qanastek/EMEA-V3 huggingface dataset:
14 The combination of emtricitabine and tenofovir disoproxil fumarate was positive in the in vitro mouse lymphoma assay, with comparable results to those obtained for tenofovir disoproxil fumarate alone.
Il- kumbinazzjoni ta ’ emtricitabine u tenofovir disoproxil fumarate kienet pożittiva fl- analiżi taċ- ċelluli tal- limfoma tal- ġrieden in vitro, b’ riżultati komparabbli ma ’ dawk miksuba għal tenofovir disoproxil fumarate waħdu.
The combination of emtricitabine and tenofovir disoproxil fumarate was negative in the bacterial reverse mutation assay (Ames assay).
Il- kumbinazzjoni ta ’ emtricitabine u tenofovir disoproxil fumarate kienet negattiva fl- analiżi tal- bacterial reverse mutation (Ames assay).
A one month dog study using the combination of emtricitabine and tenofovir disoproxil fumarate, found no exacerbation of toxicological effects compared to the separate components.
Studju dwar il- klieb li dam xahar, bl- użu tal- kumbinazzjoni ta ’ emtricitabine u tenofovir disoproxil fumarate, ma sab l- ebda taħrix ta ’ effetti tossikoloġiċi meta mqabbla ma ’ komponenti separati.
Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572) Microcrystalline cellulose (E460) Pregelatinised starch (gluten free)
Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572) Microcrystalline cellulose (E460) Pregelatinised starch (gluten free)
Glycerol triacetate (E1518) Hypromellose (E464) Indigo carmine aluminium lake (E132) Lactose monohydrate Titanium dioxide (E171)
Glycerol triacetate (E1518) Hypromellose (E464) Indigo carmine aluminium lake (E132) Lactose monohydrate Titanium dioxide (E171)
HDPE bottle with a child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Flixkun HDPE b’ għatu li ma jinfetħax mit- tfal li fihom 30 pillola miksija b’ rita u ġel dessikant tas - silika.
The following pack sizes are available: outer cartons containing 1 x 30 film-coated tablet and 3 x 30 film-coated tablet bottles.
Id- daqsijiet tal- pakketti li ġejjin huma disponibbli: kartun ta ’ barra li fihom flixkun ta ’ 30 pillola miksija b’ rita u kartun ta ’ barra li fihom 3 fliexken ta ’ 30 pillola miksija b’ rita.
21 February 2005
21 ta ’ Frar 2005
Cork, Ireland
Cork, L- Irlanda
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq irid jinforma lill- Kummissjoni Ewropea dwar il- pjanijiet tal- kummerċ tal- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
BOTTLE AND CARTON LABELLING
IL- KITBA TA ’ FUQ IL- KAXXA U T- TIKKETTA TAL- FLIXKUN
Truvada 200 mg/ 245 mg film-coated tablets Emtricitabine/ tenofovir disoproxil
Truvada 200 mg/ 245 mg pilloli miksija b’ rita Emtricitabine/ tenofovir disoproxil
Contains lactose monohydrate, see leaflet for further information.
Fih lactose monohydrate, ara l- fuljett ta ’ tagħrif għal iktar informazzjoni.
30 film-coated tablets.
30 pillola miksija b’ rita.
3 x 30 film-coated tablets.
3 x 30 pillola miksija b’ rita.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA ’ JINTLAĦAQX U MA JIDHIRX MIT- TFAL
EU/ 1/ 04/ 305/ 001 30 film-coated tablets EU/ 1/ 04/ 305/ 002 3 x 30 film-coated tablets
EU/ 1/ 04/ 305/ 001 30 pillola miksija b’ rita EU/ 1/ 04/ 305/ 002 3 x 30 pillola miksija b’ rita
Truvada [outer packaging only]
Truvada [pakkett ta ’ barra biss]
What Truvada is and what it is used for 2.
X’ inhi Truvada u għalxiex tintuża 2.
Before you take Truvada 3.
Qabel ma tieħu Truvada 3.
How to take Truvada 4.
Kif għandek tieħu Truvada 4.
How to store Truvada 6.
Kif taħżen Truvada 6.
WHAT TRUVADA IS AND WHAT IT IS USED FOR
X’ INHI TRUVADA U GĦALXIEX TINTUŻA
Truvada is a treatment for Human Immunodeficiency Virus (HIV) infection in adults over 18 years of age.
Truvada hu trattament għal Virus ta ’ l- Immunodefiċjenza Umana (HIV) fl- adulti li għandhom iktar minn 18- il sena.
Truvada contains two active substances, emtricitabine and tenofovir disoproxil.
Truvada fiha żewġ sustanzi attivi, emtricitabine u tenofovir disoproxil.
Both of these active substances are antiretroviral medicines which are used to treat HIV infection.
Dawn iż- żewġ sustanzi attivi huma mediċini antiretrovirali li jintużaw biex jittrattaw l- infezzjoni ta ’ l- HIV.
Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor.
Emtricitabine hu impeditur tan- nucleoside reverse transcriptase u tenofovir hu impeditur tan- nucleotide reverse transcriptase.
However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.
Madankollu, it- tnejn huma ġeneralment magħrufin bħala NRTIs u jaħdmu billi jinterferixxu mal- ħidma normali ta ’ enzima (reverse transcriptase) li hi essenzjali biex il- virus jirriproduċi.
Truvada should always be used combined with other medicines to treat HIV infection.
Truvada għandha dejjem tintuża ma ’ mediċini oħrajn biex tittratta infezzjoni bl- HIV.
Truvada can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
Truvada tista ’ tingħata minflok emtricitabine u tenofovir disoproxil użati separatament fl- istess dożi.
While taking Truvada you may still develop infections or other illnesses associated with HIV infection.
Waqt li tkun qed tieħu Truvada inti xorta waħda tista ’ tiżviluppa infezzjonijiet u mard ieħor marbut ma ’ l- infezzjoni ta ’ l- HIV.
You can also pass on the virus to others, so it is important to take precautions to avoid infecting other people.
Tista ’ wkoll tgħaddi l - virus lill- oħrajn, u għalhekk hu important li tieħu prekawzjonijiet biex ma tinfettax nies oħrajn.
BEFORE YOU TAKE TRUVADA
QABEL MA TIEĦU TRUVADA
Do not take Truvada
Tieħux Truvada
• If you are allergic (hypersensitive) to emtricitabine, tenofovir, tenofovir disoproxil fumarate, or any of the other ingredients of Truvada listed at the end of this leaflet.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal emtricitabine, tenofovir, tenofovir disoproxil fumarate, jew sustanzi oħra ta ’ Truvada elenkati fl- aħħar ta ’ dan il- fuljett.
Take special care with Truvada
Oqgħod attent/ a ħafna bi Truvada
• Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
• Għid lit- tabib tiegħek jekk inti kellek mard fil- kliewi, jew jekk it- testijiet urew li hemm problemi fil- kliewi tiegħek.
Truvada may affect your kidneys.
Truvada tista ’ taffettwa l- kliewi tiegħek.
Before starting treatment, your doctor may order blood tests to assess kidney function and may advise you to take the tablets less often.
Qabel tibda t- trattament, it- tabib tiegħek jista ’ jordna testijiet tad- demm biex jevalwa l- funzjoni tal- kliewi u jista ’ jagħtik parir biex tieħu l- pilloli inqas ta ’ spiss.
24 Truvada is not usually taken with other medicines that can damage your kidneys (see Taking other medicines).
Jekk
If this is unavoidable, your doctor will monitor your kidney function once a week.
25 dan ma jkunx jista ’ jiġi evitat, it- tabib tiegħek ser jimmonitorja l- funzjoni tal- kliewi tiegħek darba f’ ġimgħa.
Truvada has not been studied in patients over 65 years of age.
Truvada ma ġietx studjata f’ pazjenti li għandhom iktar minn 65 sena.
If you are older than this and are prescribed Truvada, your doctor will monitor you carefully.
Jekk għandek iktar minn 65 sena u tingħata riċetta għal Truvada, it- tabib tiegħek ser jimmonitorjak b’ attenzjoni.
• Do not give Truvada to children and adolescents under 18 years of age.
• Tagħtix Truvada lit- tfal u adolexxenti taħt it- 18 il- sena.
• Talk to your doctor if you have a history of liver disease, including hepatitis.
• Kellem lit- tabib tiegħek jekk inti qabel kellek passat mediku ta ’ mard tal- fwied, li jinkludi l- epatite.
Both active substances in Truvada show some activity against hepatitis B virus although they are not approved for the treatment of hepatitis B infection.
Iż- żewġ sustanzi attivi fi Truvada juru xi attività kontra l- virus ta ’ l- epatite B għalkemm m’ humiex approvati għat- trattament ta ’ l- infezzjoni bl - epatite B.
If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests in order to carefully monitor liver function.
Jekk għandek passat mediku ta ’ mard tal- fwied jew infezzjoni kronika bl- epatite B, it - tabib tiegħek jista ’ jagħmillek testijiet tad- demm biex jimmonitorja b’ attenzjoni il- funzjoni tal - fwied tiegħek.
• Once you start taking Truvada, look out for possible signs of lactic acidosis.
• Ġaladarba tibda tieħu Truvada, oqgħod attent/ a għal sinjali possibbli ta ’ aċidożi lattika.
Medicines containing nucleoside analogues, including Truvada, can cause lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver.
Mediċini li fihom analogi tan- nukleosidi, li jinkludu Truvada, jistgħu jikkawżaw l- aċidożi lattika (ammont żejjed ta ’ aċidu lattiku fid- demm tiegħek), kif ukoll tkabbir tal- fwied.
Deep, rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of lactic acidosis.
Nifs qawwi u mgħaġġel, telqa, u sintomi mhux speċifiċi bħal tqalligħ, rimettar u uġigħ fl- addome jistgħu jkunu evidenza ta ’ żvilupp ta ’ aċidożi lattika.
This rare but serious side effect has occasionally been fatal.
Dan l- effett sekondarju rari iżda serju xi drabi wassal għall- mewt.
Lactic acidosis occurs more often in women, particularly if they are very overweight.
L- aċidożi lattika sseħħ iżjed spiss fin- nisa partikularment jekk ikunu ħoxnin ħafna.
While you are being treated with Truvada, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Waqt li tkun qed tieħu Truvada, it- tabib tiegħek ser jeżaminak mill- qrib għal xi sinjali li jindikaw li tkun qed tiżviluppa l- aċidożi lattika.
Other precautions
Prekawzjonijiet oħra
Combination antiretroviral therapies (including Truvada) may raise blood sugar, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see section 4, Possible side effects).
Terapiji antiretrovirali kombinati (li jinkludu Truvada) jistgħu jgħollu l- livell taz- zokkor fid- demm, ix - xaħmijiet fid- demm (iperlipimja), jikkawżaw tibdil fix- xaħam tal- ġisem, u reżistenza għall- insulina (ara sezzjoni 4, Effetti sekondarji li jista ’ jkollu).
If you are diabetic, overweight or have high cholesterol, talk to your doctor.
Jekk inti dijabetiku/ a, għandek piż żejjed jew kolesterol għoli, kellem lit- tabib tiegħek.
Look out for infections.
Oqgħod attent/ a għall- infezzjonijiet.
If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Truvada is started.
Jekk għandek infezzjoni avvazata ta ’ l- HIV (AIDS) u għandek infezzjoni, inti tista ’ tiżviluppa sintomi ta ’ infezzjoni u infjammazzjoni jew is- sintomi ta ’ infezzjoni eżistenti jistgħu imorru għall- agħar ġaladarba jinbeda t- trattament bi Truvada.
These symptoms may indicate that your body’ s improved immune system is fighting infection.
Dawn is- sintomi jistgħu jindikaw li s- sistema immuni mtejba ta ’ ġismek qed tiġġieled lill- infezzjoni.
Look out for signs of inflammation or infection soon after you start taking Truvada.
Oqgħod attent/ a għal sinjali ta ’ infjammazzjoni jew infezzjoni malli tibda tieħu Truvada.
If you notice signs of inflammation or infection, tell your doctor at once.
Jekk tinnota sinjali ta ’ infjammazzjoni jew infezzjoni, għid lit- tabib tiegħek minnufih.
Bone problems.
Problemi fl- għadam.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ osteonekrożi huma: ebusija u uġigħ fil- ġogi (speċjalment fl- għadam tal- ġenbejn, l - irkopptejn u l- ispallejn) u diffikultà fiċ- ċaqliq.
Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Problemi fl- għadam (li xi kultant jirriżultaw fi ksur) jistgħu jseħħu wkoll minħabba ħsara liċ- ċelluli tubuli tal- kliewi (ara sezzjoni 4, Effetti sekondarji li jista ’ jkollha).
25 Taking other medicines
26 Meta tieħu mediċini oħra
You should not take Truvada if you are already taking other medicines that contain emtricitabine, tenofovir disoproxil, lamivudine or zalcitabine.
M’ għandekx tieħu Truvada jekk diġà qed tieħu mediċini oħra li fihom emtricitabine, tenofovir disoproxil, lamivudine jew zalcitabine.
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
• It is especially important to tell your doctor if you are taking other medicines which may damage your kidneys.
• B’ mod speċjali hu importanti li tgħid lit- tabib tiegħek jekk qed tieħu mediċini oħra li jistgħu jagħmlu ħsara lill- kliewi tiegħek.
aminoglycosides (for bacterial infection) amphotericin B (for fungal infection) foscarnet (for viral infection) ganciclovir (for viral infection) pentamidine (for infections) vancomycin (for bacterial infection) interleukin-2 (to treat cancer) cidofovir (for viral infection)
aminoglycosides (għal infezzjoni batterjali) amphotericin B (għal infezzjoni fungali) foscarnet (għal infezzjoni virali) ganciclovir (għal infezzjoni virali) pentamidine (għall- infezzjonijiet) vancomycin (għal infezzjoni batterjali) interleukin- 2 (għat- trattament tal- kanċer) cidofovir (għal infezzjoni virali)
• Other medicines containing didanosine (for HIV infection):
• Mediċini oħra li fihom didanosine (għall- infezzjoni bl- HIV):
Taking Truvada with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Li tieħu Truvada ma ’ mediċini antivirali oħra li fihom didanosine jista ’ jgħolli l- livelli ta ’ didanosine fid- demm tiegħek u jista ’ jnaqqas l- għadd taċ- ċelluli CD4 tiegħek.
Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil fumarate and didanosine were taken together.
F’ każijiet rari, infjammazzjoni tal- frixa u aċidożi lattika (ammont żejjed ta ’ aċidu lattiku fid- demm), li xi kultant twassal għall- mewt, kienu rrappurtati meta mediċini li fihom tenofovir disoproxil fumarate u didanosine, ittieħdu flimkien.
Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.
It- tabib tiegħek ikollu jikkunsidra attentament jekk jagħtikx trattament ta ’ tenofovir u didanosine.
Do not stop your treatment without contacting your doctor.
Twaqqafx it- trattament tiegħek mingħajr ma tikkuntattja lit- tabib tiegħek.
Taking Truvada with food and drink
Meta tieħu Truvada ma ’ l- ikel u max- xorb
• Truvada should be taken with food (for example, a meal or a snack).
• Truvada għandha tittieħed ma ’ l- ikel (per eżempju ma ’ ikla jew ma ’ ikla ħafifa).
• You must not take Truvada during pregnancy unless specifically discussed with your doctor.
• M’ għandekx tieħu Truvada matul it- tqala ħlief jekk tkun iddiskutejt dan mat- tabib tiegħek.
There are no clinical data on the use of Truvada in pregnant women and it is not usually used unless absolutely necessary.
M’ hemmx informazzjoni klinika dwar l- użu ta ’ Truvada f’ nisa tqal u din normalment ma tintużax jekk mhux assolutament meħtieġ.
• If you are a woman who could get pregnant during treatment with Truvada, you must use an effective method of contraception to avoid becoming pregnant.
• Jekk inti mara li tista ’ toħroġ tqila matul it- trattament bi Truvada, għandek tuża metodu effettiv ta ’ kontraċezzjoni sabiex tevita li toħroġ tqila.
• If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of antiretroviral therapy to you and your child.
• Jekk toħroġ tqila jew qed tippjana biex toħroġ tqila, staqsi lit- tabib tiegħek dwar il- benefiċċji u r- riskji potenzjali tat- terapija antiretrovirali għalik u għat- tarbija tiegħek.
If you have taken Truvada during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Jekk ħadt Truvada waqt it- tqala, it- tabib jista ’ jagħmillek testijiet regolari tad- demm u testijiet dijanjostiċi oħra biex jimmonitorja l- iżvilupp tat- tarbija tiegħek.
• Do not breast-feed during treatment with Truvada.
• M’ għandekx tredda ’ matul it- trattament bi Truvada.
It is not yet known whether the active substances in this medicine pass into human breast milk.
Għadu mhux magħruf jekk is- sustanzi attivi f’ din il- mediċina jgħaddux ġol- ħalib tas- sider uman.
26 • If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.
27 • Jekk inti mara li għandek l- HIV hu rakkomandat li ma treddax, biex tevita li tgħaddi l- virus lit - tarbija mill- ħalib tas- sider.
Truvada can cause dizziness.
Truvada tista ’ tikkawża sturdament.
If you feel dizzy while taking Truvada, do not drive and do not use any tools or machines.
Jekk tħossok stordut/ a meta tieħu Truvada, m’ għandekx issuq jew tagħmel użu minn għodda jew tħaddem magni.
Important information about some of the ingredients of Truvada
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Truvada
Tell your doctor if you are lactose-intolerant or intolerant to other sugars.
Staqsi lit- tabib tiegħek jekk għandek intolleranza għal lactose jew intolleranza għal ċerti tipi ta ’ zokkor.
If you know you are lactose-intolerant, or if you have been told that you have an intolerance to any other sugars, talk to your doctor before taking this medicine.
Jekk taf li għandek intolleranza għal lactose, jew jekk it - tabib qallek li għandek intolleranza għal ċerti tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE TRUVADA
KIF GĦANDEK TIEĦU TRUVADA
• Always take Truvada exactly as your doctor has told you.
• Dejjem għandek tieħu Truvada skond il- parir tat- tabib.
• Adults: one tablet each day with food (for example, a meal or a snack). • Not for children and adolescents
• Adulti: pillola waħda kuljum ma ’ l- ikel (per eżempju, ikla jew ikla ħafifa). • Mhux għat- tfal u adolexxenti
If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet.
Jekk ikollok xi diffikultà biex tibla ’, tista ’ tuża t- tarf ta ’ kuċċarina biex tfarrak il- pillola.
Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice, and drink immediately.
Imbagħad ħallat it- trab f’ madwar 100 ml (nofs tazza) ilma, meraq tal- larinġ jew meraq ta ’ l- għeneb, u ixrob immedjatament.
This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Dan biex taċċerta ruħek li l- mediċina tkun effettiva b’ mod sħiħ, u biex tnaqqas ir- riskju li tiżviluppa reżistenza għat- trattament.
• If you have problems with your kidneys, your doctor may advise you to take Truvada less frequently.
• Jekk għandek problemi bil- kliewi, it- tabib tiegħek jista ’ jagħtik parir biex tieħu Truvada inqas ta ’ sikwit.
• If your doctor decides to stop one of the components of Truvada or change the dose of Truvada, you may be given emtricitabine and/or tenofovir separately instead of the combined medicine or other medicines for the treatment of HIV infection.
• Jekk it- tabib tiegħek jiddeċiedi li jwaqqaf wieħed mill- komponenti ta ’ Truvada jew li jibdel id- doża ta ’ Truvada, inti tista ’ tingħata emtricitabine u/ jew tenofovir separatament minflok il - mediċina kombinata jew mediċini oħra għat- trattament ta ’ infezzjoni bl- HIV.
• Your doctor will prescribe Truvada with other antiretroviral medicines.
• It- tabib tiegħek ser jagħtik riċetta ta ’ Truvada flimkien ma ’ mediċini antiretrovirali oħra.
If you take more Truvada than you should
Jekk tieħu Truvada aktar milli suppost
If you accidentally take too many Truvada tablets, contact your doctor or nearest emergency department for advice.
Jekk aċċidentalment tieħu pilloli żejda ta ’ Truvada, ikkuntattja lit- tabib tiegħek jew l- eqreb dipartiment ta ’ l- emerġenza għal parir.
Keep the tablet bottle with you so that you can easily describe what you have taken.
Żomm il- flixkun tal- pilloli miegħek ħalli tkun tista ’ faċilment tiddeskrivi dak li tkun ħadt.
If you forget to take Truvada
Jekk tinsa tieħu Truvada
It is important not to miss a dose of Truvada.
Huwa importanti li ma tinsa tieħu ebda doża ta ’ Truvada.
If you do miss a dose of Truvada, take it as soon as you can, and then take your next dose at its regular time.
Jekk tinsa tieħu doża ta ’ Truvada, ħudha malli tkun tista ’, imbagħad ħu d- doża li jmiss fil- ħin regolari tagħha.
27 If it is almost time for your next dose anyway, forget about the missed dose.
28 Jekk ikun kważi wasal il- ħin għad- doża li jmiss, tiħux id- doża li tkun qbiżt.
If you throw up less than 1 hour after taking Truvada, take another tablet.
Jekk tirremetti inqas minn siegħa wara li tkun ħadt Truvada, ħu pillola oħra.
You do not need to take another tablet if you were sick more than 1 hour after taking Truvada.
M’ hemmx bżonn li tieħu pillola oħra jekk tirremetti iktar minn siegħa wara li tkun ħadt Truvada.
If you stop taking Truvada
Jekk tieqaf tieħu Truvada
• Stopping treatment with Truvada may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
• It- twaqqif tat- trattament bi Truvada jista jwassal għal tnaqqis fl- effett tat- terapija ta ’ kontra l - HIV rakkomandata mit- tabib tiegħek.
Speak with your doctor before you stop taking Truvada for any reason, particularly if you are experiencing any side effects or you have another illness.
Kellem lit- tabib tiegħek qabel ma tieqaf tieħu Tuvada għal kwalunkwe raġuni, partikularment jekk tkun qed iġarrab xi effetti sekondarji jew jekk ikollok xi marda oħra.
Contact your doctor before you restart taking Truvada tablets.
Ikkuntattja lit- tabib tiegħek qabel ma terġa ’ tibda tieħu l- pilloli Truvada.
• If you have HIV infection and hepatitis B, it is especially important not to stop your Truvada treatment without talking to your doctor first.
• Jekk għandek infezzjoni ta ’ l- HIV u epatite B, hu partikularment importanti li ma twaqqafx it- trattament tiegħek bi Truvada mingħajr ma tkellem lit- tabib tiegħek qabel.
Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Truvada.
Xi pazjenti kellhom testijiet tad- demm jew sintomi li indikaw li l- epatite tagħhom marret għall- agħar wara li waqfu jieħdu Truvada.
In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis.
F’ xi pazjenti b’ mard avvanzat tal- fwied jew ċirrożi, it- twaqqif tat - trattament mhuwiex rakkomandat, għax dan jista ’ jwassal li l- epatite tiegħek tmur għall- agħar.
Like all medicines, Truvada can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Truvada jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (These can affect at least 10 in every 100 patients treated)
Effetti sekondarji komuni ħafna (Dawn jistgħu jaffettwaw mill- inqas 10 minn kull 100 pazjent li jkunu ttrattati)
• dizziness, headache, diarrhoea, feeling sick (nausea), being sick (vomiting)
• sturdament, uġigħ ta ’ ras, dijarea, tħossok imdardar (tqalligħ), tibda tirremetti (rimettar)
• decreases in phosphate in the blood
• tnaqqis fil- phosphate fid- demm
Common side effects (These can affect 1 to 10 in every 100 patients treated)
Effetti sekondarji komuni (Dawn jistgħu jaffettwaw minn 1 sa 10 minn kull 100 pazjent li jkunu ttrattati)
• pain, stomach pain
• uġigħ, uġigħ fl- addome (żaqq)
• difficulty sleeping, abnormal dreams
• diffikultà biex torqod, ħolm anormali
• problems with digestion resulting in discomfort after meals, flatulence
• problemi bid- diġestjoni li jwasslu għal skonfort wara l- ikel, gass fl- istonku
28 • other allergic reactions, such as wheezing, swelling or feeling light-headed
29 • reazzjonijiet allerġiċi oħrajn, bħal tħarħir, nefħa jew ikollok il- mejt
• feeling weak
• tħossok dgħajjef
• increased triglycerides (fatty acids), bile or sugar in the blood
• żieda ta ’ triglycerides (aċidi tax- xaħam), bile jew zokkor fid- demm
Uncommon side effects (These can affect at least 1 in every 1,000 patients treated, but less than 1 in every 100 patients treated)
Effetti sekondarji mhux komuni (Dawn jistgħu jaffettwaw mill- inqas 1 minn kull 1, 000 pazjent li jkunu ttrattati, iżda inqas minn 1 minn kull 100 pazjent li jkunu ttrattati)
Rare side effects (These can affect at least 1 in every 10,000 patients treated, but less than 1 in every 1,000 patients treated)
Effetti sekondarji rari (Dawn jistgħu jaffettwaw mill- inqas 1 minn kull 10, 000 pazjent li jkunu ttrattati, iżda inqas minn 1 minn kull 1, 000 pazjent li jkunu ttrattati)
• increased creatinine in your blood
• żieda fil- krejatinina fid- demm tiegħek
• lactic acidosis (excess lactic acid in the blood, a serious side effect that can be fatal).
• aċidożi lattika (ammont żejjed ta ’ aċidu lattiku fid- demm, effett sekondarju serju li jista ’ jkun fatali).
The following side effects may be signs of lactic acidosis:
Dawn l- effetti sekondarji jistgħu jkunu sinjali ta ’ aċidożi lattika:
deep rapid breathing drowsiness feeling sick (nausea), being sick (vomiting) and stomach pain
nifs qawwi u mgħaġġel telqa tħossok imdardar (tqalligħ), tibda tirremetti (rimettar) u uġigħ fl- addome
think you may have lactic acidosis, contact your doctor immediately.
Jekk taħseb li għandek l- aċidożi lattika, ikkuntattja lit- tabib tiegħek minnufih.
• pain in the abdomen (tummy) caused by inflammation of the pancreas
• uġigħ fl- addome (żaqq) ikkawżat minn infjammazzjoni tal- frixa
• changes to your urine and back pain caused by kidney problems, including kidney failure
• tibdil fl- awrina tiegħek u uġigħ fid- dahar ikkawżat minn problemi fil- kliewi, li jinkludu kollass tal- kliewi
Very rare side effects (These can affect less than 1 in every 10,000 patients treated)
Effetti sekondarji rari ħafna (Dawn jistgħu jaffettwaw inqas minn 1 minn kull 10, 000 pazjent li jkunu ttrattati)
• shortness of breath
• qtugħ ta ’ nifs
• yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver
• ġilda jew għajnejn sofor, ħakk, jew uġigħ fl- addome (żaqq), ikkawżati minn infjammazzjoni tal - fwied
• damage to kidney tubule cells
• ħsara liċ- ċelluli tubuli tal- kliewi
You may also experience breakdown of muscle, muscle pain or weakness, softening of the bones (with bone pain and sometimes resulting in fractures), fatty liver, inflammation of the kidney, passing a lot of urine and feeling thirsty.
Jista ’ jkollok ukoll kollass tal- muskoli, uġigħ jew dgħjufija fil- muskoli, irtubija ta ’ l- għadam (b’ uġigħ fl- għadam u li xi kultant jirriżulta fi ksur), fwied li jkun fih ix- xaħam, infjammazzjoni tal- kliewi,
Tests may also show decreases in potassium in the blood.
It- testijiet jistgħu juru wkoll tnaqqis fil- potassium fid - demm.
29 The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Il- kollass tal- muskoli, l- irtubija ta ’ l- għadam (b’ uġigħ fl- għadam u li xi kultant tirriżulta fi ksur), uġigħ fil- muskoli, dgħjufija fil- muskoli u tnaqqis fil- potassium jew phosphate fid- demm jistgħu jseħħu minħabba ħsara liċ- ċelluli tubuli tal- kliewi.
Children who were administered emtricitabine, one of the components of Truvada, also experienced anaemia (low red blood cell count), commonly and changes in skin colour including darkening of the skin in patches, very commonly.
It- tfal li ngħataw emtricitabine, wieħed mill- komponenti ta ’ Truvada kellhom ukoll anemija (għadd baxx ta ’ ċelluli tad- demm ħomor) b’ mod komuni, u tibdil fil- kulur tal- ġilda li kien jinkludi l - iskurament tal- ġilda fi dbabar b’ mod komuni ħafna.
If the production of red blood cells is reduced, a child may have symptoms of tiredness or breathlessness.
Jekk il- produzzjoni ta ’ ċelluli tad- demm ħomor titnaqqas, t- tfal jista ’ jkollhom sintomi ta ’ għeja jew qtugħ ta ’ nifs.
Combination antiretroviral therapy (such as Truvada) may change your body shape, by changing the way body fat is distributed.
It- terapija antiretrovirali kombinata (bħal Truvada) tista ’ twassal għal bidliet fil- forma ta ’ ġismek dovuti għall- bidliet fit- tqassim tax- xaħam.
You may lose fat from your legs, arms and face; gain fat around the abdomen (tummy) and internal organs; get larger breasts or fatty lumps on the back of the neck (‘buffalo hump’).
Tista ’ titlef xaħam mir- riġlejn, mid- dirgħajn u mill- wiċċ; tista ’ żżid ix- xaħam fl- addome (żaqq) u f’ organi interni oħra; tkabbir fis- sider u għoqod ta ’ xaħam fuq wara ta ’ l- għonq (’ ħotba tal- buflu ’).
Combination antiretroviral therapy may also cause hyperlipaemia (increased fats in the blood) and resistance to insulin.
It- terapija antiretrovirali kombinata tista ’ wkoll tikkawża l- iperlipimja (żieda tax- xaħmijiet fid- demm) u reżistenza għall- insulina.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE TRUVADA
KIF TAĦŻEN TRUVADA
Do not use Truvada after the expiry date which is stated on the bottle and carton after {EXP}.
Tużax Truvada wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kaxxa {JIS}.
What Truvada contains
X’ fih Truvada
• The active substances are emtricitabine and tenofovir disoproxil.
• Is- sustanzi attivi huma emtricitabine u tenofovir disoproxil.
Each Truvada film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate, or 136 mg of tenofovir).
Kull pillola miksija b’ rita ta ’ Truvada fiha 200 mg ta ’ emtricitabine u 245 mg ta ’ tenofovir disoproxil (ekwivalenti għal 300 mg ta ’ tenofovir disoproxil fumarate, jew 136 mg ta ’ tenofovir).
• The other ingredients are croscarmellose sodium, glycerol triacetate (E1518), hypromellose (E464), indigo carmine aluminium lake (E132), lactose monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), pregelatinised starch (gluten free) and titanium dioxide (E171).
• Is- sustanzi l- oħra huma croscarmellose sodium, glycerol triacetate (E1518), hypromellose (E464), indigo carmine aluminium lake (E132), lactose monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), pregelatinised starch (gluten free) u titanium dioxide (E171).
What Truvada looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett
Truvada film-coated tablets are blue, capsule-shaped tablets, engraved on one side with the word “GILEAD” and on the other side with the number “701”.
Il- pilloli miksija b’ rita ta ’ Truvada huma blu, f’ forma ta ’ kapsula, b ’ “ GILEAD ” imnaqqxa fuq naħa waħda u n- numru “ 701 ” fuq in- naħa l- oħra.
Truvada comes in bottles of 30 tablets.
Truvada tiġi fi fliexken ta ’ 30 pillola.
The following pack sizes are available: outer cartons containing 1 x 30 film-coated tablet and 3 x 30 film-coated tablet bottles.
31 Id- daqsijiet tal- pakketti li ġejjin huma disponibbli: kartun ta ’ barra li fihom flixkun ta ’ 30 pillola miksija b’ rita u kartun ta ’ barra li fihom 3 fliexken ta ’ 30 pillola miksija b’ rita.
30 Marketing Authorisation Holder and Manufacturer:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Gilead Sciences Limited IDA Business & Technology Park Carrigtohill County Cork Ireland
Gilead Sciences Limited IDA Business & Technology Park Carrigtohill County Cork L- Irlanda
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq:
Ελλάδα Gilead Sciences Ελλάς Μ.ΕΠΕ.
32 Polska Ελλάδα Gilead Sciences International Ltd Gilead Sciences Ελλάς Μ. ΕΠΕ.
Τηλ: + 30 210 8930 100
Tel: + 44 (0) 20 7136 8820 Τηλ: + 30 210 8930 100
Tel: + 34 91 378 98 30
Portugal España Gilead Sciences, Lda.
What is Twinrix Adult?
X’ inhu Twinrix Adult?
Twinrix Adult is a vaccine, which is available as a suspension for injection.
Twinrix Adult 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 virusis inattivati (maqtulin) ta ’ l- epatite A u partijiet mill- virus ta ’ l- epatite B.
It is available in a 1 ml vial and in a 1 ml prefilled syringe.
Huwa jinsab f’ kunjett ta ’ 1 ml u f’ siringa mimlija għal- lest ta ’ 1 ml.
What is Twinrix Adult used for?
Għal x’ hiex jintuża Twinrix Adult?
Twinrix Adult is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver).
Twinrix Adult jintuża biex jipproteġi kontra infezzjoni b’ epatite A u b’ epatite B (mard li jaffettwa l - fwied).
It is used in adults and adolescents from 16 years of age who are not already immune to these two diseases and who are at risk of contracting both of them.
Huwa jintuża f’ adulti u f’ adolexxenti ta ’ etajiet minn 16- 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 Adult used?
Kif jintuża Twinrix Adult?
The recommended vaccination schedule for Twinrix Adult 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 Adult hija tliet dożi, bi spazju ta ’ xahar bejn l- ewwel żewġ dożi u spazju ta ’ ħames xhur bejn it- tieni u t- tielet.
The vaccine is injected into the muscle of the upper arm.
Il- vaċċin huwa injettat fil- muskolu tal- parti ta ’ fuq tad- driegħ jew fil- koxxa.
In exceptional cases, the three injections can be given over three weeks for adults needing rapid protection before travelling.
F’ każijiet eċċezzjonali, it- tlett injezzjonijiet jistgħu jingħataw fuq tliet ġimgħat għal adulti li jeħtieġu protezzjoni ta ’ malajr qabel jivjaġġaw.
In these cases, a fourth injection is recommended 12 months after the first dose.
F’ dawn il- każijiet, ir- raba ’ injezzjoni hija rrakkomandata 12- il xahar wara l- ewwel doża.
It is recommended that individuals who receive the first dose should complete all doses of Twinrix Adult.
Huwa rrakkomandat li individwi li jirċievu l- ewwel doża għandhom ikomplu t- tliet dożi kollha ta ’ Twinrix Adult.
A booster dose of Twinrix Adult, 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 Adult, jew waħda separata ta ’ vaċċin ta ’ l- epatite A jew B.
How does Twinrix Adult work?
Kif jaħdem Twinrix Adult?
Twinrix Adult is a vaccine.
Twinrix Adult huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tiddefendi lilha nnifisha kontra marda.
Twinrix Adult contains small amounts of inactivated hepatitis A viruses and the ‘ surface antigen ’ (proteins from the surface) of the hepatitis B virus.
Twinrix Adult fih ammonti żgħar ta ’ virusis ta ’ l- epatite A inattivati u l - ‘ antiġen tal- wiċċ ’ (proteini mill- wiċċ) tal- virus ta ’ l- epatite B.
When a person is given the vaccine, the immune system recognises the viruses and surface antigens as ‘ foreign’ and makes antibodies against them.
Meta persuna tingħata l- vaċċin, is- sistema immunitarja tagħraf l- antiġeni tal- wiċċ bħala ‘ barranin ’ u tagħmel antikorpi kontrihom.
If exposed to the viruses in the future, the immune system will be able to make antibodies more quickly.
Fil- futur, is- sistema immunitarja tkun tista ’ tagħmel antikorpi aktar malajr meta tkun esposta għall- virusis.
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- virusis.
This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response.
Dan ifisser li l- virusis 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 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- antiġeni tal- wiċċ tal- virus ta ’ l- epatite B jsiru permezz ta ’ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. 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.
Reproduction is authorised provided the source is acknowledged. metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: huma jsiru minn ħmira li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini.
The active substances in Twinrix Adult have been available in the European Union (EU) for a number of years in separate vaccines:
Is- sustanzi attivi 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 għal protezzjoni kontra l- epatite A u Engerix- B għal protezzjoni kontra l- epatite B.
How has Twinrix Adult been studied?
Kif ġie studjat Twinrix Adult?
Twinrix Adult has been studied in three main studies involving 843 healthy people aged between 18 and 60 years, most of whom were under 40 years of age.
Twinrix Adult ġie studjat fi tliet studji ewlenin li involvew 843 nies f’ saħħithom ta ’ etajiet bejn 18 u 60 sena, il- parti l- kbira minnhom kienu taħt l- età ta ’ 40 sena.
Each person received Twinrix Adult doses at months 0, 1 and 6.
Kull persuna rċiviet dożi ta ’ Twinrix Adult f’ xhur 0, 1 u 6.
The main measure of effectiveness was the proportion of the people who had developed antibodies against hepatitis A and B.
Il- miżura ewlenija ta ’ l- effettività kien il- proporzjon tan- nies li żviluppaw livelli ta ’ protezzjoni ta ’ antikorpi għall- epatite A u l- epatite B.
Further studies looked at the persistence of antibodies after vaccination in adults and adolescents, and at the schedule for vaccinating adults over three weeks when rapid protection is required.
Aktar studji ħarsu lejn il- persistenza ta ’ livelli ta ’ antikorpi wara t- tilqim f’ adulti u adolexxenti, u lejn l- iskeda ta ’ tilqim ta ’ l- adulti fuq tliet ġimgħat meta tkun meħtieġa protezzjoni ta ’ malajr.
What benefit has Twinrix Adult shown during the studies?
X’ benefiċċju wera Twinrix Adult waqt l- istudji?
The studies showed that for hepatitis A, antibodies were detected in 94% of adults after the first dose, 99.5% after the second dose and 100% after the third dose.
L- istudji wrew li għall- epatite A, antikorpi kienu osservati f’ 94% ta ’ adulti wara l- ewwel doża, 99. 5% wara t- tieni doża u 100% wara t- tielet.
For hepatitis B, antibodies were detected in 71% of adults after the first dose, 97% after the second dose and 99.7% after the third dose.
Għall- epatite B, antikorpi kienu osservati f’ 71% wara l- ewwel doża, 97% wara t- tieni doża u 99. 7% wara t- tielet doża.
The additional studies showed that the presence of antibodies was maintained for up to five years.
L- istudji addizjonali wrew li l- preżenza ta ’ antikorpi nżammet għal mill- inqas ħames snin.
The three-week vaccination schedule also led to the production of antibodies in around 83% of patients, rising to around 89% after the booster dose at month 12.
L- iskeda ta ’ tilqim ta ’ tliet ġimgħat wasslet ukoll għall- produzzjoni ta ’ antikorpi f’ madwar 83% ta ’ pazjenti, li telgħu għal madwar 89% wara d- doża booster f’ xahar 12.
What is the risk associated with Twinrix Adult?
X’ inhu r- riskju assoċjat ma ’ Twinrix Adult?
The most common side effects with Twinrix Adult (seen in more than 1 in 10 doses of the vaccine) are headache, pain and redness at the injection site, and fatigue (tiredness).
L- aktar effetti sekondarji komuni bi Twinrix Adult (dehru f’ aktar minn doża 1 minn kull 10 tal- vaċċin) huma uġigħ ta ’ ras, uġigħ u ħmura fis- sit ta ’ l- injezzjoni u għeja kbira.
For the full list of all side effects reported with Twinrix Adult, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati bi Twinrix Adult, ara l- Fuljett ta ’ Tagħrif.
Twinrix Adult 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 Adult m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal kwalunkwe sustanza attiva, għal 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 ukoll f’ nies li kellhom reazzjoni allerġika wara li ngħataw il- vaċċini ta ’ l- epatite A jew ta ’ l- epatite B.
Twinrix Adult should be postponed in patients with a severe sudden fever.
Twinrix Adult għandu jiġi pposponut f’ pazjenti b’ deni qawwi li jitla ’ f’ daqqa waħda.
It should never be injected into a vein.
Huwa qatt m’ għandu jiġi injettat ġol- vina.
Why has Twinrix Adult been approved?
Għalfejn ġiex approvat Twinrix Adult?
The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Adult’ s benefits are greater than its risks for use in non-immune adults and adolescents of 16 years of age and above 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 Adult huma akbar mir- riskji tiegħu għal użu f’ adulti u f’ adolexxenti minn 16- il sena ’ l fuq mhux immuni li huma f’ riskju kemm ta ’ infezzjoni bl- epatite A kif ukoll bl- epatite B.
The Committee recommended that Twinrix Adult be given marketing authorisation.
Il- Kumitat irrakkomanda li Twinrix Adult jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Twinrix Adult:
Tagħrif ieħor dwar Twinrix Adult:
The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s. a. for Twinrix Adult on 20 September 1996.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Twinrix Adult valida fl - Unjoni Ewropea kollha lil GlaxoSmithKline Biologicals s. a. fl- 20 ta ’ Settembru 1996.
The marketing authorisation was renewed on 20 September 2001 and on 20 September 2006.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 20 ta ’ Settembru 2001 u fl- 20 ta ’ Settembru 2006.
The full EPAR for Twinrix Adult can be found here.
L- EPAR sħiħ għal Twinrix Adult huwa disponibbli minn hawnhekk.
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) contains:
doża waħda (1 millilitru) fiha:
Hepatitis A virus (inactivated)1,2 Hepatitis B surface antigen3,4 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
720 ELISA Units 20 micrograms
720 ELISA Unit 20 mikrogrammi
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
Turbid white suspension.
Suspensjoni għall- injezzjoni 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 minn 16 il- sena il- fuq li ma jkollhomx l - immunita ’ relevanti u li huma fir- riskju ta ’ infezzjoni mill- epatite A kif ukoll mill- epatite B.
- Dosage
- Doża
A dose of 1.0 ml is recommended for adults and adolescents 16 years of age and above.
Doża ta’ 1. 0 millilitru hija rakkomandata għal Adulti u adoloxxenti ta ’ l- fuq minn 16 il- sena.
- Primary vaccination schedule
- Skeda ta ’ tilqim primarju
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 tliet dożi, ta ’ l- ewwel amministrat 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’ każijiet 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, tista tingħata skeda ta’ tliet injezzjonijiet għal ġol- muskoli fi żmien 0, 7 u 21 ġurnata.
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 rakkommandata li tingħata tnax- il- xahar wara it- teħid ta ’ l- ewwel doża.
The recommended schedule should be adhered to.
L- iskeda rakkommandata għandha tinżamm.
Once initiated, the primary course of vaccination should be completed with the same vaccine.
La darba jinbeda, l- kors primarju ta ’ vaċċinazzjoni għandu jitkompla bl- istess vaċċin.
- Booster dose
- Doża ta ’ rinforz.
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 kinetics of antibody decline are also similar.
L- antikorpi jonqsu wkoll bl- istess kinetika.
General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines.
Gwidi ġenerali għal vaċċinazzjoni ta ’ rinforz għalhekk jistgħu jittieħdu minn esperjenzi 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.