qanastek/EMEA-V3 huggingface dataset:
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 5 micrograms/ 0.5 ml - single dose vial - Pack of 1, 10
HBVAXPRO 5 mikrogrammi/ 0. 5 ml – doża waħda fi fjala Pakketti ta ’ 1, 10
HBVAXPRO 5 micrograms/ 0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogrammi/ 0. 5 ml Suspensjoni għall- injezzjoni Vaċċin ta ’ l- Epatite B (rDNA)
1 dose (0.5 ml) contains:
Doża 1 (0. 5 ml) fiha:
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
Antiġen rikombinanti tal- wiċċ tal- virus tEpatite B *.............................
5.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)
5. 00 mikrogrammi Assorbiti fuq (0. 25 milligrammi Al+) ta ’ aluminium hydroxyphosphate sulfate, amorfu
* produced from recombinant strain of the yeast Saccharomyces cerevisiae (strain 2150-2-3)
* magħmul mir- razza rikombinanti tal- ħmira Saccharomyces cerevisiae (razza 2150- 2- 3)
Sodium chloride, borax and water for injections.
Sodium chloride, borax u ilma għall- injezzjonijiet.
Suspension for injection 1 single dose 0.5 ml vial 10 single doses 0.5 ml vials
Suspensjoni għall- injezzjoni Doża waħdanija fi fjala ta ’ 0. 5 ml 10 dożi singoli fi fjali ta ’ 0. 5 ml
Shake well before use.
Ħawwad sew qabel ma tuża.
Read the package leaflet before use.
Aqra l- fuljett tal- pakkett qabel ma tuża.
Intramuscular use.
Għal użu ġol- muskolu.
Store in a refrigerator Do not freeze
Aħżen fil- friġġ Tiffiżahx
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon France
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F- 69007 Lyon Franza
EU/ 1/ 01/ 183/ 001 1 vial EU/ 1/ 01/ 183/ 018 10 vials
EU/ 1/ 01/ 183/ 001 fjala waħda EU/ 1/ 01/ 183/ 018 10 fjali
INFORMATION IN BRAILLE
INFORMAZZJONI FIL- BRAILLE
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 5 micrograms/ 0.5 ml - single dose vial + syringe with needle - Pack of 1
HBVAXPRO 5 mikrogrammi/ 0. 5 ml – doża waħda + siringa bil- labra – Pakkett ta ’ 1
HBVAXPRO 5 micrograms/ 0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogrammi/ 0. 5 ml Suspensjoni għall- injezzjoni Vaċċin ta ’ Epatite B (rDNA)
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
Antiġen rikombinanti tal- wiċċ tal- virus ta ’ Epatite B *.........................
Suspension for injection 1 single dose 0.5 ml vial 1 sterile injection syringe with needle.
Suspensjoni għall- injezzjoni Doża waħda ta ’ 0. 5 ml fi fjala Siringa sterili għall- injezzjoni b’ labra.
Intramuscular use.
Għall- użu ġol- muskolu.
43 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
39 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
HBVAXPRO 5 micrograms/ 0.5 ml
HBVAXPRO 5 mikrogrammi/ 0. 5 ml
HBVAXPRO 5 µg/ 0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 5 µg/ 0. 5 ml Suspensjoni għall- injezzjoni Vaċċin ta ’ l- Epatite B (rDNA)
IM use
IM use
EXPIRY DATE
DATA TA ’ META JISKADI EXPIRY DATE
OTHER
6 OĦRAJN
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 5 micrograms/ 0.5 ml - single dose pre-filled syringe without needle - Pack of 1, 10, 20, 50
HBVAXPRO 5 mikrogrammi/ 0. 5 ml – siringa mingħajr labra mimlija diġà b’ doża waħda – Pakkett ta ’ 1, 10, 20, 50
HBVAXPRO 5 micrograms/ 0.5 ml Suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogrammi/ 0. 5 ml Suspensjoni għall- injezzjoni f’ siringa mimlija lesta Vaċċin ta ’ Epatite B (rDNA)
Suspension for injection 1 single dose 0.5 ml pre-filled syringe without needle 10 single dose 0.5 ml pre-filled syringes without needle 20 single dose 0.5 ml pre-filled syringes without needle 50 single dose 0.5 ml pre-filled syringes without needle
Suspensjoni għall- injezzjoni Doża waħda ta’ 0. 5 ml f’ siringa mimlija lesta mingħajr labra 10 dożi waħedhom ta’ 0. 5 ml f’ siringi mimlijin lesti mingħajr labra 20 dożi waħedhom ta’ 0. 5 ml f’ siringi mimlijin lesti mingħajr labra 50 dożi waħedhom ta’ 0. 5 ml f’ siringi mimlijin lesti mingħajr labra
EU/ 1/ 01/ 183/ 004 1 pre-filled syringe EU/ 1/ 01/ 183/ 005 10 pre-filled syringes EU/ 1/ 01/ 183/ 020 20 pre-filled syringes EU/ 1/ 01/ 183/ 021 50 pre-filled syringes
EU/ 1/ 01/ 183/ 004 1 siringa mimlija minn qabel EU/ 1/ 01/ 183/ 005 10 siringi mimlijin minn qabel EU/ 1/ 01/ 183/ 020 20 siringi mimlijin minn qabel EU/ 1/ 01/ 183/ 021 50 siringi mimlijin minn qabel
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 5 micrograms/ 0.5 ml - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10
HBVAXPRO 5 mikrogrammi/ 0. 5 ml – doża waħda f’ siringa mimlija lesta b’ labra waħda separata - Pakkett ta ’ 1, 10
HBVAXPRO 5 micrograms/ 0.5 ml Suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogrammi/ 0. 5 ml Suspensjoni għall- injezzjoni f’ siringa mimlija lesta Vaċċin ta ’ l- Epatite B (rDNA)
Suspension for injection 1 single dose 0.5 ml pre-filled syringe with 1 separate needle 10 single dose 0.5 ml pre-filled syringes with 1 separate needle (for each syringe)
Suspensjoni għall- injezzjoni Doża waħda f’ siringa ta ’ 0. 5 ml mimlija lesta b’ labra waħda separata 10 dożi waħdanin f’ siringi ta ’ 0. 5 ml mimlijin lesti b’ labra waħda separata (għal kull siringa)
EU/ 1/ 01/ 183/ 022 1 pre-filled syringe EU/ 1/ 01/ 183/ 023 10 pre-filled syringes
EU/ 1/ 01/ 183/ 022 siringa waħda mimlija minn qabel EU/ 1/ 01/ 183/ 023 10 siringi mimlijin minn qabel
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 5 micrograms/ 0.5 ml - single dose pre-filled syringe with 2 separate needles - Pack of 1, 10
HBVAXPRO 5 mikrogrammi/ 0. 5 ml – siringa waħda mimlija minn qabel, b’ żewġ labriet separati – Pakkett ta ’ 1, 10
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
Antiġen rikombinanti tal- wiċċ tal- virus Epatite B *..............................
Suspension for injection 1 single dose 0.5 ml pre-filled syringe with 2 separate needles 10 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe)
Suspensjoni għall- injezzjoni Doża waħda ta ’ 0. 5 ml f’ siringa mimlija lesta, b’ żewġ labriet separati 10 dożi waħedhom ta ’ 0. 5 ml f’ siringi mimlijin lesti, b’ żewġ labriet separati (għal kull siringa)
EU/ 1/ 01/ 183/ 024 1 pre-filled syringe EU/ 1/ 01/ 183/ 025 10 pre-filled syringes
EU/ 1/ 01/ 183/ 024 siringa waħda mimlija minn qabel EU/ 1/ 01/ 183/ 025 10 siringi waħedhom mimlijin minn qabel
50 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
46 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 10 micrograms/ ml - single dose vial - Pack of 1, 10
HBVAXPRO 10 mikrogrammi/ ml – fjala b’ doża waħda - Pakkett ta ’ 1, 10
HBVAXPRO 10 micrograms/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogrammi/ ml Suspensjoni għall- injezzjoni Vaċċin ta ’ l- Epatite B (rDNA)
1 dose (1 ml) contains:
Doża 1 (1 ml) fiha:
10.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
10. 00 mikrogrammi Assorbiti fuq (0. 25 milligrammi Al+) ta ’ aluminium hydroxyphosphate sulfate, amorfu
Sodium chloride, borax and water for injections.
LISTA TA ’ SUSTANZI MHUX ATTIVI Sodium chloride, borax u ilma għall- injezzjonijiet.
10 single dose 1 ml vials.
Suspensjoni għall- injezzjoni Doża waħda ta ’ 1 ml fi fjala 10 dożi waħdanin ta ’ 1 ml fi fjali.
EU/ 1/ 01/ 183/ 007 1 vial EU/ 1/ 01/ 183/ 008 10 vials
EU/ 1/ 01/ 183/ 007 fjala waħda EU/ 1/ 01/ 183/ 008 10 fjali
53 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
HBVAXPRO 10 µg/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 10 µg/ ml Suspensjoni għall- injezzjoni Vaċċin ta ’ l- Epatite B (rDNA)
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 10 micrograms/ ml - single dose pre-filled syringe without needle - Pack of 1, 10
HBVAXPRO 10 mikrogrammi/ ml - doża waħda f’ siringa mimlija lesta mingħajr labra – Pakkett ta ’ 1, 10
HBVAXPRO 10 micrograms/ ml Suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogrammi/ ml Suspensjoni għall- injezzjoni f’ siringa mimlija lesta Vaċċin ta ’ l- Epatite B (rDNA)
Hepatitis B virus surface antigen, recombinant (HBsAg) *....................
Antiġen rikombinanti tal- wiċċ tal- virus Epatite B *..............................
10.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
10. 00 mikrogrammi Assorbiti fuq (0. 50 milligrammi Al+) ta ’ aluminium hydroxyphosphate sulfate, amorfu
Sodium chloride, borax and water for injections.
Sodium chloride, borax u ilma għall- injezzjonijiet
Suspension for injection 1 single dose 1 ml pre-filled syringe without needle 10 single dose 1 ml pre-filled syringes without needle
10 dożi waħdanin ta ’ 1 ml f’ siringi mimlijin lesti mingħajr labra.
Shake well before use.
Ħawwad sew qabel ma tuża..
55 8.
51 8.
EU/ 1/ 01/ 183/ 011 1 pre-filled syringe EU/ 1/ 01/ 183/ 013 10 pre-filled syringes
EU/ 1/ 01/ 183/ 011 1 siringa mimlija minn qabel EU/ 1/ 01/ 183/ 013 10 siringi mimlijin minn qabel
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
52 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 10 micrograms/ ml - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10
HBVAXPRO 10 mikrogrammi/ ml – siringa mimlija minn qabel b’ doża waħda, b’ labra waħda separata - Pakkett ta ’ 1, 10
HBVAXPRO 10 micrograms/ ml Suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogrammi/ ml Suspensjoni għall- injezzjoni f’ siringa mimlija minn qabel Vaċċin ta ’ l- Epatite B (rDNA)
Hepatitis B virus surface antigen, recombinant (HBsAg) *....................
Antiġen rikombinanti (HBsAg) tal- wiċċ tal- virus Epatite B *...............
10.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
10. 00 mikrogrammi Assorbiti fuq (0. 50milligrammi Al+) ta ’ aluminium hydroxyphosphate sulfate, amorfu
Suspension for injection 1 single dose 1 ml pre-filled syringe with 1 separate needle 10 single dose 1 ml pre-filled syringes with 1 separate needle (for each syringe)
Suspensjoni għall- injezzjoni Doża waħda ta’ 1 ml f’ siringa mimlija minn qabel b’ labra seperata 10 dożi waħedhom ta’ 1 ml f’ siringi mimlijin minn qabel b’ labra seperata (għal kull siringa)
57 8.
53 8.
EU/ 1/ 01/ 183/ 026 1 pre-filled syringe EU/ 1/ 01/ 183/ 027 10 pre-filled syringe
EU/ 1/ 01/ 183/ 026 siringa waħda mimlija minn qabel EU/ 1/ 01/ 183/ 027 10 siringi mimlijin minn qabel
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
54 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 10 micrograms/ ml - single dose pre-filled syringe with 2 separate needles - Pack of 1, 10
HBVAXPRO 10 mikrogrammi/ ml – siringa mimlija minn qabel b’ doża waħda, b’ żewġ labar separati - Pakkett ta ’ 1, 10
Suspension for injection 1 single dose 1 ml pre-filled syringe with 2 separate needles 10 single dose 1 ml pre-filled syringes with 2 separate needles (for each syringe)
Suspensjoni għall- injezzjoni Doża waħda ta’ 1 ml f’ siringa mimlija minn qabel b’ żewġ labar seperati 10 dożi waħedhom ta’ 1 ml f’ siringi mimlijin minn qabel b’ żewġ labar seperati (għal kull siringa)
59 8.
55 8.
EU/ 1/ 01/ 183/ 028 1 pre-filled syringe EU/ 1/ 01/ 183/ 029 10 pre-filled syringes
EU/ 1/ 01/ 183/ 028 siringa waħda mimlija minn qabel EU/ 1/ 01/ 183/ 029 10 siringi waħedhom mimlijin minn qabel
60 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
56 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
HBVAXPRO 10 µg/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 10 µg/ ml Suspensjoni għal injezzjoni
IM use
Jittieħed ġol- muskolu
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
57 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HBVAXPRO 40 micrograms/ ml - single dose vial - Pack of 1
HBVAXPRO – 40 mikrogramma/ ml – doża waħda fi fjala - Pakkett ta ’ 1
HBVAXPRO 40 micrograms/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 40 mikrogramma/ ml Suspensjoni għall- injezzjoni Vaċċin ta ’ l- Epatite B (rDNA)
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
Antiġen rikombinanti (HBsAg) tal- wiċċ tal- virus Epatite B *...............
40.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
40. 00 mikrogramma Assorbiti fuq (0. 50 milligrammi Al+) ta ’ aluminium hydroxyphosphate sulfate, amorfu
Suspension for injection 1 single dose 1 ml vial.
Suspensjoni għall- injezzjoni Doża waħda ta’ 1 ml fi fjala.
Store in a refrigerator Do not freeze
Tiffiżahx
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
59 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
HBVAXPRO 40 micrograms/ ml
HBVAXPRO 40 mikrogramma/ ml
HBVAXPRO 40 µg/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 40 µg/ ml Suspensjoni għal injezzjoni Vaċċin ta ’ l- Epatite B (rDNA)
65 PACKAGE LEAFLET:
61 FULJETT TA ’ TAGĦRIF:
HBVAXPRO 5 micrograms/ 0.5 ml, suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogrammi/ 0. 5 ml, suspensjoni għall- injezzjoni Vaċċin għall- Epatite B (rDNA)
Read all of this leaflet carefully before your child is vaccinated.
Aqra dan il- fuljett kollu qabel it- tifel/ tifla tiegħek jiġi/ tiġi vaċċinat/ a.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What HBVAXPRO 5 micrograms/ 0.5 ml is and what it is used for 2.
X' inhu HBVAXPRO 5 mikrogrammi/ 0. 5 ml u għalxiex jintuża 2.
Before you use HBVAXPRO 5 micrograms/ 0.5 ml 3.
Qabel ma ’ jittieħed HBVAXPRO 5 mikrogrammi/ 0. 5 ml 3.
How to use HBVAXPRO 5 micrograms/ 0.5 ml 4.
Kif għandu jittieħed HBVAXPRO 5 mikrogrammi/ 0. 5 ml 4.
How to store HBVAXPRO 5 micrograms/ 0.5 ml 6.
Kif taħżen HBVAXPRO 5 mikrogrammi/ 0. 5 ml 6.
WHAT HBVAXPRO 5 micrograms/ 0.5 ml IS AND WHAT IT IS USED FOR
1 X' INHU HBVAXPRO 5 mikrogrammi/ 0. 5 ml U GĦALXIEX JINTUŻA
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in children and adolescents (from birth trough 15 years of age) considered at risk of exposure to hepatitis B virus.
Il- vaċċin huwa intiż għall- immunizzazzjoni attiva kontra infezzjoni tal- virus epatite B ikkaġunata mis- subtipi kollha magħrufa fi tfal u adoloxxenti (mit- twelid sa l- età ta ’ 15- il sena) li huma kkunsidrati li qegħdin f' riskju ta ’ espożizzjoni għall - virus epatite B.
It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D does not occur in the absence of hepatitis B infection.
Huwa mistenni li l- epatite D tiġi evitata b’ immunizzazzjoni b’ HBVAXPRO billi l- epatite D ma tfeġġx fl- assenza ta ’ infezzjoni b’ epatite B.
The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.
Il- vaċċin ma jevitax infezzjoni kkaġunat minn aġenti oħrajn bħal epatite A, epatite Ċ, u epatite E u patoġeni oħrajn magħrufa li jinfettaw il- fwied.
BEFORE YOU USE HBVAXPRO 5 micrograms/ 0.5 ml
QABEL MA TUŻA HBVAXPRO 5 mikrogrammi/ 0. 5 ml
Do not use HBVAXPRO 5 micrograms/ 0.5 ml:
Tużax HBVAXPRO 5 mikrogrammi/ 0. 5 ml:
- if your child is allergic (hypersensitive) to hepatitis B surface antigen or to any of the other
- jekk it- tifel/ tifla tiegħek huwa/ hija allerġiku/ a (għadu/ għandha sensittività eċċessiva) għall -
ingredients of HBVAXPRO (see section 6.)
antiġen tal- wiċċ ta ’ l- epatite B jew xi ingredjent ieħor ta ’ HBVAXPRO (ara sezzjoni 6).
- if your child has a severe febrile illness
- jekk it- tifel/ tifla tiegħek għandu/ għandha deni qawwi
Using other vaccines:
Meta tieħu vaċċini oħra:
This vaccine can be administered simultaneously with hepatitis B immunoglobulin, at a separate injection site.
Dan il- vaċċin jista ’ jingħata flimkien ma ’ immunoglobulina ta ’ l- epatite B, f’ sit differenti ta ’ injezzjoni.
This vaccine can be used to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine.
Dan il- vaċċin jista ’ jintuża sabiex jitlesta kors ta ’ immunizzazzjoni primarju jew bħala doża ta ’ rafforzament f’ suġġetti li qabel ikunu ħadu vaċċin ieħor ta ’ l- epatite B.
This vaccine may be administered concomitantly with some other vaccines, using separate sites and syringes.
Dan il- vaċċin jista ’ jingħata flimkien ma ’ vaċċini oħrajn, f’ siti separati u b’ siringi differenti.
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk it- tifel/ tifla tiegħek qed/ qegħda tieħu jew ħa/ ħadet dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
HOW TO USE HBVAXPRO 5 micrograms/ 0.5 ml:
KIF GĦANDEK TIEĦU HBVAXPRO 5 mikrogrammi/ 0. 5 ml
Posology:
62 Pożoloġija:
The recommended dose for each injection (0.5 ml) is 5 micrograms for children and adolescents (birth through 15 years of age).
Id- doża rakkomandata għal kull injezzjoni (0. 5 ml) hija 5 mikrogrammi għat- tfal u l- adoloxxenti (mit - twelid sa l- età ta ’ 15- il sena).
A course of vaccination should include at least three injections.
Kors ta ’ vaċċinazzjoni għandu jinkludi ta ’ l- anqas tliet injezzjonijiet.
Two immunisation schedules can be recommended:
Jistgħu jiġu rakkomandati żewġ skedi ta ’ immunizzazzjoni:
- two injections with an interval of one month followed by a third injection 6 months after the first
- żewġ injezzjonijiet b’ intervall ta ’ xahar segwiti bit- tielet injezzjoni 6 xhur wara l- ewwel waħda
administration (0,1,6 months).
(0, 1, 6 xhur).
- three injections with an interval of one month and a fourth dose 1 year later, if a rapid immunity is
- tliet injezzjonijiet b’ intervall ta ’ xahar u r- raba ’ doża sena wara, jekk ikun hemm bżonn ta ’
requested (0,1,2,12 months).
immunità ta ’ malajr (0, 1, 2, 12- il xahar).
In case of a recent exposure to the hepatitis B virus, a first dose of HBVAXPRO together with the appropriate dose of immunoglobulin can be given.
F’ każ ta ’ espożizzjoni reċenti għall- virus ta ’ l- epatite B, l- ewwel doża ta ’ HBVAXPRO tista ’ tingħata flimkien ma ’ doża xierqa ta ’ immunoglobulina.
Some local vaccination schedules currently include recommendations for a booster dose.
Xi skedi lokali ta ’ vaċċinazzjoni attwalment jinkludu rakkomandazzjonijiet għal doża ta ’ rafforzament.
Your doctor or pharmacist will inform you if a booster dose should be given.
It- tabib jew l- ispiżjar tiegħek għandu jinfurmak jekk għandhiex tingħata doża ta ’ rafforzament
Method of administration:
Kif Għandu Jingħata:
It should be well shaken until a slightly opaque white suspension is obtained.
Il- vaċċin għandu jitħallat sew sabiex tinkiseb suspensjoni bajda ftit opaka.
The doctor will give the vaccine as an injection into muscle.
It- tabib tiegħek se jagħti l- vaċċin bħala injezzjoni ġol- muskolu.
The upper side of the thigh is the preferred site for injection in neonates and infants.
Il- parti ta ’ fuq tal- koxxa huwa l- post ippreferut fejn tingħata l- injezzjoni fit- trabi li għadhom jitwieldu u tfal żgħar.
The upper arm muscle is the preferred site for injection in children and adolescents.
In- naħa ta ’ fuq tal - muskolu tad- driegħ huwa l- lok preferut fi tfal u adoloxxenti.
This vaccine should never be given into a vein.
Dan il- vaċċin qatt m' għandu jingħata ġol- vina.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia (diminution of blood platelets) or to persons at risk of haemorrhage.
F' każijiet ta ’ eċċezzjoni, il- vaċċin jista ’ jingħata taħt il- ġilda f’ pazjenti bi tromboċitopenija (li għandhom tnaqqis fl- għadd ta ’ plejtlets) jew f’ persuni li qegħdin f’ riskju ta ’ emorraġija.
If you forget one dose of HBVAXPRO 5 micrograms/ 0.5 ml:
Jekk tinsa doża waħda ta ’ HBVAXPRO 5 mikrogrammi/ 0. 5 ml:
If you miss a scheduled injection, your doctor will decide when to give the missed dose.
Jekk tinsa doża skedata, it- tabib tiegħek ser jiddeċiedi meta għandek tieħu d- doża li tkun tlift.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek iktar mistoqsijiet dwar kif tuża dan il- prodott, saqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, HBVAXPRO can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, HBVAXPRO jista ’ jikkawża xi effetti oħrajn.
As with other hepatitis B vaccines, in many instances, the causal relationship of side effects to the vaccine has not been established.
Bħal fil- każ ta ’ vaċċini oħra ta ’ l- epatite B, f’ ħafna każijiet, ir- relazzjoni kawża- effett bejn l- effetti sekondarji u l- vaċċin għadhom ma ġewx stabbiliti.
HBVAXPRO is generally well tolerated.
Ġeneralment HBVAXPRO jiġi ttollerat tajjeb.
The most common side effects seen are injection-site reactions: soreness, redness and hardening.
L- effetti sekondarji l- iktar komuni jinkludu reazzonijiet fis- sit ta ’ l- injezzjoni bħal ħruq, ħmura u għebusija fis- sit.
67 Other side effects are reported very rarely: low platelet count, lymph node disease, allergic reactions, nervous system disorders such as pins and needles, facial paralysis, nerve inflammations including Guillain-Barre Syndrome, inflammation of the nerve of the eye that leads to impaired vision, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, convulsions, headache, dizziness and fainting, low blood pressure, blood vessel inflammation, asthma-like symptoms, vomiting, nausea, diarrhoea, abdominal pain, skin reactions such as eczema, rash, hair loss, itching, hives and skin blistering, joint pain, arthritis, muscle pain, pain in extremity, fatigue, fever, vague illness, flu-like symptoms and elevations of liver enzymes.
63 reazzjonijiet tal- ġilda bħall- ekżema, raxx, telfien tax- xahar, ħakk, urtikarja u bżieżaq fil- ġilda, uġigħ fil- ġogi, artrite, uġigħ fil- muskoli, uġigħ fl- estremitajiet, għeja, deni, telqa, sintomi bħal influwenza u livelli elevati ta ’ enżimi fil- fwied.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk dawn l- effetti sekondarji jsiru serji, jew jekk tinduna b’ xi effetti oħrajn li mhux mniżżlin f’ dan il - fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE HBVAXPRO 5 micrograms/ 0.5 ml
KIF TAĦŻEN HBVAXPRO 5 mikrogrammi/ 0. 5 ml
Do not use HBVAXPRO after the expiry date which is stated on the label.
Tużax HBVAXPRO wara d- data li jiskadi li tidher fuq it- tikketta.
Store in a refrigerator (2 °C – 8 °C) Do not freeze
Aħżen fil- friġġ f’ temperatura ta ’ bejn (2oC – 8oC) Tagħmlux fil- friża
What HBVAXPRO 5 micrograms/ 0.5 ml contains
X’ fih HBVAXPRO 5 mikrogrammi/ 0. 5 ml:
The active substance is, for one dose of 0.5 ml:
Għal doża waħda ta ’ 0. 5 ml:
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
Antiġen rikombinanti (HBsAg) tal- wiċċ tal- virus ta ’ Epatite B *..........
5.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)
5. 00 mikrogramma Assorbiti fuq (0. 25 milligrammi Al+) ta ’ aluminium hydroxyphosphate sulfate, amorfu
The other ingredients are sodium chloride, borax and water for injections.
L- ingredjenti l- oħra huma sodium chloride, borax u ilma għall- injezzjonijiet
What HBVAXPRO 5 micrograms/ 0.5 ml looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Each dose contains 0.5 ml of suspension for injection in a vial.
Kull doża fiha 0. 5 ml ta ’ suspensjoni għall- injezzjoni fi fjala.
Pack sizes of 1 and 10 vials without syringe/ needle.
Daqs tal- pakketti ta ’ fjala waħda u 10 mingħajr siringa/ labra.
Pack size of 1 vial with syringe and needle.
Pakkett ta ’ fjala waħda b’ siringa u labra.
Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq older:
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F- 69007 Lyon, Franza
Manufacturer Responsible for Batch Release:
Manifattur Responsibbli għall- Ħruġ tal- Lott:
Merck Sharp and Dohme, B. V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Merck Sharp and Dohme, B. V., Waarderweg, 39, 2031 BN Haarlem, L- Olanda
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
This leaflet was last approved in ………….
Dan il- fuljett kien approvat l- aħħar f ’ …….
69 PACKAGE LEAFLET:
65 FULJETT TA ’ TAGĦRIF:
HBVAXPRO 5 micrograms/ 0.5 ml, suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogrammi/ 0. 5 ml, suspensjoni għall- injezzjoni f’ siringa mimlija minn qabel Vaċċin għall- Epatite B (rDNA)
WHAT IS HBVAXPRO 5 micrograms/ 0.5 ml AND WHAT IT IS USED FOR
1 X' INHU HBVAXPRO 5 mikrogrammi/ 0. 5 ml U GĦALXIEX JINTUŻA
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in children and adolescents (from birth through 15 years of age) considered at risk of exposure to hepatitis B virus.
Il- vaċċin huwa intiż għall- immunizzazzjoni attiva kontra infezzjoni tal- virus epatite B ikkaġunata mis- subtipi kollha magħrufa fi tfal u adoloxxenti (mit- twelid sa l- età ta ’ 15- il sena) li huma kkunsidrati li qegħdin f' riskju ta ’ espożizzjoni għall - virus epatite B.
- if your child has a severe febrile illness
- jekk it- tifel/ tifla tiegħek għandu/ għandha deni qawwi.
HOW TO USE HBVAXPRO 5 micrograms/ 0.5 ml
KIF GĦANDEK TIEĦU HBVAXPRO 5 mikrogrammi/ 0. 5 ml
Posology:
66 Pożoloġija:
The needle is attached by twisting in clockwise direction, until the needle fits securely on the syringe.
Il- labra titwaħħal billi tiddawwar kif idur l- arloġġ, sakemm il- labra tidħol sew fis- siringa.
The most common side effects seen are injection-site reactions: soreness, redness and hardening.
L- effetti sekondarji l- iktar komuni jinkludu reazzonijiet fis- sit ta ’ l - injezzjoni bħal ħruq, ħmura u għebusija fis- sit.
71 Other side effects are reported very rarely: low platelet count, lymph node disease, allergic reactions, nervous system disorders such as pins and needles, facial paralysis, nerve inflammations including Guillain-Barre Syndrome, inflammation of the nerve of the eye that leads to impaired vision, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, convulsions, headache, dizziness and fainting, low blood pressure, blood vessel inflammation, asthma-like symptoms, vomiting, nausea, diarrhoea, abdominal pain, skin reactions such as eczema, rash, hair loss, itching, hives and skin blistering, joint pain, arthritis, muscle pain, pain in extremity, fatigue, fever, vague illness, flu-like symptoms and elevations of liver enzymes.
67 fil- ġogi, artrite, uġigħ fil- muskoli, uġigħ fl- estremitajiet, għeja, deni, telqa, sintomi bħal influwenza u livelli elevati ta ’ enżimi fil- fwied.
5.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)
Antiġen rikombinanti (HBsAg) tal- wiċċ tal- virus ta ’ Epatite B *............ 5. 00 mikrogramma Assorbiti fuq (0. 25 milligrammi Al+) ta ’ aluminium hydroxyphosphate sulfate, amorfu
The other ingredients are sodium chloride, borax and water for injections.
L- ingredjenti l- oħra huma sodium chloride, borax u ilma għall- injezzjonijiet.
What HBVAXPRO 5 micrograms/ 0.5 ml looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Each dose contains 0.5 ml of suspension for injection in a syringe.
Kull doża fiha 0. 5 ml ta ’ suspensjoni għall- injezzjoni f’ siringa.
Pack sizes of 1, 10, 20 and 50 pre-filled syringes without needle, Pack sizes of 1 and 10 pre-filled syringes with 1 or 2 separate needles.
Pakketti ta ’ 1 u 10 ta ’ siringi mimlija minn qabel b’ siringa waħda jew tnejn.
This leaflet was last approved in ………….
Dan il- fuljett kien approvat l- aħħar f ’.......
73 PACKAGE LEAFLET:
69 FULJETT TA ’ TAGĦRIF:
HBVAXPRO 10 micrograms/ ml, suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogrammi / ml, suspensjoni għall- injezzjoni Vaċċin għall- Epatite B (rDNA)
Read all of this leaflet carefully before you are vaccinated.
Aqra dan il- fuljett kollu qabel ma tiġi vaċċinat/ a.
What HBVAXPRO 10 micrograms/ ml is and what it is used for 2.
X' inhu HBVAXPRO 10 mikrogrammi/ ml u għalxiex jintuża 2.
Before you use HBVAXPRO 10 micrograms/ ml 3.
Qabel ma ’ jittieħed HBVAXPRO 10 mikrogrammi/ ml 3.
How to use HBVAXPRO 10 micrograms/ ml 4.
Kif għandu jittieħed HBVAXPRO 10 mikrogrammi/ ml 4.
How to store HBVAXPRO 10 micrograms/ ml 6.
Kif taħżen HBVAXPRO 10 mikrogrammi/ ml 6.
WHAT HBVAXPRO 10 micrograms/ ml IS AND WHAT IT IS USED FOR
1 X' INHU HBVAXPRO 10 MIKROGRAMMI/ ML U GĦALXIEX JINTUŻA
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in adults and adolescents (16 years of age and older) considered at risk of exposure to hepatitis B virus.
Il- vaċċin huwa intiż għall- immunizzazzjoni attiva kontra infezzjoni tal- virus epatite B ikkaġunata mis - subtipi kollha magħrufa f’ adulti u adoloxxenti (minn 16- il sena u ikbar) li huma kkunsidrati li qegħdin f' riskju ta ’ espożizzjoni għall - virus epatite B.
BEFORE YOU USE HBVAXPRO 10 micrograms/ ml
QABEL MA TUŻA HBVAXPRO 10 mikrogrammi / ml
Do not use HBVAXPRO 10 micrograms/ ml:
Tużax HBVAXPRO 10 mikrogrammi / ml:
- if you are allergic (hypersensitive) to hepatitis B surface antigen or to any of the other ingredients of
- jekk int allerġiku/ a (għandek sensittività eċċessiva) għall- antiġen tal- wiċċ ta ’ l- epatite B jew xi
HBVAXPRO (see section 6.)
ingredjent ieħor ta ’ HBVAXPRO (ara sezzjoni 6).
- if you have a severe febrile illness
- jekk għandek deni qawwi.
Take special care with HBVAXPRO 10 micrograms/ ml:
Agħmel attenzjoni speċjali b’ HBVAXPRO 10 mikrogrammi / ml:
Pregnancy and Breast-feeding:
Tqala u Treddigħ:
Caution should be exercised when prescribing to pregnant women.
Il- preskrizzjoni lin- nisa tqal għandha ssir b’ kawtela.
Breast-feeding is not a contraindication.
It- treddigħ mhux kontra- indikat.
Some of the rare effects may affect the ability to drive or operate machinery.
Sewqan u tħaddim ta ’ magni Xi wħud mill- effetti rari jistgħu jaffettwaw il- ħila biex issuq jew jew tħaddem magni.
Using other vaccines:
70 Meta tieħu vaċċini oħra:
74 This vaccine can be administered simultaneously with hepatitis B immunoglobulin, at a separate injection site.
Dan il- vaċċin jista ’ jingħata flimkien ma ’ immunoglobulina ta ’ l- epatite B, f’ sit differenti ta ’ injezzjoni.
This vaccine can be administered concomitantly with other vaccines, using separate sites and syringes.
Dan il- vaċċin jista ’ jingħata flimkien ma ’ vaċċini oħrajn, f’ siti separati u b’ siringi differenti.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk it- tifel/ tifla tiegħek qed/ qegħda tieħu jew ħa/ ħadet dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
HOW TO USE HBVAXPRO 10 micrograms/ ml
KIF GĦANDEK TIEĦU HBVAXPRO 10 mikrogrammi / ml
The recommended dose for each injection (1 ml) is 10 micrograms for adults and adolescents (16 years of age and older).
Id- doża rakkomandata għal kull injezzjoni (1 ml) hija 10 mikrogrammi għall- adulti u l- adoloxxenti (minn 16- il sena ‘ l fuq).
A course of vaccination should include three injections.
Kors ta ’ vaċċinazzjoni għandu jinkludi tliet injezzjonijiet.
- two injections with an interval of one month followed by a third injection 6 months after the
- żewġ injezzjonijiet b’ intervall ta ’ xahar segwiti bit- tielet injezzjoni 6 xhur wara l- ewwel waħda
first administration (0,1,6 months)
(0, 1, 6 xhur).
The upper arm muscle is the preferred site for injection in adults and adolescents.
In- naħa ta ’ fuq tal- muskolu tad- driegħ huwa l- lok preferut fl- adulti u adoloxxenti.
If you forget one dose of HBVAXPRO 10 micrograms/ ml:
Jekk tinsa doża waħda ta ’ HBVAXPRO 10 mikrogrammi/ ml:
If you missed a scheduled injection, your doctor will decide when to give the missed dose.
Jekk tinsa doża skedata, it- tabib tiegħek ser jiddeċiedi meta għandek tieħu d- doża li tkun tlift.
75 As with other hepatitis B vaccines, in many instances, the causal relationship of side effects to the vaccine has not been established.
Bħal fil- każ ta ’ vaċċini oħra ta ’ l- epatite B, f’ ħafna każijiet, ir- relazzjoni kawża- effett bejn l- effetti sekondarji u l- vaċċin għadhom ma ġewx stabbiliti.
HBVAXPRO is generally well tolerated.
71 Ġeneralment HBVAXPRO jiġi ttollerat tajjeb.
Other side effects are reported very rarely: low platelet count, lymph node disease, allergic reactions, nervous system disorders such as pins and needles, facial paralysis, nerve inflammations including Guillain-Barre Syndrome, inflammation of the nerve of the eye that leads to impaired vision, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, convulsions, headache, dizziness and fainting, low blood pressure, blood vessel inflammation, asthma-like symptoms, vomiting, nausea, diarrhoea, abdominal pain, skin reactions such as eczema, rash, hair loss, itching, hives and skin blistering, joint pain, arthritis, muscle pain, pain in extremity, fatigue, fever, vague illness, flu-like symptoms and elevations of liver enzymes.
Reazzjonijiet sekondarji oħra li jiġu rrapurati b’ mod rari ħafna: għadd baxx tal - plejtlets, mard tan- nodi tal- limfi, reazzjonijiet allerġiċi, disturbi fis- sistema nervuża bħal tnemnim, paraliżi tal- wiċċ, infjammazzjoni tan- nervituri inkluż is- Sindromu ta ’ Guillain- Barre, infjammazzjoni tan- nervituri ta ’ l- għajn li jwassal għal viżta mnaqqsa, infjammazzjoni tal- moħħ, taħrix ta ’ sklerożi multipla, sklerożi multipla, konvulżjonijiet, uġigħ ta ’ ras, sturdament u ħass ħażin, pressjoni baxxa, infjammazzjoni tal- vini, sintomi bħall- ażma, remettar, nawżja, dearrea, uġiegħ addominali, reazzjonijiet tal- ġilda bħall- ekżema, raxx, telfien tax- xahar, ħakk, urtikarja u bżieżaq fil- ġilda, uġigħ fil- ġogi, artrite, uġigħ fil- muskoli, uġigħ fl- estremitajiet, għeja, deni, telqa, sintomi bħal influwenza u livelli elevati ta ’ enżimi fil- fwied.
HOW TO STORE HBVAXPRO 10 micrograms/ ml
KIF TAĦŻEN HBVAXPRO 10 mikrogrammi/ ml
What HBVAXPRO 10 micrograms/ ml contains
X’ fih HBVAXPRO 10 mikrogrammi/ ml:
The active substance is, for one dose of 1 ml:
Għal doża waħda ta ’ 1 ml:
10.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
10. 00 mikrogramma Assorbiti fuq (0. 50 milligrammi Al+) ta ’ aluminium hydroxyphosphate sulfate, amorfu
What HBVAXPRO 10 micrograms/ ml looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Each dose contains 1 ml of suspension for injection in a vial.
Kull doża fiha 1 ml ta ’ suspensjoni għall- injezzjoni fi fjala.
Pack sizes of 1 and 10 vials.
Pakketti ta ’ 1 u 10 fjali.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
76 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Sanofi Pasteur MSD Ltd, Tel: +3531.468.5600 Ísland:
Sanofi Pasteur MSD Ltd, Tel: +3531468. 5600 Ísland:
Sanofi Pasteur MSD, Puh/ Tel: +358.9.565.88.30 Sverige:
Sanofi Pasteur MSD, Puh/ Tel: +358. 9. 565. 88. 30Sverige:
77 PACKAGE LEAFLET:
73 FULJETT TA ’ TAGĦRIF:
HBVAXPRO 10 micrograms/ ml, suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogrammi / ml, suspensjoni għall- injezzjoni f’ siringa mimlija minn qabel Vaċċin għall- Epatite B (rDNA)
- if you are allergic (hypersensitive) to hepatitis B surface antigen or to any of the other ingredients
- jekk int allerġiku/ a (għandek sensittività eċċessiva) għall- antiġen tal- wiċċ ta ’ l- epatite B jew xi
of HBVAXPRO (see section 6.)
ingredjent ieħor ta ’ HBVAXPRO (ara sezzjoni 6).
Take special care with HBVAXPRO 10 micrograms/ ml:
Agħmel attenzjoni speċjali b’ HBVAXPRO 10 mikrogrammi/ ml:
Some of the rare effects may affect the ability to drive or operate machinery.
Xi wħud mill- effetti rari jistgħu jaffettwaw il- ħila biex issuq jew jew tħaddem magni.
Using other vaccines:
74 Meta tieħu vaċċini oħra:
78 This vaccine can be administered simultaneously with hepatitis B immunoglobulin, at a separate injection site.
Dan il- vaċċin jista ’ jingħata flimkien ma ’ immunoglobulina ta ’ l- epatite B, f’ sit differenti ta ’ injezzjoni.
A course of vaccination should include at least three injections.
Kors ta ’ vaċċinazzjoni għandu jinkludi mill- inqas tliet injezzjonijiet.
administration (0,1,6 months)
(0, 1, 6 xhur).
79 Like all medicines, HBVAXPRO can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, HBVAXPRO jista ’ jikkawża xi effetti oħrajn.
As with other hepatitis B vaccines, in many instances, the causal relationship of side effects to the vaccine has not been established.
75 Bħal fil- każ ta ’ vaċċini oħra ta ’ l- epatite B, f’ ħafna każijiet, ir- relazzjoni kawża- effett bejn l- effetti sekondarji u l- vaċċin għadhom ma ġewx stabbiliti.
Each dose contains 1 ml of suspension for injection in a syringe.
Kull doża fiha 1 ml ta ’ suspensjoni għall- injezzjoni f’ siringa.
Pack sizes of 1 and 10 pre-filled syringes without needle, or with 1 or 2 separate needles.
Pakketti ta ’ 1 u 10 siringi bla labra, jew b’ labra waħda jew tnejn separati.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
80 Manufacturer Responsible for Batch Release:
Manifattur Responsibbli għall- Ħruġ tal- Lott:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
76 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
This leaflet was last approved in …………..
Dan il- fuljett kien approvat l- aħħar f ’...........
81 PACKAGE LEAFLET:
77 FULJETT TA ’ TAGĦRIF:
HBVAXPRO 40 micrograms/ ml, suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 40 mikrogrammi / ml, suspensjoni għall- injezzjoni Vaċċin għall- Epatite B (rDNA)
What HBVAXPRO 40 micrograms/ ml is and what it is used for 2.
X' inhu HBVAXPRO 40 mikrogrammi/ ml u għalxiex jintuża 2.
Before you use HBVAXPRO 40 micrograms/ ml 3.
Qabel ma ’ jittieħed HBVAXPRO 40 mikrogrammi/ ml 3.
How to use HBVAXPRO 40 micrograms/ ml 4.
Kif għandu jittieħed HBVAXPRO 40 mikrogrammi/ ml 4.
How to store HBVAXPRO 40 micrograms/ ml 6.
Kif taħżen HBVAXPRO 40 mikrogrammi/ ml 6.
WHAT HBVAXPRO 40 micrograms/ ml IS AND WHAT IT IS USED FOR
1 X' INHU HBVAXPRO 40 mikrogrammi / ml U GĦALXIEX JINTUŻA
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients.
Il- vaċċin huwa intiż għall- immunizzazzjoni attiva kontra infezzjoni tal- virus epatite B ikkaġunata mis - subtipi kollha magħrufa f’ adulti qabel u waqt id- dijalisi.
It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Huwa mistenni li l- epatite D tiġi evitata b’ immunizzazzjoni b’ HBVAXPRO billi l- epatite D ma tfeġġx fl- assenza ta ’ infezzjoni b’ epatite B.
BEFORE YOU USE HBVAXPRO 40 micrograms / ml
QABEL MA TUŻA HBVAXPRO 40 mikrogrammi / ml
Do not use HBVAXPRO 40 micrograms/ ml:
Tużax HBVAXPRO 40 mikrogrammi / ml:
- if you have a severe febrile illness
- jekk għandek deni qawwi
Take special care with HBVAXPRO 40 micrograms/ ml:
Agħmel attenzjoni speċjali b’ HBVAXPRO 40 mikrogrammi/ ml:
Using other vaccines:
78 Meta tieħu vaċċini oħra:
82 This vaccine can be administered simultaneously with hepatitis B immunoglobulin, at a separate injection site.
Dan il- vaċċin jista ’ jingħata flimkien ma ’ immunoglobulina ta ’ l- epatite B, f’ sit differenti ta ’ injezzjoni.
HOW TO USE HBVAXPRO 40 micrograms/ ml
KIF GĦANDEK TIEĦU HBVAXPRO 40 mikrogrammi / ml
The recommended dose for each injection (1 ml) is 40 micrograms for predialysis and dialysis adult patients
Id- doża rakkomandata għal kull injezzjoni (1 ml) hija 40 mikrogrammi għall- adulti qabel u waqt id - dijalisi.
The schedule is two injections with an interval of one month followed by a third injection 6 months after the first administration (0,1,6 months).
L- iskeda hija żewġ injezzjonijiet b’ intervall ta ’ xahar segwiti bit- tielet injezzjoni 6 xhur wara l- ewwel waħda (0, 1, 6 xhur).
A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen is less than 10 IU/ l.
Jekk il- livell ta ’ antikorpi kontra l- antiġen tal- wiċċ tal- virus ta ’ l- epatite B jkun inqas minn 10 IU/ l, trid tiġi kkonsidrata doża ta ’ rafforzament.
The upper arm muscle is the preferred site for injection in adults.
In- naħa ta ’ fuq tal- muskolu tad- driegħ huwa l- lok preferut fl- adulti.
If you forget one dose of HBVAXPRO 40 micrograms/ ml:
Jekk tinsa doża waħda ta ’ HBVAXPRO 40 mikrogrammi/ ml:
83 Other side effects are reported very rarely: low platelet count, lymph node disease, allergic reactions, nervous system disorders such as pins and needles, facial paralysis, nerve inflammations including Guillain-Barre Syndrome, inflammation of the nerve of the eye that leads to impaired vision, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, convulsions, headache, dizziness and fainting, low blood pressure, blood vessel inflammation, asthma-like symptoms, vomiting, nausea, diarrhoea, abdominal pain, skin reactions such as eczema, rash, hair loss, itching, hives and skin blistering, joint pain, arthritis, muscle pain, pain in extremity, fatigue, fever, vague illness, flu-like symptoms and elevations of liver enzymes.
79 tan- nervituri ta ’ l- għajn li jwassal għal viżta mnaqqsa, infjammazzjoni tal- moħħ, taħrix ta ’ sklerożi multipla, sklerożi multipla, konvulżjonijiet, uġigħ ta ’ ras, sturdament u ħass ħażin, pressjoni baxxa, infjammazzjoni tal- vini, sintomi bħall- ażma, remettar, nawżja, dearrea, uġiegħ addominali, reazzjonijiet tal- ġilda bħall- ekżema, raxx, telfien tax- xahar, ħakk, urtikarja u bżieżaq fil- ġilda, uġigħ fil- ġogi, artrite, uġigħ fil- muskoli, uġigħ fl- estremitajiet, għeja, deni, telqa, sintomi bħal influwenza u livelli elevati ta ’ enżimi fil- fwied.
HOW TO STORE HBVAXPRO 40 micrograms/ ml
KIF TAĦŻEN HBVAXPRO 40 mikrogrammi/ ml
What HBVAXPRO 40 micrograms/ ml contains
X’ fih HBVAXPRO 40 mikrogrammi/ ml:
What HBVAXPRO 40 micrograms/ ml looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Pack size of 1 vial.
Pakketti ta ’ fjala waħda.
This leaflet was last approved in ………….
Dan il- fuljett kien approvat l- aħħar f ’ …..
HELICOBACTER TEST INFAI
T- TEST HELICOBACTER INFAI
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR). Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is Helicobacter Test INFAI?
X’ inhu t- Test Helicobacter INFAI?
Helicobacter Test INFAI is a diagnostic test.
It- Test Helicobacter INFAI huwa test dijanjostiku.
It is available as a jar containing a powder to be made up into a solution for drinking.
Huwa jiġi bħala vażett li jkun fih trab li jitħallat f’ soluzzjoni għax- xorb.
The powder is the active substance 13C-urea (45 mg for children or 75 mg for adults).
It- trab huwa s- sustanza attiva 13C- urea (45 mg għat- tfal jew 75 mg għall - adulti).
What is Helicobacter Test INFAI used for?
Għal xiex jintuża t- Test Helicobacter INFAI?
Helicobacter Test INFAI is used to diagnose Helicobacter pylori infection in the stomach and duodenum (the part of the gut just below the stomach).
It- Test Helicobacter INFAI jintuża biex tiġi dijanjotizzata infezzjoni Helicobacter pylori fl- istonku u d- duwodenu (il- parti tal- musrana eżatt taħt l- istonku).
H. pylori is a bacterium that is a factor in diseases such as dyspepsia (heartburn, bloating and nausea), gastritis (inflammation of the stomach), and peptic ulcer disease (ulcers in the stomach or the duodenum).
H. pylori huwa batterju li huwa fattur f’ mard bħal dispepsja (ħruq ta ’ stonku, tinfiħ u nawżja), gastrite (infjammazzjoni ta ’ l- istonku) u mard ta ’ ulċeri peptiċi (ulċeri fl- istonku jew fid- duwodenu).
Helicobacter Test INFAI can be used to test adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years.
It- Test Helicobacter INFAI jista ’ jintuża biex jittestja lill- adulti, adolexxenti bi probabbiltà li għandhom mard ta ’ ulċeri peptiċi, u tfal ta ’ etajiet minn tlieta sa 11- il sena.
It can only be used in children when invasive tests (taking a sample from the stomach using a probe) cannot be carried out or have given questionable results, or to check that H. pylori has been eliminated after a specific treatment to clear up the infection.
Jista ’ jintuża fit- tfal biss meta ma jkunux jistgħu jsiru testijiet invażivi (it- teħid ta ’ kampjun mill- istonku bl- użu ta ’ sonda) jew meta dawn jagħtu riżultati dubjużi, jew biex jiġi iċċekkjat li H. pylori ġie eliminat wara kura speċifika biex jelimina l- infezzjoni.
How is Helicobacter Test INFAI used?
Kif jintuża t- Test Helicobacter INFAI?
Helicobacter Test INFAI is a breath test: breath samples are collected, which are then sent out for analysis to a specialised laboratory.
It- Test Helicobacter INFAI huwa test tan- nifs: jinġabru kampjuni tan- nifs, li imbagħad jintbagħtu għal analiżi fl- laboratorju speċjalizzat.
To carry out the test, the patient must collect four samples, two before taking Helicobacter Test INFAI and two thereafter.
Biex isir it- test, il- pazjent jeħtieġ li jiġbor erba ’ kampjuni, tnejn qabel jieħu t- Test Helicobacter INFAI u tnejn wara.
The patient should not eat for at least six hours, preferably overnight, before taking the test.
Il- pazjent għandu jibqa ’ sajjem għal ta ’ l- inqas sitt sigħat, preferibbilment wara lejl, qabel ma jagħmel it- test.
Firstly, the patient collects two breath samples, using the tubes or bags supplied with Helicobacter Test INFAI.
L- ewwelnett, il- pazjent jiġbor żewġ kampjuni tan- nifs, permezz ta ’ l- użu ta ’ tubi jew boroż fornuti mat- Test Helicobacter INFAI.
The patient then takes a ‘ test meal’ (either 200 ml of pure orange juice or 1 g of citric acid dissolved in 200 ml water), followed by the solution of Helicobacter Test INFAI dissolved in water.
Il- pazjent imbagħad jieħu ‘ ikla tat- test ’ (jew 200 ml ta ’ meraq tal- larinġ pur jew gramma ta ’ aċidu ċitriku maħlul f’ 200 ml ilma), segwita minn soluzzjoni tat- Test Helicobacter INFAI maħlul fl- ilma.
Finally, 30 minutes after drinking the solution, the patient collects a further two breath samples.
Fl- aħħarnett, 30 minuta wara li jixrob is - soluzzjoni, il- pazjent jiġbor żewġ kampjuni tan- nifs oħra.
In children aged three to 11 years, the ‘ test meal’ should be 100 ml of pure orange juice.
Fi tfal ta ’ etajiet bejn tlieta sa 11- il sena, l - ‘ ikla tat- test ’ għandha tkun 100 ml ta ’ meraq tal- larinġ pur.
For full information on how the test is carried out, see the Package Leaflet.
Għal tagħrif sħiħ fuq kif isir it- test, ara l - Fuljett ta ’ Tagħrif.