qanastek/EMEA-V3 huggingface dataset:
For some categories of subjects or patients exposed to HBV (e. g; haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥ 10IU/ l.
Emodijaliżi jew pazjenti immunokompromessi) għandha tittieħed attitudni ta ’ prekawzjoni sabiex tiżgura livell ta ’ antikorpi ≥10 IU/ 1.
It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Għadu ma ġiex stabbilit jekk individwi immunokompetenti li rrispondew għal tilqima bil- Epatite A jinħtieġux doża ta ’ rinforz billi fl- assenza ta ’ antikorpi evidenti jista jkun li l- protezzjoni tiġi assigurata bil - memorja immunoloġika.
Guidelines for boosting are based on the assumption that antibodies are required for protection; anti-HAV antibodies have been predicted to persist for at least 10 years.
Huwa maħsub li l- antikorpi anti- HAV jippersistu minn ta ’ l- anqas 10 snin.
In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Adult can be given.
F’ sitwazzjonijiet fejn doża ta ’ rinforz kemm tal- epatite A u l- epatite B huwa meħtieġ, Twinrix Adult jista jingħata.
Alternatively, subjects primed with Twinrix Adult may be administered a booster dose of either of the monovalent vaccines.
Jew inkella, suġġetti mibdija bi Twinrix Adult jistgħu jingħataw doża ta ’ rinforz b ’ waħda mill - vaċċini individwali.
Twinrix Adult is for intramuscular injection, preferably in the deltoid region.
Twinrix Adult jingħata b ’ injezzjoni fil- muskolu, l- aħjar fil- muskolu deltoid.
Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
F’ każijiet rari, il- vaċċin għandu jingħata taħt il- ġilda f’ pazjenti b’ nuqqas ta ’ pjastrini jew fejn id- demm ma jkunx jagħqad sew.
However, this route of administration may result in suboptimal immune response to the vaccine.
Madanakollu, b’ dan il- mod, ir- rispons ta ’ l- immunita ’ jista ma jkunx tal- livell mixtieq.
Hypersensitivity to the active substances or to any of the excipients or neomycin.
Ipersensittivita ’ għas- sustanzi attivi jew għal xi wieħed mis- sustanzi mhux attivi jew neomycin.
Hypersensitivity after previous administration of hepatitis A and/ or hepatitis B vaccines.
Ipersensittivita ’ wara tilqim li jkun ingħata qabel għal- epatite A u/ jew epatite B.
The administration of Twinrix Adult should be postponed in subjects suffering from acute severe febrile illness.
L- użu tat- Twinrix Adult għandu jiġi pospost f’ suġġetti li għandhom mard li jagħti deni akut u serju ħafna.
It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
Jista jkun li fil- ħin tat- tilqima is- suġġett ikun fil- perjodu ta ’ inkubazzjoni tal- marda epatite A jew B.
It is not known whether Twinrix Adult will prevent hepatitis A and hepatitis B in such cases.
Mhuwiex magħruf jekk Twinrix Adult iwaqqafx l- epatite A u B f’ dawn il- każijiet.
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Il- vaċċin ma jwaqqafx infezzjonijiet li huma kawżati b’ aġenti oħra bħall- epatite C u l- epatite E kif ukoll patoġeni magħrufa li jinfettaw il- fwied.
3 Twinrix Adult is not recommended for postexposure prophylaxis (e. g. needle stick injury).
Twinrix Adult mhux irrakkomandat għal prevenzjoni ta ’ wara l- esposizzjoni għall- virus (eż. tniggist b’ labbra użata).
The vaccine has not been tested in patients with impaired immunity.
3 Il- vaċċin ma ġiex ippruvat fuq pazjenti b’ immunita ’ baxxa.
In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.
F’ pazjenti fuq l- emodijaliżi jew pazjenti b ’ immunita ’ baxxa, livelli adekwati tal- antikorpi anti- HAV u anti- HBs jistgħu ma jintlaħqux wara l- ewwel kors primarju ta ’ tilqim u dawn il- pazjenti jista jkollhom bżonn li jingħatalhom dożi addizzjonali oħra ta ’ vaċċin.
Obesity (defined as BMI ≥ 30 kg/ m2) has been observed to reduce the immune response to hepatitis A vaccines.
Ġie osservat li l- obeżità (definita bħala BMI ≥ 30 kg/ m2) tnaqqas ir- rispons ta ’ l- immunità għall- vaċċini ta ’ l- epatite A.
A number of factors have been observed to reduce the immune response to hepatitis B vaccines.
Hemm xi fatturi li jnaqqsu r- rispons ta ’ l- immunita ’ għall- vaċċini ta ’ l- epatite B.
These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases.
Dawn jinkludu eta ’ avvanzata, sess maskili, ħxuna, tipjip, rotta ta ’ kif jingħata, u xi mard kroniku.
Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Twinrix Adult.
Wieħed għandu jikkonsidra jagħmel xi eżamijiet seroloġiċi f ’ dawk li għandhom riskju li ma jilħqux seroprotezzjoni wara kors sħiħ ta ’ Twinrix Adult.
Additional doses may need to be considered for persons who do not respond or have a sub- optimal response to a course of vaccinations.
Dożi żejda għandhom ikunu kkunsidrati għal dawk li ma jirrispondux jew ma jirrispondux biżżejjed għal xi kors ta ’ tilqim.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal vaċċini kollha li jingħataw b’ injezzjoni, għandu jingħata trattament mediku addattat u għandu jkun hemm sorveljanza dejjem lesta f’ każ rari ta ’ problemi anafilattiċi wara s- somministrazzjoni tal- vaċċin.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Peress li l- injezzjoni minn ġol- ġilda jew is- somministrazzjoni għal- ġol muskolu ġol - muskolu gluteali tista jikkawża rispons suboptimali għall - vaċċin, dawn il- metodi għandhom jiġu evitati.
However, exceptionally Twinrix Adult can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects (see section 4.2.).
(ara sezzjoni 4. 2)
TWINRIX ADULT SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVASCULARLY.
TWINRIX ADULT MA GĦANDU QATT JINGĦATA FIL- VINA
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Bħal fil- vaċċini l- oħra mhux kull min jitlaqqam ser ikollu r- rispons protettiv ta ’ l- immunita ’.
As with any injection procedure, vasovagal syncope can infrequently occur following administration of Twinrix Adult to adults and adolescents.
Bħal f’ kull proċedura ta ’ injezzjoni, jista ’ jkun hemm vasovagal syncope, b’ frekwenza baxxa, wara li Twinrix Adult jingħata lil adulti w adoloxxenti.
No data on concomitant administration of Twinrix Adult with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Għad ma hemmx tagħrif dwar l- amministrazzjoni ta ’ Twinrix Adult flimkien ma ’ l- immunoglobulina speċifika tal- epatite A jew B.
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
Madanakollu, meta l- vaċċin tal- epatite A jew B ingħataw ma immunoglobina speċifika ma rriżulta l- ebda bidla fis- serokonverżjoni għalkemm jista jirriżulta f’ livelli aktar baxxi ta ’ antikorpi.
Although the concomitant administration of Twinrix Adult and other vaccines has not specifically been studied, it is anticipated that, if different syringes and other injection sites are used, no interaction will be observed.
Għalkemm l- amministrazzjoni ta ’ Twinrix Adult flimkien ma vaċċini oħra m’ hijiex studjata, wieħed għandu jifhem li jekk jintużaw siringi differenti u siti ta ’ injezzjoni differenti ma għandux ikun hemm interazzjoni.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Wieħed jistenna li f’ pazjenti li qegħdin jingħataw kura immunosoppressiva jew pazjenti b’ immunita ’ baxxa, jista ma jintlaħaqx r- rispons adekwat.
The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats.
L- effett ta ’ Twinrix Adult fuq l- iżvilupp u s- sopravivenza ta ’ l- embriju/ fetu, waqt iż- żmien ta ’ qabel u wara l- ħlas u wara t- twelid, ġie assessjat fil- firien.
This study did not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/ fetal development, parturition or post-natal development.
Dan l- istudju ma wriex effetti ħżiena diretti jew indiretti fuq il - fertilità, fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju/ fetu, ħlas jew żvilupp wara t- twelid.
The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
L- effett ta ’ Twinrix Adult fuq l- iżvilupp u s- sopravivenza ta ’ l- embriju/ fetu, waqt iż- żmien ta ’ qabel u wara l- ħlas u wara t- twelid ma ġiex konsiderat b’ mod prospettiv fi provi kliniċi.
4 Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Adult on pregnancy or on the health of the fetus/ newborn child.
Tagħrif fuq l- eżitu ta ’ numru limitat ta ’ nisa tqal li ħadu l- vaċċin, ma juri l- ebda effett avvers ta ’ Twinrix Adult fuq it- tqala jew fuq is- saħħa tal- fetu/ tat- tarbija tat- twelid.
While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection.
4 tilqim jiġi pospost għal wara l- ħlas, sakemm ma jkunx hemm bżonn urġenti li tipproteġi l- omm kontra infezzjoni ta 'l- epatite B.
It is unknown whether Twinrix Adult is excreted in human breast milk.
Mhux magħruf jekk Twinrix Adult jgħaddix għal ġol- ħalib tas- sider.
The excretion of Twinrix Adult in milk has not been studied in animals.
L- eskrezzjoni ta ’ Twinrix Adult ġol - ħalib ma ’ ġietx studjata fl- annimali.
A decision on whether to continue/ discontinue breast- feeding or to continue/ discontinue therapy with Twinrix Adult should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Adult therapy to the woman.
Id- deċiżjoni fuq jekk wieħed għandux ikompli/ jwaqqaf it- treddigħ jew ikompli/ jwaqqaf it- terapija bi Twinrix Adult għandha tiġi bbażata fuq il- benefiċju tat- treddigħ għat- tarbija u l- benefiċju tat- terapija bi Twinrix Adult għall- mara.
4.7 Effects on the ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni.
Twinrix Adult has no or negligible influence on the ability to drive and use machines.
Twinrix Adult m’ għandu l’ ebda effett jew ftit li xejn effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
The current formulation of Twinrix does not contain thiomersal (an organomercuric compound) or any preservative.
Il- preparazzjoni t’ issa ta ’ Twinrix Adult ma ’ fihiex thiomersal (kompost organomerkurjali) jew preservattivi.
In a clinical study conducted with the current formulation, 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.
F’ studju kliniku bil- preparazzjoni t’ issa, il- frekwenza ta ’ uġigħ, ħmura, nefħiet, għeja, gastro - enterite, uġigħ ta ’ ras u deni kienet komparabbli mal- frekwenza osservata bil- preparazzjoni ta ’ qabel li kien fiha thiomersal u preservattivi.
The following undesirable effects have been reported following the widespread use of the former formulation.
L- effetti mhux mixtieqa li ġejjin ġew irrappurtati wara l- użu fuq medda wiesgħa tal- preparazzjoni ta ’ qabel.
The safety profile presented below is based on a pooled analysis of events per dose from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule (n=5,683) or the accelerated 0, 7, 21 days schedule (n=320).
Il- profil ta ’ sigurtà ppreżentat hawn taħt huwa bbażat fuq analiżi miġbura ta ’ effetti wara kull doża f’ aktar minn 6, 000 suġġett li ħadu l- iskeda standard ta ’ 0, 1, 6 xhur (n=5, 683) jew l- iskeda aċċelerata ta ’ 0, 7, 21 ġurnata (n=320).
In the two clinical trials in which Twinrix Adult was administered at 0, 7, 21 days, overall solicited general and local symptoms were reported with the same categories of frequency as defined below.
Fiż- żewġ provi kliniċi fejn Twinrix Adult ingħata fi żmien 0, 7, 21 ġurnata, s- sintomi ġenerali u lokali dokumentati ġew irrapurtati bl- istess kategoriji ta ’ frekwenza kif definit hawn taħt.
After a fourth dose given at month 12, the incidence of systemic and local adverse reactions was comparable to that seen after vaccination at 0, 7, 21 days.
Wara r - raba doża li ngħatat fix- xahar 12, l- inċidenza ta ’ reazzjonijiet fis- sistema u lokali kienet komparabbli ma dik ta ’ wara t- tilqim li ngħata ta ’ 0, 7, 21 ġurnata.
In comparative studies, it was noted that the frequency of solicited adverse events following the administration of Twinrix Adult is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines.
Il- frekwenzi ġew 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 Rari ħafna
Very rare:
< 1/ 10, 000
≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000 < 1/ 10,000
* jirreferi għal effetti mhux mixtieqa li ġew osservati fi provi kliniċi li saru bil- preparazzjoni pedjatrika
* refers to adverse reactions observed in clinical trials performed with the paediatric formulation
Rari: limfadenopatija
Blood and lymphatic system disorders Rare: lymphadenopathy
Disturbi fis- sistema nervuża Komuni ħafna: uġigħ ta ’ ras Mhux komuni: sturdament Rari: ipoestesija, tnemnim
Nervous system disorders Very common: headache Uncommon: dizziness Rare: hypoaesthesia, paraesthesia
Disturbi gastro- intestinali Komuni: sintomi gastro- intestinali, dijarrea, dardir Mhux komuni: rimettar, uġigħ addominali *
Gastrointestinal disorders
Distubi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Rari: raxx, ħakk
5 Common: gastrointestinal symptoms, diarrhoea, nausea Uncommon: vomiting, abdominal pain*
5 Rari ħafna: urtikarja
Musculoskeletal and connective tissue disorders Uncommon: myalgia Rare: arthralgia
Disturbi muskolu- skeltrali u tal- connective tissue Mhux komuni: majalġja Rari: artralġja
Metabolism and nutrition disorders Rare: decreased appetite
Disturbi fil- metaboliżmu u n- nutrizzjoni Rari: nuqqas t’ aptit
Infections and infestations Uncommon: upper respiratory tract infection
Infezzjonijiet u infestazzjonijiet Mhux komuni: infezzjoni fil- parti ta ’ fuq tas- sistema respiratorja
Vascular disorders Rare: hypotension
Disturbi vaskulari Rari: pressjoni baxxa
General disorders and administration site conditions Very common: pain and redness at the injection site, fatigue Common: swelling at the injection site, injection site reactions (such as haematoma, pruritus and bruising), malaise Uncommon: fever (≥ 37.5°C) Rare: influenza like illness, chills
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni ħafna: uġigħ u ħmura fis- sit ta ’ l- injezzjoni, għeja Komuni: nefħa fis- sit ta ’ l- injezzjoni, reazzjonijiet fis- sit ta ’ l- injezzjoni (bħal ematoma, ħakk u tbenġil), tħossok ma tiflaħx Mhux komuni: deni (≥ 37. 5°Ċ) Rari: sintomi bħal tal- influwenza, tkexkix ta ’ bard
The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
L- effetti mhux mixtieqa li ġejjin ġew irrappurtati wara Twinrix jew wara l- vaċċini separati tal- epatite A jew B ta ’ GlaxoSmithKline:
Blood and lymphatic system disorders Thrombocytopenia, thrombocytopenic purpura
Disturbi tad- demm u tas- sistema limfatika Tromboċitopenja, purpura tat- tromboċitopenja
Nervous system disorders Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions
Enkefalite, enkefalopatija, newrite, newropatija, paraliżi, aċċessjonijiet
Skin and subcutaneous tissue disorders Angioneurotic oedema, lichen planus, erythema multiforme
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Edema anġjonewrotika, lichen planus, eritema multiforme
Musculoskeletal and connective tissue disorders Arthritis, muscular weakness
Disturbi muskolu- skeltrali u tal- connective tissue Artrite, dgħjufija fil- muskoli
Infections and infestations Meningitis
Infezzjonijiet u infestazzjonijiet Meninġite
Vascular disorders Vasculitis
Disturbi vaskulari Vaskulite
Immune system disorders Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness
Disturbi fis- sistema immuni Anafilassi, reazzjonijiet allergiċi li jinkludu dawk simili għal attakk anafilattiku u li jixbħu serum sickness.
Following widespread use of the monovalent hepatitis A and/ or hepatitis B vaccines, the following undesirable events have additionally been reported in temporal association with vaccination.
Wara l- użu estensiv tal- vaċċini separati tal- epatite A u/ jew B, l- effetti mhux mixtieqa li ġejjin, ġew ukoll rappurati b’ assoċċjazzjoni temporali mal- vaċċinazzjoni.
6 Abnormal liver function tests
Investigazzjonijiet Testijiet seroloġiċi tal- fwied abnormali
Nervous system disorders Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), optic neuritis
Disturbi fis- sistema nervuża Sklerożi multipla, myelite, palsy tal- wiċċ, polynewrite bħall- marda ta ’ Guillain- Barre (b’ paraliżi li titla ’ l fuq), newrite ottika
Cases of overdose have been reported during post-marketing surveillance.
Każijiet ta ’ doża eċċessiva ġew rrappurtati waqt sorveljanza ta ’ wara t- tqegħid fis- suq.
Adverse events reported following overdosage were similar to those reported with normal vaccine administration.
Effetti mhux mixtieqa li ġew rrappurtati wara doża eċċessiva kienu simili għal dawk irrappurtati wara t- tilqim normali.
Hepatitis vaccines, ATC code J07BC20.
Kategorija farmakoterapewtika: vaċċini tal- epatite, ATC Kodiċi JO7BC20
Twinrix Adult is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Twinrix Adult huwa vaċċin kombinat ifformulat billi jinġemgħu preparazzjonijiet fuq skala kbira tal- virus tal- epatite A (HA) ippurifikat u inattivat u l- antiġenu ta ’ barra tal- epatite B ippurifikat (HbsAg), separatament adsorbiti fuq aluminium hyroxide u aluminium phosphate.
The HA virus is propagated in MRC5 human diploid cells.
Il- virus HA huwa ppropagat f’ ċelluli umani tat- tip diploid MRC5.
HBsAg is produced by culture, in a selective medium, of genetically engineered yeast cells.
HBsAg huwa prodott b’ kultura f’ taħlita selettiva, ta ’ ċelluli tal- ħmira mfassla ġenetikament.
Twinrix Adult confers immunity against HAV and HBV infection by inducing specific anti-HAV and anti-HBs antibodies.
Twinrix Adult tagħti immunita ’ kontra l- infezzjoni ta ’ HAV u HBV billi tinduċi antikorpi speċifiċi kontra HAV u HBs.
Protection against hepatitis A and hepatitis B develops within 2-4 weeks.
Il- protezzjoni kontra l- epatite A u B tiżviluppa f’ perjodu ta ’ bejn 2 u 4 ġimgħat.
Specific humoral antibodies against hepatitis B were observed in 70% of the adults after the first dose and approximately 99% after the third dose.
Fi studji kliniċi, l - antikorpi speċifiċi kontra l- epatite A ġew osservati f ’ madwar 94% tal- Adulti xahar wara l- ewwel doża u 100% xahar wara t- tielet doża (i. e. fis- seba xahar). Antikorpi speċifiċi kontra l- epatite B ġew osservati f ’ madwar 70% tal- Adulti wara l- ewwel doża u xi 99% wara t- tielet doża.
The 0, 7 and 21 day primary schedule plus a fourth dose at month 12 is for use in exceptional circumstances in adults.
L- iskeda primarja ta ’ 0, 7 u 21 ġurnata kif ukoll ir- raba doża fit- tnax il- xahar hija għall- użu f’ ċirkostanzi mhux tas- soltu fl- adulti.
In a clinical trial where Twinrix Adult was administered according to this schedule, 82% and 85% of vaccinees had seroprotective levels of anti-HBV antibodies at 1 and 5 weeks respectively following the third dose (i. e. at months 1 and 2 after the initial dose).
Fi provi kliniċi fejn Twinrix Adult ingħatat fuq din l- iskeda, 82% u 85% tal - persuni mlaqqma kellhom livelli seroprotettivi ta ’ antikorpi kontra l- epatite B fi żmien ġimgħa u ħames ġimgħat rispettivament mit- teħid tat- tielet doża (i. e. fl- ewwel u fit- tieni xahar wara l- ewwel doża).
The seroprotection rate against hepatitis B increased to 95.1% by three months after the first dose.
Ir- rata ta ’ seroprotezzjoni kontra l- epatite B żdiedet għal 95. 1% fi tlett xhur wara l- ewwel doża.
Seropositivity rates for anti-HAV antibodies were 100%, 99.5% and 100% at months 1, 2 and 3 after the initial dose.
Rati ta’ seroposittivita ’ tal- antikorpi kontra l- epatite A kienu ta’ 100%, 99. 5% u 100% fl- 1, 2, 3 xahar mit - teħid ta ’ l- ewwel doża.
One month after the fourth dose, all vaccinees demonstrated seroprotective levels of anti-HBs antibodies and were seropositive for anti-HAV antibodies.
Xahar wara it- teħid tar- raba doża, il- persuni mlaqqma kollha kellhom livelli seroprotettivi tal- antikorpi kontra HBs u kienu seroposittivi għall- antikorpi anti- HAV.
In a clinical study conducted in subjects over 40 years of age, the seropositivity rate for anti-HAV antibodies and seroprotection rate against hepatitis B of Twinrix Adult following a 0, 1, 6 months schedule were compared with the seropositivity and seroprotection rates of monovalent hepatitis A and B vaccines when administered in opposite arms.
F’ studju kliniku li sar f’ suġġetti ta ’ fuq l- erbgħajn sena, r- rata ta’ seroposittivita ’ tal- antikorpi anti- HAV u r - rata ta ’ seroprotezzjoni għal- epatite B ta ’ Twinrix Adult, wara skeda ta ’ 0, 1, 6 xhur ġew imqabbla ma ’ r- rati ta’ seroposittivita ’ u ta ’ seroprotezzjoni ta ’ vaċċini indipendenti kontra l- epatite A u l- epatite B meta dawn ingħataw f’ gruppi opposti.
The seroprotection rate against hepatitis B after the administration of Twinrix Adult was 92% and 87.5% at 7 and 12 months respectively, versus 80% and 74% after the GlaxoSmithKline Biologicals monovalent 20µg hepatitis B vaccine, and 71% and 56% after another licensed monovalent 10µg hepatitis B vaccine.
Ir- rata ta ’ seroprotezzjoni għal- epatite B wara li ngħatat Twinrix Adult kienet ta ’ 92% u 87. 5% fix- xhur 7 u 12 rispettivament, kontra rata ta ’ 80% u 74% għal vaċċin indipendenti għal- epatite B ta ’ 20µg ta ’ GlaxoSmithKline Biologicals, u 71% u 56% wara vaċċin indipendenti ieħor awtoriżżat għal- epatite B ta ’ 10µg.
However, anti-HBs antibody concentrations decreased as age and body mass index increased; they were also lower in male than in female subjects.
Madankollu, l- konċentrazzjoni tal- antikorpi anti- HB tnaqqset mat- tkabbir fl- eta 'u fl- indiċi tal- massa tal- ġisem; kienet ukoll aktar baxxa f’ suġġetti ta ’ sess maskili minn f’ dawk femminili.
The seropositivity rate for anti-HAV antibodies after Twinrix Adult was 97% and 96% at 7 and 12 months respectively versus 99% and 98% after the GlaxoSmithKline Biologicals monovalent hepatitis A vaccine and 99% at both 7 and 12 months after another licensed monovalent hepatitis A vaccine.
Ir- rata ta’ seroposittivita ’ tal- antikorpi anti- HAV wara Twinrix Adult kienet ta ’ 97% u 96% fix- xhur 7 u 12 rispettivament kontra 99% u 98% wara l- vaċċin indipendenti kontra l- epatite A ta 'GlaxoSmithKline Biologicals u 99% fix- xhur 7 u 12 wara vaċċin indipendenti ieħor awtoriżżat għal- epatite A.
7 In two long term clinical studies conducted in adults, persistence of anti-HAV and anti-HBs antibodies has been proven up to 60 months following the initiation of a primary vaccination course of Twinrix Adult in the majority of vaccinees.
F ’ żewġ studji kliniċi meħudha fit- tul fl- adulti, il- peristenza tal- antikorpi anti- HAV u anti- HBs ġiet ippruvata sa 60 xahar mill- bidu tal- kors primarju ta ’ tilqim bi Twinrix Adult fil- biċċa l- kbira ta ’ dawk mlaqqma.
The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.
Il- kinetika ta ’ kif jonqsu l- livelli tal- antikorpi kienet tixbaħ lil dik tal- vaċċini indipendenti.
These data were generated with the former Twinrix formulation containing thiomersal and a preservative.
7 Dan it- tagħrif ġie miġbur bil- preparazzjoni ta ’ qabel ta ’ Twinrix li kien fiha thiomersal u preservattiv.
A clinical study conducted with the current formulation of Twinrix in adults showed that the current formulation elicited similar seroprotection and seroconversion rates as compared to the former formulation.
Studju klinku fl- adulti li sar bil- preparazzjoni t’ issa ta ’ Twinrix wera li l- preparazzjoni t’ issa ġabet l- istess rati ta ’ seroprotezzjoni u serokonversjoni meta mqabbla mal- preparazzjoni ta ’ qabel.
Evaluation of pharmacokinetic properties is not required for vaccines.
Evalwazzjoni ta ’ karatteristiċi farmakokinetiċi mhix meħtieġa għall- vaċċini.
Non-clinical data reveal no special hazard for humans based on general safety studies (see section 4.6).
Tagħrif mhux klinikali ma juri l- ebda periklu speċjali għall- bnedmin fuq bażi ta ’ studji ġenerali (ara sezzjoni 4. 6).
PHARMACEUTICAL PARTICULARS
TAGĦRIF FARMAKOĊEWTIKU
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u dak li hemm ġo fih
1 ml of suspension in a vial (type I glass) with a plunger stopper (rubber butyl).
1 millilitru ta ’ suspensjoni fi fjala (ħġieġ tip I) magħluqha bi planġer (lakstu butyl).
Pack sizes of 1, 10 and 25.
Pakketti ta ’ 1, 10 jew 25.
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal- skop kummerċjali.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar iehor
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Meta jkun maħżun, depożitu fin u abjad u saff ċar bla kulur fil- wiċċ jistgħu jifformaw.
8 The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Il- vaċċin għandu jiġi mħallat sewwa biex tinkiseb suspensjoni bajdanija w opaka u għandu jkun mifli sew għal xi partiċelli barranin u / jew xi tibdil fl- aspett fiżiku qabel ma jintuża.
In the event of either being observed, discard the vaccine.
F’ każ li jiġri hekk, m’ għandux jintuża.
Any unused product of waste material should be disposed of in accordance with local requirements.
Kull fdal ta ’ prodott li ma jkunx intuża jew skart li jibqa ’ wara għandu jintrema kif jitolbu l- liġijiet lokali
GlaxoSmithKline Biologicals s. a. rue de l'Institut 89 B-1330 Rixensart, Belgium
GlaxoSmith Kline Biologicals s. a Rue de l’ Institut 89 B- 1330 Rixensart, Belgium
20 September 1996 Date of latest renewal:
20 ta ’ Settembru 1996 Data ta ’ l- aħħar tiġdid:
Twinrix Adult, suspension for injection in prefilled syringe Hepatitis A (inactivated) and hepatitis B(rDNA) (HAB) vaccine (adsorbed).
Twinrix Adult, suspensjoni għall- injezzjoni f’ siringa preparata Vaċċin (adsorbit) tal- epatite A (inattivat) u epatite B (rDNA) (HAB).
QUALITATIVE AND QUANTITATIVE COMPOSITION
L- GĦAMLA KWALITATTIVA U KWANTITATTIVA
PHARMACEUTICAL FORM
L- GĦAMLA FARMAĊEWTIKA
Suspension for injection in prefilled syringe Turbid white suspension
Is- suspensjoni hija bajda u mdardra.
Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Twinrix Adult huwa indikat għall- użu f’ adulti u adoloxxenti ta ’ l- fuq minn 16 il- sena li ma jkollhomx l - immunita ’ relevanti u li huma fir- riskju ta ’ infezzjoni mill- epatite A kif ukoll mill- epatite B.
A dose of 1.0 ml is recommended for adults and adolescents 16 years of age and above.
Doża ta’ 1. 0 millilitru hija irrakkomandata għal adulti u adoloxxenti ta ’ l- fuq minn 16 il- sena.
The standard primary course of vaccination with Twinrix Adult consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose.
Il- kors primarju bażiku ta ’ tilqim bi Twinrix Adult jikkonsisti fi tlett dożi, ta ’ l- ewwel amministrata fid- data mixtieqa, it- tieni xahar wara, u t- tielet sitt xhur wara l- ewwel doża.
In exceptional circumstances in adults, when travel is anticipated within one month or more after initiating the vaccination course, but where insufficient time is available to allow the standard 0, 1, 6 month schedule to be completed, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used.
F’ ċirkostanzi speċjali fl- adulti, meta qieghed jiġi ppjanat xi vjaġġar fi żmien xahar jew aktar mill- bidu tal - kors tal- vaċċinazzjoni, iżda fejn ma hemmx żmien biżżejjed sabiex tinżamm l- iskeda bażika ta ’ 0, 1, 6 xhur tiġi kompluta, skeda ta ’ tliet injezzjonijiet għal ġol- muskoli mogħtija fi żmien 0, 7 u 21 ġurnata tista tingħata.
When this schedule is applied, a fourth dose is recommended 12 months after the first dose.
Meta tiġi applikata din l- iskeda, ir- raba doża hija rrakkommandata tnax- il- xahar wara it- teħid tal - ewwel doża.
Long-term antibody persistence data following vaccination with TWINRIX Adult are available up to 60 months after vaccination.
Hemm informazzjoni fuq il- persistenza tal- antikorp wara tilqima bi Twinrix Adult sa 60 xahar wara t - tilqima.
The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Il- livelli tal- antikorpi anti- HBs u anti- HAV osservati wara kors primarju ta ’ vaċċinazzjoni bil - vaċċin kombinat huma fl- istess saff ta’ dawk wara t- tilqima bil- vaċċini individwali.
The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established; however some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
Il- bżonn ta ’ doża ta ’ rinforz bil- vaċċin tal- epatite B f’ individwi f’ saħħithom li rċevew kors sħiħ ta ’ vaċċin primarju għadu ma ġiex stabbilit; madanakollu wħud mill- programmi uffiċjali ta ’ vaċċinazzjoni bħalissa jinkludu rakkomandazzjoni ta ’ vaċċin ta ’ doża ta ’ rinforz tal- epatite B u dawn għandhom ikunu rispettati.
Alternatively, subjects primed with Twinrix Adult may be administered a booster dose of either of the monovalent vaccines.
Jew inkella, suġġetti mibdija bi Twinrix Adult jistgħu jingħataw doża ta ’ rinforz b’ waħda mill - vaċċini individwali.
Twinrix Adult is for intramuscular injection, preferably in the deltoid region.
Twinrix Adult jingħata b ’ injezzjoni ġol- muskoli, l- aħjar fil- muskolu deltoid.
Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
F’ każijiet rari, il- vaċċin għandu jingħata taħt il- ġilda f’ pazjenti b’ nuqqas ta ’ pjastrini jew fejn id- demm ma jkunx għaqad sew.
The administration of Twinrix Adult should be postponed in subjects suffering from acute severe febrile illness.
L- użu ta ’ Twinrix Adult għandu jiġi pospost f’ suġġetti li għandhom mard li jagħti deni akut u serju ħafna.
It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
Jista jkun li fil- ħin tat- tilqima is- suġġett ikun fil- perjodu ta ’ inkubazzjoni tal - marda epatite A jew B.
It is not known whether Twinrix Adult will prevent hepatitis A and hepatitis B in such cases.
M’ huwiex magħruf jekk Twinrix Adult iwaqqafx l- epatite A u B f’ dawn il- każijiet.
11 Twinrix Adult is not recommended for postexposure prophylaxis (e. g. needle stick injury).
Twinrix Adult mhux rakkomandat għal prevenzjoni ta ’ wara l- esposizzjoni għall- virus (eż tniggist b’ labbra użata).
The vaccine has not been tested in patients with impaired immunity.
11 Il- vaċċin ma ġiex ippruvat fuq pazjenti b’ immunita ’ baxxa.
A number of factors have been observed to reduce the immune response to hepatitis B vaccines.
Hemm xi fatturi li jnaqqsu r- rispons ta ’ l- immunita ’ għall - vaċċini ta ’ l- epatite B.
These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases.
Dawn jinkludu eta ’ avvanzata, sess maskili, obeżità, tipjip, rotta ta ’ kif għandu jingħata, u xi mard kroniku.
Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Twinrix Adult.
Wieħed għandu jikkonsidra jagħmel xi eżamijiet seroloġiċi f’ dawk li għandhom riskju li ma jilħqux seroprotezzjoni wara kors sħiħ ta ’ Twinrix Adult.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Peress li l- injezzjoni għal ġol- ġilda jew is- somministrazzjoni għal ġol- muskoli ġol- muskolu gluteali jista jikkawża rispons suboptimali għall- vaċċin, dawn il- metodi għandhom jiġu evitati.
No data on concomitant administration of Twinrix Adult with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Għad ma hemmx tagħrif dwar l- amministazzjoni ta ’ Twinrix Adult flimkien ma l- immunoglobulina speċifika tal- epatite A jew B.
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
Madanakollu, meta l- vaċċin tal- epatite A jew B ingħataw ma immunoglobina speċifika ma rriżulta l- ebda bidla fis- serokonverżjoni ġħalkemm jista jirriżulta f’ livelli aktar baxxi ta ’ antikorpi.
Although the concomitant administration of Twinrix Adult and other vaccines has not specifically been studied, it is anticipated that, if different syringes and other injection sites are used, no interaction will be observed.
Għalkemm l- amministrazzjoni ta ’ Twinrix Adult flimkien ma vaċċini oħra m’ hijiex studjatha, wieħed għandu jifhem li jekk jintużaw siringi differnti u siti ta ’ injezzjoni differenti ma għandux ikun hemm interazzjoni.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Wieħed jistenna li f’ pazjenti li qegħdin jingħataw kura immunosoppressiva jew pazjenti b’ immunita ’ baxxa, jista ma jintlaħaqx rispons adekwat.
12 Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Adult on pregnancy or on the health of the fetus/ newborn child.
Tagħrif fuq l- eżitu ta ’ numru limitat ta ’ nisa tqal li ħadu l- vaċċin, ma juri l- ebda effett avvers ta ’ Twinrix Adult fuq it- tqala jew fuq is- saħħa tal- fetu/ tat- tarbija tat- twelid.
While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection.
12 tilqim jiġi pospost għal wara l- ħlas, sakemm ma jkunx hemm bżonn urġenti li tipproteġi l- omm kontra infezzjoni ta 'l- epatite B.
Twinrix Adult has no or negligible influence on the ability to drive and use machines.
Twinrix Adult m ’ għandu l’ ebda effett jew ftit li xejn effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
In comparative studies, it was noted that the frequency of solicited adverse events following the administration of Twinrix Adult is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines.
F’ studji komparattivi ntwera li l- frekwenza ta ’ effeti avversi dokumentati wara tilqima bi Twinrix Adult ma kienitx differenti minn dik ta ’ wara tilqima bil- vaċċini separati.
≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000 < 1/ 10,000
Il- frekwenzi ġew 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 Rari ħafna
* refers to adverse reactions observed in clinical trials performed with the paediatric formulation
* jirreferi għal effetti mhux mixtieqa li ġew osservati fi provi kliniċi li saru bil- preparazzjoni pedjatrika
Blood and lymphatic system disorders Rare: lymphadenopathy
Rari: limfadenopatija
Nervous system disorders Very common: headache Uncommon: dizziness Rare: hypoaesthesia, paraesthesia
Disturbi fis- sistema nervuża Komuni ħafna: uġigħ ta ’ ras Mhux komuni: sturdament Rari: ipoestesija, tnemnim
Gastrointestinal disorders
Disturbi gastro- intestinali Komuni: sintomi gastro- intestinali, dijarrea, dardir Mhux komuni: rimettar, uġigħ addominali *
13 Common: gastrointestinal symptoms, diarrhoea, nausea Uncommon: vomiting, abdominal pain*
13 Distubi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Rari: raxx, ħakk Rari ħafna: urtikarja
Investigations
Disturbi fis- sistema nervuża
14 Abnormal liver function tests
14 Sklerożi multipla, myelite, palsy tal- wiċċ, polynewrite bħall- marda ta ’ Guillain- Barre (b’ paraliżi li titla ’ l fuq), newrite ottika
5.1 Pharmacodynamic properties
5. 1 Farmakodinamika tal- prodott
Twinrix Adult is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Twinrix Adult huwa vaċċin kombinat ifformulat billi jinġemgħu ppreparazzjonijiet fuq skala kbira tal- virus ta ’ l- epatite A (HA) ippurifikat u inattivat u l- antiġenu ta ’ barra tal- epatite B ippurifikat (HbsAg), separatament adsorbiti fuq aluminium hyroxide u aluminium phosphate.
HBsAg is produced by culture, in a selective medium, of genetically engineered yeast cells.
HBsAg huwa prodott b’ kultura f’ taħlita selettiva, ta ’ ċelluli tal- ħmira mfassla genetikament.
In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 94% of the adults one month after the first dose and in 100% one month after the third dose (i. e. month 7).
Fi studji kliniċi, l - antikorpi speċifiċi kontra l- epatite A ġew osservati f ’ madwar 94% tal- Adulti xahar wara l- ewwel doża u 100% xahar wara t- tielet doża (i. e. fis- seba ’ xahar).
Specific humoral antibodies against hepatitis B were observed in 70% of the adults after the first dose and approximately 99% after the third dose.
Antikorpi speċifiċi kontra l- epatite B ġew osservati f ’ madwar 70% tal- Adulti wara l- ewwel doża u 99% wara t- tielet doża.
Seropositivity rates for anti-HAV antibodies were 100%, 99.5% and 100% at months 1, 2 and 3 after the initial dose.
Rati ta’ seroposittivita ’ tal- antikorpi kontra l- epatite A kienu ta’ 100%, 99. 5% u 100% fl- 1, 2, 3 xahar mit- teħid ta ’ l- ewwel doża.
However, anti-HBs antibody concentrations decreased as age and body mass index increased; they were also lower in male than in female subjects.
Madankollu, l- konċentrazzjoni tal- antikorpi anti- HB tnaqqset ma ’ t- tkabbir fl- eta 'u fl- indiċi tal- massa tal- ġisem; kienet ukoll aktar baxxa f’ suġġetti ta ’ sess maskili minn f’ dawk femminili.
15 In two long term clinical studies conducted in adults, persistence of anti-HAV and anti-HBs antibodies has been proven up to 60 months following the initiation of a primary vaccination course of Twinrix Adult in the majority of vaccinees.
F’ żewġ studji kliniċi meħudha fit- tul fl- adulti, il- peristenza tal- antikorpi anti- HAV u anti- HBs ġiet ippruvata sa 60 xahar mill- bidu tal- kors primarju ta ’ tilqim bi Twinrix Adult fil- biċċa l- kbira ta ’ dawk mlaqqma (ara 4. 2).
The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.
Il - kinetika ta ’ kif jonqsu l- livelli tal- antikorpi kienet tixbaħ lil dik tal- vaċċini indipendenti.
These data were generated with the former Twinrix formulation containing thiomersal and a preservative.
15 Dan it- tagħrif ġie miġbur bil- preparazzjoni ta ’ qabel ta ’ Twinrix li kien fiha thiomersal u preservattiv.
1 ml of suspension in a prefilled syringe (type I glass) with a plunger stopper (rubber butyl).
1 millilitru ta ’ suspensjoni f ’ siringa mimlija lesta (ħġieġ tip I) magħluqha bi planġer (gomma butyl)
Pack sizes of 1, 10 and 25 with or without needles.
Pakketti ta ’ 1, 10 u 25 bil- labar jew mingħajrhom.
Not all pack sizes may be marketed.
Mhux il- pakketti ta ’ kull qies jistgħu jkunu għal- skop kummerċjali.
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Meta jkun maħżun, depożitu fin u abjad u medda ċara bla kulur tista tifforma fil- wiċċ.
16 The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Il- vaċċin għandu jiġi mħallat sewwa biex tinkiseb suspensjoni bajdanija w opaka u għandu jkun mifli sew għal xi pariċelli barranin u/ jew xi tibdil fl- aspett fiżiku qabel ma jintuża.
Any unused product of waste material should be disposed of in accordance with local requirements.
16 Kull fdal ta ’ prodott li ma jkunx intuża jew skart li jibqa ’ wara għandu jintrema kif jitolbu l- liġijiet lokali
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substances
Isem u indirizz tal- manifattur( i) tas- sustanza( i) bijoloġika( ċi) attiva( i)
The Marketing Authorisation Holder will continue to submit annual PSURs.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jkompli jissottometti PSURs kull sena.
Twinrix Adult – Suspension for injection Hepatitis A (inactivated) and hepatitis B(rDNA) (HAB) vaccine (adsorbed).
Twinrix Adult – Suspensjoni għall- injezzjoni Vaċċin (adsorbit) tal- epatite A (inattivat) u epatite B (rDNA) (HAB).
1 dose (1 ml):
Doża 1 (1millilitru):
Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4 Adsorbed on aluminium phosphate
0. 05 milligrammi A13+ Adsorbit fuq aluminium hydroxide, idratat 3 Manifatturat fuq ċelluli tal- ħmira (Saccharomyces cerevisiae) b’ teknoloġija rikombinanti tad- DNA 4 0. 4 milligrammi A13+ Adsorbit fuq aluminium phosphate
Suspension for injection 1 vial 1 dose (1 ml)
Suspensjoni għall- injezzjoni Fjala Doża 1 (1 millilitru)
MM/ YYYY
JIS [XX/ SSSS]
Rue de l’ Institut 89 B-1330 Rixensart, Belgium
GlaxoSmithKline Biologicals s. a Rue de l’ Institut 89 B- 1330 Rixrnsart, Belgium
Suspension for injection 10 vials 10 x 1 dose 1 dose (1 ml)
Suspensjoni għall- injezzjoni 10 fjali 10 x Doża 1 Doża 1 (1 millilitru)
EXP:
24 JIS:
Suspension for injection 25 vials 25 x 1 dose 1 dose (1 ml)
Suspensjoni għall- injezzjoni 25 fjala 25 x Doża 1 Doża 1 (1 millilitru)
MM/ YYYY
26 Jis MM/ YYYY
Suspension for injection 1 syringe 1 dose (1 ml)
Suspensjoni għall- injezzjoni Siringa 1 Doża 1 (1 millilitru)
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
TWISSIJA SPEĊJALI GĦAR - RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
Suspension for injection 10 syringes 10 x 1 dose 1 dose (1 ml)
Suspensjoni għall- injezzjoni 10 siringi 10 x Doża 1 Doża 1 (1 millilitru)
MM/ YYYY
30 Jis MM/ YYYY
Suspension for injection 25 syringes 25 x 1 dose 1 dose (1 ml)
Suspensjoni għall- injezzjoni 25 siringa 25 x Doża 1 Doża 1 (1 millilitru)
EXP:
32 JIS:
Rue de l’ Institut 89 B-1330 Rixensart, Belgium
GlaxoSmithKline Biologicals s. a Rue de l’ Institut 89 B- 1330 Rixensart, Belgium
Suspension for injection 1 syringe 1 needle 1 dose (1 ml)
Suspensjoni għall- injezzjoni Siringa 1 Labra 1 Doża 1 (1 millilitru)
EXP:
34 JIS:
Suspension for injection 10 syringes 10 needles 10 x 1 dose 1 dose (1 ml)
Suspensjoni għall- injezzjoni 10 siringi 10 labar 10 x Doża 1 Doża 1 (1 millilitru)
MM/ YYYY
Jis MM/ YYYY
Suspension for injection 25 syringes 25 needles 25 x 1 dose 1 dose (1 ml)
Suspensjoni għall- injezzjoni 25 siringa 25 labra 25 x Doża 1 Doża 1 (1 millilitru)
38 EXP:
38 JIS:
39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
39 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Twinrix Adult, suspension for injection HAB vaccine I. M.
Twinrix Adult, suspensjoni għall- injezzjoni Vaċċin tal- HAB I. M.
1 dose (1 ml)
Doża 1 (1 millilitru)
Twinrix Adult, Suspension for injection Hepatitis A (inactivated) and hepatitis B(rDNA) (HAB) vaccine (adsorbed)
Twinrix Adult, Suspensjoni għall- injezzjoni Vaċċin (adsorbit) tal- epatite A (inattivat) u epatite B (rDNA) (HAB)
Read all of this leaflet carefully before you start receiving this vaccine.
Aqra dan il - fuljett kollu qabel tibda tingħata dan il - vaċċin
You may need to read it again.
Jista jkun hemm bżonn li terġa taqrah.
What Twinrix Adult is and what it is used for 2.
X’ inhu Twinrix Adult u għal xiex jintuża 2.
Before you receive Twinrix Adult 3.
Qabel ma inti tieħu Twinrix Adult 3.
How Twinrix Adult is given 4.
Kif Twinrix Adult għandu jingħata 4.
Possible side effects 5.
X’ effetti sekondarji jista ’ jkollu 5.
How to store Twinrix Adult 6.
Kif taħżen Twinrix Adult 6.
WHAT TWINRIX ADULT IS AND WHAT IT IS USED FOR
X’ INHU TWINRIX ADULT U GĦALXIEX JINTUŻA
Twinrix Adult is a vaccine used in adults and adolescents 16 years of age and above to prevent two diseases: hepatitis A and hepatitis B.
Twinrix Adult huwa vaċċin li jintuża fl- adulti u adoloxxenti ta ’ l- fuq minn 16- il- sena sabiex jipproteġi minn żewġ mardiet: epatite A u epatite B.
The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Il - vaċċin jaħdem billi jgiegħel lill- ġisem jipproduċi protezzjoni (l - antikorpi) kontra dawn il- mard.
• Hepatitis A:
• Epatite A:
Hepatitis A is an infectious disease, which can affect the liver.
L- epatite A hija marda infettiva li jista jkollha effetti fuq il- fwied.
This disease is caused by the hepatitis A virus.
Din il- marda hija kawżata mill - virus tal - epatite A.
The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage.
Dan il- virus jista jittieħed minn persuna għall- oħra fl- ikel u x- xorb, jew bl- għawm f’ ilma ikkontaminat mid- dranaġġ.
Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus.
Is- sintomi tal- epatite A jibdew 3 jew sitt ġimgħat wara li tkun ġejt f’ kuntatt mall- virus.
These consist of nausea (feeling sick), fever and aches and pains.
Dawn jikkonsistu f’ nawżea (ma tkunx f’ siktek), deni kif ukoll uġigħ ‘ l hawn u ‘ l hemm.
After a few days the whites of eyes and skin may become yellowish (jaundice).
Wara xi jiem l- abjad ta ’ l- għajnejn u l- ġilda għandhom mnejn jisfaru (suffejra).
The severity and type of symptoms can vary.
Is- sintomi u s- severita ’ jistgħu jvarjaw.
Young children may not develop jaundice.
Tfal żgħar jistgħu ma jkollhomx suffejra.