qanastek/EMEA-V3 huggingface dataset:
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins there was no effect on seroconversion rates.
Madankollu, meta t- tilqim monovalenti ta ’ l- epatite A u l- epatite B ingħataw flimkien ma ’ immunoglobulini speċifiċi, ma kien hemm l- ebda effett fuq ir- rati tas- serokonverżjoni.
Concomitant immunoglobulin administration may result in lower antibody titres.
L- amministrazzjoni ta ’ tilqim flimkien ma ’ immunoglobulini jista ’ jirriżulta f’ livelli ta ’ titri ta 'l- antikorpi aktar baxxi.
When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV/ Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1)
Meta Ambirix ingħata flimkien, iżda bħala injezzjoni separata, ma ’ vaċċin kombinat kontra d- difterite, tetnu, pertussis aċellulari, poljomelite inattivat u Haemophilus influenzae tat- tip b (DTPa- IPV/ Hib) jew ma ’ vaċċin kombinat kontra l- Ġidri, Ħożba u Rubella fit- tieni sena mit- twelid, ir- rispons immuni għall- antiġeni kollha kien sodisfaċenti (ara sezzjoni 5. 1)
Concomitant administration of Ambirix and other vaccines than those listed above has not been studied.
L- effett ta ’ Ambirix, meta jingħata flimkien ma ’ tilqim ieħor minbarra dawk li huma msemmija hawn fuq ma ġiex studjat.
It is advised that Ambirix should not be administered at the same time as other vaccines unless absolutely necessary.
Huwa rakkomandat li Ambirix ma jingħatax fl- istess ħin ma ’ tilqim ieħor sakemm dan ma jkunx assolutament meħtieġ.
Concomitant vaccines should always be administered at separate injection sites and preferably into different limbs.
Tilqim li jingħata flimkien għandu dejjem jingħata f`postijiet ta ’ injezzjoni differenti u preferibbilment fid- driegħ jew f’ riġlejn differenti.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Wieħed jista ’ jistenna li f' pazjenti li qiegħdin jieħdu kura immunosoppressiva jew f' pazjenti li għandhom immunodefiċjenza, ir- rispons mixtieq jista ’ ma jintlaħaqx.
4 The effect of Ambirix on foetal development has not been assessed.
4 Tqala
Ambirix should not be used during pregnancy unless it is clearly necessary.
Ambirix m’ għandux jintuża waqt it - tqala jekk m’ hemmx bżonn ċar.
The effect on breastfed infants of Ambirix administered to the mothers has not been evaluated in clinical studies.
L- effett fuq trabi li qed jieħdu l- ħalib ta 'l- omm li ħadet Ambirix ma ġiex stmat fi studji kliniċi.
Ambirix should not be used during lactation unless it is clearly necessary.
Ambirix m’ għandux jintuża waqt it- treddigħ jekk m’ hemmx bżonn ċar.
Drowsiness and dizziness can sometimes occur and may affect the ability to drive and use machines.
Jista ’ jkun hemm telqa u sturdament li jistgħu jaffettwaw il- ħila ta ’ sewqan u l- użu ta ’ magni.
The current formulation of Ambirix does not contain thiomersal (an organomercuric compound) or any preservative.
Il- formulazzjoni ta’ Ambirix li hawn bħalissa ma fihiex thiomersal (kompost organomerkurjali) jew xi preservattiv ieħor.
In a clinical study conducted with 3 doses of the current formulation in adults, the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed with the former thiomersal and preservative containing vaccine formulation.
Fi studju kliniku magħmul bi tliet dożi tal- formulazzjoni ta’ Ambirix li hawn bħalissa, l- inċidenza ta ’ uġigħ, ħmura, nefħa, għeja, gastro- enteite, uġigħ ta ’ ras u deni kienet tixbaħ lill- inċidenza osservata bil- formulazzjoni tal- vaċċin li kien hawn qabel li kien fih thiomersal u preservattiv.
The following adverse reactions have been reported following the widespread use of the former formulation
L- effetti avversi li ġejjin kienu rrappurtati wara l- użu estensiv tal- formulazzjoni li kien hawn qabel.
Clinical trials involved the administration of 2029 doses of Ambirix to 1027 subjects from 1 year up to and including 15 years of age.
Fl- istudji kliniċi ngħataw 2029 doża ta 'Ambirix lil 1027 individwu ta ’ l- etajiet ta ’ bejn sena u 15- il sena, din ta ’ l- aħħar inkluża.
Local and general adverse reactions reported following primary vaccination with Ambirix were categorised by frequency.
Reazzjonijiet avversi lokali u ġenerali li ġew rappurtati wara tilqim primarju b’ Ambirix ġew klassifikati skond il- frekwenza.
Common:
Il- frekwenzi hawn taħt huma rappurtati hekk: ≥ 1/ 10 Komuni ħafna: ≥ 1/ 100 sa < 1/ 10 Komuni: ≥ 1/ 1, 000 sa < 1/ 100 Mhux komuni: ≥ 1/ 10, 000 sa < 1/ 1, 000 Rari:
Rare:
Rarti ħafna:
≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000 < 1/ 10,000
< 1/ 10, 000
Nervous system disorders: very common: headache common: drowsiness
Disturbi fis- sistema nervuża: komuni ħafna: uġigħ ta 'ras komuni: ħedla
Gastrointestinal disorders: common: gastrointestinal symptoms
Disturbi gastro- intestinali: komuni: sintomi gastro- intestinali
Metabolism and nutrition disorders very common: loss of appetite
Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni ħafna: telf t’ aptit
General disorders and administration site conditions very common: pain, redness, fatigue common: swelling, fever
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata komuni ħafna: uġigħ, ħmura, għeja komuni: nefħa, deni
Psychiatric disorders: very common: irritability/ fussiness
Disturbi psikjatriċi: komuni ħafna: irritabilità/ tħanfis
In a study, in 300 subjects aged from 12 years up to and including 15 years, the reactogenicity profile of Ambirix was compared to that of the three-dose combined vaccine.
Fi studju, fuq 300 individwu ta ’ etajiet ta ’ bejn it- 12 u l- 15- il sena, ta ’ l- aħħar inkluża, il- profil tar - reattoġeniċità ta ’ Ambirix ġie imqabbel ma ’ dak tat- tilqima kombinata bi tliet dożi.
The three-dose vaccine contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen in 0.5 ml.
Din it- tilqima bi tliet dożi kien fiha 360 Unitajiet ELISA tal- virus ta ’ l- epatite A inattivat bil- formalina u 10 5 mikrogrammi ta ’ l- antiġen tal- wiċċ ta ’ l- epatite B rekombinanti f’ 0. 5 ml.
The incidence of local and general solicited symptoms after a two dose regimen of Ambirix was overall similar to that seen with the three dose
L- inċidenza ta 'sintomi solleċitati lokali u ġenerali li dehru wara żewġ dożi ta ’ Ambirix kienet ġeneralment tixbaħ lil dik li intweriet bit- tilqima kombinata ta' tliet dożi, fejn l- uniċi eċċezzjonijiet kienu inċidenza akbar ta 'uġigħ u għeja li dehru ma ’ kull doża ta' Ambirix iżda mhux ma ’ kull individwu.
Pain was reported following 50.7% of doses in the Ambirix group, as compared to 39.1% of doses with the three dose combined vaccine.
Ġie rrappurtat uġigħ wara li ngħataw 50. 7% tad- dożi fil- grupp ta ’ dawk li ħadu Ambirix, meta mqabbel ma ’ 39. 1% tad- dożi bit- tilqima kombinata ta 'tliet dożi.
However, over the complete vaccination course, 66.4% of subjects who received Ambirix reported pain, as compared to 63.8% of subjects who received the three dose combined vaccine.
Madankollu, matul il- kors kollu ta ’ tilqim, 66. 4% ta ’ l- individwi li ħadu Ambirix irrappurtaw xi uġigħ, meta mqabbla ma ’ 63. 8% ta ’ l - individwi li ħadu t- tilqima kombinata ta 'tliet dożi.
Fatigue was reported following 29.2% doses of Ambirix, as compared to 19.3% doses of the three dose combined vaccine.
Is- sintomu ta ’ l- għeja ġie rappurtat wara 29. 2% tad- dożi ta ’ Ambirix, meta mqabbla ma '19. 3% tad - dożi bit- tilqima ta ’ tliet dożi.
However, the incidence of fatigue was similar based on a per subject analysis (i. e. over the total vaccination course, 39.6% versus 36.2% of subjects for Ambirix and the three dose vaccine respectively).
Madankollu, l- inċidenza ta ’ l- għeja kienet tixtiebaħ fiż- żewġ gruppi meta saret analiżi fuq kull individwu (jiġifieri matul il- kors kollu tat- tilqim, 39. 6% kontra 36. 2% ta ’ l - individwi li ħadu Ambirix u t- tilqima ta 'tliet dożi rispettivament)
The incidence of pain and fatigue graded as severe was low and similar to that observed with the three dose combined vaccine.
L- inċidenza ta ’ uġigħ u għeja klassifikati bħala serji kienet baxxa u simili għal dik osservata bit - tilqima kombinata bi tliet dożi.
In a comparative trial in subjects aged 1-11 years, the incidences of local and general solicited symptoms in the Ambirix group were similar to those seen with the three-dose combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
Fi studju ta ’ paragun li sar fuq individwi ta ’ etajiet minn sena sa ħdax- il sena, l- inċidenza ta ’ sintomi solleċitati lokali u ġenerali fil- grupp ta ’ Ambirix kienu jixbħu lil dawk li dehru bil- vaċċin kombinat ta ’ tliet dożi li fih 360 Unitajiet ELISA tal- virus epatite A inattivat bil- formalina u 10 mikrogrammi ta ’ l - antiġen tal- wiċċ ta ’ l- epatite B rikombinanti.
The exception was a higher incidence of pain after Ambirix in 6-11 year olds on a per dose basis, but not on a per subject basis.
L- eċċezzjoni kienet li kien hemm inċidenza aktar għolja ta` ugigħ wara li Ambirix ingħatat lil tfal ta ’ etajiet minn sitt snin sa ħdax- il sena li dehru ma kull doża, iżda mhux ma ’ kull individwu.
The percentages of vaccinees reporting any solicited symptom graded as severe during a two-dose regimen of Ambirix or a three dose regimen with the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen, were not statistically different.
Il- persentaġġ ta ’ persuni mlaqqma li rrapurtaw xi sintomu solleċitat li kien klassifikat bħala wieħed serju waqt kors ta ’ żewġ dożi ta ’ Ambirix jew kors ta ’ tliet dożi b’ vaċċin kombinat li fih 360 Unitajiet ELISA tal- virus ta ’ l- epatite A inattivat bil- formalina u 10 mikrogrammi ta ’ l- antiġen tal- wiċċ ta ’ l - epatite B rikombinanti, ma kienux statistikament differenti.
During post-marketing surveillance with the three dose combined vaccine containing either 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen in a dose volume of 0.5 ml (recommended for subjects 1 year up to and including 15 years of age) or 720 ELISA Units of formalin inactivated hepatitis A virus and 20 micrograms of recombinant hepatitis B surface antigen in a dose volume of 1 ml (recommended from the age of 16 years onwards), the following adverse reactions have been reported.
Matul sorveljanza ta ’ wara t- tqegħid fis- suq, tat- tilqima kombinata ta 'tliet dożi, li kien fiha jew 360 Unitajiet ELISA tal- virus ta' l- epatite A mhux attivat bil- formalina u 10 mikrogrammi ta ’ l- antiġen tal - wiċċ ta 'l- epatite B rekombinanti f’ doża ta ’ volum ta ’ 0. 5ml (rakkomandata għal individwi ta ’ bejn sena u 15- il sena, ta' l- aħħar inkluża, jew 720 Unitajiet ELISA tal- virus ta 'l- epatite A inattivat bil - formalina u 20 mikrogramma ta ’ l- antiġen tal- wiċċ ta' l- epatite B rikombinanti b’ doża ta ’ volum ta ’ 1 ml (rakkomandata mill- età ta '16- il sena ’ l fuq), ġew irrappurtati l- effetti avversi li jidhru hawn taħt:
Investigations abnormal liver function tests
Investigazzjonjiet riżultati mhux normali tat- testijiet tal- funzjoni tal- fwied
Blood and lymphatic system disorders thrombocytopenia, thrombocytopenic purpura, lymphadenopathy
Disturbi tad- demm u tas- sistema limfatika tromboċitopenja, purpura tromboċitopenika, limfadenopatija
Nervous system disorders syncope, dizziness, paresthesia, convulsions
Disturbi fis- sistema nervuża sinkope, sturdament, parestesija, konvulżjonijiet
Gastrointestinal disorders: nausea, vomiting, diarrhoea, abdominal pain
Disturbi gastro- intestinali dardir, rimettar, dijarea, uġigħ addominali
Metabolism and nutrition disorders decreased appetite
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda raxx, ħakk, urtikarja
Vascular disorders Hypotension
Disturbi fil- metaboliżmu u n- nutrizzjoni nuqqas t’ aptit
General disorders and administration site conditions flu-like symptoms, fatigue
Disturbi vaskulari pressjoni baxxa 6 Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata sintomi bħal ta ’ l- influwenza, għeja
6 Immune system disorders allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness like disease
Disturbi fis- sistema immuni reazzjonijiet allerġiċi inkluż reazzjonijiet anafilattiċi u anafilaktojd u marda tixbaħ lil serum sickness
Following widespread use of the monovalent hepatitis A and/ or hepatitis B vaccines, the following adverse reactions have additionally been reported.
Wara użu estensiv tat- tilqim monovalenti ta 'l- epatite A u/ jew l- epatite B, dawn l- effetti avversi li ġejjin kienu rappurtati wkoll bħala effetti li ġraw fl- istess żmien meta ingħatat it- tilqima.
Nervous system disorders multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), encephalitis, encephalopathy
Disturbi fis- sistema nervuża sklerozi multipla, mjelite, paraliżi tal- wiċċ, polinevrite bħas- sindrome ta ’ Guillain- Barré (b’ paraliżi li titla ’ l- fuq) enċefalite, enċefalopatija
Eye disorders optic neuritis
Disturbi fl- għajnejn nevrite ottiku
Skin and subcutaneous tissue disorders erythema exsudativum multiforme
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda eritema exsudativum multiforme
Infections and infestations meningitis
Infezzjonijiet u infestazzjonijiet meninġite
Vascular disorders vasculitis
Disturbi vaskulari vaskulite
No case of overdose has been reported.
L- ebda każ ta ’ doża eċċessiva ma ġie rappurtat
Hepatitis vaccines, ATC code J07BC20.
Tilqim ta ’ l- epatite, Kodiċi ATC J07BC20.
Ambirix confers immunity against HAV and HBV infection by inducing specific anti-HAV and anti- HBs antibodies.
Ambirix jagħti immunità kontra l- infezzjoni ta ’ l- HAV u l- HBV billi jinduċi antikorpi speċifiċi anti - HAV u anti- HBs.
In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i. e month 7).
Fi studji kliniċi li involvew individwi mill- età ta ’ sena sa 15- il sena, ta ’ l- aħħar inkluża, ir- rati ta ’ seropositività għall- antikorpi, anti- HAV kienu ta '99. 1%, xahar wara l- ewwel doża u 100% wara t- tieni doża li ngħatat fix- xahar numru 6 (jiġifieri fis- 7 xahar).
Seropositivity rates for anti-HBs antibodies were 74.2% one month after the first dose and 100% after the second dose given at month 6 (i. e. month 7).
Ir- rati ta 'seropositività għall- antikorpi anti - HBs kienu ta ’ 74. 2% xahar wara l- ewwel doża u 100% wara t- tieni doża li ngħatat fix- xahar numru 6 (jiġifieri fis- 7 xahar).
The anti-HBs seroprotection rates (titers ≥ 10 mlU/ ml) at these time points were 37.4% and 98.2% respectively.
F' dan iż- żmien ir- rati ta ’ seroprotezzjoni għall- anti- HBs (titri ≥ 10 mlU/ ml) kienu ta '37. 4% u 98. 2% rispettivament.
In a comparative clinical trial conducted among subjects aged from 12 years up to and including 15 years of age, 142 received two doses of Ambirix and 147 received the standard three-dose combined vaccine.
Sar studju kliniku ta 'paragun fuq individwi ta` etajiet ta ’ bejn it- 12 u l- 15- il sena, ta' l- aħħar inkluża, fejn 142 irċevew żewġ dożi ta’ Ambirix u 147 irċevew it- tilqim standard bi tliet dożi kombinati.
The latter contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
Din ta` l- aħħar kien fiha 360 Unitajiet ELISA tal- virus ta ’ l- epatite A inattivat bil- formalina u 10 mikrogrammi ta ’ l- antiġen tal- wiċċ ta ’ l- epatite B rikombinanti.
For the 289 subjects evaluable for immunogenicity, seroprotection rates (SP in the table below) against hepatitis B were significantly higher at months 2 and 6 with the three-dose vaccine than with Ambirix.
Għall- 289 individwu li ġew evalwati għal immuoġeniċità, ir- rati ta ’ seroprotezzjoni (SP fit- tabella t’ hawn taħt) kontra l- epatite B kienu sostanzjalment ogħla fix- xhur numru 2 u numru 6 meta ngħataw t- tilqima ta 'tlirt dożi ta` vaċċin milli meta ngħataw Ambirix.
Vaccine group
Anti- HBs Anti- HBs
Anti-HBs Month 2 SP (%)
Xahar numru 2
Anti-HBs Month 6 SP (%)
Xahar numru 6
Anti-HBs Month 7 SP (%)
Xahar numru 7
Ambirix
Ambirix Vaċċin kombinat HAB (360/ 10)
38
38 85. 6
98.0
68. 3 98
100
97. 9 100
Immune responses obtained one month after the full vaccination course (i. e at month 7) in a comparative clinical trial in children aged 1-11 years are presented in the following table.
Ir- rispons immuni li ntlaħaq xahar wara l- kors kollu ta ’ tilqim (jiġifieri fix- xahar numru 7) fi prova klinika ta ’ paragun li saret fi tfal ta ’ etajiet ta ’ bejn is- sena u l- ħdax- il sena jidher fit- tabella t’ hawn taħt.
Also shown are the results reported in the comparative study performed in 12-15 year-olds.
Jidhru wkoll ir- riżultati li ġew rappurtati fl- istudju ta ’ paragun fuq tfal ta ’ etajiet ta ’ bejn it- tnax u l- ħmistax- il sena.
In both studies, subjects received either a two dose schedule of Ambirix or a three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
Fiż- żewġ studji, individwi rċevew jew skeda ta ’ żewġ dożi ta ’ Ambirix jew kors ta ’ tliet dożi tal- vaċċin kombinat li kien fih 360 Unitajiet ELISA tal- virus ta ’ l- epatite A inattivat bil - formalina u 10 mikrogrammi ta ’ l- antiġen tal- wiċċ ta ’ l- epatite B rikombinanti.
Age group
Grupp ta ’ etajiet
Vaccine group
Grupp tal- vaċċin
1-5 yrs old
Etajiet minn 1- 5 snin
Combined HAB vaccine (360/ 10)
Vaċċin kombinat HAB (360/ 10)
6-11 yrs old
Etajiet minn 6- 11 il - sena
12-15 yrs old
Etajiet minn 12- 15 il - sena
In a clinical study, 102 subjects aged from 12 years up to and including 15 years received the second dose of Ambirix at month 12, seropositivity rates for anti-HAV were 99.0% and seropositivity rates for anti-HBs were 99.0% at month 13 with seroprotection rates of 97.0%.
Fi studju kliniku li sar fuq 102 individwi ta`etajiet ta ’ bejn it- 12 u l- 15- il sena, ta 'l- aħħar inkluża, li ngħataw it- tieni doża ta' Ambirix fix- xahar numru 12, ir- rati ta 'seroposittività għall- anti- HAV kienu ta' 99. 0% u r- rati ta 'seropositività għall- anti- HBs kienu ta' 99. 0% fix- xahar numru 13 b' rati ta 'seroprotezzjoni ta' 97. 0%.
In subjects aged 12-15 years at the time of primary vaccination, anti-HAV and anti-HBs antibodies have been shown to persist for at least 24 months following the initiation of a 0, 6 month schedule of Ambirix.
F`individwi li kellhom etajiet ta ’ bejn it- 12- 15- il sena fiż- żmien meta ħadu t- tilqim primarju, l - antikorpi, anti- HAV u anti- HBs baqgħu jidhru għal mill- anqas 24 xahar wara l- bidu ta ’ skeda ta '0, 6 xahar fit- teħid ta’ Ambirix.
Seropositivity rates were 100% and 94.2% respectively for anti-HAV and anti-HBs antibodies at month 24.
Ir- rati ta 'seropositività kienu 100% u 94. 2% rispettivament għal antikorpi anti- HAV u anti HBs fix- xahar numru 24.
The seroprotection rate for anti-HBs at this time point was 93.3%.
Ir- rata ta 'seroprotezzjoni għall- anti- HBs f’ dan iż- żmien kienet 93. 3%.
In this study, the immune response to both antigen components was comparable to that seen after a 3-dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10µg of recombinant hepatitis B surface antigen in a dose volume of 0.5 ml.
F' dan l- istudju, ir- rispons immuni għaż- żewġ antiġeni kienet tipparaguna tajjeb ma ’ dik li dehret wara l- kors ta 'tliet dożi tat- tilqima kombinata li kien fiha 360 Unitajiet ELISA tal- virus ta' l - epatite A inattivat bil- formalina u 10 µg ta ’ l- antiġen tal- wiċċ ta 'l- epatite B rikombinanti f' doża b' volum ta ’ 0. 5 ml.
In a clinical study involving subjects from 12 years up to and including 15 years of age, the persistence of anti-HAV and anti-HBs antibodies at month 24 was shown to be similar following a 0, 6 month or a 0, 12 month schedule.
Fi studju kliniku li kien jinvolvi individwi ta 'bejn it- 12 u l- 15- il sena, ta' l- aħħar inkluża, il- persistenza ta ’ l- antikorpi, anti- HAV u anti- HBs fix- xahar numru 24 irriżulta li kienet tixbaħ lil dik wara skeda ta ’ 0, 6 xhur jew skeda ta ’ 0, 12- il xahar.
When the first dose of Ambirix was administered concomitantly with a booster dose of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV/ Hib) or with the first dose of a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory.
Meta ngħatat l- ewwel doża ta’ Ambirix flimkien ma doża ta ’ rinforz ta` vaċċin kombinat tad- difterite, tetnu, pertussis aċellulari, poljomelite inattivat u Haemophilus influenzae tat- tip b (DTPa- IPV/ Hib) jew ma ’ l- ewwel doża ta` vaċċin kombinat kontra il- Ħożba, il- Ġidri u r- Rubella fit- tieni sena mit - twelid, ir- rispons immuni għall- antiġeni kollha kien kif mixtieq.
These data were generated with the former Ambirix formulation containing thiomersal and a preservative.
Dan it- tagħrif ħareġ bil- formulazzjoni ta’ qabel ta’ Ambirix li kien fiha thiomersal u preservattiv.
A clinical study conducted with 3 doses of the current formulation in adults showed that the current formulation elicited similar seroprotection and seroconversion rates as compared to the former formulation.
Studju kliniku fl- adulti li sar bit- 3 dożi tal- formulazzjoni li hawn bħal issa, wera li l- formulazzjoni li hawn bħalissa siltet rati ta ’ seroprotezzjoni u serokonverżjoni jixtiebħu meta mqabbla mal- formulazzjoni ta ’ qabel.
Evaluation of pharmacokinetic properties is not required for vaccines.
8 Valutazzjoni tal- kwalitajiet farmakokinetiċi mhix meħtieġa għal vaċċini.
5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurta' tal- mediċina
Non-clinical data reveal no special hazard for humans based on general safety studies.
Tagħrif mhux kliniku bbażat fuq studji ġenerali dwar sigurtà ma juri l- ebda periklu speċjali għall - bnedmin..
Store in the original package, in order to protect from light.
Aħżen fil- pakkett oriġinali, sabiex tilqa ’ mid- dawl.
1 ml of suspension in a prefilled syringe (type I glass) with a plunger stopper (rubber butyl).
1 ml ta ’ suspensjoni f' siringa mimlija għal- lest (ħġieġ tat- tip I) magħluqa bi planġer (lastku butyl).
Pack sizes of 1 and 10 with or without needles and pack size of 50 without needles.
Pakketti b’ 1 u b’ 10 bil- labar jew mingħajr labar u pakkett b’ 50 mingħajr labar.
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Meta jinħażen, jista ’ jiġi osservat depożitu abjad fin b’ saff likwidu ċar bla kulur fil- wiċċ.
Before administration, the vaccine should be well shaken to obtain a slightly opaque, white suspension.
Qabel jingħata, il- vaċċin għandu jitħawwad sewwa biex tinkiseb suspensjoni bajda u ftit opaka.
The vaccine should be visually inspected both before and after resuspension for any foreign particulate matter and/ or change in physical appearance.
Il- vaċċin għandu jiġi mifli viżwalment kemm qabel kif ukoll wara r- risuspensjoni għal xi frak u/ jew bidla fid- dehra fiżika.
The vaccine must not be used if any change in the appearance of the vaccine has taken place.
Il- vaċċin m’ għandux jintuża jekk ikun hemm xi bidla fid- dehra tal- vaċċin.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- vaċċin li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
GlaxoSmithKline Biologicals s. a. rue de l'Institut 89 B-1330 Rixensart, Belgium
9 GlaxoSmithKline Biologicals s. a rue de l' institut 89 B- 1330 Rixensart, Il- Belġju
MARKETING AUTHORISATION NUMBER(S)
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L - AWTORIZZAZZJONI
30 August 2002 Date of latest renewal:
30 t’ Awwissu 2002 Data ta ’ l- aħħar tiġdid:
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Name and address of the manufacturer of the biological active substances
Isem u indirizz tal- manifattur tas- sustanzi bijoloġiċi attivi
Rue de l’ Institut 89 1330 Rixensart Belgium
Rue de l’ Institut 89 1330 Rixensart Il- Belġju
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU EFFETTIV TAL- PRODOTT MEDIĊINALI
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 jsir 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 se jkompli jissottometti PSURs ta ’ kull sena.
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 10 PRE-FILLED SYRINGES WITH NEEDLES 50 PRE-FILLED SYRINGES WITHOUT NEEDLES
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA SIRINGA WAHDA MIMLIJA GĦAL- LEST MINGĦAJR LABRA SIRINGA WAĦDA MIMLIJA GHAL- LEST BIL- LABRA 10 SIRINGI MIMLIJA GĦAL- LEST MINGĦAJR LABAR 10 SIRINGI MILIJA GHAL- LEST BIL- LABAR 50 SIRINGA MIMLIJA GHAL- LEST MINGĦAJR LABAR
Ambirix– Suspension for injection Hepatitis A (inactivated) and hepatitis B(rDNA) (HAB) vaccine (adsorbed).
Ambirix – Suspensjoni għall- injezzjoni Vaċċin (adsorbit) ta ’ l- epatite A (inattivat) u epatite B( r DNA) (HAB).
1 dose (1 ml):
Doża waħda (1 ml):
Hepatitis A virus (inactivated)1,2 Hepatitis B surface antigen 3,4 1 Produced on human diploid (MRC-5) cells 2
Virus ta ’ l- epatite A (inattivat) 1, 2 Antiġen tal- wiċċ ta ’ l- epatite B3, 4 1 Magħmul fuq ċelluli diplojdi (MRC- 5) umani 2 Adsorbit fuq aluminium hydroxide, idratat 3
720 ELISA Units 20 micrograms
720 Unitajiet ELISA 20 mikrogramma 0. 05 milligramma Al3+
Adsorbed on aluminium hydroxide, hydrated
LISTA TA 'SUSTANZI MHUX ATTIVI
0.05 milligrams Al3+
Sodium chloride Ilma għall- injezzjonijiet
Suspension for injection 1 pre-filled syringe without needle 1 pre-filled syringe with needle 10 pre-filled syringes without needles 10 pre-filled syringes with needles 50 pre-filled syringes without needles 1 dose (1 ml)
Suspensjoni għall- injezzjoni Siringa waħda mimlija għal- lest mingħajr labra Siringa waħda mimlija għal- lest bil- labra 10 siringi mimlija għal- lest mingħajr labar 10 siringi mimlija għal- lest bil- labar 50 siringa mimlija għal- lest mingħajr labar Doża waħda (1ml)
Intramuscular use Shake before use
Użu għal ġol- muskoli Ħawwad 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 il- prodott fil- pakkett oriġinali sabiex tilqa ’ mid- dawl
Dispose of in accordance with local regulations.
Armi skond il- liġijiet lokali
EU/ 1/ 02/ 224/ 001 1 pre-filled syringe without needle EU/ 1/ 02/ 224/ 002 1 pre-filled syringe with needle EU/ 1/ 02/ 224/ 003 10 pre-filled syringes without needles EU/ 1/ 02/ 224/ 004 10 pre-filled syringes with needles EU/ 1/ 02/ 224/ 005 50 pre-filled syringes without needles
EU/ 1/ 02/ 224/ 001 Siringa waħda mimlija għal- lest mingħajr labra EU/ 1/ 02/ 224/ 002 Siringa waħda mimlija għal- lest bil- labra EU/ 1/ 02/ 224/ 003 10 siringi mimlija għal- lest mingħajr labar EU/ 1/ 02/ 224/ 004 10 siringi mimlija għal- lest bil- labar EU/ 1/ 02/ 224/ 005 50 siringa mimlija għal- lest mingħajr labar
Medicinal product subject to medical prescription
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
INSTRUCTIONS ON USE
Prodott mediċinali li jingħata bir- riċetta tat- tabib
16 Justification for not including Braille accepted
INFORMAZZJONI BIL- BRAILLE 16 Il- Ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA MIMLIJA GĦAL- LEST
Ambirix, suspension for injection HAB vaccine IM
Ambirix, suspensjoni għall- injezzjoni Vaċċin HAB IM
1 dose (1 ml)
Doża 1 (1 ml)
INFORMATION FOR THE USER
19 FULJETT TA ’ TAGĦRIF: iNFORMAZZJONI GħAL MIN QED JAGħMEL UżU MINNHA
Ambirixsuspension for injection Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Ambirix suspensjoni għall- injezzjoni Vaċċin (adsorbit) ta ’ l- epatite A (inattivat) u l- epatite B (rDNA) (HBV)
Read all of this leaflet carefully before you start/ your child starts receiving this vaccine.
Aqra sew dan il- fuljett kollu qabel ma inti/ ibnek/ bintek tibdew tieħdu dan il- vaċċin.
- This vaccine has been prescribed for you/ your child.
- Din it- tilqima ġiet mogħtija lilek/ lill- ibnek/ lill- bintek.
What Ambirix is and what it is used for 2.
X’ inhu Ambirix u għalxiex jintuża 2.
Before you receive/ your child receives Ambirix 3.
Qabel inti/ ibnek/ bintek tieħdu Ambirix 3.
How Ambirix is given 4.
Kif għandu jingħata Ambirix 4.
How to store Ambirix 6.
Kif taħżen Ambirix 6.
WHAT AMBIRIX IS AND WHAT IT IS USED FOR
X’ INHU AMBIRIX U GĦALXIEX JINTUŻA
Ambirix is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two infectious diseases: hepatitis A and hepatitis B.
Ambirix huwa vaċċin li jintuża fit- trabi, tfal u adolexxenti mill- eta ’ ta ’ sena sa 15- il sena, ta 'l- aħħar inkluża, biex jipproteġihom minn żewġ mardiet infettivi: l- epatite A u l- epatite B.
The vaccine works by causing the body to produce its own protection (antibodies) against these infectious diseases.
Il- vaċċin jaħdem billi jġiegħel lill- ġisem jipproduċi protezzjoni għalih innifsu (antikorpi) kontra dan il- mard infettiv.
• Hepatitis A:
• L- epatite A:
Hepatitis A is an infectious disease that affects the liver, caused by the hepatitis A virus.
L- epatite A hija marda infettiva li taffettwa l- fwied, ikkawżata mill- virus ta ’ l- epatite A.
The hepatitis A virus is usually caught from food or drink that contains the virus, but is sometimes spread by other means, such as swimming in water contaminated by sewage.
Il- virus, ta ’ l- epatite A normalment jittieħed mill- ikel jew mix- xorb li jkun fihom il- virus, iżda kultant jinxtered b’ modi oħra wkoll, per eżempju b’ għawm f’ ilma kontaminat bid- drenaġġ.
Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus.
Sintomi ta ’ l- epatite A jibdew minn 3 sa 6 ġimgħat wara li tiġi f’ kuntatt mal- virus.
These consist of nausea (feeling sick), fever and aches and pains.
Dawn jinkludu dardir (tħossok ser tirremetti), deni u wġigħ.
After a few days the whites of eyes and skin may become yellowish (jaundice).
Wara xi ftit ġranet l- abjad ta ’ l- għajnejn u l- ġilda għandhom mnejn isiru safranin (suffejra).
The severity and type of symptoms can vary.
Il- qawwa u t- tip ta ’ sintomi jistgħu jvarjaw.
Young children may not develop jaundice.
Tfal żgħar għandhom mnejn ma taqbadhomx is- suffejra.
Most people recover completely but the illness is usually severe enough to keep people ill for about a month.
Il- biċċa l- kbira tan- nies ifiequ kompletament iżda normalment il- marda hi kiefra biżżejjed li żżomm in- nies morda għal madwar xahar.
• Hepatitis B:
• L- epatite B:
Infection with the hepatitis B virus may cause the liver to become swollen (inflamed).
Infezzjoni bil- virus ta 'l- epatite B tista ’ ġġiegħel il- fwied jintefaħ (jifjamma).
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Il- virus jinstab f' likwidi tal- ġisem bħad- demm, semen, tnixxijiet tal- vaġina, jew bżieq ta 'nies infettati.
Symptoms may not be seen for 6 weeks to 6 months after infection.
Is - sintomi jistgħu jdumu ma jidhru minn 6 ġimgħat sa 6 xhur wara l- infezzjoni.
Sometimes people who have been infected do not look or feel ill.
Kultant nies infettati la jkunu jidhru u lanqas iħossuhom mhux f' sikithom.
Others have mild flu-like symptoms, but some people can become very ill.
Oħrajn ikollhom sintomi ħfief jixbħu l - influwenza, biss xi wħud jistgħu jimirdu sew.
They may be extremely tired, and have dark urine, pale faces, yellowish skin and/ or eyes (jaundice), and other symptoms possibly requiring hospitalisation.
Huma jistgħu jkunu għajjenin ħafna, u jkollhom l - awrina skura, wiċċhom pallidu, il- ġilda u/ jew l- abjad t’ għajnejhom safranin (suffejra), u sintomi oħra li minħabba fihom jista ’ jkollhom bżonn jittieħdu l- isptar.
Most adults fully recover from the disease.
Il- biċċa l- kbira ta ’ l- adulti jfiequ kompletament minn din il- marda.
But some people, particularly children, who may not have had symptoms can remain infected.
Biss xi wħud, speċjalment tfal, li seta ’ ma kellhom ebda sintomi jistgħu jibqgħu infettati.
They are called hepatitis B virus carriers.
Dawn jissejħu ġarriera tal- virus, ta ’ l - epatite B.
Hepatitis B carriers can infect others throughout their lives.
Dawk li jġorru l- epatite B jistgħu jinfettaw oħrajn tul ħajjithom kollha.
Hepatitis B carriers are at risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer.
Dawk li jġorru l - epatite B huma fil- periklu ta 'mard serju tal- fwied, bħaċ- ċirrożi (merk fil- fwied) u kanċer tal- fwied.
The vaccine does not contain live virus and cannot cause hepatitis A or B infections.
Il- vaċċin ma fihx il- virus ħaj u ma jistax jikkawża infezzjonijiet ta ’ l- epatite A jew B.
As with all vaccines, Ambirix cannot completely prevent infections with hepatitis A or B viruses, even after you have/ your child has received both doses.
Bħall b’ kull vaċċin ieħor, Ambirix ma jistax jipproteġik għal kollox kontra l- virus ta ’ l- epatite A jew B, anke wara li inti / ibnek/ bintek tkunu ħadtu ż- żewġ dożi.
20 Also, if you have/ your child has already been infected with hepatitis A or B virus (although not yet feeling unwell) before having both doses of Ambirix, the vaccine may not be able to prevent you/ your child becoming ill.
20 Saħansitra jekk inti/ ibnek/ bintek kontu diġà infettati bil- virus ta ’ l- epatite A jew B (għalkemm xorta għadkom tħossukom f' sikkitkom) qabel tieħdu ż- żewg dożi ta` Ambirix, il- vaċċin jista ’ ma jipproteġix lilek/ lill- ibnek/ lill- bintek milli timirdu..
Ambirix can only help to protect you/ your child against infections with hepatitis A or B viruses.
Ambirix jista ’ biss jgħin biex jipproteġi lilek/ lill- ibnek/ lill- bintek kontra l- virus ta ’ l- epatite A jew B.
It cannot protect you/ your child against other infections that can affect the liver that can cause symptoms similar to those of hepatitis A or B infections.
Ma jistax jipproteġi lilek/ lill- ibnek/ lill- bintek kontra infezzjonijiet oħra li jistgħu jaffettwaw il- fwied u li jistgħu jikkaġunaw sintomi li jixbħu lil dawk ta ’ l- infezzjonijet ta ’ l- epatite A jew B.
BEFORE YOU RECEIVE/ YOUR CHILD RECEIVES AMBIRIX
QABEL MA INTI / IBNEK/ BINTEK TIBDEW TIEĦDU AMBIRIX
Ambirix should not be given:
Ambirix m' għandux jingħata:
• if you have/ your child has previously had any allergic reaction to Ambirix, or any ingredient contained in this vaccine including neomycin (antibiotic).
• jekk inti/ ibnek/ bintek fil- passat kellkom xi reazzjoni allerġika għal Ambirix, jew għal xi sustanza li hemm f' dan il- vaċċin inkluż neomycin (anti- bijotiku).
The active substances and other ingredients in Ambirix are listed at the end of the leaflet.
Is- sustanzi attivi u sustanzi oħra ta’ Ambirix 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 you have/ your child has previously had an allergic reaction to any vaccine against hepatitis A or hepatitis B diseases. • if you have/ your child has a severe infection with a high temperature.
Sinjali ta 'reazzjoni allerġika jistgħu jinkludu raxx tal- ġilda li jieklok, qtugħ ta' nifs u nefħa fil- wiċċ jew fl- ilsien. • jekk inti/ ibnek/ bintek fil- passat kellkom xi reazzjoni allerġika għal xi vaċċin kontra l- mard ta 'l - epatite A jew l- epatite B. • jekk inti/ ibnek/ bintekgħandkom xi infezzjoni qawwija b’ deni għoli.
In these cases, the vaccination will be postponed until you/ your child has recovered.
F’ dawn il- każijiet, it- tilqima m’ għandhiex tingħata qabel ma ’ inti/ ibnek/ bintek tfiequ.
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Infezzjoni żgħira bħal riħ m’ għandhiex tkun problema, biss dejjem kellem lit- tabib tiegħek l- ewwel.
Take special care with Ambirix:
Oqgħod attent ħafna b’ Ambirix:
• if you think that you need to be protected rapidly against hepatitis B infection, that is, within six months and before the second dose will be due.
• jekk taħseb li għandek tiġi protett/ a malajr kontra l- infezzjoni ta ’ l- epatite B, jiġifieri fi żmien sitt xhur u qabel ma jkun imissek tieħu t- tieni doża.
If you are/ your child is likely to be at risk of hepatitis B infection between the timing of the first and second injections, your doctor will probably recommend that you do/ your child does not receive Ambirix.
Jekk inti/ ibnek/ bintek aktarx li qegħdin f' riskju ta ’ l- epatite B bejn iż- żmien ta ’ l- ewwel u t- tieni injezzjoni, it- tabib tiegħek aktarx jirrakkomanda li int/ ibnek/ bintek m’ għandkomx tieħdu Ambirix.
Instead, you/ your child will probably need to have three injections of a combined hepatitis A and hepatitis B vaccine that has a lower content in each dose of the active substances (360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen).
Minflok inti/ ibnek/ bintek, aktarx ikollkom bżonn ta ’ tliet injezzjonijiet tat- tilqima kombinata ta ’ l- epatite A u l- epatite B li f' kull doża jkun fiha kontenut inqas tas- sustanzi attivi (360 Unitajiet ELISA tal- virus ta 'l- epatite A mhux attivat bil- formalina u 10 mikrogrammi ta ’ l- antiġen tal- wiċċ ta' l- epatite B rekombinanti).
The second of the three doses of this lower dose vaccine is usually given at one month after the first dose, and it is more likely to protect you/ your child against hepatitis B before the course is completed.
It- tieni mit- tliet dożi ta ’ din it- tilqima b’ doża mnaqqsa normalment tingħata xahar wara l- ewwel doża, u aktarx li tipproteġi lilek/ lill- ibnek/ lill- bintek aktar kontra l- epatite B qabel ma jintemm il- kors kollu.
Your doctor will be able to advise you. • if you have/ your child has a bleeding problem or bruise/ bruises easily.
It- tabib ikun jista ’ jgħatik parir. • jekk inti/ ibnek/ bintekgħandkom xi problema tal- fsada jew jekk titbenġlu malajr.
Sometimes Ambirix is given as an injection just under the skin instead of into muscle in people who have severe bleeding problems. • if you have/ your child has a poor immune system due to illness or treatment or if you are/ your child is receiving haemodialysis.
Xi drabi, Ambirix jingħata bħala injezzjoni eżatt taħt il- ġilda minflok fil- muskolu f`persuni li jbatu minn problemi serji ta ’ fsada.. • jekk int/ ibnek/ bintek għandkom is- sistema immuni batuta minħabba xi mard jew xi mediċini jew jekk int/ ibnek/ bintek qegħdin fuq xi dijaliżi tad- demm.
Ambirix can still be given but these people may not have a good response to the vaccine and it may be necessary to do a blood test to see how well they have responded.
Ambirix jista ’ jingħata xorta waħda iżda dawn il- persuni jista ’ ma jkollhomx rispons tajjeb għall- vaċċin u jista ’ jkun hemm il- bżonn li jittieħed test tad- demm sabiex jiġi stabbilit ir- rispons.
Tell your doctor if you are taking any medicines (including any that you may have obtained without a prescription) or if you have recently had or expect to shortly have any other vaccinations or injections of immunoglobulins (antibodies).
Għid lit- tabib tiegħek jekk inti qed tieħu xi mediċini (inkluż mediċini li ksibt mingħajr riċetta) jew jekk dan l- aħħar ħadt jew dalwaqt se tieħu kwalunkwe tilqim ieħor jew injezzjonijiet ta ’ immunoglobulini (antikorpi).
Ask your doctor if you are not sure.
Staqsi lit- tabib tiegħek jekk m’ intix fiż- żgur
People who are taking medicines that decrease the body’ s immunity to infections can still have Ambirix if this is thought to be necessary but may not have a good immune response to the vaccine and so may not be protected against one or both of hepatitis A and B viruses.
Persuni li qegħdin jieħdu mediċini li jnaqqsu ir- rispons immunoloġiku tal- ġisem għall- infezzjonijiet xorta jistgħu jieħdu Ambirix jekk dan hu maħsub li hu neċessarju iżda jista ’ ma jkunx hemm rispons immuni xieraq għall- vaċċin u għalhekk dawn il- persuni jistgħu ma jkunux protetti kontra waħda jew iż- żewġ viruses ta ’ l- epatitie A u B.
Ambirix can be given at the same
Ambirix jista ’ jingħata fl- istess żmien mal- vaċċin li fih il- viruses tal- ħożba, tal- ġidri u tar- rubella u ma ’ vaċċini li huma maħsuba sabiex jipproteġuk minn wieħed jew aktar mill- viruses tad- difterite, tetnu, pertussis (sola konvulsiva), poljomelite jew Haemophilus influenzae tat- tip b.
21 time as other vaccines if this is thought to be very necessary.
Ambirix jista ’ 21 jingħata fl- istess żmien ma ’ vaċċini oħra jekk huwa maħsub li huwa verament neċessarju.
If another vaccine is to be given at the same time as Ambirix, separate sites and preferably different limbs should be used.
Jekk għandu jingħata vaċċin ieħor fl- istess ħin ta ’ Ambirix zoni separati u preferibbilment dirgħajn differenti għandhom jintużaw.
If Ambirix has to be given at the same time as or shortly before or after an injection of immunoglobulins, it is likely that you will still make a good immune response to the vaccine.
Jekk Ambirix irid jingħata fl- istess ħin jew ftit qabel jew ftit wara injezzjoni ta ’ immunoglobulini, r - rispons immunoloġiku għall- vaċċin wisq probabbli xorta jkun tajjeb.
Tell your doctor if you are or think you may be pregnant or if you are breast-feeding.
Għid lit- tabib tiegħek jekk int tqila jew jekk taħseb li tista ’ tkun tqila jew jekk qiegħda tredda ’.
Ambirix is not usually given to women who are pregnant or breast-feeding unless it is urgent for them to be vaccinated against both hepatitis A and B.
Ambirix normalment ma jingħatax lin- nisa tqal jew li qed ireddgħu sakemm ma jkunx hemm xi urġenza u jkollhom jitlaqqmu malajr kontra l- epatite A u B.
Drowsiness and dizziness have sometimes occurred after having Ambirix or a similar vaccine.
Wara t- teħid ta’ Ambirix jew tilqim ieħor simili ġieli kien hemm każijiet ta ’ ħedla u sturdament.
Important information about some of the ingredients of Ambirix Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ambirix Jekk jogħġbok għid lit- tabib tiegħek jekk kellek xi reazzjoni allerġika għal- neomycin (anti- bijotiku).
HOW AMBIRIX IS GIVEN
KIF JINGĦATA AMBIRIX
You/ your child will receive a total of two injections.
Int/ ibnek/ bintek b’ kollox tingħataw żewġ injezzjonijiet.
These will be given within 12 months.
Dawn jingħataw fi żmien tnax- il xahar.
Each injection is given on a separate visit.
Kull injezzjoni tingħata fi żjara separat.
The first dose will be given on a date agreed with your doctor.
L- ewwel doża tingħata f' ġurnata miftiehma mat- tabib tiegħek.
The second dose will be given between six and twelve months after the first dose.
It- tieni doża tingħata minn sitt xhur sa tnax- il xahar wara l- ewwel doża.
It is not known exactly how long protection against infection with hepatits A and B viruses will last, although protection against hepatitis A virus probably lasts about 10 years.
M’ huwiex magħruf bl- eżatt kemm iddum il- protezzjoni kontra l- virus ta ’ l- infezzjoni ta ’ l- epatite A u B, għalkemm il- protezzjoni kontra l- virus ta ’ l- epatite A aktarx tibqa ’ għal għaxar snin.
Patients with poor immune systems may need more frequent additional doses.
Pazjenti b' sistema immuni batuta jista ’ jkollhom bżonn ta ’ aktar dożi, frekwenti.
Your doctor will advise on the possible need for extra doses.
It- tabib jgħidlek dwar jekk hemmx il- ħtieġa ta ’ dożi oħra.
If you miss/ your child misses the visit scheduled for the second injection, talk to your doctor and arrange another visit as soon as possible.
Jekk int/ ibnek/ bintek titilfu l- vista skedata għat- tieni injezzjoni, kellem lit- tabib u għamel arranġament għal vista oħra kemm jista ’ jkun malajr.
Make sure you finish/ your child finishes the complete vaccination course of two injections.
Kun żgur li int/ ibnek/ bintek tkunu temmejtu l- kors sħiħ ta 'tilqim ta' żewġ injezzjonijiet.
If not, you/ your child may not be fully protected against the diseases.
Jekk le, int/ ibnek/ bintek tistgħu ma tkunux protetti kompletament kontra dan il- mard.
The doctor or nurse will give Ambirix as an injection into muscle, usually into the upper arm.
It- tabib jew l- infermier jagħtu Ambirix bħala injezzjoni fil- muskolu, normalment fin- naħa ta ’ fuq tad - driegħ.
In very small children, the injection may be given into the thigh muscle.
Fi tfal żgħar ħafna, l- injezzjoni tista ’ tingħata fil- muskolu tal- koxxa.
Your doctor or nurse will take care that Ambirix is not given into a vein.
It- tabib jew l- infermier tiegħek joqgħodu attenti li Ambirix ma jingħatax f' xi vina.
The vaccine would not usually be given deep into the skin because protection may be less.
Normalment it- tilqima ma tingħatax fil- ġilda fil- fond minħabba li b’ hekk il- protezzjoni tista ’ tkun inqas.
This is usually done when there is a risk of severe bleeding after an injection into muscle.
Dan normalment isir meta jkun hemm riskju ta ’ fsada serja wara injezzjoni fil- muskolu.
Like all medicines, Ambirix can cause side effects, although not everybody gets them.
Bħal kull mediċina, Ambirix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects that occurred during clinical trials with Ambirix were as follows:
Effetti sekondarji li dehru waqt studji kliniċi b’ Ambirix kienu kif ġej:
♦ Very common (more than 1 in 10 doses of vaccine): • Pain or discomfort at the injection site or redness • Tiredness • Irritability • Headache
♦ Komuni ħafna (aktar minn każ wieħed minn kull 10 dożi ta ’ vaċċin): • Uġigħ jew skomfort fis- sit ta ’ l- injezzjoni jew ħmura • Għeja • Irritabbilità • Uġigħ ta 'ras 22
Loss of appetite
Nuqqas t’ aptit
♦ Common (up to 1 in 10 doses of vaccine): • Swelling at the injection site • Fever (more than 38°C) • Drowsiness • Stomach and digestive complaints
♦ Komuni (sa każ 1minn kull 10 dożi ta ’ vaċċin): • Nefħa fis- sit ta 'l- injezzjoni • Deni (aktar minn 38°C) • Ħedla • Disturbi fl- istonku u fis- sistema diġestiva
Additional side effects that have been reported very rarely (less than 1 in 10,000 doses of vaccine) in the days or weeks after vaccination with very similar combined or individual hepatitis A and hepatitis B vaccines, include:
Xi effetti sekondarji oħra li ġew irrapurtati f’ każijiet rari ħafna (inqas minn doża 1 minn kull 10, 000 doża ta ’ vaċċin) fil- ġranet jew il- ġimgħat ta ’ wara tilqim b’ vaċċini li jixbħu ħafna lill- vaċċini ta ’ l - epatite A u l- epatite B kombinati jew separati jinkludu:
Allergic reactions.
Reazzjonijet allerġiċi.