qanastek/EMEA-V3 huggingface dataset:
In six HIV-infected children from 2 to 13 years of age, zidovudine plasma pharmacokinetics were evaluated while subjects were receiving 120 mg/ m2 zidovudine three times daily and again after switching to 180 mg/ m2 twice daily.
F’ sitt itfal ta 'bejn is- sentejn u t- 13- il sena infettati bl- HIV, il- farmakokinetika ta ’ zidovudine fil - plażma kienet evalwata meta suġġetti irċevew 120mg/ m² ta ’ zidovudine tlett darbiet kuljum u ukoll wara li qalbu għal 180mg/ m² darbtejn kuljum.
Systemic exposures (daily AUC and Cmax) in plasma from the twice daily regimen appeared equivalent to those from the same total daily dose given in three divided doses [Bergshoeff, 2004].
Espożizzjonijiet sistemiċi (AUC u C max kuljum) fil - plażma minn f’ sistema ta 'darbtejn kuljum dehret ekwivalenti għal dawk mill- istess doża totali ta ’ kuljum meta ingħatat fi tliet dożi separati [Bergshoeff, 2004].
In general, lamivudine pharmacokinetics in paediatric patients are similar to adults.
Ġeneralment, il- farmakokinetika ta ’ lamivudine f’ pazjenti pedjatriċi hija l- istess bħal ta ’ l- adulti.
However, absolute bioavailability (approximately 55-65%) was reduced in paediatric patients below 12 years of age.
Madankollu, il- biodisponibilità assoluta (bejn wieħed u ieħor 55- 65%) kienet anqas f’ pazjenti pedjatriċi taħt it- 12 - il sena.
In addition, systemic clearance values were greater in younger paediatric patients and decreased with age, approaching adult values around 12 years of age.
Barra minn hekk, valuri sistemiċi ta ’ tneħħija kienu akbar f’ pazjenti pedjatriċi iżgħar u naqsu skond l- età, biex jilħqu valuri ta ’ l- adulti madwar it- 12- il sena.
Due to these differences, the recommended dose for lamivudine in children (aged more than three months and weighing less than 30 kg) is 4 mg/ kg twice a day.
Minħabba dawn id- differenzi, id- doża rrakkomandata għal lamivudine fit- tfal (ta ’ aktar minn tlett xhur u li jiżnu anqas minn 30kg) hija ta '4mg/ kg darbtejn kuljum.
This dose will achieve an average AUC0-12 ranging from approximately 3,800 to 5,300 ng h/ ml.
Din id- doża twassal għal AUC 0- 12 bejn wieħed u ieħor minn 3, 800 sa 5, 300ng. h/ ml.
Recent findings indicate that exposure in children < 6 years of age may be reduced by about 30% compared with other age groups.
Skoperti riċenti juru li espożizzjoni fi tfal < 6 snin jistgħu jonqsu bi 30% meta mqabbla ma ’ gruppi oħrajn ta ’ eta differenti..
Further data addressing this issue are currently awaited.
Aktar data li tindirizza dan is- suġġett bħalissa hija mistennija.
At present, the available data do not suggest that lamivudine is less efficacious in this age group.
Fil- preżent, id- data disponibbli ma turix li lamivudine huwa anqas effikaċi f’ dan il - grupp ta’ età.
Pharmacokinetics in pregnancy:
13 Farmakokinetika fit- tqala:
The pharmacokinetics of lamivudine and zidovudine were similar to that of non-pregnant women.
Il- farmakokinetka ta ’ lamivudine u ta ’ zidovudine kienu l- istess bħal dawk ta 'nisa mhux tqal.
The clinically relevant effects of lamivudine and zidovudine in combination are anaemia, neutropenia and leucopenia.
L- effetti kliniċi ta ’ lamivudine u ta ’ zidovudine flimkien li huma relevanti huma anemija, newtropenja u lukopenja.
Neither lamivudine nor zidovudine are mutagenic in bacterial tests, but like many nucleoside analogues they show activity in in vitro mammalian tests such as the mouse lymphoma assay.
La lamivudine u l- anqas zidovudine ma nstabu li huma mutaġeniċi f' testijiet bil- batterji imma, bħal ħafna analogi nuklejosidi, juru attivita 'f’ testijiet in vitro fil- mammali bħal l- analiżi tal- limfoma fil - ġrieden.
Lamivudine has not shown any genotoxic activity in in vivo studies at doses that gave plasma concentrations up to 40-50 times higher than clinical plasma levels.
Lamivudine ma kienx ġenotossiku in vivo f' dożi li rriżultaw f’ konċentrazzjonijiet fil- plażma ta 'madwar 40- 50 darba aktar mil- livelli kliniċi fil- plażma.
Zidovudine showed clastogenic effects in an or al repeated dose micronucleus test in mice.
Zidovudine wera effetti klastoġeniċi f' testijiet ta 'dożi ripetuti ta' mikronuklei fil- ġrieden.
Peripheral blood lymphocytes from AIDS patients receiving zidovudine treatment have also been observed to contain higher numbers of chromosome breakages.
Limfoċiti tad- demm periferali minn pazjenti bl- AIDS li jkunu fuq kura ta 'zidovudine ġew ukoll osservati li jkun fihom numri akbar ta' ksur ta 'kromosomi.
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.
Zidovudine was also incorporated into DNA from cord blood leukocytes of infants from zidovudine-treated mothers.
Zidovudine ġie wkoll inkorporat f' DNA mill- lewkoċiti tad- demm tal - kurdun fi trabi ta 'ommijiet fuq kura ta' zidovudine.
A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at human- 13 equivalent exposures.
Studju dwar jekk il- ġenotossiċita 'taqbiżx il - 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 inkorporati ma ’ DNA f' organi multipli tal- feti, u wera sinjali ta' telomere iqsar minn dawk esposti biss għal zidovudine.
The clinical significance of these findings is unknown.
L- importanza klinika ta 'dawn is- sejbiet mhix magħrufa.
The carcinogenic potential of a combination of lamivudine and zidovudine has not been tested.
Il- potenzjal karċinoġeniku ta 'lamivudine u zidovudine flimkien għad ma ġiex ittestjat
In long-term oral carcinogenicity studies in rats and mice, lamivudine did not show any carcinogenic potential.
Fi studji fit- tul dwar karċinoġeniċita 'fil- ġrieden u fil- firien, lamivudine ma wera l- ebda potenzjal karċinoġeniku.
In oral carcinogenicity studies with zidovudine in mice and rats, late appearing vaginal epithelial tumours were observed.
Fi studji fit- tul li saru, dwar il- karċinoġeniċita 'ta ’ zidovudine meta ttieħed mill- ħalq, fi ġrieden u firien, ġew osservati tumuri epiteljali fil- vaġina li damu ma' tfettxew.
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 dwar il- karċinoġenecita 'ta' ġol- vaġina li sar wara ikkonferma l- ipotesi li t- tumuri fil- vaġina kienu r- riżultat ta 'espożizzjoni fit - tul ta' l- epitelju tal- vaġina tal- ġrieden għal konċentrazzjonijiet għolja ta 'zidovudine mhux metabolizzat li ħareġ fl- awrina.
There were no other zidovudine-related tumours observed in either sex of either species.
Ma ġewx osservati tumuri oħra relatati ma ’ zidovudine f' xi wieħed miż- żewġ sessi taż- żewġ speċi.
In addition, two transplacental carcinogenicity studies have been conducted in mice.
Barra minn hekk, saru żewġ studji dwar karċinoġeniċita 'tkunx protetta mill- plaċenta fil- ġrieden.
In one study, by the US National Cancer Institute, zidovudine was administered at maximum tolerated doses to pregnant mice from day 12 to 18 of gestation.
Fi studju minnhom, li kien sar mill- US National Cancer Institute, zidovudine ingħata fl- ogħla dożi ta 'tolleranza lil ġrieden tqal bejn it- 12 u t- 18- il jum ta' ġestazzjoni.
One year post-natally, 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 żjieda fl- inċidenza ta 'tumuri fil- pulmun, fil- fwied u fil- passaġġ riproduttiv femminili ta ’ l- ulied li kienu esposti għall- ogħla livell ta' doża (420 mg/ kg piż tal- ġisem f' perijodu).
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 zidovudine f’ dożi sa 40 mg/ kg għal 24 xahar, b' espożizzjoni li tkun bdiet 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 mal- kura kienu limitati għal tumuri epiteljali tal- vaġina li jifaċċaw wara tul ta’ żmien, li kienu dehru b’ inċidenza u bi żmien ta 'l - okkorrenza simili għal dawk li ħarġu mill- istudju standard dwar il- karċinoġeneċita' meta l- prodott jittieħed mill- ħalq.
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 għax jgħaddi mill- 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.
Fi studji dwar it- tossiċita 'riproduttiva lamivudine wera xi sinjali li jikkawża żieda ta' mwiet minn kmieni ta ’ embrjoni fil- fniek b' espożizzjonijiet sistemiċi relattivament baxxi, li jistgħu jitqabblu ma '
In reproductive toxicity studies lamivudine has demonstrated evidence of causing an increase in early embryonic deaths in the rabbit at relatively low systemic exposures, comparable to those achieved in man, but not in the rat even at very high systemic exposure.
Zidovudine kellu l- istess effett fuq iż- żewġ speċi, imma biss meta kien hemm espożizzjonijiet sistemiċi għoljin ħafna.
Zidovudine had a similar effect in both species, but only at very high systemic exposures.
Zidovudine kellu l- istess effett fuq iż- żewġ speċi, imma biss b' espożizzjonijiet sistemiċi għoljin ħafna.
Lamivudine was not teratogenic in animal studies.
Lamivudine ma kienx teratoġeniku fi studji fuq l- annimali.
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.
Meta zidovudine ingħata lil firien waqt organoġenesi f' dożi li huma tossiċi għall- omm, dan irriżulta f' inċidenza akbar ta 'deformitajiet, imma l- ebda anormalitajiet tal- fetu ma ġew osservati meta ingħataw dożi iżgħar.
Microcrystalline cellulose (E460), sodium starch glycollate, colloidal silicon dioxide, magnesium stearate
Microcrystalline cellulose (E460), sodium starch glycollate, colloidal silicon dioxide, magnesium stearate
Tablet film coat:
Rita tal- pillola:
Hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80
Hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80
Do not store above 30°C
Taħżinx f' temperatura ‘ l fuq minn 30°C
6.5 Nature and content of container
6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
Tamper-evident cartons containing opaque polyvinyl chloride/ foil blister packs or white high density polyethylene (HDPE) bottle with a child-resistant closure.
Kaxex li juru jekk ġewx mittiefsa li jkun fihom pakketti b' folji opaki tal- polyvinyl chloride/ fojl jew flixkun abjad tal- ployethylene ta ’ densita 'għolja (HDPE) li jingħalaq b’ tapp li ma jinfetaħx faċilment mit- tfal.
Each pack type contains 60 film-coated tablets.
Kull pakkett ikun fih 60 pilloli miksijin b' rita.
6.6 Special precautions for disposal
6. 6 Prewkazzjonijiet speċjali li għandhom jittieħdu meta jintrema
No special requirements
L- ebda ħtiġijiet speċjali.
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA 'L- AWTORIZZAZJONI GĦAT- TQEGĦID FIS- SUQ
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN Renju Unit
MARKETING AUTHORISATION NUMBER(S)
NUMRU TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA' L- AWTORIZZAZZJONI
18 March 2003
18 ta 'Marzu, 2003
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 tinstab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /
16 A.
16 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA 'L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Name and address of the manufacturer(s) responsible for batch release
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Glaxo Operations U. K Limited, (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom
Glaxo Operations U. K Limited, (jinnegozja bħala Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Renju Unit
or
jew
Grunwaldzka 189 60-322 Poznan Poland
Grunwaldzka 189 60- 322 Poznan Polonja
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat.
• 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
Summary of Product Characteristics, 4.2)
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2)
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
• OTHER CONDITIONS
KUNDIZZJONIJIET OĦRA
Pharmacovigilance System The MAH must ensure that the system of pharmacovigilance, as described in version 6.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ Farmakoviġilanza L- MAH għandu jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 6. 2 ippreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għat- Tqegħid fis- Suq, hija f’ postha u tiffunzjona qabel u waqt li l - prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 01 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar il- Maniġġjar ta ’ Riskju L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza ddettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 01 tal- Pjan dwar il- Maniġġjar ta ’ Riskju (RMP) ippreżentat fit- Taqsima 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u fl- aġġornament sussegwenti tal- RMP miftehma mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
L- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien tar- Rapport ta ’ Sigurtà Aġġornat Perjodikament (PSUR) li jmiss, skond ir- regolament tas- CHMP dwar Sistemi għal Maniġġjar ta ’ Riskji għal prodotti mediċinali għall- użu fil- bniedem.
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities.
Barra minn hekk, RMP aġġornat għandu jiġi ppreżentat:  Meta tasal informazzjoni ġdida li jista ’ jkollha effett fuq l- ispeċifikazzjoni tas- sigurtà kurrenti, 18  Fi żmien 60 ġurnata wara li tkun intlaħqet xi mira importanti (ta ’ farmakoviġilanza jew ta ’ tnaqqis ta ’ riskji)  Fuq talba ta ’ l- EMEA
19 A.
19 ANNESS III
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA
Combivir 150 mg/ 300 mg film-coated tablets Lamivudine/ zidovudine
Combivir 150mg/ 300mg pilloli miksijin b’ rita Lamivudine/ zidovudine
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVI
Each film-coated tablet contains lamivudine 150 mg zidovudine 300 mg
Kull pillola miksija b' rita fiha lamivudine 150 mg zidovudine 300 mg
60 film-coated tablets Scored tablet
60 pillola miksijin b’ rita Pillola mmarkata biex tinqasam min- nofs
Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
Oral use
Jittieħed mill- ħalq
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MINN TFAL
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
Do not store above 30°C
Taħżinx f' temperatura 'l fuq minn 30°C
Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Greenford Middlesex UB6 0NN Renju Unit
MARKETING AUTHORISATION NUMBER(S)
NUMRU/ I TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE LABEL
TIKKETTA TA ’ FUQ IL- FLIXKUN
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BLISTER PACK OUTER CARTON
PAKKETT BLISTER KARTUNA TA ’ BARRA
60 film-coated tablets Scored tablets
60 pillola miksijin b’ rita Pilloli mmarkati biex jinqasmu minn nofs
EU/ 1/ 98/ 058/ 001
EU/ 1/ 98/ 058/ 002
26 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TA 'SID L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
28 PACKAGE LEAFLET-:
FULJETT TA 'TAGĦRIF
INFORMATION FOR THE USER
29 FULJETT TA 'TAGĦRIF:
Combivir 150 mg/ 300 mg film-coated tablets Lamivudine/ zidovudine
Combivir 150mg/ 300mg Pilloli miksijin b' rita Lamivudine/ zidovudine
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew b' attenzjoni dan il- fuljett kollu qabel ma 'tibda tieħu din il- mediċina.
- Keep this leaflet, you may need to read it again.
Jista 'jkollok bżonn terġa' taqrah
It may harm them even
Tista 'tagħmlilhom
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Combivir is and what it is used for 2.
X' inhu Combivir u għalxiex jintuża 2.
Before you take Combivir 3.
Qabel ma tieħu Combivir 3.
How to take Combivir 4.
Kif għandek tieħu Combivir 4.
Possible side effects 5.
X' effetti oħra jista ’ jkollu 5.
How to store Combivir 6.
Kif taħżen Combivir 6.
WHAT COMBIVIR IS AND WHAT IT IS USED FOR
X' INHU COMBIVIR U GĦALXIEX JINTUŻA
Combivir belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Combivir jifforma parti minn grupp ta 'mediċini antivirali, magħrufin ukoll bħala antiretrovirali, li jissejħu inibituri tar- reverse transcriptase b’ analogi nuklejosidi (NRTI).
These are used to treat Human Immunodeficiency Virus (HIV) infection.
Dawn jintużaw fil- kura ta 'l - infezzjoni mill- Virus ta' l- Immunodefiċjenza (HIV) fil- bniedem.
Combivir is used in antiretroviral combination therapy for the treatment of HIV infection in patients weighing more than 14 kg.
Combivir jintuża fit- terapija kkombinata antiretrovirali għall- kura ta 'l- infezzjoni HIV f’ pazjenti li jiżnu aktar minn 14kg.
Combivir reduces the amount of HIV virus in your body, and keeps it at a low level.
Combivir inaqqas l- ammont ta 'virus ta' l- HIV fil- ġisem, u jżommu f' livell baxx.
It also increases CD4 cell counts.
Iżid ukoll l- għadd taċ- 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 tad- demm, li huma importanti biex iżommu sistema immuni b' saħħitha għall- ġlieda kontra l- infezzjoni.
Combivir has been shown to significantly reduce the risk of disease progression.
Combivir wera li jnaqqas sostanzjalment ir- riskju li l- marda tidħol 'il ġewwa.
Response to treatment with Combivir varies between patients.
Ir- reazzjoni għall- kura b’ Combivir tvarja bejn pazjent u ieħor.
Your doctor will be monitoring the effectiveness of your treatment.
It- tabib tiegħek jimmonitorja l- effett tal- kura tiegħek.
BEFORE YOU TAKE COMBIVIR
QABEL MA TIEĦU COMBIVIR
Do not take Combivir
Tieħux Combivir
- If you are hypersensitive (allergic) to lamivudine or zidovudine or any of the other ingredients of
- jekk tbati minn sensittivita 'eċċessiva (allerġija) għal lamivudine jew għal zidovudine jew għal
Combivir tablets.
xi wieħed mis- sustanzi l- oħra li jinsabu fil- pilloli ta ’ Combivir
- If you have very low red blood cell count (severe anaemia) or very low white blood cell count
- jekk għandek l- għadd taċ- ċelluli il- ħomor tad- demm baxx ħafna (anemija severa) jew l- għadd
(neutropenia).
taċ- ċelluli l- bojod tad- demm baxx ħafna (newtropenja)
If you are not sure please ask your doctor.
Jekk m' intix ċert jekk jogħġbok staqsi lit- tabib tiegħek.
Take special care with Combivir
Oqgħod attent ħafna b’ Combivir
Discuss the use of Combivir with your doctor if you have kidney or liver disease to ensure the doses of the active substances in Combivir are suitable for you.
Ikkonsulta mat- tabib tiegħek dwar l- użu ta ’ Combivir jekk għandek xi mard fil- kliewi jew fil- fwied biex tkun żgur li d- dożi tas- sustanzi attivi fil- Combivir huma tajba għalik.
It is important that your doctor knows about all your symptoms even if you think they are not related to HIV infection.
Hu importanti li t- tabib tiegħek ikun jaf bis- sintomi kollha tiegħek anki jekk taħseb li m' għndhomx x' jaqsmu ma 'l- infezzjoni HIV.
Your doctor may decide to prescribe lamivudine or zidovudine as separate medicines instead of Combivir.
It- tabib għandu mnejn jiddeċiedi li jagħtik lamivudine jew zidovudine separatament flok Combivir.
29 Anaemia (low red blood cell count) and neutropenia/ leucopenia (low white blood cell count) may occur within 4-6 weeks due to treatment with zidovudine, one of the active substances in Combivir.
30 L- anemija (għadd baxx taċ- ċelluli l- ħomor tad- demm) u n- newtropenja/ lewkopenja (għadd baxx taċ - ċelluli l- bojod tad- demm) jistgħu jitfaċċaw fi żmien 4- 6 ġimgħat minħabba l- kura b’ zidovudine, wieħed mis- sustanzi attivi ta ’ Combivir.
If severe, your physician may stop treatment with Combivir.
Jekk ikunu severi, t- tabib għandu mnejn iwaqqaflek il- kura b’ Combivir.
This has occurred more commonly in patients with advanced HIV disease and with higher doses of zidovudine than the dose in Combivir.
Dan seħħ l- aktar f' pazjenti b' HIV avvanzata u f' dożi għolja ta 'zidovudine milli bid- dożi ta ’ Combivir.
Regular blood tests will be arranged to check whether there is a problem with your white and red blood cell count.
Għandhom isiru testijiet tad- demm regolari biex ikun jista ’ jiġi kkonfermat jekk hemmx xi problema bl- għadd taċ- ċelluli bojod jew ħomor tiegħek.
This adverse reaction is infrequent in patients with early HIV disease and blood tests may be performed less frequently.
Din ir- reazzjoni avversa mhix frekwenti f' pazjenti fl- ewwel stadji ta 'l- HIV u t- testijiet tad- demm jistgħu jsiru inqas spiss.
If you take ribavirin and zidovudine together it may cause or worsen anaemia.
Jekk tieħu ribavirin u zidovudine flimkien jista ’ jikkawża anemija jew iġagħla tmur għal agħar.
Please contact your doctor if you notice symptoms of anaemia (such as tiredness and shortness of breath).
Jekk jogħġbok ikkuntatja lit- tabib tiegħek jekk tinnota sintomi ta ’ anemija (bħal għejja u qtigħ ta ’ nifs).
Your doctor will advise you whether you should stop taking Combivir.
It- tabib tiegħek jagħtik parir fuq jekk għandekx tieqaf tieħu Combivir.
The class of medicines to which Combivir belongs (NRTIs) can cause a condition called lactic acidosis, together with an enlarged liver.
Il- klassi ta 'mediċini li Combivir jifforma parti minnha (NRTI) jistgħu jikkawżaw kundizzjoni li tissejjaħ aċidożi lattika, barra minn tkabbir tal- fwied.
Lactic acidosis, if it occurs, usually develops after a few months of treatment.
L- aċidożi lattika, jekk titfaċċa, normalment tiżviluppa wara ftit xhur ta 'din il- kura.
Deep, rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of lactic acidosis.
Nifs mgħaġġel u qawwi, telqa, u sintomi mhux speċifiċi bħal dardir, remettar, u uġigħ fl- istonku, jistgħu jindikaw li qed tiżviluppa l- aċidożi lattika.
This rare, but serious side effect occurs more often in women, particularly if very overweight.
Dan l- effett rari iżda serju jiġri l- aktar fin- nisa, speċjalment f' nisa ħoxnin.
If you have liver disease you may also be more at risk of getting this condition.
Jekk tbati minn xi mard tal- fwied tista 'wkoll tkun f' riskju akbar li tiżviluppalek din il- kundizzjoni.
While you are being treated with Combivir, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Meta tkun qed tieħu Combivir, it- tabib tiegħek jeżaminak sew għal xi sinjali li jistgħu juru l- iżvilupp ta 'l- aċidożi lattika.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
Ridistribuzzjoni, akkumulazzjoni jew tnaqqis ta 'xaħam tal- ġisem jistgħu iseħħu f' pazjenti li jkunu fuq terapija antiretrovirali kkombinata.
Contact your doctor if you notice changes in body fat.
Kellem lit- tabib tiegħek jekk tara xi bidliet fix- xaħam tal- ġisem.
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.
Xi pazjenti bl- infezzjoni ta ’ l- HIV avvanzata (AIDS) u b’ passat mediku ta ’ infezzjoni opportunistika, jista jkollhom sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet ta ’ qabel fi ftit żmien wara li tkun bdiet il- kura kontra l- HIV..
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.
Jaħsbu li dawn is- sintomi huma dovuti għat- titjib fir- rispons immuni tal- ġisem, li jgħin lill- ġisem jiġġieled kontra infezzjonijiet li seta ’ kien hemm qabel mingħajr sintomi.
If you notice any symptoms of infection, please inform your doctor immediately.
Jekk tinduna b’ xi sintomi ta ’ infezzjoni, jekk jogħġbok għarraf lit- tabib mill- ewwel.
Please speak with your doctor if you have a history of liver disease.
Jekk jogħġbok għid lit- tabib jekk qatt kellek xi mard tal- 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 b' epatite B jew Ċ kronika li qegħdin jieħdu xi prodotti antiretrovirali huma f' riskju kbir ta 'xi effetti avversi li jistgħu iwasslu għall - mewt u jistgħu għalhekk jiġu bżonn testijiet tad- demm biex jimmonitorjaw il- funzjoni tal- fwied.
If you have a chronic hepatitis B infection, you should not stop your treatment without instructions from your doctor, as you may have a recurrence of your hepatitis.
Jekk tbati minn xi infezzjoni ta 'epatite B kronika, m' għandekx twaqqaf il- kura jekk ma jkunx qallek it- tabib, għax tista' terġa 'titfaċċalek l- epatite.
This recurrence may be more severe if you have serious liver disease.
Jekk jiġri dan, il- marda tista ’ tkun aktar qawwija jekk ikollok xi mard serju tal- fwied.
You will need to take Combivir every day.
Ikollok bżonn tieħu Combivir kuljum.
This medicine helps to control your condition and delay disease progression, but it is not a cure for HIV infection.
Din il- mediċina tgħin biex tikkontrolla l- kundizzjoni tiegħek iżda ma tfejjaqlekx l- infezzjoni ta 'l- HIV.
You may continue to develop other infections and other illnesses associated with HIV disease.
Jistgħu ikomplu jaqbduk infezzjonijiet u mard ieħor assoċjat mal- marda HIV.
You should keep in regular contact with your doctor.
Għandek iżżomm kuntatt kontinwu mat- tabib tiegħek.
Do not stop taking your medicine without first talking to your doctor.
Tieqafx tieħu l - mediċina mingħajr ma tkun kellimt lit- tabib.
Treatment with Combivir has not been shown to reduce the risk of passing HIV infection on to others by unprotected sexual contact or by blood transfer (for example, blood transfusions or sharing needles).
Il- kura b’ Combivir ma wrietx li tnaqqaslek ir- riskju li tgħaddi l- infezzjoni HIV lil ħaddieħor b' xi kuntatt sesswali mhux protett jew b' xi kontaminazzjoni tad- demm (per eżempju, trasfużjonijiet tad - demm jew użu ta ’ l- istess labar).
You should continue to use appropriate precautions to prevent this.
Għandek tibqa 'tieħu l- prekawzjonijiet xierqa biex ma tħallix li dan iseħħ.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Problemi fl- għadam Xi pazjenti li jkunu fuq terapija antiretrovirali kkombinata jistgħu jiżviluppaw marda fl- għadam imsejħa osteonekrożi (tmermir tat- tessuti ta ’ l- għadam ikkawżata minn nuqqas ta ’ demm fl- għadam).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul ta ’ terapija antiretrovirali kkombinata, l- użu ta ’ kortikosterojdi, il- konsum ta ’ l- alkoħol, immunosuppressjoni gravi, indiċi ogħla tal- piż tal- ġisem, fost affarijiet oħra, jistgħu ikunu ftit mill - ħafna fatturi ta ’ riskju ta ’ l- iżvilupp ta ’ 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 ’ osteonekrożi huma ebusija fil- ġogi, uġigħ (speċjalment fl- għadam tal- ġenbejn, fl- irkobbtejn u fl- ispalel) u diffikulta` fil- moviment.
If you notice any of these symptoms please inform your doctor.
Jekk tinduna b’ xi sintomu minn dawn jekk jogħġbok kellem lit- tabib.
30 Taking other medicines
31 Meta tieħu mediċini oħra
It is important that you tell your doctor about all the medicines you are taking including those you have bought yourself.
Huwa importanti li tgħid lit- tabib bil- mediċini kollha li tkun qed tieħu inklużi dawk li tkun xtrajt int stess.
These may affect the action of Combivir, or Combivir may affect their action.
Dawn jistgħu jaffettwaw kif jaħdem Combivir, jew Combivir jista ’ jkollu effett fuqhom.
Combivir should not be taken with high doses of co-trimoxazole, or injections of ganciclovir or foscarnet, as lamivudine, one of the active substances in Combivir may interact with these.
Combivir m' għandux jittieħed ma ’ zalcitabine, ma 'dożi qawwija ta' co- trimoxazole, jew ma 'injezzjonijiet tal- ganċiklovir jew foscarnet, għax lamivudine, wieħed mis- sustanzi attivi ta ’ Combivir.
Combivir should also not be taken with stavudine, as zidovudine the other active substance in Combivir may reduce the action of this medicinal product.
Combivir m' għandux jittieħed ukoll ma ’ stavudine, għax zidovudine, is- sustanza l- oħra ta ’ Combivir, jista ’ jnaqqas l- azzjoni ta 'dan il- prodott mediċinali.
Zidovudine, may also interact with the following medicines and may make any side effects worse:
Zidovudine jista ’ jagħmel interazzjoni ukoll mal- mediċini li ġejjin u dan jista’ jfisser li l- effetti sekondarji jkunu aktar agħar:
Phenytoin, probenecid, rifampicin, atovaquone, valproic acid, methadone, dapsone, pentamidine, pyrimethamine, co-trimoxazole, fluconazole, amphotericin, flucytosine, ganciclovir, interferon, clarithromycin, vincristine, vinblastine and doxorubicin.
Phenytoin, probenecid, rifampicin, atovaquone, valproic acid, methadone, dapsone, pentamidine, pyrimethamine, co- trimoxazole, fluconazole, amphotericin, flucytosine, ganciclovir, interferon, clarithromycin, vincristine, vinblastine u doxorubicin.
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 fi żmien qasir, għandek tkellem lit- tabib tiegħek biex tiddiskuti l- eventi avversi li jistgħu jiġru u l- benefiċċji u r- riskji tat- terapija antiretrovirali tiegħek lilek u lit- tarbija tiegħek.
If you have taken Combivir during your pregnancy, your doctor may request regular visits to monitor the development of your child.
Jekk tkun ħadt Combivir waqt it- tqala, it- tabib jista ’ jitlob visti regolari biex josserva l- iżvilupp tat - tarbija tiegħek.
Such visits may include blood tests and other diagnostic tests.
Jistgħu isiru xi testijiet tad- demm jew testijiet oħra waqt dawn il- visti.
In children whose mothers 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.
Fi tfal fejn l- omm tkun ħadet nukleosidi u analogi tan- nukleotidi waqt it- tqala, huwa akbar il - benefiċċju minħabba li tnaqqas iċ- ċans ta ’ xi infezzjoni milli huwa r- riskju li ssoffri xi effetti mhux mixtieqa.
If you are breast-feeding please inform your doctor before taking any medicines.
Fil- każ li qed tredda ’ jekk jogħġbok kellem lit- tabib qabel ma tieħu xi mediċini.
Combivir is not recommended if you are breast-feeding.
Combivir mhux irrakkomandat jekk qed tredda '.
It is recommended that HIV infected women do not breast- feed their infants under any circumstances in order to avoid transmission of HIV.
Hu rrakkomandat li, fl- ebda ċirkostanza, nisa nfettati bl- HIV m' għandhom ireddgħu lit- trabi tagħhom biex hekk jevitaw li jgħaddulhom l- HIV.
HOW TO TAKE COMBIVIR
KIF GĦANDEK TIEĦU COMBIVIR
Always take Combivir exactly as your doctor has told you.
Dejjem ħu Combivir preċiżament kif jgħidlek it- tabib.
You should check with your doctor or pharmacist if you are not sure.
Kellem lit- tabib jew lill- ispiżjar tiegħek meta ma tkunx ċert.
Swallow Combivir tablets with water.
Ibla ’ l- pilloli ta ’ Combivir ma ’ l- ilma.
The tablets can be taken with or without food.
Il- pilloli jistgħu jittieħdu ma ’ l- ikel jew fuq stonku vojt.
If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
Jekk ma tistax tibla ’ l- pillola( i), tista ’ tfarrakhom u tħallathom ma ’ ammont żgħir ta ’ ikel jew xorb, u ħu d- doża kollha mill- ewwel.
The usual dose of Combivir for adults and adolescents weighing at least 30 kg is one tablet twice a day.
Id- doża normali ta 'Combivir għall- adulti u għall- adolexxenti li jiżnu almenu 30kg hi pillola waħda darbtejn kuljum.
For children weighing between 21 kg and 30 kg the recommended oral dose of Combivir is one-half tablet taken in the morning and one whole tablet taken in the evening.
Għal tfal li jiżnu bejn il- 21kg u t- 30kg id- doża orali rrakkomandata ta ’ Combivir hija ta ’ nofs pillola filgħodu u pillola sħiħa filgħaxija.
For children weighing 14 kg to 21 kg the recommended oral dose of Combivir is one-half tablet taken twice daily.
Għal tfal li jiżnu bejn l- 14kg u 21kg id- doża orali rrakkomandata ta ’ Combivir hija ta ’ nofs pillola darbtejn kuljum.
Each dose of Combivir should be taken approximately 12 hours apart.
Kull doża ta 'Combivir għandha tittieħed bejn wieħed u ieħor b' differenza ta' 12- il siegħa.
For children weighing less than 14 kg, lamivudine and zidovudine should be taken as separate formulations according to the prescribed dosing for these products.
Għal tfal li jiżnu anqas minn 14kg, lamivudine u zidovudine għandhom jittieħdu bħala formulazzjonijiet separati skond id- doża preskritta għal dawn il- prodotti.
A liquid formulation is available for both lamivudine and zidovudine for the treatment of patients unable to take tablets.
Hemm formulazzjoni likwida kemm ta ’ lamivudine kif ukoll ta ’ zidovudine għall- kura ta 'pazjenti li 32 ma jistgħux jieħdu l- pilloli.
31 If your doctor wishes to reduce your dose of Combivir, for example if you have kidney problems, then your medicine may be changed to lamivudine and zidovudine taken as separate medicines, which are available as tablets or liquid.
Jekk it- tabib jiddeċiedi li jnaqqaslek id- doża ta ’ Combivir, per eżempju jekk ikollok xi mard fil- kliewi, f’ dak il- każ il- mediċina tiegħek tista ’ tinbidel għal lamivudine jew zidovudine bħala mediċini separati li jiġu bħala pilloli jew likwidu.
If you take more Combivir than you should Accidentally taking too much Combivir is unlikely to cause any serious problems.
Jekk tieħu aktar Combivir milli suppost Jekk aċċidentalment tieħu aktar Combivir milli suppost mhux probabbli li jkollok xi problemi serji.
However, you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Madankollu, għandek tgħid b' dan lit- tabib jew lill- ispiżjar tiegħek, jew tikkuntattja d- dipartiment ta 'l - emerġenza ta' sptar qrib tiegħek biex tingħata parir.
If you forget to take Combivir If you forget to take a dose of Combivir, take it as soon as you remember and then continue as before.
Jekk tinsa tieħu Combivir Jekk tinsa tieħu xi doża ta ’ Combivir, ħudha malli tiftakar imbagħad kompli bħal qabel.
Do not take a double dose to make up for a forgotten dose.
Tieħux doża doppja biex tpatti għal xi dożi individwali li tkun insejt tieħu.
Like all medicines, Combivir can cause side effects, although not everybody gets them.
Bħall- mediċini kollha, Combivir jista ’ jkollu effetti oħra.
When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Combivir, by other medicines you are taking at the same time or by the HIV disease.
Meta tkun qed tikkura l- infezzjoni HIV, mhux dejjem ikun possibbli tgħid li xi effetti mhux mixtieqa li tħoss ikunu kkawżati minn Combivir, minn xi mediċini oħra li tkun qed tieħu fl- istess ħin jew mill- marda ta 'l- HIV.
For this reason it is very important that you inform your doctor about any changes in your health.
Għalhekk hu importanti ħafna li tgħid lit- tabib tiegħek b' xi bidliet li jistgħu iseħħu f' saħħtek.
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
It- terapija antiretrovirali kkombinata tista ’ tikkawża bidliet fil- forma tal- ġisem minħabba tibdil fid - distribuzzjoni tax- xaħam.
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly), and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘ buffalo hump’).
Dawn jistgħu jinkludu tnaqqis ta 'xaħam fis- saqajn, fid- dirgħajn u fil- wiċċ, żjieda ta' xaħam fl- addome (żaqq) u organi interni oħra, tkabbir tas- sider u għoqod tax- xaħam wara l - għonq ('buffalo hump').
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża u l- effetti fit- tul ta 'dawn il- kundizzjonijiet fuq is- saħħa s' issa għad mhumiex magħrufa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
It- terapija antiretrovirali kkombinata tista 'wkoll tikkawża żieda ta' l- aċidu lattiku u zokkor fid- demm, iperlipemja (żieda ta 'xaħam fid- demm) u reżistenza għall- insulina.
Very common side effects.
Effetti sekondarji komuni ħafna.
These may affect more than than 1 user in 10.
Dawn jistgħu jaffettwaw aktar minn 1 kull 10 persuni.
Headache and nausea.
Uġigħ ta 'ras u dardir.
Common side effects.
Effetti sekondarji komuni.
These may affect 1 to 10 users in 100.
Dawn jistgħu jaffettwaw minn 1 sa 10 persuni kull 100.
Vomiting, stomach pain, diarrhoea, increase in certain liver enzymes, joint pain, muscle pain and other muscle disorders, dizziness, tiredness, difficulty sleeping, hair loss, anaemia (low red blood cell count) and neutropenia (low white blood cell count).
Remettar, uġigħ fl- istonku, dijarrea, żieda f' ċerti enzimi tal- fwied, uġigħ fil- ġogi, uġigħ fil- muskoli u problemi oħra muskolari, sturdamenti, għeja, diffikulta biex torqod, xagħar jaqa ', anemija (għadd baxx taċ- ċelluli l- ħomor) u newtropenja (għadd baxx taċ- ċelluli l- bojod).
If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness and a reduction in your white blood cell count can make you more prone to infection.
Jekk in- numru taċ- ċelluli l- ħomor tad- demm jonqoslok jista ’ jkollok sintomi ta 'għeja jew qtugħ ta' nifs u tnaqqis fl- għadd ta 'ċelluli l - bojod tad- dejjem jistgħu jagħmluk aktar suxxettibbli għal xi infezzjoni.
Uncommon side effects.
Effetti sekondarji mhux komuni.
These may affect 1 to 10 users in 1,000.
Dawn jistgħu jaffettwaw minn 1 sa 10 persuni kull 1, 000.
Flatulence, breathlessness, rash (red, raised or itchy), fever, general aches and pains and reduction in platelets (blood cells important for blood clotting).
Gass fl- istonku, qtugħ ta 'nifs, raxx (aħmar, imqabbeż jew jieklok), deni, uġigħ mal- ġisem u tnaqqis ta' plejtlits (ċelluli tad- demm importanti biex jagħqad id- demm).
If you have a low platelet count you may notice that you bruise more easily.
Jekk ikollok għadd baxx ta 'plejtlits aktarx tintebaħ li sirt titbenġel malajr.
Rare side effects.
Effetti sekondarji rari.
These may affect 1 to 10 users in 10,000.
Dawn jistgħu jaffettwaw minn 1 sa 10 persuni kull 10, 000.
Cough, nasal symptoms, patchy colour changes inside the mouth, heartburn, chest pain (possibly indicating a heart muscle disease called cardiomyopathy), breakdown of muscle tissue, liver disorders such as enlarged liver, fatty liver, inflammation of the liver (hepatitis), inflammation of the pancreas, nail and skin colour changes, sweating, flu-like feeling, drowsiness, passing urine more frequently, breast enlargement in male patients, chest pain, chills, loss of appetite, taste changes, tingling in the limbs, seizures, inability to concentrate, depression and feeling anxious, increase of lactic acid in the body known as lactic acidosis (see Take special care with Combivir).
Sogħla, sintomi ta ’ l- imnieħer, rqajja ’ fil- ħalq b' kulur mibdul, ħruq ta ’ stonku, uġigħ fil- qafas tas- sider (li jista ’ 'jindika marda fil- muskolu tal- qalb msejħa kardjomijopatija), kollass tat- tessuti muskolari, disturbi fil- fwied bħal tkabbir tal- fwied, xaħam fil- fwied, infjammazzjoni tal- fwied (epatite), infjammazzjoni tal- frixa, bdil ta' kulur tad- dwiefer u l- ġilda, għaraq, sensazzjoni bħal ta 'l- influwenza, telqa, tagħmel l- awrina aktar spiss, tkabbir tas- sider f' pazjenti rġiel, uġigħ fil- qafas tas- sider, tkexkix ta ’ bard, nuqqas ta' aptit, bidliet fit- togħma, tnemnim fid- dirgħajn u r- riġlejn, attakki ta 'puplesija,
32 While many of the side effects that have been reported occur with both lamivudine and zidovudine when given as separate medicines, some are more likely to occur with one of the medicines only.
Waqt li ħafna mill- effetti sekondarji li ġew irrappurtati jseħħu meta lamivudine u zidovudine jingħataw separatament, hemm xi wħud li aktarx huma kkawżati minn waħda biss minn dawn il - mediċini.
Your doctor may decide that you need to stop taking Combivir and take lamivudine and zidovudine separately.
It- tabib tiegħek għandu mnejn jiddeċiedi li jwaqqaflek Combivir u jagħtik lamivudine u zidovudine separatament.
This will allow your doctor to vary the dose or stop one of the active substances if it is considered that this will help manage any side effects.
Dan jippermetti lit- tabib li jvarjalek id- doża jew li jwaqqaflek xi waħda mis- sustanzi jekk iħoss li dan ikun ta 'għajnuna fil- maniġġar ta' xi effetti sekondarji.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi effetti imorru għall- agħar jew jekk xi effetti ma jissemmewx f' dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek
HOW TO STORE COMBIVIR
KIF TAĦŻEN COMBIVIR
Keep out of the reach and sight of children.
Tħallihx fejn jistgħu jilħquh jew jarawh it- tfal
Do not use Combivir after the expiry date which is stated on the container.
Tużax Combivir wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Do not store above 30oC.
Taħżnux f' temperatura ‘ l fuq minn 30°C.
What Combivir contains
X’ fih Combivir
− −
- Is- sustanzi l- oħra huma:
The active substances are lamivudine 150 mg and zidovudine 300 mg.
magnesium stearate, colloidal silicone dioxide
The other ingredients are: - tablet core; microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate, colloidal silicon dioxide - tablet film-coat; hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.
- ir- rita tal- pillola: hypromellose, titanium dioxide, macrogol 400 u polysorbate 80
What Combivir looks like and contents of the pack
Id- Dehra ta ’ Combivir u l- kontenuti tal- pakkett:
Combivir film-coated tablets are provided in tamper evident blister packs containing 60 tablets.
Combivir pilloli miksijin issibhom f’ pakketti blister tamper evident, li fih 60 pillola.
They are white to off-white, capsule-shaped scored tablets marked with the code GXFC3 on both sides.
Huma bojod għal bojod fil- griż, pilloli forma ta ’ kapsuli mmarkati bil- kodiċi GXFC3 fuq iż- żewġ naħat.
Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Manufacturer
Manifattur
Marketing Authorisation Holder
Sid l- Awtorizzazzjoni għall- Kummerċ
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street Ware Herts SG12 0DJ United Kingdom
Glaxo Wellcome Operations Priory Street Ware Herts SG12 0DJ Renju Unit
Glaxo Group Ltd Greenf ord Road Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN Renju Unit
GlaxoSmithKline Pharmaceuticals S.A. ul.
34 GlaxoSmithKline Pharmaceuticals S. A. ul.
33 For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
Għal aktar tagħrif dwar dan il- prodott mediċinali jekk jogħġbok kellem lir- rappreżentant lokali ta 'Sid l- Awtorizzazzjoni għall- Kummerċ.
Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk Deutschland GlaxoSmithKline GmbH & Co.
Nederland Danmark GlaxoSmithKline BV GlaxoSmithKline Pharma A/ S Tel: + 31 (0) 30 6938100 Tlf: + 45 36 35 91 00 nlinfo@ gsk. com info@ glaxosmithkline. dk Deutschland GlaxoSmithKline GmbH & Co.
Τηλ: + 30 210 68 82 100 España GlaxoSmithKline, S.A.
Tel.: + 48 (0) 22 576 9000 Τηλ: + 30 210 68 82 100 España GlaxoSmithKline, S. A.
Simi: + 354 530 3700
35 Slovenská republika Ísland GlaxoSmithKline Slovakia s. r. o.
34 Italia GlaxoSmithKline S.p.A.
Suomi/ Finland Italia GlaxoSmithKline Oy GlaxoSmithKline S. p. A.
This leaflet was last approved in
Dan il- fuljett ġie approvat f ’
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu
Informazzjoni ddettaljata dwar dan il- prodott tinstab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /
Competact 15 mg/ 850 mg film-coated tablets.
Competact 15 mg/ 850 mg pilloli miksija b’ rita.