qanastek/EMEA-V3 huggingface dataset:
Neither abacavir, lamivudine nor zidovudine is mutagenic in bacterial tests, but like many nucleoside analogues they show activity in the in vitro mammalian tests such as the mouse lymphoma assay.
La abacavir, la lamivudine u l- anqas zidovudine m' huma mutaġeniċi f' testijiet ta 'batterji, biss bħal ħafna analogi nukleosidi juru attivita' f' testijiet mammali in vitro bħall- analiżi ta 'limfoma fil- ġurdien.
This is consistent with the known activity of other nucleoside analogues.
Dan huwa konsistenti ma 'l- attivita' ta 'analogi nukleosidi oħra.
Lamivudine has not shown any genotoxic activity in the in vivo studies at doses that gave plasma concentrations up to 40 - 50 times higher than clinical plasma levels.
Lamivudine ma weriex xi attivita 'ġenotossika fl- istudji in vivo f' dożi b' konċentrazzjonijiet ta' plażma 4— 50 darba aktar għolja mil- livelli kliniċi ta 'plażma.
Zidovudine showed clastogenic effects in oral repeated dose micronucleus tests in mice and rats.
Zidovudine were effetti klastoġeniċi f' testijiet ta 'dożi ripetuti ta' mikronuklei fi ġrieden u firien.
Peripheral blood lymphocytes from AIDS patients receiving zidovudine treatment have also been observed to contain higher numbers of chromosome breakages.
20 jkunu fuq kura ta 'zidovudine ġew ukoll osservati li jkun fihom numri akbar ta' ksur ta 'kromożomi.
A pilot study has demonstrated that zidovudine is incorporated into leukocyte nuclear DNA of adults, including pregnant women, taking zidovudine as treatment for HIV-1 infection, or for the prevention of mother to child viral transmission.
Studju bi prova wera li zidovudine jiġi nkorporat fid- DNA nukleari ta 'lewkoċiti f' adulti. inklużi nisa tqal, li jkunu qed jieħdu zidovudine għall- kura ta' l- infezzjoni HIV- 1, jew biex il- virus ma jitħalliex jgħaddi mill- omm għall- wild.
A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at human- equivalent exposures.
Studju dwar il- ġenotossiċita 'ta' ġol- plaċenta f' xadini qabbel zidovudine waħdu ma 'taħlita ta' zidovudine u lamivudine f' esponimenti ekwivalenti fil- bniedem.
The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue-DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
L- istudju wera li feti esposti in utero għat- taħlita spiċċaw b' livell ogħla ta 'analogi nukleosidi- inkorporazzjoni ta' DNA f' organi multipli tal- feti, u wera sinjali ta 'aktar tqassir ta' telomere minn dawk esposti biss għal zidovudine.
Abacavir has a weak potential to cause chromosomal damage both in vitro and in vivo at high test concentrations and therefore any potential risk to man must be balanced against the expected benefits of treatment.
Abacavir għandu potenzjal baxx li jikkawża ħsara fil- kromożomi kemm in vitro u kemm in vivo f' konċentrazzjonijiet għolja ta 'testjar u għalhekk kull riskju li jista' jkun hemm għall- bniedem irid jitqies mall- benefiċċji tal- kura mistennija.
The carcinogenic potential of a combination of abacavir, lamivudine and zidovudine has not been tested.
Il- potenzjal karċinoġeniku ta 'abacavir, lamivudine u zidovudine flimkien għad ma ġiex ittestjat.
In oral carcinogenicity studies with zidovudine in mice and rats, late appearing vaginal epithelial tumours were observed.
Fi studji mill- ħalq fit- tul dwar karċinoġeniċita 'b’ zidovudine fi ġrieden u firien, ġew osservati tumuri epiteljali fil- vaġina li damu ma' jidhru.
A subsequent intravaginal carcinogenicity study confirmed the hypothesis that the vaginal tumours were the result of long term local exposure of the rodent vaginal epithelium to high concentrations of unmetabolised zidovudine in urine.
Studju ta 'karċinoġenecita' ta 'ġol- vaġina li sar wara ikkonferma l- ipoteżi li t- tumuri fil- vaġina kienu riżultat ta' esponiment fit- tul ta 'l- epitelju tal- vaġina tal- ġrieden għal konċentrazzjonijiet għolja ta' zidovudine mhux metabolizzat fl- awrina.
There were no other zidovudine-related tumours observed in either sex of either species.
Ma ġewx osservat tumuri oħra konnessi ma ’ zidovudine f' xi wieħed miż- żewġ sessi ta 'l- ispeċi.
In addition, two transplacental carcinogenicity studies have been conducted in mice.
Barra minn hekk, saru żewġ studji dwar karċinoġeniċita 'minn ġol- plaċenta fil- ġrieden.
One year postnatally, there was an increase in the incidence of tumours in the lung, liver and female reproductive tract of offspring exposed to the highest dose level (420 mg/ kg term body weight).
Sena wara t- twelid, kien hemm żieda fl - inċidenza ta 'tumuri fil- pulmun, fil- fwied u fil- passaġġ riproduttiv femminili tal- wild li kienu esposti għall- ogħla livell ta' doża (420 mg/ kg piż tal- ġisem f' perjodu).
In a second study, mice were administered zidovudine at doses up to 40 mg/ kg for 24 months, with exposure beginning prenatally on gestation day 10.
Fit- tieni studju, il- ġrieden ingħataw dożi sa 40 mg/ kg għal 24 xahar, b' esponiment li jkun beda qabel it- twelid fl- għaxar jum ta 'ġestazzjoni.
Treatment related findings were limited to late- occurring vaginal epithelial tumours, which were seen with a similar incidence and time of onset as in the standard oral carcinogenicity study.
Sejbiet relatati mall- kura kienu limitati għal tumuri epiteljali tal- vaġina li jseħħu wara żmien, li kienu dehru simili għall- inċidenza u ż- żmien ta 'l- okkorrenza għal dawk li ħarġu mill- istudju normali mill- ħalq dwar karċinoġeneċita'.
The second study thus provided no evidence that zidovudine acts as a transplacental carcinogen.
It- tieni studju għalhekk ma ta l - ebda sinjali li zidovudine jaġixxi bħala karċinoġen ta 'ġol- plaċenta.
It is concluded that as the increase in incidence of tumours in the first transplacental carcinogenicity study represents a hypothetical risk, this should be balanced against the proven therapeutic benefit.
Ġie għalhekk konkluż li billi ż- żieda fl- inċidenza ta 'tumuri fl- ewwel studju dwar karċinoġeniċita' ġol - plaċenta jirrappreżenta riskju ipotetiku, dan għandu jitqies mal- benefiċċju terapewtiku li ġie ppruvat.
Carcinogenicity studies with orally administered abacavir in mice and rats showed an increase in the incidence of malignant and non-malignant tumours.
Studji dwar karċinoġeniċita 'bl- għoti ta' abacavir lil ġrieden u firien wera żieda fl- inċidenza ta 'tumuri malinni u mhux malinni.
Malignant tumours occurred in the preputial gland of males and the clitoral gland of females of both species, and in rats in the thyroid gland of males and and in the liver, urinary bladder, lymph nodes and the subcutis of females.
Tumuri malinni tfaċċaw fil- glandola tal- prepuzju ta 'l- irġiel u fil- glandola tal - klitoride tan- nisa ta' l- ispeċi, u fil- firien fil- glandola tat- tirojde fl- irġiel u fil- fwied, borża ta 'l- awrina, għoqod limfatiċi u taħt il- ġilda ta' l- epidermi fin- nisa.
21 The majority of these tumours occurred at the highest abacavir dose of 330 mg/ kg/ day in mice and 600 mg/ kg/ day in rats.
Il- biċċa l- kbira ta 'dawn it- tumuri seħħew meta ngħatat l- ogħla doża ta' 330 mg/ kg/ kuljum ta 'abacavir lill- ġrieden u ta' 600 mg/ kg/ kuljum lill- firien.
The exception was the preputial gland tumour which occurred at a dose of 110 mg/ kg in mice.
L- eċċezzjoni kien it- tumur fil- glandola tal- prepuzju li seħħ meta ingħatat doża ta '110 mg/ kg lill- ġrieden.
The systemic exposure at the no effect level in mice and rats was equivalent to 3 and 7 times the human systemic exposure during therapy.
L- esponiment sistemiku f' livell ta 'bla effett fi ġrieden u firien kien ekwivalenti għal minn 3 sa 7 darbiet ta' esponiment sistemiku fil- bniedem waqt terapija.
While the carcinogenic potential in humans is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
Waqt li l- potenzjal karċinoġenu fil- bniedem mhux magħruf, dawn id- data jindikaw li r- riskju karċinoġenu għall- bniedem mhuwiex daqs il- potenzjal ta 'benefiċċji kliniċi.
Repeat-dose toxicity:
Tossiċita 'minn dożi ripetuti:
In toxicology studies abacavir was shown to increase liver weights in rats and monkeys.
Fi studji tossikoloġiċi abacavir wera li jżid il- piż tal- fwied f' xadini u firien.
The clinical relevance of this is unknown.
Ir- rilevanza klinika ta 'dan mhix magħrufa.
There is no evidence from clinical studies that abacavir is hepatotoxic.
M' hemm l- ebda sinjali minn studji kliniċi li abacavir hu tossiku għall- fwied.
Additionally, autoinduction of abacavir metabolism or induction of the metabolism of other medicinal products hepatically metabolised has not been observed in man.
Barra hekk, l- awtoinduzzjoni ta 'metaboliżmu ta' abacavir u l- induzzjoni tal- metaboliżmu ta 'prodotti mediċinali oħra li jkunu metabolizzati fil- fwied ma ġewx osservati fil- bniedem.
Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Ġiet osservata deġenerazzjoni mijokardjali fil- qalb ta 'ġrieden u firien wara li jkunu ħadu abacavir għal sentejn.
The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans.
L- esponimenti sistemiċi kienu ekwivalenti għal minn 7 sa 24 darba ta 'l- esponiment sistemiku
The clinical relevance of this finding has not been determined.
Ir- rilevanza klinika ta 'din is- sejba ma ġietx determinata.
Reproductive toxicology
Tossikoloġija riproduttiva:
Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in the rabbit at relatively low systemic exposures, comparable to those achieved in humans.
Lamivudine ma kienx teratoġeniku fi studji fuq annimali iżda kien hemm indikazzjonijiet ta 'żieda fl - imwiet embrjoniċi fil- fniek b' esponimenti sistemiċi relattivament baxxi, meta mqabbla ma' dawk li jilħaq il- bniedem.
A similar effect was not seen in rats even at very high systemic exposure.
Effett bħalu ma deherx fil- ġrieden anki meta l- esponiment sistemiku kien għoli ħafna.
Zidovudine had a similar effect in both species, but only at very high systemic exposures.
Zidovudine kellu l- istess effett fiż- żewġ speċi, iżda biss b' esponimenti sistemiċi għolja ħafna.
At maternally toxic doses, zidovudine given to rats during organogenesis resulted in an increased incidence of malformations, but no evidence of foetal abnormalities was observed at lower doses.
F' dożi tossiċi f' maternita ', zidovudine mogħti lil ġrieden waqt organogenesis irriżulta f' żieda ta' inċidenza ta 'deformazzjonijiet, iżda ma' dehrux sinjali ta 'anormalitajiet fil- fetu meta ngħataw dożi iżgħar.
Abacavir demonstrated toxicity to the developing embryo and foetus in rats, but not in rabbits.
Abacavir wera tossiċita 'waqt l- iżvilupp ta' l- embrju u l- fetu f' firien, iżda mhux fi fniek.
These findings included decreased foetal body weight, foetal oedema, and an increase in skeletal variations/ malformations, early intra-uterine deaths and still births.
Dawn is - sejbiet kienu jinkludu nuqqas ta 'piż tal- fetu, edema tal- fetu, u żieda fil- varjazzjonijiet skeletali/ deformazzjonijiet, imwiet kmieni fl- utru u twelid ta' wild mejjet.
No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Ma tistax tinġibed konklużjoni dwar il- potenzjal teratoġeniku ta 'abacavir minħabba din it- tossiċita' embrijo- fetali.
A fertility study in the rat has shown that abacavir had no effect on male or female fertility.
Studju dwar fertilita 'fil- ġurdien wera li abacavir ma kellu ebda efett fuq il- fertilita' tar- raġel jew tal - mara.
Likewise, neither lamivudine nor zidovudine had any effect on fertility.
Bl- istess mod, la lamivudine u l- anqas zidovudine ma kellhom xi effett fuq fertilita '.
Zidovudine has not been shown to affect the number of sperm, sperm morphology and motility in man.
Zidovudine ma deherx li kellu xi effett fuq in- numri fl- isperma, fuq il- morfoloġija u l- motilita 'ta' l- isperma fil - bniedem.
Core: microcrystalline cellulose, sodium starch glycollate (type A), magnesium stearate.
Fil- qalba: microcrystalline cellulose, sodium starch glycollate (type A), magnesium stearate.
Coating:
Kisi:
Opadry Green 03B11434 containing: hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.
Opadry Green 03B11434 containing: hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.
22 2 years
Sentejn
Do not store above 30°C
Taħżnux f' temperatura ’ l fuq minn 300C
Trizivir tablets are available in opaque PVC/ Aclar blister packs containing 60 tablets or child-resistant HDPE bottles containing 60 tablets.
Il- pilloli ta ’ Trizivir ikunu f' pakketti b' folji opaki tal- PVC/ Aclar li jkun fihom 40 jew 60 pillola jew fi fliexken HDPE li ma jistgħux jinfetħu minn tfal u li jkun fihom 60 pillola.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għall- immaniġġar ieħor
Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom
EU/ 1/ 00/ 156/ 002 - Blister pack (60 Tablets) EU/ 1/ 00/ 156/ 003 -Bottle pack (60 Tablets)
EU/ 1/ 00/ 156/ 002 – Pakketti b' folji (60 Pillola) EU/ 1/ 00/ 156/ 003 – Pakketti b' folji (60 Pillola)
28 December 2000
28 ta 'Diċembru 2000
Date of renewal:
Data ta ’ tiġdid:
28 December 2005
28 ta ’ Diċembru 2005
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni ddettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Agenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu / >
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur responsabbli mill- ħruġ tal- lott
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, UK
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, UK
London SW8 5 NQ.
L- Awtorizzazzjoni tal- Manifattura maħruġa fit- 30 ta ’ Ġunju 1995 mill- Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONIJIET GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L - UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (Ara anness I:
The Marketing Authorisation Holder will continue to submit periodic safety update reports and safety information related to updates on activities and investigations on the mechanisms of hypersensitivity reaction to abacavir at six-monthly intervals.
Id- detentur ta ’ l- awtorizzazzjoni ghat- tqegħid fis- suq ikompli jissottometti PSUR u informazzjoni ta ’ sigurta ’ li għandha x’ taqsam ma ’ aġġornamenti fuq attivitajiet u investigazzjonijiet fuq il- mekkaniżmi ta ’ reazzjoni ta ’ sensitivita ’ eċċessiva għal abacavir f’ intervalli ta ’ sitt xhur.
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKETT TA 'BARRA
BLISTER CARTON x 60 FILM-COATED TABLETS
PAKKETT B' FOLJI x 60 PILLOLA MIKSIJIN B’ RITA
Trizivir 300 mg/ 150 mg/ 300 mg film-coated tablets abacavir/ lamivudine/ zidovudine
Trizivir 300mg/ 150mg/ 300mg pilloli miksijin b’ rita abacavir/ lamivudine/ zidovudine
Each film-coated tablet contains: abacavir 300 mg (as sulfate) lamivudine 150 mg zidovudine 300 mg
300 mg abacavir (bħala sulfate) 150 mg lamivudine 300 mg zidovudine
Keep out of the reach and sight of children.
Żommu fejn tfal ma jilħquhx u ma jarawhx
Detach enclosed Alert Card, it contains important safety information
Aqta 'l- Karta ta ’ Twissija li hawn mal- fuljett; li fiha tagħrif importanti dwar is- sigurta'
In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY.
Jekk jidhru xi sintomi li jindikaw xi reazzjonijiet ta 'sensittivita' eċċessiva, kellem lit- tabib tiegħek MILL- EWWEL.
“ Pull here” (with Alert card attached)
“ iġbed hawn "(imwaħħal mal- Karta ta ’ Twissija)
Do not store above 30°C
Taħżinx f' temperatura ’ l fuq minn 300C
Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Greenford Middlesex UB6 0NN Ir- Renju Unit.
29 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER x 60 FILM-COATED TABLETS
FOLJA x 60 PILLOLA MIKSIJIN B’ RITA
Trizivir 300 mg/ 150 mg/ 300 mg tablets abacavir/ lamivudine/ zidovudine
Trizivir 300mg/ 150mg/ 300mg pilloli abacavir/ lamivudine/ zidovudine
BOTTLE CARTON x 60 FILM COATED TABLETS
KARTUNA TAL- FLIXKUN x 60 PILLOLI MIKSIJIN B’ RITA
EU/ 1/ 00/ 156/ 003
EU/ 1/ 00/ 156 // 003
INSTRUCTIONS ON USE
TAGĦRIF TA 'KIF GĦANDU JINTUŻA
BOTTLE LABEL x 60 FILM-COATED TABLETS
TIKKETTA TAL- FLIXKUN x 60 PILLOLI MIKSIJIN B’ RITA
34 TRIZIVIR TABLETS ALERT CARD (blister and bottle pack)
34 KARTA TA ’ TWISSIJA DWAR IL- PILLOLLI TRIZIVIR( folja u pakkett tal- flixkun)
IMPORTANT - ALERT CARD TRIZIVIR (abacavir sulfate / lamivudine / zidovudine) Tablets Carry this card with you at all times
IMPORTANTI - KARTA TA ’ TWISSIJA PILLOLI TRIZIVIR (abacavir sulfate/ lamivudine/ zidovudine) Dejjem ġorr dal- biljett miegħek
Since Trizivir contains abacavir (Ziagen) some patients taking Trizivir may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Trizivir is continued.
Billi Trizivir fih labacavir (Ziagen) xi pazjenti li jkunu qed jieħdu Trizivir jistgħu jiżviluppaw reazzjoni ta 'sensittivita' eċċessiva (reazzjoni allerġika serja) li tista 'tkun ta' periklu għall- ħajja jekk Trizivir jibqa 'jitieħed.
CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Trizivir if:
KELLEM LIT- TABIB TIEGĦEK MILL- EWWEL biex jgħidlek għandekx twaqqaf Trizivir jekk:
1) you get a skin rash OR 2) you get one or more symptoms from at least TWO of the following groups
1) joħroġlok raxx fil- ġilda JEW 2) jitfaċċalek sintomu jew aktar għall- inqas minn TNEJN mill- gruppi li ġejjin
- shortness of breath, sore throat or cough
deni
- nausea or vomiting or diarrhoea or abdominal pain
- - -
- severe tiredness or achiness or generally feeling ill
qtugħ ta 'nifs, ħruq fil- ġrieżem jew sogħla tqallih jew rimettar jew dijarea jew uġigħ addominali għeja kbira jew uġigħ mal- ġisem kollu jew ma tħossokx tiflaħ
If you have discontinued Trizivir due to this reaction, YOU MUST NEVER TAKE Trizivir, or any medicine containing abacavir (Kivexa, Ziagen) again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Jekk waqqaft Trizivir minħabba din ir- reazzjoni, QATT M' GĦANDEK TERĠA 'TIEĦU TRIZIVIR, jew xi mediċina li jkun fiha l- abacavir (Ziagen) għax tista' fi ftit siegħat titbaxxilek il - pressjoni tad- demm b' mod li ħajtek tkun fil- periklu jew li tikkaġunalek il- mewt.
(see reverse of card)
(ara wara tal- karta)
SIDE 2
FAĊĊATA TA 'WARA
You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Trizivir.
Kellem mill- ewwel lit- tabib tiegħek jekk tħoss li għandek xi reazzjoni ta 'sensittivita' eċċessiva għal Trizivir.
Write your doctor's details below:
Ikteb id- dettalji tat- tabib hawn taħt:
Doctor:...................... .……………………………………………
Tabib: ………………………………………….
Tel:.................. .…………………………………………
Tel: ……………………….
If your doctor is not available, you must urgently seek alternative medical advice (e. g. the emergency unit of the nearest hospital).
Jekk ma ssibx it- tabib tiegħek, għandek tfittex parir mediku b' urġenza (eż. id- dipartiment ta 'l - emerġenza fl- eqreb sptar.
For general Trizivir information enquiries, contact (local company name and telephone number inserted here)
Għal tagħrif ġenerali dwar Trizivir ikkuntattja (hawn jinkitbu isem il- kumpanija lokali u n- numru tat - telefon)
36 PACKAGE LEAFLET:
36 FULJETT TA 'TAGĦRIF:
INFORMATION FOR USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU
- If you have any further questions ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek..
- This medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija lilek..
Do not pass it on to others.
Tista 'tagħmlilhom
if their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħall- tiegħek.
HYPERSENSITIVITY REACTION
REAZZJONI TA 'SENSITTIVITA' EĊĊESSIVA
Since Trizivir contains abacavir (which is also the active substance of Ziagen) some patients taking Trizivir may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if you continue to take Trizivir.
Billi Trizivir fih abacavir (li hu wkoll is- sustanza attiva ta ’ Ziagen) xi pazjenti li jkunu qed jieħdu Trizivir jistgħu jiżviluppaw reazzjoni ta 'sensittivita' eċċessiva (reazzjoni allerġika serja) li tista 'tkun ta' periklu għall- ħajja jekk Trizivir jibqa 'jitieħed.
It is essential you read the information on this reaction in the “ Take special care with” section of this leaflet.
Huwa essenzjali li taqra t- tagħrif dwar din ir - reazzjoni fit- taqsima ” Oqgħod attent ħafna b ’ ” ta 'dan il- fuljett.
There is also an Alert Card included in the Trizivir pack, to remind you and medical staff about Trizivir hypersensitivity.
Hemm ukoll Karta ta 'Twissija fil - pakkett ta ’ Trizivir, biex tfakkar lilek u lil persunal mediku dwar ir- reazzjoni ta' sensittivita 'eċċessiva għal Trizivir.
This card should be removed and kept with you at all times.
Din il- karta għandek tneħħiha mill- pakkett u żżomma dejjem fuqek.
1) 2)
- deni
you get a skin rash OR you get one or more symptoms from at least TWO of the following groups - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal pain - severe tiredness or achiness or generally feeling ill
- qtugħ ta 'nifs, ħruq fil- ġrieżem jew sogħla
If you have discontinued Trizivir due to a hypersensitivity reaction, YOU MUST NEVER TAKE Trizivir, or any other medicine containing abacavir (i. e.
- dardir jew rimettar jew dijareja jew uġigħ addominali
Kivexa, Ziagen) again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Jekk waqqaft Trizivir minħabba xi reazzjoni ta 'sensittivita' eċċessiva, QATT M' GĦANDEK TERĠA 'TIEĦU TRIZIVIR, jew xi mediċina li jkun fiha abacavir (i. e. Kixeva, Ziagen) għax tista' fi ftit siegħat titbaxxilek il- pressjoni tad- demm b' mod li ħajtek tkun fil- periklu jew li tikkaġunalek il - mewt.
If you are hypersensitive to Trizivir you should return all of your unused Trizivir tablets for disposal.
Jekk għandek xi sensittivita 'eċċessiva għal Trizivir għandek tieħu lura l- pilloli kollha ta ’ Trizivir biex jintremew.
What Trizivir is and what it is used for 2.
X' inhu Trizivir u għalxiex jintuża 2.
Before you take Trizivir 3.
Qabel ma tieħu Trizivir 3.
How to take Trizivir 4.
Kif għandek tieħu Trizivir 4.
How to store Trizivir 6.
Kif taħżen Trizivir 6.
WHAT TRIZIVIR IS AND WHAT IT IS USED FOR
X' INHU TRIZIVIR U GĦALXIEX JINTUŻA
Trizivir contains abacavir, lamivudine and zidovudine.
Trizivir fih abacavir, lamivudine u zidovudine.
All of these belong to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), which are used to treat Human Immunodeficiency Virus (HIV) infection.
Dawn kollha jiffurmaw parti mill- grupp ta 'mediċini li jissejħu nucleoside analogue reverse transcriptase inhibitors (NRTIs), li jintużaw fil- kura ta' l - infezzjoni bil- Virus ta 'l- Immunodefiċjenza Umana (HIV).
These three medicines can be used separately with other medicines for combination treatment of HIV infection, or can be used together.
Dawn it- tliet mediċini jistgħu jintużaw separatament ma 'mediċini oħra f' kura kombinata ta' l- infezzjoni HIV, jew jistgħu jintużaw flimkien.
The dose of each active ingredient in Trizivir is the same as that recommended for the medicines when used separately.
Id- doża ta 'kull sustanza attiva f’ Trizivir hi l- istess bħal dik rakkomandata għall- mediċini meta wżati
37 low level.
37 flimkien.
It also increases CD4 cell counts.
Iżid ukoll l- għadd ta 'ċelluli CD4.
CD4 cells are a type of white blood cell that play an important role in maintaining a healthy immune system to help fight infection.
Iċ- ċelluli CD4 huma tip ta 'ċelluli bojod fid- demm li huma importanti biex iżommu sistema immuni tajba fil- ġlieda kontra l- infezzjoni.
Response to treatment with Trizivir varies between patients.
Ir- reazzjoni għall- kura b’ Trizivir tvarja bejn pazjent u ieħor.
Your doctor will be monitoring the effectiveness of your treatment.
It- tabib tiegħek jimmonitorja l- effett ta 'din il- mediċina.
BEFORE YOU TAKE TRIZIVIR
QABEL MA TIEĦU TRIZIVIR
Do not take Trizivir
Tieħux Trizivir:
- if you have previously suffered an allergic reaction to Trizivir or any other medicine containing
- jekk kont tbati minn xi reazzjoni allerġika għal Trizivir jew għal xi mediċina oħra li jkun
abacavir (Kivexa, Ziagen), lamivudine or zidovudine, or any of the other ingredients found in Trizivir
fiha abacavir (Ziagen), lamivudine jew zidovudine, jew xi sustanzi oħra li jinsabu f’ Trizivir
- if you have liver disease
- jekk għandek xi disturbi fil- fwied
- if you have severe kidney disease
- jekk għandek xi disturbi serju fil- kliewi
- if you have a very low red blood cell count (anaemia) or very low white blood cell count
- jekk għandek għadd baxx ħafna ta 'ċelluli tad- demm ħomor (anemija) jew għadd baxx
(neutropenia).
ħafna ta 'ċelluli tad- demm bojod (newtropenja).
If you are not sure about any of these please consult your doctor.
Jekk m' intix ċert dwar dawn l- affarijiet kellem lit- tabib tiegħek.
Take special care with Trizivir
Oqgħod attent ħafna bi Trizivir
Hypersensitivity reaction (serious allergic reaction):
Reazzjoni ta 'sensittivita' eċċessiva (reazzjoni allerġika serja):
About 5 in every 100 patients, who are treated with abacavir, develop a hypersensitivity reaction.
Madwar 4 minn kull 100 pazjent li jieħdu abacavir jiżviluppaw reazzjoni ta 'sensittiva' eċċessiva.
The most common symptoms of this reaction are high temperature (fever) and a skin rash.
L- aktar sintomi komuni ta 'din ir- reazzjoni huma deni għoli u raxx tal- ġilda.
Other frequently observed signs are nausea, vomiting, diarrhoea, abdominal pain and severe tiredness.
Sinjali oħra huma dardir, rimettar, dijareja, uġigħ ta 'żaqq u għeja kbira.
Other symptoms may include joint or muscle pain, swelling of the neck, shortness of breath, sore throat, cough and headache.
Sintomi oħra jinkludu uġigħ fil- ġogi jew fil- muskoli, nefħa fl- għonq, qtugħ ta 'nifs, ħruq fil- grieżem, sogħla, uġigħ ta' ras.
Occasionally inflammation of the eye (conjunctivitis), mouth ulcers or low blood pressure may occur.
Kultant jista 'jkun hemm ukoll infjammazzjoni fl- għajnejn (konġuntivite), ulċeri fil- ħalq jew pressjoni tad- demm baxxa.
The symptoms of this allergic reaction can occur at any time during treatment with abacavir.
Is- sintomi ta 'din ir- reazzjoni allerġika jistgħu jitfaċċaw fl- ewwel sitt ġimgħat tal- kura.
The symptoms worsen with continued treatment and may be life-threatening if treatment is continued.
Is- sintomi jiħżienu meta tibqa 'tingħata l- kura u jekk ma titwaqqafx dan jista' jkun ta 'periklu għall- ħajja u jista' wkoll iwassal għall- mewt
1) you get a skin rash OR 2) you get one or more symptoms from at least TWO of the following groups
1. joħroġlok raxx fil- ġilda JEW 2. jitfaċċalek sintomu jew sintomi li jidhru għall- inqas fi TNEJN mill- gruppi li ġejjin
- shortness of breath, sore throat or cough
- qtugħ ta 'nifs, ħruq fil- ġrieżem jew sogħla
- nausea or vomiting or diarrhoea or abdominal pain
- dardir jew rimettar jew dijareja jew ma tħossokx tiflaħ
- severe tiredness or achiness or generally feeling ill
- għeja kbira jew uġigħat jew tħossok mitluq
If you have discontinued Trizivir due to a hypersensitivity reaction, YOU MUST NEVER TAKE Trizivir or any other medicine containing abacavir (i. e.
Jekk waqqaft Trizivir minħabba xi reazzjoni ta 'sensittivita' eċċessiva, QATT M' GĦANDEK TERĠA 'TIEĦU TRIZIVIR, jew xi mediċina li jkun fiha abacavir (i. e.
Kivexa, Ziagen) again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Kixeva, Ziagen) għax tista 'fi ftit siegħat titbaxxilek il- pressjoni tad- demm b' mod li ħajtek tkun fil- periklu jew li tikkaġunalek il - mewt.
If you have stopped taking Trizivir for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting.
38 Jekk għal xi raġuni waqqaft Trizivir, partikolarment għax ħassejt li qed ikollok xi effetti avversi jew minħabba xi disturbi ieħor, hu importanti li tkellem lit- tabib tiegħek qabel ma terġgħa tibda tieħdu.
Your doctor will check whether any symptoms you had may be related to this hypersensitivity reaction.
It - tabib ikun jista 'jara jekk is- sintomi li kellek kellhomx x' jaqsmu mar- reazzjoni ta' sensittivita 'eċċessiva.
If your doctor thinks there is a possibility that they were related, you will be instructed never to take Trizivir
Jekk it- tabib jidhirlu li hemm il- possibilta 'li dawn kellhom x' jaqsmu, int tiġi avżat li m' għandek qatt aktar tieħu Trizivir jew xi mediċina oħra li jkun fiha abacavir (i. e.
It is important that you follow this advice.
Importanti ħafna li dan il- parir ma tiksrux.
Occasionally life-threatening hypersensitivity reactions have occurred when abacavir was restarted in patients who reported only one of the symptoms on the Alert Card before stopping.
Ġie li kien hemm reazzjonijiet ta 'sensittivita' eċċessiva ta 'periklu għall- ħajja meta pazjenti li kienu waqfu milli jieħdu abacavir minħabba sintomu wieħed biss fuq il- Karta ta' Allarm reġgħu bdew jieħdu din il- mediċina.
On very rare occasions hypersensitivity has been reported when abacavir was restarted in patients who had no symptoms of hypersensitivity before stopping.
F' xi każi rari ħafna ġiet rappurta sensittivita 'eċċessiva meta pazjenti li ma wrewx sintomi ta' sensittivita 'eċċessiva qabel waqfu, reġgħu bdew jieħdu abacavir.
If you are hypersensitive to Trizivir you should return all of your unused Trizivir tablets for disposal.
Jekk għandek sensittivita 'eċċessiva għat- Trivizir għandek tieħu lura l- pilloli kollha ta ’ Trizivir biex jintremew.
Ask your doctor or pharmacist for advice.
Staqsi lit- tabib jew spiżjar tiegħek għall- parir.
Lactic acidosis: the class of medicines to which Trizivir belongs (NRTIs) can cause a condition called lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver.
Aċidożi laktika: il- klassi ta 'mediċini li Trizivir jifforma parti minnha (NRTI) jistgħu jikkawżaw kondizzjoni jgħidulha aċidożi lattika (eċċess ta' aċidu lattiku fid- demm), flimkien ma 'tkabbir ta' fwied.
Lactic acidosis, if it occurs, usually develops after a few months of treatment.
Meta sseħħ, l- aċidożi lattika normalment tiżviluppa xi ftit xhur wara li tinbeda l- kura.
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 oħra mhux speċifiċi bħal dardir, rimettar u uġigħ fl- istonku jistgħu jindikaw l- iżvilupp ta 'aċidożi lattika.
This rare but serious side effect occurs more often in women, particularly if very overweight.
Dan l- effet ħażin, rari iżda serju, aktar jiġri f' nisa milli f' irġiel, l- iżjed meta jkunu ħoxnin.
If you have liver disease you may also be more at risk of getting this condition.
Jekk ikollok xi disturbi fil- fwied aktarx li tkun f' riskju akbar li tiżviluppa din il - kondizzjoni.
While you are being treated with Trizivir, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Waqt li tkun qed tieħi Trizivir iżommok taħt sorveljanza għal xi sinjali ta 'aċidożi lattika.
Fat redistribution: redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
Tqassim ta ’ xaħam: pazjenti li jkunu fuq terapija kombinata antiretrovirali jista 'jkollhom tqassim mill - ġdid, tiġmigħ jew tnaqqis ta' xaħam mill- ġisem.
Contact your doctor if you notice changes in body fat.
Kellem lit- tabib jekk tosserva xi tibdil fix- xaħam tal - ġisem
Liver disease/ hepatitis: please tell your doctor if you have a history of liver disease.
Disturbi tal- fwied/ epatite: jekk jogħġbok kellem lit- tabib jekk ikollok xi storja ta 'xi disturbi fil- fwied.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.
Pazjenti bl- epatite B jew C li jkunu qed jiġu kkurati b' agenti antiretrovirali qegħdin f' riskju akbar ta 'xi effetti fil- fwied li jkunu serji, u jistgħu anki jkunu fatali, u jistgħu jiġu bżonn ta' testijiet tad- demm biex jimmonitorjaw il- funzjonament tal- fwied tagħhom.
If you have hepatitis B infection, you should not stop your Trizivir without instructions from your doctor, as you may have a recurrence of your hepatitis.
Jekk għandek l- infezzjoni ta 'l- epatite B, m' għandekx twaqqaf Trizivir bla ma tgħid lit- tabib tiegħek, għax tista' terġgħa titfaċċalek l- epatite.
This recurrence may be more severe if you have serious liver disease.
Din id- darba tista 'tkun serja aktar minħabba li għandek disturbi fil- fwied.
Pancreatitis: inflammation of the pancreas (pancreatitis) has been reported in some patients treated with lamivudine and zidovudine, although it was not clear whether this was due to the medicine or the HIV infection itself.
Pankrejate: infjammazzjoni tal- frixa (pankreatite) ġrat f' xi ftit pazjenti li kienu qed jieħdu lamivudine u zidovudine, iżda qatt ma deher ċar jekk dan kienx riżultat tal- mediċina jew ta 'l- infezzjoni ta' l- istess marda.
If your doctor detects clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis they will stop treatment with Trizivir immediately.
Jekk it- tabib josserva xi sinjali, sintomi jew anormalitajiet kliniċi li jindikaw pankreatite dan iwaqqaflek Trizivir immedjatament.
Anaemia and neutropenia: zidovudine can reduce the number of red blood cells, resulting in anaemia.
Anemija u newtropenija: zidovudine jista 'jkollu effett fuq il- produzzjoni taċ- ċelluli tad- demm ħomor, li jirriżulta f' anemija.
If this happens, the symptoms are tiredness and shortness of breath.
Jekk jiġri dan, is- sintomi jkunu għeja u qtugħ ta 'nifs.
Less commonly, the production of a certain type of white blood cell may be reduced (neutropenia) which can make you more prone to infections.
Mhux daqshekk komuni, il- produzzjoni ta 'ċerti tipi ta' ċelluli tad- demm bojod tista tonqos u dan jista jissuġġettak għal infezzjonijiet.
Your doctor may want you to have a blood test from time to time to check the blood cell count.
It- tabib għandu mnejn jagħmillek testijiet tad- demm minn żmien għal ieħor biex jiċċekkja l- għadd ta 'ċelluli fid- demm.
These effects are generally reversible.
Dawn l- effetti ġeneralment ikunu jistgħu jitreġġgħu lura.
Please contact your doctor if you notice symptoms of anaemia.
Jekk jogħġbok ikkuntatja lit- tabib tiegħek jekk tinnota sintomi ta ’ anemija.
Your doctor will advise you whether you should stop taking Trizivir.
It- tabib tiegħek jagħtik parir fuq jekk għandekx tieqaf tieħu Trizivir.
Immune Reactivation Syndrome: in some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Jemmnu li dawn is- sintomi jiġru
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
39 minħabba li is- sistema immunitarja tal- ġisem tmur għall- aħjar u b’ hekk il- ġisem ikun aktar kapaċi jiġġieled l- infezzjonijiet li setgħu kienu hemm qabel mingħajr ma kienu qed jagħtu sintomi ovvji.
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe
Xi pazjenti li jieħdu t- terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta ’ l- għadam li tissejjaħ ostejonekrożi (mewt tas- sustanza ta ’ l- għadma minħabba nuqqas ta ’ ċirkolazzjoni lejn l- għadma).
39 immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul tat- terapija antiretrovirali kombinata, l- użu ta ’ kortikosterojdi, il - konsum ta ’ alkoħol, trażżin immunitarju sever, body mass index aktar għoli, fost l- oħrajn, jistgħu ikunu xi wħud mill- fatturi ta ’ riskju biex tiżviluppa din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ ostejonekrożi huma egħbusija tal- ġogi, uġigħ (speċjalment tal- koxxa, l- irkoppa u l- ispalla) u diffikulta ’ fil- moviment.
Trizivir helps to control your condition but is not a cure for HIV infection.
Ġenerali: Trizivir jgħin biex itejjiblek il- kondizzjoni iżda ma jfejjaqlekx l- infezzjoni ta 'l- HIV.
You will need to take it every day.
Ikollok il- bżonn li tieħdu kuljum.
Do not stop taking your medicine without first talking to your doctor.
M' għandekx twaqqaf il- mediċina mingħajr l- ewwel tgħid lit- tabib.
If however, you suspect you are developing a hypersensitivity reaction (see above) contact your doctor immediately who will advise you whether you should stop taking Trizivir.
Madankollu, jekk tissuspetta li qed tiżviluppa xi reazzjoni ta 'sensittivita' eċċessiva (ara hawn fuq) kellem mill- ewwel lit- tabib biex imbagħad jgħidlek għandekx twaqqaf Trizivir.
Treatment with Trizivir has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Il- kura b’ Trizivir ma wrietx li tnaqqas ir- riskju li wieħed jgħaddi l- infezzjoni ta 'l- HIV lil xi oħrajn permezz ta' kuntatti sesswali jew b' kontaminazzjoni mid- demm.
You should continue to use appropriate precautions to prevent this.
Għandek tibqa 'tieħu l- prekawzjonijiet xierqa biex dan tevitah.
You may continue to develop other infections and other illnesses associated with HIV disease.
Tista 'tkompli tiżviluppa infezzjonijiet u disturbi ieħor assoċjat mal- marda ta' l- HIV.
You should therefore keep in regular contact with your doctor while taking Trizivir.
Għalhekk għandek iżżomm kuntatt kontinwu mat- tabib tiegħek meta tkun qed tieħu Trizivir.
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew spizjar tiegħek jekk tkun qed tieħu jew għadek kemm ħadt xi mediċini oħra, anki dawk li stajt ħadt mingħajr riċetta.
Trizivir should not be taken with stavudine, zalcitabine, injections of ganciclovir or foscarnet.
Trizivir m' għandux jittieħed ma 'istavudine, zalcitabine, injezzjonijiet ta ’ gancyclovir jew foscarnet.
Trizivir may interact with certain other medicines, which may make side effects worse.
Triżivir jista 'ma jkunx jaqbel ma' xi mediċini oħra, li jistgħu jagħmlu l- effetti aktar avversi.
It is important that you tell your doctor if you are taking any of the following medicines (ask your doctor if you are not sure).
(staqsi lit- tabib meta jkollok dubju).
- Phenytoin, sodium valproate, phenobarbital.
- Phenytoin, sodium valproate, phenobarbital
- Methadone, rifampicin, probenecid.
- Methadone, rifampicin, probenecid.
- Pentamidine, pyrimethamine, co-trimoxazole, fluconazole, dapsone, atovaquone, amphotericin,
- Pentamidine, pirimetamine, co- trimaxozole, fluconazole, dapsone, atovaquone, amphotericin,
flucytosine, interferon, clarithromycin.
flucytosine, interferon, clarithromycin.
- Vincristine, vinblastine and doxorubicin.
- Vincristine, vinblastine u doxorubicin.
Alcohol increases the amount of abacavir in your blood.
L- alkoħol ikattarlek l- ammont ta 'abacavir fid- demm.
If you are taking oral vitamin A related medicines, e. g. isotretinoin, you should inform your doctor since these may also increase the amount of abacavir in your blood.
Jekk qed tieħu mediċini mill- ħalq li għandhom x' jaqsmu mal- vitamina A e. g isotretinoin, għandek tgħid lit- tabib għax dawn ukoll jistgħu iżidulek l- ammont ta 'abacavir fid- demm.
As abacavir increases the rate at which methadone is removed from the body, patients taking methadone will be checked for any withdrawal symptoms, and may have their methadone dose changed.
Billi l- abacavir iżid ir- rata li biha jitneħħa methadone mill- ġisem, il- pazjenti fuq il- methadone ikunu iċċekjati għal sintomi ta ’ withdrawal u tista ’ tinbidlilhom id- doża tal- methadone.
Pregnancy Trizivir is not recommended for use during pregnancy.
Tqala Trizivir mhux rakkomandat għall- użu waqt it- tqala.
If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.
Jekk int tqila jew qed tippjana biex toħroġ tqila, għandek tkellem lit- tabib tiegħek biex tiddiskuti l- effetti avversi potenzjali li jistgħu jiġru u l - benefiċċji u r- riskji tat- terapija antiretrovirali fuqek u fuq it- tarbija tiegħek.
If you have taken Trizivir during your pregnancy, your doctor may request regular visits to monitor the development of your child.
Jekk tkun ħadt Trizivir waqt it- tqala, it- tabib jista ’ jirrikjedi viżti regolari biex josserva l- iżvilupp tat - tarbija tiegħek.
In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.
40 Fit- tfal li l- omm tkun ħadet in- nukleosidi u analogi tan- nukleosidi waqt it- tqala, il- benefiċċju ta ’ ċans inqas li jkunu infettati bl- HIV huwa akbar mir- riskju li jsofru minn xi effetti sekondarji.
Breast-feeding You are recommended NOT to breast-feed your baby while taking Trizivir.
Treddigħ Hu rakkomandat li M' GĦANDEKX tredda 'lit- tarbija tiegħek waqt li qed tieħu Trizivir.
Additionally it is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV from mother to child.
Barra min hekk, hu rakkomandat li, fl- ebda ċirkostanza, nisa nfettati bl- HIV m' għandhom ireddgħu lit- trabi tagħhom biex hekk jevitaw li jgħaddulhom il- marda ta 'l- HIV.
If you are breast-feeding you must inform your doctor.
Jekk qed tredda 'kellem lit- tabib.
40 Driving and using machines No studies on the effects of Trizivir on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta 'makkinarju Għad ma sarux studji dwar l- effetti ta ’ Trizivir fuq il- ħila għas- sewqan u t- tħaddim ta' makkinarju.
However, you should take into account the state of your health and the possible side effects of Trizivir before considering driving or using machines.
Madankollu, għandek iżżomm f' moħħok l- istat ta 'saħħtek u l- effetti sekondarji possibli li jista' jkollu Trizivir qabel tiddeċiedi biex issuq jew tħaddem xi makkinarju.
HOW TO TAKE TRIZIVIR
KIF GĦANDEK TIEĦU TRIZIVIR
Always take Trizivir exactly as your doctor has told you, and take great care not to miss any doses if at all possible.
Dejjem ħu Trizivir preċiżament kif jgħidlek it- tabib u ara li possibilment ma tfalli qatt milli tieħu d - dożi li jmissek.
You should check with your doctor or pharmacist if you are not sure.
Kellem lit- tabib jew spiżjar tiegħek meta ma tkunx ċert.
The usual dose in adults is one tablet twice a day.
Id- doża normali ta 'kuljum ta' Trizivir għall- kbar hi pillola waħda darbtejn kuljum.
Each tablet of Trizivir should be taken approximately 12 hours apart.
Kull pillola Trizivir għandha bejn wieħed u ieħor tittieħed f' intervalli ta '12- il siegħa.
Swallow the tablet whole with water.
Ibla 'l- pillola sħiħa bl- ilma.
Trizivir can be taken with or without food.
Il- pilloli ta ’ Trizivir jistgħu jittieħdu ma 'l- ikel jew mhux ma' l- ikel.
If your doctor wants to reduce your dose of Trizivir, for example if you have kidney problems, then your medicine may be changed to lamivudine, zidovudine and abacavir taken as separate medicines.
Jekk it- tabib ikun irid inaqqaslek id- doża ta ’ Trizivir, per eżempju jekk ikollok disturbi fil- kliewi, il - mediċina tista 'tinbidillek għal lamivudine, zidovudine u abacavir bħala mediċini separati.
If you take more Trizivir than you should If you accidentally take too much of your medicine you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Jekk tieħu Trizivir aktar milli suppost għandek Jekk aċċidentalment tieħu mediċina żejda għandek tgħid lit- tabib jew spiżjar tiegħek, jew tikkuntattja d- dipartiment ta 'l- emerġenza fi sptar fil- qrib għall- parir li tkun tinħtieġ.
If you forget to take Trizivir It is important to take the total daily dose prescribed to ensure you get maximum benefit.
Jekk tinsa tieħu t- Trizivir Hu importanti li kuljum tieħu d- doża li nkitbitlek biex tieħu l- aħjar benefiċċju mill- mediċina.
If you forget to take a dose of your medicine, take it as soon as you remember, and then continue as before.
Jekk tinsa tieħu xi doża, ħudha malli tiftakar u kompli għaddej bħal qabel.
It is important to take Trizivir regularly because irregular intake may increase the risk of hypersensitivity reactions.
Hu importnti li Trizivir tieħdu regolarment għax jekk dan ma tagħmlux jista 'jiżdiedlek ir- riskju ta' reazzjonijiet ta 'sensittivita' eċċessiva.
If you stop taking Trizivir If you have stopped taking Trizivir for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting.
Jekk għal xi raġini waqft tieħu Trizivir, partikolarment għax deherlek li għandek xi effetti avversi jew minħabba xi disturbi ieħor, hu importanti li tkellem lit- tabib qabel ma terġa 'tibda tieħdu.
In some cases your doctor will ask you to restart Trizivir in a place where you will be able to get ready access to medical care if needed.
Xi drabi t - tabib jgħid lil dak li jkun biex Trizivir jieħdu fejn jista 'malajr isib assistenza medika jekk jiġi bżonnha.
Like all medicines, Trizivir can cause side effects, although not everybody gets them.
Bħall- mediċini kollha, Trizivir jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
When treating HIV infection, it is not always possible to tell whether some of the side effects that occur are caused by Trizivir, by other medicines you are taking at the same time or by the HIV disease.
Meta tkun qed tikkura l- infezzjoni HIV, mhux dejjem possibbli tgħid li xi effetti avversi li jinħassu jkunu kawżati minn Trizivir, minn xi mediċini oħra li tkun qed tieħu fl- istess ħin jew mill- marda ta 'l- HIV.
A hypersensitivity reaction (serious allergic reaction) has been reported in about 5 in every 100 patients who have been treated with abacavir.
Reazzjoni ta 'sensittivita' eċċessiva (reazzjoni allerġika serja) giet rappurtata f' madwar 5 minn kull 100 pazjent li kienu jieħdu abacavir.
It is important that you read and understand the information about this serious reaction.
Dan jinsab deskritt fit- taqsima 2 ta 'dan il- fuljett taħt “ Oqgħod attent ħafna b’ Trizivir "Hu importanti għalik li li taqra u tifhem dan it- tagħrif dwar din ir - reazzjoni serja.
The side effects listed below have been reported with one or more of these medicines and therefore may occur also when taking Trizivir Very common side effects (reported in greater than 10 out of 100 patients)
41 Effetti sekondarji komuni ħafna (rrappurtati f’ aktar min 10 minn 100 pazjent)
− headache, nausea
- uġigħ ta ’ ras, tqallih
Common side effects (reported in 1 to 10 out of 100 patients)
Effetti sekondarji komuni (rrapurtati f’ 10 minn 100 pazjent)
− anaemia (low red blood cell count) and neutropenia / leucopenia (low white blood cell count).
- anemija (għadd baxx ta 'ċelluli tad- demm ħomor) u newtropenja / lewkopenja (għadd baxx ta'