi f’ suġġetti li inizjalment kienu seronegattivi (jiġifieri suġġetti b’ titri < 15 im
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 t uc
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 ina
2, 4, 6 months schedule rod
skeda tat- 2, ir- 4 u s- 6 xahar diċ
3, 4, 5 months schedule
skeda tat- 3, ir- 4 u l- 5 xahar
6, 10, 14 weeks schedule
Skeda tas- 6, l- 10 ul- 14- il
N = 97
ġimgħa N = 97
98.9%
98. 9% me
95.3%
95. 3%
92.8%
92. 8%
Limited information exists on the persistence of the immune response after primary vaccination with Quintanrix as well as on the immunogenicity of booster doses.
Teżisti informazzjoni limitata dwar il- persistenza tar- rispons immuni wara t- tilqim primarju bi Quintanrix kif ukoll dwar l- immunoġeniċità tad- dożi ta ’ rinforz.
Results from one pilot study showed na
Riżultati minn studju pilota wieħed ott
that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to diphtheria, tetanus, HBs and PRP at levels considered to be protective.
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.
Forty-one percent had antibodies to pertussis.
Wieħed u erbgħin fil- mija kellhom antikorpi għall- pertussis.
Data from clinical trials show that Quintanrix, when given as a booster dose i
Tagħrif minn provi kliniċi juri li Quintanrix, meta jingħata bħala rinforz fl- età ta ’ sentejn, jinduċi tkabbir ta ’ aktar minn od
It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
10 darbiet fit- titru medju ta ’ l- antikorpi meta mqabbla mal- livelli ta ’ qabel ir- rinforz għall - komponenti kollha tal- vaċċin.
5.2 Pharmacokinetic properties
Huwa mistenni li tilqim bi Quintanrix jilqa ’ wkoll kontra l- epatite D, minħabba li l- epatite D (ikkawżata mill- aġent delta) ma sseħħx fin- nuqqas ta ’ infezzjoni bl- epatite B.
5.3 Preclinical safety data
5. 2 Tagħrif farmakokinetiku
13 No preclinical safety testing with the vaccine has been conducted.
13 Ma japplikax.
6.
at zz 6.
ed Lyophilised HIB component:
ori Komponent tal- HIB lajofilizzat:
Lactose
Lattosju
ris Liquid DTPw-HBV component:
t aw Komponent tad- DTPw- HBV likwidu:
Thiomersal
Thiomersal Sodium chloride Ilma għall- injezzjonijiet
tho Sodium chloride Water for injections.
ux Għal sustanzi awżiljari, ara taqsima 2.
For adjuvants, see section 2.
ad 6. 2 Inkompatibilitajiet
In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with
Fin- nuqqas ta ’ studji ta ’ kompatibilità, il- vaċċin Quintanrix rikostitwit m’ għandux jitħallat ma prodotti ’ g ħ mediċinali oħra.
r ge other medicinal products.
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali im
6.3 Shelf life lon 3 years.
3 snin.
After reconstitution, it is recommended to inject the vaccine promptly.
Madanakollu li l
However the stability has been demonstrated for 8 hours at 25°C after reconstitution. no
intweriet stabbiltà għal- 8 sigħat f’ temperatura ta ’ 25°C wara r- rikostituzzjoni.
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna ina
Store in a refrigerator (2°C – 8°C) t uc
Aħżen fi friġġ (2°C – 8°C)
Do not freeze. rod
Tagħmlux fil- friża. diċ
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl. me
6.5 Nature and contents of container lP
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Powder in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
Trab ġo fjala (ħġieġ tat- tip I) għal 2 dożi b’ tapp (rubber butyl).
1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl) in the following pack sizes: – pack size of 1 vial of powder plus 1 vial of suspension na
1 ml ta ’ suspensjoni fi fjala (ħġieġ tat- tip I) għal 2 dożi b’ tapp (rubber butyl) f’ pakketti ta ’ daqsijiet li ġejjin: ott
– pack size of 100 vials of powder plus 100 vials of suspension.
- pakkett bi fjala 1 ta ’ trab flimkien ma ’ fjala 1 ta ’ suspensjoni
Powder in a vial (type I glass) for 10 doses with a stopper (rubber butyl). i dic
Trab ġo fjala (ħġieġ tat- tip I) għal 10 dożi b’ tapp (rubber butyl).
5 ml of suspension in a vial (type I glass) for 10 doses with a stopper (rubber butyl) in a pack size of 50 vials of powder plus 50 vials of suspension.
5 ml ta ’ suspensjoni fi fjala (ħġieġ tat- tip I) għal 10 dożi b’ tapp (rubber butyl) f’ pakkett b ’ 50 fjala ta ’ trab flimkien ma ’ 50 fjala ta ’ suspensjoni.
6.6 Instructions for use and handling
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Upon storage, a white deposit and clear supernatant may be observed for the DTPw-HBV component.
14 Meta jinħażen, depożitu abjad u saff likwidu ċar fil- wiċċ jistgħu jiġu osservati għall- komponent DTPw- HBV.
14 The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white suspension and should be inspected visually for any foreign particulate matter and/ or abnormal physical appearance.
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.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Kull fdal
The vaccine is reconstituted by withdrawing the contents of the vial containing the DTPw-HBV
at tal- vaċċin li ma jiġix użat jew skart li jibqa ’ wara l- użu għandu jintrema kif jitolbu l- liġijiet lokali.
ed component by means of a syringe and by adding it to the vial containing the HIB powder.
zz 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.
After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until the powder is completely dissolved.
Wara li żżid il- komponent DTPw- HBV mat- trab ta ’ l - HIB, it- taħlita għandha titħawwad sewwa sakemm it- trab jinħall kollu.
The reconstituted vaccine is a homogeneous turbid white
Il- vaċċin rikostitwit huwa
ris suspension.
ori suspensjoni uniformi bajda u mdardra.
Remove and discard the needle used for reconstitution and replace it with a second needle to
Neħħi u armi l- labra li ntużat għar- rikostituzzjoni u minflokha poġġi l- labra li biha se tagħti l- vaċċin.
After reconstitution, the vaccine should be injected promptly.
t Wara r- rikostituzzjoni, il- vaċċin għandu jiġi injettat immedjatament.
When using a multidose vial, each 0.5 ml dose of the reconstituted suspension should be taken with a sterile needle and syringe.
aw Meta tkun qed tuża fjala b’ ħafna dożi, kull 0. 5ml ta ’ suspensjoni rikostitwita għandha tinġibed b’ labra u siringa sterili.
As with other vaccines, a dose of vaccine should be withdrawn under
Bħal f’ kull vaċċin ieħor, id- doża tal- vaċċin għandha tinġibed f’ kundizzjonijiet mhux settiċi u għandhom jittieħdu prekawzjonijiet biex jiġi evitat l- ikkontaminar
au strict aseptic conditions and precautions taken to avoid contamination of the contents.
ux tal- kontenut.
MARKETING AUTHORISATION HOLDER
DETENTUR TA ’ L- AWTORIZZAZZJONI GĦATQEGĦID FIS- SUQ
Rue de l'Institut 89 B-1330 Rixensart, Belgium lon 8.
GlaxoSmithKline Biologicals s. a. ’ g ħ Rue de l' Institut 89 B- 1330 Rixensart, Il- Belġju im
MARKETING AUTHORISATION NUMBER(S) no
NUMRU( I) TA ’ L- AWTORIZZAZZJONI
EU/ 1/ 04/ 301/ 003 EU/ 1/ 04/ 301/ 004 EU/ 1/ 04/ 301/ 005 t
EU/ 1/ 04/ 301/ 004 EU/ 1/ 04/ 301/ 005 ina
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION uc
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TA ’ L - AWTORIZZAZZJONI diċ
17/ 02/ 2005 rod
17/ 02/ 2005 me
DATE OF REVISION OF THE TEXT lP i na dic Me
DATA TA ’ META GIET RIVEDUTA L- KITBA ott od Pr
15 ed ris tho r au ANNEX IIge lon A.
15 at zz ori t aw ux ad ANNESS II ’ g ħ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH no
MANIFATTUR TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U SID L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - im
RELEASE
LOTT
CONDITIONS OF THE MARKETING AUTHORISATION t uc rod lP nai dic Me
TQEGĦID FIS- SUQ ina diċ me ott od Pr
16 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
16 A MANIFATTUR TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U SID L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
ed Diphtheria toxoid, tetanus toxoid, pertussis (whole cell):
at Toxoid tad- difterite, toxoid tat- tetnu, pertussis (ċellula sħiħa):
Chiron-Behring GmbH & Co.
zz Chiron- Behring GmbH & Co.
tho Fax: +49 6421 39 47 20
ori Il- Ġermanja Tel: +49 6421 39 29 17 Fax: +49 6421 39 47 20
Haemophilus influenzae type b polysaccharide
t aw Polysaccharide tal- Haemophilus influenzae tat- tip b:
r ge Fax: + 36 28 511 999
ux L- Ungerija Tel: +36 28 511 960 Fax: + 36 28 511 999
GlaxoSmithKline Biologicals S. A.
ad GlaxoSmithKline Biologicals S. A.
89 rue de I’ Institut-1330 Rixensart lon Belgium Tel: +32 2 656 81 11 Fax: +32 2 656 80 00 no
89 rue de I’ Institut- 1330 Rixensart ’ g ħ Il- Belġju Tel: +32 2 656 81 11 Fax: +32 2 656 80 00 im
GlaxoSmithKline Biologicals S. A.
GlaxoSmithKline Biologicals S. A. li l
89 rue de I’ Institut-1330 Rixensart t
89 rue de I’ Institut- 1330 Rixensart Il- Belġju Tel: +32 2 656 81 11 ina
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. lP
Fuq il- fuljett ta ’ tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat. diċ
B CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI gĦaT- TQEGĦID FIS- SUQ me
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON na
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L - UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ ott
THE MARKETING AUTHORISATION HOLDER
Prodott mediċinali jingħata bir- riċetta tat- tabib od
Medicinal product subject to medical prescription i dic
• KUNDIZZJONIJIET OĦRA
• OTHER CONDITIONS Me
Sid din l- awtorizzazzjoni għat- tqegћid fis- suq għandu jagħti tagħrif lill- Kummissjoni Ewropea dwar Pr
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
il- pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta ’ l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
17 ed ris tho r au ge ANNEX III lon LABELLING AND PACKAGE LEAFLET t no uc rod lP nai dic Me
17 at zz ori t aw ux ad ANNESS III ’ g ħ TIKKETTA U FULJETT TA ’ TAGĦRIF im li l ina diċ me ott od Pr
18 Me dic ina lP rod uc t
18 Pr od ott me diċ ina
19 no A.
19 li l im A.
LABELLING lon ge
TIKKETTA ’ g ħ ad ux aw
ris
ori
ed
zz at
PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOR MONODOSE PRESENTATIONS
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA GĦALL- FJALI B’ DOŻA WAĦDA
ed Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate
zz Quintanrix trab u suspensjoni għal suspensjoni għall- injezzjoni Vaċċin (adsorbit) tad- difterite, tetnu, pertussis (ċellula sħiħa), epatite B (rDNA) u Haemophilus tat - tip b konjugat
tho 2.
ori t 2.
After reconstitution, 1 dose (0.5 ml) contains:
aw Wara r- rikostituzzjoni, doża 1 (0. 5 ml) ikun fiha:
au Diphtheria toxoid1 Tetanus toxoid1 Inactivated Bordetella pertussis 2
Toxoid tad- difterite1 Toxoid tat- tetnu1
r Hepatitis B surface antigen (rDNA) 2, 3
ux ≥ 60 UI Bordetella pertussis inattivat2 Antiġen tal- wiċċ ta ’ l- epatite B (rDNA) 2, 3
10 µg
4 UI 10 µg
ge Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 2
ad Polysaccharide Haemophilus influenzae tat- tip b (polyribosylribitol phosphate) 2
2.5 µg
2. 5 µg
conjugated to tetanus toxoid as a carrier 1
konjugat ma ’ toxoid tat- tetnu bħala ġarrier 1
lon
’ g ħ
adsorbed on aluminium phosphate 3
0. 26 mg Al3+ adsorbit fuq aluminium hydroxide, idratat 2 Total:
produced in Saccharomyces cerevisae cells by recombinant DNA technology no
0. 40 mg Al3+ adsorbit fuq aluminium phosphate 3 manifatturat f’ ċelluli ta ’ Saccharomyces cerevisiae b’ teknoloġija rikombinanti tad- DNA im
LIST OF EXCIPIENTS t uc
LISTA TA ’ SUSTANZI MHUX ATTIVI li l
Lactose Thiomersal Sodium chloride rod
Lattosju Thiomersal ina
Water for injections
Sodium chloride Ilma għall- injezzjonijiet diċ
PHARMACEUTICAL FORM AND CONTENTS lP
GĦAMLA FARMAĊEWTIKA U KONTENUT
Powder na
Trab u suspensjoni għal suspensjoni għall- injezzjoni me
1 Vial:
Trab Fjala 1:
Suspension 1 dose (0.5 ml) 100 x 1 dose (0.5 ml) i dic
Suspensjoni Doża 1 (0. 5 ml) 100 x doża 1 (0. 5 ml) ott
METHOD AND ROUTE(S) OF ADMINISTRATION Me
MOD TA ’ KIF U MNEJN JINGĦATA od
intramuscular use Shake well before use
użu għal ġol- muskoli Ħawwad sewwa qabel l- użu Pr
20 Keep out of the reach and sight of children.
20 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
ed 8.
at 8.
EXP {MM/ YYYY}
zz JIS {XX/ SSSS}
ris tho 9.
ori 9.
Store in a refrigerator Do not freeze
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
au Store in the original package
t aw Aħżen fi friġġ Tagħmlux fil- friża Aħżen fil- pakkett oriġinali
10.
ux 10.
r OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM
ge APPROPRIATE
ad BŻONN
Dispose of in accordance with local regulations. lon 11.
Armi skond kif jitolbu l- liġijiet lokali. ’ g ħ 11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER no
ISEM U INDIRIZZ TAD- DETENTURTA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ im
Rue de l’ Institut 89 B-1330 Rixensart, Belgium t uc
B- 1330 Rixensart, Il- Belġju ina
MARKETING AUTHORISATION NUMBER(S) rod
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/ 1/ 04/ 301/ 001 EU/ 1/ 04/ 301/ 002 lP
EU/ 1/ 04/ 301/ 001 diċ
MANUFACTURER’ S BATCH NUMBER
NUMRU TAL- LOTT TAL- MANIFATTUR me
LOT: na
LOTT: ott
GENERAL CLASSIFICATION FOR SUPPLY i dic
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
Me
Prodott mediċinali li jingħata bir- riċetta tat- tabib. od
INSTRUCTIONS ON USE
STRUZZJONIJIET DWAR L- UŻU Pr
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOR MULTIDOSE PRESENTATIONS
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA GĦALL- FJALI B’ ĦAFNA DOŻI
ed Quintanrix powder and suspension for suspension for injection, multidose Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate
zz Quintanrix trab u suspensjoni għal suspensjoni għall- injezzjoni, fjala b’ ħafna dożi Vaċċin (adsorbit) tad- difterite, tetnu, pertussis (ċellula sħiħa), epatite B (rDNA) u Haemophilus tat - tip b konjugat
Suspension 2 doses (1 ml) 100 x 2 doses (1 ml) i dic
Suspensjoni 2 Dożi (1 ml) 100 x 2 dożi (1 ml) ott
22 Keep out of the reach and sight of children.
22 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER no
ISEM U INDIRIZZ TAD- DETENTUR TA L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ im
EU/ 1/ 04/ 301/ 003 EU/ 1/ 04/ 301/ 004 lP
EU/ 1/ 04/ 301/ 003 diċ
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOR MULTIDOSE PRESENTATIONS
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA GĦALL- FJALI B’ ĦAFNA DOŻI
Suspension 50 x 10 doses (5 ml) i dic
Suspensjoni 50 x 10 dożi (5 ml) ott
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA od
intramuscular use Me
użu għal ġol- muskoli Ħawwad sewwa qabel l- użu Pr
8.
at 8.
ed EXP {MM/ YYYY}
zz JIS {XX/ SSSS}
ris 9.
ori 9.
SPECIAL STORAGE CONDITIONS
t Aħżen fi friġġ
tho Store in a refrigerator Do not freeze Store in the original package
aw Tagħmlux fil- friża Aħżen fil- pakkett oriġinali
au 10.
ux 10.
Dispose of in accordance with local regulations. ge lon 11.
ad Armi skond kif jitolbu l- liġijiet lokali. ’ g ħ 11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ im
Rue de l’ Institut 89 B-1330 Rixensart, Belgium t uc
Rue de l’ Institut 89 B- 1330 Rixensart, Il- Belġju li l
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ina
EU/ 1/ 04/ 301/ 005 rod
EU/ 1/ 04/ 301/ 005 diċ
MANUFACTURER’ S BATCH NUMBER lP
NUMRU TAL- LOTT TAL- MANIFATTUR
LOT: na
LOTT: me
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA ott
Medicinal product subject to medical prescription. i dic
Prodott mediċinali li jingħata bir- riċetta tat- tabib. od
INSTRUCTIONS ON USE Me
STRUZZJONIJIET DWAR L- UŻU Pr
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MONODOSE PRESENTATIONS
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN GĦALL- FJALI B’ DOŻA WAĦDA
ed DTPw HBV for Quintanrix I. M.
zz DTPw HBV għal Quintanrix I. M.
ris tho 2.
ori 2.
3.
t aw 3.
au EXP {MM/ YYYY}
JIS {XX/ SSSS}
r ge 4.
ux 4.
LOT: lon 5.
ad LOTT: ’ g ħ 5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM JEW PARTI INDIVIDWALI im
1 dose (0.5 ml) tno uc rod lP Me
Doża 1 (0. 5 ml) li l ina diċ me ott od Pr
26 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MONODOSE PRESENTATIONS
26 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN GĦALL- FJALI B’ DOŻA WAĦDA
ed HIB for Quintanrix I. M.
zz HIB għal Quintanrix I. M.
1 dose t no uc rod lP i na dic Me
Doża 1 li l ina diċ me ott od Pr
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN GĦALL- FJALI B’ ĦAFNA DOŻI
2 doses (1 ml) tno uc rod lP Me
2 Dożi (1 ml) li l ina diċ me ott od Pr
28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN GĦALL- FJALI B’ ĦAFNA DOŻI
2 doses t no uc rod lP i na dic Me
2 Dożi li l ina diċ me ott od Pr
29 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN GĦALL- FJALI B’ ĦAFNA DOŻI
10 doses (5 ml) tno uc rod lP i na dic Me
10 Dożi (5 ml) li l ina diċ me ott od Pr
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN GĦALL- FJALI B’ ĦAFNA DOŻI
10 doses t no uc rod lP i na dic Me
10 Dożi li l ina diċ me ott od Pr
31 Me dic ina lP rod uc t
31 Pr od ott me diċ ina
32 no B.
32 li l im ’ g ħ B.
PACKAGE LEAFLET lon ge
FULJETT TA ’ TAGĦRIF ad ux aw
r
FULJETT TA ’ TAGĦRIF
Read all of this leaflet carefully before your child starts receiving this medicine.
Aqra dan il- fuljett kollu qabel ibnek/ bintek jingħata/ tingħata dan il- vaċċin
- Keep this leaflet until your child has finished the complete vaccination course.
- Żomm dan il- fuljett sakemm ibnek/ bintek jispiċċa/ tispiċċa l- kors kollu ta ’ tilqim.
You may need to
Jista jkollok
read it again.
at bżonn terġa ’ taqrah.
- This medicine has been prescribed for your child and should not be passed on to others.
- Din il- mediċina ġiet mogħtija lil ibnek/ bintek u m’ għandekx tagħtiha lil persuni oħra.
ris In this leaflet:
F’ dan il- fuljett:
1.
ori 1.
What Quintanrix is and what it is used for 2.
X’ inhu Quintanrix u għalxiex jintuża 2.
Before your child receives Quintanrix
Kif għandu jingħata Quintanrix
How Quintanrix is given 4.
X’ effetti oħra jista ’ jkollu
Possible side effects 5.
aw 5.
Storing Quintanrix 6.
Kif taħżen Quintanrix 6.
au Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate
ux Quintanrix trab u suspensjoni għal suspensjoni għall- injezzjoni Vaċċin (adsorbit) tad- difterite, it- tetnu, il- pertussis (ċellula sħiħa), l- epatite B (rDNA) u l - Haemophilus tat- tip B konjugat
r ge vaccine (adsorbed)
ad
- The active substances contained in 1 dose (0.5 ml) of Quintanrix are:
- Is- sustanzi attivi li fiha doża waħda (0. 5 ml) ta ’ Quintanrix huma:
Diphtheria toxoid1 Tetanus toxoid1 Inactivated Bordetella pertussis 2
Toxoid tad- difterite1 Toxoid tat- tetnu1 Bordetella pertussis inattivat2
not less than 30 International Units not less than 60 International Units not less than 4 International Units
mhux anqas minn 30 Unitajiet Internazzjonali mhux anqas minn 60 Unitajiet Internazzjonali mhux anqas minn 4 Unitajiet Internazzjonali
Hepatitis B surface antigen (rDNA)
Antiġen tal- wiċċ ta ’ l- epatite B (rDNA) 2, 3 im
Haemophilus influenzae type b polysaccharide
Polysaccharide Haemophilus influenzae tat- tip b
(polyribosylribitol phosphate) 2
(polyribosylribitol phosphate) 2
conjugated to tetanus toxoid as a carrier t
konjugat ma ’ toxoid tat- tetnu bħala ġarrier li l
Total:
1 Total:
0.26 milligrams Al3+
0. 40 milligrammi Al3+ adsorbit fuq aluminium phosphate ina
3
3 manifatturat f’ ċelluli ta ’ Saccharomyces cerevisiae b’ teknoloġija rikombinanti tad - DNA
adsorbed on aluminium phosphate
- L- ingredjenti l- oħra tal- vaċċin huma: lattosju, thiomersal (preservattiv), sodium chloride u ilma
Total:
diċ
water for injections. lP
għall- injezzjonijiet.
Marketing authorisation holder and Manufacturer: na
Id- Detentur Ta ’ l- Awtorizzazzjoni għat- Tqegћid fis- Suq u l- Manifattur:
GlaxoSmithKline Biologicals s. a.
Biologicals s. a.
Rue de l’ Institut 89 B-1330 Rixensart Belgium
Rue de l’ Institut 89 B- 1330 Rixensart Il- Belġju ott
WHAT QUINTANRIX IS AND WHAT IT IS USED FOR i dic
X’ HINU QUINTANRIX U GHALXIEX JINTUZA od
Quintanrix is a white slightly milky liquid obtained by mixing the vial containing the diphtheria (D), tetanus (T), whole cell pertussis (Pw) and hepatitis B (HBV) liquid (DTPw-HBV) with the vial containing the Haemophilus influenzae type b (HIB) powder.
Quintanrix huwa likwidu abjad kemmxejn bħall- ħalib li jinkiseb bit- taħlit tal- fjala li fiha l- likwidu (DTPw- HBV) tad- difterite (D), it- tetnu (T) iċ- ċellula sħiħa tal- pertussis (Pw) u l- epatite B (HBV), mal- fjala li fiha t- trab ta ’ l - Haemophilus influenzae type b (HIB).
Both components are presented in a Me
Iż- żewġ komponenti jinstabu fi Pr
glass vial for 1 dose and must be mixed together before your child receives the vaccine.
fjala tal- ħġieġ ta ’ doża waħda u jridu jitħalltu flimkien qabel ma ’ ibnek/ bintek jirċievi/ tirċievi l - vaċċin.
Quintanrix is available in the following pack sizes:
Quintanrix jinstab fil- pakketti tad- daqsijiet li ġejjin:
- pack size of 1 vial of powder plus 1 vial of liquid
- pakkett bi fjala 1 ta ’ trab flimkien ma ’ fjala oħra ta ’ likwidu
- pack size of 100 vials of powder plus 100 vials of liquid.
- pakkett b’ 100 fjala ta ’ trab flimkien ma ’ 100 fjala ta ’ likwidu.
33 Quintanrix is a vaccine used in children to prevent five infectious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b (a type of bacteria).
Quintanrix huwa vaċċin użat fit- tfal biex jilqa ’ kontra ħames mardiet infettivi: difterite, tetnu
The vaccine works by causing the body to produce its own protection (antibodies) against these infectious diseases.
at (lockjaw), pertussis (sogħla konvulsiva), epatite B u Haemophilus influenzae tat- tip b (tip ta ’ batterju).
ed • Diphtheria:
• Id- Difterite:
Diphtheria mainly affects the airways and sometimes the skin.
Ġeneralment il -
Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.
ori passaġġi tan- nifs jiffjammaw (jintefħu) u dan jikkawża diffikultajiet serji fit- teħid tan- nifs u kultant mewt bit- taħniq.
The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even
Il- batterji jipproduċu tossin (velenu), li jista ’ jikkawża ħsara fin- nervituri, problemi tal- qalb u anke jikkawża l- mewt.
• Tetanus (Lockjaw):
t aw • It- Tetnu (lockjaw):
Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Il- batterji tat- tetnu jidħlu fil- ġisem minn qsim, grif jew ġrieħi fil- ġilda.
tho Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/ dung or wood splinters.
Ġrieħi li għandhom tendenza speċjali għall- infezzjoni huma l- ħruq tal- ġilda, il- ksur ta ’ l- għadam, ġrieħi fondi jew ġrieħi mniġġsa bil- ħamrija, trab, ħmieġ/ demel taż- żwiemel jew skald ta ’ l- injam.
The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death.
Il - batterji jerħu tossin (velenu), li jista ’ jikkawża ebusija fil- muskoli, spażmi li jweġġgħu fil- muskoli,
The muscle spasms can be strong enough to cause bone fractures of the spine.
L- ispażmi tal- muskoli jistgħu jkunu qawwija biżżejjed biex jiksru għadam mix- xewka tad- dahar.
au • Pertussis (Whooping cough):
ad • Il- Pertussis (sogħla konvulsiva):
Pertussis is a highly infectious illness.
Pertussis hija marda li tittieħed ħafna.
The coughing
Il- marda taffetwa l - passaġġi tan- nifs u tikkawża attakki serji ta ’ sogħla li jistgħu jaffettwaw it- teħid normali tan- nifs.
The
Is- sogħla ħafna drabi ġġib magħha tħarħir (whooping), mnejn ġie l- isem komuni ‘ whooping cough ’ ’ g ħ (sogħla konvulsiva).
ge cough may last for 1-2 months or longer.
Is- sogħla tista ’ ddum bejn xahar u xaharejn u anke aktar.
Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death. lon • Hepatitis B:
Il- pertussis tista ’ wkoll tikkawża infezzjoni fil- widnejn, bronkite li tista ’ tieħu fit- tul, pulmonite, aċċessjonijiet, ħsara fil- moħħ u saħansitra mewt. im
Infection with the hepatitis B virus may cause the liver to become swollen (inflamed).
Infezzjoni bil- virus ta ’ l- epatite B tikkawża nefħa (infjammazjoni) fil- fwied.
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Il- virus jinsab fil- likwidi tal- ġisem bħad- demm, is- semen, it- tisfija tal- vaġina, jew is- saliva (bżiq) tal - persuni infettati.
Signs of the disease may not be seen for 6 weeks to 6 months after infection.
Sinjali tal- marda jistgħu ma ’ jkunux jidhru minn 6 ġimgħat sa 6 xhur wara l - li l
Sometimes people who have been infected do not look or feel ill.
Xi drabi persuni li jkunu infettati ma jidhrux jew ma jħossuhomx morda.
Others have signs of mild flu, but some people can become very ill.
Oħrajn ikollhom sinjali ta ’ influwenza ħafifa iżda xi wħud ikunu morda ħafna.
They may be extremely tired, and have dark urine, pale no
Huma jistgħu ikunu għajjenin ħafna, ikollhom l- awrina skura, wiċċhom bla kulur, ġilda safranija u/ jew sfura fl- abjad ta ’ ina
faces, yellowish skin and/ or eyes (jaundice), and other signs of the disease possibly requiring hospitalisation.
l- għajnejn (suffejra) u sintomi oħra tal- marda li għalihom jista ’ jkollhom bżonn jittieħdu l- isptar.
Most adults fully recover from the disease.
Ħafna mill- adulti ifiequ għal kollox mill- marda.
But some people, particularly children, who may not t uc
Madankollu xi nies, partikolarment it- tfal, li diċ
have shown signs of the disease can remain infected.
setgħu ma urewx sinjali ta ’ mard jistgħu jibqgħu infettati.
They are called hepatitis B virus carriers.
Dawn jissejħu carriers tal- virus ta ’ l - epatite B.
Hepatitis B carriers can infect others throughout their lives.
Carriers ta ’ l- epatite B jistgħu jinfettaw oħrajn tul ħajjithom.
Hepatitis B carriers are at risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer. rod
Carriers ta 'l- epatite B għandhom ir- riskju ta' mard serju tal- fwied, bħal ċirrożi (ċikatriżazzjoni tal- fwied) u kanċer tal - fwied. me
• Haemophilus influenzae type b (HIB):
• Il- Haemophilus influenzae tat- tip b (HIB):
HIB infection most frequently causes brain inflammation (swelling).
Infezzjoni tal- HIB ħafna drabi tikkawża infjammazzjoni (nefħa) fil- moħħ.
There will be some type of serious complications such as: mental retardation, cerebral palsy, deafness, epilepsy or partial blindness.
Ikun hemm xi tipi ta ’ kumplikazzjonijiet serji bħal tfigħ lura fl - iżvilupp mentali, paraliżi ċerebrali, truxija, epilessija jew nuqqas ta` dawl.
HIB infection also causes inflammation of the throat. lP
L- infezzjoni tal- HIB tikkawża wkoll infjammazzjoni fil- gerżuma.
It occasionally causes death by suffocation.
B’ mod anqas ott
Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth. na
komuni, l- batterji jistgħu jinfettaw id- demm, il- qalb, il- pulmuni, l- għadam, il- ġogi, kif ukoll it - tessuti ta ’ l- għajnejn u tal- ħalq. od
The hepatitis B and Haemophilus influenzae type b components of Quintanrix can only help to protect your child against infections with hepatitis B or Haemophilus influenzae type b viruses.
Il- komponenti ta ’ l- epatite B u l- Haemophilus influenzae tat- tip b ta ’ Quintanrix jistgħu jgħinu biss biex f’ ibnek/ f’ bintek jilqgħu kontra infezzjonijiet permezz tal- viruses ta ’ l- epatite B u l - Haemophilus influenzae tat- tip b.
Me
34 il- fwied jew kontra infezzjonijiet minħabba batterji oħra li m’ humiex Haemophilus influenzae tat- tip b jew kontra meninġite ikkawżata minn organiżmi oħra.
BEFORE YOUR CHILD RECEIVES QUINTANRIX
QABEL MA IBNEK / BINTEK JIEĦU/ TIEĦU QUINTANRIX
In the following cases, Quintanrix should not be given to your child.
at Fil- każijiet li ġejjin, Quintanrix m’ għandiex tingħata lill- ibnek/ bintek.
You must tell your doctor:
Inti għandek tgħid lit -
• if your child has experienced any health problems after previous administration of a vaccine.
• Jekk ibnek/ bintek kellu/ kellha problemi ta ’ saħħa meta fil- passat ingħata/ ingħatat vaċċin.
34 • if your child has previously had any allergic reaction to Quintanrix, or any ingredient contained in this vaccine.
ori • jekk ibnek/ bintek kellu/ kellha xi reazzjoni allerġika għal Quintanrix, jew għal kwalunke ingredjent li fih dan il- vaċċin.
The active substances and other ingredients in Quintanrix are listed at the beginning of the leaflet.
Is- sustanzi attivi u l- ingredjenti l- oħra li jinstabu fi Quintanrix huma elenkati fil- bidu ta` dan il- fuljett.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough), hepatitis B or Haemophilus influenzae type b diseases.
t fil- ġilda li jġagħlek tħokk, qtugħ ta ’ nifs, u nefħa fil- wiċċ jew fl- ilsien.
ed • if your child experienced problems of the nervous system (such as repetitive fits, decrease of consciousness) within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease.
aw • jekk ibnek/ bintek kellu/ kellha xi reazzjoni allerġika għal kwalunkwe vaċċin kontra l- mard tad - difterite, tat- tetnu, tal- pertussis (sogħla konvulżiva), ta ’ l- epatite B jew tal- Haemophilus influenzae tat- tip b. • jekk ibnek/ bintek kellu/ kellha xi problemi fis- sistema nervuża (bħal aċċessjonijiet ripetittivi,
A minor infection such as a cold should not be a problem, but talk to your doctor first.
ux nuqqas ta ’ koxjenza) fi żmien sebat ijiem wara li tlaqqam/ tlaqqmet kontra l- pertussis (sogħla konvulżiva). • jekk ibnek/ bintek għandu/ għandha xi infezzjoni qawwija b`deni għoli (’ l fuq minn 38°C).
tho • if your child has any known allergies.
ad F’ dawn il- każijiet il - vaċċinazzjoni tkun posposta sakemm it- tifel/ tifla jirkupra/ tirkupra.
In the following cases, your doctor can determine the right time and scheme of vaccination for
Infezzjoni ħafifa bħal riħ, m’ għandiex tkun problema, iżda l- ewwel dejjem ikkonsulta mat- tabib. • jekk ibnek/ bintek ibati/ tbati minn xi allerġiji li taf bihom. ’ g ħ Fil- każijiet li ġejjin, it- tabib tiegħek jista ’ jiddetermina l- aħjar żmien u skeda ta ’ tilqim għal - ibnek/ bintek.
Tell your doctor:
Għid lit- tabib tiegħek: im
• if after previously having Quintanrix or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially:
• jekk wara xi tilqim fil- passat bi Quintanrix jew b’ xi vaċċin ieħor kontra l- pertussis (sogħla konvulżiva), ibnek/ bintek kellu/ kellha xi problemi speċjalment: ♦ Deni għoli (‘ l fuq minn 40° C) fi żmien 48 siegħa mit- tilqima li l
r ♦ A high temperature (over 40°C) within 48 hours of vaccination
♦ Kollass jew stat bħal f’ xokk fi żmien 48 siegħa mit- tilqima ♦ Biki persistenti li jdum tliet sigħat jew aktar fi żmien 48 siegħa mit- tilqima ina
Your no
♦ Aċċessjonijiet b`deni għoli jew mingħajr deni għoli fi żmien 3 ijiem mit- tilqima • jekk ibnek/ bintek għandu/ għandha problema ta ’ fsada jew jekk jitbenġel/ titbenġel malajr. • jekk ibnek/ bintek għandu/ għandha tendenza għall- aċċessjonijiet minħabba deni għoli, jew jekk hemm storja ta ’ dan fil- familja. diċ
doctor will be able to tell you what to do if Quintanrix is to be given with another vaccine or medicine.
It- tabib ikun jista ’ jgħidlek x’ għandek tagħmel jekk Quintanrix jkun se jingħata flimkien ma ’ vaċċin ieħor jew mediċina oħra. me
Important information about some of the ingredients of Quintanrix t uc
Informazzjoni importanti dwar xi sustanzi ta ’ Quintanrix
This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction.
Dan il- prodott mediċinali fih thiomersal bħala preservattiv u huwa possibbli li ibnek/ bintek ikollu/ ikollha reazzjoni allerġika.
Tell you doctor if your child has any known allergies. rod
Għid lit- tabib tiegħek jekk ibnek/ bintek għandu/ għandha xi allerġiji ott
HOW QUINTANRIX IS GIVEN
KIF JINGĦATA QUINTANRIX
Your child will receive a total of three injections with an interval of at least one month between each lP
Ibnek/ bintek se jirċievi/ tirċievi total ta ’ tliet injezzjonijiet b’ intervall ta ’ mill- anqas xahar bejn kull Pr
one.
waħda.
Each injection is given on a separate visit.
Kull injezzjoni tingħata f’ vista separata.
The first injection can be given from the age of 6 weeks onwards.
L- ewwel injezzjoni tista ’ tingħata mill- età ta ’ 6 ġimgħat il- quddiem.
You will be informed by the doctor or nurse when you should come back for subsequent injections. na
Inti se tkun infurmat/ a mit- tabib jew l- infermier tiegħek meta għandek terġa ’ tmur għall- injezzjonijiet li jkun imiss.
The doctor or nurse will give Quintanrix as an injection into the muscle.
It- tabib jew l- infermier jagħtu Quintanrix bħala injezzjoni fil- muskolu.
Your doctor will advise on the possible need for extra doses. i dic
35 It- tabib tiegħek jinfurmak jekk ikun hemm bżonn ta ’ dożi żejda.
Me
Jekk ibnek/ bintek jitlef/ titlef vista skedata għat- tieni jew it- tielet injezzjoni, kellem lit- tabib tiegħek u għamel arranġament għal vista oħra kemm jista ’ jkun malajr.
Make sure your child finishes the complete vaccination course of three injections.
at Żgura li ibnek/ bintek jispiċċa/ tispiċċa l- kors kollu ta ’ tlett injezzjonijiet ta ’ tilqim.
If not, your child may not be fully protected against the diseases.
Jekk le, ibnek/ bintek jista ’ / tista’ ma ’ jkunx/ tkunx kompletament protett/ a kontra dan il- mard.
The vaccine should never be given into a vein.
zz Il- vaċċin m’ għandu qatt jingħata fil- vina.
35 4.
ori 4.
Any vaccine can have some side effects.
t Kwalunkwe vaċċin jista ’ jkollu xi effetti oħra.
Side effects that occurred during clinical trials with Quintanrix were as follows:
aw Effetti oħra li ġraw waqt provi kliniċi bi Quintanrix kienu kif ġej:
ed ♦ Very common (more than 1 per 10 doses of vaccine): • Pain, redness or swelling at the injection site • Fever (more than 37.5°C)
♦ Komuni ħafna (aktar minn każ wieħed minn kull 10 dożi ta ’ vaċċin):
ris • Irritability • Loss of appetite • Drowsiness
ux • Uġigħ, ħmura jew nefħa fis- sit ta ’ l- injezzjoni • Deni (aktar minn 37. 5°C) • Irritabilità
tho ♦ Common (less than 1 per 10 but more than 1 per 100 doses of vaccine): • Induration (hard lump)
ad • Nuqqas t’ aptit • Ngħas ’ g ħ ♦ Komuni (anqas minn każ wieħed minn kull 10 dożi iżda aktar minn każ wieħed minn kull 100 doża ta ’ vaċċin): • Boċċa iebsa im
au • Fever (more than 39°C)
• Deni (aktar minn 39°C)
♦ Rare (less than 1 per 1000 but more than 1 per 10 000 doses of vaccine): • Bronchitis
♦ Rari (anqas minn każ wieħed minn kull 1000 doża iżda aktar minn każ wieħed minn kull 10 000 doża ta ’ vaċċin): li l
r • Coughing
• Bronkite • Sogħla ina
ge • Vomiting • Collapse (floppiness) or periods of unconsciousness or lack of awareness • Fits lon Bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets have been reported very rarely (less than 1 per 10,000 doses of vaccine) with the hepatitis B component of Quintanrix. no
Rari ħafna (anqas minn każ wieħed minn kull 10, 000 doża ta ’ vaċċin) kienu rrappurtati fsada jew tbenġil aktar faċilment mis- soltu minħabba tnaqqis fl- ammont ta ’ tip ta ’ ċelluli tad- demm imsejħa plejtlits bil- komponent ta ’ l- epatite B ta ’ Quintanrix. me
As with all injectable vaccines, there is an extremely small risk of allergic reactions.
Bħal vaċċini kollha li jingħataw b’ injezzjoni, hemm riskju żgħir ta ’ reazzjonijiet allerġiċi.
Such reactions t
Dawn jistgħu jkunu raxx lokali jew mifrux fejn ikun hemm ħakk jew jitilgħu l- bżieżaq, nefħa fl- għajnejn jew fil- wiċċ, diffikultà biex tieħu n- nifs jew tibla ’, pressjoni li taqa ’ f’ daqqa u telf ta ’ koxjenza.
may occur before leaving the doctor’ s surgery.
Reazzjonijiet bħal dawn jistgħu jiġru qabel ma ’ titlaq mingħand it- tabib.
However, you should seek immediate treatment in any uc
Madanakollu għandek tfittex ott
event.
trattament immedjat f’ kull każ.
If these events continue or become severe, tell your doctor. rod
Jekk dawn il- ġrajjiet ikomplu jew isiru serji, għid lit- tabib tiegħek. od
This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction. lP
Pr
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tinnota xi effetti oħra li m’ humiex imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib jew lill- ispiżjar tiegħek.
Do not be alarmed by this list of possible side effects.
36 Tieħux qatgħa b’ din il- lista ta ’ effetti sekondarji li jista ’ jkun hemm.
It is possible that your child will have no side na
Huwa possibbli li ibnek/ bintek ma ’ jkollux/ jkolliex effetti sekondarji mit- tilqim.
STORING QUINTANRIX
KIF TAĦŻEN QUINTANRIX
Store in a refrigerator (2°C – 8°C).
at Aħżen fi friġġ (2°C – 8°C).
Me
zz Żommu fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
Keep out of the reach and sight of children.
ori Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use after the expiry date stated on the pack.
Tużax wara d- data ta ’ skadenza li tidher fuq il- pakkett.
The date for last use corresponds to the last day of the month mentioned.
Id- data sa meta jista ’ intuża l- aħħar hija l- aħħar
36 6.
aw 6.
FURTHER INFORMATION
AKTAR INFORMAZZJONI
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
ux Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegћid fis- Suq.
Tél/ Tel: + 32 2 656 21 11
ad Luxembourg/ Luxemburg België/ Belgique/ Belgien GlaxoSmithKline s. a. / n. v.
Tél/ Tel: + 32 2 656 21 11
Tél/ Tel: + 32 2 656 21 11 Tél/ Tel: + 32 2 656 21 11 ’ g ħ Magyarország България ГлаксоСмитКлайн ЕООД ул.
ris България ГлаксоСмитКлайн ЕООД
im
Magyarország GlaxoSmithKline Kft.
Tel.: + 36- 1- 2255300
Димитър Манов бл .10 София 1408 Тел. + 359 2 953 10 34
София 1408 Тел. + 359 2 953 10 34 li l
au Č eská republika GlaxoSmithKline s. r. o.
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r ge Danmark GlaxoSmithKline Pharma A/ S Tlf: + 45 36 35 91 00
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Nederland GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100
Tel: + 31 (0) 30 69 38 100 Tlf: + 45 36 35 91 00 nlinfo@ gsk. com info@ glaxosmithkline. dk me
Tlf: + 47 22 70 20 00 firmapost@gsk. no
KG Tlf: + 47 22 70 20 00 Tel: + 49 (0) 89 360448701 firmapost@ gsk. no produkt. info@ gsk. com ott
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GlaxoSmithKline Eesti OÜ Tel: + 43 1 970 75- 0 Tel: +372 667 6900 od
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