qanastek/EMEA-V3 huggingface dataset:
The reconstituted vaccine presents as a slightly more cloudy suspension than the liquid component alone.
Il- vaċċin rikostitwit jidher bħala suspensjoni iżjed mdardra mill- likwidu waħdu.
This is normal and does not impair the performance of the vaccine.
Din hija normali u bl - ebda mod ma taffettwa l- funzjoni tal- vaċċin.
21 A.
21 ANNESS II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturers of the biological active substances
Isem u indirizz tal- manifatturi tas- sustanzi bijoloġiċi attivi
Rue de l’ Institut 89, 1330 Rixensart Belgium
Rue de l’ Institut 89, 1330 Rixensart Belġju
76, D-35041 Marburg Germany
76, D- 35041 Marburg Ġermanja
The holder of the marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jinforma lil Kummissjoni Ewropeja dwar il- pjanijiet għat- tqegħid fis- suq għall- prodott mediċinali awtorizzat minn din id- deċisjoni.
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC kif emendata, il- ħruġ tal- lott uffiċjali isir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
The holder of marketing authorisation will continue to submit annual PSURs.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jkompli jissottometti PSURs kull sena.
23 A.
23 ANNESS III
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 20 VIALS AND 20 PRE-FILLED SYRINGES WITHOUT NEEDLES 50 VIALS AND 50 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 VIAL AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES 20 VIALS AND 20 PRE-FILLED SYRINGES WITH 40 NEEDLES 50 VIALS AND 50 PRE-FILLED SYRINGES WITH 100 NEEDLES
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KUNJETT U SIRINGA 1 MIMLIJA LESTA MINGĦAJR LABRA 10 KUNJETTI U 10 SIRINGI MIMLIJIN LESTI MINGĦAJR LABAR 20 KUNJETT U 20 SIRINGA MIMLIJIN LESTI MINGĦAJR LABAR 50 KUNJETT U 50 SIRINGA MIMLIJIN LESTI MINGĦAJR LABAR KUNJETT U SIRINGA 1 MIMLIJA LESTA B’ 2 LABRIET 10 KUNJETTI U 10 SIRINGI MIMLIJIN LESTI B’ 20 LABRA 20 KUNJETT U 20 SIRINGA MIMLIJIN LESTI B’ 40 LABRA 50 KUNJETT U 50 SIRINGA MIMLIJIN LESTI B’ 100 LABRA
Infanrix hexa – Powder and suspension for suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus type b (Hib) conjugate vaccine (adsorbed)
Vaċċin (adsorbit) konjugat tad- difterite (D), tetnu (T), sogħla konvulsiva (komponent aċellulari) (Pa), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV), u Haemophilus ta’ tip b (Hib).
After reconstitution, 1 dose (0.5 ml):
Wara r- rikostituzjoni, doża 1 (0. 5 ml) fiha:
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis antigens
Toxoid tad- difterite1 Toxoid tat- tetnu1 Antigeni tal- Bordatella pertussis
(Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1) Hepatitis B surface antigen2 Poliovirus (inactivated) type 1, 2, 3 Haemophilus type b polysaccharide (polyribosylribitol phosphate) 2
(Toxoid tal- Pertussis1, Filamentous haemagglutinin1, Pertactin1) Antiġen tas- superfiċje ta ’ l- epatite B 2 Poliovirus (inattivat) tip 1, 2, 3 Haemophilus tip b polysaccharide (polyribosylribitol phosphate) 2
conjugated to tetanus toxoid as carrier protein 1
konjugat ma ’ toxoid tat- tetnu bħala proteina ġarriera 1
adsorbed on Al(OH)3 2
adsorbit fuq (Al (OH) 3 2
adsorbed on AlPO4
adsorbit fuq (AlPO4)
Lactose anhydrous Sodium chloride Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
Lactose anhydrous Sodium chloride Medium 199 li prinċipalment fih amino acids, mineral salts, vitamini Ilma għall- injezzjonijiet
Powder and suspension for suspension for injection Vial: powder Pre-filled syringe: suspension
Trab u suspensjoni għall- injezzjoni Kunjett: trab Siringa mimlija lesta: suspensjoni
1 vial and 1 pre-filled syringe 1 dose (0.5 ml)
Kunjett u siringa 1 mimlija lesta Doża 1 (0. 5 ml)
10 vials and 10 pre-filled syringes 10 x 1 dose (0.5 ml)
10 kunjetti u 10 siringi mimlijin lesti 10 x 1 doża (0. 5 ml)
25 20 vials and 20 pre-filled syringes 20 x 1 dose (0.5 ml)
26 20 kunjett u 20 siringa mimlijin lesti 20 x 1 doża (0. 5 ml)
50 vials and 50 pre-filled syringes 50 x 1 dose (0.5 ml)
50 kunjett u 50 siringa mimlijin lesti 50 x 1 doża (0. 5 ml)
1 vial and 1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
Kunjett u siringa 1 mimlija lesta + 2 labriet 1 doża (0. 5 ml)
10 vials and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 kunjetti 10 siringi mimlijin lesti + 20 labra 10 x 1 doża (0. 5 ml)
20 vials and 20 pre-filled syringes + 40 needles 20 x 1 dose (0.5 ml)
20 kunjett u 20 siringai mimlijin lesti + 40 labra 20 x 1 doża (0. 5 ml)
50 vials and 50 pre-filled syringes + 100 needles 50 x 1 dose (0.5 ml)
50 kunjett u 50 siringa mimlijin lesti + 100 labra 50 x 1 doża (0. 5 ml)
Read the package leaflet before use Intramuscular use Shake before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu Użu fil- muskolu Ħawwad sew qabel l- użu
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
Aħżen fi friġġ Tagħmlux fil- friża Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
26 Rue de l’ Institut 89 B-1330 Rixensart, Belgium
Rue de l’ Institut 89 B- 1330 Rixensart, Belġju
EU/ 1/ 00/ 152/ 001 - 1 vial and 1 pre-filled syringe without needle EU/ 1/ 00/ 152/ 002 - 10 vials and 10 pre-filled syringes without needles EU/ 1/ 00/ 152/ 003 - 20 vials and 20 pre-filled syringes without needles EU/ 1/ 00/ 152/ 004 - 50 vials and 50 pre-filled syringes without needles EU/ 1/ 00/ 152/ 005 - 1 vial and 1 pre-filled syringe with 2 needles EU/ 1/ 00/ 152/ 006 - 10 vials and 10 pre-filled syringes with 20 needles EU/ 1/ 00/ 152/ 007 - 20 vials and 20 pre-filled syringes with 40 needles EU/ 1/ 00/ 152/ 008 - 50 vials and 50 pre-filled syringes with 100 needles
EU/ 1/ 00/ 152/ 001 - kunjett 1 u siringa mimlija lesta mingħajr labra EU/ 1/ 00/ 152/ 002 - 10 kunjetti u 10 siringi mimlija lesta mingħajr labar EU/ 1/ 00/ 152/ 003 - 20 kunjett u 20 siringa mimlijin lesti mingħajr labar EU/ 1/ 00/ 152/ 004 – 50 kunjett u 50 siringa mimlija lesta mingħajr labar EU/ 1/ 00/ 152/ 005 – kunjett 1 u siringa 1 mimlija lesta b’ 2 labriet EU/ 1/ 00/ 152/ 006 – 10 kunjetti u 10 siringi mimlija lesti b’ 20 labra EU/ 1/ 00/ 152/ 007 - 20 kunjett u 20 siringa mimlija lesti b’ 40 labra EU/ 1/ 00/ 152/ 008 - 50 kunjett u 50 siringa mimlija lesti b’ 100 labra
LOT:
Lott
Medicinal product subject to medical prescription
Prodott medicinali li jingħata bir- riċetta tat- tabib
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL WITH BIOSET® AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 VIALS WITH BIOSET® AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 20 VIALS WITH BIOSET® AND 20 PRE-FILLED SYRINGES WITHOUT NEEDLES 50 VIALS WITH BIOSET® AND 50 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 VIAL WITH BIOSET® AND 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 VIALS WITH BIOSET® AND 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 20 VIALS WITH BIOSET® AND 20 PRE-FILLED SYRINGES WITH 20 NEEDLES 50 VIALS WITH BIOSET® AND 50 PRE-FILLED SYRINGES WITH 50 NEEDLES 1 VIAL WITH BIOSET® AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS WITH BIOSET® AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
28 29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KUNJETT BIL- BIOSET® U SIRINGA 1 MIMLIJA LESTA MINGĦAJR LABAR 10 KUNJETTI BIL- BIOSET® U 10 SIRINGI MIMLIJIN LESTI MINGĦAJR LABAR 20 KUNJETT BIL- BIOSET® U 20 SIRINGA MIMLIJIN LESTI MINGĦAJR LABAR 50 KUNJETT BIL- BIOSET® U 50 SIRINGA MIMLIJIN LESTI MINGĦAJR LABAR KUNJETT BIL- BIOSET® U SIRINGA 1 MIMLIJA LESTA B’ LABRA WAĦDA 10 KUNJETTI BIL- BIOSET® U 10 SIRINGI MIMLIJIN LESTI B’ 10 LABRIET 20 KUNJETT BIL- BIOSET® U 20 SIRINGA MIMLIJIN LESTI B’ 20 LABRA 50 KUNJETT BIL- BIOSET® U 50 SIRINGA MIMLIJIN LESTI B’ 50 LABRA KUNJETT BIL- BIOSET® U SIRINGA WAĦDA MIMLIJA LESTA B’ 2 LABRIET 10 KUNJETTI BIL- BIOSET® U 10 SIRINGI MIMLIJIN LESTI B’ 20 LABRA
Infanrix hexa – Powder and suspension for suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus type b (Hib) conjugate vaccine (adsorbed)
Vaċċin (adsorbit) konjugat tad- difterite (D), tetnu (T), sogħla konvulsiva (komponent aċellulari) (Pa), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV), u Haemophilus ta’ tip b (Hib).
Diphtheria toxoid1 Tetanus toxoid1 Pertussis antigens
Toxoid tad- difterite1 Toxoid tat- tetnu1 Antigeni tal- Bordatella pertussis
Lactose anhydrous Sodium chloride Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
Lactose anhydrous Sodium chloride Medium 199 li prinċipalment fih amino acids, mineral salts, vitamini Ilma għall - injezzjonijiet
Powder and suspension for suspension for injection Vial with Bioset® Cap: powder Pre-filled syringe: suspension 1 vial with bioset® and 1 pre-filled syringe 1 dose (0.5 ml)
Trab u suspensjoni għall- suspensjoni għall- injezzjoni Kunjett bit- Tapp Bioset®: trab Siringa mimlija lesta: suspensjoni Kunjett 1 bil- bioset® u siringa 1 mimlija lesta Doża 1 (0. 5 ml)
10 vials with bioset® and 10 pre-filled syringes
10 kunjetti bil- bioset® u 10 siringi mimlijin lesti 10 x 1 doża (0. 5 ml)
20 vials with bioset® and 20 pre-filled syringes 20 x 1 dose (0.5 ml)
30 20 kunjett bil- bioset® u 20 siringa mimlijin lesti 20 x 1 doża (0. 5 ml)
50 vials with bioset® and 50 pre-filled syringes 50 x 1 dose (0.5 ml)
50 kunjett bil- bioset® u 50 siringa mimlijin lesti 50 x 1 doża (0. 5 ml)
1 vial with bioset® and 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
Kunjett 1 bil- bioset® u siringa 1 mimlija lesta + 1 labra 1 doża (0. 5 ml)
10 vials with bioset® and 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
10 kunjetti bil- bioset® u 10 siringi mimlijin lesti + 10 labriet 10 x 1 doża (0. 5 ml)
20 vials with bioset® and 20 pre-filled syringes + 20 needles 20 x 1 dose (0.5 ml)
20 kunjett bil- bioset® u 20 siringai mimlijin lesti + 20 labra 20 x 1 doża (0. 5 ml)
50 vials with bioset® and 50 pre-filled syringes + 50 needles 50 x 1 dose (0.5 ml)
50 kunjett bil- bioset® u 50 siringa mimlijin lesti + 50 labra 50 x 1 doża (0. 5 ml)
1 vial with bioset® and 1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
Kunjett 1 bil- bioset® u siringa 1 mimlija lesta + 2 labriet 1 x doża (0. 5ml)
10 vials with bioset® and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 kunjetti bil- bioset® u 10 siringi mimlijin lesti + 20 labra 10 x 1 doża (0. 5ml)
Read the package leaflet before use Intramuscular use Shake before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu Użu fil- muskolu Ħawwad qabel l- użu
Rue de l’ Institut 89 B-1330 Rixensart, Belgium
Rue de l’ Institut 89 B- 1330 Rixensart, Belġju
EU/ 1/ 00/ 152/ 009 - 1 vial with bioset® and 1 pre-filled syringe without needle EU/ 1/ 00/ 152/ 010 - 10 vials with bioset® and 10 pre-filled syringes without needles EU/ 1/ 00/ 152/ 011 - 20 vials with bioset® and 20 pre-filled syringes without needles EU/ 1/ 00/ 152/ 012 - 50 vials with bioset® and 50 pre-filled syringes without needles EU/ 1/ 00/ 152/ 013 - 1 vial with bioset® and 1 pre-filled syringe with 1 needle EU/ 1/ 00/ 152/ 014 - 10 vials with bioset® and 10 pre-filled syringes with 10 needles EU/ 1/ 00/ 152/ 015 - 20 vials with bioset® and 20 pre-filled syringes with 20 needles EU/ 1/ 00/ 152/ 016 - 50 vials with bioset® and 50 pre-filled syringes with 50 needles EU/ 1/ 00/ 152/ 017 - 1 vial with bioset® and 1 pre-filled syringe with 2 needles EU/ 1/ 00/ 152/ 018 - 10 vials with bioset® and 10 pre-filled syringes with 20 needles
EU/ 1/ 00/ 152/ 009 - kunjett 1 bil- bioset® u siringa mimlija lesta mingħajr labra EU/ 1/ 00/ 152/ 010 - 10 kunjetti bil- bioset® u 10 siringi mimlija lesta mingħajr labar EU/ 1/ 00/ 152/ 011 - 20 kunjett bil- bioset® u 20 siringa mimlijin lesti mingħajr labar EU/ 1/ 00/ 152/ 012 – 50 kunjett bil- bioset® u 50 siringa mimlija lesta mingħajr labar EU/ 1/ 00/ 152/ 013 – kunjett 1 bil- bioset® u siringa 1 mimlija lesta b’ 1 labra EU/ 1/ 00/ 152/ 014 – 10 kunjetti bil- bioset® u 10 siringi mimlija lesti b’ 10 labriet EU/ 1/ 00/ 152/ 015 - 20 kunjett bil- bioset® u 20 siringa mimlija lesti b’ 20 labra EU/ 1/ 00/ 152/ 016 - 50 kunjett bil- bioset® u 50 siringa mimlija lesti b’ 50 labra EU/ 1/ 00/ 152/ 017 – kunjett 1 bil- bioset® u siringa 1 mimlija lesta b’ 2 labriet EU/ 1/ 00/ 152/ 018 – 10 kunjetti bil- bioset® u 10 siringi mimlija lesti b’ 20 labra
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH HIB POWDER VIAL WITH BIOSET CAP WITH HIB POWDER
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN KUNJETT BIT- TRAB TAL- HIB KUNJETT BIT- TAPP TAL- BIOSET BIT- TRAB TAL- HIB
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL - PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
HIB for Infanrix hexa Powder for suspension for injection I. M.
HIB għal Infanrix hexa Trab għal suspensjoni għall- injezzjoni I. M.
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH DTPA HBV IPV SUSPENSION
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA MIMLIJA LESTA BIS- SUSPENSJONI TAL - DTPA HBV IPV
DTPa HBV IPV for Infanrix hexa Suspension for suspension for injection I. M.
DTPa HBV IPV għal Infanrix hexa Suspensjoni u suspensjoni għall- injezzjoni I. M.
INFORMATION FOR THE USER
35 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Infanrix hexa, Powder and suspension for suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus type b (HIB) conjugate vaccine (adsorbed).
Infanrix hexa, trab u suspensjoni għall- suspensjoni għall- injezzjoni Vaċċin (adsorbit) konjugat għad- difterite (D), tetnu (T), sogħla konvulsiva (komponent aċellulari) (Pa), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV), u Haemophilus ta’ tip B (Hib).
Read all of this leaflet carefully before your child receives this vaccine.
Aqra dan il- fuljett sew qabel ma ’ 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 itemmu l- kors kollu ta ’ din it- tilqima.
You may need to
Jista ’ jkollok
read it again.
bżonn terġa taqrah.
- If you have any further questions, ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet staqsi lit- tabib jew lill- ispiżjar tiegħek.
- This vaccine has been prescribed for your child.
- Dan il- vaċċin ġie mgħoti għat- tifel/ tifla tiegħek.
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew l- ispiżjar tiegħek.
What Infanrix hexa is and what it is used for 2.
X’ inhi Infanrix hexa u għalxiex tintuża 2.
Before your child receives Infanrix hexa 3.
Qabel ma ibnek/ bintek jieħdu Infanrix hexa 3.
How Infanrix hexa is given 4.
Kif tingħata Infanrix hexa 4.
Possible side effects 5.
X’ effetti oħra jista ’ jkollha 5.
How to store Infanrix hexa 6.
Kif taħżen Infanrix hexa 6.
WHAT Infanrix hexa IS AND WHAT IT IS USED FOR
X’ INHI Infanrix hexa U GĦALXIEX TINTUŻA
Infanrix hexa is a vaccine used in children to prevent six diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, poliomyelitis (Polio) and Haemophilus influenzae type b.
Infanrix Hexa hija vaċċin għat- tfal biex tipproteġihom kontra sitt mardiet infettivi: difterite, tetnu (lockjaw), pertussis (sogħla konvulsiva), epatite B, poljomelite (Polio) u Haemophilus influenzae tip b.
The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Il- vaċċin jaħdem billi jġiegħel lill- ġisem jipproduċi l- protezzjoni (anti- korpi) tiegħu stess kontra dan il- mard.
• Diphtheria:
• Difterite:
Diphtheria mainly affects the airways and sometimes the skin.
Id- Difterite taffettwa l- aktar il- passaġġi tan- nifs u xi kultant il- ġilda.
Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.
Ġeneralment il - passaġġi tan- nifs jiffjammaw (jintefħu) u dan jikkawża diffikultajiet serji biex jieħu n- nifs kif u kultant jifga lil dak li jkun.
The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.
Il- batterji jipproduċu tossin (velenu), li jista ’ jikkawża problemi fin - nervituri, problemi tal- qalb u anki jikkawża l- mewt.
• Tetanus (Lockjaw):
• Tetnu (lockjaw):
Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Il- batterji tat- tetnu jidħlu fil ġisem minn qsim, grief jew ġrieħi fil- ġilda.
Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/ dung or wood splinters.
Ġrieħi li faċilment iġibu infezzjonijiet huma ħruq tal- ġilda, 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 jitilqu tossin (velenu), li jista ’ jikkawża ebusija fil- muskoli, spażmi li jiġgħaw fil- muskoli, aċċessjonijiet u anki l - mewt.
The muscle spasms can be strong enough to cause bone fractures of the spine.
L- ispażmi tal- muskoli jistgħu jkunu tant qawwija li anki jaslu biex jiksru xi għadam tax - xewka tad- dahar.
• Pertussis (Whooping cough):
• Pertussis (sogħla konvulsiva):
Pertussis is a highly infectious illness.
Petussis hija marda li tittieħed ħafna.
The disease affects the airways causing severe spells of coughing that may interfere with normal breathing.
Il- marda taffetwa l- passaġġi tan- nifs u tikkawżaw attakki ta ’ sogħla fit- tul li jistgħu jaffettwaw in- nifs.
The coughing is often accompanied by a “ whooping” sound, hence the common name “ whooping cough”.
Is- sogħla ħafna drabi ġġib magħha tħarħir (whooping), mnejn ġie l- isem komuni ‘ whooping cough ’ (sogħla konvulsiva).
The cough may last for 1-2 months or longer.
Is- sogħla tista ’ ddum xahar jew xaharejn u anki aktar.
Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death.
Pertussis tista ’ wkoll tikkawża infezzjoni fil - widnejn, bronkite litista ’ tieħu fit- tul, pulminite, aċċessjonijiet, ħsara fuq il- moħħ u saħansitra mewt.
• Hepatitis B:
• Epatite B:
Hepatitis B is caused by the hepatitis B virus.
Epatite B hija kkawżata mill- virus ta ’ l- epatite B.
It causes the liver to become swollen (inflamed).
Din tista ’ ġġib nefħa (infjammazjoni) fil- fwied.
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Il- virus jinsab fil- fluwidi tal- ġisem bħad- demm, semen, tnixxijiet tal- vaġina, jew saliva (bżiq) ta ’ nies infettati.
• Poliomyelitis (Polio):
• Poljomelite (Polio):
Poliomyelitis, sometimes called simply “ polio” is a viral infection that can have variable effects.
Poljomelite, xi kultant imsejjħa ‘ polio ’ hija infezzjoni virali li jista ’ jkollha effetti varji.
Often it causes only a mild illness but in some people it causes permanent damage or even death.
Ħafna drabi tikkawża mard ħafif iżda f’ xi wħud tikkawża ħsara permanenti kif ukoll mewt.
In its severest form, polio infection causes paralysis of the muscles (muscles cannot move), including those muscles needed for breathing and walking.
Fl- agħar tagħha, l- marda tal- polio tikkawża paraliżi fil- muskoli (il- muskoli ma jistgħux 36 jiċċaqalqu), li jinkludu dawk il- muskoli li huma meħtieġa għall- mixi, jew għan- nifs.
The limbs affected by the disease may be painfully deformed.
Ir- riġlen jew dirgħajn affettwati minn din il- marda jistgħu jiġu sfigurati u jkunu juġgħaw.
34 • Haemophilus influenzae type b (Hib):
• Haemophilus influenzae ta` tip b (Hib):
Hib infection most frequently causes brain inflammation (swelling).
Infezzjoni tal- Hib ħafna drabi tikkawża infjammazzjoni fil- moħħ, (nefħa).
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 mard mentali, cerebral palsy, nuqqas ta ’ smigħ, epilessija jew nuqqas ta` dawl.
Hib infection also causes inflammation of the throat.
L- infezzjoni tal- Hib tikkawża wkoll infjammazzjoni fil- griżmej.
It occasionally causes death by suffocation.
Xi drabi tikkawża mewt għax tifga lil dak li jkun.
Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.
Anqas komuni, l - batterja tista ’ tinfetta d- demm, il- qalb, il- pulmun, l- għadam, il- ġogi, kif ukoll it- tessuti tal- għajnejn u tal- ħalq.
Vaccination is the best way to protect against these diseases.
It- tilqim hu l- aħjar protezzjoni kontra dan il- mard.
None of the components in the vaccine are infectious.
L- ebda komponent fil- vaċċin m`huma ineffetiv.
BEFORE YOUR CHILD RECEIVES Infanrix hexa
QABEL MA IBNEK/ BINTEK JIEĦDU Infanrix hexa
Infanrix hexa should not be given:
Infanrix hexa m’ għandux jingħata:
• if your child has previously had any allergic reaction to Infanrix hexa, or any ingredient contained in this vaccine.
• jekk ibnek/ bintek qatt kellhomx xi reazzjoni allerġika għal Infanrix hexa, jew għal xi ingredjent li fih dan il- vaċċin.
The active substances and other ingredients in Infanrix hexa are listed at the end of the leaflet.
Is- sustanzi attivi u l- ingredjenti l- oħra li jista’ bu f’ Infanrix hexa huma elenkati fl- aħħar 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, poliomyelitis or Haemophilus influenzae type b diseases. • if your child experienced problems of the nervous system within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease. • if your child has a severe infection with a high temperature (over 38°C).
Is- sinjali ta` reazzjoni allerġika jistgħu jinkludu, raxx tal- ġilda flimkien ma ’ ħakk, qtugħ ta ’ nifs, u nefħa fil- wiċċ jew fl- ilsien. • jekk ibnek/ bintek kellhom xi reazzjonijiet allerġika għal xi vaċċin kontra l- marda tad- difterite, tetnu, pertussis (sogħla konvulżiva), epatite B, poljomelite jew mard tal- Haemophilus influenzae tip b. • jekk ibnek/ bintek kellhom xi problemi fis- sistema nervuża fi żmien sebat ijiem wara li tlaqqmu kontra l- petussis (sogħla konvulżiva). • jekk ibnek/ bintek għandhom xi infezzjoni qawwija b`deni għoli (‘ l fuq minn 38°C).
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Infezzjoni minuri bħal riħ, m’ għandiex tkun poblema, iżda qabel dejjem ikkonsulta mat- tabib.
Take special care with Infanrix hexa:
Oqgħod attent ħafna b’ Infanrix hexa
• if after previously having Infanrix hexa or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/ fits with or without a high temperature within 3 days of vaccination • if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
• jekk wara xi tiqim fl- ingħoddi b’ Infanrix hexa jew xi vaċċin ieħor kontra l- pertussis (sogħla konvulżiva), ibnek/ bintek kellhom xi problemi speċjalment: ♦ Deni għoli (‘ l fuq minn 40° C) fi żmien 48 siegħa mit- tilqima ♦ Kollass jew stat qisu ta ’ xokk fi żmien 48 siegħa mit- tilqima ♦ Biki persistenti ta` tlett sigħat jew aktar fi żmien 48 siegħa mit- tilqima ♦ Aċċessjonijiet b`deni għoli jew mingħar deni għoli fi żmien 48 siegħa mit- tilqima • jekk ibnek/ bintek qed ibatu minn xi marda tal- moħħ mhux dijanjostikata jew progressiva jew epilessija mhux ikkontrollata.
After control of the disease the vaccine should be administered. • if your child has a bleeding problem or bruises easily • if your child has a tendency to seizures/ fits due to a fever, or if there is a history in the family of this As with all vaccines, Infanrix hexa may not completely protect all people who are vaccinated.
Wara li l- marda tiġi kkontrollata, il- vaċċin għandu jingħata. • jekk ibnek/ bintek għanhom problema ta ’ fsada (ħruġ ta ’ demm) jew jitbenġlu malajr. • Jekk ibnek/ bintek għandhom tendenza għall- aċċessjonijiet meta jitlagħlhom deni għoli, jew jekk hemm min ibati jew kien ibati minn hekk fil- familja Bħal vaċċini l- oħra kollha, Infanrix hexa jista 'ma jipproteġix kompletament in- nies kollha li jkunu mlaqqma.
Using other medicines or vaccines Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Meta tuża mediċini jew vaċċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk bintek/ ibnek qed jieħdu jew ħadu dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, jew jekk ħadu xi tilqim ieħor dan l- aħħar
Important information about some of the ingredients of Infanrix hexa Please tell your doctor if your child has had an allergic reaction to neomycin and polymyxin (antibiotics).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Infanrix hexa Jekk jogħġbok għid lit- tabib tiegħek jekk bintek/ ibnek qatt kellhom xi reazzjoni allerġika għal neomycin u polymyxin (antibijotiċi)
HOW Infanrix hexa IS GIVEN
KIF TINGĦATA Infanrix hexa
Your child will receive a total of two or three injections with an interval of at least one month between each one.
37 Ibnek/ bintek ser jieħdu total ta ’ żewġ jew tlett injezzjonijiet b’ intervall ta ’ mill- anqas xahar bejn waħda u oħra.
Each injection is given on a separate visit.
Kull injezzjoni tingħata f`vista tat- tabib separata.
You will be informed by the doctor or nurse when you should come back for subsequent injections.
It- tabib jew l- infirmier jinfurmawk meta għandek terġa ’ tmur għall- injezzjoni li jmiss.
35 If additional injections or “ booster” are necessary, the doctor will tell you.
It- tabib jinfurmak f`każ li jkun hemm il- bżonn ta` aktar injezzjonijiet jew ‘ booster ’.
If your child misses a scheduled injection, talk to your doctor and arrange another visit.
Jekk ibnek/ bintek jitilfu injezzjoni skedata infurmaw lit- tabib u għamlu appuntament ieħor.
Make sure your child finishes the complete vaccination course of three injections.
Kun żgur li ibnek/ bintek jispiċċaw il- kors kollu ta ’ tliet injezzjonijiet.
If not, your child may not be fully protected against the diseases.
Jekk le, ibnek/ bintek jistgħu ma jkunux pprotetti kontra dan il- mard.
The doctor will give Infanrix hexa as an injection into the muscle.
It- tabib jagħti Infanrix hexa permezz ta ’ injezzjoni fil- muskolu.
The vaccine should never be given into blood vessels or into the skin.
It- tilqima m`għandha qatt tingħata f’ arterja/ vina tad- demm jew fil- ġilda.
As with all injectable vaccines, there is an extremely small risk of serious allergic reactions (anaphylactic and anaphylactoid reactions).
Bħal kull mediċina oħra, Infanrix hexa jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd. • Bħal ma ’ jista ’ jiġri b’ kull vaċċin li jingħata b’ injezzjoni, hemm riskju żgħir ħafna ta ’ reazzjonijiet allerġiċi serji (reazzjonijiet anafilatiċi u anafilaktojdi).
Signs of serious allergic reactions may be: • rashes that may be itchy or blistering • swelling of the eyes and face • difficulty in breathing or swallowing • a sudden drop in blood pressure and loss of consciousness.
Sinjali ta ’ reazzjonijiet allerġiċi serji jistgħu ikunu: • raxx li jista 'jkun bil- ħakk jew bl- infafet • nefħa fl- għajnejn u fil- wiċċ • diffikultajiet tan- nifs kif ukoll biex tibla • il- pressjoni tad- demm tinżel f’ daqqa u tintilef minn sensik.
Such reactions will usually occur before leaving the doctor’ s surgery.
Dawn ir- reazzjonijiet normaliment tħosshom qabel ma toħroġ mill- klinika tat- tabib.
However, if your child gets any of these symptoms you should contact a doctor urgently.
Madanakollu jekk it- tarbija tiegħek ikolla xi wieħed minn dawn is- sintomi għandek tikkuntattja it- tabib mill- ewwel.
As with other vaccines against pertussis (whooping cough) disease, following side effects may occur very rarely within 2 to 3 days after vaccination: • collapse or periods of unconsciousness or lack of awareness • seizures or fits with or without fever If your child gets any of these side effects you should contact a doctor urgently.
Bħal b’ vaċċini oħra kontra l- pertussis (sogħla konvulsiva) dawn l- effetti sekondarji jistgħu jidhru rarament ħafna fi żmien 2 sa 3 ijiem wara t- tilqim: • kollass jew perjodi fejn tintilef minn sensik jew ma tkunx taf x' qed jiġri • aċċessjonijiet bi jew mingħajr deni Jekk it- tarbija tiegħek ikolla xi wieħed minn dawn l- effetti sekondarji għandek tikkuntattja tabib mill - ewwel.
Other side effects that have been reported are:
Effetti sekondarji oħra li ġew irrapurtati huma:
Very common (These may occur in 1 in 10 doses or more of the vaccine) • loss of appetite • fever greater than or equal to 38°C • swelling, pain, redness at the injection site • tiredness • abnormal crying, irritability, restlessness.
Komuni ħafna (Dawn jistgħu jiġru f’ 1 minn 10 dożi jew aktar tat- tilqima) • nuqqas ta ’ aptit • deni ta ’ aktar minn jew ta ’ 38˚C • nefħa, uġigħ, ħmura fis- sit ta ’ l- injezzjoni • għejja • biki mhux normali, irritabilita ’, tħossok ma jkollokx kwiet
Common (These may occur in up to 1 in 10 doses of the vaccine) • diarrhoea, vomiting • fever greater than 39.5°C • swelling larger than 5 cm at the injection site, hard lump at the injection site • nervousness.
Komuni (Dawn jistgħu jiġru f’ sa 1 minn 10 dożi tat- tilqima) • dijarrea, rimettar • deni ta ’ aktar minn 39. 5˚C • nefħa ta ’ aktar minn 5cm fis- sit ta ’ l- injezzjoni, għoqda iebsa fis- sit ta ’ l- injezzjoni • nervożita ’
Uncommon (These may occur in up to 1 in 100 doses of the vaccine) • sleepiness • cough • large swelling at the injected limb.
Mhux komuni (Dawn jistgħu jiġru f’ sa 1 minn 100 doża tat- tilqima) • ħedla tan- nagħas • sogħla • nefħa kbira fid- driegħ fejn tkun ingħatat l- injezzjoni
Rare (These may occur in up to 1 in 1,000 doses of the vaccine) • rash.
38 Rari (Dawn jistgħu jiġru f' sa 1 minn kull 1, 000 doża tat- tilqima) • raxx
36 • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination. • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) • dermatitis • swelling of the entire injected limb, vesicles at the injection site.
Rari ħafna (Dawn jistgħu jiġru f' sa 1 minn kull 10, 000 doża tat- tilqima) • glandoli minfuħa fl- għonq, taħt id- driegħ jew bejn il- koxxa u ż- żaqq (limfadeneopatija) • fi trabi li jitwieldu ħafna qabel iż- żmien (fi jew qabel it- 28 ġimgħa ta ’ ġestazzjoni) jista ’ jkun hemm perjodi itwal minn normal bejn nifs u ieħor għal 2- 3 ijiem wara t- tilqima • nefħa fil- wiċċ, ix- xufftejn, il- ħalq, l- ilsien jew il- griżmejn li jista ’ jikkawża diffikulta ’ biex tibla ’ jew biex tieħu nifs (anġjoedema) • dermatite • nefħa tad- driegħ kollu fejn tkun ingħatat l- injezzjoni.
HOW TO STORE Infanrix hexa
KIF TAĦŻEN Infanrix hexa
Do not use Infanrix hexa after the expiry date which is stated on the carton.
Tużax Infanrix hexa wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ (2°C – 8°C) Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
Store in the original package in order to protect from light.
Tagħmlux fil- friża.
Freezing destroys the vaccine.
Il- vaċċin ma jibqax tajjeb fil- friża.
What Infanrix hexa contains
X’ fih Infanrix hexa
type 1 (Mahoney strain) 4 type 2 (MEF-1 strain) 4 type 3 (Saukett strain) 4
tip 1 (tar- razza Mahoney) 4 tip 2 (tar- razza MEF- 1) 4 tip 3 (tar- razza Saukett) 4 Haemophilus tip b polysaccharide (polyribosylribitol phosphate) 3
adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
adsorbit fuq aluminium oxide hydrated (Al( OH) 3 2
2 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3
manifatturat fuq ċelloli tal- ħmira (Saccharomyces cerevisae) b’ teknoloġija rekombinanti tad - DNA 3
adsorbed on aluminium phosphate (AlPO4)
adsorbit fuq aluminium phosphate (AlPO4)
4 propagated in VERO cells
4 propogati f’ ċelloli VERO
- The other ingredients in Infanrix hexa are:
- Is- sustanzi l- oħra f’ Infanrix hexa huma:
Hib powder: lactose anhydrous
Trab tal- Hib: lactose anhydrous
DTPa-HBV-IPV suspension: sodium chloride (NaCl), medium 199 containing principally amino acids, mineral salts, vitamins and water for injections
DTPa- HBV- IPV: sodium chloride (NaCl), medium 199 li fih prinċipalment amino acids, mineral salts, vitamini u ilma għall- injezzjonijiet
37 What Infanrix hexa looks like and contents of the pack
Id- Dehra ta ’ Infanrix hexa u d- daqs tal- pakkett:
Powder and suspension for suspension for injection.
Trab u suspensjoni għall- suspensjoni għall- injezzjoni.
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).
Il- komponent tad- difterite, tetnu, pertussis aċellulari, epatite B, poliomelite inattivat (DTPA- HBV- IPV) hu likwidu abjad, ftit imdardar bħall- ħalib u jkun f`siringa mimlija lesta (0. 5ml).
The Hib component is a white powder presented in a glass vial.
Il- komponenti tal- Hib huwa trab abjad li jinstab fi kunjett tal- ħġieġ.
Both components must be mixed together before your child receives the vaccine.
Iż- żewġ komponenti għandhom jitħalltu flimkien qabel ma ’ t- tifel/ tifla tiegħek jingħataw il- vaċċin.
The mixed appearance is a white, slightly milky liquid.
It - taħlita hija likwidu abjad, ftit imdardar bħall- ħalib.
Infanrix hexa is available in packs of 1, 10, 20 and 50 with or without needles.
Infanrix hexa tinstab f`pakketti ta ’ 1, 10, 20 u 50 bil- labar jew mingħajr labar.
Marketing Authorisation Holder and Manufacturer
Id- Detentur Ta’ L- Awtorizzazzjoni Għat- Tqegħid Fis- Suq u l- Manifattur
Rue de l’ Institut 89 B-1330 Rixensart Belgium
Rue de l`Institut 89 B- 1330 Rixensart Belġju
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/. --------------------------------------------------------------------------------------------------------------------------- ---
41 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /. ------------------------------------------------------------------------------------------------------------------------------
Upon storage, a white deposit and clear supernatant can be observed.
Meta jinħażen, depożitu abjad u sustanza ċara f- wiċċ l- ilma jistgħu jiġu osservati.
39 The DTPa-HBV-IPV suspension should be inspected visually for any foreign particulate matter and/or variation of physical aspect.
Is- suspensjoni tad- DTPa- HBV- IPV għandha tiġi spezzjonata viżwalment biex wieħed jara jekk hemmx xi frak u/ jew xi dehra fiżika mhux normali.
In the event of either being observed, discard the container.
F`każ li jiġri hekk, il- vaċċin għandu jintrema.
The mixture should then be well shaken until the powder is completely dissolved.
Wara li jiżdied il- vaċċin DTPa- HBV- IPV mat- trab, it- taħlita għandha tiġi mħallta sew sakemm it- trab jinħall kompletament.
INFORMATION FOR THE USER
42 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Do not pass it on to others.
- Dan il- vaċċin ġie mgħoti għat- tifel/ tifla tiegħek Tagħtihiex lil persuni oħra.
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 faċilment iġibu infezzjonijiet huma ħruq tal- ġilda, ksur ta ’ l- għadam, ġrieħi fondi jew ġrieħi mniġġsa bil- ħamrija, trab, ħmieġ/ demel taż- żwiemel jew skald ta ’ l- injam.
The coughing is often accompanied by a “whooping” sound, hence the common name “whooping cough”.
Is- sogħla ħafna drabi ġġib magħha tħarħir (whooping), mnejn ġie l- isem komuni ‘ whooping cough ’ (sogħla konvulsiva).
Poliomyelitis, sometimes called simply “polio” is a viral infection that can have variable effects.
Poljomelite, xi kultant imsejjħa ‘ polio ’ hija infezzjoni virali li jista ’ jkollha effetti varji.
In its severest form, polio infection causes paralysis of the muscles (muscles cannot move), including those muscles needed for breathing and walking.
Fl- agħar tagħha, l- marda tal- polio tikkawża paraliżi fil- muskoli (il- muskoli ma jistgħux
The limbs affected by the disease may be painfully deformed.
43 jiċċaqalqu), li jinkludu dawk il- muskoli li huma meħtieġa għall- mixi, jew għan- nifs.
41 • Haemophilus influenzae type b (Hib):
• Haemophilus influenzae ta` tip b (Hib):
• if after previously having Infanrix hexa or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/fits with or without a high temperature within 3 days of vaccination • if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
• jekk wara xi tiqim fl- ingħoddi b’ Infanrix hexa jew xi vaċċin ieħor kontra l - pertussis (sogħla konvulżiva), ibnek/ bintek kellhom xi problemi speċjalment: ♦ Deni għoli (‘ l fuq minn 40° C) fi żmien 48 siegħa mit- tilqima ♦ Kollass jew stat qisu ta ’ xokk fi żmien 48 siegħa mit- tilqima ♦ Biki persistenti ta` tlett sigħat jew aktar fi żmien 48 siegħa mit- tilqima ♦ Aċċessjonijiet b`deni għoli jew mingħar deni għoli fi żmien 48 siegħa mit- tilqima • jekk ibnek/ bintek qed ibatu minn xi marda tal- moħħ mhux dijanjostikata jew progressiva jew epilessija mhux ikkontrollata.
After control of the disease the vaccine should be administered. • if your child has a bleeding problem or bruises easily • if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of this As with all vaccines, Infanrix hexa may not completely protect all people who are vaccinated.
Wara li l- marda tiġi kkontrollata, il- vaċċin għandu jingħata. • jekk ibnek/ bintek għanhom problema ta ’ fsada (ħruġ ta ’ demm) jew jitbenġlu malajr. • Jekk ibnek/ bintek għandhom tendenza għall- aċċessjonijiet meta jitlagħlhom deni għoli, jew jekk hemm min ibati jew kien ibati minn hekk fil- familja Bħal vaċċini l- oħra kollha, Infanrix hexa jista ’ ma jipprotegix kompletament in- nies kollha li jkunu mlaqqma.
Your child will receive a total of two or three injections with an interval of at least one month between each one.
44 Ibnek/ bintek ser jieħdu total ta ’ żewġ jew tlett injezzjonijiet b’ intervall ta ’ mill- anqas xahar bejn waħda u oħra.
42 If additional injections or “booster” are necessary, the doctor will tell you.
It- tabib jinfurmak f`każ li jkun hemm il- bżonn ta` aktar injezzjonijiet jew ‘ booster ’.
Like all medicines, Infanrix hexa can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Infanrix hexa jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
As with all injectable vaccines, there is an extremely small risk of serious allergic reactions (anaphylactic and anaphylactoid reactions).
Bħal ma ’ jista ’ jiġri b’ kull vaċċin li jingħata b’ injezzjoni, hemm riskju żgħir ħafna ta ’ reazzjonijiet allerġiċi serji (reazzjonijiet anafilattiċi jew anafilaktojdi).
Signs of serious allergic reactions may be: • rashes that may be itchy or blistering • swelling of the eyes and face • difficulty in breathing or swallowing • a sudden drop in blood pressure and loss of consciousness.
Sinjali ta ’ reazzjonijiet allerġiċi serji jistgħu ikunu: • raxx li jista ’ jkun bil- ħakk jew bl- infafet. • nefħa fl- għajnejn u fil- wiċċ • diffikultajiet tan- nifs kif ukoll biex tibla • il- pressjoni tad- demm tinżel f’ daqqa u tintilef minn sensik.
Such reactions will usually occur before leaving the doctor’s surgery.
Dawn ir- reazzjonijiet normaliment tħosshom qabel ma toħroġ mill- klinika tat- tabib.
However, if your child gets any of these symptoms you should contact a doctor urgently.
Madanakollu jekk it- tarbija tiegħek ikolla xi wieħed minn dawn is- sintomi għandek tikkuntatja lit- tabib mill- ewwel.
As with other vaccines against pertussis (whooping cough) disease, following side effects may occur very rarely within 2 to 3 days after vaccination: • collapse or periods of unconsciousness or lack of awareness • seizures or fits with or without fever If your child gets any of these side effects you should contact a doctor urgently.
Bħal b’ vaċċini oħra kontra l- pertussis (sogħla konvulsiva) dawn l- effetti sekondarji jistgħu jidhru fi żmien 2 sa 3 ijiem wara t- tilqim: • kollass jew perjodi fejn tintilef minn sensik jew ma tkunx taf x' qed jiġri • aċċessjonijiet bi jew mingħajr deni Jekk it- tarbija tiegħek ikolla xi wieħed minn dawn l- effetti sekondarji għandek tikkuntattja tabib mill - ewwel.
Rare (These may occur in up to 1 in 1,000 doses of the vaccine) • rash.
45 Rari (Dawn jistgħu jiġru f' sa 1 minn kull 1, 000 doża tat- tilqima) • raxx
43 • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination. • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) • dermatitis • swelling of the entire injected limb, vesicles at the injection site.
Rari ħafna (Dawn jistgħu jiġru f' sa 1 minn kull 10, 000 doża tat- tilqima) • glandoli minfuħa fl- għonq, taħt id- driegħ jew bejn il- koxxa u ż- żaqq (limfadeneopatija) • fi trabi li jitwieldu ħafna qabel iż- żmien (fi jew qabel it- 28 ġimgħa ta ’ ġestazzjoni) jista ’ jkun hemm perjodi itwal minn normal bejn nifs u ieħor għal 2- 3 ijiem wara t- tilqima • nefħa fil- wiċċ, ix- xufftejn, il- ħalq, l- ilsien jew il- griżmejn li jista ’ jikkawża diffikulta ’ biex tibla ’ jew biex tieħu nifs (anġjoedema) • dermatite • nefħa tad- driegħ kollu fejn tkun ingħatat l- injezzjoni.
44 What Infanrix hexa looks like and contents of the pack
Id- Dehra ta ’ Infanrix hexa u d- daqs tal- pakkett:
The Hib component is a white powder presented in a glass vial with Bioset®.
Il- komponenti tal- Hib huwa trab abjad li jinstab fi kunjett tal- ħġieġ b’ Bioset®.
Rue de l’Institut 89 B-1330 Rixensart Belgium
Rue de l`Institut 89 B- 1330 Rixensart Belġju
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
47 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Ísland GlaxoSmithKline ehf.
48 Ísland GlaxoSmithKline ehf.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
46 The DTPa-HBV-IPV suspension should be inspected visually for any foreign particulate matter and/or variation of physical aspect.
Is- suspensjoni tad- DTPa- HBV- IPV għandha tiġi spezzjonata viżwalment biex wieħed jara jekk hemmx xi frak u/ jew xi dehra fiżika mhux normali.
The Bioset® is a specially designed cap which simplifies reconstitution.
Il- Bioset® huwa tapp speċjali magħmul biex jissemplifika ir- rikostituzzjoni.
It is good clinical practice to only inject a vaccine when it has reached room temperature.
Skond prattika medika, il- vaċċin għandu jiġi injettat biss meta t- temperatura tiegħu tkun laħqet it - temperatura tal- kamra.
In addition, a vial at room temperature ensures sufficient elasticity of the rubber closure to minimise any coring of rubber particles.
Barra minn hekk, f’ temperatura tal- kamra, l- elastiċita ’ tat- tapp tal- lastiku tal - kunjett tkun aħjar u din tnaqqas il- possibilita ’ ta ’ tifrik tal- lastiku.
To achieve this, the vial should be kept at room temperature (25 ± 3 °C) for at least five minutes before connecting the syringe and reconstituting the vaccine.
Għal din ir- raġuni, il- kunjett għandha tinżamm f’ temperatura tal- kamra (25 ± 3 °C) għal ta ’ l- anqas ħames minuti, qabel ma ’ titwaħħal is- siringa u qabel ma ’ l- vaċċin jiġi rikostitwit.
For reconstitution, twist the cover from the Bioset® cap and remove the cap from the syringe.
Għar- rikostituzzjoni, dawwar u neħħi l- għatu tal- Bioset® u neħħi t- tapp minn mas- siringa.
Connect the syringe onto the Bioset® by twisting it.
Waħħal is- siringa mal- Bioset® billi ddawwara.
Push downwards until syringe ‘clicks’ into position.
Mbotta s- siringa l- isfel sakemm tisma ‘ klikk ’ li tindika li s- siringa qiegħda f’ posta.
Inject liquid, mix thoroughly until powder is completely dissolved.
Injetta il- kontenut tas- siringa fil- kunjett u ħawwad sew sakemm it- trab jinħall kompletament.
Aspirate reconstituted vaccine back into syringe.
Iġbed lura l - vaċċin rikostitwit ġewwa s- siringa.
Unscrew syringe from Bioset®.
Ħoll is- siringa minn mal- Bioset®.
Affix a needle for administration.
Waħħal il- labra għall - injezzjoni bil- vaċċin.
The reconstituted vaccine presents as a slightly more cloudy suspension than the liquid component alone.
49 Il- vaċċin rikostitwit jidher bħala suspensjoni iżjed mdardra mill- likwidu waħdu.
EMEA/ H/ C/ 295
EMEA/ H/ C/ 296
What is Infanrix Penta?
X’ inhu Infanrix Penta?
Infanrix Penta is a vaccine, which is available as a suspension for injection.
Infanrix Penta huwa vaċċin li jinsab disponibbli bħala sospensjoni għall- injezzjoni.
It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, parts of Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus and inactivated (killed) polioviruses.
Din il- mediċina fiha dawn iż- żewġ sustanzi attivi: tossojdi (tossojdi mdgħajfa kimikament) mid- difterite u t- tetnu, partijiet minn Bordetella pertussis (batterju li jikkawża sogħla ħoxna konvulsiva), partijiet mill- vajrus tal- epatite B u polivajrus mhux attivat (maqtul).
What is Infanrix Penta used for?
Għalxiex jintuża Infanrix Penta?
It is also used as a booster vaccination.
Infanrix Penta jintuża għat- tilqim ta ’ trabi u tfal żgħar taħt l- età ta ’ tliet snin kontra d- difterite, t- tetnu, il- pertussi (sogħla ħoxna konvulsiva), l- epatite B u l- poljomjelite (poljo) Jintuża wkoll bħala tilqima ‘ booster ’.
How is Infanrix Penta used?
Kif jintuża Infanrix Penta?
The recommended vaccination schedule for Infanrix Penta is two or three doses, given at least one month apart, usually within the first six months of life.
Il- programm rakkomandat għat- tilqim ta ’ Infanrix Penta huwa ta ’ tnejn jew tliet dożi meħuda mill - inqas xahar ‘ il bogħod minn xulxin, normalment fi żmien l- ewwel sitt xhur tal- ħajja.
Infanrix Penta is given by deep injection into a muscle.
Infanrix Penta jingħata permezz ta ’ injezzjoni fonda fil- muskolu.
A booster dose of Infanrix Penta or a similar vaccine must be given at least six months after the last dose of the initial course.
Doża booster ta ’ Infanrix Penta jew vaċċin simili għandu jingħata minn tal- inqas sitt xhur wara l- aħħar doża tal- kors inizjali.
The choice of which vaccine to use depends on official recommendations.
L- għażla ta ’ liema vaċċin għandu jintuża jiddependi mir- rakkomandazzjonijiet uffiċjali.