qanastek/EMEA-V3 huggingface dataset:
Dispose of in accordance with local regulations
Armi skond il- liġijiet lokali
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MONODOSE VIAL
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN FJALA B’ DOŻA WAĦDA
Tritanrix HepB – Suspension for injection DTPw-HBV vaccine I. M.
Tritanrix HepB - Suspensjoni għall- injezzjoni Vaċċin DTPw- HBV I. M.
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA FJALA B’ ĦAFNA DOŻI
Suspension for injection 1 vial 2 doses (1 ml)
Suspensjoni għall- injezzjoni Fjala waħda 2 dożi (1 ml)
25 EXP:
JIS:
26 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIDOSE VIAL
26 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN FJALA B’ ĦAFNA DOŻI
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA FJALA B’ ĦAFNA DOŻI
Suspension for injection 1 vial 10 doses (5 ml)
Suspensjoni għall- injezzjoni Fjala waħda 10 dożi (5 ml)
28 EXP:
JIS:
29 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIDOSE VIAL
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN FJALA B’ ĦAFNA DOŻI
10 doses (5 ml)
10 dożi (5 ml)
31 PACKAGE LEAFLET:
31 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GHAL MIN QED JAGHMEL UZU MINNHA
Tritanrix HepB suspension for injection Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Titanrix HepB suspensjoni għall- injezzjoni Vaċċin (adsorbit) tad- difterite (D), tetnu (T), pertussis (ċellula sħiħa) (Pw) u epatite B (rDNA) (HBV)
Read all of this leaflet carefully before your child starts receiving this vaccine.
Aqra sew dan il- fuljett kollu qabel ma ibnek/ bintek jingħata / tingħata dan il- vaċċin
- This vaccine has been prescribed for your child.
- Din it- tilqima ġiet mogħtija lill- ibnek/ bintek.
What Tritanrix HepB is and what it is used for 2.
X’ inhu Tritanrix HepB u għalxiex jintuża 2.
Before your child receives Tritanrix HepB 3.
Qabel ibnek/ bintek jieħu/ tieħu Tritanrix HepB 3.
How Tritanrix HepB is given 4.
Kif għandu jingħata Tritanrix HepB 4.
How to store Tritanrix HepB 6.
Kif taħżen Tritanrix HepB 6.
WHAT TRITANRIX HepB IS AND WHAT IT IS USED FOR
X’ INHU TRITANRIX HepB U GĦALXIEX JINTUŻA
Tritanrix HepB is a vaccine used in children to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough) and hepatitis B.
Tritanrix HepB huwa vaċċin użat fit- tfal biex jilqa ’ kontra erba ’ mardiet: difterite, tetnu (lockjaw), pertussis (sogħla konvulsiva) u epatite B.
The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Il- vaċċin jaħdem billi jġiegħel lill- ġisem jipproduċi l- protezzjoni (antikorpi) tiegħu innifsu kontra dan il- mard.
• Diphtheria:
• Id- difterite:
Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.
Ġeneralment il - passaġġi tan- nifs jiffjammaw (jintefħu) u dan jikkawża diffikultajiet serji fit- teħid tan- nifs u kultant mewt bit- taħniq.
The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.
Il- batterji jerħu wkoll tossin (velenu), li jista ’ jikkawża ħsara fin- nervituri, problemi tal - qalb u anke jikkawża l- mewt.
• Tetanus (Lockjaw):
• It- tetnu (lockjaw):
Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Il- batterji tat- tetnu jidħlu fil- ġisem minn qtugħ, grif jew ġrieħi fil- ġilda.
Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/ dung or wood splinters.
Ġrieħi li l - aktar għandhom tendenza li jinfettaw huma l- ħruq fil- ġilda, il- ksur fl- għadam, ġrieħi fondi jew ġrieħi mniġġsa bil- ħamrija, trab, ħmieġ/ demel taż- żwiemel jew skald ta ’ l- injam.
The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death.
Il- batterji jerħu tossin (velenu), li jista ’ jikkawża ebusija fil- muskoli, spażmi li jweġġgħu fil- muskoli, aċċessjonijiet u anki mewt.
• Pertussis (Whooping cough):
• Il- pertussis (sogħla konvulsiva):
The disease affects the airways causing severe spells of coughing that may interfere with normal breathing.
Il- marda taffetwa l- passaġġi tan - nifs u tikkawża attakki serji ta ’ sogħla li jistgħu jaffettwaw it- teħid normali tan- nifs.
The coughing is often accompanied by a “ whooping” sound, hence the common name “ whooping cough”.
Is- sogħla ħafna drabi ġġib magħha ħoss qawwi ta ’ tħarħir (whooping), mnejn ġie l- isem komuni ‘ whooping cough ’ (sogħla konvulsiva).
Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death.
Il- pertussis tista ’ wkoll tikkawża infezzjonijiet fil- widnejn, bronkite li tista ’ tieħu fit- tul, pulmonite, aċċessjonijiet, ħsara fuq il - moħħ u saħansitra mewt.
Hepatitis B is caused by the hepatitis B virus.
L- epatite B hija kkawżata mill- virus ta ’ l- epatite B.
It causes the liver to become inflamed and swollen.
Hija ġġiegħel il- fwied jifjamma u jintefaħ.
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Il- virus jinsab fil- likwidi tal- ġisem bħad- demm, is- semen, it- tisfija tal- vaġina, jew is- saliva (bżiq) tal- persuni infettati.
Vaccination is the best way to protect against these diseases.
It- tilqim hu l- aħjar mezz biex tilqa ’ kontra dan il- mard.
None of the components in the vaccine are infectious.
L- ebda komponenti fil- vaċċin m’ huma infettivi.
BEFORE YOUR CHILD RECEIVES TRITANRIX HepB
QABEL IBNEK/ BINTEK JINGĦATA/ TINGĦATA TRITANRIX HepB
Tritanrix HepB should not be given:
Tagħtix Tritanrix HepB:
32 • if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in this vaccine.
• jekk ibnek/ bintek qatt kellu/ kellha xi reazzjoni allerġika għal Tritanrix HepB, jew għal kwalunke ingredjent li fih dan il- vaċċin.
The active substances and other ingredients in Tritanrix HepB are listed at the end of the leaflet.
Is- sustanzi attivi u l- ingredjenti l- oħra li jinstabu fi Tritanrix HepB huma elenkati fl- aħħar ta` dan il- fuljett.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough) or hepatitis B diseases. • if your child experienced problems of the nervous system within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease. • if your child has a severe infection with a high temperature (over 38°C).
Sinjali ta` reazzjoni allerġika jistgħu jinkludu, raxx fil- ġilda li jġagħlek tħokk, qtugħ ta ’ nifs, u nefħa fil- wiċċ jew fl- ilsien. • jekk ibnek/ bintek kellu/ kellha xi reazzjoni allerġika għal kwalunkwe vaċċin kontra l- mard tad- difterite, tetnu, pertussis (sogħla konvulżiva) jew epatite B. • jekk ibnek/ bintek kellu/ kellha xi problemi fis- sistema nervuża fi żmien 7 ijiem wara li fil- passat tlaqqam/ tlaqqmet kontra l- marda tal- pertussis (sogħla konvulżiva). • jekk ibnek/ bintek għandu/ għandha xi infezzjoni qawwija b`deni għoli (’ l fuq minn 38°C).
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Infezzjoni ħafifa bħal riħ, m’ għandiex tkun problema, iżda l- ewwel dejjem ikkonsulta mat- tabib tiegħek.
Take special care with Tritanrix HepB:
Oqogħod attent ħafna b’ Tritanrix HepB:
• if your child has experienced any health problems after previous administration of a vaccine. • if after previously having Tritanrix HepB or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/ fits with or without a high temperature within 3 days of vaccination • if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
• jekk ibnek/ bintek qatt kellu/ kellha problemi ta ’ saħħa meta fil- passat ingħata/ ingħatat vaċċin. • jekk wara xi tilqim fil- passat b’ Tritanrix HepB jew b’ xi vaċċin ieħor kontra l- pertussis (sogħla konvulżiva), ibnek/ bintek kellu/ kellha xi problemi speċjalment: ♦ Deni għoli (‘ l fuq minn 40° C) fi żmien 48 siegħa mit- tilqim ♦ Kollass jew stat bħal f’ xokk fi żmien 48 siegħa mit- tilqim ♦ Biki persistenti li jdum tliet sigħat jew aktar fi żmien 48 siegħa mit- tilqim ♦ Aċċessjonijiet / konvulżjonijiet b`deni għoli jew mingħajr deni għoli fi żmien 3 ijiem mit- tilqim • jekk ibnek/ bintek qed ibatu minn xi marda tal- moħħ mhux dijanjostikata jew progressiva jew epilessija mhux ikkontrollata.
After control of the disease the vaccine should be administered • if your child has a bleeding problem or bruises easily • if your child has a tendency to seizures/ fits due to a fever, or if there is a history in the family of this
Wara li l- marda tiġi kkontrollata, il- vaċċin għandu jingħata. • jekk ibnek/ bintek għandu/ għandha problema ta ’ fsada jew jekk jitbenġel/ titbenġel malajr • jekk ibnek/ bintek għandu/ għandha tendenza għall- aċċessjonijiet/ konvulżjonijiet minħabba deni għoli, jew jekk hemm storja ta ’ dan fil- familja
Using other medicines or vaccines Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Meta tieħu mediċini jew tilqim ieħor Jekk jogħġbok għid lit- tabib tiegħek jekk ibnek/ bintek qed jieħu/ tieħu jew jekk riċentement irċieva/ irċeviet kwalunkwe mediċina oħra, inkluż mediċini li jinkisbu mingħajr riċetta jew jekk riċentement irċieva/ irċeviet kwalunkwe vaċċin ieħor.
Important information about some of the ingredients of Tritanrix HepB This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction.
Informazzjoni importanti dwar xi wħud mill- ingredjenti ta ’ Tritanrix HepB Dan il- prodott mediċinali fih thiomersal bħala preservattiv u huwa possibbli li ibnek/ bintek ikollu/ ikollha reazzjoni allerġika.
Tell your doctor if your child has any known allergies.
Għid lit- tabib tiegħek jekk ibnek/ bintek għandu/ għandha xi allerġiji li taf bihom.
HOW TRITANRIX HepB IS GIVEN
KIF GĦANDU JINGĦATA TRITANRIX HepB
If additional injections are necessary, the doctor will tell you.
It- tabib tiegħek jinfurmak jekk ikun hemm bżonn ta ’ dożi żejda.
If your child misses a scheduled injection, talk to your doctor and arrange another visit.
Jekk ibnek/ bintek jitlef/ titlef injezzjoni skedata, kellem lit- tabib tiegħek u agħmel arranġament għal vista oħra.
Make sure your child finishes the complete vaccination course of three injections.
Żgura li ibnek/ bintek jispiċċa/ tispiċċa l- kors kollu ta ’ tlett injezzjonijiet ta ’ tilqim.
The doctor will give Tritanrix HepB as an injection into the thigh muscle.
It- tabib jagħti Tritanrix HepB bħala injezzjoni ġol- muskolu.
Your child will remain under medical supervision for 30 minutes after each injection.
Ibnek/ bintek jibqa ’ / tibqa ’ taħt superviżjoni medika għal 30 minuta wara kull injezzjoni.
The vaccine should never be given into a vein.
33 Il- vaċċin m’ għandu qatt jingħata fil- vina.
Like all medicines, Tritanrix HepB can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Tritanrix HepB jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
33 Side effects that occurred during clinical trials with Tritanrix HepB were as follows:
Effetti sekondarji li ġraw waqt provi kliniċi bi Tritanrix HepB kienu kif ġej:
♦ Very common (side effects which may occur in more than 1 per 10 doses of vaccine): • pain or discomfort at the injection site • redness or swelling at the injection site • fever (more than 38°C) • drowsiness, irritability, unusual crying • feeding problems
♦ Komuni ħafna (effetti sekondarji li jistgħu jiġru f’ aktar minn każ wieħed minn kull 10 dożi ta ’ vaċċin): • uġigħ jew skonfort fis- sit ta ’ l- injezzjoni • ħmura jew nefħa fis- sit ta ’ l- injezzjoni • deni (aktar minn 38°C) • ħeddla, irritabbilità, biki mhux normali • problemi meta titma ’ lit- tarbija
♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine): • infection of the middle ear • bronchitis • sore throat and discomfort when swallowing • gastrointestinal symptoms such as vomiting and diarrhoea
♦ Komuni (effetti sekondarji li jistgħu jiġru f’ anqas minn każ wieħed minn kull 10 dożi iżda f’ aktar minn każ wieħed minn kull 100 doża ta ’ vaċċin): • infezzjoni tal- widna tan- nofs • bronkite • uġigħ fil- ġerżuma u skonfort meta tibla ’ • sintomi gastro- intestinali bħal rimettar u dijarea
♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine): • pneumonia (serious lung infection) • respiratory disorder
♦ Mhux komuni (effetti sekondarji li jistgħu jiġru f’ anqas minn każ wieħed minn kull 100 doża iżda f’ aktar minn każ wieħed minn kull 1, 000 doża ta ’ vaċċin): • pulmonite (infezzjoni serja tal- pulmun) • disturb respiratorju
♦ Very rare (side effects which may occur in less than 10,000 doses of vaccine): • allergic reactions, including anaphylactic and anaphylactoid reactions.
♦ Rari ħafna (effetti sekondarji li jistgħu jiġru f’ anqas minn każ wieħed minn kull 10, 000 doża ta ’ vaċċin): • reazzjonjiet allerġiċi inkluż reazzjonijiet anafilattiċi u anafilaktojd.
These may be local or widespread 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.
Dawn jistgħu jkunu raxx lokali jew mifrux fejn ikun hemm ħakk jew jitilgħu l- bżieżaq, nefħa fl- għajnejn jew fil- wiċċ, diffikultà biex tieħu n- nifs jew tibla ’, pressjoni li taqa ’ f’ daqqa u telf ta ’ koxjenza.
Such reactions may occur before leaving the doctor’ s surgery.
Reazzjonijiet bħal dawn jistgħu jiġru qabel ma ’ titlaq mingħand it- tabib.
However, you should seek immediate treatment in any event. • serum sickness like disease (a hypersensitivity reaction to the administration of a foreign serum with symptoms like fever, swelling, skin rash, enlargement of the lymph nodes)
Madankollu, għandek tfittex trattament mill- ewwel f’ kull każ. • marda tixbaħ lil serum sickness (reazzjoni ta ’ ipersensittività għall- amministrazzjoni ta ’ serum barrani b’ sintomi ta ’ deni, nefħa, raxx fil- ġilda u tkabbir tal- glandoli limfatiċi)
After the marketing of Tritanrix HepB, the following additional side effects have been reported on a few occasions:
Wara t- tqegħid fis- suq ta ’ Tritanrix HepB, l- effetti sekondarji oħra li ġejjin ġew irrappurtati xi kultant:
• collapse or periods of unconsciousness or lack of awareness have been reported within 2 to 3 days after vaccination • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
fi trabi mwieldin ħafna qabel iż- żmien (fi jew qabel it- 28 ġimgħa ta ’ tqala) jista ’ jkun hemm perjodi itwal minn normal bejn nifs u ieħor għal 2- 3 ijiem wara t- tilqim
Tritanrix HepB contains a hepatitis B component, to provide protection against disease caused by hepatitis B virus.
Tritanrix HepB fiha komponent ta ’ l- epatite B biex tagħti protezzjoni kontra l- marda ikkawżata permezz tal - virus ta ’ l- epatite B.
The following undesirable events have occurred very rarely following the administration of hepatitis B containing vaccines: ♦ seizures or fits ♦ bleeding or bruising more easily than normal
Dawn l- effetti mhux mixtieqa li ġejjin ġraw f’ każijiet rari ħafna, wara l - amministrazzjoni ta ’ tilqim li kien fih l- epatite B: ♦ kunvulżjonijiet jew aċċessjonijiet ♦ fsada jew tbenġil aktar malajr mis- soltu
HOW TO STORE TRITANRIX HepB
KIF TAĦŻEN TRITANRIX HepB
Do not use Tritanrix HepB after the expiry date which is stated on the carton.
Tużax Tritanrix HepB wara d- data ta ’ skadenza li tidher fuq il- kartuna.
34 Store in a refrigerator (2°C – 8°C) Store in the original package in order to protect from light.
Aħżen fi friġġ (2°C – 8°C) Żommu fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
What Tritanrix HepB contains
X’ fih Tritanrix HepB
- The active substances contained in 1 dose (0.5 ml) are:
- Is- sustanza attiva li fiha doża waħda (0. 5 ml) hija:
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis (inactivated)2 Hepatitis B surface antigen2,3
Toxoid tad- difterite1 Toxoid tat- tetnu1 Bordetella pertussis (inattivat) 2 Antiġen tal- wiċċ ta ’ l- epatite B2, 3
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA
0. 26 mg Al3+ adsorbit fuq aluminium hydroxide idratat 2 0. 37 mg Al3+ adsorbit fuq aluminium phosphate 3 manifatturat f’ ċelluli tal- ħmira (Saccharomyces cerevisiae) b’ teknoloġija rikombinanti tad- DNA
- The other ingredients in Tritanrix HepB are: thiomersal, sodium chloride and water for injections.
- Is- sustanzi l- oħra fi Tritanrix HepB huma: thiomersal, sodium chloride u ilma għall- injezzjonijiet.
What Tritanrix HepB looks like and contents of the pack
Id- Dehra ta ’ Tritanrix HepB u l- kontenuti tal- pakkett:
Tritanrix HepB is a white, slightly milky liquid presented in a glass vial for 1 dose (0.5 ml).
Tritanrix HepB huwa likwidu abjad qisu ħalib fi fjala tal- ħġieġ li fiha doża waħda (0. 5ml).
Tritanrix HepB is available in pack of 1.
Tritanrix HepB huwa disponibbli f’ pakkett bi fjala waħda.
Rue de l’ Institut 89 B-1330 Rixensart Belgium
Rue de l`Institut 89 B- 1330 Rixensart Il- Belġju
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
35 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- Suq:
Suomi/ Finland GlaxoSmithKline Oy Puh/ Tel: + 358 10 30 30 30 Finland. tuoteinfo@gsk. com
36 Suomi/ Finland GlaxoSmithKline Oy Puh/ Tel: + 358 10 30 30 30 Finland. tuoteinfo@ gsk. com
36 Tel: +370 5 264 90 00 info. lt@gsk. com
Dan il- fuljett kien approvat l- aħħar f ’
This leaflet was last approved in 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- medicina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. ------------------------------------------------------------------------------------------------------------------------------
This does not constitute a sign of deterioration.
Dan m’ huwiex sinjal li l- prodott ħżien.
The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and be inspected visually for any foreign particulate matter and/ or variation of physical aspect.
Il- vaċċin għandu jitħawwad sew biex tinkiseb suspensjoni uniformi, bajda u imdardra u għandu jiġi mifli viżwalment għal xi frak u/ jew dehra fiżika mhux normali.
In the event of either being observed, discard the container.
F’ każ li xi waħda minn dawn tiġi osservata, armi l - vaċċin.
Tritanrix HepB suspension for injection, multidose Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Titanrix HepB suspensjoni għall- injezzjoni, ħafna dożi Vaċċin (adsorbit) tad- difterite (D), tetnu (T), pertussis (ċellula sħiħa) (Pw) u epatite B (rDNA) (HBV)
38 • if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in this vaccine.
• jekk ibnek/ bintek qatt kellu/ kellha xi reazzjoni allerġika għal Tritanrix HepB, jew għal kwalunke ingredjent li fih dan il- vaċċin.
The vaccine should never be given into a vein.
39 Il- vaċċin m’ għandu qatt jingħata fil- vina.
39 Side effects that occurred during clinical trials with Tritanrix HepB were as follows:
Effetti sekondarji li ġraw waqt provi kliniċi bi Tritanrix HepB kienu kif ġej:
40 Store in a refrigerator (2°C – 8°C) Store in the original package in order to protect from light.
Aħżen fi friġġ (2°C – 8°C) Żommu fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
Suspension for injection, multidose.
Suspensjoni għall- injezzjoni.
Tritanrix HepB is a white, slightly milky liquid presented in a glass vial for 2 doses (1 ml) or in a glass vial for 10 doses (5 ml).
Tritanrix HepB huwa likwidu abjad qisu ħalib fi fjala tal- ħġieġ għal 2 dożi (1ml) jew fi fjala tal- ħġieġ għal 10 dożi (5ml).
Tritanrix HepB is available in the following pack sizes:
Tritanrix HepB huwa disponibbli fil- pakketti li ġejjin:
For 2 doses: pack size of 1 For 10 doses: pack size of 1
Għal 2 dożi: pakkett bi fjala waħda Għal 10 dożi: pakkett bi fjala waħda
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
41 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- Suq:
Tel: + 421 (0)2 48 26 11 11 recepcia. sk@gsk. com
Tel: +421 (0) 2 48 26 11 11 recepcia. sk@ gsk. com
Suomi/ Finland GlaxoSmithKline Oy Puh/ Tel: + 358 10 30 30 30 Finland. tuoteinfo@gsk. com
42 Suomi/ Finland GlaxoSmithKline Oy Puh/ Tel: + 358 10 30 30 30 Finland. tuoteinfo@ gsk. com
Tel: + 44 (0)808 100 9997 customercontactuk@gsk. com
United Kingdom GlaxoSmithKline UK Tel: + 44 (0) 808 100 9997 customercontactuk@ gsk. com
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- medicina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. ------------------------------------------------------------------------------------------------------------------------------
What is Trizivir?
X’ inhu Trizivir?
Trizivir is a medicine containing three active substances: abacavir (300 mg), lamivudine (150 mg) and zidovudine (300 mg).
Trizivir hija mediċina li fiha tliet sustanzi attivi: abacavir (300 mg), lamivudine (150 mg) u zidovudine (300 mg).
It is available as blue-green, capsule-shaped tablets.
Tiġi bħala pilloli blu fl- aħdar b’ forma ta ’ kapsuli.
What is Trizivir used for?
Għal xiex jintuża Trizivir?
Trizivir is an antiviral medicine.
Trizivir hija mediċina antivirali.
It is used to treat adults who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Tintuża fit- trattament ta ’ adulti li jkunu infettati bil- vajrus ta ’ l - immunodefiċjenza umana (HIV), il- vajrus li jikkawża s- sindromu tad- defiċenza immunitarja (l- AIDS).
It is used to replace treatment with the three components taken at doses similar to those in Trizivir.
Tintuża biex tieħu post it- trattament bit- tliet komponenti meħuda f’ dożi simili bħal dawk f’ Trizivir.
Patients should have already been taking the three active substances separately for at least six to eight weeks before switching to Trizivir.
Il - pazjenti jridu jkunu diġà qed jieħdu t- tliet sustanzi attivi separatament għal mill- inqas sitta u tmien ġimgħat qabel ma jaqilbu għal Trizivir.
Doctors should prescribe Trizivir after considering the expected improved ability of the patient to stick to their treatment, the expected effectiveness of the medicine, and the risk associated with the active substances.
It- tobba għandhom jippreskrivu Trizivir wara li jkunu kkunsidraw it- titjib mistenni fl- abilità tal - pazjent li jżomm mat- trattament, l- effikaċja mistennija tal- mediċina, u r- riskju assoċjat mas- sustanzi attivi.
They should prescribe Trizivir to patients with high levels of HIV in the blood (above 100,000 copies/ ml) only after careful consideration.
Għandhom jippreskrivu Trizivir lil pazjenti b’ livelli għoljin ta ’ HIV fid- demm (iktar minn 100, 000 kopji/ ml) wara konsiderazzjoni xierqa.
How is Trizivir used?
Kif jintuża Trizivir?
Treatment with Trizivir should be initiated by a doctor who has experience in the management of HIV infection.
It- trattament b’ Trizivir għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni ta ’ l- infezzjoni ta ’ l - HIV.
The recommended dose of Trizivir for patients over 18 years of age is one tablet twice a day, with or without food.
Id- doża rakkomandata ta ’ Trizivir għal pazjenti ta ’ iktar minn 18- il sena hija ta ’ pillola waħda darbtejn kuljum, ma ’ jew mingħajr l- ikel.
If patients need to stop taking abacavir, lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing abacavir, lamivudine or zidovudine separately.
Jekk il- pazjenti jkollhom bżonn jieqfu jieħdu abacavir, lamivudine jew zidovudine, jew ikollhom bżonn jieħdu dożi differenti minħabba problemi fil- kliewi, fil- fwied jew fid- demm, ikollhom jieħdu mediċini li jkun fihom abacavir, lamivudine jew zidovudine separatament.
For more information, see the Package Leaflet.
Trizivir m’ għandux jittieħed minn pazjenti li jkollhom problemi bil- fwied jew falliment tal- kliewi, Għal aktar tagħrif, ara l- Fuljett ta ’ Tagħrif.
Patients who take Trizivir must be given the special alert card that summarises the key safety information about the medicine.
Il- pazjenti li jieħdu Trizivir għandhom jingħataw il- kard speċjali tat- twissija li tagħti t- tagħrif ewlieni fil- qosor dwar is- sigurtà tal- mediċina.
How does Trizivir work?
Kif jaħdem Trizivir?
All three active substances in Trizivir, abacavir, lamivudine, and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
It- tliet sustanzi attivi f’ Trizivir, abacavir, lamivudine, u zidovudine, huma nucleoside reverse transcriptase inhibitors (NRTIs).
They all work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Kollha kemm huma jaħdmu b’ mod simili billi jimblukkaw l- attività tar- reverse transcriptase, enzim prodott mill- HIV li jippermettilu li jinfetta ċ- ċelloli u li jagħmel iktar vajrusis.
Trizivir reduces the amount of HIV in the blood and keeps it at a low level.
Trizivir inaqqas l- ammont ta ’ HIV fid- demm u jżommu f’ livell baxx.
Trizivir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Trizivir ma jfejjaqx l -
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged All three active substances were previously available in the European Union (EU): abacavir was granted marketing authorisation as Ziagen in 1999, lamivudine was granted marketing authorisation as Epivir in 1996, and zidovudine has been available in the EU since the mid-1980s.
It- tliet sustanzi attivi kienu diġà disponibbli fl- Unjoni Ewropea (UE): abacavir ingħata l - awtorizzazzjoni għat- tqegħid fis- suq bħala Epivir fl- 1996, u zidovudine ilu disponibbli fl- UE sa minn nofs it- tmeninijiet.
How has Trizivir been studied?
Kif ġie studjat Trizivir?
No specific clinical studies have been carried out with the combined tablet.
Ma saru l- ebda studji kliniċi speċifiċi bil- pillola kombinata.
The company presented the results of studies of abacavir, lamivudine and zidovudine taken together, as carried out during the development of Ziagen.
Il- kumpanija ppreżentat ir- riżultati ta ’ studji ta ’ abacavir, lamivudine u zidovudine meħudin flimkien, kif saru waqt l- iżvilupp ta ’ Ziagen.
The company also looked at the way the combined tablet was absorbed in the body in comparison to the separate tablets.
Il - kumpanija rat ukoll il- mod kif il- pillola kombinata ġiet assorbita fil- ġisem meta mqabbla ma ’ pilloli separati.
What benefit has Trizivir shown during the studies?
X’ inhu l- benefiċċju ta ’ Trizivir li ntwera f’ dawn l- istudji?
In the studies carried out for the development of Ziagen, the combination of the three active substances was shown to be at least as effective as the comparator combinations in keeping viral loads low.
F’ dawn l- istudji li saru għall- iżvilupp ta ’ Ziagen, intwera li l- kombinazzjoni tat- tliet sustanzi attivi kienet effettiva ta ’ l- inqas daqs il- kombinazzjonijiet tat- tqabbil fiż- żamma tat- tagħbijiet virali f’ livelli baxxi.
The combination tablet was absorbed in the body in the same way as the separate tablets
Il- pillola tal- kombinazzjoni kienet assorbita fil- ġisem bl- istess mod bħall- pilloli separati.
What is the risk associated with Trizivir?
X’ inhu r- riskju assoċjat ma ’ Trizivir?
The most common effects when taking Trizivir (seen in more than 1 patient in 10) are headache and nausea (feeling sick).
L- iktar effetti sekondarji komuni tat- teħid ta ’ Trizivir (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma l- uġigħ ta ’ ras u d- dardir.
For the full list of all side effects reported with Trizivir, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Trizivir, ara l- Fuljett ta ’ Tagħrif.
Hypersensitivity reactions (allergic reactions) occur in about 5% of patients taking Trizivir, usually within the first six weeks of treatment.
Iseħħu reazzjonijiet allerġiċi f’ madwar 5% tal- pazjenti li jieħdu Trizivir, ġeneralment fl- ewwel sitt ġimgħat ta ’ trattament.
Some of these cases can be fatal.
Xi wħud minn dawn il- każi jistgħu jkunu fatali.
Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain, headache, signs of liver damage in the blood, myalgia (muscle pain), dyspnoea (difficulty breathing), cough, lethargy and malaise (feeling unwell).
Fost is- sintomi dejjem ikun hemm deni jew raxx, iżda ħafna drabi jinkludu wkoll dardir, remettar, dijarea, uġigħ ta ’ żaqq, uġigħ ta ’ ras, sinjali fid- demm ta ’ ħsara fil- fwied, uġigħ fil- muskoli, qtugħ ta ’ nifs, sogħla u telqa.
Patients treated with Trizivir receive a card detailing these symptoms so that they are aware of them, and must contact their doctor immediately if they develop a reaction.
Il- pazjenti ttrattati b’ Trizivir jingħataw kard li fiha jkunu mniżżlin dawn is- sintomi sabiex ikunu konxji tagħhom, u għandhom jikkuntattjaw lit- tabib tagħhom immedjatament jekk jiżviluppaw xi reazzjoni.
Trizivir should not be used in patients who may be hypersensitive (allergic) to lamivudine, zidovudine, abacavir or any of the other ingredients, who have problems with their liver, or who have kidney failure.
Trizivir m’ għandux jintuża għal pazjenti li jista ’ jkollhom allerġija għal lamivudine, zidovudine, abacavir jew għal kwalunkwe sustanza oħra, li jkollhom problemi fil- fwied, jew li jkollhom falliment fil- kliewi.
Because it contains zidovudine, it should also not be used by patients with low neutrophil (a type of white blood cell) counts or anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body).
Billi fih zidovudine, m’ għandux jintuża minn pazjenti b’ livell baxx ta ’ neutrophil (tip ta ’ ċelloli tad- demm bojod) jew anemija (livelli baxxi ta ’ emoglobina, il- proteina fiċ- ċelloli tad- demm ħomor li ġġorr l- ossiġenu madwar il- ġisem).
As with other anti-HIV medicines, patients taking Trizivir may be at risk of developing lipodystrophy (changes in the distribution of body fat), immune reactivation syndrome (reactions to disease-causing organisms by the recovering immune system) and osteonecrosis (death of cells in the bone, which makes the bones fragile).
Bħal fil- każ ta ’ mediċini oħra kontra l- HIV, il- pazjenti li jkunu qed jieħdu Trizivir jistgħu jkunu f’ riskju li jiżviluppaw lipodistrofija (tibdiliet fid- distribuzzjoni tax- xaħam fil- ġisem), is- sindromu tar - riattivazzjoni immunitarja (reazzjonijiet għal organiżmi li jikkawżaw mard mis- sistema immunitarja li tkun qed tirkupra), u osteonekrożi (mewt ta ’ ċelloli fl- għadam, li jagħmel l- għadam iktar fraġli).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Trizivir.
Il - pazjenti li jkollhom problemi bil- fwied (inkluż infezzjoni ta ’ l- epatite B jew Ċ) jista ’ jkollhom riskju ikbar ta ’ ħsara fil- fwied meta jieħdu Trizivir.
As with all NRTIs, Trizivir may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Trizivir during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Bħal fil- każ ta ’ l- NRTIs kollha, Trizivir jista ’ jikkawża wkoll l- aċidożi lattika (akkumulazzjoni ta ’ aċidu lattiku fil- ġisem) u, fit- trabi ta ’ ommijiet li jkunu qed jieħdu Trizivir waqt it- tqala, disfunzjoni mitokondrijaka (ħsara fil- komponenti ta ’ ġoċ- ċelloli li jipproduċu l- enerġija li jistgħu jikkawżaw problemi fid- demm).
Why has Trizivir been approved?
Għaliex ġie approvat Trizivir?
The Committee for Medicinal products for Human Use (CHMP) decided that Trizivir’ s benefits are greater than its risks for the treatment of HIV infection in adults.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Trizivir huma ikbar mir- riskji tiegħu għat- trattament ta ’ infezzjoni bl- HIV fl- adulti.
This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar dosages.
Din il - kombinazzjoni fissa tieħu post it- tliet komponenti (abacavir, lamivudine u zidovudine) użati separatament f’ dożi simili.
The Committee noted that the reduction in the number of tablets that patients need to take may help patients to stick to their treatment, and that the benefit of Trizivir has mainly been shown in patients who have had little or no previous HIV treatment and who have non-advanced disease.
Il- Kumitat innota li t- tnaqqis fin- numru ta ’ pilloli li jkollhom jieħdu l - pazjenti jista ’ jgħin lill- pazjenti jżommu aħjar mat- trattament, u li l- benefiċċju ta ’ Trizivir intwera primarjament f’ pazjenti li ftit li xejn ikunu ħadu trattament għall- HIV u li jkollhom il- marda fi stat mhux avvanzat.
The Committee recommended that Trizivir be given marketing authorisation.
Il- Kumitat irrakkomanda li Trizivir jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Trizivir:
Tagħrif ieħor dwar Trizivir:
The European Commission granted a marketing authorisation valid throughout the EU for Trizivir to Glaxo Group Ltd on 28 December 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Trizivir valida għall- Unjoni Ewropea kollha lil Glaxo Group Ltd fit- 28 ta ’ Diċembru 2000.
The marketing authorisation was renewed on 28 December 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 28 ta ’ Diċembru 2005.
The full EPAR for Trizivir is available here.
L- EPAR sħiħ għal Trizivir huwa disponibbli minn hawn.
TRIZIVIR 300 mg/ 150 mg/ 300 mg film-coated tablets
TRIZIVIR pilloli ta ’ 300mg/ 150mg/ 300mg miksijin b' rita
Each film-coated tablet contains 300 mg of abacavir (as sulfate), 150 mg lamivudine and 300 mg zidovudine.
Kull pillola miksija b' rita jkun fiha 300 mg abacavir (bħala sulfate), 150 mg lamivudine u 300 mg zidovudine
For a full list of excipients see section 6.1.
6. 1
Blue-green capsule-shaped film-coated tablets engraved with “ GX LL1” on one side.
Pilloli blu- ħodor f' għamla ta 'kapsula miksijin b' rita u “ GX LL1 "mnaqqxa fuq naħa waħda.
Trizivir is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults.
Trizivir huwa indikat bħala trattament għal adulti kontra l- infezzjoni mill- Virus ta 'l - Immunodefiċjenza fil- Bniedem (HIV).
This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar dosages.
Din it- taħlita fissa tissostitwixxi t- tlett komponenti (abacavir, lamivudine u zidovudine) li jintużaw separatament f' dożaġġi simili.
It is recommended that treatment is started with abacavir, lamivudine, and zidovudine separately for the first 6-8 weeks (see section 4.4).
Hu rakkomandat li l- kura tibda b’ abacavir, lamivudine u zidovudine separatament għall- ewwel 6- 8 ġimgħat (ara sezzjoni 4. 4).
The choice of this fixed combination should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three nucleoside analogues.
L- għażla ta 'din it- taħlita fissa għandha tkun bażata mhux biss fuq kriterji ta' adeżjoni potenzjali, iżda prinċipalment fuq l- effikaċja mistennija u riskji relatati mat- tlett nukleosidi analogi.
The demonstration of the benefit of Trizivir is mainly based on results of studies performed in treatment naive patients or moderately antiretroviral experienced patients with non-advanced disease.
Il- wirja tal- benefiċċju ta ’ Trizivir hi bażata l- aktar fuq riżultati ta 'studji mwettqa fuq it- trattament ta' pazjenti inġenwi jew pazjenti b' esperjenza antiretrovirali moderata b' disturbi mhux avanzat.
In patients with high viral load (> 100,000 copies/ ml) choice of therapy needs special consideration (see section 5.1).
F' pazjenti bi piż virali għoli (> 100, 000 kopji/ ml) l- għażla tat- terapija teħtieġ kunsiderazzjoni speċjali (ara t - taqsima 5. 1).
Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin.
Qabel ma tinbeda kura b’ abacavir, għanda ssir investigazzjoni għall- ġarr ta ’ l- allel HLA - B* 5701 f’ kull pazjent infettat bl- HIV, irrispettavament mir- razza.
Therapy should be prescribed by a physician experienced in the management of HIV infection.
It- terapija għandha tiġi preskritta minn tabib ta 'esperjenza fil- maniġġar ta' l- infezzjoni HIV.
The recommended dose of Trizivir in adults (18 years and over) is one tablet twice daily.
Id- doża rakkomandata ta 'Trizivir fil- kbar (18- il sena' l fuq) hi ta 'pillola waħda darbtejn kuljum.
Trizivir can be taken with or without food.
Trizivir jista 'jittieħed ma' l- ikel jew mhux ma 'l- ikel.
Where discontinuation of therapy with one of the active substances of Trizivir is indicated, or where dose reduction is necessary separate preparations of abacavir, lamivudine and zidovudine are available.
Meta jkun indikat li t- terapija bis- sustanzi attivi ta ’ Trizivir għandha titwaqqaf, jew meta jkun meħtieġ tnaqqis fid- doża jibqgħu disponibbli preparazzjonijiet separati ta 'abacavir, lamivudine u zidovudine.
Renal impairment:
Ħsara fil- kliewi:
Whilst no dosage adjustment of abacavir is necessary in patients with renal dysfunction, lamivudine and zidovudine concentrations are increased in patients with renal impairment due to decreased clearance.
Filwaqt li f' pazjenti b' funzjonament ħażin tal- kliewi m' hemmx bżonn ta 'aġġustament tad- dożaġġi, konċentrazzjonijiet ta' lamivudine u zidovudine jiżdiedu f' pazjenti bi ħsara fil- kliewi 2 minħabba tneħħija mnaqqsa.
Therefore, as dosage adjustments of these may be necessary, it is recommended that separate preparations of abacavir, lamivudine and zidovudine be administered to
Għalhekk, filwaqt li aġġustamenti tad- dożaġġi jistgħu ikunu meħtieġa, hu rakkomandat li preparazzjonijiet separati ta 'abacavir, lamivudine u zidovudine jingħataw lil pazjenti b' funzjonament tal- fwied imnaqqas (tneħħija ta' kreatinina≤ 50 ml/ min).
Physicians should refer to the individual summary of product characteristics of these medicinal products.
Tobba għandhom jirriferixxu għat- tagħrif individwali dwar karatteristiċi tal- prodott fil- qosor ta 'dawn il- prodotti mediċinali.
Trizivir should not be administered to patients with end-stage renal disease (see sections 4.3 and 5.2).
Trizivir m' għandux jingħata lil pazjenti b' disturbi tal- kliewi fl- aħħar fażi tiegħu (ara t- taqsimiet 4. 3 u 5. 2).
Hepatic impairment:
Ħsara fil- fwied:
Trizivir is contra-indicated in patients with hepatic impairment (see sections 4.3 and 5.2).
Trizivir m' għandux jittieħed minn pazjenti bi ħsara fil- fwied (ara sezzjonijiet 4. 3 u 5. 2).
No pharmacokinetic data are currently available in patients over 65 years of age.
Ma jeżistux data farmakokinetiċi dwar pazjenti ta '' l fuq minn 65 sena.
Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
Għandha tingħata attenzjoni speċjali lil dan il- grupp ta 'nies minħabba bidliet marbuta ma' l- eta 'bħal tnaqqis fil - funzjonament tal- kliewi u tibdil fil- parametri ematoloġiċi.
Dosage adjustments in patients with haematological adverse reactions:
Aġġustamenti ta 'dożaġġ f' pazjenti b' reazzjonijiet avversi ematoloġiċi:
Dosage adjustment of zidovudine may be necessary if the haemoglobin level falls below 9 g/ dl or 5.59 mmol/ l or the neutrophil count falls below 1.0 x 109/ l (see sections 4.3 and 4.4).
Jista 'jkun meħtieġ aġġustament tad- dożaġġ ta' lamivudine jekk il- livell ta 'l- emoglobina jinżel għal inqas minn 9 g/ dl jew 5. 59 mmol/ l jew jekk l- għadd tan- neutrophil jinżel għal inqas minn 1. 0 x 109/ l (ara sezzjonjiet 4. 3 u 4. 4).
As dosage adjustment of Trizivir is not possible, separate preparations of abacavir, lamivudine and zidovudine should be used.
Billi l - aġġustament tad- dożaġġ ta ’ Trizivir mhux possibbli, għandhom jintużaw preparazzjonijiet separati ta 'abacavir, lamivudine u zidovudine.
Physicians should refer to the individual summary of product characteristics of these medicinal products.
Tobba għandhom jirriferu għat- tagħrif individwali dwar karatteristiċi tal- prodott fil- qosor ta 'dawn il- prodotti mediċinali.
Trizivir is contraindicated in patients with known hypersensitivity to abacavir, lamivudine or zidovudine, or to any of the excipients.
Trizivir m' għandux jingħata lil pazjenti b' sensittivita 'eċċessiva magħrufa għal abacavir, lamivudine jew zidovudine, jew għas- sustanzi mhux attivi.
See BOXED INFORMATION ON HYPERSENSITIVITY REACTIONS in section 4.4 and section 4.8.
Ara L- KAXXA LI FIHA TAGĦRIF DWAR REAZZJONIJIET TA 'SENSITTIVITA' EĊĊESIVA f’ sezzjoni 4. 4 u sezzjoni 4. 8.
Trizivir is contraindicated in patients with end-stage renal disease.
Trizivir m' għandux jingħata lil pazjenti b' disturbi tal- kliewi fl- aħħar fażi tiegħu.
Trizivir is contraindicated in patients with hepatic impairment.
Trizivir m' għandux jingħata lil pazjenti bi ħsara fil- fwied.
Due to the active substance zidovudine, Trizivir is contraindicated in patients with abnormally low neutrophil counts (< 0.75 x 109/ l), or abnormally low haemoglobin levels (< 7.5 g/ dl or 4.65 mmol/ l) (see section 4.4).
Minħabba s- sustanza attiva zidovudine, Trizivir m' għandux jingħata lil pazjenti b' għadd baxx mhux normali ta 'neutrophil (< 0. 75 x 109/ 1), jew livelli baxxi mhux normali ta' emoglobina (< 7. 5 g/ dl jew 4. 65 mmol/ l) (ara t- taqsima 4. 4)
The special warnings and precautions relevant to abacavir, lamivudine and zidovudine are included in this section.
L- avviżi speċjali u prekawzjonijiet relevanti għal abacavir, lamivudine u zidovudine huma inklużi f' din it- taqsima..
There are no additional precautions or warnings relevant to the combination Trizivir.
M' hemmx prekawzjonijiet jew avviżi speċjali oħra relevanti għat- taħlita Trizivir.
Hypersensitivity Reaction (see also section 4.8):
Reazzjoni ta 'Sensittivita' Eċċessiva (ara wkoll is- sezzjoni 4. 8):
In clinical studies approximately 5% of subjects receiving abacavir (which is also the active substance of Ziagen) develop a hypersensitivity reaction.
Minn studji kliniċi jirriżulta li madwar 5% ta 'suġġetti li jieħdu abacavir (li hu wkoll is- sustanza attiva ta ’ Ziagen) jiżviluppaw reazzjoni ta' sensittivita 'eċċessiva.
Some of these cases were life-threatening and resulted in a fatal outcome despite taking precautions.
Xi wħud minn dawn il- każi kienu ta 'periklu għall- ħajja u spiċċaw f' riżultat fatali minkejja t- teħid ta' prekawzjonijiet.
Studies have shown that carriage of the HLA-B*5701 allele is associated with a significantly increased risk of a hypersensitivity reaction to abacavir.
Studji urew li l- ġarr ta ’ l- allel huwa assoċjat ma ’ riskju ħafna aktar għoli ta ’ reazzjoni ta ’ sensittività eċċessiva għal abacavir.
Based on the prospective study CNA106030 (PREDICT-1), use of pre-therapy screening for the HLA-B*5701 allele and subsequently avoiding abacavir in patients with this allele significantly reduced the incidence of abacavir hypersensitivity reactions.
Skond l- istudju prospettiv CNA106030 (PREDICT- 1), l - użu ta ’ investigazzjoni għal preżenza ta ’ l- allel HLA- B* 5701 qabel il- kura u li tevita l- użu ta ’ abacavir f’ pazjenti b’ dan l- allel, naqqas b’ mod sinifikanti ir- reazzjonijiet ta ’ sensittività eċċessiva għal abacavir.
As a consequence, before initiating treatment with abacavir, screening for carriage of the HLA- B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin.
3 B’ konsegwenza ta ’ dan, qabel tibda l- kura b’ abacavir, għanda ssir investigazzjoni għall- ġarr ta ’ l- allel HLA- B* 5701 f’ kull pazjent infettat bl- HIV, irrispettivament mir- razza.
Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available based on the treatment history and resistance testing (see section 4.1).
Abacavir m’ għandux jintuża f’ pazjenti magħrufa li jġorru l- allel HLA- B* 5701, sakemm ma jkunx hemm l- ebda għażla oħra terapewtika f’ dawn il- pazjenti, fuq bażi ta ’ trattamenti ta ’ qabel u testijiet ta ’ reżistenza (ara sezzjoni 4. 1).
3 In any patient treated with abacavir, the clinical diagnosis of suspected hypersensitivity reaction must remain the basis of clinical decision-making.
F’ kull pazjent ttrattat b’ abacavir, id- dijanjożi klinika ta ’ reazzjoni ta ’ sensittività eċċessiva suspetta għandha tibqa il- bażi tad- deċiżjoni klinika.
Therefore, even in the absence of HLA-B*5701 allele, it is important to permanently discontinue abacavir and not rechallenge with abacavir if a hypersensitivity reaction cannot be ruled out on clinical grounds, due to the potential for a severe or even fatal reaction.
Għalhekk, anke fl- assenza ta 'l- allel HLA- B* 5701, huwa mportanti li twaqqaf abacavir għal kollox u ma terġax tibdieh jekk reazzjoni ta ’ sensittività eċċessiva ma ’ tistax tiġi eskluża fuq bażi kliniku, minħabba il- possibilita' ta 'reazzjoni serja jew inkella anke fatali.
Hypersensitivity reactions are characterised by the appearance of symptoms indicating multi-organ system involvement.
Reazzjonijiet ta 'sensittivita' eċċessiva huma karatterizzati bid- dehra ta 'sintomi li jindikaw involviment ta' sistema multi- organika.
Almost all hypersensitivity reactions will have fever and/ or rash as part of the syndrome.
Kważi r- reazzjonijiet kollha ta 'sensittivita' eċċessiva ikollhom deni u/ jew raxx bħala parti mis- sindromu.
Other signs and symptoms may include respiratory signs and symptoms such as dyspnoea, sore throat, cough, and abnormal chest x-ray findings (predominantly infiltrates, which can be localised), gastrointestinal symptoms, such as nausea, vomiting, diarrhoea, or abdominal pain, and may lead to misdiagnosis of hypersensitivity as respiratory disease (pneumonia, bronchitis, pharyngitis), or gastroenteritis.
Sinjali jew sintomi frekwenti oħra ta ’ reazzjoni ta 'sensittivita'
Other frequently observed signs or symptoms of the hypersensitivity reaction may include lethargy or malaise and musculoskeletal symptoms (myalgia, rarely myolysis, arthralgia).
eċċessiva jistgħu jinkludu letarġija jew telqa u sintomi muskuloskeletali (uġigħ fil- muskoli, myolysis, arthralgia).
The symptoms related to this hypersensitivity reaction worsen with continued therapy and can be life- threatening.
Is- sintomi relatati ma 'din ir- reazzjoni ta' sensittivita 'eċċessiva jiħżienu meta tibqa' tingħata t- terapija u jistgħu iwasslu għall- mewt.
These symptoms usually resolve upon discontinuation of abacavir.
Pazjenti b' dijanjosi ta 'reazzjoni ta' sensittivita 'eċċessiva waqt it- terapija BILFORS iridu jwaqqfu Trizivir immedjatament.