qanastek/EMEA-V3 huggingface dataset:
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 jirkupraw kompletament, għalkemm l- marda taf tkun qawwija biżżejjed li żżomm lin - nies ma jifilħux għal madwar xahar.
Hepatitis B is caused by the hepatitis B virus.
L- epatite B hija kawżata mill- virus tal- epatite B.
It causes the liver to become swollen (inflamed).
Tikkawża l- infieħ tal- fwied (infjammat).
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Il- virus jinstab fil- fluwidi tal- ġisem bħal demm, semen, tisfija tal - vaġina, jew saliva (bżiq) ta ’ nies infettati.
Vaccination is the best way to protect against these diseases.
Il- vaċċinazzjoni hija l- aħjar mezz sabiex tipproteġi kontra dawn il- mard.
None of the components in the vaccine are infectious.
L- ebda komponent tal- vaċċin ma hu infettiv.
BEFORE YOU RECEIVE TWINRIX ADULT
QABEL MA TIEĦU TWINRIX ADULT
Twinrix Adult should not be given:
Twinrix Adult m’ għandux jingħata:
• if you have previously had any allergic reaction to Twinrix Adult, or any ingredient contained in this vaccine.
• jekk int kellek xi reazzjonijiet allerġiċi għal Twinrix Adult, jew għal xi ingredjent tal- vaċċin.
The active substances and other ingredients in Twinrix Adult are listed at the end of the leaflet.
Is - sustanzi attivi u l- ingredjenti l- oħra li jinstabu fi Twinrix Adult huma mniżżlin 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 previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases. • if you have a severe infection with a high temperature (over 38°C).
Is- sinjali ta ’ xi allerġija jistgħu jinkludu, raxx tal- ġilda bil- ħakk, qtugħ ta ’ nifs, u nefħa fil - wiċċ u fl- ilsien. • jekk int kellek xi reazzjonijiet allerġiċi għal xi vaċċin kontra l- marda tal- epatite A u l- epatite B. jekk int għandek xi infezzjoni serja b’ deni għoli (l- fuq minn 380C).
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Xi infezzjoni ħafifa bħal xi riħ • m’ għandiex tkun problema iżda qabel ikkonsulta mat- tabib.
42 Take special care with Twinrix Adult:
42 Oqgħod attent ħafna bi Twinrix Adult:
• if you have experienced any health problems after previous administration of a vaccine. • if you have a poor immune system due to illness or drug treatment. • if you have a bleeding problem or bruise easily.
• jekk int qatt kellek xi problemi relatati mas- saħħa wara xi tilqima. • jekk għandek immunita ’ baxxa minħabba xi mard jew xi kura medika. • jekk għandek problemi biex jagħqad id- demm jew titbenġel malajr.
A poor response to the vaccine, possibly without achieving protection against hepatitis A, has been observed in obese people.
Rispons dgħajjef għall- vaċċin li jista ma jwassalx għal protezzjoni kontra l- epatite A, ġie osservat f’ persuni li għandhom piż żejjed.
A poor response to the vaccine, possibly without achieving protection against hepatitis B, has also been observed in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Rispons dgħajjef għall- vaċċin li jista ma jwassalx għal protezzjoni kontra l- epatite B, ġie osservat ukoll fl- anzjani, fl- irġiel iktar milli fin- nisa, f’ min ipejjep, f’ min għandu piż żejjed, u f’ nies b’ mard kroniku jew dawk fuq xi tipi ta’ trattamenti mediċi.
Your doctor may advise you to have a blood test after you have completed the course of vaccinations to check if you have made a satisfactory response.
It- tabib tiegħek għandu mnejn jagħmillek xi eżami tad- demm wara li tlesti l- kors tat- tilqim biex jara jekk kellekx rispons adekwat.
If not, your doctor will advise you on the possible need to have extra doses.
Jekk le, t- tabib jagħtik parir dwar il- bżonn għal dożi oħra.
Using other medicines or vaccines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Meta tuża mediċini jew vaċċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, jew jekk ħadt xi tilqim ieħor dan l- aħħar
Pregnancy and breast-feeding Take special care with Twinrix Adult if you are or think you may be pregnant or if you intend to become pregnant.
Tqala u Treddigħ Oqgħod attenta ħafna jekk inti tqila jew jekk taħseb li inti tqila jew qed tippjana li toħroġ tqila.
Your doctor will discuss with you the possible risks and benefits of having Twinrix Adult during pregnancy.
It- tabib tiegħek għandu jiddiskuti miegħek ir- riskji u l- benefiċċji ta ’ Twinrix Adult waqt it- tqala.
It is not known if Twinrix Adult passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.
M’ hux magħruf jekk Twinrix Adult jgħaddix għal ġol- ħalib, iżda mhux mistenni li l- vaċċin jikkawża problemi fi trabi li qed jitreddgħu.
Important information about some of the ingredients of Twinrix Adult Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Twinrix Adult Jekk jogħġbok għid lit- tabib tiegħek jekk qatt kellek xi reazzjoni allerġika għal neomycin (antibijotiku)
HOW TWINRIX ADULT IS GIVEN
KIF GĦANDEK TIEĦU TWINRIX ADULT
You will receive a total of three injections over 6 months.
Inti għandek tirċievi tliet injezzjonijiet fi żmien sitt xhur.
Each injection is given on a separate visit.
Kull injezzjoni tiġi mogħtija waqt żjara separata.
The first dose will be given on an elected date.
L- ewwel doża tiġi mogħtija fid- data magħżula.
The remaining two doses will be given one month, and six months after the first dose.
Iż- żewġ dożi li jkun għad baqa ’ jingħataw fi żmien xahar, u fi żmien sitt xhur wara l- ewwel doża.
• • •
• L- ewwel doża: fid- data magħżula • It- tieni doża: xahar wara • It- tielet doża:
at an elected date 1 month later 6 months after the first dose
6 xhur wara l- ewwel doża.
Twinrix Adult can also be given as a total of three doses over 1 month.
Twinrix Adult jista ’ jingħata ukoll bħala total ta ’ tliet dożi fi żmien xahar wieħed.
This schedule may be given to adults only needing a rapid protection (e.g. overseas travellers).
Din l- iskeda tista ’ tingħata biss lill- adulti li għandhom bżonn ta ’ protezzjoni mingħajr dewmin (eż. persuni li se jivjaġġaw barra l- pajjiż).
The first dose will be given on an elected date.
L- ewwel doża tingħata fid- data magħżula.
The remaining 2 doses will be given 7 days and 21 days after the first dose.
Iż- żewġ dożi l- oħra jingħataw fi żmien 7 ijiem u fi żmien 21 ġurnata wara l- ewwel doża.
A fourth dose is recommended at 12 months.
Ir- raba doża hija rakkommandata fi żmien sena.
Second dose:
L- ewwel doża:
Fourth dose:
It- tieni doża It- tielet doża Ir- raba doża
at an elected date 7 days later 21 days after the first dose 12 months after the first dose
f’ data magħżula 7 ijiem wara 21 ġurnata wara l- ewwel doża 12 il- xahar wara l- ewwel doża
Your doctor will advise on the possible need for extra doses, and future booster dosing.
It- tabib jinfurmak dwar xi dożi oħra jekk ikun hemm bżonn, u għal aktar dożi ta ’ rinforz fil- futur.
As indicated in Section 2, a poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Kif hemm indikat f’ sezzjoni 2, r- rispons inadekwat għall- vaċċin mingħajr ma tintlaħaq il- protezzjoni mixtieqa huwa aktar komuni fl- anzjani, fl- irġiel aktar milli fin- nisa, f’ min ipejjep, f’ min għandu piż żejjed, u f’ nies b’ mard kroniku jew f’ nies fuq xi tip ta’ kura medika.
Your doctor may advise you to have a blood test after you have completed the course of vaccinations to check if you
Jekk tfalli xi injezzjoni skedata, kellem lit- tabib tiegħek u għamel appuntament ieħor.
43 have made a satisfactory response.
43 Kun żgur li tispiċċa il- programm kollu tat- tlett vaċċinazzjoniet.
If not, your doctor will advise you on the possible need to have extra doses.
Jekk le, int tista ’ ma tkunx protett kontra dan il- mard.
If not, you may not be fully protected against the diseases.
It- tabib jagħtik Twinrix Adult bħala injezzjoni fil- muskolu tan- naħa ta ’ fuq ta ’ driegħek.
The vaccine should not be given (deep) into the skin or intramuscularly into the buttock because protection may be less.
Il- vaċċin m’ għandux jingħata fil- ġilda (fil- fond) jew fil- muskolu tal- warrani għax il- protezzjoni tista ’ tkun anqas.
The vaccine should never be given into a vein.
Il- vaċċin ma għandu qatt jingħata ġol- vina.
Like all medicines, Twinrix Adult can cause side effects, although not everybody gets them.
Komuni ħafna (Dawn jistgħu jseħħu f’ 1 minn kull 10 dożi jew aktar tal- vaċċin): • Uġigħ ta ’ ras • Uġigħ u ħmura fis- sit ta ’ l- injezzjoni • Għeja
Side effects that may occur are the following:
Komuni (Dawn jistgħu jseħħu f’ sa 1 minn kull 10 dożi tal- vaċċin): • Dijarrea, dardir • Nefħa, tbenġil jew ħakk fis- sit ta ’ l- injezzjoni • Tħossok ma tiflaħx f' mod ġenerali
Very common (These may occur in 1 in 10 doses or more of the vaccine): • Headache • Pain and redness at the injection site • Tiredness Common (These may occur in up to 1 in 10 doses of the vaccine): • Diarrhoea, nausea • Swelling, bruising or itching at the injection site • Generally feeling unwell Uncommon (These may occur in up to 1 in 100 doses of the vaccine): • Dizziness • Vomiting, stomach pain • Aching muscles • Upper respiratory tract infection • Fever equal to or greater than 37.5°C Rare (These may occur in up to 1 in 1,000 doses of the vaccine): • Swollen glands in the neck armpit or groin (lymphadenopathy) • Loss of skin sensitivity to pain or touch (hypoaesthesia) • Feeling of pins and needles (paraesthesia) • Rash, itching • Joint pain • Loss of appetite • Low blood pressure • Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills Very rare (These may occur in up to 1 in 10,000 doses of the vaccine):
Rari (Dawn jistgħu jseħħu f’ sa 1 minn kull 1, 000 doża tal- vaċċin): • Glandoli ta ’ l- għonq jew fl- irqiq ta ’ bejn il- koxxa u ż- żaqq minfuħa (limfadenopatija) • Nuqqas ta ’ sensittività fil- ġilda għas- sħana jew għal- mess (ipoestesija) • Tnemnim (paraestesija) • Raxx, ħakk • Uġigħ fil- ġogi • Nuqqas ta ’ aptit • Pressjoni baxxa • Sintomi bħal tal- influwenza bħal deni ogħli, mard tal- gerżuma, mnieħer inixxi, sogħla u tkexkix ta ’ bard
Side effects occurred very rarely during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines include: • Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia) • Purple or red brown spots visible through the skin(thrombocytopenic purpura) • Swelling or infection of the brain (encephalitis) • Degenerative disease of the brain (encephalopathy) • Inflammation of nerves (neuritis) • Numbness or weakness of the arms and legs (neuropathy), paralysis
Effetti mhux mixtieqa li seħħu rarament ħafna waqt provi kliniċi jew wara l- użu ġenerali tal- vaċċin jew wara l- użu ta ’ vaċċini separati tal- epatite A u B jinkludu: • Tnaqqis fil- plejtlits tad- demm, li jżid ir- riskju ta ’ fsada jew tbenġil (tromboċitopenja) • Ponot vjola jew ħomor kannella li jidhru mill- ġilda (purpura tat- tromboċitopenja) • Nefħa jew infezzjoni fil- moħħ (enkefalite) • Mard deġenerattiv tal- moħħ (enkefalopatija) • Infjammazzjoni tan- nervituri (newrite) • Nuqqas ta ’ sensazzjoni jew dgħjufija fid- dirgħajn u s- saqajn (newropatija), paraliżi • Aċċessjonijiet
44 • Fits or seizures • Swelling of the face, mouth or throat (angioneurotic oedema) • Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme), hives • Joint swelling, muscular weakness • Infection around the brain which may give severe headache with stiff neck and sensitivity to light (meningitis) • Inflammation of some blood vessels (vasculitis) • Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
44 • Nefħa tal- wiċċ, ħalq jew tal- gerżuma (edema angjonewrotika) • Ħotob vjola jew ħomor għal vjola fuq il- ġilda (lichen planus), raxx serja tal- ġilda (eritema multiforme), tip ta ’ raxx • Nefħa tal- ġogi, dgħjufija tal- muskoli • Infezzjoni madwar il- moħħ li tista ’ tikkawża uġigħ ta ’ ras kbir b’ ebusija ta ’ l- għonq u sensittività għad- dawl (meninġite) • Infjammazzjoni ta ’ xi vini w arterji (vaskulite) • Reazzjonijiet allergiċi serji (anafilassi, reazzjonijiet allergiċi simili għal attakk anafilattiku u li jixbħu serum sickness).
Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Sinjali ta ’ reazzjonijiet allergiċi serji jistgħu jkunu tipi ta ’ raxx li jistgħu jkunu b’ ħakk jew bil- blisters, nefħa ta ’ l- għajnejn u tal- wiċċ, diffikultà biex tieħu n- nifs u biex tibla, pressjoni li titbaxxa f’ salt u tintilef minn sensik.
Such reactions may occur before leaving the doctor’s surgery.
Reazzjonijiet bħal dawn jistgħu jseħħu qabel ma titlaq mill- klinika tat- tabib.
However, if you get any of these symptoms you should contact a doctor urgently. • Abnormal laboratory liver test results • Multiple sclerosis, swelling of the spinal cord (myelitis) • Drooping eyelid and sagging muscles on one side of the face (facial palsy) • A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome) • A disease of the nerves of the eye (optic neuritis)
Madankollu jekk ikollok xi wieħed minn dawn is- sintomi għandek tkellem tabib b’ urġenza. • Riżultati tat- testijiet tal- laboratorju tal- fwied abnormali • Sklerożi multipla, nefħa fin- nerv li jgħaddi minn ġos- sinsla tad- dahar (majelite) • Tebqet il- għajn nieżla l- isfel u muskoli rotob fuq naħa waħda tal- wiċċ (palsy tal- wiċċ) • Infjammazzjoni temporanja tan- nervituri li tikkawża uġigħ, dgħjufija u paraliżi fid- dirgħajn u s - saqajn u ħafna drabi li tkompli sejra fis- sider u fil- wiċċ (marda ta ’ Guillain- Barré) • Mard tan- nervituri ta ’ l- għajnejn (newrite ottika)
HOW TO STORE TWINRIX ADULT
KIF TAĦŻEN TWINRIX ADULT
Do not use Twinrix Adult after the expiry date which is stated on the carton.
Tużax Twinrix Adult wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Store in the original package in order to protect from light.
Żomm fil - kontenitur oriġinali sabiex tilqa mid- dawl.
What Twinrix Adult contains
X’ fih Twinrix Adult
3 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4
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
- The other ingredients in Twinrix Adult are: sodium chloride, water for injections.
- Is- sustanzi l- oħra fi Twinrix Adult huma: sodium chloride, ilma għall- injezzjonijiet
What Twinrix Adult looks like and contents of the pack
Id- Dehra ta ’ Twinrix Adult u l- kontenuti tal- pakkett:
45 Suspension for injection.
45 Suspensjoni għall- injezzjoni.
Twinrix Adult is a white, slightly milky liquid presented in a glass vial (1 ml).
Twinrix Adult huwa likwidu abjad qisu ħalib, preżentat ġo fjala tal- ħġieġ (1ml).
Twinrix Adult is available in packs of 1, 10, and 25.
Twinrix Adult jinsab f’ pakketti ta ’ 1, 10 jew 25.
Rue de l’Institut 89 B-1330 Rixensart Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu /.
---------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------------
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Waqt li jkun maħżun, depożitu fin u abjad u medda ċara bla kulur fil- wiċċ jistgħu jifformaw.
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 mħawwad sew sabiex tinkiseb suspensjoni bajda u ftit opaka u għandu jkun mifli sew għal xi partiċelli barranin jew xi tibdil fl- apparenza fiżika qabel ma jingħata.
In the event of either being observed, discard the vaccine.
F’ każ li wieħed minn dawn jiġi osservat, ma għandux jintuża.
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 mimlija għal- lest 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
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 w adoloxxenti minn 16 il- sena l- fuq 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.
These consist of nausea (feeling sick), fever and aches and pains.
Dawn jikkonsistu f’ nawżea (ma tkunx f’ sikktek), deni kif ukoll uġigħ ‘ l hawn u ‘ l hemm.
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 jirkupraw kompletament, għalkemm l- marda taf tkun qawwija biżżejjed li żżomm lin- nies ma jifilħux għal madwar xahar.
It causes the liver to become swollen (inflamed).
Tikkawża lill- fwied jintefaħ (infjammat).
48 Take special care with Twinrix Adult:
Oqgħod attent ħafna bi Twinrix Adult:
• if you have experienced any health problems after previous administration of a vaccine. • if you have a poor immune system due to illness or drug treatment. • if you have a bleeding problem or bruise easily.
48 • jekk int qatt kellek xi problemi relatati mas- saħħa wara xi tilqima. • jekk għandek immunita ’ baxxa minħabba xi mard jew xi kura medika • jekk għandek problemi biex jagħqad id- demm jew titbenġel malajr.
A poor response to the vaccine, possibly without achieving protection against hepatitis B, has also been observed in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Rispons dgħajjef għall- vaċċin li jista ’ ma jwassalx għal protezzjoni kontra l- epatite B, ġie osservat ukoll fl- anzjani, fl- irġiel iktar milli fin- nisa, f’ min ipejjep, f’ min għandu piż żejjed, u f’ nies b’ mard kroniku jew dawk fuq xi tipi ta ’ trattamenti mediċi.
Using other medicines or vaccines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Meta tuża mediċini jew vaċċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, jew jekk ħadt xi tilqim ieħor dan l- aħħar.
The first dose will be given on an elected date.
L- ewwel doża tiġi mogħtija fid- data magħżulha.
The remaining two doses will be given one month, and six months after the first dose.
Iż- żewġ dożi li jkun għad baqa jingħataw xahar, u sitt xhur wara l- ewwel doża.
• • •
• L- ewwel doża: fid- data magħżula • T- tieni doża: xahar wara • T- tielet doża:
Twinrix Adult can also be given as a total of three doses over 1 month.
Twinrix Adult tista wkoll tingħatha bħala total ta tlett dożi fi żmien xahar wieħed.
This schedule may be given to adults only needing a rapid protection (e.g. overseas travellers).
Din l- iskeda tista tingħata biss lill- adulti li għandhom bżonn ta ’ protezzjoni mingħajr dewmin (eż persuni li se jivjaġġaw barra l- pajjiż).
The first dose will be given on an elected date.
L- ewwel doża tingħatha fid- data magħżulha.
Fourth dose:
T- tieni doża T- tielet doża R- raba doża
As indicated in Section 2, a poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Rispons dgħajjef għall- vaċċin li jista ma jwassalx għal- protezzjoni kontra l- epatite B, huwa aktar komuni fl - anzjani, fl- irġiel iktar milli fin- nisa, f’ min ipejjep, f’ min għandu piż żejjed, u f’ nies b’ mard kroniku jew f’ dawk fuq xi tipi ta’ trattamenti mediċi.
Your doctor may advise you to have a blood test after you have completed the course of vaccinations to check if you
It- tabib tiegħek għandu mnejn jagħmillek xi eżami tad- demm wara li tlesti l- kors tat- tilqim biex jara jekk kellekx rispons adekwat.
49 have made a satisfactory response.
49 Kun żgur li tispiċċa il- programm kollu tat- tlett vaċċinazzjoniet.
If not, your doctor will advise you on the possible need to have extra doses.
Jekk le, int tista ma tkunx protett kontra dan il- mard.
The vaccine should not be given (deep) into the skin or intramuscularly into the buttock because protection may be less.
Il- vaċċin m’ għandux jingħata fil- ġilda (fil- fond) jew fil- muskolu tal- warrani għax il- protezzjoni tista tkun anqas.
The vaccine should never be given into a vein.
Il- vaċċin ma għandu qatt jingħata fil- vina.
Side effects occurred very rarely during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines include: • Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia) • Purple or red brown spots visible through the skin(thrombocytopenic purpura) • Swelling or infection of the brain (encephalitis) • Degenerative disease of the brain (encephalopathy) • Inflammation of nerves (neuritis) • Numbness or weakness of the arms and legs (neuropathy), paralysis
Effetti mhux mixtieqa li seħħu rarament ħafna waqt provi kliniċi jew wara l- użu ġenerali tal- vaċċin jew wara l- użu ta ’ vaċċini separate tal- epatite A u B jinkludu: • Tnaqqis fil- plejtlits tad- demm, li jżid ir- riskju ta ’ fsada jew tbenġil (tromboċitopenja) • Ponot vjola jew ħomor kannella li jidhru mill- ġilda (purpura tat- tromboċitopenja) • Nefħa jew infezzjoni fil- moħħ (enkefalite) • Mard deġenerattiv tal- moħħ (enkefalopatija) • Infjammazzjoni tan- nervituri (newrite) • Nuqqas ta ’ sensazzjoni jew dgħjufija fid- dirgħajn u s- saqajn (newropatija), paraliżi • Aċċessjonijiet • Nefħa tal- wiċċ, ħalq jew tal- gerżuma (edema angjonewrotika)
50 • Fits or seizures • Swelling of the face, mouth or throat (angioneurotic oedema) • Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme), hives • Joint swelling, muscular weakness • Infection around the brain which may give severe headache with stiff neck and sensitivity to light (meningitis) • Inflammation of some blood vessels (vasculitis) • Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
50 • Ħotob vjola jew ħomor għal vjola fuq il- ġilda (lichen planus), raxx serja tal- ġilda (eritema multiforme), tip ta ’ raxx • Nefħa tal- ġogi, dgħjufija tal- muskoli • Infezzjoni madwar il- moħħ li tista ’ tikkawża uġigħ ta ’ ras kbir b’ ebusija ta ’ l- għonq u sensittività għad- dawl (meninġite) • Infjammazzjoni ta ’ xi vini w arterji (vaskulite) • Reazzjonijiet allergiċi serji (anafilassi, reazzjonijiet allergiċi simili għal attakk anafilattiku u li jixbħu serum sickness).
Hepatitis A virus (inactivated)1,2 Hepatitis B surface antigen 3,4 1 Produced on human diploid (MRC-5) cells 2
Virus tal- epatite A (inattivat) 1, 2 Antiġen tas- superfiċje ta ’ l- epatite B 3, 4 1 Manifatturat fuq ċelluli umani tat- tip diploid (MRC- 5) 2
51 Suspension for injection in prefilled syringe.
51 Id- dehra ta ’ Twinrix Adult u l- kontenuti tal- pakkett:
Twinrix Adult is a white, slightly milky liquid presented in a glass prefilled syringe (1 ml).
Twinrix Adult huwa likwidu abjad qisu ħalib, preżentat ġo siringa tal- ħġieġ mimlija għal- lest (1ml).
Twinrix Adult is available in packs of 1, 10, and 25 with or without needles.
Twinrix Adult jinsab f’ pakketti ta ’ 1, 10 jew 25 bil- labar jew mingħajrhom.
Rue de l’Institut 89 B-1330 Rixensart Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Waqt li jkun maħżun, jistgħu jifforma depożitu fin u abjad u medda ċara bla kulur fil- wiċċ.
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 mħawwad sew sabiex tinkiseb suspensjoni bajda u ftit opaka u għandu jkun mifli sew għal xi pariċelli barranin jew xi tibdil fl- apparenza fiżika qabel ma jingħata.
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport ta ’’ Valutazzjoni Pubblika Ewropew (EPAR).
What is Twinrix Paediatric?
X’ inhu Twinrix Paediatric?
Twinrix Paediatric is a vaccine, which is available as a suspension for injection.
Twinrix Paediatric huwa vaċċin, li jiġi bħala sospensjoni għal injezzjoni.
It contains inactivated (killed) hepatitis A viruses and parts of the hepatitis B virus as active substances.
Bħala sustanzi attivi huwa fih vajrusis inattivati (maqtulin) ta ’ l- epatite A u partijiet mill- vajrus ta ’ l- epatite B.
It is available in a 0.5 ml vial and in a 0.5 ml prefilled syringe.
Huwa jiġi f’ kunjett ta ’ 0. 5 ml u f’ siringa mimlija għal- lest ta ’ 0. 5 ml.
What is Twinrix Paediatric used for?
Għal x’ hiex jintuża Twinrix Paediatric?
Twinrix Paediatric is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver).
Twinrix Paediatric jintuża biex jilqa ’ kontra infezzjoni b’ epatite A u b’ epatite B (mard li jaffettwa l - fwied).
It is used in infants, children and adolescents aged between one and 15 years who are not already immune to these two diseases and who are at risk of contracting both of them.
Huwa jintuża fi trabi, tfal u adolexxenti ta ’ bejn sena u ħmistax- il sena li mhumiex diġà immuni għal dawn iż- żewġ mardiet u li huma f’ riskju li jieħduhom it- tnejn li huma.
How is Twinrix Paediatric used?
Kif jintuża Twinrix Paediatric?
The recommended vaccination schedule for Twinrix Paediatric is three doses with a gap of one month between the first two doses and a gap of five months between the second and third.
L- iskeda ta ’ tilqim irrakkomandata għal Twinrix Paediatric hija ta ’ tliet dożi bi spazju ta ’ xahar bejn l - ewwel żewġ dożi u spazju ta ’ ħames xhur bejn it- tieni u t- tielet doża.
It should be given by injection into the muscle of the upper arm or the thigh.
Huwa għandu jingħata permezz ta ’ injezzjoni fil- muskolu tal- parti ta ’ fuq tad- driegħ jew fil- koxxa.
It is recommended that individuals who receive the first dose should complete all three doses of Twinrix Paediatric.
Huwa rrakkomandat li individwi li jirċievu l- ewwel doża għandhom ikomplu t- tliet dożi kollha ta ’ Twinrix Paediatric.
A booster dose of Twinrix Paediatric, or of a separate hepatitis A or B vaccine may be given, according to official recommendations.
Skond rakkomandazzjonijiet uffiċjali, tista ’ tingħata doża booster ta ’ Twinrix Paediatric, jew waħda separata ta ’ vaċċin ta ’ l- epatite A jew B.
How does Twinrix Paediatric work?
Kif jaħdem Twinrix Paediatric?
Twinrix Paediatric is a vaccine.
Twinrix Paediatric huwa vaċċin.
Twinrix Paediatric contains small amounts of inactivated hepatitis A viruses and the ‘ surface antigen ’ (proteins from the surface) of the hepatitis B virus.
Twinrix Paediatric fih ammonti żgħar ta ’ vajrusis ta ’ l- epatite A inattivati u l - ‘ antiġen tal- wiċċ ’ (proteini mill- wiċċ) tal- vajrus ta ’ l- epatite B.
In the future, the immune system will be able to make antibodies more quickly when it is exposed to the viruses.
Fil- futur, is- sistema immunitarja tkun tista ’ tagħmel antikorpi aktar malajr meta tkun esposta għall- vajrus.
The antibodies will help to protect against diseases caused by these viruses.
L- antikorpi se jgħinu biex jipproteġu kontra l- marda kkaġunata minn dawn il- virusijiet.
This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response.
Dan ifisser li l- vajrusijiet u l- antiġeni tal- wiċċ jitwaħħlu fuq komposti ta ’ l - aluminju, biex jistimolaw reazzjoni aħjar.
The surface antigens of the hepatitis B virus are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
L- antiġeni tal- wiċċ tal- vajrus ta ’ l- epatite B jsiru permezz ta ’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: huma jsiru minn ħmira li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini.
Twinrix Paediatric is identical to the vaccine Twinrix Adult, which has been available in the European Union (EU) since 1996.
Twinrix Paediatric huwa identiku għall- vaċċin Twinrix Adult, li ilu disponibbli fl- Unjoni Ewropea (UE) sa mill- 1996.
The only difference between the two vaccines is the amount of vaccine in each vial or syringe.
L- unika differenza bejn il- vaċċini huwa l- ammont ta ’ vaċċin f’ kull kunjett jew siringa.
The active substances in Twinrix Paediatric and Twinrix Adult have been available in the EU for a number of years in separate vaccines:
Is- sustanzi attivi fi Twinrix Paediatric u fi Twinrix Adult ilhom disponibbli fl- UE għal bosta snin f’ vaċċini separati:
Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.
Havrix Adult għall- protezzjoni kontra l- epatite A u Engerix- B għall - protezzjoni kontra l- epatite B.
How has Twinrix Paediatric been studied?
Kif ġie studjat Twinrix Paediatric?
Because Twinrix Paediatric and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Twinrix Paediatric.
Minħabba li Twinrix Paediatric u Twinrix Adult fihom sustanzi attivi identiċi, xi dejta wżata biex tappoġġja l- użu ta ’ Twinrix Adult intużat biex tappoġġja l- użu ta ’ Twinrix Paediatric.
Two studies were carried out in a total of 180 children and adolescents, all of whom received Twinrix Paediatric.
Saru żewġ studji fuq total ta ’ 180 tifel u tifla u adolexxenti, li kollha rċievew Twinrix Paediatric.
The main measure of effectiveness was the proportion of the children who had developed protective levels of antibodies to hepatitis A and hepatitis B.
Il - miżura ewlenija ta ’ l- effikaċja kienet il- proporzjon ta ’ tfal li żviluppaw livelli ta ’ protezzjoni ta ’ antikorpi għall- epatite A u l- epatite B.
Further studies looked at the persistence of antibody levels after vaccination.
Aktar studji ħarsu lejn il- persistenza ta ’ livelli ta ’ antikorpi wara t- tilqim.
What benefit has Twinrix Paediatric shown during the studies?
X’ benefiċċju wera Twinrix Paediatric waqt l- istudji?
The studies showed that Twinrix Paediatric produced an immune response that was at least as good as that seen during studies of Twinrix Adult.
L- istudji wrew li Twinrix Paediatric ipproduċa reazzjoni immunitarja li kienet ta ’ l- inqas tajba daqs dik murija waqt studji ta ’ Twinrix Adult.
All children had satisfactory antibody levels to hepatitis A by two months, and almost 100% had protective levels of antibodies to hepatitis B by six months (just before the third vaccine dose).
It- tfal kollha kellhom livelli ta ’ antikorpi sodisfaċenti għall - epatite A sa żmien xahrejn, u kważi 100% kellhom livelli ta ’ protezzjoni ta ’ antikorpi għall- epatite B sa żmien sitt xhur (eżatt qabel it- tielet doża tal- vaċċin).
Levels of antibodies to both hepatitis A and B increased after the third dose of the vaccine.
Livelli ta ’ antikorpi kemm għall- epatite A kif ukoll għall- epatite B żdiedu wara t- tielet doża tal- vaċċin.
The additional studies showed that the presence of antibodies was maintained for at least four years.
L- istudji addizjonali wrew li l- preżenza ta ’ antikorpi nżammet għal mill- inqas erba ’ snin.
What is the risk associated with Twinrix Paediatric?
X’ inhu r- riskju assoċjat ma ’ Twinrix Paediatric?
The most common side effect with Twinrix Paediatric (seen in more than 1 in 10 doses of the vaccine) is pain and redness at the injection site.
L- aktar effett sekondarju komuni ma ’ Twinrix Paediatric (deher f’ aktar minn doża 1 minn kull 10 tal - vaċċin) huwa uġigħ u ħmura fis- sit ta ’ l- injezzjoni.
For the full list of all side effects reported with Twinrix Paediatric, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati ma ’ Twinrix Paediatric, ara l- Fuljett ta ’ Tagħrif.
Twinrix Paediatric should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Twinrix Paediatric m’ għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għal kwalunkwe sustanza attiva tiegħu, kwalunkwe sustanza oħra jew għal neomycin (antibijotiku).
It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines.
M’ għandux jintuża wkoll f’ nies li kellhom reazzjoni allerġika wara li ngħataw il- vaċċini ta ’ l- epatite A jew ta ’ l- epatite B.
Twinrix Paediatric should be postponed in patients with a severe sudden fever.
Twinrix Paediatric għandu jiġi pospost f’ pazjenti b’ deni qawwi li jitla ’ f’ daqqa waħda.
Why has Twinrix Paediatric been approved?
Għaliex ġie approvat Twinrix Paediatric?
The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Paediatric’ s benefits are greater than its risks for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Twinrix Paediatric huma akbar mir- riskji tiegħu għal użu fuq trabi, tfal u adolexxenti mhux immuni li għandhom minn sena sa u inkluż 15- il sena u li huma f’ riskju kemm ta ’ infezzjoni b’ epatite A kif ukoll ta ’ infezzjoni b’ epatite B.
The Committee recommended that Twinrix Paediatric be given marketing authorisation.
Il- Kumitat irrakkomanda li Twinrix Paediatric jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Twinrix Paediatric:
Tagħrif ieħor dwar Twinrix Paediatric:
The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s. a. for Twinrix Paediatric on 10 February 1997.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Twinrix Paediatric valida fl - Unjoni Ewropea kollha lil GlaxoSmithKline Biologicals s. a. fl- 10 ta ’ Frar 1997.
The marketing authorisation was renewed on 10 February 2002 and on 10 February 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 10 ta ’ Frar 2002 u fl- 10 ta ’ Frar 2007.
The full EPAR for Twinrix Paediatric can be found here.
L- EPAR sħiħ għal Twinrix Paediatric jista ’ jinstab hawnhekk.
NAME OF MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI
Twinrix Paediatric, suspension for injection Hepatitis A (inactivated) and hepatitis B(rDNA) (HAB) vaccine (adsorbed).
Twinrix Paediatric, suspensjoni għall- injezzjoni Vaċċin (adsorbit) tal- epatite A (inattivat) u epatite B (rDNA) (HAB).
360 ELISA Units 10 micrograms
360 ELISA Units 10 mikrogrammi
Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4 Adsorbed on aluminium phosphate
0. 025 milligrammi A13+ Adsorbit fuq aluminium hydroxide idratat 3 Manifatturat fuq ċelluli tal- ħmira (Saccharomyces cerevisiae) b’ teknoloġija rikombinanti tad- DNA 4 0. 2 milligrammi A13+ Adsorbit fuq aluminium phosphate
Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Twinrix Paediatric huwa indikat għall- użu fit- trabi, tfal u adoloxxenti ta ’ eta` minn sena sa u jinkludi 15 il- sena li ma jkollhomx l- immunita ’ relevanti u li huma fir- riskju ta ’ infezzjoni mill- epatite A kif ukoll mill- epatite B.
The dose of 0.5 ml (360 ELISA Units HA/ 10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
Doża ta ’ 0. 5 ml (360 ELISA Units/ 10μg HbsAg) hija rakkomandata għal trabi, tfal u adoloxxenti ta ’ eta` minn sena sa u jinkludi 15 il- sena.
The standard primary course of vaccination with Twinrix Paediatric 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 Paediatric jikkonsisti fi tliet dożi, ta ’ l- ewwel somministrata fid- data mixtieqa, it- tieni, xahar wara u t- tielet sitt xhur wara l- ewwel doża.
- Booster dose.
- Doża ta ’ rinforz.
Long-term antibody persistence data following vaccination with Twinrix Paediatric are available up to 48 months after vaccination.
Hemm informazzjoni fuq il- persistenza tal- antikorp wara tilqima bi Twinrix Paediatric sa 48 xahar wara li tingħata.
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 medda ta ’ dawk wara t- tilqima bil- vaċċini
2 for booster vaccination can therefore be drawn from experience with the monovalent vaccines.
L- antikorpi jonqsu wkoll bl- istess kinetika.
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 ’ doża ta ’ rinforz tal- vaċċin tal- epatite B u dawn għandhom ikunu rispettati.
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.
Għal xi wħud mill- kategoriji ta ’ suġġetti jew pazjenti esposti għal HBV (eż. 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 insured 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 Paediatric can be given.
F’ sitwazzjonijiet fejn doża ta ’ rinforz kemm tal- epatite A u l- epatite B huwa meħtieġ, Twinrix Paediatric jista tingħata.
Alternatively, subjects primed with Twinrix Paediatric may be administered a booster dose of either of the monovalent vaccines.
Jew inkella, suġġetti mibdija bi Twinrix Paediatric jistgħu jingħataw doża ta ’ rinforz b ’ waħda mill- vaċċini individwali.
Twinrix Paediatric is for intramuscular injection, preferably in the deltoid region in adolescents and children or in the anterolateral thigh in infants.
Twinrix Paediatric jingħata b ’ injezzjoni ġol- muskoli, l- aħjar fil- muskolu deltoid fl- adoloxxenti u fit - tfal jew fil- parti anterolaterali tal- koxxa fit- trabi.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
F’ każijiet rari, il- vaċċin jista jingħata taħt il- ġilda f’ pazjenti b’ nuqqas ta ’ pjastrini jew fejn id- demm ma jkunx jagħqad sew.
Hypersensitivity to the active substances or to any of the excipients or neomycin.
Sensittività eċċessiva 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.
Sensittività eċċessiva wara tilqim li jkun ingħata qabel għal- epatite A u/ jew epatite B.
The administration of Twinrix Paediatric should be postponed in subjects suffering from acute severe febrile illness.
L- użu ta ’ Twinrix Paediatric għandu jiġi pospost f’ suġġetti li għandhom mard li jagħti deni akut u serju ħafna.
It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
Jista jkun li fil- ħin tat- tilqima is- suġġett ikun fil- perjodu ta ’ inkubazzjoni tal- marda epatite A jew B. Mhuwiex magħruf jekk Twinrix Paediatric iwaqqafx l- epatite A u B f’ dawn il- każijiet.
Twinrix Paediatric is not recommended for postexposure prophylaxis (e. g. needle stick injury).
Twinrix Paediatric mhux irrakkomandat għal prevenzjoni ta ’ wara l- esposiżżjoni għall- virus (eż. tniggist b’ labbra użata).
The vaccine has not been tested in patients with impaired immunity.
Il- vaċċin ma ġiex ippruvat fuq pazjenti b’ immunita ’ baxxa.
Such patients may require additional doses of vaccine; nevertheless immunocompromised patients may fail
F’ pazjenti fuq l- emodijaliżi jew pazjenti b ’ immunita ’ baxxa, livelli adekwati tal- antikorpi anti- HAV u anti- HBs jistgħu ma jintlaħqux wara l -
3 to demonstrate an adequate response.
3 ewwel kors primarju ta ’ tilqim u dawn il- pazjenti jista jkollhom bżonn li jingħatalhom dożi addizzjonali oħra ta ’ vaċċin; xorta waħda f’ pazjenti b ’ immunita ’ baxxa jista ma jkunx hemm l- effett meħtieġ.
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 kull injezzjoni vaċċinali, 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 għal ġol- ġilda jew is- somministrazzjoni għal ġol- muskolu gluteali tista tikkawża rispons suboptimali għall- vaċċin, dawn il- metodi għandhom jiġu evitati.
However, exceptionally Twinrix Paediatric can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Madanakollu Twinrix Paediatric jista jingħata taħt il- ġilda lil suġġetti bl- għadd ta ’ pjastrini baxx jew problemi fejn ma jagħqadx id- demm peress li jista jkun hemm xi telf ta ’ demm wara s- somministrazzjoni għal ġol - muskoli f’ dawn is- suġġetti.
(see section 4.2)
(ara sezzjoni 4. 2)
TWINRIX PAEDIATRIC SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVASCULARLY.
TWINRIX PAEDIATRIC MA GĦANDU QATT JINGĦATA FIL- VINA
As with any injection procedure, vasovagal syncope can infrequently occur following administration of Twinrix Paediatric to adolescents.
Bħal f’ kull proċedura ta ’ injezzjoni, jista ’ jkun hemm vasovagal syncope, b’ frekwenza baxxa, wara li Twinrix Paediatric jingħata lil adoloxxenti.
No data on concomitant administration of Twinrix Paediatric with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Għad ma hemmx tagħrif dwar is- somministrazzjoni ta ’ Twinrix Paediatric 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 titers.
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.
As the concomitant administration of Twinrix Paediatric and other vaccines has not specifically been studied it is advised that the vaccine should not be administered at the same time as other vaccines.
Is- somministrazzjoni ta ’ Twinrix Paediatric flimkien ma vaċċini oħra mhijiex studjata, u għalhekk dan il- vaċċin m’ għandux jiġi somministrat fl- istess ħin ma vaċċini oħra.
The effect of Twinrix Paediatrict 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 Paediatric 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.
Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Paediatric 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.
Waqt li mhux mistenni li l - antiġen tas- superfiċje ta ’ l- epatite B rekombinanti jkollu effetti avversi fuq it- tqala jew fuq il- fetu, hu rakkomandat li t- 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 Paediatric is excreted in human breast milk.
Mhux magħruf jekk Twinrix Paediatric jgħaddix għal ġol- ħalib tas- sider.